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Mark Blaxill on Industry Corruption of Scientific Journals: Is Something Rotten in Denmark?

Scientific integrity By Mark Blaxill

Several years ago, at the invitation of a journal editor interested in the issue of industry corruption of scientific journals, I drafted an article on the Denmark epidemiology studies. I had just published a couple of articles on autism in other journals and was interested in making additional contributions. I was outraged that the sponsorship of the Danish publications had been spearheaded by the company that manufactured the thimerosal-containing vaccines investigated for their connection to autism and astonished that this connection had received no attention whatsoever. I did a simple analysis of the social network of authorship to show that a single collaboration was behind the entire publication program, wrote up the results and sent a first draft back to the journal.

The peer reviews that came back were constructive and helpful, but also argued for some pretty extensive revisions. The changes had little to do with the conflict of interest argument and mostly involved relatively arcane issues of network analysis and asked me to explain some of the technical choices I had made and how the results of these technical choices should be interpreted. When I got the feedback, I was quite busy on other projects and had begun losing my enthusiasm for running the publication gauntlet at academic journals. As a result, I gave up on the effort and never responded to the suggestions.

As the scandal involving Poul Thorsen’s misrepresentation of his employment and possible misappropriation of funds, it seemed to me that this analysis took on new relevance. So we have decided to run my original draft here in its entirety. We hope that you’ll read it understanding its original intent and in a spirit of forgiveness for its shortcomings.

IS SOMETHING ROTTEN IN DENMARK? A SOCIAL NETWORK ANALYSIS OF CONFLICT OF INTEREST IN VACCINE SAFETY RESEARCH

Mark F. Blaxill, M.B.A.
Vice President, SafeMinds

Short title: Commercial conflicts in vaccine safety research
 
ABSTRACT

Three papers based on a Danish patient registry argued against a link between mercury-containing vaccines and autism. Following a related analysis of the autism-MMR vaccine link, these studies were published in close succession in prestigious journals, based on marginally differentiated analyses of the same events and prepared by author groups with numerous connections.

Analysis of these publications, their authors and sponsoring institutions reveals a social network with extensive personal and institutional ties. Analysis of the authors and their employers also reveals a pervasive conflict of interest that was not reported in the publishing journals.

All authors in the network have ties, direct or indirect, to a for-profit, state-owned, vaccine manufacturer: the Statens Serum Institut (SSI).  The mercury-containing vaccine investigated in the three studies was produced by SSI. Six SSI employees participated as co-authors in studies in which the safety of SSI products were evaluated. These six individuals also hold central positions in a broader network with ties to eleven additional authors and maintain formal alliances at the institutional level.

SSI has a commercial interest in vaccine products: the vaccine division contributed half of SSI’s revenues and over 80% of profits in 2002; vaccine exports were SSI’s fastest growing business; mercury-containing vaccine products support SSI’s vaccine exports; and SSI provides ingredients for mercury-containing vaccines currently used outside Denmark.

SSI has a conflict of interest in conducting assessments of vaccine safety. This conflict should be considered when evaluating the authors’ findings that mercury in Danish vaccines did not cause harm.

Key words: Vaccines, mercury, autism, thimerosal, social network analysis, conflict of interest.

Read the full paper in .pdf form Is Something Rotten in Denmark
See the figures in .pdf form HERE.

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You need to address the corruption that created the Federal Reserve before you can solve the problem with vaccines.

CONFICT OF INTEREST

CONGRESSMAN DAN BURTON'S OPENING STATEMENT FOR THE CONGRESSIONAL COMITTEE PROBE INTO CONFICTS OF INTEREST IN THE CDC-FDA ADVISORY COMMITTEES 15 June 2000
inbox for thepaulshapiro@yahoo.com
From: NANCALE@aol.com (E-M this address and get on the E-M distribution list)
Date: Fri, 16 Jun 2000 20:25:51 EDT
Subject: Congressman Burton's Opening Statement
Some of the hearing testimony is already up on Congressman Burton's web site..
http://www.house.gov/reform/hearings/healthcare/00.06.15/index.htm
Below is Congressman Burton's Opening Statement Opening Statement
Chairman Dan Burton, Committee on Government Reform
“FACA: Conflicts of Interest and Vaccine Development: Preserving the Integrity of the Process”
Thursday, June 15, 2000, 1:00 pm , 2154 Rayburn House Office Building Washington, DC 20515

Today, we are going to continue our series of hearings on vaccine policy. For the last few months, we’ve been focusing on two important advisory committee and the Centers for Disease Control and Prevention (CDC) rely on these advisory committees to help them make vaccine policies that affect every child in this country. We’ve looked very carefully at conflicts of interest. We’ve taken a good hard look at whether the pharmaceutical industry has too much influence over these committees. From the evidence we found, I think they do.

The first committee is the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This Committee makes recommendations on whether new vaccines should be licensed. The second committee is the CDC’s Advisory Committee on Immunizations Practices (ACIP). This committee recommends which vaccines should be included on the Childhood Immunization Schedule.

To make these issues easier to understand, we’re going to focus on one issue handled by these two committees – the Rotavirus vaccine. It was approved for use by the FDA in August 1998. It was recommended for universal use by the CDC in March 1999. Serious problems cropped up shortly after it was introduced. Children started developing serious bowel obstructions. The vaccine was pulled from the U.S. market in October
1999. So the question is, was there evidence to indicate that the vaccine was not safe and if so, why was it licensed in the first place? How good a job did the advisory committees do? We’ve reviewed the minutes of the meetings. At the FDA’s committee, there were discussions about adverse events. They were aware of potential problems. Five children out of 10,000 developed bowel obstructions. There were also concerns about children failing to thrive and developing high fevers, which as we know from other vaccine hearings, can lead to brain injury. Even with all of these concerns, the committee voted unanimously to approve it.

At the CDC’s committee, there was a lot of discussion about whether the benefits of the vaccine really justified the costs. Even though the cost-benefit ratio was questioned, the Committee voted unanimously to approve it. Were they vigilant enough? Were they influenced by the pharmaceutical industry? Was there appropriate balance of expertise and perspectives on vaccine issues? We’ve been reviewing their financial disclosure statements. We’ve interviewed staff from the FDA and the CDC. The staff has prepared a staff report summarizing what we’ve found. At the end of my statement, I’ll ask unanimous consent to enter this report into the record. We’ve identified a number of problems that need to be brought to light and discussed.

Families need to have confidence that the vaccines that their children take are safe, effective, and truly necessary. Doctors need to feel confident that when the FDA licenses a drug, that it is really safe, and that the pharmaceutical industry has not influenced the decision-making process. Doctors place trust in the FDA and assume that if the FDA has licensed a drug, it’s safe to use. Has that trust been violated? How confident in the safety and need for specific vaccines would doctors and parents be if they learned the following:
1 That members, including the Chair, of the FDA and CDC advisory committees who make these decisions own stock in drug companies that make vaccines.
2. That individuals on both advisory committees own patents for vaccines under consideration or affected by the decisions of the committee.
3 That three out of five of the members of the FDA’s advisory committee who voted for the rotavirus vaccine had conflicts of interest that were waived.
4. That seven individuals of the 15 member FDA advisory committee were not present at the meeting, two others were excluded from the vote, and the remaining five were joined by five temporary voting members who all voted to license the product.
5. That the CDC grants conflict-of-interest waivers to every member of their advisory committee a year at a time, and allows full
participation in the discussions leading up to a vote by every member, whether they have a financial stake in the decision or not.
6. That the CDC’s advisory committee has no public members – no parents have a vote in whether or not a vaccine belongs on the childhood immunization schedule. The FDA’s committee only has one public member.

These are just a few of the problems we found. Specific examples of this include: Dr. John Modlin— He served for four years on the CDC advisory committee and became the Chair in February 1998. He participated in the FDA’s committee as well owned stock in Merck, one of the largest manufacturers of vaccines, valued at $26,000. He also serves on Merck’s Immunization Advisory Board. Dr. Modlin was the Chairman of the Rotavirus working group. He voted yes on eight different matters pertaining to the ACIP’s rotavirus statement, including recommending for routine use and for inclusion in the Vaccines for Children program. It was not until this past year, that Dr. Modlin decided to divest himself of his vaccine manufacturer stock.

At our April 6 autism hearing, Dr. Paul Offit disclosed that he holds a patent on a rotavirus vaccine and receives grant money from Merck to develop this vaccine. He also disclosed that he is paid by the pharmaceutical industry to travel around the country and teach doctors that vaccines are safe. Dr. Offit is a member of the CDC’s advisory committee and voted on three rotavirus issues – including making the recommendation of adding the rotavirus vaccine to the Vaccines for Children’s program.

Dr. Patricia Ferrieri, during her tenure as Chair of the FDA’s advisory committee, owned stock in Merck valued at $20,000 and was granted a full waiver.

Dr. Neal Halsey, who serves as a liaison member to the CDC committee on behalf of the American Association of Pediatrics, and as a consultant to the FDA’s committee, has extensive ties to the pharmaceutical industry, including having solicited and received start up funds from industry for his Vaccine Center. As a liaison member to the CDC committee, Dr. Halsey is there to represent the opinions of the organization he represents, but was found in the transcripts to be offering his personal opinion as well.

Dr. Harry Greenberg, who serves as Chair of the FDA committee, owns $120,000 of stock in Aviron, a vaccine manufacturer. He also is a paid member of the board of advisors of Chiron, another vaccine manufacturer and owns $40,000 of stock. This stock ownership was deemed not to be a conflict and a waiver was granted. To the FDA’s credit, he was excluded from the rotavirus discussion because he holds the patent on the rotashield vaccine.

How confident can we be in the process when we learned that most of the work of the CDC advisory committee is done in “working groups” that meet behind closed doors, out of the public eye? Members who can’t vote in the full committee because of conflicts of interest are allowed to work on the same issues in working groups, and there is no public scrutiny. I was appalled to learn that at least six of the ten individuals who
participated in the working group for the rotavirus vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines. How confident can we be in the recommendations with the Food and Drug Administration when the chairman and other individuals on their advisory committee own stock in major manufacturers of vaccines?

How confident can we be in a system when the agency seems to feel that the number of experts is so few that everyone has a conflict and thus waivers must be granted. It almost appears that there is a “old boys network” of vaccine advisors that rotate between the CDC and FDA – at times serving simultaneously. Some of these individuals serve for more than four years. We found one instance where an individual served for sixteen years continually on the CDC committee. With over 700,000 physicians in this country, how can one person be so indispensable that they stay on a committee for 11 years?

It is important to determine if the Department of Health and Human Services has become complacent in their implementation of the legal requirements on conflicts of interest and committee management. If the law is too loose, we need to change it. If the agencies aren’t doing their job, they need to be held accountable. That’s the purpose of this hearing, to try to determine what needs to be done.


Why is this review necessary? Vaccines are the only substances that a government agency mandates a United States citizen receive. State governments have the authority to mandate vaccines be given to children prior to admission to day care centers and schools. State governments rely on the recommendations of the CDC and the FDA to determine the type and schedule of vaccines.

I am not alone in my concern about the increasing influence of industry on medicine. Last year, the New England Journal of Medicine learned that 18 individuals who wrote drug therapy review articles had financial ties to the manufacturer of the drugs discussed. The Journal, which has the most stringent conflict of interest disclosures of medical journals, had a recent editorial discussing the increasing level of academic research funded by the industry. The editor stated, “What is at issue is not whether researchers can be 'bought' in the sense of a quid pro quo, it is that close and remunerative collaboration with a company naturally creates goodwill on the part of researchers and the hope that the largesse will continue. This attitude can subtly influence scientific judgment.”

Can the FDA and the CDC really believe that scientists are more immune to self-interest than other people? Maintaining the highest level of integrity over the entire spectrum of vaccine development and implementation is essential.

The Department of Health and Human Services has a responsibility to the American public to ensure the integrity of this process by working diligently to appoint individuals that are totally without financial ties to the vaccine industry to serve on these and all vaccine-related panels.
No individual who stands to gain financially from the decisions regarding vaccines that may be mandated for use should be participating in the discussion or policy making for vaccines. We have repeatedly heard in our hearings that vaccines are safe and needed to protect the public. If the panels that have made the decisions on all vaccines on the Childhood Immunization Schedule had as many conflicts as we found with rotavirus, then the entire process has been polluted and the public trust has been violated. I intend to find out if the individuals who have made these recommendations that effect every child in this country and around the world, stood to gain financially and professionally from the decisions of the committees they served on. The hearing record will remain open until June 28 for those who would like to submit a statement into the hearing record.

Mark, this is prescient. Goodbye to the CDC's assert that Poul Thorsen was a minor player: his name comes up tied for first place in three of the four measures of author centrality on these key studies. Good for you!

Complicit parties must be quaking in their boots. What else do you have on Masden and the CDC? Now is the time to go beyond the reticent academic conclusion that "Their work should be interpreted with caution" and get Kim to write a headline that nails
these m*****fu**ers! Can't thank you enough. But thanks!

With all of the dangerous drugs that have caused so many deaths and permanent health damages, and all of the so called "studies" which declare them "safe", I can't imagine any medical doctor not having a clue about the corruption in their own industry. True, the doctors are farther down on the ladder than the researchers and appointed "officials" at government agencies like the FDA and CDC, who are continually exposed with conflicts of interest and industry financial influence. Yes, it's the people at the "top" who are actively engaged in this conspiracy to achieve vaccine compliance at all costs, however for doctors to cart blanche ignore the evidence, especially with untold thousands of families telling the EXACT SAME STORY that their children developed autism as direct result of vaccines...WHOA, what's really going on here with the medical profession? None of these pediatricians who are supposed to be entrusted with our children's health care ever questioned this overloaded toxic vaccine schedule?

Considering the intelligence required to graduate from medical school, these doctors are either in total denial, or they just don't give a shit.

Gatagorra, you've precisely identified the hazards of social climbing within the realm of public health.

Have you ever overheard low-level state munchkins speaking reverently of the international luminaries? "Touch the robe," indeed. And those who play the political game do get rewarded, with appointments to committees like ACIP or positions with faux consumer groups supported by pharmaceutical companies.

Thank you, Mark, for sharing your comprehensive analysis of these interlinking self-interests -- a record which has proved to be quite prescient.

The financials on page 8 are quite telling: "The Vaccine Division exhibited the highest growth rate, with revenue increasing at over 11% per year" and "[T]he SSI’s export revenue was nearly 90% comprised of vaccine sales outside Denmark." What an incentive to nudge and fudge data.

Imagine the positive impact on public health if the mainstream media or the AAP actually cared to report and redress these dirty tricks of multiple publication or the failure to report conflicts of interest. Tragic that this aspect is lost in the current national healthcare debate.

Thank you, Mark. What was especially fascinating in reading this was the introduction to the science of human influence. I was particularly tickled by "Eigenvector centrality", the measure of the degree to which an individual authors has connections to other authors of high influence.

Imagine that "high influence" as a royal robe upon which others might step and be carried along, status wise, closer and closer to elite forces and spheres of influence. But that pretty quickly becomes guilt by association if the parties involved have overly flexible ethics. It's conceivable that someone innocent can be smeared in the arrangement, but in this case, none of the "central" parties were unconflicted. There was no mistaken "smearing".

You know the old German saying: Eigenvektor mit hunden and you get up mit flöhen.

In the case of the CDC, it appears to have been a dog kennel for a pretty long time.

Ana B,

I agree, but would add... there is an enormous financial incentive for pediatricians to lie to themselves. What do you suppose would happen to the annual income of pediatricians without all those vaccine-driven "well child" visits? And once we all stop bringing our children to the doctor for so many vaccines, we might start to wonder why we need to bring well children to the doctor at all.

Can't have that.

AnaB

The new explanation for "doing nothing" is coming to the conclusion, out of political necessity..the vaccine industry .. manufacturers, public health agencies, pediatricians, research universities, etc....is simply

TO BIG TO FAIL

I wish every pediatrician in America would read Age of Autism. All they get is what is handed down from them on high by the AAP in Chicago - the AAP, hardly a disinterested party on the vaccine issue. I always thought it interesting that of the studies most eggregious in their conflicts of interests, missing data, etc. etc. it is always Pediatrics who peer reviewed those particular studies, thus giving them legitimacy in the eyes of Pediatricians.

People often say to me, "you think it is some conspiracy where the government, medical journals,researchers all collude to brain damage children?" No, I don't think it works like that.

When the truth of something is so horrific, so much to bear - people, large groups of people even, lie to themselves. They'll even refuse to let new information if it is unsettling. And, when the issue concerned is something so established and ultimately life-saving like vaccines want to believe they are safe for all people, so this is what they choose to believe, telling themselves that parents, "just want something to blame".

Yes, I believe there are some at the top who know what is really happening to the kids. Perhaps they direct who does the studies and what hypothesises are raised? They may justify their actions by saying things like, "better to have some people harmed by vaccines than have diseases come back". Perhaps they use this on those in the medical community and the media? Fear is a powerful motivator: "raise the question and vaccine rates will plummet and diseases will come back." Nobody wants that on their shoulders, so they deny even the thought of harm happening from vaccines themselves.

So no, I don't don't believe it is a deliberate conspiracy to do harm....just a conspiracy by a few to cover up harm and mass denial to an inconvient truth by many in the medical field.

This was excellent several years ago and even more so now. Your investigations and analysis of these conflict of interest people, especially since Thorsen is currently gaining suspicion as a fugitive from ethical research, employment ...and compromised autism-thimerosal-ties-

"Further investigation of Thorsen, however, revealed an unexpected connection to the fifth institution, the CDC. Thorsen was listed as lead author in a 2002 publication in which his institutional affiliation was listed not as the University of Aarhus but as the CDC (30).
Thorsen’s CDC affiliation was undisclosed in his subsequent publications on autism and vaccines (14,17). Further inquiries have revealed that Thorsen holds a joint appointment at the University of Aarhus and the CDC where he is a “Principal Investigator on CDC projects on autism” (31).

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