Thursday, March 28, 2019

Mississippi Man Pleads Guilty to Health Care Fraud, Money Laundering and Tax Evasion Charges for Role in $200 Million Compounding Pharmacy Scheme

 
 
 
There is an old expression that says, “You can’t outrun the long arm of the law” and when it comes to healthcare, truer words were never spoken.  The federal government keeps a close eye on anyone involved in the field whether it be clinically or behind the scenes, if they are able to bill the feds for services, materials, etc.
Unfortunately those who can bill the federal government for anything in the healthcare realm often try and turn this into a profit center by over billing, over charging, coding for procedures not done, or products not used/delivered.  Often news stories pop up with information on some type of healthcare provider who overfills the tune of millions of dollars & expects never to get caught.
Well, here’s another example of why it’s just better to do the right thing in the first place.  Read this amazing announcement courtesy of the US Department of Justice:
 
Mississippi Man Pleads Guilty to Health Care Fraud, Money Laundering and Tax Evasion Charges for Role in $200 Million Compounding Pharmacy Scheme
 

A Hattiesburg, Mississippi man pleaded guilty today for his role in a $200 million compounding pharmacy scheme to defraud health care benefit programs, including TRICARE, which is the program that covers U.S. military service members and their families.

 

Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division; U.S. Attorney Mike Hurst of the Southern District of Mississippi; Special Agent in Charge Christopher Freeze of the FBI’s Jackson, Mississippi Field Office; Special Agent in Charge Thomas J. Holloman III of IRS Criminal Investigation’s (IRS-CI) Atlanta Field Office and Special Agent in Charge John F. Khin of the Defense Criminal Investigative Service’s (DCIS) Southeast Field Office made the announcement.

 

Glenn Doyle Beach Jr., 46, pleaded guilty to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering and tax evasion, before U.S. District Judge Keith Starrett of the Southern District of Mississippi.  Beach was charged in May 2018 in a 26-count indictment and had been scheduled to begin trial today.  He is scheduled to be sentenced on July 2, 2019.

 

“Glenn Doyle Beach and his co-conspirators stole hundreds of millions of dollars from federal health care programs, including TRICARE, which provides benefits to brave members of our military and their families,” said Assistant Attorney General Benczkowski.  “The Criminal Division remains dedicated to rooting out and punishing this kind of misconduct, and to protecting America’s important health care programs from fraud and abuse.”

 

“While our men and women in uniform were defending the freedoms and values we hold dear, this defendant was selfishly stealing precious money and resources from their military healthcare system, TRICARE, to the detriment of us all,” said U.S. Attorney Hurst.  “Our investigators and prosecutors are to be commended for their steely resolve in rooting out corruption and administering justice for victims.  We will not stop until every last person involved in this criminal scheme has been brought to justice.”

 

“Fraud schemes of this magnitude disrupt the fabric of our health care system, ultimately damaging our nation's economy and costing taxpayers billions each year,” said FBI Special Agent in Charge Freeze.  “Today's guilty plea brings this case one step closer to justice and proves that the collective resources of all partnering agencies will continue to expose these schemes and will actively seek justice for those who participate in them."

 

Beach was an owner and the managing member of Advantage Pharmacy of Hattiesburg.  At the hearing today, Beach admitted his role in a scheme to defraud health care benefit programs, including TRICARE, by marketing medications known as compounded medications, which ordinarily are medications that are specially combined or formulated to meet the individual needs of patients.  Beach admitted, however, that through Advantage Pharmacy of Hattiesburg, he formulated compounded medications without regard to the individual needs of the patients, but instead in order to increase reimbursements paid by health care benefit programs.  Furthermore, Beach admittedly created a fictitious paper trail to mislead insurance auditors who attempted to uncover the fraud.

 

Beach further detailed a money laundering and tax evasion scheme that he and other co-conspirators used to conceal the fraudulent proceeds and evade taxes.

 

From approximately April 2012 through January 2016, health care benefit programs, including TRICARE, reimbursed Advantage Pharmacy and other pharmacies involved in the scheme at least $200 million, Beach admitted.  The government seized more than $6 million in cash and other assets from Beach, which will be forfeited in connection with his guilty plea.

 

Since 2017, 11 other individuals involved in this scheme have pleaded guilty, and one was convicted at trial.  The investigation is ongoing.

 

This case was investigated by the FBI, IRS-CI and DCIS, among other agencies.  Trial Attorneys Kate Payerle and Jared Hasten of the Criminal Division’s Fraud Section and Assistant U.S. Attorneys Mary Helen Wall of the Southern District of Mississippi and Sean Welsh of the Western District of Virginia, formerly of the Criminal Division’s Money Laundering and Asset Recovery Section (MLARS), are prosecuting the case, with the assistance of Trial Attorney Amanda Wick of MLARS.

 

The Fraud Section leads the Medicare Fraud Strike Force, which is part of a joint initiative between the Department of Justice and U.S. Department of Health and Human Services (HHS) to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.  Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 14 strike forces operating in 23 districts, has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $14 billion.  In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.

Wednesday, March 27, 2019

Duke Pays $112.5 Million Settlement for Research Fraud - Why You Cannot Believe Every Piece of Research You Read

 
 
 
 
 
It’s easy to believe things you see in print.  It’s even easier to believe something written & endorsed by a major educational institution.  One of the principle concepts behind science is a healthy dose of skepticism.  This is twofold.  Number one is that you cannot go into research thinking you know the answers, that can taint your interpretations.  Hence the whole concept of double blinding experiments. Number two is that when reviewing the data, it must be viewed empirically & not just believed straight away.
That’s because there are always factors that you may be unaware of when reading a study and mentally digesting the data.  One of the biggest mistakes we can make is to just blatantly assume that because a study was done at a well known and respected institution that it is guaranteed to be correct.  Something many don’t realize is that research is a big money maker for universities.  Most research is funded by grants or paid for my companies wishing to have favorable data published about their product(s).  Because of that, before the study is even started the money can very well influence the study design and, once completed, it can affect what data is left in or left out.  When a company is spending huge amounts of money for good results, the pressure to create those good results can affect things more than many people realize.
Today, news is breaking that Duke, a well respected institution, is paying $112.5 million in restitution for fraud related to research that one individual created.
Here is the story from the Duke Today:

Duke University will pay $112.5 million to the United States Government to settle Thomas v. Duke, a lawsuit alleging that a research technician improperly falsified and fabricated data from 2006 to 2013 to obtain research funding from the National Institutes of Health (NIH) and other federal agencies, the university announced Monday.

 

Duke discovered the possible research misconduct in 2013 after the technician was fired for embezzling money from the university, which also occurred over the same period.  The payment to the government includes both reimbursement for grants received as a result of the falsified and fabricated data and associated penalties.

 

The Thomas v. Duke suit was filed by a former Duke employee under the False Claims Act, a federal law that allows people not affiliated with the government to file actions on behalf of the government against persons and companies that defraud the government.  Persons filing under the act can receive a portion of damages.

 

“We expect Duke researchers to adhere always to the highest standards of integrity, and virtually all of them do that with great dedication,” said President Vincent E. Price. “When individuals fail to uphold those standards, and those who are aware of possible wrongdoing fail to report it, as happened in this case, we must accept responsibility, acknowledge that our processes for identifying and preventing misconduct did not work, and take steps to improve.”

 

Thomas v. Duke was filed under seal in federal court in 2014 -- after the research technician was discovered to have embezzled federal grant funds that had been awarded to the university, but before Duke understood the extent of her research misconduct.  Duke reported this to the appropriate agencies and repaid the embezzled funds along with all grant-funded compensation and benefits that had been paid to the technician. The technician eventually pled guilty to two counts of forgery and paid restitution to Duke.

 

The university then launched a formal scientific misconduct investigation of the technician’s experiments. Those experiments involved measuring the lung function of laboratory mice using highly specialized equipment and were not connected to human subject or clinical research.

 

Following a detailed, three-year review of more than 50 potentially compromised research grants, Duke concluded that the technician had falsified or fabricated data that had been included in grant and payment requests submitted to the NIH and other agencies over the period of her employment.  Duke also retracted scientific publications that relied on the data.

 

In response to the settlement, Duke immediately will implement a series of key steps to build on the university’s already wide-ranging efforts to improve the quality and integrity of research conducted on campus, including:

 

  • The appointment of a new Advisory Panel on Research Integrity and Excellence chaired by Ann M. Arvin, professor of pediatrics and microbiology and former vice provost and dean of research at Stanford University, and including Edward M. Stolper, William E. Leonhard Professor of Geology and former provost of Caltech, and Barry S. Coller, David Rockefeller Professor, physician in chief and vice president for medical affairs at Rockefeller University.  The advisory panel will provide recommendations to President Price and university leadership for improving the structure and function of research administration, with a focus on promoting research integrity, by June 30, 2019;
  • The establishment of a new, integrated leadership structure for research to provide clear and consistent policy guidance, oversight and accountability for all research at Duke University and Duke Health;
  • A new initiative to promote values and a culture of excellence and accountability at Duke;
  • The creation of an Executive Oversight Committee, chaired by Chancellor for Health Affairs A. Eugene Washington and including senior leadership and faculty, and a related Faculty Advisory Committee to oversee the ongoing implementation of Duke’s research excellence initiative.

These steps build on significant work already completed to improve research integrity at Duke over the past decade.

 

Even before the Thomas v. Duke case came to light, the university significantly expanded its research education, training, oversight and accountability efforts. These improvements, including, some informed by this case, include:

 

  • Required science and accountability plans for all School of Medicine units;
  • Mandatory Responsible Conduct of Research training for all School of Medicine faculty and staff involved in research, with campus-wide implementation underway, as well as town hall meetings on relevant research integrity topics;
  • The appointment of Geeta Swamy as associate vice provost and vice dean for scientific integrity.  Swamy leads the Office of Scientific Integrity, which includes the Advancing Scientific Integrity, Services and Training (ASIST) initiative, and oversees conflicts of interest, research misconduct, a new institutional research incident response team and the Clinical Quality Management Program;
  • Significant improvements in clinical research oversight, including the establishment of clinical research units, and creation of the Duke Office of Clinical Research and the Duke Translational Medicine Quality Framework;
  • Continued implementation of the Research Administration Continuous Improvement initiative.

“Through these efforts, many of which have been underway for several years, we aim to promote and adhere to the highest standards of research excellence and integrity,” Price added.  “We continue to have great confidence in the high quality of Duke faculty and their research. This settlement, which results primarily from willful misconduct that took place in one laboratory, but which affected the work of many more researchers, should not diminish the life-changing and life-saving work that takes place at every day at Duke. Our difficulties in ferreting out and ending such misconduct remind us that important work remains to be done.”

Tuesday, March 26, 2019

Fentanyl Linked Deaths are on the Rise - When Will the Idea of Treatment Instead of a Supply Interdiction Begin to Take Hold

 
 
 
The “opioid crisis” has been an unfortunate event in the recent history of medicine.  However, what has been more tragic than the deaths and destruction it has left in its wake is the ongoing problems that no one seems interested in solving.
 
It seems that everyone in a government position has opted “all in” on stopping the over prescribing of opioids, which is in and of itself a good thing, but what they are failing to take into consideration is the individuals who are caught in the middle of this issue.  Big pharma created a huge number of people who became dependent on opioids through no fault of their own.  These folks are caught in a terrible limbo of being addicted and then being cut off from their supply of medication with no consideration of what will happen to them.
 
Legislators and professional licensing boards have put severe clamps on prescribing which has helped shut down “pill mills” and those unethical practitioners who wrote prescriptions for thousands of pills just to line their own pockets.  However, as the supply of legally available medications has dwindled, caught in the cross fire of those wishing to end the “opioid epidemic” are the individuals who have been left dependent on those medications and unable to get those medications.  Those poor individuals are left to twist in the wind in the horrible throes of withdrawal.
 
It seems to me that the one thing lacking in this whole fight has been a focus, even a remote focus, on the patients who are forced to go on a cold turkey withdrawal.  That is as medically unethical as the over prescribing that created their dependence in the first place.  Instead the focus of those who want to solve the problem has been on decreasing the supply.
 
Unfortunately, be decreasing the supply and access to these drugs, the problems “fixers” have created an entire population that has 2 choices, suffer the indescribable tortures of withdrawal or find another source of drugs that keeps the withdrawal at bay.  Since no one in power has seen fit to be concerned about helping these people by providing detox treatment, many of these sufferers have taken it upon themselves to seek drugs on the street.
 
Now we are seeing a new crisis in development, deaths due to overdose of drugs obtained through illegal sources.  If those in power truly want to end the drug problems in the US, they have to focus on treating the individual who are afflicted with this disease and/or dependence.  Trying to limit the supply simply doesn’t work.  We’ve been fighting a “war on drugs” since the Nixon administration and despite the hundreds of billions of dollars spent on interdiction, the problem continues.  The focus needs to change to treatment and not supply stifling or jail time.
 
The CDC has released an article that discusses the increase in deaths due to street Fentanyl purchased by those abandoned in the “war on drugs” and left to fend for themselves.  Trying to limit the supply will just force people to seek relief illegally and that is by far much more dangerous.  Read on for CDC's take.  If you would like access to the entire study, complete with graphs and references, it can be read on the CDC website in pdf
 
Abstract Objectives—Fentanyl, a synthetic opioid, has been increasingly identified in drug overdose deaths. This report describes trends in drug overdose deaths involving fentanyl by demographic characteristics and geographic regions from 2011 through 2016.
 
Methods—Drug overdose deaths were identified from the National Vital Statistics System—Mortality (NVSS–M) multiple cause-of-death files (2011–2016) using International Classification of Diseases, 10th Revision underlying causes of death (codes X40–X44, X60–X64, X85, or Y10–Y14). NVSS–M records for drug overdose deaths were linked with literal text from death certificates. Drug overdose deaths involving fentanyl were identified using a methodology established collaboratively by the National Center for Health Statistics and U.S. Food and Drug Administration—referred to as the Drugs Mentioned with Involvement (DMI) methodology—supplemented with search terms identified using text analytics software. Fentanyl involvement was determined by the presence of any string term or phrase listing fentanyl, or any fentanyl metabolite, precursor, analog, or misspelling identified in the death certificate literal text fields (i.e., the causes of death from Part I, significant conditions contributing to death from Part II, and a description of how the injury occurred). Trends were evaluated using the National Cancer Institute’s Joinpoint Regression Program.
 
Results—The number of drug overdose deaths involving fentanyl was stable in 2011 (1,663) and 2012 (1,615), and began to increase in 2013, rising to 18,335 deaths in 2016. The ageadjusted rate increased from 0.5 per 100,000 standard population in 2011 to 5.9 per 100,000 in 2016, with the increase starting in 2013 (0.6 in 2013 to 1.3 in 2014 and 2.6 in 2015). Numbers and rates increased for all sex, age, and racial and ethnic subgroups, and most public health regions. Adjustment for improved drug reporting over the study period did not change the trend patterns observed. Conclusions—This report illustrates the rise in drug overdose deaths involving fentanyl from 2011 through 2016 nationally, and by age, sex, race and ethnicity, and public health region. Understanding national trends and patterns for drug overdose deaths involving fentanyl may inform public health policies and practices. Keywords: National Vital Statistics System • national trends • mortality • death certificate literal text
 
Introduction
Fentanyl is a synthetic opioid that has been involved increasingly in drug overdose deaths (1–11). In 2011 and 2012, fentanyl was involved in roughly 1,600 drug overdose deaths each year, but from 2012 through 2014, the number of drug overdose deaths involving fentanyl more than doubled each year (1). State-based analyses suggest that the recent increase in overdose deaths involving fentanyl may be related to increased availability of illicitly manufactured fentanyl (3,4,9–11). Illicitly manufactured fentanyl includes various analogs (e.g., acetylfentanyl, carfentanil, furanyl fentanyl) that vary in potency and can be lethal in very low concentrations (3). National mortality statistics on drug overdose deaths have traditionally used the International Classification of Diseases, 10th Revision (ICD–10) to classify and monitor drugs involved in deaths (12). However, ICD–10 is limited to broader categories (e.g., synthetic opioids other than methadone) that make it difficult to identify deaths involving specific drugs of interest (e.g., fentanyl or illicitly manufactured fentanyl analogs). The National Center for Health Statistics (NCHS) and the U.S. Food and Drug Administration (FDA) collaboratively developed methods, referred to as the Drugs Mentioned with Involvement (DMI) methodology, to analyze literal text data from death certificates to identify specific drugs involved in deaths (13). A recent study using the DMI methodology found that fentanyl was the ninth most frequently mentioned drug involved in overdose deaths in 2013 and the most frequently mentioned drug in 2016 (2). It also showed that deaths involving fentanyl often involved other drugs. For example, in 2016, nearly 70% of deaths involving fentanyl also involved one or more other drugs, such as heroin or cocaine (2).
 
This report describes the trends in drug overdose deaths involving fentanyl from 2011 through 2016, using mortality data from the National Vital Statistics System linked to literal text information from death certificates. Temporal trends, geographic patterns, and differences among demographic groups are presented.
 
This descriptive study analyzed National Vital Statistics System mortality (NVSS–M) multiple cause-of-death data from 2011 through 2016. NVSS–M contains information extracted from death certificates on cause of death and demographic and geographic factors (14). The study population was limited to U.S. residents. Drug overdose deaths were identified using ICD–10 underlying cause-of-death codes X40–X44, X60–X64, X85, and Y10–Y14. These underlying-cause codes identify the deaths due to acute toxicity from drugs (i.e., drug overdose) rather than to chronic exposure leading to death (e.g., liver toxicity) or adverse effects from therapeutic or prophylactic dosages of drugs. Drug overdose deaths include all intents (i.e., unintentional, suicide, homicide, and undetermined intent). Use of these underlying cause-of-death codes is consistent with other NCHS publications on drug overdose deaths and facilitates comparisons with other analyses using ICD–10-coded data (1,2,15).
 
NVSS–M records for drug overdose deaths were linked to literal text data from death certificates. The literal text is the written information provided by the medical certifier, usually a medical examiner or coroner in the case of drug overdose deaths, that describes the cause of death as well as other factors or circumstances that contributed to the death (16,17). Literal text from three fields of the death certificate—the causes of death from Part I, the other significant conditions contributing to death from Part II, and the description of how the injury occurred—was analyzed to identify the specific drugs involved in the overdose death.
 
Identifying drug overdose deaths involving fentanyl
 
results from an exploratory analysis of the literal text using SAS Contextual Analysis software (18). The DMI methodology (13) searches the literal text fields of NVSS–M data for mentions of drugs and for terms that provide context about involvement of the drug in the death (i.e., whether the drug contributed to the death). Drugs mentioned in the death certificate literal text are assumed to be involved in the death unless contextual information suggests otherwise (13). For example, “METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION” does not suggest drug involvement in mortality, but rather a type of bacterial infection. Similarly, the phrase “NOT DRUG RELATED” clearly indicates that drugs were not involved in the death even though “DRUG” is included in the phrase.
 
To supplement the DMI methodology, SAS Contextual Analysis software (18) was used to identify additional search terms. Linguistic rules were defined to search for new drug misspellings; precursors; metabolites; analogs of fentanyl, including those containing special characters, numbers, and dashes; and to identify forms that may be illicit (e.g., acetylfentanyl, carfentanil) or are brand or prescription forms of fentanyl (e.g., duragesic, sufentanil, remifentanil). The additional search terms identified using the contextual software were incorporated into the DMI methodology and are described in the Technical Notes. With the expanded list of search terms, the total number of drug overdose deaths identified as involving fentanyl was slightly higher than previously reported (7 deaths in 2011, 10 deaths in 2012, 14 deaths in 2013, and 23 deaths in 2014) (1). 
 
Analysis For this report, the label “drug overdose deaths involving fentanyl” includes drug overdose deaths involving fentanyl, whether prescription or illicitly manufactured, as well as deaths involving any fentanyl metabolites, precursors, or analogs as identified in the death certificate literal text (see Technical Notes). The numbers and rates for drug overdoses involving fentanyl were calculated and compared by demographic and geographic region. Bridged-race vintage postcensal resident population estimates were used to calculate death rates (14). Age-adjusted death rates were calculated using the direct method and the 2000 standard U.S. population (14). Unless otherwise noted, rates in the text refer to age-adjusted rates.
Geographic patterns in overdose deaths involving fentanyl are presented by the U.S. Department of Health and Human Services (HHS) 10 public health regions. These regions are used for public health prevention, preparedness, and agency-wide coordination of HHS programs and policies (19). These regions, excluding U.S. territories, are:
 
• Region 1—Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont
• Region 2—New Jersey, New York, New York City
• Region 3—Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia
• Region 4—Alabama, Florida, Georgia, Kentucky, Mississippi, South Carolina, Tennessee
• Region 5—Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin
• Region 6—Arkansas, Louisiana, New Mexico, Oklahoma, Texas
• Region 7—Iowa, Kansas, Missouri, Nebraska
• Region 8—Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming
• Region 9—Arizona, California, Hawaii, Nevada
• Region 10—Alaska, Idaho, Oregon, Washington
 
Trends in rates for drug overdose deaths involving fentanyl were evaluated using the National Cancer Institute’s Joinpoint Regression Program Version 4.6.0.0 (20). Joinpoint software fitted weighted least-squares regression models to the rates on the log transform scale. Allowing one observed time point at each end and two for the middle line segments, the Grid Search Algorithm searched for a maximum of two joinpoints at an overall alpha level of p < 0.05 (21). Pairwise comparisons of trend segments among subgroups were also analyzed, with Bonferonni adjustment (20). Rates between subgroups were compared using a z test at the 0.05 level of significance (14). Unless otherwise stated, any mention of an increase in rates indicates a statistically significant change.
 
Assessment for improved reporting on death certificates
 
The ICD–10 multiple-cause codes T36–T50.8 provide information on the types of drugs or drug classes involved in the death. The ICD–10 multiple-cause code T50.9 indicates a nonspecific reference to a drug (e.g., “multidrug,” “polypharmacy,” “drug”). The percentage of deaths with an underlying cause of X40–X44, X60–X64, X85, or Y10–Y14 that had a multiple-cause code of T36–T50.8 is a measure of the specificity of reporting drugs or drug classes in drug overdose deaths. This measure was used to assess possible changes in reporting of specific drugs and drug classes through the years of the study. The percentage of drug overdose deaths coded with T36–T50.8 increased each year (75.0% in 2011, 76.0% in 2012, 77.9% in 2013, 80.7% in 2014, 83.1% in 2015, and 85.4% in 2016) (21,22).
 
To assess the possible impact of lower reporting of specific drugs in the years prior to 2016, an adjustment factor accounting for improved reporting of specific drugs over the time period was applied to each age-adjusted rate for drug overdose deaths involving fentanyl (i.e., by year, sex, age, race and ethnicity, and public health region). The adjustment factor assumed that the specificity of drug reporting had remained constant from 2011 through 2016 at the 2016 drug specificity rate; the adjustment factor was recalculated and applied to each age-adjusted rate for the stratified analyses (i.e., demographic and geographic groups). Results from this analysis show similar trends for both the observed and adjusted values (see Technical Notes). The following results reflect the numbers and rates based on observed values. The number of drug overdose deaths involving any particular drug in any particular year should be considered the minimum number, as there may be additional deaths in which the drug was involved but not specified on the death certificate literal text. All results should be interpreted in light of the improved reporting of specific drugs in the literal text over time.
 
Results
Number and percentage of drug overdose deaths involving fentanyl
 
Annually, the number of drug overdose deaths involving fentanyl was stable in 2011 (1,663) and 2012 (1,615), and began to increase in 2013 (1,919), rising to 18,335 deaths in 2016 (Table 1). From 2013 through 2016, the number of deaths approximately doubled each year. From 2011 through the third quarter of 2013, there were fewer than 500 fentanyl-involved deaths per quarter (Figure 1, Table 1). Beginning in the last quarter of 2013 through 2016, the number of deaths involving fentanyl increased nearly every quarter to more than 5,800 deaths.
 
Crude and age-adjusted rates of drug overdose deaths involving fentanyl
 
The age-adjusted rate of drug overdose deaths involving fentanyl was 0.5 per 100,000 in 2011 and 2012, and approximately doubled each year from 0.6 (2013) to 1.3 (2014) to 2.6 (2015) to 5.9 (2016) (Figure 2, Table 2). From 2011 through 2013, there was no statistical change in the age-adjusted rates, but from 2013 through 2016, the rates increased on average by about 113% per year. The crude rates were similar to the age-adjusted rates for the study period.
 
Rates of drug overdose deaths involving fentanyl by sex of decedent
 
For males, age-adjusted rates for drug overdose deaths were stable from 2011 through 2013, and then increased by 125.6% per year from 2013 through 2016 (Figure 3, Tables 2 and 3). For females, the age-adjusted rates increased exponentially from 2011 through 2016. In 2011, 2012, and 2013, the rates for males and females were similar at 0.6 to 0.7 per 100,000 for males, and 0.4 to 0.5 for females. Starting in 2013, the rates diverged, with the rate for males increasing more rapidly than the rate for females. By 2016, the rate for males (8.6) was 2.8 times the rate for females (3.1). 
 
Rates of drug overdose deaths involving fentanyl by age group
 
Exponential increases in rates from 2011 through 2016 were observed among all age groups (Figure 4, Tables 2 and 3). The largest average annual percent change from 2011 through 2016 occurred among young adults aged 25–34 (100.0% per year) and 15–24 (93.9% per year). The smallest average annual percent change occurred among adults aged 65 and over (41.6% per year). The rate for adults aged 35–44 was stable from 2011 through 2013, then increased by 123.7% per year from 2013 through 2016. In 2016, the rates were highest among adults aged 25–34 and 35–44 at 13.4 and 11.4 per 100,000, respectively.
 
Rates of drug overdose deaths involving fentanyl by race and ethnicity
 
The age-adjusted rates for drug overdose deaths involving fentanyl increased exponentially among all the racial and ethnic subgroups examined (Figure 5, Tables 2 and 3). Rates for non-Hispanic white persons ranged from 0.7 to 0.8 per 100,000 from 2011 through 2013, then increased by 108.8% from 2013 through 2016. Non-Hispanic black persons had the largest annual percentage increase in rates from 2011 through 2016 (140.6% per year), followed by Hispanic persons (118.3% per year). Rates for non-Hispanic white persons were greater than other subgroups throughout the study period. The rates for non-Hispanic black and Hispanic persons were similar from 2011 through 2013, then diverged from 2014 through 2016. In 2016, the rates were highest among non-Hispanic white persons (7.7), followed by non-Hispanic black (5.6) and Hispanic (2.5) persons.
 
Rates of drug overdose deaths involving fentanyl by public health region
 
Rates of drug overdose deaths involving fentanyl increased exponentially from 2011 through 2016 for most public health regions (Figure 6, Tables 2 and 3). The greatest rate increases were in Region 1 (CT, ME, MA, NH, RI, and VT), Region 2 (NJ, NY, and NYC), Region 3 (DE, DC, MD, PA, VA, and WV), and Region 5 (IL, IN, MI, MN, OH, and WI), which increased 113.9%, 110.9%, 103.6%, and 102.2% per year, respectively. Rates were similar across all public health regions in 2011. In 2016, the rates for Regions 1, 2, 3, 4, and 5 were higher than for Regions 6, 8, 9, and 10. In 2016, rates ranged from 0.8 per 100,000 (Region 9) to 19.8 (Region 1).
 
Discussion
 
This report illustrates the rise in drug overdose deaths involving fentanyl in the United States from 2011 through 2016. The number of drug overdose deaths involving fentanyl increased from 1,663 in 2011 to 18,335 in 2016. Beginning in the fourth quarter of 2013, the number of deaths increased every quarter. From 2013 through 2014, the death rate more than doubled.
 
The absence of drug-specific information on the death certificate does not mean that fentanyl was not present; rather, it may suggest that toxicology tests were not performed or were inadequate to detect the drug. Also, new fentanyl analogs are being identified with increasing frequency and are often lethal in very low concentrations. Detection of these substances requires new testing materials and continuous recalibration of toxicology laboratory equipment (16), both of which can be complicated and expensive, thus further contributing to variation in death reporting across the country.
 
The need to understand the factors influencing overdoses and deaths involving fentanyl has resulted in collaboration among public health agencies, medical examiners and coroners, and public safety agencies. These collaborations will contribute to better detection and reporting on death certificates, which in turn, will help improve quality of local, state, and national vital statistics data.
 
Conclusion
 
Fentanyl is increasingly involved in drug overdose deaths nationally. This report uses NVSS–M data, enhanced with literal text from death certificates, to provide a picture of temporal trends, demographic characteristics, and geographic patterns of fentanyl-involved drug overdose deaths in the United States from 2011 through 2016.
 

Monday, March 25, 2019

More Information on Periodontal Disease and the Potential Increased Risk for Dementia

In case you haven’t noticed (and I’ll bet that you have) the mouth is connected to the rest of the body.  Following that thought to its logical conclusion, therefore diseases of the mouth can also cause diseases of the body.  For years now we’ve been seeing more and more data showing bacteria from the mouth showing up in infections and lesions throughout the body.  The latest investigations have been seeing links between periodontal disease and dementia, up to and including Alzheimer’s disease.
While those of us in the trenches of clinical dentistry have been aware of these links for some time now, this type of information is not always something that makes its way into the general news cycle so often times the public isn’t aware of important information like this.  However, recently a study that appeared in the Journal of the American Geriatrics Society was discussed in an article in Forbes.  When information gets into a publication like Forbes, I’m optimistic that the general public will soon be aware.
The study titled Association of Chronic Periodontitis on Alzheimer's Disease or Vascular Dementia included 262,349 patients and they were followed over 10 years (from 2005-2015).  The study appears to be well done and solidly performed.  It can be read in its entirety at the Wiley Online Library.  Which also includes graphs and tables.  A portion of the study is included below:
Dementia is considered one of the leading causes for increased disability‐adjusted life years among older adults.1 It was estimated that approximately 36 million people had dementia in 2010.2 Furthermore, the prevalence of dementia is expected to increase globally due to the rising life expectancy worldwide. According to one report using the United Nations worldwide population forecasts, it was estimated that 1 in 85 individuals will be diagnosed with Alzheimer's disease (AD) by 2050.3 Interestingly, a 2014 study suggested that a 20% reduction of key exposures could lead to a 15.3% decrease in dementia prevalence by 2050, highlighting the importance of determining risk factors that could lead to dementia.4Therefore, the need is increasing to identify and manage risk factors associated with dementia. One such risk factor is chronic periodontitis (CP).
Multiple animal5 and human6-9 studies previously showed an association between CP and dementia. Most recently, a retrospective cohort study demonstrated that CP patients had a significantly higher risk of AD compared with those without CP.10 However, previous studies had limitations in the relatively small sample size, no consideration of dementia outside of AD, and by the lack of consideration of important confounders such as lifestyle behaviors. Because one of the suggested mechanisms of the risk‐increasing effect of CP on dementia is by inducing vascular damage,11, 12 other types of dementia such as vascular dementia (VD) may be at elevated risk among CP patients. Furthermore, lifestyle behaviors such as smoking, alcohol consumption, and physical activity are all considered risk factors for both CP and dementia, and they are thus potentially important confounders that must be considered.
Therefore, further studies on the association between CP and dementia are needed using a large study population, with consideration of an extensive number of covariates, and determining the risk of other types of dementia such as VD. In this longitudinal population‐based study, we determined the association of CP on AD and VD using the Korean National Health Insurance Service (NHIS) database using a wide range of covariates including smoking, alcohol consumption, and physical activity.
Methods
Study Population
The study population was derived from the National Health Insurance Service‐Health Screening Cohort (NHIS‐HEALS). In South Korea, the NHIS provides mandatory health insurance covering nearly all forms of healthcare for all Korean citizens.13 Records from inpatient and outpatient department visits including diagnosis, drug prescriptions, treatment, and surgical procedures are collected. Furthermore, the NHIS provides biannual mandatory health screening examinations for all enrollees 40 years or older.14 The health screening examination consists of a self‐reported questionnaire on health behavior, body measurements including height, weight, and blood pressure, and blood and urine tests. From this claims database, the NHIS provides a part of its data for research purposes that include information on inpatient and outpatient hospital use, drug prescriptions, death dates, and results from health screening examinations. The NHIS database was previously used for multiple epidemiological studies, and its validity is described in detail elsewhere.14, 15
Among 313 537 participants aged 50 or older, we excluded 31 293 participants who were diagnosed with CP during 2002. Furthermore, we excluded 16 173 participants with missing values on covariates. Finally, 1942 and 1780 participants who were diagnosed with dementia or died before the index date were excluded, respectively. The final study population consisted of 262 349 participants. All participants were grouped as healthy (no CP) or diagnosed with CP during 2003‐2004. Starting from January 1, 2005, the participants were followed up until date of dementia diagnosis, date of death, or December 31, 2015, whichever came first.
This study was approved by the institutional review board of Seoul National University Hospital (IRB number E‐1801‐019‐912). The requirement for informed consent was waived because the NHIS‐HEALS database is anonymized with strict confidentiality guidelines.
Key Variables
CP was defined as being diagnosed with CP according to the International Classification of Diseases, Tenth Revision (ICD‐10 code K05.3), and having undergone at least one of the CP‐related treatments.16 The considered CP‐related treatments were subgingival curettage, periodontal flap operation, gingivectomy, and odontectomy.16 Participants who were not diagnosed with CP and did not undergo CP‐related treatment were considered healthy. Dementia was defined as being prescribed with dementia‐related drugs under a diagnosis for AD (ICD‐10 codes F00, G30) or VD (ICD‐10 code F01).17 The considered dementia‐related drugs were donepezil, galantamine, rivastigmine, and memantine.17
The considered covariates included age (years, continuous), sex (categorical, men and women), household income (categorical, first, second, third, and fourth quartiles), smoking status (categorical, never, past, and current smoker), alcohol consumption (categorical, none, 0‐1, 1‐2, 3‐4, and ≥5 times per week), physical activity (categorical, none, 1‐2, 3‐4, 5‐6, and 7 times per week), body mass index (continuous, kg/m2), systolic blood pressure (continuous, mm Hg), fasting serum glucose (continuous, mg/dL), total cholesterol (continuous, mg/dL), and Charlson Comorbidity Index (categorical, 0, 1, 2, ≥3). Household income was derived from the insurance premium, and body mass index was calculated by dividing height in meters by weight in kilograms squared.
Statistical Analysis
Cox proportional hazard regression was used to determine the adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) of overall dementia, AD, and VD according to CP. Furthermore, we conducted a stratified analysis for the association of CP on dementia according to subgroups of smoking, physical activity, and alcohol consumption. Finally, a sensitivity analysis on the effect of CP on dementia after excluding participants diagnosed with dementia up to 5 years after the index date was conducted.
Statistical significance was considered at P < .05 in a two‐sided manner. All data analyses were conducted using SAS software v.9.4 (SAS Institute Inc, Cary, NC).
Results
Table 1 shows the descriptive characteristics of the study population. Among 262 349 participants, 216 005 did not have CP and 46 344 were diagnosed with CP. The mean age for healthy and CP patients were 60.4 years (standard deviation [SD] = 7.7) and 60.2 years (SD = 7.3), respectively. The percentages of male healthy and CP patients were 49.4% and 56.8%, respectively. Compared with healthy participants, CP patients tended to have higher proportions of men, have higher household income, smoke, consume more alcohol, and exercise more.

Thursday, March 21, 2019

DMG Offers Two New CE Opportunities for Provisional Restorations


Live webinar and recorded podcast help clinicians enhance outcomes and efficiency

Those of you who are interested in great learning experiences are in for a treat.  Two incredibly knowledgeable and entertaining speakers are going to be providing some great information courtesy of DMG.  Dr. David Little and Dr. Gary Radz will both be bringing their clinical experiences, tips, and tricks to 2 different programs.  I’ve known both of these gentlemen for well over ten years and I can tell you first hand that these guys are the real deal.  After these programs you will have good info that you can immediately put to place in your practice the very next day.  Quite honestly, I cannot say enough good things about these 2 individuals.  They are not only tremendous teachers, they are tremendous human beings as well.
Make sure that you set time aside to get these 2 programs into your schedule.  Oh, and be sure to patronize DMG for being gracious and smart enough to provide these programs.

Here is all the info:

DMG, a leading manufacturer of dental restorative materials and preventive products, announced a new webinar and a new podcast that offer continuing education on the
topic of provisional restorations.

At 7:00 pm ET on Thursday, March 28, 2019, David Little, DDS will conduct a live webinar titled “Solutions for Implant Supported Provisional Restorations.” The webinar will focus on a discussion of materials and techniques for direct implant provisionals as well as indirect techniques, including digital technology. The topic will be of great interest to any clinician who places implants, as provisional restorations play a vital role in achieving predictable and successful outcomes in implant dentistry.

Interested clinicians can register for the webinar at http://dmglearning.com/upcoming.asp. For those who cannot view the live webinar, it will be available on an on-demand basis beginning in early April at
http://dmglearning.com/training.asp. Both live and on-demand viewers will receive 1.0 CEU.

In addition, DMG has released a new podcast, “Efficiencies in Fabrication of a Long Term Provisional Crown.”  Featuring an interview with Gary Radz, DDS, the episode discusses how efficiency can be enhanced in the fabrication of long term provisional crowns as well as in clinical applications and techniques while delivering excellent outcomes. The 15-minute episode, for which listeners will receive 0.25 CEU, can be accessed at https://vivalearning.com/member/podcast.asp?x_podcastId=115.

For information about DMG and its category-defining products, please visit https://www.dmg-america.com/.

About DMG

DMG America LLC manufactures and distributes market-leading restorative materials and preventive products that are internationally recognized for their quality and innovation. Known for breakthrough
material technology, including flagship products Luxatemp, LuxaCore Z Dual, and the revolutionary Icon resin infiltrant, DMG is committed to helping the dental profession meet its materials needs through
innovation, collaboration and dedication. For more information about DMG products, or to find a sales representative, visit them online at dmg-america.com, or call (800) 662-6383.

ADDRESS

DMG America
65 Challenger Road, Suite 340 Ridgefield Park, NJ 07660 | USA

Wednesday, March 20, 2019

Off to the Thomas P. Hinman Dental Meeting

 

I’m off to Atlanta to lecture for the Thomas P. Hinman dental society and their superb Hinman Dental Meeting.

Over the years, I’ve been incredibly blessed to be given the opportunity to lecture at a lot of meetings, and the Hinman meeting ranks up there as one the most amazing experiences.  It delivers top-notch education in a tremendous environment and is topped off by tremendous Southern Hospitality.  The good folks at the Hinman Dental Society do a lot of wonderful things for the profession and the Thomas P. Hinman Dental Meeting is just one of them.  I always have a great time when I’m there and I am truly honored to help carry on the tradition started by Dr. Hinman back in the late 1800’s.  Dr. Hinman had a strong belief and focus on education and that has continued at the meeting to this day.
While I’m there, I’ll be teaching a hands-on course on Endodontics for the General Practitioner, a course on the benefits and science of clinical lasers, and one of my favorite lectures to present “Day to Day Technology” that is a chance for me to share about many of the tech tools that I use on a daily basis.
If you’re at the meeting, please be sure to look me up and say hi.  If you haven’t decided on all of your courses yet, I’d be honored to have you participate in one of mine.
Here is the history of the meeting.  After reading this, I’m confident that you will understand why I am so honored to be asked to be a part of it...
The History of Hinman
The Thomas P. Hinman Dental Meeting is sponsored by the Hinman Dental Society, a non-profit organization. The first meeting was held in 1912 by Dr. Thomas P. Hinman and was considered to be the first clinic strictly for serious-minded educational purposes. The meeting developed a reputation for devotion to detail and hospitality that continued to grow through the years with every meeting. These qualities are represented in the motto: Devotion to detail is the secret of success.

Born in 1870, Thomas Hinman graduated from Southern Dental College in Atlanta with his Doctor of Dental Surgery degree in 1891. The following year, he joined the faculty of his alma mater and became Professor of Oral Surgery. Dr. Hinman held high offices in many professional organizations including the appointment by President Woodrow Wilson as the U.S. Delegate and Honorary Chairman of the Section VIII of the Fourth International Congress of Dentists in London. This nomination was considered one of the highest tributes in the dental world.

The first classes for the Atlanta Midwinter Clinic, later renamed the Hinman Dental Meeting, were initially limited to 40 dentists with strict focus on education. The attendee was honor bound to return to his state dental society and present what he had learned in a formal program.

By the late ‘20's, the clinic was attracting national attention. Year after year, featured clinicians and attendees spread the word about the informative programs offered and the extraordinary hospitality extended to them. As the meeting grew, the location changed. The first meetings were held in the Piedmont Hotel, the Ansley Hotel, and, later, the Biltmore Hotel.

Exhibits were introduced in 1942 with 14 booths appearing in the Ballroom at the Biltmore Hotel. The meeting then moved to the Atlanta Municipal Auditorium at Courtland and Gilmer Streets in 1944 followed by the move to the new Atlanta Marriott Motor Hotel in 1966. In 1977, the meeting expanded to the Atlanta Hilton and Towers, and in 1986, it shared space between the Hilton and the new Atlanta Marriott Marquis. With the continued growth of meetings and exhibits, the Society voted to move the meeting to the Atlanta Market Center, using exhibit and meeting space in INFORUM, the Apparel Mart and the Merchandise Mart. In 1998, the meeting moved to the Georgia World Congress Center.

In 2018, nearly 20,000 dental professionals participated in the 106th annual Thomas P. Hinman Dental Meeting at the Georgia World Congress Center and Omni Hotel at CNN Center. The exhibits program included representatives from nearly 400 companies occupying more than 800 booths. Attendees were housed in 23 hotels in downtown, midtown, and Buckhead. They traveled from all 50 states and as far away as Japan and New Zealand.

Today, the focus is still on providing the best possible continuing dental education, not just for the dentists but also, the whole dental team. The program addresses the needs of the general dentists, specialists, hygienists, assistants, front office staff, laboratory technicians and students.

The Hinman Dental Society today is comprised of 800+ dentist members, primarily located in metropolitan Atlanta. The membership responsibilities include service during the meeting each year. This service enhances the reputation for unparalleled hospitality to continue. The combination of outstanding education and hospitality ensures the position of the Hinman Dental Meeting as one of the top dental programs in the country. 

The excess revenue of the Meeting is invested and then gifted in the form of scholarships to individuals and institutions that foster dental education whether at the undergraduate or post-graduate level. The society has provided nearly $8,600,000 in total giving.

Tuesday, March 19, 2019

Wolverine Solutions Group Notifies 600,000 Patients of Data Breach

 
The breaches just keep on occurring and I keep reporting them in an attempt to help you readers understand how important data security is and how vigilant we all need to be.  If the professionals in this space are getting hacked, it’s that much easier for the bad guys when they turn their attention on us.
 
This latest event comes from the state of Michigan where a company named Wolverine Solutions Group has announced a breach that affected over 600,000 patients.  The company "performs services for health-related business clients”.  Among those clients is Blue Cross Blue Shield of Michigan, Helath Alliance Plan, Three Rivers Health, North Ottawa Community Health System, Mary Free Bed Rehabilitation Hospital, Covenant Hospital, Sparrow Hospital, and McLaren Health Care.  
 
In September, WSG was hit by a Ransomware attack which caused hard drives containing patient data to become encrypted and therefore inaccessible.  The company began to decrypt the files beginning on October 3rd and managed to get all files restored by October 25th.
 
The company began notifying patients and updated their announcement on February 27th, 2019.
 

 

Wolverine Services Group (“WSG”) performs services for health-related business clients, including various health plans and hospital systems (“Healthcare Clients”). We are posting this statement on our website as a precautionary measure and as part of our commitment to patient privacy. WSG takes patients’ privacy seriously, and it is important to us that you and the community that we serve are made fully aware of a recent security incident at WSG, which potentially involves personal information of health plan members and hospital patients.

 

On approximately September 25, 2018, WSG discovered that an unauthorized party gained access to its computer system and infected the system with malware. The malware encrypted many of WSG’s records, which made them inaccessible, in an effort to extort money from us. This is commonly referred to as “ransomware.”

Shortly after WSG learned of the incident, we began an internal investigation and hired outside forensic security experts to help us. A team of forensic experts arrived on October 3, 2018 to begin the decryption and restoration process. All impacted files needed to be carefully “cleaned” of any virus remnants prior to their review by forensic investigators. Most critical programs requiring decryption were restored by October 25, 2018, and WSG’s critical operations were running by November 5, 2018. However, the forensic team continued its decryption efforts on the impacted files to determine the type of information that was affected, the identities of our Healthcare Clients, and the specific individuals involved. Beginning in November and continuing in December, January, and early February, WSG discovered and was able to identify those Healthcare Clients whose information was impacted by the incident. The timing of our notices to impacted individuals has been based on these “rolling” discovery dates.  The first notices were mailed on December 28, 2018. Additional notices have been mailed in February and further notices will be mailed in March.  

 

As a result of our investigation, WSG believes that the records were simply encrypted. There is currently no indication that the information itself was extracted from WSG’s servers. Nevertheless, given the nature of the affected files, some of which contained individual patient information (names, addresses, dates of birth, social security numbers, insurance contract information and numbers, phone numbers, and medical information, including some highly sensitive medical information), out of an abundance of caution, we mailed letters to all impacted individuals recommending that they take immediate steps to protect themselves from any potential misuse of their information.

 

WHAT WE ARE DOING

 

WSG is taking steps to guard against identity theft or fraud. We arranged for affected individuals to have AllClear ID protect their identity. The following identity protection services start on the date of the individual receiving a notice letter and can be used at any time during the next 12 months.

 

AllClear Identity Repair: This service is automatically available to you with no enrollment required. If a problem arises, simply call 855-861-4034and a dedicated investigator will help recover financial losses and restore your credit.

 

AllClear Fraud Alerts with Credit Monitoring: This service offers the ability to set, renew, and remove 90-day fraud alerts on your credit file to help protect you from credit fraud. In addition, it provides credit monitoring services, a once annual credit score and credit report, and a $1 million identity theft insurance policy. To enroll in this service, you will need to provide your personal information to AllClear ID. You may sign up online at enroll.allclearid.com or by phone by calling 855-861-4034. You will need to contact AllClear to obtain a Redemption Code to enroll in this services.

 

We also want to note that following your enrollment, additional steps are required by you in order to activate your AllClear phone alerts and fraud alerts, and to pull your credit score and credit file. Additional steps may also be required in order to activate your monitoring options.

 

We recommend you remain vigilant and consider taking one or more of the following steps to protect your protected health information or personal information:

 

Contact the nationwide credit-reporting agencies as soon as possible to add a fraud alert statement to your credit file at all three national credit-reporting agencies;
Remove your name from mailing lists of pre-approved offers of credit for approximately six months;
Receive a free copy of your credit report by going to www.annualcreditreport.com;
Pay close attention to all bills and credit-card charges you receive for items you did not contract for or purchase;
Review all of your bank account statements frequently for checks, purchases, or deductions not made by you;
If you suspect or know that you are the victim of identity theft, you should contact local police and you also can report this to the Fraud Department of the FTC.
We also recommend that you regularly review statements from your accounts (i.e., account statements and Explanations of Benefits (“EOB”)) and periodically obtain your credit report from one or more of the national credit reporting companies. You may obtain a free copy of your credit report online at www.annualcreditreport.com, by calling toll-free 1-877-322-8228, or by mailing an Annual Credit Report Request Form (available at www.annualcreditreport.com) to: Annual Credit Report Request Service, P.O. Box 105281, Atlanta, GA, 30348-5281. You may also purchase additional copies of your credit report by contacting one or more of the three nationwide consumer reporting agencies listed below.

 

Equifax:           P.O. Box 740241, Atlanta, Georgia 30374-0241, 1-800-685-1111, www.equifax.com

 

Experian:         P.O. Box 9532, Allen, TX 75013, 1-888-397-3742, www.experian.com 

 

TransUnion:    P.O. Box 1000, Chester, PA 19022, 1-800-888-4213 www.transunion.com

 

When you receive your credit reports, account statements and EOBs, review them carefully.  Look for accounts or creditor inquiries, transactions or services that you did not initiate or do not recognize.  Look for information, such as home address and Social Security Number, which is not accurate.  If you see anything you do not understand, call the consumer reporting agency at the telephone number on the report, the company issuing the account statement, your provider rendering services or the insurance company issuing your EOB. Additional information regarding Identity Theft Protection is available here.  We have also posted a list of Frequently Asked Questions, which is available here.

 

We take the protection of your personal information seriously and took steps to prevent a similar occurrence. We migrated to a different computer system that has added protections and trained our workforce in safeguards.

 

If you have further questions about identify protection services, please contact enroll.allclearid.com or by phone by calling 855-861-4034.  We sincerely apologize to you and all our Healthcare clients for concern caused by this incident.

 

Sincerely,

Wolverine Solutions Group

Monday, March 18, 2019

Even the Watchers are Vulnerable to Security Problems

 
 
 
 
In this world where data security is of the upmost importance for both confidentiality AND to avoid costly fines, even those who are in charge of enforcing the regulations must be constantly vigilant of their own data security.
 
The OIG (Office of Inspector General) or the U.S. Department of Health and Human Services, has released a report detailing its penetration testing of several different HHS networks.  Pen testing as it’s known stands for “penetration testing” and is basically utilizing any and all methods to get past security.  This includes both hardware & software hacking over the Internet as well as “Social Engineering” which is convincing someone to give you information that they shouldn’t via some method of manipulation.  
 
No matter who you are, everyone needs to be aware of the ways data can be compromised, and in actuality, it’s more common for social engineering to at least start the process than just straight out hacking.  So even though HHS is in charge of enforcing the laws regarding patient data security, they also are subject to attacks and need to be prepared and informed.
 
To that end, the OIG ran penetration testing on 8 HHS Operating Division Networks and here is what they found:
 
We conducted a series of audits at eight HHS Operating Divisions (OPDIVs) using network and web application penetration testing to determine how well HHS systems were protected when subject to cyberattacks.

 

Our objectives were to determine whether security controls were effective in preventing certain cyberattacks, the likely level of sophistication an attacker needs to compromise systems or data, and HHS OPDIVs' ability to detect attacks and respond appropriately.

 

During fiscal years 2016 and 2017, we conducted tests at eight HHS OPDIVs. We contracted with Defense Point Security (DPS) to provide knowledgeable subject matter experts to conduct the penetration testing on behalf of OIG. We closely oversaw the work performed by DPS, and testing was performed in accordance with generally accepted government auditing standards and agreed-upon Rules of Engagement between OIG and the OPDIVs.

 

On the basis of the systems we tested, we determined that security controls across the eight HHS OPDIVs needed improvement to more effectively detect and prevent certain cyberattacks. During testing, we identified vulnerabilities in configuration management, access control, data input controls, and software patching.

 

We shared with senior-level HHS information technology management the common root causes for the vulnerabilities we identified, information regarding HHS's cybersecurity posture, and four broad recommendations that HHS should implement across its enterprise to more effectively address these vulnerabilities. We also provided separate reports with detailed results and specific recommendations to each OPDIV after testing was completed. We will be following up with each OPDIV on the progress of implementing our recommendations.

 

Based on the findings of this audit, we have initiated a new series of audits looking for indicators of compromise on HHS and OPDIV systems to determine whether an active threat exists on HHS networks or whether there has been a past breach by threat actors.

 

We provided to HHS a restricted roll-up report of the results of our testing at the eight OPDIVs. The report included four broad recommendations that HHS should implement across its enterprise.

 

In written comments on our draft summary report, HHS management concurred with our recommendations and described actions it has taken or plans to take to ensure they are addressed. HHS also indicated that the OPDIVs have incorporated actions to address their individual vulnerabilities and that HHS will follow up with them to ensure that these have all been addressed.

 

We would like to thank HHS and its OPDIVs for the cooperation we received throughout the penetration testing.

Thursday, March 14, 2019

Last Chance Online Registration for ALD 2019: Dentistry’s Laser Meeting

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“The Laser-Systemic Connection: Lighting the Way to a Healthier Mouth and Body” is Taking Place in Dallas on April 4th-6th in Dallas, Texas

 

The Academy of Laser Dentistry (ALD), the only independent and unbiased non-profit association dedicated to improving patient care with the proper use of laser technology, is announcing that March 29th will be the last day to register online for its upcoming annual conference and exhibition.

We’ll still accommodate on-site registrations during the conference, but lectures are expected to be standing room only and several hands-on workshops are already sold out,” explained ALD executive director Gail Siminovsky, CAE.  

Known internationally as “Dentistry’s Laser Meeting”, ALD 2019 is at the Hilton Dallas/Plano/Granite Park from April 4th – 6th. The meeting’s focus is “The Laser-Systemic Connection: Lighting the Way to a Healthier Mouth and Body.”

We’re very excited about the theme of ALD 2019,” said Siminovsky. “For decades, ALD members were the unsung heroes of oral-systemic health. First by applying laser technology to treat periodontal disease and more recently, by applying light therapy to help patients suffering from the oral mucositis side-effects of chemotherapy, TMJ, sleep apnea and other medical conditions.”

The educational tracks and workshops that support the laser-systemic connection theme include the following:

• Innovation, Wellness and Medically Compromised Patients
• Periodontal Disease Diagnosis and Treatment
• Photobiomodulation
• Obstructive Sleep Apnea

The ALD 2019 program is rounded out by educational sessions and/or workshops on the following topics:

• Hygiene
• Pediatric Dentistry
• Endodontics
• Implantology
• Oral Surgery
• Laser Safety Training
• Financial Planning/Wealth Management

Kicking off ALD 2019 will be keynote speaker Charles Whitney, MD, the nation’s leading physician advocate for bridging the oral-systemic gap. Dr. Whitney’s specialty of heart attack, stroke and dementia prevention relies heavily on collaborating with dental clinicians to accurately diagnose and effectively treat periodontal disease.

Dr. Whitney’s presentation will help ALD 2019 attendees connect the dots on how to bring the message of oral-systemic connections into their practices, “I love watching the lightbulb go on in the eyes of my audience when they learn how to take the oral-systemic message to the streets,” commented Whitney. “I hope I can help ALD members recognize that on a good day they can save a tooth and on a great day they can save a life! “

What’s more, Dr. Whitney has seen first-hand the beneficial effects of laser dentistry on his own patients. In fact, he recently referred one of his patients to ALD incoming president Dr. Mel Burchman, who successfully treated the patient’s chemo therapy-induced oral mucositis with photobiomodulation therapy.

“Having Dr. Whitney as our opening keynote speaker will certainly set the tone for ALD 2019,” explains Siminovsky. “Our goal for this meeting is to be the world’s go-to event where the entire dental team can learn how to bridge the oral-systemic gap using laser technology.”

Watch the ALD 2019 preview video by clicking http://bit.ly/2TOAlOL. Register online until March 29th by visiting https://ALD2019.com.

About the Academy of Laser Dentistry:

The Academy of Laser Dentistry (ALD) is the only independent and unbiased non-profit association devoted to laser dentistry and includes clinicians, academicians and researchers in all laser wavelengths. The Academy is devoted to clinical education, research, and the development of standards and guidelines for the safe and effective use of dental laser technology. ALD was founded in 1993, with the merging of the International Academy of Laser Dentistry, the North American Academy of Laser Dentistry and the American Academy of Laser Dentistry. For more information, visit www.LaserDentistry.org.

 

Wednesday, March 13, 2019

Benco and VOCO Announce New Partnership

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Benco Dental announces a new partnership with VOCO, an almost 40-year global leader in the manufacturing of dental materials and technologies.  This collaboration delivers VOCO’s extensive product line of high- quality direct and indirect materials and digital workflow technologies to Benco customers.
 

Benco Dental, headquartered in Northeastern Pennsylvania, is the largest family-owned dental distributor in the United States, offering a full array of supplies, equipment and services to dentists across the nation. Within the past 88 years, the company has developed distribution innovations that have become industry standards and in 2018, launched an Innovation Index. This key metric tracks the percentage of products sold that were introduced in the previous three years.

Based out of Cuxhaven, Germany, VOCO performs extensive research and development in the fields of direct and indirect restoratives, oral care and digital dentistry, setting new standards in the creation of innovative dental products and application aids to provide better solutions to dentists throughout the world. VOCO researchers partner and maintain close contact with over 150 universities and research institutes worldwide, and have been leading several research projects co-sponsored by the German Federal Ministry of Research. This has enabled VOCO to act as a technological forerunner in several material development areas. As a leader in Nano-technology, VOCO products have received high praise and recognition in the U.S. with top ratings from The Dental Advisor, Reality and other independent institutes.

VOCO exports to over 100 countries on six continents. Benco’s national network includes five distribution centers and three design showrooms and features a highly-skilled team of more than 400 professionally trained sales representatives and over 300 factory-trained service technicians.

For details, visit benco.com or call 1.800.GO.BENCO.

Tuesday, March 12, 2019

NSA to Release Ghidra Reverse Engineering Software Tool for Free Download

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Your Tax Dollars at Work!
 
At a recent security conference, RSA, a new reverse engineering software tool was demonstrated by none other than the National Security Agency.  The super secret government organization is the one that provides cyber security as well as cyber tracking.  Osama Bin Laden’s courier was tracked to the house in Abbotobad by these folks.  The group is so super secret about what it does that, for a while, the government would neither confirm nor deny its existence leading to the joke that NSA stood for “No Such Agency”.  This cyber spying agency has been known to break into systems world wide to aid national intelligence.
 
That’s why this story is such a big deal.  NSA’s Senior Advisor Rob Joyce demonstrated the tool which is called “Ghidra”.  In addition to providing a demonstration to the conference attendees, Joyce also made the announcement that the NSA would make the program available for download and they’ve also made it open source.  That means the program will be free and others can tinker and make improvements in it.  Although not yet available, when it is you will be able to download it from this link.
 
Ghidra is said to be a very powerful SRE (software reverse engineering) tool.  It is written in Java which means it is pretty much operating system agnostic.  That will allow it to run on Linux, Windows, and Mac easily.  Because it is in Java there isn’t even an install routine.  Simply download and run.
 
This should provide some fun for tinkerers and some real help for professionals looking to peer into the inner workings of programs.
 
Of course it also makes you wonder.  If the NSA is giving this away it must be no longer useful to them.  What are they using now and how robust is whatever it is?  This is one of those great mysteries that truly, for almost all of us, has no answer.  Still it’s fun to ponder.  These types of security things fascinate me.  If you are a diehard gear head, get your hands on this tool and see what it can do. 

Monday, March 11, 2019

‘Dozens’ of Northwestern Memorial Hospital Employees Fired for Accessing Jussie Smollett’s Medical Records

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Here is an interesting story that I came across and I feel really compelled to share it with you.  As regular readers of the blog know, I’ve got a serious interest security and since I’m also in the healthcare area, that translates to also being concerned about patient data security and PHI (Protected Health Information).  Usually when I think of a HIPAA violation I think of some type of data breach where an intruder steals patient data.  However, this case is completely different and even though it may not apply to very many dental scenarios (as dental offices have exponentially fewer employees) I think it still information that is pertinent to a security discussion.
 
While most of you in dentistry probably do not have a practice filled with celebrities, there are still some lessons to be learned from this story.  The biggest and most important lesson is employees need to know that they can only access PHI if they have a legitimate reason to do so.  
 
The following story is from the HIPAA Journal and details how Northwestern Memorial Hospital in Chicago dealt with employees who choose to access the records of Jussie Smollett without proper authorization or medical reason to do so.  It’s an article that provides some good lessons.
 

A major case of snooping on celebrity medical records has been reported that has resulted in ‘dozens’ of healthcare workers being fired from Chicago’s Northwestern Memorial Hospital for accessing the medical records of Jussie Smollett without authorization.

Jussie Smollett attended the hospital’s emergency room for treatment for injuries sustained in an alleged racially motivated attack by two men on January 29, 2019.

Following a police investigation into the alleged attack, Chicago Police Superintendent Eddie Johnson announced that the Empire actor had been arrested on February 21 and charged with disorderly conduct and filing a false police report. The police allege that the attack was a hoax and that it had been staged by Smollett as a publicity stunt.

Curiosity got the better of some employees at Northwestern Memorial Hospital who searched for Smollett on the hospital’s system, some of whom accessed his chart and viewed his medical records.

Accessing the medical records of patients without authorization is a violation of Health insurance Portability and Accountability Act (HIPAA) Rules and can result in disciplinary action and, in certain cases, criminal penalties for the employees concerned.

Northwestern Memorial Hospital reviewed PHI access logs and took decisive action over the privacy violations. Employees found to have snooped on Smollett’s medical records were fired.

Northwestern Memorial Hospital has neither confirmed that Smollett was a patient nor provided information about the number of employees that have been terminated, stating that HIPAA prevents such information from being disclosed.

Some employees that were terminated have spoken to the media about the incident. CBS Chicago claims dozens of hospital employees have been terminated for the HIPAA violations while NBC Chicago has reported there have been at least 50 terminations for snooping.

Thursday, March 7, 2019

Colgate® Announces Recipients of the Colgate Award for Research Excellence (C.A.R.E.)

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I’m always grateful for those who do research.  Science is a difficult job, but without it advancement in every area of our lives would come to a screeching halt.  The health sciences have expanded their knowledge bases exponentially over the last few years and we owe a debt of gratitude to those folks who toil everyday in a lab/research based world for that knowledge.  Because of that, it’s always awesome to see companies recognize the scientists who work for all of this knowledge, doing so simply because they love what they do and want to see suffering end.

So I was excited to learn about this research recognition program that is done by Colgate.  I want to express my gratitude to Colgate for providing these awards.

 

Colgate is pleased to announce this year’s recipients of the Colgate Award for Research Excellence (C.A.R.E.). The C.A.R.E. Program recognizes a new generation of academic researchers by providing up to $30,000 USD (per project) to support oral health research projects across multiple disciplines.

The four junior faculty members chosen to receive this year’s awards are:

• Abdelhabibe Semlali, MS, PhD — Laval University, Faculty of Dentistry, Quebec, Canada.
Research Topic: “Investigation of a Curcumin Analog (PAC) for oral diseases treatment.”

• Annie Shrestha, BDS, MSc, PhD, FRCD (C) — University of Toronto, Faculty of Dentistry, Ontario, Canada.
Research Topic: “Injectable, Thermosensitive Scaffolds Modulate Immune Cells and Regulates Healing.”

• Brian Partido, MSDH, BSDH — The Ohio State University, College of Dentistry, Columbus, Ohio.
Research Topic: “Impact of peri-implant treatment using glycine powder air-abrasive debridement on the oral microbiome.”

• Keith Da Silva, DDS, MSc, FRCD (C) — University of Saskatchewan, College of Dentistry, Saskatoon, Saskatchewan, Canada.
Research Topic: “Developing a multi-disciplinary and integrated approach to improve oral health for vulnerable children in Saskatoon.”

Proposals were reviewed by an independent, esteemed group of senior academic dental researchers. Winners were selected based on program criteria, which included innovation, clinical significance, originality, and scientific quality. C.A.R.E. grants are typically offered for periods of 12 months.

“The C.A.R.E. Program fosters the development of junior faculty by providing seed research funding to emerging leaders in academia at a time in their career path when it is most needed,” said Maria Ryan, Vice President and Chief Dental Officer, Global Technology at Colgate. “Every year, we look forward to meeting and supporting talented researchers in the early stages of their careers. We are pleased to fund innovative projects that promise to advance industry knowledge and perhaps even revolutionize the field of dentistry. On behalf of Colgate, sincere congratulations to the winners of this year’s grant awards.”

Established in 2016, the Colgate C.A.R.E. Program is designed to foster and provide financial support to young academic researchers. In order to be eligible for the Colgate C.A.R.E. grant, faculty applicants must be in the first five years of an academic appointment.

For more information about the Colgate C.A.R.E. Program for Young Academic Researchers and application guidelines, visit www.colgateprofessional.com/care-program (USA) or www.colgateprofessional.ca/en-ca/care-program (Canada).

 


ABOUT COLGATE-PALMOLIVE

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care, and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, EltaMD, PCA Skin, Ajax, Axion, Fabuloso, Soupline, and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet. For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit http://www.colgatebsbf.com.

Wednesday, March 6, 2019

New Material Under Development May Increase Longevity of Dental Composite Restorations

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Researchers at Oregon Health & Science University have been working on a way to improve dental composite restorations (white fillings).  Currently the research team feels they have created a material that might be able to double the life of fillings.  Currently the standard placement of composite fillings last somewhere between 5-10 according to the majority of studies done on the subject.  OHSU researchers are hoping to double that.
 
Perhaps one of the best things about this discovery, at least for me, is that one of the researchers and developers is Dr. Jack Ferracane.  I’ve known Dr. Ferracane for several years and he is well respected in the industry and a researcher at the top of his game.  Many discoveries show incredible promise but fail to deliver.  I’m optimistic that, with his involvement, this situation will come to fruition.
 
The team is using Thiourethane-Modified fillers to increase the strength of the material and this seems to show great promise in the lab and the results are intriguing and promising.
 
The original report can be found at nature.com if you want to see the tables or download and save it.  In case you just want to read it, here it is:
 
Toughening of Dental Composites with Thiourethane-Modified Filler Interfaces

Ana P. Fugolin, 
Daniel Sundfeld, 
Jack L. Ferracane & 
Carmem S. Pfeifer

Abstract
Stress of polymerization is one of the most significant drawbacks of dental resin composites, since it is related to poor marginal adaptation, postoperative pain, and secondary caries. Previous studies have shown that thiourethane oligomers incorporated into the organic matrix represents a promising strategy to reduce stress and increase fracture toughness in dental composites. However, this strategy promotes a significant increase of the viscosity system, which may represent a challenge for clinical application. The objective of this study was to functionalize the surface of inorganic filler particles with thiouretanes and evaluate the impact on mechanical properties and kinetics of polymerization. Our results showed that composites filled with thiourethane-silanized inorganic fillers showed up to 35% lower stress while doubling mechanical properties values. This was achieved with no prejudice to the viscosity of the material and following a clinically acceptable photoactivation protocol.
Introduction
Resin composites are widely used for direct restorative procedures due to their esthetics and generally acceptable mechanical properties. However, composite restorations last an average of only about 10 years1, with failures being more commonly associated with material fracture and secondary decay2. Stress generation has been hypothesized to facilitate bacterial infiltration and biofilm formation at the interface between the tooth and the restoration, and when combined with composite material degradation by hydrolysis and enzymatic attack, may explain the relatively short life-time of composite restorations3. Therefore, research efforts have concentrated on modifying composition to render the composite material less prone to stress generation at the bonded interface4, and more resistant to fracture5.

Recent studies6,7,8,9 have demonstrated the potential of a relatively simple approach to improve conversion and fracture toughness of dental resin-based composites, while at the same time reducing polymerization stress. It has been shown that the addition of relatively small concentrations of thiourethane oligomers to the organic matrix of resin composites and luting cements leads to a 50–60% reduction in stress and a two-fold increase in fracture toughness6. Since the additive is simply incorporated into the traditional composite during formulation, no modification of the normal operatory technique is required, which in turn should facilitate its translation to clinical practice6. These benefits are achieved through the presence of pendant thiol functionalities on the backbone of the thiourethane additive6. As it has been widely demonstrated for thiol-ene10 and thiol methacrylate reactions11, thiols, via chain-transfer reactions, lead to delayed gelation and vitrification in vinyl-based polymer networks. This, in turn, allows for greater conversion to be achieved12, and for modulus development in the material to be delayed to higher conversion values11, ultimately leading to lower contraction stress generation. In addition, thiol-containing networks have been demonstrated to produce materials with narrow tan delta peaks in dynamic mechanical analysis11, characteristic of more homogeneous polymer networks13. This, combined with the flexibility of thio-carbamate bonds, results in increased toughness8 and reduced polymerization stress14.

One potential pitfall of including pre-polymerized additives, however, is the increase of viscosity, which limits the amount that can be incorporated into the monomer matrix. The addition of thiourethanes above 20 wt% in concentration increases the viscosity of the monomer mixture, which prevents the incorporation of adequate amounts of inorganic filler, and also leads to a slight decrease in elastic modulus6.

One possible way to incorporate the thiourethane oligomer in the composite material and overcome the viscosity issue is to attach it directly to the surface of the filler particle via common silanization procedures15. Others have demonstrated the use of polymer brushes to functionalize silicon-containing surfaces16 with reported decrease in polymerization stress, as well as evidence for strengthening mechanisms such as crack deflection17. Considering the average surface coverage with conventional methacrylate silanes (about 5%) for a composite with 70 wt% filler content, it should be possible to incorporate an equivalent amount of thiorethane in the composite. In that case, the oligomer is distributed throughout the material through attachment to the filler particles, with no negative effect on the viscosity of the monomer matrix itself.

The aim of the present study was to examine different properties of resin composites containing inorganic filler particles silanized with a thiourethane oligomer obtained by the combination of tri- and tetra-functional thiols with different isocyanates. The hypotheses of the study were: (1) Filler particles functionalized with thiourethane will be easily distributed into a resin matrix without negatively affecting kinetics of polymerization and depth of cure, and (2) fracture toughness will be improved and stress polymerization reduced in the groups with thiourethane-silanized particles.
Results
Thermogravimetric Analysis
The TGA results showed that the TU fillers had at least 48.5% more organic content than the commercially obtained methacrylate-silanized filler, i.e., particles functionalized with thiourethanes showed more oligomer available on the filler surface than the commercial particles silanized with methacrylate 

Fracture toughness, polymerization stress, degree of conversion, and viscosity
Compared to the composite with the unsilanized filler and the control with a methacrylate silanized filler, the KIC was significantly increased by the addition of thiourethane-silanized particles, and polymerization stress was significantly reduced (Table 2). In terms of KIC, the exception was TMP:BDI, which presented values statistically similar to SIL-MA control group. In terms of stress, all thiourethane-modified groups presented lower stress than the control, except for PETMP:BDI and PETMP:DHDI, which had similar values compared to the control. In general, the addition of thiourethane-silanized filler particles increased or did not influence the final DC and the viscosity of the composites. DC values ranged from 42–50% (Table 2). TMP:DHDI presented higher values than the controls (SIL-MA and UNS) and PETMP:BDI, and similar to TMP:BDI, TMP:HDDI, PETMP:HDDI, and PETMP:DHDI. Viscosity results ranged from 15.0–11.5 Pa.s and, in general, thiourethane-silanized filler groups presented similar or lower values than the controls.

Polymerization reaction kinetics
There was statistical difference between the maximum rate of polymerization values (Rp max, Table 3). TMP-DHDI was greater than all groups, except for UNS and PETMP-HDDI. The lowest results were obtained for SIL-MA. Figure 1 shows the kinetic profiles for all tested groups. The degree of conversion at maximum rate of polymerization (DC at Rp max), used to estimate the conversion at the onset of vitrification, ranged from 7–14%, and showed a tendency for higher values with the groups containing BDI as the isocyanate, but which presented values similar to SIL-MA.

Depth of polymerization
The degree of conversion as a function of depth is depicted in the 2-D maps shown in Fig. 2. Similar or higher degree of conversion was observed for TU silanized filler groups in relation to the control groups at all depths. In many cases, the depth of cure is defined as the depth at which degree of conversion (or hardness) falls below 80% of the top or maximum value. In this case, all materials showed a depth of cure of at least 3.5 mm, the full depth of these specimens.

Discussion
The addition of thiourethane oligomers to methacrylate-based resin materials has been shown to increase the degree of conversion and fracture toughness, while simultaneously reducing polymerization stress6,7,8,9. In those previous studies, the limitation for the incorporation of oligomers (at about 20–30 wt% of the organic matrix mass) was dictated by an increase in viscosity, which in turn precluded the incorporation of inorganic fillers to the level necessary to produce adequate mechanical properties6. One way to possibly overcome this limitation was tested in this present study: to functionalize the thiourethane oligomers with trimethoxy silane functionality, so that the oligomer itself could be later tethered to the surface of the inorganic filler particle via common silanization procedures15. In this way, we aimed to improve the distribution of the oligomer within the composite, and to harness the same benefits obtained with the incorporation of the oligomer directly in the matrix, but without the drawback of significant increase of the viscosity. In fact, our results have shown that even for the fully formulated, highly filled composite, the viscosity average for the TU-silanized materials were similar or lower than the control groups (Table 2).

In the present study, the concentration of thiourethane used in the silanization procedure was kept constant at 2% of the total mass of the silanizing solution. The resulting fillers were characterized with thermogravimetric analysis to determine the extent of final surface coverage on the particles. It is important to note that even the unsilanized particles showed some mass loss after the test, likely due to the presence of organic contamination. The same contamination is unlikely to be present on the surface of the silanized filler particles, given the fact that the silanization process entails exposure to organic solvent in an acidic environment. In addition, the fillers were kept in sealed containers after silanization, so it is reasonable to assume that the mass loss in those cases was due to mainly the silane coating. The percent of surface functionalization based on the mass loss ranged from 5.45–9.21%, with the TU fillers showing at least 50% greater functionalization in comparison to the methacrylate control (Table 1). Since the filler particles in all formulations had the same size distribution, this difference in part likely reflects the higher molecular weight of the thiourethane silane (around 5 kDa6) as compared with the methacrylate silane (around 0.25 kDa), rather than indicating a more extensive surface coverage. Other studies evaluating silicon-containing surfaces functionalized with polymer brushes found similar results and attributed the mass loss to the formation of a coat of brush heap structures at the surface16,18. In the current study, given the loosely crosslinked nature of the oligomer formed, the surface coating is likely less organized than a conventional polymer brush16. In any case, when the percentage of filler surface coverage was calculated based on the mass loss from the TGA experiment, the average thiourethane concentration in the six composites containing the TU filler was found to be 7.2%. This is nearly one third of the amount of TU added to the resin matrix in previous studies to produce the same effects, such as increased fracture toughness and reduced polymerization stress6.

Degree of conversion for the TU filler composites (except for TMP-BDI) was on average 5–7% higher than for the control (SIL-MA). Previous studies have demonstrated the potential of the chain breaking events caused by the presence of thiols to delay gelation and vitrification in radical polymerizations19. In this reaction, the chain-transfer events lead to a delay of the point in conversion at which monomer mobility limitations hamper polymerization and, thus, allow higher final conversion and delayed modulus development, ultimately delaying and reducing stress development20. Based on these mechanisms and our previous results obtained when incorporating the thiourethane oligomers directly into the organic matrix, it was expected that thiourethane-silanized materials would not only show increased degree of conversion, but that they also would be able to reduce the rate of polymerization and delay vitrification7. The delay in vitrification was estimated by the conversion registered at the onset of deceleration (Rpmax). Contrary to what was expected for the reaction rate, all of the groups containing the thiourethane-silanized filler showed equivalent or higher maximum rate of polymerization compared to the methacrylate control. However, all of the composites with TU filler showed equivalent or significantly lower DC at Rpmax. In any case, there was no significant correlation between the measured stress and the Rpmax or measured stress and DC at Rpmax. One possible explanation is that the overall concentration of thiourethane in the present study was lower, and therefore, the effects on network formation were not as marked as had been seen previously. In addition, because the incorporation of the thiourethanes to the filler surface did not affect the material’s viscosity, its effect on early mobility restrictions observed with the thiourethanes added directly into the matrix was not observed here. Even though gelation and vitrification were not directly assessed in this study, the kinetic profiles are strong indicators for those events21, and it can be speculated that these did not play a role in the decreased stress observed, which then must be explained by other factors.

A specifically low irradiance was used for the kinetics test in order to highlight the differences between the tested thiourethanes. However, to better reproduce clinically relevant conditions, selected groups (Sil-MA, PETMP:BDI and PETMP:HDDI) were evaluated for polymerization kinetics under the same conditions described previously but at a much higher irradiance of 650 mW/cm2. The results (Fig. 3) showed that the polymerization was much faster than with the low irradiance, as expected, but also that there was no significant difference between the groups in terms of Rpmax (3.04, 2.97 and 2.88%.s−1, respectively) and DC at Rpmax (11.8, 13.1 and 13.2%, respectively). Further, the TU-silanized groups showed 4–6% higher final DC than the methacrylate-silanized control, which is in agreement with our previous results22. In combination with the depth of cure data, this shows the general ability of the thiourethanes to maintain or increase the degree of conversion and improve homogeneity of the polymer network, likely due to the chain-transfer mechanism leading to the delayed gelation/vitrification, thus maximizing the degree of conversion before the reaction becomes diffusion-controlled11. Among the tested thiourethanes, PETMP–containing materials showed higher conversion than the control at the bottom of the specimen for two out of the three groups, whereas TMP only led to higher conversion at the bottom for the combination with the DHDI isocyanate, as shown in the heat map plots. This is at least in part explained by the fact that PETMP is tetrafunctional and TMP trifunctional, which results in higher concentration of thiol functionalities pendant from the thiourethane backbone6 available on the filler surface to undergo the chain-transfer mechanism. The cyclic isocyanate DHDI led to consistently high and more uniform conversion throughout the specimen, likely because it represented an intermediate between the stiff backbone imparted by the presence of the aromatic BDI and the highly flexible backbone imparted by HDDI. Interestingly, for the more highly crosslinked PETMP-containing TUs, the use of HDDI led to higher initial DC and then essentially equivalent DC as with DHDI throughout the specimen9,23. As the refractive index is expected to increase with the addition of any of the TU silanes, leading to improved light transmission22, the depth of cure was expected to increase for all TU-containing groups. However, as shown on the plot for percent cure in depth in relation to the conversion at the top, two of the three PETMP are actually the lowest depth of cure in percentage, but when PETMP is paired with DHDI the depth of cure is still high. In fact, the DHDI-containing groups present the highest values in terms of cure throughout, and at the greatest depth (though not the highest absolute conversion value at the top). The TMP groups present the best percent depth of cure with DHDI, and then even slightly better than PETMP when paired with BDI and HDDI. It is important to highlight that the degree of conversion is high throughout the specimens, so these differences are likely non-clinically relevant. In summary, this study demonstrates that TU-additives are capable of maintaining the high conversion at the top throughout the specimen much more efficiently than the non-modified control, and highlights the influence of the TU structure on depth of cure.

There was a significant 15–35% reduction in polymerization stress for materials containing thiourethane silanized filler particles. As previously mentioned, this was true in spite of the apparent lack of delayed gelation/vitrification phenomena, at least as inferred from the polymerization kinetics curves. In this case, other factors likely contributed to the reduced stress values observed. The TGA results demonstrate that the filler coverage with the thiourethane silane represents between 5.4 to 9.2% of the mass of the filler, as compared to only 3% for the methacrylate silane controls. Two factors need to be considered: 1. the same amounts by weight of each molecule were used during the silanization, and 2. each methacrylate silane molecule presents only one trimethoxy silane functionality, compared to multiple functionalities for the TU oligomer silane. Therefore, it is possible that the methacrylate silane formed a mono-layer of molecules, and the TU-silane likely formed a much thicker layer on the filler surface. Also, due to the greater complexity of the molecular structure of the TU-silane, even with a greater mass of silane, it is very unlikely that the surface was covered to the same extent as with the methacrylate silane. It follows that the stress reduction mechanism may stem from two factors. The first is the possibility for the surface of the particle to be more exposed (“unsilanized”) for the TU silane than for the methacrylate controls, which would then reduce stress because the filler particle in part actually acts as a void. This type of behavior was shown when non-silanated nanoparticles were used to fill dental composites24. However, this was not observed here, as the non-silane treated filler showed equivalent stress to the methacrylate-silane control. This suggests that the fillers acting as pores is not likely the explanation for this result. The second, and arguably the most relevant factor relates to the flexible and tough nature of the thiourethane networks, as extensively demonstrated in the literature7,9,23,25. It can be speculated that the presence of the TU around the filler particles acted to locally relieve the stress developed during polymerization, which then resulted in overall less stress generation in the composite. In fact, this mechanism has been proposed in other studies evaluating the efficacy of polymer brush functionalization on stress reduction at interfaces with silicon-containing materials17. Polymer brushes or tethered polymers may stretch away from the surface and accommodate for the change in free volume that accompanies polymerization26,27. Another possible explanation is active strand behavior, demonstrated recently for urethane-containing materials28.

It is important to note that the stress reduction (and also the effect on polymerization kinetics) were dependent on the molecular structure of the precursors used to synthesize the thiourethane silanes. Overall, the groups where the tri-functional thiol (TMP) was used as a precursor exhibited lower stress than groups containing the tetra-functional thiol (PETMP), which then correlates with the likely greater degree of crosslinking provided by PETMP. This has been previously shown in studies using dynamic mechanical analysis to evaluate crosslinking (via the rubbery plateau method)29. Therefore, the more crosslinked material likely produced a stiffer network around the filler particle, which was then less able to relieve stress. Interestingly, the use of more rigid isocyanate precursors (BDI, containing aromatic moieties) did not seem to influence stress development more or less than the other TU silanes, suggesting that the structure of the TU oligomer itself, independent of its base monomer structure, had the greatest influence on stress reduction. The loss and storage modulus obtained with dynamic mechanical analysis (data shown in the Supplementary Information) also demonstrate the lack of correlation between the TU structure and property development, corroborating the fact that the thiocarbamate-based structure has a greater influence on stress development and mechanical reinforcement.

The same mechanisms used to explain stress relief and ultimately overall stress reduction can be used to explain the fracture toughness results. Thiourethane silanized particle groups showed a 25–85% increase in fracture toughness compared to the control groups. Fracture toughness may be important to help predict the clinical behavior of the dental composite restoration as it is related to chipping and bulk fracture30,31. When thiourethanes are added into the methacrylate matrix, the improvement of the mechanical properties is attributed to the flexible nature of the covalent bonds formed between the thiol on the thiourethane with the methacrylate via chain-transfer reactions8, leading to a more uniform and tougher network14,32. In the present study, those flexible bonds were formed around the filler particles, a region where stress concentration occurs33. This, in conjunction with the tough nature of the thio-carbamate bonds in the oligomer structure, likely led to some crack deflection or crack shielding mechanism around the particles33,34, as has been suggested by nanomechanical analysis of silicon interfaces treated with polymer brushes. It is also possible that the thiourethane-based silane bonding to the methacrylated matrix was more efficient due to its multiple methoxysilane functionalities, which could have enhanced the filler particle-matrix interaction leading to an increase in mechanical properties. Furthermore, fracture toughness is correlated to tensile stresses build up around the filler particles, and the efficiency of silane treatment plays an important role in gap formation35. Therefore, it can be speculated that the interfacial bonding between the organic matrix and filler particles was strong enough to resist the polymerization shrinkage, creating fewer gaps. PETMP groups showed better performance than TMP (increase between 40–85% for PETMP groups versus 0–40% for TMP groups) which may be due to PETMP being tetrafunctional while TMP is trifunctional. The greater crosslinking improved the mechanical strength of the matrix around the particles, and while that likely resulted in less efficient stress relief, as described earlier, it led to reinforcement of the material overall. The isocyanate structure did not influence the results, though a trend could be observed for increased mechanical properties and decreased polymerization stress, which could be due to the more flexible nature of this material9,23.

In general, the results of this study demonstrate that the incorporation of thiourethane silanized fillers into resin composites led to increased conversion at faster rates than the control, while increasing fracture toughness, and reducing stress of polymerization. Even though the microbiological aspect was not considered on the scope of this investigation, these materials might be able to reduce gap formation, and hamper bacterial colonization at the bonded interface, ultimately helping avoid restoration failures due to secondary decay. Studies are underway utilizing a secondary caries model to test this hypothesis.
Materials and Methods
Material Composition
The experimental composites were composed of Bis-phenol A diglycidyl dimethacrylate (Bis-GMA), urethane dimethacrylate (UDMA) and triethylene glycol dimethacrylate (TEGDMA) at a 50:30:20 mass ratio. All monomers were purchased from Esstech (Essington, PA, USA). Photoinitiators were added to the monomers as follows: 0.2 wt.% of dl-camphoroquinone (Polysciences Inc., Warrington, PA, USA), 0.8 wt.% of a tertiary amine (EDMAB – ethyl 4-dimethylaminobenzoate; Avocado, Heysham, England), and 0.2 wt.% inhibitor (BHT – 2,6-di-tert-butyl-4-methylphenol; Sigma–Aldrich, St. Louis, MO, USA).

Six thiourethane oligomers were synthesized in solution in the presence of catalytic amounts of triethylamine. Two multi-functional thiols – pentaerythritol tetra-3-mercaptopropionate (PETMP) or trimethylol-tris-3-mercaptopropionate (TMP) – were combined with three di-functional isocyanates – 1,6-hexanediol-diissocyante (HDDI) or 1,3-bis(1-isocyanato-1-methylethyl) benzene (BDI) (aromatic) or 1-isocyanato-4-[(4-isocyanatocyclohexyl) methyl] cyclohexane (DHDI) in 60 ml of methylene chloride. In addition, 1 mol of 3-(triethoxysilyl)propyl isocyanate was also added to each of the six combinations described above – this is the source of trimethoxy silane to be used for the subsequent silanization step. The reaction was catalyzed by triethylamine. The isocyanate:thiol mol ratio was kept at 1:2.5 (with thiol in excess) to avoid macro-gelation of the oligomer during reaction, according to the Flory–Stockmayer theory21, leaving pendant thiols and trimethoxy silanes. Oligomers were purified by precipitation in hexanes and rotoevaporation, and then characterized by mid-IR and NMR spectroscopy6. The disappearance of the isocyanate mid-IR peak at 2270 cm−1 and the appearance of NMR resonance signals at 3.70 ppm were used as evidence for completion of isocyanate reaction and thiourethane bond formation, respectively36.

For the silanization procedures, thiourethane oligomers were combined with 65 ml of an ethanol: distilled water solution (80:20 vol%), previously acidified by the addition of glacial acetic acid (pH = 4.5). Thiourethane was added at 2 wt%, in relation to the solution mass. Five grams of neat barium silicate glass filler (average size = 1.0 ΞΌm; Kavo Kerr Corporation, Orange, CA) was added to the solution, kept under magnetic stirring for 24 hours, filtered, and dried for 4 days in an oven at 37 °C.

The TU fillers were introduced at 50 wt% to the monomer matrix with a centrifugal mixer (DAC 150 Speed Mixer, Flacktek, Landrum, SC, USA) operated for 2 min at 1800 rpm. All procedures were carried out under yellow light.

Control groups were prepared with a commercially available unsilanized (UNS) and methacrylate-silanized (SIL-MA) barium glass filler particles (average size = 1.0 ΞΌm; Kerr Corporation, Orange, CA). All photocuring procedures were carried out using a mercury arc lamp (EXFO Acticure 4000 UV Cure; Mississauga, Ontario, Canada) filtered at 320–500 nm (light guide diameter = 5 mm). In order to verify the achieved functionalization and its efficiency, the different filler particles were analyzed by thermogravimetric analysis (TGA) over a temperature range of 50 °C to 850 °C at 10 °C/minute.


Fracture Toughness (K IC)
KIC was determined using the single-edge notch beam method. Specimens were fabricated according to ASTM Standard E399–9037 by filling a 5 × 2.5 × 25 mm (n = 6) split steel mold with a razor blade insert providing a 2.5 mm long notch in the middle of the specimen. The resin composites were photoactivated for 2 min on each side at an irradiance of 800 mW/cm2. The light guide was kept 7 cm away from the sample and a radiometer (Power Max 5200 – Laser Power Meter, Molectron, Portland, OR, US) was used to measure the power output from the mercury arc lamp and guarantee that 800 mW/cm2 irradiance reached the top surface of the sample. The bending fracture test was performed using a universal test machine (MTS Criterion, Eden Prairie, MN USA) at a cross-head speed of 0.5 mm min−1 and KIC was calculated according to the following equation (1):

𝐾𝑖𝑐=3𝑃𝐿2π΅π‘Š32{1.93(π‘Žπ‘Š)12−3.07(π‘Žπ‘Š)32+14.53(π‘Žπ‘Š)52−25.11(π‘Žπ‘Š)72+25.8(π‘Žπ‘Š)92}Kic=3PL2BW32{1.93(aW)12−3.07(aW)32+14.53(aW)52−25.11(aW)72+25.8(aW)92}
(1)
where P is load at fracture (N), L is the length, W is the width, B is the thickness, and a is the notch length (all in mm).


Polymerization Stress
Polymerization stress in real-time was analyzed using a cantilever beam apparatus (Bioman) previously described38. The surface of the fused silica plate was treated with a thin layer of silane ceramic primer (3 M ESPE, St. Paul, MN, USA) and the surface of the 5 mm diameter steel piston with Z-Prime Plus (Bisco Inc., IL, USA). The composite was then inserted into the 1-mm gap between the upper rod and the lower glass slide and shaped into a cylinder, removing the excess. The samples were light-cured through the glass using the light curing unit for 40 s (n = 5) at 280 mW/cm2. Data were recorded for 10 min on a computer and the final shrinkage-stress calculated.


Kinetics and Degree of Conversion
Three specimens (8 mm in diameter and 0.6 mm in thickness), laminated between two glass slides, were cured and then measured with near-infrared (NIR) spectroscopy (Nicolet 6700, Thermo Electron Corporation, Waltham, MA, US) to calculate the degree of conversion (DC). The area corresponding to the methacrylate double bond overtone at 6165 cm−1 39 was recorded before and after 300 s of irradiation with the light source located 4 cm from the surface of the glass slide, delivering 20 mW/cm2 directly to the specimen. Real-time monitoring of the polymerization kinetics for 300 s was carried out on specimens of the same size at 2 scans per spectrum with 4 cm−1resolution.


Depth of polymerization – 2D Mapping with IR-Microscopy
Samples (2 × 5 mm cross-section and 5 mm depth) were prepared using silicon molds (n = 3) and photocured through a glass slide for 300 s at 20 mW/cm2. After 7 days dry storage, the samples were embedded in slow curing epoxy resin and then sectioned using a diamond saw (Accutom-50) to obtain two slices of 0.4 mm thickness. The degree of conversion of the vinyl groups with depth was measured in near-IR (6165 cm−1) using an IR microscope attached to a spectrometer bench (Continuum and 6700, Thermo Fisher). 2D surface maps of conversion were set up with 200 Β΅m step sizes.


Viscosity
Viscosity was measured in a cone-plate rheometer (ARES, TA Instruments, New Castle, DE, USA). 1.03 g of each unpolymerized resin was placed between 20-mm diameter plates and tested at 1 Hz with a gap size of 0.3 mm (n = 3).


Statistical Analysis
Data for each property was tested for normality and homocedasticity (Anderson-Darling and Levene tests, respectively), and then analyzed with one-way ANOVA and Tukey’s test for multiple comparisons. The significance level was set at 95%.