Medical & Dental Health Topics

When Did Pharmaceutical Drug Prices Begin Rising?

2015-02-15T00:01:00.000-05:00

I'm sure we all know that in order for a pharmaceutical company to stay in business, it needs to make a profit. The way a pharmaceutical company makes a profit is by increasing drug prescriptions. It actually depends on who you talk to find out when drug prices were actually increasing.

Some claim that the U.S. “health care cost crisis” didn’t start until 1965.

The government increased demand with the passage of Medicare and Medicaid while restricting the supply of doctors and hospitals. By 1968, these new government programs had caused healthcare-related spending nationwide to skyrocket and to become a major political concern.

Others claim that it was not until 1991.

A time of intensified scrutiny by policymakers didn't happen until 1991. That was when the American Medical Association (AMA) issued ethics guidelines addressing pharmaceutical marketing and industry gifts. Since that time, attention to pharmaceutical marketing has surged as marketing has intensified and drug prices have risen. In response, the Pharmaceutical Research and manufactures of America (PhRMA) issued voluntary guidelines in 2002. while the AMA published addenda to their original guidelines around the same time

Under both guidelines, gifts valued less than $100 are allowed if they primarily entail a benefit to patients or are associated with a physician’s practice. Meals for physicians are acceptable if they are modest and are provided in association with an educational component.

The code states that gifts worth $100 or less may be given only if they are directed at patient education or other patient benefit , according to the Journal of the National Cancer Institute (JNCI). What that means is an anatomical model or toothbrushes or medical supplies, such as a first responder kit or sphygmomanometer are OK, but VCRs and golf clubs are not. If a presentation and discussion that provides valuable educational benefit, a modest meal can be offered.

Attempts to control drug prices in the United States is backfiring.

It all sounds reasonable, but a company has to make money. If they have to reduce something to survive, they will. They would rather not reduce quality or employees, so what is there for them to do. Whenever the government sets prices, rules and regulations, it has predictably led to reduced quality and rationing. Moreover, the bureaucracy has brought standardized care, higher administrative costs and high executive salaries.

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How is Coal Related to Medical Products?

2015-02-01T00:01:00.000-05:00

Yes, I'm talking about coal. That black or brownish-black solid combustible substance, widely used as a natural fuel. The same coal that is mined in the ground. The same charcoal that is created by cured wood that has been burned for hours.

Psoriasis in the scalp, palms and soles, and areas where two skin areas may touch or rub together differ from disease on other body parts because of the presence of hair.

Psoriasis in some body parts can be challenging to treat, cites Mount Sinai Medical Center in New York. Treatment procedures must be adapted to these areas. The scalp is actually a challenge to treat. However, coal seems to have solved this problem. Coal tar shampoo works great and so does this anti-dandruff coal-tar shampoo.

The Food and Drug Administration (FDA) has approved coal tar used for medicinal purposes that is obtained as a byproduct during the destructive distillation of bituminous coal at temperatures in the range of 900 degrees. Celsius to 1,100 degrees. Celsius. Coal tar is used to treat eczema, psoriasis, seborrheic dermatitis, and other skin disorders, according to the Mayo Clinic. Used topically, this coal tar cream relieves drying, itching, flaking, scaling, or irritation of the skin even better than this non-coal tar cream.

Coal tar or crude coal tar is obtained by the destructive distillation of bituminous coal at very high temperatures.

Princeton University states that bituminous coal or black coal is a relatively soft coal containing a tarlike substance called bitumen. It is is usually black, sometimes dark brown, often with well-defined bands of bright and dull material.

The National Psoriasis Foundation recommends coal tar. Tar can help slow the rapid growth of skin cells and restore the skin's appearance. In addition, it can help reduce the inflammation, itching and scaling of psoriasis.

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Do You Get More Nicotine From A Puff of an E-Cig or Cigarette?

2015-01-15T00:01:00.001-05:00

E-cigs are increasingly popular. At first, we were not sure if electronic cigarettes even contained nicotine. That is not the case anymore, since we know that they do contain nicotine. Now, we want to know more about the smoke that is inhaled from these cigarettes.

There are many factors determining how much nicotine one of these smokers inhales.

The aerosol resulted from heating a solution containing nicotine is what an electronic cigarette smoker inhales. Not much is known about a user's puffing behavior nor the amount of nicotine that the mouthpiece allows one to inhale.

According to a study by the Center for the Study of Tobacco Products in the Department of Psychology at Virginia Commonwealth University and the American University of Beirut, the extent to which a mouthpiece influences nicotine delivery and subjective effects in ECIG users is unknown.

A new term has been created to determine the amount of nicotine inhaled and that term is "puff topography".

Depending on puff conditions and product features, 15 puffs from an ECIG can provide far less or far more nicotine than a single tobacco cigarette.

The Onassis Cardiac Surgery Center at Kallithea, Greece sees things a bit differently. Their study uses four-second puffs with 20-30 s interpuff interval, which they say should be used when assessing electronic cigarette effects in laboratory experiments, provided that the equipment used does not get overheated. Based on the characteristics of the device used in this study, a 20 mg/mL nicotine concentration liquid would be needed in order to deliver nicotine at amounts similar to the maximum allowable content of one tobacco cigarette.

It all depends on puff conditions and product features.

Depending on puff conditions and product features, 15 puffs from an ECIG can provide far less or far more nicotine than a single tobacco cigarette. That makes a whole lot of sense. That statement doesn't really mean anything. The Food and Drug Administration has provided a document for reference purposes on two e-cig products, Njoy e-cigarette with various cartridges and Smoking Everywhere Electronic Cigarette also with various cartridges. http://www.fda.gov/downloads/drugs/Scienceresearch/UCM173250.pdf

In this document, levels found were consistent with the labeling (low, medium and high); however, the cartridge labeled “no” still delivered some nicotine. The cartridges labeled “high” delivered more nicotine than the approved Nicotrol product. Repeat testing of 3 different cartridges with the same label (menthol high) gave varying results from 26.8 to 43.2 mcg nicotine/100 mL puff.

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Was It That Long Ago That an Ebola Vaccine Was Actually Introduced?

2015-01-01T00:00:00.000-05:00

Ebola virus, being highly pathogenic for humans and non-human primates and the subject of former weapons programmes, is now one of the most feared pathogens worldwide, states the Department of Medical Microbiology at the University of Manitoba in Canada.

As early as 2000, we knew it was possible to develop an Ebola vaccine.

The Vaccine Research Center, National Institutes of Health, Bethesda, Maryland described a highly effective vaccine strategy for Ebola virus infection in non-human primates. It was challenged with a lethal dose of the highly pathogenic, wild-type, 1976 Mayinga strain of Ebola Zaire virus resulted in uniform infection in controls, who progressed to a moribund state and caused death in less than one week. It was a different with all vaccinated animals who were asymptomatic for more than six months, with no detectable virus after the initial challenge. These findings from this study demonstrated that it is possible to develop a preventive vaccine against Ebola virus infection in primates.

In 2003, perspectives were changed regarding an Ebola virus because of September 2011 events.

The Virology Division at the United States Army Medical Research Institute of Infectious Diseases looked at current Ebola vaccine candidates since the heightened awareness of bio-terrorism advanced by the events surrounding September 11, 2001, concomitant with knowledge that the former Soviet Union was evaluating Ebola virus as a weapon, has dramatically changed perspectives regarding the need for a vaccine against Ebola virus. They stated that the Ebola viruses belong to the family Filoviridae, which are among the most virulent infectious agents known.

In 2006, we developed a vaccine against the Ebola virus for rodents.

The Division of Biodefense Vaccines, GenPhar, Inc performed a study demonstrates the potential efficacy of a bivalent Ebola (EBOV) vaccine based on a cAdVax vaccine vector design. The National Institute of Allergy and Infectious Diseases in Maryland actually funded a study that a DNA vaccination conferred an Ebola virus-specific immune response in guinea pigs and mice. This study also indicates that a protection against a challenge with Ebola virus was adapted to produce a lethal infection in rodents.

In 2009, a Ebola vaccine was developed to protect a cynomolgus monkey.

The Food and Drug Administration requires the use of a non-rodent species, often the dog or monkey because of similarities to specific human biochemical pathways. The non-rodent animals that are considered standard models for toxicology studies include rabbit, dog and monkey, specifically the New Zealand White rabbit, the beagle dog and the cynomolgus monkey. Because these animals have been traditionally used, there is substantial accumulation of historical data and the use of a different animal model could delay approval of a new drug.

At this time, the Department of Microbiology, National Emerging Infectious Diseases Laboratories Institute at the Boston University School of Medicine developed an immunization scheme based on a single-injection vaccine that protects nonhuman primates against lethal challenge with representative strains of all human pathogenic filovirus species.

In 2010, at least four systems have shown the ability to protect non-human primates against lethal Marburg virus and Ebola challenges

A report, from the Virology Division, United States Army Medical Research Institute of Infectious Diseases provided the first demonstration of vaccine-induced protective immunity against challenge with a heterologous EBOV species, and shows that Ebola vaccines capable of eliciting potent cellular immunity may provide the best strategy for eliciting cross-protection against newly emerging heterologous EBOV species.

In 2013, evidence was provided that proved that the Ebola virus infection in wildlife came from mainland Asia and confirms that filoviruses are harbored across a much larger geographic range then assumed.

The Emerging Viral Pathogens Section at the National Institute of Allergy and Infectious Diseases, National Institutes of Health did a study with mice where the results further support the concept that a successful EBOV vaccine needs to induce strong antibodies against EBOV.

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What Effect Does Wine Have on Your Oral Health?

2014-12-15T00:01:00.000-05:00

We have heard for years how beneficial to your health it is for you to consume wine. There are even studies to prove that.

Red wine may help prevent heart disease.

For instance, the Mayo Clinic says The alcohol and certain substances in red wine called antioxidants may help prevent heart disease by increasing levels of high-density lipoprotein (HDL) cholesterol (the "good" cholesterol) and protecting against artery damage.

The Yale-New Haven Hospital adds that men will benefit from consuming one to two servings per day. Women should consume only one serving per day to reap the maximum benefits.

So, red wine is good for your heart, but has anyone ever asked a dentist or a dental school how they think wine affects your oral health.

Dental erosion, caused by wine, depends on the length of exposure of the wine on the teeth.

The occurrence of tooth surface loss amongst winemakers was highly likely due to frequent exposure of their teeth to wine found the Department of Community Health, Faculty of Health Sciences, University of Stellenbosch in South Africa in a study of thirty-six people, twenty-one of them being winemakers and fifteen of them being their spouses.

According to School of Dentistry and Oral Health, Griffith University in Australia, the study they did among professional wine tasters indicates that the degree of dental erosion seen amongst professional wine tasters depends directly on the length of exposure rather than on the actual sips per day.

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What About The Drugs That Break the Addiction to Narcotics?

2014-12-01T00:01:00.000-05:00

Several types of medications have been used for stabilizing heroin users. They are Methadone, Buprenorphine and levo-alpha-acetyl-methadol (LAAM.), according to the Scientific analyst Best practice, Interventions, laws and policies unit of the EMCDDA in Lisbon Portugal.

Buprenorphine, is a preferred drug that helps break the cycle of addiction to heroin and other narcotics.

Pharmacological effects of a buprenorphine injection occur as soon as 15 minutes after intramuscular injection and persist for 6 hours or longer. Buprenorphine and the combination of buprenorphine and naloxone come as sublingual tablets to taken under the tongue.

Buprenorphine is more weakly addictive and has a lower risk of overdose than methadone. The effects of buprenorphine last for about three days. According to the Turning Point Alcohol and Drug Centre, in Victoria, Australia found that LAAM appears more effective than methadone at reducing heroin use. More LAAM patients than methadone ceased their allocated medication during the studies, but many transferred to methadone and so the significance of this is unclear.

Methadone has steadily gained popularity as a therapy for moderate-to-severe chronic pain.

Methadone is a synthetic opioid often prescribed for the detoxification of and maintenance therapy for patients with narcotic addiction. Since 2006, the Food and Drug Administration, (FDA) has reviewed reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. Because of this, methadone (Dolophine, Roxane) is a bit controversial. Healthcare professionals should tell patients to take no more methadone than has been prescribed without first talking to their physician.

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Does Cannabis Use Affect Your Oral Health?

2014-11-15T00:01:00.001-05:00

Tobacco smoking is recognized as a behavioral risk factor for periodontal disease and cannabis smoking may contribute in a comparable way. I say "may" as there are very few studies on how cannabis smoking affects your oral health. Of the studies that I have found, they are all done outside of the U.S.

Smoking marijuana may cause periodontal disease.

At the Department of Oral Sciences, Sir John Walsh Research Institute, School of Dentistry in New Zealand, there were three cannabis exposure groups out of 903 individuals. 293 individuals, or 32.3% had no exposure to cannabis, 428 individuals or 47.4% had some exposure to cannabis and 182 individuals or 20.2% had high exposure to cannabis. It does appear that the high exposure to cannabis group had 23.6% periodontal disease, where the low cannabis exposure group had 6.5% periodontal disease and the moderate cannabis exposure group had 11.2% periodontal disease. The conclusion was cannabis smoking may be a risk factor for periodontal disease that is independent of the use of tobacco.

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Together the Department of Periodontology at Bhojia Dental College, the Department of Periodontics and Community Dentistry at Aligarh Muslim University, and the Department of Orthodontics and Dental Anatomy at Aligarh Muslim University published a paper indicating that Cannabis smoke acts as a carcinogen and can cause premalignant lesions in the oral mucosa with oral side effects are xerostomia and leukodema. Xerostomia is a dry mouth and leukodema is a diffuse, gray-white, milky opalescent appearance of the mucosa which usually occurs bilaterally on the inside of the cheeks and is a very common harmless condition.

Smoking marijuana may not cause periodontal disease.

According to the Department of Periodontology, School of Dentistry at the University of Aarhus in Denmark, a study they did among Chilean high school students from the Province of Santiago indicated that there was no evidence to suggest that the use of cannabis is positively associated with periodontal diseases in this adolescent population.

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What Material is Placed in Your Jaw for a Dental Implant?

2014-11-01T17:59:00.000-04:00

A typical dental implant procedure is when a person has lost a single tooth and wants to have it replaced. It is a better procedure than a bridge because a bridge involve drilling and shaving off the teeth of either side of the missing tooth, where a dental implant has very little effect on the teeth on either side of it. A dental implant will require a crown supported by a dental implant.

In many situations, the tooth has been missing for several years and there is not enough bone to support the implant. A variety of procedures used to "build" bone so that dental implants can be placed is called "bone augmentation".

A procedure of a dental implant typically involves grafting or adding bone or bonelike materials to the jaw.

The material making the graft can be taken from the patient's chin or from a cadaver to "rebuild" the lost bone so that it can support an implant. This type of procedure is done in the surgeon's office under intravenous (IV) sedation. Synthetic materials are man-made materials made from chemicals and they also can be used for bone grafting. Newer products, such as bone morphogenetic protein-2 (BMP-2), also are available.

BMP-2 occurs naturally in the body and stimulates certain body cells to turn into bone, without grafting.

According to as study by the Department of Periodontics Dental School at the University of Texas Health Science Center, after 4 weeks, the BMP-2-treated sites had a significantly higher percentage of contact, more new bone area, and higher percentage of defect fill than the sites without BMP-2. However, the addition of collagen encourages the healing effect to be better after 12 weeks. Collagen is the most abundant protein in mammals, accounting for around 30% of the protein content of the human body. It is often considered to be the "glue that holds the body together", according to medicalnewstoday.com.

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Does Drinking Alcohol Increase the Risk of Alzheimer's Disease?

2014-10-15T00:01:00.000-04:00

Alzheimer's disease is one form of dementia that gradually gets worse over time. It affects memory, thinking, reasoning and behavior. According to the National Institute on Aging (NIH) alcoholism or a person that tends to drink heavy increases the chances of Alzheimer's:
Alcohol Use and the Risk of Developing Alzheimer's Disease

Alcohol could be linked to Alzheimer's Disease.

The National Institute on Alcohol Abuse and Alcoholism states that, both alcohol and Alzheimer's Disease substantially affect the cholinergic system, and thus it is plausible that alcohol use could be linked to Alzheimer's Disease through their common effects on this system. Early studies of Alzheimer's Disease from the 1980s focused on the cholinergic system because it was known to play an important role in memory. The cholinergic system contain nerves that are stimulated by acetylcholine, which is a neurotransmitter released by nerves that is essential for communication between the nerves and muscles.

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Korsakoff syndrome is a chronic memory disorder caused by severe deficiency of thiamine (vitamin B-1), according to the Alzheimer's Association. Even though Korsakoff syndrome is most commonly caused by alcohol misuse, it can also be associated with AIDS, chronic infections, and poor nutrition. Other causes of Korsakoff syndrome include, anorexia, overly-stringent dieting, fasting, starvation or weight-loss surgery, kidney dialysis, chronic infection, or cancer that has spread throughout the body.

Moderate alcohol consumption may reduce the risk of Alzheimer's Disease.

Conversely, there are studies that state moderate consumption of alcohol may reduce the risk of Alzheimer's. WEBMD has information that moderate Alcohol Drinking May Cut Alzheimer's Risk.

Information changes all the time. One minute coffee is bad for you, then it's good for you. The next time alcohol increases the risk of Alzheimer's, the next time it reduces the risk. It may very well be the amount of alcohol you drink and the frequency, but the studies I found did not state that.

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What Causes Ringing In The Ears?

2014-10-01T00:01:00.000-04:00

The Mayo Clinic says that Tinnitus (TIN-ih-tus) is noise or ringing in the ears. Tinnitis is very common and may affect 20% of the population of the U.S. Approximately 50 million US adults reported having any tinnitus, and 16 million US adults reported having frequent tinnitus in the past year.

Medications may cause tinnitus.

Apparently, there are more than 200 drugs are known to cause tinnitus when you start or stop taking them. The FDA-mandated package insert printed in plain black type on both sides of a folded sheet of white paper that comes with medications will provide extensive drug information for physicians and pharmacists and if you can read the teeny tiny writing, you will find that it will give you known side-effects for each medication. Harvard Health Publications instruct that the package insert’s catalog of side effects is hard to assess. “Adverse Reactions” includes every side effect reported during the drug’s clinical testing, and, when appropriate, the side effects of other drugs in the same class.

Health changes may cause of tinnitus.

The National Institute on Deafness and Other Communication Disorders gives a few causes for tinnitus.

Noise-induced hearing loss
Ear and sinus infections
Diseases of the heart or blood vessels
Ménière’s disease
Brain tumors
Hormonal changes in women
Thyroid abnormalities

The prevalence of frequent tinnitus is highest among older adults, non-Hispanic whites, former smokers, and adults with hypertension, hearing impairment, loud noise exposure, or generalized anxiety disorder finds the Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.

Stress may cause tinnitus.

There appears to be many, many causes of tinnitus, but few studies note that stress may be a factor. The Department of Otorhinolaryngology, Faculty of Medicine at Minia University in Minia, Egypt did take note of this. Their study stated that depression, anxiety and stress should be taken into consideration in the treatment of patients suffering from tinnitus. There is a direct correlation between duration of tinnitus and severity of stress. I believe people know when they are under stress and they, themselves, can reduce the stress. However, they may not want to change what is causing them stress. People have to focus on their health and eliminate stress causing factors.

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Is Your Muffin Top Caused from Sugar Sweetened Beverages?

2014-09-15T00:01:00.000-04:00

A couple of years ago, the Division of Epidemiology and Community Health, School of Public Health, University of Minnesota found that increased frequency of sugar-sweetened beverages consumption is associated with a more adverse abdominal adipose tissue deposition pattern. This appears to be one of the main causes of the famous muffin tops that the teen and twenty year olds are so proud to have.

Sugar sweetened sodas are the cause of overweight young adults.

The University of Minnesota, however, is not the only place that has confirmed that non-diet sodas are a main cause of overweight young adults. Sugar-sweetened beverages are the single largest source of added sugar and the top source of energy intake in the U.S. diet and decreasing sugar-sweetened beverages in the diet will reduce obesity according to the Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA.

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Numerous hospitals in Massachusetts got together to jointly confirm that emerging evidence suggests that greater intake of sugar-sweetened beverages may be associated with abnormal fat accumulation in visceral adipose tissue. The MA Division of Endocrinology and Metabolism at the University of Massachusetts Medical School, the Department of Medicine at Brigham and Women's Hospital, Harvard Medical School, and the Energy Metabolism Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University conducted a cross-sectional analysis using previously collected data in 2596 middle-aged adults and they found that daily consumers of sugar-sweetened beverages had a 10% higher absolute visceral adipose tissue volume and a 15% greater visceral-to-subcutaneous adipose tissue ratio compared with non consumers, whereas consumption of diet soda was not associated with either volume or distribution of visceral adipose tissue.

The greatest proportion of weight increase is seen among Non-Hispanic black and Mexican-American women.

Not only is your muffin top caused by sugar sweetened beverages, but according to a study among multiple hospitals, the consumption of sugar sweetened beverages is associated with higher blood pressure, leading to increased incidence of hypertension.

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Is The Risk Of A Stroke Associated with SNUS?

2014-09-01T00:01:00.000-04:00

There has been considerable debate on whether smokeless tobacco has any effect on cardiovascular disease. Over a decade ago, the International Health Research Group, Liverpool School of Tropical Medicine, located in Liverpool England, states that there may be an association between smokeless tobacco use and cardiovascular disease. The indecisive word is "may." Although, there has always been a need for a larger sampling to confirm this.

More than 61 million people in the United States suffer from some form of cardiovascular disease, including high blood pressure, coronary heart disease, stroke, congestive heart failure, and other conditions.

SNUS use definitely has a short-term effect on the cardiovascular system.

The relationship between SNUS use and a stroke is unclear. There are two broad categories of stroke: those caused by a blockage of blood flow and those caused by bleeding into the brain. The National of Neurological Disorders and Stroke put cigarette smoking as one of the most important treatable risk factors for a stroke. In 2009, the Karolinska Institutet found that, overall, there was no association between use of SNUS and risk for cardiovascular disease. Their data did not support any strong association between SNUS use and risk for cardiovascular disease.

Any circulatory disease risk from smokeless tobacco appears to be substantially less than from smoking, and no clear risk from Swedish snuff is seen, according to PN Lee Statistics and Computing Ltd., in Surrey, UK, a company that offers expert advise on statistical and computing issues, as well as, being involved in clinical trials with many companies.

Nicotine is unlikely to contribute to the possibility of a stroke.

According to a more recent study at the Department of Public Health Sciences at the Karolinska Institutet in Sweden, the use of SNUS was not associated with the risk of stroke, however, case fatality was increased in SNUS users, compared with nonusers. This case fatality indicates that the use of snus may be associated with a higher risk of heart failure, according to the Department of Medical Sciences at Uppsala University.

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Unbelievable Ways You Can Get A Salmonella Infection?

2014-08-15T00:01:00.000-04:00

Within the last few years, Salmonella infection has been a major concern. Although anyone can get a Salmonella infection, according to the Center for Disease Control, CDC, children younger than 5 years, older adults, and people with weakened immune systems are at increased risk for serious illness. In these people, swallowing a relatively small number of Salmonella bacteria can cause severe illness.

In food-producing animals, antibiotics are widely used.

According to data published by the Food and Drug Administration, FDA, more antibiotics are sold nationally for food-producing animals than for people. These antibiotics contribute to the rise of antibiotic-resistant bacteria in food-producing animals. This bacteria has been found in chicken. To eliminate Salmonella in chicken, we need to wash hands with warm soapy water for 20 seconds, separate raw chicken from other foods, cook chicken internally to 165 degrees Fahrenheit, and keep food chilled within one to two hours outside of a refrigerator.

You can also get Salmonella from perfectly normal-looking eggs. Salmonella can live on both the outside and inside of eggs that appear to be normal. Because chicken feces on the outside of egg shells used to be a common cause of Salmonella contamination, in the 1970s, regulators put strict procedures into place for cleaning and inspecting eggs. Now, if Salmonella is found on the inside of eggs; it gets there as the egg is forming, it cannot squeeze through the shell.

You may think you are safe from salmonella if you take these precautions against chicken or if you are a vegetarian.

Not so fast. It has been found that those cute little pet turtles commonly carry bacteria called Salmonella on their outer skin and shell surfaces. Actually, lizards, snakes, amphibians, frogs, salamanders, and newts also carry Salmonella.

People who usually get Salmonella infections are infants, young children, elderly people, and people with lowered natural resistance to infection due to pregnancy, cancer, HIV/AIDS, diabetes, and other diseases.

Surfaces such as countertops, tabletops, bare floors, and carpeting can also become contaminated with the bacteria if the turtle is allowed to roam on them. The bacteria may survive for a long period of time on these surfaces, according to the FDA.

Because young children are more vulnerable to the effects of Salmonella, since 1975, FDA has banned the sale of turtles with a shell less than four inches long.

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What Actions Can Be Taken by the FDA Against Pharmaceutical Companies?

2014-08-01T00:01:00.000-04:00

During an inspection of a pharmaceutical company by the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) investigators may observe conditions they deem to be objectionable. The FDA does not need to find a defective tablet, nor does a death nor sickness have to develop. The FDA does not even have to hear of a complaint.

Objectionable Condition

These observations, are listed on an FDA Form 483. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD and C) Act and related Acts. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection.

Pharmaceutical companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist. The FDA can issue a Form 483 if Good Manufacturing Processes (GMP) are not followed.

Warning Letter

The FDA can take the following actions during a faulty inspection of a pharmaceutical company. First they can issue a warning letter.

There are three types of Warning Letters on the FDA Website:

Next a seizure of goods or the offending drug(s). If there is concern that the product will be distributed before seizure can be effected, FDA will determine if the dealer will voluntarily hold the product or if an embargo will be necessary. The FDA uses the terms “mass” and “open-ended” to distinguish these seizures from “lot-specific seizures,” in which a specific lot or batch of a product is seized.

Injunction

An injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. Once a complaint for injunction is filed by the United States, a hearing may be placed on the court calendar at any time, this court time could even take place with extremely short notice.

When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendants fail to obey the terms of the official order or decree. Should the decree be violated, the agency must consider a civil or criminal contempt of court, or other regulatory action, in as timely a manner as used in initiating the injunction. It is, therefore, mandatory that FDA personnel responsible for initiating injunctions also adhere to the implementation procedure in “Compliance Follow-up."

Debarment

The last step is debarment. Under its statutory debarment authority, the agency (FDA) may also ban, or “debar” from the drug industry individuals and companies convicted of certain felonies or misdemeanors related to drug products. Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.

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What is a Very Quick Overview of Drug Regulation?

2014-07-15T00:01:00.000-04:00

Drug regulation is strictly regulated in the United States. Title 21 Code of Federal Regulations (CFR) Parts 210 and 211 contain the minimum Current Good Manufacturing Practices (cGMP) regulations for drug manufacturing processing and packaging according to the Food and Drug Administration (FDA). These regulations are the Rule Book for pharmaceutical companies and they tell the drug companies what they have to do, but not necessarily how to do them.

Written Procedures for Production

Among all these regulations, drug companies must have written procedures for production and process controls to ensure drug products have specified identity, strength, quality and purity. Part 211.100 states that these procedures have to be ensured by the drug companies quality assurance and quality control departments. These written procedures must be followed and the process control functions must be recorded at time of completion. Any deviations from these procedures must be recorded and justified.

Labeled Containers

Containers must be be labeled with name, item code, control number, batch for which component was issued, including name, weight or measurement in new container, strength and and lot number and not less than 100% of the labeled or established amount of active ingredient according to Part 211.101.

Verification of Quality Control Procedures

The quality control process is very strict in that any and all procedures must be verified by a second person. The procedures for a development of a drug as simple as an over-the-counter aspirin could take as many as 14,000 signatures.

Finished Operations Examination

According to 211.134, packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label and a representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.

You may think all of these rules are common sense and should be followed, but if a single procedure is missed or not followed, these errors cost the pharmaceutical company. If you have ever wondered why drugs cost so much to develop, the FDA regulations are a good reason.

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Is Heroin Addiction Accociated With Other Serious Health Conditions?

2014-07-01T00:01:00.000-04:00

Heroin addiction is a serious health problem since there is a high tendency to relapse after periods of addiction. SFGATE, the San Francisco Chronicle, states that heroin users are on the rise, increasing numbers of addicts are looking for help but are failing to find it — because there are no beds in packed facilities, treatment is hugely expensive and insurance companies won't pay for inpatient rehab.

Addiction

The Cleveland Clinic describes addiction as compulsions to use and abuse things to an excessive and destructive extent. The American Medical Association has determined that alcoholism and drug addiction are both recognized as diseases. It is generally known that compulsive use and relapse are associated with heroin craving which is very influential in the addiction process.

According to the National Institute on Drug Abuse, heroin abuse is associated with a number of serious health conditions, including fatal overdose, spontaneous abortion, and infectious diseases like hepatitis and HIV. Chronic users may develop collapsed veins, infection of the heart lining and valves, abscesses, constipation and gastrointestinal cramping, and liver or kidney disease.

Behavior

It is easy to blame others for all our problems and psychologists have argued that people have more control over their behavior than they seem to realize. Addiction is a behavior and behaviors have choices as cigarette smoking and over eating.

Almost all private health care policies include either partial or full coverage for substance abuse services allowing coverage of up to 30 days. The hospital cost can be around $30,000.

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Is Non-Adherence to Prescribed Medications Something to Worry About?

2014-06-15T00:01:00.000-04:00

A significant public health problem affecting the health of older Americans is their defying of their prescriptions. This is a significant problem burdening the US healthcare system.

Non-adherence to prescribed medications is a serious health problem in the United States, costing an estimated $100 billion per year, according to Boston Children's Hospital and Harvard Medical School in Boston, MA.

Half on the patients do not take prescribed medications

The Department of Internal Medicine, Rush University Medical Center, in Chicago, IL has found that approximately 50% of patients do not take their medications as prescribed. There are numerous reasons for this health problem. Unique barriers to adherence included understanding new directions, living alone, scheduling medication administration into the daily routine, using potentially inappropriate medications, and uncooperative patients, is what the Department of Pharmacy Practice at Purdue University College of Pharmacy, in West Lafayette, Indiana has found.

Patient Needs to Believe in the Medication

The only solution, at this time, is to include frequent human communication. The Center for Advancing Health has a bit of an addition to that information. The CFAH believes that patient adherence is much more likely to occur when the patient and clinician agree on the basics, e.g., the diagnosis and treatment. If the patient agrees with the diagnosis, the patient believes the medication will work, the patient can afford the medication, and the patient believes the benefits of the medication will outweigh the risks, it is more likely that the patient will continue taking their medication and continue refilling a prescription if it is prescribed.

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What Makes Soap Kill Germs?

2014-06-01T00:01:00.000-04:00

The secret weapon to killing "99.9% of germs is Triclosan, which is a potent synthetic chemical. According to the U.S. Environment Protection Agency (EPA), Triclosan is an antimicrobial active ingredient contained in a variety of products where it acts to slow or stop the growth of bacteria, fungi, and mildew. The Food and Drug Administration (FDA), however, has not received evidence that the triclosan provides an extra benefit to health other than in toothpaste. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

Antibacterial products are unnecessary

The University of Southern California states that it is possible to kill germs without using antibacterial products. With regular soap and warm water, the key is to wash hands long enough. Rather than rinsing immediately after applying soap to hands, rub hands together for at least fifteen seconds before rinsing. According to the above information, soap and water is the best for removing bacteria.

Handwashing with water alone

Handwashing with non-antibacterial soap is much more effective in removing bacteria from hands than handwashing with water only, according to the Department of Infectious and Tropical Diseases at the London School of Hygiene and Tropical Medicine. Although handwashing with water alone reduced the presence of bacteria on hands substantially, the study supports the policy of many current hand hygiene campaigns promoting the use of soap. A Triclosan-based hand cleanser and an alcohol-based hand cleanser are tied at second, at this time, depending on who you get your information from determines which one is actually better.

Pure and True

A bit of extra information. If a drug claim is made on a cleanser or soap, such as antibacterial, antiperspirant, or anti acne, the product is a drug, and the label must list all active ingredients, as is required for all drug products, according to the FDA. Soaps that are labeled "Pure" or "True" are regulated by the Consumer Product Safety Commission, not FDA, and do not require ingredient labeling.

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Is Alcohol-based Hand Cleanser as Good as Soap and Water?

2014-05-15T00:01:00.000-04:00

Everywhere you go, nowadays, you see a bottle of alcohol-based hand cleanser. Whether it be the grocery store, your work cafeteria, the hospital, the library and many other establishments have alcohol-based hand cleanser on the wall for your use.

Alcohol-based hand cleaners outperform soap and water

The results indicate that the alcohol-based hand cleanser dramatically outperforms the traditional hand washing agent in the general dental setting, according to The University of Texas Health Science Center at San Antonio Dental School.

There is another item, we need to be concerned with. Maybe I shouldn't call it an item, but rather call it bacteria. The Mayo Clinic states that clostridium difficile, often called C. difficile or C. diff, is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon.

Soap and water handwashing outperforms alcohol-based cleaners in removing C. difficile

Clostridium difficile was first described as a cause of diarrhea in 1978 and is now among the leading 3 hospital-acquired infections in the United States, states the Division of Gastroenterology and Hepatology at the Mayo Clinic. We love the convenience and ease of using alcohol-based hand cleanser, but according to the Department of Medicine at Sir Mortimer B. Davis-Jewish General Hospital at McGill University in Montreal, Quebec Canada, handwashing with soap and water showed the greatest efficacy in removing C. difficile and should be performed preferentially over the use of alcohol-based handrubs when contact with C. difficile is suspected or likely.

Secret weapon to killing "99.9% of germs is Triclosan, which is a potent synthetic chemical

The Mayo Clinic also states that this is an increasing problem. They warn that each year, more than a half million people get sick from C. difficile, and in recent years, C. difficile infections have become more frequent, severe and difficult to treat.

The University of Southern California, added some important information that needs to be understood. They say that although alcohol-based products are not as effective as Triclosan-based products, the advantage of ethyl alcohol over Triclosan lies in its ability to evaporate completely so that none of the chemical is present for the bacteria to adapt to. Therefore, resistance issues are nonexistent in the use of ethyl alcohol as an antibacterial.

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Are Physicians to Blame for High Healthcare Costs?

2014-05-01T00:01:00.000-04:00

The Division of General Internal Medicine at the Mayo Clinic sent a survey to 3897 randomly selected physicians from the American Medical Association directory, where 65% responded. A breakdown in the numbers shows that most believed that trial lawyers (60%), health insurance companies (59%), hospitals and health systems (56%), pharmaceutical and device manufacturers (56%), and patients (52%) have a "major responsibility" for reducing health care costs, whereas only 36% reported that practicing physicians have "major responsibility.

Physicians are unaware of patients finances

According to the Division of General Internal Medicine at the VA Greater Los Angeles Health Care System, Out of 133 responses from 205 participants, 65% response rate, Physicians reported that they were often unaware of patients' out-of-pocket costs at the time of prescribing. Fifty-nine percent of physicians reported that they never or seldom were aware of patients' "preferred" (lower cost) formulary options when prescribing, and 70% never or seldom were aware of patients' out-of-pocket costs when prescribing.

Is does appear that physicians are willing to accept some of the blame, but they are not willing to accept all of it. A panel of 18 physicians took part in a discussion and agreed that meaningful

While some members would like to see incentives for providers discussing costs with patients, many of the panelists were skeptical that patients could “effectively digest and utilize” information about cost and treatment options. Also, encouraging widespread changes in patient behavior when it comes to prevention and wellness is critical to alleviating costs - See more at: http://medicaleconomics.modernmedicine.com/medical-economics/news/halting-rise-healthcare-costs-physician-panel-presents-five-solutions#sthash.LhWTRh92.dpuf

Meaningful consumer engagement requires better communication and guidance from physicians, more willingness from consumers, and greater investments in prevention - See more at: http://medicaleconomics.modernmedicine.com/medical-economics/news/halting-rise-healthcare-costs-physician-panel-presents-five-solutions#sthash.LhWTRh92.dpuf

consumer engagement requires better communication and guidance from physicians, more willingness from consumers, and greater investments in prevention. as published in Medical Economics.

A panel of 18 physicians took part in an effort by the Robert Wood Johnson Foundation to reach consensus on solutions to help halt the rise of healthcare expenses - See more at: http://medicaleconomics.modernmedicine.com/medical-economics/news/halting-rise-healthcare-costs-physician-panel-presents-five-solutions#sthash.LhWTRh92.dpuf

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Should Dental Stem Cells Be the Fourth Type of Stem Cell?

2014-04-15T00:01:00.000-04:00

There are a couple of unique characteristics that differentiate stem cells from other cells. The National Institute of Health says that there are two characteristics that make stem cells unique. The first is that stem cells are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions.

Studies That Indicate There Are Risks With GMO?

2014-04-01T00:01:00.000-04:00

Every study I have found, done by Monsanto, states that genetically modified food is not a problem. Understandably, none of their studies have found any health issues. For that reason, I am not including any Monsanto studies here. I am focusing on U.S. and foreign governmental and non-profit organizations that have contributed to or performed their own studies on genetically modified foods.

What is genetically modified organisms

Terminology is not always understood by everyone and definitions may be different person-to-person, so the definition of genetically modified organism (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination, according to the European Parliament and the Council of the European Union.

Risks of genetically modified organisms

According to the Department of Environmental Studies at the University of California, there are three reasons for uncertainty in GMO risk analysis:

Body's Past Exposures - A person's health history does not take into account their exposure to environmental toxins and household chemicals.

Dose-Response Relationships - Thresholds and levels of exposure are difficult to accurately assess in terms of health and safety, because the relationship between dosage and response or probability of harm is almost never linear.

Synergistic Effects, and Etiological and Diagnostic Uncertainties - It is extremely difficult, if not impossible, to document conclusively that a specific disease is caused by exposure to specific environmental toxins—an issue referred to in the literature as “etiological uncertainty.”

Food and Agriculture Organization of the United Nations (FAO) has been conducting a worldwide inventory of agricultural biotechnology applications and products, with special reference to developing countries. Preliminary findings indicate that the total area cultivated with GMO crops stands at about 44.2 million hectares, up from 11 million hectares just three years ago. About 75% of this area is in industrialized countries.

The Organization for Economic Co-operation and Development (OECD) uses the term agroecology as the study of the relation of agricultural crops and environment. Agroecologists study a variety of agroecosystems, and the field of agroecology is not associated with any one particular method of farming, whether it be organic, integrated, or conventional; intensive or extensive.
One of the largest-ever studies of commercial rice growing, researchers found that thousands of Chinese farmers using agroecologic techniques saw yield increases of 89% while completely eliminating some of their most common pesticides, according to a national non-profit public interest and environmental advocacy organization, called the Center for Food Safety in California.

No illnesses or injuries reported for genetically modified organisms

The Philadelphia VA Medical Center and American Accreditation HealthCare Commission (URAC), both state that there are no reports of illness or injury due to genetically engineered foods, as noted in U.S. National Library of Medicine. The URAC, formerly known as the Utilization Review Accreditation Commission, is a nonprofit organization promoting healthcare quality by accrediting healthcare organizations an independent, nonprofit organization, is a well-known leader in promoting health care quality through its accreditation, education, and measurement programs.

We should take into account that other countries need and use GMO crops. The European Commission (EC) is responsible for making Europe's citizens healthier, safer, and more confident and it is the European International Program of the Federal Drug Administration (FDA). The Directorate-General Research under the EC has spent €200 million during the past decade on such research, and several member states have initiated national research programmes specifically targeting the potential impact of the very same crops and traits that are in the European approval system, according to the European Commission after a decade of EU-funded GMO research from 2001–2010.

There was no evidence of cry1Ab gene or Bt toxin translocation to organs or blood following long-term feeding, according to the Pig Development Department, Animal and Grassland Research and Innovation Centre in Ireland.

All genetically modified organizms are considered safe

The Federal Institute for Risk Assessment or the Bundesinstitut für Risikobewertung in Germany states that All genetically modified plants and derived food products, which have been evaluated by Europian Food Safety Authority (EFSA) so far, were considered to be as safe as products derived from the respective conventional plants. The EFSA is an independent European agency funded by the EU budget that operates separately from the European Commission, European Parliament and EU Member States.

A study done, in France, by the Committee for Independent Information and Research on Genetic Engineering (CRIIGEN), found that male rats lost 3.3% in weight and the female rats gained 3.7% in weight after consuming MON 863, and they stated that longer experiments are essential in order to indicate the real nature and extent of the possible pathology; with the present data it cannot be concluded that GM corn MON863 is a safe product. The Institute for Responsible Technology, however, is adamant that the MON 863 study should have been rejected because nutritional data and methodology is missing, as well as, inappropriate and missing controls. This MON863 study is documented on the National Center for Biotechnology. There are numerous other studies explained on the "Institute for Responsible Technology" website noting the hazards of GMO, but I was not able to find any information of those studies in the National Center for Biotechnology Information.

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What Makes Mouthwash Long Lasting?

2014-03-15T00:01:00.000-04:00

There are numerous varieties mouthwash. In this case only Scope has been chosen to compare, rather than any other well known or little known brand. The names for the varieties of mouthwash are intriguing.

Below are the material safety data sheets (msds) for a few varieties of Scope mouthwash.

Scope Original

Scope Long Lasting

Scope Concentrate Peppermint

Is it a Drug or cosmetic product

In order to determine the differences, the data sheets were compared. The first notable difference is that the Original flavor is a drug product under the Food and Drug Administration (FDA) and the Long Lasting is a cosmetic product under the FDA. The concentrate is different. It was issued in 2007 and is probably grandfathered in as a mixture and was determined before the term cosmetic was defined. Whether a product is a cosmetic or a drug under the law is determined by a product's intended use.

Another difference between a drug and a cosmetic is, under the FD and C Act, which became legislated in 1938, is that cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA.

What is a Cosmetic product

According to the FDA, the term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

What is a Drug product

Drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals, as stated by the FDA.

Scope Original, Long Lasting, and Concentrate differences

A difference in the Scope mouthwashes is with the Original flavor, medical attention should be seeked if ≥2.0 ml/kg is ingested and medical attention should be seeked if ≥3.0 ml/kg is ingested with the Long Lasting and ≥0.5 ml/kg with the Concentrate.

The Concentrate has 30-60% alcohol and 10-30% glycerine, where the other two have 10-30% alcohol and 5-10% glycerine.

The flash point is the temperature at which a particular organic compound gives off sufficient vapor to ignite in air. On the Original variety, the flash point is 102 degrees Fahrenheit, where the flash point on the Long Lasting is 110 degrees Fahrenheit and the Concentrate is 72 degrees.

The pH is 5.5 on the Long Lasting, where the ph on the Original and the Concentrated is not available. Boiling point of the Original and Concentrated is ~190 degrees Fahrenheit and the boiling point of the Long Lasting is not available.

The last difference I could find is the benzoic acid concentrate on the Long Lasting is less than 1%, where it is not noted on the Original and that is below reporting threshold, so the Original could very well have a tiny bit of benzoic acid, but departments report differently. Drugs.com defines Benzoic acid as naturally occurring in gum benzoin, it is used as a food preservative, locally as a fungistatic, and orally as an antiseptic. So, it is used to help prevent infection caused by bacteria, which indicates to me that the main difference between the composition of the mouthwashes is the Long Lasting has benzoic acid.

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Is Chewing Gum Good for Your Teeth?

2014-03-01T00:01:00.000-05:00

So, you're away for the weekend and you forgot your toothbrush and toothpaste. Chewing sugar-free chewing gum promotes a strong flow of stimulated saliva, which helps to provide a number of dental benefits: first, the higher flow rate promotes more rapid oral clearance of sugars, says Wrigley Jr Company in their studies.

Stick or pellet gum reduces debris on teeth

Yes, of course, this company markets sugar free gum. However, at the Department of Preventive Dentistry, Sichuan University in China, a study was also done comparing chewing gum and non-chewing gum and the resulting debris on teeth. The University found that Chewing either stick gum or pellet gum resulted in significantly lower oral debris scores (P < 0.0001) compared to the control (no-gum) treatment for all intraoral sites, while no significant difference was observed between the two chewing gum groups.

Stick or pellet gum reduces stain on teeth

Other studies have been done with chewing gum and stain on teeth. At the University of Siena Dental School in Siena, Italy supported a trial that showed a reduction in dental stain by a chewing gum containing sodium tripolyphosphate after six weeks. We all know that nicotine gum has been used to reduce smoking.

Stick or pellet gum reduces supragingival calculus on teeth

Also, in the Dental School at the University of Florence, Florence, Italy These results indicated that chewing gum containing pyrophosphate and tripolyphosphate reduced supragingival calculus formation by 13.9%, compared to the placebo chewing gum.

Chewing gum after eating can prevent tooth decay

The ADA (American Dental Society) also publish on their website that Clinical studies have shown that chewing sugarless gum for 20 minutes following meals can help prevent tooth decay. It wouldn't surprise me if you already had this figured out and have purchased gum with some kind of mint flavoring to make your mouth feel cleaner.

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Chew gum to keep mouth healthy, lose weight, focus.(Report): An article from: Environmental Nutrition

Is Dental Health a Problem for Those with Parkinson's Disease?

2014-02-15T00:01:00.000-05:00

Parkinson's Disease results in dysfunction of behavior and slowness of movement and these symptoms negatively influence the patient's capability to carry out the daily oral hygiene tasks. According to a service of the U.S. National Library of Medicine, Parkinson's disease (PD) is a type of movement disorder that happens when nerve cells in the brain don't produce enough of a brain chemical called dopamine and most often develops after age 50.

Parkinson's Disease challenges in oral care

The Department of Human Pathology and the Odontostomatology Department at the University of Messina and theDepartment of Mechanical Engineering, Facilities, and Infrastructure at the Guglielmo Marconi University, both in Italy, performed studies that point out that during oral care, frequencies of missed teeth and periodontal disease were significantly higher in the Parkinson's Disease patients group. The Parkinson's Disease Foundation (PDF) confirms this saying that Parkinson’s often poses unique challenges in establishing and maintaining an effective dental treatment strategy.

Parkinson's Disease dry mouth syndrome

A symptom of Parkinson's Disease may be increased cause coughing or choking which can be fatal. Since alcohol dries out the mouth, makes you more thirsty, thus encouraging liquids, for someone with Parkinson's Disease this coughing deems unnecessary. Keeping this in mind, the Foundation states that mouthwashes are generally discouraged for people with Parkinsn's Disease because they present the risk of choking, but in cases where they are still an option, it is best to look for those that are non-alcohol based and that use either chlorhexidine (an antiseptic) or baking soda.

For the Parkinson's Reversing Breakthrough Click Here!

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