Just What the Doctor Ordered

Direct-to-consumer drug advertising is putting a different spin on doctor/patient relationships.

“The desire to take medicine is perhaps the greatest feature which distinguishes man from animals.”
—Sir William Osler, The Father of Modern Medicine

OK, Sir William Osler died long before somebody in the movie “Steel Magnolias” uttered the line, “The only thing that separates us from the animals is our ability to accessorize.” I never actually saw the movie, but I can say this: Anybody who’s spent 20 minutes trying to get a cat to take a pill is going to side with Osler.

There’s no escaping ads for prescription drugs. Whether it’s a cartoon character portraying the common cold; or Abe Lincoln, a space invader and a beaver all playing cards with a guy who can’t sleep, the ads are omnipresent. Convincing consumers they should ask their doctors to prescribe drugs to treat everything from depression to erectile dysfunction (not that those two conditions are linked) is a $5 billion annual business. And when you stop to consider that, in 2005, Americans forked over $251.8 billion to curb, control or cure maladies, it’s easy to understand why 29 percent of the ads on network TV are pushing drugs.

Put another way, aside from cars, no product is actually advertised on TV more often. This is to say nothing of magazines where Crestor, Nexium and Lunesta are slugging it out to become the country’s favorite treatment for cholesterol, heartburn and insomnia, respectively.

Why do we spend so much? The oversimplified answer is that we’re Americans; we buy stuff, even when we have to convince a doctor to let us buy it. Also, we like our technology, and taking a drug is like pushing a button to make something change—it isn’t much effort and it happens right now. To a large degree, it’s easier to take a pill than follow a strict regime of diet and exercise to cut back cholesterol. “People like an easy fix, something that doesn’t require too much effort,” says Dr. Leonard Klay, a semi-retired Sonoma County physician who remains active in policy study. “I’m not saying people are lazy, but the ads bring people in who expect that taking a pill will take care of the problem easily.”

The United States isn’t alone in its favor of the easy road, but it is one of only two English-speaking countries in the world that let drug companies run ads singing the praises of their products. The other is New Zealand. And if you’ve ever spent a Saturday night in a bar with New Zealand rugby players talking, quaffing beer and singing, you might debate that “English-speaking” part.

Those on the inside of the medical community refer to the ads as “direct to consumers” (DTC) because they’re designed to skip the traditional pharmaceutical companies’ targets—doctors—in favor of you and me. Though many of us have gone to college and have a reasonable amount of intellectual capital, most of us would have tough time picking a liver out of a police lineup. On the other hand, physicians have often spent years studying medicine, a pursuit that surprisingly brings them in close contact with sick people and drugs on a fairly regular basis.

Go figure.

The cutting out of the white-lab-coated middleman with the initials M.D. resulted from a combination of bottom-line worries and a health problem—marketing to docs was costing companies too much money and physicians were sick and tired of drug company reps. For years, drug companies spent gobs of cash courting docs with everything from Caribbean junkets to ski vacations in the hopes the doctors would think of their drug first when it came time to prescribe.

In some ways, the fight for the hearts and minds of physicians took on the look of an arms race, with companies like GlaxoSmithKline plc and Pfizer adding sales staff at a maddening pace. But medical ethicists and the FDA began to wonder if a trip to St. Barts might not influence a doctor to write a ’scrip for a drug manufactured by the same company who’d paid for the island “conference.” And doctors have soured on wading through sales rep presentations at the expense of treating patients, despite the free lunches and giveaways that traditionally accompanied such visits. Stanford Medical Center has taken to banning giveaways and drug company presentations. And a 2004 survey of doctors found just 40 percent trusted drug companies.

In 1997, the Food and Drug Administration relaxed its regulations regarding drug ads, dropping the need for lengthy explanations of possible side effects. Almost overnight, a billion dollar industry was born, along with a fear by consumers of everything from yellowing toenails to not sleeping eight hours a night.

 

Knowledge is power

Drug companies argue the ads and commercials are educational tools meant to give consumers more information regarding health issues. Indeed, there is some evidence consumers feel some ads present information that otherwise might not find its way to them. Studies of the ads’ effect on consumers show one of the positives cited is education. But many doctors dispute the education angle. “The commercials are advertising, and people need to treat the [prescription] ads as they would any other product,” says Dr. Sharon Levine, the associate executive director for Kaiser Permanente Northern California.  “Doctors are concerned with people confusing product promotion with education. These ads are about brand recognition. People need to view them with thoughtful skepticism.”

Levine sees the big picture; practicing medicine for 33 years will do that for you. “The advertising for drugs that treat depression has helped from the perspective that depression is a silent disease and the ads have promoted some discussion of it and its treatments and have made more people aware of it.”

Still, doctors have a right to be concerned about the flood of ads and how it changes patient expectations. A May 2004 study by UC Davis Dr. Richard Kravitz and others showed that actors posing as patients complaining of depression were prescribed Paxil 53 percent of the time when they asked for it. When the actors just asked for a prescription, they received one 76 percent of the time, and 31 percent of the time when they didn’t ask at all.

It’s no accident that the three-month-old magazines found in your doctor’s waiting room are chock-full of drug ads. A 2003 study by the Henry J. Kaiser Family Foundation shows that in 2000, 12 percent of drug spending growth was related to increased spending on DTC, and for every extra dollar spent on prescription advertising by drug companies, revenues rose $4.20. Take that $1=$4.20 return on investment to your financial adviser and see what his reaction is. He may very well need a prescription for a sedative.

In the past few years, the debate in medical and political circles has heated up over just how much good direct-to-consumer ads do. In 2005, the American Medical Association rejected supporting a proposal banning the ads. Over the last 18 months, a number of bills have surfaced in congress exploring the idea of limiting the ads. But given the reality of how much money flows from political donations to Congress and the Senate, legislators can look good proposing things that will likely never see a vote, since their fellow lawmakers are unlikely to vote against those companies making the donations.

According to the Center for Public Integrity, since 1997, when drug ad laws were eased, the pharmaceutical industry has spent $675 million lobbying the federal government and another $87 million in political contributions. The lobbying total is significant not only from a standpoint of throwing lots of cabbage around, but also because many of those lobbyists are former lawmakers who, in a previous life, voted with and against the colleagues they’re now paid to drink scotch with and solicit votes from. In May 2006, 39 public health and consumer groups urged congress to ban DTC advertising. As you can see from watching the tube or reading magazines, those efforts fell on very well-paid-for ears.

That’s entertainment

Medical scholars, doctors and public health officials can debate the relative value of the endless commercials on TV, but there’s little debate on the entertainment value of some of the spots. And no drug is more entertaining than Levitra, the erectile dysfunction drug from GlaxoSmithKline.

Who can forget the introductory commercial: a middle-aged man struggles to throw a football through a tire hung by a rope from a tree, but alas, he can’t thread the needle. Time after time, the pigskin hits the tire and bounces off. The drug is mentioned and the trademark is flashed on the screen and suddenly our guy is Peyton Manning, pumping the ball through the tire ad nauseam, while a pretty woman gazes at his skills with a wide smile of anticipation before she joins him for a little nuzzling. The actual condition of erectile dysfunction is never mentioned, though the symbolism of the football penetrating the tire is enough to send porn star Jenna Jameson reaching for the remote. Since the condition is never mentioned, the drug company is under no obligation to mention the side effects.

In another Levitra commercial, a comely woman asks if you want to know a secret. The brunette explains in a sensuous voice that the drug improves her man’s experience, and that makes him want to do it more often, “For him, Levitra works—just look at that smile.”

I can’t say for sure if it’s the Levitra that has him looking like the Cheshire cat or the fact that the woman who wishes to share a secret is bouncing about clad in her man’s dress shirt and seemingly little else. Even as the couple makes eyes and embraces, the litany of possible side effects rolls out. They include headache, flushing, heartburn, nausea, dizziness, stuffy or runny nose, sensitivity of the eyes to light, high or low blood pressure, stiffness in muscles, pain in the joints, rash, or stomach or abdominal pain.

Ah, but those are the minor side effects, and only last as long the drug is in your system. In fact, the patient may not have any side effects at all. Or he may have to go to the emergency room with angina, an irregular heartbeat or loss of consciousness. Also, though it’s rare, an erection could last more than four hours, and if it does, the patient should seek medical attention.

This is where the train leaves the track. I think I speak for men everywhere when I say that if I have an erection that lasts four hours, the doctor is the last person I’ll be visiting. If the Little General is in command for four hours, I’m calling everybody I know and getting video.

As for the list of possible side effects, they’re nice to have but not complete. For instance, while it’s good to know that I may turn my mate off by vomiting or sprouting an unsightly rash during sex, it would be more valuable to know how Levitra is going to affect my ability to reason. For years, men have run into trouble because of a lack of blood to all vital organs just prior to and during sex. I think we’d pay extra to know Levitra could run all the hardware at once, so to speak, distributing blood on an equal basis and letting us think and reason while still honoring Madame’s signature.

It’s worth noting that Levitra had a sponsorship deal with the NFL, perhaps the most macho organization in America. Levitra was the official wood medication for the National Football League. But that deal went away because the league felt Levitra’s approach to ads wasn’t so much about treating a condition as it was about performance enhancement. And any football fan worth his throwback jersey will tell you that the NFL is down on performance enhancers—be they steroids, speed or lead-in-the-pencil meds.

 

Side effects may include…

With some of the prescription drugs advertised, the side effects seem to clearly outweigh the very condition they seek to correct. For instance, let’s pretend you have a toenail that’s yellow, flaky and smells like the clearance cheese section at the Dollar Store. Additionally, said nail is jeopardizing your budding career as a sandal model.

So you sit down with your Health Care Professional and ask him or her about Lamisil, a drug made by Novartis to clear up nail fungus infections. While there’s no doubt your nail problem is a challenge, does it cause enough problems to make these side effects OK? (Side effects are courtesy of Novartis.) “The most commonly reported side effects were headache, which occurred in 12.9 percent of patients, gastrointestinal symptoms, including diarrhea (5.6 percent), upset stomach (4.3 percent), taste disturbances (2.8 percent), nausea (2.6 percent), abdominal pain (2.4 percent), flatulence (2.2 percent), rash (5.6 percent), itching (2.8 percent), hives (1.1 percent) and abnormalities in laboratory tests of liver enzymes (3.3 percent). In rare instances, serious side effects on the liver, including rare cases of death and liver transplant, have occurred in people taking Lamisil tablets. In the majority of these cases, the patients had preexisting medical problems that may have contributed to the event, and therefore the relationship between the event and Lamisil tablets was unknown. Because of the potential for liver damage, people with liver disease should not take Lamisil tablets.”

I don’t know about you, but if my choices are a bad nail versus hives, flatulence or death, I’m buying a new pair of shoes.

Another drug that forces consumers to weigh condition versus cure is Requip, a drug produced by GlaxoSmithKline to treat Restless Legs Syndrome. You may have the condition if you’re an adult and you have the compelling urge to move or disturbing sensations in your legs. Those are the symptoms, according to the company, though to me it sounds a lot like a Rolling Stones concert now that Mick and Keith have turned 75. The side effects? Nausea, drowsiness, vomiting, dizziness or feeling sweaty when you stand up. Still sounds like a Stones show.

Here’s where it gets interesting. Folks who take Requip may develop unusual impulses or behaviors such as pathological gambling or hypersexuality. Seriously, I can’t make this stuff up. (Well I could, but NorthBay biz has pretty strict rules about that kind of thing.)

Makes me think that if the doc gave you Requip and Levitra, you’d be all set for a week in Vegas. But that probably isn’t the marketing approach the companies have in mind.

Here’s the last word on side effects: Lunesta is one of the best-selling meds for sleep issues. One of the side effects listed with the drug is that it may cause drowsiness. Huh? Isn’t that what I want from a sleep medication?

One of the enduring controversies regarding direct to consumer advertising is how much the costs of the ads drive up the cost of drugs along with overall medical costs. In these days of managed care, it’s worth noting that the top 11 pharmaceutical companies in the world spent $100 billion in 2004 on advertising and marketing, and just $50 billion on research. Traditionally, drug companies have cited skyrocketing research costs as a reason drugs cost so much. Now it would appear the companies are spending far more on pen and pad giveaways for doctors as well as TV time.

What’s up, Doc?

Doctors are also troubled by how direct-to-consumer ads have changed how they interact with patients. “Physicians need to play their role of learned intermediary, but sometimes patients walk in after seeing an ad and feel like that drug is the only thing to do,” says Dr. Levine. “It’s good that patients come in wanting to participate more in their treatment, but not every drug advertised is going to be right for them—and I think sometimes they’re convinced by the ad that it is.”

Dr. Klay has also seen a change in how patients receive information after watching an ad. “Sometimes you get the feeling that if you don’t prescribe the drug, they’re going to keep looking for other doctors who will,” he says. “Another danger with the ads is that patients come in with this idea that the drug they saw is the only one for them, when it may have side effects that are a problem for them or there may be generic drugs or even over-the-counter drugs that work just as effectively.”

He brings up an interesting point. Drug companies are protected by patent laws for a certain period of time after creating a drug. When the drug comes off patent, any company in the marketplace is free to create the same drug—and sell it for far less. A practice that’s becoming all too common is for a drug company to take a best-selling drug, tweak the formula just a little, and register it just as the original drug comes off-patent. An example of the trend is Project Shark Fin, an undertaking by drug company AstraZeneca to keep the money rolling in as Prilosec’s patent sun was setting.

Over a five-year period prior to 2001, the heartburn drug brought in $26 billion in revenues. “Shark Fin” referred to what the drug’s profits and company revenues would look like if it couldn’t come up with a replacement for the drug. After looking at more than 50 ideas, the company decided to cut the formula for Prilosec and concentrate the new drug to treat one specific heartburn symptom. The new drug, called Nexium, was marketed heavily and cost $120 a month while Prilosec went off patent, morphed into Prilosec OTC (over the counter) and sold for $20. The drugs were not identical, but close enough so that patients on Nexium could have taken Prilosec OTC and received virtually the same benefit. And AstraZeneca ended up with another big-time winner while consumers, convinced that Nexium was the answer, begged doctors to prescribe it.

So drug companies have found a formula that generates a frightening amount of revenue by going straight to consumers and putting doctors on the spot. The direct-to-consumer approach has turned the traditional doctor/patient relationship on its head. “It’s forced doctors to be clear with patients up-front about uncertainty of the drugs and, in some cases, the dangers those drugs could cause depending on the patient;” says Dr. Levine.” And the level of expectation with patients also puts pressure on doctors to find a way to explain that other drugs or other forms of treatment might work better, which isn’t always what the patient wants to hear.”

Dr. Klay says the popularity of drugs that are advertised has put pressures on doctors’ schedules. “When someone comes in convinced that only a certain drug will work, the doctors have their work cut out for them. Or patients come in with ads they’ve taken off the Internet. Those patients can take doctors away from patients who have conditions that require more time or treatment.”

As troubling as direct-to-consumer drug advertising is for some doctors, Dr. Klay is worried about the next step. On TV shows like “Good Morning America” and “The View,” new ads are running not for drugs, but for a new surgical procedure for obesity that includes using bands to restrict the capacity of the stomach. “At what point does it end?” he wonders.

Author

  • Bill Meagher

    Bill Meagher is a contributing editor at NorthBay biz magazine. He is also a senior editor for The Deal, a Manhattan-based digital financial news outlet where he covers alternative investment, micro and smallcap equity finance, and the intersection of cannabis and institutional investment. He also does investigative reporting. He can be reached with news tips and legal threats at bmeagher@northbaybiz.com.

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