The Life & Death of A Vaccine

The life and death of a vaccine

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The life and death of a vaccine

By Stephen Smith, Globe Staff, 5/18/2002

s drug discoveries go, it was a spectacular rise - followed by an even more astonishing fall.

LYMErix, the first vaccine against Lyme disease, burst onto the market in the spring of 1999 with the promise of reversing the march of a tick-borne illness that strikes thousands of people every year, mostly in the Northeast. In that first year alone, hundreds of thousands of people took the shot, generating $40 million in sales.

Then, just as quickly as it arrived, LYMErix was gone, yanked voluntarily in February by its manufacturer, GlaxoSmithKline, which cited a precipitous drop in sales, with fewer than 10,000 people expected to get the vaccine this year. Because Lyme disease is rarely fatal, potential customers apparently decided the vaccine wasn't worth the risk.

In its wake, LYMErix has left hundreds of lawsuits alleging that the shot caused painful, even ruinous complications in patients.

The demise of LYMErix - and what caused it to ''crash and burn,'' as one Tufts University researcher put it - provides a vivid answer to the question: Why don't scientists develop vaccines for more diseases?

Researchers familiar with vaccine development speculate that the inoculation was doomed by the calculus that determines the success of any drug: People decided that the perceived risk of complications from the shot outweighed the benefit of preventing a disease that can be treated if caught early enough and avoided altogether by keeping deer ticks off the skin.

''If people are hearing news reports that you can get autoimmune disease from taking this vaccine, they're going to run away screaming,'' said Dr. Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development. ''So your market basically goes down the tubes.''

The failure of LYMErix represents the latest challenge in a segment of the pharmaceutical industry often viewed as a stepchild. Vaccine development does not have the same income potential as blockbuster drugs to treat chronic conditions such as high blood pressure. Vaccines must be priced affordably to reach the broadest market, and they're often a one-shot deal.

Since the 19th century, vaccines have ranked among medicine's greatest successes. But in recent years, a small, albeit vocal, lobby emerged to oppose vaccination, arguing that shots meant to grant protection too often cause harm.

''For somebody like me, it's very straightforward - why would you not want to prevent infectious diseases?'' said Dr. Charles Prober, a Stanford University specialist in infectious diseases. ''But there are some people who do not want foreign proteins in their body.''

The market appeared promising when LYMErix was approved by federal drug regulators in December 1998. Lyme disease had spread fear throughout the 1980s and 1990s, as tiny deer ticks infected people with bacteria that can cause severe joint pain and debilitating fatigue. While antibiotics successfully treated the illness in many patients, others were beset with persistent symptoms. Researchers turned their microscopes toward a vaccine.

LYMErix contains a protein designed to marshal the human body's army of disease fighters to repel the bacteria that cause illness.

In a review of the dozen drug studies that led to the federal approval of LYMErix, Reichert found that almost 22,000 people participated in the trials. For a biopharmaceutical such as LYMErix, Reichert said, that gave great credibility to the conclusion that the vaccine was safe.

The Lyme vaccine required three shots given over a year, and Glaxo reports that 1.5 million doses were supplied during 1999.

By July 1999, however, problems allegedly associated with the vaccine already were being reported. Philadelphia attorney Stephen A. Sheller was beginning to receive calls from patients and doctors reporting that LYMErix had caused severe side effects. Vaccine recipients reported aches and pains that resembled arthritis, while others complained of malaise and memory loss. In December 1999, Sheller sued the drug maker; today, the roster of LYMErix clients at Sheller's firm stretches 400 names long.

Dr. Norman Latov, a neurologist at Cornell University's Weill Medical College in New York, first became aware of the alleged complications caused by the vaccine a few months ago. He started seeing patients with unusual neurological problems. They reported weakness, numbness, and pain in their arms and legs. In some of the 10 patients whose conditions Latov links to LYMErix, their brains had been damaged, leaving the patients unable to retrieve the details needed for the chores of daily life. Those neurological complications had not been predicted in the trials of LYMErix.

A risk of any vaccine is that it will overstimulate the body's immune system or provoke an inappropriate response. Latov and other doctors believe that LYMErix caused some patients' immune systems to turn on their own bodies, becoming a force of destruction rather than an agent of protection.

The Food and Drug Administration and Centers for Disease Control examined 905 reports of adverse events. Their conclusion: Neither the number of complaints nor their severity was beyond what would have been anticipated, based on the clinical studies.

''I think the vaccine was a useful tool for preventing Lyme disease,'' said Dr. Ned Hayes, epidemiology chief in CDC's Lyme disease program.

The decision to withdraw LYMErix, a Glaxo spokeswoman said, was driven exclusively by the lack of sales. After the first year of strong results, sales plummeted to less than $5 million by 2001, Ramona DuBose said.

Although the company would not disclose how much was spent to develop the vaccine, trade groups cite a figure of $800 million as the average cost to bring a drug to the pharmacy shelf.

''Despite our best efforts, the demand for the vaccine just never reached a sustainable level,'' DuBose said. ''We knew that the marketing of this vaccine would be a challenge, because Lyme disease is poorly understood. We worked on trying to overcome that by educating physicians and the public about why it could be beneficial to take the vaccine. But still there was not enough demand.''

This story ran on page A1 of the Boston Globe on 5/18/2002.

© Copyright 2002 Globe Newspaper Company.

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