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

Posted by Jane Akre
Tuesday, December 15, 2009 12:11 AM EST
Category: Protecting Your Family
Tags: St. John's wort, Hypericin, Cataracts, Ocular Lens, Macular Degeneration, University of Alabama, FDA, Depression, SSRI, Prozac

St. Johns wort is largely regulated by the community that makes it and is slow to react to adverse event reports connecting its use to cataracts.

What’s a Consumer To Do?

LEARN MORE

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.” #


8 Comments

Anonymous User
Posted by chris
Tuesday, December 15, 2009 2:42 AM EST

You folks at the "InjuryBoard.com are really working overtime to get something going for yourselves here. Like a class action suit. The problem is that Doctor Roberts hasn't got anything scientifically substantial for you to connect St. John's and cataracs. She didn't have it 10 years ago and she doesn't have it now. This is why the FDA isn't interested. OR THEY WOULD BE! I personally have trust in the FDA Than I do you.

Posted by Marc Ullman, Esq.
Tuesday, December 15, 2009 10:52 AM EST

Jane Akre's article is rife with mistakes that could have been avoided with even a minimal amount of research -- but that would have caused her to digress from the point she was trying to make.

Rather than do all of her research for her, I'll point out just one obvious falsehood: the claim that the Dietary Supplement and Nonprescription Drug Consumer Protection Act does not define what constitutes a serious adverse event. The reality is that both "adverse event" and "serious adverse event" defined by law.

An "adverse event" is "any health-related event associated with the use of a dietary supplement that is adverse." Section 761(a)(1) of the FD&C Act (21 U.S.C. 379aa-1(a)(1)).

A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States. See section 761(a)(3) and (b)(1) of the FD&C Act (21 U.S.C. 379aa-1(a)(3), (b)(1)).

If anyone really wants to understand what the Adverse Event Reporting Law is really all about, you can check out FDA's Guidance Document here:
LINK

Until Ms.Akre takes the time to read the laws that she is writing about, if I had an actual personal injury claim relating to a dietary supplement, I would think carefully about who I would want as my Counsel.

Posted by Jane Akre
Tuesday, December 15, 2009 12:20 PM EST

Mr Ullman-

I wondered why all the shots at the story and the assumption that I have taken a position, then I see you are a partner in a law firm that represents the dietary supplement industry. That makes sense.

Your comments underscore the battleground between the billion dollar supplement industry, which is largely made up of responsible individuals committed to producing a quality product, and the calls to regulate the fly-by-night operators who promote weight loss/ fat burning/ muscle enhancing/ for a quick financial fix.

So I'll take your position into consideration.

As far as your criticism about regulation, my job as a journalist is to translate industry jargon, accurately.

While as a lawyer it might be helpful to cite FD&C Act (21 U.S.C. 379aa-1(a)(1), my research has found that adverse events are supposed to be reported to the FDA, but as one FDA insider told me,

"Manufacturers are required to provide us with adverse events of a “serious” nature. However what is considered serious is really up to the manufacturer."

So while the laws are on the books, they are not necessarily enforced. It's the same situation with medical devices, as there is no requirement for a doctor to report an adverse event to the FDA. It's suggested, but not enforced.

I'll write you directly to see if you have any specific error to correct. I'm always glad to hear from experts in an area to make the report as accurate as it can possibly be.

I can assure you, as a consumer of vitamins and shopper at my local health food store, I'm sympathetic to the issue.

In the meantime, I agree with you- I wouldn't call me to be your Counsel either! I'm not a lawyer.

Thanks for writing and I look forward to hearing more from you!

Posted by Marc Ullman
Tuesday, December 15, 2009 12:28 PM EST

Jane,

You can start by checking out the FDCA's definition of adulterated and misbranded as well as the strict criminal liability provisions of the law (all of which were there before DSHEA and are still on the books as of this minute). Then you'll have some context for passing judgment on the regulatory framework under which supplements are sold in the United States.

With that information, you might consider whether the real issue is with lack of enforcement from FDA against rouge manufacturers and marketers that ignore the law or if, as you suggest, with mainstream industry that you attempt to depict as marketing dangerous products that should cause consumers to run to the personal injury bar that you support.

Posted by Jane Akre
Tuesday, December 15, 2009 1:23 PM EST

Marc-

Did you have your kelp flaxseed cereal this morning?

What you are referring to is the Food Drug & Cosmetic Act (“FDCA”) that establishes a premarket enforcement process. The cost and burden is placed on the manufacturer to establish safety and efficacy.

However, the FDCA requires less regulatory protection over foods and dietary supplements. For these products, the FDA has to prove a dietary supplement (DS) is adulterated or misbranded before removing it from shelves.

Cheerios is a recent example of a food that is making claims without going through premarket approval.

So - the story does not imply or state that mainstream industry is intentionally putting out a dangerous product. As science emerges would you rather keep it secret and out of the public eye so consumers cannot make an informed decision?

As someone who works in the public interest, I can't justify that position- can you?

Posted by Marc Ullman
Tuesday, December 15, 2009 1:38 PM EST

Jane,

Your resort to ad hominem attacks says it all about the intellectual honesty of your position.

As hard as it may be, let me try and educate you just a little. DSHEA amended Title 21 of the United States Code, which is the Federal Food Drug and Cosmetic Act, so your comment about "premarket enforcement" doesn't make any sense.

The FDCA creates a premarket process for new drugs, and new drugs only. There is no such process for what the law considers "old drugs". Aspirin is a good example of an "Old drug". (Jane, isn't hard to believe that so many Americans are unwittingly taking a drug like aspirin that has not undergone premarket approval?)

OTC products are marketed under a monograph system - many of which are not final and continue to be subject to revision. One example is the sunscreen monograph. (Yes Jane, sunscreens are considered drugs, but they have not undergone any premarket approval process).

Foods, of which dietary supplements are a subset, do not have a premarket approval mechanism for structure/function claims. There are premarket approval requirements for health claims. (You can read about all this on the FDA website).

As for the public interest, please do not try and wrap that self righteous cloak around yourself. Your writings make it clear that you work to support PI lawyers trying to gin up litigation to support their practices.

Posted by Jane Akre
Tuesday, December 15, 2009 1:47 PM EST

Marc-

Care to answer the questions posed in the last two paragraphs of my previous post?

As science emerges, as it does and research makes new discoveries about diet and health - doesn't the public have a right to know? Should we keep it a secret?

An informed consumer is the best one, I hope you'd agree.

Posted by Marc Ullman
Tuesday, December 15, 2009 1:54 PM EST

Jane,

Of course I agree. That's one of the reasons I do pro bono work for the Natural Products Foundation on its self-regulatory Truth in Advertising initiative.

Now I have one for you:

Do consumers deserve to have authors understand that statutory framework that they are writing about?

Cheers.

Marc

Comments for this article are closed.

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