Food and Drug Administration

Can your own immune system kill cancer?

Source: www.cnn.com
Author: Jacqueline Howard

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There was another big win in the advancement of immunotherapy treatments for cancer this week.

The Food and Drug Administration approved an immunotherapy drug called Keytruda, which stimulates the body’s immune system, for the first-line treatment of patients with metastatic non-small-cell lung cancer.

In other words, the drug could be the very first treatment a patient receives for the disease, instead of chemotherapy. Keytruda is the only immunotherapy drug approved for first-line treatment for these patients.

So it seems, the future of cancer care may be in our own immune systems, but how exactly does it work, and what are its pros and cons?

“It’s certainly going to become an independent way of treating cancers,” said Dr. Philip Greenberg, head of immunology at the Fred Hutchinson Cancer Research Center in Seattle, during a Q&A session at the International Cancer Immunotherapy Conference in New York in September.

“We always talk about the three pillars of cancer therapy — radiation therapy, chemotherapy and surgery — and it’s become quite clear now that there’s going to be a fourth pillar, which is immunotherapy,” he said. “There are times where it will be used alone, and there will be times that it will be used in conjunction with the other therapies, but there’s very little to question that this is going to be a major part of the way cancers are treated from now on, going forward.”

Here’s a look at the past, present and future of cancer immunotherapy.

It began with Bessie

In the summer of 1890, 17-year-old Elizabeth Dashiell, affectionately called “Bessie,” caught her hand between two seats on a passenger train and later noticed a painful lump in the area that got caught, according to the Cancer Research Institute.

She met with a 28-year-old physician named Dr. William Coley in New York to address the injury. He performed a biopsy, expecting to find pus in the lump, probably from an infection. But what he found was more disturbing: a small gray mass on the bone. It was a malignant tumor from a type of cancer called sarcoma.

Dashiell had her arm amputated to treat the cancer, but the disease quickly spread to the rest of her body. She died in January 1891. A devastated Coley went on to devote his medical career to cancer research.

Coley is sometimes referred to as the “father of cancer immunotherapy,” according to the Memorial Sloan Kettering Cancer Center.

During his career, he noticed that infections in cancer patients were sometimes associated with the disease regressing. The surprising discovery prompted him to speculate that intentionally producing an infection in a patient could help treat cancer.

To test the idea, Coley created a mixture of bacteria and used that cocktail to create infections in cancer patients in 1893. The bacteria would sometimes spur a patient’s immune system to attack not only the infection but also anything else in the body that appeared “foreign,” including a tumor. In one case, when Coley injected streptococcal bacteria into a cancer patient to cause erysipelas, a bacterial infection in the skin, the patient’s tumor vanished — presumably because it was attacked by the immune system.

Coley’s idea was occasionally studied by various researchers in the 1900s but was not widely accepted as a cancer treatment approach until more recently.

“Immunotherapy has essentially undergone a sort of revolution in the last decade in the sense that something that was experimental — and there were still questions about what role it would have in the way cancer is treated — is completely turned around, and now it’s clear it’s effective,” Greenberg said.

German physician Dr. Paul Ehrlich, who won the Nobel Prize in physiology or medicine in 1908, proposed using the immune system to suppress tumor formation in the “immune surveillance” hypothesis — an idea that seems to follow Coley’s.

Yet it wasn’t until the early 2000s that the hypothesis became more widely accepted, according to the Cancer Research Institute. A landmark review published in the journal Nature Immunology in 2002 supported the validity of cancer immunosurveillance.

“Cancer immunotherapy really refers to treatments that use your own immune system to recognize, control and hopefully ultimately cure cancers,” said Jill O’Donnell-Tormey, CEO of the Cancer Research Institute, during the conference in New York last month.

“Many people for many years didn’t think the immune system was really going to have a role in any treatment for cancer,” she said, “but I think the entire medical community (and) oncologists now agree that immunotherapy’s here to stay.”

‘Turning oncology on its head’

One of the most famous cancer patients to have received a form of immunotherapy is former President Jimmy Carter, who had a deadly form of skin cancer called melanoma. Last year, he announced that he was cancer-free after undergoing a combination of surgery, radiation and immunotherapy.

Carter was taking Keytruda. It’s approved to treat melanoma, non-small-cell lung cancer, and head and neck cancer. However, it’s not the only approved immunotherapy option out there.

“The advances and the results we’ve seen with using the immune system to treat cancer in the last five years or so are turning the practice of oncology on its head,” said Dr. Crystal Mackall, a professor at the Stanford University School of Medicine and expert on cancer immunotherapy.

You don’t want to overstate it. As an immunotherapist, I see things from my vantage point, which is biased, but my clinical colleagues use words like ‘revolution,’ ” she said. “When I hear them say that, I think, ‘Wow, this really is a paradigm shifting for how we think about treating cancer.’ ”

Immunotherapy comes in many forms — treatment vaccines, antibody therapies and drugs — and can be received through an injection, a pill or capsule, a topical ointment or cream, or a catheter.

The FDA approved the first treatment vaccine for cancer, called sipuleucel-T or Provenge, in 2010. It stimulates an immune system response to prostate cancer cells and was found in clinical trials to increase the survival of men with a certain type of prostate cancer by about four months.

Another treatment vaccine, called T-VEC or Imlygic, was approved by the FDA in 2015 to treat some patients with metastatic melanoma.

Some antibody therapies have been approved, as well. Antibodies, a blood protein, play a key role in the immune system and can be produced in a lab to help the immune system attack cancer cells.

The FDA has approved several antibody-drug conjugates, including Kadcyla for the treatment of some breast cancers, Adcetris for Hodgkin lymphoma and a type of non-Hodgkin T-cell lymphoma, and Zevalin for a type of non-Hodgkin B-cell lymphoma.

The FDA also has approved some immunotherapy drugs known as immune checkpoint inhibitors. They block some of the harm that cancer cells can cause to weaken the immune system.

Keytruda, which Carter took, is a checkpoint inhibitor drug. Other such drugs include Opdivo to treat Hodgkin lymphoma, advanced melanoma, a form of kidney cancer and advanced lung cancer. Tecentriq is used to treat bladder cancer, and Yervoy is used for late-stage melanoma.

Additionally, there are many immunotherapy treatments in clinical trials, such as CAR T-cell therapy. The cutting-edge therapy involves removing T-cells from a patient’s immune system, engineering those cells in a lab to target specific cancer cells and then infusing the engineered cells back into the patient. The treatment is being tested to treat leukemia and lymphoma.

“The real excitement now in cellular therapy, in T-cell therapies, is it reflects the developments in an area that we call synthetic biology, which is that you can add genes to cells and you can change what they do, how they behave, how they function, what they recognize,” Greenberg said.

The high price of new immunotherapy drugs has also garnered attention in the field, according to the Fred Hutchinson Cancer Research Center. For instance, some estimates suggest that checkpoint inhibitor treatments could cost as much as $1 million per patient.

As approvals continue, many scientists caution that doctors and patients alike should prepare for potential severe side effects and downsides.

Boosting the immune system with such therapies may cause skin reactions, flu-like symptoms, heart palpitations, diarrhea and a risk of infection. New cancer immunotherapy drugs have even been linked to arthritis in some patients.

A clinical trial conducted by Juno Therapeutics to test the effectiveness of an experimental immunotherapy treatment for lymphoblastic leukemia was halted after three patients died. They suffered cerebral edema or brain swelling.

Greenberg is a scientific co-founder of Juno Therapeutics.

However, “one of the best attributes of immunotherapy and the future of medicine is that it’s very precise in the way that it kills tissue and spares normal tissue, so in some way, immunotherapy is less toxic (than other therapies). There are patients who are treated with checkpoint inhibitors who have essentially no side effects,” Mackall said. “That would never happen with chemotherapy. They would always have side effects.

“Still, you know, the fact remains that probably nothing is perfect, and there are likely to be some side effects, but as far as we know now, they are less likely to be as severe or prevalent.”

As immunotherapy continues to develop as an option for cancer treatment, experts plan to be realistic about forthcoming challenges.

The challenges of immunotherapy

Experts say they hope to better understand why some patients may have different responses to immunotherapy treatments than others — and why some treatments may result in remissions instead of relapses, or vice versa.

“There’s this whole problem of, you give people an immunotherapy, it looks like it’s working, and then it stops working. We get recurrences or progression after some period, and the question is, why did that happen? How can you change it?” Greenberg said.

“This is where the science has come to play an important part: Is it because the immune response was working and somehow the tumor turned it off? And if that’s the case, then we have to look at ways in which we can reactivate the immune system,” he said. “Or is it not that, is it just that the immune system did what it’s supposed to do, but now a variant grew out, now a tumor grew out that’s no longer recognized by the immune response you are enforcing? If that’s the case, then we need ways to build subsequent immune responses to tackle that.”

Therefore, researchers have to better understand the behavior of not only the immune system but also cancerous tumors — and it’s no simple task.

“If there’s a perception that it’s easy, that’s a mistake. I think our lab has spent decades trying to figure out how to manipulate the immune response,” Greenberg said.

“Some patients are anticipating things to change overnight and be immediately available as a therapy. It takes quite a while,” he said, “but I’m quite certain immunotherapy is going to be enormously useful. It’s just, right now, we are limited in what can be done.”

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

October, 2016|Oral Cancer News|

Doctors Trying To Remind Americans That The HPV Vaccine Isn’t All About Sex

Source: thinkprogress.org
Author: Tara Culp-Ressler

 

Dr. Ronald A. DePinho is on a mission.

 
DePinho, who’s been a cancer researcher for decades and currently serves as the president of the University of Texas MD Anderson Cancer Center, wants to reframe the national conversation about the HPV vaccine to drive home a fundamental point.

 
“It’s important to appreciate that this is a cancer vaccine. A cancer vaccine!” DePinho said in an interview with ThinkProgress. “It’s a dream come true that we’ve converted knowledge into something that can actually save lives and avoid getting cancer in the first place. It’s really what we have been hoping for, and now we have it.”
Since the introduction of the HPV vaccine in 2006, the rate of human papillomavirus in teenage girls has plummeted. And the research in this field continues to advance. On Thursday, the Food and Drug Administration approved an updated version of the Gardasil vaccine that protects against nine strains of the cancer-causing virus — more than twice as many as the 2006 version, which covered just four strains.

 
According to DePinho, that’s a really significant advance for cancer care. He doesn’t want it to get lost in the ongoing controversy about HPV vaccination, a round of shots that some parents still worry is unsafe or inappropriate for their kids.
There’s a persistent myth, for instance, that giving teen girls the shots will spur them to become more “promiscuous” because they know they’ll be protected from a sexually transmitted infection. Large scientific studies have debunked the notion that there’s any link between the HPV vaccine and sexual activity, but inoculation rates still lag behind in some of the Southern states that are wary to provide teens with preventative tools to protect their sexual health.
In general, HPV vaccination rates in the U.S. are still much too low, hovering around 30 percent. Public health professionals are aiming to increase those rates dramatically, to at least 80 percent — closer to the percentage of people who get vaccinated against the virus in other developed countries.

 
To accomplish that, the health professionals who have dedicated their lives to treating HPV-related cancers want to move the conversation away from sexuality altogether. Instead of framing Gardasil as vaccine that protects against an STD — which might give some Americans the impression that they don’t need to worry about it — they want to present it as a vaccine that protects against cancer.

 
“It doesn’t seem like it makes sense to see it in terms of a vaccine for a sexually transmitted disease necessarily,” Dr. Erich Sturgis, an expert in head and throat cancer who works as the program director for the MD Anderson Oropharynx Program, said in an interview with ThinkProgress. “Most of us will have an HPV infection at some point in our lifetime and we’ll never know it.”
Nearly all sexually active Americans get HPV at some point in their lives, according to the Centers for Disease Control and Prevention. An estimated 80 percent of people are infected at some point, and most never realize it because the infection resolves itself on its own. But certain strains of the virus go on to cause cervical, vulvar, anal, penile, and oropharyngeal cancers.

 
Without the HPV vaccine, men in particular are put at risk of developing neck and throat cancers. Unlike cervical cancers, which can be detected with regular Pap smears, there’s no way to screen men.

 

Sturgis treats mostly middle aged male patients, and he estimated that about 60 percent of the cancers he deals with are caused by HPV. He said it’s important to increase the rates of vaccination among both girls and boys because it will be another 30 to 40 years before today’s kids hit the point when these type of throat cancers may start displaying themselves.
“To let your kids potentially suffer later in life is just a tragedy. That’s really the message here,” he said.

 
Both cancer doctors are optimistic that once more parents are educated about what’s at stake, they’ll start vaccinating their kids at higher rates. There’s a big information gap — one recent study found that 70 percent of U.S. adults didn’t realize the HPV vaccine has any connection to cancer whatsoever — that they believe can be corrected with more investment from primary care doctors who are on the front lines of recommending the shots.

 
“It’s really about empowering parents and health care professionals, and making them recognize that this is a childcare responsibility and a priority for all of us,” DePinho said. “It begins with interviews like this and just having the media getting this information out there.”

 
“Doctors are probably not as good at messaging to the public as we could be. We need some help,” Sturgis agreed.

 

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
December, 2014|Oral Cancer News|

FDA Efforts to Reduce Youth Smoking

Source: USA Today
Published: February 4, 2014
 

 

WASHINGTON — The Food and Drug Administration is launching the government’s largest effort yet to curb tobacco use among at-risk teens.

The $115 million media campaign stems from the FDA’s new authority to regulate tobacco, granted by a 2009 law, says commissioner Margaret Hamburg. The ads will target the roughly 10 million American teens who are open to smoking or are already experimenting with cigarettes, she says.

That investment “is one of the most important efforts in recent times in the effort to reduce youth smoking,” says Matthew Myers, president of the Campaign for Tobacco-Free Kids. “The FDA has carefully researched which ads will have the greatest impact on at-risk youth. These were designed with the same scientific rigor that Madison Avenue uses to market its products.”

Many “at-risk” kids see smoking as a temporary coping mechanism to help them deal with the “chaos” caused by poverty, violence or family turmoil, said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

“We are not talking about happy-go-lucky kids,” Zeller said. “They don’t see themselves as smokers. They think they will be able to quit.”

Although the first round of ads will aim for a broad audience, later campaigns will target specific groups, such as gay teens and Native Americans, Zeller said. Ads from the campaign, called “The Real Cost,” will run on MTV, in Teen Vogue, on YouTube and other social media.

The ads are based on studies that show teens are often more worried about their appearance today than their long-term risk of cancer, Zeller said.

One of the videos features a girl trying to buy cigarettes at a convenience store. When a clerk tells her that she doesn’t have enough money, the girl reluctantly scrapes off part of her cheek, revealing ugly wrinkles beneath, then hands her youthful skin to the clerk.

The campaign comes on the heels of a new surgeon general report, released last month, which calculated that 5.6 million American children will die from tobacco-related illness, unless the country takes immediate action to lower smoking rates. About 3,200 teens try their first cigarette each day and 700 become life-long smokers, Hamburg says

The educational effort stems from the FDA’s expanded authority to regulate tobacco, provided by the Family Smoking Prevention and Tobacco Control Act of 2009.

The FDA cited the 2009 law when it created graphic warning labels for cigarette packs. A federal appeals court struck down those warning labels in 2012.

Although the FDA has asserted its intention to regulate electronic cigarettes, the ads won’t mention them. The agency has not yet issued regulations for e-cigarettes, which contain nicotine but no tobacco.

The media campaign is one of three major anti-smoking efforts this year.

The Centers for Disease Control and Prevention this week relaunched its “Tips from Former Smokers” campaign, which began in 2012. That effort, costing $48 million to $60 million each year, has been credited with helping 100,000 Americans quit smoking.

The “truth” campaign — run by the anti-smoking group Legacy — will also launch a media campaign this summer, said Robin Koval, the group’s president and CEO. The truth campaign — funded by the Master Settlement Agreement between tobacco companies and the states – has been credited with preventing 450,000 young people from smoking from 2000 to 2004.

Yet Myers said these efforts are dwarfed by the tobacco industry, which spends more than $8 billion a year on marketing.

 

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

 

February, 2014|Oral Cancer News|

Cannabis chewing gum targets oral side effects

Source:
Author: staff

The company Medical Marijuana has acquired a 50% stake in CanChew, a cannabinoid (CBD)-based chewing gum developed as a pharmaceutical delivery mechanism to relieve pain, xerostomia, and other side effects of disease and disease treatment.

The acquisition gives Medical Marijuana worldwide exclusive rights to develop, manufacture, market, and distribute both tetrahydrocannabinol (THC) and non-THC hemp-derived cannabinoid-infused chewing gum to medical marijuana consumers, according to the company. The U.S. Food and Drug Administration currently considers non-THC based hemp products to be “food-based” and therefore legal without a medical marijuana license.

Cannabinoids have had positive effects in clinical trials on neuralgic pain, multiple sclerosis, and spinal cord injuries, nausea and vomiting from chemotherapy and radiation treatment, as well as palliative treatment of various cancers and HIV/AIDS, the company stated.

According to Sanammad, the company that developed CanChew, the gum can:

  • Alleviate acute and chronic pain
  • Diminish nausea and vomiting, as well as cachexia, which is a syndrome common in cancer patients on chemotherapy that causes appetite loss and loss of weight and muscle-mass
  • Enhance appetite
  • Improve muscle relaxation, coordination, and mobility
  • Diminish xerostomia
  • Promote fresh breath and maintain oral hygiene

“Functional chewing gum is well-established as an effective way to deliver pharmaceutical active ingredients,” said Michael Llamas, president of Medical Marijuana. “A great example is Nicorette. Within 10 minutes of chewing Nicorette gum, the consumer’s symptoms of nicotine withdrawal begin to ease. Our formulations also have an exceedingly safer side-effect profile compared to the currently available analgesics such as opioids, NSAIDs [nonsteroidal anti-inflammatory drugs], and Paracetamol (Tylenol).”

The 795 Thousand and Ending a Century of Tobacco

Source: Oxford Journals

Tonight, a grandfather will read his grandson a soothing bedtime story. Yesterday, a mother saw her son perform a brilliant violin solo. Tomorrow, a grandfather will see his granddaughter complete the first unassisted triple play in their community’s t-ball league history.

What do these vignettes have in common? They represent just three of the 795 851 people––the 795 thousand––whose premature deaths from lung cancer were averted in the United States through aggressive tobacco control policies and interventions between 1975 and 2000, as determined by a series of consortium-based sophisticated modeling techniques and reported by Moolgavkar et al. (1) in this issue of the Journal.

Sometimes, we become inured to the sheer number of deaths caused by tobacco—for example, a predicted 1 billion tobacco-caused deaths this century, 100 million people killed by tobacco in the 20th century, 6 million deaths per year globally, 443 000 deaths per year in the United States, etc. But, despite these enormous, and even numbing, numbers, we need to remember that every one of these 1 billion, 100 million, 6 million, or 443 000, was a father, mother, brother, sister, son, or daughter who, if tobacco had not intervened, would have enjoyed, and shared, a longer, healthier, and more fulfilling life.

How did this happen? How did we allow tobacco, over the past 100 years, to kill and cause disease with such abandon? And, more important, how have we begun to turn the tide against the tobacco tsunami and how can we continue to learn from our experience? To best address these questions, we need to take a step back and briefly put tobacco in historical context.

In his Booker Prize–winning novel, The Sense of an Ending, Julian Barnes’ central character defines history as “… that certainty produced at the point where the imperfections of memory meet the inadequacies of documentation” (2). Fortunately, regarding tobacco, our often inadequate memories are offset by extensive documentation, provided––ironically enough––by the tobacco industry itself (3) and by superb historians (4,5). They remind us that tobacco has long had a revered place in America—witness the tobacco leaves blended into the columns of the US Capitol, our cinema industry’s affection for cigarettes, and the nearly 100 years that have passed since manufactured cigarettes began to take their deadly toll in this country.

This reverence for tobacco has only begun to change in the last half century with the publication of the UK Report of the Royal College of Physicians in 1962 (6) and the US Surgeon General’s Report on Tobacco and Health in 1964 (7). Both of these landmark reports concluded, for the first time and with solid scientific evidence, that cigarette smoking is a cause of lung cancer and other diseases. Continuing in this historical vein, and focusing specifically on the 1975–2000 period, Moolgavkar et al. (1) provide us with three scenarios, each predicting the number of lung cancer deaths in the US during that time if: 1) we had done nothing about tobacco use—3 908 048 lung cancer deaths; 2) we did what we have done about tobacco use—3 119 753 lung cancer deaths; and 3) tobacco control efforts had been completely effective—1 397 540 lung cancer deaths.

These data were arrived at through a painstaking collaborative process that should serve as a model for future analyses in public health more broadly. They are tantalizing—especially in the “what could have been” scenario—but, more important, they give us a clear view to what should be the future of tobacco control in the United States. We have known for some time what “works” in tobacco control, that is, a science-based comprehensive approach (8). That approach includes broad-stroke issues such as the promotion of smoke-free environments, increased tobacco taxes, wide availability of tobacco dependence treatment, and aggressive public information campaigns. This comprehensive approach works best if, additionally, more specific interventions are included, such as litigation against the tobacco industry, omitting tobacco protectionism from trade agreements, or, as reported by Primack et al. (9) in this issue of the Journal, limiting the exposure of youth to tobacco imagery in films, which the authors show to be an important contributor to adolescent smoking behaviors.

Yet, despite knowing what “works” and having the science to back that up, we have often lacked the political and financial will to do what is necessary to take full advantage of our knowledge and put an end to the scourge of tobacco in our society. Although we have been quite successful in reducing tobacco use—from prevalence rates of more than 40% in the early 1960s to slightly less than 20% today—and in saving lives, for example, the 795 thousand—Moolgavkar et al. (1) nevertheless show us that, had we been more aggressive, an additional 2.5 million lung cancer deaths could have been avoided.

The good news is that we have become more aggressive in our tobacco control efforts and, there, again, Moolgavkar et al. (1) provide data to back up that contention. Of the 795 811 lung cancer deaths averted mostly because of tobacco control actions between 1975 and 2000, 70 218 of those deaths were in the year 2000 alone, suggesting an accelerated protective effect.

Also, since 2000, the pace of US tobacco control has accelerated. For example, the Affordable Care Act has opened up tobacco dependence treatment to millions more of the 70% of smokers who wish to quit. The Family Smoking Prevention and Tobacco Control Act has given the US Food and Drug Administration authority to regulate tobacco products and protect both youth and adults from their use. The United States, with the planned addition of graphic warning labels on cigarette packs later this year, has fully embraced, if not ratified, the provisions of the world’s first global public health treaty, the Framework Convention on Tobacco Control. Genetic research on the causes and maintenance of nicotine dependence has had a number of breakthroughs, which may translate to more effective treatment. Tobacco taxes have been raised substantially at the federal, state, and local level. Smoke-free laws and regulations protect millions more smokers and nonsmokers against deadly secondhand smoke at workplaces, in public spaces, and, increasingly, at home. Last, new medications for, and approaches to, tobacco dependence treatment have been developed.

These developments suggest that we may be entering a new era for tobacco control. This era is not without its dangers and potential pitfalls. The tobacco industry remains an aggressive purveyor of cigarettes and other tobacco products within the United States and globally (10); many state governments have reduced their support for tobacco control (11); smoking prevalence rates have stalled at around 20% for the past several years (12); and there remain disagreements within the tobacco control community regarding harm reduction issues (13). Nevertheless, this era has the potential to reinvigorate and expand tobacco control, and, in so doing, bring us closer to the deaths-averted scenario drawn by Moolgavkar et al.

Incidentally, it was my father who, after decades of smoking, died of lung cancer before he was able to see his granddaughter complete that triple play. He was not one of the 795 thousand, but seeing it would have brought tears to his eyes, and thinking of him, and what he missed due to tobacco, brings tears to mine. The data that Moolgavkar et al. (1) provide should, however, give us greater resolve to wipe our tears away, put science to work, and see to it that the 795 thousand grows to many millions of lives saved in the coming decades. We should use all of the tools at our disposal to rein in the rogue tobacco industry, and assiduously apply all of our political, research, advocacy, public health, and clinical skills to end tobacco’s century of death, disease, and disability.

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

April, 2012|Oral Cancer News|

Strong Oral Carcinogen Identified in Smokeless Tobacco

Source: ScienceDaily.com

Although smokeless tobacco products have long been linked with certain cancers, including oral cavity cancers and esophageal cancers, this is the first study to identify a specific chemical present in smokeless tobacco products that induces oral cancer in animals, according to Silvia Balbo, Ph.D., research associate at the Masonic Cancer Center of the University of Minnesota in Minneapolis, Minn.

“(S)-NNN is the only chemical in smokeless tobacco known to cause oral cancer,” Balbo said. “This finding provides mechanistic underpinning for the epidemiologic observations that smokeless tobacco products cause oral cancer.”

Balbo and colleagues administered two forms of NNN called (S)-NNN and (R)-NNN to four groups of 24 rats. The rats were given either (S)-NNN alone, (R)-NNN alone, a combination of both or tap water. The total dose was approximately equivalent to the amount of (S)-NNN to which a smokeless tobacco user would be exposed from chronic use of these products.

All rats assigned to (S)-NNN alone or the combination began losing weight after one year of exposure and died by 17 months. Rats assigned to (R)-NNN or tap water were terminated at 20 months.

All rats assigned to (S)-NNN had esophageal tumors and demonstrated 100 percent incidence of oral tumors including tumors of the tongue, buccal mucosa, soft palate and pharynx. In contrast, researchers found oral tumors in only five of 24 rats given (R)-NNN and esophageal tumors in three of 24 rats assigned to (R)-NNN. Twelve rats given the combination of (S)-NNN and (R)-NNN had 153 esophageal tumors and 96 oral tumors.

“Measures should be taken to reduce this chemical in smokeless tobacco,” Balbo said. “If it is not possible to stop the use of smokeless tobacco products, we should advocate for a reduction of this chemical in these products.”

Because the Food and Drug Administration regulates tobacco products, Balbo said she hoped these results will inform regulatory decisions. Moving forward, she and her colleagues hope to identify other chemicals that may be carcinogens in smokeless tobacco and to understand what level of these chemicals is present in smokeless tobacco products.

“In addition, we have to understand how this research translates to human beings,” Balbo added. “We have to understand the uptake of NNN from smokeless tobacco products in humans and develop better biomarkers, such as urinary biomarkers, to have a tool to monitor the levels to which smokeless tobacco users are exposed.”

Balbo believes these findings are yet another affirmation that tobacco products should be avoided.

This research was funded by a grant from the National Institutes of Health.

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

 

April, 2012|Oral Cancer News|

Tobacco Makers Must List Ingredients, Prove Safety Claims

Source: Businessweek.com

Tobacco companies will have to begin reporting the amount of unsafe chemicals in their products and prove their so-called lower-risk alternatives to smoking such as snuff are actually safer, U.S. regulators said.

The Food and Drug Administration moved today to implement pieces of a 2009 law giving the agency the authority to regulate tobacco products. The FDA released preliminary guidelines for the industry that it says can educate consumers on exactly what is in cigarettes, such as ammonia and formaldehyde, and police claims that certain tobacco products may be safer than others.

The agency will share information on chemical amounts with the public within a year, Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a telephone call with reporters. On the issue of less-risky tobacco items, the draft guidelines set up two categories: one with a higher evidence standard that lets companies claim less harm than cigarettes; and another with a lower standard that permits companies to market products as reducing exposure to unsafe ingredients.

“We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” FDA Commissioner Margaret Hamburg said in a statement. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.”

93 Chemicals

The FDA released a list of 93 chemicals that tobacco makers would have to report the quantity of in their products. The FDA is studying how best to disseminate the information publicly.

“Most people do understand tobacco use is harmful,” Deyton said. “There are also studies that people don’t really understand why to the extent the various chemicals in tobacco are harmful.”

The agency said in the draft on reduced-risk products — which include electronic cigarettes, tobacco lozenges, snuff and snus — that it’s asking for scientific information, including research findings related to a manufacturer’s claim, and may request data comparing the product with cigarettes.

Products in the two categories will be asked to show reduced risk and a benefit to the health of tobacco and non- tobacco users before companies can market them as safer, according to the draft guidelines. The companies also could advertise the products as offering less exposure to harmful ingredients if they prove that future studies may reveal a reduction in disease and death when compared with cigarettes.

Snuff Warnings

Reynolds American Inc. (RAI) (RAI) and its American Snuff unit asked the FDA in July to change labels on smokeless products to: “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” Current labels say the product isn’t a safe alternative to cigarettes.

Altria Group Inc. (MO) (MO), which owns Philip Morris USA and brands including Copenhagen and Skoal, wrote the agency “there is overwhelming scientific, medical and public health consensus that moist smokeless tobacco products” such as snuff or snus, “are substantially less hazardous than cigarettes.”

Snuff and snus are moist powder tobacco that goes under the lip either loose or in a packet.

Shares of Richmond, Virginia-based Altria gained less than 1 percent to $30.87 at the close in New York, while Winston- Salem, North Carolina-based Reynolds increased 1.2 percent to $41.46. Star Scientific Inc. (CIGX) (CIGX) fell 2.4 percent to $3.28.

Scientific Evidence

Star Scientific filed an application with FDA in February 2011 to market its snuff product Stonewall Moist-BDL. Star, based in Glenn Allen, Virginia, said in a statement then that it was the first FDA application for approval of a tobacco product.

Smokeless tobacco can cause mouth cancer, oral health diseases and nicotine addiction, according to the Atlanta-based Centers for Disease Control and Prevention. About 3.5 percent of U.S. adults used smokeless tobacco in 2009. Skoal held 25 percent of the market share the same year, followed by Copenhagen with 24 percent, according to the CDC.

Independent third parties should be required to assess the health effects of modified-risk tobacco products before companies submit applications for review to the FDA, the Institute of Medicine in Washington, which advises the nation on health matters, recommended in a December report.

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

April, 2012|Oral Cancer News|

HPV vaccine myths put health, lives at risk, say health leaders: Airing the facts

Source: TheNationsHealth.org

Vaccination rates for human papillomavirus are lagging for teens, and a complicated web of confusion and misinformation may be to blame, according to public health leaders.

Several strains of HPV can cause cervical cancer, and two vaccines, Gardasil and Cervarix, have been shown conclusively to defend against those strains. The Food and Drug Administration recommended in 2006 that girls receive the vaccine before they become sexually active so that they are protected at the outset. In 2009, FDA approved the use of the vaccine for boys as well.

According to the Centers for Disease Control and Prevention, about 6 million people in the U.S. become infected with HPV each year and each year about 12,000 women are diagnosed with cervical cancer, leading to about 4,000 deaths.

Studies have shown the vaccine to be overwhelmingly safe, CDC said. As of June 2011, about 35 million doses of Gardasil had been distributed in the United States. CDC’s adverse event tracking mechanisms reported about 18,000 adverse events, 92 percent of which were nonserious events, such as fainting, swelling at the injection site and headache. Sixty-eight deaths were reported, but there is “no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine, and some reports indicated a cause of death unrelated to vaccination,” CDC said.

And yet, fed perhaps by misinformation or squeamishness about the idea of their children becoming sexually active, some parents are opting not to vaccinate, and the vaccination rates are lagging, according to CDC.

Figure

Lauren Fant receives an HPV vaccination from nurse Stephanie Pearson at a doctor’s office in Marietta, Ga., in 2007.

Photo by John Amis, courtesy AP Images

“I think that this whole issue is tangled up because this is a sexually transmitted infection that you’re preventing,” said Alina Salganicoff, PhD, vice president for women’s health policy at the Kaiser Family Foundation. “But we also know enough about HPV to know that the majority of women, once they become sexually active, are exposed.”

According to an Aug. 26 study in Morbidity and Mortality Weekly Report, fewer than half of girls ages 13–17 get one dose of the three-dose vaccine, and only 32 percent get all three doses. In comparison, the meningitis and pertussis vaccines, which are also administered to adolescents, have uptake levels of nearly 63 percent and 69 percent, respectively. Coverage varies by state, with just 17.6 percent of girls in Idaho receiving three doses of the vaccine, compared to 55 percent of girls in Rhode Island. Among boys, for whom the vaccine is approved but not explicitly recommended by CDC, the coverage rate nationwide was 1.4 percent for those ages 13–17.

Salganicoff also said misinformation may be leading some parents to be overcautious and delay giving the vaccine to their children.

Political leaders are partly responsible for some of that misinformation, including Rep. Michele Bachmann, R-Minn., who publicly related a story in September that implied that the vaccine could cause intellectual disabilities. Health officials, including the American Academy of Pediatrics, quickly responded, noting there is no evidence that the vaccine causes serious health issues.

“Facts are very important,” wrote the American Congress of Obstetricians and Gynecologists in an open letter to the 2012 presidential candidates. “Especially when discussing the health of the American public.”

Another possible reason for lagging vaccinations is that preteens usually do not have the regularly scheduled wellness doctor visits that babies have, according to Vanessa Cullins, MD, vice president for medical affairs at Planned Parenthood Federation of America. Getting them to medical offices to complete the HPV vaccination schedule can be difficult, she said.

“Anything that requires more than one dose that is not part of a children’s schedule of vaccines tends to be more difficult for people to stay on schedule for,” she said.

But recent studies may provide a way forward.

Gardasil and Cervarix are given in three doses over six months. But a study published Sept. 9 in the Journal of the National Cancer Institute, which looked at two doses of Cervarix, found that two doses might be sufficient.

Mandates requiring vaccination are one way to increase the number of people getting the HPV vaccine, experts noted.

“The experience with immunizations is that when there’s a requirement that a child be vaccinated before he or she can attend school, that is a huge incentive for parents to get kids immunized,” Salganicoff said.

When the HPV vaccine was approved by the Food and Drug Administration in 2006, there was an effort from some in both the public health community and pharmaceutical industry to encourage mandates.

“There was pushback on many levels as a result,” said Salganicoff, an APHA member.

Today, only Virginia and the District of Columbia mandate the vaccine as a condition for students to attend school, and both permit parents to opt out of vaccination, according to the National Conference of State Legislatures.

The comparatively high vaccination rate in Rhode Island is likely due to a combination of factors, said Patricia Raymond, MPH, RN, chief of the Office of Immunization in the Rhode Island Department of Health.

First, Rhode Island is a universal vaccine state, meaning the vaccine is available to providers for all children, regardless of whether they are insured. The state added the vaccine to its list of those covered in November 2006 for girls and July 2010 for boys. The state also covered adolescents who were beyond the recommended age for the vaccine by allowing them to catch up.

The state also has a program called Vaccinate Before You Graduate, a school-based immunization program that up until last year focused on seniors in high school.

“The idea was to catch up kids on vaccines they might have missed,” Raymond told The Nation’s Health, explaining that many colleges or jobs might require vaccines that can cost up to $1,000, so the idea was to vaccinate teens before they entered college or the workforce.

Last year, that program expanded to offer the vaccines to adolescents in grades nine through 12.

“We definitely recommend a school-based program,” Raymond said. “Even though we focused on seniors, there’s still information going home to parents, so that’s another way of getting information to them.”

Both Salganicoff and Cullins see hope for increasing uptake of the vaccine in the coming years. Vaccination rates are slowing climbing, and the Affordable Care Act makes the vaccine available without co-pay, which will make it more accessible.

Cullins told The Nation’s Health there is more that public health professionals can do to improve the HPV vaccination rate. She said in some cases, health care providers are not equipped to give the vaccine and so patients of those providers either go elsewhere or go without. She said while most pediatricians are vaccinators, not all obstetricians and gynecologists are.

“We at Planned Parenthood feel it’s part of primary care that we should all have the vaccine available,” she said.

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

December, 2011|Oral Cancer News|

Europe Bans X-Ray Body Scanners

Source: AVWeb.com

The European Commission decided in November to ban airport body scanning X-ray backscatter machines after studies found a small number of cancer cases linked to use of the devices. The decision affects all airports in Europe, with an exception for U.K. airports that will be allowed to test them, but not deploy them permanently. According to the European Commission, “only security scanners which do not use X-ray technology are added to the list of authorized methods for passenger screening at EU airports.” The commission does approve of full non-X-ray body scanners (radio wave scanners are among those used in the U.S.) when operated under specific guidelines and restrictions. In the U.S., the TSA uses more than 250 backscatter machines at the nation’s 100 busiest airports and is unmoved by Europe’s position. The degree of cancer risk varies somewhat depending on the source … as does the degree of usefulness of the machines themselves.

According to the U.S. Food and Drug Administration, backscatter machines bring a cancer risk of one in 400 million. Research reported by PBS Newshour/ProPublica states that the risk of developing cancer from the machines is “anywhere from six to 100” passengers per year. In a detailed paper submitted to the White House, University of California researchers said that because backscatter X-ray energy is absorbed mainly by the skin and underlying tissue, the skin dosage may be dangerously high in localized areas. The TSA says the amount of radiation emitted by a backscatter machine is similar to three minutes at altitude in a jetliner. For that risk, the TSA says use of the machines has since 2010 identified more than 300 illegal items and potentially dangerous items on the bodies of passengers at airports in the U.S. In January of 2011, a security expert said that in studies, participants asked to sneak explosives past backscatter machines “did it with such ease” that “there is no case for scanners.” The director of the Center for Radiological Research at Columbia University Medical Center told TIME magazine that backscatter machines are “equally effective” and “cost about the same” as machines that use less destructive millimeter waves. The TSA uses both. As for the legality of their use, in the U.S. a Court of Appeals was not moved by statutory or constitutional arguments challenging use of the scanners, but agreed that “the TSA has not justified its failure to issue notice and solicit comments.”

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

December, 2011|Oral Cancer News|

FDA Approves Cetuximab for Late-Stage Head and Neck Cancer

Source: The Oncology Report

The Food and Drug Administration on Nov. 7 approved cetuximab as an initial treatment of late-stage head and neck cancer in combination with chemotherapy.

Cetuximab, marketed as Erbitux by Bristol-Myers Squibb, is an epidermal growth factor receptor (EGFR) antagonist, administered as an intravenous infusion. Previously, it was approved in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma. It was also approved for use alone in patients with recurrent locoregional disease or metastatic disease whose disease has progressed following platinum-based chemotherapy.

The newly approved indication is for the treatment of these recurrent or metastatic patients as an initial therapy in combination with platinum-based therapy with 5-fluorouracil (5-FU), a BMS spokesperson said. (At press time, the company had not yet issued a statement on the approval.)

Erbitux was initially approved in 2004 to treat EGFR-positive late-stage colon cancer after patients stopped responding to chemotherapy and was approved in 2006 for the treatment of head and neck cancer. The newly approved indication is for “recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU,” according to the revised label, posted on the FDA Web site.

The two previously approved indications for head and neck cancer were for “locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy,” and for “recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.

“Erbitux’s ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multitreatment approach for patients,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in the statement. “Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible,” he added.

The approval was based on a multicenter study of 442 patients who had metastatic or recurrent head and neck cancer, which was inoperable or widespread, and of those who had not been treated with chemotherapy. The study was conducted outside of the United States and used a version of cetuximab that is not approved in the United States, the statement said.

The median overall survival among patients who were treated with cetuximab and chemotherapy (cisplatin or carboplatin and 5-fluorouracil) combination was 10.1 months, compared with 7.4 months among those who received chemotherapy alone cisplatin or carboplatin and 5-fluorouracil, the FDA statement said.

The most common adverse events reported by patients in the cetuximab plus chemotherapy arm were rash; pruritus; nail changes; headache; diarrhea; and respiratory, skin, and mouth infections, according to the FDA.

Other adverse effects that have been associated with cetuximab include low serum levels of magnesium, potassium, and calcium; and potentially fatal infusion reactions and myocardial infarctions. Sun exposure should be limited during treatment.

Cetuximab available in the United States provides about 22% greater exposure than the European Union–approved cetuximab that was used in this study, but this pharmacokinetic data along with the results of this study “and other clinical trial data establish the efficacy of Erbitux at the recommended dose,” according to the revised prescribing information posted on the FDA Web site.

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

November, 2011|Oral Cancer News|