Only 15 percent of new drugs approved in the last decade were novel chemicals that the Food and Drug Administration deemed a significant improvement over older drugs, a study says.
The vast majority instead were similar to existing medicines. Yet during the same time, consumer spending on prescription drugs more than doubled to $132 billion — and most of the increase was spent not on the most innovative drugs, but on the less important or copycats, says the study by the National Institute for Health Care Management.
The FDA and other groups have long cautioned that major pharmaceutical breakthroughs are rare. But the study to be released Wednesday — by an institute partly funded by managed care — is among the first to rank spending according to drugs' relative importance to health care.
The findings show patients must be smart consumers, said institute president Nancy Chockley. "We are all under the impression that 'new and improved' is always much better," yet that's not always true, she said.
But the study drew immediate fire from the drug industry.
It "appears to be little more than a political and financially motivated cheap shot masquerading as science in the public interest," said Richard Smith of the Pharmaceutical Research and Manufacturers of America.
The FDA ranks drugs according to different criteria, such as whether they contain a never-before-used chemical. In addition, FDA-dubbed "priority drugs" promise a significant health improvement over existing treatments. FDA deems "standard" drugs that don't promise a significant improvement — although having options is important, as patients unhelped by one drug may respond to another, and small differences between competitors can prove important to individuals.
The institute reviewed 1,035 drugs that FDA approved between 1989 and 2000, and found that only 153 were both FDA-designated priority drugs and made of novel chemicals — in other words, a highly innovative drug.
Many other drugs that won FDA approval were modified versions of an existing medicine, a trend that increased as the decade wore on: Between 1995 and 2000, the FDA approved 304 such drugs, compared with 168 in the previous six years.
New drugs are often more expensive than their older competitors. But when the study examined the $132 billion Americans spent on prescription drugs in 2000, it found $44 billion went for drugs approved since 1995 — and only one-third of the spending was for the most innovative medicines.
The industry's Smith attacked the study's premise that a "standard" drug isn't very important. He said up to half of depression patients try two or three antidepressants before finding the one that works for them, and that many patients would deem very important a new weekly version of a pill they must take daily.
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