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 Clinical Trial Failed Patients

Something horrible happened – a clinical trial failed, causing one unexpected death and seriously injuring 5 people. And instead of dealing with a dysfunctional research system, “experts” are spouting off on their own. The few articles written to date focus on the drug (aka the money), not on what people want to know.

My Initial Thoughts

high wire climbing in the wood

ClinicalTrialsArena asked me to comment, due to my unique expertise that straddles the patient and research worlds. After researching the topic,* here are my concerns – most of which have not been discussed yet.

This poses a much larger question – why am I the one bringing these up?

Fact 1: Something really bad happened – the first 6 people to get “repeated higher doses” died or were seriously damaged. This is a clear sign of system failure (e.g. approval, protocol, procedures, formulation, PharmcoDynamics).

Fact 2: A phase 1 clinical trial means it is the first time a drug is studied this way in people. 127 people in the trial is far larger than classic phase 1, and most don’t have placebos. Isn’t this more like a phase 2, or the new-fangled phase 1-2 trial? If so, what happened to the rules?

Fact 3: The drug showed activity in laboratory dishes and animals first. We don’t know what mouse-realtesting was done, or for how long. How realistic are the animal models, and how closely do they relate to humans?

Fact 4: Existing articles stress the need for more ‘transparency’ to share the drug’s molecular structure. Patients want honesty first, which in this case may mean, who screwed up?

Fact 5: I’m a big believer (and trail blazer) in presenting trial results, but that’s when we have results. NOT during an ongoing, active clinical trial. Why aren’t we calling for the protocol to be publicly published immediately?

medical_1000006456-120613intFact 6: Healthy volunteers joined this trial after reading an ‘informed consent’ form about its procedures and risks, and they were paid well. Why isn’t the consent form (for every trial) publicly available once the trial is approved?

Fact 7: In the U.S., the Institutional Review Board (IRB) would be shut down and investigated before any new trials could be opened.

Fact 8: A thorough investigation on all parts of this system failure is obvious. This, too, should be open and as public as soon as possible, and at all times.

Fact 9: Risk is an inherent part of clinical trials because risk is part of everyday life. Even when rules are followed, bad things can still happen. Patients aren’t stupid, so there is no need to shut down other clinical trials.

A Setback for Other Clinical Trials?

Amazing we even have to ask this question, right? Of course it will!

Only other researchers may think their trial will be ok because, oh let’s see, because that trial was different – yes, that’s it! That trial (take your pick):

  •  was in a different disease
  •  was in a different country
  •  was run by a company I don’t know
  •  had a different study design
  •  was a horrible accident that would never happen to me
  •  add your own excuse

But patients won’t care about any of that. They’ll steer away from danger or discomfort. And let’s face it, anything called a “clinical trial” isn’t comforting. And as far as whether the rule were (or weren’t) followed – that doesn’t matter either. The rules in the case of a clinical trial include the protocol, of course.

I am firmly in the patient/participant camp. Some may call this a bias, but I consider it the only worthwhile endpoint. I know patients want better answers NOW, and I know people in research deal daily with regulations and hubris.

There was clearly a system failure here, and people needlessly paid too high a price. Let’s find out why and make the pieces work together so people won’t worry about needlessly putting their lives on the line.

* Online information (as of 1/21/16) about the French clinical trial from a Portuguese company is located on Facebook, at #clinicaltrials on Twitter, and is listed in articles from:

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.

Recuperation & a Re-Boot

Sometimes, my body says “If you won’t stop, I will.” Since the flu hit over the holidays, I re-grouped for the new year.

First, the above statement from Marianne Williamson appears every January 1st on “A Year of Daily Wisdom” calendar that I’ve used since 1998 (thanks, Mom-In-Law!). So, I’m going to unlearn the fear we hear every day and focus on the love that connects us all. Of course, some days will be easier than others… writing-week-participant-ipad-208x300

Next, I found a 7 day Writing Week challenge by ShelleyHitz.com, and decided to start the new year off with new skills.

Before all that, I finished 2015 by opening the creative channels of play. I mean, there is only so much rest a mind can take! In my case, play means making jewelry, which will come in handy for 2016 fundraisers. Let me know if you have one you want me to consider.
Necklace - Amethyst & fluorite    Necklace - Murano glass    Necklace - pearl and crystal weave

My play also led to an overflow of work ideas that you’ll see throughout 2016.

Happy new year!

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.

Informed about Changes to Research Consents?

Isolated patients need clearer informed consents to engage fully in research.

If not, you’ll be surprised soon. The Common Rule is changing – 1st time since 1991. The US NIH NINR says, “The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies.” Translation: these are the rules that apply to informed consent forms that patients sign to join research studies.

Your input (yes, you!) actually matters. Here is what you can do:

  1. Brush up on proposed changes: check out the summary, the full text in Federal Register, the public comments, and start thinking about yours as you read on.
  2. Comment by 1/6/2016 (was 12/7/15 originally) at the Notice of Proposed Rulemaking (NPRM). If you need the docket ID #, it’s HHS-OPHS-2015-0008.
    EDIT: the public comment period has been extended – post your comments before 1/6/2016.
  3. Be sure to remind them to STOP with this ‘research subject’ nonsense! People who join studies are trial participants, not subjects of some self-imposed royalty (or worse). And please ask them to require public study result summaries too.

If you want to post on your own, go for it. If you want to know my thoughts, read on…

“…bold moves to streamline the clinical trial process.”

Quorum Review IRB

Here is a quick summary of the proposed changes:

  • Tighter rules on explaining the study: shorter forms with key points highlighted for better patient understanding. Consent forms will become public. Hopefully, a step forward.
  • A written “broad” consent for all biological samples (e.g. leftover blood, surgery tissue) for any research, now or in the future. This includes samples that don’t have personal information attached, so each person won’t be identified.
  • Linking the level of risk with the type of Institutional Review Board (IRB) review.
    • Less risk = less review. A web-based decision tool will help figure this out.
  • More data security & privacy standards to protect trial participants’ confidentiality.
  • Requiring a single/central IRB for studies done at many sites.
  • Applying the Common Rule to all clinical trials in institutions that get federal funding.
  • Eliminate ongoing (continuing) reviews for some research.
Good review of Medical Ethics!

Good review of Medical Ethics!

For a quick refresher on ethical principles, please see the Belmont Report, and Medical Ethics for Dummies. It will make this much easier! This stuff matters – worth your effort.

So, what’s the big deal?

Many researchers think the new requirement of a written consent for all research samples will hinder medical advances. Until now, they collected samples from everyday medical care to use in research without each patient signing a form that says ‘yes, you can use my sample.’ Many of these samples had patient identifiers removed (called “de-identified” samples).

Translation: people working in the system chose which samples to take, and how use them. Some set up ethical methods, but patients weren’t involved in decisions (i.e., paternalistic).

Here are some arguments from the research perspective about changes (I’m paraphrasing):

  • This will negatively impact sample collections from the past (called “retrospective biobanks”). These samples are valuable because data (e.g., w/5 year follow-up) is useful now instead of waiting another 5 years if we start collecting now.
  • Changes only apply to physical samples, not data. Data also needs careful management to protect people from harm.
  • There is no oversight for the broad consent option, so how will we protect people from misuse? Issues like scarce samples, race and ethnicity, cultural norms, and harms to societal groups are not covered.
  • Changes create extra burden & cost on hospitals and clinics to use a broad consent form. Smaller places may opt out of research, which limits access to some communities.
  • Hesitancy to find patients for consent (or ask them about past samples), and the fear that many patients may not like being contacted.
  • Changes over-emphasize Autonomy (independent choice) vs. Beneficence (maximize benefit while doing no harm) and Justice (people affected should be offered access). See? I told you to check medical ethics first!

In a Perfect World…

This scenario may never happen since middlemen (like institutions) couldn’t make money off the data or samples, as many do now:

Patients would own their own samples, data AND electronic Medical Record (eMR/eHR). Healthcare professionals would interact with patients, but patients would be in total control of everything related to them. Flags in the record could be turned on for Y/N to donating research samples, data, etc.

BTW, how many current eMRs do you have? I’m up to 10 and many are wrong and/or incomplete!

My Take on NPRM Changes

I have worked directly with thousands of researchers for over 20 years, and I respect their dedication and efforts. Some have asked me if I can support their position on NPRM. After much contemplation, I have my own opinions regarding the proposed changes to the Common Rule (as usual). My current thoughts are:

  1. NPRM will change the way research samples are collected. It might reduce the number of samples that researchers have available if it is not explained well. That doesn’t mean, however, that people can’t decide for themselves.
  2. The arguments above represent a system averse to change, not on how to improve the research process and engage patients in new, open ways. Researchers are constrained by the old guard and fear extra burdens from the traditional research system.
  3. Modern social media and communication technologies can help find and engage patients. It takes new mindsets and methods, but old institutions don’t change easily. The NPRM should NOT be viewed in isolation, but rather WITH the rest of healthcare!
  4. Simple, direct plain-language consents can help people understand how samples have been used for years, and how they can continue to contribute to better care today. Some of us who create plain-language patient communications can help.
  5. New regulations (broad consent in this case) frequently allow for continuation (grandfathering) of older collections and procedures.
  6. NPRM must require specific oversight for the broad consent approval process. IRBs or usage committees should not be left out of this process, and a patient communication plan is CRITICAL.
  7. We should definitely include DATA (big, little & in-between) in the requirements. Data standards are desperately needed for research collections, which carry greater potential risk/harm than do body parts. Some groups are writing recommendation reports, but we need widespread action NOW.
  8. Extra burden? Every new initiative is an opportunity to make hospital procedures easier. Right now, patients give separate consents for any procedure they have done in a medical setting. While these are different from research informed consents, they are indistinguishable to most patients.

There are many more points, but I need to wrap up for now. Patients want to be more engaged, and this is an opportunity to better explain how the research community develops new treatments, procedures and tests that help people.

I frequently feel the need to remind ethicists not to “protect patients from themselves.” This is a step in the right direction (as long as they call us trial participants, of course!).

Involving those of us who represent patient voices in the implementation plans will help ensure that this works for patients AND those who serve them.

“…the ethical principle of respect for persons.”

NPRM 2015 Summary

All content © 2015 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.