As a physician who has worked in the fields of drug safety and clinical trials for many years, and who has diabetes myself, I was bemused by an e-mail I just received about a petition that's on the Internet. The e-mail states in part:
"A growing group of patient advocates, doctors, diabetes educators and other community leaders have banned [sic] together to "Ask the FDA to Better Serve Diabetes Patients' Needs." ... We're imploring the new FDA leadership to recognize the urgent need for more safe and effective treatment options for diabetes and to reduce barriers to innovation. Please see the online petition and letter at www.healthefda.com. We ask you to help speak out and get our voices as patients heard!"
Sounds great: a community of activated villagers banding together, carrying their pitchforks and torches, to fight the great fire-breathing dragon who threatens to destroy the entire village. Except it isn't true - the fire-breathing dragon doesn't exist, and it doesn't threaten the village.
The FDA recently released the text of a document "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." As the FDA explained in a press release December 17, 2008 (FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes):
"Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance."
"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."
In my opinion, this new guidance is NOT a "barrier to innovation" as the on-line petition suggests, and will not impair research into diabetes therapy. And it's not a surprise: The FDA put out a draft guidance about this in March 2008.
Yes, it's an added burden for pharmaceutical companies, but an entirely reasonable and relatively minimal one. People with diabetes rarely die of blood sugar levels being too high: they die of heart attacks. And heart attack rates are exactly the sort of information the FDA is requesting that manufacturers obtain during their clinical trials, before new drugs are put onto the US market.
It's entirely reasonable to gather information about what sort of cardiac risk (if any) that a medication might have before tens of thousands - or millions - of people with diabetes are exposed to it. And the added burden for the manufacturers is relatively minimal: new studies should incorporate cardiovascular endpoints and other safety measures, and for finished studies, a metanalysis of trial data should be done. Sure, this might take a bit of time and a bit of money, but it's not an undue burden.
The FDA's request makes sense to me. I won't sign the petition.