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 CVD (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.
I hope SEIU gets back to you about it as well.
Keep us posted!
I’m a bit concerned about the indignation that a “progressive organization” is being used in marketing. The real issue, I believe, is misleading direct-to-consumer advertising of prescription drugs. If the American Family Association acted as a marketing conduit to its members, would that have been more appropriate? Is it bad for the NAACP and OK for the White Citizens Council?
While I have not reviewed, at a detailed and statistical level, the current risk-benefit analysis of statins, the class of drugs is not without clear benefits in some groups, and possible benefits in others. While I agree that direct-to-consumer advertising, especially things like the Jarvik ad, are inappropriate, I am also sensitive that some “progressive” organizations have leaped on early reports of side effects and demanded the FDA withdraw the drug.
There’s little question that DTC television ads are not good for my blood pressure. For example, the advice to “call your doctor” if there is sudden vision loss with an erectile dysfunction drug is, IMHO, irresponsible. Any sudden loss of vision calls for a 911 call or speedy transport, obviously with someone else driving, to an ER with neurosurgical capability. Once the neurosurgeons clear the optic components of the nervous system, an opthalmologist might then be brought in. Sudden loss of vision is a medical emergency, if for no other reason than a threat to an important sense, but also as a possible indicator of a life-threatening neurosurgical emergency.
Risk-benefit is difficult, and I’m facing it very personally at the moment. I had been getting visibly better diabetes control while on Avandia with insulin. When the first meta-analyses suggesting increased cardiac risk came out, my primary physician asked me to review and summarize, which I did in a thoroughly professional manner. For a variety of reasons, we switched to Actos.
After several months of Actos therapy, my diabetes was radically improved. Unfortunately, I gained about 30 pounds, which was clearly fluid retention, a cardiac risk factor.
My physician wanted me to discontinue Actos, although he said he would leave the final decision to me. After a couple of months without it, my diabetes is far harder to control, and I am going to propose, to my PCP, specific cardiac evaluations. If I am not in heart failure, I want to go back on Actos, but with more aggressive diuretic therapy.
This is a complex set of tradeoffs that still will need testing and analysis. Is that kind of tradeoff evaluation something that reasonably can be expected of the usual target of DTC advertising?
Very strange politics.
Buy lets face it it seems to me that the IAEP/SEIU generally benefits from the perpetuation of the “disease sector” industry. IAEP in particular benefits from an emergency model of medicine.
After all if people weren’t labelled ill or having “emergencies” they might lose jobs?
My answer. SEIU must endorse more evidenced based prevention and must participate in the inevitable but painful transition from high tech expensive treatment based medicine to one which embraces prevention. This is an economic imperative.
IAEP/SEIU jobs must move into the prevention sector.
Dr. Rick Lippin
Southampton, Pa
You mean “CVD,” not “CVC.” Or was it like that in the original?
Marilyn
Does any of this really surprise you. Big Pharma is in business to make a profit. How they make their profit and the methods they use are questionable.
Do not be afraid to ask questions, and always follow the money trail!!!!
Dan, Howard,Rick, Marilyn, DrSH
Thanks for your comments.
I’m still waiting to hear more from SEIU. . .
The story has been picked up by a couple of other blogs, and will probably continue to be cross-posted.
Eventually, I’m hoping that this may lead the union to respond.
Howard– the problem with a “progressive organization” being used to sell a prodouct is that people tend to trust that the organization’s motives are pure. Union members assume the union has their best interests at heart.
In another example, Planned Parenthood took a substantial donation from Merck, and has campaigned for Merck’s newest blockbuster drug, Gardasil, ignoring the questions about Gardasil.
How much did the donation affect Planned Parenthood’s position on Gardasil? Impossible to know–though it hasn’t addressed the many questions about the potential risks of Gardasil and whether the money used to buy it might be used in way that would do far more to promote womens’ health.
Meanwhile, it would never occur to people who trust
Planned Parenthood that it
has a financial relationship with Merck.
Rick- Someone else has suggested to me that the union is not all that concerned about containing health care costs, since health care spending creates jobs.
You’re entirely right: we need to see more of IAEP’s jobs move into the prevention sector.
Marilyn– Yes, I meant CVD! Thanks for picking up on the typo. (It’s fixed now.)
DoctorSH– I completely agree. Following the money trail is often a very good way to understand what is happening–and why.
Following up on “progressive organization”, where you say that people tend to trust such organizations, I suggest there are organizations, with a different member base, that are still trusted.
This is sad as well as frustrating, as I was a weird kid, intensely interested in pharmacology and eagerly waiting for a chance to develop twists on antibiotic therapy. If you’ve ever read Mildred Savage’s novel, _In Vivo_, that was immensely exciting reading. My career didn’t go that way, but I still long emotionally for the days when the industry called itself “ethical pharmaceuticals”, and meant it. In my high school research, Schering opened their library and resources to me.
Now, however, if a conservative religious group gets a contribution, might it also push statins or other profitable maintenance drugs (which sometimes are essential). By overemphasizing the “progressive”, I fear you are compartmenting an issue that could be widespread. Myocardial infarctions do not recognize ideological spectra.
“You’re entirely right: we need to see more of IAEP’s jobs move into the prevention sector.” I think the unions should stay out of health care recomendations! I dont make union management recomendations! They are not equipped, experienced or educated enough to make recomendations about appropriate health care.
Dr. Matt & Howard-
Thanks for your comments.
Dr. Matt– I agree, unions are not in a position to
recommend specific medications.
Howard– I think you’re missing the point. It doesn’t matter whether the
group is progressive or
conservative. It shouldn’t be trying to practice medicine.
(My point about “trust” and progressive groups is that conservative groups are much more likely to support (and be supported by) for-profit organizations since they share some of the same ideas about markets etc.
When a progressive organization lobbies for a
for-profit corporation, people tend to be surprised, and to think there must be something really special about the product in question.)
For balance, I think you should also present the views of other physicians with respect to statins. John Abramson is entitled to his views, of course, but many people disagree with him. For instance, I know of no evidence that people over 65 who have heart disease don’t benefit from statins. There were many patients over 65 in the secondary prevention statin trials. After all, that’s who mostly gets heart disease.
I believe Pfizer is no longer using the Jarvik ads.
Marilyn
Here is a source for the part of my post relating to statins in the elderly. Afilalo et al., Statins for Secondary Prevention in Elderly Patients
A Hierarchical Bayesian Meta-Analysis, J Am Coll Cardiol, 2008; 51:37-45.
Marilyn–
Here are a range of views on statins (from the NYT), including the “Meta-Analysis” that you refer to:
“High-risk groups have a lot to gain,” said Dr. Mark Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician.
“But patients at low risk benefit very little if at all. We end up overtreating a lot of patients.” (Like the other doctors quoted in this column, Ebell has no ties to drug makers.)
“How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.
“You may have helped the heart, but you haven’t helped the patient,” said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Francisco, and a co- author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. “You still have to look at the impact on the patient overall.”
“A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didn’t lower mortality.
“Nor did they in a study called Prosper, published in The Lancet in 2002, which studied statin use in people 70 and older.
“Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.
“This month, The Journal of the American College of Cardiology published a report combining data from several studies of people 65 and older who had a prior heart attack or established heart disease.
“This “meta-analysis” showed that 18.7 percent of the placebo users died during the studies, compared with 15.6 percent of the statin users.
Finally, for another point of view, in an article for the British Medical Journal, Swedish physician and cholesterol expert Dr Uffe Ravnskov claims that little is known about the side effects of taking statins at higher doses.
“Dr Ravnskov and two other eminent colleagues have studied these side effects. They say there is a possibility of mental and neurological problems such as severe irritability and memory loss, and muscle weakness (myopathy) — this can make walking difficult, cause aches and pains, and in rare cases leads to total muscle cell breakdown, and kidney failure.
“I’m in touch with about 80 to 90 scientists who believe the benefits of statins have been overplayed and that the side effects are not being taken seriously enough,” he said.
“These ‘sceptics’ dispute many of the claims being made for the benefits of statins, and question the interpretation of the results of large clinical trials — they argue that some which are used to justify the use of the drugs actually show no difference in survival rates between those who took statins and those who did not.
“A major area of dispute is about who actually benefits from the drugs.
“The sceptics argue that statins have not been shown to prevent premature death among men over 65.”
The key point is that people at high risk can benefit from statins. That includes people over 65 with heart disease.
Marilyn
Marilyn–
The question is whether the risk of side-effects (extreme memory loss that looks like Alzheimers, extreme muscle pain and ultimately, damage to muscles) equals the possible benefits for people over 65.
The risk of side effects and the side effects themselves are much more severe for older patients. If you look at the comments on my Cholesterol Con story on Alternet (www.alternet.org), you’ll find that the vast majority of the many older patients who commented said that they went off statins because of the side effects–and are very glad they did.
What is unfortunate is that so many doctors urged them to stay on statins. Apparently the doctors had been brain-washed by the drug-makers’ publicity, but the patients knew how they felt. (And since doctors are paid fee-for-service to monitor cholesterol levels, this may have provided an additional incentive for some to promote statins.)
Many good doctors will tell you that a patient should always listen to what his body is telling him. This is another piece of medical evidence that shouldn’t be ignored.
Ms. Mahar never contacted us.
SEIU Does NOT Endorse Lipitor or Any Other Product
Official Statement from SEIU:
Recently, a letter appearing to endorse a well-known pharmaceutical was circulated by the International Association of EMTS and Paramedics, an affiliate of the National Association of Government Employees (IAEP/SEIU).
SEIU does not endorse products. The letter was generated by a Local Union staff member unfamiliar with SEIU’s policy against any product endorsement. Upon learning of the letter, the Local disavowed a relationship with the product in keeping with the union’s policy.
###
The 1.9 million member Service Employees International Union is united by the belief in the dignity and worth of workers and the services they provide and dedicated to improving the lives of workers and their families and creating a more just and humane society.
SEIU members are winning better wages, health care, and more secure jobs for our communities, while uniting their strength with their counterparts around the world to help ensure that workers, not just corporations and CEOs, benefit from today’s global economy.
I did indeed contact the union-as detailed in my post where I give the names of the people I contacted.
It is interesting that the union’s reply to my post on Healthcare Renewal is signed “Anonymous”. And here, too, the person who wrote this reply gives no name. If this is an official statement of SEIU, why is no name given??
Finally the person who signed the letter was not a “union worker.” He was
“Matthew Levy, Director of IAEP.
This “official reply” makes me want to do a little more investigating.
I apologize for not including my name – I thought I had. It was very late and I was trying to make the many rounds of blogs that picked up your article and reported it as truth.
Yes, the staff person at IAEP made a mistake. It was immediately addressed and remedied. If you contacted SEIU, you would have been given the correct information. We regret that the incident happened and we want to make clear to all your readers that in strict adherence of our policies established by our governing board, SEIU does not endorse drugs or any other product. I appreciate your help in making sure people are not misinformed.
Thanks very much,
Michelle Ringuette
Service Employees International Union
202 730 7234
media@seiu.org
Maggie,
Your post has been well-received at redscrubs.com. In fact, it has made this week’s Honorable Mention list of our Weekly Wrap-up. Each week we choose a Scrubby Winner, and approximately four Honorable Mentions. The Scrubby Winner receives a free pair of red scrubs. Keep up the good writing.
Sincerely,
Dr. Incognito
Michelle A Ringuette, SEIU
Thank you for providing your name. But if you take a look at my most recent post about SEIU, you’ll see that Matthew Levy is far more than a “staff employee” of the union.
He is listed as one of the ten top union leaders, has been with the union since 2001, and earns over $91,000.
Dr. Incognito–
Thank you!
They fretting us. There is no cholesterol at all.
Dr. Fernandez shouldn’t be to suprised about Labor endorsed drug product/products..it was only a matter of time..everything is about money these days…so they wanted a piece of the actions (read $$) and they decided to do whatever it takes..and well here we are…
Does any of this really surprise you. Big Pharma is in business to make a profit. How they make their profit and the methods they use are questionable.
Do not be afraid to ask questions, and always follow the money trail!!!!
ll the rejection he requires. Cole Smithey ColeSmithey.com
So should this attention, should enhance the prevention, early detection, early treatment