The Texas Medical Board has clarified that it never prohibited doctors from using hydroxychloroquine to treat COVID-19 patients, but affirmed its warning not to tout the drug as a “cure.”
Hydroxychloroquine is a drug commonly used to treat malaria, lupus, and rheumatoid arthritis. Doctors have used it in clinical settings to treat COVID-19, but the U.S. Food and Drug Administration has declined to recommend it for treating the disease.
The drug became a kind of political football with many Republicans playing up its effectiveness and Democrats questioning it.
A press statement from the Texas Medical Board on Friday comes after Texas Senator Bob Hall earlier in the week sent a letter to TMB President Sherif Zaafran accusing the regulatory body of making “thinly veiled threats to Texas doctors” who prescribe hydroxychloroquine.
Hall claimed that there were “bureaucratic roadblocks” that prevented doctors from prescribing the drug, adding that there is “a lot of blood on government bureaucrat hands.”
In a press release, the Texas Medical Board responded to “misinformation” regarding its position on COVID-19 treatments.
“The Texas Medical Board has never prohibited the use of Hydroxychloroquine alone, or in conjunction with other drugs, for the treatment of COVID-19. In fact, the TMB does not prohibit any drug or treatment,” said Dr. Zaafran. “The off-label use of Hydroxychloroquine as an alternative therapy for COVID-19 patients is completely permissible.”
However, he noted that physicians must comply with a Texas regulation “to provide full disclosure of treatment options, side effects, and obtain informed consent.”
Zaafran made the same remarks on social media and at a regular quarterly meeting of the Texas Medical Board on Friday. “During the meeting, I unequivocally reiterated there is no prohibition on prescribing Hydroxychloroquine,” he wrote on Twitter, tagging six state senators, several of whom are medical doctors.
In another post with side-by-side images of the TMB statement and Hall’s letter, Zaafran wrote more emphatically, “THE TEXAS MEDICAL BOARD HAS ALREADY MADE THIS ABUNDANTLY CLEAR!”
‘No Definitive Cure’
Political pressure on the Medical Board escalated after a July 31 statement in which the board implicitly threatened action against a Houston doctor who appeared in a video promoting hydroxychloroquine as a “cure.”
“Hello, you don’t need a mask. There is a cure,” said Dr. Stella Immanuel, a Nigerian-trained pediatrician working in Houston.
The video, filmed on the steps the U.S. Supreme Court, was retweeted by President Trump.
Texas’ medical regulator shortly thereafter issued a statement saying, “In the past week there was a widely published claim of a ‘cure’ for COVID-19. As we are all aware the medical community is still learning, researching and gaining understanding of the virus. While there are drugs and therapies being used to treat COVID-19, there is no definitive cure at this time.”
“There cannot be false, misleading or deceptive advertising or statements made regarding any therapies, including a cure for COVID-19.”
The Texas Medical Board has statutory powers to investigate misleading or deceptive claims by doctors, as well as violations of its rules on standards of care.
In its July 31 statement, TMB noted that it “does not issue endorsements of the use of any specific drugs or treatments for COVID-19, but any treatment decision must be made with full, proper and accurate disclosure by a physician.”
Dr. Zaafran followed up on that today, saying, “Licensees should not fear disciplinary action from the TMB simply for expressing their support of specific COVID-19 treatments like Hydroxychloroquine.”
“What providers should keep in mind is because there is no definitive cure, claims of a cure may constitute false, misleading or deceptive advertising, which is prohibited by law and may prompt an inquiry from the TMB.”
FDA Position
The U.S. Food and Drug Administration on March 28 authorized the emergency use of hydroxychloroquine from the Strategic National Stockpile to treat patients hospitalized with COVID-19.
But the FDA later reversed itself, citing “recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery.”
Given that finding, the agency concluded that the risks, which include the possibility of serious heart rhythm problems, outweighed the possible benefits of prescribing the drug.
However, the FDA did not ban the use of the drug, it merely withdrew its formal guidance for using it to treat COVID-19.
FDA Commissioner Stephen Hahn clarified, “Prescribing a product for uses not specifically included in the official labeling is common in the practice of medicine. In oncology and mental health, many patients are treated this way.”
Patients and their doctors “must ultimately decide what treatment is likely to be best for the individual patient,” Hahn stated.