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

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