Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Thursday, February 18, 2016

“Corporate criminals routinely escape meaningful prosecution for their misconduct.”

Elizabeth Warren: One Way to Rebuild Our Institutions

By ELIZABETH WARREN JAN. 29, 2016 The New York Times   The Opinion Pages | OP-ED CONTRIBUTOR
WASHINGTON — WHILE presidential candidates from both parties feverishly pitch their legislative agendas, voters should also consider what presidents can do without Congress. Agency rules, executive actions and decisions about how vigorously to enforce certain laws will have an impact on every American, without a single new bill introduced in Congress.
The Obama administration has a substantial track record on agency rules and executive actions. It has used these tools to protect retirement savings, expand overtime pay, prohibit discrimination against L.G.B.T. employees who work for the government and federal contractors, and rein in carbon pollution. These accomplishments matter.
Whether the next president will build on them, or reverse them, is a central issue in the 2016 election. But the administration’s record on enforcement falls short — and federal enforcement of laws that already exist has received far too little attention on the campaign trail.
I just released a report examining 20 of the worst federal enforcement failures in 2015. Its conclusion: “Corporate criminals routinely escape meaningful prosecution for their misconduct.”
In a single year, in case after case, across many sectors of the economy, federal agencies caught big companies breaking the law — defrauding taxpayers, covering up deadly safety problems, even precipitating the financial collapse in 2008 — and let them off the hook with barely a slap on the wrist. Often, companies paid meager fines, which some will try to write off as a tax deduction.
The failure to adequately punish big corporations or their executives when they break the law undermines the foundations of this great country. Justice cannot mean a prison sentence for a teenager who steals a car, but nothing more than a sideways glance at a C.E.O. who quietly engineers the theft of billions of dollars.
These enforcement failures demean our principles. They also represent missed opportunities to address some of the nation’s most pressing challenges. Consider just two areas — college affordability and health care — where robust enforcement of current law could help millions of people.
When the Education Management Corporation, the nation’s second-largest for-profit college, signed up tens of thousands of students by lying about its programs, it saddled them with fraudulent degrees and huge debts. Those debts wrecked lives. Under the law, the government can bar such institutions from receiving more federal student loans. But EDMC just paid a fine and kept right on raking in federal loan money.
When Novartis, a major drug company that was already effectively on federal probation for misconduct, paid kickbacks to pharmacies to push certain drugs, it cost taxpayers hundreds of millions of dollars and undermined patient health. Under the law, the government can boot companies that defraud Medicare and Medicaid out of those programs, but when Novartis got caught, it just paid a penalty — one so laughably small that its C.E.O. said afterward that it “remains to be seen” whether his company would actually consider changing its behavior.

Enforcement isn’t about big government or small government. It’s about whether government works and who it works for. Last year, five of the world’s biggest banks, including JPMorgan Chase, pleaded guilty to criminal charges that they rigged the price of billions of dollars worth of foreign currencies. No corporation can break the law unless people in that corporation also broke the law, but no one from any of those banks has been charged. While thousands of Americans were rotting in prison for nonviolent drug convictions, JPMorgan Chase was so chastened by pleading guilty to a crime that it awarded Jamie Dimon, its C.E.O., a 35 percent raise.

To be fair, weak enforcement is sometimes a result of limited authority. Despite the company’s history of egregious safety failures, for example, the former C.E.O. of Massey Energy was convicted only of a single misdemeanor in the deadly Upper Big Branch mine disaster that killed 29 miners in West Virginia in 2010, because federal mining laws are too weak. It’s on Congress to stiffen such penalties.
But in many instances, weak enforcement by federal agencies is about the people at the top. Presidents don’t control most day-to-day enforcement decisions, but they do nominate the heads of all the agencies, and these choices make all the difference. Strong leaders at the Environmental Protection Agency, the Consumer Financial Protection Bureau and the Labor Department have pushed those agencies to forge ahead with powerful initiatives to protect the environment, consumers and workers. The Special Inspector General for the Troubled Asset Relief Program, a tiny office charged with oversight of the post-crash bank bailout, has aggressive leaders — and a far better record of holding banks and executives accountable than its bigger counterparts.
Meanwhile, the Securities and Exchange Commission, suffering under weak leadership, is far behind on issuing congressionally mandated rules to avoid the next financial crisis. It has repeatedly granted waivers so that lawbreaking companies can continue to enjoy special privileges, while the Justice Department has dodged one opportunity after another to impose meaningful accountability on big corporations and their executives.
Each of these government divisions is headed by someone nominated by the president and confirmed by the Senate. The lesson is clear: Personnel is policy.
Legislative agendas matter, but voters should also ask which presidential candidates they trust with the extraordinary power to choose who will fight on the front lines to enforce the laws. The next president can rebuild faith in our institutions by honoring the simple notion that nobody is above the law, but it will happen only if voters demand it.

Elizabeth Warren is a Democratic senator from Massachusetts.

Wednesday, February 17, 2016

FDA and Bayer Essure Asked to Explain: 303 Fetal Deaths and Kickbacks


Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
February 16, 2016
Dear Dr. Shuren,
As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.
Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.
However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.
In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device.
Additionally, my office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC. A copy of the complaint is enclosed.
The complaint alleges that the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.
According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up “referral lunches” to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called “coin-operated doctors,” designed to lead to the increased use of Essure. Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.
These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.
In addition to the review of 303 fetal death reports, I request that the allegations of illegal kickbacks filed against the Essure manufacturer also be included as part of the review being conducted by the FDA.
Mike Fitzpatrick
Member of Congress
Congressman says FDA grossly underestimated harm of permanent contraceptive Essure

By Shannon Muchmore  | February 17, 2016
A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.

Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.

“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.

Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device's safety and usefulness.

The FDA was not immediately available for comment.

Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.

The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”

Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.

Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.

The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.

The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports. 

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.

Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.

FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions
February 17, 2016 1:51 PM By Mike Dougherty

PHILADELPHIA (CBS) — Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that’s been the source of tens of thousands of complaints.
Bayer Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.
Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it’s responsible for more than 300 fetal deaths and countless other medical complications.
It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.
“The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money.”
Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.
“My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections.”
Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.

Women Want Bayer Essure Taken Off Market
Essure is a medical device that gets surgically inserted into a woman's fallopian tubes. It's marketed as a form of permanent sterilization for women, but it's been linked to more than 300 fetal deaths, and a group of 27,000 women on Facebook want to see it taken off the market. KYW's Mike Dougherty reports.

Mike Dougherty  Mike is a general assignment reporter and editor for KYW Newsradio 1060. His career at 1060 began as a desk assistant in January '07. A short nine months later, he was promoted to AM Drive writer while still studying broadcast journalism at Temple...

Safety and Suicide: Karen Langhart, J&J NuvaRing, Bayer and FDA

How direct-to- consumer advertising, corporate malfeasance, and conflicts of interest at the FDA have given rise to a false sense of security for women who use some forms of hormonal birth control.
This Dan Walter story was funded directly by readers like you.
It's free to read because it was shared on Facebook. Back Dan Walter, and your funding directly supports his future work — You can impact the stories that get told.


“By the time you receive this note I will have joined Erika,” a letter obtained by the Durango Herald reads. “I consider it an honor to give my life to help save the lives of others.”
There’s a video, made last summer, in which 56 year old Karen Langhart approaches a podium in a conference room in San Antonio, Texas. She takes the microphone and, with a heavy sigh, faces the audience. She drops her hands to the edges of the lectern, takes a deep breath and lets it go. It is clear that what she is doing is an effort, and that she has done it many times before. She is weary - very weary - and you can tell that she is willing herself to go on. She raises her eyes from her notes and looks out at the room, sweeps her blonde hair behind her ears and puts her reading glasses on.
She sighs heavily again and sets a grim smile.
She thanks her hosts and says that she and her husband cannot convey how much they appreciate that the film which is about to premier is dedicated “to my beloved daughter Erika and all of the other women who have lost their lives to these dangerous drugs.” She is all but crying; not actually crying because she is all cried out and has been for a long, long time.
The independent film, Natural Love Stories, is about alternatives to hormonal contraception. It was dedicated to Erika Langhart because she died at the age of 24 from massive pulmonary embolisms. In November 2011, a blood clot traveled from Erika’s leg to her lungs and cut off the blood supply, causing a series of cardiac arrests that left her brain-dead by the time her parents made it to the hospital. The doctor told them that she died because of a contraceptive she was using called NuvaRing.
Karen Langhart has told the story so many times to so many audiences since then that you’d think the rawness of it would subside. But it never did, it got worse with each telling and you can see from the video that this woman is coming apart, disintegrating before your eyes.
Without grasping the irony, Karen tells her audience that her daughter’s spirit was best captured in the Durango High School Yearbook dedication, which urged graduates to “Care more than others think wise, risk more than others think safe…”
Risk and safety, our perceptions of it as consumers, are at the core of this American family tragedy.
Karen, sniffling back the sadness that will soon drag her under, says that she appreciates the film because it gives women the information they need in order to make well-informed choices about birth control, and that she and her husband believe that if Erika had access to that information, she would be alive today.

As often happens with people whose lives are precipitously sheared in half by some sudden, incomprehensible and unacceptable tragedy, Karen became obsessed with righting the injustice of it all. The loss of a loved one through the carelessness or cunning of those entrusted with their health and safety is dealt with by taking action, transforming one’s life into a crusade. It is an effort - not to find “closure” because there can never be any such thing - but to do something with it, to channel the unstoppable flood of grief, pain and anger toward something else so that one can at least endure.
But it turns out to be less a crusade than an odyssey, with disorienting twists and turns that some people just aren’t equipped to survive.
The Langhart’s introduction to the Alice in Wonderland world of post-traumatic patient advocacy began with the discovery that the Food and Drug Administration would be holding scheduled hearings about the dangers of certain hormonal contraception within weeks of Erika’s death, but there would be no discussion about NuvaRing, nor would the Langharts be allowed to speak.
Wise counsel to their reflexive reaction that this is crazy, unfair, and makes no sense would have been to just get used to it, because you have entered a world where fairness, justice and common sense are more the exception than the rule.

Because clinical trials can only test products on a limited number of subjects, you really can’t get an idea of the full range or seriousness of unintended consequences of drugs or devices until they are used by hundreds of thousands of people.
The process of vetting a new medical product through the general public generally goes like this: If there is some latent defect, various dreadful side effects will be revealed over a period of several years with reports of hundreds of injuries and scores of deaths. At some point it starts to dawn on the medical community and the public that there’s a problem, a downside to the miracle drug. There will be news stories, lawsuits and government hearings. There will be protestations from the manufacturer that the risks are well-known and the product “has been shown to be safe and effective,” even as they settle lawsuits (stipulating confidential payouts and no admission of wrongdoing).
If they find a way to tinker with the product to reduce their legal exposure by eliminating undue risk, all the better. But as long as the legal fees, settlements, and government fines can still be figured into the overhead and the product still turns a profit, it’s business as usual. (Ford Motor Company famously set the American standard for using cost-benefit analysis in deciding that the bottom line justified the immolation of a modest number of its customers.)
This is how it unfolded for pharmaceutical birth control - except that the profit motive has engendered a repeat of the whole cycle. And this time, in the era of deregulation and direct-to-consumer advertising, Big Pharma is in a much better position to deflect criticism and responsibility - and to keep selling the products.
Dr. Frits Rosendaal is a Professor at Leiden University Medical Center in the Netherlands. He heads the Department of Clinical Epidemiology, as well as the Department of Thrombosis and Hemostasis, and has written nearly 500 papers for international journals - which qualifies him as the world’s leading expert on the self-sealing aspects of the circulatory system.  
“Coagulation is a complex system consisting of some 20 or more proteins, for it has to happen rapidly and be localized when necessary as in the case of a wound - but not otherwise - and it has to stop quickly afterwards,” Rosendaal says. “So, these proteins keep each other in a dynamic balance. This balance varies between people, and as with eye color there is variation. Some people are a bit tilted one way; they bleed more easily and clot a bit less easily, and some people tilt the other way. Those who tilt towards clotting will be more prone to develop thrombosis when they encounter a risk factor like cancer, extended air travel or hormonal contraception.”
Birth control drugs generally consist of a combination of an estrogen hormone and a synthetic form of progesterone. While this works to prevent conception, any tinkering with hormones is bound to effect other delicate systems of the body. The main repercussion of chemical contraception is its effect on the cascading factors that trigger the clotting action of blood.
The original pill, Enovid, loosed on a grateful generation of women in 1960, was launched with what turned out to be dangerously high doses of estrogen and progestin, which caused some women to develop serious blood clots. After more than ten years of side effects, deaths, corporate denials and FDA hearings, manufacturers finally reduced the amount of hormones in what became known as the second generation of pills.
The problems diminished and all was well, more or less, for a decade or so until two looming factors prodded drug manufacturers to mess with a good thing. For one thing, the market was pretty well saturated. There was a good-enough pill out there and those who wanted it took it, with little room for individual companies to increase market share. More importantly, while estrogen was not proprietary, patents on various versions of progestin would eventually expire, depriving companies of exclusive control for premium brands. This prompted development of third and fourth generation contraceptives. These were based on the same basic formula, but the progestin component was altered to include patentable derivations of the synthetic hormone. The other innovation made with an eye toward marketability was in delivery systems; the transdermal patch and the hormone-secreting vinyl ring.
The numbers, as usual, are contentious and undecipherable to all except practitioners of the dark art of statistical analysis, but they generally point to at least a doubling of the chances for dangerous blood clots for users of the third and fourth generation contraceptives, such as NuvaRing, the Ortho Nuva patch and pills such as Yaz and Yasmin.
As with the original version of the pill in the 1960’s, the adverse effects of the newer generation contraceptives have been revealed over several years as reports of injuries and deaths continued to mount.
With the intervention of their senator, John McCain, the Langhharts were given leave to speak at the FDA hearings about the dangers of the newer contraceptives.
The hearings were spread over two days. The first day’s discussion was given over to decide whether the benefits of pills which contained the fourth generation synthetic hormone drospirenone (DSRP) outweighed the risks. In other words, the question was whether birth control pills like Yaz and Yasmin, which pulled in $1.6 billion for Bayer Pharmaceuticals the year before, were too dangerous to stay on the market. The second day would be devoted to risks and benefits of the Ortho Evra contraceptive patch, which contains a third generation hormone, and what, if any, action was to be taken regarding that product.
The Yaz and Yasmin question was debated in the light of studies that had been submitted to the panel.
Three of the studies, funded by Bayer, found no additional risk from their product. Seven other studies, which had not been paid for by Bayer, all showed that the risks were indeed higher - significantly higher.
Dr. Diana Zuckerman went to Yale and did research at Harvard. She is President of the National Center for Health Research and a fellow at the University of Pennsylvania Center for Bioethics. She pointed out to the panel that the Bayer-funded studies had fraudulently misrepresented the dangers that Yaz and the other drugs posed from Venous thromboembolism (VTE) - which is what killed Erika Langhart. The panel, Zuckerman said, had been shown “some very specific examples where Bayer was misleading and misrepresenting” the risks of DSRP drugs relative to earlier generations of hormonal contraceptives.
Zuckerman was referring to a report by former FDA Commissioner Dr. David Kessler which had been provided to the panel earlier in the week, but which the panel decided not to include in the discussion on technical grounds relating to a supposed missed deadline. Kessler’s report included excerpts from internal Bayer documents:
Compared to the three other OCs [oral contraceptives], Yasmin has a several fold increase in the reporting rates for DVT [deep vein thrombosis], PE [pulmonary embolism] and confirmed VTEs [venous thromboembolism].…When considering only serious AEs [adverse events], the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude. [Emphasis added]
The panel heard from Cindy Rippe, whose daughter, Elizabeth, died from pulmonary embolisms after two months on Yasmin. Rippe gave the panel a little lecture about American exceptionalism when it comes to alerting women to the risks of DSRP drugs. “Australia warns, Canada warns, England warns. England tells their daughters that the totality of available evidence now clearly shows that the risk of venous thromboembolism for Yasmin is higher,” Rippe pointed out. “Higher. Not the same, not questionable, not unclear – higher.”
“If Elizabeth had been clearly warned that Yasmin had more risk – maybe twice as much risk as other pills – she never would have switched to Yasmin. Never,” she said. “And she would be alive today.”
They heard from Diane Ammons, a retired fifth grade teacher, who said “I am speaking for my daughter Anne today, since she is dead. She died because she trusted the U.S. medical system. She died because she took her FDA-approved medication as prescribed. DRSP killed our healthy, athletic daughter.”
Anne Ammons was a healthy, athletic young woman who died, not from blood clots, but dehydration and increased potassium levels, another risk of consuming DSRP. But her mother told the panel that “talking with anyone who would listen after Anne’s death, most women or someone they know has had a blood clot problem with drospirenone. It is not rare. That shocks us.”
The panel heard this from Joan Cummins:
“My daughter Michelle was an amazing young woman, vivacious, beautiful, accomplished. She was looked up to by her peers and cherished by her family. Michelle was extremely intelligent and was an exceptional student. At 18, she was just starting her freshman year at Elon University in North Carolina when she collapsed on her way to one of her morning classes on a day I will never forget, September 24, 2010. She was rushed to the hospital by paramedics, but died from cardiac arrest from a pulmonary embolism. My daughter was on Yaz.”
That these pills are on the market when older generation pills are available and just as effective “is worse than insanity,” Cummins said. “It is a sickness called greed. My daughter did not need Yaz. Bayer needed Yaz.”
There were 26 FDA panel members voting. The official in charge of such things declared that none of the voting members had a conflict of interest.
Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, was a panel member. Wolfe had called on the FDA to pull these drugs off the market in 2007 because of research showing that while the risk of these drugs is worse, they offer no clear advantage over earlier generation pills. He was not allowed to vote due to “an intellectual conflict of interest.”
The panel voted 15 to 11 that the benefits of Yas, Yasmin and other DSRP contraceptives outweighed the risks.
It was subsequently revealed that four of the voting members who voted “yes” had conflicts in the form of dealings with Bayer. In voting “no”, Dr. Peter Kaboli said “I wouldn’t recommend this to my patients and I wouldn’t have my daughter take it.”
It is important to note that those who voted “yes” did so mainly on the basis that even with these deaths and injuries, the overall risks of using hormonal contraceptives in general is relatively low. According to, out of the nearly 11 million women who use the drugs, about 20,000 of them will develop blood clots and about 600 of these women will die. This, according to the medical establishment, means that hormonal contraceptives are “safe enough.”
Groups like Planned Parenthood and The American College of Obstetricians and Gynecologists are OK with those odds as well. They and other proponents of leaving the newer generation drugs on the market often cite a statistic that the risks of VTE’s during pregnancy and the weeks post-partum are actually higher than when using contraceptives. So, from that perspective, you’re much better off taking your chances with hormonal birth control than getting pregnant.
But Dru West, whose 29-year old daughter Julia died in the same way as Erika Langhart, says this reasoning is faulty. She and Joe Malone, whose daughter Brittany was 23 years old when she died after using NuvaRing, did some research and discovered that in 2011, according to the Centers for Disease Control and Prevention, more U.S. women died from pulmonary embolisms while using a combined hormonal contraceptive than while pregnant or postpartum.
Most of those who voted “no” on the newer drugs said they did so because of the reasons Dr. Wolfe laid out; that the newer contraceptives pose a greater risk compared with the older generation drugs - with no appreciable benefit. Michele Orza, a policy analyst at George Washington University and the consumer representative on the panel, said she “voted no because I could not perceive any additional benefits only with these drugs. And so any additional risk, even small - and I don’t think the risk is potentially as small as some people are suggesting; -even only a 50 percent increase would represent thousands of unnecessary VTEs.”
• • •

Dr. Zuckerman later told NPR that “In my opinion, absolutely, these drugs should not be on the market because there are safer alternatives.”
The panel did vote (21 to 5) to strengthen the label. The warning was buried in a 33 page document that was less than emphatic, advising users that “the FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”
The next day’s hearings were devoted to the Ortho Evra contraceptive patch, sold by a subsidiary of the notoriously corrupt Johnson & Johnson corporation. The patch does not contain DSRP, but does deliver a much higher level of hormones. A year before this meeting, NBC reported that “the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than pill takers.”
It was after this discussion the the Langharts finally got to speak about their daughter and NuvaRing.
Rick Langhart spoke first: “On the Monday before Thanksgiving, we received a phone call from Erika’s boyfriend that something had happened to Erika and that he EMTs were at her apartment. She was heard screaming down the hall, screaming with the last breath she ever took on her own. The EMTs gave her CPR over the next hour and a half. She suffered three heart attacks, bringing the total to four. Unfortunately, the blood clot was so massive that it clogged her lungs. She never had a chance.”
It seems like Karen Langhart’s time expired just as she started to speak, but she was granted an additional two minutes, which she used to ask the panel: “Why are these third and fourth generation contraceptives prescribed to young women when they are known to have risks and there are safer second generation contraceptives out there? We believe that our daughter would still be alive had the third generation contraception not been prescribed to her. Why would you allow third and fourth generation contraception that shows no additional benefits when second generation contraception provides the ability for young women to not become pregnant as they desire?”
The experts weighed in pro and con, with Dr. Sidney Wolfe again restating that these newer generation contraceptives were much more risky and no more effective than existing birth control products and methods.
The panel voted 19-5 that the benefits of the patch outweighed the risks.
As with Yaz and Yasmin pills, they did vote to strengthen the warning label, which the J&J sales team took as yet another sharp blow. The new label changes were to be added to the dreaded “Black Box” warning which had been mandated in 2005 after reports of about two dozen deaths and thousands of injuries. Contraceptives reaped more than $1 billion for Johnson & Johnson in 2005, but the salad days for the patch were effectively over. The following year’s bottom line would suffer, the company announced, due to “labeling changes and negative media coverage concerning product safety.” (J&J made up for the loss with a twenty-fold increase in the price of contraceptives for Medicaid patients, throwing many Red States into a budget crisis.)
The purveyors of NuvaRing fully understood the effect of scary warning labels on sales. The ring was developed by the Netherlands-based pharmaceutical company Organon, which was later bought by Schering-Plough, which was subsumed by Merck shortly afterward.
When the FDA assessed the product in 2001, a clinical trial reviewer flagged the risk of thromboembolism, citing the fact that three young women had to drop out of the study because they developed blood clots. The reviewer recommended that the product label include that information.
Organon executives were having none of that. Email exchanges recovered in the course of lawsuits reveal the executives’ reluctance to convey VTE risks to consumers. “We should really try to get it out of the text,” reads one missive from headquarters. There followed months of negotiation, in which various bits of clinical information were used as “bargaining chips.” Organon cited conflicting studies and pointed out to the FDA that the clinical trials were really designed to test efficacy - not safety. Regulators acquiesced and agreed to a label that proclaimed that it was “unkown” whether there was an increased risk of developing blood clots with NuvaRing.
The folks at Organon were still not satisfied and wondered internally “What are the chances that this section can be removed altogether?”
Dr. Susan Allen, the officer who oversaw the weakening of the label in negotiations for the FDA, later left the government and joined Merck, advising the company as to the best way to head off further efforts to strengthen it. Indeed, Merck succeeded in actually having the clot risk warning weakened even more in 2013.
All that hard work paid off for shareholders of Nuvaring’s various parent companies. In 2005, when the FDA mandated the black box warning for the Ortho Evra patch, Organon made sure that the people who wrote prescriptions knew all about it, and enthusiastically touted the supposed superior safety of the ring.
Because Organon was able to dodge the Black Box warning, sales of NuvaRing currently rake in $1 billion a year for Merck, while the Ortho Evra patch has faded from the marketplace. The NuvaRing carries about the same risk for deep blood clots as the patch.
“I don’t understand why a company in the United States would allow that kind of product on the market,” Rick Langhart told CNN. “It’s not the way Americans do business. And for them to do what they do in total disregard for what’s going on. It’s criminal to me.”
Unfortunately, Rick Langhart was learning that a lot of American medical and pharmaceutical companies do business this way.
For one thing, the entire commercial infrastructure of life-altering American medical goods and services begins with clinical trials, which are generally rigged when it comes to reporting results of what’s safe and/or effective. The New York Times recently reported on how drug makers often hide negative data on side effects. Organon, it was discovered during lawsuits, hid negative data from the FDA concerning spikes in the amounts of hormones delivered by the NuvaRing, which is at the center of many of the safety complaints. Johnson & Johnson likewise hid data regarding the dangers of the Ortho Evra patch.
All this is really nothing new, since it’s pretty much an open secret that most published research findings are false anyway.
Who is supposed to protect us? The FDA, which is riddled with conflicts. You can find out why by reading this 2013 paper, Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs.
Those are just the nefarious doings on the R&D side of Big Pharma. The selling of the drugs constitutes its own catalog of crimes.
Organon USA’s sales force, for example, proved to be just as agile with ethics as its executives and scientists when it came to pushing NuvaRing. Journalist Ed Silverman reported that Organon defrauded Medicaid by lying about prices and sales figures in an attempt to generate profits and corner the market.
They sold the NuvaRing to Planned Parenthood for $3 a piece, the price they reported to Medicaid. This enabled them to appear to be complying with Medicaid’s best pricing rule and avoid paying rebates. All other wholesalers paid $34.
In short, Organon essentially gave away NuvaRing and its other contraceptives hoping that young women who went to Planned Parenthood facilities would initially be given a low-cost form of birth control. And if the gambit worked, NuvaRing or any of the three pills could become the contraceptive of choice for countless women who could be expected to engage in family planning for the next 20 years or so.
Unlike in the United States, pharmaceutical price gouging is illegal in Canada, so authorities there were not amused by Organon’s charging about $25 for NuvaRing instead of the $20 calculated by the government to be a fair price according to international standards. (The retail price in the US at the time was roughly double the international standard. Today, one NuvaRing will cost a young woman without insurance about $135 at Target.)
Perhaps the great irony in this story is that the Langharts come from solid Republican stock. Erika, who interned for Sen. John McCain on her way to earning a degree in Political Science from American University, would surely have opposed the presidential efforts of Sen. Bernie Sanders, who recently said of drug companies, “They are getting away with murder, and in some cases they are committing murder.”
Having won the battle with the FDA to eliminate the negative, NuvaRing’s makers launched an advertising campaign to accentuate the positive. If they held true to form, they would spend up to twice as much money marketing the product than they did on research and development.
A big part of that effort would have gone to lavishing attention on obstetricians and gynecologists - providing free samples and pamphlets as well as recruiting some doctors as “consultants” or “advocates”. Dr. Paula Hillard, professor of obstetrics and gynecology at Stanford University School of Medicine, was cultivated by Bayer, the makers of Yaz, as “a Key Opinion Leader” and “Yasmine Advocate.” Why all the attention? Hillard was a member of the FDA panel that voted to keep Bayer’s products on the market in 2011. Dr. Julia Johnson, Dr. Anne Burke and Dr. Elizabeth Raymond are also OB/GYNs with ties to Bayer who determined that - to them at least - the benefits of Yaz and Yasmin outweighed the risks.
The following year, American College of Obstetricians and Gynecologists (ACOG) officially took a dim view of such goings on in the form of an updated ethics statement, in which they note that “interactions with industry carry some expectations of reciprocity” and physicians “are unable to remain objective.”
Writer Carolyn Thomas puts it this way in her blog Ethical Nag:
The reasons that doctors give out these samples seem obvious: about 94% of the ACOG docs who distributed drug samples to their patients told researchers that they did so because of patients’ financial need and for convenience (76%). Some doctors cite the usefulness of letting a patient try out a short trial of a new drug to observe potential side effects or efficacy. “But fewer docs list the reason as “physicians’ knowledge about the drug” – in other words, they did not know whether or not the sample product was the most appropriate treatment (63%).”
Further bolstering ACOG’s position was a study funded by Merck which was presented at their 60th Annual Clinical Meeting in 2012, which ran with the headline “NuvaRing Users Have No Enhanced Risk for Blood Clots.”
NuvaRing’s maker was also a shameless practitioner of product placement, positioning NuvaRing posters in the backgrounds of scenes in popular television shows like Grey’s Anatomy and Scrubs.
The commercials that ran between such shows were carefully designed to portray images of upbeat, carefree young women liberated from the burden of having to take a pill everyday, while potential downsides of the drug were artfully camouflaged.
This is how the Media Literacy Project deconstructs one NuvaRing Ad:
“- Rhetorical question: The ad begins with the question “Tired of your old birth control routine?”
- Symbols: The black and white scenes, one piece swimsuits, and swim caps are all used to symbolize “old” birth control, while color scenes, two piece swimsuits, and freed hair are used to symbolize “new” birth control.
- Beautiful People: The commercial uses female models.
- Simple Solution: This product can transform someone’s life simply by its use.
- Maybe: The narrator lists a series of health risks associated with the product and says the product “might not be right for everybody.”
- Diversion: While the health risks are being presented verbally, strong, colorful images and symbols are used visually to draw attention away from what some viewers may be hearing, and possibly even override what some viewers may be hearing.
The marketing is a stark illustration of how the risks of the product are downplayed to young women, who of course are invincible and much more receptive to the overwhelming choice, convenience, and lifestyle pitches.
The message which is not conveyed to the users of NuvaRing and other contraceptives that use later generation progestens is that while the risks are relatively small, they are real and they do happen - and by choosing this product over that one, you are doubling or tripling that risk.
Dr. Frits Rosendaal compares it to using seat belts. There’s always a risk when you get on the road, and the chances are on any given day that you will not be involved in an accident. But why would you not choose the behavior that carries the lowest risk?
In the Netherlands, birthplace of the NuvaRing, the Dutch College of General Practitioners advises using a pill with second generation hormones. Across Europe, where direct-to-consumer advertising of pharmaceuticals is banned, 2nd generation contraceptives are the most widely prescribed.
The Langharts channeled their energy toward educating the public about the dangers of NuvaRing and the other late generation hormonal contraceptives. They started a foundation, Informed Choice for Amerika. They gave interviews, made the rounds on Capitol Hill and spoke to various groups. In addition to working to prevent the deaths of other young women, Karen and Rick were determined to seek justice for Erika. In suing Merck for the wrongful death of their daughter, they were not interested in monetary damages. They wanted to hold the company accountable, to have them admit responsibility and to remove the product from the market.
“That’s what we are going to do the rest of our lives. That’s kind of what we’ve got left,” Rick Langhart told
As the number of lawsuits mounted, they were consolidated into a class action suit, which Merck agreed to settle in 2014 for $100 million. About 3,800 women who were injured by the NuvaRing agreed to the settlement, which came to about $10,000 per person after legal fees. The Langharts rejected the settlement, as Merck would not have to admit to any wrongdoing and NuvaRing would stay on the market. Merck, said Rick Langhart, would be “literally getting away with murder.”
One hundred million dollars is really nothing compared to most settlements made by pharmaceutical companies that are sued for causing deaths and injuries. Fines can run into the billions of dollars.
Experts say that one of the reasons the case against Merck was not stronger was because of the warning label change in 2013. If they had been forced to put a black box warning on the label concerning the risk of clotting after so many adverse events, the legal case of the victims would have been that much stronger.
The Langharts pressed on - without their erstwhile crusading lawyer who had crunched the cold hard numbers and realized that, under the circumstances, with the class action suit settled, he had taken the case as far as it would go. Their lawyers, whom they believed would get their story before a jury, had effectively stopped working on the case after they refused the settlement offer. Their lawyers officially withdrew on July 25th, 2015, four days after Karen took the podium in San Antonio to thank the makers of Natural Love Stories for dedicating the film to Erika.
She told the group then that she knew that her case was over.
Last year, Karen told the Durango Herald that pursuing justice was painful, and she was nearly out of hope.
In September 2015, about six weeks after the talk at the Natural Love Stories premier, a San Francisco Superior Court dismissed their case. Through four years of heartbreak, anger and grief, Karen Langhart had looked toward that day when her dead daughter would have her day in court. But it was now officially not to be.
“To have that happen to our daughter, and have this happen on top of it, it’s hard to get up in the morning,” Karen Langhart told the Herald.
She posted on a blog: “It is our greatest hope, with what remains of our lives, to fulfill our goal of making a difference in the lives of others by helping to inform women about the dangers of not only the NuvaRing; but all hormonal contraceptive drugs — the pill, patch, ring and implants. We believe women deserve to be informed of the full truth about these powerful drugs.” What remained of Karen’s life was 98 days.
On January 7, 2015, she took her own life.
In 2011, the year that Erika Langhart died, Dr. Graham Dukes wrote in an essay about hormonal contraceptives that “It would seem that the move to the third generation was a matter of patents, profits and prices, no more than that.”

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Monday, February 1, 2016

How Many Adverse Events Does It Take to Get Bayer Essure Recalled By FDA? MORE !!!$$$???

Birth-control device under FDA review

By Maryellen Fillo, Conn. Health I-Team Writer | February 1, 2016 (FiDA highlight)

Alyson Hannan, of Farmington, is among the women who have had problems after having the Essure birth-control device implanted.

When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical, permanent birth-control option approved by the Food and Drug Administration.
The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on Sept. 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss and headaches.

Their public clout and a citizens’ petition prompted the FDA to launch a review of Essure, and U.S. Rep. Mike Fitzpatrick (R-Pa.) to sponsor legislation calling on the FDA to withdraw its approval for use. The controversy will come to a head in February, when the FDA is expected to complete its review, and when members of the “Essure Problems” Facebook group are heading to Washington to lobby Congressional members to support Fitzpatrick’s “E-Free Act.”
The concerns over Essure have been fueled by a January report by a federal watchdog agency, conducted at the request of U.S. Rep Rosa DeLauro, a Democrat from Connecticut’s 3rd Congressional District, that faulted the FDA for failing to adequately track and disclose safety concerns that arise after drugs go on the market. Inspectors from the Government Accountability Office expressed particular concern about the lack of tracking of products cleared under two expedited approval programs.

The lack of inadequate pre-marketing and post-marketing studies of Essure was highlighted in a recent article in the New England Journal of Medicine that was co-authored by Yale University School of Medicine researchers.
DeLauro, was among the first members of Congress to speak out against Essure, writing to the FDA in October to say she was “deeply disturbed by reports from women about severe adverse health effects they have suffered…” and calling on the agency to withdraw Essure from the market.
Essure, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted into each fallopian tube in a doctor’s office. Essure is made of nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate, or PET. The procedure, performed in a doctor’s office, takes about 10 minutes. The medical device was originally manufactured by Conceptus, which was purchased by Bayer HealthCare in 2014. Once inserted by an OB-GYN, scar tissue forms around it, blocking the tubes and preventing eggs from being fertilized.
Varying experiences
An estimated 750,000 women have received Essure. Warnings on the product include side effects such as mild cramping, vaginal bleeding and some temporary discomfort.

In response to the public outcry, Dr. Dario Mirski, Bayer’s vice president and head of U.S. medical affairs, said, “Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.”
“We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure,” Mirski said in a press release.
The FDA has received 5,093 medical device adverse reports on Essure, a majority of them citing abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration. Four adult deaths and five fetal deaths were also reported, according to the FDA.
In September, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to discuss the risks and benefits of Essure and received over 2,800 written public comments. The FDA said that it expects to complete its review by the end of February.
In the meantime, members of the “Essure Problems” Facebook group are heading to Washington on Feb. 2 to speak to Congressional members to garner support for Fitzpatrick’s “E-Free Act.”
In Connecticut, doctor’s opinions on the device vary. Dr. Henry Jacobs, an OB-GYN and president of the Connecticut State Medical Society, said he used Essure when it was first introduced, but does not generally use it now, opting instead for tubal ligation, another permanent sterilization procedure.
“There were too many factors that made me say, ‘Hey, I can do this another way’,” Jacobs said. “I think Essure is worthy of a review.”
Dr. Russell Turk of the Stamford Health Medical Group said, “Overall I feel it is good but I have had a couple of things occur but nothing bad.”
“As with any form of contraception, there are always benefits and risks,” Turk said, whose office is in the Riverside section of Greenwich.
Turk said he does the outpatient procedure in Stamford Hospital’s Tully Health Center, rather than his office.
“I don't like the idea of fishing around in a uterus in an office setting,” said Turk, noting some bigger medical groups might have more sophisticated equipment.
He said he goes to the center because “sometimes there can be problems with the insertion and if that happens we have other options like a laparoscopic tubal and are in a safe setting with the right equipment and can proceed.”
At first, Turk said he instructed his patients who wanted the Essure device to have a nickel allergy test but was advised it wasn’t necessary. He said he has never had a patient who suffered any allergic reaction to the device.
“I do ask patients if they have a nickel allergy or if they think they might,” Turk said.
Turk said his patients have requested Essure and he offers it.
“I don’t think anyone feels there is never a possibility of something going wrong,” he said. “There is no perfect form of contraception other than abstinence.”
‘E-Sisters’ ranks grow
Dr. Odie Kuiper, an OB-GYN in Avon, said he has used Essure nearly 200 times with no reported problems, but is very careful to review risks with his patients.
“I understand the request for (FDA) review, because no one wants anything that is not safe for a patient,” he said. “But I don’t think the adverse effects are common enough to take the device off the market.”
Angela Desa-Lynch of California, one of the founders of “E-Sisters,” doesn’t want to leave the decision up to the FDA.
“In 2011, when we started the page, we had just 130 women — at a time when the horrible side effects of the implant were not well publicized, and everything was all gumdrops and candy canes,” she said. “Now we are over 25,000 members, and our mission is to save other women from what we have been through.
Desa-Lynch, the mother of two sons and a daughter, had a hysterectomy to remove the coils, after it was determined she was allergic to the materials used in the device.
“I lost my hair, my teeth and felt like I always had the flu,” she said.
“It changed my life, and I don’t want my daughter to ever have it as an option. I don’t ever want her to have the opportunity to choose Essure,” she added.
Angie Firmalino, another founder of the Facebook group, said the goal is to get the device off the market.
“We plan to continue to garner for support of the ‘E-Free Act,’ ” said Firmalino, of New York. “We suspect the FDA report will call for minimal requirements for the manufacturer to change labeling and such. We need Congress to act and revoke the pre-market approval of Essure so that the civil rights of women harmed by Essure can be restored.”
Hannan, of Farmington, has coped with years of severe backache and pelvic pain; long, heavy periods; insomnia; fatigue; weight gain; and a rash and boils that covered her body. She’s missed work, her children’s activities and other social events because of the way she feels and looks.
“It has been a nightmare,” said Hannan, who is scheduled for a hysterectomy in early February to remove the coils. “I don’t think the doctor had any reason to not believe it was safe until it was too late,” she said.
Hannan’s doctor, Jennifer Grant, who is in practice at the Women’s Comprehensive Health Center and on the staff of Hartford Hospital, will perform the hysterectomy. She said that she has used the Essure device for over eight years, and that Hannan is the only one to report a problem.
“I am very curious to see if her symptoms improve after it is removed,” she said.
Hannan is convinced that once the device is removed, her health will improve. But her longer-term mission is to protect other women from the device.
“I honestly feel the product was fast-tracked due to money, and in the quest to make money, they ignored what happened to 25,000 women,” she said. “I just want it out of me. I just want to be well again.”
This story was reported under a partnership with the Connecticut Health I-Team (