As part of the nationwide “Treat, Not Trick” effort yesterday, AMSA medical students Connie Chen and Rebecca Mitchell organized a visit to Anna Eshoo’s office in Palo Alto. Eshoo’s biologics legislation is a huge gift to PhRMA that will keep important new cancer drugs from ever becoming affordable generics. Their passionate advocacy on behalf of their patients is really inspirational. Watch the video — it will make even he hardest cynic smile.
Eshoo’s staff doesn’t want them to film in the office, and responds by handing them a Xerox copy of Eshoo’s talking points.
Eshoo wigged out yesterday in the Hill and the Huffington Post and launches a bitter, personal attack in response to my article on her PhRMA-friendly legislation — and Nancy Pelosi’s daugher helps her promote it. Which is surprising — I said I was “disappointed” in Pelosi because I thought she was just bowing to the will of the caucus, but I guess she’s endorsing Eshoo’s efforts. (I know Christine, she’s very cognizant of how this stuff reads and doesn’t do things like this in a vacuum).
I’ll have a more detailed rebuttal later, but in the mean time, I invite you to read the Pelosi-endorsed Eshoo melt-down and watch the video of these wonderful young students and compare.
As medical student Sha Ali says, the government is already paying money for the research and development of these biologics, so to make the health care system absorb enormous costs for drugs the public already has an interest in is deeply corrupt — and the cost in human life is completely immoral.
Eshoo’s demand for “data exclusivity” (patent monopoly) to protect “innovation” (blockbuster pharmaceutical profits) is wound around such a shameless pack of lies it’s amazing that it only cost drug companies $712,983 in campaign contributions. As the students say, this is a $71 billion boondoggle for PhRMA. They are paying Eshoo pennies on the dollar for the privilege of raking in enormous profits on government-sponsored research.
POP is joining with these wonderful students to help them fight Eshoo and Kay Hagan, women who are willing to impose a huge financial burden on the health care system and cut off access to the newest drugs that could save the lives of breast cancer survivors. These young people shouldn’t have their hands tied by such corrupt, protectionist legislation that puts corporate profits over access to health care for their patients.
Special thanks to our good friend Jim Ehrlich, the Hippy Gourmet, who went to Eshoo’s office with the students and produced the wonderful video.
You can also Join the Public Option Please Facebook page and follow what is sure to be an entertaining battle with Anna Eshoo and Kay Hagan on Twitter.
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The author of the Kos diary keeps saying they are open-minded concerning the differences of opinion between Jane and Eshoo but seems to update with only biochem industry viewoints in the body of their post. Seems strange to do that if they are trying to listen to both sides.
Wow — handing out xeroxed talking points.
How responsive.
Anna Eshoo lost all credibility when she threw herself on Teddy Kennedy’s coffin while attacking Jane’s analysis of her amendment. She needs a better argument than, “Senator Kennedy was for this!”
Why doesn’t the federal government retain an interest in these drugs, when so much of the initial research is done at taxpayer expense? That seems like a giveaway, not a down-payment or investment on future success.
Does our investment in these drugs ever see a return for the taxpayer? Or does only Phrma profit, even when patients are on public assistance?
Yeah, kind of funny how that happened. PhRMA Concern Troll TM on the recommended list.
Well, glad the paid trolls are doing so consistently well over there. I’m pretty sure our readers are a bit smarter than that and would spot it instantly, as would those at the “right wing” HuffPo.
Hope PhRMA has fun with all their “recommends” over at Kos. We watch carefully for that kind of stuff here and if we think there’s professional propaganda polluting our comments, we look into it instantly (it ain’t that hard to tell if you know what to look for). It quickly threatens the integrity of any blog that lets it go unchecked and so it’s something we’re very vigilant about.
In the mean time, I’m not wasting time on a Friday night diary that plays out on Saturday morning. I’m taking a personal attack from a sitting Congresswoman DOWNTOWN!
Ka-CHING!!!
I still cant’ stop smiling. I can’t believe she took the bait like that.
Anna has used Teddy’s authorship of the analogous provisions in the HELP committee bill before – it’s how she responded to me at her local town hall on September 3. For what it’s worth there is a window box display at the office in Palo Alto with Ted Kennedy’s picture and some flowers (it may be visible to the right of the door in the video). Anna definitely is leaning on Teddy’s memory… and Teddy may have been making te same deal Anna made in regards to giving biologicals some regulatory advantages.
I’m trying to understand this issue a bit further.
What I understand is data exclusivity is when FDA clinical data had to be available for other private use.
How this relates to generic drug availability is convoluted. Generics have to pay patent royalties for 20 years. In practice it appears that much of the patent period occurs years before a drug is approved by the FDA. So the data proving safety and efficacy (and hence FDA license to manufacture and distribute) may be valuable for longer than the initial patent.
Nice try Anna, but no cigar. Either way you dice it, your amendment is a big giveaway to Big Pharma, Teddy Kennedy or no Teddy Kennedy. He’s gone and can’t dispute what you are saying, any hoo. I READ the amendment and it’s pure horseshit! It’s also obscene and immoral. Shame on you, Nancy Pelosi and anyone else that helped to include this evil in the bill. And that includes Kennedy, wherever he may be.
l
Everything she can do to help “breast cancer victims.”
Most women I know who fight breast cancer do so with every fiber of their existence and are some of the most powerful women I’ve known, hardly victims.
Of course a Democrat is going to be interested if the “designated constituency” of middle class and above white women are involved, and that really distracts from the totality of how fucked up the rigged game is for big pharma, where Americans pay a drug tax to support reasearch that leads to astronomical profits and a subsidy so that the rest of the world gets cheap meds.
Solve that problem, and issues surrounding breast cancer come free, solve only the breast cancer problem and so such guarantees on fixing the big picture as these people buy off just enough to quiet the outrage.
Go Jane!
I am so tired of these democrats who feel like they can blow smoke and get away with selling out their constituents to the highest bidder.
I can remember when Anna was a progressive and I was very pleased when she was elected to Congress. I wonder what happened. She is in a very safe district and has plenty of money.
Jane, could you spare some simple answers to the most common dkosian regurgitations?
I know, the last is not even germane to the Eshoo amendment… but it’s getting a lot of replay now among the Great Orange Pearl-Clutchers.
I read eshoos “piece” on huffpo. even most of the rank and file huffpo readers were able to see through it. so jane is “Ms.Hamshire” now..nice (jane i thought you were married?)i also like how she continues to insist she will be “working with sen. kennedy”…through a medium??? you know when you’ve hit a sensitive area when they react as defensively as eshoo did. im seeing that from a lot of “liberals” in congress these days. they all make the same defensive argument to the effect of..how dare you criticize me when ive done this this this and this, AND im close personal freinds with ted kennedy so you cant criticize me!..or something like that. what a sickenly corrupt government we have.
reply to Twain @ 9
A large part of the reason she has lots of money is (as Jane and the students in the video note) $712,983 from Pharmaceuticals/Health Products.
She also has huge support in Silicon Valley.
Thanks Jane. Unbelievable, $1000 for a prescription vs. Mexico at $75. Talk about an exponential markup. The good news, America, is we have more and more healing and miracle drugs. The bad news, you can’t begin to afford them.
I can’t find it among my old diaries, but I remember writing about how much taxpayer money goes into researchng new drugs at universities, but then at the LAST stage pharmaceutical industry sweeps in and does the production/distribution work and cashes in on the exorbitant patent perks and restrictions.
The video is great, and good for them. TRUTH TO POWER.
Also, in case you catch this, great metaphor about beauty contest and tops off and on on Rachel Maddow Show this week. What a hoot. And so made your point.
Scroll down her page at OpenSecrets and you can see that she has received a total of $1,456,476 from the Health Sector and $1,054,524 from Finance, Insurance & Real Estate (no breakdown of their respective contributions).
Pelosi is a waste of space and her public speaking ability is terrible. How did she win office, let alone become speaker? I don’t get it.
The pearl clutchers don’t seem to understand that Eshoo’s amendment replaced Waxman’s which was originally part of the health care bill. That already had a pathway for generics, but it was much better for patients. And since they swallow their information in one load from Eshoo with a chaser from professional PhRMA operatives who don’t bring it up, they don’t even realize that Obama himself was opposed to it.
So whatever they say about me? Well, double down for the President:
I guess Obama “doesn’t understand the bill,” either.
Nitwits led around by a ring in their nose by PhRMA. A thousand comments and nobody steps in to break it up. Nice. Never happen here.
WOW ! Nice piece of change there.
There’s been some bashing of FDL and Jane over there, and I don’t get the reasoning behind it.
more news from the biotech world:
The main question Anna raised was about evergreening. Anna asserts that her legislation prohibits evergreen exclusivity. Jane says the opposite. Anna’s Senior Field Representative promised me Title and section for the prohibition from the bill. I’ll post that when I get it.
It’s also important to get a better understanding of “data exclusivity” and patent protection. They are not the same thing. Patent protection is 20 years, not 12 granted for data exclusivity (or the 7 years Waxman wanted). In practice manufacture is licensed based on FDA approved trials that demonstrate safety and efficacy. The clinical trial data is intellectual property, and that data is required to allow other manufacturing to commence. Conceivably another manufacturer could duplicate the clinical trials, but the cost would again be passed to consumers.
I think Eshoo claims that the exclusivity clock begins when the first clinical trials begin, but I’m not certain about this. Should that be correct, if it takes 7 years to gain approval from the start of trials, then in practice wouldn’t exclusivity be 5 years? That bit of regulation created IP allows for return on the money spent to conduct the trials. Perhaps the return is too high, and medicines that cost $100,000 a year seem very hard to justify…
If I were Anna I would not want to start a war with Jane. There could be only one outcome.
It seems to me that Big Pharma prices their stuff so it will make a profit and pay off all the research (including the taxpayer-funded work), all the manufacturing costs (including the future stuff), and all of their advertising budget for it (including the future stuff), before it goes off-patent. They claim it’s because it costs so much to develop and takes so long to patent, but that ought to be stuff they can figure in advance, even only roughly.
(These days, even the generics are getting pricey.)
Jane,
This appears to be a complicated issue. To counter the indignant DKos “compromise” faction, we are going to need plenty of information with lots of specificity.
As a huge fan of yours, I am hoping you will respond with as much detail as is necessary to clear up all the confusion. If possible, probably the best approach would be a historical rundown to show where Rep. Ashoo’s positions came from and where they fit in with the current political situation. For rebuttal purposes we also need to know, again in detail, what the pharmaceutical industry is trying to do on this subject.
This is actually an opportunity for us all to demonstrate that you are not somehow on the fringe throwing brickbats, as one of those DKos diaries seems to suggest — an implication which makes my blood boil.
Here you go:
Unless, of course, PhRMA propaganda is more to your liking.
Oh am I gonna have fun with this one.
Possibly ot, but wtf!? AP reporting public plan will cover only 2%, a less healthy pool of enrolees, making premiums higher than private plans.http://news.yahoo.com/s/ap/20091031/ap_on_bi_ge/us_health_care_public_p
I wouldn’t get upset about what the PhRMA sheep say. None of them appear to be able to Google anyway.
Especially when they’re available for a fraction of that price in other countries which are not politically supine to pharma.
I respect Jane a great deal. Anna not so much. Anna is a politician, Jane is a gadfly and activist and I identify more with Jane, it’s easy for me to distrust a politician.
Jane making an error about evergreen data exclusivity is possible. If that’s the case I’m sure the error will be addressed, and we’ll go on to the other problems with the Eshoo-Barton amendment.
Btw, the drug industry and research based on government grants is so intertwined nowadays, that you don’t know who’s talking in peer-reviewed journals. It’s positively incestuous with predictable consequences. Two things occur right off the bat: 1) big pharma has exclusive access to results and can use that to their advantage; 2) big pharma is better able to steer research in their direction and away from all other possible avenues to innovation. The upshot of this cozy relationship is fewer options for more dollars (or euros or rubles, as the case may be in this country down the road).
They are not sheep, they are wolves, and are more effective than we are right now as pharma has received everything it has wanted and made concessions that are on the order of magnitude of the rounding error.
A good post describing Pharma costs and profit margins, and their source within federal medical regulatory law would be very useful.
Any business pays for failed products out of profit from successful products or the business itself fails.
Medicine as a product has some unique characteristics – a medicine that can save your life can be sold at virtually unlimited price absent competitive suppliers.
Perhaps this isn’t the place to do this, since I haven’t read all the comments, but I would like to address the issue of biologics, and the pacesetter for our current state. In the early 1980’s Lilly (via Genentech and UCSF thievery/skullduggery) obtained the rights to the first commercial rDNA product–insulin. Because there were no guidelines about approving or regulating this first-of-its-kind product, rDNA synthetic insulin was approved and continues to be regulated not by FDA’s biologic division, but is considered as any other small-molecule drug. Lilly was given patent protection . . . and then when the market was not crying for their new product, they literally removed the competition (their very own natural insulins). Today, diabetics who cannot survive on rDNA insulin–or who have a better quality of life using natural animal insulins–but import insulin from elsewhere in the world. Why? Profit. When Novo followed Lilly’s lead, also removing ALL natural animal insulins from the U.S. market, needful diabetics were cast adrift . . . considered collateral damage in the pursuit of corporate profitability. Despite pleadings to legislators and regulators over 3 administrations now, nothing has been done to allow importation of natural insulins; and diabetics are for the most part captive to each new “latest and greatest” insulin-like analog that comes out of these insulin manufacturer’s labs. Isn’t it strange that rDNA was promoted because it would “reduce costs”. When natural insulins were withdrawn from the market, the cost of a vial ranged from $20-$30 dollars. The last time I checked with a diabetic friend who is always willing to go along with the “latest-greatest” hype promoted by insulin manufacturer and his doctor, a vial was over $130!!
That’s very interesting. You should totally post about that on the Seminal.
My opinion is that it should be against the law to charge higher than manufacture plus 5% for medicines which are created to heal human beings and to protect us all from preventable illnesses. That we permit ourselves to appear to be blind to the commodification of healing and curing illnesses means that we have as a group become cold-heartedly subhuman. To go broke to keep from dying is a personal decision that life is sacred, but to allow others to go broke or to die because of money demanded by PHARMA and others is a societal decision that indicates a morally bankrupt and dying society.
good question
Yep, part of the reason that the advocacy is being done by the Med students and Dr. So is that universities and medical professionals don’t want to jeopardize all the money they get from the pharmaceutial companies.
I asked “who are the validators who will speak out?” And the answer was — basically, nobody. Even though everyone knows how dangerous this is — if this kind of evergreening goes through, it will soon spread to all drugs.
I watched how it happened with performance rights on internet radio and then leaped over into traditional radio. It’s the first shot in a well-rehearsed IP war.
Public interest drugs….what a great phrase. Can’t help think about the bail outs for all the banks/financial now public interest giants. Yes, I know: we are in a crazy world.
Oh, by the way, the diarist says she’s not being paid by Big Pharma.
Which is what a lot of people want to change the subject to, rather than, y’know, address the facts.
Book Salon up at the Mothership with T.R. Reid’s The Healing of America hosted by Merrill Goozner
How wonderful that they all suddenly agree with the sympathetic medical students! First rule of PR — stay on the right side of kids & pets.
The fact that I’m saying the same thing they are seems to just slide right by everyone’s (PhRMA TM) notice.
Disclaimer: I am not a Lawyer.
So looking at HR 1548 (Stand alone “pathway to biosimilars” that became Eshoo-Barton amendment to the Tri-Committee bill) on thomas.gov it does seem to prohibit evergreen exclusivity. The clinical data developed for the “reference product”
Once the exclusivity period for the reference product is ended the clinical data in Sec 101 (k) (III) should be available from the reference product’s trial data.
Or am I reading this language incorrectly?
Then further on:
When I read this I see the objectionable 12 years clock starts at the date of initial licensing by the FDA. Sec 101 (7) (C) seems to prohibit evergreening for changing dose/route of administration, etc. (D) could be stretched, but wouldn’t manufacture of a biosimilar be permitted using the reference product clinical data for the conditions indicated on the initial license ? Wouldn’t this allow off label prescription of the biosimilar for new conditions?
Interesting. It’s a very non-public-spirited atmosphere we live in, to be sure.
I lifted this quote from The Nation (2002):
Perhaps I could send you a copy of the brief which I sent to the FDA’s Office of Criminal Investigation in July. Interestingly, neither they (nor the FTC) acknowledged receipt of the document . . . and when we followed up two weeks ago with the FDA’s Ombudsman, we discovered that the Ombudsman’s position is obviously to explain to the “dumb public” how the FDA works . . . not to intercede or advocate for individuals. Some government regulator we’ve got there, isn’t it?
By the way, in the video I’m the bearded fellow holding the sign with the costs of the three medicines. I had time to take part in the action yesterday, had some questions raised that involve policies I do not understand well.
The interaction between patents and FDA clinical data was news to me this morning when I started researching, and it seems very obscure how the high profits come about. There seem to be parallels between this and other places where IP protection runs afoul of the common good.
Explain why generics cost nearly as much as name-brand drugs, for the same thing (possibly coming out of the same factory).
That’s for stuff that isn’t being promoted on TV and isn’t being tweaked and doesn’t need protection.
I think Marsha Angell would be a strong advocate in this cause led by the medical students. In her book on big pharma she cited a law passed on Clinton’s watch that open the floodgates. Is there nothing this clown did right?
Angell on health care system:
Angell on big pharma:
Source.
I think the text of the bill as it is available at thomas is more to my liking.
Legal writing can be pretty obscure, and this is a complicated issue. So my reading of the bill may not be the same interpretation as a court’s.
When I read the bill I see language that disallows evergreen data exclusivity. It’s possible that you’re in error here and Anna is correct. And this argument about evergreening is something of a red herring.
The 12 year exclusion is bad policy. The overarching question about Pharma IP and excess profit on the backs of sick people says 12 year exclusivity will kill or bankrupt people.
“If they ask what time it is, tell them how a watch works.”
How wonderful that you showed up at the demonstration and carried a sign.
Is this a personal issue for you?
I’m researching this stuff real time, don’t expect me to have answers to everything concerning cost of pharmaceuticals. When I woke up this morning I knew there data exclusivity and patent protection were probably different. I’ve got a better understand of the difference, but very little idea how the two concepts play out in pricing and profits.
I was struck by Anna seemingly going out on a limb and saying Jane’s being dishonest about Eshoo-Barton, saying the evergreen accusation is flat out false. On reading the legislation I’m inclined to say Anna’s not lying about the legislation she wrote, and that Jane is right to be attacking on 12 year exclusivity.
yes, I have two close friends with breast cancer, both are uninsured.
I’m uninsured myself. And I have osteo arthritis that I’m hoping will be treated with regenerative medicine, not surgery. Timing on treatment would put me in a phase II or III clinical trial group.
I do more than carry signs, I make phone calls, inform myself. Thomas is definitive when it comes to legislation. NGO’s have axes to grind the same as corporations, congresswomen and bloggers.
I could be wrong in my interpretation of the language. When I read it I conclude that evergreen exclusivity is prohibited.
section 101 (7) (D) could be stretched to look like evergreen – but it doesn’t look to me like it would prohibit licensing for the same indication as the initial indication used for the reference product, and off label prescription of the biosimilar to treat the new indication is not prohibited – ie the generic could be used for the new disease.
There’s a bit of snark from you in this response. I suppose you’re reading concern trolling from my tone. That’s not my intent, I’m seeing pssible train wrecks, Eshoo could be right on a small issue and playing your ego to distract from the larger problem with the amendment.
You got that right. You got a lot of face/beard time in the video thanks to So’s extemporaneous description of the drugs listed on your card. Good job!
I’m surprised that your day of research hasn’t turned this up then, which is the first thing you get when you google “biologics” and “evergreening”:
Your concern for train wrecks is touching, however.
I have osteo arthritis too. What are you taking for it?
Oh I would like to point out one thing to Eshoo’s defenders:
David fucking VITTER is better on this than Anna Eshoo is.
I know all of you will wear that with pride. As you should.
I really don’t give a shit about getting filmed.
I was there because of a post here on thursday, other activities that had me near Palo Alto at the right time. 6 med students, 4 other people showed up. It was a decent small action at a tactically good location, and having constituents there could make some small difference to the Congresswoman’s staff.
I left with information that contradicted some of what raised my ire. So I looked into it. And I’ve got a whole lot more questions (and unfortunately some loss of credibility from Jane, reading the legislation leads me to conclude Anna is truthful about prohibiting evergreen exclusivity).
Here’s the stand alone bill. I read this and see that the types of modifications Jane says would maintain a monopoly aren’t allowed to keep generic manufacturers from using the clinical approval data to be licensed to make the generic. Which means an error in Jane’s writing, but very little in the big picture… defending that (possible) error is a distraction that distracts from the bigger issues of eliminating obscenely priced medicines.
Eshoo effectively conceded that evergreen is wrong… and we’re wasting energy because Jane doesn’t want to acknowledge she may have made an error. Why?
I admire Jane getting the word out about the event and lots of other good work done by her at FDL and elsewhere. Let’s get on with work to change the bad policy – 12 years of exclusivity.
Connie is genuinely knowledgeable about the drugs on the sign and did a great job speaking about them. All of the med students were earnest and likely better informed than most of us here. It was good to take action with them.
Wow! Nice try! I almost missed that one. It is really hard to believe that you honestly overlooked the EXACT LANGUAGE IN THE BILL ITSELF in favor of a “Thomas” version of an old draft of Eshoo-Barton, which is significantly different.
Here’s the bill itself, release on October 29, 2009 at 10:05 am:
http://docs.house.gov/rules/health/111_ahcaa.pdf
Now, before I recommend to the mods that you and your IP address get bounced out of here for being a PhRMA troll deliberately spreading misinformation, would you like to address this?
I’ll admit to not having the clearest understanding of the amendment, and I’m honesty not sure who’s right in this argument. But given that, is there any reason to think the Kos diarist is a paid Pharma representative? Do we have evidence of that? Is it at all possible that it might just be someone with a different reading of the bill?
You have seriously, seriously pissed me off. Don’t you ever, ever come in our comment section and spread pharmaceutical industry misinformation. You have exactly one more comment to make here explaining yourself and if it isn’t damn good, you can go spread their propaganda some place else.
my first words to oldnslow when I saw the HuffPo piece
“Honey come look, Eshoo bit on Hamsher’s gaffing hook, ya gotta come see this !”
For reference, start at 1537.
I take ibuprofen and cannabis. Ibuprofen is somewhat problematic because of kidney function issues – I also take an ACE inhibitor and my blood potassium level is higher when I take ibuprofen. unfortunately neither medication is very effective, I limp and am in considerable pain. At the time of my diagnosis I was told I would need a hip replacement about 8 years later. I’ve done some physical therapy, it helps and I do exercise to try to keep flexibility and strong supporting muscles.
I find http://thomas.loc.gov to be definitive when it comes to content of legislation. The position paper you cite mentions
Here’s the language from thomas.loc.gov:
“Does not include the date of approval”, I read this as the clock starts with first license and these minor tweaks do not restart the clock.
Eshoo said evergreening is prohibited directly. If my reading of this is incorrect then she should be amenable to fixing it.
Fixing the 12 year exclusivity is worth focusing on.
S.726 looks a lot better than Eshoo’s bill as well. The language on evergreen prohibition is less ambiguous, and the exclusivity period is only 5 years. Schumer is listed as the author, surprisingly Susan Collins, Blanche Lincoln are also cosponsors (along with Vitter).
Thanks for pointing S.726 out, it gives credence to Eshoo’s continued name dropping – a better alternative could have reported out of HELP.
Page 1537 starting on line 23, through line 1538, line 17. “shall not apply” ie the clock doesn’t restart.
Sorry to piss you off.
The role of Pelosi’s daughter is no surprise. Everyone knows that her son Paul has two full-time jobs, right? One with Angelo Mozilo’s bankrupt Countrywide Mortgage (and yes, he has a below-rate mortgage there too), and the other with Clinton-backer (and frequent shareholder lawsuit target) Vinod Gupta’s InfoUSA – a leading mass-mailer and polling conglomerate. A self-made man, without doubt…
Business as usual in Washington!
Howie has a piece from Sept. I’m using in a diary-in-the-works
in it, a critter talks about how progressives all show up truly progressive dot dot dot and the beltway and incumbency rackets get to ‘em, citing Donna Edwards as a still unspoiled example
which is a long winded way of saying I too remember Eshoo when she was first elected. we were constituents. and all that public good work she cites in her HuffPo piece were things she did her first term in office.
we lived in Palo Alto for 25 years and I’m telling ya firedogs, the good people of her district would be appalled at some of her um, work. they simply wouldn’t believe ya at first
but something tells me that’s about to change
Just more of my two cents. Generics are not so great anymore. Why? Because they are being manufactured overseas, particularly in India and China. Would you like some melamine to go with that diuretic ? Increasingly, more of my patients are experiencing side effects and lack of efficacy with generics. They are not the panacea to our drug problems. Also, many, many drug trials are conducted overseas, not here in the States. Drug companies use the data to market the products here WITHOUT spending all that dough on so-called RD as they claim. Drug companies–want to save some money? Stop direct marketing to the consumer. That should save you a few billion. The only other country that allows this obscene practice is New Zealand, a place where there are more sheep than people.
There is nothing in Eshoo’s bill that directly and unambiguously bans “evergreening.” Please, someone point it out and I will be happy to admit my mistake. Pelosi has yet to explain her reasons for canning the Waxman Bill. This whole thing reeks to high heaven!
I noted 4 of the groups cited in that Big Orange Diary are astroturfy
Actually, PhRMA is much more concerned with evergreening, because if they can start the IP precedent here, they can migrate it to other drugs.
The position paper was written prior to the release of the final bill. Eshoo’s language most certainly addresses the final bill. Which someone with your degree of technical sophistication should be able to discern.
That’s three strikes, pal. You had your chance to go in, look at the relevant language, and adjust your commentary. For someone who went to the demonstration with the medical students, has been “researching all day” and who also sent me an audio tape two months ago of an Eshoo town hall comment where she says she supports a public option, that certainly wasn’t too much to ask.
Instead you deliberately avoided reprinting the relevant language in the final bill. If you’re just a huge Eshoo supporter obfuscating on her behalf I don’t really care, but the district is full of biotechs and the level of sophistication you bring to the misinformation sets the warning bells to ringing.
Let’s see. Glaxo earned an extra $2.3 BILLION dollars by extending its market monopoly on Flonase for two years through a variety of manipulations of the FDA. And then they dominated the generics market by selling generic FLonase through a generic front company.
You think they weren’t above spreading a few million on some friendly Congressjerks? And GUESS what their biggest new strategy is: buying biologics.
WMD, unless you are a lawyer or a lobbyist, you have no idea what you are reading. The exceptions are listed twenty pages away… but as a PhRMA rep, you already knew that, right?
Eshoo’s language on exclusivity is much more open to interpretation than s.726. Schumer wrote a better bill – do we have an hope of getting Schumer’s language into what comes to the floor of the Senate?
Keep exclusivity at 5 years in the Senate bill, possibly compromise to 7 years in conference?
As for “deliberately avoided quoting from a 1900 page pdf” well here you go:
I don’t particularly support Eshoo, I did find it worth evaluating both sides on my own. Call me a PhRMA rep or whatever, I’m not. I’m a currently unemployed software engineer that keeps chickens.
I’ll have to look for the exceptions Auduboner claims exist 20 pages away.
I really liked this comment – very straight forward refutation of her “facts”
I have several friends who work/worked for a big PR firm and during the net neutrality battle a couple of years ago, they report that the firm was paid $10,000 a month by a telecom company to do nothing but have operatives go spread shit about Matt Stoller in the comment sections of various blogs. They say that it was part of a much larger effort and that many firms were making big money just to discredit him. It’s chump change for them.
There is absolutely no doubt that the quality of the comments over health care have a similar character, and with 17% of GDP at stake, I’m sure the money is flowing liberally. Which doesn’t mean everyone is a paid troll — many just feel a certain way, and that’s fine — but after 5 years moderating this stuff you get a feel for it. They usually are all operating off a particular play book.
Here’s a HuffPo comment, for example:
Sound familiar?
Gotta be careful with the breast cancer thing or it can backlash on you, so patient “concern troll” is the modus operandi.
I think it would not be possible for the government to patent its innovations in any field even though it largely subsidizes innovation in virtually every technology that private firms use and benefit from. This
used to be the way innovations in science were shared, openly and at no cost.
I think that patent laws should extend only to demonstrably new methods or products, and only to the extent of the actual cost independently icurred in their development. So let’s say a new drug is derived using methods already in place and your new contribution has cost you an additional 10% to develop. Then on the price of producing the drug you add 10%. Then after you recoup your investment you are given say 5 years of patent prices before your patent expires.
So if a drug costs $50 dollars to make you sell at 10% above the profit price whatever that comes to. The point is that the price even with patent rights should always reflect the actual costs incurred in its production.
Anna is a friend of the family. This is not going to go over very well.
My interest in this:
I want medical costs to decrease. Generic drugs have some potential to do this.
I think honest debate is better than misleading debate, and both sides can mislead.
I started today not knowing that we were talking about use of clinical trial data for licensing of manufacture of drugs as opposed to patent exclusivity. Which is still 20 years, but in practice is much less due to filing time frames – patent filing occurs years before FDA licensing, so in practice the date of FDA approval matters more than the date of the patent. I learned something here.
I have an analytical and skeptical mind and I don’t naturally defer to authority. Sometimes this offends people and leads to them making defensive responses. I’ve seen this happen in other areas where I’m politically active – people using misleading information get pissed off when alternative viewpoints are offered.
Jane posting info about S.726 showed me a much better alternative.
The language on evergreening there is light years ahead of Eshoo’s. That doesn’t mean Eshoo was lying when she called Jane out. Eshoo is a politician and knows that she can’t get away with unsupportable accusations in this day and age, and also had to recognize that by making this particular accusation she cedes the issue of evergreening prohibition. Eshoo says it’s prohibited, she damn well better deliver on it, which means we should be able to get language less subject to interpretation in the final bill.
Does any one else get a whiff of McCarthy in accusations that I’m paid by PhRMA?
In truth I’m about 3 months from not having money to pay my bills. I should be bailing on my mortgage, house is underwater as far as debt. Earlier Friday I had a good interview for a start up high performance computing company, so there’s some hope… plus a position I was 2nd choice for back in July has reopened – I think there’s a shot that I could take it on as a 1099 worker as opposed to GS. Reason I was 2nd choice was I made it clear that I’d look at position as a bridge job – I said I saw myself doing technical application performance optimization work elsewhere 5 years later, not doing system administration work for academic supercomputing. On a 1099 basis that shouldn’t matter… probably higher pay, no benefits which could make me eligible for a public option health insurance plan eventually.
My liege, my liege, keep swinging and hitting the bastards. Hit extra hard the ones with a D behind their names. They are the worst. And, don’t get me started on Independent Joe – from CT…
If you want to see what excessively long intellectual property terms do to innovation, check out Hollywood.
Time to ditch the evil term ‘intellectual property’ and be clear about what we’re talking about — limited monopolies granted by the government.
I would like to ask everyone to excuse me for interrupting this discussion, but there are a couple of points in this particular comment that A) seem unrelated to the legislation, and B) I can’t resist calling out. I’ll try to be brief.
First, your handle is wmd1961?
W = Weapon of
M = Mass
D = Destruction
1961 = Barack Obama (year of his birth)
You wouldn’t happen to know a sleazy ‘Birther’ named Ed Hale, would you?
As to your comment:
The “both sides can mislead” assertion is a simplistic and nonsensical fallacy. It’s nothing more than the kind of bs that comes straight out of the playbook of someone like Karl Rove. For example, it’s one of the pillars of the so-called journalists at Faux ‘news’ and, while it works just fine for them as they manipulate their viewers, it’s not going to get you far here.
No. I don’t get any whiff of McCarthy in pointing out the fact that there are people who pretend to be concerned citizens or legitimate journalists as they use various media – blogs, 24-hour cable television channels, whatever – to spread false information, confuse discourse, and so manipulate public opinion.
Again, I apologize to all for interrupting an otherwise excellent discussion about, as Jane put it in her post,
wmd1961 has been a commenter at FDL for many years and had that name before BO was a candidate.
Your never ending search for trolls misleads you once again.
Best keep it in your holster. wmd1961 is an esteemed member of this community.
Good try!
This is all getting a little embarrassing.
I’m not here to search for trolls, though reading the comments on this thread certainly makes this wmd1961 seem like one, even to someone who’s been around the Lake as long as anyone (take a look at comments @57, @59, and especially @68 above, for example).
Thanks! I have some experience with Birthers, as many pretended to be Hillary Clinton supporters last year. I know how they think, and wmd1961 is exactly the kind of garbage that a Birther would come up with.
Anyway, I apologized in the comment above for interrupting the substantive discussion in this thread. Now I’m even more sorry. Please stop pointing out that I was wrong – whether I was wrong or not – and return to the subtance of this discussion.
wmd are the initial letters of my first, middle and last name. I used bmd for a lot of my first years on computers back in the punch card days until the university caught me due to another user with the same initials wondering what the hell this card deck was in their output bin.
1961 is indeed my birth year.
My introduction to Ed Hale came from your link. That insinuation makes me think Pot, Kettle, Black when it comes to Knoxville’s attack on something tautological – both sides can and do mislead.
I don’t like Eshoo’s data exclusivity stance. I don’t like evergreening. And I think we should be willing to examine the legislative language and not automatically give credence to a blogger or a Congresswoman. I’m a bit saddened that Eshoo engaged with Jane by saying Jane is wrong, because that moves discussion into personal attack territory regardless of who is correct. I spent my day today looking at the controversy without prejudice, at the end of the day I still say Eshoo’s statement that she prohibits evergreening is defensible. That doesn’t make me a paid schill and it’s an ad hominem to claim otherwise.
Anna said something worth engaging on – she opposes evergreening to the point that she wants her legislation to prohibit it. If better language exists (and Schumer’s language on evergreening is a lot plainer than Eshoo’s) then she should be willing to replace it. I commented to the two fine UCSF med students that getting a staff email address is a good outcome from yesterday’s action, the contact form at eshoo.house.gov is excreble, and boilerplate responses to specific questions are the rule there which is very frustrating. I look forward to continuing communication with the Senior Field Representative I met yesterday.
If there is a way to get Schumer’s language into the final senate bill we should do so. Blanche Lincoln, Susan Collins, David vitter of all people cosponsored Schumer’s biosimilar legislation – the better biosimilars bill has Bluedog and even republican support.
I’ve had 4 congresspeople. Eshoo ranks second to Lee Hamilton in the quality of representation. Francis McCloskey is third (and I could be convinced that he was better than Eshoo on several counts – his courage engaging SoS Christopher over war in the Balkans impressed me), Baron Hill is fourth. Every damn one of them is/was pwned and I don’t like that, but I am able to discriminate based on their willingness to engage in discussion with constituents (as opposed to solely lobbyists) and to change in the face of pressure to better represent the public interest.
I wasn’t trying to attack you by pointing out that wmd1961 could be an attack on President Obama, as it appeared to be to me because of my ignorance about who you are. I do think that the “both sides” nonsense is a logical fallacy and an oversimplification that is often used by those who mislead while accusing the so-called “other side” of misleading. Anyway, I’ll just apologize for a third time for having interrupted this important discussion and thank you for returning to it.
no worries.
I didn’t want to piss Jane off. I’ve tried to keep my irritation under control as well, having a thick skin is important in on line communication.
This forum deserves civility and I try to keep it that way when I comment. Over on my motorcycle club’s forum… not so much. GTAFFIARD is one of the milder rejoinders there.
Look I don’t even care if you spread disinformation or are just plain wrong or open up different lines of thought or whatever. But professional commenters are now a part of any big lobbying/PR budget, and they can be the death of a comment section — or a blog.
If you start to sound like one, just know that it’s probably the thing that makes me most nervous about running a blog right now. We’re going to be taking several steps soon to make that a lot harder to do. If you think Eshoo’s great, by all means, defend her whole-heartedly, that’s wonderful. Just be careful about spreading distorted information that would accrue to the benefit of someone with a big psyops budget, especially right at the time they’d be spending it.
Eshoo is a sold out po and her legislation is a give away to pharma, much as both houses of our Congress and the present public options are. Complete and utter giveaways to move tax payer wealth upwards in exchange for virtually NOTHING of value to the masses.
I eagerly await Mz. Hamsher’s next piece in reply to Eshoo’s mistaken and foolhardy display on display at HuffPo.
Kick pol and troll/likeatroll ass Mz. Hamsher, it’s a pleasure to watch you do so and hold feets to fires.
*G*
fair enough. I’m not a paid commenter. I’m an unemployed professional with strong analytical and research skills. I have no interest in being a hired gun for a political lobby (well I could see doing some PR work for Rob Kampia or Ethan Nadelmann in some roles, but stealth/astroturf isn’t something I could do).
Eshoo’s legislation isn’t good. My take on her attack on you is that is is defensible, and rising to defend yourself wasn’t a wise move.
Accepting her implicit ceding that evergreening is bad policy and helping strengthen her “prohibition on evergreening” makes a lot more sense. I’m going to be engaged with her staff to try and push for clearer anti evergreening language, and I’m thankful for the pointer to Schumer’s biosimilar bill.
I apologize for any offense you took from me.
I apologize for jumping on you. I understand what you’re trying to do, and appreciate your patience with me.
And I totally respect you going out and being there with the Med students. And with the Hippy Gourmet. That rocks.
Eshoo SHOULD hire you — you’re a good online supporter, and she’s gonna need a few.
;)
No worries. And I wouldn’t work for Eshoo as a paid online supporter because I don’t like how she’s been pwned. I’ll work with her staff to help make biosimilar evergreening prohibition stronger and her attack on you paradoxically makes that easier.
]Suzanne hosted a late late night that left me feeling that down home FDL feeling I treasure.
I’m +2 now, so time to sleep. Thanks Jane.
Personally I don’t understand the logic of requiring a completely new set of tests for a generic that is essentially identical to an already tested drug. The tests were submitted in order to obtain licensing. The Federal Law protects patents, not the tests, which are public information submissions. It has nothing to do with the methods, technology or composition of the drug.
So if a generic is chemically and bio-identical there should be no need for a repeat set of testing. It simply increases costs and delays the marketting. The Pharmaceutical industry is using this to simply create an additional extension of pension term.
Given that universities (and students are recruited) are used to do most of these tests there is already State and Federal contribution to these initial tests. And the public itself, when the drug is placed on the market, act as a further – larger – statistical test for any corrections.
Thank you for this, Jane. And thank you, too, wmd1961, for your commendable calm under pressure.
I probably didn’t pay the closest of attention in reading, nor pursue every link, etc., but I did read both Jane’s compelling post and Eshoo’s well-written response, to try to better understand the issue, and I ended up uncertain about the core problems Jane raised, without doing further research of my own.
Whether or not Rep. Eshoo is familiar with Jane’s work, she clearly went out of her way to denigrate Jane’s motives, implying bad faith (or petty politics) on her part, without cause or justification, rather than simply attempting to rebut Jane’s arguments. And Teddy is absolutely right that Eshoo repeatedly shielded her arguments behind Kennedy’s legacy in a contemptible and telling ‘pulling rank’ fashion. Perhaps in a way, though, there is an illustrative parallel in how Eshoo responded to Jane, and how Jane originally responded to wmd1961 here – both Jane and Eshoo are obviously deeply personally invested in this issue (no pun intended) for different reasons.
Like wmd1961, I await Jane’s response to Eshoo’s post (rather than doing my own homework) – which I think his comments here may help improve – in order to better understand Eshoo’s amendment (about which, I think the endorsements of groups fighting for a cure for AIDS and ALS, etc., carry significant weight with me – unless they likewise endorsed Waxman’s version and similar Senate language, indiscriminately).
This is debate – the kind of democratic debate that should be taking place on the House floor, or in committee meetings – where we have argument, counter-argument, rebuttal, until the issue is clear-cut, and uninformed observers can make up their own minds with comfort. It’s telling, indeed, that instead of the custom-designed forum for debate that is our federal legislature – where all the participants are known and identified and given equal opportunity in a defined period of time – we must resort to the internet, and its interrupted interaction of varying visibility, to obtain any kind of democratic debate on the most important issues of the day.
Two drawbacks of an intermittent internet debate in lieu of regular-order Congressional debate, are that on-line participating commenters can indeed be suspected due to their anonymity, and elected officials like Eshoo still feel the need to hurl insults simply because someone – who she doesn’t deign to acknowledge in the normal course of events, because not also an elected elite – dared to challenge her actions in office. Eshoo should take such obviously good-faith criticism in stride – it comes with the territory, as do the perks and the privileges. And she should urge her pal Speaker Pelosi to re-open the House floor to genuine debate and amendment, so that vital, life-altering policies and decisions like those under development in the pending health care legislation are fully aired in public, and debated, amended and made understandable to all who wish to be informed, however complex the issues may be.
Marcy Winograd, Rep. Jane Harman’s opponent in next year’s Democratic Party primary, helpfully weighs in on the subject over at DailyKos:
There’s some people over at Ezra Klein that are really obviously being paid. They comment constantly, know a LOT about the insurance industry (and so are able to mislead about it better), and they answer every little thing 24/7. His policy seems to be to do nothing about it. But they are so obvious!!