(2009-10-26) Brownlee Flu Contra

Shannon Brownlee says a number of doctors/researchers doubt The Flu orthodoxy - the effectiveness of the Flu Vaccine and antivirals. What if flu vaccines do not protect people from dying--particularly the elderly, who account for 90 percent of deaths from seasonal flu? And what if the expensive antiviral drugs that the government has stockpiled over the past few years also have little, if any, power to reduce the number of people who die or are hospitalized?

Today, seasonal flu is estimated to kill about 36,000 people in the United States each year, and half a million worldwide... Researchers have found that at most half, and perhaps as few as 7 or 8 percent, of such cases (where people believe they have The Flu) are actually caused by an influenza virus in any given year... Nobody knows precisely why we are much more likely to catch the flu in the winter months than at other times of the year.

In August, the President's Council of Advisors on Science and Technology projected that this fall and winter, the Swine Flu, H1N1, could infect anywhere between one-third and one-half of the U.S. population and could kill as many as 90,000 Americans, two and a half times the number killed in a typical flu season. But precisely how deadly, or even how infectious, this year's H1N1 pandemic will turn out to be won't be known until it's over.

Today, Flu Vaccine is a staple of public-health policy; in a normal year, some 100 million Americans get vaccinated. But while vaccines for, say, whooping cough and polio clearly and dramatically reduced death rates from those diseases, the impact of flu vaccine has been harder to determine... Such comparisons have shown a dramatic difference in mortality between these two groups: study after study has found that people who get a flu shot in the fall are about half as likely to die that winter--from any cause--as people who do not... Yet in the view of several vaccine skeptics, this claim is suspicious on its face. Influenza causes only a small minority of all deaths in the U.S., even among senior citizens, and even after adding in the deaths to which flu might have contributed indirectly. When researchers from the National Institute of Allergy and Infectious Diseases included all deaths from illnesses that flu aggravates, like lung disease or chronic heart failure, they found that flu accounts for, at most, 10 percent of winter deaths among the elderly. So how could flu vaccine possibly reduce total deaths by half?.. The estimate of 50 percent mortality reduction is based on "cohort studies," which compare death rates in large groups, or cohorts, of people who choose to be vaccinated, against death rates in groups who don't... Lisa Jackson's findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the "frail elderly" didn't or couldn't. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all.

The most vocal--and undoubtedly most vexing--critic of the gospel of flu vaccine is the Cochrane Collaboration's Tom Jefferson, who's also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson's view, makes other skeptics seem "moderate by comparison.".. Yet while other flu researchers may not like what Jefferson has to say, they cannot ignore the fact that he knows the flu-vaccine literature better than anyone else on the planet. He leads an international team of researchers who have combed through hundreds of flu-vaccine studies. The vast majority of the studies were deeply flawed, says Jefferson. "Rubbish is not a scientific term, but I think it's the term that applies." Only four studies were properly designed to pin down the effectiveness of flu vaccine, he says, and two of those showed that it might be effective in certain groups of patients, such as school-age children with no underlying health issues like asthma. The other two showed equivocal results or no benefit... These questions have led to the most controversial aspect of Jefferson's work: his call for Placebo-controlled Clinical Trial-s, studies that would randomly give half the test subjects vaccine and the other half a dummy shot, or placebo. Only such large, well-constructed, randomized trials can show with any precision how effective vaccine really is, and for whom.

Late last spring, as headlines and airwaves warned of a possible pandemic, patients like Newman's began clogging emergency rooms across the country, a sneezing, coughing, infectious tide of humanity more worried than truly sick, but whose mere presence in the emergency room has endangered the lives of others... Many of the worried sick come to St. Luke's and other hospitals in search of antiviral drugs. The CDC recommends the use of two drugs against H1N1: oseltamivir and zanamivir, better known by their brand names, Tamiflu and Relenza, which together form the second pillar of the government's anti-pandemic-flu strategy. Public-health officials at the state and local levels are also recommending the drugs. Guidelines issued by the New York City Department of Health, says Newman, "encourage us to give a prescription to just about every patient with the sniffles," a practice that some experts worry will quickly lead to resistant strains of the virus... Indeed, that's already happening. DanielJanies, an associate professor of biomedical informatics at Ohio State University, tracks the genetic mutations that allow flu virus to develop resistance to drugs. Flu can become resistant to Tamiflu in a matter of days, he says... By mid-August, two U.S. swine flu patients had developed Tamiflu-resistant strains... Before joining the Bush Cabinet, Donald Rumsfeld was chairman for four years of Gilead Sciences, the company that holds the patent on Tamiflu, and he held millions of dollars' worth of stock in the company... As with vaccines, the scientific evidence for Tamiflu and Relenza is thin at best. In its general-information section, the CDC's Web site tells readers that antiviral drugs can "make you feel better faster." True, but not by much. On average, Tamiflu (which accounts for 85 to 90 percent of the flu antiviral-drug market) cuts the duration of flu symptoms by 24hours in otherwise healthy people. In exchange for a slightly shorter bout of illness, as many as one in five people taking Tamiflu will experience nausea and vomiting. About one in five children will have neuropsychiatric side effects, possibly including anxiety and suicidal behavior... In both 2003 and 2009, reviews of randomized placebo-controlled studies (Clinical Trial) found that the study populations simply weren't large enough to answer the question: Does Tamiflu prevent pneumonia?... As late as this August, the company's own Web site contained the following statement, which was written under the direction of the FDA: "Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza."

Why, then, has the federal government stockpiled millions of doses of antivirals, at a cost of several billion dollars? And why are physicians being encouraged to hand out prescriptions to large numbers of people, without sound evidence that the drugs will help? The short answer may be that Public Health officials feel they must offer something, and these drugs are the only possible remedies at hand... The annals of medicine are littered with treatments and tests that became medical doctrine on the slimmest of evidence, and were then declared sacrosanct and beyond scientific investigation... "Vaccines give us a false sense of security," says Sumit Majumdar. "When you have a strategy that (everybody thinks) reduces death by 50 percent, it's pretty hard to invest resources to come up with better remedies."... In the U.S., by contrast, our reliance on vaccination may have the opposite effect: breeding feelings of invulnerability, and leading some people to ignore simple measures like better-than-normal hygiene, staying away from those who are sick, and staying home when they feel ill. Likewise, our encouragement of early treatment with antiviral drugs will likely lead many people to show up at the hospital at first sniffle. "There's no worse place to go than the hospital during flu season," says Majumdar. Those who don't have the flu are more likely to catch it there, and those who do will spread it around, he says. "But we don't tell people this."

Related: Rob Paterson notes that we don't even know how The Flu is transmitted!

Update: long response by Mark Crislip of Science Based Medicine blog.