Spring 2009

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.

By Morton Mintz

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 = Non-News,” for a 1965 book,1 I 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).

‘The story dealt a lasting blow to a notion, widely if foolishly held, that science and technology always or nearly always produce benign results,’ I reminded these journalists.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. What she did was refuse to be hurried into approving an application for marketing a new drug.

In a talk at a gathering of Washington, D.C. Nieman Fellows in 2005, I told them about the chain of events leading up to this assignment:

In September 1960, the U.S. licensee of the German investor and manufacturer of thalidomide—a sedative or tranquilizer, depending on dosage—applied for FDA approval to sell it in the United States. Not until April 1962 did it become widely known that in numerous other countries, the mothers of several thousand “thalidomide children” had taken the drug during the first trimester of pregnancy.

I interviewed Dr. Kelsey three months later. I finished the 2,400-word story at around 2 a.m. on Saturday, July 14th and, several hours later, my family set out by car for Cape Cod. My spies told me afterward that the managing editor thought the piece was too long, but the news editor had said, ‘I can get it in.’ He did.

Seventeen days later, a Senate subcommittee led by Hubert Humphrey held an FDA oversight hearing at which it came out that in a promotional stunt, the licensee, the William S. Merrell Company, had contrived to give away 2.5 million so-called ‘experimental’ thalidomide pills to physicians, causing 10 American infants to be born with seal-like flippers rather than arms and legs.

As I went on to say in that 2005 talk, “the story transformed Capitol Hill.” Suddenly, Congress became a tiger, rushing to toughen the drug law by passing what came to be called the Kefauver-Harris Amendments of 1962. It refused only to enact the proposals for competitive pricing, these being far more repugnant to the industry than efforts to assure safety and efficacy.

“The story dealt a lasting blow to a notion, widely if foolishly held, that science and technology always or nearly always produce benign results,” I reminded these journalists.

One reason for that “lasting blow” was that whistleblowers in the FDA began to come out of the woodwork. At last, they’d found a reporter for a major news organization who would pay attention to their intimate knowledge of agency leaders rushing to approve drugs despite inadequate evidence of safety and efficacy.

Reporting on the Pill

Another example of where watchdog reporting of the FDA was essential involved the emergence of birth control pills. I wrote about 40 stories for the Post about this topic, plus articles in The New Republic and Columbia Journalism Review, as well as a 1969 book, “The Pill: An Alarming Report.”

My first story for the newspaper, co-reported by the late Nate Haseltine and published in December 1962, was headlined, “Safety of Birth Control Pill Questioned.” As the story revealed, the case that its safety had been established was suspect—for good reason.

In May 1960, Dr. William H. Kessenich, director of the FDA’s Bureau of Medicine, had sent Commissioner George P. Larrick a document that would become the basis for the agency approving the pioneer pill later that year. It was this approval that would open the floodgates for oral contraceptives that would be taken by hundreds of millions of women worldwide. But how good was the underlying science?

“… the evidence establishes the safety … for use in conception control” of G.D. Searle & Company’s Enovid [the brand name of this birth control pill], Kessenich concluded. Yet in the same document he acknowledged that the “entire series of clinical cases”—the foundation of his and the FDA’s conclusion of “safety”—was one that a subsequent FDA commissioner, Dr. James L. Goddard, would tell a national TV audience was not enough.

Only 132 women had received Enovid continuously for a year or more. Half of them had taken the tablets for 12 to 21 consecutive menstrual cycles; the other half had taken them for 24 to a maximum of 38 consecutive cycles. The italicized words in the previous sentences are important operative words; brief or occasional ingestion of powerful chemicals insufficiently assures safety for a person who might take the pill for up to 29 years, the duration of the typical childbearing age span. I should emphasize here that the issue was not whether Enovid was safe but whether the evidence of safety warranted its release to the market.

At this time, Julius N. Cahn was the one-man staff of a Senate Government Operations Subcommittee led by Senator Hubert Humphrey. Cahn obtained the Kessenich document from FDA files, and the subcommittee published it early in 1963. Its publication received almost no attention in the press or, for that matter, in the medical community. But this document and other hasty, scientifically unwarranted FDA drug approvals, did arouse interest on Capitol Hill. “From the mid-1960’s through much of the 1980’s Congress played an integral role in drug safety,” wrote Daniel Sigelman in a 2002 article in The American Prospect. “Lawmakers meticulously probed the regulatory histories of dubious drugs, uncovered FDA weaknesses, and ordered corrections.”

Sigelman, counsel to the Congressional subcommittee, found that Eli Lilly, in the case of the anti-arthritis drug Oraflex, and Hoechst AG, in the case of the antidepressant Merital, had known of but failed to report many deaths of patients on these drugs. It was thanks to the digging of this subcommittee that Lilly and Hoechst were criminally prosecuted. And I was privileged to cover all or nearly all of those oversight hearings, even if at many of these hearings I was alone at the press table much of the time.

Congressional Oversight Slips Away

In the late 1980’s, Congressional oversight of the FDA and the drug industry began to decline at a time when the Democrats still controlled the House. By 1992, it spiraled sharply downward with passage of a highly dubious law allowing the industry to pay so-called user fees as a way to speed FDA approval of new drugs. Oversight collapsed utterly in January 1995, when the Republicans took control of the House, and drug and tobacco industry campaign contributions took control of them. Speaker Newt Gingrich called the FDA the “leading job killer in America” and denounced its then commissioner, David Kessler, who wanted to regulate tobacco, as “a thug” and “a bully.”

In my 2005 talk, I explained how the collapse of Congressional oversight had appalling consequences and described some excellent watchdog reporting, its lack of impact in some quarters, and a surprising resurgence of interest on Capitol Hill:

In the decade ending in the fall of 2002, 13 dangerous drugs were withdrawn from the market after causing many hundreds of deaths and many thousands of injuries. Just seven of the unsafe drugs caused more than 1,000 deaths.

How and why had FDA hurried them to the market? Why had withdrawals been slow? David Willman of the Los Angeles Times investigated. He found that the FDA had become a partner rather than a watchdog of the pharmaceutical industry. But unlike Willman, who in 2001 won a Pulitzer for his reporting, House leaders had no interest in investigating the FDA’s role in approving even one of the drugs that caused needless deaths and injuries or in determining what led up to $13 billion in legal claims and costs. Least of all did they want to investigate why and how the FDA had become a partner of an industry that has more lobbyists than Congress has members, that was filling the campaign coffers of friendly lawmakers to overflowing, and that held out the prospect of high-paying jobs for overseers who wouldn’t oversee.

As chairman of the House Committee on Energy and Commerce, Billy Tauzin had FDA oversight jurisdiction but didn’t exercise it. During 15 years, he took in campaign contributions totaling more than $218,000 from the drug industry. In January 2005, the Louisiana Republican became president of the Pharmaceutical Research and Manufacturers of America. His annual pay package was reportedly worth at least two million dollars.

Vioxx—a drug approved by the FDA—has caused an estimated 88,000 to 139,000 heart attacks and strokes. But it and related painkillers such as Bextra and Celebrex were not a problem for Tauzin. Nor for his successor, Joe Barton. The FDA, Barton has declared, should make no more rulings on the effectiveness of drugs; rather, it should confine itself to measuring whether they are “safe, pure and packaged safely.”

James C. Greenwood of Pennsylvania served under Tauzin as chairman of the Subcommittee on Oversight and Investigation. Thus he too had jurisdiction over the FDA. Of his 2003-04 donors, The Washington Post reported, 10 identified themselves as drug company presidents; six are vice presidents, and another six are executives. In January 2005, he left the Hill to become president of the Biotechnology Industry Organization.

Early last year [2004] in startling contrast, Charles Grassley broke from the Republican pack. The chairman of the Senate Finance Committee undertook tough oversight of the FDA, notably including its handling of childhood antidepressants and Vioxx and related painkillers. Moreover, Grassley served notice that he’d protect the FDA’s internal whistleblowers, such as medical officer David Graham, who had called Vioxx a “profound regulatory failure” by an agency “incapable of protecting America against another Vioxx.”

Where Is the Watchdog Press?

I believed then—and still do—that it’s all very well to criticize the FDA and the likes of Gingrich, Tauzin, Barton and Greenwood. But does the press deserve a pass? No, it does not. For a full decade, it failed to inform the public of the prolonged, corrupt pre-Grassley abdication of Congressional oversight of the agency responsible for the safety of their medicines and of its causes, consequences and implications. Failed, that is, to connect the dots.

Perhaps I missed some reporting that shed light on this, but in that time I didn’t see a story in which Tauzin or Barton or any House Speaker or Senate majority leader, was asked why there had not been an oversight investigation of the seven drugs that caused the deaths of a thousand Americans. Or a story on why these deaths seemed to matter not at all to them, while the death of a comatose woman, Terry Schiavo, was made so prominent. And where was a story in which Senator Mike Enzi was asked why the health committee he chaired hadn’t done the kind of FDA oversight that the finance committee undertook when Grassley was its chair?

Congressional oversight is a core constitutional function—indispensable to the proper workings of a democracy. During the years of its absence from Capitol Hill, I tried repeatedly to persuade The Washington Post to report on the collapse of Congress’s oversight and its consequences, not only of the FDA, but also of the executive branch more broadly.

In 2005, my final attempt ended with a national desk editor telling me, disdainfully, face-to-face, “Oh, Mort, I get those story ideas all the time.”

Morton Mintz, a 1964 Nieman Fellow, is a senior advisor and frequent contributor to the Nieman Foundation’s Watchdog Project. During his 30 years as a reporter at The Washington Post, he broke the thalidomide story in 1962 and then went on to report extensively on unsafe and ineffective medicines and medical devices, including the disastrous Dalkon Shield IUD.


2 Comments on What Happens When No One Is Watching?
susan vaughan says:
November 4, 2009 at 2:16pm
and now Pharmacia is bypassing FDA, ignoring its label recommendation on Halcion/triazolam, somehow, by getting DOCS and ADA to allow/promote the drug's use off-label AND IN HIGH DOSES, as a dental sedative. the whole horrible history of the drug and excessive ADE's reported to the FDA concerning severe and bizarre, even dangerous psychological effect is being conveniently swept under the rug through use of a slick marketing campaign that would make Goebbels blush. -- "just take two little pills and you'll sleep through your appointment and awake refreshed, probably not even remembering anything about it." --something to that effect. If you develop severe insomnia, anorexia, then delusions, and go see a doctor, they won't ask what your dentist gave you, and you will be too distressed and confused to even think of it or remember (Halcion's known for its amnesiatic effects). So the doc will give you trazadone or something to help you sleep - and that something can exacerbate your existing symptoms and make you psychotic, even paranoid, even hallucinatory or violent/suicidal. When you totally flip out and are put in a mental institution against your will, you'll be in no shape to remember the dental drug and the mental hospital won't make that connection either. And you're never heard from again. So the dental community and esp. DOCS's founder who's making money training dentists to overdose patients with Halcion, will say there are no adverse effects, because neither you nor anyone else will make the connection, or be able to prove it. YET. But I'm working on it. My daughter is the victim, and I won't stop until someone takes responsibility.
Glenn Cahn says:
May 31, 2009 at 3:30am
It's great to see that there are still some journalists who have high standards, for reporting the truth, and for holding a fire to Congress in an attempt to get them to do what they are supposed to: government of the people...for the people.


Submit a Comment
   
   
   
Enter the words above: * Enter the numbers you hear: *
Switch to audio Switch to image
Thank you for your comment. It will be published after it is approved by an editor. Read our comments policy »