Pharmaceutical industry rips off government more than the military

The drug industry has surpassed the defense industry to become the biggest defrauder of the federal government, as determined by payments it has made for violations of the False Claims Act (FCA), according to a new Public Citizen study released in mid-December.

The Pentagon used to be the leading recipient of private-sector fraudulent deals, but the mantle has been passed now to the Department of Health and Human Services. GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough were the largest offenders.

According to the study, the practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments.

“Desperate to maintain their high margin of profit in the face of a dwindling number of important new drugs, these figures show that the industry has engaged in such activities as dangerous, illegal promotion for unapproved uses of drugs and deliberately overcharging vital government health programs, such as Medicare and Medicaid,” said Dr. Sidney Wolfe. He compiled and analyzed the data with physicians from the Johns Hopkins General Preventive Medicine program, Drs. Sammy Almashat and Charles Preston, as well as Columbia University public health student Timothy Waterman, all of whom worked at Public Citizen.

In some of cases, companies denied illegal activity such as fraud and kickbacks while making major payments to settle investigations, and the government agreed to settlements rather than pursue the cases further.

“The danger to public safety and loss of state and federal dollars that comes with these violations require a more robust response,” Wolfe said.

Dr. Grout’s comment:

Dr. Wolfe hit the nail on the head. Expect to see more fraud, since nobody is going to prison and the companies settle without any admittance of guilt. Furthermore, the companies have deep pockets and they fund an army of Washington DC lobbyists who write large campaign checks. The couple hundred dollars that you and I might give to a candidate barely registers. Add to that, ubiquitous TV advertising that makes people think it is normal to take a daily array of drugs.

There is so much prescription drug use now that excreted dosages show up in our drinking water – people who have never taken a hypertensive drug, for example, can test positive for it.

And there is related news – the December 28^th Wall Street Journal ran an article, “So Young and So Many Pills.” It says more than 25% of kids and teens in the U.S. take prescription drugs on a regular basis. The biggest sellers: asthma meds, ADHD meds, antidepressants, antipsychotics, antihypertensives, sleep aids, non-insulin diabetes, and statins.

The FDA rewards drug companies for testing medications in children. “In more than a third of these studies,” the WSJ reporter tells us, “there have been surprising side effects … Long-term effects of drugs in kids are almost never known since pediatric studies, like those in adults, tend to be relatively short.”

The article quotes a doctor in Arkansas who says obesity is the number one problem he sees in kids, yet only about 10 percent of the parents follow his recommendations for exercise and a change in diet. The addictive nature of today’s processed food makes it almost as hard to change our eating habits as it is to quit smoking.

For kids on the brain altering drugs and statins, there are safer answers that also give better results long-term. We’ve seen kids with ADHD and brain disorders make incredible strides with the drug-free BrainAdvantage program.

For the first time in two centuries, the current generation of children in America may have shorter life expectancies than their parents. Making kids pop handfuls of pills each week and suffer their side effects will not change this picture for the better. What can you do? Learn. Look behind the marketing messages and the effects of industry’s heavy-handed lobbying and understand how to protect yourself. For starters, read the book, An Alphabet of Good Health. Engage in the blog conversation.

Monsanto exerts influence on European GMO policies

The latest batch of diplomatic cables released by Wikileaks reveals how the Unites States exerts pressure on European countries to further the commercial interests of the biotech industry by promoting genetically modified foods. 

A cable from Craig Stapleton, the US ambassador to France, expressed his frustration with the idea that France might pass environmental laws that would hamper the expansion of GMOs:

"Europe is moving backwards not forwards on this issue with France playing a leading role, along with Austria, Italy and even the [European] Commission... Moving to retaliation will make clear that the current path has real costs to EU interests and could help strengthen European pro-biotech voices. In fact, the pro-biotech side in France -- including within the farm union -- have told us retaliation is the only way to begin to begin to turn this issue in France."

Jeffrey Smith, author of Seeds of Deception, said this in a “Democracy Now” interview:

"We’ve been saying for years that the United States government is joined at the hip with Monsanto and pushing GMOs as part of Monsanto’s agenda on the rest of the world. This lays bare the mechanics of that effort. We have Craig Stapleton, the former ambassador to France, specifically asking the U.S. government to retaliate and cause some harm throughout the European Union.”

A story broke in EL Pais on December 19th, revealing that the Spain has been working hand in hand with the U.S. to protect the interests of the biotech industry against those EU countries that hold national bans on GE crops. Spain, cultivates the most GE maize (Monsanto MON810) in Europe and is very worried by the rise of the anti-GE movement in Spanish society. The French are also mostly against GE crops and Germany has been introducing GE crop bans - allying with countries such as Austria, Luxembourg and Italy. Spain doesn't want to be outnumbered in Europe on this issue and has been looking for support elsewhere.

Dr. Grout’s comment:

This is pretty ugly. And there is more.

Last September, Jeremy Scahill’s article in The Nation exposed that in 2008-2009 Monsanto hired the controversial military contractor known as Blackwater. Scahill wrote that “Blackwater, through [its sister company] Total Intelligence, sought to become the ‘intel arm’ of Monsanto, offering to provide operatives to infiltrate activist groups organizing against the multinational biotech firm.” This is clear evidence of what animal activists and health advocates who oppose GMOs are up against.

Animal studies have indicated serious health risks associated with GM food consumption including infertility, immune dysregulation, accelerated aging, dysregulation of genes associated with cholesterol synthesis, insulin regulation, cell signaling, and protein formation, and changes in the liver, kidney, spleen and gastrointestinal system. The only human feeding study ever published on GMOs, the 2004 Netherwood study, revealed that transgenes from soy transfer into the DNA of bacteria inside our intestines and continue to function. So eat a handful of chips made from GMO corn and you have a pesticide replicating in your gut.

The American Academy of Environmental Medicine has called for a moratorium on genetically modified foods saying, “There is more than a casual association between GM foods and adverse health effects.” But the U.S. government has not agreed to examine the health effects of GMOs. It should.

In the U.S., we have not won the battle to have GMOs labeled. We can avoid most of the GMOs by not eating processed foods because 80 percent or more of all processed food has GMOs in it. Soda, for example, is often made with high fructose corn syrup that is made from genetically modified corn. Unless the label specifies “pure cane sugar,” you are probably eating something made from genetically modified sugar beets. And almost all the soy found in food products is GM.

The Hershey Company plans to reformulate its European products to be free of GMOs in order to meet consumer demand and to comply with the non-GMO requirements of Asda, the U.K. subsidiary of Wal-Mart that will be Hershey's exclusive retailer in the U.K. However, Hershey's has no intentions of changing any of its U.S. formulas, all of which are tainted with GMOs.

What can we, as individuals, do about GM food products? We can refuse to buy them. We can call or send letters to the consumer products divisions of the companies whose foods we are concerned about, asking them if there are any GM elements in their products. The companies will begin to realize that we are concerned and that we care. The power of the pocketbook is enormous – look at what happened with BPA in our water bottles and baby bottles – it is no longer present because of the outcry of the Mommy Blogosphere. We can do the same for any other GM foods – we just have to care enough to write, and to find a substitute.

Oregano protects grilled meats from bacteria and cancer-causing compounds

Adding oil of oregano to meat before grilling could reduce the formation of potentially cancer-causing compounds by up to 78 percent, University of Arizona researchers have found. It also helps inactivate harmful E. coli O157:H7 in the meat.

Research conducted by U.A. microbiologist Sadhana Ravishankar has shown that a compound in oregano reduces the formation of heterocyclic amines, the potentially cancer-causing culprits that can form in grilled meat.

"We are preventing the formation of potentially carcinogenic compounds in the grilled meat itself, so people can eat safer grilled meat," said Ravishankar, an assistant professor in the U.A.'s department of veterinary science and microbiology in the College of Agriculture and Life Sciences.

Heterocyclic amines form in grilled, charbroiled or fried meat in two essential steps. First, a raw juicy hamburger is slapped on the grill. As the meat heats up, amino acids and glucose in the meat react with each other to create molecules known as intermediates. Next, these intermediates react with creatinine, a molecule that is present in muscle. The result is heterocyclic amines.

Once the nice and crispy hamburger is eaten, the heterocyclic amines potentially could lead to cell malfunction. Several epidemiological studies have shown a possible correlation between the consumption of well-done meats and different types of cancers in humans.

So maybe people can live without that extra crispy texture on their meat. Unfortunately that strategy has a pitfall too: There are established standards for cooking ground beef in order to eliminate harmful E. coli bacteria in the vast majority of commercial meat. Restaurants often recommend well-done meat to minimize the potential for foodborne illness.

"We added the active ingredient of oregano oil, called carvacrol, to the meat. Then we grilled the meat, and we were able to reduce the formation of these compounds," said Ravishankar. "Carvacrol has anti-oxidative properties, so we are thinking that it binds to or reacts with some of the intermediates and prevents them from forming the heterocyclic amines. The mechanism is not clear yet."

Carvacrol also has antimicrobial properties that inactivate E. coli: a membrane-active compound, it breaks the chain of fatty acids that makes up the outer membrane of an E. coli cell, causing the cell to leak its contents.

Her study was published in the Journal of Agricultural and Food Chemistry.

Dr. Grout’s comment:

Ravishankar's research has shown for the first time a way to simultaneously inactivate harmful E. coli and reduce the formation of potentially carcinogenic compounds in grilled meat.

It is important not to confuse oil of oregano with the oregano that is used as a spice for cooking. The common oregano spice is typically Origanum Marjoram, while oregano oil is derived from Origanum Vulgare. Oil of oregano is a natural substance extracted from wild oregano plants, and two key compounds found in it are carvacrol and thymol. Quality oregano oil should sell for between $10 to $16 per 15 ml at health food stores.

The ancient Greeks were one of the first people to recognize oregano oil for its health benefits and medicinal qualities. It is known to be a potent antiviral, antibacterial, antifungal, and antiparasitic oil that can reduce pain and inflammation and effectively fight off infections.

IOM report on vitamin D is wrong, wrong, wrong

New vitamin D recommendations, released by the health arm of the National Academy of Sciences, the says that persons between the ages of 1 and 70 do not need more than 600 IU of vitamin D daily. The Institute of Medicine (IOM) report also makes what many feel is an outrageous claim that few people are actually vitamin D deficient.

This is the government’s first official vitamin D recommendation since 1997. The IOM’s committee set a new “dietary reference intake” for vitamin D. Assuming that a person gets virtually no vitamin D from sunshine, and that this person gets adequate amounts of calcium, the committee recommends the following:

·         Infants age 6 to 12 months: adequate intake, 400 IU/day; maximum safe upper level of intake, 1,500 IU/day

·         Age 1-3 years: adequate intake, 600 IU/day; maximum safe upper level of intake, 2,500 IU/day

·         Age 4-8 years: adequate intake, 600 IU/day; maximum safe upper level of intake, 3,000 IU/day

·         Age 9-70 years: adequate intake, 400 IU/day; maximum safe upper level of intake, 4,000 IU/day

·         Age 71+ years: adequate intake, 800 IU/day; maximum safe upper level of intake, 4,000 IU/day

This raises the recommended vitamin levels from 200 to 600 IU/day for most Americans. However, that is far lower than many doctors and major medical groups have been advocating. The Alliance for Natural Health said the IOM guidelines defy overwhelming scientific evidence that confirms the significant medical benefits of higher vitamin D levels, and that one-third of Americans are vitamin D deficient.

The IOM committee dismissed concerns that many Americans and Canadians are vitamin D deficient, noting that there is no scientifically validated level that's considered optimum. Even so, the panel concluded that for 97% of the population, a blood level of 20 nanograms of vitamin D per milliliter is sufficient.

Several major medical groups, including the Endocrine Society and the International Osteoporsis Foundation, have concluded that a level of 30 ng/ml is necessary for optimal bone health. Studies have also shown that at levels below 30 ng/ml, the body seeks calcium for everyday needs by leaching it from bones.

Dr. Michael Holick, a professor of medicine at Boston University School of Medicine who testified before the IOM committee, recommends that adults take 2,000 to 3,000 IUs per day and notes that he had done studies giving subjects 50,000 IUs twice a month for six years and seen no harmful effects.

Dr. Grout’s comment:

We know that vitamin D in all forms (sunlight, sun lamps, or supplements) reduces the incidence of respiratory infections. It boosts immune function and suppresses inflammation. Flu viruses (including swine flu) induce a massive inflammatory response that can kill the victim. In other words, it is not the virus that often kills, but the body’s hyper-reaction to the virus in the form of uncontrolled over-production of pro-inflammatory cytokines. Vitamin D down-regulates the expression of pro-inflammatory cytokines such as tumor necrosis factor-alpha. As people age, they often over-express these same destructive pro-inflammatory cytokines. The result is chronic low-level inflammation that damages aging arteries, joints, and neurons. By down-regulating excess pro-inflammatory cytokine production, vitamin D can save the lives of those stricken with acute influenza, or the dozens of inflammatory diseases that afflict millions of aging Americans each year.

This is why it is said that vitamin D is more effective than the flu vaccine, which almost everyone except the CDC says is not very effective. This from the British Medical Journal: "The optimistic and confident tone of some predictions of viral circulation and of the impact of inactivated vaccines, which are at odds with the evidence, is striking. The reasons are probably complex and may involve a messy blend of truth conflicts and conflicts of interest…"

Many feel conflicts of interest explain why the IOM made this very conservative recommendation. The Alliance for Natural Health reports:

There is, unfortunately, a hidden agenda afoot. A pharmaceutical company is developing a patentable man-made vitamin D analog – yes, a synthetic drug version of vitamin D. And Glenville Jones, PhD, one of the committee members who determined the new vitamin D guidelines and who is quoted as saying that under these guidelines, most people ‘probably don’t have vitamin D deficiency’ and ‘We think there has been an exaggeration of the public’s interest in vitamin D deficiency,’ is an advisor for that same pharmaceutical company.

During the Industrial Revolution, rickets were epidemic in temperate zones where the pollution from factories blocked the sun’s ultraviolet rays. Today, rickets are making a comeback. Headlines tell us the growth of the computer generation and our sedentary lifestyle have led to a vitamin D deficiency and a rise in cases of rickets. The doses recommended by the IOM may be enough to prevent rickets, but are not sufficient to fulfill other important functions.

Studies have linked low vitamin D levels to a higher risk of a slew of chronic health problems including heart disease, diabetes, cancers, auto-immune diseases, infections, osteoporosis, depression and cognitive decline.

Consider this: Humans evolved near the equator and spent days outdoors, allowing the skin to generate ample amounts of this vitamin. About 50,000 years ago, some of our ancestors migrated toward the poles, where winter sunlight isn’t intense enough for vitamin D production. However, their diet of vitamin D-rich fish compensated for the deficit. The new recommended daily dose of 600 IU is equal to just four minutes of mid-day full-body summer sun exposure. About thirty minutes of sunshine would produce approximately 4,000 to 5,000 IU of natural vitamin D in many American latitudes, which the new guidelines indicate may be an overdose. Nature knows best.

Today, we don’t get outside much and when we do, we tend to slather on sunscreen which blocks our ability to make D. Cod liver oil is a time-honored source of vitamins D and A; in the first half of the 20^th century, school children had to take one spoonful each day.

Airport scanners emit cancer-causing radiation

Dr. Russell Blaylock, neurosurgeon, author, lecturer, is advising travelers to opt out of X-ray scans at the airport. He says:

“Radiation increases cancer risk by damaging the DNA and various components within the cells. Most scientists think that the most damaging radiation types are those that have high penetration, such as gamma-rays, but in fact, some of the most damaging radiation barely penetrates the skin.

“One of the main concerns is that most of the energy from the airport scanners is concentrated on the surface of the skin and a few millimeters into the skin. Some very radiation-sensitive tissues are close to the skin - such as the testes, eyes, and circulating blood cells in the skin.

“This is why defenders using such analogies as the dose being 1,000-times less than a chest X-ray and far less than what passengers are exposed to in-flight are deceptive. Radiation damage depends on the volume of tissue exposed. Chest X-rays and gamma-radiation from outer space is diffused over the entire body so that the dose to the skin is extremely small. Of note, outer space radiation does increase cancer rates in passengers, pilots, and flight attendants.

“As we grow older, our DNA accumulates a considerable amount of unrepaired damage, and under such circumstances even low doses of radiation can trigger the development of skin cancers, including the deadly melanoma.

“About 5 percent of the population have undiagnosed abnormal DNA repair mechanism. When exposed to radiation, this can put them at a cancer risk hundreds of times greater than normal people.

“It also has been determined that when skin is next to certain metals, such as gold, the radiation dose is magnified 100-fold higher. What if you have a mole next to your gold jewelry? Will the radiation convert it to a melanoma? Deficiencies in certain vitamins can dramatically increase your sensitivity to radiation carcinogenesis, as can certain prescription medications.

As for the assurances we have been given by such organization as the American College of Radiology, we must keep in mind that they assured us that the CT scans were safe and that the radiation was equal to one chest X-ray. Forty years later we learn that the dose is extremely high, it is thought to have caused cancer in a significant number of people, and the dose is actually equal to 1,000 chest X-rays.” 

“When the real effects of these scanners on health become known, Secretary of Homeland Security Janet Napolitano and the rest of the gang who insist the scanners are safe will be long gone.”

Dr. Grout’s comment:

I agree. Thank you Dr. Blaylock for a clear description of the issue.

Earlier this year, the President’s Cancer Panel issued a surprisingly candid report about how to reduce the environmental factors we know contribute to the high rate of cancer. One of the report’s recommendations was to avoid unnecessary medical screening because X-rays cause cancer.

For this same reason, many of us applauded the revised guidelines released a year ago by the U.S. Preventive Services Task Force that called for less mammography screening – a mammogram is an X-ray of the breast.

It is projected today that 1 in 3 women, and 1 in 2 men will get cancer in their lifetime. The TSA needs to find a better way to provide security than putting Americans at risk for cancer.

San Francisco bans toys in McDonald’s “happy meals”

It is official: a ban in California’s Santa Clara County and effective December 2011 in the city of San Francisco, will prohibit restaurants from offering a free toy or prize with meals that exceed 600 calories, 650 mgs of sodium, and fat levels exceeding 35% of total calories. All meals (except breakfast) must also contain a half-cup of vegetables and fruit.

“It’s only going to pick up steam,” said Ken Yeager, the Santa Clara County supervisor who introduced the ban. “The fast-food chains must realize that the tide has turned.” Yeager says that officials in New York, Chicago, and Orange County have contacted him about possible measures of their own.

The Center for Science in the Public Interest (CSPI) is preparing a case against McDonald’s that would further ban the use of toys to market Happy Meals. As CSPI litigation director Stephen Gardner said, the suit claims such marketing is illegal under various state consumer protection laws irrespective of the alleged health risks.

Dr. Grout’s comment:

Interesting move. McDonalds has been very cautious in responding to this. A company spokeswoman said, “Parents tell us it’s their right and responsibility – not the government’s – to make their own decisions and to choose what’s right for their children.” Certainly many people feel that this is an over-reach by the “nanny state.” And it may be.

But it begs the question: How do we intervene in the CDC projection that 1 in 3 people will have diabetes by the year 2050 unless something is done to curb unhealthy lifestyle trends in the United States? Nearly 1 in 5 youngsters is now obese. More than 50% of children will suffer from chronic health diseases in their childhood ranging from ADHD and asthma to obesity and diabetes, according to a JAMA February 17, 2010 article. Children can't change their exercise and eating habits by themselves. They need their families to set the example. Chef Jamie Oliver applauded the ban. He told CNN the job of the nanny is to take care of the child. The government already makes tobacco and alcohol off limits from kids because those products are not healthy. The FDA is gearing up to ban the addition of caffeine in alcoholic beverages like Four Loko because “the combinations of caffeine and alcohol in these products pose a public health concern.” So too does a lot of the food sold today.

What concerns me is how we decide what good food is. The subject is fraught with politics – everything from special interests designing the USDA food pyramid and farming laws that favor large corporate agriculture, to soda manufacturers “partnering” with dietary associations to develop nutrition guidelines and industry-sponsored studies that amazingly find no fault with chemical additives like synthetic sugars and high fructose corn syrup.

This new ban says suggests fat levels should not exceed 35% of total calories. Where is that written? Remember in the 1980s how pasta and starchy crabs were heavily promoted? All that did was sell a lot of pasta makers and spike everyone’s insulin levels. Now the mainstream news delivers much better information about carbs, that those kinds of carbs are the bad carbs and veggies are the good carbs. But we are still being fed bad information about fats. The old dogma is that eating fat makes you fat. Wrong. There are bad fats including soy and corn and most other cheap vegetable oils, and any fat that has been re-heated and used over and over to fry foods in a fast-food joint. There are good fats including butter, grass fed meats, fish oil, nuts, lard, and unrefined coconut and olive oil. Pervasive lobbying from special interest groups still clouds that picture for many.

Good fats are the prescription for providing energy, making strong cell membranes, making hormones, and eating in moderation. Without fat at the table, your body has trouble absorbing the vitamins and minerals from the veggies on your plate. Without fat, you don't feel full and stop eating. Eating hamburger from cows or buffaloes raised organically on grass is a good quality fat; a fast food hamburger from a cow fed hormones, steroids, genetically modified corn and then positioned between two refined pieces of bread, slathered in hydrogenated vegetable oils masquerading as mayonnaise and high fructose corn syrup masquerading as a catsup, is not. Eating truly unprocessed coconut oil may even help you lose weight. Eating a salad with the typical manufactured salad dressing made of vegetable oils will likely pack on the pounds. Many native people ate a diet that was considerably more than 35 percent fat – but it was good fat.

Let’s start improving the discussion about fat.

Drinking soda increases risk of diabetes, metabolic syndrome

A large study published in Diabetes Care found that people who had a soda or two a day, compared to people who one sugary drink a month, had a 26 percent increased risk of diabetes, and a 20 percent increased risk of metabolic syndrome.

When researchers adjusted for body mass, those numbers fell – but only by about half, which means even slim people can get diabetes if they regularly consume sugary drinks: soda, sweetened tea, sports drinks, “juice” drinks, vitamin waters, and “energy” drinks.

In fact, drinking just one 12-ounce serving of soda per day increased a person's risk for type 2 diabetes by about 15%.

The meta-analysis pooled data from 11 studies that involved more than 300,000 participants with 15,043 cases of type 2 diabetes and 19,431 participants with 5,803 cases of metabolic syndrome. Participants were followed from four to 20 years.

“What’s really important is a very clear, significant positive association with the risk of type 2 diabetes,” said researcher Vasanti Malik, ScD, a fellow in the nutrition department at the Harvard School of Public Health. “There are a lot of factors that contribute to type 2 diabetes, but this is one modifiable factor that would be very easy for people to change.”

The kinds of drinks or the kinds of sugar - sucrose, high-fructose corn syrup, or fruit juice concentrates – were not studied separately, but the authors say their metabolic effects are essentially the same. A 100 percent juice drink is not considered sugar-sweetened.

The American Beverage Association disputed the study’s results. “It is overly simplistic, and simply misleading, to suggest that reducing or eliminating sugar-sweetened beverages from the diet will uniquely lower incidence of serious health conditions such as diabetes or metabolic syndrome,” Dr. Maureen Storey, senior vice president for science policy for the American Beverage Association, said. “There is a critical flaw in the design of this meta-analysis in that the authors focus solely on the impact of one calorie source – sugar-sweetened beverages – on weight, rather than looking at all sources of calories.”

Malik said the individual studies accounted for known differences between the two groups of people that might explain the different rates of type 2 diabetes and metabolic syndrome.

“Sure, people who drink soda tend to be less physically active, they might eat more saturated fat,” she said. But even after the researchers accounted for weight differences, the association between sweetened drinks and diabetes persisted, she said.

Dr. Grout’s comment:

Liquid sugar, as these beverages are often called, causes blood sugar levels to rollercoaster with quick spikes and rapid falls. If for years you eat more sugar than is needed by the muscles for exercise, you strain the pancreas, asking it to make excess insulin constantly to lower your blood sugar level. When the pancreas starts to lose control – you have a fasting blood sugar levels of 110 mg/dL or greater – you have metabolic syndrome. Eventually, the pancreas cannot make enough insulin, and the blood sugar level remains chronically high – a fasting blood glucose level of 126 mg/dl or higher. At this point, the patient is diagnosed with diabetes.

The researchers are not saying sugary drinks are the only factor associated with diabetes, but it’s one that can really make an impact if it’s reduced.

Christiane Northrup blasted for speaking up about thermography

Writing in the Huffington Post, Dr. Christiane Northrup said she is disappointed that every October – breast cancer awareness month – that mammography is heavily promoted and nothing is said about the benefits of thermography: “I understand that mammography has been the gold standard for years. Doctors are the most familiar with this test, and many believe that a mammogram is the best test for detecting breast cancer early. But it's not. Studies show that a thermogram identifies precancerous or cancerous cells earlier, and produces unambiguous results, which cuts down on additional testing--and it doesn't hurt the body. Isn't this what women really want?”

However, reporter Nara Schoenberg of the Chicago Tribune, scolded Northrup: “If the Internet buzz about a pain-free, radiation-free alternative to mammography sounds too good to be true, there's a reason for that. Breast thermography… has never been proven effective for routine breast cancer screening in a large-scale, randomized study… the FDA has never approved it for that purpose and in 2009 issued a warning letter accusing an Idaho healthcare provider of marketing thermography as a mammogram replacement."

Dr. Grout’s comment:

Ms. Schoenberg seems quick to defend the mammography business status quo when so many others are starting to change their tune. She appears to be unaware of the Norwegian breast-cancer screening program which analyzed years of data from 40,075 women with breast cancer. Researchers found mammography had little benefit. Their results, published September, 2010 in the New England Journal of Medicine, found the relative reduction in mortality that can be attributed solely to screening mammograms is a surprisingly low 2%, indicating that the decline in mortality attributed to screening alone may be as few as 2 deaths prevented per 100,000 women screened. Dr. H. Gilbert Welch's accompanying editorial said this is so small it may as well be zero.

But there are randomized trials for mammography, and not for thermography as Schoenberg points out. Terrific. The more we study mammography, the more we prove it is woefully inadequate as a primary screening tool. Even the head of the American Cancer Society, Dr. Otis Brawley, told NPR in October: “You have to remember the limitations of mammography... It is not a very good test for younger women. It's very difficult for a mammographer to pick up a cancer in a breast in a woman in her 20s or 30s. It's difficult for mammographers to pick it up in their 40s, and it gets easier as a woman gets older. We need better tests is what I'm really saying, and we need to support research to develop those better tests. Thermography is something that some people have advocated, but it's not been tested in a prospective randomized trial… I think that we need to support some of the research in the many things like thermography…”

Schoenberg is inaccurate when she suggests that people like Northrup are saying we should do away with mammography in favor of thermography. Wrong. It is a matter of which technology is better at earlier detection. Thermography wins that debate hands down. Thermography can see the heat signature of a tumor's formation years earlier than mammography can see a lump. When you think you have something to investigate further, then the radiation and compression of mammography are well worth doing. If you need to do a biopsy, a mammogram can pinpoint the spot; a thermogram cannot.

It's time to drop the industry-sponsored dogma and look at what is best for women. Even JAMA in 2009 challenged the “still unquestioned value of mammography.” Deep pocketed companies like General Electric make mammography machines and can afford to conduct randomized trials. “Big business” doesn’t make thermography machines so no one has been able to afford randomized trials yet. However, there are 800 peer-reviewed studies on thermography, and the studies on mammography just continue to document its weakness as a screening tool. If we want to decrease the deaths from breast cancer, we must look at different technologies. Time for the ACS or the NIH to fund the randomized trials on thermography so the Schoenbergs of the world stop parroting that first line of defense in support of the old dogma. It’s women who suffer in the end.

ASU Scientist warns about overuse of germ killing products

Killing microorganisms has become a national obsession. A pair of antimicrobial compounds known as triclosan and triclocarban are the current weapons of choice in our war of attrition against the microbial world. Both chemicals are found in an array of personal care products like antimicrobial soaps, and triclosan also is formulated into everyday items ranging from plastics and toys to articles of clothing.

According to new research by associate professor Rolf Halden of the Biodesign Institute at Arizona State University, these chemicals are not safe for human health or the environment. And, they do not work.

“The culture of fear leads people to make impulsive decisions and buy a lot of antimicrobial products that are not really needed,” Halden says. “It's a profitable market to be in, but not one that is ultimately sustainable or a good idea.”

Levels of triclosan in humans have increased by an average of 50 percent since 2004, according to newly updated data from the CDC. Triclosan and triclocarban are present in 60 percent of all rivers and streams nationwide and analysis of lake sediments have shown a steady increase in triclosan since the 1960s. Antimicrobial chemicals appear in household dust where they may act as allergens. Also, 97 percent of all U.S. women show detectable levels of triclosan in their breast milk.

Halden and his team conducted a series of experiments aimed at tracking the environmental course of the active ingredients in personal care products. The disturbing results of their research indicate that triclosan and triclocarban first aggregate in wastewater sludge and are transferred to soils and natural water environments, where they were observed to persist for months or years.

 “We make 13 billion pounds of dry sludge per year,” Halden notes. “That is equal to a railroad train filled with sludge stretching 750 miles from Phoenix to San Francisco.” One half of this sludge winds up on agricultural fields. The potential for these chemicals to migrate into food or leach into groundwater, has not received adequate consideration. It is likely that antimicrobials are capable of moving up the food chain, through a process known as biomagnification.

Halden noted the thresholds for killing microbes are much higher than those for life forms like algae, crustaceans and fish. "This explains why residual concentrations of antimicrobials found in aquatic environments are still sufficiently harmful to wipe out the small and sensitive crustaceans, which are critical to the aquatic life cycle and food web," Halden stated.

Dr. Grout’s comment:

The antimicrobial triclosan began its use in the medical surgical arena in 1964. Since then, industry’s drive to convince consumers of the need for antimicrobials has been aggressive and highly effective. Triclosan was first added to commercial liquid hand soap in 1987. Four years later, 76 percent of liquid hand soaps contained the chemical. Triclosan is added to plastic containers, toys and even clothing, too.

In 2005, the FDA asked an expert panel, which included Halden, to review all the available information on these chemicals. The panel concluded that regular use of antimicrobial products by the general public was no more effective against disease causing germs than simply washing thoroughly with regular soap and water.

In 2003 and 2009, University of Minnesota civil engineering professor William Arnold and his colleague Kristopher McNeill published their discovery that triclosan, when exposed to sunlight, generates a specific group of four dioxins – highly toxic compounds that are persistent environmental pollutants. The researchers found that levels of dioxins derived from the antibacterial soap ingredient triclosan have risen by 200 to 300 percent.

Killing microorganisms has become a national obsession. We can stop it by choosing to buy products without “antibacterial” on the label. This is one chemical we can easily do away with by reading labels and just not buying it.

“Smart pills” have embedded microchip for compliance

Novartis AG, one of the largest drug companies in the world, has announced a plan to begin embedding microchips in pills.

"We hope within the next 18 months to have something that we will be able to submit to the regulators," global head of development Trevor Mundel told Reuters news service. "The regulators all like the concept and have been very encouraging."

The silicon and metal sensor is activated by stomach acid. It then sends data via a wireless radio signal to another chip worn as a skin patch or embedded just under the skin which transmits the information wirelessly to a designated smartphone, e-mail account, etc. The chip's power expires after a few hours. The first use being studied is for a drug for transplant patients that helps avoid organ rejection. Since the drug itself is already approved and established, Novartis might be able to forgo clinical trials and simply conduct bioequivalence tests to show the second-gen pills have the same effect as the originals.

Anticipating that once the sensor-based technology is regulatory approved, the ‘smart-pill’ platform will be transferrable to different drugs, Mundel said future ‘smart-pill’ variants will be able to collect more advanced data, such as a patient’s heart rate, temperature and body movement, to ensure a drug is working effectively.

Rival firm Philips is bringing forward its IntelliCap technology, which was first showcased in 2008. MicroCHIPS, an American start-up, is developing smart, implantable microchips which have reservoirs to hold drugs or tiny monitoring devices. Vitality, an American firm, has come up with a cap for pill bottles that telephones hapless patients if they fail to take their medicine on time.

Dr. Grout’s comment:
 

Is this promising or just creepy? With chip-in-a-pill, we have something you swallow that can both monitor your vital signs and track compliance with prescription drug regimens. They are calling this “personalized medicine.”
 

This new technology will first be used with people who have had organ transplants. They are in a very precarious position; a “smart pill” may seem to make sense for those patients. But what happens when the chip is applied to a wider range of prescription drugs and perhaps vaccines? In the marketing business, this kind of things is called a "continuity program" – a way to make sure repeat sales happen on a regular basis.

Various studies have estimated that a third to half of prescription drugs are not taken as prescribed – or at all – because patients are worried about side effects or just don’t want to take so many drugs. Pharmaceutical companies lose significant revenue from patients skipping out on their prescribed pills; one industry study estimates needless hospitalizations as a result of such failings cost $100 billion a year.

Will patients clamor for more data about their health, much as banks’ customers embraced the internet as a means of keeping better track of their accounts? Or will people come to see the ability for drugmakers to keep such intimate tabs on their customers as too Orwellian?  It represents a new level of intrusion into patients' lives. Will you be forced to take, say, a statin drug which you don’t want to take in order to have the blood pressure medicine you really do want to take?

The microchip itself is said to be about the size of a grain of sand. Although much has been said about the chemical toxicity of discarded computer parts, there is no mention in any of the news reports about the safety of ingesting a circuit board, or the safety of this new form of EMF transmissions within the body.

BPA found in many grocery store foods

A research team from the University of Texas School of Public Health measured 105 human, cat, and dog foods from grocery stores in Dallas in March. They looked at fresh and canned food as well as food wrapped in plastic packaging. In 63 samples, they detected "quantifiable levels" of bisphenol A, often used to line food cans and to harden plastics.

Canned Del Monte Fresh Cut Green Beans was the worst offender of all products tested. Three cans contained between 26.60 and 65.00 ng of BPA per gram of food, which is equivalent to 26.60 to 65.00 ppb. Quantifiable levels of bisphenol A were found in cans of Chicken of the Sea Chunk Light Tuna in Water and in cans of Kroger Sweet Peas Garden Variety. Foods with plastic packaging, such as Chef Boyardee Spaghetti and Meatballs, had higher BPA levels than cans of the same food. BPA was detected in plastic-wrapped fresh sliced turkey. Canned Enfamil baby formula had more BPA than canned V8 juice.

Linda Birnbaum, a coauthor of the report, told Chemical & Engineering News that the low parts per billion levels detected are in line with previous reports on food from other countries and by U.S. environmental groups.

The levels found in the U.S. are nearly 1,000 times lower than the “tolerable daily intake” levels set by the by the Environmental Protection Agency (EPA) and the European Food Safety Authority (EFSA).

Whether the levels represent a concern, particularly for infants and small children, is under debate. Experts including Laura Vandenberg, a BPA researcher at Tufts University, and Fred vom Saal of the University of Missouri, Columbia, contend that EPA's BPA limit is too high.

Chemists have been formulating BPA-free can linings. The cans of tomato paste analyzed in the new study had non-detectable levels of BPA. Because acidic foods like tomatoes are known to enhance BPA leaching, the findings suggest that effective new linings exist and that companies are using them, says Ruthann Rudel of the Silent Spring Institute, a nonprofit research group.

Dr. Grout’s comment:

The take away message here is that consumer resistance causes the marketplace to change for the better. In March 2009, the six largest makers of baby bottles announced they would stop manufacturing baby bottles in the United States made with BPA. Last month, Canada added BPA to its official list of toxic substances, opening the possibility of regulating it. The FDA has not taken such action.

Epidemiological studies have linked human exposure to BPA with heart disease and diabetes in adults and abnormal behaviors in toddlers. Dozens of toxicology studies also connect BPA concentrations equivalent to the levels found in the U.S. population with a range of health problems. BPA is an endocrine disrupter - it acts like a hormone. It was discovered to be an estrogen in the 1930s.

Health standards established in the U.S. for exposure to toxic chemicals rest upon a core assumption: high-dose testing procedures adequately predict potential low-dose effects. A growing body of research now confirms that endocrine disruptors, like hormones, can also contradict the expectations of traditional regulatory testing.

Endocrinology is replete with cases in which hormone action at low levels differs dramatically from hormone action at high levels. For example, administering newborn mice a high dose (1000 μg/kg/day) of the estrogenic drug diethylstilbestrol (DES) causes weight loss in adult mice. In contrast, a dose of 1 μg/kg/day causes grotesque obesity in adulthood.

Radiation screening promoted to detect lung cancer

Annual CT scans of current and former heavy smokers reduced their risk of death from lung cancer by 20 percent, according to the largest study ever done of lung cancer screening.

The effectiveness of CT scanning for lung cancer has been debated for years because the test can pick up lung abnormalities like scars from past infections that are not cancer. Such irregularities "are common in heavy smokers and can result in costly anxiety-producing tests. CT scans use coordinated X-rays and a dye to provide three-dimensional views.

Chest X-rays have never been shown to save lives, according to Ned Patz, a professor of radiology at Duke University Medical Center who helped design the National Lung Screening Trial, a $250 million government-funded study conducted by the American College of Radiology Imaging Network and the cancer institute.

The trial involved more than 53,000 people ages 55 to 74 who had smoked at least 30 pack-years — one pack a day for 30 years or two packs a day for 15 years. Ex-smokers who had quit within the previous 15 years were included in the group. Each was given either a standard chest X-ray or a low-dose CT scan at the start of the trial and then twice more over the next two years. Participants were followed for up to five years. There were 354 lung cancer deaths among those who received CT scans and 442 among those who got X-rays.

The study found that for every 300 people who were screened, one person lived who would otherwise have died during the study. But one-quarter of those given CT scans were found to have anomalies, nearly all of which were benign. These false signals generally led to more worry, more CT scans and sometimes to lung biopsies and thoracic surgery.

Oncologists predict the study’s results would soon lead to widespread use of CT scans, in particular for older smokers, who have a one in 10 chance of contracting lung cancer.

But health officials involved in the study refused to endorse widespread screening of current or former smokers, saying more analysis of the study’s results is needed to further identify who benefited most.

Deaths due to all causes declined by 7 percent among study participants who received CT scans, suggesting the tests helped to detect other life-threatening diseases besides lung cancer.

 

“What we have found is that low-dose CT scan also gives information on cardiovascular disease, emphysema” and other pulmonary diseases, said Dr. Claudia Henschke, a clinical professor of radiology at Mount Sinai Medical Center and a longtime advocate for use of CT to screen for lung cancer. “Those are the three big killers of older people. There is just tremendous potential.”

Lung cancer will claim about 157,000 lives this year, more than the deaths from colorectal, breast, pancreatic and prostate cancers combined. Most patients discover their disease too late for treatment, and 85 percent die from it.

Dr. Grout’s comment:

Some might ask if this is a case of vested interests looking to maintain their market share – mammograms are ineffective and deliver too much radiation, so let’s screen for lung cancer instead.  But I don’t think so. This one actually makes sense, because the recommendation is for a targeted population of smokers (current and former).

Until we have eliminated smoking from the consciousness of the race, people will continue to become addicted to nicotine, and will continue to develop the horrifically devastating disease of lung cancer, and will continue to die agonizing deaths. When they stop smoking, the risk of cardiovascular disease quickly returns to the baseline of non-smokers. However, the risk of lung cancer continues for many years.

 

If a CT scan of the chest can detect potential disease in current or former smokers early enough to treat it surgically with reasonably anticipation of cure, then indeed the potential for saving lives is well worth the extra radiation delivered by the spiral CT scan. A 20% survival benefit far exceeds the measured 2% survival benefit obtained through routine mammography screening.