Association of American Physicians and Surgeons Sues FDA for “Irrational” Interference of Access to Life-Saving Hydroxychloroquine

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DF of complaint: http://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf

Today, June 2, 2020, the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.

Two million doses of HCQ are being sent by the Trump Administration to Brazil to help medical workers there safeguard themselves against the spread of the virus. But at the same time the FDA continues to block Americans’ access to this medication.

HCQ has been approved as safe by the FDA for 65 years, and the CDC states on its website that “CDC has no limits on the use of hydroxychloroquine for the prevention of malaria.”

More than 150 million doses have been donated to the strategic national stockpile controlled by the federal government, but unjustified FDA restrictions limit its use to only hospitalized patients for whom a clinical study is unavailable. Hospitals are even returning HCQ to the stockpile because they are not able to use it effectively.

“It is shocking that medical workers in Brazil will have access to HCQ as a prophylaxis while Americans are blocked by the FDA from accessing the same medication for the same use,” observes AAPS Executive Director Jane Orient, M.D.

“There is no legal or factual basis for the FDA to limit use of HCQ,” states AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”

Many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19, AAPS points out.

“Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans’ right to access medication donated to the federal government for public use,” Schlafly says. “By preventing Americans’ use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year.”

“FDA Commissioner Stephen Hahn states that the FDA does not interfere with physicians’ ability to prescribe HCQ, and yet at the same time the FDA denies access by millions of Americans to 150 million doses of it in the national stockpile,” Schlafly adds. “This irrational hoarding by government is an abuse of power.”

The Association of American Physicians and Surgeons (AAPS) has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.

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I hope no one had a friend or family member suffer or die because of irrational thinking or behavior .
 
CAC Alert.
This is all you need to know about that association
The Association of American Physicians and Surgeons (AAPS) is a conservative non-profit association founded in 1943. The group was reported to have about 5,000 members in 2014. The association has promoted a range of scientifically discredited hypotheses, including the belief that HIV does not cause AIDS, that being gay reduces life expectancy, that there is a link between abortion and breast cancer, and that there is a causal relationship between vaccines and autism. It is opposed to the Affordable Care Act and other forms of universal health insurance.
 
Context.

US Revokes Emergency Use Of Malaria Drugs For Coronavirus

WASHINGTON (AP) — United states regulators on Monday revoked emergency authorisation for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause serious side effects.
The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus.
Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”
The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.
The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus.
The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.
Dr Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.
“There has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective” for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.
On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies, and “that, I’m sure, had influence on the FDA,” Nissen said.

The actions by FDA and NIH send a clear signal to health professionals against prescribing the drugs for coronavirus.
 
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