You would think that a developed nation with the size, strength and clout of the United States of America would excel at the basic provision of clean drinking water for its citizens. Indeed, when Americans see images of under-developed countries around the world, with residents having to grapple with filthy sources of water for drinking, washing and bathing—our hearts go out to them.
Little do most Americans know that such images hit just a little closer to home.
The Clean Water Act passed in 1972 was an attempt to upgrade the nation’s aging sewer system. Over two decades in the 1980s and 1990s more the $60 billion was distributed by Congress to various cities and municipalities around the country in an attempt to shore up antiquated sewers.
But it doesn’t seem to have helped. According to a recent New York Times investigation, sewers around the country are frequently overwhelmed resulting in raw sewage spilling into waterways.
In the last three years alone, according to the Times investigation, more than 9,400 of the 25,000 sewage systems that exist in the US have reported violations via the dumping of Read the rest of this entry »
They’re easily the hottest item on children’s wish list this year: The Zhu Zhu Hamsters. Every kid wants ‘Chunk,’ or ‘Pipsqueek,’ or ‘Num Nums’ under the tree this year. They are the 2009 version of Tickle-Me-Elmo, or the Cabbage Patch Dolls of years gone by. They’re not expensive, retailing for $8 to $10 each. But that’s if you can find them. There’s been a rush to buy them, the US-based manufacturer has cranked up production in China and opportunists—sensing a wave—have bought them up by the box load and have put them up on eBay selling for up to four or five times what they’re worth at retail.
Little wonder. Did I mention Tickle-Me-Elmo? When your kid wants something sooooooooo badly, and between you and Santa nary a Zhu Zhu can be found, the internet may be your only savior. And there’s no price too high to delight your little girl, or boy Christmas morning.
The big difference between the Tickle-Me-Elmo phenomenon and this time was the allegation from a consumer watchdog that the Zhu Zhu hamsters are unsafe. GoodGuide, a not-for-profit group with ties to the University of California at Berkeley, rocked the must-have toy world last Friday with allegations that testing done on ‘Mr. Squiggles,’ the light-brown member of the Zhu Zhu quartet, Read the rest of this entry »
The Zicam issue brings to the fore yet another issue involving the mandate of the US Food and Drug Administration (FDA), the federal health regulator that has jurisdiction over medical devices and medical drugs—and food. A wieldy mandate indeed and one that, due to funding and staffing issues, the agency has been hard-pressed to undertake effectively.
That said, naturopathic products, natural-health potions and homeopathic elixirs do not fall under the FDA’s regulatory mandate for approval.
Given the growing popularity of homeopathic products, the FDA’s mandate should be expanded.
“Many of our clients believed the FDA had evaluated Zicam before it reached the market,” said lawyer Robert Gordon, a partner with the New York law firm Weitz & Luxenberg. “In fact, Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural ingredients. Mounting evidence from the scientific community is proving Zicam with zinc should never have been sold. Some trusting users are now paying a price with their health.”
The status quo only confuses the public. To be fair, nowhere on the labels for products such as Zicam does it say that the product carries FDA approval. And yet, when there is a problem with a product—homeopathic or otherwise—which agency undertakes the issue of the health alert?
The FDA. The latter is also involved in the negotiation and co-ordination of voluntary product recalls—as it was for Zicam—for products the FDA was not required to approve. That, together with the blurring of the lines between what is medicinal and what isn’t, leaves Joe Q. Public at a loss to explain just who is running the show.
The same holds true for dietary supplements and other weight-loss remedies that use natural ingredients. If it’s homeopathic, then a product does not have to satisfy the FDA before it goes to market.
But here’s the rub: various medicinal ingredients, either on their own or in concert with other ingredients, can elicit side effects and other dangerous risks. Hence the requisite testing required of the manufacturers, with the subsequent vetting through the FDA before the product is approved for sale.
However, just because an ingredient is listed as ‘natural’—a mineral, herb or otherwise—doesn’t automatically suggest it is safe. Natural products can hurt you too, if used in the wrong way and in misguided combination with either another product or in association with an incorrect indication.
People who have used Zicam nasal spray for colds have reported a loss of their sense of smell. Sometimes it is immediate. For others the loss occurred after prolonged use. Some had their sense of smell return after they stopped using Zicam. Others are fearing that their smell loss (and concurrent loss of the ability to taste food) may be permanent, and lawsuits have been launched.
All, because of zinc. Zinc on its own has a benefit to the human body. It’s actually integral, in proper balance with copper, to maintaining a healthy system. However, zinc up the nose is apparently a problem, as various studies and a flood of reports to the FDA now show.
Would this have happened, had this product been required to go through the rigorous FDA approval process?
The FDA is under the gun due to the perception of lax oversight. The agency’s critics cite too many close ties, funding and otherwise, with pharmaceutical companies that only serves to cloud its objectivity. Defenders of the FDA cite the fact that the agency has suffered through years of chronic under-funding and staff shortages and thus cannot hope to cope with a regulatory environment that now sees drugs and medical devices increasingly manufactured offshore.
And now this.
The FDA needs to promote to the American consumer that it does not have jurisdiction over homeopathic products—at least at the approval stage—and therefore the consumer cannot assume that a homeopathic product he is buying comes with the FDA stamp of approval.
Either that, or Congress needs to provide a massive funding and staffing boost to the FDA in order to undertake its current mandate, together with the adoption of a new mandate to regulate the homeopathic industry.
The FDHA—the US Food, Drug and Homeopathic Agency.
Has a nice ring to it.
Fort Lauderdale, FL: A landmark ruling by a jury in Fort Lauderdale late Thursday could set the stage for additional personal injury lawsuits after a Florida woman was awarded $300 million in a tobacco lawsuit. Provided the verdict survives an assumed appeal by defendant Philip Morris, the award represents the largest single award to an individual suing a tobacco company.
Lucinda Naugle was 20 when she started smoking, a habit she maintained for 25 years before finally quitting at the age of 45. Now 61, Naugle suffers from severe emphysema and requires a lung transplant she can’t afford.
If she lives long enough to see an end to the appeal process, Naugle would have more than enough to fund her surgery. The sister of a former Fort Lauderdale mayor was awarded $56 million in compensatory damages and $244 million in punitive damages. Following three hours of deliberation after a three-week trial, the jury assessed liability to Naugle at 10 percent, whereas Philip Morris was saddled with 90 percent.
Altria Group, the parent company of Philip Morris based in Virginia, indicated that it would appeal the verdict. A spokesperson called the Florida rules “fundamentally unfair and unconstitutional.”
Lawsuits against tobacco companies are not unique, especially since 1998 when the seven largest tobacco companies agreed to fork over $206 billion in a master settlement agreement with 46 states.
Florida was one of those states. However, what sets Florida apart is a major legal ruling three years ago that makes it easier for individuals to sue tobacco companies, by way of the lowering of the burden of proof.
In 2006 the Florida Supreme Court rejected a class-action verdict and an award totaling $145 billion to plaintiffs, stating that plaintiffs would have to litigate individually. However-and this is the important caveat-the court dictated that plaintiffs would not be required to prove some key elements that had been upheld in the first stage of the class action: namely that nicotine is addictive, that smoking causes diseases and that cigarette companies fraudulently withheld those facts.
“That makes Florida unique,” said Clifford Douglas of the University of Michigan Tobacco Research Network, in comments published yesterday in the New York Times.
Naugle’s legal counsel told the New York Times that 25 additional cases would go to trial in Florida next year. In all, more than 9,000 people from the former class action have filed individual lawsuits in various Florida courts. Approximately 4,000 of those cases were filed in federal court and have been stayed pending a review scheduled for early next year.
A tobacco analyst for Morgan Stanley said that the tobacco industry could afford several hundred million dollars a year in legal losses. “That is a financially manageable issue,” David Adelman said.
They fall all over themselves to make sure you have a good time. But they might not be doing the one thing that would pretty near guarantee you one:
Cleaning the public restrooms. And the problem with a gastrointestinal outbreak on a cruise ship is that you’re often thousands of miles in the middle of nowhere.
Make no mistake—compared to other bathrooms of the world, cruise ship bathrooms appear to be sparkling. I’ve been in them. So have you. And compared to the bathroom at the airport, or at the restaurant where you had dinner before your flight to meet the ship, cruise ship rest rooms appear to be so clean you could eat off the floor.
Well, almost. But not quite.
The problem is the pesky norovirus, which is a tough old bird that survives on just about anything for weeks at room temperature. And you know those alcohol-based hand sanitizers Read the rest of this entry »