The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients rights. <\/p>\n
The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. <\/p>\n
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The bills chief champion, Sen. Ron Johnson (R-Wis.), declared it a victory for individual liberty over government, and for the right to hope. Its also been championed by the libertarian Goldwater Institute, and Vice President Mike Pence, who tweeted that it gives patients hope & a chance. <\/p>\n
The legislation would allow patients with serious diseases anything from a late-stage cancer to multiple sclerosis to request access to experimental drugs directly from drug companies without having to go through the FDA, which has its own compassionate use program that approves 99 percent of requests. <\/p>\n
But the right-to-try bill doesnt require drugmakers to make the experimental treatments available. In the 37 states that have similar laws on the books, Goldwater can point to only one doctor who says he has utilized a state right-to-try law for a patient and that medicine was being made available to certain patients by the FDA anyway. <\/p>\n
Thats led some critics to call it right-to-ask and it may give desperately ill people false hopes. <\/p>\n
This bill is inherently deceptive, Alison Bateman-House, a medical ethicist at New York University who led the charge against Johnsons bills, wrote in an email. What [patients] have a right to (and did long before this bill) is to ask drug companies for permission to use their experimental drugs outside of clinical trials. If the drug company says no, both before and after this legislation, that's the final word: neither the FDA nor the courts have to power to make companies provide access to their experimental drugs-in-development. <\/p>\n
And if the experimental drugs do become widely used outside the standard clinical trial system, it could undermine some of the rigorous science needed to know whether medicines are safe and effective. Many drugs that start the clinical trial process flop. Some are harmful. <\/p>\n
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You have a situation where patients think they want to take a risk and dont necessarily understand what risk they are taking,\" said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill. <\/p>\n
And while the revised bill would require annual reports on whether the drugs used by these patients helped or potentially harmed them, patient safety experts are concerned it may not be enough. <\/p>\n
But its hard for lawmakers to say no to hope. <\/p>\n
Opposing right-to-try laws is akin to opposing motherhood, apple pie, and the American flag; you just dont do it and expect to be re-elected, David Gorski, an oncologist at Wayne State University, wrote in his blog on science-based medicine. Its easier for a senator to vote for the bill than to explain to constituents the nuances of why the new law might not help them and might even harm them. <\/p>\n
PhRMA issued a statement but declined to say whether it now supported the bill, which must still be approved by the House after the summer recess. We appreciated the opportunity to work with Sen. Johnson and look forward to continuing to work with his office, it said. The revised Right to Try legislation that passed the Senate includes important protections for patient safety and the clinical trial process. <\/p>\n
Senate HELP Chairman Lamar Alexander (R-Tenn.) and ranking Democrat Patty Murray (D-Wash.) the same duo who are about to embark on bipartisan Obamacare stabilization\" hearings played a role in helping Johnson work out a compromise. Alexander told POLITICO after the vote that Johnson tried to run it by everyone who was affected, including the pharmaceutical industry, trial lawyers and patients. Im very happy for him and the patients around the country who will benefit from it. <\/p>\n
Sen. Joe Donnelly (D-Ind.), one of the few Democrats who had been in favor of it all along, said more liberal members all wanted to step up once the revised bill was explained to them. <\/p>\n
FDA also worked behind the scenes to push for changes to make the bill safer for patients. <\/p>\n
Not every senator endorses the libertarian rhetoric about getting federal regulators out of patients' way that propelled right-to-try a key theme of the message the Goldwater Institute took through the states and to Washington. <\/p>\n
Theres no more fundamental freedom than the right to save your own life. Right to Try guarantees that freedom by ensuring that patients, along with their doctors, are in control of the treatments they receive when facing a terminal diagnosis, Goldwater's president and CEO Victor Riches said in a statement after passage. <\/p>\n
But more liberal lawmakers faced significant lobbying, featuring heartbreaking stories of young children or newlyweds facing shortened lives. Meanwhile, the most powerful opposition, the drug industry and doctors groups, kept their disagreement very low-profile. Their soft voices gave lawmakers little political protection for a \"no\" vote. <\/p>\n
Theres no doubt about it there are a lot of patients out there that think this is the answer to their prayers. They certainly believed that, and they pushed their members of Congress to support a bill that in many cases the members of Congress thought was not a good idea, said Zuckerman. <\/p>\n
PhRMAs low-profile on right-to-try hurt detractors from the outset. The industry group never took a formal position on the state right-to-try laws or earlier federal proposals. But it consistently reiterated its concerns about any approach to experimental medicines that sought to bypass the FDA and the clinical trial process. Of the major drug makers, only Merck formally came out against the earlier Johnson bill. <\/p>\n
Its huge, NYUs Bateman-House said of PhRMAs reluctance to take a stronger public stance. When I speak with legislators, they say, Well if its that bad, why isnt pharma speaking against it? <\/p>\n
Critics of right-to-try concede the final Senate bill is much improved from earlier versions. It adds crucial safeguards that should help protect patients' safety and their pocketbooks, as they can no longer be charged excessive amounts for unproven drugs. <\/p>\n
But the critics, including bioethicists, safety advocates and researchers, still worry about the risk of undermining an agency like the FDA an important safety regulator that has ensured that drugs are studied in controlled settings so FDA can make informed decisions to approve or disapprove them. <\/p>\n
The bill looks to be an \"improvement,\" said Patti Zettler, a professor at Georgia State University and former associate chief counsel at FDA. \"However, the fundamental problem with the bill is not resolved in that it still envisions removing, or drastically reducing, FDA's role in expanded access.\" <\/p>\n
And it may fall short an example of Congress checking a box, but not really solving a problem. <\/p>\n
Its something where your reluctant representative can claim they are taking action but does not effectively address root problems, said Ameet Sarpatwari of Harvard Medical School. Weve seen this with rising drug prices, and now we see it with experimental treatment. It is a show, but it is also dangerous in the sense that it furthers this sort of attack on FDA as somehow being antithetical to the interest of patients. <\/p>\n
Correction: A previous version of this story misidentified Patti Zettler's affiliation. She is a professor at Georgia State University. <\/p>\n
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Libertarians score big victory in 'right-to-try' drug bill - Politico<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients rights. The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care Continue reading