Re: [LD] Is the Lyme Disease Vaccine a Lemon?

[Guest guest]

Is there maybe some sort of monetary gain for the FDA in deciding what is safe to take?

http://my.webmd.com/content/article/1728.71258Is the Lyme Disease Vaccine a Lemon?Experts Consider Safety ConcernsBy WebMD Washington CorrespondentReviewed by Dr. Craig KligerJan. 31, 2001 (Washington) -- Could a vaccine be more dangerous than thedisease it's supposed to prevent? That question was heavy in the airWednesday, as the Food and Drug Administration's Vaccines and RelatedBiological Products Advisory Committee held a special session on the safetyof Glaxo Kline's Lyme disease vaccine LYMErix.The panel held the meeting to review reports that indicate the vaccine maysomehow trigger treatment-resistant Lyme arthritis and other chronicarthritic disorders.About two-and-a-half years ago, the same committee had recommended that theFDA approve the vaccine, and panel members said they were frustrated thatadditional studies have failed to clear up uncertainties about adverseevents that may be linked to the vaccine.In the end, most panel members said they supported revisions and possiblenew warnings on the vaccine's package inserts, as well as heightened publiceducation about the potential risks of the vaccine.Lyme disease most commonly affects individuals in New England and themid-Atlantic states. It's transferred to humans via deer ticks that live ingrassy and wooded areas, with May and June being the highest-risk months fortransmission. The disease was first recognized in 1975, and the vaccinemaker says that it is still on the rise. More than 100,000 cases werereported to the federal government between 1982 and 1998.Lyme disease isn't life threatening, but its long-term effects can includejoints destruction, neurological disorders, and other serious conditions.The LYMErix vaccine was approved late in 1998 for use in those at least 15years old. It's been marketed in the U.S. since January 1999, and GlaxoKline says that it has distributed 1.4 million doses, although itacknowledged that fewer patients than expected have actually received thevaccine.The vaccine series, which is administered in three separate doses, isrelatively costly. Each dose costs about $50. Despite the cost, itseffectiveness is somewhere less than 80%.Even as panel members noted that science on the vaccine's safety has notadvanced in recent years, they said that anecdotal complaints from patientshave increased dramatically. A series of Lyme vaccine recipients and patientadvocates made often-emotional presentations to the panel, urging that thevaccine be pulled from the market, that it be put on hold until ongoingsafety studies are completed, or that stronger warnings go on the product'slabeling.But a series of researchers from Glaxo Kline maintained that thevaccine was unrelated to arthritis or other mysterious conditions, andoutlined a set of studies that it has under way. The company says that theproduct's safety profile hasn't changed since it was approved.The patients' testimonials clearly had an effect on the advisory committee.In his closing remarks, W. O'Fallon, PhD, an invited participant inthe panel's discussion, said, "Would I take the vaccine? No." Luft, MD, another invited participant, cited a "twilight zone" ofdisconnect in the conflicting accounts of the vaccine recipients and thedrug firm.According to panel member s, MD, a "huge body of anecdotaldata" suggests that "we may be missing something."Almost 1,000 adverse event reports have been filed on the Lyme vaccine, witharound 70 citing arthritis-like side effects. Four deaths also have beenreported following administration of the vaccine.But according to Glaxo Kline, the events have taken no particularclinical pattern and "no cluster in time to onset."According to the FDA, the rates of arthritis suffered by those who've takenthe vaccine aren't higher than rates among the general population.The FDA holds that more adverse events are occurring than are reported, butagrees with the vaccine maker that most of the reported events involve sideeffects already described in the vaccine's physician labeling.The company says it has experience with more than 18,000 subjects incontrolled investigations, including more than 8,000 post-licensurevaccinees.Glaxo Kline presented animal study data that it claimed supported itsposition that the vaccine is unrelated to the arthritis. But panel memberSteve Kohl, MD, and others said the study was irrelevant to the nature ofthe possible problem in humans.The drugmaker also said that it was tracking actual vaccinations asdelivered by physicians through three HMOs, so it can closely followthousands of doses, possible side effects, and follow-up medical care. Bythe end of the year, said Glaxo researcher Platt, MD, "We will havereal information about the relative risks."But several members of the panel said that they were worried that the studywould not be large enough to provide definitive data on the supposedconnection between the vaccine and arthritis.The panel did not hold any formal votes and is not responsible for decidingFDA policy.© 2001 WebMD Corporation. All rights reserved.

The human spirit is stronger than anything that canhappen to it.

C.