Medical doctors reporting in the journal Diabetes Care  on exenatide (an aglucagon-like peptide 1 receptor agonist) concluded that, based on a double-blind, placebo-controlled, crossover 35 week(!) study of 41 obese, non-diabetic women:

“…short-term exenatide treatment was associated with modest weight loss and decreased waist circumference in a cohort of obese nondiabetic women. A subset of individuals demonstrated robust weight loss that was detected very early in the course of treatment.”

Sounds great for the pharma company, as a weight loss pill is considered the “holy grail” of drugs due to the potential for huge demand. For example, 43% of the US population would be less likely to exercise if a magic pill for weight loss were to be found
(See: http://www.americansportsdata.com/pr-fitnessrevolution.asp).

Yet getting a weight loss drug through the FDA approval process has been quite challenging in recent years.  In October, 2010, several “promising” weight loss drugs were rejected, including Qnexa (due to psychological issues and increased risk for heart problems and potential birth defects) and Lorcaserin (in part due to data of cancer in test animals). Makers of Qnexa are returning in 2012 with a revised formulation for another try.

Even after FDA approval, keeping a weight loss drug on the market can also be problematic usually due to pesky side effects. Most people are familiar with the drug Fen-Phen (fenfluramine/phentermine), the popular obesity drug that was pulled from the market about six months after its approval in 1997 because of an increased risk of heart valve problems. As a side note, its manufacturer WyethAyerst Laboratories ended up paying out more than $3.75B (that’s billion) in damages due to those pesky side effects. (See http://articles.cnn.com/1999-10-08/health/9910_08_fen.phen_1_heart-valve-pondimin-diet-drug?_s=PM:HEALTH)

In October, 2010,  the maker of the obesity drug Meridia voluntarily agreed to remove it from the U.S. market because of increased risk of stroke and myocardial infarction (more heart problems). Further, Rimonabant was also removed as users experienced thoughts of suicide as well as other issues. (See http://abcnews.go.com/Health/Drugs/fda-rejects-weight-loss-drug-Qnexa/story?id=12003374).

Even over-the-counter supplement manufacturers can run into trouble when pesky side effects like dozens of  complaints about liver damage/failure and one death crop up. The popular Hydroxycut weight loss product was pulled from the market in May 2009 because of such side effects. Hydroxycut reportedly sold more than 9 million units in 2008, estimated to be worth $180m (that’s $180 million).

Because the opportunity is huge, being able to present a drug as promising while being able to downplay the downsides can do wonders for a pharma company’s future and future stock price. And it can begin the process of gaining positive media momentum as a company moves towards submission for FDA approval.

So what is the positive message coming from researchers of Exenatide? Their conclusion is very positive:

“…short-term Exenatide treatment was associated with modest weight loss and decreased waist circumference in a cohort of obese nondiabetic women. A subset of individuals demonstrated robust weight loss that was detected very early in the course of treatment.”

Does it stand up? When you look at their data, yes, the average users of the new drug lost an average of 2.49 +/- .7 kg (5.5 lbs) while placebo users gained an average of .4 +/- .6 kG (~1 lb).  And, yes, a total of 30% of users were “high responders who lost >5% of body weight (mean of -8% +/- .5%).” This appears promising. Although rejected due to side effects, one FDA commissioner remarked that Qnexa showed the greatest promise in the market for weight loss products because users could lose 6-10% of their body weight.  So with exenatide showing similar outcomes, especially in the high responders segment, they have a real shot at weight loss drug industry stardom.

But what the data also shows, while reported, is not included in their conclusion. While 30% were high responders who lost more than 5% of their body weight, according to the researchers, “…39% were moderate responders who lost <5% body weight (−2.43 ± 0.45%), and 31% were nonresponders who gained weight (1.93 ± 0.53%).”

Doing the math, nearly 7 of 10 people who took the drug averaged a loss of a 1/2% of body weight (~1 lb for a person weighing 200 lbs).  About one pound. In 35 weeks. After taking a “weight loss” drug once per day, every day, for 245 days.

I don’t know about you, but I would think that if my marketing slogan was “I can help 7 of 10 people drop 1 lb or more in 8 months by taking my super weight loss drug pill”, my customers may not be too impressed.

But this is how it’s done. The data is real. The focus is on the average 8% loss of body weight (16 lbs for a 200 lb person) over 8 months, by just taking a pill. Beautiful. Yet let’s check that data again. The number of people tested was somewhat small (sample n=41). If the researchers split the groups into a placebo group and the active pill group, then 21 people took the active pills. Then, if 30% dropped an average 8% of their body weight, that means just 7 people (.3 x 21) achieved the phenomenal results. Even if the group was split 30 active and 11 placebo, we’re still talking at most 9 people.

7-9 people.

Because their side effects appear limited (“Subjects experienced more nausea during exenatide treatment compared with placebo, but the severity decreased over time and did not correlate with weight loss.”), the company stands a good chance of getting approval.  I wish that company good luck. If approved they will probably make millions, even hundreds of millions of dollars on their drug. Because doctors will issue prescriptions and insurance companies will pay, patients will take the weight loss pill because it may work and hey, it doesn’t cost anything other than a co-pay– like maybe $10-$20/month. For 8 months. For a one out of three chance to drop 8% of your body weight.

So what does it say about Loving Works and the Weight Balancing System when we can help more than 6 of 10 of our customers release 16 lbs in 8 weeks, without side effects?

You get to decide.

At MyLovingWorks.com, we wrote about homeopathic hCG being illegal starting in August, 2009. We released

It's now the told truth

extensive research at the Parker Convention in Las Vegas last January to the Chiropractic profession and published an article in the Journal of the Michigan Association of Chiropractors in April, 2010 (because 3 of the top 4 national magazines would not take our article).  A past blog in June predicted this action (see http://mylovingworks.wordpress.com/2011/06/23/the-predictable-and-upcoming-purge-of-illegal-homeopathic-hcg/)

HERE’S THE UPCOMING FALLOUT:

1. 7 COMPANIES THAT RECEIVED THE ENFORCEMENT LETTERS ARE GOING TO LOSE MONEY – ALOT- AND MAY HAVE TO SHUT DOWN.
Not only are these 7 companies required to provide an answer to the charges by the FDA by mid-December , they are also required to deal with purchases by all previous customers. Translation? The usual requirement is a complete refund. Alot of  money was made. Now a lot is going to be unmade.

2. EVERYONE WHO HAS BEEN SELLING HOMEOPATHIC HCG WILL NEED TO STOP OR THEY MAY BE TARGETED FOR ENFORCEMENT.
This doesn’t apply to just these 7 companies. It applies to all companies, organizations and individuals. And you can bet that more enforcement letters will be forthcoming, especially if they persist in advertising.

3. THERE IS A FIRE SALE ON HOMEOPATHIC HCG, WHICH WILL CONTINUE FOR THE NEXT COUPLE MONTHS.
Current sellers will frantically attempt to recoup some of  their inventory costs by posting “Sales” or huge discounts. A customer at GNC reported on Dec. 7 that she was able to purchase one of the products identified in the FDA enforcement letters as being “…half off. What a deal!”  Yep. What a deal. That product will be off the shelf by Dec. 15th.

4. SOME OF THOSE COMPANIES WHO WERE THE LOUDEST PROPONENTS WILL DROP THIS LIKE A HOT POTATO.
You can go to certain websites of manufacturers of homeopathic hCG and– surprise– there is not even a link about homeopathic hCG even though they were selling product as recently as 4 weeks ago. No surprise there. It’s all about the enforcement. Even though these same people were well aware the product was illegal, they sold it anyway. The risk then didn’t seem so great. It is great now. So they will attempt to whistle as they skip by– “It’s over. Nothing to see here. Move along…” to quote a typical movie script.

5.  THE GENERAL PUBLIC THAT LOVED THE RESULTS HCG GAVE THEM WILL CRY “FOUL” AND WILL INCORRECTLY POINT TO THE PHARMACEUTICAL INDUSTRY. THEY WILL MOUNT PROTESTS AND PETITIONS, TO NO AVAIL.
You can already see this in comments on the news articles pointing to the banning of homeopathic hCG. “It’s all because pharmaceutical companies can’t make any money on hCG…” or “The FDA wants to take away something that really works and replace it with drugs…” or “I didn’t have any side effects when I lost 40 lbs using homeopathic hCG” are popping up. No, it wasn’t Big Pharma this time. Six pharma companies produce hCG and have been making all kinds of money with these huge volumes. And this isn’t evidence of any conspiracy by the FDA to get everyone hooked on pharmaceutical drugs. Nope. It’s simple law enforcement. The FDA/FTC took about 3 years to address the last big boom in using hCG for weight loss in the mid-1970′s. This time, it took about the same amount of time, starting the timer at the success of Kevin Trudeau’s book in 2007 -2008 and ending the timer at the close of 2011. Yet protests will occur and petitions will be signed, especially online petitions. The law won’t change this way.

6. MEDICAL WEIGHT LOSS CLINICS AND MD’S WILL REMIND EVERYONE THAT YOU CAN STILL GET HCG FROM THEM. UNFORTUNATELY, AS THEY ADVERTISE OR PROMOTE HCG, THEY WILL BE BREAKING THE LAW, TOO
Certain licensed doctors and health providers (MD’s, DO’s, ND’s in some states, PA’s, Nurse Practitioners, etc.) can write off-label prescriptions of hCG for weight loss to their patients. But MD’s and their associated clinics cannot promote or advertise hCG for weight loss legally if the drugs come from a compound pharmacy. In addition, if they advertise non-compounded hCG, they must include a label that states the FDA does not approve hCG for weight loss. Try explaining to a state licensing board how, as a MD, you are meeting the standard of care required to support patients yet are promoting something that by definition isn’t proven to work for that use. All someone has to do is complain and you have a sticky problem. We know of a MD from Florida who is outraged that MD’s/DO’s/DC’s etc. are selling hCG for weight loss and has a personal mission to see any licensed health care provider is disciplined or loses their licenses for selling hCG. He’s been successful, as at least 2 of the 7 enforcement letters went to organizations he has or is targeting.

7. COMPANIES WILL SUDDENLY, OUT OF SEEMINGLY THIN AIR, START OFFERING “NON-HORMONE” HCG OR SOMETHING SIMILAR
These new products will be promoted in the same way, with the very low calorie diet, but without the hCG hormone. There are already a number of them on the market. They will claim that there is no “hCG” in them, yet they will follow the Simeons Protocol (highly restrictive 500 cal/day food program). The giveaway will be the 2,4 or 6 week break that you will still need to take in between rounds. If there is no hCG in the product, why do you need to stop taking their products after the first 42 day round? Because there is still hCG in the product, that’s why. If there is no break after the first round, then you have something different that does not have hCG in it. But will it be a proven product or will it be a placebo?

The fallout will continue because millions of people are overweight and will pay to drop pounds, especially quickly. The search for an effective method to help people release weight and keep it off will continue.

This is the irony of science– new theories, ideas, and discoveries are recognized as critically important to advance scientific understanding, yet acceptance of new ideas and discoveries requires meeting a high threshold of proof and validation that is based on a world view absent that new idea or discovery.

The recent Nobel Prize for chemistry awarded to Israeli scientist Daniel

quasi-crystal structure

Shechtman this month offers a compelling example. Prior to Shechtman’s discovery of “quasi-crystals,” the scientific community not only had no evidence of such structures, but the idea itself seemed preposterous.

Thirty years ago, a much younger Daniel Shechtman had looked  at a metal alloy via an electron microscope and saw a pattern familiar in Islamic art but then unknown at a molecular level. He observed atoms in a crystal forming a five-sided pattern that did not repeat itself, defying then-current wisdom that crystals must create repetitious patterns, like triangles, squares or hexagons. Scientists had previously held that solid matter had only two states — crystalline, like diamonds, where atoms are arranged in rigid rows, and amorphous, like metals, with no particular order. Quasicrystalline matter offered a third possibility.

“People just laughed at me,” Shechtman recalled in an interview this year with Israeli newspaper Haaretz, noting how Linus Pauling, a colossus of science and double Nobel laureate, mounted a frightening “crusade” against him, saying: “There is no such thing as quasicrystals, only quasi-scientists.”[1]

Shechtman was ridiculed, condemned and ostracized, eventually being asked by his head of Research to leave for bringing disgrace to their research team.

“His discovery was extremely controversial,” said the Nobel Committee at the Royal Swedish Academy of Sciences, which granted him the 10-million crown ($1.5 million) award.

“Daniel Shechtman had to fight a fierce battle against established science … His battle eventually forced scientists to reconsider their conception of the very nature of matter.”[1]

Daniel Shechtman - 2011 Nobel Prize for Chemistry

Shechtman’s discovery took nearly 30 years of struggle to become accepted.

“Astrid Graslund, secretary for the Nobel Committee for chemistry, said: “The practical applications are as of now, not so many. But the material has unexpected properties. It is very strong, it has hardly any friction on the surface. It doesn’t want to react with anything — they cannot … become rusty.

“But it is more a conceptual insight – that these materials exist and we need to re-write all textbooks about crystals – it’s a shift of the paradigm, which I think is most important.”[1]

While releasing weight using the Weight Balancing System may not elicit the same degree of derisive ridicule as that which Schehtmann experienced, we’ve encountered numerous skeptics and critics who question and skoff at our “fat mobilization can help you release 10-25 lbs per month” claims.

They feel the reduced portion plan food program is the sole source of any weight loss and that the Wt Balancer(R) dietary supplement is merely a placebo. Without clinical studies, they say, all Loving Works has are anecdotal responses from users. Independent validation is needed or else the Weight Balancing System is a scam.

They point to the usual threshold for validation– an independent, double-blind, randomized, placebo based study. Unfortunately for the disbelievers, such a study by design is incompatible to validate the Loving Works program. It is unethical to ask volunteers to submit themselves to a survival-level meal protocol with a placebo as anyone who is eating 1000 calories or less per day will immediately experience the physiological response of such low level dietary intake. Within several days, the misery of headaches, hunger, lower blood sugar and adrenal cortisol stress effect will take place. Since the placebo effect is considered to cover under 30% of participants, seven of ten volunteers given the placebo would be subjected to this experience. Try going with 500- 1000 calories of dietary intake for a couple of days and you’ll see that the response is difficult and immediate. Any study would be short-lived.

The Weight Balancing System program works best when people are ready for a change. The program’s first step– the Intention and Disconnecting Phase– requires each participant to both desire and be ready to change, to expect positive results. Proponents of double-blind studies agree that expectation can change the outcome of any method and that clinical studies can only confirm a hypothesis about a protocol if it is independent of expectation.  It is impossible to evaluate a program that uses expectation via a method that prohibits the inclusion of expectation in its validation.

Further, there is no place to obtain a truly independent organization who can perform such a study. Any recognized clinical setting will be staffed by dieticians, doctors or academicians who already carry the worldview that fat mobilization is a phantom, doesn’t exist and may even be considered (it’s been said before) preposterous. No one is independent of their own world view.

The idea of releasing weight is not new. The method used in the Weight Balancing System is new. And while we’ve had more than 7500 people use the program with less than a 1% return rate, their results will continue to be considered anecdotal by skeptics who mistrust the idea of fat mobilization.

Undoubtedly there will always be skeptics, but we trust it won’t take 30 years, or a Nobel Prize, to get to a point where people can release weight and get the benefits of the Weight Balancing System.

REFERENCES:

1- Lannin, Patrick and Veronica Ek, Ridiculed Crystal Work Wins Nobel for Israeli, Reuters Health Network, 5 Oct 2011

It’s one of the most important issues that affects nearly every part of your health.

Most people know little about circadian rhythm sleep disorders, even though millions are affected

Sleep disorders, known as Circadian Rhythm Sleep Disorders (CRSD), occur when we fail to get sufficient, restful sleep.  The lack of sleep at night triggers excessive sleepiness (ES) by day, defined as the inability to consistently achieve and sustain wakefulness and alertness to accomplish the tasks of daily living. [1] As a sleep disorder continues, we can experience insomnia (chronic inability to fall asleep and/or frequent waking and reduced ability to return to sleep), which accelerates the ES condition.  Sleep disruption may also occur due to apnea, where breathing is obstructed, reducing oxygen intake and interfering with restful sleep. The combination of being unable to sleep when desired combined with excessive sleepiness during daily living can create drastic health consequences.

Excessive sleepiness is associated with significant impairment in memory and memory consolidation, concentration, learning, and work performance.[2-5] Such impaired alertness is a leading cause of automobile accidents and workplace injuries.[6,7] Data from the National Highway Traffic Safety Administration[8] reveals
driver fatigue causes more than 100,000 crashes annually, resulting in up to 71,000 injuries and 1550 deaths. If you are a night shift or multiple shift workers, you likely already know that you are especially susceptible.
Productivity and property losses from these accidents are estimated at $12.5 billion a year.[9] Further, a survey of Americans’ sleep habits found that 46% have made workplace errors or missed work because of ES at least once during the previous 3 months.[10]

Accidents are not the only risk. ES is associated with increased morbidity related to multiple
medical and psychiatric diseases.[11-13] ES is a risk factor for hypertension,[14,15] and has been linked to higher rates of myocardial infarction, total and cardiovascular mortality, and congestive heart failure.[16] Sufficient sleep is also a critical factor to improve short-term weight loss and manage long-term weight control, making it a key factor to help avoid obesity and its related morbidity outcomes. [17]

Sleep issues affect a significant percentage of the US population. Recent studies have found that 13% to 30% of adults report sleepiness (excessive sleep time, sleepy behavior, perceived feelings of excessive daytime sleepiness, sleepiness that interferes with life).[18] A  Harvard Medical School study of 7,428 people [19] reported insomnia affects nearly one in four employees and is estimated to reduce productivity of the average U.S. worker by 11.3 days, or $2,280, costing the US approximately $63.2 billion annually.

The rate is found to be higher in people who have other negative health conditions and become patients. Even though few patients voluntarily report their symptoms [18,19], in a recent study more than 90% of patients visiting a primary care clinician were experiencing sleep-related symptoms.[20] Another study [21] revealed more than 50% of patients reported excessive daytime sleepiness and more than one third had dozed off during daytime activities.

Much remains to be done to provide help. Both you and your doctor—if you see one– likely know little or underestimate the seriousness of ES resulting from CRSD. The majority of medical doctors do not screen their patients for ES. While the reasons are understandable, including lack of perceived importance, lack of
time, limited knowledge about ES and CRSD and lack of confidence in diagnosing and dealing with this condition,[1] validated, simple screening tools, such as the 8-question Epworth Sleepiness Scale (ESS) are readily available and easy to use.

Further, when chronic insomnia or ES complaints get reported, the standard allopathic approach
is to prescribe pharmaceuticals or recommend use of the sleep hormone Melatonin. For example, while patient complaints of sleeplessness doubled between 1993 and 2007 and diagnoses of insomnia rose seven fold, prescriptions for non-benzodiazepine sedative hypnotics ( Ambien and similar drugs) soared 30-fold.[22] The push by drug companies to get more doctors to prescribe their sleep drugs has some authors feeling insomnia may not even be a disease state, but instead is being medicalized by pharmaceutical marketing forces.[22] And while Melatonin is available over the counter and provides benefit for certain conditions, especially jet lag, dosage and instructions for use can be confusing and long-term use is not promoted.[23]

Even the Chiropractic community does not have many solutions for achieving more balanced sleep.  Traditionally, chiropractors will address sleep complaints when tied to chronic pain or sleep apnea that can be remedied via spinal and autonomic nervous system adjustment. Yet the challenge of circadian rhythm sleep disorders may appear outside of the scope of traditional chiropractic services and hence Doctors of Chiropractic may not be up to date on potential solutions.

There are options. The first step is to seek an assessment that can help you identify if your have a circadian rhythm sleep disorder. If you can find a doctor with a sleep specialization, she may recommend light therapy, a sleep study (to ensure there are additional issues) or drugs. She will want you to seek information or coaching about improved sleep habits and sleep hygiene.

If you prefer to minimize pharmaceutical drugs, you’ll have to go beyond your doctor.  New dietary
supplement products for home self-care beyond Melatonin are coming onto the market show promise. For example, Loving Works, LLC just released the Sleep Balancer™, a liquid dietary supplement herbal sleeping aid that was formulated by Kyle D. Morgan, D.O..  The Sleep Balancer™ can help patients balance their circadian rhythms without side effects or habit-forming difficulties, even over the long-term. The product is
getting strong reviews by customers.

While ES and CRSD conditions are not well known, their symptoms affect millions of people daily. As people become more educated about their health and the movement towards a model of self-care grows, sleep
issues due to circadian rhythm sleep disorders will become the next big health issue that you should know about.

References

1    Culpepper, L., Wake Up to the Evidence on Sleep-Wake Issues: Is Circadian Misalignment the Cause?, Medscape Family Medicine Education, April, 2011

2    Ohayon MM, Vecchierini MF. Daytime sleepiness and cognitive impairment in the elderly population. Arch Intern Med. 2002;162:201-208.

3    Fernandez-Mendoza J, Calhoun S, Bixler EO, et al. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010;33:459-465.

4    Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2005;25:117-129.

5    O’Brien LM. The neurocognitive effects of sleep disruption in children and adolescents. Child Adolesc Psychiatr Clin N Am. 2009;18:813-823.

6    Drake C, Roehrs T, Breslau N, et al. The 10-year risk of verified motor vehicle crashes in relation to physiologic sleepiness. Sleep. 2010;33:745-752.

7     Robb G Sultana S, Ameratunga S, Jackson R. A systematic review of epidemiological studies investigating risk factors for work-related road traffic crashes and injuries. Inj Prev. 2008;14:51-58.

8    National Highway Transportation Safety Administration. Wake Up and Get Some Sleep. National Highway Traffic Safety Administration, ed. National Highway Traffic Safety Administration. http://www.nhtsa.dot.gov/people/injury/drowsy_driving1/human/drows_driving/fbroch/fbroch.html

9    AAA Foundation for Traffic Safety. FAQs: Drowsy Driving.
http://www.aaafts.org/resources/index.cfm?button=drowsyfaq.

10  National Sleep Foundation. 2005 Adult Sleep Habits and Styles. http://www.sleepfoundation.org/article/sleepamerica-polls/2005-adult-sleep-habits-and-styles.

11   Pagel JF. Excessive daytime sleepiness. Am Fam Physician. 2009;79:391-396.

12  Schwartz JR, Roth T, Hirshkowitz M, Wright KP. Recognition and management of excessive sleepiness in the primary care setting. Prim Care Companion J Clin Psychiatry. 2009;11:197-204.

13  Stroe AF, Roth T, Jefferson C, et al. Comparative levels of excessive daytime sleepiness in common medical disorders. Sleep Med. 2010;11:890-896.

14  Feng J, He QY, Zhang XL, et al. Epworth Sleepiness Scale may be an indicator for blood pressure profile and prevalence of coronary artery disease and cerebrovascular disease in patients with obstructive sleep apnea. Sleep Breath. 2011 Jan 19.

15  Goldstein IB, Ancoli-Israel S, Shapiro D. Relationship between daytime sleepiness and blood pressure in healthy older adults. Am J Hypertens. 2004;17:787-792.

16 Whitney CW, Enright PL, Newman AB, et al. Correlates of daytime sleepiness in 4578 elderly persons: the Cardiovascular Health Study. Sleep. 1998;21:27-36.

17     Laino, C., Sleep Deprivation Linked to Weight Gain, American Thoracic Society International Conference, May 2006

18   Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65(Suppl 16):12-16

19  Kessler, R., et. al, Insomnia and the Performance of US Workers: Results from the American Insomnia Survey, Sleep. 2011; 34/09

20 Mold JW, Quattelbaum C, Schinnerer E, et al. Identification by primary care clinicians of patients with obstructive sleep apnea: a practice-based research network (PBRN) study. J Am Board Fam Med. 2011;24:138-145

21 Alattar M, Harrington JJ, Mitchell CM, Sloane P. Sleep problems in primary care: a North Carolina Family Practice Research Network (NC-FP-RN) study. J Am Board Fam Med. 2007;20:365-374.

22 Zuber,A., Is Insomnia a Disease? J Medical Watch Aug 11

23 Melatonin, Univ of Maryland, Medical Reference, Complementary Medicine, Aug 2011

What transforms you to a new life?

What makes you want to shout from the rooftops to tell everyone?

• Actress Jennifer Hudson, who has dropped 80 lbs, tells it. “I’m prouder of my weight loss than my Oscar!…I hope it has inspired people,” she said in her August Self magazine interview.

• Weight Balancing System achiever Beth Brooks of Berrien Springs, MI reveals it. “After 4 months, I dropped 48 lbs and 51 inches!  I’m finally happy with myself as I had lost 50 lbs before but put it all back on. I was very disappointed with myself about that as I just kept eating and drinking even though I couldn’t stand it. I now want to live a healthy life and help others achieve their goals,” she said.

• Commenting on Beth’s achievement, WBS achiever Michele Tucker-Homan, also of Berrien Springs, MI shouts it. “Wow!  You look incredible!  You’ve got to feel sooo good, I know I do! …I want to tell EVERYONE!!!!” she exclaimed.  Michele recently released 38 lbs and 36 inches in the past 2-1/2 months.

What is it about dropping significant weight that so personally empowers you to just feel so good?

Can it be feeling healthier? Certainly that’s part of it. Creaky knees, hip pain, uncomfortable sleeping, toxic sluggishness from being unable to move easily — improvements here can certainly cause you to feel so much better physically. But empowered? I don’t think so.

It must be from the accomplishment. When you drop significant weight and keep it off, it says something about you. It says you are determined. It reveals a mental discipline and ability to make a serious change that is very difficult for most people.  Yet you were able to do it, especially if you’ve carried significant weight for years and were able to drop it relatively quickly.

Such achievement and the traits that underscore it are admired. Others are impressed and appreciate you more when you show you have the wherewithal, the gumption, the drive and the grit to see it through a difficult challenge and reach a big goal. In addition, social science research reveals that when you do something that you say you are going to do, you become more predictable. And that predictability is a key part of building trust.

Thus when you achieve significant weight loss, you are also seen as more trustworthy.

In the end, although the admiration feels great, the payoff is more personal. The feelings of empowerment arise from the inside, from knowing of your found inner strength and ability.

We’ve heard from so many people who described how carrying significant extra weight was more than just a physical burden. It weighed on their self-esteem and self-worth. They reported feeling so fed up, so unhappy, so bad about themselves that it led to many other problems. The mental/emotional weight was often more difficult than any physical impact to their health. And for some, it led constant anxiety and unhappiness and even emotional breakdowns.  Such feelings blocked them in many other areas of life as well.

So when you achieve significant weight loss and can keep it off, the internal energy of knowing your strength and ability spills over into other areas. We’ve seen personal transformations continue beyond weight and size reduction and the new wardrobes it often brings.  The shifts have been as simple as changing one’s hair to a more youthful and attractive cut or beginning a regular exercise regimen to something more significant such as leading family members to greater health, volunteering significant time to help others or replacing a deadend job with a more desirable opportunity.

Such a change on the inside is so positive and fulfilling, that you want to shout it out and share it with the world. You want to create a positive impact to others and spread that inspirational energy. You have the knowledge, the strength and the personal power to work towards other important goals in your life. It is easier to believe, in yourself, and with that belief, accomplish more of what it is that makes living so worthwhile.

You will likely never be recognized with an Oscar. But you have the potential to achieve something surprisingly better– dropping significant weight.

And that is truly transformational.

You may not have heard of the massive sleep study from researchers at Case Western University of Ohio, published in 2002.

From 1986-2002,  researchers tracked nearly 70,000 women aged 40-60. Researchers checked sleeping habits, weight and other data every 2 years. The conclusions? Women who slept 5 hours or less per night weighed on average 5.5 lbs more than women who slept at least 7 hours per night.

While this may not sound like much, put another way, sleeping 5 hours or less per night increased by 33% that a women would add 33 lbs and by 16% that she would become obese over this period.

For long-term weight management, getting at least 7 hours of quality sleep is critically important to staying slim.

Further research published in 2010 in the Annals of Internal Medicine revealed that sufficient sleep combined with diet could more than double the amount of fat released on a similar diet. The researchers from the University of Chicago’s General Clinical Resource Center studied 10 overweight but otherwise healthy volunteers aged 35 to 49.  Participants were placed on an individualized, balanced diet, with calories restricted to 90 percent of what each person needed to maintain his or her weight without exercise (1450 calories/day). Participants were tracked for 2 weeks during which they slept at the research facility on average 7.2 hours per night. During a second 2-week period, the same participants slept on average 5.5 hours per night.

According to the researchers, when dieters in the study slept on average 7.2 hours/night, they lost the same amount of average weight as when they slept 5.5 hours. Yet when dieters got more sleep, more than half of the weight they lost was fat. When they cut back on their sleep, only one-fourth of their weight loss came from fat.

Participants also felt hungrier when they slept less. When sleep was restricted, dieters produced higher levels of ghrelin, a hormone that triggers hunger and reduces energy expenditure.

“The message for people trying to lose weight is clear,” states study director Plamen Penev, MD, PhD, assistant professor of medicine at the University of Chicago. “For the first time, we have evidence that the amount of sleep makes a big difference on the results of dietary interventions. One should not ignore the way they sleep when going on a diet. Obtaining adequate sleep may enhance the beneficial effects of a diet. Not getting enough sleep could defeat the desired effects.”*

*source: http://www.sciencedaily.com/releases/2010/10/101004211637.htm

So getting at least 7 hours of sleep per night can help you to sleep your belly fat away when on an effective dietary program. Wow! Fantastic news.

Good thing we’ve just launched the Sleep Balancer(tm)– an all-natural liquid dietary supplement that can help you to improve your sleep and better align to your circadian rhythms. This new product can combine with the Weight Balancing System to help you drop more belly fat, especially as you sleep.

Contact support@myLovingWorks.com for more details.

But he survived. Of course, with a brain injury, the mind works differently. So does the speech. And so does the walking with a cane.

Yet the spirit was not touched. The strength and desire to persevere, the will to live, that strength continued.

Life can change in an instant into something unimaginable. Yet it is that strength of spirit, of the will to keep going, that distinguishes some of us from the rest of us, especially when confronted with the unthinkable. For David P., life could have meant giving up. But it hasn’t.

Sure, people look at him differently now. They glance at the cane and the irregular gait. They sometimes get impatient with how he talks and what he talks about and quietly excuse themselves. It can be uncomfortable for the fully abled to be around someone who doesn’t match their own patterns of speed, processing and image– if they let it.

David P. incredibly talks about how he was actually thankful for that bullet. He didn’t like himself,  that other guy, very well. That other guy’s choices in life weren’t great. That guy didn’t treat people well. His goals were misdirected.

Now things are different. David’s working to finish his social work degree at Eastern Michigan University, achieving a 3.5 GPA that he’s quite proud of. He takes each day as it comes. The things that used to get to him no longer have that power over him. He feels that if you have a passion for something, you can accomplish anything.He likes who he has become.

And when he saw he had put on quite a bit of weight, he set about to release it. This isn’t a story about the Weight Balancing System, although that’s what he used to drop 50 lbs in 5 months. It’s about reconnecting with what a person wants to be and to become, even under extreme circumstance and challenge.

It took some effort, yes. It took him longer than most. That’s how his days go. Things do take longer. But like the story of the Tortoise and the Hare, he accomplished his goal and has kept his weight off for months, unlike others who don’t even try.

“I sometimes wonder what their excuse is,” he said to me a while back. “They don’t have the same challenges as me. But they aren’t interested in dropping some weight and feeling better. I don’t get it.”

Could you lose 50 lbs after a bullet to the brain?

I like to think that I could.

No it doesn’t mean being “present,” although that may have something to do with it. According to Dictionary.com, prescient is of or relating to “prescience.”

And Prescience is having knowledge of events before they take place; foreknowledge

I also checked  -TheFreeDictionary.com and found:

Prescience is perceiving the significance of events before they occur; or having or revealing keen insight and good judgment;

I loved being prescient about the “One Weird Tip” ads. In my last blog on June 25th, I wrote about how we were all being weird by clicking on these crazy “One Weird Tip” ads that show up everywhere.

Then on July 9th, the Washington Post reported that the FTC was suing numerous companies on their diet scams using– here it comes– the One Weird Tip ads. The Washington Post reported that there were millions of people who had clicked on that link which sent them to a fake news reporter web page, offering free weight loss products that were anything BUT free. (See http://mlw.mylovingworks.com/forum/content.php?142-FTC-Calls-Out-1-Weird-Trick-Tiny-Belly-Online-Ads-as-Part-of-Major-Weight-Loss-Scam)

Huge diet scam.

Millions of people.

So I enjoyed the inner feeling of being prescient for a moment. Those frickin’ scammers ripping people off were finally getting theirs! We won’t be seeing those “One Weird Tip” ads anymore. The regulators finally stepped in and took action after thousands of complaints.

Then I noticed on border of the TheFreeDictionary.com page a familiar dynamic .gif ad of a flabby belly going from fat to thin but with a different title:

“4 Foods to Never Eat” and the tag line: Cut down a bit of your belly fat each day by never eating these four foods.” Click here to get the “tip.”

I suppose the Trick is on us.

It’s everywhere.

One weird trick to lose belly fat…

One weird trick to stay asleep at night…

One weird trick to doing exercise…

A mom’s simple trick to whiten teeth…

Obey this one weird diet trick…

Why?

Because you keep clicking on that link, that’s why!

Quit it.

There is nothing weird about it, other than you clicking on the link. And getting spammed, loaded with viruses and stored as another member of Barnum’s great population of the unwashed.

Stop it. Stop clicking and the “one weird trick”  will go away.

Want to lose belly fat? Reduce your portion sizes and eat healthy low-fat protein, fresh veggies and fruits with plenty of daily water intake, 7 hours of sleep and stress reducing activities. Cut out the sugar and simple carbs and the beer and bread and ice cream. Use the Weight Balancing System or other weight loss program that helps you get results and stay motivated. Have a dieting buddy for support. Increase your exercise…alot.

Want to get to sleep and stay asleep at night? Go to bed at a regular time, avoid eating anything 2-3 hours before bedtime or drinking 12 oz of water right before bedtime, have comfortable bed and bedding with a good pillow, work out/exercise or do some other stress reducing activities, explore our new Sleep Balancer or other natural sleep aids. Don’t have a TV in your bedroom.

Want to start exercising? Put it on your calendar and in your scheduler. Set an alarm. Find something that is fun. It can be outdoors and doesn’t have to be in a gym or a cardio machine. Get an exercise buddy.

Want to whiten your teeth? Stop smoking. Cut back on drinking teas. See your dentist. Why is it that you want to whiten your teeth?

Want to obey? Contact me later about that one…

Want to stop being weird? Quit clicking on the spammers “one weird trick…” links and we’ll all sleep better at night.

At the largest chiropractic show in the US– this past January 2011′s Parker Convention in Las Vegas– Loving Works released an article that predicted the FDA would take action on homeopathic hCG because it was illegal. (We later published a shortened version of that article in the April edition of the Journal of the Michigan Chiropractic Association (http://www.chiromi.com/)).

Two weeks later, in a January 23, 2011 article in the online USATODAY,  the FDA stated homeopathic hCG was illegal. (See link: http://www.usatoday.com/yourlife/fitness/weight-loss-challenge/2011-01-24-hcgdiet24_ST_N.htm)

Why? Homeopathic hCG is a misbranded and adulterated substance because the active ingredient– human chorionic gonadotropin (hCG)– is a pharmaceutical drug approved in 1972 for fertility treatments.

According to FDA Compliance Policy Guide 400.400, in order to market a homeopathic product that has a pharmaceutical active ingredient, there must either be an monograph that is approved by the Homeopathic Pharmacopeia of the US (HPUS) or a manufacturer’s finding that validates the efficacy of the pharmaceutical ingredient as a homeopathic ingredient. (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm)
There is no monograph in the HPUS for homeopathic hCG.

There are no approved, published manufacturer’s findings for homeopathic hCG.

Hence every manufacturer and every seller of homeopathic hCG is selling a misbranded drug.

There have been many articles and newscasts–including a full show on hCG by Dr. Oz– that mentioned the controversy, but somehow the producers or writers failed to report the key phrase: ILLEGAL.

Seems strange that even Dr. Oz would miss this on his program.

This will change soon.

From our sources, we know that the FDA is collecting data on the side effects of using homeopathic hCG as a weight loss application.  Because there are side effects. Look at any weight loss forum or any Facebook hCG product page.  Even though the January 2011 article stated that the FDA was not currently enforcing the law on homeopathic hCG, they will be.

And soon.

We predict FDA regulations prohibiting the sale of homeopathic hCG will be enforced in the next 6 to 18 months.

Big time.

Certain people will be selected  and their businesses will be shut down. Selected chiropractors selling the product will have their practices raided, computers confiscated and homeopathic hCG products seized. Licenses to practice chiropractic will be up for penalties or suspension. Chiropractors who lose their livelihoods may have grounds to sue the manufacturers and wholesalers who sold them illegal products that they either knew beforehand were illegal and sold it anyway or didn’t know and but were still responsible.

We have documentation of a current major homeopathic hCG manufacturer who knows all of this and sells the stuff anyway. He is on record of secretly telling his prized customers that the…

“…Worse scenario as we see it we just take HCG out of the formula and off the label and you have a relatively seamless marketing and sales adjustment. Those selling HCG without Official HPUS ingredients to substantiate their claims get the rug pulled out from underneath them. Now the competing products are gone and you are left with the market in your hands as the go to practitioner!”

How can they take the hCG out of the homeopathic product and still be able to follow the Simeons protocol? They can’t without admitting that hCG is not a necessary ingredient to achieve the weight loss.

Does this not support the MD’s, the health websites, the experts who say that hCG does nothing to help people lose weight other than a placebo effect?

We know of another top hCG manufacturer that has already done just that. They no longer offer their homeopathic hCG that they have sold in the tens of thousands but instead have launched a new product that has numerous amino acids, changes the Simeons protocol (which was very strict and explicitly called for injectible hCG) but still says it’s the Simeon’s protocol. And so they have already made the great leap.

I don’t blame them. They are capitalists, interested in making money. They rode the hCG horse and now see it’s time is ending. Time to ride the new horse– the hCG protocol without hCG.

There’s a slight problem as I see it. How can someone with integrity and a straight face sell you homeopathic hCG today, raving about its efficacy and effectiveness with the Simeons protocol and the next day tell you  that you don’t need the hCG ingredient or don’t have to follow the strict requirements of the Simeons protocol? It’s totally contradictory!

Should we be surprised about this insidious attitude of those who will “…hold their nose while they take your money…” as a chiropractor mentioned to me recently?

Nope.

But you might be surprised, you the buying public. Even though tens of thousands, if not many more, users of homeopathic hCG were able to drop significant weight, it may cause you to question where you’re spending your hard-earned dollars.

Yet there will likely be a different outcry when the FDA shuts down homeopathic hCG. The average Joe and Jane who had results will complain: ”Those FDA people are all trying to help the Big Pharma companies make more money.”

While there may be many questionable goings-on at FDA, the revolving door between industry and regulators of industry swapping seats as consultants and administrators, of who gets to speak and who doesn’t, etc., etc., the upcoming purge of illegal homeopathic hCG is simply law enforcement. FDA announced in December 2010 that they were targeting body building (human growth hormone, steroids), Erectile Dysfunction (ED) and weight loss for misbranded and adulterated products, in order to protect the public from unscrupulous sellers (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm).

What is surprising is how many unscrupulous sellers who make and sell homeopathic hCG today consider themselves good people, who want to do right and just make a living, to make some decent money (or a huge amount of it). If you mention that they are crooks, that they are pushers selling an illegal drug, they give excuses or argue about it, calling such claims fear based or scare tactics.

For example, one manufacturer said that the illegality of homeopathic hCG was “…in a grey area.” Yet he knows clearly it’s black and white!

What’s strange is these same people wouldn’t think of selling homeopathic cocaine because it’s obviously illegal– even though it DOES have a HPUS monograph. Because even though homeopathic cocaine is homeopathic, it still requires a prescription from a licensed health care provider (for use as a treatment for mountain sickness). Why? It’s a Schedule II controlled substance. Just like hCG is a controlled substance too– a Schedule III controlled substance listed in 22 states. Both require a prescription to be obtained properly.

So it’s predictable. Homeopathic hCG will be shut down. Just like hCG was shut down in 1975 after growing quickly in the early 1970′s to become the largest selling weight loss program in the US.

So does hCG really work you may ask?

From 1958 to 1977, 15 of 16 double-blind, placebo based controlled studies revealed hCG is not statistically significant, meaning it’s no better than a placebo. Most health organizations says it’s bunk, even  a fraud. The FDA says hCG is health fraud and homeopathic hCG is both health fraud and an illegal, misbranded product.

Yet tens of thousands of successful users disagree. And so does the IAPAM (International Association for Physicians in Aesthetic Medicine ), which is on record saying not only does hCG work, but they have a training program for their members. Hundreds of MD’s have been trained to prescribe hCG off-label for their weight loss patients. As medical doctors, they can legally prescribed hCG for off-label use (as long as they meet FDA/FTC requirements established in 1975).  Tens of thousands of hCG users swear by it.

Heck, we at Loving Works are on record as saying hCG is a viable weight loss regimen. We just insist on reminding users that they should follow the law and stop buying illegal homeopathic hCG, which is an illegal drug. Get it legally from a licensed health care provider. That it costs $300- $1000 via a doctor’s prescription rather than $20-$125 on the internet is too bad. It’s a drug. Pay the price instead of buying illegal.

It’s that simple.

Or if you want a better alternative, contact us. 70% of people who use the Weight Balancing System (WBS) and hCG prefer the WBS over hCG. Check out http://mlw.mylovingworks.com/forum to find out more.

It truly is that simple to see that homeopathic hCG will soon be on its way out.