18 July 2007 at 9:58:03 PM
How Does Big Pharm Buy Access to State Legislators? Especially if they don't want to look like they're directly hand in glove with the states? Why, go give your pitch, as well as a lot of money to 5013c companies that will then go back and pass legislature on your behalf. And, sadly, this particular group, Women in Government, doesn't see anything skewed about this at all.
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.
Part 1, Part 2 and Part4 of this series on HPV are at those links.
So far, Merck had encouraged women to "Make the Connection" and "Make the Commitment." Those were low-key efforts compared to the most significant pre-approval effort -- the "Tell Someone" commercials. This is not a new technique by any means. In his 1928 classic, "Propaganda," father of the modern PR industry Edward Bernays described at length how it is not enough to sell a product. Instead, you need to sell the vision that will lead to desire for the product, with the consumer believing that it is their own idea. The "Tell Someone" spots did not mention Gardasil since it was not yet FDA approved, but did include Merck's name and logo. They showed actors portraying everyday women being shocked that HPV is so prevalent and that there is a link to cervical cancer. "I was stunned at how many people have HPV. I was stunned. Millions? That's insane," says one woman. With a sense of urgency, all the women pledge to tell someone they love, while pointing to a speech bubble on their plain white t-shirt that says "Tell Someone."
In a May 2006, article, Bloomberg News' Angela Zimm and Justin Blum noted that not everyone was taken in. "Gary Ruskin, executive director of Commercial Alert, a consumer group based in Portland, Oregon, that is critical of drug company advertising, said Merck's promotional Web site on the viral connection to cervical cancer is 'deceptive and dishonest. Merck doesn't tell you why the site exists, which is to sell Gardasil,' Ruskin said." Kelley Dougherty, the Merck spokeswoman, protested that the campaign wasn't about Gardasil. "This campaign is part of a broad and longstanding Merck public health commitment to encourage education about the disease."
However, the Bloomberg article also cited Richard Haupt, executive director of medical affairs in Merck's vaccine division, stating that the company has "invested in public affairs and consumer education more than we've done for any vaccine in the past." (emphasis added.) The Bloomberg reporters calculated that Merck spent $841,000 for Internet ads on HPV's link to cervical cancer in the first quarter of 2006 alone. In April 2006, they bought 295 TV advertising spots for the HPV campaign, followed by 788 spots in May. It wasn't until June 2006, that the FDA approved Gardasil.
What about free vaccinations?
The idea of mandating HPV vaccination for girls as a requisite for school attendance may seem helpful, or at worst benign, but this isn't the case. Government mandates often create requirements, but not the funding to fulfill them. Even a government recommendation can have far reaching effects on access. On June 8, 2006, the U.S. Food and Drug Administration approved Gardasil as the first vaccine against Human Papillomavirus (HPV). Less than a month later, the Advisory Committee of Immunization Practices (ACIP) unanimously recommended vaccination for 11 and 12 year old girls. According to the Oncology Nursing Society, the ACIP also "resolved that the HPV vaccine be included in the Vaccination for Children (VFC) Program, a national effort that provides free immunizations to children who are Medicaid eligible, uninsured, underinsured, or Native American. 'About 40%–45% of the U.S. child population is included in the VFC,' said Lance Rodewald, MD, of the Immunization Services Division.'"..
This may sound positive, but Dr. Diane Harper sees it differently. Dr. Harper is a Professor at the Dartmouth Medical School and has been studying HPV for almost 20 years. She was involved with both Merck and GlaxoSmithKline in HPV vaccine trial design and served as a principal investigator at the clinic site for both the phase two and phase three trials for Gardasil and Cervarix.
In our interview, she stated that this federal directive to provide the vaccine free to such a large segment of the U.S. child population falls to the states, and federal funding covers at best 10% of the cost of the program. So the federal government is requiring states to cover the children, and the states themselves might choose to make the vaccine mandatory for school attendance. But 90% of the children who would in theory receive the shots free won't, and so parents will have to pay for the shots out of pocket or risk their daughter being barred from going to school. And those children that are covered by private insurance? Dr. Harper explained further that particularly with a drug as expensive as Gardasil, its inclusion in the Vaccination for Children program provides insurance companies with a perfect reason not to cover the shots for anyone under 18 years old beginning July 1, 2007.
"Insurance companies are saying that VFC program is required by law to purchase this. But the problem is that the states don't have enough money allocated by VFC to purchase enough to cover their whole state's population. So if you make a mandate that your child can't enter sixth grade as a twelve-year old without having the shots, and your state only has enough to give it to 10% of the twelve-year olds, and you're the next kid in line and your family doesn't have $500, then you can’t go to school. And that is wrong."
According to the National Center for Children in Poverty at Columbia University, 18% of children in the U.S. live below the federal poverty level ($20,650 a year for a family of four) and 38% of children live in low-income families. There is obviously a huge gap in coverage for those who can't afford the shots on their own. For most families, said Harper, "it would be an onerous amount to pay. And it would be awful to link your further education with your inability to pay for a vaccine."
Merck used its deep pockets to make sure that even before the FDA had approved Gardasil, there was a growing awareness of and concern about HPV and its link to cervical cancer. According to Bloomberg News, Merck spent $841,000 for Internet ads alone relating to HPV in the first quarter of 2006 -- months before the FDA had even approved Gardasil.
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