Many thanks to Melissa Ralston, moderator of the Goddesses of Endometriosis email list, for finding this hair-raising story.
Overpriced Poison?
Posted: Oct 30, 2009 04:15 PM
Updated: Nov 1, 2009 11:56 PM
Doctors and a drug company may be getting rich at the expense of patients and taxpayers. Devastating side effects kept secret and ineffective government oversight.
It sounds like a movie script, but it’s playing out in reality.
Contact 13 Chief Investigator Darcy Spears talked to women in Las Vegas and across the country who are begging federal authorities to investigate and recall what they say is nothing short of overpriced poison.
“I have pain in my chest and in my ribs, the bone pain,” says 28-year-old Rachelle Fenner.
“I have severe pain in my neck and shoulder,” echoes 30-year-old Mary Orseno.
Rachelle can’t feel her shoulders or her face. Mary often can’t feel hot and cold.
Rachelle’s eyes go blurry.
Mary says, “There are some days I just burst into tears just thinking about getting out of bed.”
Both women were prescribed the same drug, Lupron Depot, for the same reason endometriosis–a medical condition in women that causes pelvic pain, irregular bleeding and possible infertility.
Rachelle recalls a couple weeks she got the shot, “I swelled up like I was five months pregnant.”
She’s been off the drug for months.
“It’s taken a lot from us,” says her husband, Derrick, with tears sliding down his face. “It really has. Every day’s a fight. You just don’t know.”
Mary took it almost five years ago.
“I could do normal things like play with my son and go out and go for a walk and go for a bike ride and all of that is just nearly impossible at this point to do those things,” she says.
Like millions of women across the country, Mary and Rachelle were told their pain would go away if they took this highly toxic cancer drug.
“Is there ever a day when you say, you know what, getting rid of the pain was worth it?” Darcy Spears asked.
“No,” Rachelle answers emphatically.
She and Mary both say they’d gladly take it all back.
“I would have lived with the endometriosis pain. That pain compared to the pain that I experience every day is nothing,” Mary said.
Lupron was originally approved in the 1980s to help men with advanced prostate cancer live longer.
But it doesn’t work for dying men, and it has significant side effects.
That’s according to two recent studies published in the Journal of the American Medical Association.
In 1990 the FDA approved it as a pain reliever for women with endometriosis.
But it’s so toxic, it’s not recommended for more than 12 months in a lifetime.
Renowned endometriosis experts like Dr. David Redwine steer clear of it altogether.
“Lupron does not make endometriosis go away so the cure rate with Lupron is zero,” Redwine explains. “So if you take the rate of essentially 100-percent side effects and compare that with a zero percent cure rate, I think it’s clear that the risks and side effects far outweigh the benefits.”
Entire websites are devoted to those who call themselves Lupron victims.
There’s a petition to Congress and letters to the FDA demanding a recall.
And an ongoing federal lawsuit filed here in Las Vegas centers on a woman who took Lupron when she was just 17 years old.
By the age of 20, she’d developed severe bone loss and has been medically diagnosed as totally and permanently disabled.
Still, many doctors keep prescribing it, citing medical studies as support.
“I would choose Lupron as a treatment for endometriosis because there’s been very good clinical studies that show that patients respond to the drug,” says Dr. Rachel McConnell of Nevada Fertility C.A.R.E.S.
“These articles come out like wolves in sheep’s clothing,” counters Dr. Redwine. “They are cloaked in what appears to be science and in many respects the results sound too good to be true.”
In some cases, they are.
The U.S. Department of Health and Human Services issued a scientific misconduct finding against a former Harvard Medical School professor who falsified and fabricated 80-percent of the data in his pro-Lupron studies.
But Dr. McConnell says she wouldn’t use Lupron if she felt there was too much risk.
“There’s a certain group of patients for whom I think it is worth it.”
Lupron is manufactured by Illinois-based Abbott Laboratories–formerly Takeda Abbott Pharmaceuticals, called TAP.
In 2001, TAP pled guilty to civil and criminal misconduct over Lupron.
They agreed to the then-largest healthcare fraud fine in history–$875 million dollars.
The U.S. Department of Justice found TAP bribed doctors to prescribe Lupron.
In addition to cash and trips, the doctors would get Lupron for free and then bill Medicare or Medicaid at $500 per dose.
Redwine says, “Doctors have been trained by medical journal articles favoring Lupron, they have been trained by listening to speakers hired by Lupron to speak at major national and international medical meetings.”
No one from Abbott Labs would go on camera.
They provided a statement saying: “Lupron has had more than two decades of clinical experience and is an important treatment option for patients with advanced prostate cancer and endometriosis. Both the benefits and risks of therapy are well known and clearly outlined in the label for consideration by physicians before recommending treatment.”
But some serious side effects reported by patients aren’t on the label.
“I’m assuming that no one ever told you that this drug can cause an immune disorder or attack your thyroid or your nervous system?” Spears asked Mary Orseno.
“No,” Mary says. “Never told, never warned. I read pretty thoroughly through the package insert before I ever took it and none of that was in there.”
She says she was only counseled about the menopause-like side-effects and the possibility of Osteoporosis.
Both Mary and the Fenners feel there’s only one answer.
“In my opinion, it’s too dangerous to be on the market,” says Mary.
“I think it’s pretty hostile stuff, what it does to the human body,” says Derrick Fenner, recalling what his wife endures on a daily basis. “I would be happy to see it off the market.”
Abbott’s rap sheet with the federal government doesn’t stop with Lupron.
Just last year, the FDA sent them a warning letter about an HIV drug they make.
FDA cites numerous violations of federal law in Abbott’s promotional materials, which “minimize the serious risks of the drug while overstating its efficacy and including unsubstantiated claims.”
