Larry Sobal column: There's a mess beyond Vioxx
Last month, it was all over the news that a U.S. federal judge in Houston ruled that the latest trial involving Vioxx was a mistrial due to a hung jury.
To refresh your memory, Vioxx is a prescription painkiller manufactured by drug giant Merck. The drug was released in the market in 1999 after the Food and Drug Administration ruled it safe. After being dogged by safety concerns, Merck pulled the drug from the market in September 2004 after studies showed in doubled the risk of heart attacks and strokes in patients who took it for 18 months or longer.
The Houston trial is just one of 7,000 Vioxx lawsuits against Merck. So far, one jury has awarded $253 million to the family of an individual who died while taking Vioxx while another jury found no Merck wrongdoing in a similar case.
While this makes for good media fodder, the question I have — so should you — is whether the Vioxx situation is really a symptom of a diseased pharmaceutical industry in need of major reform.
There are huge dollars at stake in the world of drug development. Vioxx was a blockbuster drug that generated roughly $2.5 billion in annual sales and Americans are now spending in excess of $200 billion a year on prescription drugs. Drugs are the fastest-rising component of health care costs.
At first glance, it would appear that drug manufacturers are simply pursuing capitalistic incentives geared to turn out a steady stream of innovative medicines that lengthen life, enhance its quality and avert more expensive care. If successful, we reap the benefits of miracle drugs and they reap the benefits of handsome profits. However, once you get past this altruistic view, a closer inspection reveals major concerns.
My first concern is that the profitability of drug companies is the barometer by which all other industries are measured. In fact, for more than two decades, the drug industry has clearly been the most profitable in the U.S. In 2002 the combined profits for the 10 drug companies in the Fortune 500 ($35.9 billion) were greater than the cumulative profits for all other 490 companies put together ($33.7 billion).
My next concern is that drug industry is not a model of free enterprise, but one utterly dependent on government-granted monopolies (in the form of patents from the FDA) and is no longer focused on brining new miracle drugs to market. The reality is there are few new innovative drugs being brought to market. The vast majority of "new" drugs entering the market are variations on existing drugs. These "me-too" drugs are often just a molecular variation of an existing product and developed just before the patent expires.
There is a lot at stake related to patent approval. Once patent exclusivity expires, usually averaging around 14 years, generics flood the market and are often priced at less than 20 percent of the name brand and profits subsequently plummet.
Since the FDA controls the drug approval process, one would hope that this organization takes an unbiased stance and always acts in the best interests of the public. With around 3,000 lobbyists targeting Washington, no other industry spends more money with more people in order to sway public policy, and the FDA has made some questionable decisions to protest pharmaceuticals.
Among the changes I advocate are that the FDA should only provide patent protection to a drug if it is deemed to be "better" in some distinguishable way versus other drugs already on the market. In addition, the FDA needs to take back control of how drugs are tested by the manufacturers so that all clinical trials are fully disclosed. These are but a few of the changes needed to clean up the corporate drug scene.
To refresh your memory, Vioxx is a prescription painkiller manufactured by drug giant Merck. The drug was released in the market in 1999 after the Food and Drug Administration ruled it safe. After being dogged by safety concerns, Merck pulled the drug from the market in September 2004 after studies showed in doubled the risk of heart attacks and strokes in patients who took it for 18 months or longer.
The Houston trial is just one of 7,000 Vioxx lawsuits against Merck. So far, one jury has awarded $253 million to the family of an individual who died while taking Vioxx while another jury found no Merck wrongdoing in a similar case.
While this makes for good media fodder, the question I have — so should you — is whether the Vioxx situation is really a symptom of a diseased pharmaceutical industry in need of major reform.
There are huge dollars at stake in the world of drug development. Vioxx was a blockbuster drug that generated roughly $2.5 billion in annual sales and Americans are now spending in excess of $200 billion a year on prescription drugs. Drugs are the fastest-rising component of health care costs.
At first glance, it would appear that drug manufacturers are simply pursuing capitalistic incentives geared to turn out a steady stream of innovative medicines that lengthen life, enhance its quality and avert more expensive care. If successful, we reap the benefits of miracle drugs and they reap the benefits of handsome profits. However, once you get past this altruistic view, a closer inspection reveals major concerns.
My first concern is that the profitability of drug companies is the barometer by which all other industries are measured. In fact, for more than two decades, the drug industry has clearly been the most profitable in the U.S. In 2002 the combined profits for the 10 drug companies in the Fortune 500 ($35.9 billion) were greater than the cumulative profits for all other 490 companies put together ($33.7 billion).
My next concern is that drug industry is not a model of free enterprise, but one utterly dependent on government-granted monopolies (in the form of patents from the FDA) and is no longer focused on brining new miracle drugs to market. The reality is there are few new innovative drugs being brought to market. The vast majority of "new" drugs entering the market are variations on existing drugs. These "me-too" drugs are often just a molecular variation of an existing product and developed just before the patent expires.
There is a lot at stake related to patent approval. Once patent exclusivity expires, usually averaging around 14 years, generics flood the market and are often priced at less than 20 percent of the name brand and profits subsequently plummet.
Since the FDA controls the drug approval process, one would hope that this organization takes an unbiased stance and always acts in the best interests of the public. With around 3,000 lobbyists targeting Washington, no other industry spends more money with more people in order to sway public policy, and the FDA has made some questionable decisions to protest pharmaceuticals.
Among the changes I advocate are that the FDA should only provide patent protection to a drug if it is deemed to be "better" in some distinguishable way versus other drugs already on the market. In addition, the FDA needs to take back control of how drugs are tested by the manufacturers so that all clinical trials are fully disclosed. These are but a few of the changes needed to clean up the corporate drug scene.
posted by Chris Placitella at 6:20 AM
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