Switching Mevacor to an OTC Drug: An Ethical Dilemma?

What is an ethical dilemma? It is when an ethical issue can’t be easily decided because there is no obvious decision, amongst those that could be made, which would trump the others. To start to make an ethical decision, one must look at each of the stakeholders in the decision and consider the benefits vs. the burdens each decision might create for them. Then based on ethical principles and previous similar decisions, select the one which will be the most beneficial and the least burdensome to all the stakeholders.

How does this apply to the consideration of the switch of Mevacor from a prescription to an over-the-counter (OTC) drug? Who are the stakeholders? Well, they include the general public and particularly those who are at high risk for cardio-vascular disease, the physicians, the drug company, the insurance company and the government. Any others?

What is the ethical issue regarding Mevacor? Is the switch being requested by the pharmaceutical company for their own self-interest or primarily for the benefit of the public? If it is for the former, a decision to accept the switch would, in my opinion, be unethical

What are the ethical principles? I would say that the main stakeholder is the public and that beneficence (doing good to public) and non-malificence (doing no harm to the public) are the main considerations. What would be the benefits to each? For the public, one benefit would be more people would be taking the potentially beneficial drug since the current evidence suggests a tendency toward non-treatment by physicians of appropriate patients with statin drugs, such as Mevacor. There might be a substantial improvement in public health with the documented affects of statins on cardio-vascular disease.
The other benefit would be, in theory, less expensive medication and also they would not, if the person desired, be required to see a physician and pay for a visit and prescription—“self-care”. The benefit for the drug company would be that a drug like Mevacor which was losing it’s patent protection would, as an OTC brand, assure continued income to the company. The benefit for the insurance company and government would be related to the possibility that the drug, if present on their formulary, could be removed and thus save the costs of paying for the drug. Unfortunately, this benefit for the insurance company becomes a burden to the patient in that the OTC drug may actually cost more since the patient will no longer pay only a co-payment but the full charge. If the drug prevents or improves cardio-vascular disease, there will be less of a financial burden to the insurance company and government for paying for care of patients with the disease. For the physician, there is very little benefit.

With regard to the burdens or risks, for the public there is a potentially large one. First, is the fact that Mevacor would be the first drug to be sold OTC that would not be used for acute or occasional symptoms or illnesses or taken for brief periods as with all the other OTC drugs. The statin drugs will be started as something to protect or improve cardio-vascular disease, an illness that may not have any symptoms at the time. The other difference is that the drug is expected to be taken continuously, life-long. Further, it was simply the symptoms that have motivated the public to purchase and take the previous OTC drugs. In the case of Mevicor, without symptoms, it will require the public to go out and get a blood test of cholesterol levels and then themselves evaluate whether with these values and knowledge of their personal risk factors they should start taking the drug. Of course they could go to their physician for help but then that would eliminate the self-care benefit. In addition, the public would have to understand the potential adverse effects of the drug and also complications with drug interactions and be conscientious enough to continue periodic blood tests over their lifetime to check for toxicity and sufficient lowering of cholesterol or other markers of benefit. Also they would need to be aware when to seek a physician's evaluation regarding abnormal test results including need to switch to a more potent dosage or medication, requiring a prescription. Would the public have the motivation with Mevacor to faithfully carry out all these requirements indefinitely by themselves? Such a task would be unknown to those purchasing current OTC medications.

The burden for the pharmaceutical company is to be sure that the public was sufficiently informed before and after purchasing the statin drug about its indications, dosages, side-effects and cautions. The company must provide everyone proof that the statin drug can be used OTC and safely. In the case of Mevacor, the pharmaceutical company completed one study that suggests this is true. (Here again is the link to a review of the study.)
However, one might argue the possibility of conflict of interest for a pharmaceutical company to make such a study themselves and there might be bias present. Although a statin drug has been made available to the public without a prescription in the U.K. and the change has been said to be satisfactory. However, I understand that the way the public obtains the drug is different in the U.K. than in the U.S. in that they do not themselves take it off the shelf but are handed the drug by the pharmacist who may be doing some screening and educating at the same time. If any complications in the use of the OTC drug by the public develop, the pharmaceutical company will bear a large part of the burden.

With regard to the risks and burdens for the insurance company or the government, treatment of the patient's medical complications because of taking the OTC drug will have to be paid for. For the physician, there may be only a downside for this action. New patients who should have made an office visit seeking physician’s advice might not do so and patients who have been under a physicians care and monitoring may fail to appear or the self-care may complicate overall management. I may be wrong in this assessment.

And what are the benefits and risks of the other stakeholder, the FDA, which I failed to mention at the outset of this post? Remember, it is the FDA that is responsible for the final decision to switch. If everything goes well with the switch to OTC, everybody including the public, Congress and of course the drug companies will congratulate the FDA. If there are serious complications.. well, look at the current concern and finger pointing about FDA with regard to Vioxx and other drugs.

So what is the conclusion? Is this an ethical dilemma? Not really. The decision is clear. I would say that at this time, the potential harms to the public have not been unequivocally proven to be so minimal that the benefits would easily trump them. I would advise additional behavioral testing of public use of OTC Mevacor be performed by groups other than the pharmaceutical companies before the switch is decided. That is my opinion. What is yours? ..Maurice.