Senate Moves Towards Forced Vaccinations
Zeus Note: This legislation was passed just before Christmas. Below are a collection of related articles. Some of the links that no longer work have been taken out.
From: Emma Holister Emma's cartoons attached to this article Senate Moves Towards Forced Vaccinations, Vaccine Damage Immunity for Drug Companies Associated Press | December 2, 2005
By ANDREW BRIDGES RELATED:
CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES
By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.
The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from long-standing open records and meetings laws that apply to most government departments, according to legislation approved Oct. 18 by the Senate health committee.
Those exemptions would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill. The legislation also proposes giving manufacturers immunity from liability in exchange for their participation in the public-private effort.
"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Sen. Richard Burr, R-N.C., said when the Committee on Health, Education, Labor and Pensions approved the bill.
The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics as well as chemical, biological and radiological agents.
But it is the secrecy and immunity provisions of the legislation that have alarmed patient rights and open government advocates. The agency would be exempt from the Freedom of Information and Federal Advisory Committee acts, both considered crucial for monitoring government accountability.
"There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. "That is a cause for major concern and should raise major policy concerns," Weitzel said.
Burr spokesman Doug Heye said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential business information already is exempt from FOIA.
"There's no secrecy involved in BARDA," Heye said. "That is absolutely false. This is an agency that will be putting out information daily."
Some Democrats question whether the public would accept drugs or vaccines developed in conjunction with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line health care workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about the vaccine's safety, which health authorities initially downplayed.
"Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement. "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."
The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless "willful misconduct" can be shown.
The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill. Another industry group, the Biotechnology Industry Organization, declined comment.
The National Vaccine Information Center, an advocacy group, called the legislation "a drug company stockholder's dream and a consumer's worst nightmare."
The proposed law comes amid growing concern about pandemics and the government's ability to meet such threats. For instance, the United State needs another three to five years to develop the manufacturing capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday on NBC's "Meet the Press."
The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.
"While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said. "One of the reasons is (they) don't want to put their very existence on the line."
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the agency as proposed would represent a setback to decades of progress in opening up to the public the process of testing the safety and efficacy of drugs.
"These provisions are extremely dangerous," Wolfe said. "The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics, is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act to increase public scrutiny and increase the correctness of decisions that are made."
Republican and Democratic lawmakers alike agree the drug industry needs some protections to encourage it to produce emergency stocks of vaccines and drugs, but Democrats have balked at providing blanket immunity without first establishing a compensation fund for patients.
Republicans are pushing for liability protections for vaccine manufacturers on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking to add such protections to a defense appropriations bill.
Frist spokeswoman Amy Call said drug company concerns about liability are real.
"There's really no financial incentive for them to get into the market, sell to the government at a reduced rate and then open themselves up to losses that could potentially bankrupt them," Call said.
The push for liability exemptions may force the Burr bill to the sidelines until the next session of Congress, Republican and Democratic aides said. But Call said Frist intends to pursue the legislation.
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Thanks to Sheri Nakken, R.N., MA, Classical Homeopath, for sending the articles below:- http://www.nccn.net IMMUNITY FOR THE DRUG INDUSTRY 22/12/05 - Written by the Democratic Health, Education, Labor, and Pensions Staff, addressing scandalous language added in once again by Senator Frist, in a must pass DoD appropriations bill:
In the middle of the night, Republican leaders attached sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report. The language constitutes an unprecedented pharmaceutical industry wish-list of liability protections that go way beyond avian flu preparedness and that will allow the industry to injure or kill Americans with contaminated drugs and vaccines and never be held accountable. This language is broader than any House or Senate bill and has never been considered by any committee or passed by either body. The language in fact, even expressly immunizes pharmaceutical company recklessness.
The language:
Applies to a wide range of drugs, vaccines, and other products. The proposal provides that any "drug, biological product or device that is used to mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause." may be covered and given immunity. The proposal does not, in any way, limit its application only to new drugs or vaccines used in a pandemic context. The scope of the proposal is so broad that it could include drugs like Tylenol, Advil or Vioxx.
Allows the Secretary to declare an emergency under ANY circumstance. The immunity for drug companies is triggered upon a declaration by the Secretary of Health and Human Services (HHS). The language is so broad that it allows the Secretary to make a declaration at any time, for almost any reason, and for any period of time he or she so chooses. The Secretary may make a declaration pursuant to this section if a disease or health condition is a public health emergency or "there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency." [emphasis added.] There will always be a future risk of a health condition becoming an emergency, but that future risk alone should not be enough to justify total immunity for the pharmaceutical industry. This declaration is not subject to appeal, or to any independent judicial review.
Provides for total preemption of state law during the declaration. The language also preempts all state laws, requirements, or state tort law that is different from or in conflict with the federal rule.
Immunizes drug companies for reckless and grossly negligent conduct. The only exception to the grant of wholesale immunity is in the case of "willful misconduct." However, willful misconduct is defined as evidence that the drug company had actual knowledge that their product would injure or kill someone. This requirement means that only conduct that would also constitute assault, battery or murder would be sufficient to find "willful misconduct." The language explicitly protects recklessness by stating, "a standard for liability that is more stringent that a standard of negligence in any form or recklessness." That is language never before seen in any proposed bill.
Immunizes criminal conduct when the Secretary or the Attorney General fails to act. Even if a drug company has acted with "willful misconduct" as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.
Erects insurmountable barriers such that Americans will never be able to hold a drug company accountable. Under the language, a person who has been injured by a dangerous drug or vaccine must prove "by clear and convincing evidence willful misconduct" on the part of each and every defendant drug company. This standard of proof is so high, and rarely used in civil proceedings, that the injured individual will never be able to hold a drug company accountable.
Includes severe restrictions even if a claim is allowed. In the unlikely event that a claim is allowed to go forward because a court has found sufficient evidence that a drug company intentionally and willfully injured or killed a person, the following restrictions would still apply:
* The complaint must be accompanied by physician's affidavit by a doctor who did not treat the person that the person is suffering from an effect of the covered countermeasure;
* The injured individual must provide their medical records that show that the injury was caused by that countermeasure;
* An exclusive federal cause of action, barring individuals from filing a claim in their own state court under state law;
* The elimination of the collateral source rule such that any damage award received by the injured person would be reduced by any other payment received by the individual, such as health insurance or disability benefits;
Includes provisions of the so-called "Lawsuit Abuse Reduction Act" (LARA). Proponents have even dumped into this proposal provisions of LARA, a bill which has twice passed the House but has never been considered in the Senate. Among other things, the proposal would amend the Federal Rules of Civil Procedure without following the normal rule-making processes.
Establishes a "compensation" fund under the sole direction of the Secretary. The language establishes a fund similar to the smallpox compensation fund. However, the fund is operated under regulations established by the Secretary alone, includes caps on compensation, and is inoperable until Congress appropriates a sufficient amount of money for the fund to operate.
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"Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines against human papilloma virus, a sexually transmitted disease that is a major cause of cervical cancer, could be big sellers for Merck & Co. and Glaxo who are each developing one. "
http://www.thnt.com/apps/pbcs.dll/article?AID=/20051211/BUSINESS/512110337/1003
Drug makers seek protection
Home News Tribune Online 12/11/05
THERESA AGOVINO THE ASSOCIATED PRESS
NEW YORK - Large pharmaceutical companies are approaching development of vaccines and drugs for potential pandemics with trepidation, even as fears abound of a bird flu outbreak and doctors lament a shortage of treatment options.
Drug makers are especially afraid of lawsuits stemming from vaccines which, unlike drugs, are given to healthy people, making any harm they cause an even bigger legal risk.
Proposals in Congress would exempt companies that manufacture vaccines and drugs for pandemics from lawsuits. Senator Bill Frist, R-Tenn., is trying to put a rider on a spending bill that would immunize drug makers and another freestanding bill introduced by Senator Richard Burr, R-N.C., seeks to accomplish the same goal.
That's a necessary safeguard to promote interest in developing those medicines, drug makers say.
"We won't do it without indemnification," said Len Lavenda, a spokesman for Sanofi Pasteur, the vaccine arm of Sanofi-Aventis SA.
But some insist immunizing drug companies won't be enough to spark interest in a field fraught with an uncertain pricing structure. Unlike drugs for conditions such as cholesterol and high blood pressure, which have guaranteed markets, medicines for pandemics will only be used sporadically, if at all.
The government adds to the pricing pressure. The Centers for Disease Control and Prevention buys 55 percent of the recommended childhood vaccines and pays substantially less than the private sector, so some experts suspect payments for pandemic treatments will be less than generous.
When anthrax fears surfaced after the Sept. 11 attacks, the U.S. government threatened to break the patent covering Cipro, an antibiotic made by Bayer AG. And Roche Holding Ltd. has already been under tremendous pressure to lower the cost of its Tamiflu, which is believed to be effective against bird flu, and give others permission to make it.
"Companies are worried about low prices," said Frank Sloan, professor of health policy, law and management at Duke University.
"They are worried they won't recoup their research and development costs," he said. "That is the real problem."
In a statement, Senator Edward Kennedy, D-Mass., called the attempts to indemnify companies "a sweetheart deal for the drug industry."
A spokesman for Burr said his bill contains provisions to compensate people hurt from treatments through government funds and that companies will only be indemnified when the product is used in a pandemic, not for a general medical problem.
The drug industry insists such moves are crucial. In a pandemic, a vaccine may be approved without the same level of testing that would be normally required and given to virtually all Americans.
"This is 300 million plaintiffs you are talking about," said John Clerici, a lawyer who represents Sanofi and other companies. "If they get anything, they'll blame it on the vaccine."
Sheltering drug companies from lawsuits isn't without precedent. Acambis PLC was protected to make an Anthrax vaccine and the manufacturers of swine flu vaccines were given the same treatment back in the 1970s.
Individuals seriously harmed by vaccines the U.S. government recommends for children are paid through a federal pool funded by a tax on inoculations. But Lavenda said lawyers are seeking ways to collect damages from companies instead of the government fund.
Chris Viehbacher, president of GlaxoSmithKline PLC's U.S. pharmaceuticals business, estimates the industry has spent $200 million preparing itself for lawsuits over a vaccine preservative in children' s vaccines.
Lavenda said the issue of immunity from lawsuits must be cleared before other negotiations can begin on issues such as price.
Lobbyists and pharmaceutical executives said the main force pushing for indemnity is not the drug industry, but the Biotechnology Industry Organization, a trade group. BIO declined comment, but lobbyists and analysts suggested its members are far more interested in pandemic medicines than drug companies.
"Biotech companies are more amenable to working in new areas. They are startups," said Christopher Milne, assistant director at the Tufts Center for the Study of Drug Development. "Big pharmaceutical companies are resistant to getting heavily involved where the government is paying. They remember the Cipro incident."
Generex Biotechnology Corp. recently hired a lobbying firm to help it get government contracts to develop its bird flu vaccine.
Anna Gluskin, Generex's chairwoman, CEO and president, said she isn't worried about lawsuits because the company's vaccine is made from synthetic proteins, which she maintains is a safer manufacturing process.
Some pharmaceutical companies have chosen to develop a vaccine for bird flu. Sanofi Pasteur has a government contract to produce 8,000 doses of an experimental vaccine, but it has received indemnity from lawsuits. Glaxo said it will start a small trial in Europe during the first quarter of next year, and discussions with regulators haven't progressed enough to have included the indemnity issue.
Viehbacher said any company which successfully creates a vaccine would have leverage over the government. Vaccine production is complicated, so breaking a patent wouldn't guarantee supply, he said.
Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines against human papilloma virus, a sexually transmitted disease that is a major cause of cervical cancer, could be big sellers for Merck & Co. and Glaxo who are each developing one.
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U.S. Senators with up to $13.4 million in pharmaceutical holdings increased the value of their stock portfolios last night when they approved an amendment to the defense appropriations bill that immunizes drug makers from accountability to the public when they sell dangerous drugs and other products, according to the Foundation for Taxpayer and Consumer Rights (FTCR).
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http://www.whitehouse.gov/news/releases/2005/12/20051222-10.html
President Applauds Congress for Passing Defense Appropriations Bill I applaud the Congress for passing legislation to fund our troops who are fighting the war on terror in Iraq, Afghanistan, and elsewhere. This funding will help us continue to hunt down the terrorists, pursue our strategy for victory in Iraq, and make America more secure. I look forward to signing the bill into law.
What the president does not mention in the 'making of America more secure' - is that in the bill, Senator Frist slipped language into the bill indemnifying manufacturers from their products (drugs/vaccines, et. al) that can harm, disable and/or kill the American people. The arctic drilling was widely focussed on, and that amendment was pulled from the bill. The environment in Alaska is now safe - Americans in the US however, are now not. What the president also fails to mention is that he was the #1 recipient of contribution funds for the 2004 election, bringing in over $1,000,000.00 from PHARMA.
http://www.secretwebsites.com/say_no_to_drugs.htm - For those that believe I'm slamming Republicans, I am not - it just so happens those mainly responsible are Republicans - but, there are a few democrats as well.
Again, here are the 38 senators that voted this bill in, with a conflict of interest with ties to the pharmaceuticals (stock holdings):
Allen (R-Va.), Bayh (D-Ind.), Bingaman (D-N.M.), Bond (R-Mo.), Boxer (D-Calif.), Brownback (R-Kan.), Burns (R-Mont.), Carper (D-Del.), Coburn (R-Okla.), Cochran (R-Miss.), Conrad (D-N.D.), Crapo (R-Idaho), Dayton (D-Minn.), DeWine (R-Ohio), Dole (R-N.C.), Ensign (R-Nev.), Feinstein (D-Calif.), Frist (R-Tenn.), Hatch (R-Utah), Hutchison (R-Texas), Inhofe (R-Okla.), Isakson (R-Ga.), Kerry (D-Mass.), Kyl (R-Ariz.), Landrieu (D-La.), Lautenberg (D-N.J.), Levin (D-Mich.), Lieberman (D-Conn.), Lott (R-Miss.), Reed (D-R.I.), Reid (D-Nev.), Roberts (R-Kan.), Stevens (R-Alaska), Sununu (R-N.H.), Talent (R-Mo.), Vitter (R-La.), Voinovich (R-Ohio) and Warner (R-Va.).
If you notice that your state/senator is listed above, congratulations - you just noticed that your Senator just screwed you over (don't expect a dinner - and remember this on election day). If you think that PHARMA does not run this country, think again. PHARMA has just proven that they can buy and even own Congress and the President. With all the hype on "protecing america against the war on terrorism" - today, America has just been taken hostage by its own government.
Read the below statemement from Dem. David Obey (WI) - it is long, but, it is very much worth the read. There are few exceptions to those in power who I believe are trying to do the right thing for their constituents and America - this gentleman below is one of them.
House Committee On Appropriations, Democratic Staff David R. Obey (WI-07), Ranking Member For Immediate Release Contact: Kirstin Brost December 22, 2005
202-593-1310
Obey Statement on Defense Appropriations Correction Bill
A Shameful End to a Shameful Congress
WASHINGON -Dave Obey (D-WI), Ranking Member of the House Appropriations Committee, made the following statement this afternoon on the bill stripping the provision to allow drilling in the Arctic National Wildlife Refuge (ANWR) from the Defense Appropriations Conference report:
"Mr. Speaker, reserving the right to object: "More than a year ago, when Mr. Lewis was elected Chairman of the Appropriations Committee, he came to me and asked if we could have an understanding that we would express our substantive differences but still cooperate in moving bills forward in an orderly way once those differences had been expressed. We did that.
"Time and time again, the Minority was denied the opportunity to offer different sets of priorities, priorities that did not offer huge tax cuts for those who have the most in society, paid for with cuts in education, health care, and worker protection for those who have the least. Despite the fact that the rules of the House were used to block our efforts to obtain on-the-record votes on a number of our alternatives, Democrats continued to cooperate procedurally, even as we made clear our differences on policy.
"The Republican Majority wanted to finish all of these bills by the end of the fiscal year, and we did not procedurally obstruct them because while we differed strongly with the values that lie behind their budget priorities, we respected the fact that they are in the Majority and we respect and revere this institution. But because of internal divisions between the Majority party - divisions within the House GOP caucus and divisions between House and Senate Republicans - the fiscal year ended with the Labor-HHS bill and the Defense appropriations bill that represent 67 percent of the discretionary spending in our budget bill still being hung up in the legislative process.
"Now in the closing days of this Congress, the Republican Leadership has decided to use the must-pass Defense appropriations bill to force down the throats of the American people a number of wholly unrelated gifts to special interests. They decided to hold funds for our troops hostage in order to force Congress into removing protections against oil drilling in ANWR. To make room for their tax giveaways, they even imposed a second round of cuts to education, health, worker protection, and even imposing a $4 billion cut in military spending.
"Senate action yesterday has corrected one provision inserted in the bill by abuse of power - the strong-arm attempt at drilling in ANWR - and for that I mildly applaud the Senate. I led the opposition to ANWR's inclusion in the Conference and I am happy that the Congress was not blackmailed into accepting it.
"But frankly Mr. Speaker, continuing under my reservation, ANWR was not the biggest problem with the Conference report. The biggest problem is that it shortchanges our economic future by refusing to make adequate investments in education and it cruelly neglects to strengthen support for programs that help provide critical health care services to people who desperately need them. But we have lost that fight. This Congress has made the decision to cut critical health, education, worker protection, and social service funding by $3 billion below last year's level. What I find to be so gutless about Congress' performance on this bill is that those cuts could not pass the Senate on a roll call vote, so the Majority party had to arrange for their Senators to duck this vote and hide from accountability by arranging for the bill to be passed without a roll call vote. That means the Majority party has denied critical help to families most in need of help, but has not had the courage to forthrightly defend their votes to the people affected in the public arena. This bill makes that problem $1.4 billion worse for those programs and because of the across-the-board cut, it makes other ill-advised cuts in critical funding for the FBI, local law enforcement, and it even cuts an additional $4 billion out of the defense bill. If I could do anything to change that, I would. But it is clear that the die is cast.
"Continuing under my reservation Mr. Speaker, there is a second outrageous problem with this bill. The Majority has turned the proposal to prepare for a flu pandemic into a giveaway to the pharmaceutical industry.
"When the President requested $7 billion to begin a much belated crash program to develop a new generation of vaccines and antiviral drugs to combat a potential flu pandemic, the Republican Majority responded by cutting it in half. When I asked Senator Stevens in Conference why we shouldn't fund the rest of the Administration's request so that it was clear that the government had a long-term commitment to the development of needed vaccines and antivirals, he responded that because liability protection language for manufacturers was not being adopted, long-range funding should be withheld. The Conference Committee ended its work with an understanding, both verbal and in writing, that there would be no -- I repeat no -- legislative liability protection language inserted in this bill. And because the Majority told us it did not want any compensation program for victims to come out of the discretionary portion of the budget, no funding was provided for that either. But after the Conference was finished at 6pm, Senator Frist marched over to the House side of the Capitol about four hours later and insisted that 40 pages of legislation - which I have in my hand - 40 pages of legislation that had never been seen by Conferees be attached to the bill. The Speaker joined him in that insistence so that, without a vote of the Conferees, that legislation was unilaterally and arrogantly inserted into the bill after the Conference was over in a blatantly abusive power play by two of the most powerful men in Congress. We then discovered that this language provided all sorts of insulation for pharmaceutical companies and that this insulation applied not just to drugs developed to deal with the flu, but in fact applied to a far broader range of products.
"In essence, the provisions allow the Secretary of HHS to issue a declaration that has the effect of almost completely prohibiting lawsuits in state or federal courts by persons whose health was injured against manufacturers and various others for compensation for injuries caused by the use of "covered countermeasures." That determination would bar lawsuits against a wide range of "covered persons" involved with the countermeasures-including manufacturers and their suppliers, distributors, state and local governments and their employees involved with use of the countermeasures, medical personnel prescribing and administering the countermeasures, and so forth. This is very broad power indeed to ban lawsuits. Unlike the language requested by the Administration, the Division E language is not limited to products to combat a flu pandemic. Rather, it applies to any drug, vaccine, medical device or other products useful in dealing with anything the Secretary considers to constitute a public health emergency or that could constitute an emergency in the future.
"Although a rationale often offered for lawsuit protection is that it is needed to encourage manufacturers to develop and produce new treatments, the protections of Division E are not limited to new or experimental products. Rather, nothing in the language would prevent the Secretary from providing protection against lawsuits to drugs that have been on the market for decades.
"Further, the language explicitly prohibits any judicial review, in either federal or state court, of the Secretary's decisions to grant immunity from lawsuits. If anyone believes that the power is being exercised too broadly, or even in violation of the law, they apparently would have no remedy other than asking the Secretary to change his mind or asking Congress to amend the law.
"Although proponents point to provisions of this language that make an exception and allow lawsuits in cases of willful misconduct, that exception is so narrowly drawn as to be almost meaningless. First, the provision defines "willful misconduct" as acts taken "intentionally to achieve a wrongful purpose", knowing there is no legal or factual justification, and in disregard of known or obvious great risk. Basically, Mr. Speaker, the only conduct that would permit a lawsuit under this definition is probably conduct so egregious as to be criminal in nature.
"However, even this highly restrictive definition of "willful misconduct" doesn't seem to have been enough restriction on lawsuits to satisfy the authors of Division E. They added yet another provision that allows the Secretary of HHS to promulgate regulations further narrowing the scope of actions that could give rise to a right to sue. Then, there's yet another provision that says if the conduct in question is regulated under the Food and Drug Act or Public Health Service Act, a lawsuit for willful misconduct can be brought only if the federal government has taken enforcement action against that conduct. Finally, the language makes various changes to the normal rules of civil procedure to add further obstacles and difficulties in front of a potential plaintiff. In short, as a practical matter there is virtually no right for anyone to sue about anything covered by a Secretarial determination under this language.
"In summary, the Administration asked for some very broad liability protections for manufacturers and others involved with countermeasures against pandemic flu - and the Administration's proposal was widely criticized as going too far. With Division E of the Defense appropriations Conference report, Congress would be providing even broader protection, potentially covering a wide range of drugs, vaccines and devices far beyond what is needed to deal with the flu.
"Further, this denial of the right to sue is more sweeping than provided in the case of childhood vaccines, or in the case of smallpox vaccine. In the smallpox case, manufacturers are protected by basically substituting the federal government as defendant-with the scope of potential lawsuits against the federal government narrowed but not eliminated.
"Now Mr. Speaker, I recognize that some sort of liability protection or indemnification that would be necessary and appropriate to encourage development and manufacture of some measures to deal with pandemic flu and I would support such reasonable language, language that has been reviewed by a Committee that knows what it is doing in a process that allows for public comments. But there are real doubts as to whether it needs to be this broad. Its worth noting that Sanofi Pasteur, our only domestic flu vaccine manufacturer, has already signed contracts with the federal government to make avian flu vaccine and has already delivered some lots, rather than refusing to proceed until legislation like this is enacted. Similarly, Roche has been supplying Tamiflu for the national stockpile and actively seeking contracts to supply more.
"The result of this legislative action was a provision in the pending bill that prevents anyone who is a victim of a faulty vaccine from being able to obtain compensation in the courts. It says that if you become seriously ill because of mistakes in the manufacturing, that you lose your right to sue for compensation, but you can seek compensation from the government. But guess what -- the problem is that no money was provided for that fund. So anyone who gets sick would have to lobby Congress to put money in the money in the fund before they can collect. Thus, people injured lose their right to sue, but are not guaranteed any alternative means of covering their medical bills, lost earnings and other costs.
"Mr. Speaker, the Committee system was created years ago to ensure that to protect the public interest, legislation would be carefully reviewed before it was placed before the body for consideration. But that protection was arbitrarily by-passed by the Leadership in both Houses.
"This is the second time that this Congress has supinely done the bidding of the pharmaceutical industry in the dead of night. The first time, a vote was held open for three hours while the Republican Majority twisted arms to create the complex and ridiculously confusing prescription drug bill that our seniors are now so desperately trying to understand - a bill that was ushered through this institution by over 600 lobbyists and that protected companies by preventing the government from even attempting to negotiate lower drug prices.
"If I thought that denying unanimous consent on this bill would force the Majority to eliminate that language I would object. But, Mr. Speaker, it has also been made quite clear to me that the Majority will not relent on the language that insulates drug companies. So Mr. Speaker, I want it to be clear that the action to insert this special interest language in the bill is in my view a corruption of the legislative practices of the House. When Congress returns in January, I intend to raise a question about the privileges of the House that are highlighted by this action because it has brought discredit to the House and should disturb every Member who serves here. No Member of Congress, no matter how powerful, should be able to unilaterally insist that provisions that were never discussed and never debated in the Conference should be slipped in to that Conference report without a vote of that same Conference.
"This is what happens when there are no checks and balances, when one party controls the White House, the Senate, and the House and respects no limits on its own use of power. We have been placed in the this position because the House Republican Leadership has sent Members home for the Christmas holidays with the message to the Senate that we would not be here even if the Senate changed the legislation the House sent. That was irresponsible and the country will pay the price. This institution will pay a price as well, in terms of diminished respect from the people we were elected to represent. Members on both sides know it and it is time to have a modicum of respect for the way we do the people's business.
"This is a shameful and shabby way to the end the worst session of Congress I've experienced in 36 years in Congress. I most reluctantly withdraw my reservation because lodging an objection at this point would simply delay the shameful inevitable."
forwarded by Zeus Information Service Alternative Views on Health
http://www.zeusinfoservice.com
Informant: Gomez
From: Emma Holister Emma's cartoons attached to this article Senate Moves Towards Forced Vaccinations, Vaccine Damage Immunity for Drug Companies Associated Press | December 2, 2005
By ANDREW BRIDGES RELATED:
CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES
By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.
The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from long-standing open records and meetings laws that apply to most government departments, according to legislation approved Oct. 18 by the Senate health committee.
Those exemptions would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill. The legislation also proposes giving manufacturers immunity from liability in exchange for their participation in the public-private effort.
"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Sen. Richard Burr, R-N.C., said when the Committee on Health, Education, Labor and Pensions approved the bill.
The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics as well as chemical, biological and radiological agents.
But it is the secrecy and immunity provisions of the legislation that have alarmed patient rights and open government advocates. The agency would be exempt from the Freedom of Information and Federal Advisory Committee acts, both considered crucial for monitoring government accountability.
"There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. "That is a cause for major concern and should raise major policy concerns," Weitzel said.
Burr spokesman Doug Heye said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential business information already is exempt from FOIA.
"There's no secrecy involved in BARDA," Heye said. "That is absolutely false. This is an agency that will be putting out information daily."
Some Democrats question whether the public would accept drugs or vaccines developed in conjunction with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line health care workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about the vaccine's safety, which health authorities initially downplayed.
"Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement. "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."
The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless "willful misconduct" can be shown.
The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill. Another industry group, the Biotechnology Industry Organization, declined comment.
The National Vaccine Information Center, an advocacy group, called the legislation "a drug company stockholder's dream and a consumer's worst nightmare."
The proposed law comes amid growing concern about pandemics and the government's ability to meet such threats. For instance, the United State needs another three to five years to develop the manufacturing capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday on NBC's "Meet the Press."
The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.
"While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said. "One of the reasons is (they) don't want to put their very existence on the line."
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the agency as proposed would represent a setback to decades of progress in opening up to the public the process of testing the safety and efficacy of drugs.
"These provisions are extremely dangerous," Wolfe said. "The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics, is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act to increase public scrutiny and increase the correctness of decisions that are made."
Republican and Democratic lawmakers alike agree the drug industry needs some protections to encourage it to produce emergency stocks of vaccines and drugs, but Democrats have balked at providing blanket immunity without first establishing a compensation fund for patients.
Republicans are pushing for liability protections for vaccine manufacturers on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking to add such protections to a defense appropriations bill.
Frist spokeswoman Amy Call said drug company concerns about liability are real.
"There's really no financial incentive for them to get into the market, sell to the government at a reduced rate and then open themselves up to losses that could potentially bankrupt them," Call said.
The push for liability exemptions may force the Burr bill to the sidelines until the next session of Congress, Republican and Democratic aides said. But Call said Frist intends to pursue the legislation.
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Thanks to Sheri Nakken, R.N., MA, Classical Homeopath, for sending the articles below:- http://www.nccn.net IMMUNITY FOR THE DRUG INDUSTRY 22/12/05 - Written by the Democratic Health, Education, Labor, and Pensions Staff, addressing scandalous language added in once again by Senator Frist, in a must pass DoD appropriations bill:
In the middle of the night, Republican leaders attached sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report. The language constitutes an unprecedented pharmaceutical industry wish-list of liability protections that go way beyond avian flu preparedness and that will allow the industry to injure or kill Americans with contaminated drugs and vaccines and never be held accountable. This language is broader than any House or Senate bill and has never been considered by any committee or passed by either body. The language in fact, even expressly immunizes pharmaceutical company recklessness.
The language:
Applies to a wide range of drugs, vaccines, and other products. The proposal provides that any "drug, biological product or device that is used to mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause." may be covered and given immunity. The proposal does not, in any way, limit its application only to new drugs or vaccines used in a pandemic context. The scope of the proposal is so broad that it could include drugs like Tylenol, Advil or Vioxx.
Allows the Secretary to declare an emergency under ANY circumstance. The immunity for drug companies is triggered upon a declaration by the Secretary of Health and Human Services (HHS). The language is so broad that it allows the Secretary to make a declaration at any time, for almost any reason, and for any period of time he or she so chooses. The Secretary may make a declaration pursuant to this section if a disease or health condition is a public health emergency or "there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency." [emphasis added.] There will always be a future risk of a health condition becoming an emergency, but that future risk alone should not be enough to justify total immunity for the pharmaceutical industry. This declaration is not subject to appeal, or to any independent judicial review.
Provides for total preemption of state law during the declaration. The language also preempts all state laws, requirements, or state tort law that is different from or in conflict with the federal rule.
Immunizes drug companies for reckless and grossly negligent conduct. The only exception to the grant of wholesale immunity is in the case of "willful misconduct." However, willful misconduct is defined as evidence that the drug company had actual knowledge that their product would injure or kill someone. This requirement means that only conduct that would also constitute assault, battery or murder would be sufficient to find "willful misconduct." The language explicitly protects recklessness by stating, "a standard for liability that is more stringent that a standard of negligence in any form or recklessness." That is language never before seen in any proposed bill.
Immunizes criminal conduct when the Secretary or the Attorney General fails to act. Even if a drug company has acted with "willful misconduct" as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.
Erects insurmountable barriers such that Americans will never be able to hold a drug company accountable. Under the language, a person who has been injured by a dangerous drug or vaccine must prove "by clear and convincing evidence willful misconduct" on the part of each and every defendant drug company. This standard of proof is so high, and rarely used in civil proceedings, that the injured individual will never be able to hold a drug company accountable.
Includes severe restrictions even if a claim is allowed. In the unlikely event that a claim is allowed to go forward because a court has found sufficient evidence that a drug company intentionally and willfully injured or killed a person, the following restrictions would still apply:
* The complaint must be accompanied by physician's affidavit by a doctor who did not treat the person that the person is suffering from an effect of the covered countermeasure;
* The injured individual must provide their medical records that show that the injury was caused by that countermeasure;
* An exclusive federal cause of action, barring individuals from filing a claim in their own state court under state law;
* The elimination of the collateral source rule such that any damage award received by the injured person would be reduced by any other payment received by the individual, such as health insurance or disability benefits;
Includes provisions of the so-called "Lawsuit Abuse Reduction Act" (LARA). Proponents have even dumped into this proposal provisions of LARA, a bill which has twice passed the House but has never been considered in the Senate. Among other things, the proposal would amend the Federal Rules of Civil Procedure without following the normal rule-making processes.
Establishes a "compensation" fund under the sole direction of the Secretary. The language establishes a fund similar to the smallpox compensation fund. However, the fund is operated under regulations established by the Secretary alone, includes caps on compensation, and is inoperable until Congress appropriates a sufficient amount of money for the fund to operate.
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"Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines against human papilloma virus, a sexually transmitted disease that is a major cause of cervical cancer, could be big sellers for Merck & Co. and Glaxo who are each developing one. "
http://www.thnt.com/apps/pbcs.dll/article?AID=/20051211/BUSINESS/512110337/1003
Drug makers seek protection
Home News Tribune Online 12/11/05
THERESA AGOVINO THE ASSOCIATED PRESS
NEW YORK - Large pharmaceutical companies are approaching development of vaccines and drugs for potential pandemics with trepidation, even as fears abound of a bird flu outbreak and doctors lament a shortage of treatment options.
Drug makers are especially afraid of lawsuits stemming from vaccines which, unlike drugs, are given to healthy people, making any harm they cause an even bigger legal risk.
Proposals in Congress would exempt companies that manufacture vaccines and drugs for pandemics from lawsuits. Senator Bill Frist, R-Tenn., is trying to put a rider on a spending bill that would immunize drug makers and another freestanding bill introduced by Senator Richard Burr, R-N.C., seeks to accomplish the same goal.
That's a necessary safeguard to promote interest in developing those medicines, drug makers say.
"We won't do it without indemnification," said Len Lavenda, a spokesman for Sanofi Pasteur, the vaccine arm of Sanofi-Aventis SA.
But some insist immunizing drug companies won't be enough to spark interest in a field fraught with an uncertain pricing structure. Unlike drugs for conditions such as cholesterol and high blood pressure, which have guaranteed markets, medicines for pandemics will only be used sporadically, if at all.
The government adds to the pricing pressure. The Centers for Disease Control and Prevention buys 55 percent of the recommended childhood vaccines and pays substantially less than the private sector, so some experts suspect payments for pandemic treatments will be less than generous.
When anthrax fears surfaced after the Sept. 11 attacks, the U.S. government threatened to break the patent covering Cipro, an antibiotic made by Bayer AG. And Roche Holding Ltd. has already been under tremendous pressure to lower the cost of its Tamiflu, which is believed to be effective against bird flu, and give others permission to make it.
"Companies are worried about low prices," said Frank Sloan, professor of health policy, law and management at Duke University.
"They are worried they won't recoup their research and development costs," he said. "That is the real problem."
In a statement, Senator Edward Kennedy, D-Mass., called the attempts to indemnify companies "a sweetheart deal for the drug industry."
A spokesman for Burr said his bill contains provisions to compensate people hurt from treatments through government funds and that companies will only be indemnified when the product is used in a pandemic, not for a general medical problem.
The drug industry insists such moves are crucial. In a pandemic, a vaccine may be approved without the same level of testing that would be normally required and given to virtually all Americans.
"This is 300 million plaintiffs you are talking about," said John Clerici, a lawyer who represents Sanofi and other companies. "If they get anything, they'll blame it on the vaccine."
Sheltering drug companies from lawsuits isn't without precedent. Acambis PLC was protected to make an Anthrax vaccine and the manufacturers of swine flu vaccines were given the same treatment back in the 1970s.
Individuals seriously harmed by vaccines the U.S. government recommends for children are paid through a federal pool funded by a tax on inoculations. But Lavenda said lawyers are seeking ways to collect damages from companies instead of the government fund.
Chris Viehbacher, president of GlaxoSmithKline PLC's U.S. pharmaceuticals business, estimates the industry has spent $200 million preparing itself for lawsuits over a vaccine preservative in children' s vaccines.
Lavenda said the issue of immunity from lawsuits must be cleared before other negotiations can begin on issues such as price.
Lobbyists and pharmaceutical executives said the main force pushing for indemnity is not the drug industry, but the Biotechnology Industry Organization, a trade group. BIO declined comment, but lobbyists and analysts suggested its members are far more interested in pandemic medicines than drug companies.
"Biotech companies are more amenable to working in new areas. They are startups," said Christopher Milne, assistant director at the Tufts Center for the Study of Drug Development. "Big pharmaceutical companies are resistant to getting heavily involved where the government is paying. They remember the Cipro incident."
Generex Biotechnology Corp. recently hired a lobbying firm to help it get government contracts to develop its bird flu vaccine.
Anna Gluskin, Generex's chairwoman, CEO and president, said she isn't worried about lawsuits because the company's vaccine is made from synthetic proteins, which she maintains is a safer manufacturing process.
Some pharmaceutical companies have chosen to develop a vaccine for bird flu. Sanofi Pasteur has a government contract to produce 8,000 doses of an experimental vaccine, but it has received indemnity from lawsuits. Glaxo said it will start a small trial in Europe during the first quarter of next year, and discussions with regulators haven't progressed enough to have included the indemnity issue.
Viehbacher said any company which successfully creates a vaccine would have leverage over the government. Vaccine production is complicated, so breaking a patent wouldn't guarantee supply, he said.
Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines against human papilloma virus, a sexually transmitted disease that is a major cause of cervical cancer, could be big sellers for Merck & Co. and Glaxo who are each developing one.
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U.S. Senators with up to $13.4 million in pharmaceutical holdings increased the value of their stock portfolios last night when they approved an amendment to the defense appropriations bill that immunizes drug makers from accountability to the public when they sell dangerous drugs and other products, according to the Foundation for Taxpayer and Consumer Rights (FTCR).
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http://www.whitehouse.gov/news/releases/2005/12/20051222-10.html
President Applauds Congress for Passing Defense Appropriations Bill I applaud the Congress for passing legislation to fund our troops who are fighting the war on terror in Iraq, Afghanistan, and elsewhere. This funding will help us continue to hunt down the terrorists, pursue our strategy for victory in Iraq, and make America more secure. I look forward to signing the bill into law.
What the president does not mention in the 'making of America more secure' - is that in the bill, Senator Frist slipped language into the bill indemnifying manufacturers from their products (drugs/vaccines, et. al) that can harm, disable and/or kill the American people. The arctic drilling was widely focussed on, and that amendment was pulled from the bill. The environment in Alaska is now safe - Americans in the US however, are now not. What the president also fails to mention is that he was the #1 recipient of contribution funds for the 2004 election, bringing in over $1,000,000.00 from PHARMA.
http://www.secretwebsites.com/say_no_to_drugs.htm - For those that believe I'm slamming Republicans, I am not - it just so happens those mainly responsible are Republicans - but, there are a few democrats as well.
Again, here are the 38 senators that voted this bill in, with a conflict of interest with ties to the pharmaceuticals (stock holdings):
Allen (R-Va.), Bayh (D-Ind.), Bingaman (D-N.M.), Bond (R-Mo.), Boxer (D-Calif.), Brownback (R-Kan.), Burns (R-Mont.), Carper (D-Del.), Coburn (R-Okla.), Cochran (R-Miss.), Conrad (D-N.D.), Crapo (R-Idaho), Dayton (D-Minn.), DeWine (R-Ohio), Dole (R-N.C.), Ensign (R-Nev.), Feinstein (D-Calif.), Frist (R-Tenn.), Hatch (R-Utah), Hutchison (R-Texas), Inhofe (R-Okla.), Isakson (R-Ga.), Kerry (D-Mass.), Kyl (R-Ariz.), Landrieu (D-La.), Lautenberg (D-N.J.), Levin (D-Mich.), Lieberman (D-Conn.), Lott (R-Miss.), Reed (D-R.I.), Reid (D-Nev.), Roberts (R-Kan.), Stevens (R-Alaska), Sununu (R-N.H.), Talent (R-Mo.), Vitter (R-La.), Voinovich (R-Ohio) and Warner (R-Va.).
If you notice that your state/senator is listed above, congratulations - you just noticed that your Senator just screwed you over (don't expect a dinner - and remember this on election day). If you think that PHARMA does not run this country, think again. PHARMA has just proven that they can buy and even own Congress and the President. With all the hype on "protecing america against the war on terrorism" - today, America has just been taken hostage by its own government.
Read the below statemement from Dem. David Obey (WI) - it is long, but, it is very much worth the read. There are few exceptions to those in power who I believe are trying to do the right thing for their constituents and America - this gentleman below is one of them.
House Committee On Appropriations, Democratic Staff David R. Obey (WI-07), Ranking Member For Immediate Release Contact: Kirstin Brost December 22, 2005
202-593-1310
Obey Statement on Defense Appropriations Correction Bill
A Shameful End to a Shameful Congress
WASHINGON -Dave Obey (D-WI), Ranking Member of the House Appropriations Committee, made the following statement this afternoon on the bill stripping the provision to allow drilling in the Arctic National Wildlife Refuge (ANWR) from the Defense Appropriations Conference report:
"Mr. Speaker, reserving the right to object: "More than a year ago, when Mr. Lewis was elected Chairman of the Appropriations Committee, he came to me and asked if we could have an understanding that we would express our substantive differences but still cooperate in moving bills forward in an orderly way once those differences had been expressed. We did that.
"Time and time again, the Minority was denied the opportunity to offer different sets of priorities, priorities that did not offer huge tax cuts for those who have the most in society, paid for with cuts in education, health care, and worker protection for those who have the least. Despite the fact that the rules of the House were used to block our efforts to obtain on-the-record votes on a number of our alternatives, Democrats continued to cooperate procedurally, even as we made clear our differences on policy.
"The Republican Majority wanted to finish all of these bills by the end of the fiscal year, and we did not procedurally obstruct them because while we differed strongly with the values that lie behind their budget priorities, we respected the fact that they are in the Majority and we respect and revere this institution. But because of internal divisions between the Majority party - divisions within the House GOP caucus and divisions between House and Senate Republicans - the fiscal year ended with the Labor-HHS bill and the Defense appropriations bill that represent 67 percent of the discretionary spending in our budget bill still being hung up in the legislative process.
"Now in the closing days of this Congress, the Republican Leadership has decided to use the must-pass Defense appropriations bill to force down the throats of the American people a number of wholly unrelated gifts to special interests. They decided to hold funds for our troops hostage in order to force Congress into removing protections against oil drilling in ANWR. To make room for their tax giveaways, they even imposed a second round of cuts to education, health, worker protection, and even imposing a $4 billion cut in military spending.
"Senate action yesterday has corrected one provision inserted in the bill by abuse of power - the strong-arm attempt at drilling in ANWR - and for that I mildly applaud the Senate. I led the opposition to ANWR's inclusion in the Conference and I am happy that the Congress was not blackmailed into accepting it.
"But frankly Mr. Speaker, continuing under my reservation, ANWR was not the biggest problem with the Conference report. The biggest problem is that it shortchanges our economic future by refusing to make adequate investments in education and it cruelly neglects to strengthen support for programs that help provide critical health care services to people who desperately need them. But we have lost that fight. This Congress has made the decision to cut critical health, education, worker protection, and social service funding by $3 billion below last year's level. What I find to be so gutless about Congress' performance on this bill is that those cuts could not pass the Senate on a roll call vote, so the Majority party had to arrange for their Senators to duck this vote and hide from accountability by arranging for the bill to be passed without a roll call vote. That means the Majority party has denied critical help to families most in need of help, but has not had the courage to forthrightly defend their votes to the people affected in the public arena. This bill makes that problem $1.4 billion worse for those programs and because of the across-the-board cut, it makes other ill-advised cuts in critical funding for the FBI, local law enforcement, and it even cuts an additional $4 billion out of the defense bill. If I could do anything to change that, I would. But it is clear that the die is cast.
"Continuing under my reservation Mr. Speaker, there is a second outrageous problem with this bill. The Majority has turned the proposal to prepare for a flu pandemic into a giveaway to the pharmaceutical industry.
"When the President requested $7 billion to begin a much belated crash program to develop a new generation of vaccines and antiviral drugs to combat a potential flu pandemic, the Republican Majority responded by cutting it in half. When I asked Senator Stevens in Conference why we shouldn't fund the rest of the Administration's request so that it was clear that the government had a long-term commitment to the development of needed vaccines and antivirals, he responded that because liability protection language for manufacturers was not being adopted, long-range funding should be withheld. The Conference Committee ended its work with an understanding, both verbal and in writing, that there would be no -- I repeat no -- legislative liability protection language inserted in this bill. And because the Majority told us it did not want any compensation program for victims to come out of the discretionary portion of the budget, no funding was provided for that either. But after the Conference was finished at 6pm, Senator Frist marched over to the House side of the Capitol about four hours later and insisted that 40 pages of legislation - which I have in my hand - 40 pages of legislation that had never been seen by Conferees be attached to the bill. The Speaker joined him in that insistence so that, without a vote of the Conferees, that legislation was unilaterally and arrogantly inserted into the bill after the Conference was over in a blatantly abusive power play by two of the most powerful men in Congress. We then discovered that this language provided all sorts of insulation for pharmaceutical companies and that this insulation applied not just to drugs developed to deal with the flu, but in fact applied to a far broader range of products.
"In essence, the provisions allow the Secretary of HHS to issue a declaration that has the effect of almost completely prohibiting lawsuits in state or federal courts by persons whose health was injured against manufacturers and various others for compensation for injuries caused by the use of "covered countermeasures." That determination would bar lawsuits against a wide range of "covered persons" involved with the countermeasures-including manufacturers and their suppliers, distributors, state and local governments and their employees involved with use of the countermeasures, medical personnel prescribing and administering the countermeasures, and so forth. This is very broad power indeed to ban lawsuits. Unlike the language requested by the Administration, the Division E language is not limited to products to combat a flu pandemic. Rather, it applies to any drug, vaccine, medical device or other products useful in dealing with anything the Secretary considers to constitute a public health emergency or that could constitute an emergency in the future.
"Although a rationale often offered for lawsuit protection is that it is needed to encourage manufacturers to develop and produce new treatments, the protections of Division E are not limited to new or experimental products. Rather, nothing in the language would prevent the Secretary from providing protection against lawsuits to drugs that have been on the market for decades.
"Further, the language explicitly prohibits any judicial review, in either federal or state court, of the Secretary's decisions to grant immunity from lawsuits. If anyone believes that the power is being exercised too broadly, or even in violation of the law, they apparently would have no remedy other than asking the Secretary to change his mind or asking Congress to amend the law.
"Although proponents point to provisions of this language that make an exception and allow lawsuits in cases of willful misconduct, that exception is so narrowly drawn as to be almost meaningless. First, the provision defines "willful misconduct" as acts taken "intentionally to achieve a wrongful purpose", knowing there is no legal or factual justification, and in disregard of known or obvious great risk. Basically, Mr. Speaker, the only conduct that would permit a lawsuit under this definition is probably conduct so egregious as to be criminal in nature.
"However, even this highly restrictive definition of "willful misconduct" doesn't seem to have been enough restriction on lawsuits to satisfy the authors of Division E. They added yet another provision that allows the Secretary of HHS to promulgate regulations further narrowing the scope of actions that could give rise to a right to sue. Then, there's yet another provision that says if the conduct in question is regulated under the Food and Drug Act or Public Health Service Act, a lawsuit for willful misconduct can be brought only if the federal government has taken enforcement action against that conduct. Finally, the language makes various changes to the normal rules of civil procedure to add further obstacles and difficulties in front of a potential plaintiff. In short, as a practical matter there is virtually no right for anyone to sue about anything covered by a Secretarial determination under this language.
"In summary, the Administration asked for some very broad liability protections for manufacturers and others involved with countermeasures against pandemic flu - and the Administration's proposal was widely criticized as going too far. With Division E of the Defense appropriations Conference report, Congress would be providing even broader protection, potentially covering a wide range of drugs, vaccines and devices far beyond what is needed to deal with the flu.
"Further, this denial of the right to sue is more sweeping than provided in the case of childhood vaccines, or in the case of smallpox vaccine. In the smallpox case, manufacturers are protected by basically substituting the federal government as defendant-with the scope of potential lawsuits against the federal government narrowed but not eliminated.
"Now Mr. Speaker, I recognize that some sort of liability protection or indemnification that would be necessary and appropriate to encourage development and manufacture of some measures to deal with pandemic flu and I would support such reasonable language, language that has been reviewed by a Committee that knows what it is doing in a process that allows for public comments. But there are real doubts as to whether it needs to be this broad. Its worth noting that Sanofi Pasteur, our only domestic flu vaccine manufacturer, has already signed contracts with the federal government to make avian flu vaccine and has already delivered some lots, rather than refusing to proceed until legislation like this is enacted. Similarly, Roche has been supplying Tamiflu for the national stockpile and actively seeking contracts to supply more.
"The result of this legislative action was a provision in the pending bill that prevents anyone who is a victim of a faulty vaccine from being able to obtain compensation in the courts. It says that if you become seriously ill because of mistakes in the manufacturing, that you lose your right to sue for compensation, but you can seek compensation from the government. But guess what -- the problem is that no money was provided for that fund. So anyone who gets sick would have to lobby Congress to put money in the money in the fund before they can collect. Thus, people injured lose their right to sue, but are not guaranteed any alternative means of covering their medical bills, lost earnings and other costs.
"Mr. Speaker, the Committee system was created years ago to ensure that to protect the public interest, legislation would be carefully reviewed before it was placed before the body for consideration. But that protection was arbitrarily by-passed by the Leadership in both Houses.
"This is the second time that this Congress has supinely done the bidding of the pharmaceutical industry in the dead of night. The first time, a vote was held open for three hours while the Republican Majority twisted arms to create the complex and ridiculously confusing prescription drug bill that our seniors are now so desperately trying to understand - a bill that was ushered through this institution by over 600 lobbyists and that protected companies by preventing the government from even attempting to negotiate lower drug prices.
"If I thought that denying unanimous consent on this bill would force the Majority to eliminate that language I would object. But, Mr. Speaker, it has also been made quite clear to me that the Majority will not relent on the language that insulates drug companies. So Mr. Speaker, I want it to be clear that the action to insert this special interest language in the bill is in my view a corruption of the legislative practices of the House. When Congress returns in January, I intend to raise a question about the privileges of the House that are highlighted by this action because it has brought discredit to the House and should disturb every Member who serves here. No Member of Congress, no matter how powerful, should be able to unilaterally insist that provisions that were never discussed and never debated in the Conference should be slipped in to that Conference report without a vote of that same Conference.
"This is what happens when there are no checks and balances, when one party controls the White House, the Senate, and the House and respects no limits on its own use of power. We have been placed in the this position because the House Republican Leadership has sent Members home for the Christmas holidays with the message to the Senate that we would not be here even if the Senate changed the legislation the House sent. That was irresponsible and the country will pay the price. This institution will pay a price as well, in terms of diminished respect from the people we were elected to represent. Members on both sides know it and it is time to have a modicum of respect for the way we do the people's business.
"This is a shameful and shabby way to the end the worst session of Congress I've experienced in 36 years in Congress. I most reluctantly withdraw my reservation because lodging an objection at this point would simply delay the shameful inevitable."
forwarded by Zeus Information Service Alternative Views on Health
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Informant: Gomez
Starmail - 10. Jan, 09:18
