FDA Tells GSK to stop sending out misleading info to health professionals

Read the FDA WARNING LETTER TO GSK.



According to the FDA, GlaxoSmithKline has sent out letters promoting Tykerb, which "...omit and minimize the most serious risk information" and "...selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug. Most important, the letters minimize the important risk of decreased left ventricular ejection fraction," which is a measurement of the amount of blood pumped out of one section of the heart.



Tykerb (generic name lapatinib) was approved by the FDA last March as a once-a-day pill for certain patients with advanced breast cancer.


The FDA's six-page warning letter to GSK also says that they failed to warn patients about liver problems and pregnancy. Glaxo was asked to STOP sending the letters, and to stop sending out any information like it, AND to send corrected information to every health professional who received the original, misleading letter.
GSK says they're taking the FDA's letter seriously and they'll work with them to address their concerns. Wow, big of them.
Hopefully someone on the inside will blow the whistle on this one. Will GSK send out corrected information before it's too late?

This is Your Brain on Drug Industry Money

Read the whole story here. Dr. Carlat tells all, or at least most.

D'you think the devil made him do it? Or the money?

Dr. Daniel Carlat made $30,000 spinning Wyeth's Effexor XR to other doctors. Wyeth gave him slides, info, and paid for him to go to a speaker's seminar. Carlat made $500 for every "Lunch and Learn" talk he gave around town...$750 if he had to drive an hour to do it. Wyeth flew him around to other places, wined and dined him, and basically pimped him out. Now he says he maybe oughtn't have done it. But he kept the $30,000. His story is worth reading. Wyeth says they follow "guidelines"...those of "the industry" and their own, when it comes to compensating docs for spinning, er, speaking fees.

Any Whistleblowers know more?

FDA Probing Safety of Advair and Serevent for Children

Read more HERE.

There seem to be an alarming number of opportunities for GlaxoSmithKline pharmaceutical whistleblowers. Today the concern is all about potential fatal side effects of Advair and Serevent in children who take the drugs to treat asthma.

Five deaths, and four cases of "adverse events" were reported in children under 16 since March 2006, when GSK was granted pediatric exclusivity. Just five months earlier, in March of 2005, the FDA issued a warning that drugs containing long-acting beta agonists (such as Advair) can trigger severe asthma attacks and even possibly death.

GSK isn't worried. They said they've provided clinical data that "proves" the products are safe, and they're confident that the benefits outweigh the risk. Advair is a huge seller for GSK, with sales of $6.8M worldwide.

Whistleblower Seeks Her Fair Share

Read more HERE.

CANTON – Antoinette Menapace helped the federal government uncover millions of dollars in health-care fraud.

She isn’t a doctor, a lawyer or a cop. She’s a grandmother and former medical coder who didn’t think the numbers added up.

Almost two years ago, she filed a lawsuit against her former employer, Dr. Mohammed Aiti, claiming he and other doctors at Premier Medical Group were billing government and private insurance companies for unnecessary heart-related tests.

The FBI and federal prosecutors took up the case, which led to Aiti’s conviction, the end of his medical career and the forfeiture of close to $1.9 million. Aiti is to be sentenced Jan. 10. He faces up to five years in prison and a $250,000 fine.

Psychchiatric Warnings on Flu Drugs Tamiflu and Relenza?

An FDA panel is reviewing recommendations that psychiatric warnings be added to the labels of two flu drugs, Roche's Tamiflu and GlaxoSmithKline's Relenza.

The label warnings on Tamiflu would include "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients." The Relenxa box label would be updated to include: "reports of hallucinations, delirium and abnormal behavior" seen in some patients taking the drug.

The adverse events have occurred. The FDA isn't sure whether the drugs are the cause, or a disease, or a combination of the two. Roche and GSK say it's not the drugs.
Wonder if any whistles will blow on this one?

The summary document for advisory meeting can be found right here: