Why alternative medicine should be regulated.

Discussion in 'General Health & Wellness' started by gapsych, Jun 24, 2009.

  1. gapsych

    gapsych New Member

    I found this editorial in the "World News and Business Report"

    Throw Out Your Zicam, and Rethink Other Alternative Cold Remedies
    June 16, 2009 04:23 PM ET | Deborah Kotz | Permanent Link | Print

    Today the Food and Drug Administration announced that we should no longer use a popular over-the-counter cold remedy—Zicam Cold Remedy Nasal Gel and Nasal Swabs—because it could cause a long-lasting or permanent loss in our sense of smell, a condition called anosmia.

    The FDA says it has received more than 130 reports from Zicam users who said their ability to smell became impaired—in some cases, after using the product only once. It goes without saying that we need our noses to, say, smell smoke when there's a fire, milk when it's rancid, and significantly enhance the taste of our food.

    Zicam's website is still up and running, with no mention, as yet, of the warning letter that its manufacturer, Matrixx Initiatives, received from the FDA. The agency told the company to stop marketing Zicam unless it applies for a formal drug approval. Matrixx Initiatives responded to my inquiry with an E-mailed statement, which reads, in part:

    Based on the FDA's action, the company has suspended shipments of these products and will reimburse any customer desiring a refund. However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products.

    Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data.

    On a personal note, I'm happy I forgot about the Zicam nasal swabs sitting in my medicine cabinet when I first caught a nasty cold a few days ago. My mom encouraged me to try the homeopathic product years ago, swearing that it cut down on the severity of her colds. I've swabbed my nose a few times and didn't notice any sign that it worked. Still, every time she hears that I'm coming down with a cold, she hounds me to use it. (She's in Europe now, so she couldn't pester me this time; hence, I forgot.)

    But I have to admit that I didn't really worry about the safety of Zicam even if I wasn't sure of its effectiveness. And many Americans felt the same way. A government survey last December found that 38 percent of people use some type of complementary or alternative remedy. Women, in particular, use alternative remedies: 43 percent of us compared with 34 percent of men.

    But as the FDA warning letter reminds us, alternative remedies aren't approved as drugs. They don't have to pass through the regulatory hoops that prove drugs' safety and effectiveness. Thus, we have no idea when we buy alternative remedies like Zicam whether we're wasting our money or, worse, putting ourselves at risk.

    So I've got three things on my to-do list for today: Throw out my Zicam when I get home. Send my mom an E-mail telling her to chuck her own stash when she returns. And throw out any other "remedies" in my cabinet that aren't regulated as drugs.
  2. TwoCatDoctors

    TwoCatDoctors New Member

    It will take 6 weeks to get back toxicology on Michael Jackson so it's a bit early to be coming to conclusions about his death. One sports player was just recently involved in the use of a female hormone, but I'm not going to say the medication is no good, but instead I believe the medications and supplements are both good and useful, but best regulated.

    A few months back I posted about the TV show The Doctors discussing the death of the woman from using Ginkgo Biloba--she should not have been taking it. And on the other board we just discussed how St. John's Wort should be told to all doctors in case of surgery. It scared me on the other board when someone re-printed a post from the Fibro board and included it and it indicated the person was popping the supplement "like popcorn" (the original poster's post). I cannot fault the supplements, but I fault the conception that supplements are always safe and I fault the manufacturers for not having to label their products accurately and not producing a product that is consistent no matter what brand you buy.

    I think it would be best to regulate the supplements so they are produced uniformly by all companies, clearly labeled as to what medical conditions they should NOT be used with, and people understand the need to be careful with them and to seek professional help (there are naturalists and others that will help you as to what would be helpful to take and what amounts you should take) so the supplements don't interfere with your conditions or medication you may be taking. The pharmacist carefully reviews prescriptions to make sure they do not conflict, but as of yet we do not have that to include supplements and I think it supplements should be included on your pharmacy list with your prescriptions.

    Whatever we take, we must be careful and let all doctors that see us know about it, and we must make sure we don't abuse what we take, whether medication or supplements.


    [This Message was Edited on 06/27/2009]
  3. Janalynn

    Janalynn New Member

    I agree wholeheartedly that there should be some regulation.

    Also this is the first time I've heard someone that takes supps regulary and promotes say "can kill TOO".
    The problem (for me) is that at least prescription meds have to be prescribed, go through rigorous testing, research etc. - hence the regulation. Yes people can and do abuse or have other complications.
    When people are recommending supplements to others they are sometimes recommending doses that may or may not be safe for that other person. They CAN hurt you if you take too much of any one thing. My Doc is all for my trying different things, but has warned me that of that.

    Regarding Zicam - my son is bummed out that it's being taken off the market - he used it every time he felt a cold coming on. You really have to take it right away. He thought it helped him. Now of course, who knows, that cold could've lasted only a shorter amount of time anyway. I also believe in the placebo effect for some supplements.
    My co-worker takes handfuls of supplements each day. He gets sicker than most of us. Kind of ironic.

    My girlfriend lost her sense of smell 20 years ago after a bad cold and taking some medication. Besides being dangerous as mentioned above, she said, it has effected her taste and sadly she misses the smell of the simplest of things - the rain, flowers, a good meal cooking on the stove and now that wonderful smell of her grandbabies.

    Bottom line- I agree (once again Gap, TwoC!) that regulation would be a wonderful change!
  4. gapsych

    gapsych New Member


    Innocuous as it seems, losing your sense of smell has horrible ramifications. This happened to my step MIL and she could not enjoy food. If you have a gas leak, you will not know. These are just a few examples.

    While I want to see regulation, I am not sure it has to be a script. I guess that would have to be determined. If the alternative world wants to be taken seriously it needs to have some kind of monitoring. Some Alt. med. practitioners are even advocating this.

    Natural does not mean there are no side effects. Many of the side effects people get on supplements are attributed to herxing or possibly some other medical condition.

    At least with conventional medicine not only are side effects monitored but it takes a lot of studying the drug to find out if it is effective.it's not just thrown out there. If a side effect is discovered later, that is fixed or consumers are warned. Even then there is no guarantee.

    Yes some meds. do have side effects. The medical profession is not perfect. However, I would rather take something that has a scientific basis than something that is a "shot in the dark".

    Supplements can be dangerous in the sense that people are self medicating and possible real medical treatment delayed. Many supplements may suggested when claims are made that are not based on how the body works.

    I take CoQ10, iron, multivitamin and fish oil. As a consumer, I want to know what I am getting is what it says on the bottle.

    Because the industry is not regulated there are a lot of quacks out there selling things that do not help or could be harmful. Some supplements do not even contain the ingredient they purport to have. Some of the fillers can also be harmful.

    Can you imagine restaurants food products such as meat and milk without any regulation"

    It has nothing to do with anyone trying "to breakdown the alternative world. It has to do with safety concerns.

    It has nothing to do with Pro Health.

    Death is natural but I do not want to die or get sick from "natural" medications.

    gap

    ETA There is a post where you can report side effects from medications. Wouldn't it be nice if the same thing was available for alt. meds.?
    <br><br>[<i>This Message was Edited on 07/02/2009</i>]
    [This Message was Edited on 07/02/2009]
  5. gapsych

    gapsych New Member


    Can you show me a study that says this? I think it is an urban legend.

    I think there are probably side effects with alternative treatments that are never reported. And it goes beyond side effects. It includes delayed treatment, quality control as well as others.

    But we will never know as there is no regulatory agency that keeps data.

    Yes there may be side effects from prescription drugs. Some disappear, some you have to weigh the benefits with the risks. Sleepiness when you first start a prescription would be counted as a side effect which would eventually disappear. At least there is a warning on some medications to not drive until you see how the medication effects you. But that does not mean you should not take it.

    Would the supposed "herxing" from alternative meds. be a side effect?

    gap
  6. TwoCatDoctors

    TwoCatDoctors New Member



    [RIGHT NOW, PER THE ARTICLE BELOW, THE FDA HAS SEIZED THE PRODUCTS OF A DRUG COMPANY BECAUSE "The recalls involved manufacturing defects, including oversized tablets and possible formulation error." THIS DOESN'T HAPPEN WITH SUPPLEMENTS AND THAT'S WHY PEOPLE BUY THEM ONLY FROM CERTAIN COMPANIES TO GET UNIFORMITY--BUT IT SHOULD BE UNIFORMITY FROM EVERY COMPANY.

    WE ALSO FORGET THAT EPHEDRA USED TO BE IN HEALTH FOOD STORES IN PRODUCTS BEFORE IT WAS PULLED OUT AND MANY YEARS AGO BODY BUILDERS WERE GETTING SOME PRETTY STRONG ALTERNATIVE STUFF IN HEALTH FOOD STORES THAT IS NOW NOT ALLOWED--MY SON USED TO TAKE IT YEARS AGO AND A DOCTOR WAS CONCERNED BECAUSE IT WAS CAUSING HORRIBLE RAGE. JUST BECAUSE IT COMES FROM A HEALTH FOOD STORE NEVER MEANS IT IS SAFE AND WE HAVE TO GET OVER THAT. ]



    FDA NEWS RELEASE

    For Immediate Release: June 25, 2009

    Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA
    U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
    FDA acts to prevent repeated drug quality problems

    U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”

    This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

    Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

    The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.

    The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.

    If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.

    "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

    Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

    To view Questions and Answers on Caraco Drugs, Including a List of Effected Drugs:
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169095.htm

    To view Facts About Current Good Manufacturing Practices:
    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

    To view the October 31, 2008 FDA Warning Letter to Caraco Pharmaceutical Laboratories, Ltd:
    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048080.htm

    FROM: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169093.htm