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Drug safety 101.

This is Part Two in an editorial series dealing with pharmaceutical companies. Part One can be found in Nutrition Health Review #84).

If you have ever had any sort of health problem--anything from high blood pressure to a few sneezes in the springtime--chances are you have encountered a prescription drag with a familiar brand name. If your physician has ever examined a patient with any sort of health problem, chances are he or she is familiar with a certain brand name, as well. Both of you may feel comfortable and confident with the brand name, but only one of you is on the drug maker's payroll.

Every day in America, physicians blur the line between unbiased healers and corporate shills. Their intentions may be noble, but the subconscious grasp of the pharmaceutical industry may be putting your life and the lives of your loved ones at risk. It is not uncommon for a pharmaceutical company to stage elaborate seminars that are no more than multi-million dollar, disingenuous, infomercials. For example, at a recent convention of the American Psychiatric Association, 14,000 doctors flooded Philadelphia

in order to "learn" about the latest drugs for their patients.

One exhibit put on by Janssen Pharmaceutica, whose drug Risperdal[R] (risperidone) is used to treat schizophrenia, set up a virtual reality "bus" that was designed to show psychiatrists how a patient with schizophrenia feels. Apparently, the many years spent in medical school had not prepared them to deal with this relatively common disease. The idea, as described by Janssen, is that the "rider" on the bus is supposed to be a patient who has gone too long without his or her medication. The bus' destination, according to the exhibit, is the pharmacy. Voices call out from all sides, the bus appears to swerve, and the visual images become distorted. At the end of the ride, the virtual bus driver looks at the rider and says, "Hey, you don't look so good; maybe you should have gone to the pharmacy sooner."

These perks have raised the eyebrows of both the American Medical Association (AMA) and Congress, which continually review the AMA's 12-year-old ethical code of accepting girls. The leeway offered by these ethical codes, however, is astounding.

Doctors are often made "advisers" to pharmaceutical companies, sometimes for as little as a few hours at a time. As advisers, they are able to receive large payments and travel expenses. Forest Laboratories, Inc. calls its bankrolled physicians "advertising/marketing consultants" in their confidentiality agreements.

Physicians are not machines. If presented with free food and activities, no one could begrudge them their willingness to accept. It is the fact that they leave these conventions and events with a tendency, albeit a possible subliminal one, to prescribe first a medication with an unclear safety record that may be fresh in their minds that puts patients at risk. In addition, the patients may already be at risk because of the barrage of cartoonish advertisements they are confronted with each day.

The power money has over certain doctors is certainly nothing new. Dr. Morris Fishbein was appointed head of the AMA in 1924 after failing anatomy in medical school and without ever seeing a patient. By 1934 he assumed complete control of the company and made life very difficult for doctors who did not wish to join. In addition to his dictatorial control over licensing boards, he bullied a young inventor named Royal Raymond Rife into bankruptcy after Rife was using a successful treatment for cancer that would have ultimately put a lot of doctors out of business. Dr. Fishbein vandalized Rife's equipment, destroyed his laboratory, and confiscated fifty years worth of research. Researchers today are still trying to replicate Rife's results, but as of yet they have been unsuccessful.

Dr. Fishbein also decided which drugs could be sold to the public based on how many advertising dollars were funneled into the Journal of the American Medical Association. Using the leverage of this prestigious journal, he extorted as much money as possible from pharmaceutical companies. Drugs were not always sufficiently tested; the decision to sell to consumers was largely based on Fishbein's opinions.

The tyrannical hold of Dr. Fishbein has long since ended, and the system of checks and balances within the pharmaceutical industry has made for a much safer consumer market, but the question still remains as to why the AMA still offers a fellowship named after Dr. Fishbein. Buildings are still dedicated in his honor to this day as well. Is this a glimpse into the true value system of the pharmaceutical companies?

Another potential ethical dilemma lies with direct-to-consumer (DTC) pharmaceutical advertising. DTC is a multimillion dollar industry designed to inform consumers about certain drags that can be used to treat whatever ailment they have or think they have. Generally, these ads paint a picture of utopian living following the ingestion of tiny, bright-colored pills. Serene settings and broad smiles are the norm, followed by a speedy, breathless, and incomplete recitation of side effects. It would be ridiculous to expect that that an ad for a certain drag focus on its potentially fatal risks, but these omissions could put a greater strain on doctor-patient relationships.

The fact is that there is a fairly decent chance that the brand-name drug you see in a magazine or on television is just a copy of an older drug that has an expired copyright. After a particular patent has lapsed, other pharmaceutical companies can sell their own version of the drug under a generic name at a much lower price. Drug companies get around this potential loss of profit by patenting a new drug that may have one or two different inactive ingredients, marketing it as a "next-generation" drug, and keeping their bottom lines nice and fat. It is necessary to research all potential prescriptions in order to be certain that you are not falling for some complex sales pitch:

In addition to the danger of drastically overpaying for prescriptions, many people are also taking drugs that they assume are completely safe. It is common knowledge that the FDA approves all drugs prescribed in the U.S. for sale, and it is assumed that the FDA does all of the testing on these drugs itself.

That is not true. With the seemingly never-ending supply of new drug applications, coupled with the long periods of time required to adequately test all of these drugs for long-term safety, it would be impossible for one agency to keep up with an entire nation's demand. Therefore, pharmaceutical companies themselves are left with the task of testing their own drugs for safety and then submitting the results to the FDA for proper review. The FDA looks at the data and decides whether the drug company has shown that the medication is effective and without serious side effects. There is no comparison made between other drugs used for similar purposes in order to decide which one is safer for consumers.

The FDA, like any other federal regulatory office, is made up of many people who intend to one day work in that particular industry, which means that the person reviewing a drug manufacturer's new medication may one day find themselves lobbying for a job at that same company. That person will be armed with a thorough knowledge of what the FDA is specifically looking for with regard to drug approval, therefore making him or her a valuable potential employee to any pharmaceutical company.

This "honor system" is not working. The Scirex Corporation recently admitted that nurses in its testing laboratory cut comers during drug trials and attempted to cover their tracks. The nurses gave medication to patients in four clinical tests and then sent them home before the eight-hour trial period expired. They then reported observations allegedly made during the full eight-hour test.

Pharmaceutical companies have also had to do their share of explaining to their own shareholders in recent years. In 1999, it was revealed that Merck never actually collected 10 percent of its claimed revenue. A class action lawsuit was filed on behalf of purchasers of Merck securities. Bristol-Myers Squibb, another pharmaceutical giant, has been investigated by the Security and Exchange Commission (SEC) concerning the incentives offered to wholesalers to take stock in order to meet sales figures. Yet another pharmaceutical company, Elan, has also had its accounting policies investigated.

If the companies are willing to lie to their own investors, bribe the physicians who drive their profits, and tailor their research to fit a need, how can you be sure that you are getting what you need from those little colorful pills?
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Publication:Nutrition Health Review
Geographic Code:1USA
Date:Mar 22, 2003
Previous Article:Parental pressures and suicidal thoughts.
Next Article:Adults aged 63 to 90 years who wear bifocal. (Postscripts).

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