The US pharmaceutical landscape has changed rapidly and radically over the past decade — with dire consequences. Companies have exited en masse from research in traditional disease areas, plunging headfirst into cancer research.
The result: We’re getting lots of new not-especially-valuable cancer drugs, and not getting new pharmaceuticals we need far worse — in particular, new antibiotics to combat the nonstop emergence of resistant “superbugs.”
These bacteria are relentlessly growing more resistant to whatever few antibiotics are still effective in stopping them. They kill 90,000 Americans a year, and rising – and threaten to turn our hospitals into death traps.
A new report from The Infectious Diseases Society of America is especially grim. The society launched a 2010 initiative called “10 x ’20” — a modest proposal designed to have 10 new systemic antibiotics approved by 2020. It is failing miserably: Three years into the initiative, the Food and Drug Administration has approved only one new antibiotic.
And there are only seven antibiotics in development, with a significant chance that any or all won’t actually pan out.
Yet the FDA approved 11 new cancer drugs in 2012 alone.
How did this happen? Simply put, the FDA essentially pushed the drug companies to change direction.
For years now, the FDA has been under intense political pressure to speed up the approval of new medicines. In response, it’s now allowing shorter, less expensive clinical trials for cancer drugs — the one area where it won’t face criticism when safety issues inevitably arise. This effectively lowers the bar for development of oncology drugs.
But back in the 1990s, the agency took the opposite stance with antibiotic development. It began requiring prohibitively expensive, time-consuming and impractical clinical trials — making it virtually impossible for companies to develop any new antibiotic, let alone a profitable one.
Drug companies responded as you’d expect — by dropping out of antibiotic research and moving into other research areas, mainly oncology.
So, rather than a healthy pipeline of vital new antibiotics, we are instead seeing the approval of multiple expensive cancer drugs, often with marginal benefits.
For example, when Sanofi’s Zaltrap (which originally cost $130,000 per year, but is now discounted to about half that) plus standard chemotherapy was given to patients with metastatic colon cancer they lived an average of 13.5 months. Those getting chemotherapy alone lived 12 months.
Likewise, Pfizer’s Inlyta, which was approved to treat advanced kidney cancer, provides patients with 6.7 months of progression-free survival time, as opposed to 4.7 months for those on conventional chemotherapy.
To be fair, it’s not that drug companies are putting suboptimal cancer products on the market solely for economic gain.
Derek Lowe, creator of “In the Pipeline,” the premier blog in the world of pharmaceutical research, and himself a cancer researcher, explains: “It’s not like we’re trying to find something that just extends a cancer patient’s life by four months.”
Rather, “We try all these mechanisms that look, biologically, like they might really work. It’s just that cancers are too heterogeneous and unstable — they mutate their way around a lot of our good ideas, and the cells that remain roar back in an untreatable form.”
In other words, cancer remains a tough nut despite enormous amounts of research thrown at it.
Meanwhile, antibiotic research continues to decline despite the looming crisis.
The FDA is showing signs of easing its requirements, it may be too late. Only four major pharmaceutical companies remain in antibiotic R&D at all. Of these, AstraZeneca, which has two of the seven drugs in development, plans to cut back research in the area.
Even if companies rush to restart this research, it will take years to show results.
Thanks to the FDA, we may soon see hundreds of thousands of people dying from previously treatable infections while we continue to churn out cancer drugs by the dozens.
Josh Bloom is the director of chemical and pharmaceutical sciences at the American Council on Science and Health.