Hydroxychloroquine no longer authorised by FDA to treat Covid-19

Hydroxychloroquine has received a lot of attention as a possible treatment for Covid-19, particularly due to Donald Trump promoting it and using it.

But the US Food and Drug Administration has revoked approval for its use for Covid.

Financial Times: US regulator ends emergency use of hydroxychloroquine for virus

The US regulator has revoked its emergency approval for hydroxychloroquine, an antimalarial drug that was lauded by US president Donald Trump and has been used to treat Covid-19 patients across the world.

Shortly after the pandemic engulfed the US, Mr Trump hailed hydroxychloroquine as a “game-changer” and played down its risks, saying at a press conference: “What do you have to lose?”

Later, he said he had taken the drug himself, trying it as a potential preventive measure to stop him developing Covid-19 after several White House officials had contracted the infection.

The Food and Drug Administration said new data from trials showed the drug did not improve the condition of patients or have an antiviral effect, so the benefits did not outweigh the risks.

Denise Hinton, chief scientist of the FDA, said that hydroxychloroquine and chloroquine, a similar drug, were no longer authorised to treat Covid-19 patients, as of Monday.

“The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence,” she said in a statement.

In a letter to the director of medical countermeasures at another branch of the health department, she wrote that earlier observations that it decreased the shedding of the virus had not been consistently replicated — and recent data from a randomised clinical trial showed no difference between hydroxychloroquine and the “standard of care”: drugs usually used to treat hospitalised patients, such as those administered in intensive care.

It always seemed a long shot that hydroxychloroquine may be some sort of miracle treatment or cure. It may still be found to have some benefits, but I think that rushing into using unproven drug treatments is fairly silly and risky. Even drugs that work well usually have adverse side effects.

Meanwhile the worldwide number of Covid cases continues to increase, and while the death rate seems to have slowed total official deaths are now at 438,000 and likely to be under-reported.

And in the US relaxing lockdowns is still a contentious issue as case numbers surge in some states. See:

And while Trump Campaign Touts 1 Million Ticket Requests for Tulsa Rally the number of cases is also increasing there – see https://coronavirus.health.ok.gov/

US health official transferred after he “resisted efforts to provide an unproven drug on demand”

NBC: Top health official says he was ousted for pushing back on Trump’s ‘game changer’ drug

“I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the COVID-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit. I am speaking out because to combat this deadly virus, science — not politics or cronyism — has to lead the way,” Dr. Rick Bright said Wednesday in a statement issued by his lawyers.

“Specifically, and contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the Administration as a panacea, but which clearly lack scientific merit. While I am prepared to look at all options and to think ‘outside the box’ for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public,” Bright said in the statement, which was first reported by The New York Times.

Bright was deputy assistant secretary of health and human services for preparedness and response and director of the Biomedical Advanced Research and Development Authority, or BARDA, until earlier this week, when, he says, he was “involuntarily transferred to a more limited and less impactful position at the National Institutes of Health.”

Asked about Bright’s transfer at the White House coronavirus briefing Wednesday night, Trump said, “I never heard of him.”

That’s typical denial from Trump.

NPS: NIH Panel Recommends Against Drug Combination Promoted By Trump For COVID-19

A panel of experts convened by the National Institute of Allergy and Infectious Diseases recommends against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of potential toxicities.

“The combination of hydroxychloroquine and azithromycin was associated with QTc prolongation in patients with COVID-19,” the panel said.

QTc prolongation increases the risk of sudden cardiac death.

On April 5, though, without any more evidence of efficacy, he went further:

“What do you have to lose? And a lot of people are saying that when — and are taking it — if you’re a doctor, a nurse, a first responder, a medical person going into hospitals, they say taking it before the fact is good.  But what do you have to lose?  They say, ‘Take it.’ I’m not looking at it one way or the other, but we want to get out of this.  If it does work, it would be a shame if we didn’t do it early. But we have some very good signs. So that’s hydroxychloroquine and azithromycin.”

As for using the use of hydroxychloroquine or chloroquine alone, the panel said there was “insufficient clinical data to recommend either for or against.” It reached the same conclusion about the drug remdesivir.

“It’s all based on the data,” said panel member Dr. Susan Swindells, a professor in the department of internal medicine at the University of Nebraska College of Medine.

The gut feeling of a president may be right sometimes but it can easily be wrong, and with potentially many lives at risk shooting of recommendations by Twitter are downright dangerous.

Covid-19 daily post: 6 more cases, 1 more death

I’m doing this a bit different, starting early to put things of interest on before the daily update at 1 pm.

Study Of Hydroxychloroquine As Coronavirus Treatment Finds More Deaths, No Benefit

A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported.

The nationwide study was not a rigorous experiment. But with 368 patients, it’s the largest look so far of hydroxychloroquine with or without the antibiotic azithromycin for COVID-19, which has killed more than 171,000 people as of Tuesday.

Researchers analyzed medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11.

About 28% who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival.

Hydroxychloroquine made no difference in the need for a breathing machine, either.

Researchers did not track side effects, but noted a hint that hydroxychloroquine might have damaged other organs. The drug has long been known to have potentially serious side effects, including altering the heartbeat in a way that could lead to sudden death.

Earlier this month, scientists in Brazil stopped part of a study testing chloroquine, an older drug similar to hydroxychloroquine, after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested.

While “The nationwide study was not a rigorous experiment” it adds to the knowledge on hydroxychloroquine. This has been reported by a number of media.

Fox News:  Kentucky sees record spike in coronavirus cases days after lockdown protests

Kentucky witnessed its highest daily spike in coronavirus cases Sunday – just days after hundreds of protesters broke social distancing measures and gathered outside the state capitol building to demand Gov. Andy Beshear reopen the economy.

Despite the demonstrations, Beshear, a Democrat, said Kentucky would not begin incrementally reopening the economy or easing its lockdown restrictions until seeing a downward trajectory of reported coronavirus cases for at least 14 days.

It was not immediately clear whether the surge in cases was linked to the protests.

Police have charged nearly 4000 people with breaching lockdown restrictions, many in the days before the prime minister announced the change next week to alert level 3. As the country entered the final week of alert level 4, there were increased reports of people stepping out of their bubbles, congregating in public areas and not obeying physical distancing rules.

RNZ have bits from the Epidemic response Committee today: https://www.rnz.co.nz/news/national/414800/covid-19-live-updates-from-new-zealand-and-around-the-world-on-22-april

Daily update from Dr Ashley Bloomfield

6 new cases (all confirmed), the total now 1,451

3 new cases linked to travel, 3 linked to known clusters.

Another death from Rosewood Rest Home, a woman in her 80s, total deaths now 14.

1,036 recovered now,

11 in hospital, 2 in ICU (both stable)

A record 5,289 tests were completed yesterday, total tests now 94,497

Health Order amended

The following order requires premises to be closed, with the exception of essential businesses, and prohibits mass gatherings.

On 21 April an amendment was made to this order to allow businesses to carry out necessary work ahead of New Zealand moving to Alert Level 3.

Prime Minister Jacinda Ardern

Safety for schools and workplaces remains paramount as some prepare to re-open.

Ardern disagrees with the Medical Association describing the flu vaccine as a debacle, saying they started the programme sooner than normal (but that doesn’t explain distribution problems).

See ODT Live: Govt criticised over flu vaccine ‘debacle’, Covid funding

The roll-out of the flu vaccine which saw doctors go without for up to 10 days without supply has been described as a “debacle” and “total disaster” by the NZ Medical Association.

And the block of second tranche of funding to GPs could see some practices and doctors without work by next week, the association’s chair Kate Baddock warned the Epidemic Response Committee today.

The NZ Medical Association, Aged Care Association, Pharmacy Guild, Disability Support Network, Dental Association and epidemiologist Professor David Skegg  were making submissions to the committee, which assesses the Government’s response to the coronavirus. The committee is chaired by Opposition leader Simon Bridges.

Dr Kate Baddock said the issues with the roll-out of flu vaccine meant her practice went without for 10 days while they had 4000 vulnerable people they needed to vaccinate.

“The flu vaccine was a complete debacle – there’s absolutely no doubt about that,” she told the committee.

And news that Cabinet had stopped another tranche of funding to keep GPs will have an immediate impact on practices, she said, with some GPs who are going to be out of work by the end of the week.

“We are very much hand to mouth in terms of cash flow … when that cash no longer flows because we have delayed payments because of virtual consultations … that cashflow which funds out staffing requirements is just not there.”

She said the ministry, DHBs and minister all agreed on the funding before lockdown but “have reneged on that expectation”.

There have been 4128 breaches of the CDM and Health Acts under the level four lockdown
– 433 have been prosecutions, 3580 official warnings and 115 youth referrals

As at 9.00 am, 22 April 2020
Total Change in last 24 hours
Number of confirmed cases in New Zealand 1,113 6
Number of probable cases 338 0
Number of confirmed and probable cases 1,451 6
Number of cases currently in hospital 11 -1
Number of recovered cases 1,036 30
Number of deaths 14 1

There will be an announcement tomorrow on what rules will be in place for hunters under the level three lockdown.

Will the election go ahead in September? There’s time to access the right alert level for an election to be held – Ardern hints at Level 2 – but decisions will need to be made by some time in June.

Dr Bloomfield – we have not just got down to a very small number of new cases, but more importantly all the new cases are now coming from known sources.

Ardern is expecting that Minister of Health David Clark and Deputy Prime Minister Winston Peters will return to Parliament in Wellington under Level 3 next week.

Possible benefits but risks promoting unproven coronavirus treatments

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.