Florida-based Hand Hygiene Company's Senior Honcho Cited For Breach; Lawsuit Pending

"Led by Seth Freedman, Dave Mullinix and Dr. Andrew Fine, IntelligentM provides data-driven hand hygiene-related infection control solutions for hospitals that dramatically reduce Healthcare Acquired Infections (HAI’s). Seth is a serial entrepreneur with extensive experience in manufacturing and technology that includes a successful track record of growing companies in the consumer goods and GPS channels. According to latest developments, on top of a string of prior civil court judgments which included both breach of contract that led to bankruptcy filings, the phrase "serial entrepreneur" might suggest something different..

Dermacare Seth Freedman Demand Letter Breach of Contract

FDA Finally Wakes Up re: Triclosan

As widely-reported by multiple news media outlets today, the FDA is finally taking a step to stem the use of triclosan in various consumer products, including hand-hygiene products aka 'antibacterial soap'.

Though an assortment of competing headlines and lead-ins miscast the latest news with titles that read "FDA seeks stricter rules for antibacterial soaps", the issue is about triclosan, not anti-bacterial soaps per se.

*In light of these data, the agency issued a proposed rule on Dec. 16, 2013 that would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

This topic has been fermenting for years, best evidenced by mentions within this blog over the past 7 years. Who says "7 is not a lucky number"?

A favorite observation on this this topic came from one of the leading experts in the field, one who prefers that his name not be attributed here : "Pour enough triclosan into a swimming pool and you'll soon discover little green monsters that look just like Martians lounging on your pool floats. Yes, I'm exaggerating, but when I cautioned the FDA folks that triclosan is a carcinogen, they asked whether the two word also rhyme."  

Wall St. Journal: Hand Sanitizers Sans (Without) Alcohol

Courtesy of the February 11, 2013 edition of the Wall Street Journal (Laura Joahnnes, reporter)

For killing germs on your hands, alcohol has long been the go-to ingredient in many hand sanitizers. Now, some companies are selling alcohol-free sanitizers with antimicrobials they say give long-lasting protection without drying hands.

Editor note:  Various companies have been promoting alcohol-free hand sanitizers for the past 10+ years. In 2009, Gojo Industries sued the owners of the leading alc-free brand ("Hy5") for "irreparably damaging Gojo and its product Purell by making claims that suggested alcohol hand sanitizers irritate the skin. 

Some scientists say there is insufficient real-world evidence to show the new sanitizers work as well as they do in lab tests.

Many hand sanitizers, which gained popularity in the 1990s, contain alcohol, which provides a quick kill but evaporates in a few seconds—meaning users can pick up more bacteria as soon as they touch something, scientists say. And frequent users of alcohol-based sanitizers, such as nurses, sometimes complain of dry hands, doctors say.

The website of SafeHands LLC, Boca Raton, Fla., markets its alcohol-free sanitizer, made with the antimicrobial benzalkonium chloride, as "tough on germs and safe on skin." Another sanitizer, 4 Hour Protection sold by Angel Dough Ventures LLC, Hicksville, N.Y., has the same active ingredient and offers "moisturizing, long-lasting coverage," according to the company's website.
Zylast from Innovative BioDefense Inc. in Lake Forest, Calif., is made with an antimicrobial called benzethonium chloride. According to its website, Zylast is "persistent for six hours," which the company says means it maintains a reduction in bacteria six hours after application.

The nonalcohol antimicrobials—which are in a chemical family called quaternary ammonium compounds, or "quats"—do kill germs, scientists say. But they say alcohol-based sanitizers have more published research showing real-world benefits, such as lower incidence of illness among college students or reduced infections in hospitals.

For this reason, the Centers for Disease Control and Prevention recommends alcohol-based products—in addition to handwashing—for health-care workers, says Katherine Ellingson, an epidemiologist at the CDC. For the nonalcohol antimicrobials, "we need studies to look at clinical outcomes," such as reduced transmission of infection in health-care settings, she adds.
Editor note: This is exactly what CDC has been saying for the past 7 years. They also say it is not their role to perform studies. Consultants to CDC include select individuals who are full-time advisers to GOJO Industries.

To show Zylast works for hours, Innovative BioDefense funded a study done at Pace University in New York that tested the product by applying it to swatches of pig skin. After a specified amount of time, the swatches were then put into contact with a bacterial sample. According to a copy of the unpublished report, Zylast lotion killed 98% of E. coli bacteria at two minutes after application, 88% four hours after application and 89% at eight hours. Innovative BioDefense says a study is under way testing Zylast's effect on elementary-school absenteeism, and additional research is planned on illnesses on cruise ships and in nursing homes.

The formula in 4 Hour Protection hasn't been studied to see how it performs after drying on skin for several hours, says Don Muir, executive vice president of MicroArmor Inc. of Willoughby, Ohio, which makes the product for Angel Dough. But he says published data in the August 1998 journal of the Association of periOperative Registered Nurses on a sanitizer with the same active ingredient shows sustained activity. The study used a formulation that was a precursor to the one used in the SafeHands product, according to David L. Dyer, who is a co-author of the study and co-inventor of SafeHands.

It is true quats linger on the hands while alcohol evaporates in 10 or 20 seconds, says Jason Tetro, a microbiologist at the University of Ottawa in Ontario. Mr. Tetro works in a university lab that does tests for hand sanitizers, including Purell. But in real-life use, quats in their dry state may not effectively kill bacteria as moisture is needed for their action, he adds, or they could rub off or get covered by dust. "You will have a much less dramatic persistence in the field," he says. "It's no fault of the product. It has to do with the way we live."

Jesse Cozean, vice president of research and development at Innovative BioDefense, says it is true the company's test doesn't translate directly to real-life benefits but it does show the product is more likely to provide lasting protection than alcohol-based sanitizers.

MicroArmor's Mr. Muir adds not all of the 4 Hour Protection product will rub off and moisture on the hands is enough to allow it to work. The company's website says the product provides "continuous effectiveness" when applied every two to four hours along with handwashing.

Dr. Dyer, who is a molecular biologist and a paid consultant to SafeHands for research and development, says he agrees with the CDC that "there is a paucity of clinical studies associated with alcohol-free sanitizers." SafeHands is planning three clinical trials on its product that will look both at the skin condition of nurses and other users, and at how use of the product affects transmission of infections in hospitals, he adds.
As proof that its nonalcohol sanitizer doesn't dry or irritate the skin, SafeHands points to a company-funded study performed at California State University, Fresno. In the test of 20 volunteers who used the product 10 times over several hours, no redness or other visual signs of irritation were seen; one subject complained of mild itchiness.

According to Dave Macinga, a microbiologist for Gojo Industries Inc., the maker of Purell, a popular hand sanitizer that has ethyl alcohol as its active ingredient, it is an "absolute misconception" that alcohol-based sanitizers dry your hands. He also says moisturizers are added.

In a Gojo-funded study published in 2000 (13 years ago) n the journal Infection Control and Hospital Epidemiology, 32 nurses used Purell for two weeks for an average of about twice an hour during their workdays. It found Purell caused no hand irritation or dryness and proved gentler on the hands than soap and water. The study used an older formula replaced last year with Purell Advanced, an alcohol-based product the company says is more effective at killing bacteria and even easier on the skin.

Calling All Germs-Hand Hygiene and Cell Phones..Duh

WSJ reports on hand hygiene facts and cell phones..
Should you apply hand sanitizer to your cell phone?
If so, what happens to your phone?!

1. JUST DO NOT EVER USE ANY WIPE OR SPRAY THAT CONTAINS AMMONIA!!
   alcohol wipes, etc are great and so handy. keep in mind that about half the wipes you find now aren’t alcohol wipes but contain benzalkonium chloride instead, which is also a disinfectant, but is replacing alcohol in many cases as it’s less drying, not able to be abused by goobers and is gentler on your skin. just make sure your wipes aren’t linty!
   *sometimes i grab a little hand sanitizer foam in the dr. or clinic and dampen my phone with it. ..just don’t wet it!

click here for link to WSJ article.

Hand Sanitizer Cocktails Send Teens To California Hospitals

According to a ridiculous column in today's "Huffington Post.."Hand sanitizer is supposed to kill germs, but some southern California teens are using it kill brain cells as well. In the last few months, six teenagers have shown up in two San Fernando Valley emergency rooms with alcohol poisoning after drinking hand sanitizer, according to the Los Angeles Times. This insane use of hand sanitizer has public health officials worrying that it's just the start of dangerous trend. Hand sanitizers use a formula up to 62 percent ethyl alcohol to kill germs, but some students desperate for kicks are using salt to separate the alcohol from the sanitizer, and making a potent 120-proof liquid equal in strength to a shot of hard liquor..."

Here's the insane part: the topic of kids (of all ages) getting sick after imbibing on alcohol hand sanitizer is hardly a new news story. This blog has been re-distributing similar stories from the US, Canada and Europe for the past 4 years.

Here's the other insane part: according to various news accounts..."Los Angeles officials are recommending that people use foam based sanitizers as an alternative to the alcohol gel products." What the officials in lala land forgot to advise is that people should be using NON-ALCOHOL, foam-format hand sanitizers. After all, whether  ingesting alcohol in foam or gel, you're still going to have the same side-effects. Here's the latest video clip

Deadly cocktail: Mouthwash, sanitizer: kasa.com

Gastrointestinal Infection Deaths More Than Doubled : #C.diff: Hand Hygiene Facts v. Fiction

Noted the New York Times, the US Centers For Disease Control (CDC) says that Clostridium difficile aka C.diff was the root cause of a doubling of US fatalities attributed to gastrointestinal infections during the ten year period from 1997 to 2007.

Aside from the head scratching caused by wondering why the recently-released study is otherwise five years delayed, the spike in visitors to this blog using key phrases "what type of hand sanitizer kills C.diff", "does alcohol kill c.diff?" and similar queries--here's what we know:
1. Alcohol rubs do not kill C.diff.
2. Alcohol rubs do however kill protective skin cells that typically block bad bacteria.
3. Benzalkonium Chloride-based hand sanitizers do not kill protective skin cells and ARE effective against C.diff (veg.)*
4.* "veg." is the "vegetative" strain, one of the two strains of C.diff. Spore-based c.Diff  is the more typical form of c.diff and is transmitted in various ways.

Alcohol-based Hand Sanitizer causes $1mil blaze at Ohio industrial facility

Inspiring one to ask: how stupid are these people?

FINDLAY, OH (THE COURIER) - A blaze that destroyed a Findlay recycling business has been ruled accidental.

The fire struck g2 revolution, 200 Stanford Parkway, on Nov. 18 after a repairman left a furnace on while repairing it, according to the State Fire Marshal's Office.

The furnace was designed to run on alcohol-based hand sanitizer, according to the fire marshal. About two gallons of the liquid ignited in the furnace and dripped into a nearby container holding 275 gallons of hand sanitizer, according to the state agency.

#Triclosan Danger: FDA In the Pocket of Manufacturers :NYT Report

Once again, media reports about the dangers of Triclosan and efforts by both consumer groups and health care advocates to block the use of this chemical in hand hygiene, facial washes and toothpaste products are being impeded by the FDA.

According to this NYT report, the US FDA has for years repeatedly deferred from making any comments as to the potential dangers of triclosan, and ignored repeated scientific findings which have found this chemical leads to resistance against various bacteria, despite findings reached by among others, the US Environmental Protection Agency (EPA), which found that triclosan in high concentration is a carcinogen.

Why would the FDA repeatedly ignore multiple and unrelated demands to block this product from use in consumer healthcare products?

Perhaps its the same reason why the US Securities & Exchange Commission (SEC) has a similar and long history of ignoring complaints against major banks; both of these agencies have a long history of deferring to their most significant constituents; the companies that profit the most from selling the products that are supposed to be 'regulated' by these inept federal employees, many of whom bide their time in cubicles until they get rewarded with high-paying private sector jobs from the companies they've been 'regulating' for years. 

The responsible alcohol-free hand sanitizer makers use benzalkonium chloride as the anti-bacterial agent in their products, and leading health care venues have already prohibited triclosan-based soaps and sanitizers.

#Alcohol-Hand Sanitizers increase #norovirus risk: study says

A survey of 161 long-term care facilities in the United States presented at an American College of Preventative Medicine meeting in February revealed an association between the preferential use of alcohol-based hand sanitizers for routine hand hygiene with an increased risk for outbreaks of norovirus, the highly infectious virus that causes most cases of acute gastroenteritis

Of the 45 facilities that reported preferential use of alcohol-based hand sanitizers in a recent survey, 53% experienced a confirmed outbreak of norovirus, compared with 18% of the 17 facilities that used hand sanitizers less often than soap and water.

"...these findings indicate that alcohol-based hand sanitizers might be “suboptimal in controlling the spread of noroviruses,” said Dr. David Blaney of the Epidemic Intelligence Service at the US Centers for Disease Control and Prevention (CDC).

Other studies have demonstrated that alcohol-based hand sanitizers are often ineffective against nonenveloped viruses, including norovirus, suggesting their use may not be appropriate in settings that frequently experience outbreaks, such as long-term care facilities..

for the full story:  http://www.cmaj.ca/site/earlyreleases/10aug11_hand-sanitizers-may-increase-norovirus-risk.xhtml

The #Buzz from too much #alcoholhandsanitizer

Research experts at the University of Florida have found yet another reason not to use alcohol-based hand sanitizers. The latest academic study, first made public on May 12, has become the subject of global news coverage.

Lobbyists for the makers of alcohol-based hand sanitizer products have yet to comment on the latest independent study that raises yet more alarms for a outdated healthcare product that has become increasingly under fire, and not only because the product is flammable.

The study was based on daily hand sanitizer application required for use by professional health care workers, which includes workers at public and private hospitals, as well as most licensed senior care facilities.

The lobbyists and spokespeople for the largest manufacturers are expected to dispute the findings, and one industry analyst expect leading makers to argue the report was flawed because those tested represent a unique and small minority of people that are required to have clean hands.

We would say the following to that "small minority" of people who want their hands clean of bacteria and easily-transmitted viruses, and use hand sanitizer products whether they're required to or not:

"There actually are other highly effective hand hygiene products that do not rely on alcohol as an ingredient. Many of these other products are safer to use and don't irritate the skin with excessive use; a notorious "feature" of alcohol-based hand sanitizers.

In fact, since 2007, the number of alcohol-free hand sanitizer brands as increased from less than five to more than 25 that compete on a national and in some cases, global basis.

The buzz about too much hand sanitizer: MyFoxTAMPABAY.com