Burned by the FDA

by on May 29, 2013 at 7:22 am in Economics, Medicine, Sports | Permalink

woman with bad sunburn - isolatedIf you lived in Great Britain or Germany and your physician prescribed a pharmaceutical, would you ask them, “has this pharmaceutical been approved by the U.S. FDA?” Probably not. At FDAReview.org Dan Klein and I argue that international reciprocity is a no-brainer:

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.

Unfortunately, even when they can, the US FDA does not take advantage of international knowledge as the WSJ notes in European Sunscreen Roadblock on U.S. Beaches:

Eight sunscreen ingredient applications have been pending before the U.S. Food and Drug Administration for years—some for up to a decade—for products available in many overseas countries. The applications were filed through the federal TEA process (time and extent application), which allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe.

…Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a member of the American Academy of Dermatology, says multiple UVA filters still awaiting clearance in the U.S. have been used effectively outside the country for years.

“The U.S. is an island by itself on this one,” he said. “They’re available in Canada, available in Europe, available in Asia, available in Mexico, and available in South America.”

The sunscreens available in the U.S. are not without risk and in some ways, as the WSJ discusses, the European standards are stricter than the US standards so there really is no reason why sunscreens available in Europe and Canada should not also be available in the United States.

Hat tip: Kurt Busboom.

Addendum: 27 states have driver’s license reciprocity with Germany. Why not pharmaceutical reciprocity? With hat tip to whatsthat in the comments.

Jan May 29, 2013 at 7:26 am

Thalidomide.

Andrew' May 29, 2013 at 8:12 am

Not so much. Thalidomide is more of an example of public health than regulation.

“Although thalidomide was never approved for sale in the United States at the time, millions of tablets had been distributed to physicians during a clinical testing program.”

We found out of the problems of Thalidomide not because the FDA did extensive animal testing but because they and other countries did extensive human testing. Also, do you know for certain that the wait-and-see of the US FDA in this case isn’t just selection bias? As in, you slow walk everything and eventually there will be a success. Thalidomide is that success whereas Vioxx is one of the failures.

What Alex is talking about is if the one country actually does a legitimate approval process there is no legitimate reason (except maybe for differential genetics, which would be a small issue that is barely considered anyway) why that work wouldn’t translate. I doubt he’s talking about our FDA piggybacking on the Brits simply for CYA purposes.

Peter Schaeffer May 29, 2013 at 8:36 am

@jan, @Andrew’

The Wikipedia page on Thalidomide shows that it was approved in several countries before the FDA considered and rejected it

Andrew' May 29, 2013 at 9:12 am

Where does it say ‘rejected,’ EXACTLY?

From what I gather, the manufacturer withdrew its request after all the approved and unapproved problems. The US benefitted from a regulator who requested more data until the other human trials and fetus effects that were not thought possible until after Thalidomide proved they were possible were made apparent by doctor feedback.

The “success” of Thalidomide regulation is largely failure, just-so story, historical revisionism AND a little bit of an ad hoc regulatory scheme relying on a single regulator to have a backbone.

Andrew' May 29, 2013 at 9:20 am

In fact, in its most cynical interpretation, Thalidomide is an example of a successful system. We denied approval after other countries denied ultimate approval following their (accidental and disastrous) human trials. Economists might call this “no free lunch” and a system that relies on a “you first” and “then we’ll wait and see” is not exactly a system when everyone makes the first-mover problem a policy. But what I suppose Alex is proposing is that the drug companies push the ball to the goal line and then we determine if the other team’s goal-line defense is up to snuff, not just approving drugs based on the other team letting them walk it in to the end zone.

Thalidomide is NOT an example that you can prove safety a priori. I don’t understand why people think it is. It is a very clear example that you can demonstrate non-safety…by testing on people and keeping good records and providing feedback. But, that’s not exactly what we want either.

Andrew' May 29, 2013 at 9:30 am

https://en.wikipedia.org/wiki/Teratology#Teratogenesis

“However, after the thalidomide disaster of the 1960s, it became apparent and more accepted that the developing embryo could be highly vulnerable to certain environmental agents that have negligible or non-toxic effects to adult individuals.”

People barely even believed that teratogens existed. So, it is a little sketchy and just-soish that the FDA had this on the tip of their tongue (or the individual regulator who was stalling approval) did. What happened was we stalled, mostly by luck, and then the European results trickled in, luckily. Just imagine what formalizing the system that ‘succeeded’ for Thalidomide (which is now approved for many indications, by the way, after a long period of third-rail status) would look like. You would not implement that system. So, when people claim Thalidomide as some kind of success of a system that never existed (it wasn’t a system, it was a lady and some doctors in England and Europe) and would be disastrous if formalized, I have no idea what they mean.

Peter Schaeffer May 29, 2013 at 11:15 am

@Andrew’

“Where does it say ‘rejected,’ EXACTLY? ”

From “History of Thalidomide”

“In the United Kingdom the drug was licensed in 1958 and, of the babies born with defects, 466 survived. The drug was withdrawn in 1961 but it was not until 1968, after a long campaign by The Sunday Times newspaper, that a compensation settlement for the UK victims was reached with Distillers Company Limited. In Germany approximately 2,500 thalidomide babies were born.”

“The canadian Tragedy”

“Thalidomide became available in “sample tablet form” in Canada in late 1959. It was licensed for prescription use on April 1, 1961.”

“Teratogen Update: Thalidomide: A Review, With a Focus on Ocular Findings and New Potential Uses”

“Thalidomide (a-[N-phthalmido]-glutarimide) was synthesized in 1954, in what was then West Germany, by Chemie Gru¨ nenthal under the brand name of Contergan and was subsequently licensed in 46 other countries
worldwide, covering all continents”

Bottom line. Thalidomide was approved all over the world. Reciprocity would have brought it to the US.

Andrew' May 29, 2013 at 11:19 am

I think you are wrong about that for all the reasons I exhaustively discussed.

Like I said, we aren’t going to approve just because someone else approved, but because the entire approval paradigm is based on people using a drug that went through the correct approval process.

It is what you already do today…if you take any drugs.

Andrew May 29, 2013 at 11:27 am

It’s really weird. Did the 45 out of 46 countries approve the drug because of reciprocity? No, they just didn’t really do testing, especially for teratogens, partly because they never did prior to Thalidomide. We didn’t either by the way. What we most likely would have done if Thalidomide wasn’t so obviously teratogenic is to have stalled and slow-walked until nothing happened (or nothing was reported) and then slow walked our way to approval. Now we have a process and testing standards that other countries can be judged against.

dearieme May 29, 2013 at 9:54 am

“differential genetics”: no such thing – race is just a social construct.

Andrew' May 29, 2013 at 10:18 am

I agree with you. It makes us look extremely different and absolutely nothing else.

Go Kings, Go! May 29, 2013 at 12:07 pm

Andrew’: You are indisputably “extremely different” and I’ve never “looked” at you.

Andrew' May 29, 2013 at 12:46 pm

Yeah, I’m extremely different because I know about off-label prescription, know my doctor knows, and am not puzzled by my doctor not sending me home with a seatainer full of drugs.

Frederic Mari May 29, 2013 at 7:27 am

I am okay with the European authorities taking the FDA granting into account but would not consider it a proper substitute. In many cases, European regulation seems more demanding than the US one, even if sometimes ridiculously so (example: For a long while, maybe even today, RedBull drinks were forbidden in France).

Peter Schaeffer May 29, 2013 at 11:54 pm

@Frederic Mari, @Alex Tabarrok,

Here’s a simple sanity check. Can anyone name a single significant drug available in Europe or Japan that hasn’t been approved in the U.S.? If so, when was it approved? With what limitations? By which countries?

Preferably provide a list. Details are welcome.

dearieme May 29, 2013 at 7:31 am

“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.” Racism!!!!!!

ad nauseum May 29, 2013 at 3:22 pm

Classism!

Tom (Not that one) May 29, 2013 at 7:45 am

I think you provide evidence against reciprocity when you say:

“the European standards are stricter than the US standards”

If there were reciprocity then surely you’d have one regulator (the regulator for the least-regulated market) overwhelmed and other regulators taking a back seat? You’d also have products approved in markets for which the regulations state they shouldn’t be approved. In fact, it would be a disadvantage for a product to be approved in its domestic market, if that domestic market had higher testing standards than an overseas market.

Perhaps most importantly, there’s a political issue; by having a reciprocal arrangement, a country is in some way giving up some of its sovereignty.

What happens when a drug, approved in a foreign market, has an adverse effect that would have been picked up if the drug had undergone the domestic approval tests?

Rahul May 29, 2013 at 9:33 am

>>>“the European standards are stricter than the US standards” If there were reciprocity then surely you’d have one regulator (the regulator for the least-regulated market) overwhelmed and other regulators taking a back seat? <<<

If true, it seems great reason for the US-FDA to freeload off the Europeans. If they choose to relax their laws when faced with these overwhelming burdens (far fetched) it'd serve as a self-regulating load-balancing mechanism.

Jan May 29, 2013 at 10:20 am

And if you look at medical devices, the EU actually has much weaker standards.

Andrew' May 29, 2013 at 11:33 am

Then who is wrong?

Jani May 29, 2013 at 12:06 pm

Nobody has to be wrong. But as long as there are disparities in approval requirements, reciprocity will always be a race to the bottom.

Andrew' May 29, 2013 at 12:21 pm

Why do you think that?

anon May 29, 2013 at 7:53 am

Alex, nice job on this post, including the title, the sunburned lady, and the hat tip to Busboom. Excellent!

Have you been studying Drudge?

Finch May 29, 2013 at 9:27 am

Everyone should study Drudge. This isn’t so much an endorsement as it is an observation that there are things to learn from that guy.

Gyan May 29, 2013 at 8:17 am

What happens when a drug approved via reciprocity has its approval rescinded in the original regulatory zone?

Andrew' May 29, 2013 at 9:22 am

Thalidomide.

Rahul May 29, 2013 at 9:24 am

It loses it here too. Would that be bad?

Gyan May 29, 2013 at 9:32 am

So all the participants would have to have (nearly) uniform standards for approval and tolerance of adverse outcomes.

Rahul May 29, 2013 at 9:36 am

Which doesn’t seem like a bad assumption, on an average (for US / Canada / Japan etc.).

Assuming I am wrong, there’s still no reason for those nations with less stringent standards to free-ride off the regulatory mechanisms of the nations with more stringent standards.

Andrew' May 29, 2013 at 10:21 am

The entire approval paradigm rests upon the assumption that you can test a small number of people and extrapolate to a lot of other people.

Andrew' May 29, 2013 at 10:22 am

(which actually isn’t true, but it’s all we got)

Peter Schaeffer May 29, 2013 at 11:24 am

Gyan,

You are touching on a very serious point. ‘Approval’ simply doesn’t mean the same thing in every country and in all cases. The FDA (and its foreign counterparts) ‘approve’ drugs with a wide variety of associated rules, regulations, and limitations. It’s not a ‘approved’ vs. ‘not approved’ binary decision. To use an obvious case in point, Thalidomide has now been approved in many countries (including the US in 1998) for treating certain severe diseases (leprosy and others). You can be sure, that each ‘approval’ has been tied to very tight restrictions on how it can be prescribed, used, distributed, etc.

Tragically the reintroduction of Thalidomide has led to a new wave of birth defect cases. See “What’s happened to Thalidomide babies?” in the BBC News Magazine.

The point here is that foreign ‘approval’ doesn’t provide any definitive basis for automatic U.S. approval. The drug regulatory systems of the U.S and other countries are not identical and are not likely to be anytime soon.

Andrew' May 29, 2013 at 11:38 am

You mean the FDA-Approved use of Thalidomide for leprosy and other things? Is that what you refer to?

Peter Schaeffer May 29, 2013 at 2:37 pm

@Andrew’,

Yes, the FDA did approve Thalidomide for the treated of certain leprosy symptoms (and other conditions). See “Thalidomide (marketed as Thalomid) Information”. Quote

“Thalomid (thalidomide) is a prescription medicine taken, with the medicine dexamethasone, to treat people who have been newly diagnosed with multiple myeloma. Thalomid is also used to treat people when new lesions of leprosy flare up.”

Predictably, the regulatory scheme is already foundering. Quote from the same FDA page.

“Do Not Buy Thalomid (thalidomide) Over the Internet

You should not buy Thalomid (thalidomide) over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).

Thalomid has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.

To learn more about buying drugs safely, please see Buying Prescription Medicines Online: A Consumer Safety Guide.”

I was astounded to see Google search results offering me Thalidomide over the web. Not astounded enough it would seem.

Jason D May 29, 2013 at 8:20 am

I was thinking along the same lines for automotive crash testing — standardization of core tests (frontal, medium offset, side impact, rollover) that could reduce the cost / time associated with car safety testing.

Finch May 29, 2013 at 9:29 am

I had the impression that for cars the differences were deliberate. A sort of shadow protectionism.

Peter Schaeffer May 29, 2013 at 11:34 am

@Finch,

“I had the impression that for cars the differences were deliberate. A sort of shadow protectionism.”

That’s my impression as well. The truth is probably more complex. Some number of years ago I knew folks in the Germany car business well enough that they would tell me what they really believed (in private of course). They were convinced that American emission rules (stricter than Germany at the time) were a devise for keeping German cars out of the U.S.

Was it true? Did anyone in Detroit (or Washington) think that way? Not clear.

Closer to the present I have seen numerous accusations that car size rules (notably in S. Korea) were / are used to keep American cars out of the market. True? Not true? Partially true?

Bender Bending Rodriguez May 29, 2013 at 5:47 pm

I actually came in here to mention this and the JAA.

It would be _great_ if we had harmonization with Europe on vehicle safety/emissions. The American market would have access to all those great European econoboxes (e.g. Renault Twingo, Peugot 107, etc.)
Small, cheap cars with reasonable fuel economy. As an added benefit, we would create tens of thousands of jobs in the automotive repair sector. Bazinga!

Seriously though, European countries have mostly figured this out with the JAA. They have an entity that manages harmonization, but each country still has their own sovereign aviation authority.

If we followed the JAA model, the US and these other western countries could create a new body that helped to harmonize standards, documentation requirements, etc. but the result wouldn’t be
automatic approval in all countries following approval in one.

prior_approval May 29, 2013 at 8:22 am

‘If you lived in Great Britain or Germany and your physician prescribed a pharmaceutical, would you ask them, “has this pharmaceutical been approved by the U.S. FDA?”’

Sure I would – but then, I find the PDA and FDA information far superior to what is available in Germany at http://www.bfarm.de/DE/Home/home_node.html , though admittedly, one has to be careful when recognizing that drug companies care about profits, not patients.

‘At FDAReview.org Dan Klein and I argue that international reciprocity is a no-brainer’

Only if the U.S. also agrees to the German practice of granting pharmaceutical certification for only 5 years.

And whose fault was Vioxx again? Apart from Merck, obviously, and its targeted campaign against the critics of Vioxx. ( http://www.npr.org/templates/story/story.php?storyId=4696711 or http://www.naturalnews.com/019333_Cleveland_clinic_dr_topol.html )

After all, all those regulatory hurdles can be a real problem in terms of profits – as Merck well knows, which is why it worked so hard at deception and silencing its critics. It isn’t as if lives are at stake – well, the lives of those receiving the profits, that is.

dearieme May 29, 2013 at 9:57 am

“‘If you lived in Great Britain or Germany and your physician prescribed a pharmaceutical, would you ask them, “has this pharmaceutical been approved by the U.S. FDA?””

Probably I’d ask them whether it is a generic from Ranbaxy.

Peter Schaeffer May 29, 2013 at 11:50 am

@dearieme,

You aren’t taking your point nearly far enough. Alex Tabarrok is giving us the usual libertarian, pro-globalization hype about how we can benefit from outsourcing drug approval to other countries.

The real story is far more devastating one about failing globalization and how libertarian, Flat Earth fantasies have brought dangerous drugs in vast quantities. Quote

“REUTERS – Generic drugmaker Ranbaxy Laboratories Ltd(RANB.NS) pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice.”

“Ranbaxy USA pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements.

In the civil settlement, Ranbaxy has agreed to pay $350 million to resolve allegations that drugs from the two Indian plants did not meet specifications and that false claims were submitted to U.S. government healthcare programs between April 1, 2003 and September 16, 2010.

In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India.”

Of course, Ranbaxy isn’t real popular in India either.

“Ranbaxy to meet hospitals on drug ban”

“Ranbaxy is approaching some leading hospital chains for a goodwill meeting. The trouble stricken company has sought appointment with at least two major hospitals – Mumbai-based Jaslok and Gurgaon-based Medanta Medicity.

This comes in the wake of Jaslok recently issuing an advisory asking its doctors to avoid prescribing Ranbaxy manufactured medicines, while some others including Medanta reviewing the matter.”

We should be talking about how the dominant ‘free’ trade, Flat Earth, pro-globalization dominant ideology of our time has tainted America’s drug supply chain. Instead, some people would like to continue down the path that brought us to where we are now.

Per se, there is nothing wrong with the U.S. importing pharmaceuticals (or exporting them). However, each step in the foreign supply chain needs to be regulated as carefully as if the plants were in New Jersey. A sane country would have made such controls a prerequisite of drug imports. Because of the dominant globalization ideology, America is not a sane country.

Steve Sailer May 29, 2013 at 8:14 pm

Here’s Katherine Eban’s awesome article in Fortune on Ranbaxy Laboratories, “Dirty Medicine.”

http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

Doug M May 29, 2013 at 12:40 pm

The FDA and the Canadians have both recommended that Vioxx be returned to the market as the benefits to some patients outweighed the risks.

Faria May 29, 2013 at 8:23 am

It’s much easier for the drug companies to bribe/lobby/manipulate only one aproval process than several. Makes it cheaper for them, but also makes it riskier for society.

Andrew' May 29, 2013 at 8:36 am

That’s the problem? Bribery? Not the multiple billion dollar price tag on developing a new drug?

Okay, let’s do this. Let’s prove safety and then have the drug companies have to prove efficacy to every physician. That is if we just want to increase gross efforts.

Jan May 29, 2013 at 10:25 am

Doctors don’t have the time or ability to independently assess efficacy of every drug they might prescribe. They can, however, be manipulated by gifts and sleek marketing.

Andrew May 29, 2013 at 11:16 am

As your Thalidomide example shows, doctors are the only people who do this. It was doctors who exposed the problems of Thalidomide. Now, you can cordon off some of these doctors and call them a trial, but it is still doctors. And it is doctors who try the approved and unapproved treatments on their patients all the time to determine effectiveness.

So, now not only can patients not ever be allowed to make their own medical decisions but doctors can’t either?

Jan May 29, 2013 at 12:01 pm

Right, because I said doctors shouldn’t be allowed to do clinical research, report adverse events or treat their patients. Come on, man.

Andrew' May 29, 2013 at 12:22 pm

What did you say, then?

Andrew May 29, 2013 at 12:23 pm

I’m glad you say that what you said isn’t as stupefying as I thought it was. So, please clarify exactly what you meant.

Jan May 29, 2013 at 1:35 pm

I said patients and doctors should be allowed to make their own medical decisions, starting with a baseline that the available treatments should be proven to be safe and effective.

Rahul May 29, 2013 at 9:28 am

There’s some truth in what you say. Decentralized approval systems are more robust. Reminds me of Bruce Schneier’s arguments against singe-authority ID services.

But in this particular example (pharma approvals), I think, efficiency outweighs the risk.

LoganM May 29, 2013 at 8:32 am

Makes perfect economic, constitutional, and common sense for Federal bureaucrats to dictate what sunscreens citizens may use in the land-of-the-free.

There is no downside whatsoever to such minute exercise of arbitrary government power over all aspects of citizens’ lives (?)

Brandon May 29, 2013 at 11:41 am

Yes, it does make perfect sense for Federal bureaucrats who are deeply knowledgeable in the applicable fields to approve or disallow things that a lone individual really has no ability to assess the risk and efficacy of.

Mitch Berkson May 29, 2013 at 8:57 am

So what sunblock do I mail order from Canada? I’m lost without a Consumer Reports review.

Gyan May 29, 2013 at 9:49 am

What about the risk of approving drugs that may not work in the native population even if it does in a remote one, or vice versa?

dearieme May 29, 2013 at 9:58 am

What are you talking about? Race is just a social construct.

Rahul May 29, 2013 at 10:05 am

From that FDA website on “Collection of Race and Ethnicity Data in Clinical Trials”:

>>>For ethnicity, we recommend the following minimum choices be offered: Hispanic or Latino / Not Hispanic or Latino<<<

I was curious, is Hispanicity more important to a drug efficacy decision than African Americanness? Wonder why they chose this particular question as their minimum?

Peter Schaeffer May 29, 2013 at 12:11 pm

@dearieme, @Rahul,

Studies have shown some racial differentiation in how patients respond to drugs. See “Fighting Heart Disease, High Blood Pressure Among African Americans”. Quote

“Ferdinand was one of the investigators in the trial of a heart drug called BiDil, which was tested on nearly 1,150 African Americans. The study, published in 2004 in the New England Journal of Medicine, reported a 39 percent reduction in hospitalization and a 43 percent reduction in deaths compared with placebos, as well as an overall improvement in the quality of life.

The drug — a unique formulation of two older medicines — was approved by the Food and Drug Administration in 2005 with a label specifying it for use in African American patients, the first time it had done so”

In some other cases, racial differences are know to be quite significant but are handled differently. A few well known genes influence the likelihood and (worse) the aggressiveness of breast cancer in women. These genes are not uniformly distributed in the population. Black women have a higher incidence of these genes.

However, no one suggests race-based treatment in this case (to the best of my knowledge) because the genes can be directly tested for.

In general, that’s probably the future direction. Direct tests for specific genes that influence disease and how patients respond to drugs, rather than using racial proxies. In this realm, Lewontin is the correct model.

Rahul May 30, 2013 at 5:30 am

Yes, but my question was why is the FDA only requiring Hispanic ethnicity as its baseline reporting condition?

Peter Schaeffer May 30, 2013 at 11:33 am

@Rahul,

Not a clue on my part.

Bill May 29, 2013 at 10:06 am

International reciprocity is a no brainer.

Yeah, no brain alright.

We had some clients who would do clinical trials abroad, particularly in Europe during the 80s and early 90s. The type of review, along with the ways you could align yourself with physicians, make me very skeptical of reciprocity. In some of these countries, it is one thing to approve, and another thing to sell the product because the government is the purchaser, which means that approval is easier because no one uses the product. This creates a conflict–because their citizens may not be using the product. Moreover, because of, and not despite of, higher FDA standards, it is easier to market FDA devices and products abroad. Why is that? Because some countries and practioners are skeptical of the thoroughness of their own review.

Jan May 29, 2013 at 10:27 am

Also, Medicare basically pays for anything that FDA approves. Other countries usually have national health systems that require some value proposition to pay for a new product, like evidence of improved outcomes compared to products already on the market. We usually just pay for it.

Andrew' May 29, 2013 at 11:17 am

“Also, Medicare basically pays for anything that FDA approves.”

So, fix that.

jan May 29, 2013 at 12:05 pm

You want to “fix it” by letting FDA approve anything. That puts Medicare in the position of not knowing whether it even works when it comes on the market. Showing that something works is a logical baseline threshold for approval.

Now, requiring more comparative effectiveness research, that would help. Of course, the same people that say Medicare is socialist and will bankrupt us all are the same ones who will say “no, no, no” to demanding evidence. So we’re in a bit of a bind, aren’t we?

Andrew' May 29, 2013 at 12:24 pm

“letting FDA approve anything.”

Why is it either or with you guys? Seriously. Maybe the FDA approving Vioxx is why it killed so many people in the same way that the government’s implicit backing of financial agencies end up making bailouts inevitable.

Andrew' May 29, 2013 at 12:33 pm

And the people who want what they think is comparative research don’t seem to get that it is done by doctors and they also want medicare to pay for anything and everything but only what is approved (how does something get approved again?) while it is going bankrupt and bankrupting the entire government. So yeah, we are in a bind.

It literally took me zero time to find a problem with that logic because I found an example of it in real life. The UK will not cover a superior type of tonsillectomy because it can’t be done enough to show that it is superior and it is superior in a way that costs a bit more because it requires a one-time fixed costs but cuts the recovery time in half. In the US, people like me provide information to the system by trying it and regular doctors do it and ultimately we have progress. You can claim, and even believe, that your centralized version will work, but I point to my UK example of why I don’t believe it.

Jan May 29, 2013 at 1:51 pm

The tonsillectomy you refer to is not banned and nobody is preventing the believers from studying it to demonstrate the value of the method. If I recall, the UK actually has a pretty significant private health insurance and provider network that a lot of expats use. Are those guys doing tonsillectomy 2.0?

But your example gets back to my first point. The government should be supporting comparative effectiveness research. I think there is probably more to be gained from studying other types of interventions, but maybe your tonsillectomy procedure should be on the list, too. If we actually had a substantial CER program, we could study it, but we don’t. Of course in this country we are doing anything we can to defund and undermine CER.

How is your doctor’s independent tonsillectomy CER study going? What p-value is he using as his cutoff? Will he publish the results somewhere good?

Andrew' May 29, 2013 at 3:41 pm

People of a certain political persuasion always say “our system that we want to be single-payer (e.g. public education) will pay for and dictate care, but you are ‘free’ to use what isn’t covered.”

That is anti-economics I think.

Andrew' May 29, 2013 at 3:43 pm

“How is your doctor’s independent tonsillectomy CER study going? What p-value is he using as his cutoff? Will he publish the results somewhere good?”

As a matter of fact, it has been studied extensively and proven superior, not that everything has to be studied or can be. In fact, it used to be the standard of care. It is simply the partial tonsillectomy. It makes perfect sense and is superior in nearly every way, except a slight cost difference which gets amplified into being completely quashed by the incentives of single-payer.

MG May 29, 2013 at 10:07 am

This is an interesting question, which raises many. Are we talking reciprocity vis-a-vis “safety” determinations — which I think is basically what Phase I of the FDA approval maze is about? Or is reciprocity supposed to also reflect determinations on “efficacy”, etc, which is what Phase II and III are about? The first one appears to be a no brainer. The second one may be very desirable, but I can see that there could be different determinations based on how “efficacy” is valued and who pays for “inefficacy”.

whatsthat May 29, 2013 at 11:35 am

They do it with driving licenses.

Which, roughly speaking, carries the same costs and benefits as drugs. I could be wrong.

charlie May 29, 2013 at 12:26 pm

I’m sure it has nothing to do with hundreds of thousands of Americans who lived in Germany for occupation purposes.

BRD May 29, 2013 at 7:36 pm

Mhmm, because there is no difference between cisplatin and a driver’s license.

Chuck Currie May 29, 2013 at 11:51 am

Sunscreen, like air-bags and helmets, only encourages risky behavior and a false sense of security.

Cheers

prior_approval May 29, 2013 at 12:53 pm

Obviously, if you ride a motorcycle, you should become familiar with this research –

‘The most detailed level of investigation is the multidisciplinary, on-scene, in-depth investigation (OSIDI) such as the 1981 study of 900 motorcycle crashes entitled, Motorcycle Accident Cause Factors and Identification of Countermeasures (Hurt Report). This study was sponsored by the U.S. Department of Transportation, National Highway Traffic Safety Administration (DOT-NHTSA), and conducted in Los Angeles by Harry Hurt of the University of Southern California (USC). The Hurt Report has been used both nationally and internationally as the best source of detailed motorcycle crash data in the development of training, countermeasures, and related questions.’ http://www.nhtsa.gov/people/injury/pedbimot/motorcycle/00-nht-212-motorcycle/research9-11.html

A study that led to this summarized result – ‘The study also provided data clearly showing that helmets significantly reduce deaths and brain injuries without any increased risk of accident involvement or neck injury.’ http://en.wikipedia.org/wiki/Hurt_Report

You can download it here – http://commons.wikimedia.org/wiki/File:MOTORCYCLE_ACCIDENT_CAUSE_FACTORS_AND_IDENTIFICATION_OF_COUNTERMEASURES_VOLUME_I-_TECHNICAL_REPORT.pdf

Or, to use an old Bell Helmet ad tag – ‘If you have a 10 dollar head, buy a 10 dollar helmet.’

bxg May 29, 2013 at 3:29 pm

> Or, to use an old Bell Helmet ad tag – ‘If you have a 10 dollar head, buy a 10 dollar helmet.’

I’ve never got this, or similar advertising. “We are appealing to people with the reasoning power of a three-year-old, so buy our product!”. For most of us, isn’t this a negative?
I’ll treat you like a moron, so buy our product??? Doesn’t work with me. Does it work in general? Does a motorcyclist ever fall for this, and if so what is wrong with them?

Peter Schaeffer May 30, 2013 at 12:07 am

@prior_approval,

Of course, motorcycle helmets reduce fatalities in any given crash. A lot actually. The question is whether they lead to more risky behavior and whether the incremental risky behavior offsets the gains from helmets in any given crash.

I personally know two motorcyclists who crashed so hard they broke their (very high quality) helmets. Both crashes would have been instantly fatal without helmets. Sadly I crashed (at lower speed) without a helmet (a moron). I was lucky to make a full recovery. .

Winston Churchill supposedly commented on this once. His doctor told him to give up drinking, smoking, and overeating. He response was, “doctor that’s what I have you for”.

KLO May 29, 2013 at 12:38 pm

States have limited reciprocity for foreign visitors. No states allow their residents to rely on foreign residents and surely no states allow non-residents to obtain driver’s licenses for use in their home jurisdictions. The analogy is inapt.

prior_approval May 29, 2013 at 12:45 pm

And hey, that driver’s license reciprocity agreement even includes the idea of applying a limited time span to its validity –

‘An important warning: If you plan on getting a German license (with or without reciprocity), do so within three years of establishing residency in Germany. If you wait longer, you’ll have to start from scratch and take the same number of behind-the-wheel and theory lessons as a first-time applicant in order to obtain a German license. Reciprocity no longer applies in this case.’

So why don’t we agree to the German idea of reviewing pharmaceutical approval every 5 years? – after all, much the same idea applies when looking at American driver’s licences.

whatsthat May 29, 2013 at 1:01 pm

Okay, here is the info for Texas:

http://www.txdps.state.tx.us/DriverLicense/movingtotexas.htm

“Individuals who hold a valid, unexpired driver license from another U.S. state or U.S. territory, or from Canada, France, South Korea or Germany (the countries Texas has license reciprocity agreements with), do not have to take the knowledge or driving tests.”

All you have to do, if you have a license from Canada, France, South Korea or Germany, to obtain a Texas driving license is show up with documentation proving you are who you are and where you live, and you get it.

This is not perfect reciprocity, but it amounts to reducing the cost to obtain a driving license for Texas.

I am taking reciprocity here to mean “if it’s good enough for you it’s good enough for me”. The fact that from the four countries above, no driving or road knowledge tests are required, is a reflection of this interpretation.

To repeat: It is not to say that you don’t need a license, but only the cost reduces for countries where there exists a reciprocal agreement. Which is perhaps the relevant way to think about this.

Andrew' May 29, 2013 at 1:03 pm

That’s all well and good, but driving isn’t dangerous, and there is a lot of risk in moving away from our current system that keeps deaths from prescription drugs at nearly zero.

prior_approval May 29, 2013 at 1:30 pm

‘but driving isn’t dangerous’ – is that a typo?

Because otherwise, about 36,200 Americans in 2012 lost their ability to express their opinion about that statement –

‘After seven years of declines, traffic deaths in America rose again in 2012, according to a preliminary estimate by the National Safety Council.

An estimated 36,200 people were killed in traffic collisions last year — a five percent increase over 2011, according to the NSC. In 2011, 34,600 people were killed on American roads.’ http://dc.streetsblog.org/2013/02/21/nsc-36200-americans-killed-in-traffic-in-2012-first-increase-in-7-years/

Andrew' May 29, 2013 at 1:44 pm

Whew! That’s less than the number of deaths from FDA approved and prescribed drugs! See!

whatsthat May 30, 2013 at 12:24 am

Tell that to the guy who failed me thrice.

Ricardo May 29, 2013 at 1:03 pm

Photo is tasteless. I expect better from MR.

Peter Schaeffer May 29, 2013 at 1:25 pm

@Ricardo,

Apparently, learning from Drudge. See other comments on this point.

prior_approval May 29, 2013 at 1:36 pm

And Drudge has even said he is a libertarian, just like this site’s co-authors.

Andrew' May 29, 2013 at 1:45 pm

Wow. How have I missed this. The last time I visited The Drudge Report it looked like a basic HTML page.

Peter Schaeffer May 29, 2013 at 2:35 pm

@A,

Check out the picture of A.G. Holder. He does have his clothes on.

Andrew' May 29, 2013 at 1:25 pm

I licked it too.

prior_approval May 29, 2013 at 1:30 pm

I’m going to post the same question again – is that a typo?

Mark Thorson May 29, 2013 at 6:08 pm

Now I’m convinced. You’re an AI and not a very good one.

sort_of_knowledgable May 29, 2013 at 1:55 pm

What about reciprocity if European countries ban the use of certain pesticides or GMOs? It’s an automatic ban in the US?

Rahul May 29, 2013 at 2:24 pm

While we are discussing Pharma reciprocity what about medical license reciprocity? Can a British or Australian doctor move to the US and start practicing (without jumping through too many hoops)?

Shane M May 29, 2013 at 2:38 pm

My first thought on this is along the lines of Lawrence Lessig’s argument: “It’s easier to raise political money from drug companies if you more intimately control the approval process.”
http://www.amazon.com/Republic-Lost-Money-Corrupts-Congress/dp/0446576433

dead serious May 29, 2013 at 3:21 pm

“Addendum: 27 states have driver’s license reciprocity with Germany. Why not pharmaceutical reciprocity?”

Let’s just take this to its obvious conclusion and just share the same government and currency. What could possibly go wrong?

dead serious May 29, 2013 at 3:27 pm

Curious how a right-leaning Alex can possibly defend states’ rights with such an argument.

Matt May 29, 2013 at 4:05 pm

There is the issue that once licencing by the foreign food and drug regulatory authorities is taken as a substitute for the one in your country, your country will cut.

So far so good (‘cos we’re cutting redundant labor right), but….where does this process actually stop? Is it a “race to the bottom”? Who wants to have foreign nations “free riding” on the research and regs?

Now, if there were a financial element, wherein you could not use a foreign countries regulations without payment (a licence fee) then that would prevent this. That’s capitalism!

Dan K. May 29, 2013 at 4:31 pm

I agree with Ricardo: “Photo is tasteless. I expect better from MR.”

Seriously, this blog almost never publishes photos, so why this one? Oh wait…

Peter Schaeffer May 30, 2013 at 12:09 am

+1

Mark V Anderson May 30, 2013 at 8:34 pm

It got me to read it. Keep it up, Alex!

mulp May 29, 2013 at 5:21 pm

If stricter standards results in faster regulatory approval, why aren’t the drug companies lobbying Congress demanding laws that require tougher regulatory standards?

Or is the problem that big government liberal tax and spend which can impose tough regulations and speed the approval process is in conflict with low tax small government?

Isn’t Alex promising a free lunch – all the benefits of European socialism without paying the taxes?

Russ R. May 30, 2013 at 11:54 am

Why does sunscreen even require FDA approval?

Last I checked, sunscreen is neither a food nor a drug.

Comments on this entry are closed.

Previous post:

Next post: