MLK’s Words Resonate, a Lesson for Us All…

More than half a century after Martin Luther King Jr.’s  “I Had a Dream Speech” in Washington D.C., his words resonate more than ever, a timeless creed of indignation and hope. We embrace his words as constant reminders of some things in the past we must tear ourselves from and a future we cannot totally see.

Dr. King’s speech, in soaring rhetoric, was expert testimony of the great need for dramatic public health, judicious and societal reform as he spoke of a country that included the “lonely island of poverty” and the “unspeakable horrors of police brutality.”

As he stood Aug. 28, 1963 in the shadow of the Lincoln Memorial, Dr. King talked of what we were as a nation, what we said we were supposed to be, and the sharp distance between the two.

Today, we have made much progress since Dr. King’s speech, indeed, through a vast array of  federal regulation and civil action over the years, leading to education and housing opportunities unheard of in 1963, environmental and judicial reforms, in a society with improved overall health.

But we have a long way to go.  As we battle a paralyzing Covid-19 pandemic, Dr. King’s words constantly ring in our ears, his stirring voice echo in our hearts.  Fifty-seven years after Dr. King’s speech,  police brutality still haunts with the slaying three months ago in Minneapolis of George Floyd, an African-American man killed at the hands of a white police officer. It haunts again, repeatedly. On Aug. 23, Jacob Blake was shot seven times in the back after he walked away from officers, in Kenosha, Wis. It unleashed anger in the streets and a vast call for change through peaceful protests, the kind that Dr. King so often led. Police violence, often an outgrowth of racial profiling and structured racism, epitomizes a public health crisis.

Poverty, too, is relentless in its reach today among Blacks and other minorities with racial disparities, too often prevalent in housing, jobs and income, with its resulting widespread impact on public health.

Since Dr. King’s speech, there have been great political strides in much of American society. With Barack Obama, a Black man became president of the United States. With Sen. Kamala Harris (D-Calif.) as former Vice-President Joe Biden’s running mate in the upcoming Presidential race, there is a woman who is Black and South Asian-American running for Vice-President.

Yet Black voters face many obstacles in their hope of registering to vote, the unavailability of voting centers at a time of COVID-19, or even having their mail-in ballots counted. As we have  been overwhelmed by the pandemic, it has been more severe in Black and Hispanic communities, related to a host of factors, including housing and especially working conditions leaving them more exposed to the virus, and a public health threat.

Dr. King talked of the Declaration of Independence as the “promise that all men, yes, black men as well as white men, would be guaranteed the unalienable rights of life, liberty and the pursuit of happiness,” King said. “It is obvious today, that America has defaulted on this promissory note insofar as her citizens of color are concerned.”

Dr. King said that Black Americans and others were still waiting to “cash a check.” In some ways, they still are.

We must march ahead for justice, he said.

Today, many are gathered near the Lincoln Memorial for “Commitment March: Get Your Knee Off Our Necks.”

It is no time to turn back. – Joe Cantlupe, Health Data Buzz

Envisioning Zero

We acknowledge with a heavy heart this tragic milestone of nearly 100,000 American deaths since the COVID-19 outbreak began in late February in the U.S. where there are now 1.6 million cases.

Family, friends and other loved ones of those who have perished because of COVID-19 are constantly in our thoughts.

As we tally these numbers, we measure them in sadness but also with a resolve to overcome obstacles and early miscues that may have contributed to thousands of lives lost. We now must forge ahead with the science that guides public health every day to minimize the spread of the disease, work to reduce COVID-19 illnesses and ultimately find a vaccine.

At least 2,000 people are dying each day because of COVID-19 in the U.S., which has the most cases in the world, where more than 300,000 deaths have been recorded and more than 5 million cases.

There is no doubt that sufficient containment measures in testing, isolating or lockdowns, social distancing, wearing masks and contact tracing must continue with determination and strength.

States and cities that have resolved to take on those measures are making progress, while others who have not are struggling in their fight against the spreading infection.  Overall, infection rates are slowing in the U.S., but they remain steady in at least 25 states.

Ultimately, on this Memorial Day weekend, we begin to envision the only number that will truly matter: Zero.  It cannot be a mirage but one for which we are all in this fight together. — Joe Cantlupe, Health Data Buzz

Stepping up drug development. Oh yes, there’s that pandemic, too.

from my story at Academic Pharmacy Now

Talk to academics involved in The National Institute for Pharmaceutical Technology & Education (NIPTE) and they will tell you it’s about striving and thriving in innovation—inside and outside the walls of academia. NIPTE has collaborated with industry, academia and government, particularly the Food and Drug Administration (FDA), to identify and help solve the world’s pharmaceutical challenges, which are far-reaching and keep growing. NIPTE scientists are exploring more effective methods for the characterization of active pharmaceutical ingredients and drug products. They are identifying strategies to prevent drug opioid addictions. They are charting ways to improve dosage form design and manufacturing. They are exploring how to determine the quality of pharmaceuticals.

In addition, they are creating education and training programs that focus on evolving technology in pharmaceutical science and engineering with an eye on thwarting future workforce shortages. And they are part of the conversation in Washington on accelerated drug development plans in light of pandemics such as the coronavirus.

Most recently, NIPTE is studying plans to essentially overhaul the process for bringing generic medicines to market that its scientists say could take dramatic steps to improve safety and quality while enhancing pharmaceutical production in the U.S. “We define ourselves as a community of pharmaceutical knowledge and the scientific home for academic pharmaceutical sciences,” said Dr. Vadim J. Gurvich, executive director of NIPTE and research associate professor of medicinal chemistry at the University of Minnesota College of Pharmacy. The organization, established in 2005 and based in Minneapolis, is a coalition of academic scientists from pharmacy, education, engineering and chemistry and includes 16 universities with pharmaceutical education and research programs and one medical school. Each university member’s representative serves on the NIPTE board of directors, providing leadership and financial oversight.

“From our perspective, there is a tremendous potential to draw together subject matter experts in the academic world and being able to connect those experts to either industry or other regulatory agencies, such as the Food and Drug Administration, to address some of the grand challenges as we move forward,” said Dr. Eric Barker, dean of the Purdue University College of Pharmacy and secretary of the NIPTE board. “We’re able to have collaborations and partnerships with members to draw together on their collective expertise.”

The mission: increase science and engineering-based understanding that can lead to new drug products to move to market faster with less variability and higher predictable performance at a lower cost, said Gurvich. For example, researchers are studying abuse-deterrent protocols, intervention-based opioid technology, nanotechnology, advanced manufacturing methods and the formulation of new drug products, “which is extremely challenging, cutting-edge science that addresses a huge societal need,” he added.

Preparing the Workforce

Education and skills development in pharmaceutical science are essential elements in preparing a new workforce, according to Gurvich. At NIPTE, courses are taught based on what the organization calls a “quality and integrated review concept” involving product development, delivery, manufacturing and outcome—with collaboration as a key with schools of pharmacy and engineering. Chemistry and materials science are also included in NIPTE’s strategic roadmap.

NIPTE said its scientists organize into centers of excellence and focus groups to “more efficiently collaborate and integrate their expertise across member organizations.” The focus groups target advanced manufacturing, biologics and biosimilars, nanotechnology and translational biomarkers. The idea is to link all areas within the scope of pharmaceutical production, from development to manufacturing.

“Large data has advanced more quickly than our ability to analyze the data and that’s a challenge,” said Barker. “That we cannot go alone. We can draw and tap into (NIPTE’s) tremendous expertise in engineering and even agriculture. That’s a factor for both basic knowledge and having a program to train data scientists to upskill the existing workforce—not expecting them necessarily to be experts but competent enough to work with the data.”

NIPTE’s examination of dosages (i.e., dosage forms) and complex molecules and specialty drug technology ties into Purdue’s strategic initiatives to expand its area of pharmaceutical and biotechnology instruction from basic science to clinical science for “cutting-edge educational programming,” Barker said. NIPTE has a collection of “a close-knit group of deans,” he said.

Pharmacy a Key Component in FDA’s Drug Manufacturing Strategy

Federal officials are enlisting academia as they look toward a new generation of pharmaceutical manufacturing methods to overcome the country’s reliance on drugs produced overseas. While the U.S. is a leader in drug discovery and development, it relies heavily on drugs made in China and India. As a result, the Food and Drug Administration is encouraging investments in advanced manufacturing technology and establishing quality management systems to improve the quality of pharmaceuticals.

“FDA believes that advanced manufacturing can help regain its competitiveness with China and other foreign countries and potentially ensure a stable supply of drugs critical to the health of U.S. patients,” said Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research in testimony late last year before the House Committee on Energy and Commerce, subcommittee on Health.

Between 70 and 80 percent of active pharmaceutical ingredients and 40 percent of finished products are made outside the U.S. The FDA reported last year that 18 percent of Active Pharmaceutical Ingredients (API) manufacturing facilities are located in India and 13 percent in China. The number of Chinese manufacturing facilities has doubled since 2010. As of late 2019, only 28 percent of manufacturing facilities making APIs that supply the U.S. market are based in this country.

Vulnerable Supplies

“The fact that so many of our drug products are made overseas creates a vulnerability in the U.S. supply,” said Dr. Fernando J. Muzzio, director, National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems, and distinguished professor, chemical and biochemical engineering, Rutgers University. “The supply chain can be disrupted for lasting shortages. This is a real issue both with shortages caused by emerging quality problems and with the ability to respond quickly to emerging threats.”

Muzzio has worked for years with the National Institute for Pharmaceutical Technology & Education, a proponent of the advanced manufacturing processes with one key purpose in mind: improving the amount and quality of the U.S. drug supply. Proponents of advanced manufacturing say innovative technologies ranging from 3D printing to continuous manufacturing methods also can quickly move drugs to market. The continuous production method stands in contrast to the current predominately used batch method of drug production, which is considered inefficient and involves “breaks” or “stops” in the process.

“Advanced manufacturing offers many advantages over traditional pharmaceutical manufacturing and if the U.S. invests in this technology, it can be used to reduce the nation’s dependence on foreign sources of APIs to increase the resilience of our document manufacturing base and reduce quality issues that trigger drug shortages or recalls,” Woodcock said. Advanced manufacturing has been widely used in automotive, aerospace and semiconducting.

“The continuous state of control enables the continuous monitoring and assurance of product quality,” Muzzio told Congress. Continuous manufacturing has been embraced to replace traditional and inefficient batch methods in an era of “unprecedented innovation” following “decades of near stagnation,” Muzzio said.

Academia is playing a large role with industry and other regulatory agencies to help the FDA identify potential regulatory hurdles to adopt advanced manufacturing, according to Woodcock. In 2018, the FDA awarded eight grants to universities and nonprofit organizations to “study and recommend improvements for the continuous manufacturing of drugs and biological products as well as similar innovative monitoring and control techniques,” she said.

The FDA is working with academia and industry to identify new research areas for advanced manufacturing. FDA laboratories also have conducted advanced manufacturing research and established a Center of Excellence for Manufacturing Science and Innovation to coordinate internal advances in manufacturing research for both small molecules and biologics.

There is a tremendous potential to draw together subject matter experts in the academic world and being able to connect those experts to either industry or other regulatory agencies…to address some of the grand challenges as we move forward. We’re able to have collaborations and partnerships with members to draw together on their collective expertise.D

“Many of the NIPTE labs are doing dosage design research, and some of the information we are generating with prior knowledge may not be seen as cutting-edge research, but for pharmaceutical analysis and formulations and master’s and Ph.D. level students, this is an invaluable learning experience, both in mastering techniques and formulation design,” said Dr. Kenneth Morris, professor and director of Lachman Institute for Pharmaceutical Analysis at the Long Island University Pharmacy, which is a NIPTE member. NIPTE is also working to identify the next compounds and products likely to be important targets for the generic industry, Morris said.

As NIPTE collaborates with the FDA, the organization is also emphasizing the need to overcome workforce shortages in pharmaceutical sciences, according to Gurvich. “That was a big concern for the FDA several years ago and they couldn’t find enough qualified people with appropriate training in pharmaceutical sciences,” Gurvich recalled. “That led them to us, and they approached us to develop a training and certification program, which is very much a work in progress.”

There is irony in the work. As Gurvich and his team strive to improve pharmaceutical manufacturing in this country, “if it starts coming back to the U.S., the industry will face shortages in the workforce and that is another concern,” he said. “At NIPTE we discussed the situation, and (seek) to recalibrate education programs to solve that problem.”

More Accessible Generic Drugs

Even before the alarm over the spread of coronavirus throughout the world this past winter, NIPTE researchers began stepping up their research into improved mechanisms to manufacture and deliver generic drugs into the U.S. market. That market has been saddled by regulatory woes and much production overseas.

“The efficiency of the generic drug product system is quite low,” Gurvich said. “We noticed that about 60 percent of the drugs that are marketed by brand companies are not making it to generics. And that has caught our attention. That feeds into our priorities. It’s extremely important. It affects the drug supply, the quality of drugs, all sorts of things.”

Part of the organization’s strategy to improve access to generic drugs is wrapped around the words “new” and “prior knowledge.” Gurvich said NIPTE is pushing to highlight the distinction between the information that may involve proprietary and trade secrets and available knowledge in the public domain. Using that prior knowledge, he noted, can accelerate development and commercialization of generic drugs.

As an example of “new” and “old,” NIPTE published a paper last year titled “Pharmaceutical New Prior Knowledge: Twenty-First Century Assurance of Therapeutic Equivalence” that referred to manufacturer Apotex’s formulation of a nasal spray product, which used a different drug formulation so as not to infringe on a previous product’s unexpired patent. Years later, the situation changed: The FDA approved the generic version of the drug after the patent’s expiration. “Clearly during this review process, the FDA had access to previously disclosed” information, the paper states. Ultimately, it points to a “need for NPK (new prior knowledge) efforts to bridge the gaps between research to policy and policy to practice,” according to the authors.

Using the terms “new” and “prior knowledge,” Gurvich said, “sounds like an oxymoron. It may be a little bit provocative or paradoxical. But it needs to be taken up by public-private partnerships. NIPTE can be a partner and we had this discussion and talked to the FDA and the idea is we will have the scientific firepower to make a significant impact.”

The Surprising, Surreal, Sad and Sudden Pandemic Age: “Life is what happens to you while you’re busy making other plans” — John Lennon

Covid-19 has brought the world to its collective knees.  The novel coronavirus pandemic that began as a few cases in China now has 3.38 million cases in 187 countries and regions around the globe, and the virus has killed more than 246,000, according to the Johns Hopkins University Coronavirus Resource Center.

Civilization is a shell of its once-vibrant self. Billions of people walking far apart from each other, streets closed, buldings and businesses shuttered, playgrounds empty.  We walk outside, dodging people. Our hands are getting a bit leather. Is there such a thing as too much hand washing. Apparently not. We start noticing the colors of masks, a feature of someone’s attire.  April was dubbed by the poet TS Eliot as the “cruelest month.” This month certainly lived up to Eliot’s description.

While most people try to stay away from each other, some may be afraid that others are getting too close. Many people are obeying the social distancing, but others, not so much. A bit of a crowd hanging outside the restaurant the other day. Too many people gathering around a friend and checking a phone at a park today. The line at the grocery store a bit unnerving. Many states are now opening up. Cringeworthy, I think. It is by maintaining our distance we enhance our shared connection: to overcome the disease. Hopefully, not death by impatience.

For people who struggle with their mental health, the pandemic can worsen their problems. Social isolation and loneliness may open the door to a range of mental health and physical issues from depression to heart disease. The isolation and uncertain well being is particularly hard for the poor, disadvantaged and the elderly.

Along with financial losses, many people are suffering emotionally from home confinement. They feel alone, frustrated and anxious.

Many of the same concerns envelop essential workers, especially those working in hospitals and public health, who face the challenges of having to protect themselves while working to save lives. Workers in construction or food services also go to work, despite the threat of infection.

During this time, it’s a priority for all of us to make time for self care. It’s important to reach out to friends and family, whether by phone or online. Humans are wired for connection, and we need our circle of support. Sleep, physical exercise and a healthy diet are also essential. Going for walks and participating in nature can help reduce stress, as does taking a break from the news.

In these ways, we can develop an inner core of strength and feel we have a sense of control. That’s important, because there is still much uncertainty ahead. Once we reopen for normal activities, people may go back to their old ways, only to find the coronavirus outbreak has flared up again.

We must prepare people for the social, physical and mental health consequences of another explosion of infections. While initial orders to stay at home arrived abruptly and unexpectedly, most people complied to protect themselves and their families. They may be less willing to do so once those policies have been relaxed.

Looking to the future, together

Even as we struggle with the day-to-day realities of the pandemic, we must also look ahead. The public health field has been preparing for the realities of the next pandemic for decades, with “it’s a matter of when, not if,” a long-common refrain among preparedness and infectious disease experts. Yet when COVID-19 arrived, it exposed the gaping holes in our plans. The situation shows the need for strong public health infrastructure, necessitating enough resources and systems to mitigate future problems.

We must examine our workforce to ensure there are proper allocations of labor for the needs of communities, particularly in health care. We must also pay attention to a global supply chain, where reliance on only a few countries for medical supplies, for instance, has proven to be reckless.

Ultimately, a science-based approach is necessary to prepare for what is ahead. We must include full and open participation from our most trustworthy messengers — scientists, public health professionals and medical officials — as we retool and strengthen our health systems to stave off more outbreaks like this one.

The speed in which COVID-19 spread from a few cases in a food market to communities across the world shows that we must act faster — without presumptions that we are immune from “far-off” contagions. With the next worldwide infection only a plane ride away, we must be prepared to come together without politics or prejudice to contain disease outbreaks as soon as they occur, wherever they occur.

No less than the future of humanity is at stake – Joe Cantlupe, Health Data Buzz.

Pharma Fun at VU: Zombie Apocalypse Lab

From my story at Academic Pharmacy Now

There’s the typical pharmacy course where student pharmacists explore lab results, learn about medications and consider patient needs. A course held at the Virginia Commonwealth University School of Pharmacy went with a unique approach, which included this outrageous combination of words: Zombie Apocalypse Lab.

Yes. They’ve done it. They lived to tell.

For two years, the VCU School of Pharmacy has run electives for third-year students in advanced non-sterile compounding with a twist. Enter zombies. Spurred by this bit of horror fantasy, the professors turned a seemingly routine pharmacy course into an edge-of-your-seat experience. That’s because the real world offers those too: natural disasters, floods, power outages. So the professors put a method to the madness by enabling students to prepare pharmaceutical concoctions using the nearest herbs in a lab with no electricity, no running water and only the most antiquated equipment, making the experience as stressful as it could be without the reality of the danger. They pumped dreary music in the background, installed dark garbage bags to block sunlight and assembled cardboard cutouts of “The Walking Dead.” And yes, a zombie or two walking around with streaks of “blood.”

Dr. Lauren Caldas, assistant professor, dreamed up the idea for the elective because she wanted to be innovative and do things a bit differently for the 30 students in the non-sterile compounding course. She recalled saying to her partner, Dr. Abigale T. Matulewicz, also an assistant professor, “Hey, why don’t we do this elective and tie it to Zombie Week?” Both fans of “The Walking Dead,” they jumped on the idea of creating the zombie theme that ran through the course, which allowed students to learn real-life pharmacy skills. The two-week course began with student pharmacists evaluating an herb natural to Virginia that had medical properties that they could develop and ended with a zombie-in-your-face moment where the students had to put together medications in a fake hurry-up scenario to comfort people in pain over tooth ailments, at least in time to flee the clutches of any zombies and get real care.

“The beauty of this was how it teaches the same core concepts without having students reliving the actual traumatic event they’ve gone through,” Caldas said. “We have had students who have gone through a lot, these individual harrowing stories coming from war zones and everywhere. It teaches the same impressive skills of problem solving and thinking on your feet in a more relaxed environment. We wanted to elevate the learning environment and encourage the faculty to get out of their silos.”

I liked the idea of putting a constraint on compounding. When you have all the tools available, that’s not the real world—you have supply and equipment constraints. It highlights that in a fun way, kind of a real-world application. And there was the need to use spot-on critical thinking.MICHAEL ONG, STUDENT PHARMACIST

“We wanted to have the flexibility to do this as a fun thing versus a first-year compounding course, which is content-heavy and doesn’t allow for a lot of creativity,” Matulewicz added. “With a smaller number of students it allows for more unique things that we could do. It was a great way for students to be engaged, and also fun for us to be outside of the traditional teaching setting.”

A Major Ingredient

A key component in the zombie apocalypse course design was an herb that could be a pharmaceutical source with medicinal properties to be used in the event of a catastrophe. Caldas thought of yarrow—a flowering plant known as a hardy perennial that grows in Virginia, essentially in the school’s backyard. The herb was used by Native Americans in the colonial days and is known for having anti-inflammatory and antiseptic properties, Caldas said. It has been used for years for fever, the common cold and even has been chewed on to relieve toothache, which was the source of “pain” for the would-be patients.

“Yarrow grows easily here and it is regularly used as a natural remedy like chamomile,” Caldas said. “Students used this natural product to create their own products, similar to creating a baking recipe from scratch.” That fits perfectly with non-sterile compounding, which is meant for something ingested by the mouth or skin rather than injected.

Caldas, an expert in labeling and dispensing, reached out to the School of Pharmacy’s Dr. Michael Hindle, a professor and expert in pharmaceutical analysis, and one of his doctoral students to research the medicinal properties of yarrow. Hindle spent months evaluating the substance and how students could extract and analyze medication from dried yarrow. At the outset, “we basically started from scratch with hard groundwork reviewing the literature, and sometimes what they do in the literature doesn’t always go as smoothly as described in the paper,” Hindle said.

The team evaluated the herb and analyzed active drug ingredients and what could be extracted from the plant. The aim was to “make it relevant to pharmacy students. This is something they heard about but did not do themselves,” Hindle said. “In turn, they would extract the active ingredient and successfully incorporate it into some compounding product.”

Preparing for the Worst

In the final class, the student pharmacists had a few hours to put together a formula designed to deal with fictitious patients’ tooth ailments before they could get medical care in the face of the zombie apocalypse. Many students focused on making a formula for mouthwash.

And now, Class: Weed 101…(Pharmacy Students Studying Medical Marijuana)

From my story at Academic Pharmacy Now:

Ninety years ago, marijuana was widely known as the “evil weed,” prompting the 1936 propaganda film “Reefer Madness” about its dangers. In the ensuing decades, study after study gradually backed off the hyperbole about marijuana, though it is still under a spotlight of continued research. In today’s world, marijuana is sometimes used to treat what ails us. Pharmacy is keeping pace as medical marijuana goes mainstream.

Pharmacy schools are offering programs to study medical marijuana not only for student pharmacists but others seeking to learn more about it for myriad reasons, including regulatory or business purposes as well as for improved patient care. As the industry expands, more colleges are adding cannabis or marijuana courses to their portfolio. Medical marijuana is gaining traction in America with more states legalizing its use and more dispensaries opening across the country. Some educators point to the increasing need for medical professionals—including physicians, nurses and pharmacists—to properly advise patients about medical marijuana.

At last count, 33 states as well as the District of Columbia, Guam and Puerto Rico have legalized medical marijuana. Three states are already requiring that pharmacists be part of the dispensing process, according to the National Community Pharmacists Association. For instance, New York State requires a pharmacist to be on the premises and supervising the activities within a marijuana dispensing facility.

The legalization movement is expected to broaden to more states. “The number is only expected to increase in the future, fueling a demand for an educated workforce that is well-trained in both the science and therapeutic effects associated with this medicinal plant,” said Dr. Natalie D. Eddington, dean and professor at the University of Maryland School of Pharmacy.

A 2019 study from the University of Pittsburgh School of Pharmacy found that 62 percent of U.S. pharmacy schools surveyed incorporated medical cannabis into their doctor of pharmacy programs and another 23 percent planned to include courses in their programs in the next 12 months.

The University of Maryland School of Pharmacy has launched a new master of science in medical cannabis science and therapeutics, one of the first in the country to do so. The two-year program is designed for an array of healthcare professionals, scientists, regulators, dispensary owners and staff and anyone interested in the field. The program was developed “because of a knowledge gap (in medical cannabis), particularly for healthcare professionals,” said Dr. Leah Sera, assistant professor in the Department of Pharmacy Practice and Science, director of the school’s new master’s program and a clinical pharmacist.

University of the Sciences in Philadelphia has launched a medical cannabis MBA program, specifically targeting the business of cannabis, said Dr. Andrew Peterson, John Wyeth Dean Emeritus and professor of clinical pharmacy and health policy at USciences. Peterson said that the “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise will be incredibly valuable as graduates move forward in their careers.” The USciences courses are provided through the business department in conjunction with the Substance Disorders Institute at USciences and include partnerships with Philadelphia-area cannabis organizations, Peterson said.

Researching the Risks and Benefits

While much of the academic community is focusing on medical marijuana, many questions remain about the impact of the drug and where it fits into pharmaceutical treatment regimens. That’s where the University of Florida College of Pharmacy is jumping in. The university is leading a statewide consortium studying health outcomes related to medical marijuana by evaluating its benefits and risks.

The consortium will tackle safety and effectiveness outcomes but also specific intricacies of medical marijuana inherent in its dosing routes of administration and the effects of smoking versus other methods of consumption, according to Dr. Almut Winterstein, a professor and chair in pharmaceutical outcomes and policy at the University of Florida College of Pharmacy and director of the University of Florida Center for Drug Evaluation and Safety. As the demand grows in the emerging marijuana and cannabis market in Florida, she said there is an “urgent need” for evidence-based studies revolving around medical marijuana. Under the program, the consortium of academic institutions will create a statewide resource for health outcomes research related to medical marijuana, said Winterstein, who was appointed director of the consortium.

As Winterstein sees it, marijuana would be put to the test in the same way as any other drug in development. “As with any other medical treatment, providers, patients and regulators need the necessary information to evaluate its benefits and risks,” she said. “At the time of drug approval, we really don’t know much about side effects and how the new drug works in populations with multiple comorbidities” because that’s not the focus of clinical trials. That’s why post-marketing safety and effectiveness studies are pivotal, and the same applies to medical marijuana. “Really we know very little about what medical marijuana actually does, and for me this requires basically the same systematic evaluation as is in place for any other drug that is on the market.”

While there are similarities with other drugs in studying the impacts of medical marijuana, there is a major difference: for the most part, medical marijuana lacks Food and Drug Administration approval, she noted. As a result, the Florida research “is probably more important because we don’t have approval process on the front end. We really don’t know much about efficacy. And it’s being used by patients who have really serious problems.” If patients who have Parkinson’s disease or multiple sclerosis take medical marijuana, “we don’t know the degree medical cannabis interacts with other drugs necessary to control the disease,” she continued.

While the FDA has not approved marijuana as a safe and effective drug for any indication, it has approved a drug that contains purified cannabidiol, one of the more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years or older. The FDA also has approved drugs containing a synthetic version of a substance in marijuana.

At least 20 marijuana research studies have been initiated in the past five years in Florida, where as many as 200,000 people have been registered to receive medical marijuana, including people suffering from severe and life-threatening health conditions. Researchers have been examining the health benefits and risks of medical marijuana from different perspectives and include outcomes research related to HIV infection, chronic pain in older adults and cannabinol treatment for children with drug-resistant epilepsy.

The university has been involved in a medical marijuana program since 2014. It has extensive research infrastructure and a broad faculty, Winterstein said, and is well positioned to lead the Consortium for Medical Marijuana Clinical Outcomes Research, which comprises public and private universities engaged in research on clinical outcomes of medical marijuana. It will receive $1.5 million in annual recurrent funding from the state to support the research. The university proposes to:

  • Build a repository known as the Medical Marijuana Clinical Outcomes Repository or MEMORY that can track patient outcomes over time.
  • Develop a Clinical Research Core that will provide infrastructure support for studies and establish a competitive grants program offering $600,000 annually from the state appropriation to participating institutions.

The core will assemble a group of physicians and clinical partners to recruit patients for medical marijuana research studies. In addition, the core plans to conduct a survey of medical marijuana providers in Florida, engage a scientific expert group and provide opportunities for the public and industry to help inform the most urgent clinical research priorities, according to the university. The repository will be available to researchers within the consortium and create a statewide resource for real-world health outcomes research related to medical marijuana.

While pharmacy schools are beginning to tap into coursework for medical marijuana, the University of Mississippi School of Pharmacy has been involved in researching the plant for more than 50 years. A 12-acre farm run by the university has been the sole domestic source of cannabis for government-funded and approved research. Through the National Institute on Drug Abuse (NIDA), the University of Mississippi provides marijuana to researchers across the U.S. under NIDA’s Drug Supply Program. After an open competition among institutions around the country, the University of Mississippi won the first contract in spring 1968 to be the government’s provider for marijuana for research purposes.

“During our 50 years of cannabis research we have been involved in a multitude of projects involving the botanical and chemical properties of the plant as well as ongoing development of candidates for new cannabis-based drugs and novel drug delivery systems,” said Don Stanford, assistant director, Research Institute of Pharmaceutical Sciences, which is part of the school of pharmacy. After some legal challenges, the government has now opened the door for more than 30 other organizations to grow cannabis for research, although the process has yet to begin, officials said.

A Complicated Substance

While medical marijuana presents many possibilities, the plant itself is extremely controversial with questions over its legality, overall addictiveness and effectiveness. Marijuana use is legal in some states but it’s still illegal from the federal government’s perspective. About 85 percent of Americans support legalizing medical marijuana.

Because the marijuana plant contains chemicals that scientists say could help a range of illnesses and symptoms, many people argue it should be legal for medical purposes. The major thrust of medical marijuana has been for pain control. Chronic pain impacts millions of Americans.

Marijuana has more than 100 active components. THC, which stands for tetrahyrocannabiniol, is the chemical that ignites the “high” that is linked to marijuana use. CBD, which stands for cannabidiol, is derived from the hemp plant, a “cousin” of the marijuana plant, according to Harvard Medical School. CBD has been used by patients for a variety of conditions, such as pain relief, or to combat anxiety or insomnia. CBD does not have intoxicating properties (although it is also present in the marijuana variety of Cannabis sativa).

The medical cannabis MBA program at University of the Sciences in Philadelphia offers a “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise [that] will be incredibly valuable as graduates move forward in their careers.DR. ANDREW PETERSON

The marijuana plant remains classified as a Schedule I substance under the federal Controlled Substances Act. Schedule I substances are considered to have a high potential for dependency and no accepted medical use, making distribution of marijuana a federal offense. The law, however, is generally applied only when people possess, cultivate or distribute large quantities of cannabis, according to Americans for Safe Access, an organization that advances legal medical marijuana therapeutics and research. The Obama administration encouraged federal officials not to prosecute people who distribute marijuana for medical purposes. The Trump administration differs; it has allowed federal prosecutors to decide how to prioritize enforcement of federal marijuana laws.

Marijuana dispensaries have grown because federal law prohibits cannabis from being prescribed and filled at pharmacies for medical or recreational purposes. State-regulated dispensaries are designated under regulations for the growth and consumption of cannabis, noted Americans for Safe Access.

In Maryland, Strategic Advantage

As the marijuana industry began expanding, University of Maryland officials believed they needed to initiate a program to give students a “competitive advantage” in pursuing a career in the medical cannabis industry, whether working in healthcare or not. Indeed, the program is specifically designed for students with or without a background in science or medicine, said Sera.

The Maryland curriculum includes coursework in “policy and direct patient care,” with a “grounding in the basic science of pharmacology and the development of the formulation and chemistry of different cannabinoids and how we can treat different conditions,” Sera said. For students, the courses also provide a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.”

Faculty for the medical cannabis program include instructors from the pharmacy school immersed in the basic sciences, teaching pharmacology and chemistry, as well as clinicians. Besides those working in the medical field, adjunct professors who are knowledgeable in the study of cannabis will be engaged. Sera herself is a specialist in pain medicine and palliative care.

At least half of the 150 students who were accepted into the program’s first class, which began in August, have a background in science, chemistry, medicine or microbiology. Others include attorneys, educators and patient advocates, and even an art student. The classes are primarily online with an in-person symposium held once each semester.

Neil Leikach, president of a Catonsville-based pharmacy and a BSP graduate of the University of Maryland, is a student in the master’s program and is particularly interested in learning about evolving regulations around cannabis that are impacting pharmacies.

“This has been a Schedule I drug, and states are looking at this differently. There are many opportunities to help patients,” Leikach said. “States are really catching up on how to help patients with different disease states.” Leikach said he’s attended classes that have focused on regulations and drug interactions with cannabis. He’s pleased with the course offerings. “As pharmacists we need more information, and there is not enough good information out there.”

A Matter of Business in Philadelphia

As USciences officials began looking into the academic program for cannabis instruction, they believed that it should examine not only the science of the plants but also something that has not received enough focus: the business of medical marijuana, its marketing and sales. “There are many unique aspects to the medical cannabis and hemp industry,” noted Peterson.

As he examined the program and worked with experts in the field, Peterson said he was surprised by the complexity involved in the underlying business of marijuana and the horticulture process. “I learned so much about the science of growing plants,” he said. “The humidity, pest control, so many things.”

The legal aspect will also be explored. Students will be asked questions such as “what is the status of cannabis as a controlled substance in the U.S. under federal law as well as state to state?” Peterson said. USciences sought assistance in developing its program through a memorandum of understanding agreement with Franklin BioScience, a Colorado-based cannabis grower and retailer. Franklin BioScience assisted in developing educational programs about the cannabis plant and its medicinal value.

Four separate courses are being offered online as part of the Cannabis Industry Masters of Business Administration option under the pharmaceutical and healthcare business curriculum. While any student can take the courses, priority is given to MBA students, and there is no certificate for taking cannabis-related electives, school officials said.

The courses include introduction to the medical cannabis industry; finance and regulation in the medical cannabis industry; cannabis marketing and sales; and a project-based course where students will work to write a business plan or bring a product to market. Currently 14 people are enrolled; officials are still recruiting for the next cohort, all of them MBA students (some of whom are pharmacists). Like Maryland, USciences does not have an on-site cannabis lab.

Symposium attendees in discussion at round tables.
Attendees at the University of Maryland 2019 fall symposium for the MS in Medical Cannabis Science and Therapeutics Program. Photo credit: Matthew Di’Agostino

Mississippi: Ahead of the Field

The University of Mississippi has not offered an advanced degree in medical marijuana despite its research on the substance, officials said. “We could not consider doing so due to our long-standing efforts to develop new cannabis-based therapies as (Food and Drug Administration) approved products, but we are now exploring the possibilities of a cannabis program here,” said Stanford.

From 2005 to 2015, the University of Mississippi was involved in discovering 43 new cannabinoids, which are generally considered the most pharmacologically active compounds in the plant, according to the university. “Our contributions to the understanding of the chemical makeup and biological properties of the Cannabis sativa plant has spanned several decades,” Stanford said. “The longtime use of cannabis for the treatment of glaucoma is another example of how we have been involved in the search for new cannabis therapies.”

Dr. Leah Sera
Photo credit: Matthew Di’Agostino

The University of Maryland’s program provides a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.DR. LEAH SERA

In the early 1970s, studies in both humans and animals indicated that smoking marijuana might provide relief for the intraocular pressure in the eyes, according to Stanford. Taking that a step further, the University of Mississippi conducted studies and provided the standardized cigarettes used in the studies conducted in the U.S. This evidence “led to one of the earliest expanded access programs by the FDA that allow patients access to unapproved treatments,” he said. The university’s research efforts also explored cannabis-based therapies for dry eye, macular degeneration and diabetic retinopathy.

Although the University of Mississippi was the sole contractor with the government for all these years, other researchers are seeking to grow marijuana for contracts now that the process is going to open to more than 30 other organizations and academic institutions. “The University of Mississippi applies for the contract just like everyone else,” said Dr. Mahmoud ElSohly, director of the university’s Marijuana Project and professor of pharmaceutics. “Our research capability, our expertise, our knowledge in the areas of cannabis chemistry and production our personnel and facilities—everything is in place to make us very competitive.” The Drug Enforcement Administration said it “anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes.”

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.BACK TO TOP

For orthopedic surgeons, trying to get paid….can be a pain

From my story at athenaInsight

From the story:

Orthopedic surgery is quite literally a pain for the patient who’s having it, but there’s a major downside for surgeons as well: bad debt. Among all medical specialties, orthopedic surgeons are the most likely to be unable to collect payment from either patients or insurers, especially as deductibles skyrocket. 

In a 2019 report from Medical Group Management Association, data revealed that at least 30 percent of orthopedic surgery practices were in arrears for more than 120 days. The median bad debt is about $48,000 for orthopedic surgeons, compared to $35,000 for other single surgery practices.”  

Many orthopedic practices focused on improving bill collection practices are counting on technology to help them meet their goals. There are a variety of measures physician practices are touting, says Kumrah. Patient cost-estimators can be used based on insurance providers that physicians contract with; they’re helpful because they can seamlessly identify bills for individual patients.  

Process automation robots can take care of the mindless tasks like verifying insurance eligibility and sending out reminders for upfront payments based on schedule. “Healthcare generally is slower to adopt tools/automation as compared to other industries, so it helps to see what’s worked elsewhere from that process and perspective,” Kumrah says.  

“When you have a better-organized system, you are going to have less bad debt,” says Cristy Good, Senior Industry Advisor for Medical Group Management Associate. “You make sure all things are in place: staff training on how to do front-end collections, how to educate patients on their responsibilities, be transparent in your pricing.” 

Thwarting bad debt relies on staying on the cutting edge of health technology, but practices can’t discount the skills of people-to-people conversations. With a little automation and ingenuity, orthopedic surgery doesn’t have to be as painful for anyone involved. — Joe Cantlupe, HealthDataBuzz

Quid Pro Quo: A Part of Nature: Even for Rats

Quid Pro Quo — I’ll do something for you, if you do something for me — isn’t restricted to, well, politics.

Ok, it’s not even restricted to humans or other primates.

Rats do it too.

In exchange for food, rats will “groom” another rat’s hair, sometimes repeatedly in what scientists say is a cooperative behavior similar to humans. Researchers at the University of St. Andrew in Scotland found that rats were more inclined to engage in grooming with a fellow rat when food was received from it than not, and vice versa.

While many different animals show reciprocity for like commodities, such as food for food, primates have been known to be capable of trading goods, i.e. food, for other services, such as sex, for instance, in the case of chimpanzees. Trading of different commodities is considered a fundamental component of human interactions, with quid pro quo a part of our being and how we get along.

The fact that rats do it too indicates that it may be more widespread in nature than originally believed, and the reciprocal trading may not be limited to large-brained species with advanced cognitive abilities.

“The prevalence of reciprocal cooperation in non-human animals is hotly debated,” said Dr. Manon Schweinfurth of the School of Psychology and Neuroscience at the University of St. Andrew in Scotland, co-author of a study on rat behavior. “Our study suggests that either rats have this concept or reciprocity is cognitively less demanding than previously thought.”

She and Professor Michael Taborsky of the Institute of Ecology and Evolution at the University of Bern published a paper ‘Reciprocal Trading of Different Commodities in Norway Rats. on the subject earlier this year in Current Biology.

Quid Pro Quo

For humans, giving something in exchange for something else is a part of interactions with others and starts at a young age. “A key feature of human interactions is the quid pro quo: you do something for me and in exchange I do something for you and in exchange I do something for you,” Jonaton D. Crystal, Department of Psychology and Brain Sciences, Indiana University wrote about the study as a Quid Pro Quo in the journal Current Biology.

“Children 3 years onward reliably reciprocate with each other,” Schweinfurth says. “Kids most likely don’t have to learn reciprocity either but their brain is not fully developed and they lack capabilities that enable them to reciprocate.” “

Quid pro quo has been in the news constantly the last few months — maybe more so than at any time in recent memory — as investigators examine President Trump’s actions in allegedly withholding funds for Ukraine unless that government investigated former Vice President Joe Biden’s son, who conducted business there. ( The Democrats began steering the party’s narrative away from quid pro quo but a more directed allegation of “bribery.”

While quid pro quo is especially the topic of debate for political humans, some scientists believe that the action of reciprocity is definitely human, but others say the practice is not unique to us.

“The prevalence of reciprocal cooperation in non-human animals is hotly debated,” Schweinfurth writes. “Part of this dispute rests on the assumption that reciprocity means paying like with like. However, exchanges between social partners may involve different commodities and services.”

Many animals help each other such as bees managing hives seeking other bees’ assistance. And several species, particularly among primates, such as monkeys, have been known to apply such rules when exchanging food for other actions, such as protection, Schweinfurth says. Primates have been known — through observational evidence — to trade different services, such as chimpanzees trading grooming for meat.

Rats Do It

But rodents, such as rats? Indeed. Her studies show that “rats seem to follow reciprocal rules like tit-for-tat to help each other,” Schweinfurth said. Of rats, “they likely don’t memorize exact donation rates or calculate that was received but form attitudes toward their partner…like partner A was nice to me,” she added.

Rats live in burrows and form mixed social groups that might involve as many as 200 individual rats, which frequently interact with each other. As highly social animals, they often huddle together to keep warm, share food and have been known to softly pat each other’s hair.

“Rats are good model organisms because you can keep them in the lab and they learn quickly how to use experimental setup. We worked not with the classical lab rat but with descendants of wild rats,” the species known as Norway rats, Schweinfurth said.

In a series of experiments, food — oat flakes — were put into a moveable platform and rats pulled it toward other “partner” rats. The rats, which were closely studied, known as focal rats, pulled a stick connected to the moveable platform in a cage and provided food to the partner, which then in turn softly patted or groomed them. Each cage held two rats, each in its own little compartment. By pulling the connected stick, the platform moved into the cage and provided food only to the partner rat.

In an examination of more than 30 rats, the so-called focal rat continually provided more food to grooming partners than not. Rats provided more food to “cooperative” partners in test conditions, which were not previously achieved, Schweinfurth said.

The grooming occurred after saltwater was applied to the neck of the focal rat to create a situation where help was needed. Each rat’s “propensity to help the partner remove the unpleasant saltwater is enhanced by the previously experienced food donations of the partner,” the researchers wrote. “Grooming is a widespread behavior and the results might hence be more generalized to other species,” Schweinfurth said. After the experiment, the researchers took rats out into a large container where they could groom each other.

“Hitherto there is no experimental evidence that animals other than primates exchange different commodities among conspecifics based on the rules of direct reciprocity,” the researchers added in the study. “Here we show that Norway rats apply direct reciprocity rules when exchanging two different social services: food provisioning and (grooming.)

Rats — Lots of Them

Schweinfurth said she has been studying rats since 2013, calling them “fascinating animals.”

“They are highly intelligent and billions live with us, but we really don’t know much about them,” she says. “We have a very different and interesting relationship with rats. They are very useful to us as lab rats. We hate them when we encounter them in the cities and we love them as pets.”

“There is some evidence (from another study) that rats anticipate reciprocity in the future,” she says. “If rats are hungry, they are more likely to invest in donating food to others, probably in the hope of getting more back.”

Despite the give and take, Schweinfurth said she has been restarted in her studies that she couldn’t find a “friendship” among rats.

“For the rats, they work on not an accumulative experience with a partner,” she says. “They respond to the last experience. Basically, they only consider “what have you done for me lately.”

In her recent work, Schweinfurth has moved beyond rats — to humans and other primates.

She said she wanted to “compare rats to understand how unique our form of reciprocity is and whether different species have found different ways to cooperate with each other.”

And much of that cooperation begins with the quid pro quo. – Joe Cantlupe, HealthDataBuzz

(Photo: Rats “grooming.”Courtesy of Dr. Manon Schweinfurth)

A Road to Bicycle Safety: NTSB Says “Critical Changes” Needed To Reduce Motorists’ Collisions With Cycles

Intersections, intersections.

That’s where 65 percent of bicycle and motor vehicle collisions occur.

And too many cars try to overtake bicyclists on the roads — incidents responsible for least 25 percent of fatal crashes. In many of those cases, the motorists didn’t see the cyclists.

Those are among the findings cited in the National Transportation Safety Board‘s first examination of bicyclist safety in 47 years. The board said today “critical changes” are needed to address an increase of bicycle crashes involving motor vehicles.

Among the proposals:

Improve roadway design.

Enhance visibility of bicyclists

Tap into the latest technology

Increase helmet use.

Such plans “hold the most promise for reducing the number of fatal and serious crashes,” the NTSB said.

“If we do not improve roadway infrastructure for bicyclists, more preventable crashes will happen and more cyclists will die in those preventable crashes, ” said NTSB Chairman Robert L. Sumwalt. “If we do not enhance bicyclist conspicuity, more bicyclists will die in preventable crashes.  If we do not act to mitigate head injury for more bicyclists, additional bicyclists will die.”


Photo, taken Aug. 16, 2019, in Washington, a two-way separated bike lane with vertical barrier is shown. NTSB photo by Ivan Cheung.)

NTSB investigators said “25 percent of all fatal collisions involving bicyclists – the most frequent type – occurred while a motorist was overtaking a bicyclist in the stretches of roadway between intersections.”

At intersections, said fixes should include clearly denoted “right-of-way using color, signage, medians, signals and pavement markings would likely reduce the number of crashes in those environments,” the NTSB said.

Investigators said “about a third of the motorists involved in fatal crashes while overtaking a bicyclist did not see the bicyclist prior to the collision. “

The NTSB safety report will be available in several weeks, officials said. A text of the findings and safety recommendations, is available at — Joe Cantlupe, HealthDataBuzz