Primary Arterial Hypertension News - Menu Lung criteria changes will happen soon
By Libby Keeling / Courier & Press
March 7, 2005 - Before his lung transplant in December, Steve Sparks hoped he would live long enough to see his daughter, Sage, celebrate her second birthday. Now that his body is rejecting the transplanted lung, he is praying simply to see "tomorrow." "There's a lot of stuff I want to do, but I don't want to be greedy," he said during a telephone interview from Methodist Hospital in Indianapolis.
Sparks, a 55-year-old Evansville resident, suffers from primary pulmonary hypertension, a rare lung disease. Courier & Press staff writer Ella Johnson introduced Sparks to readers in January. Now he wants people to know that the lung allocation process is changing. The United Network for Organ Sharing and the Organ Procurement and Transplantation Network revised the U.S. lung allocation policy in June. Implementation of the new criteria is anticipated this spring. "You want to minimize the possibility of rejection. I think you'll have better outcomes," said James Wide, public relations coordinator with the Clarian Transplant Center, which includes Methodist Hospital, Riley Hospital for Children and Indiana University Hospital, all in Indianapolis. When Sparks received his transplanted lung at Methodist, the allocation determination essentially was based on his position on the waiting list and blood type, he explained. The existing policy also considers the proximity of the donor hospital to the transplant center. According to UNOS, the policy revisions for patients age 12 and older are intended to balance how long a person can survive on the transplant list with how long the person will benefit from receiving a transplant. The new guidelines, similar to those for livers, will consider a variety of criteria, Wide said, including severity of illness, potential success, age, blood type and other diagnostic outcomes. Patients most urgently in need and those expected to receive the greatest survival benefit will receive transplant priority. Sparks was third on the waiting list when he received his transplant. He said he was allocated the lung because the two people ahead of him were not blood-type matches. He's not sure what would have happened if the new policy had been in place at the time. "If someone is No. 3 on the list and they come in and say, 'Now you're 120,' that's scary," Sparks said. "They're really going to need support just to keep them up enough to get to the transplant point." If more people would donate organs, the allocation process would not be so complicated, he said. Sparks is hoping revisions in the policy will persuade more people to donate. "I think with it going this way it's going to help ensure a higher survivor rate, which will in turn show people it really does matter, that by donating organs they can save somebody's life," he said. Since receiving the transplanted lung Dec. 10, Sparks has been fighting rejection, infection, drug side effects and depression. He recently completed a 14-day anti-rejection treatment, and said doctors are optimistic that the moderate rejection process has been stopped. "It's taking everything I've got to hang on," he said. "And then emotionally, that's more than 50 percent of the battle."
Sparks said his fiancee, Debbie Walrath-Williams, and six children buoy his spirits, which often lag as he perseveres in the physical and emotional battle. "You have to push yourself until you can't and then push some more," Sparks said. "You can't do it by yourself. You have to have the emotional support of your family and friends."
FDA Advisers Endorse Stronger Warnings for Embattled Asthma Drugs
By Peggy Peck, Senior Editor, MedPage Today
Also covered by: Forbes, Fox News
ROCKVILLE, Md., July 15-FDA advisers have recommended that the asthma drugs Advair (fluticasone propionate/salmeterol), Foradil (formoterol), and Serevent (salmeterol) remain on the market but with beefed-up warning labels.
The FDA's Arthritis Drugs Advisory Committee said a black box warning about risk of severe asthma exacerbations should be added to the Foradil label.
Advair and Serevent already contain boxed warnings about the risk of asthma exacerbations, but the advisory committee recommended an update to include a warning about an increased risk of respiratory-related deaths.
The drugs had been under a microscope since a Congressional hearing last year where David Graham, M.D., M.P.H., the associate director for science in the FDA's Office of Drug Safety, named Serevent as a drug with serious outstanding safety concerns.
Following a daylong review of the latest safety data on the drugs, the committee voted 12-0 to recommend keeping the drugs on the market.
All three products are indicated for use as bronchodilators in patients with asthma and chronic obstructive pulmonary disease as maintenance treatment. All salmeterol products -- Serevent and Advair included -- carry a black box warning detailing the rare risk of severe asthma exacerbations based on findings form the Salmeterol Multicenter Asthma Research Trial (SMART).
Prior to the advisory committee meeting, an FDA analysis of Serevent safety data from the SMART trial and follow-up data from GlaxoSmithKline, which makes Serevent and Advair, found a greater relative risk of adverse events than was reported by the company in its own analysis of the post-marketing data. African-Americans, according to both analyses, have an even greater risk of adverse events.
The FDA did not find a statistically significant difference between Serevent and placebo in the SMART trial's primary endpoint, combined respiratory-related deaths or respiratory-related life-threatening experiences (relative risk 1.40: 95% confidence interval 0.91, 2.14).
However, the FDA analysis found a statistically significant increase for three secondary endpoints: asthma-related deaths (4.37: 95% CI 1.25, 15.34), respiratory-related deaths (2.16: 95% CI 1.01, 2.89), and combined asthma-related deaths or life-threatening experiences (1.71: 95% CI 1.01, 2.89).
In a report to the advisory committee, FDA scientists wrote, "Analyses of secondary endpoints suggested that patients receiving salmeterol may be at increased risk" for respiratory-related deaths. This is a caution that the advisory panel said should be added to the black box warning.
The FDA also studied data from a Phase III trial of Foradil, which is in the same drug class as Serevent, and found that asthma exacerbations increased at higher doses (24 µg bid versus 12 µg bid). But the FDA scientists said the event rate in the study was too small to draw any firm conclusion.
Panel member Steven Gay M.D., a pulmonologist at the University of Michigan and a member of the committee, concluded that "until proven otherwise, we have to make ourselves believe that Foradil may act the same way as salmeterol." Thus, he said, the panel unanimously recommended the black box warning for Foradil.
Challenge to lawyer fees to proceed in fen-phen case
By Andrew Wolfson
awolfson@courier-journal.com
The Courier-Journal
April 13, 2006 - BURLINGTON, Ky. -- A lawyer for three attorneys accused of deceiving their clients in Kentucky's fen-phen case said yesterday that they shouldn't be held liable for overpaying themselves because they were acting on a judge's orders.
William E. Johnson said Lexington lawyers Shirley Cunningham Jr., William Gallion and Melbourne Mills Jr., relied on an order from then-Circuit Court Judge Joseph Bamberger when they paid themselves extra fees and placed $20 million from a $200 million settlement into a charitable trust.
"If you can't trust a court and a court's orders, who can you trust?" Johnson asked yesterday in Boone Circuit Court, where he unsuccessfully tried to persuade Special Judge William Wehr to set aside a ruling that the Lexington attorneys breached their duties to 440 former clients.
Bamberger was publicly reprimanded and forced to resign in February, in part for allowing the lawyers to pay themselves excessive fees. But Johnson argued that the attorneys still had a right to rely on his orders.
Wehr said, however, that the lawyers had a duty to their clients regardless of the judge's rulings. Wehr also said Bamberger may have been misled into believing the clients -- who were injured by the popular diet drug -- approved transferring $20 million of settlement money into what was later named the Fund for Healthy Living.
Nearly all of the former clients -- 421 of them -- have joined in a lawsuit in which they are seeking to force their ex-lawyers and Cincinnati attorney Stanley Chesley into surrendering part of their fees. Each received more than $20 million.
Wehr, who is presiding over that lawsuit, ruled last month that the Lexington lawyers are liable. Yesterday he declined to dismiss Chesley from the case but also rejected the plaintiffs' motion to summarily find that Chesley breached his duties.
Chesley, a nationally known class-action lawyer, insists he was brought into the case by the Lexington lawyers solely to negotiate a settlement and had no direct contact with clients nor any duty to them.
Chesley, who was paid 21 percent of the gross fees awarded to the other lawyers, said through his attorney that, if those lawyers are found to have been overpaid, he would surrender any excessive fees he received because of their overpayment.
Johnson said he intends to appeal Wehr's ruling that the Lexington lawyers breached their fiduciary duty. Robert Sanders, an attorney for the Fund for Healthy Living, said he would appeal Wehr's ruling freezing the money in that fund.
Wehr gave the defendants 10 days to respond to a motion filed by the plaintiffs' lawyer, Angela Ford, to place misappropriated funds with a receiver until the court determines how much the attorneys should have to forfeit.
Ford alleges that $64.4 million was misappropriated.
Reporter Andrew Wolfson can be reached at (502) 582-7189.
| 
