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Duty to Warn:

The “Precautionary Principle” Has Been Killed Off:

 Implications for Patients Involved in the Big Business of Medicine

Gary G. Kohls, MD

The time-honored Precautionary Principle says that an ethical business, governmental agency or culture should err on the side of caution before new chemicals, technologies, procedures, services, food additives, drugs, surgical procedures, etc are introduced into the marketplace (and the environment) – and only then when there is absolute proof that the substances are effective and not dangerous to the environment (which includes human/animal life, the water supply, the soil and the air – ie, the future of the planet).

Therefore, in the case of medicine, when a new product that has the potential to adversely affect human health and happiness (even years or decades into the future) is proposed for marketing, the Precautionary Principle requires that adequate and aggressive long-term studies (funded by agencies totally independent of whatever Big Business is intending to market the product) be undertaken and then only released into the environment when it is proven to be totally safe (and effective). 

So the regulatory agencies of governments must aggressively withhold the marketing approval of potentially carcinogenic, disease-producing, neurotoxic or immune system-destroying products from the environment where they will be inadvertently ingested, inhaled or absorbed through the skin of potential victims. And ethical individuals, small businesses and major corporations, must uphold and endorse such precautions.

Therefore, before potentially dangerous products are allowed onto the grocery store shelves or into eating places, pharmacies, hospitals, clinics and into our bodies, the Precautionary Principle says that they should be absolutely proven to do no harm, short-term or long-term.

Scandalously, in America, the Precautionary Principle seems to be dead.

Can You Say Cocaine, Amphetamine, Methamphetamine, Ecstasy, Thalidomide, Thorazine, Haldol, Fen-Phen, Valium, Baycol, Vioxx, etc, etc?

The above list of drugs is a very short list of drugs that were at one time approved by the FDA in America and celebrated in the marketplace as huge money-making block-buster drugs but that are now either discredited as lethal or otherwise dangerous and/or banned outright, all because careful long-term studies were not done. And, of course, the short-term, narrow-focus studies that had been done to obtain FDA marketing approval in each of these cases were funded, designed and published (and the statistics often “massaged”) by employees of the for-profit corporations in whose interest it was to have the drugs reach the market as soon as possible, with instructions to their legal departments to get ready to defend against the inevitable lawsuits when patients start recognizing that they are being sickened or dying from the unintended, unpredicted, toxic effects of the drugs.

The Oath of Hippocrates. Is it Obsolete or Just Forgotten?

We physicians swear some version of the Oath of Hippocrates at the time of being awarded our degrees from medical school. Basically we promise to abide by the oath that commands us to prescribe nothing harmful to our patients – Primum non Nocere ("first do no harm”).

But it only takes 2 minutes to write a prescription, and it takes 20 minutes to not write a prescription. In my ultra-busy, short-staffed clinic, I often don’t have a choice but to do the expedient thing and write the script.”

Most physicians that I have known, including myself, know what that quote is saying (and our patients understand it also) and most of us hate having to do the expedient thing.

Most of us doctors took the Hippocratic Oath seriously in the early stages of our careers, but had no choice but to gradually compromise our ethics because of the frenzy of 1) needing to be maximally productive in order to pay off our $100,000 medical school debt; 2) succumbing to the frustration of trying to do what patients expect and deserve, ie, practicing thorough, non-hurried and curative medicine while simultaneously being double-booked by our clinics (thus not being allowed adequate time to what we really want to do); 3) having to get most of our continuing medical education credits from courses “generously” subsidized by the pharmaceutical industry; and then, 4) being seduced daily by the pharmaceutical  industry’s very attractive opposite-sex sales reps, bearing gifts of “pens, pizzas and post-it notes” in their efforts to get us to uncritically adopt, as a community standard, the use of potentially toxic synthetic chemicals not yet proven to be safe or even effective long-term.

It is often said that the real clinical trials start when the short pre-marketing trials are over and when millions of unsuspecting patients get their first prescriptions.

Big Business argues that the profitability of their enterprises depends on getting new products into the marketplace as quickly as possible and that paying for thorough, independent long-term studies (especially with watchdog agency oversight) is infeasible, not to mention unacceptable for their shareholders.

Duty to Warn: Let the “Buyer” Beware

In light of the current corporate reality, the onus seems to be on the consumer, but it is also, in the case of the practice of medicine, the duty of physicians to warn about the dangers of the drugs we prescribe. We are obligated to fully inform (invariably impossible for new drugs) the recipients of the prescribed chemicals about their long-term safety and efficacy. And the duty of the patient is to engage in the time-consuming effort to be fully informed.

Patients deserve to know that the drugs they might not be able to get off of (as in the case of many psychotropic drugs) are not dependency-inducing (ie, won’t cause withdrawal symptoms), that they won’t be sickened by the drugs and that the drugs are more effective than the potentially curative, non-drug approaches to ill health that can often be used: nutritionally-based, life-style alterations, approaches that are often falsely discredited by the very big corporate “healthcare” industries that are always looking for ways to cunningly eliminate the competition.