Archives for November 17, 2005

Vaccines and Legislation

Via CNN: Protection for vaccine makers debated
I think this is completely correct:

Legislation would require proof of willful misconduct
WASHINGTON (AP) — People injured by a vaccine against bird flu or anthrax would have to prove willful misconduct to bring a claim for damages against drug manufacturers or distributors, according to legislation being drafted behind the scenes by Republicans.

A 10-page draft of the legislation obtained by The Associated Press says it would be up to the Health and Human Services secretary to declare that such misconduct occurred. If that declaration is made, the case must be heard in federal court.

The measure, which would be included in a spending bill, would bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages to a maximum of $250,000.

The government has done this before, with the Swine Flu scare (which ended pretty badly for all concerned), and the vaccine manufacturers were very happy they had the legal protection they did.

The draft legislation was provided to the AP separately by two parties opposed to its provisions, who did not want to be identified.

The courage of their convictions is remarkable. It must be incredibly frustrating to work in an environment where trust is just a word on your money.

An aide to Sen. Bill Frist, R-Tennessee, confirmed the majority leader was looking to add the liability protections to a spending bill.

Amy Call said the legislation is important because “it would be a pity to appropriate $7.1 billion to purchase vaccines and antivirals but have no capacity to produce them.”

She said Frist is seeking clearly defined standards for an industry that is already heavily regulated.

“We would only provide liability protection in a serious situation and for a set period of time and for a specific purpose,” Call said. “The protection would only go into effect if the secretary makes a declaration that we are grave danger and the public is advised to take the product.”

President Bush’s plan for dealing with a flu pandemic called on Congress to give drug manufacturers sweeping immunity against lawsuits. “In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits,” Bush said last month. “Today, there is only one manufacturer in the United States that can produce influenza vaccine.”

Let’s repeat that: there’s only one influenza vaccine manufacturer in the US. Hug a plaintiff’s lawyer if that makes you feel all warm inside.

Lawmakers from both political parties also have cited a need to grant the industry some protections. However, the protections described in the draft are quite broad, and some say they would make it extremely difficult for those harmed by a medicine to get any financial compensation.

Nice little editorialization thrown in pretending to be news, and who is ‘some’? The same ‘some’ who leaked a draft, ‘some’ already defined by their opposition to this legislation? Or the reporter and the mouse in his pocket?

“The Republican leadership in Congress is trying to do another special favor for the drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines, with no compensation for those who are harmed,” Sen. Edward M. Kennedy, D-Massachusetts, said in a statement.

He called for an open debate on the issue.

Dang Republicans, wanting to “do a special favor for the drug companies” like not see them sued out of existence for making a life-saving vaccine at government request. I am all for an open debate on the subject, and a roll-call vote. In two years if there isn’t vaccine and there is a pandemic, let’s have a full record so the survivors know who was responsible.

And, the vultures are unhappy:

Trial lawyers said they oppose having to prove “willful misconduct” to get financial compensation from an injury.

Yeah, shouldn’t emotion be the determining factor? It doesn’t matter that the vaccine company worked their tails off to produce a vaccine for a deadly disease on a tight deadline, if there is an adverse event, let’s sue!

“Basically, as an average person, I would have to prove some scientist at Merck or some CEO somewhere had made a determination to hurt me,” said Chris Mather, a spokeswoman for the Association of Trial Lawyers for America.

Willful misconduct, according to the draft legislation, would occur if manufacturers or distributors of a particular product knew that it presented “a significant or unreasonable risk to human health” and there was a “conscious failure to act” to avoid that risk.

If the HHS secretary rules against the petition, then those claiming to be harmed could seek judicial review from the U.S. Court of Appeals.

Unless there are legal protections, there won’t be a product to worry about, so all that is moot.

Rep. Dave Weldon, R-Florida, a doctor who said he is involved peripherally in the talks, said he doesn’t want protections so broad that people might be unwilling to take medicine in the event of a flu pandemic.

“The way it’s being discussed is lacking,” Weldon said.

I have to assume the reporter nodded off there, and didn’t write down the rest of Dr. Weldon’s sentence, as what is there doesn’t make much sense.

Unfortunately, this is the wave of the future, getting legislation passed to protect us from the legal wolves who would gladly devour us all.

BBC NEWS | Health | Decaf coffee linked to heart risk

via BBC NEWS | Health:

Drinking decaffeinated coffee could increase the risk of heart disease, a study has suggested.
It could lead to a rise in harmful cholesterol levels, the US National Institutes of Health study found.

Stick to the leaded stuff.

Unless you’re pregnant:

The finding comes as a Danish team reiterated that drinking eight or more cups of coffee a day while pregnant may double the risk of losing the baby.

They advised pregnant women to drink no more than three cups of coffee a day, in line with existing UK advice.

As I’ll never be pregnant, I’ll have another cuppa’.