Monthly Archives: November 2008

10 years after settlement, tobacco rebounds in US

Author: Bruce Schreiner and Emery P. Dalesio

Lindsay Pasley is an eager young man in what used to be an older man’s game — tobacco farming.

He recently took 20 tons of his early prepared leaf to Clay’s Tobacco Warehouse in Mount Sterling, due east of Lexington in the Appalachian foothills, where he said he earned enough to “have a nice Thanksgiving and Christmas.”

The auctioneer’s singsong chant still rings out at Clay’s and a few other tobacco-selling sites stubbornly hanging on with limited sales, but not nearly as often.

Clay’s is the last tobacco warehouse standing in Mount Sterling, once home to four. Owner Roger Wilson, who has watched as longtime growers have switched crops or quit farming altogether over the years, hopes to sell more than 2 million pounds this season, comparable to last year but down about half from the days before Congress pulled the plug on a Depression-era buyout program.

Yet Pasley, 28, wants to quadruple his acreage. He has a contract to sell 10 times as much to R.J. Reynolds Tobacco Co. as he did at the auction.

A decade ago, tobacco seemed destined to wither as cigarette companies shelled out tens of billions to settle lawsuits with states. Smoking bans then swept the country and — worst of all for the small-time grower — Congress cut off the quota system four years ago.

As a rebound in production this year shows, however, Big Tobacco and individual growers alike have proven as resilient as their leaf, aided by a boost in exports primarily to Germany and Switzerland and by new marketing tactics emphasizing smokeless options.

According to the U.S. Department of Agriculture, production of all tobacco varieties fell 27 percent to 640 million pounds in 2005, the first year without the price support program, which entitled license-holders to a quota of the total tobacco crop capped by the USDA each year. The venerable program was reeling from steep declines in tobacco demand due to anti-smoking efforts.

This year, production climbed to 805 million pounds — within 10 percent of the 2004 level of 882 million pounds. That 2004 output was half the production in 1997 and a third of 30 years earlier. The bottom came in 2005, when growers produced 645 million pounds.

The uptick has coincided with the increasing consolidation of growing onto fewer farms.

“We’ve had so many to drop out, that for the ones who stay in there are opportunities,” said Will Snell, a University of Kentucky agricultural economist.

Production of burley leaf, which accounts for about a quarter of all tobacco production in the United States, has lost about three-fourths of its growers since the buyout, Snell said. Yet some operations now cover hundreds of acres, a big undertaking when much of the work is still done by hand.

In 2004, the last year of the federal price-support program, there were nearly 26,000 farms with quota licenses to grow the more common flue-cured tobacco in North Carolina, still the nation’s top tobacco-growing state. By this year, that was down to 2,500 to 3,000 farms, said Scott Bissette of the state agriculture department’s tobacco marketing division.

U.S. tobacco production was valued at $1.3 billion in 2007, off from $1.75 billion in 2004, according to the USDA. Domestic cigarette sales are falling by 3 percent to 4 percent a year, a decline that has worsened since the quota system ended. Smokers have felt increased pressure to quit due to smoking bans and higher prices, on top of the longstanding health concerns and the social stigma.

The top two U.S. cigarette makers — Philip Morris USA and Reynolds American Inc. — are aggressively searching for a smokeless product that consumers will like. They are focusing on cigars, moist snuff, chewing tobacco and snus, which comes in tea bag-like pouches that users stick between the cheek and gum.

To move beyond cigarettes, Altria Group Inc. bought John Middleton Inc., the maker of convenience-store staple Black & Mild cigars, last year. Its pending acquisition of UST Inc., whose Skoal and Copenhagen brands make it the U.S. market leader in smokeless tobacco, is expected to close during the first week in January.

Winston-Salem, N.C.-based Reynolds bought the Conwood smokeless tobacco business in 2006 and sells moist snuff under the Grizzly brand.

Richmond, Va.-based Altria, which also owned Marlboro-maker Philip Morris International, spun it off as an independent company in March. It has since shifted the production of 57 billion cigarettes to overseas factories, but it still buys tobacco grown in the U.S., spokesman Greg Prager said.

Prager said Philip Morris International, the world’s biggest nongovernmental tobacco company, also buys tobacco from Brazil, Malawi, Italy, Greece, Turkey and other countries. He said U.S. tobacco remained a key component of the company’s international blends, though he declined to specify how much is bought from U.S. sources, citing competitive reasons.

Exports of U.S. tobacco have played a big role in the crop’s rebound. Foreign sales peaked in 1978 at 700 million pounds, but the price supports meant American farmers were undercut by developing countries such as Zimbabwe and Malawi selling tobacco for as little as a third of the U.S. cost. U.S. exports slid to about 339 million pounds in 2005 before rising again to 398 million pounds in 2006, the USDA said.

The rebound was due to a weak dollar and rising currencies overseas, said Blake Brown, a North Carolina State University agricultural economist.

In recent months, a strengthening dollar along with a rebound in tobacco production in South America and Africa are causes for concern for export prospects, Snell said. And profit margins remain tight for farmers because of rising costs, Snell said. Whether tobacco companies offer price incentives will be crucial in determining how much U.S. tobacco is grown, he said.

“Today’s farmers are not like yesterday’s farmers — that since they grew tobacco last year they’re going to grow it next year,” Snell said. “These farmers will look at the market opportunities year to year.”

Still, the U.S. is expected to remain the world’s fourth-largest tobacco grower throughout this decade, trailing China, India and Brazil, according to the United Nations. Not only has tobacco production expanded outside the Southeast to places like Pennsylvania and Missouri, but farmers are feeling better about their prospects.

In 2004, 69 percent of North Carolina growers in one survey said they saw a future in tobacco. Two years into the buyout experience it was 76 percent, according to the research conducted under National Cancer Institute grants. About a third of farmers said in 2006 they would advise their children to grow tobacco, up from about one-fifth in 2004.

Pasley said he expects to produce about 500,000 pounds of burley this year, and that he would have produced another 150,000 pounds if he’d gotten more rain.

“My goal is to sell 1 million pounds before I turn 30,” he said.

As he sees it, the best thing tobacco has going for it is demand.

“People always chew and smoke,” he said.

November, 2008|Oral Cancer News|

Cancer survivor is again living the life of a teenager

Author: Julie Muhlstein

Mark Edmondson doesn’t ask “Why me?” The 18-year-old has endured more pain than most people suffer in a long lifetime.

“I’m still alive,” the Everett High School senior said Monday. “I appreciate a lot of things now most teenagers don’t.”

Two years ago today, when Edmondson was featured in this column, he’d just been diagnosed with an aggressive type of mouth cancer. He’d survived grueling surgery. Still ahead were months of chemotherapy and radiation.

At 16, as friends were staring to drive and enjoying high school, his future looked bleak. With every reason for self-pity, he never let himself sink.

“Never,” said his mother, Stephanie Edmondson. “There’s no complaining, no whining, no ‘Why me?’ He’s always been like that. He has kind of an old soul. I’m very proud of him,” she said.

She is also thankful beyond words. Today, Mark Edmondson is strong and fit. He missed a year of school, but is on track for June graduation. He works out at the YMCA and has two jobs. He looks forward to Thanksgiving with his mother, younger brother John, grandmother Celeste Berdahl and extended family.

Just a year ago, Mark had a feeding tube. At 5 feet, 10 inches tall, his mother said, he weighed 104 pounds. He finished radiation treatments at Seattle’s Swedish Medical Center in the spring of 2007. Since then, scans and biopsies have shown that he’s cancer-free. But last fall he suffered an intestinal infection. “He did not look like he was going to make it,” Stephanie Edmondson said.

Once he was able to eat normally, he began to reclaim the life of a teenager. He’s now a muscular 180 pounds. He splits his time between school, workouts and work at a Safeway store and a Subway shop.

“At Everett High, he’s taking the world by the tail,” said Berdahl, 75, who lives with the family. “His hair is all back and he’s all muscle. He eats everything he’s supposed to, no pop and no junk food.”

Mark Edmondson never had risky habits common to sufferers of his type of cancer, oral squamous cell carcinoma.

“Ninety-nine percent of my patients smoke and drink, or they did,” said Dr. David Moore, Mark’s surgeon at Swedish Medical Center. His specialty is otolaryngology, or head and neck surgery.

Moore said his teen patient had neither smoked nor used chewing tobacco. “You run into this sometimes. We don’t quite understand why their immune system allowed this,” said Moore, adding that it’s rare to see this cancer in someone so young.

“I think he’s done amazingly well,” the doctor said. “We’ll follow him for five years, and after five years you’re considered cured. To date, there is no evidence of recurrence.”

Stephanie Edmondson said they heard during the darkest times that Mark’s chance of survival was as low as 10 percent. Edmondson’s oncologist at Swedish, Dr. Gary Goodman, was unavailable to comment. Moore said he prefers to stay away from discussing odds. “I just tell my patients this is something that can be cured,” he said.

Moore said he had no choice but to be honest with the teen about his prognosis. “You can’t look somebody in the eye and not tell him the truth,” he said. “I had to tell him, ‘Yes, you could die from this.’

“He’s come through a really, really challenging time at such an early age. It’s something most of us don’t have to do,” Moore said.

Mark Edmondson lives with lingering pain and scars left by surgery and radiation. At home Monday, he wasn’t shy about showing what it took to fight the disease.

The tumor removed two years ago was behind a molar. He opened his mouth to show that he’s missing teeth on the left side of his lower jaw. The bone there is so thin he isn’t allowed to play contact sports. Incisions went through his lip and chin, behind his ear and down his neck. He also lost much of the skin inside one side of his mouth.

Replacement skin, along with a vein and artery, was grafted from the inside of a forearm, where he has a large oval scar. To repair his arm, skin was taken from his thigh. Remarkably, his voice is normal and strong.

“People are staring at him constantly,” Berdahl said. The burning of radiation made the neck scar very visible, she said.

Mark takes the stares in stride. “I’ve said I’ve been attacked by a bear, a shark, everything,” he said.

Life now is so much more than being a cancer survivor. His grandmother helped him buy an old Ford Thunderbird. He keeps an eye on his brother, a freshman at Everett High.

The medical bills are staggering. Stephanie Edmondson has health insurance through her job at Fred Meyer in Lynnwood. There’s a $1 million insurance cap, and Mark said $750,000 has been used. “Every radiation treatment was $12,000, and I had it five days a week for six months. I’m in medical debt,” he said.

The bills don’t prevent him from looking ahead, perhaps toward a career in nutrition or physical therapy.

At Immaculate Conception/Our Lady of Perpetual Help School, where Mark went to grade school, fifth-grade teacher Karen Lovick remembers him as a favorite pupil. “What a good kid,” she said. “You have kids who kind of stand out in your class, and he stood out.”

When her husband, Sheriff John Lovick, was a state representative, Mark Edmondson served as page in the Legislature. “He’s a good leader,” Karen Lovick said. “When he had cancer he would come to visit me, just to say hi and give me a hug. I love him.”

Lovick said he once told her, “Whatever’s going to happen is going to happen. From a 17-year-old, that is so profound,” she said.

Stephanie Edmondson can’t breathe a complete sigh of relief. “I’m lucky,” she said, “But he’s not cured, he’s in remission.”

Even at Thanksgiving, do you dare ask this mother about gratitude? I did.

“I am grateful,” she said, “for everything.”

November, 2008|Oral Cancer News|

New cases of cancer decline in the United States

Author: Roni Cryn Rabin

The incidence of new cancer cases has been falling in recent years in the United States, the first time such an extended decline has been documented, researchers reported Tuesday.

Cancer diagnosis rates decreased by an average of 0.8 percent each year from 1999 to 2005, the last year for which data are available, according to an annual report by the National Cancer Institute, the American Cancer Society and other scientific organizations.

Death rates from cancer continued to decline as well, a trend that began some 15 years ago, the report also noted. It was published online in The Journal of the National Cancer Institute.

“Each year that you see these steady declines it gives you more confidence that we’re moving in the right direction,” said Dr. John E. Niederhuber, director of the National Cancer Institute, who is not an author of the report. “This is not just a blip on the screen.”

Death rates from cancer fell an average of 1.8 percent each year from 2002 to 2005, according to the new report. Although last year’s report said death rates dropped an average of 2.1 percent each year from 2002 to 2004, a modest 1 percent decline in 2005 lowered the average percentage for the period.

The decline is primarily due to a reduction in death rates from certain common cancers, including prostate cancer and lung cancer in men, breast cancer in women and colorectal cancer in both sexes.

The report attributes the reductions to adoption of healthier lifestyles and improved screening, as well as advances in treatment.

The drop in annual incidence rates is harder to interpret. The data may point to a real decline in the occurrence of some types of cancer, experts said. Alternatively, the decline may reflect inconsistent screening practices, causing some cancers that used to be detected to now go undiagnosed.

Breast cancer incidence rates decreased by 2.2 percent annually from 1999 to 2005, for example, a drop some researchers attributed to large numbers of women quitting hormone replacement therapy after a national study linked it to breast cancer in 2002.

Yet mammography rates have also fluctuated in recent years, meaning that some breast cancer cases may be going undetected, said Ahmedin Jemal, the strategic director for cancer surveillance at the American Cancer Society.

The incidence of prostate cancer declined by 4.4 percent a year from 2001 to 2005, after annual increases of 2.1 percent a year for several years, Dr. Jemal said. Yet prostate screening rates, too, have leveled off in recent years.

“This might not be good news,” Dr. Jemal said. “It’s always difficult to interpret the incidence rate.”

Christine Eheman, chief of the cancer surveillance branch at the federal Centers for Disease Control and Prevention, was more optimistic about the decline in cancer diagnoses.

“I do think it’s a good sign,” Dr. Eheman said, “but I think we need to be very careful not to think we have this problem in any way beaten. We need to continue to do what we know works, and also find out why some cancers are not decreasing and not decreasing in certain populations.”

Some types of cancer are being found more often, the report said. Among men, incidence rates increased for cancers of the liver, kidney and esophagus, and for melanoma and myeloma. Among women, incidence rates increased for cancers of the lung, thyroid, pancreas, brain and nervous system, bladder and kidney, and for melanoma. Rates of leukemia and non-Hodgkin’s lymphoma increased in both sexes.

The incidence of lung cancer has been declining among men for many years but rising among women, though the increase is slowing, according to the report.

“Women, unfortunately, got hooked on the smoking habit in the ’60s and ’70s,” Dr. Eheman said, “so there was a larger increase in smoking later on in time, and the prevention of smoking has been slower. The decrease in lung cancer that we hope will occur has not been happening yet.”

The report found sharp regional differences in lung cancer rates that appeared to be associated with local legislation, like smoking bans, and social attitudes toward tobacco and smoking. Lung cancer is diagnosed least often in Utah and most often in Kentucky, the report said.

State tobacco control policies appear to have had an enormous impact, the researchers said. In California, the first state to establish a comprehensive statewide tobacco control program, lung cancer death rates among men dropped by 2.8 percent annually on average from 1996 to 2005, twice the decline observed in many Southern and Midwestern states. California was the only state where the incidence of lung cancer among women had decreased.

Lung cancer death rates among women increased in 13 states: Alabama, Arkansas, the Carolinas, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Mississippi, South Dakota and Tennessee. Tobacco taxes are lower than average in many of these states, the report noted.

November, 2008|Oral Cancer News|

ASCO updates guideline on chemotherapy and radiation protectants

Author: Nick Mulcahy

In its first issuance since 2002, the American Society of Clinical Oncology (ASCO) has released an updated guideline on the use of protectants for chemotherapy and radiation therapy. The update provides new guidance on the use of palifermin, the only new protectant approved by the US Food and Drug Administration since 2002, as well as new or deleted recommendations for amifostine and dexrazoxane.

The updated guideline, published online November 17 in the Journal of Clinical Oncology, also addresses the concern that protectant agents could compromise tumor response and survival.

Palifermin, a recombinant keratinocyte growth factor, was approved for prophylaxis against severe mucositis associated with hematopoietic stem-cell transplantation in hematologic malignancies. It represents “an advance for the field,” write the guideline authors, cochaired by Martee L Hensley, MD, from Memorial Sloan-Kettering Cancer Center, in New York City, and Lynn M. Schuchter, MD, from the University of Pennsylvania, in Philadelphia.

Because of the growing body of evidence on amifostine use in the prevention of esophagitis, the ASCO panel of experts decided to add a new section on this topic in the chemoradiotherapy setting for non–small-cell lung cancer. Updates on amifostine also include guidance on its use for both chemotherapy and radiation-therapy toxicities.

With regard to dexrazoxane, the panel made only 1 change from the previous guidelines: guidance on its use in patients receiving high-dose anthracycline therapy has been deleted because of insufficient data. However, the panel highlighted its previous and ongoing recommendation that this agent not be used routinely in either the adjuvant or metastatic settings with initial doxorubicin-based chemotherapy.

The literature review on which the guidelines are based identified 744 potential randomized controlled trials. In the end, only 39 reports met the inclusion criteria and underwent data extraction. The majority of the reports (33) were for amifostine.

Using Palifermin to Prevent Oral Mucositis
According to the guideline, palifermin “is recommended to decrease severe mucositis in autologous stem-cell transplantation for hematologic malignancies with total-body irradiation-conditioning regimens.” The guideline recommends that clinicians “consider” the drug for patients undergoing myeloablative allogeneic stem-cell transplantation with total-body irradiation-conditioning regimens. However, the guideline stops short of recommending prophylactic use of this agent in the non–stem-cell transplantation setting because of insufficient evidence.

Mucositis is a new topic for the guideline. Considered by patients to be the worst complication of stem-cell transplantation, oral mucositis is characterized by mouth and oropharyngeal pain and impaired swallowing.

Oral mucositis is a frequent complication of both high-dose chemotherapy and radiation therapy, notes the guideline. In its least severe form, related mucosal erythema and ulceration are associated with few or no symptoms. However, oral mucositis can be severe enough to cause significant mucosal bleeding or tissue inflammation and edema that requires endotracheal intubation to protect a compromised airway. Palliation of pain generally requires intravenous narcotics.

An Array of Considerations Regarding Amifostine
As the protectant agent with the most studies reviewed by the panel, amifostine understandably has the most updates in the new guideline.

Amifostine can be considered for prevention of cisplatin-associated nephrotoxicity, reduction of grade 3 or 4 neutropenia, and to decrease acute and late xerostomia with fractionated radiation therapy alone for head and neck cancer, according to the guideline. However, with regard to reducing neutropenia, the authors note that clinicians can “reasonably” consider alternatives, such as using myeloid growth factor or reducing chemotherapy dose.

Furthermore, the panel does not recommend amifostine — either because of insufficient evidence or because of negative results — for “protection against thrombocytopenia, prevention of platinum-associated neurotoxicity or ototoxicity or paclitaxel-associated neuropathy, prevention of radiation-therapy–associated mucositis in head and neck cancer, or prevention of esophagitis during concurrent chemoradiotherapy for non–small-cell lung cancer.”

Recommendations on Dexrazoxane Largely Unchanged
Although continuing its previous recommendation that dexrazoxane not be used routinely in either the adjuvant or metastatic settings with initial doxorubicin-based chemotherapy, the panel suggests that clinicians consider “use with metastatic breast cancer and other malignancies for patients who have received more than 300 mg/m2 doxorubicin who may benefit from continued doxorubicin-containing therapy.” Because of the risk for cardiac toxicity with this agent, cardiac monitoring should continue in patients receiving doxorubicin.

The panel made no changes with regard to dexrazoxane, other than to delete a previous statement about potential use in patients receiving high-dose anthracyclines; with no new data on this topic, the panel said its clinical relevance appears limited.

Protectants Do Not Increase or Decrease Survival
The ASCO panel notes in the updated guideline that there is a “concern” that “chemotherapy and radiation therapy protectant agents may compromise tumor response and survival.”

However, their literature review provides no such evidence. “In all of the studies reviewed, for those studies reporting overall survival, disease-free survival, progression-free survival, or local control rate, no significant differences were found between patients receiving these agents and those not receiving them,” write the panel.

Nonetheless, there was a trend toward “higher objective response rates among patients with metastatic breast cancer initiating anthracycline treatment, compared with those assigned to anthracycline plus dexrazoxane,” they note. “Such a trend toward higher response rates was not observed among patients in studies where dexrazoxane treatment was delayed until after cumulative doxorubicin doses of 300 mg/m2,” they add.

According to the panel, patients should understand that protective agents have not been shown to increase or decrease disease-free or overall survival.

J Clin Oncol,  Published online November 17, 2008.

The panel members and authors have disclosed the following relevant financial relationships to the subjects under consideration. Consultant or advisory roles: Tarun Kewalramani, Amgen; Neal J. Meropol, Amgen; J. Tate Thigpen, Bristol-Myers Squibb; Andy Trotti III, GlaxoSmithKline, Viventia. Stock ownership: J. Tate Thigpen, Medimmunie; Andy Trotti III, Amgen.

Clinical Context
ASCO first published evidence-based guidelines for the use of protectants for chemotherapy and radiation therapy in 1999, and the last update was provided in 2002. Since then, a new protectant, palifermin, was approved by the US Food and Drug Administration for mucositis associated with stem-cell transplantation in hematologic malignant tumors, and growing evidence has been available on amifostine for esophagitis in chemoradiation therapy for non–small-cell lung cancer.

Other agents considered in the 2008 guidelines are dexrazoxane and mesna.

This is a review of the updated recommendations and the evidence supporting them by an expert panel of clinicians, researchers, health service experts, and other experts who met once, communicated though teleconference and email, and used trials since 2002 to compile the guidelines.

Study Highlights
The investigators searched the databases Medline, preMedline, and the Cochrane Library as well as libraries of panel members. 744 potential randomized controlled trials were identified, of which 39 reports met inclusion criteria. 2 studies of palifermin, 2 studies of dexrazoxane, 31 studies of amifostine, and no trials of mesna since 2002 were used for the panel guidelines.

Overall, many trials failed to document allocation concealment, and the majority lacked a placebo group.
In addition, tools used for assessment of symptoms varied across studies.

All but 1 recommendation remained unchanged from 2002. The guideline pertaining to use in patients receiving high-dose anthracycline was deleted because of lack of data.

There was no change in recommendation not to use for patients with breast cancer receiving initial doxorubicin-based chemotherapy.

Use should be considered for patients with breast cancer who receive more than 300 mg/m² of doxorubicin in the metastatic setting and in the adjuvant setting being considered for chemotherapy.
The dosage and administration, monitoring strategy, and other recommendations remain unchanged.

There is no change in recommendations for the use of amifostine for nephrotoxicity and neutropenia.
Alternative strategies such as myeloid growth factor support or chemotherapy reduction may be considered to ameliorate neutropenia.

The 2008 ASCO panel recommends against using amifostine for protection against thrombocytopenia in patients receiving chemotherapy or radiation therapy and for the prevention of platinum-associated neurotoxicity or ototoxicity because of insufficient data.

Amifostine may be considered for decreasing the incidence of acute and late xerostomia in patients undergoing fractionated radiation therapy alone for head and neck cancer, but not for routine use in concurrent platinum-based chemoradiotherapy for head and neck cancer.
Data are insufficient to support use to prevent mucositis associated with radiation for head and neck cancer and to prevent esophagitis in patients receiving concurrent chemoradiotherapy for head and neck cancer.

Data are insufficient to support its use for preventing taxane-associated neuropathy. There is no change in dosage and administration since 2002. Common toxicities include acute hypotension, nausea, and fatigue.

Palifermin is recommended in patients undergoing autologous or myeloablative allogeneic stem-cell transplantation for hematologic malignant tumor with a total-body irradiation-conditioning regimen to reduce severe mucositis, but not for chemotherapy regimens alone. There are insufficient data to support use for non–stem-cell transplantation or for the treatment of solid tumors.

Palifermin should be administered intravenously at 60 μg/kg/day for 3 days preceding conditioning treatment and 60 μg/kg/day for 3 days beginning on the day of stem cell infusion. It should be administered within 24 hours of the initiation of the conditioning regimen.

There is no change in recommendations for use with standard or high-dose ifosfamide, administration by the oral route, use with cyclophosphamide, and surveillance in patients receiving these agents.
No new data from randomized clinical trials on mesna were identified since 2002 to warrant any change to the 2002 recommendations.

Pearls for Practice
The protectants covered in the 2002 ASCO guidelines are dexrazoxane, amifostine, and mesna; palifermin has been introduced since then. The 2008 ASCO recommendations cover palifermin dosage and administration and indications; other recommendations for protectants have been modified or deleted owing to insufficient evidence.

November, 2008|Oral Cancer News|

What to expect: HPV vaccine Gardasil for men

Author: written by Vaccind Rx Daily Staff

The four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® is also effective in men according to the primary analysis from a pivotal phase III clinical study. In previously uninfected men aged 16 to 26 years*, Gardasil® prevented 90% (95%CI: 69, 98) of external genital lesions caused by HPV types 6, 11, 16 or 18. The data were presented this week at the congress of the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) in Nice, France.1

The study was designed to determine the efficacy of Gardasil® in preventing HPV 6,11,16 or 18- related ‘external genital lesions’ a composite endpoint that included genital warts, penile / perineal / perianal lesions† (PIN, PIN2/3; potential pre-cursors to cancer) and penile / perineal / perianal cancer.

In the study, Gardasil was 90.4% effective in reducing external genital lesions (3 cases in the vaccine group vs 31 cases in the placebo group; 95% CI:69.2, 98.1). All three cases observed in the HPV vaccinated group were of genital warts, resulting in a vaccine efficacy of 89.4% (95% CI [65.5, 97.9]) in preventing genital warts in men.

There were no cases of penile / perineal / perianal lesions in the vaccinated group vs. 3 cases in the placebo group. There were no cases of penile / perineal / perianal cancer in either group. At the time of this analysis, the study had a mean duration of about 29 months.

No HPV vaccine-related serious adverse events were reported. A slightly higher proportion of study participants reported injection-site adverse events in the vaccine group compared to the placebo group (60.1 % vs. 53.7 %).

The primary analysis was predetermined in the study protocol to be conducted after at least 32 cases of external genital lesions were observed. The study is still ongoing, and additional data will become available in the future.

“Although rarer than those in women, HPV-related genital cancers in men are serious diseases worth preventing; genital warts are as frequent in men as in women. In addition, men can transmit HPV to women who can develop cervical, vulvar and vaginal pre-cancer or cancer, and genital warts”, says Dr Nicholas Kitchin, Medical Director of Sanofi Pasteur MSD. “Based on these first encouraging results and future data we will have to define, together with the competent authorities and experts, how to approach a possible HPV vaccination of men in the future. Until this is done, vaccinating girls and young women remains the priority.”

Gardasil® is currently indicated for use in 9- to 15-year old girls and boys and 16 to 26-year old women for the prevention of cervical cancer, cervical, vulvar and vaginal pre-cancers and external genital warts caused by HPV types 6, 11, 16 and 18.

Current experience with the four-type HPV vaccine
Thirty years after the discovery that human papillomavirus (HPV) can cause cervical cancer, 15 years after the start of vaccine development and two years after the approval of the four-type (6,11,16,18) HPV vaccine Gardasil®, vaccination to prevent cervical cancer and other HPV-related diseases has been widely implemented.

Details about the new study results
In this randomized, double-blind, placebo-controlled trial, 4,065 young men aged 16-26 were administered quadrivalent HPV vaccine or placebo at enrolment, month 2, and month 6. Participants were not infected with one or more of the four vaccine HPV types 6, 11, 16 or 18 through one month post dose three and were randomised in a 1:1 ratio to receive three doses of either quadrivalent HPV vaccine or placebo at day one, two months and six months, with 36 months of planned follow-up from day one. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners. 1,397 men in the vaccine group and 1,408 men in the placebo who had received all three doses of either quadrivalent HPV vaccine or placebo were included in the analysis.

Indication of Gardasil®
Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil® in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

* who were not infected with one or more of the four vaccine HPV types at enrolment and one month after complete vaccination † PIN = penile/perineal/perianal intraepithelial neoplasia. Penile/perineal/perianal is defined as related to or affecting the penis (penile), the area between the anus and the scrotum (perineal), or the opening of the rectum to the outside of the body (perianal).

November, 2008|Oral Cancer News|

Health officials not convinced snus will help smokers quit

Author: staff

They’re discreet, flavorful and come in cute tin boxes with names like ”frost” and ”spice.” And the folks who created Joe Camel are hoping Camel Snus will become a hit with tobacco lovers tired of being forced outside for a smoke.

But convincing health officials and smokers like Ethan Flint that they’re worth a try may take some work.

Snus – Swedish for tobacco, rhymes with ”noose” – is a tiny, tea bag-like pouch of steam-pasteurized, smokeless tobacco to tuck between the cheek and gum. Aromatic to the user and undetectable to anyone else, it promises a hit of nicotine without the messy spitting associated with chewing tobacco. Just swallow the juice.

”I think I’d rather throw up in my mouth,” says Flint, an 18-year-old West Virginia University student, emerging from a convenience store with a pack of Winstons and a coupon for free Camel Snus. ”I’d rather not swallow anything like that.”

Reynolds America Inc., the nation’s No. 2 tobacco company, can also expect resistance from the public health community. Experts wonder whether snus will help wean people off cigarettes and snuff, or just foster a second addiction. While snus has been around, it hasn’t been prominent in this country.

”I think we’re all holding our breath in terms of what’s going to be coming down the pike,” says Dorothy Hatsukami, director of the Tobacco Use Research Center at the University of Minnesota. ”There’s not much known about these products – what’s in these products, how they’re going to be used, who’s going to be using them and what the effects of that use will be. … Will it create more harm or less harm?”

Reynolds is confident its new product will find a following. It launched Camel Snus in Austin, Texas, and Portland, Ore., in 2006, and has since expanded to test markets nationwide, with customers in nearly every state. Early next year, it’s taking snus national with a marketing blitz that spokesman David Howard says will include direct mail, print and Web advertising, and point-of-sale promotions.

Popular for decades in Sweden, where it was invented, snus has been banned in every other European Union nation since 2004 over concerns about carcinogens.

But smokeless tobacco is legal in the U.S., where there are two schools of thought: Some researchers suggest the lower risk of lung cancer makes snus an attractive alternative to smoking, while others fear an increase in problems including mouth lesions or pancreatic cancer.

The American Cancer Society supports any tool that helps smokers quit. ”But we don’t have any good scientific evidence that snus is one of those tools,” said Tom Glynn, director of cancer science and trends.

”If all smokers switched to snus tomorrow, in a few years we’d certainly see less heart disease, less lung disease and fewer cancers,” he said. ”But there’s no evidence that smokers can switch and stay switched.”

Prevention officials already have their work cut out for them in West Virginia, which has the third-highest adult smoking rate in the U.S. at nearly 27 percent and the highest rate of ”spit” or chewing tobacco use at 16 percent.

”The industry is brilliant, and whatever they want to outspend us by – $1 million, $10 million, $100 million – they can do it,” said Bruce Adkins of the state Division of Tobacco Prevention.

To sustain its current level of sales and combat tobacco-related deaths, Adkins says, the industry must find 4,000 ”replacement smokers” a year in West Virginia alone.

U.S. tobacco companies developed snus in response to both declining cigarette sales and consumer demand. With more public bans on puffing, they say smokers need socially acceptable alternatives.

Danny Wolfe, a 38-year-old computer draftsman, gave up regular spit tobacco and has been using Copenhagen tobacco pouches for several years. He spits out the juice; it gives him heartburn.

”It’s the same product, just packaged differently. It doesn’t get in your teeth. It doesn’t have the mess,” says Wolfe, who was sick of smoking outside his Morgantown office. ”You’re not quitting anything. You’re replacing.”

Snus is also popular with hunters, who try to avoid scent detection by their prey, and with coal miners, who work in underground mines where the smallest spark can trigger an explosion.

”I find that more rednecks use it,” Wolfe says. ”I won’t lie to you about that.”

At least two tobacco companies besides Reynolds are also test-marketing snus.

”There’s no secondhand smoke. There’s no spitting. We see it as a win-win,” says Howard, the Reynolds spokesman. ”It’s also in line with company strategy. We’re moving toward becoming a total tobacco company.”

Reynolds is even developing dissolvable tobacco strips, orbs and sticks that it will start test-marketing early next year in Portland, Indianapolis and Columbus, Ohio.

Though ”very appealing” in form and flavor, Hatsukami also finds those products worrisome.

Researchers have little information about nicotine absorption and toxicity for any of the new products, she says, and there’s too little data on snus to make per-dose comparisons to cigarettes or spit tobacco.

Still, Camel Snus recently tested by WVU contained at least two carcinogens.

”It’s not like chewing gum,” warns Robert Anderson, deputy director of West Virginia University’s Prevention Research Center. ”This product is not a safe alternative to cigarettes.”

And because its use is easy to conceal, WVU researcher Cindy Tworek worries children could suck on the pouches in front of oblivious parents or teachers. The brightly colored tins seem designed to attract both female and young users, she says.

The same age restrictions that apply to other forms of tobacco also apply to sales of snus, although they vary from state to state.

November, 2008|Oral Cancer News|

Reynolds American to sell dissolvable tobacco

Author: Vinnee Tong

Reynolds American gave details to investors Monday about its latest smokeless tobacco products, saying that it would begin selling Camel brand dissolvable tobacco products in mid- to late January in three trial markets.

The nation’s second-biggest tobacco company said that dissolvable strips, orbs and sticks — made from finely milled tobacco — will be sold early next year, starting in Columbus, Ohio; Indianapolis; and Portland, Ore.

They come in fresh and mellow flavors. Among their biggest selling points for smokers, who have fewer and fewer places to light up, is that there is no spitting and nothing left to throw away.

Cigarette companies are trying to find new ways of selling tobacco as cigarette demand has fallen because of smoking bans, health concerns and social pressure. They are focusing more on cigars and smokeless products such as moist snuff, chewing tobacco and snus.

Anti-tobacco groups objected last month when Reynolds first said it would begin selling dissolvable tobacco.

“These new products pose serious threats to the nation’s health,” a statement from the Campaign for Tobacco-Free Kids said then. “They are likely to appeal to children because they are flavored and packaged like candy, are easy to conceal even in a classroom and carry the Camel brand that is already so popular with underage smokers.”

Reynolds, which sells Camel, Kool and American Spirit cigarettes, defended the new dissolvable tobacco in part by saying the products come in child-resistant packs.

The company’s dissolvable tobacco products come in three shapes. Orbs are pellets that last about 15 minutes; strips last five minutes or less; and sticks, which are shaped like a toothpick but slightly bigger, last about 15 to 20 minutes. They are likely to cost less than cigarettes, spokesman David Howard said.

“We’re very excited about the potential of these modern smoke-free products,” Brice O’Brien, a senior vice president of growth and innovation, told investors at a conference on Monday.

O’Brien said it was too early to tell if dissolvable tobacco would prove to be a breakthrough innovation, like menthol or filtered cigarettes. But he said focus group testing on adult smokers showed greater interest for dissolvable tobacco than for snus.

Snus is teabag-like pouches that users stick between the cheek and gum. Reynolds, which first started selling snus in April 2006, plans to launch Camel Snus nationwide, also in the first quarter.

Reynolds American’s bigger rival, Altria Group-owned Philip Morris USA, is pursuing sales of smokeless products just as aggressively. Altria bought John Middleton Inc., the maker of Black & Mild cigars, in December 2007. Its pending acquisition of UST Inc., the U.S. market leader in smokeless tobacco, is expected to close during the first week in January. UST sells Skoal and Copenhagen products.

Winston-Salem, N.C.-based Reynolds has owned the Conwood smokeless tobacco business since May 2006. It sells moist snuff under the Grizzly brand.

November, 2008|Oral Cancer News|

Cost of smoking still staggering

Author: Lora Hines

The number of smokers nationwide dropped last year, but the amount of money they rack up in health care and financial losses is on the rise, according to federal health officials. In 2007, more than 43 million people smoked, compared to an estimated 45 million smokers in 2006, according to the Centers for Disease Control and Prevention.

Despite the decrease, average annual smoking-related costs reached nearly $100 billion between 2001 and 2004, compared to $75 billion in 1998, the agency found. Smoking’s total annual economic burden comes close to $195 billion, which includes lost productivity.

The CDC released the information as the American Cancer Society today marks its 32nd Great American Smokeout, the organization’s annual campaign to encourage people to quit smoking.

Tobacco use still is the single largest preventable cause of disease and premature death in the United States, according to the society. Smoking causes an estimated 438,000 people to die prematurely every year. That includes 38,000 deaths of nonsmokers because of secondhand smoke. Half of all people who keep smoking will die from smoking-related diseases, the organization says.

“Quitting smoking is the most important step smokers can take to improve their health and protect the health of nonsmoking family members,” said Janet Collins, director of the CDC’s National Center for Chronic Disease Prevention and Health Promotion.

State Program Praised

Meanwhile, UC San Francisco researchers earlier this year concluded that the California Tobacco Control Program saved the state $86 billion in health-care costs between 1998 and 2004. The program, which originated in 1989 and is funded by tobacco product taxes, was created to reduce smoking and improve people’s health. Researchers determined that the state saved the money because the program stopped people from smoking more than 3.5 billion packs of cigarettes.

Consuela Edmond, program director at the Riverside County Department of Public Health, said smoking-cessation programs and laws regulating tobacco sales to children and secondhand smoke exposure, might be helping to reduce smoking rates.

Information collected by the California Cancer Registry shows that tobacco-related cancers continued to decline between 1988 and 2005 statewide. But 14 percent of adult Californians still smoked in 2007.

Cancer is the second-leading cause of death in the state, and smoking is one of the key factors for cancer and other diseases, including heart and lung disease and diabetes, according to the registry. Every year, a third of the state’s estimated 50,000 cancer deaths are smoking-related, including 10,000 attributed to lung cancer.

Dr. Steven Kim, medical oncologist at Arrowhead Regional Medical Center in Colton, said most people associate smoking with lung cancer. But it also causes others, including in the head and neck, stomach, bladder and pancreas, he said.

By the time some cancers, especially lung cancer, are diagnosed, it’s too late, Kim said. Patients often don’t feel sick until the disease is in advanced stages.

“We can maybe improve survival rates,” he said. “But a cure is really unrealistic. It’s a very tough disease. It’s one of the worst diseases to have.”

Adding Up Costs

Costs associated with the disease can include doctor appointments, chemotherapy, radiation, tests and screenings and medicines, which have gotten better, but more expensive, Kim said. Some medicines can cost several thousand dollars per dose, he said, adding that a particular lung cancer drug costs $4,000 per month. Even with insurance, patients have to pay a share of the cost, Kim said.

“Cancer doesn’t just affect the patient. It affects the family,” he said. “Families could lose potentially two incomes because of caregiving needs and doctor’s appointments. A family really goes through their savings.”

Dr. Mohammad Aslam, a cardiologist at Arrowhead Regional Medical Center, treats smoking-related conditions, including heart attacks and strokes, which also are costly for patients and taxpayers. The medical center is the county hospital, which treats residents regardless of income.

“The direct and indirect costs can reach into several billions of dollars,” Aslam said.

A smoker’s health immediately begins to improve after quitting, he said. But Aslam warned that smoking is so destructive that it still can take someone’s body many years to heal.

“It takes 15 years to reach the point where they have similar risk of disease as someone who has never smoked,” he said.

November, 2008|Oral Cancer News|

Battle of his life

Author: Patrick Magee

Barney Farrar has never been one to back down from any type of fight.

The Mississippi native is a determined man whose tenacity makes him a passionate coach and dogged recruiter as a member of the Southern Miss football team’s coaching staff.

He’s also known as a compassionate man who will make a visit on his own to the ailing parents of one of the countless high school coaches he’s gotten to know over his lengthy career of recruiting his home state.

So when word came down in July that Farrar had been diagnosed with throat cancer, the reaction sent waves around the close community of football coaches. He received many calls from coaching cohorts wishing him well.

Once the kind words were behind him, Farrar battened down for the biggest battle of his life, which has yet to reach a full conclusion.

“They diagnosed it as a category three, but they moved it up to a category four because of the size of the tumor. That scared me,” Farrar said. “They told me to not be too alarmed over that at that point because it was just the size that moved me into the worst category.”

From there, it was a matter of finding the right course of treatment for the lump in his throat that doctors say had likely been there for a year, when he was living in Iowa, before it was diagnosed by Hattiesburg physicians.

Farrar, 48, visited different clinics around the South before he made a trek to Little Rock, Ark., to visit Dr. Amarjit Sen.

“I found out about Dr. Sen in Little Rock and I felt like the Lord drew my heart to that, and what a great one he was,” Farrar said. “He was like walking in a huddle with Brett Favre. When that guy looked in my eyes, he said ‘Coach, we’re going to get you well.’ When he said that, I said ‘Yeah, we’re going to get well.’

“It was like Brett Favre saying ‘Hey, I’m taking you to the end zone. We’re going to score and we’re going to win this championship. That’s what you want to hear.”

After debating over which course of treatment to go through, Farrar settled on a plan that required him to go through 62 radiation treatments and chemotherapy over a course of seven weeks. He had a port placed in his chest where the chemotherapy could be directed to his body via a tube. Farrar had his chemotherapy treatments every Monday for a length of six hours and had radiation treatments twice a day.

Side effects

Even though he has likely finished all of his radiation and chemotherapy, the implant remains in his side and a feeding tube is still connected directly to his stomach through his abdominal wall.

“It’s just cumbersome and bothersome,” Farrar said as he lifted his shirt to show his feeding tube. “In the first two or three weeks, that hurt me more than the radiation or any of the treatments.

“I don’t think people understand all the side effects. The cancer is cancer, but the side effects from the treatment are the things that hurt you.”

Farrar has been diligent about keeping his weight up, and he’s managed to lose no more than 11 pounds throughout his regimen.

Southern Miss sophomore tight end Jonathan Massey has noticed how the feeding tube can be an annoyance to his coach.

“Every now and then he’ll adjust it or something during a meeting,” Massey said. “He does the things he has to do. It doesn’t shock us. It’s not really making a scene; we just continue on with the meeting.”

One of the minor side effects that bothered Farrar the most was the fact that the treatment prevented him from producing saliva, even though that ability is slowly returning.

“I told him, ‘You’ve got to understand when you’re going through this not to worry about that,'” said Bobby Dews, a long-time Southern Miss booster and also a one-time oral cancer patient. “You’ve got to eat to live, not live to eat. It will come back soon, but the very least of your problems is your taste.”

Dews became close to Farrar as he went through his torturous regimen. He also got to know current Samford coach and former Heisman Trophy winner Pat Sullivan, who also once suffered from oral cancer.

“Bobby has been my best friend because he knows the pain I’ve felt,” Farrar said. “He knows the questions that I have in mind, and sometimes he would call and answer my question before I called and asked him. I didn’t even have to call.”

The toughest part of the treatment came in the final stages for Farrar.

“They gave me a heavy induction of the chemotherapy three weeks after I completed the 62 radiation treatments, and it will knock you to your knees if you weren’t prepared in your mind,” Farrar said. “They were making me feel good about myself and telling me I’d done better than most that go through it. When I went through the chemo I was probably feeling too good about myself because two days later, I was probably weaker than I’d ever been since I started treatment.

“I probably felt weird that UAB week because I was in the middle of it, but before the UCF game I had a spell before the game that wasn’t good. (USM head trainer) Todd (McCall) got me to the sidelines and gave me this cold towel and juiced me up (with an IV) and I was good to go.”

Always there

The part that is most amazing about how Farrar handled his treatment is that he was never far from sight at USM practices and he was constantly going over film and doing what he could to help the coaching staff recruit the state he knows so well.

“I don’t think I missed a practice actually,” said Farrar, who can be seen striding the sidelines during games. “I might have missed parts of practice because of being in treatment and I’d get there a little late. There were some days where it was hard to be there, but I’d rather be there than laying down.”

USM head coach Larry Fedora, who Farrar credits a great deal for helping him through the process, often found himself trying to make sure his tight ends coach didn’t overdo it.

“Constantly, I’d say ‘Go home and get some rest,'” Fedora said. “But he takes that as a challenge. So he doesn’t do it and I worry about him constantly. There were times I had to challenge him because he was down and he was tired and I could see it. Some people you couldn’t do that with, but Barney needed that. That’s what gets him out of bed every morning.

“He has been an inspiration to every one of our players and our staff.”

Farrar’s cancer treatment put the Golden Eagles’ five-game losing streak into perspective for the players, and the coach has thoroughly enjoyed watching his team rebound and sit one win away from bowl eligibility entering the final game of the regular season.

“To me, it’s like what I’ve been through,” Farrar said. “It’s a fight, but what are you going to do when things get tough? I found out what these guys are going to do when they get tough. They never changed. They never missed a beat and they stayed right in line with what they were doing and boom, it started clicking.”

Road ahead

Farrar has been encouraged with what doctors have told him in recent checkups as the tumor has visibly shrunk from its original size.

“With the naked eye, they looked in there and they feel like the tumor has completely shrunk,” Farrar said. “I still have a CT scan and PET scan to go through. They have to scan my blood work and, possibly, they’re going to try to do one more treatment just to make sure that’s stuff not in your body.”

Farrar’s faith has played a big part in maintaining his strong will throughout his treatment, and he’s confident that he’s surpassed yet another hurdle.

“I feel that God has blessed me throughout this and he has helped me understand who I am,” Farrar said. “I had a terrible car accident in 1983 that should have blinded me, should have given me brain damage. Long story short, he has brought me through another time in my life.

Farrar says he could possibly undergo one more chemotherapy treatment before he will have a CT scan late in December. He should know by the end of the year whether or not he has been given a clean bill of health.

“I could have been one of those 7,000 other (cancer patients) that die with it every year, but I didn’t,” Farrar said. “I’m still alive and healthy right now. I won’t know until the tests come through, but in my heart I know.”

November, 2008|Oral Cancer News|

Eli Lilly buys majority of ImClone in tender offer

Author: staff

Drug developer Eli Lilly & Co. said Friday it completed a tender offer worth about $6 billion for ImClone Systems Inc., marking Lilly’s biggest buyout in the biotechnology industry.

The company announced the $70-per-share tender offer in October. The bid topped two prior offers from Bristol-Myers Squibb Co., which is ImClone’s partner on the blockbuster drug Erbitux.

Indianapolis-based Eli Lilly bought about 85.4 million shares of New York-based ImClone, representing about 95 percent of the outstanding stock. The company plans to complete the buyout through a short-form merger on or about Nov. 24. in which all remaining shares of ImClone will be converted into the right to receive $70 per share in cash.

With the buyout, Indianapolis-based Eli Lilly adds the blockbuster colon and head and neck cancer drug Erbitux to its list of products. Eli Lilly, which sells a range of treatments from Byetta for diabetes to Cymbalta for depression, has been bulking up its biotechnology capabilities along with several other large pharmaceutical companies.

Eli Lilly already gets about a third of its annual revenue from biotechnology drugs, which are developed using living cells instead of chemical compounds. The company has already invested $1 billion into a biotech center in Indianapolis, while building a biotech facility in Ireland.

November, 2008|Oral Cancer News|