Pharmaceutical corporations shouldn't play favorites in offering entry to experimental Covid-19 therapies


Last month, U.S. President Donald Trump and former New Jersey Governor Chris Christie were diagnosed with Covid-19 and have been hospitalized almost every day since the pandemic began, as have tens of thousands of other Americans.

But Trump and Christie were special cases. They received experimental Covid-19 treatments that are not readily available to the public. They have since recovered and publicly acknowledged that US companies gave them access to drugs that are still banned for the vast majority of Americans with the disease.

Her treatment has sparked much conversation about the perception that the rich and famous have priority access to health care. What has received much less attention is whether these two men evaded the rules to gain access to experimental drugs outside of clinical trials, and if so, how their actions might affect drug development.

Critically ill patients with no other options are allowed to receive drugs under development by law before the drugs are approved by the U.S. Food and Drug Administration. The rules for this access are necessarily strict in order to protect not only the parties involved but also the clinical development process itself.

Allowing people to bypass these regulations can delay or fail this process. Even the perception that rules are bent in this way could cast public doubts about participating in clinical trials. This is problematic in any case, especially if the drugs in question are being developed to contain a pandemic.

What is expanded access?

For decades, pharmaceutical companies have provided some patients with access to investigational drugs outside of clinical trials through a route known as expanded access. Historically referred to as "compassionate use," expanded access allows a patient with a serious or life-threatening medical condition to try such products as a final step.

Patients must meet several criteria to qualify for expanded access. No FDA approved therapies should be available to the patient. The request for access must be made by a doctor who has determined that the potential benefits outweigh the potential risks. The patient does not need to be able to register for a clinical trial. and the company must believe that granting access will not adversely affect clinical trials of the product.

These last two requirements are particularly important as the FDA evaluates the safety and efficacy data collected during clinical trials to determine if new treatments should be approved and makes them available to many more patients. It is already difficult to get enough people to take part in clinical trials. When patients can access experimental drugs without signing up for one, it becomes even more difficult to collect this critical data. Disregarding the letter or spirit of the Extended Access Act could seriously damage not only the drug development system, but public confidence in the system and the public's health as a whole.

Trump tested positive for Covid-19 on or about September 30. After he was discharged from the hospital, he repeatedly stated that he received "Regeneron" – that is, he received Regeneron Pharmaceuticals' antibody cocktail called REGN-COV2 through an extended access. He even said it healed him.


Steven Gregory