There was a really interesting piece this week in the New York Times about a recent FDA decision to allow AstraZeneca to market its drug Crestor to a new class of people – those who are basically healthy. The story, I think, yields some insight into why our system is so costly and why it is not so easy to curb our spending.
As background, Crestor is one of the newest and most powerful statins, a class of drugs that had traditionally been used to treat high cholesterol. Side effects associated with statins are generally low. However, the risk of side effects increases with the strength of the drug, and Crestor is one of the most potent ones around. There have even been claims that the risk of side effects with Crestor is significantly higher than other statins.
Now, here’s the interesting part. How did the FDA come to approve this use of Crestor? The approval is based on the results of a study that showed Crestor led to a a significant reduction in heart attack and other risks from mostly healthy men over 50 or women over 60 with a risk factor such as high blood pressure. These people did not have high cholesterol, the condition for which Crestor was originally developed. The study was funded by AstraZeneca and conducted by the inventor of the CRP test, Dr. Paul Ridker of Harvard Medical School, both of whom stand to gain financially from the study’s results, AstraZeneca through increased sales of Crestor (which commands a high price due to its on-patent status) and Ridker through increased use of the CRP test, for which he receives royalties. Now, I won’t speculate as to the motivations of AstraZeneca, since it is a huge corporation not a person, but it seems like Dr. Ridker is a sincere believer in the power of the CRP test to more accurately predict heart attack risk, and so his motivations for promoting greater use of the CRP may be entirely altruistic.
So far, so good. This is the way the capitalist system is supposed to work. AstraZeneca created Crestor in order to make a profit. In order to increase its profit it went out and determined that Crestor could provide health benefits to a new class of people. If these people can be convinced to buy Crestor, AstraZeneca will make more profit and the people will reduce their heart attack risk. In an ordinary market, the mere fact that people were willing to buy Crestor for this purpose would be de facto proof that the benefits are worth the cost. Crestor is willing to offer the pills at a price, around $3.50 per day, and people are willing to buy at that price. So, they must value the benefit from the drug at least that much. End of story.
But, health markets are not ordinary markets, for at least four reasons. First, the government regulates the market, with the FDA endorsing the use of drugs for certain purposes. FDA approval is based on clinical effectiveness, not cost effectiveness. So, the mere fact that the FDA says that a drug can be used for a certain purpose does not mean that it is a cost effective measure. There may be other, cheaper ways of achieving the same results. FDA approval does not say anything about that. Second, drugs are often covered by insurance, and insurers often decide whether to cover some or all of the cost of a drug based on FDA approval. And, if a drug is covered by insurance, much of the cost of the drug is rolled into insurance premiums. So, the out-of-pocket cost of an individual who decides to buy a drug may be much lower than the total cost of the drug charged to the insurer. Third, decisions as to whether a patient should take a drug are made in cooperation with physicians. Often, the patient plays little role in deciding which medication to take. Physicians, on the other hand, are more concerned with health than cost, and they may recognize that the drug they are prescribing has a low cost to patients due to insurance. If the pill has a benefit and little cost to the patient, they why not prescribe it? Sure, it is costly to insurance companies, but many physicians have, at best, an adversarial relationship with insurers, anyway. I don’t think they would bat an eye at costing the insurer a few bucks in order to improve their patients’ health. Finally, health care decisions are incredibly complex. Information on the benefits of treatments is hard to come by, and cost-benefit information is even harder. Faced with FDA approval of a drug for a certain purpose and their physician’s advice that they should take it, many people will simply go along with the decision rather than try to overrule the experts.
All-in-all, these four factors on the “demand side” for drugs, and for health care more generally, point to why we tend to overuse them, at least from a cost-benefit perspective. Drug companies produce drugs and put them out there in an attempt to make a profit. There’s nothing wrong with that. However, due to diffusion of decision-making responsibility, lack of information and muted price signals, people are not doing the right price-benefit calculation on the demand side. The result is overuse.
In the case of Crestor, the Times article estimates that “500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. Stoke numbers were similar.” Treating those 500 people for one year would cost about $640,000 (at $3.50) per pill. Since these are usually-survivable heart attacks, that $640,000 might not even prevent any deaths.
Repeat this for every drug and every treatment, and that’s how you get to where we are today. So, how can we encourage people to make better decisions? As always, there answer here is not as clear. One way would be to ask people to pay more of the cost of drugs and other health care out of pocket. Faced with the full cost of their decisions, people will make better cost-benefit trade-offs. Of course, doing this will erode some of the benefit of insurance in reducing risk due to health care costs, which may be undesirable. (On the other hand, it can be argued that medication costs are predictable and, as such, are not really good subjects of insurance, anyway.)
While it is true in principle that increasing out-of-pocket costs can encourage people to make better decisions, the evidence here suggests that, due to the complexity of health decisions, this may not be the case in practice. For example, it has been shown that, faced with an increase in drug copayments, people tend to cut back on all drugs – both essential and non-essential ones – by the same amount. So, if we are going to ask people to do this sort of cost-benefit analysis, we’re going to have to give them better information about their choices.
Another suggestion has been to help educate doctors about cost-benefit tradeoffs. Today, most of the information about the effectiveness of drugs that doctors receive comes from the drug companies themselves. Of course, these companies have no interest in point out alternative treatments that are equally effective and less costly, and we shouldn’t expect them to. Education of this sort would likely help, but there is currently no such infrastructure, and it is unclear where such information would come from. The federal government has shown increasing interest in cost-effectiveness research in recent years, and the development and provision of this information (if it can be done in a fair, trustworthy way) might help. Of course, the fact that the government will be actively working to undercut a firm’s product might undesirably dull firms’ incentives to innovate, so the implementation here would be tricky.
Both of these suggestions point to a critical need that must be addressed if we are going to bring down spending on health care. Doctors and patients need better information on the benefit and cost of various treatments in order to make good decisions. Although it wouldn’t solve the entire problem, I think that it is a necessary condition for improvement. Some have argued that the right thing to do is for the government to make decisions regarding costs and benefits and directly regulate which treatments should be used in which cases. Such one-size-fits all solutions, however, overlook the wide variability in patients’ conditions and individual taste regarding treatment. Another approach would be for the government to invest in developing cost-effectiveness information and making that information available to physicians and patients in as useful a way as possible, allowing them to make better decisions. To my mind, the government providing information to markets to help them work better is a much better intervention than directly regulating particular modes of treatment.