Tuesday, May 22, 2007

PharmaGossip Has Great Clip on How Medications Lead to Heart Disease

The New England Medical Journal bravely published an article showing : Thanks PG :)
"Oh dear!

It looks like a wheel has fallen off the "glitazone bandwagon"!

GlaxoSmithKline, Europe's biggest drug-maker, was last night racing to shore up confidence in one of its most important medicines after a study in a respected US journal suggested that it dramatically increased the risks of having a heart attack.

The drug in question, Avandia, is taken by millions of Americans and others around the world who suffer from diabetes.

It contributed £414m to GSK's sales in the first three months of this year.

A study published by the New England Journal of Medicine (NEJM) yesterday analysed all the previously published data from studies of Avandia and calculated that taking the drug increases the chance of having a heart attack by 43 per cent.

The increase in the risk of having a fatal heart attack was even higher.

GSK immediately questioned the methodology of the study, which was conducted by Dr. Steven ("Drugslayer") Nissen, a cardiologist at the respected Cleveland Clinic in Ohio - but more than $10bn was wiped off the value of the company in afternoon trading in the US in the wake of the study.

Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, comments about the meta-analysis are most revealing:

"This analysis is just scratching the surface of what may be there. It needs to be taken seriously," said Nathan, who reviewed the paper for the medical journal and has no financial ties to any diabetes drugmakers.

The situation "reflects very badly on the FDA and on Glaxo," Nathan said. "It's the FDA's responsibility to be monitoring this stuff."

But wait! There's more:

The drug "represents a major failure of the drug-use and drug-approval processes in the United States," Drs. Bruce Psaty and Curt Furberg wrote in an editorial in the NEJM.

Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.

When the drug was approved, evidence of its benefits were "at best mixed," wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct involving Vioxx.

Sources: The Indy, Channel 7 Boston"


What bothers me about this, is that the populous continues to take these medications, which ARE NOT TESTED IN LARGE GENERALIZABLE SAMPLES and therefore when they are introduced in LARGE distribution, heart damage is a major side effect. This has been TRUE OF JUST ABOUT EVERY WEIGHT LOSS "MEDICATION."

My Kitty advice is to NOT TAKE ANY weight loss or NEW arthritis medications until AT LEAST A YEAR after their large scale introduction to America. This is similar to how I feel about buying a cool new car. I would never recommend anyone to buy the first year of a new line of cars. It always takes at least a year TO IRON OUT ALL THE BUGS. One of the major problems with the FDA process, is that IT IS STATIC instead of proactive and fluid.

As data comes in on a certain synthetic molecule, then all data should be aggregated and continually analyzed by a team of crack biostatisticans LEAD BY INDEPENDENT PRIMARY INVESTIGATORS. Side effects need to be flagged and spit out to proper officers if they occur at a certain a prior rate overall and for demographic strata, such as kids or older adults or those on other medications and those with chronic diseases.

All models (UNLIKE THE CURRENT FDA PHASE I AND PHASE II TRIALS) SHOULD include all relevant covariates and use adjusted rates of side effects. This has not been done, although I think now, they are starting to do this. Much more on this later... Love and Peace and NO NEW SYNTHETICS


Pharma Giles said...

Good post. I'm so glad you decided not to call it a day, BK...

Dr. BK said...

Thank you so much PG :) You are an inspiration (and template for) alot of my blogging. If you get up the North Americas, let me know - I bet you would be fun to show around :) And if Mr. Giles IS married, it is all good, so am I :) So, Mr. Mack, I don't "Mack" on the male bloggers, I enjoy myself with all of you.

Its all good.

Dr. BK