For Canadian Zyprexa victims…

Eli Lilly must treat Canadian Zyprexa victims the same as American ones, according to a recent press release:

Drug giant Eli Lilly and Company announced last week a $US 690 million offer to settle 5,000 claims emanating from the negative side-effects of Zyprexa, a drug prescribed for the treatment of schizophrenia and conditions such as bipolar disorder.

A class action suit on behalf of those who have suffered negative consequences from Zyprexa, was filed last January in the Supreme Court of British Columbia by the law firm of Poyner Baxter of North Vancouver. The B.C. Zyprexa action alleges a direct link between Zyprexa and diabetes. The Plaintiff, a resident of a home for mentally disabled people, alleges that his use of Zyprexa resulted in diabetes. Options available to this patient for the treatment of the original mental condition are now egregiously limited because of the Zyprexa-induced diabetes. Poyner Baxter will be appearing June 22 before Mr. Justice Stephen F. Kelleher to discuss management of this case in B.C.

But last week, Zyprexa was in the world health headlines, as Eli Lilly announced that $US 690 million would be offered to U.S. claimants. In making the announcement June 9, the company’s chairman and chief executive officer Sidney Taurel, said: “While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors. Our decision to resolve these claims does not change the fact that Zyprexa has and will continue to improve the lives of millions of patients around the world who are suffering from schizophrenia and bipolar disorder.”

There were 6 million prescriptions for Zyprexa in Canada over the 12 months ending October 2003. Total sales in Canada were valued at $223 million in 2002 and over $4 billion worldwide in 2003. Zyprexa has been associated with an increased risk of developing diabetes, hyperglycemia, pancreatitis, ketoacidosis and other injuries. In an October 16, 2003 press release, Eli Lilly disclosed a Health Canada order directing it to include updated information on hyperglycemia and diabetes on the labels of their antipsychotics.

For the rest of the piece, go here. To read the text of the Statement of Claim, go here.

Medical whistleblowers speak out against FDA

EurekaAlert has published a very interesting article about medical whistleblowers speaking out…

The US Food and Drug Administration (FDA) was “the single greatest obstacle to doing anything effective” about Vioxx, said FDA drug safety officer David Graham at an unprecedented roundtable of medical whistleblowers sponsored by the Public Library of Science (PLoS) and the Government Accountability Project.

In comments that echoed his now infamous testimony to the US Senate Finance Committee, Graham said that, “Nearly 60,000 people probably died from that drug. That’s as many of our soldiers that were killed in the Vietnam war [who] died as a result of Vioxx use. And FDA had the opportunity, the responsibility, to stop that and didn’t.”

Graham was one of five high profile medical whistleblowers invited by the medical investigative journalist Jeanne Lenzer to meet together in Washington DC on May 15th 2005 to share their accounts of practices in medicine and medical research that they believe are risking the public’s health or safety. Lenzer’s account of the roundtable, in which she outlines the lessons we can learn from these whistleblowers, is published in the open access international medical journal PLoS Medicine. One of the lessons, says Lenzer, is that “ties between drug regulators and industry may influence new drug approval.” Graham said at the roundtable that the FDA was in “a collaborative relationship” with industry, and that the FDA gets money from drug companies through the Prescription Drug User Fee Act “to approve new drugs and approve them more quickly.” A senior official at the FDA, said Graham, had told him, “industry is our client.”

“The pharma-FDA complex has to be dismantled,” he said, “and the American people have to insist on that, otherwise we’re going to have disasters like Vioxx that happen in the future.”

If the FDA had been more objective, could many of today’s class action suits have been avoided? Hm…

Zyprexa the #5 drug of 2004

PharmaLive.com’s list of 2004’s best-selling medicines (worldwide) included Zyprexa, which is the subject of a current class action suit.

Here’s the list, which I summarized from the article:

1. Lipitor ($10.86 billion - Pfizer) - #1 for the last 3 years - first Rx drug to top $10 billion in a year
2. Zocor ($5.2 billion - Merck)
3. Advair ($4.5 billion - GlaxoSmithKline)
4. Norvasc ($4.46 billion - Pfizer)
5. Zyprexa ($4.42 billion - Eli Lilly and Co.)
6. Nexium ($3.89 billion - AstraZeneca)
7. Procrit ($3.59 billion - Johnson & Johnson)
8. Zoloft ($3.36 billion - Pfizer)
9. Effexor ($3.35 billion - Wyeth) - newcomer to top 10 list
10. Plavix ($3.33 billion - Myers Squibb Co.) - newcomer to top 10 list

Interesting how the suit, which was filed just over a year ago (last April, I think) hasn’t really had an impact on overall sales.

FDA’s MedWatch

If you’re at all concerned about Vioxx, Bextra, Celebrex, Accutane, or Zyprexa, you may want to bookmark the FDA’s MedWatch page, which is “your Internet gateway for timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration.”

MedWatch is “The FDA Safety Information and Adverse Event Reporting Program,” and it contains a wealth of information and updates on adverse reactions to various medications, devices, and so forth.

For instance, today the front page includes recently updated info on counterfeit drugs coming from Mexico, external defibrillators, and meds like Zometa, Aredia and Natrecor.