Thursday, February 26, 2009

Cockroach News Catches: Paroxetine and Citalopram

For all the news that the Cockroach Catcher finds interesting!

Looks like GlaxoSmithKline PLC (GSK) is in the news again and this time it is not about

In today’s Wall Street Journal:

U.S. Probes Emory Doctor's Glaxo Ties

FEBRUARY 26, 2009, 12:02 A.M. ET

“Federal officials are investigating Emory University to determine if the school misled the National Institutes of Health about its star psychiatrist's lucrative consulting work for big drug makers, people familiar with the matter said.
The probe by the inspector general for the Health and Human Services agency, which investigates fraud in NIH programs, concerns the work of Charles Nemeroff. From 2003 until last year, Dr. Nemeroff served as primary investigator on an NIH-funded research effort to study five GlaxoSmithKline PLC drugs for use as antidepressants. During that time, Dr. Nemeroff also received hundreds of thousands of dollars from Glaxo.
The NIH requires universities to report potential conflicts of interest to the agency and to ensure research is carried out objectively.
Schools that violate those policies could face sanctions, ranging from fines to a freeze on funding. Emory received $251 million in NIH grants last year, more than half of all the Atlanta school's outside research funding.
An Emory investigation of the matter in December concluded that Dr. Nemeroff failed to report more than $800,000 he received from Glaxo from 2000 to 2006. Dr. Nemeroff stepped down as chairman of the psychiatry department and the school said it wouldn't submit any research requests to the NIH involving Dr. Nemeroff for at least two years.”
This bit in the WSJ is worrying:
“Records obtained by Mr. Grassley show that Dr. Nemeroff played a role in a Glaxo program that was established to aggressively promote the British company's top-selling antidepressant, Paxil (Paroxetine).
Glaxo described this "PsychNet" program in an internal 2000 document as "an ideal way for key opinion leaders to influence clinicians...on the benefits of Paxil versus competitors" and to train doctors to "help build Paxil advocacy."
Dr. Nemeroff was listed as one of two speakers at a March 2000 session in Naples, Fla., to train doctors "on the efficacy of Paxil and the PsychNet presentations." Doctors were paid $2,500 per talk and required to sign agreements barring them from saying how much they were paid or sharing materials Glaxo provided.”

Paroxetine has been in the
UK news before now.

But GSK may not be alone and this time it involves the company directly.

In the New York Times:

Drug Maker Is Accused of Fraud

Published: February 25, 2009

The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro (versions of citalopram) for unapproved uses in children and teenagers.

In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.

Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the
Food and Drug Administration only for adults.

Prosecutors said in the complaint:

“Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients.”

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