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FDA Hands-Off On St. John's wort Cataract Connections (Part 3)

By Jane Akre

What's a Consumer To Do?

LEARN MORE IB News - St. Johns wort, The Cataract Connection – December 2009 IB News – Emerging Doubts About the Safety of St. John's wort (Part 2)– December 2009 HerbalGram – Herbal Supplement Sales Experience Slight Increase in 2008 – Spring 2009 Current Eye Research – Abstract – October 2009 FDA Public Health Advisory- St John's wort- 2000| Fordam University – on St. John's wort and sun exposure, 2003 Center for Science in the Public Interest – on St. John's wort NIH- on St. John's wort American Academy of Family Physicians – on St. John's Wort studies National Center for Complementary and Alternative Medicine – on St. John's wort InjuryBoard Help Center – St. John's wort

IMAGE SOURCE: Indigenous Remedies Web site/ St. John's wort image

Since the mid 1990s, St. John's wort (SJW) has become one of the most prescribed herbal preparations for the treatment of depression.

Its reputation as an antidepressant was established in Germany where it is considered a first-line remedy, prescribed more often than Prozac or Zoloft.

And despite less than stellar results from U.S. clinical trials, Nutrition Business Journal puts it among the Top 10 best selling herbal dietary supplements, raking in about $8 million in U.S. sales in 2008.

All of that good news worries chemist, Dr. Joan Roberts.

Her work at Fordham University, where she is considered an expert in the effects of UV radiation and visible light on the eye, has shown that in the lab one component of SJW, hypericin, damages the ocular lens in the presence of visible light.

In humans that can mean cataracts and irreversible macular degeneration from a damaged retina. But her findings had not been seen in a human population until now.

Last October, researchers from the University of Alabama, published their results in Current Eye Research, finding more than 31,000 people who reported cataracts, were 59% more likely to report SJW use over the past 12 months.

Dr. Roberts is concerned the effects of this wonder herb might take ten years to filter to the public, enough time for cataracts to form. (See Interview with Dr. Roberts – Part 2)

"I support complementary medicine and natural alternatives to prescription drugs. However, the herbs and over-the-counter drugs need to be safe as well as effective,' she tells IB News.

So how can a consumer know about the cataract connection to SJW? Look on the federal Web sites and you come up empty.

The National Center for Complementary and Alternative Medicine, a federal arm of the National Institutes of Health, reports SJW may cause increased sensitivity to the sunlight, as it has been linked to rashes.

On the FDA's Web site, the only warning is a 2000 Public Health Advisory warning of drug interactions with St. John's wort and indinavir, a drug used to treat AIDS patients.

Siobhan DeLancey, an FDA spokeswoman, tells IB News the problem may be with nature of dietary supplements themselves.

The FDA relies on adverse event reports and typically that happens when someone takes a prescription drug and then breaks out in hives. But with over-the-counter drugs and dietary supplements, the consumer may not connect the dots.

'It's passive surveillance and there can be a delay in reporting,' DeLancey says.

And you can thank a 1994 regulation that largely put industry in charge of itself.

DSHEA

The FDA regulates supplements through the Dietary Supplement Health and Education Act of 1994, or DSHEA, which treats dietary supplements like food, not drugs, with a largely hands-off attitude.

DSHEA was born from public outcry after FDA agents, armed and wearing bulletproof vests, burst into a Tahoma, Washington clinic in May 1992 to stop practitioners of alternative medicine from using injections of vitamins, minerals and amino acids. The raid was later broadcast on news programs. It was all part of an increased effort to stop manufacturers of nutritional supplements from making unproven claims for their products unless first approved by the agency.

But the agency backed off after it suffered a public black eye and the supplement industry grew in popularity and lobbyists, becoming the $25 billion industry it is today ($5 billion in herbal dietary supplements) serving about 200 million Americans who regularly consume dietary supplements.

Safety Loopholes

By law, the manufacturer is responsible for ensuring the safety of its products before they are marketed. The manufacturer is required to record, investigate and forward to the FDA any 'serious' adverse events associated with the use of the dietary supplement.

What is considered 'serious'? That is up to the manufacturer.

DSHEA gives the FDA responsibility for taking action against any unsafe dietary supplement product after it reaches the market and finds the dietary supplement is 'unsafe' or if a 'new' ingredient, not sold in the U.S. prior to 1994, is added.

'A number of factors can trigger a review--the severity of the adverse events, the number of adverse events received, and how conclusively the product can be linked to the condition are all key facets,' the FDA's DeLancey tells IB News.

After Congress gave FDA even more authority to remove from the market, recalls and seizures followed.

Banned in April 2004, ephedra, also known as ma huang, or Mormon Tea, was associated with concerns about irregular heartbeat, seizures, heart attack, stroke, or death. U.S. Marshalls pulled bottles containing ephedra off the shelves in February and November 2004.

Consumers were warned not to buy or eat three red yeast rice products sold on the Web, in August 2007, because the active pharmaceutical agent lovastatin, is the same ingredient in the prescription drug, Mevacor, marketed for treating high cholesterol.

More recently, supplements for weight loss, high cholesterol, body building, and sexual enhancement have flooded the market.

In May 2009, the FDA seized $1.3 million in body-building supplements with unapproved additives including steroids, reports Consumer Reports. Then in April, 30 weight loss dietary supplements were recalled because of the link between Hydroxycut and serious liver injuries.

'Slim Waist Formula,' '21 Double SLIM' and '24hours Diet' were found to illegally contain sibutramine, a drug which is the active ingredient in the prescription weight-loss medication Meridia.

While the majority of supplement makers self-regulate responsibly, the weight loss, body building, athletic and sexual enhancement makers have shown a disproportionate number of recalls and seizures.

With the FDA charged with policing companies that account for 25 percent of the U.S. economy – is there enough enforcement? It depends on who you ask.

A recent editorial in the Boston Globe cites a New England Journal of Medicine study that claims contamination has been identified in over 140 products, including metals, prescription drugs and toxic plant material.

But ask those inside the industry and you get another perspective. Vitamin and mineral giant, General Nutrition Center, believes the industry is highly regulated.

Spokeswoman for GNC, Laura Brophy, tells IB News in an e-mail, 'GNC disagrees with your premise that the FDA does not regulate dietary supplements. To the contrary, the dietary supplement industry is highly regulated by the FDA under the authority given to hit by the Dietary Supplement Health and Education Act of 1994. GNC follows industry standards on formulation, manufacturing and labeling of our products.

Regulation – A Slippery Slope

Dr. Ray Sahelian is a Santa Monica, California based complementary/ alternative medical doctor who says regulating dietary supplements would require you to label foods such as bilberry, garlic, ginger, turmeric, cinnamon, and drugs Tylenol and aspirin.

After a conversation with IB News, Dr. Sahelian added a warning to his Web site about the cataract controversy.

His recommendation – rotate herbs used for depression, perhaps seasonally, giving the body a break from SJW. Instead use Sam-e and 5-HTP, which is a serotonin precursor.

Mark Blumenthal of the American Botanical Council says there is no more reason to take SJW off the market then there is to take grapefruit off the market. 'Both are known to interact with numerous conventional medicines, but in different directions: grapefruit increases the serum concentration and activity of many drugs, SJW lowers them.'

Instead, he says a better system is to look at Germany which treats SJW as a drug, evaluates the contents before its marketed to make sure the label matches what's inside the bottle, and does extensive post-marketing surveillance.

The FDA is currently collecting adverse events, and Dr. Dan-Ning Hu, a professor at the New York Eye and Ear Infirmary plans to survey patients with cataracts and macular degeneration to see if there is a link to St. John's wort use.

Consumer Action

In the meantime, consumers must become their own advocate.

Consumers can seek a mark of quality – the U.S. Pharmacopeia's USP Verified mark, which assures the user the product has the declared amount of ingredients stated on the label, does not have contaminants, and has passed quality measures.

Taking SJW for depression? Dr. Joan Roberts says find some other form of depression therapy, for instance 'Light Therapy' for seasonal depression. Never mix "Light Therapy" with SJW she says.

Wearing a hat or wraparound sunglasses will not slow the effect of damage to the eye through a light induced reaction. Just as the sun causes sunburn to your skin, the damage to the lens and retina is not painful. The damage will not show up until it's too late.

Ultimately labels should be very strongly worded, says Dr. Roberts.

'Right out the label should say it may cause blindness in the presence of light sunlight or artificial light. I would label it like cigarettes, nothing hidden or subtle, that doesn't scare anybody.'

Dr. Gerald McGwin, the epidemiologist from the University of Alabama, who uncovered the correlation between SJW and cataracts in humans, sees labeling as a slippery slope.

'I'm not suggesting people shouldn't be warned, but to be put on this product for this condition opens up a can of worms, I'm not sure we have the ability to monitor,' he says.

He instead puts it more simply.

'If they are not having their eyes examined regularly they should.' #

Originally posted at Jane Akre

Full post as published by InjuryBoard on December 14, 2009 (boomark / email).