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 “Phaké 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.

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.

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."

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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~

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.

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.

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.

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.

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. 

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.

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). 

PsychNet

If you want to see what "thought leader" management looks like from the inside, have a look at this document from GlaxoSmithKline, courtesy of Senator Grassley. It concerns PsychNet, the GSK speaker's program that trained Paxil champions.

Love and serotonin

"There's every reason to think SSRIs blunt your ability to fall and stay in love," said Helen Fisher, a Rutgers University biological anthropologist who has pioneered the modern science of love." A reason, maybe, but is there any evidence? Read more in Wired.

More Seroquel secrets

Astra Zeneca buried unfavorable studies about Seroquel, according to internal emails uncovered in litigation. Bloomberg.com reports. And the WSJ Health Blog says, "Court documents suggest AstraZeneca told U.S. sales reps to say the antipsychotic drug didn’t cause diabetes, even though a company doctor had previously said that the drug could be linked to the disease in some patients."

A new kind of drug ad?

"What if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbs and calories of an Oreo cookie?" Dartmouth researchers say the FDA could make this happen, in the New York Times.

Should I fake or should I faux ...

In a Ted lecture entitled "What Consumers Really Want" Joseph Pine offers a provocative argument for a marketing movement he sees as 'rendering authenticity'. Viewed through the lens of medical enhancement technology one can't help but wonder about the 'pharmaceutical experience' and the quest for the real self.

Sex and Seroquel

The Seroquel litigation gets stranger and stranger. The complaint is posted on the Furious Seasons blog.

Are violent video games adequately preparing children for the apocalypse?

The Onion News Network reports.

The philosophy experiments

"A dynamic new school of thought is emerging that wants to kick down the walls of recent philosophy and place experimentation back at its centre. It has a name to delight an advertising executive: x-phi. It has blogs and books devoted to it, and boasts an expanding body of researchers in elite universities. It even has an icon: an armchair in flames. If philosophy ever can be, x-phi is trendy. But, increasingly, it is also attracting hostility." Dave Edmonds and Nigel Warburton examine experimental philosophy in The Prospect.

Surgeons successfully reconstruct man's face using leftover fingers

Doyle Redland reports for the Onion Radio News.

Illegal marketing by Forest?

"A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company’s marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs." Read the Department of Justice press release here.
The New York Times reports here.

Seroquel secrets

"A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?" Read more in BusinessWeek about Astra Zeneca's Seroquel.

Everything Conceivable

Liza Mundy talks about the fertility business on "Fresh Air."

Medtronic discloses

"Following years of pressure, medical device maker Medtronic Inc. will begin disclosing how much money it gives physicians in various consulting and other payments, though the reporting threshold is far less than currently proposed legislation." MPR reports.

The "other" other white meat

Because that's where the money is

The highest paid employee at Columbia University? A dermatologist, at $4,332,759 a year. At Cornell? A fertility specialist, at $3,149,376. Maybe this is why doctors are getting out of the disease business and into the enhancement business. Read more in the Times.

Minnesota Daily editors refuse to yield

The Minnesota Daily, responding to Frank Cerra's editorial, stands by its call for Dean Powell to recuse herself from the conflict-of-interest task force, pointing out that her relationship with PepsiAmericas gives her a financial stake in the outcome. Read more here.

Pfizer will disclose payments

Pfizer, like Eli Lilly, will begin disclosing the payments it makes to physicians. Read more here.

Art imitating life?

Was John Le Carre's book, The Constant Gardener, based on Pfizer's Trovan clinical trial in Nigeria? Jim Edwards looks at the evidence.

Pay for Performance

Critiquing the  'business of medicine' seems part history, comedy and tragedy, with the latter drama usually involving some compromise in the doctor-patient relationship. The latest attempt to encourage 'pay-for performance' as a potential antidote for the ills wrought by 'fee-for-service' seems like a tragedy waiting to happen.

Since when do doctors need incentives? Isn't the term 'patient advocate' a redundancy? Is the gerbil wheel an apt metaphor or is this more of a convoluted habitrail for patients and doctors to lose each other in?

Guinea pigs up north

Anne Silversides reports on the Canadian guinea-pigging scene in the CMAJ.

Medtronic's "Reclaim"

Minnesota Public Radio announced yesterday that Medtronic has received FDA approval for a new OCD treatment. The treatment, so to speak, consists of a small device that is implanted under the skin which delivers a steady series of electrical pulses to one's brain, intended to "block abnormal brain signals".

Offshore Outsourcing of Drug Trials on the Rise

An article published today in the New England Journal of Medicine raises ethical concerns of undue influence and potential exploitation of offshore workers. Although there appears to be no argument that such testing is on the rise, critics of the study say the study has major design flaws.

More on the U conflict of interest scandals

"Ethics reform for the medical school could have been open to public perceptions. In the end, it just didn't feel that way." Gary Schwitzer writes in the Daily.

Addendum: Schwitzer follows up on his Health News Blog, including this comment on Frank Cerra's editorial in The Minnesota Daily.

"How does he know the effort was misrepresented? He never attended one of the task force meetings. Whom does he refer to as the 'few who seem to want to influence the outcome outside of the process'? That’s a pretty vague broad-brushed attack against anyone who comments.

But his emphasis on the faculty’s thinking and the faculty’s voice is most troubling of all.

That shows the lack of a grasp for the importance of public input on the school’s conflict of interest policy – the very point of my guest column."

This is your army on drugs

"For the first time in history, a sizable and growing number of U.S. combat troops are taking daily doses of antidepressants to calm nerves strained by repeated and lengthy tours in Iraq and Afghanistan. The medicines are intended not only to help troops keep their cool but also to enable the already strapped Army to preserve its most precious resource: soldiers on the front lines." See "America's Medicated Army" in Time.

My doctor got 3 stars! ..Oh Yeah? Mine Got 4!!

Zagat is asking patients enrolled in the Blue Cross plan offered by Wellpoint Insurance to review their doctors. Reviews will be available online only to enrollees and edited by Wellpoint.

"Ms Zagat said in an interview that unlike food reviewers, patients are not encouraged to be 'pithy and witty' (you will not read how a doctor's 'icy hands' and 'crowded waiting room' made the exam a 'downer')."

I can see your point Ms. Zagat - the last thing we  (or Wellpoint?!) would want in a review is something 'pithy'. 

The empire strikes back

Frank Cerra attacks the Minnesota Daily for reporting on conflicts of interest at the University of Minnesota.

Trust us, it's good for you

Here's a novel argument: Astra Zeneca says it has to hide information about its antipsychotic drug, Seroquel, in order to protect the public. Kris Hundley reports.

FDA approves depressant drug for the annoyingly cheerful

My Drug Problem

"If I lived in New Zealand, I’d be dead," writes Virginia Postrel in the March issue of Atlantic Monthly.

Curious to know why? Read more of the article that Merrill Goozner calls "one of the most irresponsibly inaccurate pieces of medical reporting I’ve ever read."

Babymart

"Want a daughter with blond hair, green eyes and pale skin? A Los Angeles clinic says it will soon help couples select both gender and physical traits in a baby when they undergo a form of fertility treatment. The clinic, Fertility Institutes, says it has received "half a dozen" requests for the service, which is based on a procedure called pre-implantation genetic diagnosis, or PGD." The Wall Street Journal reports.

Drugmakers' push boosts 'murky' ailment

"Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions - including whether it's a real disease at all." The Associated Press reports on recent efforts by Eli Lilly and Pfizer to educate doctors about an illness known as fibromyalgia.

The story behind Zyprexa

"Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza." Ben Wallace-Wells reports in Rolling Stone. (Print this one out and read it carefully.)

Pharma has a nightmare

Public Citizen's Sidney Wolfe, the drug industry's most caustic critic, has gone to work for the FDA. Read more here.

Doughnuts are the new wheaties

Forget ultra-marathons. Put on a gorilla costume and take the Krispy Kreme Challenge.

Grassley speaks

The Philadelphia Inquirer profiles Sen. Charles Grassley, avenging angel of the anti-pharma insurrection.

FDA approves first pharm animal

"Opening the barn door to a new era in farming and pharmaceuticals, the Food and Drug Administration on Friday approved the first drug produced by livestock that have been given a human gene." More here.

Got milkweed?

"To the casual observer, Robert Holding seemed a kindly milkman who was attentive to his elderly customers as he delivered their daily pints.

To the less casual observer – specifically, a surveillance team from Lancashire police – Holding, 72, turned out to be a drug dealer who was supplying cannabis from his milk float to an elderly clientele.

His customers, who smoked the resin to relieve their aches and pains, would leave notes with their empty milk bottles to say how much of the drug they required. His reputation as a drug dealer spread rapidly among 17 of his customers in Burnley, Lancashire.

When detectives searched Holding's home last July they were astonished to find wraps of cannabis resin stashed among the eggs in his milk crates."

The Guardian reports.

How much for a kidney?

"The woeful inadequacy of our nation’s transplant policy is due to its reliance on 'altruism.' According to the guiding narrative of the transplant establishment, organs should be a 'gift of life,' an act of selfless generosity. It’s a beautiful sentiment, no question. In fact, I, myself, am a poster girl for altruism. In 2006, I received a kidney from a (formerly) casual friend who heard secondhand about my need for a transplant. In her act, there was everything for me to gain, and, frankly, not much for her. My glorious donor was moved by empathy and altruism as purely as anyone could ever be.

Yet, it is lethally obvious that altruism is not a valid basis for transplant policy. If we keep thinking of organs solely as gifts, there will never be enough of them. We need to encourage more living and posthumous donation through rewards, say, tax credits or lifetime health insurance."

More on organ markets from Sally Satel here.

Saturday, February 07, 2009

Moral

Distress

More and more health care providers find themselves conflicted over a wide array of perceived obligations that may not reflect the best interest of their patients:

http://www.nytimes.com/2009/02/06/health/05chen.html

Cosmetic neurology on demand

Stimulants for everyone? Martha Farah of the University of Pennsylvania defends the cosmetic neurology manifesto she and her colleagues produced for Nature on the WBUR public radio show, On Point. Among her critics is Tom Murray of the Hastings Center. Listen online here. Or download the mp3 file here. Subscribe to the podcast on iTunes, or here.

Lilly rep blows the whistle

"Robert Rudolph knew he was about to end his lucrative career at Eli Lilly & Co., but he had to say something.

Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?

Why had the company violated privacy rules by culling patient lists at doctors' offices?

Why was the company counting drug samples as sales, which would boost the stock price?

He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.

'I'd just been wrestling with this stuff for so long," he said in a telephone interview today. 'I was put in a position of breaking the law, in my view, or quitting.'"

Read more in The Philadelphia Inquirer.

For some, health care is a lottery

"People young and old crowd the hallway outside the locked door of the Arlington Free Clinic. They grip small pieces of paper that will determine whether they get in -- or give up and go home. It's lottery day, and 45 county residents who lack health insurance and money to pay for medical care are competing for 30 openings on a cold afternoon in January." The Washington Post reports.

Will Bush drug rule endure?

In the waning days of the Bush administration, the Food and Drug Administration issued new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients. McClatchy Newspapers reports that the Obama administration will have to decide whether to try to modify or reverse this late change in the FDA's oversight of off-label drug marketing.

An intellectual gigolo and the greatest analyst who ever lived?

"In November 1984, Jeffrey Masson filed a libel suit against writer Janet Malcolm and the New Yorker, claiming that Malcolm had intentionally misquoted him in a profile she wrote for the magazine about his former career as a Freud scholar and administrator of the Freud archives. Over the next twelve years the case moved up and down the federal judicial ladder, at one point reaching the U.S. Supreme Court. Had a successful Freudian scholar actually called himself an intellectual gigolo and the greatest analyst who ever lived? Or had a respected writer for the New Yorker knowingly placed false, self-damning words in her subject's mouth?"

Kathy Roberts Forde will be discussing her new book, Literary Journalism on Trial: Masson v. New Yorker and the First Amendment, on Thursday, February 5 at 4:00 p.m. at the University of Minnesota Bookstore in Coffman Memorial Union.

The new administration

"University of Minnesota Medical School Dean Dr. Deborah Powell is out. Senior Vice President of Health Sciences Dr. Frank Cerra is in – at least for now. The only question now is why." Emma Carew at the Minnesota Daily reports.

Tom Daschle's ethics troubles

Merrill Goozner at the Center for Science in the Public Interest has an interesting take on Tom Daschle's conflicts of interest.