I recently had to submit a special request on behalf of a young man in my practice to authorize a prescription for Nexium (esomeprazole) for his heartburn. Medicaid had switched its preferred drug for stomach acid-related problems from Nexium, which costs at least $257 per month, to Protonix, which costs as low as $230.00 per month. And while Nexium has no generic, the generic for Protonix, pantoprazole, costs even less—$10.75 per month. Theoretically, Protonix and its generic should be just as effective as Nexium for the patient's complaint, but he insisted that it didn't work as well. Was it all in his head or was there really a difference?
Getting doctors and patients to choose inexpensive generics over costly brand-name drugs in the same therapeutic class—in this case stomach acid-blockers known as proton pump inhibitors—could save huge amounts of health care dollars, both for private insurers and the government. Nexium alone cost our health care system nearly $6 billion in 2013, despite having many lower cost therapeutic alternatives.
In most states, a pharmacist cannot substitute a lower cost generic unless it is exactly the same as the brand. But that is starting to change. Allowing a pharmacist to switch a prescription to a similar drug in the same class is called therapeutic substitution. One state, Washington, permits doctors to register for a voluntary program that allows therapeutic substitution by pharmacists. But the pharmaceutical industry and some patient advocacy groups oppose laws allowing therapeutic substitution.
The argument by opponents asserts that while drugs may be comparable in large populations, individual patients respond differently. If a patient is having a good response to one drug, he or she may not respond equally well when another drug in the same therapeutic class is substituted. Drugs should be changed only when they're not working, not just because a cheaper one becomes available, the argument goes.
This sounds very much like the arguments mounted against generic substitution 40 years ago. Patients—and many doctors—were convinced that generic drugs weren't as good as the brand-name drug. Extensive research demonstrates conclusively that this is almost never true. The active ingredient in generic drugs must be chemically identical to brand-name drugs. Generic drug companies must also prove that the way the drug is manufactured produces the same blood levels in the same amount of time as the brand-name drug. The resistance to generic substitution has largely, but not completely, subsided.
Part of the resistance to generic substitution can be explained by what is known as the placebo effect. When a patient is convinced that a pill is going to work, then there is a high likelihood that it will produce the desired effect even if the pill turns out to be just a sugar pill (placebo). Conversely, there is also a reverse placebo effect -- if the patient is skeptical about the drug's effectiveness, it is less likely to work and more likely to cause unpleasant side effects.
Is the placebo effect just a figment of the patient's imagination? No. Strong belief can result in observable physiological changes. "Mind over matter" is not just a quaint saying. The more confidence the prescriber has in the effectiveness of a drug, the more confidence the patient will have and the more likely a good result will be achieved. This has been known for millennia and is the basis not only for traditional medicine, but for faith healing and shamanism as well. Unfortunately, it has also been the basis for quackery and unscrupulous marketing of worthless home remedies.
So, I have no qualms about submitting the request to Medicaid to authorize Nexium for my patient. My goal and his is to alleviate his heartburn. Medicaid may spend a little more for his prescription, but 99 out of 100 other patients have switched from Nexium to Protonix with no problem. And since Protonix is available as a generic, the potential savings overall are actually very high.
What I do worry about, though, is the role that drug companies play in using the placebo effect to improve their bottom line. They do this primarily through the use of samples, manufacturer coupons and direct-to-consumer advertising. And to influence doctors, pharmaceutical sales representatives ply specialists with samples of the "latest and greatest"—and most expensive—drugs. I frequently see patients with heartburn who have been started on samples of Dexilant (dexlansoprazole), which is a minor chemical variant of lansoprazole (Prevacid). The two drugs work about the same, but Dexilant is 600 percent more expensive than generic lansoprazole, just like Nexium is over 200 percent more expensive than generic pantoprazole.
If a gastroenterologist is giving a patient a sample of Dexilant or Nexium, along with a message that this drug is better than others in its class, and the patient is also bombarded with glossy television advertisements reinforcing that message, it's no surprise that some patients will be convinced that a less-expensive therapeutic or generic alternative doesn't work as well.
The problem isn't that it's "all in the patient's head"; the problem is who's messing with the patient's head.
Stephen R. Smith, M.D., M.P.H., Community Catalyst physician consultant