Trudy Lieberman has an important post on a story that has gone below the media radar, on how a bill based on the bogus premise that the FDA is impeding terminal patients’ ability to get access to experimental drugs, is moving forward in Congress and garnering unwarranted favorable commentary. Here is her overview:
Right before Congress adjourned for the August recess, the Senate rushed through “right to try” legislation that its sponsor Sen. Ron Johnson of Wisconsin argued gives terminally ill patients the “right to access treatments that have demonstrated a level of safety and could potentially save their lives.” Johnson was selling hope, a commodity never in short supply in America’s bag of marketing tricks. He also was selling something else–a way to circumvent the FDA’s role in a process that has been in place for several decades that lets very sick people try experimental approaches not yet on the market…
But the legislation, on its way to possibly an early vote in the House of Representatives in the next few weeks, eliminates the FDA in the process and with it any protections patients might have.
This might sound fine and logical if you don’t know the fact. The FDA already has a process for approving the experimental drugs for the terminally ill. The process is fast, with emergency sign-offs in 24 hours and the rest processed in 3-4 days. 99% of the applications are approved. So the idea that this is a problem is simply not true. Moreover, when there is a hangup, it’s typically that the drugmaker doesn’t want the use approved.
In addition, the FDA also provides useful input in these cases:
For example, the FDA may know about other drugs in the same class as the experimental approach and can warn of problems that have arisen with those drugs. It also can ask for safety adjustments in administering the experimental drug. For example, should the dosage be changed, or is a heart monitor needed?
On top of that, there are downsides to patients who go outside the FDA approved process:
…few patients in the 37 states that have adopted such laws are likely to know they may lose hospice coverage or they may be denied coverage for home health care if they are using an experimental drug. In Colorado, Connecticut, Oklahoma, and West Virginia, patients may lose their health insurance. Their coverage may be denied for six months after the experimental approach ends.
Lieberman describes how the legislation did get some good coverage when it was first proposed by the Washington Post, Vox, MedPage Today…in other words, stories oriented towards DC or medical industry insiders. And they were skeptical of the need for the bill. There was some cheerleading reporting in Johnson’s state of Wisconsin. Reporting was otherwise spotty to non-existant, save some op-eds also backing the proposal.
What interests me as least as much as Lieberman’s story is who might be behind this campaign to curb the FDA’s role. And it isn’t Big Pharma.
Admittedly, there is a clear moving force. An organization called Goldwater Institute, “a libertarian think tank,” is the leader of the campaign for this bill and similar legislation passed in 37 states. But even though individuals can have pet causes, it seems to be peculiar to be fixated on one where the driver has to be opposition to the FDA, as opposed to the issue at hand, since the notion that the FDA is a problem here does not stand up to scrutiny. In other words, this effort looks to be more about legitimating the use of experimental drugs and not about concern for the terminally ill.
And who might be in favor of that? Liberman again:
Who might benefit then, if not the drug companies? The organization Who.What.Why. reported that new drug startups might be interested in creating buzz for their products and finding a new revenue source–wealthy patients who can pay for their super-expensive experimental medicines. Dishonest doctors might be interested, too, in the fees they could collect for monitoring patients who use these drugs.
And who is the money behind “new drug startups”? Silicon Valley. Let us not forget that it was the FDA that effectively put an end to one-time tech darling Theranos. Peter Thiel, who is trying to live forever by getting blood transfusions from young people, has also been trying to pressure the FDA by launching an ethically questionable, non-FDA approved herpes vaccine trial in St. Kitts. But it’s hard to take that particular effort to challenge the regulator seriously, since his unapproved human “trial” had a grand total of 20 participants. Not only did the St. Kitts government launch an investigation, but the press uproar over the trials led to a climbdown within days. From CNBC:
The CEO of a herpes vaccine company at the center of a controversy over an offshore clinical trial on Friday said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel.
In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford’s decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board (IRB), as is traditional.
Orc at Science Blogs connected the dots between the dodgy “right to try” legislation for the terminally ill and the broader libertarian war against the FDA. Forgive me for quoting at length:
I’ve also caught flak for characterizing right-to-try as being part of a broader war against the FDA (indeed, as part of a broader war against regulation in general) by libertarian-leaning free market fundamentalists, some of whom claim (literally) that the FDA is killing people. Lots of people. How can you say that? proponents of right-to-try would ask, drawing themselves up in their best self righteous fury. This is about helping terminally ill patients! Maybe. But, as I’ve said before, the FDA already has a Compassionate Use program that achieves the same purpose and rarely turns requests down, a program that’s been improved over the last couple of years to be speedier and more responsive, with much less application time. Consistent with its libertarian origins, right-to-try tries to cut the FDA out of decisions between a drug seller and patients, but at the cost of eliminating many protections for patients. For instance, unlike the case in “expanded access” or “compassionate use,” the institutional review board (IRB), an ethics panel that oversees clinical trials does not oversee patients in right-to-try. There is no financial help; so only patients whose families are rich or can raise a lot of money fast are likely to be able to benefit. Even worse, as I’ve described, most right-to-try bills not only do not require insurance companies cover experimental therapeutics (and why should they?), but allow insurance companies not to cover charges for complications from using experimental therapeutics. However, perhaps the most egregiously false argument made by right-to-try advocates is that the laws’ allow use of experimental therapeutics after they’ve been “proven safe” through phase I testing. Yes, you read that right. 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.
Although not commonly seen as such, right-to-try laws are of a piece with libertarian and radical fundamentalist free market views, some of which claim that the FDA is basically unnecessary or that its role should be vastly constrained. You can see it all there: Minimal requirements for safety testing (phase I), no ethical oversight, the decision entirely up to the company and patient, and, of course, the patient is totally on his or her own. People with such views were even in consideration for the post of FDA Commissioner, for example, two cronies of the aforementioned Peter Thiel, both of whom believe that the FDA stifles their holy grail of “innovation.” The first was Jim O’Neill, who has advocated that the FDA test new drugs only for safety, not efficacy, thus returning the FDA to its pre-1962, pre-thalidomide role. The second was Balaji Srinivasan, a Silicon Valley entrepreneur who advocated basically doing away with the current system of FDA regulation and replacing it with online reviews, basically a Yelp or Über for drugs and medical devices. When asked “How do you prevent quacks?” Srinivasan replied, “Scaled Internet reputation systems. Works at massive scale in other areas.” So clueless were both of these men that it was a relief when a relatively normal Republican pharma shill named Scott Gottlieb was ultimately appointed. He was the “least bad,” most conventional choice, someone any conservative Republican administration might have appointed. Yes, he wants to “streamline” the process by which, for example, vaccines are approved, but he’s actually pretty conventional. He’s even decided to http://www.npr.org/sections/health-shots/2017/08/28/546719842/fda-cracks-down-on-stem-cell-clinics-selling-unapproved-treatments.
Stymied at the FDA, apparently Peter Thiel is now waging his war on the FDA by other means:
Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.
The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.
Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.
“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”
Indeed it is. What Peter Thiel and Rational Vaccines, a company founded by Agustín Fernández III and William Halford (formerly of Southern Illinois University who died recently of cancer) did and are doing is patently unethical—shockingly, horrifyingly so. The very function of the IRB is to protect human subjects in clinical trials. Usually, when a clinical trial is proposed, it goes through two committees, first the scientific review board, or SRB, which determines whether the trial is scientifically justified and soundly designed. The second is the IRB, which is charged with protecting the human subjects. Its function is to examine the clinical trial design and to determine whether it is ethical and whether the risks to human subjects do not outweigh the potential benefits; e.g., that there is clinical equipoise. Once it approves the trial, the IRB continues to monitor the trial, examining reports of adverse events, both serious and minor, and sometimes demanding changes in the trial or even canceling it if it judges that there are too many adverse events or that one group is doing so much better than the other group that it would be unethical to continue the trial. These protections for human subjects flow from the Belmont Report and the Common Rule, both of which were designed to prevent the abuse of human research subjects like what the Nazis did and underlie all the federal regulation regarding human research protection. Unfortunately, these protections are not universal, as they only apply to organizations with federal funding (such as universities) or entities applying for FDA approval for one of its investigational drugs or devices.
Like right-to-try, Peter Thiel’s and Rational Vaccines’ offshore clinical trial of a new herpes vaccine is an attack on the FDA. Libertarians and free market fundamentalists even admit as much:
The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.
“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”
In other words, while I haven’t looked into whether there are direct ties between the Silicon Valley FDA opponents and the Goldwater Institute, they are at a minimum fellow travelers. And even though Thiel’s herpes vaccine gambit backfired, don’t expect him and his allies to give up easily.
And in case you need a reminder as to why rich men need to be protected from themselves, let me hoist some text from a 2008 post:
Consider the sad fate of Eben Byers, an athlete, industrialist, and man about town of the 1920s. After sustaining an arm injury that refused to heal, his doctor prescribed (and received a 17% patent rebate on) a patent medicine. Eben thought it did him a great deal of good and began taking the potion two to three times a day.
The drink, Radithor, was radium dissolved in water. Byers lost his teeth and most of the bone mass in his jaw, and before his death, developed abcesses on his brain and holes in his skull. But the maker of the toxic potion was never prosecuted, since selling radium drinks was not against the law.
By the time Byers had the vast misfortune to happen upon Radithor, the risks of radium were coming to light, as factory workers who painted radium onto clocks and would use their lips to establish a point on their brushes were developing lip and mouth cancers. But the potion-makers nevertheless continued to sell their tonics until the Byers death killed the industry.
Byer’s horrific and widely-publicized death was the impetus for greatly strengthening the powers of the FDA. But at least poor Byers experimented only upon himself. Thiel is perfectly comfortable with turning people into his guinea pigs.
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One word: Thalidomide.
https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
“In July of 1962, president John F. Kennedy and the American press began praising their heroine, FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus.”
I went to high school with a Thalidomide Baby. She had one complete leg. That was it.
How she managed to navigate our school with two artificial arms and a leg was beyond me. She also was an excellent student.
The downside? According to my mother, who taught at that school, Shari had no friends. None. And it wasn’t like she was a nasty person. Far from it.
My doctor was a Thalidomide Baby – he’s a brilliant doctor, the best I’ve had. Most of his patients are from the very poorest areas of the city and are largely drug addicts and the homeless. He’s also a paraolympian, a great athlete (sailing). He is very inspiring, but it is infuriating that so much damage was caused by greed and ineptitude.
Flora: Thank you! The history of Radithor and Thalidomide ought to make the rejection of “right to try” legislation a slam dunk. Oddly, there are three “right to try” bills in the Congress.
This one passed the Senate: S. 204
Two bills introduced in the House:
H.R. 878
H.R. 2368
Is Peter Thiel (acting through someone who is as equally amoral and nutty, Ron Johnson) trying to “jailbreak” the FDA?
Hmm. Thanks for this. Another “reform” that isn’t a reform. I note the presence of undesirable immigrant Peter Thiel, but let’s not gloss over the mention of the Heartland Institute, climate-change-deniers extraordinaire–which further implicates this Bartley Madden. And as many have pointed out, climate-change deniers usually have financial reasons for their denial, something Naomi Klein summarizes in her recent books and inteviews.
Hedge funds are buying up drugs and selling them at outrageous prices – even generics. They’re pressuring the FDA to let them into sales faster using terminal illness as an excuse, but without proper data you don’t know risks or benefits – and I say this as someone who would be happy to see more cheap generics thrown at cancer even without formal per se testing (e.g., metformin, hydroxycitrate, cannabidiol, dehydroascorbate). But many of these items have been in use for long periods and thus are relatively safe and cheap.
So hedge funds are buying up patented molecules like inflated mortgage bonds in 2006 and they need regulatory forbearance to fully monetize.
There are actually two trends here that matter. It’s not enough to open the gold rush on expensive, experimental chemicals. You also have to shut down the generic competition so patients have no other alternative.
I’ll give you two examples.
They’re transfering dubious patents to Indian tribes now to use sovereign immunity to avoid fast-tracked patent reviews. Witness the recent deal with the Mohawks over Restasis to thwart generic competition. (At some point if you let sovereign entities seize public domain chemicals from public use with an invalid patent, doesn’t this ever become an emminent domain issue?)
The second one is much less well known because it involves an industry that advertises, Big Pharma, pitted against one that can’t, the compounding pharmacies. The FDA has *vastly* restricted the chemicals that compounders can use, banning them even from using simple fillers and nutrients available throughout the food industry and drug manufacturers. It’s making it impossible to fill uncontroversial scripts for cancer treatments, enteral feeding – almost everything you can imagine is threatened. Imagine having to run a simple vitamin shot through an expensive clinical trial to prove that it addresses a deficiency and you start to get an idea of the road blocks being thrown up.
The entire committee that makes these decisions is composed of Pharma people who appear to be simply shutting down anything that their “rivals” use – even when there’s no other source of treatment for these conditions, even if it’s sold over-the-counter with *looser * regulations. There isn’t a doctor or a patient or manager who uses compounded medicine on the committee. They’ve been getting screamed at for a year now, but nothing surfaces in the press (wonder if it has something to do with those corporate advertiser disparagement clauses at certain newspapers).
The compounding industry is the last place outside the Pharmacy Benefit Managers price-fixing/kickback chain that can buy raw chemicals straight from FDA-inspected manufacturing facilities, repackage them and then provide them to patients. They’re also not well organized politically, meaning they lack the vertical industrial organization that politicians favor for rent-extraction. For these reasons, the pressure on them is intense.
Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) recently introduced legislation that would allow more meaningful patient access to compounded medications: H.R. 2871, the Preserving Patient Access to Compounded Medications Act of 2017.
https://www.nytimes.com/2017/08/06/health/prescription-drugs-brand-name-generic.html
https://www.nytimes.com/2017/09/11/health/cancer-drug-costs.html
Just another example of profiteering in end of life care…
…Great to see comments back! As a reader I see them as a privilege not a right, so understood the reasoning behind the hold.
Let’s face it, most people are afraid of death. It also appears that the wealthy Silicon Valley elites are terrified of the idea, such that we have billionaires funding all sorts of life-extending experiments ranging from freezing to gene meddling. Maybe Thiel’s philosophical question is simply; “What’s the point of being wealthy if one cannot live forever?” or something like that.
Sadly, if this law passes – hard to expect it to not pass given the current climate in DC – Thiel will enable wealthy people to drain their portfolios vainly trying to outrun the Grim Reaper, while also punching a hole in FDA safety regulation that put big pharma in the position of being able to sell extremely costly lottery tickets (prescriptions) – with the same odds of winning.
This is a very important article, thanks for posting. I’ve noticed a lot of nightly news stories on TV towing the FDA deregulation line. Not surprising, since every other ad run during these programs is for some sort of pharmaceutical…
For example, CBS nightly news ran a story last year spewing this “FDA killing patients through over regulation” nonsense. They were profiling Eteplirsen, a treatment (not cure) for Duchenne Muscular Dystrophy. Basically it was/is claimed to extend the amount of time children with the disease can walk before their muscle degenerate. The segment followed two boys with the disease and their mother as they head to the evil FDA advisory committee that ends up rejecting the drug (https://www.cbsnews.com/news/fda-panel-rejects-pleas-of-parents-whose-children-suffer-from-fatal-disorder/).
CBS mentioned the small sample size as a reason for the rejection, but thats it. Whats missing from the story is that Sarepta only tested the drug on 12 boys, data was compared to historical data from boys with the disease in Italy and Belgium, and that distance walked was within normal variation for the disease. (NYT: https://www.nytimes.com/2016/04/26/business/muscular-dystrophy-drug-fda-sarepta-eteplirsen.html?mcubz=3).
This whole story is anecdote over data. The way CBS reported this story was incredibly irresponsible but hey, it makes their sponsors happy so what do they care.
I think we need to look at this from a broader perspective. I get what the FDA/Heath Canada/NHS does, I understand that we need protection from Snake Oil salesmen, and bad drugs, but it is absolutely imperative we get biotech producing cures, and the FDA is not keeping up with the needs of our changing society.
I think we as a collective need to get on top of the FDA, Health Canada, NHS etc. We need to increase funding to them if needed so they stay cutting edge of new technology and treatment options.
Our demographics are pushing us into a corner. As far as I’m concerned, its not just about Silicon Valley types wanting to “Live Forever”, this is about crushing societal costs and demographics.
The first Boomers are turning 71 this year.
We’re soon going to have 3 working age people for every pensioner over 65.
The costs of the Diseases of Aging are astronomical and its absolutely crucial we find ways to alleviate suffering.
I’m going to take a look at Alzheimer’s disease.
It effects 1 person out of 11 over the age of 65. and the risk for dementia doubles every five years after age 65 (Chief risk factor for dementia is age). This goes up to 1 in 3 if you are over 80 (And more and more of us are reaching those ages).
It takes a drug through normal channels 15-20 years and 1.5-3 billion dollars to bring a drug through regulatory hurdles and make it to market.
Every single drug for AD has failed. EVERY ONE. There is no treatment, there is no way of slowing it down, and the societal costs are staggering. All the nodding heads in the Medical community thought that Amyloid Plaques and Neurofibrillary Tangles were the cause of AD. When big pharma designed drugs to clear these plaques, they worked very well! They were able to remove the plaques, however none of the patients recovered.
So, for us to formulate a new approach, test it in animals, jump through the regulatory hurdles and make it to market, we are looking at another 10-20 years, and several more billions. This is a problem on multiple levels….
1) Drug development costs are unsustainable, and need to be brought down. The high cost is primarily because of FDA trials, especially Phase 3.
2) If the oldest boomers are turning 71 now, do we have time to develop these drugs using the normal pathway? Even with new accelerated approvals we still miss the window and the number of patients is going to grow out of hand fast. What about the other diseases of aging like Cancer? Heart disease? Diabetes? Are our medical systems set up to handle the grey-wave heading right at them like an asteroid?
The high costs of drug development prevent multiple pronged attacks and reduced odds of finding an actual cure or solution.
How do we solve these problems? Do we start turning the elderly into Soylent? Should we just stop funding for all treatments for diseases of aging and pursue a strictly palliative cost-saving structure? What is palatable as a society? Can we afford the growing swaths of elderly with a shrinking worker base? And of these younger workers, how willing are they to pay the bills for their elders? Do they wan’t out of the social contract and are they willing to accept their fate when its their turn to get sick and die? Do they have the jobs needed to support an aging population?
These are unpleasant conversations, but the numbers are unforgiving.
AD, Cancer, heart disease, etc etc etc… all of these diseases of aging have one common link. Risk increases as you age. There are several highly credible doctors and scientists who believe we should be treating aging as a disease. I happen to agree! It makes sense! You really are just trading one disease for another as you get older. Like a leaky ship, plug one hole and two more pop up. There are already treatments that can increase “Health Span” in every animal they tried it on. Metformin and Rapamycin are low-hanging fruit, already approved by the FDA, and could improve the quality of life for millions, yet we can’t get them because Aging is not considered a disease by the FDA. So, millions suffer and will for decades before they shuffle off their mortal coil. Here’s the best part… you are next. How do you want this to work out?
The stunning lack of logic at the FDA is where the insanity lies, and it needs to change yesterday.
I hope this doesn’t come off tin foily. Anyone with an interest in Alzheimer’s or dementia might want to take a look at the possible links to the group of chronic infections that many doctors (and the CDC) do not even know exist, i.e., those transmitted by ticks. Lyme and co-infections. It can be absolutely devastating but can also go unnoticed for years and decades. And it definitely causes dementia in some patients…
The controversy surrounding this disease (or group of diseases), and the lack of knowledge or answers in the mainstream medical profession, touches on almost every flavor of corruption covered by this esteemed blog.
It’s getting attention some though:
https://www.nysenate.gov/committees/task-force-lyme-and-tick-borne-diseases
Kris Kristofferson, for example.
“Every single drug for [Alzheimer’s disease] has failed. EVERY ONE. There is no treatment.”
This statement is simply not true. There are many treatments and preventatives.
There’s now strong evidence that, like most autoimmune and insulin resistance conditions, Alzheimer’s is caused by damage to the gut – deworming, broad-spectrum antibiotics and fiber-free food.
I’m pressed for time, but if you do the following literature searches on either Alzheimer’s or amyloid, you’ll see that the following items are quite helpful:
– ketogenic diet/MCT oil (the trial on this is over ten years old; you don’t hear about it because the sugar industry doesn’t want to tell you their products are giving you Alzheimer’s and that it’s carbs, not fats, causing the problems (except, of course, transfats))
– intermittent fasting (same deal)
– benfotiamine (extremely promising recent results, but it’s off-patent so there are no monopoly rents and thus advertisers only have an interest in making sure you don’t hear about it – which they’ve done really, really well much overlap between thiamine deficiency and Alzheimer’s)
– exercise (because the gym teacher’s lobby in Washington is so incredibly corrupt and inept – oh, wait. There isn’t one of those. Which explains why you haven’t heard how beneficial physical exercise is)
– Vitamin D3/cathelicidin (inhibits herpes and amyloid plaque formation [PMID 23322908, 22306846]
– GLP-1/incretins (produced when omega-3 fatty acids and inulin/fiber are digested; inhibits adverse amyloid processing)
To be fair, the New York Times has covered the links with deworming and exercise recently.
And the infections linked to Alzheimer’s are herpes and Chlamydia, not Lyme [PMID 15172740] (Itzhaki & Wozniak). The genes used by herpes and affected in Alzheimer’s are strikingly similar.
What you see on TV and in “the press” isn’t medicine. It’s what people use as an excuse to make money off sickness. If you’re lucky, sometimes they overlap.
Stopping most Alzheimer’s cases from ever developing is cheap and easy. We, as a society, just don’t do it. The same is true for most cancer, obesity, diabetes and even acne.
Dear Lord.
Early-onset Alzheimer’s seems to be entirely genetic, while late-onset is primarily so. Period.
https://www.nia.nih.gov/health/alzheimers-disease-genetics-fact-sheet
Yes, some of the triggers for the relevant genes to start expressing could be things like herpes and chlamydia — or maybe not. Yes, exercise and healthy living so as to minimize cell damage are good. But slugging down large doses of vitamin D and other pills from the health-food store is not a sensible prophylactic measure.
> he first was Jim O’Neill, who has advocated that the FDA test new drugs only for safety, not efficacy, thus returning the FDA to its pre-1962, pre-thalidomide role.
If anything, it seems like the efficacy of already-approved drugs is quite questionable particularly in regards to specific issues (mental health, chronic pain).
Good to have comments back.
What is interesting is that although the FDA does not have a specific time sensitive approval process for compassionate use of an Investigational Drug, it does provide guidelines for how medical institutions are to utilize their own IRB to approve such an occurrence. For example, let’s say there is an IND for a cancer diagnosis and the patient’s family member demanded the use of the IND. This does not require FDA approval. It requires institutional IRB approval, which may or may not grant this request depending on the IRB discussion and Ethics consideration. The data also cannot be used for data collection as most times the patient’s clinical condition does not meet enrollment criteria.
This assault on the FDA seems more like the ‘hijacking’ of the FDA to override institutional IRB. There is no scientific basis of weakening the FDA mandate.
In the meantime, the FDA has a knack of ignoring untoward side effects of approved treatments.
I am 59, and supposedly in the bell shaped curve for having “senile” (age related) cataracts. The other variable is my LASIK surgery, performed in 2001. Last year, the Journal of Refractive Surgery published a study concluding, “Patients with a history of microkeratome-assisted LASIK under-went cataract surgery a decade sooner than patients with similar demographic and ocular characteristics.”
https://www.healio.com/ophthalmology/journals/jrs/2016-5-32-5/%7B980856ce-fd58-4f88-8d04-2ca82f4bde5a%7D/the-effect-of-lasik-on-timing-of-cataract-surgery
In 2014, the former FDA chief of ophthalmic devices, Morris Waxler, Ph.D., said the agency caved to pressure from the ophthalmology medical cartel to approve LASIK and called for FDA-approval of LASIK to be withdrawn. http://lasikcomplications.com/FDA-letter-to-Waxler-denying-petition.pdf
Needless to say…
Herpes is a latent, cell-infecting virus:
There’s a very good reason that ‘attentuated live virus’ vaccines are not a very good idea for this type of virus. There’s a chance that the attenuated virus can replicate in the human body after vacccination and revert to the wild-type, pathogenic form, particularly in people with weakened immune systems:
So, yes, FDA oversight is a good idea.