Tag Archives: Center for Disease Control

Legislative Preview for Work Comp in 2016

Common wisdom suggests that major workers’ compensation legislative activity won’t take place during an election year. For 2016, that would seem to hold true.

That is not to say, however, that various interested parties will be sitting idly by, waiting for the clock to turn to 2017.

CENTERS FOR DISEASE CONTROL ADD TO THE LIST OF CHRONIC PAIN GUIDELINES

On Jan. 13, the Centers for Disease Control and Prevention (CDC) closed the public comment period for its proposed Guideline for Prescribing Opioids for Chronic Pain. According to the CDC, the guideline is being proposed to offer “… clarity on recommendations based on the most recent scientific evidence, informed by expert opinion, with stakeholder and constituent input considered.”

The guideline goes to great lengths to address two important issues. The first is that current guidelines in many states – both public and private – are based on dated information. The second, which is critical, adds to the growing number of voices to say that best practices for providers include accessing physician drug monitoring programs (PDMP) to reduce the risk of doctor shopping and toxic – and sometimes fatal – mixtures of prescription drugs when the patient provides incomplete histories or none at all of their drug use (both prescription and illicit).

This need to access a PDMP before, and during, treatment with opioids is echoed by the Medical Board of California (MBC) and the DWC. Their comments also underscore a considerable problem facing California policymakers when trying to create incentives for providers to use the Controlled Substance Utilization Review and Evaluation System (CURES) without directly mandating access.

This dilemma is best summed up by the analysis of Senate Bill 482 by Sen. Ricardo Lara (D – Bell Gardens) that is at the Assembly Desk pending referral to committee. The bill, which would mandate participation in the CURES system as well as other measures to curb the abuse of opioids, has garnered opposition from medical associations and one medical malpractice insurer. The opposition, according to analyses by legislative staff, is based on two issues – the first being whether the CURES system is capable of handling the volume of inquiries a mandate would engender, and the second being concern that requiring CURES access will become a standard of care that could subject providers to malpractice liability.

As to the former, this issue arose during the campaign waged against the 2014 ballot measure Proposition 46. According to the non-partisan Legislative Analyst’s Office (LAO), “Currently, CURES does not have sufficient capacity to handle the higher level of use that is expected to occur when providers are required to register beginning in 2016.” This raises an important question – does the CURES system now have the capability to meet the demand that a mandate would create? If it doesn’t, then the legislature needs to understand why.

As to the second issue, it is difficult to comprehend the level of distrust that is subsumed in the position that opposing a mandatory review of possible prescription drug abuse by a patient would establish more potential malpractice liability than knowing that the CURES database exists and not checking it. In time, perhaps, it will be the appellate courts that resolve that issue.

There is no shortage of guidelines that address the appropriate use and cessation of use of opioids for non-cancer chronic pain. The DWC is finalizing its latest iteration on this issue as part of the MTUS. It will differ from both the CDC and the MBC guidelines to some degree, but the overall treatment of this issue is very similar. In addition, the division will be implementing a prescription drug formulary as required by Assembly Bill 1124 by former Assembly member Henry Perea (D – Fresno). That, too, will likely provide opportunities to address the proper use of opioids in the workers’ compensation context, preferably after the chronic pain guidelines are completed.

As noted by the CDC and the MBC, and implicit in the DWC’s guidelines, this is not just a question of UR. If all the work by the division is simply viewed as a more effective way of saying “no” regardless of the circumstances, then the public health issues associated with the abuses of opioids will continue.

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Progress on Opioids — but Now Heroin?

You’ve probably noticed recent reports, within the workers’ comp pharmacy benefits manager (PBM) industry and elsewhere, that prescription opioid use and overdoses are on the decline. It is a long journey, and we cannot yet see the destination, but progress is being made. One of the goals has been to make it more difficult to secure clinically inappropriate prescription opioids through legitimate (physician, dentist) and illegitimate (pill mills, street sales) means. Abuse deterrent formulations have also helped, creating a hassle factor for those who want to abuse them. The increase in focus on the subject in the media and government has made it more top-of-mind. Although even one death or the creation of one addict is too many, and we have lots of cleanup to do today on the damage already done to individuals and communities, the trends are heartening.

However, for every intended consequence, there are also unpredictable unintended consequences. And one of those that I’ve been following for some time, that two recent clinical studies have codified as accurate, is the dramatic increase in the abuse and misuse of heroin. A good amount of that increase is theorized to be coming from those who may have become addicted or highly dependent upon the euphoric effect or dulling of the pain from opioids. Because today’s heroin is “pharma quality” and less expensive than opioids on the street, heroin has become the primary alternative choice. If you think this is a recent issue, this USA Today article titled “OxyContin a gateway to heroin for upper-income addicts” was my initial warning, on June 28, 2013.

The reasons for this switch are multiple and complicated. An excellent article on this issue was published in the June 2015 edition of “Pain Medicine News.”

Three quotes that struck me the most:

  • “Fewer than 20% of chronic pain patients benefit from opioids.”
  • “The prolific normalization of opioid use for chronic pain within primary care has seeded the epidemic of heroin addiction.”
  • “We are going to see the biggest explosion of heroin addiction ever in the next five years.”

Obviously, heroin is an illegal drug and therefore cannot be tracked or managed within a PBM. But everyone needs to be watching. While heroin use may not be a “workers’ comp problem,” it is a societal problem, which ultimately always rebounds as an issue for everyone (and everything) else.

The CDC just published (or at least publicized on Twitter) a “Vital Signs” report specifically on the subject. This should be required reading for everyone concerned with the epidemic of substance abuse in the U.S. Note that I said “substance abuse,” because as has been clearly stated the issue is not specific to prescription drugs or heroin or cocaine or alcohol binge drinking — it is a cultural issue of people either wanting to have a good time or just to check out from life or pain. According to this CDC report, more than 8,200 people died from heroin overdoses in 2013. When you add that to the more than 175,000 people who have died from prescription drug overdoses since 1999, the people affected is staggering. Not just those who lost their lives, but friends and family left behind and communities (and, in some cases, employers) dealing with the aftermath.

While there is a treasure trove of information included in the CDC’s report, the most important point for me (given my focus since 2003) was the advice to states:

  • Address the strongest risk factor for heroin addiction: addiction to prescription opioid painkillers

If you still don’t believe that opioid use and the abuse of heroin (and other drugs) are related, you just aren’t paying attention. Or you don’t want to connect the dots. I will let the CDC prove my point …

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The use of heroin is no respecter of income level, age, gender, education or geographic location. However, the CDC did outline those most at risk for use:

  • People who are addicted to prescription opioid painkillers
  • People who are addicted to cocaine
  • People without insurance or enrolled in Medicaid
  • Non-Hispanic whites
  • Males
  • People who are addicted to marijuana and alcohol
  • People living in a large metropolitan area
  • 18- to 25-year-olds

Do yourself a favor. Take 10 minutes and read the report from the CDC. It will only be wasted time if the information does not influence you to action.

The Thorny Issues in a Product Recall

In 1982, people in Chicago began dropping dead from cyanide poisoning, which was linked to Johnson & Johnson’s Tylenol in select drug stores. Johnson & Johnson immediately pulled all Tylenol from the shelves of all stores, not just those in Chicago. It was ultimately determined that the product had been tampered with by someone outside of Johnson & Johnson. But the company’s aggressive actions produced a legend: The Tylenol scare was chalked up as the case to review for an effective brand-preserving (even brand-enhancing) product recall strategy.

In 2011, though, the FDA took the extraordinary step of taking over three Johnson & Johnson plants that produced Tylenol because of significant problems with contamination. This time, Johnson & Johnson could not blame a crazed killer, only itself. A company that should have learned from its own celebrated case study had not retained that knowledge 30 years later.

The problems associated with recalls often aren’t the recall itself. In a recall, stores pull the products, and the media helps get the message to those who have already purchased the product to return them for refunds, replacement, repair or destruction.

One problem crops up when companies are too slow to move. It was revealed in the press in June 2014, that GM allegedly knew of its ignition switch problems seven years before it recalled the product. The recall that began in February 2014 itself became tortuous as new models were added almost daily to the list of cars that were in danger of electrical shutdown while in motion. The press, the regulators and, of course, the lawyers pounced on GM for its alleged withholding of information for so long and for the seemingly endless additional recall of cars affected by the problem. In 2015, regulators have called meetings with GM and other auto manufacturers mired in what has become an epidemic of recalls to discuss why repairs are dragging on so long.

Denial, lack of information, hunkering down (bunker mentality), secrecy, silo mentality and fears for the impact on the bottom line all contribute to disastrous recalls. With all recalls, there is the cost of the recall, the cost of complete or partial loss or loss of use of certain products, repair costs in some cases (GM), regulatory scrutiny and fines, class action and other lawsuits and the loss of potential income during any shutdown. These can all be big-ticket items, and some companies will not survive these expenses and loss of revenue.

Probably the biggest cost of any recall is the cost to reputation, which can mean loss of existing and future customers. In recent years, lettuce growers and a peanut warehouse did not survive recalls over contaminated products. In the case of primary agricultural producers like growers and peanut warehouses, the processors simply change suppliers, leaving the primary producers without any customers. In the retail market, the competition for shelf space is high. Brands that are recalled that are new or that do not have high customer value are simply barred from shelf space, effectively destroying the ability to market their products.

However, there are others that have strong brand following and even cult-like status in local markets. Blue Bell Creameries (famous for its ice cream) is one such company that has secured an almost cult-like following in the Southern and Midwestern states. Blue Bell, founded in 1907, maintains its headquarters in the small town of Brenham, TX (pop. 16,000).

Problems began when hospitals in Arizona, Kansas, Oklahoma and Texas reported patients suffering from an outbreak of listeria-related diseases, some as early as 2010. Some reports included the deaths of patients. On May 7, the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) reported, “It wasn’t until April 2015 that the South Carolina Department of Health and Environmental Control during routine product sampling at a South Carolina distribution center, on Feb. 12, 2015, discovered that a new listeria outbreak had a common source, Blue Bell Chocolate Chip Country Cookie Sandwich and the Great Divide Bar manufactured in Brenham Texas.”

Listeria is a bacteria that can cause fever and bowel-related discomfort and even more significant symptoms, especially in the young and elderly. Listeria can kill. Listeria is found naturally in both soil and water. Listeria can grow in raw and processed foods, including dairy, meat, poultry, fish and some vegetables. It can remain on processing equipment and on restaurant kitchen equipment, and when food comes in contact with contaminated equipment the bacteria finds a ready-made food source in that food and multiples. The FDA has issued guidance reports to food processors, preparers and restaurants on how to prevent listeria contamination. This includes proper preparation techniques, cleaning techniques, hygiene, testing and manufacturing and processing methodologies.

Once Blue Bell understood that its cookie sandwiches and ice cream bars were implicated, the company immediately recalled the products. But soon it became evident to Blue Bell and others that this outbreak might not be limited to the ice cream bars or cookie sandwiches, and Blue Bell recalled all of its product and, to its credit, shut down all manufacturing operations.

The FDA conducted inspections of Blue Bell plants, and in late April and early May produced reports on three plants, noting issues of cleanliness and process that were conducive to listeria growth. The FDA has also reported that Blue Bell allegedly had found listeria in its plants as far back as 2010 but never reported this to the FDA.

As of this writing, Blue Bell plants are still shut down. The FDA investigation has come to a close, but many questions remain. The company has cut 1,450 jobs, or more than a third of its work force, and has said it will reenter the market only gradually, after it has proved it can product the ice cream safely.

The question is whether these things Blue Bell has done: the quick recall, first of the problem products and then all products, and the closure of plants to mitigate contamination issues are enough to save Blue Bell from further damage in the eyes of consumers and the stores that sell the product. There are many tough questions to be answered going forward.

In the intervening months, will competitors replace Blue Bell with their own products that consumers feel will compare favorably? If so, when Blue Bell products are returned to stores will consumers return, or has the stigma of listeria and the acceptance of the taste of comparable products weakened the brand? Will stores give Blue Bell adequate shelf space? And, does Blue Bell have enough of a cult following and viral fan base that once product is back in stores customers will return as if nothing had happened? These are the scary questions that affect all food and drug companies when recalls are from contamination in their own plants or those in their supply chain.

The American consumer seems to have become numb to the endless succession of automobile recalls from just about all manufacturers. We dutifully return our vehicles to the dealer to fix a broken or faulty this or that. Even though many recalls involve parts or processes that could cause car accidents, injuries and deaths, it is as if we have come to accept faulty auto products as the norm.

This is not the case with food-borne illnesses. The fact that a faulty car can kill as easily as a contaminated food product seems not to be an issue as people return again and again to buy new cars from the same car manufacturer that issued five recalls on their last purchased model. However, consumers will shun the food brand that made some people ill. This bifurcated approach to risk makes no sense even in the context of protecting children from harm. The faulty car that mom drives the kids around in every day may have the same probability of injuring or killing her child as the recalled food brand. She doesn’t abandon her car, but she bans the recalled food brand from her table.

In 1990, Perrier discovered benzene in its sparkling water product. It quickly recalled all its product but then hunkered down into a bunker mentality. The lack of communication by Perrier about the problem and what it was doing exacerbated the fears of consumers, and the press speculation and outcry ran high. Perrier had always touted the purity of its water, so toxic benzene shattered this claim. Hunkering down reduced consumer confidence, and many left Perrier for suitable alternative products. Perrier has never regained the market share it had previously.

Blue Bell has taken the time to do things right, to find the causes of the problem and take steps necessary to prevent contamination in the future. But time also means that existing or even new competitors with comparative products will try to fill the shelf space vacated by Blue Bell’s absence. You can be sure that other-region favorites with cult followings that could never before gain a foothold in Blue Bell’s territory have been pressuring retailers to try them out as a replacement for Blue Bell.

Is the Perrier loss of market share inevitable for Blue Bell even if Blue Bell communicates adequately and with transparency? Time will tell. For now, Blue Bell not only has to fix the problems of plant cleanliness, it also needs to address emerging questions about its past operations, such as allegedly not reporting to the appropriate

While we note the good press that surrounded the 1982 Tylenol (external-tampering) recall and have seen so far a good effort by Blue Bell to resolve its own plant contamination issue, ultimately it is contamination that is the problem. Companies can become complacent, let cleanliness slide, use outmoded procedures, not replace older equipment or even ignore warning signs and isolated contamination events. Regional and limited product line companies need to be especially cognizant that even though they have carved out a powerful niche in the marketplace, maintaining this niche is tenuous at best in the highly competitive world of food products. Cleanliness and contamination-free are assumed by consumers. Food processors and manufacturers must do everything possible to keep that assumption from becoming contradicted.

Next Tsunami of Work Comp Payments

2009 was a milestone in workers’ comp. In that year, the Centers for Medicare and Medicaid Services (CMS) formally announced that it would review future prescription drug treatment in Workers’ Compensation Medicare Set-Aside (WCMSA) proposals based on “appropriate medical treatment as defined by the treating physician.” While the U.S. culture and Centers for Disease Control and Prevention (CDC) had already noticed the prescription drug epidemic, this new requirement more clearly highlighted high-cost drug regimens that were doing more clinical harm than good.

Yes, the monthly drug costs were already known to be expensive. Yes, reserves often had to be raised annually. But until the workers’ comp industry had to follow explicit rules to calculate the lifetime cost associated with continued inappropriate polypharmacy regimens, the problems hadn’t really registered.

The new requirement dramatically changed the ability to settle and close a claim, so addressing the overuse and misuse of prescription drugs, primarily related to non-malignant chronic pain, became a white hot priority. The financial exposure highlighted by the WCMSA was a tsunami that changed the contours of the claims shoreline.

Well, another milestone has been achieved for workers’ comp. I have been talking about it, as well, over the past three years, because I could see the riptide indicators of the next tsunami to hit. And now the surge is about to hit the shore.

This next workers’ comp tsunami? Death benefits that will be paid because of drug overdoses.

This has already been affirmed in a handful of states, among them Pennsylvania (James Heffernan), Tennessee (Charles Kilburn) and Washington (Brian Shirley). Death benefits have been denied in other states, including Connecticut (Anthony Sapko) and Ohio (John Parker). I’m sure this is not a complete list. The list shows how individual circumstances and jurisdictional rules can drive different decisions, but what is not up for debate is whether payers face an issue concerning injured workers dying from an overdose (intentional or unintentional) of prescription drugs paid for by workers’ comp.

The game-changer could be a new decision in California, South Coast Framing v. WCAB. The full Supreme Court decision can be found here, and a good article that gives additional context can be found on WorkCompCentral (requires a subscription).

To summarize, Brandon Clark died on July 20, 2009. The autopsy reported his death “is best attributed to the combined toxic effects of the four sedating drugs detected in his blood with associated early pneumonia.” Elavil, Neurontin and Vicodin were being prescribed by his workers’ comp physician, while Xanax and Ambien were prescribed by his personal doctor. Of that list, the four sedating drugs are Elavil, Vicodin, Xanax and Ambien — obviously a mixture of workers’ comp and “personal” drugs.

The qualified medical evaluator (QME) doctor ascribed the overdose to the additive effect of Xanax and Ambien and not the workers’ comp drugs. However, he allowed that Elavil and Vicodin could have contributed (the deposition quotes on pages three and four remind me of a Monty Python skit, as he tried inartfully to not provide apportionment). So … what is the strength of causality between the industrial injury and death? Tort is much more precise in its understanding — cause, in fact, and proximate cause. Workers’ comp (which is no-fault) is not tort, and neither is its definition of causality — contributing cause of the injury.

Did Clark misuse or overuse the drugs through willful misconduct? Possibly. Should one of his physicians have recognized the additive sedative effects from the combination of drugs and done something different? Probably. Was Clark trying to address continued legitimate pain that originated with his workplace injury? Likely. Is this a tragedy? Definitely.

So the decision came down to whether the workers’ comp drugs (Elavil and Vicodin) could have been part of why Clark died.

The Court of Appeal concluded that Elavil only “played a role” and was not a “significant” or “material factor.” The Supreme Court found the evidence to be substantial that Elavil and Vicodin, to some degree, contributed to his death. Therefore, they awarded death benefits to Clark’s wife and three children.

What does this mean? At least in California, it means that the bar of establishing causality (did workers’ comp drugs somehow contribute) is not as high as you might have expected. There is no further debate because this is a Supreme Court decision. Does that mean more death benefits are to come in California? In a highly litigious state where representation is commonplace. And prescription drug use for chronic pain is an overwhelming problem. Hmmm …. My “magic eight ball” is in for maintenance, but my educated guess (I am not an attorney) would be yes.

What about other states? Well, every state has different rules and case history, but because trends often start in California, and the Supreme Court was articulate in its decision-making process, it’s possible this causes a re-examination by all parties. The fact that some states already have established case law to grant death benefits could be a compounding effect. Therefore, it’s a definite maybe.

This may be an isolated case that has no repercussions in California or elsewhere. On the other hand … Consider this your RED FLAG warning for the riptide that precedes the tsunami. And you thought paying for drugs was expensive!

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.