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Tag: FDA

Zap Away

BY KIM BELLARD

Speaking as a sometimes forgetful “senior citizen,” when I found out that non-invasively zapping brains with electricity can result in measurable improvements in memory, that’s something I’m going to remember.

I hope.  

In research published in Nature Neuroscience by Grover, et. al., a team lead by Boston University cognitive neuroscientist Robert Reinhart produced improvements in both long-term and short-term (working) memory through a series of weak electric stimulation – transcranial alternating current stimulation (tACS). The authors modestly claim: “Together, these findings suggest that memory function can be selectively and sustainably improved in older adults through modulation of functionally specific brain rhythms.”

The study provided the stimulation using something that looks like a swimming cap with electrodes, applied for twenty minutes a day for four days.  The population was 150 people, broken up into three separate experiments, all ages 65 to 88.

The results were amazing.  “We can watch the memory improvements accumulate … with each passing day,” Dr. Reinhart marveled.  

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Pharmacists Can Now Prescribe Paxlovid. Good idea?

BY ANISH KOKA

Apparently, the US Food and Drug Administration (FDA), that has long been charged with the safety and efficacy of drugs and devices now also controls who can prescribe drugs.

I was under the mistaken impression that in our highly rule based society you would need to pass a law to allow that to happen. Passing laws , of course, can be a long, messy, process that involves having to convince constituencies, and ruling by executive order is just way more efficient apparently.

So by decree of the FDA patients can now get Paxlovid, an anti-viral for the virus that causes COVID19, “directly from their state licensed pharmacist” if they so choose. Apparently, someone in government decided that there wasn’t enough Paxlovid being prescribed, and the major rate limiting step for many patients is not having access to a provider to prescribe the drug. I have to say provider now because physicians long ago lost the monopoly they enjoyed for prescribing medications to nurses with advanced degrees and physician assistants. The next obvious step is to cut out the ‘clinicians’ completely by allowing patients to get medications from a pharmacist without a prescription.

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Lou Lasagna and the MIC “Integrated Career Ladder” – More Than Just A “Revolving Door.”

BY MIKE MAGEE

The New York Times recently shined a light on the FDA’s top science regulator of the tobacco industry, Matt Holman, who announced his retirement after 20 years to join Phillip Morris. As they noted, “To critics, Dr. Holman’s move is a particularly concerning example of the ‘revolving door’ between federal officials and the industries they regulate…”

As a Medical Historian, I’ve never been a fan of the casual “revolving door” metaphor because it doesn’t quite capture the highly structured and deliberate attempts of a variety of academic medical scientists over a number of decades in the 2nd half of the 20th century to establish and reward an “integrated career ladder” that connected academic medicine, industry and the government. 

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The FDA’s Culture: Should Safety Dominate All Practices?

By STEVEN ZECOLA

An organization’s culture is an internal set of shared values, attitudes and practices. The cohesiveness of the organizational culture will affect whether the entity will meet its vision, purpose, and goals.

One type of organizational culture is hierarchical in nature.   Unlike a risk-taking culture, this structure features policy, process and precision. It is best suited for mature and stable organizations.

The disadvantage of a hierarchal culture is that its stability and control can turn into rigidity. In many cases, the organization develops a negative attitude towards ideas supplied by third parties. It paints itself as having the perfect answer for every issue, no matter how large or small.

My interactions with the FDA suggest that its cultural practices are focused on safety, seemingly to the exclusion of all other issues.  This practice may be appropriate in the regulation of food, but not for drug research where flexibility and creativity are required to cure complex diseases.

Over the past decade, I have witnessed an excessive adherence to its existing practices in the context of BRCA1-related breast cancer, metastatic cancer, precision medicines, “Big Data” and Parkinson’s disease. While the rulings were directed at me, the FDA’s position on these issues has impacted millions of people for the worse.

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Pandemic Fears: What the AIDS Battle Should Teach Us About COVID-19

By ANISH KOKA, MD

As the globe faces a novel, highly transmissible, lethal virus, I am most struck by a medicine cabinet that is embarrassingly empty for doctors in this battle.  This means much of the debate centers on mitigation of spread of the virus.  Tempers flare over discussions on travel bans, social distancing, and self quarantines, yet the inescapable fact remains that the medical community can do little more than support the varying fractions of patients who progress from mild to severe and life threatening disease.  This isn’t meant to minimize the massive efforts brought to bear to keep patients alive by health care workers but those massive efforts to support failing organs in the severely ill are in large part because we lack any effective therapy to combat the virus.  It is akin to taking care of patients with bacterial infections in an era before antibiotics, or HIV/AIDS in an era before anti-retroviral therapy.  

It should be a familiar feeling for at least one of the leading physicians charged with managing the current crisis – Dr. Anthony Fauci.  Dr. Fauci started as an immunologist at the NIH in the 1960s and quickly made breakthroughs in previously fatal diseases marked by an overactive immune response.  Strange reports of a new disease that was sweeping through the gay community in the early 1980’s caused him to shift focus to join the great battle against the AIDS epidemic. 

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The FDA Needs to Set Standards for Using Artificial Intelligence in Drug Development

By CHARLES K. FISHER, PhD

Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many consumer devices. In less than a decade, machine learning algorithms based on deep neural networks evolved from recognizing cats in videos to enabling your smartphone to perform real-time translation between 27 different languages. This progress has sparked the use of AI in drug discovery and development.

Artificial intelligence can improve efficiency and outcomes in drug development across therapeutic areas. For example, companies are developing AI technologies that hold the promise of preventing serious adverse events in clinical trials by identifying high-risk individuals before they enroll. Clinical trials could be made more efficient by using artificial intelligence to incorporate other data sources, such as historical control arms or real-world data. AI technologies could also be used to magnify therapeutic responses by identifying biomarkers that enable precise targeting of patient subpopulations in complex indications.

Innovation in each of these areas would provide substantial benefits to those who volunteer to take part in trials, not to mention downstream benefits to the ultimate users of new medicines.

Misapplication of these technologies, however, can have unintended harmful consequences. To see how a good idea can turn bad, just look at what’s happened with social media since the rise of algorithms. Misinformation spreads faster than the truth, and our leaders are scrambling to protect our political systems.

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Why Former FDA Commissioner, Scott Gottlieb, Joined the Aetion Board | Carolyn Magil, CEO Aetion

By JESSICA DAMASSA, WTF HEALTH

Big news from Aetion CEO, Carolyn Magil, as she talks about the addition of former FDA Commissioner, Scott Gottlieb, to her Board. WHOA. What a HUGE endorsement of support for what Aetion is building…which is what, exactly? Carolyn explains how the company is using real world data (any data outside of clinical trial data) to figure out how different people will react to the same drug. That means they’re using data from health insurance claims, EMRs, wearables, pharma registries, etc. to ultimately save the time, money, and headache of finding out which medicines will work best for which patients. What’s more? A priority for Aetion is helping bring to light how populations usually under-represented in clinical trials (women, seniors, kids) will react to certain treatments. Backed by $77M in funding, and now the former FDA head, tune in to find out what’s next for Aetion.

Filmed at the HIMSS Health 2.0 Conference in Santa Clara, CA in September 2019.

The Untold Reality of Medical Device Shortages in the U.S.

Chaun Powell
Soumi Saha

By CHAUN POWELL, MBA and SOUMI SAHA, PharmD, JD

Say the word “shortage” to a healthcare professional and chances are the first thing that will come to mind is drug shortages. With good reason, too – there are more than 100 drugs currently at risk or not readily available for U.S. hospitals, according to the Food and Drug Administration’s (FDA) drug shortage list. 

Shortages don’t just apply to drugs, however, and as 2019 has shown, healthcare providers must become more focused on shortages of the medical device variety. The shutdown of multiple medical device sterilization facilities in 2019 is poised to jeopardize the availability of devices that are critical to routine patient care. On Nov. 6, the FDA is hosting a panel to hear from stakeholders, including hospital epidemiologists and healthcare supply chain experts, on the risks associated with facility shutdowns and potential action steps.

The industry as a whole is in need of meaningful solutions. As taxpayers, patients and key stakeholders in healthcare, we must collaborate to eliminate interruptions to our healthcare supply chain. For those invested in improving healthcare from the inside, this means working across competitive boundaries and borrowing best practices from sister industries as we work to identify the root cause of these issues and provide meaningful and preventative solutions.

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A Bizarre Claim of Right to Try

Kelly McBride Folkers
Andrew McFayden
Arthur Caplan

By ARTHUR CAPLAN, KELLY MCBRIDE FOLKERS, and ANDREW MCFADYEN 

A patient with glioblastoma recently received an experimental cancer vaccine at the University of California, Irvine. Notably, this is being hailed as the first case of someone utilizing the Right to Try Act of 2017. ERC-USA, a U.S. subsidiary of the Brussels-based pharmaceutical company Epitopoietic Research Corporation, says it provided its product, Gliovac, to the patient at no cost. The vaccine is currently undergoing Phase II clinical trials. A handful of people in Europe have received access to it through “compassionate use.” This patient did not qualify for ongoing clinical trials in the U.S. The patient, who remains anonymous, is the first known individual to receive an experimental medicine that has not been approved by the FDA, as permitted under the federal right to try law.

Glioblastoma is a nasty cancer – John McCain and Ted Kennedy passed away after battling the disease for just over a year. We believe that patients with terminal illnesses, like those with glioblastoma, should have every reasonable tool at their disposal to treat their disease.

That being said, we’ve argued before that right to try laws are not the best way to help desperate patients. They still aren’t. The number of cases claimed to date is exactly one. And, further examination of what we know about this case does not make a strong argument for the widespread usage of the right to try pathway.

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Health in 2 Point 00, Episode 63 Walgreens & Fedex partnership, Verily’s adherence program, & more!

Today on Health in 2 Point 00, Jess and I get festive for the holidays. In this episode, Jess asks me about Walgreens and its new partnership with FedEx for next day prescription delivery and with Verily to help patients with prescription adherence. She also asks me about blockchain startup PokitDok getting its assets acquired by Change Healthcare. Lots of job changes are happening as well. Amy Abernethy, the chief medical officer at Flatiron Health, was named Deputy Commissioner of the FDA. Rasu Shrestha, who was previously at the University of Pittsburgh Medical Center, is the new chief strategy officer of Atrium Health. Finally, Zane Burke, who recently stepped down as president of Cerner, was just hired as Livongo’s new CEO, while Glen Tullman remains executive chairman of the company. Dr. Jennifer Schneider was also promoted from the company’s chief medical officer to president. We have one more episode of Health in 2 Point 00 for 2018, so be on the lookout for our year-end wrap-up. —Matthew Holt

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