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Most New Drugs Are Me-Too Medications
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. So when drugmakers get a successful product, they need to protect it by modifying it in some way.
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. What we see here is
that the drug companies are protecting their brand franchise.
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.
Retail spending on prescription drugs doubled from $64.6 billion in 1995 to $132 billion in 2000.
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 point 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.
National Institute for Health Care Management (NIHCM) Foundation May 28, 2002
| DR. MERCOLA'S COMMENT: |
This report, although published recently, does not have the more current statistics which show $175 billion was spent on drugs in 2001, up from the $132 billion in 2000. This easily translates to $200 billion dollars for drugs in 2002.
It is a sad, but not totally unexpected tragedy, that the country's drug use is being extended to our children. Americans had more than 3 billion prescriptions filled last year.
On average that is one prescription, every single month, for each man woman and child in the US.
As the late Illinois Senator, Everett Dirksen was fond of saying when he was referring to the Defense Department budget, "a billion dollars here, a billion dollars there and before you know it, you are talking real money".
Well we are talking a lot more than a few billion dollars. How about something like a nearly 200 billion dollars for drugs spent last year.
The sad tragedy is that we are spending all of this money on disease management focused on drugs and our return on this investment is profoundly poor.
Clearly there is something seriously wrong here.
For further comment on this article please see Nick Regush's analysis.
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