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Published: November 19, 2008

WASHINGTON — Former President Bill Clinton has agreed to all of the conditions sought by President-elect Barack Obama’s transition team to eliminate potential conflicts of interest if Senator Hillary Rodham Clinton becomes secretary of state, people close to the Clintons said Wednesday.

Mr. Clinton accepted several restrictions on his business and philanthropic activities to remove any obstacle to his wife’s nomination if the cabinet job is formally offered and accepted, said the associates, who insisted that they not be identified because they were disclosing confidential negotiations. “I’ll do whatever they want,” Mr. Clinton said Wednesday at a public appearance.

The discussions came as Mr. Obama moved forward in putting together the team he will bring to office in January. Mr. Obama has decided to nominate Tom Daschle, the former Senate Democratic leader, as secretary of health and human services, Mr. Obama’s advisers said Wednesday. Mr. Daschle has accepted the offer, which would make him a point man in Mr. Obama’s ambitious plan to expand health care coverage.

Although Mr. Daschle’s nomination will not be officially announced for a while, the transition team did make public several expected White House appointments on Wednesday. They included David Axelrod, who was Mr. Obama’s chief campaign strategist and now will serve as senior adviser to the president, and Gregory B. Craig, who was Mr. Clinton’s impeachment defense lawyer and now will serve as White House counsel.

But Washington continued to be gripped by the drama surrounding Mrs. Clinton’s fate and the possibility that Mr. Obama might bring his toughest rival for the Democratic presidential nomination into his cabinet. Mr. Obama’s advisers said the talks had gone well, but would not say if an agreement to avoid conflicts had been reached, as the Clinton camp has indicated.

Even if the guidelines for Mr. Clinton’s future activities are on the verge of being resolved, Mr. Obama and Mrs. Clinton must still decide if they can put the rancor of their long and bitter primary battle behind them. The two sides have a framework on “what he needs to do to satisfy the vetting concerns and that gives her an opportunity to consider the job on the merits,” said one person close to the Clintons.

Both sides were engaged in a delicate public and private dance, maneuvering for position and reputation in case the deal falls through. Aides in each camp have grown increasingly sour toward the other in recent days as the matter played out publicly.

In their public signals, the Clintons are trying to take the former president’s activities off the table as an issue, in their view eliminating any excuses for Mr. Obama not to give Mrs. Clinton the job. Some in the Obama camp are bristling at what they see as strategic leaks by the Clintons aimed at boxing in the president-elect and forcing him to offer the post.

The tension could foreshadow a complex relationship burdened by suspicion and enmity should Mrs. Clinton become secretary of state. By putting her in the cabinet, Mr. Obama could remove a potential thorn in the Senate on issues like health care and a potential rival for the nomination in 2012 if his term proves rocky. But he could also face a rival power center within his own administration with her on his team.

In discussions over the last few days, Mr. Clinton has agreed to disclose some major donors to his charitable foundation and to subject his future foundation activities and paid speeches to review by the White House counsel’s office and the State Department ethics office, according to Democrats close to the negotiations. He would step back from day-to-day responsibility involving the William J. Clinton Foundation and alert the State Department to speaking plans and new income sources.

The Wall Street Journal first reported his concessions. Advisers to both Mr. Obama and the Clintons confirmed them on Wednesday. Clinton advisers added that the former president had met all of the conditions sought by the Obama team and said he would meet any others that might still be presented.

“I’m certain President Clinton will do whatever it takes, which means whatever President-elect Obama wants, to make the nomination acceptable, if he offers and she accepts,” said Lanny J. Davis, a longtime Clinton friend who was special counsel in his White House and has consulted the Clinton camp in recent days.

Asked about the situation at a ceremony in New York renaming the Triborough Bridge after Robert F. Kennedy on Wednesday, Mr. Clinton pledged the same without elaboration. “Whatever they want,” he said. He added that it was between the president-elect and his wife. “You should talk to them. I’ll do whatever they want.”

Mr. Clinton is being represented in the talks by his longtime aides, Cheryl D. Mills, Bruce R. Lindsey and Douglas J. Band. Mr. Obama is being represented by John D. Podesta, his transition co-leader; Todd Stern, a deputy to Mr. Podesta, and Thomas J. Perrelli, a Harvard Law School classmate of Mr. Obama’s. Reflecting the complex entanglements of the negotiations, all three of Mr. Obama’s representatives served in Mr. Clinton’s administration.

In picking Mr. Daschle for health and human services, Mr. Obama is seeking to install a close ally and early supporter of his run for the presidency. Although no announcement will be made until after Mr. Obama first unveils his economic and national security teams, the transition office announced Wednesday that Mr. Daschle would also oversee a health policy working group to develop a health care plan.

That could address what Mr. Daschle’s friends said was a condition for considering the cabinet job, his insistence that he not just be the head of a huge bureaucracy but a chief player on the subject he has literally written a book on.

In “Critical: What We Can Do About the Health-Care Crisis,” published in February, Mr. Daschle proposed creating a Federal Health Board, similar to the Federal Reserve System, and merging employers’ plans, Medicaid and Medicare with an expanded federal employee health benefits program to provide universal coverage.

Mr. Daschle’s former colleagues on Capitol Hill embraced his selection. “President-elect Obama quite simply could not have made a better choice for the job,” said Senator Ron Wyden, Democrat of Oregon. Senator Charles E. Grassley, a senior Republican from Iowa, called it “a big step forward” because Mr. Daschle understands the Senate.

Democrats signaled they would press ahead on an overhaul of the health care system despite the current economic crisis. Senators Edward M. Kennedy of Massachusetts and Max Baucus of Montana convened a meeting of their colleagues to plot strategy. “All are dedicated toward getting meaningful health care reform enacted in this next year,” Mr. Baucus said afterward. He said lawmakers intended to “hit the ground running in January.”

But that will prove harder than it sounds, health care experts said, and even Mr. Obama aides acknowledged that it would be difficult to scrape together the money for such an overhaul given the economy. “We’re not going to have enough money for a lot of things,” one Democratic adviser to Mr. Obama said.

While attention focused on Mr. Obama’s emerging cabinet, the president-elect filled out more of his White House staff. Aside from Mr. Axelrod and Mr. Craig, the Obama transition announced that Lisa Brown, former counsel to Vice President Al Gore, would serve as staff secretary and Christopher P. Lu, a top aide in Mr. Obama’s Senate office, would be cabinet secretary.

 



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Home arrow Blog arrow FDA panel: Lower maximum daily dose of Tylenol
FDA panel: Lower maximum daily dose of Tylenol PDF Print E-mail
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Tuesday, 30 June 2009

ADELPHI, Md. (AP) — Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But over-the-counter cold medicines — such as Nyquil and Theraflu — that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

"I think it's a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis," said Linda Suydam, president of the Consumer Healthcare Products Association.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.

But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

"If we don't eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines," said Sandra Kewder, FDA's deputy director for new drugs, summarizing the panel's vote.

Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.

If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.

Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

"The panel recommending banning Vicodin and Percocet seems a little draconian," said Les Funtleyder, an analyst for Miller Tabak & Co.

Drug companies avoided the most damaging potential outcome with the defeat of proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.

These drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, according to the FDA, but cause only 10 percent of acetaminophen-related deaths.

"I don't think we should be advocating a solution to a problem that really is not there," said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

A recall of combination cold medicines would have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

"The acetaminophen people dodged a bullet," said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Even with the lower daily dosage recommendation, consumers will likely keep taking as many pills as they think they need to ease their pain, Gordon said.

Analyst Steve Brozak of WBB Securities said the panel votes were a "shot across the bow" of the pharmaceutical industry.

"This basically puts more government oversight into something that heretofore has been less than present," Brozak said.

AP Business writers Stephen Manning and Donna Borak contributed to this report.



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