U.S. FDA removes clinical hold on CEL-SCI’s phase 3 head & neck cancer trial

Source: www.businesswire.com
Author: press release

CEL-SCI Corporation today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company’s Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume.

Multikine is being studied as a potential first-line (before any other cancer treatment is given) immunotherapy that is aimed at harnessing the patient’s own immune system to produce an anti-tumor response. Nine hundred twenty-eight (928) newly diagnosed head and neck cancer patients have been enrolled in this Phase 3 cancer study and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol.

The study’s primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus standard of care (SOC) versus those who receive SOC only. The determination if the study’s primary end point has been met will occur when there are a total of 298 deaths in those two groups. Current SOC for this indication is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy.

There is a clear and unmet medical need for a new treatment in this indication as the last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago. The FDA has also designated Multikine an Orphan Drug for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN).

About Head and Neck Cancer
Head and neck cancer describes squamous cell carcinomas located inside the neck, mouth, nose, and throat. According to the World Health Organization, the annual incidence of head and neck cancer is approximately 550,000 cases worldwide, with about 300,000 deaths each year. Risk factors involved with head and neck cancer include heavy alcohol use, tobacco use, and the cancer causing type of human papilloma virus (HPV).

About CEL-SCI Corporation
CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

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August, 2017|Oral Cancer News|

A Guide On How To Fight Your Outrageous Hospital Bill (And Win)

Source: www.huffingtonpost.com
Author: Gemma Hartley
Date: 8/4/2017

My medical bill nightmare started out fairly normally. My toddler fell and hurt her wrist. Since she has a flair for the dramatic, she let her wrist flop, looking broken as she screamed in agony. My husband and I examined her wrist and couldn’t figure out how serious the situation was, so we played it safe and took her to the emergency room. She had a mild sprain, it turned out. She was in and out ― no medication, no nothing.

I knew there would be an obscene bill for taking her to the ER, but I had no idea just how shocking it would be. When I received the bill for my daughter, I seriously hoped that something was amiss. The amount was nearly $800 (which was more than we could afford at the time), and before insurance it had been nearly $3,000.

Could the bill really be that huge for a 15-minute visit? I couldn’t fathom it, so I requested an itemized bill ― a habit I picked up after hearing horror stories of new mothers being charged outrageously in labor and delivery. An itemized bill almost always contains errors, which is why I wasn’t about to pay a penny before carefully looking over my daughter’s charges.

There were a couple of small errors, such as overpriced medicines she didn’t receive, but it wasn’t the $14 aspirin hiking up her bill. I called the hospital to ask about my daughter’s charge entry, which was was outlandishly high, nearly $2,600 of the $3,000 total bill. The woman in the billing office told me that charge entry levels were codes used to determine the severity of cases entering the ER. They will dictate what reimbursements the hospital should receive, and they are entered in by the doctor. And as for mistakes in charge entry levels? They aren’t uncommon.

“We see the same issue not just in the ER, but in other areas of the hospital (and even in an office setting),” said Sean McSweeney, president of Apache Health, a medical billing company for clinics and hospitals. “These issues are often unintentional, but are simply the result of a doctor trying to quickly code and move on.” However, McSweeney also says this process can be tampered with. Providers can check boxes for procedures as simple as reviewing medical history or spending extra time with the patient. These things have the potential to kick up the charge entry coding level.

My daughter was billed as Level 3 (out of 4) for a barely perceptible sprain. The woman I spoke to advised that I call the emergency physician’s office. It felt like I was being given the runaround, but calling turned up some interesting information.

I discovered the charge entry level the doctor put in didn’t match what the hospital put in. (Still, the doctor coded my daughter’s visit as Level 2, which left me wondering what on Earth a Level 1 visit looks like.) I also did a bit of sleuthing and found that putting in a higher entry level, known as upcoding, can drastically hike up ER bills. While I didn’t realize it at the time, it’s illegal.

Fixing the error, however, was not as easy as simply pointing it out. I had to have the bill suspended, which involved sending a dated, signed letter to the hospital requesting the information be re-examined. The bill showed up again. The hospital claimed to have never received the letter, so I sent another. I spent hours on the phone being shuffled between the billing office, the physician’s office, and at one point the bill was even sent to collections, who called relentlessly, nonplussed by my claim of errors in the medical billing process.

I also did a bit of sleuthing and found that putting in a higher entry level, known as upcoding, can drastically hike up ER bills. While I didn’t realize it at the time, it’s illegal.

The fight to reconcile this error turned into a two-year battle, culminating in the bill being discarded because of the number of errors the hospital made throughout the process. Throughout the saga I kept a careful paper trail, noting each date I received a bill, whom I spoke with on the phone, what next steps had been suggested and taken. I reported the hospital to the Better Business Bureau, which was another waste of my time (medical providers have terrible ratings, but also don’t have competition).

I eventually began recording the calls, making it known to the person on the other line and mentioning upcoding each time I called. It was only at the point when I revealed I had recorded evidence and a paper trail that the hospital decided to write off the charges.

I wish I had known from the start how to handle erroneous charges on high medical bills. Had I known to use the word “upcoding” in my first conversation with the billing department, I might have saved hours spent on the phone. Fortunately, I kept careful records, which gave me the upper hand, but I shouldn’t have spent two years of stressful fighting when they were so clearly in the wrong. Had I known the ramifications of upcoding, I would have reported them to my insurer and had them investigated for fraud.

The fight against medical fraud

Organizations like the Nation Health Care Anti-Fraud Association (NHCAA) are working to crack down on medical fraud to ensure that insurers and patients aren’t footing the bill for medical providers who bend the facts ― and the government is behind them. The Justice Department participated in the government’s largest health care fraud takedown in U.S. history last month, in which 412 defendants, including 56 doctors, were charged with scamming American taxpayers out of more than $1 billion in opioid-related abuses.

“The vast majority of health care providers are honest and do what they need to do for their patients, but it only takes a small number to really have a negative impact on the entire system,” NHCAA CEO Louis Saccoccio told Fox News in an interview following the takedown.

Upcoding isn’t a mistake that simply makes you pay more (even though that’s enough to make you go red in the face with rage). It can permanently mess with your medical records when your information is incorrectly recorded. If you are upcoded in a way that indicates you have a medical problem that doesn’t exist, it could cost in a lot more than a big bill in the long run ― making you look like more of a liability to insurers. The opposite can be equally damaging, as in the 1995 case of a Brooklyn doctor in New York who performed brief medical reviews (instead of the full physicals she billed for), which resulted in multiple patients being wrongfully denied Social Security disability benefits over the course of four years.

While the Affordable Care Act made it illegal to deny a patient coverage based on pre-existing conditions, congressional Republicans have been consistently battling to erode the ACA and its protections. If you are erroneously charged for a health condition you don’t have because of upcoding, it could affect your ability to get health care coverage.

It’s crucial to spot these medical bill errors and remedy them immediately. If you don’t, it could cost you now and later.

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August, 2017|Oral Cancer News|

Cancer is a fungus’?! We need to get serious about evidence-based treatment

Source: http://www.telegraph.co.uk
Date: August 3rd, 2017
Author: Judith Potts

Over the last few years I have come across myriad myths about cures for breast cancer – indeed all cancers.  Of course, everyone is looking for a treatment which does not involve chemotherapy, a diagnostic test which does not use radiation, or a treatment without side effects.

While thermography may be an innovative concept, there is little good evidence that it is effective in detecting breast cancer at an early stageEluned Hughes, head of public health and information at Breast Cancer Now

But I have lost count of the number of times I have heard that ‘Cancer is a fungus and Sodium Bicarbonate is the cure’.  I have even been sent an amateur video of a man mixing his sodium bicarbonate potion in an extremely unhygienic-looking  kitchen. Part of the Cancer Research UK’s website carries ‘10 Persistent Cancer Myths Debunked’ which makes an interesting read –  . Alternative therapies abound and all are described as ‘natural’.

The word is applied to food, to beauty products and to fabrics – but, all too often, the list of ingredients denies the description. Last week, an email dropped into my inbox introducing me to Dr Nyjon Eccles and describing his work at his clinic in London’s Harley Street – The ‘Natural’ Doctor.  Was it referring to his treatments as being ‘natural’ in the sense of pure, unadulterated and complementary, or did he mean that he was born a ‘natural’ doctor?

I discovered that Dr Eccles is offering a breast cancer screening clinical test called ThermoCheck, a computer-assisted thermography which is ‘a 15 minute, painless, non-invasive, state of the art clinical test without any exposure to radiation’.  Dr Eccles believes the test can be used on women as young as 20 and it will “identify metabolic changes in the tissue and is a much earlier indicator of breast health compromise than traditional mammograms”.

He says that thermography may identify pre-cancerous changes; thermography, the website script goes, “looks for physiological irregularities, whereas mammography looks for anatomical irregularities.  The infra-red camera takes thermal images of the breasts which show a heat map of the surface of the skin detecting any metabolic changes and signs of abnormal blood vessels- which give off more heat than the surrounding tissue – at an early stage, possibly 6-10 years before a tumour is big enough to be seen on a mammogram.”

Needless to say, there is a price to this test – the initial breast thermography and consultation (up to 90 min) is £395, with a breast thermography scan (up to 30 mins) at £245. Added to this is Dr Eccles’ Breast Nutricheck, which is a home test kit which ‘identifies several nutrients that seem to impact on breast tissue health’. This costs £425.

With so much written about breast cancer, particularly about the genetic varieties, I am concerned that many women (I note that men are not included) – particularly the young – may be persuaded to undertake this test on a regular and expensive basis.  So I turned to Breast Cancer Now to find out whether or not thermography was an accepted and proven way to detect early breast cancer.

It seems to me that not enough has been done to compare thermography to mammography with ultrasound

Eluned Hughes, head of public health and information at Breast Cancer Now told me: “While thermography may be an innovative concept, there is little good evidence that it is effective in detecting breast cancer at an early stage – let alone that it could replace traditional mammography.  Any new screening test would need to demonstrate even greater sensitivity than mammography, as well as better accuracy in detecting breast tumours and distinguishing between cancerous and healthy cells.  Unfortunately, there is currently no evidence to suggest that thermography is capable of either.”

This lack of evidence has led to the Royal College of Radiology, the Royal Australian and New Zealand College of Radiologists and The American Society of Breast Imaging specifically not endorsing the process.

One of the concerns raised is that women who undergo thermography may delay visiting their doctor with a significant symptom, or attending for screening, if they believe that thermography is an adequate replacement for a visit to the GP or a mammogram.

I brought these concerns to Dr Eccles, who said that thermography has been shown to have a better sensitivity for detecting existing cancers than mammography, and that the variable results may be because “some thermographic studies have not used accepted standardised protocols.”

Arguing that thermography should be offered by doctors alongside other structural scans, he told me: “It is simply not true that there is no evidence for thermography’s usefulness. It time for doctors to make honest and correct statements about mammography screening based on the latest evidence – i.e. the risks outweigh the benefits. Thermography is at the very least, a valuable non-invasive adjunctive tool to identify women at risk and help detect pre-cancerous changes in the breast. If used correctly, it has the potential to help us significantly reduce breast cancer incidence.”

Studies continue to be conducted in the USA to explore the potential of infrared imaging of the breast, but it seems to me that not enough has been done to compare thermography to mammography with ultrasound, breast MRI, or nuclear imaging. One day there might be and perhaps the results will vindicate Dr Eccles but, until we can be assured that thermography will give an accurate diagnosis, please remember that if you have a family history of breast cancer, regular screening or other interventions can be offered by the NHS at a younger age than the 49-50 age group at which invitations for mammograms arrive.

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August, 2017|Oral Cancer News|

No HPV Vaccination for Boys in UK

Source: Peter Russell
Date: July 20, 2017
Source: www.medscape.com

Health bodies are condemning a decision not to include boys in the human papilloma virus (HPV) vaccination programme as “shameful” and a “missed opportunity”.

The Joint Committee on Vaccination and Immunisation (JCVI) has concluded that it “did not recommend vaccinating boys at this time as it was considered unlikely to be cost-effective”.

Girls aged 12 to 13 have routinely been offered the HPV jab since September 2008 as part of the NHS childhood vaccination programme.

The JCVI has been considering whether to include boys on the scheme since 2014.

Protection Against Some Cancers

HPV is the name for a group of viruses that are most commonly passed on through genital contact between straight and same-sex partners.

It is a very common infection. Almost every sexually active person will get HPV at some time in their lives.

Most people who get HPV never develop symptoms or health problems, but for some it can lead to cancer of the cervix, vulva, vagina, penis, anus, and head and neck, as well as cause genital warts.

According to health professionals, the virus has been linked to 1 in 20 cases of cancer in the UK.

Campaigners in favour of giving boys the jab argue that HPV does not discriminate between the sexes and that offering the vaccine to boys in school would save lives.

‘Few Additional Benefits’

The JCVI has decided that a high take-up of the vaccine among girls would provide ‘herd protection’ to boys, and that vaccination of boys “would generate little additional benefit to the prevention of cervical cancer, which was the main aim of the programme”.

Additionally, the committee found insufficient evidence that the jab would protect against cancers affecting males such as anal, head and neck cancers. However, it agreed to keep evidence under review, particularly for men who have sex with men.

‘An Astonishing Decision’

Several health bodies have issued statements criticising the JCVI’s decision. The Faculty of Sexual and Reproductive Healthcare says it’s a “missed opportunity” and is urging it to reconsider its stance in October after a period of public consultation. Peter Baker, HPV action campaign director, says: “It is astonishing that the government’s vaccination advisory committee has ignored advice from patient organisations, doctors treating men with HPV-related cancers, public health experts and those whose lives have been devastated by HPV.

“The interim decision not to vaccinate boys is about saving money not public health or equity.”

Dentists are also condemning the decision. Mick Armstrong, chair of the British Dental Association, says: “HPV has emerged as the leading cause of oropharyngeal cancers, so JCVI’s unwillingness to expand the vaccination programme to boys is frankly indefensible. The state has a responsibility to offer all our children the best possible defence.

Dentists are also condemning the decision. Mick Armstrong, chair of the British Dental Association, says: “HPV has emerged as the leading cause of oropharyngeal cancers, so JCVI’s unwillingness to expand the vaccination programme to boys is frankly indefensible. The state has a responsibility to offer all our children the best possible defence.

“Dentists are on the front line in the battle against oral cancer, a condition with heart-breaking and life-changing results. Ministers can choose to sit this one out, or show they really believe in prevention.”

‘Shameful’

Emma Greenwood, Cancer Research UK’s director of policy, comments: “We’re disappointed to hear that the JCVI has made an interim recommendation not to offer the HPV vaccine to boys. If boys were included in the vaccination programme, it would help reduce the risk of HPV related cancers for the whole population, compared to vaccinating girls alone.”

The Terrence Higgins Trust describes the JCVIs decision as “shameful”. Its chief executive, Ian Green, says: “A gender neutral policy on HPV vaccination is long overdue and would protect boys from cancers caused by untreated HPV, including penile, anal and some types of head and neck cancer.”.

Jonathan Ball, professor of molecular virology at the University of Nottingham, says: “As increasing numbers of girls take up the vaccine then risk of heterosexual transmission decreases and the benefit of vaccinating boys diminishes.

“But of course, this reliance on herd immunity doesn’t provide optimal benefit for boys who go onto have sex with other men in adulthood.  There is a pilot vaccination programme running for men who have sex with men, but not all men at risk are likely to enrol in this, and we know the vaccine is most effective before someone becomes sexually active.

Limited Health Resources

“Unfortunately, it isn’t a question of science – it’s one of cost – and at the moment the Vaccination and Immunisation Committee doesn’t consider that the benefits are worth the investment.”

Dr David Elliman, consultant in community child health, adds: “Although it always seems hard to have to consider cost, it is important to make sure that we spend the money available to the NHS in a way that gets us best value.”

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August, 2017|Oral Cancer News|

Transoral robotic surgery cuts patient recovery time

Source: exclusive.multibriefs.com
Author: Carolina Pickens

Oral cancer is diagnosed in almost 50,000 Americans each year and has a 57 percent survivability rate past five years, according to research from the Oral Cancer Foundation.

3D illustration of surgical robot

The number of diagnoses has been fairly constant in oral and pharyngeal cancer for decades, but survivability has actually gone up slightly in the last 10 years. This can be attributed to the increasing percentage of patients with dental insurance attending annual appointments (when oral cancer is most often recognized and diagnosed earlier), the spread of HPV-related oral cancer (which is easier to treat) and advances in diagnostic tools for dentists and oral specialists.

These advancements aren’t limited to recognizing oral and throat cancer; strides in scientific approaches for surgical treatment are changing the way specialists treat oral phalangeal cancers. For example, Nepean Hospital of New South Wales has seen drastic improvement in patients’ quality of life and surgical recovery time by performing transoral robotic surgery (TORS) with the da Vinci System.

This technology provides surgeons the tools needed to perform successful, minimally-invasive surgeries for patients with T1 or T2 throat cancers.

“Without the robot, tongue and throat cancers are among the most difficult tumors to surgically remove,” said Dr. Chin, an otolaryngology, head and neck surgeon at the hospital.

Previous surgical methods required surgeons cut into the neck to access tumors in the throat and back of the mouth — and operations would often last for up to 12 hours at a time. This caused permanent scarring and required recovery time in ICU and months of physical or occupational therapy for patients to learn to talk and eat again.

TORS grants surgeons the ability to operate intraorally, reducing time spent on the operating table down to merely 45 minutes. Surgeons get a 3-D view of the tumor and a high-definition picture of the mouth and throat with this high-tech equipment — this also greatly reduces the likelihood parts of a tumor go unseen and remain in the body post-surgery.

A surgeon, who stays in control of the robot 100 percent of the time, then uses instruments on his or her own wrists to guide the robot during each step of the surgery. The TORS rotation is also far greater than that of a human wrist — granting the ability to access parts of the patient’s throat previously unreachable with conventional surgery.

As noted in Dentistry Today, this minimally-invasive technique has patients eating within 24 hours and cuts recovery time in the hospital from weeks to two days. Patients are able to maintain their independence post-surgery. This is revolutionary for older patients, for whom complicated surgeries often cause a decrease in their overall quality of life.

As more surgical practices obtain this valuable technology, oral and dental specialists expect to see more improvements in survivability rates for patients with pharyngeal and oral cancers.

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Cancer-patient advocacy group says ‘Fight cancer, not me’

Source: www.news4jax.com
Author: staff

Many patients fighting cancer are also battling insurance companies’ policies and processes that make it difficult or even impossible to receive proton radiation therapy that their doctors prescribe, according to the advocacy group Alliance for Proton Therapy Access.

Believing patients should be able to receive quick answers and fair treatment from insurance companies when faced with a cancer diagnosis, the group has started a campaign, “Tell Insurers: Fight Cancer, Not Me,” and a petition drive.

“All cancer patients deserve access to the best available cancer treatment recommended by their physicians,” the group wrote on its website. “Too many patients, however, experience insurance company delays and denials when their doctors recommend proton therapy. Proton therapy is an advanced form of radiation therapy that offers patients fewer side effects and improved quality of life.”

Kathy Brooks has worked in oncology nursing for more than 30 years, and at Ackerman Cancer Center since 2015, so she understands exactly how difficult cancer treatment can be. When she was diagnosed with tongue cancer in 2016, she knew she needed proton therapy.

“Because of my experience as an oncology nurse, I knew that treatment for head and neck cancer is very difficult,” said Brooks. “Proton therapy was my best chance to survive and have quality of life, but unfortunately my insurance did not approve it. Going forward with my proton treatment, I had to fight the cancer and deal with the insurance appeals process every step of the way.”

The Alliance is asking people to sign its online petition at AllianceForProtonTherapy.org/take-action.

Ackerman Cancer Center will host an awareness day on Wednesday

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Calgary cancer patient asks why smokers are near hospitals if grounds are supposed to be ‘smoke-free’

Source: globalnews.ca
Author: Heather Yourex-West

At just 47-years-old, Tim Allsopp is battling throat cancer. He doesn’t smoke but during he’s his treatment, he says, he’s been exposed to second-hand cigarette smoke more often because he often passes by people smoking on his way to treatment at Calgary’s Tom Baker Cancer Centre.

“Everyday when we come to therapy, we notice that there’s people smoking outside the building,” Allsopp said. “That’s confusing to me because the policy states, no smoking on Alberta Health Services property, this includes buildings, grounds and parking lots.”

“I’m at the point now where I’m very susceptible to infection and that could land me in the emergency department in almost life threatening condition.”

While AHS has had a smoke-free hospital grounds policy for years, it doesn’t take long to spot people lighting up. AHS says it tries to enforce its policy, but it’s not easy.

WATCH: Smokers ignore no smoking signs in front of Winnipeg hospitals

“Our protective services people try to use an educational approach first but if that’s not successful, then they have the power to issue a ticket,” said Dr. Brent Friesen, lead medical officer of health for Alberta Health Services’ tobacco reduction strategy.

Friesen says the problem is that AHS can only issue tickets for people breaking either provincial law or city by-law, not AHS policy. That means, while AHS may say no smoking is allowed on hospital grounds, the province only requires people keep a five-metre distance from hospital doors.

“If they’re further than five metres away, the option that’s available for our protective staff is to charge the person with trespassing but that’s a cumbersome approach in terms of having to get a court order and it (also) starts to raise concerns in terms of what implications that might have for that individual, if they want to seek care in the future.”

It’s a similar situation for hospitals across the country. Provincial rules in B.C. require smokers keep a distance of six metres from hospital entrance ways, in Winnipeg eight metres is required and Ontario and Quebec require nine metres between hospital doors and anyone lighting up. Next year, however, Ontario will become the first province to ban smoking entirely on hospital grounds. Anyone caught violating the rule could face a $1,000 fine.

Friesen says Alberta Health Services would like Alberta’s provincial government to follow Ontario’s lead but Alberta health minister, Sarah Hoffman, says patients who are addicted to nicotine deserve compassion as well.

“I think its challenging who are living in hospital who may be in difficult health situations -maybe even at end of life – and to ask them to quit at that point would be very challenging for them but we do need to make sure that if they are going to be using substance that they do so without impacting other patients and staff.”

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Head and neck cancer is more common than you think

Source: www.irishtimes.com
Author: Jamie Ball

Well over 1,000 people in Ireland are diagnosed each year with cancers of the head and neck, with almost three-quarters of cases being attributed to smoking and alcohol. Yet this pernicious form of cancer very often goes under-reported, or sufficient heed isn’t paid to the warning signs that, if caught early, may be the difference between life and death.

This is why July 27th will mark the third World Head & Neck Cancer day, taking place across 53 countries. The 2017 National Cancer Strategy highlights the importance of prevention, detection and diagnosis, and education and awareness is key for early recognition of the disease.

According to James Paul O’Neill, Prof of Otolaryngology, Head and Neck Surgery in Beaumont Hospital, Dublin and the Royal College of Surgeons in Ireland, there can be many different types of cancers within the head and neck, each with their own tissue characteristics and biological behaviour.

“Cancers may develop in several areas of this region, including the mouth, throat, larynx (voice box), glandular tissue (thyroid), salivary tissue (parotid gland), lymphatic tissue, nose, sinuses and skin. Patients have a large variety of symptoms and signs according to the subsite of the disease,” says O’Neill.

He says surgery incorporates many different techniques and skills, as the region has essential functional roles, such as talking, breathing, smelling, hearing, chewing and swallowing.

“We are now in the age of highly-specialised technological innovations. There is a drive towards minimally invasive surgery because we can perform the same surgery except with reduced morbidity to surrounding structures.

“Chemotherapy overall offers little in head and neck oncology, with an overall survival difference of approximately 6.5 per cent, but a hike in morbidity of nearly 50 per cent.

“Overall, some head and neck cancers have an excellent prognosis, but unfortunately two-thirds of all our patients present with advanced disease at the time of diagnosis. If these patients fail our first line of therapy, their prognosis is often very challenging. Head and neck cancers often advance quickly and given the anatomical complexity of the region, frequently impinge on or directly invade the patient’s airway,” says O’Neill.

Following a diagnosis of Laryngeal cancer in 2014, Sligoman Donal Connor had his larynx removed in Beaumont Hospital, under the care of Prof O’Neill and plastic surgeon Barry O’Sullivan. Despite his diagnosis, Connor had never smoked, and remained fit and active all his life.

“This was life-changing surgery, but it gave me a chance to have a life and get rid of this tumour, which was making me hoarse and very unwell,” says Connor. “I now have a little prosthesis, or speaking valve, in my neck, which helps to project my voice. I have to put my finger in the hole in my neck, which is called a stoma, every time I want to speak, which can be very tiring. Conversation for me is the biggest challenge, as I cannot raise my voice if I need to call someone, and I cannot speak over the radio, television or in a crowded situation,” says Connor.

“I now breathe through the stoma, which must be cleaned and cared for on a daily basis, and so it’s much easier for me to get chest infections. I understand my neck looks different and people stare at it, but by now I’m used to this type of attention.”

Connor says his sense of smell has been impacted hugely, while going for a swim is no longer an option either. “If water enters my stoma it would flood my lungs. I have to take great care in the shower. My stoma needs to be covered at all times around water. I am very lucky I can eat and drink most things, but I have to relax after my meals or my food will repeat on me. I cannot speak during mealtimes as I need to focus on swallowing.

“Regardless of all these negatives, I am thankful to God every day to be cancer free and given this second chance. I could go around all day depressed, and some days I do, but I try my best to make the most out of the life I have been left with,” says Connor.

“I know I had different treatments and surgeries that weren’t successful for me, but what didn’t work for me may be very successful for other cancer patients, as everyone’s cancer is different. I know now that anyone who is hoarse for more than six weeks should have it investigated. Please go to your GP, or further if needs be, and have it checked out. It may be nothing to worry about, but if it is detected early, its half the battle.”

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The Bogus Medicines the Feds Have No Plan to Stop

Source: http://www.thedailybeast.com/the-bogus-medicines-the-feds-have-no-plan-to-stop
Date: July 22, 2017
Author: Paul A. Offit

In a better world, the FDA would regulate homeopathic products. It would certainly be a lot cheaper and just as effective.

Homeopathic products are big business, grossing at least $3 billion a year. A 2007 survey estimated that 3.9 million adults and 910,000 children used them. These figures have only increased during the past 10 years.

One uncomfortable fact about homeopathic products, which are substances meant to treat patients by mimicking the symptoms of an illness, is that the Food and Drug Administration (FDA) doesn’t regulate them. This means that:

  • Manufacturers are not required to submit a new drug application before selling them.
  • Manufacturers are exempt from meeting Good Manufacturing Product (GMP) standards.
  • Manufacturers are exempt from finished-product testing for identity and strength.
  • And, as an added bonus, homeopathic products are allowed to contain higher amounts of alcohol than other drugs.

Because no one is looking, poorly made and dangerous products slip through. In 2012, for example, 10,000 cases of “poison exposures” were reported; most occurred in children who were less than five years old and some required medical treatment.

For these and other reasons, the FDA held a meeting on April 20 and 21, 2015, to discuss the regulation of homeopathic products. The FDA sought “written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.” With so many competing interests in the room, it shouldn’t be surprising that nothing happened. Nonetheless, about a year and a half after the FDA meeting, on Nov. 15, 2016, the Federal Trade Commission (FTC) took a stand, declaring that homeopathic products cannot include claims of effectiveness without competent and reliable scientific evidence. If no evidence existed (which is always the case), this fact must be clearly stated on the label.

In order to understand homeopathic products and the controversies that surround them, we need to go back to the beginning.

Homeopathy was the creation of Samuel Hahnemann, who practiced in Germany and France between 1779 and 1843. Hahnemann was disturbed by the brutality of 19th-century medicine, which included bloodletting, leeches, emetics, cathartics, and skin blistering with acids. He wanted a safer, better way to treat his patients.

Hahnemann’s epiphany came in 1790. While eating powder from the bark of a cinchona tree, Hahnemann developed a fever. At the time, it was known that cinchona bark, which contained quinine, could treat malaria. Hahnemann believed that because cinchona bark had caused him to have fever, and because fever was a symptom of malaria, medicines should induce the same symptoms as the diseases they were treating. For example, vomiting illnesses should be treated with medicines that cause vomiting. (Homeopathy literally means “similar suffering.”) To be on the safe side, however, Hahnemann also believed that homeopathic medicines should be diluted to the point that they aren’t there anymore. Although the active ingredient was gone, Hahnemann believed that the final preparation would be influenced by the fact that the medicines had once been there. In other words, the water in which the product was diluted would remember. (Given the finite amount of water on earth, it’s comforting to know that it doesn’t actually remember where it’s been.)

To understand how homeopathic products are made, let’s look at one popular product made by Boiron, a French company that describes itself as a “world leader in homeopathic medicines.” The product is called Oscillococcinum.

Boiron makes Oscillococcinum by homogenizing the heart and liver of a Burberry duck, diluting it in water 100-fold, and then repeating the hundred-fold dilution 200 more times. A solution this dilute doesn’t contain a single molecule of the Burberry duck. In fact, the preparation is so dilute that not a single molecule of the duck would be found if the final volume were that of the universe (about 1080 cubic meters). The duck is gone. From a scientist’s standpoint, Oscillococcinum is one gram of sugar. Nonetheless, a pack containing six “doses” of Oscillococcinum costs $8.00. So it’s really expensive sugar.

The label for Oscillococcinum claims that it “reduces the duration and severity of flu symptoms,” including “body aches, headache, fever, chills, and fatigue.” At the end of these claims is a small superscripted asterisk that refers the consumer to an equally small statement on the back of the box: “These ‘Uses’ have not been evaluated by the Food and Drug Administration.”

Promoters of Oscillococcinum argue that the product is of value if only because it’s a lot safer than other remedies out there, many of which are quite harmful. For example, some doctors will prescribe an antibiotic, like the all-too-conveniently-named Z-Pack, which contains azithromycin. Antibiotics can cause allergic responses or select for resistant bacteria. Worse, some parents will use over-the-counter cough-and-cold preparations. In 2007, the FDA issued a warning against these preparations in young children—a warning long overdue. Between 2004 and 2005, the CDC found that more than 1,500 young children had suffered hallucinations, seizures, and heart problems caused by cough-and-cold medicines containing stimulants like pseudoephedrine. Three children died as a result. Further, these products do little to relieve symptoms. Oscillococcinum, on the other hand, doesn’t cause any of these side effects.

When people suffer adverse reactions to homeopathic products, like the poisonings referred to above, it’s because they aren’t really homeopathic. In other words, they might contain an active drug. Because homeopathic products aren’t regulated, consumers are on their own.

The worst aspect of homeopathic products is when people use them to treat conditions that should be treated with real drugs, like antibiotics for bacterial infections or bronchodilators for asthma or steroids for severe eczema. Or, as was the case for a 45-year-old woman named Penelope Dingle in Australia, chemotherapy for a treatable cancer. Dingle paid for her choice with her life.

In a better world, the FDA would regulate homeopathic products. Manufacturers would have to meet labeling and manufacturing standards and products would have to be proven to be safe and effective before they could be sold. If this happened, homeopathic products would disappear from the shelves. Then, patients or parents would have to use their own water or sugar to treat themselves and their children. It would certainly be a lot cheaper and consumers can be reassured that it would be just as effective.

Paul A. Offit, MD, is director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and the author of Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine (HarperCollins, 2013).

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July, 2017|Oral Cancer News|

Teens drink less if they know alcohol causes cancer — but most don’t — study finds

Source: http://www.adelaidenow.com.au/
Author: Tim Williams, Education Reporter

Teens are less likely to drink if they know that alcohol is a major cause of cancer, but most are unaware of the link, a South Australian study has found. More than 2800 school students aged 12-17 were surveyed about their drinking behaviour by Adelaide University and South Australian Health and Medical Research Institute (SAHMRI) researchers.

Those aged 14-17 were deterred from drinking if they knew about the link between alcohol and cancer, but only 28 per cent of students were aware of the connection. Parental disapproval was another deterrent, while smoking and approval from friends resulted in higher rates of drinking. Most students had tried alcohol by age 16 and a third drank at least occasionally. Wealthy students were more likely to drink.

Cancer Council SA chief executive Lincoln Size said there was clear evidence drinking caused cancers of the mouth, pharynx, larynx and oesophagus, as well as bowel cancer in men and breast cancer in women. It likely raised the risk of liver cancer and bowel cancer in women too.

“Any level of alcohol consumption increases the risk of developing an alcohol-related cancer; the level of risk increases in line with the level of consumption,” he said.

“This latest evidence highlights the need to educate young people about the consequences of alcohol consumption and for parents to demonstrate responsible drinking behaviour.

“We need to get the message through that what may be considered harmless fun actually has lifelong consequences.”

Lead author Jacqueline Bowden, a behavioural scientist with both the uni and SAHMRI, said drinking patterns were often set in adolescence.

“With alcohol contributing to four of the top five causes of death in young people, and a leading cause of cancer in our community, it’s important for us to better understand drinking behaviour among young people so we can help to prevent or delay it,” Ms Bowden said.

“One of the major messages from our study is that parents have more influence on their teenagers’ decisions regarding alcohol than they probably realise.

“Parental behaviour and attitudes towards alcohol really do make a difference, and can help prevent children from drinking at an early age.

“Many parents believe providing their children with alcohol in the safe environment of their home teaches them to drink responsibly.

“However, the weight of evidence suggests that this increases consumption, and is not recommended.

“Our results also found that those adolescents who thought they could buy alcohol easily were more likely to drink regularly. The issue of availability — including price — and marketing of alcohol in the community is a major hurdle to be overcome.”

The findings of the study, which was supported by Cancer Council SA and the State Government, have been published in the journal BMC Public Health.

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