Watch out, the Food and Drug Administration may give you a cold
It was a mystery that had remained unsolved throughout history, but diligent, masterful scientists have now finally figured out a likely way to cure the common cold, leaving another, difficult task for others. That's how to persuade the federal government to back off sufficiently to get new, effective cold drugs on the market.
The researchers at universities in Maryland and Wisconsin made their discovery through a powerful instrument that could just maybe transform this world we live in someday, the decoding of genetic material. And the prospect could be something more than alleviating the sneezing, wheezing, coughing, sniffling misery that is said to cost victims tens of billions a year while often holding them prisoners in their homes.
As a New York Times piece points out, colds also prompt asthma attacks and aggravate chronic obstructive pulmonary diseases. Millions are afflicted by these ailments and would no doubt be thrilled by the relief clever genetic engineering might bring if the pharmaceutical industry did not have to put up with some of the obstacles thrown its way by the Food and Drug Administration.
A problem with the FDA is that it tests a drug past the point where it needs to, pointlessly prolonging the period from the beginning of the drug's development to its conclusion and astronomically raising the costs to drug companies. Said Henry Miller in an article some years ago, the American people "are victims of an overly risk-averse regulatory system that favors delay, rewards excessive zeal, inhibits innovation and denies life-saving products to people who need them."
A research scientist and physician now at the Hoover Institution at Stanford University, Miller was once with the FDA and recounts in the article an experience there to illustrate his point. He was heading a team that, within four months, had found solid evidence of the safety and efficacy of a gene-spliced drug to treat diabetes. Then a supervisor intervened, saying the research ought to take still longer, not because that was necessary, but because the agency would look "bad" if something later went awry.
Miller's recent work expresses the hope that the Obama administration will expedite those FDA evaluations that chew up more time than can be justified -- that the agency will be held accountable for inefficiency that can have devastating health consequences for the American public. Achieve as much, and maybe a new drug curing the common cold would not cost something on the order of $700 million or more to develop. As the Times article says, that kind of cost could translate into a drug price outweighing what consumers would want to pay to fix a cold, at least if the drug company wanted a profit.
Yes, I know, "profit" is a dirty word to some, especially -- in the moment's fiercely anti-corporate mood. If anything, more regulation seems in the offing throughout the federal government, not less, and Barack Obama himself may well lead the charge. His comments during his campaign indicated he was far more interested in bashing the drug industry for high drug prices than acknowledging the government's role in making those prices high.
So what happens if you do something as extreme as we have witnessed in Europe and Canada, which is to institute price controls to keep profits and prices down? Facts I've encountered speak for themselves -- something like three quarters of the world's new, important drugs are developed in the United States. As an economist friend of mine puts it succinctly, incentives matter.
If we do as the Europeans do, it's clear enough what will happen. We will save money but do without all the new drug innovations that can in some cases save our lives and, in others, simply keep us from the aggravation of a cold. As someone who has a cold as I write this, I vote for incentives.
-- Ambrose, formerly Washington director of editorial policy for Scripps Howard newspapers and the editor of dailies in El Paso, Texas and Denver,
is a columnist living in Colorado