Kudos to a Couple of Pharmaceutical Whistleblowers!

Two private citizens, employees of Physiotherapy Associates, Inc., will receive almost $3 million dollars for blowing the whistle on Physiotherapy and Kalamazoo, Mich. based Stryker Corporation. (Physiotherapy is the former outpatient therapy division of Stryker.)

Stryker and Physiotherapy will pay the United States a $16.6 million settlement to resolve allegations that Memphis based Physiotherapy submitted false claims for services to Medicare, Tennessee Medicaid programs, and the DoD's TRICARE program which they falsely billed as one-on-one services and which they additionally double-billed for.

The Physiotherapy whistleblowers, Kerry Deering and Wendy Whitcomb, filed two successful qui tam suits. Under the whistleblower provisions of the False Claims Act, the whistleblowers receive a portion of the proceeds of a settlement or judgement awarded against a defendant.

Chalk one up for a couple of Good Guys!

Read more here.

I'll Take Zits, and a Loud Blow with a Big Whistle

There's nothing remotely funny about the findings of Dr. Sarah Bailey at the University of Bath regarding Roche pharmaceutical's acne medication Roaccutane, but "I'll take zits" does come to mind.

Dr. Bailey's research shows how Roaccutane, (Accutane in the US) an acne drug, which is similar structurally to vitamin A, could disrupt seotonin levels in the brain leading to feelings of severe despair in an already vulnerable population of teenagers and young adults. Despair that could turn deadly.

From Dr. Bailey: "In the brain, it [serotonin] is thought to play an important role in the regulation of a range of behaviours, such as aggression, anger and sleep. Low levels of serotonin have been linked to depression, as well as bipolar and anxiety disorders. Many medications aimed at treating depression seek to increase levels of serotonin to help overcome these problems. Our findings suggest that Roaccutane might disrupt the way serotonin is produced and made available to the cells."

What do the folks at Roche have to say? They prefer to talk about a glass they consider to be well over half full, rather than dwell on the negative and even deadly side effects they KNOW are associated with their drug. According to a Roche spokesman, over 13 million patients worldwide have been treated with Roaccutane, a drug which "...has revolutionised the management of severe acne."

Indeed. Roaccutane (Accutane) has been linked to over 200 deaths in the US and at least 15 in the UK, prompting parents who've lost their children to demand that the drug be taken off the market.

Back to Roche's eloquent spokesperson:
"Unfortunately, severe acne can cause some sufferers to become depressed and can also affect their mood and self esteem. This is why the information provided with Roaccutane carries a warning that some patients may experience mood changes, including an increase in depression."

In other words..."don't say we didn't warn you." Thanks. I'll take the zits. And hope I hear a whistle blowing, 'cuz this just ain't right...being a teenager is tough enough without worrying that your zit meds might be killing you.

You can read more here.

UCLA blows the whistle on pharmaceutical ads in medical

Check out the Feb. 15 issue of the Canadian Medical Association Journal for a UCLA study reviewing pharmaceutical advertising validity and funding. They found that almost ONE THIRD of the drug ads contained NO references for the medical claims they made. Researchers also examined the funding sources of the research cited in the ads and concluded that most of the "original research" used to support the ads claims was in fact sponsored by pharmaceutical companies.

According to the study, the FDA does "screen" drug ads, but because of the huge volume of ads they are not able to "check" many of the ads. (In 2002, for example, the FDA "screened" more than 34,000 ads for drugs.)

The investigators looked at 438 ads from 10 American medical journals, along with a random sample of 400 references in journal articles from the same publications.

Here's what they found.
Out of 438 ads, 126 included NO references to support the medical claims they made. In the ads that did include a reference, over half cited other journal articles, and 19 percent cited "data-on-file" which is simply an unpublished company document.

When the researchers dug a little deeper, to see if they could actually get their hands on the referenced documents, they could only obtain 20 percent of the "data-on-file" documents. Repeated requests to the pharmaceutical companies yielded 37 out of 88 requests for the data-on-file, however over half of these responses were that "...due to 'company policy' or the proprietary nature of the data, the information requested would not be provided."

"We found that almost one-third of the pharmaceutical ads offered no references at all to support medical claims. In addition, most of the data-on-file documents in support of the medical claims were not available from the drug companies," said Dr. David Schriger, study author and professor of Emergency Medicine at UCLA.

Journal articles fared better--99 percent of the referenced documents were available to the researchers.

What about the funding of these pharmacuetical ads?
Out of 294 ads that claimed to rely on original research, 58 percent were sponsored by a pharmaceutical company or its authors were affiliated with the funding pharmaceutical company. Nineteen percent were government or charity funded, and 23 percent INCLUDED NO FUNDING STATEMENT WHATSOEVER.

Go here to read more.