Part II: Overpriced poison?

Part II: Overpriced poison?
Posted: Nov 2, 2009 03:53 PM
Updated: Nov 2, 2009 06:22 PM

28-year-old Rachelle Fenner finds it hard some days to just get out of bed.

“Right now, my face is numb, my shoulders are numb, I feel dizzy, I just don’t ever feel good.”

“It’s horrible,” says 30-year-old Mary Orseno. “It’s debilitating. I can’t work full-time. I suffer quite a bit. I can’t play with my son the way I used to be able to play with my son.”

The stories told by Rachelle Fenner and Mary Orseno echo those of young women across the country.

Women whose doctors have prescribed Lupron for Endometriosis: a medical condition that causes pelvic pain, irregular bleeding and possible infertility.

“After I took the Lupron,” Mary recalls, “I started having more and more things go wrong.”

Mary’s been off Lupron for nearly five years.

“I was told that those things should go away after stopping taking the Lupron and for awhile they did but then came back worse.”

Dr. Rachel McConnell didn’t treat Mary, but she does prescribe Lupron for some of her Endometriosis patients.

“One of the biggest side effects I’ve always been concerned about has been Osteoporosis or Osteopenia developing, so I’m very limited. I limit the use of that medication. If a patient has used it once then I pretty much do not want them to use it again.”

Osteoporosis is a known side effect, but the seriousness has been downplayed according to a lawsuit that was filed in Clark County District Court but is now a federal case.

It centers on a woman who took Lupron when she was just 17.

By age 20, she’d developed bone loss so severe that she’s been diagnosed as totally and permanently disabled.

Lupron is made by Illinois-based Abbot Labs. They wouldn’t give us anyone to talk to on camera, but did provide a statement.

It says: “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 medical records filed with the lawsuit document other serious side effects that aren’t on Lupron’s label, like back and neck pain, severely debilitating bone loss, and thyroid disorder.

Endometriosis expert Dr. David Redwine doesn’t use Lupron because he says its risks far outweigh the benefit of temporary pelvic pain relief.

“One of the disturbing things is that some of these side effects seem to be long-lasting in women. Even women who have been off Lupron for months or years.”

In a document Abbott filed in the federal case, the manufacturer says: “Lupron is neither defective nor unreasonably dangerous when properly prepared and accompanied by proper warnings and instructions for use.”

But Dr. John Gueriguian, who spent 20 years reviewing drugs for the FDA, disputes that.

In an expert opinion he submitted for the federal lawsuit, he says the manufacturer “intentionally suppressed knowledge about the real danger associated with the use of Lupron… misleading both prescribers and patients.”

He says their studies are inadequate and they’ve “failed to put warnings in the Lupron labeling about known adverse events which were reported to FDA and known throughout the medical community.”

“I really wish the FDA would take a harder look at that,” Mary says. “Something needs to be done. And I don’t know if they’re ignoring it or they’re just not realizing it but I think they really need to take a harder look at Lupron itself.”

The FDA has more than 12,000 adverse events from Lupron patients on file right now, including more than 1100 deaths.

Most are men taking Lupron for advanced prostate cancer, and as a result of our inquiry, the FDA is evaluating Lupron’s safety as a prostate cancer treatment.

But women are dying too and we wanted to know who’s looking out for them.

We wanted to ask the FDA how many reports it takes before the government takes action?

Contact 13 sent numerous e-mails and made repeated phone calls to ask why they keep the data if they don’t use it or it doesn’t trigger something?

When does a red flag go up?

They haven’t answered any of those questions.

But they say they continue to monitor patient complaints, and if they see potential for a widespread problem, the agency will take action as needed.

“I think the FDA is just as much a victim of Big Pharma marketing as consumers are,” says Dr. Redwine.

Unless and until Congress or the FDA does something, consumers feel like they’ve got little help and even less hope.

“Pack your bags and run,” says Derrick Fenner.

We spoke to his wife, Rachelle, at the beginning of this story.

“If your doctor says the word Lupron, get up and walk out. It’s not worth it! It’s just not worth it,” he says.

Abbot Labs says everything about Lupron, from design through marketing, complied with federal law.

But here’s a little perspective for you.

According to Dr. Gueriguian–the former FDA medical officer–the pharmaceutical industry is responsible for performing all studies needed to develop a new drug.

So FDA approval is based on information provided by the drug company.

The manufacturer is also largely responsible for pre- and post-marketing safety and contents of their labeling.

FDA acknowledges the agency rarely takes a drug off the market without the approval of its manufacturer.