The technique of advertising drug and device treatments directly to the consumer received some close scrutiny last month in the New England Journal of Medicine, with articles examining the increases in this type of advertising and raising warnings concerning the impact of this growing marketing strategy.In one article, two Harvard (Cambridge, Massachusetts) researchers point to the direct-to-consumer (DTC) marketing of computed tomography scan techniques for diagnosing arterial disease and some forms of cancers. While noting that these tests are receiving aggressive promotion to patients and potential patients, the researchers charge that these methods of assessment are not supported by a large body of solid evidence for their use as screening tools.

While authors Thomas Lee, MD, and Troyen Brennan, MD, document the growth in this type of marketing approach, they say they have "serious reservations about the clinical, financial and ethical implications of offering these tests as screening interventions."

The journal provides even more space to researchers at Harvard's School of Public Health who document the significant increase in drug advertising, noting a more than tripling of spending on direct-to- consumer drug ads from 1996 to 2000 — from $800 million to $2.5 billion.

What may be surprising is that this is not a particularly dramatic increase in terms of overall drug marketing, which still remains largely focused on physician consumers. The article cites $13 billion spent by drug companies in professional marketing materials such as free samples ($8 billion) and in-office promotions ($4 billion). Overall, the authors estimate that direct-to-consumer ads have risen from 1.2% of overall sales in 1996 to just 2.2% of sales in 2000.

The increased direct-to-consumer efforts get both praise and brickbats from industry watchers, the variety of reactions depending largely on their baseline points of view. Those representing the pharmaceutical industry argue that consumer advertising tends to encourage doctor-patient discussion of a broader range of therapeutic options. That view is supported by a recent study sponsored by Pfizer (New York), which said that DTC advertising improves the quality of patient visits to a doctor, those findings drawn from a physician survey. According to Market Measures/Cozint (Hanover, New Jersey), which administered the survey, physicians said that DTC advertising prompted more patient visits by "appropriate" patients. About 70% of the patients said they felt no pressure to prescribe medication requested by patients who saw a DTC advertisement, and more than 80% reported that the drugs discussed were appropriate for the patient.

Not unexpectedly, patient activist organizations have expressed fears that direct-to-consumer marketing may result in promoting the over-use of medications by susceptible groups unable to distinguish between fact and advertising verbiage. They also note that the sale of pharmaceuticals is currently the fastest growing segment of the health care spending pie.

Overall, however, the direct-to-consumer pitches aren't pushing a broad range of drugs, the NEJM article points out, since the drug makers don't have unlimited budgets for marketing every drug. The bulk of the advertising dollars — about 60% — is focused on a fairly narrow group of 20 drugs. Another finding of the report is that a 1997 clarification of drug advertising policies by the FDA resulted in a clear shift in the advertising media used by the drug companies — primarily from magazine advertising to television.

Endoscopic neck surgery reported

The surgeon's signature, unfortunately, is too often a scar, and one fairly obtrusive following surgery of the neck. Now, Stanford (Palo Alto, California) researcher David Terris, MD, has reported on a new endoscopic surgery technique that, utilizing three small openings and using high-pressure carbon dioxide to hold the skin and other organs away from the surgical field. "This makes surgery more tolerable and provides a way to remove tissue without leaving a surgeon's signature behind," according to Terris, associate professor of surgery at the Stanford University School of Medicine. "Anything we can do to minimize or hide a scar is doing patients a favor."

Experimental endoscopic neck surgery in pigs — their anatomy being similar to humans — has shown to have major problems, primarily the result of carbon dioxide bubbles leaking into the bloodstream and can cause stroke, Terris notes. He says that this is not a problem in stomach surgery, where the carbon dioxide does not escape. "There's no such sac in the neck, so we had to develop a way to create a pocket to work in without sending the gas elsewhere," he said. To do this, Terris and his team inserted a balloon under the skin of the neck to create an opening, then blew gas into the opening at low pressure to hold the space open. Testing their strategy in pigs, no gas leaked into blood vessels and the operations went smoothly.

The procedure was then performed on a male patient with an enlarged lymph node needing biopsy. Because of a previous medical procedure, the patient was on immune-suppressant drugs that slow the healing process and increase the risk of surgical infection. Terris said the surgery took longer than normal, but the patient was able to go home that night. A half-inch scar and two quarter-inch scars near his collarbone, covered by clothing, were the only sign of the procedure. The scars are below the collar and are fully covered by ordinary clothing.

Terris said he expects endoscopic neck surgery to be widely used, initially for removing "lumps and bumps" and, when definitely proven safe, for more major procedures.

Study eyes perception of dyspnea

Perception of dyspnea (POD) is defined as the identification, evaluation and interpretation of discomfort of breathing. Researchers have found that asthma patients with a low POD, or in more common terms, shortness of breath, had significantly increased visits to the emergency room, hospitalizations, near-fatal asthma and death as compared to those with normal or high POD.

A new study conducted at the Hillel Yaffe Medical Center (Hadera, Israel) measured the POD in 113 patient subjects with stable asthma and related it to the incidence of near-fatal and fatal attacks within a two-year period. Results were compared with the PODs of 100 healthy matched subjects.

In a report published in Chest, the journal of the American College of Chest Physicians (ACCP; Northbrook, Illinois), those researchers said that patients with a low POD had significantly increased visits to the emergency room, hospitalizations, near-fatal asthma and death as compared to those with normal or high POD.

"Preventing a life-threatening attack, and certainly death, is a major concern in the ongoing treatment of asthmatic patients," said Paltiel Weiner, MD, head of Department of Medicine A at Hillel Yaffe Medical Center. "POD is not readily measured in the treatment of asthmatics today, but with a simple test, we can identify patients with low POD, those with risk for fatal asthmatic attack. By carefully monitoring them, we can prevent death from asthma."

In the Israeli study, about 26% of the subjects had low POD, as compared to 59% with normal POD and 15% with high POD. The researchers found that asthmatics with low POD, even without a history of near fatal asthma, were more likely to suffer life-threatening attacks. Low POD subjects tended to be older, female, be a longtime asthma sufferer and have severe asthma.

ACCP President Sidney Braman, MD, said the study "has important implications for our role as clinicians. Impaired perception of dyspnea should be considered in all high-risk asthmatics, and if found, such patients can be monitored more closely."

Tanning, skin cancer risk established

In a study whose results came as no great shock to its authors, the use of tanning beds and tanning lamps was linked to increased risk for skin cancer, according to a report in the Journal of the National Cancer Institute (Feb. 6, 2002, issue). Lead author Margaret Karagas, MD, of Dartmouth Medical School (Lebanon, New Hampshire), and colleagues interviewed about 900 people, about two-thirds with basal cell carcinoma, and a third with squamous cell carcinoma, and compared their results with a control group of 540 people who were cancer-free.

Factoring in previous exposure to the sun and general sensitivity to sunlight, they found that those who used a tanning device were two and one-half times more likely to develop the squamous cell type of cancer and one and one-half times more likely to develop the basal cell type of cancer. 603 people with basal cell carcinoma, 293 with squamous cell carcinoma and a control group of 540 cancer-free individuals. Previous research had indicated a relationship between tanning lights and increased instances of melanoma, but this is the first study to demonstrate the relationship to other forms of skin cancer.

A general trend was that the younger a person used a tanning device, the greater their risk, at a rate of about 20% per decade for squamous cell cancer and 10% per decade for basal cell cancer. The risk was also greater for women, with previous studies showing that half of all high school girls in the U.S. use a tanning bed about four times per year.

Saying she was not surprised by the results, Karagas promised additional studies on the issue and indicated that these are likely to support public policy that involves strong health warnings about the devices and perhaps even preventing their use by teens.

Computer games not entirely safe either

Another group of devices popular with young people also should be accompanied by alerts concerning their risk, according to a new study indicating that certain types of computer games can damage hands. A letter in a recent issue of the British Medical Journal described the case of a 15-year-old boy who had used a computer with vibrating controls and had developed hand-arm vibration syndrome, ordinarily the result of using industrial tools over an extended period. The boy developed swelling and pain in his hands after reportedly using the game device up to seven hours a day. The letter noted that the boy's use of the device exceeded the recommendation by the manufacturer, but added, "we must assume that this is not an uncommon occurrence."