2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood ...
Harvard Health: Chronic Fatigue Syndrome Is Rising
Bone-deep exhaustion not eased by rest, lasting six months or more. Brain fog. Pain. These and other symptoms are hallmarks of myalgic encephalitis/chronic fatigue syndrome (ME-CFS). People who have it find their symptoms often spike after minor daily tasks, work, and other exertions.
A new CDC report estimates 3.3 million Americans -- including many with long COVID -- may have this tricky-to-diagnose condition. Below is one such story drawn from the Health Story Collaborative series on chronic illness, "Making the Invisible Visible," which we'd like to share with our readers. To go straight to the video, click here.
Advertisement
Edited and condensed for clarity
Millions of Americans live with chronic illness. But how authentically do we tell -- or share -- those stories? Chronic illness doesn't inevitably strengthen us or lead to transformation, as popular cultural narratives often stress. It can feed the sense of being alone in a world of the well. And a long-term illness may not be diagnosed for years or unfold neatly from one clear point to the next.
Advertisement
As Dr. Annie Brewster, the founder and executive director of Health Story Collaborative (HSC), notes, "we can't control what happens to us, but we can control the meaning we make." Jonathan Adler is chief academic officer of HSC and a psychologist who focuses on the healing power of narrative. Working together, the two have helped people dig deep to shape very personal stories and share truths about illness through audio, video, and art.
Below we share a few moments from the experiences of Lili, a basketball-loving, hard-charging college student juggling theater roles, sports, and a heavy course load with apparent ease until crippling fatigue descended.
"I could hardly wake up to my alarm and drag my body along with me to classes and rehearsals," Lili recalls. A treatable case of hypothyroidism -- which does indeed cause fatigue -- was merely round one. Stimulants prescribed by a therapist helped, but when graduation passed and she stopped taking them, bone-deep exhaustion flooded back, leaving her largely bedridden and without a diagnosis for endless months.
"My bones weighed 10 pounds. Thoughts flitted in and out but never stuck," Lili says. Eventually a specialist in infectious diseases helped her put a name to the health issues so radically affecting her life. "With crippling fatigue, severe brain fog, and post-exertional malaise -- crashes caused by activities such as talking, showering, eating, walking, texting -- he told me that I qualified for a diagnosis of ME-CFS: myalgic encephalitis, better known as chronic fatigue syndrome."
The losses of chronic illness are many. "When my body was taken away from me, I lost a huge part of my identity. In many ways being athletic and strong is a ginormous part of who I am -- or who I was," Lili says. "My mind no longer works the way it used to, like I got a critical software update but it didn't quite download, so now I'm just stuck on the blue screen with the cursor blinking away."
Lili's path (or paths) forward isn't yet clear. When you grapple daily with a chronic illness, recovery isn't the golden arc shown in movies or popular in print. "Perhaps one day all of this will consolidate into one clear picture, but I think it will continue in this way -- a messy, gappy, one-day-at-a-time kind of way," she says. "There's no resolution to my story. It's still being written."
View the full story Lili shared with the Health Story Collaborative (video sponsored by Harvard Pilgrim Health Care, Point 32 Health Foundation, and Tufts Health Plan)
Tackling Thyroid Eye Disease With Teprotumumab
Illustration of Proptosis
All About Vision, Illustrated by Laurie O'KeefeThis story is part of a series on the current progression in Regenerative Medicine. This piece is part of a series dedicated to the eye and improvements in restoring vision.
In 1999, I defined regenerative medicine as the collection of interventions that restore tissues and organs damaged by disease, injured by trauma, or worn by time to normal function. I include a full spectrum of chemical, gene, and protein-based medicines, cell-based therapies, and biomechanical interventions that achieve that goal.
Thyroid eye disease (TED) is an autoimmune disorder that causes inflammation of the muscles and tissues around the eyes. This can lead to proptosis or bulging of the eyes, diplopia or double vision, and a significant reduction in the patient's quality of life. TED is most often connected to Graves' disease.
In this autoimmune condition, the thyroid gland overproduces hormones. Still, it can also occur in patients with Hashimoto's thyroiditis or as a result of radiation therapy to the head and neck.
What is Thyroid Eye Disease?Thyroid eye disease can be explained simply by saying that it is a disease where autoantibodies target specific eye cells, causing them to bulge out and compress the optic nerve. This can lead to vision problems and even blindness in severe cases.
In more detail, the immune system produces autoantibodies that activate specific receptors. These receptors then trigger the release of cytokines, which are chemical messengers that cause inflammation and fibrosis in the eye tissues. As a result of this inflammation, the extraocular muscles become inflamed and swollen, leading to a range of symptoms, including proptosis or bulging of the eyes, double vision, and exposure keratopathy.
Proptosis occurs due to the swollen muscles pushing the eyeball forward, leading to an abnormal eye protrusion. Double vision and exposure keratopathy can occur due to the abnormal position of the eyeball caused by the swollen muscles. Exposure keratopathy is when the cornea, the transparent outer layer of the eye, becomes dry and damaged due to inadequate protection from the eyelid.
Current Common TreatmentsCurrently, the mainstay of treatment for TED is glucocorticoids, such as prednisone or methylprednisolone, powerful anti-inflammatory drugs that can help reduce swelling and inflammation. However, these drugs can also cause significant side effects, including weight gain, mood changes, and increased risk of infection.
In addition to glucocorticoids, doctors may also recommend other treatment options based on the severity of the condition and the patient's needs. Radiotherapy, which uses high-energy radiation to target the tissues in and around the eyes, can effectively reduce inflammation and swelling. Immunosuppressants, such as mycophenolate or azathioprine, may also suppress the immune system and prevent further damage to the eye tissues.
In some cases, surgery may be necessary to correct the position of the eyes or to reduce pressure on the optic nerve. This can involve decompression surgery to remove bone from around the eyes or to remove fat from behind the eyes to create more space. In rare cases, doctors may recommend orbital radiotherapy, which is a type of radiation therapy that targets the eye socket to reduce inflammation and swelling.
A Novel Treatment for Thyroid Eye DiseaseTeprotumumab, a fully human monoclonal antibody, is a novel treatment option for TED. Its mechanism of action involves binding to and blocking the activity of IGF-1 R, preventing the activation of fibroblasts and thereby reducing inflammation and fibrosis. This medication was approved by the FDA in January 2020 for the treatment of active TED based on the results of two randomized, double-masked, placebo-controlled, parallel-group, multicenter trials.
A recent study published in the International Journal of Ophthalmology reviewed the efficacy and safety of teprotumumab for the treatment of TED, incorporating data from three clinical trials involving 341 patients. The analysis found that teprotumumab was significantly more effective than a placebo in reducing proptosis, or the protrusion of the eyes, in both the intention-to-treat and per-protocol populations. Patients treated with teprotumumab also showed improvements in diplopia response, overall response, and the clinical activity score, a measure of disease activity. Additionally, patients receiving teprotumumab experienced more significant gains in proptosis and quality of life than those receiving a placebo.
Despite these positive outcomes, the analysis also revealed that patients treated with teprotumumab are at a higher risk of adverse events, including serious complications such as muscle spasms and gastrointestinal reactions. However, these side effects were generally tolerable and manageable in clinical trials.
The Future of Thyroid Eye DiseaseThe findings on teprotumumab as a treatment for TED are highly promising, with evidence indicating that it may offer a safer and more efficient alternative to glucocorticoids. Although the studies analyzed had relatively short follow-up periods and small sample sizes, these limitations do not negate the potential benefits of teprotumumab.
Indeed, future research should prioritize examining this treatment's long-term safety and efficacy by studying patients' experiences with chronic-inactive TED. Additionally, identifying biomarkers that predict response to treatment is a crucial avenue for advancing our understanding of TED and optimizing treatment outcomes. These areas of study offer significant potential for improving patient outcomes and increasing medical knowledge.
To learn more about the eye, read more stories at www.Williamhaseltine.Com
Top 5 Healthcare Moments Of 2023
From a healthcare perspective, 2023 was all about a changing of the guard after years of operating in a pandemic mindset.
COVID-19 transitioned from pandemicity to endemicity and as such, industry leaders were able to shift their focus to other healthcare priorities.
This coincided with the unprecedented rise of GLP-1 drugs for treating diabetes and obesity, numerous major pharma and biotech deals as well as the historic approval of an Alzheimer's disease treatment.
Below are the top five healthcare moments of 2023.
1. GLP-1 drugs take overWeight loss drugs enjoyed more than a moment in the sun throughout the year.
Whether it was Novo Nordisk's Ozempic and Wegovy or Eli Lilly's Mounjaro and Zepbound, the GLP-1 class of weight loss drugs captured the attention of the general public.
These medicines also boosted the bottom lines of drugmakers.
According to Lilly's most recent earnings report, the pharma giant recorded a quarterly revenue increase of 37% thanks to the success of Mounjaro, which generated more than $1.4 billion in revenue during the period.
Similar to Lilly, Novo enjoyed an exceptionally strong quarter thanks to its weight-loss drugs, with the sale of GLP-1 diabetes drugs rising 49% while obesity care products grew 174%. Currently, Novo has a higher market capitalization than the gross domestic product of its home country of Denmark.
The financial success of these drugs has prompted other drugmakers to try to get in on the action, with AstraZeneca buying the rights to a once-daily oral GLP-1 drug candidate from Eccogene for $185 million upfront.
However, not everyone has been successful making inroads in this space, with Pfizer discontinuing a twice-daily version of its obesity drug danuglipron and, more recently, Structure Therapeutics acknowledging that the efficacy of its oral GLP-1 receptor agonist among patients with type 2 diabetes fell below that of a rival pill being developed by Lilly.
Still, despite this flurry of activity, some industry observers have wondered whether diabesity drugmakers have maxed out on their opportunities and should shift from magnitude to quality of weight loss.
2. FDA grants Leqembi full approvalThe first six months of 2023 marked significant progress on the Alzheimer's treatment front.
Leqembi, developed by Eisai and Biogen, received an accelerated approval from the Food and Drug Administration on January 6.
Later that month, the drug had its initial recorded sales and first prescription written, followed by the first patient infusion on February 3.
In early June, external advisors to the FDA unanimously recommended Leqembi for full approval. On July 6, the FDA granted traditional approval to Leqembi in a watershed moment for the Alzheimer's patient population.
The drug is on track to be a blockbuster, with one analysis projecting nearly $13 billion in global sales by 2028.
3. Major pharma deals closeBig Pharma went full tilt when it came to dealmaking this year.
The biggest transaction was Pfizer's $43 billion acquisition of oncology company Seagen, a deal which gave insights into what organizational direction the pharma giant is heading as well as how healthy the biotech space is.
Another major deal was Amgen's $27.8 billion acquisition of Horizon Therapeutics, which closed months after the Federal Trade Commission challenged the merger as a sign of rampant consolidation in the pharma space.
Ultimately, the agency signed off on the the California-based pharma giant's purchase of the rare disease Irish biotech by prohibiting Amgen from bundling its products with either Horizon's Tepezza, Krystexxa, or medications used to treat thyroid eye disease and chronic refractory gout.
Additionally, Amgen "may not condition any product rebate or contract terms" related to products on sale or position either one of these drugs. The company is also prohibited from using any product rebate or contract term to "exclude or disadvantage" any product that would compete with Tepezza or Krystexxa.
Finally, AbbVie kept itself busy with a series of major transactions.
Earlier this month, the company bought Cerevel, a biotech focused on developing treatments for central nervous system disorders, for $8.7 billion. This came one week after AbbVie announced a $10.1 billion acquisition of ImmunoGen, a clinical-stage biotech that manufactures antibody-drug conjugates.
AbbVie also struck a deal to acquire neurodegenerative disease specialist Mitokinin, paying shareholders $110 million at closing for the purchase. The deal could grow by another $545 million depending on hitting certain developmental and commercial milestones
4. The COVID-19 pandemic emergency phase endsAfter the deaths of more than 1.1 million Americans, the emergency phase of the COVID-19 pandemic in the U.S. ended in May. The World Health Organization also declared an end to the pandemic's emergency status.
In early April, President Biden signed an end to the public health emergency but the last provisions lapsed, including coverage for at-home COVID-19 tests and vaccine requirements for federal jobs.
At the time, HHS Secretary Xavier Becerra released a statement acknowledging the end of the COVID-19 emergency phase but also emphasizing that the virus remains a "public health priority" for the agency.
The virus is still lingering across the U.S., albeit it is not spreading or killing as many Americans as it did in years prior, but has raised the concern over the seasonal spread of other respiratory illnesses like the flu and RSV.
One unanswered question following three years of public health crisis, widespread death, societal upheaval and rampant medical misinformation is where the healthcare industry goes from here.
5. The Syneos sagaA 2023 MM+M Agency honoree went from publicly-traded to private in the course of a few months.
In May, a cohort of private equity firms announced a $7.1 billion deal to take Syneos Health private, citing unanimous approval of the board of directors and receiving approval from shareholders in early August.
The company had been in search of a buyer since initiating a comprehensive review in early 2020 that was ultimately put on hold due to the COVID-19 pandemic.
In late September, Elliott Investment Management, Patient Square Capital and Veritas Capital closed the deal and changes were quickly made days later.
Syneos named Colin Shannon as CEO in early October, taking over the role from Michelle Keefe, who remained on the executive leadership team as well as the board of directors.
Comments
Post a Comment