Sunday, June 14, 2009
Department of Health and Human Services Approves Fictitious Medical Device Review Board Led by a Dead Dog
(NaturalNews) Just how trustworthy are medical review boards that review and approve medical devices? In a Government Accountability Office (GAO) sting, investigators were able to invent and register a fictitious review board with the Department of Health and Human Services (HHS), complete with a fictitious panel of doctors and a canine president named "Truper Dawg" (named after a real pet dog that had long since passed away).
Names of other board members on the fictitious organization approved by the Department of Health and Human Services included "April Phuls" and "Timothy Wittless." These names apparently did not raise any suspicions at the HHS. (Perhaps the U.S. government thought the review board was being run by a group of badly-named rappers?)
But that's not all: To check out the credibility of existing Independent Review Boards (IRBs), the GAO invented a fictitious medical product called Adhesiabloc -- an adhesive gel used as a kind of "stomach superglue" following surgery. A proposal to begin a clinical trial of this adhesive gel on humans was submitted to an FDA-recognized IRB company, and the company approved it! This, despite the fact that the clinical trial called for pouring one liter of this adhesive gel into the stomach of patients.
Misleading the misleaders
The IRB that fell for the ruse was Coast IRB, LLC of Colorado Springs, which after being caught, charged that the GAO investigators violated federal law by misrepresenting themselves when they submitted false credentials to the review company.
But isn't this exactly what a medical review company is supposed to notice and prevent in the first place? This company seems to think they can trust everything they're told by any person or company applying for review, regardless of whether the medical products in question make any sense at all.
Coast IRB is one of 6,300 IRBs (Independent Review Boards) that certify pharmaceutical trials and medical device trials for consideration by the FDA.
The next time you considering using an "FDA-approved" medical device or pharmaceutical, remember this simple truth: In America, the Department of Health and Human Services will certify a fictitious review company headed by a dog!
If the GAO can pull this off after running the sting on just 3 companies, imagine how many of the 6,300 IRBs are certifying fraudulent, dangerous or outright deadly medical devices and pharmaceuticals right now!
What this fiasco really shows is that the medical device oversight system in America today is a complete joke. With the right paperwork, a medical device company could get review board approval for practically anything. And with the HHS accepting the credentials of fictitious review boards, the overseers of the review boards are so incompetent in their own jobs that the credibility of the whole system must be called into question.
Combine this with the corruption at the FDA, and you have to really wonder: Just how safe are the medical devices and pharmaceuticals being used by over a hundred million Americans right now? The answer, of course, is that many of them may have simply been rubber-stamped by dishonest or incompetent review board companies and HHS bureaucrats who have now been utterly exposed as either criminally dishonest or shockingly incompetent.
Sources for this story include:
Wall Street Journal: http://online.wsj.com/article/SB123...
Associated Press: http://www.google.com/hostednews/ap...
Names of other board members on the fictitious organization approved by the Department of Health and Human Services included "April Phuls" and "Timothy Wittless." These names apparently did not raise any suspicions at the HHS. (Perhaps the U.S. government thought the review board was being run by a group of badly-named rappers?)
But that's not all: To check out the credibility of existing Independent Review Boards (IRBs), the GAO invented a fictitious medical product called Adhesiabloc -- an adhesive gel used as a kind of "stomach superglue" following surgery. A proposal to begin a clinical trial of this adhesive gel on humans was submitted to an FDA-recognized IRB company, and the company approved it! This, despite the fact that the clinical trial called for pouring one liter of this adhesive gel into the stomach of patients.
Misleading the misleaders
The IRB that fell for the ruse was Coast IRB, LLC of Colorado Springs, which after being caught, charged that the GAO investigators violated federal law by misrepresenting themselves when they submitted false credentials to the review company.
But isn't this exactly what a medical review company is supposed to notice and prevent in the first place? This company seems to think they can trust everything they're told by any person or company applying for review, regardless of whether the medical products in question make any sense at all.
Coast IRB is one of 6,300 IRBs (Independent Review Boards) that certify pharmaceutical trials and medical device trials for consideration by the FDA.
The next time you considering using an "FDA-approved" medical device or pharmaceutical, remember this simple truth: In America, the Department of Health and Human Services will certify a fictitious review company headed by a dog!
If the GAO can pull this off after running the sting on just 3 companies, imagine how many of the 6,300 IRBs are certifying fraudulent, dangerous or outright deadly medical devices and pharmaceuticals right now!
What this fiasco really shows is that the medical device oversight system in America today is a complete joke. With the right paperwork, a medical device company could get review board approval for practically anything. And with the HHS accepting the credentials of fictitious review boards, the overseers of the review boards are so incompetent in their own jobs that the credibility of the whole system must be called into question.
Combine this with the corruption at the FDA, and you have to really wonder: Just how safe are the medical devices and pharmaceuticals being used by over a hundred million Americans right now? The answer, of course, is that many of them may have simply been rubber-stamped by dishonest or incompetent review board companies and HHS bureaucrats who have now been utterly exposed as either criminally dishonest or shockingly incompetent.
Sources for this story include:
Wall Street Journal: http://online.wsj.com/article/SB123...
Associated Press: http://www.google.com/hostednews/ap...
Monday, June 8, 2009
Lobbyists unlimited in honoring lawmakers (Ed. note: corruption?)
WASHINGTON — On a mild evening last September, Citigroup lobbyists mingled with South Carolina Rep. James Clyburn at a rooftop reception — complete with miniature putting greens — as the company hosted a party to honor the third most powerful Democrat in the House and raise money for one of his favorite golf charities.
Health insurers and hospitals, meanwhile, are donating millions to help build an institute in Boston to celebrate the career of Sen. Edward Kennedy, D-Mass., who is attempting to overhaul the nation's health care system. (Ed. note: influencing the lawmakers?)
Despite a ban on gifts to lawmakers and limits on campaign contributions, lobbyists and groups that employ them can spend unlimited money to honor members of Congress or donate to non-profits connected to them or their relatives. The public — until now — had little insight into the scope of this largely hidden world of special-interest influence.
Under ethics rules passed in 2007, lobbyists for the first time last year had to report any payment made for an event or to a group connected to a lawmaker and other top federal officials.
USA TODAY undertook the first comprehensive analysis of the lobbying reports and found 2,759 payments, totaling $35.8 million, were made in 2008. The money went to honor 534 current and former lawmakers, almost 250 other federal officials and more than 100 groups, many of which count lawmakers among their members.
The total cost is roughly equivalent to what the U.S. government spends to operate Yellowstone National Park each year.
Most of the money — about $28 million — went to non-profit groups, some with direct ties to members of Congress. In two cases, USA TODAY found, the donations to non-profits associated with a member of Congress came in response to a personal appeal for funds from the lawmaker.
"It's another example of the many pockets of a politician's coat," says Ellen Miller of the Sunlight Foundation, a watchdog group. The spending amounts to an "end-run" around campaign-finance laws "that are designed to limit the appearance of undue influence," she says.
The money came from companies, trade associations and labor groups that lobby Congress and the government on a range of issues, from seeking a share of last year's $700 billion financial bailout package to trying to shape the debate on climate change.
The donations cover various activities — from a golf tournament that raises money for a lawmaker's non-profit to gifts to the alma mater of a powerful House committee chairman.
"You can still have a gala or something or the other for a charity and earn some favor with members of Congress, which is what the gift ban was put in place to avoid," says Dan Danner, CEO of the National Federation of
The spending demonstrates the subtle ways that special-interest groups try to sway lawmakers, without making "something as crass as a payoff," says Kenneth Gross, a former Federal Election Commission official.
He credits Congress for mandating the disclosure of the gifts and giving the public another view of the relationships between lobbyists and lawmakers.
Invitation to access
The lobbying reports were required by Congress after former lobbyist
What is more common — and legal — are donations such as the $40,000 AT&T gave in December to the Blanchette Rockefeller Neurosciences Institute, which researches Alzheimer's. Sen.
These are "not run-of-the-mill charities," says Steve Ellis, vice president of
Last year, the telecommunication industry gave more than $72,000 to non-profits and charities in honor of Rockefeller, who advocated legislation to provide legal immunity to phone companies that participated in the government's anti-terrorism eavesdropping program. The largest donation came from AT&T. At the time, Rockefeller chaired the Senate Intelligence Committee and helped broker a deal on the bill, which passed last year.
Rockefeller oversees the telecom industry as chairman of the Commerce, Science and Transportation Committee.
Claudia Jones, an AT&T spokeswoman, declined comment.
Interviews show the West Virginia Democrat made a direct appeal to another company for a donation to the institute.
"It would be foolish to think we don't take note of the fact when a member of Congress says, 'Hey, I think this is something you ought to support,' " Hoffman says.
Rockefeller spokeswoman Jamie Smith declines to discuss the solicitation but says there is no connection between the gifts and the senator's official actions.
"If some in Washington think giving to a cause Jay Rockefeller cares about will affect his policy views, they surely don't know him," she said in an e-mail. "His policies are based on the merits of an issue and on what's good for West Virginia and the country — period."
Rep.
Lobbyist ties remain
Despite a pledge by congressional leaders to sever ties between lawmakers and special interests, the reports show lobbyists often give to non-profits associated with the lawmakers who regulate their industries.
Health care groups, for instance, give millions to the planned
Kennedy, who is battling brain cancer, chairs the Senate's health and education committee and is at work on comprehensive health care legislation. Aetna has engaged in private talks with Kennedy aides on the bill, Aetna spokesman Mohit Ghose says.
Ghose says the donation was unrelated to those negotiations and instead "advances our goal of continuing to take a leadership role in public policy."
Kelley Davenport, a spokeswoman for Amgen, says the donation reflected the company's interest in lauding Kennedy's long career and in helping "young people to become engaged in public service and public policy."
Kennedy, the records show, was the most honored member of Congress, with a total of nearly $6 million. Most of the money went to the Kennedy institute.
Kennedy spokeswoman Melissa Wagoner and institute trustee Paul Kirk say the Democratic senator has steered clear of potential conflicts of interest with his official duties by not soliciting donations. In total, the organization has collected more than $20 million, according to a January institute news release.
"The principal reason fundraising is going so well is that there is an enormous outpouring of appreciation for Sen. Kennedy's public service," Kirk says.
Amgen spent the most in honor of members of Congress last year, the analysis found. It was among 20 corporations and unions responsible for $17.6 million — or nearly half — of the spending in honor of lawmakers and federal officials last year, the USA TODAY analysis shows. Those groups spent a total of $137.5 million to lobby Congress and federal agencies last year.
Amgen also donated to the Frontier Foundation in honor of Rep. Steve Buyer, R-Ind., who is on the House panel that regulates the drug industry.
The foundation, which provides college scholarships and once was headed by Buyer's daughter, received $385,000 in donations from pharmaceutical companies from 2005 through 2007, according to its
Buyer, who has worked on health policy in Congress for years, helped kill a provision in 2007 opposed by drug companies and broadcasters that would have imposed a three-year ban on advertising new drugs, congressional records show. Consumer advocates, including the Consumers Union, pushed the measure, arguing that aggressive drug pitches unduly sway patients to seek treatment from drugs before their safety records have been established.
During debate by a Commerce subcommittee, Buyer co-sponsored an amendment that stripped the advertising ban from a larger bill overhauling the Food and Drug Administration.
In an interview, Buyer said "there is no connection" between his legislative actions and donations to the foundation. "I'm not an officer. I'm not a board director," he said of his role in the non-profit. "Do I help the foundation? Yes, I do. Do I help other charity groups? Yes, I do."
He referred other questions to foundation officials.
The charity's IRS filing covering the year 2007, the most recent available, listed Buyer's daughter, Colleen, as its unpaid president. Stephanie Mattix, listed as the group's paid secretary/treasurer, is executive director of Buyer's political action committee, Storm Chasers, according to Federal Election Commission filings.
Mattix and Buyer told USA TODAY that Colleen Buyer had left the group and referred questions to its president, Brenda Olthoff. Olthoff did not respond to e-mails and calls. Colleen Buyer did not return telephone calls.
The
"I don't think there is a link between a specific vote on drug legislation and contributing to kids going to college in Indiana," says Dennis Wharton, the broadcasters' executive vice president. "We look at where we think it's a worthy cause."
Davenport, Amgen's spokeswoman, says the gift matched the company's "philanthropic mission to improve education."
Contributing: Jack Gillum, Seung Min Kim
Monday, June 1, 2009
Top 10 Ways the Restaurant Industry is Hijacking Your Brain
Is the food industry taking its cues from the tobacco industry?
From the book The End of Overeating by David A. Kessler, a Rodale Inc. publication
Overeating doesn’t only affect people who are overweight. In fact, more than 70 million Americans have become conditioned to overeat, and it affects people of all different weights. Dr. Kessler pulls back the curtain to reveal how the food industry and its scientists really operate.
1. Most of the foods served at restaurants combine tempting amounts of sugar, fat, and salt. They are either loaded onto a core ingredient (such as meat, vegetable, potato, or bread), layered on top of it, or both. For instance:
- Potato skins: The potato is hollowed out and the skin is fried, which provides a substantial surface area for “fat pickup.” Then some combination of bacon bits, sour cream, and cheese is added. The result: fat on fat on fat on fat, loaded with salt.
- Buffalo wings: The fatty parts of a chicken get deep-fried. Then they are served with creamy or sweet dipping sauce that’s heavily salted. Usually they’re par-fried at a production plant, then fried again at the restaurant, which doubles the fat. The result: sugar on salt on fat on fat on fat.
- Spinach dip: The spinach provides little more than color—a high-fat, high-salt dairy product is the main ingredient. The result: a tasty dish of salt on fat.
3. The food industry develops “fun foods.” By creating hyperpalatable foods that are entertaining, widely available and socially acceptable, the food industry contributes to this vicious cycle. Millions of Americans report loss of control in the face of food, lack of feeling satisfied, and a preoccupation with these foods.
4. The food industry creates “adult baby food.” Fun food literally melts in your mouth: by eliminating the need to chew, modern food processing techniques allow us to eat faster and consume more calories. Processing meat and produce—a techniques employed by many restaurant chains and food manufacturers—creates a kind of “adult baby food.” The harder-to-chew-elements—such as fiber and gristle—are removed. The result is food that can be eaten quickly, and without much effort.
5. Faster consumption and cost-saving steps. Consider Chili’s boneless Shanghai chicken wings: A food designer says that about them, “taking it off the bone is like taking the husk off the nut.” That processing step reduces the need for chewing, making the food faster to consume. The wings contain a solution of up to 25 percent water, hydrolyzed soy protein, salt, and sodium phosphate. The water is there to bulk up the chicken—the industry calls this “reducing shrinkage.” Water is also cheaper than chicken breast, so it’s less costly to produce. And finally, water makes the food softer and chewing easier.
6. "When in doubt, throw cheese and bacon on it” is a standard joke in the world of chain restaurants. But it works. Along with enhancing melt and making food easy to eat, these layers are cheaper to produce than the central ingredient (such as meat or fish) they flavor. They’re also visually appealing, straightforward, and familiar. Example: T.G.I. Friday’s Parmesan-Crusted Sicilian Quesadilla, is described on the menu as follows: “Packed with sautéed chicken, sausage, bruschettta marinara, [and] bacon and oozing with Monterey Jack cheese. We coat it with Parmesan and pan-fry it to a crispy, golden brown, then drizzle it with balsamic glaze.”
7. Food is assembled, not actually cooked, in chain restaurant kitchens. These restaurants make use of “individually quick frozen” foods. Shrimp, potatoes, and chicken nuggets are blasted with cold air, cold nitrogen, or cold carbon dioxide as they travel along a conveyor belt so they freeze in discrete pieces. They are often partially fried before they are quick-frozen. Then they are plunged, straight from the package and still frozen, back into fat for a second frying.
8. Think you’re eating healthy when you order grilled, marinated chicken? Think again. A common way to get marinade into meat is through needle injection. Hundreds of needles are used to pierce the meat, tearing up the connective tissue, to add solutions of salt, sugar, and fat. These injections not only increase flavor, but they also make the meat fall apart in our mouths.
9. Sugar by another name. If a food containes more sugar than any other ingredient, federal regulations dictate that sugar be listed first on the label. So, to trick health-conscious mothers who scan food labels for the word "sugar," manufacturers hide the amount of sugar by listing its different sources separately, pushing each down the list. Breakfast cereal, for example, often includes some combination of sugar, brown sugar, fructose, high-fructose corn syrup, honey, and molasses—each listed separately.
10. Creative chemistry. Chemical processing evolved to extend the shelf life of products and to lower food costs. More recently, the industry has directed its creative chemistry toward increasing sensations like “mouth feel” and finding new ways to artificially simulate real flavors using flavor enhancers. It’s all about creating novelty and impact.
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