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

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.

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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. ...

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

If vitamins are so bad why is FDA giving them to PhRMA

Help protect your right to supplements -

Alert: Protect Your Right To Natural and Bio-available Vitamin B-6!
ANH-USA On April 6, 2010 @ 3:18 pm

Human beings cannot live without vitamin B-6. It is also important for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions. Its effect on carpal tunnel can seem almost miraculous [1].

A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.

Unfortunately, this isn’t all the bad news about vitamin B6. All forms of B-6, natural or synthetic, must be converted to P5P, another natural form, for the body to use it. Another drug company, Medicure Pharma, wants sole use of P5P and so has petitioned the FDA to ban its use as a supplement as well.

Medicure has yet to market a drug made from P5P, but wants the ban to take place now. And never mind that any individual unable to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive.

How does Medicure think it can get away with this? Its petition states rather candidly: “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”

This is not of course a case of supplement producers creating a product to compete with an existing prescription drug. It is just the reverse. P5P, the natural and bioactive form of B6, has existed in food for as long as there have been humans and has been available as a supplement for years. Medicure seems to be saying: If it seems profitable, let’s just turn a critical vitamin, one essential for human life, into a drug, make it available only by subscription, and mark up the price. This is truly outrageous.

The FDA has not yet responded to Medicure’s petition. We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s P5P grab, and the time has come to send some more messages. So if you haven’t sent in a message to the FDA and Congress yet, or even if you have, please send one today [2].

[2]

While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6 [3]. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.

Don’t let the FDA take away our access to the natural and most bioavailable form of B6, P5P. Please take action now [2].


--------------------------------------------------------------------------------

Article printed from Alliance for Natural Health – US: http://www.anh-usa.org

URL to article: http://www.anh-usa.org/alert-protect-your-right-to-natural-and-bio-available-vitamin-b-6/

URLs in this post:

[1] Its effect on carpal tunnel can seem almost miraculous: http://search.vitasearch.com/search?q=pyridoxine+carpal+tunnel+syndrome&restrict=Summaries&site=CP&client=CP&proxystylesheet=CP&output=xml_no_dtd&filter=0&getfields=*

[2] please send one today: https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=334

[3] inked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6: http://www.physorg.com/print187978106.html

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

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

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