New Drugs Not New.

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New York Times

29 May 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 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.

 

 

 

 

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