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Join us as we explore the history and evolution of the orphan drug revolution with James Geraghty, a health care executive. Discover how the pharmaceutical industry of the 1970s, driven by a pursuit of predictable profitability, led …
An inside look at the orphan drug revolution [PODCAST]
The United States and Canada started a movement that began as medical cannabis and quickly exploded into adult-use cannabis markets. However, the North American operators failed to properly regulate the processes from growing to manufacturing to compete in a global pharmaceutical-level market. Europe has taken the lead as the heavy-weight producer of truly medical-grade pharmaceutical cannabis flowers and products. Notably, many operators in the U.S. and Canada claim to produce …
Why North American medical cannabis can’t compete globally
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In this episode, we welcome Cindy Perlin, a licensed clinical social worker and chronic pain survivor, to discuss the ongoing issue of prescription painkiller abuse and the dangers of relying on medication to treat pain. Research shows …
Pain management beyond prescription pills [PODCAST]
Psychosis is a broad term that describes a change in the perception of reality. It can be caused by various conditions, including metabolic, psychiatric, neurologic, genetic, and other medical conditions, as well as licit and illicit substances, particularly cannabis. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) states that abnormalities define these disorders in one or more of the following five domains: delusions, hallucinations, disorganized thinking (speech), …
The dark side of cannabis: increased risk of psychosis
Driving around, searching for children’s Tylenol and a pharmacy that had the antibiotics my son needed, was not how I wanted to spend the holidays. I am not alone – shelves are bare, and antibiotics are in short supply as we head into the new year in the midst of a triple threat of COVID-19, flu, and RSV.
While this drug shortage is incredibly frustrating, at least there is …
Timely treatment decisions: the promise of surrogate markers
An excerpt from Inside The Orphan Drug Revolution: The Promise of Patient-Centered Biotechnology.
Pre-revolutionary stirrings
Every revolution rises up against an order in need of reform. For the orphan drug revolution, that order was the pharmaceutical industry of the 1970s. Most pharma companies had been founded by entrepreneurial chemists or pharmacists decades …
The promise of patient-centered biotechnology
Less than a year ago, a position paper/meta-analysis was published whose authors concluded that the pain reliever acetaminophen, and products containing this compound, were contraindicated in pregnancy as they could result in premature or stillborn births or developmental defects. Earlier studies appeared more positive and resulted in recommendations for its use by professional and governmental organizations. The present authors acknowledged this disjunction and made both the routine recommendations for further …
A rush to judgment on acetaminophen?
Everyone knows the terrible toll the opioid epidemic takes on our society. It doesn’t matter where you live and how wealthy or educated you are, no one is immune. I watched as a colleague tried to help a child struggling with addiction, spending countless hours of worry and thousands of dollars, only to have the child succumb to an accidental opioid overdose. The emotional and financial cost on individuals and …
Think twice before prescribing opioids as a first-line treatment for pain
The American Cancer Society released its annual report on cancer statistics, showing that we have made clear and significant progress in treating numerous forms of cancer. The overall rate of death has declined steadily since 1991, translating to over 3 million lives saved.
Despite this progress, I still see room for improvement in a care model where patients too often slip through the cracks.
The National Cancer Institute identified that …
Integrated care is the key to optimizing cancer outcomes
You’ve been swallowing things your entire life: breast milk (or formula), food––maybe a marble or small Lego. But did you know that swallowing pills is different?
Let’s start with how not to swallow a pill.
Sorry, but Bruce Willis in all five Die Hard movies is incorrect. You don’t just take a small handful of aspirin, toss them into your mouth, and jerk your head back while swallowing.
Not to mention, if you have …
I wondered whether to recommend Nuedexta for my elderly relative with worsening Alzheimer’s disease and daily spontaneous crying. Often she would deny feeling sad and couldn’t account for her sobbing. Avanir Pharmaceuticals released Nuedexta in 2010 to treat pseudobulbar affect: involuntary emotional outbursts due to certain neurologic conditions or brain injury. I wasn’t sure if these crying bouts qualified as pseudobulbar affect. But my biggest hesitation was the breathtaking …
How drug prices are manipulated
“By God’s grace, Dr. Sal!”
“Yes, T.J.! What’s the good news?”
“Guess what Mr. Thompson’s potassium is now?”
“3.1 …”
“Wrong! 4.1!”
We high-fived each other immediately and breathed a huge sigh of relief. For six days straight, we’ve been giving Mr. T potassium through an IV and by mouth with little to no change in his potassium level.
He came to the hospital after being found passed out in his home. Very low initial blood …
A friendly battle with a patient’s potassium
Medical care in the United States is broken. The pandemic contributed, but we were well along this misdirected journey. There is a pathological push/pull between financial pressures applied by payors and health care systems to decrease costs, thereby generating profits versus the desire of providers to deliver outstanding care to patients. This is ingrained into our system as it is designed. The dynamic is further muddled by our unique medicolegal …
Management of acute postoperative pain reveals systemic flaws in health care policy
While cancer has been around for decades, the fight for survival and treatment options are still very top of mind. Treatment is simply playing catch up. We continue to try and get rid of the disease that has already infiltrated one’s body rather than catching it before it develops. We need to shift the focus from therapeutics that fight the disease to ways we can catch it before the deterioration …
Cancer of the future: diagnosis, treatment, and impact on the health care system and patients
In the last two years, pharmaceutical companies have become increasingly interested in the possibilities in silico technologies bring to the world’s multi-billion-dollar drug development market. Among the factors that have been reported as drivers of recent interest in what is also known as virtual clinical trials are the COVID-19-related restrictions that began impacting traditional human-based clinical trials in 2020.
In silico drug development utilizes real-world data (RWD), artificial intelligence (AI), computational …
The promise of in silico drug development to improve patient outcomes
Health care has fooled us into believing a number of myths that—taken at face value—sound logical and true. Here’s one of the most pervasive and dangerous myths: Pharmacy’s value comes from convenience and access. And here’s another one: 90-day fills, and automatic refills on prescriptions improve medication adherence and patient health.
It’s not surprising that people might champion the efficacy of these tactics. It feels easier to get 90 days of …
Automatic refill and 90-day fill programs don’t improve medication adherence
Minority and marginalized communities have historically been underrepresented in local and federal governments and in dozens of private sectors globally. Pharma is no different; there exists a steep chasm that drugmakers have yet to bridge concerning research and trials. The longer this gulf exists, the harder it becomes to address – the feelings of mistrust, resentment, and disenfranchisement only get harder to overcome with time.
Over the last decade, the pharmaceutical …
A path toward clinical trial diversity
FDA and Health Canada recently approved Paxlovid as an oral treatment option for mild-to-moderate COVID-19 who are at high risk of progression to severe COVID-19. It is a combination drug containing nirmatrelvir/ritonavir. Nirmatrelvir works by binding to SARS-CoV-2 3CL protease to ultimately stop viral replication. Ritonavir does not have any antiviral activity against COVID-19 but increases concentrations of nirmatrelvir by decreasing its metabolism by CYP3A4 enzyme. Ritonavir is …
Before taking Paxlovid, consider these drug interactions
My credit card hovered over the card reader at the pharmacy as I contemplated whether I should pay. Two hundred and eighty dollars and some change. For two EpiPens, each with 0.3 mg of epinephrine that could potentially save my life if I accidentally ate something with sesame seeds. At that moment, I realized that even I, as someone with good employer-based family health insurance, was being forced to make …
Will Biden’s State of the Union remarks revive prescription drug reform?
I love generic brand products. I will fight to the last breath for my Shoppers’ Choice Adhesive Bandages rather than pay an extra $0.49 for Band-Aids. So why, then, have I been paying up to $395 every month for brand-name medication for the last two years instead of getting the generic version for $7.56? After all, aren’t generic drugs the same as their brand-name counterparts?
Let’s go back to November 2019, …
Concerns about the generic formulations of ADHD medications
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