Tag Archives: american academy of pediatrics

To Be or Not to Be (Vaccinated)?

For many years, Americans did not need to worry about contracting the once-widespread disease called the measles. In fact, the Centers for Disease Control and Prevention (CDC) officially declared measles eliminated in the U.S. in 2000. Unfortunately, that is no longer the case. In January 2015 alone, there were already more confirmed cases in the U.S. than are typically diagnosed in a full year. Public health officials are very concerned and have moved to aggressively contain this very contagious, but 100% preventable, disease. The current outbreak and surge in confirmed cases of measles, most notably in California, has been scientifically linked by researchers from MIT and Boston’s Children Hospital to the outbreak that began in Disneyland in December 2014. Medical researchers believe the spread of the current measles outbreak is solely because of low vaccination rates in certain communities based on a widespread but false link between childhood immunizations and autism. International health officials have called the link between the MMR (measles, mumps and rubella) vaccine and autism “the most damaging public health hoax in the past 100 years.”

Just last week on April 21, the Journal of the American Medical Association (JAMA) released the findings of a comprehensive study using the health insurance data base of 95,000 children and found no overall link between autism and the MMR vaccine. The study also found no link for children with an autistic sibling. The study did find a lower vaccination rate for the younger siblings of children with autism based on parents’ continued fears of a link. The JAMA study authors from the Lewin Group in Falls Church, Va., stated; “Consistent with studies in other populations, we observed no association between MMR vaccine and increased ASD (autism spectrum disorder) risk among privately insured children.”

Despite the overwhelming medical evidence that the MMR vaccine is both very safe and highly effective, anti-vaccination groups still dispute the facts and are warning parents not to be pressured into having their children vaccinated, which is the crux of this public health problem. On the same day that the JAMA study was released, CBS Evening News ran a segment on the current U.S. Surgeon General Vice Admiral Vivek Murthy, MD, MBA, or “America’s Doctor,” who appeared on Sesame Street to promote childhood vaccinations. CBS closed the segment with; “Vaccination critics don’t see anything cute about this video after the controversy over the recent measles outbreak.” Really? There is no controversy. It was all based on a documented hoax.

The original belief that vaccinations cause autism was based on a reported study in 1988 by Dr. Andrew Wakefield in the U.K., which has since been 100% completely discredited. His report unnecessarily panicked many parents around the world, causing a sharp decline in the number of children getting the MMR vaccine. The false claims and widespread panic began when a British medical journal, the Lancet, published Wakefield’s article. It was later determined that the author had multiple conflicts of interest, had manipulated evidence and had broken ethical research codes of conduct, including accepting funding by attorneys involved in lawsuits against vaccine manufacturers. The Lancet fully retracted the article, but not until 2010, when the editor-in-chief stated that the link was “totally false” and that the world-famous medical journal was “deceived.” The Canadian Medical Journal in 2010 went on to state that the original research included a “callous disregard” for the “carefully selected” study group of only 12 children and that “several elements of this research were incorrect and contrary to findings of an earlier investigation.” Dr. Wakefield subsequently lost his license to practice medicine in the U.K as a result of this fraudulent research.

These are the facts that parents need to know about the measles. Symptoms typically begin with a high fever, runny nose, sore throat and cough, which can easily be misdiagnosed as a simple cold or the flu. The incubation period is between seven and 18 days of exposure to the virus. It is very dangerous because people are contagious up to four days before the red rash appears and likely do not know they are infected. In addition, a room can still be contaminated as long as two hours after an infected person leaves. A single infected person can spread the disease to between 11 and 18 people. An unvaccinated person has a 90% chance of infection if exposed to the virus. The risk of serious complications and death is even greater for adults and infants than for children and teenagers. Rubella, known as the German measles, is also caused by the virus and is usually a mild form of the disease but is a very serious infection that causes miscarriages, still births or birth defects in unborn children when pregnant women get the disease.

Most people born prior to 1957 had the measles. The disease was once so prevalent that in New York City, in the first 10 weeks of 1933 alone, there were 10,000 cases and 434 deaths. The first vaccines developed began in 1958 and became widely available in 1963. Prior to 1963, there were three to four million cases of measles reported each year in the U.S., with 400 to 500 reported deaths annually.

Although many parents in the anti-vaccination movement believe the measles is not dangerous and the MMR vaccine is, the medical facts state otherwise. In fact, from 2001 to 2013, 28% of children in the U.S. with the measles had to be hospitalized. Public health officials fear that many more cases will develop from this outbreak of a very preventable disease, unless aggressive public health measures are undertaken. What is required is an extensive education campaign including widespread vaccination of the unvaccinated U.S. population, starting with infants at 12 months and a booster shot at age four to six, prior to pre-school or kindergarten. Unvaccinated adults also need to be vaccinated.

There are a number of myths associated with the measles vaccination that keep some parents from protecting their children. The controversy surrounding the anti-vaccination movement is based largely on parents’ philosophical beliefs against the vaccination. Dr. James Cherry, a pediatric infectious disease expert at UCLA, believes that the recent outbreak in California is “100% connected to the anti-immunization campaign.” He went on the say that there are “some pretty dumb people out there.”

Medical researchers from MIT and Boston Children’s Hospital documented that the rapid spread of measles from the Disneyland outbreak, beginning in mid-December 2014, indicated a significant percentage of the population exposed had low vaccination rates. These researchers determined that the exposed population rate might have been as low as 50% and likely no higher than 86%. These rates are well below the 96%-99% level known as “herd immunity,” which is required to prevent future outbreaks.

The anti-vaccination movement includes those parents who believe that there is no medical risk from not vaccinating their child, that the disease is extinct, that doctors and drug companies push vaccinations for their own profit, and that you can get the measles from the vaccination. Still others believe the false and discredited link to autism. For the parents who are against vaccination, they not only put their own children at risk, they dramatically increase the risk for the general population who are unable to get the vaccination, such as infants under the age of one, and children and adults with weak immune systems, including people with cancer and other diseases.

Measles is still widespread throughout the world. Travelers from overseas continue to bring the disease into the U.S on a daily basis. The anti-vaccination conspiracy movement belief that doctors and insurance companies promote the vaccination to increase profit is absurd and is negated by the fact that health insurance companies pay for the vaccinations at no cost to the patient. Similar to the flu shot that is a dead virus from which someone cannot get the flu, it is almost impossible to get the measles from the MMR vaccine.

The CDC states there is a 1 in 3,000 chance of a mild allergic reaction to the MMR vaccine but a 90% chance of infection if an unvaccinated child is exposed to the virus. Parents should do the math. In addition, a blood product containing an immune globulin is available for people who are medically unable to immunize with the MMR vaccine for any reason.

What parents need to know is that the scientific community has found no evidence whatsoever of a link between MMR vaccine and autism or any other childhood development disorder. In addition to the just-released JAMA study, large epidemiological studies conducted by the CDC, the American Academy of Pediatrics, the Institute of Medicine at the U.S. National Academy of Sciences and the U.K. National Health Services all found no link between MMR and autism. This original false research has done significant damage to the field of public health and has done serious harm to children of parents who were misled by this report, which resulted in unnecessary deaths, severe impairment and permanent injury in unvaccinated children. Because of wide dissemination of this discredited link, there were many lawsuits by parents with children with autism, but a special court convened by the National Vaccination Injury Compensation program denied all compensation claims in U.S. federal court against manufacturers of the vaccine in 2009.

The recent measles outbreak in California is what has spiked the “controversy” over vaccinations, which has made the national news in 2015 including; CNN, the New York Times and Time Magazine. There have been 178 documented new cases of the measles by late March by the CDC, including five unvaccinated Disneyland workers in Orange County, and the outbreak is now spreading across the U.S.

Although traditional public health issues are typically rooted in poor or rural areas of the country, this current measles outbreak is concentrated in wealthy neighborhoods in California and surrounding states. Although it is reported that only 3.1% of parents in California refuse to vaccinate their children, for health or religious reasons, this number is misleading. In fact, many areas within California have double-digit exemption rates from vaccinations, with some areas as high as 50%.

The MMR vaccination is the best way to prevent disease both for the individual and the general population. It works by making the body produce anti-bodies against the virus. The measles vaccination is recommended for all people 12 months of age or older, and especially people traveling overseas. MMR vaccinations are supported by the American Academy of Family Physicians, American Academy of Pediatrics, the Centers for Disease Control and Prevention and the Mayo Clinic, to name just a few.

An extensive education campaign is required to overcome false and unfounded fears among parents of unvaccinated children. Legislation is needed to strengthen immunization laws requiring all school-age children to receive the measles vaccination, except for those with a medical exemption certified by a licensed physician. Public health officials should also track and verify both statewide and local immunization rates and should mandate that schools maintain an up-to-date list of pupils with exemptions so they can be excluded quickly if an outbreak occurs, temporarily exclude unvaccinated students and teachers from attending school and offer measles vaccinations for unvaccinated students and teachers.

The MMR vaccine is 99% effective and provides immunity for a lifetime. It was once considered one of the major public health campaign success stories. Now, health officials fear the potential for a public health crisis based on blatantly false research and unfounded fears. The CDC points out that people who refuse to vaccinate usually live in the same community. “When measles find its way into these communities, outbreaks are more likely to occur.” Consumers and parents should confirm with their doctor that they or their children do not have any allergic reactions to other medications. They should also verify that they do not have an immune deficiency condition, which may cause side effects and decrease the vaccine’s usefulness.

The myth that childhood vaccinations lead to autism was based largely on a completely discredited medical research hoax. This myth is still being widely perpetuated today not only by the anti-vaccination conspiracy movement led by Hollywood celebrities but also by the mainstream media.

My heart breaks for the parents of children with autism, including a close family friend. But it breaks my heart even more knowing that thousands of children are unnecessarily exposed to unimaginable consequences of birth defects and death from something so preventable. Parents need to listen to the Surgeon General, the CDC, the Mayo Clinic and the American Academy of Pediatrics and not Hollywood celebrities with zero background in public health.

I would like to thank my research assistant and co-author Ms. Chandler Berke who is a public health/science undergraduate student at the College of Charleston in South Carolina.

Winning the War Against Opioid Addiction and Abuse

As we move forward with winning the war against opioid addiction, it can sometimes be challenging to read the daily headlines and stay positive, especially around the holidays. A December article titled “Drug Abusers May be Injuring Pets to Get Pain Killers” shared how police officers and community leaders informed the Ohio attorney general’s office that people have been abusing drugs rightfully prescribed to pets. The US News HealthDay story titled “Secure Your Prescription Drugs When Hosting Holiday Parties” warned readers about the importance of securing prescription drugs in a safe location before guests arrive. When stories deteriorate to addicts intentionally harming their dogs and to people worrying about holiday guests raiding medicine cabinets, rock bottom isn’t far away.

However, 2013 positioned us well for achieving improved results during 2014. Some of last year’s positive developments include:

1.   State law changes establishing clearer standards of care, reporting and tracking of controlled narcotics, bans on abused narcotics, etc.

2.   State and federal agencies aggressively prosecuting individuals who prescribe opioids illegally or  operate “pill mills,” revoking registrations of some pharmacies and compelling healthcare providers and pharmacies to surrender or forfeit their medical licenses to state medical/pharmacy boards

3.   Physician-led education efforts like the Physicians for Responsible Opioid Prescribing

4.   Medical boards actively addressing the inappropriate and illegal dispensing of drugs

5.   Heightened awareness of the neonatal abstinence syndrome crisis in the U.S.

6.   Workers’ compensation insurers leveraging advanced analytics, physician education efforts, evidence-based pain diagnoses and utilization reviews to reduce injured worker reliance on addictive prescription drugs

7.   The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy

8.   The issuance of the October 2013 Trust for America’s Health report titled “Prescription Drug Abuse: Strategies to Stop the Epidemic”

9.   Continuing prosecution and sentencing of healthcare providers

10. Efforts by national medical organizations

The first eight developments were addressed in the authors’ first quarter 2013 Physician Insurer magazine article titled “The Opioid Abuse Epidemic, Turning the Tide” and our Dec. 2, 2013 Property Casualty 360 Claims Magazine article titled “10 Strategies to Combat the Rx Abuse Epidemic – An Insurers Perspective.”

This article will expand on the last two developments and share some thoughts on what may be in our future when it comes to winning the war on opioid addiction and abuse.

Prosecution and sentencing of healthcare providers

2013 was marked by the successful prosecution and sentencing of healthcare professionals involved in various forms of prescription drug diversion. Arguably the most notable of these was the 39-year prison sentence given to David Kwiatkowski, the former New Hampshire hospital technician who caused dozens of people to become infected with hepatitis C when he injected himself with pain killers using syringes that were then used on patients. Kwiatkowski admitted in August to stealing the drugs and leaving used syringes for hospital use for years, despite knowing he was infected with hepatitis C. His case drew national attention to the problem of prescription drug diversion among healthcare workers; caused a number of institutions to finally take a fresh look at their human resource policies and systems being used to detect diversion; and, has, we hope, sent a strong message of deterrence to all healthcare drug diverters — it is only a matter of time before you get caught!

Efforts by national medical organizations (NMOs)

On an extremely positive note, we are beginning to see NMOs join the fight to help stem the opioid epidemic. On Dec. 10, 2013, the American College of Physicians released a position paper titled “Prescription Drug Abuse: A Policy Position Paper From the American College of Physicians.” The goal of the paper was to provide physicians and policy-makers with 10 recommendations to address the significant human and financial costs related to prescription drug abuse. The recommendations include support for additional education, a national prescription drug monitoring program, establishment of evidence-based nonbinding guidelines regarding recommended maximum dosage and duration of therapy, consideration of patient-provider treatment agreements and the passage of legislation by all 50 states permitting electronic prescription for controlled substances.

In turn, in January 2014, the American Academy of Pediatrics (AAP) Committee on Drugs and Section on Anesthesiology and Pain Medicine issued a report titled “Recognition and Management of Iatrogenically Induced Opioid Dependence and Withdrawal in Children.” The clinical report recommended guidelines for prescribers to follow when weaning children from opioids. As noted by lead author Jeffrey Galinkin, MD, “[t]he key reason the AAP was keen to publish this paper and go forward with this guideline is that people are unaware that patients can get drug-specific withdrawal symptoms from opioids as early as five days to a week after having been on an opioid chronically.”

This recommendation was immediately followed by the Centers for Medicare and Medicaid Services (CMS) Jan. 10, 2014, Federal Register Volume 79, Number 7 publication of proposed rules revising the Medicare Advantage (MA) regulations and prescription drug benefit program (Part D) regulations to help combat fraud and abuse in these programs. The proposed rules include requiring prescribers of Part D drugs to enroll in Medicare, a feature that CMS believes will help ensure that Part D drugs are prescribed only by qualified individuals. As reported by Medscape Medical News, CMS is also seeking the authority to revoke a physician’s or eligible professional’s Medicare enrollment if:

• CMS determines that he or she has a pattern or practice of prescribing Part D drugs that is abusive and represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements; or

• His or her Drug Enforcement Administration certificate of registration is suspended or revoked; or

• The applicable licensing or administrative body for any state in which a physician or eligible professional practices has suspended or revoked the physician or eligible professional’s ability to prescribe drugs.

Furthermore, CMS proposes employing data analysis to identify prescribers and pharmacies that may be engaged in fraudulent or abusive activities. In Table 14 of Federal Register Volume 79, Number 7, CMS’ Office of the Actuary estimates the savings to the federal government from implementing its proposed provisions will be $83 million in calendar year 2015, $132 million in 2016, $171 million in 2017, $364 million in 2018 and $589 million in 2019.

Source: CMS

Innovation in our future

In addition to the above efforts, companies continue to innovate and research new ways to address historical challenges.

Vatex Explorations is building a real-time individual-dose monitoring system called Divert-X to reduce drug trafficking, misuse and addictions that result from routine medical care. Divert-X monitors a patient’s individual doses through the electronic transmission of data identifying the time of dose access, location and other measures. The analysis of the data in real time helps physicians and pharmacists identify drug-taking behaviors that fall outside of norms, allowing early intervention before misuse or addiction set in.

In 2012, the Food and Drug Administration approved an ingestible sensor that can be used to track real time data about your pill consumptions habits. The sensor, developed by Proteus Digital Health, was first approved for use in Europe before coming to the U.S. The ingestible sensor is part of the digital health feedback system, which includes a wearable sensor and secure app and is largely focused on serving the transplant population and patients with chronic illnesses. The authors could envision a day when the system could help in the battle against opioid addiction.

Insurance companies are doing a better job of leveraging advanced analytics to understand their opioid-exposed population and the prescribing habits of the physicians treating their injured workers. Through the review of medical bills (e.g., date and types of service and payment, ICD-9 diagnosis codes, CPT-4 procedure codes, etc.) and pharmacy data (e.g., bill frequency,  aggressive refills, NDC drug codes, quantity used, generic vs. brand, supply days, use of prescriber, pharmacy name, etc.), insurance companies can identify usage and treatment patterns that fall outside of expectations using cluster analyses, association rules, anomaly detection and network “link” analyses.

Law enforcement continues to push the envelope in finding innovative ways to combat drug diversion. Take, for example, the strategy developed in consultation with the National Association of Drug Diversion Investigators and Oklahoma Bureau of Narcotics to curb false reporting of the loss or theft of prescription drugs in Stillwater. According to a police spokesman, most physicians in Stillwater require patients to obtain a police report before they will write a replacement prescription for lost or stolen medications. This requirement resulted in an increase in the number of police reports filed, but a new problem emerged. How could anyone determine whether those police reports were legitimate? In response, the Stillwater police department created a database to record the names of any individual who reported the loss or theft of a prescription drug. The department now requires the individual to take a polygraph test before it will accept any subsequent report of a lost or stolen prescription drug. Fail that polygraph, and criminal prosecution may follow. Query: If this strategy were employed nationwide, would the medicine cabinet at home be guarded more closely?

Conclusion

There is no doubt we have come a long way in the battle against opioid addiction in a relatively short time. Although there is a lot of road left to travel, 2014 is well-positioned to carry forward the effective efforts from last year. Given the innovative spirit of the U.S. and passion of everyone involved in winning this fight, a better long-term solution could be just around the corner.