J'accuse! Pharma is trying to kill off the generic drug industry & getting lots of help

[Phoebe Loosinhouse]

Read the following stories and see if that isn't the inescapable conclusion.

http://www.reuters.com/article/idUSTRE5BN3A020091227
Generics chafe under big pharma's reform shadow
Susan Heavey
Sun Dec 27, 2009 4:04pm Wed, Dec 23 2009
WASHINGTON (Reuters) -
The massive Senate healthcare reform measure passed on Thursday with support from the multibillion drug industry, but makers of cheaper generic rivals are feeling left out in the cold.

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"The bill passed by the Senate unfortunately amounts to a treasure trove to brand drug companies," said Generic Pharmaceutical Association President Kathleen Jaeger, whose group represents Mylan, Watson Pharmaceuticals and Teva Pharmaceutical Industries, among other companies.

President Barack Obama has often pointed to generics as a key way to cut costs, but big pharmaceutical makers such as Pfizer and Merck came to lawmakers and the White House with an $80 billion, 10-year pact to cut prices and pay additional taxes to help fund the expansion of health insurance coverage.

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Most notable is the setback for generic versions of biotech drugs, also known as biogenerics or follow-on biologics.

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http://www.latimes.com/business/la-fi-hiltzik17-2009dec17,0,1929214.column

Biotech bonanza lurks in healthcare reform bills

A proposal by Rep. Anna Eshoo would give developers of innovative biomedical drugs 12 years of statutory protection from generic competition, significantly extending their patent rights.

By Michael Hiltzik
December 17, 2009
The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar.

Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?

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http://maplight.org/dems_senate_pharma_prescription_drugs

Dems Voting No on Prescription Drug Imports Receive More Pharma Money

December 16, 2009

Yesterday, the Senate voted against the importation of prescription drugs, 51-48. Offered by Sen Byron Dorgan (D-ND) as an amendment to the health care reform bill, the provision would pave the way for market access to cheaper prescription drugs, by relaxing restrictions on imports from Canada and other highly-developed countries. In a bipartisan effort rarely seen in recent votes on health care reform, 30 Democrats sided with 17 Republicans and one Independent to kill the bill.

MAPLight.org found that Senate Democrats who voted to block imports, siding with drug companies, received an average of $73,678 each from drug companies over the past six years—76% more than Democrats who voted in favor of imports.

Among all Senators, those voting to block imports received an average of $85,779 each from drug companies, 69% more than those who voted in favor of imports.

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The pharmaceutical manufacturing industry is opposed to drug importation, claiming the risks of counterfeit medicines and sub-standard regulations could cause undue harm to consumers. Senator Dorgan and 12 co-sponsors argue in the text of this bill that "a prescription drug is neither safe nor effective to an individual who cannot afford it." Dorgan estimates that the bill would save American consumers $100 billion over ten years.

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note how Dorgan estimates the drug importation would have saved $100 billion over 10 years. Note how that is more than the 80 billion over 10 years the White House "negotiated" with Pharma.
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But wait! There's more!

http://www.huffingtonpost.com/2009/12/15/doughnuts-for-dorgan-drug_n_393527.html

Doughnuts for Dorgan: Drug Reimportation Killed in Deal That Might Get Cheaper Drugs for Seniors
Ryan Grim

President Obama and the Senate leadership can't whip up the votes necessary to pass a public option or even a Medicare buy-in compromise, but they didn't have any trouble persuading 30 Democrats to vote against prescription drug reimportation Tuesday night --thus preserving the deal cut between the Senate Finance Committee, the White House and Big Pharma.



http://www.washingtonpost.com/wp-dyn/content/article/2009/12/27/AR2009122701206.html?hpid=moreheadlines
The not-so-sweet side of closing 'doughnut hole'
By Amy Goldstein
Washington Post Staff Writer
Monday, December 28, 2009

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Under the health-care bill the House passed in November, people who reach the doughnut hole would be $500 better off next year than they would otherwise. But the impact over the next few years would be subtler than it appears at first for two reasons: The gap -- without any change -- is scheduled to expand each year, and the bill would fill it gradually. As a result, patients would face a larger coverage hole in 2011 and 2012 than this year, according to Ways and Means Committee data. After that, it would shrink more rapidly and disappear in 2019.

The just-passed Senate measure would narrow the gap halfway. Even before the bill was approved, Reid and the chairman of the two Senate committees that handle health-care issues said they would, as part of negotiations to resolve differences between the two bills, accept the House's goal of closing the hole completely.

Congressional budget analysts have not said how much that would cost. Instead, they predicted a savings of $43 billion over the next decade -- based on the combined effect of filling the hole and two steps the pharmaceutical industry has said it would take in part under the deal earlier this year with the White House and the Senate. As one of those steps, drug manufacturers would repay the government the difference between the prices the companies charge for medicine for low-income patients in Medicare and the prices they used to charge in Medicaid, before the drug benefit existed. As the other step, the House bill requires the manufacturers to give a 50 percent discount for brand-name drugs that patients buy once they enter the doughnut hole -- and to give the government the equivalent of that money after the hole closes.

Budget analysts say the discounts for brand-name drugs would end up costing the government money; fewer people would switch to cheaper generic medicine, in turn causing more people to reach the gap's far side, beyond which almost all remaining drug expenses are covered.

[Phoebe Loosinhouse]

1. Anyone come to a different conclusion? nt

[Ms. Toad]

15. Actually the biological equivalent issue is far more complex

than the articles hint.

What is in the bill isn't an extension of patent rights (which grant a monopoly), but a period of time (after the patent expires) in which competition is permitted but competitors are prohibited from piggybacking on testing done by the patent owners.

It does make the process of entering the market with a generic biological equivalent far more expensive (since the competitor must do its own testing, rather than "borrow" the testing of the original manufacturer), but it is not a direct ban on competition in the way a patent is.

With purely chemical drugs, if it is the same chemical the generic competitors have to go through an abbreviated approval process since chemically identical products will work in identical ways, and how it works has already been proven. With biologically derived drugs, it is not such a straightforward proof, since if the biological origin is different (but similar) it may make a big difference in the results of using the drug. The bill essentially grants a 12 year period in which makers of biologically similar products are permitted to enter the market, but must undergo full blown (very expensive) testing using their own data. That will, in effect, mean that all but the most well-heeled generic competitors will avoid the market for that period - but they are not barred from doing so.

(That's a 10,000 foot view - so don't rely on the details, but I did research the issue when I first started hearing about so-called "patent extensions" from someone who was concerned about a "patent extension" for a biologic drug she was taking).

I haven't done enough research to determine whether I think the 12 year period is needed at all, the appropriate length, etc. My concern at the time I was doing research was the assertion that the patent term was being extended (or the period in which competition was forbidden), and it is not.

[chimpyisstillsatan]

19. almost exactly correct

another facet is that the law mandates that FDA establish rules for determining what exactly is similar enough to be considered a "generic" biologic drug. Take it from me, a Ph.D. scientist with 23 years experience studying antibodies, achieving such bio-similarity is no small feat, and is a critical safety issue. Ramming the square small molecule generic drug laws into the round hole of biologic drugs is a recipe for disaster for patients.

[Vidar]

2. K&R.

[global1]

3. Does Waxman Have A Position On This Cause If I Recall He Was Big In Getting Generic Drug ......

legislation passed in the first place?

[Phoebe Loosinhouse]

4. Waxman was furious at Eshoo who did an end run around his version

of her amendment. He promoted five years of Patent protection, The FTC reccomended none, the Obama administration said 5-7, but Eshoo went for 12 and got it. I read an article when it happened how she jumped protocal and insisted on a recorded vote for her amendment, which apparently was quite unusual. My take at that time was that it would put on record who was obeying their Pharma overlords and who was not. I'll try to find that article, it was very telling.
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From out of the BioPharma's own mouth:

http://www.biopharmatoday.com/2009/08/followon-biologics-defeat-for-waxman-win-for-health-reform-.html
August 04, 2009
Follow-On Biologics: Defeat For Waxman, Win For Health Reform
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Rep. Henry Waxman, D-Calif., can perhaps take some comfort in the fact that his defeat on follow-on biologics means his broader health reform legislation may have a greater chance of passage.

At the July 31 markup of the health reform package, H.R. 3200, Waxman saw Rep. Anna Eshoo's rival amendment on a follow-on biologics pathway adopted overwhelmingly, 47-11. Among other differences, Eshoo's proposal would give innovator products 12 years of exclusivity, while Waxman's own FOB bill offers five.

The vote was good news for the brand industry - but also is good news for the health care reform legislation overall, since the pharmaceutical and biotech industry now have a much stronger interest in seeing the bill pass.

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Another surprising and disheartening point for many people like me who had previously come close to idolatry in my regard for Dr. Howard Dean was his support for the Eshoo Amendment, which this blog does a good job of summarising

http://www.keionline.org/blogs/2009/07/20/howard-dean-as-a-shill-for-bio-on-biosimilars-bill
Howard Dean as a shill for BIO, on Biosimilars bill
Submitted by James Love on 19. July 2009 - 22:00

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In his e-mail to board members, (BIO President & CEO) Greenwood did not fail to include Dean in his praise. “Our team at BIO, the D.C. offices of our members, our consultants (now including former Vermont Governor and Democratic National Committee Chairman Howard Dean) did a magnificent job,” he wrote.

Dean signed on as “an independent consultant exclusive to the government affairs practice at McKenna Long & Aldridge LLP” in March 2009, according to the law firm. BIO’s Joseph told BioCentury McKenna has a contract to provide “general strategic consulting, messaging advice, and communications strategy” for the trade association.

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“Governor Dean was very helpful to us” as BIO scrambled to respond to the Kennedy amendment, he told BioCentury. “As a physician clearly focused on healthcare, a Democrat leader and clearly to left of center, his efforts were impactful.”

“Dean has been a great addition to our team,” Stephen Sherwin, chair of BIO’s executive committee and health section, told BioCentury.

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I think Waxman looks like a hero in all this. He just didn't prevail.

There is nothing like examing healthcare bills to see the seamy underside of the American political system.

[Phoebe Loosinhouse]

5. kick!

[Nikki Stone1]

7. +1

.

[avaistheone1]

12. Shame on Eshoo.

Is there anything we can do at this point?

[chimpyisstillsatan]

21. political litmus test anyone?

So Waxman, with no scientific education, demands the politically correct, anti-Pharma version and he's a hero? Meanwhile, scientifically trained Howard dean is a Pharma shill for his position?

Sounds like political litmus tests in questions of science. Now, where have I seen that in the past decade...?

P.S., Did Hank return Amgen's donation, or is he a Phrma whore, too? What about the money he took from AstraZaneca? Gilead? Lilly? Allergan? Mylan? Pharmaceutical Care Management Assn.?

http://www.opensecrets.org/lobby/lm_memsclients.php?id=N00001861

http://www.opensecrets.org/politicians/contrib.php?cid=N00001861&cycle=2008&type=I&newMem=N&recs=100

[Phoebe Loosinhouse]

6. evening kick.

[2 Much Tribulation]

8. the intolerance toward generics is quite palpable (and inexplicable except via lobbying/bias) nt

[Ms. Toad]

16. I seem to recall a thread within the last two weeks

in which a DU member was receiving lots of sympathetic outrage at being forced to pay more if she wanted to use a brand name, rather than a generic...

[andym]

9. They should have eliminated any extra protection for biogenerics

Patents give 20 years of protection. Even if if takes 6-8 years to develop a drug, that leaves 12-14 years to make a hefty profit. That should be enough.

One point though, this bill does not affect small drug generics (which are most/all of the current market for generics),
these generic makers are not threatened.

[Phoebe Loosinhouse]

10. But most people think the drugs of the future will be biologics

so these limits will have huge impacts going forward.

[chimpyisstillsatan]

20. it's the pioneering work that takes a decade,

and once a target is "validated" by a decade of discovery, optimization, and clinical trials, it's relatively simple to whip up an imitator drug. Unlike with simple chemical compounds, it's essentially impossible to make the new copycat antibody drug biochemically identical to the drug that was first approved. Those differences, even minute ones, can mean life or death, safety or toxicity.

So if Teva (Israel) or Dr. Reddy's (India) or Crown Bio (China) want to whip up an antibody to mimic the pioneer drug, it could happen in a matter of 18 months if the generic companies get their way. Determining the safety of a knock-off can (and should) take years. So a decade of pioneering work could be shot down in two years or so by some Haitian bio-generic company.

The Eshoo amendment outlines the regulatory oversight that the FDA has to establish what exactly is a safe and effective "bio-similar" drug. From a scientific perspective, this should entail more work than is done for small molecule drugs.

The patent law issues are a separate discussion altogether.

[andym]

23. That the "pioneering" work can take a decade is misleading

I actually work in the development of new biologicals and the "pioneering" work is usually done by others, especially academics who help identify the key targets (or small companies that try to create novel plaforms). Many of the key potential targets are well known (although there are exceptions). For example, to create an antibody to block the target (and do the preclinical animal work) should not take more than 2-3 years, especially at a well-funded company. The approximate 4-8 year clinical trials are the major sticking point.

As for the similarity of the drug. If it is protein-based, contains the same amino acid sequence and is produced in the same or similar cell type (usually CHO cells or E. coli for most of the existing products) under GMP conditions, the product should be similar enough to use the pre-existing clinical data (with no safety concerns)

So I feel the current patent protection is enough.

[chimpyisstillsatan]

29. clarification

Maybe my use of the term pioneering is confusing? By that I mean the company that develops a first-in-class biologic (a.k.a. a pioneer drug), not the people with the original idea or the first antibody clone.

It looks like we're pretty much in agreement as to the development time, though. As someone involved in the earliest stages of biologic drug development(target ID through lead optimization and pre-clinical proof of concept) I agree that it "shouldn't" take more than 2-3 years to get to the clinic. It usually does, however, even at huge, well-funded companies.

It's certainly possible to get an E. coli product like insulin to behave properly in a generic format, but as EPO taught us, glycoproteins are a completely different ball of wax.

I hope it's not out of bounds to suggest that you do a bit more reading on the immunogenicity impacts of variable glycosylation in protein drugs. All the GMP compliance in the world won't make a HeLa cell or 293 cell produce an identically processed protein as that made in a CHO cell, even if the Chinese or Israeli manufacturers manage to get the cell culture conditions the same on scale-up (hint: they won't).

[leftstreet]

11. K&R

[Jakes Progress]

13. Business as usual.

Don't expect an apology. Just apologists regardless of how much they protest the term.

[midnight]

14. Give us brand name drugs at generic prices-NOW!

[defendandprotect]

17. I believe it -- greed knows no end --

and it seems that they might be willing to have crap generics made which will

not work for patients -- and or do them harm -- in order to get thei right wing way!!

[David Zephyr]

18. And it was Democrats that did this. Wake me up from this upside down world, someone.

I'm truly filled with despair on the state of my party.

[Black-Eyed Susan]

22. Why the surprise

Doing the bidding of Big Business is a long tradition. It's really not upside down at all. In fact this kind of stuff is easier to get through with The Dems as the opposition usually shrivels away thinking that they are in good hands with the purported liberals at the helm. You been played and it's gonna continue until enough people get off the merry-go-round.

[uppityperson]

24. welcome to my Ah list

[Black-Eyed Susan]

25. Sounds like

the makings of a witch hunt.

Color me listless.

[uppityperson]

26. Ah. sounds like

cluelessness or obtuseness. No hunting, just watching.

[uppityperson]

27. You insult then put me on ignore? Sounds like tactics of a

person who deserves to be on my list

[uppityperson]

28. 'Tis a short step from Ah to hahahaha list. Bye bye