Bioterrorism: We May Not Be So Lucky Next Time
It may be due to dumb luck â€“ not public health preparedness â€“ that only four people died from anthrax bioterrorism to date according to some experts. They warn that other organisms, such as smallpox, which are highly contagious, could cause hundreds of thousands of deaths in a matter of weeks.
Problems with the anthrax vaccine, tests, and treatment, seemingly hindered or misrepresented at every step by those who stand to make a buck, cause some to believe that unless the public health is placed ahead of profits, the public may not be able to expect adequate protection in the case of future bioterror attacks or naturally occurring epidemics.
Both the safety and efficacy of the anthrax vaccine are in serious doubt. Insider ties between the sole-source supplier of the vaccine, BioPort Corporation, and the Pentagon have raised questions about the multi-million dollar bailout provided by the Pentagon at a time when the company failed to pass FDA inspections.
The recent Cipro debacle, with sales skyrocketing in the month following September 11th, and profits for the drug running up to 5,000 percent higher than the cost of production, left more than a bitter taste in the mouths of many. More recently, the U.S. Food and Drug Administration is fast-tracking approval for a commercial anthrax test. But some doctors question the accuracy and value of the test.
Testing for serum parsnip levels
Since September 11th, doctors have been doling out advice ranging from bad to ludicrous according to some experts. Dr Isadore Rosenfeld writing in the November 12th issue of Parade magazine told readers that they should ask their doctor for Cipro or doxycycline if â€œâ€¦you find yourself surrounded by people who, suddenly and for no apparent reason, have come down with what is seemingly the fluâ€¦â€
However, such paranoia-inducing comments fly in the face of reason according to other doctors. Robert Solomon, MD, Vice Chair of the Department of Emergency Medicine at Ohio Valley Medical Center in Wheeling, West Virginia asks, â€œOne wonders if Dr Rosenfeld would consider that this is the flu season and that might be the reason patients have flu symptoms?â€
Unfortunately however, since early anthrax and flu have so many similar symptoms, and since anthrax cultures can take up to several days to yield results, some doctors heaved a sigh of relief on November 5, when the Mayo Clinic and Roche announced in a press conference that they jointly developed a new test that could diagnose anthrax in just 30 minutes. The new test relies on polymerase chain reaction (PCR) that can detect minute amounts of the DNA from the anthrax bacillus in a blood sample.
The claims made by Roche and the Mayo Clinic seem impressive. Franklin R. Cockerill, III, MD, the Mayo Clinic microbiologist who led the anthrax test development team claims that the test is 100 percent accurate when anthrax is present.
However, his claim is based only on test tube studies, and he acknowledges that no human studies with the Roche test have been concluded that would allow scientists to assess the test's accuracy in humans. Therefore, until human studies are completed, Dr. Cockerill recommends that the PCR test be used in conjunction with conventional culture-based testing methods.
Another problem with the Roche PCR test is that it canâ€™t deliver on the very thing doctors say they want most; the ability to reassure patients who donâ€™t have the anthrax. Thatâ€™s because even if the test can accurately identify patients with anthrax in their blood, such identification may come too late.
According to Dr Richard Meyer, bioterrorism laboratory director with the Centers for Disease Control and Prevention. â€œWe donâ€™t know enough about when anthrax appears in the bloodstream to be certain that sample collection after the onset of symptoms will be usefulâ€. Since anthrax is sequestered in the lungs and surrounding lymph nodes during the initial phases of infection, some fear that by the time anthrax appears in the blood, it may be too late to help the patient.
Solomon questions claims of 100 percent accuracy made by Roche, noting that there is no example of anything in medicine that is 100 percent accurate in humans. â€œThe PCR test is based on test tube studies, and if you have 100 percent accuracy in a test tube study, thatâ€™s wonderful. But it tells you absolutely nothing about what how it will perform in humans.
Even if the test is highly accurate â€“ and there is much reason to doubt it will be â€“ it wonâ€™t always be right. If you can't assuage a patientâ€™s fears in a way thatâ€™s intellectually honest then it is deceitful to hold out a negative test result as reassurance. If we're going to order the test knowing it will almost always be negative, because almost no one will have anthrax anyway, then all we're doing is pretending the reassurance is from the test rather than because of the extraordinarily low incidence of the disease.
If that's all we're doing, then a test for parsnip poisoning will serve the purpose quite nicely.â€
A recent CDC report lends weight to Dr Solomonâ€™s concerns. In comparing a commercial PCR test made by Idaho technologies, when six environmental samples grew anthrax on culture, a PCR assay was able to correctly identify anthrax in only two of the instances.
On the other hand, of eight samples identified as positive by PCR, only two were positive by culture. Several possible explanations for the testâ€™s inaccuracy were given including possible contamination, splitting of samples and errors in methods of sample collection and preparation.
In addition, it was noted that PCR could identify spores that were killed or non-viable, showing a positive result, while cultures would be negative.
Given such problems with anthrax prevention and testing, some doctors have suggested that patients get the flu shot. A microbiologist â€“ not a physician â€“ interviewed for a PBS show on bioterrorism weighed in with the idea that the â€œpatrioticâ€ thing to do is for all citizens of the U.S. to get the flu vaccine this year so doctors could tell who had the flu and who didnâ€™t.
However, Solomon scoffs at the notion that such an approach is useful for reassuring patients noting, â€œThe flu shot is only 70 percent effective in preventing influenza. This would leave a large group of people more, not less, worried that they have anthrax when they develop flu symptoms.â€
Others recommend testing for the flu when patients develop symptoms. But Solomon dismisses this strategy as well stating, â€œOf all the patients who present with flu symptoms, only half will actually have influenza. Of those patients, many will not test positive for it in the lab. So most patients with flu symptoms will not have a positive test for influenza. This will leave another group of people panic-stricken.â€
Roche has announced that for its â€œcontributionâ€ to the war against bioterrorism, they are donating free tests to a number of labs. But some see this as a cynical way to promote a questionable test. The tests will sell for $50 to $60 a piece and can only be run on Rocheâ€™s LightCycler machine that lists at $57,000.
Trading in fear â€“ Industry response to anthrax bioterror
The 19 percent profit margin enjoyed by the pharmaceutical industry is the highest of any industry, eclipsing the 5 percent median profits of all Fortune 500 firms.
Jerome Hoffman, Professor of Emergency Medicine at UCLA, remarks, â€œWhen a drug company can make a product that is both profitable and life-saving, itâ€™s a win-win situation for everybody. But any time it comes to a choice between the public health or profits, drug companies can and must sacrifice the former for the latter, because like all corporations they see their ultimate responsibility as being to their stockholders.â€
Although many believe that profit-motives are useful in fueling medical innovation and scientific excellence, critics believe that science itself is deformed by financial conflicts of interest.
Hoffman comments, â€œUnfortunately, since so much money is riding on the interpretation of scientific studies there is an enormous tendency to inflate both the level of evidence, and its significance. That may be why we seem to discover a great new cure for terrible diseases almost every day â€“ only to find out, over and over again, that very little has changed.â€
Hoffman suggests that a portion of drug company revenues should be placed in a central pot, to be administered to scientists by the National Institutes of Health, without any direct tie to the companies:
â€œIt is up to us â€“ the citizenry, not just physicians â€“ to demand that government look out for the public interest and not the corporate bottom line. We may have lucked out this time, because anthrax is hard to spread, but weâ€™d better think hard about fundamental changes if we donâ€™t want to be so dependent on luck in the future.â€
Jeanne Lenzer is a medical investigative journalist. Her writing has appeared in Mother Jones, USA Today, Praxis Post and Z magazine. She can be reached at Jlenzer1@csi.com