The ADA's "Investigation" of Incretin Drugs is a Gift to the Drug Companies

UPDATE 6/20/2013: Here's an excellent summary of ALL the studies pointing to serious problems with all the incretin drugs. There are a lot of them from many different kinds of research and they make it crystal clear that the American Diabetes Association's claim discussed below that the research about incretin drugs causing pancreatitis and cancers is ambiguous is an industry-sponsored lie.

 Pharmlot: Troubling New Signals? Diabetes Drugs & Adverse Event Reports

ORIGINAL POST

You may have heard that the American Diabetes Association (ADA) had called for a review of the incretin drugs--Januvia, Onglyza, Byetta, Victoza, etc.--in response to the recent discovery, which I described HERE, that they cause abnormal patterns of growth within the pancreas of a kind that lead to both pancreatitis and cancer.

The call for review can be read HERE.

Sadly, this call for review has nothing to do with protecting people with diabetes, a group for whom the ADA has never had much concern, save as a source of contributions to pay the inflated salaries of its top executives.

The ADA is heavily funded by drug manufacturers, and this call for review is an attempt to protect the profits of the companies who make the incretin drugs. That this is the case is made crystal clear in the ADA's call.

They state, "A recent case control trial examining autopsy specimens suggested that exposure to sitagliptin or exenatide in a small number of subjects increased neoplastic changes in the pancreas of subjects with type 2 diabetes to a greater extent than that seen in nondiabetes subjects or diabetic patients treated with drugs other than incretins. This analysis has been criticized from a methodologic standpoint and remains unconfirmed. [emphasis mine]"

This last statement is an out and out lie. The only criticism I have been able to find of Dr. Butler's brilliant study came from a PR flack working for one of the drug companies. Dr. Butler's research validated previous findings in animal research, and it was all the more compelling because though it used "a small number of subjects" taking incretin drugs, every single one of them had abnormal cells, cell growth patterns, and neuroendocrine tumors in thier pancreases after years of taking these drugs--and NONE of the normal people or people with diabetes not taking incretin drugs had these changes or tumors in their pancreases.

The "review" the ADA is calling for, is largely an analysis of previously published research which it believes will show no problems with these drugs. As the ADA's call  points out "Administrative database analyses suggest either no effect on pancreatitis or a small risk associated with incretin therapy, but it is less than that due to obesity or alcohol ingestion."

The ADA's specific prescription in the "call" is that, "Independent review of available clinical and pathologic data be conducted. Toward this end, the Association is calling on all pharmaceutical companies with incretin therapies in development or currently marketed to make patient-level data available on all subjects involved in regulatory trials for an independent analysis."

This review is guaranteed to find no problems because, a) the drug company's studies do not include any study of the actual pancreases of the subjects. Remember none of the people autopsied by Dr. Butler's showed ANY symptoms of anything amiss in their pancreases before death. b) The drug company data only covers a brief time period, far too short a period for tumors visible with image technology to develop, or for pancreatitis to occur as a result of abnormal patterns of beta cell growth. c) Drug companies have a long and ugly history of hiding data that might dissuade doctors from prescribing their most profitable drugs, and the incretins are the single most profitable drug category of most of the large drug companies.

So this "review" is guaranteed to find nothing so that the ADA's sponsors can keep selling these highly profitable drugs to every newly diagnosed person with diabetes. But any sense of security the review establishes is delusory, because  the highly abnormal cell growth that Dr. Butler found in the pancreases of all the people taking these drugs, who died with no idea that their pancreases had become abnormal,  betray the kinds of changes that though they do, eventually kill people, kill people slowly.

Pancreatic tumors are completely undetectable until they reach the point where they are almost universally fatal. They do not show up on scans until they are much larger than the tumors Dr. Butler discovered. So it may take ten years for the abnormal cell growth and small tumors found in the pancreases of people taking incretin drugs to grow to the point where they start killing the people now taking these drugs--the oldest of which, Januvia, has only been on the market for 6.5 years.

Professionals who care about the health of their patients should be calling NOT for "reviews" of existing demographic research, or relying on the drug companies to provide evidence about the drugs' safety. They should be asking why, if these drugs massively enlarge the beta cell mass of people who take them, the blood sugar of people taking incretin drugs continues to be much higher than normal, and, in fact, worsens the longer they take the drugs. (A finding documented by research discussed HERE.)

They should be looking at  the glucagon levels in people taking these drugs to see if they are abnormal, which would validate Dr. Butler's finding that the abnormal beta cells grown in response to incretin therapy secrete glucagon not just insulin.

And finally, they should demand that the ADA apologize to Dr. Butler for making completely unsupported attacks on what was a brilliantly conducted, highly technical piece of research.

It won't happen. Instead, this window dressing "review," will find, based on the fact that until now incretins haven't killed enough people to rise to significance, that these drugs are "perfectly safe."

The ADA's press releases will saturate the medical and popular press. Doctors, reassured by the findings of the review will continue to prescribe these drugs to every new patient with diabetes.  In another five or six years, when the patents on these highly profitable drugs have expired, the first wave of pancreatic cancer deaths and the pancreatitis epidemic will begin, and they will continue for years to come.

But few will know that these deaths were caused by the incretin drugs. The ADA will assure the public that this wave of deaths is just a terrible, tragic hitherto not understood complication of diabetes, since it has found all the diabetes drugs to be completely safe.

The drug companies will have booked their profits, so they won't care. The ADA's executives who commissioned the study at the request of the drug companies will be enjoying retirements funded by the huge salaries the ADA pays them, or have moved back to their original jobs as highly paid drug company lobbyists.

But you don't have to be one of the victims. If your doctor suggests you take any one of these very worrisome drugs, point your doctor to Dr. Butler's findings (which you will find HERE) and demand that he think critically about any claims of safety made by the ADA's venal flacks.

If you can't normalize your blood sugar by cutting back on carbs and exercising, stick with the safe drugs: Metformin and insulin (and Prandin for those of you who respond very strongly to beta cell stimulation.)

The drugs to watch out for are: Januvia, Janumet, Onglyza, Combiglyze, Victoza, Trajenta, Jentadueto, Byetta, Bydureon, and Victoza.  There are more in the pipeline. Any drug whose mechanism involves DPP-4 inhibition or which is a GLP-1 analog falls into the incretin family.