Senate Judiciary Committee Refers Planned Parenthood to FBI for Criminal Investigation; With Financial and Cultueral Challenges, Are Families An Endangered Species? FDA Requires ESSURE Warning Labels on All Packages Due to Hundreds of Serious Complications
PRI Review for December 22, 2016
Senate Refers Planned Parenthood For FBI Investigation;
Are Families An Endangered Species? FDA Requires ESSURE Warnings
Since the scandal broke over the sale of aborted baby parts, Senator Chuck Grassley has been investigating Planned Parenthood. The result is a bombshell that might be lost in the rush of Christmas news, as well as the ongoing transition.
Here’s the pertinent news:
Planned Parenthood is being referred for criminal investigation to the Justice Department and the FBI.
And bear in mind that the Justice Department that does the investigating will not be Obama’s notoriously incompetent gang of political hacks. This is a vital investigation that should finally show results.
Dateline WASHINGTON – Following an investigation into the practice of fetal tissue transfers and the federal laws governing the practice, Senate Judiciary Committee Chairman Chuck Grassley is referring several Planned Parenthood affiliates and companies involved in fetal tissue transfers, as well as the Planned Parenthood Federation of America, to the FBI and the Department of Justice for investigation and possible prosecution.
“I don’t take lightly making a criminal referral. But, the seeming disregard for the law by these entities has been fueled by decades of utter failure by the Justice Department to enforce it,” Grassley said. “And, unless there is a renewed commitment by everyone involved against commercializing the trade in aborted fetal body parts for profit, then the problem is likely to continue.”
Grassley’s referral follows the completion of a Senate Judiciary Committee majority staff analysis of more than 20,000 pages of documents provided voluntarily by the organizations and companies involved. While the impetus for the investigation was the release of a series of videos regarding transfers of fetal tissue by the Center for Medical Progress, the committee’s analysis and findings are based strictly on the documents obtained independently from tissue procurement companies and Planned Parenthood.
The Majority Staff Report concludes:
· Despite the clear legislative history of the 1993 NIH Revitalization Act, the executive branch across multiple administrations has failed to enforce the law’s safeguards.
· Since 2010, three companies – Advanced Bioscience Resources, Inc.; StemExpress, LLC; and Novogenix Laboratories, LLC (Novogenix has since gone out of business) – have paid affiliates of Planned Parenthood Federation of America to acquire aborted fetuses, and then sold the fetal tissue to their respective customers at substantially higher prices than their documented costs.
· The Planned Parenthood Federation of America (PPFA) initially had a policy in place to ensure its affiliates were complying with the law, but the affiliates failed to follow its fetal tissue reimbursement policy. When PPFA learned in 2011 of this situation, PPFA cancelled the policy rather than exercise oversight to bring the affiliates back into compliance. Thus, PPFA not only turned a blind eye to the affiliates’ violations of its fetal tissue policy, but also altered its own oversight procedures enabling those affiliates’ practices to continue unimpeded.
· The cost analyses provided by affiliates of Planned Parenthood for America lack sufficient documentation and rely on unreasonably broad and vague claims of costs for “the transportation, implantation, processing, preservation, quality control or storage of” fetal tissue. Planned Parenthood attorneys acknowledge that the affiliates had failed to follow procedures put in place to ensure compliance with the law. In addition, the cost analyses were only performed long after the fact and at the insistence of the committee.
The full report details the long history of the controversy surrounding human fetal tissue research and the bipartisan legislative approach taken to resolve the issue at the time, as well as the subsequent lack of enforcement. As the report explains, “Support for the 1993 NIH Revitalization Act was premised on the idea that the ban on buying or selling fetal tissue would be a safeguard against the development for a market for human fetuses. Tragically, the executive branch has either failed or simply refused to enforce that safeguard. As a result, contrary to the intent of the law, companies have charged thousands of dollars for specimens removed from a single aborted fetus; they have claimed the fees they charged only recovered acceptable costs when they had not, in fact, conducted any analysis of their costs when setting the fees; and their post hoc accounting rationalizations invoked indirect and tenuously-related costs in an attempt to justify their fees.”
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HV Podcast families, mortgages, and poverty
Reports have appeared in the news recently indicating that, all other things being equal, marriage is more common among people of means then among the poor.
Of course, that is a snapshot. A simple look behind the statistic can be quite revealing, because the family is a lot more than a mere economical unit.
It’s true that, for Aristotle, the family is where economics begins. And that's still true today. High schools used to have courses in "home economics," teaching students the basics of running a household, because the home was the smallest social economic unit.
But for Aristotle the family was about a lot more than economics. It was about education, the rearing of children, the formation of good habits, and providing the foundation for a society pursuing what we would today call the common good, based on a common view of civic virtue and a fundamental sense of mutual responsibility.
Our secularized society today sees things differently. The French Revolutionaries worshiped equality; today's version is called diversity. Those who worship this pagan goddess deny the very notion of the common good because, after all, we have nothing in common to be good about. “What's good for you might not be good for me,” as the newly-minted “old saying” goes. This is the slogan of the prophets of what Pope Benedict calls the Dictatorship of Relativism. The notion of virtue is offensive to such profligates, because it is so judgmental and anti-progressive.
Unfortunately, this attitude has seeped into our nation's prevailing education system. As virtually every truth is challenged, so-called educators have realized that there isn’t very much “truth” left to educate children about. Instead, they have adopted a superficial curriculum that warns students against offending anyone – except for Christians, of course. After all, Christians are backward nostalgia freaks who just don't want anybody to have any fun after sex education class.
At the college level, this educational drivel has come to be called "the school of the politically correct," or "PC" for short. And that brings us back to the challenge facing the families of the future.
Now, these reports addressing the issues of relative wealth and marriage emerged as part of a larger conversation on the difficulty that today's twentysomethings have in finding gainful employment – or, indeed, in finding any work at all.
A good part of this problem – and it is a problem – can be attributed to the nation’s struggling economy. But there is another dimension that gets less coverage in the modern media because it is less harmonious with the new paganism. Let's take a typical middle-class family, a married couple with two children.
Economically, they’re on solid footing.
Now they get divorced.
What happens? Now we have two households instead of one, each new household with a net worth reduced by more than half of the one they used to share.
After the lawyers’ fees and the cost of establishing two new households, consider the emotional and physical wear and tear on the family, the kids, and the ability of everybody involved to fulfill their responsibilities at work, school, and home.
There are countless catalysts for today's trend to marry late or not at all. College students will tell you that, while they might be nervous about marriage, they are really terrorized by the prospect of divorce. Young women, especially, recognize that, through no fault of their own, they could be left by the side of the road with their children after a quick, cheap, and easy no-fault divorce case lodged by a husband who simply decided he was going to move on.
These newly-single mothers ("unwed," in pre-Woodstock vernacular) are much more likely to be poor than married mothers. Their children are much more likely to perform poorly in school, at work, and in social interactions.
According to justice department figures, boys who grow up in fatherless homes are much more likely to be in trouble with the law in their teenage years, as well as later on in life. Girls who grow up without a father in the home will lack judgment and paternal guidance when choosing their male companions, a recipe for social – and sexual – disaster.
Moreover, mortgages are affordable only to those with decent salaries. Those come with a serious college education (which a degree these days does not guarantee). And, whether "educated" or not, the college grad has a debt that is often greater than a mortgage.
This poses a special threat to the college student graduating next May with intentions of getting a job, getting married, and having a family. Now 60 years ago, the vast majority of American women were married by the time they were 25 years old. That's where the term "baby boom" was born, which began after millions of men came home from the wars, married, and had children.
Today, an uncomfortable percentage of 25-year-olds are still living at home – that is, the home they grew up in. In fact, the single provision of Obama care that is popular allows children to stay on their parents health insurance policies until they are 26 years old. Granted, the young are least likely actually to use such benefits, but when the new Congress convenes and repeals ObamaCare, whatever new legislation they devise will certainly include that provision.
You don't need to be a statistician to realize that not only are men and women not getting married by age 25, many are not bothering to get married at all. Ask your local pastor how many wedding Masses he's celebrated this year. In most parishes, the number has fallen at a staggering rate.
So let's return to our theme. The pollsters tell us that people of financial means are more likely to be married than those in poverty. But they don't tell us why. They don't tell us how many people are in poverty because they grew up in a fatherless home, or preferred live-in arrangements to marriage, or are divorced themselves.
There is one suggested corollary that we must avoid: if a couple is rich enough, we might assume that they will still be financially intact should they divorce; but that isn't the whole story. Rich fatherless homes can cause just as much damage to the young as poor ones.
You might recall the Sandy Hook shooting four years ago this week, when 20-year-old Adam Lanza killed 20 students and six teachers after killing his mother at home.
None of the news reports tells the truth about Adams family. In fact, his Wikipedia entry tells us that he was homeschooled through high school by his mother and father. That is a lie.
In fact, when Adam was nine – 11 years before the Sandy Hook shooting – Adam's father, a rich and very successful Manhattan businessman, dumped his wife and moved in with his girlfriend closer to New York. However, because his wife had multiple sclerosis, he "charitably" did not divorce her, because his very handsome health insurance policy could thus pay for her expensive care.
Adam Lanza grew up in a fatherless home. That his separated parents were wealthy meant nothing. That he grew up in a fatherless home meant nothing to the secular media, because they realize that even telling the simple truth would invite speculation based on the simple natural law of cause and effect: dad leaves home, children go bad.
But that is not only a truism, it is true. I ran across a Justice Department report recently reporting that, based on statistics, a child born of an unwed mother living with a series of boyfriends was 20 or 30 times more likely to fail in school, fail at work, and wind up in trouble with the law than a child who grew up with his biological married parents in the same home until the age of 17.
Aristotle was right. The family is not only society's basic economic unit, the family is the foundation of society itself. But today, we are told – in fact we are forced to acknowledge – that "family" means whatever somebody wants it to mean.
In Through the Looking Glass, Lewis Carroll gives us a vivid picture of the result of this twisted distortion of reality.
Our friend Humpty Dumpty is speaking to Alice, who is wandering through a maze of narcissists who love themselves more than anything. Here's how that account goes:
“When I use a word,” Humpty Dumpty said, in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.” “The question is,” said Alice, “whether you can make words mean so many different things.” “The question is,” said Humpty Dumpty, “which is to be master—that's all.”
That's right folks. He who controls the language controls everything. George Orwell had it right in 1984, and the bloody Soviet dictator Stalin had it right when he wrote an entire book on the importance of language and power shortly before he died.
The Dictatorship of Relativism features a broad array of Humpty Dumpty's. But Through the Looking Glass is a cautionary tale. We recall what happened to Humpty Dumpty when he took a great fall. That can happen to societies too.
This is PRI Review from www.pop.org. We’ll be right back.
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The U.S. Food and Drug Administration (FDA) has announced that it has approved a boxed warning for Bayer’s controversial Essure® sterilization device. A boxed warning is the strongest warning the FDA can require for drugs and devices and is intended to alert the user to potentially serious, even deadly, side effects that can result from using them.
The Essure boxed warning will alert patients and health professionals to adverse events associated with the device including the possibility for uterine perforation, chronic pain, serious allergic reactions, device migration into the abdominal or pelvic cavity, and the need for the device to be removed surgically if symptoms become unbearable.
More than 10,000 women who have suffered adverse medical events associated with Essure have already filed complaints with the FDA, and the number continues to rise daily. Nearly 5,000 women have filed complaints with the FDA this year alone. Bayer itself has received close to 30,000 additional complaints from users of its device.
The combination of the public outcry and the unusually high number of complaints led the FDA to conduct a hearing on safety issues surrounding the device last September.
This February, the FDA announced that it had ordered Bayer to add a boxed warning to the Essure product label to better inform women of the risks involved with using the device. In order to better assess the device’s safety, the FDA also mandated Bayer to conduct a post-marketing study, an observational-based study that drug companies are sometimes required to conduct after the device has been released to the public. Bayer is being given seven years to complete the study, the results of which are not expected to be available until 2023. In the meantime, Bayer will still be able to continue selling its Essure system in the U.S.
On October 31st, the FDA released the final draft of its recommendations for changes to the Essure label. The boxed warning was released to the public on November 15th. Additionally, a patient checklist was added to assure that doctors adequately communicate to potential users the possible risks of using Essure.
While a number of changes have been made to the Essure product label, the revisions have come about after tens of thousands of women have already been harmed by the device. For some, the label changes have been too late. Essure has been on the U.S. market for over 14 years.
Essure is a device inserted into the fallopian tubes without surgery that eventually sterilizes the patient. The device consists of stainless steel rods coated in plastic and encased within a nickel-titanium alloy coil. The plastic fibers, polyethylene terephthalate (PET), cause the surrounding tissue to become inflamed and grow into the coil after about 3 months. The metal coils remain in the fallopian tubes for life unless surgically removed. The plastic material in the Essure device is the same material used to manufacture disposable water bottles and automobile tire yarns.
During clinical trials, the device had been associated with a number of adverse side effects including back pain (9% of women in the trial), severe menstrual cramps or severe abdominal pain (2.9% and 2.5%), severe abnormal bleeding (1.9%), painful intercourse (3.6%), and infection (1.5%).
For many women, Essure has been a cause for physical pain ranging anywhere from mild discomfort to unbearable chronic pain. One recently submitted, unverified adverse event report illustrates the sort of day-to-day discomfort that many women have said that Essure has caused them:
“[I] had sharp stabbing pains when bending to pick something up, when bending to shave my legs, when sitting Indian style, when lifting my leg to get in my truck and sometimes when lying in bed.”
For some women, the metal coils have migrated or perforated the fallopian tubes, intestines, or other organs. For still other women, the pain caused by the coils or a severe allergic reaction to nickel have required them to undergo surgery or even in a few cases a hysterectomy to remove the device.
A recent study published in the BMJ (British Medical Journal) looked through data of over 8,000 women receiving hysteroscopic sterilization like Essure and over 44,000 women receiving laparoscopic sterilization (traditional surgical sterilization) in New York state. The study found that women using hysteroscopic sterilization methods like Essure were more than ten times more likely than women who had been surgically sterilized to have required a reoperation procedure on the fallopian tubes within the first year.
Although Essure is supposed to make women using the device sterile, pregnancy is still possible, especially before the end of the first three months when the device causes complete tubal occlusion. This fact was made obvious when Essure’s celebrity spokeswoman, Olympic skier and gold medalist Picabo Street, became pregnant while using Essure. Bayer was forced to remove all references to Street from their promotional materials.
When pregnancies do occur with Essure, they are more likely to be ectopic. Pregnancy loss due to ruptured membranes, possibly as a result of puncturing from the Essure coil, has also been reported, according to Bayer. As of February of this year, almost half of all pregnancies with Essure (294 out of 631) resulted in pregnancy loss.
While the FDA’s belated move is a step in the right direction, many want to see the device banned from the U.S. market altogether.
“The latest recommendations from the FDA do not go far enough,” Congressman Mike Fitzpatrick (PA–8) said in a released statement concerning the FDA’s approval of a new boxed warning for Essure, “a boxed warning and patient checklist highlight the severe risks of Essure—but they’re not legally enforceable requirements.”
Last year, Rep. Fitzpatrick introduced a bipartisan bill in Congress called the E-Free Act which would circumvent the FDA and ban the Essure device outright.
“Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths,” Rep. Fitzpatrick said in his released statement.
A number of lawsuits have also been filed against Bayer in the United States and Canada. One lawsuit alleges that Bayer unlawfully incentivized the device in order to gain a larger share of patients in the contraceptive commodities market. The lawyers arguing the case allege that Bayer provided free hysteroscopic equipment in exchange for an agreement from doctors that they would purchase at minimum two Essure kits per month regardless of whether or not their patients use them.
“The FDA seems to go out of its way to protect dangerous contraceptive drugs and devices,” says PRI President Steven Mosher, “Essure is the worst example of the lot. Norplant was taken off the market after the FDA had received only 6,000 complaints. Essure has received over 10,000 complaints already. It is time for the FDA to act to protect women from this dangerous device.”
This is PRI Review from www.pop.org. Thanks for listening.
