More than one political pundit has deemed our current time as the Information Age. We're constantly inundated with data - some mundane, some crucial, much of it not-quite-so-accurate.
In the medical arena, omitting information or disseminating partial or inaccurate info can be annoying at best, fatal at worst. In an effort to try to keep the public better informed about drug safety issues, the FDA is preparing to launch a new Drug Watch webpage. Likewise, to combat the myriad of websites that contain false or misleading information about vaccine safety, the World Health Organization (WHO) has created a list of 23 websites that it considers "reliable."
The FDA recently issued its Draft Guidance regarding Drug Watch, and there are still about 85 days remaining to send in any comments you may have regarding it to the agency. According to the Draft Guidance, the Drug Watch page is meant to display drugs for which the FDA is actively monitoring early safety signals and is not supposed to be a list of drugs that are particularly risky or dangerous for use. The Guidance notes that while sponsors of trials may readily have information that indicates a potential risk with a drug, health care professionals and patients have not always received this information. The Drug Watch page is meant to be a vehicle for that information, so everyone can see what might be an issue with a drug and what the FDA is doing about it.
The newly minted Drug Safety Oversight Board (DSB) will be the conduit to getting the information posted on the page. The Guidance states that the Board will likely perform a preliminary analysis to " determine that the new safety information is sufficiently credible to warrant public dissemination."
This is certainly a great symbol of the FDA's desire to get more information into the hands of patients and their health care providers, but the devil is still in the details. There are still multiple layers of people that information has to get through before it's even considered for the page - through the labs, the researchers, the particular Office and then to the representative from that Office to the DSB, which will need to meet and discuss whether to post the information. I'm assuming (a dangerous occupation, but I like to live on the edge) that one sort of problem this webpage this is meant to address is the "Vioxx Dilemma," where some researchers at FDA had thought for a while that Vioxx and other Cox-2 inhibitors could be dangerous, but they were silenced by their superiors and allegedly prohibited from saying anything about it. Thus, in addition to having the Drug Watch page, hopefully the FDA is also getting serious about cracking down on the behavior the superiors allegedly took part in, as it's all well and good to have the DSB there but it doesn't help at all if researchers have to get through red tape or feel like their job is threatened if they pipe up about a potential issue.
The Guidance also says that the FDA will inform sponsors that their product will be on Drug Watch shortly before actually placing it there. While it's good to provide notice of that (sheesh! can you imagine being blindsided with that?!?), the consumer advocate side of me hopes that sponsors are able to substantially delay the publication of information on the site by asking for time to somehow correct the issue beforehand. In some cases, allowing for corrective measures will make sense but it will also undermine the public confidence in Drug Watch if it looks like the FDA is still working too closely with sponsors.
The preceding probably makes it sound like I'm anti-Pharma or that I distrust pharma/biotech companies. That really couldn't be further from the truth. From listening to friends and family, though, it's clear that Pharma/BigBio needs to really step up to the plate and do what it can to help restore faith in their own companies and the system. So I'll just issue my small plea to those companies to simmer down and re-evaluate strategies that make it look like you're hiding bad information.
Turning to the WHO site, I think it's a terrific idea. There are a lot of websites out there with half-truths and superstitions abounding regarding vaccines and their effects. Here is the list of sites that the WHO currently deems acceptable as meeting the "essential and important good information practices criteria":
- Asociación Española de Vacunología
- Catalogue et Index des Sites Médicaux Francophones (CISMeF), Centre Hospitalier Universitaire de Rouen
- Childhood Immunization Support Program (CISP), American Academy of Pediatrics
- Department of Health, United Kingdom of Great Britain and Northern Ireland
- Division of Viral Hepatitis, United States Centers for Disease Control and Prevention
- Global Advisory Committee on Vaccine Safety (GACVS)
- Health Protection Agency, United Kingdom of Great Britain and Northern Ireland
- Immunization Action Coalition (IAC)
- Murcia Salud
- National Immunization Program (NIP), United States Centers for Disease Control and Prevention
- National Network for Immunization Information (NNii)
- National Vaccination Programme of the Netherlands
- Network for Education and Support in Immunisation (NESI)
- Network Italiano dei Servizi di Vaccinazione (NIV)
- PATH's Children's Vaccine Program (CVP)
- Public Health Agency of Canada
- Robert Koch Institute (RKI)
- Sabin Vaccine Institute
- Vaccine Education Center (VEC), Children's Hospital of Philadelphia
- Viral Hepatitis Prevention Board (VHPB)
The WHO will re-evaluate each of these every 18 months.