I never knew my maternal
grandparents. During the nineteen-teens, my maternal grandmother died of a
wound infection following a routine gall-bladder operation. A few years later,
her husband suffered a fatal stroke brought on by untreated high blood pressure.
Both were in their thirties.
Neither occurrence was uncommon back then, but a half-century of new drugs has
changed that. Thanks to a research-intensive (and, therefore,
capital-intensive) pharmaceutical industry, pharmacy shelves now contain dozens
of antibiotics and blood pressure medications. Similar treatments are available
as well for other medical problems, such as arthritis, hypertension, abnormal
lipids, and heart failure, and new vaccines have virtually eradicated many
dreaded childhood illnesses. Moreover, greater understanding of the molecular
mechanisms of disease has provided the wherewithal to make these drugs far
safer and more effective.
These stunning successes notwithstanding, the pharmaceutical industry has
become a lightning rod for critics. In her new book, The Truth About the
Drug Companies: How They Deceive Us and What to Do About It, Marcia Angell,
Harvard Medical School lecturer and former editor of the New England Journal of
Medicine, blasts the drug industry, accusing it of profiteering, having become
"a marketing machine to sell drugs of dubious benefit," and using
"its wealth and power to co-opt every institution that might stand in its
way, including the U.S. Congress, the FDA, academic medical centers, and the
medical profession itself."
Dr. Angell maintains that the pharmaceutical industry's reputation for
innovation is a myth, that in fact it "feeds off the NIH" and that
new drugs "nearly always stem from publicly supported research." She
makes much of the fact that the drug industry, "corrupted by easy profits
and greed," has high marketing and administrative costs, and blames the
companies for the paucity of genuinely innovative and affordable new drugs.
Many of these accusations are questionable; some are patently unfair or untrue.
In 1999, the NIH thoroughly investigated whether its research funding commonly
leads to the development of pharmaceuticals, the profits from which taxpayers
might be entitled to share. Of 47 drugs that had earned revenues of $500
million or more, NIH support had figured significantly in only four, two of
which were actually the same drug. The NIH supports primarily pre-commercial,
fundamental research into the biochemistry, physiology and molecular biology of
cells and organisms, in health and disease.
Dr. Angell's analysis of companies' profitability downplays their huge
investments in R&D. The U.S. research-based pharmaceutical industry (that is,
excluding companies that make generic drugs) currently spends upwards of $33
billion annually on R&D. Moreover, it invests in research and development a
far greater percentage of sales (17.7 per cent) than any other industrial
sector, including electronics (6.0 per cent), telecommunications (5.1 per
cent), and aerospace (3.7 per cent).
The vast expenditures on R&D are not surprising, given the uncertainty of
success of a new drug candidate. Only one of every 5000 products screened is
ultimately approved as a new medicine; the others drop out because of concerns
about safety, efficacy or profitability. But the most sobering statistic of all
is that because of the enormous costs of bringing a new drug to market, only
three in ten drugs that are approved and marketed ultimately produce
revenues that recoup their R&D costs.
This state of affairs encourages drug companies to focus increasingly on
financial blockbusters -- usually treatments for chronic conditions that affect
large populations -- and to neglect products with more modest prospects, no
matter how medically important or technically feasible they may be. For
example, although they are tremendously critical and cost-effective,
antibiotics and vaccines are out of favor.
The pharmaceutical industry has structural problems, to be sure. As Dr. Angell
points out, drug companies do develop too many "me-too" drugs that
differ little from earlier products, and spend disproportionately on marketing
and promoting them.
But in large part these strategies are the result of the industry's being the victims
of government policies, not, as Dr. Angell argues, their beneficiaries. In
spite of increasingly powerful and precise technologies for drug discovery,
purification and production, development expenses have soared: On average,
including both out-of-pocket expenses and opportunity costs, it now costs more
than $800 million to bring a new drug to market.
One important reason for these debilitating costs goes all but unmentioned in
Dr. Angell's account: The highly risk-averse FDA keeps raising the bar for
approval, especially for innovative, high-tech products and technologies.
Immunotherapy tailored to individual patients, human gene therapy, and
"biopharming" -- the production of drugs in gene-spliced crop plants
and animals -- have been hit especially hard. But Dr. Angell's prescription is
for regulators to become even tougher and less "accommodating" --
according to her, "there is now far too much emphasis on speed at the
FDA." But this would only push R&D costs higher and reduce further the
number of drugs approved.
Instead of Dr. Angell's snake oil, what we need is regulatory reform to lower
the costs and time of drug development. That would stimulate the formation of
new companies and enable them to pursue more drug candidates, including some
that are medically needed but offer only modest revenues.
As for the accusation that the industry has bought off the political process,
history argues otherwise. The companies have tended to defend the public policy
status quo instead of using their prodigious lobbying muscle for reform. They
squandered a stunning opportunity during the mid-1990's, for example, when
Congress undertook regulatory reform: The pharmaceutical and biotech industries
lobbied for, and got, the worthless, toothless FDA Modernization Act of 1997.
Having incorrectly diagnosed what ails the drug industry, it's hardly
surprising that Dr. Angell prescribes the wrong remedies. She calls, for
example, for regulators to require that new drugs be tested not against
placebos, but against other drugs for the same condition -- an inappropriate
and far higher standard. This change in policy would reduce both the overall
number of drugs approved and the availability of backup drugs -- for example,
for patients who might be allergic or otherwise intolerant to a first-line
drug, or who develop resistance to an antibiotic or anti-cancer treatment.
Moreover, this proposal fails to take into consideration that a drug initially
approved for one purpose often is subsequently found to have other important
uses; for example, preliminary studies suggest that the antidepressant Zoloft
may be an effective treatment for bulimia. This not uncommon situation argues
against Dr. Angell's proposal, which would lead to the initial approval of far
fewer drugs, and thereby reduce the likelihood that alternative applications
could be discovered later. It would be a profound disservice both to physicians
and patients.
Dr. Angell wants to end drug companies' "control [over] the clinical
testing of their own drugs," because "this practice biases the
research in favor of the sponsor's drug." Instead, she suggests the
creation of a federal Institute for Prescription Drug Trials within the NIH
"to administer clinical trials of prescription drugs" by
"contract[ing] with independent researchers in academic medical
centers." However, this function lies far outside the mainstream of the
NIH's current functions. What makes this proposal a particularly difficult pill
to swallow is that drug companies would no longer decide which products should
be developed: That responsibility would belong to federal bureaucrats, who
"might prioritize trials on the basis of unbiased expert advice."
How would we fund Dr. Angell's new multi-billion dollar bureaucratic behemoth?
Easy: Drug companies would support it, but "their contributions would not
be related to particular drugs."
Incensed at the "lust for profits" of the drug industry, and at the
supposed protections and subsidies afforded it by government, Dr. Angell feels
it should "be regarded much as a public utility," complete with price
controls. Is it possible that Dr. Angell does not understand that free markets
and competition discipline costs, stimulate innovation, and enhance the quality
of the product on offer? She is old enough, after all, to recall a time when
telephone service was regarded as a public utility: Phones had few features and
were connected to the wall by a cord, and rates were sky-high. Moreover, as
economist Arnold Kling has written, just because you run an industry as a
utility "does not mean that it will be regulated by a Platonic
philosopher-king who discerns the public interest. On the contrary, it means
that you take away the consumer sovereignty of the market and replace it with
the backroom deal-making of the lobbyist."
Dr. Angell's proposals to, in effect, nationalize the American system of drug
development reflect almost inconceivable naiveté. They are reminiscent of
economist Milton Friedman's example of a flawed syllogism: Capitalism has
worked everywhere it has been tried; socialism has failed everywhere it has
been tried; therefore, let us try socialism.
A spirited diatribe can educate and entertain, but in The Truth About the
Drug Companies, Dr. Angell does neither. Her diagnoses are wrong, and her
remedies -- which are reminiscent of the government controls and centralized
planning of the old Soviet Union -- are far
worse than the disease.
Henry Miller, a physician, is a fellow at the Hoover Institution and the
Competitive Enterprise Institute. He was an FDA official from 1979 to 1994.
TCS Daily
The Truth About Marcia Angell
By Henry I. Miller - September 1, 2004 12:00 AM
Categories:
Henry I. Miller








