Last fall, however,  Reps. Ralph Hall (R-TX), Dana Rohrabacher (R-CA), Andy Harris (R-MD), and Dan Benishek (R-MI) introduced legislation  that would compromise the scientific integrity of  the Scientific Advisory Board.

Today I am testifying  in a congressional hearing to examine a new version of that legislation. This draft bill contains provisions that would slow the work of the Scientific Advisory Board, remove longstanding and widely accepted practices for dealing with conflicts of interest and reduce the expertise of Scientific Advisory Board members. It will probably not surprise you that I am not a big fan of this proposed legislation.

Slowing the committee down

The Scientific Advisory Board is already overburdened and does not need its scope broadened – especially in this time of budget cuts and trying to do more with less funding. Asking the SAB to respond in writing to every submitted comment might seem like a good idea except that they already read and consider them and any special interest could bring the committee’s work to a virtual standstill by submitting thousands or even tens of thousands of comments every week. Adding red tape is a tool long used by special interests to delay regulations that protect your health and safety.

Conflict of interest

I will tell Congress that taking money from a private interest does affect decision-making. That’s why we have ethics in government laws and that’s why scientific journals ask scientists to disclose their funding sources.

Removing key experts

I will tell Congress that the National Academies of Science, the National Institutes of Health, and the National Science Foundation all successfully prevent scientists from reviewing their own work without removing them from their committees.

I recently worked with UCS President Kevin Knobloch when he participated in a study by the Bipartisan Policy Center on this topic and was a member of the Research Integrity Roundtable of the Keystone Center when they reported on dealing with conflict of interest and bias in scientific advisory panels and I will tell Congress how we can do better so you can grab a glass of water, take a gulp of air or walk down the street and trust that the best and most independent scientists are helping the EPA protect you!

If you want to follow along you can watch here.

These are all very important discussions, but one key to the future success of science journalism and the accuracy, depth, and sophistication of online and social media science coverage is this: easy, timely, and frequent contact between those writing about science and those doing science.

Sadly, the report card released today by the Union of Concerned Scientists  – Grading Government Transparency – reveals that scientists in the federal government still face barriers to talking with the public and the press. Out of the 17 agencies included in the report card, six have no available communications policy or have a low scoring one. At many other agencies, both scientists and journalists describe deadlines passing while reporters wait for permission to interview or even chat on background with agency scientists.

Why Do Journalists Need Scientists?

It is critical that at least some investigations into scientific controversies and scientific practice originate outside science. When trained journalists ask scientists probing questions, the quality, utility, and importance of their reporting go up.

This is especially true for journalists who rarely report on science, or are not immersed in highly-complex scientific topics. They need to talk to scientists in order to understand and evaluate both the quality of the research and what the findings mean. If we place federal scientists off-limits, then journalists can be left with only press releases and other secondary documents created by public affairs officials and other non-scientists as their sources.

But access to researchers in the field also helps all reporters critically evaluate scientific findings and elucidate their meaning. And this is just as true for those writing for online audiences as it is for traditional media. Good science reporting starts with a grasp of scientific concepts and ends with a journalist’s ability to investigate. Both of these are stymied when agency scientists need permission from public affairs officials to chat with reporters, which some of the agencies we analyzed require.

I wrote on the state of scientific integrity in U.S. Federal Agencies last week. Both those results and today’s report card tell two stories: one, of some agencies trying to become more open and two, a story of other agencies still not reaping the benefits of transparency. Americans lose out when communications policies put up barriers instead of facilitating the free flow of scientific information. Both science communication and science journalism matter and both require access to scientists.

And for good reason. The United States has enjoyed prosperity and health in large part because of its strong and sustained commitment to independent science. Interference in science threatens our nation’s ability to respond to complex challenges to public health, the environment and national security and raises the possibility of lasting harm to the federal scientific enterprise.

Dr. John Holdren later released guidance for the agencies as they set about writing their policies and plans for implementing the president’s principles.

Dr. Holdren’s guidance was a welcome first step for addressing the endemic problems UCS has tracked at federal science agencies. We have documented and described examples of falsifying data and fabricating results, selective editing of reports, intimidating and coercing scientists, censoring and suppressing scientists, hiding, suppressing and delaying the release of scientific findings, disregarding legally mandated science, allowing conflicts of interest, and the corrupting of scientific advisory panels.

In addition, deeper changes in the structure and policies of the executive branch can also threaten scientific integrity. These include, for example, centralized decision making, homogenized agency decision making, reduced transparency, unnecessary bureaucracy, retaliation against whistleblowers, allowing officials to move too easily between industry and government posts, removing science from decision making, and weakening enforcement and monitoring.

To protect the integrity of science, the Holdren memo outlined four areas for policy development:

• foundations of scientific integrity,
• public communications;
• use of federal advisory committees; and
• the professional development of government scientists and engineers.

The memo did not specifically mention many important details including reforming the regulatory process, protecting monitoring programs from targeted elimination and the enforcement of current science-based laws.

In the ensuing years, agencies have found different ways to comply with Dr. Holdren’s guidance. More than 20 agencies, offices and bureaus that deal with scientific issues have created their versions of scientific integrity policies. They vary considerably in breadth and quality.

Today, we are releasing our analysis of the strengths and weaknesses of these policies. Our bar is higher and more comprehensive than the one set by OSTP. Simply repeating the words of the Holdren memo, which some agencies opted to do, will not lead to the changes needed to protect and promote scientific integrity. We looked for evidence that an agency considered the policies it had in place and developed specific plans to fill gaps that left threats to scientific integrity unaddressed.

Twenty-two agencies submitted policies or memos to OSTP. The results:

Six agencies submitted policies that actively promote and support a culture of scientific integrity. These include the Centers for Disease Control, the Department of the Interior, the Environmental Protection Agency, NASA, the National Oceanic and Atmospheric Administration, and the National Science Foundation.

Five agencies submitted policies that also promote and support scientific integrity but need additional work to ensure meaningful long-term progress. These include the Department of Homeland Security, the Department of Commerce, the Department of State, the Food and Drug Administration, and the Marine Mammal Commission.

Eleven agencies submitted policies that do not make adequate commitments to achieve the preservation and promotion of scientific integrity. These include the Department of Defense, Department of Education, Department of Energy, Department of Health and Human Services, Department of Justice, Department of Labor, Department of Transportation, Department of Veterans Affairs, the Office of the Director of National Intelligence, US Agency for International Development, and the US Department of Agriculture.

The good news is that all 22 policies repeat some important parts of the Holdren guidance – for example, all note that officials should not suppress or alter scientific or technological findings and most pledge to:

• make Federal Advisory Committee conflict of interest waivers public;
• refrain from editing the products of advisory committees;
• select candidates for scientific positions based primarily on their scientific credentials;
• ensure that the research used in policy decisions undergoes peer review; and
• promote and facilitate the professional development of scientists such as allowing government scientists and engineers to become editors or serve on editorial boards of professional or scholarly journals.

But many policies have significant flaws:

• Seven agencies require permission from supervisors or public affairs before scientists can discuss their research results;
• Nine agencies limit the first amendment rights of their scientists by not allowing them to speak about their research as private citizens;
• Seven agencies do not have final policies available on their websites or have policies posted that have expired;
• Fourteen agencies have policies that do not apply to contractors and other non-career employees;
• Not one agency has updated its policy to reflect the Whistleblower Protections and Enhancements Act of 2012;
• Not one agency is posting a record of who meets with agency officials and only 2 regularly post the calendars of their top officials;
• Not one agency agreed to separate scientific and technological information from draft regulations or other pre-decisional documents so that the science considered in decision-making can be released and protected from political influence by the White House or other agencies; and
• Not one agency chose to better define what constitutes a conflict of interest. A meaningful definition would address who is covered under conflict of interest rules (just the individual, or also his/her spouse and children?), how far back disclosure should go (one year? five years?), or what constitutes a conflict (a cup of coffee? $50,000?) as was suggested in a recent report by the Research Integrity Roundtable of the Keystone Center.

Some agencies that both undertake and use a great deal of scientific analyses did not submit policies. Examples include the Social Security Administration, the Department of Housing and Urban Development, and the Department of the Treasury. While commissions are independent, the Marine Mammal Commission still submitted a policy. I wish the Consumer Product Safety Commission, the Nuclear Regulatory Commission, Securities and Exchange Commission, Federal Elections Commission, National Transportation Safety Board and other commissions had done the same.

I commend the changes that have been achieved, but in no way are we done. A future administration, especially one willing to attack science, could still wreak havoc on our scientific enterprise with disastrous consequences for our health and safety.

I want to pick up produce in my local market knowing that our food inspectors are using independent science to declare it safe from contamination. I want to take the medicines my doctor prescribes feeling sure that if a reviewer at the Food and Drug Administration feels industry pressure to push a drug along despite faulty clinical trials, that there was a place to report that and consequences for their supervisor. I want air quality standards to be based on science with a margin for safety – just as the clean air act requires so that all our families can breathe easier. I want to know that if a reporter calls the Environmental Protection Agency to talk to a scientist, that they do not miss their deadline while the public affairs bureaucracy decides to whom they may speak. And good leadership at the agencies, good scientific integrity policies, and full implementation of these policies can give us all that and more.

So let’s work to make sure that in the next four years we get this done and done right!

This has been a contentious issue within the scientific community for quite a long time. Many have long argued that, especially for research underwritten by taxpayers, open public access to scholarly journals would have a positive benefit, while others have worried, for example, about its effects on publishers. Research released last fall claims that 340,000 scholarly scientific articles were published by 6,713 open access journals during 2011, and that number is growing. Putting that in context as best I can – it seems about one half of 1 percent of scientific papers are now available through open access business models. The three most common are: published in subscription-based print journals with open access content, published in online-only journals with no charges, and published in online-only journals with an article-processing charge.

Why do business models matter? Well, for many scientific societies – especially the smaller ones – their business model depends on their revenue from journal publication. Is this a case of no free lunch? Someone somewhere along the chain from research to article will have to pay for the publishing of the papers. Although this can be much less costly now that we can do this without paper and ink, someone must still organize the peer review, perform general editing and citation indexing, and oversee the process. So perhaps we shall see an increase in the fees charged to authors.

This move by the White House is in response to an online petition on the White House website demanding free access over the Internet to scientific journal articles arising from taxpayer-funded research, which acquired 65,704 signatures. In a response to those who signed the petition, Dr. Holdren said “We wanted to strike the balance between the extraordinary public benefit of increasing public access to the results of federally-funded scientific research and the need to ensure that the valuable contributions that the scientific publishing industry provides are not lost.”

Bipartisan legislation introduced this month would require federally funded research to be available to the public within 6 months of publication. This memorandum gives federal agencies a 12-month embargo before offering access and allows agencies to petition for longer—although news coverage suggests that this compromise is not making everyone terribly happy. Also Jeffrey Beall suggested the fee-based models may well be leading to fraud and corruption of the entire process in a piece published in Nature last fall.

The NIH Public Access Policy might be a good place for agencies to turn for an example of a system that has been around for the last five years. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication and that they are accessible on the site no later than 12 months after publication.

The memo specifically directs that government-funded scientific research articles be “made available to and useful for the public, industry, and the scientific community”. Interesting choice of words given that so much of our frustration with the open government responses by agencies is that although strictly speaking they have made data sets available to us – they have fallen short on making the data useful for us. I hope, for example, we will see more searchable and accessible documents and fewer data dumps in obscure formats.

Also notable is the written timetable for implementation—requiring meetings and reports at very specific intervals. Too bad, despite our repeated urging, the White House’s Scientific Integrity Memorandum did not offer the same for the implementation of policies establishing rules for scientific openness and conduct at government agencies.

For example:

“EPA has a policy of open transparency. I think that EPA has done the best job it can to give the scientists the platform they need to speak the truth and develop the data. There is no question that EPA carefully manages EPA’s business, which means that not everybody has the credibility within the agency to speak to everything going on in the agency…but we work very hard to make sure that the science is carefully considered and that we project as truthfully as we possibly can and provide an opportunity for our scientists to continue to excel at what they do.”

Photo: UCS

The EPA has a proud tradition of transparency dating from 1983 when William Ruckelshaus took over the troubled agency. You can find the press release announcing his principles for how he would run the agency here – but my favorite part is the quote from a memorandum to all employees, in which he said, “When I recently appeared before the Senate Committee on Environment and Public Works, I promised that EPA would operate ‘in a fishbowl.’ I said, ‘We will attempt to communicate with everyone from the environmentalists to those we regulate and we will do so as openly as possible.'”

“In order to make the public fully aware of any contacts with interested persons,” Ruckelshaus wrote, “I have directed that a copy of my appointment calendar for each week be placed in the Office of Public Affairs and made available to the public at the end of the week.” He added that “all other key EPA officials will make their appointment calendars available in a similar manner.”

Those are some big shoes to fill. Under the leadership of Lisa Jackson, the agency drafted one of the strongest scientific integrity policies in the executive branch. The policy clearly states scientist and researcher rights to express personal opinions with appropriate disclaimers and grants scientists the responsibility to review, approve and comment on final version of any scientific document that relies on their research or identifies them as a contributor.

Another pair of shoes to fill. But given what I have seen of Gina McCarthy, I think she might be able to do it and then some. Let’s hope she is named, confirmed and at her new desk in short order because there is still a great deal to get done. Reporters still have trouble connecting with agency scientists in a timely fashion. And implementation of the whole scientific integrity policy is far from done.

We were somewhat critical of Dr. Holdren’s memorandum when it was released for two reasons. First, it was a year and a half late. Second, it had several glaring omissions, particularly regarding the ability of government scientists to communicate with the media.

So what has happened over the past 24 months?

Dr. Holdren’s memorandum outlined guidance for agencies in five areas: the foundations of scientific integrity in government, public communications, use of federal advisory committees, professional development of government scientists and engineers, and policy implementation. 23 federal departments, agencies, commissions and offices have drafted and finalized scientific integrity policies, many of which can be found here.

The policies vary in quality and comprehensiveness. Some agencies and departments broke significant new ground. Others did the bare minimum. Whether a policy has a meaningful impact on federal policy making will depend on the scientific integrity policy itself, its implementation, and how much agency leaders embrace it.

In January, as the president prepares to embark on his second term, we will release a critique of each policy. There is clearly more work to be done by the federal government, and we expect that our analysis will help both the White House and executive branch agencies realize the administration’s original goal.

This was especially important with regard to A Climate of Corporate Control, our investigation that examined how leading U.S. companies influence public and policymaker understanding of climate science and support for climate change policy action. We gathered data from a great many sources, including company websites, tax filings, comments on government findings, annual reports, shareholder actions, congressional testimony, leaked documents, and interviews with company executives.

One of the many topics we examined was how companies support various non-governmental organizations that influence policy. We chose to focus on organizations that were most active and influential on climate science and policy issues as measured by visibility in the news media and independent assessments of think tank activity and influence (for more specifics on methodology, see page 52 of the report). One of these was the Reason Foundation, which we found received support from the Occidental Petroleum Charitable Foundation and from the General Electric Foundation.

General Electric’s Influence over the Discussion around Climate Change

Reason magazine’s Ron Bailey took exception with our claims about General Electric funding the Reason Foundation (the magazine is editorially independent from the foundation). He noted that we counted funds GE gave to several non-profit groups through an employee matching gift program. These programs allow individual employees to choose where their donations (and GE’s matching gifts) go. In contrast, funds from GE and its corporate foundation are directed by company executives. We have updated the report to remove references to the matching gifts.

The data still support our overall conclusion that GE has taken contradictory actions when it comes to climate change science and policy. While we now conclude that the company has only supported think tanks and other outside groups that accurately represent climate science, our finding that it is a member of trade groups that take contradictory positions on climate change still stands (see figure four of the report, page 13). GE representatives sat on the boards of pro-climate trade groups, such as the American Wind Energy Association, and the boards of anti-climate trade groups, such as the National Association of Manufacturers. In addition, GE donated to the Yes on Prop 23 campaign, which would have overturned California’s climate change law. (A detailed company profile can be found here.)

We looked again at the 2009 and 2010 foundation tax filings (IRS Form 990s) for all 28 companies in our sample and found that the General Electric Foundation was one of only a few companies that separated out matching gift donations from other donations. Since the donations from these company foundations are either labeled with a purpose other than a matching gift or are generally larger sums (in the thousands of dollars), we are confident that these donations are not likely to be matching gifts. We invite any company in the report to provide documentation to the contrary.

The Reason Foundation’s Take on Climate Science and its Corporate Support

Mr. Bailey also disputed our characterization of the Reason Foundation as a group that misrepresents climate science. I drew his attention to our criteria for misrepresentation of climate science (outlined in our methodology, appendix A of the report) and showed him where on the foundation’s website we found information that led us to characterize Reason as such. In his response, Mr. Bailey did not refute our claim that the Reason Foundation misrepresents climate science. He also neglected to discuss a $10,000 donation the foundation received from the Occidental Petroleum Charitable Foundation and instead focused on General Electric.

The Trouble with a Lack of Disclosure from Corporations

The public information we have on each company’s donations to pro-climate or anti-climate entities varies considerably. In terms of donations to think tanks and other outside organizations, many companies do not choose to distinguish different types of gifts.

Some companies may choose to make donations directly to these groups rather than through their corporate foundations, avoiding disclosure completely. In fact, a recent study conducted by Center on Philanthropy at Indiana University estimated that only 31 percent of corporate donations were made through corporate foundations in 2010.

When it comes to donations to trade groups, companies can be similarly secretive, and the picture there is far from complete. As my colleague Celia wrote the other day, we don’t know what we don’t know.

Inappropriate Corporate Influence over the Process Persists

Many of the country’s leading companies have taken contradictory actions when it comes to climate change science while pumping a tremendous amount of resources into influencing the discussion. Corporations skew the national dialogue on climate policy in a variety of ways—making inconsistent statements across different venues, attacking science through industry-supported organizations, and taking advantage of the secrecy allowed them by current legal and regulatory structures.

Solutions are complex, but include the following, centered around transparency and accountability:

•  Companies should disclose more information on how they influence the conversation on climate change and other issues of public interest.
• Congress should investigate ways to require more disclosure of corporations’ political activities.
• The SEC should require companies to disclose their political contributions and should specifically require that climate change be addressed in reports on business risks.
• Investors and consumers should continue to work both individually and collectively to demand transparency, accountability, and integrity in the private sector.
• The media should be mindful of potential conflicts of interest among the experts and other individuals they rely on for information, and disclose such conflicts when found.

On these points, we should all be able to agree.

Encouragingly, a government report released today details steps the agency will take to allow the FDA staff who work on medical devices to better resolve scientific disagreements.  But sadly, I fear that the pressure to fast track drug and medical device approvals may discourage researchers from voicing dissenting scientific opinions.

There’s certainly a lot of work to be done. A recent UCS survey of FDA scientists found that 244 respondents (including 39 scientists at CDRH, the FDA’s Center for Devices and Radiological Health) felt they could not “openly express any concerns about the mission-driven work of their agency without fear of retaliation.”

That’s no surprise. In the past, we have seen scientific disputes ruin careers. We have also witnessed cases—like Vioxx—where reviewers who raise concerns about a drug or device’s safety and effectiveness face threats and retaliation.

Today’s Report

In October 2009, CDRH put forward new policies and procedures for taking care of scientific disagreements among staff related to regulatory decisions. The Department of Health and Human Services Inspector General (IG) was asked to evaluate the effectiveness of the new policies and procedures.

An FDA engineer measures the magnetic fields emitted by a magnetic resonance imaging simulator used in testing MRI compatible medical devices. Photo credit: Food and Drug Administration

The IG found several challenges regarding implementation: the disagreement documentation and resolution process, awareness of employees on the policies and procedures, general confusion about regulatory definitions and processes, and “staff perceptions about expressing differences of opinion.” He recommended that FDA better train reviewers and managers, better define of the process for documenting and resolving scientific disagreements, and better define who is responsible for adequate documentation.

Other Improvements Regarding Scientific Disagreements

The FDA’s new scientific integrity policy also takes some steps forward in resolving dissenting scientific opinions. The policy contains the following language:

“Scientific Dispute Resolution at FDA” (Staff Manual Guide (“SMG”) 9010.1) requires the agency’s organizational units to establish processes for resolving scientific disputes. These processes must include, among other things: key messages that employees are encouraged to voice scientific disagreements and that they are protected from retaliation and repercussions for raising such disagreements within their organization; a requirement that the head of the organization render a written decision if the dispute cannot be resolved at a lower level; and appropriate timeframes. The agency-wide SMG also provides a mechanism for employees to elevate scientific disputes to the Office of the Commissioner. An Agency Dispute Process Review Board, chaired by the agency’s Chief Scientist, is then responsible for conducting full and fair evaluations of the disputes to evaluate whether the appropriate processes were followed, whether the decisions made were based on consideration of all relevant evidence and views bearing on the scientific question at issue, and whether the initiating employee was provided an opportunity to express his or her concerns at all appropriate levels.

This is strong language. The policy should go even further, however, by requiring the documentation and public disclosure of dissenting opinions so that we can understand all of the science that was relied upon in making a drug or medical device approval decision. Our line-by-line analysis of the FDA policy is here.

What This Means

I was heartened to learn today that the FDA is taking steps to improve the ability of its scientists to have frank and honest discussions. This is a situation where an agency saw a problem, and took steps to address it.

In the wake of several high-profile scientific disputes about medical device approval among FDA staff, the FDA created a policy to deal with dissenting opinions. The Inspector General assessed how well the new policy was working and made recommendations to improve its implementation. And the FDA agreed to work on implementing those recommendations.

On paper, this is a successful outcome. However, there are unanswered questions about how effectively these reforms can be implemented. The user fee agreements the FDA and Congress are negotiating with industry currently set tight timetables on drug and medical device approval. Let’s hope that the FDA can find a way to prioritize science and safety while meeting the demands of the user fee agreements.

But NASA falls short of the standard set by agencies like NOAA and the EPA. Why? Its scientific integrity policy does little more than link to twenty related policies, rather than succinctly stating clear standards for scientific integrity and procedures for dealing with violations of it.

Together, the twenty referenced policies add up to more than 200 pages of text. The lack of clear definitions, principles and procedures makes the scientific integrity policy daunting and difficult to navigate.

NASA’s scientific integrity policy should be clear and concise, and in one location. Simply linking to hundreds of pages of existing information is certainly a barrier to fully developing a culture of scientific integrity.

Here’s the email:

——– Original Message ——–

Subject: Recommitting to Scientific Integrity

Date: Tue, 15 May 2012 09:31:10 -0500

From: HQ-NASA INC

AGENCYWIDE MESSAGE TO ALL NASA EMPLOYEES:

Point of Contact: Sarah Dewitt, Office of the Chief Scientist, NASA Headquarters, 202-358-2451

————————————————————————

MESSAGE FROM THE CHIEF SCIENTIST

Recommitting to Scientific Integrity

The iconic success of NASA is planted firmly on three foundational elements: innovation, inspiration, and integrity. While innovation and inspiration are visible through our endeavors and successes, it is our integrity – how we work, and our commitment to excellence and openness – that earns us the trust of the public and ensures our continued ability to inspire and innovate.  Integrity is woven throughout the fabric of NASA.  It has always been there. And each and every day, we recommit ourselves to keeping it there.

Integrity is embedded in the rules and requirements that govern our professional behavior across all technical disciplines – in aeronautics, science and human exploration. It entails the responsible conduct of research and the pursuit of standards aimed at maintaining public trust in the scientific work that we perform.  NASA has had policies in place for several years to meet these aims while also preserving employees’ freedoms to share their work with the public and their professional peers.  A commitment to responsibility, transparency, and freedom in research has been essential to NASA’s ability to achieve incredible scientific research results and engineering feats.  We at NASA should all be very proud of these achievements.

In response to a request from the Obama Administration to all federal agencies engaged in research and development activities, a team at NASA has recently revisited our policies.  We expanded them to make selections of federal advisory committee members more transparent and to clarify the requirements and steps for employees to participate in outside professional organizations.  We also used this opportunity to reaffirm our employees’ freedom to speak openly with the press, as addressed in the agency’s current communications policy, the public and their peers about the work they do.  We have assembled the full set of policies in a Framework on Scientific Integrity accessible on NASA’s website at:

http://www.nasa.gov/news/reports/sif.html

Despite the name, this responsibility actually extends far beyond just science. Whether we are scientists or engineers, accountants or astronauts, all of us are responsible for making NASA’s incredible achievements possible and, thus, for upholding principles of scientific integrity in our work. I invite you to take a moment to review the framework and submit any questions or comments through the InsideNASA website. I appreciate your continued commitment to the ideals outlined in this framework. It is our integrity that helps make NASA such a great place to work. Your awareness of the freedoms and responsibilities these policies support will help us continue to pursue new knowledge, fuel wonder, and make groundbreaking discoveries about the universe and our place in it.

Waleed Abdalati

Chief Scientist

National Aeronautics and Space Administration

——————————————————————

This notice is being sent agencywide to all employees by NASA INC in the Office of Communications at NASA Headquarters.

We all remember the horrible images from that tragedy. After an explosion of the BP-owned Deepwater Horizon rig on April 20, 2010, oil flowed into the Gulf of Mexico for nearly three months, releasing more than 4.9 million barrels of crude oil. The disaster has continued to have detrimental effects on marine ecosystems and wildlife, as well as devastating economic impacts on the fishing and tourism industries in the Gulf States.

Well, we’re still out there, and you can see it from space, at night:

If you look closely off the south coast of the United States in these images, you can see small areas of light from oil rigs and other manmade structures in the gulf:

Check out the Blue Marble interactive night lights map, developed by scientists in Germany using NOAA data, to explore this and other regions of the world as viewed at night. (And as my colleague Michael shared previously on this blog, NASA’s Suomi project data offer fantastic daytime imagery of our planet).

As we celebrate Earth Day this Sunday, the nighttime images shed light (literally!) on the vast impact humans have had on the planet. In addition to the light pollution, we can also consider the broader implications of this energy use for issues such as energy security and climate change. Many coastal regions, particularly the fragile ecosystem of the Gulf of Mexico, are vulnerable to climate-related disasters including stronger storms, flooding and sea level rise.

The biologist in me looks at this map and sees habitat loss where the lights are the brightest and probably elsewhere as well. I immediately think about how many species survived previous warming periods by moving north or south or up the slopes of mountains in search of suitable temperatures. But historically the habitat was continuous allowing species’ to move over time. Sadly this image tells me those corridors are gone, dooming many unique species to extinction.

As we make choices in our daily lives about consumption of resources, we should remember how climate change is reducing species diversity, with significant consequences for human health and the environment–and how important it is to invest in solutions to slow this loss.

On December 9, 2011, a panel convened by the FDA to evaluate the risks and benefits of Yaz voted to keep it on the market after deciding that the drug’s benefits outweighed its risks. Yaz had come under scrutiny after multiple independent studies found that the cardiovascular risk for women on the drug was significantly higher than other oral contraceptives (such as levonorgestrel, commonly known as Plan B).

The birth control pill Yaz increases the risk of developing a blood clot, which can be fatal. Several scientists on an FDA advisory committee who had undisclosed financial conflicts of interest voted in December to keep the drug on the market. Photo: Flickr user Stacy Lynn Baum

Washington Monthly and the British Medical Journal (BMJ) reported that at least four scientists on the panel had direct financial ties to Bayer, the drug’s manufacturer, or its affiliates. A fifth scientist had been paid by a law firm representing the company.

The committee voted 15-11 in favor of the drug; had the conflicted scientists not voted, the panel would not have recommended that the drug stay on the market. The FDA is required by law to tell the public when it allows scientists with financial conflicts of interest to serve and vote on committees by granting them waivers. But while the scientists had reported their financial ties to the FDA, the agency failed to disqualify them or publicly release any waivers.

The new wonder drug?

In 2006, Yaz was approved and was advertised as a miracle drug for women suffering from severe PMS and acne. An ad by Bayer stated, “Yaz is the only birth control proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life.” Within two years, it was the most popular birth control pill in the United States, reaching sales of $781 million in 2009.

Women like Carissa Ubersox were attracted to the claims that it reduces acne and bloating. In 2007, Carissa, a young professional working as a pediatric nurse, started taking Yaz. Less than three months later, she felt aching in her legs, and the next day was hospitalized.

The aches were caused by blood clots that subsequently traveled to her lungs, resulting in a pulmonary embolism. She slipped into a coma and stayed there for two weeks. When Carissa regained consciousness, she was blind, and remains so to this day. She has since given up her job as a pediatric nurse. “Everything that I thought I worked so hard for has disappeared,” she told ABC news.

Yaz is riskier than other birth control pills

All birth control pills carry some risk. According to the FDA, the risk of developing a blood clot when using traditional birth control pills is six in 10,000. However, five independent studies found that drospirenone, the active ingredient in Yaz, significantly increased that risk. One FDA-commissioned study found that drospirenone increased risk by nearly 75% compared to women on other birth control pills. Another study of more than 1 million women in Denmark found the risk to be ten in 10,000.

These independent studies ran counter to a Bayer-sponsored study finding no greater risk for Yaz compared to other oral contraceptives.

We owe it to Clarissa and other women that have been harmed by Yaz to do better. Scientific advisory committees should be fully independent and able to consider the best available scientific information when making recommendations regarding a drug’s safety and effectiveness compared to its alternatives. Financial pressures should never be a factor.

Where the Policies Stand

Some agencies, like NOAA and the EPA, and the Department of Interior, are well positioned to begin implementation of strong policies that have the potential to change agency culture for the better. For example, they make it clear that the policies apply to all employees and contractors. They have developed media policies that make it more difficult for agency leaders to censor scientists. They give scientists the chance to review, correct, and approve agency documents that rely upon their scientific work.

Others, like the USDA and the Department of Labor, have “fulfilled the minimum requirements” by more or less restating what is the general White House scientific integrity guidelines. This is not enough.

Some entities, such as the Department of Education and the Department of Veterans Affairs, are seeking public comment on their  policies. As the White House has noted, public comment periods have greatly improved several of the final policies that have been put forward.

And, well, we’re still waiting for some as of this moment. Once all of the policies come in, we’ll do a more detailed analysis of where agencies have succeeded and what work still needs to be done.

White House Leadership Needed on Bigger Issues

For now, this much is clear: There’s only so much the agencies can accomplish alone. None of the policies released thus far sufficiently address issues like whistleblower protection, disclosure of meetings with special interests, and interagency review of scientific documents.

These issues are bigger and need more attention and leadership from the White House. The White House should explain how it plans to address the challenges to scientific integrity that the agencies are not well positioned to tackle alone.

Policies Should be Made Accessible

Agencies and departments need to follow NOAA’s lead and do a much better job of making their policies accessible. Finding these policies should be easy, but it is not. The Department of Energy, for example, issued a general policy statement last week, has no scientific integrity landing page that I could find, and a Google search for Department of Energy Scientific Integrity Policy yields nothing useful. And there’s certainly no place on the White House website with links to all of the policies.

While we’re happy to help, agency employees shouldn’t have to depend on the Union of Concerned Scientists to keep track of them.

Implementation is Key

In a February blog post, Dr. Holdren wrote: “Publication and implementation of these policies will close an important chapter in an historic process that promises a new level of government accountability and will help ensure scientific integrity across the executive branch for years to come.”

I hope agencies and the White House recognize that the implementation part of this process is just as important as the publication part. While some agencies have assembled most of the necessary ingredients, they’re still not ready to put the pie in the oven.

Because advisory committees are extremely important to the decisions that FDA makes. Here are five reasons why the Congress can and should allow FDA to retain strong conflict-of-interest standards for its scientific advisory panels:

1) The votes of conflicted experts can make a difference in the outcome of advisory committee recommendations. A 2005 analysis of advisory votes by the Center for Science in the Public Interest found that 10 of the 32 advisors on an FDA panel evaluating the painkillers Bextra, Vioxx and Celebrex had financial ties to the makers of the drugs. In the case of Bextra and Vioxx, the conflicted experts’ votes made the difference between approval and denial. The vote to allow Bextra to stay on the market was 17 to 13, with nine of the conflicted experts voting in the affirmative. The panel voted 17 to 15 to allow Vioxx to return to the market, with nine conflicted experts voting yes.

Just this past December, the FDA convened an advisory panel to evaluate the safety of the contraceptive drug Yaz. Washington Monthly and the British Medical Journal (BMJ) reported that at least four scientists on the panel had financial ties to Bayer, the drug’s manufacturer, or its affiliates. A fifth scientist had been paid by a law firm representing the company. The committee voted 15 to 11 that the benefits outweighed the risks; had the conflicted scientists not voted, the vote would have gone down the other way. The FDA failed to disclose any of these relationships or to disqualify any of the conflicted panelists.

2) Strong opinions of those with a financial stake in the outcome can have extraordinary influence on the opinions of other panel members. A study by the National Research Center for Women and Families found that individual committee members can have a disproportionate influence on approval recommendations. According to the study, “committee members describe pressure to conform and to recommend approval, and they candidly admit that their votes for approval may not be consistent with their concerns about safety and effectiveness.”

3) There is a large pool of potential advisory panel members who are conflict-free. According to estimates by Dr. Susan Wood, a professor at George Washington University’s School of Public Health and Health Services, there are over 130,000 qualified experts in America’s 135 medical schools, 123 schools of pharmacy, and 48 schools of public health. Even if 50 percent had financial conflicts, that would leave 60,000 candidates for 500-600 FDA advisory panel positions.

4) Other agencies with even more robust standards operate committees that are free from conflicts. The National Institute of Health’s Office of Medical Applications of Research staffs consensus panels formed to evaluate complex medical issues. Panel members include scientists, health professionals, epidemiologists, and those experienced in clinical trials. These panels do not permit any conflicted experts to participate. These same conflict bans apply to the Agency for Healthcare Research and Quality, and the U.S. Preventive Services Task Force (USPSTF), which assesses the evidence of various disease prevention strategies.

5) Conflicted experts shake public faith in the integrity of the FDA and in the safety of drugs and devices. The perception that the government is acting in the best interest of companies rather than its people has eroded public confidence in the FDA’s ability to protect us from unsafe products. Conflicted experts, regardless of the level of their involvement, make the public skeptical of integrity of the federal government.

The nearly 1,000 federal advisory committees across the federal government are supposed to be independent. The committees make science-based recommendations on topics as wide-ranging as chemical and toxin exposure limits, dietary standards, and the safety and efficacy of drugs and medical devices. At the FDA alone, there are more than 500 external scientists serving on 33 committees. One of those committees, the Medical Devices Advisory Committee, has 18 separate panels.

UCS is asking Congress to require the FDA to continue to disclose and reduce the number of waivers that are granted to scientists with financial conflicts-of-interest who serve on FDA scientific advisory committees. Photo: FDA

But sometimes, FDA advisory committee experts work for the very companies whose products the agency is supposed to assess, creating financial conflicts of interest that can lead to the approval of unsafe products and significant harm to the American public.

As I described earlier this week, the FDA’s approval of Vioxx led to thousands of premature deaths and as many as 100,000 unnecessary heart attacks. But in 2005, an FDA advisory panel voted to allow the drug to return to the market. A study conducted by the Center for Science in the Public Interest for the New York Times found that that ten of the 32 members of the advisory panel had financial conflicts with manufacturers of cox-2 inhibitors (including Vioxx), and that their votes made the difference in the panel’s decision. Fortunately, the company chose not to reintroduce the drug.

Improving advisory committees at the FDA

In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA). The new law made several improvements to drug safety at FDA by creating more transparency at the agency, requiring pharmaceutical companies to pay more for FDA review of their drugs, creating a registry of clinical trials, and granting the agency more authority to monitor drugs after they are approved.

FDAAA also beefed up the efforts the agency must make to recruit panelists who do not have conflicts of interest. First, the law requires the agency to gradually reduce the number of conflicted experts it selects. Even more importantly, when the FDA selects an expert with financial conflicts and grants that panelist a waiver to participate, the law requires the waiver to be part of the public record.

The reforms in FDAAA, coupled with the leadership of FDA Commissioner Margaret Hamburg, appear to be having an effect. A recent UCS survey of FDA scientists found that while corporate and political interference on agency scientists persists, more FDA scientists believed in 2011 that the agency is moving in the right direction compared to 2006.

Incredibly, the conflict-of-interest reforms are at risk of being eliminated, as Congress considers changes to FDAAA this year.

More work can be done

Despite this progress, conflicted experts still wield influence. For example, in 2010, FDA convened a panel to evaluate whether the diabetes drug Avandia should be recalled due to an increased risk of heart attack. The decision that would have had a significant impact on the drug’s maker, GlaxoSmithKline (GSK). One of the panelists, Dr. David Capuzzi, had served as a paid member of GSK speaker’s bureau for several years and had earned nearly $7,000 in speaking fees.

Dr. Capuzzi was one of just three members of the committee to vote for keeping Avandia on the market without any stronger warnings or restrictions. Dr. Capuzzi’s conflict was not noted by the FDA, but was uncovered only by a media investigation after the meeting occurred. These undisclosed financial conflicts weaken the public’s faith in the FDA.

UCS has advocated for additional reforms to scientific advisory panels that would further limit the ability of conflicted experts to inappropriately sway the agency’s decisions. We support a total ban on the use of experts with conflicts, except in those unique situations where the FDA is considering drugs that address rare diseases where the pool of experts is very small. UCS also has urged the FDA to screen experts more carefully for conflicts. Congress should continue the progress that has been made since 2007 by further tightening restrictions on conflicted experts.

In 2004, the pharmaceutical company Merck voluntarily recalled the drug Vioxx after four years on the market, marking the start of the end of what FDA scientist Dr. David Graham stated in testimony before the Senate was the “single greatest drug safety catastrophe in the history of this country or the history of the world.” For many, that was four years too late. Dr. Graham calculated that the drug had resulted in 55,000 premature deaths from heart attacks and strokes and caused 100,000 unnecessary heart attacks in the U.S. alone.

How did this happen? It was a combination of corporate interference and suppression of science at the FDA.

Just prior to the approval of the drug in 1999, Merck implemented aggressive marketing and public relations strategies to boost sales of the drug. The marketing strategies came in direct conflict with the science but in the interest of profits, science took a back seat.

By no means was this out of the ordinary. It has been revealed through litigation that pharmaceutical companies have used a variety of methods to shape the science and the debate to fit their needs. In the short term, this strategy worked for Merck. In 2003, alone, Vioxx sales totaled $2.5 billion.

Merck made sure the company would have something to celebrate with Vioxx by misrepresenting the results of clinical trials and ghostwriting twenty scientific articles and publishing them under the names of respected scientists. An FDA scientist who raised concerns about the drug was attacked by his superiors. Photo: Flickr/PGecko

Marketing teams at Merck played a direct role in the clinical trials. When results from a clinical trial comparing Vioxx and naproxen showed that Vioxx increased cardiovascular risk, Merck officials spun data and stated that, instead, naproxen decreased cardiovascular risk. Merck employees ghostwrote twenty scientific articles and published them under respected scientists’ names. Dr. Gurkipal Singh testified that scientists had raised concerns about the possible cardiovascular risks of the drug as early as 1996, but Merck did not officially conclude that patients on Vioxx were more than twice as likely to suffer heart attacks or strokes until September 23, 2004 – seven days before it withdrew the drug.

While Merck is largely accountable for the scandal, systemic failures at the FDA allowed Vioxx to remain on the market. Many FDA scientists were vocally critical of the FDA’s response. Scientists raising concerns about Vioxx and other similar drugs faced intimidation and threats from supervisors and were asked to change their research. Senior FDA officials called Dr. Graham’s research “junk science” and brushed off criticisms that the FDA drug review system was operating correctly. Officials retaliated against researchers for speaking publicly about their research or attempted to censor scientists from publishing research in scientific journals. The culture of abuse and lack of oversight led Dr. Graham to state that the FDA was “incapable from protecting us from another Vioxx.”

As we previously noted, the FDA has a complex mission and has come a long way since 2004. A series of reforms such as the FDA Amendments Act of 2007 and the FDA Transparency Initiative have improved the standards for drug approval and transparency at the agency. But the agency still has a ways to go and faces continued pressure to change scientific results. And this spring, members of Congress are looking to turn back many of the 2007 reforms.

In the coming days, we’ll continue to explore how the FDA can make progress in the face of threats to its independence. We must remember that going back to the way things used to happen at the FDA means going back to medicines that do not heal, but as in the case of Vioxx, kill and handicap people we love.

I thought the enormous complexity of the drug discovery and development process warranted an explanation. So how exactly does the FDA make sure that new commercial products are ready for you?  Here’s what happens:

Step One: Initial development and testing

Living things and synthetic compounds supply the materials that may be effective in treating illness and injury in humans. Scientists explore various substances, many of which turn out to be dead ends. This initial research should demonstrate that a potential new drug is reasonably safe for initial use in humans, and that it holds some potential for treatment.

Nature provides us with many molecules that can help humans fight disease. The bark of the Pacific yew contains paclitaxel (brand name Taxol), a drug that is used to treat ovarian cancer. It is important to protect our world’s biodiversity so scientists can continue to discover these kinds of compounds. Photo: Flickr user brewbooks

Step Two: Application for testing in humans

Armed with promising results, drug developers submit an Investigational New Drug application to FDA’s Center for Drug Evaluation and Research (CDER) in which they propose “clinical trials” that will expose humans to the potential drug for the first time in limited and highly regulated ways. The application should contain pharmacological and toxicological data derived from animal studies and, if available, information on previous use in humans (often in other countries). The application also should include information about how the drug will be manufactured, who the investigators are, and how the investigators will conduct the clinical trials.

The FDA has 30 days to review the application and raise any red flags. The FDA can also stop clinical trials at any point if the agency sees problems.

Step Three: Clinical trials

The investigators conduct clinical trials in three initial phases described here. Data from these three stages are used to prepare a drug for evaluation.  Phase I trials are conducted on a very small group of healthy and non-healthy people to evaluate safety, dosage, and side effects. Once changes are made based on Phase I results, more sick people are exposed to the drug in Phase II to evaluate effectiveness and further understand side effects. If the second phase of trials demonstrates adequate effectiveness,  Phase III begins, which is designed to help reviewers determine whether the benefits of the drug outweigh the risks.

Step Four: Application for drug approval

If the clinical trial data is promising, the drug’s sponsor submits a New Drug Approval application to the FDA. In addition to the data, the application includes information about how the drug will be manufactured, proposed dosage, and proposed packaging and labeling.

Step Five: Evaluation of application

Under the Prescription Drug User Fee Act (PDUFA), the agency has ten months to review the application. CDER scientists review the data and proposed labeling. If they determine that the drug’s benefits outweigh its known risks, the drug is approved for sale.

Step Six: Post-market monitoring

Data from a fourth stage of clinical trials is collected after a drug is approved to refine its use. The FDA monitors a drug’s safety and efficacy by maintaining a program called MedWatch that allows the reporting of adverse side effects. Many believe that the FDA does not have adequate resources to carry out effective post-market monitoring.

Step Seven: Development of generics

When the patent on a new drug expires, manufacturers apply to FDA to develop generic versions of the drug.

The FDA has a decent summary of how this process worked to develop a new drug to prevent osteoporosis.

Both industry and FDA make big investments in this process. Both have enormous stakes in the outcome. This is why it behooves us to build in safeguards that ensure the process works and stays true to the science. This includes more transparency in the way FDA makes drug approval decisions. This also includes retaining and increasing limitations on conflicts of interest for the scientists who serve on supposedly independent scientific advisory committees that are set up to give advice to FDA on the safety and efficacy of new drugs.

These challenges can be met through the work of Congress to reauthorize the legislation that governs the drug approval process and by the FDA improving and fully implementing its scientific integrity policy.

An FDA microbiologist tests seafood for microorganisms.

The survey can be compared to another survey of FDA scientists completed by UCS in 2006. In the survey released today, the scientists told us the agency is moving in the right direction, and they feel more supported by supervisors and FDA leadership. FDA scientists express concern on several fronts, including their right to publish research and communicate with the public, the degree of corporate and political influence on regulatory decisions, and the overall transparency and accountability of the agency’s decision making.

In short, the survey tells us that the problems FDA faces are deeply systemic, and that strong leadership isn’t enough to eliminate political interference in decision-making at the agency.

Next Steps

First, I’m encouraged by the fact that the FDA last month released a scientific integrity policy. But the agency should now formally seek public comment on that policy to help strengthen it. As the president’s science advisor has said, scientific integrity policies tend to improve considerably as a result of public input.

Second, the FDA’s demonstrated progress should serve as a warning to Congress to keep its hands off reforms that have increased the FDA’s independence. In 2007, in light of numerous product recalls and congressional scrutiny of FDA scientists whose work was suppressed and censored, Congress approved the Food and Drug Administration Amendments Act. That law required that the FDA be more transparent in its drug approval process, and directed the agency to reduce the number of experts on its advisory panels who have financial stakes in panel recommendations.

This year, Congress is again considering major FDA legislation, part of its must-pass reauthorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act. The fragile progress that the FDA has made, as evidenced by this survey, would be harmed by legislative proposals now pending before lawmakers, which would relax conflict of interest standards and make science at the agency significantly more vulnerable to special-interest pressures. One legislative proposal would actually change the FDA’s mission to include job creation, diluting its core obligation to protect American families from unsafe drugs, food, and medical devices.

The FDA is big and complex—according to the agency, it is responsible for the safety of items accounting for 25 cents of every dollar spent by consumers.  It is important for the agency to continue the progress it has made in restoring scientific integrity to federal policymaking. It is equally important for Congress to build upon the reforms that are already in place.

This month, EPA Administrator Lisa Jackson made good on her pledge to release a final, non-cancer scientific assessment of the health consequences of dioxin exposure. Photo: EPA

On January 25, I wrote to EPA Administrator Jackson asking her to release the non-cancer portion of the dioxin assessment by the end of January as she had promised in August 2011. Representatives of many other organizations made similar pleas (the Center for Health, Environment, and Justice kept a pretty good list).

EPA scientists completed their first draft of the assessment in 1985, an assessment that has been challenged by industry ever since. And on February 17, despite pressure from industry for even more delays, the EPA made good on its pledge, just a couple of weeks late.

And after nearly three decades, that didn’t feel like too big of a deal.

The EPA found that at current exposure levels, dioxins do not pose significant health risks (other than cancer). In addition to cancer, dioxins can harm human reproductive, immune, and hormonal systems and cause a severe skin disease called chloracne. EPA has said it will complete the dioxin cancer assessment “as expeditiously as possible.”

The non-cancer assessment enables the EPA to establish cleanup levels at toxic waste sites and set specific limits on industrial releases of dioxin to ensure that exposure levels remain low. EPA says that air emissions of dioxins have decreased by ninety percent since 1987 because of efforts by governments and industry.

UCS submitted comments on an August 2011 draft policy and encouraged our supporters to do the same. UCS also put forward a line-by-line analysis of the draft policy.

The more than 25,000 comments EPA received on the draft policy seem to have made a difference. The agency should be commended for the attention it has devoted to this issue and the open process it used to develop the policy. With the long history of political interference at the EPA, it is all the more important that the agency’s policy be strong and comprehensive.

Overall, the policy makes strides towards protecting scientific integrity at the EPA, but falls short in several areas, including the release of visitor logs, definition of conflicts of interest, and protection of EPA scientific research when it is reviewed by the White House or other government agencies. Some of these challenges should be addressed by the White House, as it is clear that greater coordination and leadership are necessary.

The EPA also needs to put forward a detailed implementation plan to make the policy meaningful.

In a blog post last week, White House Science Advisor John Holden asked all federal agencies and departments covered by the White House Scientific Integrity Guidelines to publicly release “their final policies or their latest draft versions” by March 30. UCS will continue to compile what is released when it is released (and if you see an agency policy that’s not on our page, please let us know).

The development of a policy, of course, is only the first step. Now, EPA must implement the policy in a way that makes it part of the agency’s culture, not just another piece of paper.

The EPA Final Policy

The draft policy the EPA released in August had several positive components that have been retained in the final policy:

• The policy has good general language about the importance of creating a strong culture of scientific integrity at the EPA, as well as the importance of transparency to agency accountability (Section IV-A).
• The policy reaffirms the right of employees to express their personal views about any topic as long as they clarify that they are not speaking on behalf of the agency (Section IV-B-1, second bullet) and even helps by providing clear language to make that disclaimer.
• The policy gives scientists the right to “review, correct, and approve” the scientific content of agency documents that rely upon their scientific work or opinions (Section IV-B-1, fifth bullet). The final policy adds a way to resolve a situation when a scientist disagrees with how her research was represented.
• The policy advances the autonomy and accountability of federal advisory committees by making scientific expertise the basis for candidate selection, publicly releasing conflict-of-interest waivers, and clarifying that committee products are independent and not subject to revision by agency officials (Section IV-C-2).
• The policy references EPA’s Principles of Scientific Integrity, which help set a positive tone and stress the agency’s commitment to independent, science-based policy making.

The EPA made the following improvements from the first draft to the final draft:

• The policy was extended to apply not just to EPA scientists but to all staff, including political appointees, managers and supervisors. Just as importantly, the policy also applies to contractors and other non-staff (Section III, first paragraph).
• The policy stresses in several places that supervisors and managers have a responsibility to uphold scientific integrity. It reiterates that supervisors and managers must not alter scientific products, intimidate or coerce scientists, influence scientific advisory boards or intentionally misrepresent scientific information (Section IV.A.3, first bullet).
• The policy expands on whistle-blower protections to underscore that whistle-blowers must not experience retaliation or other punitive actions for reporting “allegations of scientific and research misconduct or who express a differing scientific opinion” (Section IV.A.3, third bullet).
• The policy put in place a mechanism for addressing differing scientific opinions, or when an agency scientist “disagrees with the scientific data, scientific interpretations, or scientific conclusions” that are used in agency decision-making. However, the policy does not clarify whether differing scientific opinions will be reported publicly (Section IV.A.3, second bullet).
• The policy better clarifies the role of public affairs officials, stating that they are not to “alter or change scientific findings or results” and that they should “ensure that science is plainly and clearly communicated for the intended audience in a timely fashion (Section IV.B.3, second bullet).
• The policy improves public accountability by requiring the agency to release a report annually on the state of scientific integrity at the EPA. The policy also requires an agency-wide annual meeting on scientific integrity that involves senior leadership and input from EPA scientists and regional offices. This could be made even better by requiring annual reporting of the number of allegations of scientific misconduct that were made and the number that were resolved (Section V.D).

The following components of the policy have improved but could be further clarified:

• While the policy prohibits EPA employees, from impeding the timely release of scientific findings or conclusions, it does not establish specific time frames for the dissemination of scientific research. (Section IV.A.2, first and second paragraphs)
• The policy better clarifies that notification of public affairs officials is necessary when “communicating in an official Agency capacity” (Section IV.B.1, third bullet). It could be improved by explicitly stating that permission is not necessary.

There are also areas of the policy that are still problematic or not addressed:

• In general, the policy could benefit from a “definitions” section. Definitions of potentially confusing terms are scattered throughout the document and difficult to locate.
• The policy maintains that public affairs officials should attend media interviews; in the past, these “minders” have been used to intimidate scientists (Section IV.B.3, third bullet).
• The accompanying EPA Scientific Integrity Committee Draft Charter is weak and not sufficiently specific. The EPA could provide more specifics on selection of members of the committee. Furthermore, there is no mention of whether the committee has oversight of scientific misconduct, dissenting opinions, and ethics. The policy or charter should better clarify who is in charge of the Scientific Integrity Task Force, and to whom that person reports, so we can see what political influence there may be on the task force. As this document is in draft form, the EPA should seek public input to strengthen it.
• The policy does not protect EPA scientific documents from being manipulated during White House or inter-agency review. This leaves the agency’s scientific work open to manipulation and suppression by other parts of the federal government without public accountability.
• The policy fails to address making visitor logs available. The public deserves to know who is meeting with agency officials while they are making science-based decisions so we can understand who may be influencing the science behind those decisions.
• The agency has yet to create a publicly accessible scientific integrity web page for employees to access. Compare EPA’s scientific integrity page with NOAA’s scientific integrity page and you will see where EPA comes up short.
• The agency still fails to define what constitutes a conflict of interest. The policy should explicitly state who is covered under conflicts of interest and whether they apply to spouses or grown children of an employee. It should also clarify what monetary value constitutes a conflict of interest and how far back reporting requirements should extend.

Finally, there are additional documents that should be created to improve scientific integrity at the EPA. For example, the agency should standardize a procedure for publishing scientific research (like the U.S. Fish and Wildlife Service has done) to ensure that scientists do not face unnecessary bureaucratic or political obstacles to publishing their research.

Some delays and bureaucracy are understandable, especially when the topic of an assessment is complex. But years of challenges to the science simply to delay regulation can constitute political interference. That’s why yesterday I sent a letter to EPA Administrator Lisa Jackson urging her to stand tall and release the non-cancer dioxin assessment by the end of the month and the cancer dioxin assessment as soon as possible.

So what is dioxin? Dioxin refers to a group of chemical compounds that are formed by various combustion processes. Dioxin was a component of Agent Orange, used extensively by the U.S. armed forces as an herbicide during the Vietnam War. According to the World Health Organization, dioxins “can cause reproductive and developmental problems, damage the immune system, interfere with hormones and also cause cancer.”

When EPA scientists finished their first draft of the dioxin assessment, President Reagan had just begun his second term. Here the president is pictured with Mikhail Gorbachev at the Reykjavik Summit. Photo courtesy Ronald Reagan Library

EPA scientists completed their first draft of a dioxin health assessment in 1985. Twenty-seven years ago. That’s not a typo. Quickly thereafter, the paper and chlorine industries challenged the EPA’s assessment. Since then, the science on dioxin has been analyzed and re-analyzed exhaustively, all coming to the same general conclusion: dioxin and dioxin-like compounds are highly toxic. The Center for Health, Environment, and Justice has an informative timeline (pdf, updated through April 2011) that chronicles the many delays and certain notable events related to dioxin exposure.

What was happening in 1985? Mikhail Gorbachev was leader of the Soviet Union. In South Africa, interracial marriage was finally allowed. The ozone hole was discovered. The first blood test for HIV was approved by the FDA. Back to the Future opened. Calvin and Hobbes made their debut. And Barack Obama moved to Chicago to be a community organizer.

Since 1985, we’ve changed presidents four times. And still, the dioxin assessment has not yet been completed. Of course, scientists will continue to study dioxin and refine our understanding of its toxicity. But that is no excuse for continued delays.

The EPA is under significant pressure from industry to postpone its assessment once again. Let’s hope that this time the agency does what is right.

PCAST with President Obama. Photo: The White House

Last month, Department of Health and Human Services Secretary Kathleen Sebelius shocked scientists and public health advocates by ordering the Food and Drug Administration (FDA) to reverse its science-based decision to allow access. The move was unprecedented: never before had an HHS secretary overruled a decision of the scientists and an independent scientific advisory committee at FDA.

It’s important to note that the law requires FDA to approve drugs that are safe and effective, and they must rely solely on the best available scientific information to make that determination. Not politics, not economics, and not the desires of special interests–just science. That is what keeps Americans safe while allowing access to life-saving medications.

In reviewing the secretary’s memorandum to the FDA and FDA Commissioner Margaret Hamburg’s matter-of-fact response, it is clear that the FDA was in strong disagreement with the secretary’s move. In a December 2011 New England Journal of Medicine Perspective piece, three reproductive health experts wrote, “Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls.”

HHS, notably, is one of the many agencies that has been silent on scientific integrity, despite White House guidelines that require it to develop a scientific integrity policy. It’s time for HHS to publicly release its policy for public comment, and if it doesn’t do so immediately, the White House should step in.

My testimony is below. The webcast of the event will soon be available.

“Good afternoon Dr. Holdren, Dr. Lander, and members of the council and thank you very much for the opportunity to speak with you. I want to begin by complimenting Dr. Jane Lubchenco on her scientific integrity leadership. NOAA recently released a scientific integrity policy with many excellent and I hope effective components. But sadly, only about a quarter of the relevant agencies have developed scientific integrity policies as required under White House guidelines and publicly released them.

“When Secretary Sebelius overruled the FDA regulatory decision to approve the over-the-counter sale of Plan B, she demonstrated why these policies are so critical. While the good news is that political interference in science did not occur within the FDA as has happened in the past, it did happen. It is a curious coincidence that while FDA is quite far along on what appears to be a good policy, HHS has been relatively uncommunicative and has not released any draft policy.

“In her letter to the FDA commissioner ordering her to deny approval to Plan B, Secretary Sebelius used phrases like ‘based on my review’ and ‘my conclusion’. This is exactly the situation which scientific integrity policies are created to prevent: namely, a non-scientist, political appointee overturning a decades-long process of scientific research and review both inside and outside of the FDA. This process has been upheld by many eminent scientific societies, such as the American Medical Association, and numerous scientists.

“I would like to request that OSTP ask HHS to immediately release its scientific integrity policy and open a public comment period this month. If OSTP cannot do this, Dr. Holdren should ask the president to require HHS to do so. As Dr. Holdren has rightly pointed out, those agencies that have held public comment periods greatly benefited from the over 50,000 comments submitted thus far.

“Thank you.”

In its ongoing effort to create strong scientific integrity standards in government, the White House has told federal scientific agencies and departments that they must submit “final draft [scientific integrity] policies” by December 17. NOAA released a draft policy on June 16, 2011 for public comment. The agency received more than 17,000 comments in 8 weeks. UCS also submitted its own suggestions for improving the policy, complete with a line-by-line analysis of it.

Improvements made

In comparing the first draft to the final policy, one can see that a number of improvements were made. Among the highlights of the new policy:

• To help ensure external accountability, NOAA is the first agency to commit to reporting annual aggregate statistics of scientific integrity misconduct cases (Section 10-04).
• The policy gives scientists the right to review and correct official documents that cite or reference their research (Section 7.01, second bullet). This makes it more difficult for anyone at the agency to misrepresent NOAA scientists’ research—whether intentionally or unintentionally.
• NOAA scientists now have the explicit right to express their personal views on any topic as long as they include a disclaimer stating that their views do not reflect those of NOAA or the Department of Commerce (Section 4.06).
• The professional biographical information for federal advisory committee members and federal advisory committee conflict-of-interest waivers will be made publicly available, except when the law prohibits disclosure (Section 7.01, third bullet).
• NOAA will provide its employees with timely and regular training regarding the new policy (Section 4.10) and will maintain a centralized “Scientific Integrity Commons” website where all can learn about and follow the department’s scientific integrity efforts.

The policy also tasks the NOAA Research Council with developing a “NOAA-wide framework for peer review and approval of Fundamental Research Communications” (Section 7.04) – agency speak for “media policy.” There is no timeline for the development of this policy, and I hope the agency will make this a priority.

Broader challenges remain

There are still a few areas of concern, however, that the policy does not fully address—partially because it will take greater leadership outside the agency to create meaningful change. First, the NOAA policy stipulates that “the scientific and technological findings, conclusions, and methodologies considered or relied on in policy decisions will be made available to the public in a timely manner” (Section 7, fifth bullet). What matters here is that this transparency is used to protect the scientific information when it leaves the agency, especially as the basis for a regulation or for other interagency review.

Interagency review is typically a White House-coordinated process that allows other agencies to weigh in on proposed NOAA policies and regulations. In the past, the White House Office of Management and Budget has misused this process and changed peer-reviewed scientific documents to support policy decisions it wished to put forward. The White House needs to figure out a way to protect all scientific documents as they move through the interagency review process. This does not mean releasing deliberative policy documents, but should include giving the agencies the ability to release the peer-reviewed research it used to develop a policy proposal before the interagency review process begins.

Second, with regard to whistleblower protections, NOAA officials can reinforce and repeat their statement that those who report political interference in science will be protected from retaliation. But Congress needs to pass and the president needs to sign legislation that gives these worker protections more teeth.

And finally, the policy fails to address whether NOAA leadership will take steps towards a system of releasing visitor logs such as making their calendars available to the public so we can better understand who is trying to influence agency decision-making. The White House should instruct all agencies to follow its lead and release their visitor logs.

It’s as simple as this: lawmakers and some presidential candidates who have long wanted to gut the Clean Air Act, the Endangered Species Act, and other critical science-based laws are taking advantage of fear about the economy. In a rush to take away public protections related to issues as diverse as food safety and toxic chemicals, they are frothing at the mouth, making emotionally compelling yet intellectually bankrupt arguments.

The White House has bent over backwards to get rid of unnecessary red tape. But President Obama and Congress should ask the question that Stanford economics professor Roger Noll asks in the article: “On balance, does our society benefit?”

Regulation grounded in independent scientific analysis has removed lead from paint and gasoline, led to more fuel-efficient cars, and protected workers from asbestos poisoning. At the same time, a lack of sensible regulation and enforcement led to the BP oil spill, the mortgage crisis, and the death of coal miners in West Virginia.
“I reject the idea that we need to ask people to choose between their jobs and their safety,” said President Obama in his speech to Congress introducing the American Jobs Act. “I reject the argument that says for the economy to grow, we have to roll back protections that ban hidden fees by credit card companies, or rules that keep our kids from being exposed to mercury, or laws that prevent the health insurance industry from shortchanging patients…We shouldn’t be in a race to the bottom, where we try to offer the cheapest labor and the worst pollution standards.  America should be in a race to the top.  And I believe we can win that race.”

Unfortunately, it seems that some legislators and candidates do not share that conviction. They need to stop scaring people and tackle the real, not imaginary, causes of the economic downturn while preserving our nation’s legacy of safeguarding its citizenry.

Given the fact that this deadline is one year to the day after Dr. Holdren issued guidelines that required agencies and departments to develop these policies, the public should expect the policies to be specific and comprehensive.

To date, some agencies have provided more specifics than others. For example, the National Science Foundation included language in its draft policy that reaffirms the right of its staff to communicate effectively with reporters; in contrast, the Department of Interior included vague language in its policy and then promised to update its media policy. Nearly a year later, we’re still waiting for that to happen. (I’ll have more to say on media policies later in the week).

In a notably positive development, the blog post also recommended that agencies make drafts available for public comment. “Our experience with agencies that have already done so has been that draft policies tend to improve considerably as a result of public input,” wrote Dr. Holdren.

I am encouraged by the fact that the White House has recognized the importance of external input to policy development. Only five agencies thus far have sought public comment on policy drafts: Interior, NSF, EPA, NASA, and NOAA. The comment period for USDA’s incomplete and potentially ineffective draft policy closed just yesterday (you can read our comments to USDA here).

The post came just two days before a meeting of the President’s Council of Advisors on Science and Technology at which several scientists are expected to testify about the importance of continued progress in restoring scientific integrity to federal policymaking.

Over the past several months, UCS staff have met with leaders of many agencies to give input on scientific integrity policy development. We’ve also published a suite of resources for agency staff to use as they work to meet the White House scientific integrity guidelines.

If the administration expects policies to be fully implemented by the end of 2012, the policies that agencies release by December 17 must be ready for prime time. Agencies should not wait for this deadline to release policies for public comment. And the White House must rapidly share what comes in so we don’t lose momentum and visibility during the holiday season.

I look forward to seeing more policies over the next few weeks and will continue to share my views regarding their strengths and weaknesses.