Tuesday, May 21, 2013

The Game is Rigged: Episode 1

I read with great interest an April 25, 2013 Time Magazine article describing an incredible discovery that might, just might spell the end of insulin injections for the treatment of diabetes. From the halls of Harvard's Stem Cell Institute Doug Melton and postdoctoral fellow Peng Yi have discovered the hormone betatrophin, which quite simply has the potential to improve by leaps and bounds ongoing treatment for type 2 diabetics.

There's a catch of course. More on that later...

Diabetes is a horrible disease. It is insidious and devastating in it's potential to reek havoc on the sufferer. It is a stealth disease that often lurks undetected and with no outward signs or ill feelings. It can, if left untreated, lead to stroke, heart disease, blindness, kidney failure, coma and vascular disease which often ends in foot or leg amputation  - a horrible affliction indeed. It has been known about for 3500 years and until 1923 it was literally a death sentence. This discovery could be the biggest break for diabetics since the invention of animal insulin.

This hormone, called betatrophin, was observed to cause laboratory mice to produce insulin-secreting pancreatic beta cells at up to 30 times the normal rate. The beauty of it is these new beta cells only produce insulin when called for by the body, mimicking the pancreas' natural regulation of insulin with the potential for great reductions in the complications associated with diabetes. Such exciting news, right?

The catch is that politics and big business are so involved with the multi, muti-billion dollar diabetes maintenance industry that no one is just going to stand by while this, this discovery spoils that party.

To understand just how despicable and evil this is consider first the brief description offered earlier of the nature of this disease and then multiply that by millions. Today 25.8 million people in the United States have been diagnosed diabetic and nearly 350 million world wide suffer from this disease - and the numbers are increasing exponentially. These are epidemic proportions yet because it kills slowly it is the perfect disease to profit from. The blood testing supply business alone is a multi-billion dollar industry. Imagine if this new treatment reduces the need for testing to a fraction of what it is today.

In fact the history of manufactured insulin is fascinating and instructive. In 1921 Canadian scientist Fredrick Banting and grad student Charles Best labored many months on experiments that brought them closer to a solution to the treatment of diabetes than ever before. In December of that year Banting, Best and John Macleod had produced an extract from whole beef pancreas mixed with alcohol that successfully lowered the blood glucose levels in a dog whose pancreas had been removed.

It was James Collip who helped the team to purify its insulin extract. This purified version would prove successful in the first clinical trials conducted on human patients with diabetes at Toronto General Hospital. After publishing their results they set about mass producing their "insulin" but the encountered so many problems they were forced turn to the Eli Lilly Company. Banting and Best traveled to Indianapolis to work with company chemists to produce the revolutionary extract insulin.

 On Jan. 23, 1923, Banting, Collip and Best were awarded U.S. patents on insulin and the method used to make it. Later that same year, Banting and Macleod were awarded the Nobel Prize in medicine for the discovery of insulin. Now here's the key part of the story that contrasts with the extreme greed of today... Banting, Collip and Best all sold these patents to the University of Toronto for $1 each. Absorb that for a minute.

Animal derived insulin was cheap and readily available for decades. It saved countless lives and allowed diabetics not only to live but live well. Fast forward to 1970's when the first fully synthetic insulin was created by Ciba-Gieigy. It was in 1982 that Eli Lilly licensed Genentech's process for creating recombinant human insulin after it was proven effective in controlling diabetes. By then the "health insurance model" was well entrenched and the cost of the new synthetic insulin was exorbitant compared to the porcine variety.

This story is well told by my good friend who went on a failed quest to find the cheap animal derived insulin.

As the patents run out on synthetic insulin we expect as we do with all other drugs that generic manufacturers will soon be flooding the market and prices will fall. Fat chance. You see the game is rigged...

Synthetic insulin is known as a “biologic” drug and unlike for instance aspirin which is an assortment of chemicals that anyone can manufacture biologics are regulated differently. Therefore generic makers aren't allowed to "piggyback" on the original pharmacological trials. Since this would cost too much the generics pass on it. There is no reason that generics couldn't produce safe, cheap synthetic insulin it's just the FDA won't let them. Nice win for big pharma.

So here we are possibly on the cusp of the next big thing in diabetes treatment. So excuse me when I sigh after reading that big pharma is all over the betatrophin story. Potentially diabetics may be able to reduce their need for insulin altogether and get by with one betatrophin injection a week or even one a month. Considering the potential for crumbling such a huge profit industry I envision these injections costing $400 -$1000 a pop or maybe more. Surely the government will intercede, right? Call me cynical, but I see the government stepping in not to help end the suffering of millions of people rather to stop the suffering of shareholders.

But I could be wrong...