Women in Government, Merck's Trojan Horse: Part Three in a Series on the Politics and PR of Cervical Cancer
In this article, we'll analyze the push for mandated HPV vaccination of adolescent girls that is taking place at the state level throughout the U.S., and the non-profit organization, Women in Government (WIG). WIG has been Merck's non-profit front and direct channel to state-level legislators who are the key to enacting mandates.
The Push for Mandates, and the Pushback
As reported previously, Merck laid the PR and "education" groundwork for Gardasil well before FDA approval was granted in June 2006. But even with FDA approval and the strong recommendation of the Advisory Committee of Immunization Practices at the federal level, mandatory vaccination was not a given since the power to enact such requirements lies in the hands of state legislators. Merck was working behind the scenes on that front as well, and moved quickly to persuade policymakers with the authority to mandate vaccination for 11 to 12 year old girls. Within a few months of FDA approval, almost twenty states had legislation pending that would mandate vaccination against HPV. Merck must have felt like they had won the lottery when within a month, the Centers for Disease Control (CDC)'s Advisory Committee of Immunization Practices (ACIP) recommended that 11 and 12 year olds be targeted for routine vaccination, and all women 12-26 years old be encouraged to be vaccinated. Merck and Gardasil were on a roll, thanks in large part to Women in Government.
According to their website, "Women in Government is a national 501(c)(3), non-profit, bi-partisan organization of women state legislators providing leadership opportunities, networking, expert forums, and educational resources to address and resolve complex public policy issues." The campaigns that they feature on their home page deal with kidney health, Medicare preventive services, higher education policy, and the "Challenge to Eliminate Cervical Cancer," which was publicly launched in 2004.
On February 2, 2007, Texas Governor Rick Perry, against the wishes of his conservative base and to the surprise of critics, signed an executive order mandating HPV vaccination for girls entering seventh grade. Then, unfortunately for Perry and Merck, details of his many connections with both Merck and Women in Government became public. Ellen Goodman of the Boston Globe noted, "It turned out that Perry's former chief of staff is now a lobbyist for Merck. Did that look bad? Whoa, Nellie. Did it look bad that Merck had funded an organization of women legislators backing similar bills? Whoa, Merck." USA Today reported that Perry's current chief of staff's mother-in-law, Texas Republican State Representative Dianne White Delisi, is a state director for Women in Government. Perry's wife, Anita, a nurse by training, addressed a WIG summit on cervical cancer in Atlanta in November 2005. Perry also received $6,000 from Merck's political action committee during his re-election campaign.
Merck announced on February 20, 2007 that it would no longer lobby directly for vaccine mandates at the state level. The New York Times quoted Dr. Richard M. Haupt, executive director for medical affairs in Merck's vaccine division as saying, "Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and Merck's involvement in that are being viewed as a distraction to that goal." Dr. Haupt did say, however, that Merck would continue providing health officials and legislators with education about the vaccine and would continue lobbying for more financing for vaccines in general. When asked how much Merck had spent on its Gardasil lobbying efforts, Haupt declined to name a figure.
Women in Government: Picking Up the Slack for Merck
So who is this group receiving Merck funding and pushing for vaccine mandates across the country? As noted above, Women in Government had identified cervical cancer as a focus of their work as early as 2004. Available on the WIG web site is a legislative policy toolkit. It provides legislators with sample legislation written by their colleagues in other states, maps showing states with cervical cancer related bills pending or laws enacted, WIG's fact sheets on HPV and cervical cancer, and a letter from WIG President Susan Crosby. While not focused solely on introducing and enacting HPV vaccine mandates, they are a main component of the WIG campaign and something by which they measure success. According to a map that WIG provides on their site, as of June, 2007, twenty-three states and the District of Columbia have introduced HPV vaccine mandate legislation, in addition to Virginia, which has already enacted legislation.
WIG's non-profit and non-partisan status has given them access, status and influence beyond the reach of Merck, the vaccine manufacturer. Debbie Halvorson, the Democratic majority leader of the Illinois State Senate, had a hysterectomy due to HPV infection. She told the New York Times that, "she would continue to press for the bill, but that it was a good idea on Merck's part to stop lobbying. 'If the people out there are thinking that Merck is doing all this, and pushing our buttons, they need to just step away. The fact that I'm doing what I'm doing has nothing to do with Merck.'" Halvorson is listed as a current member of Women in Government on the group's website. Health Policy Monitor, the website of an international non-profit network on health policy and reform, reports that in California in late 2006, Democratic Assemblywoman Sally Lieber introduced a bill that would require all girls entering sixth grade to be vaccinated against HPV beginning in July 2008. "Assemblywoman Lieber has publicly stated that she drafted the HPV mandate for California because of the unique opportunity it presented to prevent cancer with a vaccine-something that has never before been possible. ... Merck representatives requested a meeting with Lieber before she introduced the HPV bill, but Lieber declined. Lieber did meet with Women in Government, unaware of their ties to Merck."
Straight From the President's Mouth: An Interview with Susan Crosby
In March 2007, I interviewed Susan Crosby, the President of WIG. Crosby first served on the board of WIG and then joined the staff as Deputy Executive Director in 2002. Crosby was a Democratic member of the Indiana House of Representatives for 12 years prior to her tenure with WIG. In 2005 Crosby's total compensation package from WIG was $123,925.
When asked what WIG offers its members, Crosby noted that besides the networking opportunities, WIG itself serves as a resource in several ways, including, "having legislators be able to call in and get totally unbiased information ... to be able to make decisions that are the best for their state." She continued, "That's one thing that we at Women in Government have always tried to do, is try to give them the full picture, the balanced picture - the good, the bad, and the ugly. Because nothing's worse than to give a legislator, a woman legislator in particular, part of the story, and have her go back to her state, standing up at the mike, proposing something, and all of a sudden this question comes flying out of left field and she has no idea what it was."
But is WIG dedicated to giving women legislators unbiased, balanced information, or in giving WIG's corporate contributors access to the legislators that can significantly help or harm their interests at the state level? In 2004, more than 20 WIG funders were pharmaceutical companies or entities heavily invested in health care issues that could come before state legislators. A short list includes both Merck & Co., Inc and Merck Vaccine, GlaxoSmithKline (which will soon have the second HPV vaccine on the market), and Digene Corporation (which manufactures an HPV test). Other drug interests listed as donors to WIG include Novartis, Eli Lilly, AstraZeneca, Bayer Healthcare, Pfizer, Bristol-Myers Squibb (both the company and their foundation), and Pharmaceutical Research and Manufacturers of America, also known as PhRMA, one of the largest and most influential lobbying organizations in Washington representing 48 drug companies.
WIG's funding rosters for 2005 and 2006 have minor additions and deletions, but Merck, GlaxoSmithKline, and Digene remain constant. It appears that word has gotten around that WIG is ready, willing and able to cooperate with those invested heavily in health care policy -- their current list of donors for 2006 includes more than 40 companies or organizations involved in the health field.
How did HPV and cervical cancer rise to the top of the short list of issues that WIG prioritizes? Crosby said that health has always been a focus of WIG's work. "Four years ago we heard about HPV, and I must tell you, at that time we didn't know the difference between HPV and HIV. We couldn't even say 'Human Papilloma Virus' and they were saying 'Oh! This is the virus that causes cervical cancer.'" WIG created a task force to look into it and "found out about this test that, used along with your Pap test, could predict 99.9% whether you had this virus and we thought, 'Oh my golly! Talk about some opportunities here. This is unbelievable information and we need to make this available to all women!' They need to know, when they go in to their doctor, to say, 'I want an HPV test as well as my Pap.'"
When I raised the issue of Merck pushing for vaccine mandates when it is currently the only vaccine provider, Crosby responded that GlaxoSmithKline has now also presented their drug, Cervarix, for FDA approval. When I noted that Merck, GlaxoSmithKline, and Digene, were all WIG funders, Crosby responded "and so is Eli Lilly, Bristol Meyer Squibb -- you could go on and on because of the health issues that we have championed for years. Obviously, we are going to attract the attention of that particular industry."
WIG funders also include energy concerns, casinos, alcohol, telecom interests, Big Tobacco, and lobby firms - all of which could be either significantly helped or harmed by state-level legislation. Does Crosby feel such funding compromises WIG, or creates the impression that WIG might have divided loyalties or interests? "I don't," Crosby replied. "Because number one, I think it shows that there is not one single industry or one corporation that is driving Women In Government. ... This is an affirmation that we are a totally unbiased, unprejudiced group, that we are trying to gain information - the pros and the cons - on all issues and being able to present that to our legislators for them to be able to make informed decisions on good public policy."
Crosby emphasized that the funding provided by corporations and industries are unrestricted grants. "To me," she explained, "I don't see it as a conflict of interest because they're not funding a particular legislator or a particular mission." But the funders are getting direct access to state legislators, in part through WIG's Legislative Business Roundtable. Crosby explained, "They are people that come together to help the women legislators identify what the cutting edge issues are. For instance, we might have someone from Verizon saying, 'OK, we're looking at telephone deregulation - this may be an issue you want to get more information on to help educate your legislators.' Because there's no way that we have the expertise to know what some of the coming issues are going to be. So they float those topics out there and we say, 'Oh, that's something we definitely need more information on.'" I asked whether, since Verizon is a WIG funder, it is safe to say that funders are among the members of the Roundtable. Crosby confirmed that they are.
WIG is also taking funding from the likes of Altria (formerly Philip Morris) and beer maker Anheuser-Busch. Not exactly stars in the health promotion pantheon. Referring back to her assertion that WIG wants to provide women legislators with the good and the bad, the pro and the con, of each issue, I asked if there is really a pro side to Big Tobacco, pointing out that on an archived web page listing previous WIG funders, they listed Altria Group just across from a box that read "November is Lung Cancer Awareness Month." Crosby replied, "We're putting the message out there, and it's up to Altria. They know that we are going to continue to give both the pros and the cons on that particular topic and they're not going to dictate to Women in Government, just like no business dictates to Women in Government. ... It's up to Altria if they still want to come to the table and they do."
"Perceived" conflicts of interest are not enough for WIG to refuse corporate funding. "I'm sorry that it has happened," Crosby said, "but I would say that if you know our women legislators, ... you know that no one particular person or industry is going to tell them or dictate to them what they're going to do. It's just so sad that they've lost the focus that this might be the medical breakthrough of the century - a vaccine against cancer."
Crosby predicts that, when years in the future people look back at this debate, "All this hoopla will be moot." But some former WIG supporters disagree. In early January 2007 WIG held their annual state directors conference on San Marco Island, Florida. Two of those attending were Marilyn Canavan and Andrea Boland, both Democratic state legislators from Maine. Both were surprised by the tone of the sessions devoted to HPV, cervical cancer and mandatory vaccination. Canavan later told Terry J. Allen, who was writing for CorpWatch, 'The tenor of presentations - they were not discussions ... (they) seemed one-sided to me ... I remember thinking as I was leaving the meeting, 'I just don't want to do this ... we need to have public dialogue.'
"Boland also reported a 'pull to get on board [promoting vaccination]... and when I raised questions, the response was 'Do you want your daughter to die of cancer?'" As a first-time attendee, Boland was struck by the role that corporations played in determining the policy priorities for WIG. "'When discussing what the agenda for next year would be,' participants were told to 'wait to see who's funding things.' Similarly before fixing the program for next year, they 'had to see what the sponsors want.'"
Canavan, a four-term legislator and a WIG state director, resigned from WIG on March 2, 2007. "An organization that stands to profit, like a pharmaceutical company, shouldn't be driving the health agenda in the public realm. You see so many front organizations, I'm not going to say Women in Government is one, but it matters who's funding them." She concluded, "When we lose trust in companies like pharmaceuticals or a group like Women in Government, we start to become suspicious about everything. We need to have public dialogue. The point is not that the vaccine is bad, but that the public agenda has all been company-driven."
How It Plays Out in the States: Wisconsin as a Case Study
In Wisconsin, State Senator Lena Taylor, a Democrat representing Milwaukee, plans to introduce legislation that would ensure HPV education and would lay the groundwork for an eventual HPV vaccination mandate. Taylor is a long-time member of Women in Government.
One concern regarding Gardasil and mandating its use is the creation of a false sense of security for girls and their parents. For example, on Senator Taylor's website (see below) until June 2007 was a statement boasting of the the introduction of legislation "that would add the vaccination for HPV, which is linked to 99.7% of cervical cancer cases, to the list of required vaccines for Wisconsin girls entering sixth grade. This legislation can end cervical cancer, which kills 3,700 women each year, in the next generation of Wisconsin women." Asked about the clear overstatement of the vaccine's benefit Taylor's Legislative Assistant Jeff Pertl conceded that the original posting was in error. "We've changed the language on that, to be candid. ... The initial number we were given by the medical community was that 99.7% figure. The general number we've been seeing in the press is 70%, which I think is a more conservative number, and that's number we've been using now. I would argue that I think it's higher than that, but in general we've moved to the more conservative number."
On the issue of negative publicity caused by Merck's heavy-handed lobbying efforts, Pertl said, "We've consciously tried to keep some distance from Merck, you know they got some national attention, but they haven't really been involved here in Wisconsin. ... We're trying to make this about the public health issue. Our bill's bi-partisan and we're trying to stay out of the quagmire wherever we can."
Regarding the links between the drug companies and Women in Government, of which Senator Taylor is a long-time member. Pertl dismissed a correlation between her membership and her work on this legislation. He said that "while Women in Government did push this issue in a lot of areas," Taylor's office had gotten more information and model legislation from the National Conference on State Legislatures (NCSL) than from WIG. "We didn't get a lot of contact from Women In Government, and it certainly wasn't like a lobbying effort, at least not that we were aware of. Again, I can't speak for the whole country, but I suspect it's a bit overblown, but it's hard to say." Like WIG, NCSL is also funded by corporations, including Merck and GlaxoSmithKline.
Did Senator Taylor disclose to her colleagues that she is a member of a group that receives financial support from those corporations? Pertl replied, "We didn't actually know that Women in Government receives funding from Merck until the news story broke, much like everybody else. We just didn't pay that much attention to the finances, quite frankly." Addressing the question of revealing WIG's funding to prevent any perceived conflict of interest, Pertl continued, "When we found out, we had a conversation with others - there are a lot of members of the legislature here that are members of Women in Government ... it really wasn't a major concern here."
Pertl concluded with this point. "I think there are two things that are spiking concern right now, if I can be candid. One is that HPV is a sexually transmitted disease. If this were transmitted in any other way, we probably wouldn't be having this conversation. ... The second problem is that if you pass the law today, the news story is today, even if the implementation is two years from now. ... And I think that's why we might do an education bill first. ... Because here's the most important thing - the public has to have faith."
Meaningful Analysis: Missing In Action
Legislative Aide Jeff Pertl touched on an important, and unfortunate, aspect of the HPV vaccine issue. Within a polarized political and religious climate, some conservative organizations and leaders are against the mandating of HPV vaccines due at least in part to a concern about encouraging promiscuity, and this has produced a knee-jerk reaction. Instead of carefully examining the issue, the response from some has been to endorse the vaccine simply on the grounds that if the Right is against it, they should be for it.
For example, in the Spring 2007 issue of Ms. magazine, this response, and the rampant oversimplification and misinterpretation of the HPV vaccines use and efficacy, is apparent. The author, Cindy Wright, discussed the overturning of Texas Governor Rick Perry's executive order mandating vaccination. But she credits the "firestorm" to social conservatives, not to the controversial ties between Perry, his wife, Women in Government, and Merck outlined above. In response to the $400 price tag quoted for the three shot regimen (and it might cost even more), she opines, "Even if I had to pay full price, how could I say no to the first-ever cancer vaccine? How could anyone? Who would consider not giving our daughters the best chance of avoiding a deadly disease?" In fact, regular Pap tests are still the best way to detect pre-cancerous conditions and to treat them well before they become cervical cancer. Wright's tone is reminiscent of George W. Bush claiming, "You're either with us, or with the terrorists." The implication is that if you're not running to get your daughter vaccinated, someone should call Child Protective Services.
The Ms. article ends with exactly the attitude that the Gardasil PR has encouraged, and Merck has been loath to correct. Wright concludes, "Meanwhile, my daughter has gotten her second booster. That's one less life-threatening illness to worry about." Is it any coincidence that Merck's crowning PR push was built around the phrase "One Less"? Let's hope that Wright's daughter does her homework more thoroughly than her mother and doesn't assume that she is now fully protected against cervical cancer. That misperception is what is truly life-threatening.
It is possible to be supportive of the vaccine and widespread access to it without favoring mandated vaccinations. And it is certainly not just the Religious Right that opposes HPV vaccine mandates being put in place at the state level. In February 2007, the American Academy of Family Physicians cautioned that it was "premature to consider school entry mandates" for Gardasil "until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified. USA Today quoted Joseph Bocchini, chairman of the American Academy of Pediatrics' Committee on Infectious Diseases, as affirming Merck's February 2007 announcement to discontinue its direct lobbying efforts in favor of vaccine mandates. "At this point," Bocchini said, "we really don't know whether we even need to consider a mandate. We need to get some data over time."
Dr. Diane Harper, whom I quoted at length previously in this series, has serious concerns about mandating the HPV vaccine for middle-school aged girls. Dr. Harper was involved in designing and implementing clinical trials for both Merck's Gardasil vaccine and GlaxoSmithKline's Cervarix. According to Dr. Harper, eleven- and twelve-year olds have had safety testing, but not efficacy testing. This means that there is no way to tell how long Gardasil will provide protection, or when a booster shot might be needed.
So why focus on that age group? "That age range was targeted because the manufacturer has this vaccine, and they need to recoup their R&D (research and development) costs. ... But how do you administer this vaccine? How do you package it and put it out there so that it makes sense to the public and so that the right public health programs and different sub section of the medical community 'own' the vaccine?"
Part of the answer is that mid-adolescence is a good age because vaccinations given in early childhood are coming due for a booster, and there is a growing realization that many risky behaviors and conditions, like smoking, depression, and obesity, are emerging at the that age as well. The manufacturers and the CDC decided to add the HPV vaccine to a platform of vaccines to give at that age, including meningitis, pertussis and tetanus updates, pneumococcal vaccine." Dr. Harper continued, "I think that's a very noble thought, and that it's a thoughtful way of thinking of where to place the vaccine. The problem is that in so doing, you lose the concept of what the vaccine was for, the actual power of the vaccine. It gets folded into the bigger purpose of helping adolescents have a better health life. But you lose the fact that women continue to get HPV infections throughout their lives -- there is no one age when cervical cancer stops. It pigeon-holes the vaccine into something for twelve-year olds, it also pigeon-holes it into a wedge to start talking about sexuality."
I asked Dr. Harper to explain her opposition to mandating the vaccine when she was prominently featured on the agenda of a Women in Government summit on cervical cancer held in Bay Harbor, MI in July 2005. She replied, "My talks and discussions at that meeting were identifying the benefits (not the limitations) of the HPV vaccines as they were being developed. My talks served as an educational platform so that the benefits scientists were seeing from the clinical trials could be explained to the legislators in a way they could take back to their legislative bodies." She continued, "At the time I was working with WIG, the concept of mandates was either not discussed or very embryonic in form. ... There was not consensus on the age at which to vaccinate women with the HPV vaccine, this would not come from the ACIP until November 2006 with the wording that 11-12 year olds would be targeted for routine vaccination, and all women 12-26 years old would also be encouraged to be vaccinated. The Merck representative to WIG was strongly supporting the concept of mandates later in the WIG meetings and providing verbiage on which the legislators could base their proposals."
Dr. Harper reiterated her position to "fully support the use of the HPV vaccine for women of all ages, and support health insurance, third party payers to cover this for preventive women's health care. I do not support the concept of mandates for 12 year olds that keep children from school if there is insufficient access to the vaccine." She also indicated that she feels strongly that individual women legislators have a genuine concern for women's health.
WIG Isn't Alone: Other Ways to Buy Access to State Legislators
Women in Government is not alone in providing its corporate funders with direct access to the state legislators that can help or harm their corporate interests through state-level legislation. The National Foundation for Women Legislators, which works with women in all levels of elected offices, unabashedly outlines the access to legislators that Corporate Membership levels, ranging from $5,000 to $50,000, will buy. At the $50,000 President level, corporate members can "host (a) conference call with key legislative members on policy issue" and can also mail to the NFWL membership list four times during the year. President and Senator ($35,000) level corporate members can also participate in NFWL leadership activities. NFWL stopped listing its corporate funders on its website in 2002, but at that time, they included Merck, Pfizer, SmithKline (pre-merger with Glaxo), PhRMA and other pharmaceutical interests, not to mention Philip Morris, Enron, the Chlorine Chemistry Council, the National Rifle Association, and Exxon. In a 1999 fundraising mailer sent to tobacco company Philip Morris, now Altria, NFWL promises that "by joining the Corporate Leadership Circle of the National Foundation for Women Legislators, you will have the opportunity to lend your expertise and point-of-view to lawmakers at a number of high-profile, yearly events."
The NCSL Foundation, which is the 501 (C) 3 non-profit that raises funds to support the programs of the National Conference of State Legislatures, outlines the benefits on becoming a gold ($10,000) or silver ($5,000) sponsor of NCSL. Benefits include varying levels of access to the NCSL leadership and to the member legislators, including being able to serve on one of the Conference's sub-committees. The NCSL Foundation lists its funders as including the usual suspects of pharmaceutical firms (Merck, GlaxoSmithKline, Pfizer and others, including the lobby group PhRMA), in addition to energy, telecom, and other deep-pocketed interests. NCSL has a briefing page on HPV and what is happening at the state level, but does not appear to have yet taken a pro-mandate stance.
The American Legislative Exchange Council, a network of conservative legislators that pushes legislation that favors big business and rollbacks of environmental regulations, also provides direct access and influence to its corporate funders. ALEC's Health and Human Services task Force lists individuals from GlaxoSmithKline, Bayer Health Care, and PhRMA as private sector representatives. At their April 2007, Task Force Summit meeting, the co-chairs announced the formation of a one-time Health and Human Service Working Group on HPV vaccination mandates. This working group will present on the mandate issue at the ALEC annual meeting at the end of July in Philadelphia.
What Have We Learned?
These first three articles on the Politics and PR of Cervical Cancer have attempted to untangle the issues surrounding an important health care topic as it has played out in the U.S. We started with a basic analysis of the facts around cervical cancer, and what Merck has to gain by having the first vaccine on the market. We've looked at the award-winning PR campaign that Edelman produced for Merck and the non-profits, Cancer Research and Prevention Foundation and Step Up Women's Network, that helped create a culture of fear couched in the empowerment of women and girls. We've looked at the lobbying efforts to push for state mandates of HPV vaccination which has been channeled through industry-funded non-profits like Women in Government. And we've outlined the concerns that all the hype and spin are a grave disservice to women's health. Merck's greed, and the willingness of its partners to go along with an industry driven campaign, have compromised the actual promise of the vaccine.
In the fourth and final article, "Profit Knows No Borders, Selling Gardasil to the Rest of the World," we'll examine developments in other countries around the issue of HPV vaccination.