The FDA and International Reciprocity

by on November 19, 2013 at 7:07 am in Current Affairs, Economics, Law, Medicine | Permalink

Bacterial meningitis causes swelling of the membranes covering the brain and spinal cord. In the United States the disease kills approximately 500 people a year, often within days of infection. Survivors can have permanent disabilities including paralysis and mental disabilities. Since March seven cases of the type B strain have been diagnosed at Princeton University, with one case just last week. A vaccine exists and is available in Europe and Australia but the FDA has not permitted the type B vaccine for use in the United States.

The Centers for Disease Control and Prevention, however, has lobbied the FDA and they have now received special and unusual permission to import the type B vaccine. Following the CDCs recommendation, Princeton University has agreed to  administer and pay for the vaccine for any student that wants it.

It’s good that the FDA has lifted the ban on the type B vaccine but why should Americans have to wait for the FDA? Americans living in Europe or Australia can be prescribed the vaccine so why not here? I believe that Americans should have the right to be prescribed any drug that has been approved in Europe, Australia, Canada, Japan or other developed nation.

Indeed, as Dan Klein and I wrote at FDAReview.org, international reciprocity of drug approvals is simple common sense:

If the United States and, say, Great Britain had drug-approval reciprocity, then drugs approved in Britain would gain immediate approval in the United States, and drugs approved in the United States would gain immediate approval in Great Britain. Some countries such as Australia and New Zealand already take into account U.S. approvals when making their own approval decisions. The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs—including most west European countries, Canada, Japan, and Australia. Such an arrangement would reduce delay and eliminate duplication and wasted resources. By relieving itself of having to review drugs already approved in partner countries, the FDA could review and investigate NDAs more quickly and thoroughly.

As has now become clear, international reciprocity is not just about choice it can also save lives.

1 critics November 19, 2013 at 7:21 am

Why is it that economists, fully aware of the FDA’s deadly behavior, do so little about it? My guess is that the public is much more open to logical argument than is commonly supposed.

2 Eric Johnson November 19, 2013 at 7:30 am

I guess the obvious counter position can be summed up in one word: Thalidomide.

3 NL7 November 19, 2013 at 8:42 am

Which was released in Germany, where the Type B vaccine is approved.

4 mofo. November 19, 2013 at 8:49 am

Thalidomide was also released in the United States, what is your point?

5 Eric Johnson November 19, 2013 at 9:01 am

Wrong. It never got out of clinical testing in the USA.

6 Dan Weber November 19, 2013 at 9:06 am

The FDA never approved it in the US, although thalidomide did make its way to the US market.

It’s the perfect example of seen-versus-unseen. There are probably lots of examples of benefits that unapproved drugs could provide but we don’t see them, while we do see the effects of the bad drugs that the FDA did not approve.

I favor looser FDA regulations, but if my side doesn’t even know the history of the #1 argument against it then we should just give up.

7 Eric Johnson November 19, 2013 at 9:18 am

Exactly right.

A perfect counter-counter example would be Beta Blockers which were in use in Europe for years before they were approved here for acute heart failure.

If they were approved earlier, they may have saved thousands of lives.

8 Z November 19, 2013 at 9:18 am

“if my side doesn’t even know the history of the #1 argument against it then we should just give up.”

I find myself making this point a lot lately.

9 mofo. November 19, 2013 at 9:21 am

Your kidding right? The argument of drug approval reciprocity really turns on weather thalidomide was approved for use in the US or just clinically tested here? *That’s* the big lesson of thalidomide?

10 J1 November 19, 2013 at 10:50 am

Thalidomide has been approved by the FDA for treatment of some skin diseases (http://www.cancer.gov/cancertopics/druginfo/fda-thalidomide) . It’s exceptionally dangerous in women who are pregnant, and in women and men who conceive a child (as are a lot of approved drugs), but useful and effective used properly against ailments it’s been approved for. The issue in the post is whether there is a net benefit to the sort of restrictions that initially blocked Thalidomide. There’s no question some harmful drugs will be approved using reciprocity; the question is whether that harm exceeds harm done by the current process. It probably doesn’t.

11 Z November 19, 2013 at 9:28 am

The more obvious counter to that is the long history of lying by government. When the government is faking basic economic statistics for fun and profit, I’m not sure I would bet my life on them being honest about billion dollar drug approvals.

http://nypost.com/2013/11/18/census-faked-2012-election-jobs-report/

12 dbp November 19, 2013 at 11:02 am

The FDA would have approved Thalidomide back then but before the process was complete there were already birth defects in Europe being detected.

How about this? Automatic approval for use in the USA, six months or a year after approval in other developed countries unless they pull it from the market?

13 albatross November 19, 2013 at 4:48 pm

Intuitively, it seems like you’d still want the ability for the FDA to reject something that was approved in those other countries. But that should be an explicit overt decision, rather than just inertia in not getting it approved in the US.

Also, even a process that approved it in the US (modulo some kind of explicit FDA veto) after, say, three years of approval in any of those markets would probably be fine.

One question comes to mind here, though. Beta blockers and Thalidomide are both pretty spectacular cases of drugs where early approval could have big positive/negative effects on the world. But I wonder about all the less obvious, less visible cases. My impression is that most drugs that get approved in first-world countries are a smallish improvement over what went before, or maybe are just a comparable equivalent for people who have trouble with the other drugs of its type on the market. It’s not obvious to me that this kind of faster approval would generally have a huge impact.

14 widmerpool November 20, 2013 at 5:32 am

Absolutely. It’s shocking that no changes have been made to procedures since then. Might be repeated any day now.

15 mike shupp November 19, 2013 at 7:42 am

Eric Johnson has it right, I guess you have to have lived through the 50’s and 60’s to understand.

16 critic November 19, 2013 at 7:57 am

I did and I don’t. Consult any competent analysis of the FDA to see that the term “deadly behavior” is right on target. And, of course, I have heard of Thalidomide.

17 mofo. November 19, 2013 at 8:40 am

That implies that somehow re-certifying Thalidomide through several different drug authorities would have somehow helped. You either test something on pregnant women or you dont. I dont see how reciprocity changes that.

18 Eric Johnson November 19, 2013 at 8:50 am

But it did help. Thalidomide was never approved in the US, as a consequence relatively few children were born in this country with birth defects linked to it’s use. The same is true with Switzerland.

19 Alex Tabarrok November 19, 2013 at 9:05 am

Amazing that even after 50 years Thalidomide still scares. The basic fact is that dangerous drugs will sometimes be approved. That is a fact. But you also have to look at the costs of not approving drugs. Drugs that are *not* permitted by the FDA also kill. There is an invisible graveyard filled with the bodies of people who would have lived if more new drugs had been available and sooner.

Moreover, in terms of reciprocity. Is there any reason to think that Europe is worse in this regard than the United States. No. The US has also approved many drugs that were later shown to be more dangerous than expected. Vioxx, for example. All reciprocity does is recognize that we can reduce the costs of approval by looking at what other developed countries decide.

20 Eric Johnson November 19, 2013 at 9:28 am

I don’t disagree with you.

However an honest discussion would acknowledge that there are costs and benefits to administering our own trials. I’m just pointing out an obvious benefit.

21 mofo. November 19, 2013 at 9:39 am

I dont see how this can be considered a benefit to administering your own trials. If checking for the potential to cause birth defects is important, then we should only establish reciprocity with those countries that check for the potential for birth defects.

22 prior_approval November 19, 2013 at 9:46 am

‘Drugs that are *not* permitted by the FDA also kill.’

They sure do – which is a major reason that the FDA exists. Somehow, I don’t think you meant exactly what you wrote, though.

‘There is an invisible graveyard filled with the bodies of people who would have lived if more new drugs had been available and sooner.’

Which is exactly the same size as the graveyard we will all end up in. This is what is so strange about the American perspective – those people could have lived longer, but they would not have lived forever. Death is a given.

‘Is there any reason to think that Europe is worse in this regard than the United States.’

Nope – but then, why are a certain set of American advocates so completely opposed to any use of the precautionary principle which now guides much health related European regulation if Europe is not worse?

‘All reciprocity does is recognize that we can reduce the costs of approval by looking at what other developed countries decide.’

Or reduce the cost of regulatory capture to just one country.

23 mofo. November 19, 2013 at 9:56 am

“‘There is an invisible graveyard filled with the bodies of people who would have lived if more new drugs had been available and sooner.’

Which is exactly the same size as the graveyard we will all end up in. This is what is so strange about the American perspective – those people could have lived longer, but they would not have lived forever. Death is a given.”

Then why even have medicine at all then? Fatalism is non-sense. If my daughter gets sick, i want her to get better. Im not going to just shrug and say “well she would have died eventually anyway”

24 mofo. November 19, 2013 at 9:16 am

Isnt the more logical answer to have Canada or Germany or whatever test for safety when pregnant, rather than insist that the whole approval process be repeated?

Europe isnt Somalia. They are interested in preventing medical tragedies the same as we are, there is no reason to believe that if we allowed drugs approved in the UK, or France or Switzerland to be approved here that there would be some uncontrollable surge in birth defects.

25 chuck martel November 19, 2013 at 10:25 am

Europe isnt Somalia.

The Somalis don’t care if their kids die, proven by the fact that they have yet to figure out how to finance a huge bureaucracy to oversee every aspect of their lives. They do have access to aspirin and antacid, however, and Viagara is available at some bazaars.

26 BenK November 19, 2013 at 10:41 am

You can admit the international trials to evidence when seeking approval in a country without accepting the analysis wholesale. This is done during harmonization.

There are many reasons why international trials may not be accepted, by the way, including ethics challenges (ie consenting), data formatting and provenance challenges,
and differences among the populations in each nation.

However, if the trial is accepted, then it lowers the cost of approval in the USA. This can be discussed with the FDA in advance of submission.

27 Noumenon November 19, 2013 at 8:27 am

For this to be at all persuasive you have to address whether you are just trying to eliminate the FDA by creating a race to the bottom where all drug approval is done in Luxembourg. That’s what it seems like to me.

28 NL7 November 19, 2013 at 8:46 am

The end of the drug war, a dominant libertarian position, implies a lack of any drug “approval” process. It will be strange if recreational uses are free but medical uses are still government restricted.

29 Alexei Sadeski November 19, 2013 at 9:29 am

Not strange for *some* medical drugs to be restricted – Milton Friedman himself said the government should help stem contagion. Antibiotics, for example, should always be government controlled as their overuse or improper use can ‘strengthen’ some bacteria lines.

30 mofo. November 19, 2013 at 8:46 am

Really? In order to convince someone that redundant effort is inefficient we have to dismantle your straw man? If I was in England right now and needed some treatment, i would not be worried that their drug approval system is somehow barbaric, would you?

This is why the OP says “The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs”, we define the ‘bottom’ as a country that is very similar to us in terms of what they do to insure drug safety.

31 Noumenon November 20, 2013 at 1:15 am

You’re not thinking about the fact that market actors respond to incentives. On the day we pass reciprocity, drugs approved in England will be perfectly safe and the “bottom” will be a country very similar to us on drug safety. Ten years after passing reciprocity, the “bottom” will be whichever country created the laxest regulatory requirement that still looks similar to real drug safety, and drugs approved in England will be no safer than the very cheapest standard the drug companies can achieve through lobbying.

Even if it is a straw man and I just don’t see it, it would be good if he tried to create a little trust instead of just assuming we’ll take his arguments as disinterested pure rationality that serves no agenda.

32 Erick November 20, 2013 at 8:15 am

It’s a straw men because your argument makes no sense. Why did Luxembourg suddenly decide they didn’t care about drug safety? You can’t just yell “race to the bottom” and act like you’ve made a logical argument.

33 Noumenon November 27, 2013 at 1:44 am

I thought race to the bottom was like, a law of economics. Most anti-union laws in the South, car factories move South. Lowest wages in China, factories go to China. Easiest corporate law in Delaware, all corporations go to Delaware. Luxembourg would want to be the next Delaware, wouldn’t it?

34 Marie November 19, 2013 at 9:02 am

Many Americans have an objection to the current rubella vaccine, which is administered with the measles and mumps vaccine in a combo shot.

Once you were able to at least get the measles and mumps shot separately, but now the company no longer produces that option.

In Japan there is a rubella vaccine that is acceptable for use to these folks (I’m one of them) and has been used for, I believe, 20 years. We cannot use it here.

The people who angrily scream about herd immunity at folks who don’t fully vaccinate might do well to turn their pitchforks, it would have a much bigger practical effect since it would actually mean more vaccinations, not just more bluster.

35 Dan Weber November 19, 2013 at 9:08 am

I haven’t paid attention in a few years. What’s the current batshit crazy theory about the rubella vaccine?

36 Marie November 19, 2013 at 9:29 am

Not current, been this way from the beginning. Developed using cell lines some have objections to. Japanese one not. You’d think even a wildly pro-choice public would demand the Japanese version be available just to take out that segment, or at least insist the measles and mumps vaccines be available separately since measles is the current comeback disease.

It also happens to be listed in the package insert as a potential trigger for Type 1 diabetes, but I wouldn’t refrain from vaccinating with an approved rubella for that reason, since it’s a pretty tenuous potential connection. But I wouldn’t consider someone else in my situation to be overly batshit crazy.

37 Marie November 19, 2013 at 9:30 am

Sorry, my situation being kids with high genetic potential for developing Type 1.

38 dearieme November 19, 2013 at 10:05 am

One of the three-vaccine combinations that children are given was unsuitable for my daughter because of an event in my medical history. The NHS just gave her a suitable two-vaccine combo instead.

39 Dan Weber November 19, 2013 at 9:39 am

Oh, it’s the “rubella vaccine contains abortions” line. Gotcha.

40 Marie November 19, 2013 at 10:30 am

No, doesn’t contain abortions, or even aborted cells. Thanks for the super educated discourse, but none of that is my point.

I’ll translate for you — there’s a lot of bsc people out there that make decisions differently than you rational, moral people do, so if it’s important to you for everyone to vaccinate then why not give them a bsc-proof product they can use and you can get the vaccination rate up? What do you care how bsc I am, as long as I do what you want me to do? Is the rise in vaccination rate simply not enough to counter the costs of changes to the available products?

It’s right in line with this post — there are FDA policies that have reduced the real vaccination rate and increased the real infection rate in this country. The policies go against the public health goals they say they are shooting for. Shouldn’t the disconnect be addressed in some manner?

41 Adrian Ratnapala November 19, 2013 at 10:54 am

Thanks’ Marie for the new Three Letter Acronym. I myself went to university to get a degree in BSc.

42 Finch November 19, 2013 at 5:16 pm

> there’s a lot of bsc people out there that make decisions differently than you rational, moral people do, so if
> it’s important to you for everyone to vaccinate then why not give them a bsc-proof product they can use and
> you can get the vaccination rate up?

There’s a higher level risk that pandering to crazy people endorses the crazy people’s theories. Think about the possibility of government mandating GMO food labels, for example. I’d think that would be in play here, at least in principle. I could imagine some people being really mad about your proposed exception, arguing that the government would be suggesting that something that isn’t immoral is.

I’m generally in favor of looser medical regulation, fwiw.

43 Alexei Sadeski November 19, 2013 at 9:31 am

lol =)

44 Dan Weber November 19, 2013 at 9:14 am

Americans living in Europe or Australia can be prescribed the vaccine so why not here?

I generally support looser regulations, but the logic problems with this sentence are astounding.

45 prior_approval November 19, 2013 at 10:28 am

What is even more amusing is that in Germany, no one is forced to have a vaccination. There is no requirement in terms of public schools, for example.

Which means that if the U.S. were to follow German ‘best practices,’ vaccination would be at a lower level than it currently is, leading to a measurable higher level of deaths, even when dealing with something releatively harmless, that is not called ‘German measles’ in Germany (a disease that results in up to 20% spontaneuos abortions, by the way).

46 mofo. November 19, 2013 at 11:28 am

I generally try and make an effort to think about what you say, even if i disagree, but I have no idea what you are on about here?

47 DouglasC November 19, 2013 at 9:16 am

“… but why should Americans have to wait for the FDA ? ”

Because of the defining difference between rulers and the ruled.

Your government of politicians and bureaucrats impose endless “laws” (rules, regulations, prohibitions, mandates) marked by irrationality & unpredictability — what is right and wrong today may not be so tomorrow.

Your basic objection should not be upon a tiny FDA rule or the FDA itself, but upon the larger government system that generates such nonsense and denial of basic human rights.

48 john personna November 19, 2013 at 9:44 am

Wouldn’t the rational argument have a numeric argument about net lives saved (recognizing some possible deaths) from international drug reciprocity?

There might be some biases here, with a strong “first do no harm” bias in the medical community, and a public fearing “unnecessary death,” but I don’t think one story of one drug and one set of positive benefits tells the whole story.

Somehow you have to show the net of good drugs and bad drugs received under reciprocity.

49 prior_approval November 19, 2013 at 10:22 am

‘…but I don’t think one story of one drug and one set of positive benefits tells the whole story.’

Shhh – there is a narrative being created.

50 JWatts November 19, 2013 at 2:23 pm

Pot meet kettle. Kettle meet pot.

51 albatross November 19, 2013 at 4:58 pm

Also, you can’t assume the world will hold still for this change. Drug companies will change their behavior–whether that’s finding the loosest jurisdiction for all drug approvals, or each big drug company cozying up to one of the network of cross-approving governments. I don’t know that this would be a big problem, or any problem at all–it might still make the world a better place. But it at least deserves some thought.

52 BenK November 19, 2013 at 10:38 am

We have a serious problem with this and several other regulatory processes at the moment. However, it isn’t always clear how to reply.

Copyright, patents, FDA regulation of drugs, FDA regulation of foods, USDA regulation of foods all have some similarities. We should probably
separate them into regulation of ownership (copyright, patents) and regulation of safety.

Within regulation of ownership, different factions in the US (Disney, the MPAA, the RIAA vs Technology companies vs the artists vs the consumers) have orthogonal needs and values.
Some have regulatory capture and these impact the treaties written with other nations. (http://www.slate.com/blogs/future_tense/2013/11/18/tpp_wikileaks_white_house_claims_to_support_cellphone_unlocking_but_treaty.html)
(http://recordingindustryvspeople.blogspot.com/)
The complexity of the multiple interest groups makes it very difficult to percieve the shifting alliances; technology companies and content industries both claim to favor either
the artist or the consumer or both at any point in time, but it can be difficult to ascertain when those claims are accurate. In the international sphere, there is also the nationality
of the consumer vs the industry to consider.

It may seem that safety regulations are simple: industry, people, regulators. However, the parties really can be just as complicated, and who controls the regulators in each nation fluctuates.
Food colors are illegal in many cases in Britain, but legal in the USA, for example. This is based on safety and science. The margins of safety are not uniform and the science is not always
consistent. Non-linear toxicology is still percolating, vaccines are a regulatory challenge, and so on. Harmonization is only simple if the science is uniform and the regulations consistent;
the nationality of particular companies and the distribution of disease is also worth considering. A vaccine’s relative safety is dependant on the risk of the disease – so a more risky malaria
vaccine should be allowed in a malarial country, but not Sweden.

I hope that some of this complexity speaks against the simple narratives that otherwise hold sway.

53 mofo. November 19, 2013 at 11:32 am

I dont think anyone is arguing that there arent complexities here, but if you are arguing that science is somehow different in England, then im going to go ahead and disagree. Acceptable margins of risk might differ between societies, but if the science differs then it really isnt science.

54 Axa November 19, 2013 at 10:48 am

In general FDA does a good job protecting 90+% of people from quackery (% open to discussion), and there´s lesser percentage for whom present regulations are not optimal. Examples are those people that could live more if new drugs were approved sooner. Issue here is that today 100% of liability is on the drug manufacturer and the doctors that make prescriptions. What if a % of liability could be in the patient? What if an individual could sign a contract with the FDA telling basically “thanks for the regulation, but I’m dying here, let me try some new stuff, I am an informed and consenting adult, I acknowledge XXX Inc. manufactures it but it’s not liable in the USA , ETC”. After all, that’s exactly what happens when people moribund go for alternative medicine.

55 john personna November 19, 2013 at 11:06 am

A big red label, “NOT APPROVED IN THE USA” on every bottle would provide differentiation. Then one presumes the doctor and patient would have a conversation.

Of course, with real “reciprocity” Alex is seeking parity in implied testing and safety … something we should not really allow, unless we know there is parity in “peer countries.”

56 Beliavsky November 19, 2013 at 10:54 am

I think individuals should be allowed to buy drugs approved in other countries with their own money, but I am wary of creating a situation where private insurers, Medicare, and Medicaid are REQUIRED to pay for such drugs.

57 Li Zhi November 19, 2013 at 11:08 am

This discussion seems to be going on at an extreme level of abstraction. “If has approved a drug then the USA should.”
Leaving aside the arguments [sic] by those who do not think that drug regulation is part of a government’s primary reason for existence, (protection and security), we still need to consider 1. Differences in population size 2. Differences in population genetics 3. Differences in medical practice (commonly accepted ‘standards of care’). 4. Differences in statistical analysis 5. Differences in experimental design/clinical trials 6. Differences in standards for conflicts of interest 7. Differences in liability. So far in the conversation, no one has mentioned directly what I feel is one (two) of most important considerations: Monitoring/reporting of adverse events and how efficiently and rapidly withdrawal or limiting approval occurs when appropriate. Two other points: making the system more flexible will result in giving the bureaucratic regulator more arbitrary power and make regulatory approval that much less certain. Neither one of these is a good thing for business. And. Some of the arguments here appear to rest on the assumption of non-exceptionalism. “Since I can make rational health care decisions, everyone can (or should)” is a silly argument, imho. Three words: herbal dietary “supplements”.

58 Li Zhi November 19, 2013 at 11:11 am

The site edited out my braces: ” If country X has approved a drug, then the USA should.”

59 Cecil November 19, 2013 at 11:44 am

“I think individuals should be allowed to buy drugs approved in other countries with their own money, but I am wary of creating a situation where private insurers, Medicare, and Medicaid are REQUIRED to pay for such drugs. ”

For two out of the three in that list you’re wrong. I pay the premiums they provide the benefit. It’s not really any different than me paying directly. Part d is a direct add-on benefit now offered. It’s much the same as if I get a policy that covers in part elective plastic surgery… It’s then not the call of the insurance company if I think my nose is too big and want it smaller so it no longer gets in other’s business…. 😀

60 John Schilling November 19, 2013 at 12:21 pm
61 John Schilling November 19, 2013 at 1:30 pm

Stupid missing close-href tag. Stupid non-editable comments. Sorry about that; my bad.

62 Bill November 19, 2013 at 12:48 pm

I think college credits should freely transfer between any academic institution.

If credits were good enough for country x, they should be good enough here.

63 Seb November 19, 2013 at 1:34 pm

Bill, degrees are transferable. A person with a PhD from any German university is a candidate for any job requiring a PhD in the United States.

64 Adrian Ratnapala November 19, 2013 at 4:11 pm

Unless you want to work for the government.

At Imperial College London, one of my junior colleagues was an American who had just completed his PhD. I think also did his undergrad in London. He could not get a job at Sandia because Imperial was not recognised as a real university by whatever bureaucratic process was relevant to him.

65 albatross November 19, 2013 at 5:01 pm

This looks like nonsense to me. I know several foreign-born and US-born scientists whose PhDs are from outside the US, and who work for the US federal government.

66 Bill November 19, 2013 at 7:19 pm

Seb,

The comment was about transferable credits and you responded as if it were about advanced degrees.

The point is that educational institutions accept or reject credits based on the institutions that issue the credit. It is not automatic.

As for advanced degrees, you may have a point, although I am sure that Gertrude Stein would say a PhD is a PhD is a Phd, but not necessarily others.

67 Kent Lyon November 19, 2013 at 4:51 pm

Thalidomide is perhaps the only case in which the FDA looked good, and that was serendipitous. The “common sense” of reciprocity will not be implemented primarily because it is common sense. Remeber, the FDA is a law enforcement body, not a scientific body, although it masquerades as a scientific body. And it’s actions are generally damaging to the health and lives of individuals, and usually hamstring life-saving medical advances. Anything the FDA touches is stifled.
Take a couple of examples of FDA perfidy: Metformin was not approved for use in the US although it was available around the world for 50 years with safe usage. Metformin is an analog of a plant extract used by medieval apothecaries and is very safe. On the other hand, the FDA did approve and analog, Phenformin, which is toxic and can cause death from lactic acidosis. The more than 20 fold difference in toxicity of Phenformin vs Metformin is entirely predictable from it’s chemical structure and mode of toxicity (poisoning oxidative phosphorylation in mitochondria). Yet the FDA got it completely wrong. It approved the toxic drug and blocked the safe and effective drug. Metformin, finally approved in 1995 (it had been available since the 50’s or earlier), quickly became the first line drug for type 2 diabetes treatment, and is the only drug that has been shown to reduce all cause mortality in type 2 diabetes in any trial. Now it has been shown to slow, or halt, the progression of prostate cancer, perhaps other cancers, and is being looked at as adjunctive treatment for cancer.
Milton Friedman was quite correct. The principle result of FDA actions is to keep life-saving medications out of the hands of patients.

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