Testimony of Dr. Margaret Dayhoff-Brannigan
FDA Advisory Committee on Flu Vaccines
My name is Dr. Margaret Dayhoff-Brannigan and I am the Patient Network Project Manager at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.
Thank you for the opportunity to speak here today.
I completed my Ph.D. in Biochemistry and Molecular Biology at the Johns Hopkins School of Public Health. I bring a perspective as both a researcher and an advocate for public health here today.
I am here today to express our very strong concerns about the contradictory statements and evidence regarding flu vaccines and antiviral medications from two federal public health agencies, the FDA and the CDC. Patients and physicians are not well served when the CDC seems to be promoting medical products rather than providing facts made available by FDA analyses.
An effective flu vaccine is critical for public health. The 2014-2015 vaccine had only a 23% efficacy. While this year’s vaccine efficiency was an improvement, it is important that we implement strategies to improve the consistent efficacy of the influenza vaccine. When the flu vaccine does not work well, people think they should not bother to get it. This is bad for both for the pharmaceutical companies who have unused doses of vaccine, and for the general public that is less protected.
We applaud the FDA and CDC for changing the recommendations for children, to reflect the poor efficacy of the live attenuated influenza vaccine (nasal spray). We hope the FDA will continue to look carefully at whether the agency should rescind approval of the flu nasal spray, since it continues to show significantly lower efficacy than the standard flu shot towards certain flu strains.
There is another problem however, that I want to talk about today. The CDC has strongly encouraged patients to use antiviral medications if they get the flu. However, the evidence shows how little benefit Tamiflu offers, as well as significant risks for children.
Tamiflu must be taken within 48 hours of symptoms to be effective, and even then it will only help you get better one day sooner. That would be acceptable if Tamiflu was inexpensive and had no risks. But, Tamiflu is very expensive for many people and does have risks. Patients deserve unbiased information about the risks and benefits, but CDC is providing biased information that exaggerates the benefits and minimizes the risks.
The CDC’s oddly promotional behavior regarding Tamiflu seemed very strange to us, until we read in the BMJ that the CDC Foundation is accepting directed contributions from Roche, the maker of Tamiflu. Those contributions are then provided to the CDC, creating a clear conflict of interest.
Millions of Americans count on the CDC to make health recommendations, and they depend on them to conduct research impartially.
The CDC has been strongly recommending Tamiflu, despite controversy over its efficacy. The FDA and the CDC present conflicting information about the efficacy of Tamiflu in high-risk populations. Tamiflu labels provide FDA-approved information that is starkly different from what is recommended by the CDC. The FDA states that Tamiflu has not been tested in patients with chronic cardiac disease or respiratory disease. However the CDC provides an informational hand out that states in BOLD that if you have a chronic illness such as asthma or chronic heart disease antiviral drugs can mean the difference between a mild illness and a hospital stay. There is no evidence to back up that statement.
Thank you for your time.