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Wyeth Sued Over Rapamune Transplant Drug


Washington, DC: A whistleblower lawsuit has been filed by two former sales representives for Wyeth, alleging that the company, which is now owned by Pfizer, illegally promoted its kidney transplant drug Rapamune for use with other organ transplants, and targeted African American patients who are known to be a high-risk patient group due to their immune response to transplant, despite the lack of evidence to support its use in this population and notwithstanding the product labeling.

"Despite limited data on high-risk patients, Wyeth targeted transplant centers that catered primarily to African-American patients, typically in urban areas. In 2005, Wyeth's sales management selected Philadelphia's Einstein Medical Center as a center on which to focus a Wyeth marketing plan designed to rapidly increase or accelerate Rapamune sales in a 90 day period. Einstein's transplant patient population was approximately 75 percent African-American in 2005," the suit states.

The suit also states that Wyeth marketed Rapamune for an unapproved dosing regimen which it called "Conversion," despite the fact that it was never indicated for conversion use. In 2004, the FDA required Wyeth to place warnings in Rapamune's package insert pertaining to side effects of converting patients on other immunosuppressant regimens to Rapamune.

Additionally, the two former sales reps claim that Wyeth "openly encouraged and directed their entire Rapamune sales force" to promote the use of the drug among physicians involved in heart, lung, liver, pancreas and islet cell transplants, knowing that Rapamune did not have an FDA approval for those indications. The suit also claims that Wyeth offered doctors and hospitals kickbacks, in the form of speaker fees, grants and donations, in exhcange for off-label prescribing of Rapamune.

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Published on May-25-10


READER COMMENTS

Posted by
Toni Kling
on
Rapamune side effects
April 2012, prescribed 5 mg Rapamune due to reduced kidney function from being on cyclosporine for 19 years (due to a liver transplant). Two weeks later I developed a rash on my arms.
April 2012, developed frequent heart palpitations. In May and June 2012, medication reduced to 3 mgs. New symptoms developed: shortness of breath, severe weakness and fatigue, coughing, chest pressure, cannot stand for more than a few minutes at a time. (I was seen in ER for the palpitations in May. Doctor said I had low potassium, which can cause palpitations.)
Mid-June, went to ER for chest x-ray. I was admitted for 4 days due to pneumonia like symptoms, with cloudy lungs. There was no detection of bacterial or viral causes. I was put on oxygen.
Persistent: Night sweats, thick phlegm at back of throat, low potassium
June 29, 2012, symptoms are still present: weakness, shortness of breath, coughing, chest pressure, leg pain. I am still on oxygen. I have lost 25 pounds in 3 months. I have been off of Rapamune for 3 weeks now.
July 1-4, stomach ache through right-middle area. Upper leg pain in right inner and back.
July 4… feel like I am not weak or fatigued finally. Endurance is still limited though. I still need oxygen when my chest starts feeling pressure.
July 5… felt strong enough to go out for awhile.
July 6, over did it yesterday. I am tired, my right knee hurts and my chest has pressure. I need to be on oxygen.
July 7, bad stomach ache again.
July 9, coughing and heart palps today.
July 13, generally I feel stronger now. Today, though, I felt my chest pressure again and needed oxygen.
July 18, I haven’t felt the need to use oxygen. I have been working in my back bedroom, cleaning it up for my son to use. I have not felt weak and my stamina has been good. My back, though, is hurting very badly.
July 22, in the past week I have only felt the need for oxygen a few times. I have been experiencing hot flashes quite often daily. I don’t think it is related to menopause because I went through this phase over a year ago and have not menstruated since September of 2011.
August 10, hot flashes are less frequent, maybe once a day. I have all my energy back and have no need for oxygen. I recently had a chest xray showing improvement in the lungs.
August 18… I am in the ER again. This time for a kidney stone.
Sept 8 … stomach ache , hair has been falling out more than usual past month
Oct 12.. have a painful stomach ache on right front side. This occurs once or twice a week.

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