This figure comes from the U.S. Centers for Disease Control and Prevention (CDC). To arrive at this total, a CDC study reviewed 2004-2005 data provided through the National Electronic Injury Surveillance System. The information came from a cooperative adverse drug event surveillance project done to describe emergency department visits due specifically to cough and cold medications. The results were published online in the American Academy of Pediatrics journal, Pediatrics.

The study noted that approximately two-thirds of the incidents requiring emergency room treatment were due to “unsupervised ingestion.” This would fall into the category of children taking the medication without a parent’s knowledge or supervision. Children between the ages of 2 to 5 accounted for 64 percent of the adverse drug events from

cough and cold medications. More than 80 percent of these cases involved an “unsuper­vised ingestion.” Among all age groups, 93 percent of the children did not require a hos­pital admission, but one-fourth did need additional treatment to eliminate the medicine from their bodies.

“Parents need to be vigilant about keeping these medicines out of their children’s reach,” said Dr. Denise Cardo, director of the Division of Healthcare Quality Promotion for CDC. “They should refrain from encouraging children to take medicine by telling the children that medication is candy.” Dr. Cardo also suggested that adults should avoid tak­ing adult medications in the presence of their young children as this may encourage a child to do the same without the proper supervision.

On January 17, 2008, the U.S. Food and Drug Administration (FDA) issued an advi­sory recommending that over the counter cough and cold medications not be used for children. Several months earlier an advisory committee of the FDA had reached the same conclusion. In anticipation of these actions, major manufactures of cough and cold med­ications had begun voluntarily withdrawing these medications from the market in November.

Currently, the FDA is continuing an investigation into the safety of cough and cold medications for children ages 2 to 11. In the meantime, the FDA warns that parents should definitely not give cold and cough medications to younger children that were intended for older children. One final advisory to parents is that they should dispose of any previously purchased products that were intended for children age 2 and younger.

Source: The U.S. Centers for Disease Control and Prevention. Press Release. January 2008. http://www.cdc.goviod/oc/media/pressrel/2008/t080128.htm

An FDA investigation into hearing loss followed on the heels of a report in the April issue of the Journal of Laryngology & Otology of a man experiencing the problem after taking Viagra^®. The search into the FDA Adverse Events Reporting System turned up 29 cases that involved erectile dysfunction drugs or the drug Revatio^® which is used for control of severe hypertension. In most cases, the hearing loss was accompanied by ringing in the ears, vertigo or dizziness. Usually, the hearing loss involved one ear and resulted in either a partial or complete loss of usual hearing. In approximately one third of the cases the event was tempo­rary, but in the remainder, the hearing loss was ongoing.

Cialis^®, Levitra^® and Viagra^® are the most common types of heavily advertised drugs aimed at helping men with erectile issues. The drug Revatio^® is used to treat pulmonary arte­rial hypertension, a serious medical condition in which continuous high blood pressure in the arteries of the lungs weakens the heart muscle and often leads to heart failure and death, according to the FDA report.

“Because some level of hearing loss is usually associated with the aging process, patients taking these drugs may not think to talk to their doctor about it,” said Dr. Janet Woodcock, M.D., the FDA’s deputy commissioner for scientific and medical programs and acting direc­tor of its Center for Drug Evaluation and Research. The FDA instructions to Cialis, Levitra and Viagra users is to discontinue the drug and immediately seek medical attention if hearing problems develop. Revatio users are instructed to continue taking their medication, but they should contact their healthcare provider for further evaluation. Because Revatio is taken to treat a potentially life-threatening situation, the FDA does not recommend abruptly stopping usage if hearing loss occurs.

The strong relationship demonstrated between the use of these drugs and sudden hearing loss warrants revisions in product labeling, according to the FDA. In the future, Cialis, Levitra, Viagra and Revatio products will bear warnings regarding sudden hearing loss and the course of action to take if such an event happens.

Source: The U.S. Food and Drug Administration, FDA News, October 2007. http://wwwfda.govibbs/topics/NEWS/2007/NEW01730.html

“There is no scientific evidence that anesthetics commonly administered for decades cause brain damage in children”, the report said. No studies have been done to determine the effects of anesthetics on developing human brains, but numerous animal studies show that most such drugs used on children kill brain cells in young rats, mice and rhesus monkeys that can lead to subtle but pro­longed changes in behavior, including memory and learning impairments.

The report raises new concerns about putting infants and children under anesthetics for surgery. It calls for the medical community to work together to develop strategies for further assessing the safety of pediatric anesthetics, and for new guidelines for doctors who must choose anesthetic regimens for their pediatric patients.

The animal studies suggest young animals are most susceptible to the drugs during the period of rapid growth of the brain. In humans, that period begins before birth, in the third trimester, and extends to about age 3. An estimated 600,000 children within that age range receive general anesthesia each year.

Many of the operations performed on children are to save their lives or improve their quality of life. Skipping or even delaying such surgeries would have its own risks, according to FDA officials.

“We’re certainly not looking at saying anesthesia should not be used on children,” FDA officals told The Associated Press, adding that it’s generally considered one of medicine’s greatest advances.”

SOURCE: Food and Drug Administration, March 2007; http://www.anesthesia-analgesia.org/cgi/content/abstract/104/3/509

Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group, a national, nonprofit consumer advocacy organization based in Washington, D.C., said the drug clearly causes pre-can­cerous lesions of the colon (aberrant crypt foci or ACF) and its approval for over-the-counter availability is, “the height of recklessness and shows a profound lack of concern for the public’s health.”

The connection of ACF with carcinogenesis is so well-recognized that the appearance of ACF in rats is used by many groups to test the potential carcinogenicity of chemicals, Wolfe said. For example, the Environmental Protection Agency (EPA) uses an ACF assay in its tests of possible carcinogens.

In April 2006, after opposing the OTC switch, Public Citizen petitioned the FDA to ban the pre­scription version of orlistat – Xenical – because of the two studies documenting its ability to cause ACF. There are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.

In opposing the over-the-counter approval a year ago, the Public Citizen said, that “the switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent co-existence of other diseases, common, bothersome (gastrointestinal) adverse reactions, significant inhibition of absorption of fat soluble vitamins (A, D, K and E), and problematic use in the millions of people using the blood thinner warfarin (Coumadin^®) because of orlistat-induced Vitamin K deficiency.”

OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli ^Tm and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program, the FDA said.

“We strongly urge people not to use this potentially dangerous drug,” Wolfe said, “and we pre­dict that, like the rapidly declining sales of the prescription version, the over-the-counter version will turn out to be a loser after enough people have a bad experience with it.

SOURCES: http://www.fda.govibbs/topics/NEWS/2007/NEW01557.html http://www.citizen.org/hot_issues/issue.cfmM=1539

The FDA has received reports that the drug is responsible for causing behavior/mood changes, suicidality (suicide thinking and behavior) and suicide. The agency has issued a warning to healthcare professionals and users of the drug that it is conducting an investigation even though it is not telling people to immediately stop using the medication.

Singulair is a drug that is used to treat asthma and the symptoms of rhinitis including runny nose, itching of the nose, sneezing and stuffy nose. It is also pre­scribed to prevent asthma that is induced by exercise.

Reports to the drug maker have already caused Merck to take action to update pre­scribing information to doctors and usage information to patients. These updates fall under the area of “post-marketing adverse effects.”

Here are the adversely reported effects for which Merck already executed a series of informational updates in the past year for the prescribing of Singular:

• Tremor, March 2007.
• Depression, April 2007.
• Suicidality, October 2007.
• Anxiousness, February 2008.

The FDA has indicated that it may take up to 9 months to determine the results of this investigation. Regardless of the FDA’s position on Singulair, it is warning both to doctors and to users to be alert to the risk of altered behavior and suicidal thinking.

Singular falls into a category of drugs known as “leukotriene receptor antagonists.” (Leukotriene is a compound that works to regulate allergic and inflammatory reac­tions.) Additional leukotriene modifying medications include the drugs Accolate^®, Zyflo^® and Zyflo CR^®.

According to the FDA, “Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.”

Source: The U.S. Food and Drug Administration. “Early Communication about an Ongoing Safety Review of Singulair.” April 2008. http://www.fda.gov/cder/drug/early_comm/montelukast.htm and http://www.fda.gov/medwAtch/safety/2008/safety08.htmitSingulair

This new drug called Lyrica^® (pregabalin), marketed by Pfizer, claims to reduce pain and improve function in patients with fibromyalgia. Some of the side effects include dizziness, sleepiness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions can also occur. These are rare, but are potentially serious. The FDA advises patients to talk with their doctors about whether using Lyrica will impair their ability to drive.

Fibromyalgia affects 3 million to 6 million people in the United States each year. People with fibromyalgia can experience pain anywhere, but common sites of pain include the neck, shoulders, back, hips, arms, and legs. In addition to pain and fatigue, other symptoms include: difficulty sleeping, morning stiffness, headaches, painful menstrual periods, tin­gling or numbness of hands or feet, and difficulty thinking and remembering. Some people with the condition may also experience irritable bowel syndrome, pelvic pain, restless leg syndrome, and depression.

Although the causes of fibromyalgia remain “unknown” by general medicine, the field of Oriental Medicine believes this condition is due to liver stagnation and toxicity. When the kidneys and liver get overwhelmed by toxins, from foods and the environment, it causes pain and fatigue. Today’s medical options for relief of this condition are pain killers, sleep­ing drugs and muscle relaxants, and psychiatric medications that merely cover up the con­dition. These drugs merely do more damage to the liver and kidneys.

The safest solution for this painful condition is a natural approach such as Acupuncture or Chiropractic. These natural healthcare professionals are trained to find the source of the disease for a natural and more permanent solution for the relief of pain and fatigue.

Source:U.S. Food & Drug Administration, June 2007, http://wwwida.goviconsumer/updatesifibromyalgia062107.html and Acupuncture Today, “Fibromyalgia”. Lyrica^® is a Registered trademark of Pfizer, Inc.

The ongoing campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries from the FDA’s Center for Food Safety and Applied Nutrition. The letters sent to marketers and makers of products for which cures are claimed are warned they have 15 days to remove all such claims. Failure to do so can lead to seizures of product, prosecu­tions and fines. The letter offers no advice, help or encouragement for testing the product.

“We will continue working with our partners in the U.S. and internationally to make sure scammers have no place to hide,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection.

FTC has also launched a campaign to teach consumers how to avoid phony diabetes cures. The materials encourage consumers to “Be smart, be skeptical!” and will be available in English, Spanish, and French. One component is a “teaser” Web site available at http://wemarket4u.net/glucobate/index.html. At first glance, the site appears to be advertising a cure for diabetes called Glucobate, but when consumers click for more information on ordering the prod­uct, it reveals information about avoiding ads for phony cure-alls in the future.

The FDA/FTC uses the terms “scammers”, “deceptive advertisements”, “misrepresented as cures” and “fraudulent cures and treatments” to describe any claims to alleviate any physical or mental condi­tions or illnesses for substances or procedures of any kind that have not been through the approvals process of the FDA.

Claims that a substance can cure anything automatically classifies that substance as a drug, accord­ing to the Federal Food, Drug, and Cosmetic Act, and drugs must be approved by the FDA. Unfortunately, there are very few FDA-approved drugs that claim cures, since cures are not popular with the big pharmaceutical companies that can afford the elaborate scientific testing needed for approvals.

It’s good that we have a government working to protect us from potential dangers. But in a more perfect world, the government would also have well-financed systems in place that would help facili­tate testing all reasonable avenues and ideas for cures for disease.

Instead, our government’s health agencies appear to be in league with rich and powerful pharma­ceutical companies whose stock in trade is maintaining disease, not producing cures and health. There’s no future profit in healthy people.

SOURCE: http://www.fda.govibbs/topics/NEWS/2006/NEW01494.html

The comprehensive study examined reviews from the U.S. Food and Drug Administration (FDA) for trials of 12 widely prescribed antidepressant drugs approved between 1981 and 2004. A total of 12,564 patients were involved. In addition, researchers also conducted a sys­tematic literature search to identify whether results of studies had been published in any other medical journals. For those that were published, the researchers continued on to determine if the published versions of the results matched the FDA’s version of the results.

Basically, what researchers found was that the publishing of results and how the results were reported depended entirely on the outcome of each trial. This information comes from Erick Turner, M.D., who is an assistant professor of psychiatry, physiology and pharmacolo­gy at Oregon Health & Science University and the Medical Director of the Portland Veterans Affairs Medical Center’s Mood Disorders Program.

Dr. Turner and his group found that according to the published literature, nearly all of the studies conducted (94%) had positive treatment results. This figure varies considerably from data provided to the FDA which showed, in fact, that only about half of the studies (51%) had positive results.

Unsurprisingly, drug companies were found to be very selective in the studies they did publish and were found to engage in deceptive and inaccurate reporting as well. Positive studies, with one exception, were all published. Additionally, 33 of 36 studies that were not positive were either not published or published deceptively as if they were positive, the researchers found. These 33 studies involved 5,212 patients.

“Selective publication can lead doctors and patients to believe drugs are more effective than they really are, which can influence prescribing decisions,” said Dr. Turner. While the doctor did mention that a failure of a study author or sponsor to submit a non-positive manu­script or an editor’s decision not to publish it could have some affect on the process, there was very clear bias in the reporting of some findings and failure to report others. “Doctors and patients must have access to evidence that is complete and unbiased when they are weighing the risks and the benefits of treatment,” he said.

Source: ScienceDaily, Press Release, January, 2008. http://www.sciencedaily.com/releases/2008/01/080116202037.htm

Fibromyalgia is a disorder that is characterized by chronic aches and tenderness in the muscles, fatigue and sleep problems. Pain usually occurs in the neck, shoulders, back, hands and pelvis. While there is no permanent damage to the joints or muscles associated with it, the pain it brings can be quite intense and difficult to live with. It is estimated that between 3 to 6 million people in the United States suffer from it each year. Statistics show that more women than men are affected, typically starting in early-to-middle adulthood.

It is interesting to note from the FDA commentary on Lyrica that while some test patients experi­enced a lessening of pain, not all experienced relief from the product. According to Steven Galson, M.D., the director of FDA’s Center for Drug Evaluation and Research, “Consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder.”

Also interesting is that it was approved even though the maker of the drug, Pfizer Inc., and the FDA were not able to provide detailed information of just how it works. According to the FDA, “Individuals with Fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which Lyrica produces such an effect is unknown.”

Finally, the FDA included the following warning to people using Lyrica: “The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and atten­tion. FDA advises that patients talk to their doctor or other healthcare professional about whether use of Lyrica may impair their ability to drive.”

Also interesting is that the FDA made no mention of possible alternative methods for treating Fibromyalgia symptoms. These would include a healthy diet, adequate rest, exercise, stretching of affect­ed areas, physical therapy, Chiropractic adjustments or Acupuncture treatments. It’s also noteworthy that this drug was originally targeted toward handling nerve pain associated with diabetes. When its approval was declined, it was retargeted toward Fibromyalgia pain and thus received FDA approval.

Persons suffering from the symptoms of Fibromyalgia should be thoroughly examined by a chiro­practor and/or an acupuncturist given healthy treatment options. This should be done long before consid­ering a drug that showed marginal test results and requires a slew of FDA warnings to consumers.

Source: The U.S. Food and Drug Administration, June 2007. http://www.fda.govibbs/topics/NEWS/2007/NEW01656.html and http://www.fda.goviconsumer/updates/fibromyalgia062107.html

In some children, unintentional overdoses have caused heart rhythm changes, cardiopulmonary arrest, hallucinations, psychoses, hypertension and seizures, according to research cited in the petition.

“Over-the-counter cough and cold preparations are neither safe nor effective for use in young children,” the petitioners argue. “The FDA has never conducted an appropriate analysis to support their widespread use, and expert organizations agree that they are ineffective and pose a risk to health.”

The petitioners urged the FDA to tell drugmakers the continued marketing of such products for infants and young children is not supported by scientific evidence and should lead to enforcement actions against the makers.

Dr. Joshua Sharfstein, Baltimore’s commissioner of health, led the group of 15 petitioners who include such pediatric luminaries as Dr. Janet Serwint, professor of pediatrics at the Johns Hopkins University; Dr. Steven J. Czinn, chairman of pediatrics at the University of Maryland School of Medicine; and Dr. Michael Shannon, professor of pediatrics at Harvard Medical School.

“These are very senior pediatricians,” Sharfstein said. “That kind of expertise is not something the FDA gets petitions from every day.

“I think this is something that should be wrapped up fairly quickly because the evidence on this is clear. They don’t work, and they’re not safe,” he said.

FDA Says No Need for Immediate Action

FDA officials have replied that the agency plans to review the matter over the next several months. One official told reporters at a Washington briefing that there is no need for immediate action.

Dr. Charles Ganley, director of the Office of Nonprescription Products said the review will include an assessment of the safety and efficacy of cold and cough medications for children, as well as how dosage levels for them are drawn up. In the meantime, he said, parents should be careful to follow directions on the products.

“If we thought there was a need to come out with an immediate statement, we would do so,” Ganley said. “Parents need to adhere to those dosing directions. If the directions are to consult a physician, parents need to adhere to that.”

SOURCE: http://www.baltimoresun.com/news/health/bal-te.fda03mar03,0,5046187.story?coll=bal-nationworld-headlines

The letters from Congress were sent to Amgen, which markets Aranesp® and Epogen®, and to Johnson & Johnson, which makes Procrit®, requesting them to stop advertising their potentially life-threatening products until the FDA further assesses the safety of the drugs.

Called “erythropoiesis stimulating agents (ESAs)”, the drugs were approved by the FDA to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Anemia is a blood disorder caused by a shortage of healthy red blood cells. Erythropoiesis is the process by which red blood cells (erythrocytes) are produced; in adults, most red blood cells are produced in the bone marrow.

FDA Orders “Black Box” Label Warnings

Earlier in the month, the FDA announced “black box” warning labels for the drugs, citing an increased risk of blood clots, heart attacks and even death in kidney patients when the drugs are taken at higher than recommended doses. When used in cancer patients with anemia not caused by chemotherapy — a use not approved by FDA — studies showed increased risk of death even when the drugs were prescribed at normal levels.

Johnson & Johnson said that it stopped marketing Procrit directly to consumers in 2005. It did, however, claim that they provide “discounts that comply with federal regulations.” As for Amgen, a spokesperson said the company has never used direct-to-consumer marketing to promote its drugs, nor has it given money to physicians to prescribe Aranesp and Epogen.

According to IMS Health, an international, $2-billion-a-year pharmaceutical marketing company, the three products combined had U.S. sales of $10 billion in 2006. From those sales, $700 million in annual sales of the drugs are estimated to come from “off label” (not FDA approved) uses.

SOURCES: FDA, March 9, 2007; http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html;
Lawyers and Settlements, March 27, 2007, http://www.lawyersandsettlements.com/articles/epogen-advertising.html
Aranesp® and Epogen® are registered trademarks of Amgen, Inc.
Procrit®, is a registered trademark of Ortho Biotech Products, L.P. a wholy owned subsidiary of Johnson & Johnson

MDS Pharma Services is a laboratory testing facility located in Canada that is operated by MDS Inc., calling itself a “global life sciences company”, doesn’t produce pharmaceuticals but provides products and services for the development of drugs and the management of disease.

Headquartered in Toronto, Ontario, Canada, MDS is the largest operator of clinical laboratories in Canada. More than half of the company’s revenue is generated in other locations throughout the world, mostly in the U.S. and Europe. MDS generated about $1.5 billion in revenues in the 2006 fiscal year.

FDA inspections of two of MDS Pharma Services’ facilities in Canada revealed a variety of problems with its testing procedures. The company originally agreed to audit its own work, but that failed to satisfy the FDA and prompted the agency to appeal directly to drug makers. The FDA said MDS failed to identify and correct sources of contamination in blood tests that measure drug levels, and failed to validate and document the accuracy of its testing methods.

Cannot identify all affected drugs

Although the FDA says it identified 217 generic drugs tested by MDS that have been approved or are waiting for approval, the agency cannot name (or failed to name) which companies relied on MDS tests for brand-name drugs. The FDA openly declined to identify drug companies known to have contracted with MDS for testing.

As a result, it is notifying all brand-name drug makers that submitted the more than 900 applications received since 2000 to comb through their files to find out what drugs were tested at MDS. The FDA tried to assure the media that it has no evidence of problems with the quality, purity or potency of the affected drugs. And it said the work will not result in the removal of any drugs from the market, but it could slow the approval of some drugs awaiting federal clearance.

SOURCE: http://www.fda.gov/cder/news/pharmaco_studies/default.htm

1) Choose Whole Grains over processed grains. Whole grains still contain the chaff and the germ of the grain. These are the nutrient rich parts of a grain containing a wealth of vitamins and minerals. When a grain is processed, many nutrients are lost such as calcium, B6, iron, niacin, folic acid, fiber, protein, among others. At the same time, ounce for ounce processed grains have more calories. The federal government considered this a big public health issue given that 20% of the calories in the average American diet are coming from processed grains (meaning 20% of the average American diet has very little nutritional value.) Federal law now mandates that processed flour be enriched (adding nutrients back to a food) with iron, niacin, folic acid, riboflavin, and thiamin. Although the federal government recognized that many other nutrients were being lost thru processing grains, they didn’t require enrichment because they argued that you get plenty of these from the rest of your diet. That is true if you eat a diet rich in unprocessed foods such as fresh vegetables, fruits and grains. If you are not, you’re likely facing the dilemma of the average American diet: overfed and undernourished.

2) Choose foods higher in fiber. Whole grains are naturally higher in fiber than processed grains. Fiber isn’t just about “staying regular.” Fiber serves the very important function of slowing down the absorption of glucose into the blood stream and moderating blood sugar levels.

To understand this, we need a brief biochemistry lesson. Carbohydrates can be loosely divided into two categories: 1) sugars – small molecules that the body rapidly absorbs into the blood stream and 2) starches – very large complex and branched molecules that require considerable processing in the small intestine before they can be absorbed. Sugars create a rapid increase in blood sugar which in turn stimulates the pancreas to secrete large amounts of insulin. Insulin moves glucose (blood sugar) out of the blood and into the brain and muscles where it is used for energy. Starches take longer to digest and provide the body with a steadier and more even flow of energy.

We can measure how quickly glucose is absorbed from a food; it is called Glycemic Index. The scale goes from 0-100 with lower being better. Processed grains have a higher glycemic index, for example breads made with processed wheat range from 70-90 GI, while breads made with whole wheat are about 50 GI.

So what does all this mean? If you regularly eat foods high in sugar or processed grains, you can overload your pancreas. Your pancreas will produce too much insulin, blood sugar levels will plummet, muscle begins resisting taking in glucose, and the body begins to store the glucose as fat. The result is you gain weight and you still feel hungry because your blood sugar levels are on a roller coaster. You also put yourself at risk for Type 2 Diabetes, the fastest growing disease in the US. Limiting or avoiding sugars and processed grains is key to avoiding this unhealthy cycle.

3) Choose foods with no added sugars. We have already seen how processed grains affect your blood sugar levels, add sugar on top of that and you have a bad combo. Sugar can appear on a label in many forms: sugar, high fructose corn syrup, brown sugar, maple sugar, dextrose, maltose, corn syrup solids, fructose, sucrose, dehydrated cane juice, can juice, can juice solids, glucose syrup, invert sugar….and that’s just to name a few. Be wary of fruit juice concentrates or “fruit juice sweetened.” These may have started with fruit juice, but they have been processed to remove everything until all that’s left is fruit flavored sugar.

The FDA has set Daily Values on nearly everything in food except sugar. The Center for Science in the Public Interest has petition the FDA repeatedly to set the upper limit for an adult at 40 grams/day. The FDA is lobbied heavily by the sugar industry and so far the FDA has refused to set a Daily Value for sugar. I challenge each of you to tally your daily intake of sugar and see where you fall. Statistics show that Americans get 30-40% of our daily sugar intake from beverages – soft drinks and fruit juices. For American children that number tops 50%! You could do a lot for your health by simply making your beverage of choice water.

BPA can be found in many plastic drinking bottles and even some cans used for storing baby formula. Tony Clement, Canadian Health Minister, stated that most people “need not be concerned”; however “this is not the case for newborns and infants.” Clement further explained that, “We have concluded that early development is sensitive to the effects of bisphenol A.”

The main source of bisphenol A has been determined to stem from transfer from the plastic bottles when boiling water is poured inside as well as the lining of the tin cans in which many baby formulas are shipped and sold. Clement further explained “Although our science tells us that exposure levels to newborns and infants are below the levels that cause effects, we believe that the current safety margin needs to be higher. We have concluded that it is better to be safe than sorry.”

While the Canadian government is already actively warning and taking measures to protect its citizens from bisphenol A, the FDA is being accused by Congressmen of selectively choosing results to support their decision to permit the use in products used by children and infants. An inquiry was launched in January 2008 by Congressmen John Dingell and Bart Stupak into how the FDA’s determined the safety of BPA. April 9, 2008 lawmakers threatened to subpoena the FDA regarding how they made their final decision on bisphenol A. The FDA said that they will respond but not necessarily before they are subpoenaed.

Companies have already started pledging to eliminate the toxic chemical from their products. The popular drinking bottle manufacturer Nalgene announced in an official release that they will be completely phasing out bisphenol A in their Outdoor line of polycarbonate bottles over the next several months. Wal-Mart pledges to remove baby bottles containing BPA early in 2009. Wal-Mart also reminded consumers that they already sell some BPA-free baby bottles.

Sources:
Vancouver Sun
http://www.canada.com/vancouversun/news/story.html?id=9f043e28-3d09-4480-8f03-edac6b0964b9&k=96037
Xinhua
http://news.xinhuanet.com/english/2008-04/16/content_7987681.htm
Royal Society of Chemistry
http://www.rsc.org/chemistryworld/News/2008/April/14040802.asp
Nalgene Outdoor
http://www.nalgene-outdoor.com
Wall Street Journal
http://blogs.wsj.com/health/2008/04/18/wal-mart-nalgene-move-away-from-bisphenol-a/?mod=WSJBlog

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

ADHD is an alleged condition that is said to affect 3 to 7 percent of school-aged children and approximately 4 percent of adults. There is no scientific research actually proving the existence of ADHD as an actual disease or condition. The three main symptoms are inattention, hyperactivity, and impulsivity. People labeled as suffering from ADHD may have difficulty in school, troubled relationships and low self-esteem.

In May 2006, the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The medicines that are the focus of the directive include the following 15 products:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product) Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules

SOURCE: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

According to Public Citizen, the FDA’s Advisory Review Panel recommended label warnings about the dangers of acetaminophen-containing products as far back as 1977, but the FDA chose to ignore the advice.

The Panel’s recommendations were to imprint labels with the following warnings:

• Do not exceed recommended dosage because severe liver damage may occur.
• Do not exceed recommended dosage or take for more than 10 days because severe liver damage may occur.

The percentage of all U.S. cases of potentially fatal acute liver failure associated with the use of acetaminophen rose from 28 percent in 1998 to 51 percent in 2003, according to research figures on one of Public Citizen’s web sites, www.WorstPills.org.

The FDA is also requiring new warnings on nonsteroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen and naproxen, based on evidence available for decades and recommended by the Nonprescription Drugs Advisory Committee in 2002.

“In 2002, we presented testimony to the FDA’s Nonprescription Drugs Advisory Committee showing that the National Hospital Discharge Survey (NHDS) indicated an average of 26,256 hospitalizations and 458 deaths per year related to acetaminophen overdoses,” Dr. Lurie said. “More than half of these overdoses were intentional (mostly suicides), but, at the behest of TylenolTM maker Johnson & Johnson, many measures to prevent intentional overdose were removed from the debate at the 2002 advisory committee meeting, and now from the FDA’s proposed solution to the problem.

“In particular, the number of acetaminophen pills per package should be limited and the number of milligrams per pill should be reduced, as has been done in Great Britain, where some studies show reductions in liver transplants and deaths as a consequence.”

Lurie added that the FDA should also require that advertisements for these pain medications include the warnings, and the agency should make public service announcements to educate the public.

SOURCE: http://www.citizen.org/hot_issues/issue.cfm?ID=1511

The Food and Drug Administration approved Provigil to treat sleepiness in only three sleep disorders: shift-work syndrome, narcolepsy and sleep apnea.

At least half – and some say as much as 90 percent – of Provigil’s sales are for off-label conditions not approved by the FDA. The result is that Provigil and its counterparts around the world have become another “lifestyle drug”, tapping into a huge and lucrative off-label market that its makers have not been unduly keen to discourage.

According to Cephalon’s main Provigil web site, “Provigil is a medication to treat excessive sleepiness caused by certain sleep disorders. These sleep disorders are narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift-work sleep disorder.”

It’s illegal for Cephalon to directly advertise off-label use of Provigil, but Cephalon indirectly creates off-label markets for its drug by funding continuing medical education, where doctors get paid to prescribe Provigil for possible off-label uses.

And Cephalon has another web site called “Alertnessmatters”, which offers such profound and insightful statements as, “Alertness matters because being alert is much more than being awake.” And, “When you’re alert, you may be more focused and better able to pay attention. At work, at home and everywhere else your day takes you — alertness matters.” And to skirt the off-label law, Provigil is never mentioned. Instead, visitors are encouraged to take an alertness test and request more information.

In other words, the company is targeting anyone who probably just needs a nap.

Healthcare “isn’t just another business”

According to 20/20, allergists, internists, pediatricians and even dentists are prescribing the “awake pill.” Dr. Jerome Kassirer, author of On the Take: How Medicine’s Complicity With Big Business Can Endanger Your Health, told ABC News 20/20 that it’s time for drug companies to stop treating health care like it’s just another business: “This is medicine. This is not refrigerators. This is not cars,” he
said. “This is a profession in which we’re taking care of sick people who trust us.”

Kassirer showed 20/20 a journal sponsored by Cephalon called the Primary Care Companion, that is a supplement to The Journal of Clinical Psychiatry. The doctors writing the articles that promoted the off-label uses of Provigil were paid by Cephalon as consultants, speakers and researchers.

And when the U.S. Army’s sleep labs tested Provigil against caffeine, the Army found that Provigil works no better than the caffeine you get in a cup of Starbucks coffee. Soldiers on the battlefield are issued caffeine gum to help them stay awake.

Army scientist Nancy Wesensten said, “The ultimate cure is sleep. Nothing replaces sleep.”

SOURCE: http://www.abcnews.go.com/2020/story?id=2874922&page=1

When Christine Malone’s pregnancy was taking what her medical doctor thought was too long, he decided to induce labor. The drug Dr. Roger Anderson chose to use was one the manufacturer explicitly warned should never be used for that purpose.

According to the Physician’s Desk Reference, Cytotec® was approved by the FDA for the treatment of ulcers. It is never to be used in pregnancy as it can cause abortion and pregnancy complications resulting in maternal and fetal death.

As a result, Ian’s short life was downright tragic. He suffered severe brain damage at birth. His problems included not being able to hold his head up, suck, swallow or gag properly, and he required 16 hours or more of nursing care daily. He got nutrition through a feeding tube in his abdomen, breathed with a ventilator, took medication daily to prevent seizures and needed a sedative to sleep.

That the drug Cytotec was administered to Ian’s mother was a definite blunder. Equally disturbing is the fact that the obstetrician, Roger Andersen, was even allowed to be practicing medicine at the time of the incident. He had an open investigation against him by the state of Washington, and his work privileges had previously been restricted by his hospital, Providence Seattle Medical Center. He had been required to participate in a monitoring and proctoring program regarding his obstetrical patients. He had also received repeated warnings regarding his failure to establish safety protocols for his midwife patient referrals, which Christine was.

Dylan and Christine Malone, Ian’s parents, have undergone much personal sacrifice in their crusade to bring greater attention to medical malpractice issues. They want to ensure that other families do not suffer through the same kind of negligence that stopped Ian’s life so short. They have created a website, www.babyian.com, to share Ian’s story and to educate the public about healthcare reform.

SOURCE: www.centerjd.org/stories/Malone%20Obit.html

The study was developed by the federal Centers for Disease Control and Prevention, the Food and Drug Administration and the United States Consumer Product Safety Commission. It looked at 63 hospitals in 2004 and 2005. It found that
people over 65 faced the greatest risks.

The 2-year study found 21,298 adverse drug event cases were reported in the sampling group. Taking those numbers  nationally, the researchers estimate that 701,547 individuals suffered adverse drug reactions serious enough to require hospitalization.

The study found that a small group of pharmaceutical drugs were most commonly implicated, including insulin for diabetes, warfarin for clotting problems, and amoxicillin, a penicillin-like antibiotic used for all kinds of infections.

Lead author Dr. Daniel Budnitz, a medical epidemiologist at the Centers for Disease Control and Prevention’s National Center for Infectious Diseases said: “Actually, it is most likely an underestimate. It might just pick up a third of the emergency visits — the number could be much higher. We don’t know how much, but we are confident that there were at least 700,000 emergency department visits.”

Dr. Budnitz added, “Many of these events, especially the most severe — are due to this handful of drugs that we already knew we needed to closely monitor.”

Authors of the study concluded, “Adverse drug events among outpatients that lead to emergency department visits are an important cause of morbidity in the United States, particularly among individuals aged 65 years or older. Ongoing, population based surveillance can help monitor these events and target prevention strategies.”

SOURCE: www.kidchiropractic.com