[e-farmacos] USA Today: Cipro y como el mercado farmaceutico se protege

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E-farmacos: USA Today: Cipro y como el mercado farmaceutico se protege
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[HH, moderador de la lista de discusion 'e-drug' (gracias) ha colgado
este mensaje que conmtiene un articulo aparecido en USA Today. Lo
reproducimos en la lista de discuion e-farmacos por si os interesa, AF]

http://cgi.usatoday.com/usatonline/20011029/3574904s.htm

Cipro saga exposes how drugmakers protect profits  
USA Today, October 29, 2001

With the anthrax attacks rocketing demand for the antibiotic Cipro, its
sole certified supplier, Bayer, agreed last week to sell 100 million
doses of the drug to the federal government at a hefty 46% discount.
That's good news for the government, which will save $82 million on the
Cipro emergency stockpiles it holds to treat
anthrax.

But the deal's not as good for the public, whose Cipro supplies weren't
part of the negotiated discount. And it raises troubling questions about
whether any discount would have been necessary if Bayer hadn't paid off
a potential competitor years ago to keep it from introducing a cheaper
generic version of the drug. 

In 1997, Bayer persuaded generic-drug maker Barr Laboratories to drop a
legal challenge to Bayer's patent on Cipro by agreeing to pay Barr about
$28 million a year until the patent expires in 2003. 

To most people, that sounds suspiciously like a payoff to avoid
competition, especially considering that drug prices typically drop 25%
the first year a brand-name prescription gains generic competitors. And,
indeed, the Federal Trade Commission (FTC) is looking at the 1997 deal
to determine whether it violates antitrust laws.

Legal or not, the practice is relatively common. In fact, it's just one
of many that drug companies use to prolong the lucrative patent
protection afforded brand-name drugs.

In most cases, that means consumers end up paying far more for
brand-name drugs far longer than the patent laws ever intended. With
roughly $20 billion worth of prescription drugs closing in on the end of
their normal patent lives, the potential costs are enormous.

As the Cipro example shows, the practices also can have potential public
health implications at a time of national crisis. Until Oct. 18, Cipro
was the only drug federally approved to treat deadly inhalation anthrax,
which meant that the public had been dependent on a single supplier for
treatment.


Patent abuses
Patents aren't supposed to work this way. In fact, they're designed as a
means to encourage innovation. In exchange for substantial investment
costs, companies are guaranteed a monopoly on that innovation for a
fixed amount of time. 

But drug companies have perverted the patent system in an effort to
prolong the guaranteed profits from their monopoly drugs. 

In 1998, for example, Abbott Laboratories paid generic maker Geneva
Pharmaceuticals $4.5 million a month to drop its patent challenge to a
hypertension drug. All Geneva had to do was agree not to compete. Geneva
held to the bargain, despite favorable court rulings on its challenge.
The cost to consumers from lost competition was $100 million a year.
After the FTC filed a complaint about the arrangement, the companies
finally agreed  to abandon it.

That's just one of several tricks used to keep low-cost generics off the
market. Among the others:

* "Citizen petitions." Under the law, anyone has the right to challenge
generic competition for a drug, but such petitions are often submitted
not by the public but by the patent-holding drug firms themselves. Filed
just before a patent is due to expire, the petition triggers a Food and
Drug Administration (FDA) review. The 
petitions almost never succeed, but until the review is finished,
generics can't come in and compete.

* Last-minute patents. Another trick is for the drug company to file an
entirely new patent on a drug just before a generic is about to be
approved. Under law, that triggers a 30-month delay, while disputes over
the new patent are settled. Bristol-Myers Squibb, for instance, won a
new patent on its antidepressant BuSpar in 2000, the day before generics
were to start shipping, claiming control over an ingredient created as
the drug is digested.

* Lobbying. When all else fails, drug firms have tried, usually
unsuccessfully, to convince lawmakers to grant patent extensions.
Schering-Plough has been trying for years to get Congress to approve an
extension on its big-selling allergy drug, Claritin.  

A new effort
If those weren't enough, a new tactic is being tested. Under current
law, a drugmaker gets a half-year patent extension for testing an
existing drug on children. Another law gives drugmakers 3 years of
exclusive rights for FDA-approved label changes. According to generic
makers, Bristol-Myers is trying to combine the two by
changing the label on its diabetes drug Glucophage to reflect pediatric
study results. If successful, it would pave the way for an easy 3 1/2
years of extra monopoly profits.

Drug-industry-patent abuses have become so pervasive that the FTC has
embarked on a broad investigation of them. Even lawmakers are taking
notice: Congress has at least two bills that would rein in some of the
worst abuses; the Senate passed its bill earlier this month.

Trying to squeeze out extra profits is not a surprising business tactic.
Doing so by abusing the patent system, however, is an affront to
consumers who pay the higher bills, and to the public, which could
suffer the consequences in a public health crisis.Today's debate: Drug
prices Consumers are regularly cheated
on patented, big-name drugs.

[NOTA: Mensaje sin acentos ni caracteres especiales.]
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