POGO and Partners Oppose House Bill That Allows FDA More Secrecy

The Project On Government Oversight has;

POGO and Partners Oppose House Bill That Allows FDA More Secrecy

May 29, 2012

Chairman Fred Upton

House Energy and Commerce Committee
2125 Rayburn House Office Building
Washington, DC 20515

Ranking Member Henry Waxman
House Energy and Commerce Committee
2322A Rayburn House Office Building
Washington, DC 20515

Dear Chairman Upton and Ranking Member Waxman:

The undersigned organizations concerned with openness and accountability are writing to urge you to remove or substantially narrow a provision of H.R. 5651, the Food and Drug Administration Reform Act of 2012, that needlessly prevents the public from having access to potentially important health and safety information and that could greatly diminish the public’s access to information about the work of the U.S. Food and Drug Administration (FDA).

Section 812 of H.R. 5651 allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local, or foreign government agency, if the agency has requested that the information be kept confidential. As introduced, Section 708 of S. 3187, the Food and Drug Administration Safety and Innovation Act, contained similar language. The Senate accepted an amendment to the provision offered by Senator Leahy (D-VT) that limits the scope to information voluntarily provided by foreign governments, requires that the request to keep the information confidential be in writing, and, unless otherwise agreed upon, specifies a time frame after which the information will no longer be treated as confidential.

We understand that Congress intends the language to promote the sharing of drug inspection information by foreign governments with the FDA. However, the FDA does not need this authority because the Freedom of Information Act (FOIA) already provides exemptions to protect against the release of many law enforcement records; confidential, commercial information; and trade secrets.

At the very least, section 812 should be narrowly tailored to avoid unintentionally or unnecessarily increasing secrecy at the FDA.  The provision currently covers information obtained from other federal agencies, which are themselves subject to FOIA, and information obtained from state and local agencies, despite an FDA regulation that specifically protects from disclosure many records submitted to FDA by those agencies.   Furthermore, the provision is written so broadly that it could include information that now is required to be disclosed to the FDA, restricting the public's right to know about potential health and safety risks.

We urge you to address this problem before H.R. 5651 is brought to the floor for a vote and to work with the conference committee to ensure that section 812 is either removed or, at a minimum, substantially narrowed to protect the public’s right to critical health and safety information. Representatives from the undersigned organizations are willing to discuss possible ways to address these issues. If you would like to discuss these issues further, please contact Patrice McDermott, Executive Director of OpenTheGovernment.org, at 202-332-6736 or pmcdermott@openthegovernment.org.

Sincerely,

American Booksellers Foundation for Free Expression

American Library Association

American Society of News Editors

Association of Research Libraries

Center for Media and Democracy

Citizens for Responsibility and Ethics in Washington – CREW

Essential Information

Freedom of Information Center at the Missouri School of Journalism

iSolon.org

Mississippi Center for Freedom of Information

National Coalition Against Censorship

National Freedom of Information Coalition

National Priorities Project

OMB Watch

OpenTheGovernment.org

Progressive Librarians Guild

Project On Government Oversight – POGO

Public Citizen

Sunlight Foundation

Tully Center for Free Speech at Syracuse University

Washington Coalition for Open Government

cc: Food and Drug Administration Commissioner Margaret Hamburg

      Chairman Tom Harkin, Senate Committee on Health, Education, Labor & Pensions

      Ranking Member Michael Enzi, Senate Committee on Health, Education, Labor & Pensions

      Chairman Joe Pitts, House Energy and Commerce Subcommittee on Health

      Ranking Member Frank Pallone, House Energy and Commerce Subcommittee on Health

      Senator Patrick Leahy

      Representative John Dingel

The National Institutes of Health New Ethics Rules: A Swing and a Miss

The Project On Government Oversight has;

The National Institutes of Health New Ethics Rules: A Swing and a Miss

By PAUL THACKER and NED FEDER

After almost four years of horrible press over medical research tainted by conflicts of interest, the National Institutes of Health (NIH) was presented with a great opportunity to make fundamental changes to their rules, increase transparency, and strengthen public trust in taxpayer-funded research.

Instead, they stepped up to the plate...assumed a power stance...and struck out.

The NIH released its final rule today, and gone are the provisions that would’ve injected some much-needed transparency into taxpayer funded research.

Here’s how they could’ve written the rule to hit a home run:

Before disbursing federal funds to an academic researcher, the university must disclose that researcher’s outside income and a plan to manage the researcher’s conflicts of interest. Both the outside income and the management plan will be posted on the NIH RePORTER website, which details other information about the grant.

It’s just that simple and cheap. Because the NIH RePORTER website already exists.

Instead of being able to access the information easily online, taxpayers will have to write to universities and ask them about the professor’s conflicts of interest. Imagine if you had to write to your politician to ask who he takes money from, instead of viewing it on publicly available websites.

Are America’s professors scared to meet the ethical standards of elected politicians?

Furthermore, the universities’ conflict of interest management plans will remain hidden. You're not allowed to see them. Why? It doesn’t make any sense.

Finally, there are no changes to the penalties, one NIH official said in today’s phone briefing, because the previous rules had “strong enforcement.” Please.

The only reason NIH was forced to make these changes is because Senator Charles Grassley (R-IA) dogged them for years about lax enforcement, with embarrassing stories in the media about Drs. Charles Nemeroff, Alan Schatzberg, andJoseph Biederman, among others.

When a United States Senator has to put on his work boots and do an agency’s job, that doesn’t meet taxpayer expectations.

We should have gotten something to be proud of. We should have expected this administration to swing for the fences—especially given its early promises of transparency.

Paul Thacker is a POGO Investigator. Ned Feder is POGO's Staff Scientist.

Image via Boston Public Library.

"Are America’s professors scared to meet the ethical standards of elected politicians?"

ROTFLMAO

"The only time a man's life, liberty, and property are safe is when the legislature's not in session."

Mark Twain

Thank You POGO and Mr. Thacker

POGO Hits FDA With Clue Stick Over COI Regs For Panelists

The FDA wants to loosen its (Financial) Conflict Of Interest rules in order to Further Infest its drug advisory panels with people who are - how can we put this delicately - Already Bought & Paid for Mouthpieces of the Pharmaceutical Industry: claiming that they can't even Find qualified people who aren't Whoring for Pharma.

Government Watchdog (& former Investigator for Senator Grassley) Paul Thacker finds that proposition ludicrous, & fires this delicious rocket at them.

The Project On Government Oversight has;

FDA's Janet Woodcock: Miss Piñata Meets Clue Stick

By PAUL THACKER

Oh, the vagaries of a hot Washington summer. Between the heat, humidity and mosquitoes is it any wonder that we gather friends and family and head for the beach to escape the city's oppression?

If Dr. Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research (CDER), leaves the District to summer on the shore, my guess is her beach rental will be packed with drug industry executives. These days, it seems like some of Janet's closest buddies are the boys and girls at Big Pharma.

To FDA insiders, she’s one of their most ardent advocates, particularly when it comes to conflict of interest standards for FDA advisory board members. And so yesterday, POGO sent a letter to FDA Commissioner Margaret Hamburg urging her not to weaken the agency’s conflict of interest standards, by focusing on facts and not what appears to be Dr. Woodcock’s personal opinions.

Even before Obama stepped foot in the White House, the drug industry began floating Dr. Woodcock’s name for FDA Commissioner in the pages of The Wall Street Journal. This vexed Congressman Bart Stupak (D-MI) who sent the President-elect an angry letter.

"Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for,” Stupak wrote, without naming Dr. Woodcock directly.

In recent months, Janet has been blowing kisses back to drug executives who are irritated that new conflict of interest rules are limiting their ability to place their paid-for experts on FDA’s safety panels. Last May, she told reporters that financial conflict of interest rules made it "tough to find knowledgeable people" to serve on advisory panels that make recommendations on drug safety.

"It's a concern for all our staff," she said.

At a hearing in early July, she repeated industry talking points when asked if finding experts with no ties to industry was causing a “time lag” in drug approval.

Yes, it is true. It is also true we have difficulty recruiting qualified people and having highly qualified panels, and in some cases we've had to delay advisory committees because the difficulty of…because once we go through, in great detail, all the financials of the individuals we've nominated, we find that they have to be excused from participating.

So what? you might ask. Who cares what Dr. Woodcock thinks?

The problem is that Janet plays Rasputin to FDA Commissioner Margaret Hamburg, often bending the Commish’s ear to whisper ideas on how to run the agency. So it comes as no surprise that Dr. Hamburg has begun parroting the industry’s—er, Janet’s—talking points.

A couple of weeks ago, Dr. Hamburg said that “valid concerns” have been raised about conflicts of interest rules, prompting an agency review.

Not so fast. The facts, at this time, don’t support any rules “review.” If anything, this looks like a clever move by Dr. Woodcock to create a “problem” that exists not at the FDA, but in the boardrooms of Big Pharma.

Because Dr. Woodcock’s thinking has been wrongheaded and muddled for so many reasons, I’m going to defer to one of my favorite bloggers, Tim Lambert. He’s an Australian computer scientist who writes at ScienceBlogs.

When frustrated with a particularly intransigent individual, for whom facts and logic don’t seem to matter, he likes to hoist them up a rope, much like a piñata, and start whacking away with a “clue stick.”

Why a clue stick? Because when logic and facts fail, your only defense against the obtuse barbarians is to whack away until your arm grows tired. You may not change anything, dear reader, but the clue stick produces tasty nuggets of stupid.

Release Woodcock Piñata, Grab Your Clue Stick

The law allows FDA to grant waivers for conflicted experts who serve on advisory boards. The cap is set at 13 percent, yet the agency has never allowed more than 5 percent of a committee’s members to have a waiver.

Hmmmm... If there are still plenty of waivers to hand out, then why is Janet making such a big deal?

Good question. I don’t know. I think Janet is ready for the clue stick.

*WHACK!*

Second, FDA’s own data finds that the vacancy rate for advisory members continues to fall every year. That means FDA is getting better and better at locating outside experts for advice.

Gentle reader—are you wondering, Um, rules are always hard to follow at first, until you get the hang of it. So why is Janet making such a big deal…?

Again, I’m like you. Confused. Should we discuss further...or clue stick?

*WHACK!*

Third, a federally funded study of 2914 academics by Harvard University’s Eric Campbell finds that almost 50 percent of research academics have no ties to industry. That’s right, ZERO financial conflicts. Dr. Campbell published his data in the journal Health Affairs and discussed it last June at a Georgetown University conference.

Oh, approximately one third of these researchers are full professors.

Dancing through your head may be something like, Well, if all these experts are out there, why won’t FDA use them? I’m getting a little irritated.

Yep. I’m irritated too. You want the clue stick this time?

*WHACK!!!*

Nice job.

Fourth, a study in the Archives of Internal Medicine looked at participants who put together clinical care guidelines for cardiology. These guidelines help your personal cardiologist know how to treat you. Yet, the study found that 44 percent of the experts putting together the guidelines had no financial conflicts of interest. Again. ZERO!!!

Paul, I’m really...I’m somewhat...I’m beyond irritated now. Hand me the clue stick! Give it to me now!

*WHACK!!!*

Whoa. Calm down.

Fifth, while Janet and her staff at FDA can’t find qualified researchers without ties to industry, journalists Shannon Brownlee and Jeanne Lenzer had no problems. Three years ago they organized a list of 100 medical experts with no corporate ties and published it in the British Medical Journal.

Now, some of these experts probably would not qualify to serve on advisory boards, but many of them obviously could. So if two reporters on a freelance budget can assemble such a list, why can’t Janet?

Give me the stick!!! I’m going to make it rain golden buckets of stupid!!!

*WHACK!!!*

*WHACK!!!*

*WHACK!!!*

Glad that’s over . . . You really need to take it easy.

Piñata is supposed to be fun.

FYI, Shannon Brownlee and Jeanne Lenzer sent their own letter to Dr. Hamburg yesterday expressing “dismay” that the agency is attempting to loosen conflict of interest rules because they can’t find qualified experts. To help the agency get its act together, they attached a list of qualified experts.

Paul Thacker is a POGO Investigator. Image above by Flickr user pareeerica. Image below: roo murdock.

Thank You POGO and Mr. Thacker

POGO Tells APA "We STILL Ain't Buying It!"

2 Psychiatric KOLs - Charles Nemeroff and Alan Schatzberg - have their names attached to a textbook which attracted the Project On Government Oversight's attention, as their level of involvement in the book's scripting opened an ugly can of Ghost Writers. See backstory here & here.

The PLoS also has a Very distressing look into the commercialization/corruption of Academic Medical Research by Dr. Rent a Names.

Ghostwriting At Elite Academic Medical Centers In The United States

the Project On Government Oversight has delivered the following letter;

http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html (complete letter link at page bottom)

28 January 2011

Carolyn B. Robinowitz

Interim Editor,

Psychiatric News

Letter to Editor

Text’s Provenance Remains in Dispute

Writing for the American Psychiatric Association (APA), Mark Moran claimed “APPI Documents Refute Claims About Text’s Authorship” (Psychiatric News 21 January 2011; Vol 46/2, p.1). The nominal authors of the book (Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care) are Charles Nemeroff and Alan Schatzberg. We remain unconvinced of their authorship, for the following reasons. Mr. Moran quoted another APA spokesperson, Mr. Ron McMillen, to the effect that Drs. Nemeroff and Schatzberg were actively involved “in every stage of the book’s development.” Note, however, that he did not venture to say they wrote the initial drafts – or indeed any drafts.

The released 49-page sample chapter draft provided by Diane Coniglio and Sally Laden, employees of Scientific Therapeutics Information, Inc (STI), is largely reproduced verbatim in the Handbook. That there are drafts with the nominal authors’ margin notes does not establish who actually wrote the Handbook. It is standard procedure for the ghostwriting company, Scientific Therapeutics Information (STI), to provide initial drafts that are reviewed by the contracting corporation (here, SmithKlineBeecham, now GlaxoSmithKline - GSK) before being released to the nominal authors.

STI is a commercial service entity, not a scientific institute. Their stated mission is to maximize credibility for their clients’ products. It is, therefore, no surprise that efforts to reach STI by Psychiatric News were not successful. The APA’s spokespersons, Dr. James Scully and Mr. Ron McMillen, quoted in Mr. Moran’s article, have reached premature closure based on limited evidence. To bring into full view the most significant evidence for this debate would require dedesignation of numerous confidential documents from both GSK and STI, as part of Paxil litigation. GSK, however, regularly invokes the Trade Secrets Act to ensure that the documents remain confidential and that their key opinion leaders are protected from exposure.

Finally, we take issue with the claim in Mr. Moran’s article that Drs. Nemeroff and Schatzberg “were not remunerated by GSK for any of this work.” Note that there is no mention of any indirect payments they may have received through the “unrestricted educational grant” to STI. Such arrangements are quite common.

We call on the APA/APPI to release all the key documents. The contract between STI and GSK will reveal how much influence GSK had on the content and tone of the book, and the role of GSK in approving drafts. Correspondence between Drs. Nemeroff and Schatzberg and STI will make it clear whether they followed the contract. Transparency also requires release of any GSK marketing/ business plans for the Handbook; the legal release form transferring ownership from GSK to the ‘authors’ and APPI; marketing activities of GSK sales representatives detailing the Handbook; and correspondence among all parties regarding the “unrestricted” educational grant.

This case highlights the need for disclosure if we ever are to understand the scale of corporate influence on academic publishing. We look forward to Congressional action to require the release of these documents.

Bernard Carroll, M.B., Ph.D.
Professor and Chairman Emeritus
Department of Psychiatry and Behavioral Sciences
Duke University Medical Center
Durham, NC 27710
E-mail bcarroll@duke.edu or bcarroll@redshift.com
Telephone 831-626-1467

Robert T. Rubin, M.D., Ph.D. * Dr. Rubin is corresponding author.*
Distinguished Professor and Vice Chair
Department of Psychiatry and Biobehavioral Sciences
David Geffen School of Medicine at UCLA
Los Angeles, CA 90073
Distinguished Life Fellow
American Psychiatric Association
E-mail robert.rubin@va.gov
Telephone 310-268-3319

Leemon B. McHenry, Ph.D.
Department of Philosophy
California State University, Northridge
Northridge, CA 91330-8253
E-mail leemon.mchenry@csun.edu

Dr Bernard Carroll has further thoughts on the matter at:

Health Care Renewal, WHO YOU GONNA BELIEVE?

as does Allison Bass: Government Oversight Agency Calls On NIH To Ban Ghostwriting

and 1 Boring Old Man: When Charlie Met Sally

and Ed Silverman: American Psychiatric Association And Ghostwriting

Our take remains that Trade Association Denials, Ghost Writers, Drug Company payments - disclosed or not - Psychiatry has never cured Jack and Is never Going to cure Jack because it cannot biologically prove that Jack even exists.

The money this disability peddling gibberish is soaking us for is a large part of Why we Finally got sucker punched into surrendering another 6th of our economy to collectivist politicians. America is drowning in a sea of Therapeutic Incompetents who have Nothing to sell but Labels and Brain Eating Drugs.

Unless we stop Lobotomizing ourselves with Psychiatry's noxious drugs, asinine theories, and even more asinine denials, we, meaning Western Civ, will cease to exist. We will expire in a liquifaction of collectivist gullible.

Risperdal won FDA approval on Dec 29 1993 and None of the Seance Scientists pushing it realized that the stuff was causing Diabetes, ..... even AFTER they received a false and misleading Dear Healthcare Provider Letter (see here) from the manufacturer addressing Exactly that issue a decade later in 2003.

It never occurred to these characters to ask Why they got that silly letter after they'd been selling Risperdal and Watching what it did to people, ..... for 10 years.

How intentionally blinkered do you have to be, as a State Licensed Physician, to miss something like Diabetes, ..... when it's Risperdal's 2nd most often FDA Reported Adverse Reaction out of 1,935 of them?