Friday, December 22, 2006

One Pill That's Good for You--The Truth

Every time Walter Pidgeon’s character, Dr. Morbius, felt threatened by jealousy or fear in the movie, “Forbidden Planet,” he unconsciously sent out “monsters from the Id” to attack and kill innocent members of the crew sent from earth to save him. Just like Morbius, big pharma is sending out it’s monsters of the Id—shills, in other words—to lubricate the electorate against the big bad democratic congress coming in next month threatening to protect its constituency—us—from high drug costs and unsafe new drugs. The protective measures bandied about include government controls on runaway prescription drug costs for seniors, and bringing new patents to market with enough testing to make them safer than, say, vioxx, zyprexa, and other potentially dangerous, and hugely-profitable, concoctions.

It may be overstating the case to label every pro-pharmaceutical company advocate a “shill.” But the arguments against the policies of megalithic drug firms generally try to show a way to make drugs cheaper and safer. The proponents of these policies make specious claims regarding the lack of monetary incentives driving down the numbers of great new drugs coming to market. In any statistics I’ve ever read, the latter is a joke, mostly perpetrated on the consumer to get him or her to pony up the exorbitant price of what could actually save or prolong their lives.

The latest nonsense written about the poor beaten down drug companies is an op-ed piece in the Los Angeles Times today, by Richard Epstein, described as “Richard A. Epstein, RICHARD A. EPSTEIN is a professor of law at the University of Chicago and a senior fellow at the Hoover Institution who has often consulted for the pharmaceutical industry.”

THE PHARMACEUTICAL industry is getting bad press. Recent books by Marcia Angell, the former editor of the New England Journal of Medicine, and Jerome Kassirer, another former editor of the journal, have harshly condemned the industry for recklessness, insensitivity and all-consuming greed. They gain sales by spicing up their titles with inflammatory phrases about "deception," "complicity" and how drug companies "endanger your health."

I take a different approach. I don't defend every business decision made by the great pharmaceutical research houses. To the contrary, much recent commentary suggests that many such companies have committed themselves to a blockbuster-drug model — in which a company's success or failure depends on a few vital, high-selling drugs — that may prove unsustainable over the long haul. If so, I believe that those firms should suffer the financial consequences of their mistaken business choices. Government bailouts are no more appropriate for Merck and Pfizer than they are for Chrysler or Ford.

Here’s the letter I wrote to the Times regarding Epstein’s editorial. I’ll let you know if it gets printed:

Re: The myth of the big bad drug companies

In his ridiculous op-ed piece, Richard Epstein quickly glosses over “Ever-tougher conflict-of-interest rules in the National Institutes of Health and such academic medical centers as the University of Pennsylvania, Stanford and Yale…” Is he implying it’s better to have physicians get paid by the same big pharma companies for whom they act as spokesmen and consultants on new drugs?

“More stringent requirements for clinical drug trials — including rules that demand larger test populations and more extensive documentation — have reduced the flow of new drugs to market.” How’s this a bad idea again? Would it be better to have more disasters like Vioxx and Zyprexa on the market in lieu of more stringent testing?

Epstein bemoans the high price of new patent drugs: “It costs, on average, more than a billion dollars to get the first pill to market.” Statistics prove that at least half that cost comes directly from the US government. Wouldn’t the auto-companies be thrilled to get that kind of R & D aid?

The bio blurb says that Epstein “has often consulted for the pharmaceutical industry.” Ya think?

Here’s what Marcia Angell (Senior Lecturer in Social Medicine at Harvard Medical School. A physician, she is a former Editor in Chief of The New England Journal of Medicine. Her latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.) wrote about the same subject:

…research and development (R&D) is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits. In fact, year after year, for over two decades, this industry has been far and away the most profitable in the United States. (In 2003, for the first time, the industry lost its first-place position, coming in third, behind "mining, crude oil production," and "commercial banks.") The prices drug companies charge have little relationship to the costs of making the drugs and could be cut dramatically without coming anywhere close to threatening R&D.

Second, the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). The great majority of "new" drugs are not new at all but merely variations of older drugs already on the market. These are called "me-too" drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first.

…Third, the industry is hardly a model of American free enterprise. To be sure, it is free to decide which drugs to develop (me-too drugs instead of innovative ones, for instance), and it is free to price them as high as the traffic will bear, but it is utterly dependent on government-granted monopolies—in the form of patents and Food and Drug Administration (FDA)–approved exclusive marketing rights. If it is not particularly innovative in discovering new drugs, it is highly innovative— and aggressive—in dreaming up ways to extend its monopoly rights.

And there is nothing peculiarly American about this industry. It is the very essence of a global enterprise. Roughly half of the largest drug companies are based in Europe. (The exact count shifts because of mergers.) In 2002, the top ten were the American companies Pfizer, Merck, Johnson & Johnson, Bristol-Myers Squibb, and Wyeth formerly American Home Products); the British companies GlaxoSmithKline and AstraZeneca; the Swiss companies Novartis and Roche; and the French company Aventis (which in 2004 merged with another French company, Sanafi Synthelabo, putting it in third place)... All are much alike in their operations. All price their drugs much higher here than in other markets.

Since the United States is the major profit center, it is simply good public relations for drug companies to pass themselves off as American, whether they are or not.

Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)

Ouch—that’s the truth hurting!!

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