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Why are Americans more risk averse about medicine than Europeans?
The stereotype is that Americans are more risk-loving and entrepreneurial than the less-rugged Europeans who instead seek shelter under the umbrella of the welfare state. Yet when I talk about the FDA I point out that for many decades (from say the late 1960s to PDUFA in 1993 and perhaps again more recently) the FDA lagged behind its European counterparts in approving new drugs. U.S. risk aversion in drug approvals is especially peculiar since the major scare which increased FDA powers and slowed down approvals was the thalidomide disaster but thalidomide was approved in Europe not in the U.S. Nevertheless, we were the ones who got scared.
More recently, Scott Gotlieb argues that the Europeans have pushed H1N1 vaccine production forward using adjuvants and novel production techniques while the US has chosen less risky (some might say less entrepreneurial) older approaches.
The tort system is sometimes blamed for excess U.S. risk aversion but in both these cases it's mostly the U.S. government which is more risk averse than its European counterpart. Moreover, the US government is more risk averse over medical matters and not say about sending troops abroad or about providing a safety net for other risks.
I think this is a puzzle. Why has the U.S. government been more risk averse with regard to medicine than European governments but less risk averse in other areas?
Posted by Alex Tabarrok on October 29, 2009 at 10:41 AM in Economics, Medicine | Permalink
Comments
Do you think it has anything to do with the established drug companies primarily being US firms? Caution in approving new drugs would likely reduce returns to established drug owners.
I've often wondered why biotechs always focus on US FDA approval first when it seems like Europe would provide some cash flow for them to reduce the risk that they'll run out of money before the FDA approves their drug.
Posted by: nelsonal at Oct 29, 2009 11:00:11 AM
Alex,
You answered your own question: thalidomide.
Did you ever see those photos in Life Magazine?
Talk about emotional scarring.
,dave
Posted by: Dave Barnes at Oct 29, 2009 11:11:34 AM
Just some thoughts:
(1) War is probably more popular with Americans than Europeans. Europeans suffered far more in the world wars, and have to worry about geopolitical precedents in ways that the U.S. doesn't. Hence the American government doesn't risk its political capital as much by going to war.
(2) I wonder if Europe has an equivalent to our quack miranda warning medicines? (i.e., the herbal supplements that promise to help with all kinds of things and say in the fine print they aren't intended to treat or cure anything). If not, maybe the dichotomy emphasises the government approval over standard drugs and thus give the FDA greater reputational risk.
http://scienceblogs.com/whitecoatunderground/2008/01/quack_miranda_warning.php
Posted by: Joe at Oct 29, 2009 11:23:34 AM
Off-topic but important: is it just me or the RSS feed has been dysfunctional for the past 24 hours or so?
Posted by: Guillaume at Oct 29, 2009 11:26:10 AM
You answered your own question: thalidomide. Did you ever see those photos in Life Magazine? Talk about emotional scarring.
Dave Barnes, did you even read his post? Why were the Americans more emotionally scarred by thalidomide than the Europeans who actually suffered through it? It's not surprising that thalidomide would cause a reaction, but Alex is asking why the reaction was so much worse in the US than in the places that actually experienced it.
Or are you arguing that thalidomide was much less worse than the photos made it out to be? I don't buy that either.
Posted by: John Thacker at Oct 29, 2009 11:26:10 AM
I would guess higher real incomes mean higher real values on lives, higher real spending on medicine, and higher real spending on safety for it. It is just one of those things to spend more on.
Posted by: Lord at Oct 29, 2009 11:37:20 AM
Geographical competition, perhaps? If France refuses to approve a drug that has been legal in Germany for years, lots of French people can easily cross the border to get the drug, and then return home to spread word of how much it has helped them. With several dozen countries, all it takes is for one approval and word of mouth leads to pressure for all other countries.
By contrast, in the U.S., we only have two neighboring countries, and not that many people live close enough to take advantage.
Posted by: Nathan at Oct 29, 2009 11:43:21 AM
Is it driven in part by a growing distrust in America of A) science/scientists and B) the government? If the FDA is blamed by the public for every dangerous drug that makes it to market (instead of the companies that didn't exercise due diligence in development) then wouldn't they be more risk-adverse?
Likewise, is this linked to a growing trend to trust folk-wisdom/medicine and conspiracy theories over hard facts and evidence? For example, Airborne using "developed by a teacher" as a marking tool, when that should be a sign it's practically useless beyond supplying a few vitamins.
"If you cram your face full of Acai berries like me, your late-stage brain cancer should disappear overnight!!!!! Chemo is for idiots!!!" -Idiot Celebrity #1938819
Posted by: a goddamn communist at Oct 29, 2009 11:44:03 AM
I wonder if it has to do with whether the legislature or the executive has more control in a given field. With war, it's predominantly executive, and we get fairly rapid decisions, with the FDA it's ,more legislative so the decisions tend to be safer, so as to appeal to the majority of individual states, which would seem to be more diverse than the more monocultural europeans.
Of course, it could also come down to a trust issue, with europeans believing their experts more than we do.
Of course, it is also possible that different groups of people have different perceptions of risk. We view food safety as a bigger risk apparently than say the french, who still eat rotted pheasant and such. I'd imagine we also differ on the relative safety of guns as well.
Posted by: Bellisaurius at Oct 29, 2009 11:47:37 AM
I believe that in Europe, alternative treatments to drugs, such as naturopathy, chiropractice, and homeopathy, are a lot more mainstream than they are in the U.S. Here, where prescription drugs are more often the only treatment considered, patients have more to lose by being harmed with new drugs. In Europe, there is probably a lower percent of patients on any particular drug, and the more risk-averse patients will seek alternative treatment.
Posted by: DNW at Oct 29, 2009 11:47:48 AM
Does it have anything to do with a growing trend of distrust in western medicine and willingness to listen to Retard Celebrity's folk-wisdom remedy of the month, and the media's insatiable desire to put on-air whichever idiot pseudo-expert resonates most strongly with their viewers?
Posted by: a goddamn communist at Oct 29, 2009 11:48:04 AM
Holy crap the comment system is freaking out for me. Ignore my repeated posts, if they show up.
Posted by: a goddamn communist at Oct 29, 2009 11:49:07 AM
Combo of history and corporate regulatory capture.
The stereotype about American independence is really wrong. 13% of people in France make their living from self owned business vs. 8% in the U.S. In other words over 50% more people in France own their own business as a percentage of the population.
Posted by: Mike S at Oct 29, 2009 11:50:52 AM
I vaguely remember reading some years ago that European countries often had more extensive systems for identifying and dealing with drug problems that emerged after drugs were initially approved and on the market. If this is true, European countries could accept more risk going in because problems would be stopped sooner and with more assurance if they developed.
Posted by: Martin at Oct 29, 2009 12:13:57 PM
But the French don't have a word for entrepreneur.
Posted by: Barbar at Oct 29, 2009 12:14:15 PM
You mean the thalidomide disasters. The original event, then the overreaction that has done even more damage.
"Hey, let's make a drug for pregnant women but not actually test it with pregnant women. Brilliant!"
"Oh snap! No drugs for anyone, certainly no clinical trials for pregnant women!"
Funny how we rarely follow up stupidity with brilliance.
GDC, no to answer your question. And the trend toward believing the worst rumors about government actions is that they are often true. I've been keeping a mental not of all the things I hear about in the "alternative" medical articles before I see them in the formal journals and such. Resveratrol, toxicity/autism, flu vaccine questions, etc.
Who actually listens to celebrities? The same people who are shocked to find that Baby Einstein doesn't make babies geniuses? Does idiocy actually have trends?
Posted by: Andrew at Oct 29, 2009 12:26:22 PM
Having represented one generic drug company and several device manufacturers, this is an old story. It is usually easier to conduct clinical trials in Europe, but the actual approval process proceeds based in FDA approval here, folowed by approvals then elsewhere because FDA approval is regarded by most countries as a gold standard. Clinicals are easier to conduct abroad partially due to tighter control of physician practice, greater lattitude given to academics, and university programs. The US is more thorough in its approval process, and you should be grateful for that (I know, you're going to get a bunch of blogs on type I and type II error), but a number of drugs are simply modest improvements over what is already on the market. When the utility of an improvement is low, how much risk do you want to have?
Posted by: Bill at Oct 29, 2009 12:27:11 PM
Maybe it has to do with the delivery system, which has kind of been touched upon. In most of these countries the government is the payer of healthcare services, so if they really don't want you to get a new drug they just won't pay for it, but maybe can authorize some doctors to do additional testing.
Here, we pay for our own healthcare, and the media is filled with stories of wealthier people suffering some affliction who are eager to pay any price for a drug that hasn't been approved (or even tested). I'm guessing in both countries the outcome is probably the same as far as the percentage who get the drugs. Since we don't regulate the coverage, we have to regulate the legality more.
Posted by: Chris at Oct 29, 2009 12:38:51 PM
Probably as matter of the EU being a true federation, and the US being far more centralized. The EU ostensibly has a bunch of mini FDA's that can approve drugs in their country of jurisdiction, as well as an organization that makes EU-wide approvals.
This allows for a wider variety of drugs to be approved. Add in open border policies, and you have a mechanism for the information of effectiveness or ineffectiveness to be transmitted very quickly. Of course, there are downsides to this as well. For one, there is a belief that the EU doesn't move quick enough to approve EU-wide. This might answer why companies focus more on getting their drugs approved in the US first (as they get access rights to much larger markets).
Of course there are other factors, like plain old policy rigidity.
Posted by: Ryan Vann at Oct 29, 2009 12:40:11 PM
European governments are usually more involved with paying for health care than the US government is. Prescription drugs usually replace more expensive treatments. Therefore approving drugs more quickly may save the government money. For the FDA there is no upside to approving drugs and a significant downside of bad publicity if the drug turns out to be harmful.
Posted by: sourcreamus at Oct 29, 2009 12:40:36 PM
I would guess higher real incomes mean higher real values on lives,
LOL. Unless they happen to be the lives of brown people outside the US, in which case they're valueless.
Besides, it is easy to say the the FDA's slow drug approval has killed more people than Europe's faster drug approval has.
Posted by: bartman at Oct 29, 2009 12:52:12 PM
would the differences in party discipline in the US vs Europe play a role.
In Europe the individual back bench MP does not play an important role in the political process so you do not have as irrational a political system as in the US where each MP is a much more independent player who has to keep doing or saying extreme things to call attention to themselves so as to get press play and publicity in their home district.
Posted by: spencer at Oct 29, 2009 1:33:20 PM
I've tried to figure out the facts behind this claim: "...the Europeans have pushed H1N1 vaccine production forward using adjuvants..." As far as I can tell, the Swiss based Novartis has been running a trial using a "fish oil" emulsion over the past three years testing its benefits with H5N1 (the Avian flu of a couple years ago) and the performance warranted a wider trial with H1N1 the first of September 2009. They are required to perform extensive tracking of side effects, and this type of adjuvant has been known of and used for decades, and known to have side effects.
Adjuvants are commonly used, most commonly aluminum compounds, but they are incompatible with many vaccines, and in most cases with influenza. The role of the adjuvants is to cause a localized reaction at the injection site which causes the immune system to respond more aggressively which helps contain the virus at the site, or in the case of the oil based adjuvants to keep it concentrated at the injection site in an emulsion. Or at least that's my understanding of adjuvants reading the web. As a foreign substance that is chosen to provoke a reaction, it clearly has side effects, so it comes down to balancing the cost-benefits.
Of course, if the goal is stretching the raw material of purified egg vaccine protein production, the best way is to use the nasal spray. While the injection of killed influenza virus protein is typically 15 microliters, the nasal spray requires only 1 microliter of attenuated live virus which is cultured in human nasal tissue to produce the exposure needed to obtain the immune response.
Apparently this ends up being targeted at children because adults don't think anything but an injection can work, this being their lifelong experience with vaccinations. That plus the added costs associated with new processing and training, the added tracking in the early expanded trials, and the added profit for the proprietary processes. The reduced production costs of the raw material is now offsetting the higher costs of the nasal delivery system, so nasal spray is now the preferred method for those who have sound immune systems.
And the use of injection adjuvants does not extend the raw material as far as the nasal spray, typically requiring 3-5 microliters, less than the typical 15, but more than the typical 1 in the nasal spray.
So, does anyone have actual specifics on what is really making the EU a "superior market" for H1N1 vaccines?
Posted by: mulp at Oct 29, 2009 1:45:25 PM
Does the FDA predate the corresponding European agencies?
Sometimes being the leader has its drawbacks, because others get to learn from your activity while it's hard for oneself to change due to tradition, uncertainty, etc.
Posted by: MPS at Oct 29, 2009 2:15:40 PM
Risk aversion? Don't be so quick to personify corporate entities, especially democratic governments. They don't necessarily have neatly ordered preferences, Arrow's theorem and all that.
Posted by: josh at Oct 29, 2009 3:25:42 PM
