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?


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.

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.


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.

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.

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.

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?

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.

But the French don't have a word for entrepreneur.

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?

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.

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.

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?

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.

Americans are more religious than the materialist Europeans. Believing in the supernatural makes you skeptical of materialist medicine, so we will demand a greater burden of proof that something is safe and effective than the more materialist-trusting Europeans.

Could be an evolutionary angle to this:


America is not more risk averse to medicine in general, but to drugs in particular. We are puritans. Europeans are communist hippies. We like to work. They like to have fun. I'm pretty sure these are stereotypes. Why the big surprise?

We are a more conservative culture, in the evil Republican sense of the word. Why do libertarians often sound like they just arrived here from Mars?

Actually, a good place to start in analyzing the slow pace of the FDA and other US bureaucracies is the Administrative Procedures Act. This piece of legislation subjects US bureaucracies to fairly strict judicial scrutiny of all regulatory actions, as well as extremely lengthy, time-consuming, and resource-consuming regulatory procedures. As an employee in one of these, I can tell you that many the cause of the slow pace of US regulatory change is the mere fact that agency employees are simply too overworked to undertake a lot of the easy rulemakings that could update the US system. Frequently, we are forced to look to Europe for the lead, not because they are less risk-prone than us, but because their legal regimes allow for nimbler, more creative regulatory action, where every line is not subject to second-guessing by outside parties.

Typically, defending ones current position using the tools with which they are clearly dominant is risk averse behavior. The US is #1 my many measures of power and is clearly #1 militarily. Choosing war can thus easily be perceive as a risk averse approach.

Why has the U.S. government been more risk averse with regard to medicine than European governments but less risk averse in other areas?

Don't you have it reversed. In the US, the individual suffers all the losses if a drug is bad while the drug company gains all the profits, unless you can find a lawyer who is willing to spend the millions require to sue the drug company. And the years.

Seldom does an individual win a case against the drug companies.

In Europe, the average person is protected from loss of income and never fears being denied future medical treatment for whatever reason, but epecially from medical error.

So, in the US, a drug reaction puts a huge risk of loss on the individual, while in Europe, society shares the risk with the individual.

Thus in the US, the individual is highly tolerant of risk, especially when it comes to a drug side effects, if one doesn't worry about all the things that can go wrong: loss of income, loss of wealth, loss of medical coverage.

Americans are also more risk averse about introducing new car/engine types, introducing alternative energy sources and in general everything that has big corporate interest vested in it. The reason is that there is too much money invested in the research of the existing drugs, too much money invested in fossil fuel-based economy and infrastructure to risk with new, more efficient technologies.
The reason is that for Americans the well being of the people (public utility) is less important than maximizing the profits.
Why invest in the electric car and risk a failure when you can continue to squeeze profits from the existing less efficient and polluting technology?

Simple. European governments cover health care costs, and don't have to worry about lawsuits. So, there is little incentive to regulate medicine too harshly ... as it may only increase costs. If someone winds up dying from a bad drug combo .. oh well, no more healthcare costs to cover at all.

"Besides, it is easy to say the the FDA's slow drug approval has killed more people than Europe's faster drug approval has."

Easy to say, and just as false.

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