Wednesday, December 17, 2008

And Why Can't We Trust Drug Companies?

Because apparently, they reside somewhere near cigarette manufacturers along the moral compass:

Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

One article was published as an “Editors’ Choice” feature in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after a big federal study called the Women’s Health Initiative linked Wyeth’s Prempro, a combination of estrogen and progestin, to breast cancer. The May 2003 article said there was “no definitive evidence” that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.

At the peak of hormone therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal finding, sales of the hormone drugs plummeted.

The drugs, which contain cancer warnings on the label, are still approved to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.

The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

Wyeth hired a "medical communications company" called DesignWrite, a company that apparently provides these sorts of ghost-written articles. As you can probably figure out, Wyeth is not paying for a ghostwriter to write an article that provides an objective assessment of outcomes regarding use of their drugs; they view these articles as promotional material, so the fact that some iffy studies can make their way into the citations should not be a huge surprise. This isn't the first time this sort of thing has come to light, as Merck took heat earlier this year in the Journal of the American Medical Association for having cobbled together ghostwritten articles to promote Vioxx, a drug that was pulled from the market in 2004 after revelations of its negative side effects. But amazingly, hiring publishing firms whose job it is to contact doctors who are willing to be paid to put their names to things they didn't actually write, is common practice in the medical publishing industry. Wyeth is getting special attention only for the audacity of its approach, not for the mere fact that it utilizes ghostwriters. Everyone does that.

That sort of thing pales in comparison to this example of corporate bad behavior though:

A major pharmaceutical firm funneled kickbacks to Texas health officials, distributed false marketing materials and deployed phony advocacy groups to get its top-dollar schizophrenia drug prescribed to low-income Texans, the state alleges in a new filing in a major fraud lawsuit.

The records in the civil suit allege that Janssen Pharmaceuticals defrauded the state of Texas repeatedly over the last decade to secure a spot for the drug, Risperdal, on the state's Medicaid preferred drug list and on controversial medical protocols that determine which drugs are given to adults and children in state custody.

Texas has spent millions of state Medicaid dollars on the drug, which some recent studies show performs no better than cheap generics, and can lead to diabetes and excessive weight gain, particularly in children.

Janssen officials "targeted Texas Medicaid with their sophisticated and fraudulent marketing scheme," the attorney general's office writes in the filing.

Similar allegations of influence-seeking by drug companies have become increasingly common in recent years, but some watchdogs say the Texas case against Janssen, a subsidiary of Johnson & Johnson, stands out.

"It's standard practice in the industry to influence a few key decision-makers," said Allen Jones, a Pennsylvania whistle-blower who brought the Janssen case to the attention of Texas authorities. "But this is perhaps the most transparent example I have seen."

Although Janssen also used the ubiquitous ghostwritten article:

The state's lawsuit accuses Janssen of getting Risperdal on Texas' list of preferred Medicaid drugs by distributing marketing tools disguised as scientific research: statistically insignificant studies, ghostwritten publications, and "independent" articles that were nothing of the kind.

The company paid third-party contractors and nonprofit groups to promote Risperdal, the state contends, to give state mental health officials and lawmakers the perception that the drug had widespread support. And it had a hand in so-called unbiased research, the suit alleges, providing scientists funding, consulting fees, extravagant meals and travel that compromised their objectivity.

In the mid-1990s, when Texas began designing prescription drug protocols for adults and children in state custody, Janssen provided "substantial funding" and played a role in the protocols' "adoption, revision, promotion, dissemination and implementation," the suit says.

Janssen used Texas' mental health officials as "pitchmen," the suit alleges, "providing them with trips, perks, travel expenses, honoraria and other payments" to get them to promote the drug plan to other states. Risperdal appeared on the children's list – which was never implemented – for eight years before the drug was ever FDA approved for use in juveniles.

In other words, Janssen handed money out to anybody who could in anyway influence the adoption of these drugs by Texas and other state medicaid agencies. As the article reports, officials are "investigation" the possibility of criminal charges against some of these state officials and researchers. I would say though that a conviction in the court of public opinion on charges of absent ethical standards, is also warranted.

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