videogamer
Banned
In many ways, Dr. Marcia Angell is an unlikely muckraker. A pathologist by training, she is the former editor in chief of The New England Journal of Medicine. She is also a senior lecturer at Harvard Medical School.
But just days short of her 65th birthday and her first Social Security check, Dr. Angell is taking on the American pharmaceutical industry with a new book, "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (Random House)."I don't worry about labels," Dr. Angell said in an interview at the Hotel Monaco, where she stopped during a book tour.
In a 1996 book, she noted, she argued "that there wasn't a shred of evidence that the breast implants were causing all the disease they were said to."
"I was said to be a tool of the pharmaceutical and device companies," Dr. Angell recalled. "I call them as I see them."
Q. Why produce an investigative book on the pharmaceutical industry?
A. Because everyone knows that prescription drug prices are sky-high. Americans pay far more for our drugs than people in other countries. The drug companies say, "We need high prices to cover our staggering research and development costs, and if you do anything to squeeze our prices, it will stifle innovation." The book was written to examine that argument.
Q. The pharmaceutical companies say their prices are steep because they spend somewhere in the neighborhood of a billion dollars per drug bringing them to market. Did your research support this assertion?
A. A group of economists - mainly funded by the drug companies - came up with the widely quoted figure on this. They said that it cost $802 million to bring a drug out. They, however, were looking at the most expensive drugs to develop: new chemical compounds developed entirely in house. Most new drugs aren't that at all. Most are what people call "me too" drugs, which are slight variations of older drugs already being sold.
According to these economists, the real cost of bringing out those rare original drugs is actually around $403 million. But they doubled it by factoring in how much money the companies might have earned if they'd invested that $403 million. Moreover, the economists did not figure into their total the many generous tax breaks these companies receive for doing research and development. This is a highly inflated figure.
The fact is that for the last two decades the drug companies have been hugely profitable. Last year there was a little wiggle downward, but in 2002, the 10 biggest American drug companies had a median profit of 17 percent of sales compared to a median of 3 percent for the other Fortune 500 companies. In the 1990's, profits ran between 19 and 25 percent. Prices are high to keep profits high.
Q. Exactly what are these "me too" drugs you argue against?
A. They are minor variations of old drugs already on the market. Sometimes a company creates a "me too" drug as a way of extending a patent on an older one. For example, AstraZeneca created Nexium to replace the virtually identical Prilosec when its patent was about to expire. By putting out these me-too's, the companies can get new exclusive marketing rights on what are essentially the same old drugs.
Other companies come in with their own me-too's because markets are expandable. It's been shown that when you advertise one me-too drug, you increase the sales of all of them.
Q. Why do you have a problem with this?
A. The prevalence of the me-too's really says an awful lot about the lack of innovation within the pharmaceutical industry. If you look at the new drugs marketed over the last six years, 78 percent weren't even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the F.D.A. as unlikely to be improvements over drugs already on pharmacy shelves.
At the same time, there are shortages of some important drugs that the pharmaceutical companies aren't much interested in making because they are not as profitable as the me-too's. But the companies don't have to turn out needed drugs, if they are not lucrative. And they don't.
Q. Was there anything in your life that pushed you to write this book?
A. As a journal editor, I witnessed a disturbing trend in pharmaceutical research. Twenty years ago, most drug trials were conducted at academic medical centers and the pharmaceutical companies tended to stand back during the testing period. However, in recent years, the companies have succeeded in attaching strings to research contracts, often designing the studies themselves, keeping the data in-house and deciding whether or not to publish the results. They also began to contract with private research companies for testing. Moreover, the medical schools and even individual researchers began to enter into entrepreneurial arrangements with the drug companies.
While all this was occurring, I began to see bias creep into medical research. And I saw a lot of it. The most obvious example were studies comparing a new drug to a placebo. That may be enough to get a drug F.D.A. approval, but it should not be enough for The New England Journal of Medicine. Doctors don't want to know whether a drug is better than nothing. They want to know if it's better than what they are already using.
Q. The first phase - the discount card phase - of the new Medicare drug benefit is about to go into effect. Do you, as a newly minted senior, believe it will make prescription drugs more affordable?
A. It's not going to have a major effect. These discounts are very small, maybe 10 to 15 percent. At the rate of inflation of drug prices, they'll be overtaken in a very short time.
Now, the main Medicare drug benefit that goes into effect in 2006 is designed to funnel billions of dollars to the pharmaceutical industry. It's an absolute bonanza for it. The pharmaceutical industry's lobbyists made certain that the legislation contained a provision barring Medicare from negotiating drug prices.
Interestingly, the federal government negotiates drug prices for the Veterans Affairs system and gets very low prices because it is a bulk purchaser. And Medicare would have been the biggest bulk purchaser of all - so it could have negotiated very low prices. That provision allows the drug companies to continue raising their prices faster than the inflation rate, and the drug benefit will soon become unaffordable.
Q: What can individuals do to fight back?
A: One recommendation is to be aware that this industry speaks through many voices, and whenever anyone makes a pronouncement about drug prices or anything else dealing with prescription drugs, people ought to ask themselves if there is a conflict of interest. Often there is.
Patients have to become much more skeptical about claims that drugs will cure whatever ails them. There's reason to believe that some new drugs are not nearly as good as they're claimed to be, that doctors believe the claims as much as their patients do, and we have to remember that almost any drug has a risk of side effects. This isn't to say that there aren't important drugs on the market. They can be very helpful and even lifesaving.
I'm not trying to say never take a drug -- but I'm saying that people should be reluctant to take drugs unless they're pretty sure that they're needed.
I'd like to add some other points not really covered in these quotes:
1. Drug companies benefit from NIH funding: not just direct funding, but also from the basic science research that the NIH funds elsewhere.
2. "Me-too" drugs: They can be drugs that are slightly changed so that the drug company can have a brand-name prescription drug. Another kind of "me-too" drug is one that uses the same general mechanism of action. Think of all the statins and SSRI's. It doesn't cost as much to develop these drugs individually because the general mechanisms have been elucidated and oftentimes the chemical structures of the drugs are similar.
IMHO, I'm more concerned with what Dr. Angell says is their argument: "We're [the drug comapanies] the source of your miracles, of your innovative drugs, and therefore don't mess with us." I'm not quite sure about large scale changes to the system, but Dr. Angell brings up good points against the claim that the drug companies need the high drug costs because of R&D.
http://www.businessweek.com/technology/content/aug2004/tc20040818_7567_PG2_tc121.htm
http://www.nytimes.com/2004/09/14/health/policy/14conv.html