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 Christine 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 Jennifer Flinton and Kimberly Baltzley say they never called Merck and wouldn't know who to contact there; last summer, Jennifer 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 George 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.
Dan Olmsted is editor of Age of Autism.