Conflicts of interest, whats good for the goose…

28 Jul

As recently blogged by Autism News Beat, CBS Evening News (an American news outlet) recently performed an investigation into ‘how independent are vaccine defenders’? Something of an exercise in futility, it concluded that:

Ideally, it [vaccines] makes for a healthier society. But critics worry that industry ties could impact the advice given to the public about all those vaccines.

So, CBS say that the vaccine schedule makes for a healthier society but that the advice given about vaccines could impact the advice given.

Uh…so? Lets go through that again. It makes for a healthier society. Would CBS rather it didn’t? Bizarre.

Specifically, they attack the AAP, the Every Child By Two website and Paul Offit. The AAP has conferences funded by vaccine manufacturers, ECBT takes money from the vaccines industry….in fact, hold on…CBS say in their report (assume breathless excitement reporter voice)

Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too…

Oh do they? They admit it do they? Under the rigour of your intrepid journalism no doubt? Except that information is clearly available for all on their website. I do wonder if anyone from CBS even spoke to ECBT.

And of course there is Paul Offit – the official poster boo-boy for anti-vaccinationists everywhere. The man who dares to make a profit from his inventions! CBS took him to task for holding a patent on a vaccine. Shall we look at another man who made a patent application for a vaccine? That’s right – Andrew Wakefield. Except, unlike Dr Offit, who made no attempt to hide his association with the vaccine he was responsible for, Andrew Wakefield’s solicitors said that ‘Dr Wakefield did not plan a rival vaccine’.

How about other people who make a tidy income from the anti-vaccine industry? The Geier’s maybe who invented their own IRB to make sure that their ‘science’ was unhindered by ethical considerations…..or maybe Dr. Jay Gordon who thinks that the Polio vaccine could be replaced by simply not eating cheese. How much do you charge your clients Dr Jay? How about Laura Hewitson who’s husband works for the Wakefield owned Thoughtful House and who seems to be part of the Autism Omnibus hearings….how independent can her science be? How about the ARI/DAN group who are led by people who clearly have no clue at all as to the medical science they are making a large profit on. How much do each of these people make? How about Rashid Buttar who lists non-existent memberships on his CV and who charges upwards of $800 for a 1 hour consultation fee and who’s ex-patients report being out of pocket by about $20,000 in about a year.

Its up to you Dear Reader – are these things we should be worried about? Are these things CBS should be worried about? Are these conflicts of interest? Does the act of making any sort of money either from treating people or from existing business interests mean you cannot and should not talk about these things? Should we assume that only certain people have an agenda?

In my humble opinion, it should only become an issue when attempts are made to hide these things. Or deny them when they are clearly true. That cannot be said of the AAP, ECBT or Paul Offit. Maybe CBS should be asking to see the balance sheets of DAN doctors or vaccine litigation specialists. What have they got to hide? Maybe CBS should be inspecting the credentials of people who claim to be able to cure autism and reverse old age. Maybe CBS should be looking at the disturbing increase in ties between autism/anti-vaccinationists and scientology.

But I would think in the meantime that CBS will take the easy route of producing crap that informs no one about anything. Lets hope it doesn’t turn around and bite them on the arse eh?

Elsewhere
Orac weighs in too.

27 Responses to “Conflicts of interest, whats good for the goose…”

  1. isles July 28, 2008 at 15:49 #

    Attkisson’s reporting does not impress. I’d be more inclined to consider what she did journalism if there were any sign that she’d done more than listen to some mercury mommy frothing at the mouth and assign an intern to google for dollars.

  2. Ringside Seat July 28, 2008 at 19:44 #

    Yeah, this lady is just working the old lazy circuit. She’s like Olmsted: she’ll do her little series of spoonfed falsehoods, that require next to no thinking or labor, and then she’ll get fired.

  3. 4N6 July 28, 2008 at 21:45 #

    I would like to see some critically thinking newscasters, do an investigation into the sources of David Kirby’s income. Cliff Shoemaker, who is getting wealthier all the time off of his vaccine practice, has close relationships with the Polings, with the Geiers, with the lawyers in the autism vaccine omnibus. It is difficult to see a visible means of income for Kirby, that alone should set off alarm bells. It would be interesting to know how much time Atkisson spent talking to Kirby in preparing that ridiculous report. I’d like to know what Jay Gordon’s annual income is, too.

  4. Schwartz July 29, 2008 at 06:53 #

    Kev,

    Dr. Offit did hide some of his conflicts of interest when he sat on the vaccine recommendations committee and he directly violated the COI guidelines at the time.

    Although I’m sure COI exists in many instances, but why are you using that logic to justify the likes of Dr. Offit’s behaviour? Additionally, the amount of money involved in CDC vaccine schedule recommendations dwarfs the money involved for people like the Geiers. Sounds like a pretty lopsided comparison. I don’t see them setting national policy on anything.

    I am also surprised you’re not concerned about declared conflicts of interest. There is plenty of peer-reviewed evidence that illustrates that conflict of interest in medical studies leads to biased conclusions regardless of whether it is declared or not.

  5. Kev July 29, 2008 at 08:29 #

    What I’m trying to say Schwartz is that we’re _all_ conflicted. You, me, Paul Offit, Mark Blaxill, etc etc.

    I don’t think personally, the amount matters. Its the attempt to mislead (intentionally or not) which matters. I don’t know much about the COI or how that situation came about so a link would be appreciated.

  6. Schwartz July 30, 2008 at 01:54 #

    Kev,

    The Paul Offit COI is documented in the “Conflicts of Interest in Vaccine Policy Making, Majority Staff Report Committee on Government Reform U.S. House of Representatives June 15, 2000”

    In section V,C, 1 ACIP Members Do Not Fully Disclose Conflicts of Interest

    c) Dr. Offit
    “Dr. Offit lists that he is a consultant to Merck on an attachment to his OGE 450, but does not disclose whether or not he received any remuneration for his services. (Exhibit 39)”

    This is just one of several entries where his name appears in this document.

    Interestingly, he voted to include the Rotavirus vaccine in the schedule but recused himself when they voted to rescind the recommendation. This clearly shows where his conflict of interest priorities lie.

    I fully agree that everyone is biased, but I do not agree that everyone is conflicted. Conflict of interest is a well defined issue, and in many industries and governments, laws and regulations have been put into place to deal with them. Conflicts of interest usually deal with financial conflicts.

    If you want to say that everyone is conflicted, then you are redefining the conventional use of the statement and that doesn’t apply to the reporter who is using the standard terms.

    Complaining that her reporting is biased is not really logical. Your arguments against her reporting are not logical because:
    1) Arguing that other people do bad things is a falacious argument
    2) Her reporting wasn’t really that biased because the people she targeted influence Governmental organization and recommendations. The examples you gave do not. That alone makes it worth reporting about.
    3) The amounts of money involved in this group of individuals dwarfs the amounts of the others you listed. These individuals are directly (and individually in several cases) involved determining government and insurance policy which will affect their personal financial interests and that of their sponsors.

    Here is a small sampling of peer reviewed evidence that shows that even declared conflicts of interest affect the conclusions of peer-reviewed scientific studies.

    Financial ties and concordance between results and conclusions in meta-analyses: retrospective cohort study
    “Conclusion Meta-analyses on antihypertensive drugs and with financial ties to one drug company are not associated with favourable results but are associated with favourable conclusions.”

    “Drug Company Payments to Doctors Often Exceed Recommended Limits; Data Widely Unavailable to the Public”

    “Pharmaceutical Company Payments to Physicians”

    “Conclusions The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed. However, substantial numbers of payments of $100 or more were made to physicians by pharmaceutical companies.”

    “Ghost Authorship in Industry-Initiated Randomised Trials”

    “We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes . Its prevalence could be considerably reduced if existing guidelines were followed; in particular, journals should list the contributions of all authors . In addition, journals could ask for the name and affiliation of the statistician who analysed the data, if this information is not clear.”

    “The association between funding by commercial interests and study outcome in randomized controlled drug trials”

    “Conclusion: An association was found between the source of study support and the published outcome. Though the reason for this association cannot be determined from the data collected, future studies may clarify the importance of this finding for readers concerned with the relationship of funding bodies to the publication of research outcomes.”

    “An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia”

    “CONCLUSIONS: While the retrospective design of the study limits the strength of the findings, the data suggest that industry bias may occur in randomized controlled trials in schizophrenia. There appears to be several sources by which bias may enter clinical research, including trial design, control of data analysis and multiplicity/redundancy of trials.”

    “Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry”

    “… In sum, our results suggest that financial conflict of interest is at least as prevalent in psychiatry as in other specialties in medicine. Industry sponsorship and author conflict of interest are prevalent and do appear to affect study outcomes.”

    “Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?”

    “CONCLUSIONS: Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.”

    This is exactly why conflict of interest guidelines and rules exist because it is known to bias individuals. Why professional medicine and science thinks it is immune from this is beyond me.

  7. Ringside Seat July 30, 2008 at 18:17 #

    I have to say that, if accurate, I’m surprised by quite how strongly Dr Offit is supported by Merck. This doesn’t seem to be merely advisory work, or one-off involvements, but, if accurate, his academic and research position is sponsored by the company.

    He could reasonably be taken to potentially expect direct financial advantage from his public standpoints.

    Thus, I can’t see how his short designation isn’t most conventiently “The Merck-sponsored professor of pediatrics at…”

  8. Kev July 30, 2008 at 20:47 #

    Schwartz, I’m not saying that conflicts don’t exist but I do disagree with you that just because its gvmt led it matters. I think it _all_ matters. I really do. Amounts of money don’t matter to me, what matters is that people are honest about _where_ their money comes from.

    Of _course_ her reporting is biased, she only reports on one side of a story. Thats the very definition of bias (in real world terms) but I don’t mind that. I just don’t think stories about bias or conflict are really particularly interesting unless they cover _everything_ .

    I’ll read the COI thing you talk about tonight.

  9. isles July 31, 2008 at 14:31 #

    Schwartz, just…STFU.

    Interestingly, he voted to include the Rotavirus vaccine in the schedule but recused himself when they voted to rescind the recommendation. This clearly shows where his conflict of interest priorities lie.

    This was the first rotavirus vaccine, Rotashield, which was a competitor to the one Offit and colleagues were developing. He voted to allow a competing product to enter the market first, giving it the opportunity to become established and creating the potential for his own product to be shut out.

    Then when there was a safety issue with Rotashield, he recused himself, electing not to take part in kicking a competitor out of the market.

    This helped him how?

    If you don’t have something real to say, find something different to do.

  10. Schwartz July 31, 2008 at 17:59 #

    Isles,

    Still incapable of holding a civil debate I see.

    I’m not sure why, but you’re inferring that only one variant of a specific vaccine gets approved for use in the US or Canada. I suggest you review the FDA, or Health Canada documents that clearly outline multiple approved vaccines for individual diseases. (ex: there are multiple variants of dtap, flu vaccine by different manufacturers, etc)

    Once a vaccine for a disease meets the criteria for being added to the recommended list, it is much easier for similar vaccines to get included once they are approved by the FDA because the cost/benefit justification and analysis has already been
    done. If the competing product has realted efficacy, safety and cost profiles then there are far less barriers to have it included in the schedule. The first product to market had to work a lot harder to justify inclusion in the regular schedule.

    Having a Rotavirus vaccine accepted as being beneficial for the schedule certainly benefits subsequent rotavirus vaccines so he and his sponsor stood to gain from that decision.

    Having a Rotavirus vaccine subsequently removed from the recommended list due to safety issues is guaranteed to make future rotavirus vaccines harder to approve and certainly more costly to approve due to increased scrutiny — which is what happened. Hence, the decision to remove the vaccine would negatively affect Dr. Offit’s financial interests.

    Along the same lines, any general issue around the vaccination schedule, or vaccination in general, can easily affect people’s confidence in all vaccines and that would have a negative impact on his financial interests. So his constant dismissal of any possible vaccine issues (regardless of the vaccine or combination) is also consist with his own financial interests.

    So to summarize:

    1) Adding a Rotavirus vaccine to the recommended schedule benefits Dr. Offit’s financial interests –> he votes yes.

    2) Removing the rotavirus vaccine from the recommended schedule hurts Dr. Offit’s financial interests –> he recuses himself.

    Conclusion #1: He votes in line with his financial interests and declines to vote against his financial interests.

    Conclusion #2: He is more concerned with perceived Corporate conflicts, than he is with safety.

    You conveniently brushed aside the fact that he violated the regulations. You also didn’t address the peer-reviewed studies that show financial conflicts of interest affect study conclusions.

    Isles, you might be better off going back to trolling the newpaper boards.

  11. isles July 31, 2008 at 22:27 #

    (1) 70,000 study participants and Rotateq had an easier time than Rotashield?

    (2) Show where Offit violated any regulation. Go ahead and try.

  12. Schwartz August 1, 2008 at 01:49 #

    Isles,

    Please read the “Conflicts of Interest in Vaccine Policy Making, Majority Staff Report Committee on Government Reform U.S. House of Representatives June 15, 2000” section V,C, 1 ACIP Members Do Not Fully Disclose Conflicts of Interest, part c).

    Paul Offit did not fully disclose his conflicts of interest.

    “Members must report specific sources of earned income over $200 for the filer and $1,000 for the filer’s spouse. ACIP members must report all honoraria received in excess of $200, along with the date services were provided. The $1,000 threshold for spousal earned income does not apply to honoraria, because of special concerns about that form of income.[lxi] They must also report all assets held for investment or the production of income with a fair market value greater than $1,000 at the end of the reporting period. The filer does not have to report the dollar amount or values for any asset or income.[lxii]”

    Thank you for confirming my second point. To re-iterate what I said above: “Having a Rotavirus vaccine subsequently removed from the recommended list due to safety issues is guaranteed to make future rotavirus vaccines harder to approve and certainly more costly to approve due to increased scrutiny—which is what happened. Hence, the decision to remove the vaccine would negatively affect Dr. Offit’s financial interests.”

    As I described earlier, by finding issues in the first vaccine and rescinding the recommendation made it a lot harder for Rotateq (the 70,000 child study) to get approved and recommended. And Dr. Offit recused himself on the vote for the rescinding of Rotashield.

    Thanks for adding more evidence to support my position.

  13. Sullivan August 1, 2008 at 02:11 #

    Sorry Schwartz,

    you are spinning, plain and simple, and it isn’t working.

    Voting for Rotashield was a good example of Dr. Offit acting against his own financial and professional interests. He was putting a competitor’s vaccine into the schedule.

    Abstaining from the vote on removing it from the schedule, again, was the appropriate thing to do.

    As to the, “thanks for adding more evidence..” type of comments–I don’t see how promoting that sort of image for yourself helps your discussion. It really doesn’t reflect well upon you.

  14. isles August 1, 2008 at 02:31 #

    I’m sorry, Schwartz, did you seriously just try to refer to the blatherings of a corrupt politician and his SafeMinds ghostwriters as an authoritative document? I have more faith in the National Enquirer.

    Nice try, for you I guess…

  15. Dawn August 1, 2008 at 11:50 #

    Schwartz/Isles: I have a question – according to items I have read, Dr Offit does not profit from the rotavirus vaccine as the proceeds go to non-profit organizations. So, if a person does not personally benefit financially, is it a conflict of interest? I think the non-profits DO benefit the university and hospital he works for, but am not sure.

  16. isles August 1, 2008 at 13:46 #

    I think the potential for one’s institution to benefit would not be much of a motivation for one to make statements that put one’s professional credibility on the line.

  17. Schwartz August 1, 2008 at 14:32 #

    Sorry Sullivan but nice try on your spin,

    1) An early vaccine for a new disease gets approved for use, but not recommended on the schedule
    2) the first company shows over time (by performing marketing trials) efficacy in financial objectives (reduced hospitalizations etc) using this data to justify inclusion in the recommended schedule
    3) Second company comes along providing a second source of manufacturing (important to the FDA) with similar efficacy and safety data
    4) It is a no brainer to allow that vaccine to also be included in the recommended schedule.

    This is simple logic and happens all the time. The data required to include the second vaccine in the schedule is far less onerous than the first unless there are problems with the first one.

    If the early vaccine gets subsequently removed from the schedule, there will be (and was) increased scrutiny on all vaccines of that class, and as such much more expensive for any vaccine of that type to be included in the schedule, hence the large study for Merck, and the significant post-deployment tracking requirements.

    No trickery here. Just simple economics and process.

    “As to the, “thanks for adding more evidence..” type of comments—I don’t see how promoting that sort of image for yourself helps your discussion. It really doesn’t reflect well upon you.”

    I guess the blatent hypocracy of pointing out a relatively polite response while ignoring direct personal attacks from Isles reflects well on you? Why don’t you worry about your own objectivity first?

  18. Schwartz August 1, 2008 at 14:51 #

    Isles,

    The last time I looked up the definition of bi-partisan committee it consisted of more than one person. Of course sweeping unsubstantiated generalizations are exactly the type of false arguments you have a history of giving. This is even more ironic since the report is quite detailed and specific in it’s accusations. Of course, you present no evidence to contradict it.

    I’ll stop wasting my time until you have something concrete to discuss.

  19. isles August 1, 2008 at 14:51 #

    You don’t get it, do you, Schwartz? The first vaccine out of the box is what doctors start using. The second one to hit the market has to convince them to change their habits. That is the situation that approving Rotashield set up for RotaTeq.

    Your incorrect assertions are not welcome just because you think you’re being diplomatic in delivering them.

  20. Schwartz August 1, 2008 at 15:07 #

    Isles,

    Do you think that patients come in and demand MMRII from merck? How about the branded flu vaccine from Chiron? How about the DTAP variants? Do you even know how many are available in the US and Canada?

    In a lot of cases with recommended vaccines in the schedule, bulk orders get put in by large organizations (government, HMO’s, hospitals), and they don’t base their purchase decision on who was first to market. They base it on availability, and cost.

    The FDA is trying to encourage more vaccine development, not less. Why would they design a system that provides a dis-incentive for multiple product offerings? The opposite is true. They are trying to promote vaccine development, not guarantee monopoly to the first past the post.

  21. Schwartz August 1, 2008 at 15:20 #

    Dawn,

    Merck’s Rotateq vaccine is not a non-profit vaccine and is contained in Merck’s quarterly sales numbers if you read their financial results. Last year, it was at 171M a quarter, which means it was nearing the coveted billion dollar a year mark.

    I believe you were likely reading about Merck working with PATH who is a non-profit organization. They are jointly running clinical trials in Africa. This type of marketing data, will then be used to justify the mass deployment of the vaccine to third world countries.

    The North American and European sales will continue to produce generous profits for Merck.

    WRT to Dr. Offit, he was (and probably still is) working as a consultant for Merck which means he certainly stands to gain financially from the financial benefits of his sponsor.

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