Dietary Supplement Practicum 2018: Discussion with Industry & Watchdog Panels

Dietary Supplement Practicum 2018: Discussion with Industry & Watchdog Panels

September 29, 2019 0 By Ewald Bahringer


>>Paul Coates: While
you’re all sitting, or getting placed, each of you has
probably made a remark that has prompted
a possible response from one of
the other speakers. And I’d like to offer
each of you an opportunity, if you want to take it,
to either explore further or maybe challenge something that one of your colleague
speakers here has provided. So let me start
with you, Duffy, and see if you had anything
you wanted to comment on.>>Douglas MacKay: I’ll
just comment just to clarify, this is a little off topic, but the third party
certifications, I don’t know if that
was clarified very well. You’ll see that some companies will carry a seal
on their product, whether it be a USP seal
or NSF seal, and I just want to clarify
that we’ve talked a lot about the regulations and FDA doing good
manufacturing inspections and testing products, but we know they have
limited resources. So what companies do to insure
to their consumers that there is someone
looking over their shoulder and checking, they invest
in these third party seals, where another organization
will come, do an inspection, and see if they meet
their standard, and put a seal on the bottle.
So one of the familiar ones you’ll see in advertising
is the USP seal. So I just wanted to clarify
what that means for people, so if someone is distrusting
to a company, you can feel confident that
there is an independent body looking over their shoulder,
doing an evaluation.>>Paul Coates: Okay. Laura, did you have anything
you wanted to comment on?>>Laura Harkness: [inaudible]>>James Hamblin: I guess going
off of the good/bad swing, too, of why we get
into that cycle. I think that there are a lot
of forces in social media too, that are pushing that way,
and politics as well. Obviously, we know we respond
to strong things, we respond to something
that is either a miracle cure, or that is causing cancer
in all of us. And the in-between is much,
much harder to communicate, and we know that’s where
most of the effects we’re dealing with are. So, yeah, if anyone has found
great ways to communicate, to get people interested
in the nuance, or to write
for mass audiences, and say this is going to be
sort of good for some of you, and sort of bad
for others of you. And have that be
the takeaway of a story, that’s really difficult
when you’re doing, like you know,
news you can use sort of stuff, which I don’t have
to do quite so much, but other people who work
in health information –>>Paul Coates: Yeah.>>James Hamblin: — yeah,
that’s the constant challenge.>>Paul Coates: I think that’s
a challenge that we face in trying to help people
to understand that the balance of information, and not get too swayed
by one set of data or another, both of which
might have been based on the same original dataset, by the way, just exquisitely
massaged in very different ways. Todd?>>Tod Cooperman: I don’t have
a comment on anything said by the others,
just one general point, just in terms
of interpreting results. Because we do that,
at ConsumerLab, we’re poring over the latest
studies regarding supplements, and I think, it’s a shame, I think that many
in the medical community have come to see
vitamins as drugs. And so, you know,
it’s like I can almost predict every vitamin D study
I see that comes out, you know, if you’re
giving it to people who already have
a blood level of over about 20 nanograms
per deciliter, it’s not going to do much. And then the study’s
going to come out and say “vitamin D doesn’t work,”
you know. And then they give it
to people in England, you know, who get no sun,
and they have a level of 15, and it’s curing asthma
and respiratory conditions. So, it would be nice to see
more thought to those issues, because it makes it
very difficult for us. There was a study
that came out this week, or last week,
the one showing that folic acid actually reduces
the risk of stroke. However, when you look
deeply into that one, you know, it was based
on the study in China, where they don’t fortify
with folic acid, so it helps in China, and it doesn’t necessarily
always help here. So, you know, those are the kinds
of things you wrestle with, I’m sure, as a journalist
and we all have to wrestle with.>>Paul Coates: Yeah, thanks
for that observation. Laura, did you have anything
that you wanted to comment on?>>Laura MacCleery: Also,
just to — I was winding up
to my big finish –>>Paul Coates: Ah, sorry.
[laughs]>>Laura MacCleery:
That’s fine, it’s fine. [laughs]. So, I do think there are
particular things that we should do better
to figure out how to get away
from an addiction to man-bites-dog
clickbait, right? We need to bring greater levels
of skepticism to headlines, and news coverage. Because a lot of health
coverage, not The Atlantic, but other sources, are driven
by the unexpected finding, the surprise contrarian
view, et cetera. That’s what makes
the structure of news, and it’s very tempting, but it means that people
are confused on the whole, that there is a lot of noise
in the marketplace that’s open to exploitation. And it does have concrete
health consequences, because the manufacturing
and the branding of foods is then able to lock
into this pre-existing kind
of psychological landscape where we’re capable
of being misled. And so, I think better
science education, and really a discussion
about ethical norms in science or in medicine,
you know, is timely. Ethics conversations
among journalists about how do you provide
the necessary context, even in the landscape
that might be sort of boring in this sort
of news environment. Disclosure of funding
and of other sources of bias when research is conducted, and making it searchable
and sortable so that you know
at a glance from the abstract
of the study online, who was the funder, what was
the entanglements there. And then, just more public
education about skepticism and deeper grounding
in sort of scientific norms. That seems to me,
really important. You know, my daughter
is going to grow up in an environment that’s
even noisier than this one. And we need to start talking
about these things now, because we need to be able to
continue to publish complicated, nuance stories that say seven
out of eight of these studies were robust enough
to make a concrete finding, and they found no effect. And we need to have
a population of people who can receive that kind of
information and understand what it means in context.>>Paul Coates: Good.
Thank you very much. Merle?>>Merle Zimmermann: Thank you
very much. So, what I hear
from my colleagues here is it’s essential for us all to
maintain this focus to detail, this commitment to being
as informative as possible, to avoiding anything that
people might find misleading. And all these things together
are a clear path we can look at, which will lead us to great
outcomes in the future I think. So, just wanted to offer
my appreciation for all of you here,
coming down to the event, for our organizers, getting us
all at the same table, getting us in
a conversation together, so, thank you very much.>>Paul Coates: So, let me
just see now if there are some comments
or questions that members
of the audience have.>>Male Speaker: Hi, yeah,
Dr. Hamblin, I see here that The Atlantic
is hosting an event in Chicago tomorrow called “A New Frontier:
Biosimilars And Cancer Care.” Can you comment on the role
of The Atlantic in supporting research
and dissemination of research to the public?>>James Hamblin: That
would probably be an Atlantic Live event. Oh, okay, yeah, so Live events
are something that is a journalistic bringing together
of doing live interviews. We don’t actually
support research.>>Male Speaker: You’re putting
everybody together to make the conversation
happen?>>James Hamblin: Yeah, yeah,
it’s sort of bringing together for live conversations
in the same way that might happen on a talk show
on PBS or on public radio. But it’s happening
in a live event, which is a growing area
of interest in journalism, I think, probably a reaction
to this like, click bait saturated market and people feeling like they’re
isolated in echo chambers, where we can actually
have people come together and sit down live. They’re pretty small events
but you get — Yeah, I mean,
100 stakeholders together to actually have a conversation
in person, which is cool. My role there
is usually moderating.>>Paul Coates: Sounds like a
dietary supplement research
practicum to me.>>James Hamblin: It
very much does. [laughs]>>Paul Coates: There was
a question at the back and then, Regan,
and then Joe.>>Regan Bailey: Hi, this is
a really great session and I always enjoy hearing
all of your points of view. I’ve heard some criticism
that the industry doesn’t do research studies, and then we’ve also
heard criticism that we have to be skeptical
of industry-funded research, so I’m just wondering
if there’s a way that we can have partnerships, or if you envision
any tips or tricks on how to make things work
better than they have been.>>Paul Coates: While you’re
thinking about it, I’m going to weigh in
on that one because partnerships do, of course, exist,
specifically over research. Example, the Vital Trial
that is currently being run from Brigham
and Women’s Hospital Multicenter clinical trial,
relied on companies to provide active ingredient
and placebo at no cost. So that’s a way of participating
in the research. It’s clear what the roles
and responsibilities are of the public and
the private sector component, but there’s an example
of a partnership. So that was my take on it. What else would you
like to offer?>>Laura Harkness: So,
I’ll comment because I spent part
of my career in academics, so I was on the receiving
end of funding and I’ve spent a good part
of my career in industry, funding clinical trials. And up front, I think it’s
really important for the funder to specify
with the person who’s actually
conducting the research, what are the rules
of the road. And in some cases, we’ve simply
given grants and said, “This is your money,
you do with it what you want,” and we have no involvement
whatsoever in the trial. In other cases where we had
a lot of knowledge in that particular area,
we would be co-authors with the person
who was conducting the research. But I think if you’re really
clear up front –>>Male Speaker: [affirmative]>>Laura Harkness: —
I think we can have really good clinical trials
that don’t have industry bias, and there is industry bias,
but there’s also academic bias, and I think we have
to all be really clear about what our expectations
are up front.>>Paul Coates: Other comments
on this particular question from members here?>>Laura MacCleery: I think’s
reasonable to both require proof of effectiveness
in actual scientific studies and also to require transparency around the funding
of the studies. I don’t see the conflict. You know, you can evaluate
the findings of the study and it’s robust and it’s
with adequate transparency, and you need
both things to happen.>>James Hamblin: I do know
there’s a lot of readers who will just
immediately write off something that’s
industry-funded, and it’s easy to write
in a tweet, you know. If there is some new study
that says sugar isn’t as bad as we thought, if Coke has it’s name
anywhere on that, no one will, it will be
immediately written off, and the newspaper will be seen
as a sucker for even publishing it. And I mean I’m not saying
that that’s bad, that we’ve swung that far
in that direction. But I think there can be
industry funded research that’s good, it’s just really
hard to communicate, “Okay there is this conflict, you should be aware
of the funding source, but also the methodology
looks pretty good,” so take that
for what you will.>>Male Speaker: [affirmative]>>Laura MacCleery: I just
would say those readers are applying like a plausibility
analysis, you know –>>James Hamblin: Yeah.>>Laura MacCleery: —
If it’s Coca-Cola and it’s a study
about the outcomes of sugar and it runs contrary to
everything that’s been found — [laughing]>>Laura MacCleery: — it’s not
an unreasonable conclusion.>>James Hamblin: No, sure.>>Laura MacCleery: Right.>>Tod Cooperman:
And I would just add, as someone mentioned earlier,
just seeing if a trial was registered
at clinicaltrials.gov, you know, is certainly a boost, even if it is industry
sponsored.>>Paul Coates: There comes
an obligation with submitting protocols
to clinicaltrials.gov, and that is that the data be
made available after the trial has been finished
in some reasonable lifetime.>>Douglas MacKay: I think
this is — [laughter] — it is a salient issue
because the landscape I’m seeing is that the government’s
not handing out significantly more and more
amounts of money in the future, or at least the near future. And we are going to be reliant,
if we want claims, we want substantiation
from claims, someone’s going to have
to pay for that evidence. And if you want the evidence to
be specific towards the product and how the product is made
and the product is formulated, there’s not a lot of people
jumping up and down to pay
for those studies, other than the person
who’s going to sell the product. And that’s why we have consort
guidelines and clinical trials. And that’s why we have
clinicaltrials.gov, so that we can put
this information out and it can be judged fairly. The challenge is, and it’s going
to take years is, everyone’s just suspicious, and like you said,
I think we’re in an environment where you connect
to industry funding and people just dismiss it, and that is such,
it’s a problem for everyone. It’s not just a problem
for industry, it’s a problem
for future researchers. It’s a problem for people who are supportive
of additional science and additional
scientific studies. And the companies
that we work with, they go to a lot of risk
a lot of times when they invest in studies because the principal
investigators, they’re not pushovers,
they’ll say, “I’ll take your money,
but I’m in control of the study, I’m in control
of what’s published.” You know.
>>Male Speaker: [affirmative]>>Douglas MacKay: There’s
a lot of checks and balances in that process.>>Paul Coates: Joe, you had
a comment, and then Howie.>>Joseph Betz: Yeah, James,
sorry to pick on you, but you’re the journalist
up there. So, having been subjected
to interviews on science papers in the past,
my general impression is that there’s quite
a lot driving journalism that’s based on press releases. University will put out
a press release, the journalist will interview
the principal investigator, perhaps some other interested
parties, stakeholders, what percentage
of the journalists actually go, read,
and understand the study? Not the abstract,
but the full study.>>James Hamblin: Yeah,
actually, there are so many new small VC-funded journalistic
sort of click websites which are trying
to do the truth, but are also asking
young journalists to write four posts
a day across something
they don’t know a lot about, so it’s really,
really common for them to quote a press release,
or just read the abstract. It is much more rare for someone
who can dig into the methodology and is given the time to. So, you know, to hire someone
who has the background to be able to do that and then to give them
the time to do that, and then to go also
interview people who are expert who had nothing
to do with this study. You know when you read all that,
that means the best answer is to support
that journalistic outlet. And that’s not just a plug
for The Atlantic, like, whatever one you like reading.
But that costs money to do, and it is the result
of all these people who thought they were going to
disrupt the journalism industry by having people just post
five posts a day, who then really watered down
the quality and sort of led to all the sorts of things
that you’re describing, so we need good journalism.>>Paul Coates: Any other
comments from people on the panel
about this issue. Howie?>>Howard Sesso: Yes, I have
a brief comment, a quick survey question,
and then another question. First of all, I think science
has changed dramatically over the last two decades
in the way that it’s presented. So if you look
at journal articles, for example, they’re shorter
and shorter, on average. In addition, there’s been a
proliferation of online journals that have really diluted
the talent pool, if you will, of papers
that are coming out and being peer-reviewed,
if at all. And a lot of those
do involve supplement studies. It’s very easy to kind of
grab data, do meta analyses, and kind of generate headlines,
if you will. And the news cycle
is much quicker, it used to be about a week,
now it’s about, barely 24 hours. And I think that in light
of the previous comments about conflict of interest, it’s a very easy way
for a lot of the work that a lot of people
are doing with good intentions without the transparency. The whole key is transparency
of process all the way through. That whatever
your funding source is, it is what it is,
you state it up front, and ideally if there is
industry support of a trial or analyses that are being done,
the whole key to me is that it needs
to be investigator-initiated. Without that, I think it really
kind of sullies the science. So that’s brief comment. Then my second one
is a quick survey. I’m not sure
if this was done yesterday because I wasn’t here,
but a quick show of hands, I’m going to pretend
we’re doing a mini-study, how many people here
have taken any supplement in the last four weeks? It doesn’t matter what,
or anything. So interestingly, if you look
at the table there, and this is not to highlight
specific participants in this mini-study, it was three and three,
if you had noticed. So we all carry
certain biases toward how we view dietary supplements. No matter what
your perspective is, I think the whole key is to try and be as agnostic
to that process as possible. A lot of us are taking them
in some capacity, and how we take them,
how we interpret it’s incredibly important.>>Paul Coates: Just
a minute –>>Howard Sesso: Sorry.>>Paul Coates: — you didn’t
answer your own question. [talking simultaneously] [laughter]>>Howard Sesso: When I hit 50
in a few years, then I might be rethinking
that question, so.>>Male Speaker: [laughing]>>Howard Sesso: But then,
back to a question. So you know, one thing that’s
been incredibly important to me is trying to figure out ways that we could be
a little bit more innovative in how we approach research
on all levels. It’s not just the big trials
that I’ve been involved in, but all levels of research and trying to create
more partnerships and continuity and consistency
with methodology, how the funding sources
might be, whether it’s NIH or industry
or other non-profits. I’d love to hear
from the panel, all of you in aggregate
in some way just about how we can maybe try
and change our approach toward research
of dietary supplements. To make it a little bit
more transparent, a little bit more reliable,
and also how we can ensure that we avoid what I always like
to call the Dr. Oz effect, where things get sensationalized
and marginalized, but yet still reach
a very large segment of the population that ends up
turning into misinformation.>>Tod Cooperman: Just, so one
thing is the importance of when a study is done
with a supplement, to know that the supplement
was actually analyzed to know what was really
in that supplement. It used to be that
you’d rarely see that. I know you’ve been putting
a lot of you know –>>Paul Coates:
A lot of emphasis.>>Tod Cooperman: — pressure
on investigators to do that, but I still see, there was a study
that came out just this week, with a probiotic had
an amazing impact, it was done down in Baltimore,
on people with mania, who had just been hospitalized. The rate of rehospitalization
was so low if they were given a probiotic
versus not giving a probiotic, it was just dramatic. But they didn’t
really characterize what was in the probiotic. I’ve written to
the investigators to find out what’s in the probiotic
but you’d think. And this got a lot of coverage
as well, this study, so that’s just one thing, just making sure we know
what was actually tested.>>Paul Coates: I think
in that regard, I’ll just jump in
for a second, Duffy. In that regard, ODS’s work
is not done yet then, if we keep pressing to ensure
that quality research is done and well-characterized
products.>>Douglas MacKay: And to build
on that idea, there is one provision
in the regulation for new ingredients that have
entered the market after 1994, you have to commit to FDA
a dossier within 75 that establishes
the ingredient is safe. This is nuanced, it’s the new
dietary ingredient notification, it’s a robust process that costs
half a million dollars if you have
a unique ingredient. One of the things we’re working
on is working with FDA to do some intellectual
property protection, so for those people
who choose to go through the new dietary
ingredient process, they get no objection for FDA, they get their new dietary
ingredient out on the market, they have some intellectual
property protection. So it motivates them to build
a scientific dossier on that specific well-
characterized ingredient, as opposed to
a commodity ingredient. Right now what’s happening
is big company does all the science,
ingredient gets out there, and then other companies
see success and they’ll sell a similar
ingredient and call it the same. And so what we need
is we need to reward that specificity
for science-based companies.>>Tod Cooperman: Yeah,
I would add, actually it was CBD, because you’re hearing
a lot of CBD now, which is why we tested it. So it is going to be approved
this year as a drug, CBD, and if the company didn’t feel
that there would be a reward for that, they wouldn’t
have done the research. Interestingly, just so you know,
the CBD that’s being approved, will be approved probably, you know has hundreds
of milligrams of CBD. The CBD oils
that you see out there typically have single digits,
maybe 10 mg, no evidence that that’s really
going to be effective. [talking simultaneously]>>Douglas MacKay:
To clarify though, we’re not
talking about supplements –>>Male Speaker: No, no.>>Douglas MacKay: —
just for the record.>>Tod Cooperman: My
understanding is because CBD is actually under an IND, it’s being investigated
as a drug and can’t be sold
as a supplement, which is a weird rule,
but in any event, that’s I believe
where things stand.>>Merle Zimmerman: Well
I believe any, there are details to the new
dietary ingredient process with relation to INDs. But to try to stay
on the subject of ways to do better studies,
and ways to excel, I think events like this
where you can get together with folks who have conducted
exemplary studies, where we have opportunities
to socialize and engage with each other
during breaks, and to meet with people who have
different points of view are a really valuable part
of being able to take research
to the next level. Are there other questions
from the audience? Naresh?>>Naresh Chand: The food
allergy is very common, and same may hold true
for dietary supplements as well. I don’t think anybody
talked about it at all, idiosyncratic reactions
are very common, I think our colleague
mentioned about it. Any ideas, any thought about it,
any suggestions?>>Douglas MacKay: Did you say
food allergy?>>Male Speaker: [affirmative]>>Naresh Chand: Yes, food allergies and dietary supplement allergies.>>Douglas MacKay: So the same
regulations apply to dietary supplements to food.
We have to comply with FALCPA, the Federal Allergen Labeling
Consumer Protection Act. So we have to label
the eight major allergens plus we have
to be compliant with the gluten-free
labeling regulations and then soon,
the bioengineering. So, we’re on the same page
with all other food. If you have issues
with how food allergies are addressed
in the United States, you have to address it from all the commodity
categories together. I don’t know if that hits
[inaudible].>>Paul Coates: Merle?>>Merle Zimmermann: So,
if I could also jump in on that one,
with respect to allergens, I think we have a wonderful
opportunity here with a journalist, to remind consumers that
dietary supplements are foods. Foods occasionally have
these idiosyncratic reactions, so maybe look at some
of the recommendations we heard yesterday
with adverse events also today, possibly discontinuing use, talking to someone
with expertise, might be a good reminder to occasionally put in front
of the public.>>Paul Coates: Mary?>>Mary Hardy: So, as someone
who has looked at a lot of adverse
event reports, and I sense that you’re not
just asking me about food allergies
like peanuts, wheat, corn, soy, I forget
what the other ones are. Anyway, so the most often that this has shown up
in the literature again is adverse event reports,
and it’s reported generally as a cross-reactivity
in the Compositae family. So if you’re allergic
to anything that looks like a daisy, say you’re allergic
to chamomile, don’t eat a Ricola mint, because there are things
in there that might cross-react. There’s, theoretically,
you could cross-react, for example,
with Echinacea, et cetera. But it really hasn’t been
a large part of the adverse event reporting, the idiosyncratic allergic
events particularly. Just that one thing
in the Compositae family with cross-reactivity,
and that’s very uncommon, and the reactions are generally
not life threatening, like tree allergies are –>> Paul Coates: Okay
that’s helpful.>>Mary Hardy: —
Tree nut allergies are.>>Paul Coates: So, I’m going
to close this out now. I think this has been a vibrant
and useful discussion. I want to do two things, and the first is to thank
our panel members once again, especially for their tolerance
and their enthusiasm, and their willingness
to address questions from one another
and from the audience, so please join me
in thanking them. [applause]