Dietary supplements' safety regulation: too much or not enough?

By Melissa Healy, Los Angeles Times/For the Booster Shots blog

January 26, 2012, 5:03 p.m.

A new proposal to toughen the Food and Drug Administration's power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts up in arms. But an editorial in the New England Journal of Medicine says the drug-safety agency's proposed new powers do not go nearly far enough.

To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use "novel" products -- minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in "mega-doses" much higher than have been customarily used in supplements. An industry that produced and marketed 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.

Since 1994, those selling "novel" products have been required to provide federal regulators with evidence supporting a product's "reasonable expectation of safety." In a New England Journal of Medicine "Perspective" article published this week, Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, suggests that even that vague standard has gone unenforced by the FDA and likely ignored by manufacturers eager to bring their supplements to market.

But in an effort to keep up, the FDA last July laid out a new raft of rules for those marketing "novel" dietary supplements in the United States. The new rules aim to spell out how a "reasonable expectation of safety" should be established. In some cases, the agency would accept documentation of a supplement's "historical use" outside the United States. For "mega-doses" that exceed commonly used levels of a given supplement, the agency wants to see evidence of safety from animal studies and from test-tube studies. (While trials using human subjects in testing a supplement's long-term use are allowed, they're not required).

These new requirements, writes Dr. Cohen, aren't enough. The "historical use" of a product where no one is looking for possible ill effects is a standard too low to assure safety, he writes. He adds that supplement manufacturers are under no obligation to share unfavorable safety data on a product with the FDA, so long as they offer studies that show the product is safe. And for products with no history of common use -- or marketed at super-high doses, "not even single-dose tolerability studies in humans would be required" by the new rules.

"If the FDA succumbs to industry pressure, the public health consequences will be significant," writes Cohen.

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Kaiser Permanente Unveils HIV Challenge to Help the U.S. Create Health Equity

PRESS RELEASE

Jan. 26, 2012, 8:00 a.m. EST

Best practices toolkit for health care organizations

WASHINGTON, Jan. 26, 2012 /PRNewswire via COMTEX/ -- Kaiser Permanente announced today the Kaiser Permanente HIV Challenge to help health care providers nationwide improve health equity for people living with HIV by increasing access to HIV care and improving health outcomes.

The HIV Challenge was announced at the Center for Medicare & Medicaid Innovation Care Innovations Summit in Washington, D.C. ( www.hcidc.org ).

Kaiser Permanente, the nation's largest nonprofit health care provider, has treated more than 60,000 people since the HIV epidemic emerged 30 years ago, and has reduced disparities among its current HIV population of more than 20,000 people by working to meet or exceed the objectives of the U.S. National HIV / AIDS Strategy.

The crux of the HIV Challenge (kp.org/hivchallenge) is to challenge other private health care providers and public and community health clinics to increase the number of HIV-positive people getting effective treatment by sharing Kaiser Permanente's toolkit of clinical best practices, provider and patient education materials, mentoring, training and health IT expertise.

http://www.youtube.com/playlist?list=PLFF12EC6E1E6A1EE7

HIV is still an epidemic in the United States, with 56,000 people becoming infected each year and more than 1.1 million Americans living with HIV, but one in five people with HIV don't know they are infected.

"The organizations presenting challenges here today are pushing the best minds in the country to create a better health care system. They represent exciting solutions to help address some of the nation's most urgent health needs," said CMS Acting Administrator Marilyn Tavenner.

Health care disparities are gaps in the quality of care associated with inequities encountered by racial, ethnic, poor and marginalized groups. The HIV Challenge is part of Kaiser Permanente's larger work to identify, measure, research and eliminate disparities in health and health care in the United States. To learn more go to kp.org/healthdisparities.

"Too many people are unaware they have HIV because access to effective prevention and care is insufficient," said Michael Horberg, MD, director of HIV/AIDS for Kaiser Permanente, executive director of research for Mid-Atlantic Permanente Medical Group, and a member of the Presidential Advisory Council on HIV/AIDS. "People with HIV need to get into treatment because quality HIV treatment prevents others from getting infected. Patients on effective therapy and better case management are living longer and more productive lives. However, quality HIV treatment requires effort."

Kaiser Permanente has demonstrated excellence in HIV clinical care outcomes with:

HIV mortality rates that are half the national average

94 percent median treatment adherence among patients regularly in care and on antiretroviral therapy

No disparities among its black and Latino HIV-positive patients for both mortality and medication rates, compared to a 15 percent higher rate in the United States for mortality and for medication

89 percent of its HIV-positive patients are in HIV-specific care within 90 days, compared to 50 percent in the U.S. within one year

69 percent of all its HIV-positive patients have maximal viral control compared to 19 percent to 35 percent nationally

As part of its HIV Challenge effort, Kaiser Permanente is sharing these best practices and tools for private health care providers and community health clinics to replicate: quality improvement programs that measure gaps in care; testing, prevention and treatment guidelines; how to set up multi-disciplinary care team models that emphasize the "medical home" so HIV specialists, care managers, clinical pharmacists and providers work together; and education for both the provider and patient.

For more details on the HIV Challenge, to download the best-practices toolkit and to watch videos of success stories in setting up HIV clinics and reducing disparities, go to: kp.org/hivchallenge

"Our success in the treatment of patients with HIV/AIDS results from the excellence of our clinicians, our advanced IT systems, our integrated delivery system and our effective coordination across specialties," said Robert Pearl, MD, chief executive officer and executive medical director of The Permanente Medical Group and Mid-Atlantic Permanente Medical Group. "In the same way that we have reduced the chances of our patients dying from cardiovascular disease and cancer significantly below the national averages, we have achieved outstanding clinical outcomes for our patients with HIV/AIDS."

The National HIV/AIDS Strategy ( http://www.aids.gov/federal-resources/policies/national-hiv-aids-strategy/ ) calls for increased testing so that all Americans can know their HIV status, increased access to culturally sensitive prevention messages, community-targeted prevention and condom and clean needle access. NHAS also calls for improving access to quality HIV care because HIV medications not only improve individuals' health and extend their life expectancy, they also reduce their risk of transmitting HIV to others. A recent scientific study found that effectively treating HIV patients with antiretroviral medications reduces HIV transmission by 96 percent. The study, known as HPTN 052, found that treating people with antiretroviral drugs before they are symptomatic can reduce the amount of virus in the blood sufficiently to reduce the risk of sexual transmission of HIV to an uninfected partner.

The Kaiser Permanente HIV Challenge is part of Kaiser Permanente's ongoing research of HIV and HIV treatment. Published Kaiser Permanente research studies include:

A study that found there are no disparities by race or ethnicity in risk of AIDS and death among HIV-infected patients in a setting of similar access to care, despite lower anti-retroviral therapy adherence among Latinos and blacks compared to whites.

A study that found HIV-infected patients are at increased risk for cancer as a result of both their impaired immune system and lifestyle factors, such as smoking.

A study that found 17 measures, such as screening and prevention for infections and monitoring of antiretroviral therapy, should be adopted uniformly to improve the quality of HIV care and treatment nationwide.

A study that found that cholesterol medications can work well among certain HIV patients who are at risk for cardiovascular disease.

About the Care Innovations Summit:

Sponsored jointly by the Department of Health and Human Services, the Centers for Medicare & Medicaid Services, Health Affairs, and the West Wireless Health Institute, the Care Innovations Summit brings together more than 1,000 health care leaders, entrepreneurs, innovators, government officials, and finance experts to stimulate investment in a high-quality, sustainable health care system. Made possible by the Affordable Care Act and the Obama Administration's commitment to open government, the Summit represents a new opportunity for industry and government to work together to help spur innovation in the public and private sectors to improve health care quality as never before and lower costs through improvement.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter .

For more information Danielle Cass, danielle.x.cass@kp.org, 510-267-5354 Farra Levin, farra.r.levin@kp.org , 510-267-7364

SOURCE Kaiser Permanente

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System to deliver organ transplant drug -- without harmful side effects

This is professor Ravi Kumar of the University of Strathclyde. Credit: University of Strathclyde

Public release date: 26-Jan-2012

Contact: Paul Gallagher
corporatecomms@strath.ac.uk
44-141-548-2370
University of Strathclyde

A new system for delivering a drug to organ transplant patients, which could avoid the risk of harmful side effects, is being developed by scientists at the University of Strathclyde in Glasgow.

The drug, cyclosporine (CsA), is widely used in transplant operations and helps prevent the patient's body rejecting the organ but it can cause adverse drug reactions, of which the most serious problems are kidney and liver damage, in the doses which are currently administered in the long term.

The gap between a safe, effective dose of the treatment and a toxic dose is extremely narrow but the Strathclyde scientists have found a way of capturing CsA in very small amounts. The new system, developed in laboratory tests, enables nanoparticles of the drug to be delivered orally so that the strength of the dose can be maintained, but at a level and in a form which spares kidneys from damage.

Professor Ravi Kumar, of the Strathclyde Institute of Pharmacy and Biomedical Sciences, led the research. He said: "CsA is very useful in transplants and treating conditions such as arthritis, lupus and some forms of diabetes, but we need to address the risks it can present to the kidney and liver, apart from various other toxicities such as convulsions and high blood pressure.

"The damage it can cause can be dealt with if it's caught at an early stage but can be irreversible if it continues unchecked. Furthermore, existing formulations of cyclosporine contain castor oil-based vehicle which is used owing to the drug's poor solubility in water but which can be toxic.

"By entrapping CsA in nanoparticles, we aimed to match the maximum concentration of the most potent formulation of the drug in market. In tests, we were able to strike a balance between strength, efficacy and safety and were able to make a marked increase in the drug's bioavailability- the level of the drug which becomes active in the system.

"We were also able to reduce the toxic effects on the kidneys by slow release of the nanoparticles, which brought the drug gradually to its maximum concentration.

"As well as its use in transplants, we hope to look into the effectiveness of this system with arthritis and address what is a hugely debilitating condition for many people."

The research paper has been published in the Journal of Biomedical Nanotechnology.

Further current research is aimed at proving the therapeutic efficacy and long-term safety of cyclosporine, with a special focus on the safety of carriers- polymers used in the formulation- to fulfil regulatory requirements. The safety studies element of the research has been funded by the Cunningham Trust Scotland and will conclude early in 2013.

The research forms part of Health Technologies at Strathclyde- one of the principal themes of the University's Technology and Innovation Centre (TIC), a world-leading research and technology centre transforming the way universities, business and industry collaborate.

Through Health Technologies at Strathclyde, academics work with industry and the health sector to find technologies for earlier, more accurate disease detection and better treatments, as well as life-long disease prevention.

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Live liver donation safer than previously thought

01/26/2012

Major surgery to donate a portion of liver does not interfere with long, healthy life

People who donate a portion of their livers for transplant to a relative or friend whose liver is failing can generally expect to live long, healthy lives and recover safely from the donation surgery, Johns Hopkins researchers have found.

“The donor process is safer than some have previously thought,” says transplant surgeon Dorry L. Segev, M.D., Ph.D., an associate professor of surgery and epidemiology at the Johns Hopkins University School of Medicine and leader of the study published in the February issue of the journal Gastroenterology. “Live liver donation is a serious operation with serious risks. However, in this largest study ever conducted in the United States, we have shown that it is safer than many previously believed, with a risk of death of 1.7 per thousand donors.”

The only treatment for end stage liver disease is transplant. Without a functioning liver, patients in liver failure die. Safe live liver donation is possible because the liver is an organ that regenerates itself relatively quickly, Segev notes, allowing the harvest of a small portion of the organ which, when transplanted, grows into a liver large enough to perform its crucial roles in blood detoxification, digestion and metabolism. The regenerative ability also means donors can survive well with a smaller segment of their own livers until they, too, regrow.

A decade ago, surgeons across the United States performed an estimated 500 live liver transplants a year. In 2002, however, there was a highly publicized death of a live liver donor. Since then, live liver donation may have been perceived as more dangerous than it actually is, Segev says, and now only 200 to 300 of these surgeries are performed annually, compared to 6,000 live kidney donations in the United States each year.

More than 16,000 people are currently on the waiting list for a liver transplant in the United States, while only around 6,000 livers are available from deceased donors. “For many, the risk of dying on the waiting list is higher than the chance of getting a deceased donor transplant," Segev says. "For the right patients, with the right needs and the right donors, live donor transplantation can be the best treatment option, and this study reassures us that the risk of a catastrophic complication remains low.”

To determine the safety of live liver donation, Segev and his colleagues combed data from all 4,111 donors in the United States between April, 1994, and March, 2011, and followed patients for an average of 7.6 years. There were seven donor deaths over the period in the 90 days following surgery, but the researchers say the long-term survival rate for donors was overall equal to the long-term survival of live kidney donors and a healthy control group culled from the National Health and Nutrition Survey.

Although the rate of live liver donor death was relatively low, Segev says it is still five times that of the risk of death for live kidney donors. A study by Segev published in the Journal of the American Medical Association in March, 2010, found that the rate of death in live kidney donation in the United States is 3.1 in 10,000. However, kidney donation is a simpler process, Segev notes. The operation itself is less complicated and kidney donors are left with one completely intact healthy kidney, which is typically able to compensate for the function of the one that is removed. By contrast, if a donor does not have enough healthy liver remaining after donation, he or she may not have enough liver function to get through the regeneration process, and might actually need a transplant to survive.

Segev says he was particularly interested in studying the outcomes for donors because most of those who offer to give up part of an organ come to the process very healthy. “The ideal risk of death from donating an organ is zero and we work as hard as we can to seek that ideal,” says Segev, director of clinical research in transplant surgery at Hopkins. “But in these serious, major operations, it is unlikely the risk will ever be zero.”
Other Hopkins researchers involved in the study include Abimereki D. Muzaale, M.D., M.P.H.; Nabil N. Dagher, M.D.; and Robert A. Montgomery, M.D., D.Phil.

For more information here.

http://www.hopkinsmedicine.org/transplant/

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“B A Hero” PSA Video Contest Announced by Hep B Free Philadelphia and Hepatitis B Foundation

Help Save Lives and Stop Hepatitis B Through a PSA Video Contest

Philadelphia, PA, January 26, 2012 --(PR.com)-- Hep B Free Philadelphia, a citywide and community-owned education campaign led by the Hepatitis B Foundation to save lives and stop hepatitis B, is calling on the Greater Philadelphia community to participate in its “B A Hero” Public Service Announcement (PSA) Video Contest 2012. Interested participants are asked to create 30-second PSAs to raise awareness about hepatitis B.

There are three opportunities to submit PSAs about the subject of hepatitis B awareness in relation to the “B A Hero” theme. Deadlines are Feb. 17, 2012; Mar. 16, 2012; and Apr. 13, 2012 – no later than 11:59 p.m. EST. There will be three separate judging periods in which video submissions will be added to the Hep B Free Philadelphia Facebook page and Facebook users will have the opportunity vote on their favorite video. Three finalists will be identified and each will receive a prize of $100. The grand prize winner, selected by Hep B Free Philadelphia and Hepatitis B Foundation representatives, will receive an additional $150 and their PSA will be shown at the 2012 Philadelphia Asian American Film Festival and Hep B Free Philadelphia’s annual media event.

“Hepatitis B is a serious infection that affects at least 2 million people in the U.S. It is often known as a silent killer because its symptoms tend to be hidden until it’s simply too late,” said Chari Cohen, Hepatitis B Foundation Associate Director of Public Health. “By offering this PSA video contest, we are hoping to engage people in the Philadelphia region, create awareness about hepatitis B and help saves lives by having people get tested for this preventable and treatable disease.”

To be eligible to participate in the contest, individuals must be 18 years of age or have consent of legal guardianship and must physically live in the Greater Philadelphia region. Companies that are incorporated in the Greater Philadelphia region are also eligible. Within this contest, the Greater Philadelphia region is defined as the Pennsylvania counties of Berks, Bucks, Chester, Delaware, Lancaster, Lehigh, Montgomery and Philadelphia.

Video submissions can be in any style or genre of film or video including, but not limited to, animation, drama, still art, imagery, comedy or documentary. Videos should be formatted as MPEG-4, 320x240 files. When submitting via traditional mail or hand-delivery, the files must be saved on DVD-R discs and delivered to the Hepatitis B Foundation at 3805 Old Easton Road, Doylestown, Pa. 18902. Videos can also be submitted through the Hep B Free Philadelphia Facebook page or via large file transfer Web services to PSAContest@hepb.org. All entries must be received on or before the deadlines for contest eligibility. To learn more, go to www.hepbfreephiladelphia.org/2012/hepbpsacontest or contact Hep B Free Philadelphia Program Manager Daniel Chen at Daniel.chen@hepb.org.

About Hep B Free Philadelphia: Hep B Free Philadelphia is a public awareness and education campaign that has been launched to address the growing severity of hepatitis B and liver cancer in the U.S. The primary goals of the Philadelphia campaign include raising the public profile of hepatitis B and liver cancer as an urgent health priority; increasing hepatitis B testing and vaccination rates, particularly among at-risk populations; and involving and mobilizing stakeholders and policy decision-makers to improve access to care for both the prevention and treatment of hepatitis B and liver cancer. To learn more, go to www.hepbfreephiladelphia.org.

About the Hepatitis B Foundation: The Hepatitis B Foundation is the only national nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org or call (215) 489-4900.
###

Contact Information

Hepatits B Foundation
Leah Ludwig
215-340-0480
Contact

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The answers are in your blood

Yes, you need to face the needle: Regular tests are best

By Amy Leap Pocono Record Writer

January 26, 2012

The body is an intricate machine, and normally all the organs and functions work together to keep you healthy. But doctors need to check now and then to ensure everything is working as it should — and an external exam won't suffice.

"Blood tests are one of the best ways for a physician to gain information about your health," said Anna Friemann of Hamilton Township. She is a nurse in the Level II Neuro Trauma Center at Community Medical Center, Scranton.

The Centers for Disease Control and Prevention advises having routine blood tests done somewhere around 35 and 40 years old. This gives the doctor a starting point to monitor any changes as you get older.

"At around the age of 50, there are specific blood tests the doctor should order on a yearly basis, and if you haven't had the tests, you should ask the physician about having them," she said.

When the doctor orders the lab to run a complete series of tests, you can find out about the status of the liver, the thyroid, the blood cholesterol as well as the blood sugar, Friemann said.

Women and men 50 and older

The following blood chemistry tests require a single sample of blood serum, which may require several vials of blood that can be used to run a series of tests quickly and inexpensively.

The following are the most commonly requested tests:

r Complete Blood Count is the most common test and is usually ordered as part of a complete physical examination. CBC measures the number, size and shape of the types of cells in the blood.

r Glucose test can indicate diabetes if the level is high, or hypoglycemia if it is low. A fasting glucose of less than 100 is normal, a level of 100 to 125 is abnormal and called "impaired glucose tolerance" and a level of 126 or greater means diabetes.

r Blood Urea Nitrogen and creatinine tests see if the kidneys are working normally and measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. If the kidneys are not able to remove urea from the blood normally, the BUN level rises.

The level of creatinine in the blood also tells how well the kidneys are working. A high creatinine level may mean the kidneys are not working properly. BUN and creatinine tests can be used together to find the BUN-to-creatinine ratio that tells if the kidneys are working properly.

r Sodium, potassium and chloride tests are especially important when taking diuretics, known as water pills. The tests measure the blood salts or electrolytes.

r Uric Acid test measures the level of acid, a waste product of all cells. An elevated level could mean kidney disease or gout.

r Albumin test measures the blood protein the liver produces. A low albumin count can be a sign of liver or kidney disease.

r Globulin test measures the level of blood protein produced by the immune system. A high level can point to chronic inflammation, infection or blood disorders, such as multiple myeloma.

r Calcium test has nothing to do with how much calcium is in the bones. It is a component of the blood that helps all the cells in the body function normally. A high count can point to a disorder called hyperparathyroidism, which predisposes people to kidney stones and low bone density.

r Serum Glutamine Pyruvic Transaminase test measures an enzyme normally present in liver and heart cells. SGPT is released into the blood when the liver or heart is damaged. Elevated levels of SGPT can happen as a result of a heart attack or from viral hepatitis.

r Lactate Dehydrogenase test measures an enzyme produced by many cells of the body. If LDH is extremely high, it can indicate a malignancy, and the doctor will do additional tests to rule this out.

r Bilirubin test measures a chemical in bile that gives it the yellow color. If the bile passages from the liver to the intestine are blocked, the bilirubin level will be high. Possible causes include gallstones and liver disease.

r Gamma Glutamyl Transpeptidase test measures the amount of enzyme produced by the liver. Obesity and excessive alcohol use are the most common reasons it can be mildly increased. It will also be elevated when there is blockage of bile and with liver disease.

r Blood fats or blood lipids test identifies lipids, often listed together in a separate "panel" on the blood chemistry report as Low Density Lipoprotein and High Density Lipoprotein. The total cholesterol is the sum of the LDL and HDL. High total cholesterol levels are linked to heart disease. The lower the total cholesterol the better. A total below 200 is desirable.

HDL is the good cholesterol. The more of it, the better. Ideally, the HDL cholesterol should be at least 30 percent of the total amount. In men, an HDL greater than 40 is normal; in women, an HDL greater than 50 is normal.

LDL is the bad cholesterol. A high LDL puts the patient at risk for heart disease, and the doctor will suggest diet and often medication to get the LDL cholesterol below 130. If diabetes or heart disease is present, the treatment goal for LDL cholesterol should be below 100.

Triglycerides are the other form of fat in the blood. The level will be much higher after a meal. If the level is out of range, it should be repeated after an overnight fast. Elevated levels increase the risk of heart disease and could be a sign of early diabetes. Ideally, they should be under 150.

r Thyroid function test can diagnose an underactive thyroid, a common condition in women over age 50. It also measures the level of two hormones produced by the thyroid glands: thyroxine 3 (T3) and thyroxine 4 (T4). Both regulate the metabolism.

The brain keeps levels normal by sending thyroid stimulating hormone (TSH) to the thyroid gland if the T3 and T4 are low. The TSH level is the best indicator of the condition of the thyroid and the effects of thyroid medication.

For example, if the thyroid hormone levels (T3 and T4) are low, the TSH level will be high. If the thyroid hormone levels are too high, then the TSH level will be low or immeasurable.

Just for women

r C-reactive protein test measures blood inflammation and marker of future heart disease risk. The test is recommended for women with a waist circumference over 35 inches because of increased risk for metabolic syndrome and heart disease.

Just for men

r Prostate-Specific Antigen test measures the prostate-specific protein produced by cells of the prostate gland. A high PSA can mean prostate cancer or prostate inflammation.

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