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I’d agree that the House bill is superior on most points, with the exception of abortion and the funding mechanism (the Senate’s excise tax on expensive health plans makes considerably more sense than the House’s millionaire’s tax). Nevertheless, one thing that strikes me is that the Senate and House bills are more similar than one might expect after these months of political wrangling. (The major point, of course, is the lack of the public option, but the Senate requirement that at least one of the plans in the exchange be operated on a non-profit basis at least tempers the argument that all this bill is doing is pumping up insurer profits.)
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p>Also, without going into all of this again, it is clear that it is not as easy as simply using reconciliation to pass the bill in the Senate — due to the fact that parts of it would have to be split off, that they would likely have to include a sunset provision, and (probably most importantly) that for whatever reason, reconciliation does not seem politically possible (since not only the “moderates” but some liberals in the caucus, like Sen. Feingold, might defect from the straight-up 50-vote requirement because of concerns that reconciliation is abusing the process). That’s what makes it difficult to separate whether Reid is simply unwilling to use reconciliation, or whether he is unable to do so. That’s not entirely clear, though I’d argue the weight of the evidence is on the latter possibility.
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p>That said, I’d return to the point that if you were to look at just the Senate bill, it would be the most significant progressive advance in health care policy since 1965. At the very least, whatever House provisions are not included in the final bill can and should be the starting point of negotiations for improving this bill in the days, months, and years ahead.
Has he really said anything like that?
Feingold has expressed great reluctance to use reconciliation for health care reform, though I don’t know if he’s said anything about it since April. His relevant statement from April of this year is located here (this is taken from his Senate floor comments, available at Project Vote Smart and thomas.loc.gov). The key passage is the following:
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p>I don’t know whether Feingold still sticks to this, but I would not be surprised if he did (he tends to stick to his “use the right process” guns). I guess the key is whether there are other Feingolds in the caucus, attacking the use of reconciliation from the left.
Be altered to accomodate the Senate, but the Senate will give no ground?
I’m not sure if the Senate will give “no” ground, but I suspect that any ground it does give up will only be around the margins — the final conference report will certainly look more like the Senate bill than the House bill, and not just on the public option.
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p>Still, these “margins” might be of some importance, such as the level of subsidies and (less likely) the better employer mandate language in the House bill.
that, if Reid decided to try to ram through a more progressive health care bill via reconciliation, Feingold would stand in his way. He might give lip service to some procedural discomfort, but no way would he actually try to obstruct the bill.
what do you make of COBRA? That was a reconciliation bill, and it’s as much a hodgepodge as the current health care bill; I’m hard-pressed to see how COBRA’s hallmark requirement of employers extending health coverage is any more budget related than the preexisting condition rule (if anything, it’s probably less so, since the amount of federal subsidies will be affected by any change to insurance regulation). Is the Byrd Rule the reason COBRA could pass via reconciliation but, in your view, the current health care bill couldn’t?
I think the COBRA example illustrates that while the use of reconciliation for the current health care bill is much more problematic than many public option advocates suggest, it is not technically impossible. Indeed, if I remember correctly the Byrd Rule DID apply to the COBRA legislation — in fact, it was the first bill to which it applied. So you are right that it is not impossible, and to that degree your COBRA example is on point.
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p>However, there are some key differences between now and then. First, the COBRA legislation had, I believe, more support in the Senate than the current bill, which is possibly one reason why the newly enacted Byrd Rule was not invoked in that case. (In any case, I have no doubt it would be invoked here.) Second, the Byrd Rule itself has undergone some changes since 1985/1986, including making its application more broad.
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p>Third (and most importantly), it is an incredibly risky maneuver to use reconciliation on a bill such as this, for two reasons. First of all, it is likely that the Senate Parliamentarian would rule to exclude several portions of the bill under the current Byrd Rule. Indeed, I think it likely that Reid already has received preliminary word from the Parliamentarian on this point. While true that, technically speaking, the Parliamentarian’s ruling is not binding on the Chair, I am not aware of any case when the ruling of the Parliamentarian (a highly respected and professional figure) was not upheld. Doing so would mark a major shift in the operations of the Senate. Perhaps this would be a good thing, but it would also open a Pandora’s Box far larger than the health care bill itself. I’m not surprised that Reid has little interest of going in that direction. I also have my doubts that any other potential Senate Majority Leader — Schumer, for example — would make a different choice here.
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p>Second of all, there’s the problem that such a major Senatorial change might lead several Democratic Senators to defect from the vote on a reconciliation bill. Certainly we know of Lieberman and Nelson (who will not go along with a public option). However, other moderates such as Lincoln and Landrieu are unlikely to go along either — especially when they have the cover of other anti-reconciliation Democrats. There are likely other potential problems out there that for one reason or another haven’t been as prominent, but would be if reconciliation were used (Sen. Dorgan or Sen. Webb, as possible examples). Further, while your point about Feingold above is well-taken, I’m not so sure that he in particular would back down from his concerns about the use of reconciliation.
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p>In any case, I’m not sure about whether Reid has the 50 votes necessary to pass a reconciliation bill with a strong public option, but I wouldn’t be entirely surprised that he doesn’t, or that it is too close for comfort. At the very least, the use of reconciliation would splinter the caucus in a way that would either damage the possibility of any reform now, or else make it much more likely that any ideal bill is gutted in the future (with newly elected 2010 Republicans teaming up with the Nelsons and Liebermans to achieve 60 votes to alter the bill before the key parts ever go into effect).
You’re making excuses for Reid. If it’s “not technically impossible”, and a similar thing has been done before, then why on earth shouldn’t it be attempted here? Etiquette? Does anyone think the GOP would hesitate to use any and all tactics at their disposal to advance a measure they value to a similar degree, or to block one that they find sufficiently offensive?
a forgone conclusion already? Yikes!
I guess you’re saying we lost a few seats already, and they will assume office in January. How many did we lose?
Sorry for my ignorance.
…we will probably lose a few seats in 2010 as the WH party usually does. I don’t know when we might have 60 Senators again, even on paper, and I do think we squandered some opportunities here.
History suggests very strongly that Democrats will take some losses in 2010. Still, I’d agree not to concede anything at this point, and I have confidence that Democratic leaders are conceding nothing either.
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p>However, I think it’s fair to be realistic about the future. We won’t always have 60 seats — and probably not after 2010 — so we have to think about the long-term viability of the policies we enact today.
That’s a fair point. The question, really, is whether Reid — and Obama — are willing to go to the mat for a more progressive bill. Sadly, most of the commentary emanating from the White House suggests that that’s not the case. Obama seems content to get more or less what’s in the Senate bill, and having declared victory on getting the Senate bill passed, it would be hard for him to pivot now and declare that only the House bill is good enough. So Reid can’t get the backup he’d need, even if he was inclined to try (and on what Reid really wants, I have no idea).
Apparantly high marks in the “plays well with others” column. Has anybody ever heard him speak passionately or raise his voice about anything? I haven’t.
…from a state that’s purple at best. We need a Majority Leader whose personal seat is safe if we want to really move, IMO.
that Farnkoff makes, and I don’t dispute that the Republicans are willing to play faster and looser with institutional rules, for better or worse.
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p>However, my point is simply that it is considerably more difficult to simply “use reconciliation” on health care, as some progressives have suggested, than it is in practice. I’m decidedly not an apologist for Reid, who is considerably weaker than Pelosi as a leader, even grading on a scale to account for the substantial institutional differences between the House and Senate. I don’t even deny that Reid (and Obama) could have likely done more in this whole process.
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p>Nevertheless, I’m not so sure that they could have done all that much more, and I’m also doubtful that some of the suggestions would have made any difference at all (for example, Obama barnstorming in Maine against Olympia Snowe, which someone suggested on BMG…does anyone seriously think this would have mattered?).
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p>Indeed, the only way to get a better bill probably is through reconciliation, but because (1) the chances of success would be remote for the reasons I’ve stated here and elsewhere and (2) the ultimate (reconciliation) bill, even with a public option, might be weaker because of exclusions, sunset clauses, or because the bill’s future support would be far more fragile, Reid likely made a reasonable and justified decision in not pursuing reconciliation.
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p>Perhaps Reid erred here, but say that an ideal bill with a strong public option had a 10% chance of passing if reconciliation was used (which is about where I’d put it), and the current bill has a 95% chance of passing at this point, I’d go with the 95% option. I guess the dispute all depends on whether you think that the chances of successful reconciliation are higher (than my 10%, for example) or whether you think that the current bill is not a step forward at all. That’s fine, but I’m confident that the weight of the available evidence suggests that Reid’s decision to not use reconciliation and to get 60 votes for the current bill will be looked upon kindly with hindsight.
What are the quorum rules for votes in the Senate. Can the Republicans go AWOL, and cause the Senate not to have a quorum to have a session and a vote, or is the Democratic majority large enough?
that a quorum is a simple majority.
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p>As I said in my post that you replied to, it is not simply about “etiquette”. It has a lot to do with cold, hard politics. Reid had reconciliation on the table earlier in the process, but dropped it after what I reasonably suspect was a serious political problem — if he used it here, he would lose the votes necessary to pass a reconciliation bill.
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p>It would have been helpful, in hindsight, to get some sort of a grassroots whip count on the question. But to my knowledge we don’t, which is why my reasonable suspicion is nothing more than speculation. But absent additional evidence, I think it’s more convincing than variants on “Reid is a corporate whore” or “Reid is an incompetent, doddering fool”.
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p>However, if any Reid/Senate bill critic were to come up with such evidence, which I have not seen to this point, I’d be glad to reconsider.
It was probably the best bill comparison piece done. And you’re right re: House Bill > Senate Bill.
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p>I think it would be a good use of bloggers who advocate passage of the Senate bill via reconciliation to carefully analyze the rules of budget reconciliation, as well as the likely political moves of U.S. Senators, and offer a demonstration of how we could pass a better HCR bill that way (i.e. a rebuttal of this).
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p>Otherwise, with much due respect, encouragement to use reconciliation sounds uninformed. And criticism of Senate Leadership for not going that route sounds hollow/lazy.
…which I’m still trying to get verification on:
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p>1) Conference reports aren’t subject to cloture rules, thus only requiring only a majority to pass.
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p>2) House and Senate leaders may use a less formal process than Conference to iron out the differences.
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p>Can anybody confirm or deny either of these with any certainty?
that #1 is wrong.
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p>I’ve seen rumors similar to #2, but haven’t seen anything definite.
There are a couple of Congressional Research Service reports that I think answer your questions.
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p>On #1, it is definitely the case that a conference report is debatable and thus subject to the filibuster. Thus, cloture must be invoked to close debate if the Republican are adamant on delay. This is indicated on pages 14 and 15 of the following PDF file: “Filibusters and Cloture in the Senate”.
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p>On #2, there are procedures less formal than a conference committee to iron out the differences. Pages 6 and 7 of the following PDF give some info on this: “Conference Committee and Related Procedures: An Introduction”. The CRS report goes into a bit more detail here, but it does say that
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p>This may be necessary, given that Republicans have a number of procedural ways to mess with the establishment and assignment of a conference committee, if they so choose.
I found in the filibuster report you linked the concept I was refering to. I guess what I had heard was about the privilege to proceed to debate without having to vote on that motion. The report itself may be filibustered.
I have been unable to find this info.
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p>Has the committee been selected? How is this done?
1) Pretty much I agree with the idea that the House bill is better than the Senate bill, though I would add in every respect since I find no objection to Stupak-Pitts. That said, I would also agree that the Senate bill is better than our current status quo in health care and has substantial reforms in several areas that demonstrate this is the President delivering on a campaign promise and will lay the groundwork for pushing public option or even single payer ten or twenty years from now when the country is more progressive (and it will be, as Nate Silver points out) and when the limitations in these reforms start to be born out making the people clamor for more action. The quicker we can pass this the quicker we can pass a jobs package that will be the key to saving the Democratic majority and the Obama administration. So for all those reasons while I am happy with the House, I think we can easily take the Senate and move on to the next fight.
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p>2) Gotta disagree with you David on this point-
. First I am not sure that reconciliation can be used to pass the entire conference report, the way I have read reconciliation rules it can be used to pass the budget/appropriations portions of the bill, which would be passing around 60-70% of it. But the rest of the bill, including key reforms like making it illegal to turn down people with pre-conditions, setting up state based exchanges, and allowing uninsured people to sign up with the Congressional plan (what I like to call the ‘backdoor public option’) might not be covered and thus subject to filibusters and would empower the Ben and Joe even more to stripping the bill of parts they don’t like. All in all it could be a riskier strategy since it would take longer and reduce the likelihood that individual Senators will vote for the portions they don’t like since they are no longer voting up or down on the passage of the entire package.
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p>3) Stupak-Pitts will continue to create problems since it is unlikely the substantially more pro-life Democratic caucus will pass the Senate compromise without Stupak-Pitts and it is similarly unlikely that the Senate will pass the language with Stupak-Pitts so this amendment will continue to cause a lot of trouble, and will unfortunately turn a debate about health care, a debate that should clearly show how out of touch Republicans are and how much Democrats care about people, into a debate about abortion that divides the caucus and get it off message.
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p>I find it highly unlikely that the Democrats will allow the differences between the two versions of the abortion language to sink the entire effort, particularly at this point. (And the fact that the Catholic Church appears willing to pull out the guns to kill health care for millions of Americans because of the difference between the two abortion clauses is another reminder why I am a “lapsed” Catholic…). This is one area where anti-Stupak-Pitts members can and should stick to their guns, because here (unlike with the public option) those members have more leverage here. The bill is much more likely to pass with the Nelson language than with the Stupak language.
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p>Also, I agree wholeheartedly with your first two points, by the way.
Stupak Opposes Senate Compromise – Dec 21
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p>41 of 64 Stupak Amendment Yea votes voted Yea for the House health bill but only about 12 of the 41 might vote against a Conference bill without Stupak language.
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p>So it seams the WH does engage individual members in Congress on matters it deems important.
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p>How about a Dem Congressman refusing to meet with the WH?
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p>True, he’s secure in his seat and can afford to rebuff his own party but why is it to his advantage?
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p>(Why, if the WH favored the Public Option and Medicare expansion, would it not have asked Lieberman to come to the WH house for a meeting and spoken to him to ask him to refrain from speaking about the topic? Clearly it was of little concern to the WH, or if not, it was the bill they wanted one w/o the public option and medicare expansion, or as a third possibility, they forgot about the issue altogether.)
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p>Given the insignificant whip count of house members who would reject a conference bill without Stupak-like language, what’s driving this issue? A sense of moral justice? The procedure cost about $400. Stupak simply makes it unavailable to people who can’t afford, beg, borrow or steal $400, the least resourceful among us.
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p>God help us all from the tyranny of the righteous god-fearing righteous.
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a good read:
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p>Stupak claims to have 10 no health care votes unless it has Stupak Amendment language that restricts insurers who cover abortion from getting federal aid (as opposed to insuring no Federal dollars are spent on abortion services.)
I really see little difference between the language. The original point of the Stupak Amendment was to drive the debate rightward, ensuring that leftist efforts to create a back door around Hyde were defeated, this drive succeeded (thank God) and Hyde is preserved. The Nelson bill ensures that no federal money will fund health care coverage for abortions-the status quo, Stupak goes further and makes it illegal to purchase health care insurance that covers abortion, but instead creates a separate abortion insurance that people have to buy. As a pragmatic pro-lifer who recognizes that Roe is not going away and this fight can only be won through grassroots persuasion and funding full alternatives to abortion, I really don’t see why Stupak is insisting on the fight. He succeeded in forcing the powers at be to insert specific language maintaining the Hyde Amendment. The Senate language can pass the House, Stupak cannot pass the Senate, so its not a fight he can win-without dragging all of HCR down with it-which would likely increase abortions since he a)doesn’t even get a legislative victory and b) doesn’t get HCR passed-which would reduce unwanted pregnancies significantly. So not only does this bill save no unborn babies, it would also prevent millions of people from getting health care coverage. Like a Coakley of the right, Stupak does not seem to understand that in order to get things done in DC you need to compromise, and that fighting this fight to the bitter end won’t result in anything but major losses for every American.
I was under the impression that this went a lot further than simply maintaining the Hyde Amendment. If that’s all they wanted to do they could have just added a clause saying, “Nothing in this legislation shall be construed to negate or weaken the provisions of (insert the official US Code citation commonly known as the Hyde Amendment)”. Doing simply that probably would have generated little controversy.
I meant to say that Nelson’s Senate language maintains the Hyde Amendment while Stupak-Pitts goes a bit further. And to me, while I agree in principle that going further would be nice, I completely disagree that restricting such a marginally insignificant number of abortions is worth jettisoning health care reform over. Do you think the Nelson language goes beyond the Hyde amendment? I thought it simply reiterated that no federal funds will directly fund abortions through the subsidies provided through the exchange.
Enough with the campaign promise BS. We heard plenty about ending wars, public options, transparency, stimulus spending, bipartisanship, etc. during the campaign. And all of it has been proven to be hot air. Furthermore, if you really believe that the current health plan paves the way towards a public option why aren’t the Democrats saying it. I’ll answer that. It’s just another example of the Democratic Party being disingenuous with the American People in both its methods and its ultimate intentions.
Please tell me how this isn’t a violation of the AP’s copyright.
… is that you can’t take the whole thing.
I think a graphic is probably fine as long as it is duly cited.
… but no. Not online. I would add that you have some mighty peculiar ideas about fair use.
…but I’m pretty sure I’ve seen graphics lifted from one publication to another with proper citations. I’ll let the diarist defend himself further.
And many of them are copyright violations.
is a standalone piece which was compiled by AP, and then reformatted by the Globe. I found the Globe’s reformatting to be a far superior way of presenting the info, which is why I used it. However, in response to Dan’s copyright point (which I thought was well taken), I’ve secured a license from AP to post the piece in its original form, as you can see above at the end of the post.
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p>Interestingly, the Globe’s online version of the chart fails to credit the AP, and therefore probably constitutes some sort of violation, even though the Globe no doubt has a license to republish AP material, since I assume the license requires that AP be appropriately credited. To just look at that version, you’d assume it was compiled by Globe staff, and that’s not the case.
a person can go through 16 years of education in the US and not have one course in which the fair use doctrine is taught. It seems like a failure of journalism, as a profession, to me.
not a journalistic one. And, unfortunately, it’s not a terribly well-defined one, especially in the age of blogs, hyperlinks, and aggregators. Most “fair use” issues in these new contexts have not been addressed by the federal Courts of Appeals; none of them AFAIK has been addressed by the Supreme Court. Presumably that will change sometime reasonably soon; until then, we are all reduced to trying our best to apply 19th-century concepts in the 21st-century. Wikipedia’s article on fair use is quite good.
David: Good for you for getting permission from the AP. And that is hilarious that the Globe didn’t credit the AP online — although, as you note, the Globe pays to run AP material.
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p>We do not have to go back to the 19th century for guidance on fair use. The copyright law was rewritten extensively in the mid-1970s, leading to a four-part fair-use balancing test that is well described in Harper & Row v. Nation Enterprises:
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p>http://bit.ly/7TK3By
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p>The Citizen Media Law Center offers a guide to copyright and fair use that is probably more useful to bloggers than Wikipedia:
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p>http://www.citmedialaw.org/leg…
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p>Though fair use has always been a fuzzy concept, it has never extended to copying all of something. The courts look at the “amount and substantiality” of what was taken. If it was the best and most valuable part, even if just a small excerpt, then that weighs against fair use. (That’s what the Harper & Row case is about.)
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p>Finally, I want to assure Neil Sagan that you can’t go through a college or university journalism program – at least not a good one – without getting into a fairly extensive discussion of fair use.
17 USC 107, was intended simply to codify existing common law which had in one form or another been around for centuries, but appeared most recognizably for the first time in 1841. Wikipedia:
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p>Finally, though they are rare, there are instances in which copying entire copyrighted works has been deemed “fair use.”
but you bet your ass they teach students about it in journalism classes.
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p>Heck, the full name of the AP’s own stylebook is “The Associated Press Stylebook and Libel Manual.” And the “libel” part is not “how to,” either.
Point taken. That said, more than before every American who posts online is in a position to comply with or violate copyright protections and more than before there is a need to educate Americans how to comply with the law … which could be accomplished as part of a public education. Teaching it to journalists in training only won’t get it done.
At least it did for me. Every year of high school we had a major research paper for English class and we spent lots of time on the rules of citation. It was impressed upon us how grievous a sin it was to have even a single phrase worded the same way as a sources and penalties included a grade of zero and expulsion for not dotting every i and crossing every t in this regard. The teachers seemed to care more about this than the substance of what he had to say which was very backward priorities, IMO. We were taught the MLA method of citation and may Heaven help the person who neglected to internally cite an idea that came from another source, however indirectly.
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p>My own personal opinion is that making money should be the standard. In other words, if I’m not making money off it (or somehow preventing the creator from making money off it) then no harm, no foul, IMO though I do think citing (and linking if online) is appropriate. The teachers said it was “stealing” just like theft of physical property, but intellectual property can’t be taken from you that way. If I break into your house and steal your stereo system, the problem with this scenario is not that I now have a stereo since I could have obtained one legitimately. The problem is that you don’t have your stereo which you paid for and thus you have lost something by fraud. The same cannot be said of intellectual property. I can’t tear open your head and physically remove the idea from your brain so that you know longer remember it and have access to and use of it.
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p>This isn’t to say I don’t believe in patent and copyright protections; I absolutely do, but the chart in this diary which prompted this discussion is something that I cannot fathom either the AP or the Globe losing anything by the fact that it was posted here. In most cases, giving credit where credit is due should be sufficient if no money is involved.
is people visiting their site, increasing their traffic, and looking at their ads, instead of visiting this site, increasing our traffic, and looking at our ads.
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p>That’s why I can solve the problem by posting a version of the AP story that includes AP’s ads.
6’s for you.
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in an academic setting is not really bad? That the standard should be “making money” and that taking credit for work that is not yours is somehow not much of a big deal? How about “making” an A that isn’t based on your thinking or writing? That doesn’t bother you?
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p>I have to be misreading what you are saying.
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p>You may not be able to break into someone else’s brain and “steal” an idea, but you certainly get be given credit for something that is not yours, and while that is “stealing” in a metaphoric sense, it is theft nonetheless in a meaningful sense.
I do believe the plagerism is wrong, but believe the grade should reflect that and not expulsion. I also believe it is appropriate to teach and use proper methods of citation. It’s mostly a punishment fitting the crime thing and it just felt to me at times that teachers were blowing it all out of proportion in their lectures about it. Fortunately, it didn’t end up causing me a whole lot of trouble, just an occasional note from the teacher circling something I wrote saying “This should have been cited.” Of course some teachers also seemed to assume that every original thought had an outside source and that we could never come to a conclusion about the evidence on our own.
I’m not a lawyer and I don’t play one on television.
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p>The street wisdom, right or wrong, is that it ultimately depends on the copyright owner. If the owner has no problem, than you have no problem. The legal questions arise after a dispute. The consequence, in the segments of the business world I’ve seen, is that you exercise reasonable judgment in using material from the web. If you have a doubt, ask. Most sites have a terms-of-use agreement — read it. If a company complains, you immediately take down the offending material. Most often, the rare copyright owner who has a problem is perfectly happy with a modest financial settlement. No company or client I’ve ever been involved with has needed that.
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p>That seems to cover about 90% of the cases (including this one, especially after David’s smart and cautious follow up). The other 10% are why God gave us attorneys.
It seems to have quieted down some, but for awhile it seemed like record labels were bent on prosecuting every teenager or college student who shared a music file with a friend. In most cases the “offenders” probably thought nothing of forwarding things via email as it felt to them like they were just allowing a friend to borrow (or even have as a gift) a CD that they owned. Sometimes we have to take a hard look at the consequences of law. This reminds me of the bruhaha a while back about deleting public emails. On the one hand there is a hardnosed rationale for the law, but on the other hand it causes one (me at least) to roll my eyes and think this is ridiculous!
My first high school mock trial case was over the fair use doctrine. My side argued that my client, as a professor, fell under it because he was using his copied CD for educational purposes, the plaintiff argued that he violated their copyright. The case hinged on how we interpreted the fair use doctrine and its educational clause, since it was a civil case we were on the shakier legal ground since we had to prove that our client’s private use was still for educational purposes. Had it been a criminal case, aka beyond a reasonable doubt, it would have been a lot easier to defend.
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p>Anyway I knew that this case would come in handy someday!
I hope you learned that educational purpose cuts in favor of fair use but does not settle the question. By far the most important of the four-part balancing test is whether the re-use somehow takes money out of the copyright-holder’s pocket.
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p>A number of colleges and universities have learned this to their chagrin in recent years. A university, after all, is a non-profit organization engaged in education. Why can’t it just photocopy textbooks? The answer, obviously, is that such an activity would not fall under fair use because it deprives textbook authors and publishers of their rightful compensation.
thank you dkennedy
Both bills say they will cover most Americans (94% and 96%) but both bills also have mandatory coverage (100%). Who are the people who won’t be covered (6% and 4%) and how do they avoid the mandate? Are these the people which are assumed to be paying the opt-out fine?
I assume that will encompass people who don’t qualify for financial assistance but who still can’t pay for insurance, and perhaps also people who do qualify for some help but still can’t afford it. And apparently that’s anticipated to be roughly 5% of the population.
Lawrence O”Donnell are saying the Democratic Senators are lying by touting the healthcare bill as “universal healthcare”. How would the “public option” being included in the bill have filled this gap between the financial assistance group and the people who could afford it group? Would they just raise the “financial assistance” threshold?
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p>I think there will be far more than 4-6% of people who will opt-out of coverage. MA says we have 92% coverage (or 8% who are not covered) and I know t sounds elitist but I think the average MA resident may be more inclined to get insurance than say Arkansas or Texas.
under these bills, you can’t just “opt out” of coverage, unless by that you mean not buy coverage and pay the associated penalty.
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p>The theory is that the public option would provide an affordable option for people who couldn’t afford a private plan, as well as for people who prefer to buy from the government. Whether it would have worked out that way, we will probably never know, unfortunately.
fall inside or outside of the typical patent period of protection? Seems like a good thing for pharma if it is outside the patent term.
Link
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The short answer is that most products benefit from patent protection and novel biologics that offer new cures benefit from patent protection covering a broad spectrum of inventions ranging from patents on the protein itself, patents on the gene encoding the protein, patents on the methods of manufacturing the recombinant product, patents on the method of identifying the patients for personalized dosing or treatment, and patents on the formulation. The more innovative the product, generally speaking, the stronger the patents and broader the protection. As a result, EPO has benefited from multiple patent protection lasting over 20 years since it was marketed. Just last month, Amgen succeeded in asserting its EPO patent rights against Roche in the US even though it began selling EPO almost 20 years ago.
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p>The problem with the 12 year provision is that it provides exclusivity for market approval, not for innovation or discovery of new cures. In my view, it is a bad think for biotech because pharma will no longer need the competitive advantage of innovative discovery research to cure a disease get market exclusivity with strong patents, and will now just seek to invent the 3rd and 4th version of an existing product with some incremental improvemen. Why invest in a high risk research program when a low risk development effort will provide 12 years exclusivity independent of patent rights?
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p>For more details see: Where have all the progressives gone on the biologics provisions in Health Care Reform
The House Bill is designed to prevent the development of Biogenerics and has the unintended (or perhaps intended) effect of discouraging investment in breakthrough innovative products to cure diseases like diabetes, alzheimers, etc.
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p>See Please let your legislator know we need Affordable Lifesaving Biogenerics
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p>In addition to creating a 12 year period of guaranteed market exclusivity which will discourage innovation and encourage development of life extenstion products — a feature of both the House and Senate bills — the House bill included addtional features designed to prevent investment in and devlopment of safe and affordable generic biologics. Improvidently granted patents cannot be challenged under the House bill until after the 12 year exclusivity period. This adds another 4 or more years of market exclusivity and probably makes it uneconomic to develop these cost saving competitive alternatives. The House bill also prohibits the use of a generic name by a generic biologic, so that unlike drugs, a pharmacist will not have the option for substituting a generic biologic even if it ultimately gets approved. This means that unlike todays generic drugs, the generic biologic will need to be “marketed” and will not offer affordability of generics because of the need to create clinical data and to incur marketing costs.
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p>The House provisions, if adopted, will eliminate this game changing, cost saving opportunity. Generic biologics are estimated to save in the 10’s of Billions of Dollars in the next 10 years, and far more as biologics become an increasing share of pharmaceutical products. This is the last chance to encourage our legislators to do the right thing on this issue.
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p>Bruce
Small molecules are relatively straightforward to develop into generics because it is usually necessary only to demonstrate bioequivalence to the original drug. (That is, the generic must be formulated in a way so that in humans it produces a similar relationship of dose to plasma concentration as a function of time).
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p>On the other hand, biologics carry a small but real risk of provoking immune reactions against their respective native proteins, and this can be unpredictable and contingent on additives or on the manner in which the drugs are produced. And it is also not something that can be pinned down preclinically.
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p>Not that this should represent a huge barrier to follow-on biologics entering the clinic. Still, a generic protein drug candidate must demonstrate lack of immunogenicity in a rather large number of people before its safety relative to an existing protein therapeutic can be quantified in a meaningful way. And it certainly does not deserve to use a generic name until it demonstrates that level of safety.
This is the argument raised by the brand industry to protect their market share. As a scientific matter, the need for clinical trials is dependent on the development of technology for characterizing proteins and as that science matures, it is likely that that proteins will be as well understood or perhaps even better understood than small molecules. Both the House and Senate Bills allow the FDA the discretion to determine the need for clinical data.
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p>What is interesting is that absent a generic pathway, there is limited incentive to invest in technology to better understand and characterize proteins because brand companies do not want to know that their new production facilities produce different products than their original facility. Biotech companies that are developing the next generation of characterization technology, in order to understand the immunogenicity or proteins, are potentially going to be better able to reduce the risk of immunogenicity which as you note is a rare event and very unlikely to appear in a clinical trial. By being able to see and control for glycosolation of proteins, one will be better able to assure the purity of the protein product.
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p>lets not legislate a limit on scientific innovation by assuming that science cannot solve a problem. At the same time, lets keep the bar high as both bills do, to only allow interchangability of products that the FDA is satisfied are in fact interchangeable.
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p>What is wrong with the House bill is that even if one satisfies the FDA, and does a clinical trial, one still cannot have the same generic name, which essentially makes this a non-starter for encouraging innovative investment and affordable products for consumers.
If equivalence is established scientifically, then, sure, have the generic name.
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p>In practice, I’m skeptical, but will be pleased to be shown to be wrong. I think immunogenicity is going to continue to be a highly contingent phenomenon — not to be cracked even by the latest mass spec technology.
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p>Unfortunately, I also don’t have great confidence in the FDA to be the final arbiter of equivalence between drugs, given the lousy job they currently perform with small molecule drugs that require careful titration. (As a patient on full thyroid hormone replacement, I find nothing wrong with generic T4 replacement; but once I find the proper dose, it’s a real pain in the ass to deal with being misdosed in one direction or the other when the generic tablet from one manufacturer is replaced with that from another. Because they aren’t truly bioequivalent within physiologically relevant error margins, these products from different manufacturers are distinct products and should not be considered interchangeable.)