Archive for April 29th, 2010

Public Citizen has been concerned about the heart dangers caused by the diebetes drug Avandia for a decade. But to add insult to injury, the makers of the drug are also now involved in an international unethical study involving it. If that weren’t bad enough, this study was ordered by the FDA. What?! Something isn’t right here.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, testified on the Hill yesterday in a House appropriations subcommittee hearing on Avandia. He presented new data since we last urged the FDA in 2008 to remove Avandia from the market.

GlaxoSmithKline, Avandia’s manufacturer, pressed forward with the FDA-requested study, drawing a pool of 16,000 subjects from 14 countries. It pits the diabetes drug against its competitor, Actos, even though some FDA officials have called the trial “exploitive of patients.”

“Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage,” Wolfe told the lawmakers.

But FDA Commissioner Margaret Hamburg defended the study, as reported by the AP and picked up by Bloomberg BusinessWeek. Hopefully it won’t take until the end of the study in 2015 for someone to step in and protect these patients, who are suffering from type 2 diabetes without knowing that their so-called treatment could be causing them further harm.

Weissman

Now that the Kabuki dance is finally over and the financial reform bill is moving to the Senate floor, attention can be turned to the real issue: Will the new rules rein in Wall Street? The key issue is not whether the financial regulatory bill is going to pass but whether it will be strengthened.

The Senate banking committee bill contains a wide range of important reforms that should be enacted quickly, but the bill also must be strengthened considerably to establish a framework to prevent a recurrence of the financial crisis.

Here are five priorities as the debate goes forward:

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Holman

The DISCLOSE ACT is a straightforward legislative response to a gravely damaging Supreme Court decision allowing unlimited corporate spending in elections. Far from revolutionary in scope, the DISCLOSE Act provides transparency and accountability in political spending, giving voters a valuable means to discern who are the interests that fund campaign ads.

It is unpredictable how much corporate money will flood into elections in our new unregulated system, but it is reasonable to assume it will be very substantial indeed – and possibly overwhelming in selected candidate races of particular interest to a major corporation.

Even before a single dollar is spent, the threat of corporate spending in elections wields significant influence over policymakers. Imagine the enormous political pressures business lobbyists can now place on Congress as it attempts to grapple with the major economic issues of the day, with the looming prospect of being punished or rewarded through direct campaign spending by the companies subject to the regulations. Corporate influence will reach to virtually all major policies – on financial services, health care reform, climate change, trade – everything. The public, minus the enormous wealth available to corporations, will be further shut out of its own government.

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Yesterday, in honor of Workers’ Memorial Day, President Obama for the first time issued a proclamation observing the day.  Workers’ Memorial Day commemorates the establishment of the Occupational Safety and Health Administration (OSHA), which is charged with protecting workers from safety and health hazards.

Several recent tragedies have drawn significant attention to workplace safety.  On April 5, there was an explosion at the Upper Big Branch mine in West Virginia that killed 29 miners.  And last week, an explosion on an offshore oil rig in the Gulf Coast off Louisiana, in which 11 workers are missing and presumed dead.

In testimony before the Senate Committee on Health, Education, Labor and Pensions, United Mine Workers President Cecil Roberts said that Massey Energy, the mine company that owned the Upper Big Branch mine, is “run like it was 1921.” The mine operator had been cited nearly 500 times in 2009 for violations of the Mine Safety and Health Act.  But despite being shut down 61 times since the beginning of 2009, the dangerous conditions at the mine were allowed to continue.

Improvements are needed to both the Mine Act and the Occupational Safety and Health Act (OSH Act).  In 2008, the House passed the Supplemental Mine Improvement and New Emergency Response Act (S-MINER) Act, but it was not taken up in the Senate.  The S-MINER Act would have increased penalties and given the Mine Safety and Health Administration (MSHA) increased authority to shut down mines with a pattern of violations. But there are other problems the S-MINER Act would not address.  One of these problems is the backlog of 16,000 contested citations.

The OSH Act is also woefully out of date.  In a hearing in the House Subcommittee on Workforce Protections, witnesses discussed the need to update whistleblower protections contained in the Act.  The Protecting America’s Workers Act would upgrade these protections and establish other needed reforms to OSHA.

Lena Pons is a policy analyst at Public Citizen.

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