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Should we be drinking less?

Source: www.nytimes.com
Author: Anahad O’Connor

Can a daily drink or two lead to better health?

For many years, the federal government’s influential dietary guidelines implied as much, saying there was evidence that moderate drinking could lower the risk of heart disease and reduce mortality.

But now a committee of scientists that is helping to update the latest edition of the Dietary Guidelines for Americans is taking a harder stance on alcohol. The committee said in a recent conference call that it plans to recommend that men and women who drink limit themselves to a single serving of wine, beer or liquor per day. Do not drink because you think it will make you healthier, the committee says: It won’t. And it maintains that drinking less is generally better for health than drinking more.

That message is a departure from previous guidelines, which since 1980 have defined “moderate” drinking as up to two drinks a day for men and one for women. Government agencies have also long defined a standard drink as 12 ounces of regular beer, five ounces of wine, or one and a half ounces of distilled spirits (40 percent alcohol), amounts often exceeded in Americans’ typical “drink.”

Between 1990 and 2010, many editions of the guidelines, which are updated every five years, discouraged heavy drinking and warned pregnant women and people with certain medical conditions not to drink. But they also noted that moderate drinking was linked to fewer heart attacks and lower mortality. The 2010 guidelines mentioned that moderate drinking may even “help to keep cognitive function intact with age.”

The new recommendation would be a victory for experts who have long questioned the health halo around moderate drinking. They say that studies showing it can protect health are deeply flawed, and that any potential cardiovascular benefits would be outweighed by the fact that alcohol is a leading preventable cause of cancer. According to the National Cancer Institute, even one drink a day increases the risk of breast, esophageal and oral cancer.

“This is significant because the committee has finally gotten away from this idea that a small amount of alcohol is good for you,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America, a public interest group that has pushed for cancer warnings on alcohol. “They’re really taking a stand and saying drinking less is always better. That’s the right message and I think they deserve credit for making that change.”

The new advice is not yet final. The advisory panel is expected to include it in a report that it will release publicly in mid-July and submit to the Department of Agriculture and the Department of Health and Human Services. Those two agencies are scheduled to publish the official dietary guidelines later this year.

If accepted, the new recommendation would make the United States the latest country to issue stricter guidelines on alcohol consumption. In recent years, Britain, Australia, France and other countries have issued new guidelines lowering their recommended limits on daily and weekly alcohol intake. Health authorities in those countries have said that recent evidence suggests consuming less alcohol is safer and that even one drink a day increases cancer risk.

The scientific debate over moderate drinking dates at least back to the 1970s, when researchers in California noticed that teetotalers seemed to have more heart attacks than people who drank moderately. In the decades that followed, many observational studies looking at large populations documented what is known as a J-shaped curve between alcohol and mortality from all causes, especially heart disease: Mortality rates dipped for moderate drinkers compared to nondrinkers and then climbed higher among people whose intake exceeded one or two drinks daily.

But observational studies can show only correlations, not causation. And they have other limitations. One major confounding factor is that socioeconomic status is a strong predictor of health and life span — and it tracks closely with drinking levels. Studies show that compared to heavy drinkers and abstainers, people who drink moderately tend to be wealthier and have higher levels of education. They tend to have better health care, exercise more, eat healthier diets, and have less obesity.

One study that compared nondrinkers to moderate drinkers — defined as having two drinks daily for men and one for women — found that 27 out of 30 well established risk factors for heart disease were “significantly more prevalent” among nondrinkers. Rather than causing better health, in other words, moderate drinking may be a marker for higher socioeconomic status and other lifestyle factors that promote a longer life.

Another problem with observational studies is selection bias. In some large studies, people categorized as “nondrinkers” may actually be former heavy drinkers, or they may have health issues that cause them not to imbibe. Studies have found that nondrinkers have higher rates of physical disabilities, psychiatric problems and pre-existing illnesses. When rigorous studies take these factors into account, they find that the protective effect of moderate drinking disappears.

“The appearance of protection vanishes like the mist on an autumn day as the sun comes up,” said Timothy Stockwell, an alcohol researcher and director of the Canadian Institute for Substance Use Research at the University of Victoria. “All of these thousands of studies, when you do a forensic examination of them, most of them have these horrendous flaws and are open to these systematic biases.”

One way to get around these limitations is through genetic studies. Some people carry a genetic variant that disrupts their ability to metabolize alcohol, causing them to develop skin flushing, irritation and other unpleasant symptoms when they drink alcohol. As a result, they tend to abstain or drink very little. If alcohol was good for heart health, these people should in theory have more heart disease compared to others. Instead, as one large analysis published in BMJ in 2014 found, they have “a more favorable cardiovascular profile and a reduced risk of coronary heart disease than those without the genetic variant.”

The study concluded: “This suggests that reduction of alcohol consumption, even for light to moderate drinkers, is beneficial for cardiovascular health.”

Not everyone agrees that the health benefits of moderate drinking are illusory. Alcohol has blood-thinning properties, and red wine in particular contains polyphenols that have beneficial effects on the microbiome, said Dr. Erik Skovenborg, a family doctor and member of the International Alcohol Forum, an international group of scientists who study alcohol and health. Alcohol also raises HDL cholesterol, often referred to as the “good” kind, though recent studies have cast doubt on it being cardioprotective.

Dr. Skovenborg said the observational data makes it clear that moderate drinking is more than a marker for a healthy lifestyle.

“In these studies you have many participants that have all the healthy lifestyle factors,” he said, “and if you add moderate alcohol consumption on top of that, it increases the benefits regarding longer life and fewer health problems.”

Dr. Skovenborg said his general advice to patients who drink is to follow the Mediterranean tradition: Have a little wine with your meals, drink slowly, enjoy it, and don’t drink to get drunk. Exercise regularly, avoid smoking, eat nutritious foods, and maintain a normal weight. “It’s a pattern of things you should be doing, not just one thing,” he added.

Showing definitively that moderate drinking protects heart health requires doing a lengthy clinical trial, one that randomly assigns some people to have a drink daily and others to abstain. In 2014, the National Institutes of Health launched a clinical trial designed to do just that. But it was shut down in 2018 after a New York Times investigation revealed that N.I.H. officials had lobbied beer and liquor companies for funding and suggested that the results of the trial would support moderate drinking. As it turns out, experts have long raised concerns about industry influence on alcohol studies.

Members of the advisory committee declined to comment on their recommendations until their report is released. Dr. Stockwell said he agreed with the one-drink-a-day recommendation but he would word it slightly differently. “I’d probably say seven drinks a week for men and women and no more than two drinks on one day,” he said. “I would have a little flexibility.”

Surgery, radiation yield similar efficacy for early squamous cell carcinoma of lip

Source: www.healio.com
Author: Earl Holland Jr.

Both surgery and radiation therapy were beneficial methods of treating early-stage lip squamous cell carcinoma, according to findings presented at the American Academy of Dermatology virtual meeting.

Kevin Phan, MD, of the dermatology department at Liverpool Hospital, Sydney, Australia, and Mahmoud Dibas, MD, of Sulaiman Al Rajhi Colleges, College of Medicine, Saudi Arabia, sought to examine the survival rates in low-stage lip squamous cell carcinoma (SCC) between patients who had surgery alone and patients who had radiation therapy alone.

“Squamous cell carcinoma of the lip composes 25% to 30% of all oral cancers,” the authors wrote. “Lip SCC is often detected at an early stage, due to the highly visible location and slow growth pattern.”

Results from the Surveillance, Epidemiology, and End Results database between 2010 and 2014 were analyzed. Overall survival and cancer-specific survival were measured.

The researchers identified 900 patients with early-stage lip SCC who had received either radiation alone (36 patients) or surgery alone (864 patients).

Patients who underwent surgical procedures had better overall survival and cancer-specific survival rates compared with patients who had radiation alone, the study found. The treatment modality did not have a significant effect on either survival rate; the radiation-alone group had an adjusted hazard ratio of 1.94 (95% CI; 0.83-4.53), while the surgery-alone group had an adjusted hazard ratio of 1.04 (95% CI; 0.07-15.55).

“Our results support the notion that surgery and [radiation therapy] appear to be equally effective in treating early-stage lip SCC,” the researchers wrote.

Engineered killer immune cells target tumours and their immunosuppressive allies

Source: medicalxpress.com
Author: eLife staff

Scientists have engineered natural killer immune cells that not only kill head and neck tumor cells in mice but also reduce the immune-suppressing myeloid cells that allow tumors to evade the immune response, according to a new study in eLife.

The engineered cell therapy could be used as an alternative approach for treating cancer in patients for whom previous immunotherapy based on the activation of T cells has failed. These findings are reported by researchers at the U.S. National Institutes of Health (NIH) in Bethesda, Maryland.

In recent years, treatments called T-cell therapy or CAR-T cell therapy have been approved to treat blood cancers, and many others are now in development for other forms of cancer. However, these T-cell therapies rely on the ability to reprogram a patient’s own T cells to express a chimeric antigen receptor (CAR) that targets tumor cells. This process of reprogramming a patient’s own T cells is expensive and laborious.

High affinity natural killer cells (haNKs) represent potential ‘off-the-shelf’ cell therapies that do not rely on reprogramming a patient’s own immune cells. The same cells could be produced in mass and potentially given to anyone. But the presence of immune-suppressing myeloid cells in the tumor microenvironment remains a barrier to effective immunotherapy, including haNK cell-based treatment.

To address this barrier, researchers from the NIH’s National Institute on Deafness and Other Communication Disorders (NIDCD) and National Cancer Institute have utilized haNKs expressing a CAR that targets a molecule called programmed death ligand 1 (PD-L1). PD-L1 is a well-known culprit that cancer and immunosuppressive myeloid cells produce in high amounts to dampen down the immune system.

Led by senior author Clint Allen, Principal Investigator, Section on Translational Tumor Immunology, NIDCD, the team tested the engineered PD-L1 haNKs versus ordinary haNKs against human and mouse head and neck cancer cells. They found that the haNKs expressing the PD-L1 CAR kill mouse and human tumor cells to a greater degree than haNKs without the CAR, and that this ability was retained even if they had already been exposed to cells carrying PD-L1 before. This is important because natural killer cells are known to become ‘exhausted’ after killing target cells.

In mice with head and neck tumors, the haNK cell-based therapy cured the mice in 30% of cases and slowed the growth of tumors in the rest of the mice, without causing toxicity. Treatment with haNKs also reduced the numbers of immunosuppressive myeloid cells that carry PD-L1 within the tumor, while having no effect on other immune-boosting white blood cells.

To investigate whether this effect on the immune cells also occurred in patients, the team incubated white blood cells from people with advanced head and neck cancer with the PD-L1 haNK cells. As they saw in the mice, the immunosuppressive myeloid cells that carry PD-L1 were significantly reduced after treatment with the PD-L1 haNK cells. This suggests that this treatment can both directly kill tumor cells and remove the immunosuppressive myeloid cells that prevent conventional immunotherapies from working.

These findings suggest that haNK cells expressing a PD-L1 CAR may overcome some of the limitations of conventional immunotherapy that relies on T-cell activation, and could be used in patients who are predicted to be insensitive to or have failed existing immunotherapy treatments. The researchers say the next steps would be to take this treatment into the clinic to explore the safety of PD-L1 haNKs in people with advanced or recurring cancer, and to see whether combining haNK cell therapy with other immunotherapies that activate T cells can enhance treatment response.

E-cigarettes found to cause change in mouth bacteria – which could lead to gum disease or oral cancer

Source: theconversation.com
Author: Beth Daley

E-cigarettes are a popular alternative to smoking, but we still know very little about the effects of them on our health. While numerous studies have explored the effect of e-cigarettes on our lungs, heart, and overall health, one important and often overlooked consideration is what effect they have on our microbiome. But a recent study has found e-cigarettes change the bacteria in our mouths. These bacterial changes can lead to disease, if left unchecked.

Our microbiome is the living community of bacteria, fungi, and viruses that keep us healthy. We often hear a lot about our gut microbiome, but our oral microbiome is probably just as important to our overall health. It’s the second and most diverse microbiota next to the gut, home to over 1,000 species of microbes. It’s the gateway to the rest of our digestive system and plays a key role in helping us break down foods.

Our oral microbiome also wards off potentially harmful microbes by preventing them from reproducing. A healthy oral microbiome reduces the chances of developing infections or disease.

A recent study in Science Advances(1) investigating the effect of e-cigarettes on our oral microbiome found that e-cigarettes have a negative impact on the diversity of the bacteria present. They also cause an immune response from cells, which can lead to long-term damage to the surrounding cells.

Our oral microbes are not only the first to experience e-cigarette vapour, they’re also exposed to higher concentrations of the chemicals. This arguably makes them most likely of any of the body’s microbes to experience the negative effects of e-cigarettes. Changes in the balance of our mouth microbes can lead to some severe diseases, such as tooth decay and gum disease, or leave us susceptible to infections from localised gum disease that can trigger heart disease or respiratory infections or systemic infections like sepsis, which can be fatal. Some of these infections and diseases have also been associated with oral cancers.

For this particular study, 123 participants were recruited and split into five groups: smokers, non-smokers, e-cigarette users, former smokers currently using e-cigarettes, and those that use both. The team collected dental plaque samples to find out more about the microbes present and the genes they have, as well as fluid from the gums to know how the human body has reacted to these microbes. They also grew bacteria in the lab after exposing them to cigarette smoke and e-cigarette vapour.

Bacteria changes
The study found that those who used e-cigarettes had very similar species of microbes, suggesting e-cigarettes played a role in how the microbial community forms and exists. However, there were some significant differences in the smokers group, non-smoker group and e-cigarette groups, all of which had unique oral microbiomes.

When they looked at groups of people that switched from smoking to e-cigarettes and former smokers, they found their microbiota to be very similar – but they were still very different compared to non-smokers. Although this study didn’t specify which bacterial species were affected, even small changes from the healthy bacteria would likely result in negative effects overall. Gram negative bacteria, which are typically considered the “bad microbes”, were common between smokers and e-cigarette users.

This was also the case when the team did lab studies to see what effects e-cigarette vapour and cigarette smoke had on how bacteria grow. They found that the e-cigarette vapour (with or without nicotine) was able to change the way the bacteria grow, by increasing volume and the area covered by the bacteria, which can lead to infections if untreated.

The researchers also found that the microbes in the e-cigarette group had genes that lead to biofilm growth (such as dental plaque). Biofilms make microbes more resilient to the effects of drugs, toxic compounds and the immune system. This suggests that e-cigarettes vapours cause a stress response in the mouth’s microbes.

When stressed, microbes switch on their fight-or-flight genes, making them better able to survive in harsh environments. They do this by producing special enzymes that cause damage to other cells in order for the microbes to use their nutrients and get more space to reproduce. This leads to a cycle of more inflammation, causing a stronger stress response from other cells. However, if we can’t remove these stressed microbes, this sustained, long-term inflammation can lead to severe diseases.

It was also found that when e-cigarette users were compared with non-smokers, e-cigarette users had significantly higher levels of immune cell response chemicals than non-smokers. E-cigarettes users also had lower levels of chemicals that stop this stress response happening. This shows that the body is trying to fight off microbes present, much more so than in non-smokers.

The presence of a diverse microbiota is essential for healthy mouths, healthy bodies, and healthy people. But based on this study’s findings, the use of e-cigarettes has a negative impact on not only the number and types of oral microbes, but on how the microbes behave and how our body responds. Other studies have had similar findings. Though more research into the health effects of e-cigarettes is needed, current evidence suggests ditching them may be best for our overall health.

(1)Sukirth M. Ganesan et al, “Adverse effects of electronic cigarettes on the disease-naive oral microbiome”, Science Advances 27 May 2020: Vol. 6, no. 22,

Scientists to develop pain-free device to detect oral cancer

Source: www.expresshealthcare.in
Author: EH News Bureau staff

£1 million in funding has been awarded to the partnership to develop a functional prototype of a new device that uses Electrical Impedance Spectroscopy (EIS) technology for the early detection of cancerous lesions

In partnership with Zilico, the University of Sheffield is working to develop a pain-free, non-invasive and instantaneous method to detect oral cancer, A research collaboration has been awarded £1million in funding from SBRI Healthcare – an NHS England initiative – to test and develop a pain-free, non-invasive and instantaneous method to detect oral cancer.

Once built and tested, the new device could enable doctors to detect oral cancer earlier and more accurately, reducing the need for patients to have invasive biopsies. This, in turn, could provide better outcomes for patients and significant cost savings for the NHS.

The pioneering device is to be developed with medical device diagnostics company Zilico, born out of a partnership between the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust – using the same patented technology as its ZedScan device, which is now in use in the NHS for the early and non-invasive diagnosis of cervical cancer.

Researchers from the University of Sheffield and Sheffield Teaching Hospitals previously demonstrated that the principle of its electrical impedance spectroscopy (EIS) technology, where normal, precancerous and cancerous tissue can be differentiated according to its electrical properties could be useful for detecting oral cancer. The ‘proof of concept’ study involved 47 patients who were recruited from the Charles Clifford Dental Hospital.

Typically, suspicious oral lesions are inspected and diagnosed visually, but the visual indicators of the disease can be misleading or non-apparent in some cases. Many other signs and symptoms of mouth cancer such as constant bad breath and difficulty chewing or swallowing can also be caused by other things than cancer, so a definitive diagnosis can only be made through a biopsy of the tissue.

The new device could enable patients to receive a real-time diagnosis at the primary point of their care and the University is now working with Zilico to develop a functional prototype to be assessed and trialled for use in the NHS.

It is anticipated that the prototype will be ready for testing on a group of volunteers, with the aim to progress the project to a full clinical trial in the next 12 months.

Dr Keith Hunter, Professor of Head and Neck Pathology, at the University of Sheffield’s School of Clinical Dentistry and Insigneo Institute for in silico Medicine, said, “Mouth cancer is on the increase in the UK and globally, and we need new tools to be able to diagnose it earlier, as the survival rate for oral cancer patients depends on how early the disease is diagnosed and treated.

“Electrical impedance spectroscopy could help us to diagnose oral cancer earlier and more accurately, even when these cell changes may not be visually apparent. This could reduce the need for biopsies where there is no disease indicated – helping us to reduce patient anxiety and improve patient comfort.

“Hopefully developing less invasive techniques of diagnosing oral cancer will encourage more people to come forward with oral problems.”

Jamie Healey, Lead Clinical Scientist at Sheffield Teaching Hospitals NHS Foundation Trust, said, “We have collaborated with Zilico on the technology developments which form the basis of ZedScan for many years, and we are delighted to see that the clinical applications of electrical impedance spectroscopy are broadening, offering the potential for many more patients to benefit from this novel technology.”

To further the scientific evidence and applications for EIS to be used in diagnosing oral cancer, the collaboration has included a diverse range of University departments, including clinicians and researchers from Insigneo, the School of Health and Related Research (ScHARR) and the Department of Computer Science.

This research included Dr Dawn Walker and Dr James Heath from the Department of Computer Science developing cellular and tissue-scale finite element (FE) models to inform the classification of different tissue types based on EIS measurements collected from normal and diseased oral tissue samples.

Jim Chilcott, Professor of Healthcare Decision Modelling at ScHARR, said, “Using a whole disease modelling approach we are bringing together the available evidence on oral cancer diagnosis, management and treatment to optimise the design of the new oral device and underpin its diagnostic efficacy.”

“An EIS device for the diagnosing of suspected oral cancer has the potential to make an important contribution to the care and management of the disease, quickly removing uncertainty and anxiety for those without cancer and improving the journey to early treatment for those with cancerous and precancerous lesions, Chilcott added.

Aspirin against migraines and cancer

Source: www.swoknews.com
Author: staff

Aspirin never ceases to amaze us. For a medicine that has been around for over 120 years and remains one of the most inexpensive drugs in the pharmacy, we are surprised that there continue to be discoveries.

The latest review of aspirin has to do with its use in the prevention of migraine headaches (American Journal of Medicine, April 2020). One of the authors is Dr. Charles Hennekens. He is considered one of the world’s top scientists by his colleagues. He has contributed to three textbooks and over 750 medical publications.

Dr. Hennekens and his co-authors reviewed the aspirin data over the past several decades. They concluded:

“The totality of evidence, which includes data from randomized trials, suggests that high-dose aspirin, in doses from 900 to 1,300 mg, given at the onset of symptoms, is an effective and safe treatment option for acute migraine headaches. In addition, the totality of evidence, including, some but not all, randomized trials, suggests the possibility that daily aspirin in doses from 81 to 325 mg, may be an effective and safe treatment option for the prevention of recurrent migraine headaches.

“The relatively favorable side effect profile of aspirin and extremely low cost compared with other prescription drug therapies may provide additional clinical options for primary healthcare providers in the treatment of both acute and recurrent migraine headaches.”

Of course, no one should take high doses of aspirin without medical supervision. The same holds true for long-term use. Aspirin can cause stomach irritation and ulcers. And there is always a concern about bleeding.

New migraine medicines such as erenumab (Aimovig), fremanezumab (Ajovy) and galcanezumab (Emgality) could cost between $600 and $700 for a once-monthly injection. Health insurance may not always cover these new treatments. Bayer aspirin costs about 3 cents per pill.

What else can aspirin do? Surprisingly, many obstetricians now recommend aspirin for high-risk pregnancies (U.S. Preventive Services Task Force, Sept. 9, 2014). Low-dose aspirin, prescribed by a physician, may lower the risk of a serious condition called pre-eclampsia (Cochrane Database of Systematic Reviews, Oct. 30, 2019).

Most intriguing of all, aspirin continues to generate excitement with its anti-cancer activity. Scientists at Roswell Park Comprehensive Cancer Center have reported that patients taking low-dose aspirin have better survival statistics against head and neck cancer, as well as non-small-cell lung cancer.

There is also evidence to suggest that regular aspirin use reduces the risk of colorectal and other digestive tract cancers (Annals of Oncology, May 2020). Aspirin may also provide some protection against breast and prostate cancer.

Aspirin must be treated with respect because of the potential for serious adverse reactions. That is why a health professional should always monitor treatment and help weigh benefits and risks with this old OTC medication.

Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of King Features, 628 Virginia Drive, Orlando, FL 32803, or email them via their website:

FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

Source: www.statnews.com
Author: Matthew Herper

For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would.

Charles Rex Arbogast/AP

On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck.

The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list.

It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer.

“That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful for helping to inform the public that this serious disease, which has significant morbidity and mortality associated with it, can be prevented with the vaccine,” Lyman said.

Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades. He said he has “every expectation” that an HPV vaccine would reduce cancer rates.

The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials showing that the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions. But such lesions don’t exist in head and neck cancer, and it was not clear how to prove the vaccine’s efficacy.

Maura Gillison, now a professor at M.D. Anderson Cancer Center, first connected a subset of head-and-neck cancers to HPV in 1999. But then she and other epidemiologists noticed something: The number of head and neck cancers was rising rapidly, and HPV seemed to be a culprit. What’s more, these sexually transmitted cases seemed different — and somewhat easier to treat. The most common victims were middle-aged men who had contracted the virus decades before.

The FDA is granting what’s known as an accelerated approval, meaning that the decision is contingent on the production of more data and is based on what’s known as a “surrogate endpoint” — an indication that a medicine works that is not foolproof. In this case, the FDA is approving the drug based on data on preventing anogenital infection. In February, Merck began a study of 6,000 men that will test whether patients who receive the vaccine are less likely to get persistent HPV infections in their throats.

Adding another disease to the approval does impact what Merck can say to doctors and patients about HPV and head and neck cancer. “It’s something that was missing in the label,” said Alain Luxembourg, director, clinical research, Merck Research Laboratories. “It is something missing in the conversation between patients and doctors.”

Otis Brawley, an oncology and epidemiology professor at Johns Hopkins University, said that while he is usually opposed to surrogate endpoints, in this case he is comfortable with the decision. “There’s already enough reasons to vaccinate for HPV in men,” he said, adding that doing so broadly might make it possible to eradicate the virus, and the cancers it causes.

For Gillison, who spotted the emergence of HPV throat cancer, it came too late. She pushed Merck to do a study, and said that the one that started in February is coming “10 years plus after when it would have really mattered.” She also thinks that the real reason for the decision is the weight of epidemiologic evidence that she and others produced.

“The fact of the matter is that this approval probably has little whatsoever to do with the anal data per se,” Gillison wrote via text message. “It is because the FDA is made more comfortable with inference because of all the data that has been generated regarding the relationship between oral HPV infection and HPV vaccination outside of vaccine trials in the last 10 years.”

Fighting throat cancer with T cells

Source: www.miragenews.com
Author: press release, Centenary Institute

Research led by the Centenary Institute has discovered that immune cells accumulating within the tumor environment, called tumor-resident T cells, are a critical determinant in survival rates of patients suffering from throat cancer.

Reported in the prestigious ‘Journal for ImmunoTherapy of Cancer’, the research suggests that strategies aiming to boost these T-cells at tumor sites could be beneficial to patients.

“Oropharyngeal squamous cell carcinoma (OPSCC) is a form of throat cancer. It can be caused by environmental factors such as smoking or by human papillomavirus infection (HPV), the same virus that causes cervical cancer in women,” said Ms Rehana Hewavisenti, lead author of the study and researcher at the Centenary Institute and the University of Sydney.

“We knew that patients with HPV-related OPSCC had far better clinical outcomes compared to other OPSCC patients but we didn’t know why,” she said.

In examining over sixty patient samples, Ms Hewavisenti and her colleagues discovered that increased levels of tumor-resident T cells, whether in HPV or non-HPV OPSCC cases, was clearly associated with improved patient survival outcomes.

“It was the accumulation of these immune T-cells, in and around the tumour site that appeared to be key,” said Ms Hewavisenti.

The researchers also found in their study that HPV OPSCC patients generally had far higher levels of tumour-resident T cells compared to their non-HPV OPSCC patient counterparts.

“We think these HPV positive patients tended to have better clinical outcomes as HPV infection is likely to favor the accumulation of these beneficial T-cells within the tumor area,” she said.

Dr Mainthan Palendira, Head of the Centenary Institute’s Human Viral and Cancer Immunology Laboratory and senior author on the research paper believes the research findings have major implications.

“Now that we understand how important this immune response is in relation to OPSCC, we can begin developing new treatment strategies focused on recruiting these favourable tumor-resident T cells directly to tumors,” he said.

Dr Palendira believes that looking at the amount of these T-cells in cancer could help clinicians to personalize the best treatment approach for individual patients.

“We also think that our research demonstrating viral (HPV) links with this tumor-resident T cell accumulation could help in future cancer vaccine development efforts too,” he said.

These 4 diet and lifestyle changes can lower your cancer risk by almost 20%

Source: www.marketwatch.com
Author: Nicole Lyn Pesce

Bad news, booze and beef lovers.

The American Cancer Society has updated its diet and physical activity recommendations to help prevent cancer — and the new guidelines released on Tuesday discourage consuming red meat, processed food, sugar-sweetened drinks — and all alcohol.

The combination of these risk factors (as well as being physically inactive) accounted for at least 18.2% of cancer cases and 15.8% of cancer deaths in the U.S. in 2014, the American Cancer Society reported — making this unhealthy combo the biggest cancer risk factor after cigarette smoking in both men and women.

While the American Cancer Society has advised limiting the consumption of alcoholic drinks to no more to than one per day for women, and two for men since 2012, the new recommendations draw a harder line. “It is best not to drink alcohol,” it says. Period.

For people who still choose to imbibe, the revised guidance reiterates sticking to just one drink a day for women and two for men. And it should be noted that a standard single “drink” is defined as 12 ounces of regular beer, five ounces of wine, and a 1.5-ounce shot of distilled spirits or liquor, which may be smaller than what you actually pour yourself. For example, the University of Cambridge has noted that the average wine glass today holds 15 ounces — or three servings’ worth.

“That recommendation is the synthesis of the evidence and science that finds any amount of alcohol has been shown to increase cancer risk, including breast cancer,” Laura Makaroff, the senior vice president of Prevention & Early Detection at the American Cancer Society, told MarketWatch. “So the recommendation is to limit alcohol. It’s best not to drink, but if you choose to drink, do so in a moderate way.”

The American Cancer Society regularly revises its prevention recommendations, and the new updates are based on reviews of scientific research conducted by health organizations including: the International Agency on Cancer Research; the World Cancer Research Fund/American Institute for Cancer Research; and the U.S. Department of Agriculture and Health and Human Services. They were published in “CA: A Cancer Journal for Clinicians”.

Recent research has warned that many people may need to lay off the sauce. In fact, a recent National Institute on Alcohol Abuse and Alcoholism report found that the number of Americans drinking themselves to death has more than doubled over the last two decades. Alcohol was a factor in nearly 1 million deaths between 1999 and 2017. And multiple studies have suggested a link between alcohol consumption and cancer, including a 2019 report published in the journal BMC Public Health that warned drinking one 750-milliliter bottle of wine a week is associated with the same lifetime cancer risk as smoking five cigarettes a week for men, and 10 cigarettes for women. The National Cancer Institute has also reported “clear patterns” between alcohol consumption and developing head and neck cancer, esophageal cancer, liver cancer, breast cancer and colorectal cancer.

The new American Cancer Society guidelines aren’t just tough on alcohol, however. While they previously encouraged a plant-based diet that limited processed meat, red meat and refined grain products, and recommended maintaining a healthy weight, the new suggestions are much more specific. They include limiting or removing all red and processed meats, sugar-sweetened beverages, high-processed foods and refined grain products from your diet.

“Especially with colorectal cancer, there is an increased risk with people who choose to consume a lot of red meat,” said Makaroff.

Indeed, the World Health Organization’s International Agency for Research on Cancer (IARC) named processed meat a carcinogen in 2015, announcing it had found “sufficient evidence” that its consumption caused colorectal cancer. The IARC has also said that eating red meat is “probably carcinogenic to humans,” based on links to colorectal, pancreatic and prostate cancers.

Such diet and health concerns have helped fuel the growth of plant-based meat alternatives like those from Beyond Meat and Impossible Foods, which have brought their meat-like vegetarian patties to fast-food joints like the Restaurant Brands International chain Burger King. And sugar-sweetened beverages like sodas and sports drinks have been linked to early death, especially in women. Soft drink companies like Pepsi and Coca-Cola have started producing more low-calorie drinks like seltzers and bottled waters to appeal to more health-conscious consumers.

The American Cancer Society recommends piling your plate with a variety of whole, unprocessed foods and vegetables, instead. It highlights dark green, red and orange veggies in particular, as well as fiber-rich legumes like beans and peas. The guide also promotes whole grains, whole fruits in a variety of colors, and overall foods that are “high in nutrients in amounts that help achieve and maintain a healthy body weight.”

“The emphasis here is really about following a healthy eating pattern,” said Makaroff. “When you fill your plate with all of the good things — vegetables, fiber-rich legumes, whole fruits and whole grains — then you’re going to have less room for red and processed meat, which keeps them limited and in moderation.”

Physical activity guidelines have been pumped up, as well. While the American Cancer Society previously recommended engaging in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-activity each week, it now encourages adults to attempt doubling that. “Adults should engage in 150-300 minutes of moderate-intensity or 75-150 minutes of vigorous-intensity physical activity per week,” it reads, adding, “achieving or exceeding the upper limit of 300 minutes is optimal.”

Makaroff noted that reminders to stay active are vital during the coronavirus pandemic. “Many people generally lead a fairly sedentary lifestyle anyway, but then with COVID-19 and shelter-in-place orders, and all of these things we’ve recently gone through and are still going through, keeping an eye on our physical activity is maybe more important than ever, and making sure we are as active as we can be,” she said.

The American Cancer Society recommendations also recognize that access to whole, nutritious foods or safe places to exercise can be challenging for many people. Research suggests that racial inequality runs through education, health care, clean water and sanitation. “Your Zip Code matters a lot more than your genetic code,” said Makaroff. “The environments that we live, learn, work and play in are some of the biggest predictors of our overall health, which includes our risk of cancer.”

So the guidance also calls on public, private and community organizations to implement policy and environmental changes to: increase access to affordable, nutritious foods; provide safe, enjoyable, and accessible opportunities for physical activity; and limit alcohol for all individuals. “Those kinds of community actions are needed to be in place everywhere to help reduce systemic inequities,” said Makaroff.

Read the updated American Cancer Society guidelines in full here. And tips for adopting a healthier diet, squeezing in more exercise and losing weight can also be found in MarketWatch’s no B.S. guide to losing weight.

The American Cancer Society projects that 1.8 million people will be diagnosed with cancer in the U.S. this year. Cancer is the second leading cause of death in the U.S., according to the CDC, killing around 600,000 people a year. The No. 1 killer is heart disease.

And after fighting for their lives, many cancer survivors wind up fighting for their livelihoods. As new chemotherapy treatment and supportive drug-based treatment often tops $10,000 a month, almost one in four of America’s roughly 17 million cancer survivors struggle to pay their medical bills after treatment.

What’s more, an estimated 20% to 30% of survivors do not go back to work three to 18 months after diagnosis, according to the American Journal of Managed Care. And just 57% of low-income women kept their jobs after cancer treatment, compared with 90% of middle-income and 95% of high-income women

Dental record data analytics to improve oral health outcomes

Source: healthitanalytics.com
Author: Jessica Kent

A team from Regenstrief Institute and the Indiana University School of Medicine is applying data analytics techniques to previously inaccessible dental record information with the goal of improving oral health outcomes.

Researchers assessed de-identified data from electronic dental records (EDRs) of 217,887 patients of 99 solo or small dental practices across the US. These EDRs included more than 11 million observations, with observation periods as long as 37 years.

Information on demographics, reason for visit, medical and dental history, social history, tooth characteristics and treatment, and practice and practitioner characteristics was collected for each patient visit.

Dentists could share their data for research in an anonymized process with the help of their EDR vendor. Data from two EDR systems with different formats and operating systems were combined, where interoperability has previously proved difficult with medical data.

Additionally, the study looked at the oral health and treatment options of both insured and uninsured patients, in contrast to previous studies which have relied on insurance records and haven’t provided any information on uninsured patients.

The group found that it was possible to mine and utilize massive amounts of dental record data to determine which dental therapies work and which don’t, which could lead to quality improvement from individual dentists. The study showed that EDR data is reliable for purposes beyond clinical patient care.

Dental practitioners can learn from aggregated data across practices and compare their practice with their peers, researchers said. Information collected at each patient’s visit can contribute to improved outcomes and the development of a true learning health system. This study is the largest to evaluate data quality in a regular patient setting.

“Here in the real world of the dentist’s office we are seeing patients with all kinds of real-world conditions – pain, underlying medical conditions, lack of adequate past oral health care — so this large data set provides a unique insight into the treatments offered in the type of dental offices where most Americans receive care,” said Dr. Thyvalikakath, the founding director of Regenstrief-IU School of Dentistry dental informatics program.

Past research has shown that evaluating dental record data from both insured and underinsured individuals can help inform care delivery and expose gaps in oral care.

A 2019 study showed that racial minorities, lower-income individuals, and uninsured or publicly insured patients were significantly less likely to report that they had received screenings for oral cancer, revealing glaring disparities in oral healthcare.

Investigators can examine this real-world data to better understand the quality of care delivered to patients in different populations.

Now that they have completed the proof-of-concept, the Regenstrief and Indiana School of Medicine team will leverage the data to assess the long-term effectiveness of two common dental procedures performed on permanent teeth: root canal therapy and tooth-colored teeth fillings in rear teeth.

This part of the study will determine how well and how long root canal treated teeth and back teeth filled with tooth-colored fillings continue to function. Data analysis for this portion of the study will help dentists and patients make evidence-based care decisions. Data analysis is currently nearing completion and the researchers will publish their findings in the future.

“Findings derived from patient data in real-world conditions is typically less difficult for clinicians to translate at the point of care than studies performed in large health systems which often represent a patient population that does not mirror the community dentists see in their practices,” said Thyvalikakath.

“We are presenting a mechanism for dentists, many of whom practice by themselves or with only one or two others, to learn from their own experience and from the experiences of their peers to assist in improving skills and facing problems.”