June 23, 2009
Zicam Reveals Holes in Drug Regulation
Would you take this pill? (courtesy of flickr use steveb_ohio)
In the United States, there are “drugs” and there are “dietary supplements.” Each are chemicals intended to improve your health, but they are held to very different standards of regulation: Before drugs can be sold, a company must prove to the Food and Drug Administration that their product is safe and effective. Dietary supplements, meanwhile, do not need approval from the FDA before they are marketed; companies do not need to prove that these substances are safe or effective before they are sold. If a supplement proves harmful, though, the FDA can ban the substance, like it did with ephedra in 2006.
The Zicam warning issued last week by the FDA reveals a little-known third class of chemicals marketed for your health—homeopathic drugs. These are technically drugs, but they do not have to go through the long approval process; they receive automatic approval from the FDA as long as the Homeopathic Pharmacopoeia Convention of the United States adds the substance to their list. No long trials, no science needed.
On its face, this shouldn’t be too much of a problem, because homeopathic drugs shouldn’t have any active ingredients in them. Yes, you read that correctly. See, homeopathy is a type of alternative medicine in which a compound is put through a series of dilutions until little, if any, of the compound remains. It has been proposed that homeopathic drugs work by “water memory,” which is a load of bunk. But at least if the “drug” doesn’t have any pharmacologically active substances left in it, then it shouldn’t have any side effects, either. The biggest risk by taking them should be that of not having taken something that would actually work.
But Zicam, which fell under the homeopathic drug label, wasn’t diluted to the point where it was indistinguishable from water. It contains biologically active levels of zinc. And it’s that zinc that is suspected to be behind reports of a decrease or loss of smell in Zicam users. The FDA has now asked Zicam’s maker to “submit a new drug application to demonstrate safety and efficacy.”
Herbal supplements and homeopathic drugs are just a couple of examples of the perils and popularity of alternative medicine. People who do not smoke, do eat organic food and drink only bottled water have no problem consuming substances that are completely unregulated, even in place of pharmaceuticals with strong trial evidence to back up their claims. Where is the sense in trying out random chemicals from unknown sources just because someone told you that it might make you feel better or lose weight or sleep more soundly?
We all want the magic cure, but it isn’t going to come from a homeopath or the herbal supplement industry or any other of the purveyors of woo. But what’s really sad is to see people, children sometimes, that modern medicine could help but who are sidetracked by this quackery.
(Hat tip: Science-Based Medicine)
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Yeah, and 20,000 Americans DIE each year from the proper use of aspirin and aceteminaphin, and homeopathics are a problem?
Allopathy or FDA regulated medicine is just one branch of medicine. Millions in China and India follow ancient systems of medicine.
For once let americans have a choice from pharmacy lobbyists who fund FDA.
Its FDA going against cheetos? remember that.
popurls.com // popular today…
story has entered the popular today section on popurls.com…
Don’t confuse mislabeling a product for the need to regulate an industry. Just like mislabeling pet food with a certain amount of protein when melamine from China was added to it to boost the % of protein in it. It was unscrupulous labeling not a loophole in the regulation.
Supplements are not drugs. They are not a new synthetic chemical or compound made from petrochemicals. That is why they don’t go through the same trials required of the big pharmaceuticals companies. Many pharmaceutical drugs are synthetic forms of herbs or the active ingredients in herbs, like digitalis from the foxglove plant.
There have been many studies done in Europe that prove the effectiveness of homeopathic remedies.
Herbs have been used for centuries, if not millennia, with many put through trials outside of the United States. The reason Pharmaceutical companies aren’t interested in them is because you can’t patent an herb. So because there are no US trials for most herbs that doesn’t make them ineffective or quackery.
The FDA needs to better control the medical and pharmaceutical industries better before they try to control an industry that doesn’t kill anyone.
“According to the groundbreaking 2003 medical report Death by Medicine, by Drs. Gary Null, Carolyn Dean, Martin Feldman, Debora Rasio and Dorothy Smith, 783,936 people in the United States die every year from conventional medicine mistakes. That’s the equivalent of six jumbo jet crashes a day for an entire year. But where is the media attention for this tragedy? Where is the government support for stopping these medical mistakes before they happen?”
“Of the 783,936 annual deaths due to conventional medical mistakes, about 106,000 are from prescription drugs, according to Death by Medicine. That also is a conservative number. Some experts estimate it should be more like 200,000 because of underreported cases of adverse drug reactions.” (http://www.naturalnews.com/009278.html)
Chemotherapy is one of the worst unproven quackery in medicine.
This from: http://www.cancerresearchinformation.com/chemotherapy-does-not-work-is-costly-has-adverse-effects-and-kills/
“Most cancer patients in this country die of chemotherapy… Chemotherapy does not eliminate breast, colon or lung cancers. This fact has been documented for over a decade. Yet doctors still use chemotherapy for these tumors… Women with breast cancer are likely to die faster with chemo than without it.” – Alan Levin, M.D.
From the same article:
In 1990, the highly respected German epidemiologist, Dr. Ulrich Abel from the Tumor Clinic of the University of Heidelberg, conducted the most comprehensive investigation of every major clinical study on chemotherapy drugs ever done. Abel contacted 350 medical centers and asked them to send him anything they had ever published on chemotherapy. He also reviewed and analyzed thousands of scientific articles published in the most prestigious medical journals. It took Abel several years to collect and evaluate the data. Abel’s epidemiological study, which was published on August 10, 1991 in The Lancet, should have alerted every doctor and cancer patient about the risks of one of the most common treatments used for cancer and other diseases. In his paper, Abel came to the conclusion that the overall success rate of chemotherapy was “appalling.” According to this report, there was no scientific evidence available in any existing study to show that chemotherapy can “extend in any appreciable way the lives of patients suffering from the most common organic cancers.”
And this:
“Many doctors go as far as prescribing chemotherapy drugs to patients for malignancies that are far too advanced for surgery, with the full knowledge that there are no benefits at all. Yet they claim chemotherapy to be an effective cancer treatment, and their unsuspecting patients believe that “effective” equals “cure.” The doctors, of course, refer to the FDA’s definition of an “effective” drug, one which achieves a 50% or more reduction in tumor size for 28 days. They neglect to tell their patients that there is no correlation whatsoever between shrinking tumors for 28 days and curing the cancer or extending life. Temporary tumor shrinkage through chemotherapy has never been shown to cure cancer or to extend life. In other words, you can live with an untreated tumor for just as long as you would with one that has been shrunken or been eliminated by chemotherapy (or radiation).”
This is just an attempt to try to discredit and regulate an industry protected by the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Yeah, cause there have never been any problems with drugs that are FDA approved.. lol..
Hmm- it sure *sounds* as if Sarah Zielinski is a shill for the drug industry.
First of all, homeopoathic medicines are not “chemicals”. A great word to use if you’re trying to alarm. Not so good if you’re trying to educate.
Second, Zicam is the company name, and the company produces almost two dozen different products. Two of those are the subject of recent news. The others are not. Not convenient it seems for Sarah to so inform her readers.
The FDA could be a worthwhile agency if it weren’t run by former heads of drug companies. They’ve been itching to prohibit homeopathy or classify homeopathic remedies as “drugs” for decades. It is a bit odd because they also hold that homeopathics are worthless and do nothing. Kind of hard to hold both positions and look credible, don’t you think? All the more difficult because homeopathic remedies are widely accepted throughout the world. Sarah neglected to remind the reader of these bits of information as well.
It might be nice for folks like Sarah Zielinski to simply allow that adults are fully capable of conducting their own affairs as informed consumers; and, stop ranting and raving about the dangers of homeopathy.
If you want the facts (as an informed consumer, something Sarah Zielinski appears loath to promote), go to Zicam.com to see a full Q&A on the company’s recent product recall.
A second note. If Sarah Zielinski is this alarmed about homeopathic remedies, I trust that she is far more alarmed about the lack of FDA regulation of perfumes and chemical treatments in clothing, which are arguably far more invasive to the general population’s immune and nervous systems that homeopathics which are taken by a small fraction of the population a small fraction of the time per year. I would love to hear from Sarah Zielinski about her concerns and frustration about the lack of FDA action on unregulated perfumes and clothing “chemicals” (over 1500 and the vast majority are toxic in small concentrations). Formaldehyde? Toluene? Bentane? Couldn’t we have a little more sensible attention to truly dangerous unregulated substances affecting vast portions of the population, Sarah Zielinski?
Hopefully this process will be amended to increase the effectiveness of the FDA.
I moved in the New Age community in my hometown for several years while I was a teenager and came in contact with everything from aura readers to chi gong practitioners to raiki healers.
The -only people- who squicked me were the homeopathic “doctors”. They were, all three of them who I knew, argumentative and egotistical. One of them bored me at a dinner party telling me stories of their miracleworking exploits, and boasted that when a mother had come in with a very sick child once, he’d looked at the child and told her to take him to the hospital. I was like: “Well, yeah. And?” He wanted me to applaud him for not trying to treat something life threatening himself. Because he’s -not a real doctor-.
I was talked into seeing a homeopath for my allergies, and he said ‘I know what’s wrong with you, it will cost $X to fix it’. I asked what was wrong, and he refused to elaborate at all. Even the aura reader would have talked about an imbalance of energies that she perceived as colors on my body. (She actually had a cool thing she did where she’d paint your aura as she saw it. Great performance art.) We ended up getting in a fight because I kept insisting that I was not going to pay to have something fixed if he could not describe what was wrong.
A lot of what I saw convinced me that while a good deal of alternative/complimentary medicine is bunk, there’s something to some of it. The only sphere that I’d flat out advise anyone to stay away from is homeopathy.
Both Sarah’s article and the responses illustrate vividly the problem. There are people who totally discount homeopathics, and those that appear to totally accept them. I have no doubt that there are effective homeopathic medicines and supplements. The problem is that there is no scientific data (or not enough) to determine which ones are effective, which may be harmful, etc. As a massage therapist and a nurse, I have been approached by numerous individuals selling the “miracle cure” for every known ill. Some may be great, but I have no way of knowing, so am reluctant (and unwilling) to recommend any of them. And it does worry me to know that people will turn to them to treat illnesses with dire consequences, when there are “drugs” out there that can help. As a nurse I am fully aware of the potential side effects of any “drug” given. But the effect of many illnesses outweigh the potential risks. Many people are successfully managed or cured using drugs, without any serious side effects. All of the “natural” substances out there are just chemicals. The fact that they occur naturally does not, in and of itself, make them not potentially dangerous. Poisons exist in nature, too. It does take a discerning adult to make the decision about what they put in their bodies. This is true of drugs, supplements, and homeopathic medicines. I wish there was a lot more research re alternative medicine practices. But until then, I urge caution for all–those taking regulated “drugs,” supplements, and homeopathic medicines. All have a potential risk.
Extremely careless report!
some FDA approved chemicals do not work well in some circumstances, ERGO a shaman with a bone through his nose dancing around you shaking rattles is medicine.
is this really difficult? don’t take any sort of medicine unless you have a demonstrated need- and in the case of remedies with zero proof of efficacy, that means NEVER
Did anyone else notice that all that fuss is being made about “biologically active levels of ZINC?” I take about 100-150 mg of zinc a day, and I can smell just the same as I’ve always done. What’s zinc got to do with anything (other than being unpatentable, and therefore profit-threatening)?
I started using the Zicam dissolvable pill yesterday when I first began feeling cold symptoms and I feel much better. Whether it’s the result of the ingredients in Zicam or a sugar pill, mind-over-matter effect, I can’t say. All I know is that it appears to have worked and I’ll use it again.
But I don’t know how much it’d help if the cold was full-blown. I suspect that in that scenario, the virus would overpower the drug.
Still, my theory’s always been to hit it hard when symptoms first show up before the cold grows strong, and Zicam appears to work to do that.
Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. Additionally, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste may unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.
FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.
There is no mistaking there is a war against the herbal approach to solving problems. Many herbs are effective and are backed by studies and trials.
Natural statins were persecuted and yanked from the market, ephedra has followed the same route despite pharmaceuticals that remain on the shelves with the same if not more powerful active ingredients.
The chinese have been using this stuff for thousands of years with no problems!!
[...] nasal sprays and gels. But the lozenges haven’t proven successful in clinical tests, and the FDA issued a warning on the nasal sprays and gels last year after users reported that the products harmed their sense of [...]
Very nice piece about how homeopathic drugs avoid any scrutiny by the FDA. I linked to it in a post I just put up today on my blog:
http://genome.fieldofscience.com/2011/06/strychnine-for-your-childs-cold.html
The same story will also appear at Forbes magazine:
http://blogs.forbes.com/stevensalzberg/