Jay Kuten: Spit out TPP's poison pill

Danger: Actions by the US Food and Drug Administration have resulted in monopolies on generic drugs and huge price hikes. Photo/AP

ON A WEEKEND visit with a colleague/friend in New Hampshire in the US, it suddenly became apparent he had developed a case of gout. The symptoms of gout are classic. The initial attack is often on the large toe of the victim and the experience is one of intense itch becoming sharp throbbing pain.

Historically, gout has been associated with high living. You've probably seen an etching of some stout fellow, reclining in his armchair with remains of a sumptuous meal complete with beer mugs, his bandaged foot astride a stool. Formerly, only the affluent were diagnosed with gout, the "disease of kings." Members of the working class with the very same condition were given the less exalted diagnosis of "rheumatism."

Gout can affect any joint. It's a disease of purine metabolism in which excess serum uric acid crystallises in joints as painful spicules. Gout was recognised by the Egyptians in 2640 BCE. A treatment for lowering uric acid, colchicine, derived from the autumn crocus, was first used in the 6th century.

It is still in use today. And that is where our story really begins. My friend, Dr Jones, is a teetotaller, an active outdoorsman and a vegetarian. He asked me to prescribe some colchicine.

Colchicine was a generic medication in the US for decades. And therefore inexpensive. The internet listed colchicine among at least 100 other generics that Walmart sells for US$4 ( $5.75) for 30 pills or $9 ($12.93) for 90 pills.

A call to Walmart proved disappointing. The internet figures were accurate until 2011. Then the generic manufacturer was bought out and the new company - a monopoly - changed the pricing structure. Thirty pills now cost US$186 ($267).

Colchicine was not the only generic, long-established medication that increased in price dramatically. It turns out that these price rises were the result of actions by the US Food and Drug Administration. Either this was the unintended consequence of good intentions or perhaps more ominously, regulatory capture.

The FDA and the pharmaceutical companies they are supposed to regulate have a convoluted history. The generics story originates in the FDA's decision to require that old drugs be tested to prove their safety. URL, a pharmaceutical company did studies on Colchicine and got FDA approval and an effective monopoly. However, the studies were done on just 187 patients who either got placebo or colchicine. It's hard to see how that study justifies a 5000 per cent price increase. Of course, colchicine is not the only "old" medicine to get the new treatment; 86 other generics have had a similar fate, study-wise and price-wise.

In New Zealand the price of colchicine would be $5 per prescription. Our Pharmac functions to maintain low prices for necessary medications by utilising generics, usually post-patent copies of brand-name drugs.

But New Zealand doesn't manufacture these generics and must buy them from overseas.
It was considerations like this that led me to question the wisdom of New Zealand's signing the TPP. The Investor State Dispute Settlement provisions are poison pills that Winston Peters recognised and wants to renegotiate - as Australia has already done. It's the intellectual property clause and its extended patent protections that imperil our generic medications scheme. The last government's Trade Minister, Todd McClay, easily gave unsubstantiated assurances that net costs would be less than $500 million. Yeah, right.

Now that a new government is in place, we need to hold them to the task of protecting our Pharmac scheme.

Nobelist Joseph Stiglitz writes that the intellectual property regime dictated by advanced countries does not actually encourage innovation - the chief rationalisation for it. Instead it merely protects corporate profits.

Jay Kuten

■Jay Kuten is an American-trained forensic psychiatrist who emigrated to New Zealand for the fly fishing. He spent 40 years comforting the afflicted and intends to spend the rest afflicting the comfortable.