I’m the first to admire the strengths and virtues of the free-enterprise model as it applies to drug development and sales. This model encourages drug companies to employ talented people and to take risks in developing new drugs for serious medical problems. But let’s face it, current practices also produce undesirable effects.
1. When their drug that was wonderful last month is suddenly no good.
It’s been entertaining to watch the drug companies suddenly come up with new, patentable variations of their drugs just when their old patents are expiring. For example, since the 1970s, the Abbott company has been doing a dance with different formulations of valproic acid (used for seizures, migraines and bipolar disorder). At first, the brand name was Depakene, but when that patent ran out, Depakene was suddenly no good any more, and Depakote (just barely different enough to be patentable) was the only drug one should think of. Then when Depakote’s patent ran out, suddenly it wasn’t any good, either. Now Depakote ER (extended release) is the only way to fly.
This approach of reworking the old drug into longer-acting formats has worked for other drug companies, too. For example, GlaxoSmithKline has gone through the same dance with their formulations of bupropion for depression, evolving from Wellbutrin to Wellbutrin SR (sustained release) to Wellbutrin XL (extended release). Wyeth, seeing a good thing, followed the same path with venlafaxine antidepressant, going from Effexor to Effexor XR (extended release). It’s just an amazing coincidence how these new, suddenly-better drugs emerge just when the old drugs expire and face generic competition.
2. When they make us forget that the older drugs work just fine.
Since 1954 we’ve had effective anti-psychotic drugs to treat schizophrenia, but beginning in the 1990s a series of new anti-psychotics emerged, now called the “atypical” or “novel” anti-psychotics. Suddenly, the older drugs — all generic and therefore reasonably priced — were no good. Only the new, patented anti-psychotics were any good and one might even be guilty of malpractice if one prescribed an older drug (or continued prescribing one to a patient who seemed to be doing fine). Indeed, a generation of new psychiatrists cycled through training programs with this concept in mind, rarely writing a prescription for an older drug.
The alleged superiority of the newer drugs was tested in the recently completed CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) study and found to be absent. The study compared four newer drugs to an older drug, perphenazine, and the differences in outcome were minimal to none.
3. When they draw attention away from non-medication treatments.
Drug companies sell drugs. Therefore, when it comes to marketing their products, they have no interest in promoting — or even mentioning — non-drug treatments. There are no salespeople making the rounds of doctors’ offices to remind physicians of the rigorously proved benefits of stress management training for migraine and tension-type headaches, or of cognitive-behavioral counseling for depression.
4. When they hook us on samples.
Doctors’ offices receive samples of patented (high mark-up) drugs and not of unpatented (low mark-up) drugs. Therefore, patients are steered toward the expensive drugs by means of these “loss-leaders.”
5. When they shape medical practice.
Drug companies aggressively court the thought-leaders, like faculty members at medical schools, with financial perks such as impressive fees for speaking engagements. They also subsidize medical publications. The effects of these marketing activities on medical practice are not necessarily beneficial to patients.
For example, tissue plasminogen activator (tPA) is an expensive clot-dissolving drug approved for use in stroke patients. Its benefits are modest and its risks are real (brain hemorrhage and death). Thoughtful clinicians might reasonably conclude that the benefits of administering tPA do not outweigh the risks. But this is not the message that comes from many thought-leaders and publications. Instead, the implication is that administering this drug is a standard of care, and omitting it constitutes malpractice.
6. When the sales reps push unapproved uses.
Recently, a Pfizer sales rep told me that his company’s drug, pregabalin, is effective in preventing migraine. He shouldn’t have said that. Pregabalin is FDA-approved for treatment of epilepsy and nerve-pain, but not migraine. Although physicians in the U.S. are allowed to prescribe drugs for “off-label” uses, drug companies are prohibited from advertising their drugs for non-approved uses. In fact, Pfizer got in trouble for pushing another drug, gabapentin, for unapproved uses.
7. When doctors don’t think critically about what they’re doing.
This, strictly speaking, isn’t a deficiency of the drug companies. But because the only salespeople that doctors see are for expensive, branded drugs, the names of less expensive (or more effective) alternatives may not come to mind when prescriptions are written.