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    When Supplements "Work". . .EZVille, Ltd - Where Health & Safety Are Important-ish
    By Josh Witten | August 10th 2010 09:15 AM | 8 comments | Print | E-mail | Track Comments
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    Welcome to the home of the rugbyologist. Come along as I wander far and wide (and near, too), stop to smell the roses of intellectual fancy, and...

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    The Universe is a funny place, full of bizarre coincidences. What are the odds that a dietary supplement would, by chance, contain a regulated drug that treats exactly the same condition that the supplement claims to treat?

    This week we get a double whammy from EZVille, Ltd. EZVille, Ltd. has issued a recall of Revivexxx (one guess what that is supposed to "revive") and Solo Slim. Revivexxx is a male sexual enhancement supplement (DSHEA code for treating erectile dysfunction), which was found to contain the erectile dysfunction pharmaceutical tadalafil (marketed using a series of creepy commericals under the brand name Cialis). Tadalafil is known to have potentially dangerous interactions with medications containing nitrates, such as those taken for heart disease. Solo Slim is a weight loss supplement, which was found to contain the appetite suppressant didesmethyl sibutramine. Sibutramine can increase blood pressure and heart rate putting individuals at risk for stroke and other cardiovascular issues at greater risk.

    Individuals for whom tadalafil and sibutramine are not viable therapeutic options due to interacting medications or underlying medical issues may be more likely to seek out these alternative products to avoid side effects. The undeclared presence of these drugs in these supplements exposes these "at risk" individuals to these potentially dangerous side effects without their knowledge, unarguably a worse situation than if they had knowingly been prescribed these medications under the observation of a trained health care professional.

    On 6 August 2010, EZVille, Ltd. issued two press releases (Revivexxx and Solo Slim) announcing the recalls. Despite the safety implications of these undeclared drug ingredients, the EZVille, Ltd. websites present no information about the undeclared drug ingredients or the recall (screen capture images are at the bottom of the post). Instead, there seems to be less information available than before. The text of an email sent to EZVille, Ltd. inquiring about their efforts to inform customers of this important health issue is below.
    TO: Eric Budnzinski (ericb@ezville.com)

    SUBJECT: Information on Revivexxx and Solo Slim Recalls

    Dear Mr. Budzinski,

    As a concerned parent and consumer, I subscribe to the US Food&Drug Administration's MedWatch service and was distressed to see that EZVille, Ltd. is issuing voluntary recalls for two of its products (Revivexxx and Solo Slim) due to the presence of undeclared drug ingredients (tadalafil and didesmethyl sibutramine).

    I am sure that you are aware that these drugs can have potentially dangerous side effects for individuals with particular health conditions or who are taking other medications with which these drugs might have negative interactions (such as nitrates with tadalafil). Due to these side effects and drug interactions, individuals with these condition or on such medications may be more likely to seek out alternative treatments for conditions, like erectile dysfunction and weight loss, to avoid the effects caused by the very drugs that have been found in EZVille, Ltd's products.

    Given EZVille, Ltd's laudable concern for the health and safety of its customers:

    "EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers."
    I am curious about the lack of information about these recalls or the detection of these drugs in EZVille, Ltd's products on either the EZVille, Ltd website or the individual product websites. Revivexxx pages are empty or state "there are no products to list in this category". The Solo Slim website makes no mention of a recall or drug ingredients, except to mention that the product is not currently available without explanation. I will be happy to provide screen capture images of the relevant sites, if this would be helpful.

    Where would a consumer who does not subscribe to the FDA MedWatch emails learn about this recall? Have consumers who made internet purchases been contacted? How are you contacting consumers that purchased these products in stores?

    The press release is dated 6 August 2010. It is now 10 August 2010. While some alterations have been made to EZVille, Ltd websites, these changes do not inform consumers about the recall or the issues involved in the recall. For an issue that affects "the health and safety of consumers", the lack of positive action to inform current and potential customers of this situation suggests that EZVille, Ltd may not be sufficiently concerned with "the health and safety of consumers".

    Sincerely,
    Josh Witten
     


     

    Keep you and yours safe. Subscribe to the FDA Medwatch Alerts.

    *Front page image by rodrigo senna (CC 2.0)

    Comments

    I agree with you, thanks Josh! "The undeclared presence of these drugs in these supplements exposes these "at risk" individuals to these potentially dangerous side effects without their knowledge, unarguably a worse situation than if they had knowingly been prescribed these medications under the observation of a trained health care professional."

    Well, how else are these herbal snake oils supposed to work if there's not an actual medicine in it?

    kerrjac
    Well, instead of worrying about the dangers of supplements, perhaps we should worry more about the efficacy of safe drugs that have already been approved. This week the FDA threatened to pull midodrine, a drug that has been sold since 1996 when it was put on fast-track approval; its maker had already decided to scale back production because additional requested clinical trials would cost it about $25 million, when it's only making about $500,000 on it per year. Further complicating things is that generic versions had already been approved, so there's no point in conducting clinical trials when you won't get exclusive rights. (Why would you even consider approving generic production of a drug that was approved on a conditional basis for life-threatening/severe conditions?)

    Suffice it to say, the drug is very simple, has a safe record, and - impartiality aside - I've depended on it for the past 3 years, and my main alternative is a type of corticosteroid which doesn't work as well and has a lot more side effects. 

    The problem with the FDA is a lack of focus. The supplements industry is so big for a very specific reason: There is a demand for chemicals with specific drug-like effects that can be marketed without running huge clinical trials. Estimates place supplements a $60 billion industry. Markets for supplements like those above are so huge because there is a huge barrier for new drugs to enter the market. That's why the most successful drugs are only those for which there is a huge - rather than modest or niche-like - demand.

    The focus should be primarily on safety first, and efficacy second, reaching a balance when both the risks and rewards are high. In order to address the wild supplements industry, it's more effective to look at why it is the way it is, and not at individual companies on a case by case basis. The latter is expensive, slow, and it's what the beauracracies like to do.

    jtwitten
    Interesting points about the regulations surrounding drug development and marketing. The importance of worrying about the dangers of supplements is directly a part of this regulatory issue. DSHEA does not require supplements to undergo any testing (forget about expensive RCTs) before going to market. This regulatory framework creates a situation where at-risk consumers are being exposed to pharmaceuticals without their knowledge, because the products are only checked for safety and ingredients after they are on the market.

    One can debate the best way to test and approve drugs, as long as consumers/patients are provided with enough accurate information to make informed choices, even bad ones.
    kerrjac
    Good point, but when you look at an industry as a whole, you have to question the utility and feasibility of testing every single product along multiple dimensions. 
    Toy companies are not required to test / report the fun factor for each product - and yet they make audacious claims about them; and Microsoft does not test / report how efficient Office Suite will make me at work, and yet claim that it will make me more productive...both at work and at home.

    The point is that if you take an industry in which there is high demand, you can impose tough regulations on which products come to market, but the demand is going to remain, and it will likely spill over into some other market. Doctors, health care, and prescription drugs are already highly regulated, and so demand has spilled over into a less regulated sector, supplements. If you place tough restrictions on supplements, people will go elsewhere - maybe to black markets, maybe to making their own drugs, or maybe, if we're talking weight-loss supplements, to exercise programs, the latter of which are healthy, but, once again, unregulated and are allowed to make bold claims.

    Regulations need to work with markets rather than against them. Rather than having the unrealistic goal of verifying every statement a company makes about its products, they should first ensure a basic level of consumer safety. Focusing too heavily on the former will create new industries which are both unsafe and untested.
    Prescription drugs and herbal supplements both have a place in the market. I for one would rather use supplements for certain things seeing as how whenever a new drug comes out of the market you get a 45sec commercial where 15 seconds talk about the product, and the next 30 seconds describes all the side effects ranging from abdominal pain to thoughts of suicide???, to liver damage and more.
    Its funny how when I look up Didesmethyl sibutramine it is considered a regulated drug by the FDA but you cannot find a web page that has a drug listed containing this ingredient. However, Sibutramine hydrocloride is an FDA approved drug in the prescription diet pill Miridia. Look this one up on drugs.com and it gives you all the safety concerns and side effects, but no where does it mention it may cause heart attack and stroke, although it does say that it is beneficial to overweight individuals with high blood pressure and cholesterol. How, if the FDA acknowledges that Sibutramine can cause high blood pressure and stroke does a prescription diet pill with this in it not state this warning! Instead it recommends it for people who are already at high risk for heart attack and stroke...hmmm, could money be in the picture here? At least SoloSlim warns not to take their product if you have heart conditions without consulting a doctor.
    And as for the doctor prescribes these medications and can monitor the patient. Unless he goes home with his patients and keeps them on monitors day and night, what is he gonna do if the prescription he put his patient on causes an adverse reaction and triggers a heart attack? Anyway, I'll get off my soap box now, just find it funny everyone is quick to jump on supplements when prescriptions seem to be a lot worse in most cases. Very few supplements have any side effects!

    jtwitten
    A responsible and competent doctor considers the relative risks and benefits of a treatment given a patient's individual situation. The information required to make such judgments is available, although not as easily accessible to the public as it should be. If one does not know the ingredients in a treatment, one cannot use the available information to inform that judgment.

    Your complaint regards the regulation of drug labeling and advertising. There is is a world of difference between compliance with poor regulations and selling a product that falsely represents its ingredients, especially when one increases risks to consumers.

    While your critiques may tarnish the position of the pharmaceutical industry, they do nothing to improve the position of SoloSlim. 

    Most supplements have no side effects because they have little or no physiological activity.
    i want to known whether high calcium diet can induce weight loss.
    Thank you