Source: Thompson Reuters
According to a recent report by Robert Kelley, vice president of healthcare analytics at Thomson Reuters, an estimated $700 billion is wasted annually on healthcare practices and procedures in need of revision.
Examples of such waste include: A paper-based system which discourages the sharing of medical records (6 percent of annual overspending), thank you lack of technology utilization and HIPPA; Overuse of antibiotics and lab tests accounts for some 37 percent of healthcare waste ($200 to $300 billion a year); Fraud is responsible for 22 percent of healthcare waste ($200 billion a year) in fraudulent Medicare claims, kickbacks for referrals for unnecessary services and other scams; Administrative inefficiency and redundant paperwork account for 18 percent of healthcare waste; Medical mistakes account for 11 percent ($50 billion to $100 billion); and, Preventable conditions such as uncontrolled diabetes cost $30 billion to $50 billion a year.
The report also found that there is a shortage of US primary care doctors (compared to specialists) which leads to wasteful use of emergency rooms, for primary care issues.
So what does this all add up to? Well, $505 to $850 billion in costs per year certainly, forcing Americans to spend more per capita and the highest percentage of GDP on healthcare than any other “developed” country while managing the paradox of maintaining an unhealthier population with higher incidence of diabetes, obesity and heart disease and neonatal deaths than other such countries. All is not entirely doom and gloom. Americans still have more access to generally more advanced healthcare with less wait involved. However, if the push from the US Government for mandated reform doesn’t make it clear, the current system requires some significant revision.
~Posted by D.M. Schwadron, Esq.
Drug not shown to be safe and effective in breast cancer patients
Erica Jefferson, December 2010 FDA Information
The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significance risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.
“After careful review of the clinical data, we are recommending that the breast cancer indication for Avasin be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avasin lived longer and patients receiving Avasin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”
Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.
Oncologists currently treating patients with Avasin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.
The agency has informed Genentech, Avastin’s manufacturer, of its approval to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, the FDA will begin proceeds to remove the breast cancer indication.
Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100,” which evaluated the drug in patients who had not received chemotherapy for the metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.
After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.
Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.
On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.
FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.
Gayle Lewis, Esquire
J. Painter, Nature Genetics, December 2010
December 14, 2010 – Women with one of two genetic variants may be more likely to develop endometriosis, according to a new study that may offer new clues about the cause of the mysterious condition.
Researchers say it’s the first study to show a genetic link to the disorder that affects between 6% and 10% of women of childbearing age.
Endometriosis is the abnormal growth of cells similar to those found inside the uterus on other areas of the body, such as the ovaries and bowel. The growths can lead to inflammation, pelvic pain, painful menstrual periods, and infertility in some women.
“We’ve known for some time that endometriosis is heritable, but until now we have been unable to find any robust genetic variants that influence a women’s risk of developing the disease,” researcher Krina Zondervan, a Wellcome Trust Research Career Development Fellow at the University of Oxford in England, says in a news release.
“Our study is a breakthrough because it provides the first strong evidence that variations in DNA make some women more likely to develop endometriosis,” Zondervan says. “We now need to understand the effect of these variations on cells and molecules in the body.”
New Endometriosis Genes Found
In the study, published in Nature Genetics, researchers compared the genes of 5,586 women with endometriosis to 9,331 women without endometriosis.
The results showed that women with two different genetic variants were more likely to have endometriosis.
The first was located on chromosome 7 and is thought to be involved in the development of the uterus and its lining. The second was on chromosome 1, which is involved in the development of the female reproductive tract.
Researchers say it further studies confirm these two genetic variants as key players in the development of endometriosis, it could lead to better ways to diagnose and treat the disease.
Gayle Lewis, Esquire
Media Inquiries: Shelly Burgess
The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.
“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation of chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.
Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1,2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.
Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all the indications for use approved by the FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.
Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.
As of May 31, 2010 more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc., of Whitehouse Station, N.J. The most commonly reported adverse events include 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. This can be prevented by 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.
Gayle Lewis, Esquire