Charles Grassley

Emory psychiatrist accused of not reporting drug company income

Anne Zieger — Mon, 06 Oct 2008 09:49:25 -0400

A high-profile Emory University psychiatrist has been accused of failing to report one-third of the $2.8 million in consulting fees he received from companies whose drugs he was evaluating, according to Congressional investigators. The psychiatrist, Dr. Charles Nemeroff, got the money from GlaxoSmithKline between 2000 and 2007, while he was principal investigator on a $3.9 million NIH study of five Glaxo drugs used for treatment of depression, investigators said. Nemeroff is the sixth psychiatrist named as facing similar conflicts of interest since the Congressional probe began.

According to Congressional researchers, Dr. Nemeroff continued to get large amounts of money for giving speeches to other doctors, despite having signed University documents pledging to accept no more than $10,000 a year from any one company. Since the allegations were revealed, Nemeroff has stepped down as chairman of Emory's psychiatry department.

The ongoing investigation of such conflicts of interest is being spearheaded by Sen. Charles Grassley (R-IA), who is promoting a bill that would require pharmaceutical and medical device companies to disclose all payments over $500 they make to physicians.

To learn more about these allegations, and the ongoing investigation:
- read this Los Angeles Times piece

Related Articles:
Harvard psychiatrists fail to reveal millions in pharma pay
Psychiatrists getting the largest pharma gifts
Bill would make pharmas, device makers disclose gifts

Non-profit hospital tax breaks attacked by Grassley, again

Wed, 11 Jun 2008 06:59:56 -0400

Well, folks, if you thought Sen. Chuck Grassley (R-Iowa) was ready to take a breather on the subject of non-profit hospital tax breaks, think again. This week, the Senator used a hearing on incentives for lowering the rates of the uninsured and under-insured in the U.S. to bring the topic up again. At the hearing, which was held by the Senate Finance Committee, Grassley had a 53-year-old leukemia patient testify about her experience with the M.D. Anderson Cancer Center, which demanded a total of $105,000 in cash up front before it would provide chemotherapy.

In discussing the issue, Grassley noted that M.D. Anderson is a non-profit "funded through taxpayers' dollars and charitable gifts," making its actions particularly troubling. As he has many times in the past, Grassley hinted that non-profit tax breaks could be in danger if the hospitals engage in this type of billing practice.

Among other things, Grassley has also proposed that rules be enacted to set minimum levels of charitable spending a not-for-profit would be required to make to keep its tax-free status. Meanwhile, the IRS is taking a closer look at such issues as it rolls out its Form 990, Schedule H, which will require detailed reporting on charitable spending by hospitals.

To learn more about Grassley's discussion at the hearing:
- read this Wall Street Journal blog item

Related Articles:
Senator may seek tougher charity rules for nonprofits
Senator wants nonprofit hospital investigation
IRS to investigate nonprofit hospitals
Charity care under fire

Drug companies plan to disclose grant funding

Fri, 11 Apr 2008 06:59:58 -0400

Hoping to stave off outside regulation by Congress, a group of the nation's largest drug and device manufacturers have put forth plans to publicly disclose the grants they make to outside organizations. In a recent letter to 15 such companies, Sen Chuck Grassley (R-IA) noted that Eli Lilly already discloses the grants it makes for continuing medical education programs, and asked them to explain why they weren't making similar efforts.

In response to Grassley's letter, virtually all of the companies outlined disclosure plans, though the plans differ in the details. For example, Medtronic said it will post payments for professional meetings and patient groups on its site beginning May 1, and AstraZeneca will follow its lead starting Aug. 1. Boston Scientific, for its part, said it would soon disclose certain payments to physicians, a particularly newsworthy concession. The only holdout was Schering-Plough, which told Grassley that it didn't have plans to publish its charitable contributions anytime soon.

Sen. Grassley, along with Sen. Herb Kohl (D-WI) already have introduced legislation that would require drug and device makers to disclose anything of value given to doctors, including not only payments, but also gifts and travel. However, they're really hoping to see these industries disclose medical education payments, too.

To learn more about the drug and device makers' plans:
- read this Associated Press piece

Related Articles:
Senate investigates pharma influence on CME
Case study: NY hospital drops pharma CME funding
SPOTLIGHT: Pharma's influence in continuing medical education.
Doctors weigh in on the pros and cons of accepting drug/device freebies

Congress says drugmakers held back Vytorin data

Tue, 01 Apr 2008 07:59:58 -0400

Cholesterol drug Vytorin--and makers Merck and Schering-Plough--have been under fire for months since a study suggested that the expensive combo med works no better than much less costly Zocor. Things became even hotter when it came to light that the American Heart Association was vouching for Vytorin despite the study results, perhaps because it gets almost $2 million a year from Merck and Schering-Plough. Now, Vytorin is under fire from a Senate Finance Committee, which has released evidence suggesting that Merck and Schering-Plough delayed negative research data from a test of Vytorin vs. cheaper statins to avoid a drop in the drug's sales.

In a letter to the pharmas, Sen. Chuck Grassley (R-IA) notes that while the results of the study, known as ENHANCE, remained in the can, the companies spent about $3.5 million on a marketing campaign to get doctors to switch patients to Vytorin from cheaper drugs.

To learn more about the latest Vytorin controversy:
- read this Associated Press piece
- read Sen. Grassley's letter to the drug companies (.pdf)

Related Articles:
AHA backs costly cholesterol drug combo. Report
Vytorin defenders funded by drug makers. Report
Vytorin, Zetia scrips plummet. Report
Heart docs back Vytorin. Report

GAO to study FDA's post-approval review process

Wed, 05 Mar 2008 06:59:58 -0500

Prompted by calls from Sen. Charles Grassley, the Government Accountability office has set plans to review the current method by which the FDA approves some drugs, including challenged medications like diabetes drugs Avandia and cholesterol drug Vytorin. Right now, the agency bases some approvals on "biomarkers," measurable responses in patients which are believed to predict other outcomes. For example, Avandia was approved because it lowered blood sugar, which was believed to lower heart attack risk, a much quicker route than waiting years to see if patients actually had the heart attacks. Since then, however, research has suggested that Avandia actually raises such risks.

Advocates say using biomarkers is appropriate for several reasons. Among other things, they say the longer trials needed to actually find events like heart attacks might jeopardize patients, as some would have to take a placebo for long stretches. Meanwhile, some critics say using biomarkers isn't necessarily the problem. They contend that the real concern is that the FDA doesn't require follow-up studies which would investigate whether drugs like Avandia and Vytorin delivered on their promised benefits.

To learn more about this issue:
- read this Associated Press piece

Related Articles:
Biotechs eager for FDA approval of biogeneric drugs. Report
FDA streamlining drug approval process. Report
Researcher challenges FDA approval process. Report
Report faults FDA's post-marketing vigilance. Report

Ohio AG working to define charity care

Fri, 01 Feb 2008 06:59:57 -0500

Ohio Attorney General Marc Dann has kicked off an initiative under which he plans to better define what the state's not-for-profit hospitals must do to keep their state property tax exemption. Among other things, Dann wants to see poor and uninsured patients pay no more than insurance companies pay for care. As part of the initiative, Dann plans to hire experts to study charity care issues and look at what other states are doing. He's interested, for example, in a Minnesota accord under which hospitals agreed not to use abusive debt collection practices or charge uninsured patients more than insurance companies. He also plans to examine the efforts made by Sen. Chuck Grassley (R-Iowa), who, as FierceHealthcare readers know, has been all over the issue of hospitals' charity care levels for years. His initiative comes as several Ohio communities have begun questioning the tax-exempt status of their local not-for-profit hospitals. For example, one community is challenging the tax exemption enjoyed by a Beachwood, OH facility run by the Cleveland Clinic, arguing that it provides no charity care or other community benefits.

To find out more about Ohio's initiative:
- read this piece in The Plain Dealer

Related Articles:
Case study: Another battle over charity care. Report
VHA: Charity policy must come from the top. Report
Time to prove community benefit. Report
A new standard for voluntary hospitals? Report

MD leaked Avandia results to GSK

Thu, 31 Jan 2008 06:59:58 -0500

A physician with a previous financial relationship with GlaxoSmithKline has apparently admitted that he leaked a study critical of Avandia's safety to drugmaker GlaxoSmithKline two weeks before it was published in a major journal. The physician, Dr. Steven Haffner of the University of Texas Health Science Center in San Antonio, had agreed to read the article as part of The New England Journal of Medicine's peer-review process. Under the NEJM's rules, reviewers are not allowed to disclose the contents of an article to anyone prior to its publication.

Since the disclosure came to light, Sen. Charles Grassley (R-Iowa) has blasted Dr. Haffner in a public statement; the Senator also sent a letter to Glaxo asking the company what action it took after receiving the letter. In an article published in the journal Nature, Dr. Haffner seems to admit to the truth of the accusation, saying: "Why I sent it is a mystery. I don't really understand it. I wasn't feeling well. It was bad judgment." Dr. Haffner has previously disclosed that he conducted research and served as a paid speaker for the drugmaker.

To learn more about the leak:
- read this piece in The New York Times

Related Articles:
Avandia gets black-box warning. Report
Avandia controversy sparks FDA criticism. Report
Glaxo: Avandia's safe as other diabetes drugs. Report
Avandia critic: FDA launched smear campaign. Report
Diabetes expert issued harsh Avandia critique in 2000. Report

Feds to crank up non-profit charity demands

Wed, 02 Jan 2008 06:59:58 -0500

Watch out, charity hospitals--Sen. Chuck Grassley is coming after you. In recent times, the Iowa Senator has been on the warpath over what he considers to be inadequate levels of charity care provided by hospitals--and has even had staff draft a proposal which would require hospitals to dedicate 5 percent of annual patient operating expenses or revenues to charity care. Meanwhile, the IRS is making changes to not-for-profit reporting forms which would ask hospitals to do more detailed reporting on the community benefits and charity care they provide. States, while less aggressive, are certainly keeping their eye on the issue. And don't forget advocacy groups--they're on the case, too.

Sure, this isn't a new thing. In fact, the IRS and legislators have been posturing on this subject for years. But my sense is that non-profit charity standards will be under particularly intense scrutiny this year. Look for other parties to insert themselves into the charity care/benefit debate in '08, including more state regulators. And if you're a not-for-profit hospital, make it a priority to document what you do in more detail than you ever have. Glossy brochures, happy talk and PowerPoints alone aren't gonna cut it.

AHA makes headway on community-benefit reporting

Mon, 12 Nov 2007 06:59:58 -0500

The American Hospital Association has won broad support from the U.S. House of Representatives in its attempt to change the IRS's proposed community-benefit reporting rules. More than 300 members of the House are backing the AHA's campaign to change the IRS's proposed requirements, which would come as part of changes to the agency's Form 990 annual filing form for not-for-profits.

While the IRS's current draft of Form 990 doesn't do so, the AHA would like to see the IRS include bad debt and Medicare losses as part of community-benefit reporting. In a letter to the IRS urging the changes, lawmakers are also asking the IRS to put off adopting the community-benefit reporting policy until 2010. Otherwise, it should go into effect as soon as early 2008.

The AHA may have some support for this effort, but it's worth noting that such protests have at least one major detractor as well. Senate Finance Committee Chairman Chuck Grassley (R-IA) has strongly challenged the hospital industry's efforts to frame charity reporting differently. Grassley has repeatedly called for investigations into whether not-for-profits are doing enough to merit their federal tax exemption.

To learn more about the debate:
- read this Modern Healthcare article (reg. req.)

Related Articles:
AHA charity proposal draws Congressional criticism. Report
IRS says 'uncompensated care' definition is dicey. Report
IRS to investigate nonprofit hospitals. Report
Proving community benefit by reducing sickness. Report
A critical time to prove community benefit. Report
A new standard for voluntary hospitals? Report
VHA: Charity policy must come from the top. Report

Congress to investigate investor-owned nursing homes

Wed, 24 Oct 2007 06:59:58 -0400

As we reported yesterday in FierceHealthcare, giant investment firm The Carlyle Group is taking steps to head off critics of its $6.3 billion acquisition of long-term care player Manor Care. Responding to pressure from unions representing Manor Care's workers, Carlyle sent letters to state regulators pledging that it would hire enough staff, train them well and make proper infrastructure investments in its homes. This gesture, however, apparently wasn't enough to impress some Congressmen, who have begun an inquiry into not only Carlyle, but business practices at investor-owned nursing homes generally. They're investigating widespread allegations that private equity firms cut staff to the bone while remaking corporate structures to avoid getting sued when patients are harmed.

Reps. John Dingell (D-MI) and Barney Frank (D-MA) are planning hearings on the topic, and most likely legislation as well. This follows action by Sens. Max Baucus (D-MT) and Charles Grassley (R-IA), who have sent letters to five private investment firms asking for information on their ownership structure and management practices. Baucus and Grassley also asked CMS for information on its oversight of nursing homes.

The concern on the The Hill isn't unique. Earlier this month, officials in Florida, Illinois, Pennsylvania, Michigan and Washington asked regulators to investigate the Carlyle acquisition--and to withhold approval of the deal until they did so.

To learn more about this investigation:
- read this piece from The New York Times

Related Articles:
Manor Care buyer puts staffing promises in writing. Report
Manor Care goes private in $6.3 billion deal. Report
Genesis HealthCare to go private. Report