Legal immunity set for swine flu
vaccine makers: What are the


AP Medical Writer Mike Stobbe got a swine flu vaccine scoop--yet the news is four weeks old. It turns out that DHHS Secretary Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu. She also granted immunity to future swine flu vaccines and "any associated adjuvants," which was published in the June 25, 2009 Federal Register. Here is the start of his story:

The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.


Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.


Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies.

It allows for a compensation fund, if needed...
However, the compensation issue is more difficult than portrayed by Stobbe. The special vaccine court to which Stobbe refers applies only to specially designated vaccines, excludes most adult vaccines, and swine flu is not a designated vaccine for which compensation can be paid.

The 2006 Public Readiness and Emergency Preparedness Act (PREPA) allows the DHHS Secretary to invoke almost complete immunity from liability for manufacturers of vaccines and drugs used to combat a declared public health emergency. PREPA removes the right to a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury, and gets permission to sue from the DHHS Secretary. There has been no government funding of its potential compensation mechanism, to date. Furthermore, a PREPA declaration explicitly shields "government program planners" who arranged for the liability waiver.

2006年パブリック レディーネス アンド イマジンシー プリペアードネス条例(2006年度公共危機管理、危機対応準備条例。略してPREPA)は保健社会福祉省局長が市民の健康に対する危機と宣言された病気に対して使われるワクチンや薬を生産した製薬会社に対する殆ど完全な法的責任の免除を与える事を許している。PREPAは原告が意図的違法行為が死亡や重症の原因となり、そして訴訟を起こす許可を保健社会福祉省長官から得ると言う確かな証拠の提出が出来なければ、ワクチンによる被害者から陪審員の参加している裁判を受ける権利を剥奪している。現在に至るまで予想される政府の払う賠償金制度は準備されていない。其れに加えてPREPAの宣言書は此の支払い責任削除を仕組んだ政府のプログラム制作者を明確に保護している。

Pharmaceutical companies making swine flu vaccine today may have demanded immunity from liability before agreeing to begin a crash program to manufacture H1N1 vaccine for the government. According to a 1978 report by the National Academy of Sciences, something similar happened with the 1976 swine flu program:

現在豚インフルエンザワクチンを作る製薬会社はH1N1ワクチンを政府の為に製造する緊急プログラムに同意する前に賠償責任からの保護を要求したのかも知れない。1978年のナショナル アカデミー オブ サイエンスの報告によると1976年の豚インフルエンザワクチン プログラムに起こった同様な事が起こったと言う事である。
... all manufacturers made plain that they would not insure themselves, not even temporarily. Instead they put off plans to bottle their vaccine; pending legislation they would keep the stuff in bulk. Each week’s delay in moving from bulk to bottles assured at least as much delay in starting inoculations. Thus ended hopes of immunizing anybody in July or even August...

Behind Merrell’s firmness, there almost certainly was fear of the intentions of the casualty insurers. In May it was no secret that at least some major firms wanted to steer clear of swine vaccine. As early as April 8 Merck had been warned by its primary insurer that coverage for swine vaccine was “considered” not “feasible … at virtually any price.” So Merck's President had written Mathews and everyone else in sight.

Merrell, then about to switch insurers (for unrelated reasons) is reported to have been told by its new one something of the same sort at about the same time. We do not know precisely what was made of this, where in Merrell’s management. We do know that the issue was reviewed again, in June, by the insurer with the same result, a “no.” But we assume that Merrell’s counsel knew in May what the insurer had already warned in April. However that may be, it shortly would turn out that all insurers saw the swine flu program much alike: not for them.

Here is the problem: once the PREP Act is invoked to shield manufacturers from liability, the pharmaceutical firms have no financial incentive to make the safest product, and have a negative incentive to test it for safety. As long as they do not deliberately harm consumers of the product, they will not be liable for damages.


Are you following this argument closely? In order to avoid having prior knowledge of possible harm to users of the product, for which they could be found liable, it is in the manufacturers' best interest to know as little as possible about adverse reactions caused by their product.


Thus manufacturers can be expected to perform minimal testing, as they have been incentivized by PREPA to avoid learning of potential harms related to their product. The rush to manufacture and administer new vaccines serves two purposes: it provides an excuse to avoid adequate testing, as well as providing rapid vaccine availability. For example, see this Bloomberg article, "Glaxo to Limit Tests of Flu Vaccine, Citing Urgency."


On the other hand, France, which has ordered vaccines from Sanofi, Glaxo and Novartis AG, sees no reason at this point to ask vaccine makers to shorten or skip clinical trials, Health Minister Roselyne Bachelot-Narquin said at a news conference.

一方でSanofi, Glaxo Novartis AG,等にワクチンを注文したフランスでは、現時点でワクチン製造業者に臨床実験を短縮したり排除したりする根拠は見当たらないと健康保健省大臣ロザリン バシェロ-ナルキンはニュースコンファレンスで述べている。

It is worthwhile to go back and consider the reason for passing PREPA in 2006: fear of an avian flu pandemic, in the event the avian flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate. Faced with such a potentially devastating disease, it perhaps made sense to create legislation to permit rapid deployment of drugs and vaccines without adequate testing, and issue a liability shield for those involved in the process.


But the H1N1 flu has only caused 302 US deaths though CDC over one million Americans had been infected. Instead of 70%, H1N1's death rate is under 0.03%. Therefore, this virus in no way justifies the risks the population is being asked to take: receiving vaccines, and perhaps experimental adjuvants, which their manufacturers have been encouraged not to test, with no prospect of compensation for illness or death that might result.


Posted by Meryl Nass, M.D. at 11:43 AM

ejnews: 最近一寸色々ありましてニュースの翻訳をする時間が取れなくなっています。私がアメリカに漂着したのはコロンブスが新大陸を発見したと主張した数年後でありまして..............................冗談です。


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