Surgical Mesh: The Ten Year Window

The Ten Year Window

I have spent many years in the health care industry. The outcome of the observations I have made tells me that most often it takes about 10 years for facts to catch up with drug, treatments, and device approvals.

Approvals in this arena come from the Food and Drug Administration (FDA). Commonly, because of the faster fast track system instituted now for a couple of decades, money buys the ticket to the train. When first instituted Fast Track cost a manufacturer about $330,000; now it is at least double.

This doesn’t end up doing too much for safety because, if you follow the news, you too frequently hear about a drug recall, an ineffective treatment, or medical device failures along with product liability law suits.

Surgical mesh offers no different scenario.

The FDA orders Johnson & Johnson, C.R. Bard and 31 other companies to take another look at complication rates associated with their transvaginal mesh implants.

Retropubic urethral suspension was first used in 1910. Since that time over 100 different surgical techniques for the treatment of genuine stress urinary incontinence (GSUI) have been described.

Procedures done through the abdomen have been referred to as "bladder lifts". These include procedures known as the Burch repair and Marshall-Marchetti (1949) procedure. Although these are very "old" surgical procedures, the results have proven durable over time.

Some surgeons believe that the sling surgery should be used only in certain special cases because of its higher rate of complications and because they have found the older surgery techniques to be effective.

Pubovaginal Sling Procedures 

In instances where mesh may be contraindicated the procedures can be done with natural products such as bovine, or cadaver grafts.

Your physician should discuss all options with you for your situation to help you to decide which procedure is the correct one for you.

In the early 1990s, at the time use of surgical mesh began becoming popular there were no long term studies available on the differing types of products, and few long term studies of the surgical techniques.

Vaginal mesh repair has become popular, because of access to the areas involved in surgery, ease of application using the manufacturers' needles, variable mesh sizes that can be cut to size during surgery, laparotomy is not required, the option of achieving permanent tissue replacement after failure of tissue reconstruction, and experience with similar materials.

According to Dr. Saralyn Mark, a spokesperson for COOK in the capacity of Senior Scientific Policy Advisor, surgical mesh has been used for over a decade. COOK has provided biologically-derived grafts that are not cross-linked, including grafts for pelvic organ prolapse, for about 13 years. Dr. Mark’s statement was part of her presentation in September 2011 at the FDA conference covering the problems with this product.

There are several types of mesh or similar products and they are most often used in surgery involving hernia, uterine prolapse, bladder prolapse, rectocele, cystocele, and other applications.

Synthetic mesh is found in absorbable and non-absorbable forms. Biologically derived graft material is offered in cross-linked and non-crosslinked forms.

The type of material selected and the outcome of surgery is, according to Marks, best determined by “(1) assuring that the patient is a suitable candidate, (2) performing the procedure correctly, and (3) choosing the appropriate product”.

Based on the three criteria, Marks went on to state that she reviewed numerous articles where the studies referenced one of the four types of material for implant.

COOK’s findings show that most non-absorbable synthetic mesh is made of Type I polypropylene. Outcomes for this type material suggest that there is a strong bond with mesh and surrounding tissue encapsulation. In some cases the long term tissue response is more like a foreign body reactions that may include granulation tissue, limited neovascularization, eventual fibrosis, and encapsulation.

Foreign body reactions are similar to transplant surgeries where anti-rejection drugs are commonly prescribed in an effort to reduce risk of rejection.

Absorbable synthetic mesh can rapidly degrade and does not provide long term tissue support. For this reason this type of product is rarely used.

Cross-linked biologic grafts are made with chemical agents to bond or “cross-link” collagen fibers together in an effort to reduce degradation. The material seems not to support normal movement of body cells into the graft is significantly. Because of this inflammation occurs and over time leads to a foreign body reaction and encapsulation. The tissue response of chemically cross-linked graft material has been found to be very similar to the synthetic products.

Non-crosslinked biologic grafts are minimally processed to remove cells and leave no cross-linked collagen.

They offer both mechanical strength and a platform to promote “cellular infiltration, proliferation, and remodeling of the patient’s tissue”. Long term outcome with this type product aids repair and reinforcement as the graft is replaced by connective tissue and normal blood supply.

Review of 15 years of reports using different types of graft material evaluated these studies for incidence of “(1) erosion, (2) pain including dyspareunia, (3) graft-related infection, (4) persistence or recurrence of prolapse based on objective measures (such as the POP-Q score), and (5) symptomatic recurrence.”

Of these five parameters the final evaluation specifically looked at three objective measures for each type of material: (1) erosion, (2) infection, and (3) objective measurement of recurrence. Pain and other symptomatic complaints were excluded.

Overall findings with non-absorbable synthetic mesh products had a 10% erosion rate, while crosslinked biologics had 6.2% rate. Repairs with non-crosslinked biologic grafts had the lowest erosion rate at 1.2%.

Infection rates associated with material types were approximately 4.0%.

Of course and of great concern to patients are pain and other complaints, including but not limited to forced lifestyle change and quality of life concerns.

There is great consideration given to the need for follow-up sonography to evaluate the anterior and posterior mesh positions after prolapse surgery. Reported frequently is a considerable discrepancy between the implanted mesh size and its length measured after six weeks by postoperative ultrasound.

In consideration of economic cost, the recently reported direct cost of pelvic organ prolapse surgeries were between $1012 million and $1251 million dollars. Of this $494 million (49%) covered costs for vaginal hysterectomy; $279 million (28%) were costs for both cystocele and rectocele repair; and $135 million dollars (13%) were allocated for abdominal hysterectomy.

Physician services accounted for 29% ($298 million) of total costs, and hospitalization accounted for 71% ($714 million). Twenty-one percent of all reported pelvic organ prolapse operations included urinary incontinence procedures ($218 million). If all of the reported surgeries were reimbursed by non-Medicare sources, the annual estimated cost would increase by 52% to $1543 million.

Procedures using surgical mesh are permanent. There may be benefit in first understanding long term complications as these may include mesh erosion into the vagina, bladder or rectum; painful intercourse; infection or bleeding.

The FDA has received thousands of complaints about surgical mesh. Examples follow of manufacturer and complaints filed as of 2009 -

Manufacturer Product names and Number of MAUDE* reports

American Medical Systems SPARC 65

Bard Pelvicol, Pelvisoft 64, 1

Boston Scientific Scimed Prefyx PPS, Obtryx Curved Single, Obtryx Mesh Sling, Advantage Sling System, Prefyx System Mid U, Mesh Sling System23, 1, 62, 29, 23, 78

Caldera T-Sling 2

Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor, Prolene Polypropylene Mesh 123, 72

Gynecare Secur, Tension Free Vaginal Tape 1, 4

Johnson & Johnson – Switzerland K974098 495

Mentor ObTape (K031767) 236

Sofradim Uretex TO, Avaulta Biosynthetic, Uretex Pubovaginal Sling/support kit, Bard Posterior Biosynthetic Support System, Pelvetex Polypropylene Mesh 64, 0, 27, 3, 0

*MAUDE (Manufacturer and User Facility Device Experience) data represents reports of adverse events involving medical devices received by the FDA.

Cases involving Kugel Mesh Hernia Patches involving hernia repair are also on the increase. Davol, Inc., a division of the C. R. Bard, Inc., in December 2005 issued a recall following reports that the patch memory recoil ring may not withstand stresses associated with specific surgical placement techniques. The recall extended into 2006 and a law suit was filed against this product in December 2006.

Expanded recalls into 2007 were related to memory recoil ring breaks that had caused bowel perforation, bowel obstruction, internal pain, internal fistulas, migration through the abdominal wall, and additional surgery for repair or removal of mesh, blood clots, and death caused by septic shock. A case of acute heart attack secondary to surgery for bowel fistula repair was caused by perforation from the broken memory recoil ring.

Infertility has been reported secondary to a fibrotic reaction to mesh used in surgery for repair of inguinal hernia.

Some studies report that there can be a systemic allergic reaction to polypropylene mesh used in surgical treatment. These studies found too that Polytetrafluoroethylene (PTFE - fluoride) coated mesh, DuPont’s synthetic fluoropolymer of tetrafluoroethylene, may cause a greater risk.

Many researchers determined that skin patch tests should be conducted on patients in a timely manner before undergoing any surgery using polypropylene materials.

Davol and Bard were later involved in an FDA criminal investigation related to the sale of counterfeit surgical mesh kits containing flat sheets of polypropylene.

Between 2002 and 2006 Davol sold approximately 32,000 kits worldwide. In 2005 mesh kit sales generated $11 million for this firm.

In September 2011 the FDA called for the Obstetrics & Gynecology Devices Advisory Committee to discuss the issues related to the use of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The panel discussed the use of surgical mesh and its risks and benefits based on the literature and adverse reporting data (MAUDE).

Comments were taken about proposed FDA premarket and post market regulatory strategies for surgical mesh use in POP and SUI, and reclassification from Class II into Class III.

The goal of the panel is to assist FDA in determining whether there is need for additional clinical studies (premarket and/or post market) on surgical mesh use, based on data from the published literature and the MAUDE database. 

Perhaps as we move in to the future more careful consideration will be given to evaluation based on other than journal articles and adverse reporting data.

This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Chaffin Luhana LLP

The views expressed in this article are solely those of the author, Gayle Eversole.

Transvaginal Mesh 1

http://naturalhealthnews.blogspot.com/2011/10/fda-slow-to-take-action-on-vaginal-mesh.html


http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html


http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html


http://leaflady.org/mesh2.htm

FDA slow to take action on vaginal mesh

UPDATE: 24 January 2012

Dems call for Lap-Band, mesh probes ahead of MDUFMA re-authorization

Democrats in the U.S. House of Representatives are calling for a congressional probe into a pair of high-profile medical device products – Lap-Bands and vaginal mesh – as Congress gears up for hearings and a vote on re-authorizing the Medical Device User Fee & Modernization Act.

Democrats in the U.S. House, concerned about a pair of high-profile medical devices, want the Energy & Commerce Committee to open a probe into gastric band and vaginal mesh products. SOURCE

US House of Representatives recently has been visiting my series of articles on surgical mesh.  Find them all using our search window.

5 January 2012

FDA wants new studies on surgical mesh

By Anna Yukhananov,  Thu Jan 5, 2012

WASHINGTON (Reuters) - U.S. health regulators ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place, citing a spike in the number of complications seen for female patients, including erosion and infection.The Food and Drug Administration also said it may reclassify the devices in a higher-risk category that would require manufacturers, such as Boston Scientific and a unit of Johnson & Johnson, to conduct clinical trials in people before receiving approval for sale.
The companies could not be immediately reached for comment.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). They are also used to help those with a severe overactive bladder known as stress urinary incontinence.
The FDA said it received more than 1,500 reports of complications related to the repairs with mesh from 2008 to 2010, including cases in which the mesh eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007.
The FDA sent letters this week to 35 manufacturers of transvaginal surgical mesh, requesting three-year studies of several hundred women each to study side effects, as well as the women's overall quality of life.
In July, the agency warned that complications with the mesh were "not rare" and that transvaginal organ repair using mesh may put patients at greater risk than other surgeries and treatments.
The FDA also said it was concerned about scientific studies that show a lack of clinical benefit from surgical mesh, compared to non-mesh repair.
About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 women received transvaginal repairs for stress urinary incontinence.
The agency is asking for more studies from companies that sell the mesh for POP surgery. In the case of mesh used to correct an overactive bladder, the FDA is seeking further study of use of a so-called "mini-sling," when strips of material are used around the bladder neck and the urethra.
During their lifetime, 30 percent to 50 percent of women may experience POP, with two percent developing symptoms. The condition happens when tissue that holds the pelvic organs in place becomes weak or stretched and bulges into the vagina.
Surgery to support prolapsing organs can be done through the abdomen or the vagina, either with stitches or also with surgical mesh for reinforcement.
Surgical mesh has been used since the 1950s to repair abdominal hernias, but doctors only started using the mesh for POP and stress urinary incontinence in the 1990s, a procedure that has grown in popularity.
Companies that wanted to make the mesh specifically for POP or urinary incontinence could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show their implants were similar to devices already on the market.
But during a panel meeting in September, outside advisers to the FDA recommended that the agency reclassify the devices for POP to require companies to submit additional studies. The FDA said it is considering their advice.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New York, is representing women who are suing companies that make the transvaginal mesh, with a case going to trial later this year.
"These things were basically put on the market without any significant safety testing," Grand said. "I'm hoping that all of this brings about some regulatory changes."

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

In September 2011 the FDA convened a conference on the use of TV mesh and the consideration for changing its device classification to a more stringent one.

Now the FDA is calling for comments regarding its process of classifying its own process.  You can read more about this here... 



FDA Public Health Notification: Official 2008 warning from the FDA

Serious Complications Associated with Placement of Surgical Mesh 

in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence 

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

READ MORE: TRANSVAGINAL MESH AND WOMEN'S HEALTH

What to consider before choosing surgery -

Alternatives to the laparoscopic Burch and/or paravaginal repair procedures include the following:

• do nothing and continue to experience the loss of urine
• medical (non-surgical) treatment
• lifestyle modification: quit smoking, lose weight, allergy treatment
• Kegel’s exercise: regular contraction of the muscles that allow you to stop urine in mid-stream may reduce or eliminate incontinence
• pessary use: usually a donut-shaped rubber or plastic device inserted into the vagina to support the bladder
• hormonal (estrogen) replacement therapy
• treatment with medication helps certain types of incontinence
• other surgical procedures including
  • the so-called anterior repair (performed from a vaginal approach),
  • other procedures performed in the space between the bladder and pubic bone (may be done at laparoscopy or through a large incision at laparotomy),
  • sling procedures usually done with an incision in the vagina and a 1-2" incision at the pubic hairline,
  • collagen injection (injection of a natural glue-like substance into the bladder neck), and
  • InterStim® - a nerve stimulator is surgically placed to reduce bladder irritability

Many times using a combination of several forms of treatment results in the best treatment for incontinence and paravaginal defects (such as losing weight, stopping smoking, taking estrogen replacement, performing Kegel’s exercise, and having the Burch procedure). If you have any questions regarding the above or any aspect of the proposed surgery, be sure to discuss them with your physician. SOURCE


Request our prevention article


Read more -
http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html

http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html

How FDA Approved Mesh 

Graphic Courtesy of Patrick

Latest News on Device Approval from Congress, 13 December, 2011

Aspartame:Tumours and Cancer

Here is another study in PDF: This one was shredded by G. D. Searle and FDA doesn't release them. Some pages are missing but there is enough for you to see the cancers Searle didn't want you to see. The Task Force and Bressler Report exposed that G. D. Searle filtered out the cancers and anything they didn't want FDA to see, but they were caught!

I just sent this study to Ed Johnson, an attorney who worked in the Justice Department before he started using aspartame and suffered brain tumors. I wanted him to see all the pituitary tumors they found. After reading this he said: " I noted a large number of significant discrepancies listed in the pre-notes. So significant in fact that they indicate gross negligence and incompetence on the part of the so-called "researchers."

Indeed that is the case with G. D. Searle's original studies. So much so that on January 10, 1977 in a 33 page letter, FDA Chief Counsel Richard Merrill recommended to U. S. Attorney Sam Skimmer that a grand jury investigate Searle for "apparent violations of the Federal Food, Drug and Cosmetic Act 21 U,.S.C. 331 (e) and the False Reports to the Government Act 18 U.S.C. 1001 for "their willful and knowing failure to make reports to the Food and Drug Administration required by the Act 21 U.S.C. 355 (i), and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of (aspartame)." The FDA called special attention to studies investigating the effect of NutraSweet on monkeys and hamsters.

G. D. Searle was not indicted because the defense lawyers hired both U.S. Prosecutors, Sam Skinner and William Conlon, then the statute of limitations expired. Donald Rumsfeld was hired by G. D. Searle to get aspartame approved because the FDA had tried to have them indicted for fraud, and the petition for approval they revoked.

FDA toxicologist, Dr. Adrian Gross told Congress that FDA violated the Delaney Amendment which forbids putting anything in food you that will cause cancer, and the FDA should not have been able to establish an allowable daily intake. His last words were "if the FDA violates its own laws who is left to protect the public.?" You can understand why they tried to destroy the studies proving aspartame is a carcinogen, causes birth defects and other problems.

You may have heard this before but now you actually see what one of their studies looks like, and the way they did studies. Aspartame was never proven safe and can't be proven safe. Poisons kill. Almost 100 % of independent studies show aspartame is unsafe. These are the studies of the 70's. James Turner, Atty, I think had most, although some were given to another attorney. If you read the congressional record they were discussed.

Here is a link to the congressional records in PDF. http://www.mpwhi.com/congressional_record1.pdf and http://www.mpwhi.com/congressional_record_1985.pdf

The FDA knew aspartame is a carcinogen. It's all a matter of record. Dr. Morando Soffritti should get even more awards for his work, in letting the world know this poison causes cancer. It can't be hidden any longer. Too much is a matter of record.


Dr. Betty Martini, D.Hum, Founder
Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097
770 242-2599
www.mpwhi.com, www.dorway.com, www.wnho.net
Aspartame Toxicity Center, www.holisticmed.com/aspartame

Selections from Natural Health News

Natural Health News: ASPARTAME AWARENESS WEEKEND

Sep 09, 2006

Aspartame is a molecule composed of three ingredients, aspartic acid,40% (an Excitotoxin as an isolate, product that stimulates the neurons of the brain to death causing brain damage), a methyl ester that immediately ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Aspartame: Still Harming Pregnant Women

Jul 11, 2010

EU-funded research has found that pregnant women who drink just one can of fizzy drinks containing artificial sweeteners such as aspartame, have a 37% higher risk of having a premature birth. Routinely drinking 4 or more ...

http://naturalhealthnews.blogspot.com/

Natural Health News: ASPARTAME DISEASE RAGES

Feb 23, 2005

When aspartame was news, Dr. H. J. Roberts in a press conference foretold that in 5 or 10 years we would have a global plague. And it was Dr. Roberts who declared Aspartame Disease to be a global plague and published the ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Payoffs in the US Protect Aspartame from Facts

May 30, 2008

The use of the artificial sweetener, aspartame, has long been contemplated and studied by various researchers, and people are concerned about its negative effects. Aspartame is composed of phenylalanine (50%), ...

Update on the Corn Sugar Fight

LOS ANGELES — The Food and Drug Administration has cautioned the corn industry over its ongoing use of the term "corn sugar" to describe high fructose corn syrup, asking them to stop using the proposed new name before it has received regulatory approval, The Associated Press has learned.

Looks like the big fight over the high fructose corn syrup is still blazing -

SOURCE: http://www.signonsandiego.com/news/2011/sep/15/ap-exclusive-officials-slam-corn-syrup-rebranding/

Selections from Natural Health News

Best Life? Whoa Oprah, didn't Bob tell you ?

Jan 05, 2009

Splenda (sucralose) and Aspartame make you gain weight just like high fructose corn syrup. Somehow all of these fake foods being promoted as the "Best Life" partners leave a lot to be desired. But of course this is my opinion, ...

http://naturalhealthnews.blogspot.com/

Fake Foods: Oprah, Bob and General Mills

Jan 20, 2007

High fructose corn syrup you say? Yup! the one that passes directly into your blood stream and is connected with developing diabetes. And corn again, one of those high pesticide and allergy causing foods. You've got added sugar from ...

http://naturalhealthnews.blogspot.com/

Congress undermines health with support for HFCS and Hydrogenated Oil

Nov 07, 2007

Americans have begun to ask why the farm bill is subsidizing high-fructose corn syrup and hydrogenated oils at a time when rates of diabetes and obesity among children are soaring, or why the farm bill is underwriting factory farming ...

http://naturalhealthnews.blogspot.com/

Diet soda linked to heart risks

Aug 27, 2007

Atrazine, another very toxic chemical, is used in growing corn crops. High fructose corn syrup (HFCS) A sweet problem: Princeton researchers find that high-fructose corn syrup prompts considerably more weight gain ...

http://naturalhealthnews.blogspot.com/

More about the GMO Salmon Conundrum

If you sincerely believe that the FDA's "science-based" system is trustworthy then perhaps you might read this with aplomb.  Otherwise I's encourage you to give this some real thought.

We Have Not Seen the Last of the Genetically Modified Salmon

by Dinah Everett Snyder

Aug 21, 2011

38 Agricultural organizations have signed a letter to Congressional Leaders urging them to allow the Food and Drug Administration (FDA) to complete its review of the world’s first genetically engineered fish for human consumption.

The move follows a recent amendment to the Agriculture Appropriations Bill (HR2112) that would stop the FDA from spending appropriated funds to finalize its review of the fish.

Read complete article - http://farmwars.info/?p=6726


Selections from Natural Health News

Natural Health News: GMO Salmon Coming to a Table Near You

Sep 19, 2010

I've been searching in the stores for fresh wild caught salmon for some time and have not found any. The closest I came was Organic farm raised, whatever that means. I hope with every fiber of my being this GMO salmon is ...

http://naturalhealthnews.blogspot.com/

Farmed Salmon Not Best Choice

Jan 15, 2011

You've probably heard that the FDA is considering whether to approve the first-ever genetically-engineered fish [1]. Developed by a Massachusetts-based company called ... GMO Salmon Coming to a Table Near You. Jun 26, 2010 ...

http://naturalhealthnews.blogspot.com/

What You Are Not Hearing About GMO Franken-Fish

Sep 27, 2010

AquaBounty researchers compared the allergenicity—or potential to cause an allergic reaction—of a control group of salmon to both the genetically engineered diploids and triploids. They found (PDF [8], see page 102) that the diploid ...

http://naturalhealthnews.blogspot.com/

Natural Health News: FDA Set to OK Genetically Altered Fish as Food

Oct 27, 2010

A fast growing genetically engineered salmon is a good bet for approval by the Food and Drug Administration. It would be the first genetically modified animal sold as food. Dubbed “Frankenfish” by opponents, ...

Think You Know About Thimerisol?

Natural Health News thanks our colleague, Tim Bolen, for this insightful article about Thimerisol.  Bolen notes that back in the 1930s the risk of this mercury (Hg) compound was of real concern.

Mercury is a deadly toxin - in any form.  Deadly to any living entity.  The product Thimerosal (Merthiolate) is a mercury-containing pharmaceutical compound that is 49.55% mercury.  It was developed in 1927.   More, unlike other forms of mercury, Thimerosal, is both water and fat soluble - meaning that it immediately penetrates into every part of the human body, and attaches itself wherever it wants.  When it is injected, as in vaccines, the human body's natural defense mechanisms that would work to catch and expel INGESTED forms of mercury, are completely bypassed allowing Thimerasol to quickly bind itself in places in the body we definitely DO NOT want it - like the brain.

Thimerosal has been marketed as an antimicrobial agent in a range of products, including topical antiseptic solutions and antiseptic ointments for treating cuts.  It was in nasal sprays, eye solutions, vaginal spermicides, and diaper rash treatments.  Perhaps most importantly it is used, even now, as a preservative in vaccines and other injectable biological products, including Rho(D)-immune globulin preparations. 

Despite evidence, dating to the early 1930s, indicating Thimerosal to be potentially hazardous to humans and ineffective as an antimicrobial agent it is still being used.

Crazy as it sounds, Thimerosal was not scrutinized as part of U.S. pharmaceutical products until the 1980s, when the U.S. Food and Drug Administration (FDA) finally recognized its demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and began to eliminate it from these.   In 1998, finally, the US FDA took topically used (applied to the skin) Thimerosal products off of the market - as being too dangerous. 

Insane as it sounds, the US FDA didn't seem to have a problem with that same mercury being INJECTED directly into the human body - especially into our children.  Worse, Thimerosal continues to be administered, as part of mandated immunizations and other pharmaceutical products, in the United States, and globally.

Just to bring things up to date - let's look at the most recent Australian study on the relationship between Autism and mercury: Continue reading...

Discussing FDA Current Attack on Supplements

This is from a colleague of mine who is known as the "Vitamin Lawyer".

LEF, Citizen's for Health and other groups already have action established to contact CONgress to make sure this latest round of insanity and Big PhRMA's attack on your supplemnts is stopped.

Remember that currently the FDA is telling you that wlanuts are 'drugs'.

The amount of documentation and safety information that the Food and Drug administration (FDA) now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified the Dietary Supplements Health and Education Act (DSHEA) in 1994 and now establishes a process “ominously like the one for new food additives,” according to the Council for Responsible Nutrition (CRN).

CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’

The Dietary Supplements Health and Education Act was enacted in overwhelmingly negative consumer and industry response to 1993 Congressional efforts to medicalize the supplements industry. It requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives were required to demonstrate ‘reasonable certainty’ that no harm will result from use of the new food additive.

But if you look at the section on safety requirements in the new NDI guidelines and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.

“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely. “But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed,” Mister added.

As to what now constitutes an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients, which were assumed to have been ‘grandfathered in’ under DSHEA into new NDIs was alarming enough. Ironically, the new requirements could force the industry to revert to extraction processes used nearly 20 years ago.

However, the fact that separate NDI notifications for supplements containing the same NDI are required if the supplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, means that the FDA would be “flooded” with NDI submissions if the guidance were not revised.

‘Absolute nonsense with no basis in science’

A section in the new FDA guidelines claims that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all – even if it is chemically identical to its ‘natural’ counterpart – as in the case of a number of higher dose vitamins, is particularly troubling, although not wholly unexpected.

The FDA recently argued that the synthetic organic compound, homotaurine, which was being investigated as a potential treatment for Alzheimer's disease, was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. “Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”

Marc Ullman, with the New York law firm, Ullman, Shapiro & Ullman, which represents companies in the supplements industry, said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract, but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”

from Natural Health News

http://naturalhealthnews.blogspot.com/2011/07/save-your-supplements.html

FDA Approves Remicade for Kids with Ulcerative Colitis

This is news just out about 6 PM PDT.

If you are like me and you think what this indicates then you have an idea of my concerns.  If you aren't like me here are a few of my concerns -

First of all I have to ask just why is a *kid* getting UC.  Then I ask, why do you need to select a drug that is genetically engineered and one that costs up to $25,000 a year and is administered by IV (intravenous).

Next think about the risks of the drug -

Risks include: SOURCE

• serious and sometimes fatal blood disorders
• serious infections
• lymphoma and solid tissue cancers
• reports of serious liver injury
• reactivation of hepatitis B
• reactivation of tuberculosis
• lethal hepatosplenic T-cell lymphoma (Generally only when combined with 6-mercaptopurine)
• drug-induced lupus
• demyelinating central nervous system disorders

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported with infliximab.^[18] The FDA issued a warning to doctors appearing in the respective product labeling of infliximab instructing them to screen and monitor potential patients more carefully.^[19] The FDA issued a warning to doctors that there is an increased risk of lymphoma and other cancers associated with the use of infliximab and other tumor necrosis factor (TNF) blockers in children and adolescents.^[20]

^{Now just why are you prescribing this drug to a group that you -at the very same time -} 

are you placing at risk for lymphoma and other cancers?

Seems to me that this is a very risky experiment for the benefit of Big PhRMA more than it is for a child, and their parents.

If you read the info it almost sounds like a vaccine, so maybe you should think about just why it might be a vaccine that causes the UC in the first place.  And now you want to impair a fragile immune system once again...

What about food allergy?

What about astragalus and marshmallow root?

What about flax seed oil?  (Something I have used very successfully for people with UC)

And of course there are quite a few other things you might do first, and if that is the case then look to Health Forensics to give you some sound suggestions.

Suggestions that do not increase your risk of lymphoma and other cancers.

Selections from Natural Health News

Natural Health News: The Autoimmune Epidemic: Bodies Gone Haywire ...

Mar 19, 2008

The Autoimmune Epidemic: Bodies Gone Haywire in a World Out. Worth reading, especially if you are one of those people who buy in to the latest mainstream media reports on corporate propaganda that EMF is something that does not effect ...

Natural Health News: Vaccines & Sick Buildings

Jan 30, 2011

Israeli and colleagues suggest adding sick building syndrome under the classification of autoimmune inflammatory syndrome induced by adjuvants. Nine out of ten main symptoms are present in all 5 conditions. ...

Consider Vaccination Risks Above All Else!

Jan 26, 2008

Is there a history of auto immune problems in the family because many researchers believe children may be genetically hyper sensitive to the adjuvants in the vaccines? Do I understand the difference between natural immunity and vaccine ...

Natural Health News: Sjogren's Fatigue and Cancer Drugs

Nov 10, 2008

Now you may receive it if you have fatigue from a thyroid related (generally thought of as auto-immune) dis-order called Sjogren's. Make sure if this is proposed to you that you get this information that the drug may ...

SAVE YOUR SUPPLEMENTS

NEWS RELEASE


SAVE YOUR SUPPLEMENTS


Write the FDA Now - Here's Why & How


By Scott Tips
July 19, 2011

Everyone with even an ounce of common sense has grave concerns about the U.S. Food and Drug Administration’s recently released Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. This Agency sprang this trap on both industry and consumers without seeking any prior input from us at all. It had almost 17 years to seek our opinion before coming out with this document, and now they are giving us a miserly 90 days to respond with our comments. Why is this issue so important?


The Erosion of Our Health Rights


When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed, contrary to what the mainstream media falsely reports, the law did not remove dietary supplements from the regulatory oversight of the FDA. What it did do is to remove the FDA’s arbitrary powers of life and death over supplements so that they could be treated more like foods rather than as drugs. The innovative tidal wave that was unleashed as a result of this breakout from regulatory prison resulted in some 1,000 new products a year in this market. What an incredible difference DSHEA made, and we all benefitted from the prison break. Oh, wait, the FDA’s drug-industry bosom-buddies did not benefit. And that is something they have never forgotten and have been fuming over ever since.

Not without their cohorts in U.S. Congress, the drug industry’s lobbyists have been pushing for years to hamstring DSHEA and its freedoms. For more than a decade, they have failed. But for the last several years, they have succeeded with sausage-slicing tactics that have gradually eroded DSHEA. First, there was the Adverse Event Reporting law, then the law mandating “Good Manufacturing Practices,” and after that came the so-called FDA “Modernization” Act – each one designed to ratchet up the pressure on supplements, to drive out the smaller supplement manufacturers who could not keep up with the increasing regulatory costs demanded of them by these laws that were touted as making already-safe supplements “safe,” and to gradually eliminate individual supplements. Were these laws ever truly designed to protect consumers? No, these laws had only one purpose in mind: To make supplements more expensive, less available, and to drive the consumer back into the filthy arms of the drug pushers.


This latest nonsense is straight out of the warped minds of the FDA’s Berchtesgaden nest of anti-health thugs. They could care less about good health, certainly care less about you or me. This has been proven so many, countless times over the decades of the Agency’s existence that there can no longer be even a shred of doubt. The revolving door between the drug industry and the FDA is a never-stopping one. Just witness its recent hiring of Johnson & Johnson’s executive Spielberg who was tapped by FDA Commissioner Margaret Hamburg, as the latest deputy commissioner within the Office of the Commissioner to oversee the Agency’s drug and device centers. This is not an exception, this is the rule.


The Compromise


Unfortunately, when DSHEA was passed, a compromise was reached in order to get unanimous passage. The parties agreed that all dietary supplements not marketed as of the date of DSHEA’s passage (October 15, 1994) would be “new dietary ingredients” (NDIs) for which notification would be sent to the FDA. At the time, some did not think much was wrong with this compromise. After all, most supplements had already been discovered. But, now, almost 17 years later, the health-food market is awash with these new dietary ingredients, such as resveratrol, ubiquinol, GABA, curcumin, and bioperine. Notifications to the FDA have been made for many, but what is to happen to them now, with the FDA changing the law, all on its own?

Fantasy Land
This draft Guidance is a step into fantasy land. One night the FDA went to sleep and had a wonderful dream, a dream about a land where bureaucrats reigned supreme and the common citizen answered to every edict that flowed from the lovely bureaucrats’ mouths. If the bureaucrat said jump, then the citizen would jump; if the bureaucrat said roll over, then the citizen would roll over. It was a wonderful place, this bureau-paradise. But then the FDA woke up, and the non-dream reality was not nearly that perfect, yet the urge to make it bureau-perfect remained. Hence, these constant bureaucratic attempts to whittle down our freedoms until we can only jump to the tune of some unknown functionary sitting in some unknown office thinking that he or she knows better for us than we do.

This draft Guidance is just such an attempt. It turns the law on its head by changing a very basic notification system into an approval system subject to the arbitrary whims of the FDA. It requires very safe NDIs to go through unnecessary, expensive tests so that they can meet drug-like safety requirements. In essence, this Guidance ignores the incredible, proven safety record of supplements, both new and old. The FDA can produce no dead bodies whatsoever coming from the use of these new dietary ingredients.

Yet the FDA, ignoring the many tens of thousands of actual dead bodies coming from its expensive drug-approval regulatory regime, wants to imprint that badly flawed drug-approval regime upon the dietary-supplement market. In doing so, it ignores the clear intent of Congress when passing DSHEA that “the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers” and that “the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

Flood Them with Letters
The Guidance document is not law, but it is a clear expression of how the FDA intends to enforce its interpretation of the law. This interpretation is badly flawed. And its implementation will result in unnecessary high costs, arbitrary discrimination against small- and medium-sized businesses that will put thousands of people out of work by destroying jobs in a time of economic decline, and the loss of many useful and healthful supplements.


The FDA must withdraw this Guidance document at once, consult with industry and consumers on a longer-term basis than this miserly 90-day period, and come out with a new Guidance that better reflects the realities of the marketplace and the safe track record of supplements, including those with NDIs. The FDA’s proposed document is unauthorized under Law and will guarantee a backlash of legislative action the likes of which have not been seen in this legislative arena since the passage of DSHEA in 1994. The NHF suggests that the cut-off date for NDIs either be eliminated entirely or else pushed forward to a date 15 years after 1994.


Please mail, fax, or e-mail your protest letter ( Click Here for Sample Letter) to the FDA as soon as possible, but in no event later than October 1st of this year. They need to be awakened from dreamland.


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Click here for the permanent link to this news release, use this link to inform others.
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National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.

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