Tag Archives: pharmaceutical companies

Promoting off-label use is too profitable to ignore

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

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.

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Photo by sean dreilinger via Flickr.

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

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

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.
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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

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-scale

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.