Watching the watchdog

WASHINGTON -- Senator Charles E. Grassley looks and sounds like the traditional grandfather he is, but the plain-spoken Iowa Republican is also the driving force behind a congressional charge to change the Food and Drug Administration.

In recent years, Grassley, 73, has relentlessly focused attention on the FDA, which has been racked by a series of high-profile problems. It allowed an antibiotic to be sold despite knowing that the drug's development was marred by fraud. It silenced FDA reviewer David Graham's finding that Vioxx users had higher rates of heart problems -- until the day Merck & Co. pulled the painkiller from the market. And a high-ranking FDA official approved a medical device that nearly two dozen staffers had rejected as ineffective.

Armed with insider information from whistle-blowers, Grassley says he is trying to prod the agency to change a culture that stifles and punishes dissenters. He has exposed internal FDA memos, e-mails, and conversations to unprecedented public scrutiny. Sunlight, he is fond of saying, ``is the best disinfectant."

Wyoming Republican Senator Michael Enzi, whose committee is supposed to take the lead on FDA oversight, says he is not threatened by Grassley's flurry of letters, press conferences, and congressional hearings.

``I don't care who looks into what, it's fine," said Enzi, chairman of the Senate Health, Education, Labor, and Pensions Committee.

Grassley said the FDA watchdog role is natural for him as Senate Finance chairman with oversight over Medicare , a program that spends heavily on prescription drugs. ``I've got absolutely every reason in the world to make sure that the Medicare tax dollar buys a safe and effective drug," he said.

The fifth-term senator rarely pulls the curtain of anonymity with an off-the-record reply. His ready answers can be as short and precise as his graying hair. And if his memory is occasionally less than perfect, it doesn't seem to cause him concern.

In the ``Eye on the FDA" column on his website, Grassley says, ``I have made it my business to meddle pointedly within the muddle of the federal bureaucracy." He feigned ignorance when asked about the statement, but if his site says he's a meddler, he allowed, it must be true.

When it comes to Congress, he has a sharp view of its two major functions.

``One, to pass law, and the other one, to make sure the laws are faithfully executed," he said. ``We put too much emphasis on the first one. I don't care about that as much as I do oversight."

Still, he was principal sponsor of the 1989 Whistleblower Protection Act , enacted to help stem defense contractor fraud. The law, which returned more than $12 billion to the US Treasury, also has aided Grassley's investigations into healthcare fraud and the FDA . He has invited FDA and business whistle-blowers to Congress to testify and used their insider knowledge to obtain more information.

``There is no way I would have the resources to go out and find these things we find. People bring them to me," he said. ``That's why whistle-blowers are such an important part of representative government and oversight. They know where the skeletons are buried."

A recent bill Grassley cosponsored would bring that same kind of transparency to clinical trials by mandating publication of results.

A more disputed proposal he cosponsored would create an autonomous Office of Drug Safety at the FDA, separating drug safety reviewers from the Office of New Drugs . A Government Accountability Office investigation of drug safety, requested by Grassley, found the current FDA office responsible for drug safety is under-funded, subject to high turnover, and routinely ignored.

``The way our bill is written, I think it's going to demand more resources. But right now, we've got to get it out with more independence," Grassley said.

Some say his efforts could be the solution to what ails the FDA; others think he's part of the problem.

In response to a Harris Poll released last month that found 58 percent of Americans think the FDA does a fair or poor job of ensuring drugs are safe and effective, a former FDA staffer charged that consumers based their opinions on ``false accusations, slanted half-truths, self-serving pronouncements" about the agency.

``This is what some of our elected public officials hath wrought," Peter Pitts , who once served as associate FDA commissioner , wrote on his blog .

And many career FDA employees say the autonomous drug safety office Grassley wants could create an organization focused on safety but lacking knowledge of how drugs actually work.

``I think Senator Grassley is well-meaning, don't get me wrong," said William Hubbard , a 25-year FDA veteran and former associate commissioner who retired last year. ``I don't think, though, he really has a full understanding of the drug-safety barriers."

Alan Goldhammer, associate vice president for the Pharmaceutical Research and Manufacturers of America , a lobbying group for the drug industry, disagrees with the notion championed by Grassley that the FDA fails to uphold its drug safety mandate.

He has ``largely been focusing on the safety side and whether the drug safety system in this country is broken," Goldhammer said. ``Our view on that is it's not broken."

Others, however, applaud Grassley's ability to shift the media's spotlight onto problematic drugs.

``By focusing public attention on this you create momentum around potentially new legislation to solve some of these problems and get us back on track again," said Dr. Steve Nissen , Cleveland Clinic's cardiology chief . Nissen continues to challenge Merck's characterization that only long-term use of Vioxx raised heart risks. ``I know the FDA probably doesn't like the scrutiny, but I, frankly, think it's healthy," he said.

Over the past five years the FDA has operated with a Senate-confirmed commissioner for just 20 months. Donald Kennedy, a former FDA commissioner, said some of Grassley's ire may have been sparked by the slow pace that has resulted from unstable leadership at the agency's top.

The latest FDA controversy investigated by Grassley involves Ketek , a Sanofi Aventis antibiotic the agency approved despite knowing a clinical trial investigator failed to report patients' side effects , back-dated documents, and falsified data. Grassley is pressuring the FDA to permit the special agent involved in uncovering the misconduct to be interviewed by his staff.

Grassley also has reason to be concerned about his staff's well-being. Last November, his chief investigator, Emilia DiSanto , was attacked outside of her suburban Virginia home. The assailant, dressed in black, clubbed her with what appeared to be a baseball bat. The FBI and Capitol Police are still investigating and no arrests have been made. Grassley suspects DiSanto was targeted because of her work on drug safety and other matters.

``Unless the guy was a psychopath, it doesn't seem to me like it was random," he said. ``If they had knocked her out with the first hit, she'd be dead. She was able to just survive and fight back, and the guy got scared and ran off."

``She's OK," he added, ``but, obviously, we [will] live with this for a long, long, long time."

Diedtra Henderson can be reached at dhenderson@globe.com.