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The second method in thought-leader making is to identify the rising stars whose research is consistent with the marketing message a company has for a specific drug. If a promising young doctor's research centers on the impact a healthy diet, exercise and certain vitamins have on Alzheimer's, for example, it's unlikely this doctor will be chosen to become a member of a pharmaceutical company's speaker bureau.
But if a psychiatrist says that he or she is seeing promising results in Alzheimer's patients treated with the anti-psychotic drug Seroquel, then the drug's maker, AstraZeneca, might make an overture. Seroquel isn't approved by the FDA to treat Alzheimer's, so AstraZeneca can't say it works that way. But a psychiatrist can. And to back the psychiatrist up, AstraZeneca might provide him with a few low-quality studies that say taking Seroquel is more effective in the treatment of Alzheimer's than taking nothing at all.
The next step might be to publish an article written by an AstraZeneca employee under that psychiatrist's name, based on a study the good doctor didn't conduct. It's called "ghost writing," and according to Fugh-Berman, it's all too common. In truth, all of this actually happened with Seroquel, and AstraZeneca paid a $520 million settlement to avoid criminal prosecution in April.
Even for discerning doctors, it can be almost impossible sometimes to spot the marketing angle when a drug company comes calling with a proposition. Take the cervical cancer vaccine Gardasil. Long before the FDA approved its use, you may remember a TV commercial that looked like a public service message, in which women on the street expressed shock when told of the prevalence of human papillomavirus (i.e., genital warts) and its connection to cervical cancer.
That commercial was the cornerstone of the "Tell Someone" campaign. Its backer was Merck, the HPV vaccine's patent holder. With FDA approval pending, Merck was only allowed to publicize the disease, not the vaccine. So if Merck approached an up-and-coming clinician studying the link between cervical cancer and HPV — asking the doctor to speak on the subject long before it planned to bring its vaccine before the FDA — that doctor might think, "Why not?" After all, it's only education: a public service, even. And yet the doctor unwittingly became a part of Merck's pre-release marketing strategy, selling the disease to create a customer base for its eventual treatment.
The messaging is similar for a doctor who belongs to a drug company's speaker bureau. It's the doctor's job to sell the disease. The drug rep sells the drug. Let's say a doctor's published paper touts a certain class of diabetes drug known by the acronym TZD as a potential method of diabetes prevention, instead of diet and exercise. And if Glaxo is already selling billions of dollars' worth of just such a drug — called Avandia — you have a match made in heaven.
Dr. Hal Roseman is a Nashville forensic cardiologist. The aforementioned TZD paper is his, published in the Journal of Managed Care Pharmacy and based on the proceedings of a symposium funded with an unrestricted educational grant from — you guessed it — Glaxo. Roseman is a member of Glaxo's speaker bureau, the company that pays most of his disclosed speaking fees; by our tally, he's the second highest-paid speaker in Nashville. A search of the national medical research database yielded no other published work under his name. Though he doesn't lack a medical pedigree — a degree from Yale and a fellowship at Brown and Massachusetts General Hospital — he has no current affiliation with any academic institutions.
That hasn't kept his profile low. If you followed the Senate Finance Committee hearings on Avandia back in January, you may remember him testifying on behalf of the drug, now linked to heart disease in diabetic patients. The Scene asked him if it was possible that the more than $240,000 he's made in speaker fees in the past year or so could cloud his judgment.
"If you have a drug that's shown benefit, you need an opportunity to make that known and propagate that knowledge and improve the branding consciousness of that particular drug," Roseman says. "Educational programs take place in order to help doctors do that. And I can tell you as a national speaker who's, from what I understand, one of the most paid — I'm not proud of it and I presume that's why you're calling me — but I speak predominately about disease state."
At the Senate Finance hearing, however, Roseman gave a PowerPoint presentation titled, "In Defense of Avandia," and one couldn't help but wonder if Glaxo was compensating him for his time and travel to Washington, D.C.
"I still am convinced that, number one, the absolute risk for myocardial infarction (heart attack), if it exists for Avandia, is low." Roseman tells the Scene, referring to the once-popular diabetes drug. "Number two, unlike some of my academic colleagues who would not go on the public record, they admit that the FDA based its decision on observational data and not randomized-, clinical-trial data."
While this may be true, during the hearing he went on to present five reasons why Avandia shouldn't be taken off the market. He cited data in a few Glaxo-funded studies he said pointed to an insignificant risk of heart disease. Here's the problem with that: As early as 1999, a University of North Carolina professor warned that Avandia could cause cardiovascular problems. Glaxo effectively silenced him by complaining to his superiors and threatening a lawsuit, according to testimony before the Senate committee.
In 2000, an internal Glaxo report obtained by investigators noted that Avandia raised the level of a kind of bad cholesterol and a particular blood enzyme. Taken together, they could cause serious heart problems for diabetes patients already prone to cardiovascular disease. A Glaxo executive made the call to squelch the data, internal Glaxo communiqués indicate.
There was worse to come. In 2006, Glaxo provided a meta-analysis — a kind of statistical analysis that combines the results of a number of different studies — to the FDA and the European Medicines Agency that pointed to increased heart risk due to the drug. But the FDA never made the analysis public. Then, in 2007, a clinical researcher at the Cleveland Clinic named Dr. Steven Nissen conducted a meta-analysis very similar to the one Glaxo had conducted the year before. He arrived at roughly the same result, which was in part based on Glaxo's own studies. In a supreme irony, the only reason Nissen obtained those studies was because Glaxo was forced to make them public. That came after Eliot Spitzer, then New York state attorney general, found the pharmaceutical giant had suppressed data that showed children who used its popular anti-anxiety/depression drug Paxil experienced an increase in suicidal tendencies.
"To a great extent, the numbers are the numbers. The Nissen analysis is very similar to our own," wrote one Glaxo consultant in an internal memo requisitioned by the Senate committee.
Publicly, however, Glaxo came out swinging. The company trashed Nissen's analysis and pointed to its own long-term studies as more reliable, much as Roseman did in his testimony before the committee. The first two studies were panned in a New England Journal of Medicine editorial, which said these "industry-sponsored trials do not represent compelling science."
Furthermore, the Glaxo study released specifically to undermine Nissen's, called RECORD, was eviscerated by an FDA scientist who said he found dozens of instances where trial participants suffered heart problems that weren't included in the tally, skewing the results. In most cases, rather than sully the outcome Glaxo hoped for, these participants were simply jettisoned from the trial.
More recent analysis of Avandia by the FDA indicates that as many as 100,000 heart attacks were caused by the drug. Its use was severely restricted by the FDA in September, and it was banned entirely in Europe. Roseman maintains that the risk of heart attack with Avandia is "statistically insignificant."
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