Sam Uretsky

Flimsy Evidence for Flu Meds

Type “flu season 2012” into Google News and you get 1,200,000 results in 0.18 seconds. These include the New York Post front page “Flu York” and Pharmacy Times headlining “Intense Flu Season Arrives Earlier Than Usual.” Medical Daily sums it up in their headline “During One of the Worst Flu Seasons in 10 Years, Manufacturers Are Running Out of Vaccines and Treatments.” It gets worse. Everything we thought we knew may be wrong.

The Cochrane Collaboration is one of the most reliable resources on medical treatments. It’s an international group of volunteers who carefully examine the professional literature, and determine whether a drug or procedure has a role in patient care. This type of unbiased review is essential because studies, even those published in the most reliable journals, aren’t always accurate. In some cases, there’s publication bias. Both authors and editors are unenthusiastic about those studies, and may not bother submitting or publishing the result. In other cases, the studies may not give the results the sponsor was looking for, and so these studies are never submitted for publication. Finally, a study may have been designed to show that the sponsor’s product is superior to the competitor’s, and yes, these studies can be reviewed and published, but they won’t hold up to scrutiny. There are a lot of physicians who can pick up a journal, read the abstract (the summary) then jump fo the conclusions, without bothering to see how the study was conducted, or what the actual results were.

When the Cochrane group looked at the published results for the neuraminidase inhibitors such as oseltamivir (Tamiflu®) and zanamivir (Relenza®) they found there weren’t very many available. They asked for the materials submitted to the regulatory agencies such as the Food & Drug Administration, which determine whether a drug should be marketed. What they found appears to be evidence of suppressed publications. Although governments have spent billions of dollars reimbursing patients for oseltamivir, and stockpiling the drug in the event of an influenza epidemic, the decisions have been made on the basis of published reports and not the full data. The Cochrane report states “Having pieced together information from more than 16,000 pages of clinical trial data and documents used in the process of licensing oseltamivir, the Cochrane team raises critical questions about how well the drug works, as well as about its reported safety profile. While the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment. Results from the reanalysis of data also raise questions about how the drug works as an influenza virus inhibitor.”

The medical journal BMJ (formerly known as the British Medical Journal) has an ongoing campaign to make all clinical data available for evaluation, and has encouraged the British National Health Service to investigate the costs that resulted from decisions made in the absence of full information.

Flu vaccine may not be much better. It’s fairly well known by now that the United States’ Center for Communicable Disease Control and Prevention (CDC) did an evaluation of the effectiveness of the vaccine in healthy young individuals. In an editorial note to their report, they state: “Influenza vaccination, even with moderate effectiveness, has been shown to reduce illness, antibiotic use, doctor visits, time lost from work, hospitalizations, and deaths. Results for the 2012–13 season indicate that vaccination has reduced the risk for influenza-associated medical visits by approximately 60%, demonstrating the benefits of influenza vaccination during the current season.”

This report of efficacy lines up with a report from the University of Minnesota Center for Infectious Disease Research & Policy, published October 2012. The report was titled “The Compelling Need for Game-Changing Influenza Vaccines.” Their fist key finding was, “During some influenza seasons vaccination offers substantially more protection for most of the population than being unvaccinated; however, influenza vaccine protection is markedly lower than for most routinely recommended vaccines and is suboptimal.” The report concluded that as a matter of public health and safety, we need to replace the current vaccines with new game-changing technology – vaccines that will last several years and have a higher level of effectiveness. Their concern is that while a new vaccine might be cost effective in the long run, the costs of development would be high, and because it would have to sell at a higher price than current vaccines, vaccine manufacturers are reluctant to undertake development of better vaccines without guaranteed profits. The reviewers suggest that the government and industry for a partnership to guarantee the vaccine manufacturers a profit on a new influenza vaccine.

Oh yes – this is only peripherally related, but last May, two former Merck employees brought a whistleblower suit against the drug and vaccine maker, claiming Merck had overstated the effectiveness of its measles, mumps, rubella vaccine. The whistleblowers claim that Merck defrauded the US government with false claims of efficacy so that the government bought 4 million doses of the vaccine every year for 10 years. Maybe the people in Minnesota needn’t worry about the vaccine makers and drug companies being assured of a profit. It sounds as if they’re doing fine on their own.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. Email sdu01@mail.com.

From The Progressive Populist, February 15, 2013