Rick Snyder at 2011 Michigan Gubernatorial Inauguration

Rick Snyder at 2011 Michigan Gubernatorial Inauguration

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.

Unfortunately, two weeks ago, the cruel sham that was the Michigan right-to-try bill was passed into law and signed by Governor Rick Snyder. It’s rather interesting how this came about. Senator John Pappageorge introduced Senate Bill 991 in the Michigan Senate over the summer. There was very little news coverage, which I considered odd, given the heavy news coverage of right-to-try bills in other states. In fact, I only happened to hear that the Michigan right-to-try bill had even been introduced into the Senate when a colleague whose job in part happens to involve dealing with the legislature gave me a heads up. I also learned from asking around that, in addition to home grown patient advocates supporting the bill, there was a flack from the Goldwater Institute flown in to testify and that no one from Michigan universities or academic medical centers was particularly eager to testify against the bill due to the expected backlash.

As I’ve said many times before, both in posts about right to try and about Stanislaw Burzynski, I can totally understand the patient impetus for these laws, given that I have had family members with terminal illnesses. Unfortunately, however, forces like the Goldwater Institute are taking advantage of the very human desire not to die and not to be forced to watch one’s loved ones die, all in order to push bad legislation. Indeed, the Goldwater Institute uses terminally ill patients desperate for their lives in much the same way Stanislaw Burzynski uses them: As shields and weapons in their battle against the FDA and state medical boards. That’s why, as I’ve morbidly joked before, being against right-to-try in the eye of the public is not unlike being against Mom, apple pie, the American flag, and puppies, hence the reluctance of even doctors doing clinical trials to publicly voice opposition. The most predictable attack against anyone who dares to publicly oppose these bills has been to portray opponents as not just callous, but as practically twirling their mustaches with delight and cackling evilly while watching terminally ill patients die without hope. (I exaggerate—but only slightly.) Few are the physicians and scientists (and even fewer still the medical centers and universities) who want to risk being portrayed that way, and one person who did testify against the bill reported enduring withering looks from patient advocates there to testify for the bill, who, like Burzynski patients and families, really do view opponents of right-to-try as enemies actively seeking to cause harm and to prevent them from saving their lives or the lives of family members.

Before I knew it, Senate Bill 991 had passed overwhelmingly. So, seeing what was coming next, I wrote to my House Representative to urge that he oppose the bill, House Bill 5651. He was receptive and a little surprised that anyone would be against the bill, but he admitted that my arguments made him think. Even so, I was under no illusion that he was likely ever to vote against it. He didn’t. Because it was too late and the law had already been passed by the senate, making writing to my state senator (whom we’ve met before) pointless, I instead wrote his opponent running for his State Senate seat, because (1) she is in the House and could still affect the outcome and (2) perhaps she wanted to hear from someone considering voting for her. I never got a response; so at least in that aspect my Representative did better. At least he listened and responded. None of it, whether it came from me or the feeble opposition, mattered. It is, after all, an election year, and every single one of these legislators, as well as Rick Snyder, are running for election or re-election. On October 1, House Bill 5651 passed the House unanimously and was signed by Governor Rick Snyder on October 17. Interestingly, despite my having tried to pay close attention to news reports and House activity, I only learned of this a week ago, when news stories noted that Snyder had already signed the bill! There was virtually no discussion and very little news coverage. The fix appeared to have been in, as this bill passed with about as close to zero news coverage as I’ve seen for a bill this major in every other state where it’s appeared.

Not surprisingly, “health freedom” advocates and some libertarians are declaring this a big “win” for patients’ rights. It’s nothing of the sort. The flavor of the arguments can best be seen in two articles from Reason.com’s Nick Gillespie, who is clearly clueless about clinical trials. Basically, he took to Reason.com to gloat, referencing an article from over two weeks ago that he entitled “The Upside of Ebola (Yes, There May Actually Be One)“. It’s about as blatant a move to take advantage of the Ebola outbreak to promote bad right-to-try legislation as I’ve ever seen. The subtitle exults:

A rising death toll, mass panic, scary mortality rate—what could possibly be good about the out-of-control epidemic? It may accelerate the adoption of laws giving patients more power.

So let me get this straight. Thousands of people are dying of a horrible disease in Africa while people in the U.S. are freaking out about the possibility of the virus causing outbreaks right here at home, and Gillespie sees these events, apparently more than anything else, as an opportunity to push his libertarian agenda with respect to medicine. No one would be that cynical, would he? Wrong:

Ebola’s arrival and seeming spread in America is causing mass panic, tasteless Internet jokes, and incredibly poorly timed magazine covers. Can anything good come out of the disease, which has no known cure and a terrifying mortality rate of 50 percent?

Yes. To the extent it forces a conversation about the regulations surrounding the development of new drugs and the right of terminal patients to experiment with their own bodies, Ebola in the United States may well accelerate adoption of so-called right-to-try laws. These radical laws allow terminally ill patients access to drugs, devices, and treatments that haven’t yet been fully approved by the Federal Drug Administration and other medical authorities. The patients and their estates agree not to bring legal action against caregivers, pharmaceutical companies, and insurers.

You don’t have to be a doctrinaire libertarian—though it helps—to see the value in letting people with nothing left to lose experiment on themselves. They may get a new lease on life. The rest of us get meaningful information that may speed up the development of the next great medical intervention.

Actually, you do rather have to be a doctrinaire libertarian to have a reality-distortion field as powerful as Nick Gillespie’s to write drivel like this. Ebola and right-to-try laws. Hmmmm. How is one thing not like the other (or not related to the other)? First of all, Gillespie’s rationale is a complete non sequitur, clearly designed to take advantage of the Ebola panic to persuade people that right-to-try laws are a good idea, even though such laws would not have had one whit of an effect on the odd patient in the US who might be infected with Ebola. After all, Ebola, as deadly as it is, is not a terminal illness. With good supportive care, around half, possibly more, survive the disease. Second, I can’t help but note that existing FDA mechanisms got ZMapp to American Ebola patients rather rapidly, even briefly bypassing phase 1 studies, no need for right-to-try laws necessary. But excuse me. What Gillespie says is that Ebola and ZMapp are “forcing a conversation.” I suppose that’s true, but it’s the wrong conversation, a profoundly deceptive conversation, in which an advocate of right-to-try laws shamelessly takes plays on people’s fears of Ebola to promote these bad laws. Claiming that there is “no good argument against right-to-try” (wrong, wrong, wrong, wrong), Gillespie also shamelessly attacks straw men, representing the primary argument against right-to-try as giving patients “false hope.” There are lots of other reasons why these are bad laws.

But Gillespie is just getting warmed up:

But what’s already cruel is the FDA’s drug-testing process. It’s massively expensive and overly long, costing between $800 million and $1 billion to bring a drug to market and taking a decade or more to complete the approval process. There’s every reason to believe that the FDA approval process is killing as many or more people than it saves, especially as the FDA doesn’t allow approvals from Europe and elsewhere to stand in for trials here.

No. Just no. There is not “every reason to believe” anything of the sort. See? Once again, there’s the myth that there are all these fantastic cures out there that the FDA, through its bureaucratic inertia, is keeping from you. I am rather grateful, though, that Gillespie, through his link, makes his intent very clear. The article to which he links is entitled “Kill The FDA (Before It Kills Again).” In the article, referencing the movie Dallas Buyers Club—which I finally saw on cable and was surprised to find that, leaving aside its historical inaccuracies about the AIDS epidemic in the 1980s, taken just as a movie it was at best just OK (I was seriously disappointed)—Gillespie proclaims that the FDA “continues to choke down the supply of life-saving and life-enhancing drugs that will everyone agrees will play a massive role not just in reducing future health care costs but in improving the quality of all our lives.” And what is his rationale? Wrap your mind around this:

As my Reason colleague Ronald Bailey has written, this means the FDA’s caution “may be killing more people than it saves.” How’s that? “If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”

Completely missing from Bailey’s and Gillespie’s equation is the number of drugs that the FDA doesn’t approve because they don’t show efficacy and safety that could allow even more than those 20,000 people a year to die or even actively kill some of them. As conceded by even Bailey, it was the FDA that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world. Bailey’s argument is, at best, tenuous, at worse misleading. (I favor worst. It’s just plain misleading.) Gillespie notes:

A 2006 Government Accountability Office (GAO) study found that the number of new drug applications submitted to the FDA between 1993 and 2004 increased by just 38 percent despite an increase in research and development of 147 percent. The mismatch, said GAO, was the result of many factors, ranging from basic issues with translating discoveries into usable drugs, patent law, and dubious business decisions by drug makers. But the problems also included “uncertainty regarding regulatory standards for determining whether a drug should be approved as safe and effective,” a reality that almost certainly made pharmaceutical companies more likely to tweak old drugs rather than go all in on new medicines.

Notice how this is another non sequitur applied to right-to-try laws, given that the answer to this problem would be improving regulatory clarity, not passing state-by-state right-to-try laws. Think of it this way: What’s more uncertain? The FDA or having different laws in different states regarding “right to try”? Gillespie’s citing his previous article claiming that the FDA is killing you in an article promoting right-to-try is a very good indication what these laws are really about. Let’s be very, very clear here. They are not about helping patients. That’s how they are sold to desperately ill patients, which is why I must repeat: In reality libertarians like Gillespie and Bailey are using desperately ill patients in the same way that Stanislaw Burzynski uses his patients: As a powerful tool to sway public opinion against the FDA and towards their viewpoint.

There’s a reason that certain aspects of these laws are not as widely emphasized in the PR offensive in favor of right to try. It’s because they are pure “health freedom” and libertarian wingnuttery. For example, if you look at the Goldwater Institute template for right to try laws, which, unfortunately, has been the basis of every right to try law passed and under consideration, you’ll notice a number of highly problematic clauses. As I’ve discussed multiple times, there is the requirement that the drug or device has only passed phase 1 trials, which, given how few drugs that have passed phase 1 actually make it through to approval, is a really low bar, especially since most phase 1 trials involve fewer than around 25 patients.

More disturbing are the financial aspects. The Goldwater Institute legislative language template (to which the Michigan legislation is virtually identical) allows drug companies to charge patients, with no provision to help patients pay for exercising right-to-try. Indeed, it specifically states that the bill “does not require any governmental agency to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device” and that insurance companies do not have to pay for costs associated with the use of such therapies. You know what this means? Insurance companies could refuse to pay for care related to complications that might occur because of experimental treatments. You use an experimental drug and suffer a complication? Too bad! Your insurance company can cut you off! Now, it’s unlikely that government entities like Medicare or Medicaid would do that, but insurance companies certainly will.

Basically, what this law says is: If you can afford it yourself, no help, you can have it. If not, you’re S.O.L. As I’ve pointed out, if there’s one thing worse than dying of a terminal illness, it’s suffering unnecessary complications from a drug that is incredibly unlikely to save or significantly prolong your life and bankrupting yourself and family in the process. Right-to-try encourages just that. What’s more compassionate? Attacking the FDA and degrading the approval process that requires drug safety and efficacy while dangling false hope in front of patients or standing up and protecting patients from the harm such a policy could cause? Let’s just put it this way: I predict that Stanislaw Burzynski will soon be sending antineoplastons to patients in right-to-try states if, as he keeps bragging, the FDA has allowed him to reopen his clinical trials. After all, his antineoplastons would qualify just fine under right-to-try laws if they’re back under clinical trial. Indeed, if there’s one thing the decades-long battle between the FDA and Burzynski tells us, it’s that the FDA actually bends over way too far backwards to allow manufacturers of dubious drugs to prove themselves.

Finally, the anti-FDA rhetoric, such as linked to by Gillespie, is a very good indication that the true purpose of right-to-try legislation is to neuter the FDA’s power to control drug approval, thus greatly loosening or even eliminating hurdles to the drug approval process. It is no coincidence that the strongest, richest, and most vocal proponents of these laws are the Goldwater Institute and libertarians like Nick Gillespie and Ronald Bailey, who, not coincidentally, think that the FDA is “killing us.” Those articles are a definite “tell.” It’s also clearly a strategy to get right-to-try passed in as many states as possible and get referendums passed by wide margins to pressure the federal government to weaken the FDA.

In the end, though, right-to-try laws are what I like to call “placebo” laws in that they make people who pass them and support them feel good but don’t actually address the problem that they are supposedly intended to address. Drug approval regulatory authority lies with the FDA; it could completely ignore state right-to-try laws. Even supporters realize this and realize that there will likely lead to a “long, drawn-out court battle over state vs. federal sovereignty.” The FDA also already has a compassionate use program and rarely turns down such requests. Admittedly, the application process is long and probably too onerous, but the answer to that problem is not to pass state right-to-try laws. It’s to address the issue at the federal level. I’ve also said in an interview that, now that my state government has foolishly passed a right-to-try law, one of two things is likely to happen: Either nothing, because federal authority trumps state authority, or disaster for patients, doctors, and, yes, biotech and drug companies. Everybody, myself included, wants to help terminally ill patients. After all, I’ve seen too many of them. Right-to-try and similar misguided efforts, however, are not the way.



Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.