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Fen Phen and Primary Arterial Hypertension News for August
Inflated diet ads By Jen Waters
THE WASHINGTON TIMES "Buyer beware" is the message consumers should remember when purchasing dietary supplements for weight loss, says Judith S. Stern, vice president of the American Obesity Association in Northwest. "I am optimistic for development of new drugs for basic causes of obesity, but right now on the over-the-counter market... there are exaggerated claims," she says. "They usually have testimonials that aren't true." Diet products, either prescription or dietary supplements, always seem to be at the center of controversy. Doctors continue to debate whether the products are effective at achieving weight loss and how dangerous the side effects might be.
This month, the Cleveland Clinic Journal of Medicine published a study saying "evidence is weak that any of the commonly used alternative products is effective for reducing weight in moderately overweight individuals." Right now, the only prescription drugs approved by the Food and Drug Administration for the long-term treatment of obesity include sibutramine, also known as Meridia; and orlistat, also known as Xenical. For short-term treatment of obesity lasting a few weeks, the government organization also approved phentermine, also known as Adipex; and diethylpropion, also known as Tenuate. Anyone trying to lose weight should be under the care of a physician, says Dr. Ramin Oskoui, clinical cardiologist at Washington Hospital Center. He says people should not take dietary supplements for weight loss without the advice of a doctor, especially because other medications could react poorly with the diet product. In fact, Dr. Oskoui says gastric bypass surgery for weight problems has become far more safe and effective than taking diet products. "Sustained weight loss is best achieved with a combination of diet and exercise," he says. "When you weigh 350 pounds, and you should weigh 175 pounds, there is no pill that will get you there, but there are a number of pills that will get you in trouble. ... People have paid a price for trying to lose weight this way." In 1997, the FDA removed the prescription drugs fenfluramine and dexfenfluramine from the market. However, it did not withdraw phentermine, the third-most commonly used obesity drug.
Of the patients evaluated for taking fenfluramine and dexfenfluramine, about 30 percent of them had abnormal echocardiograms. The organization stated that "these new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA's two earlier warnings concerning 'fen-phen,' a combination of fenfluramine and phentermine." When fen-phen first came out, it looked like it was a good drug, but some people developed heart valve abnormalities, without presenting obvious symptoms, says Dr. Rick Morrissey, chief of cardiology at Georgetown University Hospital. "If you took fen-phen, and you haven't been evaluated, you should see your primary care doctor or cardiologist," he says. "The FDA tries to do the best they can on medications, but we find out more about it once it's released to the general population." Further, in April, the federal government banned dietary supplements containing ephedra. In June, a jury awarded $7.4 million to Rhea McAllister, who suffered a stroke after consuming the stimulant in a Metabolife supplement. Margaret Peet, senior vice president of sales at GNC in Pittsburgh, says the company, which is the largest U.S. vitamin and dietary supplement chain, does not make claims about third-party products on their shelves. GNC has its own line of products, in which the company is completely confident. "We have them available for consumers if they would like to buy them," she says. "Choice is everything in the world, isn't it?"
However, Ms. Peet says products developed by GNC have undergone clinical trials. One such product is Total Lean Control, which contains a combination of guarana seed extract, black tea, grape skin extract, ginger and other herbs. "That's been clinically proven to reduce calorie consumption of food intake," she says. "Our products have undergone 150 quality checks before they arrive on the shelves. They are very safe." NSF International in Ann Arbor, Mich., evaluates the GNC products, Ms. Peet says. With the passage of the Dietary Supplement Health and Education Act of 1994, dietary supplement manufacturers are responsible for determining the safety of the products before they are sold. The FDA is responsible for taking action against any unsafe dietary supplements after they reach the market. The organization works closely with the Federal Trade Commission to evaluate advertising and labeling. Through the Freedom of Information Act, persons can request to find out what adverse events have happened in relation to dietary supplements. People can report complaints to their local FDA office, according to FDA officials. It's particularly disturbing that people with eating disorders, such as anorexia or bulimia, have such easy availability to diet products, says Dr. Graham Redgrave, an eating disorders attending physician at Johns Hopkins Medical Institutions in Baltimore. "For these patients, becoming thin is part of an illness," he says. "The pills are reinforcing the illness rather than helping them become more healthy." Further, Dr. Redgrave says he also worries about young people who are overweight who seek to change their bodies by means of the dietary supplements. "They are really putting themselves at risk for developing problem eating behaviors, like binge eating or other full-blown eating disorders," Dr. Redgrave says. "Young people who diet usually gain weight over time. Rather than going on crash diets and using supplements to help, it's much better to change one's lifestyle and the way one eats and exercises." However, 64.5 percent of the population in the United States is overweight, according to the American Obesity Association.
Some of those people can't lose the pounds through conservative means and prescription diets pills under the supervision of a doctor may be a good idea, says Dr. Arthur Frank, medical director of George Washington University Weight Management Program in Northwest. "You can 'out-eat' anything I can give you, but [prescription pills] can be helpful if a person is struggling and needs a little bit of help," Dr. Frank says. "There's some risk involved in doing nothing. Then, it leaves your obesity in place."
08/26/04
Judge gives preliminary OK for Fen-Phen (WYE) By August Cole
SAN FRANCISCO (CBS.MW) -- A federal judge has given preliminary approval to a change in Wyeth's (WYE) Fen-Phen settlement that could create a $1.275 billion fund for plaintiffs who chose a reduced payment, attorneys for the plaintiffs said. That would leave $3.75 billion for future use to treat people who have been harmed by the diet drug. The attorneys, who are sending the amendment to 40,000 plaintiffs, contend the original fund is "going bust." Wyeth shares rose 19 cents to $36.87.
Federal Judge Grants Preliminary Court Approval of New Fen-Phen Trust Solution
7th Amendment Goes Before 40,000 Fen-Phen Victims for Review PHILADELPHIA, Aug. 26 /PRNewswire/ -- The following was released today by Majority Counsel:
Attorneys who represent Fen-Phen victims today announced that Federal Judge Harvey Bartle III has granted preliminary approval to the 7th Amendment, a modification of the National Settlement between Wyeth and victims of Fen- Phen. A detailed explanation of the 7th Amendment will now be sent immediately to all Fen-Phen victims eligible to enter the new Claims Facility, who will have the chance to review, object or opt out of the amendment before it is granted final approval and enacted. If granted final approval by Judge Bartle, the 7th Amendment will create a $1.275 billion fund for Class Members who opt to receive the reduced settlements, leaving what remains of the original $3.75 billion Trust to help victims with ongoing health problems in years to come. "The original Fen-Phen Trust is going bust. This approval is a sign of real progress for thousands of victims who have been locked in a bureaucratic nightmare with no way to receive the help they deserve for their heart and lung damage," said Jerry Alexander, a victim representative and member of the 7th Amendment Liaison Committee. If the 7th Amendment receives Court approval, Wyeth will pay reduced settlements to more than 40,000 Fen-Phen victims with non-surgical conditions, while preserving funds in the original Trust. This guarantees future funds, as needed, for those claimants who participate in the 7th Amendment and ultimately have health problems that progress to heart valve surgery or other serious complications. This agreement, one year in the making, is designed to resolve more than 90% of the pending matrix-level claims currently filed with the Wyeth Fen-Phen Trust. "Thousands and thousands of Fen-Phen victims have waited months, even years for the help they were promised from Wyeth. The 7th Amendment is a real compromise -- a chance for these people to settle claims with the confidence that there will be funds available should their health decline," said Wayne Spivey, Chairman of the 7th Amendment Liaison Committee. "We are a long way from fixing the Fen-Phen Trust; but this preliminary approval is a start towards healing this broken system, and the many lives that have been trapped in its bureaucratic web," continued Spivey. The stay on Trust claims processing, enacted in May 2004, will continue during the victim review process, a period of 60 days. Wyeth also retains "walkaway rights" from the settlement if a substantial number of victims decline to participate. The Fen-Phen Trust was established in 2001 after the Mayo Clinic reported that Pondimin, a drug sold by Wyeth as half of the Fen-Phen combination, caused serious heart and lung damage. Since its creation, only a small fraction of Fen-Phen victims have received the help they were promised. According to Ellen Presby, a member of the 7th Amendment Liaison Committee who represents hundreds of claimants who have filed individual lawsuits, "This amendment provides a great opportunity to fairly resolve the claims filed within the National Settlement. The time has now come for Wyeth to turn its attention to the individual lawsuits filed against the company."
Fen-phen settlement is revised
New method proposed to expedite damage awards to users hurt by diet drug Aug 27, 2004 PHILADELPHIA A judge yesterday tentatively approved a revised settlement that will change the way Wyeth compensates people who suffered heart-valve damage after taking the fen-phen diet-drug combination. Attorneys for the company and former users of its Pondimin and Redux pills said they hope the new deal will streamline the process used to determine who was harmed enough by the drugs to deserve a share of the multibillion-dollar settlement. Wyeth, a major Richmond-area employer, made Pondimin, the fenfluramine half of fen-phen, and Redux, a chemical cousin. The "phen" part of the name is for phentermine. Pondimin was made only in Richmond. The agreement would set up a $1.275 billion fund for about 40,000 people who suffered nonlife-threatening valve damage from taking the drugs. Those people would get their money faster than under the initial settlement, approved in 1999, but could receive significantly less cash.
The changes were made after complaints about the claims-review process and worry that so many claims had been filed that the original $3.75 billion settlement fund could be exhausted before everyone was paid. U.S. District Judge Harvey Bartle III gave his consent to the amended deal yesterday. The proposal will now go back to the thousands of people who took the drugs, who will have the option of participating in it or rejecting it and pursuing individual lawsuits against the company.
As part of the deal, Wyeth could back out of the amended plan if too few people accept it. The company took fen-phen off the market in 1997 after researchers linked it to heart damage and a fatal lung disease. Fen-phen was never an FDA-approved combination. The phentermine half is still sold.
Judge approves revision to diet drug settlement DAVID B. CARUSO PHILADELPHIA - A judge on Thursday tentatively approved a revised legal settlement that will change the way the drugmaker Wyeth compensates thousands of people who suffered heart valve damage after taking the fen-phen diet drug combination. Attorneys for the company and former users of its Pondimin and Redux pills said they hope the new deal, worked out earlier this month, will streamline the complicated and problem-wracked process used to determine who was harmed enough by the drugs to deserve a share of the multibillion-dollar settlement. The agreement would set up a new $1.275 billion fund for about 40,000 people who suffered non-life-threatening valve damage from taking the drugs. Those people would get their money faster than under the initial settlement, approved in 1999, but could also receive significantly less cash. The changes were made because of complaints about the claims review process, and concerns that so many people had filed claims that it could exhaust the original $3.75 billion settlement fund before every person was compensated. U.S. District Judge Harvey Bartle III gave his consent to the amended deal Thursday. The proposal will now go back to the thousands of people who took the drugs, who will have the option of either participating in it, or rejecting it and pursuing individual lawsuits against the company. As part of the deal, Wyeth would have the option to back out of the amended plan if too few people decide to accept it. Wyeth pulled Pondimin and Redux, the fenfluramine half of fen-phen, from the market in September 1997 amid reports some users had heart valve damage and a few had a deadly lung condition. Fen-phen was never an FDA-approved combination, and the phentermine half is still sold.
Sales up, profits down at Bachem
APIs prop up Bachem in 2003
All news : August 2004
17/08/2004 - Fine chemicals maker Bachem has reported higher sales in the first half of the year, but profits were slightly weaker as unfavourable exchange rates took their toll. First half net profits were SF 16.9 milion, down from SF 17.7 million a year ago, while operating profit fell 3 per cent to SF 22.3 million. Sales grew 6 per cent to SF 75.5 million, which Bachem attributed to positive developments in its US business and more orders coming for peptide generics. Bachem’s research chemicals unit also reported an improvement in demand, with sales rising 5.6 per cent in local currencies, the first increase in 18 months. Active ingredients posted a sales growth of 8.1 per cent year-on-year, with peptide generics leading the charge. Growth opportunities for non-peptide generics, on the other hand, were limited by bottlenecks in production at Bachem's Sochinaz plant. A new facility is being built that should improve matters, and this could be on-line as soon as early-2005, said Bachem. For the full year, the company expects an increase in sales of between 2 and 5 per cent in local currencies. Mondobiotech deal Meanwhile, there was good news for Bachem just ahead of its results when it signed an agreement to produce and supply mondoBIOTECH of Italy’s lead compound Aviptadil. mondoBIOTECH is entering the product into a Phase II clinical trial to treat pulmonary arterial hypertension and plans to bring Aviptadil to the market in 2007. The product – based on vasoactive intestinal peptide - belongs to the glucagon-growth-hormone-releasing factor secretin superfamily and influences many aspects of pulmonary biology. It consists of 28 amino acids and is synthetically produced. At present, Aviptadil as an inhalation treatment is in Phase II clinical trials in patients with primary pulmonary hypertension. mondoBIOTECH has been granted orphan drug designation for Aviptadil for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension by the European Medicines Evaluation Agency. Bachem will supply mondoBIOTECH with current Good Manufacturing Practice (GMP)-standard Aviptadil for clinical trials and will assume the entire process validation including necessary documentation for the registration process.
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 Posted on Mon, Aug. 16, 2004
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.
Fen-Phen Trust Solution Filed, Off to Judge for Approval
A Year of Negotiations Ends With a New Agreement That Could Help More Than 40,000 Diet-Drug Victims PHILADELPHIA, Aug. 11 /PRNewswire/ -- The following was released today by Majority Counsel: Attorneys who represent Fen-Phen victims today announced that an amendment to the Fen-Phen Trust, labeled the 7th Amendment, has been approved by both sides and is filed before US District Judge Harvey Bartle III in Philadelphia.
The 7th Amendment will allow Wyeth to pay reduced settlements to more than 40,000 Fen-Phen victims. The 7th Amendment creates a $1.275 billion fund for a new class of Trust members who opt to receive reduced settlements upon final Court approval of the Amendment, leaving what remains of the original $3.75 billion Trust to help the victims who have ongoing health problems in years to come.
"The 7th Amendment is a real and meaningful solution to the Fen-Phen Trust where payments are essentially nonexistent for the vast majority of claimants. This solution preserves funding in the event claimants injured by diet drugs progress to heart valve surgery or similarly serious conditions and allows Wyeth to pay reduced settlements to more than 40,000 Fen-Phen victims with
non-surgical conditions," said Jerry Alexander, a victim representative and member of the 7th Amendment Liaison Committee.
Representatives from Wyeth and the 7th Amendment Liaison Committee have been working with Michael Fishbein, one of the attorneys representing the victim class action, for more than one year on this agreement which is designed to resolve up to 90% of the pending matrix-level claims currently filed with the Wyeth Fen-Phen Trust.
"Thousands and thousands of Fen-Phen victims have been locked in a system where they can't get the help they were promised. Now, some of those victims have a way out -- a choice to settle immediately and know that there will be funds available if their health declines," said Wayne Spivey, Chairman of the 7th Amendment Liaison Committee. "If this passes, it's a start. Unfortunately this isn't a cure-all for everyone and we still have a long way to go toward curing the problems of the Wyeth Fen-Phen Trust."
This agreement now requires judicial approval, and the stay on Trust claims processing will continue during this process.
The Fen-Phen Trust was established in 2001 after the Mayo Clinic reported that Pondimin, a drug sold by Wyeth as half of the Fen-Phen combination, caused serious heart and lung damage. It was later reported that another Fen-Phen ingredient produced by Wyeth, Redux, caused the same type of damage. Since its creation, more than 90,000 cases have been filed with the
$3.75 billion Trust, and as of January 2004 fewer than 3,000 of these cases were settled. Majority Counsel is a coalition of more than 45 firms and 150 attorneys representing the rights of over 45,000 victims who have been damaged by Fen-Phen. For more information about Majority Counsel, please visit: http://www.majoritycounsel.com .
Plan would speed fen-phen claims A proposed settlement with drugmaker Wyeth would expedite payments for former fen-phen users but would also drastically reduce the money they would receive. BY LINDA A. JOHNSON TRENTON, N.J.Thu, Aug. 12, 2004 - More than 40,000 former fen-phen users who claim the diet drugs caused minor heart-valve damage would be compensated faster -- but get significantly less money -- under a proposed deal to speed review of less-serious cases in the protracted litigation. The agreement, between drugmaker Wyeth and lawyers representing more than 100,000 former users of its Pondimin and Redux pills, would set up a new $1.275 billion fund, Madison-based Wyeth told The Associated Press on Wednesday. That fund would cover payments for about 40,170 people with non-life-threatening valve damage, the biggest group of claimants. Michael Fishbein, lead counsel for the plaintiffs, said if the agreement wins court approval quickly, payments to those people could be processed next year. ''It's a straightforward review process without a lot of delays,'' he said, unlike the complex reviews of current and past medical records for patients who chose to participate in the $3.75 billion national settlement Wyeth reached in 1999. Under the proposal, independent heart specialists would evaluate a claimant's echocardiogram, or heart ultrasound. Each claimant would be guaranteed at least $2,000. Those with documented heart-valve damage would receive more. ''They will receive payment for some share of that $1.275 billion amount and they will also be guaranteed that if their condition worsened'' by the end of 2011, they will receive additional benefits, Wyeth attorney William Ruane told The Associated Press. Plaintiffs attorney in Houston, who helped hammer out the agreement, said the average plaintiff -- a woman aged 50 to 54 when she took the pills -- would get about $68,000 from the new fund. Under the existing settlement, she could have received as much as $473,000. ''My clients think that's a huge difference,'' said the attorney, who represents about 1,000 people.
Moving on, giving back
This New Holland teen has overcome a battery of challenges since his much-publicized heart-lung transplant in 1999. On his 18th birthday, he talks about the next challenge: becoming a nurse and helping others. By Jane Holahan
Lancaster New Era Aug 31, 2004
LANCASTER COUNTY, PA - In 1999, Kenny Patterson Jr. had a heart and lung transplant at Children’s Hospital at the University of Pittsburgh. The 12-year-old New Holland boy was dying from primary pulmonary hypertension, a rare disease that causes dangerously high blood pressure in the blood vessels and damages both the heart and lungs, eventually destroying them both. While he was battling for his life, Patterson, who turns 18 today, also found a career. With all the extended stays in hospitals both before and after his transplant, Patterson decided he wanted to become a nurse. And this past weekend the Garden Spot graduate headed off to the University of Pittsburgh’s Titusville campus, to begin nursing school. “From all the experience I had in the hospital being sick, I realized I wanted to help people out,’’ Patterson says. “This is something I really want to do. I’m really focused.’’ “We just never thought we’d be at this point,’’ says his mother, Cheri. “We have been through so much and we appreciate everyone’s prayers and support for Kenny.’’ The communities of New Holland and East Earl poured out their hearts and wallets to the Patterson family five years ago as they went through the long period of waiting and recovery surrounding the transplant. Benefit auctions, dances, bake sales and concerts were held. Co-workers of both Mr. and Mrs. Patterson donated vacation days so they could spend time in Pittsburgh with their son. And Patterson has given back. As a junior at Garden Spot High School in 2003, he and a fellow student won honors for raising the most money for a dance-a-thon that benefited the Four Diamonds Fund. Now, as he enters nursing school, Patterson wants to keep helping. “Kenny is good with people and he’s very caring,’’ says his mother. “He knows what he went through and he can carry that over.’’ Patterson is hoping to become a nurse anesthetist. “After I’m an RN, I have to work in a critical care unit. I’ll probably work in an E.R. for two years. Then I’ll go back for my masters and become a CRNA — a certified registered nurse anesthetist. Anesthesia helped me through a lot,’’ he says. Patterson has spent a lot of time in hospitals. Before the transplant, he spent four and a half months in a hospital bed, unable to walk. He was so sick and weak his parents worried that a sneeze could hurt him. After the transplant in January 1999, he stayed in the hospital for two more months and had to deal with rejection problems that he says persisted for about a year and a half. “It’s called chronic rejection and they felt I might never get rid of it,’’ Patterson says. “But I’m feeling good. I had some tests done in July and they said this is the best they have ever seen me.’’ But his health is still fragile. Just last February, Patterson ended up being flown to the University of Pittsburgh after getting a cold which quickly turned into pneumonia. “They have to knock your immune system down to get your body to accept the transplant,’’ explains his mother. “He has no immune system, so things can turn really fast.’’ Patterson takes eight pills and one liquid medication twice a day to fight off the rejection and bolster his immune system so he won’t get sick. “The thing I am worried about, now that he’s on his own, is that he makes sure he takes his medication and keeps on top of how he’s feeling,’’ Mrs. Patterson says. “A lot of times, he’ll think he’s OK until he gets sick.’’ Patterson has been able to lead a relatively normal life since his rejection problems cleared up. He roller blades and swims and plays ice hockey. Like every college-bound kid, he’s excited about being on his own and insists he’ll be fine. And like every mom sending her child out the door, Mrs. Patterson has mixed emotions. “As a mom, I’m both excited and scared,” she says. “Now he’s his own man and he does his own thing. I tried to talk him into going to HACC (Harrisburg Area Community College) and commuting but he said no, he wanted to get out there and he’s excited. I think it’s just a little harder with everything we went through together.’’ The drive to Titusville is about five and a half hours. Patterson plans to move to the main Pittsburgh campus next year. “I had the grades to go this year, but there weren’t any dorm rooms available,’’ he says. While he is excited about his move, Patterson, an only child, knows it’s tough for his parents. “I know they are sad,’’ he says. “I owe a lot to my family and friends. They were always there to pick me up.’’ “I am very proud of him,’’ says Mrs. Patterson. “I just wish he was a little closer to home.’’
Ten charged with fraud in fen-phen case in Jefferson County Associated Press FAYETTE, Miss. - Ten people were arrested in Fayette on charges related to the $150 million verdict in 1999 in Jefferson County against the manufacturer of the diet drug fen-phen, FBI special agent Bob Garrity said Tuesday. Garrity said in a statement that the arrests came after an 18-month investigation that began in November 2002 into large jury awards. The FBI started the investigation to learn how individuals became part of these lawsuits and, perhaps, how juries were picked from an area where many people are kin or acquaintances. Much of the attention focused on Jefferson County - a poor black county of less than 10,000 residents - where a jury in 1999 awarded $150 million to five Mississippians who claimed the diet drug fen-phen gave them heart and lung problems. The case was eventually settled with more than 800 other fen-phen cases for a reported $400 million. The settlement details were sealed by the court. There was no immediate information on whether the 10 people charged Tuesday were plaintiffs in that case. Initial court appearances were pending. Garrity said the 10 were charged with conspiring to commit an offense against the United States - to defraud American Home Products, the maker of fen-phen. Garrity said that the charges were related to activities involving the Jefferson County case, in which the plaintiffs alleged they suffered damages from having taken fen-phen. Other information about the arrests was not immediately available. Those arrested were identified as Robert A. Buie, 41; Cora B. Durrell, 61; Ethel G. Fountain, 43; John A. Frye, 60; Regina R. Green, 51; Eva. M. Johnson, 55; Sabrena L. Johnson, 32; Evelyn Malone, 47; Lillie M. Walker, 63; and Yvonne N. Wright, 61. American Home Products, which has since changed its name to Wyeth, 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. Phentermine, the other drug in the combination, was not implicated in the problems.
Weight-Loss Franchises Pursue Fat Profits
August 05, 2004
By Julie Bennett Looking for a can't-lose business concept? Several franchise systems are cashing in on Americans' battle with their weight. Sometimes franchising seems to have two faces--and both come with double chins. On one side we have thousands of fast--and not so fast--food restaurants enticing people to devour frightening quantities of calories. On the other side are a dozen or so franchise systems trying to help consumers lose the pounds they just gained. According to the June 16, 2003, issue of U.S. News & World Report magazine, Americans are now spending about $40 billion a year on weight-loss products, programs and diet aids. One billion dollars of that money goes straight to Weight Watchers International, the Woodbury, N.Y., company that started as a franchise years ago and now is a publicly traded behemoth, with 44,000 weekly meetings in 30 countries. But it's too late to run one, because Weight Watchers stopped selling franchises and is buying up the 26% of U.S. locations that are still owned by franchisees. It isn't too late, however, to own a franchise that helps chubby consumers attempt to lose weight by eating healthy meals, exercising, chewing "fat burning" gum, or even being hypnotized. But the history of weight-loss franchises is, to say the least, spotty. Jenny Craig, in La Jolla, Calif., was the market leader in the early 1990s, then shed profits and lost scores of franchisees after getting involved with the fen-phen scandal and hiring Monica Lewinsky as a spokesperson (the middle-aged customers were appalled). And the Diet Center and Physicians Weight Loss Centers of America, both owned by the Health Management Group in Akron, Ohio, have all the stability of a yo-yo dieter. One hundred and sixty franchisees have left the Diet Center since 1999, and Physicians Weight Loss stopped prescribing appetite-suppressant drugs in March, according to director of franchise development Krishna McCollins, 31. However, it still promotes them on its Web site.
NEW PULMONARY HYPERTENSION GUIDELINE CHALLENGES USE OF COMMON MEDICATION
Genetic Testing Recommended in Patients With Family History of Pulmonary Hypertension
(NORTHBROOK, IL, July 12, 2004) – A new evidence-based guideline for pulmonary arterial hypertension (PAH) cautions the use of calcium channel blockers, a commonly used treatment for high blood pressure, in unstable patients due to the potentially fatal side effects associated with the medication. PAH is a life-threatening condition that occurs when the arteries that supply blood to the lungs become constricted, limiting the blood flow to the lungs and, ultimately, causing high blood pressure to develop within the lung arteries. The American College of Chest Physicians (ACCP) Diagnosis and Management of Pulmonary Arterial Hypertension: ACCP Evidence-Based Clinical Practice Guideline provides recommendations for diagnosing and treating PAH. Published in the July issue of CHEST , the peer-reviewed journal of the ACCP, the guideline was developed by a multidisciplinary panel of experts from five medical specialties and is endorsed by the American College of Cardiology Foundation, American College of Rheumatology, American Heart Association, and the Pulmonary Hypertension Association.
Panel members recommend against the empiric use of calcium channel blockers or their use in patients who do not respond to acute pulmonary vasodilator testing, citing an increased risk of adverse and potentially fatal events related to the use of the medication. Due to the severity of the disease, the panel also advises genetic testing for patients with a family history of PAH and advance screening for patients with certain chronic diseases who are predisposed to PAH. “Calcium channel blockers are regularly used to treat high blood pressure because they limit calcium entry into the cells and dilate the constricted systemic blood vessels, thereby lowering blood pressure. This rationale is frequently applied to their use in PAH; however, when they are used in patients with PAH whose narrowed pulmonary arteries are not caused by dynamic vessel constriction, the side effects can be fatal,” said Panel Chair Lewis J. Rubin, MD, FCCP, University of California San Diego School of Medicine, La Jolla, CA. “When left untreated, PAH can cause serious health problems, such as difficulty breathing, blood clots, and fluid retention due to right-sided heart failure. Moreover, patients in specific populations, such as women who are pregnant and patients with respiratory disease, are at greater risk of developing severe complications as a result of PAH. Genetic testing can help to identify patients who are most at risk for developing PAH, allowing clinicians to closely monitor patients and begin treatment at the first sign of the disease.” The evidence-based guideline is based on a structured review of all available guidelines and published research related to PAH. The guideline provides specific recommendations for screening, early detection and diagnosis, medical therapies, surgical interventions, sleep-disordered breathing, and prognosis of PAH. Recommendations were graded in regard to the quality of evidence available or expert opinion and the benefit of the diagnostic or therapeutic procedure for the patient population.
Aside from genetic testing, the guideline recommends that patients with unexplained PAH undergo testing for connective tissue disease and HIV infection, conditions that may predispose patients to PAH. Patients who are evaluated for PAH also are advised to undergo assessment for sleep-disordered breathing, a potential independent risk factor or complicating factor for PAH. In addition, the guideline supports the continued use of right-heart catheterization to confirm the presence of PAH and establish the severity of the disease. In regard to medical therapies, the guideline recommends that women with PAH avoid becoming pregnant due to the high maternal and fetal mortality rates associated with the disease. “There are many misconceptions about PAH, since it is relatively uncommon, leading to inappropriate reliance on some tests and treatments. In addition, s ymptoms of PAH are similar to other respiratory diseases, such as asthma, and can remain subtle for months or even years. These issues have made diagnosing and managing PAH more difficult and the need for early and accurate testing crucial,” said Dr. Rubin. “ The extensive published research on PAH over the past few years affords the development of guidelines that are based on data and experience for a very serious disease. When implemented, the guidelines can l ead to earlier and more accurate diagnosis of PAH and more appropriate application of therapies now available.” Although the true incidence of PAH is unknown, it is estimated that over 100,000 people in the United States suffer from PAH and several thousand new cases are diagnosed each year. Pulmonary hypertension can develop in patients of all ages and ethnic groups, and both genders; however, women ages 20 to 40 have the highest incidence of PAH. “Evidence-based medicine provides a systematic way of practicing medicine based on a comprehensive review of clinical research findings,” said Richard S. Irwin, MD, FCCP, President of the American College of Chest Physicians. “The new evidence-based guideline for pulmonary hypertension combines clinical expertise with extensive external evidence that will enable health- care professionals to practice more effective patient-focused care.” The development of Diagnosis and Management of Pulmonary Arterial Hypertension: ACCP Evidence-Based Clinical Practice Guideline was supported by unrestricted educational grants from Actelion Pharmaceuticals US, Inc., Encysive Pharmaceuticals, and GlaxoSmithKline. To order a copy of the guidelines or for more information, contact the ACCP at 800-343-ACCP (2227) or visit the ACCP Web site at www.chestnet.org . CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at www.chestjournal.org. ACCP represents more than 15,700 members who provide clinical respiratory, critical care, and cardiothoracic patient care in the United States and throughout the world. ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. |
