FDA and GE: Extra Radiation? Who Cares?

Controversy generated by recent reporting by Eric Lichtblau and Scott Shane of the New York Times about Food and Drug Administration spying on its doctors and scientists focuses on the blatant invasions of privacy, with Sen. Charles Grassley, R- Iowa, complaining of “Gestapo” tactics. But what about us?

What about the thousands of patients exposed to unnecessarily dangerous levels of radiation during mammogram screening and colonoscopies by General Electric medical imaging devices.

Frances Kelsey, whose work for the Food and Drug Administration blocked U.S. approval of the dangerous drug, Thalidomide.

As I prepare for my umpteenth (and hopefully last) scheduled scan over the past five years to check if that grapefruit-sized lymphoma tumor has left my pelvic area for good, I am relieved to remember that most of the scanning devices have had a Siemens, not a GE label.

As the Times reported, the F.D.A. spying focused on doctors who believed the agency gave shortshrift to concerns about excessive radiation coming from medical imaging devices. Lichtblau and Shane wrote:

“The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

“A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed ‘a substantial and specific danger to public safety.'”

During the first few decades of my life, there were no such scan scams to worry about. The influence of the pharmaceutical corporations, however, was already huge — and dangerous. Often, it took courageous whistleblowers — people of integrity unwilling to betray the public trust — to prevent disaster.

Thalidomide

It has been more than 50 years since my first extended visit to Europe as a university student. Most readers will be too young to remember, but a “wonder-drug,” Thalidomide, had just come on the market. This drug gave temporary rest and relief to millions, especially prospective mothers with morning sickness and problems sleeping. It was very popular in Germany.

Stationed in Germany more than a decade later, I witnessed the human results of the horrible side effects of Thalidomide, which had become available all over Europe, and beyond. Over 10,000 babies in 46 countries were born without limbs or otherwise disfigured and disabled. Those still alive would be in their late forties/early fifties now.

How did the United States escape this plague? One whistleblower, a woman named Frances Kelsey of the U.S. Food and Drug Administration saw through the charade of the drug company swindlers and stood up to it.

Although Dr. Kelsey came under extreme pressure to fall in step and approve Thalidomide, she scorned the testing that had been done by the Thalidomide manufacturer and blocked introduction of the drug into America.

For her unusual courage and integrity, President John Kennedy gave her the President’s Award for Distinguished Federal Civilian Serivce in 1962, after it became clear that she had singlehandedly prevented a public health disaster from befalling us in the United States.

Dr. Kelsey will be 98 on July 24; her courage should be celebrated — particularly in the light of the behavior of our present-day F.D.A. The F.D.A.’s current commissioner, Dr. Margaret Hamburg, should be put on the griddle — and sooner rather than later.

As the Sixties and Seventies wore on, the horrible damage caused by the drug made itself known. And what also became clear was the reality that a decade of American babies born whole, with all their limbs, owed a debt of gratitude to Frances Kelsey, whistleblower par excellence!

A close friend of mine, Tom Clark, tells me that he is of that generation. Tom added that his mother suffered miserably from morning sickness in bearing him. He is gratefully aware that he might well be missing a limb or two today, had his mother been able to acquire Thalidomide in the United States.

What happens to the likes of Dr. Kelsey at the F.D.A. today? Sadly, modern-day whistleblowers – whether in government, industry or even the press – more often than not face severe career reprisals, legal action and sometimes imprisonment, like Pvt. Bradley Manning jailed for allegedly leaking classified government documents to WikiLeaks. Rarely do truth-tellers get presidential awards.

Which reminds me of an open letter that ten other veterans of government service and I signed nearly eight years ago, on Sept. 9, 2004. Our “Truth-Telling Coalition” directed an appeal to “Current Government Officials.” We wrote:

It is time for unauthorized truth telling.

Citizens cannot make informed choices if they do not have the facts — for example, the facts that have been wrongly concealed about the ongoing war in Iraq: the real reasons behind it, the prospective costs in blood and treasure, and the setback it has dealt to efforts to stem terrorism. Administration deception and cover-up on these vital matters has so far been all too successful in misleading the public.

Many Americans are too young to remember Vietnam. Then, as now, senior government officials did not tell the American people the truth. Now, as then, insiders who know better have kept their silence, as the country was misled into the most serious foreign policy disaster since Vietnam.

Some of you have documentation of wrongly concealed facts and analyses that — if brought to light — would impact heavily on public debate regarding crucial matters of national security, both foreign and domestic. We urge you to provide that information now, both to Congress and, through the media, to the public.

Thanks to our First Amendment, there is in America no broad Officials Secrets Act, nor even a statutory basis for the classification system. Only very rarely would it be appropriate to reveal information of the three types whose disclosure has been expressly criminalized by Congress: communications intelligence, nuclear data, and the identity of U.S. intelligence operatives. However, this administration has stretched existing criminal laws to cover other disclosures in ways never contemplated by Congress.

There is a growing network of support for whistleblowers. In particular, for anyone who wishes to know the legal implications of disclosures they may be contemplating, the ACLU stands ready to provide pro bono legal counsel, with lawyer-client privilege. The Project on Government Oversight (POGO) will offer advice on whistle blowing, dissemination and relations with the media.

Needless to say, any unauthorized disclosure that exposes your superiors to embarrassment entails personal risk. Should you be identified as the source, the price could be considerable, including loss of career and possibly even prosecution. Some of us know from experience how difficult it is to countenance such costs. But continued silence brings an even more terrible cost, as our leaders persist in a disastrous course and young Americans come home in coffins or with missing limbs.

This is precisely what happened at this comparable stage in the Vietnam War. Some of us live with profound regret that we did not at that point expose the administration’s dishonesty and perhaps prevent the needless slaughter of 50,000 more American troops and some 2 to 3 million Vietnamese over the next ten years.

We know how misplaced loyalty to bosses, agencies, and careers can obscure the higher allegiance all government officials owe the Constitution, the sovereign public, and the young men and women put in harm’s way. We urge you to act on those higher loyalties.

A hundred forty thousand young Americans are risking their lives every day in Iraq for dubious purpose. Our country has urgent need of comparable moral courage from its public officials. Truth telling is a patriotic and effective way to serve the nation. The time for speaking out is now.