The Project On Government Oversight (POGO) Blog

POGO Questions Scientific Integrity Plans for Contractors and Grantees

DNA analyzers at the Department of Energy's Joint Genome Institute.

By ANDREW WYNER

Yesterday, POGO sent the Office of Science and Technology Policy (OSTP) a letter expressing its concern that many executive branch agencies' scientific integrity plans do not sufficiently hold federal contractors and grantees accountable for their work. Agencies created the scientific integrity plans in response to President Obama’s 2009 Memorandum on Scientific Integrity (SI Memo), and the plans outline standards for government-funded science, including conflict-of-interest, procedural, and transparency rules.

While a handful of plans address contractors and grantees, POGO found that at least fourteen do not sufficiently cover federal contractors or grantees. POGO hopes that OSTP, the office in charge of implementing the President’s SI Memo, will ensure agencies know that they will not be in compliance unless they strengthen the integrity of all science funded by taxpayer dollars.

POGO specifically articulated its concerns, using DOE as an example, in its letter to OSTP:

POGO Submits Recommendations for Improving DOE Scientific Integrity

DOE appropriates billions each year for research in labs like this one in Oak Ridge National Laboratory.

By DANA LIEBELSON

Late last week, POGO submitted a letter to the Department of Energy (DOE), urging the Department to strengthen its scientific integrity policies, make documents relating to allegations of scientific misconduct available to the public, and improve oversight of contractors' investigations of alleged misconduct by establishing an Office of Research Integrity (ORI).

A 2009 memorandum issued by President Obama asked government agencies and departments to come up with recommendations to improve “transparency in the preparation, identification and use of scientific and technological information in policymaking,” and submit them to the Office of Science and Technology Policy (OSTP). In a follow-up announcement on October 3, agencies and departments were asked to submit their final draft policies by December 17 for review by OSTP.

On December 16, DOE submitted its “draft final” plan on scientific integrity to OSTP. DOE told POGO it will now go through another round of revisions. While DOE did share its preliminary response to OSTP with POGO, which is essentially an inventory of their current scientific integrity policies, they have thus far not made the draft final plan public.

POGO joins the Union of Concerned Scientists in urging DOE and all other agencies to make their plans public, following the example of a handful of other departments and agencies. One of the areas in which POGO strongly recommends strengthening scientific integrity at DOE—and other departments and agencies—is in the oversight of contractors’ investigations of alleged research misconduct.  In its letter, POGO pressed DOE to strengthen its oversight and make the process more transparent.

Podcasts on Video: A Teaser of Our Talk with Bob Alvarez About Nuclear Fuel Rods

By ANDRE FRANCISCO

Here is a video teaser to get you excited about the podcast we posted yesterday with Bob Alvarez, a Senior Scholar at the Institute for Policy Studies (IPS). Listen to the whole podcast to hear exactly how bad things could get if the U.S. doesn't learn from the lessons of Fukushima and change how it stores spent nuclear fuel rods. You can read the full report released by IPS with support from POGO here and listen to the podcast here.

Like what you are seeing? Subscribe to our Youtube Channel to hear about all of our new videos. 

Andre Francisco is a POGO associate.

What's Happening: POGO's Paul Thacker on Medical Ghostwriting

By ANDRE FRANCISCO

On the blog we've been talking about this thing called medical ghostwriting. Never heard of it? Don't worry, POGO's Paul Thacker is here to explain what's happening.

Catch up on our medical ghostwriting blog posts and the letter we sent to President Obama about it.

Want more after watching the video? Read our FAQ about medical ghostwriting.

 Andre Francisco is a POGO Associate.

Ghostwriting controversy haunting the American Psychiatric Association

By Paul Thacker

The blogosphere lit up this morning with several posts on the American Psychiatric Association’s (APA) refusal to print a letter critical of a medical textbook they published with help from the ghostwriting company Scientific Therapeutics Information.

We covered it at POGO here, and Dr. Bernard Carroll wrote about it over at Health Care Renewal.  Dr. Carroll hints that other documents may throw more light on the controversial textbook.

documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not.

Author and journalism professor Alison Bass writes on her blog that APA’s refusal to publish the letter smacks of “censorship.”

How sad. Can it be that the APA is so fearful of its members' reactions (or more likely, legal threats by Nemeroff and Schatzberg) that it cannot even run a short and well-reasoned letter to the editor? For an organization that represents a profession whose very modus operandi is based on disclosure and transparency, the APA's track record of censorship and secrecy is unacceptable.

Meanwhile, Dr. Danny Carlat writes that the whole affair is like a bad penny that just won’t go away.

I don't think this issue is going away. It's time for the APA to prove to the world that they were not complicit with a drug company in publishing a "textbook" that artfully hid Paxil's side effects.

Ed Silverman has a wrap up piece over at Pharmalot, with links to all the blogs published thus far.  A reader named “Casper” commented at the end, “I loves the APA.”

On a more serious note, concern about ghostwriting has truly gone global.  Canada’s leading law school at the University of Toronto in conjunction with the university’s Centre for Ethics is hosting a one day conference on the topic in early May. 

The meeting is being organized by Associate Professor Trudo Lemmens and will feature an international panel of experts including myself from POGO, Carl Elliot from the U. of Minnesota, Adriane Fugh-Berman of Georgetown, David Healy from Cardiff, and David Korn of Harvard.

You can find the announcement and registration here, and the full agenda at this site.

Paul Thacker is a POGO investigator.

 

American Psychiatric Association Spooked about Ghostwriting

By Paul Thacker

When the New York Times raised ethical concerns about the American Psychiatric Association’s (APA) novel collaboration with a Big Pharma funded medical communications company to write a medical textbook, one would think the organization would go all out to rectify the situation. If you’re a creature of Washington, you know the drill:

First, deny culpability. 

Second, apologize for what you didn’t do. 

Third, announce new ethics rules, so that what didn’t happen will never happen again.

That’s typically how it works. But at APA and their publishing house, the APPI, brains seem to function differently from the rest of us.

Observing the APA try to bat away allegations of ghostwriting is like watching a silent slapstick where an actor trips on his own shoe laces and tries valiantly to maintain footing, before tumbling down a nearby flight of stairs, and dropping bottom first into an unfortunately positioned dirty mop bucket. 

Comedy genius.

DoD OIG: "Possible Sub-standard" Care of Service-members In Traumatic Brain Injury Research Trial

By Nick Schwellenbach

Yesterday afternoon, the Department of Defense Office of Inspector General (DoD OIG) posted: “Results in Brief: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq.” The results in brief confirm that a mild traumatic brain injury clinical trial (mTBI) in Iraq was “inconsistent with military standards for human subject medical research.” The two other findings by the OIG are that there was “possible sub-standard patient care” and “weaknesses in the process used to review and approve medical research in Iraq.” The assessment was completed on Thursday and the full “For Official Use Only” report is not publicly available, only the results in brief.

Despite the DoD OIG’s confirmation of misconduct, many questions remain, as evidenced by the DoD OIG’s numerous recommendations. The two recommendations that popped out at me were:

The Big Uneasy: Uncovering the Army Corps' Big Lie

Whistleblower Maria Garzino, POGO Executive Director Danielle Brian and Director Harry Shearer discuss Shearer's documentary The Big Uneasy

By Joe Newman

SILVER SPRING, MD. -- Director Harry Shearer offered a disclaimer to the AFI Silver theater audience Tuesday night before the screening of his documentary The Big Uneasy: They probably weren't going to be happy at the end of the movie.

But hopefully, Shearer said, they could have a good time not being happy.

Shearer didn't disappoint. The Big Uneasy makes you angry.The 90-minute long documentary -- which was shown during the Whistleblower Film Series sponsored annually by POGO and the DC Labor FilmFest -- details how the U.S. Army Corps of Engineers failed miserably to protect the people of New Orleans from Hurricane Katrina.

NIH Rules Miss Subtleties of Corporate Influence on Medical Research

By Paul D. Thacker 

POGO noted last week that the National Institutes of Health (NIH) is considering new rules to address the issue of corporate ghostwriting in medical literature.

Although NIH Director Dr. Francis Collins told POGO that his agency is "sending a clear message to institutions and investigators alike that we support the principles of transparency and accountability in research," a question remains. Do these rules go far enough?

As I explained to Nature, Dr. Collins continues to miss some subtleties regarding corporate-funded ghostwriting firms, like STI, and how they corrupt the medical literature.

Dr. Collins said that proposed NIH regs on conflicts of interest will require academics to disclose "paid authorship" when filing conflict of interest forms.

The National Institutes of Health NOT Friendly to Ghostwriting

By Paul D. Thacker

Late last year, POGO sent a letter to the National Institutes of Health (NIH) apprising them of four examples of academics who used the ghostwriting firm Scientific Therapeutics Information to publish studies, letters, and a book. POGO’s letter was covered by The New York Times, and Nature published an editorial excoriating the NIH for supporting researchers who fail to reveal their ties to industry.

Last week, NIH Director Dr. Francis Collins wrote to POGO explaining his agency’s take on financial conflicts of interest and ghostwriting in academia. Presidents and Deans of America’s medical schools take note: Dr. Collins wrote that the NIH “does not condone the practice of ghostwriting.” In fact, ghostwriting is banned at the NIH, and if federal funds are involved, Dr. Collins stated that ghostwriting could be referred to the Office of Research Integrity for an investigation as “a case of plagiarism.”

Dr. Collins also wrote that the NIH is considering ways to deal with ghostwriting in its newly proposed revision to rules on conflicts of interest in extramural funding:

Because of its potential to create conflicts-of-interest that could bias or otherwise inappropriately influence NIH-supported research, “paid authorship” was specifically included in the proposed revisions to the regulations. By including “paid authorship” in the definition of “Significant Financial Interest” in the proposed rule, the NIH is sending a clear message to institutions and investigators alike that we support the principles of transparency and accountability in research and that institutions and investigators engaging in such activity may be subject to more rigorous disclosure and reporting.

People. Pay attention. Time to give up the ghosts.

Read the NIH’s response to POGO’s letter.

Paul Thacker is a POGO Investigator.

Image by Flickr user LRobertas, used under Creative Commons License

Related:

• Ghostbusters at POGO
• POGO Letter to NIH on Ghostwriting Academics

Did the White House Put Public Relations Before Science in the Oil Spill Report?

By Bryan Rahija

POGO was hoping President Obama would touch on several key reform topics in last night's State of the Union address, but one that we were keeping a particularly watchful eye for was the issue of scientific integrity.

That's partly because POGO recently unearthed internal emails suggesting that the White House placed public relations over science in last year's controversial report on the oil spill, which in fact was referred to as a "communication product" internally, according to the emails.

The Ugly Underbelly of Medical Research

For today’s case study in maintaining the integrity of taxpayer-funded biomedical research, we launch ourselves 3,000 miles across the United States, to the leafy green campus of Stanford University, in sunny Palo Alto, California.

Isn’t the weather lovely?

Stanford maintains a web page devoted to its conflicts of interest policy and inquiries involving former department chairman Dr. Alan Schatzberg, who came under fire for his federally funded research of the drug mifepristone.  The web page has links to almost 20 different documents, including public statements, a letter to The New York Review of Books, and several letters to Senator Charles Grassley (R-IA) and the National Institutes of Health (NIH).

What’s missing, you might ask?

Well, how about any press statement or other documents announcing that an NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.

Why wouldn’t Stanford make this information publicly available online along with the numerous other documents?  The information certainly seems to be of interest to the public.

Emails recently unearthed by POGO reveal this untold twist in the story of the mifepristone clinical trial. But before we dive in, let’s wind back the clock to 2008, when Senator Grassley began investigating Dr. Schatzberg for alleged cozy ties to the pharmaceutical industry.

Full disclosure: I am a former Grassley staffer and was the lead investigator on the senator’s work on Dr. Schatzberg and mifepristone.