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[D705]Drug Research And Development
by Richard Alexander, Ric
The report features DuBose Ravenel, MD, a pediatrician with 25 years experience with ADHD children, who testified for the International Center for the Study of Psychiatry and Psychology at the FDA's March 23, 2006 meeting of the Psychopharmacologic Drugs Advisory Committee and blew the whistle on Joseph Biederman's conflict of interest in his research supporting an off-label use for an ADHD drug.

Together Evelyn Pringle and Dr. Ravenel raised ethical questions of Dr. Biederman relationships to a drug companies. Add that to the recent revelations by the New York Times' "Researchers Fail to Reveal Drug Pay" June 8, 2008 and you will see why I recommended in my previous article on this topic that Harvard make a public example of their "payola" faculty by firing them.

Here is what Ms. Pringle wrote in March 2006.

"The pharmaceutical company, Cephalon Inc, is going through the motions of legitimizing the sale of Sparlon for the treatment of ADHD even though its active ingredient, modafinil, has been heavily promoted and sold under the name Provigil, for off-label treatment of ADHD by Cephalon for years.

"Last October, the FDA sent an "approvable" letter to Cephalon for the pediatric use of Sparlon pending a March 23, 2006, meeting of the Psychopharmacologic Drugs Advisory Committee to review the drug's approval.

"Modafinil-based Provigil is currently only approved for narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA. However, it is estimated that half of all Provigil prescriptions are written for off-label use.

"Doctors now prescribe it to treat everything from attention deficit hyperactivity disorder (ADHD) to fatigue associated with multiple sclerosis and depression," according to the November 1, 2004 Business Week Online.

"Cephalon gets nearly half of its $1.2 billion in annual sales from modafinil.

* * *

"With Sparlon's application to FDA approval, Cephalon claimed 3 studies involving more than 600 children aged 6 to 17, found the drug to be more effective than a placebo.

* * *

"Dr DuBose Ravenel, MD, who will testify on behalf of the International Center for the Study of Psychiatry and Psychology at the advisory committee hearing on March 23, makes the point that although "48 were not."

"This is a substantially lower response rate than has been reported for traditional stimulants," the doctor notes.

Dr Dubose Ravenel is a pediatrician with 25 years experience in private practice with a heavy emphasis upon behavioral issues, including diagnosing and managing ADHD.

"In addition, she notes, with regard to potential conflicts of interest, itemized conflicts for each of the Pediatric study's authors are numerous.

"For instance, "Dr. Biederman received research support from 10 companies, serves on speakers' bureaus for 4 companies, and is on advisory boards of 6 companies,"" Dr Dubose Ravenel reveals.

"Other authors have numerous listed conflicts as well she notes.

"In light of recent widely publicized articles showing widespread deceptive practices engaged in by pharmaceutical companies in designing, selective reporting, and interpreting studies," she says, "the large number of pharmaceutical company ties with the authors of the study do not lend confidence to the reader even beyond the aforementioned concerns."

And "thank you" to Dr. Ravenel for reporting on conflicts of interest in drug research investigations. Good job.

Drug company money influences and corrupts research. That is a given.

What is less understood is why drug manufacturers spend billions for research on off-label uses for their products - uses that were never cleared with the FDA when the drug was submitted for approval.

Off-label use allows drug companies to get "through the back door" what they could never, and I mean never, get away with by going directly to the FDA for approval for a new use of a product - what is known today as an off-label use.

You would hope that researchers wouldn't corrupt the commercial experimentation of a new, or off-label, use of a drug to treat children by covering up their consulting fees from Big Pharma. But that's what happened.

More important than what happened is why it happened and at the bottom of all this is a terrible mistake the U.S. has made in allowing the exploitation of off-label use.

The devil is in the details, so here is the story as it has unfolded.

Leading Harvard professors studying off-label uses, the gold mine of the drug industry, have violated National Institute of Health reporting requirements when more than $10,000 has been received from a subject company, according to the New York Times, "Researchers Fail to Reveal Drug Pay" June 8, 2008. http://www.nytimes.com/2008/06/08/us/08conflict.html'em&ex=1213070400&en=9971013dfd33290a&ei=508720say20are%20sorry&st=cse isn't enough.

If Harvard doesn't fire them, it will be complicit in the cover-up.

Throw them off campus. Ring the bell loud and clear that no matter how renown or stellar, if you don't play by the rules, you can't play at all. And the NIH should forever ban them from receiving grants.

Don't throw out the baby with the bath water. Once appropriate punishment has been served, give these researchers a chance to polish their tarnished reputations. Allow them to conduct research under the supervision of a responsible administrator who knows that "veritas," means truth, accuracy, honesty, and uprightness and that it's more than just a motto.

Onward.

Richard Alexander
http://www.alexanderinjury.com
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Richard Alexander has sinced written about articles on various topics from Health, Marketing and Cancer. How Off-Label Drug Research Supports Profits - Ethical Questions of Harvard's Biederman's Drug Research Raised in 2006. Richard Alexander's top article generates over 8100 views. to your Favourites.
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