Clinical Trials and Scientific Articles: Read and Believe with Caution

A disclaimer should accompany every scientific article, “Read and Believe with Caution”. To say that weekly there is a study contradicting a prior clinical trial is probably an underestimation of the state of medical/scientific affairs. Hundreds of peer-reviewed journals now cross our desks and computer screens. How do we, the doctors and scientists, assimilate all these data? This is particularly difficult when one considers the complexity of statistical analyses that must be thrashed through in order to do justice to any single study. And then one must remember that we do not have every hour of every waking day to analyze trials. The result is far too often a leap to erroneous but easy conclusions. We saw this recently with a JAMA meta-analysis regarding fish oils (see the blog of my letter to JAMA) wherein standard statistical analysis was plainly deviated from. The result, an unfounded conclusion that no one on TV every mentioned. Perhaps they did not have the preparatory time necessary to dissect the statistics. Whatever the case, medical and lay opinions were unfairly and wrongly influenced by this trial.

And now we have another interesting study, this time in favor of supplements. On October 17th JAMA published on-line the results of a multivitamin analysis of Harvard’s famed Physicians’ Health Study. This trial revealed that simple (low dose) multivitamins could decrease cancer rates in men. Prior studies using high dose supplements have failed to demonstrate this. At the risk of being self-serving, over ten years ago I performed a small clinical trial (published in JANA – the Journal of the American Nutraceutical Association) demonstrating the possible downside of high-dose supplements. I responded to my own trial by forming a very conservative supplement company, VitalRemedyMD.  And my first products were two simple daily multiples with no more than 100% of the RDV of the essential vitamins and minerals (the Daily2Tab and DailyMultiple – innovative names, I know). No more than that. I based these formulations more upon my review of basic science literature, than our too-highly-revered RCT (Randomized Clinical Trials). A decade later, the clinical trial is “catching up” with something that science had already taught us. My point here is that we in the medical world have shunned our roots, basic science. And, we have cut ourselves off from our mentors, the basic scientists. In fact, just last week an article I wrote on this subject that was published online – A Survey of Internists and Cardiologists: Are Discoveries in Fatty Acids Truly being translated into Clinical Practice? Prostaglandins, Leukotrienes and Essential Fatty Acids (available online 25 October 2012). It tells this story. There is a disconnect between science and medicine. It is real, prevalent, and very disturbing. It undermines our ability to grow and limits our capacity to cure. The only way I see we can conquer this impediment is by opening a continual and non-confrontational dialogue among the diverse elements of science and medicine. Only then can we have true translational medicine, the application of what is learned in the lab to the patient in our offices or hospital wards. Short of dialogue we will continue to exist in a modern tower of babble, and we all know how well that worked out.

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10 Heart Friendly Fall Fruits and Vegetables

farmer's market

Fall is a great time to visit your local farmer’s market or vegetable stand. The fall harvest offers a wide range of colorful, tasty and nutritious food choices. Rich orange, green and yellow fruits and vegetables make fall a time of abundant flavors and rich vibrant colors.

Colorful fruits and vegetables contain vitamins, minerals, fiber and phytochemicals that can provide a variety of disease-fighting benefits. A diet rich in fresh fruits and vegetables can help reduce the risk of many conditions, including cardiovascular disease. The American Heart Association recommends at least 4-5 servings per day of fruits and vegetables based on a 2000-calorie diet as part of a healthful lifestyle that can lower your risk for these diseases.

Remember it’s always important to include a wide variety of fruits and vegetables in your diet. Here are 10 healthful fruits and vegetables available in the fall:

  1. Apples – high in vitamin C and fiber – they also contain potassium, iron and calcium.
  2. Avocados – contain high quantities of vitamins A, C and E.
  3. Beets – a great source of folate, vitamin C and potassium.
  4. Brussel sprouts – vitamins C, E, B-6, A and K, folate, lutein and choline and the essential minerals calcium, iron, phosphorus, magnesium, potassium and selenium.
  5. Cabbage – rich in vitamins A, C, K, B6. Also contains potassium and folate.
  6. Cauliflower – rich in folate, fiber, and vitamin C.
  7. Persimmon – a good source of fiber and vitamins A and C.
  8. Pumpkin – this low fat squash contains vitamins A and C and is rich in fiber.
  9. Sweet potato – a great source of beta-carotene – this sweet tuber also contains potassium, iron and vitamins C and B6.
  10. Winter squash – a source of vitamins A and C, potassium, fiber and thiamin

Additional SourcesThe American Heart Association  and Livestrong.com

Photo credit: Robert S. Donovan / Foter / CC BY

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Novel Cholesterol Medicines are Around the Bend

drug bottles

Two new cholesterol-lowering medications are on their way to being released. Last week, a committee that advises the FDA favorably reviewed these medications. Genzyme’s Mipomerson and Aegerion’s Lomitapide are novel agents that will initially be prescribed for only a select group of patients with severe cholesterol abnormalities. Patients suffering from the homozygous form of Familial Hypercholesterolemia, a rare genetic disorder, will be able to receive these treatments in order to lower their LDL cholesterol and with luck, dramatically prolong their lives. Down the road these prescriptions will hopefully become available for others as well. In addition to the fact that two novel therapies will soon be in the armamentarium of doctors who treat patients such as these, it is important to appreciate non-therapeutic aspects of this development as well.

First, the two pharmaceutical companies have put tremendous resources into development the new drugs, producing two truly novel approaches to lipid lowering. The ramifications of their developmental research are likely not yet fully understood. Science grows in angles, not straight lines – the knowledge gleaned from developing these drugs will likely lead to diverse paths of new R&D, bringing physicians new strategies for treating a wide range of disorders. Second, these companies have put tremendous resources into developing treatments for what we call an orphan disease, a super-rare disorder. Without the help of these companies, many patients would be left untreated, their fate, certain death.

Finally it is important to remember that although people often bash the “greedy pharmaceutical industry”, a great deal of good comes from their efforts. You see that with these two drugs, but actually there is much more. Pharmaceutical companies spend millions of dollars in unrestricted grants. With this money, doctors are educated about diseases without ever being “sold” a particular medicine or therapy. As amazing as this might sound, without the generosity of pharmaceutical companies, practicing doctors would be far less educated. So before we unduly criticize the pharmaceutical industry (a popular pastime these days), let’s be sure we fully understand what they are about. From where doctors stand, pharmaceutical companies care just as much about educating doctors and nurses as they do about their own bottom line.

photo credit: genzyme.com

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Is anyone out there truly “fair”?

2012 is the year of the “fairness debate”. Politicians and laypeople argue daily about what policies are or are not fair. The Merriam Webster Dictionary defines fairness as, “marked by impartiality and honesty: free from self-interest, prejudice, or favoritism”.  Nowadays, “fairness” is tossed about like a football, something concrete, tangible, and easily discernible. The dictionary would support an objective use of the term; yet, in fairness, the term is being used in an entirely subjective manner; what is considered fair to one is often quite unfair to another. It seems our debaters are misusing the word. They are judging fairness to suit their needs, even when aspiring to portray impartiality and generosity. Let’s examine some examples.

Ben Affleck recently told Bill O’Reilly that he wanted to pay “my fair share of taxes”. O’Reilly quickly retorted, “You want to pay 45 or 50%”, to which Affleck stated in an unfiltered fashion, “No, I thought we were going back to the pre-Bush tax level.” Translation, “that’s more than I bargained for. That would not be fair.” But what makes an Affleck tax of 35, 40 or even 60% fair? In fact, as Affleck can earn $10,000,000 for a role in a single movie, why shouldn’t he pay 90% in taxes? That would still leave him with a cool million for simply playing a part in a movie. Most might think that earning well over ten times the annual income of most teachers for a single movie gig is more than fair. Affleck of course would disagree. And so “fairness” should not be part of his vocabulary with regard to his views on tax reform. He is not impartial.

How about the fairness of our current medical system? Would the homeless family struggling to stay together and put food on their makeshift table think it’s fair that our country puts healthcare for all before shelter and food for the needy? Probably not. But most Americans do believe this to be fair. That is why we are in the process of expanding our medical coverage. And so the minority dwellers of the street have their sense of fairness trumped by the majority. It’s not fair, but it is the way our country works.

The football players strike when they earn less than they feel they are entitled to, and yet they make millions… for playing a game. Doctors have had their incomes systematically shredded over the last few years. Cardiologists for example have had their primary sources of income cut 40 to 50%! Fair? Consider what it takes to become a cardiologist. (Full disclosure – I am one). First you have to be a serious junior high school and high school student. That is correct; you must focus at a young age, abandoning the frivolities of normal youth. Then you must attend college, typically an excellent private University to enhance your chances of entry into medical school. I attended Columbia; price tag today, approximately $240,000. Then there’s Medical School. That’s another four years with an additional price tag of about $300,000. Most parents cannot afford these costs and so they spend everything they can and pay the remainder in loans. Consequently students often begin their next phase of medical training already saddled with well over $200,000 of debt. To become a cardiologist you then must complete three years of internal medicine training and an additional 3 years of dedicated cardiology training. That’s six years after medical school and ten years after college! Meanwhile, don’t forget the lost opportunity this student of Medicine has experienced. While he or she has accrued mind-boggling debt, his or her college friends have had ten years in the workforce to climb the ladder, earn money, buy homes, and start families. But that’s not it for our budding cardiologist. Say he wants to specialize further, to become an interventional cardiologist so he can save you when you’re in the throes of a heart attack. That’s another two or even three years. So how much should this super-trained doctor earn? Should it be more than the football player or the actor in a movie? When you are in the midst of a heart attack looking up at him from the gurney, what do you tell yourself he’s worth? What’s fair?

Let me digress for a moment as you might be saying to yourself, “but for doctors it shouldn’t be about the money. They should go into medicine to save people’s lives, to help the sick and keep the healthy well.” And you would be correct. Doctors shouldn’t practice medicine for the money. And most of them, myself included, don’t. But there are pragmatic issues. We too have families to support, children to send to college (and hopefully Medical School), houses that develop leaky roofs, and yes, food to put on the table. So early on, when we decide what path to take in life, these practical issues merit consideration. We are not choosing to go into the priesthood as some would suggest; we are truly selecting a career path. And the balance sheet of pros and cons that everyone considers in making important decisions must be looked at with a discerning eye. That is after all the smart way to do it. And believe me; you definitely want your doctors to be smart. So please don’t get hung up on whether or not doctors ought to think about their incomes. They do because they must.

Back to fairness. Whatever side you are on in this highly contentious political and social moment in history I simply want to suggest that the fairness card should not be on the table. “Fair” is intended to be an objective concept, but who among us has the genuine capacity to be completely unbiased? Instead of clothing the debates in false garments, let’s instead examine the real issues. Let’s look at how we see ourselves, our country, and most importantly our children’s country. No one is right or wrong here. It’s simply an issue of divergent visions for our nation. My suggestion to us all is to find a way to be as open and honest with ourselves as possible. We must educate ourselves to the best of our ability, swiping away bias and false information like bothersome gnats on a hot summer’s night. Then we can look at the issues with clarity and on November 6th go to the poll and pull the lever that feels right for us.

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It Really is a Wonderful Life

Having been in practice over 20 years I have a group of patients who are approaching the end of their lives. They share the angst associated with aging, losing friends and loved ones and understanding the inevitable end that awaits them. It is a sad and difficult time of life.

Last week when talking to one of these aging people, I mentioned that as physicians, throughout our lives we are repeatedly confronted with death. It struck me just how skewed a doctor’s perspective is. We are never permitted to hide from the truth; any one of us can die at any time. Although our understanding of life’s vulnerability is more accurate than the average person’s, their ignorance in this circumstance clearly offers greater bliss. Most people travel through life ignoring the truth about their own mortality. Although they occasionally experience a brush or two with death, it does not stare them squarely in the face day after day. One might surmise therefore that a doctor’s greater grasp of life’s true blessing should impart some sort of wisdom that would be internalized. We should glide through life more easily, appreciating the splendor each day brings. Unfortunately it’s not the case. Instead, we often become damaged by our knowledge and fail to use what could be wisdom, instead allowing our understanding to taint and often harden us. Although I am cognizant of these issues, I too struggle daily to appreciate what I have. Although I intellectually recognize how I should see the world, I find it difficult to put my knowledge into action. So why am I writing this today? Just to share the truth. Maybe some of you reading this note will be able to succeed where so many of us have failed. Embrace each day; breathe a bit deeper and easier; and take nothing for granted.

BBC “It’s a Wonderful Life Video

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Step Aside Evidence Based Medicine; Personalized Medicine is Around the Bend

I just read an article by geneticist and Stanford University professor; Michael Snyder, PhD. Published in Cell Dr. Snyder’s article describes his iPOP, or Integrative Personal Omics Profile. IPOP includes an assessment of not only Dr. Snyder’ unique genetic makeup, but his particular and ever-changing production of proteins, antibodies, and other players in his distinctive metabolism. Besides the obvious awe I experienced in seeing what is now possible through blood analysis, I was equally struck by something else. I recognized that our current system of Evidence Based Medicine (EBM) cannot coexist with true personalized medicine. Evidence Based Medicine rests upon findings from randomized clinical trials (RCTs) in which thousands of participants are studied to determine cause and effect of a variety of things – medications, vitamins, and surgical procedures… These RCTs evaluate groups of people and then apply their findings to an entire population. We base most of our clinical decision-making upon RCT results. But, we now know that no two people are exactly alike. So how can we assume that a drug or procedure will have the same effect on one person, as it will on another? In fairness, we can’t. And so, EBM must die. Until iPOP has a wide enough application however, EBM is the best we have to offer. So don’t throw away your medications or your doctor’s advice. Not just yet, anyway. The good news though is that iPOP appears to be right around the bend.

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