No Shit. Really?

Did you ever see Broadcast News — and the scene where Albert Brooks is giving info to Holly Hunter for the nightly newscast over the phone? He’s bitter because he’s not the anchor; William Hurt is. But he does want the news to make sense, so he calls Hunter, who’s the producer, to give her a tip on how to cover a story. Within seconds, he hears William Hurt say exactly what he said, and he comments ruefully, to himself: “I say it here and it comes out there.”

For some reason that line comes to me sometimes, in childish I-told-you-so situations. So when I read the AP article titled: “Panel: Seroquel not 1st choice for depression,” I thought of that line. If Philip Dawdy saw the movie, he probably thought of that line too.

Of course Seroquel doesn’t work for depression. It’s an antipsychotic, people. It was created to treat schizophrenia, which — despite Big Pharma’s craven desires — IS NOT THE SAME AS DEPRESSION.

Here are some relevant tidbits, including some deliciousness about Seroquel causing diabetes. I went a little crazy with the bolds:

WASHINGTON (AP) — Federal health experts said overwhelmingly Wednesday that the side effects of AstraZeneca’s schizophrenia drug Seroquel are too worrisome to make it a first choice against depression.

However, the panel of Food and Drug Administration advisers also said the drug could be useful as a supplemental therapy for patients who are not finding relief with other antidepressant drugs.

Seroquel, which posted sales of $4.5 billion last year, is already approved to treat schizophrenia and bipolar disorder. Now the London-based drugmaker wants the FDA to approve it for patients with depression and anxiety disorder, a much larger population that includes more than 20 million U.S. patients.

But FDA regulators expressed concerns about allowing nearly 10 percent of the U.S. population to use a drug with side effects including weight gain, high blood sugar and potential heart problems.

Panelists voted unanimously that the drug was not safe enough for use as a first choice, stand-alone treatment of depression and anxiety disorder, given older, more established drugs.

“I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman, an NIH researcher who chaired the panel. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

FDA is not required to follow the advice of its panels, though it usually does.

Seroquel is part of a new generation of psychiatric medications, called atypical antipsychotics, thought to be safer than older medications. But a paper published in the New England Journal of Medicine earlier this year found that patients taking newer medications have the same likelihood of dying of a sudden heart problem. The study from researchers at the Vanderbilt University found there were about three deaths per year for every 1,000 patients taking older or newer antipsychotics.

“Our study provides evidence that this drug may produce a side effect that is of extreme concern to patients,” said Vanderbilt’s Dr. Wayne Ray, who was invited by the FDA to present his findings.

Many physicians already prescribe Seroquel and other antipsychotic medications to manage depression and anxiety. But FDA approval would allow AstraZeneca to market its powerful antipsychotic for those uses.

The company said there is a significant need for new depression treatments, pointing out that the disease returns in a third of patients treated with existing antidepressants. Many patients stop using the drugs due to side effects like insomnia, sweating and decreased sex drive.

Largely absent from the panel’s discussion was the ongoing debate about Seroquel’s possible role in contributing to diabetes, a controversy that has generated thousands of lawsuits against AstraZeneca in recent years.

However, more than a dozen members of the public — including spouses of patients who died while taking the drug — called on the FDA panel to deny approval of Seroquel for depression, with many citing its metabolic side effects.

“It is your job to keep Seroquel off the market for this expanded use unless the company can conclusively prove that it does not increase the risk of diabetes,” said Dr. Diana Zuckerman of the National Research Center for Women and Families.

Lawyers representing some 15,000 former Seroquel users claim AstraZeneca knew nearly a decade ago that the drug caused diabetes, but kept that information secret.

A brief released by the plaintiffs attorneys Wednesday morning claims that internal AstraZeneca memos and data show Seroquel is both risky and not very effective.

One study showed Seroquel was not effective against depression but a comparator drug was. Several other studies of Seroquel failed to prove that depression symptoms stopped or waned significantly by six weeks, according to the brief.

liz | 2:36 PM | BIG PHARMA, SCHIZOPHRENIA, depression, meds, side effects