Why Democrats Should Start to Sweat
By Daniel Henninger
October 29, 2009


If you're an elected Democrat anywhere to the right of Barney Frank, and trying to defend a competitive seat next November, you've got to be starting to sweat.

You wake up in the morning and just like every other morning as far as the eye can see the only thing in the news is the president's health-care reform. It's starting to look like Harry Reid and Nancy Pelosi are leading the Donner Party, the snowbound emigrants who bogged down in the Sierra Nevada winter in the 1840s and resorted to cannibalism to survive.

The betting is that with raw political muscle and procedural magic, the Congressional Democrats will pass something, call it reform and hand Barack Obama a “victory.” Maybe, but I think what we are seeing with this massive legislation is that the Democrats in Washington have a bigger problem: Their party is looking so yesterday.

In a world defined by nearly 100,000 iPhone apps, a world of seemingly limitless, self-defined choice, the Democrats are pushing the biggest, fattest, one-size-fits all legislation since 1965. And they brag this will complete the dream Franklin D. Roosevelt had in 1939.

The culture still believes the U.S. has a hipster for president. But the Obama health-care bill, and maybe this whole administration, is starting to look totally out of sync with the new zeitgeist, the spirit of the age.

Everything about the health-care exercise is looking very old hat, starting with the old guys working on it. Max Baucus, Patrick Leahy, Pete Stark-all were elected to Congress in the 1970s, and live on as the immortals in Washington's Forever Land. But it's more than the fact that Congress looks old. The health-care bill is big, complex, incomprehensible and coercive-all the things people hate nowadays.

It's easy to make jokes about how insubstantial the millions of people seem to be who are constantly using technologies like Twitter. But these new digital and Web-based technologies, which have decentralized virtually everything, now occupy most of the average person's waking hours at work or at home. Mass media is struggling to stay massive in a world whose people want to break up into many discrete markets.

The one lump that won't change is government. Government in our time is looking out of it. It'd be one thing if government were almost cool in an old-fashioned way, but it's not. When everyone else's job gets measured by performance, its hallmark is malperformance--whether in Congress, California or New York.

We define the past 25 years in terms of entrepreneurs and visionaries in places like Silicon Valley who took a small idea and ran with it. Congress does the opposite. It takes something already big . . . and makes it bigger.

We've got Medicare for the elderly, with spending claims out to Mars, so let's create Medicare for All! One of the least noticed parts of the health-care legislation is its intention to make Medicaid even bigger, when Medicaid's cost is arguably the main thing destroying California.

There was a time when contributing to the common good meant joining something relatively small like the Peace Corps or Teach for America. Now it means being willing to just fall into line behind some huge piece of legislation.

Read Mr. Obama's speech last week at MIT on climate change: "The folks who pretend that this is not an issue, they are being marginalized." This, ironically, sounds a lot like the 2007 antiHillary "Big Brother" TV commercial. Its message was that Hillary represented something big and ominously coercive. Boot up that ad now and put Obama's face where Hillary's is.

The larger point here isn't necessarily partisan. It's a description of the way people live their lives in a 21st century world, and how disconnected politics has become from that world.

If we were really living in the world of leading-edge politics that many people thought they were getting with Barack Obama, he would have proposed an iPhone for health care-a flexible system for which all sorts of users could create or choose health-care apps that suited their needs. Over time, with trial and error, a better system would emerge.

No chance of that. Our outdated political software can't recognize trial and error. What ObamaCare is doing with health care-the "public option"-may be fine with the activist left, but I suspect it's starting to strike many younger Americans as at odds with their lives, as not somewhere they want to go. Wait until EPA's ghost busters start enforcing cap-and-trade.

People thought something small, agile and smart was coming to government, but so far it's turning out to be just big-box politics.

None of this is to suggest the Republicans are any better. They do, however, have a better chance of breaking out of the ancient political castle. So long as the Democratic Party is the party of the Old Hat People, dependent on public-sector unions with Orwellian names like the Service Employees International Union, it will remain yoked to a pre-iPhone political model that will increasingly strike average everyday American voters as weird and alien to their world.

http://www.pnhp.org/news/2009/july/senate_help_amendmen.php

Consideration of the Enzi/Hatch/Hagan amendment on establishing a data exclusivity period of 12 years for biotech innovation

Sen. Orin Hatch: I don’t know a biotech company that isn’t for this bill, for this 12 year data exclusivity.

****

Sen. Kay Hagan: These individuals are out there looking for venture capital to obviously help them get these drugs to market… In order for our country to maintain this innovation and this research we need 12 years of data exclusivity.

****

Sen. Judd Gregg: Money flows into biologics research because capital moves there to make money. That’s the way a market system works.

****

Sen. Tom Harkin: Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is.

****

Sen. Bernie Sanders: Let’s find out why year after year the drug companies make hugh profits, look at why the drug companies have never once, to the best of my knowledge, have never lost a political debate here in Congress… (medicine) doesn’t do anybody any good if they can’t afford it. I think for year after year we’ve been paying a lot of attention to our friends in PhRMA, who are spending, I don’t know what they spend in lobbying and campaign contributions, a whole lot of money. Maybe it’s time that we start worrying about the people who have to pay for this medicine.

****

Sen. Sherrod Brown: You know what we’ve not talked about, Mr. Chairman? We’re not talking about how much these biologics are costing patients. Let me give you some numbers. (examples)… 48 thousand dollars… 20 thousand dollars …100 thousand dollars. You know what the average wage in my state is? 46 thousand dollars… If we do this giveaway to the drug industry, this giveaway to the biologic companies, it means profits are up for them, it means executive salaries are up for them, it means we can all feel good, but let’s think about the patients, let’s think of the patient with breast cancer who has got to spend 1000 dollars a week… the patient with colon cancer who’s got to spend 2000 dollars a week… What kind of progress is that, Mr. Chairman?

****

The data exclusivity amendment (to the health care bill) passed by a vote of 16 to 7, with several Democrats voting in support.

421 minute video of the July 13 afternoon session:
http://help.senate.gov/Hearings/2009_06_17...09_06_17_E.html

.

The Democrats who voted to support this outrageous amendment may be camouflaged to look superficially different from the Republicans you rail against but are essentially the same. What difference does party make here?

Background (Beamer's other thread): http://www.commongroundcommonsense.org/for...t&p=1030761

Oh come on G. Everyone has the right to criticize. We take them seriously or not depends on how we react to it.
<--Doesn't criticize as often since a lot of the times I don't see the point.

http://www.youtube.com/watch?v=5nhvAluve5k

IS THIS THE BEST WE CAN DO?
Congressman Dennis Kucinich

Posted on YouTube: October 29, 2009
Run time: 01:17

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http://www.democraticunderground.com/discu...;mesg_id=394649


MSNBC The Rachel Maddow Show - 26 Oct. 2009: 'HEALTH CARE FOR ALL*'

Big asterisk on Reid's Public Option - Full Segment w/ Interview with Sen. Ron Wyden.

Rachel explains with props today's developments in health care reform.

What we have ended up is 'Public Option.' Only for the Uninsured.' 'Only in Some Places.' No trigger.

MADDOW: "We begin, with what was a very big day today in Washington. Today, just a few days shy of November, the U.S. Senate took one giant step closer to where President Obama wanted it to be in August. In a highly anticipated afternoon press conference today, the top Democrat in the Senate, Harry Reid, announced what the Senate will be voting on, when it votes on health reform. Months of speculation about whether there will be a public option in the bill has now ended. There will be a public option."

SEN. REID (VIDEO): "I believe that a public option can achieve the goal of bringing meaningful reform to our broken system. It will protect consumers, keep insurers honest, and insure competition. And that's why we intend to include it in the bill that we have submitted to the Senate... I've concluded, with the support of the White House, Senators Dodd and Baucus, that the best way to move forward is to include a public option with the opt-out provision for states."

MADDOW: "So there you have it. The public option lives. But it's a public option with a big asterisk. A state that doesn't want the public option can opt out of the public option.

There's a pretty big range of options overall on the table for trying to fix our broken health system. At one far end of the spectrum, we could have ended up with a (holds up miniature British Union Jack) British-style nationalized health system. That's the government owning the health care system, employing doctors and providing coverage for every resident, man, woman and child. And that's what we have for veterans health care in this country, that's how the VA runs, and that's how England runs. If we can't get that, if we're too conservative a country to go for something like that for more than just our veterans... we could have also gone for the Canadian system (holds up Canadian national flag), which is essentially Medicare. The government doesn't employ doctors and nurses like they do in England, but it's a single-payer system, the government provides insurance for everyone. That's what Canada has. That's what Medicare is.

Another more conservative alternative to that is... there's not flag for that (holds up sign). It's the public option.

- snip -

But we also didn't get what they do in Britain, and the VA, or what they got in Canada... We also didn't get a public option that is available to everyone, or even a public option available only to uninsured people. What we got was a public option that's only available to uninsured people only in some places."

"(Weak 'Woo-hoo') Thank goodness we've got 60 Democrats in the Senate, right?"

"Of all the different things that Harry Reid could have put forward, of all the options that we had as a country, we've ended up, at least in the Senate proposal with a public option, but a really modest, conservative version of the public option. Maybe that means it will get 100 votes in the Senate? Yeah, right. Republicans will clearly all vote 'No' against this. Even Olympia Snowe said this is too much public option for her to stand."

- snip -

"One of the main arguments for the public option is that it would be big, and it would not only have the potential to give people another option at the consumer level, another choice of who you get your insurance from, it would also, because it would be big, have the potential to save the country a lot of money on health care..."

"If they only take up a really small part of the market, they're not going to have much bargaining power with the people who control how high health costs are. The smaller the number of people that are allowed to participate in the public option, the more you restrict who can get it based on things like where people live or whether or not they've already got some other form of insurance, the less likely it's going to be. The bigger it is, the more effective it's going to be at keeping costs down."

"So, politically, what's been created is an incentive, in which that conservative politicians can say at the state level 'The public option won't work.' And if enough of those conservative politicians can persuade their states to opt out of it, then that prediction that it won't work can become a self-fulfilling prophecy."

- snip -

"Joining us now is Sen. Ron Wyden of Oregon, who has been a consistent proponent of making the public option available to everyone. Senator, do you think that I was right with my props that that's sort of the descending cascade of conservative options that we had on health care reform?"

SEN. WYDEN: "Rachel, those were great signs, and the fact is that the public option will be a great tool, IF people can get it. Seems to me that Harry Reid deserves a lot of credit tonight. He's made it clear there ought to be options, but I continue to be concerned that, the way this proposal is written, more than 90 percent of Americans seven years after the bill becomes law, won't be able to hold insurance companies accountable... You can't get an accountable insurance industry with just a small fraction of the population. You've got to have the whole customer base of the industry on the line."

MADDOW: "... Do you think that what Sen. Reid is proposing could be amended to make it more effective, in your eyes."

SEN. WYDEN: "I think Sen. Reid has taken a strong step in the right direction. I do think when you ask the American people about this, you do a poll, for example, you never ask them if whether they support the idea of 10% of Americans getting the public option. You always ask whether all Americans should have it. I think the country supports that approach. That's what I'm going to fight for on the floor. The fact is that Americans all across the country use as a talking point that everybody should get this public option. Now we've got to get it in the bill."

MADDOW: "Let me ask you on the issue of talking points specifically, today Sen. Reid's office did put out a list of talking points on health care reform for Democratic Senators. And the last one caught my eye because I knew I was going to be talking to you, and it says:

'- Under our plan, if you like what yo have you can keep it, but if you don't there will affordable choices for you that can't be taken away.'

Is that really accurate, if such a small proportion of the American public is going to have access to the public option? ... Is that really true?"

SEN. WYDEN: Right now, reality is not in line with the rhetoric. Now, we have a lot of opportunities to turn this around. As I say, Sen. Reid has been a strong consumer advocate - he's advocating, for example, for McCarran Ferguson to take away the anti-trust break. But, yes, we've got to make sure that it's possible for Americans who hate their insurance company, who feel their insurance company is abusing them, to have choices like members of Congress. Members of Congress, if you get ripped off in the fall of 2009, you have plenty of choices, but under this bill, seven years after it is adopted, 90 percent of Americans still won't have choice."

MADDOW: "It seems like the potential for passing something that is robust and ambitious in health reform increases ... as you get closer to a 50-vote margin for what you need for passing something. In other words, if the Republicans are able to filibuster this bill, set a 60-vote threshold for what it takes to pass something, our options as a country are much more limited, in terms of what we can get out of health reform. The only way Republicans can filibuster is if A Democrat sides with them. Do you think that a Democrat will side with Republicans...?

SEN. WYDEN: I think that if progressives stay at this, continue at the grassroots level to make the case that all Americans should have choice, all Americans ought to be able to hold insurance companies accountable, I think we will have sixty votes in the United States Senate for a strong bill. But obviously, this is the key time, Rachel. You asked, for example, about making sure that all Americans had choices not just talking points. If folks at the grassroots level, the folks who are carrying those signs about the public option now say 'Look, it's not good enough that only ten percent of the population can hold insurance companies accountable. It's not good enough, at a crucial time in American history, to have choice available only to a handful of people who are poor and sick and unemployed.'

That's almost like a health-care ghetto.

Let's hold insurance companies accountable the right way, by making them put their whole customer base on the line."

.

http://www.huffingtonpost.com/rep-anna-esh...g_b_340106.html

Rebuttal by Anna Eschoo (and rebuttal to her comments by HuffPost posters)
Comments:
HuffPost's Pick
by sstrumello
The cost of development does NOT justify a longer duration of exclusivity. Even if development costs are higher than traditional small-molecule drugs, the return more than justifies it. The June 2009 GAO report concluded that NO exclusivity period was needed for biotech meds. Biotech meds will also remain protected by patents, which in many cases is far longer than the exclusivity period in your bill, making it a moot point. Because biologics do not require appreciably more time or money to bring to market than small-molecule drugs, it's reasonable to ask why they deserve longer protection from competition than 5 years? That exclusivity has done nothing to stop investment in new drugs. You also ignore the fact biotech meds sell for significantly more than small-molecule drugs do. According to Dr. Steve Miller, Express Scripts' CMO "The average cost of a biotech drug can be 10, 15 or 20 times higher than the average cost of a traditional drug." You and former Senator Kennedy are merely "bringing home the bacon" to your respective districts, but doing little to address the rapidly-growing cost of healthcare. Your bill only allows studies to be waived under certain circumstances, a decision better left up to the FDA. Furthermore, how can you claim that there is no 'evergreening' clause in your legislation? Your bill grants another 2 years for "medically significant" innovations; though the definition is deliberately vague and inapplicable to biotechnology. Rep. Waxman's bill was superior.

by 2Truthy
Thank you for this clarification, Ms. Eshoo. As a local constituent in your district, it would also be helpful to clarify whether these drugs (generic or not) which are subsidized by US taxpayers and developed offshore will be manufactured in the same Chinese melamine-tainted plants that make the Halloween candy, baby formula and pet food.

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http://www.boston.com/news/health/articles..._on_healthcare/
Biotech firms lobby for say on healthcare
$66m effort to protect drug-patent exclusivity

By Lisa Wangsness
The Boston Globe
July 21, 2009

The 46 million Americans without health insurance are probably not spending much time thinking about how Congress should curb monopolies on expensive biotech drugs. But the issue, which offers a case study in the ways of Washington influence, is among dozens that have spurred a lobbying frenzy this summer as Congress debates a historic healthcare overhaul.

Pharmaceutical interests alone, including many from Massachusetts, spent more than $66 million on lobbying in just the first quarter of this year, up 25 percent from last year, according to the nonpartisan Center for Responsive Politics.

Biotech firms produce the most expensive drugs on the market, charging $10,000 to $100,000 a year for a single patient, and generics would seriously undercut those prices. In their quest to win a 12-year exclusivity period for their drugs, free from such competition, biotech companies have launched a massive education campaign about what they say are the sky-high research and development costs involved with bringing them to market.

To help carry the message, they are paying well-connected lobbying firms, sponsoring radio ads as well as academic studies, and contributing to the campaign coffers of influential lawmakers.

“You get one crack at it,” said Robert Coughlin, president of the Massachusetts Biotechnology Council, speaking of the task of drawing up a licensing system for “biogenerics.” “If it isn’t done right, it could literally put the biotech industry out of business.”

The quest for influence is not always obvious.

Howard Dean, the former Democratic Party chairman, wrote an opinion piece this month in The Hill, an influential Capitol Hill newspaper, arguing that fewer than 12 years of monopoly rights for biotech companies’ products “would prematurely rob innovators of their intellectual property and . . . destroy incentives to develop new cures.”

Within hours Joe Trippi, a Democratic consultant who ran Dean’s 2004 presidential race, hyped Dean’s opinion piece in a blog post that he sent to The Huffington Post, a widely read website. “He’s a doctor and lifelong advocate for health reform - he knows what he’s talking about,” Trippi wrote, urging readers to contact their lawmakers.

Dean failed to note in his (original) editorial that he is an adviser to McKenna, Long & Aldridge, a global law firm that is advising the Biotechnology Industry Organization (BIO), the influential trade group. Nor did Trippi mention that his public relations firm handles social media projects in a partnership with the Boston public relations company Brodeur Partners, which also has BIO as a client.

Dean said his editorial was part of McKenna’s rapid-fire response to an unexpected, eleventh-hour Senate health committee proposal (which biotech firms ultimately fought off).

“It was a huge scramble, all hands on deck,” Dean said.

The legions of lobbyists, strategists, and legal consultants involved include former senior aides to key lawmakers and executives. Top biotech companies are clients of Foley Hoag, a law firm with offices in Boston and Washington, which has deployed Nick Littlefield, former staff director and chief counsel for Senator Edward M. Kennedy’s health committee, and Paul Kim, the former deputy health counsel to the Kennedy’s committee.

Biotech won a major battle last week when Kennedy’s Senate health committee gave biotech firms the 12-year protections they wanted, plus six months for pediatric versions. The committee rejected a proposal by Senator Sherrod Brown, Democrat of Ohio, for a much shorter monopoly period. After the vote, generics companies said they wouldn’t even bother trying to make generic biologics because the 12-year protection would make the enterprise unprofitable.

“The pharmaceutical industry, especially the biotech industry has an awful lot of power in the halls of Congress,” Brown told reporters.

State leaders from around the country, including Governor Deval Patrick, wrote letters to their delegations supporting a biotech-friendly bill. CEOs have flown to Washington to drive their points home. The Globe reported earlier this year that Amgen donated $1 million to the Edward M. Kennedy Institute for the United States Senate at the University of Massachusetts Boston, a project being developed by people close to the senator but not Kennedy.

In the health committee vote last week, a number of other left-leaning Democratic senators sided with the industry, including Patty Murray of Washington, Barbara Mikulski of Maryland, Jack Reed and Sheldon Whitehouse of Rhode Island, and Kay Hagan of North Carolina. Kennedy supported the measure by proxy.

Hagan, a freshman senator whose state is home to a biotech sector, was assigned to the health committee this winter. Few were surprised when she cosponsored the industry-friendly amendment. But biotech firms were not taking chances: In the first half of this year, they poured $16,000 into her campaign account. Hagan believes the protections are necessary to support research for new drugs.

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http://www.pnhp.org/news/2009/july/senate_help_amendmen.php

Comment on the 12-year data exclusivity amendment
By Don McCanne, MD

The vote on the data exclusivity amendment was covered in a qotd last week, at the link above. More background information is provided by Lisa Wangsness in her Boston Globe article. Because of the implications for the reform process unfolding in Washington, we are taking a second look.

Having a twenty year patent on a biological that can command a one hundred thousand dollar price tag is not enough for the biotech firms. They also want a 12 year lead time before competitors can begin to use the data, produced in our academic medical centers, for developing new innovative drugs or even generic equivalents. This doesn’t change the 20 year patent exclusivity, but it requires future competitors to wait 12 years before beginning their research that would be based on the existing data.

That slows future innovation and research. It slows the introduction of generics that can result in competitive pricing. It decreases the chance of breakthroughs that could replace a one hundred thousand dollar biologic with a two hundred dollar product that might be more effective and less toxic.

Watching the prolonged committee deliberations on the 12 year data exclusivity amendment, it was obvious that the arguments presented by the senators in support of this amendment had been written by the biotech lobbyists. It was also obvious that only a few of the senators had rejected the lobbyists’ overtures.

The Boston Globe article demonstrates that this was not about policy, but about process. It shows how the most powerful lobbyists can cast their nets and pull in the best of them.

Howard Dean was a part of the “all hands on deck” scramble to support the data exclusivity amendment. It was simply a job that he was expected to do as part of the McKenna rapid-fire response team.

It was particularly painful to watch Senator Dodd, acting chairman of the Senate HELP Committee, cast an aye vote by proxy on behalf of Sen. Ted Kennedy, even though Sen. Dodd had already cast a no vote on his own behalf. It would be unfair to speculate what may have caused Sen. Kennedy to communicate his wishes on that vote, but it is likely that Amgen feels that they paid a million dollars for that vote, fair and square.

Does anyone else agree that we need a fully transparent re-start on reform?

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http://thehill.com/special-reports/the-eco...o-health-reform

Legislation on innovative drugs is key to health reform
By Howard Dean - 07/08/09 08:08 AM ET

More than 60 years after President Harry Truman called on Congress to provide Americans the “opportunity to achieve and enjoy good health” and “protection or security against the economic effects of sickness,” we are still fighting for healthcare reform.

Since Truman’s time, the health landscape in this country has changed dramatically. Diseases such as polio and tuberculosis are no longer the scourges they were. Advancements in biomedical research have led to treatments that have helped people with cancer, cystic fibrosis and a host of other diseases. In the 1950s, the cure rate for cancers was 33 percent, whereas today nearly two-thirds of people diagnosed with cancer live five years or more after their diagnosis.

As we move toward a universal healthcare system, most of the debate centers on big-picture issues such as how to craft and finance a public health insurance option. There is much less focus on smaller, but equally essential issues. One of these is patent reform. Another is maintaining America’s leading edge in research and innovation.

The Congress is now developing a regulatory pathway for the approval of biosimilars — medicines that are similar to, but not the same as, breakthrough biologics. Some inaccurately suggest that biosimilars are essentially generic versions of traditional pharmaceutical drugs. Biologics are actually much more complex than traditional drugs and cannot be copied using existing science. By expanding market competition, biosimilars can expand access to and reduce the cost of these cutting-edge drugs. But if the initial breakthroughs are not supported by adequate patent protection, innovation in America will die. And given the complexity of biologics, a properly constructed biosimilars pathway must provide necessary protections to ensure patient safety.

A commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years. A shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures. Most firms would be unable to recoup their investments in new medicines, which ordinarily top $1 billion and involve 15 years of research and development. If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures.

These principles are incorporated in biosimilars legislation sponsored by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) in the House (H.R. 1548) and in The Biologics Price Competition and Innovation Act introduced by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) in the last Congress. Both bills include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments — and even cures — to patients around the world. To encourage market competition, this should be combined with provisions that allow the patent life to begin running at the time of FDA approval, not at the time of application. Frivolous lawsuits over patents also should be eliminated at the end of patent life.

Today, too many diseases and disorders remain with no treatment or treatment with limited therapeutic benefit. With the right balance, we can set a path for biosimilars that maintains the highest standards for patient safety, lowers costs and increases access today while providing the necessary incentives for new therapies and cures tomorrow.

Dean, M.D., is a former Vermont governor, Democratic National Committee chairman and presidential candidate.
(Update) He is a consultant to McKenna Long & Aldridge, which represents biotechnology companies.
This page was updated on July 17 at 1:51 p.m.
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http://www.google.com/search?q=howard+dean...amp;rlz=1I7DMUS
Dean Op-Ed discussions

http://drugwonks.com/account_blog/row?_met...get&id=6882
Dean of all Lobbyists?
July 20, 2009

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I work for a biotechnology company, and the monopoly rights on patents is essential in order to recoup the costs of developing these drugs.

Biotechnology companies employ people. They are a major industry in San Diego, as well as San Francisco, Boston, Raleigh-Durham, North Carolina and other areas of the country. Cities all over the country want biotechnology companies to locate in their areas because they bring clean industry and high-paying tech jobs. This is good for the economy.

I don't know what the solution is to the cost of developing drugs. The process is unbelievably cumbersome, long - and risky. Millions of dollars in development cost can result in a drug not even gaining FDA approval. Then, it's back to the drawing board for the biotech company. Many times, they have no other drugs in their pipeline, and their company may not even survive.

I read an article by Jane Hamsher about a breast cancer treatment that she felt should be made available for women despite its cost. Herceptin costs $47,000 a year! Who could afford that? In fact, no one can afford that except for extremely wealthy people or through insurance companies that spread the cost around. But if a lot of people are receiving expensive treatment, how can insurers cover them without raising premiums? If the government picks up the tab for these expensive drugs, then that is a cost all of us will bear. I don't know the answer, except to try our very best not to get get a serious illness.

I understand people's desire to have the government offer low-cost public insurance, but SOMEBODY subsidizes that - like the taxpayers. And these high costs for drugs and other treatments cannot be brought down through just covering more people.

REMEMBER THE POST ABOVE THIS ONE

Just like Evan Bayh's wife...

we got a tool for the big ones right here.

that's right TOOL TOOL TOOL TOOL TOOL TOOL TOOL TOOL


actually, the answer is simple
government run and as a not for profit
why is there even a hint of profit involved?

how pathetic

it's like d'uh so easy

like d'uh

That is the problem.
I haven't found a viable alternative.

beamer- you have NO right whatsoever to criticize

you are NOT a democrat, you are a conservative republican (though you deny it, your voting record shows it).

you have given us false info as to your beliefs in the past
(i.e.- you claim to be for the environment, yet you hate Al Gore, the #1 most for the environment of anyone, and I shudder to think your reaction to the
cap Gore wants if that passed).

you are very selfish, wanting to cuddle your cheapie GOV'T RUN INSURANCE THAT you have, but you don't want anyone else to get it

I call that GREEDY

VERY RONALD REAGAN (WHOM YOU VOTED FOR) YUPPIEISH.

Makes me wanna puke.


Obama won, and he already has won 2012. So get over it.

I still believe in doing something to encourage green living and investing in green technology to create jobs. So, I don't agree in total with what Henninger says. Plus, he's probably a neocon.

But I agree with him. The Democrats are acting like it's the 70s again. And, they're going to get stomped by an innovative-sounding conservative, as they did in 1980.

Independents who supported Obama do not want big government liberalism and they don't want big government militarism. A new party is needed.

http://www.pnhp.org/news/2009/july/senate_help_amendmen.php

Comment on the 12-year data exclusivity amendment
By Don McCanne, MD

The vote on the data exclusivity amendment was covered in a post last week at the link above. More background information is provided by Lisa Wangsness in her Boston Globe article. Because of the implications for the reform process unfolding in Washington, we are taking a second look.

Having a twenty year patent on a biological that can command a $100,000 annual price tag is not enough for the biotech firms.

They also want a 12 year lead time before competitors can begin to use the data, produced in our academic medical centers, for developing new innovative drugs or even generic equivalents.

This doesn’t change the 20 year patent exclusivity, but it requires future competitors to wait 12 years before beginning their research that would be based on the existing data.

That slows future innovation and research. It slows the introduction of generics that can result in competitive pricing. It decreases the chance of breakthroughs that could replace a one hundred thousand dollar biologic with a two hundred dollar product that might be more effective and less toxic.

Watching the prolonged committee deliberations on the 12 year data exclusivity amendment, it was obvious that the arguments presented by the senators in support of this amendment had been written by the biotech lobbyists. It was also obvious that only a few of the senators had rejected the lobbyists’ overtures.

The Boston Globe article demonstrates that this was not about policy, but about process. It shows how the most powerful lobbyists can cast their nets and pull in the best of them.

Howard Dean was a part of the “all hands on deck” scramble to support the data exclusivity amendment. It was simply a job that he was expected to do as part of the McKenna rapid-fire response team.

It was particularly painful to watch Senator Dodd, acting chairman of the Senate HELP Committee, cast an aye vote by proxy on behalf of Sen. Ted Kennedy, even though Sen. Dodd had already cast a no vote on his own behalf. It would be unfair to speculate what may have caused Sen. Kennedy to communicate his wishes on that vote, but it is likely that Amgen feels that they paid a million dollars for that vote, fair and square.

Does anyone else agree that we need a fully transparent re-start on reform?

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Sen. Tom Harkin: "Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is."




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