Friday, August 26, 2011

What Is Behind the Critical Shortage of Prescription Drugs?

Today, the critical shortage of prescription drugs reached the editorial page of the New York Times. Under the heading The Shortage of Vital Drugs, the paper said:
A widespread shortage of prescription drugs is hampering the treatment of patients who have cancer, severe infections and other serious illnesses.

The Food and Drug Administration says that some 180 medically important drugs have been in short supply, many of which are older, cheaper generic drugs administered by injection that have to be kept sterile from contamination.

A survey of 820 hospitals in June … found that almost all of them had experienced a shortage of at least one drug in the previous six months … As a result, more than 80 percent of the hospitals delayed needed treatments, almost 70 percent gave patients a less effective drug, and almost 80 percent rationed or restricted access to drugs.
The cause of this shortage? According to the editorial:
Nobody is sure just what is causing the shortages ... But several factors are likely to be involved: contamination problems at some manufacturing plants, forcing unexpected production shutdowns; difficulties in getting pharmaceutical ingredients from suppliers, especially those abroad; reluctance to invest in production-line improvement for low-profit generics when high-priced brand-name drugs bring in far higher profits. Sweeping consolidation in the generic drug industry means that fewer companies are left in that market to make up for a shortage.
The Times has become a trashy paper, more in the league of The New York Post than its previous self. Its stories are old, the opinions in its pages downright embarrassing. That is why I rarely quote it now.

Here, it blames “contamination” and the difficulties with the supply lines. The drug companies in question are some of the largest, most advanced industrial corporations in the world. They are the “Big Pharma”, some with over a century of experience in drug manufacturing; we are not talking about the chicken processing plants in Alabama and Georgia. The idea that they will allow contamination or suppliers to impact their output is laughable.

More than 3 months ago, the Financial Times had covered the same story in a greater depth. On May 4, in a news story titled Drug takeovers spark shortages it said:
Pricing pressures and takeovers in the US pharmaceuticals sectors have contributed to record medicine shortage and could put lives at risk, sparking calls for wide-ranging reform.

The American Society of Health-System Pharmacists said last year its members could not obtain an unprecedented 211 prescription drugs through the usual channels ...

Cynthia Reilly, director of the ASHP’s practice development division, said: “There has been a lot of consolidation among manufacturers, with fewer producing any given product, and more quality inspection by regulators. “For older, off-patent drugs, some companies are disengaging because it’s not where the profit is.”
Cynthia Reilly is barely touching upon the subject. The background of the drug shortage, in a nutshell, is that the century-old business model of pharmaceutical companies – doing research and bringing new drugs to market under the protection of the patent law – is no longer working. The problem is structural.

In the 1980s, the Big Three auto companies also faced a structural problem: they could no longer afford the social function of supporting their retirees. At one point, GM claimed $1,100 in the price of each car was earmarked for retirees' pension and insurance. With a nod from the company, the stories spread about GM being a retirement fund that also happened to make cars. In the face of stiff competition from then Japanese car makers, that could not be done. The rest is history, with bankruptcies, pension losses and layoffs.

The problem of the big pharma is likewise structural albeit of a different nature. “Structural” is the key word, though. It means that there is no cure. The business model is dying and, naturally, the vultures have descended on the scene.

Here is one, as per The New York Times of January 26, 2005, under the heading Making a Fortune by Wagering That Drug Prices Tend to Rise. As you can see, the problem has been in the making for some time.

Over the last 20 years, the packing and shipping of drugs evolved into a game of arbitrage, called speculative buying, with distributors like Mr. Rahr (who paid $45 million cash for an East Hampton estate) wagering on drug price increases.

This common industry practice seems more fitting to a casino than a distribution warehouse. And in the 1990’s and the early years of this decade, with prices far outstripping inflation, it was a sure bet…..

Mr. Rahr would not disclose exactly how much he made through speculative buying. Goldman Sachs estimated that the distribution industry, which is dominated by three large public companies, made 60 percent of its profit, or $980 million, from speculative buying in 2001, when the practice was at its peak. More recently, Goldman Sachs estimated speculative buying’s contribution at 40 percent of profits.
In some ways, the practice helped drug manufacturers, who relied on speculative buying in lieu of paying distributors to get drugs to pharmacies. In effect, it was a form of hidden compensation that never showed up as a cost to manufacturers. But speculative buying fostered many problems, industry analysts and economists said. Some said it played a role in drug cost inflation by adding an incentive for manufacturers to raise prices repeatedly. It also gave sometimes gave drug makers false signals that products were in demand, prompting them to turn out excess product.

By encouraging distributor stockpiling, the system also led to shortages in some regions of the country, a situation known as a “stock out” and one that the industry does not like to discuss. Last year, Bristol Myers Squibb paid $150 million to settle allegations … that it misled investors by aggressively encouraging wholesalers to flood their warehouses, thus artificially inflating its sales.
That’s all. Unless you want to know about Mr. Rahr, the sophisticated Brooklynite with his “trademark yellow ray ban glasses”. Then google him. Interesting character, he.

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