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Video: Did drugmaker hide birth control patch risks?

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    MATT LAUER, co-host: We're back now at 7:43. And this morning on TODAY INVESTIGATES , a popular method of birth control that some are saying is too dangerous. NBC 's Jeff Rossen is here with what he found out. Jeff , good morning to you.

    JEFF ROSSEN reporting: Yeah, good morning, Matt. It's very scary. We're talking about this, it's the birth control patch . And there's growing evidence it's far more risky than the pill, causing strokes and blood clots . In fact, we've uncovered its maker, Johnson Johnson , may have known about the problems for years and yet they're still selling it today.

    ROSSEN: When it first hit the market in 2002 , the birth control patch Ortho Evra was an instant hit. Time magazine called it one of the best inventions of the year. To this day, doctors have written nearly 40 million prescriptions for it.

    ROSSEN: But as sales surged, so did claims of injury and even death.

    Ms. LESLIE NIEDNER (Adrianna's Mother): She just got up and collapsed at the doorway. It -- she was gone instantly.

    ROSSEN: Adrianna Duffey was a freshmen in college, a top student athlete in perfect health. She had a serious boyfriend and told her mom she wanted to be responsible, so their doctor prescribed Ortho Evra . Did you think the patch was any more dangerous than the pill?

    Ms. NIEDNER: No. It's a Johnson Johnson product. They don't -- most trusted brand for baby products, so why would I question their birth control patch ?

    ROSSEN: But one night in her dorm room, Adrianna fell to the floor. The girl who'd been the picture of health was dead. Her family says that's when they learned the patch may be to blame. In fact, more than 2400 women claim Ortho Evra hurt them, too. And lawsuits claim more than two dozen have died, many from blood clots . That's exactly what killed Adrianna . Now her family, like thousands of others, is suing Johnson Johnson .

    Ms. NIEDNER: It's outrageous. It's horrifying. How many young women have to die from using this product before it's off the market ?

    ROSSEN: Some experts say what makes the patch too dangerous is the high level of estrogen it delivers, 60 percent more estrogen than the pill. When you swallow the pill, it's a quick hit which quickly dissolves in your system. But with the patch , estrogen keeps flowing directly into your bloodstream for an entire week. Dr. Sidney Wolfe is medical director of the watchdog group Public Citizen .

    Dr. SIDNEY WOLFE (Medical Director, Public Citizen): With the patch , it goes up and it just sort of stays up, and there's no relief of the body of the woman from getting estrogen.

    ROSSEN: And research shows that can lead to deadly blood clots and strokes. NBC News has obtained private internal documents from Johnson Johnson , the maker of the patch , that suggest they knew about the risk years ago. According to these patient reports between 2002 and 2004 , Ortho Evra was 12 times more likely to cause strokes and 18 times more likely to cause blood clots than the pill. And there's more. In 2005 , this J J vice president suddenly quit.

    ROSSEN: NBC News has obtained his resignation letter. "I have been involved in the safety evaluation of Ortho Evra since its introduction on the market ." He said research showed "the estrogenic exposure of the patch was unusually high," as was the "rate of fatalities. Compelling evidence" he said the company ignored. Therefore, he wrote, "it became impossible for me to stay in my position as VP ." Our TODAY investigation also found this lawsuit by another vice president.

    ROSSEN: He's suing Johnson Johnson for unlawful termination after he says he blew the whistle on the patch 's "dangerously high levels of estrogen" even before it came to market . The company, he said, "disregarded his concerns and launched the product" anyway.

    Dr. WOLFE: The company knew about much of it, if not all of it. They thought correctly that it wouldn't sell as well if you told people how dangerous it was.

    ROSSEN: Dr. Wolfe and his safety group have petitioned the FDA to pull Ortho Evra off the market . That was two years ago. The FDA still hasn't made a decision. In the meantime, Johnson Johnson continues settling lawsuits quietly. According to Bloomberg , the company has paid out an estimated $68 million to victims, a small number compared to the 1.6 billion they've made on sales of the patch .

    Ms. ROOPAL LUHANA (Leslie's Attorney): They're making a significant profit on this product, off the backs of people like Adrianna .

    ROSSEN: In 2006 , J J did make changes to the package's inside label, warning in fine print about the increased levels of estrogen and its own studies showing a "doubling of risks of serious blood clots ." J J would say, 'Look, we put all of the risks right there on the warning label and it's up to you, the consumer, to read it.'

    Ms. NIEDNER: There's noting in that warning that could help me understand that a patch would kill a healthy, young 17-year-old woman.

    ROSSEN: Still, not everyone is against the patch . We spoke with several doctors who continue to prescribe it. After all, they say, it's FDA approved. Yes, the health risks are higher than the pill, but, they say, they're still relatively small and worth it to protect women from becoming pregnant. But Dr. Wolfe says it's not worth it; that Ortho Evra is not only riskier, but also has a higher dropout rate than the pill and is no better at preventing pregnancy.

    Dr. WOLFE: We don't ask FDA to ban anything unless we think it's quite clear that the risks outweigh the benefits.

    ROSSEN: We wanted to speak with Johnson Johnson on camera, but the company declined our request for an interview. In an e-mail, the company also declined to answer any of our questions about the patch , citing "ongoing litigation." Instead, J J said it's "regularly disclosed scientific data regarding Ortho Evra to the FDA , the medical community and the public in a timely manner, and when used according to the FDA -approved label, Ortho Evra is safe and effective." But this mother says the patch killed her daughter, and she wants it off the market for good. Most people who've sued J J over this have settled with confidential financial agreements. Will you settle?

    Ms. NIEDNER: No. There's no amount of money that's going to give me back my daughter. And before I take money and know that other young women are going to die from this and other mothers are going to be in my situation, I'm going all the way to trial. I want them accountable for allowing this to happen.

    ROSSEN: We asked the FDA , why haven't you made a decision yet, two years later, whether to pull this product off the market ? A spokeswoman told us it's a complicated issue that takes time to review. By the way, experts say you should never stop using birth control , Matt , including the patch , even after everything you saw, until you speak with your doctor first.

    LAUER: Yeah, that's important information...

    ROSSEN: Very important.

    LAUER: ...no question. Compelling story, Jeff . Thank you very much .

By
NBC News
updated 9/22/2010 11:51:45 AM ET 2010-09-22T15:51:45

Pharmaceutical giant Johnson & Johnson may have known years ago about the deadly risks of its birth control patch Ortho Evra, according to internal documents obtained by NBC News.

Patient reports between 2002 and 2004 show that Ortho Evra was 12 times more likely to cause strokes and 18 times more likely to cause blood clots than the conventional birth control pill, NBC News' TODAY show revealed Wednesday.

When Ortho Evra first hit the market in 2002, it was a big hit. "Time" magazine called it one of the best inventions of the year and doctors have written nearly 40 million prescriptions for it. But as sales surged, so did claims of injury and even death.

Some experts say the patch is problematic because it delivers a continuous and high level of estrogen — 60 percent more estrogen than the pill. When a birth control pill is swallowed, it quickly dissolves into the system. But with the patch, estrogen keeps flowing into the bloodstream for an entire week.

"With the patch… there's no relief of the body of the woman from getting estrogen," Dr. Sidney Wolfe, Medical Director of watchdog group Public Citizen, told NBC.

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Warnings ignored
Concern over the patch has led to high-level resignations at Johnson & Johnson.

In 2005, Johnson & Johnson Vice President Dr. Patrick Caubel suddenly quit, saying in his resignation letter, "I have been involved in the safety evaluation of Ortho Evra since its introduction on the market. … The estrogenic exposure [of the patch] was unusually high, as was the rate of fatalities."

His letter, which was obtained by NBC, said the research was "compelling evidence" that the company ignored. Therefore, he wrote, "it became impossible for me to stay in my position as VP."

NBC's investigation also found a lawsuit by another Johnson & Johnson vice president, Dr. Joel Lippman, who is suing the company for unlawful termination after he says he blew the whistle on the patch's dangerously high levels of estrogen, even before it came to market.

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The company, he says, "disregarded his concerns and launched the product anyway."

"The company knew about much of it, if not all of it," said Dr. Wolfe. "They thought correctly that it wouldn't sell as well if you told people how dangerous it was."

Video: Did drugmaker hide birth control patch risks? (on this page)

Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision.

In the meantime, Johnson & Johnson continues settling lawsuits quietly. According to Bloomberg, the company has paid out an estimated $68 million to victims, a small number compared to the $1.6 billion they have made on sales of the patch.

'She was gone instantly'
Adrianna Duffy was a freshman in college, a top student athlete and in perfect health when she started on the patch. She had a serious boyfriend and told her mother that she wanted to be responsible and avoid pregnancy, so Duffy's doctor prescribed Ortho Evra.

But one night in her dorm room, on September 28, 2009, the girl who had been the picture of health fell to the floor and died. Duffy's family said that was when they learned the patch may be to blame.

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"She just got up and collapsed in the doorway. And she was gone instantly," Leslie Niedner, Duffy's mother, told NBC. "This is a Johnson & Johnson product — it's the most trusted brand for baby products, so why would I question their birth control patch?"

More than 2,400 women claim Ortho Evra hurt them as well. Lawsuits claim more than two dozen have died, many from blood clots, which was what killed Duffy. Her family and others are now suing Johnson & Johnson.

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"It's outrageous, it's horrifying," Duffy's mother said. "How many other young women have to die from using this product before it's off the market?"

Roopal Luhana of Chaffin Luhana LLP is the attorney for Leslie Niedner, Duffy's mother. "They're making a significant profit on this product, off the backs of people like Adrianna," she told NBC.

Consumer's responsibility?
In 2006, Johnson & Johnson did make changes to the patch's inside label, warning in fine print about the increased levels of estrogen, and outlining its own study showing a doubling of the risk of serious blood clots.

"There is nothing in that warning that could help me understand that a patch would kill a healthy young 17-year-old woman," Duffy's mother said.

Despite these concerns, NBC's investigation found several doctors who continue to prescribe Ortho Evra. They said it was FDA approved and, although the risks are higher than the pill, they are still relatively small and worth it to protect women from becoming pregnant.

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Dr. Wolfe, however, says that Ortho Evra is not only riskier but also has a higher dropout rate than the pill and is no better at preventing pregnancy.

"We don't ask the FDA to ban anything unless we think it's quite clear that the risks outweigh the benefits," he said.

NBC asked the FDA why it has still not made a decision, two years later, about whether to pull the product off the market. A spokeswoman said it was a complicated issue that takes time to review.

Johnson & Johnson declined NBC's request for an interview. In an email, the company also declined to answer any questions about the patch, citing "ongoing litigation."

The company also said it has "regularly disclosed scientific data regarding Ortho Evra to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, Ortho Evra [is] safe and effective."

But Adrianna Duffy's mother says she wants it off the market for good, which is why she's unlikely to settle her lawsuit.

"There is no amount of money that's going to give me back my daughter," she said.

"And before I take money and know that other young women are going to die from this and other mothers are going to be in my situation, I'm going all the way to trial. I want them accountable for allowing this to happen."

Editor's note: Experts say women should never stop using birth control, including the patch, without talking to their doctor.

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