The majority of the new products the industry puts out, says Angell, are “me-too” drugs: ones that are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” Angell writes that around 75% of new drugs approved by the FDA are me-too drugs, such as more pills for heartburn or allergies that can be less effective than current drugs, as long as they’re more effective than a placebo.
Finally, Angell attacks major pharmaceutical companies for using “free market” rhetoric while opposing competition at all costs. She discusses Prisolec maker Astra-Zeneca, which filed multiple lawsuits against generic drug makers to prevent them from entering the market when the company’s exclusive marketing rights expired. The company “obtained a patent on the idea of combining Prilosec with antibiotics, then argued that a generic drug would infringe on that patent because doctors might prescribe it with an antibiotic.”
Angell’s goal is to reform the industry, whose top ten companies make more in profits than the other Fortune 500 companies combined. The doctor, a senior lecturer at Harvard Medical School, recently sat down with MotherJones.com to talk about how to “ensure that we have access to good drugs at reasonable prices and that the reality of this industry is finally brought into line with its rhetoric.”
MotherJones.com: Pharmaceutical companies say that the high price of drugs reflects the cost of R&D. What do you make of that argument?
Marcia Angell: These companies are justifying extremely high prices by saying they need this money to cover their high R&D costs, and that they’re very innovative, and that we should be wiling to spend it return for the innovation. In the book, I question both of those premises. I say that, yes, they spend a lot on R&D, but still they make more in profits than they spend on R&D, and they spend two to two-and-a-half times as much on what they call “marketing and administration.” If you want to argue that they need the high prices to cover R&D, it would make more sense to argue that they need the high prices to cover their marketing costs. I just want to put that in perspective. Also, their profits are enormously high. Until last year, [they were] the number one industry in the U.S. in terms of profits, and by a long shot. In 2002, the top 10 American [pharmaceutical] companies in the Fortune 500 made 17 percent of their sales in profits, whereas they spent only 14 percent on R&D. The median for the other Fortune 500 companies was between 3 and 4 percent of sales. So, you can’t make an argument that they’re just eking out a living, just managing to cover their R&D costs.
MJ.com: In your book, you say that even some of what the industry calls R&D is actually marketing. Can you elaborate on that?
MA: Well, no one knows for sure what goes into the R&D budget, because they’re not telling. It’s been estimated that about a quarter of it is spent on Phase IV clinical trials, many of which are just excuses to pay doctors to prescribe the drug. They don’t yield any real scientific information. But no one knows for sure.
MJ.com: So should the pharmaceutical industry be making its books public?
MA: Yes, because it’s an industry that is so dependent on the public for special favors. This industry, despite its free-market rhetoric, is on welfare big-time. It lives on taxpayer-funded research to a very great extent, and it lives on government-granted monopoly rights in the form of patents and FDA-conferred exclusivity. So, and industry that is so beholden to the public has some obligation in return. That includes opening their books. We ought to know more about their business. We ought to know whether the claims they make can really be justified.
MJ.com: Why should the industry have to open their books — or be asked to charge less for their products, for that matter — when other industries aren’t held to those standards?
MA: Well, the public is absolutely dependent on it for drugs that they need to take for their health and even their lives. So, I think there are some special obligations.
MJ.com: In the past you’ve written about prescription drugs that “there can be no better example of something that does not belong in the market,” but you don’t address that in the current book. Is this a position you still take?
MA: I don’t think I’ve ever said that they should come off the market, but there need to be reforms that accomplish several things. [Pharmaceutical companies] have too much influence over the education of physicians in this country. They have too much control over the evaluation of their own products, and that’s a conflict of interest. I think it needs to be regulated, but I’ve never suggested taking it out of the market altogether. It’s a funny mix of free enterprise and welfare. On the one hand, this industry is free to choose to make whatever drugs it wants to make. If it wants to make one more me-too drug, it’s free to do that instead of making an antibiotic that may really be needed. It’s free to charge whatever the market will bear in this county. And at the same time, it claims all sorts of special favors. It claims that Americans should not be allowed to purchase drugs in any other country. It claims the right to license taxpayer-funded research. It not only claims the right to very long patents, but extends them in all kinds of quite dubious ways. Now, this is hardly free enterprise.
MJ.com: In terms of licensing drugs from publicly-funded institutions, how much do companies generally pay? Is it relative to how much they charge?
MA: I don’t know. I know in the case of Taxol, it was very little. In general, when companies license a drug from universities, it’s not all that much compared with the profits. They’re licensing now from small biotechs as well. You had asked about innovation earlier, and the industry likes to portray itself as the engine of innovation, but in fact its major products are me-too drugs—minor variations of drugs already on the market. For example, we have six cholesterol-lowering statins on the market right now; we have five SSRI anti-depressants; we have seven ACE inhibitors to treat high blood pressure. If you look at the top-selling drugs on the market right now, most of them are me-too drugs, and the original of these drugs came on the market back in the ‘80s, or even earlier. The companies have been stringing out variations on the theme ever since. Also, the original drugs were usually based on government and university research.
MJ.com: Regarding me-too drugs, can’t one make the argument that there should be as many different variations of a drug as possible on the market? Shouldn’t the market decide?
MA: Well, we have an FDA because this isn’t something for the markets to decide. It’s a technical decision, and what it needs is evidence. The companies don’t provide that evidence. They don’t test their me-too drugs against other me-too drugs at comparable doses for the same conditions. The companies also make the case that there need to be several me-too drugs on the market because if one doesn’t work, maybe another one will. But until they test that, it’s an assertion. They don’t test their me-too drugs in people who have not done well with an earlier drug of the same class. They have to do that in order to prove that assertion. I suspect that in most cases, a second drug will not work any better, since me-too drugs are so similar, but no one can know until it’s tested.
MJ.com: Speaking of the FDA, you characterize the agency as one that facilitates new drugs, rather than regulating them. To what degree is the agency is controlled by the industry it’s supposed to regulate?
MA: Too much. The FDA now gets “user fees” from drug companies—about a half a million dollars for any drug that the FDA reviews. Those user fees are really small for the companies, but it’s a substantial part of the FDA budget. In fact, it’s probably more than half of [the budget for] the Center for Disease Evaluation and Research, which is responsible for approving new drugs.
MJ.com: So you would propose getting rid of those user fees?
MA: Absolutely. I think that the FDA should be funded by taxpayers, and it should see taxpayers and the “users.” It should not be funded by the industry it’s supposed to be regulating.
MJ.com: One of your book’s proposed changes is that the NIH be responsible for clinical research, rather than drug companies. But you propose that drug companies help pay the NIH to do this. Couldn’t this lead to a similar problem?
MA: No, because instead of paying user fee by drug, they would be levied a very small percentage of their revenues year-in, year-out. It wouldn’t be tied to research on any particular drug. This would be only for clinical trials, not the early development stage. Then, the NIH would put out contracts to universities and medical centers to actually do the clinical trials, but the NIH would have oversight.
MJ.com: FDA commissioner Lester Crawford recently warned against buying drugs from Canada, citing potential terrorist threat if drugs are tampered with. Do you feel this is an example of the FDA is reflecting industry interests, or is there a valid concern there?
MA: There’s no reason to think that drugs that are imported from Canada are any more likely to be unsafe than drugs that one gets right here. In fact, the cases of counterfeiting that I know of have all occurred in this country. So there’s some reason to think that maybe it’s safer to get your drugs from Canada [laughs]. The drugs that an American would purchase from Canada are going to be the drugs that they ordinarily pay much more for here—that is, FDA-approved drugs. They’re not going to be buying just something in a bottle; they’re going to be buying FDA-approved drugs that were shipped to Canada from European and American companies which have manufacturing plants all over the world. We have to remember that drugs are crossing borders all the time. Pfizer, for example, said on its website last year that it had 60 manufacturing plants in 32 countries. That right there constitutes a lot of borders. There’s nothing about the Canadian border that’s going to render these drugs poison. It’s a scare tactic, and what the industry does not want people to realize is the great price disparities between the United States and every other advanced country.
MJ.com: In the past, you’ve criticized the U.S. health care system, saying “if we had set out to design the worst system we could imagine, we couldn’t have imagined one as bad as this.” Do you still believe that, and does this book illustrate a larger concern of yours?
MA: The market-based pharmaceutical industry is one problem in the larger problem of a market-based health care system. We spent twice as much per person on health care as the average of all the other advanced countries, and that gap is growing. Yet, we get less for our money. We have over 40 million people with no insurance at all. Most of the rest of us are under-insured. The usual indices of health, like life expectance and infant mortality, are toward the bottom in the U.S. compared with other advanced countries. So, something’s wrong, and it’s the system. A market-based system distributes health care as a commodity according to the ability to pay, instead of as a social service distributed according to need. Yet, there’s an inverse relationship between one’s ability to pay for health care and one’s medical needs. The situation gets crazier when you allow competing, investor-owned insurance companies to insure Americans, because they have learned that the best way to compete is to keep costs down by skimping on health services. We have the only health care system on the world that’s based on dodging sick people. [Insurers] do everything they can to avoid covering people at high risk of getting ill, and when they do get ill, [companies] fight paying for it. They exclude certain expensive conditions as much as possible. They pass those costs back to the patient or another insurer. And that takes a lot of paperwork, and a lot of overhead.
MJ.com: In the book, you mention that every other developed nation regulates prescription drug prices— Well, they regulate prices, but they have different ways of doing it. If you look at Canada, it’s a very mild form of regulation, really. Drug companies make profits in Canada. They have a national board, and when a me-too drug comes on the market, they say it can’t be priced any higher than drugs already on the market. Nor can it be priced any higher than the median in seven advanced countries, and these countries include the U.S. Then they say the prices cannot rise any faster than the inflation rate. So, that’s not too onerous.
MJ.com: Is that an example of a system you’d like to see in the U.S.?
MA: Yes. Importing drugs from Canada is not a very sensible solution, because Canada can’t possibly supply the U.S., and the drug companies are now retaliating against Canada and squeezing their supplies. So, it’s not a long-term solution. It’s just a symptom of the problem of price-gouging in this country. We should be looking at the Canadian system, and maybe import that rather than importing the drugs.
MJ.com: Realistically, do you think a system of price control like that could ever happen in the U.S.?
MA: Well, something’s going to have to happen, because there’s no one around any longer who can afford the drug company prices. Not only are individuals having problems, but states are having problems. They feel these prices through the Medicaid system. The federal government is going to find that this fairly open-ended drug benefit is going to be completely outpaced by the rising prices.
MJ.com: If pharmaceutical manufacturers were forced to lower prices, couldn’t it backfire if they cut back on research as a result, rather than marketing?
MA: Well, they might choose to do that, but they wouldn’t have to. They could cut their marketing instead, they could cut into their profits. Their R&D very often comes from the NIH or other publicly sponsored research. This is true for the most innovative drugs, as well as for cancer and HIV/AIDS drugs.
MJ.com: You say that there’s “palpable” discontent among seniors and other about drug prices. Do you see this as having an effect on the problems you described in the book?
MA: I think that there are political effects, and I think that’s what you’re seeing right now with the importation from Canada. Congress has passed a law saying that you can import drugs from Canada, but that the administration must certify that it not add any risks. Both the Clinton and Bush administrations have refused to do that. It’s giving Congress an opportunity to play both sides of the street.
MJ.com: Given that Congress feels torn between seniors and the pharmaceutical lobby, do you think change will ever occur?
MA: I think that the public doesn’t seem to be buying the argument that drugs from Canada are dangerous. If it comes down to choosing between the money that the money that drug companies provide and the votes that citizens provide, I think members of Congress are going to go with votes. That’s what I hope will happen.
MJ.com: In the conclusion of the book, you stress that citizens should grill their doctors regarding drugs they’re prescribing. Why do you recommend that type of action most heavily?
MA: The other reforms will take time, but in the meantime, doctors are too willing to provide drugs for serious illnesses, but for very minor discontents. Those drugs are too often the very most expensive, heavily advertised, me-too drugs. I think that patients have to get a little savvier about that. Instead of just grabbing that sample and thinking they’ve gotten something for free, they ought to think about what it means. Nearly every drug has side effects. I do think that we are an overmedicated society.