When Lipitor, the cholesterol-lowering pill, went off patent last month, it was supposed to be a turning point in the era of the blockbuster drug, and in many respects, it was. In its heyday, Lipitor was worth nearly $13 billion annually worldwide and losing a drug’s patent usually leads to a huge decline in sales as cheaper generic versions become available. As if in preparation for this day, the National Physicians Alliance launched its Top 5 project earlier this year, a list of things doctors should not do, one of which is prescribe a brand name cholesterol drug, or statin, rather than the generic. But Pfizer had also prepared for the end of Lipitor’s patent by cutting deals with pharmacy benefit managers to sell Lipitor just below the price of the first generic in an effort to dissuade other generic statin manufacturers from entering the market. Pfizer is also telling patients that it will sell Lipitor directly to them on the Internet.
Everyone knows that the blockbuster brand-name drug — developed and marketed at great expense by pharmaceutical giants who get a monopoly on the molecule for 20 years according to U.S. patent law — helps increase the cost of health care. In the next few months, other blockbusters such as the pain drug Celebrex, Seroquel for depression, Nexium for digestive problems, and Viagra for, well you know, will also be going off patent, and generic versions will be coming to pharmacy shelves near you.
That’s bad news for drug makers, which don’t have many big sellers waiting in the wings. But it’s good for patients, and not just because generics are on average more than 80% cheaper. It’s also good because many, maybe even most, of the blockbusters were hugely oversold to consumers and overprescribed by their doctors, and the loss of those big money makers could force the drug industry to take a hard look at its marketing strategies.
Take Lipitor, which was originally developed for patients with heart disease, specifically, people who had already had a heart attack or stroke and were at high risk of another. For this group of patients, reducing cholesterol with a statin cut their chances (by a little) of suffering a second heart attack, stroke and death. But that relatively small group of people is not who made Lipitor the greatest selling drug of all time. In order to sell to more people (lots more), Pfizer had to persuade doctors and the public that anybody with a beating heart and even mildly elevated cholesterol needed to be on a statin. At one point Pfizer even ran a magazine ad for Lipitor by showing the tagged toe of a corpse, above a headline urging women in their 50s to get their cholesterol checked. The reality? Hardly anybody who is merely at risk because of elevated cholesterol, but doesn’t actually have heart disease, will benefit from taking a statin. The same kind of hype was used to sell Celebrex, which is no better than good old Ibuprofen for most people, Seroquel, which is a potentially dangerous drug originally developed to treat schizophrenia, and Nexium, which is effectively the same chemical as generic Prilosec.
So even while Pfizer is now attempting to hold on to its market share by cutting deals with pharmacy benefits managers and directly targeting patients, there are several possible solutions to the blockbuster problem, some of which will happen all on their own. Genomics research will clarify who can really benefit from which drugs and who won’t be helped at all and will make it harder and harder to sell a pill to everyone. Through efforts like the National Physicians Alliance’s Top 5 project, doctors will become even more aware of marketing tactics and will be motivated to stop doing things that don’t benefit patients. Some experts have suggested changing patent law to give drug companies a set amount, say 15 years, of market exclusivity starting from the time they bring the drug to market. (Under current patent law, the clock starts ticking when the patent on the molecule is filed but development might take longer.) This might discourage the legal maneuvering they now engage in (tinkering slightly with the formula, etc.) to delay the moment when generics come in. I think it would be more effective to outlaw, or at least curtail, direct-to-consumer drug advertising, which has contributed mightily to the industry’s success in selling sometimes inappropriate drugs to patients.
In the meantime, remember the tag line at the end of every drug ad — “Ask your doctor” — but instead of asking for a drug, ask your doctor about it. Will this work for me? Has it been tested in a general population or only on selected patients who aren’t anything like me? What are the side effects? Looking for medical advice from doctors — instead of from commercials during a football game — can be a huge step toward taking fewer drugs, spending less on medical care and really focusing on interventions that work for us as individuals.