HEALTH CARE/Joan Retsinas

Fast Track to Disaster

The tortoise versus the hare: In Aesop’s parable, the tortoise won the race.

Today we root for the hare. “Fast Track” is the mantra of our technological age. Sitting at laptops, we get data, order goods, register our opinions, all in a nanosecond.

And we want medications in our hands as soon as the guardian-of-safety (a.k.a. Food and Drug Administration) gives them a green light.

But the FDA can be so slow, so bureaucratic, so nit-picking, while we, the desperate patients, wait.

A recent New York Times (Aug. 8) issue ironically pitted two hare-versus-tortoise stories. The “hare” tale recounts a judicial decision that will speed up the distribution of drugs (“Judge Cites Free Speech in Drug Case,” by Andrew Pollack). Briefly, the FDA blesses drugs for “approved” uses, though physicians often discover that a drug that works for one diagnosis will work for another. And word of the drug’s “potential” efficacy spreads. So physicians can and do prescribe that drug for an “unapproved” use.

The FDA, though, bars manufacturers from advertising the drug’s “potential” usefulness for those “off-label” uses. I use the word “potential” because the drug has not gone through vigorous testing for that use. Anecdotes and drug-company data do not constitute the evidence the FDA wants.

One company, Amarin, challenged that ban in Manhattan district court. The company argued that it should be allowed to tout the benefits of Vascepa, now approved to treat high levels of trigylcerides in the blood, as treatment for lower levels. So long as the marketing is “truthful” and “not misleading,” the court gave Amarin a green light to tout. “Free speech” trumps scientific caution. Not surprisingly, a coalition of drug companies cheers the ruling, seeing it as an opening to tout ad nauseam. And, again not surprisingly, the FDA and groups of scientists are talking “appeal.”

This hare-tale, allowing easier, quicker distribution of a drug, follows in the wake of a general enthusiasm for “fast-tracking” drugs, sometimes spurred by celebrities who wax enthusiastic on social media. Consider Kim Kardashian. On Instagram, she claimed that Diclegis cured her morning sickness. She added that it was safe, risk-free for baby and mom. The FDA responded, warning that evidence did not back up Ms. Kardashian’s enthusiasm. There are risks to Diclegis. But, regardless of the FDA warning, women everywhere, thanks to social media, were talking about Diclegis.

Yet the same issue of the Times offers a “tortoise” accolade. In an obituary for Frances Kelsey, the federal scientist who blocked the distribution of a much-ballyhooed Kevadon (a.k.a. thalidomide), the Times recounts the determination of a federal official to move slowly, despite pressure to move quickly. More than 50 years ago Kevadon, developed in Germany, had spurred raves from patients throughout Europe. This wonderful sedative gave patients normal sleep, with no hangovers. Better yet – Kevadon seemed to treat nausea, the bane of pregnant women. American physicians had started to distribute it for “investigational” uses. The manufacturer, Merrill, had stockpiled enough to send revenues soaring. The company needed only a green light from the federal government.

Dr. Kelsey didn’t give that green light. Even though thalidomide was legal in Europe, was prescribed for pregnant women, and was touted as safe, Dr. Kelsey doubted the touting: she wanted more data, more time, more analysis. In spite of tremendous pressure from physicians eager to help nauseous patients, as well as from a company eager to make millions of dollars, Frances Kelsey balked. She emerged as obstructionist, bureaucratic, slow.

Of course, history proved the wisdom of her slow-track approach: children in Europe were being born with shortened, or no, limbs – attributed to thalidomide. Today she is a heroine.

Yet she is an anachronistic heroine. In an age of instant gratification, we don’t like to hear “wait,” “not yet,” much less “no.” For terminally ill patients, 12 states have passed “right-to-try” laws, letting patients try experimental drugs, before FDA approval. We want whatever we think might help.

And we try to overrule – if not castigate - bureaucrats like Frances Kelsey for holding firm.

Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email

From The Progressive Populist, October 1, 2015

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