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Pharmas Urged to Undertake Further Research Before Marketing Flu Medkits

by Gopalan on October 31, 2008 at 11:07 AM
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 Pharmas Urged to Undertake Further Research Before Marketing Flu Medkits

A US panel of experts Wednesday called upon pharma majors GlaxoSmithKline and Roche to undertake further studies before mass-marketing flu medkits.

Stockpiling flu drugs at homes could give rise to its own quota of problems. Storage might not be appropriate, and misuse could result in resistance, it was felt at a meeting convened by the federal government authorities.


The word "flu" is short for influenza. The flu is a virus which targets the bodies respiratory cells and damages the lining of the respiratory tract, leading to swelling and becoming inflammation of the tract. Influenza spreads rapidly by replicating itself inside the host cell, producing hundreds of copies of the virus in a short period. In approximately an hour the virus can destroy the host cell and propel its replications out into the body to find new host cells. For some people, the flu and its complications can be very serious, even fatal.

The U.S. government is stockpiling millions of doses of antiviral drugs for treatment of the ill in a pandemic. And some states too have bought additional stocks of the drugs. But how those drugs will be distributed when a pandemic hits is a dilemma many jurisdictions are struggling with.

It is expected that doctors and hospitals will be overwhelmed and won't be able to handle an influx of sick people looking for antiviral drugs. And it is thought distribution centres would spread disease at least as efficiently as they spread drugs.

Experts were called up Wednesday for advice on allowing pharmaceutical companies to sell "flu medkits."

"This is a real tough nut to crack for us," said panel member Robert Mauskapf, the director of emergency operations for Virginia's department of health.

He said his state had bought a large supply of antiviral drugs, but so far had been unable to figure out how to close the distribution gap that would be created when doctors were too busy to write prescriptions and emergency departments are "clobbered."

Mauskapf said he thought the medkit proposal might help close that gap.

But many in the panel expressed a range of concerns.

Some worried whether parents would be able to gauge the amount of drug their children would need and mix a solution - by breaking open capsules - based on the child's weight.

Still others wondered the wisdom behind taking prescription drugs out of the hands of medical professionals.

Responding, others pointed out that personal stockpiling of the drugs oseltamivir (Tamiflu) and zanamivir (Relenza) is already taking place. (Roche markets Tamiflu and GlaxoSmithKline is behind Relenza.)

"It's going on already. What we need to do is to figure out a way to do it intelligently," said Dr. John Bradley, director of the division of infectious diseases at the Children's Hospital and Health Center in San Diego, California.

Ultimately the group recommended that the two pharmaceutical companies undertake more research than they have proposed so far.

The companies have been asked to study if people can understand the proposed medkit labelling and could - in the case of Relenza - use the inhaler device needed to administer the drug.

Both companies also proposed to distribute medkits to a number of people with instructions not to use it for seasonal flu. They planned to later follow up to see whether the kits were still intact after one flu season.

The idea of medkits for pandemic flu comes from the doctrine of "shared responsibility," Dr. Robin Robinson, director of theBiomedical Advanced Research and Development Authority, said in an interview.

The U.S. federal government understands, he said, that it cannot meet every need in a crisis. Other parties in society have a role to play.

Robinson likened it to the philosophy of personal preparedness that was espoused in the civil defence programs of the 1950s - a time when people stockpiled food and even built fall-out shelters in anticipation of feared nuclear attacks.

"This is a return to that self-reliance," Robinson said. "Because all responsible officials tell people that the federal government is not going to be able to help provide everything all the time."

"Individuals, local (and) state governments, businesses and the federal government all have roles in this type of responsibility."

Canada does not currently envisage this approach to antiviral stockpiling.

Robinson said he knew of no other country that is pursuing a similar plan, but said other countries are watching the U.S. discussions to see where the debate leads, CBC reported.

Robinson said questions remain to be answered before any decision can be made.

"This is exploratory. This is a concept and we're trying to find the best way. If at the end of the day we can, then we would like to move forward with them in collaboration with physician groups and other health-care providers. And if there's not data there, then we won't go forward with it."

Source: Medindia


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