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Offit's Failure To Disclose Financial Interests on Dateline Jeopardizes Swine Flu Vaccine

Assforsale[1] From NAA and making the rounds of several news release services today. 

(Austin, Texas) – As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer.  Dr. Paul Offit of Children’s Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vaccine patent to Merck, which is the manufacturer of MMR.  According to CHOP documents, Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.

“When Dr. Offit went on Dateline he was probably disinclined to criticize the MMR vaccine since it is produced by the same pharmaceutical company that made him a wealthy man,” said Jim Moody, attorney for the National Autism Association (NAA).  “If people are to have confidence in the integrity of the Swine Flu vaccination program this fall then we need full disclosure of all financial relationships between proponents and manufacturers on every vaccine on the market.  Who has an objective opinion about a company that has made them rich?” 

Dateline NBC’s broadcast was about the potential link between the MMR vaccine and the onset of autism.  Offit has stated unequivocally that there is no connection and that he has no conflict of interest with Merck.  However, he acknowledged in testimony to Congress in 2000 that “I have been in collaboration with Merck and Co. on the development of a rotavirus vaccine since 1992” and that “I am a consultant to Merck.”  Although the Rotateq vaccine that enriched Offit has no relationship to MMR, his close financial connections to Merck, if disclosed, are likely to affect the public’s value of his opinions on the efficacy of the MMR vaccine.

“It is, at a minimum, disingenuous of Dr. Offit not to tell the public through the Dateline program what he told Congress in 2000,” said Dr. Andrew Wakefield, Executive Director of Thoughtful House autism treatment center, who was also featured in the program.  “Even if he is no longer a consultant to Merck, the fact the company made him wealthy by buying his rotavirus vaccine is certain to make him warmly view the company and its products, including MMR.  Let us hope that all such relationships are disclosed prior to any Swine Flu vaccination program.”

Offit has frequently accused Wakefield of being conflicted during his MMR research, claiming that Wakefield was being paid by a law firm for his expertise on MMR while also conducting his studies.  Although physicians are frequently paid for their medical expertise in legal cases, Wakefield fully disclosed his relationship with the litigators in various UK media stories and publicly reported documents.  Offit, however, has continued to back MMR as completely safe while failing to inform the public that the MMR manufacturer Merck has made him so wealthy he said “it was just like winning the lottery.”  As a member of the Advisory Committee on Immunization Practice, Offit also voted to include the rotavirus vaccine in the Vaccines for Children program, which ultimately made his Rotateq product worth hundreds of millions of dollars to Merck. 

"Offit has zero credibility in matters of vaccine safety,” said Wendy Fournier, President of the NAA. “Not only does he advance the absurd suggestion that children could safety get 100,000 vaccines at a time, he opposes any studies of the comparative health of unvaccinated children that could shed light on the extent and nature of vaccine-caused injuries, leading to their prevention.  

Beyond Offit’s financial conflicts, autism advocates are also dismayed about the physician’s credibility on speaking about autism in general, as he does not treat patients with autism.  “It’s a mystery how such an inexperienced and financially conflicted man has become the go-to guy for information on autism,” commented Ms. Fournier.  “Here’s a man with no real knowledge about autism that again and again appears in media coverage.  Not only is he completely unqualified to address autism from a medical standpoint, his financial conflicts of interest disqualify him as a credible source for vaccine safety commentary as well.”


 

Comments

Theresa

For Tina, I'll bet you have no idea how many articles in your newspaper are barely-edited versions of press releases printed nearly verbatim by lazy copywriters and editors. (I used to work at a PR firm, so I know. It was pretty hilarious watching 90% of our press release make it into an "article" in a newspaper.) This particular press release is very clear about who is making the charges against Offit: the National Autism Association. Would you find it objectionable if AoA printed a press release from an autism charity group holding a fund-raiser? Print newspapesrs do that all the time.

For Albert, I'm a little confused. Are vaccines a competitor to Lee Silsby supplements?

Jake Crosby

Speaking of swine flu, here's a little bit of information about another old friend:

Edelman has created the Global Task Force on H1N1 Influenza to help its clients and partners navigate the communications challenges associated with the potential outbreak of H1N1 flu. The task force comprises a network of public health and crisis communications specialists, including former U.S. Centers for Disease Control and Prevention Director Dr. Julie Gerberding, who are ready to help organizations engage their internal and external stakeholders early and protect their reputations.
http://www.edelman.com/H1N1_flu/

Let me reiterate that last sentance:

"The task force comprises a network of public health and crisis communications specialists, including former U.S. Centers for Disease Control and Prevention Director DR. JULIE GERBERDING, who are ready to help organizations engage their internal and external stakeholders early and PROTECT THEIR REPUTATIONS."

Need I say more?

nhokkanen

Albert, other vitamin companies are welcome to spend their advertising dollars at AoA. As long as their supplements aren't filled with dyes, fillers, use bio-unavailable forms of cobalamin, co-opt children's cartoons, or otherwise suck.

Sarah

Albert,

and exactly how are Lee Silsby ads any worse than Pharma ads in "Pediatrics" or other medical publications, web sites or on the Nightly news?

Unlike Pharma, Lee Silsby is one of the companies that makes products has actually help autistic kids. Go Lee Silsby!

Josh

Albert... lol

Here's a lollipop. Now run along.

Paul Shapiro

Please be aware that Dr Paul Offit held the patent for the Rotavirus Vaccine
and receive a conflict of interest waiver from the FDA thereby enabling
him to become a member of the FDA oversight and approval committee
for this vaccine. About half of the members had financial interest in the
approval of the Rotavirus vaccine. The Rotavirus vaccine was approved
for children by this committee half of whose members had financial interest .
Apparently the approval of this vaccine was premature for in a short period
of time many children had severe stomach problems that required surgery
to clear. A least on child died as a result of having been injected with this
poison and the FDA removed the vaccine from the market. Paul Offit's
conflict of interest finger prints along with the rest of his cronies
were all over the premature approval and release to market of this vaccine.

I am a lay person so I can not give the details of the damage done to the
children that received the vaccine.

How ever I can provide backup for what I claimed about conflict 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.

Albert

And you forgot to mention how you advertise for Lee Silsby, a company that clearly benefits from your attacks on their competitors.

Teresa Conrick

I missed this from much earlier today....

http://www.pharmalive.com/News/index.cfm?articleid=649638&categoryid=10

Offit's Failure to Disclose Jeopardizes Swine Flu Vaccine Program
PharmaLive.com (press release) - ‎12 hours ago‎
AUSTIN, Texas, Sept. 8 /PRNewswire-USNewswire/ -- As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, ...

julie

I didn't think AoA was trying to hide the fact that this is a press release. It was clear to me from reading the link that this is a press release.

The big deal is that this is being posted on mainstream sites like WSJ and CNBC instead of the usual media blackout of anything questioning vaccine safety. Wow, maybe we are at a tipping point. I say keep the pressure on Offit until that f----- cracks. He clearly has a guilty conscience.

hera

hi Tina
I find it intriguing that you choose not to comment on the basis of the statements; that Dr Offit allegedly had a huge undisclosed conflict of interest,to the tune of millions, (while he was criticizing someone else for alleged financial conflicts, which appear to be completely dwarfed by his own)
yet you are worried about who wrote the article???
Apparently you don't dispute the facts it states? And aren't worried about them?

Hm.That perhaps says more about your own sense of integrity than anything else.

Sarah

Tina,

Before you accuse AoA, think about the fear tactics the Pharmaceuticals use to get their information out... much of what we read and hear about in the mainstream media about pandemics such as swine flu is likely from newsfeeds (infomercials) from Pharma. Noone discloses the source though.

Natasa

Press releases get issued all the time and very few make it to Reuters. Regardless of who wrote it and sent to whom, the fact that they issued/published/whatever is huge.

Managing Editor

Tina, we edited the headline. And I updated the presentation. It was my personal error in how I posted the release this morning - not an intentional attempt to mislead. Thanks for pointing it out to us, along with several other folks.

Kim

Tina

I think what you have done here is very wrong. This 'story' is a paid-for press release, presumably paid for by the NAA or by Thoughtful House, which was issued by PR Newswire. Many organizations harvest PR Newswire Press Releases.

You have taken the PR Newswire and press release references off the file - evidently carefully deleting them - and I think that really does raise issues of integrity at AoA.

I think you should promptly put the record straight, and apologize for any confusion. This is not a Reuters report, and you should not have claimed that it was. It is a paid-for press release, and I find it difficult to believe that you don't know that.

Thank you, Tina

Cindy K.

CNBC picked it up.

http://www.cnbc.com/id/32730171/site/14081545


Teresa Conrick

Ben's mom-

Here ya go:
http://www.marketwatch.com/story/offits-failure-to-disclose-jeopardizes-swine-flu-vaccine-program-2009-09-08

kathleen

Wow, this is a day I thought would NEVER happen, and couldn't be more pleased to see.

bensmyson

Please don't strike the messenger, but this seems to be a press release from the National Autism Association (NAA) via PRNewswire-USNewswire. The fact that it is on the Reuters website is impressive, let's hope it becomes a real story in mainstream media.

But where is the story about how GE, parent company of NBC, is in the vaccine making business?

http://www.gazette.net/stories/032808/businew202056_32374.shtml

Kelly

Just popped over to Dateline to comment on Reuter's ability to do some basic investigating.

Richard

Priceless!!! Give an idiot anough rope and they will hang themself everytime.

Ben's Mom

The big question will be who will pick this up off Reuter's and run it in the hometown rag or on the AOL, Yahoo, Google, MSN etc Webnews? Unless John Q. Public gets to read it, it's just a quick blip on the radar. We already know this Sh*t. We need other people to know it.

Schoolteacher in NYC

This is a press release not a news article!

jen

Holy crap!! Can you say tipping point!! I just may faint too this afternoon.

L. Stuiber

This is a great story. The biggest problem I have with it is why NBC is not taken to task in the same way? Even if Offit did not disclose his conflicts of interest with Merck, it is well know from his slap on the wrist from the US Congress and a report from the CBS evening news the he has these conflicts. Either way NBC looks bad by not reporting Offit’s conflicts. NBC should have also reported how much money they have accepted in advertising revenue from Merck. What’s the real difference? None of these supposed “News Organanizations” should be allowed to report “Health News” when they accept billions in add revenue. How can they be objective when the adverse events start occurring?

Natasa

Wow, mainstream media telling it like it is. Go Reuters!!!!!!!!

Teresa Conrick

How interesting that Reuter's picked this up and ran with it. Good for them! I imagine Paul Offit not echoing my sentiments too much as millions of people read about his sacrificing safety and children to make millions.

JTM

There is a post about this today at the Huffington Post.

http://www.huffingtonpost.com/jim-moore/the-real-health-care-scar_b_278981.html

Kathy Blanco

Love the illustration..perhaps it is telling as the pants have dropped down lower as more vaccines have been pushed in our kids, leaving them with oppositional defiant disorders (and other lovely DSM's)...or common decency? In like fashion.. Offit, again oppositionaly defiant, has no sense of these things (as in truth), nor wants to listen, when his ears are closed up with wax from dollar signs and impending pay checks that go CA CHING. Talk about the HEROD of our day?

Gatogorra

Almost all the news that was fit to print instead of the usual-- all the news that was s*** to print? I may faint. The misstatements on thimerosal were left out but it's extraordinary that Offit's glaring Dateline omissions are being scrutinized. Why now? Is it because average adults-- even those in the press-- are feeling the threat now that the syringes are aimed at them?

Craig Willoughby

Heh....the irony is delicious.

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