FDA – Page 11 – Oral Cancer News

FDA bad news for snus?

Source: www.cspnet.com Author: staff The subject of putting tobacco under the control of the federal Food & Drug Administration (FDA) has divided the industry. Such regulation may also end product innovation, according to Forbes magazine. The report cites Reynolds American Inc.'s Camel Snus, the spit-free flavored pouch of pasteurized tobacco sold chilled in tins, as an example of the kind of innovation may be the last of its kind after this year's tobacco regulation bill, sponsored by Senator Edward Kennedy (D-Mass.), turns into law. The legislation is expected to easily pass through the Senate on Tuesday or Wednesday, after getting cleared by the House in April, and then quickly get a presidential signature. After test runs in Columbus, Ohio, and Portland, Ore., three years ago, R.J. Reynolds Tobacco Co., Winston-Salem, N.C., now sells Camel Snus in 100,000 locations nationwide. A tin of 15 costs $4.50. (Click here for previous CSP Daily News coverage.) The bill has divided the industry. Altria Group Inc., which makes market-leading Marlboro cigarettes though Phillip Morris USA, Richmond, Va., helped write the bill, which critics say will institutionalize that company's market share. The No. 2 tobacco maker, Reynolds American, which makes Camels through RJR, has been waging the battle against it. Altria is testing Marlboro Snus in Dallas and Indianapolis. (Click here for previous CSP Daily News coverage of Altria's other tobacco products strategy.) Kennedy's bill would allow the FDA to play gatekeeper to tobacco products like snus and newer smokeless tobacco lozenges and sticks. The [...]

Oral Cancer Foundation News Team - A2009-06-02T20:50:28-07:00June, 2009|Oral Cancer News|

Samuel Broder: Why Isn’t There a Gardasil for Men?

Source: Health.usnews.com Author: Samuel Broder, M.D. There's an HPV vaccine for women; why don't men have one? Why was the vaccine against the cancer-causing, sexually transmitted HPV virus not approved for men at the same time it was for women? Is there any reason to think that men and women would react to it differently? Interesting question. First, a little background. Gardasil is a genetically engineered vaccine to immunize girls and women ages 9 to 26 against four types of human papillomavirus (HPV). HPV is the name given to a family of viruses, many of which can be transmitted from one partner to another through sexual activity. HPV may represent the most frequent sexually transmitted infection in the United States. It is estimated that over 6 million people become infected by a sexually related form of HPV every year. Some estimates suggest that over half of all sexually active males and females become infected at one point or another in their lifetimes. Certain types of HPV can sometimes evade the body's immune system and, when they do, establish a state of persistent infection. That in turn may cause certain cancers. Indeed, this is now recognized as the major cause of cervical cancer and related conditions, and vaccines that immunize people against HPV could make a dramatic impact against these diseases. Gardasil is the first vaccine in the United States approved for the prevention of cervical cancer and precancerous cell abnormalities in the cervix and also certain precancerous conditions in the [...]

Charlotte Parker2009-05-19T15:39:45-07:00May, 2009|Oral Cancer News|

Glaxo’s cervical cancer vaccine faces US battle

Source: Forbes.com Author: Linda A. Johnson New studies show GlaxoSmithKline PLC's vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years. Cervarix, Glaxo's vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil's maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006. Late in 2007, the Food and Drug Administration declined to approve approve Cervarix. GlaxoSmithKline submitted a new application on March 30 that included final data from an 18,000-woman study recently completed. Final results from that study and two others are being presented this weekend at a conference in Sweden on papillomavirus. FDA is expected to decide whether to approve Cervarix within several months. If it does, analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said doctors who have prescribed Gardasil for a few years may see no reason to switch - unless GlaxoSmithKline convinces them its product is much more effective or has fewer side effects. Both vaccines target the two types of HPV that cause about 70 percent of cervical cancers, types 16 and 18, and data indicate both are about 98 percent effective. But Merck also [...]

Charlotte Parker2009-05-08T18:53:28-07:00May, 2009|Oral Cancer News|

Oral Cancer Foundation calls for FDA authority over tobacco marketers

Source: Author: The Oral Cancer Foundation today called for the U.S. Senate to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products in response to the tobacco industry's most aggressive marketing campaign targeted at women and girls in over a decade. The U.S. House of Representatives voted to give the FDA such authority approximately two weeks ago. "The percentage of oral cancer patients represented by women has increased tremendously over the past four decades, and we believe the marketing efforts of the tobacco industry is a major causal factor," said Brian Hill, founder of the Oral Cancer Foundation. "Before Virginia Slims began aggressively targeting women in the 1960s, roughly one-in-ten oral cancer victims was female. Since then, the ratio has quintupled to one-in-two." Hill also noted that lung cancer surpassed breast cancer as the number one cancer killer of women in 1987, and that while overall cancer rates are declining for men and women, lung cancer is not declining among women. Moreover, smoking puts women and girls at greater risk of a wide range of other deadly diseases, including heart attacks, strokes and emphysema. Hill cited "Deadly in Pink: Big Tobacco Steps Up Its Targeting of Women and Girls," a comprehensive report recently issued by the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Robert Wood Johnson Foundation and Campaign for Tobacco-Free Kids. The report studied numerous tobacco marketing campaigns, images from which can be found at www.tobaccofreekids.org/deadlyinpink. "In reading this report, three [...]

Oral Cancer Foundation News Team - A2009-04-17T08:05:22-07:00April, 2009|OCF In The News, Oral Cancer News|

Cancer vaccines get coveted “Orphan” go-ahead

Source: www.zampbioworld.org/bionews Author: staff Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official. The vaccine candidates were licensed by Gliknik, Inc., located at the University of Maryland BioPark. Orphan status for the vaccines means that the startup firm will receive tax credits and marketing incentives from the Food and Drug Administration (FDA), which may hasten its development of the treatments. The vaccines were eligible because they are personalized for a limited number of patients. “Advanced head and neck cancer is a challenging disease with limited treatment options. Even with chemotherapy, radiation, and surgery, people with advanced head and neck cancer may have a limited life expectancy of six to eight months,” says David Block, MD, MBA, co-founder, president, and CEO of Gliknik. The vaccines were designed in a precise manner to boost the immune system. They were invented by Scott Strome, MD, a professor at the University of Maryland School of Medicine. “The survival of head and neck cancer patients has not really improved in 30 years,” says Strome, who included in the two vaccines certain compounds that act as biological recognition points for specific substances associated with some head and neck cancerous tumors. Head and neck cancer is different from brain cancers and may include cancers of the tongue, tonsils, nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx. Any proposed treatment for the total number of all head [...]

Oral Cancer Foundation News Team - A2009-04-10T12:49:39-07:00April, 2009|Oral Cancer News|

A vaccine debate once focused on sex shifts as boys join the target market

Source: www.washingtonpost.com Author: Rob Stein When a vaccine designed to protect girls against a sexually transmitted virus arrived three years ago, the debate centered on one question: Would the shots make young girls more likely to have sex? Now the vaccine's maker is trying to get approval to sell the vaccine for boys, and the debate is focusing on something else entirely: Is it worth the money, and is it safe and effective enough? "We are still more worried about the promiscuity of girls than the promiscuity of boys," said Susan M. Reverby, a professor of women's studies and medical history at Wellesley College. "There's still that double standard." The shift in the discussion about Gardasil illustrates the complex interplay of political, economic, scientific, regulatory and social factors that increasingly influence decisions about new types of medical care. For the vaccine, the new dynamic reflects a strategic tack by Gardasil's critics, growing concern about health-care costs, fears about whether medical treatments are being vetted adequately and stubborn biases about gender, experts say. "There is the cost, the safety, the boys versus girls," said Susan F. Wood, a professor of public health at George Washington University. "These are some of the complexities that are going to have to be addressed one way or the other with this vaccine." Gardasil protects against the human papillomavirus, the most common sexually transmitted infection. HPV causes genital warts and, in women, can lead to cervical cancer -- a disease that strikes about 10,000 American women [...]

Oral Cancer Foundation News Team - A2009-03-27T08:30:59-07:00March, 2009|Oral Cancer News|

First DNA Test for Two Types of Human Papillomavirus Approved by FDA

Source: FDA News The first DNA test that identifies the two types of human papillomavirus (HPV) causing the majority of cervical cancers among women in the United States is approved by the U.S. Food and Drug Administration. The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer. A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample. The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types. In women age 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease. “Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. HPV is the most common sexually transmitted infection in the United States. The U.S. Centers for [...]

Webmaster2009-03-16T13:13:26-07:00March, 2009|Oral Cancer News|

Avastin, Erbitux combo proves dangerous

Source: www.newsinferno.com Author: staff Combining Avastin and Erbitux with chemotherapy to treat colon cancer may actually make patients sicker, and cause their tumors to grow faster. According to a new Dutch study, using Avastin and Erbitux to increase the effectiveness of chemotherapy is a complete failure, and could actually cut the survival time of patients by as much as a month. Avastin was approved by the Food & Drug Administration (FDA) in 2004 to treat colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. Last year, the FDA also approved Avastin as a breast cancer treatment. Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. Erbitux is indicated for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses a protein called an Epidermal Growth Factor Receptor. Erbitux was approved by the FDA to treat advanced colon cancer in 2004, and again in 2006 for treating squamous cell carcinoma of the head and neck It was theorized that adding Erbitux and Avastin to chemotherapy could boost benefits, but unfortunately, the Dutch study has proven the opposite to be true. The study looked at 732 patients; 378 patients where treated with chemo plus Avastin. The remaining patients received chemo along with Avastin and Erbitux. Median progression-free survival was 10.7 months among those receiving only Avastin with [...]

Oral Cancer Foundation News Team - A2009-02-07T13:44:11-07:00February, 2009|Oral Cancer News|

Dietary supplements: friend or foe?

Source: patient.cancerconsultants.com Author: Eleanor Mayfield With research pointing to pros and cons of vitamin and mineral supplements, these dietary decisions become increasingly complex. Here’s a quick quiz: 1. Are you a cancer patient or survivor? 2. Do you take any dietary supplements such as vitamins, minerals, or herbs? 3. Have you discussed with your doctor the pros and cons of using these supplements? If you answered yes to questions 1 and 2 and no to question 3, you’re not alone. A recent review in the Journal of Clinical Oncology found that supplement use is widespread among cancer patients and longer-term survivors and that most don’t discuss their supplement use with their doctors. In fact, in different studies 64 to 81 percent of respondents reported using vitamin or mineral supplements. Up to 68 percent of doctors were unaware of supplement use by their patients. Cancer patients and survivors tend to use dietary supplements at higher rates than the rest of the U.S. population, the review found. Supplement use was highest among women, breast cancer survivors, and people with higher levels of education. People who take supplements generally believe that doing so will benefit their health. In studies included in the review, the reported reasons for supplement use included strengthening the immune system, helping cope with stress, improving the chance of a cure, and helping the user feel better. Users may assume that the supplements they take can’t do them any harm. Research findings suggest, however, that supplements can sometimes be harmful. [...]

Oral Cancer Foundation News Team - A2008-12-18T13:11:44-07:00December, 2008|Oral Cancer News|

FTC warns of bogus cancer cure claims

Source: CNN Money.com WASHINGTON (AP) -- The Federal Trade Commission charged five companies with making false and misleading claims for cancer cures and said Thursday that it has reached settlements with six others. "As long as products have been sold there has been somebody out there selling snake oil to consumers," said Lydia Parnes, director of the FTC's bureau of consumer protection. She said the agency, along with the Food and Drug Administration and Canadian authorities, is launching a consumer education campaign warning about bogus claims for cures. "There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure, or treat cancer of any kind," said Parnes. The products the companies marketed include essiac teas and other herbal mixtures, laetrile, black salve - a corrosive ointment - and mushroom extracts. Douglas Stearn of the FDA said his agency is concerned that people may forego effective cancer treatments when choosing these products. In addition, he said, some of these unproven products may have dangerous interactions with other drugs. "We would urge folks to talk to their doctors," said Stern. Parnes said more than 100 warning letters were sent out and many advertisers dropped or changed their claims. Of the complaints resolved by settlements, she said companies paid restitution ranging from $9,000 to $250,000. The remaining five complaints of false and deceptive advertising will go before administrative law judges, she said. Those cases are Omega Supply, San Diego, Calif.; Native Essence Herb Company, El Prado, N.M.; Daniel Chapter [...]

Webmaster2008-09-20T17:13:51-07:00September, 2008|Oral Cancer News|