FDA

The FDA’s power over cigars

Source: www.latimes.com/health
Author: editorial

The 2009 federal law that required the U.S. Food and Drug Administrationto begin regulating cigarettes also gave it the option of regulating cigars. Now two bills, one in each chamber of Congress, would remove the agency’s authority over “traditional” cigars — the regular size that you’re used to, not the ones the size of cigarettes.

Customers of 2nd St. Cigars in Long Beach smoke cigars outside. According to the National Cancer Institute, cigars have higher levels of tar, toxins and carcinogens than cigarettes and cause cancers of the mouth, lips, throat and esophagus. (Los Angeles Times / June 5, 2012)

It’s true that cigarettes are the far bigger health scourge in the United States, accounting for nearly one in five deaths each year, according to the U.S. Centers for Disease Control and Prevention. Traditionally, cigars have not been popular among young people, which is significant because preventing smoking among youth is one of the key reasons for regulating tobacco.

But there’s nothing good to be said about the health effects of cigar smoking levitra de 20 mg xifaxan médicament. Even though cigar lovers don’t typically inhale the smoke, their lung cancer rates are higher than those of nonsmoking Americans — though lower than those of cigarette smokers. According to the National Cancer Institute, cigars have higher levels of tar, toxins and carcinogens than cigarettes and cause cancers of the mouth, lips, throat and esophagus. They also produce more secondhand smoke.

The rate of cigar smoking have been increasing for the last two decades, and cigars can now be found in fruit and candy flavors, including chocolate — the same kind of flavor tweaking that got many teenagers hooked on cigarettes. That was why the Family Smoking Prevention and Tobacco Control Act — the legislation that gave the FDA regulatory authority over tobacco products — banned flavoring in cigarettes. The new bills would prevent the FDA from doing the same for many types of cigars.

Last year, the state of Maryland found that while cigarette smoking was less popular among teenagers, cigar smoking had increased, a trend that state officials blamed on flavored cigars. Similar findings have been reported in other states over the last several years. True, those numbers include the very small cigars that would continue to be regulated by the FDA if the legislation passed, but they also include the larger ones. Many high school and college students mistakenly believe that cigars are not very dangerous.

It would be a shame to see the hard-fought battle against cigarettes undermined by increased cigar use. Whether in cigarettes, cigars or pipes, tobacco is a harmful product that kills and sickens many of the individuals who smoke it, and costs taxpayers enormous sums in treatment for smoking-related diseases. That’s why the FDA was given the power to regulate it, power that should not be weakened now.

The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine

Source: Forbes Magazine, written by Matthew Herper

Neal Fowler, 50, the chief executive officer of a tiny biotech called ­Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck.

Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it.

The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing.

His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors wanted to do a second surgery, opening up his neck, but by polling other experts he found a ­different team and a different option: chemo­therapy and radiation.

But it gnaws at Fowler, who thinks about vaccines all day long—Liquidia’s vaccine work made it the only startup to receive an equity investment from the Bill & Melinda Gates Foundation—that one that might prevent other boys, including his teenagers, from ever developing this cancer isn’t being used. Gardasil, one of two HPV vaccines, is already approved in boys to prevent anal and penile cancers, but because these diseases are rare, only 1% actually get it. And tests that might well prove that this Merck product can prevent the new throat cancer strain would take at least 20 years, until the boys sampled actually became sexually active and then contracted the disease.

“We’ve got this two- or three-decade window where more and more of these patients like myself are going to emerge,” says Fowler. “To me the ­[vaccine] risk is minimal, and I’d say, why not do that?”

 

The incidence of HPV throat cancer is rising

A big part of the answer is politics. Drug safety, vaccines, antibiotics and reproductive medicine—all have become proxies for the culture war, often tripping up public health in the process. Big Pharma hasn’t helped, with deep p.r. wounds that have made it anathema to both political parties. Nor has the FDA, which has shifted the goalposts on ­approving new antibiotics enough to scare away many innovators just as ­resistant bacteria have become a big health problem. Both parties undermined the FDA further by overruling it on how the Plan B emergency contraceptive should be used, weakening the agency’s authority. Now a coalition on the right is pushing to remove all testing of whether some medicines are ­effective, while many on the left still think the FDA ­remains too cozy with the drug industry.

“If you look at both sides of the political spectrum I’m amazed and appalled by the lack of knowledge that’s being put forward as knowledge,” says Robert Ruffolo, former head of research at Wyeth. “They’re not scientists, they’re not physicians, and many politicians will say almost anything during election season.”

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

April, 2012|Oral Cancer News|

Court: Tobacco Health Labels Constitutional

Source: Reuters.com

Combination picture of new graphic cigarette packages, released by the U.S. Food and Drug Administration June 21, 2011, shows a varied collection of a man on a ventilator, diseased lungs and dead bodies were among the graphic images for revamped U.S. tobacco labels, unveiled by health officials who hope the warnings will help smokers quit. REUTERS/U.S. Food and Drug Administration/Handout

Combination picture of new graphic cigarette packages, released by the U.S. Food and Drug Administration June 21, 2011, shows a varied collection of a man on a ventilator, diseased lungs and dead bodies were among the graphic images for revamped U.S. tobacco labels, unveiled by health officials who hope the warnings will help smokers quit.

Credit: Reuters/U.S. Food and Drug Administration/Handout

By Terry Baynes

(Reuters) – A U.S. law requiring large graphic health warnings on cigarette packaging and advertising does not violate the free speech rights of tobacco companies, a federal appeals court ruled on Monday.

Cigarette makers had sued to stop the U.S. Food and Drug Administration’s new labeling and advertising requirements on grounds the rules violated their First Amendment right to communicate with adult tobacco consumers.

But the Cincinnati-based U.S. Court of Appeals for the 6th Circuit upheld the bulk of the FDA’s new regulatory framework, including the requirement that tobacco companies include large warning images on cigarette packs.

The decision comes on the heels of a Washington, D.C., judge’s ruling in a different, but related, case that rejected the FDA requirements and seems to set up a clash over the constitutionality of the FDA rules.

Floyd Abrams, a lawyer for Lorillard, noted the difference in tone in the two rulings and said the 6th Circuit case, the Washington case, or both, would likely end up in the U.S. Supreme Court.

The difference in the two cases is that the FDA had not introduced the specific images when the companies filed the 6th Circuit suit. While the Washington suit focused on the images, the appeals court addressed the larger issue of the FDA’s regulatory power.

“There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products,” Judge Eric Clay wrote for the three-judge 6th Circuit panel.

Congress passed the law in 2009 and ordered the FDA to adopt specific warning-label regulations. The labels must be in color, must cover the top 50 percent of a cigarette pack’s front and back panels, and must cover the top 20 percent of print advertisements.

After tobacco companies, including R.J. Reynolds Tobacco Co and Lorillard Inc’s Lorillard Tobacco Co, sued to block the law, the FDA unveiled nine images to go on cigarette packs, including graphic pictures of dead bodies, diseased lungs and rotting teeth. The companies accused the government of forcing them to disseminate an anti-smoking message in order to stigmatize and embarrass already-informed consumers.

The appeals court panel’s two-judge majority disagreed with the companies on the label requirement, finding that the fact that the specific images might trigger disgust does not make the requirement unconstitutional. The majority did note that it was only addressing the constitutionality of the statute on its face, and not the specific images that the FDA introduced after the suit was filed.

DISSENT ON IMAGES

Judge Clay, who wrote the main opinion upholding most of the FDA regulations, dissented, however, on the graphic label ruling. He called the rule “simply unprecedented.” While the government can require a product manufacturer to provide truthful information, “it is less clearly permissible for the government to simply frighten consumers or to otherwise attempt to flagrantly manipulate the emotions of consumers as it seeks to do here,” Clay wrote.

On February 29, D.C. district judge Richard Leon ruled that the FDA’s images violated the tobacco companies’ free-speech rights. He found that the warning labels were too big and that the government has numerous other tools at its disposal to deter smoking, such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images.

The Obama administration appealed that ruling to the U.S. Court of Appeals for the District of Columbia Circuit on March 5.

Lorillard lawyer Abrams says Monday’s appeals court decision does not necessarily conflict with the Leon’s decision.

“The court made clear it was focusing on the statute as written, as opposed to the implementation of it,” Abrams said.

The Department of Justice did not immediately provide comment.

The 6th Circuit also upheld other FDA regulations, including restrictions on the marketing of “light” cigarettes, on the distribution of free tobacco samples, and event sponsorship. The court struck down a rule barring the use of color and graphics in tobacco advertising.

“We are pleased the 6th Circuit Court of Appeal upheld the continued use of colors and imagery in our advertisements,” said R.J. Reynolds spokesman Bryan Hatchell.

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

March, 2012|Oral Cancer News|

Judge Rules Graphic Cigarette Warning Labels Unconstitutional

 Source: Time Magazine- Healtland
FDA

The government’s effort to put graphic warning labels about the dangers of smoking on cigarette packs hit another legal snag on Wednesday.

A Washington judge declared unconstitutional a Food and Drug Administration (FDA) mandate that would force cigarette makers to use the labels, which include images of a corpse of a smoker, smoking-damaged teeth and gums and diseased lungs, saying that it violated cigarette makers’ freedom of speech under the First Amendment.

U.S. District Judge Richard Leon wrote in his ruling that the images “were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.”

SPECIAL: FDA Unveils Final Cigarette Warning Labels

That’s been the argument of cigarette makers, who say that the images go beyond merely informing the public to forcing the manufacturers to advertise the government’s anti-smoking agenda, with the purpose of convincing smokers to give up the habit.

Leon’s ruling fell in line with his previous decision in the case in November, when he issued a temporary injunction blocking the new labeling effort. That decision has already been appealed by the government.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA regulatory authority over tobacco products for the first time. Under that law, the FDA required cigarette makers to cover the top half of the front and back of cigarette packs with the graphic warning labels and to use the images in 20% of their advertising. The new labeling is to go into effect by Sept. 22, 2012, but five major tobacco companies have sued the government over the requirement for violating their freedom of speech.

SPECIAL: Cigarette Warning Labels From Around the World

Other members of the tobacco industry are suing over the original law granting the FDA authority to limit nicotine content in tobacco products and to restrict companies from marketing efforts such as sponsoring events and giving away free samples. That case is pending appeal.

In a statement issued after Judge Leon’s ruling, the Department of Health and Human Services said it was undeterred in its effort to bring stronger warnings to cigarette labels:

This Administration is determined to do everything we can to warn young people about the dangers of smoking, which remains the leading cause of preventable death in America. This public health initiative will be an effective tool in our efforts to stop teenagers from starting in the first place and taking up this deadly habit. We are confident that efforts to stop these important warnings from going forward will ultimately fail.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
March, 2012|Oral Cancer News|

HPV Vaccine Not Linked To Autoimmune Disorders, Study

Source: MedicalNewsToday.com

A two-year study of nearly 190,000 girls and women, finds that Gardasil, the human papillomavirus (HPV) vaccine made by Merck & Co, does not trigger autoimmune disorders such as lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The results are published in the Journal of Internal Medicine.

Study lead author Dr Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, California, said in a statement released on Friday, that:

“This kind of safety information may help parents with vaccination decisions.”

“”These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use,” said Chao.

Gardasil is a “quadrivalent” vaccine because it helps protect against 4 types of HPV. In girls and young women age 9 to 26, it targets 2 types that cause about 75% of cervical cancers, and 2 other types that cause 90% of cases of genital warts.

The vaccine, which is given as three injections over six months, also helps protect boys and men age 9 to 26 against 90% of cases of genital warts.

Genital warts is the most common sexually transmitted infection in the US, where it infects about 6.2 million people every year. It can also lead to cervical cancer in women.

Gardasil received US Food and Drug Administration (FDA) approval in 2006. But a longstanding concern about links with autoimmune disorders has surrounded the vaccine, and many parents won’t let their children be vaccinated because of this.

However, Chao and fellow co-investigators from Kaiser Permanente told the press “most speculated associations have stemmed from case reports that have not been confirmed by large, controlled epidemiologic studies”, and their investigation “presents findings from a well-designed, post-licensure safety study of the vaccine on a large, ethnically diverse population”.

For the study, Chao and colleagues used electronic health records of 189,629 girls and women age 9 to 26 years in California. The participants had been followed for six months after receiving each dose of the quadrivalent HPV vaccine in 2006-2008.

They found no increase in any of 16 autoimmune disorders in the vaccinated population compared to a matched population of non-vaccinated girls and women. The 16 autoimmune disorders they looked for were:

“… immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto’s disease, Graves’ disease, multiple sclerosis, acute disseminated encephalomyelitis, other demyelinating diseases of the central nervous system, vaccine-associated demyelination, Guillain-Barré syndrome, neuromyelitis optica, optic neuritis and uveitis.”

The researchers explained that the clinical trial data on the vaccine, and the subsequent adverse event reports, have important limitations when it comes to assessing its safety profile.

This is because clinical trials are often based on a highly selected group of participants, the sample sizes are too small, and the follow up is too short, to catch rare safety events such as autoimmune disorders.

And the adverse event reports are not easy to interpret because there is no comparison group, and it is hard to tell if the condition developed before or after the vaccine.

So in their study, Chao and colleagues used methods like in-depth reviews of medical charts to ensure accuracy of diagnosis and that the disease occurred after vaccination. Plus, disease incidence in the vaccinated group was contrasted with incidence in a comparable unvaccinated group.

The results showed that:

  • Overall, there were 1,014 new-onset cases of an autoimmune disorder, of which 719 were eligible for case review, and 31 (40%) were confirmed as new onset (ie emerged after vaccination).
  •  Of these cases, “no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition”.
  •  None of the estimated incidence rate ratios was signficantly raised, except that for Hashimoto’s disease (IRR = 1.29, 95% confidence interval: 1.08-1.56).
  • “Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions.”

The authors note that neither the investigators, nor an independent safety review committee, found any autoimmune safety concerns in the study.

The study appears to have been well received by experts not connected to the investigation.

Dr. Harry Fischer, chief of the division of rheumatology at Beth Israel Medical Center in New York City welcomed the findings and described the study as well-designed:

“This article speaks to the safety of the vaccine and helps to confirm that it does not contribute to the development of autoimmune diseases,” he said, in a report from USA Today.

Merck & Co funded the study.

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

February, 2012|Oral Cancer News|

Third Head and Neck Indication for Erbitux

Source: The ASCO Post, January 1, 2012, Volume 3, Issue 1, Matthew Stenger

 

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.Cetuximab (Erbitux) was recently approved by the FDA for use in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck.1-3 Cetuximab has prior indications in combination with radiation therapy in locally or regionally advanced squamous cell head and neck cancer and in recurrent or metastatic head and neck cancer that has progressed after platinum-based therapy. It also has indications in colorectal cancer.

3.1.17_chart.jpg

The most recent approval is based primarily on results of a study conducted outside the United States in 442 patients with metastatic or locally recurrent squamous cell carcinoma of the head and neck who were not suitable for curative treatment with surgery or radiation. The study used a European Union (EU)-approved cetuximab rather than the U.S.-approved cetuximab (Erbitux). Erbitux provides approximately 22% higher exposure than the EU-approved cetuximab; these pharmacokinetic data, together with the results of the study conducted in Europe and other data using Erbitux establish the safety and efficacy of Erbitux at the recommended dose.In this trial, the addition of cetuximab (n = 222) to platinum-based therapy plus 5-FU (n = 220) significantly increased median overall survival from 7.4 to 10.1 months, representing a 20% reduction in risk of death (HR = 0.80, P = .034), and significantly increased median progression-free survival from 3.3 to 5.5 months, representing a 43% reduction in risk of disease progression (HR = 0.57, P < .0001). Objective response rates were 35.6% in the cetuximab group and 19.5% in the chemotherapy-alone group (P = .0001).


3.1.17_ofnote-1.jpg

How It Works

Cetuximab is an IgG1 monoclonal antibody that inhibits ligand-binding to the epidermal growth factor receptor (EGFR) on both normal and tumor cells. Binding of cetuximab to EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased production of matrix metalloproteinase and vascular endothelial growth factor. In cells with activating KRAS mutation, however, the KRAS proteins are continuously active and are independent of EGFR regulation. Cetuximab also stimulates antibody-dependent cell-mediated cytotoxicity and enhances the activity of a number of chemotherapeutic agents, including cisplatin.

How It Is Given

For the new indication, the recommended dose is 400 mg/m2 as a 120-minute IV infusion, with a maximum rate of 10 mg/min, on the day that platinum-based therapy plus 5-FU is started. The infusion must be completed 1 hour prior to beginning platinum-based therapy plus 5-FU. The subsequent weekly dose is 250 mg/m2 over 60 minutes until disease progression or unacceptable toxicity.Patients should be premedicated with an H1 antagonist (eg, diphenhydramine, 50 mg) IV 30 to 60 minutes before the first dose of cetuximab; premedication for subsequent doses depends on clinical judgment and presence/severity of prior infusion reactions. The infusion rate should be reduced by 50% for grade 1 or 2 or nonserious grade 3 infusion reactions. Cetuximab should be immediately and permanently discontinued for severe infusion reactions.In cases of severe acneiform rash, administration should be delayed by 1 to 2 weeks, and cetuximab discontinued at the fourth occurrence. The weekly dose should be reduced to 200 mg/m2 after the second occurrence and 150 mg/m2 after the third.Cetuximab should be administered via infusion pump or syringe pump and through a low protein-binding 0.22-micrometer in-line filter.

Safety Profile

Cetuximab carries a boxed warning for infusion reactions and cardiopulmonary arrest. Serious infusion reactions occurred in approximately 3% of patients in clinical trials, with fatal outcome in less than 1 in 1,000 cases. In patients with squamous cell carcinoma of the head and neck receiving cetuximab, cardiopulmonary arrest or sudden death occurred in 2% of those receiving radiotherapy and in 3% of those receving platinum-based therapy plus 5-FU. Serum electrolytes, including magnesium, potassium, and calcium, must be carefully monitored during and after cetuximab administration.In the trial supporting the current indication, the most common adverse reactions (≥ 25%) in patients in the cetuximab group were nausea, anemia, vomiting, neutropenia, rash, asthenia, diarrhea, and anorexia; conjunctivitis occurred in 10%. Other adverse reactions, sometimes severe, caused by cetuximab included infusion reactions, hypomagnesemia, hypocalcemia, and hypokalemia. Death attributed to cardiovascular event or sudden death was reported in 3.2% of the patients in the cetuximab group and in 1.9% in the chemotherapy alone group.

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

January, 2012|Oral Cancer News|

UI professors: HPV editorial misses the mark

Source: The Daily Iowan

The Nov. 29 editorial “Recommend Pap smears, not vaccines, to prevent cervical cancer” completely missed the mark with regard to HPV vaccines. We are researchers and clinicians at the University of Iowa who study and treat HPV and other infectious diseases. It is disturbing to think that the article might dissuade individuals from getting a safe and effective vaccine that can prevent cancer.

First of all, it has been conclusively demonstrated that the vaccines are effective at preventing HPV infection. Cervical cancer is caused by HPV. Additionally, cancers of the head and neck are linked to HPV, including cancers in males. It has been clearly shown that the vaccines prevent the development of precursors to cervical cancer. In the editorial, Dr. Diane Harper was quoted as saying, “If doctors tell patients that this vaccination will prevent cancer, they’re telling them a lie.” This statement from Dr. Harper is simply misleading.

In the vaccine studies, non-treatment of precursor lesions in the placebo group in the context of a clinical trial was considered unethical, and therefore, any precursor lesions were treated. Subsequent development of cancer in the placebo group was prevented by the required ethical treatment. Thus, the trials could not evaluate prevention of advanced cancer, per se. Because it takes cervical cancer a long time to develop, it will take about 15 more years to have data on incidence rates of cervical cancer from a large vaccinated general population. Because the vaccines prevent HPV infection and HPV-associated precursor lesions, they will prevent cancer.

The statement that the vaccines offer only five to seven years of protection is also misleading. The vaccine trials were initiated only five to seven years ago, and while we know that protection has been good for that period of time, there is no evidence that protection is waning. Only time will tell if protection is longer-term but this should in no way deter individuals from getting vaccinated. The earlier vaccinated populations are being carefully followed and, over time, it will be known if booster vaccinations are required. It is known with some other vaccines, such as the diphtheria vaccine, day-to-day potential encounter with the causative microbe stimulates additional protection in a significant part of the previously vaccinated population, reducing the need for re-vaccination.

Both vaccination and Pap smears are two important tools to prevent cervical cancer. It is not a question of “either/or.” The editorial failed to mention that Dr. Harper advocates vaccination for both sexes in several of her published articles. However, Pap smears are still critical. The HPV vaccines do not cure HPV infections once they have occurred, and most women do not know whether they have been infected or not. In addition, the current vaccines only protect against two cancer-causing HPV types which account for more than 70 percent of cervical cancers. Other cancer-causing types exist, so vaccinated individuals should not feel a false sense of security. In other words, women need to continue to get Pap smears even if they have been vaccinated.

The side effects and safety concerns of the vaccine are also greatly misrepresented in the editorial. The article fails to mention that the CDC and FDA have been closely monitoring the safety of HPV vaccines and have deemed them safe. The statement that 73 percent of those who received the vaccine reported new medical conditions gives a wrong impression regarding safety. The editorial fails to mention that almost all (more than 90 percent) of the reported “medical conditions” were considered minor (e.g. pain and swelling at the site of injection), common events in all vaccination protocols. While severe reactions to the vaccine have been encountered, these could not be directly tied to the vaccine, no specific patterns were observed in these events, and those that were reported were consistent with events that occur in healthy adolescent and adult populations of similar size. It should be mentioned that there were slightly elevated risks of fainting and anaphylaxis that occurred within 15 minutes of vaccination, which led to the recommendation that those who are vaccinated be monitored for 15 minutes after vaccination. This is true of all vaccinations. The CDC continues to closely monitor the safety of the vaccines and makes recommendations based on the data.

It is too easy to think of HPV cancers as preventable by Pap smears alone. Furthermore, it is too easy to understate the importance of both vaccination and Pap smears. It needs to be emphasized that not all HPV-associated cancers can be detected by Pap smears. Consider this: A male developed HPV-associated head and neck cancer six months ago. This was discovered in the male during shaving, simply as a swollen neck lymph node. The downstream consequence of this finding was the male received radiation and chemotherapy for months that had to be stopped prematurely since the patient was near death because of treatment. Three months later, the male is still being fed by tubes, does not have a sense of taste, cannot speak clearly, has radiation burns on his face, and has significant anxiety because he remains susceptible to recurrence of cancer. His cancer is linked to one of the HPVs that is in the vaccine, and to think, this could have been prevented with vaccination prior to his initial infection with HPV. It is too late now for him to have vaccine protection.

In the summary of the editorial it is stated “not enough is known about HPV vaccinations to be recommended to the general population by medical professionals.” This statement is false. The CDC, which does not take these things lightly, has recommended vaccination for prevention of cervical cancer and also more recently for anal cancer. The recommendation was based on sound medical and scientific findings. The editorial did not follow these same principles.

This opintion piece was signed by five University of Iowa professors: Al Klingelhutz, Ph.D., Pat Schlievert, Ph.D., Stanley Perlman, M.D., Marty Stoltzfus, Ph.D., and Colleen Kennedy Stockdale M.D., M.S.

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

December, 2011|Oral Cancer News|

Use and Acceptance of HPV Vaccine Still a Work in Progress

Source: National Cancer Institute

A bellwether moment in the history of cancer prevention came in 2006 when the Food and Drug Administration (FDA) approved the first vaccine to prevent cervical cancer. The vaccine, Gardasil, protects against the two primary cancer-causing, or oncogenic, types of the human papillomavirus (HPV)—HPV-16 and HPV-18. These types are responsible for more than 70 percent of cervical cancer cases worldwide. In 2009, the FDA approved a second HPV vaccine, Cervarix, which also targets HPV-16 and HPV-18.

Gardasil and Cervarix, vaccines that protect against the two primary cancer-causing types of the human papillomavirus (HPV), entail a three-shot regimen, with each dose delivered several months apart.

But what has transpired since these two vaccines received regulatory blessing in the United States has reaffirmed something that cancer and public health researchers have appreciated for some time: The translation of basic research to the clinic doesn’t end with FDA approval of a new drug or treatment. In many respects, FDA approval is just a beginning.

In March 2007, the CDC’s Advisory Committee on Immunization Practices (ACIP) gave its strongest recommendation for HPV vaccination for females ages 9 to 26, which is the FDA-approved indication for Gardasil. Cervarix is approved for females ages 10 to 25. Both vaccines entail a three-shot regimen, with the doses delivered several months apart. According to the most recent data, only 44 percent of adolescent girls 13 to 17 years of age have received at least one dose of the vaccine. Completion rates for the three-shot regimen are substantially lower, with only 27 percent of adolescent girls receiving all three doses.

“Uptake is low because of problems with policy, problems with clinical encounters, and problems with parents’ decisions,” said Dr. Noel Brewer of the University of North Carolina Gillings School of Global Public Health. These obstacles are by no means insurmountable, but addressing each obstacle will take time, patience, and research, say investigators working in this area. And a good bit of that research can be grouped into two categories: missed opportunities and teachable moments.

HPV Vaccines for Boys

Gardasil has also been approved by the FDA for use in boys. The initial approval in boys, in 2009, was for the prevention of genital warts because Gardasil, unlike Cervarix, also protects against two other HPV types—HPV-6 and HPV-11—that are the primary cause of genital warts.

But, in December 2010, the approval was expanded to include the prevention of anal cancer, another disease associated with HPV-16 and HPV-18 infection. Because the approval for boys is so recent, this article focuses only on the uptake of the HPV vaccines by females.

No vaccine has an uptake rate of 100 percent, although when vaccines are mandated, such as those required for school attendance, vaccination rates can reach 80 to 90 percent. Although there has been a flurry of legislative activity at the state level since Gardasil was approved in 2006, only Virginia and Washington, DC, require HPV vaccination for school entry, and Virginia’s law includes a provision that allows parents to opt out of the requirement.

Based on surveys that Dr. Brewer and his colleagues have conducted, concerns that HPV vaccination will encourage sexual activity seem to have had little to do with the lagging vaccination rates. Nor, he continued, has uptake of the vaccines been substantially affected by the antivaccine movement that was spurred by fears raised about the now-discredited links between autism and childhood vaccines.

In general, concerns about safety and other issues with vaccines “are not specific to the HPV vaccine,” said Dr. Gregory Zimet of the Indiana University Melvin and Bren Simon Cancer Center. “There is a general vaccine hesitancy that affects a lot of parents.”

The Power of Physician Recommendations

Factors affecting vaccination rates have “definitely been a mixed bag,” agreed Veronica Chollette, who oversees a portfolio of HPV vaccine-related research in NCI’s Division of Cancer Control and Population Sciences. Cultural issues, lack of awareness, and, initially, reimbursement issues that limited the amount of vaccine physicians were willing to keep in stock have all played a role, she noted.

Physician encounters have also had an effect in an entirely different way. In a study published last year, less than 60 percent of pediatricians reported that they strongly recommended HPV vaccination for their 11- to 12-year-old patients. Another study of women ages 19 to 26 showed that, among women whose doctors did not recommend HPV vaccination, only 5 percent were vaccinated. Among those who did receive a recommendation, 85 percent were vaccinated.

“Pediatricians and family physicians are missing a lot of opportunities when patients come in for office visits,” said Dr. Brewer. Part of the problem, he added, is a systemic issue: health care providers are not flagging the charts of patients who are eligible for the vaccines or using reminder systems in electronic medical records, for example.

Interactions with the health care system drop precipitously once kids reach adolescence, he continued. “So it’s a big deal to miss those chances.”

Sociocultural factors are also important to consider. A study conducted in Appalachia, for example, found that conservative religious beliefs and a mistrust of outside influences played a prominent role in the vaccines’ acceptability. Meanwhile, studies of college-age women have shown that, even when receipt of the initial HPV vaccine dose was similar among white and black women, completion rates for all three doses were substantially lower among black women.

The disparity is noteworthy, Chollette stressed, because black women and Hispanic women have significantly higher cervical cancer incidence and death rates than white women.

In some cases insurance status can affect vaccine uptake and adherence. But, because federal and state-level programs, such as the Vaccines for Children program, make the vaccines available for free or for a minimal charge to low-income children, it may not contribute as much to the disparities in vaccination rates, said Dr. Ruth Carlos of the University of Michigan Medical Center. In fact, a higher percentage of 13- to 17-year-old girls from families below the poverty line have received at least one dose of the vaccine compared with girls from families above the poverty line (52 percent versus 42 percent). Also, a provision in the federal health care reform law requires private insurers to cover all ACIP-recommended vaccines with no co-pay requirements.

It’s a complex problem, acknowledged Dr. Zimet. For example, based on studies he has done involving the hepatitis B vaccine, he explained, “practical obstacles, like transportation to the clinic and how many children the mom is taking care of at home” can have an impact, particularly on adherence to the three-shot regimen.

A variety of approaches are being tested to increase vaccination rates, many of which are focused on moments or interactions that can influence awareness and decision making. Drs. Zimet and Brewer lead initiatives in their respective states that are part of the national Cervical Cancer-Free America campaign. In North Carolina, Dr. Brewer said, they are focusing their efforts on school-located health centers, where many children already receive other vaccines.

Other studies and programs are testing whether social media and text messaging can be used as educational platforms and reminder systems for adolescents and women.

A Mother’s Attitude Is Key

For younger girls, the available data strongly indicate that a single factor heavily influences whether they get vaccinated: their mother. “The gateway to adoption of the vaccine[s] is through the parents,” Chollette stressed. In particular, she continued, mothers are the key. “The mother’s values play a prominent role in whether girls go to the doctor and get all three doses according to schedule.”

Dr. Carlos and her colleagues are attempting to use cancer screening appointments as “teachable moments” for mothers of adolescent girls. In two separate studies, women undergoing breast and cervical cancer screenings who have adolescent daughters will receive tailored information about cervical cancer and the HPV vaccines. The studies will test different means of providing the information, including using a Web-based platform, and vaccination rates will be tracked via electronic medical records.

“From a public health perspective, it makes perfect sense to target mothers who come in for cancer screening,” Dr. Carlos said. Women undergoing their own cancer screenings “may be more receptive to acting on educational information about HPV prevention,” she continued. “Part of what this study is doing is encouraging this receptivity after being screened, and using that to encourage them to get their daughters vaccinated. The message is: ‘You’ve done something to protect yourself against cancer, so why not protect your daughter against HPV?’”

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

November, 2011|Oral Cancer News|

Test Markets Reveal Women Choose Dissolvable Tobacco

Source: Convenience Store News

WINSTOM-SALEM, N.C. — Since starting a second round of testing, R.J. Reynolds Tobacco Co.’s dissolvable tobacco products are proving popular among women.

The product line — Camel Sticks, Camel Strips and Camel Orbs –do not require spitting, which could be a deciding factor among female tobacco users. According to a report in the Winston-Salem Journal, females represented 45 percent of all adult smokers who bought Camel Sticks, Camel Strips and Camel Orbs during September and October. Of all adult tobacco users, 31 percent were women.

By comparison, the news outlet reported that adult males make up 85 percent of moist snuff and Camel Snus users.

R.J. Reynolds’ dissolvable line is currently being sold in Denver and Charlotte, N.C. The first round of testing took place in Columbus, Ohio Indianapolis and Portland, Ore.

“We have seen a noticeable appeal and interest of the dissolvable products with adult female tobacco consumers,” Reynolds spokesman David Howard told the newspaper.

Stephen Pope, an industry analyst and managing partner of Spotlight Ideas in England, said Reynolds may have discovered a niche with adult female tobacco users. “Clearly the figures for the dissolvable products make for fascinating reading and actually show that here could be a product that, if handled correctly, could well offer an opportunity for a special female-targeted product that could be as significant as Virginia Slims was for Philip Morris,” he said.

The dissolvable products “could prove to be the first viable smokeless tobacco products for females,” stated Bonnie Herzog, an analyst with Wells Fargo Securities LLC.

Reynolds has not said when a national rollout of the products will occur.

As the popularity of dissolvable tobacco grows, tobacco companies are sure to draw the attention of advocacy groups. Jeff Middleswart, portfolio manager for the Vice Fund of USA Mutuals, said having the Camel and Marlboro brands in dissolvable products is likely to intensify the debate among advocacy groups. One set says that smokeless tobacco products serve as gateways for teenagers to cigarettes; the other set sees the products as a way to reduce the risk of tobacco use compared with cigarettes.

“Anything tobacco will create criticism — it’s just the way of the world,” Middleswart said. “A new product that has the potential to gain market share is going to be a target.”

John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said he found it “disturbing that any smokeless tobacco product is now becoming popular among women.” His concern is that the dissolvable products may encourage women to use smokeless tobacco for the first time.

Dissolvable tobacco products have caught the eye of the Food and Drug Administration. The agency gained the authority to regulate the manufacturing, marketing and distribution of tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) took up the issue at its July meeting, the first step toward issuing regulations.

Colorado state officials have also put dissolvable tobacco products under the microscope. Just a few weeks after the TPSAC members began to take a closer look, the Colorado Department of Public Health and Environment held a hearing to begin their investigation into the products and their possible dangers, as CSNews Online previously reported.

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

November, 2011|Oral Cancer News|

US FDA approval for expanded use of Erbitux

Source: www.pharmabiz.com
Author: staff

The US Food and Drug Administration (FDA) has approved Erbitux (cetuximab), in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The approval, which is based on data from the landmark EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, makes Erbitux plus CT the first treatment regimen approved in 30 years with extended overall survival in patients with recurrent locoregional or metastatic SCCHN.

Erbitux (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumour cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITU Erbitux GFR blocks phosphorylation and activation of receptor-associated kinases, resulting in induction of apoptosis (cell death), inhibition of cell growth, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, Erbitux can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that Erbitux inhibits the growth and survival of tumour cells that express the EGFR. No anti-tumour effects of Erbitux were observed in human tumour xenografts lacking EGFR expression.

EXTREME, which was previously published in the New England Journal of Medicine, was a phase III open label, randomized, multi-centre, controlled trial. This study was conducted outside the US by Merck KGaA, Darmstadt, Germany, and used European Union (EU)-approved cetuximab. Erbitux provides approximately 22% higher exposure relative to the EU-approved cetuximab used in the EXTREME trial; these pharmacokinetic data, together with the results of the EXTREME trial and other clinical trial data establish the efficacy of Erbitux at the recommended dose. EXTREME showed that cetuximab plus CT in the first-line treatment of recurrent locoregional or metastatic SCCHN resulted in superior efficacy across clinically meaningful endpoints, including overall survival, progression-free survival, and objective response rate compared to CT. Cetuximab plus CT significantly extended patients’ median overall survival by 36% compared to patients who received CT alone (10.1 months vs. 7.4 months, respectively) [HR: 0.80; 95% CI: 0.64-0.98; p=0.034]. Cetuximab plus CT also significantly increased median progression-free survival by 67% (5.5 vs. 3.3 months, respectively) [HR: 0.57; 95% CI: 0.46-0.72; p<0.0001] compared to CT alone. A significant improvement in objective response rate was also demonstrated (36% vs. 20%, odds ratio, 2.33 [95% CI: 1.50-3.60]; p=0.0001).

Serious infusion reactions occurred with the administration of Erbitux in approximately 3 per cent of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. Healthcare providers should immediately interrupt and permanently discontinue Erbitux infusion for serious infusion reactions. Cardiopulmonary arrest and/or sudden death occurred in 2 per cent of patients with squamous cell carcinoma of the head and neck treated in a clinical trial with Erbitux and radiation therapy and in 3 per cent of patients with squamous cell carcinoma of the head and neck treated with EU-approved cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU) in the EXTREME trial. Healthcare providers should closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux administration.

Bristol-Myers Squibb and Lilly are committed to supporting patient access to ERBITUX and have put in place a number of programmes to help patients and providers. Destination Access, which is a Reimbursement Support Program, helps patient access by providing benefits investigation support, prior authorization assistance, appeals assistance and patient assistance.

November, 2011|Oral Cancer News|