How the pharma research ’sausage’ is made
Filed under: Health journalism, Hot Health Headline, Public records, Studies
Reporting on Health’s William Heisel has posted the latest installment in his series highlighting the spiciest entries in the Drug Industry Document Archive, this time focusing on the cold mechanics of the drug industry’s research paper assembly line, and its intimate relationship with pharmaceutical marketing.
Again, Heisel focuses on the deposition of Wyeth ghostwriter Karen Mittleman and related documents and memorandums. He lists the names of some key ghostwriters to look out for, then details a number of specific cases when production and marketing concerns clearly outweighed science, at least as far as the pharmaceutical manufacturers were concerned.
Promoting off-label use is too profitable to ignore
Filed under: Government, Hot Health Headline, Pharmaceuticals
In a special report titled “Big Pharma’s Crime Spree,” David Evans of Bloomberg Markets writes that pharmaceutical companies continue to promote drugs for uses not approved by the FDA, despite paying billions of dollars in fines and penalties.
Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in penalties after promoting drugs for uses not approved by the FDA. This unlawful behavior may not end until prosecutors force a drugmaker into bankruptcy.
Even as prosecutors extract promises from the companies’ lawyers to never market off-label uses again, the pharmaceutical giants are doing just that because the revenue is so much greater than the penalties.
Harvard professor Jerry Avorn says “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”
Evans breaks down the numbers to show why drugmakers see off-label prescribing as so essential. He also talks to a former “medical liaison” with Warner-Lambert who grew concerned about his own role in pushing potentially harmful uses of drugs and filed a lawsuit against the company.
He writes that “prosecutors and judges have been unwilling to use the ultimate sanction – a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.” That, as one prosecuter says, is “potentially a death sentence for a drug company.”
They gave us Part D, now protect it from reform
Filed under: Conflicts of interest, Government, Health care reform, Health journalism, Pharmaceuticals
ProPublica’s Olga Pierce reports that at least 25 of the folks who helped push through pharma-friendly Medicare Part D six years ago are back as lobbyists,and this time they’re fighting to make sure the plan isn’t reduced by reform-related budget cuts.
Pierce’s piece can be divided into three sections, each illuminating and alarming in its own way: How this crew of insiders pushed the envelope to force through Part D in 2003 (Hint: A legendary abuse of the legislative process helped), how they’ve returned and who’s paying them (see a nifty chart of those connections here), and what they’re up to this time around (more of the same, only this time they’re wealthier).
Alongside Pierce’s story, she and ProPublica have launched “Eye on the Health Care Reform,” a feature in which Pierce will keep up with the reform effort’s legislative journey.
Drug maker sues Pittsburgh Post-Gazette
Filed under: Health journalism, Pharmaceuticals, Public records
Mylan Inc., the world’s third-largest manufacturer of generic pharmaceuticals, has sued the Pittsburgh Post-Gazette and reporters Len Boselovic and Patricia Sabatini over a July 26, 2009, story in which the reporters alleged that Mylan employees at a West Virginia facility had been systematically ignoring automatically generated warnings that the drugs being manufactured might not meet federal specifications. The story cited “a confidential internal report obtained by the Pittsburgh Post-Gazette.”
In the suit, Mylan alleges that the Post-Gazette report misrepresented a confidential report and make it seem like the plant had serious quality control and regulatory issues. The drug maker seeks the return of those internal documents (and any others the paper might have), and compensatory damages from those who benefited from what the company claims were improperly obtained documents. See Mylan’s press release.
According to Post-Gazette reporter Teresa Lindeman, an FDA review spurred by the story found that the company had taken sufficient steps to correct the matter. The FDA plans no further action in the case.
University’s ties to testosterone therapy questioned
Filed under: Conflicts of interest, Hot Health Headline
When it comes to sketchy medicine, female hormone therapies have company. According to reporter John Fauber of the Milwaukee Journal Sentinel, the fast-growing field of testosterone therapy is “based largely on iffy science, promotion, manipulation and conflicts of interest,” much of which originated at the University of Wisconsin.
Fauber found the questionable ties during an investigation of company-funded UW courses that count as continuing education credits for local physicians. Despite the lack of rigorous research into testosterone therapy’s effects, UW courses (with material created in part by drug company contractors and involving studies authored by doctors with drug company ties) and other like them have helped push testosterone therapies, especially Solvay’s AndroGel, to millions of American males. In his extensively researched piece, Fauber takes on not only local conflicts of interest, but also the male hormone replacement and anti-aging movement.
Med school conflict of interest policies rated
Filed under: Hot Health Headline, Pharmaceuticals, Studies, Tools
The American Medical Student Association released a 2009 version of their PharmFreeScorecard, evaluating 149 U.S. medical schools based on their stated conflict-of-interest policies. According to the executive summary, 21 percent of schools improved their policies in the last year, with 16 more schools scoring an A or B in 2009.
AMSA rates policies in fields such as scholarships, continuing medical education, purchasing, gifts and samples, curriculum, consulting, speaking and disclosure and combines them to determine a school’s overall grade. The association handed out 9 As, 36 Bs, 18 Cs, 17 Ds and 35Fs, with 27 schools still pending or otherwise in the process of changing their regulations.
Drug companies paid for mock journals
Filed under: Conflicts of interest, Hot Health Headline
According to TheScientist.com’s Bob Grant, Merck paid health publisher Elsevier to publish six journals earlier this decade, a relationship that was not disclosed in the professional-looking publications. Grant found two copies of the fishy journals, both of which bore Elsevier’s Excerpta Medica imprint.
The allegations involve the Australasian Journal of Bone and Joint Medicine, a publication paid for by pharmaceutical company Merck that amounted to a compendium of reprinted scientific articles and one-source reviews, most of which presented data favorable to Merck’s products.
The publications were put out by Elsevier’s Australia office and , in a statement, Michael Hansen, CEO of Elsevier’s Health Sciences Division, says, “This was an unacceptable practice, and we regret that it took place.”
When confronted with the questionable publishing practices surrounding the Australasian Journal of Bone and Joint Medicine last week, Elsevier indicated that it had no plans of looking into the matter further, but that decision has apparently been reversed.
“We are currently conducting an internal review but believe this was an isolated practice from a past period in time,” Hansen continued in the Elsevier statement. “It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again.”
Grant reports that Elsevier has refused to name the other drug companies that paid for mock journals.
Marketing treats risk factors as diseases
Maryann Napoli writes in the American Journal of Nursing that “in the name of prevention, millions of Americans have accepted the idea that it’s reasonable to treat a risk factor such as bone loss or high cholesterol as if it were a disease.”
Napoli zeroes in on low bone density, a risk factor for hip fractures that, through careful marketing, promotion of regular screenings and celebrity endorsements — all funded by a major pharmaceutical corporation — has been inflated into a disease that has sold millions of dollars worth of bone-density drugs. All this despite the fact that the affect of the drugs in prevention of hip fractures is minimal at best.
According to Napoli, “consumer advocate Barbara Mintzes summed up the situation nicely: “Bone mineral density testing is a poor predictor of future fractures but an excellent predictor of start of drug use.”"
More people should question the wisdom of starting long-term drug therapy. Often the magnitude of the risk factor has been overestimated, or the danger of the disease itself exaggerated, by people trying to sell you something —like a drug you must take for the rest of your life.
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Health Journalism 2010, AHCJ's annual conference, features a world-class program with story ideas, sources, stronger reporting skills, chances to meet newsmakers and network with other journalists.
- Health and education: Covering these intersecting beats
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- Health reporting resources for journalists on state and local government beats
- Shortened Lives: How location, lifestyle affect health
- Covering a complex story for the long haul
- Aging in the 21st Century: Presentations and tip sheets
- AHCJ calls for better information from Joint Commission Web site
