Morton Mintz on the collapse of Congressional oversight
SHOWCASE | May 02, 2005
A personal account by the longtime investigative reporter and adviser to this Web site on his experience with Congressional oversight, how it should work, and how Congress and the press are falling terribly short. (The remarks were prepared by Mintz for a recent gathering of Washington, DC, area Nieman fellows.)
By Morton Mintz
The thalidomide story changed my life--changed it profoundly. It's the primary reason why I received a Nieman Fellowship. It's why I became a first-time author with a blurb from John Kenneth Galbraith on the dust jacket of the book I wrote while at Harvard. It's why I won my first journalism prizes. It's why I came to devote much of the last 40+ years to reporting on corporate crime and grave misconduct, particularly in the drug, tobacco, and automobile industries.
The effects on me were the least of it. For example, the story dealt a lasting blow to a notion, widely if foolishly held, that science and technology always or nearly always produce benign results.
The lead, from the Washington Post of Sunday, July 15, 1962, sums it up:
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 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 story—2400 words—at around 2 A.M. on Saturday, July 14th. Several hours later, my wife, Anita, and I and our three children left 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 Co., 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.
Sy Fishbein, an assistant city editor, had assigned me to interview Dr. Kelsey after a colleague, the late Bernard Nossiter, passed on a tip that she had kept thalidomide off the market. I learned subsequently that Sy picked me because he wanted an interviewer with a capacity for outrage; I had that, famously or infamously, along with zero expertise about the FDA or medicines.
The tip came from an aide to Estes Kefauver, who had 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 a manufacturer to provide the FDA with substantial scientific evidence — well-controlled clinical studies — showing that a medicine was not only safe, but also effective in its intended use. The 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.
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 legislation then went to the White House. President Kennedy did not invite Kefauver to the signing ceremony. He did invite Senate Minority Leader Everett Dirksen, who had led opposition to all of Kefauver's reforms.
But the system worked then, and for a long time thereafter.
"From the mid-1960s through much of the 1980s"—I’m quoting a 2002 article in The American Prospect—“Congress played an integral role in drug safety. Lawmakers"—principally the late Reps. L.H. Fountain and Ted Weiss, but also including Gaylord Nelson and Ted Kennedy in the Senate—“meticulously probed the regulatory histories of dubious drugs, uncovered FDA weaknesses and ordered corrections.”
The writer was Daniel Sigelman, who, as an investigator for Weiss, 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. Thanks to the Weiss subcommittee's digging, Lilly and Hoechst were criminally prosecuted. I was privileged to cover all or nearly all of those oversight hearings even if at the Fountain and Weiss hearings I was alone at the press table much of the time.
Decline of oversight began in the late ‘80s
Congressional oversight of the FDA and the drug industry began to decline in the late 1980s, while the Democrats still controlled the House. It spiraled sharply downward in 1992—still on the Democrats' watch—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." He denounced its then-Commissioner, David Kessler, who wanted to regulate tobacco, as "a thug" and "a bully."
The collapse of oversight had appalling consequences.
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. Consider the diet pills Pondimin and Redux. Taken in combination, they reliably caused heart-valve damage and sometimes a lung disorder that's fatal more than half the time. The resulting wrongful-conduct litigation was the largest ever against a pharmaceutical manufacturer. It was expected to cost what was then Wyeth-Ayerst Laboratories an astounding $13.2 billion, Sigelman wrote.
Just seven of the unsafe drugs caused more than one thousand deaths. How and why had FDA hurried them to the market? Why had withdrawals been slow? David Willman of the L.A. Times investigated. He found that the FDA had become a partner rather than a watchdog of the pharmaceutical industry. But unlike David, who in 2002 won a Pulitzer for a terrific series, 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 Energy and Commerce Committee, Billy Tauzin had FDA oversight jurisdiction but didn't exercise it. Over the course of 15 years, he took $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 is reportedly worth at least $2 million.
All of you know about Vioxx, which 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 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 July, he left the Hill to become President of the Biotechnology Industry organization.
Grassley to the rescue, but where is the press?
Early last year in the Senate, in startling contrast, Charles Grassley broke from the Republican pack. The chairman of the 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."
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 way. For a full decade, it has 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.
Maybe I've missed something, but I have yet to see a story in which Billy Tauzin, or Joe Barton, or House Speakers, or House and Senate majority leaders, were asked why, say, there'd 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 Terry Schiavo became their be-all and end-all. Or a story in which Mike Enzi was asked why his Senate Health committee hasn't done the FDA oversight that is being done by Charles Grassley's Finance Committee.
Let me end with a few questions:
If over the past dozen years Capitol Hill had properly overseen the FDA, and if the press had seriously and consistently reported on this nonfeasance, would the agency have rushed as it did to release, and not rushed to pull back, the 13 killer drugs, Vioxx, and the rest? Could there be a reasonable doubt that many thousands of Americans would not have been gravely or fatally harmed?
Even more importantly, were the lapses I've described symptomatic of a collapse of congressional oversight—and of press oversight of that oversight—in a host of other areas that bear heavily on national security and our lives, safety, health and pocketbooks?
I'm talking about everything from drug prices to military spending and National Missile Defense, from global warming to protections against another Al Qaeda attack, from the buildup to the invasion of Iraq to the treatment of prisoners and detainees.
We've got a problem.
Overseeing the overseers
- National Autism Association-Virginia Chapter
05/04/2005, 09:30 PM
I just read Mr Mintz' article on "The Collapse of Congressional Oversight" with keen interest. We are in the same fight again regarding mercury in vaccines. The people charged with oversight of the national childhood immunization program are too enmeshed with the industry and conflicted with their responsibilties to promote the program to attend to the safety of it. As usual, the press is busy covering Michael Jackson. Could someone wake them up? Please.