Tuesday, March 31, 2009

Seek and destroy

"We may need to seek them out and destroy them where they live," a Merck employee wrote, referring to opinion leaders who criticized Vioxx. The Australian reports.

Monday, March 30, 2009

University of Medtronic

"Medtronic, a global leader in medical technology, has developed a case competition specifically for University of Minnesota students. This competition will challenge students from MBA, MHA and MPH programs to work together in small teams (3-6 people) to develop solutions to a contemporary issue faced by Medtronic that requires diverse industry expertise. Beyond the chance to work with students from other schools, make contacts in the medical device field, and showcase your abilities. The 1st place team will walk away with $6,000 and the 2nd place team will win $3,000. With a maximum of 8 teams competing, this is an excellent opportunity to earn some extra book money."

Read more here.

Amusing diversion, or sign of the apocalypse?

Drug firms' cash skews doctor classes

"A Journal Sentinel investigation found that industry-funded doctor education courses offered at UW often present a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects." Read more here.

Daniel Carlat comments on the report here.

Sunday, March 29, 2009

Were AHDH drugs hyped?

A large study suggests that the benefits of stimulants disappear after two years -- and they appear to stunt the growth of children. See The Washington Post.

Say good night to your frontal lobes ...

It was George Carlin who put it best:
"It's called the 'American Dream' because you have to be asleep to believe in it."

In this video  Peter Whybrow - author of "American Mania: When More is Not Enough" -  provides a neuroscientist's explanation for what he calls 'addictive abundance' ...

The best medicine...

Do you have feelings of inadequacy, problems of shyness: try tequila!

Saturday, March 28, 2009

Wrongful Life/Birth Lawsuit

The definition and an article of Wrongful Life/Birth. It seemed to me it's like a PL lawsuit against life resulted from comoddification of life and giving birth, even if the accuser thinks it's just a way to get money for medical treatment (or more).

And the article "High cost of malpractice insurance threatens supply of ob/gyns, especially in some urban area" is here.

If you stop paying a surrogate mother, what happens to the fetus?

William Saletan of Slate examines the financial scandal surrounding SurroGenesis, a surrogacy brokerage in California.

JAMA slammed

The Chicago Tribune weighs in on the JAMA affair.

Friday, March 27, 2009

Registering a fake IRB

This just in from Nature on the IRB sting operation:

"A three-legged dog named Trooper overseeing experiments on humans? An ethics committee named “Phak√© Medical Devices” and based in “Paynesville, South Carolina”? No problem, sign right up. It was a sting operation tailor-made for congressional theatrics, and the US House of Representatives Committee on Energy and Commerce obliged yesterday as they heard accounts of an undercover operation to expose weaknesses in the country’s fragmented system of human research oversight."

The doctor will see you now, if you promise to keep quiet

"If you think your doctor has cold hands or worse, has made a mistake in your medical care, what better place to sound off then an online review site. There are dozens of such sites, but now doctors are fighting back. Dr. Jeffrey Segal, founder of Medical Justice, provides releases to physicians that when signed, prohibit patients from inveighing online." On the Media reports.

Advertising is good for you

Courtesy of Advertising is good for you.

Thursday, March 26, 2009

Where the money is

What is the most profitable class of drugs in America? Not statins. Not antidepressants. Not drugs for hypertension or diabetes. The most profitable drugs in America are the antipsychotics. See this chart by IMS Health.

For-profit IRB approves protocol for a fake product

"Government investigators looking into lax screening of medical research said Thursday they easily won approval from a private review board of a fake product to be used in medical testing on human subjects."

"The Government Accountability Office also said it was able to register with the Health and Human Services Department a fictitious institutional review board, a panel of doctors and scientists that must approve any medical drug or device to be used in federally funded testing on humans. The president of this fake review board was a dog named Trooper."

The AP reports.

According to the WSJ Health Blog: "Rep. Greg Walden, R-Ore., criticized Health and Human Services officials for failing to catch the fictitious IRB and registering it despite numerous red flags. 'Nobody picked up on names like Phake Medical Devices, April Phuls, Timothy Witless and Alan Ruse - in the town of Chetesville, Ariz.?' he asked department reps."

What is your biological age?

Click here to find out, while sending all of your personal health information to drug marketers. The New York Times reports.

Tufts disinvites Grassley staffer

Tufts University has rescinded its invitation to Sen. Charles Grassley and a staff member, Paul Thacker, to participate in an ethics symposium, apparently because Grassley is investigating a Tufts faculty member for undisclosed conflicts of interest. The Boston Globe reports.

Wednesday, March 25, 2009

APA gives up pharma-funded CME?

"Amid the flak surrounding several prominent psychiatrists and their ties to the drug industry, the American Psychiatric Association has decided to drop all industry-sponsored meals and educational sessions from its annual conferences." The WSJ Health Blog reports.

The JAMA dust-up

"No one, as I recall, told me that I was banned from JAMA. But the tone of Dr. DeAngelis's e-mail gave me the very strong impression that I should not be surprised if none of the papers I might submit to that journal in the future ever found their way into print." In the blog for his book, Hooked, Dr. Howard Brody writes about his own treatment by JAMA when trying to investigate a fraudulent study.

talk of interest

“The Cultural Politics of Pain, from Percodan to Kevorkian” will be presented by Professor Keith Wailoo April 1, 2009 at 4:00 p.m. in Nolte 125. Click Here for More Info

98% of babies manic-depressive

The Onion reports.

Signing off ...

Where else but Oregon would a 50,000-watt radio station give dying people a voice on Death Bed Talk. City Pages' TD Mischke says the program is "shaking ...[listeners]...awake with bold, unvarnished candor."

Monday, March 23, 2009

Novartis Land?

"Employees at Novartis don’t just sit in training workshops. They ‘play’ their way to learning about the company’s code of ethics in "Novartis Land", an online training program offering the opportunity to interactively explore the policies and answer questions in an online dialogue-role-play setting." This is not a joke.

Prevnar study death in India

"A baby girl in India who died last year during a clinical trial for the Wyeth vaccine Prevnar did so because of 'supervisory shortcomings', not because of problems with the vaccine." The WSJ is reporting that she should never have been entered into the trial, because a sibling had died of a heart condition at four months of age, which should have been a red flag. Read more here.

JAMA demands silence from complainers

According to the Wall Street Journal: "The Journal of the American Medical Association, one of the world's most influential medical journals, says it is instituting a new policy for how it handles complaints about study authors who fail to disclose they have received payments from drug companies or others that pose a conflict: It will instruct anyone filing a complaint to remain silent about the allegation until the journal investigates the charge."

"The unusual order drew criticism from editors at other journals and fuels a debate about the role of medical journals in policing financial conflicts of researchers."

The WSJ Health Blog also reports on the new policy.

Drug reps get the axe

"The number of sales reps working for U.S. drug makers has fallen from 102,000 in 2007 to 92,000 today — and is projected to fall to 75,000 in the next few years." Read more in The WSJ Health Blog and American Medical News.

Friday, March 20, 2009

Medical Tourism

"WHEN Ben Schreiner, a 62-year-old retired Bank of America executive, found out last year he would need surgery for a double hernia, he started evaluating possible doctors and hospitals. But he didn’t look into the medical center in his hometown, Camden, S.C., or the bigger hospitals in nearby Columbia. Instead, his search led him to consider surgery in such far-flung places as Ireland, Thailand and Turkey." Read more in NYTimes. CBC article is here.

Call for end to drug firms' gifts

"Medical experts are calling for drug industry representatives to stop giving gifts to doctors, the BBC has learned." Read more in BBC. The Guardian article about developing countries is here.

God Complex

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.

Read more in the New York Times about Dr. Joseph Biederman's testimony in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.

Thursday, March 19, 2009

Cheerleaders Pep Up Drug Sales

"As an ambitious college student, Cassie Napier had all the right moves - flips, tumbles, an ever-flashing America's sweetheart smile - to prepare for her job after graduation. She became a drug saleswoman." Read more in NYTimes.

Seroquel fraud

"AstraZeneca has truly grabbed the brass ring of subterfuge. The Seroquel documents are revealing a company-wide pattern of blatant deceit and manipulation that is astonishing, and should make any psychiatrist think twice before believing anything Astra Zeneca has to say about Seroquel, either in the past, the present, or the future." Read more in the Carlat Psychiatry Blog.

Wednesday, March 18, 2009

Once-secret drug company records put U on the spot

"Documents raise questions about a drug study by U of M psychiatrist S. Charles Schulz. He says there is a 'misunderstanding' about the results he reported," according to the Star Tribune.

"In the spring of 2000, Dr. S. Charles Schulz attended a national medical conference to present favorable research on a new psychiatric drug called Seroquel. Schulz, chief of psychiatry at the University of Minnesota, reported that the drug was 'significantly superior' to the old gold-standard treatment for schizophrenia. In a press release by the manufacturer, AstraZeneca, he touted the 'dramatic benefits' of Seroquel's class of drugs."

"But newly released documents show that AstraZeneca knew the research didn't support the claim -- and knew two months before Schulz went public with it."

In a longer, more detailed story, The Pioneer Press reports that "a U spokesman said that the dean of the medical school, Dr. Deborah Powell, is aware of the controversy over Schulz's research and has offered him her full support. "

PharmaGossip comments here.

Meanwhile, in an AHC News Capsule, AHC VP Frank Cerra comments on financial conflicts of interest:

"I’d like to make a couple of points loud and clear, as I have publicly on several occasions. Yes, the faculty within the Academic Health Center – and indeed in other parts of the University – have relationships with industry. Our new ideas, our discoveries would never go anywhere if there weren’t a company willing to develop or manufacture the results of our work. And then those discoveries would never make it into the marketplace to both improve and enhance care and health. Yes, pharmaceutical and device manufacturers pay for clinical trial work taking place at the University. There is no other source of funds. And, yes, our faculty – physicians, pharmacists, dentists and others – are compensated for their time and work.

The Facebook scourge

"I'm not inflexible. But there is one promise I've made to myself. And that is that no matter how long I live, no matter how much pressure is exerted, no matter how socially isolated I become, I will never, ever join Facebook, the omnipresent online social-networking site that like so many things that have menaced our country (the Unabomber, Love Story, David Gergen) came to us from Harvard but has now worked its insidious hooks into every crevice of society." Matt Labash strikes back in The Weekly Standard.

Astra-Zeneca buried damaging Seroquel study

"The study would come to be called 'cursed,' but it started out just as Study 15. It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15's results suggested otherwise."

"As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised serious concerns about an entire new class of expensive drugs."

Read more in the Washington Post.

Tuesday, March 17, 2009

The Pfizer-funded fraud

"In what may be among the longest-running and widest-ranging cases of academic fraud, one of the most prolific researchers in anesthesiology has admitted that he fabricated much of the data underlying his research, said a spokeswoman for the hospital where he works," writes Gardiner Harris in the New York Times. From 2002 until 2007, Pfizer funded the work of Dr. Scott S. Reuben, who published work showing that Pfizer drugs Lyrica and Celebrex were effective against post-operative pain. The WSJ Health Blog comments here.

The Seroquel sex scandal

"Former AstraZeneca U.S. medical director for Seroquel Wayne MacFadden confessed his multiple sexual affairs, and his offer of drugs to one of the women he was sleeping with, to lawyers in December 2007. The confessions include descriptions of sex in hotel rooms paid for by AZ, illicit distribution of Vicodin, and a kinky relationship in which one of his colleagues asked to be 'punished' for looking at a study that had negative results for Seroquel." BNET Pharma reports.

"A nobody and a nothing"

This is how the editor of JAMA describes a critic who criticized the way she handled a conflict of interest. Read more in the WSJ Health Blog. The Knight Science Journalism Tracker weighs in here.

Saturday, March 14, 2009

FDA approves salmonella

"Calling it 'perfectly safe for the most part,' and 'not nearly as destructive or fatal as previously thought,' the Food and Drug Administration approved the enterobacteria salmonella for human consumption this week. The Onion reports.

The problem with pharma mergers

The problem with today's pharmaceutical industry is that its research and development is driven by marketing concerns, writes William Haseltine in his Atlantic blog. And merging two enormous, failed companies will just make the problem worse.

Friday, March 13, 2009

The great IRB sting operation

What happens when a for-profit IRB suspects that it is being set up for a sting by the federal government? Read the story in The New York Times.

Thursday, March 12, 2009

Beecher's Bombshell Revisited

Susan Lederer will present a Center for Bioethics seminar titled "Beecher's Bombshell Revisited: What the Editors Left Out of this Milestone in American Research Ethics" on Friday, March 13, 12:15 to 1:30 pm, in 3-100 Mayo.

Lederer is the Robert Turell Professor of History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health and Chair of the Department of Medical History and Bioethics. She has published extensively on the history of both human and animal experimentation. Her expertise on the history of American medical research prompted her appointment by President Clinton to the Advisory Committee on Human Radiation Experiments.

Premack award to Pioneer Press for series on research death at the U

Jeremy Olson and Paul Tosto have been awarded a Frank Premack Public Affairs Journalism Award for their series on the death of Dan Markingson in a clinical trial at the University of Minnesota.

The Premack judges wrote: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”

Winners will be honored at the Frank Premack Public Affairs Journalism Awards Program, held Monday, April 20, 2009 at 5:00 p.m. in the A.I. Johnson Room at McNamara Alumni Center.

Read the press release here.

Wednesday, March 11, 2009

Skin whitening big business in Asia

Philip Martin reports on the growing popularity of skin whitening products across Asia. Customers from Mumbai to Beijing say they want lighter skin, but health professionals are concerned. Hear more on PRI's The World.

Remembering Dan Markingson

Mistakes that contributed to the death of Dan Markingson should not be repeated, writes Carl Elliott in the St. Paul Pioneer Press.

Monday, March 09, 2009

Questioning Questionnaire Medicine ...

A former Colorado physician is being charged for practicing medicine in California without a license for prescribing generic Prozac to a college student over the internet. The student, who later committed suicide, completed a questionnaire in which he stated he needed to take the medicine to treat " attention deficit disorder in relation to depression." 
The student ordered the pills from an India-based company (usanetrx.com). The order was processed in Texas. The 90 pills were shipped from Mississippi. The Fort Collins-based doctor (who was licensed in Colorado at the time)  never saw or spoke with the patient. 

The parents of the deceased are suing all involved except the India-based company. 

Fee-for-service medicine in Romania

"Doctors and patients say the bribery follows a set of unwritten rules. The cost of bribes depends on the treatment, ranging from $127 for a straightforward appendix-removal operation to up to more than $6,370 for brain surgery. The suggested bribery prices are passed on by word of mouth, and are publicized on blogs and Web sites." Welcome to health care in Romania. The New York Times reports.

Rx: Take TRA if you are running out of Singulair

Pharmaceutical goliath, Merck, faced with an upcoming patent expiration on its big seller Singulair (~18% of company sales) is positioning to buy rival Schering-Plough, whose clot-buster TRA is expected to do quite well in the marketplace. Merck already cut over 7,000 jobs last fall.

Update: the deal is done, for $41.1 billion. The New York Times reports.

Sunday, March 08, 2009

Something for the human enhancement industry to ponder ...

"Perfection is attained, 
not when there is nothing left to add,
but when there is nothing left to take away."
~Antoine de Saint-Exupery~

Saturday, March 07, 2009

Jail time for drug talks?

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human services, in a New York Times interview about doctors who get industry kickbacks. Danny Carlat, aka Dr.Drug rep, offers some thoughts on the the Carlat Psychiatry Blog.

Friday, March 06, 2009

Another satisfied consumer

A restaurant-goer gets a Happy Meal at the Hospitalis Restaurant in Riga, Latvia.

Down with SFBC, up with Scripps

"Florida has decided to make a Texas-style bet on biotechnology. The strategy: entice world-class centers of biomedical research to establish local campuses." William Haseltine reports in The Atlantic.

David Foster Wallace profile

Wallace, who had been using an antidepressant called Nardil for many years, went off the drug in the summer of 2007 because he thought it was interfering with his writing. "He entered this new period of life with what [his friend Jonathan] Franzen calls 'a sense of optimism and a sense of terrible fear.' He hoped to be a different person and a different writer. 'That's what created the tension,' Franzen recalls. 'And he didn't make it.'" Read more in the current issue of The New Yorker.

TV doctor will not be surgeon general

Read more on the WSJ Health Blog.

Another Harvard psychiatrist is fingered

"Federal prosecutors say that a Massachusetts General Hospital psychiatrist became a 'star spokesman' in helping a pharmaceutical company promote its drugs for treating depressed children, even though the medications were not approved for pediatric use by the US Food and Drug Administration."

"In a complaint unsealed last week in US District Court in Boston, prosecutors allege that New York-based Forest Laboratories Inc. illegally marketed the drugs Celexa and Lexapro for use in children by paying kickbacks, including lavish meals and cash payments disguised as grants and consulting fees, to induce doctors to prescribe the drugs. They also say the company misled doctors and the public by failing to disclose the results of a negative study."

Read more in the Boston Globe.

Thursday, March 05, 2009

Olympic DNA tests

Baby Olympian? DNA test screens sport ability...

Transgender kids

How young is too young for a sex change? Read more in City Pages.

Wednesday, March 04, 2009

Grassley, Harvard and Pfizer

A Pfizer rep photographed Harvard student protesters, and Senator Grassley wants to know why. Read more here.

The Supremes on drugs

"In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators." The New York Times reports.

Star Tribune catches up on med school COI story

"Last year, the people crafting new conflict-of-interest rules for the University of Minnesota Medical School touted them as some of the toughest in the nation.

The 13-page draft banned gifts to faculty, researchers and students from drug and medical device companies. It barred the companies from funding continuing education. It established strict guidelines for reporting industry relationships, including disclosure to patients and the public.

But six months later, a slimmed-down, two-page version bearing a few notable changes is winding its way through the university's considerable bureaucracy toward approval by the Board of Regents." Read more from the Star Tribune.

Tuesday, March 03, 2009

3 Times a month = 3 Times a Lady ... or HSDD?

Not only is it unclear if "hypoactive sexual desire disorder"  (HSDD) is a disorder at all, but it remains highly debatable if Proctor & Gamble's 'Intrinsa' testosterone patch is even effective or safe. 

Monday, March 02, 2009

Harvard med students protest pharma money

"In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects. Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments." Read more in the Times.

Sunday, March 01, 2009

The diluted conlict-of-interest policy

Josh Lackner, a University of Minnesota medical student and a member of the conflict-of-interest task force, criticizes the Dean's revisions in the Daily.

Feds probe Emory

University of Minnesota, take note: federal officials are investigating Emory University to see if the university misled the NIH over Charles Nemeroff's lucrative financial ties to the pharmaceutical industry. The Wall Street Journal reports.

The Ironic Acronym

The American Society for Aesthetic Plastic Surgery - or, ASAPS - predict the following developments in their field in 2009. If you're feeling at all inclined here are some testimonials from Huntington Beach, CA (if you don't like your smile, I recommend Jennifer's testimonial. It provides 10 reasons you might consider a smile make-over).