A Merry Christmas for Pharma; a stocking full of coal for Americans
A Merry Christmas and Happy New Year for Pharmaceutical Manufactures; a stocking full of coal for Americans
The recurring theme of legislation during 2005 can be summed up as “immunity from liability”. One staggering proposal after another has sought to protect the interests of the most politically powerful and influential industries from legal accountability when Americans are harmed, typically to the benefit of large oil companies and pharmaceutical and/or medical device manufactures.
Continuing the theme in a late night, pre-Christmas flurry, House and Senate leaders passed liability protection language laced into a Department of Defense spending bill protecting vaccine manufacturers from any and all liability from harm caused by rushed and untested, experimental vaccines during wartime or an epidemic, such as the bird flu.
Such protection against vaccine liability sets in motion a landslide of negative and potentially critical outcomes for consumers; harmful and costly adverse effects that may continue to surface for decades.
Without financial and punitive accountability for injuries resulting from unsafe drugs, manufactures have no reason to safeguard the public against adverse reactions that could cause secondary or life-threatening illness or disease. Instead, they stand to gain by the sale of added drugs to combat the newly created medical crisis.
Without the risk of liability, there is no inherent need to spend additional funds to ensure the safety of the manufacturing process itself, perform critical follow-up studies and clinical trials with diverse patient controls.
Laws that protect powerful special-interest groups from liability can only prevail if American’s remain idle and silent in their wake.
Without the risk of liability, the financial loss to a family or individual harmed by a vaccine, whether crippling or fatal, will be enormous with no legal recourse to seek damages. Any ongoing or life-long medical or special-care needs will become a financial burden that the individual or family must bear alone.
In a climate for which there is no accountability, no liability concerns and no risk to reputation, companies are compelled to take dangerous shortcuts that positively benefit the investment of stockholders without regard for the safety of the public. They become instruments of deceit and under the Bush administration’s plan, are paid for the privilege.
Without fear of liability and legal recourse for injured consumers, manufacturers of drugs become the sole guardians over the number of deaths and injuries that are acceptable in the course of producing and administering new drugs and vaccines; the sole proprietors over the risk-to-benefit ratio (deaths Vs lives saved) that meets both demand and profit margins.
Are these concerns simply pie in the sky? Consider the contamination found in the entire year’s supply of flu vaccine manufactured by Chiron in 2004 that created massive shortages throughout the United States. Fear of a flu epidemic was heightened as long lines formed in neighborhood drug stores, clinics and hospitals while staff attempted to manage the crowds and asked that those most at risk be given first priority.
Had Chiron been operating under today’s gift of guaranteed immunity from liability, would they have come forward and publicly disclosed the contamination and faced the loss of reputation and revenue, or would they have continued distribution of the vaccine to the American public who would have shouldered the risk of injury in mass proportions? Under the new law, even if you could prove that Chiron knowingly committed such an atrocity, your right to seek damages has been stripped.
Americans have every reason to be outraged and need not go any further than the FDA’s own website for examples as to why the pharmaceutical industry cannot be entrusted to protect consumers, whether the drug being manufactured is a vaccine to fight a potential pandemic or otherwise.
As recently as July of 2005, Merck & Co. (makers of Vioxx) received a stern warning letter from the FDA for illegally changing their manufacturing process of a drug used to treat Leukemia. The letter cites, “Failure to submit a supplement for a change in the production process and quality controls that has a substantial potential to have an adverse effect on the identity, strength, quality, purity or potency of the product.”
Of major concern regarding the safety of the bird flu vaccine itself is the planned use of MF59 (a vaccine additive to increase effectiveness) by Chiron. MF59’s primary ingredient, Squalene, is listed as one of the potential causes of debilitating illnesses, including ALS (Lou Gehrig’s Disease) prevalent among Gulf War veterans following mandatory immunizations.
Additionally, recent reports have exposed the Pentagon for concealing from Congress the fact that multiple deaths and more than 20,700 hospitalizations of soldiers occurred after being given the anthrax vaccine during the mandated program that began in 1998, later changed to voluntary administration.
As the Bush administration prepares to reinstate mandatory anthrax vaccination for military personnel with the added insult of liability immunity for vaccine manufactures, veterans groups and family advocates for soldiers have taken out full-page newspaper ads denouncing the move.
Laws that provide immunity from liability strip American’s of their constitutional right to accuse and hold accountable those who have harmed them in a court of law. It is a constitutional right that was provided for to ensure that the rights of an individual were guarded against harm from the large and powerful.
Laws that protect powerful special-interest groups from liability can only prevail if American’s remain idle and silent in their wake. Your representatives must be held accountable for placing you and your loved ones at risk. Congress must hear the decent of Americans and return the courts to those who have an earned steak in our democracy.
Cliff Horwitz welcomes your comments regarding this article and can be reached by calling, (312) 372-8822, or email