Right to Try or Right to Die? Hijacking the FDA For Fun and Profit


… false hope legislation [Right to Try Laws] … put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.” (Public Citizen)

 

 

Sadly, It’s time for our umpty-umpth article on that serial offender —the health care industry – a misnomer as we have seen in previous articles U.S. Healthcare: Getting Less for More  and U.S. Health Care Debacle: You’ll Never Guess Who Benefits?  as its focus is neither health (as in good health) nor care (as in good care). No sooner do we turn to other pressing matters than a new fiddle against the American patient population’s health and wallet emerges. This time it’s legislation which has already passed muster in 37 state legislatures and one month ago in the U.S. Senate (unanimously).

 

We’ve heard all the platitudes about the Right to Try (RTT) law. Like It’s better to try and fail than fail to try. Or “It’s Ok to not know but it’s not okay to not try.” Supporters thunder from their anti-government pulpits that RTT gives terminally ill patients the right to try unproven, experimental therapies that are not yet on the market. In the words of its chief political shill Senator Ron Johnson, whose political ideology lands him at the right-most edge of the wing nut party — “[this bill stands] up for terminally ill patients who want to reclaim their freedom – who want the right to hope.” That bit of flummery comes straight from the mouth of senator one percent, a tax-cutting, social safety net shredding, deregulating, free-market fundamentalist. His brothers (and sister) in arms like anti-government libertarians also support RTT. For their ideologically-driven base it’s a way to defang a federal agency, the FDA, whom they assert is “killing people” by denying them life-saving drugs and devices.

 

Is RTT the game changer its supporters make it out to be or is it another way for the 1% to profit from the desperate search for answers by terminally ill patients? According to Alison Bateman-House, medical ethicist, the benefits of RTT are not shared by all, showering most of its goodies on the 1%. No surprise there. “The public has no idea that this is not a good thing. They know nothing about the bill except that the right-to-try sounds like a good thing.” Which it isn’t as some patients in the 37 states that have passed the legislation quickly found out as they realized their insurance providers would no longer cover them for hospice and home health care if they used their RTT “privilege”. Doubling down on failure, the law in three states, Colorado,
Connecticut, and West Virginia, would penalize patients who use RTT by denying them coverage if unexpected side effects cropped up and, in some cases, would pull their insurance coverage for six months after the end of RTT treatment. Those aren’t the only problems facing patients who find themselves victims of the law. Ask Dr. Michael Carome, director of Public Citizen’s Health Research Group, RTT (Right to Try) will “immunize just about everyone who may be involved…from lawsuits. It reflects a wider push to limit liability for consumers and patients who are injured.” The response of RTT’s cheerleaders, like that of one of its biggest funders, the Goldwater Institute, is 180° to the right of these opinions “there’s no more fundamental right than the right to save your own life. RTT guarantees that freedom by ensuring that patients are in control of the treatment they receive when facing terminal diagnosis.”  Understandable, if patients also have the right to receive enough information about the treatment to enable them to give “informed consent.” RTT laws are silent on that requirement.

 

What makes RTT so dodgy is that it appears to be a solution without a problem. For terminally ill patients searching for an experimental treatment as their last hope, the Food and Drug Administration (FDA) already has an expanded access program that aims to bring patients who have exhausted all publicly available treatments and are ineligible for clinical trials potentially life-saving safe treatments. Reacting to criticisms that response to requests for use of these treatments used to take far too long to be of benefit, the FDA has speeded up approvals so that most requests are handled within a couple of days and emergency requests are handled almost immediately. In addition to speeding up approvals, the FDA also removed another roadblock to accessibility by approving 99% of the treatments patients and their doctors ask for.

 

Right-to-Try laws have other failings. Specifically, the free pass they give to drug and device companies to refuse to allow compassionate use of their products. “We don’t know how many times requests to drug companies are approved or denied. If the drug company says ‘no,’ that’s the end of it. (Alison Bateman-Houseman). The product of an unholy alliance between libertarian ideologues and Silicon Valley moguls looking for a big score, RTT laws have little to do with compassion, a lot to do with profits and deregulation. Take the FDA out of the transactions between drug companies and desperately ill patients and those patients become pawns in a despicable scheme to create a profitable niche market. Many will eventually find themselves in a never-never land of untested therapies (to be accessible under RTT, treatments must pass only an FDA tier 1 safety screening, the lowest bar and the one least likely to spot potentially life-threatening side effects). The consequences of removing the FDA from the delivery process— increasing the danger to patients of drugs and treatments that have had only limited safety screenings.

 

The real question and the one we ask in every article on the U.S. health care industry — Who benefits? (Someone always does, rarely patients) Chief among the beneficiaries are start-up drug companies funded by (who else) Silicon Valley’s masters of the universe who are neither “patient oriented nor compassionate trying to create buzz for their products.” (Diana Zuckerman, president National Cancer Center for Health Research. Mustn’t forget the 1% who are willing and able to pay for experimental treatment (most health insurers will not pay for treatments that have not gone through the entire FDA review process), and the gaggle of unscrupulous doctors whom the law makes no attempt to rein in leaving them free to charge larcenous prices for administering the treatments. To add insult to injury, as we have noted, in several states RTT laws give insurance companies the right to refuse to cover the costs of treating side-effects associated with these investigational treatments.


What of the major supporter and funder of the bill— the Goldwater Institute? Here’s president Victor Riches “waxing eloquent” on the RTT and the basket of bennies it offers to terminal patients. “There’s no more fundamental right than the right to save your own life. RTT guarantees that freedom by ensuring that patients …are in control of the treatments they receive when facing a terminal diagnosis.” Are they really? Without FDA oversight, patients may be in charge as Mr. Riches contends, but it’s a hollow privilege if the information that would allow them to make a reasoned decision is unavailable. Why is the FDA’s role especially crucial to terminally ill patients? First of all, they’re an independent voice without the vested interes of Pharma or doctors. their investigations may reveal dangerous side-effects and will insure that whatever safety adjustments exist are made in the administration of the drug for patients with multiple health problems. As it stands, RTT laws ignore “key patient protections without actually improving patient access to investigational drugs outside of clinical trials.” (American Society of Clinical Oncology).

 

Why, then, the big push to promote RTT? Does it help to know that one of the major funders of the Goldwater Institute are the ubiquitous Koch Brothers? Their beef? According to Charles Koch in an interview with The Washington Post “  [The FDA makes it] almost impossible to develop new drugs.”  Listening to either Charles or David Koch unload on the FDA explains their support. Like a Trojan horse filled with goodies for oligarchs, RTT legislation is an important piece of the Koch Brothers’ wish list to limit governmental reach, to enshrine deregulation as legitimate economic policy, and to secure immunity for business from consumer lawsuits. The Kochs’ shady ethics and horrendous but well-deserved reputation for despoiling the planet explain their partnership with foundations like the morally bankrupt Goldwater Institute. Their interest has nothing to do with concern for terminally ill patients but underscores a life-long ambition to deal a death blow to government’s ability to rein in the excesses of America’s largest corporate behemoths, starting with Koch Enterprises. RTT laws are a small crack in the wall protecting the people from the opportunists and plunderers trawling in every corner of the U.S. for a big payday in a regulation-free U.S.

 

What can you do about it? If you live in one of the 37 states with existing RTT laws (see below for the list), make sure your local government officials, starting with the Governor, know that the cat is out of the bag. RTT is a thinly-disguised attempt to remove the protections and rights the people have in negotiating their way through a world controlled by power and privilege. Demand that the law be withdrawn.If you live in the thirteen states without RTT laws, thank your lucky stars. Make sure your friends and associates know that RTT laws only benefit the oligarchs looking for a big score and the 1% with the dosh to afford the treatments (providing they can get them). For the rest of us the old rule still applies —if it looks like it’s too good to be true, it probably is.


Beware the drug and tech companies’ sales pitch — “I don’t think a person or an agency has the right to tell that terminally ill person, ‘I’m sorry I don’t think I’m going to let you try this.’”  Don’t fall for it. When the circumstances call for an investigational drug, the answer is not a free-market, unregulated treatment whose main mission is to enrich a drug or device company but an FDA-approved remedy that won’t bankrupt you or your family and will contain the same potentially life-saving benefits.

 

Caveat emptor (let the buyer beware).

 


 

The 37 states that have already passed Right To Try laws —Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wyoming

 

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