Big Pharma would very much like to ignore side effects of its medications. The big Vioxx/Merck/FDA scandal rocked profit margins and stock prices. Now there is another one brewing, with predictable results: the sudden appearance of smear merchants, deniers, and messenger killers. The drug is Avandia, made by Glaxo Smith Kline, and it is used for Type II diabetes. Patients who took Avandia were 43% more likely to have a heart attack than those who did not, according to a study from the Cleveland Clinic, published in the New England Journal of Medicine last week.
Today in the Wall Street Journal opinion page, a stock tout at the American Enterprise Institute attempts to blast the top medical journal in the world for publishing the key study in an expedited manner, and tries to create the illusion of some political relationships and motivations.
The piece is entitled Journalistic Malpractice, and would seem to apply much more to itself and not to the New England Journal of Medicine. The author, a Scott Gottlieb, “a physician, is resident fellow at the American Enterprise Institute and was Deputy Commissioner of the FDA from 2005-2007,” says, “America’s medical journals are becoming no better than tabloids.”
I won’t go through the many epithets, inuendos, charges, ridicule, and non-scientific blather in the piece, aside from this beaut:
“A few heart events either way might have changed the study’s findings.”
I can hardly think of a scientific study in which this kind of statement would not be true. This sentence betrays such a misconception of the science of the study as to render Dr. Gottlieb’s opinions worthless.
Meanwhile, Dr. Gottlieb has some credibility problems. Firstly, it appears that he went to medical school for purposes other than preparing himself for a career of taking care of patients. Secondly, his experience with medical journals,
I have worked on the staff of two leading medical journals, the British Medical Journal and the Journal of the American Medical Association.
is not exactly what it might seem. Take a look at this piece on Dr. Gottlieb’s appointment to the FDA, which tells about his journal experience; notice why he might have some antipathy towards the NEJM:
Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors.
Now Gottlieb holds the No. 2 job at the Food and Drug Administration (FDA), the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.
Wall Street likes the appointment of Gottlieb, 33, who believes in faster drug approval and fewer news-release warnings to the public about potential side effects of drugs.
But some medical experts are shocked by his July 29 appointment, coming at a time when the public is increasingly concerned about the safety of popular medicines. In addition, the federal government has just begun scrutinizing the growing financial ties between Wall Street firms and doctors researching new drugs.
Gottlieb’s new job “further impedes the independence of the FDA,” said Dr. Jerome Kassirer, former editor of The New England Journal of Medicine. “Gottlieb has an orientation which belies the goal of the FDA.”
“I’ve never heard of anything like this,” said Merrill Goozner, a director at the liberal Center for Science in the Public Interest….
A half-dozen current or former officials at the FDA say they do not know of anyone from Wall Street moving directly into such a high-level job at the agency.
Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May:
“Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38%. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, ‘Three Biotech Stocks To Buy Now.’ ”
Gottlieb was an analyst for a Wall Street investment firm before going to Mt. Sinai School of Medicine in New York. He earned a medical degree in 1999, then did an internal-medicine residency. From 2003 until a few weeks ago, he saw patients during weekend shifts two or three times a month at Stamford Hospital in Stamford, Conn., he said.
Since becoming a physician, he has worn many hats. From 2000 to 2002, Gottlieb wrote the Gilder Biotech Report, an investment newsletter, reporting on potential FDA decisions, drug and biotech developments. He also worked as a staff writer for the British Medical Journal.
In 2003, he was a full-time resident scholar working on FDA policy issues at Washington, D.C.’s most formidable conservative think tank, the American Enterprise Institute (AEI).
Along the way, he became a leading proponent of doctors increasing their income by selling their understanding of drugs and the federal regulatory process to stock analysts and investment firms — “Moving your Career from Main Street to Wall Street,” as Gottlieb wrote in an investment column in the American Medical Association newsletter.
Bizarre FDA rules allow companies to hide clinical information practically in perpetuity. Something needs to change,” he wrote in the Gilder Biotech newsletter in 2002.
“The FDA could and should release data contained in a company’s (FDA) filings at each stage in the process. … Why shouldn’t markets know what bureaucrats and insiders do?”
Kassirer, the former editor of The New England Journal of Medicine, said early release of clinical-trial information “strikes me as potentially good for investors but bad for the validity of clinical research.”
“Releasing data early could result in premature and erroneous conclusions about the drug or device being tested, premature ending of clinical trials and even inappropriate enrollment of patients,” he said.
His performance at the FDA prompted a comparison with the infamous Mike Brown, of FEMA/Katrina fame.
Behind the scenes, however, Gottlieb has shown an interest in precisely those kinds of [scientific and medical] deliberations. One instance took place on Sept. 15, when the FDA decided to stop the trial of a drug for multiple sclerosis during which three people had developed an unusual disorder in which their bodies eliminated their blood platelets and one died of intracerebral bleeding as a result. In an e-mail obtained by Time, Gottlieb speculated that the complication might have been the result of the disease and not the drug. “Just seems like an overreaction to place a clinical hold” on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication “seems very clearly a drug-related event.” Two days prior, when word broke that the FDA had sent a “non-approvable” letter to Pfizer Inc., formally rejecting its Oporia drug for osteoporosis, senior officials at the FDA’s Center for Drug Evaluation and Research received copies of an e-mail from Gottlieb expressing his surprise that what he thought would be a routine approval had been turned down. Gottlieb asked for an explanation.
Gottlieb was part of the Bush adminstrations drive to politicize all levels of the government:
A second method of political control has been simply to redefine civil service jobs as political jobs, or to create new political slots. At the FDA, the post of deputy commissioner for medical and scientific affairs was created for Dr. Scott Gottlieb in July 2005. Hiring Gottlieb gave a free-market ideologue direct authority over drug review and safety. The choice of Gottlieb, who had served as an FDA staffer, was particularly infuriating to career staffers at the FDA’s Center for Drug Evaluation and Research because Gottlieb, a physician in his mid-30s, had little government experience and none running a large organization. Most recently he had been editor of the Forbes/Gottlieb Medical Technology Report, where he advised readers on how to profit from his insider’s view of the FDA.
Besides not mentioning these issues, Dr. Gottlieb fails to mention that the politics of this Avandia medication are actually within the FDA:
U.S. Sen. Charles Grassley (R-Iowa) complained that the Food and Drug Administration was aware months ago of potential heart risks with Avandia and failed to act on an internal recommendation that the drug receive a black box warning, the agency’s strongest warning label.
Translation: the scientific staff made its recommendation, but some political appointee of the Bush administration put the kibosh on it.
Furthermore, Dr. Gottlieb seems to have had some previous hand in the approval process for drugs for Type II diabetes. What sort of conflict of interest do we have here?
Dr. Gottlieb, further, does not disclose that he has issues with the author of the Avandia study, Dr. Steven Nissen of the Cleveland Clinic. The two men, in fact, appeared on the same program:
Dr. Nissen starts at the top.
“For years, we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies,” he says.
“Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict,” Dr. Nissen says. “In his role as director of the National Cancer Institute, Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict.”
Dr. Gottlieb is not happy.
“Even worse, the administration appointed Scott Gottlieb as deputy commissioner,” Dr. Nissen says. “He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter. Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development. So while the American people worry about the safety of drugs, the top FDA leadership tells us we need faster drug approval.”
Dr. Gottlieb lives in a glass house. His sympathies lie with Wall Street and not with protecting the public. He and the Wall Street Journal can publish whatever they wish, but they would do well to divulge his conflicts of interest and track record. He is a stock tout, a political operator, and not a credible critic of the New England Journal of Medicine, nor of the work of Dr. Steve Nissen.