A study published in the September 13, 2006 issue of the Journal of the American Medical Association (JAMA) starts off with a chilling statement. “Much of pediatric drug use is off-label because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children.” In other words, according to the authors in JAMA, most of the drugs being sold for children have not been approved by the FDA for use in children.

The study, also reported on in a September 13, 2006 Associated Press story, notes that very little of the research that is done gets published in scientific journals. This then makes it hard for doctors to know about the medications or the study results. Dr. Danny Benjamin, an associate professor at Duke University who led the study and also works for the U.S. Food and Drug Administration commented, “Ironically, some of the times when drugs do work (in children), they’re still not getting published.”

Dr. Benjamin noted that many of the studies that do get done are never submitted for publication in journals. Dr. Catherine DeAngelis, JAMA editor-in-chief noted in the AP story that few studies submitted to JAMA involve the effects of medication on children.

It is not known if the reason for these lack of submissions is the change in 2004 by many of the scientific journals that now require drug tests be pre-registered before the testing in order to be considered for publication after the tests are complete. The reason the publications did this was because drug companies were running multiple studies on some drugs then only publishing the best results from drug trials while hiding the ones that may not have been so successful. Gregory D. Curfman, executive editor of the New England Journal of Medicine explains the rationale by stating, “When a pharmaceutical company sponsors a clinical trial and the results turn out not to be in the best financial interests of the company, it has been our experience these results are never made public.”

By not submitting the pediatric drug tests for publication in the journals, the drug companies could conceivably bury those tests that were not favorable, while distributing only those that seemed to work. In response, Scott Lassman of Pharmaceutical Research and Manufacturers of America, noted that drug companies often present data at medical conferences and or post them on an online industry database. This type of dissemination does not undergo the same scrutiny as publication in a peer reviewed scientific journal.

A November 7, 2001 report on a study conducted by the International Chiropractic Pediatric Association showed that a chiropractic technique known as the “Webster Breech Turning Technique” was statistically very successful in resolving breech pregnancies without medical procedures. A Breech pregnancy is when the baby is not properly positioned in the mother’s womb near the date for delivery. If the baby is not positioned head-first, the delivery may be difficult or even dangerous for both the mother and child.

This chiropractic technique was created by the late Dr. Larry Webster, who was affectionately known as “The grandfather of chiropractic pediatrics.” The study entailed surveying members of the International Chiropractic Pediatric Association, Inc (ICPA – www.icpa4kids.com) throughout the United States and Canada. The survey noted that there were a reported 112 cases of breech recorded by the chiropractors. Of these, the results were 102 positive resolutions. This means that in 102 of 112 cases the baby turned properly after the chiropractic procedure was performed. This represents a success rate of almost 92%!

The conclusions of this study clearly stated, “When successful, the Webster Technique avoids the costs and/or risks of either, ECV, cesarean section or vaginal trial of breech. In view of these findings the Webster Technique deserves serious consideration in the health care management of expectant mothers exhibiting adverse fetal presentation.”

An article in the December 6, 2007 issue of the New England Journal of Medicine (NEJM) calls for the US Food and Drug Administration (FDA) to take action concerning over the counter pediatric medications targeted at children under 12 years of age. “We believe that it (FDA) should immediately ask companies to remove these products from store shelves and begin legal proceedings to require them to do so.”

The original NEJM article by by Joshua M. Sharfstein, M.D., Marisa North, B.A., and Janet R. Serwint, M.D., highlights some very interesting facts related to over the counter drugs being advertised for children. The article notes that, “Since 1985, all six randomized, placebo-controlled studies of the use of cough and cold preparations in children under 12 years of age have not shown any meaningful differences between the active drugs and placebo.”

The NEJM article noted that as far back as 1997, the American Academy of Pediatrics created a policy statement on cough medications stating “indications for their use in children have not been established.” Additionally, the authors of the article noted that as recently as 2006, the American College of Chest Physicians stated that “literature regarding over-the-counter cough medications does not support the efficacy of such products in the pediatric age group.”

Some additional and chilling statistics brought forth in the article note that since January of 2000 there have been 750,000 calls of concern related to cough and cold products to poison-control centers. Additionally they reported that the US Centers for Disease Control and Prevention in 2004 and 2005 identified more than 1500 emergency room visits for children under 2 years of age related to cough or cold products.

The article notes that in 1976, the FDA adopted a system for determining children’s medications doses using a crude formula. This formula simply determined the use of pediatric medication by age only. For children between 6 and 11 years of age, the formula said that medications should be dispersed based upon half the adult dose. For children between 2 and 5 years of age, the formula recommended a quarter of the adult dose. The NEJM article notes that this very crude formulation was not based upon any science and has not been changed for over 30 years.

Interestingly, the New England Journal of Medicine article was also reported in several Canadian news outlets but NOT in any major US news publications. In a December 06, 2007 article in the Canadian National Post, Dr. Michael Rieder of the Canadian Pediatric Society commented on the importance of this NEJM article by stating, “Every regulator in the world will pay attention to [the article], and because we share the same unprotected border, Canada will pay more attention than other countries. The pressure has been building to this for over the past 12 to 18 months, and people in the community are saying, ‘Let’s get this done.'”

In an article from Reuters Health Information, printed in the Journal of the AMA is a report of a survey that showed many children with asthma were seeking what the article termed, “complementary medicine” for their problem. Dr. Sheldon Spier, of Alberta Children’s Hospital in Calgary, surveyed the parents of 117 pediatric asthma patients. Thirty percent reported using complementary medicine to help manage their children’s asthma symptoms, most commonly herbal medications, chiropractic, homeopathy, and vitamin C supplementation. One of the common reasons given for the usage was, the non-medical practitioners were perceived as “treating the whole patient.”

The International Chiropractic Pediatric Association lists several studies on their web site ( www.icpa4kids.org ) discussing the benefits of chiropractic for children with asthma. The following are some of those excerpts: “76.5% of patients with bronchial asthma said they benefited from chiropractic treatment. Peak flow rate and vital capacity increased after the third treatment. Significantly lower quality of life impairment rating scores were reported for 90.1% of children after 60 days of chiropractic care. During this same time period the average number of asthma attacks decreased an average of 44.9%, and asthma medication usage was decreased an average of 66.5%. Among parents of asthmatic children who had received chiropractic treatment, 92% considered this treatment beneficial.”

In an article from Reuters Health Information, printed in the Journal of the AMA is a report of a survey that showed many children with asthma were seeking what the article termed, complementary medicine for their problem. Dr. Sheldon Spier, of Alberta Children’s Hospital in Calgary, surveyed the parents of 117 pediatric asthma patients. Thirty percent reported using complementary medicine to help manage their children’s asthma symptoms, most commonly herbal medications, chiropractic, homeopathy, and vitamin C supplementation. One of the common reasons given for the usage was, the non-medical practitioners were perceived as treating the whole patient.”

The International Chiropractic Pediatric Association lists several studies on their web site ( www.icpa4kids.org ) discussing the benefits of chiropractic for children with asthma. The following are some of those excerpts: 76.5% of patients with bronchial asthma said they benefited from chiropractic treatment. Peak flow rate and vital capacity increased after the third treatment. Significantly lower quality of life impairment rating scores were reported for 90.1% of children after 60 days of chiropractic care. During this same time period the average number of asthma attacks decreased an average of 44.9%, and asthma medication usage was decreased an average of 66.5%. Among parents of asthmatic children who had received chiropractic treatment, 92% considered this treatment beneficial.

A study published in the December 2009 issue of the scientific periodical, the Journal of Clinical Chiropractic Pediatrics shows that chiropractic care is extremely safe for children. In research for this report, the study author undertook a review of all previously published reports of “adverse events” for chiropractic care delivered to children.

In this study the author, a chiropractor from the Anglo European College of Chiropractic, and lead tutor for Advanced Practice for Chiropractic Pediatrics, Joyce Miller, B.Sc., D.C., D.A.B.C.O., set out to review and examine the chiropractic safety record for care of children in comparison to the safety record of medications given to children. She noted that the safety issue of medications given to children is an increasing concern.

In her published study, Dr. Miller reported that according to the United Kingdom’s, National Patient Safety Agency, in 2006 out of a total of 33,446 reports of medical pediatric care, 19% experienced a medication problem, 14% had a procedural safety breech, 9% showed errors in documentation, and an additional 7% had errors in medical clinical assessment.

The reported results of the authors research showed that there were six separate published reports that addressed safety of what was called “Manual Therapy” for children delivered by either chiropractors or medical practitioners. The author specifically looked at the care rendered by chiropractors for the purpose of this study.

The results showed that over a 59 year time frame, a systematic review of the literature only uncovered 8 incidences of hurt or harm to children due to chiropractic adjustments. With an estimated 30 million pediatric adjustment visits to chiropractors made each year, the risk factor is calculated to be extremely low.

In her conclusion, Dr. Miller wrote, “Based on the published literature, it appears that manipulation, when given by a skilled chiropractor with years of training carried out with low forces recommended for pediatric care, has few side effects in the healthy infant and child and their recorded incidence is exceedingly low.

From the July 2008 issue of the scientific periodical, the Journal of Manipulative and Physiological Therapeutics (JMPT) comes a 3-year retrospective study of pediatric case files from the Anglo-European College of Chiropractic (AECC) teaching clinic practice in Bournemouth, England. This JMPT study reviewed 781 pediatric cases of children younger than 3 years of age to see if there were any adverse side effects of chiropractic care on children.

The authors of this study also reviewed previous literature to look for reports of any adverse events related to chiropractic care for patients under the age of 18. In this review they found a total of 9 events of problems that could have been related to chiropractic care for all the years between 1969 to 2001. Using the number of children under care in that time period and the number of chiropractic visits for those children the authors estimated that the risk of an adverse effect was 1 in 250 million.

In their more current review, the authors of the study looked at 781 cases of children younger than 3 years of age between January 2002 to December 2004 that received care at the Anglo-European College of Chiropractic (AECC) teaching clinic. Each of these cases was reviewed and information was recorded on how many chiropractic adjustments were received, the type of care rendered, the outcome of care, and whether any negative side effects were reported.

The study noted that of the 781 pediatric patients who presented for examination, 462 (59.15%) were male and 319 (40.85%) were female. Most (73.5%) patients were 12 weeks or younger of age (n = 574). The most common age group was between 5 and 8 weeks of age. They also reported that most infants were brought in for care by their parents because of problems with colic or irritability that was attributed to birth trauma.

In this review 699 (89.5%) received chiropractic care, and 82 (10.5%) were referred out to seek help elsewhere. Of the 699 initial children, a follow up was made on 697. Of these children, the parents of 594 (85.22%), reported an improvement in their child’s original symptoms. One hundred three (14.78%) parents reported that there was no change in their child’s symptoms. Of the total of 697 pediatric patients whose parents reported outcomes to care, there were 7 cases in which the parents reported some form of an adverse reaction to care. This translates into approximately 1% of patients experiencing some form of a negative side effect.

The study noted that all of these negative reactions were mild and required no medical care. The study also noted that there were no serious complications resulting from chiropractic care. The researchers stated in their conclusions, “This study provides evidence that chiropractic treatment is a safe form of therapy for children younger than the age of 3 and documents that there were no serious complications resulting from chiropractic manipulation in this group of children of this age range.”

A documented case study appeared in the scientific periodical, the Journal of Pediatric, Maternal & Family Health on August 11, 2011 showing chiropractic helping an 8-year-old boy suffering from headaches. The study authors begin by noting that about 75% of children report a notable headache by age 15.

The authors report that cervical (neck) subluxations, and the resulting changes in cervical curves have been shown to be a factor in headaches. Past studies show that people with necks that do not have their normal forward curvature and have become straight or reversed are particularly prone to headaches.

In this study, the 8-year-old boy was brought to the chiropractor with complaints of headaches, muscle aches, fatigue, allergies, and digestive problems. The boy’s headaches were described as sharp and throbbing, and were made worse with noise, but improved when he was lying down. The boy’s headaches were mainly in the front of his head and would last the entire day, sometimes even waking him at night.

Over the previous year, the boy’s health continued to decline, and he became less able to engage in normal activities that he had previously enjoyed. In response, his parents had taken him to a pediatric neurologist-headache specialist, an allergist, a nutritionist, and a psychologist. Recommendations and medications from the medical health practitioners gave little or no relief to the boy.

A chiropractic examination and x-rays were performed, and revealed subluxations with cervical curve changes in the neck area. Chiropractic care was initiated with the child initially being seen three times per week and gradually reduced in frequency.

As a result of the chiropractic care, the child’s headaches were alleviated and post x-rays showed an improvement of the neck curvature. The boy was involved in an auto accident later in his care. Fortunately, his headaches did not return, and he suffered no ill effects from the incident.

In the discussion area of the study, the authors conclude by stating, “It seems that evidence points to the cervical spine and its alignment as a critical factor in the diagnosis, treatment and prevention of cervicogenic headache in the pediatric population.”

A story initially appearing in the November 11, 2007 issue of the Baltimore Sun, titled, “Untested medicine” exposed the fact that, as author Stephanie Desmon stated in her article, “Most drugs given to children have never been tested for them, forcing physicians to sometimes use a best guess in determining dosing, efficacy and even safety.”

The article notes that children are not small adults and that their bodies’ process medications differently than do adults. Sometimes the medication goes into action faster and sometimes slower. The article also noted that some medications for adults are actually poisons for children. Dr. Joseph M. Wiley, chief of pediatrics at Sinai Hospital in Baltimore commented in the article how difficult it is to prescribe medication for children that has only been tested on adults, “If you extrapolate from an adult dose to a pediatric dose, you may be right … you may be wrong.”

Attempts to correct this problem have been made by laws being passed, however, the article notes that according to the Government Accountability Office, the investigative arm of Congress, that as of this year only about one-third of the drugs prescribed for children have been studied and labeled for pediatric use.

When studies were done it was found that the effects of drugs on children were much different than that on adults. Dr. Dianne Murphy, director of the Food and Drug Administration’s office of pediatric therapeutics, stated, “We found out that you can’t predict how kids are going to handle things.”

The article explained that once a medication has been approved for use in adults, it can then be legally prescribed to anyone at any age. The practice of prescribing drugs to groups it was not approved for is common and is known as “off-label” prescribing.

A study that confirmed this off-label use was published in the March 7, 2007 issue of the scientific journal the Archives of Pediatrics & Adolescent Medicine. In that study, referenced in the Baltimore Sun article they stated in their conclusions, “Most patients hospitalized at tertiary care pediatric institutions receive at least 1 medication outside the terms of the Food and Drug Administration product license. Substantial variation in the frequency of off-label use was observed across diagnostic categories and drug classes. Despite the frequent off-label use of drugs, using an administrative database, we cannot determine which of these treatments are unsafe or ineffective and which treatments result in substantial benefit to the patient.”

A good source of information on Chiropractic and children is the website of the International Chiropractic Pediatric Association (ICPA). Their web address is www.icpa4kids.com. This site contains articles, information and research on health related issues concerning children. Their mission statement reads, “The mission of the International Chiropractic Pediatric Association is to bring the life saving benefits of chiropractic care to all children.”

Their website contains information for the general public about the benefits of chiropractic care. In one section, entitled, “Why chiropractic for children”, the ICPA discusses such issues as “Why should children have chiropractic care” and “Is chiropractic safe for my child”. The articles on this site are well referenced and thorough.

In addition to articles and information about chiropractic for infants and children the ICPA website also contains a vast resource of information on subjects that relate to child health and well being in general. Subjects such as ADHD, Asthma, Child safety, Scoliosis, Speech disorders, and many other topics are presented in articles and research in language that is easily understood. Additionally their website contains links to other health related sites on such subjects as natural child birth and vaccinations.

Two other sections that are well laid out and informative are the sections on family wellness and research. Each of these sections has large numbers of pages of pediatric health related information. If you are making critical decisions about the health and well being of your children or family, you should consider the website of the ICPA for valuable information.