Tracleer and PPH News 3 Fen-Phen victims win $500,000
By Phil Milford and Dawn McCarty November 25, 2004 - A Pennsylvania jury awarded three women $500,000 for heart-valve damage caused by the Wyeth weight loss drug Fen-Phen while throwing out a fourth woman's claim, a lawyer for the women said. The Utah women, Diana Hilton, 63; Patricia Judd, 46; Lorraine Kofford, 56; and Krysti Kollman, 43, sued the Madison, New Jersey-based drug and health-care products maker in Philadelphia Court of Common Pleas in 2002 seeking more than $50,000 each. The jury rejected Hilton's claim. "We're disappointed in the verdict for Ms. Hilton, but we are very pleased with the awards to Ms. Judd, Ms. Kofford and Ms. Kollman," said plaintiffs' lawyer in a telephone interview. This was the 10th fen-phen case to be tried in the same Philadelphia court since July. Wyeth has set aside more than $16 billion to resolve cases involving the Fen-Phen mixture, which included the company's Pondimin or Redux and generic phentermine. The claims are specifically related to Pondimin, which was recalled from drugstores in 1997.
In his closing arguments, plaintiffs' lawyer Steven Kherkher told jurors that medical tests show the women have some heart-valve leakage and may need treatment that could include surgery as they get older. Jurors were asked to answer whether each plaintiff's injury was caused by the ingestion of Pondimin and, if so, what amount of damages she will suffer as a result of the injury.
Shares of Wyeth, which reported $15.8 billion in sales last year, fell 18 cents to $39.12 in New York Stock Exchange composite trading at 4:18 p.m.
The case is Hilton v. Wyeth, NO. 02-1201206, Philadelphia Court of Common Pleas, Philadelphia, Pennsylvania.
UPDATE: Docs Release More Findings in PH Drug Trial
by John C. Martin
06-09-05 - Researchers at a California medical conference last month unveiled more findings of a pivotal Phase 3 clinical trial testing the safety and efficacy of an investigational medication for pulmonary arterial hypertension.1 The trial is one of the bases for a pharmaceutical manufacturer's move to seek approval of the drug from the U.S. government.
A Hidden Cause
Pulmonary hypertension is a rare lung disorder in which the blood pressure in the pulmonary artery—which runs from the heart to the lungs—rises far above normal levels. The reason is still unknown. This abnormally high blood pressure, in turn, leads to abnormal changes in the small blood vessels in the lungs. Increased resistance to blood flowing through the vessels results, placing a strain on the heart's right ventricle, eventually leading to right-heart failure, and possible death. In the United States, about 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year. More women than men are diagnosed, according to estimates, and it's most commonly found in those between ages 20 and 40.2
Comparing Thelin to Placebo
The trial, lasting 18 weeks, put the drug Thelin, also known by its generic name sitaxsentan, to the test in a group of 246 patients with the disease. The participants were assigned at random to groups receiving one of two doses of the medication, or a group given a placebo as a comparison. A group in the study also received the already approved PH drug, Tracleer (bosentan), to compare the results.
The study investigators reported Thelin improved the distance that patients were able to walk in a standard 6-minute test. This was seen particularly in those taking 100 mg doses. Their walking distance increased "significantly", according to the drug's maker, Encysive Pharmaceuticals, by an additional 31 meters (34.3 yards) versus those on placebo.
By contrast, those taking Tracleer increased their walking distance in 6 minutes by about 29 meters (32.3 yards), the study team reported. While that was also a positive finding, it was later found that starting at week 12 of the study, those taking 100 mg of Thelin continued to improve, whereas those taking Tracleer "trended down". Thelin also improved function (based on WHO criteria) compared to placebo, but Tracleer did not, the investigators noted.
Patients were also assigned 50-milligram doses of the drug, but the investigators said the findings in that group were not significant. Thus, Encysive says it doubts the drug will be made available to patients at this dose.
Encysive Seeks FDA Endorsement
"We are very pleased with the clinical results of our second-generation, selective endothelin antagonist, whether compared to placebo or to bosentan, the only approved oral product for pulmonary arterial hypertension," said Bruce Given, MD, Encysive's President and CEO, in a company press release. "Data from [this trial] and our other Phase 2 and 3 studies form the basis of our New Drug Application", which was scheduled to be filed in May.
Side effects reported in trials of Thelin include headache, edema (fluid build-up), nausea, upper respiratory tract infection, dizziness, insomnia, nasopharyngitis, and nasal congestion.3
1. ATS 2005. The International Conference of the American Thoracic Society. 2005 May 20-25. San Diego, CA.
2. American Heart Association. Primary or Unexplained Pulmonary Hypertension. Available at: http://www.americanheart.org/presenter.jhtml?identifier=4752. Accessed June 9, 2005.
3. Barst RJ, Langleben D, Frost A et al. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004 Feb 15;169(4):441-7. Epub 2003 Nov 20.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
Hoping Lung transplant could give area woman a second chance
By Susan Glairon
The Daily Times-Call
LONGMONT — 3/26/2006 - Most days, Nicole Poulin stays home and waits. She watches television. She spins wool and knits shawls and bags. She plays with her poodle and two cats, often having long conversations with them because she’s so lonely. Meanwhile, time goes by. Precious time.
Poulin, who turns 32 on Monday, needs a lung transplant. Without it, she could die.
“It’s awful waiting,” says Poulin, who has been on the national registry for a lung transplant for 16 months. “I feel like I’m just in my house doing nothing, waiting for my life to start over again.”
Almost three years ago, the Longmont woman was diagnosed with pulmonary arterial hypertension, a rare disease that causes her to lose her breath with very little exertion. Picking something off the floor will wind her, even with oxygen delivered through a tube draped by her nose. Without it, just sitting and talking could be difficult, she says.
The disease causes narrowing and stiffening of the pulmonary artery, the blood vessel that leads from the right side of the heart to the lungs, leading to above-normal blood pressure. The pressure causes extra stress on the heart and lungs and ultimately can lead to heart failure. Typical symptoms include shortness of breath, especially with exertion; fatigue; dizziness; fainting; and swelling and edema in the lower extremities.
The disease typically affects women between the ages of 20 and 60. It is twice as common in women as it is in men.
Pulmonary hypertension afflicts about 100,000 to 200,000 people worldwide, yet many of these individuals probably haven’t been diagnosed, according to the Pulmonary Hypertension Association. Symptoms can be mistaken for those of other conditions, such as asthma, allergies and even sleep apnea or a lack of exercise.
“It’s important to realize that people who have pulmonary hypertension a lot of times don’t look sick,” Poulin says.
Until she gets a transplant, walking around the apartment is about all Poulin can physically handle. A woman comes four times a week to help with housework and shopping. Her brother, who lives in Boulder, takes her to medical appointments.
Through her lung transplant support group at University of Colorado Hospital in Denver, she has seen the difference a transplant can make. Those who had transplants can move around freely without oxygen, she says.
Fortunate move
During the spring of 2002, Poulin left a finance position and moved from the Boston area to Colorado to study massage therapy, be closer to her brother and enjoy the outdoors. Little did she know that the move also would place her close to what later would become her lifeline — University of Colorado Hospital in Denver, which houses one of the largest pulmonary hypertension programs in the world.
The program offers clinical patient care as well as research and investigation of new drugs. It also performs 30 to 40 lung transplants each year.
Before she became ill, Poulin enjoyed swimming, scuba diving, hiking and camping.
Shortly before she moved, she experienced shortness of breath and heart palpitations, usually after working out.
After starting her physically demanding program at the Boulder School of Massage Therapy, she began having chest pains and severe shortness of breath.
It became more difficult to exercise, and Poulin first thought she was simply out of shape.
Doctors initially diagnosed her with asthma. But in June 2003, roughly a year after she started talking to doctors about her symptoms, she finally received the correct diagnosis.
There are many possible causes of pulmonary hypertension, including scleroderma, congenital heart disease, liver disease or underlying lung disease such as emphysema, says her physician, Dr. David Badesch, professor of medicine in pulmonary and critical care medicine and cardiology at CU Hospital.
But Poulin has primary or idiopathic pulmonary hypertension, an extremely rare form of the malady that has no apparent cause, he says. The idiopathic version occurs in about two people per million per year, according to the Silver Spring, Md.-based Pulmonary Hypertension Association.
In the 1980s, the median survival rate for someone with pulmonary hypertension was less than three years from the date of diagnosis, and patients died from the failure of the right side of the heart. But today, with new medications, patients can live 15 to 20 years or longer, and lung transplants can often be delayed, Badesch says.
“We are much better able to care for these patients than a decade ago,” he says.
Still, Poulin has tried five drugs recently approved by the FDA, and her condition has worsened. She is high on the priority list for a lung transplant. She carries an infusion pump to administer the drug Epoprostenol continuously through a shunt in her chest, which helps open up the blood vessels in the lungs and improve blood flow.
Although those who have a transplant are susceptible to rejection or infection, Badesch says a lung transplant can give Poulin a new life. The five-year survival rate after a lung transplant is around 50 percent, and some recipients live 10 years or more.
After her transplant, Poulin hopes to go back to school to become a science or history teacher.
She stresses the importance of becoming an organ donor, not just for herself but for everyone who is waiting for an organ, including children.
“It’s so important,” she says. “You can really change people’s lives and give them a second chance.”
Susan Glairon can be reach at 303-684-5224 or by e-mail at sglairon@times-call.com.
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