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Natural Solutions Radio #12<br>September 9, 2000

Beneficial Bacteria Helps Heal Intestines

High doses of probiotics, the beneficial bacteria that naturally lives in the intestinal tract, help control pouchitis, an inflammation of the small intestine common in patients with inflammatory bowel disease, a new study reports. To summarize:

As many as 50% of patients who undergo surgery for ulcerative colitis, develop pouchitis afterwards

Symptoms of pouchitis include:

Frequent and Urgent Bowel Movements
Abdominal Cramping
Bleeding
Fever

Most cases of pouchitis respond well temporarily to treatment with antibiotics, but the condition recurs 2 out of 3 times.

Pouchitis has been linked to reduced levels of some bacteria normally found in the intestinal tract.

In the study, 20 patients with chronic pouchitis received high-dose probiotics, while a 'control' group of another 20 patients received a placebo.
Throughout the 9 months of treatment, 85% of the probiotic group remained symptom-free, as determined with endoscopies and histological testing every 2 months.

All 20 people in the placebo group relapsed.

The probiotic preparation used contained 500 billion organisms per gram including 4 strains of lactobacilli, 3 strains of bifidobacteria, and 1 strain of Streptococcus salivarius subsp. thermophilus

Patients each received 6 grams daily of the probiotic.

Fecal concentration of lactobacilli, bifidobacteria, and S. thermophilus increased significantly in those taking the probiotics.

Benefits of the probiotics lasted only as long as patients continued taking them, with all patients relapsing within 4 months of discontinuation.

The researchers state that long-term use of the probiotics is safe. "Because it is a more natural therapy that enhances the body's normal protective factors, it has no side effects and can be administered for years."

SOURCE: Gastroenterology August 2000;119:305-309.



US Courts Forcing Parents to Medicate Kids for ADD/ADHD

Some public schools are accusing parents of child abuse when they balk at giving their kids drugs such as Ritalin, and as judges begin to agree, some parents are medicating their children for fear of having them hauled away by authorities.

There is a growing debate about diagnosing and medicating children with attention deficit disorder (ADD) and attention deficit and hyperactivity disorder (ADHD).

In Albany, NY, a couple put their 7 year old son back on Ritalin after a family court ruled that they must continue medicating him for ADD.

Child protective services visited a NY couple after anonymous allegations of "medical neglect" were reported after they took their son off of Ritalin and other drugs because of the side effects.

Maryland psychiatrist Peter Breggin says that often divorced parents disagree on medicating kids, and judges recently have ruled in favor of the parent who wants to medicate.

According to Peter Jensen, who is on the board of Children and Adults with Attention Deficit Disorder, the courts are going to rule in favor of medication more and more.

According to the American Academy of Pediatrics, 3.8 million school children are diagnosed with ADD/ADHD and at least 2 million take Ritalin, a stimulant, for symptoms such as inattentiveness, impulsivity and sometimes hyperactivity. Many others are treated with different drugs.

The long-term effects of children talking stimulants have not yet been studied.

William Frankenberger, who has studied ADD/ADHD at the University of Wisconsin-EAU Claire for more than 20 years, says it's "disturbing to take a decision like that out of parent's hands."

In an accompanying article, several parents described their personal stories. One couple had a police officer come to their door. Only the fact that they had gotten a second opinion IN WRITING that her son did not need to take any medication saved them from possibly having him taken into protective custody. They had decided to take him off of the medications that he was on - Ritalin, Dexadrine, and Paxil, because they caused serious side-effects such as withdrawl and hallucinations. Currently, their son is taking no medication and is on a special diet which helps with his condition.

SOURCE: USA Today August 8, 2000.



HEPATITIS C SCARE ORCHESTRATED BY DRUG COMPANY

Some of you may have noticed an upsurge of public awareness campaigns about hepatitis C, a supposedly slow progressing form of liver disease caused by a virus (that has never been truly isolated or shown to cause hepatitis in humans or animals). I was struck by front cover stories in some American AIDS magazines announcing a "twin epidemic" of HIV and HCV. Well, a reporter from the Washington Post did a little digging and discovered the source of all the hype: the drug company that manufactures Ribivarin, the main drug used for HCV infection. Under the guise of "protecting the public" the company in question has done a wonderful marketing campaign for a drug of questionable efficacy and safety.

SOURCE: The Washington Post, September 12, 2000, Tuesday, Pg.A01.



Herbal Supplements Are Regulated, Says Pharmaceutical Executive
Austin, TX. (September 20, 2000) - Despite erroneous media reports of an "unregulated industry," there are numerous federal laws and regulations that deal with the manufacture, labeling, and marketing of herbs and other dietary supplements, writes an executive with a pharmaceutical and dietary supplement trade association in the current issue of HerbalGram.

R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology of the Consumer Health Product Association, a major trade organization dealing with over-the-counter medications and dietary supplements, says that the idea that herbs are unregulated is a "myth."

Dr. Soller describes four federal laws under which herbs are regulated: Food, Drug, and Cosmetic Act (FD&C Act), the Nutrition Labeling and Education Act of 1990 (NLEA), the Dietary Supplement Health and Education Act of 1994 (DSHEA), and the Food and Drug Administration Modernization Act (FDAMA).

The HerbalGram article explains the "considerable enforcement authority" that both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have "to ensure safe, beneficial and quality dietary supplements for health promotion and maintenance and disease risk reduction, as intended by Congress in the passage of DSHEA. This article also demonstrates that in contrast to assertions to the contrary usually made by persons unfamiliar with regulatory issues, the herb and dietary supplement industries are substantially regulated, but these regulations are significantly different from those in the pharmaceutical industry."

In the area of regulations and their enforcement, from 1962 to 1999 FDA published 143 notices, actions, and proposed, interim and final rules in the Federal Register, the official publication of the U.S. government. Also, the FTC has initiated 70 cases against supplement manufacturers challenging or seeking documentation for claims made in product advertising.

The article also quotes FDA Commissioner Jane Henney, M.D., who told a House committee in 1999, "FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of the FD&C Act, as amended by DSHEA."

In general, the FDA has numerous powers:

* It can stop any company from selling a dietary supplement that is toxic or unsanitary;

* it can stop the sale of a dietary supplement that has false or unsubstantiated claims;

* it can take action against dietary supplements that pose "a significant unreasonable risk of illness or injury";

* it can stop any company making a claim that a product cures or treats a disease;

* it can stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance.

Further, FDA must require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices, GMPs), including potency, cleanliness and stability. Congress mandated FDA to develop new GMPs for dietary supplements in 1994, but FDA has not published final rules in this area.

In the area of the advertising and promotion of herbs and dietary supplements, the FTC has the power to:

* enforce laws outlawing "unfair or deceptive acts or practices" to ensure consumers get accurate information about dietary supplements, so they can make informed decisions about them;

* challenge and stop advertising that is not adequately substantiated;

* investigate complaints or questionable trade practices;

* negotiate a consent order or proceed through an FTC adjudication resulting in a cease and desist order, which can be broad in scope;

* seek injunctions to stop false advertisements or other violations of the FTC Act;

* seek civil penalties for violations of trade regulations or cease and desist orders.

The article appears in the most recent issue of HerbalGram (#49), a peer-reviewed journal on herbs and medicinal plant research published by the American Botanical Council (ABC).

ABC founder and executive director Mark Blumenthal said, "The article strongly suggests that current laws are adequate to deal with these products. The biggest problem is FDA's lack of enforcement of existing regulations and the its delay in publishing new GMPs for herbs."

Founded in 1988 in Austin, Texas, ABC is an independent non-profit research and education organization educating the public on the responsible use of medicinal plants. HerbalGram has been published since 1983 as a reliable and authoritative source of herb and medicinal plant research, regulatory and market issues, medicinal plant conservation and other general interest aspects of herb use. Information can be found on the organization's website:
www.herbalgram.org

SOURCE: R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology of the Consumer Health Product Association



FDA Drug Advisers Tied Directly To Pharmaceutical Industry
By Dennis Cauchon, USA TODAY

More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found.

These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed.

Number of drug experts available is limited

The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.

The conflicts typically include stock ownership, consulting fees or research grants.

Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998.

These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.

The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.

A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found:

At 92% of the meetings, at least one member had a financial conflict of interest.

At 55% of meetings, half or more of the FDA advisers had conflicts of interest.

Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.

At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

"The best experts for the FDA are often the best experts to consult with industry," says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions.

But Larry Sasich of Public Citizen , an advocacy group, says, "The industry has more influence on the process than people realize."



The Wishes of the Fetus:

On Sept. 6, the Ohio Supreme Court rejected a lawsuit by a 7-year-old girl with spina bifida, who had sued her parents' doctors because she wanted to have been aborted (since the doctors knew she would have birth defects). On the same day, in Attleboro, Mass., Judge Kenneth Nasif ordered a pregnant woman to be held in custody until she gives birth because he feared that she, because of her religion, might decline medical attention if she experienced complications; Nasif said he could "sense" the unborn child saying to him, "I want to live. I don't want to die like my brother (a previous victim of the woman's religion-based medical neglect) did."



Too Courteous

In August, Elsie Holdren, 68, a security officer working on contract at a courthouse in Viera, Fla., was transferred by her company to a courthouse in nearby Melbourne because her superiors thought she was too courteous. "Due to your caring and giving nature," wrote Holdren's supervisor (with Weiser Security Services in Orlando), "you are compromising your position as a security officer. (Being caring and giving) is not a job requirement, nor is it what you are paid to do."



Lone-Star Justice

The mentally retarded Felipe Rodriguez spent 13 months in jail in Swisher County, Texas (near Amarillo), after being accused of a minor theft, largely because his court-appointed defense attorney forgot about him until a Dallas Morning News reporter pestered her about the status of the case. (Rodriguez was released in August.) And a June New York Times report on veteran court-appointed defense lawyer Ronald G. Mock chronicled his career-long, mediocre representation of a series of now-executed men, including June executee Gary Graham, who was convicted based on one fleeting, nighttime eyewitness identification, which Mock neither challenged nor seriously investigated.



A WORD OF CAUTION

Any practices or advice given in this publication are not intended to replace the services of your physician, or to provide an alternative to professional medical treatment.

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