blog.nj.com/njv_guest_blog/2011/03/losst_innovation_may_mean_lost.html
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 portends even further declines in annual approvals down the road. With science more cutting edge today 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 drug makers 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 which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.
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 efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.
Government policy writ large has now begun to stifle innovation in pharmaceuticals. Obama’s health care plan 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 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.
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, the Obama health care plan’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, Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, 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.
