OLMSTED ON AUTISM: MADE BY MERCK, STARTS WITH V …

[Guest guest]

http://www.ageofautism.com/2008/04/olmsted-on-au-1.html

04/16/2008

OLMSTED ON AUTISM: MADE BY MERCK, STARTS WITH V …

BY DAN OLMSTED

There it is, right next to the photo of the pope

and the president, the lead story in USA Today:

“Reports: Data on Vioxx misused.” Subhed:

“Documents suggest risk was downplayed.”

In brief – USA Today’s specialty – it turns out

that Merck “apparently downplayed evidence

showing the painkiller tripled the risk of death

in Alzheimer’s-prone patients, researchers report

today. A separate analysis of court documents

revealed that many Vioxx studies were prepared or

written by Merck employees or paid consultants,

not the doctors named as the studies’ lead authors, researchers say.”

One thing I can tell you from having worked at

The Nation’s Newspaper is that it has a very good

sense of the zeitgeist. I used to be in meetings

where the next day’s lead story was discussed,

and it had to be more than yesterday’s – or even

today’s – news. It had to help readers understand what was coming next.

One little adage we had was “three makes a

trend.” In other words, if Tom Petty, the B-52’s

and Whitney Houston all had hit songs at the same

time about drunken spouses, it was time to do a

story. We even had a formula for that kind of

story – we called it “three couples and a shrink”

– find three couples willing to talk about

dealing with alcoholism in their marriage, get a

psychiatrist to comment on it, and roll the presses.

I think we’ve got a trend going with Merck and

conveniently they all start with V – Vioxx,

live-virus vaccines and vaccine mercury, called

thimerosal. The new report in The Journal of the

American Medical Association – a mainstream

medical outlet if ever there was one – is

trashing Merck as basically committing scientific fraud that led to deaths.

So that's trend item one. Trend item two? You may

remember the piece in the LA Times by Myron

Levin from 2005. Here are the first few paragraphs:

“A memo from Merck & Co. shows that, nearly a

decade before the first public disclosure, senior

executives were concerned that infants were

getting an elevated dose of mercury in

vaccinations containing a widely used sterilizing agent.

“The March 1991 memo, obtained by The Times, said

that 6-month-old children who received their

shots on schedule would get a mercury dose up to

87 times higher than guidelines for the maximum

daily consumption of mercury from fish.

" 'When viewed in this way, the mercury load

appears rather large,’ said the memo from Dr.

Maurice R. Hilleman, an internationally renowned

vaccinologist. It was written to the president of Merck's vaccine division.

“The memo was prepared at a time when U.S. health

authorities were aggressively expanding their

immunization schedule by adding five new shots

for children in their first six months. Many of

these shots, as well as some previously included

on the vaccine schedule, contained thimerosal, an

antibacterial compound that is nearly 50% ethyl mercury, a neurotoxin.”

But we need one more item to declare an official,

USA Today-style trend, don’t we? Well, I’ve got

just the thing: The introduction, recommendation,

suspension and de-recommendation of ProQuad, the

first-ever 4-in-1 live virus vaccine, from Merck.

I’ve written about this in the seven-part Pox

series you can access from our home page by clicking on my UPI articles.

I spent three months on this because it seemed

like a really big deal to me, and it still does.

I documented two cases of autism following small

clinical trials in Olympia, Wash., leading to the

approval of ProQuad. When I asked Merck months

after those cases were diagnosed – and months

after the FDA approved the drug -- here’s what Merck said.

" ’We just received these reports in March 2006,

six months after ProQuad was approved in the

U.S., and they were sent to the FDA after we

received them,’ Merck's Fanelle said in

a statement. She said Merck received ‘the two

reports of autism AEs [adverse events] from

Olympia -- one from the parent of a child in the

ProQuad trial and one from the parent of a child

in (the 'process upgrade' chickenpox) study.’

“Parents Flinton and Baltzley

say they never called Merck and wouldn't know who

to contact there; last summer, Flinton

reported Jimmy's autism to the federal

government's Vaccine Adverse Events Reporting

System, attributing it to the cumulative effects

of vaccination. The federal health employee she

spoke to on the phone said she would follow up by

gathering lot numbers and other information on the vaccines.

“The parents said their pediatrician, who

conducted both of the Merck-funded trials in

Olympia, knew about their children's autism

diagnoses within months of their participation in

January 2001 and October 2002.

" The Olympia trials were part of wider Merck

studies conducted at several sites in the United

States and abroad. Fanelle said Merck would not

disclose information about any other reports of autism.”

Recently, I went back to Olympia and met with the

families again. I’ll be writing more about it,

but let me just say there are even more messed-up

kids who were in that trial than anybody realized

at the time. If the FDA and the CDC were doing

their job, they’d already have been out there.

(Not gonna happen, as H.W. Bush used to say.)

Merck has since said it doesn’t have enough

chickenpox virus to keep making ProQuad –

although it still churns out the standalone

chickenpox vaccine and the shingles vaccine,

which is loaded with chickenpox virus – and

suspended production until at least next year.

And the CDC’s vaccine advisory committee,

responding to a recent study showing that

fever-induced seizures were twice as likely in

kids receiving ProQuad as in kids receiving the

MMR and chickenpox shots separately, recently

dropped its preferential endorsement of ProQuad.

Anybody seriously looking at the events leading

up to the approval of Pro-Quad – and at the

pattern and practice evident in Merck’s Vioxx

behavior and its unacknowledged concerns about

thimerosal -- shouldn’t be surprised by any of

this. You could read all about it in the minutes

of a CDC meeting from well before ProQuad’s

approval. The issue was something called “viral

interference” – when you mix up a bunch of live

viruses in vaccines, they can interfere with each

other, and with the body’s immune response, in

ways that are unpredictable. I wrote:

“A Merck scientist discussed that issue at a CDC

meeting in 2004, the year before ProQuad was

approved, according to agency minutes. Dr.

Florian Schodel ‘confirmed the possibility that

the chickenpox virus component of ProQuad was

causing a local immune suppression and an

increase in measles virus replication. ... The

current hypothesis is that the varicella and

measles virus are co-infecting the same or

proximate areas of the body and engaging in a

specific interaction, but how that works is as yet unknown.’

“He said the interference appeared to involve

only the chickenpox and measles viruses – ‘there

is no such effect for the mumps or rubella

vaccines administered locally at the same time.’ "

Right there was fair warning – something was

happening here and we don’t know what it is. But

let’s approve and recommend it anyway.

Of course, Merck says that it in all these cases,

they’ve done nothing wrong, even though Vioxx is

off the market for good (and the subject of a $5

billion settlement agreement by Merck), ProQuad

is suspended and de-recommended, and the

government asked in 1999 that manufacturers

remove thimerosal from vaccines as soon as

possible, citing exactly the risk from that Merck memo written in 1991.

Sorry guys, I’m from the USA Today school: Three

makes a trend. It also makes three strikes.

You’re out.

--

Dan Olmsted is editor of Age of Autism.

in

<http://www.ageofautism.com/people_making_a_difference/index.html>Olmsted

on Autism ,

<http://www.ageofautism.com/vaccines/index.html>Vaccines

| <http://www.ageofautism.com/2008/04/olmsted-on-au-1.html>Permalink

<http://digg.com/submit?url=http://www.ageofautism.com/2008/04/olmsted-on-au-1.h\

tml & phase=2>Digg

This | <http://del.icio.us/post>Save to del.icio.us

TrackBack

TrackBack URL for this entry:

http://www.typepad.com/t/trackback/2465202/28169894

Listed below are links to weblogs that reference

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html>OLMSTED

ON AUTISM: MADE BY MERCK, STARTS WITH V …:

Comments

LoL, I linked through another site, pharmalot.com

and had to share-

<http://www.pharmalot.com/2008/04/the-merck-theme-song-ghostwriters-in-the-sky/>\

http://www.pharmalot.com/2008/04/the-merck-theme-song-ghostwriters-in-the-sky/

Just to add some humor to the thread, god knows I need a laugh today.

Posted by:

<http://www.typepad.com/t/comments?__mode=red & user_id=2465202 & id=110973400>Monic\

a

|

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html#comment-110973400>04/16\

/2008

at 01:14 PM

, I found the reply in that thread you

linked about gardasil particularly telling.

" What will be the nail in Merck's coffin is if

they find out that Gardisil is hurting our children. "

Yeah right, like there will be any regulatory

" finding out " at all going on WHEN the gardasil

kettle boils over and parents organize and really start fighting back.

Posted by: Josh Day |

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html#comment-110971666>04/16\

/2008

at 12:59 PM

Wanna further that trend? In my research ventures

(ugh, yes, I am a corporate headhunter, and had a

couple pHARMa heads to find), I came across

cafepharma.com. They have message boards, and a chat room for sales reps.

I was further infuriated at pHARMa and sure of

their deceit simply by the way the reps talk. But

I did see something interesting about Merck, a

thread titled " Merck is finished " . Looks like

they have a miltitude of troubles!

<http://www.cafepharma.com/boards/showthread.php?t=267028>http://www.cafepharma.\

com/boards/showthread.php?t=267028

I warn you though, there are MANY threads and it

is an active board, you may be stuck there for

awhile, I know I was! They really have such

disregard for patient safety, or doctors

intellect! They have boards for various topics,

including boards listed by company. looks like

Merck guys know they are in for it!

As always, a great read Dan, keep em coming!

Posted by:

<http://www.typepad.com/t/comments?__mode=red & user_id=2465202 & id=110969610>Monic\

a

|

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html#comment-110969610>04/16\

/2008

at 12:42 PM

Thanks, Dan, for getting all of this info out

there - it IS important... even one suspected

case of autism due to the chicken pox vaccine is

unacceptable! A shot that doesn't work well

anyway in preventing disease, wears off in a

small amount of time and leaves the population

vulnerable to chicken pox as it ages - worthless!

The fact that the chicken pox vaccine is on the

CDC schedule at all proves that the organization

is completely careless and unconcerned with

long-term effects. Why the AAP didn't nail them

on this addition in the 90's is a complete mystery to me.

Posted by: Sorsha |

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html#comment-110969538>04/16\

/2008

at 12:41 PM

" Of course, Merck says that it in all these

cases, they’ve done nothing wrong, even though

Vioxx is off the market for good (and the subject

of a $5 billion settlement agreement by Merck),

ProQuad is suspended and de-recommended, and the

government asked in 1999 that manufacturers

remove thimerosal from vaccines as soon as

possible, citing exactly the risk from that Merck memo written in 1991. "

Hmmm 1991 to 2008 - some 17 years and so many

thousands of kids injured and continue to be

injured each day. Knowing all this, *they*

continue to mandate newer and more shots to the

schedule - 7 in 1 strains, 5 in 1 shots. What are

they trying to do, deliberately obliterate the males?

And why does the government have to " ask " -

shouldn't the government demand or tell the

manufacturers this? Why does the the government

behave like its crippled or something? I guess we

know the answer to that one. So that would mean

that the recent public meetings are an eyewash as

well! Unless we are lucky enough to see something to the contrary.

Posted by: Merck'd |

<http://www.ageofautism.com/2008/04/olmsted-on-au-1.html#comment-110964626>04/16\

/2008

at 12:02 PM

I sure hope you're right Dan. So many great

stories like this have come and gone, though.

For instance, ghost-writing of journal articles

was the topic of a BMJ " news extra " in 2002

titled " Drug industry writers propose code of

ethical

conduct " (<http://www.vaccinationnews.com/DailyNews/April2002/DrugIndWritersPropo\

seCodeConduct.htm>http://www.vaccinationnews.com/DailyNews/April2002/DrugIndWrit\

ersProposeCodeConduct.htm

). They write of a JAMA article that reported

" Ghost writing is common in medical journals. In

a study of 809 articles published in six

different US peer reviewed medical journals, 11%

of articles were found to have ghost authors

(JAMA 1998;280:222-4). " They also note that " On

publication of the study, Drummond Rennie, deputy

editor of JAMA and one of the study’s authors,

condemned the practice as 'scandalous, and

outrageous " and 'a perfect illustration of

deceptive authorship practices for commercial

reasons' (Lancet 1999;354:136). " And now, 6 years

later it is news again, as if it is some sort of surprise.

Between ghost-writing by the drug companies,

reports of conflict of interest EVERYWHERE,

including NIH and the FDA, and all the other

corrupt and potentially corrupting practices out

there, it still seems that the sacred cow of

vaccines remains untouchable. When will the

media, and then the public, get that all these

problems with all these agencies and industry are

relevant to vaccines? When will they get that the

vaccine manufacturers have either bought outright

what we " know " about the safety of vaccines or at

least have influenced it? When will they get that this is terribly significant?

All the best, Sandy

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines -

http://www.wellwithin1.com/vaccine.htm Vaccine

Dangers & Childhood Disease & Homeopathy Email classes start April 18