Off-Label Drug End Run Causes Personal Injuries and Wrongful Deaths
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Off-Label Drug End Run Causes Personal Injuries and Wrongful Deaths

Monday, June 09, 2008By Richard Alexander

Kudos to Evelyn Pringle of the Media Monitors Network for an excellent case study of how drug companies promote profits by paying for research supporting off-label uses for products that cause personal injuries and wrongful deaths -   "Just What Kids Need - Sparlon - Another ADHD Drug" (March 2006).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% of drug treated subjects at final follow-up were "much" or "very much" improved clinically, 52% 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.

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