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By David Michaels
All of a sudden, America has become acutely aware of the terrible lung disease caused by workplace exposure to artificial butter flavor. Last week, the failure of OSHA to do anything in response to the outbreak of cases across the country was the subject of several powerful newspaper articles (including a front page story and editorial in the New York Times) and hearings in the House and Senate. In addition, the obstructive lung disease cases in the flavor industry were discussed in an alarming article in CDC’s Morbidity and Mortality Weekly Report. The article reported that
Bronchiolitis obliterans has been identified in microwave-popcorn workers in several states, including Missouri, Iowa, Ohio, New Jersey, and Illinois; bronchiolitis obliterans in flavor-manufacturing workers has been identified in Ohio, California, Maryland, and New Jersey.
No doubt prompted by all the unwanted publicity, OSHA has announced a National Emphasis Program, finally promising to inspect microwave popcorn plants. To me, this is little more than a half-hearted attempt to make OSHA look busy, since NIOSH has been focused on the hazards in microwave popcorn production for the last six years. If OSHA really wanted to inspect factories with dangerous exposures and sick workers, they would start at the factories where flavors are manufactured and mixed, then visit the plants where diacetyl-containing snack foods like Twinkies are made.
A colleague who has been following the developments in the artificial butter flavor debacle sent me a note, underscoring just why OSHA’s emphasis program misses the boat: Read the rest of this entry »
By David Michaels
Following up on a powerful indictment of OSHA’s failure to protect workers from diacetyl and other hazards published two days ago in the New York Times, today’s edition of the newspaper has a scathing editorial on the demise of OSHA under the Bush Administration. The editorial writers particularly go after OSHA Assistant Secretary Edwin Foulke, whom they refer to as “one of the most zealous of the antiregulatory ideologues.”
The problem goes beyond the actions (or inactions) of one anti-regulatory zealot – OSHA has been beaten down and handcuffed for so long, even well-meaning regulators would have trouble getting the agency to work well.
Celeste Monforton and I first identified the failure of OSHA to do anything about flavoring workers’ lung disease and FOIA’d the documents cited by the Times in 2004, long before Mr. Foulke came to OSHA. We first wrote about OSHA’s lack of response in an academic paper we published two years ago. Unfortunately, we entitled the paper “Scientific evidence in the regulatory system: Manufacturing uncertainty and the demise of the formal regulatory system,” (PDF here) and it was widely ignored until recently, perhaps because it had such a boring title. Since then, we’ve posted a tremendous amount of material up on SKAPP’s website, using diacetyl as a case study in regulatory failure.
Its very gratifying to see that a national discussion devoted to examining the crisis we identified and have been compiling information about.
Here’s the full text of the New York Times editorial:
Did you know that Wednesday was World Malaria Day? Farzaneh and Aman at Technology, Health & Development marked the occasion with posts about initiatives that are tackling the disease, while Merrill Goozner at GoozNews wonders why the World Banks seems to lack a sense of urgency on the issue.
Regular ScienceBlogs readers probably noticed that bloggers’ use of charts from scientific journals, and the larger issue of open scientific discourse, was a hot topic this week. It all started when Shelley Batts of Retrospectacle put up an informative post about a study recently published in the Journal of the Science of Food and Agriculture regarding alcohol’s effect on berries’ antioxidant activity. She included a chart and graph from the published results in her post, and soon received a threat of legal action from the journal’s publishers if she didn’t take them down. Bloggers were eloquent in their outrage; check the comments on this post for links to other bloggers’ reactions, or see the extensive list of links compiled by Coturnix at A Blog Around the Clock. Shelley soon received an email from the journal’s publisher apologizing for any misunderstanding, and stating that they would typically grant permissionon request and did not see a need to pursue the matter further.
Below the fold, there’s more on global health, environmental topics, and U.S. politics.
By David Michaels
On April 26, 2002, exactly five years ago today, the Centers for Disease Control (CDC) published a report about the risk of a terrible and sometime fatal lung disease, bronchiolitis obliterans, in microwave popcorn workers. The report appeared in the CDC’s widely-disseminated Morbidity and Mortality Weekly Report.
Since then, dozens of workers at factories where artificial butter flavors are produced, mixed or applied have become sick, and at least three workers have died. Others are awaiting lung transplants.
By coincidence, today CDC has issued a new report in MMWR about bronchiolitis obliterans among workers in the flavoring industry.
In a year-long investigation that involved more than 100 Freedom of Information Act requests to EPA, the Center for Public Integrity discovered that Superfund site cleanups are being started and completed more slowly than in the past; that the reimbursements the Superfund program is getting back from companies for cleanups has steadily declined; and that a lack of funds has delayed needed work at some hazardous sites.
Superfund sites are areas that companies or government entities have moved away from, leaving hazardous materials behind. The Superfund program was initiated in 1980 to “locate, investigate, and clean up the worst sites nationwide.” U.S. residents should care about this program because, the Center’s analysis found, nearly half of the U.S. population lives within ten miles of one of the 1,304 active and proposed Superfund sites listed by the Environmental Protection Agency.
There are 114 sites whose neighbors might find this report particularly worrisome. The Center’s Alex Knott explains:
OSHA’s failure to keep up with today’s workplace hazards is the subject of two Congressional hearings and one New York Times article this week (see our post on the topic, too). Senator Kennedy is set to introduce new legislation, called the Protect America’s Workers Act, tomorrow; earlier this week, Senator Patty Murray held a hearing and introduced a bill on domestic violence in the workplace.
Also on the subject of workplace hazards and Capitol Hill, the Asbestos Disease Awareness Organization has posted a short video featuring John Thayer, supervisor of the crew of workers who were exposed to asbestos for years while working in the tunnels under the U.S. Capitol. (Also see an earlier Washington Post article published after Thayer testified at a hearing in which Patty Murray introduced a bill to ban asbestos in the U.S.)
In other news:
By David Michaels
On the front page of today’s New York Times, reporter Stephen Labaton highlights a trend that we’ve been writing about here at The Pump Handle for some time: Occupational Safety and Health Administration has delayed or halted work on important standards for worker protection and put more of its energies into voluntary programs that let employers decide how far they’re willing to go to protect workers’ health and lives.
Labaton’s article focuses on OSHA’s failure to protect workers from diacetyl, an artificial butter flavoring that numerous scientific studies have linked to the lung disease bronchiolitis obliterans. Much of the material he presented comes from the case study on flavor worker’s lung disease as an example of regulatory failure, posted at www.DefendingScience.org, the website of the Project on Scientific Knowledge and Public Policy (SKAPP). Read the rest of this entry »
By Lee Friedman
The Survey of Occupational Injuries and Illnesses (SOII), based on OSHA logs, indicates that occupational injuries and illnesses in the U.S. have steadily declined by 35.8% between 1992-2003. However, major changes to the OSHA recordkeeping standard occurred in 1995 and 2001. A recent study we published illustrates that the steep decline in reported occupational injuries and illnesses during the past 10 years in the U.S. workforce is an artifact resulting from changes to the recordkeeping rules and regulations
rather than an improvement in workplace safety. Read the rest of this entry »
By David Michaels
As regular readers of this blog know, worker health advocates have been pushing for regulation of diacetyl, an artificial butter flavoring chemical that’s been linked to bronchiolitis obliterans, a terrible, sometimes fatal lung disease.
Today, in anticipation of two Congressional hearings and a major newspaper article due out tomorrow, OSHA has announced that it will take its first steps to protect diacetyl-exposed workers. Unfortunately, OSHA has announced it will ignore thousands of workplaces where workers are being exposed with no protection, and will focus only on microwave popcorn factories, the one set of workplaces where NIOSH has already been helping employers address the problem. So when OSHA inspectors go out, they will likely find the problem under control in the popcorn factories. And more workers in the remainder of the food industry will get sick.
When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allowed to negotiate with the DMV as to how the agency will use your fee? Of course not. So why is the drug industry allowed to negotiate with the FDA about how the agency will use the money it collects in fees paid for new drug applications?
We’ve written several posts already about the Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products. (Go here for a list of past PDUFA posts, or check out the new white paper on PDUFA here.) We and many other members of the medical and public health have raised concerns about impact of PDUFA on drug safety; Christopher Moraff summarized them neatly in a recent American Prospect article:
User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug’s approval — the equivalent, according to one former chief editor of The New England Journal of Medicine, of “putting the fox in the chicken coop.”
So, who does support the user fee system? None of the usual suspects, it turns out.
Read the rest of this entry »
Two congressional committees, one in the House the other in the Senate will hold oversight hearings this week on OSHA. The timing is quite fitting: Saturday, April 28 is Worker Memorial Day.
On Tuesday, April 24, the Subcommittee on Workforce Protections of the House Education and Labor Committee’s hearing ”Have OSHA Standards Kept Up with Workplace Hazards?” will feature testimony from OSHA Assistant Secretary Edwin Foulke. On Thursday, April 26, the Senate Subcommittee on Employment and Workplace Safety will conduct a hearing entitled “Is OSHA Working for Working People?” Read the rest of this entry »
Tammy has posted another edition of the Weekly Toll: Death in the American Workplace at her Weekly Toll blog. It gives short writeups on 117 workplace deaths, including the following:
- Vernon Christensen, a 72-year-old resident of Stayton, Oregon, was crushed by a reversing logging truck while working as a flagger on a logging road.
- Lina Shearer, a 43-year-old resident of Clay City, Kentucky, was killed when a piece of machinery broke in the manufacturing plant where she worked and struck her in the neck.
- Lt. Corey Dahlem, a 45-year-old police officer from Gainesville, Florida, died after being struck by a drunk driver while on duty after the University of Florida men’s basketball team won the national title.
Read the full descriptions of these and other workplace deaths here. It’s an excellent reminder of how much work we still have to do on occupational health and safety.
By David Michaels
In the U.S., we see an average of one gun-related homicide every 45 minutes, or 32 each day.* These are usually treated as isolated incidents, until a horrific event like the Virginia Tech massacre reawakens the public and strengthens public health advocates who are attempting to prevent gun violence.
That’s what has just happened in Georgia. There, legislation that would allow employees to keep guns in workplace parking lots went down to an unpredicted defeat. Of course, the National Rifle Association “never stopped arm-twisting Georgia lawmakers,” an Atlanta Journal-Constitution editorial reports. Lyle V. Harris, for the editorial board, writes:
The FDA certainly wasn’t the biggest newsmaker this week, but it did create some buzz in the blogosphere – mostly due to the Prescription Drug User Fee Act, or PDUFA, which is up for Congressional reauthorization. Matt Madia at Reg Watch and Merrill Goozner at GoozNews are tracking PDUFA’s progress through the Senate. Corpus Callosum has three posts on three New England Journal of Medicine editorials about PDUFA (here, here, and here). (We’ve got Susan Wood’s take on the editorials here; or, check out all our PDUFA posts here.) The Olive Ridley Crawl reports that proposed restrictions on new-drug advertising are meeting fierce resistance. Cervantes at Stayin’ Alive point to another article in NEJM, this one about the antibiotic Ketek, which the FDA approved despite safety concerns. Meanwhile, Mike the Mad Biologist looks at E. coli and the inadequacy of funding for FDA’s food inspection work.
Elsewhere in the blogosphere …
By David Michaels
An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies.
One recent case of such data being kept secret, which Nature reporter Jim Giles covers in an accompanying article, is Eli Lilly’s schizophrenia drug Zyprexa. David Egilman, a physician who had access to confidential documents about Zyprexa’s dangers, is being threatened with jail time for his role in the release of the papers to, among others, New York Times reporter Alex Berenson. The story Berenson broke was front page news:
Among the victims of the tragedy at Virginia Tech were five faculty members:
James Bishop
Jocelyne Couture-Nowak
Kevin Granata
Liviu Librescu
G.V. Loganathan
Librescu was a 76 year-old Holocaust survivor who blocked his classroom doorway from the gunman while his students leapt to freedom.
The Roanoke Times has profiles of all the victims here.
By David Michaels
The controversy continues over NIH’s review of Bisphenol A (BPA), and the agency’s firing of Sciences International. Members of the NIH’s BPA Expert Panel have joined the discussion, through comments to the Pump Handle, assuring the public that their work was not not influenced by any potential conflicts.
In addition, today’s Washington Post and Los Angeles Times both have articles with additional details on the conflicts of interest that triggered the firing, along with comments on the process to date. There is also an interview with a panel member defending the quality of Sciences International’s work.
And a member of the Expert Panel has written a letter to the Post, with a copy to the Pump Handle, clarifying what he believes are mistakes in the Post’s coverage.
By Dick Clapp
Opponents in the debate over conflict of interest in cancer research are duking it out, and the current forum for their fight is the American Journal of Industrial Medicine. The article that touched off this particular scuffle was “Secret Ties to Industry and Conflicting Interests in Cancer Research,” by Hardell L, et al. (Am J Ind Med 2007;50:227-233), which details a number of examples of researchers working for industries and not disclosing their ties. The most widely publicized revelations (see this Guardian story) were about Sir Richard Doll, one of the icons of 20th century epidemiology, and his consulting arrangement with Monsanto, Turner and Newall (a British asbestos manufacturer), the Chemical Manufacturers Association, ICI (a British producer of vinyl chloride), Dow Chemicals and others. Other sections of the Hardell, et al. paper discuss testimony and articles by Dimitrios Trichopoulos, Hans-Olov Adami, Dennis Paustenbach and Jack Mandel regarding dioxin, Joseph McLaughlin and John Boice regarding cell phones and other examples of apparently undisclosed conflicts of interest.
The original article is well worth a read, but the letters in response – published in AJIM’s March 2007 issue—are just as revealing in their own way.
By David Michaels
We’ve been wondering why the US Occupational Safety and Health Administration still hasn’t issued new rules reducing worker exposure to silica, beryllium, diacetyl and other well-documented but under-regulated hazards. Now we understand. OSHA is hard at work, using its limited resources to weaken existing standards.
OSHA has just issued a proposed rule modifying the rules that are supposed to protect workers engaged in the manufacture, storage, sale, transportation, handling, and use of explosives. This modification was done at request of the munitions industry, which appears to have gotten just what it wanted: OSHA estimates that the rule will save employers money because it will reduce numerous regulatory requirements, while imposing virtually no new ones. What it won’t do is significantly reduce the risk of injury and death among employees who work with explosives. Read the rest of this entry »
By David Michaels
The National Toxicology Program (NTP) has fired Sciences International. Last month, Marla Cone wrote in the Los Angeles Times about allegations that the consulting firm, hired by the NTP to run the Center for the Evaluation of Risks to Human Reproduction (CERHR), had significant conflict of interest. The allegation was that Sciences International also worked for manufacturers of Bisphenol A, or BPA, a controversial endocrine-disrupting chemical that CECHR was evaluating. (Jennifer Sass and Sarah Janssen of the Natural Resources Defense Council have post on the BPA evaluation here).
Now, Lyndsey Layton of the Washington Post reports that
At the same time it has been advising the federal government, Sciences International has been on the payroll of Dow Chemical, BASF, 3M and other companies that produce some of the chemicals under scrutiny. Read the rest of this entry »
By Susan Wood
Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation. The Senate will be “marking up” a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. The version of the bill that has been released is nearly 300 pages long, and so far only takes small steps toward strengthening the Kennedy-Enzi drug safety bill introduced earlier this year.
If you want to learn some of the basics linking user fees, the FDA budget and drug safety, we have just issued a white paper “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA budget, and Drug Safety Related?” This is not a position paper, but rather a brief overview of the history, legislation, connections and varying positions that are in play now as these legislative actions take place.
The first part of the current bill in the Senate is reauthorizing PDUFA for the next five years. As was written in our open letter to Congress last month, “User fees may appear to save the taxpayer money, but at an unacceptable cost to public health.”
One of the signers of this letter, Dr. Jerry Avorn, has an article today in the New England Journal of Medicine, entitled “Paying for Drug Approvals – Who’s Using Whom?” Today’s early release of three articles on FDA reform demonstrate the depth and breadth of need for change at the FDA. Former Commissioner Dr. Mark McClellan also has an article, as do Drs. Sean Hennesey and Brian Strom.
The owners-operators of the Kentucky Darby Mine No. 1, Ralph Napier, Connie G. Napier, and John D. North, were assessed a $336,000 penalty by the U.S. Mine Safety and Health Administration (MSHA) for violations related to the May 20, 2006 explosion and death of five coal miners. Press reports indicate that MSHA officials met for four hours yesterday with family members of the deceased miners, along with Paul Ledford, the only survivor from the crew, to discuss their investigation, findings and the citations issued to the mine operator. Read the rest of this entry »
By David Michaels
The federal regulatory system is in shambles. Regulated industries call the shots and career scientists are prohibited from pushing back. With the agencies in retreat, fear of litigation has become an increasingly important mechanism for discouraging bad corporate behavior. Now, “regulation by litigation” is under attack.
Following a Bush Administration edict, a Texas judge is about to dismiss 1,000 Vioxx cases because the FDA asserts that any warning label the agency has approved — no matter how faulty or inadequate — must be considered adequate warning of danger.
Over the last few years, the Bush Administration has been quietly pushing a policy that would bar law suits from injured people if the manufacturer followed the letter of the federal agency’s regulation. It doesn’t matter if the agency succumbed (as has been the case many times recently, and certainly is true in the Vioxx case) to corporate political clout and scientific shenanigans – if the manufacturer didn’t violate a regulation, no injured party can sue.
Revere at Effect Measure updates us on the medical community’s latest plea for Libya to release the six health care workers unjustly sentenced to death for “deliberately infecting” children with HIV, and links to Physicians for Human Rights’ campaign to get the U.S. government to exert more pressure on Libya to free the nurses and doctor. Time is running short: The Libyan Supreme Court may hear the health workers’ appeal as early as the end of the month.
The IPCC Working Group II published their “Summary for Policymakers” on the impacts of climate change, and reports surfaced about disagreements between the scientists who wrote the document and the government representatives who worked out the final text. Lisa Stiffler at Dateline Earth conducts a side-by-side comparison of early and final versions of the report; Mike Dunford at The Questionable Authority explains how facts ought to be used in such a document. Gavin at RealClimate illustrates how different members of the media approach the story by relating three different interviews he gave.
In other global warming news, Adam Browning at Gristmill explains how legislation for a “world-class solar program” made it through the Maryland legislature, and Kevin Grandia at DeSmogBlog reports that ExxonMobil has agreed to disclose its soft money donations following a shareholder proposal from the group As You Sow.
Elsewhere in the blogosphere …
By James Celenza
Driving a private car is probably a typical citizen’s most “polluting” daily activity, yet in many cases, individuals have few alternatives forms of transportation. Thus urban planning and smart growth are imperative.
– American Academy of Pediatrics Ambient Air Pollution: Health Hazards to Children
Public Transit is an Environmental Health Issue.
The built environment is a summarizing concept that links issues like housing, transportation, neighborhoods and jobs. Safe and efficient public transit is a key component of healthy environments. How so? Numerous studies implicate motor vehicle air pollution as a significant contributor to respiratory and cardiovascular disease, especially among children. Air pollution in Southern California communities had been shown to affect lung development, raise the risk of asthma, and increase school absences due to respiratory illnesses by the Children’s Health Study. The latest finding from the study team zeroes in on the impact of exposure to traffic-related pollutants and shows that kindergarten and first-grade students who lived near busy roads experienced a higher prevalence of asthma.
If you only read one article on the issue of occupational health and safety this week, make it Ray Ring’s “Disposable Workers of the Oil and Gas Fields,” published last week in High Country News. “The core of the story can be classified as straightforward investigative coup,” editor John Mecklin explains in an accompanying piece . “In six months of amassing documents, scouring lawsuits and prodding databases, Ring was able to map out the general scope of a little-noticed reality: Since the start of the second Bush presidency, as skyrocketing energy prices drove a wild increase in oil and gas drilling across the Interior West, the number of oil and gas workers killed in and around drill rigs also rose relentlessly.”
The story Ring tells is all too familiar: time pressures, old equipment, and exhausting work schedules are common. Safety agencies lack resources to monitor workplaces, and fines for violations — even when workers have died or been severely injured — are small. State laws make the companies virtually immune to lawsuits from victims or their families.
“As with the drilling boom, the boom in worker death played out in isolated rural landscapes most of America never sees, and so the dead have been largely invisible, three paragraphs of filler material in small-town newspapers,” Mecklin explains. By contrast, Ring creates vivid portraits of the workers and family members whose lives have been irreversibly altered by accidents in the oil and gas fields.
Ring’s work brings to mind that of another reporter who decided to investigate a string of workplace accidents in an region and an industry that are often neglected in national news.
By David Michaels
The Bush Administration has gone all out to make sure states play no role in setting health and safety standards. This is not surprising, of course, since many states are far more committed to health and safety protection than the folks who currently run the federal government. Yesterday I talked about California’s efforts to protect workers from diacetyl. Today’s example: chemical plant safety.
Some weeks ago, I wrote about how Vice President Cheney’s son-in-law Philip Perry orchestrated a backroom maneuver that cut EPA out of chemical plant safety. Perry made sure responsibility went to the Department of Homeland Security (DHS), which has neither the authority nor the commitment to do it right. An added bonus in the legislation Perry helped push through would allow DHS to pre-empt any state laws stronger than the weak rules DHS was likely to propose.
That wrong may soon be righted, but only if Congress can overcome some powerful opposition.
By David Michaels
Labor health advocates in California are supporting legislation banning diacetyl, the flavoring chemical implicated in numerous cases of bronchiolitis obliterans, a debilitating lung disease, among workers in the food industry. The ban may never occur, but by demanding it we are getting closer to protecting workers and the public from this very toxic material.
The threat of a ban has forced the food industry into an unusual position - industry representatives are now praising the California OSHA program, which is also moving to issue regulations limiting exposure to the deadly chemical but has no plans to ban it (to industry’s relief.)
Meanwhile, federal OSHA continues to do NOTHING. Perhaps the public health advocates here in the nation’s capital should follow California’s lead, and lobby for Congressional legislation banning diacetyl nationally. The food industry would immediately demand an OSHA standard, and we might finally see some movement at OSHA . Read the rest of this entry »
In continuation of the tradition begun at Jordan Barab’s Confined Space blog, Tammy has posted another edition of the Weekly Toll: Death in the American Workplace at her Weekly Toll blog. (It was posted on April 1; my apologies for not linking to it sooner.) It gives short writeups on 59 workplace deaths, including the following:
- Daniel Contreras, a 32-year-old construction worker from Oxnard, California, died when the trench he was working in collapsed.
- Jeffrey Lowenthal, 53, was fatally shot during a robbery in the Maywood, Illinois hardware store he managed.
- Anthony Shands, a 72-year-old resident of Gilmer, Texas, fell to his death from a 150-foot communications tower where he was connecting cables.
Read the full descriptions of these and other workplace deaths here. It’s an excellent reminder of how much work we still have to do on occupational health and safety.
The Supreme Court’s decision in Massachusetts v. EPA was big news this week; Justin Pidot at Gristmill takes an in-depth look at the ruling’s implications, while Kevin Grandia at DeSmogBlog scrutinizes the stances of the parties opposing it. Then, of course, there was Bush’s recess appointment of Susan Dudley to head the Office of Information and Regulatory Affairs, which Ian Hart at Integrity of Science describes as part of larger White House assault on science in policymaking.
At the state level, Lisa Stiffler at Dateline Earth notes that Washington State is the first in the nation to ban PBDEs in specific situations, and Josh Rosenau at Thoughts from Kansas describes one approach Kansans are taking to the water problems that plague the Western U.S.
In the medical community, mammograms are getting a lot of attention, and Orac at Respectful Insolence explores the complexity of early cancer detection (Part II here). The Institute of Medicine report on PEPFAR (the U.S. President’s Emergency Plan for AIDS Relief) is also causing a stir; Nandini Ooman and Michael Bernstein at Global Health Policy and Naina Dhingra at RH Reality Check highlight some of its findings and recommendations.
Elsewhere in the blogosphere …
When President Bush nominated Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA) last year, her nomination didn’t make it out of the Senate committee. (See Celeste Monforton’s post on Dudley’s underwhelming performance before the committee.) Yesterday, Bush avoided Senate opposition by giving Dudley a recess appointment.
As head of OIRA, Dudley will be able to block regulations proposed by government agencies — and since she thinks that markets do a better job of regulating than the government does, she’ll probably do a lot of blocking.
“Dudley’s record is one of anti-regulatory extremism,” said Rick Melberth, Director of Regulatory Policy at OMB Watch, which published a report last year entitled The Cost Is Too High: How Susan Dudley Threatens Public Protections. “She has opposed some of our nation’s most basic environmental, workplace safety and public health protections.” In an LA Times article, Joel Havemann describes some of Dudley’s anti-regulatory positions:
This week, health advocates are drawing attention to some important safety hazards.
The Senate just passed a resolution proclaiming the first week in April National Asbestos Awarenss Week and urging the Surgeon General, as a public health issue, to warn and educate people that asbestos exposure may be hazardous to their health. Meanwhile, EPA released a new pamphlet educating mechanics about how to minimize their asbestos exposure (many cars’ brake systems contain asbestos), and the Minnesota Health Department announced that it will study whether an unexpected number of mesothelioma deaths among former iron ore miners is linked to asbestos and necessitates exposure limits.
It’s also Work Zone Safety Awareness Week, which aims to reduce the number of accidents and injuries in roadway work zones.
Other types of workers whose health and safety are in the news include:
By David Michaels
The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products, gets skewered again – this time in a piece by Christopher Moraff in the American Prospect Online. (We’ve been covering the issue here at TPH; more materials on the link between PDUFA and the drug safety crisis are also posted on DefendingScience.org).
Following hot on the heels of yesterday’s Washington Post/Bloomberg critique by Cindy Skrzycki, Moraff summarizes the shortcomings of PDUFA raised by the Institute of Medicine, the Government Accountability Office, and the letter sent by 22 experts on drug safety and regulation asking Congress not to reauthorize PDUFA:
User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug’s approval — the equivalent, according to one former chief editor of The New England Journal of Medicine, of “putting the fox in the chicken coop.”
By David Michaels
The Wall Street Journal (sub required) is reporting that the White House will bypass the Senate confirmation process and announce later today that President Bush has given a recess appointment to Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA). The office, part of the Office of Management and Budget (OMB), oversees all of the Administration’s regulatory and especially anti-regulatory activities. (Some background on President Bush’s efforts to get her confirmed are here and here).
By David Michaels
The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the drug makers for a big piece of its budget, and the money comes with lots of strings – especially ones that limit FDA’s spending on drug safety. (Here is last week post on the NY Times editorial opposing PDUFA.)
In today’s Washington Post Cindy Skrzycki’s The Regulators column has a terrific piece on the letter written by leading drug safety and policy experts asking Congress to end PDUFA. Clearly, FDA needs the money PDUFA brings in; in fact, it needs a much higher level of funding to do its job right. So we have asked Congress for a temporary reauthorization, without PDUFA’s handcuffs, until the agency can be supported with appropriated money. Read the rest of this entry »
A few hours ago, the Supreme Court ruled in Massachusetts vs. EPA that EPA has the authority to regulate carbon dioxide from auto emissions. (For background on the case, see this post.)
David Stout of the New York Times summarizes:
