Tuesday, May 13, 2008

The ADA's Silence Is Deafening

It seems that almost every month, we hear yet another news story about problems at the U.S. Food and Drug Administration. Last December, even an internal report produced by the FDA itself entitled "FDA Science and Mission at Risk" (which can also be found at the Food and Drug Administration's website) concluded that the FDA was desperately short of money and poorly organized, which is putting people's lives at risk. This has Congressional lawmakers finally giving more serious consideration to their oversight (or rather, their lack of oversight) for the FDA, but money won't solve all the Agency's issues, more careful oversight is needed, too.

Back in early March 2008, I wrote that the U.S. Food and Drug Administration was soliciting public comments on the Agency's Draft Guidance for Diabetes Treatments (relevant to both drugs and biologic medicines). If ever there was an issue of importance to patients with diabetes, it is surely regulatory guidance on diabetes medicines. The deadline for public comments ended 2 weeks ago.

Naturally, I submitted a host of comments (8 pages to be precise) related to the draft guidance, although most of my comments pertained to type 1 diabetes since that impacts me personally. Although the FDA has not included individual comments in the docket (I suspect because they'll need to redact personal address information before making it available to comply with Federal policy), you might find the comments submitted by the pharmaceutical industry and their trade organizations such as PhRMA and BIO interesting reading (see the regulations.gov website here). I was heartened by the fact that the Juvenile Diabetes Research Foundation (JDRF) even submitted comments (although I think they missed many opportunities to advocate towards guidance that encourages cure therapeutics), but the organization did respond to the issue, and for that, they should be commended. Amazingly, however, the nation's largest, self-appointed diabetes advocacy organization, the American Diabetes Association was silent on this issue.

SILENT!

As my title suggests, the ADA's silence was deafening. How can an organization whose 501(C)3 status claims that its mission statement is "to prevent and cure diabetes and to improve the lives of all people affected by diabetes" have remained silent on this issue? These guidelines will outline how drug and biopharmaceutical companies develop, test and validate the safety and efficacy of new diabetes treatments for the next decade (if not longer) and the American Diabetes Association had no comments?!!? This is unacceptable!

EVERYONE in the diabetes community should be asking who's asleep at the wheel over there at the ADA's headquarters in Alexandria, Virginia?

If ever we needed validation that the American Diabetes Association is a wholly-owned subsidiary of big pharma and agriculture, surely this is it. You can, and should express your displeasure by writing to the ADA. But I would encourage you to avoid their general correspondence address, and instead direct your letters to the executives who run the organization (including John Buse, the current President) at the organization's headquarters' address:

John B. Buse, MD, PhD
American Diabetes Association
1701 N. Beauregard St
Alexandria, VA 22311
Tel: (703) 549-1500

The ADA also offers a toll-free support line at 1-800-DIABETES (1-800-342-2383) which is operational from Monday-Friday, 8:30 AM - 8:00 PM EST, but realize you are calling a call-center, not the organization's headquarters. By the way, the American Diabetes Association's IRS tax filings are available for the public to view at the Foundation Center's website, there you can see exactly what the ADA is spending its money on, where the money is coming from and how much key executives are being paid for their work.

6 comments:

Terry Keelan said...

Scott,

Your advocacy is inspiring. I'm sending this letter today:

"Dear Dr. Buse:
Is it true that the ADA made NO COMMENTS to the U.S. Food and Drug Administration on the Agency's Draft Guidance for Diabetes Treatments?
If so, the ADA has lost its entitlement to claim to be an advocate for people with diabetes and has failed in its mission statement "to prevent and cure diabetes and to improve the lives of all people affected by diabetes."
I am sadly disappointed in the ADA.
Sincerely,
Terry Keelan"

Terry

AmyT said...

Wow, Scott, thanks for airing this.

I just linked to this post in my Weekly Nuggets.

Best,
AmyT

www.diabetesmine.com

Anonymous said...

Scott--

I sent letters to headquarters, Dr. Buse, at North Carolina address, and Dr. Albright, in Georgia. Of course, that was only a week ago . . . so a response hasn't been received (nor is one expected).

Question for you: What does a 501(c)3 organization have to do to LOSE non-profit status. If they fail their mission statement, have quasi-corporate administrative costs, and use 26 cents out of every donated dollar to solicit more donations, are they really advocating, or just fulfilling a role a corporate emissary to the diabetic community? Who looks into the non-profit status? Perhaps a bit of sunshine would encourage the organization to either fess-up and get out of 'charitable work' or do some soul-searching and get back to basics. WOuld you suggest an inquiry to Congress or IRS or perhaps through postal inspectors (soliciting funds under false pretenses)?

Melody

Anonymous said...

The ADA has been in the past, and is right now the largest hindrence to the health of all Diabetics.
If a cure, and many have been documented,comes to their attention, it is immediately destroyed, so the ADA can continue as the supposed greatest supporter of Diabetics the world over. If they were to allow any cure to be released, they are outof business.
This desease has been a God sent to the ADA. Who stands to lose the most if you were to be cured?
Follow the money. V.T. John Martin

Elise said...

I would like to know why someone doesn't help with the cost of insulin?

I am a type 1 and without it I am likely to die. It cost #100 a vial without insurance and having Type 1 diabetes I have a preexisiting condition with makes it difficult to find insurance and then to afford the premium?

Why? Does the drug companies make the cost of insulin so high when someone's life depends on it?

It's been around since before the 1950's so it's most likely paid for it's self, right, please help me understand.

Why doesn't someone in Congress or the FDA or ?? come up with a plan to cut prices and make it affordable?

Again help me understand, thanks.

Scott said...

Elise, you raise an interesting point about the cost of insulin, but the Food and Drug Administration has nothing to do with that, that really should be addressed by the Federal Trade Commission which investigates monopolistic behavior which would certainly apply to the insulin oligopoly that dominates the U.S. insulin market. The reality, however, is that the cost of insulin is not as high as you are suggesting. Anyone can walk into a drugstore in the US/Canada and get Regular insulin for about $50 to $55/vial and not even require an Rx from a doctor to do it. Insulin analogues are roughly twice the price, and that is because they are still protected by patents (at least until mid-2012 when the patents for Humalog and Novolog will expire. Using costly analogues has less convincing evidence of providing better glycemic control, as a number of meta analyses of the clinical trials for these newer products have rightly called those conclusions into question because few of the studies have been blinded, which is a separate conversation. To cut your costs for insulin in half, switch back to regular and dose about an hour before eating. Not convenient, but certainly possible.