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.

Monday, May 20, 2013

ProPublica Quantifies & Personalizes Hospital Patient Harm: Interactive

Press this link and participate in this interactive session on hospital hazards.


The Story Behind Our Hospital Interactive



.
Here at ProPublica, we love to find new ways to tell stories. We’ve built data-driven news apps, commissioned our own news songs and crafted narratives with a novelist’s touch, all to enrich our investigative reporting.
Your Hospital May Be Hazardous To Your Health,” co-published today with PBS Frontline, is our newest try at innovation. And it had an unusual gestation – as part of a five-day hackathon that brought together teams of journalists, filmmakers, developers and designers to produce interactive stories for the Web.
The piece draws from ongoing reporting about patient safetyby ProPublica reporters Marshall Allen and Olga Pierce. Our collaborators were documentary filmmakers Tom Jennings and Sabrina Shankman and Director of Development Sam Bailey, all with Frontline, and a team from Ocupop, a web design and development group based in Milwaukee, Wisc.
The hackathon – “Tribeca Hacks: Storytelling Innovation Lab” – is a project of the Tribeca Film Institute and Mozilla that is supported by the Ford Foundation.

Friday, May 17, 2013

Failed Implanted Medical Device 'phased out'


J.&J. Unit Phasing Out All-Metal Hip Devices

The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.
In 2010, the company, DePuy Orthopaedics, recalled an all-metal model known as the Articular Surface Replacement, or A.S.R., because it was failing just a few years after implant. Typically, artificial hips made from materials like plastic and metal last 15 years or more before they wear out and need to be replaced.
But after that recall, the company continued to sell an all-metal version of a popular hip model called the Pinnacle. In doing so, DePuy insisted that the all-metal Pinnacle was safe and performing on par with other hip replacements, a position it reiterated on Thursday.
It is estimated that all-metal replacement hips — in which both the cup and ball of a device are made from metal — once accounted for about one in three hip implants used in the United States. However, the metal components rubbed against each other as a patient moved, creating tiny particles that could damage tissue, muscle and bone.
Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission
In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.
In January, the agency told producers of all-metal hips that any models that were cleared for sale through a regulatory route that did not require premarket clinical testing in patients would have to run such studies to continue selling them.
“DePuy has communicated to the F.D.A. its decision not to pursue” such studies for the device, the company said in its statement.
The company said it was also discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal component used in both the Pinnacle and the Complete will end in August, the company said
.

Thursday, May 16, 2013

FDA Patient Network Town Hall Live Chat May 21

May 21 FDA Patient Network Town Hall


Join a Live Chat

Upcoming Events - ***you must follow the link above and sign up on the FDA webpage****
Tuesday   May 21, 2013 - 
3:00pm to 4:00pm ET 
2:00pm to 3:00pm CT
1:00pm to 2:00pm PT
Join the FDA Office of Health and Constituent Affairs in a live chat with the director of it's patient liaison team, Richard Klein, to discuss the new FDA Patient Network and how patients can engage with the agency.  The live chat will be in the format of a town hall, allowing patients and patient advocates to discuss FDA's various mechanisms for including the patient perspective into regulatory decision-making, and how the new FDA Patient Network will facilitate broader patient engagement.


Wall Street Journal on Surgical Mesh Post-Market Surveillance Study


Updated May 14, 2013, 4:08 p.m. ET

By SHIRLEY S. WANG   Wall Street Journal   FiDA highlight
A new study finds that long-term benefits are limited for many women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.
The surgery, called abdominal sacrocolpopexy, has been the standard treatment for the gynecological condition for more than three decades, but its outcomes rarely have been studied systematically beyond two years. In addition, there isn't agreement among doctors about what constitutes success for the procedure.
In pelvic organ prolapse, the uterus or vaginal walls "drop" after childbirth and sometimes protrude into or out of the vaginal opening. Most women who have had children vaginally have some degree of prolapse but may not notice symptoms, which can include feeling a bulge in the vagina, a delay in urinary stream and difficulty with defecation.
For some 225,000 women a year in the U.S., the symptoms become so problematic that they get surgery.
Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery, are used to prop up or anchor the organs to keep them in place, sometimes with the use of synthetic mesh. A third operation, used only rarely for older women, closes up the vagina.
The new study, published Tuesday in JAMA, the Journal of the American Medical Association, followed the outcome of more than 200 women for an average of seven years after sacrocolpopexy surgery. It is one of the longest follow-ups to date of such patients.
The study showed that many women receive short-term relief from symptoms and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur over time, and more than 60% develop urinary incontinence, sometimes as a result of the surgery itself.
"Surgery for pelvic organ prolapse isn't perfect," said Ingrid Nygaard, first author on the study and a professor of obstetrics and gynecology at the University of Utah School of Medicine. "It is very good at alleviating symptoms and improving quality of life, but the results may not last forever."
For those who had mesh implanted as part of the procedure, some 10% experienced movement of the mesh from its original location, which "may cause problems for years down the road," said Dr. Nygaard.
The use of synthetic mesh in a related pelvic organ prolapse procedure, in which the mesh is inserted through the vagina rather than through the abdomen, is the subject of hundreds of product-liability lawsuits against mesh makers. The suits allege the women were injured when the mesh failed.
Mesh contraction can occur in the vaginal procedure and cause pain, but mesh movement with the abdominal surgery is unlikely to be painful, according to Dr. Nygaard, who has no ties with mesh makers.
Strategies to prevent pelvic organ prolapse center on pelvic-muscle exercises and childbirth through cesarean section. Some studies have shown such exercises to be effective, and one large epidemiological study in Sweden suggested a link between C-sections and lower risk of the condition. But the preventive effect of C-sections hasn't been studied in a randomized trial.


Further reading:

Jane Akre:  Mesh Device News Desk
http://meshmedicaldevicenewsdesk.com/featured-articles/mesh-fails-25-percent-of-time-in-vaginal-prolapse-repair/

 Ingrid Nygaard:
http://healthcare.utah.edu/fad/mddetail.php?physicianID=u0513310
Study Press Release:
http://www.eurekalert.org/pub_releases/2013-05/tjnj-sel050913.php

JAMA study:
http://media.jamanetwork.com/news-item/study-evaluates-long-term-effectiveness-of-surgery-for-pelvic-organ-prolapse/




Monday, April 29, 2013

Bad Ad: Johnson & Johnson tarnished halo selling new 'product': love!

Have the FDA and FCC approved this ad?  
What product is this corporation selling?
Does it have to disclose that it is being sued by thousands of harmed patients?
(Metal on metal hips and surgical mesh.)


This bad ad will be aired:



History does not match JNJ we have today:

Thursday, April 25, 2013

Dick Smothers, bankruptcy and the birth of DTC marketing.

DTC is direct to consumer advertising.  This is an example of a new ad that just began airing.

Q. Is it important to the public to know that Dick Smothers may be conflicted by his personal bankruptcy?
Q. Is it important to the TV watching public to know that the need for Covidien's product is limited to 1-2% of the people who have Barrett's Esophagus and only 10-15% of the people who have acid reflux have Barretts Esophagus?  This is rare, rare, rare!!!!
Q. Where is the FDA in providing guidance to the public on providing truth in DTC ads?  Patient harm comes from interventions that are intrusive, costly and potentially dangerous.
Q. Is this one?

Background video:
Scott Corbett, M.D. | Sarasota Memorial Hospital, Sarasota, FL

Covidien Clinical Trial Investigator  
Dick Smothers surgeon (no financial conflict there!)


Barrett's esophagus is a serious complication of GERD, which stands for gastroesophageal reflux disease. In Barrett's esophagus, normal tissue lining the esophagus -- the tube that carries food from the mouth to the stomach -- changes to tissue that resembles the lining of the intestine. About 10%-15% of people with chronic symptoms of GERD develop Barrett's esophagus.
Barrett's esophagus does not have any specific symptoms. Patients with Barrett's esophagus may have symptoms related to GERD. It does, though, increase the risk of developing esophageal adenocarcinoma, which is a serious, potentially fatal cancer of the esophagus.
Although the risk of this cancer is higher in people with Barrett's esophagus, the disease is still rare. Less than 1% of the people with Barrett's esophagus develop this particular cancer. Nevertheless, if you've been diagnosed with Barrett's esophagus, it's important to have routine examinations of your esophagus. With routine examination, your doctor can discover precancerous and cancer cells early, before they spread and when the disease is easier to treat.

Smothers brother files for bankruptcy
Published: Saturday, February 20, 2010 at 1:00 a.m.
Last Modified: Friday, February 19, 2010 at 10:27 p.m.
SARASOTA - Dick Smothers may be renowned for his humor, but there is nothing funny about his current financial situation.
The 71-year-old comedic actor filed for Chapter 11 bankruptcy protection in Tampa earlier this month, listing $2 million in assets and $2.8 million in debts on homes he and his ex-wife, Denby Smothers, own on Bird Key and Golden Gate Point.
Smothers is the younger brother in a two-man comedy team. The brothers hosted the "Smothers Brothers Comedy Hour" on CBS in the 1960s, and still perform together in concert halls across the country.
Dick Smothers could not be reached for comment. His bankruptcy attorney, John Cole, said he is on the road.
"Like a lot of people, he got tied up in property that went south," Cole said.
Court records show that Smothers and his ex-wife, a luxury real estate agent with Michael Saunders & Co., borrowed heavily against their two homes during the boom years. But Denby Smothers said there is no reason why her ex-husband should have stopped making interest payments.
"Dick still works and has money to pay his mortgages," she said. "He just chooses not to."
An income statement included in his bankruptcy filing shows that Smothers made $45,300 per month from performances he and his brother have given across the country.
A look at the Smothers Brothers Web site shows that they are booked for 21 concerts this year from Escondido, Calif., to Chatauqua, N.Y., and are to appear in Plant City on March 12.
But a second income statement included in the court filing projects that Smothers will make only about $7,400 per month going forward.

The larger number of $45,300 represents the past and the smaller number represents the future, Cole said.
Denby Smothers, 60, declined to comment further about her husband's financial situation.
The couple got married in Las Vegas in 1997 and filed for divorce in late 2005. That was shortly after Denby Smothers complained in court documents that her husband had pushed her into her car, poked his finger into her chest and told her she had no rights to her house and that their marriage was over.
In their divorce settlement, signed in March 2007, Smothers agreed to provide his ex-wife with $10,000 per month for 36 months to cover mortgage, tax and insurance payments on her 2,000-square-foot, first-floor condo unit with views of Sarasota Bay.
That agreement was set to expire next month.
Both Denby Smothers' condo at 226 Golden Gate Point and Dick Smothers' canal-front house at 460 Meadowlark Drive on Bird Key are listed for sale.
His bankruptcy filing says a short sale contract is pending on the Bird Key house.
Smothers has been coming to Sarasota for more than 20 years and initially stayed at the Colony Beach & Tennis Club.
But in June 2001, he and his ex-wife paid $485,000 for a house in eastern Manatee County.
Two years later, they sold the house for $124,000 more than they paid, and then paid $1.15 million for their Bird Key abode, financing it with $1.2 million in loans from Sarasota Bank.
In 2004 and 2005, they refinanced, increasing their indebtedness on the property to $1.9 million.

A January 2006 article in Herald-Tribune said the property had a low-key beach-house feel with "his" and "hers" kitchens. The article said the couple were trying to sell the house because of their pending divorce.
A few months earlier, they bought the Golden Gate condo unit for $780,000 and eventually borrowed $834,000 against it.
Court records show that Smothers defaulted on his home loan in October 2007, but the loan on the condo unit has remained current.
When called by the Herald-Tribune, Denby Smothers said her ex-husband had not informed her of his intention to file for bankruptcy.

News Research Manager Cindy Allegretto contributed to this report.

Barrett’s esophagus
http://en.wikipedia.org/wiki/Radiofrequency_ablation
Barrett's Esophagus
Radiofrequency ablation has been shown to be a safe and effective treatment for Barrett's esophagus. While the patient is sedated, a catheter is inserted into the esophagus and radiofrequency energy is delivered to the diseased tissue. This outpatient procedure typically lasts from fifteen to thirty minutes. Two months after the procedure, the physician performs an upper endoscopic examination to assess the esophagus for residual Barrett's esophagus. If any Barrett's esophagus is found, the disease can be treated with a focal RFA device. Between 80-90% or greater of patients in numerous clinical trials have shown complete eradication of Barrett's esophagus in approximately two to three treatments with a favorable safety profile. The treatment of Barrett's esophagus by RFA is durable for up to 5 years.[14][15][16][17]

Q. Is this man responsible for the birth of U.S. direct-to-consumer drug/device advertising?

Daniel B. Burke, Leading Media Executive, Dies at 82
Published: October 26, 2011
Daniel B. Burke, who helped engineer the acquisition of the American Broadcasting Company by Capital Cities, one of the boldest corporate takeovers of the 1980s, and went on to become chief executive of the merged company, died on Wednesday at his home in Rye, N.Y. He was 82.
The cause was complications of Type 1 diabetes, according to a statement by the family, which has been powerful in American business and mass communications. His older brother, James, ran Johnson & Johnson, and two of his sons have held top posts at NBC Universal, Disney, TBS, Comcast and the Weather Channel.
Mr. Burke worked for most of his career alongside Thomas S. Murphy, whom he served as a trusted lieutenant and partner. Mr. Murphy had been a Harvard Business School classmate of Mr. Burke’s brother, James.
Daniel Burke and Mr. Murphy were a formidable pair. Together they built Capital Cities through a series of acquisitions and orchestrated the merger with ABC in 1986. While Mr. Murphy was the outside man, happy to be the public face of the company, Mr. Burke thrived as the inside man, the cost-conscious manager much less eager for publicity.
“He was really a partner,” said Mr. Murphy, who described their relationship as a collaboration of equals, even though Mr. Murphy was always a notch higher on the organizational diagram. “It was not a one or a two,” he said of their working relationship.
“As far as running the business and, particularly when we took over ABC, the details of putting that ship in order so we maximized our financial opportunities, a great deal of that was him,” Mr. Murphy said.
Mr. Burke’s son Bill said that Mr. Murphy and Mr. Burke were a “phenomenal team” and became close friends. “They worked together all week,” he said, “and then played golf and tennis all weekend.”
The acquisition of ABC, a much bigger company than Capital Cities, for $3.5 billion stunned the business world. At the time it was the biggest corporate acquisition outside the oil industry.
Despite the surprise, Wall Street reacted positively, not least because Capital Cities brought in Warren E. Buffett to help finance the purchase.
Mr. Burke became president and chief operating officer of the merged company, while Mr. Murphy was chairman and chief executive.
Capital Cities was a highly profitable company that owned television and radio stations, newspapers and trade magazines. ABC was the third-largest network, but still a vast operation that ran television and radio stations and produced programming.
ABC insiders were skeptical about the acquisition at first, but Mr. Murphy and Mr. Burke turned the new company into a well-managed and profitable media conglomerate. Known as cost-cutters, they sought to replace a celebrity-oriented culture at ABC with a less profligate one that emphasized management teamwork.
Mr. Burke could be a tough taskmaster, Mr. Murphy said, but he also had a deft way with people.
Daniel Barnett Burke was born in Albany on Feb. 4, 1929, a son of James and Mary Barnett Burke. His father was an insurance salesman. He grew up in Slingerlands, N.Y., outside Albany, and Dorset, Vt. He graduated from the University of Vermont in 1950, served as an infantry lieutenant in the Korean War in 1951 and 1952, and received an M.B.A. from Harvard in 1955.
After leaving Harvard, he worked for the Jell-O division of General Foods. In 1961, Mr. Murphy hired him to manage an Albany television station owned by Capital Cities. Mr. Burke became chief executive of Capital Cities/ABC in 1990, when Mr. Murphy retired from that position but stayed on as chairman. Mr. Burke retired in 1994.
In 1995 Mr. Murphy pulled off one more mega-deal: negotiating the sale of the company to the Walt Disney Company for $19 billion.
In retirement, Mr. Burke lived in Maine and ran a minor league baseball team, the Portland Sea Dogs.
He was a director of Conrail, the federally operated freight railroad, from 1981 to 1986. He was also a director of the Partnership for a Drug-Free America, and he was a chairman emeritus of New York Presbyterian Hospital in New York City.
Two of his three sons also made careers in media. His oldest son, Stephen, held top posts at Comcast and Disney and in January was named chief executive of NBC Universal. His son Bill was president of TBS and the Weather Channel.
He is also survived by his wife of 54 years, Harriet; another son, Frank; a daughter, Sally McNamara; his brother, James; a sister, Phyllis B. Davis; and 14 grandchildren.
Mr. Burke’s son Bill said he was often asked how the family came to produce so many top corporate executives, across two generations. He said it may have had something to do with Daniel Burke’s parents, a father who was a war hero and a football coach at the University of Vermont and a mother whom he described as highly intelligent and an early feminist. When his father was young, he said, the children were asked to read articles from the newspaper and discuss them at dinner.
But he said it was hard to pinpoint what drove the Burke children to excel in business. “There was something in him and my uncle and my aunts as well,” Bill Burke said. “It was just in their makeup.”