Tuesday, February 10, 2009

Who Supports Fibromyalgia Patient Advocacy?

The Associated Press just published a story on the marketing of drugs for fibromyalgia, which provided a window into relationships among pharmaceutical companies and not-for-profit disease advocacy groups. One example was the National Fibromyalgia Association:

The drug industry's grants also help fill out the budgets of nonprofit disease advocacy groups, which pay for educational programs and patient outreach and also fund some research.

'If we have a situation where we don't have that funding, medical education is going to come to a screeching halt, and it will impact the kind of care that patients will get,' said Lynne Matallana, president of the National Fibromyalgia Association.

Matallana founded the group in 1997 after she was diagnosed with fibromyalgia. A former advertising executive, Matallana said she visited 37 doctors before learning there was a name for the crushing pain she felt all over her body.

A decade later, her patient advocacy group is a $1.5 million-a-year operation that has successfully lobbied Congress for more research funding for fibromyalgia. Forty percent of the group's budget comes from corporate donations, such as the funds distributed by Pfizer and Eli Lilly.

Pfizer gave $2.2 million and Lilly gave $3.9 million in grants and donations related to fibromyalgia in the first three quarters of last year, the AP found. Those funds represented 4 percent of Pfizer's giving and about 9 percent of Eli Lilly's.

Another example was the National Fibromyalgia Research Association:

Dr. Daniel Clauw of the University of Michigan said pharmaceutical industry market research shows roughly half are undiagnosed. People with fibromyalgia experience widespread muscle pain and other symptoms including fatigue, headache and depression.

Research by the University of Michigan's Clauw suggests people with fibromyalgia experience pain differently because of abnormalities in their nervous system. Brain scans show unusual activity when the patients experience even minor pain, though there is no abnormality common to all.

Clauw's work, however, illustrates the knotty issues of drug company funding. He has done paid consulting work for the drugmakers, and he's received research funding from the National Fibromyalgia Research Association, which receives money from the drugmakers.

By the way, the National Fibromyalgia Association's list of sponsors includes quite a few pharmaceutical companies in addition to Pfizer and Lilly:

Acorda Therapeutics
Cause Marketing, LLC
Cuddle Ewe
Eli Lilly
Forest Laboratories, Inc.
Ortho McNeil Pharmaceutical, Inc.
Pacific Life

The National Fibromyalgia Research Association's web-site is not so forthcoming, although I did find an acknowledgement that Lilly supported one NRFA conference in 2007 in the amount of $46,500.

This case illustrates the willingness of pharmaceutical companies (and likely other health care corporations) to support what appear to be grass-roots, not-for-profit disease advocacy groups when doing so coincides with corporate marketing objectives. Such "astroturf" organizations may help raise the profile of diseases for which the corporations market products, thus also helping to increase the market for these products, and may help further corporate health policy objectives.

With health care in flux due to new leadership in the US, and the global financial meltdown, look for stealth marketing and stealth health policy advocacy to increase.

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy.


Bernard Carroll said...

Fibromyalgia (FM) is one of those areas in medicine where pharmaceutical bottom fishing goes on. A good example is the effort by Cypress Bioscience to bring to market a drug called milnacipran for FM. This drug is a me-too antidepressant agent developed in France around 20 years ago, licensed in some countries, but never impressive enough to make it to prime time as an antidepressant in the US. So now it is being brought forward for FM. Considering that the FDA requires only that the drug beat placebo in at least 2 trials, no matter by how little, and no matter how many negative trials are recorded, we may soon see milnacipran in DTC advertisements.

The disreputable Charles Nemeroff pimped this drug in a notorious review article that appeared in Nature Neuroscience in 2002 – without disclosing that he was on the payroll of the company, big time. Melody Petersen exposed this, and other conflicts of interest that Nemeroff did not disclose, in the New York Times the following year – after Nature Publishing Group gave me and Robert Rubin the runaround for months about correcting the record. In the end, however, we were delighted to see the publisher change its policy on disclosures as we proposed. Other journals have followed suit. So perhaps something useful can come from bottom fishing.

Bernard Carroll.

Steve Lucas said...

We also see in the Feb. 10, WSJ article Drug Makers Fight Stimulus Provision by Alicia Mundy that the drug companies are not above focusing their lobbying machine on comparative testing. Part of the stimulus package is $1.1B in funding to NIH to do comparative testing.

When the standards are so low, better than a placebo, one has to wonder about the quality of all drug test given the history of spinning the result. Certainly some have stood the test of time while we have to question the rash of applications and those done solely for market considerations.

We have this quote:

"Companies "want to control the data, how it is reviewed, evaluated, and wheather the public and goverment find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program."

Kinda says it all.

Steve Lucas

Justice in Michigan said...

I find myself in the unusual position of not _entirely_ agreeing with the slant of folks I normally concur with.

It goes back to my own experience with what was then called "chronic fatigue" in the 80s. Five years of misery, everything else ruled out, yadayada. Eventually, a senior infectious disease specialist found immunological abnormalities that seemed to correlate with worst symptom periods. When that got better, do did these markers. Eventually, it all got better.

So I don't doubt the amount of bottom fishing. None of the anti-depressants than extant helped me a whit - they only made me feel like I'd had twelve cups of coffee and/or there was a hair drier in my throat. I doubt Lyrica and pals would have helped me either.

But my guess remains that there is medical science to be learned from _some_ patients who have this disesase, whatever it is called. And we would be mistaken to dismiss the whole deal as a pharma plot, as much as pharma may be trying to get the largest possible piece of the action.

Daniel Goldberg said...

To somewhat echo JiM's comments, I would hasten to add that the subject of my forthcoming dissertation is the undertreatment of pain in the U.S. The evidence is virtually beyond dispute that we treat pain, and in particular chronic pain, just terribly. This is not a problem of technical capacity -- we have the ability to treat most kinds of pain experiences far better than we do.

Thus, while I am obviously not in favor of any kind of stealth advocacy, and I applaud Roy and this blog in general for continually urging that the links and connections between industry and advocacy groups need to be made more transparent (and discussed), there are significant problems with the stigma and undertreatment that chronic pain sufferers endure.

I don't think the two issues are mutually exclusive. One can indeed voice the concerns Roy does, and simultaneously take quite seriously the liminality that persons with pain and other contested illnesses undergo. But it is a serious error to permit the legitimate concern with disease-mongering to exhaust ethical attention to the suffering and plight that, at least as to pain, is widespread.

Bernard Carroll said...

I do not disagree with JiM or Daniel Goldberg. But the bottom fishing trials of tired old drugs for FM are basically experimercials, not incisive clinical research. Worse, they tie up resources that could better be deployed to real clinical research that might actually answer the kind of question JiM describes.

Bernard Carroll

Bernard Carroll said...

I do not disagree with JiM or Daniel Goldberg. But the bottom fishing trials of tired old drugs for FM are basically experimercials, not incisive clinical research. Worse, they tie up resources that could better be deployed to real clinical research that might actually answer the kind of question JiM describes.

Bernard Carroll