cancer

The burden of cancer isn’t just cancer

Source: www.news.doximity.com
Author: Carolyn Y. Johnson
 

Money is low on the list of things most people want to think about after a doctor says the scary word “cancer.” And it’s not just patients — physicians also want to weigh the best treatment options to rout the cancer, unburdened by financial nitty gritty. But a growing body of evidence suggests that, far from crass, ignoring cost could be harmful to patients’ health.

In the age of $10,000-a-month cancer drugs and health plans that shift more of the cost of health care onto patients, research suggests we’ve been underestimating one of cancer’s real harms: “financial toxicity.”

The financial difficulties that stem from dealing with cancer can lead people to avoid or delay care or drugs, studies suggest, and also may cause stress that can lead to mental and physical health problems.

“When people are diagnosed, it behooves the provider to assess their financial risk at baseline — to find out if they’re at risk, and if they are, to be very aggressive with getting them to financial planning, to patient assistance programs to reduce their likelihood of having financial devastation,” said Scott Ramsey, a health economist and physician at the Fred Hutchinson Cancer Research Center in Seattle who showed in 2013 that people with cancer are 2.65 times more likely to file for bankruptcy than people without cancer. “We think unless you do, it’ll be hard to keep people from ending up in this situation.”

For years, the evidence has accrued that cancer patients experience greater financial challenges than other groups of sick people. A study in the Journal of Clinical Oncology found that 13 percent of non-elderly patients with cancer spend at least a fifth of their income on treatment. Among people on Medicare, cancer patients spent an average of $4,727 of their own money on health care, according to a 2013 Cancer study — about $1,000 more than people without cancer.

What has been far less clear is whether the distress is simply a financial problem or also a health issue. No one would say financial stress is desirable, but does it affect how long or well cancer patients lived? Were people skipping doctor’s visits, drugs or other treatments?

There’s some evidence that higher co-pays deter patients from filling their prescriptions — one study found that a copay of about $50 a month or more was enough to keep nearly a fifth of patients from continuing to fill prescriptions for a remarkably effective rare leukemia treatment.

But cancer’s burden isn’t just high drug costs. Last month, Ramsey and colleagues reported that not only are cancer patients more likely to declare bankruptcy than those without; those who declared bankruptcy were 1.8 times as likely to die of any cause than cancer patients with the same diagnoses and initial treatments who did not.

Another study published in the journal Cancer last month examined Medicare data and found that among nearly 20 million cancer survivors, 29 percent reported financial burden of some kind, ranging from bankruptcy to borrowing money to not being able to pay for medical visits. Among those reporting financial burdens, 86 percent had health insurance during their cancer treatment.

“Another thing that concerns me with the way most insurance policies are set up is it seems they do a good job of protecting you at sort of middle-range expenses, but if you get to really high expenses, people incur a lot of out-of-pocket costs. The thing you want insurance to insure you against is financial catastrophe, but the way these policies are set up, for a lot of people, they don’t,” said Norman Carroll, a professor of pharmacoeconomics and health outcomes at the Virginia Commonwealth University School of Pharmacy who led the Cancer study.

How financial toxicity hurts

The big question underlying this research is how financial distress hurts and what should be done about it. Are patients skipping appointments and not taking drugs that could extend their lives because they’re going broke? Or are they losing their jobs or earning less after cancer and is worry about going broke having a snowball effect, bringing on other ill health effects?

There aren’t definitive answers, but worrisome hints.

A 2013 study published in The Oncologist found that nearly half of cancer patients with insurance surveyed cut back on their spending on food and clothing or dipped into savings to pay for their treatment. The majority cut back on leisure activities. Three-quarters of them received financial assistance with their drug copayments.

A study of Medicare beneficiaries in the Journal of Managed Care Pharmacy found that for expensive cancer drugs that are given as pills, patients were more likely to stop or delay drug therapy as the portion they paid increased. For every $10 increase in out of patient costs per month, the likelihood of stopping or delaying use of the drug increased — 12.7 percent for a leukemia drug called imatinib.

Add to that Carroll’s recent study, which found cancer patients who reported three or more financial problems had clinically meaningful differences in physical health. The study also tracked depression, and people with any kind of financial burden had meaningful differences in mental health — and as the number of financial problems increased, so did the mental health burden.

“Physicians probably should focus more on shared decision-making with patients to the extent that’s possible, and spend more time than I think has been spent in the past to see if you can find equally effective, lower cost treatment,” Carroll said.

But researchers still don’t know enough about the problem — or what the best therapy is. Ramsey said he is now working on a pilot where financial information will be collected at oncology clinics when people are seen, to see how treatments affect patients’ financial health in real time.

“It’s easy for me to say that, but it’s hard to really do, because doctors don’t really want to deal with it, patients don’t want to,” Ramsey said

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Why a Cure For Cancer Is Possible

Source: www.fortune.com
Author: Robert Mulroy
 

BERLIN, GERMANY - SEPTEMBER 05:  A doctor holds a stethoscope on September 5, 2012 in Berlin, Germany. Doctors in the country are demanding higher payments from health insurance companies (Krankenkassen). Over 20 doctors' associations are expected to hold a vote this week over possible strikes and temporary closings of their practices if assurances that a requested additional annual increase of 3.5 billion euros (4,390,475,550 USD) in payments are not provided. The Kassenaerztlichen Bundesvereinigung (KBV), the National Association of Statutory Health Insurance Physicians, unexpectedly broke off talks with the health insurance companies on Monday.  (Photo by Adam Berry/Getty Images)

Cutting drug prices is not out of the question.

A crapshoot is defined as a risky or uncertain matter; something that could produce a good or bad result. President Obama’s moonshot on cancer is different in terms of its greater complexity and higher moral purpose — but unfortunately, not in its probability of success.

The Audacity of Scope

President Obama has asked Congress for $755 million to “focus” on immunotherapy, combination therapy, vaccines that prevent cancer causing viruses, and early detection techniques. According to Vice President Joe Biden, who will coordinate 13 government institutions in this research, “Our job is to clear out the bureaucratic hurdles, and let science happen.”

It is hard not to welcome such an initiative. Cancer has deposed heart disease as the number one killer in 22 American states. Experts project the number of global cancer cases will double in the next 15 years. But we are better at projecting the demand for innovation than we are at producing it; and we are even better at making promises we can’t keep and polices that don’t work.

President Roosevelt created the National Cancer Institute in 1937. Nixon declared a “war on cancer” with the National Cancer Act in 1971. The Bush administration spoke in 2003 of spending $600 million per year to rid the world of cancer by 2015. Obama and Biden made campaign promises to fight cancer in 2008, and should be lauded for trying to keep them, but their approach needs a lot of work.

The underlying assumption is that we should spend as much money, and use as many public and private constituencies to do as much as we can on as many paths as possible. There are three things wrong with this: first, $755 million is a measly sum under the current paradigm drug development. It can cost a company up to $5 billion and a full decade to bring one cancer-fighting drug to market. Second, we have tried this strategy before. Doing the same thing again, only harder, will lead to numerous failures whose cost will be passed on to the insurance companies and their customers in the form of high drug prices. Third, the answer is right in front of us.

We use the term moonshot to reference JFK’s successful space program, but don’t apply its deepest insights. We in the cancer fighting community lack that program’s predictive models, which were the key to its success. Despite severe technological limitations, NASA believed in predictive models based in math, engineering and physics. They modeled, for example, gravity’s influence on earth launches, moon landings, and human tissue. The models told them exactly what tools were needed to do the job. Only then did they build spacecraft to accomplish our goals.

Meanwhile, back on earth, we build tools before we understand the problem of cancer. Two-thirds of published research cannot be reproduced. In the post-genomic era, the FDA approves only 7% of drugs that enter cancer clinical research. Over the past five years, twice as many trials have resulted in only a 10% increase in approvals. Industry investment in R&D has gone backwards, and with it comes a soaring cost of innovation that drives drug prices. Imagine the public tumult, the demand for our leaders to resign, if only one in 14 of rockets carried our astronauts safely!

Great Strategy is Reconciling what Others Believe are Opposites

The discussion we should be having is how to cure cancer and lower drug prices at the same time. Cancer is a multidimensional, ever-changing disease of the entire cell system. The standard focus on individual targets — while supporting publications to drive academic careers and intellectual property that supports high-risk industry investment — has failed. The secrets of biology lay in the interactions between molecules: the dynamics. We need to hack into a human cell as if it were a computer and decode the operating system: switch these proteins off to cure pancreatic cancer, turn others on to end heart disease, and deliver smart growth factors to regenerate neural tissue.

If predictive engineering was the impetus behind space travel, then systems biology can spur innovation and foster initiatives of “cell exploration.” Systems biology is the method of building models of complex biological environments so we can design the right drug from the start. These drugs would have fewer off-target effects and last longer at the disease site. They would also cost less because the cost of failure of the present “scattershot” system of drug discovery would not be passed along to the consumer.

The NIH is a national treasure that houses the tiny National Centers for Systems Biology, a network of our top academic institutions and thought leaders who are already on the path to uncovering cellular secrets. But last year, of the $25 billion in grants supported by the NIH, those aimed at the truly transformational opportunity of systems biology totaled a mere $8 million, or .032% of the total.

Many of us now know that a “war on cancer,” campaign promises massive infusions of capital, top-down political coordination and even the genomic revolution do not come close to the value created by a greater understanding of systems biology. If we call it a moonshot, but don’t comprehend the real key to putting a man on the moon, how is that different than a crapshoot?

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

March, 2016|Oral Cancer News|

Here’s why the drug that helped Jimmy Carter get ‘cancer-free’ is such a big deal

Source: www.businessinsider.com
Author: Lydia Ramsey

jimmy-carter-3

Former US President Jimmy Carter announced on Sunday that his latest brain scan showed no sign of cancer, a few months after revealing that he had been diagnosed with melanoma that had spread from his liver to his brain.

Carter was being treated with a cancer drug called Keytruda that uses the immune system to fight off cancerous cells.

Keytruda, made by pharmaceutical company Merck, was originally approved by the FDA in September 2014 to treat melanoma, a deadly form of skin cancer that can also show up in other organs of the body, as it did in Carter’s case.

In someone with melanoma, certain proteins called PD-1 stop the immune system from doing its job and fighting the cancerous cells. Keytruda works by getting in the way of those proteins, allowing the immune system to access the cancer cells. Then, with the help of radiation therapy, which works to shrink tumors by killing cancer cells, it can knock the cancer out.

The drug is delivered intravenously every three weeks, costing about $12,500 a month.

And the drug isn’t just being used in cases like Carter’s. Keytruda, which got approved to treat a form of lung cancer in October, is also being explored to treat a number of other cancers, including head and neck, breast, and bladder cancers and Hodgkin lymphoma.

It’s also not the first cancer immunotherapy drug. Scientists have been seriously exploring using the immune system to battle cancerous cells for decades as an alternative to chemotherapy, radiation therapy, and surgery. But it’s taken a long time for the treatments to be effective in humans.

On Monday, Merck also announced that it has initiated two final phase trials using Keytruda in patients with multiple myeloma, a type of blood cancer that affects a type of white blood cell called plasma cells.

In November, the FDA approved three multiple myeloma drugs, including another cancer-immunotherapy drug called Empliciti.

 

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

December, 2015|Oral Cancer News|

A cancer on the rise, and the vaccine too late for Gen X

Source: www.cnn.com
Author: Martha Shade
 
151014135224-generation-x-hpv-graphic-exlarge-169

(CNN)The vaccine given to prevent cervical cancer in women could end up saving men’s lives, too.

Evidence is mounting that the HPV vaccine is also effective in preventing other HPV-related cancers, including those of the head and neck. Although most people who get HPV do not develop cancer, rates of HPV-related head and neck cancers are dramatically rising for men aged 40 to 50, according to Dr. Maura L. Gillison, the Jeg Coughlin Chair of Cancer Research at the Ohio State University Comprehensive Cancer Center.

When Gillison recently gave a presentation showing the increasing rate of HPV-related head and neck cancer among men, her audience was shocked. “I’ve never shown a slide where the audience gasps,” she said.

Related: Yes, oral sex can lead to cancer

“The risk of getting this cancer is strongly related to when you were born. If you are currently a 40- to 45-year-old man, your risk of getting this cancer is dramatically higher than a 40- to 45-year-old man three or four decades ago,” Gillison said.

Today’s 40- to 50-year-old men have had more sexual partners and have engaged in more oral sex than previous generations, according to experts, significantly raising their risk of an HPV-related head and neck cancer.

Actor Michael Douglas made headlines in 2013 when he announced he was battling an HPV-related cancer and that he got it from performing oral sex. Douglas was 68 when he was diagnosed, but many of the men being diagnosed with these HPV-related cancers are much younger.

What’s a Gen X’er to do?

HPV is usually acquired when young. It can lay dormant, and most oropharyngeal cancer (a type of head and neck cancer) is diagnosed decades later, beginning around age 40 to 50. And the more partners you have, the greater your risk.

HPV vaccines weren’t recommended and approved in the United States until 2006. And the vaccine was not even recommended for boys until 2011.

So what’s an aging Gen X’er to do?

“You’re starting to get colonoscopies; you’re starting to get checked for prostate cancer. This is one more thing to add to that list that you really have to watch for,” said Brian Hill, founder of the Oral Cancer Foundation.

Warning signs of HPV-related head and neck cancer

• Persistent lump on neck

• Persistent earache on one side

• Swelling or lump in the mouth

• Chronic sore throat

• Difficult or painful swallowing

• Change in voice

Source: Oral Cancer Foundation, Dr. Carole Fakhry

Symptoms of HPV-related head and neck cancer include a change in voice, a sore throat that doesn’t go away, an earache on one side and difficult or painful swallowing.

Hill’s story is typical: His doctors initially assumed he had an enlarged lymph node due to an infection. Two doctors gave him antibiotics before he was diagnosed with late-stage oropharyngeal cancer. His experience led him to form the Oral Cancer Foundation.

Finding the disease at an early stage is lifesaving. When it’s diagnosed early, these HPV-related cancers are survivable, according to Dr. Carole Fakhry of the Johns Hopkins Head & Neck Cancer Center. “If you have a lump in your neck, make sure to get checked.

“A very common story is: ‘I was shaving and I noticed this lump in my neck,” she said. “And he goes through two or three rounds of antibiotics and then someone finally thinks about cancer.”

‘Dental hygienists are becoming the best screeners’

Traditionally, cancers of the head and neck were often linked to alcohol or smoking, and these non-HPV cancers tend to be located at the front of the mouth and the voice box. Incidence of these cancers are dropping.

“The truth of the matter is that smoking-related cancers are declining,” Fakhry said. “On the other hand, cancers related to HPV are increasing.”

HPV-related cancers usually originate in the back of the mouth. “Most of these cancers are tonsils and back-of-tongue cancers,” she said. “Tonsils are basically these crypts, and tumors grow deep within these crypts, so these tumors can be hard to find.”

Since tumors are often hidden, dentists and dental hygienists are becoming the first line of attack. Men may also be more likely to visit a dentist regularly than a doctor, according to Hill.

“Dental hygienists are becoming the best screeners for this. They’re becoming the point at the end of the spear when it comes to screening and finding abnormalities,” he said.

Dentists and hygienists are encouraged to look for telltale signs of HPV-related cancer: asymmetrical or swollen tonsils, or a lesion in the back of the throat. But these cancers are notoriously tough to spot and tend to be diagnosed after patients develop a lump in the neck.

So what can you do?

“Make sure you get your kids vaccinated (for HPV),” Fakhry said.

Dr. Dan Beachler, lead author of a new study that found further evidence the HPV vaccine protects against multiple types of HPV-related cancers, agrees: “We still don’t know that much about oral HPV. Primary prevention through vaccination might have the most potential.”

Besides the cervix and the head and neck, some strains of HPV can also lead to cancer of the anus, penis and vulva.

A preventive HPV vaccine is most effective when given to children before they become exposed to HPV. The three dose series is recommended at age 11 or 12.

Initially recommended just for girls, the Centers for Disease Control and Prevention now recommends that boys be vaccinated, too. In addition, vaccination is recommended through the age of 26 in women and through age 21 in men who were not vaccinated previously.

“Young people do not avoid oral sex. That being a given, the best thing we can do is increase the vaccination rate. The second thing we can do is be highly aware of signs and symptoms,” Hill said.

And don’t panic. Although HPV-related cancers are on the rise, they’re still uncommon.

“Even though the rates are dramatically increasing, it’s still a relatively rare cancer. We don’t want to create a panic. We just want to raise awareness,” Gillison said.

Researchers Find Hookah Smoking Can Lead to Serious Oral Conditions – Equivalent To Smoking 100 Cigarettes

Source: www.multivu.com
Author: PR Newswire
 
e3ead314-ce94-429b-9664-5c475f1c4d80.HR

CHICAGO, Oct. 28, 2015 /PRNewswire/ — According to the Centers for Disease Control and Prevention, 2.3 million Americans smoke tobacco from pipes, and many of those who smoke waterpipes, or hookahs, believe it’s less harmful than cigarettes. However, research published in The Journal of the American Dental Association (JADA) suggests hookah smoking is associated with serious oral conditions including gum diseases and cancer.

“We found that waterpipe smoking is associated with serious health problems affecting the head and neck region,” said study author Teja Munshi, B.D.S., M.P.H of Rutgers University. “The public needs to know they are putting themselves at risk. They should be made aware of the dangers of smoking hookahs.”

The authors conducted a literature review that focused on waterpipe smoking and head and neck conditions. They found waterpipe smoking to be associated with gum diseases, dry socket, oral cancer and esophageal cancer among other conditions. According to the World Health Organization, smoking a hookah is the equivalent of smoking 100 cigarettes, based on the duration and number of puffs in a smoking session.

“This study sheds light on the common misconception that smoking from a waterpipe is somehow safer than smoking a cigarette,” said JADA Editor Michael Glick, D.M.D. “Whether you are smoking a cigarette, an e-cigarette, a cigar, or tobacco from a waterpipe, smoking is dangerous not only to your oral health but to your overall health.”

The American Cancer Society is hosting The Great American Smokeout on November 19, 2015, an annual event that encourages smokers of all kinds to give up the habit. The event asks smokers to quit even for just one day to take a step toward a healthier life.

Millions of Americans still use traditional methods of smoking, but emerging trends in the smoking industry, such as hookah smoking and e-cigarettes pose dangers as well. E-cigarettes are devices that turn liquid into a vapor containing nicotine. In an editorial in the September 2015 issue of JADA, authors warned readers of the potential dangers of e-cigarettes, indicating that oral health effects of their use has been inadequately investigated.

“Additional research is needed on the impact smoking has on overall health, but it’s clear that smoking of all kinds has the potential to be dangerous,” said Dr. Glick.

Dentists have an important role in advising patients of the dangers of smoking. The American Dental Association has long been a proponent of educating the public about its hazards and has urged for continued research into the adverse health effects of tobacco use. For more information on smoking and its oral health effects, visit MouthHealthy.org.

a6f163f2-97e1-485c-849b-0b19dbcef848.HR

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

October, 2015|Oral Cancer News|

Vaccine clears some precancerous cervical lesions in clinical trial

Source: www.sciencedaily.com
Author: Mark L Bagarazzi, MD et al.
 

Scientists have used a genetically engineered vaccine to successfully eradicate high-grade precancerous cervical lesions in nearly one-half of women who received the vaccine in a clinical trial. The goal, say the scientists, was to find nonsurgical ways to treat precancerous lesions caused by HPV.

“Every standard therapeutic option for women with these lesions destroys part of the cervix, which is particularly relevant for women of childbearing age, who may then be at risk for preterm birth due to a weakened cervix,” says Cornelia Trimble, M.D., professor of gynecology and obstetrics, oncology, and pathology at the Johns Hopkins University School of Medicine, and first author of the new report, which appears online Sept. 17 in The Lancet. “A vaccine able to cure precancerous lesions could eventually be one way women can avoid surgery that is invasive and can also harm their fertility.”

High-grade cervical lesions, termed CIN2/3, occur most often in women 40 or younger, according to Trimble, a member of Johns Hopkins’ Kelly Gynecologic Oncology Service and Kimmel Cancer Center. Because the lesions can progress to cancer, they are usually removed by surgery, freezing or laser. The procedures are successful in removing the precancerous areas in approximately 80 percent of women, says Trimble. Less troublesome lesions, called low-grade dysplasia, are usually monitored by physicians rather than immediately removed because they pose less of a risk for cancer and usually regress on their own.

For the study, the scientists used a vaccine, originally developed by University of Pennsylvania scientist David Weiner, Ph.D., which is engineered to teach immune system cells to recognize precancerous and cancerous cells. Those cells are coated with proteins linked to an infection with two strains of HPV — 16 and 18 — that cause cervical cancer. The vaccine, given by injection into the arm, is made by Inovio Pharmaceuticals Inc., which funded the clinical trial, and whose employees co-authored the report with Trimble.

Between 2011 and 2013, the scientists recruited 167 women, ages 18 to 55, with newly diagnosed, high-grade precancerous cervical lesions. The women were randomly assigned to receive either three doses of the vaccine or saline injections over a 12-week period at 36 hospitals and private gynecology practices in the U.S. and six other countries.

After each of the injections, the scientists gave the women a small electric pulse at the site of the injection. Cells near the electric pulse open their pores, says Trimble, increasing the likelihood that the vaccine will be taken up by immune system cells.

Of 114 women who received at least one vaccine dose, 55 (48.2 percent) had a regression of their precancerous lesion, meaning their lesions disappeared or converted to low-grade lesions, compared with 12 of 40 (30 percent) who received saline injections. Of the 114, 107 received all three vaccine doses, and 53 of them (49.5 percent) had regression of their lesions. Of the 40 in the saline group, 36 got all three injections, and 11 of them (30.6 percent) had regression of their lesions. Thirteen women dropped out of the study after enrollment.

Two patients discontinued the study because of pain at the injection site. Skin redness was more common in the vaccine group compared with saline.

Among women who completed all three injections, scientists could find no trace of HPV in the cervixes of 56 of the 107 women who received the vaccine, compared with only nine of 35 saline recipients.

“In many of these women, the vaccine not only made their lesions disappear, but it also cleared the virus from their cervix,” says Trimble. “In most unvaccinated patients whose lesions went away, the virus was still present, and many still had low-grade lesions.”

Trimble says clearance of the virus is a “significant bonus” from receiving the vaccine because persistent HPV infection is a major risk factor for recurrence of cervical lesions.

After 12 weeks, doctors surgically removed lesions that did not regress and took biopsies of each study participant’s cervix. In the surgically removed lesions, scientists found miniscule cancers in two of the women who received the vaccine. Trimble says these microinvasive cancers are rarely diagnosed by a biopsy but are found in surgical specimens.

n the biopsy samples, the scientists found that patients whose lesions completely regressed after treatment had more immune cells, called T cells, present in the tissue. “It’s important that T cells capable of recognizing HPV stay in the cervix and fight off any recurrence of the infection,” says Trimble.

“This is a great first step,” says Trimble. “We showed that the vaccine may enable an immune response in a person whose immune system was initially not adequately engaged or was hampered in some way so as to let the lesion occur.”

Trimble says that precancerous lesions are unlikely to progress to cancer during the vaccine treatment period, and monitoring of high-grade lesions is done routinely for pregnant women. “It typically takes about 10 or more years for precancerous cells to become cancer, so there is a window of opportunity to intervene with nonsurgical approaches to reverse the process of viral-associated cancers,” says Trimble.

Trimble says she and her colleagues are now working to identify biomarkers from cervical tissue that can predict which lesions are more likely to persist and eventually progress to cancer. The research team will be monitoring this initial group of study participants to see whether they have fewer recurrences than unvaccinated patients. Trimble is also studying other types of vaccines to prevent the progression of high-grade cervical lesions to cancer.

####

Trimble received an unrestricted grant from Inovio Pharmaceuticals Inc., but she has no other financial or consulting arrangements with the company.

In addition to Trimble, scientists who contributed to the research include Lance Edwards from Suffolk Obstetrics and Gynecology in Port Jefferson, New York; R. Lamar Parker from Lyndhurst Gynecologic Associates in Winston-Salem, North Carolina; Lynette Denny from the University of Cape Town’s Groote Schuur Hospital in South Africa; David B. Weiner from the University of Pennsylvania; and Matthew P. Morrow, Kimberly A. Kraynyak, Xuefei Shen, Michael Dallas, Jian Yan, Mary Giffear, Ami Shah Brown, Kathleen Marcozzi-Pierce, Divya Shah, Anna M. Slager, Albert J. Sylvester, Amir Khan, Kate E. Broderick, Robert J. Juba, Timothy A. Herring, Jean Boyer, Jessica Lee, Niranjan Y. Sardesai, David B. Weiner and Mark L Bagarazzi from Inovio Pharmaceuticals Inc.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

September, 2015|Oral Cancer News|

FDA Grant Forwards Listeria-Based Throat Cancer Vaccine

Source: www.targetedonc.com
Author: Sandra Kear
 
Sikora

An experimental immunotherapy for human papillomavirus-, or HPV-, related throat cancers, which is driven by the Listeria bacteria (that wreaks havoc when ingested), may now move forward due to a $1.1 million dollar grant from the FDA to researchers at Baylor College of Medicine.

 
“Immunotherapy, such as axalimogene filolisbac, which targets HPV proteins expressed in cancer cells is a great example of using a cancer’s own unique biology against it.” said principal investigator Andrew Sikora, MD, PhD, leader of the head and neck cancer program in the NCI Comprehensive Designated Dan L. Duncan Cancer Center and an associate professor of otolaryngology at Baylor College, in an interview with Targeted Oncology.

 

“This is hopefully the first step toward development of more targeted treatment approaches that reduce side effects and cancer treatment-related morbidity by uniquely targeting only virus-infected cells.” 
The Listeria-based HPV immunotherapy, axalimogene filolisbac (ADXS11-001), is developed by Advaxis, and functions by stimulating an immune response against HPV proteins, thus killing infected cells.

 
The drug is currently being evaluated in phase I-II study3 alone or in combination with MedImmune’s durvalumab, in patients with cervical or HPV-positive head and neck cancer. The study has three arms: axalimogene filolisbac alone, durvalumab alone, and the two drugs combined. Primary outcomes established for the study are: number of subjects with adverse events (AEs) in each dose level, number of subjects with AEs in the combination dose, and progression-free survival.

 
Patients must have measurable disease by RECIST criteria, as well as histologically diagnosed squamous cell cancer of the head and neck or squamous, nonsquamous, adenosquamous, carcinoma, or adenocarcinoma of the cervix. HPV positivity is not required for cervical cancer. Enrolled patients must be ≥18 years of age with a performance status of 0 or 1. Females must have a negative pregnancy test, and patients must agree to use two methods of birth control 120 days after the last treatment dose. The estimated study completion date is December 2019.

 
“We continue to accrue patients for this trial and collect blood and tumor specimens. Immune studies are best done in batches, so every time we have the specimens from 5 to 6 patients available, we can start another round of studies looking at things like T-cell responses, changes in immune cell profiles, altered serum cytokines, etc.” Sikora said. “At the end of it, each different assay provides a different snapshot of how the immune system works, and we hope to put them together to comprehensively understand what is happening to the immune system in these patients and how to use this information to put together the next round of clinical trials.”

 
Sikora will collaborate with the Icahn School of Medicine at Mount Sinai in New York City and with Advaxis. The grant was given by the FDA’s Orphan Products Grants Program, which supports clinical development of new treatments for rare diseases or conditions where no current treatment exists or superior treatments are needed.

 
“The grant from the FDA is a total game changer, because not only does it make it possible for us to fully complete accrual of the trial, but it gives us the opportunity to perform really cutting-edge analyses on the samples collected. We now have the opportunity to use nearly every tool at our disposal to meticulously profile and understand how this therapy drives antitumor immune responses,” said Sikora.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

September, 2015|Oral Cancer News|

NYU’s Bluestone Center Receives a $369,250 High Priority, Short Term Project Award from NIDCR to Study Oral Cancer Pain

Source: www.nyu.edu/news
Author: Christopher James
 

Drs. Yamano and Schmidt have developed a novel non-viral gene delivery method, and the proposed studies are designed to test whether this could be used to treat cancer pain effectively and safely.

Up to 90% of cancer patients suffer from pain, with oral cancer ranked consistently as one of the most painful cancers. The quality of life for oral cancer patients is the lowest of any patients suffering from cancer because the intense uncontrolled pain interferes with necessary oral functions including eating, talking and swallowing.

“Oral cancer pain is more severe, and the opioid requirement is higher, than pain from any other cancer,” said Dr. Brian L. Schmidt, DDS, MD, PhD, professor in the Department of Oral and Maxillofacial Surgery, and director of NYU’s Bluestone Center for Clinical Research and the NYU Oral Cancer Center. “And in the end, pharmacological agents used to treat cancer pain often lack anatomical specificity and produce off-target effects that create additional suffering.”

“Gene therapy is emerging as an exciting prospect and alternative to opioids for the treatment of cancer pain,” said Dr. Seiichi Yamano, DDS, PhD, DMD, MMSc, assistant professor of prosthodontics at NYU College of Dentistry. “We seek to eliminate oral cancer pain by reversing epigenetic changes using gene therapy and set the stage for a new class of medicines that selectively disrupt nociceptive signaling with limited off-target effects.”

To further their research, the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institute of Health (NIH) has awarded Drs. Schmidt and Yamano a one-year, $369,250 High Priority, Short-Term Project Award (R56) to study the efficacy of a novel non-viral gene delivery method. The proposed studies are designed to test whether nonviral gene delivery into the oral cancer could be used to treat cancer pain effectively and safely.

“Viral vector-based treatment of cancer pain has been evaluated in preclinical studies but problems with immune response, limited DNA carrying capacity, recombination and high cost have been encountered,” said Dr. Schmidt. “Synthetic, non-viral vectors are potential alternatives to viral vectors that preclude these obstacles.”

To improve non-viral gene transfer efficiency, Dr. Yamano recently created two novel nonviral hybrid vectors: a cell-permeable peptide (CPP) combined with either a cationic lipid (CPP/lipid) or a cationic polymer (CPP/polymer). These nonviral vectors have excellent transfection efficiency with little cytotoxicity across a range of cell lines including different types of cancer cells.

The researchers also found that the transfection efficiency using the nonviral vector in oral cancer cells has a significantly higher expression (~8-fold) than normal cells and has a higher expression (~65%) than an adenoviral vector (~50%). In vivo transfection with either of these nonviral vectors leads to high and long-term transgene expression (~7 months) after intramuscular injection of the vectors.

“We recently demonstrated that OPRM1 (the gene for the µ-opioid receptor) is methylated and down regulated in oral cancer compared to matched normal tissues in the same patients; these patients reported pain at the site of cancer,” said Dr. Schmidt. “We further demonstrated that OPRM1 re-expression with viral transduction significantly reduced cancer pain in a mouse model.”

Based on their preliminary work, the researchers hypothesize that re-expression of the OPRM1 gene within oral cancer using our non-viral vectors will attenuate cancer pain and restore orofacial function without excessive toxicity. Their research has three specific aims:

  1. To determine the efficacy of ex vivo OPRM1 gene transfer with non-viral vectors to attenuate cancer-induced pain, with the goal to move their method of non-viral transfection to the clinic, with the goal of clinicians directly inoculating their non-viral vector into an oral cancer;
  2. To determine the feasibility and efficacy of in vivo OPRM1 gene transfer (i.e. directly into the tongue cancer) with non-viral vectors for attenuation of cancer-induced pain; and
  3. To analyze toxicity and immune response in the cancer mice treated with non-viral OPRM1 gene delivery.

“The proposed research is significant because we will use a local delivery technique directly into the cancer to reduce the potential side effects of systemic drugs,” continues Dr. Yamano. “Our approach is innovative because we will transduce the cancer cells for the treatment of cancer pain and our non-viral vector more efficiently targets oral cancer cells relative to normal cells. Ultimately, these studies might facilitate the development of an effective therapy to treat cancer pain.”

The researchers note that, tragically, approximately half of all oral cancer patients will not be cured with surgery, chemotherapy or radiation therapy. Oral cancer is the sixth most common cancer in the US; more patients are afflicted with oral cancer than with melanoma, cervical cancer, or ovarian cancer. The intensity of oral cancer pain escalates with disease progression, and terminal patients generally experience debilitating pain during their final months of life.

NIH NIDCR R56 grant number: R56DE025393 (Schmidt/Yamano)

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

The Cost of Cancer Drugs

Source: www.cbsnew.com
Author: Lesley Stahl
 

The following is a script of “The Cost of Cancer Drugs” which aired on October 5, 2014, and was rebroadcast on June 21, 2015. Lesley Stahl is the correspondent. Richard Bonin, producer.

Cancer is so pervasive that it touches virtually every family in this country. More than one out of three Americans will be diagnosed with some form of it in their lifetime. And as anyone who’s been through it knows, the shock and anxiety of the diagnosis is followed by a second jolt: the high price of cancer drugs.

They are so astronomical that a growing number of patients can’t afford their co-pay, the percentage of their drug bill they have to pay out-of-pocket. As we first reported in October, this has led to a revolt against the drug companies led by some of the most prominent cancer doctors in the country.

Dr. Leonard Saltz: We’re in a situation where a cancer diagnosis is one of the leading causes of personal bankruptcy.

Dr. Leonard Saltz is chief of gastrointestinal oncology at Memorial Sloan Kettering, one of the nation’s premier cancer centers, and he’s a leading expert on colon cancer.

Lesley Stahl: So, are you saying in effect, that we have to start treating the cost of these drugs almost like a side effect from cancer?

Dr. Leonard Saltz: I think that’s a fair way of looking at it. We’re starting to see the term “financial toxicity” being used in the literature. Individual patients are going into bankruptcy trying to deal with these prices.

Lesley Stahl: The general price for a new drug is what?

Dr. Leonard Saltz: They’re priced at well over $100,000 a year.

Lesley Stahl: Wow.

Dr. Leonard Saltz: And remember that many of these drugs, most of them, don’t replace everything else. They get added to it. And if you figure one drug costs $120,000 and the next drug’s not going to cost less, you’re at a quarter-million dollars in drug costs just to get started.

Lesley Stahl: I mean, you’re dealing with people who are desperate.

Dr. Leonard Saltz: I do worry that people’s fear and anxiety are being taken advantage of. And yes, it costs money to develop these drugs, but I do think the price is too high.

The drug companies say it costs over a billion dollars to bring a new drug to market, so the prices reflect the cost of innovation.

The companies do provide financial assistance to some patients, but most people aren’t eligible. So many in the middle class struggle to meet the cost of their co-payments. Sometimes they take half-doses of the drug to save money. Or delay getting their prescriptions refilled.

Dr. Saltz’s battle against the cost of cancer drugs started in 2012 when the FDA approved Zaltrap for treating advanced colon cancer. Saltz compared the clinical trial results of Zaltrap to those of another drug already on the market, Avastin. He says both target the same patient population, work essentially in the same way. And, when given as part of chemotherapy, deliver the identical result: extending median survival by 1.4 months, or 42 days.

Dr. Leonard Saltz: They looked to be about the same. To me, it looked like a Coke and Pepsi sort of thing.

Then Saltz, as head of the hospital’s pharmacy committee, discovered how much it would cost: roughly $11,000 per month, more than twice that of Avastin.

Lesley Stahl: So $5,000 versus $11,000. That’s quite a jump. Did it have fewer side effects? Was it less toxic? Did it have…

Dr. Leonard Saltz: No…

Lesley Stahl: …Something that would have explained this double price?

Dr. Leonard Saltz: If anything, it looked like there might be a little more toxicity in the Zaltrap study.

He contacted Dr. Peter Bach, Sloan Kettering’s in-house expert on cancer drug prices.

Lesley Stahl: So Zaltrap. One day your phone rings and it’s Dr. Saltz. Do you remember what he said?

Dr. Peter Bach: He said, “Peter, I think we’re not going to include a new cancer drug because it costs too much.”

Lesley Stahl: Had you ever heard a line like that before?

Dr. Peter Bach: No. My response was, “I’ll be right down.”

Lesley Stahl: You ran down.

Dr. Peter Bach: I think I took the elevator. But yes, exactly.

Bach determined that since patients would have to take Zaltrap for several months, the price tag for 42 days of extra life would run to nearly $60,000. What they then decided to do was unprecedented: reject a drug just because of its price.

Dr. Peter Bach: We did it for one reason. Because we need to take into account the financial consequences of the decisions that we make for our patients. Patients in Medicare would pay more than $2,000 a month themselves, out-of-pocket, for Zaltrap. And that that was the same as the typical income every month for a patient in Medicare.

Lesley Stahl: The co-pay.

Dr. Peter Bach: Right. 20 percent. Taking money from their children’s inheritance, from the money they’ve saved. We couldn’t in good conscience say, “We’re going to prescribe this more expensive drug.”

And then they trumpeted their decision in the New York Times. Blasting what they called “runaway cancer drug prices,” it was a shot across the bow of the pharmaceutical industry and Congress for passing laws that Bach says allow the drug companies to charge whatever they want for cancer medications.

Dr. Peter Bach: Medicare has to pay exactly what the drug company charges. Whatever that number is.

Lesley Stahl: Wait a minute, this is a law?

Dr. Peter Bach: Yes.

Lesley Stahl: And there’s no negotiating whatsoever with Medicare?

Dr. Peter Bach: No.

Another reason drug prices are so expensive is that according to an independent study, the single biggest source of income for private practice oncologists is the commission they make from cancer drugs. They’re the ones who buy them wholesale from the pharmaceutical companies, and sell them retail to their patients. The mark-up for Medicare patients is guaranteed by law: the average in the case of Zaltrap was six percent.

Dr. Leonard Saltz: What that does is create a very substantial incentive to use a more expensive drug, because if you’re getting six percent of $10, that’s nothing. If you’re getting six percent of $10,000 that starts to add up. So now you have a real conflict of interest.

But it all starts with the drug companies setting the price.

Dr. Peter Bach: We have a pricing system for drugs which is completely dictated by the people who are making the drugs.

Lesley Stahl: How do you think they’re deciding the price?

Dr. Peter Bach: It’s corporate chutzpah.

Lesley Stahl: We’ll just raise the price, period.

Dr. Peter Bach: Just a question of how brave they are and how little they want to end up in the New York Times or on 60 Minutes.

That’s because media exposure, he says, works. Right after their editorial was published, the drug’s manufacturer, Sanofi, cut the price of Zaltrap by more than half.

Dr. Peter Bach: It was a shocking event. Because it was irrefutable evidence that the price was a fiction. All of those arguments that we’ve heard for decades, “We have to charge the price we charge. We have to recoup our money. We’re good for society. Trust us. We’ll set the right price.” One op-ed in the New York Times from one hospital and they said, “Oh, okay, we’ll charge a different price.” It was like we were in a Turkish bazaar.

Lesley Stahl: What do you mean?

Dr. Peter Bach: They said, “This carpet is $500” and you say, “I’ll give you $100.” And the guy says, “Okay.” They set it up to make it highly profitable for doctors to go for Zaltrap instead of Avastin. It was crazy!

But he says it got even crazier when Sanofi explained the way they were changing the price.

Dr. Peter Bach: They lowered it in a way that doctors could get the drug for less. But patients were still paying as if it was high-priced.

Lesley Stahl: Oh, come on.

Dr. Peter Bach: They said to the doctor, “Buy Zaltrap from us for $11,000 and we’ll send you a check for $6,000.” Then you give it to your patient and you get to bill the patient’s insurance company as if it cost $11,000. So it made it extremely profitable for the doctors. They could basically double their money if they use Zaltrap.

“High cancer drug prices are harming patients because either you come up with the money, or you die.”

All this is accepted industry practice. After about six months, once Medicare and private insurers became aware of the doctor’s discount, the price was cut in half for everyone.

John Castellani: The drug companies have to put a price on a medicine that reflects the cost of developing them, which is very expensive and takes a long period of time, and the value that it can provide.

John Castellani is president and CEO of PhRMA, the drug industry’s trade and lobbying group in Washington.

Lesley Stahl: If you are taking a drug that’s no better than another drug already on the market and charging twice as much, and everybody thought the original drug was too much…

John Castellani: We don’t set the prices on what the patient pays. What a patient pays is determined by his or her insurance.

Lesley Stahl: Are you saying that the pharmaceutical company’s not to blame for how much the patient is paying? You’re saying it’s the insurance company?

John Castellani: I’m saying the insurance model makes the medicine seem artificially expensive for the patient.

He’s talking about the high co-pay for cancer drugs. If you’re on Medicare, you pay 20 percent.

Lesley Stahl: Twenty percent of $11,000 a month is a heck of a lot more than 20 percent of $5,000 a month.

John Castellani: But why should it be 20 percent instead of five percent?

Lesley Stahl: Why should it be $11,000 a month?

John Castellani: Because the cost of developing these therapies is so expensive.

Lesley Stahl: Then why did Sanofi cut it in half when they got some bad publicity?

John Castellani: I can’t respond to a specific company.

Sanofi declined our request for an interview, but said in this email that they lowered the price of Zaltrap after listening “to early feedback from the oncology community and … To ensure affordable choices for patients…”

Dr. Hagop Kantarjian: High cancer drug prices are harming patients because either you come up with the money, or you die.

Hagop Kantarjian chairs the department of leukemia at MD Anderson in Houston. Inspired by the doctors at Sloan Kettering, he enlisted 119 of the world’s leading leukemia specialists to co-sign this article about the high price of drugs that don’t just add a few weeks of life, but actually add years, like Gleevec.

It treats CML, one of the most common types of blood cancer that used to be a death sentence, but with Gleevec most patients survive for 10 years or more.

Dr. Hagop Kantarjian: This is probably the best drug we ever developed in cancer.

Lesley Stahl: In all cancers?

Dr. Hagop Kantarjian: So far. And that shows the dilemma, because here you have a drug that makes people live their normal life. But in order to live normally, they are enslaved by the cost of the drug. They have to pay every year.

Lesley Stahl: You have to stay on it. You have to keep taking it.

Dr. Hagop Kantarjian: You have to stay on it indefinitely.

Gleevec is the top selling drug for industry giant Novartis, bringing in more than $4 billion a year in sales. $35 billion since the drug came to market. There are now several other drugs like it. So, you’d think with the competition, the price of Gleevec would have come down.

Dr. Hagop Kantarjian: And yet, the price of the drug tripled from $28,000 a year in 2001 to $92,000 a year in 2012.

Lesley Stahl: Are you saying that the drug companies are raising the prices on their older drugs.

Dr. Hagop Kantarjian: That’s correct.

Lesley Stahl: Not just the new ones. So you have a new drug that might come out at a $100,000, but they are also saying the old drugs have to come up to that price, too?

Dr. Hagop Kantarjian: Exactly. They are making prices unreasonable, unsustainable and, in my opinion, immoral.

When we asked Novartis why they tripled the price of Gleevec, they told us, “Gleevec has been a life-changing medicine … When setting the prices of our medicines we consider … the benefits they bring to patients … The price of existing treatments and the investments needed to continue to innovate…”

[Dr. Hagop Kantarjian: This is quite an expensive medication.]

Dr. Kantarjian says one thing that has to change is the law that prevents Medicare from negotiating for lower prices.

Dr. Hagop Kantarjian: This is unique to the United States. If you look anywhere in the world, there are negotiations. Either by the government or by different regulatory bodies to regulate the price of the drug. And this is why the prices are 50 percent to 80 percent lower anywhere in the world compared to the United States.

Lesley Stahl: Fifty percent to 80 percent?

Dr. Hagop Kantarjian: Fifty percent to 80 percent.

Lesley Stahl: The same drug?

Dr. Hagop Kantarjian: Same drug. American patients end up paying two to three times more for the same drug compared to Canadians or Europeans or Australians and others.

Lesley Stahl: Now, Novartis, which makes Gleevec, says that the price is fair because this is a miracle drug. It really works.

Dr. Hagop Kantarjian: The only drug that works is a drug that a patient can afford.

The challenge, Dr. Saltz at Sloan Kettering says, is knowing where to draw the line between how long a drug extends life and how much it costs.

Lesley Stahl: Where is that line?

Dr. Leonard Saltz: I don’t know where that line is, but we as a society have been unwilling to discuss this topic and, as a result, the only people that are setting the line are the people that are selling the drugs.

Since we first broadcast our story, President Obama asked Congress to change the law and allow Medicare to negotiate prices with drug manufacturers. Few believe, however, that Congress will let that happen anytime soon.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

Professional Rodeo Competitors Join Fight Against Oral Cancer

Source: www.upr.org
Author: Melissa Allison

 

The number of oral cancer deaths related to tobacco use is on the rise nationwide according to the Oral Cancer Foundation. Brian Hill is the founder of the OCF and a survivor of the disease.

Kiser-OCFCody Kiser encourages the youth to not start using tobacco to help secure good health. Oral Cancer Foundation

 

“Up until about (the year) 2000 this was primarily a disease of older men who had smoked a lot or chewed tobacco during their lifetime,” Hill said. “About that point in time we started to see a shift in the cause of the disease.”

Hill said tobacco is still a primary cause of oral cancers and adds that the oral human papillomavirus type 16 (HPV16) is new etiology that has forced the number of cases to accelerate.

According to an October 2014 study by Johns Hopkins researchers the HPV16 causes cancers of the mouth and throat and that any form of tobacco use increases the risk of the virus. The research suggests as few as three cigarettes a day can increase the risk of infection by almost one-third.

Hill created the foundation in 1999 to promote change by educating the public about risk factors that contribute to the disease. Among those risks is the use of spit tobacco.

“The world of rodeo has been the realm of sponsorship by the tobacco industry for decades,” Hill said. “With the nicotine content in a can of dip equaling approximately that of 80 cigarettes, this addiction can be one of the hardest to break. We hope to educate parents and youth about the dangers before they even get started.”

The OCF is turning to professional rodeo competitors to serve as positive role models during a national campaign.

Cody Kiser is a professional bareback bronc rider from Reno, Nevada.  He was in Delta, Utah recently where he competed at the Millard County Fairgrounds. Kiser told parents at the rodeo that nearly 15 percent of high school boys in the United States use smokeless tobacco.

“My dad was a cowboy, so I know what it’s like looking up to cowboys as heroes for my whole life. Health and fitness have always been incredibly important to my family. My dad was a positive role model in my life growing up in that regard, and the idea of using spit tobacco never appealed to me,” Kiser said. “Right now, I’m pursuing rodeo as a passion of mine, and if at the same time I can do some good in the world and set the right example for young kids who might look up to me, then I’m honored and eager to do so.”

Kiser said cowboys have a reputation that is second only to baseball players for being users of tobacco in the world of sports.  He wants to change that reputation throughout the country and in Utah, where rodeo is popular.

“From my point of view, Utah seems to be on the front lines of health and fitness,” he said.  “I’ve been very impressed with Utah as far as a healthy lifestyle, people who don’t smoke and chew so it’s good to see in Utah that they don’t do that as much.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.