The case is of special interest to me because of my personal experience with the question. It should be of interest to you if you ever consult with a physician who prescribes medications. I became aware of the issue before the court approximately fifteen years ago, while I was still practicing traditional family medicine. My story began much earlier, however, during my early medical training.

Medical school begins with the study of what are called the "basic sciences.” One of the basic science courses is pharmacology, the study of drugs – their composition, benefits, risks, and usage. My pharmacology textbook was Goodman and Gilman’s The Pharmacological Basis of Therapeutics, which was first published in 1941 and is currently in its twelfth edition. The Goodman and Gilman text presents a comprehensive and unbiased overview of the action and uses of drugs in light of the body’s physiology (functional design) and mechanisms of disease. It addresses drug classes rather than specific drugs within each class.

My pharmacology professors expressed hope that we students would continue to rely upon texts such as Goodman and Gilman to guide our prescribing choices upon our entry into medical practice. They bemoaned the fact that the vast majority of practicing physicians had the Physician’s Desk Reference (PDR) on their bookshelves and relied upon "Detail Men,” who were employed by pharmaceutical companies, to keep them updated on new drug developments. They pointed out that the PDR is not a scientific reference book, but rather a commercial volume in which drug companies pay to have their products listed. They were concerned that the Detail Men were more interested in promoting their companies’ drugs than in providing unbiased and helpful information about them.

The attitude toward drug information changed almost immediately upon leaving the classroom and entering the clinics and hospital wards where patients were seen. There the desks and bookshelves had PDRs, not pharmacology texts, on display and ready for use. There were practical reasons for this. PDRs are provided free by the pharmaceutical industry; copies of pharmacology texts are expensive (a copy of Goodman and Gilman today costs approximately $179). A textbook provides general principles about types of drugs; the PDR contains actual drug names, strengths, and recommended dosing regimens. New editions of texts are introduced approximately every ten years; a new PDR is released annually and quarterly updates are provided.

Detail Men were welcomed in the patient care settings for several reasons as well. First and foremost, they brought goodies – medical equipment (such as stethoscopes, reflex hammers, and blood pressure cuffs), food (morning doughnuts, mid-day lunches, and at times dinners), and tickets for amusement parks or other entertainment venues. Secondly, they provided samples of their products, which could be given to patients to evaluate the drugs’ effectiveness and ease prescription costs. Thirdly, they underwrote many student and resident activities. Finally, they provided prescribing tips they had "learned from other physicians” in making their rounds, and which they felt should be passed on.

Like my peers, I was proud of the fact that I was a scientific physician who kept up to date by attending continuing education seminars and by reading articles in medical journals. I was therefore, independently minded, and was not influenced in any way by the pharmaceutical industry (so I thought).

Little changed when I left the medical school campus and entered private practice. A new and expanded PDR arrived in the mail each January, right on schedule. I received complementary prescription pads, pediatric growth charts, and other items of value to my practice. There was little need to purchase office supplies, as my Detail Men kept me well-supplied with pens, note pads, calendars, mugs, facial tissues, clocks, staple removers, and a never-ending stream of other sundry items. Medical society meetings were attended by the Detail Men who had subsidized them. Lunches and occasional dinners were provided complete with speakers to keep me updated on the latest treatments, and there were drug samples in abundance.

Over time, I did observe some subtle (and not so subtle) changes. In the early days of my career Detail Men were generally, well, men. Those from Eli Lilly were actually required to hold a degree in pharmacy. Gradually, most middle-aged Detail Men were phased out and, more often than not, attractive young women took their place. That meant, of course, that companies were no longer sending Detail Men to my office, but rather "Pharmaceutical Representatives.”

At first, each company assigned one representative to my office. He or she represented all of that company’s products. Over time, representatives began to specialize. Each company had a "cardiovascular” representative, a "neurological” representative and so on. Soon each product had its own assigned representative and not long after multiple representatives for each drug began to call. Had I not limited the number to four daily (two after each morning session and two after each afternoon session) my entire schedule could have been consumed by visiting drug reps. I was tempted to stop seeing all pharmaceutical representatives, but I was hooked on their samples. I had been taught that patients expect drug samples and the price for obtaining samples was indulging the person who brought them.

Things changed the day a young, aggressive pharmaceutical representative began his visit by scolding me for not writing enough prescriptions to adequately cover the number of samples he had left at the time of his previous visit. He was correct. In fact, I had not written any prescriptions for his product, but neither had I given out any of his samples. I was one of four physicians in the office and I assumed that the "uncovered” samples had been dispensed by one or more of them. I meekly accepted his brow-beating, but left the room with a burning question in my mind: How did he know I hadn’t written prescriptions for his drug?

A few days later, one of the surviving Detail Men whom I had known for many years and with whom I had a good relationship came by. I put the question to him. "How did the drug rep know whether or not I had written prescriptions for his product?”

After looking warily from side-to-side the Detail Man sat down, pulled a laptop computer from his briefcase, opened a program, and typed in my name. "I’m not supposed to show you this,” he began hesitantly, "but I receive regular updates on which prescriptions you’re writing. The data is collected from pharmacies all across the country. It doesn’t matter where the prescription is filled. You might write the prescription here in Edmond, Oklahoma, and the patient may fly to San Diego, California before having it filled. I’ll still know about it.”

He showed me my profile. He knew far, far more about my prescribing habits than I did. He could in an instant tell me how many prescriptions I had written for drugs in any specific class. He could tell me how many prescriptions had been written for his drug and how many had been written for drugs of his competitors. He knew how many of my prescriptions had been purchased through a prescription drug plan, how many through Medicare or Medicaid, and how many patients had paid for them out of their own pockets. The data showed what percentage of my prescriptions had been written for patented brand name drugs and how many had been filled generically.

"Where did you get all that information?” I asked incredulously.

"My company contracts with an agency that gathers prescription data from pharmacies across the country,” he replied.

"Isn’t that an invasion of privacy?” I asked.

"No, not at all,” he responded nonchalantly. "All of the identifying patient information is removed before the data is sent to us.”

"I’m talking about my privacy!” I retorted.

"You’re a physician,” he answered. "You don’t have a right to privacy.”

The issue was settled. It was obvious that I could do nothing to prevent drug pushers from obtaining sensitive information about my prescribing habits, which they could use to tailor their sales pitches to me. I couldn’t stop them from obtaining the information, but I could ensure that it would be of no value to them. I could refuse to see them, and I could stop using their samples.

As I stated earlier, I considered myself immune to the wiles of the pharmaceutical industry. I truly believed that I was basing my treatment decisions upon unbiased journal articles and presentations at scientific assemblies. In spite of my supposed "independent thinking” something amazing happened when I stopped accepting visits and samples from drug pushers. I became an "outlier” in the eyes of the health insurance industry.

An outlier is something that doesn’t fit a standard or expected profile. In the case of a provider of medical services (the insurance industry doesn’t use the professional term "physicians,” it prefers to call them "health care providers”) an outlier is someone whose profile falls outside of the expected norm. In my case, I was suddenly considered a sub-standard physician because my prescribing habits fell so far below the norm both in terms of the number of prescriptions written and the cost of the drugs prescribed.

Managed care organizations (HMOs, PPOs, etc.) track the same data used by pharmaceutical companies to promote drug sales, but they use it in a different manner. The insurers are interested in holding down prescription drug costs, so on one hand they want to see that their providers are not prescribing too many drugs. On the other hand, however, they want to be assured that their subscribers are being treated appropriately; they expect their providers to prescribe enough drugs to demonstrate that they are giving competent care.

Based upon my new prescribing habits, the quality of care I was providing to my patients was suspect. Not only was I not writing enough prescriptions, but the cost of my prescriptions fell far below that of other physicians in the program. I did not save the reports that were sent to me at the time, but the following numbers are close approximations. If the average number of prescriptions being written per member per month was 2.3, I was writing well less than 1. If the average cost of prescriptions per member per month was $45, the cost of my prescriptions was closer to $7.

At least two things accounted for the decline in the number of prescriptions being written. One was that I had begun to encourage people to support their bodies’ healing ability with lifestyle changes and nutritional supplements rather than to attack their bodies with drugs. The other was the absence of pharmaceutical representatives who had been encouraging me to prescribe specific drugs on a regular basis.

The dramatic decline in prescription drug costs was easy to explain. It was due to my refusal to offer drug samples to my patients. In most cases, a number of drugs are available for and equally effective in treating an illness. Only those drugs that are still patent-protected are sampled by drug companies. Therefore, only the highest priced drugs are found in a physician’s sample cabinet. When I stopped providing samples to my patients I no longer felt compelled to prescribe a new, improved, and premium-priced drug rather than an old, reliable, and low-priced generic option that would do the job effectively.

The case before the Supreme Court concerns a law passed by the Vermont legislature in 2007. It prohibits the sale, transmission, and use of prescriber-specific data for marketing purposes unless physicians first give their permission. Data mining firms, including IMS Health, SDI, and Source Healthcare Analytics, along with the Pharmaceutical Research and Manufacturers of America (PhRMA) were successful in having the law declared unconstitutional by a federal appeals court in New York City after initially losing their case in federal district court in Brattleboro, Vermont. The data mining companies argued that the law violated their First Amendment right to "commercial" speech and that it jeopardized patient safety because pharmaceutical representatives use prescription data to educate physicians on how to best use their products.

The State of Vermont appealed the ruling, and that is why it is before the Supreme Court. Groups that have filed briefs in support of the Vermont law include the Obama administration, a coalition of 35 states, an organized-medicine coalition that includes the Vermont Medical Society and the American Academy of Family Physicians, the Electronic Privacy Information Foundation, and the AARP. Interests submitting briefs in support of the data mining companies include the Association of Clinical Research Organizations, the Associated Press, the Hearst Corporation, a coalition of advertising trade groups, a collection of biotechnology organizations, and the US Chamber of Commerce.

An argument made by PhRMA would be laughable were the issue not so important. Vermont lawmakers, it stated, "expressed a paternalistic attitude that doctors cannot be trusted to make the best treatment decisions for their patients unless the State filters out truthful information." (Italics mine.) What, I must ask, is truthful about obtaining detailed information about a physician’s prescribing practices without the physician’s knowledge or consent and using that information to influence the physician’s choice of treatment options? Perhaps an even more important question is, "What is the "best treatment decision” for a patient? Is it one made by a physician based upon his or her training and experience, or is it one made by a physician who has been unduly influenced by a drug company representative who was able to prepare a sales presentation specific to the physician’s own prescribing record?

PhRMA also suggested that physicians do not need any help from the government in coping with drug reps. Their brief stated. "Doctors can and do refuse to meet with sales representatives." True, but they are few and far between. I suspect, at least I hope, that many more would refuse to see them if they knew that detailed information about their prescribing practices was being skillfully used to convince them to prescribe specific drugs.

Now that you know the truth about drug detailing, pharmaceutical representatives, and drug sampling you have the opportunity and ability to take matters into your own hands, as I did when I learned it. If you are in the process of selecting a physician ask whether he or she sees drug reps and accepts drug samples. If possible, find a physician that does neither. If your current physician does see reps and dispense samples, don’t be afraid to ask if an older, less costly drug is available when you are given a prescription to treat your condition.

The case in which an off-patent option is not available is rare, although the FDA has begun to offer exclusive marketing licenses of generic drugs to companies that are willing to pay the high price of filing a new drug application with them. An example is colchicine, a drug that until recently was available generically for 10 – 15 cents a tablet, but is now available only through one FDA-approved manufacturer who is charging in the range of $16.00 per tablet.

It is not surprising that the pharmaceutical industry is fighting to overturn the Vermont law. In 2005 the industry spent $7.2 billion on marketing to physicians. This included medical journal advertising, sponsorship of medical meetings, and physician visits by pharmaceutical representatives. The most cost effective means of influencing physician prescribing was aggressive face-to-face "detailing.” A 2001 Dartmouth study revealed that every dollar spent on a focused, personalized presentation to a physician generated $10 in sales of the drug being marketed – I’m sorry, I meant to say "detailed.”

I told my story because I do not believe that I am unique. I am certain that most physicians are blissfully unaware of how much their prescribing habits are being influenced by the pharmaceutical industry. Few realize that their prescription data is being mined and sold for use by those whose job it is to convince physicians to prescribe certain drugs. Unless the Supreme Court upholds the Vermont law, it is unlikely that anything will change. With major media organizations supporting the data mining companies I don’t expect to see an expose` of the practice anytime soon.