A Tucson-based national organization of doctors has sued the federal Department of Health and Human Services for putting roadblocks in the path of physicians who want to prescribe hydroxychloroquine to prevent COVID-19.
The lawsuit, filed in Michigan, asks a federal judge to overturn an order by the Food and Drug Administration, part of HHS, which says the drug can be obtained from the Strategic National Stockpile only when a patient has the virus and is hospitalized. Dr. Jane Orient, executive director of the Association of Physicians and Surgeons, told Capitol Media Services the agency is illegally restricting the rights of doctors to choose what is best for the patients.
The action comes after Gov. Doug Ducey in April imposed his own restrictions on the use of hydroxychloroquine, forbidding Arizona doctors from prescribing the drug for prophylactic purposes absent a peer-reviewed medical study showing it is effective. To date, there has not been one.
She and Dr. Michael Robb, the president of the Arizona chapter of the association, wrote to Ducey later that month asking him to rescind the order.
“We got no response at all,” she said.
The lawsuit comes as another 789 new cases were reported Monday, bringing the Arizona tally to 27,678, including 1,047 deaths. It also comes as the number of patients hospitalized with confirmed or suspected cases of COVID-19 is 1,266, just 12 fewer than the record set two days earlier.But Orient said Monday the decision was made to sue not Ducey but the FDA. She said the presumption is that if its orders are voided, the governor will have no basis to deny the drug to Arizona residents.
Central to the issue is whether individuals who fear the virus should be able to get the drug which has been approved by the FDA to treat autoimmune conditions like lupus and rheumatoid arthritis.
It gained national attention when President Trump not only promoted it but announced last month that his personal physician had written him a prescription to take a full course of it in hopes of preventing the disease.
The lawsuit contends that FDA officials from prior administrations “acted contrary to the wishes of President Donald Trump by arbitrarily limiting the use of HCQ from the strategic national stockpile.”
There’s a political component to all of this
It comes as Trump said he won’t have the Republican Convention in North Carolina because the governor there has said he would allow it to be held only if it can be done safely. That involves either limiting the number of delegates or requiring attendees to take precautions, like wearing masks.
“This arbitrary, irrational and unjustifiable interference by defendants with the use of HCQ as a prophylaxis interferes with the political process by which the United States selects its president: national political conventions,” association attorney Andrew Schlafly wrote in the lawsuit. He said continued interference with allowing doctors to prescribe the drug “has the effect of infringing on the right of the people to hold national political conventions, which has been an essential part of our presidential elections since at least 1832.”
Key is the power of the FDA over prescriptions.
“The FDA has the authority to approve drugs based on safety,” Orient said. “And then they can also approve it for specific indications.”
But she also said that at least 20 percent of the prescriptions written by doctors for all drugs are for “off-label” uses, something the FDA specifically allows. She said that makes sense because once a manufacturer gets FDA approval of a drug as safe for one purpose “it’s a hugely expensive endeavor” to get similar approval for another purpose.
“And once a drug is generic, there is no incentive whatsoever to invest all that money,” Orient said.
More important, she said, the FDA does not require separate safety indications for each and every use of the drug.
“It’s either safe, or it isn’t,” Orient said. And she noted it has been approved for various autoimmune diseases.
“It’s not safe for use for lupus but not safe for COVID-19,” she said.
But as recently as April 24 the FDA put out an advisory against out-of-hospital use of hydroxychloroquine “due to risk of heart rhythm problems.”
Orient said there is no reason to believe the drug is dangerous.
She said the main study, published in the Journal of the American Medical Association, came out of Brazil. Orient said what it found were problems with high doses — doses she claimed were lethal.
“If you give a lethal dose to patients who are desperately sick, then I’m surprised that more of them didn’t die,” she said. “It in no ways proves that hydroxychloroquine is dangerous when used as directed.”
The association is best known for its opposition to mandatory vaccinations. Orient said the two issues are not related medically, though she said there may be a political link.
“People are against having an effective, safe, treatment that has been used for 65 years, hundreds of millions of people, and it can be produced very, very cheaply, that you have an effective treatment and there’s less pressure to vaccinate everybody,” she said.
A spokesman for the FDA said it does not comment on pending litigation.
But the agency did send a link to a column by Dr. Stephen Hahn, the FDA commissioner, justifying the limits on the use of supplies in the Strategic National Stockpile and saying that one reason the drug was added was to help ensure that there would be a supply for those who need it for non-COVID-19 conditions.
There was no immediate response from Ducey either to the lawsuit or why he did not answer the April letter from the doctor group.