University of Minnesota is in ethics trouble again

"In May 2006, University of Minnesota spine surgeon David Polly urged a Senate committee to fund research into the severe arm, leg and spine injuries suffered by soldiers in Iraq and elsewhere.

Dr. Polly told the committee he was testifying on behalf of the American Academy of Orthopaedic Surgeons and referenced his prior work caring for soldiers as a surgeon at the Walter Reed Army Medical Center.

What Dr. Polly didn't disclose during his testimony was that his trip to Washington was paid for by Medtronic Inc., the big medical-device maker whose bone growth product, called Infuse, has been used to treat soldiers, according to company records.

Dr. Polly and colleagues in Minnesota subsequently received a $466,644 Department of Defense grant for a two-year study beginning in February 2007 to evaluate Infuse in cases where an injury is also infected, according to the university.

Dr. Polly was paid $1.14 million by Medtronic for consulting services from 2004 to 2007.

Details of Dr. Polly's consultant billing were provided by Medtronic to Sen. Charles Grassley, an Iowa Republican who has been scrutinizing the relationship between academics and industry."

Read more in The Wall Street Journal. See also this article in the Minneapolis Star Tribune.

When drug trials go terribly wrong

Christopher Lane of Northwestern University, the author of Shyness: How Normal Behavior Became a Sickness, blogs for Psychology Today about the death of Dan Markingson in a University of Minnesota drug trial.

Dr. Whistleblower

"Dr. Romney C. Andersen, a Walter Reed Army Medical Center surgeon, was surprised last summer when his neighbor, a fellow doctor, congratulated him on a new medical journal study bearing his name.

What study?” Dr. Andersen asked. Soon, he was not the only person asking questions. Army officials, alerted by Dr. Andersen, began an investigation. They uncovered an apparent case of falsified research by a doctor who had befriended Dr. Andersen when they both worked at Walter Reed, treating American soldiers severely injured in Iraq."

Read more in the New York Times.

Give Blood Pressure Drugs to All

Blood-pressure-lowering drugs should be offered to everyone, regardless of their blood pressure level, as a safeguard against coronary heart disease and stroke, researchers who conducted a meta-analysis of 147 randomized trials (comprising 958,000 people) conclude in the May 19 issue of BMJ.

“Guidelines on the use of blood-pressure-lowering drugs can be simplified so that drugs are offered to people with all levels of blood pressure,” write Drs Malcolm R Law and Nicholas Wald (Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, UK). “Our results indicate the importance of lowering blood pressure in everyone over a certain age, rather than measuring it in everyone and treating it in some.”

“Whatever your blood pressure, you benefit from lowering it further,” Law told heartwire . “Everyone benefits from taking blood-pressure-lowering drugs. There is no one who does not benefit because their blood pressure is so-called normal.”

Six years ago, Law and Wald advocated the use of a polypill--containing a statin, three blood-pressure-lowering drugs (each at half the standard dose), folic acid, and aspirin--which they maintained could prevent heart attacks and stroke if taken by everyone 55 years and older and by everyone with existing cardiovascular disease.

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Opening up the FDA?

The FDA may see some changes soon, says the New York Times. "The goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers."

Why is McAllen, Texas the most expensive place in America to get medical care?

Atul Gawande explains why expensive care is often the worst care in The New Yorker.

webcast your brain surgery

The rising popularity of Twittering and webcasting live from the operating room. Hospitals use it as a marketing tool...includes a quote from Jeffrey Kahn.

"Corinne insisted, I have no moral compass. The most damning illustration has to do with her (now former) job as a pharmaceutical sales rep, where she said she knowingly sold drugs to physicicans that she knew would kill people. 'Selling drugs is a lie. I sold drugs that I knew damn well—I sold Vioxx for Merck before it got taken off the market for killing people. I knew damn well it was dangerous; I went around telling them to write it. There’s a lot of serious lying I’ve done in my life,' she said. That’s okay, Corinne told me, because 'I’m doing a job. For me, in that case, Merck told me to go out and sell drug even though I had hesitation about it. It’s not for me to say.'"

Read more about this drug rep/Survivor-contestant here.

The dangers of new drugs

A Cornell psychiatrist explains how his residents ignore proven drugs in favor of the cool new ones, in the New York Times.

Pass/Fail

According to a study at the University of Virginia, medical students on a pass-fail grading system perform as well as those on an A through F scale, and they have fewer symptoms of anxiety and depression. Read more here.

Pharma CEO paychecks

Which pharma CEOs are paid the most? The list is topped by Bill Weldon at Johnson and Johnson, who was paid $29.4 million last year. Next in line were the CEOs of Abbott, Wyeth and Bristol-Myers Squibb. Fierce Pharma reports.

The politics of desperation

"A Virginia family’s campaign for access to an unproven drug highlights the challenges many terminally ill patients face in the search for treatment." Read more in the NY Times.

Electroboy versus Bristol Myers Squibb

NIH says maybe, maybe not

"The National Institutes of Health, after months of pressure, announced last week that it would consider imposing tougher regulations aimed at reducing financial conflicts of interest in scientific research. But it might actually not do anything."

Read more in The Chronicle of Higher Education.

Google wants to know if you're sick

"Google is attempting to find out how much of a role Internet searches play in the self-diagnosis process". Here.

Medtronic, the Defense Department and the University of Minnesota

The Center for Public Integrity reports.

Slate founder says: ban lawsuits against the device industry

Michael Kinsley warned Congress that "lawsuits would prevent patients from getting access to devices. Identifying himself as a grateful customer of the pharmaceutical industry, he said he had had Parkinsons 15 years. He noted that he was testifying at the request of Medtronic, which approached him last week, though he wasn’t paid by them." The WSJ Health Blog reports.

The future of medicine?

"I am not your typical doctor. I'm easily accessible and mobile," Dr. Jay tells us via his website. That's right: for a yearly enrollment fee, you can IM Dr. Jay about your symptoms anytime. He also makes house calls—or, you know, wherever calls! "We can figure out if I need to come to your work, your home, or meet somewhere else in the city. We can even meet in the park or a coffee shop depending on the problem. Wherever you feel comfortable."

Gawker comments. See Dr. Jay's strange website here.

Insurer backs kidney-matching network

The WSJ Health Blog reports.

Elsevier published at least six fake medical journals

Ben Goldacre reports for the Guardian.

Grassley vs Wagner

An influential U.S. senator has told a federal investigator that a University of Texas System researcher may not have properly disclosed her financial relationship with a drug company.

The inspector general at the U.S. Department of Health and Human Services could launch an inquiry into the scientist, UT child pharmacology researcher Karen Wagner.

The Dallas Morning News reports.

Legislature approves bill limiting mentally ill patients' participation in drug trials

A bill before Gov. Tim Pawlenty would restrict the ability of clinical drug researchers to enroll mentally ill patients who are under court commitment orders.

The House and Senate both voted unanimously this week in favor of the bill, which was motivated by the suicide of schizophrenic Dan Markingson. Friday marks five years since his death in a group home in West St. Paul.

At the time, Markingson was enrolled in a comparative drug trial at the University of Minnesota — despite objections from his mother that he was coerced into the trial and should be withdrawn.

Read more in the Pioneer Press.

Fire man

Thanks, Maran, for spotting this.

Synthes settles

"The New Jersey attorney general has announced a settlement with a medical device maker accused of failing to disclose financial conflicts of interest among doctors researching its products, and says her office is investigating other similar conflicts in the device industry," says the New York Times. Read more here.

Thought leader repents

Dr. James Stein of the University of Wisconsin, a former industry thought leader, talks about his change of heart in this video.

More About the Mighty Potato

Potatos are hot, hot, hot! And the creator of the "classic American potato," Luther Burbank, is featured not only in the novel we are reading for class, Ruth Ozeki's All Over Creation, but also in a new book reviewed Sunday in the New York Times.

Jane S. Smith has written a biography of Burbank, titled The Garden of Invention: Luther Burbank and the Business of Breeding Plants.

According to the review, Smith writes that the type of russet potato Burbank developed became so popular that McDonald's insisted on its use for the making of its French fries. "Then, in 1995, the Monsanto Corporation would genetically modify the russet Burbank so that the potato could produce its own pesticide to repel the Colorado potato beetle."

And did you know that 2008 was declared the "International Year of the Potato" by the United Nations? Nope, neither did I. That lucky spud.

Merck published fake journal

The Scientist: NewsBlog:

Merck published fake journal

Posted by Bob Grant

[Entry posted at 30th April 2009 04:27 PM GMT]

View comments(18) | Comment on this news story

Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship. "I've seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle." The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.) The claim that Merck had created a journal out of whole cloth to serve as a marketing tool was first reported by The Australian about three weeks ago. It came to light in the context of a civil suit filed by Graeme Peterson, who suffered a heart attack in 2003 while on Vioxx, against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA). In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]." He also stated that four of the 21 articles featured in the first issue he reviewed referred to Fosamax. In the second issue, nine of the 29 articles related to Vioxx, and another 12 to Fosamax. All of these articles presented positive conclusions regarding the MSDA drugs. "I can understand why a pharmaceutical company would collect a number of research papers with results favourable to their products and make these available to doctors," Jelinek said at the trial. "This is straightforward marketing." Jelinek also pointed out several "review" articles that only cited one or two references. He described one of these articles as "simply a summary of an already published article," and noted that they were authored by "B&J Editorial." "It appears that 'B&J' (presumably Bone and Joint) refers to the Journal, and B&J editorial presumably to the publishers or owners as there is no editor of the journal," Jelinek said in his testimony. "This is a subtle attribution, and many readers may not realise that the paper was written by the owners or publishers of the journal, presuming that is who would write under the heading of 'editorial'." Lurie, in examining two of the issues for The Scientist, agreed that one particularly strange element of the Australasian Journal of Bone and Joint Medicine is that it contains "review" articles that cite just one or two references. "I've never seen anything quite like this," he said. "Reviews are usually swimming in references." For example, one article on osteoporosis labeled above the title as a "meta-analysis" cites two references -- one itself a meta-analysis. "To the jaundiced eye, [the journal] might be detected for what it is: marketing," he said. "Many doctors would fail to identify that and might be influenced by what they read." Lurie noted that the Australasian Journal of Bone and Joint Medicine is akin to other publishing strategies employed by drug companies; paying for supplements to existing journals or publishing compilations of original research articles that tend to lack scientific rigor (so-called "throwaways"). "It's kissing cousin to two other tricks that the [drug] companies pull." In response to several questions about the publication posed by The Scientist, an MSDA spokesperson wrote in an email: "MSDA understood that Elsevier envisaged the complimentary publication would draw on the vast resources of Elsevier, publishers of many leading peer-reviewed journals including Lancet, Bone, Joint Bone Spine and others, to deliver novel and timely full text articles and abstracts to physicians." Many of the articles appearing in the Australasian Journal of Bone and Joint Medicine were in fact reprints or summaries of studies that originally appeared in other Elsevier journals. A spokesperson for Elsevier, however, told The Scientist, "I wish there was greater disclosure that it was a sponsored journal." Disclosure of Merck's funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist. Elsevier acknowledged that Merck had sponsored the publication, but did not disclose the amount the drug company paid. In a statement emailed to The Scientist, Elsevier said that the company "does not today consider a compilation of reprinted articles a 'Journal'." "Elsevier acknowledges the concern that the journals in question didn't have the appropriate disclosures," the statement continued. "It is worth noting that project in question was produced 6 years ago and disclosure protocols have evolved since 2003. Elsevier's current disclosure policies meet the rigor and requirements of the current publishing environment." The Elsevier spokesperson said the company wasn't aware of how many copies of the Australasian Journal of Bone and Joint Medicine were produced or how the publication was distributed in Australia, but noted that "the common practice for sponsored journals is that doctors receive them complimentary." The spokesperson added that Elsevier had no plans to look further into the matter. One of the members of Australasian Journal of Bone and Joint Medicine's "Honorary Editorial Board," Peter Brooks, a rheumatologist in Australia, said he didn't recall who asked him to serve on the board, but noted that he was on Merck's Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago. As for the Australasian Journal of Bone and Joint Medicine, he said, "If it would have been put to me that [the journal] was just sort of a throwaway, then I would have said 'no'" to serving on its editorial board. He said he was never paid for his role, adding that he "didn't ever get [manuscripts] to review or anything like that," while on the board, because the journal did not accept original manuscripts for review. "Having looked at one issue, it actually had some marketing studies," Brooks said. "It also had papers that were excerpted from other peer-reviewed journals. I don't think it's fair to say it was totally a marketing journal." Editor's note (April 30): This story has been updated from a previous version. Related stories: Elsevier expands biopharma base [11th March 2008] Merck's fall from grace [May 2006]

FDA approves Drug for the Annoyingly Cheerful

The Onion News Network: FDA approves Drug for the Annoyingly Cheerful

Another pharma doc repents

The 1990s was a heady time for the pharmaceutical industry, which had just embarked on what would become known as the Statin Wars. And James Stein, an up-and-coming heart doctor, was ripe to be hooked as a drug company speaker.

Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors.

It would be his first taste of life as a drug company speaker and consultant.

Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk.

He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check.

"I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans," Stein said in a presentation at UW this month.

Read more in the Journal Sentinel.

A pharma celebration?

"In what may be the biggest break that the Food and Drug Administration and the pharmaceutical industry have had in years, GOP Sen. Charles Grassley could step out of his leading role on the Senate Finance Committee to take the top Republican spot on the Judiciary Committee." Alicia Mundy reports.

A misuser's guide to Adderall

Dr. Larry Diller advises students on Adderall in The Harvard Crimson.

IoM advises stopping pharma gifts to doctors

WASHINGTON — In a scolding report, the nation’s most influential medical advisory group said that doctors should stop taking much of the money, gifts and free drug samples that they routinely accept from drug and device companies. Read the New York Times story here.

Stimulating Undergraduates ...

Margaret Talbot reports on the off label use of neuroenhancing drugs by students in the latest issue of The New Yorker.

Database restored

The St. Paul Pioneer Press has restored its searchable database of pharmaceutical industry payments to Minnesota physicians. You can try it here.

Merck ghosts in Oz

"Merck had a cardiologist sign his name to a medical journal article it wrote claiming there was no evidence of any heart risk attached to its drug Vioxx, court documents allegedly show." More evidence of corporate wrongdoing emerges in litigation against Merck in Australia, The Australian reports.

Spend your dwindling cash supply on sleep meds

Anxious Americans are losing sleep over their finances. This makes them a perfect mark for the National Sleep Foundation. Read more here.

Coast IRB folds

"Companies typically die slow, lingering deaths, the victims of changing technologies or tectonic shifts in global trade. But it is possible to kill a company really fast." The New York Times reports the demise of Coast IRB, the for-profit review board caught up in a federal sting operation.

Blogging for dollars

"Increasingly, companies are paying users of social networking sites like Facebook and Twitter to hype their brands online." On the Media reports.

Worst story ever for Times?

"The Health News Review gave a big "F" to this week's New York Times' coverage of the Dendreon press release claiming Provenge had proved successful in treating prostate cancer. The story "fails readers in every important way," the review said." Read more on Gooznews.

My doctor, my artist

"A thing of beauty is a joy, whether forever or for a day, and if a doctor-artist can turn you into one, that’s art to me. And if he can rescue a body from serious ruin and a soul from despair, God bless him; he’s as good as Michelangelo. Does he cater to the rich and charge too much? Check out all the drecky Picassos still selling for huge prices at auction. Do all those nose jobs look pretty much alike? Check out paintings in Chelsea galleries these days."

Read about “I Am Art: An Expression of the Visual & Artistic Process of Plastic Surgery,” a new gallery show curated by a plastic surgeon, in the New York Times.

The friendly fascism of posthumanism

Listen to Andrei Codrescu discuss his new book, The Posthuman Dada Guide.

Psychiatrists get the most pharma money in Vermont

Psychiatrists top the list of specialties receiving gifts and payments from the drug industry in Vermont, says a report from the state attorney general. Eli Lilly tops the list of industry donors. Read more in the WSJ Health Blog.

Is the FDA bipolar?

Martha Rosenberg writes about some recent FDA approvals.

It's time to pump it up ....

... then push up daisies?

A NY times article on the emerging, and potentially dangerous, underground silicone injection culture. 'Pump parties' are particularly popular in the transgender  community. Injections are performed by untrained and unlicensed individuals with non-medical silicone which can be contaminated with foreign materials such as paraffin and motor oil, occasionally  leading to sepsis or embolism. The cost per treatment can be as high as $1,000.

The future of medical care

David Healy delivers the 2009 Nordlander Lecture in Science and Public Policy at Cornell University, titled "The Future of Medical Care: Can Industrialized and Marketized Healthcare be Made Universally Available?" The video of the event can be found here.

Unknown Hinson for Liquid Chicken

Giving away the store

"A new plan to give away trade secrets could improve big pharma’s awful reputation,"writes Jim Giles in The Prospect. And the plan is being proposed by the new CEO of GlaxoSmithKline. Read more here.

Jeers to JAMA

Adriane Fugh-Berman and Douglas Melnick on the JAMA affair.

Coast IRB agrees to stop reviewing studies

Coast IRB, the for-profit IRB that was stung by a federal undercover operation, has agreed to stop reviewing FDA-regulated studies. Read more here.

Let's Test Every Pregnant Woman's Thyroid Level ...

The female equivalent of PSA testing?

If hypothyroidism, hyperthyroidism, pre-eclampsia, and miscarriage don't grab your attention, how about children with subpar IQ levels?

Will the benefits outweigh the risks and costs of testing over 6 million pregnant women each year?

Universal testing with a false negative rate of 1/3 in hypothyroidism and 2/3 in hyperthyroidism .... hmmm 

The compliance chip

"Microchips in pills could soon allow doctors to find out whether a patient has taken their medication." Read more here.

Camming your Moles

Blue Cross & Blue Shield of Minnesota is unveiling a virtual clinic for its 10 thousand employees this fall.

The pilot project offers a 10-minute live consultation at an undisclosed flat fee and is projected to be a money saver. 

The nifty site will offer a 'Time Remaining' digital clock so the patient and doctor know when time is running out. 

No word yet on the evaluation protocol for ear aches or hemorrhoids. 

It's time to fight the "PharmaScolds"

So says an editorial in the Wall Street Journal: "These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists."

Falsified studies at Harvard

A Merck doctor falsified a research study when he was on the faculty at Harvard, according to the Office of Research Integrity. Read more here.

This should come in handy at the U

Researchers at the University of Minnesota report they have found a drug to prevent stealing. Read more here.

Triumph of public relations at Hopkins

To great fanfare, Johns Hopkins University announces its new conflict of interest policy, which looks more like good PR than a genuine restriction on industry influence. See Daniel Carlat's reaction here.

Seroquel for depression?

"A government panel opened the door a crack yesterday toward allowing AstraZeneca to sell its Seroquel XR more widely, after an emotional meeting that included stories from two families who say their loved ones died after taking the powerful antipsychotic." Read more here.

Raptiva to go

Genentech is withdrawing its troubled immunosuppressant drug, Raptiva, from the market, because of a link to a rare brain infection. (If Raptiva sounds familiar, that may be a result of its link to a couple of research scandals, which appear to be unrelated. See here and here.)

Here comes Lily Allen

The British pop star, who performs in Minneapolis this weekend, sings about media-driven materialism turning us all into "weapons of massive consumption."

But not only that.

These days, everyone's on drugs of one kind or another:

"Everyone from grown politicians to young adolescents/prescribing themselves antidepressants."

Do free markets corrode moral character?

Of course they do, says Michael Walzer. But that in itself is no argument against the free market.

Fake journal for Vioxx studies?

Merck invented a medical journal called the The Australasian Journal of Bone and Joint Medicine, and passed it off as a peer-reviewed scientific publication, according to lawyers suing Merck in Australia. Read more here.

Grassley takes on advocacy group

Sen. Charles Grassley is investigating the National Alliance for Mental Illness, a patient advocacy group that is heavily funded by the pharmaceutical industry. Read more here.

Keller to step down at Brown

Martin Keller, chair of psychiatry at Brown University and a notorious figure in the conflict-of-interest battles, is stepping down in June, according to Alison Bass.

Is the Trovan story finally over?

"Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic," says The Washington Post. If the case is settled, it will end the story of one the most notorious cases of pharmaceutical industry exploitation of the developing world. (For background on the Trovan scandal, see this article.)

Marcia Angell explains how to reform the FDA

See "Charting a new course at the FDA" in The Boston Globe.

How to invent a disease

The vice-president of Pharmacia explains how his company invented and marketed the disease of "overactive bladder." Read more here.

Abducting and Selling Boys in Rural China

A disturbing report from the April 4, 2009 New York Times:

"If you have only girls, you don't feel right inside," said Ms. Zhen, who has one child, an 11-year old son. "You feel your status is lower than everyone else."

The Seroquel plot thickens

"AstraZeneca P.L.C. paid Florida child psychiatrist Jorge Armenteros to talk to other doctors about prescribing Seroquel, the company's powerful antipsychotic. And until yesterday, Armenteros also was listed as the chair and a voting member of a Food and Drug Administration advisory committee with a lot of power over Seroquel, which generated $4.45 billion in sales last year for AstraZeneca." More twists in the litigation over Seroquel, reported in the Philadelphia Inquirer.

Walk it off, crybaby

Doyle Redlund reports.

Shrink scandals

"Virtually all the psychiatrists who wrote the latest clinical guidelines for how to treat depression, bipolar disorder, and schizophrenia had financial ties to drug companies, according to preliminary findings by Boston-based researchers." The Boston Globe has more.

The V-Squad

How do you sell a painkiller that causes heart attacks and stroke? That's a job for the V-Squad. This video, which emerged in litigation against Merck, was used to train the drug reps detailing Vioxx

"Zero-dollar" policy for professional medical associations?

A group of physicians is recommending that doctors drafting practice guidelines for professional medical associations (PMAs) take no corporate money whatsoever.  However ...irony of ironies ... their article was published in the April 1st issue of JAMA! Who's foolin' who?!

Aimee Mullins: How My Legs Give Me Super Powers

"Aimee Mullins: How My Legs Give Me Super Powers".

An interesting perspective on enhancement vs. disability.

Stanford discloses, sort of

"Stanford University’s medical school will begin to publicly identify doctors and other faculty members who receive more than $5,000 annually from drug and medical-device companies — but it won’t put an exact figure on how much they were paid." See the WSJ Health Blog.

Mania

David Healy "has vaulted to prominence as a fierce critic of standard professional practice; of the role of Big Pharma – the collective name for large pharmaceutical companies – in reconstituting the very terms in which we as a culture understand and respond to mental illness; and of the biobabble that these days has replaced psychobabble as the verbal camouflage for our ignorance about the aetiology of mental illness."

"Along the way, he has exposed the extraordinary venality of many leading academic psychiatrists; the widespread ghostwriting of what purport to be cutting-edge publications in major journals (apparently produced by eminent scientists but actually concocted by public relations flacks for the pharmaceutical houses); the routine suppression or gross misinterpretation of data on the effects of psychoactive drugs along lines which maximize the profits of the huge multinationals (who thereby extract obscene sums from the sufferings of the mentally ill); the heightened risk of suicide and other untoward events that, perversely, may accompany the ingestion of antidepressants; and the fraudulent “science” on which many contemporary understandings of mental disorder rest."

"Small wonder that for many Healy has become a professional pariah, and that he plausibly reports being hounded, menaced and attacked by the enormously powerful corporations whose profits he threatens."

Andrew Scull reviews Healy's latest book, Mania, in The Times.

Our Father of Perpetual Abstinence

During a recent visit to Africa Pope Benedict XVI said that HIV/AIDS is "a tragedy that cannot be overcome by money alone, that cannot be overcome through distribution of condoms ... which can even increase the problem. "

The British medical journal, Lancet, has countered that His Holiness has 'publicly distorted scientific evidence'. 

The gloves are off ... (Lancet, apparently, recommends keeping them on).

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.

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.

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!

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.

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.