January 23, 2016

Doctors That Receive Money from Manufacturers

Why researchers only researched the last five months of 2013 for this is somewhat of a puzzle unless they also had an agenda. Internal medicine and orthopedic surgery received the greatest total value at $111 million each. The highest proportion of physicians receiving payments was seen among cardiovascular and neurosurgical specialists.

Jona Hattangadi-Gluth, MD, principal investigator and assistant professor at UC San Diego School of Medicine stated, "Physicians across the nation have entered into an era of transparency. This analysis shows the wide variability of industry payments across specialties. The research sheds light on how physicians are engaging with medical companies, and this information can be used by patients, policymakers and other stakeholders when making health care decisions."

The study found that medical specialties requiring a higher level of intervention, such as gastroenterology, cardiology and orthopedics, received higher payments - likely because of the dependence on devices used by the physicians for procedures, such as stents or hip replacements.”

"During the last few decades, physicians have become much more engaged in the development of novel drugs and devices, which is critical to bringing innovation to patients," said Hattangadi-Gluth, chief of the central nervous system tumor service at UC San Diego Health. "Certain specialties, like surgery, may require more research and involvement in device development, resulting in higher royalty and license payments. Our study not only identified how industry payments are distributed by specialty, it also helped put those payments in context."

When you use the search tool on the open payments site, you will enter the first and last name of the physician and you will be able to see industry payments to the individual listed by company, nature of payment, date, and amount. Using this information, the determination needs to be made if the financial relationship creates a conflict of interest or are they appropriate to ensure the highest quality of care and patient trust.

Hattangadi-Gluth said next steps include looking at whether an industry payment affects physician decision-making and treatment utilization. We don't know yet whether these financial relationships are harmful in any way. It is also unclear whether transparency will impede valuable collaborations and the pace of innovation. There are many positive consequences of physician-industry relationships, so it is important that they be interpreted properly."

This is probably the hardest decision for the patient to determine. I have been very careful to ask one or two questions of the doctor and base my decision on how the doctor answers. For one doctor, I knew he had been the one that developed the device and if figured that payment was a royalty, and when he answered the explanation fit. For the second question, he was a little more evasive, so I asked another question about having a conflict of interest. Finally, he admitted that it was and he received a payment for every time the company was reimbursed for the device.

January 22, 2016

One Less Diabetes Organization

This is a follow-up of the last blog that I ended with the note that Dr. Bill Quick says the Academy of Certified Diabetes Educators is now defunct. Dr. Quick says this is one less cook in the kitchen. I can't say I'm sorry that this has happened. This is good news in several ways as this means that we will not need to deal with an organization that has been taking the exclusive route. Now we will also not need to be concerned when the AADE, AND, and ADA are issuing joint statements and wonder why ACDE is not mentioned.

On December 27, I blogged about the problems with the website and lack of activity. At least now, I have an answer, thanks to Dr. Quick.

This does not solve many problems for those of us with type 2 diabetes and for those of us in our support group, it has possibly added to our problems. We are finding that we are being sabotaged by the dual title RD/CDEs and we don't appreciate this as a support group.

The support group has gained support from the insurance companies and the quicker the CDEs realize this, the better off everyone will be. My cousin will not have her 1,000 hours in for some time and will still have her test to sit for and pass, but we now know that she can start her 1,000 hours next month which is a big plus for our group.

So shortly, we will be able to obtain some valuable diabetes education. Yes, we may need to travel 35 miles one way, but the education will definitely help. Several of the members are talking about doing some traveling together to save on travel costs, and this is another positive.

I have been in contact with my cousin and informed her that we were waiting and would like a schedule as soon as it is reasonable. She does say that the CDE that Tim has seen is available and would be involved in her training. I referred this to Tim and said that Alice should possibly consider this. Tim said he would discuss this with her and two others.

January 21, 2016

Reasons for Ignoring Diabetes Education

Riva Greenberg starts a great blog, but then ends it by asking questions of the past AADE President Deborah Greenwood, PhD, RN, BC-ADM, CDE and the 2016 President Hope Warshaw, MMSc, RD, CDE, BC-ADM. Notice the multiple titles and especially the current president of RD, CDE. The past president is an RN, CDE.

This means that the RD will be emphasized to CDEs and other dual titles. Our support group has been wondering if we would have more luck in 2016 to receive diabetes education, but with this president, we do not think this will happen.

Most of our members are tired of going to an appointment for diabetes education and not receiving education, but nutritional advice of low fat, high carbohydrate advice, which the insurance won't pay for when they only approved for diabetes education. Most of us get the standard mandate of whole grains and 45 to 70 grams of carbohydrates per meal. Yet, the RD/CDEs insist that they should be teaching nutrition. Or, they give out mandates of getting more medication to cover the carbohydrates consumed and they tell the doctors to up the dose of medication or add another medication. So typical of CDEs that do not understand the value of low carb, high fat, moderate protein food plans. This means we don't need a higher dose of medication (insulin or oral) and do not need to add another medication.

We have had discussions with our insurance company and they are happy with the cost savings that have happened of the last few years and have now accepted Suzanne and Allison as nutritional advisers for most of us and they see the nutritional benefits in the different test results and cost savings. The insurance company has also allowed splitting the two hours they require, as they know we obtain more benefits by using this method.

After several complaints about CDE/RDs only teaching nutrition, the insurance company sends a letter that they will only pay for diabetes education and not to submit if they did not teach diabetes education. All CDEs have canceled when this happens. Most know that we have our own nutritionists and that the insurance is paying them and they don't like this and want to use up the time when possible.

In addition, we are now asking the CDEs to teach Self-Monitoring of Blood Glucose (SMBG). Since they do not want to teach the importance of testing, they have told the doctors that the ADA advises that well controlled diabetes do not need to test, but rely only on the A1c. This is thanks to Dr. Robert Ratner, chief scientific and medical officer for the ADA.

This is one reason we think that CDEs need to be ignored and not allowed to give bad education in the form of mandates, mantras, and dogma.

Now I suggest you read a blog by David Mendosa that has a different approach about CDEs and DSME. It is different and more positive than mine is. My blog reflects what our support group members have experienced.

Important NOTE:  According the Dr. Bill Quick's website, the Academy of Certified Diabetes Educators is now defunct.  Dr. Quick says this is one less cook in the kitchen.  I can't say I'm sorry that this has happened.  Too many things were not being covered and this leaves the AADE back in charge of CDEs, which basically means doing nothing for people with type 2 diabetes and prediabetes. 

January 20, 2016

CDC Reports Half of Eligible U.S. Adults Don’t Take Statins

This may be the best thing for them – see my blog here. I will be ditching statins over the next 45 days and I will not let a doctor convince me otherwise. In researching for the blog above, there were many articles on statins causing hardening of the arteries. Yet, the endocrinologists and cardiologists will not give them space on their websites. In a recent conversation with a cardiologist, when I mentioned this, he wanted to know where I read this and asked for URLs that I could email to him.

I did hear back from him and he said that he would need to rethink his policy of prescribing statins. He was gracious enough to say that he had not heard of these studies and even though most were behind paywalls, he did access them and was very surprised at what was in several of the studies. In the email, I did ask if he were able to read a couple of them, would he email me a copy. He did and for that I thanked him.

We have continued our discussion over the last several days and he thanked me for my blog referenced above and for including the statements by several doctors. While he was aware of Dr. Malcolm Kendrick's book “The Great Cholesterol Con”, he had not read it and with the URLs I had sent him, he had ordered the book.

I also asked him about the newest statin, the PCSK9 class. With our discussion, he said he would be in correspondence with Dr. Kendrick after reading his blog on this and reading my three blogs on the new drugs. He is not sure about prescribing presently, but stated he does have one patient that has asked about them and the patient fits the criteria, but he told the patient to wait.

Then he asked me for the results of my last lipid panel, which I sent to him. I received an immediate reply asking me how I had achieved the low levels for LDL, triglycerides, and a good reading for HDL. I said my way of eating and not following the food plan many registered dietitians push of carbohydrates and whole grains. I said I follow a low carb, high fat food plan with moderate protein. I eat lots of eggs and cheese that is not highly processed. I like sausage and bacon and I choose other high cholesterol foods that are not highly processed. I read food labels, ingredients, and avoid many canned foods except green beans and use a lot of dried beans that we use the pressure cooker to put moisture back into the beans. He asked how many carbohydrates I consumed per day. My answer was 30 to 50 grams per day and it varies by what I decide to eat for the day.

He commented that he had two patients eating very similar food plans and he said this must be why their lipid panels are always so good. He said he needed to stop for now, but that he would be back with more questions.

I have strayed from the topic so I will have to think about whether I really want to blog about the CDC saying half of eligible U.S. Adults don't take statins.

January 19, 2016

Other Reasons for Drug Non Adherence

When I wrote this blog on November 6, 2015, I used the reasons promoted by the American Medical Association (AMA) and they are valid reasons. Now I will list more reasons that I feel most doctors refuse to consider.

These are the reasons I feel should be considered:
Communication improves health outcomes. My blog here helps explain this and would reduce drug non-adherence greatly. Without communication, patients may not understand what the medication is for and do not know what side effects may happen and this will increase non-adherence.

Not understanding patient's finances. This is often not a consideration for doctors and they prescribe the more expensive drugs rather than generics. Yes, this can be like cost in the previous blog, but I want to emphasize that too often doctors only care that their bill is paid and too often prescribe an expensive drug they can receive incentives for prescribing.

Patients looking for natural treatments. This is the bane for all doctors, but they need to understand these people. They do not care how large the fistful of prescriptions might be. They just accept them and as soon as they are out of the office, they stuff them in a pocket or purse and they are off to visit the nearest health store to ask questions and see what the salesperson recommends. Or, they are looking for something a friend or relative recommended.

Patients looking for a quick fix and get out the door. These patients think that a doctor is like an auto mechanic. A little bottle of medicine here, and a shot there, and they will be as good as new. Even many patients with diabetes do this and feel that this is the twenty-first century and there has to be a cure. Some even accuse their doctor of hiding this from them.

Patients that have a symptom for everything. They will not let the doctor go until they have explained the symptom (most of the time may be non-existent) and try to convince the doctor to investigate by doing this or that test. These patients can easily be classed as hypochondriacs. They are the dread of every doctor. When the doctor suspicions that they don't have the symptom, they often accuse the doctor of not staying current in his education and become belligerent.

There could be many more, but these and the prior blog cover many reasons for patient non-adherence. Some are definitely the fault of doctors and others are the fault of the patient. I will always blame lack of communication the chief culprit and doctors do not like this. I have asked a doctor for a generic and was told that the generic was inferior in quality. As I was leaving, I quipped that he would not receive money for the generic. I received no answer and talked to the pharmacist who called and was told that he had prescribe the brand name for a reason.

She then said he will not let me fill the prescription. I told the pharmacist that I would see another doctor and see if he would prescribe the generic. She suggested two doctors and when I said one of them, she called to see if he would be able to see me the next day. When she had the appointment, she told the doctor I was taking a medication and gave him the brand name and the generic name. She gave me the office number, location, time and generic name and said he would give me the generic medicine.

January 18, 2016

FDA Approves Matrix to Treat Diabetic Foot Ulcers

The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers on January 7. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

With an estimated 29 million people in the United States that have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and about 25 percent of them will experience a foot ulcer during their lifetime. Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year.

We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”

The FDA first approved Integra Dermal Regeneration Template (which the company now also calls Omnigraft) in 1996 for the treatment of life threatening burn injuries when the use of a patient’s own skin for a graft was not possible. In 2002, Integra Dermal Regeneration Template was approved for a new indication to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts. Now, Omnigraft is approved to treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care.

Adverse events observed in the clinical trial included infections, increased pain, swelling, nausea, and new or worsening ulcers.

Omnigraft should not be used in patients with allergies to cow (bovine) collagen or chondroitin (cartilage from any source) since serious allergic reactions may occur. Omnigraft should also not be used on infected wounds.

Omnigraft is manufactured by Integra LifeSciences Corporation of Plainsboro, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

January 17, 2016

Is the CDE Profession All but Done?

With all the conflicts of interest that CDEs have, it is surprising that anyone receives diabetes education. The ACDE website still has its problems and has not seen fit to correct their website. Apparently, they have many members that also have the registered dietitian title as they are offering continuing education in nutrition.

The more CDEs in both organizations expand into the registered dietitian profession, the less we need to consider them certified diabetes educators. Our support group has had some very problematic sessions with dual titled CDEs/RDs and we will not accept working with them because there is very little diabetes education and mostly faulty nutritional information. This we ignore from them and we do this because most of us use the low carb, high fat meal plans of varying degrees and we will not eat the whole grains and the number of carbohydrates they insist we consume.

In addition, the AADE is attempting to become the only group that can do diabetes education. Many people with diabetes do not like this and feel that our choices would be limited to unacceptable levels. At least some of the doctors in our area are not using them, especially if they have the dual titles. Our support group has even thanked a few of the doctors.

Many CDEs find ways to excuse themselves when depression is mentioned and this has most of us wondering why. Only one of the CDEs we have met started an assessment and then communicated with a doctor about this to have the patient taken care of properly. When this happened, we could appreciate her efforts and that fact that she did not excuse herself and leave.

We have also discovered that most CDEs want to ask about the meal plans we use. Then we are lectured about the lack of whole grains and carbohydrates we consume and that we are eating too much fat. Even though they don't go into nutrition and that we need to eat a certain number of carbohydrates, they still urge us to eat low fat and consume whole grains. And, it doesn't matter that one of the group has celiac disease, they push a one-size-fits-all way of living.

Even our honorary type 1 member has been ordered to eat whole grains and more carbohydrates and instructed to just cover them with insulin. She is the only one that she is aware of that has not gained weight during her first semester of college. All of this was stated by a CDE. Then the CDE reported this to one of the college doctors that asked her to come in for an appointment. Once at the appointment, the doctor ordered many tests and after the results, the doctor asked if she knew why she had been called for an appointment. The doctor did not wait for an answer, but explained that from the test results, he could not agree with the CDE that she would be malnourished. The doctor continued that even though she was eating low carb, high fat, her tests all showed that she was in the ranges for all of the tests and that she was not deficient in any way.

The doctor then commented that she was the first person with type 1 diabetes that he had seen that had not gained weight in their first semester and as long as she continued on her food plan, he wanted to see her on a twice a year basis to follow her progress and he felt she was doing something that he wanted to learn more about. She told the doctor she would, but felt the doctor should talk to her nutritionist who was also helping her and supply her with copies of the test result. The doctor agreed and thanked her for being willing to participate.