Low-fat Diet Not Most Effective for Weight Loss

It is great to see headlines like this, “Low-fat diet not most effective in long-term weight loss.” Researchers conducted a systematic review of randomized clinical trials comparing the long-term effectiveness of low-fat and higher-fat dietary interventions on weight loss. The effectiveness of low-fat diet on weight-loss has been debated for decades, and hundreds of randomized clinical trials aimed at evaluating this issue have been conducted with mixed results. Mixed results because of setting up the studies for short periods of time and often using individuals that could easily lose weight.

Researchers from Brigham and Women's Hospital (BWH) and the Harvard T.H. Chan School of Public Health (HSPH) conducted a comprehensive review of the data generated from randomized clinical trials that explored the efficacy of a low-fat diet and found that low-fat interventions were no more successful than higher-fat interventions in achieving and maintaining weight loss for periods longer than one year. These results are published in The Lancet Diabetes & Endocrinology on October 30, 2015.

"Despite the pervasive dogma that one needs to cut fat from their diet in order to lose weight, the existing scientific evidence does not support low-fat diets over other dietary interventions for long-term weight loss," said Deirdre Tobias, ScD, a researcher in the Division of Preventive Medicine at BWH.

"In fact, we did not find evidence that is particularly supportive of any specific proportion of calories from fat for meaningful long-term weight loss. We need to look beyond the ratios of calories from fat, carbs, and protein to a discussion of healthy eating patterns, whole foods, and portion sizes. Finding new ways to improve diet adherence for the long-term and preventing weight gain in the first place are important strategies for maintaining a healthy weight."

According to the researchers, "The key is to improve long-term compliance and cardiometabolic health. Therefore, weight loss diets should be tailored to cultural and food preferences and health conditions of the individual and should also consider long-term health consequences of the diets."

While I can agree with part of this, we need to get away from the word diet, which always leads to failure, and consider this a lifestyle change and a way of eating to have success. Normally, a low carbohydrate and high fat (LCHF) way of eating should achieve weight loss and help maintain this loss of weight.

Yet, most dietitians and the organizations they belong to, insist on whole grains and high carbohydrate diets that can't be sustained because of the weight gain that results.

The members of our diabetes support group are happy that we have two nutritionists that are not members of the Academy of Nutrition and Dietetics (AND) or the American Society of Nutrition (ASN), which are the tools of Big Food. We are learning about LCHF and balancing the daily nutrition. They also encourage each of us to be careful not to increase the amount of protein in our meal plan unless the doctor approves this.

Eight Reasons for Drug Non Adherence

Drug non adherence (or non compliance) is a topic few people want to talk about, except doctors who rail about patients that do not take their medications. In my blog here, I summarized it this way - I have an easy answer for them and I don't need over 30 pages to tell doctors the problem. Learn how to communicate with patients rather than ram medications down our throat. Most of the time, these doctors just hand the patient a fist full of prescriptions with no explanation and expect the patient to fill each prescription and take the medication as directed.

Now we have an article by the American Medical Association listing eight reasons patients don't take their medications. Data show about one-quarter of new prescriptions are never filled, and patients do not take their medications about 50 percent of the time. Most non adherence is intentional: patients make a rational decision not to take their medicine based on their knowledge, experience and beliefs.

The top eight reasons for intentional non adherence are:

1. Fear. Patients may be frightened of potential side effects. They may have witnessed side effects experienced by someone else that was taking the same or a similar medication and believe the medication caused the problems.
   
   
2. Cost. Patients may not fill medications in the first place or ration what they do fill to extend their supply.
   
3. Misunderstanding. Patients may not understand the need for the medicine, the nature of the side effects or the time it will take to see results. This is particularly true for patients with chronic illness, because taking a medication every day to reduce the risk of something bad happening can be confusing. Failure to see immediate improvement may lead to premature discontinuation.
   
4. Too many medications. The greater the number of different medicines prescribed and the higher the dosing frequency, the more likely a patient is to be non adherent.
   
5. Lack of symptoms. Patients who don’t feel any differently when they start or stop their medicine might see no reason to take it.
   
6. Worry. Concerns about becoming dependent on a medicine also lead to non adherence.
   
7. Depression. Patients who are depressed are less likely to take their medications as prescribed.
   
   
8. Mistrust. Patients may be suspicious of their doctor’s motives for prescribing certain medications because of recent news coverage of marketing efforts by pharmaceutical companies influencing physician prescribing patterns.

Unfortunately, the AMA is not concerned about communication with the patients and only interested in improving medication adherence. They have a free online module that includes practical strategies and tools that doctors can implement. The module also includes information about how to get support for intervention implementation, and it offers continuing medical education credit.

Many Elderly Need Less Medications

Many studies are finding that the elderly are over medicated. Two studies recently pushed the numbers at us and how few doctors will decrease medications.

1. Based on Veterans Affairs primary care data on older adults with longstanding diabetes, deintensification of hypertension therapy, not including angiotensin converting enzyme inhibitors (ACE-I) amongst patients with moderately low and very low blood pressures (BP) occurred less than 20% of the time.

2. Similarly, deintensification of diabetes therapy, not including metformin, amongst the same population with moderately low (HgbA1c 6-6.4%) and very low (HgbA1c less than 6%) blood sugars occurred less than 20% of the time.

This does not speak well for our doctors and may mean that they are more interested in piling on medications to the harm of patients. I will say that patients need to be proactive in their medications. I have been able to have the VA reduce my medications and after looking at the test results, they had no trouble lowering the dose I am taking. Fact is the physician thanked me for bringing this up.

With the shortage of studies that include testing for the elderly, it seems that for many people over 70 years of age, it might be safer to consider reducing medications. I like the word deprescribing that was first brought to my attention in a blog by David Mendosa on September 08, 2015. His blog has a different challenge, but it still needs to be said.

The two new studies published in JAMA Internal Medicine suggest doctors and patients should work together to deprescribe such treatment more often. In people 70 and older, very low blood pressures and blood glucose levels can actually raise the risk of dizzy spells, confusion, falls and even death. The consequences can be dangerous.

In recent years, the experts have started to suggest that doctors ease up on how aggressively they treat such patients for high blood pressure or diabetes, especially if they have other conditions that limit their life expectancy. What needs to be added is when older patients have decreasing cognitive abilities, this should be when medication needs a complete review with the goal of reducing medications.

Jeremy Sussman, M.D., M.S., lead author of the study that used medical records, stated, “Every guideline for physicians has detailed guidance for prescribing and stepping up or adding drugs to control these risk factors, and somewhere toward the end it says 'personalize treatment for older people'."

It may be hard for an older person to recognize the signs of too-low blood sugar, such as confusion and combativeness, or of too-low blood pressure, such as dizziness. Meanwhile, keeping up with taking multiple medications, and checking blood sugar daily or even more often, can be a struggle for the oldest patients. De-intensifying or deprescribing their treatment can often be a relief, if their treatment is personalized.

Would You Give Up Your Privacy for Free PCSK9 Copay Card?

This is what Amgen is asking people to do and for a very few, this might be something to consider. For the rest of the people, privacy should be carefully guarded. Amgen feels that its extremely expensive new cholesterol drug, Repatha, is worth surrendering your privacy.

“Doctors, pharmacists, patients, and others are now starting to learn that in order to receive financial assistance from Amgen for its expensive new cholesterol drug Repatha, patients are being required to surrender rights to their personal information, including their personal health information. The information will be freely available, with few restrictions, not only to the company, but to unspecified third parties.”

Marilyn Mann, a respected patient advocate who has family members who have familial hypercholesterolemia, suggests the policy be revised so that patients in financial need can receive assistance without having to agree to such a wholesale waiver of their privacy rights.

The Repatha copay program is part of the larger Repatha Ready program, which supplies "support services to help you start and stay on Repatha." They don't want to lose their lucrative profits. The supposedly most important part of the program is a copay card which gives patients access to the drug for only $5 a month. The program includes email reminders and a free needle-disposal (sharps) container. For patients to receive this, they must first sign over their rights to privacy to Amgen to use their personal information.

Some of the language should scare you. “I understand that Amgen may use my personal information, including my personal health information, for 10 years once I accept this Authorization or for a shorter time period if required by state law.” The agreement specifically states that by agreeing to the terms, patients may lose federal HIPAA protection. Further, the company specifically warns that there is nothing to prevent it from sharing your information with third parties:

Copay cards are normally used by patients to offset their out of pocket costs, and the companies used them as promotions to gain and maintain market share for the long term to maintain profitability.

The Amgen plan seems to be taking a different approach. They are seeking market domination and a novel data source. The use of patient data might well be part of the broader strategy to find more patients by mining new sources of data. This move by Amgen represents the next step in the merger of digital technology and biotechnology, i.e., if you' re not paying for the product, you are the product.

With your personal information, they can sell this to other companies looking at patient data-mining and you, as the patient will be bombarded with information to convince you that you need their products.

To this, I say – NO THANKS!

You may want to pass this information on to friends who may be at risk for diabetes.

Doctors Desperately Seeking PCSK9 Eligible Patients

This is one drug that may be more dangerous than all the statins. Although the two drug companies will deny it, it is expected that type 2 diabetes will become more prevalent for those using this drug.

Amgen and Sanofi/Regeneron are expected to rake in many billions (yes, a B), but they need to find the patients who will take the drug. None of the current members of our support group has been contacted or has had the suggestion to consider this drug. I don't think any are considering it, but I could be wrong. Several of us have stated we will not.

To help find these patients, a central strategy of the companies involves giving hundreds of millions of dollars to a whole host of non-profit medical groups, commercial companies, and individual physician experts.

Amgen and Sanofi/Regeneron make the two newly approved cholesterol drugs -- evolocumab (Repatha) and alirocumab (Praluent). These companies are fueling an explosion of new programs, some of which utilize innovative data-mining techniques to gather massive amounts of data from new sources. If these programs work as intended, they will likely identify large numbers of new patients who are candidates for the expensive drugs. How many will be marginal patients remains to be determined, but with money as stake, the numbers will probably be more than expected.

“The sheer size and scope of these programs are not generally known. The activities funded by industry fall across the entire spectrum of basic and clinical research, continuing medical education for physicians, patient education, and support for not-for-profit groups and patient advocacy groups. Of course, the companies are also spending millions of dollars on all the more traditional sales and marketing avenues. The financial tsunami will undoubtedly help secure the close bond between the medical establishment, patients, and industry.”

People with familial hypercholesterolemia (FH) are the best early candidates for the new drugs. The vast majority of people with FH have never been diagnosed, and FH has not been on the radar screen of most physicians. Many of the new initiatives are designed to find these currently hidden patients.

Remember that the long-term clinical benefits with these drugs will not be known for another few years. Also not mentioned are the harmful side effects. These are not complete as of yet and some of them may be severe, especially in the elderly. There could be many problems from overuse of the drugs, the mistaken diagnosis of FH, an inflated perception of risk in some patients, or a lowered threshold for treatment.

There is talk about statin intolerance and once the PCSK9 inhibitors were approved, statin intolerance became a hot topic. Among people in the medical community the manufactured explosion of interest in the statin intolerance is widely known. Most in the medical community do not consider this controversial and it is something everyone knows and talks about, but seldom in public.

“In 2014, Amgen gave money to the American College of Cardiology (ACC) to support a new program called LDL: Address the Risk. An unusual and unique product of the program is the ACC Statin Intolerance App, for iPhone and Android, that "uses clinical guidelines and best practices to help" doctors evaluate, manage, and treat statin intolerance.”

For the new drugs, all you need to do is follow the money. This will show you what is happening in the medical community where everyone is reaching for their unearned share of the largess.

Read the full article here and a commentary by Dr. Malcolm Kendrick here.

Patients, Beware of New Statin Push for PCSK9 Inhibitors

This and the next two blogs are about the newest statins in the PCSK9 class and put on limited use by the FDA.

Amgen and Sanofi/Regeneron, the makers of the two newly approved cholesterol drugs, evolocumab (Repatha) and alirocumab (Praluent), are fueling an explosion of new programs to identify large numbers of new patients who are candidates for the expensive drugs.

An example is a $120 million partnership between Regeneron and Geisinger Health System to broaden the search for genes and drug targets well beyond familial hypercholesterolemia, which is the main indication for PCSK9 inhibitors right now.

By comparing "genetic information against medical histories, Geisinger and Regeneron hope to eventually develop new means of diagnosing, preventing and/or treating medical conditions -- before they cause significant harm. Some participants may also receive information that could be useful in their own medical care."

Peter Berger, MD, who recently became the senior vice president of clinical research at the North Shore-Long Island Jewish Health Care System made comments about the two expensive drugs. Before that, he was at Geisinger, where he was involved in the Regeneron negotiations, though he emphasized that he was not speaking for Geisinger and he was not involved with the final deal. Berger said that at North Shore-LIJ, his main concern is to identify untreated patients who can benefit from treatment, patients who's LDL is way too high on a statin.

Berger then stated, "Most health care institutions, including my own, have too many patients with very high LDLs (for example, greater than 400 mg/dl untreated, or greater than 250 mg/dl on the maximal dose of a potent statin), and do a poor job of screening the family members of such patients."

While it may not matter to the patient what the actual cause of the high LDL is, all the medical people are concerned about at this point is whether they can earn money for getting these patients on the expensive drug. They will bypass any nutritional help and recommend the drug.

“Berger said he reached out to the companies to see if they would help explore the novel use of informatics to help identify such high-risk patients and get them to goal. He said he hopes to establish a program at North Shore-LIJ with industry support to identify such high-risk and insufficiently treated patients. Berger is keenly aware of the potential economic impact of the PCSK9 inhibitors and said that the study he is proposing contains an analysis of the economic impact of the drugs. In fact, he said that the drug companies readily agreed that such an analysis be a part of any study they fund.”

“Berger admitted, he was extremely concerned about the price of drugs in general, including the PCSK9 inhibitors. The pricing of drugs in this country is obscene. In the case of the PCSK9 inhibitors, I hope a third or a fourth PCSK9 inhibitor hits the market and drives the price down."

“But, he said, he's "not concerned at all that by identifying and screening more patients we will be expanding the pool for these drugs," as long as the patients receiving such therapy are appropriately selected." Berger emphasized that all such patients should be counseled about the role of diet and exercise, but did acknowledge, however, that intensive lipid lowering drug therapy is virtually always needed for patients with LDLs in the 400 range.”

All I would add to this is that as long as there is money flowing into his pocket, he will say and advocate for anything.

What a Patient Wish List Should Include

Johns Hopkins Hospital has developed a patient wish list the patients have made on surveys or complaint letters.

The list is not intended to comprehensive, but it is intended to be a conversation starter. The list follows:

1. Let me sleep. Do not take vitals throughout the night or draw blood between 10 p.m. and 6 a.m. unless it is critical. If it is critical, please make sure I understand. My sleep helps me recover and feel better.
2. Keep the noise levels down at the nurses' station. This is so important — especially at night when my sleep is needed. Turn off the TV, radio, computer screen, etc., at night in my room so there is not a glare or noise that can disturb my sleep.
3. Don't lose my personal belongings. Take an inventory and label everything with my name and medical record number so my personal belongings do not get misplaced. These belongings are an extension of me and make me feel more at ease. Taking care of my stuff feels like you are taking care of me.
4. Knock on the door before entering. This shows respect for my privacy and me as an individual. Introduce yourself to me and shake hands or make eye contact when you do this. Call me by my preferred name (formal or first name).
5. Please keep my whiteboard current and up to date. It gives me a quick reference of who is caring for my daily plan and me. Provide a notebook at the bedside so I can keep all my important papers and cards from my health care team and other staff members in one place. Please make sure my name and my location — nursing unit, room number and room phone — are listed on the front.
6. Update my family and me if you notice changes in my condition. Keep communication open. Please keep me informed of delays — it lessens my anxiety during an already stressful time.
7. Keep my room clean. Mop the floors every day, wipe surfaces to prevent the spread of germs, empty my wastebasket and keep my bathroom really clean so it even smells clean. If you are my housekeeper, please introduce yourself to me and say hello. I like to know who is taking care of my surroundings.
8. Listen to me and engage me in my care. Use plain language and make sure I understand my plan of care.
9. Please orient me to my room and the hospital so I know where important things are located, how to work the television, how to order food and when my linens may be changed. I am a guest here and don't know these things, yet these are important to me.
10. Please maintain professionalism in ALL areas of the hospital. While you may be on your break, you are still a hospital employee and a reflection of the hospital. How I perceive you is often how I perceive the hospital and care that I am receiving.

If you have experiences from a hospital stay or from working as a health care professional, that you think should be included, please share via the comments.

Many of the hospital surveys I have seen have nonsensical questions that seldom have anything to do with being in the hospital and the care received. They are all concerned about the room and its cleanliness and maybe a question or two about how fast the call button was answered. I will make comments on future surveys now that I have a guide.