Everything You Read...

There's an old saying that goes something like this: "You can't trust everything you read."

With the proliferation of Big Pharma ads flooding mainstream media these days, it might get a wee bit harder for all of us to sift through the "facts" about various medications and their intended use. And now, the FDA has drafted new guidelines that could make the decision for doctors -- on what pill to give when -- all that more difficult...

You see, back in 2003, a New York Times report came out that detailed a criminal and civil investigation of a drug company.

Court documents showed that company officials hired a marketing firm to write medical journal articles that placed their drug in a positive light. The company paid $12,000 for each article and an additional $1,000 to various doctors who agreed to allow their names to be listed as "authors." Salespeople then distributed the phony articles to doctors to persuade them that the drug was safe and effective for off-label use.

If you're into detail, here's an interesting read.

Just so you know, back in the late 90s a law was passed allowing drug reps to share peer-reviewed articles with doctors.

But back then there were two conditions:

1. Copies of the articles had to be submitted to the FDA, and
2. A drug company that submitted an article had to promise to begin the process of seeking FDA approval for the off-label use of the drug.

In other words, before the drug company could send the article out to doctors, they would also have to "prove" their drug could meet the "new use" implied in the peer-reviewed articles by conducting their own efficacy tests for the new use.

That previous law lapsed a couple of years ago, and since then the issue about sharing articles has been in limbo.

But a new draft guidance seeks to establish clear guidelines, AND those two annoying (for Big Pharma) requirements have been dropped. No more bothering with sending copies of articles to the FDA, and no more promises to mount studies to examine little details like efficacy and safety.

According to a New York Times report, one FDA representative confides that "the agency did not really enforce those requirements anyway."

If you read our "Drugs in our Water" article the other day and checked out the AP news release, you might have read this quote:

Over the past five years, the number of U.S. prescriptions rose 12 percent to a record 3.7 billion, while nonprescription drug purchases held steady around 3.3 billion, according to IMS Health and The Nielsen Co.

With this new "guideline" I'm guessing the sales for presecription drugs are going to skyrocket to new and much higher heights.

Drugs in our Drinking Water

In the course of a five-month inquiry, the Associate Press announced that drugs have been detected in the drinking water supplies of 24 major metropolitan areas -- from Southern California to Northern New Jersey, from Detroit to Louisville, Ky -- the drinking water supplies of at least 41 million Americans. (read story here)

What kind of drugs?

A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones...

Although the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, and in most instances fall far below the levels of a medical dose, there's still cause for alarm among scientists worried about the long-term consequences to human health.

The USA EPA has actually been aware of the problem for some time, both from the human prescription drugs leaching into water supplies as well as those drugs flowing into water resources as a result of algricultural practices.

They had this to say in the Fox news report on the subject:

"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency.

Some think the EPA is only doling out lip service. In fact, the EPA's recent move to "water down" the effects of large factory farm manure spreading has recently earned them a black eye from certain watchdog groups. You can see the "request for public comment" on the issue here.

Think the water problems are just in the USA? Think again...

For example, in Canada, a study of 20 Ontario drinking water treatment plants by a national research institute found nine different drugs in water samples. Japanese health officials in December called for human health impact studies after detecting prescription drugs in drinking water at seven different sites.

You can read the full article here.

Your Circadian Rhythm

Daylight Savings Time means pushing the clocks ahead in spring for many of us. If you're feeling a bit "out of sorts" following this tradition, it could be owing to your circadian ryhthm.

What is Circadian Ryhthm?

Wikipedia defines it as:

A circadian rhythm is a roughly-24-hour cycle in the physiological processes of living beings, including plants, animals, fungi and cyanobacteria.

In other words, it's your internal body clock that keeps on ticking to its own beat.

Circadian rhythms are an intrinsic part of many body systems and processes -- even ones that don't seem to have anything to do with sleep. Although research into this area of health is relatively new, scientists are already discovering that disruptions in our normal 24-hour cycles, such as turning the clocks ahead by one hour, can lead to all sorts of seemingly unrelated problems.

What can Happen when our Circadian Ryhthm is Disrupted?

One recent study found that circadian rhythms (CR) play a key role in metabolism and weight gain, however the most common side effect is insomnia.

As CR plays an important role in determining the sleeping and feeding patterns of all animals, including human beings -- clear patterns are emerging of other functions of CR, including determining of core body temperature, brain wave activity, hormone production, cell regeneration and other biological activities linked to this daily cycle.

When you tamper with your day/night, it may take time for your internal clock to adjust.

Tips for Easing into your new Circadian Rythm

Think you're going to beat your CR into submission after changing the clocks? Think again... It's actually best, if you can't sleep, to ease yourself into the new rythm. If you can't sleep, try avoiding caffeine, nicotine, and alcohol, especially at night. Also, create a restful environment prior to sleep time, with soft music, maybe a warm bath... it all helps.

Happy Daylight Savings Time!

OECD report reveals growing counterfeit problem

Kiwis, conserved vegetables, milk powder, butter, ghee, baby food, instant coffee, alcohol, drinks, confectionery, and hi-breed corn seeds are among the most counterfeited articles in the world according to a new report from the Organisation for Economic Co-Operation and Development (OECD), to be published this June.

“Trade in counterfeit goods is a big problem and getting bigger,” said John Dryden, Deputy Director of the OECD’s Science, Technology and Industry Directorate. “It is pervasive, it involves some pretty unsavoury and ruthless characters, and it has serious implications for health, safety, living standards and jobs. It is also a major disincentive to invent and innovate.”

The market for counterfeit and pirated products can be divided into two important sub-markets. In the primary market, consumers purchase counterfeit and pirated products believing they have purchased genuine articles. The products are often sub-standard and carry health and safety risks that range from mild to life-threatening. In the secondary market, consumers looking for what they believe to be bargains knowingly buy counterfeit and pirated products.

...In the food and drink sector, few people would knowingly purchase counterfeit food or drink products, due in part to the potential health risks involved. Such risks range from general discomfort, to serious illness and even death. As discussed in the sectoral assessment, this has been the case for poorly distilled raw spirits and fake baby formula.

The OECD report makes a number of recommendations for ways to address the issues and calls on governments to clamp down. Click to view the Executive Summary (pdf format) of the report online.

Tainted Pet Food Reaches Pork

In our earlier story about tainted pet food, we mentioned the concern some experts had about the melamine-tainted wheat gluten entering our food supply. This concern was expanded to a rice protein, also imported from China. According to AOL News today, this may have happened -- not directly, but indirectly through pork. (link)

WASHINGTON (April 26) - Several hundred of the 6,000 hogs that may have eaten contaminated pet food are believed to have entered the food supply for humans, the government said Thursday. The potential risk to human health was said to be very low.

In the state-by-state breakdown of potential hogs contaminated, it's the South Carolina investigation which caught my attention:

SOUTH CAROLINA: Urine tests done on some of the 800 hogs now quarantined at a farm have tested positive for low levels of melamine. None went to slaughter. According to the state veterinarian, none of the suspect feed was fed to the hogs. Federal tests on the feed have come up negative. The positive urine tests could not be immediately explained, although contaminated feed could have escaped detection during tests, the FDA said.

If they did not eat the tainted pet food in question, then one has to wonder how melamine could have gotten into this group of hogs.
CLEMSONews indicated;

The potentially contaminated feed was bought as salvage pet food from Diamond Pet Foods Inc., which received contaminated wheat gluten and rice protein concentrate from China. ...State officials are waiting for guidance from the FDA, FSIS and EPA as to the significance of these tests and other pending tests.

Livestock and Poultry Health is a unit of Clemson University Public Service and Agriculture. The agency inspects and regulates the state meat and poultry industries.

Pathogens Transmitted Commonly Through Food

The USA Centers for Disease Control and Prevention published a new report last week that reveals startling deficiencies in food safety. For examples, there has been a 50 percent increase in E coli infections since 2004, and a whopping 78 percent increase in Vibrio infections (generally caused by eating raw shellfish) over the past decade.

Progress was made against rising cases of food contamination through consumer education, where the USDA and other Government entities promoted fully cooking of meat products (such as sea food, poultry, eggs, and beef) and thoroughly washing surfaces that came into contact of such raw produce.

BUT, the huge outbreaks associated with spinach, lettuce, tomatoes and peanut butter that have occurred over the last 6 months suggest the battle for reducing foodborn illnesses is losing ground. The problem has spread to foods that are commonly eaten raw.

As important as it is to detect contamination and quickly pull such products from the market ...it is equally important -- MORE important in my humble opinion -- to prevent contaminations at the source.

As BeverageDaily writes, "...an absolute priority needs to be better systems for prevention."

Voluntary guidance or industry self regulatory schemes is a short sighted answer to a growing problem that calls for immediate and permanent solutions, according to Consumers Union...

ConAgra [in response to the Peter Pan Peanut Butter contamination responsible for at least 4 deaths] said it "had plans in place to address this kind of situation". Now the firm is totally renovating and redesigning its plant to separate raw ingredients from finished products, as well as appointing a Global Food Safety executive and forming a Food Safety Advisory Committee.

These are all positive moves, it's just a shame they needed to be prompted by disaster. Learning from mistakes is good, but preventing them is even better.

Salmonella infections cause an estimated 1.4 million human illnesses and 400 deaths annually in the United States, according to the CDC. In total, the CDC estimates that 76 million Americans get sick and 5,000 die from foodborne hazards each year in the United States.

Sources:

CDC Report (link): "Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food --- 10 States, 2006"

BeverageDaily (link): "Food contamination: time for action"

CDC Report (link): "Multistate Outbreak of Salmonella Typhimurium Infections Associated with Eating Ground Beef --- United States, 2004"

Taste Test for Smokers

"With a few modifications to their diet - consuming items that make cigarettes taste bad, such as a cold glass of milk, and avoiding items that make cigarettes taste good, like a pint of beer - smokers can make quitting a bit easier," says Dr Joseph McClernon, lead researcher on a new study that was conducted by researchers at Duke University Medical Center.

Overall, dairy products (such as milk or cheese), non-caffeinated beverages (such as water or juice), and fruits and vegetables were found to worsen the taste of cigarettes, by 19 percent, 14 percent and 16 percent of respondents respectively.

Forty-four percent of participants reported that alcoholic beverages enhance the taste of cigarettes; 45 percent reported caffeinated beverages, such as tea, cola and coffee; and 11 percent reported meat.

If you've been looking for ways to kick the habit, you might want to consider a few changes to your menu plan. Visit this link for more details on this new report.