Home » Our Hopes for a Longer & Better Life — A New Take on the FDA Drug-Approval Process

Our Hopes for a Longer & Better Life — A New Take on the FDA Drug-Approval Process

by Louis J. Wasser

Consider the lucky patient who, back in the early 90s, visited his doctor for allergy symptoms and was given a prescription for the antihistamine Seldane (the brand name for Terfenadine).  He experienced instant relief.  But if he visited his doctor again in 1998 and complained of the same symptoms, he was told that Seldane had just been taken off the market.

A patient with back pain would have had a similar experience with relief from arthritis symptoms, taking an amazing drug called Vioxx (the brand name for Rofecoxib) in 1999.  Going back to her doctor in 2004, she would be told the FDA had ordered Merck & Co to withdraw this “miracle drug” from the market.

In 2010, the FDA banned the drug Darvocet from the market because it contained propoxyphene, which Web MD has called “a safety-plagued painkiller from the 1950s.”  As a result, some 10 million patients were suddenly forced to ask their physicians to prescribe a substitute painkiller.  But Web MD warned these patients not to stop immediately taking Darvocet, because to do so might entail “serious withdrawal symptoms.”

Taking a so-called “miracle drug” can be like going on a hot first date with someone you hardly know.  You feel wonderful and on top of the world — for a very brief time.  Then you discover your new lover has a menacing past, and you have to put an immediate end to the affair.

What are we to make of the Food & Drug Administration (the FDA), the regulatory agency that’s been frequently accused of letting things slide, overlooking botched clinical trials, and out-and-out negligence?  It green-lights drugs for manufacture and distribution, whereupon hoards of pharmaceutical salesmen peddle these new wares to physicians across the country; and you and I are left to endure prime-time TV commercials with a rapid-fire recitation of side effects we can barely wrap our minds around.

The FDA, for all its bureaucratic fumbling, is still the best method we have for giving safe passage to new drugs on to the marketplace.  While drugs do things for you, they also do things to you.  And despite our need for pain relief, our need to go to sleep, and our need to lower our cholesterol, it’s always a good idea to question our physicians and pharmacists closely about our prescription drugs.

Meanwhile, we still owe ourselves a shot at a longer and better life through the best available medications.  One way to do this is to take some of pressure off the FDA and the drug companies through what MIT financial engineer Roger Stein calls “risk mitigation.”  In a recent TED talk, Stein outlines a bold proposal whereby the 20-year backlog of drugs that now exists is treated as a set of financial assets.

He and his colleagues have put together a model for a fund that can be developed on the capital marketplace.  The fund managers would solicit a fund into which pension and retirement funds could buy.  Most of the drugs would fall out along the way during development.  But the few that make it through the bottleneck would produce handsome enough revenues in a fund that could easily pay out 5% interest and a 12% equity return over the long haul.

Stein and his colleagues have run the numbers, and insist that they work.  If indeed they do, our hopes for a longer and better life are not all that remote.

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