F.D.A. Reveals It Fell to a Push by Lawmakers

F.D.A. Reveals It Fell to a Push by Lawmakers

By GARDINER HARRIS and DAVID M. HALBFINGER
Published: September 24, 2009

WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.

Quit Smoking with Cream of Tartar

Thanks and a tip of the Mad Hatter's Hat for this great information!

Link

Resource: Complementary and Alternative Medicine Wiki

It's about time!

PTSD and Lord Peter Wimsey

Mental Health in Fiction
Did Dorothy Sayer's fictional detective suffer from PTSD? It would seem so. Link
How writers get PTSD wrong in fiction.
PTSD in the Lord of the Rings, and
PTDS, the West Wing and the Apocalypse
Rachel Manga's PTSD handbook is also reccommended.
In The Incredible Elopement of Lord Peter Wimsey, Sayers tells another story of mental health. A lovely girl marries her doctor, who is pathologically jealous and abusive. By chance a former would-be suitor finds her in the remote Basque mountains, hideously changed - "the face white and puffy, the eyes vacant, the mouth drooled open... a dry fringe of rusty hair [clinging] to the half-bald scalp". From the suitor's description, Lord Peter Wimsey recognises the symptoms of thyroid deficiency, or hypothyroidism. He travels to see her, secretly feeds her the thyroid hormone she needs, rescues her, and restores her to health and beauty.

Senator Grassley's Sleuth

"Grassley's Sleuth Gets Press In Nature
Most of you are aware of a long-running campaign by Sen. Charles Grassley (R-Iowa) to ferret out undisclosed pharma company funding of academic researchers who also wind up taking federal research money. Well, it ain't the Senator who does all the digging that leads to him going after the likes of Emory University psychiatrist Charles Nemeroff and Harvard University psych researchers. Instead, it is Paul Thacker, a former journalist and an investigator for the Senator, who is making researchers' lives hell--and appropriately so. I've known this for a long time but have kept my yapper shut when writing about Sen. Grassley.

Anyway, Nature has a nice article on Thacker and it includes Nemeroff himself basically apologizing for his mess and claiming he was in compliance with disclosure rules plus other researchers defending Nemeroff. Please. In a political world filled with scum and manure, it's good to see one good guy in the fray. And since I'm such a good guy, I'm making a copy of the article (usually requires a subscription) available to all of you. I encourage you to download it and read it."

From Philip Dawdy's wonderful Furious Seasons - PDF on Thacker - Senator Grassley's NAMI investigator

Philip is doing his seasonal fundraiser. Please donate here.... http://www.furiousseasons.com/

More tasty pharma scandals - involving Pfizer and NAMI - are here.

Soul Doctors - Shamans and Jung in the New York Times

"MERCED, Calif. — The patient in Room 328 had diabetes and hypertension. But when Va Meng Lee, a Hmong shaman, began the healing process by looping a coiled thread around the patient’s wrist, Mr. Lee’s chief concern was summoning the ailing man’s runaway soul.

“Doctors are good at disease,” Mr. Lee said as he encircled the patient, Chang Teng Thao, a widower from Laos, in an invisible “protective shield” traced in the air with his finger. “The soul is the shaman’s responsibility.”

At Mercy Medical Center in Merced, where roughly four patients a day are Hmong from northern Laos, healing includes more than IV drips, syringes and blood glucose monitors. Because many Hmong rely on their spiritual beliefs to get them through illnesses, the hospital’s new Hmong shaman policy, the country’s first, formally recognizes the cultural role of traditional healers like Mr. Lee, inviting them to perform nine approved ceremonies in the hospital, including “soul calling” and chanting in a soft voice."

Shamans
Shaman slide show

"This is a story about a nearly 100-year-old book, bound in red leather, which has spent the last quarter century secreted away in a bank vault in Switzerland. The book is big and heavy and its spine is etched with gold letters that say “Liber Novus,” which is Latin for “New Book.” Its pages are made from thick cream-colored parchment and filled with paintings of otherworldly creatures and handwritten dialogues with gods and devils. If you didn’t know the book’s vintage, you might confuse it for a lost medieval tome.

And yet between the book’s heavy covers, a very modern story unfolds. It goes as follows: Man skids into midlife and loses his soul. Man goes looking for soul. After a lot of instructive hardship and adventure — taking place entirely in his head — he finds it again.
Some people feel that nobody should read the book, and some feel that everybody should read it. The truth is, nobody really knows. Most of what has been said about the book — what it is, what it means — is the product of guesswork, because from the time it was begun in 1914 in a smallish town in Switzerland, it seems that only about two dozen people have managed to read or even have much of a look at it."

Jung

Turning off the drug company drip feed to doctors

Turning off the drug company drip feed to doctors

"In the United States, the world's biggest drug company Pfizer has agreed to pay a record US$2.3 billion to settle civil and criminal actions brought against it for illegally marketing a painkiller that has since been withdrawn from sale.

Pfizer allegedly instructed sales staff to tell doctors that the drug Bextra could be used to treat acute pain at doses well above those approved by health authorities, even though dangerious side effects - risks to kidneys, skin and heart - increased with dosage.

It's a blatant example of a pharmaceutical company trying to boost profits by swaying the professional decisions of clinicians - something that also happens here in Australia - whether it's drug company freebies like the branded pens and notepads that litter doctors desks, or industry sponsored conferences and education sessions.

Regulating the relationship between doctors and drug companies is an issue that has been excercising the mind of Philip Mitchell, Scientia Professor and Head of the School of Psychiatry at the University of New South Wales.

From the Australian Broadcasting Corporation
Listen now | download audio here.