[Ip-health] WSJ on PhRMA-supported patient group lobbying

[Mike Palmedo]

http://online.wsj.com/article/SB118426152232264867.html?mod=googlenews_wsj

PILL PUSH - Industry Fights Switch To Generics for Epilepsy
Big Drug Makers Help Patient Groups Lobby; More Attention to States

Wall Street Journal
By SARAH RUBENSTEIN
July 13, 2007;

In state legislatures across the country, the Epilepsy Foundation has
been campaigning for bills that would make it harder for pharmacists to
switch patients to inexpensive generic epilepsy pills. The effort is
getting behind-the-scenes support from drug companies -- a sign of how
the industry, long a potent lobbying force in Washington, is
increasingly looking to states to achieve its goals.

The foundation, a nonprofit group supported by the drug industry, says
switching to generics could cause dangerous seizures. The Food and Drug
Administration says it hasn't seen persuasive evidence for that, and it
believes each generic is equivalent to the brand-name drug it copies.

Four major brand-name drugs used for epilepsy are expected to lose
patent protection and face generic competition between next year and
2010. Those four drugs generated $5 billion in U.S. sales last year,
according to IMS Health, meaning the state legislation could have a
significant bottom-line impact. Some of the $5 billion figure reflects
sales of the drugs for other ailments.

Generic drugs are the centerpiece of efforts to tame growth in America's
prescription-drug bill, which topped $270 billion in 2006. When a doctor
writes a prescription for a brand-name drug, pharmacists are usually
permitted in most states to make an automatic switch to a generic judged
equivalent by the FDA.

The epilepsy legislation would carve out an exception to that rule, with
many of the bills requiring that doctors explicitly approve such a
switch. Tennessee has passed a weaker version that requires doctor
notification but not consent. Around 25 other states have considered
some form of restriction in the past year.

It isn't the only health issue where states have been the central
battleground. Earlier this year, Merck & Co. drew fire for lobbying
states to require that preteen girls receive its cervical-cancer vaccine
to attend school. Merck stopped its direct lobbying in February, but a
group of female state legislators that has received funding from the
drug maker continue to push for the laws.

States often move faster than Congress, says Jan Faiks, who runs state
policy for the Pharmaceutical Research and Manufacturers of America, or
PhRMA, the drug industry's trade group. State legislation can move "from
idea, to passage, to governor's signature in 90 days, sometimes faster
than that," she says. "So the action is in the states."

Campaign contributions to state candidates by pharmaceutical
manufacturers and their employees rose to about $8.8 million for 2006
from about $4.6 million for 2000, according to the National Institute on
Money in State Politics. Drug makers spent more than $44 million on
state lobbying in 2003 and 2004, the last years for which figures are
available, according to the Center for Public Integrity.

In state legislatures, as in Congress, the drug industry often enlists
nonprofit health and patient-advocacy groups to advance its agenda. In
the epilepsy case, the Epilepsy Foundation's state affiliates, rather
than the companies, are taking the most prominent part in the lobbying.

The foundation and its state affiliates receive funding from the
epilepsy-drug makers. GlaxoSmithKline PLC and UCB SA donated $500,000 to
$999,999 each in fiscal 2006 to the national foundation, according to
its annual report. Abbott Laboratories and a Johnson & Johnson unit each
contributed $100,000 to $499,999. Representatives of four drug companies
sit on the foundation's board, as does PhRMA chief Billy Tauzin.

The foundation and its affiliates had about $77 million in revenue in
2005, about $48 million of which came from state and federal grants.

The foundation says its diverse funding base shields it from undue
drug-company influence, and the industry executives on its board didn't
participate in discussions of the drug-switching issue. Foundation
leaders note that the state bills would generally require doctor
permission for several kinds of switches, including when a patient goes
from a generic to a brand.

"These are people's lives that we're talking about -- nothing about
stock options and stock value and how this would affect [companies']
bottom line. That would be insulting to us to have discussions like
that," says Sindi Rosales, the head of a foundation affiliate in Texas,
one of the states that weighed legislation this year. She says
pharmaceutical companies are "fabulous partners" and their help in
several areas "has been amazingly tremendous," but the companies leave
it to the foundation to call the shots.

For their part, company executives describe their lobbying role as
limited and say the bills were primarily an initiative of the
foundation, although they acknowledge in certain cases that company
officials have gotten directly involved. Executives say the aim of these
activities is to protect the health of patients. "Our issue is not
selfish toward our individual product," says Richard Denness, a vice
president at Belgium-based UCB. "It's a real concern in the minds of
prescribers.... All it takes in the scheme of things are one or two
patients to have a tragic event."

In the late 1990s, the national Epilepsy Foundation, based in Landover,
Md., raised concerns about anecdotal reports that some patients
experienced seizures and side effects after switching epilepsy drugs.
Some of the episodes involved patients who had been switched to a
generic from a branded drug. The foundation also worried about cases in
which patients were switched from one generic version of a drug to
another generic version of the same drug.

When the FDA approves generics, it requires manufacturers to show in
human studies that their copycat pills deliver a similar amount of
active ingredient to the bloodstream as the brand-name original.
However, the agency doesn't require exact equivalence. That would be an
impossible bar to clear, because there is always a slight variation in
the way people absorb drugs.

The foundation theorized that some generic pills had a meaningful
difference from the brands. This difference, it postulated, meant
patients were getting more or less of the drug in their blood, causing
some of them to have seizures or side effects. Foundation officials
floated the idea in a 1999 meeting with the FDA.

The FDA's response: "Show us the data," recalls Sandy Finucane, who
oversees state and federal policy for the foundation. The agency,
unpersuaded by what it saw, stood firm in its long-held position that
the difference was too small to have a tangible impact on patients.

Coming up with the kind of evidence the FDA sought would have required a
major clinical trial to demonstrate that the seizures were a direct
result of the switches, Ms. Finucane says. The foundation thought it
would be difficult to enroll patients for such a trial, and the costs
were prohibitive, she says. For years the foundation didn't push the
matter, beyond developing policy statements and encouraging patients and
doctors to report problems to the FDA.

In early 2006, the issue re-emerged as legislation requiring doctor
permission for switches was proposed in Illinois. That's the home state
of Abbott Laboratories, which makes Depakote, a leading epilepsy pill
that is expected to face generic competition next year. The bill passed,
but in watered-down form. An Epilepsy Foundation official in Illinois
says Abbott helped fund lobbying for stronger provisions that were
considered this year but didn't pass. Abbott said it supports some
foundation initiatives but declined to give specifics.

In May 2006, the national Epilepsy Foundation convened a committee of
medical experts to examine the question. The committee found a lack of
authoritative studies showing that such drug switches cause problems,
says its chairman, Steven Schachter, a Harvard Medical School
neurologist. Nonetheless, it recommended that doctors give explicit
approval for switches, citing anecdotal reports of seizures and noting
that such attacks can be serious.

Last fall, the American Academy of Neurology issued a statement making a
similar recommendation. The academy says it receives funding from drug
makers for educational programs but not for developing medical guidelines.

At a meeting last September, the national foundation told its local
affiliates that if they wanted to push for legislation regulating
switches, the foundation would provide model legislation and support,
Ms. Finucane says. It also told them to "maintain independence from any
company that's going to be interested in this issue," she adds. The
50-plus affiliates operate largely autonomously.

The sponsor of a bill in Georgia, state Rep. Charlice Byrd, says a UCB
official was the first person to raise the epilepsy-drug switching issue
with her. The Belgian company makes the epilepsy drug Keppra. Ms. Byrd
says she was sympathetic because her late mother had epilepsy.

Charlotte Thompson, who joined the foundation's Georgia affiliate as
executive director last September, says she became aware of the bill
after hearing about it from UCB. "When we realized [Rep. Byrd] was
introducing this and looked at it and studied what it was, then we
jumped on the bandwagon," Ms. Thompson says. Six lobbyists for three
companies joined a committee created by the Epilepsy Foundation to work
on the legislative process, she says.

Ms. Byrd says several pharmaceutical-company lobbyists offered their
support. Abbott lobbyist Guy Mosier "was extremely helpful working with
legislators to help them understand the importance and that this piece
of legislation was strictly for patient protection," Ms. Byrd says. Mr.
Mosier declined to comment.

Ms. Byrd introduced the bill in the Georgia House in January of this
year. At a Feb. 7 hearing of the House's health committee, Lasa Joiner,
executive director of the Georgia Psychiatric Physicians Association,
testified in support. Ms. Joiner was at the time also a Glaxo lobbyist,
which she didn't mention at the hearing. In an interview, she said she
didn't raise her tie to Glaxo because the company hadn't asked her to
lobby for the bill.

Two days later, epilepsy patients and parents of patients visited
lawmakers' offices to ask them to support the bill. The Epilepsy
Foundation's Ms. Thompson says drug-company lobbyists accompanied the
visitors.

Kimberly Oviedo says her 6-year-old daughter had seizures last year
after being switched to a generic version of the epilepsy drug Zonegran.
She says she supported the bill because she wouldn't "want any other
person to have to go through what we've been through with our kids." Ms.
Oviedo also has a son who suffers from epilepsy.

The bill passed the Georgia House in a 161-0 vote on Feb. 28, but it
stalled in the Senate after groups representing pharmacists and
generic-drug makers mounted heftier opposition to it in that chamber.
Pharmacies often earn bigger profit margins on generics than on branded
drugs.

Ms. Thompson says the foundation plans to meet with the Georgia Senate
leadership this summer to try to gather its support for next year.

In Texas, two local Epilepsy Foundation affiliates decided to approach
an Abbott official after they resolved to push for a bill, says Ms.
Rosales, the head of one of the affiliates. Abbott and other drug makers
helped fund the foundation's Texas lobbying, she says.

Ms. Rosales, whose daughter used to have seizures, says she felt deeply
about the bill but worried about being perceived as a "mouthpiece for
the pharmaceutical industry." She nonetheless hired Santos Alliances, a
firm that also represents PhRMA, as her affiliate's lobbyist. Ms.
Rosales says it's difficult to find a health-care lobbyist with no
drug-maker clients. Frank Santos, head of the lobbying firm, says PhRMA
was "absolutely 100% not involved" with the bill.

At a March hearing in the Texas Senate, Ron Hartmann, a lobbyist for a
generic-drug maker owned by Novartis AG of Switzerland, testified
against the bill. He said he suspected the bill was "less focused on the
citizens of Texas than on protecting the market share of a few
brand-name drugs that are scheduled to go off-patent in the next few years."

State Sen. Kyle Janek, the bill's sponsor, responded that Mr. Hartmann
had "impugned my motivations," and added that, if Mr. Hartmann would
"abstain from doing that," then he would abstain from calling Mr.
Hartmann a "high-priced shill." Mr. Hartmann apologized. In 2006, Sen.
Janek received about $19,000 in campaign contributions from drug makers.
He says he sponsored the bill because it was in the best interests of
patients.

The bill passed the state Senate in April, but failed to come up to a
vote in the House after debate in that chamber's health committee. Three
of the committee's members said in interviews later that they were
skeptical of the bill because they thought it was being pushed by drug
companies. Generic-drug makers and pharmacists lobbied heavily against
the bill.

Meanwhile, some doctors are pushing harder for a study that would settle
the matter. Michel Berg, a neurologist who is chairman of an American
Epilepsy Society task force examining the switching issue, has opened
discussions with the FDA about what kind of trial would be necessary.

For now, Gary Buehler, the director of the FDA's office of generic
drugs, says the agency is skeptical that the drug switches cause
seizures. "The only way you can somehow pin this down is to do a good
study," says Mr. Buehler.


--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu