The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.
The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.
"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device
On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.
VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.
The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device
In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.
Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.
Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.
Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.
Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088
Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.
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Tuesday, December 16, 2008
FDA Announces Class I Recalls of Two Unapproved Devices
Wednesday, December 10, 2008
Leading U.S. Cancer Organizations Unite Against the Growing Global Cancer Burden
/PRNewswire-USNewswire/ -- Despite the recent good news that cancer incidence and death rates for men and women in the United States continue to decline, cancer is projected to become the leading cause of death worldwide in the year 2010, and low- and middle-income countries will feel the impact of higher cancer incidence and death rates more sharply than industrialized countries. The nation's leading cancer organizations joined forces today at an event called Conquering Cancer: A Global Effort, to focus attention on the growing global cancer burden and discuss efforts needed to address the problem. The International Agency for Research on Cancer (IARC) released the new edition of the World Cancer Report. The American Cancer Society, the Lance Armstrong Foundation, and Susan G. Komen for the Cure discussed how each organization is addressing the global cancer problem and together issued a call to action for the incoming United States presidential administration and Congress. In addition, a new international documentary film entitled "Cancer Is..." was premiered.
According to the new report, the burden of cancer doubled globally between 1975 and 2000. It is estimated that it will double again by 2020 and nearly triple by 2030. This translates to far greater numbers of people living with - and dying from - the disease. The report estimates that there were some 12 million new cancer diagnoses worldwide this year, and more than seven million people will die from the disease. The projected numbers for the year 2030 are 20-26 million new diagnoses and 13-17 million deaths.
The growing cancer burden includes global increases of incidence of about one percent each year, with larger increases in China, Russia, and India. Reasons for the increased rates include adoption of Western habits in less developed countries, such as tobacco use and higher-fat diets, and demographic changes, including a projected population increase of 38 percent in less developed countries between 2008 and 2030.
In addition to increases in cancer incidence and death rates, the report identifies challenges in cancer care, especially in Africa, where pain management and palliative care are very limited because any use of narcotics is prohibited by law in several countries.
Sharing the stage were John R. Seffrin, Ph.D., chief executive officer, American Cancer Society; Lance Armstrong, founder and chairman, Lance Armstrong Foundation; Hala Moddelmog, president and chief executive officer, Susan G. Komen for the Cure; Peter Boyle, B.Sc., Ph.D., D.Sc.(Med), director, International Agency for Research on Cancer; Alejandro Mohar Betancourt, M.D., Sc.D., director, National Cancer Institute of Mexico, and Bill Gregory, a throat cancer survivor.
The American Cancer Society's Seffrin said, "For all of our 95 years the Society has pursued the vow of our founders to eliminate cancer in all humankind. We recognize that cancer strikes without regard to borders or socioeconomic status, and we support cancer control initiatives in more than 20 countries, and fund capacity building and tobacco control grants in some 70 countries - including the launch next week of our tobacco Quitline(R) in India. It is my hope that by bringing proven interventions to places in the world impacted most by this disease, we can diminish needless suffering and save many lives."
Armstrong explained his foundation's international work, saying, "Since announcing the launch of our international cancer awareness campaign at the Clinton Global Initiative less than three months ago, we are already in discussions with more than 20 nations, NGOs and business leaders to advance this issue. Even in a challenging economy, people realize that with cancer there is progress to be made and prevention measures to be taken."
"Breast cancer alone will be diagnosed in 25 million women over the next 25 years. Susan G. Komen for the Cure already has changed the way we talk about and treat breast cancer in the United States, and we're bringing what we've learned to developing countries in Asia, Africa, Latin America, the Middle East and Eastern Europe. This 'global health diplomacy' approach, with its focus on better access to care, is already educating and empowering women worldwide, and it is critical if we're to save lives and resolve the growing global cancer crisis," said Hala Moddelmog, president and CEO of Susan G. Komen for the Cure.
Explaining the results of the report, Dr. Boyle said, "The rapid increase in the global cancer burden represents a real challenge for health systems worldwide. However, there is a clear message of hope: although cancer is a devastating disease, it is largely preventable. We know that preventive measures such as tobacco control, reduction of alcohol consumption, increased physical activity, vaccinations for hepatitis B and human papillomavirus (HPV), and screening and awareness could have a great impact on reducing the global cancer burden."
"We appreciate the opportunity to stand with leading cancer organizations in the United States to make global cancer a priority. In Mexico, we have seen the power of the government working with the NGO's, and look forward to collaborating globally to conquer cancer," said Dr. Mohar of Mexico's National Cancer Institute.
The six call to action steps issued by the three U.S. organizations include: 1) making vaccines that prevent cancer causing infections more widely available to low-income nations, including specifically combating cervical cancer through Global Alliance for Vaccines and Immunizations (GAVI) efforts to make the HPV vaccine accessible and affordable; 2) committing to a comprehensive tobacco control approach in the U.S., which includes taking measures proven effective in reducing smoking rates and having Congress grant the Food and Drug Administration (FDA) authority to regulate tobacco; 3) ratifying immediately the Framework Convention on Tobacco Control (FCTC), the first ever global public health treaty that sets forth comprehensive measures to reduce health and economic impacts of tobacco; 4) supporting efforts of non-governmental organizations to build advocacy and resources, empower survivors and reduce suffering in low- to middle-income countries by working with governments, medical professionals and the corporate sector to enable individuals to adopt healthier behaviors; 5) promoting culturally sensitive risk reduction and education campaigns by leveraging our own successful U.S. efforts to help build capacity of nongovernmental organizations in other countries; and 6) investing in cancer research and expanding access to prevention and early detection measures in the U.S., with a specific focus on increasing federal funding of medical research.
The news conference also featured the domestic launch of a new documentary film series focused on the global cancer problem titled "Cancer Is..." The documentary is narrated by former U.S. President George H. W. Bush, and was produced by France's Cemil Alyanak, a renowned expert on global health communications.
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Friday, September 12, 2008
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.
“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”
The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.
HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.
For most women, the body’s own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.
Regarding the prevention of vulvar and vaginal cancer, Gardasil’s manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study—the other half did not receive Gardasil and served as a control group.
Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18.
There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.
Gardasil’s label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.
No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.
Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil’s approved uses.
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Tuesday, July 29, 2008
American Cancer Society, National Medical Association Announce Collaboration to Reduce Cancer Disparities
PRNewswire-USNewswire/ -- The American Cancer Society and the National Medical Association today announced a three-year strategic collaboration intended to educate the general public, physicians, and other health professionals about best practices to achieve optimal outcomes in cancer prevention and early detection practices, and treatment among ethnic minority and underserved population groups. This collaboration represents a significant commitment by both organizations to target and eliminate cancer disparities specifically among racial and ethnic minorities by reducing inequalities in access to information and screening services, quality care and treatment, and end-of-life support.
Racial and ethnic minorities can often face numerous obstacles to receiving equal access to quality cancer prevention, early detection and treatment services. Many lack health insurance, live in rural or inner-city communities, have low incomes, and experience language barriers, racial bias and stereotyping. They also tend to receive lower quality health care than whites even when insurance status, income, age and severity of conditions are comparable.
"Promoting increased awareness and understanding of cancer prevention, early detection and treatment to help reduce health disparities is a nationwide priority for the American Cancer Society, said Otis W. Brawley, M.D., chief medical officer, American Cancer Society. "Collaborations with pre-eminent organizations such as the National Medical Association are central to the Society's strategy to reach racial and ethnic minorities with appropriate health information."
"Strategic partnerships with organizations like the American Cancer Society amplify the National Medical Association's ability to touch and impact lives through community action and healthcare provider education," said Nelson L. Adams, III, M.D., president, National Medical Association.
Initial goals for the collaboration include developing and distributing culturally relevant consumer and professional materials that focus on prevention, early detection, and treatment of breast, prostate, and colorectal cancer, as well as proper nutrition and physical activity. The effort will also target faculty and alumni of Historically Black Colleges and Universities, NMA clinical specialty sections, regions, states and local members, community-based organization leaders in the African-American and Hispanic/Latino communities, and large African-American and Hispanic/Latino church congregations nationwide.
