Column: Speedy drug approvals are risky, but drug companies have another idea that’s just terrible
At a recent meeting with pharmaceutical-industry bigwigs, President Trump declared that “we’re going to be cutting regulations at a level that nobody’s ever seen before.” He also said that “we’re going to have tremendous protection for the people.”
It’s hard to see how he can do both.
As with Trump’s proposed elimination of consumer safeguards, environmental-protection measures and financial reforms, the reality is that if his administration proceeds with a wholesale deregulation of the drug industry, the public will be largely undefended against the aggressive and potentially dangerous predations of multibillion-dollar conglomerates.
“We need regulations to make sure first and foremost that there’s drug safety and efficacy,” said Michael Santoro, a management professor at Santa Clara University and co-editor of the book “Ethics and the Pharmaceutical Industry.”
What Trump is basically proposing is less testing of drugs before they’re made available to patients.
“The pharmaceutical industry is a business and wants to bring drugs to the market quickly,” Santoro said. “That’s why you need the Food and Drug Administration to look at the medical and scientific evidence to make sure that speeding up the process doesn’t harm the public.”
In some cases, experts say, faster drug approvals may be warranted. It now can take years for a new drug to obtain the FDA’s go-ahead. For a terminally ill cancer patient, say, that can be a death sentence.
Sam Peltzman, a professor emeritus of economics at the University of Chicago, noted that the more testing that’s conducted, “the more stuff that can come to light that can prevent harm.” But he said “anything that speeds up the drug-approval process will have net positive effects.”
That remains to be seen. My colleague Melody Petersen reported on a $7,800-a-month cancer drug called Tarceva. Under pressure from Genentech and patient advocates, the FDA expanded use of the drug despite little evidence it worked. Patients suffered as a result.
The trick is finding the right balance of speed and safety, and it’s fair to wait and see what the Trump administration comes up with. He hasn’t yet even named an FDA commissioner, except to say that he has a “fantastic person” in mind.
Another change sought by drugmakers, however, is intended solely to boost profits. It would greatly expand the industry’s ability to pitch prescription meds directly to consumers.
This is a terrible idea.
The United States is one of only two countries — the other being New Zealand — that allows direct-to-consumer marketing of drugs. Every other nation has concluded that advertising powerful drugs for treating complex illnesses makes no sense when your target market isn’t qualified to fully understand the risks.
That’s not a knock on consumers. It’s an acknowledgement that doctors undergo at least three years of university pre-med courses, four years of medical school, and as much as eight years of residency and fellowship work.
All that education and training is for a reason. The practice of medicine isn’t for amateurs.
Yet the drug industry wants patients to think they’re entitled to have a hand in writing prescriptions.
“The idea is that consumers are central players in their health management and therefore have a right to be informed of different drugs,” said Lewis Grossman, a law professor at American University who specializes in food and drug law.
As such, the drug industry spent $5.2 billion in 2015 on direct-to-consumer marketing, up 60% from four years earlier, according to the healthcare news service Stat. That’s more than the estimated $4.9 billion spent for all Super Bowl commercials over the last 51 years.
Such crazy-high spending not only increases a drug’s retail cost but also boosts industry profit by steering people away from generics and other cheaper alternatives.
Many patients will insist on brand-name drugs they saw advertised on TV, and their doctors will write prescriptions rather than spend valuable time talking them out of it. For these reasons, the American Medical Assn. has called for a ban on direct-to-consumer drug advertising.
Yet the FDA is now considering a policy change that would expand direct-to-consumer drug marketing to so-called off-label uses — that is, for treatment of conditions that the drug wasn’t originally intended to remedy.
Even though doctors are permitted to write prescriptions for off-label drug uses, current rules state that a pharmaceutical company can’t pitch off-label uses to consumers without first backing up its claims with clinical trials.
If adopted, the new policy, which was unveiled at a public hearing the day after the November election, could allow drug companies to forgo much of that extra testing and leave patients to hope for the best.
“Drug companies have a very bad history of promoting products for which they haven’t been approved,” said Santa Clara University’s Santoro. “The industry hasn’t displayed trustworthiness as far as this goes.”
To be sure, there may be valid off-label uses for prescription drugs. I wrote recently about a young woman with an autoimmune disorder who was helped by a drug intended for heart troubles.
In that case, though, the decision to try an off-label drug was made by a cardiologist, not as a result of the woman seeing a TV ad.
Sarah Peddicord, an FDA spokeswoman, told me the agency wants a rule that “best protects and promotes the public health in view of ongoing developments in science and technology, medicine, healthcare delivery and constitutional law.”
If that’s the case, the agency should defer to the expertise of doctors, who are in the best position to understand the risks and rewards of off-label drug use.
A study last year by Canadian and U.S. researchers found that patients using off-label drugs without strong scientific evidence of effectiveness were 54% more likely to experience adverse side effects, such as an allergic reaction, or gastrointestinal or respiratory complications. Or worse.
That’s not an easy thing to communicate in a slick 30-second ad on prime-time TV. In fact, it has no business being addressed in such a slapdash manner.
Some deregulation of the drug industry may help patients. The Trump administration is on the right track if it can safely accelerate drug approvals, promote production and use of generics, and lower drug prices through increased competition.
It absolutely shouldn’t permit pharmaceutical companies to expand their direct-to-consumer marketing. The administration should heed the medical community’s call to end the practice and bring us in line with nearly every other country.
Diagnosis: It just isn’t healthy.