Monthly Archives: April 2021

From curing herpes to treating diabetes in a new way, their innovations might one day treat some of the worlds most prevalent health problems. This years two finalists in STAT Madness, a bracket-style competition that showcases cutting-edge research across the biomedical sciences, harnessed new approaches to devise possible therapies that could help millions of people with all-too-common maladies.

One team, from the Fred Hutchinson Cancer Research Center, developed a gene-editing technique with the potential to effectively treat and even cure herpes. The other finalist, a group from the Massachusetts Institute of Technology and Brigham and Womens Hospital, devised a liquid solution that coats the small intestine with a temporary adhesive, a noninvasive technique with wide applications from efficient drug delivery to treating diabetes.

The competition was stiff, with well over 1 million votes cast during the month-long contest, blowing past last years record of almost 700,000 votes. In the end, both teams were declared winners. STAT editors made that decision in the interest of fairness, after identifying unusual voting patterns in the final round.

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Martine Aubert, Keith Jerome, and their colleagues at Fred Hutch tested a new method of gene therapy to treat herpes, improving on previous research done by Jerome. Using gene editing in mice, the researchers removed over 90% of the virus from the cells that it mainly infects, they reported in a paper published in Nature.

Jerome, a virologist and a professor at Fred Hutch and the University of Washington, said that after years of improving their gene editing approach, he was more thrilled than surprised about the promising results. Thats what we were going for, he said.

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Existing antiviral treatments for herpes typically address the infection temporarily, but latent virus still remains in the body, hiding in the peripheral nerves and periodically reactiving. Type 1 HSV usually causes cold sores around the mouth and lips; type 2 causes sores on the genitals. Herpes is incredibly common, affecting over two-thirds of people under age 50 worldwide. In their study, the researchers tested their treatment for the type 1 virus, but think it would also be effective for type 2.

In previous research, Aubert and Jerome had found that using a DNA-clipping enzyme called meganuclease, they could effectively target viral DNA in infected cells and damage the herpes virus. The enzymes used in the research were delivered to cells via a hollowed-out virus-like particle, called a viral vector. In the Nature study, the researchers also experimented with other gene-editing approaches, such as CRISPR/Cas9.

You can see some signs [CRISPR/Cas9] was working a bit, but the meganucleases were way, way better, said Jerome.

Several incremental improvements to the researchers original method enabled it to destroy almost all of the herpes virus in the peripheral nerve cells of mice, versus damaging 4% or less of the virus in the initial study.

In the new paper, the researchers hypothesized that if the technique works in humans, it would reduce viral shedding, which would make it harder to transmit the virus to others. In recent research, the researchers have further supported this idea using a mouse model Aubert developed that mimics viral shedding in humans. There were also some signs the technique could be improved upon even further, making it possible for it to effectively cure herpes.

There might be a tweak in there [that would explain] why some animals do better than others, said Aubert. For instance, some mice had no detectable disease at all.

It may take at least two-and-a-half years before the treatment enters human trials, said the researchers. They are planning to meet with the Food and Drug Administration by this summer to discuss what safety data they will need to collect before beginning a clinical trial. The researchers also said the technique might eventually be used to treat hepatitis B and HIV.

The other winning team was led by Junwei Li, a researcher at Brigham and Womens Hospital and a visiting scientist at MIT. The researchers developed a solution that, once inside the small intestine, undergoes a reaction and coats it with a temporary adhesive. Giovanni Traverso, an assistant professor of mechanical engineering at MIT and a gastroenterologist at Brigham and Womens Hospital, was the senior author of the study published in Science Translational Medicine.

Li said that using the coating to make drug delivery more efficient was one of the researchers main goals. Some drugs are metabolized quickly and largely go to waste before the body absorbs all the medication, he said. The coating would slow absorption of a drug, the researchers reasoned. The technology could not only make drugs more effective, said Li, but less expensive.

If we can increase this [absorption] by, for example five times, then you can lower the cost by five times, he said.

The solution is mainly made up of dopamine, which exists commonly in the body as a neurotransmitter. Once the dopamine enters the small intestine, it reacts with an enzyme called catalase in the intestinal lining. The reaction creates an adhesive polymer that temporarily coats the small intestine with a kind of molecular glue.The coating can stay there for 24 hours, which really maximizes the absorption window, Li said.

The small intestine is where most nutrients and also drugs are absorbed by the body, and also where the highest concentration of catalase is found. Because of this, the researchers found that the dopamine would not form a coating in areas they werent targeting, like the stomach. They tested the method in human and pig tissue in the lab, and also in live pigs, whose GI tracts are similar to those of humans. The solution was delivered into the pigs through a tube, but the researchers envision that patients would be able to drink it or swallow it as a pill or capsule.

In a series of experiments, the researchers investigated potential applications of the solution. In one, they found that the drug praziquantel, which treats the tropical, parasitic disease schistosomiasis, lasted far longer in pigs when combined with the solution. Praziquantel is normally taken three times a day, so using this technique could help decrease the dosing frequency.

Li and his team also found that in pigs, the solution created a more effective way to deliver the enzyme lactase to the digestive system, which could help lactose intolerant people, and that the coating decreased the speed at which glucose was absorbed, which could provide an alternative treatment for people with diabetes or obesity.

Safety testing of the solution in pigs and rats did not find any concerns.

The two teams emerged triumphant from nearly 130 submissions to STATs contest, out of which 64 entries were selected for the bracket. The submissions came from across the country and were selected based on scientific rigor, originality in their field, and potential impact.

Jerome is grateful for the large community who supported his teams research on social media, many of whom have herpes. He said he has also enjoyed looking at all the competitors research projects.

Ive learned a lot, he said.

Li said he enjoyed the engagement with his teams research and learning about other teams studies. While some of the students in the lab were quite invested in the competition, Li said he was never especially attached to winning. He sees the competition as being about exposing people to and engaging with exciting new research. He also said the competition was a welcome distraction and a way to connect with other researchers in a time of social isolation.

It was really fun, especially during quarantine, said Li.

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Research on therapies for herpes and diabetes win STAT Madness - STAT - STAT

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Dr Paul Chrisp, director of the Centre for Guidelines at NICE, said: We want this guideline to make a positive difference to people with chronic pain, and their families and carers.

It highlights that achieving an understanding of how pain is affecting a persons life and those around them and knowing what is important to the person is the first step in developing an effective care and support plan that recognises and treats a persons pain as valid and unique to them.

Pain that lasts for more than 3months is known as chronic or persistent pain. In the UK the prevalence of chronic pain is uncertain, but appears common, affecting perhaps one-third to one-half of the population. The prevalence of chronic primary pain is unknown but is estimated to be between 1 and 6% in England.

Chronic pain that is caused by an underlying condition (for example, osteoarthritis, rheumatoid arthritis, ulcerative colitis, endometriosis) is known as chronic secondary pain. Where the cause of the pain is unclear it is called chronic primary pain. Although the NICE guideline covers the assessment and development of a care and support plan for all types of chronic pain, it focuses on treatments for chronic primary pain. Pain management as part of palliative care is not covered in the guideline.

The guideline emphasises the need for shared decision making, putting patients at the centre of their care, and fostering a collaborative, supportive relationship between patients and healthcare professionals. It highlights the importance of healthcare professionals gaining an understanding of how a persons life affects their pain and how pain affects their life, including their work and leisure time, relationships with family and friends, and sleep.

The guideline recommends that a care and support plan should be developed based on the effects of pain on day-to-day activities, as well as a persons preferences, abilities and goals. It also highlights the importance of being honest with the person about the uncertainty of the prognosis.

The guideline makes recommendations for treatments that have been shown to be effective in managing chronic primary pain. These include exercise programmes and the psychological therapies CBT and acceptance and commitment therapy (ACT). Acupuncture is also recommended as an option.

People with chronic primary pain should not be started on commonly used drugs including paracetamol, non-steroidal anti-inflammatory drugs, benzodiazepines or opioids. This is because there is little or no evidence that they make any difference to peoples quality of life, pain or psychological distress, but they can cause harm, including possible addiction.

The guideline does recommend that an antidepressant can be considered for people aged 18years and over to manage chronic primary pain, after a full discussion of the benefits and harms. This is because the evidence shows antidepressants may help with quality of life, pain, sleep and psychological distress, even in the absence of a diagnosis of depression.

Dr Chrisp added: This guideline is very clear in highlighting that, based on the evidence, for most people its unlikely that any drug treatments for chronic primary pain, other than antidepressants, provide an adequate balance between any benefits they might provide and the risks associated with them.

But people shouldnt be worried that were asking them to simply stop taking their medicines without providing them with alternative, safer and more effective options. First and foremost, people who are taking medicines to treat their chronic primary pain which arent recommended in the guideline should ask their doctor to review their prescribing as part of shared decision making. This could involve agreeing a plan to carry on taking their medicines if they provide benefit at a safe dose and few harms, or support for them to reduce and stop the medicine if possible. When making shared decisions about whether to stop it's important that any problems associated with withdrawal are discussed and properly addressed.

Nick Kosky, a consultant psychiatrist at Dorset HealthCare NHS University Foundation Trust and chair of the guideline committee said: Understandably, people with chronic pain expect a clear diagnosis and effective treatment. But its complexity and the fact GPs and specialists alike find chronic pain very challenging to manage, means this is often not possible.

This guideline underlines the importance of appropriate assessment, careful drug choice, exercise programmes, psychological therapies, and consideration of acupuncture in improving the experience and outcomes of care for people with chronic pain.

Lucy Ryan, a patient representative on the guideline committee, said: This guideline will provide more consistency in treatment and support on the NHS for people experiencing chronic pain. I am pleased that it has highlighted the potential risks of some of the drugs used to treat chronic primary pain as I feel people are sometimes not made aware of these. I am also pleased that the guideline provides alternative treatment choices and that gaps in research have been identified. I hope that this will mean future guidelines will incorporate many more options for people managing chronic primary pain following further research. Everyone with chronic pain experiences pain differently so I feel the more options available to help people effectively manage their pain the better.

NICE is also producing guidelines on shared decision making and the safe prescribing and withdrawal management of medicines associated with dependence or withdrawal symptoms; these are expected to be published in June 2021 and November 2021 respectively.

See more here:

NICE recommends range of effective treatments for people with chronic primary pain and calls on healthcare professionals to recognise and treat a...

10th of April is celebrated as World Homeopathy Day to make the immense contribution of homeopathy to medicine, all around the world.

This day is observed on the birth anniversary of the founder of homeopathy, Dr Christian Friedrich Samuel Hahnemann who was a German-born in Paris on April 10, 1755.

Dr Hahnemann, a distinguished scientist and scholar discovered the way to heal through the use of homeopathyand his discovery, as well as methods, continue to serve humanity as a plausible complementary or alternative medicine.

As a complementary or alternative medicine, homeopathy is different from treatments that are part of conventional western medicine in many ways. A central principle of the treatment is that like cures like that a substance that causes certain symptoms can also help to remove it.

Just like many other branches of medicine, homeopathy has faced criticism in the past and continues to face the same today, however, its usage across the world is growing with prominent figures such as Queen Elizabeth II and her successor-Prince Charles being users and benefactors of this form of alternative medicine.

In 2007, Prince Charles wrote to the then-health secretary of the UK-Alan Johnson complaining that people were suffering unnecessarily as a result of the ministers anti-homeopathy campaign. In his letter, Charles stated, inter lia, that homeopathy offers an holistic, patient-centred, low-risk, low-cost, low-tech approach and that for all these reasons it must surely make abundant sense to safeguard the HHs [homeopathic hospitals] in the interests of the nations health.

In March 2020, it was reported that Queen Elizabeth, 94 years, continues to rely on homeopathy to keep her well during the coronavirus outbreak. The Queens mother, who lived to 101 was also said to be a fan of homeopathy.

If the royal family of Great Britain and over 100 million people in India solely depend on homeopathy for their medical care as well as over 100 million citizens of the European Union use homeopathic medicines, then surely its acceptance and growing popularity in Ghana was inevitable.

In celebrating homeopathy today, its journey and now prominence in Ghana is worthy of reminiscing. The early practitioners such as Dr Adu Boateng whose End Point Homeopathic Clinic is a front industry runner in Ghana faced several obstacles (from individual acceptance to regulatory issues) during the introduction of this form of alternative medicine to the mass market in Ghana over a decade ago.

Of course, there were people practising homeopathy in Ghana before I entered into practice over 10 years ago with End Point Homeopathic Clinic. However, these pioneers where practising a bit of everything in the sector of alternative medicine. Most of them had herbal medicine as their main area but delved into homeopathy too, Dr Adu Boateng in an interview stated.

He continued: It was a relentless struggle those days and it seems because a sole homeopathic practice was not in existence, the necessary regulatory framework was not developedso all these had to come into force gradually and instituted by the government for us to get to where we are today as a country that has somewhat widely accepted homeopathy.

With 5 branches across Ghana, Dr Adu Boateng and his End Point Homeopathy Clinic have successfully trained several homeopaths who have also established their clinics in Ghanafurthering his ultimate desire to bring homeopathy to the front doors of millions of Ghanaians.

End Point Homeopathy Clinic

Commenting on the growth and acceptance of homeopathy and the future of alternative medicine in Ghana, Dr Adu Boateng stated that it is refreshing to see more practitioners of homeopathy providing quality healthcare services in Ghanabut what is even more gratifying is the fact that treatments are working and more people are relying and trusting this form of alternative medicine.

However, he cautioned the general public against patronizing the practices of non-quality and unqualified practitionerssaying, there are a few people who as would be expected of any industry are doing anything and calling it homeopathy.

When it comes to a persons health, it cannot be played with, therefore, Ghanaians should make sure that they are only using well established and trustworthy homeopathic clinics to ensure that they receive the deserving healthcare, Dr Boateng said.

In celebrating this years World Homeopathy Day, End Point Homeopathy Clinic is offering free prostate screening for menand free fertility testing for women at all its branches across Ghana for the month of April.

Source: Ghanacelebrities.com

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World Homeopathy Day: Celebrating The Leading Fathers Of Homeopathy In Ghana - Peace FM Online

The MHRA is committed to speeding up access to innovative new medicines for patients. The Early Access to Medicines Scheme (EAMS) gives patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The scheme has remained fully operational throughout the coronavirus (COVID-19) pandemic, ensuring that patients with serious conditions can still be offered new treatment options for their conditions.

As an example, the MHRA issued a positive scientific opinion for Roches atezolizumab (Tecentriq) in a new combination regimen for patients with unresectable hepatocellular carcinoma (HCC) in June 2020. Atezolizumab is a monoclonal antibody that directly binds programmed death-ligand 1 (PD-L1). PD-L1 may be expressed on tumour cells and/or tumour-infiltrating-immune cells and can contribute to the inhibition of the anti-tumour immune response in the tumour microenvironment.

Through EAMS, MHRA has been able to work with Roche since 2017 to ensure that over 600 UK patients with limited treatment options, have been among the first in the world to benefit from 8 breakthrough treatments prior to licence. This has paved the way for accelerated routine access in the NHS. To date, this working collaboration between MHRA and Roche has represented roughly a quarter of all EAMS run in the UK, including patients benefiting from receiving Tecentriq in five new cancer indications.

Cases of primary liver cancer are rising in the UK. HCC is the most common form of primary liver cancer and tends to be diagnosed at an advanced stage, often in cirrhotic livers, when very limited treatment options are available. For these patients, there is a high unmet need for alternative treatment options as their prognosis is poor, with rapid progression and short overall survival.

Roche benefitted from the MHRA validating the evidence generated at an early stage during the first step of the EAMS, the PIM (Promising Innovative Medicine) designation. The PIM designation gave an early indication from the MHRA that atezolizumab in combination with bevacizumab, was a potential candidate for EAMS. This enhanced opportunities for Roche to work with other stakeholders in the UK around patient access. Subsequently, Roche presented their positive Phase III clinical data at a pre-submission meeting with MHRA. This provided the company with an opportunity to discuss the dossier of evidence and consider data collection aspects with the MHRA in advance of a formal application. At this point, the MHRA recommended Roche submit an application for step II of EAMS, the Scientific Opinion (SO). During the SO assessment, the MHRA fully assessed the data generated for atezolizumab to ensure that the EAMS criteria were met and the benefits outweighed the risks. A resultant positive SO was issued.

There often is a time period between granting of a marketing authorisation (when EAMS closes) and NICE reimbursement, during which new patients may be unable to access the innovative medicine. Following a partnership between Roche, NHS England and NHS Improvement and the MHRA, the first Post-EAMS pilot was created to enable new patients to gain access to atezolizumab and bevacizumab during this time period.

During the EAMS period, 63 patients with HCC were able to access atezolizumab (in combination with bevacizumab) after discussions with their doctor. Submission through EAMS accelerated patient access to the treatment by around 4 months.

The Post-EAMS pilot has enabled Trusts in England to order medicine for patients using the same processes that were used for EAMS, saving capacity and NHS resources. During the relatively short duration of this pilot, 13 more eligible HCC patients were able to access treatment with atezolizumab and bevacizumab.

Tecentriq, in combination with Avastin, is now the first cancer immunotherapy treatment recommended by NICE for HCC.

Milestone dates include:

The IMbrave150 trial was published in New England Journal of Medicine in May 2020 and established the superiority of atezolizumab and bevacizumab for advanced hepatocellular carcinoma compared to the existing standard of care. The Roche EAMS allowed us to offer this new standard of care to our patients within 8 weeks of the publication and the Post-EAMS pilot facilitated seamless transition to NHS provision.

The close collaboration between Roche and regulators has enabled the translation of research, partly conducted in the UK, into patient benefit with minimal delay and great efficiency.

Roches EAMS journey with atezolizumab (in combination with bevacizumab) is a good example of the NHS continuing to support patient access to innovative treatment throughout the coronavirus pandemic.

Thanks to the partnership working between Roche, NHS England and NHS Improvement, and the MHRA, access continued through the Post-EAMS pilot, allowing clinicians to choose this treatment to support their patients and demonstrating the potential for this collaborative approach to be expanded for an enhanced EAMS programme.

Raising awareness of EAMS, especially during the coronavirus pandemic is important to ensure patients with high unmet medical needs such as these HCC patients, do not miss out on potentially life-changing new treatments.

The MHRA and Roche have been steadfast in their commitment to the assessment of the EAMS Scientific Opinion, ensuring no delay to early access for HCC patients even amidst all the challenges presented by the pandemic.

The addition of the Post-EAMS pilot to EAMS demonstrates that UK health agencies in collaboration with industry partners may be able to feasibly offer a more streamlined process to enable equitable early access to innovative treatments in the UK. Learnings from this pilot will help to refine the process for future EAMS programs.

EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Visit EAMS to find out more.

You may also find help to expedite your medicines to patients by visiting the MHRA Innovation Office which provides free and confidential expert regulatory information and advice. Find out more about how the innovation office has helped support innovation; read our case studies.

Read more:

Early Access continues during the coronavirus (COVID-19) pandemic - GOV.UK