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Posts Tagged ‘big pharma’

How to Manufacture a Disease

Posted by Admin on December 27, 2010

http://inthesetimes.com/article/6740/

By TERRY J. ALLEN

Disasters can spark lawsuits. Faced with litigation, pharmaceutical corporations must cough up data—and sometimes choke on it.

After the FDA approves a new drug, it rarely faces follow-up studies that might reveal serious and possibly fatal side effects. Some dangers remain hidden for years until an accumulation of disasters sparks lawsuits. Faced with litigation, corporations must cough up data—and sometimes choke on it.

A suit against drug maker Wyeth freed 1,500 documents that yielded “unprecedented insights into how pharmaceutical companies promote drugs,” wrote Adrianne Fugh-Berman in a September study in PLoS Medicine. The 14,000 plaintiffs who took the menopausal hormone therapy (HT) Prempro claim that Wyeth distorted study results and hid evidence of harm. Some patients traded the temporary inconvenience of hot flashes for the permanent inconvenience of death.

It was not as if Wyeth didn’t have reason to suspect serious risk. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use. To counter this side effect, Wyeth added progesterone and created Prempro. But the new combo not only failed to prevent cardiovascular disease, it increased the risk of breast cancer, stroke, dementia and incontinence, according to the 2002 Women’s Health Initiative study.

For decades Wyeth had promoted HT and the diseasification of menopause through tried and true schemes: First, it redefined a normal process—in this case aging and menopause—as an illness treatable with drugs. After cherry picking studies, some conducted off-shore, it hired specialized companies to ghostwrite favorable articles for medical journals, and paid doctors to sign their names—thus creating the impression that independent researchers, not hacks-for-hire, had authored the articles.

“Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ‘benefits’ of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles,” Fugh-Berman concluded.

DesignWrite, Wyeth’s hired ghostwriting outfit, boasts “long experience in blending scientific and clinical issues with marketing needs.” It cranked out more than 100 articles and presentations for journals and symposia touting Prempro’s virtues, and then paid prominent doctors and researchers who contributed little more than their names.

A particularly lucrative medical market, with a history of recalls and scandal, is the $200 billion U.S. medical device industry for replacement joints, pacemakers and CT scanners. Fugh-Berman’s study of conflicts of interest, using disclosures forced by government investigations, revealed that in the year ending in January 2009, five medical device companies doled out 1,654 payments to orthopedic surgeons and researchers that totaled more than $248 million. Fewer than half the experts who published articles dealing with the “donor” company’s products disclosed their financial relationship.

Big pharma’s stake in cooking the books is obvious, but why are medical journals complicit? One reason is that unlike most of the web, most medical journal sites protect their material behind a sturdy pay wall, and may charge up to $40 per reprint. Drug companies sometimes buy up thousands of product-favorable reprints to distribute free to doctors, thereby providing a cash incentive to journals that publish articles likely to be reprinted.

If journal articles are insufficiently laudatory as marketing vehicles, drug companies can turn to supplements. Separately bound, these publications bear the journal’s name, but are industry produced and rarely peer-reviewed. Wyeth, for example, mailed its pro-Prempro supplement with the journal Women’s Health in Primary Care to 128,000 physicians.

In 2000, big pharma firms spent more than $15.7 billion promoting prescription drugs in the United States. Like other mega corporations, they have great advantages over citizens: They are rich, powerful, protected by laws and tax rules, and given the rights of people while shielded from many of the responsibilities. On our side, we have timid or weak politicians and bureaucrats, activist organizations and the ability to sue. Unfortunately, lawsuits tend to punish rather than prevent. But the deterrent effect of large settlements, the bad PR and the discovery of data and records are nonetheless components in mitigating the epidemic of corporate greed.

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Terry J. Allen, an In These Times senior editor, has written the magazine’s monthly investigative health and science column since 2005. how_to_manufacture_a_disease/

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Where the prescription looks like the laundry list!

Posted by Admin on December 9, 2010

Medicine

Medicine

http://www.thehindu.com/opinion/open-page/article931840.ece?homepage=true

PROF. B. M. HEGDE

“All good is hard. All evil is easy. Dying, losing, cheating, and mediocrity is easy. Stay away from easy.” — Scott Alexander

The foundation of modern medical science is shaky. The gold standard of medical science is only statistical, randomised controlled trials (RCTs) used to test drugs and instruments. In short, if there is a science (I have shown elsewhere that there is no science of man), it is just statistical science and does not meet the strict standards of either science or technology as defined by the National Aeronautics and Space Administration‘s Technology Readiness Levels (NASA-TRL) or modern systems engineering (MSE). I have extensively written about the unscientific base of the RCTs in both my books and articles over the past four decades.

Even the President of NICE, which is the highest body to oversee drug research in the U.K., Sir Michael Rawlins, in his Harveian Oration at the Royal College, had this to say about RCTs: “That randomised controlled trials (RCTs), long regarded as the ‘gold standard’ of evidence, have been put on an undeserved pedestal.” Sir Michael outlines their limitations in several key areas, arguing that a diversity of approaches should be used to analyse the whole evidence base. (Rawlins M. The Harveian Oration of 2008, De Testimonio. On the evidence for decisions about the use of therapeutic interventions. Royal College of Physicians, 2008). This is bad news for the conventional thinkers, coming as it does from the highest level in their own backyard.

Using this kind of science, industry tries to exploit the public to make money with all kinds of chemicals passed off as effective drugs! History tells us that Nujol, the useless byproduct of petroleum extraction, was the first anti-cancer drug; and chlorpromazine, (Largactil), used extensively in psychiatry, is a byproduct of rocket fuel extraction! Many of the present expensive anticancer chemicals have not even gone through the inadequate RCT test! Now my friends who hate me for writing that a routine check of healthy individuals is dangerous will understand why I wrote what I wrote. Check-up means labelling, which is followed by drugging or intervening by other means. Most modalities of treatment, using both drugs and surgery, have no scientific base, although many of them seem to work through a very powerful placebo effect. Corrective surgery is an exception.

Most body parameters do change as there is need for them to do so for reasons unknown to us at the moment. Sugar, cholesterol and blood pressures belong to that category. The surest way to get them back to what we think should be the normal is to change our unhealthy lifestyle. Interventions with drugs have a dubious reputation in this field. Lifestyle change is something that is universally useful. Instead of going for a check-up when one is healthy, it is safer to change one’s lifestyle and try to live as close to nature as is possible, keeping one’s mind filled with universal love, devoid of hatred, greed, jealously and anger.

Heavy smokers and alcoholics need check-ups as their body warning signals of diseases fail anyway. The rest of us could make do with seeing doctors only at the first symptom of any change in our body. Symptoms denote the failure of our inbuilt repair mechanism, the immune guard. This also is due to the wrong lifestyle these days.

The pharma industry could go to any extent to fool even the governments to sell its wares. A recent revelation in the Guardian, London, exposed one such heinous act that could have endangered and/or extinguished many lives already. (http://www.guardian.co.uk/society/2010/nov/17/drugs-companies-exorbitant-profits- nhs). The European Union has defined some diseases as ‘orphan diseases,’ where the drug companies are not interested in finding a cure since the financial return might not be attractive. Companies finding out newer treatments for ‘orphan diseases’ would get special incentives from the governments. Please note that the industry is keen only on imaginary diseases (the so-called silent killers) that need lifelong drug therapy; the latter are their cash cows. Blood pressure, sugar and cholesterol are the three biggest milch cows.

It is now discovered that some companies have repackaged some of the old drugs in a new format and called them new cure for ‘orphan diseases’ and have milked the National Health Service of millions of pounds! The Guardian article gives graphic descriptions of the fraud going on. These so-called new drugscould easily pass the RCT test to qualify them as having evidence base. The tall talk of evidence-based medicine is as hollow as are many of our claims to superiority to all other modalities of treatment such as Ayurveda and homoeopathy. In fact, most of them have a better scientific base than our modern medicine. While U.S. medical schools teach for six months, out of their four-year MD course, the basis of other complementary systems, in India, the cradle of the best medical wisdom, Ayurveda, we seem to be averse to teaching anything other than the unscientific modern medicine.

The result is that most of our graduates become good technicians mastering a couple of interventions to make money. The rest of them become researchers, doing RCTs for western drug companies, making tonnes of money in the bargain through the new CROs. One has only to see one of the prescriptions which reads like a laundry list with one beta blocker, one ACE inhibitor, one blood thinner, one sugar lowering drug, of course, one cholesterol lowering drug and many others for every patient.

There is NO science base for this kind of poly-pharmacy, not even the imperfect RCT to back such practices. Recent studies show that patient compliance with such poly-pharmacy is less than 23 per cent. Seventy seven per cent of the recipients are, therefore, safe as they forget to take those tablets! God alone can save mankind from human greed, which has invaded every sphere of human activity ranging from 2G spectrum to patient care. “Do not make money in the sick room,” wrote Hippocrates. We take our oath in his name when we graduate only to become hypocrites in later life! “It is double pleasure to deceive the deceiver.” — Niccolo Machiavelli

(The writer is a former professor of cardiology, Middlesex Hospital Medical School, University of London, and former Vice-Chancellor, Manipal University. email: hegdebm@gmail.com)

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Big Pharma researcher admits to faking dozens of research studies

Posted by Admin on February 20, 2010

Big Pharma researcher admits to faking dozens of research studies for Pfizer, Merck (opinion)

Thursday, February 18, 2010by Mike Adams, the Health Ranger
Editor of NaturalNews.com

(NaturalNews) It’s being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.

Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. There’s only one problem with all this: No patients were ever enrolled in the study!

Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.

It wasn’t the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.

As a result of Dr. Reuben’s faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben.The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years. (http://www.theday.com/article/20100…)

Business as usual in Big Pharma

What’s notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It’s not the fact that so-called “scientific” medical journals published his fabricated studies. It’s not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.

The real story here is that this is business as usual in the pharmaceutical industry.

Dr. Reuben’s actions really aren’t that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.

Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn’t operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.

Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben’s faked studies even though this journal claims to be a “scientific” medical journal based on peer review. Funny, isn’t it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.

Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on “good science.” It’s all scientific and trustworthy, they claim, while accusing alternative medicine of being “woo woo” wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that’s based largely on fraudulent research, bribery and corruption.

More at http://www.naturalnews.com/028194_Scott_Reuben_research_fraud.html

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