November 9, 2007

Natural Products Association Responds to Misinformed and Misleading Articles in New York Times, Reader’s Digest
Association Counters Negative Conclusions and Substantiates Safe and Effective Use of Supplements

Recent articles in both the Reader’s Digest and New York Times unfairly and inaccurately depicted dietary supplements as either unregulated or unsafe. The Natural Products Association contacted both publications to set the record straight.

In an article titled “the Vitamin Hoax — 10 Not to Take,” the November issue of Reader’s Digest took aim at the use of supplements as part of living a healthy lifestyle. The Natural Products Association’s executive director and CEO, David Seckman, in a letter to Reader’s Digest corrected many of the errors and underlying assumptions in the article.

“While the story was full of inaccuracies, the cover was especially troubling because it may lead people who are safely and beneficially taking vitamins to stop, actually putting their health at greater risk,” Seckman said. “Proper nutrition continues to be a huge health challenge for America, with one of every four Americans (over 75 million, including children), not getting the recommended daily allowance of nutrition in their daily diets. Likewise, only 23 percent of Americans get the recommended five servings of fruits and vegetables per day that they need. Sure, we all wish we could eat pyramid-perfect diets, but the reality is far different, and that’s where nutritional supplements play a very important role.”

In challenging recent claims that antioxidant vitamins increase mortality, Seckman cited the fact that more than 160 million people in North America and Europe take antioxidants. “If a true mortality risk had become apparent in any of these clinical studies, those studies would have been halted,” Seckman said. “They were not. On the contrary, surveys show repeatedly that in general, people who use dietary supplements are healthier than those who don’t.”

Additionally, Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association, responded to a piece in the New York Times about the suspension of professional baseball player Mike Cameron that contained numerous inaccuracies about oversight and regulation in the natural products industry and fed into the misconception, fueled by athletes caught breaking the rules, that supplements are unregulated and contain banned substances.

“For too long now, the dietary supplement industry has been the convenient scapegoat, No. 1 on the excuse list of a number of professional athletes who get caught taking banned substances, to the extent it is blatant,” said Fabricant. “Mr. Cameron’s confession is the latest, but follows a similar refrain: blame ‘tainted supplements’ in the abstract, but withhold the specific name of the product, manufacturer, label, or where the supplement was purchased. The bottom line here is that dietary supplements are regulated by the federal government and they are not permitted to contain banned substances, period.”

Fabricant also had strong words regarding a Cornell University nutrition professor quoted in the article who claimed supplements were “unregulated” and contamination was common.

“That is not only absurd, it is especially astonishing coming from an academic who should know better,” said Fabricant, and went on to cite specific examples.

Editor’s Note: Since both letters are submitted to be published, the Natural Products Association cannot print them in their entirety pending notification by the publications. Updates will be posted on the NPA website when they are available to view and members will be notified. In the meantime, to get the facts about dietary supplements, including scientific citations and regulatory authority, go to www.NaturalProductsAssoc.org/supplementfacts.

A federal jury acquitted a prominent Reno doctor on Thursday of charges he trafficked in a human growth hormone.

Dr. James Forsythe, 69, said the charges had robbed him of his practice and he was eager to return to his work.

His attorneys said that while he was the target of an undercover sting operation in 2004 he twice prescribed the drug to a Food and Drug Administration agent to treat a legitimate health condition.

“I’m ecstatic,” attorney Kevin Mirch said. “I’m glad we persuaded the jury that the doctor is innocent.”

Federal prosecutors argued that Forsythe - with a patient list that includes top casino executives and Nevada first lady Dawn Gibbons - sold the drugs illegally for anti-aging purposes, falsifying the diagnosis of a growth hormone deficiency to cover his tracks.

The 12-member jury deliberated for about two hours in U.S. District Court in Reno Wednesday afternoon and returned its verdict at midmorning on Thursday after hearing closing arguments and listening again to secret tape recordings the undercover agent made of Forsythe, who is married to former Nevada Republican Party Chairwoman Earlene Forsythe.

Senior Judge Howard McKibben on Tuesday dismissed one of two counts the Justice Department brought against Forsythe, saying there was no evidence he introduced the drugs into interstate commerce from Israel without required approval.

The remaining charge accused him of distributing Bio-Tropin as an unapproved anti-aging treatment. If convicted, he would had faced up to five years in prison and a $250,000 fine.

Mirch said FDA agents launched the investigation based on the mistaken understanding the drug had not been approved by the federal agency.

Mirch said when they learned it was simply a new name for a previously approved growth hormone, prosecutors changed their strategy to argue that the drug could be prescribed for adults only in special circumstances, including treatment of hormone deficiency and AIDs wasting.

Mirch said the agency exerted “too much power” in a rush to indict Forsythe in 2005.

“He is a good man,” Mirch said. “He has lived since 2004 with absolutely the most horrible cloud over his head, his family’s head and his colleagues’ heads.

“They wanted to get him. They wanted to embarrass the people on this (patient) list and they did. They should have apologized and let this man who is 69 years old attend to his patients like he has for 40 years.”

Assistant U.S. Attorney James Keller said Forsythe didn’t do many of the tests experts said are necessary to determine whether someone suffers from a hormone deficiency.

“This case is not about whether the defendant is a good doctor or whether he practices good medicine,” Keller said.

“You are simply here to determine whether he followed the law and whether he distributed the drug for unauthorized purposes,” he said.

Keller brushed out of the courtroom on Thursday, ignoring a reporter’s request for comment.

On the tape recording, the undercover agent tells Forsythe a man he knows from the gym referred him to Forsythe. He said he had searched on the Internet and been reading about human growth hormones.

Forsythe responded, “So you’re mainly interested in HGH for energy purposes, getting back into shape?” He then told the agent they provide such treatment at his clinic.

Keller said the doctor made a reference to a book entitled “Feel Good with HGH” and handed out a pamphlet “Healthy Aging, Passport to a Better Life.”

“Doesn’t it show he’s doing it for anti-aging purposes?” Keller asked the jury. “He prescribed it for anti-aging, lack of energy - those things for which we want to make us feel younger.”

“There were no questions about the pituitary gland or trauma to the head,” Keller said, which experts testified can cause such a condition.

“Doesn’t that seem like a cover?” Keller asked. He also questioned why Forsythe didn’t write the agent a prescription to take to a pharmacy.

“Why distribute it out of his office? What’s being hidden here?” he said.

Mirch said the government used snippets of the tape out of context “to somehow state that Dr. Forsythe does not have the capacity to tell if someone has a growth hormone deficiency.”

“The government tried to tell you if Dr. Forsythe didn’t do what they consider proper tests, that is a crime. It is not,” he said. “He can prescribe it and give it to that patient if he believes that (diagnosis). It is an allowed use.”

Mirch said the defense team was able to determine that the agent once suffered a stroke, which he compared to head trauma, something the agent had kept from the FDA and Justice Department prosecutors.

“You don’t let an unqualified sick person make the decision to indict a doctor who has a sterling reputation for years and years and years,” he said.

Editor’s Note:

As many of you may already know, cellular energy is synonymous with metabolic power.  As we age, there is a decrease in metabolism; furthermore, numerous disease states and their treatments involve metabolic dysfunction (i.e. degenerative conditions, ischemia/stroke, and cancer). 

The power plant of the cell is the mitochondria.  It generates the energy through production of ATP, our energy source. If this can be supported, protected and enhanced then the typical issues related to fatigue and cellular breakdown can be averted.

Palladium Lipoic Complex (available in dietary supplement form as Poly-MVA) is a compound composed of the mineral palladium bound to the antioxidant lipoic acid in a trimer around thiamine (B1). Poly-MVA is a patented, proprietary supplement that contains LAPd complex, riboflavin, cyanocobalamin, formyl-methionine and acetyl-cysteine. This supplement targets not only protection for the cell but it also enhances and generates support for the mitochondria to help our cells create energy that directly supports our energy levels.

“Coping With Fatigue”

Fatigue is often confused with tiredness. Tiredness happens to everyone — it’s a feeling you expect after certain activities or at the end of the day. Usually, you know why you are tired and a good night’s sleep solves the problem.

Fatigue is a daily lack of energy; it is excessive whole-body tiredness not relieved by sleep. It can last for a short time (a month or less) or stay around for longer (1-6 months or longer). Fatigue can prevent you from functioning normally and gets in the way of things you enjoy or need to do.

Cancer-related fatigue is one of the most common side effects of cancer and its treatment. It is not predictable by tumor type, treatment, or stage of illness. Usually, it comes on suddenly, does not result from activity or exertion, and is not relieved by rest or sleep. It is often described as “paralyzing” and may continue even after treatment is complete.

What Causes Cancer-Related Fatigue?

The exact reason for cancer-related fatigue is unknown. It may be related to the disease itself or its treatments.

The following cancer treatments are commonly associated with fatigue:

• Chemotherapy. Any chemotherapy drug may cause fatigue, but it may be a more common side effect of drugs such as vincristine, vinblastine, and cisplatin. Fatigue usually develops after several weeks of chemotherapy. In some, fatigue lasts a few days, while others say the problem persists throughout the course of treatment and even after the treatment is complete.

• Radiation therapy. Radiation can cause fatigue that increases over time. This can occur regardless of the treatment site. Fatigue usually lasts from 3 to 4 weeks after treatment stops, but can continue for up to 2 to 3 months.

• Combination therapy. More than one cancer treatment at the same time or one after the other increases the chances of developing fatigue.

• Bone marrow transplant. This aggressive form of treatment can cause fatigue that lasts up to one year.

• Biological therapy. In high amounts, the biological substances used can be toxic and lead to persistent fatigue.

What Other Factors Contribute to Fatigue?

Tumor cells compete for nutrients, often at the expense of the normal cells’ growth. In addition to fatigue, weight loss and decreased appetite are common.

Decreased nutrition from the side effects of treatments (such as nausea, vomiting, mouth sores, taste changes, heartburn, or diarrhea) can cause fatigue.

Cancer treatments, specifically chemotherapy, can cause reduced blood counts, which may lead to anemia, a blood disorder that occurs when the blood cannot adequately transport oxygen through the body. When tissues don’t get enough oxygen, fatigue can result.

Medicines used to treat side effects such as nausea, pain, depression, anxiety, and seizures can cause fatigue.

Research shows that chronic, severe pain increases fatigue.

Stress can worsen feelings of fatigue. Stress can result from dealing with the disease and the “unknowns,” as well as from worrying about daily accomplishments or trying to meet the expectations of others.

Fatigue may occur when you try to maintain your normal daily routine and activities during treatments. Modifying your schedule and activities can help conserve energy.

Depression and fatigue often go hand-in-hand. It may not be clear which started first. One way to sort this out is to try to understand your depressed feelings and how they affect your life. If you are depressed all the time, were depressed before your cancer diagnosis, are preoccupied with feeling worthless and useless, you may need treatment for depression.

What Can I Do to Combat Fatigue?

The best way to combat fatigue is to treat the underlying medical cause. Unfortunately, the exact cause is often unknown, or there may be multiple causes.

There are some treatments that may help improve fatigue caused by an under-active thyroid or anemia. Other causes of fatigue must be managed on an individual basis. The following guidelines should help you combat fatigue.

Assessment

Keep a diary for one week to identify the time of day when you are either most fatigued or have the most energy. Note what you think may be contributing factors.

Be alert to your personal warning signs of fatigue. Fatigue warning signs may include tired eyes, tired legs, whole-body tiredness, stiff shoulders, decreased energy or a lack of energy, inability to concentrate, weakness or malaise, boredom or lack of motivation, sleepiness, increased irritability, nervousness, anxiety, or impatience.

Energy Conservation

There are several ways to conserve your energy. Here are some suggestions:

Plan ahead and organize your work

• Change storage of items to reduce trips or reaching.
• Delegate tasks when needed.
• Combine activities and simplify details.

Schedule rest

• Balance periods of rest and work.
• Rest before you become fatigued — frequent, short rests are beneficial.

Pace yourself

• A moderate pace is better than rushing through activities.
• Reduce sudden or prolonged strains.
• Alternate sitting and standing.

Practice proper body mechanics

• When sitting, use a chair with good back support. Sit up with your back straight and your shoulders back.
• Adjust the level of your work — work without bending over.
• When bending to lift something, bend your knees and use your leg muscles to lift, not
your back. Do not bend forward at the waist with your knees straight.
• Carry several small loads instead of one large one, or use a cart.

Limit work that requires reaching over your head

• Use long-handled tools.
• Store items lower.
• Delegate activities when possible.

Limit work that increases muscle tension

• Breathe evenly; do not hold your breath.
• Wear comfortable clothes to allow for free and easy breathing.

Identify effects of your environment

• Avoid temperature extremes.
• Eliminate smoke or harmful fumes.
• Avoid long, hot showers or baths.

Prioritize your activities

• Decide what activities are important to you, and what could be delegated.
• Use your energy on important tasks.

How Does Nutrition Impact Energy Level?

Cancer-related fatigue is often made worse if you are not eating enough, if you are not eating the right foods, or are otherwise lacking in the nutrients your body needs. Maintaining good nutrition can help you feel better and have more energy. The following are strategies to help improve nutritional intake:

1. Meet your basic calorie needs. The estimated calorie needs for someone with cancer is 15 calories per pound of weight if your weight has been stable. Add 500 calories per day if you have lost weight. Example: A person who weighs 150 lbs. needs about 2,250 calories per day to maintain his or her weight.

2. Get plenty of protein. Protein rebuilds and repairs damaged (and normally aging) body tissue. The estimated protein needs are 0.5-0.6 grams of protein per pound of body weight. Example: A 150-pound person needs 75-90 grams of protein per day. The best sources of protein include foods from the dairy group (8 oz. milk = 8 grams protein) and
meats (meat, fish, or poultry = 7 grams of protein per ounce).

3. Drink plenty of fluids. A minimum of 8 cups of fluid per day will prevent dehydration. (That’s 64 ounces, 2 quarts or 1 half-gallon). Fluids can include juice, milk, broth, milkshakes, gelatin, and other beverages. Of course, water is fine, too. Beverages containing caffeine do NOT count. Keep in mind that you’ll need more fluids if you have treatment side effects such as vomiting or diarrhea.

4. Make sure you are getting enough vitamins and minerals. Take a vitamin/mineral supplement if you are not sure you are getting enough nutrients. A recommended supplement would be a multivitamin that provides at least 100% of the recommended daily allowances (RDA) for most nutrients, though sometimes even this is not enough as every person’s absorption of nutrients is different - consult your practitioner for individual advice. Note: Vitamin supplements do not provide calories, which are essential for energy production. So vitamins cannot substitute for adequate food intake.

5. Make an appointment with a dietitian. A registered dietitian provides suggestions to work around any eating problems that may be interfering with proper nutrition (such as early feeling of fullness, swallowing difficulty, or taste changes). A dietitian can also suggest ways to maximize calories and include proteins in smaller amounts of food (such as powdered milk, instant breakfast drinks, and other commercial supplements or food additives).

How Does Exercise Impact Energy Level?

Decreased physical activity, which may be the result of illness or of treatment, can lead to tiredness and lack of energy. Scientists have found that even healthy athletes forced to spend extended periods in bed or sitting in chairs develop feelings of anxiety, depression, weakness, fatigue, and nausea.

Regular, moderate exercise can decrease these feelings, help you stay active and increase your energy. Even during cancer therapy, it is often possible to continue exercising.

Here are some guidelines to keep in mind.

• Check with your doctor before beginning an exercise program.
• A good exercise program starts slowly, allowing your body time to adjust.
• Keep a regular exercise schedule. Exercise at least 3 times a week.
• The right kind of exercise never makes you feel sore, stiff, or exhausted. If you experience soreness, stiffness, exhaustion, or feel out of breath as a result of your exercise, you are overdoing it.
• Most exercises are safe, as long as you exercise with caution and don’t overdo it. The safest and most productive activities are swimming, brisk walking, indoor stationary cycling, and low impact aerobics (taught by a certified instructor). These activities carry little risk of injury and benefit your entire body.

How Can I Manage My Stress?

Managing stress can play an important role in combating fatigue. Here are some suggestions that
may help.

1. Adjust your expectations. For example, if you have a list of 10 things you want to accomplish today, pare it down to 2 and leave the rest for other days. A sense of accomplishment goes a long way to reducing stress.

2. Help others understand and support you. Family and friends can be helpful if they can “put themselves in your shoes” and understand what fatigue means to you. Cancer groups can be a source of support as well. Other people with cancer understand what you are going through.

3. Relaxation techniques such as audiotapes that teach deep breathing or visualization can help reduce stress.

4. Activities that divert your attention away from fatigue can also be helpful. For example, activities such as knitting, reading or listening to music require little physical energy but require attention.

If your stress seems out of control, talk to a healthcare professional.

When Should I Call my Doctor?

Although cancer-related fatigue is a common, and often expected, side effect of cancer and its treatments, you should feel free to mention your concerns to your doctors. There are times when fatigue may be a clue to an underlying medical problem. Other times, there may be treatments to help control some of the causes of fatigue.

Finally, there may be suggestions that are more specific to your situation that would help in combating your fatigue. Be sure to let your doctor or nurse know if you have:

• Increased shortness of breath with minimal exertion
• Uncontrolled pain
• Inability to control side effects from treatments (such as nausea, vomiting, diarrhea, or loss of appetite)
• Uncontrollable anxiety or nervousness
• Ongoing depression

Basis article reviewed by the doctors at The Cleveland Clinic Taussig Cancer Center. Edited by Cynthia Haines, MD.