2002-05-29 10:00:25 -0400
By Karen Pallarito
Nearly two-thirds of prescription drugs approved in the 1990s were modified versions of existing drugs or products containing the same active ingredients as those already on the market, according to a new study by the National Institute for Health Care Management (NIHCM) Foundation.
Only 15% of new drug approvals were for medications that contain new active ingredients and provide significant improvement over existing drug therapies, the study found.
The findings strike at the heart of the pharmaceutical industry's claim that changes to Hatch-Waxman, the 1984 US patent protection law, would harm patients by stifling drug innovation. It is because of these protections, the foundation argues, that drug companies seek to extend their market exclusivity by introducing altered versions of older medications.
"It's very hard to come up with very innovative drugs," said Nancy Chockley, president of the NIHCM Foundation. So when drugmakers get a successful product, they need to protect it by modifying it in some way, she explained.
Intellectual property protections are intended to foster real innovation, "but what we've done is created a great deal of incentive to tweak the product," Chockley told Reuters Health. "What we see here is that the drug companies are protecting their...brand franchise, if you will."
Officials of the Pharmaceutical Research and Manufacturers of America (PhRMA), a lobby group that represents manufacturers of brand-name drugs, hadn't seen the full report by Tuesday afternoon. However, they vigorously defended the industry's record of innovation in a hastily organized teleconference with reporters.
Calling the report a "politically and financially motivated cheap shot," PhRMA Vice President of Policy and Research Richard I. Smith charged NIHCM with failing to consider the advantages of new drugs to individual patients and ignoring basic facts about drug research.
Furthermore, the report does not consider pharmaceutical advancements in the pipeline, Smith said. As a result, he said, its basic premise is "fundamentally flawed."
Smith accused NIHCM, an organization run by a board predominantly made of Blue Cross and Blue Shield representatives, of wrapping its own political agenda in the guise of an unbiased research report.
The NIHCM Foundation study is based on US Food and Drug Administration (FDA) statistics on new drug applications (NDAs) approved from 1989 to 2000. It incorporates the agency's own system of classifying those applications based on a drug's level of innovation.
Of the 1,035 drugs approved by the FDA over the 12-year period, only one-third (361) were new molecular entities, which treat diseases in novel ways, the investigators found. Less than half (153) of those were given "priority" status, which is reserved for drugs the agency believes could provide significant clinical improvement over existing medications. Of the 674 drugs that didn't contain a new chemical entity, only 91 were given priority status.
Among the highly innovative drugs that were approved were Pfizer Inc.'s Lipitor (atorvastatin) for high cholesterol and Viagra (sildenafil) for erectile dysfunction, as well as Merck & Co.'s Fosamax (alendronate sodium) for osteoporosis; and GlaxoSmithKline's Avandia (rosiglitazone) for type 2 diabetes.
But a total of 674 drugs, or 65% of FDA-approved medications, contained active ingredients that were already available in marketed products. Of these, 558 drugs differed from the marketed products in that they were combined with another active ingredient, offered in a different dosage form or delivered through a different route of administration.
A product traditionally available in oral form, for example, might have been reformulated to be delivered via a transdermal patch.
Noting that patients respond differently to medicines, PhRMA's Smith rebuffed the notion that slightly altered medications aren't innovations. As an example, he cited the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Research shows one-third to one-half of patients are not going to improve on the first SSRI they take, he said. But they may respond on the second or third drug.
"If you're a patient who failed on the first drug but got better on the second or the third drug, you're going to call that a cure," Smith said.
There's nothing wrong with drug companies making modified versions of older drugs, "except it drives up the cost" by cutting back use of generics, Chockley said.
Drug companies typically will introduce the newer version of the drug at a discounted price, which keeps generic drugmakers' share of the market down, she noted.
Retail spending on prescription drugs doubled from $64.6 billion in 1995 to $132 billion in 2000, the report indicates. Of the $67.4 billion increase, $44 billion is the result of increased spending on drugs approved between 1995 and 2000. Priority drugs with new chemical ingredients accounted for 33% of the increase in spending. "Standard-rated" drugs, which don't qualify for expedited FDA review, accounted for 67% of the increase.
New drugs of all types were priced much higher than the older drugs they replaced, the study notes. New priority-rated drugs commanded the highest prices. In 2000, the average price per prescription for the most innovative class of drugs was $91.20, versus an average price of $37.20 for older drugs, approved before 1995.
At $65.07 per prescription, incrementally modified drugs designated for standard review, while not as expensive as some other classes, still cost 75% more than older drugs in 2000, the researchers found. "This suggests that brand manufacturers can maintain relatively high prices for aging products by making incremental changes to them," the authors note.
The point, Chockley asserts, is that a lot more money is going into
prescription drugs, but it isn't producing many more innovative medicines.
Increased spending may help to support research and development, "but what
it also definitely does is support a lot of line extensions" to help preserve
blockbuster products, she said. "It's just a context we should all understand."
Copyright © 2002 Reuters Limited