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posted by Fnord666 on Tuesday January 09 2018, @11:31PM   Printer-friendly
from the give-it-a-try dept.

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


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  • (Score: 3, Insightful) by mmcmonster on Wednesday January 10 2018, @12:32AM (5 children)

    by mmcmonster (401) on Wednesday January 10 2018, @12:32AM (#620279)

    They own the drug companies.

    The companies will charge $10k/dose or (much) higher, as there is a small lot size.

    Billionaire drug company owners get richer.

    Health care premiums go up for everyone to cover $1M extra in drugs to keep a single patient alive an extra week (or statistically not any longer than without the medication).

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  • (Score: 4, Insightful) by takyon on Wednesday January 10 2018, @12:46AM (4 children)

    by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday January 10 2018, @12:46AM (#620285) Journal

    The FDA man says they already approve 99% of the expanded access requests.

    I'm not sure the patients are always paying for the experimental drugs. They might be getting them free of charge so that the companies can gather data. But even if they are paying, how does the bill change anything?

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    • (Score: 2) by Pino P on Wednesday January 10 2018, @03:21PM (1 child)

      by Pino P (4721) on Wednesday January 10 2018, @03:21PM (#620483) Journal

      The FDA man says they already approve 99% of the expanded access requests.

      How often has cannabidiol (CBD) oil for seizure disorders fallen in the 99%? Or is it in the 1% because of the stigma and DEA red tape around other extracts from cannabis that do get you high, unlike CBD?

      • (Score: 2) by t-3 on Wednesday January 10 2018, @07:28PM

        by t-3 (4907) on Wednesday January 10 2018, @07:28PM (#620585)

        CBDs do get you high, they're just subtler than THC. I've had some more THC strains that were very enjoyable.

    • (Score: 2) by Immerman on Wednesday January 10 2018, @04:03PM

      by Immerman (3985) on Wednesday January 10 2018, @04:03PM (#620498)

      What's the delay in approval? Government bureaucracy + terminal patients desperate enough to try experimental treatments could equal an awful lot of people dying before treatment begins - or just having their ailment advance to the point where they no longer make such good guinea pigs.

      I think most experimental treatments are paid for by the patient (which is appalling - you shouldn't have to pay for the privilege of playing guinea pig for some billion-dollar medical company). And of course insurance doesn't cover experimental treatments.

      There is of course also the distinct possibility that the real gains have nothing to do with the stated purpose of the bill - e.g. section 231, subsection R requires insurers to pay for experimental treatments, which could greatly increase the number of people getting them. Or alternately, some buried loophole could allow the sale of "experimental" snake oil. One would hope the bad press would discourage such behavior, but estimates are that as many as half of all FDA approved drugs are already not substantially more effective than a placebo when independently tested, so snake-oil sales are clearly thriving even within the existing regulatory structure - and if you know you're selling snake oil, why pay for all that fraudulent testing?

    • (Score: 0) by Anonymous Coward on Saturday January 13 2018, @03:14PM

      by Anonymous Coward on Saturday January 13 2018, @03:14PM (#621817)

      I haven't read the bill, but what concerns me is that they will try and use it to get desperate people to pay to be part of drug trials, or even just pay for unproven treatments which probably don't work. Patients taking part in trials really shouldn't be paying because it biases the trials towards those who can pay, this can affect outcomes as rich people tend to be healthier, and if patients are actually part of a trial, they may be in the placebo group, and not getting the drug anyway.