Reply #6: knr - Also, Senate HELP amendment on "data exclusivity"

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

Executive Session on the Affordable Health Choices Act
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.


...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.


Comment:
By Don McCanne, MD

"...Last evening’s session devoted to the data exclusivity amendment was the longest amount of time they spent on any issue in the reform legislation. I stopped my other work to watch it. This morning, I’m not only jaded, but I’m also depressed. I’ll tell you why.

Earlier in the day yesterday, I sent out the following quote from Bill Moyers: “Nothing will change — nothing — until the money lenders are tossed out of the temple, the ATM’s are wrested from the marble halls, and we tear down the sign they’ve placed on government — the one that reads, ‘For Sale.’”

I didn’t sleep last night. Instead of counting sheep, I kept watching, in my nightmare, each of those Senators who voted yes picking up their bundle from the ATM machine in the marble halls on their way out as they passed the “For Sale” sign at the door.

But this isn’t about my nightmare. It’s about the 307 million of us who are the merchandise in Congress’s rummage sale. That’s why I’m depressed."