Problems When Patients Hide Supplements – Part 2

Part 2 of 7 parts.

The United States has seen the use of dietary supplements steadily increase from less than 20 percent of the population in 1970 to approximately 50 percent at the time of the last survey in 2006. Individuals report using dietary supplements to increase energy, maintain strength, enhance performance, maintain health and immune system function, and prevent nutritional deficiencies. Only 33.4 percent of individuals, however, inform their doctors that they are taking herbal products and dietary supplements.

Most consumers aren't aware that the health claims on labels intended for marketing purposes may not be accurate. Although dietary supplements are regulated by the US Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and drugs.

Individuals who use dietary supplements believe that these products help them retain control of their own health. Patients typically believe that dietary supplements are not drugs and for that reason have fewer side effects than conventional medications.

Whether a product is classified as a dietary supplement, conventional food, or drug depends on its intended use. Classification as a dietary supplement is usually determined by the information provided by the manufacturer on the product label or in accompanying literature, although many food and dietary supplement product labels lack these details.

The term "dietary supplement" is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) as a product, intended to supplement the diet, that bears or contains one or more of the following dietary ingredients:

• Vitamin;
• Mineral;
• Herb or other botanical;
• Amino acid;
• Dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
• Concentrate, metabolite, constituent, extract, or combination of any ingredient described above.

A dietary supplement is intended for consuming as a tablet, capsule, powder, soft gel, gel cap, or liquid form. These products are not represented for use as conventional foods or as the sole item in a meal or diet and are labeled as "dietary supplements." Moreover, a dietary supplement may not contain a form or substance that is an approved drug or is authorized for investigation as a new drug, and for which substantial clinical investigations have been initiated and made public, unless that article was marketed as a food or a dietary supplement prior to its approval as a new drug or authorization as an investigational new drug. Vitamin D is an example of a dietary supplement that may soon begin to be marketed as a drug.

The FDA regulates dietary supplements under a different set of rules than those covering conventional foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market. Generally, manufacturers do not need to register their products with the FDA or get FDA approval before producing or selling dietary supplements. However, manufacturers must make certain that product label information is truthful and not misleading.

The FDA's post-marketing responsibilities include monitoring safety (eg, voluntary dietary supplement adverse event reporting) and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates advertising for dietary supplements. Domestic and foreign facilities that also manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register their facilities with the FDA.

Did You Participate in the FDA Conference?

I had wanted to, but a doctor appointment was more important. I was on the road minutes after the start of the conference and did not return home until an hour after it was supposed to end.

The appointment was not what I had hoped for on A1c, but the rest was all in the ranges for each test. Finally, a doctor that felt my A1c should be lower and was not asking me to let it rise. At least this time I know I will need to work more diligently to bring it down – means no more snacks.

At least one website now has something posted about the conference and how the FDA could not handle the numbers of people participating and the site crashed. Rather than regurgitate what has already be stated, please read the blog at Diabetes Mine.

Thank you.

AACE Urges Congress to Act

When I first read about this a couple of weeks ago, I was not happy with the American Association of Clinical Endocrinologists. My first thoughts were that the AACE would undo some of the good that the group Strip Safety had accomplished. But the more I thought about it, I soon realized that Alan J. Garber, M.D. of nefarious fame of the AACE was not calling the shots. I also realized that the more help for diabetes and the tools for diabetes, the better off we all could be.

The letter, signed by AACE president Mack Harrell, MD, and president-elect George Grunberger, MD, called for the passage of two bills: the Medicare CGM Access Act (HR5644/S2689), and the National Diabetes Clinical Care Commission Act (HR1074/S539). The latter would establish a public/private commission to coordinate activities that currently span 35 federal departments, agencies, and offices, according to the statement.

The letter also asks Congress to conduct follow-up hearings to examine FDA's pre- and postmarketing surveillance and enforcement activities for medical devices, along with a call for a review of Medicare's competitive bidding practices. With regard to the FDA, the AACE is asking for more rigorous pre- and postmarket surveillance of glucose testing supplies and the prohibition of devices that don't meet current quality standards.

The above are all needed and if accomplished, could be a big help for all people with diabetes. The Medicare CGM Access Act promotes Medicare coverage of continuous glucose monitors. Currently, Medicare does not reimburse for CGM, which means that well-controlled patients with type 1 diabetes lose an important means of monitoring once they hit the eligibility age of 65. Grunburger said it is unclear why Medicare does not cover the devices, despite the evidence of benefit and cost savings. The device has been associated with a reduction in hospitalizations for hypoglycemia.

Are People with Diabetes Taking Too Many Supplements?

This is one of the better blogs by a CDE and deserves readership by people with diabetes even though it is written for CDEs on the AADE website. Carla Cox is right that there has been resurgence in advertising for herbal and other supplements. Late night TV has many advertisements for drugs that are supposed to help people with diabetes get off diabetes medications and others to help with weight loss.

The National Center for Complementary and Alternative Medicine says that nearly 40 percent of Americans use health care methods that are not considered mainstream medicine. The website for the National Center for Complementary and Alternative Medicine is here. Over half of the people with diabetes reportedly take nutritional supplements. Of these people, persons with type 2 are twice as likely and those with type 1 to use nutritional supplements.

In reading on diabetes forums, I often see alpha lipoic acid, cinnamon, chromium, ginkgo biloba, and a few others mentioned for various other maladies. The biggest problem for Complementary and Alternative Medicine (CAM) Supplement use that Ms. Cox is concerned about is the lack of double-blinded randomized control trails for most of the supplements.

One source is American Diabetes Association Guide to Herbs and Nutritional Supplements: What You Need to Know from Aloe to Zinc. This book is available through most bookstores and many libraries.

I do appreciate that Ms. Cox made the following statement. “It’s important to recognize that all products that change the way our body works are drugs, whether they come from “natural” or synthetic sources.” It is a problem that herbal products and supplements lack production and marketing oversight and then must be proven to cause serious health problems before they can be removed from the market.

Ms. Cox concluded her blog with a statement to ask the patients which supplements they are taking and why. Then she instructs CDEs to assess whether the supplements are healthful, harmful, or just costing patients extra money they may ill afford.

This was not available when the blog was written, but the FDA has declared one problem people with diabetes have, inflammation, a disease. This will open the door for Big Pharma to manufacture drugs for inflammation and prevent CAM from dominating in this area. I know that Big Pharma is pushing the FDA to do this in more areas as well.

Glucose Test Strip Accuracy Not Resolved

Will the Food and Drug Administration (FDA) actually do anything to insure quality in our test strips once they have approved them? Some people are hoping the FDA will take a stronger position and do more checking, but I certainly would not want to rely on this. I seriously would not even think they will do anything to enforce this. In the discussions to date, all they seem concerned about is the manufacturing plants and worry about how they will discover anything wrong with the test strips. This they claim because they announce that they are inspecting and the companies will be ready for them.


What I do not understand is why they must inspect the manufacturing facilities. Why isn't the FDA capable of walking into a pharmacy and purchasing a few vials of test strips and testing these? Oh, I had forgotten, this would cost money and the test strip companies are not putting up money paid to the FDA for continued certification. Therefore, the FDA will not likely do any further testing. Yes, the FDA will posture and say many things, but I seriously doubt any action will be taken.


It is easy for a FDA spokesperson to say, "Glucose meters have always been a priority for the FDA. This is an area that's complex, where lots of things happen… It's always been high on our list." Yes, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health at the FDA did say this, but what does it mean? It just means that in the future, the FDA will seek assurances that the manufacturers will monitor quality control. With the attention drawn to strip safety, this is the preferred method of action. Notice how often this phrase “going forward” is used by all people speaking for the FDA. This is used to indicate everything is applicable... going forward, but means nothing in the present and is not a promise to do anything.


Katharine Serrano, diabetes branch chief, division of chemistry and toxicology devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH) at the FDA, is quick to dismiss studies by Roche Diagnostics. Her statement, “However, any decision by the FDA to pursue regulatory action or change policy in this area would typically be based on a review of multiple sources of information on the post market performance of these systems," means that they are brushing off the Roche studies. Bold is my emphasis.

Plot Between FDA and Big Pharma Thickens - P2

This press article is somewhat anticlimactic after the previous blog. It is still about Pfizer and the anti-smoking drug Chantix but dated on June 12, 2008. There are some things in the article that I have to question about why ABC News dot com did not check their facts since they had published a story about Chantix.

Quote Now a new report from the nonprofit organization Institute for Safe Medicine Practices cites nearly 1,000 adverse event reports associated with Chantix. That report, released late last month, has prompted the Federal Aviation Administration to ban the drug's use among commercial pilots. Unquote

Now from the June 17, 2008 article – Quote The FAA has prohibited commercial airline pilots from using Chantix because of its possible side effects. Unquote  Yes, the difference of two words “ban” and “prohibit”, but in the world of commercial safety, there is little distinction between the two words. Both indicate that the pilot would be grounded and possibly lose a commercial aviation license for using Chantix.

The biggest plus for the article is that finally shows FDA is doing what it should have back in 2008 when it only warned the Veterans Administration of problems. One does have to wonder how they swept that story under the rug. It does not speak well for the FDA and their review procedures when they can issue a warning to another government agency (that chose to ignore it) and then to ignore the public in the face of mounting evidence. Reminiscent of Avandia anyone?

So this does indeed raise an issue of how much collusion is happening between the FDA and Big Pharma. Are certain interests within the FDA not alerting the public and taking actions at the behest of Big Pharma? With some hesitation, I would have to agree that some evidence certainly indicates that to be happening. I had thought maybe Jo was pushing a little in her blog, but after reading the two articles, I would have to agree with her.

I certainly am more concerned about the safety of many drugs and the side-effects that are not made public until after the elephant has done the damage.

For those that need to read Jo's blog, it is here. For those that did not read the June 17, 2008 article about the abuse of our veterans, it is here and the June 12, 2008 article can be found here.  NOTE:  Jo's blog no longer exists - 10/28/13

Plot Between FDA and Big Pharma Thickens - P1

Normally, I leave topics like this for others, but my dander is up and I feel our government is again abusing our veterans and the Federal Food and Drug Administration plus the Veterans Administration is in bed with Big Pharma. This is a combination that I can't in good conscience look the other way on. My thanks go out to another blogger Jo who blogs at joscafe dot com for blogging about this and providing the links. And I don't care that this is not about diabetes.

Since I am also a veteran, I am compelled to write this and am still pulling my thoughts together. I am not even sure how many parts - I am putting this in two parts. First, I will concentrate on the abuse of our veterans and the shame of our government in cooperation with Big Pharma (Pfizer is just one of many and the maker of the drug being exposed) is doing to our veterans. It is a disgrace that our history is such a minefield for our veterans since the end of WWII and probably goes back further than that. Many veterans have been part of cruel medical experiments since then, and the Iraq and Afghanistan conflicts is proving no exception.

Why our Veterans Administration insists on being part of this disgrace is beyond comprehension. Many of our veterans end up in mental institutions because of the experiments they are subjected to and I have to wonder it this is not a part of the increased suicide rate among returning veterans. Even though the article is from June 17, 2008, this and much similar studies are still taking place today.

The ABC News dot go dot com story is properly titled “ 'Disposable Heroes': Veterans Used To Test Suicide-Linked Drugs”. Mentally distressed veterans are being recruited for government tests on pharmaceutical drugs linked to suicide and other violent side effects. One of the human experiments involves the anti-smoking drug Chantix.

Veterans Administration doctors were warned on November 20, 2007, January 18, 2008 and February 1, 2008, by the FDA and Pfizer, but did not issue a warning to the veterans until February 29, 2008.

The following is quoted from the press article to show how little respect the Veterans Administration has for the lives of our veterans. Quote "How this study continued in the face of these difficulties is almost impossible to understand," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

Doctors at the Veterans Administration say they acted as quickly as they could.

"This didn't justify an emergency warning at that level," said Dr. Miles McFall, co-administrator of the VA study.

Dr. McFall said there is no proof that Elliott's breakdown was caused by Chantix and he sees no reason to discontinue the study(1). Some 140 veterans diagnosed with Post Traumatic Stress Disorder continue to receive Chantix as part of a smoking cessation study.

Dr. McFall says the VA decided to continue the Chantix study because "it would be depriving our veterans of an effective method of treatment to help them stop smoking."

Caplan, one of the country's leading medical ethicists, said he was stunned by the VA's decision to continue the Chantix experiment.

"Why take the group most a risk and keep them going? That doesn't make any sense, once you know the risk is there," he said.

Chantix is one of the drugs being used in an estimated 25 clinical studies using veterans by the VA.

Pfizer maintains that "the benefits of Chantix outweigh the risks" and that it continues to do further studies on the drug.

The FAA has prohibited commercial airline pilots from using Chantix because of its possible side effects. Unquote

This is my opinion, but doctors like McFall are the mad people in today's military and need to be convicted for their crimes against our veterans. Please read the full news article for the full impact.
 
(1)  This is standard military denial.  If you say if often enough and to enough people you can see them actually believing this.  (Agent Orange from Viet Nam Conflict anyone?)

Do Your Homework Before Taking Supplements - P2

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.