Brushing off the risks inherent in drug reimportation schemes,
Minnesota Governor Tim Pawlenty has a standard retort: “Show me the
dead Canadians.”
There are now dead Canadians. The Royal Canadian Mounted Police
this month charged Abadir Nasr, former owner of King West
Pharmacy in Hamilton, Ontario, with selling counterfeit Norvasc.
Five people who filled their heart medication prescriptions at the
pharmacy died of heart attack or stroke. At press time yesterday
evening, Gov. Pawlenty’s office did not have a comment.
Amid the din for importing pharmaceuticals, politicians are
ignoring the plan’s legitimate health risks. Proponents smear the
drug industry and opponents fret about economic costs. But drug
reimportation’s real harm is that it would import foreign
regulatory standards and their burgeoning counterfeit drug
trade.
Two bills pending in the Senate by Sens. Byron Dorgan (D-N.D.)
and David Vitter (R-La.) would allow importation from Canada and
Europe, among others. And today the Senate votes on an agricultural
appropriations bill containing an amendment by Vitter* and Sen. Tom Coburn
(R-Okla.) that would bar the Food and Drug Administration from
preventing individuals from importing foreign meds. If the
amendment garners 60 votes or more, it will become a stand-alone bill with a fine chance of reaching
President Bush’s desk.
Economically, reimportation is a fool’s errand. Pharmaceutical
companies sell their products at market prices. Companies must
price their drugs so as to recoup research and development and
marketing costs (new drugs cost as much as $500
million to develop, so a retail price of $5 or $10 a pill isn’t
so steep) and bring profits back to their investors. If the
industry cannot charge Americans such prices, they’ll have less
incentive to develop new products.
While these drugs are less expensive in foreign markets, the
pharmaceutical industry accounts for these governments’ price
controls. As Sally Pipes points out in Miracle Cure: How to Solve America’s Health Care
Crisis and Why Canada Isn’t the Answer, the pharmaceutical
market is segmented by country. The industry can price its products
according to basic economics in the American marketplace, financing
overall production. “Drug companies can tolerate price controls in
developed countries like Canada as long as the prices cover
marginal costs, and the country represents a small share of the
market,” Pipes writes. If Americans were to import their drugs from
Canada at Canadian controlled prices, pharmaceutical companies
would probably stop selling to Canada. Drug importation is a
populist panacea.
YET IMPORTATION THREATENS AMERICAN health much more than it
threatens common sense. Experts convened on Capitol Hill Tuesday by
the Pacific Research Institute and the Center for Medicines in the
Public Interest detailed how foreign drug markets are compromised
by counterfeit medicines. Counterfeit medicines are those that have
been deliberately mislabeled: they could contain the wrong
ingredients, too many active ingredients, or too few active
ingredients. The danger to the patient is manifold.
These are the markets from which some politicians propose we
import. The World Health Organization estimates that 8 to 10
percent of pharmaceuticals sold worldwide are counterfeit. The
counterfeit market doesn’t stop at the European Union or Canadian
borders, writes Graham Satchwell, a British
counterfeiting investigations expert. The EU cannot track drug
shipments, which is a problem for an economic zone that internally
reimports (called “parallel trading”) over 140 million drug
packages a year. Some have estimated that 120 million counterfeit drugs are sold
in the U.K. alone. “Once you allow the importation of drugs from
Europe,” Satchwell told conference attendees Tuesday, “You allow
the importation of drugs from everywhere.”
And as interest in Canadian drugs has grown, so have reports of
online pharmacies shipping drugs not approved for the U.S. market.
In a test last year, the GAO found that “16 of 18 drugs it ordered from
Canadian pharmacies weren’t approved for sale in the U.S.” Canadian
officials admit that the online pharmaceutical market is highly
unregulated and difficult to track.
Though counterfeit drugs aren’t absent in the U.S., our market
cannot very well bear opening the floodgates. Carmen Catizone,
executive director of the National Association of the Boards of
Pharmacy, said Tuesday that given current strains on the FDA
regulatory scheme, “It’s amazing the system remains secure and
safe.” Drug reimportation “could be the straw that breaks the
camel’s back and compromises the U.S. distribution system,”
Catizone said.
Reimportation would expose the United States to the catastrophe
that counterfeit medicines have wrought in less developed
countries. The World Health Organization estimates that 25 percent of medicines traded in
less developed countries are counterfeit. Other statistics from the
developed world are startling: over 50% of antimalarials in
Southeast Asia are counterfeit; authorities believe a fake
meningitis vaccine is responsible for 2,500 deaths in Niger; and
the Chinese government, usually reticent about admitting failure,
estimates that counterfeit medicines cause 192,000 deaths a year in
China.
Drug reimportation is a sovereignty question. Americans would
surrender quality control and market forces to the countries from
which we import. Drug reimportation supporters don’t have the
chutzpah to impose price controls, so they import them. As Prof.
David Taylor of the London School of Pharmacy put it Tuesday, once
you import foreign drugs, “you’ve surrendered your own
government.”
But most importantly, this is a safety question. Will Americans
be more or less safe under drug reimportation? Politicians seem
unconcerned with such trivialities. Health policy consultant Mike
Tremblay succinctly formulated the issue Tuesday: “The consequences
of getting it wrong are dead people.” Will Gov. Pawlenty and Sens.
Vitter and Dorgan wait for American bodies before they address the
risks of importation?
*UPDATE (9.22.05. 10:40 a.m.): Sources on Capitol
Hill tell TAS that Sen. David Vitter last night chose not
to offer the drug reimportation amendment to the agriculture
appropriations bill. TAS is told Vitter was not confident
that he had the votes for passage. While the separate bills are
still options, their chances of seeing floor votes are
doubtful.
