Tommy Denton

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Trust is a precious thing. If squandered, confidence once lost is so very hard to regain.

In this space Sunday, I considered the consequences of those "Luddites" who oppose virtually any technological innovation as a threat to the established, comfortable order. Much of the essay examined attitudes toward medical advances, particularly the recent controversy over the vaccination of young girls to prevent cervical cancer caused by the sexually transmitted human papillomavirus, which kills 4,000 women annually.

Attention turned to growing resistance around the nation after Texas Gov. Rick Perry issued an executive order requiring the vaccination of girls as young as 11 years old, raising questions about the safety of the vaccine, Gardasil, produced by pharmaceutical giant Merck and approved by the Food and Drug Administration in 2005 after clinical trials.

Last week, Gov. Tim Kaine indicated he will sign Virginia's version of the law requiring the vaccinations.

Revelations that doctors had hired on with Merck to testify before lawmakers and endorse Gardasil has further lowered public trust as skeptics challenge whether the testing of the vaccine had been sufficient to determine long-term, unintended consequences on patients' future health.

I noted in Sunday's column that such concerns may be intuitively prudent. Humanity, after all, has been capable of producing splendid discoveries that -- like space-based missile systems, nuclear power and electronic storage of personal medical and financial data -- can raise ethical as well as practical questions that ultimately could prove catastrophic if not accompanied by effective safeguards.

Arrayed against the relatively hasty rush to market -- Merck was competing with GlaxoSmithKline at the time of the FDA's approval of Gardasil -- were groups ranging from abstinence-only advocates, libertarian opponents of the "nanny state" and some voices in the medical community warning that the drug was being pushed too quickly to market and was too expensive.

Syndicated columnist Ellen Goodman wrote in these pages Friday that Merck certainly deserved no brief for its conduct in the lobbying and marketing initiative in its push to corner a lucrative market. Yet, Goodman said, "What has been lost in the debate about school-mandated vaccines is that this one is extraordinarily safe and effective against a lethal disease."

That conclusion would be more assuring had it not coincided with my discovery of an essay in The Boston Globe last week by Marcia Angell, noted senior lecturer in the Department of Social Medicine at Harvard Medical School. For several years, Angell was editor of the prestigious New England Journal of Medicine, and has written extensively on the vulnerabilities of the American health system to market excesses.

Angell's most recent critique issued a grim warning about just how much trust the public should place in the clinical trials to which Goodman referred as confirming the safety of new drugs.

In 1992, she wrote, "Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay 'user fees' to the FDA for each brand-name drug considered for approval. Nearly all the money generated by these fees has been earmarked to speed up the approval process.

"In effect," Angell continued, "the user fee act put the FDA on the payroll of the industry it regulates."

She indicated the agency fast-tracks approval of brand-name drugs, resulting in a backlog of some 800 trials for generics, which she noted "is worth billions of dollars to the drug companies whose high prices depend on not having generic competition."

As a result of the pressure from fees to speed up trials, Angell wrote, FDA trials approve drugs with less evidence than in the past. Some are even approved contingent on the companies' conducting further safety studies after the drugs are on the market -- an unfulfilled contingency, Angell noted, that the agency has ignored in 70 percent of about 1,200 such studies.

In addition, the FDA refuses to release unfavorable research results it possesses without the sponsoring company's permission. Talk about foxes in chicken coops.

Such congressionally approved purchases of the silence of the citizens' government invites the erosion of trust so essential to the democratic assumption of those risks worth taking for the public good. Public institutions should be on the public's side.

Denton's column appears in the Sunday and Tuesday editions of The Roanoke Times.