Tick Tock

04.13.14

Thank Anti-Vaxxers for Lyme Disease

LYMErix, a promising vaccine for Lyme disease introduced in the ‘90s, was taken off the market due to pushback from anti-vaxxers (among other groups). Is it time to bring the drug back?

Well it’s springtime once again. Flowers are blooming, love is in the air, and hopefulness abounds for one and all.

Except infectious disease specialists: for us, spring signals the start of Lyme season, a months-long slog through patient doubt and acrimony that makes us root for the bitter bite of winter to still the hopping, blood-sucking advance of the tick.  April is indeed the cruelest month, not only breeding lilacs from the dead but awakening countless nymph ticks from a months-long slumber, each desperate to find a leg or hairy back to set up shop and take a vampiric meal.

The intense controversy may seem odd, especially since we have had a trustworthy and no-big-deal Lyme vaccine for dogs for awhile now.

First described almost 40 years ago, little has changed about Lyme diagnostics or treatment in the last few decades.  What has happened however is the birth and continued growth of a group of patients who have chased the concept of the condition called “chronic Lyme disease” to the ends of science and beyond. Chronic Lyme is a protean disease said to affect primarily neurologic function; the remedy, according to believers in the syndrome, is long-term, if not indefinite, courses of intravenous antibiotics.

The group has substantial influence. In 2002 an FDA-approved Lyme vaccine was an unexpected victim of the ongoing struggle between chronic Lyme advocates and those who ascribe to the orthodoxies of allopathic medicine, a semi-derogatory term used to refer to those who went the boring route to medical school and who read conventional textbooks and ascribe to the accumulated wisdom and evidence of generations of traditional boring physicians (like me).

I recently wrote about the rise and fall of LYMErix™ (also summarized here, the only medical product ever withdrawn from the market not because of science but because of the incredible public to-do about it. The intense controversy may seem odd, especially since we have had a trustworthy and no-big-deal Lyme vaccine for dogs for awhile now; but the leap from man’s best friend to man proved complicated. The vaccine somehow was forced to swim against the riptide caused by both the pro-chronic Lyme crowd who regard the vaccine to be as bad as the disease, and the equally forceful anti-any-vaccine contingent.

The story, briefly, is that, in the late 1990s, a pretty good (not great) vaccine demonstrated a real reduction in Lyme cases.  But rather than being greeted as liberators, the vaccine and the scientific community found themselves entangled in an impressive mess: vaccine recipients, egged on by TV reports of aches and arthritis as well as a fleet of well-turned-out lawyers who were very busy but had a little time for you if you had a complaint about the vaccine, soon sank the product under a welter of threats, suits, and people wearing suits. The maker of LYMErix™ tossed in the towel despite no compelling scientific evidence showing any problem with vaccine.

The Lyme vaccine fault lines have been re-exposed in recent months as Austrian researchers reported a preliminary study examining a novel Lyme vaccine in the medical journal Lancet Infectious Disease. They administered the vaccine to 300 volunteers and showed a strong suggestion that the vaccine will be effective and not harmful.

Good news, right?

Think again. The finding was immediately pounced upon by members of the International Lyme and Associated Diseases Society (of Bethesda, Md.). They wrote a scathing critique of the findings, harkening back to the Original Sin in Lyme vaccine history, LYMErix™. Seizing on (well-earned) distrust of Big Pharma, they claimed that safety data was withheld, that a plausible biologic path to chronic arthritis from both the vaccine and the disease was already well-established, and that LYMErix™ was withdrawn not because the company chickened out, but because the move protected it from even more lawsuits. 

In response, the Austrian investigators and the American expert, Dr. Paul Lantos, who had written a hopeful editorial entitled, “Lyme disease vaccine: Are we ready to try again?” refuted the claims, pointing out the thorough review of the data conducted by the FDA found no evidence of increased risk of arthritis.

The FDA (full disclosure: I have served as a member of an Advisory Committee to the FDA and admire their work) examined both the 21,000 people in the clinical trials and reports from the 1.4 million recipients of the vaccine given after approval. They found no difference in the clinical trials in rates of arthritis between those who received vaccine versus those who were given placebo. They also found a rate of arthritis in the 1.4 million recipients identical to the rate found in the general population. 

Surely this is the start of yet another screaming match.  We have the rarest of paradoxes: the group that feels most aggrieved by a disease—those with “chronic Lyme”—is the very same group that is fighting tooth and nail to prevent its prevention. Given this odd situation, it is uncertain how the coming debate will play out. It also is uncertain whether science once again will be swept into the dustbin of history by chronic Lyme boosters and veteran vaccine bashers. 

Should science cave in to the irrational and tenacious noise-machine a second time, however, it is the scientists and not the inflamed advocacy groups who should be ashamed.