Diabetes Drugs and Clinical Trial Results

By Dr. Bill Quick, Health Pro Wednesday, September 10, 2008
Clinical trials of new drugs, or drugs on the market, are expensive, and have to have a clear purpose. For a drug that's in development, and hasn't yet been approved for sale, the purpose is usually to generate data on efficacy and safety, and eventually get approval. For a drug that's about to get a...
Endos as PCPs
Anonymous
Jenny
9/10/08 4:56pm

Dr. Bill,

 

Your CV posted elsewhere on the web said that you yourself are employed by a competing drug company. Shouldn't you be disclosing this when you blog about drug company activities?

Dr. Bill Quick, Health Pro
9/10/08 10:30pm

Hi, Jenny.

 

Yes, I was previously employed by pharmaceutical companies, including several that make diabetes products. But, as indicated in my profile at this website, my employment for over a year has been at i3 Research, a major CRO, where I am involved with designing and managing diabetes and other endocrine trials.


Bill

 

Anonymous
Jenny
9/11/08 11:09am

Dr. Bill,

 

CROs are companies that contract to do drug acceptance testing for the major drug companies, right?  And one reason you would be hired by them is because of the value of your decade of experience and the contacts you made while working for those drug companies.

 

So when bashing a drug company you really should disclose your own drug company connections. It isn't ethical not to. Having disclosed them, of course, you have every right to share your personal opinions about what is going on.

 

And if you really want to be digusted at something, why not be disgusted at the way that Merch has hidden the cancer incidence statistics about Januvia, a drug that is now being treated as a "first line" drug though previous research shows a .5% increase in cancers in people taking it. With the lab research linking DPP-4 inhibition to the growth of cancers, the cancer data about Januvia is extremely significant. But the company is only reporting side effects with a 2% incidence and putting cancers in the same bucket as benign growths though 95% of the growths in earlier studies were cancers not benign.

 

With 6 million prescriptions for Januvia being written we are looking at 54,000 additional cancers at that .5% rate.

 

Which is why bashing the much safer and much more effective drug, Byetta, is doing the public a disservice.

 

DPP-4 inhibition promotes melanoma, ovarian cancer, colon cancer, and prostate cancer according to non-drug company sponsored research cited by Dr. Mark Goldstein in Annals of Internal Medicine.  The Januvia research discussed at EASD did NOT cite the cancer statistics for the latest studies but that is because they were under 1%. 


For the 54,000 people who may get melanoma or colon cancer from Januvia, that is a tragic omission.

9/10/08 5:19pm

I've often thought of these industry produced "studies" as commercials for docs.  That is, the drug companies saturate TV and magazines to push their pills onto consumers, but for docs they need a more sophisticated form of commercial.  So they package these studies in colorful folders and market them to the docs over some surf-n-turf.  Indeed, healthcare is so awash with drug company cash, that the ironic first response here shows it's systemic- even the whistle blowers get a cut!  Last time I was in a docs office, I went to lay down on that exam-bed-thingy, and noticed that the disposable cover was an advertisement for pepcid!? (this was not a GI office).  I found it truly offensive to be captive audience to a drug company ad in the intimacy of a doc office visit.  My advice to all doc office decorators- get rid of all the drug ads lying around in the examination cubicles- they're unethical.

9/16/08 5:30pm

Dr. Bill, I refer you to an article in the Clinical Journal of the American Society of Nephrology that challenges the claim of effectiveness of all oral hypoglycemic drugs to make a statistically meaningful difference in morbidity and mortality for diabetics. Producing good surrogate numbers, such as loweing blood sugar, is not the real goal of treatment, and yet that is the measure used for evaluating diabetes drugs.

 

Oral Glycemics and Diabetic Nephropathy  by Dr. Nortin M. Hadler 

Clin J Am Soc Nephrol 3: 159-162, 2008

 

 www.cjasn.org 

 

 

9/16/08 8:39pm

Dr. Bill, I have always found you to be helpful and supportive for all of us with diabetes. I was surprised when you seem less than supportive to a medication that has changed the lives of so many persons with diabetes for the better. I have been on Byetta for over 3years and has changed my life from hardly living to thriving and looking forward to more and more health. I am not alone. I am sad for all those who read and believe you and so do not give Byetta an opportunity to assist them to have a full and healthy life. Right, it doesn't work for everyone but for those for whom it does it makes all the difference. The MD who cares for me has over 500 patients and not one has contracted Pancretitis.

Dr. Bill Quick, Health Pro
9/17/08 6:33am

My concern isn't the drug, but the marketing of the drug. Sadly, this way of doing business is widespread, as others also have commented.

 

As a physician, I'm interested in science, not marketing hype. And in my opinion, this trial was a total waste of money that could have been spent on worthwhile scientific research -- or perhaps even in cutting the price of the drug?

Anonymous
EDDIE
9/17/08 12:23pm

I HAVE BEEN A DIABETIC 20 YEARS AND I MORE CONFUSED NOW THEN EVER BEFORE AS TO WHICH PRODUCT WORKS BEST, I DONT KNOW WHAT TO DO ANYMORE, I GET UP IN THE MORNING AND MY BLOOD SUGAR IS 145 ON AVERAGE, I HAVE ONE CUP OF COFFEE JUST MILK NO SUGAR, TAKE MY PILLS AND SOMETIMES INSULIN, AND 30 MIN OR AN HOUR LATER I AM AT 295 I JUST DO KNOW ANYMORE ITS BEEN A LONG HARD BATTLE THAT I SEEM TO BE LOSING.

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By Dr. Bill Quick, Health Pro— Last Modified: 10/11/11, First Published: 09/10/08