Brad Hightower

Conventional wisdom about evaluating the medical literature: - A statistically significant result means that a treatment is beneficial - Surrogate outcomes are valid predictors of clinical outcomes - Results of RCTs can be replicated in non-RCT settings - RCTs provide ‘better’ evidence than observational studies - Larger sample sizes produce more robust results What clinicians and healthcare decision makers should know: - Statistically significant results don’t always translate into clinically meaningful benefits - Studies should report results in terms of clinical outcomes - Often results of RCTs are not replicated in routine practice settings - RCTs and observational studies both provide valuable information - Larger sample sizes could potentially distort study findings Critically appraising the medical literature isn't about p-values and study hierarchies. It's about approaching studies with a healthy scepticism. Using a repeatable system. #evidencebasedmedicine #healthpolicy #rwe

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DEA, the US drug control agency, will move to reclassify marijuana in a historic shift, Associated Press sources say. If AP is accurate, this landmark decision will spark medical research, as it will reduce current barriers imposed on Schedule 1 substances. The decision by the DEA to move marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA) is indeed a significant one that will benefit medical doctors and scientists who wish to conduct cannabis research. This change acknowledges the medical uses of cannabis and recognizes that it has less potential for abuse compared to drugs classified under Schedules I and II. Here are some of the benefits this decision is expected to bring for medical research and healthcare professionals: • Easier Research: Rescheduling marijuana to Schedule III will make it easier for scientists to conduct authorized clinical studies, as the current barriers imposed on Schedule I substances will be reduced • Tax Benefits: Cannabis businesses can take federal tax deductions previously barred under the IRS code 280E, which could indirectly support research funding and development. • Medical Use: Thousands of healthcare professionals are authorized to recommend medical marijuana, indicating its acceptance in parts of the medical community. This rescheduling could further legitimize and expand its medical use. • Public Health: The federal health review concluded that the risks to public health posed by marijuana are low compared to other drugs of abuse, which could lead to a more balanced approach in its regulation and research While this decision does not legalize marijuana, it represents a shift in federal policy that aligns with the current scientific understanding of cannabis and its potential therapeutic benefits. It's a step forward for the medical community and could pave the way for more comprehensive research into the medical applications of marijuana. Further steps include a review by the White House Office of Management and Budget (OMB) and a public comment period before the rule can be finalized. Link to AP article in comments below Please support our community content by liking and commenting on this post. Please follow me on Instagrm: drsandracarrillo for unique content not posted to Linkedin. Twittr: md_carrillo Medicannips IPS Medical Cannabis Clinics, Colombia. https://lnkd.in/guCTjCMM #cannabis #marijuana #medicalcannabis #cannabisscience #medicine  #thc #cbd  #education #Health 

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A recent warning letter for a Clinical Investigator: "As a clinical investigator, when handling an investigational drug that is subject to the Controlled Substances Act, you are required to take adequate precautions to prevent theft or diversion of the controlled substance into illegal channels of distribution. These precautions include the storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited. In addition, as a clinical investigator, you are required to ensure that your clinical studies are conducted in accordance with the investigational plan. The investigational plan for Protocol (b)(4) required you to ensure that all clinical drug supplies were stored in a secured, monitored, and limited-access area, in accordance with labeled storage conditions. Additionally, the protocol required the clinical investigator to limit access to the study drug to the named subinvestigators, or to other appropriately designated study personnel or monitoring personnel." Do you work with controlled substances? If you do, you may want to review this warning letter and evaluate your protocols, processes, and facilities!

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How can we lower rising healthcare costs in America?

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Because oncology studies generally don’t enroll huge amounts of patients (hundreds compared to thousands in cardiology) and many don’t have long term follow up, getting signals about toxicities can be a challenge We often learn about toxicities after a drug is approved when it starts being used in large numbers of patients That’s why the updated safety analysis of the CROWN trial caught my attention. This 5 year update of lorlatinib vs crizotinib in ALK+ lung cancer was presented at ASCO this year and skillfully summarized at a recent oncology pharmacy event by Kevin Chen. For background, CROWN was a phase 3 open label study in newly diagnosed ALK+ non-small cell lung cancer. Patients were randomized to either lorlatinib or crizotinib and the primary outcome was progression-free survival (PFS). Lorlatinib showed impressive results with a median PFS that hasn’t been reached yet compared to 9.1 months with crizotinib 😳 Unfortunately, lorlatinib is not a fun drug to take. About 2/3 of patients had a grade 3/4 adverse event, although only 5% discontinued therapy due to them, which is surprising Changes in cholesterol were the highest incidence, and they are difficult to treat - you’ll have to dust off those primary care skills if you’re managing these patients 😅 The weight gain seen is impressive. Think about your weight and what a 20% or more gain would do - you would need a whole new wardrobe Very concerning for patients are the mood, cognitive, and psychotic effects Here are some examples of real patient reports from Kevin’s practice: 👉 A patient seeing ants crawling on the wall 👉 A young mother forgetting to pack her kids lunches a few times a week 👉 A patient’s spouse sharing privately with team that the patient’s mood changes have become problematic Take a look at your clinic and identify which patients are on lorlatinib and how they are tolerating it. I bet there are interventions you can make to improve their quality of life. --- 📌 When you’re ready to prioritize learning oncology, the Enjoy Learning Oncology (ELO) program can help you! Check out the LEARN ONCOLOGY link in my profile. I’m the Kelley in KelleyCPharmD 👋 and I help pharmacists learn the complex world of oncology #LearnOncology #Pharmacists #OncologyPharmacists #ClinicalPearls #Oncology

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From USPSTF today: "The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of supplemental screening for breast cancer using breast ultrasonography or magnetic resonance imaging (MRI) in women identified to have dense breasts on an otherwise negative screening mammogram." I don't think so! See the image and see how #breastcancer is missed using mammography alone in woman with dense breasts. 50% of women have dense breasts. 71% of breast cancer patients have dense breasts. Time for change! We need #advocacy for Find It Early Act NOW! Call or email your Member of Congress: www.House.gov and www.Senate.gov -- you can put in your zip code and find out who your Rep. is then click on their website and leave a message about the importance of ALL women having access to supplemental screening. Advocacy works! Your voice matters! My Density Matters Brem Foundation to Defeat Breast Cancer The Breast Cancer Research Foundation Living Beyond Breast Cancer Breast Cancer Awareness Month American Cancer Society HealthyWomen Women's Health Access Matters Black Women's Health Imperative American Medical Women's Association (AMWA) American Medical Association American College of Radiology Society of Nuclear Medicine and Molecular Imaging (SNMMI)

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Should MRD negativity be accepted as a surrogate endpoint for clinical trials in myeloma - Ben Derman https://lnkd.in/gaYMuZkh #oncodaily #oncology #cancer #MRD #myeloma #clinicaltrials #FDA #surrogateendpoint #OverallSurvival #PFS #mmsm #mmMRD

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Did you know that Technology in Cancer Research & Treatment is an Open Access journal that offers tiered APC pricing for different article types? Brief Report- 20% discount Research Note- 20% discount Technical Note 20% discount Mini Review- 30% discount Commentary- 30% discount No APC for Editorials and Letters to the Editor Read more here about the journal’s article types and about other types of APC discounts 👇 https://lnkd.in/gYtrXN5v #openaccess OncoDaily #medphys #radonc #artificialintelligence #medicalimaging #immunotherapy #radiotherapy #biomarker #radiosurgery #cancerresearch

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Continuing medical education (CME) trends (2) Certainly, healthcare professionals (HCPs) are too busy to catch up with the newest info on drugs and guidelines. What’s more, there’s a ton of information, expanding at probably an exponential rate, out there for them to learn. So I’ve been wondering how CME can serve better to educate HCPs and help patients regarding this challenge. One of the trends says that we need to tailor the educational content according to individual needs to overcome this challenge. So does it mean that when a certain medical problem is encountered, the HCPs and patients can access the necessary info as quickly as possible? Then how do CME companies create tailored content for each individual? Then the word “chat” appeared in my head. And actually, I have been helping with a project of chatbot through #medicaltranslation. Indeed, omnichannel Communication is a Driving Force for CME growth.[1] What is omnichannel? Omnichannel communication means to use multiple channels for healthcare professionals to access critical information seamlessly across multiple formats, and thus improve education efficiency.[1], [2] Examples of omnichannels for CME include:[2]  🤖 - Artificial intelligence chatbots  📞💻 - Video & Voice Assistants 💬📱 - Messaging Channels such as WhatsApp, SMS & Facebook Does your work involve building/using any of these omnichannels? What challenges do you encounter? Hello I'm Ri, a dedicated freelance medical writer specializing in medical communications. Contact me for your upcoming projects! #MedicalWriting #healthwriting #medicalcommunications #medicalillustration #MedicalTranslator

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Calling all #biocoordinators #accesscoordinators #patientadvocates #reimbursementmanagers #arm #frm #fas #fras : What is everyone doing for their #PriorityHealth patients that were enrolled in #SaveOnSP who are now being discontinued as of June 1, 2024?!?! Those patients copay card funds have already been #EXHAUSTED as they had a #maximizer plan so will need to submit for #patientassistance and many may not qualify due to exceeding income requirements. What about offices that don’t have a dedicated point of contact? This is outrageous, should be illegal as they’ve taken all the copay card money up front (correct me if I am wrong) and is going to affect patients #access to therapy and putting patients at risk of #lapse in therapy and #discontinuation. My thought process as I was #brainstorming this issue is: -Contact reps to get #samples -Update VM asking pts affected by this to leave their name, DOB, name of drug and when they’re due for their next dose to triage who needs a sample first -Direct patients to manufacturer patient assistance foundations website to initiate the #PAP application ASAP -Create a checklist of what patients need to provide for their patient assistance application, especially if they want to do a paper application and have office submit -Say a prayer and hope for the best Any other suggestions?! #navigatingaccessissues #howisthislegal #michigan #thisisNOTok

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I’m thankful that I could share my thoughts at that very hearing. There is so much misinformation about 340B. For me, it comes down to two main points: 1- if hospitals need that money as a subsidy to fund everyday activities, they should just ask for a subsidy. Let’s open up the books of these institutions, which already get a huge subsidy with their non-profit status, and see why they are running in the red. Are they really losing money on Medicaid patients or are they just bloated and inefficient? 2- let the subsidy follow the patient. This is a drug benefit program. Why does the funding go to an institution? Imagine if we did that with SNAP, giving a bunch of money to large restaurant chains in exchange for their promise to use the revenue to provide food for poor people (with no oversight to ensure that’s done). We don’t do that; instead we give the benefit to the person who needs it. Let’s change 340B to match that model. Adam J. Bruggeman, MD, MHA, FAAOS, FAOA Daniel Choi Colin Yokanovich John Strom Peter Stein Adam Fein Deborah Williams Lisa Grabert Maya Babu, MD, MBA Katie Orrico Larry Bucshon, M.D. Ann M. Richardson, MBA

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Exciting to learn how the CRDSA standard will enable the conduct of good science and promote responsible secondary research use!

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Excited to see this article published by Chad Worz, PharmD, BCGP, FASCP It’s free to read for 90 days! Check it out now to gain critical insights into long-term care for older people!

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The 25 most popular (or priciest/popular?) #prescriptiondrugs in the US: This was recently published by Beckers: https://lnkd.in/gBpHgQkv Just for fun, I analyzed to see what drugs, if any, are actually acquired over at the pharmacy vs. billed in the medical benefit. Spoiler alert - many of them are billed in the MEDICAL benefit, NOT picked up at your local retail pharmacy. (And to my pharmacist colleagues out there - yes, most if not all of these can be billed under either benefit, but I marked where they're typically billed...). Next, I looked to see which we had available at teamcubancard.com. Self-funded employers - you can save a ton of money for your plan by allowing patients or employees to move to biosimilars to adalimumab below (#2). We're striving to add more drugs and biologicals every day at Mark Cuban Cost Plus Drug Company, PBC! #pharmacy

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Watch this video to review options for enrolling patients in the NRG-GU009 (PREDICT-RT trial) and the NRG-GU010 (GUIDANCE) phase III RCTs, which both require risk stratification using Veracyte, Inc.'s #DecipherProstate Genomic Classifier. 

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See how PRIMR is helping Decipher by Veracyte build educational content for providers and patients enrolling on the NRG ONCOLOGY #prostatecancer #clinicaltrials Make your clinical trial easy to understand with PRIMR: https://lnkd.in/e6zPbmG3

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Shifting Your Mindset for Success w/ Dr. Lorneka Joseph PharmD on #TWIRx This Week in Pharmacy, we're discussing the Summer Solstice, the Longest Day of the Year occurring when one of Earth's poles is tilted toward the sun at its most extreme angle, and due to Earth's tilt, this happens twice a year. Thanks to RxMile for sponsoring today's TWIRx, logistics strategies and technology, this software sells itself. With the expansion of long term care at home, and the need for more pharmacy delivery in areas with pharmacy closures, it's time to talk with Kunal Vyas and his team. This is a game changer. NEWS: The The New York Times reported on the impact to public health of the PBMs middlemen, causing massive struggles for pharmacy care throughout the nation. Pharmacy closures in Michigan and Ohio causing major concerns for the needs of millions of people. Maternal Health Disparities, Role of Pharmacists in Improving Outcomes, from Pharmacy Times, interview with Rebbeca Snead, PharmD. Listen here: https://lnkd.in/ecfQ6Xd7 Apple: https://lnkd.in/ecfQ6Xd7 Spotify: https://lnkd.in/e48rM2iX

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Studies of analgesic use postoperatively should consider the lateness/ earliness of medication administration times for scheduled (i.e., not "as needed") drugs. Fewer than half of doses (46%, P <0.0001) were administered ±30 minutes of the due time. 95% of doses administered over a 4.8-hour window, from 108 minutes early (97.5% one-sided upper confidence limit 105 minutes early) to 181 minutes late (97.5% one-sided lower limit 179 minutes late). https://lnkd.in/gv-9xgAz

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