Back in May, I featured a post titled "The ADA's Silence Is Deafening" asking how the self-appointed doctor's organization which claims to represent the needs of all people with diabetes could possibly have remained silent on an issue which will surely impact people with diabetes for decades to come -- namely the FDA's proposed guidance on diabetes drugs and biopharmaceuticals.
One of my readers shared this sentiment, and wrote directly to John Buse, and received a reply from the American Diabetes Association. Rather than cite excerpts from the letter, its easier if you read it yourselves (see here for details).
The reason provided was that they concluded that "the proposed regulations were appropriate and a formal response from the organization was not necessary". They also noted that a committee had decided that comments on the Food and Drug Administration's Drug and Biopharmaceuticals Guidance should "come from individuals" rather than from an organization of doctors who are supposed to represent our needs -- like the FDA routinely considers the opinions from individuals the same way they do from doctors ... officially, that may be what the law dictates, but in practice, that seldom happens.
Anyway, it is worth mentioning that yesterday and today, the FDA has assembled a panel of "experts" to consider whether drug makers should be forced to study the cardiovascular effects of type 2 diabetes drugs. The move is prompted largely by the groundbreaking journal article authored by Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. Dr. Nissen discovered the GlaxoSmithKline web site while researching the type 2 diabetes drug Avandia and discovered data indicating a strong cardiovascular disease correlation to the drug. The New England Journal of Medicine released his findings that Avandia was associated with a 43% higher risk of heart attack.
Since then, there is an effort to ensure that other treatments do not trade one problem for another. The meeting notes for the FDA workshop can be seen here. A draft of questions to be discussed can be viewed here. At issue is whether the use of HbA1c as a "surrogate" for improved patient outcomes, the single element diabetes medicines have always been evaluated for, is appropriate. The FDA is now weighing whether to insist that new diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar. A shift away from current research benchmarks, known as surrogate endpoints, might change the entire framework of drug approval because research on most medicines relies on such "surrogate" measures.
The American Diabetes Association has remained largely on the sidelines of this issue, too. But a statement from the ADA published in The Wall Street Journal suggests what's really going on:
The American Diabetes Association, a patient advocacy group, hasn't taken a position on the use of surrogate benchmarks.
ADA Vice President Sue Kirkman said in a statement: "We don't want it to become nearly impossible to bring effective new drugs to market, which requiring long-term pre-marketing [cardiovascular] studies might do."
In other words, the ADA is more concerned about impediments for new drugs, not whether those drugs are necessarily safer or more effective for patients. Does anyone else need any more convincing about who the ADA is there to serve (hint: the pharmaceutical, biotech and medical device companies)?
Update as of July 2, 2008:
On Wednesday, July 2, 2008, an advisory panel said that U.S. regulators (meaning the FDA) should require more testing of the potential heart risks of new diabetes medicines.
By a 14-2 vote, the advisers to the Food and Drug Administration recommended companies conduct a long-term study or provide equivalent evidence to rule out an unacceptable risk of heart problems for proposed new diabetes medicines.
Some data could be collected before approval with additional results provided after the drug reaches the market, several panel members said.
If the FDA adopts the advice, drugmakers could be forced to run longer and more expensive studies in a larger group of patients. The agency usually follows the advice of its advisory panels.
Scott--
ReplyDeleteSue Kirkman's comments leave me fuming. As you so accurately point out, the emphasis is placed on enabling pharmaceuticals to quickly bring drugs to market. Just because NEW drugs hit the marketplace does not mean diabetics will benefit. NEW is NOT synonymous with better, or even effective.
A look back at the rDNA approval will show that the 'surrogate' end point for rDNA human insulin was MERELY its ability to lower blood sugar. To my knowledge, the post-marketing study demanded by the FDA has never been completed--and the ADA (which I can assure you KNOWS of many complaints regarding rDNA insulin) has remained silent. Is this ADVOCACY, or what?!
Do any of your readers have a passing acquaintance with the IRS? It would be interesting to audit the ADA financials, weigh the money taken in versus the money spent in pursuit of their mission--advocating for ALL diabetics. If the ADA sees itself as a mouthpiece for diabusiness/insulin cartel . . . then let them become a for-profit consultant. If donors REALLY knew what the ADA does, I suspect it would be a less affluent association.
Melody
If everyone would as of today stop contributing $$ to the ADA
ReplyDeletebecause they do not represent the needs of those w/T1DM or even T2DM, it would not matter.
They would still exist as an organization onto themselves because the Pharmaceutical Industry and Bio-Tech would provide them with the necessary money to remain.