At A Time When There Are Many Drug Resistant Strains Developing...

March 15, 2004

Firms abandoning antibiotics research

Drugs that make more money sought

By Christopher 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. John 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 Thomas 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. Stephen 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 John 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 Robert 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 Thomas 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."

Christopher Rowland can be reached at crowland.Do you ?

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March 16, 2004

Here are some links to "health freedom" organizations. I searched them out on the web. We should get involved as we can and do something to protect ourselves before they make us "criminals" for trying to stay in health.

http://www.iahf.com/ http://www.apma.net/ http://www.apma.net/ http://www.apma.net/

http://www.thenhf.com/

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