Basically, dry mouth is a painful condition that results when the salivary glands do not function properly. While saliva is an important agent that helps in the swallowing of food, it is also a natural defense against tooth decay. Saliva plays a major role in rinsing away food particles and in neutralizing harmful acids that might attack the teeth. It helps prevent gum disease and infections of the mouth tissues. A person may have difficulty in speaking, and their sense of taste can be hindered when a lack of saliva exists.

A dry mouth condition can develop from a number of sources. Radiation administered to the head and neck region is one known cause. However, with increased uses of medications such as antidepressants, diuret­ics, antihistamines and even decongestants in society today, increasing numbers of dry mouth cases are being reported.

The results of two separate studies indicate that Acupuncture can offer help to people who suffer from this condition. Prior to trying Acupuncture, most sufferers relied on more short-term substitutes and gland stimu­lants like sucking on lozenges or chewing gum, for example.

One study reported in General Dentistry, the journal of the Academy of General Dentistry, indicated posi­tively that Acupuncture provided help for 7 radiation therapy patients with dry mouth. Each of the patients was seen once a week for 4 or 5 weeks and biweekly for several more sessions. Follow-ups done on these pa­tients up to 8 months later found reduction in dry mouth symptoms, increased saliva flow and having an im­proved ability to eat and speak.

In a separate study, this one conducted on cancer patients in Sweden and reported in the journal Oral Dis­eases, 70 cancer patients with dry mouth conditions were treated with Acupuncture. Their treatment involved 24 individual Acupuncture sessions given twice a week over a four-month period. The results of this study were very encouraging as well with researchers pointing to “significantly higher saliva flow rates” for each of their groupings of patients following Acupuncture.

Hopefully, this is not a condition that will develop for you or a member of your family or circle of friends. However, with radiation being increasingly used for cancer treatments and greater amounts of antidepressant drugs being administered in society, the possibility does exist that someone you come into contact with will complain of this condition. Wouldn’t it be nice if a suggestion to that person to try Acupuncture helped to bring relief?

Source: Acupuncture.com. “New Report Indicates Acupuncture Provides Relief for Suffers of Dry Mouth.” June 2005. http://acupuncture.com/news/drymouth.htm and Acupuncture Today. “Acupuncture for Dry Mouth.” http://www.acupuncturetoday.com/mpacms/at/article.php?id=27653

Sales of Lipitor account for over $12 billion in annual revenues worldwide. It is widely prescribed by doc­tors for both men and women as a way to lower cholesterol levels in the body. People who take it believe they are able to reduce their risk of heart attack and stroke. Pharmacuetical giant, Pfizer Inc., markets Lipitor as being beneficial for those adults with a risk of cardiovascular disease.

Researchers at Cornell University recently assembled and evaluated all of the scientific data and test results available on Lipitor. It may come as a surprise to a lot of people that they were able to find no statistically sig­nificant supporting scientific evidence to show that women who take Lipitor were getting any protection from cardiovascular problems. The results of the study were published in the September issue of the university’s Jour­nal of Empirical Legal Studies.

“Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks, but that scientific evidence supporting their hope does not exist,” the study’s authors said.

Pfizer widely advertises Lipitor as a means to reduce the probability of heart attack for people who have a mixture of risk factors for heart attack, such as age, high blood pressure, low HDL levels (high-density lipopro­tein, the good cholesterol), family history or smoking. It appears from the research that study findings of bene­fits for the male population have simply been extrapolated to include women as well. Of course, Pfizer makes no mention of this in its advertising or product labeling regarding use by women.

It is most interesting to note that none of the studies that included women with a mixture of risk factors provided any statistically significant support for prescribing Lipitor or other statins to protect against cardiovas­cular disease, researchers said. Pfizer’s claims of clinical proof that Lipitor reduces the risk of heart disease in women appear to be unfounded and aimed more at marketing billions of dollars worth of the product than pro­viding any real help.

This research gives credence to looking at methods beyond drugs to achieve cholesterol reduction and overall heart health. A combination of a healthy diet with reduced intake of meats and dairy products, in con­junction with exercise, has been shown to improve cholesterol levels. A wellness consultation with a natural healthcare professional would be a good place to start to arrive at a diet and exercise program which promotes healthy living for both women and men.

Source: Science Daily. “Top-selling Cholesterol Drug Does Little for Women, Study Suggests.”
September 2008. http://www.sciencedaily.com/releases/2008/09/080917145147.htm

Recently, 105 children were tested for three different cough solutions. They were divided into three test groups and the study extended over two nights. On the first night, the children received no treatment and their parents were asked five questions about their child’s condition. On the second night, the first group received a single dose of buckwheat honey. The second group got honey-flavored dextromethorphan (this is a common ingredient in over-the-counter medications) and the third group got nothing at all. The treatment doses were administered 30 minutes before bedtime. The parents were then asked the same five questions about the child’s condition.

Study results showed the honey group consistently reported the highest frequency of relief according to the parents surveyed. A lesser amount of relief was provided by the honey-flavored drug group, and with those getting nothing at all recording the worst scores.

The study was conducted at the Penn State College of Medicine under the direction of Ian Paul, M.D. The results were published in the Archives of Pediatrics and Adolescent Medicine. In a previous study in 2004, Dr. Paul showed that neither dextromethorphan nor diphenhydramine, another component of cough medications, performed better than a placebo to reduce coughing or improve sleep. Since then, the U.S. Food and Drug Administration has recommended that over-the-counter cough and cold medications not be given to children under six due to a lack of effectiveness and their potential for creating drug related side effects.

Honey, on the other hand, has been used for centuries to help a variety of health problems. It has known antioxidant and antimicrobial qualities. It is also known to contribute to wound heal­ing. According to researchers, the only possible negative side effect of the honey treatment, as reported by parents, was mildly heightened hyperactivity in some cases. One additional word of warning is that honey should not be administered to children less than 2 years old as it can con­tain-botulism causing endospores that may be a problem for young children.

That said, honey may be an excellent replacement for drugs and a time and money saver for children and parents alike. According to the study information, approximately three percent of all outpatient doctor visits in the United States are cough related. Consumers spend billions of dol­lars each year on over-the-counter cold medications, many of which prove to be very ineffective. And, with honey as the treatment that helps children, lots of parents may get a much better night of restful sleep with fewer coughs coming from their child’s bed.

Source: Penn State College of Medicine. Press Release. “Honey a Better Option for Childhood Cough than Over-the-Counters.” December 2007. http://dcscience.net/honey–press-releases.pdf

CDC received the first reports of a potential problem with heparin from the Missouri Department of Health and Senior Services on Jan. 7, 2008. The reported symptoms that occurred within minutes of starting dialysis included facial swelling, excessively rapid heart beat, a drop in blood pressure, skin rash and nausea. A total of 8 episodes occurred at a pedi­atric hospital in the state from Nov. 19, 2007 to Jan. 17, 2008.

Upon learning of this initial cluster, CDC solicited reports of similar allergic-type reac­tions among hemodialysis patients nationally. On Jan. 9, 2008, CDC was contacted by a dial­ysis supply company that had received reports during the previous 2-week period of some 50 similar reactions among adult hemodialysis patients at dialysis facilities in 6 states. A second supply company reported learning of similar reactions from dialysis facilities as early as Dec. 10.

Of the episodes reported as of Jan. 30, CDC has identified 65 confirmed or probable cases among 53 hemodialysis patients that occurred from Nov. 19, 2007 to Jan. 21, 2008, at 19 dialysis facilities in 12 states. CDC currently is investigating an additional 36 possible cases. Other than the 8 episodes reported in Missouri, all cases have occurred among adults.

After learning of these adverse events among patients who received heparin during dialy­sis, Baxter voluntarily recalled nine lots of heparin multi-dose vials on Jan. 17, 2008. All nine lots were produced at a single plant; eight of the nine lots were produced during September to November 2007. Despite the Jan. 17th recall, an additional reaction occurred on Jan. 21, 2008, after a hemodialysis patient was administered Baxter heparin from one of the recalled lots. CDC has found indications of delays in removing the recalled lots of heparin from distri­bution, which might result in continued exposures.

In addition, these reactions might not be limited to hemodialysis settings. One cardiac-care facility has reported 7 allergic-type reactions among cardiac patients who received heparin from lots that were later recalled. CDC alerted the U. S. Food and Drug Administration (FDA) to these nationwide reports of allergic-type reactions on Jan. 9, 2008, and is collaborating with FDA on the investigation.

* Def. Dialysis: (Med.) Purification of the blood in substitute of the kidneys.

Source: The U.S. Centers for Disease Control and Prevention, “Acute Allergic-type Reactions Among Patients Undergoing Hemodialysis, Multiple States, 2007-
2008.” January 2008. http://www.cdc.gov/mmwR/preview/mmwrhtml/mm57e201al.htm

Dr. Joseph Biederman of the Harvard Psychiatry Department has been known to be very involved in research with powerful antipsychotic medicines. According to Senator Grassley’s report, Dr. Biederman has taken and failed to properly report at least $1.6 million in drug com­pany income. The payments were received between the years 2000 and 2007. During this time, the doctor failed to follow the proper reporting procedures as set out by the university regarding payments from drug companies.

Dr. Timothy E. Wilens of the Harvard Medical School is a second person cited by Senator Grassley as circumventing the reporting system. His unreported income is also in the area of $1.6 million. A third colleague of the two doctors, Dr. Thomas Spencer, has unreported income of over $1 million.

In beginning the investigation, Senator Grassley said he had asked to see the report forms the doctors had presented to the University regarding drug company payments. He said the forms were a mess and his staff had a hard time even reading them. That’s when he asked the University to have a second look at the monies received from drug companies, and this is when things got interesting, he said. This is when Drs. Biederman and Wilens belatedly disclosed their $1.6 mil­lion each, and Dr. Spencer admitted to over $1 million.

Speaking to the Congressional Record, Sen. Grassley said, “What makes all of this even more interesting is that Drs. Biederman and Wilens were awarded grants from the National Institutes of Health to study the drug Strattera^®. Obviously, if a researcher is taking money from a drug company while also receiving Federal dollars to research that company’s product, then there is a conflict of interest. That is why I am asking the National Institutes of Health to take a closer look at the grants they give to researchers.”

Senators Grassley and Herb Kohl of Wisconsin are co-sponsors of the Physician Payments Sunshine Act, a bill introduced into Congress in September 2007. The aim of the bill is to pro­vide for transparency in relationships between physicians and drug manufacturers for which pay­ments are made under government programs. It is aimed at doctors and drug companies making honest disclosures and discovering when conflicts of interest exist. The bill is currently being con­sidered by the Senate Finance Committee.

In the meantime, Sen. Grassley’s investigators continue to look into matters such as this one at Harvard. Likely what they are discovering is only the tip of the iceberg in terms of payments made, received and hidden from view.

Source: GovTrack.US. “Payments to Physicians. The United States Senate.” June 2008. http://www.govtrack.us/congress/record.xpd?id=110-s20080604-268zperson=300048

According to the most recently available numbers provided the Agency for Healthcare Research and Quality, the number of women who now have the C-section procedure is nearing 1/3 of all births. About 1.3 million women in 2005 gave birth through a C-section. This figure represents a 38 percent increase over 1995. That year, about 800,000 C-sections were performed in the U.S.

C-sections have their rightful place in deliveries when complications would be thought to put either the mother or the child at risk. An umbilical cord wrapped around the child’s neck or a breech delivery would be two common reasons for a C-section delivery.

More recently, C-sections are being performed for many other reasons including convenience, a feeling by attending physicians that the procedure reduces lawsuit risk and even the idea that this type of delivery is better for the mom and child than a normal vaginal delivery.

The area of sharpest decline in vaginal deliveries occurred in the case of those mothers who had previously given birth via C-section. Vaginal deliveries of subsequent children dropped 60 percent from 157,200 in 1995 to just 63,300 in 2005. Apparently some doctors and hospitals are not allowing a woman to consider and attempt vaginal delivery following a C-section delivery.

Another major contributing factor to the increase in C-sections would logically be financial. In 2005, hospitals charged a total of $17.4 billion for about 1/3 of the deliveries through C-sec­tion. Hospitals took in just $21.3 billion for the remaining 2/3 of the deliveries. Clearing, the profit lies in C-section deliveries!

Consider the difference in costs based on 2003 figures as provided by the U.S. Agency for Healthcare Research and Quality.

• Vaginal birth with no complications: $6,239.
• Vaginal birth with complications: $8,177.
• C-section with no complications: $11,524.
• C-section with complications: $15,519.

At about $5,000 more for an uncomplicated C-section and over $7,000 more for a complicat­ed procedure above vaginal delivery, is it really any wonder that the medical profession, as well as hospitals, might like to see the number of C-sections rise even higher in the years to come?

Source: The World Chiropractic Alliance. “Number of C-sections Soar: Hospitals Made $17.4 Billion on Procedures.” June 2008. http://www.worldchiropracticalliance.org/tcY2008/jun/j.htm

This brings up the question, “Is it possible for the average patient to reduce the risk of experi­encing a medical or prescription error? According to the New York State Health Department the answer is yes, and the organization has provided a lengthy list of advices to “help prevent medical errors.”

Number one in importance is this: “The single most important way you can help to prevent errors is to be an active member of your healthcare team.” This means that a person should actively take part in each and every decision because research shows that patients who are more involved in their care tend to get better results.

Imagine trusting your doctor to do surgery on your left knee only to find out upon awaken­ing that the procedure was done on your right leg? According to the advisory, wrong-site surgery is something that should be 100% preventable and patient involvement with a doctor prior to sur­gery can go a long way to preventing it. “The American Academy of Orthopedic Surgeons urges its members to sign their initials directly on the site to be operated on before surgery,” says the advisory. Get involved and get it right would be the advice.

Regarding hospital stays, it’s best to select a hospital where many patients have already received the procedure you need. Infections received in a hospital are sometimes more dangerous than the procedure, so make certain everyone in the hospital who has any contact with you wash­es their hands. When leaving the hospital, get specific instructions for your continued recovery.

Medication errors are way too frequent. Here are some simple things to do to help prevent them. It starts with fully informing a doctor if you are taking any medications, have any allergies or any prior adverse drug reactions. Make sure that you can read the prescription written by the doctor and get it rewritten if you can’t. When getting the prescription filled, make sure you ask the pharmacist if the one you’re getting is what was prescribed. Don’t be afraid to ask the phar­macist lots of questions about taking the medication.

Finally, learn to speak up when you have questions, and make the doctor answer no matter how busy he seems or how quickly he wants to get you out of the office so he can get on to the next patient. Take a family member or advocate with you if you need help doing this. Also, learn everything you can about your condition and treatment. There is a wealth of information avail­able these days over the internet, for instance. The more you know the more you can have a say in your own correct treatment. This will go a long way to providing you with a good chance for a healthy recovery and avoiding becoming a medical statistic.

Source: The New York State Department of Health. “20 Tips to Help Prevent Medical Errors.” http://www.health.state.ny.us/nysdoh/healthinfo/20tips.htm

Two years ago, Public Citizen sued the FDA to withdraw the painkillers Darvon^® and Darvocet^® from the market and the FDA has not acted on this petition. According to the lawsuit filed in U.S. District Court for the District of Columbia, the FDA is putting the public at risk by allowing these drugs to remain on the market.

Darvon and Darvocet both contain propoxyphene, a drug that is known to be both physically and psychologically addictive. The suit claims that the drug is no more effective than safer alternatives on the market and has been associated with more than 2,000 deaths in the U.S. since its launch in 1981. Despite health risks associated with the drug, it was the 25th most prescribed generic drug on the market last year with more than 22 million prescriptions filled in American pharmacies in 2007.

The Public Citizen petition of 2006 was seeking the gradual withdrawal of all products containing propoxyphene from the U.S. market as has now been required in the United Kingdom. The phased withdrawal of Darvocet from the British market began in 2005 following the recommendation of the U.K. Committee on Safety of Medicines (CSM). A CSM report concluded at the time that it could not “identify any patient group in whom the risk-benefit ratio may be positive” for Darvocet. The complete withdrawal of this drug from the market was achieved by the end of 2007.

Three years after the British government began to withdraw Darvocet and two years after Public Citizen petitioned to initiate phase out here, the FDA has done nothing to protect Americans from the dangerous side effects of propoxyphene, the suit alleges. The main reason for this request is that the drug is considered to be highly toxic to the heart and can lead to interruption of heart transmis­sion of electrical impulses, slowed heartbeat and a decreased ability of the heart to contract properly. Depression is another side effect of the drug.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen said, “Top FDA drug officials, including Center for Drug Evaluation and Research Director Dr. Janet Woodcock and Dr. Robert Temple, are well aware that this drug has considerable human toxicity, addiction potential and abuse liability, but very limited therapeutic usefulness. Given this extremely unfavorable ratio of risks to benefits, it is inexcusable that the FDA did not take propoxyphene off the market long ago. It is our hope that his lawsuit will force the agency to finally begin this desperately needed regulatory process.”

Public Citizen is a national, nonprofit consumer advocacy group founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

Source: Public Citizen. Press Release. “Public Citizen Sues FDA for Failure to Act on Dangerous Drug.” June 2008
http://www.citizen.org/pressroorn/release.cfm?1D=2677

The state brought suit against Lilly to recover the many millions of dollars spent in treating patients who had experienced weight gain, high blood pressure and dia­betes as a result of taking Zyprexa. The lawsuit was a result of the state’s claim that it and healthcare providers received insufficient warning that the use of Zyprexa may result in one or more of these medical conditions.

The lawsuit asked that Lilly pay the state for those costs and also pay for civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act.

Before the trial got underway, Judge Mark Rindner ordered ongoing mediation to occur between the two parties. The $15 million dollar settlement agreement is far less than state Attorney General Talis J. Colberg was seeking at the trial’s outset, but he was satisfied with the end result.

“I am very pleased with the efforts by Assistant Attorney General Ed Sniffen and our team of trial attorneys, Colberg said. “We believe this is a good result for the State of Alaska and the Department of Health and Social Services.”

In agreeing to the settlement, Eli Lilly and Company did not admit to any wrongdoing in their promotion or sale of Zyprexa in Alaska. Lilly’s senior vice president and general counsel said, “While we had a strong defense, we agreed with the state that the best result for everyone is an amicable resolution.”

Included in the settlement for the state is the assurance that Alaska will be treat­ed as favorably as any other state that may settle with Lilly over similar claims.

Zyprexa was first approved as an “atypical antipsychotic” to treat schizophrenia and bipolar disorders. Since then, it has been prescribed to over 23 million people in the United States and 80 other countries.

Currently, nine other states have lawsuits pending against Lilly that are very sim­ilar to this one in Alaska. Also, 33 additional states are in the process of investigat­ing a joint action against the company seeking a claim settlement.

Source: Inside Indiana Business. Press Release, March 2008. http://www.insideindianabusiness.corn/newsitem.asp?1D=28529

VIOXX^® is a drug that Merck promoted as a pain reliever. It came on the market in 1999. At that time, a very aggressive television advertising campaign was launched and this triggered a demand for prescriptions before the full effects of the drug were known. When later research proved that VIOXX^® users had more than double the risk of heart attack and stroke, it was pulled from the market in 2004 amid a rash of lawsuits.

A total of 30 states and the District of Columbia have been involved in the 3-year investiga­tion into Merck’s practices. Allegations were then presented that Merck was deceptive in playing down the health risks of the drug, especially having to do with two deaths that occurred during the drug’s trial period and the fact that it didn’t work in treating or preventing the onset of Alzheimer’s disease.

It was also discovered that Merck had paid ghostwriters to provide scientific articles about VIOXX^®. The work of these company-paid writers was then published under the names of aca­demic scientists who had been paid to take credit for the articles!

Arkansas is one of the states that will share in the settlement to the tune of $1,283,974.90. Perhaps a more meaningful result, in addition to the settlement to the 30 states, is that Merck’s advertising is now going to come under greater scrutiny from the U.S Food and Drug Administration. “Today’s judgment requires Merck to submit all “direct-to-consumer” television drug advertisements to the FDA, wait for approval and comply with FDA comments before run­ning the advertisement,” said Arkansas Attorney General Dustin McDaniel. In other words, the FDA will now have the authority to assess all Merck direct-to-consumer advertising for any new drugs the company plans to release. They will also be required to submit all television ads to the FDA for possible revision and acceptance before they are run on television.

The attorney generals of the prosecuting states had expressed concerns regarding the negative effect drug advertising can have on the population when it begins immediately with the introduc­tion of the new drug. One of the results is that doctors don’t have any opportunity to assess the drug and gain any experience with possible side effects before many of their patients are coming in to ask them about it and requesting a prescription.

In anticipating the settlement, Merck took a $55 million first quarter pre-tax charge to offset the $58 million they are now required to pay to the states.

Source: The State of Arkansas Attorney General’s Office. “McDaniel Announces Merck Settlement Resolving a 3-year Investigation into the Company’s Marketing of VIOXX^®. May 2008. http://ag.arkansas.gov/newsroom/index.php?do:newsDetail=18znews_id=174 and Merck Co. Inc. “Merck Resolves Investigations under State Consumer Protection Statutes Related to VIOXX^®:’ May 2008. http://www.merck.com/newsroom/press_releases/corporate/2008_0520.html

Here is a case report of one person who experienced relief from an RLS treatment. Her name is Sylvette Hickey, and she works in the medical profession as a Registered Nurse. This report is about her success with Acupuncture.

Her account begins by stating that she’d been having on-going problems with RLS for several years. Uncomfortable feelings in her legs at night were the first symptoms she noticed. She said that the condition became so painful that it was impeding her sleep.

“I remember trying to sleep with my legs propped up along the wall. Sleeping in a sit­ting position was another of my ‘poses.’ When neither worked, I would pound on my legs with my fists to try to alleviate the discomfort,” she reported. Over-the-counter medica­tions like Advil^® and Tylenol^® were also used frequently.

It was at this point, looking for solutions, that she turned to Acupuncture.

Actually, Ms. Hickey was already receiving some Acupuncture to help her with back pain. She was very satisfied with how these treatments had been significantly helping her back.

“I asked Steve (my acupuncturist) if treatments could help my condition (RLS), and he suggested I try a few sessions. Imagine my utter shock when after the first treatment I slept like a baby,” she said.

Her success with sleep continued following her treatments. For one year after she said that her RLS remained under control. Now, she gets an occasional treatment if it ever flares up again. In the meantime, she has also continued to educate herself about RLS and the effects of the disorder.

“Anyone who suffers from RLS should see an acupuncturist…give it a try,” she says.

Source: Acupuncture.com. Case History. www.acupuncture.com/testimonials/r1s.htm

Exubera is a drug made by the pharmaceutical company Pfizer, Inc. When it came on the market approximately two years ago, it was approved by the U.S. Food and Drug Administration and hailed as the first new delivery system in some 80 years: “Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,” said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA, in January 2006 when Exubera was approved. It is our hope that the availability of inhaled insulin will offer patients more options to bet­ter control their blood sugar.”

Now, however, in light of six cases of diagnosed lung malignancies among participants in the clini­cal trials, the FDA has issued a safety alert on the product. Pfizer, in turn, has sent appropriate letters of warning to healthcare providers and to persons known to be using the product. In addition to the six malignancies reported on test victims, one more case of cancer has been reported by a user follow­ing the release of Exubera.

The drug had been approved to treat the two major types of diabetes – Type 1 and Type 2. Persons with Type 1 produce virtually no insulin, and Type 2 victims do not produce enough insulin to control their blood sugar levels. Exubera is delivered in a powdered form using a special type of inhaler.

Some 2,500 persons were involved in the clinical testing of Exubera. While seven cases of cancer have developed and a warning about the product issued, the FDA backpedaled on banning the drug. There are too few cases of cancer to determine whether the emergence of these events is related to Exubera, the warning letter said. It also pointed out that all of the cancer victims had been smokers earlier in their life.

On the other hand, the FDA considers it wise for healthcare providers to prescribe a different product than Exubera. “Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients’ glycemic control. (Glycemic control refers to maintaining proper blood sugar levels following ingestion of carbohydrates.)

As previously stated, safety alert letters have been sent by Pfizer, Inc. to healthcare providers and to users. While these letters maintain that Exubera remains a safe and approved treatment, healthcare providers and Exubera users would be wise to follow the FDA warning and “seek alternative options.”

Source: The U.S. Food and Drug Administration. 2008 Safety Alerts. “Exubera Inhalation Powder?’ April 2008
http://www.fda.gov/medwAtch/safety/2008/safety08.htm#exubera and “FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes.” January 2006. http://www.fda.gov/bbs/topics/news/2006/NEW01304.html

A variety of drugs that doctors prescribe for these problems fall into a class known as anti­cholinergic medications. These drugs work to block the neurotransmitter acetylcholine. This sub­stance affects the way nerve impulses are transmitted, thus producing such effects as reduced blood pressure or lesser symptoms of depression. Some are used to control allergies or stomach acid and others to reduce incontinence.

A recent study found that these medications are producing undesirable effects on older per­sons. One of the very noticeable changes is that older people taking these medications are walk­ing more slowly. In essence, many are behaving in a way that would be characteristic of a person who is several years older than their current chronological age.

“These results were true even in older adults who have normal memory and thinking abili­ties,” said Kaycee M. Sink, M.D., lead author of the study recently completed at the Wake Forest University School of Medicine. “For older adults taking a moderately anticholinergic medication, or two or more mildly anticholinergic medications, their function was similar to that of someone three to four years older.”

Generally, blood pressure medications have a mild level of anticholinergic properties. Antacids would have a higher amount, and incontinence medications would be very high in the blocker. In the study of more than 3,000 persons with an average age of 78 years, 40 percent of the partici­pants were taking more than one anticholinergic drug.

In another study, researchers found that patients who received dementia drugs and medica­tion for incontinence at the same time had a 50 percent faster decline in their functions than did persons who were being treated only for dementia. “Over a year’s time, the decline we observed would represent a resident going from requiring only limited assistance in an activity to being completely dependent, or from requiring only supervision to requiring extensive assistance in an activity,” said Dr. Sink.

The two most common medical conditions in nursing homes for which drugs are given have to do with dementia and urinary incontinence. Caregivers who are responsible for aging parents or loved ones in a nursing home would be wise to check with the person’s physician regarding prescriptions for these two conditions. If anticholinergic medications and dementia medicines are both being prescribed, there is a very good chance that the aging process of the patient will be rapidly accelerated, according to the results of this study.

Source: Wake Forest University School of Medicine. Press Release. “Dual Treatment of Incontinence and Dementia Associated with Functional Decline” May 2008. http://wwwl.wfubmc.edu/News/NewsARticle.htm?ArticlelD=2359 and Science Daily. Press Release. “Commonly Used Medications Associated with Impaired Physical Function in Older Adults?’ May 2008. ttp://www.sciencedaily.com:80/releases/2008/05/080504095641.htm

The latest survey to reach this conclusion was conducted at Harvard Medical School. Charles S. Day, M.D. and colleagues did their work in analyzing 449 medical students during the 2005-2006 academic year. The researchers hoped to determine the level of importance students placed on musculoskeletal education in terms of their future careers, as well as their current level of confidence in performing musculoskeletal exams. A competency exam to assess a student’s cognitive understanding of musculoskeletal medicine was also adminis­tered.

It is interesting to note that medical students rated musculoskeletal education to be of major importance. On the other hand, they gave an overall poor rating to the amount of cur­riculum time spent on the subject. Overall, the students did not feel adequately trained or informed to either examine the musculoskeletal system or to generate a differential diagnosis.

Exam scores were equally telling. The average score of all 2nd through 4th year medical students fell below the passing mark of 70 percent. Only percent of 3rd year students passed the exam, but 4th year students improved this mark to 26 percent passing. One ray of hope was that those 3rd and 4th year students who took musculoskeletal elective classes did signif­icantly better than those who only attended the required classes.

A test to determine if fundamental knowledge of the musculoskeletal system carries over with doctors once they leave medical school and go into practice was recently administered through a University of Washington study. Here the scores of 92 physicians who took a test of musculoskeletal knowledge were examined. Results showed that more than half (59) of the participating doctors scored less than 70 percent. However, those doctors who took elective courses in this area scored higher than those who only took the required course load.

Both of these studies concluded that greater emphasis is needed on training in muscu­loskeletal conditions for students during their four years of medical school. Fortunately, Chiropractors are very well trained and extremely well versed in the diagnosis and treatment of musculoskeletal conditions. Part of a medical doctor’s schooling should include a full understanding of a Chiropractor’s professional abilities so as to be able to quickly refer patients to the right doctor to bring about a speedy recovery.

Source: The Chiro Web. “MDs, Med Students Still Deficient in Musculoskeletal Knowledge,” February 2008. http://www.chiroweb.com/archives/26/04/11.html

“Drug reps increase drug sales by influencing physicians, and they do so with finely titrated (measure and adjust dosage) doses of friendship,” according to Adriane Fugh-Berman of Georgetown University Medical Center and Shahram Ahari, a former drug rep for Eli Lilly who now works for the School of Pharmacy at the University of California San Francisco.

Drug reps are selected for their presentability and outgoing natures and are trained to be obser­vant, personable and helpful. They are also trained to assess physician’s personalities, practice style and preferences and to relay this information back to the company. Personal information may be more important than prescribing preferences. “Good details are dynamic and the best reps tailor their messages constantly to their client’s reaction,” say Fugh-Berman and Ahari.

“A friendly physician makes the rep’s job easy because the rep can use the ‘friendship’ to request favors in the form of prescriptions. Physicians who view the relationship as a straightfor­ward goods-for-prescriptions exchange are dealt with in a businesslike manner. Skeptical doctors who favor evidence over charm are approached respectfully, supplied with reprints from the med­ical literature and wooed as teachers. Physicians who refuse to see reps are detailed by proxy. Their staff is dined and flattered in hopes that they will act as emissaries for a rep’s message.”

Pharmaceutical companies carefully monitor this investment of time and energy in doctors through prescription tracking. The major pharmacies sell their records of prescriptions written by doctors and this information is then linked to individual doctors via a physician identification number provided through agreements with the American Medical Association. In 2005 alone, it is estimated that the AMA coffers benefited to the tune of $44 million providing this information on their members to drug companies.

Physicians are ranked on a scale of one to ten based on how many prescriptions they write with “high-prescribers” lavished with attention, gifts and unrestricted “educational grants.” The fact that physicians are often overworked, under-appreciated and overwhelmed with paperwork makes them susceptible to the charm, warmth and sympathy of a friendly and cheerful drug rep accord­ing to Fugh-Berman and Ahari.

It’s all about getting physicians to use the product and samples that plays a large role in this game. “Reps provide samples only of the most promoted and usually most expensive drugs. Patients given a sample for part of a course of treatment almost always receive a prescription for the same drug.” When this occurs, the drug rep has done their job by increasing drug sales of the product they are pushing. And it all happens through a person carefully chosen and trained to fol­low the company script with the foremost goal to influence the prescription-writing habits of physicians.

Source: The Public Library of Science 2007. http://www.eurekalert.org/pub_releases/2007-04/plos-dru041907.php and http://medicine.plosjournals.org/perlserv/?requesget-document&doi=10.1371/joumal.pmed.00401508r.cl

Almost 5,000 Canadian 5th grade students were involved in this recently completed study. It was entitled the Children’s Lifestyle and School Performance Study and was con­ducted by researchers at the University of Alberta.

Researchers established that a healthy diet consisted of fruits, vegetables, protein, calcium, grains, a good amount of dietary fiber and a moderate amount of fat. A diet that would be less healthy would have fewer intakes of these items and be heavy in saturated fats and salt. Students were measured in terms of their dietary intake, height and weight and assessed against a diet quality index to summarize the overall diet of each child.

A standardized literacy test was then given to each student. The object of this was to examine the association between the indicators of a good diet or a poor diet and overall aca­demic performance.

Researchers learned that students with the healthier diets were significantly less likely to fail the literacy assessment test. In fact, when comparing the students with the best diet against those with the lowest dietary index scores, the top group was 41 percent less likely to fail the literacy assessment.

“We demonstrated that above and beyond socioeconomic factors, diet quality is impor­tant to academic performance,” said the study authors lead by Paul J. Veugerlers, PhD. “These findings support the broader implementation and investment in effective school nutri­tion programs that have the potential to improve a student’s diet quality, academic perform­ance, and, over the long term, their health.”

This information aligns nicely with an emphasis on a healthy lifestyle and good nutrition for both adults and children as can be provided with a visit to a chiropractor or acupuncturist. This is especially true in the case of a child who has been labeled with Attention Deficit Hyperactivity Disorder. Parents would be very wise to have such a child examined by a natu­ral healthcare professional before taking drugs that are too often prescribed today. A healthy diet and improved nutrition may be all that is needed to put the child on the road to success in school.

Source: The University of Alberta. “Children with Healthier Diets do Better in School.” Press Release. March 2008. http://www.blackwellpublishing.com/press/pressitem.asp?ref=1647

An FDA investigation into hearing loss followed on the heels of a report in the April issue of the Journal of Laryngology & Otology of a man experiencing the problem after taking Viagra^®. The search into the FDA Adverse Events Reporting System turned up 29 cases that involved erectile dysfunction drugs or the drug Revatio^® which is used for control of severe hypertension. In most cases, the hearing loss was accompanied by ringing in the ears, vertigo or dizziness. Usually, the hearing loss involved one ear and resulted in either a partial or complete loss of usual hearing. In approximately one third of the cases the event was tempo­rary, but in the remainder, the hearing loss was ongoing.

Cialis^®, Levitra^® and Viagra^® are the most common types of heavily advertised drugs aimed at helping men with erectile issues. The drug Revatio^® is used to treat pulmonary arte­rial hypertension, a serious medical condition in which continuous high blood pressure in the arteries of the lungs weakens the heart muscle and often leads to heart failure and death, according to the FDA report.

“Because some level of hearing loss is usually associated with the aging process, patients taking these drugs may not think to talk to their doctor about it,” said Dr. Janet Woodcock, M.D., the FDA’s deputy commissioner for scientific and medical programs and acting direc­tor of its Center for Drug Evaluation and Research. The FDA instructions to Cialis, Levitra and Viagra users is to discontinue the drug and immediately seek medical attention if hearing problems develop. Revatio users are instructed to continue taking their medication, but they should contact their healthcare provider for further evaluation. Because Revatio is taken to treat a potentially life-threatening situation, the FDA does not recommend abruptly stopping usage if hearing loss occurs.

The strong relationship demonstrated between the use of these drugs and sudden hearing loss warrants revisions in product labeling, according to the FDA. In the future, Cialis, Levitra, Viagra and Revatio products will bear warnings regarding sudden hearing loss and the course of action to take if such an event happens.

Source: The U.S. Food and Drug Administration, FDA News, October 2007. http://wwwfda.govibbs/topics/NEWS/2007/NEW01730.html

Persons who are leery of accepting flu shots have additional reasons to bypass them this year based on the recent recommendations of a U.S. Food and Drug Administration panel. In a safety review recent­ly released by the FDA’s Division of Antiviral Products, a stronger label warning was urged for two pop­ular flu drugs for which a variety of complaints have been received. It also urged stricter monitoring of children taking these flu medications.

Tamiflu and Relenza are the two drugs for which stronger warnings and monitoring were recom­mended. Tamiflu, produced by Roche, is approved both as a preventative and a treatment for flu in adults and children aged 1 year and older. Relenza, made by GlaxoSmithKline, is approved as both a flu preventative and a treatment in adults and children aged 5 years and older.

According to the FDA safety review, there have been 596 reported cases of psychiatric behavior associated with Tamiflu use. Most of these cases happened among patients aged 21 or younger. The majority (75 percent) occurred in Japan. Fifty-nine of the cases were classified as delirium with impul­sive behavior and self-injury. Delirium, delusions, hallucinations or psychosis accounted for another 225 cases. In total, five children died “as a result of falls from windows or balconies or running into traffic,” the safety review found, and three adults committed suicide, all in Japan.

The FDA safety review also reported that in cases involving Relenza, again mostly in Japan, there have been 115 reports of “delirium with impulsive behavior and self-injury in which the patient expressed ‘fear’ and attempted to flee or expressed a desire to ‘jump,’” the agency said. There were no deaths associated with Relenza.

Both drug manufacture’s defended their product in statements following the hearing. “According to data analyzed from two U.S. claims databases of more than 150,000 patients, there is no increased risk for neuropsychiatric events in influenza patients treated with Tamiflu compared to untreated influenza patients,” the Roche statement said. The GlaxoSmithKline company statement said, “We believe the cur­rent Relenza U.S. prescribing information accurately reflects the safety profile of the drug,” adding that there was “no conclusive evidence of a causal association between Relenza and neuropsychiatric events.”

The best way to battle the flu this season is to keep your body healthy. This can be achieved with a good diet, exercise and Chiropractic or Acupuncture treatments from your local, natural, healthcare providers. Good health comes from within.

Sources: Department of Health and Human Services, Women’s Health, November 2007. http://www.4women.govinews/english/610343.htm and The Center for Disease Control November 2007 http://www.cdc.goviod/oc/media/pressrel/2007N71109.htm

Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group, a national, nonprofit consumer advocacy organization based in Washington, D.C., said the drug clearly causes pre-can­cerous lesions of the colon (aberrant crypt foci or ACF) and its approval for over-the-counter availability is, “the height of recklessness and shows a profound lack of concern for the public’s health.”

The connection of ACF with carcinogenesis is so well-recognized that the appearance of ACF in rats is used by many groups to test the potential carcinogenicity of chemicals, Wolfe said. For example, the Environmental Protection Agency (EPA) uses an ACF assay in its tests of possible carcinogens.

In April 2006, after opposing the OTC switch, Public Citizen petitioned the FDA to ban the pre­scription version of orlistat – Xenical – because of the two studies documenting its ability to cause ACF. There are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.

In opposing the over-the-counter approval a year ago, the Public Citizen said, that “the switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent co-existence of other diseases, common, bothersome (gastrointestinal) adverse reactions, significant inhibition of absorption of fat soluble vitamins (A, D, K and E), and problematic use in the millions of people using the blood thinner warfarin (Coumadin^®) because of orlistat-induced Vitamin K deficiency.”

OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli ^Tm and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program, the FDA said.

“We strongly urge people not to use this potentially dangerous drug,” Wolfe said, “and we pre­dict that, like the rapidly declining sales of the prescription version, the over-the-counter version will turn out to be a loser after enough people have a bad experience with it.

SOURCES: http://www.fda.govibbs/topics/NEWS/2007/NEW01557.html http://www.citizen.org/hot_issues/issue.cfmM=1539

A recently reported study funded by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health examined the results of 69 heart attack-related studies done over the past 35 years. It is most interesting to note that, depending on the size and extent of the study, between 30 percent and 37 percent of women did not have chest discomfort during a heart attack. By contrast, only 17 to 27 percent of all men did not report discomfort in the chest prior to their heart attack.

The main finding of this study, and the warning that comes with it, is that women are much more likely to experience a wider range of symptoms associated with a heart attack than are men. Women should be aware that the following events may be important signals to note that could signal the onset of a coronary attack:

Pain in the middle or upper back, neck or jaw; a shortness of breath; nausea or vomiting; indigestion; loss of appetite; weakness or fatigue; cough; dizziness; or heart palpitations.

The study authors also noted that older people are much more likely to suffer a heart attack that does not include the symptoms of chest pain. This is also important data for women as, on the average, women are likely to be 10 years older than men are when experi­encing their first heart attack.

Maintaining heart health and wellness through exercise, proper diet and avoiding tobac­co are all considered to be important to a person who wishes a long life that is free of coro­nary incident. However, knowing the symptoms that may indicate a heart attack is taking place can also be very important. Being aware and taking heed of symptoms, followed by the proper emergency actions, can have everything to do with surviving a heart incident and living a long and prosperous life in the years to follow.

Source: The National Heart, Lung, and Blood Institute of the National Institutes of Health. December 2007.

http://public.nhlbi.nih.govinewsroom/home/GetPressRelease.aspx?id=2497

Called “Nine patient safety solutions”, the program is WHO’s response to the alarming fact that healthcare errors – avoidable “human errors” – affect 1 in every 10 patients around the world. It is hoped that by distributing these fundamental procedures to all healthcare facilities in all WHO mem­ber nations that the toll of injuries and lost lives will be significantly reduced.

Sir Liam Donaldson, Chair of WHO’s World Alliance for Patient Safety and Chief Medical Officer for England, said: “Patient safety is now recognized as a priority by health systems around the world. The Patient Safety Solutions program of work is addressing several vital areas of risk to patients. Clear and succinct actions contained in the nine solutions have proved to be useful in reducing the unacceptably high numbers of medical injuries around the world.”

The nine solutions are being made available in an accessible form by WHO Member States to re­design patient care processes and make them safer. A not-so-surprising number of the problems involve poor communication:

1. Look-alike, sound-alike medication names: confusing drug names cause deadly errors.
2. Patient identification: failures to correctly identify a patient can lead to harm.
3. Communication during patient hand-overs: new care teams need all patient data.
4. Correct procedure at correct body site: wrong-site surgery is 100% preventable.
5. Control of concentrated electrolyte solutions: these injections are especially dangerous.
6. Assuring medication accuracy at transitions in care.
7. Avoiding catheter and tubing misconnections.
8. Single use of injection devices: multiple needle use leads to infection.
9. Improved hand hygiene to prevent healthcare-associated infection.

The “nine solutions” were derived from interventions and actions that actually solved patient safety problems around the world. More than 50 international experts in patient safety helped identi­fy and adapt the solutions to the needs of different cultures and nations.

“These solutions offer to WHO Member States a major new resource to assist their hospitals in avoiding preventable deaths and injuries,” says Dr Dennis S. O’Leary, president of the Joint Commission. “Countries around the world now face both the opportunity and the challenge to trans­late these solutions into tangible actions that actually save lives.”

SOURCE: World Health Organization, 2 MAY 2007, http://www.jointcommissionintemational.org/24946/

A profound change along these lines is that Medicare will no longer pay the additional costs of cer­tain preventable conditions – including certain infections – that are acquired at the hospital. The New York Times recently reported this as a major change that will take place on Oct. 1, 2008. Preventable medical errors would include such things as infections, bedsores and pressure ulcers. Injuries caused by falls and infections resulting from the prolonged use of catheters in blood vessels or the bladder would also fall into this non-reimbursement category.

This portion of the reforms could require hospitals to greatly improve their quality of service as payments will no longer be Medicare approved for problems caused by the medical provider. Annually, according to the U.S. Centers for Disease Control and Prevention (CDC), approximately 1.7 million patients develop infections in hospitals each year. The CDC estimates that those infections cause or contribute to the death of 99,000 people a year, a total of about 270 hospital infection-related deaths each day.

These figures could translate to major savings for the Medicare program each year, and it will be interesting to see if insurance companies follow suit. While cost savings are certainly a consideration, so is the improved level of patient care. “If a patient goes into the hospital with pneumonia, we don’t want them to leave with a broken arm,” said Herb B. Kuhn, the acting deputy administrator of the CMS.

Additional reforms to the Medicare system have to do with increased payments to hospitals. Payments to all hospitals will increase by an estimated average of 3.5 percent for the 2008 fiscal year. Payments to certain hospitals may increase more or less than this amount depending on the type of patients they serve and their geographic location. Urban hospitals and those who treat more severely ill patients will likely receive higher payments, for instance.

“With these changes – first proposed by the Medicare Payment Advisory Commission in 2005 -Medicare payments for in-patient services will be more accurate and better reflect the severity of the patient’s condition,” said Mr. Kuhn. And, now facing the threat of non-payment for patient problems caused in the hospital, it is hoped that patients will receive greatly enhanced care as a result of these quality improvement efforts.

Source: The Centers for Medicare and Medicaid Services, August 2007. http://www.cms.hhs.govicenter/press.asp and Kid Chiropractic, www.kidchiropractic.com

The FDA has received reports that the drug is responsible for causing behavior/mood changes, suicidality (suicide thinking and behavior) and suicide. The agency has issued a warning to healthcare professionals and users of the drug that it is conducting an investigation even though it is not telling people to immediately stop using the medication.

Singulair is a drug that is used to treat asthma and the symptoms of rhinitis including runny nose, itching of the nose, sneezing and stuffy nose. It is also pre­scribed to prevent asthma that is induced by exercise.

Reports to the drug maker have already caused Merck to take action to update pre­scribing information to doctors and usage information to patients. These updates fall under the area of “post-marketing adverse effects.”

Here are the adversely reported effects for which Merck already executed a series of informational updates in the past year for the prescribing of Singular:

• Tremor, March 2007.
• Depression, April 2007.
• Suicidality, October 2007.
• Anxiousness, February 2008.

The FDA has indicated that it may take up to 9 months to determine the results of this investigation. Regardless of the FDA’s position on Singulair, it is warning both to doctors and to users to be alert to the risk of altered behavior and suicidal thinking.

Singular falls into a category of drugs known as “leukotriene receptor antagonists.” (Leukotriene is a compound that works to regulate allergic and inflammatory reac­tions.) Additional leukotriene modifying medications include the drugs Accolate^®, Zyflo^® and Zyflo CR^®.

According to the FDA, “Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.”

Source: The U.S. Food and Drug Administration. “Early Communication about an Ongoing Safety Review of Singulair.” April 2008. http://www.fda.gov/cder/drug/early_comm/montelukast.htm and http://www.fda.gov/medwAtch/safety/2008/safety08.htmitSingulair

The product in question is the popular soft drink 7UP. It is produced and marketed by Cadbury-Schweppes. The company has announced, under the threat of impending litigation, that it will highlight ingredients “for which there is no debate” over whether or not they are natural and will exclude the controversial factory-made sweetener known as high fructose corn syrup. The lawsuit was being forwarded by the Center for Science in the Public Interest (CSPI).

According to the CSPI, it may sound like high fructose corn syrup comes from corn in the same way sugar comes from sugar cane or sugar beets. However, high fructose corn syrup is creat­ed by a complex industrial process performed in refineries using equipment like centrifuges, ion-exchange columns and back-bed reactors to name a few. Basically, starch is extracted from the corn and then converted by acids or enzymes to glucose. Then some of the glucose is further con­verted by enzymes into fructose.

“Let’s put it this way,” said Michael F. Jacobson, executive director of the CSPI. “Unless you and your chemist friends are prepared to undertake a little Manhattan Project in your kitchen, you won’t be brewing any high-fructose corn syrup from scratch anytime soon.” (The Manhattan Project was the secret code name for the operation that developed the Atomic Bomb in the 1940s.)

The CSPI says that even though the glucose and fructose in high fructose corn syrup are identi­cal to naturally occurring glucose and fructose, the fact that chemical bonds are broken and rearranged in the process disqualifies them from being called natural. For instance, while a scien­tist might be able to produce sugar by rearranging the molecules of any number of things that con­tain carbon, hydrogen and oxygen, it clearly wouldn’t be “natural” sugar.

“We are pleased that Cadbury-Schweppes has fixed what was a flawed and deceptive market­ing campaign and that this issue was resolved without our actually suing,” said CSPI litigation director Steve Gardner. The CSPI litigation unit has encouraged several major food companies including Quaker, Frito-Lay, Procter & Gamble, Tropicana and Pinnacle Foods to halt deceptive labeling or marketing practices. Recently, KFC stopped using partially hydrogenated oils after being sued by CSPI.

Kraft Foods recently announced that it, too, will drop its “All Natural” claims for its Capri Sun drink as it contains high fructose corn syrup. Some additional suits are in the works regarding a green tea drink that claims to be a “calorie burner” and “junk food” being marketed as healthy breakfast cereal.

Source: The Center for Science in the Public, September 2007. http://cspinet.orginew/200701121.html and http://cspinet.orginew/200701121.html

The relationship of serotonin to autism has been investigated extensively, but the implications remain unclear due to conflicting findings. Serotonin levels in autistic individuals tend to be elevated ^{( 2, 3, 8 )}, as are the levels of the serotonin precursor tryptophan ⁽¹¹⁾, with apparent increase in symptom severity correlated with the tryptophan levels. In fact, a hypothesis has been put forward ⁽²⁾ suggesting that there is a maturation defect in the monaminergic systems in autism. Alternatively, however, it may be that the defect in serotonin metabolism is a marker for tendency to experience autism but is not a cause of the disorder. Relatives of autistic children are found to have a variety of serotonin-metabolism disorders, but not the mental disorder ⁽⁹⁾. A serotonin lowering drug, fenfluramine, was tested ⁽¹⁰⁾ in a double-blind placebo-controlled trial, but no obvious therapeutic effect was noted. On the other hand, a test ⁽¹²⁾ of both the dopaminergic antagonist (amisulpride) and the dopaminergic agonist (bromocriptine) did show some effects that might indicate a role of the monoamines in autism symptoms. The evidence thus far points to a role of monoamines in the severity of autism symptoms but it appears that the biochemical imbalance is not the sole disorder leading to autism.

Autism has been correlated with other childhood disorders that are related to brain function, such as attention deficit disorder (ADD), mental retardation, epilepsy, and learning disabilities ⁽⁴⁾. While the specific mechanisms and manifestation of these disorders differ significantly, there is a relatively high incidence of one or more such disorders occurring simultaneously and a similar benefit is claimed to using certain nutritional approaches, such as administering nutritional supplements and avoiding allergens.

Chinese books on pediatrics do not mention autism, and this subject does not appear in the modern Chinese medical journal literature either. In the book Clinical Experiences ⁽⁵⁾, a condition is described as follows: disturbance in mental development, apathy, tardiness of speaking…” which is described as a syndrome of “heart blood” deficiency and the suggested treatment is an herbal formula given as a decoction, consisting of 10 grams each ginseng, ophiopogon, and acorus, 6 grams each of tang-kuei and polygala, 5 grams of frankincense, 3 grams of cnidium, and 1.5 grams of cinnabar. This formula nourishes the heart qi, yin, and blood, vitalizes the heart blood, removes phlegm obstructing the orifices of the heart, and calms the agitation of the heart spirit (shen). This prescription might be compared with the formula recommended in the pediatrics volume of the Encyclopedia of Traditional Chinese Medicine ⁽⁶⁾ for treatment of hyperkinetic syndrome in patients who display symptoms of “changeable interests, divided attention, amnesia, dreaminess, stutter, or problems in formation of phrases and sentences….” The formula is as follows: 12 grams each of pseudostellaria and astragalus, 9 grams each of hoelen, atractylodes, tang-kuei, polygala, acorus, and schizandra, with 15 grams of wheat, 6 grams of licorice, and 10 pieces of jujube. This is basically a combination of Licorice and Jujube Combination (Gan Mai Da Zao Tang), and Astragalus and Zizyphus Combination (Yang Xin Tang), two traditional formulas used for mental disturbance. The new formula tonifies the qi and blood, removes phlegm obstruction of the orifices, and calms the spirit.

In an article ⁽⁷⁾ reviewing basic Chinese medical treatments for mental syndromes, the classical division of mental disorders into “dian” and “kuan” types is made. The dian type refers to taciturn and uncommunicative behavior, dementia, lack of sympathy, apathy, and soliloquy; it refers to the person who turns inward. This is closest to the autistic condition. The kuan type, by contrast, is very aggressive; it refers to the person who acts out, loudly and sometimes violently. The famous physician Zhou Danxi stated “Dian belongs to yin and kuan to yang…both conditions are caused by the entanglement of phlegm in the heart…” The ancient texts also attribute the dian and kuan states to congestion of the seven emotions which generate phlegm and mask and obstruct the orifice of the heart. A general formula for alleviating the phlegm obstruction is made by combining pinellia, magnolia bark, perilla fruit, hoelen, arisaema, curcuma, acorus, polygala, perilla leaf, sinapis, raphanus, bamboo juice, and styrax (liquid). Deficiency of qi and blood also gives rise to the dian condition; for symptoms and signs that include spiritlessness, suspiciousness, melancholy mood, refusal of food, soliloquy, and tendency to cry, the formula recommended contains codonopsis, atractylodes, astragalus, tang-kuei, licorice, polygala, fu-shen, saussurea, ginger, jujube, wheat, nardostachys, fu-shou, citrus, zizyphus, albizzia, polygonum stem, and dragon bone. In the book Clinic of Traditional Chinese Medicine ⁽¹³⁾, a formula for dian type condition (stagnancy of phlegm and qi), the indications include apathy, dementia, muttering to oneself, and the treatment is 12 grams of curcuma, 10 grams each of citrus, pinellia, hoelen, arisaema, chih-shih, polygala, acorus, and cyperus, and 6 grams of licorice.

In the review article ⁽¹⁵⁾ on the classification and treatment of mental disorders, early Chinese writings about various mental syndromes are mentioned. Among them is this commentary attributed to Li Peng in the Ming Dynasty book Entering the Door of Medicine:

The mental disorders is described in but one word: phlegm. These diseases are mostly caused by internal injury and only extremely rarely due to external pathogenic influences. The internal trauma, excessive wetness, inappropriate diet, food stagnation, could produce phlegm fire. Then uprising phlegm fire masks the heart orifices. When the person was frightened or fearful or worried or thinking too much, the fire will become more vigorous and then the spirit will not be able to reside in its house. Then the phlegm would suffocate the empty house.

The formulas described above clear out the accumulated phlegm and help prevent formation of additional pathological phlegm. It is important to recognize, however, that adverse dietary practices can overcome the impact of the herbs.

Discussing specifically the dian type of mental condition, it is said ^{(13, 15)} that it is mostly caused by traumatic injury to the seven emotions. The injured emotion will lead to heart fire, obstruction of liver qi, and failure of the ascending of the spleen qi. When qi becomes stagnated, the body fluid will accumulate and condense to form phlegm. The uprising of phlegm will interfere with and cloud the spirit. As an example of a specific treatment, the following herbs are suggested: 12 grams of hoelen, 9 grams each of pinellia, citrus, chih-shih, bamboo, cyperus, and polygala, 6 grams each of curcuma, acorus, saussurea, and licorice, plus 3 slices of fresh ginger.

To what extent might these theories and treatments for a yin-type mental disorder apply to the autistic child or adult? Many of the discourses on mental disorders by Chinese doctors refer to people who develop the mental syndrome after being relatively normal, but are then influenced by some events. While this may be the case in some autistic children, current Western investigations suggest that there is a physical and biochemical disorder present at birth. However, the severity of symptoms can be modulated in many children by diet, nutrition, and drugs, and therefore Chinese medical treatments for similar symptoms acquired in individuals through various experiences (which would affect the biochemistry rather than the physical structures of the brain) may be applicable.

Which particular combination of herbs, though, might work best for an autistic child? One can not know until something has been tried. The only report available to us on treatment of autism with Chinese herbs is an informal communication from a medical doctor in Belgium who had studied with this Institute. He claimed that he had obtained a notable favorable response in several autistic children using the prepared Bamboo and Ginseng Combination (Zhu Ru Wen Dan Tang). This formula contains bamboo, licorice, coptis, bupleurum, hoelen, ginger, pinellia, ginseng, cyperus, citrus, and chih-shih. As with the formulas mentioned above, it includes digestion-promoting, phlegm-resolving, and sedative herbs. Unlike some of the above, it contains none of the blood tonic herbs. The report of effectiveness was made several years ago, and the Institute does not have current contact with this physician.

More recently, a formula for treatment of ADD was developed by ITM, called Acorus Tablets ⁽²¹⁾, and several informal reports of effectiveness were obtained from practitioners who gave it to their patients. This formula contains acorus, polygala, fu-shen, alpinia, curcuma, rehmannia, dragon bone, dragon teeth, oyster shell, bamboo sap, tortoise shell, and succinum. Like the above formulas, it contains herbs for resolving phlegm, sedatives, and blood tonics, but it contains only one herb for promoting digestive functions (alpinia). This formula was based on the claimed effective use of similar combinations for the treatment of ADD in China. In the treatment of epilepsy in children, similar formulations are used, with an emphasis on resolving phlegm obstruction. Another combination ⁽²¹⁾ produced by ITM, Cyperus 18, was designed to treat mental depression that arose from the syndrome of heart fire, liver qi stagnation, and poor conductance of food essence by the spleen, with resultant phlegm obstruction. This formula contains cyperus, perilla leaf, bamboo, uncaria, saussurea, bupleurum, aurantium, fu-shen, pinellia, chih-shih, coptis, ginseng, ophiopogon, tang-kuei, cnidium, ginger, arisaema, and licorice. Informal reports have indicated that it is often successful. As an example, a patient at our own clinical facility (under treatment for multiple sclerosis) had used antidepressive drugs for eight years, but was able to discontinue the drugs after use of this formula for less than six months.

Given the limited experience thus far and the commentaries from ancient and modern writers about treatment of mental disorders, including childhood problems such as ADD, mental retardation, and epilepsy, it would appear that the most likely approach to prove helpful is to utilize the phlegm-resolving herb compounds. It is possible that the digestion-promoting and qi and blood tonic therapies used in China accomplish a function similar to the use of vitamin and amino acid therapies in the West. Since the latter have been tested and appear safe and somewhat effective, one may decide to utilize the Western nutritional approach and the Chinese method of removing “phlegm obstruction.”

The most frequently used herbs for treating phlegm obstruction that causes mental disturbance are polygala and acorus. Polygala has a long-standing reputation in China for improving mental conditions. According to British doctors ⁽¹⁶⁾ who visited China during the previous century, polygala “is supposed to have a special effect upon the will and mental powers, giving strength and character, improving the understanding, strengthening the memory, and increasing the physical powers.” Acorus is reported ⁽¹⁷⁾ to be effective in the treatment of epilepsy of the phlegm-dampness and phlegm-heat types, being of benefit in 80% and 55% of cases respectively. It is similarly reported that if acorus is added to a basic sedative formula, it is effective in treating melancholia and that “patients abandon the idea of suicide by taking about 7 doses of the decoction.” In a book ⁽¹⁸⁾ reviewing the current uses of commonly prescribed Chinese herbs, both acorus and polygala are mentioned as treatments for epilepsy and mental disorders, with acorus specifically mentioned as valuable in the treatment of children. In another book ⁽¹⁹⁾ reviewing the modern use of herbal formulas, it is mentioned that the combination of arisaema, polygala, and acorus are added to other formulas for the symptomatic treatment of “spiritual inertia.”

Of course, when a skilled practitioner is available to access the needs of the autistic child, it might be determined that qi and/or blood tonics, or other herbs are needed. These would especially be suggested if the child is growing slowly, is pale, or has a weak pulse. A suggested herbal combination based on the above considerations would be comprised of ginseng, hoelen, pinellia, citrus, ginger, jujube, licorice, acorus, polygala, tang-kuei, fu-shen, and bamboo. For convenience of obtaining herb supplies and administering herbs in pill form (if desired), this combination could be approximated by using Er Chen Wan (traditional formula made as a patent medicine) plus Acorus Tablets (child size tablets).

Some Chinese herbs have been shown to reduce serotonin levels or inhibit the action of serotonin ⁽²⁰⁾. Serotonin is a mediator of pain signals, and analgesic herbs sometimes function via reducing the signal transmission. Diterpene alkaloids, such as aconitine (from aconite) and methysergide, block the effects of serotonin. Rauwolfia alkaloids, such as reserpine and rhynchophylline (from uncaria), deplete serotonin. Volatile oils from asarum and acorus also lower serotonin levels (the active constituent in acorus is asarone). Of these herbs, only acorus is frequently mentioned in the formulas above, though uncaria is often used in treating mental disorders (included in Cyperus 18), and is used in children’s remedies. A formula comprised of aconite, dry ginger, cinnamon bark, and licorice was utilized ⁽¹⁴⁾ in treating dian-type schizophrenia characterized by little change in facial expressions, dull eyes, decrease in self-initiated movements, inability to love, talking little and having sentences with little content or unfinished, and lack of interest in socializing. the recommended dosage of aconite was quite high. It is possible that the serotonin-inhibitors reduce the symptoms of the dian type mental disorders. To obtain a serotonin-inhibiting action, the dosage of the herbs may need to be higher than is often recommended for treating other disorders. The need to use high dosages is also the situation with nutritional supplements applied in Western studies of autism.

In a review of vitamin B6 and magnesium supplementation trials provided by the Autism Research Institute, the dosage of the vitamin administered covered a wide range, but was typically 30 mg/kg/day up to about one gram per day, and magnesium dosage was typically 10-15 mg/kg/day, up to about 500 mg. These levels far exceed what is available from dietary sources. Glycine, in the form of dimethylglycine, is recommended in dosages of 125-500 mg/day, starting with a low dose and increasing gradually to minimize the occurrence of hyperactivity in response to initial dosing.

Due to the lack of familiarity of most Westerners with Chinese herbs, leading to questions about their safety, efficacy, method of application, and duration of use, it can not be expected that Chinese herb formulas will be widely utilized in the treatment of autism, especially in young children. However, there is sufficient evidence that Chinese physicians have had experience and some success in treating mental disorders similar to autism (perhaps sometimes autism itself), so that it is a method that should be pursued with due caution along with the recommended dietary and nutritional approaches. There are several herbal formulas which have been used extensively in the West without significant adverse effect that can be used as the starting point for experimental treatments.

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