Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, October 1, 2010

Conventional Weight Loss

Conventional wisdom while conventional might not always be wise. Were constantly being told that exercise and weight loss is the way to a healthier life. The research that we seek out or are directed to discover is when the research is correct and how that research is reported incorrectly. The founders wife asked us to look into a report that people with type 2 diabetes didn't have to exercise to loss weight. Our kind of story. That's not what we found. Instead we found that "Intensive lifestyle intervention can produce sustained weight loss" which is the traditional party line. Exercise and lose weight - there is no other way that takes it off and keeps it off according to the four (4) year study. We did find this information.
"Lower Fat Diet in Diabetes - There are today three distinct views concerning the proper diet in diabetes. One group of workers believes that carbohydrates should be kept at a point believed to represent glucose tolerance of the patient. The second group advocates a high fat, non-ketogenic low carbohydrate diet. The third group, holding the most recent views, advocates what seems like a very high carbohydrate and low fat diet. All agree upon the desirability of avoiding ketosis, meeting caloric needs and supplying the patient with a physiologic diet. - Annals of Internal Medicine (December 1930)
Conventional wisdom from the best minds of their time. To that end we offer you this latest information from the best minds of our time. Think of information and research as more round earth theory than flat earth theory. We think that if you're still alive at the end of the day you're ahead of the game. This doesn't mean that we think that the idea of exercising to lose weight is a flat earth theory we don't.  We can hope and pray but we know that that won't necessarily make it so.
"Low-Carbohydrate Diets and All-Cause and Cause-Specific Mortality - A low-carbohydrate diet based on animal sources was associated with higher all-cause mortality in both men and women, whereas a vegetable-based low-carbohydrate diet was associated with lower all-cause and cardiovascular disease mortality rates." - Annals of Internal Medicine (September 2010
What a difference twenty-three (23) years and over one hundred twenty-nine thousand seven hundred and sixteen (129,716) people later. We know more today than we did eighty (80) years ago. We know more or do we? The research numbers are difficult to dispute when they're so large and comprise two (2) studies and not one (1). What a difference a millennium and computers make.
"...a doctors group seeks to compel the agency to alert patients to safe dietary alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart failure, and death. The nonprofit Physicians Committee for Responsible Medicine (PCRM) is filing the suit in the U.S. District Court for the District of Columbia. The lawsuit targets FDA commissioner Margaret Hamburg, M.D., for failing to act on a PCRM administrative petition urging the FDA to require that diabetes drugs carry warning labels telling patients that low-fat plant-based diets can effectively treat type 2 diabetes without dangerous side effects associated with oral medications." - Physicians Committee for Responsible Medicine (PCRM) July 2010 
When we reported on the pine bark extract research were news reports cited its supposed ineffectiveness we call your attention to Food and Drug Administration (FDA) approved drugs that are dangerous and deadly rather than possible useless. We maintain that while the Japanese pine bark extract might have been useless in the application tested that misuse of any medication generally renders it ineffective.
"AVANDIA may increase the risk of heart problems related to reduced blood flow to the heart. These include possible increases in the risk of heart-related chest pain (angina) or "heart attack" (myocardial infarction). This risk seems to be higher in patients who took AVANDIA with insulin or with nitrate medicines. Most people who take insulin or nitrate medicines should not also take AVANDIA. If you have chest pain or a feeling of chest pressure, get medical help right away, no matter what diabetes medicines you are taking. Patients with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol." FDA (February 2008
We reported on the complaint that the Food and Drug Administration (FDA) had against POM the "pomegranates and pomegranate-based products" company and we were against it. We support the FDA in it's efforts to protect "the public health" we just think that going after this one privately held company isn't necessarily in that interest. We could be wrong and POM might have been asking for it since they did sue Minute Maid. Not that there's anything wrong with it! We just don't like lawsuits.
"Protecting the food supply, making it safe, making it nutritious, is one of the most fundamental duties of government," says Michael R. Taylor, Deputy Commissioner for Foods at the FDA. He explains that for a hundred years the public has really depended upon FDA to prevent foods from being contaminated and to set standards for labeling foods to help people know what they are buying and hopefully choose healthy diets. But the Office of Foods, created in 2009, came into being as a response to new challenges involving the food supply. The new emphasis, says Taylor, is on implementing "common sense measures" to prevent problems before they occur." - FDA Basic Video (Food Safety and Nutrition
You can watch the video of DC Michael R. Taylor in his own words describing the Food and Drug Administration's position and purpose. The FDA is the last line of federal defense against hucksters and snake oil salesmen that seek to separate you from your money and can endanger your health. We worry like the PCRM agency gives too much levy way to big businesses at the expense of the individual. Not always and not as a matter of policy. Sometimes lives are put at risk and when they are we're here to say: "Don't Do It!" If and when necessary - which we presume will be few and far between. Mostly we're here to say don't wait for the dead and dying.
"24-Week Phase 3 Study Found Investigational Drug Dapagliflozin Improved Glycosylated Hemoglobin (HbA1c) When Added to Glimepiride in Adults with Type 2 Diabetes Mellitus - The study also demonstrated that dapagliflozin plus glimepiride achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test (OGTT) and fasting plasma glucose (FPG) levels from baseline at week 24 compared to placebo plus glimepiride." - AstraZeneca (September 20, 2010
Okay this is awkward. We've said what we said and then we drop this bit of news on you. So let's just say it now. That the preceding statement has little to do with the aforementioned quotation. It's just where it fit into the story. We will however include both good news and bad news about the "less exercising better results" product simply as a matter of information. We aren't making any judgments on the product. Twenty-four (24) weeks and almost six hundred (597) patients discovered that "dapagliflozin plus glimepiride" achieved reductions and this is an amazing research revelation revealed at the European Association for the Study of Diabetes in Stockholm this week. Now if someone decides to test the new drug WITHOUT glimepiride which should result in no reductions that will mean it's ineffective. Unlike pine bark extract which is relatively harmless while the new drug dapagliflozin is anything but harmless.
"New Diabetes Drug Dapagliflozin Closer to Approval - Generally, the occurrence of side effects was about equal across all four groups. Rates of genital infections were higher among patients treated with dapagliflozin than those taking placebo, but the infections were mild and did not cause any patients to withdraw from the trial." - Emax Health (October 2009
We are not anti-perscription drug. Remember what we said earlier. If you're still alive at the end of the day you're ahead of the game. We want you ahead - not dead. Food and Drug Administration (FDA) approved drugs can put your tomorrows at risk. Sometimes this federal organization has to be forced by lawsuit to do what's best for you and we. Given the choice of treatment between Dapagliflozin, pine bark extract or bariatric (weight loss surgery) operations we'd choose the first two (2) rather than the latter.
"Risk of Suicide after Long-term Follow-up from Bariatric Surgery - Compared with age and sex-matched suicide rates in the US, there was a substantial excess of suicides among all patients who had bariatric surgery in Pennsylvania during a 10-year period. These data document a need to develop more comprehensive longer-term surveillance and follow-up methods in order to evaluate factors associated with postbariatric surgery suicide." - The American Journal of Medicine (September 2010
Weight loss surgery might seem to be the easiest solution to the problem of obesity because you just lie back and let the surgeons cut away while dreaming dreams of sweetness and light. You awaken and hopefully be lighter while feeling so much better ignoring the ugly scars that indicate the procedure. There's a real couch potato feeling to it with one research demonstrated downfall. It could be that Pennsylvanians are more susceptible than other citizens but when the surgeries are in excess of sixteen thousand (16,683) the numbers are difficult to dispute or ignore.

Tuesday, September 28, 2010

Programmed Salmon

When man doesn't act science fills the gap. It'll be more than the price of fish that critical ingredient to health according to every research known to man. We love all things natural but there are consequences and repercussions for our actions. Remember that 3rd law of Newton that we're so fond of. (Hey we're on a theme!)
"Tuna on the endangered list - Illegal fishing has depleted global stocks of tuna and governments must take bold action to save some critically endangered species, the conservation group WWF said Monday as a conference on the topic opened in Japan. Japan's insatiable appetite for tuna has been a key factor behind the threat to stocks, and now increasing demand from other countries is adding to the pressure." - NY Times (January 22, 2007)
One of the consequences of our OVER fishing and depletion of food supplies means more than shortages and high prices. It can result in the repercussion of poor health and diseases of old and conditions long since cured and eliminated. That however is negative doomsday thinking and while some of us live to think it others of us feel as though its too much of a downer. So with that in mind lets go to professionals.
"Continued mismanagement could force some tuna populations to quickly go the way of cod, a highly threatened fishery that once helped shape economies of whole nations, leading scientists said in the symposium “Last Best Chance for Tuna: Learning from the Cod Collapse” at the American Association for the Advancement of Science (AAAS) Annual Meeting in Boston on February 18." - World Wildlife Fund (Feb 19, 2008)
Okay so you say that's tuna and not salmon. We wish!. You see the fish that are tuna, are in the sea, well, ocean but you get our drift. Unfortunately close to home things are not that much better either. Indeed they have not been that way for some time now. So before you get all high and mighty we call your attention to this bit of historical information.
"Currently populations of salmon, steelhead, trout, and rockfish are listed as endangered or threatened in the state of Washington." - Municipal Research and Services Center (March 1999)
We don't really NEED fish to survive do we? We that depends on what you mean by survive. You've heard that we have this health care thing going on haven't you? Fish isn't important if your in great health and you exercise regularly and we've got enough stored vitamins and nutritional supplements for the next millennium.
"Some fish (such as salmon, trout, and herring) are high in a type of PUFA called “omega-3 fatty acids.” The omega-3 fatty acids in fish are commonly called “EPA” and “DHA.” There is some limited evidence that suggests eating fish rich in EPA and DHA may reduce the risk for mortality from cardiovascular disease. (EPA is eicosapentaenoic acid and DHA is docosahexaeonoic acid.)" - USDA (MyPyramid)
In any event we haven't heard the last word on the subject of genetically modified (GM) salmon eggs that grow faster than the naturally farm grown variety. Unfortunately Canada has said that their GM salmon has escaped into the wild and you know how indiscriminate those fish are. They've probably already mixed their scientific genes with those natural ones - except among the tank raised variety! Gives a whole new meaning to the term farm fresh doesn't it!

Wednesday, August 25, 2010

Sick Food

We wrote this article before the Center for Disease Control and Prevention (CDC) released their information on 2007 we repeat back, when there was another president and some three (3) years ago and the situation that you did not know (and neither did we) was pretty bad. Sorry we didn't tell you sooner.
The study, Health-Related Costs from Foodborne Illness in the United States, was written by Dr. Robert L. Scharff, a former Food and Drug Administration (FDA) economist and current Ohio State University assistant professor in the department of consumer sciences. The study estimates that more than a quarter of these costs, an estimated $39 billion, are attributable to foodborne illnesses associated with fresh, canned and processed produce. The FDA has announced that it will propose before the end of the year mandatory and enforceable safety standards for the growing, harvesting and packing of fresh produce. These will be the first nationwide safety standards for fresh fruits and vegetables. - Produce Safety Project (PSP)
You can view the entire PDF at this link! If you can to know where the information comes from. You can read it yourself.
The survey was commissioned by the Produce Safety Project (PSP), an initiative of The Pew Charitable Trusts at Georgetown University, and conducted by Safe Tables Our Priority (S.T.O.P.). Thirty-nine of the 51 state and District of Columbia health departments responded to the survey, which asked about the types of questions and questionnaires administered to victims of foodborne illness, the time frame in which they were completed, and how states collected and stored the resulting data for calendar year 2007. Despite the increase in the number of multi-state outbreaks of illnesses linked to fresh produce over the past several years, the data show that only 25 of the 39 states responding to the PSP/S.T.O.P. survey asked victims about specific produce items - even if the item was associated with a past outbreak. "It is important to learn from our experience, and so it is surprising that many states are failing to ask about fruits and vegetables on their questionnaires given to foodborne illness victims," said Jim O'Hara, PSP director. - Produce Safety Project (PSP)
We knew the problem was bad some months ago. There is a difference between knowing three (3) year old information and knowing information that will be reported as bad some years later. Ideally the goal would be to act before the problem becomes a problem as the government did with the swine flu that we were so hyped because we didn't think the numbers of dead and dying were acceptable even though the government and local health departments didn't seem alarmed.
In September 2008 a survey conducted for PSP that people were concerned about safe food and believe their concerns are serious.
In November 2008 they released a report about lessons that could be learned from the Salmonella Saint Paul outbreak of 2008.
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) declared the Salmonella Saint Paul outbreak of 2008 officially over on August 28, 2008, some three months after it began. During that time, more than 1,400 persons were reported infected, and if, as suggested by research, this represents an underreporting, [1] the outbreak may have sickened thousands of Americans. Although CDC and FDA initially pointed in early June to tomatoes as the cause of the outbreak based on epidemiological data, no contaminated tomato was ever found. In July, CDC and FDA identified jalapeno and serrano peppers as being responsible for illnesses, and the only microbiological evidence of food contaminated by Salmonella Saintpaul was, in fact, found in jalapeno and serrano peppers.[2] However, as a result of the initial identification of tomatoes as the vector for the disease, the tomato industry, a significant sector of this country's agriculture economy, was another major casualty. Estimates of the economic cost to that industry in Florida alone have been more than $100 million and in Georgia close to $14 million. [3] A less tangible, but still very real, impact of the outbreak may well be its long-term effect on consumer confidence in fresh produce in general and fresh tomatoes in particular. - Produce Safety Project (PSP)
You'll be glad to know that this isn't the end of the story. The government is on it - albeit three years later but lets let everybody calm down. Take a deep, nevermind! Let's just drink a glass of water, eat a piece of chocolate with a bowl of berries or deep vegetables.

Monday, February 22, 2010

Black Heart Health Month

February is considered by many to be Black History Month when many African American churches and organizations recognize the contributions made by many historical figures of African American descent. This year includes many health related concerns and issues as part of their celebratory events. Just in our jurisdictions along were these events:
According to Kelly Morin, director of marketing and physician relations at Saint Agnes, the event educates women about maintaining their hearts physically and spiritually. “Our mission is to educate women, specifically African-American women, about the risk factors of heart disease and the behaviors and conditions that increase their chances,” said Morin. Throughout the day, church leaders will supply worshippers with information regarding heart disease prevention and many churches will also provide free health screenings. (Maryland)
One of many events available this month in the nation's capital include:
SEIU/CIGNA Healthcare Health Fair. John D. Ruffin, Ph.D., the Director of the National Center on Minority Health and Health Disparities at the National Institutes of Health will be on hand to lead a discussion about the several medical conditions afflicting Americans at large. Insurance provider CIGNA Healthcare is providing information and health screenings as part of the event. Howard University and Washington Sports Clubs are also participating. -(DC)
Even in the tarheel state churches included health information and screenings as part of their "African American History" programs:
It’s a celebration of African American History at the Koinonia Church in Greenville, and there’s no shortage of things to do.“We have had education through exhibits, we’ve had entertainment, we’ve had musical entertainment, and health screens, specifically screenings that are important to the African American community. We’ve also had some great food - just a lot of fun in celebration of Black History,” said Theresa Holley. - WNCT TV 9 (North Carolina)
We included this bit of information from our US Food and Drug Adminstration (FDA) concerning information released in reverse. According to the New York Times, which has obtained an advance report concerning the possible recall of a diabetes medication by the FDA. What does that have to do with Black History Month? High blood pressure (hypertension), cardiovascular disease and diabetes all affect the African American community in disproportionate numbers contributing to premature, preventable andunnecessary. Maybe the FDA doesn't want to interrupt Black History Month with the warning.
After carefully reviewing several sources of study data, FDA concluded there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Because available data are inconclusive—studies have neither confirmed nor excluded the risk—FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks. - FDA (Nov. 14, 2007)
Slow to act the U.S. Food and Drug Administration (FDA) knew long before they considered releasing a warning to "we the people" some almost two years later. "Two drugs used to treat Type 2 diabetes have been found to cause or worsen a serious vision impairment known as macular edema, Health Canada warned Wednesday. The advisory was released after GlaxoSmithKline Inc., the manufacturer of Avandia and Avandamet, informed Health Canada of reports that some diabetics on the drugs had developed the eye condition or had a pre-existing case worsen." (Dec 2005)

That the company released information about their own research at the same time that the Canadian government released an advisory for the medication for which it was developed may seem suspicious but that's true for all dependent research.
"Glaxo undertook a study of 500 patients with mild forms of Alzheimer's who were being treated in Europe and New Zealand. After six months, Avandia showed no benefit when compared with a placebo. When Glaxo separated patients on the basis of their genetics, it found that those who didn't have the type 4 variant of the gene showed a ``statistically significant'' improvement in memory." - The Pharmacogenomics Journal (Dec 2005)
While releasing information on the European and New Zealand study at the same time in Winston Salem a study was just beginning to determine the effect of the drug on adults 21-65 years of age who had been taking only Avandia for at least three (3) months advertising for participants in the local newspaper called: The Dispatch (Lexington, NC)

We don't know the results of this study but we do know that the participants received $375 and something as unclear as "study related care and study medication at no charge." It's not clear if this is the same thing as free health care but maybe that's implied. What's most interesting is that in February of the same year the drug Avandia was licensed for use as part of "triple therapy in combination" with two (2) other drugs. This was the case some ten (10) months prior to the study being undertaken in Winston Salem, NC where the individuals selected for the study could not be taking any other medication.

The New York Times has obtained internal reports from the Food and Drug Administration (FDA) that have not yet been released to the public. A search of the FDA website reveals no new specific information so we will just have to take the NY Times word for it. What we should learn from this African American History Month is that the history of the FDA is too little critical health information provided too late. If history of the African American experience tells us anything is that to wait can be too late. "How long? Not long, (Yes, sir) because "no lie can live forever."

Saturday, February 20, 2010

Everything but the Zinc

The news on TV and on the web was that the makers are pulling their products from the market but what the stories don't tell is how soon they knew before they acted to pull their products from the market. That's the real news story. It wasn't that the manufacturers didn't have enough time and warning to know about their product. Research shows that they did know and until now denied the charges.
zinc free denture cream
"Man claims Poligrip caused neuro damage - A man who used a denture adhesive now claims the zinc in the product caused neurological damage and has filed suit against the manufacturer. Smithkline Beecham Corporation, maker of Poligrip, is named as defendant in an East Texas civil action lawsuit filed on Tuesday, July 31. Through normal and regular use of Super Poligrip Denture Adhesive Cream, plaintiff William Walker alleges injuries which include neurological damages. The complaint states the product did not contain warnings or instructions regarding the hazards of ingestion and absorption of zinc.Plaintiff's attorney Casey Carlile of Marshall, Texas states Walker's injuries and their relationship to Poligrip were "inherently undiscoverable" and therefore, the discovery rule should not be applied until "discovery of Defendant's tortuous conduct." SE Texas Record (8/2007)
Before there was a lawsuit there were cases from individuals that we would call "canaries" that alerted individuals to dangers that could cause serious injury to users. This is before the Food and Drug Administrations (FDA) acted in the public interest, or should we say reacted in the public interest.
"Everything in moderation -- even denture cream. - You wouldn't think of it as being hazardous to your health -- but in high amounts, it could be - at least according to handful of individual reports, highlighted in the journal Neurology. "In these four patients, they had neurological disorders and had been using high levels of denture cream, denture adhesive," says Dr. Marc Samuels, a dentist at Allegheny General Hospital. The issue is what's in the denture cream, namely, zinc and copper, which in the wrong amounts can be bad for your nerves -- with poor balance, hand weakness, confusion, and even bladder accidents." (KDKA TV  9/2009)
One of the reasons we focus on the scientific study and research is because of the specific knowledge derived from specific research. If we seem critical of our FDA its because of the slowness of their responses than to any feelings of mistrust.
Center for Science in the Public Interest (CSPI) has long sought to educate the public, advocate government policies that are consistent with scientific evidence on health and environmental issues, and counter industry’s powerful influence on public opinion and public policies. (CSPI)
We love the CSPI! We don't always agree with them but as a source of scientific information we them. We don't often quote them and when we do we'll highlight that it's from the Center for Science in the Public Interest. For the FDA an "event" is registered when a lawyer advised the Food and Drug Administration that a problem has occurred. For instance an attorney registered a MAUDE (Manufacturer and User Facility Device Experience) in November in 2005. Now we ask you, should you have to wait until four (4) years later to receive vital health information?
This care was reported by a lawyer and verified via medical records and described the occurrence of heavy metal poisoning in an adult female pt who used poligrip denture adhesive cream for dentures. The pt's past medical history included kidney stone. Concurrent medical conditions included hypertension. In the complaint, the reporter (lawyer) alleged that the complainant, an adult female, experienced heavy metal (zinc) poisoning and neurologic insult as a result of absorption and ingestion of poligrip. A physician or other health care professional has not verified this report. The outcome of the events is unk. (MAUDE Adverse Event Report)

We think the answer to that question is never. Information is power and vital information is a matter of life and death.

Saturday, November 7, 2009

Flop Flop Fizzle Fizzle

Oh, what a rippoff it is. When the safe and effective turn out to be unsafe and ineffective with lethal consequences we've got problems. When it comes to over the counter and prescription medications for gastroesophageal reflux disease (GERD) what you get isn't always what's good for you. US News & World Report reports that: "In 2008, proton pump inhibitors were the third largest-selling therapeutic class in the United States, ringing up $13.9 billion in U.S. sales, according to IMS Health, a Norwalk, Conn.-based health-care data company. With 113.4 million prescriptions, they were the 6th most widely dispensed retail prescription medications, IMS reported."

The recently released research in this month's American Academy of Otolaryngology -- Head and Neck Surgery was presented at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery, San Diego, CA, October 4-7, 2009. The research precedes the release of Dr. Jonathan Wright's book: "YOUR STOMACH: WHAT IS REALLY MAKING YOU MISERABLE AND WHAT TO DO ABOUT IT" which finds that: "Shockingly, the problem may not be too much stomach acid, but too little! Stomach and other maladies—heartburn, bloating, constipation, and indigestion—may all be the result of too little acid. Antacids and acid blockers may be making the problem worse."

Consumer Reports reported Proton pump inhibitors or: "(PPIs) have been heavily promoted, which has led to overuse in people with garden-variety heartburn. Nexium, one of the most widely-prescribed PPIs is also the most expensive at $240 per month (the cash price you would pay if your insurance did not cover it). Not surprisingly, Nexium was also a top-selling drug in 2008 at a whooping $4.8 billion."

When things are considered safe and effective you don't expect anything else. The question we posed to the FDA is how the heck can that happen especially in a billion dollar industry whose product is not safe or effective. MEDIndia reported this about the study: "PPIs are not effective at treating all cases of gastroesophageal reflux(GERD) and laryngopharyngeal reflux (LPR). In addition to the evidence that acid isn't the only contributing agent in reflux disease, the new study has revealed that there are many unexpected consequences and side effects from this class of drugs."

Until release of the research all news focus has been on the cost to consumers and relative ineffectiveness of the available consumer products both over the counter and prescription. We replaced the loud commercial ridden news report by NBC 9 News Colorado and replaced it with a Consumer Reports video. This another of the studies that demonstrates harm caused by use. While U.S. Food and Drug Administration (FDA) has begun its "Safe Use Initiative" the concern for drugs considered safe and effective that are neither creates a category not likely considered in a cooperative public and private interest environment. With this much money at stake in this financial environment decisions are not likely to fall in favor of the consumer. Be warned. Be forewarned.

Thursday, October 8, 2009

Attack of the Killer Tomatoes

We had to do this story because it was just too easy. Doing this story we discovered a quartet of Killer Tomatoes films. Including the sequel we never saw that co-starred a young George Clooney. We know it's yesterday's news but Attack of Killer Tomatoes is a movie from yesteryear. While the tomatoes may be killers they only made us sick.

In the current criticism of the government we acknowledge that the government can't do it all. Our question is when the government doesn't why didn't they. We're all human and everyone makes mistakes. It's easier to forgive someone who in the course of the job overlooked something that they normally wouldn't. When this comes to food products this is a challenge. However if a problem is pervasive and there is an obviously omission done for financial concerns rather than health. Then "Houston, we have a problem!"

The following top ten list is from the Center for Science in the Public Interest (CSPI - video). A real group with real interests in the public's health, safety and welfare. It's a not for profit organization that checks to make certain that the mistakes aren't financial.

tuna saladWedMD is a for profit organization that challenges the data and the results. "Foods like potatoes are almost always consumed cooked, so it is unlikely that potatoes themselves caused 108 outbreaks." Which ignores what the report (PDF) from the CSPI says. To which we remind WedMD and you that potatoes aren't purchased cooked. With the proliferation of the microwave oven that speeds the time for eating into minutes adequate cleaning isn't always the priority.

Illnesses caused by these ten foods may be as minor as stomach cramps and diarrhea for a day or two, or as serious as kidney failure or death. Notably, pathogens most commonly associated with meat and poultry—such as Salmonella2 and E. coli O157:H73—also have been repeatedly linked to these food items. In fact, Salmonella was identified as the cause in 33 percent of the outbreaks from the FDA Top Ten. Other pathogens causing the outbreaks associated with these foods include Campylobacter, Scombrotoxin, Norovirus, and Vibrio.4

 #  FOODTYPE  OUTBREAKS  ILLNESSES  #  FOODTYPE  OUTBREAKS  ILLNESSES 
 01  Leafy Greens  363  13,568  06  Cheese  83  2761 
 02  Eggs  352  11,163  07  Ice Cream  74  2594 
 03  Tuna  268  2341  08  Tomatoes  31  3292 
 04  Oysters  132  3409  09  Sprouts  31  2022 
 05  Potatoes  108  3659  10  Berries  25  3397 

"Outbreaks give the best evidence of where and when the food safety system is failing to protect the public," said CSPI staff attorney Sarah Klein, the lead author of the report. "It is clearly time for FDA's reliance on industry self-regulation to come to an end. The absence of safety plans or frequent inspections unfortunately means that some of our favorite and most healthful foods also top the list of the most risky."

"As consumers, we don't have the power to check on these products," said Kathleen Chrismer, whose 9-year-old daughter Rylee Gustafson was hospitalized for a month after becoming seriously ill from eating spinach salad contaminated with E. coli O157:H7. "Without a better system to protect us, we are totally at the mercy of the next outbreak."

We found the source of our sickness. We didn't make a report so we're certain that the reported numbers are substantially under reported. Indeed what's missing from the reports from both the CDC, CSPI and the FDA is a procedure for reporting illnesses. The reason, in our view, reports are made by hospitals and other medical facilities. Our take is that the illness reports from the public are discouraged. In this according to opponents to public options its the lawsuits that increases the cost health care. To us the solution is simple - have a public options for doctors AND patients.

Wednesday, September 2, 2009

Breast Life

This story had it all. It's not as recent as the Federal Drug Administration (FDA) Advisory Group refusing two new cancer drugs for seniors but this story has breast cancer, minority women and survival rates. How could we not focus on the mailed survey results of the over thirty-one hundred (3133) "Latina and African American women"? Their conclusion: "Greater patient involvement in decision making was associated with receipt of mastectomy for all racial and ethnic groups. Patient attitudes about surgery and the opinions of family and friends contribute to surgical choices made by women with breast cancer." In the WebMD story young women afraid of dying from breast cancer opt for a radical mastectomy and the older women with family involvement choose "breast-conserving surgery."
breast cancer
Unfortunately for our Aunt Pearlie and many women seniors a lump means cancer, means never leaving the hospital and means death. The big "C" (cancer) fear is the earliest of our AIDS, terrorism, swine flu for the generations.

As the health care debate rolls on in the media at the very same "Journal of the National Cancer Institute" you can listen to the nine minute fifty-six second (9:56) interview with Dr. Peter Bach of the Memorial Sloan-Kettering Cancer Center discussing the issue of treatment and health concerns being waged out of patient earshot and awareness - "How much is life worth?" It's being called the $430 Billion Dollar Question. The podcast is in the very same issue as the study from the August issue of the journal. For many seniors with a healthy, active lifestyle and strong family ties the answer is priceless. Unfortunately when pain and inoperable medical conditions apply many individuals like Pearlie Mae Leach decide the answer is a financial concern.

Friday, August 28, 2009

Now This is OUR FDA!

The FDA (Food and Drug Administration) they're reviewing information from outside the US as well as responding to problem within the US. This is what we want the FDA to do. When we questioned the FDA of the policy for topical Ibproven and suggested that the FDA simply fine someone who doesn't dot their "i"s and cross their "T"s. We were told by the that FDA doesn't have that power. When we saw that the US News and World Report and Wall Street Journal said that the FDA was warning users of the Alli weight loss products we began our search.

Our FDAWhat we found was this: "Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases."

"...FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite. FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program using the information at the bottom of the page."

When the FDA responded to our queries they said they don't have the power to fine companies and that companies need to comply with their rules and regulations. They didn't address the issue of whether or not they received complaints in reference to topical ibproven use which doesn't seem to fit their definition of a new drug in our estimation. We're still waiting and seeing what they're response to those specific questions.

Monday, August 3, 2009

Clean Hands - WARNING

The list of hand sanitizers that are being recalled and should be discarded according to the FDA are:

• Citrushield Lotion
• Dermasentials DermaBarrier Clarcon Labs
• Dermassentials by Clarcon Antimicrobial Hand Sanitizer
• Iron Fist Barrier Hand Treatment
• Skin Shield Restaurant
• Skin Shield Industrial
• Skin Shield Beauty Salon Lotion
• Total Skin Care Beauty
• Total Skin Care Work

We use them in the powder room that doesn't have a sink and buy ours from the local dollar store. Our brand? Instant Hand Santizer distributed by Family Dollar and from Garcoa Labs California. The FDA says that Clarcon VOLUNTARILY recalled their products but The Atlanta Journal-Constitution reported: "U.S. Marshals Service officers seized all skin sanitizer and skin protectant products, including ingredients, at Clarcon's facility in Roy, Utah, the Associated Press reported. The seizure took place after Clarcon didn't comply with an FDA order to promptly destroy the products."