Monthly Archives: May 2022

Alternative Medicine often referred to as integrative, or complementary medicine, including a wide range of medical treatments, products, practices, and health care systems that are not a part of standard/ conventional medical care. Alternative medicine is categorized together with complementary medicine and called complementary and alternative medicine (CAM). Worldwide a significant number of people irrespective of their education, age, and status rely on various forms of alternative medicine to treat or ameliorate disease. Alternative Medicine which follows whole body care approach are generally less expensive and uses natural products such as oils, herbs, metals, and minerals.

As per the study conducted by John A. Astin, education and poorer health status may predict alternative medical use. Sometimes people refer to alternatives healthcare as these medicines are more identical and coinciding with their own values, beliefs, and philosophical orientations toward health and life. The people with poorer health status refer to alternative medical use if the traditional healthcare system is unable to address their present healthcare need adequately, Similarly the lack of pathophysiological explanation for some disease, higher costs and number of tests and visiting different practitioners, often leads people to seek out Alternative Medicine as a treatment option.

As per the study conducted by the National Center for Complementary and Alternative Medicine (NCCAM) , about 38 percent of U.S. adults and about 12 percent of children are using some form of alternative medicine. Alternative medicines encompass a wide range of medicines practices, some of the most commonly used Alternative Medicine includes:

Developed in the late 18th century by Samuel Hahnemann, Homeopathy is an alternative medical system that is based on the belief that the body can cure itself. In Homeopathy the patient uses a dilute amount of natural substances, like plants and minerals to treat various ailments. It is most common in European countries. As per the National Health Interview Survey (NHIS) (2012), in Americans, an estimated 5 million adults and 1 million children used homeopathy in the previous year.

Homeopathy believes in like cures like treatment concept that suggests that a disease can be treated or cured by a substance that produces similar symptoms in healthy people. Homeopathy is in use for a wide range of health conditions such as dermatitis, depression, migraines, irritable bowel syndrome, hay fever, rheumatoid arthritis, high blood pressure, allergies, and many others.

However, there are some issues pertaining to the use of Homeopathy products. Homeopathy products lack scientific evidence and efficacy. In the past few years, certain European countries and the US have raised certain questions about the effectiveness and risk associated with Homeopathy products on their citizens health.

Naturopathy evolved as Alternative medicine in Europe during the 19th century. Naturopathy/ naturopathic medicine is a combination of traditional practices and health care approaches based on vitalism, folk medicine, the healing power of nature, and many others.

The Naturopathy consists of a wide range of non-invasive techniques such as herbal medicine (Herbalism), hydrotherapy (water therapy), physical therapies (which includes massage, bowen, and acupressure), nutrition and dietary modifications, homeopathic medicine, kinesiology, hygiene therapy, and nature cure. Naturopathy also employs other practices such as meditation, stress management, and relaxation. Today Naturopathy is practiced in many countries and is regulated by the government and authorities.

Originated in India about more than 3,000 years ago, Ayurveda (Indian medical system) is a natural system of medicine that relies on a natural or holistic approach to physical, mental, and spiritual well being. Ayurveda as a treatment is a combination of products derived from plants, animals, metals, minerals, or other materials along with maintaining diet, exercise, and a better lifestyle.

The Ayurvedic approaches are used for the treatment of diseases and conditions such as pain, rheumatoid arthritis, type 2 diabetes, ulcerative colitis, and many others. In some recently conducted studies, Ayurvedic medicine is found effective in relieving cancer symptoms.

Ayurvedic medicine is mainly practiced in countries such as India, Nepal, and Sri Lankan. The main research and development activities related to Ayurvedic medicine is limited to these countries only. Outside the Indian subcontinent, Ayurvedic medicine has very little popularity.

Unani medicine is an alternative medicine system, originated in Greece about 2500 years back, presently practiced in the Middle- East and South-Asian countries. Unani Medicine considers the human body as a single unit and aimed at treating the body, mind, and soul.

Unani medicine follows various practices to deal with health and disease using herbal remedies, dietary practices, and various alternative therapies. Among all the practices the main focus of Unani medicine on the diet and the state of digestion. Unani medicine offers treatment options to all the systems and organs of the human body such as musculoskeletal, skin, liver, and immunology. Some recent studies on animals have suggested that Unani medicine is beneficial for Brain Health, Arthritis, and Cataracts.

Acupuncture is a Traditional Chinese medicine practice, which focuses on stimulating specific points on the human body, most often thin needles are inserted through the skin.

Studies have suggested that acupuncture is helpful in relieving pain such as neck pain, headache, back pain, and knee pain. Apart from controlling pain Acupuncture is helpful in treating illnesses and ailments such as nausea, vomiting, fatigue, hot flashes, xerostomia, neuropathy, anxiety, depression, and sleeping problems.Acupuncture is beneficial as it has very limited side effects, and it is also safe (provided performed correctly). However, in certain cases, Acupuncture can cause complications and effects on the human body such as infections, bleeding, bruising, injury to the organ and central nervous system.

Countries follow different laws and regulations for acupuncture practices. In some countries like the USA acupuncture needles are considered as medical devices, and in some insurance providers have started covering acupuncture as medical treatment.

Apart from these Siddha, some other most common Types of Alternative Medicine include chiropractic, aromatherapy, meditation, and others. Besides healing disease and illness, the Alternative Medicines are helpful in providing relaxation, increasing the energy levels of the body, improvement in posture and balance, treating some eating disorders, relieving stress and anxiety, pain relief, strengthening the immune system, and overall health & wellbeing. These Alternative Medicines are followed and practiced worldwide. However, the use of Alternative medicines is surrounded by several challenges and issues.

Alternative medicine consists of diverse theories and practices, which lack scientific evidence and outcomes. The standard/ conventional medical system is based on clinical trials and research methods that aim to provide safe and effective medical care, while alternative treatments lack solid research for its use and practice.

Sometimes the use of alternative medicine can be dangerous and life-threatening as all of these are not 100 percent proven treatments, also these therapies lack the standard guideline, potential side effects, and dosage intake. Similarly, in some countries due to issues regarding safety and efficacy, Alternative therapies are not approved by their health and regulatory authorities.

To combat the issues and challenges in Alternative medicine use, several steps are being taken. Worldwide, many doctors, scientists, and researchers are studying the method and use of Different Types of Alternative Medicine, which is helping them in gaining knowledge and understanding about these medicines. Some of the Alternative Medicines such as acupuncture, homeopathy, and Ayurveda are gaining popularity in western countries, more and more people are looking for these medicines for some diseases and illnesses such as back pain.

The Different Types of Alternative Medicine have different benefits and drawbacks, but all of them have the same goal that is to attain good health and wellbeing. The choice of Alternative Medicine may vary from person to person, his knowledge, and also the type of disease or illness he is suffering from. With the rising awareness, the demand for Alternative Medicine is expected to grow in newer geographies. In the USA, Accredited Naturopathic colleges and universities are offering courses and medical training in alternative medicine. While in some countries like India, several alternative systems of medicines have been approved and regulated by the government for the past few decades. These medical practices are co-existing and integrated into the healthcare system of the country over the years and providing benefits to a large number of people.

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Alternative Medicine | Different Types Of Alternative Medicines

For concierge medicine physicians, while the pandemic was difficult and demanding, their professional survivability was never in question.

In Part One, we described the role concierge medicine plays in extending the active years of experienced, dedicated doctors and helping to significantly ease the looming physician shortage. Now we consider how concierge medicine has sustained the practices of independent primary care physicians who are rapidly becoming a vanishing breed in the U.S.

Among the pandemics many heartbreaking statistics is this one: In 2020 and 2021, more than 24,000 independent practices were reported permanently or temporarily closed. We now have an even clearer picture of the pandemics impact on private practitioners with new data from Avalere and the Physicians Advocacy Institute (PAI) showing that almost three quarters of U.S. doctors now work for hospitals, health systems or corporate entities. That represents an almost 20% jump since 2019.

"COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we've seen in recent years," according to Kelly Kenney, chief executive officer of PIA. This study underscores the fact that physicians across the nation are facing severe burnout and strain. Between the financial stress that the pandemic had on practices, because they certainly had little revenue for a while, and the stress that physicians have felt mentally, you can't overstate that."

While a sense of normalcy is thankfully returning to everyday life, for primary care physicians in traditional fee-for-service practices, the situation remains bleak. According to the most recent Primary Care Collaborative survey, more than half of physician say primary care is crumbling, over 40% report describe themselves as mentally and financially fragile, one third report they are currently denied and/or seriously overdue payments from insurers and health plans, and only 21% find the fee-for-service form of payment sufficient.

We have long understood that the traditional fee-for-service payment model is simply not sustainable. Consider that since 2001, Medicare physician payment has fallen 20%, adjusted for inflation, while the cost of running a medical practice has increased 39% in that same time period. Becoming a hospital-employed physician doesnt provide a neatly packaged solution either. As reported in a recent Forbes article, after acquiring a physician practice, prices for healthcare services increase by 14% and hospital revenues rise by nearly 20%. However, most physicians are not benefiting, but are in fact, earning 20% less than independent practitioners, according to a 2022 Medscape survey.

Most troubling, as a result of the myriad challenges with seemingly no end, 25% of the physicians surveyed by the Primary Care Collaborative expect to leave primary care in the next three years. A December 2021AMA surveyalso reported that one in five physicians said they would likely leave their current practice within two years. The impact of this physician exodus is an incalculable loss that will be felt for many years to come.

However, for concierge medicine physicians, while the pandemic was difficult and demanding, their professional survivability was never in question. A stunning zero percent of concierge medical practices were closed during the pandemic, and they continue to thrive in 2022, based on a solid foundation of revenues driven by membership fees. Freed from financial worries and overloaded patient panels, concierge physicians not only keep their doors open, but their minds and hearts as well.

At Specialdocs I am gratified that we are able to offer a remarkably effective solution with proven resilience throughout two decades of relentless change. Below is a sampling of comments from our physician clients who sustained their practices and restored their passion for patient care with a thoughtful transition to our membership medicine model.

Dr. N.M., Atlanta, GA: Before I made the change, I was burned out to the point where I knew I was done with medicine if this didnt work. I was so frustrated with the way things had continued to worsen over the last 15 years - I didnt want to end up like the proverbial lobster in a pot of gradually heated water that doesnt realize its being cooked until it was too late. Now I have a completely different practice and life and I cant imagine ever going back to the way things were.

Dr. M.S., Burbank, CA: My traditional practice had grown to the level where I was responsible for almost 4,000 patients and I was drowning. Appointments were always rushed and there was never enough time. I felt that it was inevitable that I was going to miss something or make a mistake and neglecting my personal health and family life was the price I was paying.Concierge medicine was, and still is, the best way to achieve a work-life balance that is rarely seen in a primary care practice.

Dr. I.K., Petoskey, MI: Despite surging demand for rheumatology specialty care, my private practice had become too challenging to sustain. The paperwork and administrative burdens for a solo rheumatologist had mushroomed in the last decade, requiring an inordinate amount of time for prior authorizations, step therapy and electronic health record documentation; concurrently reimbursements continued to decline. I recognize that while it may not be the answer for every doctor, changing to the concierge medicine model with Specialdocs was the only viable alternative to permanently closing my practice doors. It has proven to be a tremendous fit for my career. Patients are now able to get an appointment the same or next day. We have unrushed visits that are conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment. I also have more time to coordinate care and give patients prompt feedback on lab and study results. From the first night of transition, I was able to sleep well, knowing my patients were being better served, my staff was happier, and that I could continue to practice in a time of great change and challenge for rheumatology.

Dr. Z.C., Nanuet, NY:My change to concierge medicine early in 2020 was precipitated by years of practicing like a hamster on a particularly relentless wheel, seeing up to 40 patients each day, with non-stop calls and endless paperwork afterward. Among several, mostly unpalatable options, including employment by a hospital, grinding it out until retirement or leaving the profession altogether, only the change to a concierge medical practice offered a workable solution for me. Had I not begun my concierge practice shortly before the pandemic started, I would have been totally unprepared to face an empty waiting room and a dramatic drop-off in office visits. Even more importantly, my patients would not have received the unlimited time and attention I was profoundly thankful to provide.

Dr. B.B., Brookline, MA: Making the change to concierge medicine saved our entire organization, including many who had worked with us for their entire careers. In 2020, it became increasingly clear that the pandemic was going to result in our shuttering the practice. I was compelled to find a way to reinvent ourselves and preserve the practice we had built with the utmost care for more than 25 years. Our transition with Specialdocs allows us to offer an approach that benefits patients enormously with time to focus on non-invasive treatments, prevention and wellnessand has restored our joy in practicing medicine.

Terry Bauer is CEO ofSpecialdocs,a concierge medicine pioneer that has transformed physicians professional lives since 2002, empowering them to deliver personalized patient care

Original post:

The Physician Shortage, Part Two: Keeping the Doors Open with Concierge Medicine - Medical Economics

Tucson, AZ Regenerative medicine contains a broad category of non-surgical therapies that aim to stimulate the healing/repair of damaged tissue. To explore the solutions, individuals can visit QC Kinetix (Academy), a Tucson-based regenerative medicine clinic with the mission of providing natural pain treatments and restorative therapies. The Pain control clinic comprises a team of medical providers committed to improving the quality of life of their patients, allowing them to resume performing normal chores, playing with their children, or training for marathons.

The team utilizes minimally invasive procedures, natural treatment protocols, and advanced medical technology to improve pain, decrease inflammation, and repair degenerated tissues. With the knowledge that joint pain/musculoskeletal injuries are frustrating to deal with, the team provides personalized services throughout a patients clinical experience. They treat patients with the highest level of service and respect while also educating them about their pain, conditions, treatment options, and the most appropriate regenerative therapies.

Sports injuries are commonly treated/managed with rest, ice, compression, elevation, medication, surgery, steroids, or physical therapy. While they may get a patient through their injuries, regenerative medicine may prove to be a better option since it takes advantage of the bodys natural healing capabilities. The alternative therapies offer relief from tennis elbow, torn Achilles tendon, knee pain, golfers elbow, shoulder pain, tendon/ligament tears, ankle pain, torn rotator cuff, wrist pain, and low back pain. QC Kinetix (Academy) integrates traditional sports treatments with regenerative medicine to help athletes, weekend warriors, or avid adventurers recover quickly. This approach also strengthens existing tissues and reduces the risk of future injuries.

Most people in Tucson suffer from conditions that affect the ligaments, muscles, bones, and tendons as a result of trauma, jerking movements, falls/sprains, repetitive movements, or overuse. When traditional treatments for musculoskeletal pain such as painkillers, anti-inflammatories, massage, or physical therapy fail to provide the relief a patient needs, they can visit the regenerative medicine clinic for Tucson back pain treatment, low back pain treatment, and tendon/muscle/ligament pain treatment solutions.

Additionally, QC Kinetix (Academy) slows down the progression of arthritis pain using a variety of treatment methods that use the bodys existing healing mechanisms to decrease pain without invasive surgical procedures, medication, or extensive physical therapy. Many patients have discovered the clinic while searching for long-term solutions for inflamed, irritated, and worn-down cartilage, connective tissues, and bones caused by arthritis pain.

A first visit to the clinic includes a thorough examination where a provider evaluates a patients overall health history, goals, and needs before determining the most suitable alternative treatments for their joint pain or musculoskeletal injuries. Learn more about their Tucson office by calling (520) 497-4955 or visiting the clinics website. QC Kinetix (Academy) is located at 310 N Wilmot Rd, Suite 101, Tucson, AZ, 85711, US.

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Company NameQC Kinetix (Academy)Contact NameScott HootsPhone(520) 497-4955Address310 N Wilmot RdSuite 101CityTusconStateAZPostal Code85711CountryUnited StatesWebsitehttps://qckinetix.com/tucson/academy

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QC Kinetix (Academy) is a Tucson Regenerative Medicine Clinic offering Alternative Treatments for Joint Pain - Digital Journal

DetailsCategory: AntibodiesPublished on Wednesday, 25 May 2022 09:50Hits: 58

Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial

This KEYTRUDA combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC

Decision marks fifth approval for KEYTRUDA in a breast or gynecologic cancer in the EU in less than one year

RAHWAY, NJ, USA I May 24, 2022 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.

The approval is based on results from the pivotal Phase 3 KEYNOTE-522 trial, in which KEYTRUDA in combination with chemotherapy before surgery and continued as a single agent after surgery prolonged event-free survival (EFS), reducing the risk of EFS events or death by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) compared to neoadjuvant chemotherapy alone in this patient population. Median follow-up time for all patients was 37.8 months (range, 2.7-48).

KEYNOTE-522 was the first large, randomized Phase 3 study to report a statistically significant and clinically meaningful EFS result among patients with stage II and III TNBC. With this decision, this KEYTRUDA combination becomes the first immunotherapy option approved for patients in the European Union (EU) in this setting.

Triple-negative breast cancer has a high risk of recurrence within the first five years, so its meaningful for patients to have access to new therapies that can reduce the risk of disease progression, said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. The approval of this KEYTRUDA regimen marks a turning point for patients with high-risk early-stage TNBC, as they now have an immunotherapy option in early stages of the disease that has demonstrated significant improvements in pathological complete response and event-free survival compared to neoadjuvant chemotherapy.

The safety of KEYTRUDA plus chemotherapy has been evaluated in 3,123 patients across tumor types. The incidence of Grade 3-5 adverse reactions in patients with TNBC was 80% for KEYTRUDA plus chemotherapy and 77% for chemotherapy.

KEYTRUDA was first approved in Europe to address an unmet need in certain patients with metastatic TNBC, and todays approval extends the use of KEYTRUDA to more patients facing this difficult-to-treat cancer this time in earlier stages of TNBC, said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. We are very proud that todays approval marks the fifth indication for KEYTRUDA in Europe for patients with breast or a gynecological cancer, an important area where patients need continued research and innovation.

This approval allows marketing of this KEYTRUDA regimen in all 27 EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland. This is the second indication for KEYTRUDA in breast cancer in Europe. In October 2021, KEYTRUDA plus chemotherapy was approved for the first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC.

Merck is committed to delivering meaningful advances in gynecologic and breast cancers to patients around the world through its extensive clinical development program across its oncology portfolio of investigational and approved medicines. Within just the last year, KEYTRUDA has been approved in Europe for five new indications across breast, cervical and endometrial cancers as monotherapy and in novel combinations.

About KEYNOTE-522

The approval was based on data from KEYNOTE-522 (ClinicalTrials.gov, NCT03036488), a randomized, double-blind Phase 3 trial. The dual primary endpoints were pathological complete response rate, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery, and EFS, defined as the time from randomization to the time of first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer or death from any cause. A key secondary endpoint was overall survival. The study enrolled 1,174 patients who were randomized 2:1 to receive either:

About triple-negative breast cancer (TNBC)

Triple-negative breast cancer is the most aggressive type of breast cancer, which has the highest risk of recurrence within the first five years after diagnosis and is associated with worse outcomes compared to other forms of breast cancer. Approximately 10-15% of patients with breast cancer are diagnosed with TNBC. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. Triple-negative breast cancer tends to be more common in people who are younger than 40 years of age, who are Black or who have a BRCA1 mutation.

About Mercks early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,700 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Mercks focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

SOURCE: Merck

Original post:

European Commission Approves KEYTRUDA (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery...

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The researchers also identified specific genes associated with resistance to most available drugs therapies, commonly referred to as refractory disease, which could provide the key to developing new, successful drugs to help these people.

While there has been much progress made over the past decades in treating arthritis, a significant number of patients (approximately 40%) do not respond to specific drug therapies, and 5-20% of people with the disease are resistant to all current forms of medication.

The researchers carried out a biopsy-based clinical trial, involving 164 arthritis patients, in which their responses to either rituximab or tocilizumab two drugs commonly used to treat RA were tested. The results of the original trial published in The Lancet in 2021 demonstrated that in those patients with a low synovial B-cell molecular signature only 12% responded to a medication that targets B cells (rituximab), whereas 50% responded to an alternative medication (tocilizumab). When patients had high levels of this genetic signature, the two drugs were similarly effective.

As part of the first-of-its-kind study, funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, the Queen Mary team also looked at the cases where patients did not respond to treatment via any of the drugs and found that there were 1,277 genes that were unique to them specifically.

Building on this, the researchers applied a data analyses technique called machine learning models to develop computer algorithms which could predict drug response in individual patients. The machine learning algorithms, which included gene profiling from biopsies, performed considerably better at predicting which treatment would work best compared to a model which used only tissue pathology or clinical factors.

The study strongly supports the case for performing gene profiling of biopsies from arthritic joints before prescribing expensive so-called biologic targeted therapies. This could save the NHS and society considerable time and money and help avoid potential unwanted side-effects, joint damage, and worse outcomes which are common amongst patients. As well as influencing treatment prescription, such testing could also shed light on which people may not respond to any of the current drugs on the market, emphasising the need for developing alternative medications.

Professor Costantino Pitzalis, Versus Arthritis Professor of Rheumatology at Queen Mary University of London, said: Incorporating molecular information prior to prescribing arthritis treatments to patients could forever change the way we treat the condition. Patients would benefit from a personalised approach that has a far greater chance of success, rather than the trial-and-error drug prescription that is currently the norm.

These results are incredibly exciting in demonstrating the potential at our fingertips, however, the field is still in its infancy and additional confirmatory studies will be required to fully realise the promise of precision medicine in RA.

The results are also important in finding solutions for those people who unfortunately dont have a treatment that helps them presently. Knowing which specific molecular profiles impact this, and which pathways continue to drive disease activity in these patients, can help in developing new drugs to bring better results and much-needed relief from pain and suffering.

The incorporation of these signatures in future diagnostic tests will be a necessary step to translate these findings into routine clinical care.

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New study shows genes can predict response to arthritis treatment and paves the way for future drug development - QMUL

Most people withCOVID-19will experience a mild illness, and they'll be able to take care of themselves at home. But someespecially those withunderlying health conditionscould benefit from one of several COVID-19 treatments. Some of these are available in pill form and others are given intravenously or by injectionand all of them must be prescribed by a health care provider.

It's important to remember that while new treatments are effective at reducing the severity of symptoms and helping prevent hospitalization and death in people who become infected with COVID-19, they are not a substitute forvaccination, which remains the single most effective strategy to prevent serious disease. Read on to find outYale Medicine's guide to COVID-19 treatmentsand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

What is it?Paxlovidis Pfizer's brand name for an antiviral oral medication (in pill form) that combines two generic drugs, nirmatrelvir and ritonavir. It was the first COVID-19 antiviral pill to receive Food and Drug Administration (FDA)emergency use authorization (EUA), and the National Institutes of Health (NIH) has prioritized its use over other treatments for eligible patients. It is meant for people who have a current COVID-19 infection.

When it was authorized:December 2021.

Who can get it:People ages 12 and up who weigh at least 88 pounds, who have a positive COVID-19 test result, have symptoms, and are at high risk for developing severe COVID-19.

How you take it:For most people, the dose is three pills twice daily for five days, and it must be started within five days of developing COVID-19 symptoms.

Side effects:They're usually mild, and may include altered or impaired sense of taste, diarrhea, increased blood pressure, or muscle aches. Because Paxlovid is still being studied, it's possible that all of the risksaren't yet known.

How it works:Paxlovid is an antiviral medication, a type of drug that stops viruses from replicating inside the body's cells. Two of the pills in the three-pill dose are nirmatrelvir, which prevents the SARS-CoV-2 virus from replicating. The other medication is ritonavir, which gives the first drug's levels a boost by essentially shutting down its metabolism in the liver, so that nirmatrelvir levels remain high and can work longer to fight the infection.

How well it works:89% efficacy against hospitalization and death in theclinical trialin which all participants were unvaccinated.Though the trial was conducted beforeOmicronbecame the predominant variant, Pfizer says that the treatment appears to work well against it. This is backed up bythree laboratory-based studies(all of which involved Pfizer) that have not yet been published in peer-reviewed medical journals.

What else you should know:Paxlovid interacts with many medications, including common ones that are sold over the counter like St. John's Wort, blood thinners, cholesterol medicines, and many more. In some cases, this can cause complications that are serious enough to justify not taking it. So, it's important for doctors to have an up-to-date medication list, including over-the-counter medications and supplements; they may consider other treatments for some patients.

There is no experience treating pregnant women or breastfeeding mothers with Paxlovid. Women who are pregnant should discuss their options with their health care provider. It is also recommended that patients use effective barrier contraception or do not have sexual activity while taking Paxlovid.

Paxlovid is also not recommended for patients with severe liver or kidney disease and those withHIVwho are not on treatment.

What is it?The antiviral treatment remdesivir, sold under the brand name Veklury, was the first COVID-19 therapy to get full FDA approval, and, so far, it's still the only one. Although originally used in COVID-19 patients only after they were hospitalized, new data suggests it can be helpful in outpatients who become infected and who are at high risk for severe disease.It is meant for people who have a current COVID-19 infection.

When it was authorized:Full approval was granted in October 2020. (It was first authorized in May 2020 for critically ill patients who were being treated with oxygen for COVID-19.) The authorization was later expanded to include other groups, and it was authorized to treat non-hospitalized patients in January 2022.

Who can get it:Fully approved for children and adultswho are at high risk for severe disease. Infants and children must be at least 28 days old, weigh over 6.5 pounds or more, and be either hospitalized or at high risk for severe illness.

How you take it:Via injection or IV and administered only in a health care setting by a health care professional. For outpatients, the treatment is a three-day course of infusions that must be initiated within seven days of symptom onset.

Side effects:Nausea is the most common side effect. Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed following treatment. There is insufficient data on the safety of using remdesivir in pregnant women or women who are breastfeeding; patients should speak with their health care provider.

How it works:Administered intravenously to patients who are in the hospital or in an ambulatory setting, the drug inserts itself into new viral genes to block replication of the virus, shortening the time it takes seriously ill patients to recover. A number of experts believe that the drug may work best early in the course of an infection.

How well it works:87% reduction in risk of hospitalization in non-hospitalized patients given a three-day course, according to a study published inThe New England Journal of Medicinein December 2021.

What else you should know:For hospitalized patients, research in early 2020 showed that the therapy reduced length of stay (the number of days in the hospital) from 15 days to 12. However, questions have been raised about remdesivir's trial results for hospitalized patients. In late 2021, the World Health Organization (WHO) recommended against remdesivir after releasingdatathat showed disappointing results. Still, many U.S. hospitals continue to provide this medication.

This is one of two NIH-preferred therapies (after Paxlovid) for COVID-19.

What is it?Bebtelovimab is an FDA-authorized investigational monoclonal antibody treatment that was developed by Eli Lilly. Not all authorized monoclonal antibodies have worked against all of the SARS-CoV-2 variants. However, data showing bebtelovimab's efficacy againstOmicron and its BA.2 subvariantprompted the FDA to authorize the drug through an EUA.It is meant for people who have a current COVID-19 infection.

When it was authorized:February 2022.

Who can get it:Adults and children ages 12 and up who weigh at least 88 pounds. They must have a positive COVID-19 test result and be at high risk for developing severe COVID-19.

How you take it:An intravenous injection is given for at least 30 seconds. Patients are observed by a health care provider for at least an hour after injection. Bebtelovimab must be given within seven days of symptom onset.

Side effects:There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to theFDA fact sheet.The sheetalso provides a list of potential side effects the FDArecommends reporting to a medical provider, and reports that allergic reactions can happen during and after injection. Because bebtelovimab is still being studied, it's possible that all of the risks aren't yet known.

How it works:It binds to the spike protein that causes COVID-19, similar to other monoclonal antibodies that have shown efficacy against hospitalization and death from the disease.

How well it works:The EUA for bebtelovimab was supported by clinical and nonclinical data that showed it has efficacy against Omicron and its BA.2 subvariant.The clinical data was based on a Phase 2 trial that treated non-hospitalized patients with bebtelovimab alone or together with another drug called etesevimab. That study is available in apreprint, whichhas not yet been peer-reviewed.

What else you should know:There is limited experience treating pregnant women or breastfeeding mothers. So, those patientsshould discuss their options and specific situation with their health care provider.

The NIH considers this to be an alternative treatment, whichshould be usedonly when neither of the NIH-preferred therapies (Paxlovid and remdesivir)are available, feasible to use, or clinically appropriate.

What is it?Molnupiravir, also known by the brand name Lagevrio, was developed by Merck and Ridgeback Biotherapeutics. It was heralded as a potential game-changer when the companies announced their initial clinical trial results in 2021. But when the data was finalized, it showed the drug to have lower efficacy than originally reported. Its FDA authorization came after a close vote that took into account the lowered efficacy and safety profile. The Centers for Disease Control & Prevention (CDC) now recommends that this drug should be used when the above-mentioned treatments aren't available.

When it was authorized:December 2021.

Who can get it:People ages 18 and up who are at high risk for hospitalization and death from COVID-19.

How you take it:Four capsules every 12 hours (for example, at 8 a.m. and 8 p.m.) for five days. It must be taken as soon as possible, within five days of symptom onset.

How it works:When the drug enters the bloodstream, it blocks the ability of the SARS-CoV-2 virus to replicate.

How well it works:30% efficacy against hospitalization and death. Merck initially reported the efficacy as 50%, but later adjusted that figure. Some laboratory studies from Merck have shown that molnupiravir is effective against the Omicron variant.

Side effects:Diarrhea, nausea, and dizziness are the most common side effects. You should stop taking the pills right away if you have an allergic reaction. Because molnupiravir is still being studied, it's possible that all of the risks aren't yet known.

What else you should know:Molnupiravir is not recommended during pregnancy, since it has not been studied in pregnant women and has shown potential harm inin vitrostudiestherefore, the true risk for harm to an unborn baby is unknown.

Individuals who are able to become pregnant should use reliable birth control during treatment and for four days after their last dose. It is also not known if molnupiravir could affect sperm, so individuals who are taking molnupiravir and who are sexually active with partners who are able to become pregnant should use reliable birth control during treatment and for three months after the last dose. (Studies to understand the risk to sperm beyond three months are ongoing.)

The NIH considers this to bean alternativetreatment, whichshould be usedonly when neither of the NIH-preferred therapies (Paxlovid and remdesivir)are available, feasible to use, or clinically appropriate.

What is it?Evusheld is a monoclonal antibody, but different than the other medications listed above. It combines two drugs, tixagevimab and cilgavimab. It is not designed to treat COVID-19; rather, its purpose is to keepimmunocompromised peoplewho do not respond to vaccination from getting sick. Developed by AstraZeneca, it is the first long-acting antibody to receive an EUA for pre-exposure prevention of COVID-19.6254a4d1642c605c54bf1cab17d50f1e

When it was authorized:December 2021.

Who can take it:Anyone 12 years or older who weighs at least 88 pounds and is at risk for severe illnessor those who cannot receive COVID-19 vaccines. Anyone taking the medication should have neither an active COVID-19 infection norbeen recently exposed to a close contact who is infected.

How you take it:A health care provider will give one dose of Evusheld in the buttocks in two separate injections (of tixagevimab and cilgavimab, respectively), one after the other, with repeat doses every six months, while SARS-CoV-2 remains in circulation.Patients will be monitored for an hour after each injection. In March, the dosage for Evusheld was doubled, so patients who received the two injections prior to the change in dosage recommendations should talk to their doctor about the need to repeat treatment.

Side effects:Any intramuscular injection can cause hypersensitivity, pain, bruising, soreness, swelling, possible bleeding, or infection at the injection site. Tell your health care provider if you experience any allergic reactions during and after an injection. Serious but uncommon cardiac adverse events have occurred in the clinical trial.

Contact your health care provider or get medical help right away if you have any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach, or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs. Because Evusheld is still being studied, it's possible that all of the risks aren't yet known.

How it works:It combines two antibodies with differentand complementaryactivities against the SARS-CoV-2 virus.

How well it works:According to a clinical trial, there was a 77% reduction in chances of getting COVID-19 initially; 83% six months after the treatment, according to theFDA news release. AstraZeneca says the drug should be effective for a year. It's important to note that the exact efficacy against the latest variants is still unclear. (Note: Because the trial did not include immunocompromised patients, it is also unclear If the 77% reduction would apply to those who are immunosuppressed.)

What else you should know:Evusheld is intended as an additional benefit for those who may not respond to vaccination or who cannot be vaccinated. People who get Evusheld may need to receive additional doses for ongoing protection if new variants emerge. The best timing for additional doses, if needed, is not yet known; it will depend on which SARS-CoV-2 variant is in circulation.

Note: If you are experiencingsymptoms of COVID-19and think you are eligible for a treatment, you can visit the governmentTest-to-Treat Locator. You can use the site to search for places near you where you can fill a COVID-19 prescription or identify sites that provide testing, medical care, and COVID-19 medications.

Follow the fundamentals and help end this pandemic, no matter where you liveget vaccinated ASAP; if you live in an area with low vaccination rates, wear an N95 face mask, don't travel, social distance, avoid large crowds, don't go indoors with people you're not sheltering with (especially in bars), practice good hand hygiene, and to protect your life and the lives of others, don't visit any of these 35 Places You're Most Likely to Catch COVID.

This article has been published in Yale's Medicine.

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