FDA Relying on Medical Fraud to Promote Devices
March 2, 2010
Natural News
By Ethan A. Huff
The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.
Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA’s safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.
When drugs are approved, they typically go through a series of studies prior to even being evaluated by the FDA. A medical device, however, can be approved based on the results of a single study which may or may not contain important specifics such as who participated in the study. Critics note that, since a medical device is usually a permanent addition to someone’s body, it deserves even more intense scrutiny than prescription drugs which can be discontinued if found to be harmful. This is especially true with heart devices that are necessary in order to keep a person alive.
Dr. Jeffrey Shuren, acting director of the FDA’s device division and co-author of one of the studies, conceded that the FDA’s process for evaluating medical devices is inadequate. He explained that the FDA is working on creating stronger standards for evaluation and approval but that device manufacturers need to work more closely with them to establish study goals.
Janet Trunzo, an executive vice president of AdvaMed, an advocacy group for the medical device industry, defended the FDA’s current approach to approving medical devices. She expressed that device manufacturers submit extensive data to the FDA who spends 1,200 hours reviewing it all prior to approving a device.
Many approved medical devices have been recalled over the years for safety reasons. The FDA maintains a list of the most serious medical device recalls for which the products in question may cause “serious health problems or death.” There are over 30 devices on the list from 2009 alone. Since 2004, there have been 137 medical devices recalled by the FDA.
Click here for the full report.
Two Seats for Obese: Air France to Charge Large Passengers.
January 22, 2010
Telegraph
From next month seriously overweight flyers will be asked to pay for two seats, or not be allowed on board for “safety reasons”, the airline announced yesterday.
“People who arrive at the check-in desk and are deemed too large to fit into a single seat will be asked to pay for and use a second seat,” said Monique Matze, an Air France spokesman.
“They will be charged 75 per cent of the cost of the second seat, which is the full price excluding tax and surcharges, on top of the full price for the first.
“The decision has been made for safety reasons. We have to make sure that the backrest can move freely up and down and that all passengers are securely fastened with a seatbelt.”
She added: “People who cannot fit into a single seat will then be fastened by slotting the belt tip of one seat into the plug of the next, stretching over both seats.
“However the charge will only apply on flights that are full booked. They will get their money back on flights where spaces are available.”
Two years ago Air France was ordered to pay £5,000 in damages to a 27-stone passenger who had his stomach measured at an airport check-in desk before being told to buy two seats.
British Airways has no weight limits for passengers, but advises overweight people to buy a second seat for their own comfort and safety if necessary.
Last year a picture, posted the aviation news website, Flightglobal, reignited the debate about obese passengers on aeroplanes.
Click here for the full report
U.S. to Raise Airline Security Even more
January 19, 2010 by joel
Filed under Government
January 19, 2010
MSNBC
The Department of Homeland Security is further increasing aviation security in response to intelligence indicating Islamist terrorists were planning another attack on the United States.
The new regulations — which are to be announced later Thursday — were not described in detail, but a senior U.S. official told NBC News on condition of anonymity that they would include further in-flight restrictions in passengers’ movement, more random pre-flight screening of passengers and an increase in the number of federal air marshals on flights.
“In view of the event of Christmas Day we must remain vigilant about the continued threat we face from al-Qaida,” Homeland Security Secretary Janet Napolitano said in a statement after NBC News disclosed the new measures. “We are taking an additional set of aviation security precautions to protect the American people.”
The tightened security comes after U.S. officials said new intelligence data suggested that the al-Qaida offshoot in the Arabian country of Yemen was planning another attack on the United States. A British-based Nigerian man affiliated with the group is believed to have been responsible for the aborted attempt to bomb a jetliner over Detroit on Christmas Day.
The new intelligence was first reported Wednesday by NBC News, which quoted three U.S. officials as saying the intelligence was considered credible. The officials would not describe the information or say whether it indicated a specific target or date.
“No one believes al-Qaida in the Arabian Peninsula has stopped planning for attacks on the United States,” one of the officials said. “No one believes that the events of December 25 are the last we will see of these guys.”
A second official said the information did not come from interrogation of Umar Farouk Abdulmutallab, 23, who pleaded not guilty this week to trying to ignite an explosive in his underpants on Northwest Airlines Flight 253.
Click here for the full report
The Real Purpose of Body Scanners
January 7, 2010 by JP
Filed under Government
January 7,2009
Prison Planet
By Steve Watson
The clamor to ramp up airport security with invasive naked body imaging scanners has nothing to do with ensuring the safety of travelers. Rather it is part of an ongoing incremental push to break the will of the people and encourage mass subservience and meek obedience.
Perhaps the most alarming aspect of the body scanner push is that people are willingly accepting it. As Bloomberg news reports today, “Passenger acceptance of airport body scanners has increased following the failed terrorist attack,” with 92% of passengers at Manchester airport in northern England now agreeing to pass through the machines in a voluntary trial, compared with 75 percent before the incident.
The same report indicates that Around 90% of Muslims and Orthodox Jews were opting to use the scanners even prior to the Detroit incident rather than risking physical contact via pat downs and strip searches.
Travelers in Canada have indicated acceptance of the scanners, saying that they would “do anything for safety” and describing them as “a necessary evil”.
Meanwhile, nearly two-thirds of Germans favour airports using full-body scanners, despite claims that they are an invasion of personal privacy, a new poll has shown.
The will of the people is being systematically eroded and incrementally broken down. Airports are serving as reservations where the fundamental right to privacy must be left at the door.
Travelers have been acclimatized over time to know they must remove their shoes, take off their belts, untuck shirts, discard water, baby milk, shampoo and toothpaste. During the flight hands must be visible on laps, and even bathroom visits can now become national incidents as we have recently seen.
A culture of extreme fear has been engendered where the only way to stay safe is to cozy up to big brother, a psychological response akin to that of Stockholm syndrome.
This is where the technological control grid plays such a key role. Imagine if TSA agents were made to take women and children and physically strip search them while they held their hands aloft, the public would balk at such an abuse. However, with the body scanning machines there is a divide that clouds the process in futuristic technology.
Click here to read the full report
E-Coli Infected Beef Infects 21 People
December 30, 2009
The Washington Post
By Lyndsey Layton
Twenty-one people in 16 states have been infected in recent days with a potentially lethal strain of E. coli bacteria, after consuming beef in restaurants supplied by the same Oklahoma meat company, federal officials said.
The outbreak spurred the company, National Steak and Poultry, to voluntarily recall 248,000 pounds of beef Dec. 24. The products, which range from steaks to sirloin tips, were packaged in October and shipped to restaurants, hotels and institutions nationwide, according to the company.
The U.S. Department of Agriculture’s Food Safety and Inspection Service has only a partial list of restaurants that received the potentially tainted beef, including two chains, Moe’s and Carino’s Italian Grill, primarily in the West and Midwest.
The recall is considered a “class 1″ or a “high health risk” by the USDA, which regulates the meat industry, because among the pathogens that can harm human health, E. coli O157:H7 is one of the most lethal. Even for those who survive, there can be long-term health effects.
Nine of the 21 sickened have been hospitalized, the USDA reported. The department has identified cases in six states — Colorado, Iowa, Kansas, Michigan, South Dakota and Washington
The agency said the contamination appears to have begun with tainted beef used for chopped steak that was “co-mingled” with other products in the plant. Jerry Mande, the USDA’s deputy undersecretary for food safety, said the investigation is continuing. A telephone message left for the company was not returned.
FDA Branching out to Other Countries
December 30, 2009
Natural News
By Mike Adams
In its supposed efforts to improve food safety, the U.S. Food and Drug Administration (FDA) recently announced the opening of its third Latin American facility located in Mexico City. Since an increasing quantity of fruits, vegetables, and medical devices are being imported into the U.S. from Mexico, FDA officials believe setting up outposts there will improve the food safety process.
Throughout the past year, FDA has opened ten facilities around the globe. Because of numerous recent contamination outbreaks, regulators claim that establishing permanent international offices will improve their ability to operate effectively.
The agency plans to work collaboratively with international governments and food regulators to harmonize regulatory standards, establish new food safety guidelines, and improve product handling safety protocols.
U.S.-based staff is now working in FDA facilities in China, India, Chile, Costa Rica, Mexico, and several European countries. Native regulatory agencies in these countries are still said to be in charge of monitoring food safety, but FDA is there to provide an additional point of control for helping these agencies meet U.S. safety standards and avoid food contamination and other problems.
Dr. Murray Lumpkin, FDA Deputy Commissioner for International Programs, says that at the new Mexican facility, FDA staff will work with the Mexican government and its regulatory bodies to establish certification programs that will help them to conform to U.S safety expectations. He believes the relationship will help foster openness and allow for better oversight of the import and export process between the two nations.
WHO: H1N1 Might Take a Year to Conquer
December 29, 2009
Reuters
By Stephanie Nebehay
WHO Director-General Margaret Chan also warned that although countries have shored up their defenses against the first influenza pandemic in more than 40 years, they remain ill-prepared for mass outbreaks of the deadlier bird flu virus.
“It is still premature and too early for us to say we have come to an end of the pandemic influenza worldwide. It would be prudent and appropriate … to continue to monitor the evolution of this pandemic for the next six to 12 months,” Chan told a year-end news conference.
“The one thing we need to guard against is a sense of complacency,” she added.
Countries including Britain, Canada and the United States have passed peaks of a second wave of H1N1, but outbreaks are intensifying in India, Egypt and elsewhere, according to Chan.
H1N1 has now spread to more than 200 countries, with nearly 12,000 deaths confirmed in laboratory, but it will probably take two years to establish the true death toll, she said.
Millions of people have been infected with the virus which emerged in April, most recovering without special treatment.
But young people, pregnant women and people with underlying health conditions such as heart or lung disease are more vulnerable and often require intensive care in hospital.
Influenza viruses are notoriously unpredictable and can mutate into more severe forms, according to the WHO chief.
Chan, who admitted she had not received her own H1N1 flu shot yet but would have it soon, said: “I am a bit more relaxed, but I will never let down my guard.”
VACCINES FOR POOR COUNTRIES
Rich countries and drug companies have pledged to donate 190 million doses of H1N1 vaccine for use in some 90 developing countries, she said.
Her United Nations agency plans to start distributing the first doses in Azerbaijan and Mongolia in early January, to be followed by Afghanistan, she added.
On recalls of some H1N1 vaccine — by AstraZeneca’s MedImmune unit and Sanofi-Aventis SA — she said they were because they were not as potent as they should be but posed no risk.
“The recalls are not related to safety of vaccines,” she said, saying the issue had been dealt with in an “ethical way.”
Chan, noting the world’s financial crisis and weak health systems in some countries, said: “The fact that the long overdue influenza pandemic is so moderate in its impact is probably the best health news of the decade.”
But Chan, who fought avian flu and SARS while serving as health director in her native Hong Kong, said the world was still not ready to combat a pandemic of the H5N1 bird flu virus, noting it was “more toxic and deadly.”
“No, the world is not ready for a pandemic to be caused by H5N1,” she said.
Click here for the full report.
Tyson Foods Under FDA Watch for Serious Violations
December 2, 2009
Reuters
By Tim Dobbyn
U.S. regulators have warned Tyson Foods Inc about “serious violations” of food safety regulations at a Texas plant where the company makes seafood soup, a letter released on Tuesday said.
Seafood soups and sauces made at a Fort Worth, Texas, plant were “prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health,” the Food and Drug Administration said in a Nov. 13 letter to the company.
Tyson Foods spokesman Gary Mickelson said the company believed “this is really a documentation issue involving the plant’s written food safety plan.” He said the FDA wanted Tyson to document a temperature control procedure for thawing some seafood, and the company had made that change.
“Contrary to the impression left by the FDA letter, our Fort Worth plant is clean and sanitary and the products produced there are safe to eat,” Mickelson said via email.
The shrimp and crabmeat that FDA inspectors observed being thawed at the plant was discarded, he added.
The FDA sends dozens of warning letters each year. Most issue raised are resolved without further action, although the letters can lead to product seizures or other actions.
Shares of Tyson Foods were up 1.3 percent to $12.17 in afternoon trading on the New York Stock Exchange, matching a broad-based gain for stocks.
Corporations Looking to Reduce Toxic Footprint
December 2, 2009
ENN
By Richard Liroff
Companies need to move towards using greener chemicals because the principal drivers demanding such change — science, regulation, and business-to-business environmentally preferable purchasing programs — are surging and will intensify.
Product toxicity reduction should be a core element of business strategy because it can reduce reputational and litigation liabilities, help companies avoid “toxic lockout” of their products from the marketplace, and drive innovation.
It can drive sales in the marketplace for environmentally preferable products, lower overhead costs when products subject to government hazardous waste laws are eliminated, and contribute to enhanced employee safety and productivity. Toxicity reduction and elimination can also yield other forms of cost savings, generally determined on a case by case basis.
In the course of this three-part series, we aim to help you figure out how to reduce your company’s toxic footprint by reducing and eliminating the “worst of the worst” toxic chemicals and promoting use of “best of the best” green ones.
Health and Safety Snoops to Enter Family Homes
November 20, 2009
The Sunday Times
By Robert Watts
Health and safety inspectors are to be given unprecedented access to family homes to ensure that parents are protecting their children from household accidents.
New guidance drawn up at the request of the Department of Health urges councils and other public sector bodies to “collect data” on properties where children are thought to be at “greatest risk of unintentional injury”.
Council staff will then be tasked with overseeing the installation of safety devices in homes, including smoke alarms, stair gates, hot water temperature restrictors, oven guards and window and door locks.
The draft guidance by a committee at the National Institute for Health and Clinical Excellence (Nice) has been criticised as intrusive and further evidence of the “creeping nanny state”.
Until now, councils have made only a limited number of home inspections to check on building work and in extreme cases where the state of a house is thought to pose a serious risk to public health.
Nice also recommends the creation of a new government database to allow GPs, midwives and other officials who visit homes to log health and safety concerns they spot.
The guidance aims to “encourage all practitioners who visit families and carers with children and young people aged under 15 to provide home safety advice and, where necessary, conduct a home risk assessment”. It continues: “If possible, they should supply and install home safety equipment.”
The proposals have been put out to consultation and, if approved, will be implemented next year.
Matthew Elliott, of the TaxPayers’ Alliance, said: “It is a huge intervention into family life which will be counter-productive.
“Good parents will feel the intrusion of the state in their homes and bad parents will now have someone else to blame if they don’t bring up their children in a sensible, safe environment.”
About 100,000 children are admitted to hospital each year for home injuries at a cost of £146m.
