Now that I have covered manufacturer seals and the lack of significant backing for them, we need to cover the supplements and the cautions put out by the National Institutes of Health.
"Supplement is a broad term that includes vitamins, minerals, herbs and botanicals," says Carol Haggans, a registered dietician and science and health communication consultant for the Office of Dietary Supplements of the National Institutes of Health.
“Herbs and botanicals are derived from plants, while other supplements may include animal sources. Vitamins are essential nutrients made up of organic compounds, while minerals are an imprecise term for certain chemical elements necessary to life, like calcium.”
"They're regulated under the umbrella of foods and are not intended to treat, diagnose, mitigate, cure or prevent disease. If something claims to do that, then it becomes a drug under FDA regulation," Haggans says.
This last statement is where things fall through the cracks of oversight. Too many claims that should bring supplements under FDA regulations go uninvestigated. The manufacturers have learned over time where the line is and don't cross the line. They leave that up to the stores to have leaflets and pamphlets available for customers making these claims. Then if a complaint is filed, they can righteously claim not to have made any such statements.
Haggans adds, "The FDA has instituted 'good manufacturing practices' (GMP) that manufacturers must follow to ensure the identity and quality of supplements and they can take enforcement action if it's unsafe or unfit for human consumption, but they do not routinely test products." Once manufacturers implement these practices, they can display a seal on their packaging, noting their compliance. The problem with this is that the FDA has not issued regulations outlining the GMPs. People think that because congress authorized this, that it must be so.
To be clear about this, the Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized but did not require the FDA to adopt new federal regulations for GMPs for dietary supplements. Under DSHEA, the FDA can issue GMP regulations for dietary supplements that are modeled after food GMPs. To this day, the FDA has not issued any regulations about GMPs.
Like drugs, supplements can combine with other medications in unhealthy ways. "Dietary supplements can interact with both over-the-counter and prescription medication," Haggans says. "That's one reason we tell people to talk with their doctors about all the supplements that they're taking." For example, the anticoagulant medicine warfarin (Coumadin) can interact with gingko biloba and with garlic and cause bleeding. St. John's wort, which is often used to treat depression, can weaken the effects of birth control pills and other medications. Vitamins C and E can also potentially interfere with chemotherapy used to treat cancer.
Doctors might not know about interactions between supplements and prescriptions and since supplement labels don't list warnings, patients need to do their own research: look for guidance from the sites listed in the resource section and talk to a nutritionist or check with reliable sources at "health food" stores or reputable "wellness" centers. This is a situation where watching carefully for side effects is especially important and consumers are mostly on their own to be vigilant.
Some supplements can be monitored by testing blood levels. This can be expensive but it might also reduce problems related to potential toxicity or unusual individual reactions. Check with your doctor to see if blood tests might be suitable for you.
Where can consumers get information? Check with the Office of Dietary Supplements, the National Center for Complementary and Alternative Medicine, and the Memorial Sloan-Kettering Cancer Center. Both keep regularly updated fact sheets on the most commonly used herbs, supplements and vitamins.
Read this article about the supplements.
June 1, 2011
Do Your Homework Before Taking Supplements - P1
Have you heard of GMP (good manufacturing practices)? Most people have not and for good reason. Congress authorized FDA to set up a plan, but did not make it mandatory. Several organizations that have members among the supplement manufactures set up and submitted some plans to the FDA, but nothing happened. The Federal Drug Administration has done nothing about this, except, yes there is always an exception, occasionally rattling the cage about investigating some supplement here and there.
If you are looking for a reliable manufacturing seal on supplements, forget about it. Those that do exist have no weight of enforcement behind them and are industry developed to say that they have seals of quality for the supplement. The level of quality varies greatly from manufacturer to manufacturer and does not guarantee absolute quality or even that what may be claimed on the product can be depended upon.
I have had health store employees tell me that their products are manufactured under the GMP and have a quality guarantee seal. When I ask who issued the seal, they look at me as if I must have misunderstood their statement and repeat it. When I ask to see the official government seal, they point out the manufacturers seal. I ask if it has been approved by the FDA. Their answer is often yes. Then I ask under which government authorization act was this authorized. Smiles come then and they say The Dietary Supplement Health and Education Act of 1994 (DSHEA). Thinking they had me, they want to know which supplements I wish to purchase.
I then say that I am aware of the act of 1994, but it only authorized FDA to set up regulations, but that the FDA had never set up any regulations. I then say I don't like smoke being blown up my - you know where - and promptly leave the store. One store even had the nerve to call me back to inquire which government agency I worked for. I refused to answer naturally, but did say a full report would be filed. This I did, but to my congressional representative in an email, which I am sure was routed to the delete file.
Over the years, I have only had one store that answered my questions correctly and admitted there was no way to be sure of the quality in every batch from the manufacturer, but that if I felt that something was wrong with any purchase I made they would refund any money upon presentation of the store receipt. I was tempted, but could not bring myself to pay the price asked as it was almost double what I would have paid from any grocery store or warehouse type store.
Do I use any supplements? Yes, I do after I have check out the manufacturer and found few, if any complaints via their local better business bureau and several other agencies. I also look at their internet site for possible claims they make about their products.
There are many conflicting sites of information about supplements and I may not have the best ones, but I looked at approximately 20 sites and chose these. Site 1, Site 2, Site 3, and Site 4. Even though several of the sites show seals to be applied to products, none of them have any government enforcement authority to assure quality.
If you are looking for a reliable manufacturing seal on supplements, forget about it. Those that do exist have no weight of enforcement behind them and are industry developed to say that they have seals of quality for the supplement. The level of quality varies greatly from manufacturer to manufacturer and does not guarantee absolute quality or even that what may be claimed on the product can be depended upon.
I have had health store employees tell me that their products are manufactured under the GMP and have a quality guarantee seal. When I ask who issued the seal, they look at me as if I must have misunderstood their statement and repeat it. When I ask to see the official government seal, they point out the manufacturers seal. I ask if it has been approved by the FDA. Their answer is often yes. Then I ask under which government authorization act was this authorized. Smiles come then and they say The Dietary Supplement Health and Education Act of 1994 (DSHEA). Thinking they had me, they want to know which supplements I wish to purchase.
I then say that I am aware of the act of 1994, but it only authorized FDA to set up regulations, but that the FDA had never set up any regulations. I then say I don't like smoke being blown up my - you know where - and promptly leave the store. One store even had the nerve to call me back to inquire which government agency I worked for. I refused to answer naturally, but did say a full report would be filed. This I did, but to my congressional representative in an email, which I am sure was routed to the delete file.
Over the years, I have only had one store that answered my questions correctly and admitted there was no way to be sure of the quality in every batch from the manufacturer, but that if I felt that something was wrong with any purchase I made they would refund any money upon presentation of the store receipt. I was tempted, but could not bring myself to pay the price asked as it was almost double what I would have paid from any grocery store or warehouse type store.
Do I use any supplements? Yes, I do after I have check out the manufacturer and found few, if any complaints via their local better business bureau and several other agencies. I also look at their internet site for possible claims they make about their products.
There are many conflicting sites of information about supplements and I may not have the best ones, but I looked at approximately 20 sites and chose these. Site 1, Site 2, Site 3, and Site 4. Even though several of the sites show seals to be applied to products, none of them have any government enforcement authority to assure quality.
May 30, 2011
Do You Think the Medication Label is Excessive?
There are many doctors saying that the medication's label leads to information overload. Then why do these doctors want to prescribe medications with many side-effects that may harm their patients? Because, this is what they do and many do not even read about the medications they prescribe. They listen to what the Big Pharma salesperson says and start prescribing.
Then they have patients that start having some of the side-effects listed on the label and know they have problems and just want to believe it is in the patient's head. That is the main reason they want less side-effects listed so they have an easier time convincing their patients that it is all in their heads. This is just my take and the article has not changed my mind.
Yes, the doctors are saying that this information overload is having a negative effect on some people who could benefit from certain prescription medications. The doctors seem rather insistent in their request and want Big Pharma to reduce the number of side-effects listed.
Jon Duke, MD, an assistant professor of medicine at Indiana University School of Medicine in Indianapolis and a researcher at the Regenstrief Institute says he and his colleagues are developing software to help filter, prioritize, and personalize relevant drug safety information. He says he envisions “a dynamic label that uses electronic medical records to pull in the information that is most relevant.”
Unless and until such changes are made, “the key thing is to ask your doctor about side effects because doctors are pretty good filters,” Duke says. “There are some things that most people will never, ever get yet patients are often afraid to take the medicines because of how scary the labels are."
The big question is how well the doctors know the side effects, how they are able to determine which ones are the ones that need concern, and how well do they know their patients. Many doctors fail to take into account the individual patient and how they may be affected by the different side-effects. Certain patients have a greater tendency to be sensitive for certain side-effects while other patients can tolerate the same side-effects. So how does the doctor know?
While this whole thing is directed at the FDA, the side effects may be more that the patients desire if the problems from side effects are not reported until after the patient has problems and ends up in the emergency room or worst yet the morgue. I would rather know about the side effects than having them get the best of me.
Read the article here.
Then they have patients that start having some of the side-effects listed on the label and know they have problems and just want to believe it is in the patient's head. That is the main reason they want less side-effects listed so they have an easier time convincing their patients that it is all in their heads. This is just my take and the article has not changed my mind.
Yes, the doctors are saying that this information overload is having a negative effect on some people who could benefit from certain prescription medications. The doctors seem rather insistent in their request and want Big Pharma to reduce the number of side-effects listed.
Jon Duke, MD, an assistant professor of medicine at Indiana University School of Medicine in Indianapolis and a researcher at the Regenstrief Institute says he and his colleagues are developing software to help filter, prioritize, and personalize relevant drug safety information. He says he envisions “a dynamic label that uses electronic medical records to pull in the information that is most relevant.”
Unless and until such changes are made, “the key thing is to ask your doctor about side effects because doctors are pretty good filters,” Duke says. “There are some things that most people will never, ever get yet patients are often afraid to take the medicines because of how scary the labels are."
The big question is how well the doctors know the side effects, how they are able to determine which ones are the ones that need concern, and how well do they know their patients. Many doctors fail to take into account the individual patient and how they may be affected by the different side-effects. Certain patients have a greater tendency to be sensitive for certain side-effects while other patients can tolerate the same side-effects. So how does the doctor know?
While this whole thing is directed at the FDA, the side effects may be more that the patients desire if the problems from side effects are not reported until after the patient has problems and ends up in the emergency room or worst yet the morgue. I would rather know about the side effects than having them get the best of me.
Read the article here.
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