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Pfizer Guilty of Racketeering
The Corruption and Failure of Evidence Based Medicine

by Glen Emerson Morris
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Just months after having been given one of the largest fines in American history, Pfizer was again in court over its marketing practices, this time losing to a RICO conviction. Pfizer was sued by Kaiser for misrepresenting the benefits of Neurontin. Pfizer claimed it was useful in treating neuropathic pain with minimal side effects. In truth, the company's own research proved the drug was no more effective than placebos for neuropathic pain, and the side effects could be severe and sometimes fatal.

A Kaiser lawyer declared the trial a victory for evidence-based medicine over marketing based medicine. In fact, he was wrong on two counts. For practical purposes, evidence based medicine is marketing based medicine, and if this case is any example, it is clearly a failure, not a success.

What wasn't fully explained at the trial was how Pfizer's marketing department had persuaded so many Kaiser doctors, for so long, to keep prescribing pills to patients had no more effect than a placebo, but did have significant and dangerous side effects. The answer is that question involves more than just a marketing department with a huge budget and no ethics. Critical to the answer is how Pfizer's marketing department figured out how to game the “evidence based medicine” system, and did they ever.

The phrase “evidenced based medicine,” is to the Pfizer scandal as the phrase “mark to market accounting,” is to the Enron scandal.

For those not familiar with the concept of “evidence based medicine,” it will help to know that it was developed by health plan administrators as a cost reduction control, not by doctors as a process for improving treatment. Previously, for patients not responding to the officially approved medications for their medical condition, doctors might try any of several drugs to moderate the symptoms, even if the medications didn't address the underlying cause. Evidence based medicine stopped that practice by limiting doctors to prescribing only drugs clinically proven to be effective (though not necessarily approved by the FDA) for any given medical condition. No clinical trials, no prescription.

Evidence based medicine saved health care providers millions of dollars, but it also left countless patients unable to get relief from serious medical conditions. Doctors told their patients that their previous positive experiences with medications didn't count as real evidence, but were merely anecdotal evidence, and not relevant to their medical condition or its treatment. Only “properly done studies” counted as evidence, doctors now said, and many doctors actually believed it. Especially those doctors who wanted to keep their jobs.

As evidence based medicine became common doctors increasingly became dependent on drug company studies, and drug company representatives, to provide them with the “evidence” they needed to base treatment plans on. Pfizer and the other drug companies understood this, and went even further by generously funding studies, and making doctors holding strategic medical positions their paid consultants and paid speakers. The drug companies found that it was easy to manipulate the medical system.

Once a drug has been approved by the FDA to treat one medical condition, it's fairly easy to get it approved to treat some other medical condition. It's even easier to quote in-house drug company studies to doctors to promote a drug's effectiveness for off-label use and not bother to get FDA approval at all. All a drug company needs to do is to sponsor a few low cost limited clinical studies, share the best results from the studies with the doctors, and pretend the studies that produced negative results never happened. As long as the sharing is called “educating” and not “promoting,” and the information is valid, the process is legal. Legal, however, is not the same as safe and effective.

As early as 1992, a report comparing treatment options for hypertension (the ALLHAT report) indicated there were signs something was seriously wrong with the medical system. Increasingly, doctors were replacing older low cost, proven safe medications, with newer drugs of questionable effectiveness and an increasing risk of serious side effects.

An article in the Wall Street Journal at the time questioned whether marketing hype was causing effective generics to be overlooked. The article quoted Dr. Robert Califf as observing, "You'd like your doctor to recommend what is best for you based on knowledge, not on what a drug company sales rep told him." The Journal also noted that drug companies push branded drugs through funding of CME, patient advocacy groups, and marketing campaigns, all of which stopped for diuretics when they began to go off patent.

Big Pharma's strategy was effective. A story in dailyfinance.com estimated that in 1994, a year after Neurontin first came on the market, 15% of its sales came from off-label use. By 2002, off-market sales were 94%, or $2.12 billion, of total Neurontin sales. This means that Pfizer was making over $2 billion a year selling a drug that had not been proven safe or effective to the FDA for the illnesses for which it was being prescribed.

In May 14, 2004 the San Francisco Chronicle reported that Warner-Lambert, a division of Pfizer and Parke-Davis's parent, "admitted that it aggressively marketed [Neurontin] by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal" and would pay $430 million dollars in penalties.

Then, in September 2009, pharmaceutical giant Pfizer reached an agreement with the Justice Department to pay a $2.3 billion dollar settlement over the company's illegal promotion of its now-withdrawn painkiller Bextra. The Pfizer lawsuit settlement marked the largest healthcare fraud settlement in the history of the Department of Justice.

Months later, Pfizer was found guilty of racketeering over its off-label practices for Neurontin and ordered to pay Kaiser $141 million dollars in damages.

Unfortunately, Pfizer's RICO conviction is not likely to be the last chapter America's Big Pharma scandal.

After nearly twenty years of marketing based medicine, our health care industry has been flooded by Big Pharma's propaganda for so long that doctors continue to prescribe medications proven to be useless in multiple court cases.

The greatest damage Pfizer may have caused may have been to the healthcare system itself, and to the science on which it is based. By reinvesting its drug profits in funding many low cost studies Pfizer flooded the medical industry with reports written by doctors with a strong reason to be biased in Pfizer's favor.

Evidence based medicine will only work if the evidence it uses is true and complete. In practice, evidence based medicine is equally based on ignoring feedback from patients and relying on evidence provided by marketing departments with a long history of deceptive marketing practices. It's a prescription for disaster, and we can't say we haven't been warned.



Glen Emerson Morris was recently a senior QA Consultant for SAP working on a new product to help automate compliance with the Sarbanes-Oxley law, an attempt to make large corporations at least somewhat accountable to stockholders and the law. He has worked as a technology consultant for Yahoo!, Ariba, WebMD, Inktomi, Adobe, Apple and Radius.





Copyright © 1994 - 2009 by Glen Emerson Morris All Rights Reserved


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