With the latest revelations about his soured relationship with Attorney General Jeff Sessions dominating cable news and accounts of migrant children ripped from their mothers’ arms under “zero-tolerance” immigration policies trickling in from the southern US border, President Donald Trump was eager to sign so-called Right to Try legislation on Wednesday and declare a victory for the White House.
The legislation, championed by free-market groups and ushered through Congress by Republicans with a spattering of Democratic support, gives patients with terminal illnesses the Right to Try experimental medications that have passed initial safety trials but have not been rigorously tested and approved by the Food and Drug Administration (FDA). Right to Try has plenty of critics in the medical field, but Trump has always been more of a pitchman than a policy wonk during his short time in politics.
At the White House signing ceremony, Trump praised Republican lawmakers and administration officials for bringing the bill to his desk. He even complemented FDA Commissioner Scott Gottlieb, who was initially skeptical of the legislation, on his socks. (“Ooh, I like those — I like those socks, Scott,” reads the official White House transcript.) The president thanked his colleagues for their “extraordinary courage, determination and love,” adding that thousands, no, hundreds of thousands of lives would be saved after signing the bill into law.
“These are experimental treatments and products that have shown great promise, and we weren’t able to use them before. Now we can use them,” Trump said. “And oftentimes they’re going to be very successful. It’s an incredible thing.”
For Trump, signing the legislation appeared to be a no-brainer: just cut the regulatory red tape and let the people access new cures. White House Press Secretary Sarah Huckabee Sanders later lamented that cable news outlets were more interested in Trump’s response to Rosanne Barr’s racist tweets than a new law that is “literally life-changing for millions of Americans.” It’s just another example of how the media is unfairly biased against Trump, she said.
Meanwhile, doctors and medical researchers were casting doubt on Trump’s claims. At best, the Right to Try law will help a few patients suffering from certain terminal illnesses for which there are promising treatments under review, but only if they are wealthy enough to pay for the treatments and the cost of treating any negative side effects, most likely without help from their insurance plan. For this reason alone, the new law is not expected to help nearly as many people as Trump claims.
At worst, critics say Right to Try is a stealth attempt by libertarian ideologues to undermine patients’ rights and chip away at the FDA’s regulatory authority over chemicals that have yet to be proven safe and effective. Medical experts point out that the FDA already has a program for allowing patients to try drugs that have not completed clinical trials, and the agency approves 99 percent of applications. The Right to Try legislation simply cuts government watchdogs charged with protecting consumer safety out of the process.
Of course, the experimental chemicals and devices patients now have the “right” to try must also be effective at treating serious illness without presenting intolerable side effects. According to Vinay Prasad, a doctor and professor of medicine at Oregon State University, this is a feat achieved by only 10 percent of drugs that initially enter clinical trials. Manufacturers must also agree to provide them in the first place.
In a series of tweets, Prasad said Right to Try advocates associated with conservative groups like Americans for Prosperity and the Goldwater Institute had created a “misleading narrative” about a large number of patients who had exhausted their options and wanted to try new drugs. (Right to Try advocates routinely campaigned with sick children to pass laws in a number of states, and a young boy battling muscular dystrophy joined Trump as he signed the bill into law.)
“It isn’t accurate to call these drugs, though, because they are just chemicals, most of which don’t work,” Prasad said.
Vinay Prasad@VinayPrasadMD30 MayReplying to @VinayPrasadMDThis group & partners created a misleading narrative where many sick patients had exhausted proven options and wanted to try "drugs" that were still in clinical trials.
It isn't accurate to call these drugs, though, because they are just chemicals, most of which don't work.
Vinay Prasad@VinayPrasadMDIn fact, multiple studies show that most of these chemicals do not come to market FOR ANY PURPOSE.
7:51 PM - May 30, 2018
~10% come to market FOR SOME USE, but maybe not the use you wanted to "try" it for (i.e. true % chance of benefit, even lower) pic.twitter.com/tSb5rrMJAC
Companies can still deny requests to “try” their experimental treatments and have plenty of reasons to do so, including fear that a bad outcome could lead to lawsuits and delay or threaten a drug’s ultimate approval. In fact, Prasad and other experts say manufacturers, not the FDA, are the real barrier between terminally ill patients and emerging treatments.
The legislation does protect health providers and pharmaceutical companies from legal liability if their experimental products do more harm than good, but manufacturers may not feel protected until that language is tested in court. Despite the “Right to Try” moniker, the law offers no new rights to patients besides the ability to seek treatments that have not been tested and approved by the FDA.
Vinay Prasad@VinayPrasadMD30 MayReplying to @VinayPrasadMDAlso worth noting that the FDA is not holding back cures in cancer or other serious ailments
In fact, they are rubber-stamping the most toxic, and marginal products
The avg cancer drug approved adds 2 months of life!
in ideal settings
less in real worldhttp://www.nfrank.info/site/ckfinder/userfiles/pdf/Unitended%20Consequences%20of%20Expensive%20Cancer%20Therapeutics.pdf … pic.twitter.com/1Vk1eWK4oG
Vinay Prasad@VinayPrasadMDFor these reasons, medical experts argue that the Right to Try law will do little for most families facing a terminal illness, all while curtailing the FDA’s ability to control access to investigational drugs. That’s why more than 300 doctors and academics signed a letter in February urging members of Congress to ditch the legislation, despite pressure from Trump and Vice President Mike Pence.I find it interesting to note what the Right to Try bill does not include
8:11 PM - May 30, 2018
No "Right to Have Approved Drugs Be Affordable"
No "Right to Have Pharma make Better Drugs"
No "Right not to go bankrupt from paying for drugs you need"
No "Right to make companies GIVE the drug"
“This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products,” the authors wrote, adding that their view is shared by the American Lung Association, the Children’s Brain Tumor Foundation, the National Health Council and many other groups.
When it comes to policy, Trump has never been concerned with the fine print. That’s a job he leaves up to staffers and members of his cabinet, many of whom come directly from the world of big business or the far right of the Republican Party. The president promotes their policies with broad strokes and bold promises, just as he did on Wednesday as he signed the Right to Try bill and declared a victory during another week of damaging headlines. In politics, however, the devil is in the details, and what Trump wants you to see on TV is not always what you get.
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News Today: Trump Peddles False Hope to the Terminally Ill With 'Right to Try' Law
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