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From: msnaturally@... Add to Address Book

Date: Sun, 14 Mar 2004 13:07:23 EST

Subject: [MSherbdoc] Fwd: [nspadvisor] Firms abandoning antibiotics

research

In a message dated 3/14/2004 1:01:09 PM Eastern Standard Time,

Reclaimedhealth writes:

Firms abandoning antibiotics research

Drugs that make more money sought

By Rowland, Globe Staff, 3/13/2004

America's drug industry, including anti-infection pioneers Eli Lilly

& Co.

and Wyeth, is abandoning research into antibiotics in favor of more

lucrative

drugs at a time when patients need new versions to fight drug-

resistant bacteria.

New antibiotic research has taken a back seat because companies are

chasing

larger drug markets that promise bigger profits such as pills for

depression,

heartburn, and erectile dysfunction. The shift to treat chronic

ailments and

" lifestyle " complaints is of growing concern among infectious disease

doctors

who say market conditions are steering manufacturers away from areas

of critical

medical need.

" Thirty years ago, antibiotics were what drug companies did, " said

Dr.

Bartlett, chairman of the Infectious Disease Society of America's

task force on

antimicrobial availability. " Now they have a much richer portfolio,

and the

other drugs are more attractive. "

Indeed, for big drug companies, there isn't much economic incentive

to create

new antibiotics. The potential market for a new antibiotic is an

estimated

$200 million to $400 million in sales a year, doctors say. In

contrast, Pfizer

Inc. sold $9.3 billion last year of Lipitor, its anticholesterol

treatment that

is the world's best-selling drug.

The reason for the huge difference is that a patient typically needs

to take

an antibiotic for an infection once a year for seven days, while to

treat a

chronic condition such as high cholesterol or depression requires a

pill every

day for the rest of the patient's life, said Dr. Girish Tyagi, a drug

industry

analyst at Weisel Partners in Boston.

The Food and Drug Administration approved only two new antibiotics in

2003,

and none were approved in 2002. That's a fraction of the number of

antibiotics

approved during the 1980s and early 1990s. For example, from 1983

through

1992, 30 new antibiotics won FDA approval. Over the next 10 years,

just 17 were

approved. In an analysis of recent annual reports of 15 major drug

companies,

the Infectious Disease Society of America found that only 5 of more

than 400

drugs in development were antibiotics.

Serious medical consequences could result, doctors warn. Antibiotics

kill

microorganisms that cause common diseases like sinusitis and

pneumonia. What's

more, many types of bacteria are developing resistance to the

existing class of

antibiotics, including germs that cause tuberculosis, pneumonia, and

gonorrhea. Hospital infections pose a particular worry because they

cause an estimated

90,000 deaths a year, and antibiotics are the only drugs to combat

them.

" If we don't have new drugs, I would say within 10 to 20 years we may

have

bacteria we can't treat, " said Dr. Zinner, a Harvard Medical

School

professor and chairman of medicine at Mount Auburn Hospital in

Cambridge.

Among the key companies that have withdrawn or made deep cuts in

antibiotic

research over the past two years are Bristol-Myers Squibb Co., Wyeth,

and Eli

Lilly & Co., which all have long traditions of developing life-saving

antibiotics for generations of Americans. Wyeth developed

tetracycline in 1947. Lilly

was among the first companies to mass-produce penicillin and it

developed

erythromycin and vancomycin in the 1950s. Bristol-Myers Squibb also

mass-produced

penicillin.

Drug makers say the high costs of development make it difficult to

pursue

antibiotics when the markets are relatively small. They say

antibiotic research

has advanced to such a state that it's hard to keep wringing out

improvements.

There is a paradoxical twist that further discourages new

development: With

the rise of drug-resistant strains of bacteria, physicians and

scientists are

urging sparing use of antibiotics because their overuse exacerbates

the problem

-- hardly an environment for powerful sales growth.

" I really believe it is an unintended predicament, " said

Leonard, vice

president of global pharmaceutical development at Abbott

Laboratories, which

has halted new antibiotic discovery efforts. " It's not purely a

regulatory

issue. It's not purely an incentives issue. "

Wyeth has only one more antibiotic in development -- tigecycline, to

treat

hospital-related infections -- its last because of the high expense,

said

Ruffolo, Wyeth president of research and development. Wyeth has

already cut

the number of antibiotic investigators from 80 to fewer than 15.

Declining antibiotic research fits a broader pattern in the drug

industry to

shun treatments for illnesses that don't reap big profits, says

Croghan, a senior natural scientist at Rand Corp., a nonprofit think

tank with

offices in California and Virginia. For example, instead of focusing

on a cure for

degenerative arthritis, drug companies have produced expensive new

drugs like

Celebrex, manufactured by Pfizer, to treat chronic arthritis pain.

The

government, Croghan said, through the FDA and the National Institutes

of Health, could

do a better job of guiding industry to target serious diseases.

" Companies are increasingly dependent on blockbuster drugs in order

to

maximize revenues, " said Croghan. " What we need to do is set our

priorities based on

our national needs. "

The FDA says it has encouraged drug companies to develop new

antibiotics but

with little success. " It has proven to be challenging for the

pharmaceutical

industry to look and develop new compounds that are active and have a

reasonable safety profile and appear to have a significant market, "

said Dr. Mark

Goldberger, acting deputy director of the FDA's Center for Drug

Evaluation and

Research.

The reassignment of laboratory scientists from antibiotic research

into other

fields worries doctors like Bartlett of the Infectious Disease

Society of

America. " Once that shift has been made, " he said, " you have the

feeling that you

have lost that science. "

© Copyright 2004 Globe Newspaper Company.

http://www.boston.com/news/nation/articles/2004/03/13/firms_abandoning

_antibio

tics_research/

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