Nation Topics - Health and Disease | The Nation

If politics got real...the debate over costly prescription drugs would turn to more fundamental solutions like breaking up the pharmaceutical industry's patent monopolies, which generate soaring drug prices, and rewarding consumers for the billions of tax dollars spent to develop new medicines. As a business proposition, that sounds radical, but it would actually eliminate outrageous profit-skimming at taxpayers' expense and liberate lifesaving medicines from inflated prices so millions of people worldwide could afford the health benefits.

At present, the government picks up the bill for nearly all basic research and development, mainly through the National Institutes of Health. Then private industry spends about $25 billion a year on more R&D--essentially taking NIH discoveries the rest of the way to market. The companies mostly do the clinical testing of new compounds for safety and effectiveness, then win regulatory approval for the new applications. This is one instance where a bigger role for government, by taking charge of the scandalous pricing system, could produce vast savings for the public--as much as $50 billion to $75 billion a year.

The National Institutes of Health and independent scientists working with NIH grants generally do the hard part and take the biggest risks, yet there is no system for sharing the drug companies' subsequent profits with the public treasury or for setting moderate prices that don't gouge consumers. Instead, the drug industry reaps revenues of $106 billion a year, claiming that it needs its extraordinary profit levels in order to invest heavily in research. The companies are granted exclusive patents on new products for seventeen years (or longer if drug-company lobbyists persuade Congress to extend them). Meanwhile, the manufacturers collect royalties (and less profit) on the very same drugs under licensing agreements with Europe, Canada and other advanced nations where the governments do impose price limits. Thus, Americans pay the inflated prices for new medicines their own tax dollars helped to discover--while foreign consumers get the break.

Years ago, although reform was mandated by law, NIH abandoned its efforts to work out a system for moderating US drug prices--mainly because the industry refused to cooperate and had the muscle in Congress to get away with it. Now that soaring prices have inflamed public opinion again, Dean Baker of the Center for Economic and Policy Research proposes a more radical solution. NIH should be given control over all drug-research policy, Baker suggests, and Congress should put up public money to cover the industry's spending (probably less than $25 billion because marketing costs get mixed into the research budgets as well as money spent to develop copycat drugs, which are medically unimportant). The exclusive patent system would be phased out, perhaps starting with cancer drugs and other desperately needed medicines whose prices are too high for poor nations to afford. For $25 billion or less in new public spending, brand-name drugs would largely disappear, but, Baker estimates, prescription costs for Americans would shrink by as much as 75 percent overall.

A less drastic solution, suggested by James Love of Ralph Nader's Consumer Project on Technology, would limit use of exclusive patent rights and, if needed, compel drug-makers to grant royalty licenses to other US companies to make and sell the same medicines, thus fostering price competition. Competing companies would be required to contribute a minimum percentage of revenues to R&D to maintain research spending levels. The government could also require companies to help fund government or university research.

The prescription-drug debate of Election 2000 is a long way from either of these visions for reform, but events may lead the public to take them seriously. Drug prices are inflating enormously. If Congress fails to make it legal, the bootlegging of cheaper medicines from Canada and other countries where the prices are controlled is bound to escalate, and the present system might break down from its own lopsided design. As a matter of public values, the discovery of new health-enhancing medicines ought to be shared as widely--and inexpensively--as possible, especially since public money helped pave the way to these discoveries. Jonas Salk never sought to patent his polio vaccine. He thought his reward was knowing how greatly his work had advanced all of humanity.

It took twelve years for the FDA to approve mifepristone--also known as
RU-486--and most of that time had less to do with medicine than with the
politics of abortion. Still, the late-September decision was a
tremendous victory for American women. In approving RU-486, the FDA
showed that science and good sense can still carry the day, even in an
election year.

The long delay may even backfire against the drug's opponents. In 1988,
when mifepristone was legalized in France, it was a medical novelty as
well as a political flashpoint. Today, it's been accepted in thirteen
countries, including most of Western Europe; it's been taken by more
than a half-million women and studied, it sometimes seems, by almost as
many researchers. By the end of the approval process, the important
medical professional organizations--the AMA, the American Medical
Women's Association, the American College of Obstetricians and
Gynecologists--had given mifepristone their blessing; impressive
percentages of Ob-Gyns and family practitioners said they would consider
prescribing it; thousands of US women had taken it in clinical trials
and given it high marks, with 97 percent in one study saying they would
recommend it to a friend. Against this background of information and
experience, the antichoicers' attempt to raise fears about the drug's
safety sounds desperate and insincere.

In a normal country, RU-486 would simply be another abortion method, its
use a matter of personal preference (in France it's the choice of 20
percent of women who have abortions, while in Britain only 6 percent opt
for it). But in the United States, where abortion clinics are besieged
by fanatics and providers wear bulletproof vests, mifepristone's main
significance lies in its potential to widen access to abortion,
especially in those 86 percent of US counties that possess no abortion
clinic, by making it private--doctors unable or unwilling to perform
surgical abortions could prescribe it, and women could take it at home.

It is unlikely, however, that Mifeprex, as the drug will be known when
it comes on the market, will prove to be the magic bullet that ends the
war on abortion by depriving antichoice activists of identifiable
targets. The nation has been retreating from Roe v. Wade for a
quarter-century, and a good portion of the patchwork of state and local
regulations intended to discourage surgical abortion will apply to
Mifeprex as well: parental notification and consent laws (thirty-two
states), waiting periods (nineteen states), biased counseling and
cumbersome reporting and zoning requirements. States in which
antichoicers control the legislatures will surely rush to encumber
Mifeprex with hassles, and small-town and rural physicians in particular
may find it hard to prescribe Mifeprex without alerting antichoice
activists. Doctors are a cautious bunch, and the anticipated flood of
new providers may turn out to be a trickle, at least at first. Abortion
rights activists should also brace themselves for a backlash from their
hard-core foes: Just after the FDA's decision was announced, a Catholic
priest crashed his car into an Illinois abortion clinic and hacked at
the building with an ax.

But in the long run, Mifeprex will make abortion more acceptable. In
poll after poll Americans have said that when it comes to terminating a
pregnancy, the earlier the better. Mifeprex, which has been approved for
the first forty-nine days after a woman's last menstrual period--when
the embryo's size varies from a pencil point to a grain of rice--may
well prove not to arouse the same kinds of anxieties and moral qualms as
surgical abortion. Then, too, Americans are used to taking pills. That,
of course, is what the antichoicers are afraid of.

For more than half a century, the US government has maintained a hard line on marijuana, denying that the plant has any medical value at all.

Neil Shulman, MD, first started seeing patients at Grady in 1969.
For more information or to help, contact medcrisis@netscape.net.

Emergency contraception has the potential to revolutionize women's relationship to sex and birth control.