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.

Six New Studies Confirm Health Dangers of Plastic

Six New Studies Confirm Health Dangers of Plastic
by www.SixWise.com


The most up-to-date research shows that exposure to chemicals released from various plastic products and flame-retardant materials cause "adverse health effects in humans and laboratory animals." An entire section of the October 2008 issue of Environmental Research, "A Plastic World," was devoted to the results of a series of six environmental research studies.

Chemicals in plastic products

Chemicals in plastic products you likely use everyday have been definitively linked to serious health problems including brain and reproductive damage and cancer.

These research studies investigated the health effects of chemicals such as bisphenol A (BPA), polyvinyl chlorate (PVC), phthalates, and polybrominated diphenylether (PBDE). Results showed that plastics contain "endocrine disrupting chemicals" that can interfere with the thyroid hormone, block the production of testosterone, and mimic the action of estrogen in your body.

These studies specified that fetal exposure to phthalates caused changes in male reproductive organs of humans and rats. Fetal exposure of rats and mice to BPAs and PBDEs showed a disruption in normal brain development and behavior. Research also provided evidence to show that great harm is being done to aquatic wildlife because our oceans are being polluted by enormous amounts of these plastic-related chemicals.

"For the first time a series of articles will appear together that identify that billions of kilograms of a number of chemicals used in the manufacture of different types of plastic can leach out of plastic products and cause harm to the brain and reproductive system when exposure occurs during fetal life or prior to weaning," according to Dr. Frederick vom Saal, guest editor of the "Plastic World."

PVC, a highly toxic chemical found in shower curtains

PVC, a highly toxic chemical found in shower curtains, plastic piping, toys and building supplies, is not something you want in your home, particularly if you have small children or are pregnant.

This most recent research reported that prenatal exposure to rats, and exposure around the time of gestation to even small amounts of BPA led to abnormalities in the development of mammary tissue, which led to an increase in pre-cancerous lesions and mammary tumors. Adult exposure to BPA led to an increase in mammary tumors as well.

BPA mimics estrogen in the body. As a result of this, research involving cultures of human breast cancer cells showed that BPA causes changes in cell growth and proliferation as well as damage to cellular DNA -- potential precursors to cancer.

Some Facts About These Toxic Chemicals

* BPA
o Highly toxic
o Used to make many plastic consumer products
o Toxins released over time and when heating liquids in plastic containers
o

Found in plastic water bottles, drinking glasses, food containers, baby bottles, lacquer lining of metal food cans, microwave ovenware, plastic utensils, etc.
* PVC (polyvinyl chlorate)
o Highly toxic
o Found in many toys, building supplies, plastic piping, shower curtains, various soft plastic products, etc

* Phthalates
o Mimics the effects of estrogen in the body
o Causes skin irritations
o Found in many cosmetics and shampoos, PVC products (i.e. toys), etc.

* PBDEs (polybrominated diphenylether)
o Highly toxic
o Found in flame-retardant materials, furniture foam, back coatings for draperies and upholsteries, electronics, small appliances, etc.


Protecting Yourself From Plastic

The safest way to prevent adverse health effects from these chemicals is to avoid exposure to the plastics and products that contain them.

* Use glass and paper products instead of plastic.
* Avoid drinking bottled water.
* Replace toxic plastic products with safer plastics, such as bio-based materials.
* Be aware that a "3" or a "V" stamped underneath the recycling symbol of your plastic product indicates that the product contains PVC.
* Smell your plastic! PVC products give off a distinct odor from toxic gases being released, such as the smell from a vinyl shower curtain.
* During the construction process -- when building a house, for instance -- make sure to avoid installing PVC plastic piping.

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.”

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