Cohen, Nader, Rosenfeld, Kelly Address Drug Company Leaders

I found myself in some heady company in Boston last March at a meeting of 450 drug company marketers. Speaking to this group was a challenge, considering the title of my recent book, Over Dose: The Case Against The Drug Companies (for reviews, click icon).

But I was invited by Bob Ehrlich, a former drug company executive who directed the launching of Lipitor in 1997, one of the most successful drug launches in history. Ehrlich now directs a consulting agency and sponsored the Direct-To-Consumer Conference, yet we share the common vision that greater attention to patients’ concerns about medication side effects would benefit all participants in healthcare.

The first keynote speaker was Patrick Kelly, the near legendary president of Pfizer U.S., which led the drug industry with $18.721 billion in sales, an increase of 11.8%, in 2002.1  Pfizer also spends the most on promotion, $1.394 billion in 2002, and it does so very effectively. Kelly was preaching to the choir, but his presentation was powerful nevertheless and produced a standing ovation.

“This was my toughest audience, 450 drug industry officials who weren’t thrilled by my billing as the author of
Over Dose: The Case Against The Drug Companies.“

After Kelly’s “all’s right in our pharmaceutical world” speech, Ralph Nader followed with the fire and brimstone. Nader condemned many facets of drug industry marketing and the failure of FDA review. Citing repeated examples of drug advertising that he considers inappropriate, Nader said, “The lack of FDA action and ad agency creativity is a prescription for recidivism that makes a mockery of law enforcement.”

Noting that Congress isn’t likely to give the FDA the power to levy fines, Nader told the drug markers, “You don’t need a regulation to change that. You just need some advertising morality.”2   Nader disdained the use of celebrities to promote products, arguing that drug advertising should be more educational.

Many attendees expected more of the same from me. But as a keynote speaker, my goal wasn’t to point fingers, but to convey the message that neither patients, doctors, the FDA, nor the drug industry benefit when medication side effects are the #4 leading cause of death in the U.S. and drive millions of patients from badly needed treatment.3  Having watched several sessions in which marketers wrestled with the problem of 50%-75% of patients quitting treatment for high blood pressure, high cholesterol, and other major conditions, I explained that merely encouraging patients to stay on their drugs doesn’t work. Most people quit treatment because they get tired of side effects like sedation, dizziness, muscle pain, constipation, depression, sexual dysfunctions, and many others.

“Ralph Nader provided the fire and brimstone. But I wanted to convey a different message: medication side effects are a major problem for everyone in healthcare — and most side effects can be prevented.”

Side effects that the medical profession and drug industry consider minor aren’t minor to patients. I explained why so many side effects occur, how we fail to adjust doses for individual patients, and that when you use the same doses of powerful drugs for Shaquille O’Neal, Ally McBeal, and Grandma Moses, you’re going to over-dose a lot of people. Other industries make products in all kinds of sizes and types to match buyers’ desires, but the drug industry uses a one-size-fits-all model that may be expedient, but isn’t efficient in preventing medication reactions. If you’ve read Over Dose, you know that I go into this in great depth, with cases and studies proving that half and quarter doses of statins, antidepressants, antihypertensive, anti-inflammatories, antihistamines, GI drugs, etc., work for millions of people without provoking side effects.

Dr. Isadore Rosenfeld, the health editor of Parade Magazine and a frequent TV commentator, spoke after me. He offered a broad survey of the healthcare system and, despite his lively humor, the picture wasn’t pretty: angry patients, striking doctors, 41 million people without healthcare coverage, Medicare in crisis, widespread dissatisfaction with managed care, and the high cost of drugs. Despite new technology and longer lifespans, Rosenfeld rued the disappearance of the old-time doctor-patient relationship. “Doctors have been transformed from healers to fixers. I appreciate all of the technology that helps me with my patients, but I wish that humanity, the art of medicine, was still a part of medical care.” Right on.

Dr. Rosenfeld also criticized the medicalization of normal human behavior. “There is a wide spectrum of human behavior and not everyone necessarily needs drugs for all of it.”2   Dr. Rosenfeld was referring to so-called conditions like “female sexual dysfunction,” an issue I raised earlier in the conference, whereby new “disorders” are suddenly identified and drugs are then pushed as the solution.

The funniest moment of the conference occurred in a debate between drug advertising supporters and detractors. Among the latter group was Mr. Nader and malpractice attorney, Stephen Sheller, who told the industry that it ought to start working on a “greed pill” for itself. That stopped the show for awhile.

I wanted to speak with Dr. Rosenfeld and, particularly, Mr. Kelly, but they left too quickly. I did get a chance to chat with Ralph Nader (who’d read Over Dose and praised it). I like people, and I liked Ralph. No matter which side of the political spectrum you support, there’s little disagreement that he’s brought some important safety changes to our way of doing things.

“Dr. Rosenfeld rued the loss of the old-time closeness between patients and doctors. Attorney Sheller challenged the drug industry to develop a `greed pill’ for themselves.”

Was my own message to the drug industry heard? After my presentation, at least 25 people told me it was the most informative, useful talk of the entire conference. On the other hand, 425 people didn’t, so it’s difficult to interpret. The post-conference survey showed that my talk ranked high for its content and message. Subsequently, Pharmaceutical Executive Magazine, the leading magazine to drug company executives, asked me to write an article for them. They felt that my message was important. The article appeared in May.

Overall, this experience matched being invited as the keynote speaker last November at the FDA Clinical Pharmacology Division’s Annual Science Day. I didn’t know what to expect there either, but many people were very supportive of my low-dose approach. Now, insiders tell me that my work is having some impact on the drug industry and FDA. In meetings, officers are asking whether the lowest, safest doses of new drugs have been defined. But even if this has an impact, it will take many years to help consumers. I haven’t seen much improvement in the newest drugs that have been released. So I’ll keep writing and speaking until we start applying basic medical principles to everyday medication treatment.
1. NDCHealth, a healthcare information services company. Atlanta, GA, Apr. 1, 2003:www.ndchealth.com.
2. Dickinson, J. Good to brief doctors on new drug developments. Dickinson’s FDA Webview, 3/27/O3:www.fdaweb.com
3. Lazarou, J, Pomeranz, BH, Corey, PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998 Apr 15, 279(15):1200-5.
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