FDA Looking into Triclosan?

UPDATE: 8/29/10  Triclosan and antibacterial warnings -
Updates at Natural Healing through Natural Health -

New article here from Jill Richardson, compiling much of what we have been teaching about the risk of triclosan since the late 80s.

from Natural Health News...

Natural Health News: FDA Looking into Triclosan?

Apr 09, 2010

In a claim filed Tuesday, the National Resources Defense Council says the FDA didn't regulate the levels of triclosan and triclocarban in the soap, two toxic chemicals that can cause problems with reproductive organs, sperm quality and ...

Chloroform Danger With Antimicrobial Soap

Apr 16, 2005

The main reason for my advice has been that these chemicals, such as triclosan, disturb the balance of naturally occurring staph bacteria on the skin's surface (epidermis). Now here is more convincing evidence. ...

Hand Sanitizers: UPDATE

Nov 01, 2009

If the product contains Triclosan, also be cautious: Researchers who added triclosan to water and exposed it to ultra-violet light found that a significant portion of the triclosan was converted to dioxin. Triclosan reacts with chlorine ...

Another "Green Living"© writer warns of hand sanitizers

May 26, 2008

But I did already know that certain hand purifying gels contained, among other undesirables, the hormone disrupting antibacterial/antifungal agent triclosan, which can form dioxins when it comes into contact with water and has some

Natural Health News: MRSA - Alternative Cure For 'Flesh-Eating ...

Dec 26, 2009

These contain Triclosan and will kill off naturally occurring bacteria on your skin that serves to protect you from infection. Many non-effective anti-biotics are on the market today and some of these have very serious side effects.

UPDATE: 8/21/10 - Two Dangerous Ingredients in Everyday Products That Are Threatening Our Health

Triclosan and triclocarban are widely used in antibacterial soaps, body washes, deodorants, lip glosses, dog shampoos, shave gels and even toothpastes. Read more...

UPDATE: 7/30/10 -

Health Group Sues FDA Over 'Dangerous' Antibacterial Soap

The U.S. Food and Drug Administration is being sued by a nonprofit environmental group for what the members claim is dangerous “antimicrobial” soap, Reuters reports.
In a claim filed Tuesday, the National Resources Defense Council says the FDA didn’t regulate the levels of triclosan and triclocarban in the soap, two toxic chemicals that can cause problems with reproductive organs, sperm quality and the production of thyroid and sex hormones.
Kathleen Sebelius, U.S. Department of Health and Human Services Secretary, is named as a defendant in the suit, but no specific manufacturers or retailers were mentioned, according to Reuters.
The nonprofit claims it first approached the FDA about regulating this soap and other personal care products for over-the-counter use more than 30 years ago, but no action has been taken.
According to the lawsuit, the FDA proposed a ban from interstate trading of both chemicals in 1978 but nothing changed until 1994 when some ingredients were reclassified, Reuters reports.
The FDA said in April that the ingredient triclosan has not been shown to be harmful
to humans and that further study is needed.
The plaintiffs are requesting the FDA be given a deadline to complete its study on the conditions for using these products.

--------------------------------------------------------------------------------------------------------------------------
posted April 2010: It never ceases to amaze me just how slow out US government agencies are slow to act to protect the citizenry. And they won't comment until sometime in 2011. Maybe an addendum to the health bill should require that the FDA clean up its political quagmires.

I've been warning about triclosan for at least 15 years, based on the science and at least the MSDS data.

What is so bad about triclosan is that is destroys what is referred to as the protective "acid mantle" of the skin, and creates a breeding ground for infection because it destroys the healthy bacteria on your skin:the healthy bacteria that is there to protect you from infection.

This is one time it pays to read labels and another to look to the use of natural castile soaps without fragrance and using truly health promoting skin lubrication like you can get from my colleague at Kettle Care.

FDA Warns of Risk in Antibacterial Additive
By Cole Petrochko, Staff Writer, MedPage Today
Published: April 08, 2010


WASHINGTON -- The FDA has notified consumers that the antibacterial agent triclosan's safety data is being reviewed due to concerns raised in lab tests on animals.
Research from the Environmental Protection Agency's Office of Research and Development found triclosan had thyroid and estrogen effects in animals.
The agent is a common ingredient in antibacterial soaps and washes, toothpastes, and cosmetics, all of which are regulated by the FDA.
The ingredient's profile was raised in January when Rep. Edward J. Markey (D-Mass.), chairman of the House Energy and Commerce Subcommittee on Energy and Environment, wrote the FDA to ask about a review of triclosan's use in consumer products.
Additional investigation was deemed necessary after animal studies showed potential negative effects of the ingredient, the FDA said in a prepared statement. Though studies are ongoing, the FDA does not currently have enough evidence to suggest a change to any consumer products with triclosan.
The FDA noted that although triclosan provided a clear benefit in some consumer products, the extra health benefit it offered in others was not as apparent.
The agency advised consumers that the ingredient poses no apparent danger to humans, but that soaps and body washes with triclosan may not provide additional health benefits over soaps without the additive; consumers concerned about its potential health hazards should switch to regular soaps without triclosan.
The FDA announced it will work with other federal agencies, including the Environmental Protection Agency, to study the effects of triclosan on humans, animals, and the environment.
The agency said it planned to publish its findings in spring 2011.

Chloroform Danger With Antimicrobial Soap, a 2005 post from Natural Health News

Hand Sanitizers: UPDATE

Nov 01, 2009

If the product contains Triclosan, also be cautious: Researchers who added triclosan to water and exposed it to ultra-violet light found that a significant portion of the triclosan was converted to dioxin. Triclosan reacts with chlorine ...

Another "Green Living"© writer warns of hand sanitizers

May 26, 2008

But I did already know that certain hand purifying gels contained, among other undesirables, the hormone disrupting antibacterial/antifungal agent triclosan, which can form dioxins when it comes into contact with water and has some ...

Natural Health News: MRSA - Alternative Cure For 'Flesh-Eating ...

Dec 26, 2009

These contain Triclosan and will kill off naturally occurring bacteria on your skin that serves to protect you from infection. Many non-effective anti-biotics are on the market today and some of these have very serious side effects. ...

Common Sense Needed, not new risky weight loss drug

Obesity Concerns Not Cured by A Risky Drug: FDA Plans to Review First of 3 New Diet Drugs

Remember Phen-Fen, an older alleged weight loss drug that harmed the hearts of many and often caused pulmonary hypertension among its other gifts?

It may be reappearing in a different form, a new concoction of phentermine and topiramate, ready to be reviewed by our trusting folks at the FDA.

Phen-Fen: The once-popular diet-drug combination of fenfluramine and phentermine that, amidst much media attention, was taken off the market because of concern for heart valve damage.

Fenfluramine hydrochloride is an anorectic drug for oral administration. Immediate release tablets containing 20 mg fenfluramine hydrochloride are orange, scored, compressed tablets engraved AHR and 6447.
Inactive Ingredients: Corn Starch, FD&C Yellow 6, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sodium Lauryl Sulfate.

Fenfluramine HCl - one of many fluoride based drugs - has the following chemical name: N-ethyl-alpha-methyl-3-(trifluoromethyl) benzeneethanamine hydrochloride.

The most common adverse reactions of fenfluramine are drowsiness, diarrhea, and dry mouth. Less frequent adverse reactions reported in association with fenfluramine are:

Central nervous system: Dizziness; confusion; incoordination; headache; elevated mood; depression; anxiety, nervousness, or tension; insomnia; weakness or fatigue; increased or decreased libido; agitation, dysarthria. Gastrointestinal: Constipation; abdominal pain; nausea. Autonomic: Sweating; chills; blurred vision. Genitourinary: Dysuria; urinary frequency. Cardiovascular: Palpitation; hypotension; hypertension; fainting; pulmonary hypertension. Skin: Rash; urticaria; burning sensation. Miscellaneous: Eye irritation; myalgia; fever; chest pain; bad taste.

Drug Abuse and Dependence

Fenfluramine hydrochloride is a controlled substance in Schedule IV. Fenfluramine is related chemically to the amphetamines, although it differs somewhat pharmacologically.

Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethyl sulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solu tion has a pH of 6.3. Topiramate has the molecular formula C₁₂H₂₁NO₈S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: used for Seizure and Migraine

14 July, 2010  NEW YORK (AP) – Vivus Inc.'s potential weight loss drug Qnexa will likely draw scrutiny over nervous system and psychiatric side effects from a panel of Food and Drug Administration experts this week.
But shares jumped in morning trading as the FDA acknowledged the potential blockbuster drug's effectiveness in cutting weight. The stock rose $1.75, or 16 percent, to $12.40 in morning trading, more than doubling from a low of $5.57 last July.
The FDA raised some concerns in briefing documents posted online on Tuesday about a range of side effects. It said reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others. The concerns were not a surprise to Wall Street, which has been following development of the drug over the last several years. Complete article

Side effects include but may not be limited to

Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.

Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Allergic: Urticaria.
Endocrine: Impotence, changes in libido.

http://www.diet.com/g/fenphen

Sensible responses to weight issues are welcome.

Our main organization, CHI, offers nutritional and spiritual counseling 

 

If the 'Phen' proportion isn't bad enough consider the anti-seizure drug's problems. Just check out page three of this drug information database and evaluate for yourself.

http://www.rxlist.com/topamax-drug.htm

http://www.vivus.com/pipeline/qnexa-obesity

http://www.merck.com/mmpe/lexicomp/topiramate.html

http://www.aolhealth.com/2010/07/12/fda-plans-to-review-first-of-3-new-diet-drugs/

http://www.thatsfit.com/2010/07/12/obesity-was-no-laughing-matter-for-comedian-sonya-d/

PhRMA GREED leads to statins for children

Statins for children 10 to 17 have been FDA approved since 2002.  Now Pfizer seeks EU authorization. 

READ IT HERE FIRST: THE IMPORTANT ISSUES FACING YOU IN HEALTH CARE AT NATURAL HEALTH NEWS DAYS, AND OFTEN WEEKS OR MONTHS, AHEAD OF THE SITES THAT HAVE BEEN COPYING OUR WORK FOR MORE THAN 10 YEARS...

Liptor and other statin drugs already have a record of serious side effects and other problesm related to increased risk of demthia and cancer as well as liver and kidney failure.

At what price do those on the take at FDA, and in Congress, begin to show a little ethical behavior as well as really determining the root cause of why children are becoming obese.

Pfizer gets EU approval for kids' cholesterol drug

By LINDA A. JOHNSON, AP Business Writer  Tue Jul 6,  2010

TRENTON, N.J. – The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides, a type of blood fat, Pfizer said Tuesday.
The approval includes children whose high blood fats are due to an inherited disease that causes extremely high cholesterol levels, familial hypercholesterolemia.
New York-based Pfizer Inc. won U.S. approval for Lipitor use in children 10 to 17 with that condition in 2002.
Lipitor is the world's top-selling drug, with 2009 sales of about $13 billion, but its U.S. patent expires at the end of November 2011. Pfizer, the world's biggest drugmaker, will quickly lose most Lipitor revenue once generic competition hits, so the company has been trying to boost sales where possible before then.
Pfizer said last fall that it plans to apply for a six-month extension of its patent in European countries, after doing studies of Lipitor in youngsters.
As in the United States, the European Union allows drug makers to seek an additional six months of patent protection for medications if they test them in children, who generally are excluded from the drug studies performed to win approval for a new medication.
Pfizer already won such an extension for its crucial U.S. patent on Lipitor.
For blockbuster drugs, those extensions can easily bring hundreds of millions of dollars in additional revenue. Normally, they are for drugs that are widely used by different age groups.
Until recently, cholesterol drugs have been primarily taken by adults with heart disease, but their use has expanded to younger patients as more obese, sedentary teenagers and adolescents develop heart disease and diabetes.
Lipitor is approved to lower risk of heart attack and stroke, but can cause dangerous muscle pain or weakness, and it cannot be taken by patients with liver problems or by nursing or pregnant women.

FDA takes action against LifeSoy products

FDA takes action against soy-product firm
WASHINGTON, June 7 (UPI) -- The U.S. Food and Drug Administration says a California maker of ready-to-eat soy products will stop operations until it complies with federal sanitary rules.

The FDA said Lifesoy Inc. of San Diego was accused of preparing, packing and holding articles of food under unsanitary conditions. Officials Monday said the company entered into a U.S. District Court consent decree of permanent injunction that requires the firm to stop manufacturing and distributing food products until it registers with the FDA and complies with federal laws regarding sanitary practices.

Lifesoy makes sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding and other soy products for human consumption.

The government also accused Lifesoy and its owner, Long Lai, of failing to hold and store foods under proper refrigeration conditions to prevent the growth of micro-organisms.
© 2010 United Press International, Inc. All Rights Reserved.

FDA and Avandia: Ethics Lacking

FDA-Sanctioned International Diabetes Drug Trial Is Unethical and Dangerous
“Surely no patient would willingly participate in a trial in which they have a substantial likelihood of taking a drug that, in the opinion of a large group of experts, has no role in present day therapeutics because of its risks,” Wolfe said. “The trial shouldn’t continue because the question has been answered. If the trial continues, the health of thousands of patients will be jeopardized. It is unethical to continue this trial. As unethical as it is in developed countries such as the U.S. and Canada, it is even more unconscionable to subject people in developing countries such as Chile, Mexico, Colombia, Latvia, Pakistan and India to a drug known to be more dangerous than the drugs it is being compared to.” 
Complete areticle

Opinion: The Deadly Gap in the Drug Safety Net

Opinion: The Deadly Gap in the Drug Safety Net

"Each day, about two out of every 100 prescriptions filled at pharmacies around the country are for drugs that have never -- repeat, never -- been approved by the Food and Drug Administration.

These unapproved drugs often make unsubstantiated claims not supported by scientific data or laboratory testing. Many of them are wrongly deemed safe and are often incorrectly labeled as "generics." None of them has ever seen the light of an FDA laboratory.

As a result, patients often end up taking drugs unaware that by doing so they are putting themselves at risk of a dangerous side-effect or potentially life-threatening adverse drug interaction."

Read complete article using link above

Drug Information Never Reaches Clinicians

FDA drug information that never reaches the clinician

Important information regarding the benefits and harms of FDA approved prescription drugs, does not make its way into the hands of the clinician - writes Lisa Schwartz in the New England Journal of Medicine. The FDA is the American drug regulatory body. Drug labels (package inserts) are the direct way of communicating prescribing information to physicians- but they are written by the drug companies and then negotiated or approved by the FDA. Drug approval requires that preclinical studies and the results of at least two phase 3 studies in patients - are submitted to highly qualifed FDA experts which may take a year to evaluate. The FDA produce review documents recording the reasoning behind approval. These are lengthy and can be complex - the problem seems to be that important information is getting lost - and never makes it onto a drug label. The authors report a number of possible harms - which fail to make it onto the drug labels, but also efficacy data that can be useful, but again is lost from the final drug sheets.

The FDA has recognised some problems with drug labels and in 2006 introduced a highlights section to emphasize drug warnings and indications. It has also issued guidance about reporting trial results in labels - but in at least 2 drugs studied, labels remained unimproved.

It seems that a better way of communicating information that is already known, but not passed into the clinicians hands must be expedited.

Source

WEB: http://content.nejm.org/cgi/content/full/361/18/1717

Nano-Foods, A Risk to Human Health

Part 2 now available: Regulated or Not, Nano-Foods Coming to a Store Near You

This despite the fact that hundreds of peer-reviewed studies have shown that nanoparticles pose potential risks to human health -- and, more specifically, that when ingested can cause DNA damage that can prefigure cancer and heart and brain disease.

Despite Denials, Nano-Food Is Here

Corruption at its very best

If you, like so many, beliveve that there is no conflict of interest in what the FDA does in its incestuous involvement with Big PhRMA, then all you have to do is realize the height of corruption as Julie Gerberding comes to Merck, heading up its vaccine division.

This is a very clear example of the government-corporate revolving door policy.

When we have ethics in government, this sort of thing doesn't happen for at least three years follwoing government employment.

And we all know how influential Merck has been at CDC and FDA, especially over the recent boost to its bottom line from swie flu vaccine sales, at a time when Gerberding was still with CDC.  

Dr. Julie Gerberding Named President of Merck Vaccines

WHITEHOUSE STATION, N.J. - (Business Wire) Merck & Co., Inc. (NYSE: MRK) today announced that Dr. Julie Gerberding has been named president of Merck Vaccines, effective January 25, 2010.

Dr. Gerberding led the Centers for Disease Control and Prevention (CDC) as director from 2002 to 2009. During her tenure at CDC, Dr. Gerberding led the agency during more than 40 emergency response initiatives for health crises including anthrax bioterrorism, food-borne disease outbreaks, and natural disasters, and advised governments around the world on urgent public health issues such as SARS, AIDS, and obesity.

“Vaccines are a cornerstone of Merck's commitment to health and wellness," said Richard T. Clark, chairman and chief executive officer, Merck & Co., Inc. "We are delighted to welcome an expert of Dr. Gerberding's caliber to Merck. As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck's engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives."

"I’ve had the privilege in my previous work in academia and in the federal government to be a passionate advocate for public health priorities such as vaccines, which are an imperative component of global health development," said Dr. Gerberding. "I am very excited to be joining Merck where I can help to expand access to vaccines around the world."

Read complete story: http://www.earthtimes.org/articles/printpressstory.php?news=1098689

Pfizer Pays Record Fines for Illegal Activity

WASHINGTON – Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

"They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

To prevent backsliding this time, Pfizer's conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

Complete article from AP

TV Drug Ads, Celebrities and FDA Propaganda

UPDATE: May 27, 2010 - FDA Adds Liver Injury Warning to Diet Drug

WASHINGTON -- The weight-loss medication orlistat, marketed both by prescription as Xenical (120 mg) and over-the-counter as Alli (60 mg), will carry a warning about the potential for severe liver injury, the FDA announced ... full story http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/20310

UPDATE: August 25 - FDA probes liver damage with weight loss pill alli
----------------------------------------------------------------------
Originally posted 2/13/09
As we shall see over comings months the stimulus package is not going to be all you think it is because of smoke, mirrors and an ever expanding bureaucracy.

Not too far removed from the stimulus issue is how TV ads for drugs push up profits for Big Pharma.

One example of just how thick as thieves things are between drug companies and their PR programs is a recent story about how Wyeth promoted risky HRT through a media program aimed at increasing prescription writing for their well know hormone product just as they moved to be bought out by Pfizer.

Now, as if this $12 million isn't enough of a tax write off for the drug industry, GSK is leading us all down the pike to fairy land with its ad featuring Wynonna for its over-the-counter weight loss drug 'alli'.

During the commercial featuring Wynonna, whom we all know has had some serious weight problems, is shown serving herself some vegetables during a family meal. Then the camera moves to a tight head shot where we learn that she could not erccomend anything that sin't safe but she is gald that alli is FDA approved.

These days FDA approval and a quarter don't get you a cup of coffee.

And here is probably a fairly reliable take on what the glossy ad that cost plenty of money alone, not including air time fees, might be what GSK doesn't want you to know.

Alli Weight Loss Pill: Expectations Vs. Reality
January 02, 2008 by Big Momma
It's the time of year when our thoughts focus on shedding a few pounds. We are inundated with commercial advertisements promoting the best, easiest or fastest way to lose weight.

Alli is the newest over the counter weight loss pill that promises hope to the masses by blocking fat absorption in the body. Alli is FDA approved, is not absorbed into your body and works only in the digestive track.

My first red flag regarding Alli was the product statement that Alli is to be used together with a reduced calorie diet to promote weight loss. A reduced calorie diet by itself will promote weight loss, but let's see the results that one Alli user has had.

An acquaintance of mine has been using Alli for several months, her expectations from the Alli pills were to help her jump start a weight loss program that she could stick with and ultimately help her reach her goal weight.

The Alli usage pamphlet warns users of 'treatment effects', which include greasy/oily leakage in undergarments, gas with discharge, change in stool color and/or fatty deposits in stools, inability to control bowel movements, stomach pain, rectal pain, teeth/gum problems or flu like symptoms. Alli users are advised to wear dark clothing and pads to protect against the leakage.

This is the reality she got from using Alli: Large amounts of uncontrollable leakage of a greasy substance that permanently stained her clothing. Dark clothing and pads could not contain or hide the leakage most of the time. She had a significant increase in gas and odor, with gas bubbles being expelled along with the greasy substance. She had no control over this.

Abdominal cramping became a part of her daily life, she likened the feeling to a gall stone attack. She felt tired all the time, even though she was taking the additional vitamins that are recommended by Alli. She also experienced hair loss while taking Alli.

After using Alli for six months, she had lost a total of 15 pounds. Yes, 15 pounds.

Another 'treatment effect' of Alli is that even after you stop taking it, you experience the greasy leakage and abdominal pains for up to two months, until the product works it's way completely out ofyour system.

A new wardrobe is eagerly anticipated at the end of a diet, but having to buy new clothing during the diet due to your body leaking grease, is altogether different.

Six months and 15 pounds later, the expectations from the weight loss pill Alli and the reality of it did not even come close.

NB: Natural Health News posted this information in 2008.  It took Mike Adams another 2 years to inform you, yet his backers are continually continually monitoring this website, now for 6 years, to get their story ideas. 1 June,10.

US agencies challenge natural products

US agencies challenge natural products in advance of vaccination program

ANH joins the dots over FDA and FTC restrictions on natural products prior to vaccine roll-out
http://www.anhcampaign.org/news/us-agencies-challenge-natural-products-in-advance-of-vaccination-program

A cancerous conspiracy to poison your faith in organic food

The Benefits of Zinc

UPDATE: 6/4/10 - Zinc Reduces Oxidative Stress

An article published in the June, 2010 issue of the American Journal of Clinical Nutrition describes a clinical trial involving older men and women which found reductions in markers of oxidative stress and inflammation among those who supplemented with zinc. Oxidative stress and chronic inflammation are risk factors for atherosclerosis, and zinc deficiency has been observed in a number of other diseases associated with these conditions, including rheumatoid arthritis, diabetes and cancers. "We previously observed that healthy elderly subjects had increased concentrations of plasma lipid peroxidation byproducts and endothelial cell adhesion molecules compared with concentrations in younger adults," the authors write in their introduction. "Zinc was proposed to have an atheroprotective function because of its antiinflammatory, antioxidant, and other properties."

In a double-blinded trial, 40 healthy men and women between the ages of 56 and 83 were randomized to receive 45 milligrams zinc from zinc gluconate or a placebo for 6 months. C-reactive protein (CRP), interleukin-6 and other markers of inflammation were measured before and after treatment, as were malondialdehyde and hydroxyalkenals, which are markers of lipid peroxidation.

Zinc concentrations were higher in the zinc group by the end of the study, while remaining relatively unchanged among those who received the placebo. Plasma antioxidant powers were higher, and malondialdehyde and hydroxyalkenals were lower in the zinc supplemented subjects after 6 months, indicating a reduction in lipid peroxidation. Additionally, plasma C-reactive protein, interleukin-6, and other inflammation-associated factors were reduced among those who received zinc. “To our knowledge, this is the first documentation to show the down-regulation of plasma CRP concentrations by zinc supplementation in human subjects,” the authors remark.

In another experiment involving cell cultures, zinc also reduced indicators of inflammation and lipid peroxidation as well as the activation of nuclear transcription factor kappa-beta, which is involved in the initiation and development of atherosclerosis.

"This study showed that zinc increased antioxidant power and decreased CRP, inflammatory cytokines, adhesion molecules, and oxidative stress markers in elderly subjects after 6 months of supplementation," the authors write. “These findings suggest that zinc may have a protective effect in atherosclerosis because of its antiinflammatory and antioxidant functions,” they conclude.

ORIGINALLY POSTED: 06/09
Zinc is an important mineral for immune health. It is however one that is hard to absorb. Because of this issue we always suggest to use a low dose, food-based compound, taking several daily.

On the other hand, too much zinc can suppress your immune system so we do suggest not taking more than 50-60 mg a day.

Zinc is helpful for people with diabetes and any hormonal imbalance (think endocrine system and glands). It is good for teens with acne and is the generally considered to be the key nutrient for prostate health. Additionally, loss of taste is related to zinc deficiency.

While some people may have developed some sort of a problem with Zicam, a 2X dilution of a substance in a homeopathic remedy is not a very high dose.

What concerns me more is the total avoidance by the FDA of the issue of common steroid and fluoride-containing nose sprays and the over-prescribing of antibiotics and antihistamine drugs that lead to more serious problems, including loss of function of the natural body protective mechanism that causes the mucous membrane lining of the nose (and respiratory system) to secrete more mucus in order to keep invading irritants and allergens out of the body. These drugs also have been known to interfere with the function of nasal hairs as part of this process.

So, FDA, how about blocking all these Rx drugs while you're blocking Zicam? Your Big Pharma bias is just too prevalent.

And if you'd like to know more about natural ways to take care of your cold or allergy, you can find more information at our main domain. Add a little vitamin C and vitamin A to the mix and you'll always come out ahead.

If you need clinical information please refer to our ASK program.

FDA: Zicam nasal spray can cause loss of smell
WASHINGTON (AP) — Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives' Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

"Loss of the sense of smell is potentially life threatening and may be permanent," said Dr. Charles Lee, of FDA's compliance division. "People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house."

Matrixx defended the safety of its products, but said late Tuesday it will withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market.

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.

A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

"The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval," said Deborah Autor, director of FDA's drug compliance division.

The agency is requiring formal approval now because of the product's safety issues, she added.

"It won't bring my smell back, but at least I feel like there's some justice that's starting to take place," said David Richardson, of Greensboro, N.C., who lost his sense of smell after taking Zicam for a cold in 2005. He said he hopes the product will be formally banned.

Medical records appear to support Richardson's claim that his lost sense of smell was linked to using Zicam.

The global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. The group's members include companies like Nutraceutical International Corp. and Natural Health Supply.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its website: "No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell."

The company said in a statement Tuesday that the safety of Zicam Cold Remedy is "supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists." Matrixx said it will comply with the FDA's requirements, but will seek a meeting with the agency to "vigorously defend its scientific data."

But government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including "sore throat, stuffy nose, sneezing, coughing and congestion."

The products accounted for about 40% of Matrixx's $111.6 million in sales last year.

Health officials said they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.

Regulators said the relatively small number of complaints accounted for the agency's lengthy investigation.

"FDA doesn't take action against drug products without evaluating all of the circumstances surrounding the issues with the product," Lee said.

Shares of Matrixx Initiatives Inc. plummeted $13.46, or 70%, to $5.78 Tuesday. The company said based on the FDA's recommendation, consumers should discard any unused product or contact Zicam at 1-877-942-2626 or www.zicam.com to request a refund.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Find this article at:
http://www.usatoday.com/news/health/2009-06-16-fda-cold-medicine_N.htm?POE=click-refer

Transparency at the FDA?

from Jon Benninger's BLOG

FDA introduces "Transparency Blog" to gather public input online

The FDA has introduced what it is calling the "FDA Transparency Blog" in an effort to improve its communication with the public. The blog went live on June 2 and will include a different question each week. The questions to be posed can be found in the FDA's June 3 Federal Register notice (click here). There is also a public meeting on the topic of FDA transparency set for June 24 in Washington. Information about attending (it's free) and speaking is available in the Federal Register notice. Topics such as "Freedom of Information Act" requests, and access to information about enforcement activities, product approvals, recalls and other agency actions are specifically mentioned in the notice as areas of focus.

Black Box Avastin now gets FDA nod for brain treatment

Some of the many articles about Avastin here at NHN, back to 2006 and earlier -
http://naturalhealthnews.blogspot.com/2008/11/black-box-for-avastin.html
http://naturalhealthnews.blogspot.com/2008/11/using-more-drugs-not-less-for-cancer.html
http://naturalhealthnews.blogspot.com/2008/05/brain-cancer.html
http://naturalhealthnews.blogspot.com/2008/03/bad-decision-on-avastin.html
http://naturalhealthnews.blogspot.com/2007/12/dr.html
http://naturalhealthnews.blogspot.com/2006/09/drug-gets-new-warnings.html
http://naturalhealthnews.blogspot.com/2006/07/drugs-generator.html

Please reaview them and then follow with the FDA's latest action

Avastin approved for brain cancer therapy

WASHINGTON, May 11 (UPI) -- The U.S. Food and Drug Administration has approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme -- a form of brain cancer.

"GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities," the FDA said. "It affects about 6,700 persons in the United States every year."

Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns, the agency said.

"This type of cancer is very resistant to therapy and thus challenging to treat," said Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. "Avastin provides a therapy for patients with progressive GBM who have not responded to other medications."

The FDA first approved Avastin in 2004 to treat metastatic cancer of the colon or rectum and it since has been approved for treatment of non-squamous, non-small cell lung cancer and metastatic breast cancer.

Avastin is manufactured by Genentech Inc. (NYSE:DNA) of San Francisco.

Food Safety: More Progress Needed

Here's another reason to consider vitamins: Vitamin C helps effectively treat food poisoning.

But at the front end we do need less factory farming with methods that promote herbicides, pesticides and higher health risks from salmonella and E.coli.

While we do need to buy local to reduce health risks in the food chain, we are at a time when the government - one that hasn't been able to get past pressure from Big Pharma and Big Ag - wants to interfere with home gardening. ( Just an observation but it did not seem to me to be gardening when Mrs. Obama planted potted herbs and vegetables at the White House. These plants had to come from a nursery or retail store and seems to be little more than a photo op. What happened to organic seeds, the real way to grow a garden?)

One thing you can do is think about how you clean the food you buy. This might make you want to get a copy of our food cleansing Healthy Handout, yours with a donation.

U.S. making little progress on food safety
By Julie Steenhuysen Thu Apr 9, 2009

CHICAGO (Reuters) – Efforts to improve food safety in the United States have "plateaued," exposing the need for an overhaul of the nation's food safety system, government health officials said on Thursday.

Despite work to improve food safety in recent years, the number of foodborne infections remained steady, with little change in the past few years, suggesting fundamental problems are not being solved.

"Progress has plateaued. This indicates to us that further measures are needed to prevent more foodborne illness," Dr. Robert Tauxe of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing.

Overall, CDC identified 18,499 laboratory-confirmed cases of food poisoning in 2008 using FoodNet, a tracking system that looks at foodborne illness in 10 states, covering about 46 million people or 15 percent of the U.S. population.

"When we compared the year 2008 information with the three previous years -- 2005 to 2007 -- we see no significant change in the incidence of these infections," he said, noting that 2004 was the last year gains had been made at curbing infection rates.

Salmonella infections were the most commonly diagnosed and reported foodborne illnesses in 2008, and their numbers were essentially unchanged compared with data from 2005-2007.

The 2008 findings represent just a portion of the Salmonella Typhimurium infections caused by tainted peanuts and peanut products processed by the now bankrupt Peanut Corp of America, which has led to the biggest food recall in U.S. history.

The outbreak, which began in September, forced the recall of more than 3,200 products and sickened more than 680 people in 46 states, perhaps killing nine. A series of other incidents involving pistachios, lettuce, peppers and spinach have eroded public confidence in food safety and renewed calls for change.

NEW APPROACH

Dr. David Acheson, associate commissioner for foods at the U.S. Food and Drug Administration said the report "underscores the need for a change in approach."

"This change needs to address the safety problems around foods and really focus on how to prevent these problems in the first place," Acheson told reporters on the call.

He said the FDA was embarking on "an aggressive and proactive approach" aimed at protecting and enforcing the safety of the food supply.

"Clearly we are working very closely with the new administration and Congress on addressing these issues."

Acheson said FDA has expanded its presence overseas and now has offices in China, Latin America, Europe and India, and plans to add more scientists, investigators and inspectors to help ensure food safety in the United States.

And he said FDA has set up rapid response teams in six states to help the agency react more quickly when and outbreak occurs, with plans to add more.

"I think it has become clear preventive controls are critical," he said.

The CDC estimates that each year 76 million Americans get food poisoning, more than 300,000 are sick enough to be hospitalized and 5,000 die.

(Editing by Maggie Fox and Jackie Frank)Copyright © 2009 Reuters Limited.

Senator Ortiz y Pino Continues Fight to Ban Aspartame

Please support this important FDA action. And hopefully, this time around, Ajinmoto will not send big checks - like the 10K Bill Richardson accepted - to interfere with fact and the people's will.

New Mexico Senate
Santa Fe, New Mexico
February 12, 2009

The Honorable Frank Torti, M.D.
Acting Commissioner, United States Food and Drug Administration
5400 Fishers Lane
Rockville, Maryland

Dear Dr. Torti:

I am the New Mexico sponsor of the enclosed Senate Memorial 9, 2009, asking the Food and Drug Administration to rescind its approval for the artificial sweetener, aspartame.

You may know that the FDA, to its credit, turned down G.D. Searles application for aspartame's approval from 1966 to 1981, at which point, approval was forced through the FDA at the insistence fo Searles CEO, Donald Rumsfeld.

Numerous physicians petitions as well as many private petitions have been filed with FDA since 1981 asking for the rescinding of aspartames approval. These have all been routinely ignored and responded to with industry assurance about how many industry financed "tests" aspartame has been through, all of which showed "aspartame to be safe."

FDA used to keep records on consumer complaints on aspartame, accruing a minimum of 92 alleged symptoms from ingesting aspartame, ranging from headaches, blurred vision, skin rashes, epilepsy and multiple sclerosis to that ultimate symptom, DEATH.

Dr. Torti, this chemical has produced a massive mountain of medical and neurodengenerative evidence, which I believe would lead you to order it removed from the market. While it is too late to do this now as a "precaution"; it is even more imperative to do this as a means of preventing further medical harm to future victims.

This Memorial is advancing in the New Mexico Senate, after being cosponsored by ten of my colleagues. A similar version of the Memorial has also been introduced by Hawaii Senator Chun Oakland, and is cosponsored by ten members of the Hawaii Senate. That resolution will create an evidentiary repository for Hawaii victims, especially those with diabetes and epileptic seizures, now statistically epidemic in Hawaii, with links to aspartame.

In January 2009, Hawaii Senator Kalani English introduced SB576 in that state. It would ban aspartame entirely in Hawaii. This bill is cosponsored by an astonishing 14 members of the 25 member Hawaii Senate. At the same time, Representative Mele Carroll has introduced HB669, also banning aspartames sale and use in Hawaii.

I realize a permanent FDA Commissioner has not yet been selected by the Obama Administration, but when one is appointed, I will send a similar letter to him/her to again request this action in order to protect the American public from further harm from a chemical that the FDA has known for 43 years is metabolized as methanol, formaldehyde, aspartic acid, phenylalanine, and the proven carcinogen, diketopiperazine.

This regulatory failure of epic proportions entirely resulted from the actions of Donald Rumsfeld when he was with the original patent holder for aspartame. There is sufficient evidence to warrant such a rescinding, a situation not unlike that in 1969 when President Richard Nixon similarly ordered the FDA to take away the approval for another group of carcinogens, cyclamates, which occurred very quickly.

Our concern must be the overarching concerns of preventing further neurodengenerative and carcinogenic damage to hundreds of millions of Americans, who have no other government entity to trust and depend on than the United State Food and Drug Administration!

I believe that President Obama, Congressman Bart Stupak, and Congresswoman Rosa Delauro all want to see the rebuilding of an FDA that merits the restored trust of the American people. I certainly want to see this come about, and I hope you do as well.

Rescinding aspartames FDA approval would be a major credible first step in the right direction.

Sincerely yours,
Gerald Ortiz y Pino
New Mexico State Senator
District 12
Albuquerque

Stimulus package and your health

UPDATE: Here is the foreshadow of care rationing

New debate on how to decide best health treatments
By ERICA WERNER, Associated Press Writer, Mar 12, 09

WASHINGTON – People's lives and plenty of money are at stake when it comes to determining which medical treatments work best.

So some prominent health industry and patient advocacy groups are trying to reframe the debate over how such decisions are made in order to ensure their interests are protected.

Spurred by $1.1 billion in the recent economic stimulus bill for "comparative effectiveness research," their coalition unveiled a new campaign Thursday with a prominent Democrat and disability rights advocate, former California Rep. Tony Coelho, as its spokesman.

Coelho, who suffers from epilepsy and was a key sponsor of the Americans With Disabilities Act, said the issue comes down to whether disabled people and other patients would get the medical care they need.

"On this issue we need to be at the table," Coelho said in an interview with The Associated Press. "Comparative analysis is wonderful, if it's done appropriately."

Coelho's concerns about what could happen if it's not done right line up with those articulated most loudly until now by Republicans and conservative commentators — that "comparative effectiveness" could morph into "cost effectiveness," with bean-counting government bureaucrats refusing treatments to patients who need them.

It's a big concern for drug and biotech companies too since they could lose out if a treatment they've developed is found to be less effective than a competitor's. But a drug company's bottom line isn't likely to draw as much public sympathy as a disabled person's needs.

That makes Coelho a good face for the Partnership to Improve Patient Care, which formed as the issue began to surface last fall and is funded by groups including the Easter Seals, Friends of Cancer Research, the Alliance for Aging Research, the Advanced Medical Technology Association and the powerful pharmaceutical and biotech industry lobbies.

The partnership also includes some minority and women's groups, mostly as nonpaying members. These groups say they can be underrepresented in studies of medical procedures and want to ensure that doesn't happen with the stimulus money.

The fear is that "research done with a very limited segment of the population would be applied to everyone," Alicia Diaz, federal affairs director for the Cuban American National Council, said after the partnership's press conference Thursday.

Obama administration officials insist that won't happen, noting that the economic stimulus bill specifies that comparative effectiveness research include minorities and women, and promising that disabled people will be included, too.

The purpose of the research is to provide doctors and patients with good information to help them get the best outcomes, and improve the performance of the U.S. health system, administration officials say.

"Information about the relative advantages of different treatments is critical to helping people with disabilities be better advocates for their own care," Health and Human Services spokeswoman Jenny Backus said Thursday.

Asked whether saving money was also a goal, Backus said the first step was to conduct the research and the program is "really about quality of care."

But controversy was stoked when language accompanying a House version of the bill suggested the result of comparative effectiveness research would be that less effective and in some cases more expensive procedures "will no longer be prescribed."

The final bill had different language, specifying there was no intention to "mandate coverage, reimbursement or other policies for any public or private payer."

On the Net: Partnership to Improve Patient Care: http://www.improvepatientcare.org/
Copyright © 2009 The Associated Press.

UPDATE: The issue of electronic records and privacy concerns the public in the UK where their NHS plans to make documents avialable to pharamcists...
D. Mail 12.2.09 "CHEMISTS COULD BE GIVEN ACCESS TO PATIENT DATA"
High street chemists will be able to view patients' medical records under controversial plans, it emerged last night. But doctors - including the BMA - & campaigners warn that patient confidentiality could be put at serious risk.
------------------------------------------------------------------
I have been involved in health freedom activities since the 1960s when I worked in mental health and later on in Haight-Ashbury and at a famous commune in conjunction with the local public health nurse.

From there I stopped off at Chicago 68 and then back home to the east coast for more education in the health professions, future studies, management and whole systems design.

This is some of the path I travelled to get where I am now, an advocate for health freedom and a person known internationally for helping you learn to do the same.

Now we have a clear picture of the backwards spiral, or what you may also call positive entropy, as the system falls in on itself.

Speak Now!

Council for Comparative Effectiveness Research
Columnist George Will in the January 29 issue of the Washington Post first noted that “The stimulus legislation creates a council for Comparative Effectiveness Research. This is about medicine but not about healing the economy. The CER would identify (this is language from the draft report on the legislation) medical ‘items, procedures, and interventions’ that it deems insufficiently effective or excessively expensive. They ‘will no longer be prescribed’ by federal health programs….” Private insurers are expected to follow suit. The CER would dramatically advance government control—and rationing—of healthcare, and the natural health community will have to make its case to this governmental body.

There is deepening cause for concern regarding government involvement in healthcare as the stimulus legislation becomes law. There is abundant evidence that vested interests, which have become pervasive in every aspect of federal legislation, are pulling attention away from wellness, individual responsibility, and true innovation in healthcare. AAHF’s drive to reform the FDA stems from the fact that the FDA—which is truly our government’s involvement in medicine—is responsible for many flawed and destructive policies. The FDA:

• systematically obstructs medical science and innovation;
• forbids and censors the communication of legitimate, peer-reviewed scientific research;
• protects entrenched medical monopolies that pay the FDA’s bills and hire its employees;
• interferes with the rights of consumers to learn about good science (especially relating to food and supplements) that could prolong and save lives and promote health; and
• unnecessarily drives up the cost of healthcare to the point where employers can no longer afford to hire new employees (or even keep old ones), and the entire American economy is threatened.

Every American citizen who values health care freedom of choice must remain ever vigilant that the federal stimulus plan threatens to put a huge government footprint on their healthcare. Help us reform the FDA now!
Thank you to American Association for Health Freedom

Corruption at the FDA? You Betcha Red Rider!

What big eyes you have my dear, and now let me explain why you should avoid the digital mammography scam -

"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."

Remember to "question authority" because your life and your health depend on it.

FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR – Associated Press
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.

And as an additional comment -

Report: FDA lax in oversight in trials Published: Jan. 12, 2009

WASHINGTON, Jan. 12 (UPI) -- The U.S. Food and Drug Administration does little to oversee doctors' financial conflicts of interest in clinical trials, government inspectors said Monday.

The inspector general's report from the Department of Health and Human Services also said its investigators were told by FDA officials trying to protect patients from such conflicts was essentially a waste of time, The New York Times reported.

The agency received no forms disclosing doctors' financial conflicts in 42 percent of clinical trials of drugs and medical devices, and regulators did nothing about the problem, the inspector general said.

In 31 percent of the trials in which the agency did receive the required forms, FDA reviewers gave no indication they'd looked at the information, the inspector general said.

And in 20 percent of the cases in which doctors admitted significant financial conflicts, neither the FDA nor the sponsoring companies did anything to deal with the conflicts, the investigators found.

An FDA spokeswoman told the Times the agency did not review doctors' financial conflicts before trials because the conflicts represented only one possible source of bias.

Studies have found that 20 percent to 33 percent of all doctors who help oversee clinical trials have financial conflicts, the Times said.
Source: UPI.

Gary Null Video on FDA and other good videos

Prescription for Disaster is an in-depth investigation into the symbiotic relationships between the pharmaceutical industry, the FDA, lobbyists, lawmakers, medical schools, and researchers, and the impact this has on consumers and their health care. During this thorough investigation, we take a close look at patented drugs, why they are so readily prescribed by doctors, the role insurance companies and HMO's play in promoting compliance, and the problem of rising health care costs. We examine the marketing and public relations efforts on behalf of the pharmaceutical companies, including sales reps, medical journals and conferences. Further, we look at alternatives to traditional pharmacology and drug therapy, such as vitamins and nutritional supplements, and why they are often perceived as a competitive threat to the drug manufacturers. Alternative therapies also include diet, exercise and a healthy lifestyle. Prescription for Disaster takes you on a journey through the tangled web of big business, the way disease is treated today, and the consequences we suffer as a society.«