Practitioners and the Pharmaceutical Industry

Thomas AM Kramer, MD

Disclosures

Introduction

One of the most contentious issues in the practice of psychopharmacology is the quality of interactions between practitioners and the pharmaceutical industry. The distinction between gifts and bribes, so called "freebies" and buying influence, continues to be debated hotly. This is an enormously complicated issue. There is a great deal of scrambling for the so-called moral high ground, and blanket statements are often made about what is ethical and what is not. Frequent readers of this column are familiar with my favorite Albert Einstein quote; "Make things as simple as possible, never simpler." I am often impressed that the debate over this issue violates Einstein's rather wise saying.

Some aspects of this issue are painfully clear. Pharmaceutical companies spend an enormous amount of money marketing their products. They do not do this because they have extra money that they need to get rid of. They do it because it is effective. Doctors think that they are not particularly influenced by the gifts and the attention they receive. There is an enormous amount of data to the contrary. In summary, pharmaceutical companies have been successful in purchasing the decision-making power of physicians.

There is, to the best of my knowledge, no data that shows that physicians are being influenced to make decisions that are bad for the health of their patients. The issue seems to be that physicians are being influenced to prescribe, at worst, more expensive treatments than necessary and, more often than not, to prescribe one treatment over another when they are equal in terms of efficacy and cost. Claims that patient care is being corrupted by the pharmaceutical industry are an example of being overly simplistic.

Pharmaceutical companies are not charitable foundations. They do what they do to make money for their stockholders. They make no other pretense. As a result, they can act in ways that are not in the best of interest of patients as a whole. Psychopharmacology is replete with examples of this. Perhaps the worst examples are the availability of certain medications. There are medications that may be of great use to us that are currently unavailable because it would not be particularly profitable to market them in this country. The only reversible monoamine oxidase inhibitor (MAOI) currently available, moclobemide, is not available in this country because the pharmaceutical company that owns its patent determined that it would be too expensive to market here. Thus, patients who might respond particularly well to an MAOI have to take one of the older, irreversible ones, which are considerably more dangerous. It would be nice if American psychopharmacologists had the option to use this drug. The antipsychotic sertindole will never be marketed in this country. Although there were some problems with this drug causing significant intracardiac conduction delays (and the FDA was prepared to insist that serial cardiograms be done if the drug were to be prescribed, similar to the serial blood tests for clozapine), I have been told by people who did the initial clinical trials of sertindole that it was particularly effective in some schizophrenic patients who were treatment refractory. It may have offered them the only known hope for a medication on which they could be stabilized. Once again, the pharmaceutical company figured out that it would cost them too much money to make this drug available in this country.

These same forces may soon come to bear to create a new generation of improved antidepressants. Many of the pharmaceutical companies that have been marketing selective serotonergic reuptake inhibitors (SSRIs) held improved antidepressants in their pipeline, delaying their development while they were making enormous amounts of money with the current generation of drugs. Since fluoxetine (Prozac) has now gone off patent, the drug is available generically, and one can anticipate the price will continue to decline. Since the differences between the various SSRIs are scant, and one of them can now be had considerably more cheaply than the others, one can anticipate the number of new prescriptions for on-patent SSRIs to decline. This will provide the pharmaceutical industry with incentive to develop new antidepressants such as selective noradrenergic reuptake inhibitors and more combined reuptake blockers. Looking further to the future, development may be accelerated now for drugs based on peptides such as substance P or neurokinin inhibitors. There was little incentive to do this while marketing a wildly profitable medication. Similarly, recent work has been done to separate out isomers from racemic mixtures of drugs that may be more effective and/or have fewer side effects. Although this work has been going on for quite some time, it is only now beginning to make it to the marketplace -- and some of it never will. This is because the patents on the original racemic drugs are only now running out.

Many practitioners feel that the only way to deal with the conflict of interest of profit-driven pharmaceutical companies vs patient care is to avoid contact with the pharmaceutical companies altogether. There is some sense that any contact or any gift, even a ballpoint pen, represents undue influence. If, and only if, prescribing could be done in a vacuum, then only the priorities of patient care would enter into the decision making. It is certainly true that gifts influence physicians and probably true that larger gifts influence them more than smaller gifts. Ultimately, every physician makes up his or her mind about what is appropriate, and physicians can be put off as easily as encouraged by marketing efforts. We have all seen behaviors from pharmaceutical representatives that were so repugnant that they caused a doctor to promise that he or she would never prescribe their product again.

It is important to note, however, that many marketing efforts made by pharmaceutical companies are quite helpful to patients. Sampling, the practice of giving doctors free medication that they can start patients off with to see whether they tolerate the medication and whether the medication is effective is not only good marketing, but it also helps patients and saves them money. Drug companies sponsor many educational programs, scholarships, fellowships, and other events that often are absurd, weakly camouflaged efforts at marketing but other times can be quite valuable. Once again, the drug companies do not do this because they like giving away money, but often, good causes and good programs can be part of marketing campaigns.

It is the fault of neither the pharmaceutical companies nor the physicians that the relationship can become problematic. We need better rules and guidelines, better dissemination of information about the extent to which physicians are manipulated, and more open discussion of this issue to help us deal with it more effectively. The pharmaceutical industry will continue to devote huge amounts of money to marketing their products. We have an opportunity to influence how that money is spent, and we have done a very poor job in doing so. If specialty societies for physicians would make policy, for example, allowing pharmaceutical companies to fund educational programs but forbidding their product to be featured in any way, we might be more effective in directing the flow of these funds. In short, we need to talk about this even more than we do. It is not a problem that can be solved. It is an ongoing issue for practice.

Finally, the answer to this problem is not to avoid all contact with the pharmaceutical industry. We are dependent upon them to make the agents that we use in our practice. Unless you intend to build yourself an organic chemistry laboratory in your garage and make your own medications, you need them to make the drugs for you. You also need to continue to have an open dialogue with the pharmaceutical industry to let your thoughts and needs be known. We all need to be talking to these corporations about things they need to develop or improvements they need to make in their products. Turning off that dialogue in the name of avoiding a conflict of interest is truly cutting off one's nose to spite one's face.

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