Drug Updates

Lipitor Recalled (webmd)

Dec. 21, 2010 — The Lipitor recall continues with Pfizer’s recall of 19,000 more bottles of the popular cholesterol drug.

A musty smell has led to four recalls, totaling 345,000 bottles since August 2010.

The latest recall is dated Dec. 17 on Pfizer’s web site. The 19,000 bottles represent a single lot of Lipitor. Pfizer says one customer complaint spurred recall of the entire lot.

The bottle’s musty odor comes from TBA, a chemical used to treat the wooden pallets on which the product was stored. Pfizer says the smelly bottles were supplied by a third-party bottle manufacturer, and that the company prohibits use of TBA-treated wood to ship its medicines.

According to the FDA, people can detect the odor of TBA even when the chemical is present in extremely tiny amounts. Although nobody really knows whether TBA can be toxic — studies are few and inconclusive — the FDA concludes that “health risks appear to be minimal.”

However, some people have reported “gastrointestinal events” because of the foul odor or taste of the drug stored in bottles contaminated with trace amounts of TBA.

Pfizer is not the only drug company affected by musty packaging. TBA in storage pallets is blamed for recent recalls of Johnson & Johnson’s Tylenol.

All of the recalled bottles contain Lipitor 40 milligram tablets. The lot number of the current recall is 0836050.

Statin Side Effects (webmd)

The most common statin side effects include:

  • headache
  • difficulty sleeping
  • flushing of the skin
  • muscle aches, tenderness, or weakness
  • drowsiness/ weakness
  • dizziness
  • nausea and/or vomiting
  • abdominal cramping and/or pain
  • bloating and/or gas
  • diarrhea
  • constipation
  • rash

Which Statin Side Effects Are Serious?

Myositis, which is inflammation of the muscles, can be a side effect of statins. The risk of muscle injury increases when certain other medications are coupled with statin use. For example, if you take a combination of a statin and a fibrate — another cholesterol-reducing drug — the risk of muscle damage increases greatly compared to someone who takes a statin alone.

Rhabdomyolysis. Muscles all over the body become painful and weakened because of extreme muscle inflammation and damage. CPK levels are extremely elevated as well. The kidneys can become overworked trying to eliminate a large amount of muscle breakdown caused by statin use.

Caution with Avastin for Breast Cancer

The Effectiveness of Chemo (Clin Oncol (R Coll Radiol). 2005 Jun;17(4):294.)

Abstract

AIMS: The debate on the funding and availability of cytotoxic drugs raises questions about the contribution of curative or adjuvant cytotoxic chemotherapy to survival in adult cancer patients. MATERIALS AND METHODS: We undertook a literature search for randomised clinical trials reporting a 5-year survival benefit attributable solely to cytotoxic chemotherapy in adult malignancies. RESULTS: The overall contribution of curative and adjuvant cytotoxic chemotherapy to 5-year survival in adults was estimated to be 2.3% in Australia and 2.1% in the USA.

CONCLUSION: As the 5-year relative survival rate for cancer in Australia is now over 60%, it is clear that cytotoxic chemotherapy only makes a minor contribution to cancer survival. To justify the continued funding and availability of drugs used in cytotoxic chemotherapy, a rigorous evaluation of the cost-effectiveness and impact on quality of life is urgently required. PMID: 15630849

A Link Between Diabetes and Inhaled Steroids (Webmd)

For the study, which is published in the November issue of The American Journal of Medicine,  Suissa and his colleagues analyzed the drug records of more than 388,000 patients who were prescribed inhaled corticosteroids in Montreal from 1990 to 2005. 

They found that the risk of needing medication to control high blood sugar increased about 34% in patients taking any dose of daily inhaled corticosteroids. In those on the highest doses, the risk increased by 64%.  The study also found that inhaled corticosteroids were associated with an increased risk of needing stronger medications to control blood sugar, an indication that diabetes could be worsening in those who already have it.

While a 34% increase in risk may sound alarming, experts point out that the absolute numbers are still very small. For example, the number of people who were diagnosed with diabetes each year rose from 14 out of 1,000 to 20 out of 1,000 in people taking inhaled corticosteroids.

The Effectiveness of the Flu Vaccine (Abstracts on Pubmed):

Am J Respir Crit Care Med. 2008 Sep 1;178(5):527-33. Epub 2008 Jun 12.

CONCLUSIONS: The 51% reduction in mortality with vaccination initially observed in patients with pneumonia who did not have influenza was most likely a result of confounding. Previous observational studies may have overestimated mortality benefits of influenza vaccination. PMID: 18556629 [

Arch Pediatr Adolesc Med. 2008 Oct;162(10):943-51.

OBJECTIVE: To measure vaccine effectiveness (VE) in preventing influenza-related health care visits among children aged 6 to 59 months during 2 consecutive influenza seasons.
DESIGN: Case-cohort study estimating effectiveness of inactivated influenza vaccine in preventing inpatient/outpatient visits (emergency department [ED] and outpatient clinic). We compared vaccination status of laboratory-confirmed influenza cases with a cluster sample of children from a random sample of practices in 3 counties (subcohort) during the 2003-2004 and 2004-2005 seasons.
SETTING: Counties encompassing Rochester, New York, Nashville, Tennessee, and Cincinnati, Ohio.
 
 
 
 
 

 

 

 

CONCLUSION: In 2 seasons with suboptimal antigenic match between vaccines and circulating strains, we could not demonstrate VE in preventing influenza-related inpatient/ED or outpatient visits in children younger than 5 years. Further study is needed during years with good vaccine match. PMID: 18838647

Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004879.

 

 

 

 

 

 

 

 

AUTHORS’ CONCLUSIONS: Influenza vaccines are efficacious in children older than two years but little evidence is available for children under two. There was a marked difference between vaccine efficacy and effectiveness. That no safety comparisons could be carried out emphasizes the need for standardisation of methods and presentation of vaccine safety data in future studies. It was surprising to find only one study of inactivated vaccine in children under two years, given recent recommendations to vaccinate healthy children from six months old in the USA and Canada. If immunisation in children is to be recommended as public-health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required.

PMID: 16437500 [PubMed – indexed for MEDLINE]

 

 

 

 

 

 

 

 

 

Antiboitic Resistance: an unmentioned culprit (FDA)

Antibiotic Resistance is a growing concern. Recently, AMA recommended not to prescribe antibiotics routinely unless absolutely necessary. But, what about using anti-microbe agents to make up for unsanitary conditions in our food? What if we are eating antibiotics, and not even considering this as a primary factor?

Nutrigenomics & Supplements

Berries Boost the Brain Health (Vitalchoice)

Human diets rich in blueberries have previously been linked to a reduced risk of Alzheimer’s, and the berries’ benefits are believed to flow from their polyphenol content … in particular, two kinds found in most berries, called anthocyanins and flavanols.

 

We still don’t know how anthocyanins and flavanols might enhance memory and other brain functions … but in rats, they’re proven to cross the blood-brain barrier and reach areas associated with cognitive performance (Andres-Lacueva C et al. 2005).

Berries Also Bust Blood Sugar Issues (Vital Choice Newsletter)

The researchers speculated that the health association between higher intake of food-borne polyphenols and healthier blood sugar levels might be due to the ability of these compounds to reduce oxidative stress from free radicals (unstable oxygen compounds).
 
Recent studies suggest that oxidative stress promotes diabetes. In fact, the pancreatic islet cells that produce insulin have low levels of free-radical quenching enzymes, making them particularly susceptible to oxidative stress.
 
We also know that inflammation and oxidative stress are interrelated, and the Greek scientists also noted that participants with lower antioxidant intakes had higher levels of inflammation-related chemicals in their blood.
 
And in a prior study, the same Greek team found that ATTICA study participants with high antioxidant capacity in their blood (due to polyphenol intake) had higher levels of a hormone called adiponectin.
 
Higher adiponectin levels are generally associated with reduced accumulation of pro-inflammatory abdominal fat.

 

Health

California Bans Mercury Fillings in Dentistry (Mercola)

The two videos above are from the October 19, 2010 Costa Mesa City Council meeting, during which the Monahan Resolution banning the use of dental mercury was enacted.

The FDA has long been the world’s number one protector of mercury fillings, and the U.S. is lagging behind the rest of the world, and even behind some third world countries, in protecting its citizens from this toxic product:

  • Canada advised dentists to stop placing amalgam in children and pregnant women in 1996!
  • Denmark, Norway and Sweden have essentially banned amalgams.
  • There are 5,636 hospitals in developing countries that are committed to or already mercury-free. The majority of these are in the Philippines, India and Argentina.

When to Exercise & Should you Snake Before (J of Physiology)

One study says no and no. But…listen to your body…

Abstract

A fat-rich energy-dense diet is an important cause of insulin resistance. Stimulation of fat turnover in muscle cells during dietary fat challenge may contribute to maintenance of insulin sensitivity. Exercise in the fasted state markedly stimulates energy provision via fat oxidation. Therefore, we investigated whether exercise training in the fasted state is more potent than exercise in the fed state to rescue whole-body glucose tolerance and insulin sensitivity during a period of hyper-caloric fat-rich diet. Healthy male volunteers (18-25 y) received a hyper-caloric (?+30% kcal day(-1)) fat-rich (50% of kcal) diet for 6 weeks. Some of the subjects performed endurance exercise training (4 days per week) in the fasted state (F; n = 10), whilst the others ingested carbohydrates before and during the training sessions (CHO; n = 10). The control group did not train (CON; n = 7). Body weight increased in CON (+3.0 ± 0.8 kg) and CHO (+1.4 ± 0.4 kg) (P < 0.01), but not in F (+0.7 ± 0.4 kg, P = 0.13). Compared with CON, F but not CHO enhanced whole-body glucose tolerance and the Matsuda insulin sensitivity index (P < 0.05). Muscle GLUT4 protein content was increased in F (+28%) compared with both CHO (P = 0.05) and CON (P < 0.05). Furthermore, only training in F elevated AMP-activated protein kinase ? phosphorylation (+25%) as well as up-regulated fatty acid translocase/CD36 and carnitine palmitoyltransferase 1 mRNA levels compared with CON (?+30%). High-fat diet increased intramyocellular lipid but not diacylglycerol and ceramide contents, either in the absence or presence of training. This study for the first time shows that fasted training is more potent than fed training to facilitate adaptations in muscle and to improve whole-body glucose tolerance and insulin sensitivity during hyper-caloric fat-rich diet. PMID: 20837645

The Uniqueness of Each Individual-Exercise for your Bloodtype (D’Adamo Newsletter)

Here are some Blood Type specific workout tips from Des.

Blood Type O – I prescribe heavy lifting and anything where they can do short bursts of extreme energy. For cardio, lift lighter weights without letup for a 15 minute burst. I work them as hard as they can and then break for a few minutes.

Type O sample workout:

For exercise that tones, try circuit training. It’s an amazing form of cardio that combines calesthetics and weight lifting and keeps your heart pumping hard the whole time. The more exercises you can string together, the better. Use light to medium weights. Learn to keep your heart rate up and you will find that you can easily cut down lots of body fat that will be noticeable right away. Be sure to eat lots of beneficial food after these workouts or you will find yourself wanting to crash and sleep for an hour afterwards.

An example of a circuit would be:

  • Body weight squats (You may add a dumbbell or two or a barbell if you’d like to make it more difficult.)
  • Pushups
  • Bicep curls – 24 reps

Take a 2 minute break then start over.

It is rarely intense enough for blood type O’s, but that doesn’t mean that you don’t need a break from time to time, particularly when it comes to heavy weight lifting. When you want to get more weight up, be sure to stay very hydrated, have many meals throughout the day and when you are lifting, take the extra time for those breaks and you’ll find that you are able to get a bit more weight up on that next set.

Blood Type A – The major focus here is STRESS MANAGEMENT. I give blood type A’s the kettle bells, boxing, simulated martial arts and so on. If they are on their own, gardening and carpentry also work miracles. That makes up their cardio and strength training. On lighter days, I keep it mostly to core work and bodyweight movement with some light running involved.

Type A sample workout:

I find that boxing, slow body weight exercises that involve focused breathing (yoga, tai chi, etc.) and kettle bells are some of the best ways to help a blood type A focus while burning lots of calories. It seems that the more you are able to concentrate on the “task at hand” the easier it is to cope with your stress levels. Boxing, yoga, tai chi, and kettle bells can have a very large impact on the posture of your body, check with a personal trainer for using proper form to avoid injury.

Another idea is to do some house work, construction, help someone move or some intense garden work. If you find that your exercises have been exhausting you, perhaps it is time to slow down and quiet your mind.

Blood Type B – This depends on their GenoType quite a bit. If they are a Gatherer, I’ll stick mostly to balance work and keeping them centered and focused. That keeps the pain down and allows them to burn lots and lots of calories. My favorite activity for other B’s is to take them out on a long, slow bike ride for two or three hours – after the ride is over, I swear it looks like they just did full-body liposuction!

Type B sample workout:

  • 20 mile bike ride
  • Elliptical machines – 45 minutes on a random setting
  • Standing tricep extensions, bicep curls, shoulder presses on one foot – 25 lb. dumbbells (for men) or 10 lb. dumbbells (for women), keep the repetitions above 15 times for each arm to tone out. Lift one leg off the ground and continue doing these exercises.
  • Stand on the Bosu Ball or some other unstable surface with one leg (weights not needed, but they do make it more fun).

Keep the balance work as intense as possible. I believe that everyone should do balance work, but it seems to have a much larger effect on blood type B’s than the rest of us. Typically a blood type B who is following these exercise suggestions will feel very good and energized after these workouts.

Blood Type AB – I haven’t had as much experience with this blood type. I am still learning about them, after all, they are the rarest blood type! But I’ve found that almost anything but heavy lifting seems to suit them well.

Type AB sample workout:

Combining the mental clarity of a Type A and the Balance of a Type B is the way of the AB.

One day, you might do yoga, the next go for a long bike ride, the following day practice some Tai Chi, perhaps followed with some light boxing or preferably martial arts and the next day go into the gym and do standing tricep extensions with a very slow and controlled pace. The goal is to not make it too intense. Keep it balanced, moderate and breathe with every movement.

Focused breathing techniques to quiet your mind and focus you before some balance work is a great way to center yourself and prepare your body for what is to come. Finish off your exercise with stretching and breathing to calm your body and relax your mind.

Visualizing Change in the New Year (Dr. Northrup)

  • Healing always involves releasing the past as we move into the future. If we don’t release the past, we keep re-creating it—and it becomes the future. As we release, it’s also crucial to have a powerful vision of a hopeful and exciting future that draws us forward. For years, I had my patients begin their health journeys by exploring their pasts to find clues to how they were creating their present conditions.
  • Our cells keep replacing themselves daily, and we create whole new bodies every seven years. So it is not really accurate to say that our pasts are locked in our bodies, though sometimes it seems that way. What is really going on is that the consciousness that is creating our cells is often locked in the past—and that consciousness keeps re-creating the same old patterns via old subconscious nervous system programming. If, however, we can change the consciousness that creates our cells, then our cells and lives improve automatically, because health and joy are our natural state. The easiest and fastest way to do this is to imagine your future self in as much detail as you possibly can. Doing this will assist you through any healing process you’re currently involved in. So before you dive into any resolutions, invite your future vision to accompany you on your journey. If you were in optimal health and truly flourishing, what would your life look like?
  • This question may be answered in the form of an exercise, with a friend who fully supports you; in writing, without worrying about revising or spelling; or out loud to yourself as you look in a mirror.
  • Answer the following questions (have your friend ask you the questions one by one, or write for three to five minutes without stopping, or talk to your image in the mirror):
  • If anything at all were possible, quickly, easily, and now, what would your life look like? 
  • Who would be in it? 
  • What would you be doing? 
  • Where would you be living? 
  • What would you feel like? 
  • What would you look like? 
  • How much money would you be making?

Top Ten Bone Health Wishes for 2011 (BetterBones)

My 2011 wish list:

1. Women all over this country will gain increasing confidence in their bone health.
Not so easily frightened by a low bone density reading, women will ask two vital questions before taking bone drugs: (1) Am I really at high risk of fracture? and (2) What can I do to naturally increase the strength of my skeleton?

2. People in their 30s will begin osteoporosis prevention programs.
Can word trickle down to younger generations that bone loss begins much earlier than expected (in the 20’s and early 30’s), so that wise people can take note and take action? 

3. This proverb will be scientifically validated:  A merry heart is like a medicine, but a broken spirit dryeth the bones
Scientists will document with hard data that happiness and a general feeling of well-being are two of the most important factors influencing bone health.

4. Multi-nutrient therapy will become the rule rather than the exception.
Physicians and the general public at large will become aware of the role many nutrients (not just calcium and vitamin D) play in bone health.  Those looking to build bone strength naturally and even those given bone drugs will be told to supplement with the full 20 bone-building nutrients

Can’t Sleep? It may be your Computer or TV! (Dr. Mercola)

Your circadian rhythm has evolved over many centuries to align your physiology with your environment. However, it is operating under the assumption that you’re still behaving as your ancestors have for generations: sleeping at night and being awake during the day.

If you push these limits by staying up late at night, depriving yourself of sleep, or even eating at strange hours (such as at 2 a.m.), you are sending conflicting signals to your body. As a result, you body doesn’t know whether it should be producing chemicals to tell you to go to sleep, or gear up for the beginning of your day.

But maintaining this natural circadian rhythm affects far more than just your sleep pattern. Your body actually has many internal clocks — in your brain, lungs, liver, heart and even your skeletal muscles — and they all work to keep your body running smoothly by controlling temperature and the release of hormones.

Your body temperature and hormone production also vary with your personal internal clock. This, in turn, influences such things as:

  • The easiest time to detect disease in your body
  • The times when you’ll be less sensitive to pain
  • The times when you’ll be more productive at work 

Disrupting your natural rhythm can also make you more vulnerable to disease. For example, reduced melatonin levels, due to prolonged exposure to light, is known to increase your risk of cancer.

Naturopathic CNME to Get 5 Year Approval (Integrative Practicioner, John Week’s Update)

Dan Seitz, JD, EdD, executive director of the Council for Naturopathic Medical Education (CNME), reports that the National Advisory Committee for Institutional Quality and Integrity (NACIQI) “voted unanimously to recommend that the US Department of Education (USDE) renew CNME’s recognition for 5 years-the longest time allowed; also, they determined that CNME is in full compliance with their regulations. The whole hearing process took about five minutes and CNMR stood out as the only accreditin agency among 8 being reviewed for renewed recognition that had no adverse findings.” Seitz anticipates that approval of the recommendation by the assistant secretary “will go smoothly.” He noted the important contributions of CNME president Rita Bettenburg, ND, and two leaders of the Association of Accredited Naturopathic Medical Colleges, Karen Howard and David Matteson.  

Comment: The latest renewal of recognition is newsworthy given the wild ride for the CNME with the US Department of Education since the agency was first recognized by hte USDE in 1987 when there were just 2 CNME-recognized on several occasions since. The first was for trumped up and ultimately bogus charges from mail-order NDs with what Seitz calls “online or abbreviated training” that don’t meet the CNME standards. In one other instance, internal issues with CNME resulted in a hiatus in the agency’s recognition. Happily for the NDs, and for quality, doctoral-level natural health education, the engine of opposition to the CNME, the former for-profit mail order business known as the Clayton College of Natural Health, shut its doors in 2010. (See HuffPo piece here and Integrator short here.) Twenty-three years later, there are now 7 CNME-recognized programs in North America. The latest review marks a new level of security for the naturopathic profession whose credibility is very much dependent on CNME’s status with the USDE. Now to insure there is work for all those educationally-mortgaged graduates!  

How Healthy is Your Bottled Water? (EWG)

View the best and worst brands of 2011

“Only three brands earned the highest possible … Gerber Pure Purified Water, Nestle Pure Life Purified Water, and Penta Ultra-Purified Water

[S]ix brands got the worst marks in EWG’s report … Whole Foods Italian Still Mineral Water, Vintage Natural Spring Water, Sahara Premium Drinking Water, O Water Sport Electrolyte Enhanced Purified Drinking Water, Market Basket Natural Spring Water, and Cumby’s Spring Water.  (Yahoo Green)