miércoles, 1 de marzo de 2017
Críticas al meeting Pharma & President Trump (I): Drug approvals / David Lazarus*
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. (Más)
(*) David Lazarus is an American business and consumer columnist for the Los Angeles Times