Time for the FDA to be held Accountable

Time for the FDA to be held Accountable

“There is no clear mechanism by which drugs cause pancreatitis.” 

This statement comes from an article entitled Drug-induced pancreatitis which appeared in the November/December 2006 issue of the Canadian Pharmacists Journal, authored by Ayman Eltookhy, BSc(Pharm)and Norma Lynn Pearson, BSc(Pharm)


“Many drugs have been reported to be associated with acute pancreatitis. However, lack of rechallenge evidence, consistent statistical data, or evidence from experimental studies on a possible mechanism prohibit definitive conclusions about most of them.” This statement comes from an article published in Drug Safety, June 1996.

“Among adverse drug reactions, pancreatitis is often-ignored because of the difficulty in implicating a drug as its cause. The physician should have a high index of suspicion for DIP, especially in specific subpopulations such as geriatric patients who may be on multiple medications, HIV+ patients, cancer patients, and patients receiving immunomodulating agents.”  This was the conclusion of a paper appearing in the Journal of clinical gastroenterology September 2005


“The diagnosis of drug-induced acute pancreatitis often is difficult to establish. Although some medications have been shown to cause acute pancreatitis with a large body of evidence, including rechallenge, some medications have been attributed as a cause of acute pancreatitis merely by a single published case report in which the investigators found no other cause.” Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, June 2007


We could go on here, as there is even more articles that show that there is little evidence that proves drugs can cause pancreatitis, but it would be pointless. What isn’t pointless is the question that must be on everyone’s mind, Why did the FDA act on Byetta when all available evidence suggests it’s difficult if not impossible to prove a direct causal relationship between Byetta and pancreatitis?


As we mentioned yesterday the fallout from this disaster goes beyond investors and hits were it really hurts, the patient. While Diabetic Investor does not offer medical advice here is sample of the type of emails that have showed up in our inbox, “I have a friend using byetta who is concerned about its safety since hearing about cases of pancreatitis.  What can you tell us about the relative safety of Byetta”


According to the FDA their mission is “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”


Take a look at that last sentence “helping the public get accurate, science-based information they need to use medicines” – someone needs to explain to Diabetic Investor what accurate, science-based information lead them to issue this warning on Byetta. Has the FDA ever heard of something called a statistically relevant sample size or incidence rate? Do they understand the concept that patients with diabetes are at an increased risk of pancreatitis? Has anyone at the agency bothered to read any of the articles that have appeared in respected publications? Have they thought about picking up the phone or sending an email to any of the experts to get their input?


It’s clear had they done so the agency may not have been so reckless with their action. It took Diabetic Investor about an hour to search the internet to find the articles we cited above. A simple Google® search reveals a vast amount of information.


Once again instead of doing just a tiny amount of research the FDA acted rashly. They were neither accurate nor science-based as their mission states. They were careless, lazy and irresponsible. Worse they will not suffer from their rash action. Unfortunately the patients who use Byetta, the physicians that treat them and investors are the ones who must suffer needlessly.


This being an election year we can only hope whoever is elected as our next President will bring accountability to our government agencies. As William Bennett said, “Responsible persons are mature people who have taken charge of themselves and their conduct, who own their actions and own up to them- who answer for them.” It’s about time the FDA began answering for their actions. 

David Kliff
Diabetic Investor
fax 224-715-3761 mobile