--- On Sun, 6/29/08, Bottom Line Secrets <BottomLineSecrets@bls.bottomlinesecrets.com> wrote:
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Monday, June 30, 2008
Fw: Safety Alert on Generic Drugs
eneric drugs cost 30% to 80% less than their brand-name counterparts and most people feel safe taking them because the FDA requires that both types of medications provide the same active ingredients and level of effectiveness. 
Periodic checks for impurities. The FDA monitors generic drugs, testing for such things as proper dosing and active ingredients. But the agency only checks about 300 "dosage forms," such as tablets and capsules, among brand-name and generic products a year -- out of a total of more than three billion prescriptions.
Monday, June 23, 2008
Murder by the Numbers: the Codex Agenda
You know it as well as I do: the main threat to our health and health freedom is that we are so very productive, financially speaking, when we are sick. Healthy, we work and go to school and pay taxes and get married and so forth. Health is, after all, our natural state of being but it does not generate much income for the illness industry.
Sick, we have the capacity to pour nearly limitless streams of wealth into the coffers of the vast industry that prospers only if we are ill. The huge hospitals, the ubiquitous drug stores, the nurses and doctors, the cancer and cardiovascular centers, the sleek and slick drug companies - where would they be if we were well? Nonexistent-- that's where they would be.
If illness were not so profitable, we would not have to fight so hard for our health. It would not be in anyone's best interests to have us sicker younger, longer. If our illness were not the most financially productive reality on Planet Earth, we would use herbs, nutrients, exercise, sunlight, mind/body techniques and other inexpensive, powerful and non toxic health strategies as a matter of course. There would be no battle for our minds and our bodies to degrade our immune systems and force us into lingering, tragic diseases which are so very profitable for the illness industry - and devastating for us.
I have said it before and I will say it again: the other side has more money than God. They will use it to make you sick and to make you believe that the only way to get well is to put your faith, your money and your health, in the hands of the agencies and industries that profit from your illness, not your wellness. These are the people who, like the FDA, are perfectly happy to jeopardize your health, indeed your very life, to keep their corporate masters happy by approving unsafe food and dangerous drugs while conducting a vigorous war on your well being and your right to use products, services and strategies which do not enhance illness, but support wellness.
Thursday, June 19, 2008
Cell Phone Hazards - The Evidence Is In
By William Thomas
The evidence is in - and it is overwhelming. Even at typical low power, cell phones and wireless technology cause severe biological disturbances in human cells. In August 2007, 26 medical and public health experts their Bioinitiative Report - available online - reviewing all the literature on the effects of electromagnetic radiation
Cell phone researchers not in the pay of mobile phone corporations agree on three things:
1. Current guidelines based only on the heating effects of cell phones do not address non-heating damage to DNA, nor the effects of frequency modulation used to broadcast information and are completely inadequate to safeguard public health. Specific Absorption Rate (SAR) is should not be used as a basis for a safety standard since it regulates against thermal effects only.
So far cell phone “safety codes” only regulate radiation capable of burning skin. It's like saying cigarettes aren't dangerous unless they burn you.
Cellphone manufactures insist that “many studies” show their miniature microwave ovens are safe. But when pressed by the Washington Post to back up their claim, the cellphone industry could cite no studies showing no adverse impact from cellular telephones on human tissues, nervous systems or organs.
Dr. George Carlo confirms: “The industry had come out and said that there were thousands of studies that proved that wireless phones are safe, and the fact was that there were no studies that were directly relevant.”
There are more than 15,000 scientific studies reporting the cell phone health hazards. At least 66 epidemiological studies show that electromagnetic radiation increases brain tumors in human populations. [“Cell Phone Convenience or 21st Century Plague?" by Dr. Nick Begich and James Roderick earthpulse.com]
A TWO-MINUTE CALL
After only two minutes of cellphone exposure, the blood-brain barrier fails, allowing proteins to enter the brain that can cause nerve damage. “Molecules such as proteins and toxins can pass out of the blood, while the phone is switched on, and enter the brain. We need to bear in mind diseases such as MS and Alzheimer's are linked to proteins being found in the brain.” So, adds Leif Salford of Lund University in Sweden, is Parkinson's disease. [Electronics Australia Magazine Feb/00]
STRESS PROTEINS
Cell phone and cell phone tower radiation stress our cells, releasing DNA-damaging free radicals and stress proteins that can migrate through the opened blood-brain barrier and cause degenerative damage in the brain. Dr. Theodore Litovitz, a biophysicist and professor emeritus of physics at Catholic University, explains: "Because stress proteins are involved in the progression of a number of diseases, heavy daily cell-phone usage could lead to great incidence of disorders such as Alzheimer's and cancer." [Reuters Apr 23/08; wirelessconsumers.org Dec03/01]
2. Children through teenage years, and pregnant women should be kept away from cell phones and cell phone radiation.
Alarmed British military scientists have discovered that every cell phone transmission disrupts brain functioning responsible for memory and learning. “Overuse” can cause forgetfulness and sudden confusion, as well as loss of the ability to concentrate, calculate and coordinate.
Children and teens who become hooked on cell phones face a lifetime of learning disabilities, hyperactivity, high risk from driving accidents, greatly increased acute and chronic asthma, hearing loss, vision loss, sleep disorders and cancers - as well as loss of social skills, inability to think and reason clearly, loss of contact with their surroundings. [India Tribune Sept 17/04]
More than 2 billion people - including at least 500 million children - are using cell phones.
At least 87% of 11- to 16-year-olds own cell phones. In the USA, one in three teenagers uses a cell phone. RF/MW signals currently under discussion for inflicting on wireless classrooms throughout North America and the overdeveloped world will operate in the 2.4 GHz frequency range - two to three times higher than current cell phones. Plans are already underway to boost classroom radiation levels with “upgraded” technology emitting 5 GHz. [Uncensored (NZ) Nov 9/06; irf.univie.ac.at]
These kids may be difficult to replace, because researchers at University of Szeged in Hungary have discovered that men carrying their cell phones on standby anywhere in their clothing throughout the day produce about a third less sperm than those who do not. Of the remaining sperm, high numbers were found to be swimming erratically - significantly reducing chances of fertilization. [BBC June 27/04]
Put men made infertile by their cell phones together with fashionable beach going women who carry their cellphones in their bikini bottoms and... We could be looking at an inadvertent cell phone cull. Especially if women are culled by bra-makers encouraging them to carry cell phones in their convenient, already cancer-prone cleavage.
The Spanish Neuro Diagnostic Research Institute in Marbella has found that a call lasting just two minutes can alter the natural electrical activity of a child's brain for up to an hour afterwards. Spanish doctors now fear that disturbed brain activity in children will lead to impaired learning ability, as well as psychiatric and behavioural problems.
Brain scans allowed Dr. Michael Klieeisen's team to see what is happening to the brains of cell phone users. “We never expected to see this continuing activity in the brain,” he told the European press in new stories blacked out in the U.S.
Dr. Gerald Hyland finds the results "extremely disturbing.” Parents who believe they are enhancing their children's safety and social standing by sending them back to school with cellphones could be impairing their health and ability to learn, Dr. Hyland warns. “The results show that children's brains are affected for long periods even after very short-term use. Their brain wave patterns are abnormal and stay like that for a long period. This could affect their mood and ability to learn in the classroom if they have been using a phone during break time, for instance.”
These same altered brain waves “could lead to things like a lack of concentration, memory loss, inability to learn and aggressive behaviour. My advice would be to avoid mobiles." [Mirror Dec 26/01]
Led by Sir William Stewart, the famous British biochemist and president of the British Association for the Advancement of Science biomedical specialists, the Stewart Inquiry report on “Mobile Phones and Health” was released in April 2000. Sir William said he would not allow his grandchildren to use mobile phones. [Journal of the Australasian College of Nutritional & Environmental Medicine Sept /01]
In Sweden cell phones are being marketed to 5-year-olds. Olle Johansson, Associate Professor of Neuroscience at the Karolinska Institute in Stockholm declares: “Parents should take their children away from that technology." [Dialing Our Cells by William Thomas]
The Australian government's Commonwealth Scientific and Industrial Research Organisation (CSIRO) described laboratory tests as far back December 1974 showing neurons in the soft skulls of developing fetuses are extremely sensitive to heat during the process of cell division. ”The mother's pelvic structure promotes deep RF radiation penetration within the developing embryo or fetus,” Dr. Barnett warned. The womb's saline fluid is also highly conductive to Radio Frequencies and microwaves - and the EMF-conductive human body is 65% water-by-weight. Brain functioning may be impaired for life. [CSIRO June 1994; irf.univie.ac.at/emf; EMFacts Consultancy Mar 26/03]
The age of cell phone users continues to drop as fast as their IQ and attention span. In 2007, the average age of first-time “users” was 10. By next year, International Data Corp forecasts the 9-and-under market will rack up an additional $1.6 billion in revenue for cell phone companies - and add another nine million child zombies in the United States alone.
According to a Eurobarometer survey of children in 29 countries, most had cellphones after age 9. "We're pretty bullish on increased usage by teenagers,” exudes Adam Guy, a senior analyst at the Strategist Group. “Usage penetration is exploding."
Four in 10 people, particularly young adults, make cell phone calls to kill time as well as themselves. [London Telegraph Oct 9/07]
Professor Mild, of Orbero University, Sweden is a Government adviser who led the research says children should not be allowed to use mobile phones. He and others want a revision of the emission standard for mobiles and other sources of radiation, which they describe as “inappropriate” and “not safe”. [London Telegraph Oct 9/07]
Dr. Salford says brain neurons that would normally not become senile until people reached their 60's, are doing so now when people reach their 30's because of cell phone exposure. [ RFSafe.com Nov26/03]
Cellular One's slogan - "Wherever you go, there we are" - takes on ominous overtones as uninformed people are buying cellphones worldwide at the rate of 25 thousand a day and succumb to PR campaigns like the one that shows a picture of a crib and bears the legend: "No Member of the Family Should Be Without One..." [Independent Mar 30/08]
BEYOND CANCER
It's not just cancer that makes cell phones so dangerous. Lloyd's of London refuses to insure phone manufacturers against the risk of subscribers developing cancer - and early onset Alzheimer's. [Observer Mar11/99]
“Cumulative DNA damage in nerve cells of the brain can lead to Alzheimer's, Huntington's, and Parkinson's diseases.” One type of brain cell can become cancerous from these double-strand DNA breaks at lower than the current Specific Absorption Rate exposure-standard (4 watts/kg).
It is not the total energy associated with the EMF that is critical, but rather pulsed oscillations.
Many repetitions at the higher frequency close to subtle natural rhythms cause non-thermal threshold to be reached in a shorter time. This makes cellular processes “unusually sensitive to non-thermal ELF frequency fields.”
Dr. Henry Lai, a 20-year EMF researcher, and colleague Dr. N.P. Singh confirmed double-strand DNA breaks in test animals exposed for just two hours to pulsed, cell phone microwaves.
When you talk on your mobile phone at 800 MHz and 1,990 MHz, whipping anything back-and-forth 800 or 1,990 million times per second is bound to cause breakage in the double-strand DNA of human cells. [guardian.co.uk]
EM engineer Alasdair Philips of Britain's Powerwatch looked for people under age 40 using cell phones more than four hours a day, and found them already retired as “unfit for future work” due to early onset dementia. [EMFacts Consultancy Mar 26/03]
3. The risk of contracting cancer from cell phones is about 4% of more than 2 billion users - 80 million people and rising at 25,000 new "users" every day. The risk of premature senility and contracting Alzheimer's is extreme. Most kids brought up using cell phones will be functionally senile by the time they are 30.
You only need 2000 hours on a cell - OR A CORDLESS - phone to qualify for a 2 to 4x increased likelihood of a brain (glioma) or ear (acoustic neuroma) tumor.
On a New Zealand news show, Dr. George Carlo called marketing strategies aimed at children, “grotesque” after identifying as many as 50,000 new cases of brain and eye cancer attributable to cell phone use being diagnosed every year. (Mobile users who wear metal-frame glasses intensify the exposure to their eyes and heads). Based on current epidemiological studies, that number will reach half a million cell phone cancer cases annually within the next two years. [IsraCast Technology News July 29/05]
After heading a $28 million cell phone study from 1993 through 2001, Dr. Carlos' finding “that RF causes genetic damage” was not welcomed by his cell phone industry sponsors. Ross Adey worked on similar research funded by Motorola in 1991. After he came to similar conclusions, Motorola was adamant that Adey never mention DNA damage and radiofrequency radiation in the same breath. [WSW July 11/02; wirelessconsumers.org Dec03/01]
DRIVE TIME
Stunned by an additional $4 billion a year in claims for drivers using cell phones, North American insurers discovered that juggling phones while driving is not causing a 600% increase in accidents. Cell phones are much worse than merely dangerous driving distractions. Tests conducted by the U.S. Department of Energy found that using a cellphone severely impairs a driver's memory and reaction times by disrupting signals to and within the brain. Hands-free mobile phones cause even more crashes because they typically emit 10-times more brainwave interference than handheld units.
Phoning from inside a car or truck is a bad call for everyone in the vehicle - especially children - because the surrounding steel structure amplifies cellphone emissions “by up to 10-fold,” the UK House of Commons Science and Technology Committee reports.
University of Toronto investigators report that the heightened probability of cracking up your car persists for up to a half-hour after completing a call.
“That's comparable to the risk of crashing while driving dead drunk,” exclaims Dr. Chris Runball, chairman of the B.C. Medical Association's emergency medical services committee. Motorists talking on cell phones are actually more impaired than drunk drivers with blood-alcohol levels exceeding 0.08. It doesn't matter whether the phone is hand-held or hands free. [Human Factors and Ergonomics Society]
If you put a 20-year-old driver behind the wheel with a cell phone, her reaction times are the same as a 70-year-old driver. But not as wise. [AP Feb 2/05; Human Factors Winter/05]
ELECTRICAL FIELDS AND MAGNETIC FIELDS
“The electricity that comes out of every power socket has associated low frequency electromagnetic fields. Various kinds of higher frequency radiowaves are used to transmit information - whether via TV antennas, radio stations or mobile phone base stations.”
“Radio, television, radar and cellular telephone antennas, and microwave ovens are the main sources of RF fields. These fields induce currents within the human body, which if sufficient can produce a range of effects.”
“A magnetic field is only produced once a device is switched on and current flows.”
Magnetic fields penetrate living tissue “easily.”
“Magnetic fields as low as around 2 milligauss or a millionth of a Tesla can produce biological effects. Using a cell phone or a PDA exposes you to magnetic pulses that peak at several tens of microtesla, which is well over the minimum needed to give harmful effects.” [Bioeffects Initiative report]
CHILDHOOD LEUKEMIA
“Childhood leukemia is the most frequent childhood malignancy that peaks in the age group of 2 to about 5 years… This peak seems to have been newly evolved in the early quarter of the 20th century and may be due to electrification”… acting as synergistic activators of toxic chemical compounds, I add to the Bioeffects Initiative finding.
MELATONIN, ALZHEIMER'S AND BREAST CANCER
“Melatonin is found in nearly all organisms… it helps prevent both Alzheimer's disease and breast cancer. Long-term exposure to extremely low frequency (ELF, = 60 Hz) magnetic fields is associated with a decrease in melatonin production.”
“Amyloid beta protein is generally considered the primary neurotoxic agent causally associated with Alzheimer's disease. Melatonin can inhibit the development of Alzheimer's disease and, thus, low melatonin may increase the risk of Alzheimer's disease.
“Low melatonin production is a likely risk factor for breast cancer… 11 of the 13 published epidemiologic residential and occupational studies are considered to provide (positive) evidence that high MF exposure can result in decreased melatonin production. (The two negative studies had important deficiencies that may certainly have biased the results.)”
“Some modulation patterns are more bioactive than others, for example, frequencies are similar to those found in brain wave patterns. Current public safety limits do not take modulation into account and thus are no longer sufficiently protective of public health where chronic exposure to pulsed or pulse-modulated signal is involved, and where sub-populations of more susceptible individuals may be at risk from such exposures.” [Bioeffects Initiative report]
LOW POWER IS VERY DANGEROUS
Cell phone researcher Dr. Peter Franch says unequivocally that brain and other “cells are permanently damaged by cellular phone frequencies.” This cellular damage, Franch notes, is maximized at low power. [guardian.co.uk]
Much like taking repeated blows to the head, rapidly pulsing cell phones signal permanent brain damage. And the high frequency range used in today's digital cell phones is also very close to the resonant frequency of human DNA, as well as the resonant frequency of the human skull case.
As the Bioeffects Initiative report points out: “Published laboratory studies have provided evidence for more than 40 years on bioeffects at much lower intensities than cited in the various widely publicized guidelines for limits to prevent harmful effects. Many of these reports show EMF-caused changes in processes associated with cell growth control, differentiation and proliferation which are the molecular and cellular basis of cancer.”
“Windows of intensity align across different carrier frequencies." [Bioeffects Initiative report]
COLTAN
A tiny piece of mineral used in your phone called coltan is causing a frenzied rush for its extraction in strip mines across the Congo - exploiting children, razing pristine forests, wiping out up to 90% of all mountain gorillas, and has already led to the rape of more than 250,000 women as old as 75 and girls as young as three.
Since consumers don't have any idea where the coltan in their phones comes from, please stop buying them until guidelines guaranteeing the provenance of cell phone and wireless laptop computers come in.
CONCLUSIONS OF THE BIOEFFECTS INITIATIVE REPORT
“The conclusion that, if health effects of commonly encountered RF exposures exist, they must be small, is wrong. The evidence points to a quite substantial hazard. Scientific research has shown that the public is not being protected from potential damage that can be caused by exposure to EMF, both power frequency (ELF) and radio frequency (RF).”
“There is a need for a biological standard to replace the thermal standard and to also protect against cumulative effects across the EM spectrum.”
One main conclusion from the worldwide NATO meetings in 2005: “Worldwide harmonization of standards have to be based on biological responses.”
“DNA damage (strand breaks), a cause of cancer, occurs at levels of ELF and RF that are below the safety limits. Also, there is no protection against cumulative effects stimulated by different parts of the EM spectrum.”
“ELF limits for public exposure should be revised to reflect increased risk of breast cancer at environmental levels possibly as low as 2 milliGauss or 3 mG.”
“There is substantial scientific evidence that some modulated fields (pulsed or repeated signals) are bioactive, which increases the likelihood that they could have health impacts with chronic exposure even at very low exposure levels. Modulation signals may interfere with normal, nonlinear biological processes.”
“Current standards have ignored modulation as a factor in human health impacts, and thus are inadequate in the protection of the public in terms of chronic exposure to some forms of ELFmodulated RF signals… The collective papers on modulation appear to be omitted from consideration.”
IT'S NOT JUST THE CELL PHONES!
What about all these cell phone relay towers springing up everywhere?
Our bodies - and each one of our trillions of cells - are exquisitely sensitive receiving antennas.
There are currently over 210,000 cell towers, providing 81% wireless penetration in America alone, and one would be hard-pressed to find an inhabitable place on Earth that is not within range of cell frequency transmissions. [CTIA The Wireless Association June/07]
The work of researchers like Dr. Henry Lai, Dr. Ross Adey and Dr. Jerry Phillips show that such effects as DNA strand breaks are produced not only by short-term exposure at high intensity, but also by long-term, chronic exposure to low intensities - like that increasingly experienced by growing numbers of people from cell phone towers and microwave communication facilities.
Henry Lai found Radio Frequency Radiation like that from cell phone towers penetrates further into a child's small, growing skull.
As my friend Chris Anderson points out, “This is continuous exposure, and it is not optional.”
Sydney Australia first city to go wireless say a significant jump in allergies and deaths.
By 2005, more than 500 cell tower disputes around the country ended up in court. But federal law prohibits towns from rejecting a transmission tower on the grounds that it poses health concerns. [New York Times May 1/05]
Now, cell phones small enough to fit inside a cigarette case have decreased reception so base stations must boost their microwave transmissions 15% to 20%. [New York Times Mar 10/03]
Findings by the Associated Bioelectromagnetics Technologists show that RF exposure from cell phones and cell phone relay towers “is wholly correlated with the repeatedly documented increased incidence of autism - now reported by at least some researchers as greater than 1 per 100 newborn.”
A COMING CULL?
Professor Khurana has placed his considerable reputation behind warning: “Unless the industry and governments take immediate and decisive steps, the incidence of malignant brain tumours and associated death rate will be observed to rise globally within a decade from now - by which time it may be much too late to medically intervene.” [Independent Mar 30/08]
“Dr. George Carlo predicts surefire disaster, and the complete destruction of the health care system from electromagnetic radiation alone.” Right now, the Bioeffects Initiative report indicates that as many as one in 10 people suffer debilitating effects from electromagnetic sensitivities. EMR expert Chris Anderson predicts, “In the next 5 to 10 years, fully half the developed world's population could suffer disability from EMR. [Chris Anderson EMR expert - correspondence with the author.)
After carefully reviewing more than 100 clinical studies showing that using “hands free” and regular cell phones for 10 years or more can double the risk of brain cancer, PhD Vini Khurana - who has received 14 awards while publishing more than three dozen scientific papers - predicts that cell phones will kill far more people than either smoking or asbestos. Smoking continues to cull some five million people worldwide every year, while asbestos exposure in England continues to claim as many corpses as road accidents. [Independent Mar 30/08]
In September 2007, the EU's European Environment Agency (EEA) and the country of Germany both issued warnings to their citizens advising them to avoid the use of WiFi and cell phones until further long term studies are conducted, citing fears that the ubiquitous use of wireless technology has the potential to become the next public health disaster on the level of tobacco smoking, asbestos, and lead in automobile gas. [naturalnews.com]
Dr. Vini Khurana urges everyone to stop using cell phones immediately. [Independent Mar 30/08]
GUARANTEED CELL PHONE PROTECTION
Dr. Gro Harlem Brundtland, director general of the World Health Organisation, former Norwegian prime minister and licensed physician emphasized: Making shorter calls does not help, [Microwave News Mar-Apr/02; Dagbladet Norge Mar 9/02]
The only way to ensure complete protection against being turned into a zombie by cell phones is to avoid using them except in emergencies when no other voice communication is available - at the max, experts suggest, one or two minutes per month.
SEVEN THINGS YOU CAN DO
1. Do not use a cell phone for longer than one minute twice a month.
2. Do not live within two miles or five kilometers from a cell phone tower. Get the tower removed. Or move.
3. In your home, unplug all electrical appliances when not in use. (Switching TVs and similar devices “off” does not turn them off. Intersecting electrical fields result.)
4. Avoid using wireless routers and portable phones.
5. Keep your bedroom free of electrical appliances, especially near your head while you sleep. Use a battery-operated alarm clock - never a plug-in clock radio! Unplug lamps when not in use.
6. Replace dimmer switches with regular switches to eliminate high-frequency radiation - the "dirty electricity" hidden in your home's most likely improperly grounded electrical wiring. (Even if done to Code.)
7. Take the best quality daily vitamin and mineral supplements program you can get your hands on.
slashphone.com
Bush's brain - stream .paranode.com
Unlucky cellphone winner - www.mala.ca
Tuesday, June 17, 2008
Vista: Restore the Hibernate Option - Tech-Recipes.com
1. Click the Start button.
2. Select All Programs.
3. Select Accessories.
4. Right-click on Command Prompt.
5. Select Run as Administrator.
6. When the UAC prompt appears, click Continue.
7. Type powercfg /hibernate on and press Enter on your keyboard.
8. Close the Command Prompt window.
9. Reboot your PC."
Monday, June 16, 2008
Diet Soft Drinks Contribute to Heart Disease Risk
eric has sent you this link to the following article
which appears on the Bottom Line Secrets Web site:
Diet Soft Drinks Contribute to Heart Disease Risk http://www.bottomlinesecrets.com/blpnet/article.html?article_id=45544
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Tuesday, June 10, 2008
GlaxoSmithKline Petitions the FDA
GlaxoSmithKline Petitions the FDA
Date: 6/9/2008
Posted By: Jon Barron
On April 17th, GlaxoSmithKline, along with three organizations that it financially supports (funny how that works), the American Dietetic Association, The Obesity Society, and Shaping America's Health, submitted a citizen petition to the Food and Drug Administration asking them to prohibit weight-loss structure/function claims associated with any dietary supplements that promote a connection with weight loss unless those supplements were pre-approved by the FDA. This ban would apply to all product labels, websites, literature, and any marketing material. But the petition didn't stop there. It seems that not only did GSK want to prevent nutrition companies from stating that their product could help with weight loss, the petition also asked the FDA to prohibit claims for energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption. What impact would this petition have if approved? Quite simply, if you cannot understand how a nutritional product can help you because no one is allowed to tell you what the product does, then why would you buy it? Instead, you would be "forced" to buy the pharmaceutical version that very clearly states that it helps with weight loss, while less clearly listing the side effects...in much smaller print. If approved, in a single stroke, all natural alternatives to weight loss would be eliminated from the market. As an interesting side note, it should be mentioned that the organizations' signatories included a lobbyist, a person who helped get obesity classified as a disease, and a fundraising guru. Although unlikely to be approved at this time, it represents frightening upping of the ante in the conflict between traditional medicine and alternative health care.
Back in 2003, I wrote a newsletter entitled, " Don't Look at the Pinstripes." Of all the newsletters I've ever written, it's one of my personal favorites. It's also one of the least understood. The basic theme of the newsletter was borrowed from the Steven Spielberg film, Catch Me If You Can, in which one of the characters says that the New York Yankees won all their pennants not because they had better players, but because their opponents couldn't take their eyes off the pinstripes in the Yankee uniforms -- like a magician keeping your eyes busy with one hand, while palming a card with the other. The newsletter then proposed that this was a metaphor for what government regulators do in collusion with the medical community and the pharmaceutical industry -- keeping the alternative health community busy fighting major legislative initiatives (looking at pinstripes), while relentlessly picking the community's pockets clean, ex parte -- under the radar, and with no legislative approval required.
You would think that this was an easy concept to understand. It isn't. So once again, the alternative health community has allowed itself to become preoccupied by grandiose initiatives such as Codex, and totally ignored one of the biggest thefts of the century going on right now -- a theft so profound, it could easily trump every other issue out there. And for the most part, only a handful of industry pundits and organizations such as the National Health Federation seem to have noticed. The implications of this petition are profound and far reaching and will be devastating to your ability to access nutraceuticals and herbal supplements -- if allowed to continue. Fortunately, you can help stop it.
GlaxoSmithKline Petitions the FDA
The FDA's longstanding position has been that weight loss claims are permissible structure/function claims because being overweight is not a medical condition. However, the petition seeks to reclassify weight loss health claims as disease claims and urges the FDA to change its position on the grounds that:
- Recent evidence establishes that being overweight is a risk factor for disease
- Consumers believe that there is a relationship between weight loss and a reduction of risk of disease
- Claims that a product will reduce a risk factor for disease are disease claims
- The use of ineffective therapies can divert consumers from safe and effective therapies such as GSK's weight loss drug alli ™.
- Manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market.
Before moving on, let's deal with these five points.
Yes, it is absolutely true that recent evidence establishes being overweight as a risk factor for disease. But I wonder why GSK didn't petition the FDA to regulate the fast food industry to directly impact the level of obesity in the world today. Oh, of course, I forgot for a moment. There's no money in it, whereas alli is the only weight loss product that is actually already "approved" by the FDA. - Yes, consumers believe there is a relationship between weight loss and a reduction in the risk of disease; but if we follow this logic to its illogical conclusion, then anything the public comes to believe (no matter how they came to believe it) would be reason for goverment regulators to intervene in the sale of that product. As an amusing side note, look who currently helps "educate" the public that there is a connection between losing weight and a reduction in the risk of disease. http://www.gsk.com/infocus/obesity.htm. Talk about having your cake and eating it too!
- Excuse me! GSK is trying to say that claims that a product will reduce a risk factor for disease are the same as disease claims? That's preposterous. New research, released as recently as just a couple of days ago found that eating a Mediterranean Diet, reduces the risk of Type I diabetes. According to GSK's logic, the Mediterranean diet would now fall under FDA guidelines and could no longer be promoted publicly as providing health benefits. Perhaps GSK is preparing to publish an "approved" diet book in the next few months. Well, if not a book, at least a diet plan. Oh my gosh! They are! http://www.myalli.com/whatstheplan.aspx.
- Absolutely, the use of ineffective therapies can "divert" consumers. And I'm sure, it was just an oversight that the petition didn't mention that recent research now shows that cholesterol lowering drugs such as GSK's Mevacor probably do more harm than good -- thereby distracting consumers from more beneficial (and safer) natural alternatives. (But that would take business away from GSK.)
- Hmm! I wonder what manufacturers have submitted such disease claim petitions for weight loss so they could take advantage of a favorable decision on the petition? Oh, silly me. At this point in time, GSK's alli™ is the only FDA approved, over-the-counter weight loss product. Thank goodness the FDA approved it, though. It works so well and has such "interesting" side-effects! How clever of GSK to get it approved.
The bottom line is that GSK says weight-loss dietary supplements don't work and that obesity and the secondary diseases like diabetes, cancer, and cardiovascular problems it is linked with are too serious a matter for dietary supplements to be making claims (not about the diseases, but about weight loss in general) without pre-market, pharma-style, disease claim approval.
All sarcasm aside, GSK's petition is well-written, even if based on faulty logic, and will find much support within the FDA's bureaucracy. In fact, it's in perfect alignment with the revised labeling guidelines the FDA introduced just last year. GSK's petition specifically address a number of weight loss alternatives currently available, from hoodia to bitter orange, and states, "There is no credible scientific evidence that would support any type of a claim accompanying a weight loss supplement." And then for added measure says that in those cases where there are indeed such studies, the studies are not rigorous enough or numerous enough, and therefore should be discounted. How convenient!
The FDA's decision making process on the petition will run to the end of October -- approximately. Right now, the odds are probably about 60:40 the FDA will deny the petition. Certainly every fiber of their being would love to grant it, but the fear that they might be overstepping their bounds, that a public suddenly denied access to their favorite weight loss products might scream in rage and cause their legislators to publically reverse an FDA decision is probably enough to hold them in check -- this time.
GlaxoSmithKline
But enough of the petition for a moment. Since GSK has decided to open a can of whoop-ass on the alternative health industry, I believe it is only fair to take a look at this company and get a sense of what might be motivating their petition -- other than concern for the public's health, that is.
Does GSK sell potentially risky products?
According to a major study conducted in the United States, Europe and Australia, patients who take the widely prescribed AIDS drug abacavir, manufactured by GSK, run nearly double the risk of heart attack compared with those who take other antiviral medications. The study, led by researchers at the University of Copenhagen, sifted through data from more than 33,000 patients starting in 1999. It found that the risk of heart attack rose nearly 90 percent for those prescribed abacavir. John Pottage, a vice president for GlaxoSmithKline, called the results "provocative." (At the very least, I would say.) The FDA made clear that although they are reviewing the data, they are not advising doctors to stop prescribing abacavir at this time.
A 2007 study found that GSK's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%. By coincidence, the study's author was then savagely assaulted. As reported in Counterpunch, a coordinated attack on the study's author, Dr. Steven Nissen, began appearing simultaneously in media all around the world. According to CounterPunch, "More than one story from ostensibly different sources derisively referred to Dr. Nissen as 'St Steven, the Patron Saint of Drug Safety', and 'Saint Steven the Pure'."
Among Dr. Nissen's attackers was FDA spokesman Douglas Arbesfeld. Coincidentally, Mr. Arbesfeld previously worked at the PR firm MS&L, where one of his clients was -- you guessed it -- GlaxoSmithKline. Former FDA Deputy Commissioner Dr. Scott Gottlieb, also connected with MS&L and GSK, ridiculed Nissen in a Wall Street Journal editorial. "Two more members of FDA's alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as an anonymous blogger, likewise referring to Dr. Nissen as a 'self-appointed and media-anointed Patron Saint of Drug Safety' and 'Saint Steven the Pure'." Makes you wonder who coordinated all of these talking points, doesn't it?
And then there's Paxil, GSK's antidepressant. The FDA reviewed two studies which found that women who took Paxil in the first three months of pregnancy were 1-1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. In addition, GlaxoSmithKline has now lost several lawsuits because it knowingly concealed years of negative information about the serious adverse reactions to Paxil. Not to mention the fact that as a result of GSK's fraudulent marketing of Paxil as non-addictive, they lost a major settlement in a class action suit filed on behalf of patients who got hooked on the drug, and then found they were unable to stop taking it.
Even now, GlaxoSmithKline faces a number of ongoing lawsuits regarding Paxil. For more information, or to participate in one of those lawsuits, check out: http://www.lawyersandsettlements.com/case/paxil-heart-defects-newborn.html.
But enough about GSK's commitment to your health. We could go on and on here. Suffice it to say: GSK's claim to be concerned for the reliability of studies concerning weight loss appears, at the very least, to be disingenuous.
The danger in the GSK petition
So why am I so concerned about the GSK petition?
First of all, it's an astounding expansion of the scope of the FDA labeling guidelines I mentioned earlier. As I mentioned in my blog on that issue, the key point in the guidelines is that "any herb or supplement that actually has any beneficial effect should be regulated by the FDA as if it were a drug if it actually helps with any medical condition" unless it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." At the time I wrote the blog, I expressed concern that based on the guidelines as written, if you were to claim on a label that drinking bottled water helped relieve a medical condition such as severe dehydration ( not just a medical condition, but a medical emergency), the new guidelines would mandate that water now be regulated as a drug. At the time, many in the alternative health community snickered at these concerns. Some people even left comments on the blog to that effect. But let me ask you now: What is GSK's petition to the FDA but an absolute expansion into the exact absurdity that I warned about? If you can claim that being overweight (an almost entirely self-inflicted state) is a medical condition for which all claims must be regulated because being overweight can "lead" to medical conditions, then there is no health related issue that cannot likewise be claimed to be a medical condition? What health issue is exempt?
What about vitamin C? A shortage of vitamin C in the diet leads to scurvy, a medical condition. By the applied logic, vitamin C should then be regulated as dealing with a medical condition and subject to the same rules. And what about dehydration? If no one can tell you that vitamin C provides health benefits, why would you buy it? Dehydration leads to medical conditions too, so water should also be regulated, yes? If no one can tell you that drinking water is healthier than drinking soda, why would you drink it?
You get the idea!
And if you think no one would ever bend and distort the FDA guidelines to do something that silly, think again. GSK just did! And the FDA is seriously considering their petition.
By the way, for those of you living outside the US, don't be smug. As I mentioned in the last issue of the newsletter, regulator's in the US and the rest of the world (particularly Europe) are moving ever closer in their regulatory zeal. And considering that the US is already more liberal than virtually all of the EU and Canada, you can be sure that any tightening in the US will be more than mirrored in your neck of the woods.
And so for the second time in less than two months, I find myself inspired to finish a newsletter with a quote from the movie, The Lord of the Rings. For all those of you who think that GSK's petition does not affect you, I once again give you Aragorn.
Aragorn (to Frodo): Are you frightened?
Frodo: Yes.
Aragorn: Not nearly frightened enough. I know what hunts you.
And in conclusion, I encourage you to check out the National Health Federation's call to action: http://www.thenhf.com/press_releases/pr_27_may_2008.html.
Fwd: Re: [Abes_Kids] New Book by a Kid
aaron smith <ayn_seeker@yahoo.com>