Overshadowed to some extent by the full launching of COVID vaccine distribution, new technology was made public in January that could have significant implications for the practice of medicine and the potential for making future public health crisis more manageable with less disruption.
Researchers at Ohio State University on January 4 published the results of computer models that can quickly and safely find new uses for old drugs. The method, described in Nature Machine Intelligence, involves the use of massive datasets to predict how human genes interact with medicines. The analysis can then identify compounds that have the promise of being safe and effective treatments for an illness or disease, like COVID-19.
This use of artificial intelligence to determine “drug repurposing” has the potential to save pharmaceutical and clinical researchers time and money in the search for therapeutic drugs. The goal is to find effective drugs that can be used early in infected individuals, and as a preventative to keep people out of hospitals. The model has already been used to find existing drugs that could be repurposed for COVID-19.
Off-Label Prescribing in Jeopardy
During the pandemic, the issue of drug repurposing, otherwise known as “off-label prescribing,” came under intense scrutiny, most notably the drugs, hydroxychloroquine (HCQ) and ivermectin. Physicians on the front lines have been using such drugs to treat infection at its earliest stages, to stop the virus from replicating and making an individual sicker.
In spite of a long-standing history of drug repurposing by physicians and their patients, suppression of this practice during the pandemic became widespread and explicit. It has been a troubling development, says Renee S. Kohanski, M.D, a practicing psychiatrist who recently hosted a webinar for the Association of American Physicians and Surgeons about off-label prescribing and the related issue of informed consent.
Interfering with off-label prescribing threatens the “sacred relationship between doctor and patient,” said Kohanski. “Increasingly and quite sadly, outside agencies are infringing to erode, morph and dilute this profound relationship.”
The Case of COVID-19
HCQ, a drug that has been used safely to treat malaria and lupus for decades, came under attack by the U.D. Food and Drug Administration (FDA) soon after then-President Trump at a press conference heralded the drug as a treatment for COVID-19.
The agency revoked an emergency use authorization of the drug for the treatment of COVID-19, claiming HCQ caused serious, adverse cardiac events when administered during the late stages of infection. The decision intimidated medical practices from using the drug during the early stages of infection when there was little evidence of adverse impact.
Many state governments and medical boards issued directives to medical practitioners that off-label treatments for COVID-19 would not be authorized and those who ignored the directives would be subject to disciplinary action. AAPS, which advocates for the independent practice of medicine by licenses physicians and surgeons, has been tracking these policies and found only four states (FL, NE, ND, and WI) never imposed such negative guidance, and thirteen states (AK, AZ, GA, ID, KY, MI, MS, NV, OH, OK, OR, SD, TX) have reversed restrictions. In many cases, the stated justification for the directive was preserving the supply for established use.
When state medical boards threaten disciplinary action or invite complaints, even anonymously, against practitioners who use available information, their own best judgment, and informed consent of their patients to provide treatment, it has the effect of preventing drug repurposing entirely. “We should not need judges and governors telling us how to practice medicine or telling a pharmacist what they can or cannot fill,” said Kohanski at her webinar.
The “Chill” in One State
In one example, three local medical boards in the state of Colorado State medical boards issued “guidance” on March 28, 2020, stating that the use of HCQ to treat COVID-19 patients was not “the standard of care” and that the boards “have the authority to discipline corresponding licensees who fail to meet their corresponding generally accepted standards of practice.”
House Bill 21-1202 was introduced in the Colorado General Assembly by Representative Stephanie Luck in March, which would allow medical practitioners and prescribers to use HCQ and ivermectin for prophylaxis, outpatient, and in-patient treatment for COVID-19, and would prevent disciplinary action against them for doing so.
The bill failed in committee on a strict party-line vote, with all Democrat members voting against it. The attorney who drafted the bill for Representative Luck, Mark Braunlich, explained the reason for bringing the bill: “Physicians are fearful of losing their license and getting complaints – even anonymous complaints – against them.” Not all off-label use of these drugs amounts to ‘therapeutic nihilism,’ a term used by off-label prescribing opponents, said Braunlich.
Especially for a drug with successful document use, “Why is there suppression of early treatment?” asked Braunlich.
Let Doctors Be Doctors
Kohanski told Health Care News it is important to preserve the sanctity of the doctor-patient relationship, and the ability of that relationship to function without government intervention.
Informed consent is “the key to ALL prescribing and treatment,” said Kohanski. It “presents the patient with the necessary information about the prescribed treatment, to autonomously, in conjunction with their physician (or health care provider) make decisions about what’s right for their body. The government doesn’t get to decide what happens to a patient’s body or make their medical decision.” A public health crisis is an especially important time for providers to have the chance to “consider all options.”
“There has never been a more profound time for a patient and their physician (or health care provider) in the privacy and sanctity of the confidential relationship, to choose what is the right choice for an individual patient,” said Kohanski.
Free to Choose Medicine, an initiative supported by The Heartland Institute, which co-publishes Health Care News, speaks to off-label prescribing. “Consumer choice would break FDA’s monopoly on access to new drugs,” said Bartley J. Madden, author of Free to Choose Medicine. “We need to be free to make our own informed decisions about whether to use not-yet-FDA-approved therapeutic drugs [that] may offer us the opportunity to improve our health or even save our life.”
MicheleMueller(firstname.lastname@example.org) writes from Las Vegas, Nevada.
Ruoqi Liu, Lai Wei, Ping Zhang. “A Deep Learning Framework for Drug Repurposing via Emulating Clinical Trials on Real-World Patient Data,” Nature Machine Intelligence, January 4, 2021: https://www.nature.com/articles/s42256-020-00276-w
Colorado House Bill 21-1202, March 4, 2021: https://leg.colorado.gov/sites/default/files/documents/2021A/bills/2021a_1202_01.pdf