In a wide-scale scenario, antibiotics losing efficiency in consequence of patient and doctor negligence would force unwelcome changes in almost every aspect of medical practice. As the threat of bacterial “superbugs” grows ever more likely, and pharmaceutical companies stop producing new antibiotics because they don’t yield high profits, the concerns some have over the current status of antibiotics is hard to understate.
One of these persons is Michael Kinch, PhD, the associate vice chancellor and director of the Center for Research Innovation in Business.
Throughout an article in Drug Discovery Today, Kinch discusses economic concerns in the pharmaceutical industry which led to the current lack of antibiotic supply. The number of antibiotics available for clinical use has decreased to 96 from a peak of 113 in 2000, the report shows.
The big scare factor comes from the rate of antibiotic withdrawals, which is double the rate of new medicines being introduced into the market. Pharmaceutical companies are removing antibiotics because they don’t work anymore, they’re too toxic or because they’ve been replaced by new versions of the same drug, according to a news release by Washington University in St. Louis. New antibiotics are not being brought to market because pharmaceutical companies don’t make a profit on the drugs in consequence of the high costs associated with antibiotic discovery and development.
Pfizer, or its predecessors, developed 40 of the 155 antibiotics ever sold in the U.S., Kinch said. However, the company has since ceased developing and manufacturing antibiotics. Eli Lilly, AstraZeneca and Bristol-Myers Squibb have also quit the antibiotic vertical, which, Kinch said, is now dominated by small companies such as Cubist Pharmaceutical that focuses on drug-resistant bacterial infections, which could sell to consumers for a higher price.
Kinch said his stated amount of 96 antibiotics still available might be overestimated because some of the new drugs are not general-purpose antibiotics, but created for special occasions such as anthrax treatments.
The chief reason pharmaceutical companies are no longer investing in antibiotics is that the U.S. patent law squeezes them for time before a generic version can be created. A patent gives a company 20 years of ingredient protection for a new drug, but it takes on average 11 years of clinical trial experience before the FDA approves a new drug, which leaves companies only nine years to make up the investment costs and turn a profit, before a cheaper generic version pops into play.
“Because the drug market is not really a free, unfettered market, the current antibiotic quandary is not really due to a shortcoming of private enterprise,” says Ken Perez, the vice president of healthcare policy at Omnicell, a pharmacy automation company based in Mountain View, Calif. “The drug approval process has lengthened from an average of eight years about a decade ago to 11 years today, leaving pharmaceutical companies only nine years to recoup their investment in a drug before generics enter the market, usually decreasing brand name sales by 80 percent within a year.”
One solution that has been proposed in the past is to give drugmakers 15 years from the drug’s approval date to sell it, and not allow for patent extensions which usually result in litigation and FDA freezing approvals of generics for 30 months, Perez says.
However, if the drug being patented is an antibiotic, there is an additional catch. Because of rising bacterial resistance to drugs, doctors are holding newly developed antibiotics in reserve, and using them only in desperate cases which means drugs are literally sitting on shelves not being purchased.
Antibiotics are not the only drug type heading toward being phased out. Kinch said that HIV/AIDs drugs are following a similar trajectory, and have become the “poster child for the larger problem of drug discovery and development in part because they underpin every part of modern medical practice, from surgery to cancer treatment and pretty much everything in between,” the news release stated.
Information from this report is via materials from Science Daily and Washington University in St. Louis.