Glaxo's Legal Bills for Avandia: $3.5 Billion and counting

Image by neofedex via FlickrThere is news that Glaxo  will have fourth-quarter legal costs of $3.5 billion because of investigations into sales practices for certain products and product-liability cases related to Avandia, a diabetes drug.

The company will be putting aside additional monies for other investigations, including one by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products.

The troubles mount for Glaxo, and this report simply shows the costs related to a drug that the FDA has put under the microscope. As recently as 9/23/10, the FDA placed restrictions on the drug.


From the FDA release:

The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

 

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.” Link.

 

More news here.

Why the EU banned Avandia but the FDA Didn't

From Fortune and CNN/Money:


Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here's the rub: The European Union's European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn't the FDA?

For more go here.  http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm?section=money_latest&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+rss%252Fmoney_latest+%2528Latest+News%2529

Georgia News: Avandia in the UK

The diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) is once again in the media spotlight  in the UK, where it has emerged that experts from the UK Commission on Human Medicines (CHM) decided unanimously at the end of July that the drug should be withdrawn.


This recommendation was not made public, however, in line with protocol. It was communicated to the British drug-licensing agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), which instead sent out "Dear doctor" letters reiterating safety information with regard to rosiglitazone from 2007, including a suggestion to consider alternative treatments where appropriate.

http://www.theheart.org/article/1120105.do

En Espanol:


El rosiglitazone de la droga de la diabetes (Avandia, GlaxoSmithKline) es una vez más en los medios ilumina con proyector en el RU, donde ha surgido que expertos de la Comisión del RU en Medicinas Humanas (CHM) decidió unánimemente a fines de julio que la droga debe ser retirada. 

Georgia Avandia: News of Problems in Forums/Chat Rooms as early as 04?

Image by neofedex via Flickr
A new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.

Patients first started questioning whether it was safe to take Avandia given their situation, especially those with congestive heart failure (CHF), in 2003 and 2004, but the drug was still seen as a good alternative for many with type 2 diabetes, notes the report. Negative comments began referencing Avandia risks in 2005 but were more likely to grow out of frustration with weight gain and edema—potential side effects of drugs in the thiazolidinedione (TZD) class.

The tone changed in 2006. Discussions went beyond swelling and weight gain to comparisons with other products shown to lower blood sugar without these risks, such as Eli Lilly/Amylin's Byetta and Merck's Januvia. Chatter about other side effects lit up message boards, as well. Analysis of comments shows patients connected edema to an increased risk of CHF, and some reported increased blood pressure. Anger and frustration grew, as physicians seemed disconnected from the concerns.


More here

Avandia Georgia/Florida: TIDE Letter

Excerpt from the Tide Trial letter:
 
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee

Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.

As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.

As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.

This is the letter that went with the Glaxo letter to others.


http://www.markzamora.com/AvandiaFLA/index.html

Avandia Georgia News

From the NYT: 
Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.

Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.

Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.

“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”


http://www.nytimes.com/2010/08/20/health/policy/20fda.html