4/27/2017 ACTION: Johnson & Johnson Annual Shareholders Meeting

Who: Device and Drug Harmed Patients/Advocates:  

Pelvic Surgical Mesh, Breast Implants, Hernia Mesh, Power Morcellators, Hip Replacements  Risperdal, Levaquin,  Motrin, etc.

What: MAM Rally & Patient Safety Peaceful Protest with Award-winning Documentary Filmmaker
When:  Thursday, April 27th 2017, 8 am - 1pm EDT
Where:

State Theatre
15 Livingston Avenue
New Brunswick, NJ 08901

J&J Headquarters
1 Johnson and Johnson Plaza (Intersection of Albany & Neilson)
New Brunswick, NJ  08901-1241

RSVP to organizers on the official Facebook Event Page:  https://www.facebook.com/events/1190677214382644/

Meet & Greet
Wednesday Evening, April 26th, 6pm
Carrabba's Italian Grill
335 NJ-18, East Brunswick, NJ 08816
(732) 432-8054

Video of 2014 action:  

https://vimeo.com/92990332

What the shareholders are told: http://www.investor.jnj.com/events.cfm

$1Billion verdict J&J DePuy Pinnacle metal-on-metal hips (December 2016)
https://www.law360.com/articles/867121/3rd-j-j-hip-implant-bellwether-delivers-1b-verdict
$2 Billion settlement - Risperdal (2013)
http://articles.latimes.com/2013/nov/04/science/la-sci-drugmaker-settlement-antipsychotic-20131104
Levaquin antibiotic  http://www.fiercepharma.com/regulatory/levaquin-users-slap-j-j-800m-rico-suit-claiming-pharma-giant-hid-serious-side-effects
https://www.drugwatch.com/manufacturer/johnson-and-johnson/

Research must be carried on, innovative programs developed and mistakes paid for. 
The Johnson & Johnson credo

Hotel:  
Holiday Inn Express & Suites Tower Center New Brunswick
4 Tower Center Blvd
East Brunswick, New Jersey 08816
800-315-2621 or 732.247.6800
www.ihg.com/holidayinnexpress/hotels/us/en/east-brunswick/ebknj/hoteldetail

$99 discount rate - code: MAM(complimentary breakfast is included)

Airport:  
Newark (airport code EWR)
20 miles from hotel
or
LGA(LaGuardia airport) via hired car to NYC Penn Station/Manhattan to NJTransit/New Brunswick Station $14/1 hour

Contributions:
Encourage your supporters to participate financially:
GoFundMe to help with expenses and to help pay for hotel costs for those in need.  
https://www.gofundme.com/jj-mesh-rally-fund

Surgical mesh survey shows 'horrific' patient outcomes.

Surgical mesh survey shows 'horrific' effects

By Simon Wong

Wednesday 31 Aug 2016 3:03 p.m.

The severe after effects of surgical mesh implants have been quantified for the first time in a survey, which suggests many problems could go unreported.

Lobby group Mesh Down Under is pushing for change in the way surgeons use the product and is raising awareness for the problems it can cause.

Fifty-seven of the group's 197 members responded to the survey, in which 87 percent said they weren't warned about the potential risks and 91 percent weren't offered an alternative treatment.

The mesh is used in a number of surgeries, including for pelvic organ prolapse and stress urinary incontinence.

The survey's results appear contrary to Medsafe's advice to DHBs and private hospitals last year, which said clinicians should consider research and talk to patients about treatment options, including the risks and benefits "in clear and simple terms".

Mesh Down Under survey results:

• 70 percent experienced painful sex since surgery
• 20 percent of cases reported to Medsafe
• 80 percent needed one or more follow-up surgeries
• 44 percent had their condition return after surgery
• Of those who reported complications, 75 percent said GP didn't know about the adverse effects

Group spokesperson and registered nurse Patricia Sullivan said Medsafe had touted the benefits of mesh outweighing the risks.

"The risks are so horrific, that if people knew the risks, really knew how life-changing they are, they wouldn't do it.

"When it goes bad, it goes really bad," she says.

Problems with the mesh can sometimes take years to be felt, with 45 percent of respondents saying they'd had complications between five and nine years after surgery.

Ms Sullivan, who had an implant in 2008, says that makes it difficult for medical professionals to diagnose, with surgeons reluctant to re-operate.

"It took me four years for it to be diagnosed, and in those four years I saw six different specialists."

Ms Sullivan says the implants are faulty products, and pointed to three US states - Kentucky, Washington and California - suing Johnson & Johnson after they allegedly "concealed and misrepresented" the risk of surgical mesh.

Last week, the Government said it would consider creating a registry for the use of surgical mesh along with other recommendations from the health select committee.

The committee recommended:

• Investigate options for establishing a centralised mesh registry, consistent with international recording of mesh complications;
• Review best practice around informed consent for surgical mesh patients;
• Encourage health providers to ensure coding information is consistent so that patients with mesh complications can be identified and monitored;
• Encourage utilisation of the adverse events reporting system;
• Endorse ongoing education for surgeons around the use of mesh and mesh removal;
• Consider expanding Medsafe's role to assess quality and safety of medical devices.

Fellow campaigners Charlotte Korte and Carmel Berry say the recommendations don't go far enough and backed Labour health spokesperson Annette King's call for a full inquiry.

New Zealand First health spokesperson Barbara Stewart says the survey's numbers are concerning and congratulated those who had been "working tirelessly" on the issue.

She urged the Government to adopt all of the committee's recommendations.

"New Zealanders have suffered for long enough. The Government must show leadership," she says.

ACC Minister Nikki Kaye says cost of surgical mesh claims in the 10 years to May 2015 was $7,752,000.

Ms Sullivan says the survey could be considered a pilot study into the effects of surgical mesh because data hasn't been collected by other authorities, including Medsafe.

Newshub.

http://bit.ly/2bNPnfs

http://bit.ly/2bNPnfs

@wimon_song 

simonwong@mediaworks.co.nz

Wellington, NZ

@NewshubNZ

27 Fatalities of Implanted Device: C.R. Bard CEO Sells $7M Shares

Medical Device to Prevent Blood Clots Associated With 27 Fatalities (Video link 4:37)

by TIM SANDLER, STACEY NAGGIAR and STEPHANIE GOSK

September 3, 2015

Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.

At least 27 deaths have been associated with the Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, an NBC News investigation has found.

Government data shows approximately 300 other non-fatal problems have also been reported with the Recovery, which is one of thousands of medical products sold by C.R. Bard.

Dodi Froehlich, 45, got hers after severe injuries in a 2004 car accident put her at high risk for clots. The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her.

Four months after it was implanted, she developed a severe headache and passed out.

"In that two seconds of being in the ambulance, I started flat-lining," Froehlich told NBC News.

Testing revealed a piece of the filter had broken off and pierced her heart, and she had to have emergency open-heart surgery.

"My family was notified," she said. "The priest was brought in."

Surgeons were able to remove the broken piece during emergency open-heart surgery and save Froelich's life, but not all Recovery recipients have been so lucky.

Gloria Adams, then 55, needed a filter after a brain aneurysm in 2004. Her son Kevin Keech says "everything was fine" when she was discharged from the hospital — but a week later, she was dead.

An autopsy showed that instead of the filter stopping a clot, a clot pushed the entire device into her heart, puncturing it.

"I didn't get many answers at that point," her son said.

After the problems with the Recovery began, Bard hired public-relations giant Hill and Knowlton. The firm circulated a crisis management plan to Bard management, warning that "unfavorable press" could damage stock prices and ruin reputations. The company also retained an outside doctor to conduct a confidential study, which was obtained by NBC News.

The consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.

"Further investigation...is urgently warranted," the doctor wrote.

But even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Each year, about a quarter of a million blood clot filters are implanted in patients who can't tolerate blood thinners, most without incident. Eleven companies sell them in the U.S., but Bard's Recovery filter stood out early as a risky device.

Bard officials declined NBC News' requests for interviews but in a statement said all its filters have been "appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate "significant benefits to patients."

Getting FDA clearance took more than one attempt. After the agency rejected one application for the Recovery, Bard, in 2002, recruited Kay Fuller, a veteran regulatory specialist, to help try again.

In an exclusive interview with NBC News, Fuller raised questions about how Bard handled that application.

She says the company did not give her important safety performance test results and that a small clinical trial raised red flags.

"I was pretty concerned there were going to be problems with this product," she said.

However, when she voiced those concerns, she said, the message she got was that she would be removed from the team if she continued to pursue the matter.

"I was shocked," she said.

Read Part Two of NBC News' Investigation tomorrow: Did C.R. Bard forge Kay Fuller's signature on a key document submitted to the FDA?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

@NBCNightlyNews

@StephGosk

http://www.dakotafinancialnews.com/insider-selling-timothy-m-ring-sells-40000-shares-of-c-r-bard-stock-bcr/405340/

Insider Selling: Timothy M. Ring Sells 40,000 Shares of C R Bard Stock (BCR)

September 3rd, 2015 - 

C R Bard (NYSE:BCR) CEO Timothy M. Ring sold 40,000 shares of the stock in a transaction that occurred on Monday, August 31st. The stock was sold at an average price of $195.17, for a total value of $7,806,800.00. Following the transaction, the chief executive officer now owns 119,694 shares in the company, valued at approximately $23,360,677.98. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.

Several equities research analysts recently commented on BCR shares. Zacks raised C R Bard from a “hold” rating to a “buy” rating and set a $194.00 target price for the company in a research note on Wednesday, June 24th. Goldman Sachs raised C R Bard from a “neutral” rating to a “buy” rating and lifted their price objective for the company from $193.00 to $220.00 in a research note on Thursday, August 27th. TheStreet cut C R Bard from a “strong-buy” rating to a “hold” rating in a report on Monday, August 24th. Brean Capital reiterated a “hold” rating on shares of C R Bard in a research note on Thursday, July 23rd. Finally, KeyBanc began coverage on shares of C R Bard in a research note on Thursday, August 27th. They issued a “sector weight” rating for the company. Seven investment analysts have rated the stock with a hold rating and four have issued a buy rating to the company. C R Bard presently has a consensus rating of “Hold” and a consensus target price of $193.38.

Shares of C R Bard (NYSE:BCR) traded up 2.30% during mid-day trading on Wednesday, hitting $191.86. The company had a trading volume of 512,486 shares. The stock’s 50-day moving average is $191.45 and its 200-day moving average is $176.17. The stock has a market cap of $14.24 billion and a price-to-earnings ratio of 42.34. C R Bard has a 52-week low of $141.49 and a 52-week high of $202.47.

C R Bard (NYSE:BCR) last announced its earnings results on Thursday, July 23rd. The company reported $2.27 earnings per share (EPS) for the quarter, topping the Zacks’ consensus estimate of $2.18 by $0.09. During the same period in the previous year, the firm posted $2.06 earnings per share. The business had revenue of $859.80 million for the quarter, compared to analysts’ expectations of $836.18 million. The firm’s revenue was up 4.0% compared to the same quarter last year. Equities analysts forecast that C R Bard will post $9.08 earnings per share for the current year.

Patient outcome research needed for heart implant devices!

Big Changes to Heart Devices OK'dWithout New Data

Published: Jan 22, 2014

By Todd Neale, Senior Staff Writer, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania

Action Points

         Many cardiac implantable electronic device models currently used by clinicians were approved via the pre-market approval supplement process, not as original pre-market approvals.

         Most new device models are deemed safe and effective without requiring new clinical data, indicating the importance of post-approval surveillance.

Many of the high-risk implantable cardiac devices in use today were approved through a supplement pathway that does not require new clinical data on the safety and effectiveness of changes made to the products since their original approval, a review of an agency database showed.

From 1979 through 2012, 77 original pre-market approval (PMA) applications -- which required the manufacturers to provide clinical data on the safety and effectiveness of the devices -- were cleared by the FDA, according to Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

During that same time, however, those original PMAs were subject to 5,829 approved supplement applications, which covered everything from relatively minor changes to labeling, materials, or packaging to substantial design changes, often without the need for additional clinical data, they reported in the Jan. 22/29 issue of the Journal of the American Medical Association.

"It behooves physicians and patients when they're considering a device to understand not only that the device has been FDA approved but to understand the process through which the device was FDA approved and any data that exist about the device," Kesselheim said in an interview.

The FDA uses the PMA process to evaluate new high-risk medical devices, which include pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. But changes to previously approved devices can be introduced using the supplements.

"The benefits [of the supplement pathway] are the more rapid approval and clinical use of new technology," commented Michael Rinaldi, MD, director of clinical research at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, N.C., who was not involved in the study. "Requiring a large randomized trial for every proposed iterative device improvement would slow and potentially stop needed improvements in technology."

But it also means that many of the devices clinicians are implanting into patients currently -- which may be substantially different from the device included in the original PMA after numerous small changes -- have not been subject to rigorous clinical testing.

Kesselheim and colleagues noted that the Medtronic Sprint Fidelis and St. Jude Medical Riata ICD leads -- which were recalled in 2007 and 2011, respectively -- were both approved through the supplemental process and were never tested in clinical studies before entering the market.

"The pitfalls [of the supplement pathway] are that it is difficult to know the impact of even seemingly small changes in actual use without clinical data. And as there are usually multiple supplements, many small changes add up," Rita Redberg, MD, of the University of California San Francisco, who co-authored an accompanying editorial, told MedPage Today. "As we learned from the Fidelis and Riata leads, what seems like a good idea may not turn out that way when implanted in patients."

The Study

During the study period, there were original PMAs for 46 pacemakers, 19 ICDs, and 12 CRT devices, according to the FDA's PMA database. But each device was subject to a median of 50 supplements (ranging from 0 to 306) by the end of 2012.

The median period of activity for a PMA -- the time from the original approval of the device to the most recent approved supplement -- was 15 years. And more than three-quarters (79%) of the original PMAs approved during the study had at least one supplement approved in the most recent year of the study period.

"The long active life of ... PMA approvals suggests that minor design changes may accumulate over time and in some cases may add up to substantial changes from the device approved in the original PMA application," the authors wrote.

"To guard against this outcome, the FDA could mandate an expert panel review of each PMA every 5 to 7 years in which it is active to evaluate the extent to which clinical data from older models still apply to newer ones," they suggested. "Another possibility would be more widespread implementation of rigorous post-market studies to evaluate device performance once approved for clinical use."

Risk-Benefit Balance of Supplements

The fact that most supplements are approved without additional clinical testing is not necessarily a bad thing, Kesselheim and colleagues wrote, because preclinical testing can be superior in some cases.

"For example, mechanical testing of ICD leads can simulate years of clinical conditions relatively quickly, and animal studies may allow for repeated induction of arrhythmias that would be impossible in a human model," they wrote. "Thus, our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness."

But, preclinical testing may not uncover all of the problems that will occur when the implants are placed in the human body, Redberg and co-author Steven Goodman, MD, PhD, of Stanford University in Stanford, Calif., noted in their editorial.

"The tricky part is that it is hard to know in advance when changes approved by supplements without clinical data will turn out to be dangerous or even life-threatening in clinical use," Redberg told MedPage Today. "This is a particular issue for implanted devices, as they can be risky to remove. One cannot recall implanted medical devices when they are defective, as one does for a car."

The current study does not provide a way to assess the relative risks and benefits of using the supplement pathway to get modified devices approved for use, according to Rinaldi.

"There are risks in over-regulation by slowing useful and clinically beneficial innovation. There are also risks in under-regulation by not detecting well-intended but ultimately harmful innovation," he said. "While the ICD lead recalls were highly visible and clearly harmful to patients, the real question is: how often did rapid approval lead to harm and how often did it lead to benefit and what was the overall magnitude of the harm and benefit?"

He said that FDA is in a difficult position regarding device approvals.

"If they are too conservative, they will slow the pace of improved care and put the U.S. even farther behind other industrialized countries in terms of access to new technology, and they will be criticized by advocates for rapid innovation," he said. "If they are too liberal, then they are at risk for missing problems and will be pilloried by patient safety advocacy groups."

Rinaldi said he thinks the agency does a reasonable job, pointing out that "for all the device changes reported in the article, very few of them have resulted in harm. While the ICD lead problems are used to illustrate the downside of less strict regulation, no examples are provided of how patients were helped by iterative advances through this process or harmed by lack of access to improvements."

Kesselheim is supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research, a Greenwall Faculty Scholarship in Bioethics, and a career development award from the Agency for Healthcare Research and Quality. One of his co-authors was supported by a Harvard Medical School fellowship. Another is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research and is supported by a career development award from the Harvard Catalyst Clinical and Translational Research Center and a Paul B. Beeson career development award in aging.

Kesselheim and one of his co-authors reported previously publishing research funded by the FDA on comparative medical device regulation. That co-author reported serving as a consultant to the FDA's Circulatory Systems Advisory Panel.

Redberg reported being a member of the FDA's Circulatory System Devices Panel and a member of the California Technology Assessment Forum. She is the editor of JAMA Internal Medicine. Goodman did not report any conflicts of interest.

From the American Heart Association:

         Science News: ESC 2013: Intervention & Devices

Primary source: Journal of the American Medical Association
Source reference: Rome B, et al "FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012" JAMA 2014; 311: 385-391.

Additional source: Journal of the American Medical Association
Source reference:Goodman S, Redberg R "Opening the FDA black box" JAMA 2014; 311: 361-363.

http://bit.ly/KMAGKH

BBC Radio exposes the lack of regulation of implanted medical devices!

Face the Facts!: Tried and Tested?

New drugs undergo strict testing. New medical devices often don't have to. But with thousands of women damaged by vaginal surgery, surgeons and patients are calling for tougher safety rules. It's the latest in a series of controversies around new medical devices stretching back years - including metal-on-metal artificial hip joints and PIP breast implants.

Concerned surgeons say a compulsory register for all devices is long overdue, so we can track success and failure. But might insisting on too rigorous a testing regime have the unintended consequence of stifling medical innovation and making it too expensive for all but the biggest companies?

Presenter: John Waite Producer: Paul Waters Editor: Andrew Smith.

• Broadcast onBBC Radio 4, 12:30PM Wed, 22 Jan 2014
• Available until12:00AM Thu, 1 Jan 2099
• First broadcastBBC Radio 4, 12:30PM Wed, 22 Jan 2014
  http://www.bbc.co.uk/iplayer/episode/b03q9dc8/Face_the_Facts_Tried_and_Tested/

Katie Couric: apply to talk about SUI and OAB treatments

FiDA highlight

 Women’s Health: Ask The Doctor  

http://katiecouric.com/be-on-the-show/womens-health-ask-the-doctor/

Are you a woman in your 30’s or 40’s who suffers from Overactive Bladder (OAB)? Has it affected your daily life? If you have questions, our “Katie” doctor could offer you solutions. If you live in the tri-state area and are willing to share your personal story, you could be featured on an upcoming episode of “Katie.”

 Last Name

Email

Phone Number

Street Address

City

State

ZIP/Postal Code

Country

Age

Facebook profile

Twitter handle

Tell us your story

Add a photo link (ex TwitPic, Instagram, Flickr)

Add a YouTube video link

Subscribe to our newsletter(required)

By clicking this box you accept and agree to our terms of use† and our privacy policy‡. You also consent to share your information with KAC Productions LLC.(required)

Apply for this Patient Advocate Scholarship by November 1

 Apply for a scholarship to the 2013Lown Conference!    FiDA highlight

We are excited to announce that we have scholarship funding to help bring  medical students, residents, nurses and nursing students, community organizers, civic leaders, patients, and patient advocates to the 2013 Lown Conference - apply now! 

The conference is happening on Boston on December 3rd and 4th. You should read the full program, but here’s a refresher on the major goals of this year’s conference:

•               Creating a new conversation among clinicians, patients, and civil society about the purpose of medicine and the health care system

•               Understanding overuse as a moral and spiritual problem

•               Recognizing that a better world is possible

•               Envisioning health and health care 25 years from now.

We will also have working group meetings on December 5, the day after the conference, covering Medical Education, Public Engagement, International Collaboration, the Choosing Wisely campaign, and Setting the Research Agenda. If you are interested in participating in one of these working groups, please email us for more information at info@lowninstitute.org, and watch this blog for more details on the different working group agendas!

If all of that sounds exciting and informative, but you’re unsure of how to pay for travel, this is your opportunity! The scholarships will provide reimbursement (up to $1200) to cover travel and lodging for the conference. We are committed to using these scholarships to bring a wide range of voices and perspectives to the conference, and we know it will be a better event with representation from all groups concerned with reducing overuse in medicine.

If you’re interested, apply here by 5pm Eastern time on November 1, 2013. (That’s only two weeks from tomorrow!) We are only able to offer a limited number of scholarships, but will accommodate as many applicants as possible. We will notify recipients by email.  

And finally, please share this information with your colleagues, students, and anyone else who you think would benefit from participation in what promises to be an incredible conference!