Magazine article Nieman Reports

What Happens When No One Is Watching? When Congress Relinquishes Its Oversight Role of the Food and Drug Administration, the Press Reduces Its Watchdog Role When It Comes to Drug Safety

Magazine article Nieman Reports

What Happens When No One Is Watching? When Congress Relinquishes Its Oversight Role of the Food and Drug Administration, the Press Reduces Its Watchdog Role When It Comes to Drug Safety

Article excerpt

Until nearly a half-century ago, reporting on unsafe and ineffective medicines--their manufacturers, their prescribers, their government regulator, their victims--was rare. In a chapter I wrote, "Drug Success = News; Drug Failure = NonNews," for a 1965 book, (1) documented a stenographic pattern of reporting about the drug industry not unlike what happened during the run-up to the Iraq War.

* In 1952, the publisher of a drug industry weekly, F-D-C Reports, usually referred to as "The Pink Sheet," was able to say that the industry had been enjoying a "sensationally favorable" press.

* In 1963, at a national symposium on communications and medical research, Arthur J. Snider, science editor of the Chicago Daily News, said: "My concern is that the record would show that 90 percent of the stories we have written about new drugs have gone down the drain as failures. We have either been deliberately led down the primrose path or have allowed ourselves through lack of sufficient information to be led down the primrose path."

* In 1964, in The Saturday Review, John Lear wrote: "It is encouraging to record the interest now expressed in drug marketing problems by such newspapers as The Wall Street Journal. But it may be asked where were the potent organs of the daily press when the drug makers were pulling political and economic strings to prevent the facts from being exposed. When The Saturday Review began reporting the worst abuses in drug marketing in 1959, only two newspapers were willing to assume responsibility for wider dissemination of [our magazine's] independently obtained information. One of those two was the St. Louis Post-Dispatch; the other was Advertising Age."

I couldn't know then that in a few years that pattern would start to break apart, in large measure because of a story I reported for The Washington Post. Even when I was handed this assignment by an assistant city editor, Sy Fishbein, I didn't have the faintest notion of its potential consequences. Nor did I understand at the time why he would assign it to a reporter who'd never written a word about prescription drugs, the pharmaceutical industry, or the Food and Drug Administration (FDA).

Turns out that after another Post reporter had passed on a tip that an FDA medical officer, Dr. Frances Kelsey, had fought hard within FDA to keep the baby-deforming sedative/tranquilizer thalidomide off the market, Fishbein wanted an interviewer with a capacity for outrage, which I had. The tip had come from an aide to Estes Kefauver, who'd been fighting a long, losing battle to drastically strengthen the Food, Drug, and Cosmetic Act of 1938. Building on findings in investigative hearings by his Senate antitrust subcommittee, he proposed amendments to require that a manufacturer provide the FDA with substantial scientific evidence--based on well-controlled clinical trials--which demonstrated both a medicine's safety and its effectiveness in its intended use. His amendments also proposed mechanisms to prevent the price gouging that was rampant even then.

Only a few weeks before my story ran, his Senate foes, mostly Republican friends of the pharmaceutical industry, gutted the amendments. They did this in a secret meeting he'd known nothing about.

My story was published in the Post on July 15, 1962. Here is the lede:

   This is the story of how the
   skepticism and stubbornness
   of a government physician prevented
   what could have been
   an appalling American tragedy,
   the birth of hundreds or indeed
   thousands of armless and legless
   children. The story of Dr.
   Frances Oldham Kelsey, a Food
   and Drug Administration medical
   officer, is not one of inspired
   prophesies nor of dramatic research
   breakthroughs. She saw
   her duty in sternly simple terms,
   and she carried it out, living the
   while with insinuations that she
   was a bureaucratic nitpicker,
   unreasonable--even, she said,
   stupid. … 
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