Public Citizen Wants to Ban the Ortho-Evra Patch

Amie Newman

Remember Ralph Nader? The group he founded, Public Citizen, wants the patch taken off the market, claiming it's too dangerous for use.

Should the birth control patch be pulled from the market?

Calling the Ortho-Evra patch "dangerous" and "a poor choice for women", the infamous consumer advocacy group founded by Ralph Nader, Public Citizen, says definitely. The U.S. based organization claims that use of the patch causes a host of unacceptable side effects and should be removed from the market within six months (to give women enough time to find an alternate method of birth control).

Public Citizen's Not My Patch campaignPublic Citizen’s Not My Patch Campaign

Among the claims Public Citizen makes are that the Ortho-Evra patch:

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  • exposes women to "dangerous levels of estrogen" which can severely increase the risk of blood clots.

  • compared to standard birth control pills, causes an increase in side effects like breast discomfort, severe menstrual pain, nausea and vomiting.

 

Apparently, these risks were known back when it was approved for use by the FDA in 2001. Ortho-Evra, not unexpectedly, stands by the risks/benefits ratio, saying "Hormonal birth control methods have benefits and risks… The approved labeling has always stated the known risks associated with its use."

The group has set up a campaign called Not My Patch to disseminate information.

Should you agree, there is a petition circulating to encourage the FDA to ban the contraceptive method.

News Abortion

Alabama Senator Wants to Ban Abortion Because The Bible Tells Him So

Robin Marty

Never has an anti-choice politician been so blatant that his motives are purely about his religion.

Often in the last few years we’ve seen abortion bills wrapped in the guise of preserving women’s health and safety, in ending discrimination, or on medically-disproven claims. So it’s almost refreshing to listen to Alabama State Senator Shadrack McGill admit that the motive for all of his abortion restrictions is that he thinks this is what God wants him to do.

Sen. McGill makes it clear in his remarks that his upcoming “personhood” bill is as much about starting a conversation about scripture as social policy, and he quotes that scripture a lot. Via the Daily Sentinel:

“Just based on the Scripture alone, the Psalm that talks about God knowing us before he placed us in our mother’s womb, is enough for me to know that that is a life inside of a mother,” said McGill, R-Macedonia.

“So my question concerning aborted babies is, where do they go, heaven or hell? I just want to know what [people’s] perspective is.”

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The senator said that, after prayer, he thinks life begins at the moment of fertilization, be it inside the mother or “creatively outside the mother’s womb.”

“That union between the sperm and the egg is where life begins, and maybe where God places his spirit inside that child, so to speak,” McGill said. “Therefore, I would hope that the legislation that we push in the future would state that all the eggs fertilized need to be placed in the mother’s womb.”

Lucky for Sen. McGill, his bible is pretty flexible when he wants it to be. After all, it is the same bible that he claims says that teacher salaries need to be low so only those who are called to the job will do it rather than those who might be attracted by money.

Still we can at least give Sen. McGill kudos for being honest about his motives. It’s far more than we can say about most of the rest of his anti-choice compatriots.

The MDGs and Accountability: Johnson & Johnson Controversy Raises Broader Questions

Jodi Jacobson

Everyone loves "accountability." But nobody likes it. Today Johnson & Johnson got press for a small pledge for development work made at the Clinton Global Initiative while an NBC news report accused the corporation of hiding info on the deadly effects of a birth control method.  Accountability anyone?

This week, I attended portions of the international meetings underway in New York, including the Clinton Global Initiative and the United Nations Review of progress on the Millennium Development Goals.  There is much analysis around these meetings to do and much forthcoming.  However, two pieces of news that came across my screen literally simultaneously today underscored for me in real time some of my enduring unease with the promises made by governments, corporations, and large international non-profit agencies that come together on a regular basis to review commitments previously made but not met, and to make new commitments the fulfillment of which everyone apparently hopes will turn out differently than the ones before.

A big piece of these international agreements is the issue of “accountability.”  No fewer than three leaders today called for accountability of governments and international institutions to the Millennium Development Goals.  One of these was Rwanda’s President Paul Kagame:

“We in the developing world could do more. We have to reflect deeply on how we have driven this agenda so far and why we are lagging behind on these targets … we must assume effective leadership,” he said.

Another is Canadian Prime Minister Steven Harper, who stated:

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“At this summit, our discussions should be less about new agreements than accountability for existing ones. Less about lofty promises than real results. Less about narrow self-interest in sovereignty’s name, than an expanded view of mutual interest in which there is room for all to grow and prosper.”

And a third was USAID Administrator Rajiv Shah, who said the United States will press the U.N. to adopt policies that support economic growth, accountability and fighting corruption,” as well as greater use of scientific and technological advances to promote development. 

Accountability is an interesting term in different ways for each of these men. Kagame’s call for effective leadership leads one to ask what the meaning of “effective” is.  Kagame is widely believed to have snuffed out any chance of a free and fair election in Rwanda.  He has been widely criticized by human rights groups in Africa and abroad. Ruth Wedgwood writes in The New Republic that Kagame “presides over nothing more than hollow democracy. He has attacked and exiled any and all viable political opponents. The local press, as well as international journalists, have been bludgeoned and harassed.” He also is suspected of a leading role in genocide.

Harper’s call for accountability to existing agreements must mean “existing agreements for men,” because he threw out all prior agreements on women’s rights and health to serve his own “narrow self-interested” political move.  And Shah is representing a government that has as yet failed on many levels to either get rid of failed Bush-era policies in areas like HIV and AIDS (yep, we’re still funding those ineffective ab-only programs), to lift the prostitution pledge or to even fully staff the Global Health Bureau at USAID. 

It’s very popular to call for accountability but less so to actually hold powerful corporations and individuals accountable for much of anything, especially when everyone is having such a happy time making commitments to do this or that or another thing and getting lots of press and adulation.  In fact when you try to hold governments or corporations or even some NGOs accountable, they more often than not lock you out.

So I wondered about a Twitter message that announced Johnson and Johnson’s “commitment” to spend $2 million dollars per year on fighting intestinal worms and to promote healthy births.  The Clinton Global Initiative site also lists the company as promising to spend $15,000 to provide sanitary products to girls in a Kenyan slum.

These are laudable contributions in the abstract, and I know we are supposed to applaud them, but a bit paltry when you compare them to the $3.3 billion in net profits reported by Johnson & Johnson in the second quarter of 2010 alone.  But hey: It’s good press.

But of perhaps greater concern is the fact that on the same day that the commitment was made to safe births, MSNBC reported that Johnson & Johnson may have deliberately hidden information on the deadly risks of its birth control patch Ortho Evra.

According NBC, a review of internal documents obtained by the network and reported on the Today show:

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.

A video from the show is available here:

Visit msnbc.com for breaking news, world news, and news about the economy

Writing on MSNBC.com, Jeff Rossen and Robert Powell of NBC News state:

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.

The problem, according to the article, is that the patch delivers a continuous and high level of estrogen — 60 percent more estrogen than the pill. “When a birth control pill is swallowed,” notes Rossen and Powell, “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. 

 Rossen and Powell report that concern over the patch 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.”

According to the article:

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.

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.”

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, the article continues:

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.

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 told NBC.

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,” said the article.

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 the mother of Adrianna Duffy, a woman whose death was attributed to the patch, says she wants it off the market for good, which is why she’s unlikely to settle a lawsuit she has pending against Johnson & Johnson.

“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.”

So on one hand we have Johnson & Johnson, the good global citizen making a big splash at the Clinton Global Initiative in New York by making a small grant to provide sanitary products, help with intestinal worm control and work toward making births safer (exactly how is not clear).  And on the other we have Johnson & Johnson the corporation, apparently withholding information on the effects of a birth control method that was widely promoted to women in the United States as safe and effective, and which apparently was neither.

Accountability means holding people, governments, corporations and international bodies responsible for their actions. It means that Johnson & Johnson should be investigated and that the U.S. Food and Drug Administration should be a lot more transparent about what is happening with the review of this drug.

Yet it is unlikely that anyone among the large number of world leaders, corporations, and international institutions now in New York is going to “hold Johnson & Johnson” accountable by asking questions about this issue. Instead, the company is celebrated. How do global platforms such as those underway this week in New York actually undercut accountability while at the same time touting it?

It’s a question of accountability we need to be asking.