Did FDA Committee Make the Right Decision?

This will be hotly debated for the next several months. Many people are sure to be asking why now? What safeguards will be taken to prevent the problems that originally caused the limits to be put into effect? Even the original results when recomputed remained almost identical. Until the dust settles on the Food and Drug Administrations actions, we will only have a discussion as to the questionable value of Avandia.

I know several doctors that will start using it again; however, I doubt many patients will accept using Avandia. In my blog recently, I complained about the pill popper generations. I must expand this to doctors as most primary care physicians would rather prescribe pills than insulin. I am aware of many people with type 2 diabetes that are able to manage their diabetes on oral medications and many that are able to manage their type 2 diabetes without medications. Yet many patients need to stack one oral medication on top of another oral medication and still are not managing their diabetes.

Because many doctors are rightfully fearful of hypoglycemia, they will let diabetes do damage and become progressive before they will prescribe insulin. This is the shame of our medical teaching. Yet, not many can become diabetes doctors like Dr. Richard K. Bernstein.

The final decision now awaits the FDA. The FDA has no regulatory deadline by which to make a decision, and it's unclear when the agency will make a ruling, an FDA spokeswoman said. The FDA isn't obligated to follow the advice of its advisory committees, but usually does. Hopefully this time they will leave things alone.

So the wait begins.

Why Physicians Dislike Seeing Diabetes Patients

An article in Medscape caught my attention and to see two doctors (one an associate professor of medicine and the other an endocrinologist) discussing diabetes patients is very interesting. Do I think they are in error in their points? Not even, as they present some very valid points. Internist Matthew Mintz, MD, Associate Professor of Medicine at The George Washington University School of Medicine in Washington, DC, who blogs here is one of those doctors that I follow when he blogs. The other doctor is not one I am familiar with and it is Cyrus V. Desouza, MBBS, Chief of the Division of Endocrinology at The Nebraska Medical Center in Omaha. Note: To access the entire article, you will need to sign up for a free account if you do not already have an account with them. I have an account and obtain a lot of good information from Medscape.

This is one of the more positive discussions and deserves consideration. The author of the article, Neil Chesanow (Senior Editor, Medscape Business of Medicine) is the one person that discussed the objectionable aspect in the last paragraph. It is this and I quote, “The more incentivized your patients become to manage their condition and adhere to the regimen you prescribe, the fewer visits they will need to make to your office and the more likely you will be to catch emerging problems before they become serious.”

I was able to correspond with both doctors and they were not in agreement with the above quote. Both felt education is important and with education, the patients would be more willing to take ownership of their diabetes and do their best with the care plan outlined by the patient and their doctor. The error of the article author is also evident when he uses the registered trademark of a Bayer glucometer for the Sanofi-aventis meter that is iPhone-enabled, the iBGStar®.

In my conversation with Dr. Mintz, I brought up the idea of using telemedicine to which he stated, “I do not think; however, that they will obviate the need for face to face contact.” That was my thought as well for using telemedicine as this could help with education, but should not replace appointments with their doctor. Dr. Desouza was not available other than to answer two questions and I appreciate his time to do that.

In the article, Dr. Mintz is very clear about what can happen to primary care physicians (PCPs) when they have appointments with patients with diabetes. Normally he states that in scheduling patients for 15 minutes, many patients with diabetes may have other medical problems requiring more attention than 15 minutes will cover. Then you, as a doctor, are behind schedule and will probably be late in finishing the day.

Dr. Mintz does believe that when patient-centered medical homes and Accountable Care Organizations and their team approach to diabetes care come into existence in the next few years, this will improve the situation, but until then, scheduling will continue to be a headache.

The article lists the following as aids for PCPs in working with people with diabetes.

I will list the points and summarize the discussion.

#1. If Necessary, Upgrade Your Knowledge. Dr. Mintz says, "Expertise is often lacking because medical schools and residency programs don't teach enough about treating diabetes." Clinical literature for diabetes is an intensely researched disease and an admittedly formidable task.

Cyrus V. Desouza works closely with PCPs in the surrounding communities. He also sees basic gaps in clinical knowledge. "Confusion about diagnosing type 1 vs type 2 diabetes may exist," he concedes. "There may be inadequate knowledge of the standard of care. That's improving because of board recertification, but some of it is still there."

#2. Invite a Specialist to Give a Talk. Dr. Desouza advises PCPs to reach out to local endocrinologists for answers. He says a lot of PCPs may not know when it is time to refer a patient to a specialist. Dr. Desouza does take time to reach out to PCPs in the Omaha area that are affiliated with the academic center and give little talks. He feels this is important.

#3. Clarify What You Want a Consultant to Do. Dr. Mintz advises PCPs to be clear when asking for consultations. What does the PCP desire? Does he want the endocrinologist to give a consultant report, a suggestion(s) for the management of a complicated patient, or does the PCP want the endocrinologist to take the lead in managing the complex patient. This is where he says that PCPs are not proactive in what they are seeking.

#4. See if a Hospital Program Can Help. “Academic centers and other hospitals often have programs to help,” Desouza says. “In the Omaha area, for example, PCPs can send their diabetic patients to the Nebraska Medical Center when they need help with patient education.” The Nebraska Medical Center has certified diabetes educators (CDEs) for this, or a nurse could assist in titrating the dosage of insulin of a patient who is not meeting ADA guidelines. Patients with complex problems would be seen by an endocrinologist.

"Many academic centers have a case management or diabetes education system with sophisticated protocols and guidelines in place that are not available to PCPs," Desouza explains. Continuity of care is generally better, too, he says, "Because a PCP cannot see that patient every 4 or 5 days or even every month."

#5. Conduct Patient Education in Groups. I am happy to see a doctor actually recommend this. Whether in a hospital setting or a PCP office, educating a small group of patients can be more effective as this will allow the patients to interact. They will be able to learn from each other and this takes the time for education away from the time during the appointment. I will have more on this in my suggestions below.

#6. Build a Social Network of Consultants. This is important enough to quote. “Today there are fewer than 6500 board-certified endocrinologists in the United States, according to the American Board of Internal Medicine, and by 1 expert estimate, only about 1 in 6 is practicing full time. "It's a barrier to PCPs," Desouza concedes. "They are hesitant to refer because they know their patients might have to wait a long time to be seen." CDEs are rare too, and not generally available to doctors in private practice. Nor do nutritionists grow on trees.”

PCPs should ask themselves if they would do a better job and stay on schedule more often if, when you had a diabetes-related question, you could go online and receive authoritative advice. This could include questions on testing for diabetic retinopathy, titrating insulin dosages, or adjusting a patient's diet? If the answer is yes, social networking offers a way to build a do-it-yourself support system that may not be available anytime soon.

#7. Get Your Patients Involved Online Too. All too often PCPs forget about a way to make your life easier for their diabetic patients to play an active role in managing their disease. The Internet makes it easy and inviting to do just that. Social-networking websites offer patients with diabetes and other conditions virtual communities in which members can discuss symptoms, medications, side effects, diets, and other details about their health, as well as their favorite apps and devices for measuring blood glucose, counting carbs, etc.

In addition, online weight-loss and management programs for diabetic patients can supplement the care you provide. Many hospitals and insurers now offer them. Medicare also has a good program available.

The following are a few suggestions I would include that some PCPs should consider where they are comfortable in doing this. To supplement number 7 above, prepare a list of websites where your patients can find reliable information. Yes, this will require some time, but the resources are available.

Remote patient monitoring could be done for some of the more complex patients. This will require some extra time for your staff or yourself, but could be worth the effort to learn this now, instead of when required to do this later when penalties may attach for not doing this.

Telehealth or telemedicine may work for some patients that are managing their diabetes very well and only need to be seen for an A1c test or another medical problem, associated with their diabetes or not.

Shared medical appointments are what I was referring to in number 5 above. Select a group of people with type 1 or type 2 diabetes for the same appointment day and then where possible have them meet with office staff for education or use video conferencing where applicable with a CDE or other professionals. Encrypted video applications meeting HIPAA requirements are now available for use.

Peer mentoring or peer-to-peer workers are an area that is often overlooked. Evaluate your patients to find out which are very knowledgeable and would require minimal additional education to be able to work with other of your patients in educating them. Even if you needed to pay for their education by an endocrinologist, this may save the time during your appointments. The CDE's generally will not train them, as this is presently not on their professional list of things to accomplish. Studies have shown that peer mentoring or peer-to-peer works.

Question – Is Avandia Safe?

This is an interesting conundrum for the FDA. Or at least it will be if they lift the restrictions on Avandia. Avandia is in the class of oral diabetes drugs Thiazolidinedione.  Avandia and Actos are the only two drugs in this class. Avandia is the product of GlaxoSmithKline (GSK) and Actos is manufactured by Takeda Pharmaceuticals. Avandia is known for causing heart problems and Actos has a raised incidence of bladder cancer. If restrictions are lifted on Avandia, will we find out that it too will raise the incidence of bladder cancer?

Although the big guns on both sides of the argument are not being quiet, I can well imagine that if the FDA lifts the ban on Avandia, the FDA will have to weather the storm of being accused of being too chummy with Big Pharma. Even I would be remiss in not considering this charge. All too often, I feel that when there are questionable trials and data, FDA approves a drug when it should require additional studies.

While it is true that most drugs have side effects of some type, in the last decades, too many drugs have made it to market and later had to be removed because of either something that was kept from the FDA, or something overlooked by the FDA. I will pull no favoritism because I feel that Big Pharma is laughing up its sleeve and saying to the FDA, "heads, I win, tails, you lose." Then on the other side, we have the patients screaming at the FDA for its slowness of approval for drugs they feel would help their disease.

If those of us with diabetes did not have insulin available, then I could possibly understand the need for oral medications with dangerous side effects. I am not in favor of this because too many in my generation and the next generation are pill poppers and if they have an illness or in this case a chronic disease, all they want is a pill to pop in their mouth and go on with life. Is it any wonder that diabetes becomes progressive for many people? They won't learn how to manage diabetes and many won't learn because they have that pill to take.

For those that have not followed the Avandia debate, this is where it started for me and now that the two-day session is in progress (June 5 and June 6), it will be interesting to read about the outcome. The second article is here by Dr. Matthew Mintz. The latest article is from the digital side of the New York Times and you may read it here.

Now, this evening (June 5) there are two more articles that could make an excellent read.  Before reading this blog by Dr. Mintz, but sure to read the one above.  The second is an article in Forbes dot com.

Safe Use of Insulin Vials

The Institute for Safe Medication Practices (ISMP) changes their mind again and is now urging hospitals to return to insulin vials and syringes and migrate away from the use of insulin pens in hospitals. This I can understand and appreciate as hospital personnel are nefarious for not following safe practices and creating cross patient contamination.

This is off topic, but the last time I was in the hospital, I lost count of the number of medical personnel that came by to listen to my heart and breathing. Did they clean their stethoscope before using it on me? Did they clean it before using it on the next patient? I cannot answer this positively, but the two times I asked, the doctor hesitated and said no. He asked why I asked, and I quickly said MRSA contamination. Then I next asked a nurse and was met with dead silence. I repeated the question and again received no answer. I then commented that it was no wonder we as patients needed to be concerned about safety and cross-contamination from other patients. This set off a litany of comments about patients not understanding medical procedures and should not be questioning their procedures.

Yes, we as patients need to be aware of the lack of safety procedures that are not practiced by our hospitals. Until hospital boards are faced with multimillion-dollar lawsuits for causing patient deaths, little with change from the top down. I emphasize top down, as there is no incentive for hospital staff to be concerned when policies do not come from the hospital boards to the administrators and then the department heads. Most often the staff is not made aware of good procedures and is told to be more careful to cut costs where possible. They see this as reusing needles for patients after patient, and creating cross contamination with both needles and insulin vials.

In this case, the Institute for Safe Medication Practices may be just flapping their gums, as without support at the highest levels of our hospitals, little will happen. I do give the ISMP good marks for recognizing some of the more egregious errors by hospital staffs. Hopefully the Centers for Medicare and Medicaid Services (CMS) will be able to aid in enforcement of some procedures.

I fear that the example used in the article may become commonplace and more deaths will occur. Most hospital staff is not aware of the distinction of insulin syringe and other parenteral syringes used by the hospitals. Medication errors will probably increase many times before the staff is made aware of the problems happening.

For patients entering the hospital, do everything in your power to discern the procedures followed by the hospital and if not an emergency hospital entrance, get as much in writing as possible allowing you the right to manage you own diabetes if possible. Do not trust this to the hospital for your own well-being.

ADA Relies On Faulty Studies, Not Good Advice

I wish I could copy all of the reasoning in this one file, but that would make for a long file. Dr. William H. Polonsky and Dr. Lawrence Fisher have some excellent points about self-monitoring of blood glucose (SMBG). The points run counter to the entrenched position of the ADA “experts” which rely on what I believe are faulty studies. I refer you to this blog from April 9, 2012. To read both sides of the point-counterpoint, you will need to download this file using Adobe Reader or a PDF compatible reader.  If you have one, clicking on the link should download it for you.

Yes, I am writing many blogs on self-monitoring of blood glucose (SMBG) and diabetes self-management education (DSME) because of the lack of support for this from the American Diabetes Association (ADA) and the American Association of Diabetes Educators (AADE). They both are using “feel good” hype, but doing nothing to turn words into actions. The AADE and ADA both participated in the development of National Standards, but do not have the personnel to make it a reality. In other words, they are ideal intentions, but no actions are taken to make it a reality.

The AADE is wrapped up in their own importance to the point they can't bare to see lay people even trained to assist in DSME. Yes, lay people (or better yet lay people with diabetes) could be trained to be able to give DSME as peer mentors or peer-to- peer workers with supervision, but this beyond the desires of AADE. They have to protect their position in the diabetes hierarchy. They are afraid that like the few studies have shown, people respond to fellow people with diabetes better than people that issue mandates and their only diabetes knowledge is what they have learned in books.

People with diabetes are generally open to listening to other people with diabetes that can speak to them at their level and not at the lowest common level that CDEs are prone to do. Every time I hear this from people that have met with CDEs, I know that they did not do the assessment they are supposed to do. They were only interested in making a few points and getting out rather than do what is required by their own policies and procedures. This says there is a disconnect between the upper levels of the AADE and the CDEs working in the field. This disconnect is almost large enough to say that there are two organizations, the AADE and CDE and each highly disregards the other.

This makes what Drs. Polonsky and Fisher even more important as they can see the value of SMBG and what the education would mean to people with type 2 diabetes. Yet, they see what the studies are doing that the ADA relies on and can see how they are set up to give predetermined results by asking the wrong questions. You don't have to rig the results if you carefully ask the wrong questions. You know that insurance has something to do with this and the National Institute of Medicine has to be involved.

Yes, I can see the USDA and their experts being involved in some of this because they don't want people to be testing and finding out how bad the nutritional information is that they are promoting through the ADA. In almost 100 percent of what we read about nutrition or food plans for people with diabetes, no mention is ever made of using our blood glucose meters to test what the different foods do to our blood glucose. This means that someone has a vested interest in not mentioning this as then there would be more available education for people with type 2 diabetes and more reason to have testing done.

Drs. Polonsky and Fisher state the following and discuss each.

1. Recommended frequency and timing of SMBG must be adequate

2. Patients need to be knowledgeable about SMBG and have the necessary skills to use SMBG data

3. Clinicians need to be knowledgeable about SMBG, actually see the SMBG data that patients collect, and have the necessary skills to use the SMBG data

4. SMBG data must be collected and recorded in a manner that permits blood glucose patterns to be readily observable and easily intelligible for clinicians and patients

5. Further concerns about study design
   
   
6. Conclusions

In the conclusions, Drs. Polonsky and Fisher clearly state how easy it is to arrive at the consensus the ADA arrived at by asking the wrong questions. A number of studies that Malanda et al. Explicitly excluded from their review have explored innovative ways of using structured and targeted SMBG testing for this patient population effectively, and have shown significantly reduced A1C, depression, and distress, and enhanced diabetes self-efficacy. The doctors feel that rephrasing the research question and retargeting studies to evaluate the specifics of effective use of structured SMBG are warranted.

Drs. Polonsky and Fisher clearly feel that asking the right questions and doing the studies properly would yield different results.

Personal Observations

The last few weeks were somewhat of a blur for me. I was still upset that I could have caused the group to fracture in different directions, which fortunately it did not. I received an invitation to the new group which I politely refused and then pressure to join their group. Since I had politely refused, I did not feel bad about shutting off my cell phone and deleting their emails. It was more difficult avoiding them entirely so I finally asked them to stop, as I would be staying with the group.

For the number of people in our local community with diabetes, both types, and now one with LADA, more that two groups does seem to have a place. This is very good in a way. Plus this puts doctors serving members of our community on notice that they need to become more familiar with diabetes and follow guidelines that are more current. Our group has been approached by the local doctor of the doctor led group about why we are staying outside of the official channels. We did ask the doctor advisor why he opposed our group so vocally and he refused to answer. We clearly told him that we liked being able to read the guidelines of the different medical groups and compare them without worry and that all of us did not wish to be dictated to by other professionals. We did not wish to follow their teachings when we were able to discern for ourselves what worked for us.

When he asked to address our group, emails were rapid and everyone said no. We asked him what the lowest A1c was for his group. He admitted he did not know and we stated that our group had several just above 5.5% and one at 5.2% with the highest one at 6.3%. The doctor said he doubted many of his group was near 6.0% and we said that was the reason most of us would not join his group and that of the 14 current members, 12 were now on insulin. We felt that with this, we would have little in common with the group he led. He agreed that he had not realized so many of us were on insulin, and that the two groups were probably better being separated since we were doing so well on our own.

He did ask if we as a group were having many problems with hypoglycemia. I asked what level he considered us to be in hypoglycemia. The doctor said anything under 80 mg/dl. At this point, the three of us meeting with him laughed and asked if he was aware of the joint group from ADA and The Endocrine Society that declared hypoglycemia at 70 mg/dl and he was not. Tim opened his laptop and this link. He quickly skimmed the article, asked Tim to send him the link, and gave Tim his email address. I answered that most of us did not get too concerned with readings down to 60 mg/dl, but that once it went below 65 mg/dl, we were taking actions to correct the levels, with either glucose tablets or certain foods or drinks from this list.  Tim then opened my blog about the diabetes algorithm and the doctor asked for that link. 

The doctor finally admitted that we probably knew more than many of his group ever would and thanked us for letting him know that as a group we did so much research. We thanked him and told him that someone from our group was always available to speak to his group about insulin and the advantages of insulin over oral medications. He said that he would honestly keep this in mind.

The doctor asked about the two members of our group that were not on insulin and we stated that one had just been diagnosed with prediabetes and was taking metformin ER presently and his wife had type 2 diabetes. She had been encouraged to develop lifestyle habits that got her off all medications and had been for some time now. We said that we are working with him to get off all medications and he is hoping that he can delay diabetes for many years. He was surprised and said that we did not encourage either to go on insulin. Tim said no, as we do with all members, but we discourage anyone from staying on most oral medications other than metformin because of the side effects and problems many are causing.

I gave him the classes of oral medications, those that were under close watch by the FDA and asked him which were acceptable now. He listed them and I said that two of our group was allergic to sulfa and therefore the sulfonylureas were out for them. The remaining class required close monitoring because only glucose tablets were recommended for treating lows because they slowed foods going through the stomach. At that point, the doctor stated that as long as we were teaching each other this information and knew what we did, he was happy that there were two groups. We corrected him that there were now three groups and the third one was as a result of our group splitting. They were all on oral medications and had come from the doctor that did not want his people testing. He made no comments about this, but we could tell this upset him as well.

He thanked us for our time and wished us success. He then stated that he would consider asking us to speak about insulin in the future since we were well versed about it and were meeting as a group. He admitted he had not realized we were so many in number, but that was a good thing. I told him that five of us were using the VA for our medications and this brought him back. He said he thought two of the group he led were or should get their medications from the VA. I quickly told him to have them go to the VA office at the Courthouse lower level and talk to the VA officer and she could get them started if they qualified. He said that maybe he should stay in contact with us and meet with a few of us on a quarterly or semiannual basis. He stated he had learned more than he anticipated and anything that could help his group was welcomed.

After he had left, Allen stated he was surprised we had said so much. Tim stated that he had thought about it and decided that we should and see where it went. He said that with so many opposed to him speaking to our group, we needed to sound him out and exchange ideas. I said it may now be a good thing to have him speak to our group since he knows that so many of us are on insulin and that he was not welcome in his first attempt. Tim said that was also his reason for discussing so much with him and by having his laptop available, we should have impressed him with our knowledge and research. This also let him know why our members were not interested in joining his group.

Tim concluded that he would press him to have as least two of our group address his group and since we now had his email address, he would attempt to stay in contact with him. I told Tim that I agreed and like it or not, we should consider having him as a speaker in the near future. Allen was hesitant, but said he would think about it. He did admit being surprised about his reaction to so many of us being on insulin. I said this would not be something he would want for his group since all were on oral medications. Tim said that was the dividing line and this was a good thing. With that we went our separate ways for the day.