The Project On Government Oversight (POGO) Blog

Un-Do Influence: Obama's Lobbyist Ban is Tough (Except When It Isn't)

Facepalm Ratings Guide = Stupefying example of everything that's wrong with the system. = Outrageous; shameless, even. = Worthy of rebuke. = Even if there's no conflict of interest, appearances matter.

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By JOE NEWMAN

For a guy who likes to talk about keeping lobbyists out of his administration, President Barack Obama sure doesn't mind making some notable exceptions.

Now comes the latest dust-up involving Vice President Joe Biden's hiring of Steve Ricchetti to be a senior advisor. That's the same Steve Ricchetti whom the Obama campaign in 2008 attacked for being a lobbyist/bundler for then Sen. Hillary Clinton.

Listening to the administration spin the hire is pretty funny. Ricchetti hasn't personally lobbied since 2008. What was he doing instead? He was running his, um, lobbying(!) firm.

Obama has taken legitimate and laudable steps to slow the revolving door between lobbying firms and the White House and reduce private interests' disproportionate influence on executive branch policymakers. The restrictions he passed upon taking office were unprecedented, and intended to reduce industry influence peddling. 

But then there are those waivers and exceptions. Those are fine by us if they're used to bring public interest lobbyists into the fold. Not so much when they're granted to, say, a lobbyist for a top defense contractor. 

Look, lobbying, per se, isn't a bad thing. There's a place in our democracy for it—citizens, and that includes those paid to represent special interests, have a right to directly petition their elected leaders.

But one only has to look to Jack Abramoff to see how the system can be corrupted when lobbyists with access to piles of cash are able to buy influence through gifts, perks, campaign contributions and in the worst cases—bribes.

President Obama was right to want to distance himself from their influence. But if you're going to talk the talk, you've got to expect to some flak when you (or your vice president) bend your own rules. Sorry, Mr. President, the buck stops with you—you and Vice President Biden earned four facepalms.

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Penn's Awkward Silence on Academic Integrity

Researcher Reprimanded for Ghostwriting...What about All the Others?

By PAUL THACKER

We have been hounding the issue of medical ghostwriting for the last couple of months, and to keep interested parties informed, we created an FAQ on medical ghostwriting . Unfortunately, the FAQ contains an error.

I've pointed out before that it is extremely hypocritical that universities punish undergrads and grads for plagiarism, but look the other way when professors steal the words of ghostwriters to publish studies favorable to industry and expand their own bloated CVs.

Universities regularly give failing grades and even expel students who use paper mills for classroom work, but not a single professor has been punished over allegations of ghostwriting, despite scandals at over a dozen schools .

I was wrong.

Last week, The Montreal Gazette reported that McGill University formally reprimanded professor Barbara Sherwin for failing to mention help from a ghostwriter hired by Wyeth Pharmaceuticals to write a paper published in 2000. The story added that Dr. Sherwin is no longer a member of the Quebec Order of Psychologists, which means she can no longer practice under the title of psychologist.

So we’ve updated the FAQ .

Interestingly, the reprimand from McGill was previously reported by Canada’s national weekly current affairs magazine, Macleans. The story was long, and I missed the reference to the reprimand which was written about eleven paragraphs into the article.  In her defense, Dr. Sherwin stated that she was not “sanctioned.”

Which raises the question, “What is the difference between a reprimand and a sanction?”

Paul Thacker is a POGO Investigator.

Chair of Obama's Bioethics Commission Ignores Ghostwriting on Her Own Campus

By PAUL THACKER

Yesterday, POGO sent a letter to President Obama asking that Dr. Amy Gutmann be removed as chair of the commission that advises the President on bioethics. We did so because Dr. Gutmann has ignored serious allegations of research misconduct regarding a senior professor at the University of Pennsylvania, where she is President.

If Dr. Gutmann cannot deal with bioethical concerns on her own campus, with her own faculty, then how can taxpayers trust her to advise the President of the United States?

Quite frankly, I don’t have a clue.

Here are the facts. Last November, POGO sent a letter to Dr. Francis Collins at the National Institutes of Health about four cases where federally funded researchers used a ghostwriting company paid by GlaxoSmithKline (GSK) to write manuscripts that were favorable to Paxil, an antidepressant sold by GSK.

According to documents we included with the letter, GSK apparently paid a ghostwriter to write a scientific editorial for a medical journal with the byline of Dr. Dwight Evans, Chairman of the Department of Psychiatry at the University of Pennsylvania School of Medicine.

Frequently Asked Questions on Ghostwriting for Experts, Reporters, and Laymen

By PAUL THACKER

With the gracious help of several scholars, POGO has assembled an FAQ on corporate-funded medical ghostwriting. We hope this will answer any questions you might have on this very disturbing practice that corrupts the medical literature, drives up healthcare costs, and puts patient safety at risk.

Read it here: Frequently Asked Questions about Medical Ghostwriting

We’d like to thank the following academics for their help on this project:

• Trudo Lemmens, Professor of Law, University of Toronto
• David Healey, Professor in Psychological Medicine, Cardiff University School of Medicine, Wales
• Adriane Fugh-Berman, Associate Professor of Family Medicine, Georgetown University School of Medicine
• Leemon McHenry, Lecturer in Philosophy, California State University-Northridge

Enjoy.  And feel free to offer any other suggestions in the comments section of our blog.

Paul Thacker is a POGO Investigator.

Image: oddsock.

POGO Ghostwriting Records Added to Drug Industry Documents Archive at UCSF

By PAUL THACKER

Over 290 documents uncovered by POGO during a ghostwriting investigation have been added to the Drug Industry Document Archive (DIDA), an online library of pharmaceutical documents housed at the University of California-San Francisco. The DIDA library was created in 2005 to help investigators and scholars comb internal corporate documents from large pharmaceutical companies.

These documents have revealed alarming practices by the drug industry, including questionable clinical trials and corrupt relations with doctors.

POGO sent the documents to UCSF after referencing them in a letter to the National Institutes of Health, asking that the agency stop funding academics involved in ghostwriting. The documents became public after they were dedesignated during litigation involving Paxil, an antidepressant sold by GlaxoSmithKline.

The DIDA library grew out of a concept established at UCSF called the Legacy Tobacco Documents Library, an online database of over 13 million documents made public by the tobacco companies as part of their settlement with the federal government.

These documents are searchable and have proven critical for investigators trying to uncover corrupt activity by Big Tobacco. For instance, in a fit of insomnia in 2005, I was trolling through the archive late one night and found a Phillip Morris budget document with a line item for payment of $92,500 to Steven J. Milloy, who was the science columnist for FoxNews.com.

How Scientific Literature Has Become Part of Big Pharma's Marketing Machine and How Being Nice Hurts Canada: 5 Questions with Ghostwriting Expert Trudo Lemmens

By PAUL THACKER

In 2005, Trudo Lemmens and a colleague wrote "Ethics for Sale," an article in Slate that ripped the bandage off the sordid underbelly of human clinical trials in the United States.

"If you missed the movie The Constant Gardener and need your fix of moral outrage, you don't have to go to Africa to find it," they wrote.

The article caught the attention of editors over at the journal PLoS Medicine, who invited Lemmens and his co-author, bioethicist Carl Elliott, to publish a written debate against Ezekiel "Zeke" Emanuel, a government bioethicist who is the brother of Rahm Emanuel and was a close advisor to President Obama on healthcare issues.

The topic? Research ethics.

"We crushed him, because we were right and he was wrong," says Dr. Elliott, a professor at the University of Minnesota. "You can always depend on Zeke to give the industry perspective."

Not a physician, Lemmens is a professor of law at the University of Toronto. After law school, he did a master’s degree and then a doctorate in law at McGill University, where he examined genetic discrimination. In his spare time, he delved into the ethics of clinical trial research.

Mr. Lemmens then published papers on ethics in human research, conflicts of interest in medicine, and on restoring scientific credibility to commercial research. In "Leopards in the Temple," he argued that pharmaceutical research regulations have failed to protect patients' interests, and that our broken system must be replaced by an independent drug testing agency.

Last month, he brought together a host of experts for the first international meeting on corporate-funded ghostwriting in medicine. POGO caught up with Mr. Lemmens recently to ask him a few questions about ghostwriting—find his edited responses below.

POGO: Why did you decide to hold a conference on ghostwriting and how does ghostwriting affect average citizens?

Trudo Lemmens: I've worked for some time on various overlapping regulatory tools—from soft research ethics and conflicts of interest guidelines, to hard regulations such as Food and Drug Acts—and how they fail to deal with the over-consumption of pharmaceuticals and their adverse effects. It’s one of the major health challenges we face in health care in the industrialized world.

Author of Ghostwritten Study Runs for Parliament in Canada

By Paul Thacker

The night before I spoke last week at the University of Toronto conference on corporate funded ghostwriting in medicine, the university held a dinner at a French bistro for the conference speakers. It was election night in Canada and everyone at the table was buzzing about Dr. Stan Kutcher, a psychiatry professor at Dalhousie University who was running for Parliament.

Under legal threat from Dr. Kutcher, The Coast, a small Canadian newspaper, retracted and then apologized for a story that investigated a study Dr. Kutcher published on Paxil. Known as "Study 329," this clinical trial was funded by GlaxoSmithKline (GSK) and concluded that Paxil is "generally well tolerated and effective for major depression in adolescents."

Unfortunately for Dr. Kutcher, GSK was sued in the United States for hiding evidence of the link between Paxil and suicide. Numerous internal emails and documents are public and Study 329 now pops up in most discussion whenever experts talk about corruption in medical research.

Ghostwriting Raises Global Alarm and Undermines the Supreme Court!?

By Paul Thacker

The University of Toronto Law School and Joint Centre for Bioethics are hosting the first international seminar on ghost authorship in biomedical research this morning. Unfortunately, there is no webcast, but you catch the agenda here, and read some of the papers being discussed on this page.

I’m on the first panel to discuss the Senate Finance Committee’s ghostwriting report, which Senator Charles Grassley (R-IA) released last summer (full disclosure: while working as a staffer for Senator Grassley, I helped put this report together).

Before I begin, allow me to digress and discuss today’s New York Times front-page scoop about Justice Clarence Thomas being caught with a Supreme Court opinion ghostwritten for him by attorneys at Goldman Sachs. The case involves a lawsuit brought by shareholders against Goldman executives for hiding financial loss information in the months leading up to the 2008 stock market crash.

Kind of an amazing story. According to drafts and emails obtained by the Times, Goldman attorneys wrote “entire passages and tinkered with sentences in the opinion summary to slant language in favor of Goldman executives and against shareholders.”

Wow. Pretty stunning. Especially since it isn’t true.

FOIA Friday: The NIH Reacts to "Show Me the Money!" Researcher

By Paul Thacker

This week’s document: A letter sent to Emory University expressing concerns about the conflicts of interest and “independence and objectivity” of Dr. Zachary Stowe, Professor of Psychiatry & Behavioral Sciences and Director of the Women’s Mental Health Program at Emory University School of Medicine.

Agency: National Institutes of Health (NIH).

Context: The NIH sent Emory this letter in July 2009 after the media exposed Dr. Zachary Stowe’s cozy financial relationship with GlaxoSmithKline (GSK) while also receiving NIH grants to study antidepressants like GSK’s Paxil in pregnant women.

Language here is important.

The NIH initially discusses Dr. Stowe’s “conflicts” as perceived, which is how this matter is normally expressed. Whenever talking about financial conflicts of interest, government officials regularly soften their language with descriptors like “apparent,” “potential,” or “possible.”  In reality, these words complicate the obvious: academic physicians are being bought off by corporations.

You're Fired: Forest Lab's CEO May Be Banned from Federal Healthcare

By Paul Thacker

As reported at Pharmalot, the CEO of Forest Laboratories received an unfortunate letter last week, demanding that he explain within 30 days why he should not be excluded from participation in federal healthcare programs. Banning Mr. Howard Solomon would prevent Forest from billing the government—every pharma company’s largest customer—and effectively end his over thirty-year tenure as CEO.

The company’s board expressed shock.

“It would be completely unwarranted to exclude a senior executive against whom there has never been any allegation of wrongdoing whatsoever,” said board member William J. Candee III, in a Forest statement. “Mr. Solomon has always set a tone of the highest integrity from the top.”

Oh, really?

Why Get Spooked by a Little Ol' Ghost? The Story of Pfizer, 16 Year-Old Dustin Yankus, and Whistleblower David Franklin

By Paul Thacker

The American Psychiatric Association has been reeling for over a week from allegations regarding ghostwriting and a textbook they published some years ago with help from Scientific Therapeutics Information. GlaxoSmithKline paid for the book, which one critic now calls “an advertisement for Paxil.”

POGO has released several documents including a draft of the book’s text, a timeline for completing the book, and the deposition of ghostwriter Sally Laden.

Still, some may wonder, “So what? Why should I care about ghostwriting?”

Consider Dustin Yankus, a teenager who was diagnosed with bipolar disorder in 2001. To control his condition, Dustin’s doctors gave him Neurontin, an anticonvulsant taken by epileptics.

American Psychiatric Association Stunned Again with Ghostwriting Controversy

By Paul Thacker

Like an aging, punch drunk fighter struggling through the twelfth round, the American Psychiatric Association (APA) can’t seem to slip the punches coming its direction. Last week, a host of blogs went after them for refusing to print a letter written by three academics that was critical of a medical textbook the APA published with help from the ghostwriting company Scientific Therapeutics Information (STI).

The letter criticized the APA for failing to publish records that explain the provenance of the textbook, including drafts, contracts with STI and/or GlaxoSmithKline, and any communications regarding editing. The text’s purported authors are Dr. Charles Nemeroff of the University of Miami and Dr. Alan Schatzberg of Stanford University.

As The New York Times reported, the textbook was funded by GlaxoSmithKline. Author and blogger Dr. Danny Carlat reviewed the book and wrote that it read like “an advertisement for Paxil.” 

Yesterday, Phyllis Vine over at MIWatch landed a blistering combination on the APA. When she poked them for a response, the APA covered up and peeked back through their gloves. “The APA's official response has been unconvincing,” she jabbed.

She then landed a solid uppercut.