Healthy Skepticism Library item: 710

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Publication type: news

Grassley Plays Up Role as Government Watchdog, Focuses on FDA
Washington Health Policy Week in Review 2004 Dec 20

Full text:

It’s not often a GOP lawmaker’s “to do” list includes investigating the conduct of a Bush administration agency. But Senate Finance Chairman Charles E. Grassley is an exception among Republicans: His forte is government oversight.

While Republican colleagues focus on reducing the size of government, the plain-speaking 71-year-old favors playing government watchdog. His dogged pursuit of the nursing home industry, for example, exposed horrendous conditions for patients and lax federal and state oversight that has led to changes that have improved patient care.

The Iowa lawmaker is now focusing on how the Food and Drug Administration handled the approval process for two blockbuster drugs, Vioxx and Celebrex. And his probe is classic Grassley, with a high-profile hearing, whistleblowing bureaucrats, and agency chiefs on the hot seat. It also has irked some in the Bush administration.

Whistleblowers call his staff regularly, in part because of Grassley’s defense of employees such as Dr. David Graham, a reviewer in the FDA’s Office of Drug Safety, who said agency officials tried to suppress his research about the dangers of Vioxx. Vioxx was a best-selling painkiller until its manufacturer, Merck & Co., withdrew the drug from the market in September after it was linked to an increased risk of stroke and heart attack.

Grassley’s work so far on Vioxx – which includes an ongoing investigation and a recommendation that an independent panel is needed to improve the safety of the nation’s drug supply – suggests that the pharmaceutical industry may be in for the same kind of treatment the nursing home industry endured on Grassley’s watch.

So far, the administration has not supported Grassley’s inquiry. Appearing on the ABC television program “This Week,” White House Chief of Staff Andrew H. Card, Jr., said the FDA does “a spectacular job” and that the agency lives up to the “expectation of improving health care.”

Card was also negative on Grassley’s panel idea. “I don’t know that we need a commission,” Card said.

Standard Operating Procedure

It’s a standard formula: Let the staff zero in on an explosive issue, pursue it with vigor and see it through to the end. Congressional observers say Grassley’s pursuit of the FDA is similar to the strategy used for years by oversight-savvy lawmakers, including Rep. John D. Dingell, D-Mich., who is remembered by Republicans and Democrats as one of the most aggressive investigators in Congress when Democrats ran the House. “This is just the way (Grassley) is,” a former administration official said. “You see an issue, you load him up and go for it.”

Other Republicans ask why Grassley is so intent on investigating activities within a GOP administration. Grassley just won reelection by a wide margin, Bush won a second term, and Republicans picked up seats in both chambers. Why rock the boat?

Grassley aides dismiss accusations that the five-term senator stays with broader themes during such investigations – such as being the guardian of taxpayers’ dollars – and is not interested in the details. “He read the (FDA) e-mails, he saw the studies” that are part of the Vioxx investigation, one aide said.

Aides also discount charges that Grassley’s oversight activities are done mostly to generate press attention or score political points. They cite the panel’s ongoing investigation and Grassley’s plans to introduce legislation next year that would give the Office of Drug Safety more independence within the FDA.

“Sen. Grassley gives us the leeway to pursue things,” an aide said. “But he has said many times, ‘You don’t count votes on oversight, you just put it out there.’ “

Sometimes exposing potential wrongdoing can be the catalyst to correct problems, Grassley says. “Congressional oversight can shed disinfecting sunlight. It can result in accountability and necessary reforms for the public good,” he said as he convened the Vioxx hearing in November.

Grassley has also said he enjoys oversight because trying to drive change through legislation is a slower process. “With oversight, it’s direct and immediate, and you see results much more quickly,” Grassley said in Congressional Quarterly’s 2004 edition of “Politics in America.”

Nursing Homes Under Fire

As Finance chairman and in his previous post as head of the Senate Special Committee on Aging, Grassley has used his tenure and jurisdiction to highlight problems with nursing homes.

Since 1997, Grassley has pushed to improve and enforce higher standards of care provided at the nation’s 17,000 nursing homes. A 1998 General Accounting Office report he requested found that there were seriously quality-of-care problems in approximately 30 percent of nursing homes in California and raised concerns that similar quality-of-care problems existed in other states.

That report prompted efforts by the federal government to improve oversight by state and federal agencies, and a subsequent GAO report in 2003 found that nursing home care improved nationwide, although problems exist in some areas.

In July, Grassley said a Department of Health and Human Services Inspector General report, which found flaws in a federal Web site rating the performance of every Medicare- and Medicaid-certified nursing home in the country, validated earlier reports from Grassley’s staff that found problems with how federal and state governments determine if there are problems with the quality of care in nursing homes.

“It is apparent from our review that the survey and certification processes upon on which we rely for accurate, objective and independent data on the operation and activities of facilities is just plain broke,” Grassley wrote to Centers for Medicare and Medicaid Services Administrator Mark B. McClellan.

Grassley has a track record of reaching across the aisle to accomplish his goals. Sen. Max Baucus, D-Mont., is a frequent collaborator – the two worked together on the conference committee that wrote the Medicare prescription drug law (PL 108-173). In April, Grassley partnered with Rep. Henry A. Waxman, D-Calif., to send a letter to HHS Secretary Tommy G. Thompson asking the government to report on the use of feeding assistants in nursing homes and provide more accurate data to the public about nursing home staffing.

Jurisdictional Squabbles

As the Finance panel prepared to convene its Vioxx hearing in November, some questioned why the panel was even getting involved in FDA issues.

Traditionally, the Senate Health, Education, Labor and Pensions Committee has jurisdiction over the FDA. But since the Finance panel has jurisdiction over Medicare and Medicaid – and Medicaid had paid in excess of $1 billion for Vioxx while it was on the market – Grassley seized the initiative with the issue.

“Congress has a constitutional duty to conduct oversight of the executive branch of government,” Grassley said.