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March 20, 2008 Pfizer, SEIU and the "Cholesterol Con"
I heard about this a few days ago, but couldn't pursue it because I was tied up. So I'm reprinting the Health Beat Blog's story, by Maggie Mahar of the Century Foundation:
A couple of weeks ago Dr. Alicia Fernandez, an associate professor of clinical medicine at UC San Francisco, received a very unusual letter from The International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/ SEIU).
The letter began by noting that Fernandez is part of the union’s approved physician network, and then launched into what can only be described as a shameless sales pitch for Lipitor, Pfizer’s blockbuster cholesterol-lowering drug.
First, the alarming statistics presented in the letter:
1 in 3 adults has some form of CVC (cardio-vascular disease) About every 26 seconds, an American will suffer a coronary event Stroke is a leading cause of serious, long-term disability in the United States Every 45 seconds, someone will suffer a stroke.
Then, the endorsement: “Lipitor is available to our members through their prescription plan. IAEP leadership stands behind LIPITOR as the lipid-lowering agent of choice when it is prescribed by a physician. [my emphasis] This confidence in LIPITOR is based on its proven efficacy and is supported by its vast clinical experience of more than 15 years…"
The letter went on, at length, to praise Lipitor’s benefits and to downplay the drug’s risks. In clinical trials, the letter states, “the most common adverse events were constipation, flatulence, dyspepsia and abdominal pain.” But while other risks may not be as “common” they are certainly worth mentioning. They include memory loss which can look like Alzheimer’s and severe muscle pain.
A few days ago, Fernandez received a second, identical letter. Never before in her professional experience had she received a drug ad from a union.
“I’ve never seen anything like this. I’ve never seen Labor endorse a drug product,” she told me. “This is incredible.” Unfortunately, Fernandez adds, this is not the first time that she has seen a drug company use a progressive organization to promote its product.
In this case, the Lipitor letter is signed by “Matthew Levy,” the director of IAEP. “But this is clearly a joint production between the drug company and the union,” Fernandez notes. “Much of the letter is written in medical language—looks like it is written by Pfizer folks. And at the bottom of the second page of the letter there is a Pfizer copyright: ‘2007 Pfizer Inc. All rights reserved. Filed in USA/ December 2007.’ Yet it is written on the IAEP/SEIU letterhead.”
Why would Pfizer need the union’s help in peddling its drug? Lipitor, after all, is the best-selling drug in the world, with sales of almost $13 billion in 2006.
But recently, Lipitor has been attracting some decidedly negative publicity.
As regular HealthBeat readers know, in January Business Week published a cover story that asked “Do Cholesterol Drugs Do Any Good?", which blew the lid off the theory that “statins”-- drugs like Lipitor, Crestor, Mevacor, Zocor and Pravachol -- can cut the odds that you will die of a heart attack by slowing the production of cholesterol in your body and increasing the liver’s ability to remove L.D.L., or “bad cholesterol,” from your blood.
As I wrote at the time, the medical evidence shows that while these drugs can help some people they have been widely overprescribed. “Medical research suggests that only about 40 percent to 50 percent of the 18 million Americans taking statins are likely to benefit,” says Dr. John Abramson, a clinical instructor at Harvard and author of Overdosed America. “The other 8 or 9 million are exposed to the risks that come with taking statins--which can include severe muscle pain, memory loss, sexual dysfunction -- and one study shows increased risk of cancer in the elderly-- but there are no studies to show that the drugs will protect these patients against fatal heart attacks.”
Studies show that stains can help one group, says Abramson: “People under 65 who have already had a heart attack or have diabetes. But even in these very high risk people, about 22 have to be treated for 5 years for one to benefit.”
Congress also has been a casting a cold eye on Lipitor, charging that TV ads which feature Robert Jarvik, inventor of the artificial heart, banging the drum for Lipitor, “emotionally manipulate viewers, and underemphasize the potential side effects of the drug.
This may explain why Pfizer reached out to IAEP for help. But it doesn’t explain why IAEP's national director, Matthew Levy, agreed to put his name to the letter. A half dozen phone calls to IAEP, leaving messages for Levy, IAEP President David Holway, IAEP’s legal department and IAEP’s national communication’s director, Stephanie Zaiser, yielded only a response from Zaiser.
According to Zaiser, IAEP’s national president, Holway, had not known that Levy was sending out such a letter, and that IAEP has since made a policy that the organization does not endorse specific drugs. When I pointed out that letters were sent out as recently as a few days ago —and asked when the new policy was put in place-- she said she didn’t know. When I asked if IAEP had any financial relationship with Pfizer, or had ever taken a contribution from Pfizer, she said she didn’t know. When I asked whether Levy’s signing of such a letter, stating that the “union leadership” backed Lipitor-- without the knowledge of the rest of the union leadership-- had had any repercussions for Levy, she said she didn’t know. When I asked if she could go back and ask Holway those questions, she said “no.” When I asked for Holway’s phone number (which I subsequently found) she said she didn’t have it. When Holway’s assistant contacted him on his cell phone and told him that I was on the line, he said that the communications director had already answered my questions.
I concluded that IAEP really doesn’t want to talk about the Lipitor letter.
What is particularly disturbing, says Dr. Fernandez, is that this is not the first time she has seen a drug maker use a progressive organization for cover. Fernandez, who specializes in disparities in the medical care that people of different races receive, then told me a story about BiDil, a heart failure drug approved by the Food and Drug Administration for the treatment of African-American patients. In this case, the manufacturer persuaded the New England branch of the NAACP to back the drug.
“BiDil is not designed to target heart failure in African Americans. It is not even a new medication; actually it’s a combination of two older, generic medications that have long been approved for use among all patients with heart failure, regardless of race,” Fernandez explained. “NitroMed, the maker of BiDil, initially sought patent protection for this ‘new’ combo pill to market to all patients with heart failure. The FDA denied that request. “
“NitroMed then opted for the next-best strategy,” says Fernandez, “applying for patent protection for treating African-American patients with heart failure. The company argued its case both on the basis of science (the drug's efficacy had clearly been demonstrated in a study that included only African-American heart failure patients) and on the basis of combating racial disparities in health. The FDA agreed to approve the pill, but rather than issuing a broad- based approval (as it routinely does with studies that include only white patients), the agency made the unfortunate, and controversial, choice of limiting the drug's approval to the treatment of heart failure in African Americans.”
In 2007, Fernandez wrote an article about BiDil for the Annals of Internal Medicine. The FDA published a rebuttal. Meanwhile Medicare refused the cover BiDIL and The NAACP's New England branch accused the agency of racism. Sadly, “the venerable civil rights organization has fallen for the same marketing ploy that the FDA did in approving BiDil in the first place, and that could set a dangerous precedent in the struggle to end racial disparities in health,” Fernandez observes. She also notes that the Wall Street Journal reported that NitroMed had made a whopping $1.5 million grant donation to the NAACP.
Fernandez then wrote an Op-ed piece for the San Francisco Chronicle, describing how “NitroMed's strategy has paid off. Its combo pill now has patent protection, allowing the company to increase the price of the ‘new’ medication far above the cost of its two generic components. (BiDil costs about $3,000 a year more than its generic components). What's worse, though, is that the FDA's approval created the misperception of a race-specific drug effect and paved the way for more race-based marketing of pharmaceutical products.
“Marketing to particular groups is a lucrative strategy for many products, from soft drinks to cars,” she continued. “Harnessing the political rhetoric of the moment is not new. Virginia Slims successfully used the rhetoric of feminism to sell cigarettes with the iconic ‘You've come a long way, baby’ ad campaign, while ignoring the harmful effects of tobacco.
“That's what the FDA's approval has done for BiDil. Claiming a race- specific effect not only helped NitroMed gain patent protection, it defined a market niche. The use of civil rights rhetoric for BiDil masks the NitroMed's real goal: selling an expensive ‘new’ pill made from two cheap old ones.
“The issue here is not whether health plans should choose or be forced to cover BiDil, or how much profit NitroMed makes,” Fernandez added. “The issue is that the argument over coverage of BiDil deflects attention from the real issues involved in health disparities.”
“If we want to get at the root causes of disparities in heart disease, we need to look at a number of factors, such as under-use of common, standard therapies in African Americans, as well as inadequate preventive care. We need to pay attention to the complex social problems --most notably poverty and inequality-- that interact with human biology to produce poor health. And finally, we must recognize that eliminating health disparities also requires access to high-quality, affordable health care for all Americans--the important issue that Congress is rightly debating.
“The struggle to end racial disparities in health is too important to allow Congress, the FDA and civil rights organizations, such as the NAACP, to be sidetracked by marketing ploys under the guise of civil rights issues.”
Today, Fernandez added, “I’ve never been on the opposite side of the NAACP. I’ve been a big admirer of the SEIU, an extremely progressive organization. But now these drug companies are going to the good guys for cover.”
This brings me back to my question: Why did IAEP, a division of SEIU, decide to endorse Lipitor at this particular point in time? I’m still hoping that the union will get back to me with an answer to this important question.
Posted by gooznews at March 20, 2008 09:00 AM