Wednesday, December 19, 2018

The Gila Monster versus The Gilead Monster

Halting or seriously slowing the until now inexorable progression of Parkinson's disease may hopefully be in the offing.  Two  trials -- phase one, open label (2013) and phase two, double blind (2017) -- found no worsening of motor ability after one year for treated groups.

The potentially Parkinson's stabilizing drug, Exenatide (Byetta, Bydureon), along with similar GLP-1 drugs, has been widely used for managing Type II diabetes.  For diabetics, Exenatide increases insulin and cuts glucose proportionately to how much they eat (the smart drug) and slows digestion -- mimicking a hormone already existing in their bloodstreams (therefore tending to few side effects) but lasting hours or days instead of minutes.  And as the TV commercials say: they might even lose a little weight.

My personal experience with Byetta and Bydureon was losing 50 pounds in 50 weeks without effort -- needed to lose 100 -- keeping my A1C (blood sugar) level at 5.7 (very good) and, after five years, going into remission.  The latter is relatively unusual.

Exenatide was developed in the Bronx VA, by endocrinologist Dr. John Eng. The story of how he extracted the possibly twice-useful molecule from the saliva of a Gila monster (pronounced "Hila") is here:

Beautiful blow-up of a fat Gila monster pictured here:

Two miracles for the price of one.
  * * * * * *

From Gila Monster to Gilead monster: whence through the roof pricing of another miracle drug has a less happy ending.  Harvoni (Sovaldi + laedipasvir), a 95-99% cure for Hepatitis C, is kept out of patient circulation for all but the most sick by piratical pricing: starting out at $94,000 for a 12 week treatment -- that costs a few hundred dollars to manufacture -- dropping off maybe half as copy cat competition looms.

Sovaldi was developed by VA
organic medicinal chemist , Dr. Raymond Schinazi, working in labs of his own company that he founded, Pharmasset.  Dr. Schinazi had previously developed two front line HIV drugs, lamivudine and emtricitabine, in VA labs, one or the other of which is found in 90% of the combination anti-viral regimens taken by US HIV patients.

Dr. Schinazi worked on salary while leading the research on the two (unpronounceable) HVC prescriptions but profited $446 million (!) on Sovaldi, when his own firm was bought for $11 billion by Gilead.  He proclaims: "There is nothing better than saving lives."  He would exercise his genius for public or private coin.  He says he has nothing to do with Gilead's pricing.

Some least developed countries (LDCs) exercise TRIPS treaty rights to suspend patents in the face of widespread epidemics, such as AIDS or just plain critical public health needs and the impossibility of paying high patent premiums.  This practice is called "compulsory licensing."

Though not many countries have exercised this option with not many drugs -- South Africa, Brazil, Thailand (in 2007 for HIV, cancer, cardio), Ecuador, Indonesia -- so far, the US has not condoned a single instance.

US drug monopolies add up to tariffs for other countries -- and at 1,000 percent or 10,000 percent rates, not 25 percent.  In India Gilead prices Harvoni at just $999 a treatment --  perhaps afraid of what India might do if it tried to price it sky high. 
 * * * * * *

If India and or China (not a compulsory licensing issuer) or any group of countries would like to break American drug monopolies they can simply offer the American public the medicine to wipe out Hep C in a single stroke for a miserly $1 billion (earning themselves a nice hundreds of millions manufacturing profit, assuming similar production costs) -- but US drug patent laws would have to double-reverse their incentives to make it legal to accept the $299 billion saving, and miss out on the years of needlessly spreading disease.

One (of many?) possible revamps: replace US drug patent structure with government funded research on drugs and medical devices -- all new drugs becoming generic.  For already patented drugs, erect a regulated monopoly system similar to electric power distribution models.  Harvoni, for example, having long since paid off Gilead's (not very chancy) $11 billion dollar gamble could be immediately designated generic.

Secretive patent competition slows proliferation of new scientific knowledge -- leads to copy-cat research displacing real pioneering -- or to no effort at all to repurpose existing treatments as patent incentives run down and out.

The Phase Two Parkinson's trial was paid for by the Michael J. Fox Foundation -- AztraZeneca not being particularly interested as its patent was running down.  An effort is now being mounted to support a phase three trial which could lead to connecting this life liberating research with all Parkinson's sufferers.

"Taxpayers — not Big Pharma — have funded the research behind every new drug since 2010"  --   Alexander Zaitchik

Today the US government funds over $25 billion a year worth of drug research.  Private pharmaceutical firms puts up $50 billion.  Big pharma spends more on advertising than research -- justifying even higher prices to supply "incentive?" 

How could American politicians explain not taking an offer to one-shot, wipe out Hepatitis C, for a pittance (that it should cost here)?  Would Americans willing face paying Gilead and copy cats $10+ billion a year waiting out patent runs -- as more sufferers come down with Hepatitis and 20,000 a year die -- when there's something they can do about it?

Dr. Schinazi, whose family hails from Egypt says, "Today they have cured HVC from over 600,000 people using generic and proprietary drugs in Egypt; they are relatively cheap but in those days it was life and death. Everybody wanted that drug, the people lined up for miles trying to get it. Every family in Egypt was affected."

This could be a first-world story too.