Silicone Implants Part 1

The FDA just lifted its ban on silicone implants. Instead of waiting for safety studies, they have decided to allow them back on the market with a “wait and see” attitude to see if any problems crop up. Supposedly, the FDA is supposed to hold off on the approval of drugs and medical devices until safety can be established. Although it seems more and more that they are allowing these drugs and devices to be put on the market and people being used as human guinea pigs. When the drugs are devices are found to be very dangerous or deadly the FDA often leaves them on the market, unless forced to remove them.

The safety of silicone implants has been in question for quite a long time. Back in the early 60s, both Dow Corning Wright (DCW), and the FDA, submitted interoffice memorandums admitting that the original breast implants could cause problems due to the polyurethane coating, which decomposed in the body in to the carcinogen TDA. Despite the danger, both DCW and the FDA did not remove these implants from the market, but rather stated that their use should be limited. The coated implants were eventually banned because of the danger of cancer from these type implants.

Though, the safety problems did not end there. Silicone implants have been suspected of causing a host of problems from autoimmunity to connective tissue disorders. Talking to women over the years with silicone implants, I have heard complaints suspected from the implants including skin disorders, chronic sinus infections, joint disorders, memory loss, etc. A personal friend of mine developed breast cancer in her right breast after her right silicone implant ruptured. She had the implants replaced with saline implants thinking they were safer. The cancer was eventually put in to remission with herbs and ozone therapy. When her saline implants started to leak she started developing malignant tumors all over her body. She sold her ozone unit to help cover her medical bills. I received a call one day from a mutual friend, and I was told that our friend was in hospice. She passed away shortly afterward. I have no doubt that the implants were a direct cause of her death.

Calcium from Coral

I do not recommend calcium from coral. Actually it is not much different from oyster shell, which is a lot cheaper. Both extract minerals and trace minerals from the water, and both are composed of calcium carbonate, which is a terrible form of calcium to be taking.

Coral is a colony of living animals, called polyps. As fish respirate they release carbon dioxide into the water, which reacts with calcium to form calcium carbonate. The polyps extract the calcium carbonate from the water to cement themselves to a hard surface. New polyps then cement themselves to the old dead polyps and the cycle continues causing the coral to grow. In the process other minerals are extracted from the water, but the primary component of coral still remains calcium carbonate.

The big problem with calcium carbonate is that it is very alkaline, and neutralizes acids. With the big push to alkalinize, this may sound good at first, but parts of the body need to be acid, and being too alkaline in the blood is also a problem. The biggest concern here is the stomach, which definitely needs to be acid. The stomach needs to be acid actually for several reasons. For instance in order to digest proteins the body uses an enzyme called pepsin. But pepsin cannot work without sufficient stomach acid being present. And vitamin B12 cannot be absorbed from the gut either, unless there is sufficient stomach acid. But stomach acid levels naturally decline with age, which is why B12 deficiencies are common in the elderly. Another problem is that many minerals cannot be absorbed unless there is sufficient stomach acid present, or unless they are pre-acidified, such as citrates, or reacted with other acids in the stomach, such as fruit acids or vinegar added to foods. Carbonates actually interfere with the absorption of minerals, like calcium, and even more importantly silica.

Silica is the most important nutrient for bone health, and is also essential for healthy hair, nails, teeth, tendons, ligaments, arteries, etc. Silica deficiencies are also responsible for wrinkle formation since silica is essential for elastin formation, which helps keep the skin from sagging.

Another very important purpose of stomach acid is to control the growth of microbes, such as bacteria and yeast in the stomach since most cannot tolerate a high acid environment. Therefore, as stomach acid levels decline the risk of infection increases. For example, the most common cause of heartburn is a lack of stomach acid leading to an overgrowth of stomach yeast. Fermentation from the yeast leads to a carbon dioxide build up in the stomach. The resulting pressure tires out the sphincter muscle at the top of the stomach and it gives way allowing the gas to escape up the esophagus. When this happens, traces of acid go with the gas causing the heartburn. Unfortunately the medical community is still stuck on the long outdated idea that excessive stomach acid causes heartburn, and they do not bother to read their own medical texts. Excessive stomach acid, a condition known as hyperchlorrhydria, is considered extremely rare. Yet antacids and acid blockers, which cover up the symptoms while making the underlying problem worse, are the second largest selling drug class. One of these compounds commonly used to neutralize stomach acid is calcium carbonate, such as Tums, and coral. Stomach acid is the first thing the carbonate in the coral is going to come into contact with making it more effective in alkalinizing the stomach than the blood. This is a real bad idea! The best way to get around this problem is to get your minerals from food or herbs. Minerals in plants are naturally chelated, which means they are bound to proteins. Being bound to proteins the body will accept these sources like foods, and the proteins help chaperone the minerals into the body where they are separated and can do their job of helping to reduce acids in the blood, not the stomach.

There are actually different chemical compositions in the corals taken from above the water and below the water. The below water coral has more nutrients; this is in part due to what else is in it. The below water coral is actually coral sand dredged from the bottom. Therefore, it not only is the broken down coral being sucked up, but also any little plants and animals in the sand. The above water coral has been weathered and leached of many of its minerals.

In short, there are better choices for calcium than coral. For instance if you want a great source of calcium and trace minerals then you could use Atlantic kelp, which not only contains these minerals, but also vitamins, which are not found in coral. Seaweeds contain algins, which bind with heavy metals such as those found in the coral, and the seaweeds themselves. By binding with the heavy metals algins pull these heavy metals from the body. Coral and colloidal minerals from shale deposits being sold as “plant derived” cannot do this.

Enviga

The Coca Cola Corporation has begun a joint venture with the Nestle Corporation to produce a new drink called Enviga. This green tea based beverage is claimed to be a “negative calorie” drink that will help burn calories. Enviga does have calories, actually 5 per can. The “negative calorie” claim must therefore be the belief that the drinks will burn more calories than it provides. Will the drink really help you lose weight though, and at what cost?

The manufacturers of Enviga claim that drinking 3 cans of Enviga a day will burn 60 to 100 calories per day. This is the equivalent number of calories of the average éclair, one cup of fat free ice cream, or 4 to 6 level teaspoons of sugar. In terms of fat, this equates to the loss of about of about 5 pounds over a year. Each can of Enviga costs an average of $1.40. Therefore, to lose that 5 pounds, if the drink really causes weight loss, would cost $1,533.00.

On the other hand, drinking a cold glass of water burns around 17 calories as the body burns calories to warm the water. Therefore, drinking 8 sixteen ounce glasses of cold water daily will burn 136 calories daily. In addition, drinking water not only helps to cleanse the system, but also suppresses the appetite. Both help reduce weight. A brisk walk burns 7 calories per minute. If it took 10 minutes to walk to the store to buy the Enviga, you would burn 70 calories, and another 70 calories on the way back. That is more calories burnt than by drinking 3 cans of Enviga. In addition, regular exercise helps to build muscle, which burns fat even when in a resting state.

Calories are not the only cause of weight gain though. So the real question is will Enviga help people lose weight. In my opinion, no it will not help people lose weight. In fact, it is more likely to cause weight gain than weight loss. To understand why, we must first look at the ingredients:

Carbonated water, calcium lactate, concentrated green tea from tea leaves, citric acid, phosphoric acid, potassium sorbate and potassium benzoate, natural flavors, Aspartame, caffeine, Acesulfame-K.

The only ingredient in Enviga that will have any real effect on weight loss is the green tea concentrate, and the added caffeine. Catechins in green tea have been found to help boost the metabolism, as does the added caffeine, and the caffeine from the tea extract. On the other hand, Enviga uses two artificial sweeteners, Aspartame, and Acesulfame-K. Not getting in to the other dangerous adverse effects of these two artificial sweeteners, both Aspartame and Acesulfame-K cause insulin spikes. Insulin in turn promotes fat production. In addition, Aspartame is also well known for causing weight gain because it promotes appetite. To further compound the problem, Aspartame can cause dry mouth syndrome increasing the likelihood that the person would drink even more Aspartame containing beverages, which can lead to further weight gain.

If you are really interested in losing weight, I recommend staying away from diet sodas and other diet drinks. Water is your best choice for a beverage, especially if you are diabetic.

Rogaine

Male pattern baldness (MPB) is characterized by the loss of hair primarily in the areas of the temples, and the top of the head. A more radical form of testosterone, known as dihydrotestosterone (DHT) is the trigger for MPB. DHT kills the hair follicles, which causes the hair to fall out. The temples and the top of the head are the primary targets for DHT because DHT receptors are concentrated in these areas.

The drug minoxidil, sold under the name Rogaine, was originally being tested as a treatment for high blood pressure. The drug works by dilating blood vessels. A noted side effect of the drug was increased hair growth in some of the test subjects. Therefore, minoxidil was then marketed as a hair loss remedy for both men and women.

Minoxidil works by increasing blood flow to the hair follicles. It does have some serious side effects though, including liver damage.

Increasing blood flow to the scalp to assist hair growth is hardly a new idea. People have long used irritating herbs, such as cayenne pepper, to stimulate circulation to the hair follicles. Brushing the hair, preferably with a boar bristle, or wood, brush also does a good job of stimulating scalp circulation. Scalp massage is probably the easiest method to stimulate blood flow to the follicles. Not only does it feel great, but it is free, and it does not damage the liver.

Keep in mind though that if the hair follicle is dead that increasing blood flow to the scalp will not bring it back to life. If there are still fine, living hairs present, then there is a chance to regrow the hair.

Polyheme Part 3

Cities listed as participants in the test are : San Diego, California; Denver, Colorado; Newark, Delaware; Macon, Georgia; Maywood, Illinois; Indianapolis, Indiana; Kansas City, Kansas; Lexington, Kentucky; Detroit, Michigan; Rochester, Minnesota; Durham, North Carolina; Cleveland, Ohio; Cincinnati, Ohio; Dayton, Ohio; Bethlehem, Pennsylvania; Hershey, Pennsylvania; Memphis, Tennessee; Johnson City, Tennessee; Houston, Texas; San Antonio, Texas; Salt Lake City, Utah; and Morgantown, West Virginia . The clinics and hospitals listed as participating were:

UC San Diego Medical Center, San Diego, California

Scripps Mercy, San Diego, California

Denver Health Medical Center, Denver, Colorado

Christiana Hospital, Newark, Delaware

Medical Center of Central Georgia, Macon, Georgia

Loyola University Medical Center, Maywood, Illinois

Wishard Memorial Hospital, Indianapolis, Indiana

Methodist Hospital of Indiana, Indianapolis, Indiana

University of Kansas Medical Center, Kansas City, Kansas

University of Kentucky Medical Center, Lexington, Kentucky

Detroit Receiving Hospital, Detroit, Michigan

Sinai Grace Hospital, Detroit, Michigan

The Mayo Clinic, Rochester, Minnesota

Duke University Medical Center, Durham, North Carolina

MetroHealth Medical Center, Cleveland, Ohio

University of Cincinnati Medical Center, Cincinnati, Ohio

Miami Valley Hospital, Dayton, Ohio

St. Luke’s Regional Resource Trauma Center, Bethlehem, Pennsylvania

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania

University of Tennessee-Memphis, Memphis, Tennessee

Johnson City Medical Center, Johnson City, Tennessee

University of Texas Health Science Center, San Antonio, Texas

University of Utah Health Sciences Center, Salt Lake City, Utah

LDS Hospital, Salt Lake City, Utah

Virginia Commonwealth University Medical Center, Richmond

West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West

Virginia

Other hospitals that stopped participating in the study before it was completed are the Albany Medical Center, Albany, New York; Lehigh Valley Hospital, Allentown, Pennsylvania; Brooke Army Medical Center, Fort Sam, Houston, Texas; Memorial-Hermann Hospital, Houston, Texas; Sentara Norfolk Hospital, Norfolk, Virginia; and Inova Fairfax Hospital, Falls Church, Virginia.

PolyHeme Part 2

In August of 2006, Northfield Laboratories tried to get accelerated approval for PolyHeme. The request was declined by the FDA until further study results come in. I guess they were in a rush since they signed a $6.7 million agreement on June 16th, 2006 to purchase a 106,000 square foot property that they intend to use to manufacture their product. This is really putting the cart before the horse since they don’t have approval for their blood substitute, nor is there any guarantee of approval.

This brings up the question of how far will Northfield Laboratories go to get their blood substitute approved to avoid losing their investment, and the money of their investors? After all, this has been a costly venture. Not only have they spent $6.7 million for the building they intend to manufacture their product in, but they are also paying the hospitals $10,000 for each patient they test the blood substitute on. Tack on to that other research and development costs, manufacturing equipment costs, and other expenses.

Pursuant to CFR 50.24 certain criteria must be met in order for testing to be performed on patients without their consent. For example, section (2) (ii) states “Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects”. So where are these previous animal or preclinical studies? The only study was halted early after a significant increase in deaths in patients receiving PolyHeme. Section (2) (iii) states “Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.” Again, the only clinical study was halted early because of a disproportionate death rate between those receiving PolyHeme, and those that did not. This is hardly reasonable, when standard therapy has been shown to be considerably safer and effective.

The regulation also requires that they try to gain consent prior to, or as soon as possible from a legal representative, such as a relative. From what I have seen, I don’t think this is being done. For instance, if a married couple is in an accident, and only one has sufficient trauma to require blood, are they obtaining consent from the spouse? It does not appear that they are. Instead, saline or PolyHeme were not chosen for the patient until the patient was on the way to the hospital. And according to news reports, the decision was based on sealed envelopes the paramedics opened in route to determine what treatment the patient would be given. Such a practice would prohibit the paramedics from explaining the risks and benefits to the spouse to allow them to make an informed decision, or give time to obtain consent even if the spouse was aware of the risks. If no legal representative can be found, then the company must provide proof of attempts to contact a legal representative.

Section (7) (ii) states “ Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits”.

The first problem with this is that Northfield Laboratories did not disclose the adverse effects of their product found in the 1998 study. In fact they threatened to sue the group that made the fact public claiming that the adverse effects, which included death, were part of their trade secret. I also see a problem with this regulation by the fact that everyone will not be aware of the study since not everyone follows, or has access, to the media. For example, the homeless would not likely know about the study, and therefore there will be no disclosure, as is required, to certain groups. Even though people in these groups may be subjected to the study. The law does allow life saving measures in people unable to give consent, such as unconscious patients. This is called implied consent. For instance, if a person tries to overdose on drugs to commit suicide and they refuse treatment, the paramedics cannot touch the patient. Once they pass out they can claim implied consent and start treatment. The basis is that the person, if they were conscious and able to give consent, would give consent to save their life. Does this apply to unapproved and untested drugs like PolyHeme though? I doubt if such an argument would hold up. A person would probably give consent if they knew, or had reason to believe, that the drug or treatment had been thoroughly tested and was an approved treatment. A reasonable person is not likely going to consent to an unproven, and potentially dangerous unapproved drug or treatment. Especially when safer and proven therapies exist. Northfield Laboratories claims to have followed CFR 50.24 explicitly. I disagree, based on the facts that they never completed previous trials, their product has a higher death rate than controls and those receiving blood, they have not informed the public of their testing, or the possible dangers of the therapy, and I don’t see any evidence that they are really trying to obtain consent as is required by law.

Patients were allowed to opt out of the test in case they suffered a severe trauma that would leave them unable to give consent. To do so though they had to obtain a blue plastic bracelet from the company that they had to be wearing at the time paramedics arrived. In order to get the bracelet the person would first have to be aware of the test. Many people were not aware that the test was going on until testing had almost been completed. And as previously pointed out, people that did not follow the media, or who had no access to the media, would have still been uninformed about the testing. The same could apply to those who do not speak English. Even if the story came on the TV news, it does not mean they would understand what the test was about, or how to opt out.

So what are the potential side effects of PolyHeme? Previous hemoglobin products have all been shown to cause kidney damage, liver damage, high blood pressure, and inflammation of the arteries. There is also concern that allergic reactions may occur. Northfield Laboratories claims that these adverse effects are not possible, and their product is safe. Other researchers disagree. And Northfield Laboratories has not had the greatest track record of being honest to the public about the safety record of their product. For instance when they tried to suppress the fact that 10 patients died within one week of receiving their product, and no patients receiving real blood died. And this study was halted early. Would more deaths have occurred if the study had continued its full duration? Other adverse affects reported by the use of PolyHeme were significant increases in the rate of heart attacks, arrhythmias, and pneumonia.

PolyHeme Part 1

Is it ethical to test people with experimental treatments without their knowledge or permission? This is what is in question after the FDA approved the testing of an artificial blood substitute, known as PolyHeme.

PolyHeme is a synthetic blood substitute derived from outdated, donated, human blood. Unlike human blood though, PolyHeme does not require blood typing or refrigeration. Another advantage of PolyHeme is that it can carry oxygen to the tissues, unlike blood volume expanders like normal saline. Shelf life is another advantage of the blood substitute. PolyHeme has a shelf life of 12 months, compared to real blood, which has a shelf life of about 42 days.

There are some serious safety issues with PolyHeme though. The first study of PolyHeme was started in 1998 and continued to the year 2000. In this study consent was obtained from patients as is required by law. The patients all had aneurysm surgery of the heart arteries. Ten of the 81 patients receiving the blood substitute died within a week, while none of the 71 patients receiving real blood suffered any heart attacks. This study was not only halted early because of the deaths, but the company who manufactures PolyHeme withheld the fact that people died during the study from the public.

In their most current study, Northfield Laboratories, the maker of PolyHeme, conducted a second study on over 700 patients, without their consent. Some patients receive PolyHeme alone, others received PolyHeme then saline, and the remainder received saline and blood. The study was conducted in various cities throughout the U.S. The FDA approved the testing without consent based on the 1996 Federal regulation CFR 50.24 waiver of informed consent.

The study started with a total of 722 patients. A total of 126 patients were dropped from the study due to what they called “protocol violations”. This includes patients that were too young, or they were excluded for other reasons. Other parameters that excluded patients included patients who have sustained unsurvivable injuries, have severe head injury, are pregnant, have cardiac arrest, or have objected to the study. Out of the remaining 586 patients, 279 were in the group receiving PolyHeme and 307 patients were controls. Incidences of death were higher in each of the groups receiving PolyHeme, compared to each of the control groups. Although, Northfield Laboratories claims that the difference in the number of deaths was not significant.

Northfield Laboratories tried to get FDA approval based on previous studies of trauma patients. The other patients they were comparing had not had blood though. They were trauma patients that had not received blood because of religious beliefs.

Sinus Infections

One of the most common mistakes I see doctors make is the prescribing of antibiotics without first performing a culture. This is especially true for sinus infections. Time and time again I have seen people given antibiotics for sinus infections without a culture. The majority of the time antibiotic therapy fails. The problem is that antibiotics work against bacteria, though the majority of sinus infections are fungal in origin. If a fungal infection is present in the sinuses, antibiotic therapy will not only fail, but the therapy will make the condition worse. The sinuses, like various other parts of the body, contain beneficial bacteria. These bacteria, among other functions, help to control fungal overgrowth. As antibiotics kill off the beneficial bacteria, the fungal infection becomes free to grow uncontrolled.

Fungal infections of the sinus cavity are actually extremely difficult to eradicate. My former business partner suffered with a fungal sinus infection for seven years when I met him. He was prescribed antibiotics over and over without any success. A few doctors did run cultures, though the cultures failed to show infection. I made him a concoction of osha’ root, cayenne pepper, and licorice root. The next day a large fungus ball came out of his sinuses. Analysis by a medical lab determined that the infection was a very aggressive black fungus. The constant antibiotic therapy just increased the hold the fungus had in his sinus cavity.

Further complicating the problem is the fact that the sinus cavity is a warm, moist environment. This is the perfect growing environment for fungus. When trying to fight fungal infections, two problems arise. First, any fungus being killed can become food for the surviving fungus. Second, if even one fungal spore remains the infection may rebound.

Many feel the best way to address sinus infections is to first get a culture so the type of infection is known. If the infections are proven to be bacterial, pharmaceutical or herbal antibiotics, such as pau d’ arco, are recommended. Fungal infections are best addressed by trying to restore the flora in the sinus cavity. Probiotic supplements, or probiotic foods, such as yogurt or kefir, can help. A probiotic powder, such as acidophilus powder, may be made into a liquid, with the addition of distilled water, for nasal irrigation, or snuffing. This will help elevate levels of beneficial bacteria in the sinus cavity. Eating horseradish may also help. Horseradish root contains a volatile oil, with extremely strong antiseptic properties. When ingested, the oil is absorbed into the bloodstream, and excreted through the respiratory passages. By trying to breathe through the nose, the oil is forced up into the sinus cavity where it can help fight infection.

Limiting the intake of simple sugars, high glycemic foods, and yeast products may also help. Consumption of alcohol and caffeine should also be eliminated.

Maintaining a healthy immune system is also essential. A few suggestions are the herbs amla berry, schisandra berry, astragalus, jiaogulan, and myrrh. Other recommended supplements include 50 mg of zinc daily, 200 micrograms of selenium three times a day, and 10,000IU daily of vitamin A. Vitamin C is important, though excessive doses are not recommended. Natural sources of vitamin C are more effective than synthetic forms. This is why I recommend amla berry, which is my favorite source of natural vitamin C.

Does the Sun Cause Cancer

Does the sun cause cancer? That is the question. Unfortunately, there is no clear answer.

The medical profession, and the media, have done a good job of convincing the public to stay out of the sun to prevent cancer. But, is there any evidence for this claim? Surprisingly, evidence is lacking. Furthermore, there is evidence to the contrary.

Considering a large number of people that are exposed to the sun on a daily basis, for an extended period of time, we would expect to see a pandemic of skin cancer. This obviously is not happening. Athletes and construction workers would be good examples. Yet, there has not been an abnormally high level of cancer occurrence in these groups. An increase of cancer has been reported in migrant farm workers, primarily on the back of the neck. Although, this increased of cancer has not been attributed to the sun, but rather exposure to herbicides and pesticides.

Sun exposure actually has beneficial effects on the immune system, such as activation of macrophages. In addition, sunlight reacts with cholesterol in the skin to form of vitamin D, which has been shown to have strong antitumor affects. The production of active vitamin D decreases with age though. This could help partially explain the increased risk of cancer with age.

Ironically, it may be the sunscreens being used in an attempt to protect the skin that may be increasing the risk of cancer. Sunscreens often contain chemicals that are known carcinogens.

MSM

MSM (methyl sulfonyl methane) hit the market as a multi level marketing (MLM) product about 10 years ago. As with other MLM products, it was promoted with a lot of hype and misinformation. What are the facts behind MSM?

MSM contains 34% sulfur by weight. Elemental sulfur is produced as the MSM is metabolized.

Commercial MSM is not natural. I had an MLM saleslady actually tell me that MSM was natural because it was derived from trees. This is really stretching it. MSM is created by the heating of the industrial solvent DMSO (dimethylsulfoxide). When DMSO is heated an oxygen atom attaches forming DMSO2, which is also known as MSM. DMSO is actually a byproduct of the paper industry, but this does not make DMSO natural either. Many plastics are synthesized from natural compounds, but this does not make plastics natural. When a chemical is altered by man to make a new chemical then the new chemical is not natural, it is synthetic.

Sulfur is essential to the body, although deficiencies are almost unheard of. Sulfur is found in numerous foods we eat including garlic, onions, peppers, broccoli, beans, seaweeds, etc.

Sulfur is used in the production of proteins and hormones. For example, sulfur aids in the formation of the proteins collagen, elastin, and keratin. Collagen gives connective tissues strength, while elastin gives the tissues their elasticity. Keratin is the primary protein founding hair and nails. Therefore, sulfur aids in the growth of hair and nails. It is commonly thought that sulfur aids in strengthening the hair and nails, though silica, in the form of orthosilicic acid, is the primary compound that strengthens the hair and nails. The hormone Insulin requires sulfur for its production. Insulin is required for the regulation of blood sugar and the transport of vitamin C to immune cells. Sulfur compounds also aid in the detoxification of the body.