[MOL] Herbs and suppliments!!!!! [00967] Medicine On Line


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[MOL] Herbs and suppliments!!!!!



>At a time when the possible health risks of dietary supplements have come under heightened scrutiny, the U.S. Food and Drug
>Administration has quietly stopped tracking cases in which herbal remedies have been linked to illness or death.
>
>The FDA, which is responsible for ensuring the safety of food and medical products, effectively shut its monitoring system 16 months
>ago after logging 2,621 "adverse reactions" -- including 184 deaths -- associated with herbal remedies.
>
>Top agency officials say they stopped tracking problems with dietary supplements because of budget constraints.
>
>"The system was never properly funded from its origin, and we've been paying for it ever since," said Joseph Levitt, director of the
>FDA's Center for Food Safety and Applied Nutrition.
>
>Critics charge that the agency's decision to suspend its monitoring program poses a significant public health risk, making it
>difficult for consumers and scientists to get early warnings about possible medical problems linked to
>herbal supplements.
>
>New reports of potential health risks associated with herbal remedies surfaced last week. The medical journal Lancet warned that St.
>John's wort, which some people take to treat depression or anxiety, may interfere with drugs prescribed for people with the AIDS
>virus and for organ transplant recipients.
>
>Although FDA officials insist the agency still monitors medical emergencies linked to dietary supplements, only three staff members
>are currently assigned to evaluate adverse reactions in the $12 billion dietary supplement industry, which includes more than 40
>public companies and hundreds of private firms.
>
>The agency cannot even say how many more adverse events have been reported since the monitoring system was last updated.
>
>"They (the FDA) simply do not now have an adequate system for capturing injuries that may be caused by dietary supplements," said
>Larry Sasich, an analyst with Public Citizen's Health Research Group, a Washington-based organization founded by consumer advocate
>Ralph Nader. "What we're especially worried about is that totally untested products are coming into the market."
>
>The FDA formed its Special Nutritionals Adverse Event Monitoring System in 1993 as a key element of the agency's MEDWatch program,
>which was designed to track problems with the range of drugs and medical products that the FDA is charged with regulating.
>
>The monitoring system was established to record adverse reactions including heart attacks, strokes, seizures, kidney damage,
>bleeding and deaths associated with more than 3,000 products ranging from herbal diet formulations to concoctions that promote
>natural highs.
>
>Those products are exempted from the rigorous testing and three-phase clinical trial programs that pharmaceutical drugs must
>undergo.
>
>The monitoring system has recorded more than 500 adverse reactions, including 38 deaths, linked to one product alone -- ephedra, or
>ma-huang, a powerful herbal stimulant used in weight-reduction and energy-boosting products.
>
>But the number of medical emergencies linked to dietary supplements has almost certainly been underreported. Unlike the monitoring
>system for regulated pharmaceuticals, which requires manufacturers to report side effects and illnesses, the dietary supplements
>system relies on voluntary reports of adverse reactions from the makers of herbal products.
>
>And some manufacturers have failed to reports thousands of medical problems linked to herbal products. For example, depositions in a
>current court case involving the death of a Sacramento woman show that E'ola, a Utah multilevel marketing firm, received 3,500
>customer complaints about its Amp II, an ephedra-based diet regimen.
>
>None of those cases was ever reported to the FDA, according to one top official with the company, in testimony taken by San
>Francisco attorney Christopher Grell.
>
>The FDA's lax efforts to ensure the safety of dietary supplements -- particularly the agency's decision to shut down its monitoring
>program -- have outraged some consumers.
>
>"How can they not monitor this stuff?" asked Martha, a 71-year-old Berkeley woman, who asked that her real name not be used. "The
>side effects can be horrendous."
>
>Martha began using senna, a laxative obtained from a subtropical shrub, several years ago because she suffered from constipation.
>
>"I was scared of those over-the- counter products," said Martha, who would put a capsule of senna in her herbal tea each night. "And
>the senna really worked."
>
>But last year she began suffering seizures and blackouts. She said she even became homeless for four days because she had locked
>herself out of the house and was so disoriented she could not ask for help.
>
>"Another time, a friend found me in the bathroom with a cut on my head and a broken collarbone," she said. "And I didn't know what
>happened."
>
>
>During a trip to the emergency room, doctors discovered that her sodium levels were dangerously low. They ordered her to stop taking
>the senna, which has been known to throw body electrolytes such as potassium and sodium out of balance.
>
>Martha's sodium levels are returning to normal since she stopped taking senna. She said she has had no more trouble with seizures,
>bloating or forgetfulness, common symptoms of sodium imbalance.
>
>"The government has got to step in and do some legitimate research on this stuff," said Martha.
>
>The FDA's dietary supplement monitoring system lists 29 adverse reactions to senna, which is also known as cassia angustifolia. Six
>deaths have been linked to senna on the agency's monitoring system.
>
>But dietary supplement advocates argue that the number of possible health risks associated with herbal remedies are minuscule when
>compared with the dangers associated with pharmaceutical drugs. They note that while the FDA's herbal monitoring system lists 184
>deaths associated with natural products, the FDA's prescription drug monitoring system records tens of thousands of deaths linked to
>pharmaceuticals.
>
>The FDA acknowledges in disclaimers that health problems linked to herbal supplements on the agency's adverse monitoring system may
>not be caused by that product. The monitoring system simply records cases where doctors or manufacturers noted that a connection
>between a health problem and an herbal product may exist.
>
>"That means anyone can report an adverse reaction," said Rob McCaleb, president of the Herb Research Foundation, one of the
>industry's most prominent nonprofit organizations. "There is no scientific follow-up by doctors or toxicologists to determine
>whether there was anything wrong with the supplement or if the supplement was even a causative factor."
>
>The agency and its herbal monitoring system have also been criticized by the federal General Accounting Office. Last July, the GAO
>charged that the FDA's adverse-reaction reports were incomplete, poorly documented and inadequate to use as a basis for rules that
>would set dosage amounts for herbal supplements.
>
>"The FDA needs to drop the adverse monitoring system or do it right, and I suggest they do it right," said Varro Tyler, dean of
>pharmacognosy at Purdue University and the eminence grise of herbals. "This argues for more investigation by the FDA into adverse
>reactions and into whether these products are harmful or being adulterated."
>
>But even while warning that the FDA's monitoring system was flawed, the GAO also called it "an invaluable tool for identifying
>potential serious public health issues."
>
>Sasich of Public Citizen said he is not arguing that herbals are more dangerous than prescription drugs. He says he is simply
>worried that little is being done to examine what harm might exist.
>
>"What we've allowed is a whole class of products to be introduced unscrutinized," he said, "and that is in conflict with our right
>to a marketplace free of untested products."
>
>The FDA requested an additional $2.5 million specifically to improve its dietary supplement monitoring system in its fiscal 2000
>budget. But it and several other FDA requests were cut in Congress as the Senate Subcommittee on Agriculture, Rural Development, FDA
>and Related Agencies tried to hold the line on spending.
>
>"That money is desperately needed for our system," said Levitt, who noted that the FDA had renewed its request as part of a 10-year
>plan to beef up the monitoring of dietary supplements.
Warmly, lillian
 
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