In 1962, politicians attempting to put things right in the pharmaceutical sector accidentally created the perfect raw material for drug development, and the basis to transform this raw material into the perfect product. But to complete the perfect market needs one extra element – a perfect consumer. By continuing an innovation put in place in 1951, the prescription-only status for all new drugs, the 1962 regulations did just this.
Initially prescription-only status was a police function introduced in 1914 for drugs of abuse. It was extended to all new drugs in 1951 because these new and effective drugs were thought likely to come with significant risks and doctors as a body would be skeptical of the benefits of new drugs and cautious using them. It was also thought they would be able to quarry the appropriate information out of drug companies about medicines, or otherwise generate the appropriate information to make the use of these unavoidably risky drugs as safe as possible.
From 1951 to 1962, the idea of making new drugs available on prescription only was hotly contested – was it appropriate to treat the citizens of a free country as though they were addicts? The thrust of regulation up to 1962 had been focused on the accuracy of the labeling of over-the-counter drugs. Regulating prescription only compounds broke new ground in 1962, and it is not clear that anyone knew what the likely consequences might be. Nowhere else in the regulatory arena have regulators attempt to constrain the use of products that are sold to a professional body only.
It is clear that in 1962, Congress had no wish to regulate the practice of medicine, but prescription-only status has made this unavoidable. The intrusion of “government” into clinical practice has extended from the thin end of this wedge. It is now common to find administrators who know nothing about medical practice dictating to doctors what the content of clinical encounters must be.
Regulators claim all they are doing is regulating the wording used by pharmaceutical companies that may be misleading to consumers, just as they have done since 1906. But in this case the consumers are doctors and the regulator is undertaking to all but guarantee wording about the compound, written by pharmaceutical companies. Where in fact there is advertising, doctors see authoritative scientific statements.
Before the 1962 regulations were passed, Senator Kefauver noted that prescription only status created a unique market: “He who buys does not order and he who orders does not buy”. The fact that thalidomide had been available over the counter in Germany where its hazards came to light may have influenced the decision making process and allayed concerns about prescription only arrangements. No-one considered the possibility that the risks of thalidomide had come to light precisely because the drug had been over the counter, and doctors had no incentive to hide the risks of over-the-counter drugs.
Linked to the prescription-only status of drugs and the development of controlled trials the regulations also encouraged pharmaceutical companies to develop medicines for disease indications. As ever the thrust of regulation was to enhance safety, and one of the apparent ways to do this was to restrict the use of medicines to conditions that in themselves posed a greater risk than the risk stemming from the chemicals used to treat them so that there would be a favorable risk benefit ratio.
What was not anticipated was that if pharmaceutical companies were restricted to selling medicines for diseases only, one option for them was to begin to convert what had been a series of vicissitudes of everyday life and normal variation in terms of beauty and functionality into a set of diseases. We could all be made diseased and indeed there was no reason why we couldn’t all be given several different diseases. And so we have all become depressed, osteoporotic and have hyperlipidemia (hypercholesterolemia) where otherwise we might have had burn-out, aging bones that could be managed by exercise, and a diet-related issue that is only significant against a background of more important cardiac risk factors. We are all about to get a rash of auto-immune disorders we never knew we had, as back-aches become ankylosing spondilitis, and depression becomes an inflammatory disorder.
For companies an unexpected benefit of this restriction was that they had to learn to speak the language of doctors – diseases. They have learnt to do this to an extent that medicine fails to appreciate. A huge range of vicissitudes have been transformed into illnesses, acute illnesses have become chronic and the moral imperative to treat that is brought to conditions like tuberculosis has been co-opted to the sales of almost any pharmaceutical product for indications no matter how trivial. Where patients might be wary of taking chemicals, they are increasingly faced with doctors attempting to persuade them that this chemical will correct some abnormality and that they are almost duty bound to take it.
Kefauver recognized the risks inherent in third party buying arrangements. These are well-recognized and form a major part of conservative arguments against government involvement in areas such as healthcare. The market will simply not work efficiently if the person ordering doesn’t also buy and benefit from or suffer the consequences of their purchase. If this is not the case, at the very least those doing the buying should be trained in the hazards of what they are doing.
In 1962, it was clear there were risks in such an arrangement even though the third party was seen as an independent professional who most people thought would be working on behalf of their patient, almost to the extent that a pilot flying a plane works on behalf of those entrusted to her care. Since 1962, professional discretion has been all but outlawed and doctors prescribing choices are dictated to them not by market pressure but by a system that mandates the use of the latest and most expensive on-patent medicines, the medicines on which there is the least data as regards safety.
Doctors may be the only significant group of buyers who are not trained in the pitfalls of buying for a third party. Their background means that they do not even realize that they are not trained in an area of huge consequence for them and their patients.
Recent estimates suggest that companies spend over $50,000 per annum per doctors marketing to doctors. This figure could likely be greatly increased if the cost of “scientific” articles were also included in the mix. Doctors in other words are subject to a greater concentration of marketing power than any other group of people on earth. But, just as they know nothing about buying for a third party, so also no doctors are trained to recognize the way companies market to them.
Both doctors and patients fail to realize that doctors are the consumers of medicines and that they consume by putting pills in patients mouths. In so doing they consume without consequences or side effects. Companies fully appreciate this and exploit it. If the patient has a problem, company marketing ensures doctors will have to hand a great deal of evidence suggesting that any problems are part of the patient’s illness rather than a consequence of treatment. Evidence based medicine is deployed to relegate any reports of difficulties from doctors or patients to the status of anecdotes.
Companies also work closely on the psychology of individual doctors, categorizing them in terms of whether they are likely to innovate with medicines, want to adhere to guidelines, or merge with the crowd. The approach to each doctor takes this categorization into account. Doctors rarely if ever know how they are profiled, and rarely if ever realize that the adverts and gimmicks and presentations they dismiss are aimed at others not them, and are indeed working on them in so far as they give doctors the impression that they disregard company promotional efforts. But whatever the orientation of the doctor there is another set of pitches designed for him or her that he is likely inhaling with the air he breathes.
Finally, doctors appear to be more susceptible to the effects of branding than even teenagers faced with choice of designer outfits. This happens because the development of branding feeds into the most powerful bias in medicine. Brands unlike drugs come free of side effects. The temptation for a doctor is to go with the brand, because no-one wants to give a patient something that might injure them. But this is a form of thinking that reduces doctors to playing at doctors and nurses rather than engaging in medicine.
There is some token resistance to using the brand name of drugs in academic articles, but medical textbooks quickly incorporate brands such as SSRIs, statins, and quite meaningless designations such as atypical antipsychotics. More to the point, where academic meetings in the 1950s and 1960s routinely featured symposia on the hazards of using certain drug groups, it would now be as rare as finding snow in the Sahara to find a symposium at an academic meeting today about the hazards of treatment unless the symposium was sponsored by the makers of a competing product.
Quite aside from transforming doctors into the perfect consumer in this sense, in 1962 it was not appreciated how much a mechanism designed to improve safety might in fact do just the opposite by transforming clinical encounters into hostage situations. Making drugs available on prescription only means that patients have nowhere else to go to get a medicine they need or think they need. They effectively become a hostage rather than a patient and risk the development of Stockholm syndrome.
In 1962 Stockholm syndrome had not yet been described. It is now known that people whose lives are at risk and who are isolated (anyone with an illness), when held hostage by kind captors concerned about their welfare (as doctors are increasingly trained to be) are highly likely to identify with their captors and want to keep them happy. In these circumstances, especially when the patient finds their condition worsening, it becomes very difficult to raise the possibility that what the doctor has done in good faith to help might in fact be causing problems.
It seems more and more likely that the safety consequences of turning patients into hostages outweigh the risks inherent in the drugs that doctors prescribe. The evidence that treatment induced adverse events have now become a leading source of death and disability point just this way. Meanwhile there is not a medical course on earth that trains doctors to recognize their capacity to induce Stockholm syndrome.
Someday soon your doctor is likely to suggest Humira for your backache or Enbrel for your ‘nerves’ - or some succeeding biologic drug. Drugs that have triple the reporting rate of serious side effects of antidepressants and antipsychotics. Your doctor will come up with this idea, unaware as to where it came from. He will likely be pleased with the idea of trying something new and he won’t be aware of any discomfort on treatment. You won’t report anything to disturb his equanimity. He might think it prudent to withhold information about cancer and serious infection rates on these drugs in your interest, unaware that “There is simply no constitutional basis for recognition of a right on the part of physicians to control patient access to information concerning the possible side effects of prescription drugs” (1).
He will think he has a right to withhold this information from you and a God-given right to prescription privileges that bring with them annual remuneration rates of several hundred thousand dollars per year. He is the best possible partner any drug company could have, and ideal consumer rolled into one.
1/. Greene J, Siegel Watkins E (2012). Prescribed. p 111. Cite from a ruling in February 1980, by US District Court in Delaware, Johns Hopkins U Press, Baltimore.