Archive for the ‘Product Safety’ Category

Co-authored by Anthony So, professor of the practice of public policy and global health, director, program on global health and technology access at Duke University

The World Health Organization’s Director-General recently warned of the growing challenge of antibiotic resistance in the starkest terms: “A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill.” In the case of tuberculosis, many infections are already resistant to first-line therapy, and second-line therapy costs between 50 and 200 times more. For methicillin-resistant Staphylococcus aureus (MRSA), an antibiotic-resistant infection that claims more lives than AIDS in the U.S. each year, the costs of these infections to hospitals may reach as high as $4 billion annually.

Responding to this challenge, existing antibiotics must be conserved and novel antibiotics developed. To preserve the effectiveness of antibiotics for human use, Europe banned feeding antibiotics to livestock for growth promotion in 2006. In Denmark, where such use of antibiotics had been phased out more than a decade ago, drug-resistant pathogens in livestock are down while industry output is up. Yet a bill to restrict such use here — The Preservation of Antibiotics for Medical Treatment Act — languishes in the U.S. Congress.

Instead, the Generating Antibiotic Incentives Now, or GAIN, Act has piggybacked into the FDA bill reauthorizing user fees for drug approval. GAIN would provide five more years of monopoly protections for new antibiotics. Already receiving three to seven years of exclusivity, some antibiotics may receive up to 10 years of protection after market approval. This measure defies both the economics and biology of antibiotic resistance.

Resistance to an antibiotic increases as the drug is used more frequently, so the use of new antibiotics must be reserved for resistant infections. However, monopoly protections conflict with the need for preservation by encouraging companies to sell as much of the new drug as possible. Further, this incentive does little to defray the upfront costs of R&D but risks imposing a heavy cost on consumers, both here and abroad. Rationing antibiotics by monopoly pricing will not ensure appropriate use by doctors or patients. Lengthening the monopoly period will not lead to firms forfeiting today’s profit for preserving tomorrow’s antibiotic effectiveness. In fact, the same drug companies do not even reserve classes of antibiotics important for treating human disease from non-therapeutic use in growth promotion in animals. And there is no profit from drugs kept in reserve.

Multiple drugs used in combination are the mainstay of treatment for diseases like tuberculosis. Yet extended exclusivity may thwart the innovation and access to such combination therapy. Consider the lessons from Abbott’s hold over ritonavir, a drug that boosts the effectiveness of other HIV drugs used in combination. In 2003, Abbott hiked the price of ritonavir by 400 percent — except when used for its own combination product, Kaletra — placing other combination treatments relying on this booster drug at a market disadvantage. So does this incentive approach lead to GAIN — or just greed?

Worse yet, the bill fails to address the serious scientific bottlenecks in the pipeline. The customary approaches to identify novel drug candidates have produced dismal results. The experience of a leading drug company suggests that it would take 80 times the number of screens of potential drug compounds to yield one antibiotic launch compared to one drug launch in other therapeutic areas. Throwing just any incentives at antibiotic R&D is not going to work. The solution to the faltering antibiotic pipeline is not an extra dose of data exclusivity.

We need to get back to the basics — the 3Rs — sharing resources, risks and rewards. Greater public support for new models of R&D collaboration would help share resources and risks with the private sector. Bolstering such efforts, like those at NIH’s National Center for Advancing Translational Sciences, might help lower the barriers to bringing forward new antibiotics to clinical trials. One method of sharing rewards — offering prizes — could enable companies to recuperate their R&D investments without relying just on revenues from the quantity of antibiotics sold.

In these austere economic times, where might such monies come? Leading all sectors in defrauding the federal government under the False Claims Act, the pharmaceutical industry has paid $23 billion in settlements and fines to federal and state governments over the past two decades, some portion of which might have been directed to a foundation that would support innovation and access to such life-saving medicines.

The failure to find suitable incentives reflects a poverty of policy imagination. The greatest cost, though, may be the complacency that comes with believing that Congress addressed antibiotic resistance with this measure. Even with the GAIN Act’s passage, this public health challenge will still remain: Tomorrow’s infections will not be cured with this expensive placebo.

For more by Robert Weissman, click here.

For more by Anthony So, click here.

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"Christine Hines"Public Citizen recently joined with other consumer and patient groups in a letter urging the U.S. Food and Drug Administration to ban phthalates from drugs and biologic products.

Phthalates are a family of chemicals known as “plasticizers” that are used in consumer and pharmaceutical products. For example, they are used to soften plastics – like those used in products such as baby teething rings and pacifiers. These chemicals, including dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP), have been linked to cancer, as well as developmental and reproductive defects.

Phthalates are being phased out of consumer products – a 2008 federal law banned these phthalates in children’s products. The European Commission and the Environmental Protection Agency also have noted the health risks of the chemicals.  The EPA said it is concerned about phthalates because of “their toxicity and the evidence of pervasive human and environmental exposure to these chemicals.”

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Earlier this year, Newark Mayor Cory Booker excitedly announced the launch of a new partnership between Let’s Move! Newark and Nestlé to address the obesity problem facing the children of Newark.

Kit Kat: Nestle's "health food" - flickr photo by Howard Lake

Nestle's "health food" - flickr photo by Howard Lake

“This is an amazing day in the city of Newark!” Booker exclaimed. Amazing, indeed. It’s amazing that Newark is partnering with a giant candy bar and infant formula corporation to conquer health problems that the company itself plays a role in perpetuating. A press release announced that Nestlé had helped to devise a nutritional education curriculum for Newark families highlighting “the importance of breastfeeding, increasing fruit and vegetable consumption, healthy snacking, dealing with a fussy eater, portion control and physical activity.”  The program draws on “the nutritional expertise of Gerber,” Nestlé’s infant formula brand.

But why would a company that depends for its profits on women not breastfeeding and families purchasing candy (not fruits and vegetables) be an ideal source of nutritional expertise?

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This week, we’ve got our eyes on Congress, Wall Street, the “#1 Corporate Power Tool,” school districts and more!"Public Citizen Lady Liberty"

For better or worse, Washington D.C. is a city of awash with acronyms. And this week, there are a few capital letters that the medical device industry would rather you not pay any attention to: MDUFA. Literally, MDUFA stands for Medical Device User Fee and Modernization Act, but in actuality these letters simply mean danger for consumers.  A lot of the coverage of MDUFA has focused on the prescription drug aspect. However, the story is about more than drugs. Medical device safety is at a crossroads, and Congress could really mess things up. Here is where MDUFA stands now.  We recently wrote a report, which documented the average number of high-risk recalls of medical devices in 2011 was more than double than in recent years. We also documented the keen interest the medical device industry seemed to have in weakening already lax regulations. This week Congress will vote on MDUFA and we urge them to put patient safety ahead of corporate profit.

Today, amid the news coverage of JPMorgan Chase’s $2 billion loss in derivatives bets, Public Citizen published a report, many weeks in the making, that expounds on the historical lessons of derivatives deregulation and the urgency to implement the rules called for in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. Read a copy of the press release which links to the report entitled: “Forgotten Lessons of Deregulation: Rolling Back Dodd-Frank’s Derivatives Rules Would Repeat a Mistake that Led to the Financial Crisis.” The report explains how America’s top financial policymakers deregulated the financial derivatives market in the 1990s and provides a detailed account of how deregulation led to the ensuing housing bubble, financial crisis and Great Recession.

The report comes as members of Congress have introduced nine bills that would weaken the derivatives provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010.

All seven bills moving in the U.S. House of Representatives have been approved by committees, and three have passed the full House. Two bills that would exempt overseas transactions from Dodd-Frank’s derivatives provisions may be voted on as soon as Thursday in the House Agriculture Committee. Other bills would exempt trades by supposedly “small” players, reduce transparency requirements and strike down a provision to ban derivatives trading by federally insured banks. At least three other bills would impose impediments for agencies to promulgate rules concerning financial services in general.

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House Republicans in two different committees yesterday approved a malpractice liability bill, H.R. 5 – again. H.R. 5, a proposal that aims to limit the liability of the health industry and leave injured patients without an adequate avenue for redress, previously passed the full House in March.  This time, lawmakers on the House Energy & Commerce and Judiciary Committees presented the proposal as a fix to the nation’s budget.  Nothing could be further from the truth.

The bill, as we’ve repeatedly said, remains an expensive proposal that will cost lives and money while shielding the entire medical industry – drug and device manufacturers, hospitals, doctors, and nursing homes – from its own reckless conduct.

By restricting patients’ access to court, H.R. 5 will force medical malpractice victims and their families to turn to public, taxpayer-funded programs such as Medicare and Medicaid, and disability benefits for medical care and other financial assistance, because the negligent wrongdoers would be shielded from liability.

This unintended consequence would increase health care costs.

If nothing else, the House majority should pay attention to the money wasted when patients are unnecessarily injured by egregious medical errors or defective medical products. The Department of Health and Human Services pays $4.4 billion a year for the consequences of medical errors.

Some conservatives have even cautioned lawmakers about the bill’s effect on state laws. For decades, states have written their own laws for deciding negligence cases, including medical malpractice claims. A one-size-fits-all-policy on a traditionally state matter would wreak havoc on state laws.

Despite the numerous concerns and calls to drop this bill, the House majority’s ill-conceived and inaptly-named proposal – the Help Efficient, Accessible, Low-Cost, Timely, Healthcare Act – is expected to go up for another House floor vote. (You may wonder why there would be a second House vote on the same bill; this time, it is included in the FY2013 budget reconciliation recommendations, which it what both committees marked up yesterday.)

Indeed, it may fly through the House yet again, but we will have to rally the Senate to turn its back on this shameless and dangerous gift to industry.

Christine Hines is Public Citizen’s consumer and civil justice legal counsel.

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