Biotech Industry Needs 42 Representatives to Try to Refute Jane Hamsher
On October 29, Jane wrote a scathing post about what Anna Eshoo’s provision to give biosimilars a route to approval would do, focusing on the 12 years–and probably more–of monopoly it would grant.
The following day–October 30–Eshoo responded.
On November 2, Jane ripped apart some of Eshoo’s details. She reminded Eshoo that no lesser legislative whiz than Henry Waxman has made the same argument Jane was making. She pointed out that taxpayers have already paid for many of these drugs.
Meanwhile, a bunch of earnest medical students started pressuring law-makers directly.
And then, the NYT tells us, the biotech industry started recruiting Representatives to publicly state their support for the biologics measure.
Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genentech, one of the world’s largest biotechnology companies.E-mail messages obtained by The New York Times show that the lobbyists drafted one statement for Democrats and another for Republicans.
[snip]
The e-mail messages and their attached documents indicate that the statements were based on information supplied by Genentech employees to one of its lobbyists, Matthew L. Berzok, a lawyer at Ryan, MacKinnon, Vasapoli & Berzok who is identified as the “author” of the documents. The statements were disseminated by lobbyists at a big law firm, Sonnenschein Nath & Rosenthal.
In an e-mail message to fellow lobbyists on Nov. 5, two days before the House vote, Todd M. Weiss, senior managing director of Sonnenschein, said, “We are trying to secure as many House R’s and D’s to offer this/these statements for the record as humanly possible.”
He told the lobbyists to “conduct aggressive outreach to your contacts on the Hill to see if their bosses would offer the attached statements (or an edited version) for the record.”
That big dollar lobbying got 42 Representatives–42!!!–to try to refute the arguments that Jane was making.
Our Jane has them running scared, I guess. I wonder how much those 42 Congressional parrots cost Genentech (which is located in Anna Eshoo’s district)?
While I’m grateful the NYT has called out these 42 Representatives for being industry parrots, there are a number of questions the article raises. Such as, who are the 42 Representatives? The article mentions:
Republicans
- K. Michael Conaway
- Lynn Jenkins
- Blaine Luetkemeyer
- Lee Terry
- Joe Wilson
Democrats
- Robert Brady
- Yvette Clarke
- Phil Hare
- Bill Pascrell Jr.
- Donald Payne
That’s just 10 people; the article stated that “more than a dozen” lawmakers used Genentech’s talking points almost verbatim and reports Genentech bragging of getting 42 Representatives to use its talking points. (Note two people missing from this list: Eshoo and Barton, the measure’s co-sponsors.) So who are the others? And who might the other 30 that Genentech boasted of?
Also, it’d be really nice to show the emails, so Americans can see how little it takes to buy a member of Congress.
Finally, it’d be nice if they showed us either the talking points or the speeches made by the members of Congress to save us the time it’ll now take to dig that out of the Congressional record. I wonder, for example, how much of Anna Eshoo’s response to Jane on October 30 came directly from her Genentech script writers?
And, adding to your post, the health care industry needed to get Stupak (and his friends) to shoehorn in his anti-abortion amendment, so as to knock Jane’s and FDL’s whipping the Dems for a bit of a loop, because the public option was actually getting somewhere.
That’s what I took away from the whole Stupak thing: a big, bright shiny object to divert progressives from continuing their (very effective so far) whipping the public option, most likely by getting the progressives into a real tizzy, thereby allowing TPTB to paint them as “Shrill”.
Interesting as to Pascrell and Payne – they don’t have much reason for voting/positioning themselves that way, other than a Roche plant along Route 3 in Nutley (somewhere along the border of their districts and employing people in both dstricts).
Isn’t Nutley south of there?
Also note that with the Roche/Genentech merger, there have been a bunch of layoffs.
So GEnentech is getting a bunch of Representatives to talk about jobs, even while they’re laying off people in the Representatives’ districts (including almost a thousand in Eshoo’s district, at least).
No.
Nutley is between Clifton and North Newark (or, if you want to expand the scope a little, between Paterson and Newark). The Roche plant is on the south side of Route 3, just west of the Hackensack River. It lies astride the dividing line between Pascrell’s (Paterson) and Payne’s (Newark) districts. In truth, the dividing line runs down local streets and through parks and such there (it’s all built up with first- and second-generation suburbs), such that one would literally have to walk the line block by block to see exactly where the line lies.
But the key thing is that people in both their districts are employed in that plant in some of the last few good-paying sorta-industrial jobs left anywhere in Joisey.
Right–but there are thousands of jobs lost in Nutley since Roche took over Genentech. So Roche/Genentech are actually eliminating jobs.
As best as I can figure, these two critters recognize that, but are playing their own brand of kabuki. The theme of that play goes something like:
To these critters, signing this letter is pretty much like the letter of recommendation they give someone they kinda know: “I’ve met the guy andhe seems all right to me.” A reflexive, formulaic act.
I was going to boo and hiss Luetkemeyer, but as I suspected Columbia is in his district.
But still, it should be a minimum requirement to write your own speeches out of understanding why these things are important.
Furthermore, the U-based research is often heavily federally funded. The Roches come in late in the process and market the drugs. But they’re not paying the bills all the way through–we are.
I’d bet that a lot of the folks in Congress have their staff writing their speeches.
I wish they were honest enough to admit that they’re getting their healthcare information from lobbyists. (Remember it was a lobbyist who wrote Baucus’s crappy bill.)
I am sure you know this, but it was a revolving door: staffer-lobbyist-staffer.
In the 21st century I suppose it is not realistic for Congresscritters to write all their speeches themselves, but the staff member is paid with public money and can take more direction on what the Congresscritter wants to say out of his/her own brain than a lobbyist.
I read Nell’s comments on public disclosure of staff members.
This page shows some of the medical research projects taking place at Mizzou.
First, I’m very pleased that they only got 42 congresscritters out of 435. I’d have figured a much higher number would be motivated by an immediate cash donation and the promise of more down the road.
Second, I’d bet not one of those 42 feels they have been paid enough debate Jane on the issue directly. They’ll stay on the house floor with their “data” where they’ll be nice and safe from that landshark.But I’m sure Rachel would love to have ’em.
@5 – You don’t want that. Congress desperately needs those speechwriters! And most of congress understands the issues quite well: If I vote this way, I get $xxx and yyy relection votes. If I vote that way, I get $xxx and yyy relection votes.
Joke running around Ohio was that Voinovitch had to have staffers order his pizza, as he could put the operator to sleep before he finished his order.
Boxturtle (And he liked plain pepperoni!)
Nonetheless, the Association of American Universities endorsed the Eshoo amendment on July 20 when it was still in committee. You can find the letter by googling “university Missouri biosimilars”.
I’m sure they did, given the amount of research grant money that flows from the bio industry to the Universities.
Boxturtle (Graduate assistants work cheap)
I don’t know the figures on that. My experience is that nothing much new gets discovered unless it is funded on a repeating 3-year schedule, and preferably in 5-year chunks. NIH used to do that, but any corporate project I ever saw was likely to dry up and blow away overnight: new VP didn’t think progress was being made rapidly enough, was the usual reason given.
So, “real research” outlasts grad students and techs usually, corporate interest almost certainly. How much corporate money accomplishes, therefore, in terms of gaining new knowledge is completely unclear to me, as I have never seen it happen.
I found it disturbing the other day that I was not able to find any NIH database open to the public that listed the grants that are currently funded, never mind research abstracts and such. Does anyone know how to get an overview of NIH-funded grant work?
I might also remark that from the budgets I saw and heard about, budgets for NIH funding are dirt cheap, and the amounts thrown around by corporations are, by comparison, immense. I would not be surprized if the cost-per-knowledge-increment of corporate research is 10 times that of NIH-funded research done at universities and hospitals. They don’t call it “big” Pharma for nuttin’…
My experience is that corporate donations fall into two catagories, long-term and short term.
Long term are the rarer of the two, but may go to the extent of endowing a chair. Whatever research is done is in the area of interest of the corporations.
The short term donations tend to be a large amount of money over a short time with a specific goal in mind. Large is relative I suppose, most of these that I was aware of were in the mid five figures. But these are what gets the universities the new lab equiptment, as they budget the long term stuff long term.
Point being, I’m certain that all the Generic Bio Corp’s out there have enough influence with that group to get them to issue a statement.
Boxturtle (For enough money, a university would sanction a report on lunar green cheese for Kraft)
Well, the other thing is universities are reliant upon the big cos to take this stuff to market, so they want to stay in good so they can sell them the research.
And why does world’s pharmacalogical research have to be paid of by the population of the United States of America?
All other countries get their drugs at much lower costs, but we are not allowed to import foreigh drugs nor is Medicare allowed to negotiate nationwide deals with the drug companies. The argument supporting that legislation was that these high prices were required to support research. But, so far as I know, we’re the only ones paying those prices, even though many of the big drug companies are not located here.
Good point. How about some multinational collaboration?
However, see my #24. Pharmacological research (at the phase II and III levels) should NOT be done by corporations that stand to profit immensely from marketing the agent. Rand and Cato are wrong in their assumption that For profit entities don’t lie or fake data because it would be bad for business..And Greenspan admits it. Too many deaths to recount here.
In fact I quoted that and replied with adamant agreement at #30, but apparently I neglected to his the “reply” button, so it doesn’t show up as a reply.
Thanks.
BTF, you can find proposal abstracts online, but usually the only people who see the full proposal are involved in the peer review. The rest of us have to wait for progress reports and scientific presentations.
This ostensibly protects the novel ideas being tested in the funded research from being poached by other academic or corporate interests (not to mention scientists from China, India, and other intellectual property Wild West locales.)
You can also see that the amendment was still in committee when the letter was written.
This is the kind of Bullshit that makes me just want to hurt people !
good morning empty and firedogs,
although I am no longer shocked by any one of them crossing over, I must say I am dismayed at seeing Yvette Clark’s name – she has been such a straight, reality-based shooter
Perhaps overstating the obvious and maybe worth ignoring for the moment to focus on increasing public access to biologics BUT this is surely just the tip of an enormous iceberg. I’d wager reps have been reading lobbyist scripts into the Congressional Record for decades. There are no honest debates on the Hill.
As teh NYT points out, the difference this time is that someone got the emails to demonstrate it was all planned.
It’s possible that there are some, but not enough.
I’m ticked that they won’t admit that they’re using speeches that were written by lobbyists, and then getting them into the CR as if those were genuinely their words and views. (Makes me think of that totally imaginary exchange that those GOoPers had the CR put in, a few years back, just so they could cite it later.)
When I watch congresscritters on C-SPAN I often wonder if there are any other reps present or if they are addressing a mostly empty chamber…
The problem with the Eshoo PhRMA-driven language in H R 3962 was presented very well at Firedoglake the other night by Howard Rodman’s account of his wife’s story in The Algebra of Need: Cancer, Biologics, PhRMA.
During the course of discussion in that thread, I was amazed to learn that Eshoo pulled off her gift to the biotech industry. I wrote:
This is definitely a fight that needs fighting and a fight that needs finishing.
Amen!
Jane’s alertness and work on this has been magnificent.
First stop the Eshoo amendment. One step at a time, continue to address the entire process.
(I would also add the note: Private corporations that stand to profit from marketing pharmaceuticals should NOT bedoing the pharmacological research on said product. Remember the Tobacco Institute? How abut Merck and Vioxx.?) How to make lots of it, that’s different.)
fyi – PHRma’s go-to and oft cited guy was Duke Econ. Prof, Henry Grabowski – until James Love and James Glassman factually destroyed his swill
At long last Obama got his bipartisanship since 22 Republicans and 20 Democrats all sang the same tune.
IMO, I think this an open source project. Need to identify the biotech facilities in the backyards of the 42 reps and exactly how many jobs have been lost over the last several years.
It’s been a strategy of pharma and biotech alike to move more than jobs offshore, been this way for at least 10 years. They are basically asking for the ability to take research, much of it funded with federal dollars through public university research programs, claim it for a U.S. site, then shift the rest of the work in R&D and early commercial production to offshore sites where regulatory barriers are lower to approval and eventual commercialization.
The following day a (possibly corporate) concern troll had a recommended diary at Dkos that made it sound as though Jane had launched into a scathing personal attack against Eshoo. But, in fact, Jane mentioned Eshoo only once in that article:
Eshoo’s response was considerably more personal as were many of the Dkos comments
I wrote a brief analysis of Eshoo’s response in Jane Hamsher vs. Rep. Anna Eshoo (Nov 2, 2009), concluding with:
It’s sad to think that Eshoo might have taken heart from the Dkos comments, seeing how her arguments totally sucked.
Jane has indicated that she thinks that those Dkos diaries were by coporate trolls. I suspected as much, based on the contrived pearl-clutching phraseology, even before Jane said so, but I’ve never felt all that sure of it.
Some of the Dkos comments may very well have been written by corporate trolls. They do have ridiculous amounts of money to spread their bullshit.
I’m sure Jane also knows that she’s in a position where she will have enemies who are predisposed to attack her regardless of the validity of her arguments. She dismisses paid trolls, but she also seems to be willing to treat anyone who sincerely disagrees with her not as an enemy, but as an opponent who should be debated forcefully, but respectfully.
It’s hard not to respect someone like that.
Eshoo continues to use Kennedy. I got 3 boilerplate “we passed health care reform” emails from her this week. Here’s what she said about biosimilars:
I asked her Senior Field Representative Rachel to address the “structural change” evergreen loophole several over the course of the week after “Treats, not Tricks”. Pointed out that 5 years of exclusivity was projected to save $71B over ten years, and that cost was forcing Americans to coose between death or bankruptcy. Was told I’d hear directly from Anna about the issues.
So far just the boilerplate on how proud she is to have voted for this historic bill, nothing on substantive issues. She keeps this up I’m going to ave to reconsider if she’s better than Baron Hill, let alone Frank McCloskey in the pantheon of my Congressional representation.
BTW, Genentech isn’t in Eshoo’s district, it’s just North of it in jackie Speier’s district.
Sorry–is it the Roche facility that is in her district?
Re Genentech and Roche being in or near Eshoo’s district:
I wonder if Eshoo has designs to run in a state-wide election some day, say for U S Senator from California.
Wouldn’t her efforts be rewarded then as much as now?
Genentech is a Roche subsidiary, it does have facilities in Eshoo’s district, just has its HQ in Speier’s.
There is a lot of biotech industry in the bay area in general. Drug development is a fraction of it; my nephew’s wife went from a post-doc at Lawrence Berkeley Lab (Berkeley, Ellen Tauscher) to a DNA sequencing company in Santa Clara (Eshoo) and on to another company in San Diego. None of her work has been drug development, almost all of it enables research that could lead to new drugs or treatments.
I’m incensed that Eshoo and Kennedy were persuaded to give 7 years extra exclusivity and presumably $7.1B per year profits. This isn’t legislating in the public interest, it’s pandering to special interests at the expense of sick Americans.
Knoxville@46 – I don’t see Anna running for higher office. Too many viable candidates that are capable of self-financing a campaign – viz Fiorina and Whitman running for Senate/Governor now.
also responding around that time was Newsweek’s Jonathon Alter, who I heard on I think Thom Hartmann’s show, saying that “with all due respect, Jane Hamsher doesn’t know what she is talking about” and that she was wrong about the Eshoo measure.
That the first I’ve heard of Alter getting involved, but I’m not at all surprised. He very good at projecting “sincere concern” both by his tone of voice and the anguish on his face. In fact, he’s a little too good at it.
What the heck did the ‘edit’ box do to my paragraph breaks? They all went away when I saved from editing. (Someone ought to look into this, hint, hint.)
If you refresh, you’ll see that the edited version is just fine. It’s a minor, squirrelly bug in the editing tool that once you edit an already published comment the paragraph breaks seem to go missing.
But they’re still there. Give it a whirl and you’ll see what I mean.
If you refresh the page, you’ll see the paragraph breaks are still fine. It does it to me as well.
Boxturtle (stupid computer)
Exactly! “He who pays the piper calls the tune” IMHO, safety and efficacy research should be publicly funded following corporate-funded pilot studies.
How many plastic chachkes with company logos does it take to buy one Anna Eshoo? Either she and her BFF representing BigPhrma want to allow an industry to fleece and/or financially ruin desperately ill patients and their families, and drive up the cost of health care, *or* she can’t admit she made a big mistake, *or* . . . *the brain explodes* It’s repulsive. completely and utterly repulsive and morally turpitudinal.
Find me more than 42 congress critters who know the difference between DNA and RNA, then we’ll have a place to discuss this particularly absurd line of reasoning.
I’ve been a regular FDL reader for years and years, and have been watching these “biosimilars” threads for weeks now. These threads would be pretty entertaining if the topic weren’t so tragic.
It’s really disappointing to see how easily our community falls into the same knee-jerk demonization and quashing of contrary opinions we used to see on LGF. Firepups didn’t used to let their fear and desperation sieze control of their reason, but apparently it’s o.k. when it’s about prescription drugs. Why are so many people reveling in ignorance, dismissing reasoned argument due to guilt by association? It’s pretty pathetic.
Count me in on the refutation bandwagon, I think Jane’s wrong on this one. I’m a proud liberal Ph.D. pharmacologist who’s willing to accept the fact that we don’t know how similar “biosimilars” really are, a fact that warrants very careful testing of these follow-ons. Waxman et al. are advocating the scientific equivalent of the repeal of Glass-Steagal, with almost as much knowledge aforethought. He, Sherrod Brown and Jane Hamsher are standing on dangerously shaky scientific ground, and everyone stands to suffer when one of these poorly tested bio-imitators goes down in flames.
So, bring on the accusations. Shill, pimp, plant, dupe. Please try to be original, though, the same old character assaults are getting pretty boring.
I think you’re missing the point of the post. YOU weren’t paid to issue somebody elses opinion while pretending it’s your own.
Your opinions are your own, based on your experience as a Ph.D pharmacologist. And they are welcome here.
I would very much like to see YOUR point debated here between Jane and someone who doesn’t have a political iron in the fire.
Boxturtle (*hint, hint*)
My sister is an education lobbyist for a major union. She “writes” positions that are often read almost verbatim by Democratic politicians in support of legislation almost everyone on the forum would support.
That reality doesn’t de-legitimize her work any more than the argument that, since no congressman has read all eight billion pages of the healthcare legislation, they shouldn’t support it. Rapid legislative action sometime require legislative shorthand. Picking and choosing when that’s acceptable is hypocritical.
If they don’t know the issue well enough to state it themselves, then they shouldn’t be submitting white papers into the record. There’s no reason to do so–except to suck up donations. I don’t even have staff and I’m able to come up with informed opinions on this stuff–why aren’t Congressmen?
Umm, maybe because Congresspeople hire staff to do PR work more than staff to provide scientifically informed advice?
There are exceptions… and I imagine that committee staff is better analytically than office staff.
You also have the benefit of engaged and educated commenters, where a Congressperson may see PITA constituents, FDL sees a chance to learn.
P.S., if anyone can search comments for my username, miine include many of the points I’d reiterate here if I had the typing skills.
I respectfully disagree.
It’s going to be a long process but the ultimate fix in my opinion is to get prescription medications out of the unlimited profit business. Whatever can be done to begin to disempower the pharmaceutical industry is a worthwhile effort.
The Eshoo amendment and so much begun by Reagan will and has done much damage in virtually turning over to traditional market based corporations control of life essential medications.
apples and oranges. I’m talking science, you’re talking economics.
You, so far, have talked about scientific generalities, not science. Then you act like your scientific generalities, even assuming they are correct (which there is no data backup presented to support such a conclusion) trump other considerations, such as economics and public interest. So far you act all high principled and heavy handed, but don’t have squat behind your words.
Thanks for playing bmaz. Got a specific question, or are you just playing bitch slap politics? (ht to TPM)
If you want you can time my response to your post so you’ll know I’m not going to wikipedia to look up what words like “glycoform” and “immunogenicity” mean. (hint, they’re critical to understanding biologic drug comparability)
Looks like it’s time for our Ph.D. pharmacologist friend to get back to playing with his chemistry set.
At this point, I strongly advise everyone to take a deep breath, put pejohb’s bullshit in perspective, and do the only appropriate thing we can: ignore it and wait for it to go away.
we have a winner.
I’m not dismissing pharmacologists.
I’m dismissing you. See ya.
Right back at ya bubba; you are still spewing generalities and and strung together trade terms of art and catch phrases in a false attempt to act as if you have successfully argued, supported and won your point. You have not. But hey, if it makes you feel superior to pitch such hollow shells and technical non-sequiturs, have at it.
Nope. I have a different take.
In all due respect, you are so close to the subject that you seem to be accepting as immutable just what needs to change. That is my larger point.
In fact the science is largely irrelevant to undoing Eshoo
I’m willing to admit that you may be right, I may be too close to this issue. But couldn’t that also be said of you? My understanding is that you’re a practicing oncologist. Might you so want a cure for your patients that you are blinded to other arguments? Alternately (and more in line with what I face every day) does your undeniable financial stake in patient care play a prejudicial role in YOUR positions? (Don’t physicians make LOTS of money off sick people?).
In my defense, I can provide peer-reviewed evidence supporting my scientific positions, but all I see are invectives and “truthy” arguments from the anti-Eshoo amendment crowd.
Where is all your ballyhooed peer reviewed evidence? So far, all you have pitched is glittering generalities; although I will give you some credit for getting progressively more reasonable in how you do so.
Most of that reasonableness apparently having come from us shooting specifics back!
Where’s freep when we need him?
No I no longer practice nor do research.
I cannot however disagree to, in some aspects, being too close to the subject. I know most of us here have reasons that this is an issue of personal as well as political concern. The many differing perspectives i find useful to better understanding and ideas for solutions. Many of my views have changed through the years.
That is why civil discussion with much listening as is possible in this venue is so useful. It has been interesting as I have noted how many of my views have changed.
Hear, Here! A mature individual speaks!
Bob in AZ
The issue with Eshoo’s legislation isn’t with the definition of bio-similar, and regulatory control assuring that these medicines really are similar is not a problem. No one is saying that biosimilars shouldn’t be assayed and analyzed to assure they are the same as the reference medication. We are saying it makes sense to minimize duplication of clinical trials.
Eshoo is correct that “changes in dosage, route of administration”, etc don’t give evergreen exclusivity. She completely ignores that minor structural changes give PhRMA the ability to restart the clock. Due to this I’ve got to side with Jane, Eshoo is only correct in a narrow technical sense, Jane is right on the essential issue of evergreening.
The problem is production using the same technology that meets requirements cannot piggy back on the reference medication’s clinical data. This is a barrier to competition and allows monopolistic pricing. The biggest argument has been whether Eshoo bans “evergreen” exclusivity – the language has a big loophole for “structural changes” including PEGylation, a process that is well understood and cheap. Continuing to give effective monopoly control for changes that can be done in a High School lab is ethically wrong; it’s putting excessive profits ahead of health. So a company PEGlyates its medicine, now there is a barrier for entry for not only the PEGylated medicine but the reference medication gets another 12 years in te bargain.
Schumer offered much better language (he actually bothered to define what changes restart exclusivity).
The approval for biosimilars is the same, for one and the other. The big difference is how big a disincentive to give to real research.
But you can take the anti-innovation stance, that’s allowed here.
Thanks Marcy, that was pretty creative. I really do enjoy your perspectives on the law and government secrecy, your Libby coverage was tip top. It’s a real honor to have been backhanded by you.
As to innovation, are you referring to the same science that elicits such widespread pearl clutching when it’s described in the context of GMO’s? If so, please explain why it’s so critical that we thoroughly and unequivocally test GMO foods, but poorly characterized drugs derived from molecular manipulation are a.o.k (even though there’s no peer reviewed evidence of their safety)?
You completely ignored my point–and that of several others on this thread. So I assume you’re conceding the point.
The standard for approval is the same.
There–that was simple. Simple enough for you to understand? Because so long as that’s true, you are still defending the anti-innovation stance.
ah, I see you’ve spent some time on DU.
What i read in the Eshoo amendment is a perfectly defensible scientific position, that the FDA should be given the right to oversee and define the criteria for biosimilar approval.
You’re talking about skipping a scientifically critical review of a new technology to assess the best regulatory path forward. Yours is a Luddite position, mine is based on a deep knowledge of the tragedies that have occurred when antiquated standards of regulatory oversight were applied to biologic drugs. Google EPO, immunogenicity, and pure red cell aplasia.
pejohb
You can continue to misrepresent and misdirect from what I–and everyone else here–has said.
But I doubt you’re convincing anyone by continuing to pretend this is about the review process and not the monopoly. You can insult people here all you want. But if you can’t address the core of the issue you concede your own inability to do so.
This surprises me Marcy. If anyone reading this thread should understand that the legislative details ultimately drive the larger picture, I would think that person would be you.
I’ve yet to mention the “monopoly” you suppose would evolve from the current legislation because it has yet to be demonstrated to my satisfaction that the Eshoo amendment would lead to such a beast.
Instead, what I see proposed here is a solution of expediency, based on the gut feelings of very poorly informed advocates with political agendas and biases every bit as powerful as those on the other side of the argument. Is this how you want laws made? Didn’t we just go through eight years of this?
To me there is a tremendous need for changes to the current system, but I have limited my comments to areas of this discussion about which I have appreciable expertise. Specifically, arguments are being made here that there is no scientific justification behind the amendment. That is quite simply incorrect.
There is no scientific justification for the exclusivity time periods.
Those time periods have nothing to do with science. They have to do with economics and pricing power.
Assuring safety and efficacy is something we all want to be done scientifically.
I’m against people dying on the Mammon’s altar with legislative cover.
You’re still playing straw man, pejohb.
Yeah, well, it turns out that is exactly how legislation is crafted and laws made in Washington. Secondly, the argument being proffered here is not so much that there is “no scientific justification” (although for all your yammering you have provided little, if any, scientific justification); so much as it is that the public good and human equities militate against your positions.
I don’t see that Marcy. Pointing out the fundamental innacuracies at the basis for an argument is hardly a straw man. I’ve been reading Jane’s posts on biologics for some time now, and they are, quite simply, scientifically inaccurate. Given that the core of the arguments being made depend upon the assertions being true, I think it’s perfectly reasonable to point them out.
The part of this that bothers me is that there are so many reasons to change laws on evergreening, patent life, and reimbursement. Good, moral, and ethical reasons. But that’s not what being pushed. What’s being pushed is the idea that there is no scientific justification for the proposed legisltation. Again, this is quite simply and demonstrably incorrect.
The arguments being made by Jane and others, namely that biosimilars are similar enough, is based on faith, not science. The repeated implications that anyone who questions these false assertions is some kind of profiteer of death is not something I expect from this blog.
We aren’t arguing that biosimilars shouldn’t be regulated.
it’s a strawman to say we oppose regulation for safety and efficacy. We agree with you that there needs to be regulation for safety and efficacy.
Please tell me why 12 years exclusivity is scientifically better than 5 years.
The issue with Eshoo has nothing to do with FDA defining criteria for approval. We’re happy you like knocking down strawmen, we agree that there should be regulation to assure a biosimilar is good medicine.
The issue is how long clinical data (Intellectual Property used to gain approval) will be a monopoly.
Eshoo said 12 years. Schumer said 5. FTC said 0.
Exclusivity gives pricing power. Which leads to choices between dying and bankruptcy. An estimated cost difference of $71B over 10 years being one difference between 12 year and 5 year exclusivity… that money represents either profit to PhRMA or bankruptcy of sick people (or higher premiums).
Is it really exclusivity if no other drug meets scientifically reasonable criteria for biological similarity?
I think it’s reasonable that we ask Teva et al. to show their bio-similar is not an inferior or more dangerous product. IMO, if it’s not close to the same as the pioneer drug, then it should go through a unique approval process. Eshoo’s amendment put some damned reasonable boundaries on that definition. If it were up to me, there would be even tighter controls than those proposed.
Tell me why Schumer’s language is worse.
Why is 12 years exclusivity superior to 5 years for public health?
I like seeing your straw man lying on the ground (pun intended).
I seem to recall that during previous administrations, Big Pharma was arguing that the exclusivity clock should start running when the patent is granted, the assumption here being the other side of the argument was that the clock started earlier than that. (I probably have this wrong somewhere.)
I think that even if it takes as long to get a drug to market as Big Pharma claims, they still shouldn’t get more than 5 years of monopoly on it, since they’re making profits off publicly-funded research.
You know that they’re always tweaking drugs for dosage, timing, and new uses, so those shouldn’t be excuses for extending patents.
This pejohb ignored all four of my points @ 63 when responding @ 66.
We’re not speaking with a reasonable person who wants to engage in constructive discussion, but with someone who thinks that throwing out scientific jargon is an effective substitute for dealing with the complexities of this issue.
Again, I really think we should ignore it and wait for it to tire itself out and go away.
thanks Marcy, I love you too.
The “jargon” you deride is at the core of the biosimilarity issue, a fact to which several other posters here could probably attest.
I know it’s a radical idea, but maybe listening to an informed but contrary perspective from your own side of the aisle would ultimately strengthen your arguments?
I want patient access to lifesaving drugs to increase, I work towards that goal every day in the lab. I also believe that the approach being espoused here and by Reps Brown, Waxman, and Ms. Hamsher is ill-informed and likely dangerous.
Dismissing people who make economic arguments or moral arguments or who try to engage you in debate on your terms in this discussion by saying that they’re “playing bitch slap politics” and by mocking them by making references to Wikipedia or by just plain ignoring their arguments says infinitely more about you than anyone else here.
If you really give a shit about increasing patient access to lifesaving drugs and want to help others avoid advocating what you believe to be dangerous approaches to dealing with serious problems, then start acting like an adult and use your knowledge to inform us.
Where’s the incentive to do peer reviewed studies of biosimilars if there is no way around the exclusivity?
It sounds like you are arguing for full scale duplication of clinical trials for any biosimilar medication.
P.S., the approval process may be bureaucratically the same, but applying the same standards used for small molecule drug approvals to biologics is scientifically unsound.
There is a complete and utter absence of data surrounding comparability studies for biologics. Teva (Israeli Big Pharma) and Dr. Reddy’s (Indian Big Pharma) would love to have you belive there is, but it just isn’t so.
So you’re saying Congress got it wrong? How do we avoid monopoly via regulation – or is this not worthwhile?
Full clinical trials needed for any biosimilar? 12 years? 5 years? 0 years? PEGylation restarts clock?
Until we know more, yes, PEGylation should re-start the clock. PEGylation is a huge alteration to a molecule. Normally it actually reduces immunogenicity, but the impacts on exposure-response relationshis demand much more in-depth study than that required under generic approval guidelines. It would save a bit of time, but you don’t have to trust me on that, it’s in the literature.
Nobody’s saying another comprehensive phase III trial should be required for follow-on biologics, but fer chrissakes, we’re not talking claritin here.
But PEGylation doesn’t just restart the clock for the PEGylated medicine, it restarts it for the reference (non-PEGYlated) medicine.
I don’t see that, can you explain?
Also, assuming all things are otherwise equal, PEGylation is very much like a major alteration in dose. PEGylation typically extends half life, which changes the way you dose a drug (timing, target blood concentrations, etc.). Generic bioequivlency studies for small molecule drugs assume identical dosing, which is probably a reasonable assumption. Under current regs, major alterations in dosing warrant more extensive clinical trials.
So, only Ph.D.-waving scientists should be allowed to discuss legislation that would make it impossible for generic biosimilars of life-saving biologics from ever becoming available to people who need them?
And any thoughts about costs, profits and funding for research must not be allowed to enter the discussion, being dismissed as mere economics?
Give me a break. That’s about as stupid a set of assertions as I’ve ever read on this topic on any of these threads so far.
First of all, Eshoo herself spouts bullshit about the economics of it all in her painfully ridiculous counterarguments to Jane:
But the truth is that granting companies endless monopolies over the products would only allow companies to profit forever from them – products they have already developed – and would most likely be a disincentive to their continuing to develop newer and better products in order to remain innovative.
What would that do to science?
We have agencies that would test the viability of any potential biosimilar. We don’t need to show you one in order to be correct in demanding that competitors be allowed to make them and sell them to people who need them after a reasonable period of time.
“So, only Ph.D.-waving scientists should be allowed to discuss legislation that would make it impossible for generic biosimilars of life-saving biologics from ever becoming available to people who need them?”
Exactly the opposite is happening here, Ph.D. scientists are being dismissed as whores and shills for daring to contradict Jane. What I’m saying is that populism has no place in science. Touting the scientific bona fides of a medical student association does little to bolster ones arguments regarding complex problems in drug development.
No, you refuse to address very basic point, and continue to mis-represent the content of the amendment. Stating you have a PhD does not make the rest of us illiterate or blind.
No one here has accused you of being a shill. We’ve pointed out that you–someone in this field–not only can’t refute our key point, but repeatedly misstate it and misstate the content of the bill.
A PhD does not excuse dishonest argumentation on this thread, sorry.
I wonder what the approval process for blood transfusion would look like today?
We assay blood via fairly simple immune system testing. Why aren’t biosimilars subject to immunoassay techniques? Which is how we assure vaccines (biological medicines) are similar…
The QA process used for the reference medication is up to the job of assuring consistent action of a biosimilar. Quit blowing smoke.
pp 1537 lines 10-25, 1538 lines 1-17 in HR3962 on October 29, 10:05 AM version.
The language may have moved around in the final bill, starting with
(my bold)
section (C) (ii) (I) (pg 1538, lines 8-10) says PEGylation would restart the clock for the Reference Product
Not the structurally modified product. Schumer got this right, Eshoo got it wrong.
I’m going to look at this, thanks. A quick Google search did find the FDL post from which I think you got your text, and I’d like to point out an error therein:
“It should also be noted that the Eshoo language does not require a change to the amino acid structure of the biologic — the scientific definition of a truly new medicine — in order to allow a brand product to obtain a new 12-year monopoly.”
This is untrue on several levels. Putting aside that there is no “scientific definition of a truly new medicine” for a moment, it’s been known for decades that there’s more to protein function than amino acid sequence. Again, this misinformation is at the heart of the similarity comparison being made. It’s not the primary sequence, it’s all the other things that happen to a protein in cell culture that cause the problems. the devil is very much in this particular detail.
Which branch of Big Pharma do you work for?
ah, yes. Thanks PJ. Your work is done here.
The language is unchanged from Eshoo’s stand alone biosimilars bill.
You’re deliberately ignoring what other posters are arguing.
We agree that biosimilars should be regulated for safety and efficacy. No one has objected to regulation with those ends in mind. You keep putting up this strawman.
We are arguing about how monopolistic practices that regulation promotes.
You have not argued for 12 years versus 5 or zero years. Alright then, zero years it is.
You have not argued that a PEGylated formulation should restart exclusivity on the nonPEGylated medicine. So you should be joining me in asking my Representative Anna Eshoo to address this evergreening provision in her legislation… I’ve been very disappointed with her – she hasn’t responded with how she intends to fix this problem.
I find it interesting that you conflated “amino acid structure” into “amino acid sequence” above… structure determines how a protein is folded upon itself, and I think many of us do know that sequence isn’t sufficient to determine a protein uniquely. There’s even some vague knowledge of this in the general populace thanks to Mad Cow disease.
excellent, thanks for the heads up/clarification.
For the record, I would be against any extension of exclusivity for a pioneer drug under such circumstances. Not that it matters, my being a Pharma pawn and all…
As to the sequence/structure “conflation.” it was unintentional. The same argument applies, in that post-translational modifications determine a great deal of the pharmacology and safety of a biologic drug. Making batches of a protein identical is incredibly difficult even when using the same exact cell lines and cell growth media.
It’s a quantum leap to expect that a generic company could exactly replicate a pioneer drug de novo (or even using the same amino acid sequence published in a patent). Luckily, exactitude is not entirely necessary or warranted. This legislation is the first attempt at defining the necessary level of similarity, which is why it should be done right.
Like I’ve been saying, you’re arguing about something virtually all of us agree on – biosimilars should be regulated to promote safety and efficacy.
You don’t address our objections to provisions that have to do with profitability. And that is the central issue with Eshoo’s legislation – it effectively grants long term monopolies that cause great hardships to all but PhRMA shareholders. we want that part of the legislation fixed.
I put a strawman proposal saying limit markups to 25%. That degree of regulation is politically unfeasible. The idea that IP policy shouldn’t value profit over public health is laudable. Most people given the choice between death and bankruptcy will choose bankruptcy… that doesn’t mean we should have policies that push bankruptcy.
What’s conspicuously missing from all this discussion is information on production costs of biologic drugs. How much of the $60,000 a year for Herceptin is profit? How much is amortized development cost?
The debate on exclusivity is when a prospective new manufacturer can piggyback on the original clinical data.
Duplication of clinical data for a product that is medically the same medication wastes resources.
I think I’m going to choose death over bankruptcy. What good is it being alive if you’re living under a bridge in a cardboard box?
You keep bringing up a strawman.
Maybe we should limit profit on biologicals to 25% of production costs, with development cost amortized over 5 years.
Oh wait, that’s central control over free markets – Socialism! ooga booga!
What we’ve got now looks more like profits of 30,000% of production costs. Which leads to either dead people or bankrupt people. Hooray for free markets!
I may be reading this wrong wmd, but I think you’ve got it backwards. Exclusivity is prohibited for reference products (which I believe refers to the pioneer drug):
Section 7(C): Products not eligible for 12 years exclusivity and filing moratorium.
“7(A) and (B) shall not apply to a license for or approval of-
i. a supplement for the biological product that is the reference product; or
ii. a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product) or a licensor, predecessor in interest, or other related entity) for
(I) a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
(II) a modification to the structure of the biological product that does not result in a change in safety, purity or potency.”
The clause reading “(not including a modification to the structure of the biological product)” says the prohibition doesn’t apply.
Striking “not” would fix this evergreening loophole. Schumer’s language is better in my opinion because it isn’t vague.
Hoffman (roche) was a swiss company, I believe. It got into some legal trouble in the past. This year it bought the remaining 44 % of Genentech that it did not already own – in an oiginally hostile takeover. Recently, there was an article indicting that Genenteck was not sharing data with Roche. There are a number of issues in just the above record that should cause Congress members to be concerned.
OT: Kareeem Abjul Jabber and Novartis? I wonder if he getting paid by Novartis if that is the company. If it just takes one miracle drug a day to keep him alive – I wonder how much costfor just an average person with the same disease?
I would look at it a little differently. Kareem Jabbar is now on the level field. Desperately seeking ways to live a little longer and more money with which to purchase it than there are ways to accomplish it. Who can criticize?
If in the years he has left perhaps he will use his visibility to make the case for how desperate the need is for so many..
Well. That was unpleasant. Interesting that pejohb sometimes didn’t even seem to understand who he/she was responding to, @85 confusing Knoxville for Marcy and @101 confusing bmaz for Marcy.
“When the only tool you have is a strawman, all problems look like Marcy”?
I did dress up as the scarecrow for a Halloween road rally one year. That’s kind of like a straw man.
OK then, a corollary: “If Marcy has a strawman, it must be Halloween.” A highly unusual condition.
He or she certainly liked arguing against a position we don’t hold while not addressing our problems with Eshoo’s amendment (and unfortunately Kennedy’s as well).
No argument, so to speak. Though he or she did seem to sincerely believe it was a principled stand. Blind spot, maybe; we all have them, after all.
Someone asked Einstein what he thought about the Nazis putting on a program in which 100 Nazi scientists would refute the theory of Relativity. His response: “If my theory is wrong it would require only one.”
The whole biosimilars thing is a tricky business. Two chemicals can be identical in composition and structure, except that one is the mirror image of the other. And the crazy thing is that one might work, and the other might not.
And then two chemicals that are different in composition and structure might have exactly the same effect– because the business end of both molecules is the same. So the reward structure needs to provide sufficient incentives, without providing excessive profits. I don’t know enough to judge which is which, but I trust Jane.
My situation is not as life-threatening as Jane’s is/was, but presently one of my crucial medications also has unfortunate side effects. It would greatly improve my quality of life if drug research could eliminate the side effects while maintaining the functionality. The present reward structure, exorbitant as it is, seems insufficient to yield results that would be more satisfactory to me and most other men.
On the other hand, the drug industry does not like simple, easily manufactured chemicals. Something like aspirin, if it were discovered today, would not interest most Big Pharmas, because it is natural and not patentable, IIRC. The industry is way out of alignment on that score, too.
The system as it is, is rigged in favor of Big Pharma. Adjustments are in order.
Bob in AZ
The handedness of molecules is a funny thing – it really does matter, though. At a guess, the left-handed versions work better, because that’s what we use.
(I remember reading that thalidomide is handed, and one version is safe, but the other is the one that causes the problem. I don’t know how true that is, though.)
While which moiety a molecule is in can matter for efficacy there are techniques to determine you’ve produced the effective molecule. Biological processes should actually be better at synthesizing the correct moiety as well – proteins are expressed under genetically programmed controls that determine how each amino acid is placed.
Analytically determining structure of large molecules uses technology that’s analogous to how we determine blood type – immunoassay. Same technology used for low rent urinalysis for drug use (MS/GC is much superior technology for drug metabolite testing).