Archive for the ‘Product Safety’ Category

By Robert Craycraft

Asbestos was once used as a flame-retardant and for electrical insulation in buildings, ships and homes. Before it was discovered to cause cancer, millions of American workers and veterans handled and were otherwise exposed to deadly asbestos fibers.

An unknown amount of the hazardous material is still present in our communities. The Centers for Disease Control and Prevention report that roughly 3,000 people continue to die from mesothelioma and asbestosis every year; some experts estimate the death toll is as high as 10,000 annually when other types of asbestos-linked diseases and cancers are included.

In early February, the U.S. House of Representatives Judiciary Committee Subcommittee on Regulatory Reform, Commercial, and Antitrust Law held a hearing on H.R. 526, the Furthering Asbestos Claim Transparency Act (or FACT Act). Generally speaking, the more transparency the better. However, in this case, the asbestos industry is using the guise of “transparency” to push the FACT Act as a way to delay compensation to asbestos victims and their families. The bill would require the trusts that manage victim compensation to retroactively compile information on all claims they’ve paid and to require the trusts to answer any and all information requests by asbestos company defendants.

These paperwork requirements could have the effect of slowing or even stopping the important work of the trusts to compensate victims that have developed deadly diseases like mesothelioma due to exposure to asbestos. Rep. Hank Johnson (D-Ga.) called the FACT Act a “Trojan horse” which “guarantees that the insurance companies pay as little as possible.”

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As a general rule, cost-benefit analyses are suspect.

Such analyses – which federal agencies perform to weigh the health and safety “benefits” of regulations (benefits like lower infant mortality rates and reliably safe and clean drinking water) against the “cost” of lost profits to Corporate America – result in a distorted model of a regulation’s impact. Invariably, the distortion creates a bias that exaggerates the regulation’s “cost,” largely because cost (measured in dollars and cents) is more easily quantified than benefits.

So one might think it’s a good thing that economists at the FDA have started factoring in pleasure – or, more specifically, its loss – when weighing the costs and benefits of new regulations. And one might think that a regulation that is expected to result in lower infant mortality rates, fewer cancer diagnoses, and longer, healthier lives for the American public to be a winner in terms of “pleasure,” right?

Unfortunately, one would be wrong.

Shockingly, the FDA’s cost-benefit analysis for a new tobacco regulation resulted in the rule’s projected health and safety benefits – fewer instances of heart and lung disease and fewer early deaths – being reduced by 70 percent due to the “loss in pleasure” smokers endure when trying to break their addiction.

As an ex-smoker myself (tobacco-free since 2008), I am well aware that the symptoms of nicotine withdrawal certainly constitute a “loss in pleasure.” But the notion that a smoker’s physical discomfort for a relatively brief period of time somehow trumps by 70 percent the health benefits of quitting (not to mention the increase in one’s disposable income and the gradual restoration of one’s senses of taste and smell) is utterly outrageous.

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In the aftermath of the tragic deaths associated with General Motors’ faulty ignition switches, two questions present themselves:

1. How can we save lives by stopping corporations from ever again suppressing life-saving information about dangerous products?

2. How can we hold corporate bosses accountable for suppressing life-saving information?

Last week, activists tuned in to an online conversation about reforms Public Citizen is advocating that will answer these questions and how to support those reforms by calling your members of Congress.

Miss the webinar? Catch up by watching the video below:

To make sure you’re invited to the next live online discussion, sign up today.

Rick Claypool is the online director for Public Citizen’s Congress Watch division. Follow him on Twitter at @RickClaypool.

Finally, we can strike one off our list. We can remove big corporate food manufacturer General Mills from Public Citizen’s Forced Arbitration Rogues Gallery, an unofficial catalogue of some of the many corporations that use their fine-print contracts to deprive consumers of the right to sue, forcing them instead to resolve disputes in individual, secret arbitration.

Removing General Mills from the “Rogues Gallery” is the least we can do now that the cereal and snack maker has itself deleted the hideous “you can’t sue us for harm we cause” language from the legal terms of its website.

General Mills recently had added a forced arbitration clause to its “legal terms” on its website and prohibited class actions in its terms of service for the same reasons as most other corporations – to unilaterally deprive its customers from filing lawsuits against it and escape responsibility for causing injury.  The reason behind General Mills’ move to reverse its ill-fated decision is awe-inspiring: it’s the people!

Lesson Number One for corporate lawyers and public relations spokespersons – American consumers would like to retain their legal rights, thank you very much.

After an article in The New York Times exposed General Mills offensive terms, the people reacted, and quickly.

@Slate (Apr 19): “Why people are freaking out over General Mills’ new legal policy: http://slate.me/1haFUIo  pic.twitter.com/hcDvkNm6JN

‏@Wonkette‬ (Apr 17‬): “You Can No Longer Sue General Mills Even If They Serve You A Big Bowl Of E Coli http://bit.ly/1iud62l” ‬

Three days after The New York Times piece was published, General Mills recanted.

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The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable.

The steroid injections, distributed by the New England Compounding Center in Framingham, Mass., have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New England Compounding Center.

The large-scale production of a drug — in this case, a drug that is intended to be sterile and injected into patients — appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce.

Indeed, prior warning letters from the FDA to the New England Compounding Center and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients. By not aggressively enforcing regulations related to drug manufacturing by compounding pharmacies, the FDA has perpetuated a double standard: Traditional drug manufacturers must adhere to rigorous drug-safety standards intended, for example, to prevent the contamination of their products. But so-called compounding pharmacies engaging in large-scale drug production do not. This double standard has resulted in the unfolding public health catastrophe involving hundreds and potentially thousands of patients who received steroid injections for back pain.

Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible. If current statutes and regulations provided the FDA with authority to prevent this disaster, senior FDA officials should be held accountable. If holes in the agency’s existing legal authority are identified, Congress should act immediately to pass legislation to remedy the situation.

Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group

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