Posted on 01/26/2004 7:39:45 AM PST by Pharmboy
LONDON/NEW YORK (Reuters) - With "superbugs" stalking hospitals and old killers such as tuberculosis re-emerging, the world badly needs more powerful antibiotics.
Yet the pipeline of new treatments is drying up as drugmakers -- citing poor financial returns -- focus instead on chronic conditions, such as high cholesterol, where medicines are taken for years rather than curing patients in one or two weeks.
The shrinking of the medical armory is a growing worry for health care officials and has sparked a debate between regulators and pharmaceutical companies over ways to kick-start investment.
"The relative lack of research on anti-microbials is a matter of concern and it does relate partly to the financial returns on their use," said Richard Laing, an expert on medicine policy at the World Health Organization in Geneva.
"There is clearly a potential risk, due to growing drug resistance, that there won't be any effective anti-microbials available in the future."
In the battle between man and microbe, multidrug-resistant bacteria -- or superbugs -- are gaining the upper hand.
MRSA (methicillin-resistant staphylococcus aureus) strains once confined to hospitals are now found in the wider community, and some infections even shrug off vancomycin, traditionally the antibiotic of last resort.
'PERFECT STORM'
The Infectious Diseases Society of America, representing more than 7,500 physicians and scientists, said in a report last month that a "perfect storm" was brewing in infectious diseases.
Only nine new antibiotics have been approved since 1998, of which just two had a novel mechanism of action -- and the annual reports of major drug companies list a mere five new antibiotics in development out of more than 400 agents in total.
Some firms like Eli Lilly and Co. and Roche Holding AG have pulled out of the antibiotic arena, while many others have severely curtailed investment.
The industry says the economics simply do not stack up.
"Companies won't develop any drug now unless they think it can make peak annual sales of $400 million to $500 million, so they're giving up on antibiotics," said industry veteran Francis Tally, who used to run Wyeth's (then American Home Products') Lederle antibiotic unit a decade ago.
Today, he is chief scientific officer of Cubist Pharmaceuticals Inc., which last year became the first biotech firm to launch a new antibiotic, Cubicin.
While many pharmaceuticals show double-digit sales growth, the antibiotic market is flat and could decline with the arrival of cheap generic copies of two big sellers, GlaxoSmithKline Plc's Augmentin and Bayer AG's Cipro.
REGULATORY HURDLE
For the few new antibiotics that have made it to market -- such as Pfizer Inc.'s Zyvox -- the financial returns have been meager at a time when the regulatory hurdle has increased.
"The regulatory requirements have risen to a level that has meant companies can no longer see the investment would be justified," said Trevor Jones, director general of the Association of the British Pharmaceuticals Industry, representing some of Europe's biggest drug makers.
The fate of Aventis SA's new Ketek antibiotic has highlighted the problem for many pharmaceutical executives. To satisfy regulators, the Franco-German company had to conduct a huge -- and costly -- 24,000-patient study.
"That scared a lot of drug companies because it still has not been approved in the United States," said Tally. "The other thing that is scaring off big pharma is that if you do have a drug against resistant strains of bacteria, hospitals restrict use of it. They hold it in reserve, which cuts down on sales."
In a bid to revive antibiotic development, drug companies are lobbying both the U.S. Food and Drug Administration (news - web sites) and the European Medicines Evaluation Agency for "sweeteners" that could make investment in new antibiotics more attractive.
Options include relaxing some of the clinical trial rules, in recognition of that fact that last-resort treatments are unlikely to be used on more than a small number of patients.
Another idea favored by industry is extending the patent life of certain medicines, on condition profits are reinvested in R&D. But at a time when the pharmaceutical industry is under fire over patents on AIDS (news - web sites) drugs and stands accused of fueling runaway health care costs, that could be a hard one to sell.
Price controls take their toll. We have been subsidizing the socialist democracies of Europe with US drug profits. The handwriting is on the wall...
Just wait until they "regulate" the prices of all drugs...which is coming as all medication "benefits" become federalized...zero or negative profit for new medications..."not in the formulary"...take a dirt nap.
--Boris
Pretty much explains most of the problem.
The US is the only major market in the world that pharm companies can charge a profit. It can take between 2-6 billion dollars to research and bring a drug into the market with 3-5 years to recoup the investment.
Enough of Hillarycare was passed that the pharm companies have been crunched in the US market. I used to work for a software company that developed software for the pharm companies. The company went out of business because all the pharm companies had to cut back drastically - all pharm companies are struggling to stay in the black right now.
If price controls or Canadian buying schemes pass, development of new drugs will be brought to a standstill.
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