[Mb-civic] Drug Firms ?Gouge? Consumers After Taking Taxpayer Handouts
ean at sbcglobal.net
ean at sbcglobal.net
Mon Apr 17 21:24:43 PDT 2006
http://newstandardnews.net/content/index.cfm/items/3059
Drug Firms Gouge Consumers After Taking Taxpayer
Handouts
by Catherine Komp
Thanks to huge government grants offered to pharma companies
that turn around and make gigantic profits off the drugs they
create, Americans are paying twice for many of the drugs on
which they depend.
Apr. 14 In response to a major pharmaceutical company's
announcement of skyrocketing profits and its plans to expand the
market for an expensive cancer treatment, patient- and consumer-
rights advocates are demanding that the government step in and stop
corporate "price gouging."
Consumers, such critics say, are paying twice first, through federal
grants to pharmaceutical companies to develop the drugs and again at
the drug store.
On Tuesday, the global biotechnology company Genentech reported
that the company's total product sales for the first quarter of 2006
increased 39 percent, to $1.64 billion, while sales of their colon-cancer
drug Avastin increased 96 percent, raking in $398 million. The same
day, Genentech also announced it was seeking approval from the
Food and Drug Administration to expand use of Avastin to treat lung
and breast cancer.
Currently, colorectal cancer patients pay about $46,640 to prolong their
lives through a ten-month treatment regimen of Avastin. According to
the company's website, Genentech has not decided whether it will
change Avastin's price if it receives the requested FDA approval, but
the company says lung and breast cancer patients would need a
dosage twice as high.
"It's immoral," said Sharon Treat, executive director of the non-profit
National Legislative Association on Prescription Drug Prices (NLARX),
referring to the price tag of Avastin. "There's no other source for this
drug," Treat told The NewStandard. "It's a monopoly market and you
have very sick people who can't afford to buy it now, and it just seems
completely wrong." NLARX is a group funded and directed by
lawmakers who seek to reduce prescription drug prices.
Genentech spokesperson Kristina Becker told TNS that the company
takes access to their drugs "very seriously." Beck said the company
provides free drugs to some people who do not have insurance and
meet eligibility requirements, including an annual income cap of
$75,000.
Jerry Flanagan, healthcare policy director with The Foundation for
Taxpayer and Consumer Rights (FTCR), a nonprofit consumer
watchdog group, said the development of life-saving drugs like Avastin
through federal dollars strengthens the case for government regulation
of drug prices.
"It's a basic issue of fairness," Flanagan said. "The federal government
involvement in Avastin has been similar to the federal government's
involvement in all prescription drugs, in that taxpayer dollars have been
used through the National Institute of Health to fund research and
development of pharmaceuticals."
In its analysis of National Institute of Health information, the
Foundation discovered that the federal government funded at least 100
clinical trials of Avastin. FTCR filed a request under the Freedom of
Information Act for documents containing the exact cost and budget of
each trial. The group estimates that about 44 percent of health
research in the United States is funded by federal grants.
Under a federal intellectual-property-rights law known as the Bayh-
Dole Act of 1980, federal agencies have the regulatory authority to
enforce reasonable pricing of patented drugs developed with the aid of
federal funding. However, Flanagan charged, the law is never enforced
due to the political leverage of pharmaceutical companies in
Washington.
A 2005 study by the Center for Public Integrity (CPI), a federal
watchdog organization, found that the pharmaceutical and health-
product industries spent $87 million on campaign contributions to
federal candidates between 1998 and 2005. It also found that one-third
of the industry's federal lobbyists were former federal officials.
"It's that kind of political power in Congress and at the regulatory level
in the Bush administration that has kept the regulators away from
enforcing these standards," Flanagan said. "There isn't the political will
in Congress to stand up to the drug companies and enforce rules that
require the drugs to be priced fairly. And that's not only a problem with
Avastin; it's a problem across the board."
Another obstacle to government enforcement of price caps could be
weaknesses in the law itself. Michael Davis, a professor of law at
Cleveland State University who has researched drug-price controls
under Bayh-Dole, said that regulation is triggered only when federal
funding has led to the actual invention of a product. In cases when
federal funding covers only testing and clinical trials after a product is
invented, he said, "it's very unlikely that you could make an argument
that the Bayh-Doyle Act applies."
At the state level, however, lawmakers are attempting to tackle the
issue of excessively expensive prescription drugs. The National
Conference of State Legislators reported that as of December 2005, at
least 144 bills in 44 states were passed addressing prescription-drug
access, affordability and regulation.
But like federal officials, state lawmakers are also not immune to
campaign-finance pressures. A CPI report released last week found
that the pharmaceutical industry spent more than $44 million on
lobbying state governments in 2003 and 2004.
In Washington, DC, city council members unanimously approved the
Prescription Drug Excessive Pricing Act of 2005, which would let
consumers sue pharmaceutical companies if the price of a drug is
more than 30 percent higher in the local market than in countries with
comparable income levels, like Canada, Germany or the United
Kingdom. Following lawsuits filed by drug-industry trade groups, a
federal judge ruled last December that the law was unconstitutional
because it violated laws governing interstate commerce and federal
patents. The city is appealing that ruling.
In Wyoming and Wisconsin, lawmakers have passed bills establishing
"drug repositories," which pool unused drugs donated by doctors,
patients and families, and then reissue them to low-income patients.
Other states, including Washington, Ohio, and Montana, have passed
laws authorizing bulk-purchasing programs, in which the state
negotiates drug discounts for local governments, private entities, labor
unions and uninsured individuals.
But James Love, director of the Consumer Project on Technology
(CPT), an international intellectual-property and health policy
organization, said that it is difficult for the government to negotiate
prices after a drug proven to be beneficial establishes its value on the
market.
"It's a very awkward conversation," said Love. "Basically, you're saying,
'How much money is the government going to pony up to keep this
person alive for a couple of months? What's that person worth?'"
Love's organization advocates more substantial changes in drug
licensing, including eliminating exclusive patent rights and instead
creating government-sponsored incentives for companies to develop
beneficial drugs.
Last January, Representative Bernie Sanders (I-VT) proposed
legislation to provide such incentives with the Medical Innovation Prize
Fund Act.
The bill would have established a fund to reward drug developers
based on the benefits of new treatments, while at the same time
requiring that FDA-approved products automatically be open to generic
production. But with no cosponsors, the bill died in committee in March
2005.
Flanagan of the FTCR said recent examples of "obscene" price-
gouging by drug companies are strengthening public campaigns to
stop the practice. In light of the failure of federal regulators to enforce
provisions of the Bayh-Doyle Act, he added, lawsuits could be the most
effective way to curb the ballooning prices of prescription drugs.
"When taxpayers contribute hundreds of millions of dollars to develop
a drug," said Flanagan, "that investment should be reflected in fair
pricing. [If] we're going to socialize the cost of developing these drugs,
we should also make sure there's a social benefit in that taxpayer
investment."
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