Wednesday, March 12, 2008

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But a new draft guidance seeks to establish clear guidelines, AND those two annoying (for Big Pharma) requirements have been dropped.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.

Tuesday, March 11, 2008

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.

Monday, March 10, 2008

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!