Many Recalled Dietary Supplements Remain Unchanged

From recent studies, it appears that many dietary supplement manufacturers that have recalls made because of contaminated products, thumb their nose at the FDA and continue to sell the product. How bad is it? A study published in the October 22/29 issue of JAMA found that about two-thirds of FDA recalled dietary supplements analyzed, still contained banned drugs 6 months after being recalled. It is sad that this study has to be behind a pay wall.

The U.S. Food and Drug Administration (FDA) initiates class I drug recalls when products have the possibility of causing serious adverse health consequences or death. The FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. Research has found that even after FDA recalls, dietary supplements remain available on store shelves. However, it has not been known if the supplements on sale after FDA recalls are free of the adulterants, according to background information in the article.

Pieter A. Cohen, M.D., of Harvard Medical School, Boston, and colleagues conducted a study to determine if banned drugs were still present in dietary supplements purchased at least six months after a recall. Twenty-seven of the 274 FDA recalled supplements (9.9 percent) met inclusion criteria for the study. These supplements were analyzed using the same methods at the FDA’s laboratories (e.g., gas chromatography/mass spectrometry). Supplements were purchased an average of 34.3 months (range 8-52 months) after the FDA recall. Seventy-four percent of supplements (20 of the 27) were produced by U.S. manufacturers.

The researchers found that one or more pharmaceutical adulterant was identified in 66.7 percent of recalled supplements still available for purchase (18 of the 27). Supplements remained adulterated in 85 percent (11 of 13) of those for sports enhancement, 67 percent (6 of 9) for weight loss, and 20 percent (1 of 5) for sexual enhancement. Of the subset of supplements produced by U.S. manufacturers, 65 percent (13 of the 20) remained adulterated with banned ingredients.

Sixty-three percent of analyzed supplements contained the same adulterant identified by the FDA. Six (22.2 percent) supplements contained 1 or more additional banned ingredients not identified by the FDA. Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.

“To our knowledge, this is the first study to determine if adulterants remain in supplements sold after FDA recalls,” the authors write. “Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace. More aggressive enforcement of the law, changes to the law to increase the FDA's enforcement powers, or both will be required if sales of these products are to be prevented in the future.”

Are You Staying within Your Calorie Budget?

I know some people with type 2 diabetes are, but many are not because they are totally immersed in counting carbohydrates and they ignore calories. How many calories have you eaten today, how many should you eat? Many can guess how many calories do you need? The 2000-calorie-a-day standard is just a ballpark figure, used by FDA to calculate daily values on food labels. The following table will give you more of a range. The weakness of the table is no information is listed for active adults and for children and adolescents.

Here are the typical calorie needs of inactive adults, according to the U.S. Department of Agriculture:

WOMEN

• Ages 19-30: 2,000 calories

• Ages 31-50: 1,800 calories

• Ages 51-plus: 1,600 calories

MEN

• Ages 19-30: 2,400 calories
• Ages 31-50: 2,200 calories
• Ages 51-plus: 2,000 calories

These age ranges are for people in good health and not for people with chronic diseases like type 2 diabetes. In addition, I would question the age ranges above 51, as there could be other ranges that need clarification for people over 70. Since I am not an expert in counting calories, my guess would be that for people with type 2 diabetes should probably be less that the calories above.

Again, get out the blood glucose meter and use this before and after consuming a meal. This will also tell you if you are eating too many calories. People that are very active can probably consume more calories. There are calorie calculators like this at the Mayo Clinic website. Just be aware that all calorie calculators are based on a one-size-fits-all basis.

Just like carb counting, there are variables to consider. Metabolism is a big variable – do you have an unusually slow or fast burning metabolism. Fortunately, a doctor can give you a breath test to check that. This knowledge will help the doctor and you set an individualized calorie goal.

A majority of adults need or want to lose weight. For this, there is a one-size-fits-all calorie formula. This will work for some people, but many will not have success. If you change your level of exercise, you may lose more weight and faster than anticipated.

For people with type 2 diabetes, stick with the carbohydrate count and start learning the calorie count. This is because some foods are higher in calories than the carbohydrate count and a few foods are higher in carbohydrate count than calorie count.

We Need Self-Monitoring of Blood Glucose Taught

Many government agencies don't want this to happen. Chief among them is the US Dept of Agriculture (USDA) and the National Institute of Health (NIH). Other federal agencies also follow suit. This means that the Academy of Nutrition and Dietetics (AND), Certified Diabetes Educators, the American Diabetes Association (ADA), and the American Association of Clinical Endocrinologists (AACE) follow in lock step.

Naturally, the medical insurance industry follow the recommendations of the ADA and AACE. This means that we as patients have to work harder to obtain the test strips to know what our blood glucose levels are for us to manage our diabetes more effectively. Not knowing and operating in the dark is not the way effectively to manage diabetes.

Most blogs by CDEs and RDs never mention using our blood glucose meters with test strips because they don't want us to know how the different foods affect our blood glucose levels. This is part of the reason many people get discouraged and seldom test their blood glucose levels. This almost guarantees that diabetes will become progressive and that the complications will affect the quality of life. Self-Monitoring of Blood Glucose (SMBG) is shunned by CDEs and not talked about by RDs.

If it wasn't the leadership of the USDA and the blind following by AND, we might have reason to listen to a few that do teach SMBG. A few CDEs that do not have to worry about other CDEs looking over their shoulders, do teach Diabetes Self-Management Education (DSME) of which SMBG is a part. Many will not even teach DSME because they only believe in mandates and dogma and expect people blindly to follow. With the internet of today, this will only get worse as people learn what following these people will do to damage their health.

At least some people from the Duke University of Nursing at Durham, NC are doing something about what the CDEs are unwilling to accomplish. Read about this in a recent blog here. They are at least reviewing various methods of delivering diabetes self-management education (DSME) via the internet.

Then people with type 2 diabetes and those with prediabetes will have resources to learn about managing their diabetes. Then if the certified diabetes educators want to be exclusive and continue to make it more difficult to become a CDE and for their numbers to grow, we can ignore them and learn on the internet.

The unfortunate part of this is that it is just a study and there is no sources of DSME as such on the internet for easy access. This in one time I sincerely wish that people would put information on the Internet and then do a study instead of studying other studies. Yes, I was honestly thinking that there was a source of DSME on the Internet and that it could be available to all people with type 2 diabetes. While the study details were interesting, that is as far as it was taken.

Have Diabetes, Stop Worrying About Eggs

I know some people with or without diabetes that cannot stomach eggs. For the rest of you, eggs are a great source of protein and cholesterol will not be a problem – much to your disbelief.

According to Nicholas Fuller, PhD, from the Boden Institute Clinical Trials Unit, University of Sydney, Australia, the findings of a study suggest that eating two eggs per day, 6 days a week can be a safe part of a healthy diet for people with type 2 diabetes. The study lasted for 3 months, a time-span in which a change in cholesterol levels can become clear. It was supported by a research grant from the Australian Egg Corporation.

Yes, I know, this suggests a study that may not be without bias. A study for three months can also hide some trends and give results desired. At least Fuller said there is a lack of research into the effects of eating high amounts of eggs in people with type 2 diabetes. National guidelines on eating eggs and total cholesterol limits are inconclusive, though, and guidelines vary between different countries.

Researchers also found that eating an egg-rich diet for 3 months was linked to better appetite control, and may provide a greater sense of satiety (feeling full). Fuller said the study was motivated by the negative perception widely held toward eggs in the diets of people with type 2 diabetes.

I was a little surprised when I looked into the study and discovered that it was also a weight-control study. The study participants were required to report to the clinic each month. During the visit, they were given advice that had to follow about the types of foods and amount they could eat. Saturated fats were not allowed, but certain unsaturated fats were.

The number of participants was 140 overweight people with type 2 diabetes and they were divided into two groups – one group that would eat less than two eggs per week and the second group that would eat two eggs per day at breakfast for six days per week. Too small a study to begin with, but the results is now questionable, even the low-egg group consuming matching protein with the high-egg group. As expected, both groups were tested for cholesterol levels.

The other expected statement was the lead author calling for more research to confirm whether a high-egg diet in people with type 2 diabetes does raise HDL (good) cholesterol. Fuller commented that despite both groups being equalized for protein consumed, the high-egg group reported less hunger and greater fullness after meals.

Eggs may also help with greater weight loss, less weight regain than a conventional diet, due to the greater fullness, and less hunger reported with a high-egg diet. The high-egg group also reported more enjoyment of foods, less boredom, and more satisfaction with the diet.

I can speak to the latter quite easily now that I can eat eggs again after having my gallbladder removed. Prior to that, every time I ate hard-boiled eggs or egg salad, I would have a severe gallbladder attack. I like my eggs cooked in a wide variety of ways and can eat four to seven per day without thinking about it. I like scrambled, poached, hard & soft-boiled, fried, egg salad, and several other methods. Since my cholesterol levels are remaining where they should, I will continue to enjoy my eggs.

Type 2 Best Diet Plans – Oh Really?

First, diets fail and are considered for the short term. People with type 2 diabetes do not need something for the short term, but the long term – for the rest of our lives. As with any article written by doctors or professional writers, they forget about one crucial fact. People with type 2 diabetes should use their blood glucose meter with test strips to determine how the food affects their blood glucose levels.

Now I may be wrong, but I generally ignore writers that don't mention the above and write as if they have all the answers for food that people with type 2 diabetes should be eating. I did take time to talk with my cousin and she looked up the WebMD article and read it. She commented that they were some powerful diets and most were not suited to good weight loss. She said if they were careful about the number of calories consumed they could lose weight, but otherwise with many of the diets, they would maintain weight and maybe lose a few pounds before they gave up the diet.

She continued that many are not into lifestyle changes and thus a diet is the way possibly for short-term weight loss, but not keeping the weight off. I agree with this and said this was my thinking as well. Both of us were upset by the slides referred to in the article. We agreed that everything had to be high carb, low fat and that the recommended number of carbohydrates in slide 2 of 21, of 45-75 grams for every meal is totally unreasonable for everyone. With this recommendation, most people will gain weight, and we have to wonder whom the experts were to make this statement.

While we both agree that, “No food is off-limits with diabetes,” and without using our meters with test strips, we will never understand or be able to manage diabetes. Our meters tell us if the number of carbohydrates we consumed is too large. Then we have to decide whether to reduce the number of carbohydrates or eliminate that food from our food plan.

The DASH Diet, The Mediterranean Diet, Mark Bittman's VB6 Diet, The Volumetrics Diet, The Biggest Loser Diet, American Diabetes Association Carbohydrate Counting, Ornish Diet/The Spectrum, Weight Watchers are the diets listed in the WebMD article.  I will let you read the article, but none of these diets will work for the long term.

While many people praise these diets, I will not, primarily because they contain too many carbohydrates, too little fat, and too little protein. I also am concerned about the amount of whole grains many of the diets promote. If you use your meter, and if you are meeting your blood glucose goals, then okay. If your blood glucose levels spike above 140 mg/dl, then by all means consider reducing the serving size or eliminating the food from your food plan.

Does Your Doctor Refill Prescriptions by Phone?

This blog was a little surprising after my two blogs on prescription errors, but we can always learn more. Yes, most doctors will not issue prescription over the phone and here are some instances when a doctor will not refill the requested medicine:

• One of his/her partner’s patients calls after hours for a refill on narcotics - they can become adictive.
• A patient wants a refill beyond his/her expertise. He/she won’t be refilling your cardiac medicines as this should be done by the prescribing physician for several self-evident reasons.
• He/she hasn't seen the patient recently.

Most doctors hesitate for valid reasons for wanting to see a patient before issuing a prescription(s). The author lists these six reasons:

1. Does this specific drug still make sense?
2. Can the dosage be lowered?
3. Have any new symptoms developed that might require diagnostic investigation? Suppose the patient has been losing weight, for example? What if the heartburn has worsened and a new disease is responsible?
4. Is the patient experiencing side effects from the medicine that he or his primary care physician might not appreciate?
5. Could the heartburn medicine interfere with new drugs that the patient is now taking?
6. Is the patient up to date on other issues within a gastroenterologist’s responsibility such as colon cancer screening?

Refilling routine medicines may not be routine and should be done with care and caution. The author uses this example - a patient from 2 years back who has GERD might think he needs Nexium for his heartburn. What if his symptom is actually angina? Get my point?

The author says, when we ask you to stop in for a brief visit, it’s not because we delight in hassling you or are hungry for your co-pay. We’re trying to protect you and to keep you well. Doesn’t this seem like the right prescription?

Some prescriptions can be written without seeing the patient if the patients keeps regular appointments. I have had this happen quite often. This is because I have been seeing the doctor almost quarterly for over 14 years and have always been up front with him. I needed some heavy duty pain killers, and for that he wanted to see me which I had no problems with this because my research had told me this would be necessary as the medication would be a narcotic and they don't like prescribing those. After doing an examination and another doctor had done a few tests, I was able to get my prescription and several refills.

When I asked that the strength be reduced about two months later, he did, but told me I would need to see him before any more refills. Since I would have an appointment two weeks later, I reminded him of that and he said he would prescribe enough to get me to that appointment. By my appointment, I was out and told the doctor I did not need any more as the pain had subsided a few days before. I am happy that I have not had any further pain and even the doctor is happy that I don't need the medicine.

October Meeting with Our New Members

We knew that our meeting was going to be different, but how different we did not know until our meeting started. Even Tim was caught off guard. Sue and her husband were absent because Sue's mother had passed. However, the number of new members more than made up the difference. We had expected six new members, but were in shock when 14 people showed up.

Jerry said that four were others that he had unable to contract for our prior meeting with the nutritionist, and four of the six had brought another person with type 2 diabetes. After introductions, Tim asked each of the potential new members to think of a nickname to use. Tim then explained that we use the nicknames to keep tabs on each other and allow them to talk to other members without letting others around them know whom they are talking about.

Then Tim opened it up for questions from the new members. Most wanted to know how often we meet. Barry told them that this varies. We try to meet once a month, but this can be upset by other events. Barry continued that we normally do not have meetings in June, July, and August. However, this year, we had two meetings in August, but not for everyone. We had two meetings in September and now two meetings in October. In addition to our November meeting, several will be making a presentation to another group.

Jerry spoke up then and said two of the meetings were for him and those seeing his dietitian wife. He continued that they take things as they happen and try to make the most out of events. He said if they need three meetings to accomplish something, they will have three meetings. Tim said that is right. Sometimes it is only five or more people that can have a special meeting, but we have one meeting per month for everyone. Brenda said this happens because we are not secretive about our diabetes and different numbers of us can be working on different projects.

Allen said that this happened this year as we had three meetings on interventions to help us know how to help other people with type 2 diabetes. James said that he was the subject on one intervention, but not by this group, but during a meeting of several groups. Tim said Jerry was an intervention project of several of the members and those that Jerry was able to contact were brought to a meeting not requiring an intervention.

The next question was about membership and would we be limiting membership. Jason spoke and said this is something I think all of us have thought about. At one time, we were at almost 20 members, but because we like our somewhat informal nature, a few split off from our group. Greg is the leader of that group now. They wanted formal officers, meetings on a specific day each month, and other set rules.

Tim said that he was elected as group leader, Barry was program chairperson, and A.J is group historian. We don't have a treasurer because we don't collect dues and or other officers because we don't need them. Two of us send out meeting summaries after each meeting, with one waiting until the other has sent out an email and then that person adds other points if necessary. Bob generally blogs about our meetings so we have several reminders of what transpired. This way if someone needs to miss a meeting, they don't feel like they were left out.

Tim stopped then, and said for all those new people present, to be sure he had their email address and telephone number given to him. Email addresses for meeting notices and summaries. The phone numbers in case they were needed for something special. He stated that all those new to the group would be sent the email addresses and phone numbers for the rest of the members.

The meeting continued for another hour with more questions from the new members and some from our group. Max said we have a question that needs a vote or thought until the next meeting. Tim said yes, do we want to limit members or add more members. The group agreed that for the present, we would not limit membership, but would take up the question again when we were near 45 members. Everyone present did want to become members. The vote was unanimous and we went from 17 to 31 members that quickly.

A couple of the new members asked if they could attend the meeting when we presented the program. Tim asked if they knew the place and the one answered that he had grown up there. Tim said he would ask and let them know if they had room for visitors. This brought several more requests and Tim took the count (9 wanted to go) and said he wanted emails to be able to contact everyone. This ended the meeting and Tim collected email addresses and phone numbers.