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Nobel Prize for marketing. “Robotic surgeries are on the rise, fueled by aggressive marketing by doctors, hospitals and Intuitive Surgical Inc. (ISRG), which manufactures the $1.5 million robot.  Advertising on hospital and doctor websites, YouTube videos, billboards, and on radio and television has hyped the advantages of robotic surgeries, often claimed fewer complications without proof, and ignored contradictory studies finding no advantage in some cases.”

“Robot operations haven’t been proven in randomized trials to offer significant health benefits compared to standard, less-invasive surgery and multiple studies show they can cost thousands of dollars more.”

“A 2011 study by doctors at Johns Hopkins School of Medicine also found that 164 hospital robot-surgery websites surveyed “overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer,” according to research in the Journal for Healthcare Quality.”

Excerpted from: Robot Surgery Damaging Patients Rises With Marketing by Robert Langreth, Bloomberg, Oct. 7, 2013

Persistent, important public health problem. “About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows.”

“Acetaminophen has a narrow safety margin: the dose that helps is close to the dose that can cause serious harm, according to the FDA.”

“Over more than 30 years, the FDA has delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen. The agency began a comprehensive review to set safety rules for acetaminophen in the 1970s, but still has not finished.”

Excerpted from: Use Only as Directed by Jeff Gerth and T.Christian Miller, ProPublica, Sept 20, 2013

$hare the pain. “Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.”

“As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.”

“If they succeed, medical device makers… will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates… that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.”

“In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.”

Excerpted: Analysis: When implanted medical devices go wrong, who pays? By Debra Sherman, Reuters Oct 8 2012

The Pinto Legacy: Heinous Calculations. “With all it didn’t have going for it, the Pinto’s greatest legacies arose from its unfortunate propensity to explode its gas tank when hit from behind. Bad press and a general vibe killer, such explosive tendencies…also remind us, frankly, why all the blather we’re treated to every few years about tort reform is so misguided.”

“Consider the matter of Grimshaw v. Ford Motor Company, wherein it emerged that Ford had put its new Pinto on sale with its executives’ full knowledge that a chassis bolt had been placed in a position where it was likely to cause the gas tank to explode in rear impacts.… it was shown that the company openly chose to overlook the gas tank hazard after running an internal analysis which concluded that the $130 million cost of making a design change would outstrip that of settling an anticipated 180 wrongful death and 180 additional burn injury cases each year. Ford’s heinous math turned out all wrong.”
Excerpted from: Don’t Like Government Regulation? How’d You Like Another Pinto? by Jamie Lincoln Kitman (New York Bureau Chief for Automobile Magazine), Car Talk Blog March 24, 2011

I, Jack, accept full liability for the genetically modified beanstalk.  “Monsanto has an interesting clause in its seed [GMO] contract. The Monsanto Technology Stewardship Agreement has a waiver that shifts all liability from any incidental, direct, indirect consequences from its seeds from the company to the farmer.”

“Apparently, Monsanto is so sure that their seeds are problem-free that they refuse to take responsibility for them...”  Excerpted from: Not Monsanto's Fault! Ever. By Eric Holt Gimenez of Food First/Institute for Food & Development Policy, Huffington Post 3-2-11

What’s that smell?  After years of so-so success, lawsuits against factory farms, also known as concentrated animal feeding operations (CAFOs), are gaining traction …

Individuals, families and small farmers living next to factory farms have been suing in droves over noxious odors wafting through their neighborhoods that they claim interfere with the use and enjoyment of their property.

The concentrated aspect of CAFOs means that thousands of animals are housed in the same operation. Their waste is shoveled into lagoons and later spread onto fields as fertilizer.
Excerpted from: Litigation against factory farms finds new momentum by Sylvia Hsieh, Lawyers Weekly USA 9-13-10

YUCK!  Federal officials investigating conditions at the two Iowa mega-farms whose products have been at the center of the biggest egg recall in U.S. history found filthy conditions, including chickens and rodents crawling up massive manure piles and flies and maggots "too numerous to count."

Food safety experts said conditions described in the reports are some of the worst they've seen in decades. They found:

•Barns with dozens of holes chewed by rodents that mice, insects and wild birds used to enter and live inside the barns;

•Flies on and around the egg belts and hen feeders;

•Manure built up in 4- to 8-foot-tall piles in pits below the hen houses, in such quantities that it pushed pit doors open, allowing rodents and other wild animals access to hen houses;

•Dozens of hens, which had escaped their cages, roaming freely, tracking manure from the pit to other caged parts of the barns;

•Hen houses with significant structural damage and improper air ventilation systems.
Excerpted from: Filthy conditions found at egg producers By Andrew Zajac and P.J. Huffstutter, Los Angeles Times 8-31-10

Voluntary Product Safety. “…when Kellogg recalled 28 million boxes of [cereal], the company blamed elevated levels of a chemical [2-methylnaphthalene] in the packaging.”
“Dozens of consumers reported a strange taste and odor, and some complained of nausea and diarrhea. But Kellogg said a team of experts it hired determined that there was "no harmful material" in the products.”

“Federal regulators...are in the dark about the suspected chemical, 2-methylnaphthalene.”

“The information gap is hardly new. When the Toxic Substances Control Act was passed in 1976, it exempted from regulation about 62,000 chemicals that were in commercial use -- including 2-methylnaphthalene. In addition, chemicals developed since the law's passage do not have to be tested for safety. Instead, companies are asked to volunteer information on the health effects of their compounds…”
Excerpted from: U.S. regulators lack data on health risks of most chemicals By Lyndsey Layton, Washington Post, 8-2-2010

Watch what you eat… "In Texas, Peanut Corp. of America operated a processing plant in Plainview that was not registered with — and therefore never inspected by — state health officials. Health officials eventually shut the plant because of unsanitary conditions." "So far, the agency [Texas Department of State Health Services] has found about 350 companies that were not properly registered with the health department. But there's still a lot of looking to do to check whether some of the more than 55,000 businesses registered with the state comptroller manufacture or process food…."

Annual effects of food-borne pathogens in Texas:
•    6 million people get sick.
•    26,000 are hospitalized.
•    400 people die.
Sources: U.S. Centers for Disease Control and Prevention, Texas Department of State Health Services

Salmonella cases in Texas
•    Before 2008: Texas had a yearly average of 3,000 to 3,500 salmonella cases.
•    In 2008, there were 4,500 cases.
Source: Texas Department of State Health Services
Excerpted from: Two years after peanut scare, little regulatory change By Tim Eaton, Austin American Statesman 7-26-10

May I have some regulation with my salad?  “Food-borne illnesses cost the United States $152 billion a year…an average cost of $1,850 each time someone gets sick from food, a report by a former Food and Drug Administration economist says.” [Robert Scharff, a former FDA regulatory economist and now a professor of consumer science at Ohio State University.]

“The costs include medical services, deaths, lost work and disability. They are based on data from the U.S. Department of Agriculture, the Centers for Disease Control and Prevention and the FDA.”

“Scharff hopes policymakers can use his methodology to determine which regulations would give the biggest bang for the buck…," he says.”

“…consumers are spending $85 billion on the consequences of unsafe food for every $1 billion the government is spending to prevent it," says Caroline Smith DeWaal, food safety coordinator for the Center for Science in the Public Interest.”
Excerpted from: USA pays price for food-borne illness: $152B a year by Elizabeth Weise, USA Today, March 4, 2010

Baiting-and-switching. “The Toyota situation should be a wake-up call for Texas policymakers: The decades-long campaign by insurance companies and multinational corporations to shift responsibility for consumer protection away from independent judges and common-sense juries…has put families at risk in their workplaces, on the highways and in our healthcare system”.

“…when patients' legal rights were severely restricted…by the [Texas]Legislature in 2003, an office of patient protection was created. It was a bait-and-switch. The agency's funding never materialized, and two years later the office was shut down entirely before it ever had a chance to help a single patient”.
Excerpted from: Op-ed - Texas must stop protecting public safety on the cheap by N. Alex Winslow (Texas Watch), Fort Worth Star Telegram 3-11-10

Technology + Radiation - Regulation = Failure to Protect Patients. "At a 2007 conference on radiation safety, medical physicists...warn[ed] that radiation oncology "does indeed face a crisis." The gap between advancing technology and outdated safety protocols leaves "physicists and radiation oncologists without a clear strategy for maintaining the quality and safety of treatment..."

"Government regulators have been slow to respond. Radiation accidents are chronically underreported, and a patchwork of laws to protect patients...are weak or unevenly applied, creating an environment where the new technology has outpaced its oversight..."

"In this largely unregulated marketplace, manufacturers compete by offering the latest in technology, with only a cursory review by the government...Radiation-generating machines are so ubiquitous that used ones are even sold on eBay."
Excerpted from: As Technology Surges, Radiation Safeguards Lag by Walt Bogdanich New York Times 1-27-10

You Are What You Eat? Ewwwww. "After decades of steady progress, the safety of the nation's food supply has not improved over the past three years... The report, from the Centers for Disease Control and Prevention, demonstrates that the nation's food safety system, created when most foods were grown, prepared and consumed locally, needs a thorough overhaul to regulate an increasingly global food industry, top government health officials said Thursday."

"Roughly 76 million people in the United States suffer foodborne illnesses each year, 300,000 are hospitalized, and 5,000 die, according to C.D.C. estimates. Children younger than 4 are sickened by food more than those in any other age group...."
Excerpted from: U.S. Food Safety No Longer Improving By GARDINER HARRIS, NY Times 4-9-09

Directions: Apply Pressure and Wait. "Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints."

"It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!" states the letter..."

"The letter is the latest escalation in a highly unusual internal battle... The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective."
Excerpted from: Dissidents at F.D.A. Complain of Inquiry, By Gardiner Harris New York Times 1-28-09

Is this intended to be reassuring? "Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula, but federal regulators insist the products are safe."

"The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it."
Excerpted from: FDA finds traces of melamine in US infant formula By MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press 11-26-08