5 Turkey Day Tips

1. Use only free range or organic, hormone and antibiotic-free meat and poultry that are NOT self-basting.
   
   
2. Use real ingredients.
   
   
3. Reduce your overall caloric intake by substituting alcohol with sparkling water.
   
   
4. Exercise more leading up to and after Thanksgiving.
   
   
5. Don't force yourself to avoid desired foods during Thanksgiving (unless allergic/intolerant). You'll either be depressed or "pig out" later. Just eat a small portion and chew slowly to savor every morsel.
   

GOBBLE! GOBBLE!

Reporter's File: A Growing Array of Options for Fibroids

Excerpts taken from article By Leslie Berger, NY Times

Not so long ago, women typically had babies in their 20s, developed fibroids in their 30s and underwent hysterectomies in their 40s. For most, at least, that was the typical progression. But these days, as more women hold demanding jobs, many delay childbearing — and most expect more say in their health care. Hysterectomy is just one choice in a growing menu of treatments for uterine fibroids, one of the most common and least discussed of female afflictions. Several procedures, each new one less invasive than the last, have become available in the last decade, enabling women to avoid major surgery, protect their fertility and return to work within days rather than weeks.

With myomectomy, for example, doctors cut out the fibroids but leave the uterus intact. A technique called uterine artery embolization shrinks fibroids by blocking their blood supply. And with M.R.I.-guided ultrasound, tightly focused ultrasound beams zap fibroids, using magnetic resonance imaging to guide the process.

Moreover, new medicines are in development, including a class of drugs called progesterone receptor modulators that may shrink fibroids without inducing menopause and bone loss, as existing medications do. All the new treatments, as well as more sophisticated diagnostic techniques, are part of a growing interest in a condition long considered too unpleasant and embarrassing to talk about, even though nearly three-quarters of women are affected.

Fibroids, which are abnormal, multishaped growths of tissue and fat, appear in only one place in the body: the uterus. The tumors are almost always benign but can grow to the size of a football and cause menstrual bleeding and pelvic pain so severe that some women plan their schedules around their monthly periods. The excessive bleeding is not only disruptive but can also lead to anemia. Depending on their size and location, fibroids can also reduce fertility by as much as 70 percent and and cause several obstetric complications, including premature birth.

Bonnie - I have had clients do the embolization as well as ultrasound with much success and are much safer.

Probiotics 'may stop pneumonia'

Probiotics could be used to protect critically ill patients from developing pneumonia, according to scientists. The friendly bacteria can block the colonization by dangerous bugs of the airways of ventilated patients. The probiotic solution performed just as well as normal antiseptics used to keep pneumonia-causing bacteria at bay, the journal Critical Care reported. Being more natural it could pose fewer side effects. A probiotic that adheres to mouth lining will be able to work around the clock, unlike antiseptics which wear off after a few hours.

Cox-2 drugs less safe than Cox-1

The increased risk of heart attack that comes with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) to treat arthritis pain is directly related to the specific pain-causing molecule they act against. "We found a significant correlation between the degree of inhibition in vitro [in the laboratory] of whole blood cox-2, but not whole blood cox-1," said researchers in Spain and Italy. Cox-1 and cox-2 are different forms of cyclooxygenase, an enzyme whose activity increases inflammation and pain. Older NSAIDs, such as ibuprofen and naproxen, act primarily against cox-1. A newer generation of NSAIDs that act against cox-2 reduce the gastrointestinal bleeding, pain and inflammation that are major side effects of the cox-1 drugs, but they have been found to increase the risk of heart attack and stroke. Three cox-2 inhibitor NSAIDs have been marketed in the United States. Two of them -- Bextra and Vioxx -- were withdrawn from the market earlier this decade because of their association with an increased risk of heart attack and stroke. A third cox-2, Celebrex, remains available, but with a label warning of cardiovascular risk.

All NSAIDs increase heart risk, according to the new study of 8,852 people who had heart attacks. And the increase was related to both the dosage and the length of time the drugs were taken. But the risk was increased by 18 percent by drugs acting primarily against cox-1, compared to a 60 percent increase for those with the greatest cox-2 activity. The findings were published in the Nov. 11 issue of the Journal of the American College of Cardiology.

Bonnie - wow. I don't know how much more you need to see regarding these pain drugs. Get to the cause. Don't treat the symptoms.

Kids mimic parents' diets from an early age

Parents who want their preschoolers to eat their vegetables may need to take a hard look at their own eating habits. In a study of 120 young children who were allowed to "buy" food from a play grocery store, researchers found that even 2-year-olds tended to mirror their parents' usual food choices. Children who stocked up on sweets, sugary drinks and salty snacks generally had parents whose typical grocery list featured such items. Similarly, children with the healthiest shopping habits seemed to be following their parents' lead as well. The findings, reported in the Archives of Pediatrics & Adolescent Medicine, suggest that even very young children do not indiscriminately reach for candy when given the chance. Instead, they seem to already be forming food preferences -- potentially lasting ones -- based on their parents' shopping carts.

Bonnie - a real shocker, huh? Of course your kids are going to mirror your eating habits. This study is hilarious.

Vitamin E may slash lung cancer risk

Increasing intakes of vitamin E may decrease the risk of lung cancer by over 50 per cent, according to a new study from the US. Researchers from the University of Texas M.D. Anderson Cancer Center report that intakes of vitamin E in the alpha-tocopherol form were associated with consistent and independent reductions in lung cancer risk. The International Journal of Cancer details an ongoing study involving 1,088 patients with lung cancer (average age 61.7) and 1,414 healthy controls (average age 60.8). Dietary intakes were assessed using a modified version of the 135-item National Cancer Institute’s Health Habits and History Questionnaire Food Frequency Questionnaire. Demographic and lifestyle data were also collected, including smoking habits. The researchers calculated that the highest average intakes of alpha-tocopherol (more than 7.73 mg per day) were associated with a 53 per cent reduction in lung cancer risk, compared to the lowest average intakes (less than 4.13 mg per day). This result took into account the other forms of tocopherols. When the researchers accounted for the other tocopherols they observed no significant associations on lung cancer risk for beta-, gamma, and delta-tocopherol. Considering all the tocopherols together, the highest average intake (more than 12.95 mg per day) was associated with a 55 per cent reduction in the risk of lung cancer, compared to the lowest average intakes (less than 6.68 mg per day), said the researchers.

Bonnie - as opposed to the Prostate study that came out last week, here is a perfect example of a study that investigated natural forms of vitamin E instead of synthetic. The study also took into account all vitamin E tocopherols and tocotrienols, instead of only one of the eight, which is what the prostate study looked into. Of course, this study will get no media exposure.

Children increasingly medicated

More and more U.S. children are being given drugs to fight chronic conditions such as asthma and hyperactivity. From 2002 to 2005 prescriptions for medicines to treat type-2 diabetes doubled, asthma medications rose by more than 46 percent, medicines for attention-deficit hyperactivity disorder increased by more than 40 percent and prescriptions for cholesterol-lowering drugs were up by 15 percent. The report published in the November issue of Pediatrics said the increases could mean that chronic conditions are on the rise. The findings were based on insurance claims for 3.2 million children aged 5 to 19.

Bonnie - unfortunately, we have been watched this trend go the wrong way. Until parents make fundamental changes in what groceries they shop for and end the consistent caving in to their kid's dietary demands, these numbers will continue to rise. The only thing food manufacturers understand is the dollar. They go where the money goes. Parents need to make a monetary statement to choose healthier fare. The government can also play an influential role in guiding parents. While they have made baby steps, until the farm bill is fundamentally alters what are considered cash crops, we are only looking at cosmetic change. Educating the public about a balanced diet can only come when corn, wheat, milk, soy, and sugar take a lesser role in the Standard American Diet (SAD).

USDA Publishes Proposed Amendment for Organic Livestock Farmers

The United States Department of Agriculture (USDA) has published a proposed amendment to the federal organic regulations that sets new grazing requirements for organic livestock and bans confined feedlots from the industry.

The USDA’s proposed rule clarifies requirements for organic livestock producers, principally dairy farmers, requiring their animals to graze on pasture and consume a significant percentage of their feed intake during the growing season. The rule also proposes expanding the definition of livestock to include bees and aquatic animals.

According to the Organic Trade Association (OTA), this regulation will continue to reinforce for shoppers that organic dairy products and beef, for example, are from animals that are receiving proper feed, access to fresh air and sunshine, and well-managed living conditions.

"Organic production is about continuous improvement of farms and the environment, and this proposed regulation is the next step in improvements for organic dairy, beef, lamb and goat production in the United States,” said Christine Bushway, OTA's executive director.

The Cornucopia Institute, however, has brought to light some concerns about the new proposal from past chair and member of the National Organic Standards Board (NOSB), Jim Riddle.

“While I appreciate the fact that the USDA has issued proposed rules to clarify pasture requirements, based on NOSB recommendations, I am very concerned about the proposed language on dairy replacement animals,” said Riddle.

Added Riddle, “The proposed change, contrary to language recommended by the NOSB, would institutionalize the current two-track system, which allows certain operations to continually bring in conventional heifers, while other operations are required to use only replacement heifers that have been raised organically from the last third of gestation. There should be one standard for all organic dairy farms, once they have converted to organic production.”

USDA is accepting public comments on the proposed regulations until December 23.

FDA Amendment to Include Vitamin D in Osteoporosis Claims

Effective January 1, 2010, the Food and Drug Administration (FDA) amended its label regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D.

Manufacturers will be able, under these new rules, to recreate product labels to add health claims to their products that qualify or reformulate products (by fortifying with calcium or vitamin D) to qualify for the health claims.

The FDA solicited comments on the calcium and vitamin D proposed rule, with the comment period closing on March 21, 2007.

Take Nexium to reduce aspirin-related ulcers!

Regular low-dose aspirin, taken typically to ward off a heart attack, may increase the risk of developing stomach ulcers, but this can be counteracted by taking another pill -- esomeprazole, more familiarly known as Nexium.

That finding comes from a study reported in the American Journal of Gastroenterology. Esomeprazole is a proton pump inhibitor, meaning that it suppresses gastric acid.

Bonnie - what an ideal scenario (snicker, snicker)! Mask the symptoms of aspirin with another drug that suppresses stomach acid. Of course, it was never mentioned in the study that stopping the aspirin may be a better alternative. In addition, all proton pump inhibitors destroy B-12 over time and make individuals more prone to opportunistic pathogens such as H. Pylori, a known cause of ulcers.

Epigenetics, Development, and the Kidney

"How cells partition the genome into active and inactive genes and how that information is established and propagated during embryonic development are fundamental to maintaining the normal differentiated state. The molecular mechanisms of epigenetic action and cellular memory are increasingly amenable to study primarily as a result of the rapid progress in the area of chromatin biology. Methylation of DNA and modification of histones are critical epigenetic marks that establish active and silent chromatin domains. During development of the kidney, DNA-binding factors such as Pax2/8, which are essential for the intermediate mesoderm and the renal epithelial lineage, could provide the locus and tissue specificity for histone methylation and chromatin remodeling and thus establish a kidney-specific fate. The role of epigenetic modifications in development and disease is under intense investigation and has already affected our view of cancer and aging." J Am Soc Nephrol 19: 2060-2067, 2008

Steve - translation: the bridge between our lifestyle and genes is epigenetic. Negative expression of our genes can be controlled epigenetically if we make proper lifestyle choices. This begins prenatally, throughout pregnancy, into early childhood, and beyond. Lifestyle choices do not just affect you, but the next generation after you, and several after that. While it seems almost too much of a burden to bear, the research is making the picture clearer nevertheless.

Kidney Stones Cases Rise in U.S. Children

To the great surprise of parents, kidney stones, once considered a disorder of middle age, are now showing up in children as young as 5 or 6. While there are no reliable data on the number of cases, pediatric urologists and nephrologists across the country say they are seeing a steep rise in young patients. Some hospitals have opened pediatric kidney stone clinics.

The increase in the United States is attributed to a host of factors, Poor diet is the leading cause of kidney stones, which are crystallizations of several substances in the urine. Stones form when these substances become too concentrated. Forty to 65 percent of kidney stones are formed when oxalate, a byproduct of certain foods, binds to calcium in the urine. (Other common types include calcium phosphate stones and uric acid stones.) And the two biggest risk factors for this binding process are not drinking enough fluids and eating too much salt; both increase the amount of calcium and oxalate in the urine. Excess salt has to be excreted through the kidneys, but salt binds to calcium on its way out, creating a greater concentration of calcium in the urine and the kidneys.

Experts mentioned not just salty chips and French fries, but also processed foods like sandwich meats; canned soups; packaged meals; and even sports drinks like Gatorade, which are so popular among schoolchildren they are now sold in child-friendly juice boxes. Children also tend not to drink enough water.

A common misconception is that people with kidney stones should avoid calcium.

Bonnie - low levels of B-6 and magnesium prevent kidney stones. Highly processed foods contain very little, if any, of these key nutrients.

Prostate Cancer Prevention Study Shows No Benefit for Use of Selenium and Vitamin E

Initial, independent review of study data from 35,000 men 50 and older from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute (NCI), shows that selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer over a five year period.

Bonnie - I cannot acknowledge any result from this study because it was flawed from the beginning:

1. 200 mcg. selenium is a very small dose when gauging therapeutic value. Regardless, it is intended to be a complementary trace mineral for prostate health because it cannot be taken in large amounts due to toxicity issues.
   
   
2. The vitamin E used in the trial was 400IU dl-alpha tocopherol, which is a synthetic form of vitamin E. Anyone knowledgeable health professional understands that synthetic E is worthless. In addition, most positive vitamin E research has predominately used mixed tocopherols, which compromises alpha, beta, gamma, and delta tocopherols; not just alpha alone. It has long been known that all four tocopherols need to work in unison for optimum effectiveness.

Will we see or hear about these two humongous flaws in the study? Probably not.

Facts About Today's Food Supply

Consuming a balanced diet that meets the recommended servings of fruits, vegetables, whole grains, essential fatty acids and lean sources of protein still may not ensure ample nutrient intake due to changes in our food supply.

Changes in the average nutrient content of 43 fruits and vegetables between 1950 and 1999 resulted in the following:

• 6% decrease in protein
• 16% decrease in calcium
• 9% decrease in phosphorus
• 15% decrease in iron
• 38% decrease in riboflavin
• 20% decrease in ascorbic acid

Food quality changes like these are the result of multiple factors:

Storage time and maturity at harvest
Nutrients can be harmed during storage or transportation. Storing tomatoes for 5 days decrease ascorbic acid by almost 13%. Harvesting plants prior to proper maturity diminishes nutrient content potential, particularly for fiber, vitamin A, vitamin C and polyphenols.

Genetic selection
Modern fruits and vegetables are genetically selected, and in some cases modified, for shelf life, high yield or other growth characteristics rather than their ability to extract or synthesize nutrients from the environment.

Atmospheric CO2
An increased level of CO2 in the atmosphere, due to pollution, decreases the nitrogen, potassium, magnesium and protein content of plants.

Fertilization quality
Fertilization of the soil with isolated key nutrients such as nitrogen, phosphorus and potassium, as opposed to more comprehensive fertilizers, can alter the composition of plants and lead to nutrient losses. For example, plants raised on high-potassium soil have higher levels of potassium, but reduced levels of calcium and magnesium.

Growing region
Differences in climate and soil type can cause large variations in nutrient content. Calcium-rich soil will produce plants higher in protein, while potassium-rich soils produce plants higher in carbohydrates. Regional rainfall can create wide variations in vegetable mineral composition, particularly for calcium, magnesium and potassium.

Farming practices
Free-range animals produce meat with significantly higher levels of omega-3 fatty acids and conjugated linoleic acid. Dairy products made from grass-fed animals are also higher in vitamin A, E and beta-carotene. Unfortunately, most farm animals are restricted to feedlots and given regular hormone or antibiotic treatments, resulting in meat containing lower levels of these critical nutrients.

Industrial waste and contamination
Chemical residues and industrial waste, including heavy metals, pollute the land, water and food supply. Most of us carry a significant body burden of pesticides and pesticide metabolites.

Conclusion
Unlike foods, supplements also have the benefit of providing consistent levels of vitamins and minerals. Beyond the food supply, there are myriad reasons for taking supplements which we have discussed incessantly: stress, nutrient-depleting meds, genetic variables, environment, chronic or acute disease, etc.

Going Loco for Local.

Locally grown food tastes better.
Food grown in your own community is usually picked within the past day or two. It’s crisp, sweet, and loaded with flavor. Produce flown or trucked is much older. Several studies have shown that the average distance food travels from farm to plate is 1,500 miles.

Local produce is better for you.
Fresh produce loses nutrients quickly. Locally grown food, purchased soon after harvest, retains its nutrients.

Local food preserves genetic diversity.
In the modern industrial agricultural system, varieties are chosen for their ability to ripen simultaneously and withstand harvesting equipment. Only a handful of varieties of fruits and vegetables meet those rigorous demands, so there is little genetic diversity in the plants grown. Local farms, in contrast, grow a huge number of varieties to provide a long season of harvest, an array of eye-catching colors, and the best flavors.

Local food is GMO-free.
Although biotechnology companies have been trying to commercialize genetically modified fruits and vegetables, they are currently licensing them only to large factory-style farms. Local farmers don’t have access to genetically modified seed, and most of them wouldn’t use it even if they could.

Local food supports local farm families.
With fewer than 1 million Americans now listing farming as their primary occupation, farmers are a vanishing breed. Local farmers who sell direct to consumers cut out the middle man and get full retail price for their crops.

Local food builds a stronger community.
When you buy direct from the farmer, you are re-establishing a time-honored connection between the eater and the grower.

Local food preserves open space.
As the value of direct-marketed fruits and vegetables increases, selling farmland for development becomes less likely. The rural landscape will survive only as long as farms are financially viable.

Local food helps to keep your taxes in check.
Farms contribute more in taxes than they require in services, whereas suburban development costs more than it generates in taxes.

Local food supports a clean environment and benefits wildlife.
A well-managed family farm is a place where the resources of fertile soil and clean water are valued. Good stewards of the land grow cover crops to prevent erosion and replace nutrients used by their crops. Cover crops also capture carbon emissions and help combat global warming.

Local food is about the future.
By supporting local farmers today, you can help ensure that there will be farms in your community tomorrow, so that future generations will have access to nourishing, flavorful, and abundant food.

5 Most Dangerous Food Additives.

If you see the following ingredients in your pantry or at the grocery store, throw out and avoid.

1. Artificial Sweeteners - Aspartame harms nerve cells because when broken down in the body, it turns into formic acid and formaldehyde; sucralose, saccharin, acesulfame-K, neotame, and others are no better.
   
   
2. Trans Fats - hydrogenated oils, shortening; added to baked goods and processed foods to increase shelf life; some labels say "zero trans fats" but legally may still contain 0.5 grams; creates a host of inflammatory-related diseases.
   
   
3. Monosodium Glutamate (MSG) - flavor enhancer added to foods to enhance salty taste; causes neurologic, cardiac, and digestive issues; found in countless foods, including soups, ethnic foods, salad dressings, and many vegetarian items. Beware of hidden MSG under the names yeast extract, hydrolyzed vegetable protein (anything hydrolyzed), plant protein extract, sodium caseinate, calcium caseinate, textured vegetable protein, autolyzed yeast, torula yeast, malt extract; MSG also appears as natural flavorings and spices in some cases (you must trust the brand to be MSG-free).
   
   
4. Nitrates/Nitrites - chemicals added to processed meats to make salty and appear red in color; carcinogenic and allergenic.
   
   
5. Artificial Food Colors & Flavors - you may see the word F.D.&C. Yellow, red Dye 40, blue 1, etc.; linked to cancer, allergy, nausea; just one color additive can cause behavioral disorders in children; banned in Europe, but availble in foods, medications, and cosmetics in US.
   

Honorable Mention -

1. High Fructose Corn Syrup - processed sweetener that is much cheaper than sugar; indicated in obesity and diabetes; worse than any other conventional sweetener, despite what The Corn Refiners Association's PR campaign leads you to believe.
   
   
2. Acrylamide - chemical produced during high temperature cooking in foods such as french fries, cakes, and snack foods; considered "probable" in relation to several forms of estrogen-receptor positive cancers; chip companies Heinz, Frito-Lay, Lance, Proctor and Gamble, and Kettle Foods recently settled a lawsuit in California agreeing to lower levels of acrylamide in their foods; European Safety Authority has agressively reduced acrylamide levels in their food products.
   

FYI -

• Many Florida oranges are dipped in artificial orange dye to make them more visually appealing.

• There are many foods which are marketed as "healthy" or vegetarian/vegan foods that contain many of the aforementioned offending ingredients. Our Natural Foods Shopping List helps you avoid this, because we've screened the brands for you already.

• Ahi Tuna, Sashimi Tuna, and Farmed Salmon are treated with artificial dye for color.

Osteoporosis drugs and irregular heartbeat

People who take bisphosphonates, drugs for prevention or treatment of osteoporosis may be at increased risk for atrial fibrillation, or irregular heartbeats, according to research presented today at a conference of the American College of Chest Physicians.

Atrial fibrillation can produce a variety of symptoms, including light-headedness, palpitations, chest pain, shortness of breath -- or no symptoms at all. The study involved more than 16,000 women ages 69 to 75, some of whom took bisphosphonates and some of whom took a placebo. Of those who took the real drugs, 2.5% to 3% experienced irregular heartbeats. For 1% to 2% of the women who took bisphosphonates, the episode was serious, resulting in hospitalization or death, according to the study. Overall, the women taking bisphosphonates were twice as likely to suffer a serious heartbeat irregularity.

It's not the first time the association has been made between the drugs and an irregular heartbeat. A study in the May 3, 2007, New England Journal of Medicine found that while the drugs reduced the risk of fractures, the researchers noted an increased incidence of atrial fibrillation in women getting a once-yearly infusion of bisphosphonates.

Bonnie - how many more studies are we going to have to read about until these class of drugs go away?

McDonald's tests steamer cooking

McDonald’s Corp. is in the early stages of testing a steamer that could cook shrimp, broccoli and oatmeal, indicating that such possible products “speak to a healthier and more expansive product focus going forward” for the world’s largest fast-food chain. Health-conscious menu offerings such as salads and snack wraps have played a critical role in the recent turnaround of Oak Brook-based McDonald’s. The steamer could also cook scrambled eggs in 10 seconds. McDonald’s also told analysts during a meeting Thursday about an energy-efficient fryer that uses 20% less energy and 40% less oil.

Steve - I'll believe when I see it. The wraps and salads (especially with dressings) are nothing to write home about. However, when McDonald's makes "improvements" to their menus, the competition often follows suit.

Large food companies add new nutritional label

Several of the largest U.S. food and beverage makers have agreed to implement a new nutritional labeling system on their packages aimed at helping consumers pick healthier food choices. The new Smart Choices symbol was developed by the companies, scientists, health organizations and others over the past two years that wanted to come up with one standard to identify healthier foods. The Smart Choices symbol will be placed on the front of packages of foods that meet certain criteria and will contain two simple pieces of information: calories per serving and the number of servings in a package. To qualify for the Smart Choices symbol, foods would need to meet certain benchmarks in limiting items like total fat, trans fat, sodium and added sugars, while also containing beneficial items like fiber, calcium and certain vitamins. Among companies that will use the symbol are Coca-Cola Co, General Mills Inc, Kellogg Co, ConAgra Foods Inc, Kraft Foods Inc, PepsiCo Inc and Unilever, as well as retailer Wal-Mart Stores Inc. The Smart Choices label will begin appearing on packages in the middle of 2009.

Steve - huh? Nutritional labeling system created by the companies that make the products? Isn't that convenient. I cannot wait to see what is considered a "Smart Choice."

Reports of serious drug reactions hit record

The number of serious problems and deaths linked to medications reported to the government set a record in the first three months of this year, a health industry watchdog group said Wednesday. The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, said an analysis of federal data by the nonprofit Institute for Safe Medication Practices, which scrutinized data going back to 2004, and yearly totals dating to the 1990s. Two drugs accounted for a disproportionately large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer. Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient tries to light up again. But earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The government banned it for pilots. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the drug's side effects. The FDA had no immediate response to the report. The watchdog group, known as ISMP, has served hospitals and pharmacists for years as a clearinghouse for information on drug safety and medication errors. It is now reaching out to consumers with regular reports on drug safety trends, drawn from FDA records. "We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with the group. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety." The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems. The total of 20,745 cases reported from Jan.-March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said. Fatalities accounted for 23 percent of the cases. The total number of deaths, 4,824, was an increase of nearly 3 percent from the last calendar quarter of 2007. Previous research from ISMP has shown that serious drug safety problems reported to the FDA increased markedly from 1998-2005. The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate "probable cause," but not neccesarily "guilt beyond a reasonable doubt." The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period has reported 238 deaths possibly linked to heparin. Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said. Not so with Chantix, it concluded. The FDA should forcefully warn patients taking Chantix that they may have blackouts and other problems that could lead to accidents, the report said. The current warnings say that patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA received 1,001 reports of serious injuries possibly linked to Chantix, more than for the ten best-selling brand name drugs combined. Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but nonetheless concluded that there are enough to warrant further action by the FDA. Pfizer said the total sum of its data on Chantix, including results from clinical trials, show that the drug's benefits clearly outweigh its risks. "We stand by the efficacy and safety profile of Chantix," the company said in a statement. "There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globablly. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting."