Ginkgo Under Attack, and Herbalists Bite Back

Perhaps predictably, a New York Times article raising serious questions about the safety of ginkgo biloba--and the report from the National Toxicology Program on which the article is based--are drawing heavy fire from botanical medicine practitioners and botanical products manufacturers. Below is a portion of comments released today. The bottom line is scientists and herbalists say the government report used the wrong kind of gingko in the study, and that the standard ginkgo used in products in the U.S. is safe.

An excerpt from comments by the American Botanical Council:

"On April 18, both the American Botanical Council (ABC) and the American Herbal Products Association (AHPA) issued statements referring to various limitations, concerns, and criticisms of the National Toxicology Report. Both organizations had filed public comments in early 2012 with the National Toxicology Program (NTP) elaborating concerns in the draft report that had been issued for public comment. 

Of particular interest is the fact that even by the NTP’s own language in the report, the results of the report are not to be interpreted as being related to human health. According to the authors, `The actual determination of risk to humans from chemicals found to be carcinogenic in laboratory animals requires a wider analysis that extends beyond the purview of these studies.'

ABC emphasized that the Shanghai Chinese ginkgo extract used in the two-year NTP study was not consistent with clinically tested ginkgo extracts or those standards for ginkgo extract that have been published in official compendial standards, such as national pharmacopeias. AHPA also noted that the Chinese extract was not consistent with those sold in the US market.

According to ABC’s Blumenthal, `Coverage of this subject in the New York Times will presumably result in more media outlets’ picking up this story and spreading to consumers and health professionals, creating what are probably unwarranted concerns about the long-term safety of appropriately manufactured ginkgo extracts.'

In addition, added Blumenthal, the Times’ statement that `Studies have never found any solid evidence that ginkgo [provides any benefit to ‘boost memory’ and ‘prevent dementia’]' is misleading. Blumenthal noted, as he had discussed with the reporter, that there is an impressive body of clinical evidence that the use of the leading German ginkgo extract does provide cognitive benefits to persons with mild dementia, among other noted benefits for patients with age-related cognitive impairment, including increases in quality of life."

New Doubts About Ginkgo Biloba

Millions of Americans take ginkgo biloba supplements to boost memory and prevent dementia. Studies have never found any solid evidence that ginkgo does any such thing, but it did not seem to be doing much harm.

But last month, scientists released the first government toxicology study of ginkgo biloba, which found that the extract — one of the top-selling herbal supplements in the country — caused cancer in lab animals, including an excessive number of liver and thyroid cancers, as well as nasal tumors.

Read the story at nytimes.com

Should You Get A Flu Shot In January?

By Woodson Merrell, M.D.

Update: Study Shows 90 Minute Jog Can Enhance the Power of a Flu Shot 

October is the optimal time to get a flu shot because it confers immunity (which can take a week or two after the shot) well before the flu sets in. However, in this year when flu is at epidemic levels, January is not too late as the flu season often does not start in earnest until late December or early January, and typically runs until March. The only caveat is that if you have been in close contact with someone who has the flu, or if you are feeling sick in any way--cold, sinus congestion, stomach bug, fever--you should not get a shot at that time as it could put an added stress on your immune system and could make you sicker. 

A model of the H3N2 virus, which contains strains of viruses that originate in birds, pigs and people.

A word on the effectiveness of the flu shot. Last week the CDC announced that the estimated vaccine effectiveness is 62% for the 2012-2013 vaccine based on a survey of 1,155 adults and children enrolled in a monitoring program from December 2 to January 2. That means those who got vaccinated were about 60 percent less likely to get the flu, according to CDC director, Tom Frieden. Historically, flu shot effectiveness ranges from 50%-70% (last years' shot was closer to 50%) so this year's shot offers a reasonable level of protection. But this is a big advantage compared to 0% without a vaccine.

Some groups fare better with the vaccine than others. Previous years' data show that younger people tend to be better protected by the vaccine than older people, and that people with underlying illness may be less likely to be protected.  It's far from a perfect shot, but a 60% reduction in the risk is as powerful a preventive tool as most anything we have.

To maintain immunity you need a flu vaccine every year; children tend to be better protected by the vaccine than older people.To maintain immunity you need a flu shot every year partly because the flu viruses that circulate the globe mutate over time, and also because the immunity conferred by the vaccine is only short-term, especially compared to many childhood vaccines that last for decades (and get well over 90% efficacy.) Every year in February the World Health Organization (WHO) brings together medical scientists and physicians responsible for global influenza surveillance, and they produce a report based on data from the previous months' flu outbreaks in the Northern Hemisphere (and early reports from the Southern Hemisphere, specifically Australia.) The previous years' strains are hyper-mutated in the lab with the goal of approximating the strains that will appear 6 months later. Because natural mutations work differently than in the lab, the vaccine is never 100% on target.

Another limitation in vaccine design is that current vaccines can hold only three different influenza viruses, though development of a vaccine to hold four viruses, known as a quadrivalent vaccine, is underway and expected as early as next year.

The 2012-2013 vaccine contains two influenza A virus strains (H1N1 and H3N2)) and one influenza B virus strain, but there is an additional B strain not in the vaccine that represents about 10% of current flu cases according to the CDC.

In addition, there are a number of other non-influenza viruses circulating, including respiratory viruses and a norovirus (causing vomiting and diarrhea) that make people feel almost as sick as having the flu.

Many people have a fear that the flu shot will somehow give them the flu or cause harm in some other way, and these are good questions to discuss with your family physician.

The fear that the flu vaccine will weaken your immune system, promulgated by the alternative healthcare community, is for the most part incorrect--and in a season such as this, somewhat dangerous.

The vaccine contains an inactivated form of the virus that can't give a person the flu; the most common side-effects are irritation where the flu shot was given, nasal congestion after the flu vaccine nasal spray, and occasionally brief (1-2 day), light, flu-like symptoms. 

Most flu vaccines are made with egg protein; people with egg allergies should speak with their doctor, and possibly get a skin test.However, there are a couple of caveats regarding real potential side-effects. For people who are allergic to eggs, there is potential for an allergic reaction to the egg protein used to make the flu shot. This past year a new egg-free, cell-based vaccine was approved in the U.S., but is not yet widely available. If you suspect you have an egg allergy, a skin test may be needed to determine the severity. If the skin test is only moderately positive, it's possible to get a flu shot. You may have to hang around your doctor's office for 30 minutes after getting the shot in case you have a reaction. It's also possible to give 10 percent of the vaccine in one injection to rule out a strong reaction, then the remaining 90 percent of the vaccine in a second injection. 

Even scarier is the very remote possibility of developing a non-allergic immune reaction. In 1976, there was a small risk of developing Guillain-Barre Syndrome (GBS) after receiving a Swine Flu vaccine. Since then, numerous studies have been done to evaluate if other flu vaccines were associated with GBS. According to the CDC, in most studies, no association was found, but two studies suggested that approximately 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine. This is lower than the rate of GBS in the general population, and serious complications from the flu occur with more frequency than that. Tens of thousands of people die from the flu each year.

In this year especially, when flu strains are rough, the risk-benefit equation falls on the side of getting the flu shot.

Ask your doctor for a single-dose vial to avoid mercury in your flu shot.As for the last bugaboo, mercury (known as thimerosol and used as a vaccine preservative), most vaccines are now free of the toxic heavy metal that can damage the nervous system, and is potentially most harmful to children and pregnant women. While it has been removed from pediatric and single-dose vaccines, thimerosol is still found in multi-dose-vials used to give more than one shot. Ask your flu-shot provider for a single-dose flu shot, which does not require preservative. However, between worrying about the tiny bit of mercury in a vaccine and getting this year's wicked influenza--I would chose the flu shot. If you can only find the multi-dose shot containing thimerosol, just don't eat fish for a few weeks after getting the shot to make up for any mercury.

The flu shot reduces--but does not eliminate--the chance that you will get sick from a virus this winter. In most years, for most healthy adults, my integrative approach to flu prevention is usually enough.  However, in years like this when the flu is severe--or every year for most infants, the elderly, or those with pre-existing conditions and their family members--the flu shot as part of an overall strategy for flu prevention gives a better than fighting chance of staying healthy until spring.

See Dr. Merrell's Guide to Flu Prevention

Is Your Sunscreen Protecting You From Skin Cancer? Maybe Not

This may be business as usual for the FDA, but consumers deserve better. Just in time for summer the FDA announced it will delay scheduled implementation of new sunscreen labeling rules because manufacturers said they were having a hard time meeting the deadline. Among the new stricter rules, the FDA was set to bar use of the term “broad spectrum” for products that do not meet a government test for protection against both UVA and UVB rays. It turns out sunscreen manufacturers have been riding roughshod over consumer expectations; the claims on sunscreen bottles are not tightly regulated.

While most of us think sunscreen prevents cancer, it technically prevents sunburn, which is not the only cause of sun-related skin cancer.

Sunscreen use has sky-rocketed since the 1970s--when baby oil and foil-wrapped album covers created legions of dangerously tan American teens--but as sunscreen use has increased so has the rate of incidence of the most deadly skin cancer, melanoma. And even the most common type, squamous cell skin cancer, is on the rise--representing one third of all new cancers diagnosed in the U.S.

In a review of evidence, acccording to consumer watchdog Environmental Working Group (EWG), the FDA said that the available clinical studies “do not demonstrate that even [broad spectrum products with SPF greater than 15] alone reduce the risk of skin cancer and early skin aging.”   The agency also said that it is “not aware of any studies examining the effect of sunscreen use on the development of melanoma.”  hmmmm.... this does not jibe with consumer perceptions.

Here, read about the EWG's list of good and bad sunscreens, including more on a common ingredient that may promote breast cancer.

Are you getting the SPF that's on the label? It's all in how you apply. Click here to find out how.

Click here for a look at the EWG's top rated sunscreens, and help us find the most elegant brands.

FDA Sunscreen Crackdown....continued.

So why doesn't sunscreen work? One widely recognized problem is that sunscreens encourage people to spend more time in the sun, absorbing more carcinogenic UV rays overall. But a darker issue exists: Inferior sunscreens with poor UVA protection that have dominated the market for 30 years, according to the EWG, which publishes an annual sunscreen update (Sunscreens 2012) that rates sunscreens for safety and efficacy.

While many sunscreens effectively prevent sunburn, they do not provide as strong a barrier to skin cancer. And some that contain a Vitamin A derivative called Retinyl Palmitate, may even promote skin cancer, according to documents from the National Toxicology Program, the interagency governmental program employing toxicologists and molecular biologists to evaluate the safety of chemicals in the public realm. Since this government report was made public in January 2011, the EWG has been advocating for action on Retinyl Palmitate by the FDA.

In lab tests, the NTP found that sun-exposed mice developed cancerous lesions faster when wearing cream with Retinyl Palmitate than when wearing cream without Retinyl Palmitate. According to the EWG, fully 25% of all sunscreens and cosmetics that carry sunscreen factors (SPFs) including moisturizers and foundation contain Retinyl Palmitate, essentially magnifying the so-called sunscreens' potential to cause skin cancer. Quips the EWG, "It’s an ironic twist for an industry already battling studies that have questioned whether their products protect against skin cancer."

We are fans of irony, folks, but not when it comes to sunscreen.

Ginseng Fights Fatigue in Cancer Patients, Mayo Clinic-Led Study Finds

from mayoclinic.org

High doses of the herb American ginseng(Panax quinquefolius) over two months reduced cancer-related fatigue in patients more effectively than a placebo, a Mayo Clinic-led study found. Sixty percent of patients studied had breast cancer. The findings are being presented at the American Society of Clinical Oncology's annual meeting.

Researchers studied 340 patients who had completed cancer treatment or were being treated for cancer at one of 40 community medical centers. Each day, participants received a placebo or 2,000 milligrams of ginseng administered in capsules containing pure, ground American ginseng root.

"Off-the-shelf ginseng is sometimes processed using ethanol, which can give it estrogen-like properties that may be harmful to breast cancer patients," says researcher Debra Barton, Ph.D., of the Mayo Clinic Cancer Center.

At four weeks, the pure ginseng provided only a slight improvement in fatigue symptoms. However, at eight weeks, ginseng offered cancer patients significant improvement in general exhaustion — feelings of being "pooped," "worn out," "fatigued," "sluggish," "run-down," or "tired" — compared to the placebo group.

"After eight weeks, we saw a 20-point improvement in fatigue in cancer patients, measured on a 100-point, standardized fatigue scale," Dr. Barton says. The herb had no apparent side effects, she says.

Ginseng has long been used in traditional Chinese medicine as a natural energy booster. Until this study, its effects had not been tested extensively against the debilitating fatigue that occurs in up to 90 percent of cancer patients. Fatigue in cancer patients has been linked to an increase in the immune system's inflammatory cytokines as well as poorly regulated levels of the stress-hormone cortisol. Ginseng's active ingredients, called ginsenosides, have been shown in animal studies to reduce cytokines related to inflammation and help regulate cortisol levels.

Dr. Barton's next study will look closely at ginseng's effects on the specific biomarkers for fatigue. "Cancer is a prolonged chronic stress experience and the effects can last 10 years beyond diagnosis and treatment," she says. "If we can help the body be better modulated throughout treatment with the use of ginseng, we may be able to prevent severe long-term fatigue."