Teen Tanning Hazards

By Carol Rados

Parents of teen-agers are strongly encouraged by public health experts and medical professionals to discuss with their kids the dangers of indoor tanning equipment, and even to discourage its use. In fact, legislators in some states are proposing to make it illegal for a teen to tan in a commercial salon without parental consent.

According to the American Cancer Society (ACS), exposure to the sun's ultraviolet (UV) rays appears to be the most important environmental factor in developing skin cancer. Consequently, the dangers from exposure to UV rays from artificial sources of light, such as tanning beds and sunlamps, are similar to the dangers of exposure to sunlight. Moreover, some experts strongly believe that the sharp rise in the rates of the most serious type of skin cancer--malignant melanoma--may be due to increased exposure to UV radiation, whether from natural sunlight or artificial sources of light.

When exposed to UV radiation, the skin begins to produce a pigment called melanin to protect itself from burning. It is the production of melanin that causes the skin to darken and produce the tan. The production of new melanin takes three to five days.

Joshua L. Fox, M.D., a dermatologist in Fresh Meadows, N.Y., says, "Continued use of a tanning bed or sunlamp can be quite dangerous, particularly during the teen-age years." Teens are at greater risk, he says, because they are still experiencing tremendous growth at the cellular level, and, like other cells in the body, the skin cells are dividing more rapidly than they do during adulthood.

W. Howard Cyr, Ph.D., and Sharon A. Miller, both laboratory leaders in the Food and Drug Administration's Center for Devices and Radiological Health, say that the agency has regulated the manufacture of sunlamp products--sunlamps, tanning beds, tanning booths, and other related equipment--since 1979. Initially, there was a widespread acute risk from sunlamp products, as indicated by a large number of skin and eye injuries treated annually in hospital emergency rooms. Federal performance standards for sunlamp products were established to protect people from acute burns and exposure to hazardous shortwave UV radiation that was unnecessary for tanning.

In 1985, the agency decided to amend the standards to make the requirements more compatible with then-current products. When sunlamp technology changed and sunlamps emitting primarily UVA radiation--longer-wave, less efficient at producing a sunburn--became prevalent, longer exposure times were allowed, Miller says.

In 1986, the FDA published a policy letter that described how the maximum timer limit should be determined and provided guidance on recommended exposure schedules. The manufacturers of sunlamp products are required to include a recommended exposure schedule in their labeling. This schedule should be clearly visible to users before they begin their exposure session.

"FDA does not recommend the use of indoor tanning equipment," Miller says. Fox agrees. "There is no such thing as a safe tan," he says. "Just one sunburn increases your risk for skin cancer."

However, Miller says that if people insist on using tanning devices, there are things they can do to reduce the potential dangers.

"Start slowly, with short exposure times, and build up to a tan. If you get the maximum exposure the first time, you will probably get burned," Miller says. And, she adds, often people don't even know they are burned until it's too late. "Remember that a sunburn doesn't usually show up until several hours after the exposure," she says. In addition, the recommended exposure schedules do not allow for tanning more frequently than every other day. After a tan is developed, tanning frequency should be reduced to no more than twice a week.

Cyr and Miller warn that, in practice, tanning salon operators control the exposure time and that they may allow the customer to exceed exposure times written on the label. This is especially true for the beginning of the tanning course when users are advised to start off with very short exposures, usually five minutes or less. Fox says that people who use these products should always ask to see the information contained in the label. Be wary, he adds, if tanning salon operators can't produce it.

Miller says that the use of FDA-compliant eyewear that blocks UV rays is absolutely essential for tanning bed users to protect their eyes from corneal burns and cataracts from long-term exposure.

A study done by researchers at Wake Forest University, published in the July 2004 issue of the Journal of the American Academy of Dermatology, found that participants thought UV exposure was not only desirable for improving appearances, but also was somewhat addictive. The study concluded that "The relaxing and reinforcing effects of UV exposure contribute to tanning behavior in frequent tanners and should be explored in greater detail."

Fox advises parents to explore safer, alternative means for their children to acquire a tan. "Teens should know about the options," he says, which include self-tanners in the form of creams and gels. "Get the look you like without the damage that can occur with tanning equipment."

New Health Initiative to Improve Cancer Treatments

Three Department of Health and Human Services agencies are working together for the first time to find biologic markers that could help improve cancer treatments.

In February 2006, the Food and Drug Administration; the National Cancer Institute (NCI), part of the National Institutes of Health (NIH); and the Centers for Medicare & Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI)--an agreement to collaborate on biomarker development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.

"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to

* assess after one or two treatments whether a patient's tumor is responding to treatment
* determine more definitively whether a tumor is dying, even if it is not shrinking
* identify which cancer patients are at high risk of their tumor coming back after therapy
* determine whether a patient's tumor is likely to respond at all to a specific treatment
* efficiently evaluate whether an investigational therapy is effective for tumor treatment.

The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.

"Almost four years ago, NIH set out to create a ‘roadmap' for 21st century medical research," says NIH Director Elias A. Zerhouni, M.D. "Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration."

Under OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to use biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as with professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.

"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," says NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."

The first OBQI project will serve to validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma to determine whether FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.

"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," says CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."

Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and will address agency priorities identified through the FDA's Critical Path and the NIH's Roadmap Initiatives.

OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between the NCI and the FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments.
The FDA's Critical Path

Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments. New tools will lead to answers about how the safety and effectiveness of medical products can be demonstrated in faster timeframes with more certainty and at lower costs. Visit www.fda.gov/oc/initiatives/criticalpath/ for more information on the FDA's Critical Path.
The NIH Roadmap

The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address. The goals include making the biggest impact possible on the progress of medical research, and catalyzing changes that will transform new scientific knowledge into tangible benefits for public health. See www.nihroadmap.nih.gov for more on the NIH Roadmap.

The Importance of Patient-Reported Outcomes ... It's All About the Patients By Linda Bren

A patient-reported outcome (PRO) is a measurement of any aspect of a patient's health status that comes directly from the patient, without the interpretation of the patient's responses by a physician or anyone else.
How Do PROs Differ From Other Measurements?

A visit to the doctor often means being poked and prodded with various instruments, such as a thermometer stuck in the mouth, a stethoscope placed on the chest, or a blood pressure cuff wrapped around an arm.

All of these instruments give the physician measurements—blood pressure, temperature, heart rate—that help in diagnosing or treating an illness.

But none of these instruments measure how much pain patients feel, how depressed they are, how well they sleep at night, or whether they have enough energy to walk up a flight of stairs. That information must come directly from the patients.

Along with getting a physical examination and lab tests, patients are routinely asked how they are feeling or how well they are functioning, says Robert Temple, M.D., director of the Food and Drug Administration's Office of Medical Policy, but the information they provide is filtered through a "knowledgeable interpreter"—the physician.

For example, a person with heart failure will be examined for large amounts of fluid in the body tissues (edema), for fluid in the lungs, and for abnormal heart sounds. He or she might get a chest X-ray or echocardiogram, and would be asked about his or her ability to exercise. The patient would be given a heart failure classification, a widely recognized four-category description of the severity of exercise limitations that makes use of nonstandardized questions and has considerable room for judgment.

In these evaluations, the patients' own assessment of their well-being has not been ignored, but their reports have been interpreted by the physician.

Increasingly, however, information about symptoms and performance is being obtained directly from patients using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function—measures that are called PROs. The questionnaires used to collect this information are called PRO instruments.

What is really new, says Temple, is that these instruments are being used to assess symptoms without the physician's interpretation. "The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels," says Temple.
Why Is the FDA Interested in PROs?

The FDA is encouraging the medical research community to use PROs in clinical trials to help tell whether a new drug or medical device is working and how well it is working. If PROs are collected, measured, and assessed properly, the information can be used by drug or device developers to support the approval of a new medical product and claims about that product.

Beyond clinical trials, researchers also are investigating how PROs can be used in clinical practice to enhance the treatment of patients.

The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined, says Laurie Burke, R.Ph., M.P.H., director of the FDA's study endpoints and label development team in the Office of New Drugs. "It's all about the patients."

"Just like a doctor may ask, ‘how are you feeling today,' but then probes with further questions, a PRO instrument probes in a structured, formal way," Burke says.

Getting information directly from patients about their symptoms and about how they feel or function is not new. More recently, many researchers have developed their own PRO measuring instruments, says Burke. "But the problem is that although those measures are familiar to the people who developed them, we often can't interpret the measures."

The FDA is working with the research community, the pharmaceutical and medical device industry, and other government agencies to ensure that the PRO instruments used are reliable, interpretable, and valid—in other words, that they measure what they are intended to measure and that they are backed up by solid, scientific rationale.
Why Use PROs?

PRO instruments offer a structured interview technique that minimizes measurement error and ensures consistency, ultimately providing a more reliable measurement than one that can be obtained by informal interviews.

PROs are useful because some treatment effects are known only to the patient, says Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products, and it is helpful to standardize the questions asked of patients. For example, pain intensity and pain relief have always been measured with PRO instruments. "In most cases, the only way to know if someone is feeling better is to ask how much pain they are in," he says.
PROs and Quality of Life

PRO measurements are sometimes confused with quality of life measurements. Quality of life is a broad concept referring to all aspects of a person's well-being. PRO instruments are used to measure quality of life, but they also can focus much more narrowly—for example, on a single symptom, such as pain.

Some manufacturers of drugs or medical devices are interested in showing, and claiming, that a treatment improves patients' quality of life. Such a claim would imply an evaluation of the impact of a treatment on all aspects of a person's well-being. Quality of life measurements assess not just the physical consequences of disease, such as symptoms and decreased function, but also the effect of disease on a person's emotional state, feelings, coping behaviors, and self-identity (psychological functioning) and on a person's ability to interact well with others (social functioning).

Despite the interest in examining effects of drugs on quality of life, the FDA has rarely allowed a claim that a product improves quality of life because it has been very difficult to show such broad effects from drugs that are directed at specific symptoms.

But a health-related quality of life (HRQOL) claim would be considered by the FDA if the PRO instrument reliably captured the impact of treatment on the most important aspects of HRQOL. HRQOL represents an individual's perceptions of how an illness and its treatment affect, at a minimum, the physical, mental, and social aspects of his or her life.

HRQOL PRO instruments have been developed for specific diseases, and the FDA has permitted HRQOL claims on the label of certain drugs. For example, the label of the asthma drug Advair, an FDA-approved inhaled bronchodilator, is allowed to carry an HRQOL claim because, says Burke, "the drug sponsor successfully measured an impact of Advair on not only the symptoms of asthma but also on physical, social, and psychological functioning in asthma patients." The Advair label states, in part:

The subjective impact of asthma on patients' perception of health was evaluated through use of an instrument called the Asthma Quality of Life Questionnaire (AQLQ). Patients receiving Advair … had clinically meaningful improvements in overall asthma-specific quality of life ...
Drug Approvals Based on PROs

From 1997-2002, 30 percent of the new drugs approved by the FDA contained PROs in their labels. Many drugs approved more recently also have shown effectiveness based on PROs.

In the past decade, the FDA has approved six cancer drugs based, at least in part, on PRO instruments which showed that the drugs improved functioning or relieved symptoms, such as pain, difficulty swallowing, or dry mouth. Five of these drugs also showed evidence of attacking the cancer itself. The sixth, Novantrone (mitoxantrone), was approved based primarily on pain relief using a PRO instrument called a pain intensity scale, says Edwin Rock, M.D., Ph.D., a cancer specialist in the FDA's Office of Oncology Drug Products.
Types of PRO Instruments

Many different types of PRO instruments are used. One of the most common instruments for measuring pain requires the patient to verbally rate the level of perceived pain intensity using, for example, adjectives such as none, mild, moderate, and severe, or numbers from 0 to 10, with 0 representing no pain and with 10 representing the worst possible pain.

PROs can also be used in children, says Rappaport, but different scales are used, such as pictures of faces. "The series of faces start on the left with smiley and happy faces, there's a bland expression on the face in the middle, and on the right side are frowns and sad faces."
FDA Guidance

The FDA published draft guidance in February 2006 that tells researchers how the agency intends to evaluate PRO instruments. The guidance, called PRO Measures: Use in Medical Product Development to Support Claims, also describes how sponsors of new drugs or devices can use study results measured by PRO instruments to support claims in the labels or the advertising of approved products.

In February 2006, the FDA and the Mayo Clinic College of Medicine jointly sponsored a symposium in Chantilly, Va., to discuss the draft guidance and to help researchers gain an understanding of how to incorporate PROs into clinical trials. Regulatory personnel, scientific researchers, pharmaceutical industry representatives, patient advocates, and consumers participated in the meeting and were encouraged to submit comments on the guidance. The FDA is considering the comments in its forthcoming final guidance.
Better PRO Measures

According to National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., "There is a pressing need to better quantify clinically important symptoms and outcomes that are now difficult to measure."
A group of scientists from seven university medical schools and the NIH formed a cooperative network in 2004 to address this need. Through participation in a five-year initiative called the Patient-Reported Outcomes Measurement Information System (PROMIS), they are working to develop better ways to measure patient-reported symptoms, such as pain and fatigue, and aspects of HRQOL across a variety of chronic diseases and conditions including cancer, asthma, multiple sclerosis, arthritis, and heart disease. A goal of PROMIS is to develop a set of publicly available PRO instruments and measures that researchers anywhere in the world can access from the Internet.

"Our first goal is to develop PRO measurement tools for clinical research purposes," says Bryce Reeve, Ph.D., a psychometrician and program director for outcomes research at the National Cancer Institute. "But clinical practice can also benefit from our PRO tools."
Beyond Clinical Trials

The phone rings, and a patient picks it up and hears a voice say, "It's time for your health check. Would you like to take a few minutes now to answer some questions, or shall we remind you later?" The patient speaks into the phone when prompted, hangs up when done, and doesn't think much more about it—until a call comes in from a medical clinic. "I see your pain is more severe than it was last week," says a nurse, "and the doctor would like to adjust your medication."

This scenario may already be playing out in some clinics, says Reeve, but he envisions that in the future, PRO instruments will be used more with interactive systems to monitor health and to guide treatment recommendations, especially in people who require long-term care, such as cancer patients.

"Reminders can be sent by e-mail or phone," says Reeve. Or when patients go in for a medical appointment, they can be given a laptop computer to respond to a brief questionnaire while they're waiting to see the doctor, he adds. "Or they can answer the questions from home before going to the doctor's office and the information could be available by the time they arrive at their appointment."

The responses would be sent to the doctor's office electronically and linked to a person's electronic medical record. The computer would generate a one-page status report for the physician that summarizes the patient-reported data, flagging any significant symptom changes, such as worsening of pain, says Reeve.

Reeve sees these technological advances as a way to enhance doctor-patient communications and decision-making. "Doctors obviously are very short on time," he says. "Combining PROs with technology will help them perform a comprehensive assessment of their patient. It also empowers the patient to be actively involved in their treatment and well-being."

This article has been condensed from the original article as it appears in FDA Consumer magazine and edited for the FDA Web site. The print version of FDA Consumer is available by subscription.

Take Time for a Mammogram

By Linda Bren

If you're a woman over 40 and you can't remember the last time you had a mammogram, you may be overdue.

The National Cancer Institute (NCI) estimates that 1 in 8 women will be diagnosed with breast cancer at some time in their lives. But the good news is that mammograms--X-ray pictures of the breast--can detect breast cancer early, when it's most treatable.

According to the Centers for Disease Control and Prevention (CDC), a mammogram can show a lump in the breast an average of one to three years earlier than a woman can feel it.

"Mammograms are our best tool for early detection," says Marsha Henderson, Health Programs Director in the Food and Drug Administration's Office of Women's Health. "Early detection gives a woman more treatment options and a better chance of successful treatment and survival."

In short, a mammogram can save your life.

How Often?

The NCI recommends that women in their 40s and older have mammograms every one to two years. Some women who are at higher-than-average risk of breast cancer may need to get them at a younger age and more often. Talk to your doctor about when you should get a mammogram.

Safety and Quality of Mammograms

A federal law, the Mammography Quality Standards Act (MQSA), ensures that mammography is safe and reliable. Under the MQSA, all mammography personnel and facilities, including mobile units, in the United States must be accredited, be FDA-certified, and pass annual inspections. Mammography facilities are required to display their FDA certificate where patients can see it. The certificate indicates that the facilities have met stringent standards and can provide quality mammography.

In addition, the law requires all mammography facilities to

• Provide patients with an easy-to-understand report on the results of their mammogram
• Provide a way for consumers to voice a complaint and a process for addressing their concerns
• Give patients their original mammograms when they are needed. A patient needs her original mammograms if she decides to change mammography facilities or makes an appointment for a second opinion or with a specialist for treatment.

Just Do It

Some women just don't take the time to go get a mammogram, says Cheryl Kidd, M.P.H., Director of Education for the Susan G. Komen Breast Cancer Foundation. Or they give other reasons for not going. Here are some common reasons they may avoid mammograms.

It hurts. Some women experience pain during a mammogram. "It can be painful, but it only hurts for a few seconds," says Kidd. In order to have a good sharp image, the technologist has to compress the breast between two plates.

"And if it really hurts, tell the technologist," says Henderson. "She may be able to reposition the breast so it's more comfortable."

Women with sensitive breasts may want to schedule a mammogram one week after their period, when the breasts are usually the least tender.

I'm too old to get breast cancer. "This is a big myth," says Henderson. "Some women think as they get older, they don't need to go as often." But the older you are, the greater your chances of getting breast cancer, according to the NCI.

I can't remember to go. "Go around a time that's easy to remember," advises Kidd. "Like the month of your birthday." Or get it around the time of your annual checkup or Pap smear.

I'm afraid that the radiation can harm me. A federal law has established a maximum radiation dose limit that is very low and considered to be safe. And there have been such improvements in mammography that women receive 50 times less radiation than they received 20 years ago, says the FDA.

According to the American Cancer Society, one mammogram exposes a woman to roughly the same amount of radiation as flying from New York to California on a commercial jet.

It makes me nervous. It can be scary, says Kidd. "If you're afraid, take a friend or family member with you."

"You can make it an event," adds Kidd, who says she knows of families that schedule appointments around Mother's Day, and mothers, daughters, and aunts all go together.

After the mammogram, the technologist usually asks women to wait in the changing stall in case more pictures are needed. "This is when some women panic," says Henderson. "But you shouldn't be nervous." Even if the technologist wants to take more pictures, it doesn't mean something is wrong. It is usually just to get an additional view to get a clearer picture of a particular area.

I'm scared I'll have breast cancer. It's possible that you'll get some bad news, says Kidd. But most lumps are not cancerous. And if you do have breast cancer, treatment is more successful when caught early. Deaths from breast cancer have been steadily dropping since 1990, due to early detection with mammography and advances in treatment.

"You may be scared, but not knowing is worse," says Kidd. Finding cancer early makes it easier to treat, often without losing a breast.

It costs too much. Medicare and many private insurers provide coverage for screening mammograms.

The CDC coordinates the National Breast and Cervical Cancer Early Detection Program, which provides screening mammograms at low or no cost to women throughout the country who qualify based on income.

How to Get a Mammogram

• Ask your doctor or nurse to help you find an FDA-certified mammography facility. See www.fda.gov/cdrh/mammography/certified.html for a list.
• Call the facility to make an appointment.
• If you have breast implants, ask the facility before scheduling the mammogram whether their personnel are trained in X-raying women with implants. If not, ask to be referred to another facility. At the time of the mammogram, remind the technologist before the procedure is done that you have implants.
• When you go to the facility, look for the FDA certificate and make sure it has not expired.
• Do not wear deodorant, lotion, powder, or perfume the day of the mammogram. They can cause shadows on the X-ray pictures and can make them harder to read.
• Take your doctor's name and address with you so the facility can send the results to him or her. Under law, the facility must also provide the results to the patient within 30 days after the exam.
• If you do not receive the results within 30 days, call the facility or your doctor and ask for the results. Do not assume the mammogram is normal if you do not receive the results.
• If you are satisfied with the facility, go back to it every time you get a mammogram so that your X-rays can be compared from year to year.

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Risk of Breast Cancer in American Women

The older a woman is, the greater her chance of developing breast cancer. A woman's chance of being diagnosed with breast cancer is:

Ages 20 to 30 .............. 1 in 2,000

Ages 30 to 39 .............. 1 in 229

Ages 40 to 49 .............. 1 in 68

Ages 50 to 59 .............. 1 in 37

Ages 60 to 69 .............. 1 in 26

Ages 70 to 79 .............. 1 in 24

Lifetime ...................... 1 in 8

National Cancer Institute

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For More Information

National Cancer Institute
"Understanding Breast Changes: A Health Guide for All Women" and other information
(800) 4-CANCER (422-6237)
TTY/TTD: (800) 332-8615

Centers for Disease Control and Prevention
Free or Low-Cost Mammograms

American Cancer Society
(800) ACS-2345 (227-2345)
TTY: (866) 228-4327

Susan G. Komen Breast Cancer Foundation
(800) I'M-AWARE (462-9273)

FDA-Certified Mammography Facilities

New Health Initiative to Improve Cancer Treatments

Three Department of Health and Human Services agencies are working together for the first time to find biologic markers that could help improve cancer treatments.

In February 2006, the Food and Drug Administration; the National Cancer Institute (NCI), part of the National Institutes of Health (NIH); and the Centers for Medicare & Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI)--an agreement to collaborate on biomarker development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.

"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to

• assess after one or two treatments whether a patient's tumor is responding to treatment
• determine more definitively whether a tumor is dying, even if it is not shrinking
• identify which cancer patients are at high risk of their tumor coming back after therapy
• determine whether a patient's tumor is likely to respond at all to a specific treatment
• efficiently evaluate whether an investigational therapy is effective for tumor treatment.

The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.

"Almost four years ago, NIH set out to create a ‘roadmap' for 21st century medical research," says NIH Director Elias A. Zerhouni, M.D. "Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration."

Under OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to use biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as with professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.

"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," says NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."

The first OBQI project will serve to validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma to determine whether FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.

"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," says CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."

Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and will address agency priorities identified through the FDA's Critical Path and the NIH's Roadmap Initiatives.

OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between the NCI and the FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments.

---

The FDA's Critical Path

Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments. New tools will lead to answers about how the safety and effectiveness of medical products can be demonstrated in faster timeframes with more certainty and at lower costs. Visit www.fda.gov/oc/initiatives/criticalpath/ for more information on the FDA's Critical Path.

---

The NIH Roadmap

The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address. The goals include making the biggest impact possible on the progress of medical research, and catalyzing changes that will transform new scientific knowledge into tangible benefits for public health. See www.nihroadmap.nih.gov for more on the NIH Roadmap.

The Importance of Patient-Reported Outcomes ... It's All About the Patients

• How Do PROs Differ From Other Measurements?
• Why Is the FDA Interested in PROs?
• Why Use PROs?
• PROs and Quality of Life
• Drug Approvals Based on PROs
• Types of PRO Instruments
• FDA Guidance
• Better PRO Measures
• Beyond Clinical Trials

By Linda Bren

A patient-reported outcome (PRO) is a measurement of any aspect of a patient's health status that comes directly from the patient, without the interpretation of the patient's responses by a physician or anyone else.

How Do PROs Differ From Other Measurements?

A visit to the doctor often means being poked and prodded with various instruments, such as a thermometer stuck in the mouth, a stethoscope placed on the chest, or a blood pressure cuff wrapped around an arm.

All of these instruments give the physician measurements—blood pressure, temperature, heart rate—that help in diagnosing or treating an illness.

But none of these instruments measure how much pain patients feel, how depressed they are, how well they sleep at night, or whether they have enough energy to walk up a flight of stairs. That information must come directly from the patients.

Along with getting a physical examination and lab tests, patients are routinely asked how they are feeling or how well they are functioning, says Robert Temple, M.D., director of the Food and Drug Administration's Office of Medical Policy, but the information they provide is filtered through a "knowledgeable interpreter"—the physician.

For example, a person with heart failure will be examined for large amounts of fluid in the body tissues (edema), for fluid in the lungs, and for abnormal heart sounds. He or she might get a chest X-ray or echocardiogram, and would be asked about his or her ability to exercise. The patient would be given a heart failure classification, a widely recognized four-category description of the severity of exercise limitations that makes use of nonstandardized questions and has considerable room for judgment.

In these evaluations, the patients' own assessment of their well-being has not been ignored, but their reports have been interpreted by the physician.

Increasingly, however, information about symptoms and performance is being obtained directly from patients using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function—measures that are called PROs. The questionnaires used to collect this information are called PRO instruments.

What is really new, says Temple, is that these instruments are being used to assess symptoms without the physician's interpretation. "The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels," says Temple.

Why Is the FDA Interested in PROs?

The FDA is encouraging the medical research community to use PROs in clinical trials to help tell whether a new drug or medical device is working and how well it is working. If PROs are collected, measured, and assessed properly, the information can be used by drug or device developers to support the approval of a new medical product and claims about that product.

Beyond clinical trials, researchers also are investigating how PROs can be used in clinical practice to enhance the treatment of patients.

The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined, says Laurie Burke, R.Ph., M.P.H., director of the FDA's study endpoints and label development team in the Office of New Drugs. "It's all about the patients."

"Just like a doctor may ask, ‘how are you feeling today,' but then probes with further questions, a PRO instrument probes in a structured, formal way," Burke says.

Getting information directly from patients about their symptoms and about how they feel or function is not new. More recently, many researchers have developed their own PRO measuring instruments, says Burke. "But the problem is that although those measures are familiar to the people who developed them, we often can't interpret the measures."

The FDA is working with the research community, the pharmaceutical and medical device industry, and other government agencies to ensure that the PRO instruments used are reliable, interpretable, and valid—in other words, that they measure what they are intended to measure and that they are backed up by solid, scientific rationale.

Why Use PROs?

PRO instruments offer a structured interview technique that minimizes measurement error and ensures consistency, ultimately providing a more reliable measurement than one that can be obtained by informal interviews.

PROs are useful because some treatment effects are known only to the patient, says Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products, and it is helpful to standardize the questions asked of patients. For example, pain intensity and pain relief have always been measured with PRO instruments. "In most cases, the only way to know if someone is feeling better is to ask how much pain they are in," he says.

PROs and Quality of Life

PRO measurements are sometimes confused with quality of life measurements. Quality of life is a broad concept referring to all aspects of a person's well-being. PRO instruments are used to measure quality of life, but they also can focus much more narrowly—for example, on a single symptom, such as pain.

Some manufacturers of drugs or medical devices are interested in showing, and claiming, that a treatment improves patients' quality of life. Such a claim would imply an evaluation of the impact of a treatment on all aspects of a person's well-being. Quality of life measurements assess not just the physical consequences of disease, such as symptoms and decreased function, but also the effect of disease on a person's emotional state, feelings, coping behaviors, and self-identity (psychological functioning) and on a person's ability to interact well with others (social functioning).

Despite the interest in examining effects of drugs on quality of life, the FDA has rarely allowed a claim that a product improves quality of life because it has been very difficult to show such broad effects from drugs that are directed at specific symptoms.

But a health-related quality of life (HRQOL) claim would be considered by the FDA if the PRO instrument reliably captured the impact of treatment on the most important aspects of HRQOL. HRQOL represents an individual's perceptions of how an illness and its treatment affect, at a minimum, the physical, mental, and social aspects of his or her life.

HRQOL PRO instruments have been developed for specific diseases, and the FDA has permitted HRQOL claims on the label of certain drugs. For example, the label of the asthma drug Advair, an FDA-approved inhaled bronchodilator, is allowed to carry an HRQOL claim because, says Burke, "the drug sponsor successfully measured an impact of Advair on not only the symptoms of asthma but also on physical, social, and psychological functioning in asthma patients." The Advair label states, in part:

The subjective impact of asthma on patients' perception of health was evaluated through use of an instrument called the Asthma Quality of Life Questionnaire (AQLQ). Patients receiving Advair … had clinically meaningful improvements in overall asthma-specific quality of life ...

Drug Approvals Based on PROs

From 1997-2002, 30 percent of the new drugs approved by the FDA contained PROs in their labels. Many drugs approved more recently also have shown effectiveness based on PROs.

In the past decade, the FDA has approved six cancer drugs based, at least in part, on PRO instruments which showed that the drugs improved functioning or relieved symptoms, such as pain, difficulty swallowing, or dry mouth. Five of these drugs also showed evidence of attacking the cancer itself. The sixth, Novantrone (mitoxantrone), was approved based primarily on pain relief using a PRO instrument called a pain intensity scale, says Edwin Rock, M.D., Ph.D., a cancer specialist in the FDA's Office of Oncology Drug Products.

Types of PRO Instruments

Many different types of PRO instruments are used. One of the most common instruments for measuring pain requires the patient to verbally rate the level of perceived pain intensity using, for example, adjectives such as none, mild, moderate, and severe, or numbers from 0 to 10, with 0 representing no pain and with 10 representing the worst possible pain.

PROs can also be used in children, says Rappaport, but different scales are used, such as pictures of faces. "The series of faces start on the left with smiley and happy faces, there's a bland expression on the face in the middle, and on the right side are frowns and sad faces."

FDA Guidance

The FDA published draft guidance in February 2006 that tells researchers how the agency intends to evaluate PRO instruments. The guidance, called PRO Measures: Use in Medical Product Development to Support Claims, also describes how sponsors of new drugs or devices can use study results measured by PRO instruments to support claims in the labels or the advertising of approved products.

In February 2006, the FDA and the Mayo Clinic College of Medicine jointly sponsored a symposium in Chantilly, Va., to discuss the draft guidance and to help researchers gain an understanding of how to incorporate PROs into clinical trials. Regulatory personnel, scientific researchers, pharmaceutical industry representatives, patient advocates, and consumers participated in the meeting and were encouraged to submit comments on the guidance. The FDA is considering the comments in its forthcoming final guidance.

Better PRO Measures

According to National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., "There is a pressing need to better quantify clinically important symptoms and outcomes that are now difficult to measure."
A group of scientists from seven university medical schools and the NIH formed a cooperative network in 2004 to address this need. Through participation in a five-year initiative called the Patient-Reported Outcomes Measurement Information System (PROMIS), they are working to develop better ways to measure patient-reported symptoms, such as pain and fatigue, and aspects of HRQOL across a variety of chronic diseases and conditions including cancer, asthma, multiple sclerosis, arthritis, and heart disease. A goal of PROMIS is to develop a set of publicly available PRO instruments and measures that researchers anywhere in the world can access from the Internet.

"Our first goal is to develop PRO measurement tools for clinical research purposes," says Bryce Reeve, Ph.D., a psychometrician and program director for outcomes research at the National Cancer Institute. "But clinical practice can also benefit from our PRO tools."

Beyond Clinical Trials

The phone rings, and a patient picks it up and hears a voice say, "It's time for your health check. Would you like to take a few minutes now to answer some questions, or shall we remind you later?" The patient speaks into the phone when prompted, hangs up when done, and doesn't think much more about it—until a call comes in from a medical clinic. "I see your pain is more severe than it was last week," says a nurse, "and the doctor would like to adjust your medication."

This scenario may already be playing out in some clinics, says Reeve, but he envisions that in the future, PRO instruments will be used more with interactive systems to monitor health and to guide treatment recommendations, especially in people who require long-term care, such as cancer patients.

"Reminders can be sent by e-mail or phone," says Reeve. Or when patients go in for a medical appointment, they can be given a laptop computer to respond to a brief questionnaire while they're waiting to see the doctor, he adds. "Or they can answer the questions from home before going to the doctor's office and the information could be available by the time they arrive at their appointment."

The responses would be sent to the doctor's office electronically and linked to a person's electronic medical record. The computer would generate a one-page status report for the physician that summarizes the patient-reported data, flagging any significant symptom changes, such as worsening of pain, says Reeve.

Reeve sees these technological advances as a way to enhance doctor-patient communications and decision-making. "Doctors obviously are very short on time," he says. "Combining PROs with technology will help them perform a comprehensive assessment of their patient. It also empowers the patient to be actively involved in their treatment and well-being."

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This article has been condensed from the original article as it appears in FDA Consumer magazine and edited for the FDA Web site. The print version of FDA Consumer is available by subscription.

THE GANODERMA TREATMENT

THE GANODERMA TREATMENT--------------------------------------------------------------------------------Ganoderma, a rare variety of Mushroom, is indeed a subject of much research from ancient china of 100 B.C. or earlier to the modern times by various universities and research organizations .It is credited with the highest medicinal qualities by Chinese.It is also known as Linghzi in China. It is said that in ancient times anyone who found the rare Linghzi never revealed where and kept it a secret of health, longevity and wealth.The Japanese revered the herb as کGod's Herb"™ where it is known as Reishi. Lingzhi was considered in medicine so auspicious that it's medical efficacy has been attested to in the oldest Chinese medical text (over 2,000 years old), "The Lexicon", which is known in Japan as "Shinnoh Honsohkyo", and is now accepted as being the original textbook of Oriental medical science.In it, 365 kinds of medicines are classified and explained. Ganoderma is classified as a "Superior Herbs" or "God's Herbs" and they are for perpetual youth and longevity. This encyclopaedia states that for "superior" medicines, any amount can be taken as desired on a continuous basis with no unfavourable effects. Of the superior medicines listed in the text, Lingzhi was rated number one.Centuries ago, Lingzhi was said to be an elixir which would grant you eternal youth and longevity. It gained its ranking in the Chinese text not because of its symbolism as a good omen but because of its medicinal properties. The Linghzi Mushrooms grows only on old tree barks with certain conditions difficult to replicate. Till 1971 the mushroom was so rare that it was hardly sited except in certain mountainous areas. Many researchers had attempted to grow Ganoderma artificially but failed. Then in 1971 organised by Naoi Department of Agriculture and Professor Zenzaburo Kasai, the Kyoto University made a breakthrough in its cultivation.But now, after 2,000 years, Lingzhi has come into the spotlight as a specific remedy for cancer. This flies in the face of those in the modern medical profession who discounted the herbal remedies and oriental medicine as being as being "Myth" and "psycho-somatic"! The families of many cancer patients who have received a diagnostic "death sentence" now see Lingzhi or Reishi as the right way forward. Some are indignant that knowledge of it was withheld from them by the drug companies! Presently only 10 countries grow the herb. The demand far outstrips supply due to the increasing evidence through various researches on its efficacy in treating many disease including Cancer, HIV, Hepatitis, Diabetes, Liver disorders and mainly as a preventive due its rich anti oxidant and detoxifying qualities.Some of the research in Japan indicates strictly speaking those expressly berate taken Ganoderma for over a year the visit to doctors dropped follow half. There is thousands of research paper available including on the internet on the subject of the healing breakthroughs achieved by Ganoderma in various treatments and too lengthy to discuss here. Many of the currently available anti-cancer agents are derived form natural products, for instance paclitaxel (Taxol), and camptothecin (Hycamtin) amongst many others.In 2000 Professor Gordon McVie, Director-General of the Cancer Research Campaign (now Cancer Research UK) and Professor John Smith of University of Strathclyde met in Glasgow to discuss the role of medicinal mushrooms in the treatment of cancer. The CRC had become aware that these natural products were being used extensively in the Far East as nutriceuticals (dietary supplements) and as a source for the generation of pharmaceutical-grade medicines to treat a wide variety of diseases, including cancer.The substantial range of medicinal mushroom species from which different bioactive compounds can be derived suggested that the humble mushroom could be a source of novel anti-cancer agentsSummarized from these reports, it is found specially Lingzhi has the following properties and Improves cholesterosis, coronary insufficiency. Improves hyper and hypotensions. Improves nervous tension, neurosis. Improves chronic bronchitis, hepatitis. Improves leukocytopenia and reticuloendothelial system. The three main killers these days are: Cancer, Stroke and Coronary diseases. The latter two have their foundation closely linked to the blood circulatory system. Related problems like stroke, heart block, arteriosclerosis, obesity etc. are all tied to problems in the blood circulation. One out of three persons dies occasionally one of the above ailments everyday. Lingzhi can correct this imbalance and strengthen the system to prevent further deterioration. What are noteworthy are its preventive capabilities. For the 21st century man, stressed out, poisoned by the polluted atmosphere, bad food habits and drug induced illnesses of the today medicine. While current medicine has been very effective in treating certain conditions effectively and immediately, they do not address the holistic medicine approach of the ancient medicine as a preventive and for regeneration of wasted tissues and overwhelmed cells. Ganoderma has been proven to exert significant effect on beating pain, fortifying the body's immune system and prolonging life. Even though its role in cancer cure has not been determined 100 percent …………yet. Ganoderma has a history of 3,000 years, during which it is widely used by many people with no reported unfavourable side effects. It is therefore highly recommend for prevention. Hopefully, with so much research and emerging evidence, Ganoderma can bring a brighter outlook to everybody. Frank Duffy,
About the Author
Frank Duffy, mailto:frank3du@gmail.com The “Beat Cancer Man” Author’s URL: http://www.newinformationplace.com/ Frank Duffy is a retired managerial professional, and author of “How I Fought Cancer and Won!” He writes regular articles on the subject and is always on the look out for ways to help cancer sufferers and their families.

Prostate Cancer Clinical Test and Statistics

Larger-volume tumors of the prostate are common among older men. Available tests for the early detection of cancer have limited specificity, which necessitates a relatively high biopsy rate. The positive predictive value of combined digital rectal examination and PSA measurement has been defined, but the negative predictive value is less clear. Measurement of PSA is the most sensitive noninvasive test for prostate cancer. However, digital rectal examination detects cancer that would otherwise be missed by PSA measurement.Clinical trials serve as one way of finding prostate cancer cures. All prostate cancer medications must take pass the three phases required to gain approval from the Food and Drug Administration.Phase I of the clinical trials test the safety of a new drug. The second clinical phase is designed to determine how the proposed new prostate cancer treatment works. Patients are given the drug in high doses during this phase. The patients are watched to see what effect the test drug has on their prostate cancer. The final phase of clinical trial testing pits test medications against standard treatments. A control group is given dosages of the test drug while a second group uses standard methods of medicine-with the effects documented The purpose of the trial is to test the safety and effectiveness of the technique, called high intensity focused ultrasound (HIFU), as the initial treatment in men with newly-diagnosed, localized prostate cancer.Undiagnosed prostate cancer is highly prevalent, especially among older men [42-49]. Although many of these cancers may be considered incidental, evidence suggests that consideration of screening is warranted because earlier diagnosis of clinically significant cancers often has the potential to improve outcome [10, 12]. In fact, prostate cancer is so common among older men that selecting subpopulations for screening on the basis of risk factors other than age, such as race or family history, would not be necessary if screening and treatment strategies that favorably affect outcome were available.However, evidence also indicates that available tests for early detection have limited specificity, particularly among older men who have benign prostatic hyperplasia. Therefore, the combined use of digital rectal examination and the currently available assays for PSA results in as many as 15% of men in their 50s and 40% of men in their 70s requiring further invasive evaluation with biopsy. Positive predictive values are 15% to 21%, depending on age.Prostate Cancer Statistics:Prostate cancer is the most common type of cancer found in American men, other than skin cancer. Prostate cancer is the second leading cause of cancer death in men, exceeded only by lung cancer. Although men of any age can get prostate cancer, it is found most often in men over 50. In fact, more than 70% of all prostate cancers are diagnosed in men over the age of 65. Prostate cancer is about twice as common among African-American men as it is among white American men. It is also most common in North America and northwestern Europe. It is less common in Asia, Africa, and South America.Prostate cancer is diagnosed every 2- 3/4 minutes, approximately 190,000 new cases each year. It is the most commonly diagnosed cancer in America among men. More than 30,000 American men lose their lives to prostate cancer each year, one death every twenty minutes. Prostate cancer incidence rates increased 192% between 1973 and 1992. One in six American men is at lifetime risk of prostate cancer. If a close relative has prostate cancer, a man's risk of the disease more than doubles. With two relatives, his risk increases fivefold. With three close relatives, his risk is about 97%.African American men have the highest prostate cancer incidence and mortality rates in the world. The incidence rate is about 35% - 50% higher than - and mortality rate double - that of Caucasian males, who have the second highest rate. In the next 24 hours, prostate cancer will claim the lives of over 80 American men. Prostate cancer represents 30% of all new cancer cases in American men. This year, more cases of prostate cancer in men under the age of 65 are expected than the combined number of men of ages who are victims of leukemia, Hodgkin's disease, and brain tumors. Prostate cancer accounts for approximately 15% of all cancer cases in the United States and 15% of male cancer deaths. Yet, on average, only about 5% of federal cancer research dollars have been devoted to beat the disease.
About the Author
We at IMED LAB (Integrate Medical Laboratory) are in the business of research and distribution of drugs and natural supplements. Primarily our research and distribution is focus on men’s health care. Our line of products and research has been featured and tested in The Royal Perth Hospital Australia, Journal of Ethno-pharmacology, Pharmaceutical Technology Utrecht, Holland and National University Singapore. Website: http://www.cure-prostate

mesothelioma lawyers-usa

At the turn of the last century, asbestos was considered an ideal material for use in the construction industry. It was known to be an excellent fire retardant, to have high electrical resistivity, and was inexpensive and easy to use.The problem with asbestos arises when the fibers become airborne and are inhaled. Because of the size of the fibers, the lungs cannot expel them. They are also sharp and penetrate tissues.Health problems attributed to asbestos include1. Asbestosis - A lung disease first found in naval shipyard workers, asbestosis is a scarring of the lung tissue from an acid produced by the body's attempt to dissolve the fibers. The scarring may eventually become so severe that the lungs can no longer function. The latency period ( meaning the time it takes for the disease to develop) is often 10-20 years.2. Mesothelioma - A cancer of the mesothelial lining of the lungs and the chest cavity, the peritoneum (abdominal cavity) or the pericardium (a sac surrounding the heart). Unlike lung cancer, mesothelioma has no association with smoking.The only known cause is from exposure to asbestos or similar fibers. The latency period for mesothelioma may be 20-50 years. The prognosis for mesothelioma is grim, with most patients dying within 12 months of diagnosis.3. Cancer - Cancer of the lung, gastrointestinal tract, kidney and larynx have been linked to asbestos. The latency period for cancer is often 15-30 years.
About the Author
At the turn of the last century, asbestos was considered an ideal material for use in the construction industry. It was known to be an excellent fire retardant, to have high electrical resistivity, and was inexpensive and easy to use. The problem with asbestos arises when the fibers become airborne and are inhaled. Because of the size of the fibers, the lungs cannot expel them. They are also sharp and penetrate tissues. Health problems

Four Inflammatory Breast Cancer Signs & Six FAQs

Nearly 200,000 women are diagnosed with breast cancer each year and over 40,000 will die from it. There are seven different types of breast cancer, some more severe and with a lower survival rate than others. One breast cancer type called inflammatory breast cancer, or IBC, is a unique and aggressive kind that is rare, accounts for 1 - 5% of all cases, but deadly. It is one of the only breast cancer types that have no lumps, which makes it one of the most undetectable and scariest.There are four breast cancer signs that could mean you have inflammatory breast cancer:o Skin around the breast is hot to the toucho Breasts are asymmetrical and were not beforeo The skin becomes red or pinko There is discharge from the nipplesBelow are six frequently asked questions about inflammatory breast cancer. What should you do if you if you have these symptoms?If any of these signs persist for more than a week, speak to a physician. What is the median age affected?Women 45 – 55 are more susceptible to this specific type of breast cancer. How do you identify inflammatory breast cancer?Through surgical biopsy; IBC cannot be identified through Mammogram, Ultrasound, Magnetic Resonance Imaging (MRI), or Core biopsy.What is the survival rate?IBC has a 40% survival rate over a five year period. Many times the surgeon may remove the breast too early and cause a reoccurrence.How is Inflammatory Breast Cancer Treated?Chemotherapy before surgery, as well as drugs such as trastuzumab and lapatinib.
About the Author
BOILERPLATE: If you know of anyone or you yourself are being faced with the signs of inflammatory breast cancer, see a physician as soon as possible. If you have already been diagnosed seek out support through the MyNBCF breast cancer message boards.

Cancer – The challenges in the Treatment

Cancer is one of the diseases for which we cannot find a complete cure. A population of cells with abnormal growth characterizes cancer. These abnormal cells invade and destroy adjacent tissues, and may spread to other organs. The main cause for all types of cancers is the presence of abnormalities in the genetic material of the transformed cells.Treatment Types: There are regular treatment methods and also alternate treatment methods for cancer.The Regular Treatments: Cancer can be treated by surgery, chemotherapy, radiation therapy, immunotherapy and many others methods depends upon the areas of the body and grade of the tumor and the stage of the disease, as well as the general state of the patient. These treatments take lot of effort from the patient, very expensive and have many side effects. The most common treatments for cancer are surgery, chemotherapy, and radiation therapy. These treatments have some limitations as no treatment is completely successful in every single case.· Surgery can be very successful in treating some kinds of cancer, but it is not an option for all people. Surgery may not be possible if the cancer has spread to other areas of the body or if the tumor cannot be removed without damaging vital organs, such as the liver or brain.· Chemotherapy is the other method usually used when the cancer has spread to other areas in the body. The side effects of Chemotherapy are very severe. The patients have to take medicines on a long run basis to reduce the side effects of chemotherapy.· Radiotherapy uses radiation in the form of a special kind of x-rays, gamma rays or electrons to damage cancer cells so that they cannot multiply. Radiation dose to each site depends on a number of factors, including whether there are tissues and organs nearby that may be damaged by radiation. Thus, as with every form of treatment, radiation therapy is not without its side effects.The failure of these treatments to cure cancer completely triggers the need for the search of the alternate treatment methods.Alternate Treatment Methods: Alternate treatment methods are a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Many alternative medicine techniques are part of complete "systems" of healthcare that began many years before the development of conventional medicine. Often, these systems are the healthcare traditions practiced by a given culture. The popular alternate methods are Ayurveda, Homeopathy, Naturopathy, and Acupuncture etc.The conventional treatment methods concentrate on body, mind and soul to get the best results. Many complementary and alternative therapies are rooted in cultures whose healthcare practices are based on a holistic approach to wellness and healing.There is a great need of the search for improved quality of life and less toxic therapies, which cures cancer menace completely from the mankind.
About the Author
A Better Choice Foundation supports the search for a cure for cancer, emphasizing a non- traditional, holistic approach to a patient's Physical and emotional well-being. Rod Khleif is the founder of A Better Choice Foundation. Rod Khleif and A Better Choice Foundation focus on Research for holistic and non-traditional cures for cancer.

Cured From A SPLEEN CANCER and A 3B Stadium BREAST CANCER - PART 1

This article is made to announce publicly how my 74 years old aunt is cured from a SPLEEN CANCER and as well as a 3B Stage BREAST CANCER. This article is also to let those out there know there is HOPE and the fact that CANCER can be CURED!I know there are many women out there trying to struggle for their lifes out of Breast Cancer. Wjat I am going to tell here is a Story How My Aunt is Cured from Spleen Cancer and a 3B Stadium Breast Cancer after that. I really can't rewrite the story here again as I don't want to make an impression of double content.What I am going to do here is to give you the link to visit the page. I wrote it into several Parts so that I can still keep the story step-by-step on how it really happened, I am trying to tell precisely how it happened because Thank God, she is really fine now.Part 1 - The starting of Spleen CancerPart 2 - How she later got Breast CancerPart 3 - I started to get more information on what to do and what to consumePart 4 - How to consume the prescriptionandWhat She Consumed for 3B Stadium Breast Cancer Cured!Now I'm thinking, I really hope and wish I do a hard enough work to spread the news.The page is www.code4help.com ... have a visit, who know my words are someone else's hope.
About the Author
This article is made to announce publicly how my 74 years old aunt is cured from a SPLEEN CANCER and as well as a 3B Stage BREAST CANCER. This article is also to let those out there know there is HOPE and the fact that CANCER can be CURED! Visit www.code4help.com to read Part 1 - Part 2 and Part 3 of the Article

Cured from SPLEEN CANCER and from A 3B Stage BREAST CANCER - PART 2

This article is made to announce publicly how my 74 years old aunt is cured from a SPLEEN CANCER and as well as a 3B Stage BREAST CANCER. This article is also to let those out there know there is HOPE and the fact that CANCER can be CURED!I know there are many women out there trying to struggle for their lifes out of Breast Cancer. Wjat I am going to tell here is a Story How My Aunt is Cured from Spleen Cancer and a 3B Stadium Breast Cancer after that. I really can't rewrite the story here again as I don't want to make an impression of double content.What I am going to do here is to give you the link to visit the page. I wrote it into several Parts so that I can still keep the story step-by-step on how it really happened, I am trying to tell precisely how it happened because Thank God, she is really fine now.Part 1 - The starting of Spleen CancerPart 2 - How she later got Breast CancerPart 3 - I started to get more information on what to do and what to consumePart 4 - How to consume the prescriptionandWhat She Consumed for 3B Stadium Breast Cancer Cured!Now I'm thinking, I really hope and wish I do a hard enough work to spread the news.The page is www.code4help.com ... have a visit, who know my words are someone else's hope.
About the Author
This article is made to announce publicly how my 74 years old aunt is cured from a SPLEEN CANCER and as well as a 3B Stadium BREAST CANCER. This article is also to let those out there know there is HOPE and the fact that CANCER can be CURED! Read Part 1 - Part 2 and Part 3 of rhe Article on www.code4help

What Are The Treatment Options For Bone Cancer

Pain in the affected bone is the most common complaint of patients with bone cancer. At first, the pain is not constant and may be worse at night or when the bone is used (example is leg pain when walking). As the cancer grows, the pain will be there all the time. The pain increases with activity and may result in a limp if a leg is involved.Swelling in the area of the pain may not occur until weeks later. Depending on the location of the tumor, it may be possible to feel a lump or mass.Fractures: Although bone cancer may weaken the bone it develops in, the bones do not usually fracture. People with a fracture next to or through a bone cancer usually describe a limb that was sore for a few months and suddenly became severely painful.Generalized symptoms: If the cancer has spread, you may have generalized symptoms such as weight loss and fatigue.However, symptoms may vary depending on the location and size of the cancer. Tumors that occur in or near joints may cause swelling or tenderness in the affected area.The treatment options for bone cancerVarious forms of cancer treatments using surgery, radiation therapy, and chemotherapy for bone cancer are being tested in clinical trials.Clinical trials are a critical step in the development of new methods of treatment. Before any new treatment can be recommended for general use, doctors conduct clinical trials to find out whether the treatment is safe for patients and effective against the disease.Treatment options depend on the type, size, location, and stage of the cancer, as well as the person's age and general health.Although amputation of a limb is sometimes necessary, pre- or post-operative chemotherapy has made limb-sparing surgery possible in many cases.When appropriate, surgeons avoid amputation by removing only the cancerous section of the bone and replacing it with an artificial device called a prosthesis.However, a biopsy-the removal of a sample of tissue from the bone tumor-is needed to determine whether cancer is presentThe possible risk factors for bone cancerAlthough scientists are not certain what causes bone cancer, a number of factors may put a person at increased risk. These cancers occur more frequently in children and young adults, particularly those who have had radiation or chemotherapy treatments for other conditions.Adults with a noncancerous condition such as characterized by abnormal development of new bone cells, may be at increased risk for osteosarcoma.A small number of bone cancers are due to heredity. For example, children with hereditary retinoblastoma (an uncommon cancer of the eye) are at a higher risk of developing osteosarcoma.
About the Author
Copyright 2007 JackStowe. For more cancer related articles visit, http://ward911.blogspot.com Don't take your family's health for granted, know the facts of natural health. For more information and articles, visit http://natureheal.blogspot.com

Holistic and Non-Traditional Cures for Cancer

Holistic and non-traditional cancer treatments focus on the whole body, rather than just on the illness or part of the body. These treatments focus on the physical, mental, spiritual and emotional elements of the body, which are interconnected to maintain wellness. These therapies are used to prevent illness, reduce stress, prevent or reduce side effects and control or cure disease.Holistic and Non-Traditional approaches to Cure CancerHolistic and non-traditional treatment looks at disease as primarily resulting from internal imbalance. Non-traditional therapies are unconventional, unproven therapies that reject conventional treatments. While holistic therapies are used in combination with standard medical care and given by licensed or certified therapists.Non-Traditional Cancer TreatmentsNon-traditional therapies are used instead of conventional cancer treatments. Many of the most popular non-traditional therapies are including psychosocial such as relaxation practice, meditation and visual imagery are unlikely to pose threats to patients’ health. Besides these, there are certain important therapies such as,• Acupuncture: It is a technique of insertion of filiform needles into acupuncture points with an intension to restore the health and well-being.• Aromatherapy: It is the therapeutic use of aromatic essential oils to promote physical and psychological well-being.• Magnetotherapy: This therapy used by the application of magnets to the surface of the patient’s body. It is used to stimulate the recovery of the whole metabolism and reduce the deficiency of bone mineral substance. • Coffee enemas: These are the quick ways to remove toxins from the colon and body. A non-traditional doctor, or physician should only perform them under supervision.The other non-traditional therapies are, Cellular Therapy, Diet therapy, Herbal Therapy, Psychic Surgery, Shark cartilage therapy.Holistic Cancer Treatments An increasing number of health professionals are now exploring holistic cancer treatment options that encompass the whole individual, where the traditional treatment options form only art of the story. • Nutrition Therapy: Maintaining a healthy diet is the best way to provide the body with the nourishment it needs to fight cancer. • Naturopathy: It focuses only on using the healing powers of nature such as air, water and sunlight.• Pain Control: To certain extent medication can be used to manage pain. The pain could be brought on by the cancer itself or as its side effects. • Zeolite: It is a fast and powerful mineral substance with the ability to destroy cancer cells. They improve the alkalinity of the body and activate the P21 gene that can destroy the nucleus of cancerous cells.• Oxygen Therapy: It is a form of holistic treatment based upon the premise that all harmful bacteria, germs and viruses are anaerobic. They cannot resist in high oxygen environments. To maintain good health and vitality, the human body requires a rich supply of oxygen. Thus, holistic and non-traditional treatment approaches from several angles to cure cancer and suggests that a person should not only treat the illness but also have to reach a higher level of wellness.
About the Author
A Better Choice Foundation supports the search for a cure for cancer, emphasizing a non- traditional, holistic approach to a patient's Physical and emotional well-being. Rod Khleif is the founder of A Better Choice Foundation. Rod Khleif is a Florida’s real estate business man helping hundreds of people realizing their dream of owning a home.