Health Spectator

Johnson & Johnson announced yesterday that it was recalling Tylenol, Motrin, and St. Joseph’s aspirin as well as other over-the-counter drugs because they emit a moldy smell that has sickened some users. The Food and Drug Administration (FDA) has criticized the New Brunswick, NJ-based company and sent it a warning letter for not taking faster action, as the problem first occurred in early 2008 and recurred less than a month ago, but little has been done by the firm to address the issue.

The New Brunswick, NJ manufacturer has agreed to stop shipping products while it investigates the problem, which apparently has been traced to a chemical used to treat wooden shipping pallets. The Associated Press is reporting that the FDA traced the problem to a facility in Las Piedras, Puerto Rico.

Products affected include both regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin. Consumers can find out exactly which batches have been recalled by going to the McNeil website. (McNeil is the division of Johnson and Johnson responsible for these products.)

These problems come not long after an FDA advisory panel recommended removing acetaminophen-containing narcotic drugs from the market last summer because of the potential harm to the livers of patients caused by acetaminophen. Acetaminophen is the active ingredient in Tylenol. That same panel recommended lowering the largest dose of acetaminophen or Tylenol from 500 mg to 325 mg.

To date, no further action has been taken and Extra Strength Tylenol—available over the counter in any drugstore—still contains 500mg of acetaminophen.

• BPA levels in canned infant formula pose higher risk than baby bottles
• Children exposed daily to untested personal-care products
• FDA reverses stance on mercury fillings
• Biologic generics move closer to reality
• meanwhile, U.S. snack food contains salmonella

• Snowboarding Glossary Continued
• Snowboarding Glossary Continued
• Johnson & Johnson expands Tylenol recall

Currently, only two anti-virals are known to be effective against H1N1 pandemic swine flu: Tamiflu (oseltamivir) and Relenza (zanamivir). If not used sparingly, these too could become ineffective, the CDC has warned.

Both drugs can be used to prevent viral infection under the right circumstances, though the protocol currently recommended by the CDC is to use these drugs in this manner only to protect pregnant women, people undergoing chemotherapy, and similar groups who are known to be at higher risk of death from swine flu.

Recently, the doctor at a camp in North Carolina decided to immunize 600 campers by using Tamiflu. The result: two girls caught swine flu anyway, and tests showed that their strain had developed Tamiflu resistance.

Tamiflu is approved by the FDA for “treatment of uncomplicated acute (mild) illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days.” The drug is also approved for prevention of influenza in patients 1 year of age and older. On August 4, 2009, the FDA commisioner released an Emergency Use Authorization (EUA) for Tamiflu because of the Public Health Emergency that was declared in the wake of the H1N1 (swine flu) epidemic.

That EUA enabled use of Tamiflu to treat and prevent influenza in patients less than 1 year of age. The EUA also allowed for use of Tamiflu at later time points (that is, in patients symptomatic for more than 2 days) and in patients sick enough to require hospitalization (severe illness).

Those seeking more information on the EUA and the current regulations surrounding the use of Tamiflu can find it on the CDC website.

• Swine flu virulence still at issue
• Australian swine flu cases rise
• WHO declares swine flu pandemic
• Goldman and Citibank get swine flu vaccine
• First U.S. citizen dies from swine flu

• Rhythms of the Season
• Warning - Swine Flu H1N1 Vaccine Is Not Safe
• Game Preview: Kentucky Wildcats vs Gators
• Perfume Scents Glossary
• What Swine Flu and Recessions Have in Common

Americans will have some serious thinking to do as the time approaches to get vaccinated against the H1N1 swine flu, which is expected to resume its ravages here in the fall.

On the one hand, judging by the flu’s sojourn in South America, it could be getting worse. It has infected turkeys in Chile, which is not a good sign. The flu could pick up virulence if it combines with one of the nastier bird flus such as H5N1, which has been making the round of flocks in Asia.

So all we need is a bit of commerce between Asia and South America—or for that matter, simply someone coming into contact with birds in both places—and we could be seeing a nastier version of the bug coming at us once the leaves are gone.

On the other hand, the vaccine itself would appear to have little to recommend it.

In America we tend to put immense faith in these meager protections offered up by the health care industry. We just assume—until proven otherwise—that flu vaccines work and are outraged when presented with evidence that they do not. And we are all the more outraged when we or one of our loved ones winds up stricken with some unforeseen illness resulting from their use, some of which can be life changing—such as Guillain-Barré, for example.

Guillain-Barré syndrome is one of those afflictions you can live without—believe me. At its most severe, it kills by paralysis—the victim is simply unable to breathe. Given prompt care (and, if indicated, the use of a ventilator) one has the possibility of full recovery—or not. Some patients end up quadriplegics, some with the partial use of their legs—it all depends. On what, no one knows.

Unfortunately, the way the game is played, at the first sign of a possible epdemic—pandemic, in this case—the Health and Human Services (HHS) Department has the option of providing incentives to drug companies for developing vaccines. There’s the rub.

In this case, HHS Secretary Kathleen Sibelius gave it all away at the first breath of national emergency: there will be no penalities for drug firms who kill or maim either with the swine flu antigen itself or with the accompanying adjuvant. Unless you can prove they deliberately tried to kill your child or loved one, you can’t touch them.

Good luck with that.

So, the full responsibility for whatever happens will be on you. No one to sue, no recourse. And unless by some miracle the Democrats grow a sense of purpose and actually push through a single-payer healthcare package, your insurance probably won’t cover the consequences, either. So you’re on your own.

Better weigh the known severity of the flu carefully before even considering that shot. Unless it starts killing a sizable percentage of those afflicted and you happen to fall into a category that is particularly vulnerable, taking a pass may be the best option.

Even if you catch the flu, chances are it will be no worse than flus you have had in the past—an unpleasant experience for several days, perhaps even a few weeks—but then, forgotten.

At present, despite seemingly high numbers, the flu has not really been all that virulent. We’ve seen 522 confirmed deaths in the U.S. as of August 20, but given more than a million estimated cases, that isn’t a huge number.

We personally have little faith in a rapidly devised vaccine for which the manufacturers aren’t willing to take full responsibility. Most of the swine flu vaccines we’re being promised will employ adjuvants (additives designed to inflame your immune system to heighten immune response) that are either already known to be dangerous or have not been approved by the FDA for regular use. They’re permitted only under the emergency provisions of HHS/FDA regulations.

So paying close attention to your diet—lots of fresh organic vegetables, wild-caught fish and pasture-grazed meats—should keep you at your best. Make sure you take adequate vitamins A, C, D, B6, magnesium, zinc and selenium. (For men especially, don’t overdue the selenium.) A healthy immune system is always your best response to the possibility of infection.

Remember that vaccines, in the end, do nothing more than use your immune system to prevent disease.

We think nature’s way of going about that may be just as good or better.

• Swine flu: no big deal for some, deadly for others
• Have U.S. swine flu infections reached 1 million cases?
• Nine dead in U.S. of swine flu
• Of vaccines, mercury, autism and Julie Gerberding
• Health care workers nix flu shots

• To worry or not..?
• Why You Catch the Flu in the Winter and Other Related Info...
• Game Preview: Kentucky Wildcats vs Gators
• What you should keep in mind about Swine-Avian-US flu
• Update About Swine Flu

A special advisory panel to the Food and Drug Administration recommended Tuesday that Vicodin and Percocet—two prescription pain-killers that combine acetominophen with narcotics—should be banned. The panel noted that prolonged use of aceominophen, which is the primary ingredient in Tylenol, causes liver damage in many patients and further recommended that at least seven other medications that combine acetominophen with narcotics should have their use discontinued.

Doctors would still be allowed to prescribe the narcotics, which include oxycodone (found in Percocet) and hydrocodone (found in Vicodin). They would further be allowed to prescribe acetominophen if they wished, but many doctors are already reluctant to prescribe medications that combine acetominophen with narcotics because of its known toxicity to the liver.

In fact, the same panel voted 24 to 13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills such as Tylenol to 325 milligrams, from the currently allowed 500 mg. They further voted 21 to 16 to reduce the maximum daily dosage of the drug to less than 4,000 mg.
(more…)

• The debate on healthcare reform
• Is swine flu vaccine an injurious jab?
• Formaldehyde linked to various cancers
• And we think we've got it bad!
• Fluoride message still not getting through

• Save Time, Money and Space in Over 80 Ways
• Simple IRA Calculator for 2009, 2010
• 3 Apple a Day Diet Review

The 1976 swine flu epidemic and consequences

• Factory farming is key to swine flu epidemic
• Chile confirms swine flu in birds
• Swine flu may be on the wane
• Nurse dies of swine flu
• Massachusetts closer to compulsory vaccinations

• Flu Season is Now Open
• Swine Flu Mask and Respirators - Effective?
• Older Adults Low on the Priority List for Swine Flu Vaccine
• National Flu Vaccination Week
• Swine flu » Blog Archive » CDC GUESSTIMATED H1N1 CASES and REFUSED ...

The U.S. Food and Drug Administration (FDA) Tuesday announced its decision that mercury amalgam fillings—the so-called “silver” fillings most Americans have in their teeth—contain insufficient mercury to warrant concern.

“While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,” the FDA website proclaims.

A national group called Moms Against Mercury, along with three other organizations, had sued the FDA in 2006 to have mercury fillings removed from the U.S. market. Later that year, an FDA panel of outside experts voted 13-7 against two statements put to them regarding the FDA’s position that mercury amalgam fillings were safe:

The panel’s rejection of these statements caused quite a flurry among pro-mercury and anti-mercury forces alike. Those opposed to the use of mercury in fillings were heartened that at last the government might be listening. The American Dental Association (ADA), which has long favored the use of mercury fillings and supported the FDA’s position, was stirred to action over the possibility that mercury amalgam might finally be banned.

According to the FDA’s website, Tuesday’s ruling was the FDA’s final word on the subject, to the disappointment of those who were hoping to have mercury banned from dental fillings because of its proven adverse health effects.

Denmark Norway, and Sweden have banned the use of mercury amalgams. Several other countries do not allow the use of mercury fillings in young people under the age of 18.

To see a video entitled “How Mercury Causes Brain Neuron Degeneration” produced by the University of Calgary Faculty of Medicine, click here.

• And we think we've got it bad!
• Real choice in health care
• FDA Panel advises banning Vicodin, Percocet
• Fluoride still not safe, despite tooth-decay data
• Honor Earth Day year 'round by eating your way to health

• Improving Health with a Superfood Diet
• Unemployed. How will my health be effected?
• The Pros And Cons Of Using Silica Cat Litter
• My Up Close Look at Health Care
• The Essence of Internet Marketing Strategies to the Growth and Success of your Online-based Business. Helpful Things to Bear in Mind

In what came as a surprise move, the House passed a sweeping food safety reform bill a day after defeating a previous version. House Democrats kept revising the bill until they got it right. The previous version would have placed onerous burdens on small farmers and small food producers.

The version that passed the House today exempted these groups so long as they are selling their good directly to consumers, retailers and restaurants. When selling to wholesalers, however, they are covered by the same rules and restrictions as larger producers. That is, they are required to pay an annual $500 registration fee and to maintain a track-back system that identifies lots of food and their origins.

If passed by the Senate, the bill would require all facilities to have a food safety plan in place, would give the Food and Drug Administration the power to order food recalls, and would expand FDA access to company records.

Supporters of the bill say it will enable the Food and Drug Administration (FDA) to prevent food contamination through increased inspection of large food-preparation facilities. More than 76 million Americans fall sick every year from food-borne illnesses, while 5,000 of those die.

Under the bill, inspections would take place every six to 12 months at high-risk facilities and every three years at lower-risk plants.

Currently, plants may go years without an inspection.

• Food contamination still afflicts China and US…
• A few words from Barbara Kingsolver, author of Animal, Vegetable, Miracle: A Year of Food Life
• And we think we've got it bad!
• Children exposed daily to untested personal-care products
• Massachusetts closer to compulsory vaccinations

• Cut Your Grocery Bill With A Cookbook And Some Real Food.
• Who's Writing These Bills Anyway?
• Housing Update
• Senate health care vote: a defining moment
• Reduce your debt with person to person loans?