FDA Warns Doctors About Zyprexa

From Spit. Bristle. Fury:

In news of the not-so-surprising, The LA Times reports that the FDA has issued awarning to doctors concerning increased metabolic risks in adolescents taking the drug olanzapine (Zyprexa). Risks include rapid weight gain and an increased likelihood of weight related physical concerns like diabetes and high cholesterol — serious problems that, you may remember, most doctors can’t be bothered to watch for. While this particular warning is limited to young people, you’ll find that the same risks are present in adults though it appears that adolescents are at a higher comparative risk. Interestingly, the warning applies only to those ages 13-17 being treated for diagnoses of schizophrenia and bipolar disorder, leaving out the growing number of even younger people for whom the drug is not approved but administered off label.

The agency has not approved the marketing of olanzapine — sold under the commercial name Zyprexa by the drug maker Eli Lilly — for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the “atypical antipsychotics,” is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.

The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels — all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs — Seroquel and Risperdal — were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.

Article continues here:

Jim Is In Serious Trouble, Can You Help Him?

From Yoism-
James Gottstein, founder of PsychRights is in trouble. Because he did the right thing.

James B. Gottstein, Esq., President and CEO of the Law Project for Psychiatric Rights (PsychRights), is a Harvard Law School alumnus, a 30+ year practicing attorney, and a psychiatric survivor.

And he is in trouble for doing the right thing.

We hope he will not be punished with loss of his law license, massive civil sanctions, and possibly even going to jail. However, the power of wealthy corporations to punish those who dare to oppose them even applies to whistleblowers like Jim Gottstein who have done what any moral person should do.

In a legal proceeding, Jim got hold of some secret Eli Lilly and Company documents, the Zyprexa Papers, that revealed terrible wrongdoing on Lilly’s part. This wrongdoing was destroying many thousands of lives. Drugs with serious side effects were being illegally marketed for the treatment of people for whom they had not demonstrated any effectiveness; and the dangerous side effects were actively downplayed and hidden. Eli Lilly, which, of course, always tries to deny any wrongdoing, has taken some responsibility for their misconduct by settling law suits for the terribly destructive medical complications — including death — that these illegally promoted drugs have caused. So far, they have paid out over two-and-a-half BILLION dollars to settle these suits.

So why is Jim Gottstein being punished?

Because he showed the documents to people. He sent the documents to a newspaper reporter at the The New York Times. Publication in The Times of information from these documents could and did help stop the fraud and helped make Eli Lilly accountable for what they had done. By bringing Lilly’s misconduct to light sooner, Jim has helped stop the destructive misuse of these dangerous drugs. By bringing Lilly’s misconduct to light sooner, Jim’s actions have prevented the destruction of hundreds, if not thousands of lives.

So, again, why is Jim Gottstein being punished?

Because the secret Zyprexa Papers had been obtained from Lilly in a case unrelated to Jim. Jim subpoenaed the documents from an expert who was examining them for that other case. The judge in that case ruled that Jim "conspired to steal" the Zyprexa Papers from Lilly when he subpoenaed them from Dr. Egilman in December of 2006, and then released them to the public, resulting in multiple front page articles in The New York Times.

Jim says, "I believe I did nothing wrong. When Lilly failed to object — after being given a reasonable opportunity to do so — and then Dr. Egilman sent the Zyprexa Papers to me, they had lost their secrecy protection."

But that doesn’t matter. It doesn’t matter who is right and who is wrong. Lilly can punish Jim even if they are wrong and he is right. They can do this by suing Jim Gottstein for releasing their secret documents that revealed THEIR wrongdoing.
So, Jim needs our help.

"Ever since Judge Weinstein ruled against me on February 13, 2007, Lilly has threatened me with civil and criminal contempt sanctions and going after my license to practice law. My legal fees in defending against Lilly's legal onslaught have so far been just under $300,000, including estimated unbilled fees, of which I still owe over $121,000. This has put me financially under water."

You can help by sending a check to the Jim Gottstein Defense Fund, or make a tax deductible charitable contribution online to the Jim Gottstein Legal Defense Fund Facebook Cause.

Jim Gottstein Legal Defense Fund
c/o Dominick Riccio, Ph.D.
1036 Park Avenue, Suite 1B
New York, NY 10028

PS. Please note: Jim is in need, but he did not ask us to post this.
Sometimes, people just have to do the right thing.

Susan's note-Holly and I have contributed, and belong to the group on Facebook. Jim is a real great guy, he doesn't deserve what he is going through. I hope my readers can help.

Midnight Musings- Flu and Eli Lilly

I went to sleep about 7 PM feeling miserable, woke up at 10:30, and shaking. Yep, temperature is back up to 102 and my winter flu is back with a vengeance.

I went on the couch, turned on the TV and the first thing I saw was this..."Real World Brooklyn". So.... My mom's generation the big question was- Does A Tree Grow In Brooklyn? Is mine going to be- Did Real World really have to go to Brooklyn? I don't know, but maybe this is a sign the Dodgers will come back to Brooklyn? I don't know. I am still mourning the loss of Coney Island. I am like Ferlingetti- I have a Coney Island of the Mind.

Meanwhile I would like to point out that Eli Lilly is on the verge of settling Zyprexa claims for a whopping 1.4 billion. This is being reported by Seattle journalist Philip Dawdy on his website Furious Seasons. For those not familiar with Dawdy, his site played a significant award role in the Zyprexa scandal, and documents on this can be found here.

I believe Philip and I both belong to the same Journalist society- I am writing them tomorrow to tell them about his tireless reporting on this issue.

Now that Zyprexa might have closure, I want to go after Haldol..... this drug is personal vendetta for me.

That's all I got for now. I want to go back to sleep and get rid of this cold. And wish I had my mom's chicken soup.