Many NIH-Funded Clinical Trials Go Unpublished

At first reading, my reaction was maybe the studies arrived at conclusions not looked for and maybe were not news or worthy of publication. With many studies that do make the press and even some that do make the journals being highly suspect, we do need to be aware that many more studies never see print because of poor results. Are our researchers so agenda driven that when a study does not obtain the desired results, they bury the results.

These are just a few of the questions that need to be asked. These studies were funded by taxpayer dollars and therefore should be published. Even if they are not news or worthy of publication, there are alternative methods for providing timely public access to study results, including the results database at Clinical Trials.gov that was created in response to Federal law.

The study, which appears in the January issue of the British Medical Journal, states that less than one-half of the trials funded fully or in part by the National Institutes of Health were published within 30 months of completion and that one-third of trials remained unpublished 51 months after completion. This is a very poor return on investment and if the results were actually unworthy of publication indicates that approval needs to be reviewed to prevent poorly premised studies from being funded.

Science Daily again published their second report on January 5 on the same study and this report is more telling in the lack of reporting the their article of January 3. “They found that out of 738 trials that were classified as subject to mandatory reporting, just 163 (22 per cent) had reported results. The study found that the influence of the funding body or sponsor seemed to be considerable -- industry funded trials subject to mandatory reporting were far more likely to report results compared with other funders. Importantly a positive effect of the legislation was noted -- where trials did not fall under the legislation only 10 per cent of them had reported results.”

Another argument voiced in the press release says that when research findings are not disseminated, the scientific process is disrupted and allows redundant studies to be funded. Not only does this permit a waste of funds available for research of many pressing studies, but also it has far-reaching effects for policy decisions and even institutional review board assessments of risks and benefits associated with future research studies.

We all know that non-publication and delayed publication (and even burying of results) happens for studies and trials funded by the pharmaceutical and medical device industries, as well as by non-profit organizations. While the authors state more work needs to be done to understand the problems leading to publication, no mention is made of why poorly designed studies are allowed to be funded in the first place and the results buried when the researchers arrive at conclusions other than what they wanted. A procedure for determining who receives funding also needs a thorough review.

Then January 4, 2012 from the NIH makes this announcement “National Institute of General Medical Sciences reorganizes.” Make one wonder if they are taking this study seriously. This is highly doubtful as is clearly stated here, “The amount of money allocated to programs in the new divisions will not change as a result of the reorganization or transfer of NCRR programs. Most grants in the new divisions will continue to be managed by the same staff members.”

Will we see changes in publishing of studies? Highly doubtful! Just more layers of governmental bureaucracy.

Steps to Cut Medical Cost for Prediabetes Patients

Maybe someone has finally seen the light in diabetes prevention. This article in WebMD was published on June 28, 2011, but I had missed it until the other day. I hope this gets better recognition and acceptance, as there is a huge cost savings to be had if people with prediabetes can be educated and possibly accept taking Metformin to bring prediabetes under excellent management.

First, the medical insurance industry led by Medicare needs to recognize the potential in the future cost savings. This is because people with prediabetes can manage it quite effectively by a change in lifestyle habits plus exercise. If necessary, they may need to start on the diabetes drug Metformin to give their diabetes management time to be started and become effective. Then once they have made the necessary lifestyle changes and are continuing with an exercise regimen, it may be possible to cease taking Metformin.

Doing this may delay the full onset of type 2 diabetes or if a person becomes proficient in their management of prediabetes, they may be able to postpone the onset of type 2 diabetes for decades or possibly forever. Even some people with early diagnosis of type 2 diabetes are using exercise and diet to avoid medications entirely.

I think the study showed very conservative cost savings, but they are still savings. Those on Metformin alone save $1700 over a decade. Those doing extensive lifestyle changes like participating in tailored weight loss and exercise programs saved $2600 per person. The study also stated that the people who ate right and exercised had the highest scores on the quality-of-life survey that measures physical and mental well-being,

I do not know if this a misprint or not. “The cost-savings analysis comes from seven years of follow-up to the three-year study called he Diabetes Prevention Program (DPP). The study was halted early when both metformin and lifestyle changes far outperformed placebo. The DPP showed that 10 years of treatment with metformin lowered the risk of developing diabetes by 18%, while lifestyle changes reduced the chance by 34%.” This is somewhat confusing if the study was stopped yet they have 10 years of one treatment. Either way this should get more attention as prevention shows cost savings that should not be ignored.

Sleep Deprivation by Doctors Harms Patients

Sleep Deprivation is touted in the medical profession and doctors seem to think that it is okay. Not only that, but for doctors that report working too many hours are ostracized for reporting this. It is no wonder patients are so distrusting of doctors. We are slowly learning that doctors are not taking their Hippocratic Oath seriously and doing more patients harm than good.

These are some of the bad apples that need to be weeded out of the profession. It is small wonder that residents and doctors in training are fighting the system to reduce the work hours. I was harsh about the treatment of medical residents working hours, but this study points out that doctors are even harder on their fellow doctors when they do not work as many hours as their cohorts feel they should.

The lead investigator stated that they were surprised by the results of the study of before 2003 hours worked and the after 2003 hours worked. They suspected that the outcomes would have been the same before and after 2003. Instead, the complication rate decreased.

The following is an important statement, “In fact, many residents record their hours at below 80 and really work 80 hour weeks, and those that record otherwise or speak up are retaliated against by their superiors. Unfortunately, there is no real law to ensure the uniform standard being implemented by UCLA in accordance with the 2003 guidelines is actually being followed in other hospitals. The health care profession needs that type of enforceable law to make sure health care providers are not exceeding the maximum allowable hours and putting people's lives at risk.”

This ties in with another article by Trisha Torrey about the lack of hospital autopsies being performed. This is how many hospitals hide poor care and avoid families learning about mistakes doctors are making. Read this article as it points out many of the habits of hospitals to avoid troubles with family lawsuits.

Does Your Doctor Go On Autopilot?

This is a realization that I can relate to happening. I have one doctor that seems to go on autopilot during almost every visit. I will be analyzing key words in the future to see what sends him to autopilot. I do know that he is not in favor of patients that take a proactive role in their care and would prefer I just follow his instructions.

This is an excellent article about doctors and their discussion of using autopilot. I cannot blame the site for only allowing doctors to use the open discussion area. I can appreciate the topic being written about for the public area with some of the discussions included in the article.

Please take time to read the full article. This may help you understand your doctor when he switches to autopilot and teach you ways to recognize this, find ways to prevent autopilot, and help you turn his/her autopilot off. Time is important to us as patients and we will not get much information when a doctor goes on autopilot.

One doctor suggested that he uses handouts for information patients need. The doctor goes over the handouts pointing out the areas of good progress and areas needing attention with the patient before just handing it to the patient. The doctor says this may be autopilot, but at the same time gives the patient something to review. To me this would be acceptable especially if this allows time for answering your questions.

This can be a two-way disadvantage as one physician stated. If the patient recognizes the autopilot, they in turn will tune you out. Well stated doctor! For those patients that are proactive in their care, many will seek other doctors if autopilot is used regularly on them.

There are good reasons for using autopilot by some doctors, and for some cases, it can serve several purposes. It can get doctors past some sticky topics that need saying and the patients need to hear. It can prevent doctors from getting into areas that he/she knows the patient does not want to think about and would turn them off.

When you really think about doctors using autopilot, there can be good reasons, bad reasons and other reasons that need to be visualized. People all react differently and doctors need to realize this before switching to autopilot. Even the doctor thinking about how the patient will react may prevent switching to autopilot.

Honey Does Have Medicinal Properties

Honey is a favorite topic for me. I started keeping bees as a youngster and did for several years until college took me away. I have on occasion assisted other beekeepers in the years since. I never did need to worry about being stung, as I had no reaction to the stings other than the initial pain. I even knew how to remove the attached stinger without inserting more of the venom from the part left in my skin. I always carried the proper tool for removing them.

I admit that with the African killer bees, I would be very hesitant to get near them, even with the proper protective gear. I had the gentle Italian bees and often I would not wear protective gear when working with the hives. If I noted unusual activity or the drones were agitated, I would return to the shed where I kept the gear and become properly outfitted. When assisting other beekeepers, I always wore the protective gear and was happy to do so.

When this article appeared in WebMD, I was interested in reading it. For those that have never been around honeybees, please take time to read the article as it does cover some history and medical facts. The medicinal properties have been verified and while some people believe honey has more medicinal value than affirmed in the article, this is clearly not the case.

Please heed the warning about keeping honey away from infants. The botulism risk is real and young children are not capable of overcoming it. This is true for all forms of honey, even highly processed honey, but especially raw honey.

Honey is well known for its power in wound healing and skin ulcers. New Zealand has a product that has been FDA approved called Medihoney, which the FDA approved in 2007 for use in treating wounds and skin ulcers. Other types of honey are also used for wound healing, but seem less effective. They still aid in healing.

There has also been some studies done in the area of cough suppressants, but this is not as conclusive. “Maryland family doctor Ariane Cometa, MD, who describes herself as a holistic practitioner, likes to use a buckwheat honey-based syrup to ease early symptoms of a cold. She says it calms inflamed membranes and eases a cough -- the latter claim supported by a few studies.”

Beyond this, honey is a good food, which people with diabetes must use in limited amounts to avoid hyperglycemia. I still enjoy honey from a local beekeeper, but a jar lasts a lot longer and near the end needs to be warmed to melt the sugaring that takes place. There are some minerals and vitamins and antioxidant properties in honey. The darker the honey, the higher the level of antioxidants, however, I would not rely on this source as honey has more calories and carbohydrates than the same quantity of table sugar.

Avoiding Weight Gain If You Take Insulin

The myth about weight gain on insulin happens to be fact, although in reality it is muddied up by people. For people with type 2 diabetes, taking insulin can cause weight gain. There are several reasons for this. The one factor that comes to the front is people use insulin as the medication of last resort. Normally this is fought until there is no longer any choice, insulin cannot be postponed as blood glucose levels are out of control and oral medications cannot keep blood glucose levels down.

Because insulin is often the medication of last resort, two factors can cause weight gain. The first is inactivity or sedentary lifestyle. This may be caused by diabetic neuropathy, which makes it difficult to walk more than short distances. The second is people do not reduce the intake of carbohydrates when going on insulin.

Why is the second necessary? Because insulin is necessary, when first started, insulin makes management of blood glucose levels easier. Instead of losing some of your carbohydrates in your urine when your blood glucose exceeded your urinary limits, these carbohydrates are now put to work or stored as fat. This new efficiency in blood glucose management generally causes initial weight gain.

This is the main reason that people starting on insulin should consider reducing the total carbohydrate intake for a period of time while your body adjusts to the efficiency. However, if you are a person that is able to exercise on a regular basis and you do this, your carbohydrate intake may not be reduced greatly and may be resumed shortly after starting insulin.

Weight gain is always a possibility for some body types and people must learn to manage their carbohydrate intake to avoid weight gain. The article did say that you should limit your insulin dosage, which is only possible, if you reduce your intake of carbohydrates. I will also reemphasize their statement of using exercise to aid in insulin use to burn calories and help keep insulin use low. This will aid in preventing weight gain.

In conclusion, I will state that insulin should not be considered by people with type 2 diabetes as the medication of last resort. Learn about it before the need arises and before you have the neuropathy, which can make exercise more difficult. One tip you should also consider is possibly using Byetta, which will assist you in reducing your carbohydrate intake, and help you keep extra weight off and to assist you in losing some of the extra weight you have accumulated over the years. Talk to your doctor, as this needs to be understood before using it. Consider getting an appointment with an endocrinologist for using insulin to aid you in your management of type 2 diabetes.

Another Nail in the Wheat Coffin

It appears that even with the evidence staring them in the face (from their own wheat bellies) registered dietitians are not willing to eliminate wheat from their diet recommendations. This article in WebMD clearly shows the conflict they are having with wheat. They know that it is the cause of weight gain, but do not want to give up the calories and fiber that wheat supplies. Sorry people, you cannot have it both ways.

I doubt the author of the WebMd article has read “Wheat Belly” by William Davis, MD, but she should. Then she could be more confident in her knowledge of how wheat does affect us and the reason we need to avoid bread at all costs, and not just the highly refined wheat products she identifies. Healthy whole grains are not that different from refined wheat products, just a little more fiber in the whole grains, but no other health benefits. Both types of bread can be fortified.

Those of us with type 2 diabetes are aware of the effects of the carbohydrates in wheat so when authors change to calories to emphasize the value of wheat in a low calorie diet, we know that they do not have our health as one of their interests. They are still promoting wheat even though their own research verifies that it is part of the weight problem in so many people.

Then they try to side step the issue and put the blame on highly processed wheat, meaning white bread, crackers, pretzels, and other highly refined grains that have come to symbolize the struggle with weight control. Then they return to whole wheat as the high-fiber super food.

How diabetes ended up in the discussion seems so that they could again blame highly refined wheat as the culprit and claim that whole wheat is a help. They say that whole wheat is complex carbohydrates that take longer to digest and will not cause blood glucose spikes. Then the claim is made that whole wheat has more vitamins, minerals, and fiber. What is not said is that most wheat products are fortified whether they are highly refined or whole wheat. The other fallacy of the argument is that the vitamins and minerals in whole wheat can be had in other foods.

The only reasonable discussion is on celiac disease. There is not much they can do to promote whole wheat. There is a section on limiting bread, but even then, they say if you are eating bread, make it whole-grain bread and limit the amount. I recommend that you read the article in WebMD. They are trying to have it both ways and still promote whole-grain wheat bread.

Common Sense Still the Only Answer

Throwing money at a problem does not get improved results. This from a study about how hospitals have invested heavily in new heart attack care programs, yet only see a one (1) percent improvement in access to that care. This seems to be a problem for much of the medical community.

So what is the problem? Apparently, the distance people have to travel before they can receive the needed attention. So of course in areas of heaviest population, people near hospitals have the best opportunity to get the needed care, while in the most rural areas of our country, care is often not available within the time frame required to treat patients before damage is done.

It does not matter that the hospitals have spent large sums of money for heart attack care programs when people are not able to get to the hospitals in time. Once the damage is done, no amount of care will be able to completely reverse the damage. Very few people are going to move closer to a hospital just to be within driving distance for heart attack care.

The study only gave two possibilities for improved care and I have to wonder if this is the only best answer. Yes, I can agree with the proposal as being needed, especially for many areas of the US that need enhanced ambulance services and establishing well-positioned heart care programs in the more rural areas. The key is well-positioned programs. Many rural hospitals are near closing because of financial problems that will reduce the number of places for well-positioned heart care programs.

Where will the funds come from for these programs? This is of course not the position of the study to state. This is a problem that needs addressing in the months and years ahead. This needs to be resolved for more than just heart care, but for several other diseases as well.

This study does highlight one of the problems happening now and needs to be solved.