Generics, Non-profits & Corporations

An excellent article which indicates how drug companies have used non-profit organizations as front to lobby for legislation in various states to stop generic drugs (epilepsy drugs in this example) on the grounds that generics can be harmful/not effective as compared to branded drugs, even though pro-industry FDA has denied any such claims and they have no proof. If you read through you will understand the various intricacies corporations go through and how blatantly it all takes place. Mind you this is from the pro-corporation Wall Street Journal, so tough to deny even for mainstream folks saying its hog-posh. Teaches you one clear lesson, dont buy what non-profits say without going into depth into their funding sources.
This is not first time non-profits are being used. Walmart funds some non-profits which have praised the "good" qualities of walmart and fought in lobbying for walmart. Exxon funds non-profits and uses them for different purposes. Corporate funding of non-profits ....
Just one of the several examples of corporations "work" ...


PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN
July 13, 2007; Page A1

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.
ON THE TABLE

[model legislation]
Model legislation the national Epilepsy Foundation has provided to state affiliates to address concerns about epilepsy-drug substitution:
A pharmacist may not interchange an anti-epileptic drug or formulation of an anti-epileptic drug, brand or generic, for the treatment of seizures (epilepsy) without prior notification of and the signed informed consent of such interchange from the prescribing physician and patient, or patient's parent, legal guardian or spouse of such person.
Source: Epilepsy Foundation

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.
[Top Treatments]

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.
[chart]

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.