[e-farmacos] El gobierno Bush intensifica sus relaciones con la industria

[e-farmacos@usa.healthnet.org]

E-farmacos: El gobierno Bush intensifica sus relaciones con la industria
-------------------------------------------------------------------------

[En la linea critica de otros articulos que hemos reproducido en
'e-farmacos', la edicion del dia 4 de noviembre del periodico New York
Times publicaba este articulo sobre el lobby de la industria
farmaceutica y sus estrechas relaciones con el gobierno del Presidente
Bush, especialmente tras los sucesos del 11 de septiembre y los ataques
bioterroristas. Esta estrecha colaboracion se suma a la magna aportacion
economica realizada por las companhias farmaceuticas durante la campanha
electoral del presidente republicano, y probablemente no sea tan
altruista como se quiere presentar por parte de la industria. El
articulo original lo ha difundido tambie la lista de discusion 'e-drug'
(gracias), AF] 
 
New York Times, November 4, 2001

A Muscular Lobby Tries to Shape Nation's Bioterror Plan
By Leslie Wayne and Melody Petersen

With anthrax spores turning up all over Washington, plenty of people are
heading out of town.

Not those in the drug industry.

Executives of the major pharmaceutical companies have been hopping
trains and planes to the nation's capital, where they are staging an
enormous lobbying campaign, at the highest levels of government, to help
shape the nation's bioterrorist plan - and beyond.

So far, they have had some remarkable victories. While the government
has struggled to make sure the nation will have enough drugs to treat
biological weapons that were largely hypothetical a few months ago, drug
companies have managed to stave off many actions that would harm them,
like violating patents or forcing them
to supply free drugs. 

As that success shows, the pharmaceutical lobby, which represents the
nation's biggest drug makers, from Eli Lilly to Pfizer to Merck, is both
large and politically adroit and, if anything, more sophisticated than
when it gained fame in the early 1990's for helping to defeat the
Clinton administration health plan.

It has more lobbyists than there are members of Congress - 625 who are
registered. It had a combined lobbying and campaign contribution budget
in 1999 and 2000 of $197 million, larger than any other industry. Now it
is harnessing those resources to influence major policy decisions being
made by the Bush administration that may well influence public health
issues and industry profitability for years to come - much to the dismay
of many consumer groups and others.

"When you've got this access to high places, it will encourage these
guys to coordinate instead of compete," said Jack Calfee, a health care
expert at the American Enterprise Institute, the conservative research
group. "It's more likely to forestall getting good products than to
encourage it."

Because of the anthrax scare, and all the attention given to Cipro, the
anti-anthrax drug of choice, that access has been enormous. In recent
weeks, the chief executives and other top executives of Merck,
Bristol-Myers Squibb, Bayer, Pfizer, Eli Lilly and Johnson & Johnson,
along with trade association officials, have been meeting regularly with
Bush cabinet members. On one occasion, with executives from other
industries, pharmaceutical executives met with President Bush in New
York to discuss the administration's response to terrorism. Drug company
executives have offered to send scores of industry scientists, now on
their payrolls, to work in government agencies in what the industry
calls a gift to the nation, but critics say it is both a conflict of
interest and a way for the industry to get a toehold in government.

In return, at these top-level meetings, industry executives and
lobbyists are seeking exemption from antitrust regulations, reduction of
the timetable for getting new drugs to market for treating the ills of
biological warfare, and immunity from lawsuits for any vaccines they
develop to combat bioterrorism. The administration, those in the meeting
say, has offered other help, asking the pharmaceutical executives to
identify the regulatory barriers they would like to see eliminated for
this fight.

Last Wednesday, for instance, a dozen industry lobbyists and executives,
among them Peter R. Dolan, chief executive of Bristol-Myers, and Raymond
V. Gilmartin, chief executive of Merck, met for an hour and a half in
the Roosevelt Room of the White House with Tom Ridge, the director of
homeland security. According to one person at the meeting, Mr. Ridge was
so impressed with what the industry executives said that he responded:
"I'm grateful for your offers of assistance. I accept." 

That , according to the meeting's participant, reflected "a true
partnership between the federal government and America's pharmaceutical
companies."

Industry executives say they are just trying to help. "We are part of
the nation's defense system," said Mr. Dolan, who has met with President
Bush in New York and with Tommy G. Thompson, the secretary of health and
human services, and Mr. Ridge in Washington. "As an industry, there is a
real opportunity for us to give our resources in a time of great need." 

But that partnership is troubling to some industry watchdog groups.

They say the cozy relationship threatens to compromise regulatory
standards on new applications of medicines at a time when millions of
Americans may be seeking new drugs and vaccines. They worry that the
industry's efforts to present its proposals as patriotic gestures mask
an effort to increase its power in Washington and to improve its image
while still protecting its financial interests. Critics also say
consumer groups and executives from generic drug companies, which make
cheaper copies of well-known drugs, have been conspicuously absent from
any administration meetings.

"I am concerned that the industry is trying to subvert the normal
regulatory process," said Dr. Sidney Wolfe, director of the health
research group of Public Citizen, a Washington research organization.
"These meetings have no transparency, no openness nor any involvement of
the public. It's a dangerous precedent."

The pharmaceutical industry, of course, has not always had its way. Some
of its efforts to speed federal drug approval have failed. Federal
regulators are actively investigating several companies' attempts to
keep generic drugs off the market and are taking a harsh look at some
marketing practices.

There is no lobby in Washington as large, as powerful or as
well-financed as the pharmaceutical lobby. Battle-honed over a number of
health care initiatives that began with the creation of the Medicare
program in the 1960's, the industry spent $177 million on lobbying in
1999 and 2000 - a good $50 million more than its
nearest rivals, the insurance and telecommunications industries.

Thanks to Washington's well-oiled revolving door between government and
business, the industry is able to claim friends in especially high
places. Defense Secretary Donald Rumsfeld is the former chief executive
of the drug maker G. D. Searle, for example, and Mitchell E. Daniels
Jr., the White House budget director, is a
former Eli Lilly executive.

Even more important, more than half the drug industry's 625 registered
lobbyists are either former members of Congress or former Congressional
staff members and government employees, according to a report from
Public Citizen. Former members of Congress who now work for the industry
include Beryl F. Anthony Jr., Birch Bayh, Dennis DeConcini, Vic Fazio,
Norman F. Lent, Robert L. Livingston, Bill Paxon, Robert S. Walker and
Vin Weber.
While in Congress, many of them led key legislative committees, and they
still have close ties to those now in power.

Along the city's fabled K Street corridor, 134 lobbying firms are on the
industry's payroll. One company, Bristol-Myers Squibb, has hired 15
lobbying firms with 57 lobbyists, including such superstars as Haley
Barbour, a former chairman of the Republican National Committee, and
Thomas H. Boggs Jr., the city's legendary
Democratic lobbyist and son of the former Louisiana representative Lindy
Boggs (and the late Hale Boggs, a former Democratic House majority
leader). 

The industry has also hired such up-and-coming lobbying rainmakers as
Deborah Steelman, a powerful Republican insider, and Anthony Podesta,
brother of President Bill Clinton's former chief of staff.

On top of that, the industry makes generous campaign contributions -
giving much more to Republican politicians than to Democrats. Of the $26
million that the industry donated in the presidential election cycle,
nearly 70 percent went to Republican candidates. Last January, the
industry wrote a $625,000 check -
one of the biggest - to the Bush-Cheney inaugural committee.

One of the industry's staunchest critics, James Love, the director of
the Consumer Project on Technology, who works to get low-priced AIDS
drugs to poor countries, called the industry's drive for government
contracts for medicines against bioterrorism "a feeding frenzy."

"They are putting together another gravy train to cash in on some big
government contracts," Mr. Love said.

With Americans spending more than $100 billion on drugs last year -
double the amount of 1990 - and with public pressure increasing for
pharmaceutical companies to lower their prices, the companies concluded
quickly that they had to become an active participant in the resolution
of the nation's crisis. Executives have gone  to great lengths to say
that they are not going to profit from it. They point to the fact that
Bayer, under pressure from the government, reduced the price for
government purchases of its anti-anthrax antibiotic, Cipro.

At every opportunity, they have also noted that they plan to give away
additional drugs and vaccines to the government fight bioterrorism -
albeit with some important strings attached. The medications would be
made available only if the government agreed to speed the process that
would allow existing drugs to treat 
anthrax and only if there was a national emergency.

"It's very unusual for our industry to get a large number of chief
executives to come to Washington on short notice," said Alan F. Holmer,
chief executive of Pharmaceutical Research and Manufacturers of
American, the industry's trade group. "But it reflects our overwhelming
desire to do whatever we can to address these issues. This is not about
profits. It is not about patents. It is about making sure we have an
adequate supply of medicines available to the American people."

Not so fast, critics say. They say the drug industry is trying to
stockpile good will at a time when it badly needs to improve its image
in Washington. For years, the industry has been roundly criticized for
putting profits ahead of people when, for example, it has blocked or
stalled the production of cheaper, generic drugs.
Criticism comes most loudly from senior citizens and health care
providers.

The drug industry needs this political capital both now and the future -
especially when it comes to patents. For the industry, the protection of
patents - which give companies monopoly control over the drugs they
bring to market for a number of years - is basic to their existence. For
them, any threats to that protection, even at a time of national crisis,
is a clarion call to action.

"This is a huge issue to them," said William Nixon, chief executive of
the Generic Pharmaceutical Association, which battles the large drug
companies with a budget of about $2 million a year. "They will do
everything in their power to maintain their monopoly. There is no
question of that. And that's what made Bayer and Cipro so 
important to them. It could be perceived by them as the crack in the
dike that they have been trying to put a finger in. They didn't want
this to escalate."

Companies are fighting so hard to protect their patent rights in part
because they have so few drugs with large potential that will move from
development to the market over the next several years. 

By 2011, brand-name drugs with more than $40 billion in annual sales are
expected to go off patent; they can then be sold by generic drug makers
at prices of, say, 70 percent less. Last year, the Food and Drug
Administration approved just 27 new drugs, down from 35 the year before
and about half the number approved 
in 1996. To prevent huge drops in revenue, drug makers need to hold on
to their patent protections for as long as possible - or even extend
them further.

The industry is also hoping that its effort will build political capital
for legislation pending before Congress and later as well. At the
moment, industry lobbyists, among them Mr. Boggs, the Democrat, and Mr.
Barbour, the Republican, are swarming through the halls of Congress
because the House is about to consider a  Senate-passed bill to extend
the industry's monopoly patents by six months on many existing drugs - a
measure that could reap billions for the industry but cost consumers.
Also on the horizon are trade talks in 
Qatar that will deal with patent rights and a battle over prescription
drug benefits in Medicare.

"The industry has been under the gun and losing the public relations
war," said Ira S. Loss, a drug industry analyst for Washington Analysis,
which provides research for institutional investors. "The drug industry
has been pointed to as a major reason for the rise in health care costs.
They are trying to position themselves  for the future and to be able to
say: `We are not the bad guys. When the country was in a crisis, we
stepped in and were willing to donate our products.' "

But Mr. Loss says, there is less than meets the eye to the industry's
offer of free medications. Johnson & Johnson, GlaxoSmithKline, Bristol-
Myers Squibb and Abbott Laboratories have all made offers of free
medications to fight bioterrorism - should the government speed these
drugs through the approval process.

"It's a very contingent offer," Mr. Loss said. "If they get the approval
and if there is a national crisis, they will provide it for nothing. You
have to have two ifs for it to work."

And there may have been another motive for the corporate offers. Drug
makers depend on patents to help them recoup their research and testing
costs, but once those costs are recovered, the high prices they charge
for patented drugs give them operating margins that are among the
highest in corporate America. 

Several of the offers of assistance came a day or two after Mr.
Thompson, the health secretary, threatened to seek Congressional
approval to break Bayer's patent for the anthrax drug Cipro if Bayer did
not lower its price for the drug. A few days earlier in Canada, the
government had momentarily overridden Bayer's patent by
ordering a generic version of Cipro from another company.

The drug companies say their offers of free drugs had no connection to
Mr. Thompson's comments on Cipro's patent. "We only wanted to be as
helpful as we can," said Jeffrey J. Leebaw, a spokesman for Johnson &
Johnson.

In the end, Bayer backed down and agreed to reduce the price of Cipro
tablets to the government to 95 cents a pill from $1.77 for the first
100 million, to 85 cents for the second 100 million and to 75 cents
after that. It also agreed to increase production. Still, while these
price reductions will dent Bayer's profits, they  pale next to the $800
million the company could have lost, according to analyst estimates, if
the Cipro patent had been overridden. Sales of Cipro, Bayer's
best-selling prescription drug, were $1.6 billion last year out of total
pharmaceutical sales of $5.8 billion for the company, which is based in
Germany. Stewart Adkins, a Lehman Brothers analyst in London, said the
cut in price for Cipro would reduce Bayer's profit margin on the drug to
65 percent from 95 percent.

"Bayer will still be doing O.K. on it," Mr. Adkins said. "If Bayer lost
the patent protection and the drug could be sold in the U.S. at generic
prices, it would have been devastating for the company." In the last few
days, as Congress has debated a patents measure, the industry has been
pulling out the stops to renew a law  that provides the pharmaceutical
industry with a six-month extension on patents in return for the drug
makers' agreement to do more testing of drugs for pediatric use.

Consumer groups say the bill would require the drug companies to do
little new research but would cost consumers $14 billion over what
generic equivalents would cost. On Cipro alone, for instance, Public
Citizen, the consumer group, estimates that Bayer would get an
additional $357 million in business that it could have otherwise lost to
cheaper generic drugs.

Fighting the hardest is Bristol-Myers, which is also seeking a
three-year extension on the use of Glucophage, a diabetes medicine,
based on studies of the drugs on children. Analysts estimate that the
company could reap an additional $1 billion in sales for every six
months the patent is extended. 

Eli Lilly, meanwhile, is lobbying Congress to overturn guidelines that
limit the use of its antipsychotic drug in Veterans Administration
hospitals - over the strong objections of some government doctors in
those hospitals. They contend that it would be a "dangerous precedent"
for Congress to start telling them which drugs to prescribe.

"This is a great time to buy some good will," said Jake Hansen, a
lobbyist for Barr Laboratories, which wants to make a generic version of
Glucophage, the Bristol-Myers diabetic drug. Under "normal times," Mr.
Hansen said, "the press would be having a field day" over the patent-
extension issue now in play.

But, with the attention on anthrax, big pharmaceutical companies "know
they are not under as much scrutiny," he said, adding "and they are
taking advantage of that." 


[NOTA: Mensaje sin acentos ni caracteres especiales.]
-
Envíe el correo para la conferencia de `e-farmacos' a:
e-farmacos@usa.healthnet.org
Envíe las peticiones administrativas a:
majordomo@usa.healthnet.org
Para la ayuda adicional, envíe el correo a:
owner-e-farmacos@usa.healthnet.org