Friday, July 13, 2007

Advocacy in Whose Interest? - The Pharmaceutical Industry, the Epilepsy Foundation, and Generic Anti-Epileptic Prescribing

Just in time for another lazy summer weekend comes this article from the Wall Street Journal about another instance of cozy ties between the pharmaceutical industry and a disease-specific not-for-profit organization. (We posted about another such instance here.) The article's focus is how the Epilepsy Foundation has been campaigning against generic anti-epileptic drugs on a state level, while accepting significant funding from and leadership by pharmaceutical companies that make name brand anti-epileptics. First, the background,

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.

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.

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.

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.

In early 2006, the issue re-emerged as legislation requiring doctor permission for switches was proposed in Illinois.

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.

Now, about those ties among the foundation and pharmaceutical companies.

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 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.

Here we go again. We have noted before that conflicts of interest may not consciously affect human decision making, and how people affected by conflicts may be genuinely indignant when confronted with suggestions that the conflicts consciously influenced their decision making. But, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult" (see post here).

However, there is ample evidence that conflicts may affect how people think and what they do. Try a thought experiment. If you knew that your organization were getting a large amount of money from donor x, would you be more likely to take a position that directly goes against the interests of donor x, or the opposite?

In any case, this case appears to be yet another example of stealth health policy advocacy or stealth lobbying, and one that may succeed in keeping the costs of drugs rising ever higher.

See Pharmalot's related post here, and the Wall Street Journal's Health Blog's here.


Anonymous said...

Val Jones has a post concerning current comments on blogs by those who have a connection to the drug industry. An example is "The FDA is holding back important medications for .... reasons." She list a number of essentially sales pitches designed to support the pharma's position that branded drugs are the only legitimate choice for medication. This can also be accessed through Grand Rounds 3:42 Aetiology.

What this brings to mind is a class I had as an undergraduate taught by the sales manager of a drug wholesaler. One of the major points of the class was that a salesman, at that moment in time, believes what they are saying, no matter how outrageous. They will not acknowledge an opposing view. Today, there are no more drug ads, only educational information is being distributed.

With $270B spent on drugs in 2006 we need to look for any savings available in the area. Drug companies, and their lobbyist, do not view their work as a conflict, but as assuring the health of the country. Anecdotal evidence is certainly good enough to stop the use of generics, no data necessary. Trust us, we believe what we are saying.

We need to be aware that this tactic is not unique to this organization or this topic. This will be the blueprint for pharma's efforts in the future. The article makes it very clear that state legislatures will be the new battleground for reform and pharma does not intend to loose.

Steve Lucas

Anonymous said...

Here in Australia the big pharmas don’t have anywhere near the same power as the US. Therefore they don’t spend significant amounts of money on supporting advocacy groups, hopefully that might change your opinion of their indepedence.
However, we do have a generics issue because our Pharmaceutical Benefits Scheme (Govt funded) are always trying to reduce costs. We know that changing AEDs without proper supervision & management does lead to increased seizures (recent client survey not a clincial study). We also know that SUDEP (Sudden Unexplained Death in Epilepsy) has a strong correlation with break out seizures. Our arguement is for narrow therapuetic index drugs, you SHOULD stick with what you have been taking - whether that is a brand or generic. Any change either way should be in a closely supervised situation by the approriate specialists.
After all this is not an arguement in semantics or politics, it is about people and if we don’t manage it properly then at worst people will die, lose driver’s licences, possibly jobs or at best have their lives severley disrupted.

Anonymous said...

As an epilepsy patient, I know first hand that changes from brand to generics can have devastating effects. I am currently on the Epilpsy Foundation forum website speaking with others having very similar issues. Now while I think there is Foundation and Pharma collusion I do have to say that the FDA's requirements to meet generic standards only are not the same standards for specific AED's. WHile this results in higher costs, its a damn sight better than having seizures or toxic side effects because of cheaper excipients used in the process of making the medication. 10% of the medication is used in the pill or tablet while excipients make up 90%, and excipients are not regulated. Besides cost control, quality of life must be taken into account.

Anonymous said...

First of all, the Epilepsy Foundation is against switching without informing the patient and/or physican, not angainst generics. Generics are great and offer cost savings for epilepsy patients like me. The issue is switching! That includes switching from generic to generic, from brand to generic and from generic to brand. These medications have differences in the way they are absorbed into the body and different formulations effect patients differently. The important thing they are fighting for is that ALL changes in formulation of a medication be done only with the knowledge and approval of the patient and the treating doctor. Generics and brand name drugs do, when FDA approved, DO have differences in the ways they effect patients and we need to be informed, particularly when changing from one generic form to another. A break-through seizure in someone with good seizure control can be life altering and we deserve to know when the formulations of our medications are changed!

Anonymous said...

Dr. Poses states: "[t]he foundation theorized that some generic pills had a meaningful difference from the brands." Well, Dr. Poses, such is not theory; but fact. The use of various excipients in generic anticonvulsant medications is the most significant causal factor in variations of both solubility as well as permeability of such medications. This has been stated frequently in numerous medical journals as far back as 1970 (i.e. see PubMed case study search results pertaining to phenytoin intoxication). Unfortunately, many physicians (including some neurologists) are unfamiliar with such data, and they do a great disservice to patients suffering from epilepsy. The variations in the level of anti-seizure medication in patients subjected to irresponsible medical care (via prescription for generic from name-brand meds -- without careful forethought and appropriate oversight by the doctor who writes the prescription) often leads to tragic results (i.e. injury to the patient suffering a seizure, and even status epilepticus). I personally experienced extreme toxicity along with status epilepticus in 1985. Despite the wealth of knowledge available, my physician (a G.P.) at that time insisted he write a prescription for the generic form of the medication.
Once again, the difference between generic and name brand medications is not a theory, but a fact. Substitution of generic anti-convulsants for name brand anti-convulsants involves many variables related to the excipients; and therefore it requires import considerations, and extremely diligent oversight of the patient by the doctor.