Trials and Errors

IT'S REALLY AMAZING that marijuana sells so well without the benefit of advertising or promotion. Contrast that not only with all those "Ask your doctor" commercials for prescription drugs, but also with the number of lobbyists for the pharmaceutical industry: 526. There are only 535 members of Congress for them to lobby. Furthermore, a recent survey of 100 researchers who write the clinical practice guidelines for medical journals found that nine out of 10 admitted to having financial ties to the drug industry.

According to Dr. Marcia Angell, former editor of the New England Journal of Medicine, "Most consulting arrangements are simply a way for researchers to make money and for the industry to buy their good will. Researchers serve on advisory boards and speakers' boards, and they travel around the world, ostensibly to educational programs. But really, they are just enriching themselves, and the drug companies retain influence over them to a remarkable extent."

For example, the Associated Press reported in May 2003 that Warner-Lambert's kickback schemes to physicians who prescribed Neurontin for "off-label" uses for the drug (it was originally intended only for the treatment of epilepsy) included a 1996 meeting in Atlanta where doctors were given tickets to the Olympics and use of a spa.

A lawsuit by whistleblower David Franklin unearthed documents showing that Warner-Lambert circumvented the Food and Drug Administration's drug-approval process by avoiding the large clinical trials required for the government's blessing of off-label uses for Neurontin. Instead, the company carried out an elaborate public relations campaign, providing financial incentives to hundreds of doctors to prescribe Neurontin for non-approved uses. They paid ad agencies to conduct small clinical studies, then had the results published in medical journals, and even hired ghostwriters to help write those articles.

The New York Times reported in May 2003 that "Warner-Lambert paid dozens of doctors tens of thousands of dollars each to speak to other physicians about how Neurontin could be prescribed" for unapproved off-label uses. "The top speaker for Neurontin, Dr. B.J. Wilder, a former professor of neurology at the University of Florida, received more than $300,000 for speeches given from 1994 to 1997. Six other doctors, including some from top medical schools, received more than $100,000."

On a smaller pay scale, Warner-Lambert also "spread the word about those studies by inviting doctors to lectures, dinners and weekend retreats." They hired doctors, for fees of $500-$2000, to speak to their colleagues, presenting positive messages about the drug. On one occasion, marketers offered a doctor $200 just to memorize references to "Neurontin that they wanted him to drop casually into the dinner conversation."

But there are certain facts that he did not bring up between asking a fellow physician to please pass the bleu cheese salad dressing and the salt, praising the chef for the subtle yet masculine tastes of the sirloin steak and garlic mashed potatoes, and requesting a waitress to bring him another serving of that delicious chocolate ice cream sundae with walnuts and extra whipped cream if you don't mind.

Neurontin was initially approved by the FDA only as a treatment for epilepsy, which provides a relatively small potential market, but the concocted uses have turned it into a "blockbuster," which is defined by the Wall Street Journal as any drug that sells at least $1 billion per year. In 2000, Parke-Davis (a subsidiary of Warner-Lambert, which in turn was acquired by Pfizer) earned $1.3 billion, and $1.7 billion in 2001. Moreover, 78 percent of those sales were for uses without evidence that it was safe and effective.

In May 2004, Pfizer agreed to pay $430 million—the second-largest criminal fine ever imposed in a healthcare fraud prosecution—for illegally marketing Neurontin for uses it had no scientific evidence to support, even in cases when the drug was shown to be ineffective. Whistleblower Franklin will receive $26.6 million as part of the settlement.

The government's complaint stated that the promotion amounted to an "illegal and fraudulent" scheme that put patients at risk. In June 2004, Pfizer formally pleaded guilty. It has been estimated that 90 percent of Neurontin's $2.7 billion in sales last year were for off-label use. There are more than a dozen illegally promoted uses—none of which has ever been approved by the FDA—for which Neurontin has been prescribed. According to the consumer advocacy group, Public Citizen, a few samples:

Bipolar Disorder "Psychiatrists were told that early results from trials indicated a 90 percent response rate to the drug, but no such results existed, and in fact Parke-Davis was in possession of clinical data indicating" its ineffectiveness.

Pain Syndromes, Peripheral Neuropathy, and Diabetic Neuropathy Scientists and doctors who prepare articles for medical journals are "kept" by drug companies—known in the trade 35 years ago as "the stable" and now euphemized as "medical liaisons"—"were trained and instructed by Parke-Davis to report that 'leaks' from clinical trials demonstrated that Neurontin" was highly effective and that a 90 percent response rate in pain management was reported. No evidence of the sort existed.

Restless Leg Syndrome Medical liaisons were trained to refer to a growing body of evidence relating to the disease, although no such scientific data existed. The only reports were anecdotal, the majority of which had been sponsored or created by Parke-Davis.

The prevalence of greed and the absence of ethics in the legal/corporate drug industry were revealed by a senior marketing executive at Parke-Davis, who "was quoted during a teleconference as saying to medical liaisons":

"Pain management, now that's money. Monotherapy, that's money. We don't want to share these patients with everybody, we want them on Neurontin only. We want their whole drug budget, not a quarter, not half, the whole thing... That's where we need to be holding their hand and whispering in their ear, 'Neurontin for pain, Neurontin for monotherapy, Neurontin for everything'... I don't want to hear that safety crap, either. Have you tried Neurontin? Every one of you should take one just to see there is nothing, [that the drug is safe] it's a great drug."

He didn't mention any side effects when, ironically, side effects are necessary to prove the drug is working. From one of Neurontin's own websites: "Troublesome side effects are probably the main reason for patients and doctors deciding to greatly decrease or wean off Neurontin. However, encountering brainfog, the staggering effect, and the sleepiness are now considered positive for showing that the doses are appropriate. [In other words, if one doesn't encounter these side effects when first starting out, the dosage is too low.]"

One other thing: "Many users have found that hydration is vitally important while using this drug. A small amount of water retention is normal, especially when ramping up (increasing) doses. If you find that your rings are tight and/or your toes are swollen, and you are drinking less than four quarts—that's 16 eight-ounce glasses—of water a day, you may find that increasing your intake of water will help eliminate any excess fluid..."

Are they kidding? Jeez, I don't even drink the incessantly recommended eight glasses of water a day. And nobody I know does, either. Maybe all those bottled-water companies hire medical liaisons too. o