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[e-drug] NYT: New medicines seldom contain anything new
- From: Kirsten Myhr <email@example.com>
- Date: Wed, 29 May 2002 09:26:37 -0400 (EDT)
E-drug: New medicines seldom contain anything new
[From todays' New York Times. Copied as fair use. KM]
May 29, 2002
New Medicines Seldom Contain Anything New, Study Finds
By MELODY PETERSEN
Two-thirds of the drugs approved from 1989 to 2000 were modified versions of
existing drugs or even identical to those already on the market, rather than
truly new medicines, according to a new study.
The report also said that most of the increased spending on new prescription
drugs was on products that the Food and Drug Administration had determined
did not provide significant benefits over those already on the market.
Some of the reformulated prescription drugs are now among the most heavily
advertised. For example, Nexium, a recently approved ulcer medication, is a
modification of Prilosec, which is soon expected to lose its patent
protection. Clarinex, an allergy drug, is a reformulation of Claritin.
Sarafem, for premenstrual irritability, is the same drug as Prozac but has
been renamed and repackaged in capsules of pink and lavender.
"The plain fact is that many new drugs are altered or slightly changed
versions of existing drugs, and they may or may not be all that much better
than what's already available," said Nancy Chockley, president of the
National Institute for Health Care Management Foundation, which wrote the
report. "Consumers should be more aware of that."
The institute receives 40 percent of its financing from the Blue Cross Blue
Shield health insurers and has often clashed with the pharmaceutical
industry because of its reports on the rising cost of prescription drugs.
The drug industry's trade group, the Pharmaceutical Research and
Manufacturers of America, criticized the study yesterday, saying that it was
"flawed and misguided."
Richard I. Smith, vice president for policy and research at the group, said
that even if a medicine was similar to one already on the market, it could
still offer many benefits to patients. For example, he said, even though
there are several similar drugs that fight depression ? including Prozac,
Paxil and Zoloft ? many patients may not respond to one medicine but will to
"If a new drug does not have sufficient advantages, it will not be used,"
Mr. Smith said.
He said the report by the National Institute for Health Care Management
"appears to be little more than a political and financially motivated cheap
shot masquerading as science in the public interest."
While it has been known for some time that many of the drugs approved were
similar to existing medicines, the institute's study appears to be the first
to use data from the F.D.A. to try to determine just how prevalent these
medicines are. Often such modified versions of medicines are called me-too
Of the 1,035 drugs approved by the F.D.A. from 1989 to 2000, only 361, or 35
percent, contained new active ingredients, the study said. The rest
contained active ingredients that were already available in other medicines
on the market.
Of those 361 drugs, fewer than half were given priority reviews by the
F.D.A. because of their significance. The agency grants priority reviews to
medicines that are believed to be more effective, have fewer side effects or
otherwise perform better than existing drugs.
Considering those statistics, the institute found that highly innovative new
medicines ? those with new chemical ingredients that offer significant
improvements over existing drugs ? made up only 15 percent of those approved
in the period. These medicines included Fosamax, for osteoporosis; Avandia
and Actos, for diabetes; and Viagra, for erectile dysfunction.
The study said that drug companies were increasingly relying on the me-too
products as patents on top-selling drugs expired, and they could not
discover enough truly new medicines to increase revenue as fast as investors
The modified drugs also provide a high return on investment, the study
stated, since developing them is much less expensive and also less
time-consuming than trying to find a new medicine.
"This is more evidence that the pharmaceutical companies are turning more
into marketing companies," Ms. Chockley said. By using advertising to sell
drugs that are essentially line extensions of existing medicines, she said,
the companies have learned to be like Procter & Gamble, the maker of Tide.
The institute's study said that the modified medicines were often more
expensive than were older medicines, even if the F.D.A. had found that they
did not offer significant advantages. In 2000, the average price of a
modified drug not given a priority review by the F.D.A. was about $65 ?
almost double the price of a drug approved before 1995, the study said.
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