[Ip-health] New Medicines Seldom Contain Anything New, Study Finds

[James Love]

This is an older NYT article I think I missed before.  The report it
refers to is on the web here: http://www.nihcm.org/innovations.pdf
   Jamie

May 29, 2002, Wednesday

BUSINESS/FINANCIAL DESK

New Medicines Seldom Contain Anything New, Study Finds

By MELODY PETERSEN (NYT) 797 words
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 another.

''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 drugs.

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 expected.

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.

CAPTIONS:


--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040