Oops! Don’t Buy Chocolate Milk for Concussions

No, really. This is a real thing, created by money. Oops, I meant to say, created by researchers and institutions with MAJOR conflicts of interest. Why post it? Well, while this is the most blatant example we’ve seen in a long time, it happens every day, even to well-meaning researchers.

silhouette arrow to dollar signFACT: research is a money game. If your proposal piques the interest of a funder (e.g.  government (public), private foundations, commercial companies), you get to do your research. Researchers are eternally grateful because, otherwise, they have to find a new career. Many proposals are worthwhile and survive rigorous grant review (including serious peer review) to qualify as “good science.” This one didn’t…

Note: always be wary of overly-enthusiastic researchers

The chocolate milk story shows how urban legends are founded, and never die. This story came to light because it was PUBLICIZED without the necessary data from the Public Relations or Press Release (PR) office, not PUBLISHED (as in a scientific journal).

While I always hope for the best in research, skepticism is a good thing. Why are good scientists inherently skeptical? Because researchers can quickly lose their objectivity and tout success based on hope, not on facts. In the worst cases like this one, their ‘hope’ can turn to hype, fame and/or fortune. It takes constant vigilance by each scientist, and the whole research system, to make sure facts lead to relevant conclusions instead of ego.

Unfortunately, news aggregators, like prnewswire.com, also spread false hype without question. By the way, University of Maryland (U MD) has since removed the press release since the ‘scandal’ began.

“There are real consequences to PR spin of health research.”

Andrew Holtz, Yoni Freedhoff, & Kathlyn Stone, HealthNewsReview.org reviewers

In this case, consequences for people included mass purchases of this particular chocolate milk by school athletic departments, as reported by Quartz and others. Unfortunately, the sugar content is very high, leading to other issues involved in dietary studies (see the post Quality Diet Research Needed for more on this). Consequences for U MD aren’t done yet.

Concussion/milk study: fact or fiction? Cow - dairy

But I digress – let’s get back to the study. HealthNewsReview.org first commented on a U MD press release (PR), giving it a 1 out of 5 rating on January 5th, 2016 (that’s bad). They couldn’t get any study information (data) because it had not been published.

This was picked up by other news sites later in January, such as Stat News and NYMagazine Science of Us, claiming more bizarre issues with the study. The only reason Retraction Watch wasn’t involved – the study was never published.

“…a scandal that touches on vital issues of scientific ethics, the collision of money and research, and the lightning-quick pace at which pseudoscience can lead vulnerable people astray. And it all boils down to a simple question: How the hell could the University of Maryland have allowed this to happen?”

Jessie Singal, Science of Us

Then, on April 1st (no joke), CBS News reported that U MD “disavowed” the study and would give back the $228,910 to the company who sells the milk and sponsored the study. I learned about it from this Huffington Post sketch.

All of this adds to other examples of concussion research conflicts in which the National Football League (N.F.L.) is embroiled, as reported by The New York Times.

But Deb, You Don’t Do Concussions!

Web research

True, I usually cover research in cancers and infectious diseases. So? This deals with a universal research issue that impacts millions of patients and people. Seriously!

Research is often done well, by researchers who care and follow ethical principles. Even the good ones with whom I’ve served on countless committees and review panels, however, can let ego, opportunity, and fame trump true objectivity. Many are also led down conflicted paths by their institutions who smell money, and are willing to give undue influence to sponsors in return.

Frankly, we need set Standard Operating Procedures (SOPs) for these kinds of conflicts for ALL academic research institutions (after all, that’s what standard actually implies). For instance, don’t do it in the first place. But, when a conflict is discovered:

  1. Give the money back (in process).
  2. Recall the erroneous information (check).
  3. Fire the researchers involved (not yet).
  4. Publicize the error and steps taken to resolve the problem through the SAME CHANNELS + others (not yet).
  5. Share the data so others can learn from it (not yet). Doesn’t matter if it’s bogus or not – everyone can learn and take steps to make sure it doesn’t happen again.

Health/medical researchers and their institutions/companies HAVE to understand that their work impacts lives. They MUST start policing their own, or others will do it for them.Important Stamp Shows Critical Information Or Documents

The references I listed in this article aren’t hard to find. It takes some effort, but it should represent the least amount of effort we all put into study results to make sure the claims match the data. So, thanks HealthNewsReview.org and others!

Got research? Do it right, or suffer the consequences.

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

A Plan for Real Research Improvements

Looks like 1,772 of us posted public comments about medical research informed consents to the NPRM docket! I realize this sounds obtuse, but bear with me through this post – please!

So, What’s the Big Deal?

The final regulation will affect millions of patients, researchers, institutions, and companies. These rules last changed in 1991. You know, before the internet existed for mere mortals. Just after my first cancer, while I was still a Silicon Valley computer executive. When Terminator 2 was new. Before my son was born. But I digress. Background on research informed consents is in this post.

Important Points for Patients

Unfortunately, informing patients about research has too often become a check box as CYA (cover your aspirations) for institutions. Big business. Instead of a straight-forward PROCESS that tells people what to expect so they can agree (consent) to take part in research (or not). Seems simple, right?

Rather than lament, my comments explain how systemic changes should happen. But don’t hold your breath. BTW, I had to write a preamble due to the 5000 character limit. That ticked me off (!), so I wrote this introduction:

“My individual comments are listed in the attached letter, although as founder of Patient Advocates In Research (PAIR), I have helped thousands of patient advocates partner with the research system for over 20 years (and am personally a survivor of multiple cancers).

Since you have received so many concerns from researchers and IRB members, it seems appropriate to add to the sparse patient perspective that appears in the NPRM public comments. Here are a few key points, in addition to my attached letter:

  • It is past time to embrace technology that can help deliver a modern approach to informed consent for trial participants, instead holding fast onto antiquated mindsets, procedures and reliance on paper forms.
  • This is too important to limit comments to 5000 characters, hence the attachment. I have participated in far too many informed consent committees to rely on an ‘executive summary’ approach to comprehensively address the NPRM.
  • Please eliminate the terms “human subject” and “research subject” from all federal regulations. My premise and recommendation is attached.
  • Informed consent is a process, and should be acknowledged as such in federal regulations. The form is a check box.
  • The NPRM, HIPAA, and any other related regulations should NOT be viewed in isolation, but rather WITH the rest of healthcare. Regulations should state that all agencies should work together in an adaptive infrastructure to ensure rules are kept up to date in our changing world.

Thank you for the opportunity to comment on the proposed changes to the Common Rule, which is of utmost importance in protecting research participants (i.e. people) while fostering research. In this historic shift to modernize the Common Rule, the NPRM should create an adaptive infrastructure that allows for evolving science while supporting responsible participant partnership, choice, and engagement. Please view my comments in the attached letter as a complete package.”

The Whole Letter

Pages from NPRM public comments 1-6-16PLEASE read the details in this pdf. It’s not long, and posits a new adaptive approach to create an open, welcoming research system. We can actually push this forward with your help!

So, What’s Next?

You can see the 1,772 comments here – if you know the Comment Tracking Number (mine is 1k0-8n8m-6xee), you don’t have to look through all of them.

I have no idea how the comments will be used, but they promise to read and consider them. The research community has waited for years to get changes to the Common Rule. No one knows when the final rule will take effect, but it’s a safe bet it won’t be before 2018.

Please join the discussion about making research accessible and open – make it REAL for PEOPLE!

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.