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December 31, 2013 at 10:37 AMComments: 0 Faves: 0

The New Cholesterol Guidelines: What You Should Know Part 2

By Dr. Jeff Chamberlain, MD More Blogs by This Author

This is part 2 in a series I am writing on the new cholesterol guidelines recently published by the American College of Cardiology (ACC) and the American Heart Association (AHA). If you have not read the first blog yet, I recommend you do so.

This blog will not sound like I'm talking about cholesterol guidelines and heart attack prevention at first, but once I have circled around to it, you will see why this  is an important addition to the heart attack prevention conversation.

When you are treating a medical illness, be it with medicine, a natural product, or other methods, I want you to think if you are taking it to treat symptoms or prevent disease. If you are taking something to prevent disease, it is good to find out if your treatment is simply treating a risk factor, or if it has been proven to prevent the disease.

When treating patients, I mentally split medical conditions into two different categories:

Conditions where the symptoms are the "problem," and are what is being treated. 

Good Examples Include: Symptoms from viral respiratory illnesses such as coughs, sinus congestion, nausea, diarrhea. Depression and anxiety, pain, and ADHD.

What Makes a Symptom-Based Condition: In these conditions, if the symptoms were not present, then we really would not care very much about the illness itself. When we have a viral respiratory illness, the cough and congestion are what bother us. Likewise, with ADHD, if there were not the symptoms of hyperactivity and inattention, then it would not cause problems.

Treatment: One benefit of treating conditions that are symptom-based is that we can treat by trial and error. We know that everyone is different, so it is a matter of finding out what treatment works best for that individual patient. Individualized therapy can maximize the benefits for a specific patient. With this approach, we need to keep in mind that illnesses naturally wax and wane. Therefore, if we start a treatment and a patient gets better, it is difficult to know if it is from the treatment, or just good timing. 

Misdiagnosis: In order to avoid making a false conclusion, we need to look for patterns to see if treatment is consistently better. We also use medical knowledge and ask ourselves: "Based on knowledge of the disease process and the physiology of the treatment strategy, is this treatment logical?" Researchers also run studies on large groups of people to see if some benefit from the treatment.

Placebo Effect: A good example of false conclusions is the use of antibiotics for viral sinusitis or viral bronchitis. There are tons of people who swear that antibiotics help their sinusitis or bronchitis. After running placebo controlled clinical trials, it turns out that unless symptoms have been going on for over 10 days, there is almost no chance that antibiotics are helpful for bronchitis or sinusitis. Why is it that so many people are confident antibiotics work for them? It is because they have started antibiotics and then they got better. They have experienced a direct correlation, and our brains are designed to search for, and lock onto, apparent cause and effect correlations. Interestingly, studies on colds and coughs have shown that the majority of people seek medical care within 24 hours of when their viral symptoms are naturally at their worst. This being the case, no matter what treatment we use, within 24 hours of seeking care our symptoms usually will start to improve. 

Conditions where there are not symptoms, but we are providing treatment to prevent something bad from occurring. 

Good Examples Include: Preventing heart attacks. Caring for broken bones. Preventing strokes and cancer treatment.

What Makes a Non-Symptom-Based Conditions: With these conditions, by the time you have symptoms, it is too late. The goal is to develop prevention strategies before the disease occurs. With these conditions, we can not use trial and error for an individual patient. So, what do we do?

Treatment: One thing we do is figure out risk factors for the developing problem and then try to reduce said factors as much as we can. A lot of people don't realize that high cholesterol and hypertension are not really diseases, but are risk factors for developing diseases. If you think about it, why do I care that my blood pressure is high? I care because high blood pressure over time has been shown to contribute to heart attacks, strokes, and kidney failure.

Research: Because it is impossible to directly measure what interventions will prevent any one individual from having a heart attack, we need to look at the data and try to figure out what interventions work well and which do not. Because research can be expensive and timely, it is usually done in stages. These stages tend to look something like this:

  • Stage 1: Observational Research: In these studies, information is gathered about the people taking part in them. These peopel are then followed over time to see what type of health outcomes happen. Over time, risk factors and potential treatment strategies can be identified.
  • Stage 2: Basic "Bench" Research: This is research done in a lab, on an animal. It is done to try to figure of how our body, or disease processes, work. This gives us insight into what approaches, or drugs, may work.
  • Stage 3: Small Scale Safety Trials: Once a treatment seems like it should be safe, based on animal testing, research is done on people in small numbers to make sure the research seems safe. Usually, these trials are "pharmacological" and are used to figure out what type of dosing seems appropriate.
  • Stage 4: Medium Scale Trials: It is important to note that these trials are usually looking at reducing risk factors. They are not looking at end points we actually care about (Does it reduce the chances of having a heart attack? Does it reduce the chances of dying?). These studies continue to gather data on safety. A lot of blood pressure and cholesterol medications are approved after these trials. If they are proven to lower cholesterol or blood pressure, and seem safe, that is good enough, even if there is no proven reduction in heart attack risk.
  • Stage 5: Large scale trials: These trials are very expensive and take years to conduct. Typically, once drug companies have their product to market, and if it is selling well, they do not have very much motivation to conduct a study that may not give them a favorable outcome. If you were making billions selling a blockbuster blood pressure medication that did an awesome job lowering blood pressure, would you want to spend tens of millions of dollars to run an 8 year study, potentially running the risk of losing market share if the product failed? Or would you just keep selling your product?

Why doesn't the FDA wait until the final large scale studies before they approve a drug?

The main reason why drugs are approved before the large scale studies are performed is because of time constraints. If there is a medication that seems like it can help a lot of people, and it has been shown to improve risk factors, then it is approved to speed up time to market. Some people think that this is a hasty approach, while others worry that waiting for approval would hold back potentially life-saving medication.

Even with the final, large-scale trials it is important to remember that the final results tell us what medications have the potential to be helpful over a large population, but they do not tell us specifically if a treatment is going to help any one individual. 

Stay Healthy,
Dr. Jeff M.D.

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