Posted on 10/19/2004 10:05:37 PM PDT by neverdem
It is almost unbelievable - and surely unacceptable - that the world's most medically advanced nation should suddenly find nearly half of its expected supply of influenza vaccine wiped out by manufacturing problems at a single plant in England. Yet that is the shocking reality that has panicky patients lining up for flu shots that are not available and has price gougers trying to profit from their misery.
There is plenty of blame to go around for this fiasco. The primary fault lies with Chiron, an American biotechnology company, based in California, that had planned to supply some 46 million to 48 million doses of vaccine to the United States from a plant in Liverpool it acquired last year. That plant had a history of problems under a succession of previous owners, and Chiron may well have put it under additional stress with a huge ramp-up in production for this year's flu season. The result was a major malfunction.
In late August, Chiron detected bacterial contamination that might have infected millions of doses. But the company remained confident - and the Food and Drug Administration remained hopeful - that the problem had been contained. Then came the coup de grâce. British regulators suspended the firm's flu vaccine license early this month because of unspecified failures to comply with good manufacturing practices, suggesting a more deep-seated problem.
American health officials had no clue that almost half of the nation's flu vaccine supply was about to be impounded. The question that has to be explored is whether the F.D.A. was asleep at the switch. There had been hints of trouble in the past. An F.D.A. inspection of the plant in June 2003 found quality-control problems and bacterial contamination at an early stage of the production process, but those shortcomings were reportedly resolved, allowing Chiron to produce clean vaccine for last year's flu season. Now even more severe contamination has emerged in this year's production, forcing Chiron to the sidelines. Congressional committees will need to determine whether the federal drug agency pushed hard enough over the past year to ensure that the Liverpool plant could be relied on.
They will also need to investigate whether the F.D.A. responded fast enough after the first reports of contamination in August. Events leave the impression that the company deluded itself into thinking the problem had been isolated and that the drug agency more or less accepted its reassurances. We are left to guess whether more aggressive intervention by government experts might have helped the company surmount its difficulties.
By late August there was little hope of finding enough additional vaccine elsewhere. But a nearly total breakdown in communication between British and American regulators surely slowed this nation's response to the crisis. The British failed to alert the F.D.A. that they were inspecting the plant for deficiencies in late September, and they gave no hint that they were considering a license suspension until the deed was done. The F.D.A. seems to have made no great effort to stay on top of what the British were doing. With some 90 percent of the plant's flu vaccine headed for the United States, that seems an unforgivable lapse by regulators on both sides of the Atlantic. American health officials need to press their British colleagues for a better alert system.
Underlying this crisis is the increasing fragility of the vaccine manufacturing base. This may be mostly an American problem rather than a global problem. There are six major manufacturers in the world who produced some 200 million doses for other nations this year, but only two of them are licensed to produce the 100 million doses of injectable vaccine for this country. The British coped with the loss of Chiron's vaccine far better than the United States, mostly because they order far less vaccine and have a diversity of suppliers that can fill in if one company falters.
Experts are pondering ways to induce more companies to make flu vaccine for the American market. The issue is not that manufacturers are worried about lawsuits over liability, as President Bush has suggested. Litigation is seldom, if ever, cited in authoritative analyses of vaccine shortages. The main problem is that influenza vaccine needs to be reformulated every year, and companies suffer huge losses if they overestimate the amount that will be needed because they end up having to destroy millions of doses. The administration needs to find a way to expand and stabilize the vaccine manufacturing base. The lesson of the Chiron debacle is that a diversity of supply is critical.
They could have linked these authoritative analyses. Don't hold your breath waiting for the "paper of record" to say or do anything that could be critical of the trial lawyers.
Hillary Rodham Rodham created this in the one part of HillaryCare to be enacted into law: setting mandatory price controls on vaccines in 1995, while failing to end the liability lottery of the democrat party's trial lawyer SS brigade.
Perhaps I missed it but every article on this subject lists the problem with one company. What about the other products that are available such as Tamiflu from Roche?
We have a war going on, international terrorism . . . and the MSM/DNC are trying to make hay and are pretending to worry about . . . flu shots? What's next, shortage of band-aids?!
Does it matter (for more than several people)? From what I understand the vaccine isn't effective on the "1918" kind of flu anyway. The vaccine may save a few lives but couldn't stop a pandemic strain. Give the kids and elders the shot and the rest of us should just sniffle and build up immunities.
Tamiflu is indicated within 48 hours of a suspected case of influenza. It can be used for prophylaxis in people 13 years old or older. It would be fairly expensive, and I don't think Roche has that much of a supply on hand.
We have tons of anti-virals effective against the flu. If you suspect the flu, get to your doc ASAP as a walk-in and get an injection. It will either stop the flu in its tracks or reduce the severity by at least half. The key is to not wait for an appointment, but get yourself to the doc within 24 hours of the symptoms setting in (high fever, muscle aches, severe headache).
Correct me if wrong, but I don't believe there are any the can be used as an injection once you have infuenza. Amantadine, which is good for the treatment and prophylaxis of the A strain of influenza, and Tamiflu, oseltamivir, which is good for the treatment and prophylaxis of both A and B strains, are both pills or solutions taken orally. Relenza has the same uses as Tamiflu, but it uses an inhalation device.
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