The vaccine makers are in a bind — and public health is in danger.
By Jonathan (Josh) Bloom, Ph.D., Gilbert Ross, M.D.
Posted: Monday, December 20, 2010
Publication Date: December 20, 2010
The development of new antibiotics has slowed to a trickle, just when we need them most. As drug-resistant bacteria are on the rampage worldwide, we find ourselves in a most precarious situation — one not unlike the one we faced in the pre-antibiotic era, before penicillin, when staphylococcal and pneumococcal infections were the dominant pathogens. Now MRSA (Methicillin-resistant Staphylococcus aureus) kills more people than AIDS every year, and other multiple-drug-resistant organisms have appeared, leaving doctors with few therapeutic weapons for treating a number of prevalent infections.
How did this happen? Much of the blame can be laid at the feet of the FDA.
In the mid-1990s, the FDA tightened up rules for approval of new antibiotics, requiring companies to provide evidence that not only was a new drug candidate effective and safe, but it was also more effective than existing antibiotics. Bad move. The drug regulators also began requiring that more patients be enrolled in clinical trials, increasing the cost of drug development. The results were predictable — drug companies dropped out of antibiotic research en masse.
This trend is clearly demonstrated in the number of new antibiotics. In successive four-year periods beginning in 1983, the number of new antibiotics approved has dropped from 16 (in the period from 1983 to 1987), to 14, 10, 7, and 4 (in the period from 2003 to 2007). And it’s getting worse, not better: only two since 2007. With so many companies having discontinued antibiotic research, the current pipeline is very weak, so it is unlikely that any magic bullets will soon appear on the horizon.
This repeats a pattern seen two decades ago from which we failed to learn — what happened when the vaccine-development process was made too onerous and expensive. In 1984, Wyeth Laboratories announced that it would no longer produce its pertussis (whooping cough) vaccine, which the company had been manufacturing for three decades. This was a continuation of an alarming trend, in which most vaccine makers had dropped out of the market, mostly because of the escalating cost of protecting themselves from predatory and frivolous lawsuits. By 1984, the number of companies producing the flu vaccine had fallen by more than half, and the only live-polio-vaccine maker left was Lederle Laboratories.
In response to this problem, Congress created the Vaccines for Children Program (VFCP) in 1986. This was designed to provide a mechanism through which a child actually sickened by a vaccine could receive a settlement from a pool funded by fees collected from the vaccine makers. The fees were high — greater than 25 percent of the cost of the DPT vaccine — and the parents of the affected children could still opt out of the program and file civil suits. Despite this program, costs continued to skyrocket, and between 1988 and 2001, ten of 14 global vaccine makers stopped making routine childhood vaccines. Today just four companies are responsible for producing 80 percent of the world’s vaccines. And not surprisingly, between 2000 and 2003, there were unprecedented shortages of eight of the eleven vaccines routinely given to children.
Now, more than 20 years have passed, and Congress has finally awoken to the urgent need to encourage new antibiotic development. Our lawmakers are considering offering drug companies patent extensions and tax breaks, which are intended to eventually regenerate a development pipeline for new antibiotics. Whether this extension will provide a sufficient incentive for drug companies is not clear, since antibiotics are far less profitable than drugs that must be taken for chronic conditions. But even in the best-case scenario, the flow of effective new drugs to combat resistant bacteria won’t start for several years.
Meanwhile, the bugs keep growing and mutating. If the resistance problem jumps ahead of the discovery process, we may again find ourselves with no reliable weapon against infection. Perhaps summing it up best, Dr. Brad Spellberg of the Harbor UCLA Medical Center said: “For these infections we’re back to dancing around a bubbling cauldron while rubbing two chicken bones together.”
— Josh Bloom, Ph.D., is director of public health, and Gilbert Ross, M.D., is medical director, of the American Council on Science and Health.