Healthy science is still essential in the rush to innovate COVID-19 pharmaceuticals

Hydroxychloroquine and chloroquine It has been at the center of debate during the last few weeks when drugs should be used to treat COVID-19. Neither product has strong evidence to support its use for this purpose. Small studies reported to date have had serious flaws or have failed to demonstrate efficacy.

Nevertheless, the president cannot stop Press themClaims that the patient has nothing to lose. Doctors, bioethicists, drag As lawyers, we have a responsibility to turn our attention here. So Civil servant Scientists are in a hurry to innovate, but do not overlook the important role of strong regulatory protection in supporting the ability to actually understand which drugs work against COVID-19. To weaken our commitment to science and evidence during this crisis is reallyWorse treatment“Than sick.

FDA Emergency Use Permit

There are no drugs approved by the Food and Drug Administration to treat COVID-19, and no products have strong data supporting their use for this disease. Nevertheless, the FDA said on March 28, Emergency use permission (EUA) Certain hydroxychloroquine sulfate and chloroquine phosphate products have been donated to strategic national stockpiling by various pharmaceutical companies. The EUA has been granted exclusive access to the Biomedical Advanced Research and Development Authority (BARDA) and has been providing these stockpile drugs to local public health authorities for unapproved use in the treatment of hospitalized COVID-19 patients who are unable to participate in clinical trials. Authorized for distribution to authorities.

Ah EUA It is not the same as FDA’s traditional marketing approval. To be approved under normal rules, a drug must show that it is safe and effective for its intended use. In contrast, the EUA is granted in the face of a public health emergency based solely on the decision that a product may be effective and its potential benefits outweigh the potential risks. Temporary approval. This EUA was only supported by “ limited in vitro and case clinical data in a series of cases ”-approval of the opposite data or Serious safety concerns. Overall, there is even more confusion about the promises and uncertainties of these drugs.

Off label use

EUA Not the only way COVID-19 patients may have access to hydroxychloroquine and chloroquine. Physicians are generally free to prescribe approved drugs for unapproved uses as part of their authority to perform medical practices. This is called “off-label use.” Some hydroxychloroquine and chloroquine products are FDA approved for malaria, lupus, and rheumatoid arthritis and are therefore eligible for off-label use of COVID-19.

Following President Trump’s comment that these drugs have potential,Game changerHowever, despite warnings from experts, attention and prescriptions have surged. Stockpile drugs for personal use, And some hospitals use hydroxychloroquine as the standard treatment for COVID-19. Efforts have been made to protect supplies to patients in need of drugs for proven indications, but some of these patients have Go without.

is Too early to say Whether chloroquine products work with COVID-19 Some clinical studies A small, poorly randomized or carefully matched control group. Causes serious side effects Some hospitals Stop their use altogether.

There is a great need for rigorously conducted clinical trials on these products and their possible effectiveness in combating COVID-19. However, if a physician continues to take off-label prescriptions without considering proper testing, anecdotes, not evidence, will be left.

Expand access to new drugs

There are other drugs that may fight COVID-19, but there are no off-label prescriptions as their use has not yet been approved. These drugs are currently being investigated in clinical trials in the United States and around the world. For seriously ill patients, the FDA Route Known as “extended access” (sometimes referred to as “caring use”) where an unapproved drug can be administered and used to treat patients if they cannot enroll in a clinical trial. This eligibility limitation ensures that patients cannot gain access by opt-out of trials designed to create the necessary evidence to confidently evaluate the safety and efficacy of the product It is important to

Pharmaceutical company Gilead has emphasized this approach with the antiviral drug Lemdecivir in clinical trials. Even if it opens Extended access program Through a wider path, the company explained Its participation Clinical trial Become the primary mode of patient access.

Focus on science

Because patients are in great need of treatment, collecting data in real time requires pragmatism. That is exactly the approach adopted by the World Health Organization Mega trial One of four potential treatments for COVID-19, including remdecivir and chloroquine products, with participation in more than 70 countries. The trial, appropriately named SOLIDARITY, is designed to minimize the burden on physicians and patients while allowing the random assignment and collection of systematic anonymous data.

We simply have to stop speculating what works for patients fighting COVID-19. Today and tomorrow, scientists and policymakers, businesses and doctors Severe research. Off label use and extended access may be a reasonable option for patients in the absence of available clinical trials, but registration should be prioritized where possible.

FDA shows willingness to increase speed trial Facilitates data collection. However, its regulatory standards must not be short-circuited, and its flexibility must be used with caution. Federal policy in this area should be driven by scientific expertise, not false hope, intuition or short-sighted political demands.

This article was republished from conversation Under Creative Commons license. Read Original work.