I will support these assertions and make a series of recommendations for how to improve our relationship with Pharma. At its best, this industry is focused on creating new treatments we and our patients need. Pharma is not just about profits and driving up health care costs. Physicians and Pharma do compete for a constrained health care dollar, and Pharma has substantially increased its share of it. As physicians, our credibility with the public may be at stake as more and more media attention is being paid to a perception that we have been "bought."

Free samples are the most commonly given reason physicians say they see drug reps, and yet samples are only the newer, more expensive — but not necessarily better — medications. For the treatment of hypertension, the JNC 7 lists diuretics and beta blockers as the preferred first treatments, drugs that are very inexpensive and not available as samples. Thus sampling tends to be inflationary as patients start, and then stay on, newer, costlier therapies. Even the programs for the poor benefit Pharma in two ways:

1. Pharma sees a significant amount of public goodwill (and tax write-off) for their charitable efforts; and

2. Uninsured and other low-income patients get started on "their drug," while most uninsured patients are uninsured only temporarily.

One of Pharma’s most effective strategies goes back many years. In 1966 Dr. Robert Wilson published a popular book — Feminine Forever — that introduced the public to the idea of "ovarian failure": creating a disease out of what had been considered a natural life transition for women. The publication was paid for by Ayerst, the makers of Premarin. "Prediabetes" as a concept was heavily promoted in educational sessions paid for by the makers of Troglitazone, a drug aimed at insulin resistance, which might be used to stall or prevent the onset of diabetes. And Dr. Jennifer Berman graced the cover of the October 2, 2005, Los Angeles Times Magazine for a cover story about her clinic to treat "female sexual dysfunction," a clinic funded by Pfizer, makers of the treatment for FSD: Viagra.

I became interested in this subject after attending an excellent Pri-Med conference in September 2000. After the first five lectures, I realized I could identify a single drug that was the obvious best treatment for each of the diseases being discussed. Over the course of the weekend, 16 out of 17 lecturers subtly informed us about "the" answer to their subject. No surprise that that "answer" was a product of the lecturer’s sponsor in every case. Four hundred primary care physicians learned from excellent, well-intentioned "thought leaders" to prefer the marketed treatment.

The companies choose these thought leaders in part by sending "surveys" to us asking who we would go to in our community to seek help in a given specialty and by offering us $100 for the information. Coach is a company whose brochures offer us $500 to attend a promotional seminar and then give one. And while the companies seek willing and well-compensated speakers to teach us, they also identify "negative thought leaders" and ask their reps to gently discredit them (San Diego Union-Tribune, 7/20/05).

University faculty members are often paid consultants to Pharma and sometimes generate huge incomes for themselves and the universities. Florida State University receives $1 to 2 billion per year as a royalty for its part in helping Bristol Myers Squibb develop Taxol. Columbia University receives $3 billion per year for helping create the process to reproduce Epogen/Procrit. The American Academy of Dermatology has promoted Pharma’s direct sponsorship of individual spots in residency programs. Do you suppose an "impulse to reciprocate" exists for sponsored lecturers, university consultants, and residency directors?

Almost 80 percent of clinical research is funded by Pharma, according to the AMA CSA Report from June 2004. Doctors get paid for referring patients into the studies — usually hundreds but sometimes thousands of dollars per referral — raising questions about selection bias and reinforcing our dependency on the industry. Institutional review boards (IRBs) may have as many as 50 percent of their members who have financial ties to the industry (AMNews, 9/20/03). NIH researchers are frequent Pharma consultants, and the NIH itself receives funding. All these and other examples at least lead to questions of divided interests.

Research is published in journals, many of which are heavily dependent on Pharma money. Does consideration of a journal’s budget influence an editor on what and when certain studies get published? And authors with financial ties to Pharma supported certain drugs 96 percent of the time vs. authors with no such ties who did so only 37 percent of the time (JAMA, 1/03). Phase IV trials rarely publish negative outcomes, and even the favorable reports tend to appear in the less-than-mainstream, peer-reviewed journals. A report from Copenhagen showed that an experimental drug was recommended 16 percent of the time when the study was funded by a nonprofit, 30 percent of the time when the funding was unknown, and 51 percent of the time when funded by a for-profit company (JAMA, 8/20/03). Publication and author bias exists and is poorly recognized by our peers.

Several reports, including Sager and Angell, show that Pharma’s R&D funding rose from 11 percent of their budget to 14 percent from 1990 to 2000, but, during that same period, marketing and administration rose to 36 percent and profit to 18.5 percent. Prescription drugs (excluding the burgeoning supplement/alternative medicine market) now consume over 11 percent of the health care dollar, which was below 8 percent a decade ago. That difference is nearly $60 billion per year. I am sure no one would suggest such a proportion is bad as long as we are getting more value for the increase, but it does mean that that much less is available to pay for other things, like physicians and hospitals. Do we get $60 billion per year more value?

Unfortunately, in 2002 only 17 out of 78 new drugs were truly new forms of therapy. The others were copies of existing, available treatments. That percentage of truly new drugs is shrinking. For the five-year period preceding 2002, it had averaged 32 percent. Patents are an important and necessary government-blessed "monopoly" designed to foster innovation. But, in 1980, legislation specifically allowed new drugs to obtain patents if they could show that they were merely better than placebo (and could document safety), not that they were innovative or an improvement over what was already on the market, the usual yardstick for patents in other industries.

The clock on patent life starts when an application is filed, not when a drug goes to market, creating pressures for earlier and earlier release. Patent life was extended by three years with the Hatch-Waxman Act of 1984, a bill to make it easier for generic medications to get to market. The three-year patent extension was the "deal" with Pharma to get the bill passed. Patent length is the same for the sixth drug in a class as it is for the first. Companies about to lose huge revenue when a patent expires create "new and improved" versions (Nexium for Prilosec, Clarinex for Claritin) to attempt to hold onto their market share. Patents are granted even though, as in the case of Clarinex, it is exactly the same chemical, just one step along the metabolic pathway once absorbed. Finally, companies petition to change their drug to OTC, which by existing law then allows another three years of patent/monopoly. I will suggest later that this existing regulatory system could serve doctors and their patients better if changed somewhat.

So we have a very successful industry behaving absolutely legally to create life-saving and life-improving "new" treatments. But fewer than one-third of the new treatments are new, and they successfully create the disease, they create the market, pay for the research, educate the prescribers at all levels of education; they contract with those who make the formularies and pay for a part of the budget of the agency that regulates them; and they successfully lengthen their patents with legal challenges to competitors, "Me-Toos," and with OTC conversions. So, we get Nexium and Clarinex and less of the health care dollar for physicians and hospitals.

The scope of this article does not allow a discussion of what I consider things not to do — like a single-payer solution or price controls — but I do want to outline 15 recommendations that should be part of organized medicine’s agenda. My goal is not to harm a very vital industry but to change the incentives that motivate it and us:

1. Start with ourselves as physicians, and take a "first step" that recognizes our financial dependency on the pharmaceutical industry, why the "drug rep" is there, and that they do affect our prescribing habits. CMA and AMA must help in this educational process.

2. Our AMA should seek a federal "Prescribing Privacy Act" — like CMA’s recently failed AB 262 — to outlaw the sale of our prescribing data to drug companies. What possible public good exists in their access to that information?

3. Our AMA should seek a federal "Truth in Advertising for Pharmaceuticals Act" for prescription and nonprescription drugs to make clear what can be said and what must be said, especially related to comparison to competitors and about risks.

4. Our AMA and CMA should urge universities, residencies, research centers, and clinics to bar drug reps and to allow doctors to see sales personnel if and when they choose.

5. Organized medicine must insist that CME never have agendas or speakers chosen or paid for by individual pharmaceutical companies. Sponsorships should be pooled through the CME coordinating organization.

6. Our AMA should seek to have all university, medical journal, FDA, and NIH funding from the pharmaceutical industry to be pooled, perhaps through Pharma itself, thus reducing any real/perceived obligation to any one company.

7. Our AMA should work with other nations to create an international registry of all clinical studies, which would mandate reporting of all findings, positive or negative.

8. Our AMA should seek federal legislation to require that those who participate on panels that approve drugs for use, including those in the FDA, hospital, and health plan formulary committees, and IRBs, must neither discuss nor vote on any drug if they have financial ties to a company that makes it or a related drug.

9. All of organized medicine should educate doctors and the public about the real savings when using generic drugs, fewer "Me Toos," and how that can painlessly pour money back into a system that needs it.

10. Organized medicine must educate doctors about OPM (other peoples money) as it applies to us — our free lunches, dinners, meetings, and pens do have a cost.

11. Our AMA should seek legislation to change the patent laws so that "Me Too" drugs receive a patent that expires at the same time as the first drug of its class. -OR-

12. Our AMA should seek legislation to change the patent laws to require that a new drug prove its advantage over existing drugs.

13. Our AMA should seek legislation to make it more difficult for a pharmaceutical company to mount legal challenges to competitor generic companies when their drug is coming off patent.

14. Our AMA should seek legislation to cease issuing of patents to "clone" medications (The Clarinex Act).

15. If it hasn’t already been done, our AMA should seek legislation to outlaw ownership of PBMs by pharmaceutical companies due to the obvious conflict of interest inherent in that ownership.

The influence pharmaceutical companies have on physicians’ prescribing habits is not all bad. Education of the public and of physicians about true advances in treatment clearly has its place. I have attempted to outline some of the problems I see in the way the system works now. I’m quite sure there are many, many other facets of this issue I have not touched upon nor thought of. I hope this begins a discussion that can improve the system; I hope this makes it more likely Pharma will create truly new and innovative treatments; and I hope physicians will choose more often what is in their patients’ and their community’s best interest. I appreciate any feedback you may wish to give.

Dr. Hay is a family physician in Encinitas, California. He was San Diego County Medical Society president in 2001 and is currently vice speaker of the California Medical Association House of Delegates. This article is reprinted from the April 2006 issue of the San Diego Physician.

1. Brennan T, Rothman D, et al. Health industry practices that create conflicts of interest: A policy for academic medical centers. JAMA. 2006;295:429-437.

2. Watkins C, Moore L, et al. Characteristics of general practitioners who frequently see drug industry representatives: national cross sectional study. BMJ USA, 2003;3:432-434.

3. Angell, Marcia. The Truth about the Drug Companies: How they deceive us and what to do about it. New York: Random House, 2004.

4. Sager A. "A Prescription Drug Peace Treaty: Cutting prices to make prescription drugs affordable for all and to protect research." Health Reform Program, Boston University School of Public Health, Oct. 5, 2000.

5. Avorn Jerry. Powerful Medicines: The benefits, risks and cost of prescription drugs. New York: Alfred A. Knopf, 2004.