Why the FDA Wants More Control over Some Lab Tests

The FDA finds that many so-called laboratory-derived tests may actually harm patients

By Charles Schmidt | Scientific American December 2016 Issue

Every year in the U.S., doctor’s offices and hospitals order billions of laboratory tests to measure everything from cholesterol levels in the blood to the presence of a gene thought to increase the risk of developing Alzheimer’s disease. Physicians and patients typically assume that they can trust the results of these tests. And most of the time they can. But not all lab tests are equally reliable, and faulty ones can have serious consequences. Sometimes they fail to detect life-threatening conditions. Other times they indicate a problem that does not exist, which can lead to unneeded, perhaps even dangerous treatments.

Through a quirk of regulatory history, many such tests are not subject to the same medical standards as other tools used to identify risk for disease or to definitively diagnose a condition. These are called lab-developed tests, or LDTs, defined as tests that are manufactured and interpreted by the same individual lab that designed them—in contrast to, say, a quick strep test meant to be used and understood by a wide variety of personnel in doctor’s offices everywhere. Most people first encounter an LDT during a checkup when the physician is faced with a diagnostic dilemma that cannot be resolved by widely available blood tests.

The trouble is, experts believe many of these tests are not useful, and some may even cause harm by convincing too many people that they have a rare illness when they do not, diagnosing them with a condition that has so far not been shown to be harmful or reassuring them that they are healthy when in fact there is no scientifically credible way to know if that is indeed the case. “We tend to think of lab tests as being the ultimate truth,” says Ramy Arnaout, an assistant professor of pathology at Harvard Medical School. “But no test is 100 percent accurate, and some of these LDTs aren’t medically useful at all.”

The U.S. Food and Drug Administration is now taking steps to restore confidence in the reliability of lab-developed tests. In 2014 the agency released proposed guidelines that will subject the measures, for the first time, to federal oversight—including having to submit evidence of efficacy to it before the tests may be marketed. Although the FDA would not comment for this story, several industry sources believe the final rulings may begin taking effect soon, much to the chagrin of some lab directors who say that the requirements could boost costs and hinder medical practice.

Widening Loophole

Twenty-five years ago LDTs played too small a role in medical practice for the FDA to pay them much attention. Only a few—most notably Pap smears for the detection of cervical cancer—were widely used. FDA officials adopted a policy of “enforcement discretion,” which meant they pretty much left LDTs alone while they focused on tools with an apparently greater potential for harm, such as malfunctioning pacemakers.

After researchers developed new genetic engineering techniques in the 1990s, however, the possibilities for LDTs expanded dramatically. Whereas previous generations of LDTs looked for a handful of unusual proteins, for example, some of the newly emerging genetic tests could sort through any number of the three billion base pairs, or letters, of the DNA alphabet found in the human genome, looking for abnormalities related to disease. In addition, testing became automated, making LDTs increasingly easier to design and use.

The improved technology led to an enormous rise in the number and variety of LDTs that came to market. By some estimates, about 11,000 labs now offer between 60,000 and 100,000 of them; no one knows precisely how many because, of course, these tests do not have to be registered anywhere.

Under current federal regulations, LDTs enjoy a big loophole, which means they do not have to be evaluated for their medical usefulness. Nor are they required to have research about them made public. The lab that created them does need to meet certain fundamental standards of scientific practice. But the FDA does not vet the tests either before or after doctors can start ordering them for patients, as it does for most prescription drugs or medical devices.

This loophole means that companies ranging from small start-ups offering just one or two tests to much larger diagnostic labs that offer thousands of tests can develop and charge for new LDTs much more easily than they can for most other categories of medical products. With the rise in the number of tests has come a series of reports showing that certain ones have already hurt people by delivering misleading results.

Clinical Validity

The FDA has cited 20 different types of LDTs as especially troubling, including Lyme disease and whooping cough tests that regularly give wrong answers and LDTs that purport to determine a woman’s risk for ovarian cancer such as by measuring the presence of the protein CA 125 in the blood. In September the agency concluded that screening measures for this protein offered “no proven benefit” and warned physicians against recommending or using them.

Many of the tests that have raised the FDA’s ire may indeed measure what they claim to measure. The problem is that the measured substance may not be a good indicator of a specific medical problem. In the case of the ovarian cancer tests, for instance, high levels of CA 125, which is made in the ovaries, should in theory signify the presence of extra ovarian cells—in other words, the presence of a tumor. In reality, it turns out that many women with high levels of CA 125 do not have ovarian cancer, and, conversely, many women with cancer do not have high levels of CA 125. Thus, measures of CA 125 cannot be trusted to give an accurate diagnosis of cancer—and yet a number of women who tested positive apparently feared the possibility of cancer so much that they decided to have their healthy ovaries removed anyway.

One way that investigators determine whether a medical test should be used as a guide to a patient’s condition is by applying a somewhat obscure statistical ratio called a positive predictive value, or PPV. This measure takes into account just how common a condition might be in a given group of people.

Why such a consideration would be important in determining a test’s usefulness may be best understood by analogy. If you drop a baited hook into a barrel full of fish, the chances that a tug on the line means that you have caught a fish are pretty high. On the other hand, dropping the same baited hook into a freshwater lake that has not been stocked with fish makes it much less likely that any given tug on the line represents a fish, as opposed to, say, a tree snag. Because the barrel contains many more fish for a given volume of water than the lake does, a tug in the container has a PPV close to 100 percent, whereas that of a tug in an unstocked lake is much less than 100 percent.

This crucial statistical distinction explains the problem the FDA has with one current ovarian screening test, which its developer claimed had a PPV of 99.3 percent. Closer analysis by independent biostatisticians revealed, however, that the value was calculated on the basis of a single experiment in which half the patients were already known to have ovarian cancer—a highly selected group that is the medical equivalent of a stocked pond.

When the researchers recalculated the PPV using ovarian cancer’s true frequency in the general U.S. population of one case for every 2,500 postmenopausal women, the PPV plummeted to just 6.5 percent. In other words, only one in every 15 patients who received a positive result from this malignancy test would have actually had ovarian cancer. The other 14 would, if they had relied on this test alone, very likely have undergone unnecessary operations to remove their otherwise healthy ovaries because they would have mistakenly believed they had a 99.3 percent chance of having cancer.

Changing Focus

Because the FDA does not have the resources to oversee all the LDTs that have come to market in recent years, the agency plans to divide them into three categories, based on the likelihood that a misleading or incorrect result from a particular test could cause substantial harm. Under the new guidelines, LDTs would be considered high risk if inaccurate results could lead to death or prolonged disabilities. Such tests would come under the greatest inspection, information about them would need to be entered in a national database, and manufacturers would have to prove their safety and efficacy to the FDA before they could be sold. “Basically, the FDA wants to see the supporting evidence before it allows a high-risk LDT to go out on the market,” says Joshua Sharfstein, a physician and professor at the Johns Hopkins Bloomberg School of Public Health.

Even this targeted approach worries many industry leaders and some professional medical societies, including the American Medical Association. “It really depends on how the FDA chooses to define high risk, and that currently isn’t clear,” says Curtis Hanson, chief medical officer at Mayo Medical Laboratories in Rochester, Minn., which conducts 25 million lab tests a year. “High-risk tests could amount to between 1 and 10 percent of LDTs on the market today. How is the FDA going to review and find the rare cases where you have problems and do that in an efficient way that doesn’t slow progress?”

For patients and their physicians, the question is much more basic. Why should they ever have to wonder whether a commercially available medical test does more harm than good?

This article was originally published with the title “When Medical Tests Mislead”

 

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

Print Friendly
November, 2016|Oral Cancer News|

For this cancer, ‘stage 4’ isn’t as bad as it sounds

Source: www.omaha.com
Author: Steve Hendrix – The Washington Post

Hearing the word “cancer” in a doctor’s office is bad enough. Hearing “stage 4” invokes even more dread. When I learned I had stage 4 HPV-related oral cancer, I didn’t know exactly what it meant, but I knew there wasn’t a stage 5.

Doctors use the standardized staging system to describe the location, size and extent of a cancer and its spread throughout the body. Using data on the treatment and survivability of each particular kind of cancer, clinicians combine these factors to produce a number from stage 1 (a small tumor confined to one spot) to stage 4 (a cancer that has spread, either to a single adjacent lymph node or to distant organs).

My cancer was stage 4A, a small tumor at the base of my tongue that had spread to a single lymph node in my neck.

My doctor immediately tried to soften the blow. There were problems with the staging rules as they applied to this kind of cancer, he said. HPV oropharyngeal cancers, while potentially fatal, were far more treatable than other oral cancers, particularly the ones related to tobacco and alcohol use that were used to define the staging standards.

He was right. A study published in the Lancet early this year found that the current guidelines lead to needless panic for the newly diagnosed. “At the present time, most patients with HPV+ oropharyngeal cancer are told they have (stage 4) disease, but the reality is that their outlook is similar to that of patients with the most curable malignant diseases,” the study authors wrote.

This month, the American Joint Committee on Cancer is releasing new guidelines for HPV-positive oropharyngeal cancer staging that will ease patient fears and make it easier for doctors to offer less-invasive treatment options.

“It’s remarkable,” said my own physician, Arjun Joshi of George Washington University. “Under the new system, you would only be a stage 1.”

Print Friendly
November, 2016|Oral Cancer News|

E-cigarettes ‘just as harmful as tobacco’ for oral health

Source: www.medicalnewstoday.com
Author: Honor Whiteman

Electronic cigarettes are often marketed as a safer alternative to conventional cigarettes. When it comes to oral health, however, new research suggests vaping may be just as harmful as smoking.

a-woman-using-an-ecigarette

Researchers suggest vaping may be equally – if not more – harmful for oral health than smoking.

In a study published in the journal Oncotarget, researchers found that the chemicals present in electronic cigarette (e-cigarette) vapor were equally as damaging – in some cases, more damaging – to mouth cells as tobacco smoke.

Such damage can lead to an array of oral health problems, including gum disease, tooth loss, and mouth cancer.

E-cigarettes are battery-operated devices containing a heating device and a cartridge that holds a liquid solution. The heating device vaporizes the liquid – usually when the user “puffs” on the device – and the resulting vapor is inhaled.

While e-cigarette liquids do not contain tobacco – a highly harmful component of conventional cigarettes – they do contain nicotine and other chemicals, including flavoring agents.

According to the Centers for Disease Control and Prevention (CDC), the use of e-cigarettes has increased in recent years, particularly among young people. In 2015, 16 percent of high-school students reported using the devices, compared with just 1.5 percent in 2011.

E-cigarettes are considered by many to be safer than conventional smoking, but because the devices are relatively new to the market, little is known about the long-term effects of vaping on health.

In particular, study leader Irfan Rahman, Ph.D., professor of environmental medicine at the University of Rochester School of Medicine and Dentistry in New York, and colleagues note that there has been limited data on how e-cigarette vapor affects oral health.

Flavored vapor worsens damage to gum tissue cells
To address this gap in research, the team exposed the gum tissue of nonsmokers to either tobacco- or menthol-flavored e-cigarette vapor.

The tobacco-flavored vapor contained 16 milligrams of nicotine, while the menthol flavor contained 13-16 milligrams of nicotine or no nicotine.

The researchers found that all e-cigarette vapor caused damage to gum tissue cells comparable to that caused by exposure to tobacco smoke.

“We showed that when the vapors from an e-cigarette are burned, it causes cells to release inflammatory proteins, which in turn aggravate stress within cells, resulting in damage that could lead to various oral diseases.” said Irfan Rahman, Ph.D.

The researchers note that nicotine is a known contributor to gum disease, but e-cigarette flavoring appeared to exacerbate the cell damage caused by e-cigarette vapor, with menthol-flavored vapor posing the most harm.

While further research is needed to investigate the long-term effects of e-cigarette use, Rahman and team believe their findings indicate that the devices may have negative implications for oral health.

“Overall, our data suggest the pathogenic role of [e-cigarette] aerosol to cells and tissues of the oral cavity, leading to compromised periodontal health,” they conclude.

E-cigarette vapor damaged, killed 53 percent of mouth cells in 3 days
Another study recently published in the Journal of Cellular Physiology builds on the findings from Rahman and colleagues, after finding a high rate of mouth cell death with exposure to e-cigarette vapor over just a few days.

To reach their findings, Dr. Mahmoud Rouabhia, of the Faculty of Dental Medicine at Université Laval in Canada, and colleagues placed epithelial cells from the mouth in a chamber that contained a liquid similar to saliva.

To simulate vaping, the researchers pumped e-cigarette vapor into the chamber at a rate of two 5-second puffs every 60 seconds for 15 minutes a day. This was performed over 1, 2, or 3 days.

On analyzing the vapor-exposed epithelial cells under a microscope, the researchers identified a significant increase in the rate of cell damage and death.

The rate of damage or death in unexposed cells is around 2 percent, the researchers note. However, they found that with exposure to e-cigarette vapor, the number of dead or dying cells rose to 18 percent, 40 percent, and 53 percent over 1, 2, and 3 days, respectively.

While the cumulative effects of the cell damage caused by e-cigarette are unclear, the researchers believe their findings are a cause for concern.

“Damage to the defensive barrier in the mouth can increase the risk of infection, inflammation, and gum disease. Over the longer term, it may also increase the risk of cancer. This is what we will be investigating in the future.” said Dr. Mahmoud Rouabhia

Print Friendly
November, 2016|Oral Cancer News|

Curbing oral cancer

Source:.businessmirror.com.ph
Author: Henrylito D. Tacio

“Cancer is the third leading cause of death in the country today. Most of it can be prevented since its risk factors are lifestyle and environmentally related. Early detection of cancer is a crucial key to the survival and recovery of its victims. The earlier you detect the malignancy the higher the survival rate of the patient.”
—Dr. Vic Fileto Chua of Movement for Early Detection of Cancer

What’s the leading cause of oral cancer? Is it smoking or heavy drinking? Although smoking and drinking may cause oral cancer, the leading cause is oral sex, a sexual act that involves the stimulation of the genitalia using the mouth.

Studies have shown that 64 percent of cancers of the oral cavity, head, and neck in the United States are caused by human papillomavirus (HPV), which is commonly spread via oral sex. The more oral sex you have – and the more oral sex partners you have – the greater the risk of developing these potentially deadly cancers.

oral_cancer

“An individual who has six or more lifetime partners—on whom they’ve performed oral sex—has an eightfold increase in risk compared to someone who has never performed oral sex,” explained Dr. Maura Gillison, an oncologist at Ohio State University. Gillison headed a team of researchers who examined 271 throat-tumor samples collected over 20 years ending in 2004. They found that the percentage of oral cancer linked to HPV surged to 72 percent from about 16 percent.

The study, which was published in the Journal of Clinical Oncology, said that by 2020, the virus-linked throat tumors—which mostly affected men—will more common than HPV-caused cervical cancer.

“The burden of cancer caused by HPV is going to shift from women to men in this decade,” observed Gillison. “What we believe is happening is that the number of sexual partners and exposure to HPV has risen over that same time period.”

In his weekly column in Philippine Daily Inquirer, Dr. Rafael D. Castillo noted: “Previously, it was well established that smoking (three-fold increase) and drinking alcohol (2.5 times) increased the risk for oral cancer, but even if you combine them, the risk is no match compared to that seen in those who frequently engage in oral sex.”

The government doesn’t have any data on the prevalence of oral cancer in the country but what alarms Castillo is that oral cancer might be rampant among young people. A study done by the University of the Philippines Population Institute showed that more than four million teenagers and young Filipinos are already engaged in sexual practices.

The findings of the third Young Adult Fertility Survey revealed that a total of 4.32 million Filipinos aged 15 to 24 are already sexually active. Another finding is that oral sex has become a common practice “among most sexually adventurous teens.”

“Doing simple math, if the expected prevalence of oral cancer in the general population is 1.5 percent, and with a nine-fold increase in risk, that means that we have approximately 583,000 young Filipinos aged 15 to 24 who are likely candidates to develop oral cancer,” Dr. Castillo surmised.

“Today’s teens consider oral sex to be casual, socially acceptable, inconsequential, and significantly less risky to their health than ‘real’ sex,” said Gillison. Teens simply think oral sex is “not that a big a deal,” added Dr. Bonnie Halpern-Felsher, professor of pediatrics at the University of California, San Francisco. “Parents and health educators are not talking to teens about oral sex. Period.”

Members of the Philippine Medical Association (PMA) and the Philippine Dental Association (PDA) also noted that the practice of oral sex can lead to infections of the oral cavity, which may result to cancer of the tonsils, tongue or throat.

“Any lesion in the mouth should be seriously considered,” said Dr. Anne Camus, PDA’s Manila dental chapter president. “Not all can develop to cancer but malignancy must always be taken as an imminent possibility.”

A regular check-up with a dentist would help detect malignancies in the mouth. “The dentists are usually the first to see lesions in the mouth of our patients,” Camus said. “At this early point, if the lesion turns out to be malignant, then chances are it is still curable.”

Oral cancer, or cancer of the mouth, most commonly involves the lips or the tongue. It may also occur on the: cheek lining, floor of the mouth, gums, and roof of the mouth (palate). Most oral cancers are a type called squamous cell carcinomas, which tend to spread quickly.

Aside from oral sex, smoking, and drinking, other factors that add to the risk of oral cancer include repeated irritation from the sharp edges of broken teeth, fillings, or dental prostheses (dentures). “The research regarding their involvement is uncertain. It is likely that there is a complex interaction of many external and internal factors that play a role in the development of oral cancer,” points out the Oral Cancer Foundation in the United States.

“Oral cancers are usually painless for a considerable length of time but eventually do cause pain,” notes “The Merck Manual of Medical Information.” “Pain usually starts when the cancer erodes into nearby nerves. When pain from cancer of the tongue or roof of the mouth begins, it usually occurs with swallowing as with a sore throat.”

The early growth of salivary gland tumors may or may not be painful. “When these tumors do become painful, the pain may be worsened by food, which stimulates the secretion of saliva,” the Merck manual informs. “Cancer of the jawbone often causes pain and a numb or pins-and-needles sensation, somewhat like the feeling of a dental anesthetic wearing off. Cancer of the lip or check may first become painful when the enlarged tissue is inadvertently bitten.”

Discolored areas on the gums, tongue, or lining of the mouth may be signs of cancer. “An area in the mouth that has recently become brown or darkly discolored may be a melanoma (malignant tumor),” the Merck manual states. “Sometimes, a brown, flat, freckle-like area (smoker’s patch) develops at the site where a cigarette or pipe is habitually held in the lips.”

“Keep in mind that your mouth is one of your body’s most important early warning systems,” reminds the Oral Cancer Foundation. “Don’t ignore any suspicious lumps or sores. Should you discover something, make an appointment for a prompt examination. Early treatment may well be the key to complete recovery.”

According to the US National Cancer Institute, oral cancer treatments may include surgery, radiation therapy or chemotherapy. Some patients have a combination of these treatments.

Print Friendly
November, 2016|Oral Cancer News|

HPV and mouth cancer

Source: www.hippocraticpost.com
Author: Thea Jourdan

hpv

Mouth cancer kills nearly 2000 people in the UK each year. The Human Papilloma Virus (HPV) of which there are over 100 different types, is more commonly associated with cervical cancer and genital warts, but it can also cause oral cancer, particularly of the back of the tongue and tonsils. The virus incorporates itself into the cell’s DNA and causes the cell to multiply out of control, leading to cancer.

In Britain, the number of mouth and throat cancers have increased by 40 per cent in just a decade, to 6,200 cases a year. According to Cancer Research UK, the HPV virus, which is transmitted to the mouth region from the genitals during oral sex, may be key to the ‘rapid rise’. Statistics also show that the more sexual partners you have the greater your chance of acquiring mouth cancer.

“There is now scientific evidence that a proportion of mouth and throat cancers are linked to HPV infection,” says Hazel Nunn, head of health information at Cancer Research UK. “We know that HPV is found in the mouth but we do not yet know how it gets there – whether through oral sex or otherwise. HPV virus has been found on the fingers and elsewhere on the body. It is possible that oral sex is having an impact but more research needs to be done into the kinds of behaviour that leads to this infection.”

“HPV has been causing mouth cancer for decades but the link is only now becoming clear. HPV is a hardy virus that likes sitting in lymphoid tissue wherever it is in the body,” explains Professor Mark McGurk, a senior consultant ENT surgeon based at London Bridge Hospital in London. That means it thrives in the lymphoid tissue in the mouth, including that of the tonsils and at the base of the tongue. For the same reason, it settles in the cervix, the vulva and around the anus.

For many people, HPV won’t cause any problems at all. “In fact, we know that 80 per cent of women and men will have the HPV infection at some time in their lives and clear it themselves without any symptoms,” explains Mr Mike Bowen, a consultant obstetrician and gynacologist based at St John and St Elizabeth Hospital in London. “But for a few it can cause cellular changes that lead to cancer.”

Professor McGurk says that over the last 30 years, he has seen a rise in oropharyngeal cancer, which typically affects sexually active men in their 50s and 60s. “They may have been infected with the virus for some time and ,” he explains. The cancer reveals itself as growths on the tonsils and back of the tongue.

Many patients are only diagnosed at the late stage of their disease. Michael Douglas, the actor, already had stage 4 cancer when his cancer was recognized. Fortunately, oral cancer caused by HPV is very treatable, even when it is very advanced, using radiotherapy. “We used to do surgery on these cases, but we don’t need to anymore. In many cases, the cancer simply melts away with radiotherapy,” explains Professor McGurk. Patients with stage 1 and 2 Oral cancer caused by HPV have an 85 per cent chance of surviving for 5 years after treatment, and patients with stage 4 disease have a 60 per cent chance of surviving five years – impressive compared to the survival rates for other types of oral cancer where overall survival is 50 per cent over 5 years. [Cancer Research UK]

Cancer research UK is pushing for all mouth tumors to be tested to see if they are HPV positive, to assist with effective treatment of patients. “At the moment, it varies massively depending on what hospital you are in. We think it should be standard,” says Hazel Nunn.

Professor McGurk believes there is a simple explanation why men are more likely to have HPV in their mouths than women. “Women harbor the virus in their genitalia which provides a hospitable environment while the male penile area is a relatively hostile area for the virus to settle.”

One way to try and turn the tide would be to introduce a HPV vaccination for boys and girls before they become sexually active. Girls from the age of 12 in the UK have been offered vaccinations since 2008 against the two most common strains of HPV -16 and 18- which are linked to cervical cancer.

Boys are not offered the vaccine, but this should change, according to Professor Margaret Stanley, a virologist based at Cambridge University who believes that boys must be given the vaccine for HPV too from the age of 12 or 13.

‘Obviously cervical cancer is the big one but the other cancers – cancers of the anus and increasingly the tonsil and tongue – there is no screening for them and no way of detecting them until they are proper cancers and they are more common in men than in women.’

Hazel Nunn of Cancer Research UK points out that there is no evidence that vaccinating boys will help protect them from oral cancer. “It is theoretically possible but there have been no trials that had this as an end point. There is a danger that we get too far ahead of ourselves without evidence-based medicine.”

She insists that although HPV is a worrying factor, by far the most significant risks associated with mouth and throat cancers of all types are smoking and alcohol. “

Print Friendly
November, 2016|Oral Cancer News|

Tobacco is OUT! A third of all Major League Baseball stadiums to be free of tobacco

Source: www.dailyastorian.com
Author: American Heart Association News

With the end of this baseball season, so ended the long intertwined history of tobacco and baseball at more than one-third of all Major League stadiums.

The unhealthy coupling started unraveling when it became evident that chewing tobacco resulted in deadly consequences for some players, such as legendary San Diego Padre Tony Gwynn who died of mouth cancer in 2014.

Just months after Gwynn’s death, former Boston Red Sox pitcher Curt Schilling announced he was being treated for oral cancer.

Although Major League Baseball and the players’ union could not agree to take action, several cities have. Boston, Chicago, Los Angeles, New York and San Francisco all have passed laws prohibiting tobacco use of any kind at sports venues. A statewide law in California will take effect before the 2017 season begins.

This week, the Washington, D.C. City Council gave final approval to a measure that would end the use of all tobacco products – including smokeless tobacco like chew, dip and snuff – at all organized sporting events within the city, including Nationals Park.

Councilmember Yvette Alexander said the move is needed to help protect children, who often look to sports professionals as role models, from taking up the habit. The measure will now be sent to Mayor Muriel Bowser to sign into law.

Additionally, on Oct. 20, St. Petersburg, Florida, City Council Vice Chair Darden Rice introduced a proposal to ban smokeless tobacco products from the city’s athletic venues. The proposal includes Tropicana Stadium, the home of the Tampa Bay Devil Rays. Rice said she hopes the proposal would clear before the start of the 2017 season.

Legislation is also currently under consideration in Toronto and the state of Minnesota.

“Our national pastime should be about promoting a healthy and active lifestyle, not a deadly and addictive product,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

Print Friendly
November, 2016|Oral Cancer News|

We Now Know Exactly How Many DNA Mutations Smoking Causes

Every 50 cigarettes you smoke gives you one extra DNA mutation per lung cell.

large

Source: The Verge
Author: James Vincent

A common tactic for people trying to give up smoking is to quantify exactly how much damage — financial or physical — each cigarette or pack of cigarette does. How much does smoking cost you per month, for example, or how much shorter is your life going to be for each drag you take? Well, a new study into the dangers of smoking now lets us measure this damage right down to the number of mutations in your DNA.

A research team led by scientists from Los Alamos National Laboratory compared tissue samples from 1,063 non-smokers and 2,490 smokers, examining each individual’s DNA to look for mutations. They found that for every 50 cigarettes smoked, there is one extra DNA mutation for each cell in the lungs. Over the course of a year, this means that someone who smokes a pack a day (20 cigarettes) has 150 extra mutations per cell in the lung, 97 per larynx cell, 23 per mouth cell, 18 per bladder cell, and six per liver cell.

These changes to the cells aren’t dangerous in themselves, but each one has the potential to turn into a cancerous growth. “Smoking is like playing Russian roulette: the more you play, the higher the chance the mutations will hit the right genes and you will develop cancer,” Ludmil Alexandrov, the co-lead author of the study, told the New Scientist. “However, there will always be people who smoke a lot but the mutations do not hit the right genes.”

The reason for all these extra mutations is found in tobacco smoke — a substance that contains some 7,000 different chemicals, over 70 of which are known to cause cancer. How exactly different types of cell mutations lead to cancer is less clear, and the team from Los Alamos are hoping next to drill down further into this line of research and find out the probabilities that any individual DNA mutation will turn into cancer.

The good news for smokers, though, is that it’s never too late to quit. Although smoking causes regular DNA mutations, as soon as people give up cigarettes, the mutations stop too. One UK study from 2004 found that those who quit smoking at age 30 nearly eliminate the risk of dying prematurely, while those who quit at 50 halve it. For people trying to give up, those are certainly some more comforting odds.

 

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

Print Friendly
November, 2016|Oral Cancer News|

Smokeless Tobacco Use and the Risk of Head and Neck Cancer: Pooled Analysis of US Studies in the INHANCE Consortium.

Source: www.pubmed.gov
Author: Wyss AB, Gillison ML, Olshan AF

Abstract

Previous studies on smokeless tobacco use and head and neck cancer (HNC) have found inconsistent and often imprecise estimates, with limited control for cigarette smoking. Using pooled data from 11 US case-control studies (1981-2006) of oral, pharyngeal, and laryngeal cancers (6,772 cases and 8,375 controls) in the International Head and Neck Cancer Epidemiology (INHANCE) Consortium, we applied hierarchical logistic regression to estimate odds ratios and 95% confidence intervals for ever use, frequency of use, and duration of use of snuff and chewing tobacco separately for never and ever cigarette smokers. Ever use (versus never use) of snuff was strongly associated with HNC among never cigarette smokers (odds ratio (OR) = 1.71, 95% confidence interval (CI): 1.08, 2.70), particularly for oral cavity cancers (OR = 3.01, 95% CI: 1.63, 5.55). Although ever (versus never) tobacco chewing was weakly associated with HNC among never cigarette smokers (OR = 1.20, 95% CI: 0.81, 1.77), analyses restricted to cancers of the oral cavity showed a stronger association (OR = 1.81, 95% CI: 1.04, 3.17). Few or no associations between each type of smokeless tobacco and HNC were observed among ever cigarette smokers, possibly reflecting residual confounding by smoking. Smokeless tobacco use appears to be associated with HNC, especially oral cancers, with snuff being more strongly associated than chewing tobacco.

© The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved.

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

Print Friendly
October, 2016|Oral Cancer News|

America’s Most Popular ‘Legal’ Drug is Responsible for 25% of ALL Cancer

Source: www.thefreethoughtproject.com
Author: John Vibes

There are many factors contributing to the massive rise in cancer cases in the US, but according to a new study from the American Cancer Society, cigarette smoke is by far the leading cause. The study found that roughly 25% of all cancer deaths could be attributed to cigarette smoking.

Although cigarette smoking has waned somewhat in recent years, nearly 40 million adults in the U.S. currently smoke cigarettes. The CDC says cigarette smoking is the leading cause of preventable disease and death in the U.S., responsible for more than 480,000 deaths annually.

According to the study:

We estimate that at least 167133 cancer deaths in the United States in 2014 (28.6% of all cancer deaths; 95% CI, 28.2%-28.8%) were attributable to cigarette smoking. Among men, the proportion of cancer deaths attributable to smoking ranged from a low of 21.8% in Utah (95% CI, 19.9%-23.5%) to a high of 39.5% in Arkansas (95% CI, 36.9%-41.7%), but was at least 30% in every state except Utah. Among women, the proportion ranged from 11.1% in Utah (95% CI, 9.6%-12.3%) to 29.0% in Kentucky (95% CI, 27.2%-30.7%) and was at least 20% in all states except Utah, California, and Hawaii. Nine of the top 10 ranked states for men and 6 of the top 10 ranked states for women were located in the South. In men, smoking explained nearly 40% of cancer deaths in the top 5 ranked states (Arkansas, Louisiana, Tennessee, West Virginia, and Kentucky). In women, smoking explained more than 26% of all cancer deaths in the top 5 ranked states, which included 3 Southern states (Kentucky, Arkansas, and Tennessee), and 2 Western states (Alaska and Nevada).

Smoking is one of the leading causes of illness and death in the world. The use of tobacco has become more widespread than ever and the substance itself is far more dangerous than it has ever been before.

Today, cigarettes are mass produced and treated with thousands of additives and chemicals. Carcinogenic, poisonous chemicals and toxic metals can all be found in modern tobacco products. These chemicals are present for many reasons ranging from taste and preservation to being purposely addictive. There are over 4000 of these chemicals in cigarettes and all of them are not revealed to the public. They are protected under law as “trade secrets” — meaning they can add anything they want in there without our knowledge.

The financial advantage alone should be enough of an argument to quit smoking. In most states, cigarettes are now over 6 dollars a pack, more than half of which is taxes. So people are literally paying the government and rich multinational corporations an average of 10 dollars every day, for a product that destroys their bodies. It is true that there are addictive chemicals in cigarettes but their strength and power has been blown way out of proportion.

The psychological addiction is always much stronger than the physical addiction even with harsh narcotics like heroin and especially with nicotine. All you have to do is stop and get through a few days without it. Soon enough the smell and taste will no longer be desirable to you and you will be happy to have that extra 6 dollars a pack in your pocket. It will be easier to breathe, you won’t get sick as often and you will overall be in better spirits. Quitting cigarettes is one decision that you can make that will drastically improve your life in a number of ways and it will give the elite less control of your money and your health.

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

Print Friendly
October, 2016|Oral Cancer News|

GlaxoSmithKline pulls Cervarix from U.S. market

Source: www.managedcaremag.com
Author: staff

In response to “a very low market demand,” GlaxoSmithKline has decided to stop selling its human papillomavirus (HPV) vaccine Cervarix in the United States, according to FiercePharma. The move gives Merck’s Gardasil unchallenged dominance of the HPV vaccine market in this country.

Last year, Cervarix earned only about $3.7 million in the U.S. out of a $107 million worldwide total. In contrast, the global total for Merck’s Gardasil franchise was $1.9 billion.

Figures from the Centers for Disease Control and Prevention (CDC) last year placed HPV vaccination rates at 42% of girls and 28% of boys ages 13 to 17 years––far short of the U.S. Department of Health and Human Services’ goal of 80% for both boys and girls by 2020.

To combat the public’s lukewarm response, the CDC and other cancer organizations are urging health care providers to promote the cancer-prevention benefits of HPV vaccines rather than stressing that they protect against sexually transmitted infections, which puts off some parents who worry the vaccine will promote promiscuity or who feel that their preteens are too young to need the shots, according to the Wall Street Journal.

HPV, which is transmitted sexually, can cause at least six types of cancer as well as genital warts. The vaccine is recommended for boy and girls at age 11 or 12 and is also given at other ages.

Experts are urging pediatricians to present the vaccine as routine, rather than different from other preteen shots. They are also stressing completion of the vaccine series by age 13.

Merck, the maker of Gardasil, is currently airing an ad on national television that puts the onus on parents to get their children vaccinated.

Sources: FiercePharma; October 21, 2016; and Wall Street Journal; October 17, 2016.

Print Friendly
October, 2016|Oral Cancer News|