How Doctors Think (29 page)

"It didn't make sense that nature could be so wrong," Delgado said, talking about the steady decline in hormone levels in women after menopause. "It didn't make sense that every woman should be on the same medication. You have to look at each patient as an individual and assess what is best as a preventive." A one-size-fits-all approach to prescriptions was flawed. Although Delgado felt vindicated by the Women's Health Initiative, the NIH-sponsored trial of hormones versus placebo in postmenopausal women, it seemed like common sense to her that a single hormone could not return a woman to biological youth.

Delgado does not consider the Women's Health Initiative an absolute condemnation of estrogen. She still treats women who she believes might benefit from hormonal treatment. "You have to weigh the information," she told me. "You assess the risks and then make a tradeoff." For example, she had recently seen a woman, entering menopause with incapacitating hot flashes, whose mother had had breast cancer. Estrogens are known to promote cancer of the breast, and such a family history is cause for concern. But the woman had such severe symptoms that she could not work or socialize. "I recommended she take estrogen to tide her through this period," Delgado said. She explained in detail to the patient the tradeoffs involved before recommending the hormone treatment, emphasizing that breast cancer could develop even with close monitoring. Furthermore, she hoped that the hormone could soon be discontinued. It wasn't an easy decision, not a simple tradeoff, but such choices rarely are simple.

So for women like this with severe, acute symptoms of menopause, Delgado prescribes estrogen for short periods until the change of life passes. Then, unless there is a clear need for continued treatment and no alternative, she stops. "Hormones are not the fountain of youth," Delgado said, no matter how they are depicted by the media and some physicians. To believe that a hormone like estrogen can prevent most of the consequences of aging, such as heart disease and memory loss, "simply makes no sense," she told me. The biology of aging involves many physiological systems, changes in many molecules. Fixating on a single molecule like estrogen as a remedy is naïve and, as the Women's Health Initiative study showed, potentially dangerous. "There is a powerful temptation felt by patients and doctors alike to have a simple answer to complicated problems," Delgado concluded.

Douglas Watson was an executive in the pharmaceutical industry for thirty-three years, rising to be the president and CEO of Novartis Corporation, the U.S. subsidiary of Swiss-based Novartis AG. I spoke with Watson to gain the perspective of an experienced pharmaceutical executive whom I knew to be ethical and data-driven. Watson hails from Scotland and has the straighttalking, direct manner that characterizes so many of his countrymen. He studied pure mathematics at Cambridge University in the United Kingdom and then rose through the ranks of large pharmaceutical companies until his early retirement from Novartis in 1999. Watson had once made a statement that caught my attention: if a new drug signals a significant improvement, either in its efficacy against a clinical condition or in its safety profile, with fewer side effects, then statistical gymnastics should not be needed to persuade a doctor to try it. "My goal in terms of marketing is to have a physician try a new therapy in one or two of his patients—and I mean one or two, not in hundreds," he told me. "We would want the physician to have a positive experience with the drug, to see its benefits for these one or two patients. That way, he would become comfortable in learning how to use it appropriately, and incorporate it into his standard of care."

Watson said marketing studies show that most physicians routinely prescribe only around two dozen drugs, and that the majority of these drugs were adopted during their medical training or shortly thereafter, even if that training occurred decades earlier. Most practicing doctors like to feel in control of their treatments, and that sense of control is derived from long-term experience with a particular drug. In fact, there often is no need to prescribe the latest drug for hypertension or arthritis, for example, because most new therapies for these maladies are either "me too" agents that are substantially similar to their predecessors or they represent only a small increment in benefit rather than a marked advance. "There may be one or two generations of products that offer 'marginal improvement'—my words for these kinds of new drugs—but the experienced clinician rightly relies on his golden oldies and still delivers appropriate care." Watson laughed. "I can see two perspectives on this. As a businessman, it can drive you nuts, because I want to sell you a product. But as a patient myself, it makes perfect sense, because usually I don't need the latest and greatest drug to improve my health.

"Patients' satisfaction with the relief they get from arthritic pain with anti-inflammatory agents is very low," Watson continued, "a subject, Jerry, that I know is close to your heart." He was familiar with my long-standing difficulties with low back pain. "When a new arthritis drug is developed, there is a very rapid penetration of the market, because people say, 'What I'm on now isn't doing a very good job, so I may as well give this new drug a try.'" Usually within six months, Watson said, nearly the entire market share that this new anti-arthritic agent will capture has been captured. "Everyone and their sister run down the road to their doctor and say, 'I saw this ad on the TV for Celebrex or Vioxx.' And," Watson continued, "the doctor, aware that the patient's arthritis was not being meaningfully ameliorated, is ready to prescribe the new drug." If the advertisement were for a blood pressure medication, then, Watson said, "today's drugs, not to mention yesterday's drugs, control blood pressure quite well for the vast majority of people," so a doctor is less willing to try a new agent, even if a patient requests it.

Watson sees testosterone replacement therapy as an example, like Viagra, where the pharmaceutical industry is capitalizing on a cultural shift. "Sexual function was not a dinner table conversation when I was growing up," he said. "Even twenty years ago, I am not sure that you would have seen the social expectations around sex being what they are today. Testosterone, Viagra, and other drugs being prescribed are driven by the change in society, and men's usage overall has very little association with the word 'need.'" Watson admits with a laugh that when Viagra was in development, he didn't realize its full potential. He had in mind the relatively small number of men who'd had damage to the nerves of their penis or had pelvic radiation or surgery. He did not anticipate the large numbers of men who would take the drug, not for such a clear medical indication, but recreationally. "Who would have predicted that Bob Dole gets on the TV and talks about it?" The ads featuring Dole, in Watson's view, caused a dramatic change in the public and a ripple effect among physicians, resulting in Viagra's multibillion-dollar revenues. If a respected war hero from Kansas, whose politics were generally conservative, with a dynamic, glamorous wife, could advocate such a drug, then anyone could feel comfortable using it to improve his own sex life. The major difference between testosterone and drugs like Viagra is that Viagra produces a clear physical result, a sustained erection, while the studies on testosterone often show no enhanced libido compared with a placebo.

When I asked Watson for his definition of "ethical marketing" of drugs, he replied that the primary aim of marketing should be the accurate education of a physician in the side effects and potential benefits of a particular agent. Most doctors, he said, learn about new products from the pharmaceutical industry. "The physician who takes the time and effort to go read in depth about a new drug is the exception to the rule," he allowed, and studies support this contention. For that reason, he believed that busy doctors with scant time to dig into the data on their own should be given educational materials that position the treatment in its correct clinical niche. "A good sales rep will focus the physician's attention on what are the critical issues around the drug, and then the doctor, hopefully, will take the time to read the package insert and other materials that the drug rep leaves behind, again focusing on what's key." As opposed to simply selling, the industry should help in physicians' education.

"I'm not trying to pretend that we are not selling, because we are," Watson said. "But the ethical company with a good product should be primarily trying to teach the physician how to use it." There is financial self-interest in this approach, of course. With a better understanding of the drug, a physician is more likely to "give it a try," Watson said. And try it correctly. "We want a good product to be given to the right patient. Because if it's not prescribed properly, then either it doesn't work or it has unexpected side effects, and that's the last thing we want, for the patient's sake and because it will turn off the doctor.

"Some doctors, frankly, are weak-willed wimps, so when a guy comes in and says he has a pain in his knee, and the doctor is scared that the guy is going to go down the road to another doctor if they don't give something, they write a prescription—and you can fill in the blank for whatever is the latest drug that's been advertised," Watson told me. Other doctors, in response to advertisements directed to the public, Watson continued, "say to themselves, 'Well, he wants this drug, I might have prescribed something else, but it really doesn't make much difference, so I will give him what he wants.'" It is in this "public-driven" arena, Watson said, that you see "real marketing," the effort by certain pharmaceutical companies to create demand for products that don't merit it based on a medical need. Watson's words brought to mind the expensive pills advertised for indigestion when common antacids are equally effective for most people at a fraction of the cost. Contrary to the branding of many pharmaceuticals, Watson asserts that most generic drugs are equally safe and effective and offer great cost savings. But companies market aggressively against generics and try to mold a doctor's behavior with gifts and perks. "I can tell you, if a doctor prescribes an overly expensive brand drug for me because some salesman gave him a Mont Blanc pen, that is not the kind of doctor I would want."

Shortly after my conversation with Watson, I spoke with a surgeon I know. As it happened, he was leaving the next day for a skiing trip in Colorado to attend a medical conference. The entire cost of the trip—air fare, hotel, food, and registration for the meeting—was paid for by a company that makes a surgical device he frequently uses in the OR. This was not a Mont Blanc pen. The trip was worth thousands of dollars.

"I don't think this will influence me to use their product any more than I do," the surgeon insisted. I told him I was skeptical. "In fact," he replied, "I split my work right down the middle. Half the time I use this company's instruments, and half the time I use their competitor's." He laughed, saying that by keeping each one at bay, he would get more perks.

What he didn't mention was whether some of the surgeries he performed with either product were necessary in the first place. Sometimes high fees for a particular operation, combined with the largesse of a device company, appear to drive up the number of unnecessary surgeries. Spinal fusion is a prime example.

A historical perspective helps in understanding the controversial subject of surgery for chronic back pain. Surgeons have touted a long list of procedures that ultimately proved disappointing, if not ineffective. In the 1950s, many patients with angina and coronary artery disease underwent an operation that involved tying off an artery that runs under the breastbone. At the time, physicians believed that the procedure would increase blood flow to a heart starved of its normal supply by blockages in the coronary arteries. Then, at the end of the decade, a clinical trial showed that patients who had a sham operation did just as well as those who had the real one. Apparently, the placebo effect accounted for the fact that many patients felt better after the surgery.

Other once popular procedures resulted from a misunderstanding of the biology of a particular condition. William Halstead pioneered the radical mastectomy in 1895 at the Johns Hopkins Hospital; it became routine therapy for breast cancer. When I was a medical student at Columbia in the early 1970s, no one questioned it. Surgeons throughout the country believed that breast cancer spread in a contiguous, stepwise fashion from the primary tumor and that the only cure was to remove the entire breast and underlying muscles. By the 1980s, it had become clear that tumor cells can spread throughout the body early in the disease through the lymph channels and blood vessels. A lumpectomy, which involved excising the tumor and preserving the breast, followed by radiation to the affected area, proved as effective as a radical mastectomy in treating the cancer and was much less mutilating and traumatic for the patient.

Spinal fusion may be the radical mastectomy of our time. In 2006, more than 150,000 lower lumbar spine fusions were performed in the United States. The operation involves removing discs from the lower spine and mechanically bracing the vertebrae with metal rods and screws. The procedure is of tremendous benefit to patients with fractured spines or spinal cancer, but these make up a minuscule number of the total cases. More frequently, spinal fusion is performed to alleviate chronic low back pain. There are serious questions about whether the operation is effective and why some doctors perform it.

CT and MRI scans are often used to make the case for surgery, but the correlation between damaged or degenerated discs and low back pain is poor. For example, studies have shown that 27 percent of healthy people over the age of forty had a herniated disc, 10 percent had an abnormality of the vertebral facet joints, and 50 percent had other anatomical changes that appeared significant on CT scans. Yet none of these people had back pain. Similar results were found in a study using MRI scanning: 36 percent of people over sixty had herniated discs, and some 80 to 90 percent of them had significant disc degeneration in the form of narrowing or bulging. Again, despite significant anatomical changes in the lumbar spine, these healthy people had no nagging back pain. For some people, of course, the rupture of a disc coincides with the acute onset of pain. But even then, studies show that surgery is often unnecessary. More than 80 percent of people will recover with conservative measures, like anti-inflammatory medication, a short period of rest, and then progressive mobilization and physical therapy. A simple operation called a discectomy—shaving off the lip of the disc that has herniated and that presses on the nerve root—can relieve pain more rapidly; those who wish to avoid an operation can do so, but they may be uncomfortable for a longer time.