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Originally published in Movement Disorders Journal

(April 3, 2017 – online Early View section)

Media Hype: Patient and Scientific Perspectives on Misleading Medical News

Israel Robledo, BBA1 and Joseph Jankovic, MD2*

1Michael J. Fox Foundation Patient Council, New York, New York

2Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas, USA

 

This invited viewpoint article was motivated by a guest blog post on Scientific American1 by one of the authors (IR) diagnosed with Parkinson’s disease (PD) at age 42, who works as a special education teacher in Midland, Texas, and also serves as a member of the Michael J. Fox Foundation Patient Council. The first part of this article provides his perspective on the problems generated especially in the social media by the “hype” about exaggerated and unfounded claims of PD “cures.” The second part attempts to place these declarations in a scientific perspective.

Patient Perspective

Once a medical report is posted on a new media platform, there is little that can be done to fully retract the information. It has been heard on more than one occasion that “once it is out on the Internet, it is there forever.” Whereas careful and measured information authored by knowledgeable experts that goes out to the patient community can cause much good, the same media conduits can disseminate sensational-sounding but inaccurate medical content.

A case in point is the open-label, 12-patient nilotinib report that was initially published as a brief abstract at the Society for Neuroscience meeting in Chicago on October 18, 2015. This small safety study was not designed to test the drug’s efficacy, but the report had the temerity to claim that “If these data hold out in further studies, Nilotinib would be the most important treatment for Parkinsonism since the discovery of Levodopa almost 50 years ago.”2 Because one of the authors is living with PD and has a limited scientific background, but a keen interest in knowing the latest in PD research, he wondered if this lofty announcement meant that nilotinib would revolutionize research. How can one argue against what many in the PD community would think of as a “miracle drug” or “cure” for PD? How does one answer a patient saying, “The study shows that it works. Why would you not want to give it to everyone with Parkinson’s disease?” But in fact the report raises a serious ethical issue—namely, the damage caused by raising false hope. As a member of the advocacy community working at increasing clinical trial participation and advocating for increased federal funding along with other sources of research funding, state- ments and reports of the nature found with the nilotinib open-label study can complicate this work in several ways. For example, if a medication currently on the market is being described as “life-changing” and the best thing for PD in 50 years, why would a potential clinical trial volunteer bother with enrolling in lengthy studies when all he or she has to do is contact his or her primary care physician and request an off-label pre- scription for the medication? (It is earnestly hoped that this would not happen, but social media activity has actually indicated that some members of the PD community have been granted prescriptions for such.)

Publicizing limited data that have not been held to the highest standards of peer-reviewed research through news media is careless at best and can be con- sidered dangerous in the worst-case scenario. Few people who read the news reports have reason to doubt what has been reported, yet instances such as this and so many others that go beyond the norm in reporting and claiming unbelievable results and far-fetched expectations are not helping the cause of using sound, scientific research models to help the very people they have committed their lives to helping. As patients and volunteers continue to do their part in the clinical trial process and advocate for federal research funding, the research community needs to be considerate when making claims that could be misleading or claims that could potentially harm many lives.

In one of the authors’ comments on fake news in social media in a Foxfeed blog,3 he appealed to both patients and the media to educate themselves and others about so-called “miracles” and to consider the source of the information. He asked the PD community—including family and friends—that they take a more tempered approach to what they read and with what standards they judge, especially in the online world. The need is great and the responsibility is even greater. To the media and the grassroots social media community, please, dig deeper and make sure what is promoted is the real deal. Readers want to believe you. Our hope is that the discussion continues about what information people rely on and the validity of such information.

 

Scientific Perspective

The abstract referenced earlier2 has since been published as a full peer-reviewed article4 in the Journal of Parkinson’s Disease along with an editorial titled “Nilotinib—Differentiating the Hope From the Hype.”5 It is still not clear why this particular small, open-label study received such unprecedented news coverage in the world press and in social media. As a result of the enormous publicity, patients have been asking about this new treatment for PD and in many cases have demanded off-label prescriptions for nilotinib. The drug is currently approved by the U.S. Food and Drug Administration for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia. Although effective as a chemotherapeutic agent, nilotinib (TasignaVR by Novartis, Deerfield, Illinois) is not only expensive but also it carries a black box warning because it can cause QT prolongation and an irregular heartbeat, which may lead to sudden death.

The rationale for the original study was based on the hypothesis, supported by some data in animal models, that nilotinib, a tyrosine kinase Abelson inhibitor, penetrates the blood–brain barrier and reduces misfolded synuclein pathology and oxidative stress and also increases dopamine levels. In the published report,4 12 patients, only 1 whom was diagnosed with PD and the others had dementia with Lewy bodies (n 5 5) or some other parkinsonian disorder associated with cognitive deficit (n56), were randomized into groups with daily doses of 150 mg (n55) or 300 mg (n 5 7). An average decrease of 3.4 points and 3.6 points in the UPDRS-III, motor score was observed at week 24 compared to baseline with 150mg and 300mg nilotinib, respectively. Although the authors concluded that “Nilotinib may be safe and tolerated,” they acknowledged that “most participants experienced increased psychotic symptoms (hallucination, paranoia, agitation) and some dyskinesia whilst on Nilotinib.” Furthermore, 1 participant suffered myocardial infarction. CSF synuclein was slightly reduced at 2 and 6 months when compared with baseline in the 150 mg nilotinib group, but was unchanged in the 300 mg nilotinib group. Despite these relatively disappointing results in a small sample of patients, most of whom had the combination of parkinsonism and dementia, the authors concluded that the findings “warranted to evaluate the safety and efficacy of Nilotinib in larger randomized, double-blind, placebo-con- trolled trials.” As noted previously, the unprecedented publicity following the 2015 presentation of the abstract in the media exaggerating the findings, refer- ring to nilotinib as “the most promising new treatment for Parkinson’s disease in decades,”6 presents not only a disservice to the PD community but also is potentially dangerous. Thus, despite a lack of credible scientific evidence regarding the drug’s efficacy or long-term safety, some doctors are now pressured by their PD patients to prescribe nilotinib. In response to the need for evidence-based data, the Michael J. Fox Foundation for Parkinson’s Research is planning to launch a well- designed, controlled trial of nilotinib in PD sometime in 2017. In the meantime, Todd Sherer, PhD, Michael J. Fox Foundation for Parkinson’s Research Chief Executive Officer, cautions patients and their physicians “not to add Nilotinib to their Parkinson’s treatment regimens until more is understood about the safety and possible effectiveness of the drug in PD.”7

The nilotinib story is merely one of many that exemplify the growing trend toward blurring the line in the news media between fact and fiction. Indeed, partly based on political campaigns in the United States and Europe, the Oxford Dictionary has selected “post-truth” (“relating to or denoting circumstances in which objective facts are less influential in shaping public opinion than appeals to emotion and personal belief”) as the 2016 international word of the year.8 In many cases, grossly exaggerated, untrue, or even fake news have infiltrated the main stream and social media by publicizing false medical information without any accountability or concerns for the safety of patients who are often grasping for straws in their des- peration to find a cure. Although the reasons behind the disinformation is not always clear, in many cases the purveyors of fake news are motivated by political agenda or simply by a desire for sensationalism. One example is the claim during the recent U.S. presidential election that Hillary Clinton has had PD for at least 10 years, and in a television interview a neurologist concluded that Mrs. Clinton suffered from a “critical and debilitating medical crisis” and that “the truth is beyond the shadow of the doubt that Hillary Clinton has PD.”9 The neurologist supported his statement by claiming that her near-fainting spells were examples of parkinsonian freezing and that she had “head-nodding tremor,” “oculogyric crises,” “head bob- bing levodopa-induced dyskinesia,” “bradykinesia,” and other unsubstantiated observations.

Profits may be another reason for medical misinfor- mation in the media. This is exemplified by the extraordinary marketing campaign behind vitamins, supplements, gluten-free diets, and so on. Although most patients are increasingly and appropriately con- cerned about the growing cost of prescription drugs, few realize that they spend as much or even more money on these various alternative products. In the 2007 National Health Interview Survey, approximately 38% of adults reported using complementary and alternative medicine in the previous 12 months, resulting in an estimated 11.2% ($33.9 billion) of total out-of-pocket expenditures on health care.10 Besides the lack of scientific evidence for any meaningful efficacy of these over- the-counter drugs or dietary strategies, there is generally a lack of awareness about their potential dangers. An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements.11

One of the most frequently asked questions by patients is “will marijuana help my PD?” Despite the lack of strong evidence that cannabis is effective in the treatment of PD or levodopa-induced motor fluctuations and dyskinesia,12,13 many patients relate personal anecdotes of how smoking marijuana or ingesting marijuana edible products “calmed” their tremor and dyskinesia and exerted other beneficial effects on their symptoms. One video14 that has gone viral depicts an individual with presumed PD and levodopa-induced dyskinesia who, with the help of a fellow PD patient and marijuana advocate, takes a few drops of cannabis oil under his tongue and within a few minutes his involuntary movements subside. Although this could simply represent wearing-off effects, this is followed by the following statement: “Please continue to help us spread the word on the benefits of medical marijuana and share Larry’s story with the world.” Although the U.S. government owns the patent (U.S. patent 6630507) on potential neuroprotective effects of cannabinoids in “the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia,”15 there is currently no evidence that this class of drugs (still illegal in many states in the United States and other parts of the world) has any disease-modifying properties.

 

Another frequently asked question, largely based on much hype in the news media, is the following: “Why can’t you give me stem cells?” There are growing con- cerns among stem cell researchers and the scientific community at large about the degree to which the media’s overly optimistic reporting of unrealistic expectations of outcomes from stem cell interventions.16-19 Although there have been many unfounded claims of “cures” as a result of stem cells attributed by various commercial companies and other for-profit entities with potential conflicts of interest, the field is now rapidly accelerating, and new trials of widely different qualities are planned in many centers around the world. One clinical trial,20 recently initiated by researchers at the Royal Melbourne Hospital, Australia, claimed to have “successfully injected” millions of stem cells into the brain of a patient with PD. Although no long-term efficacy or safety data has been reported, this study has received enormous worldwide publicity. Despite some prospective clinical trials with fetal and adult stem cells, this therapy has remained largely experimental and unregulated and thus not yet accepted by the general scientific community.21 Indeed, many researchers have raised serious concerns about the scientific merits and ethics of some of the trials and the possibility that these stem cell interventions may put patients at risk. Therefore, new guidelines for stem cell research and clinical translation have been recently released by the International Society for Stem Cell Research.22

On December 13, 2016, President Obama signed the 21st Century Cures Act into law, a $6.3 billion measure “to increase federal support for medical research, mental healthcare and controlling the opioid epidemic,” which includes $1.5 billion over 10 years to the National Institutes of Health for the Brain Research Through Advancing Innovative Neurotechnologies Initiative, a program that supports the development and application of unique technologies to help researchers better understand the brain and treat conditions such as PD, Alzheimer’s disease, and depres- sion.23 The bill also provides $30 million for clinical research to further the field of regenerative medicine using adult stem cells. The renewed scientific interest and new funding will hopefully lead to well-designed clinical trials that will address the scientific, clinical, and ethical issues surrounding stem cell therapy in PD.

Other examples of controversial medical topics related to PD and other movement disorders that have recently received much media attention, not discussed in this review, include the following: intravenous treatment with glutathione for PD,24 resveratrol treatment for PD and tremor,25 mannitol,26 the use of gut microbiata as a biomarker for PD and also a potential therapeutic target,27-29 early versus late application of deep brain stimulation and the relative advantages and disadvantages of focused ultrasound,30,31 placebo effects in medical and surgical trials and the dogmatic insistence on the practice of evidence-based medicine according to rather arbitrary guidelines,32-36 and unfulfilled promises of animal models.37,38

The misleading medical news related to PD goes beyond therapeutics. For example, recently discovered blood neurofilament light chain protein has been found to possibly discriminate between PD and atypical parkinsonian disorders.39 Although it is found to be at normal levels in PD, similar to healthy controls, but elevated in progressive supranuclear palsy, corticobasal syndrome, and multiple system atrophy, one publication wrongly claimed it to be a “simple blood test to diagnose PD.”40

It is beyond the scope of this review to cover all aspects of exaggerated and unfounded reports that not only provide misinformation but also false promises that lead to false hopes, expanding medical tourism, online predatory marketing, and other unscrupulous practices. Furthermore, there is a growth of fake medical journals that provide not only hype and exaggerations but also disinformation.41 It is hoped that, by drawing attention to some of the published exaggerated or false medical statements, patients and physicians become more vigilant and critical of information disseminated publically through the press, television, and social media and exercise their best judgment when interpreting the information and preventing potential harm. To aid in this effort, some nonprofit organizations and physician groups have developed websites, such as http://www.factcheck.org42 and http://www.alsuntangled. com,43 that serve as clearing information houses for patients and physicians to help them guard against potentially dangerous disinformation and “alternative facts.”

 

There is no easy solution to the current dissemina-tion of misleading medical information through social media. Professional organizations, such as the International Parkinson and Movement Disorders Society, should establish guidelines for researchers to follow when they communicate their findings to media outlets. The authors also urge patients and physicians to access accurate information about clinical trials and other research developments through reliable websites that post peer-reviewed articles and other credible data, such as PubMed44 and Clinical-Trials.gov.45 It is important to point out, however, that these websites also may provide misleading information. For example, recently three patients became blind after unproved stem cell treatment that was listed on ClinicalTrials.gov.46 Nevertheless, these resources usually provide access to scientifically sound information about extraordinary progress that has been made in the field of movement disorders during the past 200 years since James Parkinson first described the condition that bears his name.47

 

Related articles:

Scientific American

https://www.scientificamerican.com/search/?q=robledo

Davis Phinney Foundation Articles

https://www.davisphinneyfoundation.org/blog/tips-for-separating-parkinsons-facts-from-online-fiction/

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