Reply #55: Senate HELP amendment on "data exclusivity"

[slipslidingaway]

We should be questioning relationships between politicians and the firms that represent the corporations for additional profits.

http://www.pnhp.org/news/2009/july/senate_help_amendmen...

"U.S. Senate HELP Committee
July 13, 2009

Consideration of the Enzi/Hatch/Hagan amendment on establishing a data exclusivity period of 12 years for biotech innovation

Sen. Orin Hatch: I don’t know a biotech company that isn’t for this bill, for this 12 year data exclusivity.

...Sen. Tom Harkin: Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is.

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Sen. Bernie Sanders: Let’s find out why year after year the drug companies make hugh profits, look at why the drug companies have never once, to the best of my knowledge, have never lost a political debate here in Congress… (medicine) doesn’t do anybody any good if they can’t afford it. I think for year after year we’ve been paying a lot of attention to our friends in PhRMA, who are spending, I don’t know what they spend in lobbying and campaign contributions, a whole lot of money. Maybe it’s time that we start worrying about the people who have to pay for this medicine.

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Sen. Sherrod Brown: You know what we’ve not talked about, Mr. Chairman? We’re not talking about how much these biologics are costing patients. Let me give you some numbers. (examples)… 48 thousand dollars… 20 thousand dollars …100 thousand dollars. You know what the average wage in my state is? 46 thousand dollars… If we do this giveaway to the drug industry, this giveaway to the biologic companies, it means profits are up for them, it means executive salaries are up for them, it means we can all feel good, but let’s think about the patients, let’s think of the patient with breast cancer who has got to spend 1000 dollars a week… the patient with colon cancer who’s got to spend 2000 dollars a week… What kind of progress is that, Mr. Chairman?

The data exclusivity amendment passed by a vote of 16 to 7, with several Democrats voting in support..."


Biotech firms lobby for say on healthcare

$66m effort to protect drug-patent exclusivity

http://www.boston.com/news/health/articles/2009/07/21/b... /


"...The quest for influence is not always obvious.

Howard Dean, the former Democratic Party chairman, wrote an opinion piece this month in The Hill, an influential Capitol Hill newspaper, arguing that fewer than 12 years of monopoly rights for biotech companies’ products “would prematurely rob innovators of their intellectual property and . . . destroy incentives to develop new cures.’’

Within hours Joe Trippi, a Democratic consultant who ran Dean’s 2004 presidential race, hyped Dean’s opinion piece in a blog post that he sent to The Huffington Post, a widely read website. “He’s a doctor and lifelong advocate for health reform - he knows what he’s talking about,’’ Trippi wrote, urging readers to contact their lawmakers.

...Dean failed to note in his editorial that he is an adviser to McKenna, Long & Aldridge, a global law firm that is advising the Biotechnology Industry Organization, the influential trade group.

...But Dean said his editorial was part of McKenna’s rapid-fire response to an unexpected, eleventh-hour Senate health committee proposal (which biotech firms ultimately fought off).

“It was a huge scramble, all hands on deck,’’ Dean said..."