Time may be coming soon when medications are individualized

 

No matter what your politics, a conservative approach to medications is a good idea.

The old, jokey line was "take two aspirins and call me in the morning." But, of course, doctors prescribe a lot more than just aspirin these days. The medicine cabinet is crammed full: cholesterol-lowering statins, stomach acid-reducing proton-pump inhibitors, antidepressants, asthma drugs, diabetes drugs, sleeping pills, hormones. The amount of money Americans spent on prescription drugs tripled between 1997 and 2007, although growth in our collective "pill bill" has slowed for many reasons.

People who genuinely need medications should take them; indeed, getting people to take medications as prescribed is a persistent problem. But there's some questioning of prescribing practices these days, much of it inspired by a growing conviction that American health care has become too dependent on expensive medications.

Dr. Gordon D. Schiff, a researcher at the Center for Patient Safety Research and Practice at Harvard-affiliated Brigham and Women's Hospital (Boston, Massachusetts), wrote an article about more judicious use of medications published earlier this year in The Journal of the American Medical Association.

The article grew out of an educational project funded by a settlement of a lawsuit against the maker of gabapentin (Neurontin) alleging that the drug had been promoted illegally. Dr. Schiff and his coauthor, Dr. William Galanter at the University of Illinois-Chicago, identified a half-dozen broad principles of what they call "conservative prescribing." We've listed them below, revised so they take into account more of the patient's point of view. We also spoke with Schiff to get a few more specifics.

Some of the items may seem a little obvious -- did anyone ever say that side effects shouldn't be a concern? But saying and doing often diverge. Besides, the hope here is that by laying out a few principles, in contrast to a long list of dos and don'ts, a better balance between the risks and benefits (and costs) of taking drugs might be found.

1. CONSIDER ALTERNATIVES TO MEDICATION

It's understandable that people want to leave the doctor's office with a prescription. A prescription sends the message that the doctor believes you've got a real illness -- and, better yet, that there's something that can be done about it. But playing to this psychology can mean that non-drug alternatives get short shrift.

Improving your diet, becoming more physically active, getting enough sleep, using stress-reduction techniques -- these take more time and effort. But study after study has shown that they can have a powerful effect -- often more powerful than any medicine -- on a whole range of health problems.

Perhaps the trick is to view the non-drug alternatives as being just as "medical" as any pill you might take. Examples mentioned by Dr. Schiff include properly attending to your sleep "hygiene" (avoiding evening caffeine or long daytime napping) instead of getting a prescription for sleeping pills and using orthotics (shoe inserts that alter the alignment of your foot and leg) instead of taking pain relievers for foot pain.

(We published an article in 2008 about alternatives to medications. We've made a full-text version available on our Web site at www.health.harvard.edu/healthextra.)

2. TAKE IT STEP-BY-STEP. DEPEND ON THE EVIDENCE.

Doctors and patients can be a little scattershot in their use of medications. There's a lot of switching from one drug to another. Or people start taking several drugs all at the same time.

A more cautious, step-by-step approach can help you -- and your doctor -- figure out what's working, what's not, and whether certain medications might be causing undue side effects.

Dr. Schiff also has a somewhat contrarian view of individualizing therapy, which ordinarily is seen as something to strive for. In his opinion, individualizing therapy can sometimes (not always, by any means) amount to a blank check to try all sorts of treatments that stand very little chance of working based on the evidence from clinical trials.

The time may be coming soon when medications -- and treatments of all types -- will be exquisitely individualized, calibrated to each person's individual genetic makeup. But for most conditions and medications we aren't there yet, and until we are, the clinical trial result remains the best guide to treatment.

After going up and up, American spending on prescription drugs has leveled off in recent years. It's still growing, but at a slower rate. In fact, in 2007, the amount spent on prescription drugs increased by just 1.6 percent, the smallest increase in over 30 years, according to an article published in Health Affairs in 2009.

The spending spree is abating for several reinforcing reasons, explained the article. The number of blockbuster drugs -- those with annual sales of over $1 billion -- started to boom in the late 1990s. In 1997, there were just six blockbusters. Nine years later, there were 52. But several blockbuster drugs have lost patent protection. That change has opened the door to competition from less expensive generic versions of the same medication, or from slightly different medications that are in the same class. And generic sales have taken off because health insurers have passed along the price difference to their customers in the form of lower copayments: Getting the generic pills means an out-of-pocket expense of $5 or $10, whereas buying the brand-name ones requires laying out, say, $20 to $30.

This trend is likely to continue as the patents for several big-name drugs expire. Losartan (Cozaar), the blood pressure medication, is scheduled to lose protection in 2010; atorvastatin (Lipitor), the cholesterol-lowering statin and the biggest blockbuster of them all, in 2011; and sildenafil (Viagra), the erectile dysfunction drug, in 2012.

It's too soon, though, to declare victory. Even when a drug loses patent protection, there may not be enough competition from generic manufacturers to drive down prices significantly. And, as discussed in the Health Affairs piece, spending patterns are shifting away from primary care drugs to specialty ones. Cancer drugs, in particular, are fantastically expensive.

For example, a single course of bevacizumab (Avastin), a new drug for advanced breast, colon, and lung cancer, can cost over $40,000. And vaccines, once touted as public health's great bargain, are now being marketed much like pharmaceuticals. Prevnar, a pneumococcal vaccine, and Gardasil, the anti-human papillomavirus vaccine that's designed to prevent cervical cancer, are now members of the blockbuster club.

3. KEEP A LOOKOUT FOR SIDE EFFECTS

There's no such thing as drug side effects, quips Dr. Schiff, only effects -- the ones we want and the ones we don't. The unwanted effects -- otherwise known as side effects -- may be mild or affect just a handful of people.

Even so, you should be clear about what they are and watch for them, especially when you first start taking a medication. And side effects should be a prime topic of conversation with your doctor.

You should also talk to your doctor about withdrawal symptoms if you stop taking a drug. People often mistake the symptoms of drug withdrawal for the symptoms of the condition being treated, which can create a vicious cycle of taking a medication just to avoid the withdrawal symptoms. A common example is the headaches people get when they stop taking pain relievers, especially if the pain relievers included some caffeine.

4. REMEMBER THAT NEW ISN'T NECESSARILY BETTER

Sometimes new medications are a real advance. They're more effective, have fewer side effects, or -- best of all -- both. But sometimes we are just responding to an ad campaign, equating new with improved when it isn't necessarily so. And new drugs, by definition, don't have much of a track record to go on, so it is often better to start first with the tried-and-true older ones.

Clinical trials are the best way we have to test medications and other interventions, but a trial involving just a few hundred, or even a few thousand, people taking a drug for a relatively short time can tell us only so much. It may take years and many more patients before the full side-effect profile of a drug is known.

Similarly, the full picture of a drug's longer-term outcomes -- how it affects health events like heart attacks, strokes, even death -- may be slow to emerge, in contrast to so-called surrogate markers, like cholesterol counts and blood sugar levels, which may point to health benefits but are, in the final analysis, convenient lab values.

5. WORK WITH THE DOCTOR

The doctor-patient prescribing relationship used to be straightforward and top-down: the doctor knew best, and the patient got a prescription.

But for a host of reasons, that paternalistic approach has been rejected.

Now, ideally, in many circumstances, the doctor's role is to present choices, explain the pros and cons, but let the patient -- within limits -- make the decision.

But the doctor-patient relationship is -- and always will be -- a difficult one to get right.

Some of us try to manipulate doctors into prescribing a certain treatment. Some of us want to be good patients, so if we're not taking a pill as prescribed, we may not fully own up to our nonadherence.

We take medications out of inertia, whereas if we were to talk it over with our doctors we'd find out that we were taking pills that aren't needed any longer and possibly doing more harm than good.

Of course, the burden shouldn't be all -- or even mainly -- on patients.

Doctors should take the time to raise these issues. And they need to be more open and encouraging of patients who want to try nonpharmaceutical approaches to health problems.

Time is a factor in all this.

Many physicians are under pressure to fit in as many appointments per day as possible, and if they are working against the clock, then it's harder for them to be working with the patients. The shortage of primary care physicians in many places doesn't help matters.

6. TAKING RESPONSIBILITY

Some medications start out like gangbusters, but their effectiveness seems to fade over the long haul. Others may take a while to kick in.

Either way, sticking with the prescribed dose for the prescribed period is important, especially when the prescription is for antibiotics.

Increasingly, good prescribing practices are going to hinge on the adoption of the electronic health record that will check for allergies, interactions, correct dosing, and so on. As hospitals and other groups introduce Web sites that allow people to see their personal health records online, more of us will experience the computerization of the medical record firsthand.

The hope is that patient access to this information will add another layer of protection against bad prescribing practices and get us all more involved in taking responsibility for our health care.

Harvard Health Letter

 

 

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