Preview Newsletter
Ethicon Media Monitoring 5/28/2018
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Philadelphia Judge Denies Ethicon Bid to Dismiss 120 Transvaginal Mesh Lawsuits from Mass Tort Program
May 25, 2018 | Rx Injury Help
By Laurie Villanueva
A Pennsylvania state court judge has refused to dismiss some 120 transvaginal mesh lawsuits from a mass tort proceeding currently underway in the Philadelphia Court of Common Pleas, rejecting Ethicon, Inc.’s assertion that the venue is inappropriate. -
Surgeons and politicians call for immediate ban of mesh implants made with Chinese plastic
May 27, 2018 | The Sunday Post
By Marion Scott
The calls come following claims that polypropylene resin, sourced by medical manufacturer Boston Scientific (BSc) from China and made into permanent implants, could degrade within months. -
Weak oversight of medical devices jeopardizes patient safety
May 25, 2018 | MyAJC
By Ariel Hart
Pain in her arm and lightheadedness sent Doris Jones to the emergency room at Savannah’s Memorial Health University Medical Center. -
GTx Reports Positive Results in Using Enobosarm to Treat Incontinence
May 25, 2018 | Memphis Daily News
By Michael Waddell
Memphis-based biopharmaceutical company GTx Inc. has deep roots in Memphis, with AutoZone founder Pitt Hyde being a primary backer of the company since its inception in 1997. -
Vaginal implants concern: contact your GP
May 25, 2018 | Isle of Man Today
Women who are worried following the vaginal mesh implant revelations in the UK should contact their GP, says Health Minister David Ashford. -
Hernia Mesh: An Absolute Health Disaster
May 26, 2018 | The Ring of Fire Network
By Mike Papantonio
...You kind of led the charge on the vaginal mesh. They were putting this mesh inside women’s vaginas, and inside they’re trying to hold up the kidney, and the urinary system. Explain that case, because this is just an extension of that, isn’t it?
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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May 25, 2018 | Rx Injury Help
By Laurie Villanueva
A Pennsylvania state court judge has refused to dismiss some 120 transvaginal mesh lawsuits from a mass tort proceeding currently underway in the Philadelphia Court of Common Pleas, rejecting Ethicon, Inc.’s assertion that the venue is inappropriate.
All of the lawsuits were filed on behalf of plaintiffs who reside outside of Pennsylvania. In seeking their dismissal from the venue, Ethicon had cited the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb v. Superior Court of California, which limited plaintiffs to filing suit in jurisdictions where defendants are headquartered or where a plaintiffs’ injuries are alleged to have occurred.
However, Judge Arnold New rejected those arguments in an order dated May 18th, noting that Bucks County, Pennsylvania-based Secant had manufactured an “integral portion” of Ethicon’s pelvic mesh devices.
“For each of these devices, Secant Medical Inc. knits Prolene filament into mesh according to specifications set forth by moving defendants at its Bucks County facility before returning the knitted mesh to moving defendants for further processing,” New wrote. “Since a portion of the manufacturing process of the Gynemesh/Gynemesh PS, Prolene, Prolift, Prosima, TVT, TVT-Exact, TVT-Obturator and TVT-Secur pelvic mesh medical devices occurs in Pennsylvania, this court’s exercise of specific personal jurisdiction comports with traditional notions of fair play and substantial justice.”
Transvaginal Mesh: What’s the Problem?
More than 100,000 plaintiffs have filed lawsuits in courts across the country over injuries and complications they allegedly sustained due to defective transvaginal mesh implants marketed by Ethicon and other medical device manufacturers.
Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the serious complications that have been reported regarding these devices, including mesh perforation, mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. Three years later, the agency reversed its prior position that transvaginal mesh complications were a rare occurrence.
In 2016, the FDA reclassified transvaginal mesh indicated for pelvic organ prolapse surgery as high-risk medical devices.
Among other things, the reclassification prevents such implants from obtaining regulatory clearance through the agency 510(k) program, which does not require a new medical product to undergo human clinical trials before coming to market if a manufacturer can show that it is “substantially equivalent” to a previously-approved device.
Pennsylvania Transvaginal Mesh Verdicts
The Pennsylvania mass tort program has already tried a half dozen Ethicon transvaginal mesh lawsuits.
The most recent case concluded last fall, when a Philadelphia jury awarded $57 million in punitive and compensatory damages to a woman who said she had endured chronic pain since receiving Ethicon’s TVT-O mesh device in 2007.
Four other Pennsylvania cases have concluded in favor of plaintiffs, with damages ranging from $2.16 million to $20 million.
https://www.rxinjuryhelp.com/news/2018/05/25/philadelphia-judge-denies-ethicon-bid-to-dismiss-120-transvaginal-mesh-lawsuits-from-mass-tort/
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Surgeons and politicians call for immediate ban of mesh implants made with Chinese plastic
May 27, 2018 | The Sunday Post
By Marion Scott
The calls come following claims that polypropylene resin, sourced by medical manufacturer Boston Scientific (BSc) from China and made into permanent implants, could degrade within months.
One of the world’s top plastics experts, Duane Priddy, told US television current affairs programme 60 Minutes, that implants made of the material could only “last months” instead of up to 40 years.
He was backed by US surgeon Michael Margolis who said implants made by Boston Scientific had shrunk inside patients’ bodies by “up to 50%”.
Yesterday, consultant Wael Agur, who advised the Scottish Government’s mesh safety review, said devices made after 2012 which contain Chinese sourced resin should be withdrawn immediately.
The surgeon, who has given evidence across the world on the injuries caused by mesh implants, said: “We already know mesh procedures are too risky. According to these experts, they are even riskier when the ingredients have been sourced in China.
“Boston Scientific mesh should be removed from our hospitals.”
MSP Neil Findlay said: “Serious allegations have been made yet again regarding the knowing use of mesh which appears to erode after just a few months.
“I raised concerns about counterfeit mesh allegations in September 2016 and the Cabinet Secretary for Health, the medical watchdog the Medicines Healthcare Regulatory Agency (MHRA) and Police Scotland showed little interest in the evidence.”
After their original supplier stopped selling the petrochemical by-product for human use, BSc, which makes mesh implants to treat bladder problems and pelvic organ prolapse, found a new supplier in China, buying enough raw material to last 30 years. The company have repeatedly denied allegations their Chinese-sourced resin is counterfeit.
Scottish Conservative MSP Jackson Carlaw said: “Shona Robison was warned in 2016. Her response then was complacent and to hide behind assurances from the discredited MHRA and, unbelievably, from the company itself.”
Former Health Secretary Alex Neil said: “What the experts on that programme told us was chilling.”
The politician has cross-party support over his call for Scotland to stage an international conference on the scandal which has seen pay-outs in the US of more than £3 billion and around 100,000 legal cases.
Boston Scientific, which faces almost 48,000 US court cases, was ordered to pay one woman, Martha Salazar, £60 million in Delaware in 2015, later capped by Texas law, over their Obtryx implant which was used in Scottish hospitals.
BSc said allegations regarding counterfeit material were false and irresponsible.
The firm said: “These allegations have been reviewed by the US and European regulators. Our products meet rigorous internal safety standards as well as International Standards.”
BSc insist its products have undergone extensive testing.
A Scottish Government spokesman said: “Were the MHRA to issue a safety alert in relation to these products, health boards would, of course, be required to act on it.”
The MHRA say there is “no evidence” of counterfeit material or safety issues.
https://www.sundaypost.com/fp/surgeons-and-politicians-call-for-immediate-ban-of-mesh-implants-made-with-chinese-plastic/
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Weak oversight of medical devices jeopardizes patient safety
May 25, 2018 | MyAJC
By Ariel Hart
Pain in her arm and lightheadedness sent Doris Jones to the emergency room at Savannah’s Memorial Health University Medical Center. A scan there soon revealed a shock. A filter placed in her bloodstream years before to catch clots had fractured, and debris was migrating toward her heart.
While the main part of the filter was removed, a broken piece is still lodged in the artery that carries blood to her lungs because doctors couldn’t safely get it out.
Others who received the filter, made by Bard, died after it shifted or broke apart. More than 3,000 other patients, including Jones, claim they were harmed by a device that went on the market without first being tested in clinical trials to make sure it was safe and effective.
It didn’t have to be.
Jones’ lawsuit, being heard this week, is the latest of hundreds of thousands involving medical devices blamed for sickening or killing patients, cases that point to a weak federal oversight system for some sensitive devices.
The cases are so many and so routine that federal courts have funneled many into a special multi-district system to consolidate them. Georgia lawyers, plaintiffs, hospitals, courts and medical device manufacturers — the state is now home to scores of them — are in the thick of many of them.
Claims involving Bard filters are consolidated in Arizona. In Atlanta, hundreds of lawsuits are pending, and more are filed every week, involving a hernia mesh implant that patients say dissolved into the flesh it was meant to support. More than 20,000 cases involving transvaginal mesh for supporting pelvic organs, including mesh made at a Georgia plant, are consolidated in West Virginia.
Around the nation, other cases involve metal hip replacementssuspected of poisoning patients or a gastrointestinal scope linked to the deaths of dozens infected with antibiotic-resistant bacteria.
In the biggest cases alone, more than 45,000 lawsuits are pending against 13 device makers. That’s not counting 100,000 other suits in those cases that have already been settled, dismissed, or otherwise resolved. And still more come in.
The Food and Drug Administration, which regulates medical devices, clears some sensitive ones for marketing to the public after they’ve been tested on animals or machines. Then, FDA tracks reports of deaths, injuries and malfunctions afterward.
The government has recognized that the tracking is flawed: Doctors and other healthcare professionals are not required to report anything; hospitals are required to report but sometimes simply don’t; manufacturers decide if a serious injury or death is related to their devices.
To address the issue, FDA last month announced its latest safety plan. To the disappointment of patient advocates, the agency, bound by law to regulate device makers in the “least burdensome” way, still will not require all potentially risky medical devices to first undergo safety testing in humans.
Instead, the plan proposes a shift to mining data from electronic medical records, which FDA says will allow it to more quickly detect risks and safety issues. With that move, the agency hopes to go from only “passive” surveillance through others’ reporting problems, to adding “active” surveillance.
Industry groups and the FDA say the system helps ensure patients get life-saving devices. They point out that with hundreds of millions of Americans using more than 190,000 medical devices — counting everything from Band-Aids and Q-Tips to surgical equipment, pacemakers and artificial knees — the number of devices with safety issues is small.
“The system for the most part works fairly well,” Dr. Jeffrey Shuren, director of the FDA’s Center for Radiological Devices and Health, told the Atlanta Journal-Constitution, “but that does not discount the importance about being vigilant about addressing safety issues particularly as technologies continue to evolve.”
Diana Zuckerman, a public health researcher and advocate and president of the National Center for Health Research, is skeptical. “The devil’s always in the details,” she said. “The fact that the FDA is now going to change the process — on the one hand it’s terrible so maybe any change is for the better. But the track record over there is not good.”
Other critics say U.S. law and rules struggle to keep up with a medical device market that has morphed in the space of two generations from tongue depressors, sutures and leg braces to high-tech implants.
They point to a tool called a power morcellator, used in gynecological procedures to grind tissue, that was on the market for two decades before FDA recognized the extent of danger it posed in spreading undiagnosed cancer. The agency took action only after a patient dying from cancer launched a publicity campaign connecting the dots, and The Wall Street Journal wrote about the risk.
Duluth woman awarded millions
The lawsuits against Bard are focusing attention again on the issue of medical device safety and the FDA process for getting devices quickly on the market.
Jones’ case is the second from among the thousands of Bard lawsuits chosen by attorneys and the judge for a “bellwether trial” to test legal arguments and how other cases might play out. The first also involved a Georgia plaintiff, Sherr-Una Booker of Duluth. A jury in March awarded her $3.6 million from Bard, including punitive damages, and $400,000 from a doctor. The case is on appeal.
After Booker got a Bard filter in 2007, she visited hospitals repeatedly for debilitating pain. Finally one day in 2010 a doctor at Gwinnett Medical Center showed her scans with a white shape like a needle over part of her chest. “Is that my heart?” she asked.
Posted: 11:26 a.m. Friday, May 25, 2018
Pain in her arm and lightheadedness sent Doris Jones to the emergency room at Savannah’s Memorial Health University Medical Center. A scan there soon revealed a shock. A filter placed in her bloodstream years before to catch clots had fractured, and debris was migrating toward her heart.
While the main part of the filter was removed, a broken piece is still lodged in the artery that carries blood to her lungs because doctors couldn’t safely get it out.+This is the Bard G2 filter, used to help prevent blood clots.
Others who received the filter, made by Bard, died after it shifted or broke apart. More than 3,000 other patients, including Jones, claim they were harmed by a device that went on the market without first being tested in clinical trials to make sure it was safe and effective.
It didn’t have to be.
Jones’ lawsuit, being heard this week, is the latest of hundreds of thousands involving medical devices blamed for sickening or killing patients, cases that point to a weak federal oversight system for some sensitive devices.RelatedWeak oversight of medical devices jeopardizes patient safetyHospital thought it had answer for rural struggles. Now it’s in peril.Still forgiven: Doctors & Sex Abuse — AJC National InvestigationDoctors and the opioid crisis: An AJC National Investigation
The cases are so many and so routine that federal courts have funneled many into a special multi-district system to consolidate them. Georgia lawyers, plaintiffs, hospitals, courts and medical device manufacturers — the state is now home to scores of them — are in the thick of many of them.+SPECIALThis is a Simon Nitinol filter, the first Bard filter and one that was permanent. Later filters that were retrievable were ... Read More
Claims involving Bard filters are consolidated in Arizona. In Atlanta, hundreds of lawsuits are pending, and more are filed every week, involving a hernia mesh implant that patients say dissolved into the flesh it was meant to support. More than 20,000 cases involving transvaginal mesh for supporting pelvic organs, including mesh made at a Georgia plant, are consolidated in West Virginia.
Around the nation, other cases involve metal hip replacementssuspected of poisoning patients or a gastrointestinal scope linked to the deaths of dozens infected with antibiotic-resistant bacteria.
In the biggest cases alone, more than 45,000 lawsuits are pending against 13 device makers. That’s not counting 100,000 other suits in those cases that have already been settled, dismissed, or otherwise resolved. And still more come in.
The Food and Drug Administration, which regulates medical devices, clears some sensitive ones for marketing to the public after they’ve been tested on animals or machines. Then, FDA tracks reports of deaths, injuries and malfunctions afterward.
The government has recognized that the tracking is flawed: Doctors and other healthcare professionals are not required to report anything; hospitals are required to report but sometimes simply don’t; manufacturers decide if a serious injury or death is related to their devices.
To address the issue, FDA last month announced its latest safety plan. To the disappointment of patient advocates, the agency, bound by law to regulate device makers in the “least burdensome” way, still will not require all potentially risky medical devices to first undergo safety testing in humans.
Instead, the plan proposes a shift to mining data from electronic medical records, which FDA says will allow it to more quickly detect risks and safety issues. With that move, the agency hopes to go from only “passive” surveillance through others’ reporting problems, to adding “active” surveillance.
Industry groups and the FDA say the system helps ensure patients get life-saving devices. They point out that with hundreds of millions of Americans using more than 190,000 medical devices — counting everything from Band-Aids and Q-Tips to surgical equipment, pacemakers and artificial knees — the number of devices with safety issues is small.+FDA PHOTODr. Jeff Shuren is director of the Center for Devices and Radiological Health at the Food and Drug Administration.
“The system for the most part works fairly well,” Dr. Jeffrey Shuren, director of the FDA’s Center for Radiological Devices and Health, told the Atlanta Journal-Constitution, “but that does not discount the importance about being vigilant about addressing safety issues particularly as technologies continue to evolve.”
Diana Zuckerman, a public health researcher and advocate and president of the National Center for Health Research, is skeptical. “The devil’s always in the details,” she said. “The fact that the FDA is now going to change the process — on the one hand it’s terrible so maybe any change is for the better. But the track record over there is not good.”
Other critics say U.S. law and rules struggle to keep up with a medical device market that has morphed in the space of two generations from tongue depressors, sutures and leg braces to high-tech implants.
They point to a tool called a power morcellator, used in gynecological procedures to grind tissue, that was on the market for two decades before FDA recognized the extent of danger it posed in spreading undiagnosed cancer. The agency took action only after a patient dying from cancer launched a publicity campaign connecting the dots, and The Wall Street Journal wrote about the risk.
Duluth woman awarded millions
The lawsuits against Bard are focusing attention again on the issue of medical device safety and the FDA process for getting devices quickly on the market.
Jones’ case is the second from among the thousands of Bard lawsuits chosen by attorneys and the judge for a “bellwether trial” to test legal arguments and how other cases might play out. The first also involved a Georgia plaintiff, Sherr-Una Booker of Duluth. A jury in March awarded her $3.6 million from Bard, including punitive damages, and $400,000 from a doctor. The case is on appeal.
After Booker got a Bard filter in 2007, she visited hospitals repeatedly for debilitating pain. Finally one day in 2010 a doctor at Gwinnett Medical Center showed her scans with a white shape like a needle over part of her chest. “Is that my heart?” she asked.+Sherr-una (Sheri) Booker had a Bard filter placed in her bloodstream to catch clots. Afterward, she endured years of pain she ... Read More
It was. She had open heart surgery to remove the filter pieces, but one could not safely be removed and remains lodged in her blood vessel. She will have to have scans the rest of her life to see if it has moved.
She says it’s not about the money. “Ten million dollars wouldn’t have been enough, $20 million wouldn’t have been enough for what they took,” Booker says.
The federal process that allowed the filter to avoid testing for safety in humans prior to going to market is called 510 (k) “clearance.” The mesh, metal hip implants, gastrointestinal scope and power morcellators that are the subjects of lawsuits also were fast-tracked through the clearance process, rather than going through the more rigorous “approval” process.
The FDA offers clearance on devices it deems substantially equivalent to other devices already on the market. Bard showed its filters were substantially equivalent to others it made and received clearance for six over a decade starting in 2002 and 2003.
The first retrievable filter, the Recovery, was shaped differently than others already in use, though it was declared substantially equivalent. Bard did a clinical trial that demonstrated it could be safely retrieved, but that didn’t show the device itself was safe.
Not long after the Recovery hit the market, two people died after the filter shifted in their bodies. Bard also learned of other problems, including the filter breaking apart.
That prompted Bard’s lawyers to commission an internal report. It suggested the filter was more dangerous than most and more study was “urgently warranted.”
As problems piled up, Bard modified the filter, introducing new versions but not recalling the device. Bard says it shared all its data with the FDA, which never suggested a recall, and that the new versions were a natural evolution of the product. For its latest filter version, Bard did a clinical trial for safety.
Atlanta lawyer Richard North, who represents Bard in the federal lawsuits, and company officials say that Bard fully abides by FDA rules and went beyond what is required for most devices, doing copious research to ensure its filters worked well. The company says it informs doctors of the risks, and for some patients who can’t take medication to stop clots, its lifesaving potential is worth it.
“Doctors weigh the risks and benefits with these filters, because they treat a potentially deadly disease, pulmonary embolism,” North said, emphasizing that all companies’ filters are known to have risks.
A spokesman for Bard, Troy Kirkpatrick, stressed the variety of tests the company had done on the filters and continues to do, and echoed that the filters helped tens of thousands of patients over a decade.
“While we understand that some patients required additional interventions or treatment some years after implantation of a filter, it is important to note that the filter helped to protect them from the life-threatening blood clots from which they suffered, and which typically could not be treated with medication,” Kirkpatrick said in a statement.
Speed vs. safety?
The clearance process is only available for devices deemed moderate-to-high risk, or Class II.
Asked why filters which are implanted in a vessel that leads to the heart would not always be in the highest risk class, Stephen Amato, a former medical device executive and now professor and head of regulatory services at Northeastern University, chuckled. “I was wondering that myself,” he said.
Device manufacturers say they submit rigorous new research, sometimes thousands of pages, to the FDA for clearance.
The FDA said in a statement that it determined that the research and user instructions required “would be sufficient to provide a reasonable assurance of safety and effectiveness.”
But the research has limits, and the U.S. Supreme Court has written that the type of federal clearance given to the filter, mesh implants and other medical devices is not in itself evidence of safety or effectiveness.
The medical device industry, led by the advocacy group AdvaMed, lauds the 510(k) process, saying it has “a remarkable thirty year track record of protecting the public health while making safe and effective products available without unnecessary delays.”
The flexibility it provides allows the companies to innovate, the group says; indeed, if anything the FDA needs to approve devices faster.
‘An honor system’
However, beset by critics of the clearance process, the FDA in 2011 asked the Institute of Medicine of the National Academy of Sciences for a study. It concluded the process isn’t intended to evaluate safety and effectiveness and should be replaced.
Several plaintiff’s lawyers told the AJC that although they make a living from its failures, it should be scrapped.
“Put me out of business for the right reason,” said Julia Reed Zaic, one of Jones’ lawyers. The current regulatory system, she said, is “an honor system.”
“I think it’s a tragedy and a travesty that frequently these things get off the market because first people get hurt and then lawyers pursue cases,” echoed Henry Garrard, a lawyer in Athens.
Garrard is co-lead coordinating counsel on seven groups of cases concerning a vaginal mesh that patients have alleged disintegrated in their bodies, poked through tissue walls and caused them harm. The trials are spanning years. One defendant is Bard, which manufactures meshes at a plant in Covington. Another is Ethicon, which also made a hernia mesh being defended in lawsuits here in Atlanta that are headed to trial perhaps next year. Ethicon has a plant in Cornelia.
A spokeswoman for Ethicon said in a statement that safety is its top priority, it abides by FDA rules and meshes have helped millions of patients.
FDA says it is protecting the public, inspecting makers, offering guidance and recalling products. So far this year, FDA has announced nine device recalls.
FDA had warned Bard that the company had misreported some serious injuries and a death as malfunctions. FDA also noted that it has issued several other alerts regarding filters.
Booker, though, believes the system failed, partly because all those times she went to the hospital her doctors didn’t know what to look for. She argued that the company was interested in making money and that informing doctors about the full extent of danger would have cut into its profits.
The consequences remain. “Whenever I do have the chance of going on vacation or spending time with friends or family I always know where the nearest hospital is,” she said.
https://www.myajc.com/news/national-govt--politics/weak-oversight-medical-devices-jeopardizes-patient-safety/TlYLuwslq7fVB5UYSuWxZI/
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GTx Reports Positive Results in Using Enobosarm to Treat Incontinence
May 25, 2018 | Memphis Daily News
By Michael Waddell
Memphis-based biopharmaceutical company GTx Inc. has deep roots in Memphis, with AutoZone founder Pitt Hyde being a primary backer of the company since its inception in 1997. In recent years, GTx’s research into the muscle-building compound enobosarm has shifted from patients with breast and lung cancer to women with stress urinary incontinence.
SUI refers to the unintentional leakage of urine during activities that increase abdominal pressure, such as coughing, sneezing or physical exercise. It is the most common type of incontinence suffered by women, affecting up to 35 percent of adult women.
“SUI is a very, very, very big quality of life issue for women,” said GTx CEO Marc Hanover, who cites current treatment modalities that include everything from noninvasive Kegel exercises to invasive procedures involving a mesh or sling.
“The issue with mesh and slings is that they’ve had safety problems, and, in fact, the medical industry is probably seeing the largest litigation in a decade around these mesh and sling implants,” said Hanover. “So if we’re successful, we would have the only therapeutic treatment available on the marketplace.”
Enobosarm is a nonsteroidal compound that interacts with androgen receptors. In the case of treating SUI, the compound activates the androgen receptors and strengthens the muscle tone of the pelvic floor, helping to address the root cause of SUI.
GTx is currently running a 12-week phase II placebo-controlled study called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder), which looks at the effectiveness of using 3 mg enobosarm to treat postmenopausal women who have SUI. The study includes 493 women at 60 test sites across the U.S.
The company completed a successful pilot study and presented its findings last September.
“In the pilot study. all of the 18 women showed clinically meaningful benefit from the drug,” said GTx vice president, chief legal officer and secretary Henry Doggrell.
Among the results, the company reported all 18 women reduced the number of SUI episodes they experienced each day by at least 50 percent at the end of the 12-week treatment period.
Researchers continued to follow the patients for up to seven months to help determine the long-term results of the treatment. Additional data presented at the American Urological Association annual meeting in recent days showed that of the 17 women who had reached the seven-month mark, all were experiencing fewer leak episodes per day than they had before the treatment.
The company has been researching the drug since the early 2000s and has invested more than $100 million to date in research and development. Enobosarm originally was tested for treating cancer cachexia in small-cell lung cancer patients. While the trials were successful, the company was unable to show the dual required performance in both clinical phase three studies.
“We’ve since learned that in that type of skeletal muscle in cancer cachexia patients, we really need a higher dose to successfully treat those type of patients,” Doggrell said. “We recouped after that and started focusing on this new opportunity because it’s a lower dose, it’s an unmet medical need, and there’s a huge number of women who have this problem. There’s a screaming need for this kind of pharmaceutical.”
GTx expects to report data from the current study sometime in the fourth quarter of this year. If the findings are positive, the company would then meet with the FDA to see what studies are needed for phase III registration process.
Best case, the drug could be on the market and available to patients by 2021 or 2022.
Interestingly, the company’s previous breast cancer study involving enobosarm was considered a success, but other factors led to GTx discontinuing the research.
“The problem is there are so many other hormonal treatments on the market, and breast cancer therapy is going more into a targeted regimen now. There’s just not demand for, or the commercial prospects for, another hormonal therapy,” Doggrell said. “A small company like ours had to choose if we wanted to go down the path of trying to treat probably a lower cost but a much broader market in SUI versus a more targeted and more expensive hormonal therapy for breast cancer in an environment where there are already a lot of other breast cancer treatments available.”
Future research could involve using enobosarm to treat other medical conditions, like urge and fecal incontinence.
“The drug itself clearly builds lean body mass or builds muscle,” Hanover said. “It’s possible that this type of compound can also be beneficial to women who have urge (incontinence). According to key opinion leaders, most will tell you that with women who suffer from stress urinary incontinence, approximately 30 percent of them suffer from fecal incontinence.”
https://www.memphisdailynews.com/news/2018/may/26/gtx-reports-positive-results-in-using-enobosarm-to-treat-incontinence/
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Vaginal implants concern: contact your GP
May 25, 2018 | Isle of Man Today
Women who are worried following the vaginal mesh implant revelations in the UK should contact their GP, says Health Minister David Ashford.
He said no operations to insert a mesh implant had taken place in the Isle of Man since 2013 and that more than 40 women have had a different procedure since then.
In the House of Keys on Tuesday, he was asked where any women who might be affected should go to first.
Mr Ashford said: ’The first point of call should be the general practitioners and from there, if there is an issue identified, obviously the general practitioners will refer the women on.
’There are obviously concerns that have made the news around vaginal mesh, and I think what is important is that we continue to follow and await with interest the report that has been commissioned in the UK.’
An inquiry has been launched in the UK after it was revealed that vaginal mesh implants had resulted in complications for some patients.
Thousands of women have had to undergo surgery to remove the mesh implants.
support
The implant is a small mesh support used to treat urinary incontinence or prolapse occurring after childbirth.
Complications have included severe pain and the mesh perforating organs.
As many as one in 15 women who had the implant have needed to have it removed, at least in part, recent reports have stated.
The issue was raised this week by Martyn Perkins (Garff).
Mr Ashford told him that no mesh implants were used for the repair of vaginal prolapse in the Isle of Man from January 2013 onwards.
’This particular procedure is subject to multi-disciplinary discussion with our tertiary care provider, the Liverpool Women’s Hospital,’ he said.
’We undertake a procedure called transvaginal taping for urinary incontinence using transvaginal tape, which is a mesh-like product.’
A total of 46 such operations had been undertaken at Noble’s Hospital since January 2013.
http://www.iomtoday.co.im/article.cfm?id=40770&headline=Vaginal%20implants%20concern:%20contact%20your%20GP§ionIs=news&searchyear=2018
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Hernia Mesh: An Absolute Health Disaster
May 26, 2018 | The Ring of Fire Network
By Mike Papantonio
The story about surgical mesh that is being implanted in the bodies of thousands of people every day is not a story the corporate media would ever tell you.
In fact, they can’t tell you because their corporate advertisers the people who make this product won’t allow them to do investigative exposés about how dangerous surgical mesh really is. The advertising dollars are just too big for them.
Ring of Fire’s Mike Papantonio and attorney Robert Price discuss this.
Transcript:
Mike Papantonio: We’re about to un-ring a fire on Mike Papantonio here with Robert Price. Robert of course does, you’ve seen him on the show before. He does complex litigation all over the country, mostly with medical devices. So I want to talk to it right now. The story about surgical mesh, this being implanted in the bodies of thousands of people every day, is not a story that corporate media can tell you, because their advertisers won’t let them tell you this story. In fact, they can’t tell you because their advertisers, the people who make this product, not only won’t tell them, won’t allow them to do it, they’ll actually dry up advertising money if they tell stories like this.
So they can’t really do an investigative expose about this. The advertising dollars are just too big. So with me right now is Attorney Robert Price. He’s handling hernia mesh cases, and he’s going to tell us the story that you won’t hear anywhere else. Robert, first of all, has it, hernia mesh, it’s been around forever, we think it’s something that’s fairly innocuous they’re putting in human bodies all over the country. Give me your take on how bad this actually is, this hernia mesh story.
Robert Price: It’s really bad, Mike, especially in the past 10 years or so, because you’re right. Surgical mesh, and polypropylene, which is a plastic based mesh, has been used for decades in the surgical community. But what we’re seeing here is that these manufacturers are now making these, I kind of call them these easy kits for doctors, with these different meshes with these designs. There are experimental designs that they each use to try to jump ahead of one another in this market share race.
Mike Papantonio: In other words, somebody comes in with a hernia operation.
Robert Price: Yeah.
Mike Papantonio: It used to be that you had to have a special surgeon that could do that.
Robert Price: Right.
Mike Papantonio: And so the industry says, “Oh no, we’re going to make something where any doctor can do this. They don’t have to have special training. They don’t have to be a special surgeon. Just give them the kit, and let them go.” Isn’t that kind of what this industry is?
Robert Price: Absolutely correct. If you’ve got a really skilled surgeon, that surgeon doesn’t necessarily need mesh. Or if that surgeon does need to use mesh, it’s a small piece of mesh, or it’s a more complex procedure. So absolutely. It’s this sort of sales mentality, it’s like, “Well, anybody can do this. Here’s this special mesh. It’s easy to use. It’s got this coding, or it’s got this ring, or it’s got this special feature that makes it great.” And the special feature is completely bogus, and it’s unstudied, and it’s causing infections, and all sorts of massive, massive debilitating injuries.
Mike Papantonio: Okay. You saw this same thing. You kind of led the charge on the vaginal mesh. They were putting this mesh inside women’s vaginas, and inside they’re trying to hold up the kidney, and the urinary system. Explain that case, because this is just an extension of that, isn’t it?
Robert Price: Right.
Mike Papantonio: It’s the same garbage they were putting in women’s bodies.
Robert Price: Absolutely.
Mike Papantonio: First of all, it was nothing different than just pure fishing line, that you could buy at a fishing store. Isn’t that kind of what this story developed into?
Robert Price: Right. Absolutely. So some years back, you’ve seen the Kugel Mesh litigation. This was years ago, where lawyers were bringing claims based on this defective ring. Then years went by, and we did the transvaginal mesh litigation, and we started learning about the behavior of these manufacturers, who are the same manufacturers essentially, just the hernia mesh manufacturers. You see a broad spectrum behavior of using mesh that’s not cleared for medical grade use. In fact, some of these manufacturers use polypropylene that actually says on the material sheet, “Do not use this in the human body.”
Mike Papantonio: Yeah, there’s a material data sheet, and the material data sheet shows how the product can be used, or how it should be used. The manufacturers understood because the document said, “Don’t use this to put in a human body.” But they did it anyway.
Robert Price: Exactly. And that’s just one component of the story. The other component of the story is on top of this bad mesh, you have these coatings, these chemicals. One company even uses fish oil. Just all of these things. An idea here is that they go to surgeons and they say, “Use this mesh laparoscopically. It’s real easy to do. You can place it right up against the bowel, and this fish oil coating, or this special chemical coating, is going to help keep it safe from the bowel.”
Mike Papantonio: So what’s the truth of the matter?
Robert Price: The truth is the coating either causes infections, or it just literally just wicks right away, and the mesh actually eats into the bowel causing bowel obstructions, massive surgeries. People even have to live in a colostomy bag because of damages caused by this stuff. All because of this kind of marketing transcendence that we see. Cheap mesh, no studies, slap it out to doctors-
Mike Papantonio: Point out the no studies. How did this get on the market without them actually doing studies on the hernia mesh itself? How did it? It’s out there without studies. That’s what’s so remarkable. It’s actually out there without studies.
Robert Price: … yeah. There are two types of studies you see. So you see the animal studies. Probably half the animal studies I’ve read are the animal studies show, “Oh crap, this stuff is killing these animals. Put those studies aside.” And then the other studies that they think are favorable, they parse out those studies and show those to doctors. No human studies. The only human studies, if you want to say, are the adverse event reports that we see after they’ve been implanted in thousands of people, thanks to our FDA, who doesn’t required studies to be done in the first place, on humans. I know you’re very well familiar with the 510(k) process, right?
Mike Papantonio: Well the 510(k) is where you have a company that says, “We have an item. We have a mesh that’s similar to the one that you want to put in the human body.” And so the FDA says, “Oh sure. Go ahead and do it. Have you done any longterm studies to figure out how humans are affected?” “No, not really, but it’s already out there, so we get to do it too.” Isn’t that kind of how that works?
Robert Price: Absolutely, it’s like you said. A lot of these products that are on the market are based on meshes 10 years ago. What’s not funny, but what is crazy about this stuff, is that when you have these experimental designs, the 510(k) application actually looks like this. It says, “This mesh is just like this mesh, this mesh, this mesh, and this mesh.” Well, say have you ever studied what would happen if you put all these properties together?” “No, it’s just like these meshes.”
Mike Papantonio: And again, the FDA says, “Oh yeah. That sounds like good science.” Here’s the truth of the matter. We don’t spend enough time as patients asking doctors A, “Could you do this without the mesh? Could you actually perform the surgery without the mesh?” The doctor’s going to say, “Probably not” Okay. “So get me the guy who can do this without mesh.” That’s the first thing. The second thing we don’t ask them is, “How much do you know about the studies that were done on this product that you want to put in my body.” All the doctor’s really confronted with is what we call the detail, or that’s the salesperson comes by their office, has cupcakes for them, says, “Doc, we’re so glad you’re buying our product.” They take them out to lunch. They’ll take them on these exorbitant trips, places like Hawaii, and have what they call a seminar, where they talk about their product. It’s just the biggest scam, and unfortunately, patients are too often too afraid to confront the doctor, and ask questions about the pill that they’re taking, or about what’s being put in their body.
https://trofire.com/2018/05/26/hernia-mesh-an-absolute-health-disaster/
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