Cholesterol Lowering Drugs

   To my knowledge, there is little evidence to support broad use of statins - or medicines that lower cholesterol.  The goal for treating high cholesterol is to decrease risk of heart attack and early death.  The research I have reviewed only showed this benefit for statin users who have been diagnosed with heart disease or who have had a heart attack.  It is that group that benefits from use. The new recommendations are to give statin medications based on factors (like having diabetes) other than a persons blood cholesterol level.  In a way, this removes the argument of how high the LDL level has to be before medicine is prescribed and at what dose should the statin be started, based on that LDL number.  The cut off number was always arbitrary.  How could there be more risk at 120 and not 119, for example.  But I don't know that this is any better, because it still places an emphasis on pills over lifestyle.
   I share the concerns of CNNs Dr. Sanjay Gupta who equates this shift to medication over changes in diet (and exercise) as a sign of defeat against the prevention of diseases associated with obesity.  Medication is not the solution here and we shouldn't give up on prevention.
    I understand that efforts to nudge people into better lifestyles has not been successful.  I don't think encouraging people to rely on medicine to fix problems is better than changing the environment to provide people better options (i.e.,  options to be physically active and to eat in moderation).  It does seem that nutrition information and nutrition guidelines are consistently and broadly misunderstood by a majority of persons.  This is in large part due to the complicated and ever changing information out there.  It is confusing and most people don't know what to look for when assessing a food's nutritional content and 'healthiness.'
    Just recently, I walked by a man and woman at the grocery store as the man was reading the back of package nutrition label.  (YAY!)  I heard him say, "Oh no, this is loaded with carbohydrates."  I wanted to stop, go back and ask him,"And what exactly does that mean to you?  Why is that a good or bad thing?"   Because if all someone told me was "its loaded in carbohydrates," I could not make an informed decision.  Sugar is a carbohydrate, so are vegetables and grains!  
   Our education and health promotion efforts must be constant, but simplified. Americans consume diets that are high in calories and items that might lead to high cholesterol, diabetes, obesity, heart disease, etc.  The main objective to improve health should be changing the diet (and increasing activity) not medicating the entire country.  Using medication in this way is as foolish as providing more rescue workers to collect the drowning from the river instead of putting a rail on the bridge to keep people from falling in the river.

One (good) disease leads to another

Not at all a good disease, just a play on words. I am speaking about Parkinson's Disease today as a popular press headline caught my attention. The news story got much of the study correct, except that is states the research as "confirming" a link between Parkinson's and Melanoma. In fact, the study supports the link, and it supports previous research, but in the actual journal submission, the researchers do make a note about caution when interpreting the results which implies anything but a confirmation. The warning has to do with the data that was reviewed in that it wasn't all collected in the same manner.

Still, let me share a few things in case you are unawares. Parkinson's Disease is often associated with tremors and gait disturbance and is more complicated than a similar condition called essential tremor (ET is a progressive neurological disorder as well). Parkinson's is chronic and does worsen over time, i.e is progressive, but it is also degenerative in that the symptoms become disabling. In PD the patient may also have problems with thinking and speech.

Parkinson's disease does not have a definitive cause and is often considered idiopathic - meaning there is not clear cause! It does involve a lack of the neurotransmitter dopamine - it just isn't known exactly why the cells that produce dopamine die off in these persons. The most common treatment is with a drug called levodopa which the body turns into dopamine. Dopamine helps with movement, thinking, emotions and feelings of pleasure.

For some time, there has been concern about a higher than normal incidence of the most serious skin cancer, melanoma , in patients with PD. (other skin cancer types are basal cell and squamous cell) There has been previous research of the issue with two theories. One is that for some reasons PD patients are just more prone to it (making me think maybe dopamine is a protective factor?) or the medicine to treat it was itself putting the patient at risk.

The study from the University of Nebraska Medical Center found the four fold increase of melanoma with PD persons as compared to similar non PD persons and did not think it was from levodopa. I found a better report in a medical magazine and will link it here.

However, in educating myself about this condition and seeing that the levodopa was considered suspect at some point, I want to use that as a teaching point. If you find yourself needing a prescription medication and it has one of those warnings about avoiding sunlight - you might want to take that a little more seriously.

Misleading Ads

I have to tell you that the impetus for this post is an article that you can read yourself at Forbes.com which includes the photo ads of ten separate drugs whose makers received warning letters from the FDA in 2009-2010. I will also link you to the FDA website where you can see advertising warning letters. They are sorted by company not by drug.

The Forbes article addresses the issue of direct to consumer advertising which is, in my opinion, only harmful. There were news stories last year about this same issue and that the companies were getting warnings because they are at times over emphasizing benefits, and almost always, minimizing side effects. The Forbes article points out even more blatant examples of this. Funny thing was that they started off talking about the advertisement for an eyelash thickener that Brooke Shields presents. The company,Allergan, got a warning because they were not clear about the side effects of use. I thought, "what?" every time I hear that commercial I cringe and wonder who in the world would take that kind of risk. Alas, the company CHANGED the ad after getting into trouble last year and I am hearing the new one.

The real thing to do, (I know it is a pain), if you want to take a medication because you believe you have the condition advertised then go to the FDA website and get the real story and the whole story. Do not rely on your physician to have done this. Unfortunately, the physician is often getting the same false or misleading information that you are and from the same source, the drug company.

But even so, if you are intrigued by an ad, pay attention to it. I told you before that the Nutrisystem D commercial got my dander up and was misleading in that it says based on years of clinical science and such, but does NOT say that it is clinically proven to work. There is a big difference. But it gets better. I caught some more of the advertisement recently (they play it ALL morning on CNBC for some reason), it says that the people on the Nutri System D program for X amount of weeks lost 16 times more weight and had blood sugars 5 times lower and an A1C a point or so lower than - are you ready? " than people who attended a diabetes education and support group." SO, people who went on a diet lost more weight than people who did not! And the people who lost weight had lower blood sugars.... Well, my friends, I would bet my last dollar that the changes in weight and blood sugar had everything to do with calorie control and if I matched a group with the same calories and REAL food, the results would be the same.... (also they never say how many people, two?, ten? 100?)

Save your money or better yet, spend it at weight watchers.........
(or watch my videos on You Tube and cook the Volumetrics way)

but I digress - here are the links I promised

http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety.html

http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?office=Division%20of%20Drug%20Marketing,%20Advertising,%20and%20Communications

Depression

I am not exactly going to blog about depression. In a bit of irony however, a research study was published in JAMA regarding the effectiveness of a few psychotropic medications I mentioned in my blog about anxiety yesterday. With the Penn State study and a previous study from the University of Hull (UK), comes more evidence that these drugs, at least in the treatment of depression, are not a panacea and may not even be a temporary fix.

Several schools and several researchers were involved in both studies. They
evaluated existing clinical trials, some which weren't published but made available through the freedom of information act, and they LOOKED BEYOND THE HEADLINES... In some cases of severe depression, which was not defined, but from my experience would include persons with nihilistic delusions, severe apathy, extreme weight loss or gain and inability to function - there was some effect, with some of the drugs, some of the time. BTW, electroconvulsive therapy also works!

Instead, most studies show that there was no difference between the drug and a placebo. With the great risk associated with these drugs, mostly weight gain and then diabetes, that should be a treatment changing finding. This is the type of research we need. Billions of dollars are spent on these drugs - Paxil, Prozac, Zoloft, Effexor and more.

One drug company that responded to the study said that the design of their studies and the university studies were not the same so they really weren't going to comment beyond noting that their medications had improved the quality of life for many people who take them.

Drug companies say that they are not creating the drugs for people with mild to moderate depression, but you sure wouldn't think that from watching their ads. If anything, they seem driven to convince us all that we have clinical depression and their pill could eradicate it in a day. Truth be told, even when drugs are deemed effective, it is after several weeks of taking them.

Two things in the Forbes article by R. Langreth are worth repeating. One clinician advised that alternatives to medicine should be considered and that includes exercise and talk therapy - I am sure that some of the strategies for managing stress in yesterday's post would also be helpful.
Another scientist noted that the idea that drugs that keep serotonin (a mood stabilizing neurotransmitter) available in the brain (uptake inhibitors) really were not effective and that the idea that a lack of serotonin leading to depression is a MYTH! I think they should concentrate on endorphins and dopamine which is probably why so many studies do show that exercise is at least as effective as drugs in treating this condition and a helluva lot safer.

I will share a personal story with you now. It is something that happened to me at least a hundred years ago, or maybe ten...

I was having a bad time and went for some counseling. This was after my first round of college but before my graduate work, etc. I saw the counselor a few times and then one day she said, "I spoke with your insurance company and they think the best thing to do, the thing that will work the fastest, is to put you on medication - an antidepressant." I cannot in words express to you how angry I became. I certainly used very bad language. I could not believe that I had come in to get a sense of direction, do a little brainstorming and goal planning and was told that I had clinical depression and needed pills. I told her that I would not take medicine, I was not depressed, but had issues with the way my life was going - or the path I was on. I was unhappy, yes, but I was going through a crisis. She did say, something like wow, that is the first real emotion you've shown since we started. WHATEVER! :) But you know, this was a turning point to me and what I said to her then is very important for all of us.

I was going through a crisis. And contrary to what Big Pharma wants you to believe, life stresses and even significant crisis do NOT require medication and even if they did, the ones out there do NOT work. I am not talking clinical and severe depression and please, never abruptly (or without telling your doc) stop a medication that you have been prescribed, but also know that sometimes the only way out of something is through it - you have to take one step at a time and get through it. Exercise and writing or talking things out - that'll help.

mGy

Hold on, I will get to that....

While commenting on different issues over the years, I have mentioned my concern for the amount of radiation that our bodies are exposed to when having medical exams or diagnostic tests, including CTs, X-rays and X-rays at the dentist.

I may have mentioned that in recent years, I have become more assertive in assessing the situation and even refusing to have X-rays from time to time. I am a definite opponent to CT scans used as screening measures for lung cancer in smokers. How counter intuitive is that?? If you want to reduce the risk of lung cancer, tell the patient to QUIT smoking....for example. But I also don't think we should have our bodies scanned every time something hurts.

So when I received an FDA e mail alert on radiation overdoses, I took the time to read the text. It seems that a large group of people, 200, were exposed to enough radiation in a brain scan to have their hair fall out and their skin break out into a rash. This occurred at one facility and with one machine, but the FDA alert notes that the situation was uncovered because the patients had symptoms. It is not out of the question that other machines are also over radiating people but more subtlety and that over time that radiation will lead to conditions, such as cancer.

The agency is urging facilities to monitor the control panels of their machines which list the dose indices. The two things that the operators should note are the volume CT dose and the dose-length product. These are measured in milligrays and milligray-centimeters, or mGy and mGy-cm. The FDA does not say what the indices should read, only that the facility should check to make sure that the numbers are similar to those that would normally be used for that particular diagnostic test. [that scares me, is there a universal scale?? who decides? - why don't they already do this?]

The FDA suggests that the indices be checked before AND after the scan. I think that if I ever am in a position that I really need a CT, I am going to mention this study.

I know that not everyone who needs to see these FDA alerts, which I voluntarily signed up for, sees them. Back in the summer there was an email about a product that was being used to topically treat inflammation which was not FDA approved for use. My physical therapist's office HAD THE PRODUCT for sale and even after I told them about this, and they went on line to find the information, they kept it on the counter....

Sadly, no one cares about your well being more than you do and sadder still, some times "you" don't care either....

Samples that Shouldn't Be

My post for this Saturday evening or Sunday morning will be brief. I am disillusioned once again, though I should not be because I KNOW, that is why I write the blog, so that I can let YOU know…

I am signed up for regular prescription, medical device and other such warnings from the FDA. Most of the medicines or equipment that I receive alerts on do not effect a significant part of the population and rarely do they directly effect me (not since Vioxx!).

I receive notices in my email when an existing medicine receives a black box warning or a label change and when a medicine is contaminated. Recently I have received some alerts about IV tubes and diabetic strips that were irregular. And most recently I received a notice about several products that were being marketed and sold illegally. I read the alert and therefore my brain stored it somewhere, but I did not expect it to matter to me and I did not say anything to you guys.

The alert was regarding various companies that are selling topical ointments, sprays or creams that have ibuprofen in them. They may also have other ingredients, like herbal or supplement products. The companies are getting letters from the FDA because ibuprofen is a medicine. One cannot just add it to things and sell it and not have FDA approval for safety and efficacy.

I read it and moved on. Then on Wednesday of this week, my physical therapist suggested that I take some of this sample medicine home, Ibunex was the name. She gave me two samples and a brochure. I read the brochure and I said to her, this is ringing some kind of bell in my head. I thought at first that it was undeclared ingredients or something. I came home and re read the alert and this was exactly one of the products that was being recalled. The physical therapy office had a sign up offering two free samples if you bought a bottle of the spray.

So just like drug companies, these lesser companies sway health care professionals including mine, and my health care professionals were likely selling the medicine/supplement to make a profit. I emailed the alert to them the next day. If the product is still on the counter Monday, we will have an issue.

BTW, the PT office also had a sassy chair or whatever you call those godforsaken motorized scooters in the lobby with a big sign on it regarding how they could help you buy one.. just so disillusioned am I.

Black Box Warnings

What exactly is a black box warning, when does it matter and what drugs have them? I hope to answer those questions today.


A black box warning is the FDA's strictest warning for a prescription medication. It is on the label or package insert of a drug which may have a high risk of a fatal side effect, like a heart attack or a non fatal but disabling side effect like bone loss or tendon ruptures.

Sometimes a black box warning is recommended by a panel but not adopted by the FDA.

Many drugs have black box warnings, here is a link to a list.


http://www.formularyproductions.com/master/showpage.php?dir=blackbox&whichpage=9

The warning is meant especially to alert physicians so that the medication will only be prescribed in exceptional circumstances and or to people who are not susceptible to the specific risk. Generally speaking, it is not believed that the warnings are effective.You might wonder why a drug that has a risk of a serious side effect is available to you at all and so do I, but there are justifiable reasons.

At times the serious side effect only applies to a certain group of people. For instance, and if memory serves me correctly, Vioxx had a very strong warning, if not a black box warning, about heart attack in people who had high blood pressure. If you did not have high blood pressure than Vioxx did not expose YOU to that risk. Except, they were wrong, it exposed everyone to increased risk for heart attack and that is why the drug was pulled off the market.
Even if Black Box warnings are meant for physicians you must be an informed consumer. You MUST be an informed consumer. Doctors are people too and they make mistakes and they fall prey to pharmaceutical persuasion and sometimes they don't know the latest info on a drug. Better you ask the pharmacist. Better still that you read the medication guide. Actually, I suggest you read the medication guide before you even fill the prescription. Medication guides can be found here: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm

So when would you choose to take a drug with this warning? I am going to suggest that you do so as a last resort or if you are not in the target group for the adverse event risk. I personally, ALWAYS chose medications as a last resort. One of the reasons I offer for that is post marketing drug analysis. Many times, the minor side effects found in a drug study, or major effects found in a few people, significantly increase when the drug is made available to the general population. There are many instances of where drugs are pulled some seven to ten years after they were introduced, because the risks did end up to be too high. http://www.bmj.com/cgi/content/full/318/7188/944/a

http://www.bmj.com/cgi/content/abstract/294/6568/355

Questions to consider? Is this the ONLY treatment for my problem? Maybe it is cheapest or quickest, but that doesn't mean safest. Maybe a safer drug will have a 80 percent cure rate and the drug with the risk of heart attack has a 90% cure rate, but that ten percent extra chance of improvement won't matter if you are dead.


I can say that when I had those horrible migraines a few months ago, I felt, truly, that the risk of any side effect was worth the chance that the headache would go away. I recall lying in bed and thinking, "this drug may kill me" and then thinking, "I don't care." That was a very very bad week of head aches as I am NOT looking forward to death. So I think that is one of the times you take a risk.



Not in all situations, but certainly many, I agree with the following statement:

"The point to all of this is simple. Make the black-box warnings irrelevant by changing your lifestyle so you won't ever have symptoms that drugs would be needed for."

Joseph Mercola, D.O.



Of course, Dr. Mercola seems a man after my own heart, except that I realize that there is a time and a place for medication and when that is the best option it SHOULD be utilized.



Be Well.

Weekly Wellness

Alzheimer’s Nursing Homes and Psychotropcis: There has been some press regarding off label use of anti psychotic medications in the elderly, especially older persons with Alzheimer’s disease. AD is a progressive, debilitating, brain illness. Basically the brain degenerates. Tissue actually dies and on a SPEC or PET scan one can see black spaces where brain matter should be. For whatever reason, some patients with dementia have significant behavioral problems. [Well, it actually makes sense in the same way that people who have brain trauma and lose brain matter often act out]. Sometimes in the AD cases, the behavior is related to an acute illness, like a delirium. Many times persons not familiar with geriatrics mistake these acute symptoms for a progression of the Alzheimer’s or even a chronic Alzheimer’s feature. There are actually so many things that can be happening which do lead Assisted Living Facilities or Nursing Homes to bring these residents to the ER. I say all this because I was one of the people on a multidisciplinary psychiatry in patient team who sought to stabilize these people. Our role was to manage their symptoms and return them to long term care. It was often a fight to return them to the SAME facility. It is absolutely not as simple as some consumer groups would have us think. I whole heartedly agree that zyprexa, risperdal, haldol, abilify and the like should NOT be used. I argue that acute illness be ruled out first, upon examination, i.e. bowel and bladder disturbance, renal disease, and blood sugar extremes. Just because an 80 year old has a diagnosis of dementia does not mean they don’t have a urinary tract infection. I fully support efforts to change the environment in the facilities as well. Add staff to redirect wandering, excitable, confused and scared persons. Yes, more staff. Another problem is that hospitals and facilities are scared to death of falls and thus a medicated person who won’t get up is a lot better on so many levels than a frail walking un medicated one. But I digress. That kind of hands on, low resident to staff ratio seldom occurs, in doesn’t occur in Medicare Medicaid facilities. In the hospital, physicians are pressured to get the patient out as soon as possible and the long term care facilities won’t take an aggressive restless person back so the only solution is overmedication. Family members often agree to the meds because they have no other choice for “placement” as they call it. Thus now you know, it is NOT that simple. What is simple is this. Dementia is NOT a normal part of aging.

Fish – Fish OIL: Ironically, the health benefits associated with the Omega 3s in fish include heart and brain health. The question is yet unanswered as to if the fish oil capsules are as protective as the fish itself. A recent study still leaves room for doubt. It is very important again that one read beyond the headline. The study involved a small group, two groups, of women. Less than 30 people total and that is too small to allow for any type of population generalization. Any way. One group took capsules while the other got the same mg of Omega 3s in actual fish. Afterwards both groups had the same blood level concentration of Omega 3s. That does not answer the question, “ Is the effect the same?” A long term study would be needed for that and frankly; you don’t have time to wait for that. Eat your fish. They contain additional elements, protein, minerals, and yeah, well ok, a little mercury, cadmium…….. Oops.

SWEET! Oh I like this study from a place called Kaleida Health in Buffalo NY. Actually more than one study and the results are also more suggestive than causal. Oxidative stress and inflammation occur often in our bodies. Bad things like smoking cause it. But good things like exercise also cause it as do necessary things like eating. There appears to be an inflammation process to all cellular activity and free radical release. The accumulation of free radicals is quite harmful and inflammation in the blood (c reactive protein, homocystiene) can be a marker of heart disease. We also have a built in clean up effect, the antioxidant process which can be enhanced when we eat foods like blue berries and fruits and vegetables. Obese persons generally have more inflammation and high fat foods themselves increase oxidative stress, acutely. A healthy, active person of normal weight may still have an oxidative response when they eat, but it abates quickly. The researchers found that normal vs. obese subjects who ate the same high fat high calorie (1800) meal [meal? That is what I eat in a DAY] had the same spike but it lasted much longer in the obese group. That will increase their already higher risk of heart disease, and heart attack. However, there was also a study in which the same 1800 calories was in high fruit and high fiber and there was NO SPIKE. I don’t recall if that included both normal and overweight persons.

Radiation: It has been said that X-rays should not be used with reckless abandon as radiation exposure can change cells and damage DNA which is one way cancer can initiate. Now there is a concern about warning people who have been given radiopharmaceuticals. This would be chemotherapy as well as perhaps dyes used in bone scans. Apparently it leaves the patient a little radioactive themselves. Enough so that days and months later the person will set off an alarm at the airport. Doctors are being asked to warn persons of this possibility. Geez.