MED STUDENTS PUT HARVARD CONFLICT-OF-INTEREST POLICIES UNDER THE MICROSCOPE

by Alexandra Andrews, ProPublica

Two rival gangs are battling it out at Harvard Medical School. No, they're not fashioning makeshift weapons out of stethoscopes and tongue depressors, but there are millions of dollars at stake, along with what some say is Harvard's reputation.

The first group, made up of around 200 students and faculty members, is "intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard's 17 affiliated teaching hospitals and institutes," reports today's New York Times.

Harvard recently earned an F from the American Medical Student Association, which grades medical schools' conflict-of-interest policies on money from the pharmaceutical industry, even as other top-tier schools like the University of Pennsylvania, Stanford and Columbia secured A's and B's.

Harvard also faced embarrassment last year when Sen. Charles Grassley (R-IA) accused two of its psychiatrists of potentially breaking federal and university conflict-of-interest rules by failing to fully report huge fees from drug companies.

A first-year Harvard Medical student tells the Times:

Before coming here, I had no idea how much influence companies had on medical education. And it's something that's purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.

But there's another faction that thinks industry funds have gotten an unfair rap, and it insists that they're a necessity. The medical school's new dean, Dr. Jeffrey Flier, seems to agree to a certain extent. According to the Times, Flier doesn't want to "tighten the spigot" on industry money: "One entirely appropriate source, if done properly, is industrial funds," he said.

But Flier also "wants Harvard to catch up with the best practices at other leading medical schools." He recently formed a 19-member committee to "re-examine" Harvard's conflict-of-interest policies, which the Times says currently do not require faculty members "to report specific amounts received for speaking or consulting, other than broad indications like 'more than $30,000.'" Nor are there "limits on companies' making outright gifts to faculty -- free meals, tickets, trips or the like."

On the other hand, Harvard Medical School does require all professors and lecturers to "disclose their industry ties in class -- a blanket policy that has been adopted by no other leading medical school."

The committee examining these policies will meet on Thursday, but any suggestions to sever the school's ties with industry will likely meet a wall of opposition. The school's Web site has this to say on ties between "biomedical research institutions" and the industry: "The Harvard Faculty of Medicine remains strongly committed to continued growth in these innovative and mutually beneficial relationships." In other words, they're probably not going away any time soon.


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REPORTING THE TRUTH AT CAMP PHARMALOT

Ed Silverman's work first appeared on my radar a few months ago when I discovered his terrific blog called "Pharmalot." Pharmalot is SO credible because Silverman has made pharmaceuticals his specialty. He is a “big picture” reporter — and his years of experience have enabled him to cut through the bull to report only the facts.

Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey for 12 years, but his six years with Newsday and another stint at Investor’s News Daily obviously helped shape his journalistic prowess. In the past few days alone, he has reported on the NIH and their own Financial Conflicts Of Interest, how drug maker AstraZeneca “Knew Seroquel Risks For Years,” and perhaps most shockingly, in reports from Australia, that “nearly 4,000 children under the age of 10 were prescribed antidepressants last year, including 553 children under five and 48 babies, even though no antidepressant is approved in Australia for the treatment of depression in children and adolescents.”

According to his website, Silverman has been investigating all aspects of pharmaceutical manufacturing, including, “drug development; mergers and acquisitions; regulatory oversight; safety and pricing controversies, and marketing issues” — and it shows.

Day after day, week after week, Silverman has revealed the kind of insightful information one really needs to be an informed consumer. On Nov. 26th, Silverman wrote, “we learned that reknowned Harvard University psychiatrist Joseph Biederman pushed Johnson & Johnson to fund a research center at Massachusetts General Hospital that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use.” This is same class of drugs that has been exposed for causing diabetes — a fact documented in GENERATION RX during my interview with another famed Harvard psychiatrist, Dr. Alvin F. Poussaint.

Recently Silverman posted another article on the site at HealthJournalism.org that the British Medical Journal (BMJ) was upset “when the UK media reported results of a study about the effects of caffeine in pregnancy - before BMJ had a chance to publish online.” This outrage came despite the fact that the subesequent stories only involved caffeine, which is hardly as dangerous as most mainstream medicines. Officials at the World Health Organization (WHO) also displayed their anger with the New York Times for publishing a story about measles when the information was supposed to be embargoed. This “gentleman’s agreement” between journalists and the agencies they cover prompted the following reply by me on their website:

“The fact that WHO punished The New York Times after breaking an embargo on a story about measles only points to how far the journalistic community has fallen over the past few decades.

Since WHEN has it been acceptable for journalists to be so closely aligned with WHO? Ditto the BMJ and New England Journal of Medicine!! Too many reporters have lazily become "part of the system" and look at their insider's connection as a competitive edge.

WRONG. What this mentality has fostered is nothing more than an "Inside the Beltway" mentality, where too many health reporters take the PRESS RELEASES doled out by NIH, NIMH, FDA, NEJM, WHO etc etc etc — and print them as Gospel truth!

As Mr. Silverman has pointed out repeatedly, this kind of uncritical acceptance of "the state of healthcare" from those who have financial and vested interests is a big part of the problem.

As I have shown in my recent film GENERATION RX, scores of people are dying — and scores of children are being prescribed drugs that have NEVER been proven to work better than placebo.

It is only recently coming to light, but why aren't there more journalists challenging the drug companies and the aforementioned agencies? Why aren't more of you digging for the truth?

Look in the mirror. Times are tough all over. But if you deliver the Truth after years of lies you will be able to distinguish yourselves from the rest of the pack.

In my opinion that's what Gardiner Harris of the New York Times has done, along with Ed Silverman.”

IN THE CRITICAL QUEST FOR HEALTH INFORMATION, we all face the same obstacles. Without journalists who are willing to dig for information — without the few courageous souls who willingly stand up to government agencies and the drug makers, we are lost. Make no mistake: it is difficult to find — and report on the truth.

Amid the horde of questionable reporting, there are indeed journalists who ooze integrity — men and women who challenge the Press Releases being poured forth into the mainstream media every day.

So do yourself a favor. Visit www.Pharmalot.com and explore the work of Ed Silverman. As I’ve written many times, each of us needs to be armed with the truth so we can make informed choices about healthcare.

Ed Silverman and Pharmalot represent that truth — and the finest journalism has to offer.

A LETTER OF THANKS TO THE DRUG COMPANIES

Dear Pharmaceutical Executive:

Our daily sales statistics for Generation RX reflect that consumers worldwide are flocking to the film. They also tell another story: the drug companies are also buying my film!

I am writing today in order to discern whether you were aware of this, or whether was it a simple clerical error. Good help is so hard to find these days! Our records show that on the first day the DVD was officially available for sale online, more than a dozen copies were purchased either by a drug company or in one case, their public relations firm.

And that’s only on the first day!

As the Director of the film, I am writing to thank you for your enthusiastic support of my vision. Please know that I appreciate your best wishes — and have told many national reporters — and Senator Grassley of your generous act.

At first, they didn’t believe me, but I told them that it was indeed a magnanimous gesture on your part. I mean, to purchase the work of filmmaker who has worked so diligently to expose the shoddy science and conflicts-of-interest that has permeated the medical establishment, well, it makes me beam with pride that you are taking my work so seriously.

Was I all-wrong about you? With the purchase of GENERATION RX, are you now trying to get to the truth? Am I to be accorded the official blessings of the entire petrochemical universe from this day forward?

If so, thanks again. Wow. You guys sure are great.

If I may be so bold, I’m sure that if ALL of your employees were ‘asked’ to buy my film, then I could get started much sooner on my next documentary, which involves the entire history of your great industry, dating back to Germany in the 1930s.

Ah, the stories we’ll tell!

So please write back when you get the chance, and let me know whether we should process the credit card for your orders. We take everything but Diner’s Card.

In the meantime, please accept my thanks for stepping out front to buy my film. Your support means the world to me!

Yours sincerely,

Kevin P. Miller
WRITER/PRODUCER/DIRECTOR

DANCING WITH THE PORCUPINE

GARDINER HARRIS IS A MAN ON A MISSION — one aimed at uncovering the truth about conflicts-of-interest between the drug companies and the psychiatric medicine machine. In the past year, his sterling reporting for the New York Times has given collusion and corruption in psychiatric medicines the kind of intense national scrutiny missing for decades.

It is extremely gratifying to know that my film GENERATION RX — which delves deeply into the issue — will not be left twisting in the wind all alone. Mr. Harris’ reporting confirms yet another basic tenet of my documentary: conflicts-of-interest not only do exist, but they are pervasive, and run throughout the mental health community.

Today Mr. Harris revealed another shocker: the host of National Public Radio’s popular show “The Infinite Mind,” a program that has won in excess of 60 journalism awards, has accepted at least $1.3 million from the drug companies for marketing lectures. And that is only since the year 2000. Mr. Harris reports that Dr. Frederick K. Goodwin, the psychiatrist and radio host, “is the latest in a series of doctors and researchers whose ties to drug makers have been uncovered by Senator Charles E. Grassley, a Republican from Iowa.”

During my interviews for GENERATION RX, Professor Sheldon Krimsky of Tufts University detailed how funding cuts in Academic research during the Reagan years helped precipitate this “blurring of the line” between academic/scientific research and commercial interests. “What they (the Reagan administration) thought they would do is to create a closer linkage between the corporate world and the academic world,” says Krimsky. “So they created incentives for corporations to invest in universities. At the same time, they kept proclaiming that . . .the federal budget was going to be mean and lean, and that got university administrators very concerned. How were they going to make up the financial downfall in the university budget?”

University presidents, Krimsky pointed out, were now between a rock and an economic hard place, and opted for survival “by creating this new era of commercialized academia.” It soon became acceptable for scientists to have a commercial affiliation while being paid as a basic researcher. This changed the ethos of science, perhaps forever.

In the old days — and by ‘old’ I mean the 1970s — academic and journalistic interests worked hand-in-hand to root out the best of scientific research. Integrity of the information was paramount — in fact, it was the stated goal. During that era, skepticism was a hallmark of the academic mission. It kept what some brilliant Canadian conflict-of-interest researchers called “the premature enthusiasms of industry,” in check.

As Gardiner Harris and other journalists have discovered, those safeguards were abandoned years ago. GENERATION RX puts forth many of the shocking details, but Sheldon Krimsky knew all of this would come to pass, sooner or later.

He tells viewers how there are two rules that operate within the federal advisory committees, the groups responsible for making recommendations on whether any given drug should be available to consumers. “Rule number one says that anyone who has a substantial conflict of interest cannot serve on a federal advisory committee,” Krimsky says with a knowing smirk. “Rule number two says that rule number one can be waived. And rule number one is waived; in some cases the evidence shows 50 percent of the time.”

So there you have it. The very rules written into law to protect the public from conflicts-of-interest actually make allowances for the rules to be broken half the time. “One culture’s pursuit of the truth is supposed to be unencumbered by money,” Krmsky concludes, “and the other culture, for which money is the medium of exchange, is the bottom line.”

The Canadian conflict-of-interest researchers recognized this ethical landmine as the most dangerous and daunting challenge for today’s academic research programs. In fact, they coined the perfect term to decribe what it is like when academia and the pharmaceutical companies are joined at the hip.

They call it, “Dancing with the Porcupine,” a term meant to describe the steep and painful price we all pay when the cherished institutions we rely upon for truth — go awry.



E

GENERATION RX Reveals Widespread Ethical Conflicts, Risks of Psychiatric Drugs to Children

GENERATION RX documents how an entire era of children have been caught in the middle of an unprecedented change in Western culture: that of drugging children with psychiatric medications earlier—and more often than ever before. Writer/director Paul Haggis, who won back-to-back Academy Awards® for "Million Dollar Baby", and "Crash," calls GENERATION RX "a powerful and often chilling eye-opener. Many of the stories stayed with me weeks after viewing — and continue to haunt me now."


Cleveland, OH (PRWEB) November 11, 2008 -- International award-winning filmmaker Kevin P. Miller announced today that his new film, GENERATION RX will be released on Tuesday, November 11, 2008 through the film's website at www.GenerationRxFilm.com.

GENERATION RX addresses many of the alarming issues surrounding the growing use of ADHD drugs, antidepressants, and anti-psychotic medications among children and teenagers worldwide.

"For decades, scores of doctors, government officials, journalists, and others have extolled the benefits of psychiatric medicines for children," said Miller, the film's writer and producer. "GENERATION RX unveils 'the rest of the story' and explains how this era of unprecedented change in Western culture really occurred -- and what price has been paid by society."

By employing the expertise of internationally respected professionals from the fields of medicine, ethics, journalism, and academia, Kevin P. Miller investigates whether collusion between drug companies and their regulatory watchdogs at the FDA exists. He also focuses on the powerful stories of real families who followed the advice of their doctors -- and faced devastating consequences for doing so.

GENERATION RX is a film about families who confronted horror and found nowhere to turn for help -- and how scores of children have been caught in the vortex of mind-bending drugs at the earliest stages of their growth and development. This powerful documentary also examines whether we have forced millions of children onto pharmaceutical drugs for commercial rather than scientific reasons.

Ultimately, Miller says, "GENERATION RX may help parents decide whether the perceived benefits of these medications outweigh the serious risks to children."

Critics and Hollywood insiders have already begun hailing GENERATION RX as one of the best documentaries of 2008. Paul Haggis, the Academy Award® winning Writer/Director said, "Generation RX is a powerful and often chilling eye-opener. Many of the stories stayed with me weeks after viewing — and continue to haunt me now." Mike Adams, publisher of NewsTarget and Natural News, says the film "delivers a jaw-dropping emotional ride," and "weaves a terrifying tale of criminal conspiracy. It is one of the best films of 2008."

Jason Buchanan of the "All Movie Guide" stated, "GENERATION RX is a film that every parent should see."

GENERATION RX is being released by Common Radius Films, an Independent media company based in Vancouver, British Columbia. For more information -- or to obtain a copy of the film, visit the movie's website at wwwGenerationRxFilm.com.

The documentary film trailer can be viewed on YouTube at http://www.youtube.com/watch?v=awXu9v8ervc

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