Policy and Medicine

Pfizer Publishes Grants

Pfizer published a list of grants that were given in first quarter 08, this included all charitable and educational grants. 

They had announced in March in a letter to Senator Grassley that this was a work in process.  This is a growing trend in our industry started by Eli Lilly and is being considered by most of the major pharmaceutical companies. 

“We want to bring greater transparency to the way we partner with leading medical, scientific and patient organizations,” said Jeffrey B. Kindler, Chairman and Chief Executive Officer of Pfizer. “Detailing these grants and charitable contributions is an important part of our ongoing transparency drive.”

From first reading of the grants and recipients, these disclosures show just how committed companies are to helping society and include grants for Aids projects in Africa, Malaria Patient Education and Treatment, and a large initiative (approximately 1/3^rd of Grant funds) by the California Academy of Family Physicians and others on reducing smoking to improve public health.

If we disclose, perhaps the outside world will better understand the value of what is being done to educate healthcare providers and others and the value to the medical and patient community.  Click the link for a full listing of recipients and accompanying press release .

We Moved MA 2650 -- Now Massachusetts 2660

Please use the following link to follow Massaschusetts 2650, the new bill number is Massaschusetts 2660 we have moved all the content on to the new area, and we also got the spelling right this time.

Massachusetts S2660

Physician Payment "Sunshine -Version 3.0"

Senator ‘s Charles Grassley and Herb Kohl yesterday released a press release that included summary of the latest version of the Physician Payment Sunshine Act. Senators praise growing support for transparency in drug industry payments to physicians

At the same time they announced the support of Pharmaceutical Manufacture, Eli Lilly came out yesterday in support of the revised bill, along with several other endorsements including the AAMC.

The Bill:

Reporting: beginning 3/31/2011 any payment or transfer of value or ownership

Penalties:  $1,000 to $5,000 per failure to report, with an annual cap of $50,000, and

$5,000 to $50,000 per knowing failure to report, with an annual cap of $250,000.

Website – posted on a website through HHS

Preemption – preempts state reporting requirements

Delayed reporting -- for two year or until FDA Approval

Definitions—includes all drug, device and medical supply companies.

Covered recipient: a physician, medical practice or entity that receives payment on the request of or designated on behalf of a physician.

Expenses does not include anything under $25.00 in value, product samples, certain education materials and direct training, and equipment loans

In their press release the senators praised Eli Lilly for their letter of endorsement:

“Eli Lilly deserves credit for its endorsement of the Sunshine Act and the leadership role

it is taking for greater transparency in the pharmaceutical industry. Eli Lilly has been posting

online its payments to medical organizations and others. The company’s forward-looking

endorsement of legislation to require reporting of financial relationships between drug and

device makers and physicians will be valuable in building more support for this important

reform,”

“Lilly…believes this legislation represents an important step in building public trust and confidence in the relationships between the pharmaceutical and device industries and physicians,”

John Lechleiter, Lilly’s new CEO, in a statement about this bill stated. “This will help provide the assurance that Lilly runs its business consistent not only with our principles, but with the principles that a healthcare provider or patient should expect from a pharmaceutical company.”

Another recent endorsement came from Association of American Medical Colleges letter of endorsement  Grassley said. “I also appreciate the persuasive and principled support of the

Association of American Medical Colleges. Transparency brings about accountability and

benefits everyone, consumers most of all.”

Also as part of this they released a Side-by-side comparison of proposed legislation with existing state law

This bill is significantly more reasonable than the house version, already one group of radical state legislators, NLARX have come out against the proposed revision.  NLARX PPSA release 51308

We are still evaluating the language of the bill and will post additional thoughts in the coming days.

JAMA Ghosts = Invisible News

A couple of weeks ago, we covered the release of the JAMA Ghost writing article JAMA articles on Ghost writing and Study Results draws attention, later we discussed that one of the authors had been caught with his finger in the cookie jar. JAMA: Ghost Author's Skeletons.

Today Nature’s editorial board -- Nothing to See Here -- writes that there was nothing new about ghost writing, that this is not unlike in other team efforts “in which everyone in the team has different jobs. Some people do clinical research, others write papers. Not necessarily a big deal, or a big surprise.”

The second problem with the article is that JAMA did not apprise Merck of the release of the article, or opportunity to respond.  “That left the company with only the press to air their side of the story, certainly not any way to get to the bottom of the issue or promote a healthy exchange of views”.

According to Nature, it does not reflect the current practices at Merck, as the paper was based on five year and older data. “Indeed, no one at JAMA bothered to find out that Merck adopted as its policy for authorship the International Committee of Medical Journal Editors’ guidelines (http://www.icmje.org/)”

“But the JAMA editorial then goes too far, leaping on the findings to make recommendations that are unwarranted, not to say discriminatory, against the body corporate.”

In recommendation 5, the JAMA editors call for sponsored research not to be solely in the hands of the sponsoring company. Rather, they propose that academic researchers who are not employed by the company should bear primary responsibility for collecting, analyzing and reporting data. So, who would these academics be, and what constitutes ‘being in the employ’? How would this work for companies that don’t partner with academics? Would accepting research support disqualify academics? Would receiving honoraria disqualify them?

According to Nature, "The editors of JAMA and other journals would do well to focus on content, not process. JAMA’s attack casts a cloud over the entire industry."

JAMA Editor Catherine D. DeAngelis, MD is known to be a long time critic of pharmaceutical, biotech and device industries and private companies' involvement in conducting research and CME, and she regularly goes out of her way to attach her agenda to almost any issue.   The ghost writing articles are just one more example in a long line of editorials critical of everyone who does not espouse her agenda.  (For more on Catherine’s philosophy in her own words: The Influence of Money on Medical Science)

JAMA’s editorial staff is using flimsy evidence to support an agenda, an agenda where they suggest academics control all aspects of clinical trials with no financial interest.  But the problem is that without financial interest there is no incentive to fund the research in the first place.   

http://www.nature.com/nbt/journal/v26/n5/abs/nbt0508-476.html

This philosophy is several millenniums old, and it didn’t work in Athens, Rome or Moscow, it is not going to work today.

Disclosure = Wanted for Intimidation

So what do these groups advocating "doctor disclosure" really want from government mandated public disclosure laws? 

The answer to that question was published recently on NLARX’s (National Legislative Association on Prescription Drug Prices) website, in a slide presentation entitled: State Laws Requiring Disclosure of Gifts and Payments to Health Providers- What’s Effective and Why? by Peter Laurie of the Health Research Group at Public Citizen (one of Ralph Nader’s groups). 

And, guess what we discovered?  Disclosure laws are being promoted to facilitate investigative reporting by journalists.

The laws Laurie highlights require reporting "gifts" to doctors as low as $25 (Maine and Vermont) or $100 (Minnesota and West Virginia).  In many instances, a "gift" is defined as anything of value and this can include any work done by a physican in collaboration with a company!

In brief, it appears Laurie and his friends believe doctors should face at least as much scrutiny (and perhaps more) than a member of the US Senate.  For instance, Senators are required to report gifts aggregating more than $335, but gifts less than $134 aren’t counted!

In his presentation, Laurie defended the idea, answering the question: “Why a Doctor Gift Registry?”

(click to enlarge)

First he says, it would:

• Provide accountability and transparency to patients. ("Doctor I am dying of a heart attack, but wait let me look to see if you consulted with any companies"  This is not likely to happen and I am not sure if a patient knew Doctor X consulted for a company most patients would see that as a bad thing as they would like to be seen by an expert.)
• Restore trust in medical profession (exactly how does publishing a list of what doctors earn add to restored trust?)
• Transparency/accountability to providers (this is to promote professional jealously, "I saw you made X.")
• Transparency/accountability to payers (is this really in the best interest of the physician to be questioned on yet another point by CMS, the state, or their local PPO or HMO?)
• Promotes research (esp. if names provided).  (just what research does Laurie have in mind?  The one type of research he mentions is another point -- that the laws would: "Facilitate investigations by journalists." 

Who else could use this data for research? CMS, insurance companies, even trial lawyers come to mind….!

The proposed legislation on the NLARX website, advanced in conjunction with “The Prescription Project,” would require a national, published, and continually updated list of any doctor who has received a gift as well as the type of gift.  This information would be a matter of public record.

We don’t know what Laurie actually said verbally when he presented the slides, but the only point he expanded on is about journalists. Here is his next slide:

(click to enlarge)

He outlined journalistic investigations with these points:

·    Comparisons by specialty

·       Links to “thought leaders”

·       Links to state disciplinary actions

This all sounds so innocent, except when you put it in context that this data will be used to dissuade physician inventors and researchers from collaboration with industry.   I guess that means to save a few bucks we have resorted to articles in newspapers about "greedy" doctors, who are actually decent doctors devoted to bringing on board the next generation of lifesaving treatments.   

Or consider that trial attorneys will use this data to include in their lawsuits all physicians involved in the creation and marketing of drugs in question.  Who will want the hassle of developing and bringing to market new therapies, if people will try to ruin their lives for their effort?

In the end we will look back and wonder what trust will be restored from these initiatives?

What the Doctor Ordered

A great article for your weekend read

Sally Satel, MD – What the Doctor Ordered…..

Dr. Satel outlines the need for "freedom of interaction" between industry and academia....  Enjoy...

Another great story that caught my eye this morning was a story about Ruth Day (from the DTC hearing) and her performance, apparently she made the same presenation in 2005 at an FDA hearing -- the Nasonex Bee -- very funny:

Ruth  Day  and  the  Bees  Repeat  Performance  at  House  DTC  Hearing

DTC Hearing on the House

The House Committee on Energy and Commerce, Subcommittee on Oversight and investigations today held a public hearing :  Direct-to-Consumer Advertising: Marketing, Education, or Deception  (don’t you love these hearing titles, I wonder what the outcome will be)

The hearing included witnesses from behavioral science, managed care, AMA and industry.  (At the bottom of this posting are links to all statements and the webcast of the hearing)

Some of the opening remarks by Subcommittee Chairman Congressman Bart Stupak included:

Nearly 10 years ago, the U.S. Food and Drug Administration (FDA) relaxed its rules related to direct-to-consumer (DTC) advertisements for prescription pharmaceutical products.

Since then, spending on DTC ads has increased from about $1.1 billion in 1997 to about $4.2 billion in 2005.

This nearly 300 percent increase in DTC ad spending dwarfs the 86 percent spending increase in advertisements to physicians and the 103 percent spending increase in research and development over the same period.

The purpose of the hearing is to examine the potentially misleading and deceptive tactics used in direct-to-consumer (DTC) advertisements (ads) for prescription pharmaceutical products.

Our hearing .. will examine three specific television advertisements: ads for Lipitor featuring Mr. Robert Jarvik, ‘Food and Family’ ads for Vytorin and ‘cancer fatigue’ or ‘quality of life’ ads for Procrit.

Pfizer’s Lipitor ads featured

Mr. Robert Jarvik, an individual

Never Licensed to practice medicine

Paid $1.35 million dollars for the ads (not disclosed)

Only started taking Lipitor two months prior to ads appearing

“These ads are in violation of the American Medical Association’s guidelines concerning the involvement of health professionals in DTC advertisements”

Merck and Schering-Plough’s ads for Vytorin

$5 billion dollars in sales in 2007.
Concerned about Enhance Data (two year delay)

To him a generic Zocor would have been better

Taxpayers spent needless millions on Vytorin via Medicare part D

Johnson & Johnson’s Procrit was approved by FDA to treat chemotherapy - and dialysis-induced anemia.

Marketed directly to consumers for the treatment of ‘cancer fatigue’ in order to improve the ‘quality of life’ for patients. (It should be noted that the Procrit ads were pulled in 1995)

This was clearly an instance of off-label marketing - a practice that is prohibited by FDA.

Not only did the company advertise the drug, but FDA did nothing to stop them.

These are three examples of drug companies acting improperly.

Our goal today is to expose the deceptive and misleading aspects of each of these television ad campaigns, but also those of DTC ads in general.

We also intend to explore better practices for DTC marketing.

It is likely that DTC ads will continue, and pharmaceutical companies may continue using the same questionable practices that were used in these three ad campaigns.

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for regulating DTC ads.

Drug companies are required to submit copies of their ads at the same time that they are disseminated, but no preclearance is yet required.

If a DTC ad is found to be in violation of FDA regulations, FDA can issue written letters for serious violations, which may lead to regulatory action by FDA.

However, if a company refuses to comply, FDA cannot impose fines except through an administrative hearing.

“I believe that Congress needs to decide whether the U.S. should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required. “

If the three ads that we will discuss today are indicative of typical DTC ad campaigns, it appears that we need to enforce significant restrictions on DTC ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies.

The opening remarks of the incoming AMA president (Nancy Neilson, MD, PhD included:

Direct to Consumer Advertising (DTCA) has become ubiquitous and neither regulatory oversight nor research on its impact have kept pace.  As a result, the American Medical Association (AMA) has serious concerns that DTCA is neither balanced nor educational, may adversely affect physician-patient relationships, and contributes to rising healthcare costs.

She went on to outline what steps the AMA recommends in changes to the DTC process including companies adopting the AMA guidelines for DTCA  (see bellow for her full statement)

Molly Ann Brodie, PhD from Kaiser Foundation outlined that the public and physicians have mixed feelings about DTC and she felt that more oversight to ensure accuracy of the advertising was in order.

This is a complicated issue, as thirty second to two minute commercial breaks, don’t allow for any in-depth information given, only to point the way to a physician.  There will be more on this to come…..

For a full listing of documents on the hearing and watch the webcast:

Direct-to-Consumer Advertising: Marketing, Education, or Deception 

Subcommittee Chairman’s Bart Stupak’s full remarks

Just press on the speakers names for their remarks

Ruth S. Day, Ph.D.

Director, Medical Cognition Laboratory

Duke University

Nancy H. Nielsen, M.D.,Ph.D.

President-Elect

American Medical Association

Marcia G. Crosse, Ph.D.

Director, Health Care

U.S. Government Accountability Office

Mollyann Brodie, Ph.D.

Vice President

Director Public Opinion and Media Research

Kaiser Family Foundation

James Sage

Senior Director/Team Leader, Lipitor

Pfizer Inc.

Kim J. Taylor

President

Ortho Biotech, Inc.

Deepak Khanna

Senior Vice President and General Manager

Merck/Schering-Plough Pharmaceuticals

GSK Exec Expresses Concern to Massachusetts Leadership

This week, Christopher A. Viehbacher, president U.S. Pharmaceuticals GlaxoSmithKline, sent a letter to the leadership in Massachusetts  suggesting his firm might not invest as much in Massachusetts if “political developments” work to “devalue” its assets here. 

"Some Massachusettes political leaders, meanwhile, seam to go out of their way to attach and demonize an industry that those in other parts of the country are desperate to have." 

According to the Boston Herald, Glaxo Exec Blasts State the Governor and House leadership were stunned.

It’s important that the leadership of the State of Massachusetts understand the consequences of apdotion of Section 26 of S2660 to the pharmaceutical and medical device industries.  And especially the bill's negative impact on education and research in the Commonwealth of Massachusetts.

SACME Responds to IOM

Society for Academic Continuing Medical Education (SACME) last week released their response to the Institute of Medicine Committee on Conflicts of Interest in Medical Research, Education and Practice. It is clear from what they submitted that SACME members rejected many of the controversial recommendations made by the Macy Conference Summary; and held to a general consensus that commercial support for CME is beneficial for the intuitions and their physician learners.

The report gave several challenges to changes in the present CME system. Their points represent major hurdles to changing our system:

Funding: “Many academic institutions provide little or no funding to CME, but rely on units to fund themselves or raise funds for the institution. Loss of current funding from commercial interests may result in fewer educational activities with increased cost to the institution.”

Institutional role “…continuing education is often not a focus of the educational system.  Expectations point more to CME’s marketing role in representing the institution…”

Cultural change “In addition to the issue of CME as a support for hospital activities, most physicians have been trained in an environment in which lectures and conferences are provided at no cost. Asking physicians to bear more of the cost of their professional development comes with the challenge of developing activities that are more effective. Though changing, many learning opportunities demand little of participants. Many physicians lack practice in learning using different modalities, and experience a level of discomfort.”

“…Lectures are a cost effective way to present information, requiring relatively little of planners and participants. Using approaches that have been shown to be more effective, and linking CME to quality initiatives, requires expertise on the part of planners as well as faculty. CME professionals with skills in instructional design, evaluation, and teaching/learning to support faculty are essential, but require more time and money.

In preparation for their response they conducted a survey of their members. Perhaps of most interest, just less than a quarter, (24.4 %) of the academic CME providers supported eliminating support for CME by commercial enterprises.

Here’s the question and responses Funding from commercial interests must be eliminated from academic CME .

Response Percent Count (actual number of respondents)

Strongly disagree 24.4% 22

Disagree 36.7% 33

Neutral 14.4% 13

Agree 12.2% 11

Strongly agree 12.2% 11

On a somewhat related issue, the group opposed by an even wider margin eliminating faculty members with commercial connections.

Only 19.8% of academic educators agreed with the idea of eliminating those with commercial connections.

Faculty must not teach in academic CME if they have relationships with commercial interests.

Response Percent Count (actual number of respondents)

Strong disagree 14.3% 13

Disagree 47.3% 43

Neutral 18.7% 17

Agree 13.2% 12

Strongly agree 6.6% 6

At the same time, a majority of the group (60%) opposed offering free lunches and gifts associated with CME activities. One can only wonder if this will actually serve the purpose of increasing the quality and participation in CME .

All gifts, including free lunches, must be eliminated from activities with CME credit.

Response Percent Count *actual number of respondents)

Strong disagree 5.6% 5

Disagree 21.1% 19

Neutral 13.3% 12

Agree 32.2% 29

Strongly agree 27.8% 25

SACME is the professional organization for educators and physicians in medical schools, academic health science centers, professional/specialty organizations, and other interested academically based professionals. SACME’s mission is to promote research, scholarship, evaluation and development in continuing medical education ( CME ) to enhance the performance of physicians and other healthcare professionals.

For a complete copy of the report: http://www.sacme.org/site/sacme/assets/pdf/SACME_Report_IOM_COI_April_17_2008.pdf

JAMA: Ghost Author's Skeletons

We recently reported about a paper published in JAMA titled Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. One of the co-authors, we discovered through some simple research is someone who’s made a good living as an expert witness suing drug companies. In fact, he’s been so devoted to that cause that according to a New York Judge he arranged to steal documents under sealed court order and leak them to the New York Times Doctor Who Leaked Documents (September 8, 2007). He ended up being soundly chastised by a federal judge, and he was required by that judge to pay the company he stole the documents from, Eli Lilly & Co., $100,000, the judge called these actions "reprehensible".

This co-author was Dr. David Egilman, a professor at Brown University in community health, (as noted on his website, he has no research or clinical trial experience to earn a place publishing in JAMA). He has according to one Texas newspaper, earned millions testifying as an expert witness in about 100 personal injury trials; he’s been deposed hundreds of times – generally for the plaintiffs.

In fact, he may have a particular interest in derailing a Merck Vioxx settlement, which the publication of the critical report in JAMA at this time might contribute to. He is a serial plaintiff witness in the Merck Vioxx trials and JAMA should have seen these as serious conflict of interest, an even greater conflict of interest than any of the alleged ghost writers he criticized.

It’s possible the personal stakes for the authors of the JAMA piece are enormous. After all, the longer the case goes on, the bigger the fees for the attorneys involved – and their expert witnesses!

Of course, we don’t know the real amount of Dr. Egilman’s earnings – that’s confidential!

In the JAMA editorial accompanying the paper, Katherine DeAngelis’s, MD Editor of JAMA stated “"To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs."

Perhaps this would be a more appropriate editorial “To maintain a healthy distance from being duped by trial lawyers JAMA should not condone or tolerate for-profit plaintiff witnesses having any input into the content or trial attorneys providing funding or sponsorship for “peer reviewed” papers, which condemn those they are suing, especially if the author has leaked confidential information to the press been chastised by judges and forced to pay six figure fines.

I challenge the board of JAMA to investigate the “Peer Review” process for this series of articles and at the very least chastise their editor for poor author checking (a simple Google search of David Egilman and Merck and this only scratches the surface)

For more about Doctor Egilman and his exploits “Without Fear or Favor” or simply type his name on Google, it is amazing what you will find…