December 8, 2008



Original post:







One study of prostate cancer cells studied in a culture medium concluded

Here's the abstract of that study:


The other study involved melanoma cells and had this to say,

Here's the abstract of that article:




Enhanced secretion of glucagon-like peptide 1 by biguanide compounds.


You can read the research that found this connection here:







More Evidence Connects Januvia to Cancer,

UPDATE Later the same day:




Scott said...

I am hopeful (but not naive to think it is guaranteed) that the FDA's use of "surrogate endpoints" as the sole criteria for approving diabetes drugs has finally come to an end. This began last year with the FDA's review of its criteria, and Steve Nissen at the Cleveland clinic was a big factor in pushing for expanded criteria.

We are already seeing this with the delay given the Amylin/Lilly's Byetta LAR, but also with a number of other drugs that big pharma had planned on being given a rubber-stamp approval have since been delayed for more information. The reality is that reduced HbA1c does not guarantee improved patient outcomes, but with that as the primary requirement, a number of questionable drugs were approved.

Let's hope more conservatism in reviewing drugs will be the mantra in coming years.

Jenny said...


While the issue you raise is a step in the right direction, the reason LAR wasn't approved is because of a problem already identified with Byetta--the possibility of pancreatitis. As I understand it, the problem with a longer acting drug is that it makes it impossible to cease taking the drug if pancreatitis appears.

But the problem with Januvia is different--it is that testing HAS NOT BEEN DONE to check out a major problem indicated by basic research.

I just heard from one of the researchers whose papers I cited that inhibiting DPP-4 with a diabetes drug does sound like a very bad idea, but that NO research has been done to see if these drugs inhibit the anit-tumor activity of DPP-4.

No drug company will fund that research, and researchers are too dependent on drug companies for grants to undertake it on their own.

So we really need another level of questions to be asked during the approval process.

The Old Man and His Dog said...

Nice blog! You are one of the reasons I am now on Byetta and off of Januvia. Thank you for caring.

uwak said...

this medicine still need test and test....cause still new, some report say that the power to control blood glucose more low than su

Ween said...

I am pretty certain that lowering my glucose to normal decreases my chance of developing blindness, kidney failure and amputation. Diabetes is the leading cause of these scourges. So what is wrong with the FDA using lowering of glucose or lowering of HbA1c as a "surrogate" marker of benefit. To Dr. Nissen at the cleveland clinic I say: I am blind and on dialysis (and my leg has been cut off), but thank goodness I did not have a heart attack because he saved me from taking Avandia. To Jenny: I am now blind and on dialysis and my leg has been cut off, but thank goodness my prostate cancer did not spread because I did not take Januvia.

My point (in case you missed it) is, who gets to decide what risks we should take when we take a pill or are prevented from taking a pill? Should the FDA decide that Januvia worsens the risk of prostate cancer and thus ban it? or should I decide if I want to take the drug and lower my risk of retinopathy, nephropathy and neuropathy?

Jenny said...


If Januvia allows a cancer to go metastatic you won't live long enough to go blind or get amputations.

It takes at least 10 years for severe diabetes complications to develop.

Melanoma or ovarian cancer that has gone beyond stage 2 usually kills within a year. Since melanoma develops in the linings of the digestive system, not just the skin, it can be undetectable until it is at stage 4.

The survival statistics for prostate cancer are misleading because there are two kinds--a slow growing form most people survive and a fast growing form that kills within two years. Do you really want to risk turning a slow growing cancer you could live with to one that will kill you in two years?

If there were no other ways of lowering blood sugar, one could argue that there is a place for these dangerous drugs. But the point is that THERE ARE OTHER SAFER TREATMENTS that are equally effective. Neither Januvia or Avandia/Actos do much for blood sugar control. They cause about a .5% drop in A1c overall. Neither is powerful enough to lower the kinds of blood sugars that lead to blindness and amputation to a safer level.

Only cutting down on carbohydrates and adding insulin can drop a 10% A1c (which is the kind of level at which complications accelerate) to even the anemic 7% A1c at which point they still occur but less frequently.

Anonymous said...


This is off subject, but how can I open a thread about the DOT's senseless discrimination against commercial drivers who need to take injectible insulin?

I am more than willing to discuss this discrimination at leangth with you, but please don't post my email address. It is This address is for your use only in contacting me.

Thank you.

stant7 said...

I don't get it. Reviewing Merck literature they quote 2 year rat cancer studies and it seems reasonable. I'd welcome your comments. Here is the link to the reference:

Jenny said...

Rat studies have failed to find cancer relationships with many drugs and chemicals that are linked to cancer in humans.

The human findings in the clinical trials DID point to excess cancers--that is what Dr. Goldstein's letter in Annals of Internal Medicine pointed out. It isn't a huge number, but then the number of cases of melanoma aren't huge overall.

Another drug,. Anakinra, which also impacts DPP-4 levels produced a couple more cases of melanoma than "expected" in clinical trials, but was still approved. The problem is that 2 or 3 extra cases per thousand when applied to many hundreds of thousands turn into a lot of people who might not have died.

And with Januvia, they did NOT track the incidence of the individual kinds of cancers known to respond to DPP-4. That's another problem with the rat study. The rise in cancer is relatively small and it takes thousands of subjects to see it.

But for those of us who are cancer survivors or men over 50 most of whom harbor cancerous cells in the prostate this is an issue. And because doctors aren't aware that there is a link between DPP-4 inhibition and cancer, they don't report prostate or melanoma deaths in Januvia patients, so there is no way of learning that the number of such deaths has risen.

LocalGP said...

Thanks Jenny for the excellent and critically important inputs. I am practicing in a region (non US, non European)where this Drug (Januvia) has established itself as safe (no hypoglycemia)option in diabetes. My worry is that GPs are widely prescribing it as almost first/second option in Diabetes, and tragically even public health institutions are dispensing it freely. This is happening in an area of the world where the official poverty line (income per day) is lower than the cost of one tablet of Januvia; and a large section of the population is below poverty line. in addition to the legitimate and profound concern about cancers and diversion of cost to an ineffective drug; I personally feel that it may actually be associated with more frequent episodes of hypoglycemias (needs discreet, independent reaprraisal).

Jenny said...


I'm pretty sure that the mechanism by which Januvia lowers blood sugar should not cause hypos because the insulin secretion should stop when blood sugar is under the threshold where 2nd phase kicks in. It may cause "false hypo" in people who are used to high blood sugars.

The main side effects people have reported to me are severe rashes, joint inflammation that does not resolve when the drug is discontinued, headache, nasal congestion and severe constipation. These are all in line with what the drug does. If you read up on DPP-4 on the gene database you'll see that it does also act in the sinuses.

But I hear you on the criminality of prescribing a drug that expensive when there is a safer, very cheap alternative available. And don't get me started on why there isn't generic insulin available at a cost people can afford.