FDA Announces New Labeling Changes for Regranex

The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The warnings section of the product has been updated to include a boxed warning and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

To read about Regranex and FDA's follow-up communication go to:

Becaplermin (marketed as Regranex) Information

Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program, as described below.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

Water Bottle Safety a Concern

The safety of plastic water bottles continues to rise as an issue of concern to consumers. A University of Georgia expert says the key lies in using the right plastics the right way and keeping your water bottles sanitized.

“The FDA regulates materials and substances used for plastic packaging for water bottles as indirect food additives,” said Elizabeth Andress, a UGA Cooperative Extension food safety specialist. They “assess the migration potential of plastics and the substances with which they are made.”

"One of the common concerns surrounding plastic water bottles is whether or not the chemicals can migrate from the plastic into the water. Although convenience-size pre-filled plastic water bottles are made for single use, they are tested for both single and repeated use," Andress said. "These pre-filled bottles are made from PET plastic, a kind of polyethylene," she said.

Lately, Andress has heard concerns that focus on polycarbonate plastic, a hard plastic that is designed for repeated daily use. These concerns also focus on whether or not chemicals can migrate from the plastic into water or other liquids stored in the bottles.

“There’s still not scientific evidence to disallow the use of this plastic,” she said. “Even the amount of leaching that can occur is not agreed upon. And, it would seem, if it occurs, to be well below acceptable levels.”

In freezer, use plastics designed for freezing

Other plastic bottle concerns focus on whether the bottles should be used in the freezer. Again, Andress said, studies in this area are not yet conclusive.

“We would not automatically expect freezing to cause a problem unless the plastic itself goes through some breakdown,” she said. “But repeated freezing and thawing of plastic not intended to be used that way could lead to structural breakdown.”

"Until research studies determine an actual health risk related to plastic water bottles, there are ways to reduce your family’s health risks," she said.

Although pre-filled water bottles in the grocery stores and vending machines are not deemed chemically unsafe if used repeatedly, they are not intended to last structurally through prolonged re-use.

Use pre-filled bottles once

Andress discourages repeated use of these bottles. Above all, she recommends using plastic bottles only as the manufacturer intended.

If you do choose to buy and use a polycarbonate plastic bottle for water and other liquids, Andress says to take steps to reduce any microbiological risks. Wash the bottle with warm soapy water every day. Use a clean bottle brush to clean in and around the bottle neck. Scrub the lids with a bottle brush, too. Rinse well and allow the bottle and lid to air dry.

By Allie Byrd
University of Georgia

Allie Byrd is a student writer with the University of Georgia College of Agricultural and Environmental Sciences.

Which Smoking Cessation Treatment Works Best? Your Genes May Hold the Clue

Kicking the habit may soon become easier for the nation's 45 million smokers. For the first time, researchers have identified patterns of genes that appear to influence how well individuals respond to specific smoking cessation treatments.

Scientists at Duke University Medical Center, the National Institute of Drug Abuse, University of Pennsylvania and Brown University scanned the entire human genome in a comprehensive search for genes that could determine treatment outcome. They identified several genetic variations that seem to indicate the likelihood of success or failure of nicotine replacement therapy (NRT) and bupropion (Zyban).

Their findings appear in the June issue of Archives of General Psychiatry.

"This takes us a big step forward in being able to tailor treatment to individual smokers to provide the therapies that are most likely to benefit them," explains Jed Rose, Ph.D., director of Duke's Center for Nicotine and Smoking Cessation Research and one of the study's authors. "In a few years, a simple blood test may provide physicians with enough information to recommend one treatment over another."

In previous studies, the researchers performed the first genome-wide scan of more than 520,000 genetic markers taken from blood samples of smokers entered in a quit-smoking trial. When they compared the genes of smokers who had successfully kicked the habit to those who failed to quit, they found clusters of positive results in gene variants present more frequently in the successful quitters. The current findings "confirmed that most of the genetic markers we previously identified remain significant predictors of who will have the most likelihood of success," says Rose.

George Uhl, MD, PhD, chief of the molecular neurobiology research branch at the National Institute on Drug Abuse and lead author of the study, says their work marks significant inroads in the study of smoking cessation. "It helps us understand why some people are able to quit smoking more easily than others."
The latest findings, he added, "provide potential clues to match individuals with treatments"

Both NRT and Zyban have proven effective at helping people abstain from smoking, but use different pharmacological mechanisms to achieve that abstinence.

In the current study, Dr Uhl's laboratory analyzed the DNA of 550 smokers entered into quit-smoking studies in which they were randomly assigned to either placebo, NRT or bupropion. The studies took place at Duke, University of Pennsylvania or Brown University. They assessed quit-smoking success several weeks later and found 41 gene variants specific to smokers who successfully stopped smoking using NRT, and 26 bupropion-specific genes. "Everybody has some version of these genes, but different people have distinct variants," Rose said.

The researchers stress that the presence of these genetic variants alone is not enough to completely predict specific treatment success or failure. Rose also cautioned that not enough is known, yet, about what role the genes play. "It may be that each gene is adding its own influence. We still don't know if each gene interacts with each other or if each gene is casting its vote and we're simply counting up all the votes."

In their next phase of research, currently ongoing, the researchers are working on confirming these initial findings. In the near future, they plan to expand their studies to include varenicline (Chantix) and other smoking cessation treatments. "We also plan to look at genetic predictors of behavioral therapies to see who they will work best in," Rose said.

The study was supported by the National Institutes of Health, Philip Morris USA Inc. and Glaxo SmithKline.

Colleagues who contributed to this study include Caryn Lerman, University of Pennsylvania, Philadelphia, PA; Ray Niaura, PhD, Brown University, Pawtucket, RI; and Sean P. David, Brown University, Pawtucket, RI.

Smoking Early In Pregnancy Raises Risks Of Heart Defects In Newborns

Mothers who smoke early in pregnancy are more likely to give birth to
infants with heart defects, according to a study funded by the Centers
for Disease Control and Prevention (CDC).

The study, published in the April issue of Pediatrics, shows that women
who smoked anytime during the month before pregnancy to the end of the
first trimester were more likely to give birth to infants with certain
congenital heart defects (CHDs) compared to women who did not smoke
during this time period. The association was stronger for mothers who
reported heavier smoking during this time period.

"Most people know that smoking causes cancer, heart disease and other
major health problems," said Margaret Honein, Ph.D., MPH, CDC's National
Center for Birth Defects and Developmental Disabilities, one of the
researchers. "The indisputable fact is that women who smoke during
pregnancy put themselves and their unborn babies at risk for other
health problems."

The findings from the study, "Maternal Smoking and Congenital Heart
Defects," were based on the National Birth Defects Prevention Study,
which is the largest population-based study ever done on the causes of
birth defects in the United States. Nine states participated in the
study: Arkansas, California, Georgia, Iowa, Massachusetts, New York,
North Carolina, Texas and Utah. This research included 3,067 infants
with CHDs and a comparison group of 3,947 infants with no major birth
defects.

The study found that septal heart defects - a hole in the heart between
the left and right heart chambers, which disrupts the flow of blood and
oxygen to the body - were the most common defect found among infants who
were born with a cardiac defect. Researchers also found conotruncal
(poor blood circulation from lower heart chamber), right-side
obstructive (blood is blocked from flowing freely from the right side of
the heart) and left-side obstructive (blood is blocked from flowing
freely from left side of heart) defects.

CHDs are the most common type of birth defect, occurring in eight to 10
of every 1,000 live births in the United States. Many infants with CHDs
die in the first year of life, and infants who survive often require
numerous surgeries, lengthy hospitalizations and a lifetime of treatment
for related disabilities.

Women who smoke should know that in addition to smoking being a possible
cause for heart defects, the following are also of concern:

* Smoking makes it harder for a woman to get pregnant.
* Women who smoke during pregnancy are more likely than other women to
have a miscarriage.

* Smoking during pregnancy causes major health problems for both mother
and baby. For example, smoking is one of the causes of problems with the
placenta - the source of the baby's nutrition and oxygen during
pregnancy.

* Smoking during pregnancy can cause a baby to be born too early and
have low birth weight - making it more likely the baby will become sick
or die.
* Babies born to women who smoke are more likely to have a cleft lip or
cleft palate - types of birth defects.
* Smoking during and after pregnancy is one of the causes of Sudden
Infant Death Syndrome (SIDS).

For information about birth defects, please visit www.cdc.gov/ncbddd,
for more information about smoking please visit www.cdc.gov/tobacco or
call 1-800-CDC-INFO.

Mayo Clinic Research Shows U.S. Intensive Care Units' Prevention of Pneumonia in Critically-ill Patients Generally Strong; Identifies Area of Improvem

mdash; Mayo Clinic researchers found that the frequency with which critically-ill patients developed ventilator-associated pneumonia (VAP) is approximately the same at a multidisciplinary medical center such as Mayo Clinic compared to the average VAP-risk rate for 211 hospitals in the National Healthcare Safety Network (NHSN). This is good news for patients because it suggests that care levels are generally strong across the U.S. in intensive care units, which is where the sickest patients — many of them elderly — are treated. This is true despite variety in levels of care offered by individual hospitals.

The study also is helpful because it identified the fact that the VAP-risk rate for patients in a specific kind of intensive care unit, the trauma intensive care unit (TICU), was lower at Mayo Clinic, as compared to the NHSN average. This kind of finding is what the U.S. Centers for Disease Prevention and Control (CDC) intended when it made the NHSN data available in a June 2007 report. In that report, CDC analysts instructed hospitals to use the data to guide local prevention strategies and other quality improvement efforts aimed at reducing infection rates. The Mayo group presented its findings this week at the American Thoracic Society's 2008 International Conference in Toronto. The data showed that the Mayo Clinic risk rate for VAP in intensive care units (ICU) for trauma patients averaged 3.4 per 1,000 days of mechanical ventilation. This compares to the VAP average of 10.2 per 1,000 days in trauma ICUs participating in the NHSN.

The reason for this variation is not known, and the difference needs to be validated through further study. But these preliminary results identify a need for improvement to lower the 10.2 risk rate.

Significance of the Mayo Clinic Research

"The topic is an important one to study because developing VAP is a potential risk for all critically-ill patients who must be on an invasive mechanical ventilator greater than 48 hours," says Mayo lead author Ahmed Mahmoud, M.B.B.S.

"As the demographics of this country change, the number of frail elderly who end up hospitalized and needing ventilation in a TICU is likely to increase," adds senior author Bekele Afessa, M.D., of Mayo's pulmonary and critical care medicine group. "We want to do our best to eliminate the potential for any additional disease burden to patients. Understanding the risk of VAP in all ICU settings is a step toward that."

The Mayo study is the first to compare VAP-risk rates at (NHSN) hospitals to Mayo Clinic's experience as a single advanced medical center with integrated intensive care units and a unified approach to infection control. Mayo Clinic researchers studied 206 patients treated at Mayo Clinic's various ICUs between February and August 2007, and who consented to participate in the study.

Results

The Mayo Clinic comparison also showed that:

*The VAP-risk rate varies depending on the ICU medical specialty, from a low of 2.8 at Mayo Clinic's vascular/thoracic surgery intensive care unit and 5.7 in the analogous units of NHSN to a high of 10.2 per 1,000 ventilator days in NHSN trauma intensive care units.
*The Mayo VAP-risk data range from 2.8 to 8.2 across various kinds of ICUs at Mayo Clinic; 2.8 for vascular and thoracic surgery, 8.2 for neurology and 4.9 for cardiac surgery.
*Of the 19 bacteria isolated from the patients, the Mayo study found that the most common pathogen causing VAP was Pseudomonas aeruginosa. This information is helpful in determining the best antibiotic treatment for VAP. Acting on it could perhaps help prevent levels of VAP elsewhere.

Arthritis Drugs and Cancer?

HHH Note: Sometimes, articles just catch our eyes. This one really made us sit back and think. What kind of future are we giving some of our youth?

All drug manufacturers are required to provide adverse reaction data to the FDA. Sometimes, the data can show some surprising and unexpected results after patient numbers increase dramatically. Does this mean some drugs have to be pulled from the market? What it really means is that we as consumers must investigate the drugs and question the physicians to be sure we are willing to take the risks for ourselves and our children. If you have an adverse reaction to any drug, please make sure your physician knows. You can also alert the FDA. They will keep the information on file.


FDA Probes Arthritis Drug Link To Cancer

June 4, 2008
The U.S. Food and Drug Administration has announced an investigation into a class of drugs used to treat arthritis, over concerns they might be linked to the development of cancer....

Read the story.

Public Funding Impacts Progress of Human Embryonic Stem Cell Research

Bolstered by supportive policies and public research dollars, the United Kingdom, Israel, China, Singapore and Australia are producing unusually large shares of human embryonic stem cell research, according to a report from the Georgia Institute of Technology in the June 2008 issue Cell Stem Cell. Aaron Levine, assistant professor of public policy and author of the book Cloning: A Beginner’s Guide, studied how countries output of research papers related to human embryonic stem cell research compared to their output in less contentious fields. He found that even though the United States still puts out far more research in this field than any other single country, when one compares the amount of research in human embryonic stem cells to other forms of research in molecular biology and genetics, the U.S. lags behind.

“The U.S. is still the largest producer of research in this field, but compared to other similar fields, our share is smaller,” said Levine, assistant professor in Georgia Tech’s Ivan Allen College of Liberal Arts. “You have to ask yourself, are we happy producing this relatively small share?”

In comparison, the study showed that the U.K. and Israel were producing substantially more research in this area than in other fields. According to the study, the U.K. produced 5.3 percent more research related to human embryonic stem cells than research performed in other areas of molecular biology and genetics, while Israel produced 4.6 percent more research. Levine attributed that to the long-held public and political support of human embryonic stem cell research in those countries.

“Both the U.K. and Israel have long-standing policies that support research in this field,” said Levine, “And this support seems likely to have bolstered scientists’ efforts to set up labs and acquire funding for their research.”

But the biggest surprise was China and Singapore, with China producing 3.2 percent more human embryonic stem cell research than other areas of molecular biology and genetics, and Singapore producing 2.6 percent more research.

“China and Singapore both showed impressive performance in human embryonic stem cell research,” said Levine. “Although these countries are very different, both have been striving to grow their biomedical research communities and it seems likely they focused on human embryonic stem cell research, in part, because they saw that traditional scientific powerhouses like the United States were moving so tentatively in this area.”

Australia had a more mixed policy and a more mixed result. While Australia does allow new stem cell lines to be created from fertility treatments, it explicitly banned the use of stem cells derived from somatic cell nuclear transfer from 2002 to 2006. Beginning in 2006 scientists were allowed to use stem cells from somatic cell nuclear transfer, but under strict regulatory guidelines. That may explain why Levine’s study found that Australia showed a more modest result of producing only 1.6 percent more human embryonic stem cell research than other areas of molecular biology and genetics.

The United States, however, is significantly under-performing in this area. Although Levine’s study found that the U.S. produced 36 percent of the research performed on human embryonic stem cells, far more than any other country, when he compared those studies to other areas of research in molecular biology and genetics, he found that the U.S. had a deficit of 10 percent.

Although the U.S. government is the funding source for 63 percent of academic research and development, federal funds can only be used for studies on a small number of stem cell lines produced before August 9, 2001. As a result, much research in this area in the U.S. is done either with state money or private money.

Given that scientists have less incentive in the private sector to publish research papers, it’s possible that Levine’s metric undercounts the amount of research done in this area in the U.S. But even so, the contribution from the U.S. is still reduced since research that isn’t published does little to increase public knowledge.

But that may change. Venturing where the federal government fears to tread, states like California, New York, Connecticut and Maryland are becoming places researchers can turn to for human embryonic stem cell funding. But Levine thinks that development may complicate matters.

“There are a variety of funding sources out there now, but it makes the field more complicated for scientists to follow the various rules set forth by the states and foundations,” said Levine. “I think scientists would prefer clear oversight from a federal government that’s supportive of their research.”

Levine plans to follow up this current work with a look at how collaboration is affected by these different state policies.

Some Early Stage Colon Cancer Patients Should Not Receive Chemotherapy, Mayo Researchers Say

mdash; Mayo Clinic researchers and collaborators say they have conclusively demonstrated that a substantial subset of colon cancer patients should not receive chemotherapy because it provides no clinical benefit, and actually may reduce survival time.

Research findings indicate that oncologists should use an existing test to check tumor subtype in certain patients before offering treatment. Patients who would benefit most from this test include those with locally advanced disease that has not spread to their lymph nodes, known as stage II disease.

The study, released May 15 as part of the 44th annual meeting of the American Society of Clinical Oncology, found that the 15 percent of patients with tumors defined as "deficient DNA mismatch repair" (dMMR) do not respond to 5-fluorouracil (5-FU) chemotherapy, which is widely used to treat colon cancer.

The researchers and collaborators published a study in 2003 in the New England Journal of Medicine (NEJM) http://www.ncbi.nlm.nih.gov/pubmed/12867608) (http://www.ncbi.nlm.nih.gov/pubmed/12867608) that suggested patients with dMMR tumors should not be treated with chemotherapy. Because the finding was so novel, confirmation of the results was required before they could be incorporated into clinical practice. This new work offers that confirmation.

"We think it is very important for patients and their doctors to have this information before considering treatment in a patient with stage II colon cancer," says Daniel Sargent, Ph.D., a Mayo Clinic biostatistician who is presenting the study results. "It could save patients the toxicity, inconvenience and expense of treatment from which they will receive no benefit."

Simple laboratory tests for dMMR exist. They are currently used to check for hereditary colon cancer that also is characterized by the absence of mismatch repair proteins, says coauthor Stephen Thibodeau, Ph.D.

"Many clinical laboratories across the country already use these tests," he says. "Now that this study proves the case that dMMR testing should be part of standard diagnostic practice for the treatment of colon cancer, this can be easily incorporated into a clinical workup."

Researchers know that colon cancer can be divided into at least two major groups. About 15 percent of tumors demonstrate the inability to correct damage to DNA by an important error-checking mechanism called DNA mismatch repair (dMMR tumors). The remaining 85 percent have different genetic alterations and exhibit another type of cellular problem called chromosomal instability.

In addition to different types of cellular problems, these two tumor groups seem to behave quite differently in patients. "It has been known for some time now that patients whose tumors have dMMR do better. The tumors are somewhat less aggressive, and they tend to occur later in life," says Dr. Sargent. "Overall, these patients have a better prognosis.

"This study is important because it looks more carefully at how these patients respond to chemotherapy," he says. "This study now provides convincing data to show that a subset of patients with dMMR tumors do not benefit from treatment. Without treatment, patients with dMMR tumors have a better prognosis compared to patients with chromosomal instability."

To ensure the original NEJM findings were reliable — a finding that could change clinical practice — the researchers spent years finding patients who had not been treated with 5-FU, and then analyzed how well these patients responded in relation to tumor subtype. "We had to develop an international collaboration, with multiple groups in the United States and Europe contributing both data and biospecimens from many different studies," says Dr. Sargent. "We felt that because our initial finding was clinically important to patients, this validation study was critical."

The research team studied tissue specimens from 1,027 patients. Sixteen percent were classified as having dMMR. The study showed that those patients whose tumors had the chromosomal instability type benefited significantly from chemotherapy. These chemotherapy-treated patients had a five-year survival of 74 percent compared to 66 percent in untreated patients.

But chemotherapy treatment did not help patients with dMMR. Researchers found that patients who had stage II disease with tumors defined as dMMR had significantly worse five-year survival (75 percent) if they were treated with standard 5-FU-based chemotherapy compared to patients who were not treated (93 percent survival).

Research is ongoing to understand why patients with dMMR tumors can have a worse prognosis after chemotherapy treatment. One theory, according to Drs. Sargent and Thibodeau, is that because these cancer cells cannot repair damage from chemotherapy, the treatment induces mutations that can cause the cancer to become more aggressive. Another theory is that while these cancers produce a strong innate immune reaction, chemotherapy may dampen that beneficial response, resulting in increased cancer growth.

Other collaborators on this study included Axel Grothey, M.D., Mayo Clinic; Silvia Marsoni, M.D., SENDO Foundation, Milano, Italy; Roberto Labianca, M.D., Opsedali Riuniti, Bergamo, Italy; Stanley Hamilton, M.D., M.D. Anderson Cancer Center, Houston; Valter Torri, M.D., Mario Negri Institute, Milano, Italy; Genevieve Monges, M.D., Institut Paoli Calmettes, Marseille, France; Christine Ribic, University of Toronto, and Steven Gallinger, M.D., Mount Sinai Hospital, Toronto, Ontario, Canada.

Cancer Patients' Quality of Life Directly Relates to Their Survival

mdash; Patients who feel better live longer, say Mayo Clinic researchers, working with the North Central Cancer Treatment Group (NCCTG), in study results released May 15 as part of the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Mayo Clinic cancer researcher and the study's lead author, Angelina Tan, says the results show quality of life is an independent factor in survival.

"Quality of life appears to affect the survival of cancer patients," says Tan. "If physicians can identify patients who are not doing well, they will be able to intervene and, we hope, improve not only their patients' sense of well-being, but also their length of life."

The researchers compared overall survival with responses from 3,704 patients to one question — "On a scale of 0 to 10, how would you rate your quality of life?" Patients had a variety of cancer types, and the question was asked during their participation in one of 24 different NCCTG clinical trials. The unifying factor for the patients was that all had late-stage disease. All results were converted to a 100-point scale.

The team found that baseline quality of life was a strong predictor of survival. They found a distinct difference when dividing patients by the median score of 83 (6.1 months increased survival time for those with scores greater than or equal to 83). The investigators also divided the group into those with scores of more than 50 and 50 or less, defining those in the 50 or less category as having clinically deficient quality of life. In this analysis, the results were even more striking, with increased survival of 7.5 months for the non-clinically deficient patients. The investigators determined that these numbers were independent of performance status (a traditionally used survival prediction method evaluating a patient's ambulatory status).

This study is one of several similar quality of life studies that are being presented by Mayo Clinic researchers at the ASCO annual meeting.

"Quality of life research is a priority at Mayo," says Jeff Sloan, Ph.D., a cancer researcher at Mayo and the study's primary investigator. "While doctors know that a patient's quality of life is important, these studies show that measuring it is necessary and can predict how patients will do."

Dr. Sloan, Tan and their colleagues at Mayo Clinic and NCCTG hope current and future research will identify both how and when clinicians can best support their patients' feelings of well-being. For example, if the quality of life deficit was identified to be related to patient fatigue and emotional distress, interventions (pharmaceutical, psychosocial, etc.) could be offered to improve patient well-being.

"If quality of life deficits can be identified routinely in clinical practice, it will help patients," says Tan. "Physicians can address the issues leading to a decrease in quality of life, and ideally these interventions will extend survival."

Other researchers included Paul Novotny; Judith Kaur, M.D.; and Jan Buckner, M.D., all from Mayo Clinic. NCCTG researchers included Paul Schaefer, M.D., Toledo Community Hospital Oncology Program, Toledo, Ohio; Philip Stella, M.D., St. Joseph Mercy Health System, Ann Arbor, Mich.; and John Kuebler, M.D., Columbus Community Clinical Oncology Program, Columbus, Ohio.

Related quality of life studies being presented at ASCO include:

Baseline quality of life is a strong prognostic factor for overall survival in patients with advanced stage non-small cell lung cancer, Schild et al.

A quality-of-life assessment of patients participating in phase I clinical trials confirms a decrease during treatment, Atherton et al.

Baseline quality of life is a strong and performance status-independent prognostic factor for overall survival in patients with metastatic colorectal cancer, Turja et al.

Tumor burden is not related to quality of life in patients with metastatic colorectal cancer, Sloan et al.

For more background information on integrating quality-of-life measures into clinical practice, read Mayo's two-part monograph published in the November–December 2005 and November–December 2006 issues of Current Problems in Cancer.

NCCTG is a national clinical research group sponsored by the National Cancer Institute. Its research and administration are based at Mayo Clinic. NCCTG consists of cancer specialists at community clinics, hospitals and medical centers in the United States, Canada and Mexico. The group is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live.

Vaccine May Double Survival in Patients with Deadly Brain Tumors

A vaccine aimed at inducing immunity to the most common and deadly type of brain tumor may stave off recurrence and more than double survival in patients, according to a new study led by researchers in Duke's Preston Robert Tisch Brain Tumor Center.

"This vaccine represents a very promising therapy for a cancer that comes out of the blue and robs people of something most of us take for granted -- time," said John Sampson, M.D., Ph.D., a neurosurgeon at Duke and lead investigator on this study. "The possibility of doubling expected survival -- with few if any side effects -- would represent a big step and a lot of hope for this group of patients."

Sampson presented the results of this Phase II study during an oral presentation at the annual American Society of Clinical Oncology meeting in Chicago on June 2, 2008. The study was funded by the National Institutes of Health and Celldex Therapeutics, a subsidiary of Avant Immunotherapeutics, which has licensed the rights to the vaccine and provided vaccine for use in the study.

The vaccine targets a protein expressed on about half of all glioblastoma multiforme (GBM) tumors. The protein, known as epithelial growth factor receptor variant III (EGFRvIII), is not expressed in normal tissues but is prevalent in GBMs, which makes it an attractive target for a vaccine, Sampson said.

The vaccine targets the protein and enhances immune response to it, killing tumor cells that express the protein and preventing the re-growth of brain tumors in patients who have already been diagnosed and treated with standard regimens including surgery, chemotherapy and radiation.

This study included 23 patients, treated at Duke and at M.D. Anderson Cancer Center. Patients had all been diagnosed with GBMs, and had been treated with standard therapy. Patients in the trial received vaccine injections monthly and were given a chemotherapeutic agent called temozolomide in conjunction with the vaccine treatments. The temozolomide is thought to enhance the immune response to the EGFRvIII, Sampson said.

"This reflected something of a surprising conclusion, because it stands to reason that chemotherapy, which suppresses the body's immune system, would make the vaccine less effective," Sampson said. "What we found was that the opposite is true. While the body is recovering from chemotherapy, immune response is actually stronger as the immune system overcompensates in order to right itself. It's the perfect time to introduce a vaccine."

Patients in the study survived without re-growth of their tumors for a median of 16.6 months, which more than doubles the usual 6.4-month expected progression-free survival in these patients.

Study patients lived for an average of 33.1 months; patients who are diagnosed with GBMs and treated with standard therapy typically live an average of 14.3 months.

"We're more than doubling survival time in this group, and we have some patients who are four, five or six years out from diagnosis, which is virtually unheard of in these people," Sampson said.

The vaccine has caused virtually no side effects; swelling at the injection site is often a patient's only complaint. A Phase III trial is now open at more than 20 sites nationwide.

Other researchers involved with this study include Gary Archer, Darell Bigner, Henry Friedman, Duane Mitchell and David Reardon of Duke; Amy Heimberger and Raymond Sawaya of M.D. Anderson Cancer Center; and Tom Davis and Tibor Keler of Celldex Therapeutics.

Banner Pharmacaps Receives FDA Approval for Amantadine Softgel Capsules

BUSINESS WIRE--Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, announces that the US Food & Drug Administration granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride USP 100 mg soft gelatin capsules on May 29, 2008.

Amantadine is indicated for the prophylaxis and treatment of signs and symptoms of infection in the respiratory tract caused by various strains of influenza A virus. Amantadine is also utilized in the treatment of Parkinson’s Disease and drug-induced extrapyramidal reactions.

Children Still Taking Dangerous OTC Medicine, Study Finds

HHH Note: We thought you'd be interested in reading this article. It appears as if some parents haven't gotten the word--- yet.

By Mark Huffman
ConsumerAffairs.com

Despite Food and Drug Administration concerns about the safety and efficacy of over-the-counter cold medicine for very young children, a new study shows it is still in widespread use.......

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CIOF Advises Caution Regarding CDC Obesity Study

/24-7PressRelease/ - Douglas Castle, Senior Advisor to The Board of Trustees of CIOF stated in an interview this morning that, "Those of us affiliated with the Children's International Obesity Foundation are inclined to advise the general public to take this seemingly "good" news with more than a modicum of caution, and to view the results with some healthy skepticism.

"The cited CDC study is quite preliminary and general in its nature, and may be subject to a variety of statistical flaws and external influences which may render the study less than indicative of reality. At CIOF, we believe that more studies must be conducted over a far greater period of time, and with tight scientific controls before any credible claim of a 'leveling off' can be made.

"But even more importantly, if the best hope that this study can offer us is that childhood obesity has leveled off to a mere one in three children, this result is wholly unacceptable.

"Education and programs must continue, as must aggressive causal and treatment research, if we love our children enough that losing one out of every three of them to complications resulting from the obesity epidemic is still a totally unacceptable reality.

"The war against overweight and obesity in children and teens must continue to be fought in all quarters, including homes, schools and our social institutions.

"Perhaps our greatest enemy is the deadly complacency that typically overcomes and dulls the populace every time any news of "stability" or "stabilizing" of any negative factor in our lives makes its way to the headlines. We foolishly drop our guard and cease our efforts prematurely out of a sense of false relief.

"At CIOF, we remain on high alert. Our work is only beginning. We do not want a mere 'leveling off' - we won't be satisfied until we have eliminated the problem."

Data Presented at ASCO Finds REVLIMID as a Monotherapy is Effective and Well-Tolerated for Previously Treated Multiple Myeloma Patients

BUSINESS WIRE--The Moffitt Cancer Center today said findings from a clinical trial presented at the American Society of Clinical Oncology (ASCO) meeting evaluating REVLIMID (lenalidomide) as a monotherapy is both effective and well-tolerated in patients who have been previously treated for multiple myeloma with two or more therapies.

In the study, 26% of relapsed refractory multiple myeloma patients treated with REVLIMID as a single achieved an overall response, either complete or partial remission, and 66% of patients experienced stable disease. The median overall survival was 1.9 years with 41% of patients alive after three years. Prior to this innovative therapy the median overall survival was less than a year. Additionally, the duration of response was 13 months.

“REVLIMID is a novel, oral, targeted immune modulator cancer therapy with impressive clinical data in both newly diagnosed and previously treated multiple myeloma that shows REVLIMID can provide durable, long-lasting results for patients,” said Dr. Mohamad Hussein, Head Multiple Myeloma Section, Moffitt Cancer Center. “This study demonstrates that REVLIMID is effective in treating patients in which other therapies have failed without complimentary steroids or chemotherapy that can potentially cause serious side effects helping patients to live longer with a better quality of life.”

Multiple myeloma is a cancer of one of the immune cells that affects production of red cells, white cells and platelets. It is the second most prevalent and fastest growing of the blood cancers, affecting an estimated 750,000 people worldwide and 60,000 patients in the U.S.

REVLIMID is the newest of what are called immune modulators which have changed the outlook for patients with multiple myeloma and enable doctors to treat the previously incurable cancer as a chronic, manageable condition. It is an oral drug that can be taken at home and doesn’t have some of the difficult side effects associated with traditional chemotherapy because it targets the cancer cells directly along with the factors that support their growth.

Health Stories of Interest

We wander around the Internet at times looking for stories we may have missed, or stories we haven't missed but written with a different twist. Here are a few from Consumer Affairs:

Consumers Union Weighs In On Drug Ads Wants ads to include 800 number to report side effects.

FDA Wants Recall of Xiadafil VIP Tabs Product contains dangerous undeclared ingredient, agency warns.

Heart Bypass Patients Fear 'Pump Head' Effect Surgery leaves some patients confused or lacking in mental sharpness.

First Vioxx Judgment Overturned On Appeal Judges find no evidence Vioxx caused defendant's heart attack.