Big Door Keeps On Turning - Bi-Directional Interchanges Among Government and Corporate Health Care Leadership

Recently we noted some complex examples of the health care "revolving door," cases of health care corporate leaders who came from government heading back into government.  The first was reported by Politico:

California Rep. Mary Bono Mack has hired PhRMA’s former chief spokesman as a senior adviser, adding another Republican lawmaker to the list of those who have recruited staff members with K Street ties.

Ken Johnson will serve as a senior policy and communications adviser to Bono Mack, chairwoman of a House Energy and Commerce subcommittee. Johnson has deep ties to the committee, having worked for former Republican Rep. Billy Tauzin when he headed the Energy and Commerce Committee.

When PhRMA hired Tauzin months after the Louisiana congressman helped pass the industry-supported Medicare drug benefit, Johnson followed. So it was not surprising that Johnson did not stay on with PhRMA last year after Tauzin stepped down.

In 2009, Tauzin made more than $4.5 million and Johnson pulled in more than $500,000, according to tax records.

Note that Mr Johnson went from an influential government position to a position representing the pharmaceutical industry, and then back to government
In the same vein and in the same article was:

House Speaker John Boehner hired the medical device industry’s chief lobbyist as his policy director.

Meanwhile, the Minneapolis Star-Tribune noted:

Minnesota health executive Lois Quam has signed to lead the multibillion dollar Global Health Initiative at the U.S. State Department.

A State Department spokesman confirmed Wednesday that Quam will be executive director of the initiative.

In 2009, President Barack Obama committed $63 billion over six years to the program aimed at helping developing nations fight disease, improve nutrition and provide more aid for prenatal and postnatal care.

Quam, of St. Paul, is a former UnitedHealth Group executive who co-founded a health consulting firm last year. She is married to Matt Entenza, a former state lawmaker who ran unsuccessfully for governor in 2010.

The appointment reunites Quam with Secretary of State Hillary Clinton. Quam was a senior adviser to Clinton's health care task force in the 1990s.

Note that Ms Quam went from government leadership (in the Clinton administration's abortive attempt at health care reform via an elaborate version of managed care), to corporate leadership (in one of the largest commercial managed care organizations, some of whose exploits are discussed here), then back to government (now leading global health.  As an aside, UnitedHealth has been developing its global presence for years, e.g., see this post about its forays into the UK.)

We last discussed the "revolving door," that is, the easy interchange among leadership in government and health care corporations here.  The brief news items above shows how the door spins continuously, resulting not only in former government leaders ending up in influential, and well-recompensed positions in the health care industry, but also in industry leaders ending up in influential government positions.  In two cases above, people who started out in influential government positions transitioned to health care corporate positions, and then back to government. 

As we noted earlier, the continually revolving door is a sign of the increasingly corporatist nature of the US.  Government and the biggest corporations now seem to see themselves as natural allies, partially because their leadership increasingly forms a cozy combined group.  The big problem, of course, is such an alliance leaves out everybody else, from small business, to individual professionals, to the people at large. 

As I noted earlier, if we want health care to put the needs of individual patients first, we ought to consider ways to make both government and corporate health care leaders more responsive to the people rather than to their combined self-interest. 

Post Title → Big Door Keeps On Turning - Bi-Directional Interchanges Among Government and Corporate Health Care Leadership

Not Just an American Disease

We have written about attacks on rigorous evidence-based medicine, and particularly on comparative effectiveness research from those with vested interests in having clinical research come out a certain way (e.g., see this most recent relevant post). Those who see such research primarily as a marketing opportunity tend to be offended by the notion of rigorous, unbiased research that may not be so easily turned to marketing purposes. Since I, like the other current Health Care Renewal bloggers, am based in the US, we tend to focus on local examples. But it turns out that the American malady described above has spread to Germany.

From the Science blog, ScienceInsider:

A long-running feud between pharmaceutical companies and the German institute that evaluates the effectiveness of medical treatments could cost the institute director his job. Although the post is supposed to be apolitical, members of Germany’s new coalition government have called for Peter Sawicki, founding director of the Institute for Quality and Efficiency in Health Care (known by its German acronym IQWiG, pronounced ICK-vig), to be replaced with someone who is friendlier to the pharmaceutical industry. The institute’s board of directors are expected to decide on 20 January whether Sawicki, a clinical researcher and diabetes expert, will be replaced when his contract runs out later this year.

Sawicki’s supporters say the move would endanger the institute’s reputation for impartial and rigorous science, and earlier this month a petition signed by 600 doctors and clinical researchers called on the health minister and the board to keep Sawicki on. Gerd Antes, director of the German Cochrane Centre in Freiburg, a not-for-profit organization that analyzes health care effects, says that replacing Sawicki would significantly undermine IQWiG and its work. Antes views the anti-Sawicki push as 'part of the political game to soften and to weaken rigorous procedures for new drugs and medical devices in Germany.'

And it turns out that the American-based pharmaceutical industry has jumped right in.

Big pharma’s attacks have even come from outside Germany. In March 2009, the Pharmaceutical Research and Manufacturers of America petitioned the Obama Administration to put Germany on a trade and intellectual property 'priority watch list' chiefly because of IQWiG’s influence on the German drug market. The petition complained that the institute has 'inadequately taken into account the value of innovative pharmaceuticals,' among other complaints. The Obama Administration declined to put Germany on its watch list.

Parenthetically, "innovation" seems to be a favorite term that those with vested interests in selling products or services use to describe those products, sometimes in the absence of any data that shows them to be superior to the alternatives in terms of important clinical outcomes, that is, outcomes that patients may care about.  "Innovative" was also how complex financial products which contributed to the global economic meltdown were described by those who stood to make money selling, or sometimes simultaneously short-selling them, - but maybe that's guilt by association. 

I hope the Germans are able to preserve their stake in honest, comparisons of tests and treatments that are not influenced by those with vested interests in selling those tests and treatments.

Post Title → Not Just an American Disease

BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody dissected a campaign to redirect comparative effectiveness research by making it responsible to a new governing board that would include "insurance" and "industry" members. And surprise, surprise, the campaign is run by the Partnership to Improve Patient Care, a group that seems to have multiple connections to PhRMA, the pharmaceutical industry trade organization. More stealth health policy advocacy?

Post Title → BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning:

• I had recently written on some (probably) minor issues about CCHIT, the Certification Commission for Healthcare Information Technology. However, I have more substantive concerns. I would like to know how CCHIT functions differently from a fictional "Drug Certification Commission." Imagine such a Commission founded by PhRMA and other pharmaceutical industry advocates, partly staffed at high levels by pharmaceutical executives, and "certifying" drugs for consumer purchase simply on the basis of their being manufactured under cGMP guidelines (current good manufacturing processes). Imagine this Commission declaring drugs "certified" without clinical trials, impartial regulatory oversight, postmarketing surveillance and in the face of equivocal studies and outright unfavorable studies showing increased risk of adverse events. How is CCHIT conceptually and substantively different from this fictional drug certification commission?
  

• I would also like to know how the irrational exuberance over Health IT, vastly accelerated for reasons unclear to me by the "Economic Stimulus Bill", differs from the Madoff scandal. The "Bernard Madoff" version of HIT reality promotes the point of view that even in the face of flimsy and/or contradictory evidence, billions of dollars in investment in today's HIT is guaranteed to reap massive rewards, no matter what. Worse than Madoff's scam, those clinicians who don't invest will be penalized. In effect, the government has now taken over Madoff's Acme Anvil EMR Securities, Inc. and is forcing everyone to invest - or else.
  

-- SS

Post Title → A few not so random thoughts on Healthcare IT

FDA Evaded Bidding Process to Hire Public Relations Firm Which Also Works for PhRMA

Last week, the Washington Post reported the unusual - shall we say - way that the US Food and Drug Administration went about setting up a public relations campaign to respond to some negative criticism it has been getting. Here is the background.

The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products.

FDA leaders decided to hire a contractor for a public relations campaign that would 'create and foster a lasting positive public image of the agency for the American public,' according to agency documents.

How they went about doing this was out of the ordinary.

Tasked with the public relations job was Mildred Cooper, a temporary FDA consultant hired on a two-year contract to advise FDA Commissioner Andrew C. von Eschenbach and other officials. Hired in March, Cooper became an FDA civil servant.

Cooper, who had worked on Capitol Hill and in public affairs for the Federal Emergency Management Agency and Defense Department, called a friend at Qorvis [Communications Inc], which specializes in corporate communications.

Before she joined the FDA, Cooper had worked with Qorvis as a public affairs executive at Luna Innovations, a company that sells medical devices and other products and whose clients include the Defense Department.

'I had experience with Qorvis,' she said in an interview. 'We thought they could help with our communications effort. . . . It was a matter of efficiency.'

She was referred to Don Goldberg, who helps lead Qorvis's crisis communications practice and had once served as part of President Clinton's crisis management team.

Qorvis also represents PhRMA, the drugmakers trade group.

The people involved seemed to have formulated a way to get around the usual government bidding process.

Goldberg discussed the project with [James] Dunn, a business consultant working with Qorvis, e-mails show. They decided to arrange for Qorvis to come into the project through ANI, the Alaska newspaper company, which runs several weeklies and a small public relations office.

Dunn, who works for a firm called Red Team Consulting, told The Post he had experience with the set-aside rules for Alaska Native corporations because he had worked for one as chief operating officer.

ANI, it turns out, is

a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides.

Then,

Other e-mails show that Cooper apparently allowed Qorvis to tailor terms of the contract known as the scope of work.

During most of these discussions, ANI itself was out of the loop.

no one from ANI appeared to be a part of the contract discussions, according to the e-mails. On Feb. 13, Goldberg forwarded a note to Cooper from 'the ANI team contact.' That day, the contact, Washington public relations veteran Aaron Guiterman, wrote to Goldberg, Qorvis and ANI that 'the most likely next step with the FDA is for ANI to submit a proposal.'

In a brief interview, Guiterman said he was not permitted to speak about the contract.

The final result was

On July 23, after more deliberation, the FDA issued a $300,000 purchase order for the public awareness campaign, with ANI listed as the contractor. An FDA official said ANI had pledged in writing to do more than half the work.

Two parts of this are remarkable, of course. One is how a government contract to a big Washington PR firm was arranged without any public bidding or scrutiny. The second was that the company chosen for this contract to improve the image of the FDA, the agency responsible for regulating pharmaceutical companies, went to a firm which also worked for PhRMA, the pharmaceutical industry trade organization. Could this excess coziness of some FDA officials with the pharmaceutical industry, which the agency is supposed to regulate, be evidence of "regulatory capture?" On a policy level, it seems that the US needs to have a much clearer separation between the FDA and the targets of its regulation.

Hat tip to the WSJ Health Blog.

Post Title → FDA Evaded Bidding Process to Hire Public Relations Firm Which Also Works for PhRMA

The Karasik Conspiracy: "the Novel the Pharmaceuticals Industry Tried to Commission, Then Control, and Finally Kill"

We have previously posted (also here and here) on the abortive efforts of the Pharmaceutical Research Manufacturers of America (PhRMA) to covertly sponsor the writing of a thriller about terrorists poisoning drugs imported from Canada to inflame the public about the dangers of importing drugs from overseas. At some point, elements of the PhRMA leadership realized their folly, and sought to cancel the project. But the spurned authors refused to accepted an additional payment to close out the project, but never to talk about it. Instead, they rewrote their tome, making a pharmaceutical company one of the villains.

The new version, now entitled "The Karasik Conspiracy," has been published, and, of course, has its own web-site. It announces, "the novel the pharmaceuticals industry tried to commission, then control, and finally kill."

The site is remarkable because it includes transcripts of many emails among the authors, the consultant for PhRMA who arranged the project, and PhRMA executives. Some choice bits:

• On the purpose of the book - "This memo will confirms [sic] our conversation that I would like to commission the authoring and publication of a gripping fiction novel aimed at realistically depicting the potential terrorist threat to the pharmaceutical supply of our nation." "Confidentiality with respect to the origins of this project is paramount." [Mark Barondess, consultant to PhRMA, to Michael Viner, owner of Pheonix Books, the publisher] (See link here.)
• Barondess' second thoughts seemed to be more related to his literary criticisms than concerns about the ethics of the project - "I want you to know that I finished reading the book and while improved, it is still a very difficult read. It does not matter to me that books in the spy genre are usually hard to read—all I care about is whether someone will pick up this book and either never buy it or worse yet, stop reading it. I thought that we requested that the fundamental premise of the book was to change. While the Muslim component was added in the beginning, it completely fizzles out in the rest of the book. I still do not accept the premise that Spivak is going to attempt to blackmail the US over Serbia—it is just silly. It would be better if he was just a sociopath that wants to harm Americans because we are infidels." [Barondess to Viner, July 7, 2005] (Link for this quote and all others below is here.)
  "We do not want anyone to get hurt and we will not let that happen to you or the company. The bottom line is that we still do not have a book that is satisfactory to us. Maybe with the steps we discussed today, we can get there."[Barondess to Viner, July 9, 2005]
• On the involvement of Valerie Volpe, Director of Professional and Patient Relations for PhRMA - " I have just finished my review of the manuscript. While the book is significantly improved, in my view, it still requires more editing. Valerie is reading it tonight and has promised to give me her comments by the close of business tomorrow. A couple of things will help make a decision of whether to continue forward with the book. Is there an objection if we take over the editing? It seems that it would simplify the process." [Barondess to Viner, July 11, 2005]
  "I provided the writer with literally volumes of data to guide the storyline. I spent considerable time in person with the writer clearly outlining the premise of the book and the goals we expected to achieve." [Volpe to Barondess, July 19, 2005]
• PhRMAs attempted cancellation of the book was again based on concerns with the book's literary quality, not the ethics of the project - "The book that was sent was unsuitable in every respect, especially given the fact that the book was written by an author with no experience whatsoever in this genre. That lack of experience was apparent not only in the first draft (and pointed out to you), but in all subsequent drafts." [Barondess to Viner, Aug 2, 2005]
• PhRMA attempted to keep the whole thing quiet, and not to have any new book derived from the project say anything derogatory about the pharmaceutical industry - "I will pay you $100K in consideration of a full and complete release of claims from all parties, agents and employees. I need a confidentiality agreement regarding the work you were performing and confidentiality of the settlement agreement. I also need an agreement that there will be nothing written in the book which is adverse to the pharmaceutical industry, and that I will have the right to approve any manuscript, consent not to be unreasonably withheld." [Barondess to Viner, Aug 2, 2005]

You just can't make this stuff up.
Assuming that this web-site is closer to the truth than the novel is, this is a vivid illustration of how leaders of big health care organizations have substituted propaganda, disinformation, and intimidation for reasoned debate and discussion about health care issues.

Post Title → The Karasik Conspiracy: "the Novel the Pharmaceuticals Industry Tried to Commission, Then Control, and Finally Kill"

Pulp Phiction

The story of how the Pharmaceutical Research Manufacturers of America (PhRMA) paid for the writing of a thriller about terrorists poisoning drugs imported from Canada seems to have legs.
We previously posted about it here and here.
Now the story has been recounted in Slate, in an article by Shannon Brownlee and Jeanne Lenzer. This version clearly summarizes the story so far, and then adds a few bits that weren't in our earlier posts. One bit was about Mark Barondess, consultant to PhRMA. When he tried to cancel the project, he offered $100,000 to the authors of the book manuscript, but on the condition that they would sign a formal nondisparagement agreement, promising not to disparage "Barondess, the pharmaceutical industry, or PhRMA" in any "public, private, or promotional statements or writing." Another bit is that the current version of the book features a pharmaceutical company as a villain: the plot reportedly has the company poisoning Canadian drugs, then trying to blame it on terrorists.
In one sense, this story is so ridiculous that it's hard not to laugh out loud - LOL as my teen-ager would text message - at it.
But in another sense, it's deadly serious. Medicine is a serious undertaking. Physicians prescribe drugs in an effort to help prevent or alleviate pain and suffering, or prevent or cure disease. Patients and physicians depend on having accurate, unbiased, complete evidence about these drugs to help decide which drugs should be taken, when and how much, based on clear information about the drugs' benefits and harms.
Stories like this bring into question all the information we get from the pharmaceutical industry. Although I'm sure that much of what the industry says and does is honest, it's no longer clear how to separate the good stuff from the ridiculous stuff.
The many honest, hard-working, smart and capable people in pharma need to stand up and put an end to this nonsense, before the nonsense puts an end to what used to be some great and highly-respected companies that made products that did a lot of good things for patients.

Post Title → Pulp Phiction

An Update: PhRMA Commissions a Thriller

We previously posted about how the Pharmaceutical Research Manufacturers of America (PhRMA) paid for the writing of a thriller about terrorists poisoning drugs imported from Canada. This story was picked up by two major newspapers, the Los Angeles Times and the Philadelphia Inquirer. New, increasingly bizarre details have emerged:

• The publisher of the thriller, Phoenix Books, is owned by Michael Viner. Viner previous owned Dove Entertainment, which published books on the O. J. Simpson murder trial and the "society madam," Heidi Fleiss. Two of three authors of Dove's book on Fleiss sued Viner for sexual harassment, and the other won an award after she claimed Dove failed to pay her royalties.
• Viner next founded Millenium Entertainment, which published "Burning Down My Master's House by disgraced former New York Times reporter Jayson Blair.
• The writing of the book was supervised by a PhRMA marketing executive, who required that the book's villains be militant Muslims, but motivated by greed, not politics; that the book contain "frilly feminine stuff"; and that it incorporate long passages from congressional hearings.
• Jayson Blair briefly served as editor for Phoenix on the project, but departed the project and the company after a "contentious phone conversation" with author Julie Chrystyn, and allegedly "trying to abuse his expense account."
• PhRMA canceled the book project after paying authors Chrystyn and Kenin Spivack $100,000, but promised them another $100,000 "if they would agree never to speak ill of PhRMA or the drug industry for the rest of their lives. They refused."
• PhRMA Senior Vice President for Communications Ken Johnson called the scheme "idiotic," and insisted that the PhRMA official who sanctioned the book contract was "a lower level employee who acted without authority," for whom the organization is "presently reviewing disciplinary options."
• The employee was actually Valerie Volpe, according to the Philadelphia Inquirer, a "deputy vice president for federal and state affairs," (but documents on the web identify her as "Director of Patient and Professional Relations.)
• The book, entitled the Karasik Conspiracy, is due to be published in December. "The villains of the plot have undergone yet another transformation. They're now a rainbow coalition of Bosnians, Eastern Europeans and Americans, including a stereotypical representative of an American corporation: to wit, a pharmaceutical company."

According to Philadelphia Inquirer reporter Thomas Ginsberg, "This is no pulp fiction farce. Call it bookgate, an impossible-to-make-up public-relations disaster now dogging the pharmaceutical industry." Call it a another, particularly lurid example of how large health care organizations resort to deception and dishonesty to promote their causes.
What argument do they have that physicians and patients should trust them?

Post Title → An Update: PhRMA Commissions a Thriller

A New Kind of Ghost-Writing: PhRMA Commissions a Thriller

In the New York Daily News, a truly bizarre story.

It seems that the Pharmaceutical Research and Manufacturers of America (PhRMA), concerned about the increasing popularity of importing drugs to the US from Canada, came up with a scheme to reduce the credibility of this tactic. The Daily News reported that an outside consultant suggested that PhRMA commission a paper-back thriller to dramatize the dangers of imported drugs. The book was to be published by Phoenix Books, and written by ghost-writer Julie Chrystyn.

The plot concerned a Croatian terrorist cell

that uses Canadian web sites to murder millions of unwitting Americans looking for cut-rate pharmaceuticals.

The book was titled, "The Spivack Conspiracy," after Chrystyn's friend Kenin Spivack, who then became a co-writer.

PhRMA suggested several changes in the draft of the first 50 pages, according to Spivack, including

They wanted it somewhat dumbed down for women
They also wanted to change the motivating factor of the terrorists to greed, because they didn't want it to be politics. They wanted lots of people to die.

Eventually, PhRMA pulled out of the scheme. Its executive vice president Ken Johnson acknowledged the plan, but blamed the idea on "an outside consultant," and concluded, "in the final analysis, [we] decided it wasn't the right thing for us to do."

The News reported, however, that PhRMA did make at least one payment to Pheonix Books.

Again, do they expect to build trust in this manner?

We earlier posted about an editorial which called for the recognition of the brutal facts of health care. One such brutal fact is that leaders of large health care organizations do not shrink from using deception to serve their interests. Until we ensure the transparent governance of such organizations, the brutality will continue.

Thanks to PharmaGossip for the tip.

Post Title → A New Kind of Ghost-Writing: PhRMA Commissions a Thriller