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Taking a Peek at Transparency – An FDA Pilot Program

Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.
Specifically, FDA is introducing a pilot program that will publish “clinical study reports” – reports prepared by drug sponsors that provide “bottom line information” on both the methods and results of clinical trials.
The pilot program, to begin this month, will involve the posting of portions of clinical trail summaries from the pivotal trials that were submitted by FDA from drug sponsors and will involve the summaries of 9 companies who volunteer the use of their new drug applications and that participation will include a range of therapeutic categories.
One thing not mentioned in the announcement was the issue of complete response letters (CRLs).
For a long time now, many stakeholders have advocated that CRLs, now considered proprietary, be made public in the interests of greater transparency.
Other questions with respect to the program that were not addressed in the announcement were its anticipated length – how long the program will take to have 9 volunteers, and any outline as to how the success of the program will be evaluated and what steps, if successful, will be taken to make the program permanent.
For many stakeholders, as seen in some of the response on Twitter, this initiative is not going far enough and there are critics who feel it needs to be a broader effort, especially with respect to the CRL issue.
One thing, however, that is clear (pun intended) when it comes to transparency is that when you open the door a little, it is pretty hard to close it again.
With the advent of the pilot program, it would seem difficult for FDA to go back unless the evaluation of this pilot is absolutely dismal.
If interested, there was also a panel discussion held yesterday morning by the Johns Hopkins Bloomberg School of Public Health – A Forum on Transparency at the U.S. FDA that included two panels and a keynote from Commissioner Gottlieb.

Growing MDL Alleges Serious Xarelto Gastrointestinal Bleed Incidents

Johnson & Johnson and Bayer HealthCare are facing a growing multidistrict litigation (MDL), consisting of numerous claims alleging serious Xarelto gastrointestinal bleed incidents.
One of the most recent claims comes from a Virginia woman, alleging she had a serious Xarelto gastrointestinal bleed report.
Plaintiff Bertha G. is filing this Xarelto bleeding lawsuit alleging the pharmaceutical companies failed to adequately warn her of the possibility of a Xarelto gastrointestinal bleed incident.
According to the Xarelto bleeding lawsuit, Bertha had been prescribed the new generation anticoagulant for atrial fibrillation.
Manufactured by Boehringer Ingelheim, Pradaxa was the first drug to be released for anticoagulant purposes since warfarin in the 1960s.
If used according to prescription instructions and physician advice, Xarelto is an ideal treatment choice for patients at risk for blood clot attacks.
Bertha opted to file this Xarelto bleeding lawsuit, after discovering the drug’s alleged correlation with uncontrollable internal bleeding incidents.
This single dose feature has allegedly resulted in numerous Xarelto gastrointestinal bleed incidents.
Bertha is filing her Xarelto bleeding lawsuit in MDL No.
2:17-cv-17526, in the U.S. District Court of Eastern Louisiana.

Zimmer Knee Replacement Component Recalled Due to Complications

In March 2015, Zimmer issued a voluntary recall of its Persona tibial plate after it had spent less than three years on the market.
The tibial plate is part of the Zimmer knee replacement system.
A failing tibial plate may appear through X-rays that portray signs of gaps between the knee implant and the bone, which appear as radiolucent lines.
The Zimmer Persona Trabecular Metal tibial plate is a component of the total knee replacement system.
In February 2015, Zimmer announced its voluntary recall due to it receiving numerous complaints of Zimmer knee replacement issues.The recall impacted more than 12,000 Zimmer knee replacement components.
There were two main issues surrounding the Zimmer knee replacement component, namely loosening and radiolucent lines.
Zimmer’s voluntary recall of its knee replacement component was due in part to reports that the tibial plate came loose from where it was attached.
Revision surgery from those who underwent a total knee arthroplasty with the Zimmer knee replacement component was the most prevalent issue resulting from the loosening of the device.
The second issue with the component of the Zimmer knee replacement system included radiolucent lines.
Some of these reasons included: persistent pain, loosening of the device, lack of ingrowth, component failure, loss of fixation, globally tight knee, instability, fracture, and patella tracking issues.

Man Files Lawsuit Over Failed Atrium ProLite Hernia Mesh Symptoms

A man suffering hernia mesh symptoms has filed a lawsuit against Atrium Medical Corp., makers of Atrium ProLite hernia mesh.
Plaintiff Joseph S. claims he suffered hernia mesh symptoms because his ProLite mesh was defective and caused him to suffer a painful revision surgery and permanent injuries.
Atrium marketed ProLite hernia mesh as being of similar design to its competitors, including Davol/Bard mesh, Ethicon Prolene mesh, Covidien Surgipro mesh and Covidien Parietex mesh, all of which have subsequently been involved in similar lawsuits regarding their own hernia mesh symptoms that lead to mesh failure and permanent injuries.
Joseph was 42 years old when he underwent surgery for a lower abdominal hernia in 2015.
His doctor reported finding significant adhesions of the mesh and said he “tried to separate the peritoneum from the mesh, but it was clear that there was no way that was going to happen.” The surgeon had to cauterize the mesh from Joseph’s pubic tubercle, which is the bone that leads to the pubic area from the spine.
He remains unable to work because of these hernia mesh symptoms, he claims.
Joseph maintains that if he and his doctor had known the risks of adhesion and tack failure in Atrium’s ProLite mesh, he never would have accepted the allegedly defective product.
In addition, Joseph claims, Atrium should have been aware that polypropylene is prohibited from being permanently implanted in the human body.
The hernia mesh symptoms lawsuit further alleges that Atrium should have known the polypropylene material would cause an “immune reaction that results from such material, and causes adverse reactions and injuries, including adhesions.” Atrium also stands accused of failing to appropriately study the mesh’s propensity to shrink or contract once implanted in the human body, which can cause surrounding tissue to produce scar tissue that results in injuries.
4:17-cv-00160-JHM-HBB in the U.S. District Court for the Western District of Kentucky, Owensboro Division.

Complications from Essure Can Lead to Debilitating Pain, Hysterectomy

Thousands of women suffer complications from Essure, a permanent, non-surgical form of birth control, originally created by a small pharmaceutical company called Conceptus before Bayer Healthcare bought the rights to the product.
One metal coil is inserted into each fallopian tube where it is supposed to induce scar tissue that will block the tube completely in about three months.
Other complications from Essure may stem from the plastic coating, which consists of PET fibers, a popular plasticizer found in many commercial products due to the material’s ability to resist stains and water.
These PET fibers can break down when exposed to the heat created by the human body.
Research shows that complications from Essure also include fibers breaking down and emitting antimony, a semi-metallic chemical element known to be toxic when topically applied to the skin.
The human body is at least 98.6 degrees.
Complications from Essure can Lead to Hysterectomy Because Essure is meant to be a permanent form of birth control that instigates scar tissue formation, the process of removing the coils often involves a hysterectomy to remove the entire fallopian tubes.
Women who chose to receive Essure usually were sold on the fact there was no down time with the procedure, which could be performed in their doctor’s office.
Women often suffer from multiple complications from Essure that can be debilitating for years.
Women who say they confirmed with their doctor after three months that their fallopian tubes were completely sealed went on to suffer ectopic pregnancies or miscarriages.

Weekly Roundup 1.12.18

As we ease into the new year cycle, 2018 is still waking up.
Many of FDA’s web pages are not yet updated to reflect that the new year even exists.
The weather is erratic, with low low temperatures one day and rather high a few days later.
The flu season is flourishing.
Comfort food is a good idea.
But if you are not cold and not hot and not sick, here are a few of the things that were of interest this week.
FDA Takes Action on Cough and Cold Meds with Opioids – In another in a growing list of actions taken by FDA to address some aspect of the opioid epidemic, the agency announced this week that it was moving to require safety label changes to prescription cough and cold opioid medicines containing codiene or hydrocodone so that (1) they be labeled only for use in adults aged 18 years and older and (2) have additional safety information for adult use, including an expanded Boxed Warning.
AdComm Votes on Testosterone Replacement Therapies – The Bone, Reproductive and Urologic Drugs Advisory Committee met for two days this week to consider NDAs for two testosterone replacement therapies.
Neither got an approval recommendation from the committee with the first drug Jatenzo getting a nearly split 9 Yes/10 No vote and the following day Tlando seeing a 6 Yes/3 NO vote against approval.
AdComm Votes for NCFB Treatment – In a separate meeting of the Antimicrobial Drugs Advisory Committee there was evaluation of another compound, this one to treat Non-Cystic Fibrosis Bronchiectasis.

Attune Knee Lawsuit Alleges Premature Knee Implant Failure

A new Attune knee lawsuit has been filed over allegations of premature knee implant failure.
The Attune knee lawsuit was filed by plaintiff Cynthia B. against DePuy Orthopedics and Johnson and Johnson, the developers, manufacturers, distributors, and promoters of the Attune knee prosthetic unit.
She claims this prosthetic was defective and consequently failed within a three-year period on her right side.
She had the implant removed in a painful and risky revision surgery on July 17, 2017.
After enduring the pain and suffering and associated risks, Cynthia decided to initiate this Attune knee lawsuit.
This clearance was given under the 510(k) review process, which allows new medical devices to skip much of the evaluation usually required if the devices are “substantially equivalent” to other devices already on the market.
DePuy Orthopedics launch promotions touted the Attune knee system as superior because of the S-curve design of the femoral component.
This feature was supposed to allow for greater flexibility between extension and flexion.
According to this Attune knee lawsuit, the Manufacturer and User Device Experience database (MAUDE), which tracks reports given to the FDA on devices, has accumulated 1,400 reports of prosthetic failures related to the Attune knee system.
The Attune Knee Lawsuit is Case No.

Advisory Committee Activity for 2017

And in fact, looking back over 2017, AdComms did take on a slightly different complexion from the previous year.
Total Meetings – In 2016 there were 22 meetings by committees that involved votes to consider new drug applications.
However, one of those meetings ended up being withdrawn by the company and one of them was withdrawn by FDA (the agency thereafter approved the product without the meeting being held), meaning that there were 21 actual votes for the year.
In 2016 there were 4 joint meetings of committees and in 2017 there were 5 – in all circumstances these were joint meetings with the Drug Safety and Risk Management Advisory Committee (the other common joint meeting is between the Nonprescription Drugs Advisory Committee with a second committee that may have subject matter focus over the RX version of the drug).
Votes Up and Down – Of the 2016 meetings, 19 (86 percent) had votes that recommended approval and just 3 had votes that did not.
Of the 21 meetings where votes were taken to recommend approval or not, the committees voted in favor of an approval recommendation 15 times (72 percent) and voted against a recommendation of approval 6 times.
Disagreements between AdComms and FDA – Frequently people have a question as to how often there is discordance between the recommendation of an AdComm and the FDA.
In 2016 there were 3 instances where the panels recommended approval, but FDA did not approve the products – at least immediately, and there was 1 situation where the panel did not recommend approval, but FDA went ahead and approved the product anyway, a rate that was above the norm.
There was also only 1 example where an AdComm did not recommend (actually an evenly split vote) approval, but FDA did approve, a rate that was below the norm.
This past year marked a banner year for approvals.

Lawsuits Blame Diabetes Drug Invokana for Amputations

People who say they had to undergo amputations below the knee after taking the Type 2 diabetes drug Invokana are filing lawsuits against Johnson & Johnson’s Janssen Pharmaceuticals.
Injured parties have filed Invokana lawsuits in state court in New Jersey, where Johnson & Johnson is based, and in federal multidistrict litigation, which is also being managed in New Jersey.
Multidistrict litigation (MDL) is a way for federal courts to streamline the management of large numbers of lawsuits filed around the country involving the same issues.
In the case of Invokana, 952 complaints alleging various injuries were pending as of Dec. 18, 2017, according to court records.
A federal court panel created the Invokana MDL on Dec. 7, 2016.
Tennessee Woman Loses Toe The most recent federal lawsuit linking Invokana to amputations involves Gadsden, Tenn., resident Bonnie Hamm, who filed a lawsuit Dec. 26, 2017.
Hamm began using Invokana after it was prescribed to treat her diabetes in May 2016, according to the complaint.
The lawsuit accuses Janssen of failing to adequately warn patients and doctors about the risks of taking the drug and the monitoring required to ensure patient safety.
Iowa and Alabama Men Sue in State Court Lawyers filed two lawsuits in New Jersey Superior Court in Middlesex County on behalf of patients who underwent amputations after taking Invokana, according to a Jan. 2 news release.
In addition, attorneys filed four Invokana amputation lawsuits in federal court on Oct. 20, 2017.

Court Reverses $5.6M Risperdal Death Case Verdict

A state appeals court in California overturned a $5.6 million Risperdal verdict against Johnson & Johnson’s Janssen subsidiary, which is accused of causing the death of a young man during the drug’s clinical trials.
BC432264 — Augustine Liu, II died in 2009 after enrolling in a Risperdal clinical trial and suffering heart problems.
His parents later filed a lawsuit against Liu’s psychiatrist and J&J.
Although the appeals court overturned the verdict, the case highlights the importance of safety during clinical trials and the severe side effects of Risperdal, a drug used to treat mental disorders including schizophrenia, bipolar disorder.
Lawsuit Accused J&J of Negligence In the original lawsuit, Liu’s parents accused J&J’s employees of ignoring abnormalities in his heart, which, the lawsuit says, led to his death.
According to studies, Risperdal and other atypical antipsychotics can cause side effects such as irregular heart rhythms that may lead to heart attack and death.
Liu’s lawsuit stated that J&J’s employees in the clinical trial ignored blood work and heart tests that showed the 25-year-old had a prior heart attack and suffered from possible abnormal heart rhythms.
After receiving his first injection of Risperdal on Feb. 23, 2009, Liu’s test results revealed worsening heart problems.
Lui’s attorneys argued that J&J should have excluded him from the study based on the evidence of heart problems.
J&J Faces Millions in Risperdal Verdicts and Settlements While California’s appeals court overturned Liu’s verdict, J&J still faces ongoing litigation over claims that Risperdal caused young boys and men to grow female breasts — a condition called gynecomastia.