October 18, 2007

Two Million Human Guinea Pigs

Merck announced recently that patients have filled two million prescriptions for its new diabetes drug Januvia.

Wall Street Journal "Diabetes Drug Wins New Uses

It also announced that new and potentially worrisome side effects have turned up, all relating to the immune system, including rashes and swelling and one potentially fatal condition, Stevens-Johnson syndrome, where the skin literally peels off the body.

Januvia was approved after only 2 years of testing in only a few thousand patients. In addition, as I have pointed out in previous blog entries, the antiquated drug approval system does not require that drug companies look at potential problems caused by novel ways in which a drug functions.

So a drug, like Januvia, that turns off the part of the immune system now known to kill cells that have become cancerous before they become tumors, is NOT tested to see if those kinds of cancers are promoted by the drug. The required drug approval cancer tests only look to see if the drug itself causes cancer in cells in test tubes or in certain animal models which may not develop kinds of cancers humans do.

I cannot say it enough: Januvia changes the way the Immune System works in ways that are not understood by science. It does that by inhibiting the action of an important enzyme/protease, DPP-4, which is used through out the body and brain.

There is no question that Januvia does what Merck claims it does, which is suppress DPP-4, the enzyme responsible for destroying GLP-1, so that GLP-1 levels rise and, in people with living beta cells, stimulate the beta cell to secrete insulin.

But what is not known is what else happens when you suppress an enzyme used in the brain, used to kill rogue cancer cells, particularly melanoma and prostate cancer cells, and for a host of other functions.

Many of these effects may take more than the two years Merck tested Januvia to become evident in the group of patients taking the drug. Because drug companies have every incentive to avoid looking closely at the health of study participants five years after they participate in a drug trial, these long term effects may go unnoticed--or ascribed to chance or other causes, as happened with Avandia.

In addition, because the initial studies were small, severe and even fatal side effects like the promotion of melanoma, might not turn up in these very small study populations. A severe side effect that impacts .01% of a study population and takes 3 years to become evident will not show up on a 2 year study. But with two million people taking the drug, that may translate into 200 people who die needlessly.

A "rare" side effect that shows up in 5% of people taking the drug in 5 years could kill 100,000 people.

Do you really want to take this kind of risk for a small decrease in blood sugar that you could achieve just by cutting out some of the carbohydrates in your diet?

Some people may think I am an extremist, but it's worth noting that I posted on my Main Diabetes Site. about the rashes developing with Januvia almost six months ago. I was the first person to write online about the potential impact of DPP-4 inhibition on the promotion of melanoma.

And just last month, 6 months after I stopped taking Januvia I had another highly suspicious skin growth removed which my doctor told me was well on its way to turning cancerous. He found it unusual for such a growth to appear so suddenly (I get regular skin checks because I am a melanoma survivor.) I did too, which is why I rushed to the skin doctor when I noticed it. It started as a small zit during the period I was taking Januvia.

I only hope that Januvia did not promote the growth of rogue melanoma cells within my body during the three months I foolishly tried it, because if it did, I'll find out only when they are close to killing me. That is how melanoma works, and why you are crazy to be taking a drug, like Januvia, that impacts the system the body uses to kill cancerous melanocytes.