FDA Corruption Complaint to Obama

FDA scientists complain to Obama of 'corruption'

Associated Press
By RICARDO ALONSO-ZALDIVAR – 3 days ago

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

FDA spokeswoman Judy Leon said in response: "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency's reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along," the letter said.

A spokeswoman said the Obama transition team had no comment.

Plastics Chemical Linked to Disease in Adults

From Newsmax Health

Bisphenol A or BPA, a chemical found in plastics, has been linked to some of the most deadly and rapidly increasing medical conditions in American adults.

A research team from the University of Iowa, the Peninsula Medical School, the University of Exeter, and the University of Plymouth found evidence that links BPA to heart disease and diabetes in adults. BPA, which is used in polycarbonate plastic products such as refillable water bottles, some plastic eating utensils, compact disks and many other everyday products, is one of the world’s most widely-used chemicals.

Earlier studies in mice and rats shown that exposure to BPA could lead to diabetes, liver damage, obesity, and insulin resistance. Earlier this year, experts raised the concern that BPA could leach into plastic baby bottles and cause developmental and reproduction problems.

The current research, which examined a representative group of 1455 adults between the ages of 18 and 74, found that the 25 percent with the highest concentration of BPA in their urine were more than twice as likely to have heart disease and diabetes as the 25 percent with the lowest BPA levels.

“Our study has revealed, for the first time, an association between raised BPA loads and two common diseases in adults,” said Professor David Melzer, professor of Epidemiology and Public health at the Peninsula Medical School who lead the team. At the moment, we can’t be absolutely sure that BPA is the direct cause of the extra cases of heart disease and diabetes. If it is, some cases of these serous conditions could be prevented by reducing BPA exposure.”

Chlorine in Tap Water Doubles Birth Defects

Chlorine is one of the 2 biggest health threats in our drinking and bathing water. Fluoride is the other super toxic waste byproduct disposed of in our drinking water under the guise of unproven dental decay reduction. Fluoride is an effective rat poison though.

Drinking, bathing and breathing the fumes of chlorine and it's byproducts are extremely detrimental to living organisms (we are living organisms aren't we?). Chlorine is a pesticide. It kills bacteria and any other living cells too.

What is different over the last hundred or so years that is causing all these diseases, conditions and overall degradation of health? Could chlorine and fluoride be 2 of the biggest offenders?

Following is from NewsMax.com Health Alert:

=====================================================

Pregnant moms who live in areas where the drinking water has high levels of chlorine almost double their risk of having babies with birth defects, including heart problems, major brain defects or a cleft palate.

The threat to unborn babies is caused by chemical by-products called trihalomethanes, or THMs, which are formed when chlorine is added to water. THMs can be absorbed through the skin and then pass into the womb. Moms can expose their babies to the dangers of chlorine by drinking tap water, bathing, or simply standing close to boiling water.

Scientists at the University of Birmingham analyzed the birth records of almost 400,000 babies. They found that anencephalus (partial or complete absence of brain and spinal cord), hole-in-the-heart, and cleft palate increased between 50 and 100 percent in areas where the drinking water was heavily chlorinated to disinfect it. The risk of urinary tract defects and Down’s syndrome was also raised.

Earlier studies have linked chlorinated water to other problems, including stillbirth, miscarriage and bladder cancer.


Also see Heart Disease

What's Worse - The Condition or Side Effect?

We have all seen the pharmaceutical commercials where the list of side effects is 10 times worse than the condition it is "treating". Does anyone have any common sense left or are we all brainwashed to believe everything they are told by TV and doctors (and TV doctors)?

The media couldn't be biased towards their largest revenue source (pharmaceutical advertising) could they? Why are the same pharmaceutical drugs more expensive in the USA than EVERY OTHER COUNTRY? BECAUSE THEY GET IT. Our laws and socialized medicine (Medicare and other welfare programs) allow it. Who's the chump here? We all are.

From Healthmad.com

http://www.healthmad.com/Medicine/Prescription-Drugs.95408

Terrifying Side Effects of Prescription Drugs

Here are 25+ terrifying side effects that can be caused by prescription drugs.

Reading or hearing about side effects of prescription medication can sometimes be horrific. I often wonder if taking the medication to ease a condition is worth the risk of experiencing some of the awful side effects that come with medicine. The following is a list of some of terrifying side effects that come with many prescription drugs currently on the market.

* Drainage, crusting, or oozing of your eyes or eyelids
* Swollen, black, or "hairy" tongue
* Changes in the shape or location of body fat
* Decrease in testicle size
* Sores or swelling in your rectal or genital area
* Blue lips or fingernails
* Purple spots on the skin
* White patches or sores inside your mouth or on your lips
* Irregular back-and- forth movements of the eyes
* Enlarged breasts in males.
* Unusual risk-taking behavior, no fear of danger
* Extreme Fear
* Hallucinations, fainting, coma
* Fussiness, irritability, crying for an hour or longer
* Paralysis
* Thoracic Hematoma (bleeding into the chest)
* A blood clot in the lung
* Liver damage
* Kidney damage
* A lump in your breast.
* Decreased bone marrow function
* Congestive heart failure
* Shingles
* Nerve pain lasting for several weeks or months
* Bleeding that will not stop
* Coughing up blood or vomit that looks like coffee grounds

Finally, there is one drug on the market, EvaMist, which includes all of the following possible side effects:

* Breast cancer
* Cancer of the uterus
* Stroke
* Heart attack
* Blood clots
* Dementia
* Gallbladder disease
* Ovarian cancer
* High blood pressure
* Liver problems
* High blood sugar
* Enlargement of benign tumors of the uterus ("fibroids")

These are only some of the possible side effects of prescription drugs. Unfortunately, there are many more.

What do you think? Want some?

Diseases and Conditions

MRSA - Rapid Blood Test

On January 28, 2008, the U.S. Food and Drug Administration (FDA) announced its approval to begin marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus). MRSA is a dangerous mutant strain of bacterium resistant to methicillin, an antibiotic that has previously been used successfully to treat Staphylococcus aureus infections. MRSA can cause potentially life-threatening infections to your blood stream... surgical site infections... even pneumonia, and has an even higher fatality rate! MRSA has long been a problem in the health care setting, but it is increasingly a community problem as well.

The test, known as the BD GeneOhm StaphSR Assay, can differentiate the methicillin-resistant variant from the methicillin-susceptible variant in two hours, rather than the 24 to 48 hours or longer that currently available technology takes. Distinguishing between the two sources of infection is critical to successful treatment. Studies leading to the test's approval found that it could identify 100% of MRSA samples and 98% of the susceptible types. According to an FDA statement, this test should be used in patients already suspected of having a staph infection but not to monitor treatment or initially detect it.

"This test is good news for the public health community," said Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health. This test previously was given FDA approval to identify colonized patients. The product's manufacturer, BD (Becton, Dickinson and Co.), is pursuing U.S. approvals for it to be used for nasal swabbing and the detection of MRSA in wounds.

Doctors still might have to conduct follow-up testing to pin down precisely what will kill particular bacteria, but physicians say the information provided by this product will be enough to narrow down treatment choices early on. According to Ed Septimus, MD, an infectious disease physician in Houston and a board member of the Infectious Diseases Society of America, "Compared to what we have now, this is terrific. We will be able to get appropriate treatment to the patient much faster, and we will be able to intervene at a much earlier time so transmission does not occur." Initially, this test most likely will be used on the sickest, hospitalized patients.

Although there is a lot of hope for the test's potential, there are also concerns. Experts, for instance, expect there may be a lag between this test becoming available and doctors becoming comfortable enough with it to use it for decision-making. "Having more tools is good, but there's going to be a certain learning curve," said Thomas Fekete, MD, professor of medicine and an infectious disease specialist at Temple University in Philadelphia. "And I don't know if laboratories will be financially prepared to take on this new technology. I'm not saying it's not worth it, but there's a price to pay."

Experts say getting a better handle on MRSA is key, because evidence is accumulating that it may be far more common than previously thought. A study in the December 2007 American Journal of Infection Control found that nationally, 46.3 per 1,000 in-patients carried the bacteria. Of these, at least 34 were infected and 12 were colonized. The remainder of cases were unclassified. Approximately 70% of cases appear to have been contracted in the health care setting. The authors suspect that the true numbers may be much higher. Only 29% of institutions surveyed actively hunted for these bacteria, and most did not use highly sensitive means to do it.

"This is the minimum estimate, because the majority are not doing screening and [are] testing by less sensitive methods. It's a much bigger problem than anyone had predicted," said William Jarvis, MD, lead author on that paper and a consultant with Jason & Jarvis Associates, a private firm that provides expertise on public health, infection control and patient safety. Other papers have documented MRSA's impact. One of the most recent, in the Oct. 17 2007, Journal of the American Medical Association, estimated that there were 94,360 cases of invasive MRSA infections and 18,650 deaths in 2005. Patients older than 65 were particularly vulnerable.

For those not wanting to take chances on uncertain, delayed treatment, it's good to know that there is a completely 100% natural product that can not only KILL MRSA, but may also prevent the potentially life-threatening infection from harming you. Prevention of infectious diseases is far more preferable than any treatment, even a successful one.


Natural MRSA Fighter

New and Improved CPR

"You know you're doing it right when you hear the ribs crack." Those words -- spoken by a paramedic teaching me how to do CPR -- have always stuck with me. They made sense at the time: In order for traditional CPR to work, the rescuer needs to compress the victim's sternum by at least an inch-and-a-half to two inches, over and over again -- and doing that can definitely result in a cracked rib or two.

But a new CPR technique, devised by Leslie Geddes, PhD, DSc, Showalter Distinguished Professor Emeritus at Purdue University's Weldon School of Biomedical Engineering, does away with both cracked ribs and mouth to mouth resuscitation (a concern due to the risk of infection), while also pumping 40% more oxygen-rich blood through the heart. Since conventional CPR has a success rate of just 5% to 10%, Dr. Geddes was looking for a better form of CPR that would improve blood flow and be easier for one person to perform. The technique, known as "Only Abdominal Compression" or OAC-CPR, works by pushing rhythmically on the abdomen (above the belly button), instead of the chest, to squeeze blood through the circulatory system. At the same time, the compression forces the diaphragm to move rhythmically so that air flows into and out of the lungs. In the preliminary tests on pigs Dr. Geddes and his colleagues have done thus far, there's no apparent increased risk of injury to internal organs using OAC-CPR or any increase in the victim's risk of vomiting.

NOT YET OFFICIAL

Dr. Geddes has great hopes that this new form of CPR will gain popularity and save lives -- though he says it will take time before it becomes official. Research is underway to learn more about risks and benefits, and a device Dr. Geddes and his team developed to make the procedure easier needs to be reviewed by the government before it can be recommended for use on people. We'll keep you posted.


Source(s):

Leslie Geddes, PhD, DSc, Showalter Distinguished Professor Emeritus, Weldon School of Biomedical Engineering, Purdue University.


Vital Wellness

Banana - Wonder food

Bananas: Containing three natural sugars - sucrose, fructose and
glucose combined with fiber, a banana gives an instant, sustained and
substantial boost of energy. Research has proven that just two bananas
provide enough energy for a strenuous 90-minute workout. No wonder the
banana is the number one fruit with the world's leading athletes. But energy
isn't the only way a banana can help us keep fit. It can also help
overcome or prevent a substantial number of illnesses and conditions,
making it a must to add to our daily diet.

Depression: According to a recent survey undertaken by MIND amongst
people suffering from depression, many felt much better after eating a
banana. This is because bananas contain tryptophan, a type of protein
that the body converts into serotonin, known to make you relax, improve
your mood and generally make you feel happier.

PMS: Forget the pills -- eat a banana. The vitamin B6 it contains
regulates blood glucose levels, which can affect your mood.

Anemia: High in iron, bananas can stimulate the production of
hemoglobin in the blood and so helps in cases of anemia.

Blood Pressure: This unique tropical fruit is extremely high in
potassium yet low in salt, making it the perfect way to beat blood pressure.
So much so, the US Food and Drug Administration has just allowed the
banana industry to make official claims for the fruit's ability to reduce
the risk of blood pressure and stroke.

Brain Power: 200 students at a Twickenham (Middlesex) school were
helped through their exams this year by eating bananas at breakfast,
break, and lunch in a bid to boost their brain power. Research has shown
that the potassium-packed fruit can assist learning by making pupils more
alert.

Constipation: High in fiber, including bananas in the diet can help
restore normal bowel action, helping to overcome the problem without
resorting to laxatives.

Hangovers: One of the quickest ways of curing a hangover is to make a
banana milkshake, sweetened with honey. The banana calms the stomach
and, with the help of the honey, builds up depleted blood sugar levels,
while the milk soothes and re-hydrates your system.

Heartburn: Bananas have a natural antacid effect in the body, so if
you suffer from heartburn, try eating a banana for soothing relief.
Morning Sickness: Snacking on bananas between meals helps to keep
blood sugar levels up and avoid morning sickness.

Mosquito bites: Before reaching for the insect bite cream, try
rubbing the affected area with the inside of a banana skin. Many people find
it amazingly successful at reducing swelling and irritation.
Nerves: Bananas are high in B vitamins that help calm the nervous
system.

Overweight and at work? Studies at the Institute of Psychology in
Austria found pressure at work leads to gorging on comfort food like
chocolate and crisps. Looking at 5,000 hospital patients, researchers found
the most obese were more likely to be in high-pressure jobs. The report
concluded that, to avoid panic-induced food cravings, we need to
control our blood sugar levels by snacking on high carbohydrate foods every
two hours to keep levels steady.

Ulcers: The banana is used as the dietary food against intestinal
disorders because of its soft texture and smoothness. It is the only raw
fruit that can be eaten without distress in over-chronicler cases. It
also neutralizes over-acidity and reduces irritation by coating the
lining of the stomach.

Temperature control: Many other cultures see bananas as a "cooling"
fruit that can lower both the physical and emotional temperature of
expectant mothers. In Thailand, for example, pregnant women eat bananas to
ensure their baby is born with a cool temperature.

Seasonal Affective Disorder (SAD): Bananas can help SAD sufferers
because they contain the natural mood enhancer tryptophan.

Smoking: Bananas can also help people trying to give up smoking. The
B6, B12 they contain, as well as the potassium and magnesium found in
them, help the body recover from the effects of nicotine withdrawal.

Stress: Potassium is a vital mineral, which helps normalize the
heartbeat, sends oxygen to the brain and regulates your body's water
balance. When we are stressed, our metabolic rate rises, thereby reducing our
potassium levels. These can be rebalanced with the help of a
high-potassium banana snack.

Strokes: According to research in "The New England Journal of
Medicine, "eating bananas as part of a regular diet can cut the risk of death
by strokes by as much as 40%!

So, a banana really is a natural remedy for many ills. When you
compare it to an apple, it has four times the protein, twice the
carbohydrates, three times the phosphorus, five times the vitamin A and iron,
and twice the other vitamins and minerals. It is also rich in potassium and
is one of the best value foods around. So maybe its time to change that
well-known phrase so that we say, "A banana a day keeps the doctor
away!"



Superfood Concentrate