There’s a shit storm going down on TV right now on CSPAN as the health care bill hits the floor of the House.

Thank you Democrats, for making women take a punch in the throat from a bunch of old men who have spent the better part of the last century avoiding their own problems. So Rahm and Obama (who did nothing to stop it) can have their “w”:





Well, you have to give the culture warriors something, so they can go around cheering about the big victory that they got in this bill. So happy to have the chance to line it all up for you all.

Thank you, Planned Parenthood and NARAL, from the bottom of my heart, for sitting on your hands and enabling this shit. Hope you have fun at all those Common Purpose meetings, those cocktail parties at the Pelosi’s.

You own this one.

It’s not like they haven’t been perfecting this act for a long time. Helping the Democrats stay in power by giving them the Official Good Gyno Seal of Approval even when they do things like — oh, I don’t know, voting for Samuel Alito and tell rape victims to take a cab to another hospital if they want to get Plan B contraception.

Could they whip the pro-choice women to block the rule if they want to? Of course they could. Yank their endorsements and they could cause havoc in the Democratic party. But they won’t, because Nancy Keenan and Cecile Richards value their own personal position in the veal pen pecking order WAY too much for that.

One of the things that made a fight for a public option possible was because there were no “veal pen” validators occupying the health care space. Nobody knows who HCAN is. The White House tried to press the unions and other veal pen groups into service but progressives standing there ready to shoot on sight made everyone else back away for fear of losing their own credibility.

People think the “veal pen” phenomenon is insignificant, but it’s not. The abortion fight — like the environmental fight — is extremely difficult to wage online, because you can’t activate those who care about the issue if the “brand names,” the issue validators, are telling them everything is fine either by action or inaction. And that’s exactly what the Democrats — from the White House on down to Nancy Pelosi and the House leadership — want right now.

But let’s be clear about this. The only reason that we are in the position where the price of passing health care reform is allowing even liberal Marcy Kaptur to sneeringly dismiss choice activists as narrow class warriors who don’t care about working women is because Planned Parenthood and NARAL have allowed it to happen. They collect millions of dollars in revenue each year. They’ve exacted no price from the Marcy Kapturs of the world, who actually have to care what liberals think of them, and focused instead on anti-choice Republicans who are only empowered by their ire. They have no scalps. There is no price for bucking Planned Parenthood and NARAL. It isn’t a fight that the Democrats want to spend “political capital” on, and these groups insure that they don’t have to.

Forget about the fact that more Americans are now anti-choice than pro-choice for the first time since Gallup has been polling the issue. More and more Democrats in Congress each year are anti-choice, despite the fact that the party is . It’s acceptable now. These groups have the lobbyists, the money, the access, and their leadership uses it for their own personal advancement while the cause they purport to defend withers on the vine.

The national Planned Parenthood organization listed $126 million in assets in 2007. Cecile Richards made $385,163 (PDF). The state chapters whose employees put their lives on the line so women can have the right to choose deserve support and protection within the Democratic party that she is not providing.

NARAL paid Nancy Keenan $145,538 from the Foundation (PDF) in 2007, which listed total assets of $4,119,329. But the NARAL PAC reports $87,125 cash on hand as of September 30, 2009.

They knew this was coming since at least July 1 — and they didn’t even raise money for the fight.

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The decision could be that insurance companies who offer plans covering abortion on the exchange would be allowed to turn down customers using affordability tax credits. This would create a dangerous loophole for the new guaranteed issue rule. This could lead to the ghettoizing of the health insurance exchange. Insurers would know that offering plans that cover abortion would prevent low income Americans from being able to sign up. Low income Americans tend to have higher medical costs and are less profitable, less desirable customers. Offering abortion coverage would be a simple way for an insurance company to keep them out of their risk pool. Since the exchange has dangerously weak risk adjustment mechanisms, this Stupak Amendment could become a profitable tool used by insurers to discriminate against low income Americans.

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Ten years ago today, they repealed Glass Steagel. It was a landmark, bipartisan bill. Here's what the NY Times said about it at the time:






So, how did all that bipartisan comity work out for us?

Maybe the Senate ought to stop its business for a couple of minutes today and give a round of slow clapping to the six Senators still in office who had the foresight to vote against that hideous piece of garbage. Not that they would ever do it, of course. If there's one thing that will never be forgiven in Washington is being right about something when almost everyone else was wrong.

Sen. Chris Dodd (D-Conn.) on Thursday penned a letter to Health and Human Services Secretary Kathleen Sebelius demanding an explanation of reports that Wall St. firms received many doses of the swine flu vaccine.

On Monday, BusinessWeek reported that 13 corporations including bailed out investment banks Citigroup and Goldman Sachs had received over 1,400 doses of the scarce flu vaccine. 42 million Americans who are at high-risk for the virus while 35 million doses of the vaccine have been distributed. Hospitals and clinics have reported shortages of the vaccine.

"It is hard to believe that at a time when even the most vulnerable in our society are unable to obtain H1N1 vaccinations, the government is sending doses to private firms on Wall Street," said Dodd in the letter. "People are frustrated by the government’s response to this crisis, and with news like this, who can blame them?"

On the other side of the Hill, Energy and Commerce Health Subcommittee chairman Frank Pallone (D-N.J.) said he would hold a hearing on the issue on Nov. 18. Dodd is a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee.

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Liberal groups such as the Service Employees International Union criticized the distribution of the vaccines to Wall St. firms.

A Goldman Sachs spokesman said the company intended to distribute the vaccine to high-risk individuals. But Dodd called on the Department of Health and Human Services to "review its policies to ensure that healthy stockbrokers aren't using doses meant for pregnant women and schoolchildren."

According to the Centers for Disease Control and the World Health Organization, children, young adults, the elderly, and pregnant women are among the high-risk population.

Dodd also said that the firms should return the vaccination doses they have already received.

Full letter after the jump:

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Local congressman John Carter, speaking to NBC News, confirmed that there had been a shooting at the base, saying the gunfire had erupted during a graduation ceremony.

The BBC's Adam Brookes in Washington says there are military police and Swat teams on the scene, and the FBI is on the way. Schools in the area have also been locked down.

(CNN) -- Paraguayan President Fernando Lugo on Wednesday ordered the replacement of top military commanders, a day after publicly dismissing rumors circulating the capital about a military coup.

The announcement came from the armed forces themselves, not the president's office.

In his capacity as commander-in-chief, Lugo named replacements for the heads of the army, air force and navy, according to a statement from the armed forces.

One day earlier, Lugo had addressed -- and dismissed -- reports of a possible coup.

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In May 2004, a former candidate for the New York State Legislature named Cynthia Pooler founded November Victories and Democrat Unity, online forums for new candidates who were running for Congress as Democrats.

"Before you knew it, candidates started talking about the difficulties they were having with the Democratic Congressional Campaign Committee and the Democratic leadership," Pooler said.

According to Democratic candidates who ran for House of Representative seats in 2006, Rahm Emanuel, then head of the Democratic Congressional Campaign Committee, took sides during the Democratic primary elections, favoring conservative candidates, including former Republicans, and sidelining candidates who were running in favor of withdrawal from Iraq.

Appointed as head of the DCCC by then-House Minority Leader Nancy Pelosi, Emanuel spearheaded the Democratic Party effort to regain control of the House of Representatives during the 2006 election cycle. Emanuel claimed credit for the Democratic takeover and was promoted to chairman of the Democratic Caucus, the fourth-highest ranking position in the House. But his election tactics have been criticized by progressive activists and former Congressional candidates.

According to his critics, Emanuel played kingmaker by financially supporting his favored candidates during primary contests with other Democrats. His critics say that this interference was in direct contradiction of a DCCC policy to "remain neutral" in party primaries.

According to Doug Thornell, spokesperson for the DCCC, "The policy of the DCCC is not to get involved in primaries, unless there is an unusual circumstance that demands it. I cannot speculate on what those circumstances might be. The majority of these cases <2008 primaries> will be left up to the voters on the ground. Meddling hasn't taken place this cycle, and for the most part last cycle. That isn't an accurate way to describe what happened. We are cognizant of having local support for our candidates."

Howard Dean, chairman of the Democratic National Committee, would not comment on the DCCC's alleged interference.

However, a source close to the DNC indicated that there was disagreement between Dean and Emanuel over election tactics. In his recent book, "The Thumpin'," Naftali Bendavid, a journalist who spent months inside the DCCC operation and at Emanuel's side, reported a heated conversation between Dean, Emanuel and Senator Charles Schumer (D-New York) regarding election strategies of the DCCC and the DNC. At the time, Dean was focusing on helping local organizations across the country to mobilize their communities to support Democrats. Emanuel wanted to focus the resources of the national party on specific races that were the most likely to be competitive for Democrats. According to Bendavid, Emanuel said to Dean, "You're nowhere, Howard. Your field plan is not a field plan. That's fucking bullshit ... I know your field plan - it doesn't exist. I've gone around the country with these races. I've seen your people. There is no plan, Howard."

How Emanuel came to his decisions about which candidates to support against Democratic opponents is known only to Emanuel and his staff. Emanuel declined direct comment on this story. But an examination of individual races reveals a pattern of financial and political support for wealthy conservative candidates and an assault on their grassroots-supported opponents who were running on platforms that included a full withdrawal of US forces from Iraq.

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Illinois's 6th District: Christine Cegelis vs. Tammy Duckworth

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"To tell you I didn't take it personally is wrong," Cegelis said, adding, "this was the wrong way to choose a representative. It is wrong of parties to exclude people from the primary elections. The primary is the time for the people to choose who is on the ballot; those decisions should not be made in back rooms."

Bendavid goes on to quote Emanuel saying of Cegelis, "If she would only work as hard as she would goddamn whine.... She's the only one who says, 'What can you do for me?" adding, " could absolutely win. She's just not doing it."

Emanuel's assertion about Cegelis's work ethic was hotly contested by members of her campaign.

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Florida's 13th District: Jan Schneider vs. Christine Jennings

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California's 11th District: Jerry McNerney vs. Steve Filson

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Florida's 16th District: David Lutrin vs. Tim Mahoney


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While Emanuel is given credit for turning power over to the Democratic Party in the House of Representatives, the majority is fractured.

Many of the candidates that Emanuel helped elect have joined with a group of self-styled conservative Blue Dog Democrats and have cast key votes with Republicans and stymied Democratic efforts to end the occupation of Iraq and the Bush administration's warrantless wiretapping program.

Thirteen of the Democratic members of the House elected in 2006 joined The Blue Dog Coalition; a group that, according to its spokesperson, has no official stance on withdrawal from Iraq or the president's warrantless wiretapping program. However, 30 out of 47 of the Blue Dog members broke with the majority of Democrats and cast votes in favor of the recent Protect America Act, a bill that greatly expanded the power of the executive branch to spy on Americans. The caucus also broke with the majority of Democrats when 40 of the Blue Dog members voted to continue funding the occupation of Iraq without a timetable for withdrawal.

In an interview shortly after his election, freshman Blue Dog member Tim Mahoney told the Charlotte Sun, a local paper from his district, that he attended a meeting with Speaker of the House Nancy Pelosi and told her "The president should be free to maintain troops in Iraq, if the purpose is to thwart terrorism."

Sen. Mary Landrieu (D-LA) has never been a fan of the public option. We now know that she is actively working to kill the public option with help of Olympia Snowe (R-ME) and, of course, the trigger.

“What we have to move forward thinking about is, as the president has said, people keeping what they have if they like it, having more choices, reforming the private market,” Landrieu said. “And if we can achieve that through private-sector reform, that’s wonderful. And if not, then there should be a mechanism that basically, I guess, guarantees it, which would be a well-crafted trigger.”

Given Snowe’s and Landrieu’s extreme opposition to the idea of a real public option, we know a “well-crafted trigger” must mean one that is designed to never be pulled. Snowe’s original trigger amendment was crafted in a way to insure that it was never pulled. This should not be surprising. Snowe has repeatedly stated that she is so strongly against a real public option that she would filibuster the bill she helped write if it included one. She claims her inspiration for the public option trigger is the public plan trigger in Medicare Part D, which, guess what, has never been pulled.

The trigger is not a compromise. It is not the threat of a public option. It is not the possibility of a public option. It is not an eventual public option. It is nothing more than a ruse to pretend that they did not completely kill the public option.

Democratic Louisiana Sen. Mary Landrieu is out as keynote speaker for the Palm Beach County Democratic Party’s annual fund-raising dinner next week because party leaders dislike her stance on health care reform, county Democratic Chairman Mark Alan Siegel said today.

Landrieu, a moderate who recently described herself as “extremely concerned about a government-run, taxpayer-funded, national public plan,” has not committed to voting to cut off a likely Republican filibuster and forcing a vote on the legislation.

Democrats need 60 votes to invoke “cloture” and force a vote.

“We just didn’t want to have a keynote speaker who’s not committed to cloture. It would have just been wrong,” said Siegel, who said party higher-ups and rank-and-file members had voiced displeasure with the choice of Landrieu as a keynoter.

Landrieu’s office couldn’t be reached this morning.

The Democrats’ annual dinner — formerly known as the Jefferson-Jackson dinner but this year rebranded as the Truman-Kennedy-Johnson dinner — is Nov. 14 at the Palm Beach County Convention Center.

Asked who will be the keynoter now, Siegel said, “We’re working on that.”

1993: Rahm is the architect of NAFTA

1994: Unions stay home after NAFTA. Democratic turnout poor, Democrats give up 54 seats in House.

2005: Rahm as head of DCCC recruits pro-war Dems, threatens to cut funds for any Dem who runs opposing the war

2006: Ned Lamont beats Joe Lieberman by opposing the war, opens the floodgates for candidates to buck Rahm & fuel Democratic takeover of House. Rahm’s pro-war candidates lose.

2007: Rahm blames failure of his pet pro-war candidates on immigration. Makes Freshmen co-sponsor anti-immigrant SAVE act.

2007: SAVE Act triggers Hispanic Caucus revolt on the floor of the House

2007: Rahm demands Democratic candidates inoculate themselves against expected GOP attacks by moving to the right on immigration.” Says Hispanics “don’t vote, ignore ‘em.”

2008: Hispanics provide Obama’s margin of victory in Florida, Nevada, New Mexico and Colorado.

2009: Rahm Emanuel pushing “triggers” to kill President’s campaign promise of a public option in January

2009: Creigh Deeds reinacts Little Bighorn in Virgina after saying he’ll “opt-out” of public option and Democrats stay home

2009: Bill Owens endorses public option, pulls off surprising upset in district with GOP advantage

2009: John Garamendi defies beltway conventional wisdom that Democrat in CA-10 had to be conservative like Ellen Tausher to hold the seat, says he’ll vote against any bill that doesn’t have a public option (or has triggers), scores decisive win

2009: On behalf of banks, Rahm helps Democrats water down post-Enron investor protections in Sarbanes-Oxley

2009: Jon Corzine loses in the wake of “growing anti-Goldman ” sentiment.”

2009: The day after the election, Senate Dems still pushing triggers.



Rahm doesn’t think about Democratic turnout. His reputation for “winning a Democratic majority” rests on his ability as a self-promoter to take credit for victories that happened in spite of him. The truth is that his “act more like Republicans” strategy just hasn’t worked out, and we’re getting whiffs of the disaster it spells for Democrats who follow it.

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The Italian counterterrorism prosecutor Armando Spataro is seeking 13-year jail terms for Jeff Castelli, a former C.I.A. station chief in Rome, and Nicolò Pollari, a former head of Italian military intelligence, for their suspected roles in the abduction. He is seeking 12-year terms for Robert Seldon Lady, who as C.I.A. station chief in Milan is accused of having coordinated the operation, and Sabrina De Souza, who worked in the United States Embassy in Rome and is accused of having worked closely with Mr. Lady.

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At the time of his abduction, Mr. Nasr was under surveillance by the Italian authorities, who suspected him of delivering sermons preaching violence from his Milan mosque and recruiting militants to send to Iraq in anticipation of the American invasion. He disappeared for a year after his abduction, finally resurfacing in Egypt, where he called his wife in Italy to say he had been tortured.

The phone call was enough to activate Italian prosecutors, who are required to investigate if there is the possibility a of a crime.

Prosecutors were able to reconstruct his disappearance using cellphone records traced to the American agents. The operatives used false names but left a significant paper trail of unencrypted cellphone records and credit card bills at luxury hotels in Milan, suggesting they believed they were operating with latitude.

All of the Americans are being tried in absentia and are considered fugitives. Court-appointed lawyers for several of the American defendants claim that prosecutors never adequately established their clients’ identities.

The C.I.A. has declined to comment, and the Italian government has denied involvement.

In June, Il Giornale, a newspaper owned by a brother of Prime Minister Silvio Berlusconi and widely seen as close to the Italian government, published an interview it said it had conducted via Skype with Mr. Lady, who has since retired and whose whereabouts are unknown. In the interview, he said of Abu Omar’s abduction, “Of course it was an illegal operation. But that’s our job. We’re at war against terrorism.”

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The Republican’s have just released their “alternative” bill to the Democrats’ health care reform legislation. It is frankly a meaningless, very long press release, filled with some really bad ideas. The Republicans did find basically only one section of the Democrats’ reform bill they really liked. In fact, the Republicans thought it was such a great idea that they added it, completely unchanged, to to their alternative bill.

What was the section? It was the Eshoo amendment on the pathway for biosimilars! They took this one division of the Democratic bill, and added it word for word to their own (Republican bill starting page 185 and Eshoo Amendment). I guess the only thing truly bipartisan in Washington these days is shilling for powerful industry lobbyists. It seems the one things Democrats and Republicans can agree on in health care is that lifesaving medication should be given a nearly endless monopoly period, so they are priced out of reach for many Americans in need.

The first thing you need to know about Goldman Sachs is that it's everywhere. The world's most powerful investment bank is a great vampire squid wrapped around the face of humanity, relentlessly jamming its blood funnel into anything that smells like money. In fact, the history of the recent financial crisis, which doubles as a history of the rapid decline and fall of the suddenly swindled-dry American empire, reads like a Who's Who of Goldman Sachs graduates.

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Precise details of the deal couldn't be learned. Some on Wall Street think Goldman could buy $1 billion of the tax credits, which would allow the bank to offset a portion of its profit. It is unclear how much of a discount Goldman is offering to pay. One person familiar with the potential transaction said Goldman could line up other investors for the deal as well.

Nearly every major business decision at Fannie Mae and Freddie Mac is vetted or directed by the government. Officials at both firms have complained about their contradictory missions -- they are at once private companies and tools of public policy.

The Goldman talks are emblematic of these conflicts: A deal that could help Fannie Mae might also be politically unpalatable.

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The Treasury Department has purchased $45.9 billion in preferred stock in Fannie Mae since it took over the company last year to pump money into the firm, giving taxpayers a substantial stake in the firm.

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A key issue will be how much of a discount Goldman plans to pay for the tax credits, especially if the terms are seen as generous to the bank.

Washington officials are likely to look at the deal with a skeptical eye. One reason: Approving it could further the perception that policy makers have taken steps in the last year that aided Goldman above other banks. For many in Washington still in the grip of populist fervor, Goldman has become a symbol of how Wall Street's recovery has outpaced that of Main Street, at taxpayer expense.

The Federal Reserve waived normal rules to allow Goldman and Morgan Stanley to quickly become bank holding companies last year, protecting them from some of the financial-market trauma that befell Bear Stearns and Lehman Brothers. The government injected $10 billion into Goldman through the Troubled Asset Relief Program. The bank was also helped by the bailout of American International Group Inc., through contracts Goldman had with the giant insurer.

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"As we see American workers' dreams of retirement being delayed and postponed and vanquished, and we see them losing their homes, as we see them losing their small businesses, we see record profits over at Goldman Sachs," Rep. Luis Gutierrez (D., Ill.) told Treasury Secretary Timothy Geithner at a congressional hearing Thursday.

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In her response to my article on her biologics bill, Anna Eshoo vehemently claims it doesn’t allow “evergreening,” which would allow slight tweaks in drug formulas to grant drug companies endless monopolies and keep these lifesaving drugs from ever becoming generics:



That’s news to Henry Waxman. Here he is on July 31, 2009 at the Energy and Commerce markup, on Anna Eshoo’s biosimilar amendment to H.R.3200:



The experts agree with Waxman. Glad to see Eshoo is committed to opposing evergreening, however. She better get to changing her language before her amendment passes the House.

From: The AffordableMedsNow Campaign of Universities Allied for Essential Medicines (UAEM) and the American Medical Student Association (AMSA) http://affordablemedsnow.com / and Essential Action’s Access to Medicines Project www.essentialaction.org/access

Re: Responding the October 30, 2009 Huffington Post article by Rep. Anna Eshoo, “Setting the Record Straight on Our Health Care Legislation”

Date: November 1, 2009


Below are some of the key assertions made by Rep. Eshoo in her recent blog post, followed by our responses to them.

Eshoo: Biotechnology products cost billions of dollars to develop, test and bring to market, and in order to ensure that competitors aren’t immediately allowed to free-ride on the costly safety and efficacy data produced by innovators, some period of ‘data exclusivity’ is necessary to allow some period of time to recoup the investment in developing the drug.

The House and Senate health care bills include a data exclusivity period of 12 years, which is the same amount of time that all drugs enjoy on the market under patent protection, which prevents any competition. I believe the 12-year data exclusivity period preserves the existing incentives for investment in these life-saving products.”

And

Without such a ‘data exclusivity’ period, there would be no reason to invest in new biologics. We would see the flow of research funds going to traditional pharmaceuticals, medical devices, semiconductors, green technology or other more promising innovations.

Response: The brand-name pharmaceutical industry’s own numbers show that research and development costs for biologics and conventional drugs are comparable, and that about the same amount of time is required. Eshoo’s approach would grant 12-years of market exclusivity to brand-name biologics — an extra 7 years of monopoly protection — more than double the five years conventional drugs receive. Moreover, the evergreening loopholes in the Eshoo-Barton approach adopted in the House health committee (which is identical to the Senate health committee’s adopted approach championed by Sens. Hatch, Enzi and Hagan) could make monopoly protection for many products indefinite. This approach doesn’t make sense given the numbers.


Sources for the above:

.....cont'd

Eshoo: It’s important to note that today there is absolutely no restriction on data exclusivity — it’s effectively infinite. Competitors are never permitted to use the data produced by a brand-name biologic manufacturer. The Kennedy-Eshoo legislation brings this exclusivity down from forever to 12 years, in essence laying the groundwork for the creation of the biosimilar industry, new competition for the biotechnology industry, and reduced prices for patients.

Response: It is true that there is currently no pathway to make generic biologics. However, we need a pathway that will work, not one that will introduce so many barriers that the pathway will seldom be used.

Eshoo: Let me individually address the patently false statements in Ms. Hamsher’s post.

“…thanks to Representatives Anna Eshoo and Joe Barton, there will be no generic versions of these drugs. At least not for 12 years…”

The 12-year data exclusivity period in the Kennedy-Eshoo legislation begins from the time of FDA approval. Since the vast majority of the most popular biologics treatments were approved at least 12 years ago, this means that they would have virtually no data exclusivity protection. The important cancer and anemia treatments that millions of patients rely on will be subject to biosimilar competition as quickly as the FDA can process the follow-on manufacturers’ applications. (For example, under my amendment Herceptin’s data exclusivity period will expire in September 2010.)

Response: It is true that for older biologics there is the potential for biosimilars to start coming on the market shortly after an FDA approval pathway is adopted. However, under Rep. Eshoo’s proposal it will be possible for brand companies to make relatively simple and inexpensive tweaks to the older biologics, and obtain a new 12-year protection period for the modified product. Then, based on the experience with conventional drugs, there is very strong reason to believe that brand-name companies will be able to exert their marketing acumen to transition patients (and doctors) to the modified product, and away from cheaper, generic versions of the old product. Indeed, it is quite likely that in many or most cases this prospect will deter generic manufacturers from entering the biogenerics market at all. This practice is called evergreening.

A classic example of how the evergreening process works involves the acid-reflux drugs Prilosec and Nexium. With its best-selling Prilosec facing generic competition, AstraZeneca introduced Nexium, a slight chemical variant of Prilosec. AstraZeneca studies showed the new drug to have the slightest improved performance from Prilosec, not for heartburn, but for “erosive esophagitis,” where burped-up stomach acid injures the esophagus. That slightly improved result enabled the company to launch a full-court press to get consumers to switch from the drug going off patent to the one just coming on. Nexium sells for about 5 times the price of Prilosec. Annual revenues for Nexium, on a global basis, top $5 billion.<1>

Troublingly, under Eshoo-Barton and Senate health committee approaches, evergreening will be easier and more effective for biologics than it is for conventional drugs.

First, in many or most cases, generic versions of biologics will not be identical with the brand-name product. In these cases, the generic product will be treated as “biosimilar” and not “interchangeable,” and will only be available to a patient upon specific prescription by a doctor. There will thus be a built-in bias in the system against switching to generic products — and make it easier for the brand-name company to direct patients to their modified, monopoly-protected products.

Secondly, conventional drug evergreening involves efforts to obtain new patent protection. Patent protection is much less robust than data exclusivity; this is especially true for patents on modifications to products. Generic firms are commonly able to challenge successfully or work around modification patents. By contrast, while the bar for attaining data exclusivity is lower than obtaining patent protection (which requires a new, useful and non-obvious invention), the data monopoly is absolute: it is granted automatically upon FDA marketing approval and is not subject to workarounds.

Moreover, with biologics expected to make up half of all the newly approved drugs in just a few years, we have to be concerned about accessibility to newer and better treatments that will continue to come on the market. Rep. Eshoo’s proposal will give these as yet undeveloped products an unjustified 12-year marketing monopoly, and, more troublingly, the evergreening loophole will also be available to them.

This means that the Eshoo-Barton and Senate health committee approaches will offer only the illusion of urgently needed price-lowering generic competition for biologics. These approaches will torpedo the objective of healthcare cost containment so crucial to current healthcare reform efforts, and severely limit patient access to these important and exceptionally high-priced medicines for conditions like cancer, arthritis and diabetes.

This means Medicare and other federal programs will find their budgets increasingly strained by growing biologic drug costs. Employers will continue to struggle to provide affordable health insurance to their employees. Americans with insurance will find it even more difficult to pay for their already sky-high prescription drug co-payments. And the uninsured may have to go without crucial lifesaving biologics

Eshoo: “And because of an ‘evergreening’ clause that grants drug companies a continued monopoly if they make slight changes to the drug (like creating a once-a-day dose where the original product was three times per day), they will never become generics.”

“There is no ‘evergreening’ clause in my legislation. There is in fact an ‘anti-evergreening’ clause which explicitly provides no new exclusivity period would be granted for “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.” My amendment prohibits by its plain language exactly what Ms. Hamsher alleges it would encourage.”

Response: The short answer is that the language highlighted by Rep. Eshoo does exactly the opposite of what she says it does: it preserves an evergreening option so long as there is a structural modification made to the biologic, which in the bill is an easy standard to meet. By contrast, Rep. Waxman and Sen. Schumer’s bills show what you’d do if you were trying to avoid evergreening.

The longer rebuttal follows: The clause Representative Eshoo refers to does appear on its face to exclude changes that result in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength from being eligible for a new 12-year exclusivity period. Unfortunately, her understanding of how the language operates is incorrect. The existence of the language in the bracket “(not including a modification to the structure of the biological product)”—actually does create a huge evergreening loophole. If you look closely at the tricky language of the sentence you will see that changes to biologics that result in new indications, routes, dosing schedules, delivery systems, strengths, etc., are ineligible for another 12- year exclusivity period under the Eshoo approach only if they come about without a modification to the structure of the product.

In other words, if a company makes a modification to the structure of the already approved biologic that results in a new indication or any of the other items listed, they will be eligible for a brand new 12-year exclusivity period. Unfortunately, because the term “structural modifications” is not defined, interpretation is open to a very wide range of possible changes that will qualify for a brand new 12-year monopoly, many of which are relatively simple and inexpensive to do, and which do not change a drug in any material way.

Of course, these modifications may offer small or significant patient benefits. But because they are typically easy and inexpensive to design, brand-name firms do not need the lure of protracted monopolies to make these minor modifications.

A key example of the types of modifications that would qualify for a new 12-year monopoly under the Eshoo approach is a process called PEGylaton, which will result in increased safety or a new dosing schedule, route, form, or delivery system. PEGylating a protein is a relatively inexpensive and easily performed structural modification (compared to changing the underlying amino acid structure of the biologic).

Example: Oncaspar is a PEGylated from of L-asparaginase used for the treatment of acute lymphoblastic leukemia. It is used in patients who are hypersensitive to the un-PEGylated form of L-aparaginase. The PEGylated product Oncaspar is now is being encouraged by the company for first line use instead of the older, un-PEGylated versions.<2>

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.

For your convenience, I have reproduced below the language of the relevant provision from the Eshoo-Barton-Inslee Biologics Amendment adopted by the House Energy & Commerce Committee in their healthcare reform bill in July 2009 in its entirety. (Note that this amendment is identical to that which was adopted by the Senate Health Education Labor and Pensions committee as part of its healthcare reform bill in July 2009)

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.”

Translation: Subsequent applications filed by the same sponsor or manufacturer are eligible for 12 years market exclusivity and filing moratorium for products that have a structural modification that results in either:

II) A new indication, route, dosing schedule, form, delivery system, delivery device, or strength; or

II) Improved safety, purity, or potency.

Only if the changes that result in the items listed in point I or II are not accompanied by a change to the structural modification are they ineligible for the 12-year exclusivity period. As explained above, it will be very easy for brand companies to make simple and inexpensive structural modifications to many biologics that result in new dosage forms, strength, etc. Thus Eshoo’s understanding of her own amendment’s language is incorrect.

Eshoo: I’m proud to have this legislation endorsed by: The AIDS Institute, ALS Association, Alliance for Aging Research, American Autoimmune Related Diseases Association, Association of American Universities, Candlelighters Childhood Cancer Foundation, former Vermont Governor Howard Dean, M.D., Immune Deficiency Foundation, the National Alliance on Mental Illness and many other patient advocacy groups.

Response: The vast majority of non-industry affiliated consumer, health and patient groups who have weighed in on this issue, plus a huge number of businesses, HMO’s and unions support the approach of Representatives Waxman and Deal and Senators Schumer, Brown, Collins et al, and oppose the approach of Representatives Eshoo, Barton and Inslee and Senators Hatch, Enzi and Hagan. A long list of consumer, health, patient and industry groups supporting the Waxman-Schumer approach and concerned about the Eshoo-Barton and Enzi-Hatch-Hagan approach (along with links to a few specific pieces of correspondence and key WebPages) can be found below. This list may be incomplete.

It also is worth noting that Eshoo-Hatch approach supporter Dr. Howard Dean has recently worked for BIO (the Biotechnology Industry Association), that the universities represented by the Association of American Universities stand to reap larger royalty payments from the patents they hold on biologic medicines for longer monopoly periods, and that the National Alliance on Mental Illness receives three-quarters of its operating budget from brand-name drug makers, according to a recent New York Times article, available at http://www.nytimes.com/2009/10/22/health/2...

If you do some research, you will likely find that many if not all of the patient groups that back Rep. Eshoo’s approach have significant ties to the brand-name industry, as this is a common practice of Pharma to fund patient and health groups. Very few (probably only two, but possibly a couple more) of the consumer, health and patient groups that oppose Eshoo’s approach take money from the either the brand-name or the generic biopharmaceutical industry. You could search the database created by Essential Action at http://www.pharmafiles.net / to see if any of the other patient and health groups Rep. Eshoo (or this memo) mentions as supporters have industry connections. FYI, the absence of a mention doesn’t mean that the groups don’t have industry ties: the database is a work in progress and there are literally thousands of pharma-funded patient and health groups.

.....cont'd

.....

"The mission in Afghanistan has been long and difficult and costly, but I believe it is necessary for stability and peace," he told a leadership conference in New Delhi. "If the Taliban and al-Qaida and their extremist allies were allowed to take over Afghanistan again, they would have a safe haven and the Afghan people, particularly the Afghan women, would face a return to a brutal tyranny.

.....

The best kept secret of the Bush's war crimes is that thousands of children have been imprisoned, tortured, and otherwise denied rights under the Geneva Conventions and related international agreements. Yet both Congress and the media have strangely failed to identify the very existence of child prisoners as a war crime. In the Islamic world, however, there is no such silence. Indeed, the prophet Mohammed was the first to counsel warriors not to harm innocent children. From jailing children together with adults in prisons where they were raped to failing to notify their parents of their arrest, the U.S. committed numerous war crimes against children in Afghanistan and Iraq, a new book on President Bush states. "American guards videotaped Iraqi male prisoners raping young boys but took no action to stop the offenses (and) children in Abu Ghraib were deliberately frightened by dogs," writes political scientist Michael Haas in his new book, "George W. Bush, War Criminal?"(Praeger), a question he answers in the affirmative.

.....

The World Prout Assembly is a non-profit organization affiliated with Proutist Universal Global Headquarters, Kolkata, India.

President Obama's health reform plan is in trouble. Public support for it is only lukewarm; both Left and Right oppose it. Pundits and editorial writers complain that Obama has turned the issue over to Congress, or that he hasn't explained the plan well enough. He and his staff have been working closely with many members of Congress from the very beginning, and he has described his plan repeatedly and in many forums -- and no one questions that he is a superb communicator. And yet disquiet and confusion persist. What has gone wrong?

.....

When Obama decided to tackle health care reform, he could have chosen to build it upon either the public or the private systems. He said he wanted to build on what works, and he could have proposed expanding the public programs we now have to cover everyone (or everyone who wanted that kind of coverage). These programs work, and they work well. Instead, he chose to base his program on for-profit private insurance, the part of our health financing system that is most expensive and deficient. He chose the private path, and, as Robert Frost said, that has made all the difference. No plan that rests on multiple weakly regulated for-profit insurance companies can possibly achieve the goals he has set out and still claims his plan will achieve.

.....

In an op-ed published in the New York Times on August 16, the president claimed that "if you don't have health insurance, you will have a choice of high-quality, affordable coverage for yourself and your family." However, as put forward in slightly differing versions by five congressional committees, nothing in his plan guarantees that the insurance offered by these private companies will be either "high-quality" or "affordable."

Currently, the average premium paid by employers for a family policy is $13,375; by 2013, when this plan would go into effect, insurance is sure to be even more costly. Insurance plans will have to meet new requirements, including no exclusions for pre-existing medical conditions, no co-pays for preventive care, annual limits on cost-sharing (co-pays and deductibles) of $5,000 for individuals and $10,000 for families, and no limits on lifetime coverage. All of these requirements, while desirable, will make insurance policies even more expensive. What many are beginning to realize, and to find objectionable, is that the plan does not regulate premiums, deductibles, or co-pays, so we will be required to buy insurance from companies that can charge us whatever they choose.

Employment-based insurance will be otherwise unchanged. Employers will still be able to change the coverage and the plan they offer their employees. Insurers can still change their provider networks, dropping or adding physicians and hospitals. Employees are still locked into their jobs if they want to keep their current plan. But now, employees must accept their employer's plan; the individual mandate requires it.

But won't the vaunted "public option" address some of these problems? The original "robust" plan would have provided real competition to the private insurers. It would have had open enrollment -- anyone could have joined. Like Medicare, it would have been backed by the federal government, and, according to the best estimates, nearly 120 million people would have joined it. Such a large public program could have had an enormous impact in reducing costs and leading to an efficient restructuring of health care delivery.

However, what even the most progressive committees in Congress are proposing is something very different. Enrollment in this public plan will be restricted to the uninsured and the smallest employers. The plan must be self-sustaining, following the same rules as private insurers and receiving no federal subsidy. And, as the president himself has said, the best estimate is that barely 5 percent of the American people will join it. The 800-pound gorilla has been turned into a mouse!

.....

In his New York Times op-ed, Obama went on to claim that "reform will finally bring skyrocketing health care costs under control." But nothing in the plan directly cuts costs. In fact, this plan will increase the overall cost of the health care system by hundreds of billions of dollars as millions of Americans who now have no insurance purchase policies from the insurance companies. The director of the Congressional Budget Office has said, "We do not see the sort of fundamental changes that would be necessary to reduce federal health spending by a significant amount." Instead, the plan relies on reducing waste and inefficiency in Medicare and Medicaid, on competition among insurance companies, and on a series of innovations -- computerization, chronic disease management, and new ways of providing and paying for medical services such as the "medical home" -- that are certain to cost added billions for the next few years and may, or may not, eventually produce some savings.

Then how will the plan be paid for? In his September 9 speech to Congress, Obama said "most of this plan can be paid for by finding savings within the existing health care system." Taxes on "Cadillac" health insurance, reductions in planned Medicare and Medicaid reimbursements to hospitals and other providers; cuts in subsidies to Medicare Advantage plans (the private plans that provide insurance to Medicare recipients); and reduced waste and fraud in Medicare and Medicaid are counted on to yield the necessary funds.

Congress is envisioning devoting nearly $1 trillion to this program over ten years. Unfortunately, even this substantial sum is not nearly enough to enable everyone to buy insurance under this plan. According to the Congressional Budget Office, between 17 million and 25 million people will need "hardship waivers" and will remain uninsured. So the designers of this plan have failed to achieve even their most basic goal.

.....

The alternative that Obama might have chosen is the public route to real health care reform, using Rep. John Conyers' Expanded and Improved Medicare for All Act, HR 676. This plan is straightforward. It would expand the existing Medicare program so that everyone would be covered via automatic enrollment, just as seniors are automatically covered now when they turn 65. It would provide comprehensive benefits, much improved over the existing Medicare program, which has deductibles and co-pays that keep many seniors from getting the care they need. It would allow free choice of doctor and hospital, which would remain independent, as they are now. A public agency would process and pay the bills, and the system would be financed through a progressive tax.

Numerous studies conducted over the past several decades have shown that -- in sharp contrast to a plan that relies on private, for-profit insurance companies -- such a simplified, publicly funded system would cost no more than we are now spending. Estimates based on a number of studies performed over the last decade suggest that covering the uninsured and improving the coverage of the underinsured, including eliminating co-pays and deductibles, would cost about $250 billion each year. On the other hand, the reduction in the cost of insurance administration (Medicare averages 3 percent overhead, while insurance companies average 20 percent) -- along with savings in hospital and doctor billing costs, savings from bulk purchasing, and savings from the better coordination of care that a single funding source could achieve -- will yield even more than that in savings. The excess could be used to retrain those who are now processing insurance bills, so they could begin doing useful work.

A Medicare for All program could be paid for in many ways. The simplest would be through a payroll tax in which, for instance, employees would pay between 4 percent and 5 percent of their paycheck while employers would pay between 8 percent and 10 percent. For both employers and employees, this would be a significant saving compared to what they're paying now.

Further, a Medicare for All program, unlike the congressional plans now on the table, offers real tools for containing costs in the future. These include the use of annual budgets, especially for hospitals; the planning of capital investment; and an emphasis on primary care, coordination of care, and more cost-efficient ways of paying for physician services.

Private health insurance is a defective product that needs an expensive fix. By building his program on private insurance, President Obama has tied himself to a system that is too expensive and is unlikely to achieve the goals he has set. It will not lead to universal coverage and cannot contain costs going into the future.

On the other hand, an expanded Medicare for All system can provide comprehensive services while costing no more than we now spend, and it provides real mechanisms for containing costs. Should a private mandate plan be passed, the problems of the health care system will not go away. Real health care reform will continue to be essential. As costs continue to climb faster than incomes, health care will absorb a larger and larger fraction of our national livelihood. At some point, we will have to move to a unified public mechanism for funding health care that will be truly sustainable.