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Zeranol, widely used as a growth promoter in the U.S. beef industry, is a "powerful estrogenic chemical, as demonstrated by its ability to stimulate growth and proliferation of human breast tumor cells" similar to the "known carcinogen diethylstilbestrol (DES),"
The Breast Cancer Fund, dedicated to identifying and eliminating environmental causes of breast cancer,
is a "powerful estrogenic chemical, as demonstrated by its ability to stimulate growth and proliferation of human breast tumor cells in vitro at potencies similar to those of the natural hormone estradiol and the known carcinogen diethylstilbestrol (DES)."
"may be a risk factor for breast cancer," says the College of Food Science and Nutritional Engineering at China Agricultural University in Beijing. The Breast Cancer Fund, dedicated to identifying and eliminating environmental causes of breast cancer, agrees: The drug The use of Zeranol requires "Appropriate Personal Protective Equipment" according to its instructions for usage--"laboratory coat, gloves, safety glasses and mask." Why is it routinely used in U.S. meat production and not even labeled?
Melengestrol acetate, a synthetic progestin put in feed, is 30 times as active as natural progesterone, says the European Commission (EC) and trenbolone acetate, a synthetic androgen, is several times more active than testosterone. Trenbolone acetate is administered as ear implants commonly seen at livestock operations. Operators say they--and the ears themselves--are thrown out at the slaughterhouse and don't enter the human food supply. Do they become feed for other livestock instead?
“There is an association between steroid hormones and certain cancers and an indication that meat consumption is possibly associated with increased risks of breast cancer and prostate cancer,” says the European Commission's Scientific Committee on Veterinary Measures. “The highest rates of breast cancer are observed in North America, where hormone-treated meat consumption is highest in the world,” it says, adding that the same statistics apply to prostate cancer.
In fact, Kwang Hwa, Korea, has only seven new cases of breast cancer per 100,000 people, says the EC report, whereas non-Hispanic Caucasians in Los Angeles have 103 new cases per 100,000 people. The breast cancer rate also increases among immigrant groups when they move to the U.S., says the report, suggesting causes are not genetic but environmental. In all the seeking for a "cure," are people overlooking the "cause" of a lot of possible U.S. breast cancer?
Another growth drug used in U.S. beef, pork and turkey--yes turkey--is ractopamine an asthma-like drug called a beta agonist. Like growth hormones, ractopamine lets livestock operators produce more weight more quickly from their animals. Ractopamine was integrated into the food supply under reporters' and consumers' radar more than ten years ago. It became a favorite on U.S. farms when its ability to increase muscle by “repartitioning” nutrients and slowing protein degradation was discovered in a laboratory.
Unlike other veterinary drugs used in U.S. meat that are withdrawn before slaughter (or thrown away as ears) ractopamine is begun in the days before slaughter and never withdrawn. It is given to cattle for their last 28 to 42 days, to pigs for their last 28 days, and to turkeys for their last seven to 14 days. Marketed as Paylean for pigs, as Optaflexx for cattle, and as Topmax for turkeys, ractopamine is not just banned in Europe, it is banned in 160 countries.
Public health officials and livestock specialists are increasingly questioning the drug's wide and often clandestine use. “Ractopamine usage benefits producers, but not consumers. It is bad for animal welfare and has some bad effects on humans,” said Donald Broom, a professor at the University of Cambridge’s department of veterinary medicine, at a forum on the topic in Taipei earlier this year.
In China, the Sichuan Pork Trade Chamber of Commerce reported that more than 1,700 people have been “poisoned” from eating Paylean-fed pigs since 1998 in 2007, it seized U.S. pork for its ractopamine residues.
Thanks to the effect of Big Meat's black hand on USDA and FDA policies, Americans have an almost unlimited supply of cheap meat for breakfast, lunch and dinner. Unfortunately it does a lot more for the meat industry's "health" than for food consumers'. END
Martha Rosenberg's acclaimed expose of Big Food, Born with a Junk Food Deficiency, is now available in bookstores, libraries, online and as an ebook in time for the holidays.
twitter @marthrosenberg
Many first heard of the uber sleeping pill, Ambien, in 2006 when former Rhode Island representative Patrick Kennedy drove to Capitol Hill under its influence to “vote” at 2:45 a.m., crashing his car. He had also been taking Phenergan, a gastroenteritis drug that can cause drowsiness, said published reports.
Soon Ambien-induced blackouts were so common, they captured the attention of public health agencies. The FDA issued warnings in 2007 about the potential of “complex sleep-related behaviors” with Ambien and 12 other sleeping pills that included “sleep-driving, making phone calls and preparing and eating food (while asleep).” Meanwhile, law enforcement officials reported traffic accidents increasing under Ambien's popularity with some drivers not even recognizing police officers there to arrest them. Dude! Help me get my car out of this ditch.
Then, horror stories began to circulate about blackout eating. Skinny dieters were waking up horrified amid mountains of pizza, Krispy Kreme donuts, and Häagen-Dazs cartons consumed by their evil twins when they took Ambien. Blackout eating became such a lifestyle problem--hours on the treadmill shot to hell--Sanofi-Aventis, Ambien’s manufacturer, was forced to publish full page newspaper ads telling people if they were going to take Ambien, to get in bed and stay there. No calling for pizza delivery either.
In 2009, Ambien was again in the news when Tiger Woods reportedly used it to spice up sex with his string of consorts which led to his separation from Elin Nordegren Woods.
And last summer, a generic version of Ambien was found in the bloodstream of Kerry Kennedy, daughter of Robert F. Kennedy and former wife of New York Governor Andrew Cuomo when she swerved into a tractor-trailer and kept driving. Witnesses said she was had been weaving for miles. Kennedy told police when she was stopped that she may have confused the Ambien with her daily thyroid med but at her court appearance she blamed a "partial seizure."
This week, the Mayo clinic in Rochester, Minn., is announcing it will no longer prescribe Ambien to inpatients because of its high correlation with falls. Data on more than 16,000 hospitalized patients found that the fall rate on Ambien was more than four times that of those not on the sleeping pill. Ambien was correlated with more falls than factors like age, mental impairment, delirium or insomnia, write authors in the Nov. 19 issue of the Journal of Hospital Medicine, reports Newsday.
And there are more negatives to Ambien than falls, car wrecks and sleep eating. The Primary Care Companion for CNS Disorders recently reported Ambien-associated homicides. "This Brief Report presents 2 cases in which concomitant zolpidem [Ambien] and paroxetine [Paxil] use was associated with uncharacteristic, complex acts of violence for which the individuals in question claimed total or partial amnesia. Neither individual had a history of aggressive behavior before killing his or her spouse; both most likely took more than 5 mg of zolpidem on the nights of their offenses."
Sleeping pills like Ambien, Lunesta, Sonata, and Rozerem have been a gold mine for Pharma because everyone sleeps--or watches TV when they can’t. Ads convey unrealistic expectations for fall-to-sleep time and the pills do not necessarily even work. In FDA documents, one sleeping pill, Rozerem, was no better than a placebo. Still, its sales shot up by 60 percent thanks to TV advertising, reported the New York Times.
Ads for Ambien in India, where it is sold under the name Zolfresh, actually claim the pill makes people live longer, according to published reports.
To churn the sleeping pill market, Pharma has rolled out subcategories of insomnia like chronic, acute, transient, initial, delayed-onset, middle-of-the-night, early-morning and non-restful sleep. The stimulants Pharma markets for "wakefulness" problems also sell sleep meds--and vice verse. Who can sleep after being on stimulants all day? And who feels wide awake in the morning after sleeping meds to treat the wakefulness meds? END
Read more about unscrupulous drug advertising in Martha Rosenberg's, Born with a Junk Food Deficiency, now available as a hardcover or ebook.
Twitter @marthrosenberg
It was supposed to replace the millions Wyeth lost when its hormone drugs Prempro and Premarin tanked in 2002 thanks to links to breast cancer, heart disease, blood clots and strokes. So many women quit the Wyeth menopause drugs when the risks surfaced, the company announced it would close its Rouses Point, NY plant where it manufactured them and eliminate 1,200 jobs. No wonder Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) looked like the way to retain the lucrative menopause market. It wasn't a hormone.
But the FDA had other plans. Though it approved Pristiq in 2008 for the treatment of adults with major depressive disorder, it gave no such green light to Pristiq for hot flashes associated with menopause. There were too many safety signals.
Why did two women in the study group taking Pristiq have heart attacks and three need procedures to repair clogged arteries compared with none taking placebo, asked the FDA? Why did trials disclose serious liver complications? How could Wyeth assure the long term safety of Pristiq when 604 of the 2,158 test subjects took it for only six months? Seventeen suicides were also reported in Pristiq’s post-marketing data.
This week Pfizer, who acquired Wyeth in 2009, agreed to settle a class-action lawsuit by former Wyeth shareholders claiming they were misled about Pristiq's risks, for $67.5 million. Pristiq has already cost the company severely, losing it $7.6 billion in market value when the FDA refused the menopause indication, reports Reuters.
Even before this week's settlement, Pristiq had few friends in the Pharma community. “Pristiq is not a good drug by any standard,” wrote an anonymous poster on the industry chatroom cafepharma when the FDA declined the menopause indication.
“We tried to get 100 mg approved as the standard dose. But our patients got so sick that they care less about the efficacy," wrote another poster. "They just couldn’t tolerate the drug long enough to see any improvement."
Smelling blood in the water at Wyeth’s setback other posters piled on. “No study exists showing any antidepressant including Pristiq works any better than a placebo for reducing hot flashes, which are subjective anyway and only last a few minutes long at worst,” wrote another industry insider. “That is a heavy price to pay to take a heavy duty drug 24/7 for a few minutes of daily relief that a sugar pill also provides. FDA is crazy (or bought) if they allow this unproven drug travesty on the market.”
Would women want to trade “hot flashes for decreased libido, nausea, increased blood pressure and incredible withdrawal issues” found with Pristiq asked another poster? “Women and their physicians are not as gullible as they were back in the Premarin days.”
Psychiatrist Daniel Carlat, who wrote a 2007 New York Times Magazine exposé about working as a Wyeth-paid spokesman selling Effexor to other doctors, also weighed in on Pristiq. “Every patient who takes Effexor produces Pristiq in their own body, at no additional charge,” he wrote in a blog article titled “Top 5 Reasons to Forget about Pristiq.” Pristiq is a metabolite of Wyeth's antidepressant Effexor XR which netted $3.7 billion in 2006 and was viewed as an unabashed patent extender for when Effexor XR went off patent in 2010.
The hormone drugs made by Pfizer, formerly Wyeth, proved so harmful to women, many said the "H" in HRT stood for hoax. This week's Pristiq settlement suggests there are more drugs in the hoax category. END
Martha Rosenberg's expose, Born with a Junk Food Deficiency, with 29 cartoons, is now available in bookstores, libraries and online. twitter @marthrosenberg
A day after the execution-style killing spree of Lawrence Jones at a Fresno chicken processing plant that killed two co-workers and wounded two others, headlines say the massacre is "puzzling" and "no one knows why it happened."
Jones, 42, "walked up to 32-year-old Salvador Diaz in the grinding room, put the handgun to the side of his head and pulled the trigger," reported the Associated Press. Diaz died at the scene. Jones then "put the gun up against the head of the second victim, 34-year-old Manuel Verdin" who also died.
Arnulfo Conrriguez and Fatima Lopez were also shot by the gunman but survived. Jones, of Fresno, also shot himself.
Why did a convicted felon and parolee have in his possession 24 rounds of .357-caliber ammunition, 21 rounds of .38-caliber ammunition and an expensive and rare .357 Derringer? Lawrence Jones had a long rap sheet of criminal convictions--sentenced to 13 years in prison for robbery in 1994 and three years for burglary and robbery in 1991. And why was Jones armed at work?
Jones sounds like the poster child for the NRA's twin campaigns of allowing firearms in the workplace and allowing felons to bear arms. For years the NRA has tried to convince employers that shootings like yesterday's would not happen if they let employees bring their firearms to work. Heck, they'd be prevented. The gun lobby also doesn't think being a criminal should attenuate someone's gun rights. When the Sun Sentinel reported in 2007 that 1,400 probable felons managed to get concealed weapon licenses NRA lobbyist Marion P. Hammer said, "when you begin taking away the rights of people that you don't like, that's the slippery slope."
Jones brings to mind the gunman Radcliffe Haughton who killed his wife and two others at a Wisconsin spa last month despite a judge's order for him to turn in his firearms to a county sheriff. Haughton had a history of violence against his wife and was under a restraining order but a day before the murders bought a gun from a private individual. There is no waiting period or background check in Wisconsin for handgun purchases from private individuals, a loophole the gun lobby fiercely defends.
Of course, there's another issue besides the easy availability of firearms. Jones' killing spree also focuses attention on conditions in the nation's slaughterhouses.
When New York Times reporter Charlie LeDuff went undercover at the Smithfield hog killing plant in Tar Heel, North Carolina he reported that Smithfield combed prisons for potential work release employees--and some prisoners preferred their cells to working in the plant. Don't people want to work anymore?
The Postville, Iowa-based Agriprocessors (now Agri Star) canvassed homeless shelters and bus stations to staff its kosher slaughterhouse after a massive immigration raid incarcerated most of its workforce. It also sought more undocumented workers through ads in Spanish-language newspapers and on Mexican radio stations in the Rio Grande Valley. Who can say scofflaw?
And at the giant poultry slaughterer House of Raeford, a Louisiana plant manager was shot and killed by an employee in 2004. Two years later, a North Carolina House of Raeford slaughterhouse employee was found shot to death in the mobile home he shared with three other workers--the apparent motive was theft of $60 of pain pills. (Pain meds are considered integral to slaughterhouse work.)
People don't like to think about the workforce and conditions--for both workers and animals-- in US slaughterhouses that keep their meat so cheap. It ruins the taste of Chicken McNuggets. And so, when a killing spree breaks out as it did yesterday in Fresno, it is called "puzzling." END
The story of Agriprocessors, House of Raeford and other slaughterhouses accused of worker and/or animal abuse is found in Martha Rosenberg's acclaimed Born with a Junk Food Deficiency.
That was not all the bad news that emerged about HRT. It also increased the risk of breast cancer by 26 percent, stroke by 41 percent, doubled the risk of blood clots and increased the risk of hearing loss, gall bladder disease, urinary incontinence, asthma, the need for joint replacement, melanoma, ovarian, endometrial and lung cancers and non-Hodgkin's lymphoma, according to medical journals.
Not exactly the fountain of youth it was billed as by hormone drug maker Wyeth (now Pfizer) in high-budget menopause awareness TV ads starring model Lauren Hutton.
In fact, HRT was such a scourge against women, in the first year that millions quit, 2003, the incidence of US breast cancer fell seven percent. It fell 15 percent among women whose tumors were fed by estrogen. Fourteen thousand women who were expected to get breast cancer didn't said news reports. And it wasn't just breast cancer women were spared: heart attack and ovarian cancer rates also fell when women quit HRT, said news reports.
The statistics must have been embarrassing to cancer researchers and public health officials. Not only was a major cause of breast cancer hidden in plain sight, the war on cancer should apparently have been a war on cancer-causing drugs!
It was even more embarrassing because the whole sequence happened before! In 1975, an FDA panel found a link between Premarin (a Wyeth HRT drug) and endometrial cancer and when women quit the drug by the millions--the same thing happened. "There was a sharp downward trend in the incidence of endometrial cancer that paralleled a substantial reduction in prescriptions for replacement estrogens," reported the New England Journal of Medicine (NEJM) in 1979.
Not wanting to lose its billion dollar HRT franchise, Wyeth's medical director wrote doctors in the 1970s that HRT still had "proven benefits" at the "the lowest maintenance dose" and that it was "simplistic indeed to attribute an apparent increase in the diagnosis of endometrial carcinoma solely to estrogen therapy."
Thirty years later, when cancer rates again dropped, Wyeth rolled out the "timing theory"--a campaign that said women don't need less HRT, they need more. "The benefits of HRT may outweigh the risks if treatment is given to younger women, but the risks may outweigh benefits if treatment is started at a later age," wrote a Wyeth-linked doc in a medical journal in 2004.
Despite the 29 percent increase in heart attacks correlated with HRT, clinical trials of whether HRT was "cardioprotective" (per the timing theory) were launched at major US medical centers in the mid 2000s. Seven of the study's investigators were Wyeth-linked, though the trials were said to be privately funded.
And despite the doubled risk of dementia correlated with HRT, a timing theory trial exploring if HRT is "neuroprotective" against Alzheimer’s Disease was launched, funded by the National Institute on Aging. The New York Times even got into the act, running a magazine article extolling the timing theory ("The Estrogen Dilemma") which its author now admits omitted the Wyeth/Pfizer links of five "experts" cited.
(Nor are animals spared in Pharma's government-abetted efforts to profiteer on women and menopause. Grisly primate experiments into early hormone use are conducted at Wake Forest, Mount Sinai and other medical centers.)
This week a U.S. Preventive Services Task Force reaffirmed the dangers of long-term HRT use. Neither combined estrogen and progestin (as in Wyeth's Prempro) in women without hysterectomies or estrogen alone (as in drugs like Premarin) in women with hysterectomies are safe on a long term basis, said the panel of independent experts after viewing the literature.
Within hours of the report, the hormone franchise bit back. "It is very important that patients understand what this report does not say: it does not recommend against the use of hormone therapy for the relief of menopausal symptoms," commented the HRT-friendly American Society for Reproductive Medicine. Key word "against."
As a new generation of women approach menopause, will the HRT lessons of the 1970s and 2000's be lost amid Pharma's marketing again? END
follow Martha on twitter @marthrosenberg
The complete story of marketing of HRT to women is found in "Weapons of Hormonal Therapy," a chapter in Martha Rosenberg's recent book, Born with a Junk Food Deficiency.
Chicago
Lambasting the "duopoly" and "Tweedle Dum and Tweedle Dee" tone of the Obama/Romney presidential debates, a slate of third party candidates at the Hilton Chicago on Tuesday offered voters fresh and impassioned views about the economy, war on terrorism, war on drugs and election, legislative and educational reform. Participating in the debate, moderated by broadcast icon Larry King, were Green Party nominee Jill Stein, Justice Party nominee Rocky Anderson, Constitution Party nominee Virgil Goode and Libertarian Party nominee Gary Johnson.
Even though two candidates leaned toward the left and two toward the right according to Christina Tobin of the Free and Equal Elections Foundation which sponsored the debate, all agreed the two-party contest which they say is swimming in corporate and special interest money, has stifled debate on issues of crucial importance to the public. In fact, Green Party nominee Jill Stein was arrested with another activist at the presidential town hall debate in Long Island last week for protesting the debate's lack of openness. She was handcuffed and anchored to a chair for eight hours, she recounted to the Chicago debate audience.
When asked about U.S. military policy, Stein said repeated bombings of weddings and funerals in war zones "don't win us the hearts of minds," of civilians. Stein, trained as a medical doctor, also urged the abolish of drone programs both here and abroad which drew strong audience applause.
The United States gives financial aid "to pump up foreign dictators," agreed Libertarian Party nominee Gary Johnson, touching on events since the Arab Spring. "We have not learned anything." Johnson, a favorite of the crowd, is former governor of New Mexico.
There are too many soldiers and "troopers scattered around," agreed Constitution Party nominee Virgil Goode, adding that no armed conflicts should occur that are not declared by Congress. Goode's conservative proposals of a moratorium on Green Card admissions to help U.S. job seekers and defunding Planned Parenthood did not warm the crowd. But his opposition to PACs and Super PACs accorded with the other candidates.
Raiding the U.S. treasury for "wars of aggression" is "wasteful" and "treason," charged Justice Party nominee Rocky Anderson, who also noted the urgency and peril of climate change. Anderson is the former Salt Lake City mayor.
Decriminalization of marijuana and the plight of college students, saddled with student loans but few job prospects, occupied much of the debate which was attended by an overwhelmingly youthful crowd. (Chicago's Loop is home to several universities.) College age students and other economically squeezed Americans are "indentured servants," Jill Stein observed twice. Colleges are "immune" to the market pressures that would normally bring costs down remarked Libertarian Party nominee Gary Johnson thanks to guaranteed federal loans.
All nominees agreed that term limits would solve the universal problem of politicians spending much of their first term seeking funding and courting special interests to be elected for a next term. Would elected officials vote themselves out of office, asked King rhetorically, by supporting term limits? The terms limits would have to be grandfathered in, replied the nominees.
Neither the nominees at the Chicago debate or the audience seemed in denial about the prospects of a third party candidate actually taking office. "Waste your vote on me," said Gary Johnson facetiously, noting that voting for "someone you don't believe in," is the real way to waste your vote.
For his part, Larry King reminisced about other third party candidates he has interviewed from Ross Perot to John Anderson to Ralph Nader. "You are like Don Quixotes in a way," he told the nominees, but this debate is a way to "salute you." END
Martha Rosenberg is a health journalist whose first book, Born With a Junk Food Deficiency was recently published by Prometheus Books.
Rosenberg: Your new book about alcoholism and addiction, Now What, is very different from your popular memoir Broken, published in 2006.
Moyers: This book is not profound or deep like a memoir. It is meant to be practical and get people from the problem to the solution. The book tries to break down the walls of denial that stand between the addict, the addict's family and the community. The solution is really very simple and I stress the Twelve Steps of Alcoholics Anonymous because this is how I stopped drinking and drugging, and how many millions of people like me recover.
Rosenberg: Certainly denial is the signature of addicts and often their families. But you give examples of society's denial too like a case in which a woman drove drunk on the wrong side of the highway near New York City and killed her daughter, three nieces and three men in the other vehicle. Despite national attention over the accident, you write that the question of whether she was an alcoholic and addict and needed treatment did not come up.
Moyers: Yes, there is tremendous public indifference, intolerance and misunderstanding about addiction and how alcoholism is manifested. Addiction is a chronic disease like diabetes.
Rosenberg: Yet you write that people don't usually blame someone for a chronic disease like diabetes.
Moyers: That is right. People with chronic diseases sometimes say of addicts, "I didn't choose this condition," but no one chooses to be an addict. The other way addiction behaves like other chronic diseases is--the person has to accept the condition before he or she can begin to improve or recover. The addict has to become part of the solution and admit powerlessness over the disease.
Rosenberg: Your family's attempts to help you are a subtext of Broken and in Now What you describe actually hiding in a closet when you family showed up to "rescue" you at a crack house. What advice do you now give families from what you have learned about this disease?
Moyers: The family needs to set clear boundaries, avoid issuing threats and make abstinence from drugs and alcohol a condition of shelter and any other help. They can't let the addict run all over them. Lines of communication also need to be kept open because the family is often the key for the addict to get the help he or she deserves.
Rosenberg: You also say that the family can play a role in a "facilitated bottom." Can you explain what that means?
Moyers: Almost always, the addict will only accept help when he or she hits "bottom." The ultimate bottoms are prison and death, of course, so anything short of that is a way out. For example, an addict may have to go through several treatments to emerge from denial. It takes what it takes. No one can make an addict willing but the addict his or herself.
Rosenberg: Does being the son of a famous person change the way that you carry the message?
Moyers: Because of my visibility I get hundreds and hundreds of requests for information and help. I serve as a something of a lighting rod and am able to reach a lot more people. Still the message I carry is the same simple message any addict carries.
Rosenberg: You wrote in a recent column that online meetings and social media will become more popular as younger people populate recovery groups. What other changes are you seeing?
Moyers: I think Twelve Step programs will continue to find relevance as healthcare dynamics change, because an abstinence based approach that emphasizes the whole person--mind, body and spirit--has appeal and works. Especially since access to outpatient care is increasing even as residential treatment options decrease; people will need to embrace recovery outside of a treatment setting. And since addiction is a disease of isolation, recovery meetings are our antidote.
Rosenberg: How do you personally work your program to prevent relapse? Especially since it is said that the "ism" in alcoholism stands for "incredibly short memory"?
Moyers: I read from the literature like 24 Hours a Day, One Day at a Time and Alanon books every day and attend my regular meetings like my home group on Monday nights. I stay vigilant about medication and have told my doctor and dentist about the risks with any pain pills I would have to take. And, every morning I thank my Higher Power for giving me a new day and every night for helping me get through the day without a drink or drug. END
An Insider's Guide to Addiction and Recovery
Softcover, 208 pp.
William Cope Moyers
I3982
Hazelden
2012
Martha Rosenberg is a health journalist whose first book, Born With a Junk Food Deficiency was recently published by Prometheus Books.
The year 1999 was a good one for the drug company Merck. In its 64 page annual report, it predicted that the arthritis medicine Vioxx (“Our Biggest, Fastest, and Best Launch Ever!”) would also prevent Alzheimer’s disease and colon cancer. It announced it was seeking approval to market the asthma drug Singulair to two-year-olds. And it forecast that 40 million women would take its new osteoporosis drug, Fosamax, as Merck continued to “help educate both doctors and patients” about the bone disease.
It turned out Merck spoke too soon. Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long-term users; Singulair now carries FDA warnings about "neuropsychiatric events" and Fosamax is suspected of doubling the risk of esophageal cancer, causing bone fractures instead of preventing them and causing heart problems, intractable pain and jawbone death. Oops.
There’s plenty of ka-ching in selling “strong bones” products for the same reason there was plenty of ka-ching in selling “hormone replacement” products: one-half the population is female, and no one wants to look old. Of course, “avoiding hot flashes” really means “still looking hot” in hormone marketing terminology, and “avoiding fractures” really means “still looking hot” in bone product marketing lingo. That’s why attractive women like Meredith Vieira from the Today show and former Charlie’s Angel Cheryl Ladd and actress Sally Field push bone drugs, just as model Lauren Hutton pushed hormone replacement therapy.
To cash in on Fosamax, the first in the bisphosphonate bone drug class, Merck decided to market the dangers of osteoporosis "far beyond ailing old ladies." It hired researcher Jeremy Allen to whip up fears of "osteopenia," the risk of osteoporosis, as a health epidemic to sell bone drugs and planted bone scan machines in medical offices across the country, says National Public Radio. Allen created the faux "Bone Measurement Institute" which also maneuvered Medicare reimbursement for the scans. By 1999, there were 10,000 bone scan machines in medical offices, said the Associated Press, when there had been only 750 before Fosamax.
Like its trouble-laden drug Vioxx, Merck’s Fosamax flew out of the FDA. It received only a six month review before its 1995 FDA approval. (The government also helped its promotion with the HHS secretary herself, Donna Shalala, participating in a 1998 rally kicking off free bone density screenings to be offered in 100 cities.)
But the wheels soon came flying off the bone drug. Patients experienced esophageal “irritation” and the warning to stay upright for one full hour after taking Fosamax, eating or drinking nothing was added after approval. One woman who took Fosamax but remained upright for only 30 minutes, not 60, had to be admitted to the Mayo Clinic with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine.
Next, dentists and oral surgeons discovered after simple tooth extractions and other in-office dental work, the jawbone tissue of patients on bisphosphonates would sometimes not heal but become necrotic and die--a condition called osteonecrosis of the jaw(ONJ), The necrotic condition did not take long to manifest “even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients"--wrote a dental journal but it somehow slipped through Fosamax’s two, three-year clinical trials on which its FDA approval was based. Doctors, dentists, and pharmacists were enraged at what looked like deliberate obfuscation by Merck.
And there were second, third and fourth opinions about Fosamax! According to an FDA epidemiologist writing in New England Journal of Medicine in 2009 there were 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and 27 incidences of cancer in Europe and Japan and six deaths.
Next reports in medical journals linked bisphosphonates to the risk of developing atrial fibrillation, or a chronically irregular heartbeat and to severe bone, joint or muscle pain. “In the most serious cases, the pain was so severe that patients could not continue their normal activities,” wrote the FDA in a press release. “Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.” Clearly, the FDA was trying hard to avoid the word irreversible.
Finally, in a development that suggests tremendous medical ineptitude if not duplicity, bisphosphonates were found to sometimes cause the very fractures they were supposed to prevent. The thigh bones of patients on bisphosphonates have “simply snapped while they were walking or standing,” after “weeks or months of unexplained aching,” reported the New York Times in an article called “Drugs to Build Bones May Weaken Them.”
It should be embarrassing to the medical establishment that a prominent drug company and the FDA "discovered" severe side effects after years of patient use and that bone scans are still merchandised though they are of no value to 90 percent of women, according to the New England Journal of Medicine. It should be further embarrassing that Merck was allowed to make $3 billion a year off a drug that many say would not have been approved had clinical trials lasted longer. Its patent expired in 2008.
Now Merck is about to launch a new drug for osteoporosis called odanacatib which has already intrigued the money men on Wall Street. "Odanacatib may be a viable alternative for patients who need continued therapy and who want benefits beyond what they received from bisphosphonates," a senior Merck research executive told Reuters without a hint of irony. END
Martha Rosenberg's first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, is available in bookstores, libraries and online.
Peter Breggin, M.D.
Psychiatric Drug Withdrawal
A Guide for Prescribers, Therapists,
Patients and their Families
352 pp., Softcover
ISBN-13: 9780826108432
Springer Publishing Company
Peter R. Breggin, MD, has been called "The Conscience of Psychiatry" for his efforts to reform the mental health field. A Harvard-trained psychiatrist and former full-time consultant at the National Institute of Mental Health, Dr. Breggin has also been a consultant to the Federal Aviation Agency on the adverse effects of psychiatric drugs on pilots. Dr. Breggin's private practice is in Ithaca, New York, where he treats adults, couples and families with children. He is the author of dozens of scientific articles and more than twenty books. In this interview, he discusses his most recent book, Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and Their Families.
Rosenberg: Since the debut of Prozac in the late 1980s, there have been many books about aggressive "biological psychiatry" which has lured so much of the population to take psychoactive drugs. But your new book seems to be the first to address how to get people off these drugs.
Breggin: The only other professional book I am aware of that addresses withdrawing from the drugs is Your Drug May Be Your Problem: How and Why To Stop Taking Psychiatric Medications, which I wrote with co-author David Cohen, who is a professor at Florida International University. This book, Psychiatric Drug Withdrawal, is also my first book to seek to get prescribers and other professionals to take a look at these drugs, the harm they cause and how to approach withdrawal.
Rosenberg: I would imagine that some will not appreciate the treatment model that you recommend in which the opinions of family and non-prescribing therapists are given equal weight to the prescribing psychiatrist. In a recent radio show you refer to this older, authoritarian model as prescribers being on a "medical Mount Olympus."
Breggin: The "person-centered" approach that I propose, team collaboration with a person's family, other caregivers and therapists, is the best model for drug withdrawal. The days of therapists seeing their job as ensuring medicine "compliance" and not venturing their own therapeutic opinions are ending. Most well-trained and open-minded prescribers now see the benefits in this.
Rosenberg: Your book shines a flashlight into the dark fears that families, caregivers and therapists have but don't often express that if a patient is taken off their psychiatric drugs they will kill themselves.
Breggin: Yes, people are scared. But families need to know that no psychiatric drugs are associated with reduced suicidality and many have strong warnings about causing suicidal behavior in their FDA-approved labels. There is a risk of suicide when a person is withdrawing from these drugs which I discuss in the book. Too often these mental reactions are termed a "relapse" of the condition the drugs were prescribed for--when they are actually a result of the process of going through withdrawal. This is obvious because when the withdrawing person is returned to a higher dosage level, the symptoms quickly disappear, sometimes in an hour or two. These risks are why the involvement of the family and caregivers is so important.
Rosenberg: There are several terms in your book that might be new to readers: CBI, the "chronic brain impairment" that results from years of being on psychiatric drugs, "spell-binding" in which someone does not realize their true impairment on a drug as if they are under a spell and the "non-emergency principle." The last term addresses some of the fears therapists might have when people withdraw from psychiatric drugs. Can you please explain?
Breggin: The non-emergency principle reminds therapists that your patient's emergency is not your emergency. When you react to a person's emotional crisis with alarm you escalate the situation--
Rosenberg: --like a toddler who falls but doesn't realize she is hurt until she sees her mother's face--
Breggin: Yes. If a therapist is caring and comforting, the patient does not have to end up in the ER on psychiatric drugs. When the therapist remembers the non-emergency principle and does not make the emotional crisis his or her emergency, the patient can achieve insights from the experience. But when the therapist hands the person off, he or she is reinforcing that the patient can't be dealt with without hospitalization and drugs.
Rosenberg: That makes sense but aren't there situations in which a therapist is overwhelmed, afraid or powerless?
Breggin: I have been seeing patients since 1968 and I have resorted to voluntary hospitalization on only a few occasions. In that same period of time, I have never had a completed suicide among my patients and only three patients have attempted suicide, two of them way back in 1968. I always remain accessible by phone and just knowing this also helps patients in an emotional crisis.
Rosenberg: You state in Psychiatric Drug Withdrawal that the epidemic of so called bipolar disorder and mania is largely caused by the drugs themselves. Certainly bipolar disorder, once called manic depression, used to be rare and was not the major disease that TV ads call it today.
Breggin: With very rare exceptions, all the children and teens that I have seen diagnosed with mania or bipolar disorder have either been improperly diagnosed or their disorder was caused by an antidepressant or stimulant drug. In adults I have evaluated, most mania or bipolar disorder cases have resulted from exposure to antidepressants.
Rosenberg: You give four scenarios in your book of how an inappropriately prescribed drug leads to other drugs until a person is on a cocktail of dangerous drugs for no rational reason. I think everyone has met someone who's received one psychiatric drug and then a cascade of follow-up drugs…
Breggin: The first case is the scenario in which a child is put on ADHD drugs to which sedatives are added for sleep, then antidepressants, then mood stabilizers as each drug exerts negative side effects. The second scenario is someone whose antidepressant is followed by a benzodiazepine tranquillizer, then by a mood stabilizer, then an antipsychotic--again treating each drug's side effects. In the third scenario, a person is given anxiety drugs which are followed by stimulants because of the oversedation and sleeping pills because of the overstimulation. Then, the person might be given Alzheimer drugs because of the drug-induced cognitive problems and diagnosed with bipolar disorder or "adult ADHD." Finally, there are the people who suffer psychotic breaks when they are young and are put on antipsychotic drugs, likely, for the rest of their lives to which other drugs are added to treat the side effects.
Rosenberg: Some of the drugs you write about, especially the antidepressants, are linked to suicide and even homicide in published reports. But you also write about subtler effects of these drugs in which people become so apathetic and disengaged, they are not present in their own life. A woman in the book did not cry the entire time she was on an antidepressant even though she had plenty to cry about.
Breggin: A universal symptom of brain injury whether from a football or other traumatic injury, drug and alcohol addiction or psychiatric drugs is loss of the zest for life and indifference toward people whom you previously cared about. Children on these drugs lose their spontaneity--that which makes them children--and what's called better behavior or attention is actually a version of obsessive/compulsive disorder, like fixation on the computer screen. The same thing is seen in chimpanzees given these drugs--they "behave" very nicely, not trying to interact with their neighbors and not grooming themselves. Kids are made into similarly good caged animals.
Rosenberg: It is obvious these drugs and drug cocktails are a financial phenomenon, with drug companies themselves admitting their dangers once the patent has run out. What is more shocking is why the medical establishment allows what is almost a patient heist and clearly supports it. Have you experienced a backlash from doctors or Big Pharma when going up against these drugs?
Breggin: Anything you can imagine has happened to me in the four decades I have opposed the psychiatric drug establishment. In the 1980's the National Alliance on Mental Illness, NAMI, tried to get my medical license revoked and were supported by the American Psychiatric Association. However, I had a complete victory and it led to publicizing my reform work on a new level.
Rosenberg: NAMI was investigated by Congress for undeclared Big Pharma funding. Alan Schatzberg, the former APA president, was simultaneously consultant to seven pharma companies and on Sanofi-Aventis' Speakers Bureau, according to the APA's Daily Bulletin in 2010.
Breggin: Yes, I was among the first to blow the whistle on what I call the Psychopharmaceutical Complex.
Rosenberg: It is obvious from your book that to withdraw people from these drugs requires tremendous resources which are not always available. In addition to the dedication and endurance of the patient, the family, caregivers and therapists will be involved for months and even years. It's clear that patients are given drugs they cannot easily or ever quit and are not necessarily aware of this in the beginning. Though you state these alarming facts in your book, you do not seem unusually angry.
Breggin: When I was younger, I was very angry about the legions of people abused by the psychiatric profession. But the spiritual state of anger is not where I want to be and I do not wish harm to the prescribers giving out these medications. When you look at people like Gandhi, Mandela and Martin Luther King, who are my personal heroes, they present loving models who were connected to God and not vindictive. Anger keeps us rooted in ourselves instead of thinking of others, which is what I try within my limits to do. END
Martha Rosenberg's first book, Born with a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health is now available as a hardcover and ebook and found in bookstores, libraries and online.
It would be laughable if it weren't tragic. This week Surgeon General Regina Benjamin introduced a plan to stem the nation's growing suicide rate without addressing the nation's growing use of suicide-linked drugs.
Antidepressants like Prozac and Paxil, antipsychotics like Seroquel and Zyprexa and anti-seizure drugs like Lyrica and Neurontin are all linked to suicide in published reports and in FDA warnings. (Almost 5,000 newspaper reports link antidepressants to suicide, homicide and bizarre behavior.) Asthma drugs like Singulair, antismoking drugs like Chantix, acne drugs like Accutane and the still-in-use malaria drug Lariam, are also linked to suicide.
The US's suicide rate has risen to 38,000 a year, says USA Today, after falling in the 1990s. The rise correlates with the debut of direct-to-consumer drug advertising in the late 1990s, the approval of many drugs with suicide links and more people taking psychoactive drugs for lifestyle problems.
Dr. Benjamin announced that federal grants totaling $55 million will save 20,000 lives in the next five years through suicide hotlines, more mental health workers in the VA, better depression screening and Facebook tracking of suicidal messages. Nowhere, including in the suicide-racked military, does she suggest looking at the overmedication which has gone hand-in-hand with the deaths. A month earlier, it was announced the Army has awarded $3 million to a scientist to develop a thyroid related nasal spray to combat suicidal thoughts, also ignoring overmedication.
Suicide increased more than 150 percent in the Army and more than 50 percent in the Marine Corps between 2001 to 2009, reported Military Times displaying graphs of the suicide and prescription drug increases, in a print edition, that are similar enough to be laid over one another. One in six service members was on a psychoactive drug in 2010 and "many troops are taking more than one kind, mixing several pills in daily 'cocktails' for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches--despite minimal clinical research testing such combinations," said Military Times.
Eighty-nine percent of troops with posttraumatic stress disorder (PTSD) are now given psychoactive drugs and between 2005 and 2009, half of all TRICARE (the military health plan) prescriptions for people between 18 and 34 were for antidepressants. During the same time period, epilepsy drugs like Topamax and Neurontin, increasingly given off-label for mental conditions, increased 56 percent, reports Military Times. In 2008, 578,000 epilepsy pills and 89,000 antipsychotics were prescribed to deploying troops. What?
Nor is the suicide rate going down as troops withdraw from Iraq and Afghanistan. In July, 2012, there were 38 Army suicides says USA Today and in July of 2011, there were 32. According to the Army's in-depth Health Promotion, Risk Reduction and Suicide Prevention Report in 2010, 36 percent of the troops who killed themselves had never even deployed.
Why are such drugs, which affect reaction time, motor skills, coordination, attention and memory even allowed during active duty? And why are they prescribed to soldiers who are at the exact age--young adults--that is most at risk for suicide according to warning labels?
Nor are troops the only cash cows for Big Pharma. One in four women are on psychoactive drugs according to published reports and millions of children are on psychoactive drugs, especially poor and those with disability status.
When the FDA first put suicide warnings on antidepressants for young people in the mid 2000s, Big Pharma linked psychiatrists like Charles Nemeroff argued that suicides would go up if doctors and patients were scared off by the black box warnings. Though the argument was absurd--is the nation fat because fen-phen was withdrawn?--the theory got play in the mainstream and medical press until it was proven wrong.
Yet as the Surgeon General and HHS proved this week, the government is still in denial about suicide and the elephant in the room called Big Pharma. Instead of spending millions on counselors, crisis lines, and "awareness campaigns" why doesn't it look at the millions it's spending on suicide-linked drugs? END
More information about overmedication of troops and suicide-linked drugs is found in Martha Rosenberg's recently published Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health available at Barnes & Noble, on Amazon and at public and school libraries.
