FDA Completes Final Analysis of “Total Body Formula” and “Total Body Mega Formula” Products
Testing reveals high chromium levels in addition to selenium

Source: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01831.html

The U.S. Food and Drug Administration’s final analysis of certain flavors of “Total Body Formula” and “Total Body Mega Formula” has detected hazardous amounts of chromium.

On April 9, 2008, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html) Further FDA analysis of the products found high levels of chromium as well. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

The new FDA finding comes as the U.S. Centers for Disease Control and Prevention (CDC) reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor after receiving reports of adverse reactions. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html).

The FDA continues to investigate how excessive amounts of selenium and chromium got into the products.

The sole distributor of the “Total Body Formula” and “Total Body Mega Formula” products has voluntarily recalled the affected products.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

More information about selenium and chromium and toxic effects of excessive intake is available from the CDC and the Agency for Toxic Substances and Disease Registry at: http://www.atsdr.cdc.gov/.

 

 

By KEVIN SACK
Published: February 18, 2008
Source: http://www.nytimes.com/2008/02/18/health/18cancer.html

ATLANTA — A nationwide study has found that the uninsured and those covered by Medicaid are more likely than those with private insurance to receive a diagnosis of cancer in late stages, often diminishing their chances of survival.

The study by researchers with the American Cancer Society also found that blacks had a higher risk of late diagnosis, even after accounting for their disproportionately high rates of being uninsured and underinsured. The study’s authors speculated that the disparity might be caused by a lack of health literacy and an inadequate supply of providers in minority communities. The study is to be published online Monday in The Lancet Oncology.

Previous studies have shown a correlation between insurance status and the stage of diagnosis for particular cancers. The new research is the first to examine a dozen major cancer types and to do so nationally with the most current data. It mined the National Cancer Data Base, which began collecting information about insurance in the late 1990s, to analyze 3.7 million patients who received diagnoses from 1998 to 2004.

The widest disparities were noted in cancers that could be detected early through standard screening or assessment of symptoms, like breast cancer, lung cancer, colon cancer and melanoma. For each, uninsured patients were two to three times more likely to be diagnosed in Stage III or Stage IV rather than Stage I. Smaller disparities were found for non-Hodgkins lymphoma and cancers of the bladder, kidney, prostate, thyroid, uterus, ovary and pancreas.

When comparing blacks to whites, the disparities in late-stage diagnosis were statistically significant for 10 of the 12 cancers. Hispanics also had a higher risk but less so than blacks.

The study’s authors concluded that “individuals without private insurance are not receiving optimum care in terms of cancer screening or timely diagnosis and follow-up with health care providers.” Advanced-stage diagnosis, they wrote, “leads to increased morbidity, decreased quality of life and survival and, often, increased costs.”

The study cites previous research that shows patients receiving a diagnosis of colon cancer in Stage I have a five-year survival rate of 93 percent, compared with 44 percent at Stage III and 8 percent at Stage IV.

“There’s evidence that not having insurance increases suffering,” said Dr. Otis W. Brawley, the American Cancer Society’s chief medical officer.

Not all cancer researchers believe that comprehensive screening and early detection is universally constructive. They argue that with certain cancers, like melanoma and prostate cancer, it can lead to misdiagnosis and overdiagnosis, with doctors identifying and treating tumors that may never cause serious problems. In some of those cases, surgery and drug therapies may actually shorten lives.

“Do these findings mean that patients without insurance are being diagnosed too late, or that insured patients are being excessively diagnosed?” said Dr. H. Gilbert Welch, a professor at Dartmouth who studies the usefulness of medical procedures. “And if it does mean that too many are being diagnosed late, we don’t know if it’s the problem of not being insured or a problem of cultural norms and patient education.”

Dr. Brawley said that the cancer society, the largest and wealthiest of the disease-centered philanthropies, received no more than 5 percent of its $1 billion in revenues from corporate donations, including some from medical suppliers and drug-makers that stood to profit from expanded screening. He said the group had rejected contributions from companies it considered directly connected to its research, and that he saw no conflict in the study on cancer and insurance.

The cancer society, Dr. Brawley said, has been conservative in its screening recommendations, which vary by cancer type and age. The study’s results, he said, would encourage broader screening for breast, colon and cervical cancers, where early detection has reduced death rates, but not necessarily for other cancers.

Source: http://www.cbsnews.com/stories/2001/07/30/national/main304038.shtml

(CBS) Families turn to nursing homes to give the elderly the care and attention they need, but a congressional report out Monday says 1,600 U.S. nursing homes — nearly one-third — have been cited for abuse, reports CBS News Correspondent Bill Whitaker.

Some 5,283 nursing homes were cited for abuse violations, according to a review of state inspection records requested by Rep. Henry Waxman, D-Calif. These homes were cited for nearly 9,000 abuse violations from January 1999 to January 2001.

“We found examples of residents being punched, choked or kicked by staff members or other residents,” Waxman said.

It’s a shocking reality for thousands of older Americans, a trend CBS News first reported last year with the story of Helen Love. She was attacked by a certified nurse’s assistant at a Sacramento facility, who was angered she’d soiled herself.

“He choked me and went and broke my neck and broke my wrist,” said Love.

Helen Love died two days after her interview. Her assailant got a year in county jail and a CBS News investigation found that three other employees at the same Sacramento facility had been convicted for abuse, which should have barred them from nursing home work.

The nursing home industry agrees on the need for stiffer background checks, but disagrees abuse is widespread.

“The congressman himself said the great majority of long-term care in our nation is excellent. There are people every day that are working very hard to provide that care,” said Charles H. Roadman II, president of the American Health Care Association (AHCA), a nursing home trade group that represents 12,000 nonprofit and for-profit centers and homes for the elderly and disabled.

Waxman, the top Democrat on the House Government Reform Committee, which oversees spending and other operations, said Congress should re-estalish an abolished federal law that boosts nursing home spending. The Boren amendment would guarantee that the nation’s nearly 17,000 homes do a better job of screening, training and counseling their staff. Roughly 1.5 million seniors live in nursing homes.

Waxman is also introducing a plan that would require criminal background checks on nursing home staff and impose tougher standards on homes with violations.

The AHCA supports a federal criminal background check system for potential employees.

“Recruiting, training and keeping frontline nursing staff are among the most important things we can do to ensure our patients continue to receive quality skilled nursing care,” said Roadman.

But center operators said abuse is not the norm in nursing homes and many staff members deserve praise.

“Our patients are like family, and incidents like those described here today are extremely rare,” said Sharon Sellers, vice president of operations at Washington Home, a nearly 200-bed center in the District of Columbia.

Bruce Rosenthal, spokesman for the American Association of Homes and Services for the Aging, said Congress should focus on the troubled centers, rather than create cumbersome standards for all.

“We strongly believe nursing homes that exhibit consistently poor performance should either clean up their act or be put out of business,” said Rosenthal, whose group represents 5,600 not-for-profit homes and centers.

A congressional report has found that 5,283 — over 30 percent — of the nursing homes in the U.S. were cited for an abuse violation that had to cause harm between January 1999 and January 2001. Over 2,500 of the violations were serious enough to cause actual harm or to place residents in immediate jeopardy of death or serious injury. Click here to read the entire report.

The reported abuses were physical, sexual and verbal. All abuse is on the rise, the report said. More than twice as many nursing homes were cited for abuse in 2000 than in 1996. In 1996, 5.9 percent of all nursing homes were cited for an abuse violation during their annual inspections; in 2000, 16 percent of nursing homes were cited.

“It would have been intolerable if we had found a hundred cases of abuse; it is unconscionable that we have foud thousands upon thousands,” Waxman said.

The report found that in 1,601 nursing homes - about 1 in 10 - abuse citations were made in serious incidents that either put residents at great risk of harm, injured them or killed them.

For instance, a resident was killed when another resident with a history of abusive behavior picked her up and slammed her into a wall. In another case, a resident’s nose was broken by an attendant who hit her. An attendant raped another resident in her room.

It was not clear how many people were abused. In some cases, the report said, an abuse citation referred to a single victim; in others a single case affected several residents.

Investigators said many violations are neither detected nor reported, leading officials to believe the problem is underestimated.

The report also found:

more than 40 percent, or 3,800 abuse violations, were only reported after formal complaints from residents, their families or community advocates.

1,327 homes were cited for more than one abuse violation in the two-year period; 305 homes were cited for three or more abuse violations, and 192 nursing homes were cited for five or more abuse violations.

Helpful information on Medication Errors.

Source: http://www.fda.gov/consumer/updates/medtips062107.html

1. Find out the name of your medication. Rather than simply letting your doctor write a prescription and send you on your way, be sure to ask the name of the medication. “This way you’ll notice if the pharmacy gives you something different,” says Cynthia Fitzpatrick, BSN, a registered nurse and a consumer safety officer in FDA’s Center for Drug Evaluation and Research. “Also, every time you receive a refill, look at the medication before you leave the pharmacy to make sure it looks the same as what you had before. Is it the same color, size, shape, and texture? Is the packaging the same? If anything about the medication seems different, ask the pharmacist about it.”

2. Ask questions about how to use the medication. “It’s important to choose a doctor and pharmacist that you feel comfortable with so that you can freely ask questions,” Fitzpatrick says. Some good questions to ask: What should I do if I forget a dose? Should I take this medication before, during, or after meals? What should the timing be between each dose? What side effects might I have? When should I contact my doctor or pharmacist if I experience certain side effects? Are there any other medications, food, or activities that I should avoid while using this medication? Should the medication be stored in the refrigerator or at room temperature? Take notes or ask your doctor to write down instructions or other information that is important to know about your medication or condition to help you remember.

3. Know what your medication is for. Stephen Setter, Pharm.D., associate professor of pharmacotherapy at Washington State University in Spokane, says one of his patients mistakenly thought her glaucoma medication was for treating headaches. “So she was taking her eye medication only when she had a headache, but she should have been taking it every day to treat her eye disease,” Setter says. It’s important to understand your medication because you are more likely to use it correctly, more likely to know what to expect from the medication, and better able to report what you are using and problems to your doctors and pharmacist.

4. Read medicine labels and follow directions. Before you use any medication, you should know when to use it, how much to use, and how long to use it. Be sure to read the medication label every time. In the middle of the night, you could accidentally put drops for your ears into your eyes or give your older child’s medicine to the baby if you’re not careful about checking the label. “Use the measuring device that comes with the medicine,” suggests Fitzpatrick. “If you don’t have a medicine device for measuring your liquid medicine, ask for one at the pharmacy.” Also, read the patient medication information that comes with your prescription thoroughly before using your medication.

5. Keep all of your health care providers informed about your medications and dietary supplements (including vitamins and herbals). Make it a habit of showing your list of medications to all your health care professionals at every visit to the doctor, the pharmacy, and the hospital. Include on the list all your prescription and over-the-counter medications, and dietary supplements, including vitamins and herbals. Keeping all of your health care professionals informed about everything that you use will help ensure that you do not use two medicines with the same active ingredient or use anything that will interact with something else you are using. You can keep your health care professionals informed about your medications and dietary supplements with “My Medicine Record,” a list in chart form developed by FDA. “My Medicine Record” can be found at: www.fda.gov/cder/consumerinfo/my_medicine_record.htm

Some doctors work with their patients to do a “brown bag checkup.” This involves putting all of your prescription and over-the-counter medications into a paper bag and bringing them into your doctor’s office to be checked by your doctor. Include your dietary supplements and herbals too. “This should be done every year and preferably more often,” says Douglas Paauw, M.D., professor of medicine at the University of Washington in Seattle. “Some of my patients do it at every visit.”

6. Keep the list of your medications with you at all times and let a loved one know. Keep a list of your medications and dietary supplements with you at all times, such as in your wallet or purse, and keep a copy in your home. Share a copy of the medication list with a family member or friend, or let them know where you keep the list. In an emergency, that person will be able to inform your doctors of the medications and dietary supplements you use.

If you think your full coverage auto insurance policy will protect you, think again. After tragic accidents, families across Ohio are finding a gap in their coverage.
Peter Traska, an attorney with Elk & Elk who specializes in appealing these types of cases said “very often, it’s a family dealing with a catastrophic loss. And when they have an accident, it’s too late.”
Source: http://www.newsnet5.com/

Cleveland, OH - One day, a normal little boy is at play in his yard.
The next, his family is devastated by his sudden and mysterious death. They claim that a suburban hospital is to blame.
19 Action News Investigator Carl Monday searches for the answers in an emotional story that will frighten any parent. http://www.woio.com/