The Flu Vaccine Question By FRED GARDNER
President Bush misstated the facts about the flu-vaccine shortage in the Oct. 13 debate. Neither Senator Kerry nor Bob Schieffer refuted him. Nor did any of the post-debate pundits. It wasn't until the next day that Keith Olberman focused on Bush's "errors" regarding the vaccine fiasco -and his commentator, Craig Crawford, made light of it.
Schieffer had asked, "Suddenly we find ourselves with a severe shortage of flu vaccine. How did that happen?"
Bush answered confidently, "Bob, we relied upon a company out of England to provide about half of the flu vaccines for the United States citizens and it turned out that the vaccine they were producing was contaminated. And so we took the right action and didn't allow contaminated medicine into our country."
Actually, the suspect vaccine was made by Chiron, which is headquartered in Emeryville, California. Last month the British Medicines and Healthcare products Regulatory Agency, the equivalent of our FDA, closed the factory in Liverpool at which Chiron was making flu vaccine for the U.S. market. The MHRA impounded all the vaccine (while Chiron execs protested that only a small percentage was contaminated and the FDA asked for more information).
Chiron scientists had no experience producing flu vaccine by the current method, which involves injecting viruses into the embryos of eggs that then get incubated, hatched, and processed. Chiron has a long-term plan to manufacture vaccines by a yet-to-be-perfected cell-culture technique. To gain entrée to the flu-vaccine market, they bought the Liverpool egg-embryo-culturing facility in early 2003 and assumed responsibility for providing half the U.S. supply (48 million doses).
In the summer of 2003 U.S. FDA inspectors found "deviations" from good manufacturing procedures at the Liverpool facility -equipment that wasn't sterilized, variations in potency and stability, and high levels of bacteria in some unfinished batches of vaccine. According to the Wall St. Journal, "John Taylor, the FDA's associate commissioner for regulatory affairs, said 'systemic quality-control issues' led inspectors to conclude that Chiron wouldn't necessarily be able to discover problems, identify the root cause and take steps to prevent similar issues from arising again." But the FDA wasn't moved to intervene, even after Chiron reported in August of this year that finished batches of vaccine at the Liverpool plant were contaminated with serratia, a bacteria that can cause bloodstream infections. Good thing the MHRA was on the case.
Kerry has accused Bush of misinforming the American people, but he missed a chance to pounce on a vivid example. He wasn't in real debate mode. He ignored Bush's answer -and Shieffer's question- and went straight into his own prepared healthcare riff. As for Shieffer, he asked the question -wasn't it his responsibility to know the relevant facts and hold the candidates to them?
Bush went on to say "We have a problem with litigation in the United States of America. Vaccine manufacturers are worried about getting sued and so therefore they have backed off from providing this kind of vaccine." This was accurate -an accurate reflection of the manufacturers' point of view. From the citizens' point of view, we have a problem with mercury in our vaccines.
It seemed as if the Republicans had anticipated the vaccine question. By coincidence or design, Sen. Majority leader Bill Frist was the spokesman they made available to MSNBC after the debate. It was Frist who wrote the measure inserted into the Homeland Security bill that protects Eli Lilly from lawsuits alleging that a mercury-based vaccine preservative causes autism.
Merck was once an honored name. The Merck Manual was relied on by every doctor, the Merck Index by every chemist. To people in lab coats, Merck meant the exact definition. Today Merck means Vioxx and spin.
Merck was spending $8.5 million a month advertising Vioxx until the CEO announced a "voluntary recall" in late September. Merck's prescription painkiller was peddled so persistently on TV that "It's a beautiful morning" must have been lilting into the ears of at least a few arthritis sufferers as their Vioxx-induced heart attacks and strokes onset. Maybe some were even humming along: "It's a beautiful morn-AAARGH."
It's not funny, I know, it's a form of assault, even murder. More than two million Americans had been taking Vioxx, and thousands of them will suffer grave consequences. Many already have. In 2003 Merck sold $2.5 billion worth of Vioxx, accounting for 11% of their worldwide sales.
This is a drug for which there was only a trumped-up need, and for which there would have been no need whatsoever if the DEA allowed U.S. doctors to prescribe codeine readily -not to mention cannabis.
"Safety" was the rationale for developing Vioxx (and Celebrex, now made by Pfizer but developed by G.D. Searle, a Monsanto subsidiary). Aspirin and other non-steroidal inflammatories such as ibuprofen (Motrin, Advil) and naproxen (Aleve) are effective, but large doses can cause gastrointestinal bleeding and peptic ulcers in some people. (Tylenol isn't anti-inflammatory at all. It reduces pain and fever while damaging the liver.) So the drug companies saw an "easier-on-the-stomach" marketing niche that, given the prevalence of arthritis and chronic pain -and the rationing of codeine and prohibition of cannabis- could prove lucrative.
Aspirin and the other NSAIDs work by inhibiting an enzyme called cyclooxygenase (Cox), that helps make compounds called prostaglandins that facilitate the inflammatory response and have other important functions, including protecting the stomach lining and maintaining kidney function. In the 1980s a team led by Searle researcher Philip Needleman found that there are two forms of cyclooxygenase (Cox-1 and Cox-2). Because the NSAIDS inhibited Cox-1 more than Cox-2, and because Cox-2 was more prevalent in damaged tissues associated with arthritis, it was hoped that a drug that inhibited only Cox-2 production would reduce inflammation without gastric side effects.
So, billions were invested in research and development, and the Cox-2 inhibitors were pushed towards the market. One of Merck's early studies showed that patients on Vioxx suffered more heart attacks than patients on naproxen, but the company claimed, without evidence, that this was due to some protective effect of naproxen, and the FDA bought it. (Aspirin reduces heart attacks; naproxen doesn't.) People with heart problems were excluded from subsequent clinical trials of Vioxx. The goal of the large-scale study that revealed a 200% increase in heart attacks and strokes was to show that Vioxx reduced polyps in the colon! Merck was looking for an additional marketing niche, not trying to answer ominous questions about the safety profile of its #3 bestseller.
According to Marcia Angell, MD, former editor of the New England Journal of Medicine, "It is likely that many more people had heart attacks and strokes from Vioxx than were saved from bleeding ulcers, given the high prevalence of heart disease in the population that uses Vioxx and the deliberate exclusion of those people in the trial... Cox 2 inhibitors like Vioxx are no better than over-the-counter drugs for relieving arthritis symptoms (they do not enable you to skate like Dorothy Hamill), far more expensive and of only limited effectiveness in preventing gastrointestinal complications."
Marcia hasn't always been an angel when it comes to full and frank criticism of the medical establishment. As editor of the NEJM she ardently vouched for the safety of silicon breast implants on behalf of the manufacturers. But now she's calling on the FDA to require long-term trials of Celebrex and other Cox-2 inhibitors. (Celebrex is currently being tested as an anti-polyp drug in two clinical trials and to slow the progression of Alzheimer's disease in another. Pfizer will report any safety problems.)
U.S. drug companies spent $3.8 billion last year on advertising aimed directly at consumers -a practice that was illegal until the mid-1990s but now is upheld as some sacred "consumers' right to know." Kerry and Edwards have mentioned that direct-to consumer advertising of pharmaceuticals drives up health-care costs, but don't expect the corporate media, with so much revenue at stake, to publicize the issue.
CEO Raymond Gilmartin was twitching (probably due to a cannabinoid deficiency) when he announced Merck's "voluntary" recall of Vioxx, but he managed to take credit for conscientious corporate behavior -and the media played along. The struggle is now on for the hearts and minds of jurors who will decide what Merck owes to thousands of victims. The company has begun the search for Gilmartin's successor by auditioning several headhunter firms. Could you design a system more irrational, wasteful, corrupt, unfair, and inefficient than capitalism in this late, degenerate stage?
Fred Gardner can be reached at email@example.com