Wednesday, August 31, 2011

The accidental ghost author

Was a McGill University researcher fooled into writing a pharma-sponsored article?  Have a look and decide for yourself.

Tuesday, August 30, 2011

Presidential Commission meets to discuss clinical trials reform

The Presidential Commission for the Study of Bioethical Issues is meeting on August 29 and 30 to discuss historical abuses of human research subjects and potential reform of the guidelines for protecting them.  (Is anyone paying attention to this commission?)  You can see the webcast here.

Wednesday, August 24, 2011

A device disaster at Johns Hopkins

If you are looking for an example of what's wrong with the current system of regulating medical devices, have a look at the terrifying story posted on the Bioethics Forum by Dan Walter, whose wife, Pam, nearly died in a device study at Johns Hopkins in 2002.  Pam underwent an ablation procedure for atrial fibrillation at Hopkins, where Dr. Hugh Calkins, a paid advisor to Johnson and Johnson, was testing a J&J device called a Lasso Mapping Catheter.  Yet because Johnson and Johnson had claimed that the Lasso Mapping Catheter was "substantially equivalent" to earlier devices already on the market, the FDA did not require J&J to conduct clinical trials to prove that it was safe and effective.  So the study in which Pam participated, which, according to Walter, enrolled at least 517 subjects, was not overseen by the Johns Hopkins IRB.

The results were disastrous.  Here is the way Walter describes the procedure, which was performed by a Fellow in cardiology:

"Being new on the job and unfamiliar with the new catheter, the cardiology Fellow turned the catheter control knob to the left instead of the right, which transformed the lasso into a corkscrew that wound its way through the complex web of muscles of Pam’s mitral valve and became entangled there. The catheter was stuck. These and other details emerged in depositions and written statements as part of a lawsuit brought by my wife against the Hopkins doctors. After about 45 minutes, a colleague of Calkins’ was called in. With considerable difficulty, the catheter was finally removed, but in the process Pam’s mitral valve was damaged."


"The doctors took Pam down the hall to surgeons, who said that she might die if she did not have emergency open heart surgery to replace her valve. Shortly after the surgery, she suffered a stroke and hovered near death in a coma for the next three weeks."

In a case study published later, Calkins himself laid the blame for Pam's injuries on the design of the catheter.  But the Lasso Mapping Catheter remains on the market; device studies like this one are still not subject to IRB oversight; and and Johns Hopkins has done nothing to compensate Pam Walter.

You can read the full story in Dan Walter's alarming new book, Collateral Damage.

When you can't afford Walmart

Jack Hitt discusses the Dollar Store economy on Radio New Zealand.

Tuesday, August 23, 2011

Tell me more

If you're looking for a way to hook a reader, you really can't do much better than this:

"By the time the San Gabriel police caught up with Dr. Lars Hanson, he was half-naked, locked in his car and refusing to answer questions about a patient who had been sent to the ER from his unlicensed abortion clinic."

Read the rest of the story, as told by Bill Heisel, here.

Conflicts of interest and the NIH

The Project on Government Oversight has obtained a embargoed draft of the new NIH rules on conflicts of interest, and they have some questions for Francis Collins.  Read their blog post here.

Monday, August 22, 2011

Australian Seroquel trial aborted

A public outcry has prevented a trial of the antipsychotic drug Seroquel trial from getting off the ground, according to The Age.  This trial looks truly outrageous: children as young as 15 years old were to be given Seroquel as a preventive measure, in order to prevent them from developing a psychotic illness later in life.  Read about it here.

Friday, August 19, 2011

Dinner fresh from the pharm

A Syracuse restaurant is marketing itself as as "pharmaceutical dinner facility," writes Dan Carlat.

Monday, August 15, 2011

No comments, please

Up until recently, Facebook has given drug companies a privilege that others do not have: the ability to block specific public comments on a page Wall.  But that's changing.  Starting today, most drug company pages will be required to have open Walls.  And rather than make the change, many companies have decided simply to shut down their Facebook pages.  Read the article in the Washington Post.

Saturday, August 13, 2011

Guinea-Pigging with Ken Kesey

Here's some federal money well-spent: in the 1960s, the US government paid Ken Kesey $25 a day to take LSD at Stanford.  Kesey, Tom Wolfe, and Robert Stone talk to Fresh Air about the Merry Prankster years.

Saturday, August 6, 2011

Wyeth ghost author busted

Here's a first: McGill University has formally reprimanded senior professor Barbara Sherwin for failing to acknowledge a ghostwriter hired by Wyeth Pharmaceuticals.  McGill decided against sanctions, but even so, this reprimand is an encouraging sign that some universities are beginning to take ghostwriting seriously.  Read about it in the Montreal Gazette.

Friday, August 5, 2011

Unhealthy Obsession

A new radio documentary on hypochondria, by Karen Brown.  Listen here.

Institute of Medicine says device regulation process should be scrapped and replaced

The Institute of Medicine says that the current approach to regulating medical devices is so flawed that it ought to be scrapped.  But according to the editors of the New York Times, the IOM group has been the target of "scurrilous attacks" by device industry officials even before their report was issued (one of whom teaches at the University of Minnesota.)  Read the Times editorial here.

Thursday, August 4, 2011

The ghost behind the Globe and Mail

Yesterday, the Toronto Globe and Mail published a bizarre defense of pharma-sponsored medical ghostwriting.  Medical ghostwriting works like this: pharmaceutical companies hire medical writers to write scientific articles that make their products look good; then they persuade academic physicians to sign their names to the articles, in order to make the ghosted articles appear impartial and unbiased.  Medical schools have been slow to punish physicians who sign onto ghosted articles, but these days virtually nobody defends the practice of ghostwriting, which has figured prominently in most of the pharmaceutical fraud scandals of the past decade.  Nobody, that is, except for The Globe and Mail.

What could explain this odd editorial?  Maybe someone should ask the folks at Type A, a writing company that claims The Globe and Mail as one of its clients.  On the "Editorial/Ghostwriting" section of its website, Type A writes:

"Let’s face it, your clients are like most people; they want to make informed and independent decisions without being confronted with an obvious sales pitch. Which is why well-written industry articles are one of the most effective ways to deliver your message. But maybe you don’t have the time to craft the story yourself, or perhaps you can’t write as well as you need to. Why not enlist Type A to help you compose articles for key industry magazines, in print and on the web? For more than a decade, we have gained premium expertise ghostwriting industry articles and even e-books."

Type A even links to an example of ghostwriting it has done for the Globe and Mail.

Perhaps the editors of the Globe and Mail didn't have the time to craft the story they needed, or maybe they just couldn't write as well as they needed to.

Wednesday, August 3, 2011

Toronto Globe and Mail comes out in favor of pharma-sponsored ghostwriting

Here's my nomination for the most moronic, ill-informed editorial of the year: "In praise of ghostly scribes for scientists," by the editors of the Toronto Globe and Mail.  Never mind that ghostwritten journal articles have figured significantly in the most spectacular fraud cases in US history.  Forget all the patients who have died or been injured as a consequence.  You can't help but wonder: who is really writing the Globe and Mail's editorials?

Read it here. 

Tuesday, August 2, 2011

Attention, trial lawyers: your EZ guide to suing a pharma thought leader

Medical school professors routinely lend their names to ghostwritten, pharma-sponsored articles which they did not actually write.  This is fraud.  Yet just as routinely, medical school administrators look the other way.  The same goes for journal editors, research oversight bodies, and virtually everyone else in a position to stop the practice.  What's left to be done?

Sue the bastards, say Trudo Lemmens and Simon Stern, two law professors at the University of Toronto.  Ghostwriting distorts the scientific literature, harms patients, and undermines academic integrity.  It's time for the lawyers to step in.  Lemmens and Stern argue that professors who sign onto ghosted articles could be successfully sued in class actions based on RICO statutes.  Even better, they explain how to do it.  Read the article in PLOS Medicine.

Why not change minds instead of bodies?

The Atlantic interviews scholar-activist Alice Dreger about sexual anomalies, activism and the future of normality.  Read the interview here.

Monday, August 1, 2011

Furthur!

The Merry Pranksters are back, in Alex Gibney's new documentary, "Magic Trip: Ken Kesey’s Search for a Kool Place."  Read about it in the Times.