Showing posts with label Quackery. Show all posts
Showing posts with label Quackery. Show all posts

Saturday, October 27, 2012

Federal Judge Grants permanent injunction against Oregon herb and supplement manufacturer

The Food and Drug Administration on Thursday announced a permanent injunction against Alternative Health & Herbs Remedies of Albany, Ore., and Truman Berst who runs the company - for operating outside of dietary supplement regulations. The herb and supplement manufacturer marketed alternative herbal medicine with claims they treat diseases.
 
The following products are included: herbal tinctures, capsules, topical products, eyewashes, and compresses with such names as Eyebright Leaf, Fennel Seed, Nerves, Truman’s Hoxy Tumors BeGone and Bilberry Complex.
  
For instance one product named in the injunction "Truman's Hoxy Tumors"  claims to: ... dissolve tumors in the body; also helps with abscesses, blood purification, cystitis, growths/enlargements, hepatitis, lymphatics and skin ...
 
Here is the FDA press release folks............

October 25, 2012 - Federal judge grants permanent injunction against Oregon herb and supplement manufacturer28

For Immediate Release: Oct. 25, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Federal judge grants permanent injunction against Oregon herb and supplement manufacturer

A federal judge has granted the U.S. Food and Drug Administration a permanent injunction against Truman J. Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

Berst markets the products on his website, www.healthherbs.com1, as alternative herbal medicine for serious disease conditions, such as cataracts, viral and bacterial infections, and cancer. Under the Federal Food, Drug, and Cosmetic Act, a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Berst’s products are drugs which have not been approved by FDA for their claimed uses.

“This company has ignored previous FDA warnings and has continued to produce and distribute products in violation of federal law,” said Melinda Plaisier, FDA’s acting associate commissioner for regulatory affairs. “The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”

The products include herbal tinctures, capsules, topical products, eyewashes, and compresses, and have names such as Eyebright Leaf, Fennel Seed, Nerves, Truman’s Hoxy Tumors BeGone, Bilberry Complex, Can Free, Skin Tumors, Antibiotic, Truman’s Symplex Powder, and Black Salve.

U.S. District Judge Michael Hogan of the District of Oregon, Eugene Division, ruled on September 20, 2012, that Berst violated federal law by distributing unapproved and misbranded drugs. The court ordered, Berst to stop distributing his products until all treatment claims are removed from his website, an expert reviews the products claims, and the FDA authorizes resumption of operations. Under the order, the FDA may take action against Berst for failing to comply, including requiring him to stop product distribution and to recall products on the market.

The FDA sought an injunction after Berst failed to comply with previous warnings, continuing to market products in violation of federal law. Berst is appealing the injunction with the 9th Circuit Court of Appeals.

For more information:
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 10/25/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
 

Wednesday, November 9, 2011

Hepatitis C - Beware of fake TV doctors in Egypt

Beware of fake TV doctors in Egypt
By Amina Abdul Salam - The Egyptian Gazette

Wednesday, November 9, 2011 02:18:28 PM

CAIRO - A doctor prescribed a treatment that causes cancer on a satellite TV channel. Another doctor swindled his patients by advertising herbs that were supposed to get rid of various diseases. A third one misled viewers by claiming he had a drug against hepatitis C.

These ‘doctors’ appear on private satellite channels created after the revolution, while the Ministry of Health does nothing to counteract or contain this medical chaos.
According to Dr Mona Sabe’, specialised on skin diseases, the revolution cannot be blamed for the appearance of fake doctors who are only interested in financial gain. She thought no other country in the world faced this phenomenon.

“One so-called doctor advised viewers to use a certain medicine to treat diabetes, but the whole thing was a farce! It reflects the fact that there is no supervising body,” Dr Sabe’ noted.
She is appealing to the Ministry of Health to protect people’s health. One of those who claimed to be a doctor had to go to jail. When he was released, he advertised his invention of an unlicensed shampoo, she added.

Dr Anwar el-Hemili, professor of neurology, noted that medicine was now being prescribed on air. These programmes had to stop and the broadcasters in question prosecuted.
“The main task and responsibility of these programmes is to correct wrong medical concepts, not give a diagnosis on air”, Dr Hemili said. He added that so-called doctors were talking about brain surgery without knowing anything about the subject.
This malaise required coordinated efforts between the Health Ministry and the Doctors’ Association.

For his part, Dr Adel el-Rakeeb, professor of the liver and digestive system at Al-Azhar University, called these TV doctors charlatans. Playing with people’s health was a serious matter. He told the Radio and Television magazine that those claiming to be doctors were misleading people, abusing the current lack of control and absence of an ethics committee at the Doctors’ Association and the department responsible for granting medical licences.
Dr el-Rakeeb mentioned that another charlatan appeared on satellite TV, announcing that he had discovered a treatment for HVC. Dr el-Rakeeb investigated the claim and found out that the so-called new treatment was a LE3,000 injection containing plain water and harmful materials.
Some self-proclaimed doctors claimed that they were able to overcome obesity and reduce weight. If they were real doctors they would have done blood tests with their patients before prescribing a diet.

Dr el-Rakeeb recommended that those who wanted to lose weight should go to the Nutrition Institute or the National Research Centre, which dealt with people’s health on the basis of proper medical science, and that the Ministry should take legal action as far as fake doctors were concerned.

Dr Abdul Hamid Abaza, Assistant Health Minister, stated that the Ministry of Health had contacted these satellite channels on several occasions and asked them not to expose the viewers to health risks, and that the former Minister of Health had submitted a report to the Public Prosecutor.

“We are concentrating on raising people’s awareness, hoping they will stop watching such programmes, until legal safeguards are in place.”

Monday, May 30, 2011

Stem Cells; Searching For A Cure

A few days ago I ran across an interesting article at Stanford Medicine Magazine entitled; "Peddling hope". The author Krista Conger wrote in detail about desperate and dying patients paying an exorbitant amount of money for injections of mysterious concoctions of "cells" which apparently cure just about every ailment known to man. These therapies are promoted by unscrupulous enterprising entrepreneurs through numerous websites online. The informative article sheds a light on the unfortunate patients who travel abroad to these facilities dubbed "stem cell clinics" searching courageously for a cure. The author writes;
“Harm is being done at a lot of levels,” agrees Loring. “But on the list of things that offend me, the false hope they offer to patients is at the top.”
But the hope is cleverly packaged. “These clinics never promise a patient will be healed,” says Sipp. “They’ll say things like, ‘most patients experience an improvement.’ And, when you’ve spent a lot of your own money, or money that was given to you by friends or relatives, the incentive to report that the treatment helped is very strong. There’s a lot of room for the placebo effect.”
“It’s a worldwide industry,” says Sipp, who estimates there are about 300 clinics that offer what they claim to be stem-cell-based treatments for everything from autism to diabetes, from ALS to cancer. “And recently we’ve been seeing a growing complement of places in the United States that either refer people to nearby international clinics in Mexico or the Dominican Republic for the treatment, or even perform procedures domestically.”

By tracking the number of patients some of the bigger clinics state they have treated, Sipp has concluded that tens of thousands of people may have received unproven stem cell treatments worldwide during the past decade, which indicates a market size approaching $1 billion.

Please do read the full article here.

In Germany a clinic offering experimental stem cell injections was shut down in August 2010 because of the death of an 18-month-old boy after a brain injection. The clinic "XCell" also has a clinic in Dusseldorf and one in Cologne,Germany although both clinics are now closed. Here is the article;
Europe's largest stem cell clinic, which is at the centre of a scandal over the death of a baby given an injection into the brain, has been shut down.

08 May 2011

The closure of the XCell-Center in Dusseldorf follows an undercover investigation by The Sunday Telegraph into its controversial practices, which attracted hundreds of patients from the UK. The clinic charged patients up to £20,000 for stem cell injections into the back and brain despite a lack of scientific proof that the treatments actually worked.

Experts in stem cell research had accused the clinic of preying on vulnerable patients, desperately seeking a cure for such illnesses and diseases as cerebral palsy, multiple sclerosis, autism, Parkinson's, Alzheimer's, heart disease, diabetes and spinal cord injuries.

While most other European countries - as well as the US, Canada and Australia - have banned stem cell treatments unless shown to be safe and effective, XCell had exploited a loophole in German law allowing it to charge for the experimental procedures.

But last week, the clinic suddenly announced it had ceased carrying out operations due to what it described as legal changes in Germany. In a posting on its website, XCell said last week: "Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center. Regretfully for this reason, we must cancel your appointment until further notice. We will notify you for further updates about the matter."...full story here.

This "60 Minutes" show previewed in 2010, I remember watching the it with my friend, she passed from ALS six months after being diagnosed. You can view part two of the video here.
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21st Century Snake Oil, Part 1

September 12, 2010 5:00 PM

"60 Minutes" hidden cameras expose medical con men who prey on dying victims by using pitches that capitalize on the promise of stem cells to cure almost any disease. Scott Pelley reports

 




Follow Up From U-M

Sean Morrison, director of the U-M Center for Stem Cell Biology




ANN ARBOR, Mich. — Patients should be wary of claims made by the operators of stem cell clinics outside the United States who offer unproven and potentially dangerous disease treatments, University of Michigan researcher Sean Morrison said during a segment of the CBS program “60 Minutes” that aired Sunday night.

“There are clinics that have been set up in countries with unregulated medical systems that are making claims that are not based on sound scientific and medical evidence,” said Morrison, director of the U-M Center for Stem Cell Biology.

“People who claim that they can cure diseases in the absence of strong scientific evidence are selling snake oil and preying on the hopes of desperate patients,” Morrison said during an interview conducted after the “60 Minutes” crew visited his Life Sciences Institute laboratory.
 
Clinics offering unproven stem cell therapies have arisen in countries such as China, Russia and Mexico. In many cases, there is little or no scientific evidence to support the effectiveness of treatments offered by these clinics, Morrison said. Yet patients are charged large amounts of money for the therapies, based on the promise that bone marrow or umbilical-cord-blood stem cells can cure their disease.
 
Political opponents of embryonic stem cell research in the United States have claimed that bone marrow or umbilical-cord-blood stem cells can cure more than 70 diseases. Morrison said this claim is inaccurate: To date, bone marrow and umbilical-cord-blood stem cells have only been proven effective for the treatment of blood and immune system diseases.
 
“If your doctor doesn’t have compelling reason to believe that your disease can be treated effectively with the therapy that is being offered, and if there’s no compelling evidence in the scientific literature that this treatment really is a cure, and if it hasn’t been the basis of sound clinical trials that are open to the light of day and replicated in independent clinics, then there is reason to be skeptical, and you should be very cautious about seeking treatment in those clinics,” Morrison said.
 
These clinics operate outside of the United States because the U.S. Food and Drug Administration would prevent them from making these claims or offering their therapies in the this country, due to the lack of evidence supporting the safety or efficacy of the therapies, Morrison said.
 
“The unproven therapies are not sold to patients in the United States because medical care, stem cell research, and human-subjects research are tightly regulated here,” he said.
 
Clinical trials are being launched now in this country to test whether various types of stem cells can reduce the symptoms of amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
 
Dr. Eva Feldman, director of the U-M’s A. Alfred Taubman Medical Research Institute, will test whether implantation of neural stem cells benefits ALS patients. These studies are promising. But until approved clinical trials like this one have been completed, it will remain unknown whether stem cell transplantation can help these patients, or what kind of stem cell is most effective.
 
“Stem cell research offers exciting new opportunities to cure disease, and promising research is being done in many countries throughout the world,” Morrison said. “However, years of additional research will be required to determine which diseases can be treated effectively, and how. Until that research is done, and the safety and effectiveness of new therapies are confirmed in clinical trials, there is no basis on which to represent potential new therapies as cures.”

Related;

If you want to learn more about Stem Cell Research; Click Here

These publications and references will provide a general understanding of stem cells and how they work..

Frequently Asked Questions (FAQ)

Answers to commonly asked questions on stem cell science.

Glossary

Refer to our glossary for definitions of scientific terms.

Stem Cell Facts

This downloadable brochure provides an introduction to stem cell research and contains a short glossary of commonly used terms.

Stem Cell Briefings

Read about advances in stem cell research.

Tuesday, January 4, 2011

Health authorities warn against dangerous oral supplement

This Supplement was recently discussed on the blog in an entry entitled;
"Warning Miracle Mineral Solution: ITS BACK"

by di-ve.com - editorial@di-ve.com
Local News -- 04 January 2011 -- 14:55CEST

The Public Health Regulation Department has issued a health warning on an oral mineral supplement available for sale online, stating that the product was dangerous and led to adverse effects.
The product in question is named Miracle Mineral Solution, available for sale in Europe and over the internet. Another related product, called MMS2, comes in the form of capsules.

The product’s website includes a number of grandiose claims, stating that “the answer to AIDS, hepatitis A,B and C, malaria, herpes, TB, most cancer and many more of mankind's worse diseases has been found.”

But these claims are scientifically unsubstantiated; and worse still, a number of adverse effects have been reported.

It contains a 28 per cent sodium chlorite solution which is equivalent to industrial-strength bleach, and if taken as directed, could cause severe nausea, vomiting and diarrhoea potentially leading to dehydration and reduced blood pressure, the PHRD said.

The effects could be worse if the solution is directed less than instructed, possibly causing damage to the intestines and to the blood cells and potentially resulted in kidney failure.

The department said that 1 death associated with the use of the product had been reported by the media, although it could not be officially confirmed.

It thus advised the public not to procure such a product, or to throw away any they had purchased. People who have consumed the product and feel unwell should consult their doctor.

“The department once again reminds the public that the quality, safety and efficacy of products bought over the internet cannot be always be guaranteed and advises the public not to engage in such an activity where medicinal products are concerned,” the department concluded.

http://www.di-ve.com/Default.aspx?ID=72&Action=1&NewsId=79992

Tuesday, December 28, 2010

Warning Miracle Mineral Solution: ITS BACK



WARNING>
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For 150 years there has been snake oil, quackery, and dubious people making a profit from disease. By now one would think we would recognize a sales pitch when we hear it. Instead of using logic we buy into tag lines, advertisements, emotions, paid testimonials hoping for a possible health benefit or cure. .
.,m
Once again the "Miracle Mineral Solution snake oil entrepreneur" is searching for the suffering and desperate. The snake oil salesmen is alive and well, thank you. He has just recently finished a podcast which we will discuss today on the blog. If you haven't heard of MMS then I hope to bring you up to speed. Lets begin with the FDA warning put out last summer.
 
 
Miracle Mineral Solution:
Dangerous to Drink Miracle Mineral Solution, also known as "Miracle Mineral Supplement" or "MMS," should not be consumed.

MMS is distributed on Internet sites and online auctions. MMS claims to treat HIV, hepatitis, the H1N1 flu, common colds, acne, cancer, and other conditions. FDA is not aware of any research showing that MMS is effective in treating any of these conditions.

 
The risk:
When mixed with citrus juice or other acid as directed, the mixture produces a bleach used for stripping textiles and industrial water treatment. High doses of this bleach—such as those recommended on the label—can cause nausea, vomiting, diarrhea, and severe dehydration.

Recommendations:
Stop using MMS immediately and throw it away. If you have experienced any bad side effects from MMS, contact your health care professional immediately.
 
The Podcast: 
The site who hosted the podcast , or the long and rather boring advertisement for MMS, did mention the FDA on their promo page; "The FDA says it is unsafe to take but over 75,000 people have been documented cured of malaria by MMS and millions have taken it for other ailments. Thousands of AIDS patients have returned to healthy T-cell counts from it’s use"
 
A man by the name of Jim Humble created the solution which is discussed during the podcast.
 
The sales pitch went like this; first the mention of what a generous man Mr. Humble is, in fact he donated his " gift". The podcast claimed that Mr. Humble does not manufacture or sell his miracle product he simply turned it over for others to profit from. Oh, wait, he does however have a book he would like you to buy.
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The podcast shared the remarkable price of MMS, its 20$. I waited for Jim Humble to show up on the podcast, I guess the Dominican Republic 800 number was busy and he couldn't be reached. After sometime into the podcast he was on the line. For less then 10 seconds.
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However, there was Brian, his side kick to answer all those important questions. Later, they were able to get Humble on the line to discuss MMS and how he cured HIV in Africa, he followed up with - there were no available tests to prove it. The protocol for using the drug is pretty much up to you, take it until you feel ill, then cut back.
 
During the interview when discussing the FDA and their warnings, (which came from MMS user complaints) the female interviewer seemed outraged the FDA would take the complaints seriously. The interviewer declared how ironic it would be if people on chemo called the FDA to complain of side effects. Mr. Humble again made it clear he does not sell MMS and never has. The man is a saint. The same female gave a testimonial on the solution, yes she used it.
 
The interviewers discussed Chemo a couple of times, why? I suppose if they hint at cancer, their listeners may assume MMS can be used to treat it.
 
The introduction to MMS and Humble is highlighted on the sites intro page, along with a picture of the so called chemist Jim Humble . The picture reflects a poised and smiling man wearing an Indiana Jones hat; after all he did discover this concoction in South America for goodness sakes.
 
The promo for Humble and the podcast:

"Could a cure-all really exist for diseases as cancer, AIDS, Lyme disease, chronic asthma, emphysema, hepatitis C and more? While on an expedition in Africa, chemist Jim Humble discovered that using a dilute solution of chlorine dioxide cured his two colleagues of malaria in 4 hours. Upon returning to home, he discovered that this solution which cost pennies to make had remarkable pathogen-killing properties without having a negative effect on the body. He called this solution The Miracle Mineral Supplement (MMS). The FDA says it is unsafe to take but over 75,000 people have been documented cured of malaria by MMS and millions have taken it for other ailments. Thousands of AIDS patients have returned to healthy T-cell counts from it’s use. MMS costs pennies to make and Jim Humble makes no profit from it’s sale. Join us for a fascinating show with Jim Humble as he discusses his discovery and the profound impact it has had on the people he has assisted"
 
They covered just about ever detail in the "seemly" interview format.
,
1-Price
2-Testimonial
3-Claims of unrealistic cures
4-Humble came off warm and kind
5-Humble is not selling anything, he gave it to the public
6-Book
7-FDA is just silly
.;
My friends this was a pitch for MMS. A wolf in sheep's clothing, achieved by using an infomerical podcast.
..
Its a shame the great pitchmen Billy Mays is no longer with us, now that podcast I might have at least enjoyed !

.

Monday, December 13, 2010

'Homemade' painkillers may cause liver, kidney failure

Doc: 'Homemade' painkillers may cause liver, kidney failure

Tue, Dec 14, 2010
The Star/Asia News Network

By P. Aruna

PETALING JAYA: Malaysians should be wary of "homemade" traditional medicines not prescribed by licensed practitioners.

Malaysian Chinese Medical Association (MCMA) secretary-general Dr Lim Sin Hoe said there were many unlicensed companies claiming that their products were traditional herbal Chinese medicine.

He said some spiked traditional preparations with painkillers to make it effective and eventually consumption would lead to liver or kidney failure.
He said these companies may even use names of genuine Chinese herbal medication to mislead the public.

He advised the public to consult licensed practitioners or doctors before taking any form of traditional or modern medication.

It was reported yesterday that a Singaporean woman is fighting for her life after taking pain-relieving pills from Malaysia that may be linked to her liver failure (read more).
The pills - round, black balls about 5mm in diameter - came in plastic bags with Chinese words claiming to be "homemade from secret ingredients of herbs".

K. H. Leong, 51 was introduced to the product, which claimed to treat joint pain, by a friend after she complained of pain in both her wrists.
The Health Ministry confirmed yesterday that the pills consumed by Leong were not registered with the Drug Control Authority (DCA).

According to the ministry, the victims's family was unable to provide information on where the product was distributed as it had been recommended by a friend who bought it in Malaysia.
The ministry said there had not been any previous reports of adverse side-effects to the product, but advised to stop the usage of the medicine immediately.
Those with information on the product are encouraged to contact the Pharmaceutical Services Division of the Health Ministry at 03-78413200/3342 or via email at melanie.hassim@moh.gov.my .

Sunday, November 14, 2010

Hepatitis C: FDA Sunday





Chronic Illness and Unscrupulous Websites

Today on this blog it's "FDA Sunday". For the male audience last week was "NFL Sunday", so sorry you missed it.

Small Note Of No Importance: The truth is this blogger doesn't understand NFL anything, so I might have exaggerated about last Sundays article. If you're having difficulty locating the entry please email me and I will do a search resulting with no actual information, Thank you


What is of importance on this Sunday, the 14th day of November?
Chronic hepatitis C and those questionable websites profiting from individuals suffering with chronic illness.
Therapy for Hepatitis C is an arduous treatment regimen currently with a less then desirable success rate. The majority of people infected with HCV seek out medical treatment while others search for a more alternative approach, however both groups may turn to the Internet.
The latter group of people seeking an alternative may find themselves a prime target for online medical quackery. The Internet is full of sophisticated marketing ploys with snake oil salesmen ready to take advantage of the numerous people in this unfortunate situation. The operating method used by these unscrupulous websites is to prey on the fear or uncertainty when diagnosed with a chronic illness. As humans we have an innate ability for survival at any cost. With these emotions in place it isn't uncommon to justify a few unrealistic expectations. Hence we begin a search that may lead down the path to a potentially dangerous result.
Chronic illness is a good investment for any entrepreneur especially when all ethics are effectively dismissed. Thousands of these all-purpose, herb selling, self promoting salesmen; are waiting online to finance their new enterprise.

A company can't sell their product unless they find an audience, but how can they do that, other then advertising? They create a website projecting a false impression of authenticity by peppering the site with information and or health advice. On some of these sites they cite a case study, completely void of any substantial credentials.

I find it discouraging and harmful that people who suffer with chronic hepatitis c are being directed by search engines to these commercial and profitable websites. However, there is assistance to sort out these dubious claims. On the FDA's website the public can access warning letters discharged to the owners of these websites, supplied by the CDER Freedom of Electronic Information office. The information listed below is only a sampling of what is available, for additional violations see the FDA's website .
October 12, 2010

Nature’s Health Co.
Hepatitis A, B, C and Herbs (milk thistle seed “helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver")

WASHINGTON—FDA issued a warning letter to Nature’s Health Co. LLC, Salt Lake City, in late September, after the agency determined the company was promoting several of its dietary supplements on its website using health claims that cause the products to be considered drugs. According to the agency, a range of products carry therapeutic claims that position the products to be used in the cure, mitigation, treatment or prevention of disease.

For example, products Cardiac Balance I and II and Notoginseng are promoted under a subhead “Stroke & Herbs" with claims discussing control of arrhythmia, prevention of platelet aggregation, and dissolving blood clots. Personal testimonials are also included under the subhead, related to patients with diagnosed coronary artery disease who took the Cardiac Balance products for six months and “symptoms disappeared or alleviated significantly."Other sections and products include Osteoporosis and Herbs (Shark Cartilage “keeps tumors from growing"); High Blood Pressure and Herbs (rubber tree has a “relaxant effect on coronary artery"); Hepatitis A, B, C and Herbs (milk thistle seed “helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver"); Multiple Sclerosis and Herbs; Anti-Diabetes; CancerEase (Cell Balance “reduces the viability of tumors"); Parkinson Disease and Herbs; Gonorrhea and Herbs (“Baicalein can restrain the activity of Neisseria gonorrhoeae, which is the causative agent of gonorrhea"); and Urinary Balance. FDA added, “The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter."FDA noted the products have not been approved as safe and effective for the referenced uses by the agency as new drugs.

Further, as the products are offered for conditions that are not amenable to self-diagnosis, the labeling bears inadequate directions for use, causing them to be misbranded. The agency advised the company to promptly correct any violative marketing, as failure to do so could result in enforcement action including possible seizure of products and injunctions against the company and its distributors.
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Vaccine critic "Dr. Bob" Sears blasted again.
Rahul K. Parikh, M.D., has looked closely the irresponsible advice given by "Dr. Bob" Sears in his book, The Vaccine Book." The book's centerpiece is "Dr. Bob's Alternative Schedule," which spreads vaccines over 21 visits instead of the standard 13. Parikh notes that Sears repeatedly uses "soft science, circular logic, rumors, and outright falsehoods" and that his book is "nothing more than an anti-vaccine book blanketed in a soft, sympathetic and homespun style." [Parikh RK. Face-off with the bestselling vaccine guru. Salon.com, Oct 13, 2010] Last year, in a stinging editorial, Paul Offit, M.D. and a colleague pointed out that Sears's schedule is dangerous because it significantly increases the time during which children are susceptible to vaccine-preventable diseases. [Offit P, Moser CA. The problem with Dr Bob's alternative vaccine schedule. Pediatrics, Jan 2009]
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September 2010

Enriching Gifts International
Lightning Colloidal Silver™: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."
"Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV…"
MILES CITY, Mont.—Enriching Gifts International received a not-so-welcome gift from FDA in early September in the form of a warning letter, notifying the company that the agency had serious concerns with the marketing of several of its dietary supplement products. FDA’s Sept. 8 warning letter noted it had reviewed the company’s websites and determined the way several products are promoted positions them as drugs, as they appear to be positioned to cure, mitigate, treat or prevent diseases.

Specific products were promoted in marketing files on the Enriching Gifts website, and on the on the EnzymesForDigestion.com website, an online store affiliated with the company, using claims including:
Plant Enzymes: "treatment of both Type I and Type II diabetes," "fights cardiovascular problems," "fights cancer," and "for use against H.I.V. and A.I.D.S."
Sterol Max: "has been shown to have powerful healing effects on cancer, AIDS, tuberculosis…" and "Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV…"
Aloe Ace-Max™: "important in preventing and treating arteriosclerosis, heart disease and Parkinson’s disease," "direct anti-bacterial and anti-viral effect," and "powerful healing effect on AIDS, cancer."
Pro Biotic with FOS™: "kill parasitic bacteria just like antibiotics."
Metabolic Complete™: "protection of the body against the development of cancer and heart disease."
Heart Algae™: "may significantly reduce your risk of developing heart disease and many forms of cancer."
Lightning Colloidal Silver™: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."



*Because Colloidal Silver is promoted for liver health and HCV, I included this video. The HCV community is aware of the dangers of Colloidal Silver but the newly diagnosed may not be.

As the products have not been recognized as safe and effective for the prevention and treatment of diseases, they are therefore positioned as "new drugs" in the eyes of FDA, which may not be marketed without prior agency approval. FDA’s warning letter noted the items are also misbranded, as the labeling fails to bear adequate directions for use.

Green tea claims triggers two FDA warning letters.

The FDA has issued two warning letters related to claims made for green tea products. One ordered Unilever Americas to stop claiming that its Lipton Green Tea 100% Naturally Caffeinated product has a significant cholesterol-lowering effect and is "a naturally rich source of antioxidants." The other ordered Cadbury Adams USA to stop claiming that its Canada Dry Sparkling Green Tea Ginger Ale was "enhanced with 200 mg of antioxidants from green tea and vitamin C."

August 2010
FDA Issues Warning on ‘Miracle’ Liquid
August 2, 2010
Even with this forceful warning, the product website is still live and it is full of the most unreal claims I’ve seen in any online marketing scheme:
WASHINGTON—FDA issued a warning regarding a product known as Miracle Mineral Solution (MMS) or Miracle Mineral Supplement, an oral liquid that, when used as directed, produces an industrial bleach. The agency stated it has received several serious adverse event reports (AERs), including severe nausea, vomiting, and life-threatening low blood pressure from dehydration. It recommends consumers immediately cease use of the product and dispose of it.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. In addition, the product is often marketed with multiple health claims, relating to its purported ability to support the immune system and fight conditions ranging from the common cold to cancer.
FDA is continuing its investigation into the product, and may pursue civil or criminal enforcement actions. It also asked consumers and health care professionals to report adverse events to FDA through its MedWatch program.

AcaiPure (an acai berry supplement) as a weight-loss product and Colopure (a "colon cleansing" product) as an aid for preventing cancer.
Court orders halt to supplement scam. At the FTC's request, a U.S. district court has ordered Arizona-based Central Coast Nutraceuticals, Inc. (CCN) and its owners to temporarily halt a scheme that allegedly scammed consumers out of at least $30 million in 2009 alone through deceptive advertising and unfair billing practices. Since 2007, victimized consumers have flooded law enforcement agencies and the Better Business Bureau with more than 2,800 complaints about the company. The FTC has charged CCN, Graham D. Gibson, Michael A. McKenzy, and four related companies with deceptively advertising AcaiPure (an acai berry supplement) as a weight-loss product and Colopure (a "colon cleansing" product) as an aid for preventing cancer. The defendants were also charged with deceiving prospective buyers by offering "free" or "risk-free" trial offers that opened the door to unauthorized credit card charges. The court order imposes an asset freeze, and appoints a temporary receiver over the defendants while the FTC moves forward with its case to stop the company's improper conduct. [Court orders Internet marketers of acai berry weight-loss pills and "colon cleansers" to stop deceptive advertising and unfair billing practices. FTC news release, August 16, 2010] The FTC Web site features one of CCN's deceptive television ads.
At a press conference announcing the FTC action, a VISA official stated that his company took aggressive action after the number of complaints from dissatisfied customers mounted. Under VISA's regulatory program, when requests for chargebacks (forced refunds) reach 1% of sales, sellers are pressured to modify their sales practices, but the CCN case was complicated because the company changed names several times. In a subsequent interview, another VISA representative told Dr. Stephen Barrett that more than half the companies that generate excessive chargebacks sell "nutraceuticals" (dietary supplements), but VISA's regulatory activity is focused on sales practices rather than product claims.

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Stem cell experts launch consumer-protection site.
The International Society for Stem Cell Research (ISSCR) has launched a closer look at STEM CELL treatments with information geared to help consumers make rational decisions about stem cell treatment. The new site contains a handbook of basic information that includes questions that consumers should ask a prospective clinic and discuss with a trustworthy physician. ISSCR is also querying English-speaking clinics and hopes to list which ones do or do not provide evidence that appropriate oversight and other patient protections are in place for the treatments they offer. The site invites people to submit names of clinics they want reviewed.

Power Balance products debunked.
Device Watch has examined the hype used to promote Power Balance products, which are claimed to improve balance, flexibility, strength and overall wellness. The marketers say that their wrist bands and other products contain holograms that have been "embedded with naturally occurring frequencies found in nature that have been known to react positively with the body's energy field." The marketers use demonstrations in which they purport to test whether people get stronger when wearing a product. However, the techniques used are similar to applied kinesiology muscle-testing, which relies on suggestibility. Last year, an Australian television program conducted double-blind tests that demonstrated that the tester could not determine which of six people carried a card containing the hologram. Despite the absurdity of the products, the Ovarian Cancer Research Fund is "partnering" with Power Balance to help raise funds for ovarian cancer research. [Hall H. Power Balance products: A skeptical look. Device Watch, Aug 24, 2010]

HON complaint filed against Cleveland Clinic Web site.
" The article claims that reiki is "useful" in treating all types of cancer, fertility issues, Parkinson's disease, psychological illnesses, fibromyalgia, chronic pain, digestive problems, and stress-related diseases. The article also claims that reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages.
Dr. Stephen Barrett has notified Health On the Net (HON) Foundation officials that the Cleveland Clinic Web site contains an article about reiki therapy that violates the HON Code of Conduct for medical and health Web sites.
HONcode Principle 4 requires that, "Where appropriate, information contained on this site will be supported by clear references to source data." Principle 5 states: "Any claims relating to the benefits/performance of a specific treatment . . . will be supported by appropriate, balanced evidence in the manner outlined in Principle 4." The article claims that reiki is "useful" in treating all types of cancer, fertility issues, Parkinson's disease, psychological illnesses, fibromyalgia, chronic pain, digestive problems, and stress-related diseases. The article also claims that reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages. Reiki is one of several nonsensical methods commonly referred to as "energy healing." These methods are based on the idea that the body is surrounded or permeated by an energy field that is not measurable by ordinary scientific instrumentation. Reiki practitioners claim to facilitate healing by strengthening or "balancing" the alleged force. In a traditional reiki session, the client lies down or sits fully clothed. The practitioner's hands are placed lightly on or just above the client's body, palms down, using a series of positions that are held until the practitioner feels that the flow of "energy" has slowed or stopped.
[Barrett S. Reiki is nonsense. Quackwatch, Aug 4, 2009]
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"Reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages."
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Cleveland Clinic removes irresponsible reiki article.
Shortly after Dr. Stephen Barrett complained to the Health On the Net (HON) Foundation, the Cleveland Clinic Web site deleted an article which had stated that "reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages." HONcode Principle 4 requires that, "Where appropriate, information contained on this site will be supported by clear references to source data." Principle 5 states: "Any claims relating to the benefits/performance of a specific treatment . . . will be supported by appropriate, balanced evidence in the manner outlined in Principle 4." In recent years, HON has become tougher in asking Web sites that display its seal to either substantiate challenged claims or remove them. After noting that the reiki article had been removed, Barrett asked HON to look at seven more articles on the Cleveland Clinic site.
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Stem cell clinic operator cited.
In 2009, William C. Rader, M.D. was cited by the Medical Board California and ordered to pay a $1,500 fine for violating advertising regulations and practicing under the name "Medra" without having a valid Fictitious Name Permit (FNP). An FNP is not the same as a fictitious business name statement, a local business permit, or registration with a city or county government. Having a city/county‐level permit or registration does not exempt a physician from the medical board's FNP requirement. This year, Rader obtained FNPs for Medra (incorporated 1997), Medstem (incorporated 2005), and The Dulcinea Institute. He is also set up a private corporations called The Fetal Stem Cell Institute, Inc. (2006), and a private foundation called the Cutting-Edge for Medical Invention Foundation (2001).
Since 1997, Rader has operated a stem cell clinic, initially in the Bahamas and currently in the Dominican Republic. Last year, BBC's Panorama criticized Rader's activities. One part of the Panorama report—titled "Stem cells and miracles—described the operation of his clinic and another clinic in China operated by others. Another part—titled "MS patient: The search for 'a cure'"—shows how Rader tried to pressure a woman who had multiple sclerosis to undergo his treatment. The complete broadcast can be viewed on YouTube.
This is from 2009 but still very relevant to this entry.
Nu-Liver
2009
amglo Enterprises 5/7/09

Department of Health and Human Services
Public Health ServiceFood and Drug Administration

Detroit District Office 300 River PlaceDetroit, MI 48207 Telephone: (313) 393-8100FAX: (313) 393-8139
WARNING LETTER2009-DT-14
May 7, 2009
CERTIFIED MAILRETURN RECEIPT REQUEST
Jess KraftSamglo Enterprises19785 West 12 Mile Road, #827Southfield, MI 48076

Dear Mr. Kraft:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites in March 2009 at the Internet addresses: http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , http://www.nu-liverpc.com/ and www.storesonline.com/members/459211/hepatitis-c-herbs.htm and has determined that the products “Nu-Liver” and “Nu-Liver PC” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your websites include:
Nu-Liver (http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , www.storesonline.com/members/459211/hepatitis-c-herbs.htm )
• “Halt the progression of liver disease”
• “Nu-Liver is a non-toxic formulation of Chinese herbs, is anti-viral, anti-inflammatory…”• “[S]cientifically shown to support the immune system’s natural ability to: lower the Hepatitis C viral load, reduce or normalize liver enzyme levels, and halt disease progression….”
• The URL address http://www.hepatitisc-remedy.com/ where you sell the product suggests that “Nu-Liver” is intended for use in treating or preventing hepatitis C.
Under "Ingredients in 'Nu-Liver Herbal Formula":
• “Sophora Root inhibits viral replication. Lowers viral load. Protects against fibrosis. Reduces destruction of liver cells.”• “Bupleurum root is used in chronic hepatitis, enlarged liver…and reduces inflammation by inhibiting prostaglandin production.”
Under "In-Depth Review of Herbs Used in NU-LIVER":
• “Clinical trials have demonstrated that bupleurum is a safe and effective treatment for hepatitis C and other chronic liver problems.”
• “[P]rivet fruit was found to prevent breakdown of the immune system when cancer patients were given chemotherapy and radiation therapy.”
• “Lycium Berry-Wolfberry Fruit…The fruit can kill many kinds of cancer cells in vitro because it contains germanium which has been demonstrated in Japanese studies to have anti-cancer activity. The berries…can inhibit the precipitation of fat in liver cells and promote the regeneration of the liver.”
• “[L]ovage root is effective in treatment of headaches by decreasing vascular resistance while increasing blood flow in the brain. In recent years, it has been used in the treatment of coronary heart disease and angina pectoris. The herb dilates the capillaries and other blood vessels and thus lowers blood pressure.”

Examples of some of the claims on your websites in the form of testimonials include:
• “I had suffered from fatigue for many years and discovered I had hepatitis c after a routine blood workup. I started on a regimen of interferon recommended by my doctor, but this only made me very sick. . . After going off treatment, I read as much as I could about natural ways to combat my Hep-C, and decided to try your product- Nu-Liver. What a world of difference it has made!”

Nu-Liver PC (www.hepatitisc-remedy.com, http://www.nu-liverpc.com/ )
• “What makes “PC” so special is…its ability to repair injured liver cell membranes that have been damaged from attack by internal and external toxins, especially viruses (i.e. hepatitis c and hepatitis b).
”• “[L]icorice root…acts on the endocrine system and the liver, and has been effective in treating hepatitis and cirrhosis in the Chinese population.”
• “Extensive research has revealed that the ingredients in ‘Nu-Liver PC’ protect the liver against damage from infection due to viral, bacterial and fungal causes…”
• The URL address http://www.hepatitisc-remedy.com/ where you sell the product suggests that “Nu-LiverPC” is intended for use in treating or preventing hepatitis C.
Under Licorice Root [an ingredient]:
• “[A]n acid that has proved to be both anti-bacterial, anti-viral and anti-tussive. Its anti-inflammatory action acts like the steroid ‘cortisone’, but without cortisone’s immune-suppressing side-effects.”• “Licorice . . . promotes healing of this vital organ. The herb’s anti-inflammatory properties help calm hepatitis-associated liver inflammation. It also fights the virus commonly responsible for hepatitis…”
• “Licorice root extract lowers liver cancer rates in hep c patients”
Under Phosphatidylcholine [an ingredient]:
• “'PC’ had the following liver-protective effects:
o Membrane damage was slowedo Cell death, fibrosis and fatty infiltration of the liver tissue were diminishedo Membrane integrity was conserved”
• “When “PC” was orally administered, liver cell membrane damage was slowed, and cell death, fibrosis, and fatty infiltration of the liver tissue were all diminished.
Examples of some of the claims on your websites in the form of testimonials include:
• “My liver enzymes were less than half of what they were only 3 months ago.”
• “[M]y high liver enzymes have returned to normal levels.”

Further, your websites cite a number of articles regarding the use of your products or their ingredients for treatment or prevention of hepatitis. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following are examples of reference citations used to market "Nu-Liver PC" for disease treatment or prevention on your website:

• ”Iino S. Tango T, Matsushima T, Toda G. Miyake K., Hino K., Kumada H. Yasuda K, Kuroki T, Hirayama C, Suzuki H.Therapeutic effects of stronger neo- minophagen C at different doses on chronic hepatitis and liver cirrhosis.Hepatol Res. 2001 Jan 1;19(1):31-40.”
• "Hikino, 'Natural Products for liver diseases' 1988 Economic and Medicinal Plant
• Research Volume 2(39-67))"
.• "Fujisawa Y. Sakamoto, M, Matsushita M, Fujita T., Nishioka K., Glycyrrhizin inhibits the lytic pathway of complement -- possible mechanism of its anti-inflammatory effect on liver cells in viral hepatitis. Microbiol Immunol. 2000; 44(9): 799-804."
• "Wang ZY, Nixon DW. Licorice and cancer, Nutr Cancer. 2001; 39(1):1:11"

The reference citations and other claims are supplemented by metatags used to bring consumers to your websites through Internet searches. Examples of these metatags include “liver disease treatment,” hepatitis C treatment,” “hepatitis C remedy,” “hepatitis remedy” and “liver disease remedy.”

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Your products “Nu-Liver” and “Nu-Liver PC” are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Mr. Steven B. Barber, Director, Compliance Branch, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions, you may contact Mr. Barber at 313-393-8110.
Sincerely,
/S/
Joann M. GivensDistrict DirectorDetroit District Office
Cc:Jesse KraftSamglo Enterpriises
27920 Arlington Drive
outhfield, MI 48076




Information About Milk Thistle And Herbs
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Saturday, November 6, 2010

Counterfeit/substandard medicine:Snake Oil Vendors of the Modern Era


Pharmaceutical Chicanery: Snake Oil Vendors of the Modern Era
Nov 6

Are you sure you know what you are getting inside that box of prescription medicine? Two recent newspaper articles have offered very interesting and varying perspectives into a disturbing growing international trend in the pharmaceutical industry.
Misrepresentation in the pharmaceutical industry is nothing new of course, likely as old as the industry itself. Historical anecdotes abound of snake oil charlatans and magic elixir peddlers. What distinguishes the current trend of marketplace fraud and counterfeiting, however, is its apparent swelling ubiquity.


Rama Lakshmi in the Washington Post reports that India, which has grown into the world's largest manufacturer of generic pharmaceutical drugs, has also become a thriving center for counterfeit and substandard medicine. Slickly packaged and often labeled with the names of legitimate multinational drug companies, the fake drugs are passed off as the real thing to Indian consumers and even sold abroad in several developing nations. Fraudulent tactics include using lesser amounts of the medicinal ingredients as noted on the packaging, filling vials of supposed liquid medicine with water, and recycling expired medicine by simply pasting new expiry date labels onto the box.


The practice is becoming so widespread in India that some estimates peg the amount of counterfeit and substandard drugs as high as a quarter of the entire industry. This is in stark contrast, however, to the Indian government's own conservative estimate around half a percent, an obvious attempt to downplay the severity of the issue. In any case, officials in the country are noting that the shady black market industry is tarnishing the reputation of India's budding pharmaceutical industry which, in addition to production for domestic use, also seeks wider export markets in Latin America and Africa. Within the last year, both Nigeria and Sri Lanka have had to deal with issues arising from fake or substandard Indian medicine. The Nigerian incident was a strange one, involving Chinese manufacturers slapping 'Made in India' labels onto the shipment.


The Indian government, however, is not sitting entirely idle on the situation. Lakshmi reports that the country's health ministry has recently launched a whistle-blower program with a reward of $55,000 to anyone who provides information on fake-drug manufacturers. Measures are also being undertaken to strengthen laws and speed up prosecutions. Arrests have increased over the past four years, but only marginally. In spite of the tough talk, what is disturbing is the lack of enforcement. Lakshmi's article indicates that only a measly $6.5 million of bad medicine was seized during this period.


Legitimate drug companies themselves have resorted to using holograms or embossed logos on their products, only to find that these are eventually replicated as well. One company, MSN Labs, is experimenting with a strategy whereby consumers can verify the authenticity of their purchase through text messaging.


The counterfeit drug industry, however, is not limited to India or the developing world for that matter. Worldwide, the clandestine industry is estimated to be worth about $90 billion, causing the deaths of almost 1 million people a year. Governments and big business are of course reluctant to discuss the severity and complexity of a problem that has no quick fix or quantifiable extent. Most of the data on counterfeit drugs is kept secret by the pharmaceutical industry and by governmental agencies. Drug companies employ investigators to track down and facilitate the shutting down of counterfeit industries, but this occurs very much in private, according to a 2005 Public Library of Science report.



The report states that an agreement between the FDA and US drug companies to report counterfeit cases is not mandatory.
Big Pharma companies operating in the West are not immune either from their own fair share of fraudulent activity. The line between counterfeiting and misrepresenting ineffective product appears to be growing less distinct. On October 27, 2010, Gardiner Harris and Duff Wilson of The New York Times reported that GlaxoSmithKline, the drug behemoth from the UK, settled a number of civil and criminal actions to the tune of $750 million alleging that the company knowingly sold over twenty drugs with questionable safety standards including contaminated infant ointment and a completely ineffective antidepressant. This was kept from public scrutiny until a former quality manager from the company came forward to blow the whistle on their dubious practices in one of their most productive facilities.


Whistle-blower cases against Big Pharma have become so widespread, it is reported, that Wall Street barely bats an eyelid when another such development is announced. What makes this case against Glaxo, however, so precedent-setting is that it is the first of its kind to imply that a “drug maker knowingly sold contaminated products.”


In spite of the size of Glaxo's settlement, it is by far, not the largest in history. That dubious honour goes to Pfizer in its September 2009 settlement for peddling bad drugs like bextra, geodon, and zyvox among others.


The New York Times article goes on to note that, “In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care...federal prosecutors are not only demanding record fines but are hinting at more severe actions”.


Whether or not Wall Street is paying much attention is beside the point. It is clear that Main Street, however, is still very much in the dark about the implications of such a trend, which largely remains hidden and under-reported by most mass media. “The [law]suits, all filed under seal, have for years been rising in size and scope, but the collective threat to the industry has been largely unnoticed because the growing mountain is obscured by a wall of judicial secrecy. Each successful claim begets more suits, with more being filed almost every week.”
Just the cost of doing business perhaps...


Read more: http://www.digitaljournal.com/article/299902#ixzz14YkJKFB6

Wednesday, November 3, 2010

Way Back Wednesday/Medical Quackery


Phlebotomy: The Ancient Art of Bloodletting
By Graham Ford

The practice of bloodletting seemed logical when the foundation of all medical treatment was based on the four body humors: blood, phlegm, yellow bile, and black bile. Health was thought to be restored by purging, starving, vomiting or bloodletting.

The art of bloodletting was flourishing well before Hippocrates in the fifth century B.C. By the middle ages, both surgeons and barbers were specializing in this bloody practice. Barbers advertised with a red (for blood) and white (for tourniquet) striped pole. The pole itself represented the stick squeezed by the patient to dilate the veins.

From
The Project Gutenberg EBook of Bloodletting Instruments in the NationalMuseum of History and Technology, by Audrey Davis and Toby Appel
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To distinguish his profession from that of a surgeon, the barber-surgeon placed a striped pole or a signboard outside his door, from which was suspended a basin for receiving the blood
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Cervantes used this type of bowl as the “Helmet of Mambrino” in Don Quixote Special bowls to catch the blood from a vein were beginning to come into fashion in the fourteenth century. They were shaped from clay or thin brass and later were made of pewter or handsomely decorated pottery. Some pewter bowls were graduated from 2 to 20 ounces by a series of lines incised around the inside to indicate the number of ounces of fluid when filled to that level. Ceramic bleeding bowls, which often doubled as shaving bowls, usually had a semicircular indentation on one side to facilitate slipping the bowl under the chin. Bowls to be used only for bleeding usually had a handle on one side. Italian families had a tradition of passing special glass bleeding vessels from generation to generation.

Bloodletting came to the U. S. on the Mayflower. The practice reached unbelievable heights in the 18th and early 19th centuries. The first U.S. president, George Washington, died from a throat infection in 1799 after being drained of nine pints of blood within 24 hours. The draining of 16-30 ounces (one to four pints) of blood was typical. Blood was often caught in a shallow bowl. When the patient became faint, the "treatment" was stopped. Bleeding was often encouraged over large areas of the body by multiple incisions. By the end of the 19th century (1875-1900), phlebotomy was declared quackery.

A variety of devices were used to draw blood:



The lancet was first used before 5th Century B.C. The vein was manually perforated by the practitioner. Many shallow cuts were sometimes made.

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Spring loaded lancet

Spring loaded lancets came into use during the early 18th Century. The device was cocked and a "trigger" fired the spring-driven blade into the vein.

The fleam was heavily used during the 18th and 19th centuries. Many varieties exist. Sometimes a wooden "fleam stick" was used to hit the back of the blade and drive it into the vein. (Ouch!) The fleam was often used by veterinarians.
One American user of the spring lancet, J. E. Snodgrass of Baltimore, was inspired to compose a poem about the instrument, which appeared in the Baltimore Phoenix and Budget in 1841. He wrote:

To My Spring-Lancet
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Years have passed since first we met,

Pliant and ever-faithful-slave!

Nobly thou standest by me yet,

Watchful as ever and as brave.

O, were the power of language thine,

To tell all thou hast seen and done,

Methinks the curious would incline,

Their ears to dwell they tales upon!

I love thee, bloodstain’d, faithful friend!

As warrior loves his sword or shield;

For how on thee did I depend

When foes of Life were in the field!

Those blood spots on thy visage, tell

That thou, thro horrid scenes, hast past.

O, thou hast served me long and well;

And I shall love thee to the Last!

A thousand mem’ries cluster round thee

In all their freshness!

thou dost speak

Of friends far distant-friends who found thee

Aye with thy master, prompt to wreak

Vengeance on foes who strove to kill

With blows well aim’d at heart or head—

Thieves that, with demon heart and will,

Would fain have on they vials fed.

O, They have blessed thee for thy aid,

When grateful eyes, thy presence, spoke;

Thou, anguish’d bosoms, glad hast made,

And miser’s tyrant sceptre broke.

Now, when ’mong strangers, is our sphere,

Thou, to my heart, are but the more

Endear’d—as many a woe-wring tear

Would plainly tell, if from me tore!


Scarificator

The scarificator, a series of twelve blades, was also in vogue during the 18th Century, This device was cocked and the trigger released spring-driven rotary blades which caused many shallow cuts. The scarificator seems more merciful than the other blood-letting instruments.



Flint Cup


Blood was caught in shallow bowls. During the 17th to 19th centuries, blood was also captured in small flint glass cups. Heated air inside the cups created a vacuum causing blood to flow into the cup - a handy technique for drawing blood from a localized area. This practice was called cupping.