Rise, fall of two St. Louis pharma companies
Filed under: Health journalism, Hot Health Headline
Midwest Health Journalism Program fellow Jim Doyle, a reporter at the St. Louis Post-Dispatch, tells the story of Forest Pharmaceuticals (a subsidiary of Forest Laboratories), which has been accused by federal regulators of sketchy marketing practices, primarily involving its antidepressants Celexa and Lexapro and unapproved pediatric use. The company has pleaded guilty to federal criminal charges and agreed to pay $300 million in criminal and civil penalties, Doyle reports.
Armed with the breaking news, Dolye then goes deeper, finds the company’s local roots, charts its rise and tries to pinpoint where it went wrong. It’s the same formula he used for his story on another imploding local drug-maker, KV Pharmaceuticals, earlier this year.
U. of Michigan president sits on pharma board
On The New York Times Prescriptions blog, Duff Wilson reports that while her school has taken a lead in limiting conflicts of interest, University of Michigan President Mary Sue Coleman herself sits on the board of Johnson & Johnson, a post which earns her $229,978 each year. Her defense is that she’s openly disclosed the relationship, and that the world of pharma and that of university administration rarely intersect.
Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said.
“The same is true at J&J,” she added. “There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.”
It’s not uncommon for university presidents to sit on corporate boards, Wilson found, but it appears that pharmaceutical companies are a special case given the major role universities play in medical research and health care delivery.
Thomas Donaldson, a corporate governance expert and professor of business ethics at the Wharton School of the University of Pennsylvania, reviewed the case on Monday for The Times. He said many university presidents serve on corporate boards, but biomedical company boards pose special issues because of the possible ties to university research and medical schools.
“Because of the role of research and also the entrepreneurial interest that lies behind a lot of modern advances in medicine, this is a very difficult issue,” Professor Donaldson said in a telephone interview. “We’ve been aware for decades really that this potential for conflict of interest exists, but we haven’t as a moral community or even inside universities gotten our arms around it yet.”
State NAMI chapters got pharma money too
Wall Street Journal health blogger Katherine Hobson writes that, according to an investigation by Sen. Chuck Grassley, state chapters of the National Alliance of Mental Illness received millions of dollars in contributions from pharmaceutical manufacturers in a five-year period. This follows an Oct. 2009 New York Times report which found that “drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.”
The group’s state chapters – except for Alabama, Arizona, Connecticut and Hawaii – reported their own donations to Grassley, he wrote in a letter to NAMI’s executive director and president of the board of directors. According to the letter, the California chapter received $632,000 in contributions between January 2005 and October 2009, the most of any state. Ohio NAMI received $623,000 and New York NAMI $448,000. The top ten states received a total of $3.84 million.
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.
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