A billion reasons to worry that rushed FDA approvals put patient safety at risk

nuplazid-300x169Big Pharma has thrown a billion-dollar biscuit at the nation’s prescription drug watchdog, and with the admirable goal of possibly getting sick Americans faster pharmaceutical help, the federal Food and Drug Administration may be rushing risky, unsafe medications to market.

ProPublica, the Pulitzer Prize-winning investigative site, has posted a deep dig into the increasing warning signs that the FDA may be on a dangerous track with its plan to answer rightful criticisms that the agency for too long was too pokey in reviewing and approving prescription drugs for sale in the United States.

But the agency may be putting patients at grave risk with its plans to step on the gas, including allowing drug makers to pay for costs of reviews in exchange for ensuring they will be speedy. Big Pharma has forked over $905 million in 2017 — 75 percent of the agency budget for scientific reviews of branded and generic drugs — as compared with 27 percent funding in 1993.

The agency, in turn, has raced drugs down new paths to patients at a faster and faster pace, ProPublica reported:

The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency.

When drugs win quicker approval, Big Pharma profits soar accordingly — this, though the FDA and the public may not get full, accurate measures of medications’ safety and effectiveness for years after. As part of its speedy oversight scheme, the agency tells drug makers they must conduct post-market studies that show how patients fare with their pricey products. These are tougher to run and can take a decade to produce results. Meantime, patients not only may be paying for meds that are less effective than cheaper, already available drugs but their safety and lives may be put at risk.

ProPublica reporter Caroline Chen chronicles a growing number of cases in which FDA’s fast reviews look sketchier and sketchier, including the mounting record of thousands of adverse incidents, including hundreds of deaths, tied to Nuplazid, a $24,000-a-year drug for hallucinations and delusions associated with Parkinson’s disease.

To rush drugs’ reviews and approvals, FDA scientists too often are accepting new and dubious measures of medications’ usefulness, Chen reported. They, for example, might green-light a med that seems to show success in shrinking a tumor, rather than pushing for a more meaningful standard: does the drug extend patients’ lives?ProPublica also dug into information on what outside experts the agency is heeding as it reviews meds, finding a sizable Big Pharma footprint — hearings are stacked with scientists who take drug maker money or by representatives of patient advocacy groups who also rely on industry contributions.

With President Trump and FDA Commissioner Scott Gottlieb showing themselves to be committed disciples of the idea that speed may matter more than many other considerations in how they agency reviews and approves drugs, government scientists not only may be cowed but may be developing a culture of cozying up with Big Pharma, critics assert.

Michael Carome, director of the Health Research Group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official, told Chen: “Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”

This is not good. In my practice, I see not only the harms that patients suffer while seeking medical services but also the mayhem that can be inflicted on them by dangerous drugs. To be sure, the AIDS crisis exposed a dawdling, perhaps too-cautious FDA, which then was too slow to recognize a public health crisis and to muster appropriate resources to consider life changing and saving drugs that medical scientists urgently researched to respond to an epidemic. On the other hand, the thalidomide disgrace long should haunt the drug industry and regulators for waving ahead a drug that caused malformations in thousands of infants globally.

Moderation and common sense should apply at the FDA, which needs not just to appease Big Pharma, compromised patient advocacy groups, and others who advocate for rapid drug approvals. Speed kills, as the maxim holds. There’s a solid middle ground that worked for decades that appropriately moved drugs through reviews and approvals, neither too quickly nor too slowly. Patient safety should loom as large for regulators as industry profiteering.

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