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Fen Phen and Primary Arterial Hypertension News September
3 plead guilty in Fen-Phen probe Trio from Fayette among 12 charged in settlement scheme By Jimmie E. Gates
jgates@clarionledger.com
September 22
Less than a month after being accused of filing phony claims in a $400 million Fen-Phen diet-drug settlement, three of 12 Fayette residents charged in the scheme pleaded guilty Tuesday. In a plea deal, the three agreed to cooperate with an ongoing federal investigation dating to the 1999 settlement against the drug maker. Lizzie Hammett, 52, and Regina Green, 56, pleaded guilty in U.S. District Court in Jackson to one count each of tax evasion. John Frye, 60, balancing himself with a silver walking cane, pleaded guilty to one count of tax evasion and one count of conspiracy to commit wire fraud. Each faces a maximum sentence of five years in prison and a $100,000 fine on the tax evasion charge. Frye faces an additional five years and $250,000 fine on the conspiracy charge. District Judge William Barbour set Dec. 3 for sentencing. He allowed the trio to remain free on personal recognizance bonds. United States Assistant Attorney John Dowdy said the extent of cooperation with the government investigation will ultimately determine the sentencing recommendation. Federal prosecutors agreed to recommend lighter sentences in exchange for the defendants' cooperation. When asked by Barbour if they were guilty, all three responded, "Yes sir." Following their plea, Hammett and Green wouldn't comment. Frye left through a side door of the federal courthouse and could not be reached for comment. Green's attorney, Wayne Dowdy — a relative of John Dowdy — said his client is "a nice lady, and she admits she made a mistake. She is cooperating with authorities." Hammett's attorney, William Baxley, called his client's dilemma "unfortunate." Frye's attorney, George Holmes, declined comment. A joint investigation by the FBI and IRS led to charges Aug. 31 against the 12. Each initially faced conspiracy charges in connection with the settlement from American Home Products, the maker of the diet drug combination Fen-Phen. All are accused of receiving at least $250,000 in settlement funds through false prescriptions, netting about $150,000 after attorney fees and expenses. Hammett and Green face tax evasion charges for submitting 2000 tax returns without listing the settlement money. If money is obtained fraudulently in medical cases, it is taxable, officials said. Frye got an extension of his 2000 federal tax return and didn't submit it until 2002. He also didn't list the settlement money. The conspiracy charge stemmed from submitting a false claim. All three agreed to forfeit property up to $250,000 purchased with settlement money.
Court approval sought for settlement of up to $40 million for Ponderal and Redux national class action TORONTO, Sept. 16 /CNW/ - Lawyers representing Canadians (excluding those residing in Quebec) who ingested the diet drugs, Ponderal and Redux, today announced that Court Approval will be sought October 18 and 19, 2004 of a
national class action with the Defendants Servier Canada Inc. and related companies. If the settlement is approved, settlement funds of $25,000,000 would be made available for the payment of benefits, health insurer costs and legal fees, with an additional amount of up to $15,000,000 being made
available should the initial fund be insufficient.
The settlement, if approved, will pay benefits to individuals who took these drugs and suffered from Valvular Heart Disease ("VHD") or Primary Pulmonary Hypertension ("PPH"), both of which have allegedly been associated with ingestion of the drugs. A parallel settlement was reached in proceedings brought on behalf of residents of Quebec where Court Approval is pending. Ponderal and Redux were withdrawn from the Canadian market in September 1997.
The national class is represented by the Toronto law firm of
Rochon Genova LLP and residents of British Columbia are represented by the Vancouver law firm of Klein Lyons.
The settlement, which is subject to court approval, was reached under the supervision of the Mr. Justice Warren K. Winkler of the Ontario Superior Court of Justice and was made without admission of liability on the part of the
Defendants. A hearing will be held in Toronto before Mr. Justice Peter A. Cumming on October 18 and 19, 2004 to determine whether the Class Action settlement should receive approval. Notices of the Settlement Approval Hearing are to be published throughout the country in the coming days. Steps are being taken to give effect to the settlement of similar litigation in Quebec. For further information: please contact Class Counsel for the national class at Rochon Genova LLP at 121 Richmond Street W., Suite 903, Toronto, Ontario, M5H 2K1, (416) 363-1867, or toll-free at 1-866-881-2292, (416) 363-0263 or visit www.rochongenova.com, or contact Class Counsel for the
British Columbia subclass at Klein Lyons at 1333 West Broadway, Suite 1100, Vancouver, British Columbia, V6H 4C1, (604) 874-7171 or toll free at
1-800-468-4466 or visit www.kleinlyons.com.
7-year-old overcomes rare condition
Local child fights primary pulmonary hypertension
By SUE SOWARDS
Advocate Correspondent Jared was born with primary pulmonary hypertension and was finally taken off his infusion pump last year. MADISON TOWNSHIP -- He has his father's lanky frame, his mother's large hazel eyes and the sweet cheerfulness of a happy 7-year-old. No one knows where Jared Fracker, of Madison Township, got his rare, usually disabling or fatal disease. It has a dauntingly cumbersome name, primary pulmonary hypertension, a progressive disease of unknown cause that results in the narrowing of the blood vessels in the lungs, causing high blood pressure and eventually leading to heart failure, according to the American Lung Association. Jared, a second-grader at Madison Elementary School, has so far beat the odds. In 2000, there were 3,065 deaths attributed to PPH, according to the ALA. Dramatically improved, he is now just as active as other children, and no one would guess he is sick, his parents, Brian and Brenda Fracker said. Brian, 38, and Brenda, 35, said the diagnosis of PPH was made when other illnesses, including secondary pulmonary hypertension, were excluded. Jared is unlike most PPH patients, who are young adult females. Normal at birth, a month later Jared became critically ill. He labored for each breath. Taken to Children's Hospital in Columbus, he was put on a ventilator. He had a virus, the doctors said. With medical treatment, he improved. But at three months, the symptoms returned. Struggling for each breath, "He would suck (briefly) on his bottle, then stop and breathe," his mother said recently. Reflecting upon their painful journey, they credit Dr. David Chan, pediatric cardiologist at Children's Hospital in Columbus, along with Dr. Robyn Barst of New York Presbyterian Pulmonary Hypertension Center, with Jared's recovery. When Dr. Chan diagnosed Jared, the Frackers were devastated and scared. "Dr. Chan said Jared was in bad shape" and he'd only diagnosed PPH two other times, and neither patients had good outcomes, Brenda said. The American Heart Association estimates 500 to 1,000 new cases of PPH are diagnosed each year of those. Brian and Brenda wasted no time in bundling their son off to New York, where he was immediately equipped with a portable pump and surgically inserted tube in his chest. Blood pressure in his lungs was more than eight times the normal pressure. A then-new Glaxo-Wellcome drug, approved in 1995, Flolan, was pumped into Jared 24 hours a day beginning March 5, 1997, and during the next two weeks, he improved. His parents learned how to mix the medicine so they could provide around-the-clock treatments at home. For the next six years, Jared and his parents flew to New York every six months for checkups, and Jared continued his Flolan treatments. In time, the five-pound pump and five-foot tube made crawling and walking difficult for Jared. Brenda made alterations with a leather strap to prevent the tube from pulling loose when he crawled beyond the five-foot span. When he began walking, she fashioned a backpack so he could wear the pump on his body. "My wife was a real trooper. She did the brunt of the work, cared for him medically. I take no credit for that," Brian said. Brian is a vice president at Heartland Bank in Newark and a 1985 Newark High School graduate. Today, Flolan is not a part of his treatment, but Jared continues to take eight other prescription drugs. His lung blood pressure is down to less than twice the norm. "That is awesome," Brenda said. "He is doing extremely well. Throughout this whole process, he has been a happy kid, never complaining. He always did his treatments with a big old smile on his face. Nobody even knew he was sick." Jared's treatments and the expenses involved in multiple trips to New York, lodging and meals while there have set the Frackers back several thousand dollars every year. Jared's health problems have changed the Frackers. "I've learned to appreciate life and deal with what God gives you," Brenda said. "We had to adapt. It's made me a much better person because of it. People take life so for granted. When it's almost taken away, you realize how every moment is important." "We became a family of faith through many trials," Brian said. "No question, Jared is a gift from God. It's a humbling experience. You learn to treasure the finer details and the little things in life more than you may have noticed before." Meghan, Jared's nine-year-old sister, has become a protector to her brother. He calls her Sis, but she functions as a second mother, Brian said. As for Jared, he's very active. He loves Meghan. He loves pizza, and playing basketball and football. His favorite pet is Buster, his dog. He says school bores him. He'd rather be at home with his mother, but he liked learning about a.m. and p.m. He already knew how to tell time. He isn't allowed to ride roller coasters because going quickly up and down alters the activity of the heart, but his relationship with Buster helps make up for that loss. "I love him, and I kiss him on the lips. He's slobbery," Jared said. For more information or to make a donation, contact the Pulmonary Hypertension Association at 850 Sligo Ave., Suite 800, Silver Spring, MD 20910.
Twelve charged with fraud in $400 million fen-phen settlement in rural Mississippi county known for eye-popping jury verdicts DENISE GRONES Associated Press
Sep. 01, 2004
JACKSON, Miss. - Two more Fayette residents who received portions of a $400 million settlement with the manufacturer of the diet drug fen-phen in 1999 have been arrested and charged with fraud for allegedly lying about taking the drug. Lizzie Hammett, 52, and Regina Green, 56, were the latest two among ten other Fayette residents who had appeared before U.S. Magistrate Judge James C. Sumner Tuesday on the same charges. "These people were seeking money for a drug they never took. They conspired with others who were more knowledgeable about the system. They were never entitled to any type of compensation," FBI agent Bob Garrity said Tuesday. The defendants are accused of submitting fake pharmacy documents showing they used the diet drug. They face up to five years in prison and a $250,000 fine if convicted of conspiracy to commit an offense against the United States. Dennis Joiner, with the U.S. Public Defender's Office, said a federal grand jury investigation has been done, which means other witnesses have probably been interviewed in secrecy. The group will appear before a grand jury next week and Joiner said he's not sure if any of the 12 will testify. "I always advise my clients not to testify," he said. Joiner asked Hammett and Green to make no comments to the media. He said he's not sure yet, if the group will be represented as a whole, have separate representation from the public defender's office or seek their own counsel. The arrests Tuesday and Wednesday came after a yearlong federal investigation into a rural corner of southwestern Mississippi where juries have been known to return multimillion-dollar verdicts, attracting lawyers who were eager to capitalize. The FBI said it wanted to learn how individuals became part of these lawsuits and how juries were picked from an area where many people are kin or acquaintances. The $400 million settlement with nearly 800 people nationwide came after one of those so-called "jackpot" verdicts. A Jefferson County jury had awarded $150 million to five people who claimed fen-phen gave them heart and lung problems. Drug maker American Home Products, which has since changed its name to Wyeth, quickly settled the case, offering to cap damages at $400 million for the five plaintiffs and claimants in about 800 other cases. All those arrested for alleged fraud are from Jefferson County. They were released Tuesday and Wednesday on their own recognizance. More arrests were expected, the FBI said. American Home Products made Pondimin, the fenfluramine half of fen-phen, and Redux, a chemical cousin. About 6 million people took the drugs before they were pulled from the market in 1997 amid evidence they caused heart-valve damage in some patients. Wyeth Pharmaceuticals spokesman Douglas Petkus said Wednesday that the company cooperated with authorities, but he would not discuss any details.
7-year-old overcomes rare condition
Local child fights primary pulmonary hypertension
By SUE SOWARDS
Advocate Correspondent Jared was born with primary pulmonary hypertension and was finally taken off his infusion pump last year. MADISON TOWNSHIP -- He has his father's lanky frame, his mother's large hazel eyes and the sweet cheerfulness of a happy 7-year-old. No one knows where Jared Fracker, of Madison Township, got his rare, usually disabling or fatal disease. It has a dauntingly cumbersome name, primary pulmonary hypertension, a progressive disease of unknown cause that results in the narrowing of the blood vessels in the lungs, causing high blood pressure and eventually leading to heart failure, according to the American Lung Association. Jared, a second-grader at Madison Elementary School, has so far beat the odds. In 2000, there were 3,065 deaths attributed to PPH, according to the ALA. Dramatically improved, he is now just as active as other children, and no one would guess he is sick, his parents, Brian and Brenda Fracker said. Brian, 38, and Brenda, 35, said the diagnosis of PPH was made when other illnesses, including secondary pulmonary hypertension, were excluded. Jared is unlike most PPH patients, who are young adult females. Normal at birth, a month later Jared became critically ill. He labored for each breath. Taken to Children's Hospital in Columbus, he was put on a ventilator. He had a virus, the doctors said. With medical treatment, he improved. But at three months, the symptoms returned. Struggling for each breath, "He would suck (briefly) on his bottle, then stop and breathe," his mother said recently. Reflecting upon their painful journey, they credit Dr. David Chan, pediatric cardiologist at Children's Hospital in Columbus, along with Dr. Robyn Barst of New York Presbyterian Pulmonary Hypertension Center, with Jared's recovery. When Dr. Chan diagnosed Jared, the Frackers were devastated and scared. "Dr. Chan said Jared was in bad shape" and he'd only diagnosed PPH two other times, and neither patients had good outcomes, Brenda said. The American Heart Association estimates 500 to 1,000 new cases of PPH are diagnosed each year of those. Brian and Brenda wasted no time in bundling their son off to New York, where he was immediately equipped with a portable pump and surgically inserted tube in his chest. Blood pressure in his lungs was more than eight times the normal pressure. A then-new Glaxo-Wellcome drug, approved in 1995, Flolan, was pumped into Jared 24 hours a day beginning March 5, 1997, and during the next two weeks, he improved. His parents learned how to mix the medicine so they could provide around-the-clock treatments at home. For the next six years, Jared and his parents flew to New York every six months for checkups, and Jared continued his Flolan treatments. In time, the five-pound pump and five-foot tube made crawling and walking difficult for Jared. Brenda made alterations with a leather strap to prevent the tube from pulling loose when he crawled beyond the five-foot span. When he began walking, she fashioned a backpack so he could wear the pump on his body. "My wife was a real trooper. She did the brunt of the work, cared for him medically. I take no credit for that," Brian said. Brian is a vice president at Heartland Bank in Newark and a 1985 Newark High School graduate. Today, Flolan is not a part of his treatment, but Jared continues to take eight other prescription drugs. His lung blood pressure is down to less than twice the norm. "That is awesome," Brenda said. "He is doing extremely well. Throughout this whole process, he has been a happy kid, never complaining. He always did his treatments with a big old smile on his face. Nobody even knew he was sick." Jared's treatments and the expenses involved in multiple trips to New York, lodging and meals while there have set the Frackers back several thousand dollars every year. Jared's health problems have changed the Frackers. "I've learned to appreciate life and deal with what God gives you," Brenda said. "We had to adapt. It's made me a much better person because of it. People take life so for granted. When it's almost taken away, you realize how every moment is important." "We became a family of faith through many trials," Brian said. "No question, Jared is a gift from God. It's a humbling experience. You learn to treasure the finer details and the little things in life more than you may have noticed before." Meghan, Jared's nine-year-old sister, has become a protector to her brother. He calls her Sis, but she functions as a second mother, Brian said. As for Jared, he's very active. He loves Meghan. He loves pizza, and playing basketball and football. His favorite pet is Buster, his dog. He says school bores him. He'd rather be at home with his mother, but he liked learning about a.m. and p.m. He already knew how to tell time. He isn't allowed to ride roller coasters because going quickly up and down alters the activity of the heart, but his relationship with Buster helps make up for that loss. "I love him, and I kiss him on the lips. He's slobbery," Jared said.
Fighting back For more information or to make a donation, contact the Pulmonary Hypertension Association at 850 Sligo Ave., Suite 800, Silver Spring, MD 20910.
Diet-drug lawsuits netting slim payoffs Plaintiffs from all over the country have come to Philadelphia to sue drugmaker Wyeth over claims of heart damage. By L. Stuart Ditzen
Inquirer Staff Writer
Not all visitors to Philadelphia this summer have come to see the Liberty Bell. From as far as Texas and Utah, some have come to spend their days in Common Pleas Court. These visitors are at the head of a long procession of people from all over the country - 12,700 in all - who have filed lawsuits here against the Madison, N.J., drug manufacturer Wyeth. All claim that the once-popular diet drugs Pondimin (an ingredient in the drug cocktail fen-phen) or Redux, made by Wyeth, caused them heart damage - though in many cases they are unable to document any serious injury. And all have opted out of a $3.75 billion diet-drug settlement in U.S. District Court that would have paid most of them $6,000 each and provided future medical benefits. They hope to win more money in state court. But so far, as the first diet-drug trials have unfolded in City Hall, Philadelphia juries have been less than generous. One jury two weeks ago awarded only $4,000 - total - to five women from Utah after a three-week trial. The lead lawyer in that case, Edward F. Blizzard of Houston, Texas, called the verdict insulting. "It's very disappointing," said Lenis Rogowski, one of the plaintiffs, who lives in Lehi, Utah. "We have no idea at all how they came to that verdict. From what I'm told, that's kind of a slap in the face. Giving that amount of money is worse than nothing." Four Philadelphia-area women in another trial, which ended Thursday, were given exactly that - nothing - by a jury. In two other trials, all plaintiffs have seen their claims denied except one - a Houston man awarded $48,000. Several more trials are under way. And as they unfold, Philadelphia has become the battleground of the moment in a sprawling legal war launched seven years ago by negligence lawyers who claim their clients were injured by Pondimin and Redux. The cases are here for two reasons. First, Wyeth's global pharmaceutical headquarters is in Collegeville; Madison, N.J., is the company's corporate headquarters. Second, Philadelphia Common Pleas Court is capable of handling the huge caseload. For 12 years, the court system has run a highly regarded "mass torts program" through which daunting numbers of claims in other big litigations - most notably, asbestos cases - have been resolved. Pondimin and Redux were withdrawn from the market in 1997 based on reports that some users had developed heart-valve damage. A small number of people also developed a fatal heart-lung disease called primary pulmonary hypertension. Although medical researchers predicted that only about 8,300 serious heart-valve cases would develop among six million diet-drug users, Wyeth was hit with more than 200,000 claims in federal and state courts. In court pleadings, the company contends that vast numbers of those claims are bogus. Plaintiffs' lawyers say the company badly underestimated how many people were injured. While disputing widespread injuries, the company has paid more than $13 billion in settlements and legal costs since 1997. It is holding $3.4 billion in reserve to meet further claims. But Wyeth officials say they are determined to fight the current round of claims in Philadelphia. For the most part, the cases going to trial here involve plaintiffs who have a condition commonly known as a heart murmur or "regurgitation" that occurs widely in the general population. The condition occurs when a valve in the heart fails to close properly, allowing a small amount of blood to backwash into one of the heart chambers after being pumped through. The heart must work harder than necessary because some blood must be pumped through the chamber twice. But unless the problem is severe, it usually does not interfere with a person's normal activities. The diet-drug plaintiffs contend that their heart murmurs were brought on by Pondimin and Redux and that, sometime in the future, their conditions might get worse and require surgery. But years after taking the drugs, most of the people who have filed the lawsuits have no disabling heart injuries and are leading normal lives. "They don't have treating doctors who will back up their stories," said Michael T. Scott, a lawyer for Wyeth. "The juries aren't buying it." "Many of the plaintiffs do not have a doctor," confirmed Wayne Spivey, a plaintiff's lawyer deeply involved in the diet-drug litigation. "And many of them do not have symptoms." More than 60 diet-drug trials, with plaintiffs from North Dakota, Oklahoma, Virginia, California, Idaho and elsewhere, have been scheduled for trial over the next year. Lee B. Balefsky, a Philadelphia lawyer involved in some of the cases, said it was too soon to draw broad conclusions from the initial verdicts. "I don't think you can say this is going to be a pattern," Balefsky said. "I think we have to have more trials and more verdicts to determine what these cases are worth." Common Pleas Court Judge William J. Manfredi, supervisor of the civil courts, said the trials would continue until benchmarks are established that place a range of values on the claims. Once those guidelines are established, Manfredi said, the remaining diet-drug cases should be resolved through mediation. Mary K. McGovern, manager of the mass torts program, said the diet-drug cases are moving on a tightly regulated time schedule and all should be resolved - by trial, settlement or dismissal - by 2007. Contact staff writer L. Stuart Ditzen at 215-854-2431 or sditzen@phillynews.com.
Enoximone Data to Be Presented at HFSA Annual Scientific Meeting
DENVER, Sept. 8 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG - News), a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today announced that Arthur M. Feldman, M.D., Ph.D., will present detailed results of EMOTE, the non-pivotal Phase III study of enoximone capsules in chronic heart failure ("CHF"), at the 8th Annual Scientific Meeting of the Heart Failure Society of America ("HFSA").
Myogen previously disclosed preliminary results of the study in March 2004. Dr. Feldman's abstract has been selected for presentation at the "Late Breaking Clinical Trials" session, Wednesday, September 15, 2004, at 8:30 a.m. (Eastern). Dr. Feldman is Magee Professor and Chair of the Department of Medicine at Jefferson Medical College of Thomas Jefferson University and the principal investigator for EMOTE.
The 8th Annual Scientific Meeting of the HFSA will be held Sunday, September 12, through Wednesday, September 15, 2004 at the Metro Toronto Convention Centre (North Building) in Toronto, Ontario, Canada. Additional conference information is available at http://www.hfsa.org/annual_meeting.asp. EMOTE is a non-pivotal Phase III trial of enoximone capsules in 201 patients in the most advanced stage of CHF who are dependent on intravenous (i.v.) inotrope therapy. The study was designed to evaluate the effectiveness of enoximone capsules to wean patients off of i.v. inotrope therapy. ESSENTIAL I & II, the Company's two pivotal Phase III trials of enoximone capsules in patients with CHF, completed enrollment of over 1,800 patients in May 2004. The trials will continue until there have been a total of 956 primary endpoint events (cardiovascular hospitalization or all-cause mortality). The Company expects that the specified number of events will have occurred by the end of this year. About Myogen Myogen is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. Myogen currently markets one product in Europe for the treatment of acute decompensated heart failure and has three product candidates in late-stage clinical development:
enoximone capsules for the treatment of chronic heart failure, ambrisentan for the treatment of pulmonary arterial hypertension and darusentan for the treatment of resistant systolic hypertension.
The Company, in collaboration with Novartis, also conducts a target and drug discovery research program focused on the development of disease-modifying drugs for the treatment of chronic heart failure and related cardiovascular disorders. Please visit our website at www.myogen.com. Safe Harbor Statement This press release contains forward-looking statements that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the "Risk Factors" section of Myogen's Annual Report on Form 10-K filed on March 1, 2004. Myogen is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. The Company cautions investors not to place undue reliance on the forward- looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. The Company's results may be affected by its effectiveness at managing its financial resources, its ability to successfully develop and market current and new products, difficulties or delays in its clinical trials, difficulties or delays in manufacturing its products, and regulatory developments involving current and future products. Delays in clinical trials, whether caused by adverse events, patient enrollment rates, regulatory issues or other factors, could adversely affect the Company's financial position and prospects. Results from earlier clinical trials are not necessarily predictive of future clinical results. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue one or more of its drug development or discovery research programs. Myogen is at an early stage of development and may not ever have any products that generate significant revenue
Federal Judge Preliminarily Approves New Diet Drug Settlement Amendment
Baron & Budd attorney Ellen Presby appointed to new committee overseeing new Fen Phen settlement amendment
The federal judge presiding over the American Home Products (AHP) Fen-Phen diet drug settlement preliminarily approved a new amendment to the settlement agreement.
DALLAS, TX (PRWEB) September 16, 2004 -- The federal judge presiding over the American Home Products (AHP) Fen-Phen diet drug settlement preliminarily approved a new amendment to the settlement agreement. The 7th Amendment modifies the national diet drug settlement between Wyeth and victims of the diet drug Fen-Phen. Wyeth manufactured the Pondimin component of Fen-Phen before the drug’s removal from the market in 1997, when a Mayo Clinic report linked the drug to serious heart and lung damage. Ellen Presby is appointed to 7th Amendment Liaison Committee. In granting preliminary approval of the amendment, Federal Judge Harvey Bartle III appointed Fen-Phen attorney Ellen Presby to the committee that will oversee the new Fen-Phen settlement amendment. If the 7th Amendment attains final judicial approval, Wyeth will pay $1.275 billion of additional funding to compensate Fen-Phen victims. Attorney Ellen Presby, along with other members of the newly created 7th Amendment Liaison Committee, will participate in administering the $1.275 billion infusion of new diet drug settlement money. The AHP Settlement Trust will not administer the new settlement money. Before the 7th Amendment, the AHP Settlement Trust was responsible for disbursing the diet drug settlement benefits paid by Wyeth. The AHP Settlement Trust was established in 2001, and has paid only a small fraction of the settlement benefits promised, leaving most Fen-Phen victims empty handed. The AHP Settlement Trust has been criticized for its failure to process and pay claims according to the terms and deadlines set in the original diet drug settlement agreement. Under the 7th Amendment, the new settlement money will not be received or processed by the AHP Settlement Trust. Rather, the $1.275 billion will be distributed by a new fund administrator who will work with the 7th Amendment Liaison Committee and Plaintiffs’ Class Counsel. Most Fen-Phen victims who have filed claims with the AHP Settlement Trust will have the option of participating in the 7th Amendment or continuing with the Trust. Qualifying participants in the 7th Amendment will receive guaranteed payments if they need heart valve surgery in the future. In addition to the new settlement money to be paid by Wyeth, the 7th Amendment provides other advantages to Fen-Phen victims. If individuals participating in the 7th Amendment need heart valve surgery in the future, Wyeth will pay benefits to those who qualify regardless of whether the AHP Settlement Trust has exhausted its funding. According to estimates, the AHP Settlement Trust will not have enough money to pay everyone who has filed a claim with the Trust. Without the 7th Amendment, Fen-Phen victims who need heart valve surgery will receive nothing from the AHP Settlement Trust once it runs out of money. AHP Settlement Trust claimants will receive notice packets.
Federal Judge Bartle also has ordered that those who have registered with the AHP Settlement Trust will receive a notice packet to explain the terms of the new diet drug settlement amendment. A hearing on the 7th Amendment’s fairness will be held in Federal Judge Bartle’s court at 9:30 a.m. on January 18, 2005. The diet drug MDL web site, http://fenphen.cpcourt.com/, posted Federal Judge Bartle’s orders and a copy of the 7th Amendment.
Drugmakers press FDA on diet pills By Rob Stein
The Washington Post
Published on: 09/19/04 WASHINGTON — Eyeing a potential gold mine in the global obesity epidemic, the pharmaceutical industry has launched a massive drive to develop new diet pills and an intense campaign to persuade the government to make it easier to get weight-loss drugs onto the market. Dozens of companies are testing scores of experimental compounds designed to curb appetite, block weight gain and burn fat. Although most are in the earliest stages, many have moved into preliminary tests in people, and a handful have progressed further. One is generating widespread excitement and could make it onto pharmacy shelves by the end of next year. "It's a hot field," said Donny Wong, an analyst at Decision Resources Inc., a Waltham, Mass., market research firm. "Every large pharmaceutical company has an obesity program, and if they don't have one, they are trying to get one." To encourage and prepare for the flood of drugs that could emerge, the Food and Drug Administration has initiated its first review in nearly a decade of how it assesses new obesity medications. The industry — joined by some obesity experts and advocates alarmed by the burgeoning health crisis — is pressing the agency to demand less stringent testing and to speed approval of new agents. "Our feeling is they have a different standard for weight-loss drugs than they do for other drugs for important health problems," said Jonathan Hauptman of the pharmaceutical maker Hoffmann-La Roche in Nutley, N.J. "We'd like them to be treated on a level playing field. We'd like people to start thinking about weight loss not as a cosmetic issue but as a medical benefit." The push is occurring as a growing number of scientists and doctors have become convinced that overcoming the body's imperative to stockpile fat will require an assortment of drugs, mixed and matched in various combinations, and that many patients will be taking these cocktails for years — perhaps for life — along with dieting and exercising. That could create a market akin to those for other major chronic illnesses. "It's commonplace to use multiple drugs for complex diseases," said Arthur Frank, an obesity expert at George Washington University. "Most people with AIDS take combination drugs. Most people with cancer take combinations of drugs. Most people with heart disease use a combination of drugs. That's probably what we'll have to get to with the management of obesity." But the intensifying pressure for new obesity drugs is raising fears among some consumer advocates who worry it could produce little more than the next round of marginally effective, unsafe diet pills. "These drugs have a 40- to 50-year history of clearly doing more harm than good," said Larry Sasich of the Public Citizen Health Research Group. "None of them have ever been shown that they can be taken safely for a long enough time to reduce deaths from chronic illness caused by obesity." The campaign for new weight-loss drugs is shadowed by a checkered history of bogus cure-alls and addictive amphetamines that were more salves for the vain than cures for the ill. More recent efforts to develop safe and effective drugs were marred by the discovery that the popular "fen-phen" drug combination caused life-threatening heart-valve problems. The FDA pulled it from the market in 1997. Since then, only two drugs have been approved in the United States for weight loss: Xenical and Meridia. Both can help people lose weight, but both have major shortcomings. That leaves the two-thirds of Americans who are overweight, including the one-third who are obese, with scant options beyond often ineffective or marginally effective diet and exercise programs and expensive, possibly risky stomach surgery. But scientists have been parsing the intricacies of how the body regulates appetite, stores fat and burns flab, leading to the discovery of dozens of hormones, brain signals and physiological mechanisms that offer a host of promising new targets for drugs. Eager to exploit the potential multibillion-dollar market being created by the vast and rapidly increasing number of overweight Americans, drug companies are racing to capitalize on these advances. By some estimates, 180 drugs are already being tested by more than 70 companies. The drug closest to pharmacy shelves, called rimonabant, blocks a pathway in the brain that produces the craving for food that occurs when people smoke marijuana. Studies so far, including findings released last month, have found that the drug enables people to safely lose significant amounts of weight, while cutting risks for heart disease and diabetes. It also helps people quit smoking, which has analysts predicting it could be a blockbuster drug. The company hopes to seek FDA approval next spring. Aside from rimonabant, which would be marketed as Accomplia, three other drugs have undergone fairly extensive testing. Regeneron Pharmaceuticals Inc.'s Axokine suppresses appetite. While it has not worked in as many people as the company initially hoped, Axokine may prove useful for selected patients. A small British biotech company, Alizyme PLC, is developing ATL-962, which blocks fat absorption. And Ortho-McNeil Pharmaceutical's epilepsy drug, Topamax, also helps many people shed weight. But most attention is focused on dozens of novel molecules further back in the pipeline. There are compounds that block a hormone called ghrelin, which the stomach sends to the brain to rev up an appetite, and agents that mimic another hormone, called PYY, that the gut uses to signal that chow time is over. There are drugs that could prevent a belly full of food from being converted into flab, and others that might act as a workout-in-a-pill by firing up the body's natural fat-burning systems. While many drugs are showing promise, experts say it remains unlikely a single potent agent will be found to cure obesity, given the multiple metabolic signals that humans have evolved to prevent starvation. "The body's system for storing fat is so strong that if you pull, it pushes back, and if you push, it pulls," said Kishore M. Gadde, a Duke University obesity researcher. "We block something here, and over the long haul the body will develop a mechanism to defeat what you're trying to do." Even if many of the experimental agents fall short of expectations, experts say many may still prove useful by at least preventing weight gain, squeezing out modest weight loss and fighting the tendency to regain hard-lost pounds. "There was this concept that if you lose weight with a drug and you stop the drug, you're going to stay there," said Eric Ravussin of the Pennington Biomedical Research Center in Baton Rouge, La. "That's not the case. It's like hypertension. If you take the pill, it stays down, but if you stop, it goes up high again. I think it's going to be the same with weight loss. You'll have to take them for life, because if you quit, it's going to go back up." Because the food-and-fat system is so closely entwined with other important metabolic functions, many compounds are likely to have multiple effects. Drug companies hope these multitasking agents will win approval for several conditions, giving them a bigger market. The FDA is under pressure to take these scenarios into consideration, particularly after Medicare's watershed decision in July to drop a long-standing policy that obesity is not a disease. The drug industry and obesity experts hope to extend that victory to drug treatments as new pills make their way to patients. The FDA is being pressed to consider blessing drugs based on shorter studies with less demanding criteria, even if they carry some risks. "I think they should be willing to tolerate more risks," said Richard L. Atkinson, the obesity association's president. "If a person has a disease, you have to balance the risks versus the benefits, as we do with all other diseases." A panel of experts the FDA convened last week recommended approving new obesity drugs based on only one year of safety data, instead of the two currently required. The agency wants to encourage obesity drug development while avoiding another fen-phen debacle. The FDA also knows that anything approved for the obese may end up in the hands of people who are only overweight. For them, the risk-benefit calculus is less clear. "We will take some time to review the discussions at the meeting and go to work to make any changes ... ultimately deemed appropriate to facilitate the development of obesity drugs for the U.S. market without sacrificing standards for safety and efficacy," said the FDA's David Orloff.
Merck turns to a nasal spray to help in weight reduction fight
BY ED SILVERMAN AND SUSAN TODD
Star-Ledger Staff
A little spritz in the nose may help you lose weight.
At least, that's what Merck is hoping. September 28, 2004
Yesterday, the world's fourth-largest drug maker licensed an unusual obesity medication that is still being developed -- a nasal spray that would discourage overeating by giving a patient a full feeling. Known in the lab as PYY, the spray is supposed to deliver an appetite-regulating hormone directly into the bloodstream. The hormone is produced by special endocrine cells in the gut after a person eats, and triggers a full feeling. For Merck, the deal with Nastech Pharmaceutical is the latest in a growing number of alliances the Whitehouse Station-based drug maker is striking with small biotechnology companies. Merck needs to bolster its pipeline, thanks to generic competition and setbacks in the lab. More significantly, the pact reflects an intensifying race for a new fat fighter. As many as 52 companies are believed to be conducting some level of research in the field, which suffered a resounding setback with the 1997 recall of two widely used diet pills. The market, nonetheless, remains large and lucrative. Approximately 60 million adults in the United States are considered obese, including 9 million who are severely obese, according to the American Obesity Association. The drug maker considered to be leading the race, Sanofi-Aventis, has said it expects peak sales of $3.7 billion for its own medicine -- Acomplia, which is still about two years from reaching pharmacies. "This is one of the most hotly pursued areas in the entire pharmaceutical and health-care industry," said George Yancopoulos, chief scientific officer of Regeneron Research Laboratories, a New York biotech developing an obesity drug. The market for diet pills soared in the mid-1990s with fen-phen, and the subsequent introduction of Redux, a chemical cousin of Pondimin, one of the fen-phen pills. Pondimin and Redux were recalled in 1997 after being linked to serious heart and lung damage. There are two older obesity drugs on the market -- Xenical, marketed by Hoffmann-La Roche, and Meridia, sold by Abbott Pharmaceuticals. Neither is a big seller, though, partly because only modest weight reduction is possible. As part of the latest deal, Merck will initially give $5 million to Nastech Pharmaceutical, which is based in Bothell, Wash. Another $340 million will be paid if various development milestones and sales targets are met. PYY is currently in the early stages of development. Merck will jointly develop the medicine, and will lead and fund all marketing activities. Nastech CEO Steven Quay said the medicine could reduce patients' daily calorie intake 30 percent, pending additional tests. That would results in a weight loss of about 50 pounds a year, based on the 2,800 calories a day the average American eats, he said.
Cystic Fibrosis Continuing Medical Education (CME) Program to Be Held at NACF
Special Session to Focus on Emerging Approaches in the Management of Lung Infections in Cystic Fibrosis ST. PAUL, Minn., Sept. 27 /PRNewswire/ -- The Postgraduate Institute for Medicine (PIM) is sponsoring a CME certified special session at this year's North American Cystic Fibrosis (NACF) conference in St. Louis on October 14, 2004. The program, which is supported by an educational grant from Corus Pharma, is entitled "Emerging Approaches in the Management of Lung Infections
in Cystic Fibrosis." The special session will be moderated by Dr. Peter Hiatt, Associate Professor of Pediatrics, Department of Pediatrics, Baylor College of Medicine, and will include presentations by Dr. Jane L. Burns,
Dr. Bruce Rubin and Dr. David Rodman.
According to the Cystic Fibrosis Foundation (CFF) there are approximately 30,000 Cystic Fibrosis (CF) patients in the United States and 33,000 CF patients throughout the rest of the world. Despite improvements in therapies and enhanced understanding of the disease, there is still no cure for CF and according to the CFF, the current median life expectancy of a CF patient is 33.4 years, with more than 90% of CF patients ultimately dying from lung
destruction resulting from the inflammatory response to chronic lung infections. The special session will provide an opportunity to discuss current CF treatment strategies and examine new data that may shape healthcare choices
made by CF patients. Emerging Approaches in the Management of Lung Infections in Cystic Fibrosis
CME Accredited Special Session
Thursday, October 14, 2004
7:00 - 9:30 PM
Renaissance Grand Hotel, Majestic D Room
St. Louis, Missouri 7:00 pm - 7:30 pm Registration and Reception
Majestic foyer 7:45 pm - 7:50 pm Welcome and Introductions
Chair: Peter Hiatt, MD
Majestic D 7:50 pm - 8:15 pm Effective Long-Term Management of Chronic Respiratory Infections in the Cystic Fibrosis Patient: Current Options and Unmet Needs
Jane L. Burns, MD 8:15 pm - 8:40 pm Patient Compliance and Improved Quality of Life:
Barriers and Opportunities for Enhancement
Bruce Rubin, MD 8:40 pm - 9:05 pm The Continuum of Care: Special Treatment Challenges in the Adult CF Patient
David Rodman, MD 9:05 pm - 9:20 pm Panel Discussion/Question and Answer
Chair as Moderator 9:20 pm - 9:30 pm CME Program Evaluation and Closing Remarks
Chair About Dr. Peter Hiatt
Dr. Peter Hiatt is an Associate Professor of Pediatrics at Baylor College
of Medicine. He is a member of the Pediatric Pulmonology Subboard and Credentials committees for the American Board of Pediatrics; the Planning committee for American Thoracic Society, pediatric Assembly. He's a past
committee member of the Cystic Fibrosis Center, and Steering and Protocol Development committees for the Therapeutic Development Network for the Cystic
Fibrosis Foundation. Dr. Hiatt has published several articles on Cystic Fibrosis and other respiratory diseases. About Dr. Jane L. Burns
Jane L. Burns, MD, is a Professor of Pediatrics at the University of Washington in Seattle, Washington. She is also Director of the Cystic Fibrosis Microbiology Laboratory and the Infectious Disease Clinic at Children's Hospital and Regional Medical Center, also in Seattle. Dr. Burns
earned her medical degree from the University of Washington. She completed her residency at Children's Hospital and Medical Center, where she also served
as Chief Pediatric Resident. She received fellowship training in Pediatric Infectious Diseases at the University of Washington. About Dr. Bruce Rubin
Dr. Rubin is a Professor and Vice Chair in the Department of Pediatrics, Professor of Physiology and Pharmacology at the Wake Forest University School of Medicine in Winston-Salem, North Carolina and Professor of Biomedical
Engineering at Virginia Tech. Dr. Rubin earned his BSc, Master of Engineering and MD degrees at Tulane University in New Orleans, LA and was a Rhodes Scholar at Oxford University where he worked on his post doctoral work in
biomedical engineering. Dr. Rubin is on the Editorial Board of eight pulmonary journals including The Journal of Aerosol Medicine, Current Respiratory Medicine Reviews, The Journal of COPD, Pediatric Pulmonology, and the Journal of Pediatric Respiratory Disease. He is Section Editor for Basic
Research for the journal Chest, as well as Associate Editor of the journals Clinical Pulmonary Medicine, Paediatric Respiratory Reviews, and The Canadian Respiratory Journal. About Dr. David Rodman
Dr. David M. Rodman, MD is a Professor of Pulmonary/Critical Care Medicine, Director, Adult Cystic Fibrosis Center, University of Colorado Health Sciences Center. Dr. Rodman's area of focus is on genetic lung
disease, with an emphasis on three diseases: primary pulmonary hypertension (PPH), lymphangioleiomyomatosis (LAM), and cystic fibrosis (CF). His Cystic Fibrosis research involves both basic and translational approaches, focused on host-pathogen interactions and control of airway epithelial cell gene expression by P. aeruginosa. About Cystic Fibrosis Foundation
Established in 1955, the mission of the Cystic Fibrosis Foundation is to assure the development of the means to cure and control cystic fibrosis (CF) and to improve the quality of life for those with the disease. Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Postgraduate
Institute for Medicine and Pro ED COMMUNICATIONS, INC. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians. Credit Designation
The Postgraduate Institute for Medicine designates this educational activity for a maximum of 2 category 1 credits toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she
actually spent in the activity.
SOURCE Corus Pharma | 
