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On May 17 The Wall Street Journal reported (in a front page article) that drug manufacturers’ financial clout, not a drug’s effectiveness, influences doctors’ prescribing choices. The Journal described a case involving steroids for sepsis which costs less than $50 vs. a new, highly promoted drug costing $7,000 a dose.
“The steroids saga illustrates one reason expensive brand-name drugs don’t face more competition from low-priced generics. There is little incentive for big pharmaceutical companies — the main financiers of drug research — to pay for studies of using steroids against sepsis, because the steroids’ patents have expired.” [See, Thomas M. Burton, “Drug Prices — Why They Keep Soaring” WSJ, May 17, 2002, front page]
ABC News reports (below) that although the public is spending $90 billion on prescription drugs—compared to $64 billion 6 years ago, “adding up all the drugs approved over the past six years, 80 percent of all those drugs were deemed by the FDA to be similar to what already exists. In other words, not a significant improvement.”
The rip off is made possible by a public policy that promotes collusion among drug industry stakeholders: doctors, research institutions, and government oversight agencies —among them the NIH, FDA, and OHRP. These government oversight agencies have become the handmaidens of the drug manufacturing industry instead of providing a system of independent checks and balances to ensure against abuse in clinical trial drug development and drug marketing.
As a result, clinical drug trials in recent years have not resulted in innovative new medicines that benefit the public—they have been manipulated by industry to increase short-term profit margins. ABC reports: “Surprisingly enough, the FDA says a new drug does not have to be any better than what already exists. All you have to be able to prove is that the drug is better than nothing.”
Industry-influenced government policies have bestowed extraordinary patent protection for the pharmaceutical industry. Its profits have increased by producing copy-cat drugs which are sold at exorbitant prices. False claims about new drugs mislead doctors and the public alike.
For other aspects of conflicts of interest in clinical research see: Fourteenth Annual (Military) Tri-Service Clinical Investigations Symposium May 6-8, 2002, San Antonio, TX. Presentation by Vera Hassner Sharav: http://www.wramc.amedd.army.mil/departments/dci/downloads/Tri-Srv-CI-May02/S harav%20Presentation.doc
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.researchprotection.org
Contact: Vera Hassner Sharav 212-595-8974 e-mail: veracare@rcn.com
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Consumers spent $90 billion more on prescription drugs last year than the $64 billion that was spent just six years ago. Are consumers getting their money’s worth from the pharmaceutical industry?
First there was aspirin to treat pain and inflammation, then came Advil, Aleve, and 40 other similar drugs. By 1999, Celebrex and Vioxx were on the scene, and they now outsell every other prescription pain reliever on the market. Every year, $4 billion is spent on Celebrex and Vioxx alone.
“There’s never been a study showing that they are more effective at relieving symptoms of joint pain and inflammation than all these other medicines that have been available for many, many years and are much more affordable,” said Dr. Matt Handley, a physician with Group Health Cooperative, a nonprofit managed-care organization in Seattle. On top of the $532 million spent every year on over-the-counter drugs, consumers spent $90 billion more on prescription drugs last year than the $64 billion that was spent just six years ago. And yet, there is little evidence that the huge increase in spending is dramatically improving the health of Americans. Are consumers getting their money’s worth? $802 Million for One New Medicine
Why do prescription drugs cost so much money? According to a Tufts University study, on average it costs $802 million to bring one new medicine to market. The high cost of drug development is the industry’s justification for the high price of drugs.
“The $802 million figure is used by pharmaceutical firms, I believe, to help explain the enormous challenge involved in bringing a new product to market,” said Ken Kaitin, who runs the Tufts Center for the Study of Drug Development. “These are extraordinary costs to bring individual products to market.”
While it is not possible to look at a breakdown of research costs ˜ companies aren’t required to make this information public ˜ their profits are public, and the drug industry is the most profitable industry in the country.
“Their R&D [research and development] costs could be $15 billion, $15 trillion, $15 gazillion, and it wouldn’t matter if their profits are double that,” said Dr. Marcia Angell, a former editor of the New England Journal of Medicine.
The drug industry claims its high profits are necessary in order to conduct expensive research and development. It spends more on research than any other industry. The federally funded National Institutes of Health may be the drug industry’s biggest benefactor. This government agency alone will spend more than $23 billion on research this year. And much of the research benefits the drug industry.
“There’s no other industry in which you have so much public investment in the fundamental knowledge that enables the development of the commercial industry itself,” said Dr. Bernadine Healy, who used to run the NIH.
And how important is this publicly funded research to the industry? The NIH looked at the five top-selling drugs of 1995 in a report. It found that “NIH-funded research played a critical role” in discovering each one of those drugs. But however much it may actually cost to develop a drug, which drugs are consumers getting for their money?
Similar to Existing Drugs
A closer look reveals that much of the profits from prescription sales are not derived from breakthrough drugs, but rather from drugs that are similar to already popular medications.
When a drug company submits a drug to the Food and Drug Administration for approval, the agency tries to determine how important the drug may be. And the FDA divides all drugs into two categories: “priority” drugs ˜ which are believed to be a “significant improvement” over what already exists, and “standard” drugs ˜ which are similar to what exists.
But, adding up all the drugs approved over the past six years, 80 percent of all those drugs were deemed by the FDA to be similar to what already exists. In other words, not a significant improvement.
“I think the level of innovation that we’re seeing from the pharmaceutical industry is really mixed,” said Nancy Chockley, who runs an institute funded by managed-care organizations. In a new report, NICHM found the percentage of new, innovative drugs coming from the pharmaceutical industry is actually decreasing. “What we found is that over the last 12 years that there’s really been a shift in the type of new drugs being approved by the FDA,” said Chockley. “And we found that most of the growth was really in drugs that did not show any significant clinical improvement.”
Extending the Patent Life
The patent system gives companies an exclusive monopoly for the length of the patent ˜ meaning they can make huge profits. That is the incentive drug companies have to continually invent new drugs. Then, when the patents on those drugs expire, other companies can copy the drug, make a generic version, and the new competition in the marketplace lowers the price. The FDA says the generic drugs are just as good as the original drugs. That’s the way the patent system is supposed to work, but that is not the way it always works. The drug industry’s lawyers and lobbyists have created or found so many loopholes in the laws that some generic drugs are often delayed or never get to market. BuSpar is an anti-anxiety drug manufactured by Bristol-Myers Squibb. After the company had had a monopoly on the drug for years, the patent on BuSpar was set to expire on Nov. 21, 2000, which meant a cheaper generic version was supposed to be approved by the FDA and available to consumers the next day.
And then, just hours before its patent on BuSpar expired, Bristol-Myers Squibb got a new patent on what the drug becomes after you swallow it. And the law is written in such a way that Bristol-Myers was able to then keep the generic drug off the market, claiming that it would violate its new patent. There was no innovation involved ˜ only an innovative legal strategy. Dr. Carol Ben-Maimon, who has worked in the drug industry for 15 years and is chairwoman of the Generic Pharmaceutical Association, believes that Bristol-Myers was in this for profit and not public health. “I don’t think there’s any question,” she said. “They didn’t do anything to the product to improve it. “
Bristol-Myers was sued by the generic companies, which claimed that the last-minute patent filed with the FDA should not keep the generic drug off the market. It took four months for a court to rule in the generic companies’ favor. “During those four months, Bristol-Myers continued to have the exclusive right to sell this product on the market, no generic competition, and I believe this product is about, over a $700 million-a-year revenue product for Bristol-Myers,” said Rob Funston, an attorney for a company that produced the generic version, Watson Labs. “So during those four months, they made approximately $200 million.” When asked several times to discuss its strategy to extend the patents on BuSpar and on other drugs, Bristol-Myers refused.
Less Innovation Many experts believe the industry, in general, is producing fewer innovative drugs. “If I’m a manufacturer and I can change one molecule and get another 20 years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac, instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less-certain endeavor, which is looking for brand-new drugs,” said Dr. Sharon Levine, the associate executive director and a pediatrician for the Kaiser Permanente Medical Group. She is responsible for assessing the best resources for the medical group, including helping decide which drugs are used.
But with so many drugs for each of these conditions, how are consumers supposed to know which drugs are the best? Surprisingly enough, the FDA says a new drug does not have to be any better than what already exists. “All you have to be able to prove is that the drug is better than nothing,” said Levine.
The rules by which this hugely profitable industry operates do not always serve customers adequately. The Federal Trade Commission is investigating whether drug makers illegally delay generic competition. Some members of Congress are trying to close the loopholes in the law to make it easier for generic drugs to become available. However, the drug industry has enormous influence in Washington. The pharmaceutical industry has more registered lobbyists than the number of senators and congressmen combined.
Copyright © 2002 ABC News
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