Tuesday, August 02, 2005

Pharmaceutical Follies, Part III

About six months ago, the Los Angeles Times ran a story stating, “at least six of the nation’s largest companies already have issued internal notices to their work forces, preparing them for potential ambushes.” Warnings at these companies had nothing to do with terror attacks or homeland security matters. The initial cautionary pronouncement came from a Pfizer Global Research and Development spokesman, citing the latent danger as “a scruffy guy in a baseball cap.” He went on to say that if you see such an individual, “you’ll know who it is.” While this may seem to be a meager description that might fit any number of people, shortly thereafter, Sanofi-Synthelabo and Aventis (the two since merged) also identified this same character as a threat, and three other pharmaceutical companies, Glaxo Smith Kline, Astra Zeneca, and Wyeth, instructed employees that questions posed by the media or filmmakers should be handled only by corporate communications personnel.

By now you might have guessed that the scruffy one is the notorious Oscar winning filmmaker, Michael Moore. After hitting on targets such as General Motors (“Roger & Me”), the gun lobby (“Bowling for Columbine”), and his most recent and controversial focus, President Bush (“Fahrenheit 9/11”), Moore’s next target includes insurance companies, HMO’s, the Food & Drug Administration—and drug companies. The new project’s tentative title seems most appropriate—“Sicko.” Also “sick” over Moore’s latest subject matter are Merck, Abbot Labs, Eli Lilly, Bristol Myers Squibb, Novartis, and even the largest generic company, Teva Pharmaceuticals. All send periodical messages cautioning employees to refer comments to communications officials.

Why is the industry so concerned with Moore’s project? M.J. Fringland, senior director of communications for the Pharmaceutical Research and Manufacturers of America (PhRMA), Pharma’s trade association located (where else?) in Washington D.C., summed it up as follows: “We have an image problem. We’re criticized on the Hill and in the press—put in the category of the tobacco industry, even though we save lives.” What they really have is a crisis, one that might be exacerbated when Moore’s film is released early in 2006.

A good portion of the “image problem,” as well as the mountain of criticism recently directed at the pharmaceutical companies, can be attributed, at least in part, to a series of revelations outlined in three books released last year that seem to belie the notion that corporate and industry activities are primarily focused, as Mr. Fringland claims, on “saving lives,” as opposed to producing excessive profits.

By contrast, the primary goal of the medical profession is to save lives. In fact the modern version of the Hippocratic Oath, using wording suggested by the American Medical Association’s Code of Medical Ethics states in part, “That whatsoever house you shall enter, it shall be for the good of the sick to the utmost of your power, your holding yourselves far aloof from wrong, from corruption, from the temptings of others to vice.” While it is probable that most physicians adhere to these high standards, there are some (as in any profession) who succumb to inducements offered, in this case, by drug companies, presumably in their efforts to maximize profits.

Any activity of this nature on the part of a physician would, of course, be a direct contravention of the terms of that oath. Nevertheless, these recently published books direct severe criticisms to the entire drug delivery industry, associated governmental agencies, academic and media institutions, as well as the medical profession. One in particular On the Take: How Medicines Complicity with Big Business Can Endanger Your Health, directs a barrage of criticism at the questionable, even unconscionable activities of some physicians, all of whom purportedly took an oath containing words similar to the one above.

Although it is true that “you can’t judge a book by looking at the cover,” a correlative adage might read, “You can usually judge a book by examining the background, credentials and reputation of the author.” In the case of the above mentioned book, the author is Dr. Jerome Kassirer, whose prominence, experience and distinction are beyond question. Originally a full professor of Medicine as well as Vice Chairman of the Department of Medicine at Tufts University, in 1991 he was appointed Editor-in-Chief of The New England Journal of Medicine, and served in that position for eight years. He is currently distinguished Professor of Medicine at Tufts.

Since it would be impossible to do justice to the full import of the book’s 272 pages, I will take the admittedly easy (but also most effective) way out by plagiarizing, if you will, part of the publisher’s (Oxford Press) recap of the book’s content:

“We all know that doctors accept gifts from drug companies, ranging from pens and coffee mugs to free vacations at luxurious resorts. But as the former Editor-in-Chief of the New England Journal of Medicine reveals in this shocking expose, these innocuous-seeming gifts are just the tip of an iceberg that is distorting the practice of medicine and jeopardizing the health of millions of Americans today.

In On the Take, Dr. Jerome Kassirer offers an unsettling look at the pervasive payoffs that physicians take from big drug companies and other medical suppliers, arguing that the billion-dollar onslaught of industry money has deflected many physicians’ moral compasses and directly impacted the everyday care we receive from the doctors and institutions we trust most. Underscored by countless chilling untold stories, the book illuminates the financial connections between the wealthy companies that make drugs and the doctors who prescribe them. Kassirer details the shocking extent of these financial enticements and explains how they encourage bias, promote dangerously misleading medical information, raise the cost of medical care, and breed distrust. Among the questionable practices he describes are: the disturbing number of senior academic physicians who have financial arrangements with drug companies; the unregulated “front” organizations that advocate certain drugs; the creation of biased medical education materials by the drug companies themselves; and the use of financially conflicted physicians to write clinical practice guidelines or to testify before the FDA in support of a particular drug.”
Is that description representative of the Hippocratic Oath or the Hypocritical Oath?

In his book, Kassirer describes many benefits provided to physicians by the pharmaceutical industry that permeate much of academic medicine and private practice. It is estimated that a quarter of academic scientists have financial ties to industry. “Companies offer them seats on scientific advisory committees (for a fee), lucrative consulting contracts, and stock options that could be worth millions of dollars. Even doctors in private practice can enjoy rewards by accepting bounties for enrolling patients in studies, or signing up as ‘consultants’ in exchange for being flown to exotic locales to hear lectures about a company’s products.” [While some of these activities can serve legitimate purposes, there still exists a basic inherent conflict of interest.] An investigation by The Boston Globe revealed that based on industry liaisons, one head of an academic medical department garnered more that $400,000 in a single year.

A front page article just a month ago in The Wall Street Journal related that despite the army of close to 100,000 drug company representatives (or “detailers” as they are known) knocking on doctors’ office doors daily, the most highly effective method by far, used to promote the sales of a given medical product is through the use of doctor-led discussion groups. While this system of lecture programming might be considered a benign form of an educational process, quite often a more insidious profit purpose underlies the effort. Although, this is covered by Kassirer, another book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, describes the objective as follows:

“Suppose you are a big pharmaceutical company. You make a drug that is approved for a very limited use…How could you turn it into a blockbuster?...You could simply market the drug for unapproved (“off-label”) uses—despite the fact that doing so is illegal. You do that by carrying out “research” that falls way below the standard required for FDA approval, then “educating” doctors about any favorable results. That way, you could circumvent the law. You could say you were not marketing for unapproved uses; you were merely disseminating the results of research to doctors—who can legally prescribe a drug for any use. But it would be bogus education about bogus research. It would really be marketing.”

The credentials of the author, Marcia Angell, are similar to that of Jerome Kassirer in that she too was Editor-in-Chief of The New England Journal of Medicine, succeeding Kassirer in that role, and is now a Senior Lecturer at the Harvard School of Medicine.

Would drug companies really stoop that low to expand their profit potential? Last year, Pfizer paid $430 million to settle False Claims Act Law lawsuits involving the marketing of its anti-seizure medication Neurontin, for unapproved uses after a sales executive blew the whistle on the practice. Five drug companies including Pfizer have already paid $1.457 billion in fines and penalties to settle cases of fraud. It has been reported that federal prosecutors are investigating an additional 150 cases involving 500 drugs alleging pricing fraud by some of the world’s largest drug makers that could produce more than $1 billion in criminal fines and civil penalties. These cases involve not only marketing drugs for unapproved uses but allegations reported in The Wall Street Journal that “drug companies cheat state and federal healthcare programs by inflating prices, and offering undisclosed rebates to distributors.”

Dr. Angell is sharply critical of the pharmaceutical industry posing as the wellspring for innovative and creative medications. She maintains that the main output of the big drug companies is “me too” drugs—minor variations of highly profitable pharmaceuticals already on the market. She points to the proliferation of the cholesterol controlling statins, with currently six not too dissimilar versions doing the same job, their successes depending not necessarily on performance but on marketing skills. Verifying her claim is the fact that from 1998 through 2003, 487 drugs were approved by the FDA. Of these, 379 (78%) were classified by the agency as “appearing to have therapeutic qualities similar to those of one or more already marketed drugs.” And 333 (68%) weren’t even new compounds. Only 67 (14%) of the 487 were actually new compounds considered likely to be improvements over old drugs.

In a similar vein, throughout the 90’s, the top 10 drug companies consistently spent 35 percent of sales on marketing and administration and only 11 to 14 percent on research and development. During that decade, profits were 19 to 25 percent of sales. Angell claims only a handful of truly important drugs have been brought to market in recent years and they were mostly based on taxpayer funded research at academic institutions, small biotechnology companies and the National Institute of Health.

Merril Goozner, former chief economics correspondent at the Chicago Tribune, comes to similar conclusions in his book, The $800 Million Pill: The Truth Behind the Cost for New Drugs. He disputes the pharmaceutical industry claims that high drug costs are justified by the necessity to spur the creation of new and better drugs, as well as the figure of $800 million often cited as the average price tag of what it costs to develop them. That figure was derived from a report done in 1991 by Tufts University. However, a more recent study funded by the Rockefeller Foundation and the Bill and Melinda Gates Foundation in 2001, estimates the cost to range from $115 million to $245 million.

We may have to wait for the scruffy little guy in a baseball cap to enlighten us in 2006, but with the new Bush generated prescription drug plan about to go into effect, one thing is certain: Like Ol’ Man River, those drug profits will “jus’ keep rollin’ along.”

1. Despite the nature of the above article, it should be disclosed that the author’s son is a physician. 2. This, and recent past articles, including Parts I and II of this series, can be accessed on the Internet at bobkronish.blogspot.com. 3. For truly cheaper drug prices, you might consider ordering from Israel. The website easiest to navigate for this purpose is www.magendavidmeds.com. Prices can be readily checked and they appear to be some 25%-40% cheaper than Costco, the cheapest local drug retailer by far.