A National Geographic project that uses DNA to map humanity's genetic lineage is under fire from indigenous rights groups that are pressing the United Nations to halt the project.
The controversy marks the rising public profile of "biopiracy" -- a word that just entered the Oxford English Dictionary last year and loosely refers to the failure of companies and researchers to pay indigenous groups and poor governments for biological materials and ideas.
As scientists scour rainforest in search of useful things inside living beings, a growing list of developing countries and groups are moving to stop piratical pilferers -- or take a cut in their profits.
The rising biopiracy panic has even tainted companies like Google, which in March was put on the plank for its reported plans to help geneticist -- and accused "biopirate" -- Craig Venter put searchable genes online. Venter's press representative had no comment, and Google's representative said the company had no information to share.
"Biopiracy awareness is undoubtedly growing fast, so much so that you are seeing calls for an international framework to deal with the problem," said Deb Harris, a Northern Paiute activist from Nevada who directs the Indigenous Peoples Council on Biocolonialism (IPCB).
In March, a U.N. meeting in Brazil heard calls for international laws to stop biopirates and give indigenous groups benefits-sharing plans. Meanwhile, trade lawyers fight over patent laws at the World Trade Organization and the World Intellectual Property Organization. And green groups battle free trade deals like the pending agreement between biorich Peru and the United States, which critics say fails to crack down on biopirates.
But some question whether well-meaning biopiracy activists are taking the wrong road, even hindering science and useful projects.
The National Geographic's Genographic project, a nonmedical project that also lets Average Joes buy a $90 testing kit to discover their own genetic heritage, steers proceeds to a fund that helps indigenous groups. But Harris of IPCB says researchers fail to properly inform subjects before they hand over DNA samples. "The project's research protocols show they only spend 20 minutes with the test subjects getting their consent," said Harris, who has assembled hundreds of signatures from indigenous groups and is pressing a U.N. body on indigenous affairs to stop the project.
National Geographic officials are frustrated by the charges and stress that researchers even took the rare step of releasing research protocols in the name of transparency. They point out that the 20-minute window cited in the protocol alludes only to the physical sampling of blood, not the time it takes to inform and get consent, as critics claim.
"It clearly does not include the extensive time taken to make initial contact with indigenous collaborators and representatives, explain the project, receive word of enthusiasm (or not, which is fine) and then spend time setting up the further permissions to visit the region, talk to leaders and individuals whom we have been briefed are already interested, etc., which takes weeks and months," Lucie McNeil, a National Geographic spokeswoman, wrote in an email.
Share the benefits
Many indigenous groups and developing countries are calling for "contractual benefits sharing" whenever corporations make money off "research leads" or materials snatched from native habitats. Some call for new patent rights over seeds, knowledge and other things foreign companies have been known to grab. Still others reject altogether the right to patent life forms.
The crosscurrents make biopiracy, a very real and ecological destructive problem, a vague and confusing buzzword.
One challenge for biopiracy activists is getting America's shrunken attention span around the dull but crucial topic of patent law. Perhaps that's why biopiracy has a sensationalist vibe.
"Patents are socially corrosive and the whole system undermines conservation and use of biological diversity," says Hope Shand of ETC Group, which is a member of the Coalition Against Biopiracy.
As corporations probe deeper into jungles looking for the next miracle drug or food product, Washington's global push for free trade deals spreads a "predatory patent systems" that favors industrialized nations and treats nature as a commodity, say many activists.
Several famous cases of "bad patents" reveal how the U.S. patent office can hurt developing countries, especially farmers, by awarding patents for, say, beans or rice that have been grown by indigenous communities for centuries. Those cases are grist for international attempts to fix the problem. But how do the world's poorest communities make claims against corporate power and a U.S. administration loathe to protect traditional knowledge and biodiversity at the expense of big business?
Brazil, a species-rich country that has seen biopirates skedaddle with its resources, has passed domestic biopiracy laws while boosting its own scientific potential to make use of its natural endowment. According to a recent New York Times report, it has passed a law aimed at punishing those who use indigenous resources without permission, or who don't share the benefits with the state or local communities. The fines from penalties will go to conservation efforts.
Playing the patent game
Many laud the U.N.'s attention to biopiracy, particularly a draft United Nations Declaration on the Rights of Indigenous Peoples that calls for indigenous communities to own their resources such as seeds and traditional know-how. But the problem, say sympathizers like Strand and open-source technology guru Richard Stallman, is that claims to "ownership" -- while seemingly a good fix -- actually places the value on these resources as commodities. What's more, the patent game is hard for little guys to play.
"Although some indigenous peoples may promote the idea of patenting their own resources, it's usually rejected as a strategy because it's a high-stakes game, and they can't possibly compete with the deep pockets of multinational companies," says Shand.
And securing a patent calls for lawyers and budgets for litigation and applications -- something farmers and indigenous peoples don't have. Another big problem is dialing back bad patents once they've been issued. Activists point to the Enola bean, involving a U.S. patent over a traditional Mexican bean that remains in force six years, nearly a third of its 20-year lifecycle, after a legal challenge began.
Shand says the contractual benefits sharing approach requires indigenous groups to become involved in "commodifying and selling the commons and collective heritage," perhaps pitting them against the same people or inhabitants of the same region. Solveig Singleton, a lawyer with the Competitive Enterprise Institute, questions benefit sharing schemes on different grounds. She says it's understandable for indigenous groups to take a defensive posture against bad patents. But in a telephone interview she questioned "vague claims" to rights that would let them have a share of product sales that required major work and investment to take to market.
Writing in her blog, she asks: "Would these same discoverers share the risk and blame if the product were somewhere downstream found to cause birth defects or other harm? Would they also desire to share in the profits from sales of coffee, tea, and chocolate, claiming to have discovered their property of tastiness? What about the properties of coca leaves and opium poppies? Would they like to share in the profits from the development of those products into painkillers? Would they also like to share in the profits from the sales of heroin and cocaine? What about crack? Will they share in ameliorating the harms?"
While activists may disagree on the usefulness of asking for benefit-sharing schemes, they widely agree that patents like the Enola bean should be stopped before they start.
Brazil and India represent a group including Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand and other developing nations. They are calling for fixes within the present patent system, advocating that the Convention on Biodiversity (which calls for equitable benefits sharing) be fused with the WTO's patent treaty, known as TRIPS. They want governments to force patent applicants to say where they got the genetic material and traditional knowledge before issuing a ruling. They also want prior proof that local groups who helped patent applicants were properly informed and given equitable stake in the project.
Not surprisingly, the Bush administration is a no-go. They've rejected calls to strength protections for indigenous knowledge at the expense of big business, groups like Public Citizen point out. Washington wants to let domestic laws deal with biopiracy while the European Union is somewhere in the middle, saying that patent offices are not fit to determine what's fair.
The bottom line
Meanwhile, as rain forests are destroyed (by a multitude of factors), the money machine keeps on turning.
Some three-quarters of all plant-derived prescription drugs were discovered because they had once been used in indigenous medicine, according to one figure. Another says that between 1950s and 1980, drugs derived from medicinal plants consistently accounted for not less than a quarter of all prescription drug sales in the United States.
Some say the biopiracy backlash is hurting more than some corporations' image.
Thomas Lovejoy, president of the Heinz Center for Science Economics and the Environment, is a known advocate of rainforest preservation -- and a formerly accused biopirate. He was swept up in Brazil's biopiracy panic last year, even accused by some Brazilians as being a CIA operative while working in the jungle for the Smithsonian Institution. After appearing before a Brazilian congressional committee, he was eventually cleared of the charges.
"While one can understand the attention being paid to biopiracy, it in fact is fairly easy to prevent," he sad in an email. "No modern-day scientific institution would condone it, and the basic framework of intellectual property protection should be sufficient to protect national interests in the economic potential of biodiversity applications. Unfortunately in some situations the preoccupation with biopiracy borders on obsessive, and I believe does get in the way of research and the best interests of the countries involved."
So, if new patents and bilateral deals over benefit sharing aren't the way to ensure that indigenous groups and developing countries get their cut of the cake, what's the answer?
Some activists call for nonproprietary systems of benefit sharing -- multilateral frameworks in which governments support a global biodiversity fund, a kind of endowment for promoting the needs of those indigenous groups.
Can the patent genie be put back into the bottle, somehow made subordinate to biodiversity needs? Will the biopiracy label lose public relations power if misused? Is science truly being hurt? Should indigenous groups call for new rights of ownership over their natural habitat? Is seeking "contractual benefit sharing" a bad row to hoe?
Certainly Alejandro Argumedo thinks so.
In a quote attributed to him, the Quechua activist said: "Contractual benefit sharing is like waking up in the middle of the night to find your house being robbed. On the way out the door, the thieves tell you not to worry because they promise to give you a share of whatever profit they make selling what used to belong to you."
Last week, during his office hours at Pomona College in Claremont, Calif., professor Miguel Tinker Salas, a Venezuela-born historian and Bush administration critic, received an odd visit.
It had nothing to do with term papers or syllabi. In fact, the visitors didn't own a student ID card.
Channeling McCarthy-era intimidation, professor Salas greeted two members of the L.A. County Sheriff's Department/FBI Joint Task Force on Terrorism. They had a file on the U.S. academic, complete with a photo. And they had questions: Was he a U.S. citizen? What was his immigration status? Was he in contact with the Venezuelan embassy?
The event spun from blogosphere to mainstream press, prompting apologies from the FBI's Los Angeles office and birthing charges that the Bush administration is resuscitating Red Scare tactics in an effort to stem U.S. grassroots support for Venezuelan President Hugo ChÃƒÂ¡vez's socialist ideology.
Is the White House that worried about ChÃƒÂ¡vez's power? Recent weeks have brought marked amplification of Washington's Cold War of words. But top U.S. officials have zeroed in on ChÃƒÂ¡vez's international misdeeds. Intelligence Chief John Negroponte, Secretary of State Condoleezza Rice and Secretary of Defense Donald Rumsfeld continue to charge ChÃƒÂ¡vez with strong-arming opposition at home, funding rogue elements in his region and coddling Washington's top enemies abroad, including Iran and North Korea.
Last month in congressional testimony, Rice said a "policy of inoculation" was necessary to diplomatically contain Mr. ChÃƒÂ¡vez's influence in Latin America.
For his part, ChÃƒÂ¡vez has mastered the art of annoying Washington: backing Tehran's nuclear plans, wooing North Korea, extending his hand to Hamas, pushing his own civilian nuclear power plans, all while repeating threats to clamp off oil supplies to the United States.
Meanwhile, the controller of the world's fifth-largest oil exporting country is deftly seeding his image and ideology in Washington's backyard, connecting with U.S. citizens and groups that share his disdain for the Bush administration, for neoliberalism and, more generally, for globalization's myriad failures.
His message is powered by oil. Flush with petrodollars, ChÃƒÂ¡vez has offered free or discounted gas to America's poorest citizens through CITGO, a subsidiary of Venezuela's state oil company. He has floated the idea of offering free eye surgery to poor Americans while his government has helped out on local levels. In Chicago, for instance, a popular street festival Fiesta Boricua, was saved last year by a $100,000 donation from CITGO.
And he's won followers, from Jessie Jackson to Cindy Sheehan to everyday Americans from Tennessee to Utah. The Miami Herald reported in December that fifteen "Bolivarian Circles" -- the grassroots groups that form the basis of ChÃƒÂ¡vez's social revolution in Venezuela -- have sprung up in U.S. cities, including New York, Los Angeles, Cincinnati, Boston, Miami, Salt Lake City and Knoxville. Meanwhile, his government is paying a Washington lobbyist for an image buffing on Capitol Hill.
Supporters say ChÃƒÂ¡vez's "grassroots foreign policy" is a taste of Washington's own medicine, a flip side to the congressionally funded National Endowment for Democracy's support of anti-ChÃƒÂ¡vez groups in Venezuela. Washington casts ChÃƒÂ¡vez as the puppeteer of Latin America's so-called "Pink Tide," the recent rise of progressive, anti-U.S. politicians eager to distance themselves from U.S.-backed free market policies. With oil at stake and Bush at 39 percent approval ratings, does the Salas incident mark the beginnings of a Pink Scare?
In this edited transcript, professor Salas talks with Alternet.
Kelly Hearn: What do you think caused the visit? Are you currently active in groups that support Mr. ChÃƒÂ¡vez?
Miguel Salas: The only grassroots I have is my family. I'm a professor and hardly have time for anything but teaching and publishing, and trying to keep my head above water. I have a full load and am not involved in any kind of grassroots activity. I think this happened because I am an outspoken critic of U.S. policy, which has all but failed and is premised on isolating Mr. ChÃƒÂ¡vez. I am a very vociferous critic and have done so publicly in print and broadcast media. In fact, the day before they showed up, I had been on CNN en Espanol talking about the history of U.S. intervention in Latin America.
KH: Mr. ChÃƒÂ¡vez is spreading his Bolivarian revolution on a regional stage and is connecting with marginalized communities who feel ignored by the United States and hurt by neoliberal, U.S.-backed policies. He's now connecting with some Americans in a similar way. How would you characterize the potential political impact his Bolivarian Revolution might have among marginalized communities in the United States?
MS: I don't think social processes are exportable if discontent doesn't exist in the first place, the kind of protests we've seen in countries like Argentina and Bolivia. I don't think ChÃƒÂ¡vez's position will have much of an impact here. But throughout the continent, there is a great level of social discontent that's the product of 20 years of neoliberal policy.
KH: But it seems his message is at least connecting with some people here
MS: That is why the Bush administration is so nervous. It has seen its position erode significantly. They have squandered capital in Iraq, which has been disastrous. In that context we see the Patriot Act renewed, we see homeland security, we see eavesdropping
KH: And now we see agents at your door.
MS: Now we see agents in my office hours. It's like "who's coming to my office hours?" and they are not students. I'm not ready to say this marks a return to the McCarthy Era, but there are interesting parallels with the administration losing the support of the people on the verge of congressional elections and opting to use agents of the state to cause intimidation in academic circles.
KH: The Bush administration charges that Mr. ChÃƒÂ¡vez is resorting to draconian tactics, such as overreaching press laws for example, to silence critics and maintain power. What do you make of these claims?
MS: For the critics who worry about freedom of press, I would urge them to go to Venezuela and read the newspapers, which have unfettered ability to criticize and mock ChÃƒÂ¡vez. I constantly read Venezuelan newspapers and amazed at the extent to which they call him a guerrilla, a monkey, a chimpanzee, to an extent you wouldn't see in the United States. I fully support a free press, and I have not seen a muzzled press in Venezuela.
KH: There are conflicting views about the extent to which Mr. ChÃƒÂ¡vez has used petrodollars to address poverty in Venezuela, in other words, the extent to which his alternative development model really works. Has he managed to deal with institutionalized problems in your view?
MS: I think the problem is on the ground where poverty continues to increase. Fundamentally he needs to create parallel institutions. He has many plans, medical and educational and so on, but these have to be institutionalized. The key gauge is poverty alleviation. People need to see their standard of living improve, and that is fundamental to any administration. He needs to move away from missions into institutionalized arrangements by which missions take root and provide services.
KH: Economists note that developing nations that have lots of natural resources often fare worse that developing nations that don't. Is Venezuela an exception to the so-called "oil curse?"
MS: Oil is a different and unique commodity. It's not the same as coffee or copper or bananas because of the role it plays in the world economy, especially now with China and India developing and demanding access to it. This provides an opportunity that can't be squandered, an opportunity to take resources and put them back into the economy. The problem is that in Venezuela the benefits of oil have always gone to the elite and middle class.
KH: Two Republican U.S. senators recently told me off the record there was no way the United States government will militarily intervene in Venezuela. Mr. ChÃƒÂ¡vez, on the other hand, claims to have evidence that Washington is set to invade. Given the increasingly tough rhetoric coming out of Washington, as well as Venezuela's support for Tehran's nuclear plan, do you think military intervention is at all possible in the next, say, five years?
MS: It is impossible to predict. Nobody would have known a country not linked to 9/11 would have been invaded on that pretense. I could only hope Bush wouldn't go down that path because we've seen what can happen in Nicaragua and El Salvador. Any U.S. action in Venezuela would destabilize all of South America. It would be a conflict of dramatic proportion for the region and be disastrous. I hope there are level minds in Washington. But they will continue to meddle as we have seen with groups like the National Endowment for Democracy, the AFL-CIO, which has used resources in that direction, and others.
KH: A recent deal that allows U.S. troops to train on Paraguayan soil has sparked rumors that the U.S. is seeking a permanent outpost in the region to counter the so-called ChÃƒÂ¡vez-Castro axis. What do you think?
MS: The United States is militarizing Latin America. We have a legacy of dirty war throughout the continent. In the past, the U.S. trained the military in countries with clear records of human rights abuses, training individuals in the School of the Americas as well as on the continent. The U.S. has a base in Ecuador, and now they are sending troops to Paraguay. This and the recent visits to the region by Donald Rumsfeld are also a concern.
Nigeria, 1999: Government soldiers, riding in helicopters owned by Chevron Corp., fire on villages opposed to oil operations. Colombia, 1998: The Colombian Air Force, acting in the interest of U.S.-based Occidental Oil, drops a cluster bomb on the village of Santa Domingo. In Burma, government soldiers use rape, murder and torture to silence opposition to a gas pipeline project of California-based Unocal.
High petroleum prices and rising populist anger are ratcheting up human rights pressures along the world's remote pipelines. And from Burmese villagers to Nigerian farmers, Colombian environmentalists to Ecuadorian jungle dwellers, indigenous peoples in poor, resource flush nations are reaching up from the cracks and saying no to globalized oil.
Can they swing at globalized Goliaths without resorting to dangerous and limited tools of the disenfranchised to protest kidnappings and sabotage?
Enter the Alien Tort Claims Act of 1789, a two-century-old U.S. law passed to deal with international piracy and diplomatic rights. A dose of modern lawyering has dusted off ATCA in recent years, buffing it into a powerful human rights tool that offers foreign aliens access to U.S. courts in cases where corporations violate international law. Activists pitch it as a big stick for little folks, one to redress extra-judicial killings, corporate-backed torture, and genocide.
Corporations call the ATCA a faulty vector for greedy lawyers, and their lobbying has set the Bush administration and Capital Hill cronies on a quiet path to kill it.
Old problem, new spin
The law's modern rebirth started in Paraguay, in 1976, with the paintings of Dr. Joel Filartiga, a medical philanthropist and artist whose paintings, according to court documents, "depict the oppression and suffering of the people of Paraguay." On March 29, his 17-year-old son, Joel, was kidnapped by a group of policemen, including an official named Americo Norberto Pena-Irala. According to official court complaint, Pena-Irala tortured Filartiga to death and approximately four hours later summoned Filartiga's sister Dolly out of bed to look at the body, suggesting he was murdered in reprisal for her family's political stances. Pena-Irala subsequently moved to the United States and was sued by the Filartiga family under ATCA. In 1980, the family won a $10 million (but uncollected) judgment. Then, years later, came Bosnia, and a little more evolution for ATCA's new self. In 1995, a U.S. court ruled that Bosnian Serb war criminal Radovan Karadzic did not have be a government official in order to be sued under the law.
Experts say that ruling helped set the legal basis for ATCA's contemporary corporate portfolio, which has come to include suits involving the alleged events in Nigeria (Bowoto v. ChevronTexaco), Colombia (Mujica v. Occidental Petroleum) and Burma (Doe, et al. v. Unocal Corp.). Legal experts say some two dozen corporate cases have been filed, with most being dismissed on procedural grounds. But there has been a win that could put corporations and their insurers on edge. The storm appeared last year when Unocal paid an undisclosed sum (estimated to be at least over $30 million) to settle its suit. Steve Donziger, an attorney involved in an Ecuador-based multimillion dollar environmental lawsuit against Chevron Corp., said the Unocal victory "is a significant precedent that could open the courts to more such suits." He noted that the fact Unocal settled does limit the value of the case as legal precedent.
No doubt other corporations with ATCA baggage, from Union Carbide to Coca Cola to PriceWaterhouse, are watching. Even Big Pharma, the planet's other Economic Goliath, might be nervous. Its ATCA problems are embedded in Abdullahi v. Pfizer, a case in which the company is accused of opening a treatment center at the Infectious Disease Hospital in Kano, Nigeria, after a 1996 outbreak of bacterial meningitis, measles and cholera. The pharmaceutical giant allegedly used the crisis to conduct biomedical research experiments involving Pfizer's antibiotic drug Trovan on Nigerian children. The ATCA has also been used by Holocaust-era slave laborers and victims of South African apartheid.
Once a legal nuisance, the beefing of ATCA as a human rights tool is a thorn for an administration that's naturally adverse to torts, cozy with corporations and sensitive to all things petroleum-related. Unlike the Clintonian take on ATCA, which in amicus, or "friend of the court", briefs in the Karadzic case, supported the law as a key human rights tool, the current administration has attacked. It has repeatedly intervened in ATCA cases (especially involving corporate allies of the administration) "to suggest that they should not go forward based on political and diplomatic considerations, in some cases invoking the war on terrorism as a justification," says Marco Simons, U.S. Legal Director for EarthRights International, a Washington-based group helping spearhead several ATCA cases.
Kenny Bruno, a plantiffs lawyer in the Unocal case, echoed Simons. "Basically the administration has tried to get rid of it on the legal end and the business world has tried to approach Congress to change it," he said. "But legislators and judges recognize that it is an important and an option in some cases for victims of human rights violations."
Despite the desires of big business, in 2004 the Supreme Court said in Sosa v. Alvarez-Machain that ATCA was not to be a "catch all" corporate accountability law but that the door was ajar for egregious cases where acts clearly rise to defy international law.
Bruno and attorneys such as Rick Herz, a plaintiff's lawyer in Chevron's Nigeria case, says the Bush administration's "friend of the court briefs" have gone further than even the business world has asked for. Though corporation interests have not addressed ACTA's application in cases against individuals, says Bruno, the Bush administration has gone "so far as to argue that the whole law has been misapplied for its entire modern history." In Doe v. Unocal, the administration took the position that the ATCA was essentially useless, that it offered no valid vehicle for suing over human rights violations. Furthermore, notes Simons, the lawyers argued that all prior ATCA cases were wrongly decided, reversing the position the government took in Karadzic.
Corporations typically argue that human rights violations are not their doings, but those of governments. That position is reflected in the Bush administration's current legal tack: ask the courts not to recognize certain liability, specifically aiding and abetting, because doing so "could have adverse implications for U.S. foreign policy in the future," says Simons. Such a position would toss most ATCA cases, because direct violations are always committed by state forces, not by oil firms directly. Lawyers are already working to undercut that position. In the Nigerian case, plaintiffs say that even though Nigerian government did the dirty work, the abuses were "instigated, orchestrated, planned and facilitated by Shell Nigeria under the direction of the defendants," who were said to have "provided money, weapons and logistical support to the Nigerian military Ã¢â‚¬Â¦ participated in the fabrication of murder charges Ã¢â‚¬Â¦ and bribed witnesses to give testimony."
The Bush administration's ostensible reason for limiting aiding and abetting liability is filled with oil. Sources close to the Chevron case, for example, say company attorneys are pushing the judge to seek State Department opinion on the potential impact the case could have on foreign relations. Why? If past trend is followed, officials would likely seek the case's dismissal in order to preserve relations between the Washington and Nigeria, one of the world's top oil exporters. Translation: oil is a national interest that supersedes claims of human rights abuse. Though the Bush administration has filed court briefs in other ACTA cases, it has yet to file in the Chevron case.
If the courts don't give them what they want, the ATCA's opponents still have Congressional bank accounts to twist. The National Foreign Trade Council, which represents some of America's largest companies, and the International Chamber of Commerce have done so.
And they may have found sympathetic ears.
In October, Sen. Diane Feinstein proposed then retracted (under human rights fire) a bill that would have essentially gutted the ATCA's corporate potential. Neither Feinstein's office nor Chevron immediately responded to interview requests but Feinstein has received campaign cash from the oil giant, according to OpenSecrets.org. And Earthwatch points out that Sen. John Cornyn, R-Texas, and Rep. Tom Feeney, R-Fla. have introduced bills expressing the congressional position that courts should not be influenced by international law generally.
Even without congressional heat, and some favorable rulings, ATCA cases are tough to win. "It is still a major uphill battle to successfully bring an ATCA case against an American corporation for environmental damage or anything else," said Donziger, the attorney involved in the Ecuadorian lawsuit against Chevron, which began in U.S. courts as an ATCA case but was rejected by courts.
Nonetheless, the Unocal ruling scares big business, and they're likely to turn up the heat on ATCA.
"To use that one limited case as an excuse to assault the law itself shows how desperate American business is to protect itself from any accountability for human rights depredations it might be committing abroad," Donziger added.
When Evo Morales took the office of president of Bolivia on Sunday, it was notable not only as the end of a "Bolivian-style apartheid" but also for making Morales the world's No. 1 spokesman for the coca plant.
Morales, himself a former coca farmer, preached a hard line against cocaine traffickers, but at the same time he announced his intention to resist Washington's $100 million compulsion to stamp out coca farming in his grindingly poor Andean nation.
For millennia, Bolivia's indigenous groups have chewed and brewed coca leaves as a mild stimulant and appetite suppressant. But the leaf's role as the central ingredient in cocaine has made it a primary enemy of America's war on drugs. The result: hundreds of millions of U.S. tax dollars, often in the form of helicopters and planes for aerial fumigation, which kills coca crops but also ravages Bolivians' health and environment.
Morales proposed to fight the cocaine traffickers, who send the drug to satisfy the North's desires, but also insisted that the coca leaf retake its rightful place in Bolivia's cultural life. "We say no to zero coca, but we are promoting zero cocaine," Morales was quoted by newswires last week. "We are going to try to interdict the narco-traffickers."
To grow legitimate markets, experts say Morales must shoot to change global attitudes that have long mingled the benign coca leaf with cocaine's devilish reputation. Drug policy experts say it could also mean taking on America's drug hysteria and revisiting the skewed science around which coca's prohibitionist regime was built some five decades ago. And Morales' plan also gives ammunition to U.S. critics who will use his coca policies to paint his socialist agenda in even more heretical hues.
The rise and fall of the global coca market
Ranking behind Colombia and Peru as the world's third-largest coca producer, Bolivia has some 65,500 acres under cultivation, according to U.S. estimates. In 2004, eradication programs, which began in the 1980s, were largely brought to a halt in one of Bolivia's two regions that can legally cultivate coca under national law. That deal was brokered in October 2004 between coca growers, led by Morales, and then-President Carlos Mesa. Now a European Union study is underway to mark how much coca is needed to meet traditional usage. In theory, the rest of the country's crop would be slated for eradication,
Besides ending eradication programs, Morales is widely expected to push for a revival of a global coca market.
"What Evo is proposing is very legitimate and credible from a scientific, historical and marketing perspective," said Ethan A. Nadelmann, executive director of the New York City-based Drug Policy Alliance. Nadelmann says Morales may help build an international market for coca-based products, similar to those that existed in the 19th century, when coca formed part of products such as tonics and wines, even Coca-Cola for a time. In December, an Indian tribe in Colombia began marketing a soft drink made from coca plants, and recent press reports from Bolivia suggests entrepreneurs are looking for early product niches, making it easy to see a future of coca-based medicines, gums or lozenges.
The case of coca is a fine example of just how well science can serve prejudice. Its production was criminalized by a 1961 international treaty that set a 25-year moratorium on legal coca consumption. That convention, stimulatingly entitled "The Single Convention on Narcotic Drugs of 1961," prohibits coca cultivation, putting it currently at odds with Bolivia's national policy allowing a certain level of production. The convention, which also criminalizes cannabis, opium, morphine and heroin, is disliked by European countries pursuing heroin maintenance programs, and activists say Morales would do well to support any European efforts to amend that deal, as well as encourage other industrialized nations to do the same.
The Transnational Institute, a think tank based in the Netherlands, says a key scientific report that shaped coca's legal classification was flawed and needs updating to incorporate recent science. "The scientific basis for the classification of the coca leaf deserves a reevaluation by the institutions of the United Nations," states a TNI position paper. "Not only does the report not represent all the scientific studies relevant at the time, but in the half century since new evidence and knowledge has emerged in regard to traditional uses of coca, including beneficial." What's more, TNI analysts note that while an amendment to the international convention leaves room for countries to okay the traditional, licit use of coca, it prohibits licit cultivation. The underlying message is: You can take it if you've traditionally done so, but you can't grow it.
Science is on coca's side
Similar to the case of marijuana, there has long been scientific research to back claims of coca's health benefits. In 1981, Harvard-trained health guru Andrew Weil reported in the American Journal of Epidemiology that coca in leaf form does not produce toxicity or dependence and suggested its usefulness in treating gastrointestinal ailments and motion sickness. He reported that coca could aid weight-loss regimes and even act as a fast-acting antidepressant. And its power to regulate carbohydrate makes it a possible combatant for hypoglycemia and diabetes.
Such findings mean little to the prohibitionist sensibilities of Washington, which has long used the principal of conditionality to push its drug regime and suppress scientific findings it dislikes. Case in point: In 1995, the United States threatened to pull funds from the World Health Organization if it published the results of the world's largest study on cocaine, a 22-country study that also studied coca. In effect, say a range of drug policy advocates, the study was suppressed.
"The report essentially said what everyone seems to know and agree [on] with few exceptions," says Craig Reinarman, a sociologist at the University of California at Santa Cruz who worked on the study but never saw a final copy. "The gist was that coca has been around for millennia and more or less used without abuse or problems by native people of Andes regions where it grows. And with respect to refined powdered cocaine, the study found that people mostly used it as a treat, with some abuse, with some people getting into trouble but most not."
TNI has managed to recoup parts of the suppressed study. Eric E. Sterling, president of the Maryland-based Criminal Justice Policy Foundation, said Morales could link with European discontent over the 1961 convention and press to change its provisions on coca. In addition to Bolivia, several countries are carving out exceptions to the convention. The Netherlands has refused to enforce some cannabis bans, and Germany and Switzerland both have established heroin-maintenance programs. But those countries have not formally passed laws that contradict the convention. With more political capital at stake, one theory goes, Morales could take the lead in forcing a change. Sterling suggested America's faltering image abroad could thin Washington's political ability to stop efforts at reconfiguring the convention. Reinarman agreed Washington's weight may be diminished but thought it unlikely the convention would be amended.
"These countries are making lots of little exceptions, but it is difficult to overthrow the convention because the U.S. is the power behind the throne, and they will throw their weight around," he said. In Bolivia's case, throwing weight could mean denying $150 million in annual U.S. foreign and anti-drug aid to Bolivia or the country's request for $598 million in additional U.S. development assistance. With that in mind, some think Morales will tone down his hard rhetoric and try to balance U.S. wants with his domestic political needs.
"Morales must make clear to the U.S. that while he advocates coca, he will do what it takes to stop cocaine from being manufactured in Bolivia," said Adam Isacson of the Center for International Policy in Washington. "Evo no doubt intends to curb coca eradication and to develop legal coca markets. But he should be able to keep the U.S. government happy by redoubling interdiction, taking down labs and kingpins, and improving control on roads, rivers and in the air."
Balancing those interests will be a tough line, and experts say Morales most surely will have to first satisfy his domestic constituents to survive politically. The first order of business may be keeping the the U.S. eradication program stopped in its tracks.
"I can't image him staying in power if he allows the U.S. to spray large swaths of that country with a poison that kills plants and to do so with no respect for public health," Reinarman said. "Imagine if the Bolivian air force were to spray large swaths of Kentucky and Virginia to eradicate tobacco, which has killed far more people than coca. We would respond with bombers."
When former Enron executive Andrew Fastow and his wife Lea were convicted of wire and securites fraud, the judge staggered their sentences so not to leave their children without a parent.
Millions of other American kids aren't so lucky.
A reprehensible number of children of prisoners in the United States have been left parentless in recent years thanks in large part to overreaching mandatory sentencing laws. Often poor, psychologically scarred and prone to generational cycles of criminality, their numbers grow with the industrial prison complex, itself an offspring of fear, profit and politically motivated "wars" on drugs and crime.
More than 2.2 million citizens are behind bars, a fivefold spike over three decades. The Sentencing Project, a Washington D.C.-based watchdog group, reports that the lifer population in U.S. prisons has more than tripled in the past two decades. One in every 11 federal and state prisoners now carries a life sentence. And one in four is serving a sentence of 20 years or more.
And the children bear the costs. Many must rely on grandmothers, elderly women who are often in poor health and financially struggling. Other kids fall into bureaucratic mazes or shuttle between foster homes. Too many take to the street, uncorrected problems becoming fountains for new ones.
- 2.4 million American children have a mom or dad in jail.
- Three in every hundred American children have a parent behind bars.
- The number of incarcerated women (many of them mothers) increased more than sevenfold between 1980 and the end of 2003, from 13,400 to over 100,000, according to the General Accounting Office.
In an age of fear factor politicking, can the U.S. combat crime while keeping families together? Can society protect family bonds by softening mandatory sentencing laws passed during America's crack hysteria of the 1980s? In short, can the American criminal justice system be taught to think?
Journalist Nell Bernstein says yes. In her new book, All Alone in the World, Bernstein deftly uses studies, interviews, policy recommendations and tragic personal stories to map the damage our criminal justice system has done to the people it may too likely house in the future.
You note that some have called over-incarceration the civil rights issue of the 21st century. You've suggested it may also be the children's issue of our time. If a new civil rights movement is to emerge, where does it best begin and who is most likely to start it?
I think the interesting thing is that civil rights movements only work when led by those affected. There is definitely a movement brewing on the part of former prisoners looking at lots of things including the legal denial of civil rights. But when it comes to children it's hard. Obviously young children can't lead or participate. There are teenagers, young adults, who have experienced this who are powerful leaders and voices, but there is still a lot of stigma. Almost more than anything else I've written about, there is a hesitancy to talk about it.
You report how overly punitive drug laws are responsible for leaving many children parentless. What in your opinion has lead to the contemporary American hysteria that prefers retribution to rehabilitation?
I think there are lots of things that contribute to it. But I also don't think most people think that way anymore. What's really interesting is that recent polls have showed people turning toward rehabilitation. That wasn't true 10 years ago when there was a real lock-em'-up attitude. The politics hasn't caught up though.
One problem is that people don't know who's in prison. People assume if you go to prison you are dangerous and you should be in prison. They don't realize that a large percent of prisoners are drug offenders or people who committed nonviolent crimes. Politicians explained to me that you can oppose a tough-on-crime law when it is being voted on, but once it is enacted it is immovable. Polls are showing a shift in public opinion and my hope is that it will filter into politics.
You mention psychologist Robert Coles' theory of the "moral jeopardy" faced by children. Can you expand on that?
I tried to talk to young people to see how they developed morally when they felt their family had been treated unjustly by law enforcement or the criminal justice system. Besides the sentences, these are kids who sometimes have been treated roughly themselves. Some say kids living in extreme hardship run the risk of losing their moral compass. I wanted to look at this in kids who had reason not to trust social contract. And I found that they were morally complex, struggling to do the right thing and understand what was right even in the face of complex circumstances.
You call for arrest protocols that support and protect arrestees' children, the idea being to train police to comfort children during the psychologically dangerous moments of a parent's arrest. How would you describe the current state of police preparedness in this regard?
I am not sure police could comfort them. It could be difficult to draw comfort from the people who are taking your parent away. But they can help them at the most basic level. People have told me several stories of kids literally left alone in an apartment after the parent was arrested. There has been national and statewide research looking to see if police have protocols or policies about what to do and the great majority don't.
It comes down to common sense. Many police do exercise common sense and wouldn't leave kids alone. But it's hit and miss. Some departments think twice about breaking doors. They think twice. If you handcuff someone, can you do it outside? Do you have to draw weapons? Lots of kids face weapons during arrests and experience trauma. Police always put safety first but police who have really thought about this understand that not making yourself into an enemy is a means of ensuring safety.
You also call for sentences that encourage accountability to children. Can you expand on that? Are there examples of courts and judges taking these steps?
This is kind of the great irony of indiscriminate use of incarceration. You hear accountability given as the reason. But being locked up and forced to sit idle doesn't allow you to do anything for your victim or kids.
Because very many of their parents have drug problems, the kids I interviewed helped keep me real. Five years ago I would have said using drugs is victimless crime. But the kids let me know the degree to which they were harmed by it. I would have said five years ago it was nobody's business. I don't feel that anymore.
Take Drug Treatment Alternative-to-Prison (DTAP) program in New York, for example. It's a diversion program, a deferred sentencing program, for "predicate felons," people with multiple serious priors and a drug problem who would otherwise be serving long sentences. They sentence them but defer it and send them to drug rehabilitation and job training. Part of that involves family visits and counseling and requires people to get better, to learn a trade and come to terms with the damage done in families.
Prisoners and their families are currently forced to subsidize the state and private industry through exorbitant collect call rates. You suggest inmates be given the ability to buy market-rate phone cards and that collect calls should be billed at standard rates. Are you optimistic that phone companies will ever make those changes? Are there any laws or activist movements that have gained ground on this issue?
By phone tax I am referring to the fact that phone companies get exclusive deals and charge twenty times the regular rates. Some of that money goes to prisoner welfare funds or, in some cases, general funds. You would have to take it on at the state level because I don't think phone companies could unilaterally lower rates since they bid for the contract. But for example in the federal system, or in Oregon, which is a family conscious state, someone in prison can take earnings, buy a phone card and call their family. The women I talked to said that means so much.
Like a lot of the problems with the system, it would not take rocket science to fix them. It would be easy if people were committed to it. And it would mean a world of difference for these children and these families.
A remorseless rapist in Hamilton County, Ohio is sentenced to 15 years in prison for beating and raping a 57-year-old woman. An environmental activist in California is sentenced to 22 years and 8 months for burning three SUVS at a car dealership after taking precautions to harm no lives.
The disparity helps illustrates what animal rights and environmental groups say is an expanding Orwellian attack on American environmentalism being waged under the pretext of eco-terrorism.
In recent months, conservative lawmakers, right-wing advocacy groups and law enforcement officials have ramped up efforts to dismantle eco-terrorist groups and their supports. But critics say vague wording in the USA Patriot Act, new eco-terrorist bills and aggressive law enforcement tactics are ways of quashing civil dissent and tainting law-abiding organizations.
The Federal Bureau of Investigation is at the forefront of this movement. On June 21, FBI Deputy Assistant Director for Counterterrorism John Lewis said eco-terrorists are one of the top domestic terrorist threats in the U.S., having chalked up some 1,200 acts of eco-terrorism since 1990 totaling $110 million in property damage. Eco-terrorist groups have caused no deaths.
As the FBI works to shut down elusive and decentralized eco-terrorist networks, civil rights groups say agents are going so far as illegally spying on activists. In June, a federal disclosure lawsuit by the American Civil Liberties Union forced the FBI to admit having collected 2,400 pages of files on Greenpeace, the most vocal critic of the Bush administration's environmental record, in addition to other groups.
In the courts, prosecutors work to convict activists charged with property crimes under vague and harshly punitive domestic terrorism laws. One activist, Tre Arrow, is facing life in prison for allegedly burning three logging and cement trucks in an Oregon forest. Assistant U.S. Attorney Stephen Peifer, in an interview in June, said Arrow's alleged actions are considered domestic terrorism because "it is a systematic attempt to use the threat of violence to instill fear for political or social purposes."
"Animal liberation movements are being demonized not just as whacko or extremist, but also as terrorist," says Steven Best, an animal rights activist and philosophy professor at the University of Texas at El Paso. "A collective insanity is sweeping the nation [and is] no less absurd, outrageous, frightening and irrational than the Red Scare of the 1950s. The USA Patriot Act expands government's law enforcement powers nationwide as it minimizes meaningful review and oversight by an independent judicial body."
Even though existing laws covering crimes such as arson, theft and trespassing are used to charge eco-terrorists, conservative lawmakers in several states are proposing laws that define eco-terrorism as a distinct offense -- something federal law does not do -- and deepen penalties for environmentally motivated crimes.
These states are each taking different approaches. Since 2001, 14 states have introduced laws directly addressing eco-terrorism, according to an association that tracks state legislation. California was the first state to pass such a law in 2003, and a New York law outlaws, for example, clandestine taping of animal facilities, a key tool for animal rights groups. One Ohio lawmaker wants to prosecute eco-terrorists under racketeering laws to let the state seize assets of convicted activists and sue those who are acquitted.
"I believe legislative efforts that brand activists as 'terrorists' are largely aimed at intimidating compassionate Americans from speaking out against institutionalized animal cruelty, such as the abuse and exploitation of animal by the multi-billion dollar meat, dairy and egg industries," said Nathan Runkle, executive director of Mercy For Animals, an Ohio-based animal advocacy organization.
Larry Frankel, legislative director of the American Civil Liberties Union of Pennsylvania, described a current bill in his state that ramps up penalties for criminal acts committed with a purpose involving animals or natural resources. Frankel says the measure restricts freedom of speech by boosting penalties for people who hold particular views.
At a June hearing, he told a Senate committee that under such a law "people who protest outside of an animal research facility and block the entrance to that facility may be considered eco-terrorists. On the other hand, people who protest outside of a weapons-manufacturing plant and block the entrance to that facility will not be subject to enhanced penalties even though they are engaged in essentially similar activities."
Washington State Sen. Val Stevens, a Republican, has sponsored eco-terrorism bills in the past and plans to do so again. She believes existing laws aren't enough to meet a rising threat in her state. She also said that targeting certain activities based on motive is reasonable. "Right now we use racketeering laws to prosecute people who harass abortion clinics," she said. "Why can't we do the same for eco-terrorists?"
Michael Markarian, a vice president at the Humane Society of the United States, says two conservative groups are behind the national push for eco-terrorism legislation.
The American Legislative Exchange Council, an association of conservative lawmakers, has developed model eco-terror legislation and argues that more laws are needed because the federal law used to convict eco-terrorists is too narrow. Likewise, the FBI has also asked Congress to revise federal statues to address criminal activity related to eco-terrorism, according to March congressional testimony by John Lewis, the agency's deputy assistant director.
The Center for Consumer Freedom, a corporate-sponsored right-wing group, is working to link mainstream environmental groups with underground extremists.
David Martosko, a CCF official, told the House Ways and Means Committee in March that the People for the Ethical Treatment of Animals (PETA), the United States Human Society (USHS), and the Rainforest Action Network (RAN) have, to varying degrees, supported known eco-terrorists.
"I urge this committee to fully investigate the connections between individuals who commit crimes in the name of the ALF [Animal Liberation Front], ELF [Earth Liberation Front], or similar phantom groups, and the above-ground individuals and organizations that give them aid and comfort," Martosko testified. "I would also urge members of this Committee to prevail upon their colleagues to re-examine the tax-exempt status of groups that have helped to fund, directly or indirectly, these domestic terrorists."
The committee, chaired by California Republican Rep. Bill Thomas, was already investigating RAN for possible violations of its tax exempt status last year, a move RAN officials say is an effort by conservative politicians to stifle radical critics. Labeling legitimate acts of protest as "eco-terror" is made possible through fuzzy definitions in the USA Patriot Act, said UTEP professor Best.
"The Patriot Act creates the new legal category of 'domestic terrorist' and defines it in a chillingly broad manner," he wrote in an email. "According to the law, the crime of domestic terrorism is committed when a person engages in activity 'that involves acts dangerous to human life that violate the laws of the U.S. and appear to be intended to intimidate or coerce a civilian population or to influence the policy of government by intimidation or coercion.' Clearly 'intimidation' and 'coercion' could mean anything, and the government does not adequately distinguish between violent and nonviolent methods of persuasion."
Best, who has also been a target of CCF's allegations, says the act's vague definitions are a direct challenge to liberation groups like the ALF and ELF, which represent a top domestic terrorist threat for law enforcement. "Indeed, nearly any protest group can fit the definition of terrorists, for what is it to 'intimidate' or 'coerce' a 'civilian population' or 'to influence the policy of the government by intimidation or coercion'? Protests often are intimidating, and their entire point is to 'influence' policy."
When a traffic altercation became a fistfight, Joseph Hayden laid a guy out for good and did thirteen years for manslaughter. Two college degrees later, the New York-based activist is now the public face of a movement to reclaim what prison stole from him and 4.7 million Americans just like him: the right to vote.
Thanks to a patchwork of state disfranchisement laws, nearly five million American inmates and parolees, mostly black and Latino, have no voting rights, according to Right to Vote, a national advocacy group. Currently four states (VA, FL, KY and MS) have permanent disfranchisement, two states (ME and VT) have no disfranchisement and most state policies fall somewhere in between, according to the American Civil Liberties Union.
Felon disfranchisement, seen by critics as an extension of historically biased voting restrictions, has languished below public radar for years. But activists say razor-thin election margins, lawsuits and media coverage are changing that.
"I've been raising this issue since the early 1990s but people only started pay attention after the election of 2000," Hayden, director of the New York-based advocacy group Unlock the Block, said in a telephone interview. "It became an issue after people became aware that 800,000 citizens in Florida couldn't vote. And now there's not a major university in the country that doesn't have someone doing some research on the issue."
Organized campaigns to overturn bans are underway in 10 states, and some level of activity is taking place in several others. This year alone three states have loosened or eviscerated bans, and a handful of lawsuits challenging the practice are inching their way through courts.
On Independence Day, Iowa's Democratic Governor Tom Vilsack ignited a political controversy by eliminating his state's permanent disfranchisement policy and ordering automatic restoration as soon as a prison sentence is completed. State Republicans are reportedly mounting legal attacks.
In Nebraska, lawmakers overturned a permanent disfranchisement policy and substituted a two-year waiting period after a sentence is complete. Rhode Island activists successfully lobbied for the question to go on its 2006 ballot. If passed, parolees and probationers will be able to vote once they leave prison rather than waiting for the completion of their sentence. And in Florida, the state with the highest level of disfranchisement, bi-partisan political pressure is mounting for reform, say observers.
Advocates are pushing through the courts as well, and eyes are on a handful of pending cases. The heart of the issue is whether the Voting Rights Act of 1965 was meant to cover felon disfranchisement laws, and courts appear deeply split.
Hayden vs. Pataki, a class action suit filed by Hayden and supported in part by the NAACP, is being considered by the Second Circuit Court of Appeals. In the coming months, that court could decide whether the Voting Rights Act applies to New York's felony disfranchisement statute. If so, the case goes back to trail and "the big fight begins," Hayden said.
In another case, Farrakhan v. State of Washington, judges from the Ninth Circuit Court of Appeals have ruled that The Voting Rights Act did apply to felon disfranchisement laws. To win, however, plaintiffs must show that the impact on minorities resulted from the discriminatory operation of the criminal justice system (that minorities, for example, are arrested and prosecuted more often than whites). According to Right To Vote, 1.8 million African-Americans, or one in 13, are disfranchised.
Perhaps the most closely watched case is Johnson v. Bush, a challenge to Florida's disfranchisement policies filed in 2000 and recently rejected by the 11the Circuit Court of Appeals. Plaintiffs are asking the Supreme Court to hear Johnson. But Laleh Ispahani, voting rights fellow at the ACLU, says even if the court takes the case, it would likely support the lower court's rejection, especially since Justice Sandra Day O'Conner is being replaced.
But by simply agreeing to consider the case, the Court could give juice to activists.
"If the Supreme Court does take the Johnson case ... grassroots campaigns may actually be emboldened in their pursuit of other, state-specific strategies," Ispahani wrote in an email. "These successes could mount and lead to a shift in public opinion on the issue and ultimately result in a favorable Supreme Court decision, as happened with sodomy case law."
Jeff Manza, a sociology professor at Northwestern University who has studied the issue, says he is skeptical that current federal court cases will do more than prime public opinion.
Manza also noted that Republicans have the most to lose by adding millions of Democrat-leaning ex-cons to the voter base. "Republicans are particularly worried about Florida, a state with six million ballots, where [changing the policy] would restore voting rights to 1 million people, 800,000 ex-felons and 300,000 current felons."
So it's not surprising that Red politicians will work to keep the Blue Block well-locked.
To most folks, the decades-old controversy over fluoride belongs to the realm of foil hats and ham radios, of black U.N. helicopters and Freemason conspiracy theories.
But the investigation of a Harvard University professor accused of playing down links between fluoride and bone cancer may signal a mainstreaming of the debate.
Millions of Americans consume fluoride through community drinking water. Mainstream medical groups like the American Dental Association and the Centers for Disease Control have staked their reputation on fluoride, having long praised fluoridation schemes as beneficial for healthy teeth.
But anti-fluoride activists say a growing body of peer-reviewed scientific evidence counters long-held assumptions about fluoride's safety, and they're turning up the heat.
Last month, the Environmental Working Group, a respected Washington-based watchdog organization, called public attention to a Harvard study that shows links between fluoride and bone cancer in young boys. That study, conducted in 2001 by Elise Bassin, a Harvard doctoral student, stated that "among males, exposure to fluoride at or above the target level was associated with an increased risk of developing [the rare form of bone cancer] osteosarcoma. The association was most apparent between ages 5-10, with a peak at 6 to 8 years of age."
The EWG, which claims Bassin's study is the most comprehensive of its kind to date, also formally accused Chester Douglass, a researcher at Harvard's dental school and Bassin's former supervisor, of playing down her results in a 2004 report to federal officials.
The EWG has asked the National Institutes of Environmental Health Sciences (NIEHS) to investigate Douglass and has called on federal officials to list fluoride as a potential carcinogen.
Douglass, who is the editor of an academic publication funded by the toothpaste industry, told officials that his $1.3 million federally funded study, which included Bassin's work, showed no significant link between fluoridated water and osteosarcoma.
Both Harvard and the NIEHS are investigating EWG's claims.
"The main point is that [Bassin's work] is the most robust epidemiological study to date on bone cancer and fluoride," said Tim Kropp, a senior scientist at EWG, adding that Bassin's methods were so rigorous and difficult that the methodology itself was published separately from the findings. In a letter to the NIEHS, his group claimed that by glossing over Bassin's research, Douglass violated federal laws against falsifying scientific data.
"The Harvard School of Dental Medicine takes all allegations of misconduct seriously and has a standard system for reviewing allegations of research impropriety," a Harvard spokesperson said in an email. "The School will also work in concert with the National Institute of Environmental Health Sciences in its review of the reporting of this research."
Though generations of dental students have been sold on the dental benefits of fluoride, studies over the last decade in particular have suggested a correlation with cancer. Studies conducted by the National Toxicology Program and the New Jersey Department of Health, have shown higher than normal incidents of cancer in male rats exposed to fluoridated water, for example.
Such studies have helped spawn grassroots opposition to fluoridation, and, since 1999, 70 U.S. communities have rejected fluoridation schemes, according to Fluoride Action Network, a watchdog group.
But fluoridation programs flourished even in the face of questions about health impacts. Kropp says the thrust behind fluoridation "is faceless. Some of the big proponents of fluoridation and some of the original experiments done, and done in faulty ways, aren't around anymore. But you have new generations of dentists and public health officials who were taught in school that this is fine, so there's no reason to go to the literature. It just gets passed down that way."
Nonetheless, more and more scientists are refusing to take fluoride's safety for granted.
Dr. Hardy Limeback, a leading Canadian expert and head of preventive dentistry at the University of Toronto, said he could not comment for this story because he is involved in a two-year review of fluoride for the National Academy of Sciences.
But Limeback, who once supported but now opposes fluoridation, has written extensively on fluoride's health risks, and his views are shared by many in the scientific community. He has written that global cavity rates have declined mostly as a result of fluoridated toothpaste and that topical applications rather than widespread applications through community water can prevent tooth decay. Limeback and others also point out that industrial sources of fluoride contain harmful chemicals and have not been tested properly.
"Hydrofluorosilicic acid is recovered from the smokestack scrubbers during the production of phosphate fertilizer and sold to most of the major cities in North America, which use this industrial grade source of fluoride to fluoridate drinking water, rather than the more expensive pharmaceutical grade sodium fluoride salt," he wrote in a public letter in April 2000. "Fluorosilicates have never been tested for safety in humans. Furthermore, these industrial-grade chemicals are contaminated with trace amounts of heavy metals such as lead, arsenic and radium that accumulate in humans."
Whether Limeback's views will influence the NAS's study remains to be seen. But the debate, for now at least, seems to be getting mainstream credentials.
For Luis Lopez, a 42-year-old single dad in Guatemala, globalization has nada to do with economics or democracy. On the contrary, for Lopez, it's about something much more basic: los anti-marcas (against brands), los genericos -- the cheap, generic medications that poor AIDS patients like him need to stay alive.
More than 78,000 Guatemalans are currently living with HIV/AIDS , according to Doctors Without Borders (also called Medecins Sans Frontieres, or MSF). Approximately 13,500 of them are in urgent need of antiretroviral (ARV) treatment; only 3,600 were receiving it as of December 2004. If, in coming weeks, Congress ratifies the bill President Bush signed last year -- the Dominican Republic-Central American Free Trade Agreement (DR-CAFTA) -- many of these patients could wind up literally dying for cheap drugs.
According to groups such as Oxfam and MSF, CAFTA's intellectual property protections will give monopoly-like status to high-priced, brand-name drugs in poor markets; potentially killing off generics in El Salvador, Nicaragua, Guatemala, Costa Rica, Honduras and the Dominican Republic, and preventing millions of AIDS patients from being able to afford the meds they need.
"People here are very worried about laws that will amplify patents and the testing time for drugs," Lopez said via telephone from Guatemala City.
Here's a look at some public health ramifications of CAFTA's intellectual property provisions -- a rarely acknowledged set of dangers that illustrates how pharma-friendly U.S. trade negotiators use back-door legalisms to stamp out generic medications.
Umm, That's My Data
To understand CAFTA's most controversial aspect, consider "data exclusivity." As it stands, the World Trade Organization's TRIPS agreement (Trade Related Aspects of Intellectual Property), gives poor countries the right to break drug patents in health emergencies. The U.S. signed on to that deal, as well as a subsequent agreement called the Doha Declaration, which further clarified the public health aspects of intellectual property and reaffirmed poor countries' rights to essential medicines.
But critics claim that CAFTA, through the "data exclusivity" provision, dilutes those rights by erecting barriers around pharmaceutical test data to delay the registration of generic drugs in poor markets.
To encourage the use of generic medicines, U.S. law states that generic drug-makers need not conduct their own trials; instead, they can rely on safety and efficacy data gathered by brand-name companies and placed on file with the FDA. To compensate the brand-names for their costly work, Congress restricted generic manufacturers' access to that key data -- they won't be able to use it for the next five years. CAFTA takes that even further, extending the prohibition window to "at least five years" of exclusivity for the brand-name companies. This detail could translate to long delays in bringing life-saving generics to the market.
There's more: public health experts worry that data exclusivity could ban generics from poor markets where even the brand-name originator drugs aren't sold -- shutting down all drug access until the prohibition window runs out.
CAFTA does agree to let generic companies conduct their own test data in order to enter a market. But this position could stink of hypocrisy. Multinational drug companies -- which justify high drug prices by citing massive R&D cost for new drugs -- know that generic companies in poor countries likely can't afford such costly trials. Plus, it would be an ethical breach to subject patients in Costa Rica or Guatemala to drug studies that have already been conducted elsewhere in the world.
Without the power to compulsory license the test data (just as they can compulsory license brand-name drugs through TRIPS), poor nations have their hands tied through an indirect but restrictive patent law nuance.
NDRAs: Enforce It For Us
Health experts also claim that CAFTA transfers abusive powers to national drug regulatory agencies (or NDRAs) in signatory countries. In the U.S., a brand-name drug company can stop a generic from being produced if the generic will infringe on an existing patent. CAFTA tweaks that burden of proof; local NDRAs in countries like Guatemala are prohibited from approving a patent unless the agency first proves that no other patent is being infringed upon.
The upshot is that the provision will essentially ban generics whenever a patent is in force. And by passing the responsibility of patent enforcement on to NDRAs (which know nothing about such a job) in countries like Guatemala or Costa Rica, the process is kept in bureaucratic darkness, as opposed to a drug company suing for patent infringement through the courts.
This provision, known as "linkage" (drug registration linked to patent protection processes), "essentially makes drug regulation agencies become a mechanism for private interests of patent holders," says Brook Baker, a law professor at Northeastern University. In other words, drug companies won't have to take patent complaints to court themselves, but, under CAFTA, can sit back and let drug agencies in countries like Costa Rica or Guatemala do it for them.
Bush's Political Baby
Another way CAFTA helps Big Pharma is by mandating two types of patent extensions based on delays in the patent examination and drug approval processes. In short, helping stretch out standard 20-year patent terms embedded in TRIPS.
As if that weren't enough, some Congressional critics recently argued against CAFTA's IP provisions on domestic grounds. According to a recent letter by three U.S. representatives, CAFTA could mean higher drug prices in the U.S. when Washington eventually harmonizes CAFTA's heightened patent protections with domestic law.
And what about the Bush administration, which has made CAFTA its current political baby?
The Office of the U.S. Trade Representative did not respond to interview requests. But officials spin CAFTA critics as nearsighted protectionists. Speaking at the Heritage Foundation on May 16, U.S. Deputy Secretary of State Robert Zoellick toed the administration's parroted line that CAFTA will spur economic growth and strengthen democratic reforms throughout the Central America. "Improved protection for intellectual property will encourage new creative industries and access to life-saving medicines, as we have already seen in other FTA partners, from Jordan to Singapore," Zoellick said.
But recent events in Guatemala -- the country that has already taken a first step toward implementing CAFTA -- seem to prove differently.
In two Guatemala City hospitals, and health centers in Coatepeque and Puerto Barrios, MSF administers antiretroviral medicines to 1,100 patients. Because these meds haven't been patented there, MSF is able to treat more patients -- it dispenses drugs that are 75-99 percent cheaper than the brand-name drugs bought by the Guatemalan government. Example: MSF pays $216 per person per year for the generic version of AZT+3TC, a part of triple combination ARV therapy. Guatemala's social security system, which buys brand-name, shells out $4,818 per person per year for the same combination.
In March came a frightening bellwether of CAFTA's trends.
The Guatemalan Congress, under U.S. pressure, passed a hugely controversial law that paved the way for CAFTA, in part by offering a "data exclusivity" provision. With the help of a civil group known as Grupo Solidaridad Positiva, Luis Lopez and his fellow AIDS sufferers helped organize massive demonstrations. But it may be too late to stop the law and its impact.
"If current data exclusivity provisions [in the new Guatemalan law] had been in effect prior to 2001, generic ARVs would not have been marketed in Guatemala and MSF would not have been able to access generics," according to MSF testimony. "This would have limited our ability to expand access to treatment and demonstrate the feasibility of delivering ARV treatment. In order for the Guatemalan government to expand access to ARV treatment for all those in need, it will need to retain the right to procure affordable generic AIDS medicines."
If CAFTA passes, the ramifications will obviously extend beyond Guatemala. In Costa Rica, the deal's constrictions on generic production will cause government spending on pharmaceuticals to go from 8 to 45 percent of the national health budget. Citing a study by the Costa Rican drug industry, the watchdog group Public Citizen claims that CAFTA could cause drug prices to shoot up 800 percent across the board. And the Congressional letter referenced above notes that Costa Rica faces AIDS drug costs so steep that if it is forced to forego generic drugs, available funds will cover only 18 percent of the AIDS patients who are being treated today.
Private Industry vs. Public Health
While politicians spin their versions of CAFTA's merits, pain runs deep for people working on the ground.
"We are disgusted [that the] government finds it more important to protect the commercial interests of private industry rather than public health," said Rachel Cohen, advocacy liaison for MSF's Access to Essential Medicines Campaign. "It is unacceptable that health is so subordinate to trade and economic industry. We are fighting for lives of patients, and we do not accept that health is traded away like any other commodity."
The Pharmaceutical Research and Manufacturers Association, the drug industry's 800-pound lobbying gorilla, declined to be interviewed for this story. But brand-name drug companies often note that poor markets already get deep discounts. Furthermore, certain high prices are necessary -- even in poor markets -- to pay for the massively expensive production of AIDS drugs. But public health experts point out that many brand-name AIDS drugs already on the market either aren't available or aren't sold for profit in the developing world. What's more, better manufacturing and economies of scale make it possible for companies to produce extra quantities of expensive medications at low costs.
The struggle to balance IP protections with public health was summed up last year in testimony before the International Trade Commission (ITC). Joy Spenser of the Consumer Project on Technology, a respected think tank, asked members of the commission to watch a video entitled Dying for Drugs. The video, she said, depicts the sufferings of a child dying of AIDS whose parents could not afford fluconazole -- a Pfizer product that costs pennies to make but is priced at $27 per pill in Honduras.
"Watch this film with your children," Spenser said, "and then explain why the U.S. needs the IP provisions on medicines in the CAFTA."
Clamoring for attention from a world distracted by war and terrorism, Latin Americans were hoping for a pope from their region where, by some accounts, 65 percent of the world's Catholics live.
It is also where anti-choice laws cause millions of unsafe, illegal abortions each year and where a popular repudiation of the church's stance on abortion and birth control is taking place.
That may spell headaches for the Vatican as Latin American leaders face secular pressures to soften abortion laws. But any hopes that a new pope might have tilted the church's stance on abortion was shot down with the election Tuesday of ultraconservative German Cardinal Joseph Ratzinger as Pope Benedict XVI.
Ratzinger in 2004 ordered bishops to refuse communion to politicians who support abortion rights, including presidential candidate John Kerry. In a letter that was obtained by the Italian magazine L'Espresso, Ratzinger wrote that abortion supporters "would be guilty of formal cooperation in evil, and so unworthy to present himself for holy communion."
If recent past is prologue, the new pope's unyielding stance is likely to set him at odds against Latin American politicians.
In Argentina, for example, Bishop Antonio Baseotto suggested in March that a high Argentine government official should be subjected to the biblical punishment of being "cast into the sea" for suggesting abortion be legalized. In response, Argentina's president, Nestor Kirchner, refused to recognize the bishop, prompting the Vatican to make the odd and unexplained charge that Buenos Aires was restricting religious freedom.
The issue, while mollifed slightly in recent days, challenged relations between Buenos Aires and Rome and reopened the abortion debate here, which recently has been energized by activists and organizations making public appeals for legalization. Recently, dozens of pro-choice supporters ran ads in major Argentine papers calling for legalization of abortion.
And in Brazil, the world's largest Catholic nation, President Luiz Inacio Lula da Silva has come under fire from the church for proposals to lighten restrictions on abortion.
In an interview published in early April, Rio de Janeiro Cardinal Eusebio Scheid took shots at the left-leaning president, saying "a real Catholic cannot be in favor of abortion." Lula has defended his faith in media interviews while refusing to back down from his government's stances. Pope John Paul II himself fell at odds with Lula's government and many Brazilians on issues such as contraception, abortion and Marxist liberation theology.
Watching Public Opinion
What do everyday Catholics in Latin America think?
A recent survey of Catholics in three countries, Mexico, Bolivia and Colombia, shows large swaths of Latin Americans do not agree with traditional doctrine.
The survey, conducted for Catholics for a Free Choice, a Washington-based advocacy group, found that significant numbers of Catholics in Colombia, Mexico and Bolivia believe abortion should be allowed in some or all circumstances. The report found that:
- Eighty-one percent of Mexican Catholics opposed excommunicating a woman who has had an abortion (the current Catholic doctrine). While more conservative in their views, 74 percent of Bolivian Catholics and 67 percent of Colombian Catholics think a woman should be allowed to remain in the church after an abortion.
- Of Catholic populations in Mexico, Bolivia and Columbia, 60 percent of Mexicans, 56 percent of Bolivians and 49 percent of Colombians believe that abortions should be allowed in some or all circumstances.
- Sixty-two percent of Bolivian Catholics, 55 percent of Mexican Catholics, and 48 percent of Colombian Catholics believe the decision to have an abortion lies not with the church but with the couple.
Perhaps most notably, the study showed that Catholics surveyed do not depend on church opinion when voting, further highlighting the disconnect between doctrine and political reality. Only 19 percent of Mexican Catholics, for example, said their priest would sway their votes. In Colombia, only 22 percent said their religious leaders' opinion mattered to them and in Bolivia only 30 percent felt the same.
Similar trends apply to reproductive rights, according to the study. Ninety one percent of Catholics in Colombia and Mexico and 79 percent of Catholics in Bolivia believe that couples should have access to contraception, including condoms and birth control pills. Of those groups, high numbers believe public hospitals and health clinics should provide reproductive services for free: 96 percent of Mexican Catholics, 91 percent of Colombian and Bolivian Catholics.
"These studies clearly demonstrate the attitude of many Catholics regarding the church's role of reproductive rights and politics are moving to a more progressive stance, even though the Vatican refuses to accept this shift," the study states. "Throughout this report it is clear that the beliefs of Catholics in Bolivia, Colombia and Mexico, more often than not, take a different direction that those of church officials. When and if the Vatican ever decides to acknowledge this point, it will see that Catholics all over the world have already moved in this direction."
How will global Catholicism contend with what appears to be a mass repudiation of essential points of doctrine among Latin America's vast Catholic population?
While observers say more Latin American priests on the ground seem less willing to excommunicate a woman for having an abortion, social researchers like Mariana Romero of the Buenos Aires-based Center for the Study of State and Society say the church is very unlikely to change its essential doctrine, despite secular pressures and a softening of abortion laws throughout Latin America.
Echoing that point, Marcelo Sanchez Sorondo, an Argentine archbishop and the chancellor of the The Pontifical Academy of Sciences, says the church will face new realities and may shift on certain issues. But it will remain unmoved on some fronts.
"The church," he said in a recent interview published in El Clarin, a leading Argentine newspaper, "is never going to accept abortion."
Medical technologies are a main driver for escalating drug costs, helping put health coverage out of reach for millions of Americans. In a new book, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises, two medical professionals explore disturbing practices and trends that lure consumers into thinking that "new" drugs and technologies are equivalent to or better than old ones.
The authors are professors at the University of Washington. Dr. Donald Patrick is a Ph.D. researcher in Health Services who has held appointments at Yale and St. Thomas' Medical School in London and has taught at the University of North Carolina. He is a member of the Institute of Medicine. Dr. Richard Deyo received the 2004 John M. Eisenberg Award for Career Achievement in Research from the Society of General Internal Medicine and is a fellow of the American College of Physicians. Dr. Deyo recently spoke to AlterNet about regulatory failures, marketing hype and the need for patient empowerment.
Kelly Hearn: You write that some people believe medical ethics, as currently structured, makes bad public policy. The argument is that huge financial outlays go to paying for medical technologies that, say, extend a single life by a week. Instead, those funds could be better spent improving needed social services or extending health insurance coverage. If Americans are to engage in this debate, what are the major considerations that need to be addressed?
Richard Deyo: I think the most fundamental thing is perhaps the hardest psychologically for people to make. We have to acknowledge that resources available for medical care are limited. They are not infinite. The problem is that individuals, physicians and patients all behave as if resources are infinite and cost is no obstacle. You hear doctors say cost shouldn't be an object. They say, "We have to do everything that might possibly benefit the patient."
The patients feel like there is no limit because insurance picks up the tab up to a million dollars, sometimes two. Now health insurance is becoming unaffordable to many people and Medicare is in trouble financially. I argue we should be trying to get the most health care for the most people as opposed to getting every last minute of life for an individual who may have a terminal illness. But words like "rationing" are taboo. We can't talk about it. It is almost as bad as being liberal in today's political debate. The truth is, if we reflect, we acknowledge that we'll have spent hundreds of thousands for one patient to prolong a week of life in an intensive care unit as opposed to spending that on other things like prenatal care and preventive services, on things that might save more lives.
Technology, you both point out, is only good to a point, that eventually it becomes a cost without a benefit. Given the American obsession with technological advances, what can be done?
More of us in the medical world need to be more honest about the limitations of technologies we are providing and realistic about what it provides. I think in many cases medical professionals, corporations and the media portray every new medical device as a breakthrough while failing to note that if a technology has benefits it is often tiny and often at the expense of side effects, complications and cost. We simply need to be more realistic about what technology offers. In many cases, if patients understood what the device does or doesn't do, they would make the kind of decisions doctors are not willing to make. They might say, "You want to prolong my life for a day for half a million dollars, that's not worth it."
You note in the book that information technology is helping in that respect by making doctors' charts and other patient information accessible and understandable to patients.
I think we need provide patients better information about what their choices are. In many cases, doctors are guilty of presenting a treatment as the only choice. In fact, there are a range of choices with benefits and costs associated with every one. If we could convey this in a concise and easy fashion, and engage patients, it would probably improve the quality of medical decisions. One way to do that is with information technology and computers. It's not the only way, but it is a good way.
States such as California and Arizona are having problems with "boutique hospitals," those that only provide costly, profitable procedures such as cardiac or imaging technologies. What dangers does this trend present mainstream general hospitals?
Boutique hospitals skim the cream of patients, those with good insurance coverage who are able to pay for services. They provide only the most lucrative services, such as high-tech cardiology and orthopedic services. The problem is that well-insured patients are pulled away from community hospitals that offer a full range of services and those hospitals may find it harder to stay in business. Emergency room care, burn care, psychiatric care – those are less profitable services that are at risk of disappearing.
Hype surrounding new medical technologies and products feeds on the American obsession with the next best thing. Yet many people assume the FDA works to filter through hype and false promises. But you cite a report showing that roughly half the experts who serve on FDA's 18 drug advisory committees had direct conflicts of interest in drugs and issues they were evaluating. This adds to a growing public perception that our regulatory mechanisms are polluted by industry money. How serious is this problem and what can be done to addresses shortcomings?
I think this is a pretty substantial problem. Since we wrote the book, we have seen the whole story of Vioxx and the advisory panel that recommended that Vioxx be allowed to stay on the market. That is a perfect example. In that case, something like 10 members had ties to the pharmaceutical industry. Absent their votes, the decision would have gone the other way. So I think there is good evidence that these kinds of ties do influence the advice panels give, advice which is usually taken.
The FDA should be more vigilant in trying to eliminate conflicts of interest on panels. They argue that these individuals have the best knowledge of drugs, and that often is true, but it seems those who have the knowledge and connections ought to be in a purely information providing and not a voting capacity. With some effort, you could assemble panels with fewer conflicts of interest.
It seems much of the hype is wrapped up in the problem of so-called "me-too drugs." Could you explain how this problem relates to rising prices for new drugs and technologies? Would it be helpful for example to require the FDA to test new drugs against other drugs on the market rather than against placebos?
This is terribly important. The problem with me-too drugs is a big one. Me-too drugs are chemically very similar to other drugs already available, yet they are typically marketed as if they were important new breakthroughs, and typically with very high prices. We found in many cases that new, expensive me-too drugs are not necessarily better than older generic and less expensive drugs. Because new and heavily marketed drugs seem like they must be better, manufacturers can command higher prices. That is an important driver of drug costs.
The story of calcium channel blockers for treating high blood pressure is an example. There are new drugs such as nifedipine and verapamil that cost 10 times more than old-fashioned diuretic drugs used for treatment. But the new drugs were never compared with older drugs. They were compared with placebos and indeed worked better. Two years ago, when they were compared to diuretics, the diuretics were equally good at lower cholesterol levels and more effective at preventing complications at one tenth of the cost. Yet we saw a proliferation of calcium channel blockers because they were being heavily marketed. That is a perfect example of why we need head-to-head comparisons.
Many consumers would like to the see the government clamp down on much of the costly hype being generated by Big Pharma, especially in advertising. But in the 2000 election cycle, as Hope or Hype points out, the drug industry spent $177 million on campaign contributions and $65 million on issue ads. The massive profitability of the drug industry and its willingness to throw so much money at lawmakers gives many people a sense that the drug industry is beyond control. Do you agree, and if so, are there any positive signs, any hints that despite its wealth and power, the drug industry can be reined in?
I agree the drug industry has enormous power and influence in politics. In the current administration that is reflected by lobbying and campaign contributions, but also by the fact that people within the administration have come from the drug industry. For example, a former pharmaceutical leader is head of Office of Management and Budget (OMB).
Is there any hope of bringing the industry under better control? I don't imagine it will be easy but it seems there is room for tighter regulation that would have some effect. In fact, profitability has fallen somewhat in the last two years in part because of negative publicity, in part because of a drying pipeline of new drugs and the fact that companies have overspent on marketing and underspent on genuinely innovative research.
Some changes that might help would be changes in the regulatory processes in the FDA, the possibility of head-to-head comparisons and of tighter regulation of advertising, for example. Drug companies are not required to get approval for television or print ads before they are aired. As the process works now, the FDA can file a complaint about misleading ads but only after ads are already on the air and only after a legal review that takes six weeks. That is often enough time to complete an ad cycle for a new drug. And what some drug companies do is simply replace one misleading ad with another misleading ad, which takes another six weeks for a letter to be generated. The advertising should be reviewed before it is aired, not weeks after. This would be slower and more cumbersome and not palatable to companies. But it would be a simple regulatory change.
We are the only country in world, by the way, other than New Zealand, that allows direct-to-consumer advertising. New Zealand is now considering a change to its law.
Much of the hype generated by companies and the media has to do with the glut of scientific studies that are often funded by industry. Corporations and many researchers say this is an inevitable consequence of modern science, of bringing the most experienced minds to bear on a development project. Other say the problem depends on how much of a researcher's income is from industry. How important is that calculus?
That is a very important calculus. Dangers arise when an academic physician doubles, for example, his or her income by getting research funds from industry. It seems a variety of other things could be done to help prevent current abuses. I would argue industry should be paying for research demonstrating efficacy. How to keep them honest is the question. One possibility is requiring they report all the results and register every project before and after the fact. It would be harder to hide things. It would be harder to stop a study in midstream when it looked like the results were not going to be favorable. It would also be harder to publish the same studies over and over again, which sometimes happen in current practice. Another important issue is that drug companies often analyze data and write the articles. If academics are going to do the research, they should analyze and write the results. Some journal editors are trying to enforce that rule with only modest success.
Phthalates, the chemicals used in some cosmetics, may keep your nail polish hard and shiny and your tresses thick and glossy, but in animal tests they cause birth defects, disrupt hormone systems and lead to reproductive problems. Those are just a few of the reasons the European Union recently banned them. Now, despite a huge outcry from the $35 billion cosmetics industry, some California lawmakers are trying to ban phthalates in the U.S.
California Assemblywoman Judy Chu has introduced a bill that would ban the same two types of phthalates as the EU did. In part because the FDA does not conduct pre-market health testing of cosmetics ingredients (nor require cosmetics makers to do so), Chu was moved to present a similar bill last year that would have banned phthalates and other chemicals blacklisted by entities like the International Agency for Research on Cancer, the European Union and the Environmental Protection Agency.
Those efforts were defeated. But if passed this session, Chu's Phthalates Ban Bill (AB 908), would be the first ever phthalate ban in the United States.
"After three decades of extensive studies [on] carcinogens and reproductive toxins, the EU banned two phthalates and those are the two that I am proposing to ban," Chu said in a recent telephone interview. "It is outrageous that American women aren't give the same protections that European women are. How can a whole continent of women be protected yet Americans ignore this?"
Chu says she would also like to make companies list any phthalates on product labels but has set aside that politically more difficult task (the industry argues that rejigging its labeling process presents huge economic burdens and could infringe on trade secrets).
During last year's legislative session, Chu's original bill (AB 2012), would have prohibited phthalates and forced cosmetics manufacturers to disclose to state officials any hazardous chemicals on their products. That bill failed to pass the Assembly Health Committee after intense industry opposition.
"They probably spent millions lobbying against it," says Chu. "They flew people in from New York and spent days and days lobbying members." Supporters of the bill, ranging from the United Food and Commercial Workers to the Breast Cancer Fund were no match.
This time round, the cosmetics industry plans to mount the same kind of campaign.
"We intend to vigorously oppose any similar legislation this year," says Irene Malbin, a spokeswoman for the Cosmetics, Toiletry and Fragrance Association, a trade association in Washington representing 600 companies such as Revlon and Mary Kay.
The bills come amidst growing public uneasiness over cosmetics ingredients, especially after the EU ban, enacted in 2003 and implemented in September 2004, prohibited the use of chemicals, including phthalates, known or suspected of being toxins, mutagens and reproductive toxins.
Activists say the ban, the bills and the issue of phthalates all tell a tale of regulatory lapses, flawed scientific argument, and negligence from a powerful industry that, oddly enough, is the nation's primary arbiter over the safety of cosmetics ingredients. Jeanne Rizzo, director of the Breast Cancer Fund and director of the Campaign for Safe Cosmetics, hopes the European ban will help give cosmetic safety – long buried in the environmentalist's in-box – its overdue day.
"Cosmetics makers who sell their product in Europe will have to reformulate their products and we are arguing that they use those reformulations here," she said in a telephone interview from her home in California. By forcing companies to find safer chemical formulations, and by boosting consumer awareness, optimists say the ban could shift corporate behavior in American markets and stoke political will to regulate.
That could well be true, says Chu. "Last year it was difficult to get attention on this issue because nobody had heard of phthalates," Chu said, adding that Europe's momentum has helped raise awareness among lawmakers.
Already, the EU ban has pushed some companies to change their ways. Responding to the ban and activist pressure, L'Oreal and Revlon said in letters to the Campaign for Safe Cosmetics that they are in conformity with the new law. In a letter dated Dec. 21, a L'Oreal senior vice president wrote that the company's products are in compliance with the EU cosmetics directive "no matter where they are sold around the world." And a Revlon spokesperson penned a letter on Dec. 20 stating that "all products sold by Revlon are currently in full compliance" with EU directives.
Poisonous Poster Child
The story of phthalates is one of an industry on the loose, thanks to failed environmental and health legislation.
According to the Centers for Disease Control, different phthalates have different abilities to produce in animal studies effects such as testicular injury, liver injury and liver cancer, among other things. But the agency says human impacts "have not been well-studied" even though a 2002 CDC study reported that every one of 289 persons tested for a study on the plasticizer dibutyl phthalate (DBP) had the compound in their bodies.
Despite this, the FDA, by law, can do little. In the agency's own words, "a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA." Neither it nor any other government agency can require safety tests before chemicals are put in personal care products.
The Environmental Working Group, a frequently cited watchdog organization, sums up the issue:
Phthalates are recognized as toxic substances under environmental law, but companies are free to use unlimited amounts in cosmetics. An environmental release of just 10 pounds of DBP must be reported to environmental authorities under the Superfund law. The cosmetics industry, in contrast, puts hundreds of thousands of pounds of DBP into nail polish each year, with no requirements for safety testing or reporting to anyone.Foxes Guarding the Henhouse
Until states or the federal government exert more regulation, the principal arbiter of cosmetic safety will continue to be the industry itself, in the form of a panel of scientists funded by CTFA, the industry trade group. The Cosmetics Industry Review panel, or CIR, is staffed by scientists and two non-voting members, one from FDA and one from the Consumer Federation of America. The panel is paid by CTFA to pass safety verdicts on chemicals used by its corporate members.
In 2002, for the second time, the CIR ruled that diethyl (DEP), dimethyl (DMP), and dibutyl (DBP) phthalates were safe. And the level for human risk was found to be 36,000 times lower than the amount that caused no effect level in animals, says Dr. Gerald McEwen, CTFA's vice president of science.
Dr. McEwen, contacted in his office in Washington, stressed that CIR adheres to the same conflict-of-interest standards as the FDA and is staffed by only top scientists who produce peer-reviewed reports. Recent European Union regulations, he claimed, are political in nature, tacked together under public pressure without solid scientific proof. The industry's safety procedures are healthy, he says, and have worked for decades to balance protection and reasonable innovation. He also said the panel has reviewed some 1,200 ingredients used in cosmetics and determined that nine were unsafe for use and taken off the market.
The National Environmental Trust, another watchdog group, is less sanguine.
"Because the FDA does no pre-market health testing of chemical ingredients in cosmetics, for industry to claim considerable safe use over many years is to wholly neglect the fact that we have no publicly verifiable way of knowing such a claim is true," says Nick Guroff, the group's California organizer.
His sentiments are echoed in a report by the Environmental Working Group. After analyzing CIR documents, the group reported that the panel hasn't determined the amounts of DBP that are absorbed in people's bodies from cosmetics. Nor has it determined the full range of products DBP is used in. What's more, the group says only 11 percent of 10,500 personal-care product ingredients have been publicly assessed for safety.
CTFA's McEwan says cosmetic safety is proven by the rarity of hospital admissions.
"One of the indices of safety is a surveillance of emergency rooms called the Electronic Injury Surveillance," he says. "If you look at emergency room admissions, you'll find that cosmetics are less hazardous than, say, pillows and mattress."
Behind the Mask
Activists chaff at such arguments, considering them ethically-flawed extensions of the "dose makes the poison theory" that says toxic chemicals which fail to reach susceptible biological systems in sufficient numbers (in high enough doses) cause no harm. That people don't stagger into emergency rooms with acute cosmetics poisoning has nothing to do with it. The debate is about the long-term effects of a low-dosage soup of chemicals and, more broadly, lack of control over the industry.
"There is not the kind of precautionary review to determine long-term effect of low-doses from multiple exposures," says Rizzo. "We don't have exposures to one lipstick or deodorant. Every day we face multiple exposure to these things and there is not regulation that looks at that. These are known mutagens, carcinogens and known reproductive toxins, and there is no reason we should take that risk when we have data on long-term low-dose multiple exposure of these chemicals.
"Ask yourself, if these chemicals aren't dangerous, why do salon workers wear masks?"
In December 2004, Dr. Rebecca Gomperts gave a speech at a Buenos Aires cultural center. Anti-choice activists gathered to protest. They proffered pamphlets and hoisted signs. Some scuffled and threw punches. Gomperts, the Dutch physician who sails to anti-choice nations teaching women about the abortion pill, RU-486 (mifepristone) and, in rare cases, administering the drug in international waters under the pro-choice laws of her ship's Dutch flag, was labeled an "assassin" by angry protesters.
All in a day's work for Gomperts. And all controversy that she converts to activist currency.
Gomperts, the confrontational founder of Women on Waves and one of the world's most hardball activists, spoke to AlterNet recently from her group's headquarters in the Netherlands. She talked about confrontations with Portuguese warships, Polish right-wing nationalists, the growing threats to reproductive rights and the global backfires of Bush administration family planning policies. The 39-year-old doctor has joined the high-profile likes of Gloria Steinem and Planned Parenthood's Gloria Feldt in an uphill battle to secure reproductive rights in the face of theocracy and overreaching conservatism.
A conversation with Gomperts reveals a tendency for deep understatement ("Yes, some of the people in Argentina got a little excited"), and passion filtered through concise, unwavering, seemingly unemotional responses.
Her mind is a motor. Ask her to pause, and the mental clutch engages for a nanosecond, releases, wraps up unfinished points, and then takes another call, before coming back to the subject of dead mothers and daughters. Like 27-year-old Gerri Santoro, mother of two, who died in 1964 from a botched illegal abortion. She was found dead in a Connecticut motel room, naked, squatting over bloody rags, left to die by an abortionist who used borrowed medical tools and a textbook as guide. The grizzly police photo of Santoro's corpse is posted on Gomperts' website, a crude reminder of the undeniable reasoning that drives her: "Women are dying. Women are dying because of illegal abortions. And the death of these women is preventable."
Between 1950 and 1985 most developed countries liberalized their abortion laws. But at least 25 percent of the world's population still lives in countries where abortion is illegal, mostly in Latin America, Africa and Asia. The Alan Guttmacher Institute, a think tank, says 350 million couples around the world lack information about contraception and modern methods of family planning, even as some 80 million unwanted pregnancies occur around the world each year, according to Planned Parenthood.
According to the World Health Organization, unsafe abortions kill more than 78,000 women each year.
"I must be honest," Gomperts says, "I am quite concerned with developments around the world, and this is especially true in the United States. Anti-abortion stances of Bush have had a tremendous effect worldwide, especially as he exports abstinence-only sex education."
Art Before Activism
A self-described "artist in first instance," Gomperts studied art but took to medicine as a career. She eventually specialized in radiology, which didn't fulfill her. It was during a stint at a Dutch abortion clinic that she found her calling. It wasn't, she says, a political decision. She was fascinated by the work. And she wanted to save lives, make obvious differences, and later, as an activist, to bear witness. "I felt for the first time that I was really making a difference for women," she says.
The idea to deliver abortion services on the high seas came to her in 1997 and '98, while she was volunteering as a doctor on the Greenpeace ship Rainbow Warrior II.
"We had gone to Mexico and the women told me terrible stories," she recalls. "One woman had an unwanted pregnancy and was looking for someone to help her. She had been raped but couldn't denounce the rapist because she was looking to have an illegal abortion. Another girl I met, around 20, had lost her mother when she was 12 years old. The mother had been pregnant for the fifth time and died from a backstreet abortion. The 12-year-old then had to take care of her brothers and sisters together with her father.
"I saw that these women were in so much need, were so abused, so vulnerable. So my original thought was that it would be a real service ship that would serve twenty or thirty a day. Eventually, though, it became more an advocacy than service delivery. The reality is that it is hard to find funding."
In 1999, Gomperts founded Women on Waves.
The group's funds come from private donors, "smaller foundations," and contributions from the internet. Half comes from Europe, the other half from the United States. There's not enough money to buy a ship, so WOW's sailing campaigns have relied on rented ships, with small, all-women crews. Controvery has kept her from actually performing many sea-based abortions, but it's made her a media magnet, giving her a soapbox to talk about reproductive rights and fire social debate.
Making Global Waves
In 2002, Women on Waves' first campaign took them to Ireland, the European nation with the toughest abortion laws. After an invitation from two Irish pro-choice NGOs, the group sailed to promote reproductive health services and administer RU-486 pills outside Ireland's territorial waters. The group also hoped to publicize the fact that some 6,500 women from the Irish Republic travel to Britain for abortions each year.
But confusion reigned. The Dutch government suggested that administering abortions might be illegal. The two Irish NGOs were slammed with calls. They got scared.
"All the attention made our groups in Ireland get quite worried," Gomperts says. "They were overwhelmed by number of phone calls requested. It was panic, basically. I don't blame the local groups though. We leave, but they have to live there."
In 2003, the doctor set her sights on Poland, where Catholic authorities raised from a Communist vacuum outlawed abortion in 1993. Since then, WOW says between 80,000 and 200,000 women seek illegal abortion services within Poland and many are forced to travel abroad to obtain abortions (60 percent of the women in Poland live below the poverty line).
Sailing on the ship Langenort, Gomperts' group arrived to find their access to the small fishing village of Wladyslawowo blocked by angry protestors waving flags and fists and throwing paint and eggs.
"They were basically right-wing nationalists being paid by a conservative political party – the League of Polish Families (LPR)," she says.
After a two-day standoff, Polish authorities escorted the ship to a safe spot in the harbor. Eventually, Gomperts was able to sail outside Poland's territorial waters and administer abortion pills. Press attention was fixating.
"That campaign definitely had an effect," she says. "Before we arrived, a poll showed 44 percent of Poles favored legalization. Two weeks later that number had gone up to 56 percent."
Politics In Portugal
By 2004, Gomperts had a reputation – and a new target. In Portugal, performing an abortion with the consent of the woman is punishable by a three-year jail sentence, and the same sentence can befall the woman having the abortion. In 2001, 17 women were tried for having illegal abortions and a nurse who performed abortions was given a seven-and-a half-year sentence. (The WOW website says at this moment two women and one nurse are on trial in Setubal.)
Problems arose when WOW's ship, the Borndiep, tried to enter Portugal's territorial waters. Defense minister Paulo Portas (a Catholic) sent two warships to block entry. (Ironically, one of the ships was named F486 Baptista de Andrade, which Gomperts believes was no coincidence.)
The media jumped all over it. The Dutch minister of foreign affairs condemned Portas' decision, as did many Portuguese officials. Lawmakers in the European Parliament even joined in, condemning the move and calling for debate over illegal abortion.
With the physical path to Portugal blocked, Gomperts turned to the airwaves and the Internet. On the Portuguese talk show, SIC 10, she talked about misoprostol and announced that the drug's protocols could be found on WOW's website. (Misoprostol is a stomach ulcer medication, also known as Cytotec or Arthrotec, which induces abortion and can be purchased over the counter in most countries, even where abortion is illegal. Using misoprostol alone terminates a pregnancy in more than 80 percent of patients. In nations where abortion is legal, RU-486, or mifepristone, is used in combination with misoprostol, with a success rate of 95 percent.)
During and after the visit, Portuguese journalists pumped out some 700 newspaper articles and the WOW web site logged 2.5 million hits in 21 days – three quarters of them coming from Portugal and most visiting the pages containing the misoprostol protocol.
Controversy had again turned to currency, and, says Gomperts, "Legal abortion was resurrected as a political agenda."
Gag Rules and Attitudes
Women On Waves' next trip – Gomperts refuses to speculate when it might be – will be to Argentina, where economic problems have caused more women to seek illegal abortions. But legal problems could stand in the way. In June 2004, after three years of wrangling, the Dutch health ministry restricted how far WOW could travel and still remain under the regulatory status of abortion clinics (only 25 miles from a hospital in the Netherlands). Lawyers are appealing the decision.
The group also faces strategic limitations. "We can only go to countries where you have a strong pro-choice or women's movement," says Gomperts. "We build on their work. We don't go in solving problems. We go in and serve as a catalyst to public opinion. We make the problem of illegal abortions visible. You can only do that with the help of groups on the ground."
Attitudes are key.
"Many women say they are opposed to abortion but they believe that another person can't make the decision," she says. "If you ask people, 'Who should decide: women, church, government or doctors?' the majority of women say they are the only ones in the position to decide this. People have to come to terms with the fact that you cannot force women to carry an unwanted pregnancy. Women are willing to do anything to end it."
Gomperts finds the political climate in the U.S. especially troubling. She notes that President Bush's abstinence-only stance is a head-in-the-sand approach that offers nothing to the victims of rape or girls forced into marriage. Particularly troubling is that Bush has reinstated the global gag rule, which clamps off U.S. family planning assistance for any foreign NGO that provides abortions or abortion counseling, even if it does so with its own funds. The result, she says, is more unwanted pregnancies; more poor women without contraceptives; less prenatal care; fewer abortion services; and more senseless deaths.
The Bush administration has also held up $34 million in congressionally appropriated aid from the United Nations Population Fund (UNFPA), which deals in voluntary family planning assistance in 140 countries. The Alan Guttmacher Institute, quoting UN officials, says the funding clog will mean 2 million unwanted pregnancies per year, nearly 800,000 abortions, 4,700 maternal deaths and 77,000 infant and child deaths.
Gomperts finds another posture held by the United States particularly symbolic: On May 10, 2002, at the United Nations special session on children, the Bush administration stood alongside Iran and Iraq – two "axis of evil" nations – to eliminate references to "reproductive health services and education" as a right held by the world's children.
Against that backdrop, Dr. Gomperts plays hardball in the hardest of activist games. When, in 1869, Pope Pius IX decreed that conception renders a soul from the first moment, he planted a seed that grew into the "Justifiable Homicide" declaration signed by extreme anti-choice leaders in America. The "righteous violence" movement – which sanctions violence against abortion doctors – has produced the likes of Paul Hill, who was convicted of the murders of an abortion doctor and his medical assistant. In 1994 Hill said to a national television audience: "I definitely feel good about what I have done and what I am doing. I think I have acted nobly."
Head-to-head with such extremism, Gomperts plods on. Why? Because of the women, she says. The pregnant Polish teenager, the desperate women of Oman, even the worried boyfriend from Ireland. All of them frantic, all of them desperate.
"I keep going because I constantly confront enormous desperation and injustice done to women," she says. "What keeps me going are all the requests from women all over world who want to end their pregnancies for all kinds of reasons."
Another phone rings in the background. She pauses. "Can you call me back in a few minutes?" she says politely. "I need to take this."
Richard Moore's ceaseless schedule of meetings, conferences and borrowed couch space is a window into the activist fire that drives him.
From his office in New Mexico, the soft-spoken Puerto Rican American and award-winning environmental justice activist measures his words carefully when talking about the state of the Hispanic EJ movement, its health, its relationship with mainstream conservation groups and its potential to catalyze Latino political power in 21st century America.
He rewinds a decade to the seeds of the EJ movement, when minority groups first pressed predominantly white enviro groups to open their doors to diversity. Then he fields questions about a recent National Resources Defense Council report showing Latinos bear disproportionately heavy environmental costs in the United States.
Good work? Yes. Needed? Always.
But, in the end, says the founder and director of Southwest Network for Environmental and Economic Justice, the nation's largest network of Hispanic environmental justice groups, the report is more confirmation than revelation.
To the uninitiated, the report, issued in October and entitled Hidden Danger: Environmental Health Threats in the Latino Community, offers up alarming statistics:
- Of nearly 38 million Latinos in the U.S., some 26 million reside in areas that violate federal air quality standards.
- Nearly 90 percent of U.S. farm workers are Latino, and many of these laborers and their families are routinely exposed to toxic pesticides.
- Non-Hispanic white children are half as likely as Latinos to have unsafe levels of lead in their blood.
As the Bush administration stands poised to dismantle environmental protections in the coming four years, the study is fodder for a Hispanic EJ movement that many hope will jumpstart lagging Latino political involvement.
Because membership information is hard to track, it's difficult to draw a bead on exact numbers. Clark Atlanta University professor Robert Bullard, a pioneering scholar in the EJ movement, produces a directory that in 2004 counted 400 people of color groups from 45 states and Puerto Rico. A third of those are Hispanic organizations, most in the Southwest and West. Moore's group has nearly 60 affiliate member groups in the U.S. and northern Mexico, counting, he says, thousands of individual members.
From opposing toxic dump sites and zoning ordinances to protesting conditions in north Mexican maquiladores, Latinos are perfecting the art of activism. A Latina group, Esperanza Peace and Justice Center in San Antonio, Texas scuttled PGA plans to build a golf course atop a major water aquifer. A group called the Detroit Hispanic Development Corporation sided with Arab-Americans to confront a polluting auto manufacturer in Michigan. And in Florida, claiming them ecologically wrongheaded and culturally insensitive, African American and Hispanic sugar cane workers blocked measures intended to restore the Everglades.
"The Hispanic environmental justice is alive and doing very well, at least in California," says Manuel Pastor, a professor at the University of California-Santa Cruz, adding that because of its demographic profile, California is a bellwether of future national trends.
Activists like Moore and U.S. Congresswoman Hilda Solis (D-CA), widely praised for her environmental work, say the environment is an all-inclusive hot-button issue for Latinos. And, they say, the increasingly interconnected and seasoned movement is producing street level power brokers and networks that could have wider spillover effects for political power.
"The main challenge is to gain and garnish power through training and collective strategies," says Moore, who teaches community organizing, power structure analysis, fundraising and leadership development to help disenfranchised groups sit at tables of power, whatever the issue.
Few hopes are pinned on the federal government. Though the EPA has an environmental justice program, observers say the payoffs have been sparse and will dwindle further in Bush's second term.
"If we gauged the successes of the environmental justice movement only by what the EPA was doing, then it would not be good," says Rep. Solis in a telephone interview from Washington. "We are going to see things get worse under Bush, things like the dismantling of superfund sites which oftentimes are in high minority communities."
Hispanic groups often find themselves at odds with Caucasian-led mainstream green groups seen as exclusivist and, at times, patronizing. Caesar Chavez and John Muir may have sung in the same key, but they've come to symbolize vastly different choirs. Observers say class and race are constant undercurrents in well-intentioned conservation groups, and minority activists – often adopting an in-your-face and into-the-streets kind of activism – often fall at odds with the conservation brand of tax-break activism.
Public ruptures began a decade ago when poor groups called mainstream green to the carpet, says Moore.
"A coalition of indigenous leaders, mostly in South America, first challenged U.S. groups saying, 'Who gave you the authority to represent our interest in things like debt for nature swaps?'" he says.
Shortly after, a group of African Americans calling themselves the Gulf Coast Tenants Leadership Development Project asked the groups to diversify their boards and staff. It also called for grassroots leaders throughout the country to meet with leaders of the environmental movement. Hispanic activists, including groups Moore represented, followed suit, approaching mainstream groups with their own concerns.
Years later, in 2002, class and racial differences boiled over when anti-immigration activists tried to wrest control of the Sierra Club's board of directors. Though the group's members soundly rejected the slate of candidates, relations with Hispanic groups were damaged. And wounds remain.
"My problem is when these big groups come in and say we are going to do what we want but we need your face," says Rep. Solis. "That doesn't do it for it for us."
However, she praised the Sierra Club for working to expose the conservative elements.
"What we need are mainstream groups that come to us not just when there's an election or ballot initiative," says Solis. "That's insulting. We need investments in our community. We need funding, grants and long-term programs that have a bilingual and cultural component. I have yet to see one mainstream organization that is doing this."
Adrianna Quintero, an author of the NRDC report, says shifting demographics means mainstreams groups should work to include ethnic groups. She said she hopes the report will help bridge gaps.
"One hope is that reports like this can help heal wounds and bring Latinos in the mainstream environment movement," she says.
Moore, however, says that while NRDC is well-intentioned and produces quality work, there is still a class divide. "Like the other mainstream groups, the NRDC is still primarily a white organization. ... And in the end, people need to remember that we speak for ourselves and decide who our leadership is," said Moore.
Camilla Feibelman of the Sierra Club's environmental justice program ticks off a list of Hispanic outreach programs, including Spanish language reports and a nationally syndicated environmental column published in Spanish-language newspapers.
"Since the minority groups wrote letters to us we have tried to broaden our focus," she says. "We have done things slowly because we wanted to make sure our work was what the people wanted us to be doing."
A spokesperson for the World Wildlife Fund, however, says her organization does not have an environmental justice section and does not typically monitor what Hispanic grassroots groups are doing.
In many ways, Latino EJ groups, thanks to language barriers, cultural disorientation and historical experience, are running uphill. New immigrants can't vote and a large chunk of the Latino-American population is under voting age. Many immigrants, having come from nations where political systems are corrupt, are distrustful of politics in the U.S.
They also face misconceptions, mainly that poor Latinos are not concerned with more "global" conservation issues.
Not true, say experts.
"There is tremendous polling information that says Latinos tend to vote for bonds for open space, tend to be more supportive of protecting mountains and coastal areas," says Pastor. "There is a lot of sympathy and recognition that this is important common ground."
There are examples of grassroots activism being parlayed into institutionalized political responses. Pastor points out that in California, a bevy of Latino leaders are pushing through major environmental legislation. And Solis, for her part, has sponsored federal environmental legislation and is pushing the idea of creating environmental enterprise zones.
And given demographic trends, Pastor says mainstream groups should wake up.
"Some ask what the mainstream environmental movement needs to do to incorporate these folks," he says. "But at least in California, the question is how does the mainstream movement make itself relevant to the changing political calculus?"
As for Moore, the fire that drives him seems to be sparked by a deep sense of urgency.
"For our community, environmentalism deals with things like cancer clusters and lupus clusters," he says. "So for us, environmental issues are life or death matters."
If you haven't tried it yet, you've doubtless seen it on the shelves of your local natural foods store or on the drink menu of your favorite coffeehouse. For many people, a strong-tasting, South American tea-like drink called yerba mate has replaced their daily cup of joe. But along with mate's new popularity in the U.S. comes a number of snake-oily claims made by the growing number of companies that sell it.
Consumed centuries ago by Guarani Indian tribes in Paraguay (and later perfected by Spanish colonizers and Jesuit priests), yerba mate is widely considered to be a good natural stimulant that may be healthier than coffee, due to a unique combination of alkaloids and relatively small caffeine content. Critics, however, say rising U.S. sales to fad dieters and health food junkies overplay such benefits, offering consumers false science and overblown claims about the drink's chemical consistency and physiological benefits.
Jolt Without the Jitters
Controversy accompanies vendor claims that mate contains not caffeine, but a safer chemical called mateine, as its major psychoactive drug. Ma-Tea, a mate importer based in Atlanta, Ga., and Noborders.net, are two examples of companies that advertise their product with a commonly found quote attributed to Dr. Jose Martin, director of the National Institute of Technology in Paraguay: "New research and better technology have shown that while mateine has a chemical consistency similar to caffeine, the molecular binding is different."
But when contacted at his home in Asuncion, Paraguay, the now ex-director (whose name is actually Jose Martino), said there is no unique chemical structure for mateine and that yerba mate contains caffeine, just like coffee.
That's no surprise, say many experts.
"In recent U.S. campaigns, yerba mate marketers claim that yerba mate contains mateine," says Dr. Leslie Taylor, an herbalist and author of "The Healing Power of Rainforest Herbs." "The only studies reporting the presence of 'mateine' have been funded and paid for by companies selling yerba mate. Scientists can go into the laboratory to prove or disprove what they want to, or are paid to. This kind of research simply does not disprove the many years of research proving the opposite by scientists and university students that have never sold any yerba mate product and had no ulterior motives to conduct or report their research."
Renowned health expert Andrew Weil agrees. Writing on his Web site, he finds "very little scientific support for this distinction, but you will certainly see health claims to that effect on packages of yerba mate and in advertisements for it."
Though many mate fans cite the absence of coffee-like jitters, experts say the distinction could be a matter of dosage or differences in accompanying minerals or related alkaloids. Even smell, taste, circumstance and expectations can cause psychoactive effects to vary.
Taylor, who has compiled dozens of studies from universities and academic journals, said yerba mate has been assayed to only contain between .7 and 2 percent, with the average leaf yielding about 1 percent caffeine. Relatively speaking, that's much less than coffee.
"In living plants, xanthines such as caffeine are bound to sugars, phenols and tannins, and are set free or unbound during the roasting or fermenting processes used to process yerba mate leaves, coffee beans and even cacao beans," she says. "The mateine chemical 'discovered' is probably just caffeine bound to a tannin or phenol in the raw leaf."
Other seemingly exaggerated claims center on yerba mate's ability to help shed pounds. Though the leaves already appear in a number of weight loss pills, the drink itself is becoming popular as an appetite suppressant and meal substitute, thanks to lopsided media coverage and heavy marketing by vendors.
Dan Garcia, a mate distributor in Sandpoint, Idaho, says yerba mate sales in the U.S. totaled around $2.5 million last year and now account for some 5 percent of tea sales in the United States. His company, Aviva, which bought its own lab analysis of yerba that's used as a marketing tool, grew 65 percent last year. Aviva was especially boosted by a recent Woman's World magazine article that celebrated mate as "America's Weight Loss Tea." After the article was published, Garcia says, his company's online sales alone grew from $1,500 to $35,000 in one month.
But what kind of pound buster is it really?
A study published in June in the American Journal of Clinical Nutrition by researchers at the Universities of Exeter and Plymouth in the United Kingdom, says, well, not so much.
The researchers, who conducted 25 trials and reviewed data on several dietary supplements including yerba mate, concluded that "the reviewed studies provide some encouraging data but no evidence beyond a reasonable doubt that any specific dietary supplement is effective for reducing body weight."
Any stimulants, including caffeine and cocaine, suppress appetite. But experts warn about overuse, something companies aren't likely to highlight. Ma-Tea, for example, tells consumers that mate products have been used to substitute for meals. Though the company includes a sentence encouraging well-balanced diets, it goes on to say that "millions have used our products to aid in the control of their appetite or for diet purposes. ... Our product does alleviate feelings of hunger and leave one feeling revitalized. As a meal substitute, our Yerbas provide essential nutrients."
Experts like Leslie Taylor find such claims worrisome.
"My belief is that yerba mate is a good natural stimulant that contains caffeine," she says. "Personally I think it is generally better than coffee, which contains several alkaloid chemicals that mate does not, chemicals that seem to be hard on the liver and adrenals with excessive consumption. I do not think that yerba mate is any magic bullet for weight loss, nor should consumers purchase yerba mate to lose weight. I also think consumers should remember that too much of a good thing isn't necessarily a good thing."
Case in point, she says: "Heavy drinkers of mate in South America were documented with an increased risk of upper-aerodigestive tract cancers, a 1.6- to four-fold increase for heavy drinkers."
Though the FDA does not evaluate or test herbs, it does get involved if reports of consumer harm or misbranding or mislabeling occurs. In 2002, FDA officials issued a warning to Dakotah International Inc. for claiming yerba mate reduces blood pressure.
Millions of people in Argentina, Paraguay and Uruguay give mate near religious status, obsessively consuming it throughout the day and making it a hub of intimate social gatherings. It seems certain that yerba mate is getting its North American day. Less clear is whether it will land a respected place in the annals of American herbalism or pass away as another marketing stained, fly-by-night weight loss fad.
One morning in 1995, Juan Angulo showed up for work at an apple orchard in Pasco, Wash. owned by a large company called Broetje Orchards. His supervisor wasn't around, so when time came, Angulo and the rest of his crew got busy trimming apple trees.
"About a half hour later, my nose started running," he said in a recent interview. "Then I got a rash on my arms."
As Angulo worked, his head started pounding, his stomach started churning and the rash worsened. He and about 18 fellow trimmers soon went to the emergency room where they learned the cause of their sickness: exposure to azinphos-methyl, a pesticide derived from WWII nerve gas that goes by the friendlier sounding brand name, Guthion. Deadly to humans in small doses (a third of a tablespoon), Guthion, when sprayed on fruit trees, is adept at killing insects that threaten the multi-billion-dollar apple and pear industries.
Prompted by such stories, Earthjustice, the National Resources Defense Council and Farmworkers Justice Fund are suing the EPA over its decision to keep the popular pesticide on the market.
The environmental evil-o-meter has long registered the noxious coziness between federal regulators and the pesticide industry. This suit alleges the EPA gave thumbs up to Guthion based on scientific data generated by the pesticide industry without ever subjecting the data to review by independent bodies. The suit also says the EPA held certain data from public view and conducted a lopsided cost benefit analysis that was supposed to weigh Guthion's economic benefit against its risk to people like Juan.
Moreover, the EPA didn't consider safer alternatives that could do Guthion's job without it.
"This administration especially is perfectly happy to decide that using unsafe chemicals is okay," says Shelley Davis, an attorney for Farmworkers Justice Fund.
Davis, a widely respected Beltway activist who has for years tracked federal regulation of pesticides, is preparing for a key hearing on Oct 14. EPA attorneys are trying to get the suit dismissed.
"Guthion is the first time that I am aware of that the EPA used the unreviewed industry data generated by the Agricultural Re-entry Task Force (a group of pesticide manufacturers)," says Davis. "Previously, they evaluated field workers' risk using a different methodology. The old approach required each chemical manufacturer to conduct tests with its own pesticide to determine the effects. Now, the EPA has accepted the data generated by the ARTF to serve as a global substitute for all pesticides, even ones not specifically tested, and is using this generic data in its formula instead of product-specific data."
Her main gripe, however, is that no independent body reviewed the data used by the EPA. What's more, the one independent researcher Davis knows of who has seen the data thinks it is flawed. (That person, a university researcher, did not respond to an interview request for this article).
Much of the Guthion case is distilled to disagreements over the methods and data used in the EPA's mind-numbingly complicated formulas for determining the risk factors of worker exposure.
Azinphos-methyl was first registered as a pest control 35 years ago. Later the Food Quality Protection Act required the EPA to take a second look at azinphos-methyl and other so-called organophosphates (which are the most implicated class of pesticides in symptomatic illnesses). Three years ago, in 2001, EPA evidently thought the chemical was enough of an ass-kicker to outlaw 28 of its crop uses and phase out seven more. However, eight crop uses – including Guthion's primary use in apple orchards – were allowed to slide, something Bayer AG and Makhteshim-Agan Industries, the makers of Guthion, no doubt found worthy of a champagne toast.
"The new measures announced today on azinphos-methyl and phosmet will help decrease pesticide exposure and provide additional health protection for agricultural workers," Stephen L. Johnson, an EPA administrator, said at the time. "The best scientific expertise has been incorporated into these new precautions, and new health effects monitoring of agricultural workers will be required to determine if it is necessary to impose additional restrictions. Today's decision also provides time for farmers to make the transition to safer alternatives for the uses that are critical for crop production."
Guthion is the primary weapon apple growers deploy against their biggest enemy, the codling moth, a coin-sized bug that can chew through entire orchards. To fight the codling moth, Guthion is sprayed on some 73 percent of apple orchards in the country, says Nancy Foster, president of the U.S. Apple Association.
Foster says growers use Guthion because it is a highly effective "broad-spectrum" insecticide – meaning it kills more than just the codling moth. Growers sometimes use "softer" alternatives such as sprayable pheromones which can disrupt insect mating habits, but none offers the power Guthion does, so it ranks as the primary crop protection tool.
"Guthion is extremely important for growers who are committed to producing a high-quality apple that doesn't include insect damage," Foster says.
The environmentalists' latest suit challenges the EPA's decision to keep those primary uses of Guthion in play.
The suit's core claim is that EPA used a flawed risk-benefit analysis that accounted for economic benefits to crop producers but not the full harm to workers and the environment. In that analysis, the suit claims, the EPA relied on assumptions "that run counter to published articles and other data made available to EPA in public comments." The agency also used new industry data to estimate worker exposure rates allegedly without making the data and methods available to the public during the public comment period.
In the annoying vernacular of pesticide regulation, an important way of expressing the level of sketchiness workers face when dealing with a chemical is called the MOE, or margin of exposure. For the EPA, any pesticide that registers a MOE above 100 is good to go. Anything below 100 spells danger for workers like Juan Angulo.
Past EPA studies highlighted dangers and scenarios when Guthion exposure fell below 100. In 2001, for example, an EPA report sexily titled "Interim Registration Eligibility Decision for Azinphos-Methyl" showed that foods sprayed with Guthion offer no risks by the time they reach hungry consumers. For workers, the agency said, it was as different story. The EPA report reads:
"Even after factoring in exposure reductions provided by closed mixing and loading systems, closed cab application equipment, and all feasible personal protective equipment, safety margins (margins of exposure or MOEs) still fall well below the target of 100 for the majority of pesticide handler exposure scenarios considered."In the end, the EPA has essentially cut Guthion an exception to the MOE demand of 100, says Matthew Keifer, a medical doctor and researcher at the University of Washington.
The EPA stands by its decisions.
Few people realize that all pesticide decisions are made based on industry data because instead of using peer-reviewed data, EPA's pesticide program uses studies conducted by the pesticide industry. But regulators and even some heavy EPA critics say the studies are governed by precise protocols developed in a reasonably public process over a period of years.
Anne Lindsay, deputy office director for the EPA's Office of Pesticides Programs, said in the case of Guthion, the data was independently reviewed by EPA scientists, Canadian environmental authorities and state environmental regulators in California, all of whom had a part in the Guthion reassessment.
She also said she is unaware of any major deviations from past practices that occurred during the Guthion decision, though she has not fully reviewed every aspect of the case.
"The EPA doesn't use cookie cutter approaches," Lindsay said, when asked about the MOE demand of 100. "As we worked on Guthion we found the need to do what was relevant for Guthion. One hundred is a benchmark and we try to ensure that that the risks associated with a given exposure meet that 100. But that isn't what I would call a precise measurement. The decision is based in risk benefit, which is built into the law. If there is a high set of benefits that margin can be less than 100."
Lindsay stressed that in this case of Guthion, worker risks were mitigated by other demands such as biomonitoring requirements and expanding the time workers must stay out of a sprayed field.
As the case moves through federal court, toxicologists, regulators, activists and lawyers continue to fight over the mind-taxing details.
As for Juan Angulo, he doesn't work in Washington's apple orchards anymore, due to an unrelated workplace accident. But nearly a decade after his initial exposure to Guthion, he says he still suffers from headaches – as do many other of his coworkers who were exposed.
Earlier this month, the Bush administration announced a 17 percent increase in Medicare premiums, saying the hike was necessary to pay for added services and general increases in expenses. But the news rekindled criticism of the Medicare Modernization Act of 2003, a.k.a. the "Medicare prescription drug bill." That massive bill – estimated to cost the federal government $534 billion over the next 10 years – essentially means windfall profits for the pharmaceutical industry and substandard benefits for the average senior citizen. What's more, it ties up the government's hands, barring it from negotiating lower drug prices with manufacturers, the way other agencies like Medicaid and Veterans' Affairs do.
The biggest expansion of coverage since Medicare was established in 1965, the bill - signed into law by President Bush last December – was supposed to provide coverage for drugs that senior citizens consume at home (the regular Medicare program just pays for drugs given in hospitals and doctors offices). But after being chewed on by nearly 1,000 drug industry lobbyists and washed down with millions of dollars in campaign contributions, the measure stumbled embarrassingly short of its mark. It became a symbol of the grip that the pharmaceutical industry – Big Pharma – has on Washington.
In essence, passage of the law was akin to a major heist. And what taxpayers and seniors lost – and what big pharma gained – is only beginning to emerge. So is the issue of how they pulled it off. Given the differing record and positions of Bush and John Kerry, the outcome of Nov. 2 could have a significant impact on the health and pocketbooks of millions of Americans.
"The bill is tragic," says Alan Sager, a Boston University professor who has closely studied the new law with his colleague, Deborah Socolar. "While this law will help some seniors get drugs they need, my colleague and I predict drug-makers will garner $139 billion dollars in increased profits over eight years, thanks to this new benefit, as inadequate as it is to patients and as expensive as it is to the federal government."
The Congressional Budget Office projected the law will cost taxpayers $400 billion over 10 years, but after it was enacted, the Bush administration revealed that the costs could reach $534 billion (that potentially illegal withholding of data is the subject of a federal investigation).
Sager and Socolar calculated in October of 2003 that 61 percent of Medicare dollars spent to buy more medicine will become profit for drug-makers.
Bill of Goods
The impetus for the law was that it would do a ton for the people who need drugs most. Did it?
John Rother, policy director for the AARP, which supported the bill, calls the law "a first step" that benefits low-income seniors, nearly a third of whom will qualify for "very generous benefits worth $4,000 a year with no premiums or deductibles." It will also help seniors with the most expensive drug bills, he says. But for those with moderate drug needs, the benefits "will provide only modest help."
Some critics say that unbalanced coverage creates an unacceptable "donut hole." According to Public Citizen, once the law takes effect in 2006, the poorest seniors making less than $12,000 (or $16,400 if a couple) will be spared nearly all costs if their assets, not including a car and home, are less than $6,000 for a single person and $9,000 for a couple. The other two-thirds of seniors will face a $420 premium, a $250 deductible and a share of the cost of drugs that will vary according to the size of the bill. By 2006, the watchdog group says, the average senior will face $3,160 in total drug costs; under the new law, seniors will still have to cough up 66 percent of that amount.
Big Pharma came out smelling better.
For its lobbying efforts, it landed a motherlode of future customers. The Medicare Rights Center, an advocacy group, says Medicare enrolls 35 million adults aged 65 and over and six million younger persons with disabilities. The typical Medicare beneficiary has an annual income of $14,300 and at least two chronic health conditions. Extending a drug benefit to those millions means a mammoth expansion of Big Pharma's customer base.
But the industry hit the jackpot in two other ways: getting those new customers while avoiding any price controls and blocking legislative attempts to let Americans buy cheaper drugs from other countries.
The new Medicare law expressly prohibits the federal government from bargaining with drug-makers for lower drug prices, something private insurers, Veterans Affairs and Medicaid already do. In a move that essentially privatizes Medicare, lobbying force melded with free market ideology to splinter the program's bargaining power among a set of private insurers charged with carrying out the benefit.
"It is almost a laughable proposition when you have an entity like Medicare with the purchasing power of 41 million people and they cannot negotiate with industry," says Congressman Bernie Sanders, (I-VT), who voted against the bill. "That is a direct result of the pharmaceutical lobby, which in my view, is heads and shoulders above the rest in terms of power."
Critics of the law, including Democratic Presidential nominee John Kerry, say the bill also hands out $46 billion in subsidies to industry. Traditionally private health plans have stayed out of the Medicare market. To get them involved, the Medicare law offers these private industry players higher reimbursement levels than traditional fee-for-service coverage.
"Basically, in order to create incentives for private plans to participate, there were significant overpayments made to HMOs," says a former Clinton administration official who asked to remain anonymous. "By paying health plans and insurers more than they would pay traditional Medicare to offer the same benefit, they incentivized or bribed them to participate so the overall mechanics would work."
Complicating matters, say insiders, is that while money should flow to health plans, executives worry the cash won´t materialize, especially given the recent prediction by the Congressional Budget Office of a record $422 billion federal budget deficit in fiscal 2004.
Big Pharma faces big battles to help keep the effective ban on reimportation intact. Industry and other supporters of the ban claim medical safety is at stake and the Bush administration has said it will not assume responsibility for ensuring the safety of imports. One estimate cited by Public Citizen says keeping the ban in place is worth $40 billion over ten years.
"In a globalized economy, we can import every conceivable product but somehow we can't reimport drugs into America from counties like Canada where they're sold for a fraction of the cost," Rep. Sanders says. "Again, the overwhelming reason is the power of the pharmaceutical lobby."
Conversations about whether or how to rein in its wealth, power and dubious tactics cut deep into the American character. They have to do with the public role of private medicine makers, the practicality of market controls and the idea that big drug companies should face higher public standards because their wealth relies on public favors like tax breaks and federally-protected patents.
For supporters of the law, price controls run counter to American ideals of market economics.
"'Bargaining clout' actually means price controls," says Stuart Butler, an analyst for the conservative Heritage Foundation. "In all other parts of the economy and in other countries where there are such controls, quality and availability suffer. If it were not so, we should simply have the government use its 'bargaining clout' to get us a vast range of wonderful products at a cheap price, just like residents of the Soviet Union enjoyed."
Drug companies argue that price controls will cut into research and development of new medicines. But experts like Marcia Angell, former editor-in-chief of the New England Journal of Medicine, disagree. Angell claims in her new book, "The Truth About Drug Companies; How They Deceive Us and What to Do About It," that big drug companies garner most of their success not from novel new drugs but from so-called "me-too" drugs that are merely molecular variations of popularly selling drugs. What's more, she claims, advertising and marketing – including salaries and executive benefits – almost always outpace investment in research.
Cost of Doing Business
In what is probably a record, the pharmaceutical industry, HMOs and related interests spent some $141 million dollars employing 952 lobbyists to help ensure the Medicare law went its way, according to a report from Public Citizen. Working off federal disclosure forms, the group also reported that The Pharmaceutical Research & Manufacturers Association (PhRMA), which represents more than 40 big-name drug companies, alone spent more than $16 million, a 12 percent increase from the previous year. That money bought 136 lobbyists in 2003.
"Certainly this was the biggest lobbying effort in recent memory and perhaps the biggest ever unleashed," says Craig Aaron, an investigative reporter for Public Citizen.
A PhRMA spokesman, Court Rosen, says the industry doesn't discuss its advocacy tactics. But watchdog groups and Hill insiders say the tactics are costly, well-honed and still very active.
The Center for Public Integrity says industry trade groups like PhRMA and Biotechnology Industry Organization (BIO) and just the top 18 drug companies in the Fortune 1000 have spent more than $430 million employing a team of almost 1,200 lobbyists since 1998. According to one Washington Post account, since the 2000 election, the industry has contributed $60 million in political donations and spent $37.7 million in lobbying in the first six months of 2003.
For the new Medicare law at least, the investment paid big.
"While they could have been big losers," says Dean Baker, co-director for The Center for Economic and Policy Research, a Washington think-tank, the pharmaceutical industry "walked away with a massive government subsidy that will likely increase their profits by more than $100 billion over the next decade."
Kerry, Bush and Big Pharma
Politically, the new law seems to have become a sweet lemon for Bush and a whipping post for Kerry. Observers say the President has failed to reap the kudos he expected from the law, though he still pitches it as a market-oriented boon to seniors. Kerry and the Democrats say it's a flawed measure evidencing a far too cozy relationship between the Bush administration and the pharmaceutical industry. Kerry has called for allowing reimportation and letting the government negotiate over drug prices.
Lots of senior citizens are upset and both campaigns have surely taken notice. A survey released in August by the Harvard School of Public Health and the Kaiser Family Foundation showed almost half of the Medicare enrollees have an unfavorable view of the new law. A quarter had a favorable view. Nearly three in 10 said the law would have an impact on their vote in the presidential race. Of that group, 44 percent (or 12 percent of all Medicare beneficiaries) said it would make them more likely to vote for John Kerry. Eighteen percent (five percent of all beneficiaries) said it would make them more likely to vote for George Bush.
On the Hill, insiders say the Medicare law is somewhat of an orphan. Conservative Republicans are testy because the law spends money wastefully and brings them no credit. Liberals complain that the benefits are lousy. And moderates believe the money could have been spent in better ways.
As the election approaches, several bipartisan efforts are mounting in Congress to lift the reimportation ban. But Senate Majority Leader Bill Frist said this month that the Senate probably wouldn't vote on the matter before the elections. But supporters of reimportation (who've already passed legislation in the House) called on Frist to bring the matter up for vote or risk opening a scorching debate on drug prices on the eve of the election, according to a report this week in The Hill, a political newspaper in Washington. The AARP, perhaps the only political gorilla that can truly wrestle with Big Pharma, is also pushing to allow reimportation and to let the secretary of Health and Human Services negotiate with drug companies, says spokesman Rother. He says the group is also working on several "mostly technical" issues designed to contain drug prices and boost consumer protections in the program.
Against that backdrop, Big Pharma's lobbying machine keeps on ticking: So far this Congressional session, the Center for Public Integrity reported last month, 113 pharmaceutical bills have been introduced dealing with issues such as patent extensions and tax breaks for drug companies.
"The good ' fashioned process of voting out the people that depend on the industry's money," says Rep. Sanders.
Faced with exorbitant prescription drug prices and contemptible marketing tactics, the American public seems to be swinging back against major drug companies. Marcia Angell, for two decades the Editor-in-Chief of The New England Journal of Medicine, is contributing boldly to that fight with a front row expose of Big Pharma�s excesses and neglects. In a disturbing new book, Angell, now a Senior Lecturer in Social Medicine at Harvard Medical School, spotlights the dubious tactics that garnered big drug companies an estimated $400 billion in worldwide sales in 2002.
Once tapped by Time magazine as one of America�s 25 most influential people, Angell uses her penetrating new work, The Truth About the Drug Companies: How They Deceive Us and What To Do About It, to propose reforms that could bring the megacolossal industry under control. Angell�s book will be published by Random House later this month. She talked with AlterNet about the excesses of the drug companies, the failure of the government to rein them in and about what it will take to turn things around.
Drug companies claim that high drug prices are needed to offset research and development (R&D) costs. You point out that this isn't particularly true in part because of the industry's reliance on so-called "me too" drugs. Can you explain?
A "me too" drug is a drug that's a minor variation of a drug already on the market. Most of what big drug companies turn out are "me too" drugs. There are, for example, six statin drugs on the market. These are cholesterol-lowering drugs of the Lipitor type. Lipitor wasn't the first statin. The first statin to come on the market was called Mevacor. It had such a large potential market that other companies realized that rejiggering the molecule a bit would allow them to have a share of this very large market. Lipitor is now the best-selling drug in the world. But it is a "me too" drug.
Likewise, your analysis of SEC documents revealed that R&D for many companies is a rather mysterious budget category that could include what some would consider to be marketing programs. How do R&D expenditures generally rank when compared to expenditures for marketing and administration costs? And to profits?
The pharmaceutical industry talks a lot about how much R&D costs. But the R&D is consistently less than big companies make in profits and far less than what they spend on something they usually call "marketing and administration." Companies vary a little in the name for this but it's a big category that includes all kinds of promotional activities plus administrative costs like executive salaries, legal fees and so forth. This is by far the largest part of their budgets, usually somewhere from two to two-and-a-half times what they spend on R&D.
Medicare was enacted in 1965 with no provision for outpatient prescription drug benefits for seniors. You point out that drugs were cheaper, people took fewer drugs and seniors could afford to buy what they needed. Today, because many seniors don't have supplemental insurance or collective bargaining power, prices are highest for the people who most need drugs. Will the recent Medicare reforms help?
The Medicare drug benefit that was just passed in late 2003 will do very little to help senior citizens because it specifically prohibits Medicare from bargaining with drug companies for lower prices. All large private insurers already do this. So do some government programs such as the Veterans Affairs (VA) system. Medicare would be the biggest purchaser of all. It would have enormous bargaining power. The pharmaceutical industry did not want that to happen and they made sure it would be explicitly prohibited. And it was. What we are left with is a drug benefit that is inadequate to begin with. It has this huge donut hole for example. As prices increase at the rate they are now, and they'll probably increase at least that fast, [the benefit] will quickly be washed out by rising prices.
Are there other potential reforms waiting in the wings?
There are some. The most important reform in my view would be for the Food and Drug Administration (FDA) to require that new drugs be tested – not against placebos, but against older treatments already on the market for the same condition. If that were required, most new drugs, which are "me too" drugs, wouldn't be approved. That's because there's no reason to think they are better. By default, that would force the industry to put some real R&D efforts into genuinely important novel drugs. They wouldn't get away with this gigantic "me-too" industry.
That would be important but it wouldn't directly deal with costs, although I think it would have ripple effects that might. As I said, the biggest part of Big Pharma's budget is marketing and administration. They have to spend a lot to market "me too" drugs because there is no particular reason to think that one is better than the other at comparable doses. So it takes a heap of marketing to convince doctors and patients to buy one statin instead of another statin or one SSRI antidepressant instead of another. If it were a genuinely important new drug, if it were a cure for cancer, you wouldn't have to promote it incessantly. That would save a lot of money right there because marketing budgets could shrink. That would take an act of Congress and my understanding is that similar bills have been introduced to look at how new drugs compare with older ones. My proposal is a little different in that I would see it as something the FDA would require as a condition for approval. Others, I think Senator Clinton for example, have suggested the National Institutes of Health (NIH) might want to study "me too" drugs already on the market. But, to me, that's too late.
You call for breaking the dependence the medical profession has on drug companies. As a reporter, I constantly confront the trend of drug companies paying doctors to evaluate their products. Those evaluations, or at least the ones that are pleasing to industry, are then fed to us as though they were the latest, greatest scientific finding. How much does this erode public confidence and what could be done to stop it?
It ought to erode public confidence. It's not so much the fact that the drug companies are sponsoring clinical trials as it is the terms of sponsorship. Drug companies have always sponsored trials of their own drugs. But they used to give a grant to an academic medical center and the center would get a faculty investigator to do the trial. The company would stand back and wait for the results. Now they don't do that. They are intimately involved in all aspects of the trial. They design the trial. They analyze the data. They write the paper. They even decide whether the paper will be published. So now they do have real control over the evaluation of their own products. That's a terrible conflict of interest.
Also many of the researchers have other financial ties with the same companies whose drugs they are studying. They sometimes have equity interest in the company. They get consulting fees. They are on speaker's bureaus and so forth. So they are biased from the get-go. I think the public ought to be very concerned about this.
Recently we have heard calls for a registry of clinical trials. This was in the wake of reports that GlaxoSmithKline had suppressed negative information. I don't think this is unique to GlaxoSmithKline at all because, as you say, the companies are not very much interested in publicizing their negative studies. Even though they are supposed to provide the FDA with all trials when they apply for approval, they don't have to publish all of them and the FDA is prohibited from making them public. So negative trials are suppressed and I think the literature is very biased as result of that suppression.
A registry would be a very good thing to have but it has to be done the right way. It should be one central, public registry, probably administered by the NIH. All trials ought to be in that registry, not just the ones the companies find meaningful. I would make it a condition of enrolling human subjects in research. As soon as a drug company enrolls human subjects, it no longer is dealing with a purely private matter. It is using people who rightly expect they are contributing to scientific knowledge and have a right to expect that the work will be publicly accountable. The registry, then, would contain all work on human subjects from the inception of that piece of research. Before the study even begins, the design of the trial should be placed in the register. This should include the number of human subjects, whether they are old or young, the drug that will be tested, whether it will be compared to a placebo or an older drug, how long the study is going to last, what the endpoints will be, everything before the trial starts. Then when the trial is finished they would add the salient results to this registry.
It is terribly important that it be done this way. If you wait until the trial is finished, you permit companies to change the goalposts as the trial goes along. There was a widely publicized case of a one-year study of Celebrex. The company published the first six months as though it were the complete study. That's because the drug looked good in the first six months but not so good in the second six months. In the registry, they would have entered the design of the trial at inception. It would say, "This is a one-year study." Then they wouldn't be able to shift the goalposts.
Recently, big drug companies have been the target of lawsuits alleging all kinds of wrongdoing including fraud, burying research evidence, fraudulent advertising and overcharging Medicare and Medicaid. What are the most important kinds of cases, those that can make the biggest dents?
I'm not sure these cases can make any dents in the dubious practices. Even though the fines have been huge, they are nothing compared with what the dubious practices have garnered them in revenue. They are a cost of doing business. Most of the big drug companies are under investigation now for one thing or another. Some of the pharmacy benefits management companies are also under investigation. It is a constant thing, involving charges of Medicare or Medicaid fraud, of advertising for off-label uses, of giving doctors kickbacks. But I'm not sure it has any real effect.
You quote an industry spokesman saying that the pharmaceutical industry is facing "the perfect storm." Health insurers, for instance, are developing formularies. Many profitable patents are nearing their end. And consumers are buying cheaper drugs from Canada over the Internet. What is the most intractable problem for the pharmaceutical industry? Is it the fact that very few blockbuster drugs are in the development pipeline?
There are two problems. Number one, the pipeline is drying up. Big drug companies are in serious trouble. They are trolling small biotech companies all over world. They are hovering around academic medical centers hoping someone will come up with something they can license and develop. Number two, there is nobody left to pay the prices. The prices keep rising but individuals can't afford it. The federal government is running a huge deficit now, so that's not going to be much help. The states are also hurting. Medicaid is one of the biggest expenditures for state governments and a big part of that expenditure is the drug costs. So there's nobody left who can keep paying these prices.
One reform you suggest is to require pharmaceutical companies to open their books to the public. Why shouldn't the pharmaceutical industry be able to protect it's proprietary information just as other industries do?
This is a well-protected industry that depends utterly on government favors. It lives to a large extent off taxpayer-funded research done in universities and funded mainly by the NIH. It lives off government-granted monopoly rights in the form of patents and FDA-conferred exclusively. It also gets huge tax breaks, both tax deductions and tax credits. So although it talks the rhetoric of the free market, it is on welfare big time. I think this industry owes the public something for being treated so very well.
You have said that an "aroused and determined" public can provide the political power needed to counterbalance the influence of drug companies. What are examples of groups that are helping to organize public dissatisfaction?
I think the AARP is one. Their members were very unhappy when the AARP leadership supported the Medicare drug benefit without any provision for bargaining for good prices. Many members quit. The leadership has had a change of heart and now they want to see this bill changed. Senior citizens are among the most sophisticated people on this issue because they pay for drugs out of pocket. Also, state governments are getting fed up. The attorneys general are among those who are legally challenging this industry.
I think there is a general mood that holds, "They are getting away with price gouging and they shouldn't be allowed to do that anymore." But many people still respond to the blackmail that if anything is done to contain prices, it will somehow cut into R&D and innovation. That is one reason I wrote the book, to show that is not so.