Miracle Malpractice

Medical technologies are a main driver for escalating drug costs, helping put health coverage out of reach for millions of Americans. In a new book, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises, two medical professionals explore disturbing practices and trends that lure consumers into thinking that "new" drugs and technologies are equivalent to or better than old ones.

The authors are professors at the University of Washington. Dr. Donald Patrick is a Ph.D. researcher in Health Services who has held appointments at Yale and St. Thomas' Medical School in London and has taught at the University of North Carolina. He is a member of the Institute of Medicine. Dr. Richard Deyo received the 2004 John M. Eisenberg Award for Career Achievement in Research from the Society of General Internal Medicine and is a fellow of the American College of Physicians. Dr. Deyo recently spoke to AlterNet about regulatory failures, marketing hype and the need for patient empowerment.

Kelly Hearn: You write that some people believe medical ethics, as currently structured, makes bad public policy. The argument is that huge financial outlays go to paying for medical technologies that, say, extend a single life by a week. Instead, those funds could be better spent improving needed social services or extending health insurance coverage. If Americans are to engage in this debate, what are the major considerations that need to be addressed?

Richard Deyo: I think the most fundamental thing is perhaps the hardest psychologically for people to make. We have to acknowledge that resources available for medical care are limited. They are not infinite. The problem is that individuals, physicians and patients all behave as if resources are infinite and cost is no obstacle. You hear doctors say cost shouldn't be an object. They say, "We have to do everything that might possibly benefit the patient."

The patients feel like there is no limit because insurance picks up the tab up to a million dollars, sometimes two. Now health insurance is becoming unaffordable to many people and Medicare is in trouble financially. I argue we should be trying to get the most health care for the most people as opposed to getting every last minute of life for an individual who may have a terminal illness. But words like "rationing" are taboo. We can't talk about it. It is almost as bad as being liberal in today's political debate. The truth is, if we reflect, we acknowledge that we'll have spent hundreds of thousands for one patient to prolong a week of life in an intensive care unit as opposed to spending that on other things like prenatal care and preventive services, on things that might save more lives.

Technology, you both point out, is only good to a point, that eventually it becomes a cost without a benefit. Given the American obsession with technological advances, what can be done?

More of us in the medical world need to be more honest about the limitations of technologies we are providing and realistic about what it provides. I think in many cases medical professionals, corporations and the media portray every new medical device as a breakthrough while failing to note that if a technology has benefits it is often tiny and often at the expense of side effects, complications and cost. We simply need to be more realistic about what technology offers. In many cases, if patients understood what the device does or doesn't do, they would make the kind of decisions doctors are not willing to make. They might say, "You want to prolong my life for a day for half a million dollars, that's not worth it."

You note in the book that information technology is helping in that respect by making doctors' charts and other patient information accessible and understandable to patients.

I think we need provide patients better information about what their choices are. In many cases, doctors are guilty of presenting a treatment as the only choice. In fact, there are a range of choices with benefits and costs associated with every one. If we could convey this in a concise and easy fashion, and engage patients, it would probably improve the quality of medical decisions. One way to do that is with information technology and computers. It's not the only way, but it is a good way.

States such as California and Arizona are having problems with "boutique hospitals," those that only provide costly, profitable procedures such as cardiac or imaging technologies. What dangers does this trend present mainstream general hospitals?

Boutique hospitals skim the cream of patients, those with good insurance coverage who are able to pay for services. They provide only the most lucrative services, such as high-tech cardiology and orthopedic services. The problem is that well-insured patients are pulled away from community hospitals that offer a full range of services and those hospitals may find it harder to stay in business. Emergency room care, burn care, psychiatric care – those are less profitable services that are at risk of disappearing.

Hype surrounding new medical technologies and products feeds on the American obsession with the next best thing. Yet many people assume the FDA works to filter through hype and false promises. But you cite a report showing that roughly half the experts who serve on FDA's 18 drug advisory committees had direct conflicts of interest in drugs and issues they were evaluating. This adds to a growing public perception that our regulatory mechanisms are polluted by industry money. How serious is this problem and what can be done to addresses shortcomings?

I think this is a pretty substantial problem. Since we wrote the book, we have seen the whole story of Vioxx and the advisory panel that recommended that Vioxx be allowed to stay on the market. That is a perfect example. In that case, something like 10 members had ties to the pharmaceutical industry. Absent their votes, the decision would have gone the other way. So I think there is good evidence that these kinds of ties do influence the advice panels give, advice which is usually taken.

The FDA should be more vigilant in trying to eliminate conflicts of interest on panels. They argue that these individuals have the best knowledge of drugs, and that often is true, but it seems those who have the knowledge and connections ought to be in a purely information providing and not a voting capacity. With some effort, you could assemble panels with fewer conflicts of interest.

It seems much of the hype is wrapped up in the problem of so-called "me-too drugs." Could you explain how this problem relates to rising prices for new drugs and technologies? Would it be helpful for example to require the FDA to test new drugs against other drugs on the market rather than against placebos?

This is terribly important. The problem with me-too drugs is a big one. Me-too drugs are chemically very similar to other drugs already available, yet they are typically marketed as if they were important new breakthroughs, and typically with very high prices. We found in many cases that new, expensive me-too drugs are not necessarily better than older generic and less expensive drugs. Because new and heavily marketed drugs seem like they must be better, manufacturers can command higher prices. That is an important driver of drug costs.

The story of calcium channel blockers for treating high blood pressure is an example. There are new drugs such as nifedipine and verapamil that cost 10 times more than old-fashioned diuretic drugs used for treatment. But the new drugs were never compared with older drugs. They were compared with placebos and indeed worked better. Two years ago, when they were compared to diuretics, the diuretics were equally good at lower cholesterol levels and more effective at preventing complications at one tenth of the cost. Yet we saw a proliferation of calcium channel blockers because they were being heavily marketed. That is a perfect example of why we need head-to-head comparisons.

Many consumers would like to the see the government clamp down on much of the costly hype being generated by Big Pharma, especially in advertising. But in the 2000 election cycle, as Hope or Hype points out, the drug industry spent $177 million on campaign contributions and $65 million on issue ads. The massive profitability of the drug industry and its willingness to throw so much money at lawmakers gives many people a sense that the drug industry is beyond control. Do you agree, and if so, are there any positive signs, any hints that despite its wealth and power, the drug industry can be reined in?

I agree the drug industry has enormous power and influence in politics. In the current administration that is reflected by lobbying and campaign contributions, but also by the fact that people within the administration have come from the drug industry. For example, a former pharmaceutical leader is head of Office of Management and Budget (OMB).

Is there any hope of bringing the industry under better control? I don't imagine it will be easy but it seems there is room for tighter regulation that would have some effect. In fact, profitability has fallen somewhat in the last two years in part because of negative publicity, in part because of a drying pipeline of new drugs and the fact that companies have overspent on marketing and underspent on genuinely innovative research.

Some changes that might help would be changes in the regulatory processes in the FDA, the possibility of head-to-head comparisons and of tighter regulation of advertising, for example. Drug companies are not required to get approval for television or print ads before they are aired. As the process works now, the FDA can file a complaint about misleading ads but only after ads are already on the air and only after a legal review that takes six weeks. That is often enough time to complete an ad cycle for a new drug. And what some drug companies do is simply replace one misleading ad with another misleading ad, which takes another six weeks for a letter to be generated. The advertising should be reviewed before it is aired, not weeks after. This would be slower and more cumbersome and not palatable to companies. But it would be a simple regulatory change.

We are the only country in world, by the way, other than New Zealand, that allows direct-to-consumer advertising. New Zealand is now considering a change to its law.

Much of the hype generated by companies and the media has to do with the glut of scientific studies that are often funded by industry. Corporations and many researchers say this is an inevitable consequence of modern science, of bringing the most experienced minds to bear on a development project. Other say the problem depends on how much of a researcher's income is from industry. How important is that calculus?

That is a very important calculus. Dangers arise when an academic physician doubles, for example, his or her income by getting research funds from industry. It seems a variety of other things could be done to help prevent current abuses. I would argue industry should be paying for research demonstrating efficacy. How to keep them honest is the question. One possibility is requiring they report all the results and register every project before and after the fact. It would be harder to hide things. It would be harder to stop a study in midstream when it looked like the results were not going to be favorable. It would also be harder to publish the same studies over and over again, which sometimes happen in current practice. Another important issue is that drug companies often analyze data and write the articles. If academics are going to do the research, they should analyze and write the results. Some journal editors are trying to enforce that rule with only modest success.

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