BY DR. ROBERT GOLDBERG – For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.
That’s why it’s so alarming that only 21 new drugs gained FDA approval last year. This was a significant decrease from the previous two years — there were 25 approvals in 2009, and 24 in 2008.
Not only are approvals down, so are applications for approval. This fact portends even further declines in annual approvals down the road. With science more cutting-edge today than yesterday and grants for new research in areas from pediatrics to Alzheimer’s at all-time highs, how is it possible that approvals and applications are both dropping?
The FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid. The FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.
Of the 21 drugs approved in 2010, there were 21 drugmakers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of whom were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter. Analysts estimate 2010’s lost sales due to the FDA’s delays ran upwards of $1 billion.
And the problem is not limited to medicines. The development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion. Tests and medical that can help detect and prevent disease and eliminate useless or even harmful care are ironically being held up in the name of ‘patient safety.’
Government policy writ large has now begun to stifle innovation in pharmaceuticals. ObamaCare levies tens of billions in taxes on new medical products through 2019. Comparative effectiveness studies required even after FDA approval as a condition for being added to Obamacare benefits, will delay progress too.
Even worse is that FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.
Sound far-fetched? It isn’t. Consider the case of $8,000-per-month Avastin, an anti-cancer wonder drug that blocks blood flow to tumors. In 2007, the FDA granted accelerated approval for the use of Avastin for treatment of metastatic breast cancer. It was clear from the Avastin studies then that while many women would not benefit from the drug, a significant minority could live longer and with less pain. The FDA asked Avastin researchers to evaluate the drug’s risks and benefits on a larger group of patients with the same standards used to approve the drug in the first place. The study confirmed the 2007 results showing benefit to specific groups of women. But the FDA revoked Avastin’s approval for breast cancer treatment because it didn’t extend life on average.
This is not the first time the FDA has changed gears. It yanked Iressa, a lung cancer drug, after post-approval studies looking at average survival showed no benefit. Additional studies were done to identify subgroups and fine that patients with a certain genetic mutation lived longer. And last year researchers found that Iressa can prevent pancreatic cancer from coming back after other therapies stop it. Innovation is the result, not of a top-down decision, but by learning from actually using an invention. Taking products off the market therefore undermines medical progress in many cases.
As a result of the FDA’s slow-to-act review process, ObamaCare’s disproportionate taxation of pharmaceutical firms, and this recent Avastin decision, innovation is in a very precarious position. Most medical innovations come from start-ups with limited capital. For all the happy talk about supporting innovation and small businesses, the trifecta of government tactics is doing just the opposite. Just this month, the Director of the Tufts Center for the Study of Drug Development, Kenneth Kaitin, registered his concern: “The question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”
Meanwhile, China, India and Singapore are inviting America’s innovators to set up shop overseas. As the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately. Not only are we losing innovation, we are losing lives as well.
Dr. Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest. He is also author of the new book Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit (Kaplan).