Normally drugs are trialed and tests are peer reviewed before allowing use by the public. There’s a good reason for this. While drugs can be relieving and life saving, they can also cause major problems with unexpected side effects, and some drugs can make some illnesses worse.
We are not in normal times as the Covid-19 virus sweeps around the world and, so far, 68,000 people have died and many more have sustained lung damage and other adverse effects.
The speed with which the virus has spread around the world – it has been out of China not much more than three months – has had scientists and laboratories racing to develop treatments and vaccines (vaccines usually take 1-2 years to develop and test before going public).
People will inevitably self-medicate, either as a hoped for prevention, treatment or cure. But what if a very prominent person promotes an unproven drug? Do the circumstances justify ignoring well established test and certification procedures? What about for future outbreaks? Just try anything that sounds like it may help?
Tricky territory.
Donald Trump publivly promoted a drug that may or may not help treat Covid-19, and may or may not make Covid worse.
Reuters exclusive: Pressed by Trump, U.S. pushed unproven coronavirus treatment guidance
In mid-March, President Donald Trump personally pressed federal health officials to make malaria drugs available to treat the novel coronavirus, though they had been untested for COVID-19, two sources told Reuters.
Shortly afterward, the federal government published highly unusual guidance informing doctors they had the option to prescribe the drugs, with key dosing information based on unattributed anecdotes rather than peer-reviewed science.
While Trump, in a series of tweets and press comments, had made his opinions on the drugs, chloroquine and hydroxychloroquine, well known, the nature of his behind-the-scenes intervention has not been previously reported. The guidance, published by the Centers for Disease Control and Prevention, has received scant notice outside medical circles.
The episode reveals how the president’s efforts could change the nature of drug oversight, a field long governed by strict rules of science and testing. Rarely, if ever, has a U.S. president lobbied regulators and health officials to focus their efforts on specific unproven drugs.
“The president is short-circuiting the process with his gut feelings,” said Jeffrey Flier, a former dean of Harvard Medical School. “We are in an emergency and we need to rely on our government to ensure that all these potential therapies are tested in the most effective and objective way.”
I normally avoid taking any drugs – or supplements or artificial vitamins – as much as possible. When I had bad toothache (an abscess) recently I had to search the house for painkillers and took some that were past their use by date by a couple of years. When my dentist prescribed antibiotics I took the full course, but I can go for a year or two without using any pills.
If I caught some new virus or disease and there were no proven treatments, I don’t know what I would do if drugs used for other things may or may not help. I would be reluctant, because I think it would be quite a risk. Self treatment based on tweets or other online advice should be viewed with a lot of suspicion. But what if a president promotes it?
In a statement to Reuters, the White House said the president had not launched a “pressure campaign” but was taking appropriate action.
“The President’s top priority is the health and safety of the American people which is why he has brought together the federal government and private sector, including doctors, scientists, and medical researchers, for an unprecedented collaboration to expedite vaccine development,” said the statement, which did not address Reuters questions about the CDC guidance.
In the past a top priority in ensuring health and safety has been extensive testing, both for effectiveness and for side effects and adverse effects.
Online anecdotes are something I would be very cautious about using to inform my treatment.
Administration supporters say the CDC document, highlighting options, makes sense at a time of medical calamity with no proven treatment. And, they note, chloroquine and hydroxychloroquine have been prescribed for years with known risks. Any potential risk to coronavirus patients, some argue, is worth taking given the health crisis.
“In a perfect situation you would never do this,” said a public health specialist who recently left government. “But if you know what the safety downside is, and the patient is ready to try it, it’s worth a try.”
Maybe, but is it really worth the risk if you have no idea if it will work?
Apart from the possibility of adverse side effects or it being detrimental to treatment of the condition it is being used to try to treat, or the risk of addiction (there’s a good reason morphine isn’t promoted for all sorts of conditions) there’s another potential problem.
Some people may choose to self-treat with the unproven drug and think that’s all they need to do. If the drug is ineffective that may delay getting treatment that will help.
And if it’s a contagious diseases like a virus, they could spread it around while they think they are treating themselves.
In a series of conversations last month, President Trump personally instructed top officials at the Centers for Disease Control, the Food and Drug Administration and the National Institutes of Health to focus on the two drugs as potential therapies, said two sources familiar with the president’s efforts.
In seeking a medical breakthrough to the global crisis, Trump had contacted Dr. Stephen Hahn, the FDA administrator, and other top health officials, questioning whether they were moving rapidly enough to make the drugs more widely available, one source said. “He was not happy because of the bureaucracy.”
There’s another potential problem. If what Trump was pushing for does turn out to be a useful treatment, what then? What if Trump decides then to reduce the bureaucracy generally for drug testing? What if Trump promotes other drugs for other illnesses?
What if he starts to tweet about quack remedies, cancer cures, dementia preventers, skin tone improvers?
There are lot of risks with Covid-19. There are a lot more risks in making drug recommendations and availability for Covid and for other conditions unrestricted open slather. Drug companies have been found in the past to cheat normal tests to make money by getting their drugs to market.
Desperate ill and dying people can do desperate things, and can be more gullible to Internet promoted remedies.
There are a lot of risks.
Trump did not raise his voice or express anger, but did emphasize the “urgency” of fast-tracking access to the drugs, the other source said. A cascade of federal action soon followed to make the drugs more available, including the federal government’s grant of emergency authorization to supply them nationwide.
Drug authorisation by President is a dodgy development, especially drug promotion by Trump, who has a history of putting business before health of the environment (and people).
An FDA spokesperson declined to discuss any push by the president or address the CDC-issued guidance. The agency, in a statement to Reuters, said it acted appropriately when, later in March, it issued an emergency order allowing the drugs to be prescribed and distributed.
“It was determined, based on the scientific evidence available, that it is reasonable to believe that the specific drugs may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus outweigh the known and potential risks,” the FDA statement said.
So will the FDA use this as a precedent and fast track more drugs and treatments? “It is reasonable to believe that the specific drugs may be effective” is a major shift from normal approval practices.
In this case what they ‘believed’ may prove to be correct and the drug may turn out to be a successful treatment.
But if bypassing normal checks and balances becomes common practice, it’s probably just a matter of time we get another thalidomide, or some adverse effect that could be worse than the benefits.
Especially if drug companies learn how to speed up their profits at the cost of safety checks.
