{"id":138134,"date":"2021-03-31T11:07:05","date_gmt":"2021-03-31T19:07:05","guid":{"rendered":"https:\/\/lukeford.net\/blog\/?p=138134"},"modified":"2021-03-31T11:10:50","modified_gmt":"2021-03-31T19:10:50","slug":"the-natural-cures-they-dont-want-you-to-know-about","status":"publish","type":"post","link":"https:\/\/lukeford.net\/blog\/?p=138134","title":{"rendered":"The Natural Cures They Don’t Want You To Know About!"},"content":{"rendered":"

Surgeon David Gorski writes<\/a>:<\/p>\n

One of the biggest medical conspiracy theories for a long time has been that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can\u2019t have them because (1) \u201cthey\u201d don\u2019t 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 \u201cnatural\u201d cures or various other alternative medicine cures that are being \u201csuppressed\u201d 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 \u201chealth freedom\u201d movement. who posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA called off, free market innovation would flourish and all these cures, so long suppressed by an overweening regulatory apparatus, the floodgates would open and these cures, long held back by the dam of the FDA, would flow to the people.(Funny how it didn\u2019t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can\u2019t 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.<\/p>\n

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 \u201cright-to-try\u201d laws.<\/p>\n

* 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\u2019s 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\u2019s why, as I\u2019ve 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.<\/p>\n

* Not surprisingly, libertarians are declaring this a big \u201cwin\u201d for patient\u2019s rights. It\u2019s nothing of the sort. The flavor of the arguments can best be seen in two articles from Reason.com\u2019s Nick Gillespie, who is clearly clueless about clinical trials. Basically, he took to Reason.com to gloat<\/a>, referencing an article from over two weeks ago that he entitled The Upside of Ebola (Yes, There May Actually Be One)<\/a>. It\u2019s about as blatant a move to take advantage of the Ebola outbreak to promote bad right-to-try legislation as I\u2019ve ever seen. The subtitle exults:<\/p>\n

\n

\nA rising death toll, mass panic, scary mortality rate\u2014what could possibly be good about the out-of-control epidemic? It may accelerate the adoption of laws giving patients more power.\n<\/p>\n<\/blockquote>\n

Yeah, sure. 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:<\/p>\n

\n

\nEbola\u2019s 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?<\/p>\n

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\u2019t 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.<\/p>\n

You don\u2019t have to be a doctrinaire libertarian\u2014though it helps\u2014to 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.\n<\/p>\n<\/blockquote>\n

Actually, you do rather have to be a doctrinaire libertarian to have a reality distortion field as powerful as Nick Gillespie\u2019s that leads him 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\u2019s rationale is a complete non sequitur<\/em>, 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. Second, I can\u2019t help but note that existing FDA mechanisms got ZMapp to American Ebola patients rather rapidly, no need for right-to-try laws necessary. But excuse me. What Gillespie says is that Ebola and ZMapp are \u201cforcing a conversation.\u201d I suppose that\u2019s true, but it\u2019s the wrong conversation, a profoundly deceptive conversation, in which an advocate of right-to-try laws shamelessly takes plays on people\u2019s fears of Ebola to promote these bad laws. Claiming that there is \u201cno good argument against right-to-try\u201d (wrong<\/a>, wrong<\/a>, wrong<\/a>), Gillespie also shamelessly attacks straw men, representing the primary argument against right-to-try as giving patients \u201cfalse hope<\/a>.\u201d There are lots of other reasons why these are bad laws.<\/p>\n

But Gillespie is just getting warmed up:<\/p>\n

\n

\nBut what\u2019s already cruel is the FDA\u2019s drug-testing process. It\u2019s 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\u2019s every reason to believe<\/a> that the FDA approval process is killing as many or more people than it saves, especially as the FDA doesn\u2019t allow approvals from Europe and elsewhere to stand in for trials here.\n<\/p>\n<\/blockquote>\n

Uh, no. There is not \u201cevery reason to believe\u201d anything of the sort. See? Once again, there\u2019s 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 linkes is entitled Kill The FDA (Before It Kills Again)<\/a>, in which, referencing the movie Dallas Buyers Club<\/em>\u2014which 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)\u2014Gillespie proclaims that the FDA \u201ccontinues 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.\u201d And what is his rationale? Wrap your mind around this:<\/p>\n

\n

\nAs my Reason colleague Ronald Bailey has written<\/a>, this means the FDA\u2019s caution \u201cmay be killing more people than it saves.\u201d How\u2019s that? \u201cIf 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.\u201d\n<\/p>\n<\/blockquote>\n

Completely missing from Bailey\u2019s and Gillespie\u2019s equation is the number of drugs that the FDA doesn\u2019t approve because they don\u2019t 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. Gillespie notes:<\/p>\n

\n

\nA 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 \u201cuncertainty regarding regulatory standards for determining whether a drug should be approved as safe and effective,\u201d a reality that almost certainly made pharmaceutical companies more likely to tweak old drugs rather than go all in on new medicines.\n<\/p>\n<\/blockquote>\n

Notice how this is another non sequitur<\/em> applied to right-to-try laws, given that the answer to this problem would be regulatory clarity, not state-by-state right-to-try laws. Think of it this way: What\u2019s more uncertain? The FDA or having different laws in different states regarding \u201cright to try\u201d? Gillespie\u2019s 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. They are not about helping patients. That\u2019s how they are sold to desperately ill patients, but in reality libertarians like Gillespie and Bailey are using desperately ill patients in the same way that Stanislaw Burzynski is: As a powerful tool to sway public opinion against the FDA and towards their viewpoint.<\/p>\n

There\u2019s a reason that certain aspects of these laws are not as widely emphasized in the PR offensive in favor of right to try. It\u2019s because they are pure \u201chealth freedom\u201d 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\u2019ll notice a number of highly problematic clauses. As I\u2019ve 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.<\/p>\n

More disturbing are the financial aspects. The Goldwater Institute legislative language template<\/a> (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 \u201cdoes 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\u201d 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\u2019s unlikely that government entities like Medicare or Medicaid would do that, but insurance companies certainly will.<\/p>\n

Basically, what this law says is: If you can afford it yourself, no help, you can have it. If not, you\u2019re SOL. As I\u2019ve pointed out, if there\u2019s one thing worse than dying of a terminal illness, it\u2019s 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\u2019s 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\u2019s 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<\/a>. After all, his antineoplastons would qualify just fine under right-to-try laws if they\u2019re 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.<\/p>\n

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 \u201ckilling us.\u201d 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<\/a> to pressure the federal government to weaken the FDA.<\/p>\n

In the end, though, right-to-try laws are what I like to call \u201cplacebo\u201d laws in that they make people who pass them and support them feel good but don\u2019t 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. The FDA also 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 state right-to-try laws. It\u2019s to address the issue at the federal level. I\u2019ve 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\u2019ve seen too many of them. Right to try and similar misguided efforts, however, are not the way.<\/p>\n","protected":false},"excerpt":{"rendered":"

Surgeon David Gorski writes: One of the biggest medical conspiracy theories for a long time has been that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can\u2019t have them because (1) … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[42886],"tags":[],"class_list":["post-138134","post","type-post","status-publish","format-standard","hentry","category-fda"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t