 |
 |
 |
|
|
Home Page >>
News Articles >> Avandia Maker Cited by the FDA
Avandia Maker Cited by the FDA
|
| April 15, 2008. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: In what appears to be an epidemic amongst drug manufacturers, the US Food and Drug Administration (FDA) has taken Avandia maker GlaxoSmithKline to task for withholding information about the drug long suspected of harboring a higher risk of heart attack than patients on other diabetes drugs.
A stern warning letter was forwarded to Glaxo on March 25th, and posted to the FDA web site one week ago. A spokesperson for the manufacturer chalked up the oversight to "inadvertent omissions."
"However, that's not how the FDA saw it, calling the violations "serious" and ordering the company to take prompt action.
According to various reports, the FDA commenced an inspection of Glaxo's records in August of last year in an effort to determine if the manufacturer was duly reporting all Avandia data in full. In sum, it found Glaxo sorely lacking. As a result of the FDA sleuthing of records covering the period 2001 to 2007, Glaxo was found to have withheld from the FDA the initiation of nine clinical studies. What's more, it was determined that Glaxo failed to update the federal drug agency as to the progress of more than a dozen other studies.
This sounds eerily similar to other, well-publicized transgressions on the part of other drug makers. Bayer AG was called to the carpet for withholding an important study concerning Trasylol in 2006, and the dynamic duo of Merck and Schering-Plough were sent behind the barn after allegedly delaying, for two years, the release of ENHANCE, a clinical trial that showed unfavorable outcomes concerning cholesterol drugs Zetia and Vytorin.
Similar explanations, ranging from unfortunate oversight to time needed to crunch the data, were offered. However, critics have accused drug manufacturers as variously, and deliberately withholding information in an effort to hide negatives that could impact sales. Fines or even lawsuits originating with the drugs in question might pale in comparison to profits earned.
A spokesperson for GlaxoSmithKline revealed that long before the warning letter was issued on March 25th of this year, the FDA had the missing information in hand by September, and before the agency made its decision to recommend that a black box warning be added to the Avandia label.
However, it should be noted that the missing data landed at the FDA's door one month after it began inspecting Glaxo records. Had the FDA not taken the initiative to undertake the inspection, one has to wonder how much longer the transgression would have continued, if it ever would have been resolved at all?
Industry watchdogs will view this as further proof that drug manufacturers are not capable of policing themselves, and that patient care is compromised in the absence of a drug regulator with sufficient teeth, and resources to keep a close eye on everybody, including regular, surprise inspections.
The FDA says that it relies on drug companies to regularly report on clinical trials, so that it can spot potential safety problems with drugs. However, at the end of the day, with all data in hand the FDA stands by its earlier stance that in its view, the evidence regarding increased risk of heart attack inherent with Avandia, is inconclusive.
It has been reported that Glaxo dropped the ball in some administrative requirements pertaining to the reporting of post-marketing studies, but is moving to rectify the problem. A spokesperson for the company stressed that relevant staff are being trained to know what, when and how to report various data and information required by the FDA.
It has been said that the FDA issues a few dozen warning letters each year to various drug companies for various transgressions. The drug companies at the receiving end of the trip behind the tool shed usually comply after the fact. However, yet to be determined, or explained is why such basic reporting practices and protocols are breached in the first place.
As an aside, every parent knows that a child with a failing grade on the report card will not willingly volunteer that report card. The parent has to ask for it...
Avandia was, at one time a hugely popular drug for the treatment of Type 2 Diabetes. However, various studies have found that Avandia poses a risk of cardiovascular complication, including heart attack, heart failure and stroke, as well as fluid retention and weight gain. The Glaxo drug has also been implicated in bone fractures in women, and was recently linked to osteoporosis.
Sales of Avandia have plummeted. Last year a report by the Senate Finance Committee stated that an analysis conducted by the FDA found that 83,000 individuals have suffered heart attacks as a result of taking Avandia.
Keep that fact in mind, together with the FDA's own stance that evidence related to Avandia's risks are 'inconclusive', and the failure of GlaxoSmithKline to release post-marketing trial data in a timely fashion, when you call your Avandia lawyer.
Search 10,000 recent
cases and settlements
Lawsuits:
Services:
© 2001-2008 Online Legal Marketing Ltd. All rights reserved.
