Who Will Pay for Your Fracture?

Most of my patients initially refuse when told that they need to start medication for osteoporosis. Why such an overwhelming negative response? The ads soliciting supposed victims of anti-osteoporosis drugs such as Fosamax, have been so wide spread and convincing that the general population is now convinced that the treatment is worse than the disease.

The high level of fear among woman regarding treatment of osteoporosis worries my colleagues and I. Although it is likely that after many years taking drugs such as Fosamax can cause bones to become brittle, the type of fracture they may contribute to is less than one percent of all fractures related to osteoporosis. Some experts believe that for about every 300 osteoporotic fractures there may be one fracture related to treatment.

How dangerous are fractures related to osteoporosis? The rate of people dying within a year after suffering a hip fracture is almost double and the risk seems to be higher the younger you are when the fracture occurs.

The question in my mind then is, who will compensate woman who fracture due to osteoporosis after being frightened away from treatment by lawsuit ads? When pharmaceutical companies promote a drug treatment they must provide “fair balance” resulting in promotional drug ads which devote most of their time to the negative aspects of the drug. Not so with the “have you been injured by Fosamax?” ads. The scarier the ads the more effective they are, which serves their purpose very well.

I propose that a fund be set up by those broadcasting, “have you been injured” ads to compensate people who have been injured because of their scare tactics. My thought is that many people are hurt by these ads because of their unbalanced and purposefully frightening message. Why shouldn’t there be a way to provide the resources needed to help the victims of such propaganda?

Am I off here, or do you think I’m right?

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

Is it a thyroid or adrenal gland issue?

A while back one of our members, Sylvia, described some troubling new symptoms she was experiencing. A recent contribution to her thread on the message board here at metabolism.com made me re-read Sylvia’s original post. What she described was recent onset of weight gain, depression, high blood pressure and ankle swelling (edema). Her concern was that although her thyroid blood tests were described as “normal”, that the thyroid was the source of her new problems.

On second review the thought occurred to me that the combination of problems Sylvia described is typical of an over-active adrenal gland. This is referred to as Cushing’s Syndrome. With Cushing’s, due to persistently elevated levels of adrenal hormones including cortisol, DHEA, androsteinedione etc., complications develop that include the very ones Sylvia identified; high blood pressure, swelling, weight gain, and depression. Other developments may also include diabetes (high blood sugar), easy bruising, osteoporosis, unusual and severe infections, muscle weakness, and purple stretch marks.

Cushing’s can be diagnosed by obtaining a 24 hour collection of urine for cortisol measurement and by measuring levels of cortisol in the blood in the early morning and late at night. With Cushing’s, urine cortisol levels will be high and there is a loss of the daily high to low transition of blood cortisol levels (diurnal variation).

Sylvia….if you are still reading metabolism.com you should think about the possibility of Cushing’s Syndrome and take it up with your own health care professional. Posting a follow-up of your progress would be very helpful to us all.

Thanks,

Dr. G. Pepper, editor-in-chief, metabolism.com

These comments are for educational purposes only and are not intended as medical treatment. The disclaimer at metabolism.com applies to all comments at this website.

5 Steps to a Healthy Being by Beth Ellen DiLuglio M.S., R.D., C.N.S.D., C.C.N., LD/N,

5 steps, 5 simple steps can help us reduce dis-ease and induce ease.

1)  EAT WHAT GROWS OUT OF THE GROUND.  A pretty simple concept, yet the best way to have a healthy diet high in fiber, antioxidants, phytonutrients, good fats and good carbs.  Eating 5 or more servings of fruits and vegetables combined can reduce your risk of cancer, heart disease,  high blood pressure and even osteoporosis.  Ideally eat 9 or more servings per day for optimal health.  Add whole grains, legumes,  nuts, seeds, herbs and spices and you are on your way to a truly health promoting diet.  Of course it is important to minimize exposure to pesticides and toxins that can end up in our produce and we’ll cover that in a future post.

2)  HYDRATE.  Drinking adequate amounts of fluids is extremely important to our metabolism.  Our bodies are at least 60% water and even mild dehydration can lead to headaches, fatigue and impaired athletic performance.  Preferably our fluid intake will mostly come from purified water (I recommend Reverse Osmosis for several reasons we will cover in a future post).  You can use RO water to make tea, coffee, lemonade and fruit seltzers.  Most of us need at least 1 ounce per kilogram of body weight to start.  We need to take in additional fluid in case of hot weather, losses during exertion, fever and other specific conditions.

3)  BE ACTIVE.  We all know that a sedentary lifestyle can increase our risk of heart disease and even cancer!  Moderate activity that lasts at least 60 minutes should be done daily , or at least 5 days per week.  To improve our fitness level, aerobic activity can be added a minimum of 3 times per week along with some weight training to build and maintain lean body mass.

4)  RELAX.  Stress can be as detrimental as a poor diet.  The “fight or flight” response is great if you have to wrestle a foe or escape from one.  A chronic “fight or flight” response is not great as the hormones coursing through our bloodstream can actually wreak havoc on our systems over time.  A constant barrage of cortisol can even negatively affect parts of the brain.  Deep breathing can reverse the stress response and begin to restore balance and harmony.  Plan play time and get adequate sleep in order to keep that balance.

5)  SMILE!  Just the thought of a smile can make us feel really good.  Imagine what the real thing can do!

What is the Correct Vitamin D Dosage?

Annette posts a question to metabolism.com since she is on a high dosage of vitamin D due to intestinal surgery. Is the dosage too much for her, she wonders?

When the intestines fail to absorb fats due to surgery or due to disease, Vitamin D which is a fat soluble vitamin, can see its levels fall dramatically. Otherwise healthy people in the U.S., however, are being found to have unacceptably low Vitamin D levels. Is it due to inadequate diet or is it a result of wide spread sunlight phobia?

Here is Annette’s post followed by my response to her question. Answers to these questions are contained in this exchange.

Annette writes:

I had a Bilio Pancreatic Diversion surgery done in 1990. My Vitamin D level is low, at 15.
My Dr. has me on 50,000 iu of Vit D every other day, 4,000 iu on the other days.

May I ask you, what is your opinion on this amount of Vit. D. The 50,000 iu capsules are by prescription.

Thanks so Much,

AS
**************************************************

Metabolism.com responds:

Vitamin D deficiency is a serious problem and has been largely overlooked in the general population until recently. Vitamin D is not only important for bone health but we are learning it is important for the immune system and may help protect against certain cancers. In my medical practice in Florida I am finding an alarming number of my patients with very low and borderline low levels of Vitamin D that were totally unexpected. I assume it is because everyone knows that sunlight is bad because it causes wrinkles and skin cancer. The further north you live the weaker the sunlight so the incidence of vitamin D deficiency is higher.

Until recently the recommended daily Vitamin D allowance was 400 IU but recently this was increased to 800 IU and some authorities recommend higher amounts.
10,000 IU levels daily for the average normal person is thought to be an upper limit before toxicity can be seen. Vitamin D is a fat soluble vitamin so in people who have problems absorbing fat, such in your case after intestinal bypass surgery, higher amounts are needed. Vitamin D doses of 50,000 IU at a time are not unusual but are usually given only a few times weekly or monthly, depending on needs. A handy tip is that deficient Vitamin D causes serum calcium levels to be low, so many clinicians will monitor serum calcium levels to help adjust the prescription.

Although I can’t recommend medical therapy in this forum I have some thoughts I can share. Why not get another blood vitamin D level measured to see if the amount you are getting is okay? Calcium levels go up in vitamin D excess so a serum calcium level that is elevated can be an indication of too much vitamin D.

Hope that helps. Keep us posted.

The metabolism.com website disclaimer applies to this and all my posts.

G. Pepper

Mele is Out of Armour and Out of Options

Below, Mele describes her plight struggling to adjust to the disappearance of Armour from U.S. pharmacies. She discovered what was explained in my post, “Behind the Disappearance of Armour”. Forest Pharmaceuticals and Medicare are both responding in their own ways to the FDA decree that Armour Thyroid submit an application (NDA) as if it were any new drug seeking to come to market now. The FDA is charged with the responsibility to assure all prescription drugs in the U.S. demonstrate minimum levels of safety and efficacy. As a bureaucracy the FDA is unable (unwilling) to find a way to use the 50+ years of unblemished clinical experience unique to Armour, to satisfy this requirement. Rather than correct its own deficiency the FDA is forcing many thousands of hypothyroid patients on dessicated thyroid products to go through the difficult and potentially dangerous process of finding alternative thyroid hormone therapies. I am guessing that the FDA is receiving support for this policy from companies making synthetic t4 products and from medical organizations and their officers who receive funds from these same companies. Let’s not forget that Forest itself markets a generic t4 product, Levothroid, which will absorb some of the business lost by the withdrawal of Armour.

Mele submits her story to metabolism.com:

I’m just devastated. I could only get a seven day supply yesterday of Armour at Wal-Mart. They have no idea what the problem is and told me to come in Tuesday and they would have some again. I had no idea there was a problem again (last year’s nightmare made me assume everything would be ok after Forrest redid their manufacturinging plant) until I googled today.

I am 66 years old and have been on Armour Thyroid since I was 15 years old when I had a subtotal thyroidectomy for carcinoma. The only time I ever tried Synthroid was about 20 years ago when an endocrinologist convinced me that I was going to get osteoporosis if I continued using Armour. I only took it for two months, and when I walked into my family doctor’s office at the end of the two months, he took haveone look me and said “whWt is wrong? You are not you”. I wasn’t me anymore (and the blood tests he ordered confirmed that I was very low on T3 and barely in the normal range for T4). That was probably the most terrifying experience I have ever had. I had no idea how totally entwined my personality, and feelings of well being, are dependent on Armour. I still find it scary that “me” is a product of a drug I take and when I take a different brand, I am no longer me. I felt like a stranger in my own skin…weak, no sparkly, dramatic personality… instead dull feeling, acting and cobwebs in my brain. My family doctor said that he was putting me back on Armour immediately and slowly I began to feel like me again.

I’m terrified now. I am in the middle of trying to prepare for a very complicated (nothing is ever simple or easy medically for me) cataract surgery in another city that I have fly to repeatedly for the presurgical appointments. If I have to go on Synthyroid again…how can I deal with this other upcoming surgery? It can’t be put off as I can barely see to drive now.

Anyhow, I agree with others here that we have to organize and fight this. I find it very difficult to believe this is simply a shortage of the thyroid powder that Forrest is claiming is the problem. This is the FDA meddling, yet again, with patients very lives. I think I know an organization that will help us as they have fought bloody battles with the FDA for many years and have been victorious to a large extent. I am speaking of the Life Extension Foundation. I’ll be contacting them.

Two other things. For what it is worth, I have noticed no problems with the change in Armour but for the first time in many years, I have not done thyroid blood levels in two years. But I feel fine so I guess I don’t have the absorbtion problem some mention with the new formula. I have had hair breakage though which I have puzzled over and that could well be due to the formula change.

As for Medicare and Armour, I have had Medicare since a drunk driver hit me many years ago so I have had Medicare long before I turned 65. When Medicare Part D first appeared Armour was on the Medicare forumulary. That was in mid 2006. Armour was on the Medicare formulary in 2007 also. Beginning Jan 2008, Armour was removed from the Medicare formulary. My physician I did a lot of research, calling, letter writing, etc. about it. My drug plan was and still is from AARP/United Health Care. United Health Care is angry about the Armour situation. However, they cannot make a special exception to cover it when a physician asks them to do so (as mine did) because their hands are tied. They are required by law to allow ONLY drugs that are approved and on the Medicare formulary.

AARP/United Health Care covers ALL drugs on the Medicare formulary and by law cannot cover any that are banned from the Medicare formulary. Armour was banned in 2008. I called Forest about it and was extremely puzzled by their lacksidasical response. My physician wrote Forrest also and they sent back a reply that had nothing to do with the question about Armour being removed from the Medicare formulary. My physician learned later that his, and my, suspicions were correct. It was removed because the FDA told Medicare that they could not cover a drug that had not gone through the NDA I believe it is called…where a new drug has to undergo extensive clinical trials as per FDA regulations. We learned that the FDA was requiring Forrest to do this if they wanted Medicare coverage for Armour. Well, that is not possible. Forrest charges very little for Armour. Where are they supposed to get the money for the many years of clinical trials that the FDA has demanded? The FDA knew that demanding this would effectively kill Armour and that was their intent.

So, since Jan 2008, I have had to pay for a Medicare Part D plan that I can’t use because the only drug I take (unless I need an antibiotic or something short term) is Armour. Wat is worse, most health insurance companies follow the Medicare formulary so if Medicare no longer covers Armour then most insurance plans will not cover it either.

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