Wednesday, June 11, 2008

Virologist Disagrees With HHS Proposed Antiviral Guidelines

 

# 2062

 

 

 

The release of the Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic  and Proposed considerations for antiviral drug stockpiling by employers in preparation for an influenza pandemic last week was intended elicit public comment prior to adoption of these guidelines. 

 

Today we have one very long response from Dr. Graeme Laver of Australia, who believes that outbreak prophylaxis, and personal stockpiling of tamiflu are bad ideas.

 

Needless to say, the doctor and I differ on several points, although I applaud his call for making Tamiflu available without prescription. 

 

This is just a snippet of a much longer article, follow the link to read the whole thing.

 

 

Prophylactic Use of Tamiflu Bad Idea, Leading Virologist Says

by Anthony L. Kimery

Tuesday, 10 June 2008

Early treatment is the only way to go

 

The US government’s new proposal to use drugs like Tamiflu and Relenza as a prophylaxis to prevent infection by a pandemic strain of influenza is wrongheaded, says Dr. Graeme Laver, a former professor of biochemistry and molecular biology at the John Curtin School of Medical Research at the Australian National University in Canberra.

 

Laver, who played a key role in the development of both drugs, has been studying influenza viruses for nearly 40 years. He and Dr. Robert Webster (another world-renowned virologist at St. Jude Children’s Research Hospital) are credited with having first found the link between human flu and bird flu. In the 1960's, both received world acclaim when they developed a new and innovative generation of vaccines for flu viruses.

 

Laver told HSToday.us that “prophylaxis with Tamiflu in a pandemic is wrong. Early treatment is the only way to go.”

 

But the US government proposes to use Tamiflu and Relenza prophylactically to prevent infection, including giving guidelines to businesses that may want to buy the drugs in advance to treat or protect employees.

 

The Department of Health and Human Services’s (HSS) pandemic plan calls for “targeted antiviral prophylaxis … of disease clusters, administration of antiviral treatment to persons with confirmed or suspected cases of pandemic influenza, and provision of drug prophylaxis to all persons in [an] affected community.”

 

Similarly, should clusters of humans be found infected with a virulent strain of influenza like H5N1, the World Health Organization's plan of attack is to flood the regions with Tamiflu in the hope that it will quell further spread of the virus.

 

Dr. Ben Schwartz, a pandemic planner at HHS who wrote most of the new guidelines, told Reuters that "for prophylaxis of health care and emergency services workers, the responsibility for purchasing and stockpiling the drugs would primarily be on the health care organizations ... or on the emergency organizations that would be protecting their workforce.”

 

Meanwhile, HSToday.us has learned that there also are discussions within HHS about making Tamiflu and Relenza “push packets” available to people to have on hand in the event of a pandemic.

 

Laver also has problems with that notion.

 

“Personal stockpiles of Tamiflu or Relenza are not a good idea,” Laver told HSToday.us, explaining, “personal stockpiles are wrong for two reasons. First, nothing might happen and the stockpiles will be wasted and, second, if the stockpiles are used, it will be on the basis of self-diagnosis, and that is not a great idea.”

(Cont.)

 

 

Health care workers who will be in direct contact with infectious patients run a terrible risk of contracting the virus.  Dr. Laver seems to have a good deal of faith that early treatment with Tamiflu can quickly end an infection. 

 

Here is another quote from the article.

 

Laver also said “using a rapid flu test to assist this would be a good idea, so that people who think they have the flu can be properly diagnosed quickly and take the drugs very soon after symptom onset. This rapid procedure of ‘test and treat’ would mean that the infection should be immediately terminated and the flu victim experience a quick recovery. Seems quite simple, really!”

 

 

Perhaps, but we haven't seen very many `quick recoveries' thus far. 

 

One could argue that up until now most bird flu patients haven't received the drug early enough - and that might well be true - but we don't have a lot of evidence that Tamiflu administered early will be a panacea for pandemic influenza.

 

 

Health Care workers, particularly those with families, are going to have a difficult choice deciding whether to work during a pandemic.  Roughly half of those polled  have indicated they might not risk exposure.  

 

 

Making prophylactic antivirals available, along with adequate PPE's (masks, gowns, gloves) would go a long way in convincing many HCW's to work. 

 

We've no idea, of course, how effective outbreak prophylaxis will be.   It has been a rare occurrence that cullers, taking prophylactic Tamiflu, have contracted the virus.   That would seem to be a good sign.

 

 

As far as individual stockpiling of antivirals is concerned, Dr. Laver admits that the critical time period to begin treatment once symptoms appear is short.

 

 

To work, Tamiflu must be taken in proper doses within 6 to 12 hours after onset of symptoms.

 

"Forty-eight hours is about the limit the drug is effective," Laver said.

 

 

One would have to have a good deal of confidence that governments can get antivirals into the hands of those infected within 12 hours of the first symptoms appearing to reject the notion of personal stockpiling.

 

In a mild, or even moderate pandemic, that might be possible. 

 

No one knows how our infrastructure will handle a severe pandemic.  There are genuine concerns about supply chain failures, social disruptions, and even temporary outages of essential services.  

 

How efficiently antivirals can be distributed to individuals under those circumstances is an open question.  

 

 

This debate over the use of antivirals during a pandemic is long overdue. 

 

The concerns raised by Dr. Lever are not without merit, and his call to make Tamiflu an O-T-C med is laudable.   But I strongly disagree with his stand against prophylactic antivirals for HCW's and first responders.  

 

They will be on the front line, and deserve all the protection they can get.

 

Hopefully others will weigh in on this issue over the next few weeks.   The public is encouraged to comment on the proposed guidelines for antivirals and for face masks and respirators. 

 

Information on how to do so is presented  here.