Experts Conclude Pfizer Manipulated Studies:

New York Times - 8-Oct-2008

The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.

Summary:

• The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.
  
• Pfizer's tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, ''spinning'' negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs' lawyers.
• One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out ''a publication strategy meant to convince physicians of Neurontin's effectiveness and misrepresent or suppress negative findings.''
• Pfizer issued a statement Tuesday denying that it had manipulated Neurontin data, saying ''study results are reported by Pfizer in an objective, accurate, balanced and complete manner, with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study or the country in which the study was conducted.''
• The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.
• In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors.
• Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.
• Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries.

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Here we go yet again.

The story above concerns Pfizer, but they are not alone. Many pharmaceutical companies employ the same strategies, and you need to be aware, especially when watching their well produced television commercials.

For physicians to utilize medications properly, we need to have access to good information. This should include not only positive results, but also the negative results of testing and trials. Physicians need to use their own brains to pore through all the information, and use their instincts to distinguish truthful information from what I will now dub, pharminformation.

In today's health insurance dominated system, patient's are often rushed through their doctor's evaluation quickly. It is easier for a doctor to hand you a prescription and move on to their next patient. It would only take a few more minutes to get to the root cause of your illness, and to formulate other options or treatments, instead of relying on just a prescription. And the more rushed doctor's are, the less time they have to think through the pharminformation. The healthcare system has changed the way doctor's practice, and it has changed the trusting relationship the pharmaceutical industry once had with the public.

Treating the individual and their illness, instead of only their symptom has been my focus since I started my practice. I do not rush through patient visits. You are given the time needed to discuss your issues and to answer follow up questions appropriately. Sometimes that puts me a few minutes behind schedule, and I apologize. But be certain that I will always give you the time you need. A few extra minutes of conversation goes a long way in preventing pharminformation from affecting your health.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Ghostwriters for medical research criticized, reforms urged

By LINDSEY TANNER, AP Medical Writer 27 minutes ago

Two new reports involving the painkiller Vioxx raise fresh concerns about how drug companies influence the interpretation and publication of medical research.

The reports claim Merck & Co. frequently paid academic scientists to take credit for research articles prepared by company-hired medical writers, a practice called ghostwriting. They also contend Merck tried to minimize deaths in two studies that showed that the now withdrawn Vioxx didn't work at treating or preventing Alzheimer's disease.

Merck called the reports in Wednesday's Journal of the American Medical Association false and misleading. Five writers of the articles were paid consultants for people who sued Merck over Vioxx's heart and stroke risks; the sixth testified about Merck and Vioxx's heart risks before a Senate panel. Merck says those connections makes the reports themselves biased.

While Merck is singled out, the practices are not uncommon, according to JAMA's editors. In an editorial, they urge strict reforms, including a ghostwriting crackdown and requiring all authors to spell out their specific roles.

Dr. Catherine DeAngelis, JAMA's editor-in-chief, said those are already policies at JAMA but not at many other journals.

"The manipulation is disgusting. I just didn't realize the extent," she said.

The practices outlined in JAMA can lead editors to publish biased research that can result in doctors giving patients improper and even harmful treatment, she said.

DeAngelis said doctors, medical researchers and journal editors bear some responsibility for those harms.

"We're the ones who have allowed this to happen. Now we've got to make it stop," she said.

Drug studies involve several steps, including designing and performing the research, analyzing the results and writing them up for submission to a medical journal. Pharmaceutical companies sometimes pay for a study but have independent scientists perform all those steps. Sometimes companies and their own scientists are involved in some or all the steps, and those were the studies scrutinized in the JAMA reports.

The articles are based on reviews of company documents from court cases over Vioxx, which was pulled in 2004 because of its heart and stroke risks. Merck agreed to pay $4.85 billion last November to settle thousands of lawsuits.

One JAMA report says internal company data showed in 2001 that Vioxx patients in two Alzheimer's studies had a higher death rate than patients on dummy pills. Merck didn't publicize that "in a timely fashion" and provided information to federal regulators that downplayed the deaths, the report said.

But Jim Fitzpatrick, a Merck attorney, said "it's completely not true" that Merck tried to minimize those deaths. He said a Merck analysis found the excess deaths were not related to Vioxx.

The other JAMA article says one Alzheimer study was designed and conducted mainly by Merck scientists. But when published, the lead authors listed were academic scientists not named in a study draft.

Peter Kim, head of Merck Research Laboratories, said those authors "were intimately involved in the studies." One was New York University Alzheimer's specialist Steven Ferris. He also disputed the implication that he had little to do with the study, and said Merck paid him for his work.

Fitzpatrick acknowledged that Merck has hired outside firms to write drafts of other studies that later list scientists as first authors. In those cases, the scientists are expected to review the manuscript and can suggest changes, he said.

The Alzheimer study was published in 2005 in the journal Neuropsychopharmacology. Its new editor, Dr. James Meador-Woodruff, said the journal's policies have been strengthened to ban ghostwriting.

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On the Net:

JAMA: http://jama.ama-assn.org

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If we did not trust the pharmaceutical industry before, how can we now?

Can we believe the hype and advertising that comes from this industry?

For those of you who know me well, I am not a big fan of medication. I prefer to use the least amount possible, and only after exhausting other options. I always prefer to find the cause of the problems and treat the cause with lifestyle adjustments first.

It sometimes take a little longer to come up with the solution, but it may save you both medication side effects and the cost of expensive medications.

If you think you are taking too much medication, please schedule an appointment so we can truly the assess their need, their benefits and their possible risks.

Always remember, that I work for you! Not for your insurance, not for the government!

You will get individualized and personal care and advice. That is what Family Practice is all about!!

Dr Steven Horvitz

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