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March 16, 2016

Why Bad Medical Research Might Get Published

medical research5 Reasons for Bad Medical Research

In Is The Paleo Diet Unhealthy? we alluded to the fact that at times bad medical research gets published and that such research can do significant harm. Not only that, but it can take years to overcome that harm. So why does bad medical research get published? In this article we offer five explanations. These include:

  • need for studies to publish that exceeds the pool of good research.
  • conflicts of interest related to ad revenue the journal receives.
  • conflicts of interest and bias among editorial board members and medical reviewers.
  • lack of expertise of editorial board members and reviewers in a particular area of medicine.
  • lack of enough critical knowledge on a topic to properly conduct and draw accurate conclusions.

Before we get into the reasons there are some things that need to be pointed out about today’s medicine.

Medicine is no longer the noble profession it once was, or at least not as pure and noble as it was once. Medicine has been hijacked by big business and medicine is now a big business, and it is a tainted one at that.

Numbers are what matter most today to big corporate entities in healthcare. How many patients did you see? How many MRIs did you order? How many flu shots did you administer? And, so on. Such numbers supersede quality of care in some cases.

Various groups – insurance companies, hospital systems, pharmaceutical companies, research centers –  are protecting their financial interests or stakes in the system as technology, scientific advancements, and politics challenge and change the system.

Need for Studies to Publish

Scientific and medical journals are also big businesses. What journals need to survive is an ongoing stream of studies to publish. The publish or perish philosophy does not just apply to researchers. It also applies to publishers.

At times the supply of good medical research is not enough to meet the content needs or demands of journals. Most journals are published monthly. They need constant content to stay afloat. To meet this constant content need studies of lesser quality or importance may find their way to being published.

We can relate to this mindset as we deal with it managing this relatively simple blog. We need to publish original content on a regular basis for this website to be considered an active website in the eyes of search engines. If we do not provide enough original content on a regular basis we lose our page ranks and with that comes a loss of traffic.

Conflicts of Interest Due to Ad Revenue

Journals, too, rely heavily on ad revenue not just subscription fees. And, this potentially leads to another reason why bad medical research gets published and why good research may not get published.

If you look at many medial journals they are filled with ads usually from pharmaceutical companies. Might that ad revenue influence which articles get published? Is a study that shows a negative outcome of a statin drug going to be published if that journal receives ad revenue from the manufacturer of that statin drug? And, conversely if a poorly done study on a drug shows a particular benefit might that article get published because the journal is getting ad revenue from its manufacturer?

We typically think of peer-review journals as being the more prestigious and reputable and most scientifically sound journals but many of the members of editorial boards and journals’ medical reviewers have outside financial interests related to medicine.

This is also a problem with the drug advisory committee of the FDA – the group that decides if drugs get approved or not. Many members of these advisory committees have financial ties with pharmaceutical companies. Read this article published in JAMA regarding conflicts of interest of Drug Advisory Committee Members.

While pharmaceutical companies can donate to political campaigns and thus influence who sits on state medical boards (usually appointed by Governors) they are no longer permitted to provide physicians with pens, note pads, and other small gifts with their drug or company name on them. Lawmakers feel that such token gifts inappropriately influences a physician’s prescribing habits – and maybe it does.

Yet, the medical and legal professions show less concern about the financial interests of editors and medical reviewers and those on the FDA Drug Advisory committees whose decisions greatly affect the practice of medicine impacting all of us. Some of these position holders have rather substantial financial ties to pharmaceutical companies, medical diagnostic manufacturers, surgical supply manufacturers, and durable good companies. We see one set of rules for the rank and file physicians and another for the academically “elite” physicians.

Going back to the FDA. The FDA receives approximately 60% of its funding for new drug applications from the pharmaceutical industry. In other words, the government agency that determines which drugs are approved is essentially on the pharmaceutical companies’ payroll. Apparently, that’s not a conflict of interest but providing physicians with pens is.

It is a system that shows favoritism and is ripe for conflicts of interest. Read this review from the Center of Ethics at Harvard University. The section called The Trial-Journal Pipeline discusses the pharmaceutical industry’s funding of the FDA and the how pharmaceutical companies manipulate and distort statistics to get its drugs approved and strategies they employ to get physicians to prescribe them.

We have progressed (if that’s progress or being progressive) to a system where pharmaceutical companies fund political campaigns of lawmakers who pass laws favorable to pharmaceutical companies who in turn fund medical research and academic institutions which then conduct studies showing how wonderful drugs are even when they are not through questionable research.

And, we wonder why the costs of medications are so much higher in this country than anywhere else. The first rule in evaluating medical research is to find out who or which organization funded the project.

The so-called standard of medical care is established by the state medical boards and medical societies which are influenced by the pharmaceutical industry (and other stakeholders in the healthcare industry) – a major reason why it may seem your primary care doctor wants to prescribe a medication for every complaint you may have – except when you ask for antibiotic, then they might say no.

As an aside.

This partnership between government and big business as we see with Big Pharma and the government is called Corporatism. Some call it crony capitalism. But, it’s not capitalism as much as it is a hybrid of capitalism and socialism. Corporatism enables the government to control an industry or society (socialism) through heavy regulation without government ownership and allowing private ownership (capitalism) .

But industries (medicine, education, banking, energy, etc) are so heavily regulated that government in essence “controls” them. Regulations are expensive to comply with which big business paradoxically likes as it protects big business from competitors. Through corporatism big business and government have found a way to work together with interests of each being met by the other (sleeping together).

I refer the interested reader to this article called American Corporatism by Robert Locke. If you understand this article you can see how medicine has evolved and better understand some of the changes in your health care. You will also get a better appreciation why it seems there is only political party with slightly different shades.

Bias or Differing Opinions Between Researchers and Editorial Boards

Editorial board members and medical reviewers may hold views that might be opposite of a well-designed research study that shows results that goes against mainstream thinking while poorly conducted studies that support mainstream thought might get published. They also may know a colleague friend engaged in a similar study as the one they are reviewing and may decline the study they are reviewing for publication.

Simply put there is much politics the higher you go up the medical ladder and that interest is usually aligned to maintain the status quo. New journals come into existence, in part, to provide an alternative voice or view on a subject matter when such voices are being silenced my mainstream publications.

Lack of Expertise

In some cases, medical reviewers and editors have less knowledge of a specific topic than the authors of a study and may not fully appreciate the nuances of a therapy. Or, the authors of a study may not fully understand the nuances of a therapy when they design a study. For instance, some recent articles on testosterone have been done by epidemiologists and cardiologists who have no experience actually treating men with testosterone and have failed to recognize that blood counts and other hormones must be monitored like estradiol and dihydrotestosterone to minimize risk. They wrongly concluded that testosterone raised the risk of cardiovascular events when it may have been an elevation in one of those two other hormones or blood counts that was the real culprit.

Or, they give improper doses. One study on growth hormone given to adult patients in the ICU gave patients growth hormone three days a week and on the days patients did receive growth hormone they were given seven times the normal daily adult dose and concluded that growth hormone caused harm in ICU patients. Well, you don’t make growth hormone three days a week. You make a little bit daily. The study patients ended up getting three times the weekly dose for an adult that would be considered normal.

The authors of that study also based the dosing of growth hormone on the growth hormone needs in the pediatric population. At the time of study growth hormone was being used almost exclusively to treat children with growth hormone deficiency. Growth hormone is the only drug where the pediatric dose is higher than the adult dose (as kids are growing and need more than adults). The authors of the study, nor the editors of the journal that published the study, took this into account. Adults just need a small amount of growth hormone daily to help healing.

It was a poorly designed study. Also, the reason growth hormone was given three days a week in that study was to make it easier for the nursing staff to administer it by saving time from having to do it daily. Imagine if a diabetic, instead of taking a little bit of insulin daily, calculated his weekly dose and gave it all at once at the beginning of the week to make it easier on himself. What would happen to him? He would go into a diabetic coma and likely die. In fact, that happened to a patient during my residency who did just that – and he died.

Editors and reviewers sometimes do not understand such treatment nuances and publish articles with faulty conclusions.

We are Not Quite as Smart as We Think

You can better tell how intelligent someone is by the questions they ask than the answers they give. The ability to ask thought provoking questions is where you separate true genius from those who are simply book smart – those who can regurgitate what they read or are taught. Genius goes beyond just knowledge. It involves insight and wisdom as well. It intuitively knows the right answer and asks the right questions to reveal that right answer. The problem is such genius is rare.

Ultimately, the right questions have to be asked if  you want to get to the truth about anything. And, that’s what research is all about – or should be. Getting to the truth about something. Medicine sometimes loses the forest for the trees and doesn’t know which questions to ask and can find itself going down the wrong path. Also, in some cases, studies have to be set up serially with each one providing answers so that the next study can be designed appropriately based on this new found knowledge. Many times you have to peck away at discovering the truth.

When you think about it engaging in any research takes a certain amount of ego or chutzpah. When you design a study you are essentially saying that you know enough of the topic and its intricasies to know which questions to ask and know how to control/account for all possible (risk) factors or conditions to come to the correct conclusion (truth) about something.

In reality, rarely is that the case. I think that is the major reason that in any field, specialty, or subspecialty of medicine there are only a dozen or so studies that are landmark – studies that really make a difference and alter how medicine is practiced for the better.

The Women’s Health Initiative is a classic example of poor study design and inadequate pre-study knowledge. The incorrect conclusions of that study have set women’s health back 10-15 years. Despite the general acknowledgement by the medical establishment today that it was a flawed study its findings are still perceived as gospel truth among many physicians illustrating the challenges in overcoming bad research.

No research is preferable to bad medical research. The harm caused by bad medical research should never be underestimated.

Have you ever wondered why every other year medicine comes to different conclusions on some topics? Why should medical evidence ever conflict if research is being conducted properly? Why in even years is there a link between caffeine and breast cancer, and in odd years there is no link, for instance?  Does it make sense that a diet or supplement would be good for the brain but not for the heart, or vice versa? Common sense says the body would not have been created that way, or evolved that way depending on your view. Study design, inadequate pre-study knowledge, and an inability to account for all factors is the reason we see these contradictory finings even in controlled studies.

In a sense, most studies are only as good as the next study that comes out. But, does the truth about anything ever change? No, it doesn’t. So why do research results change? Either caffeine contributes to breast cancer or it doesn’t. It’s one or the other, not both. Much of medical research is an estimate of the truth – nothing more. This makes practicing evidence-based medicine most challenging with ever changing goal posts. There is little medical evidence that can be considered absolute truth.

When the evidence is conflicting I default to common sense. And, a vast majority of the time really good medical research bears out common sense.

So these are five reasons why bad medical research might get published. There are certainly more. Not very comforting is it?

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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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