Patent Baristas

Conflicts of interest in the pharmaceuticals area have been in the news quite a bit lately. I don’t think that it indicates any new trend or that the world going to hell in a handbasket. I think if you want to know the root of the issue, you need look no further than the bottom line for drug sales. The global pharmaceutical market is forecast to grow to $842 billion in 2010. Just the top 16 new blockbuster drugs in 2005 generated combined sales of $18.1 billion. These eye popping numbers can put a lot pressure on the marketplace – some innocent, some not so innocent.

The Regulations

Federal doctors now say drug maker Eli Lilly & Co. subtly influenced the development of medical guidelines for treatment of sepsis (an often fatal blood infection). Guidelines are meant to reflect independent medical opinion but too much corporate influence could lead to corporations trying to guide health care in ways that benefit them directly.

Doctors at the National Institutes of Health claim in the New England Journal of Medicine that Lilly worked through medical societies to influence standards for treating sepsis where its drug, Xigris, was incorporated into the guidelines. The sepsis guidelines urge that very ill patients at risk of dying get the novel anti-clotting drug Xigris, the only medicine approved for the disease. A $6,800 treatment can help protect organs destroyed by the bacterial infection, once called blood poisoning. About 750,000 cases occur in the United States each year, and nearly one-third prove fatal. The U.S. Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee.

Lilly acknowledged hiring a marketing firm and paying doctors and ethicists to launch a campaign about choosing which patients to treat in the intensive care unit. But the company said its efforts were educational and had the goal of making sure only the appropriate patients were treated with Xigris. Experts disagree as to whether Lilly’s role was improper in this case since the money was given in an arms-length transaction and the doctors were free to reach their own conclusions.

The Regulators

But, money always has a way of finding its own conclusions. Ex-FDA Commissioner Lester Crawford pleaded guilty on Tuesday to two charges resulting from his ownership of stock in companies the agency regulated. Crawford, who resigned from the FDA last year, admitted to making false statements on financial disclosure forms and violating conflict-of-interest laws. Each count carries a maximum fine of $100,000 and up to one year in prison.

According to DOJ prosecutors, government ethics officials told Crawford in 2002 that he and his wife needed to sell shares in 12 companies that were regulated by FDA. The couple sold shares in nine of the companies — which included Johnson & Johnson, Merck, Boston Scientific, Pfizer, Medtronic and others — but kept shares in three companies: food and beverage maker PepsiCo; food distributor Sysco; and Kimberly-Clark, which makes some consumer health care products, DOJ said. In addition, Crawford’s wife held shares in Wal-Mart, which also is regulated by FDA, but Crawford did not include those holdings in his 2002 financial disclosure, DOJ said. Crawford also failed to disclose that he held options to buy 41,500 shares in Embrex, an FDA-regulated poultry biotechnology company on whose board he once served.

From August 2003 through June 2004, Crawford and his wife owned 1,400 shares of PepsiCo stock worth at least $62,000 and 2,500 shares of Sysco worth at least $78,000, according to court documents. It doesn’t help that that the Crawfords continued to hold the PepsiCo, Sysco and Kimberly-Clark shares despite being told by ethics officials at the Department of Health and Human Services (HHS) that they had to be sold. In 2004, an HHS ethics official inquired about Crawford’s ownership of Sysco and Kimberly-Clark stock. Crawford’s wife also retained shares in Wal-Mart Stores Inc., also regulated by the FDA, prosecutors said

The Regulated

According to a study of doctors published in the Journal of Medical Ethics, one in three doctors believe that their decisions on which drugs to prescribe have been affected by receiving drug samples from pharmaceutical sales representatives. Nearly all of the doctors, 94 percent, distributed samples to patients based on financial need. Sixty-three percent of the time they said effectiveness in treating patients was the reason. In 2003, the pharmaceutical industry spent $25.3 billion on drug promotion, including distributing $16 billion in free drug samples to doctors, the study said.

Noteworthy was that 92 percent of doctors felt that it was more acceptable to take drug samples than any other “incentive item,” such as a free lunch or a position as a paid consultant. Almost 60 percent of doctors distributed samples to “build a good relationship with the patient,” and almost 90 percent said they distributed the samples because they were available.

In recent months, several academic medical centers, including Yale University and the University of Pennsylvania, have barred drug-company sales reps from bringing free lunches to staff physicians. And on Sept. 12, Stanford University announced that its physicians will no longer be able to accept gifts of any size from any type of vendor, including biotech companies and medical-device makers.