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GOP-led House OKs bill allowing experimental treatments for COVID-19

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Lansing — The GOP-majority Michigan House on Wednesday voted 56-48 to amend state law so that health care providers prescribing experimental or off-label treatments for COVID-19 are shielded from liability.

The bill would amend Michigan’s 2014 Right to Try Act, which allows doctors to prescribe terminal patients experimental drugs that have at least gone through Phase 1 of a clinical trial approved by the U.S. Food and Drug Administration.

The change proposed in the House bill would specify that, in the case of a COVID-19 pandemic emergency, doctors could prescribe experimental or off-label drugs for individuals with COVID-19 — including drugs such as ivermectin or hydroxychloroquine.

The controversial legislation passed largely along party lines Wednesday, with one Democratic lawmaker who publicly disclosed taking hydroxychloroquine for COVID-19 joining the GOP majority. The bill moves next to the Senate.

Republicans speaking in support of the bill noted Gov. Gretchen Whitmer, while Senate Minority Leader in 2014, voted in favor of the Right to Try Act.

“Shouldn’t the doctor…have the ability to make a decision for his or her patient?” said Rep. Mary Whiteford, the Casco Township Republican who sponsored the legislation. “Isn’t it important that the doctor determine if his or her patient is worsening every single day and may die without treatments? Isn’t a doctor specifically trained to make those important decisions?”

Democratic lawmakers opposed to the bill indicated Wednesday that it would create an unregulated environment where “unscrupulous physicians” could circumvent safety precautions, reporting requirements and oversight to prescribe off-label treatments.

The legislation, said Rep. Bill Sowerby, D-Clinton Township, skirts strict FDA standards that preserve both the integrity of the drug trial and the civil rights of the patient.

“These are all guardrails that exist for a reason,” Sowerby said. “They exist to protect the safety and rights of the patient and ensure that the data collected, whether promising or unfavorable, is complete, untainted and scientifically sound.”

Michigan’s current Right to Try Act allows for the use of an investigational drug, device or biological product to be used on a terminal patient if it’s completed phase 1 of a clinical trial. The act shields the doctor, health care provider or manufacturer from liability, licensing sanctions and Medicare certification losses related to the use of the drug.

The act requires written informed consent from a patient that includes an explanation of the treatment, a description of best and worst outcomes, and a release from liability or payment for the patient’s health plan and provider.

The current law doesn’t list any specific diseases so COVID-19 patients arguably are already covered under the current language. Additionally, doctors already have the ability to prescribe drugs off-label, or for purposes other than the drug’s main treatment focus.

But legislation approved by the House Wednesday appears to underline those permissions and create a somewhat redundant window within the Right to Try Act for off-label drug use.

Rep. Laurie Pohutsky, D-Livonia, said the bill would have the practical effect of encouraging patients to pressure or harass physicians unwilling to prescribe a medication the physicians may feel “is inadequate, inappropriate or is simply unavailable.”

“Intentionally or not, this legislation plays into conspiracy theories and misinformation propagated by foreign governments, snake oil salesmen and random men with podcasts, none of whom are better situated to determine a patient’s treatment than a medical professional,” Pohutsky said.

Rep. Julie Alexander, R-Hanover, argued the legislation merely “clarifies” existing law to ensure access to experimental COVID-19 treatments is allowed. In arguing for the bill’s importance, she pointed to a directive from the Michigan Department of Licensing and Regulatory Affairs in March 2020 warning prescribers and dispensers against stockpiling or prescribing hydroxychloroquine “without further proof of efficacy for treating COVID-19.”

Days later, Whitmer’s administration walked back the notice and requested hydroxychloroquine supplies from the Strategic National Stockpile for use on some patients as federal guidance on the drug shifted and some Michigan hospitals were trying it as an off-label treatment amid rising COVID-19 hospitalizations in Metro Detroit.

President Donald Trump listens as Karen Whitsett shares her story of recovery from COVID-19, in the Cabinet Room of the White House, Tuesday, April 14, 2020, in Washington.

The Centers for Disease Control and Prevention later said data suggested the potential benefits of the anti-malarial drug did not outweigh the risks and the National Institutes for Health said data analysis showed the drug provided no benefit to hospitalized COVID-19 patients. Dr. Anthony Fauci, the nation’s leading infectious disease expert advising the White House, in July 2020 discounted a Henry Ford Health System trial as “flawed” that argued for hydroxychloroquine’s use against COVID-19.

Similarly, the FDA, NIH and CDC have cautioned against the use of the parasite drug ivermectin for treatment of COVID-19 and said there’s insufficient data to recommend it as a treatment.

“Adverse effects associated with ivermectin misuse and overdose are increasing, as shown by a rise in calls to poison control centers reporting overdoses and more people experiencing adverse effects,” the CDC wrote in August. 

Approving the language within the proposed legislation would make sure patients have “any and all options available to them,” Alexander said.

“Protecting Michigan patients’ right to try will give them a stronger possibility for recovery from COVID-19 and a ray of hope to them and their loved ones,” she said.

Rep. Karen Whitsett, D-Detroit, was the lone Democrat to support Wednesday’s legislation. Whitsett was censured by the 13th Congressional District Democratic Party in April 2020 for thanking then-President Donald Trump for advocating for hydroxychloroquine, which she believed helped her recover from COVID-19 at the beginning of the pandemic.

source:GOP-led House OKs bill allowing experimental treatments for COVID-19

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