The War on the Declaration of Helsinki

The Declaration of Helsinki is the International guidepost for research ethics that has been adopted by the World Medical Association. Its Wikipedia page says it all:  “It is widely regarded as the cornerstone document of human research ethics.” So why are some American academics attacking this critical human document? Because there are parts of it that challenge the several hundred billion dollar U.S. research machine-the commercial entity behind scientific research involving patients. Let me explain.

My first exposure to this document was many years ago at a research conference. A physician flashed a part of it up on the screen. He focused on the 37th paragraph, one part of the document that seems to have some academics “concerned”. It said, “In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.” Makes sense, right? If you were lying on your deathbed or you were disabled and your doctor told you traditional options weren’t good, you would want to have access to as many alternative treatment options as possible, even if some of those options were yet unproven. In fact, because Helsinki allows patient’s choice of their own medical destiny and puts most of the power in the doctor-patient relationship, it’s often the subject of trash talk by many academics. Why? The commercial medical research industry operates on the opposite principle, i.e. we need a third omniscient power over the doctor-patient relationship that knows best. Who? Can you venture a guess?

The U.S. FDA, the ultimate third party superpower, has also abandoned the Declaration of Helsinki. This is because there are other parts of the document that challenge the cornerstones of the U.S. drug approval system. For example, chapter 33 has the gall to assert that the use of a placebo in research may not always be the most ethical option. A placebo, or fake medical treatment, is the basis for all U.S. drug approvals and is something that the medical research industry prizes like a sacred cow crossing the road in India. In fact, the placebo is what keeps many practicing physicians out of performing medical research, as it can be an expensive and logistical Albatross. In addition, since a physician’s first duty is to the patient, many doctors can’t stomach the idea that their suffering patients might not receive any care in a study. This is especially true of patients who have life threatening illnesses, where the patient is being used as a human Guinea pig, i.e. the overall purpose of the research isn’t to benefit that individual patient, but instead, to pursue abstract knowledge (i.e. is therapy A better than a placebo).

In addition, since human Guinea pigs in placebo studies need maximum protection from the research itself, an entire field has grown up to protect them. Called bioethics-it’s defining concepts were born in the crucible of documents like Helsinki and Belmont (its U.S. equivalent). The goal of the field is to be the research referee. Most bioethicists work for universities. Now back when universities had little financial stake in research, the universities themselves weren’t in the same category as commercial businesses and these bioethicists were the new priests and priestesses of our time. However, the Bayh-Doyle act of 1980 changed all of that by allowing your tax dollars to fund public research at universities and then giving the university the green light to turn that research into patents that can be commercialized. 

Perhaps a Stanford University document put it best: “The last two decades have witnessed a sea-change in relationships between universities, industry and the federal government. Beginning in the early 1980s, key federal policy changes enabled small businesses, public and nonprofit organizations, including universities, to hold title to intellectual property (IP) developed during the pursuit of federally sponsored research and development (R&D).  Since then, research universities have developed increasingly close ties to the world of commerce.” 

Basically, your tax dollars fund new discoveries, and the universities that use those tax dollars get to keep the proceeds from patents, licenses and new businesses that arise to commercialize those discoveries. In addition, the scientists who make these discoveries also get a cut of the action, earning a percentage of the money that will be earned by their patented inventions. Finally, universities budgets grow ever bigger, and bioethics departments benefit.

Could this be why some U.S. academic bioethicists get confused between a true placebo medical experiment and a doctor trying new types of medical care in a patient with few options? I have seen bioethicists working for these university interests declare that a patient receiving a stem cell treatment in a clinical study where they might also get a placebo, needs the exact same protections as a patient who is being treated with stem cells to try and help the patient (sans placebo). These are obviously very different situations, one where the patient is a true Guinea pig as the purpose of the research isn’t to benefit the individual patient (i.e. that patient may not be treated at all), the other where the doctor tries to heal or help the patient. Yet in the stem cell debate, U.S. academics often seem to purposefully equate these two as being identical situations. The news media, who has never heard of Helsinki nor Belmont, often takes the bait hook, line, and sinker without checking the deeper facts. For example, they don’t know that Helsinki allows for this type of investigative medical care.

Last night on Twitter (during my beloved FSU game no less!), some academics were again beating up on the newest proposed version of Helsinki. Why? Because it continues to strip the power from the commercial medical research industry (made up of Pharma, Universities and the FDA) and place it in the hands of the doctor and patient. The seminal research rights document still doesn’t like placebos, instead favoring medical research that’s more commonly performed by physicians than universities-i.e. is real therapy A better than real therapy B (for which a university isn’t generally needed). This trashing of Helsinki follows a decade long war on the document being waged by academics involved in this commercial research industry. However, I ask you, what’s not to like about a document that puts the power between you and your doctor?

The upshot? I don’t dislike universities, bioethicists, nor placebo studies. Our medical practice has three randomized controlled trials that it’s recruiting for right now. These use the more patient friendly cross-over design, but in the right circumstances, placebo studies can be very powerful. In addition, most university scientists and bioethicists toil in obscurity to benefit the greater knowledge of mankind-they are a gift to us all. However, stem cell science is a hot commercial area right now for many universities. In this one instance, universities are no different than businesses who protect their business interests. In this case, a war on Helsinki is simply collateral damage in a quest to keep on top of the commercial heap.

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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