cancer

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 online games for real money 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.

A Disorder That’s Hard to Swallow

www.usnews.com
Source: www.usnews.com
Author: Anna Medaris Miller

 

Ed Steger’s​ last meal was a bowl of soup in Las Vegas. “I remember it all too clearly, as if it were yesterday,” he says. But it wasn’t yesterday – it was 2006. “Life is very different” now, says Steger, a 63-year-old former program manager in Houston.

Steger was diagnosed with head and neck cancer​ in 2005. In addition to 36 rounds of radiation and eight regimens of chemotherapy, he underwent six surgeries, including one that replaced a portion of his pharynx and removed parts of his left jawbone, tongue, epiglottis and soft palate.

“The part that makes it odd is that I’m alive after having four recurrences,” Steger says. The part that makes it distressing is that he can’t eat solid foods.

“There are many case studies I’ve seen where patients have said [their] swallowing disorder is the worst part of their disease – and I believe this to be true,” says Steger, who’s president of the National Foundation of Swallowing Disorders. His daily diet consists of four 8-ounce cans of the nutritional drink Boost Plus, along with two to four bottled​ Starbucks Frappuccinos, which he buys at his local supermarket. “It’s a very boring diet that allows me to maintain my weight,” says Steger, who’s 5 feet 10 inches tall and 155 pounds.

It’s unknown how many people have dysphagia, or difficulty swallowing, but the condition can be caused by any one of 30 diverse health events, Steger says. While his dysphagia is a result of surgery, other people have difficulty swallowing due to neurological conditions such as Parkinson’s disease or stroke, digestive disorders including acid reflux or head injuries. Children with developmental disabilities like autism also often have dysphagia.

“[Dysphagia] isn’t a disease, it’s a sign or an outcome of a disease,” says James Coyle​, an associate professor in the University of Pittsburgh’s School of Health and Rehabilitation Sciences who specializes in treating adults with swallowing disorders.

Difficulty swallowing can also be a part of normal aging, suggests research led by Teresa Lever​, an assistant professor of otolaryngology at the University of Missouri School of Medicine. But that doesn’t mean it’s without consequence. For example, people with dysphagia are at risk for choking, dehydration, malnutrition and pneumonia, which can be triggered when food or drink enter the lungs.

“If you can’t walk, you don’t die. If your skin looks horrible, you don’t die. But if you can’t eat and drink, you die,” Lever says. “[Swallowing] is a vital biological function that is a hugely overlooked contribution to morbidity and mortality.”

Aiming to Eat and Drink Again

How clinicians treat dysphagia depends on its cause. If, for example, the condition is brought on by a stroke that paralyzes one side of the throat, a swallowing specialist like a speech-language pathologist first ​might use an imaging test to identify what exactly is going wrong, and then coach the patient on ways to tilt his or her head while eating in order to better prevent food from getting into the airway.​ Such “compensatory strategies,” Coyle says, are “more or less exploiting either gravity or using the change in position to redirect the swallowed material more efficiently and with better airway protection.”

Steger, for one, was trained to swallow by holding his breath, reclining and “letting the liquid flow” down the back of his esophagus and avoiding the airway. “When I swallow, I need to concentrate very hard,” he says.

Mouth and throat exercises can also help patients boost their swallowing abilities. One mouthpiece-like device called SwallowSTRONG, for instance, senses how hard the patient pushes the tongue against the roof of the mouth and progressively guides him or her in resistance exercises.​ “It’s like weightlifting,” Coyle says. “You start off doing low levels of exercise, and we increase the targets every two weeks until the tongue is stronger.”

Other exercises use a similar technique but to improve respiratory function rather than tongue strength. When patients blow against progressively increasing resistance, for example, they’ll develop a better cough reflex. That, in turn, will make it more likely that any food particles or liquids inhaled into the airways will be expelled and not enter the lungs to cause harm, Coyle says. “Dysphagia doesn’t always go away,” he says. “Sometimes we have to teach the person to swallow differently, sometimes we have to beef up other parts of the body to compensate for the fact that the swallowing isn’t going to get better.”

If dysphagia is caused by dementia or another condition that compromises someone’s ability to learn, clinicians must defer to environmental or dietary modifications like prescribing a diet of thickened liquids. The route is a last resort, Coyle says, since “gobs of studies” show that people don’t like thickened liquids, don’t drink them and therefore, are at risk for dehydration.

“All of our cases aren’t successful,” he says, “but when we do have a successful case, it’s so rewarding – the ability to restore a person’s ability to eat and drink.”

Food is Secondary

If Steger woke up tomorrow without dysphagia, he’d eat a T-bone steak grilled with Lawry’s spice, a baked potato with all the fixings and crème brulee for dessert.​ But what he’d look forward to most is going to a restaurant with friends, ordering anything he wants and keeping pace with his companions. “The food is secondary at this point,” he says.

Living with dysphagia isn’t just a medical risk, but can also hamper one’s quality of life and mental health. People with the condition can feel isolated not only because they avoid social eating situations, but also because many of them have medical conditions that affect their voices and compromise their communication. In the support groups for people with Parkinson’s that Steger sometimes attends, the participants, many of whom have dysphagia, “are embarrassed to go out, they’re ashamed, it’s sad,” he says.

One of his goals is to boost funding for dysphagia research, which is slow-going since major funding organizations like the National Institutes of Health are more focused on the diseases that underlie the condition, Steger says. “[Swallowing] is never top of mind when you have head and neck cancer or Parkinson’s until it happens to you,” he says .​But a focus on swallowing itself is not trivial since, for example, hospital patients with dysphagia stay in the hospital 40 percent longer than patients without it, Coyle says. “It’s very important to identify early.”

It’s also important to dedicate resources to the disorder since it will affect more and more people as the population ages, Lever says. She’s now working to identify traits that protect mice – and hopefully, people – from developing dysphagia as they grow old. “Now that we can diagnose dysphagia, we can identify which mouse models have it, and then we can use those mouse models to try to understand what is going wrong to cause dysphagia,” she says. That, in turn, “can then give [us] some targets for treatment.”

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

Merck immunotherapy appears effective in head and neck cancer – study | Reuters

Source: www.firstpress.com
Author: Bill Berkrot

 

A Merck & Co drug that helps the immune system fight cancer was about twice as effective as the current standard therapy for patients with recurrent or advanced head and neck cancers, according to study data released on Friday.

A quarter of the 132 patients who received the drug, Keytruda (pembrolizumab), saw their tumors shrink by at least 30 percent. Fifty-six percent of patients experienced at least some tumor shrinkage in the ongoing single drug Phase I study dubbed Keynote-012, researchers reported.

“This is remarkable because we don’t usually see this level of activity with new agents. We have a track record of failure,” said Dr. Tanguy Seiwert, lead investigator of the study from the University of Chicago.

Advanced head and neck cancer is currently treated with Eli Lilly’s Erbitux, known chemically as cetuximab, which typically has a response rate of 10 percent to 13 percent.

“The only thing that works is cetuximab and this looks at least twice as good,” said Seiwert, who was presenting the Keytruda data at the American Society of Clinical Oncology meeting in Chicago.

ADVERTISING

Merck shares rose more than 1 percent to $60.43 on the New York Stock Exchange.

Keytruda and Opdivo from Bristol-Myers Squibb Co are at the forefront of a promising new class of drugs called PD-1 inhibitors that block a mechanism tumors use to evade the immune system. Keytruda is approved to treat advanced melanoma and awaits a decision for use in lung cancer. It is being tested against 30 types of cancer alone and in various combinations.

While overall survival data was not yet available, Keytruda and Opdivo have extended survival for some patients in other cancers.

“Response rate doesn’t do this justice,” Seiwert said. “A fraction of those patients will probably have long term survival. It can really make a difference for some patients who have incurable metastatic disease.”

The drug appeared to work as well for patients whose cancer tested positive for human papillomavirus as those who were HPV negative. Some older treatments may be less effective in HPV positive patients, researchers said.

Keytruda was well tolerated with few side effects, Seiwert said. Serious immune-related side effects, such as inflammation of the lungs or colon, were reported in a very small number of patients in the study.

Head and neck cancer is the sixth most common cancer worldwide. Patients with recurrent or metastatic head and neck cancer are usually expected to live about 10 to 12 months.

Reporting by Bill Berkrot in New York; Editing by Diane Craft.

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

A Study Finds Smoking’s Toll On Your Body and Health Worse Than Previously Thought

Source: nytimes.com
Author: Denise Grady
 

However bad you thought smoking was, it’s even worse.

A new study adds at least five diseases and 60,000 deaths a year to the toll taken by tobacco in the United States. Before the study, smoking was already blamed for nearly half a million deaths a year in this country from 21 diseases, including 12 types of cancer.

The new findings are based on health data from nearly a million people who were followed for 10 years. In addition to the well-known hazards of lung cancer, artery disease, heart attacks, chronic lung disease and stroke, the researchers found that smoking was linked to significantly increased risks of infection, kidney disease, intestinal disease caused by inadequate blood flow, and heart and lung ailments not previously attributed to tobacco.

Even though people are already barraged with messages about the dangers of smoking, researchers say it is important to let the public know that there is yet more bad news.

“The smoking epidemic is still ongoing, and there is a need to evaluate how smoking is hurting us as a society, to support clinicians and policy making in public health,” said Brian D. Carter, an epidemiologist at the American Cancer Society and the first author of an article about the study, which appears in The New England Journal of Medicine. “It’s not a done story.”

In an editorial accompanying the article, Dr. Graham A. Colditz, from Washington University School of Medicine in St. Louis, said the new findings showed that officials in the United States had substantially underestimated the effect smoking has on public health. He said smokers, particularly those who depend on Medicaid, had not been receiving enough help to quit.

About 42 million Americans smoke — 15 percent of women and 21 percent of men — according to the Centers for Disease Control and Prevention. Research has shown that their death rates are two to three times higher than those of people who have never smoked, and that on average, they die more than a decade before nonsmokers. Smokers are more than 20 times as likely as nonsmokers to die of lung cancer. Poor people and those with less formal education are the most likely to smoke.

Mr. Carter said he had been inspired to dig deeper into the causes of death in smokers after taking an initial look at data from five large health surveys being conducted by other researchers. The participants were 421,378 men and 532,651 women 55 and older, including nearly 89,000 current smokers.

As expected, death rates were higher among the smokers. But diseases known to be caused by tobacco accounted for only 83 percent of the excess deaths in people who smoked.

“I thought, ‘Wow, that’s really low,’ ” Mr. Carter said. “We have this huge cohort. Let’s get into the weeds, cast a wide net and see what is killing smokers that we don’t already know.”

The research was paid for by the American Cancer Society, and Mr. Carter worked with scientists from four universities and the National Cancer Institute.

The study was observational, meaning that it looked at people’s habits, like smoking, and noted statistical correlations between their behavior and their health. Correlation does not prove a cause-and-effect relationship, so this kind of research is not considered as strong as experiments in which participants are assigned at random to treatments or placebos and then compared. But people cannot ethically be instructed to smoke for a study, so a lot of the data on smoking’s effects on people comes from observational studies.

Analyzing deaths among the participants from 2000 to 2011, the researchers found that, compared with people who had never smoked, smokers were about twice as likely to die from infections, kidney disease, respiratory ailments not previously linked to tobacco, and hypertensive heart disease, in which high blood pressure leads to heart failure. Smokers were also six times more likely to die from a rare illness caused by insufficient blood flow to the intestines.

Mr. Carter said he had confidence in the findings because, biologically, it made sense that those conditions were related to tobacco. Smoking can weaken the immune system, increasing the risk of infection, he said. It is also known to cause diabetes, high blood pressure and artery disease, all of which can lead to kidney problems. Artery disease can also choke off the blood supply to the intestines. Lung damage from smoke, combined with increased vulnerability to infection, can lead to multiple respiratory illnesses.

Two other observations supported the findings, he said. One was that the more heavily a person smoked, the greater the added risks. The second was that among former smokers, the risks diminished over time. In general, such effects, known as a dose response, suggest that an observed correlation is more than a coincidence.

The study also found small increases in the risks of breast and prostate cancer among smokers. Mr. Carter said those findings were not as strong as the others, adding that additional research could help determine whether there were biological mechanisms that would support a connection.

A 2014 report by the surgeon general’s office said the evidence for a causal connection between smoking and breast cancer was “suggestive but not sufficient.” The same report found no evidence that smoking caused prostate cancer, but it noted that in men who did have prostate cancer, smoking seemed to worsen the outcome.

The diseases that had previously been established by the surgeon general as caused by smoking were cancers of the esophagus, stomach, colon, liver, pancreas, larynx, lung, bladder, kidney, cervix, lip and oral cavity; acute myeloid leukemia; diabetes; heart disease; stroke; atherosclerosis; aortic aneurysm; other artery diseases; chronic lung disease; pneumonia; influenza; and tuberculosis.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
February, 2015|Oral Cancer News|