Policy and Medicine

Physician Payment Sunshine: Cephalon Agreement to Act

Every industry has its bad actors.  In the case of pharmaceutical companies the bad actors fall into two categories; those who in the past have given kickbacks to physicians and those who actively promote off label uses for their products.

In the case of Cephalon they were using their sales force and marketing practices to promote off label uses for three of their drugs:

Provigil, Gabitril and Actiq

Cephalon even dedicated part of their sales forces to physicians that would have no reason to prescribe their drugs for approved purposes.  The promotion showed: over 80% of the scripts written were for off label uses.

Cephalon has agreed to a $425 million Qui Tam settlement and guilty to one misdemeanor charge. Cephalon Corporate Integrity Agreement  "Qui tam" is Latin for "who is as the king," and the False Claims Act allows people to sue on behalf of the government if they have evidence of wrongdoing. 

What makes this case unique is that it's the first time, in the absence of substantial kickbacks, that the federal government has used the False Claims Act to go after a pharmaceutical company for marketing drugs for off-label indications for which there were no credible published scientific research supporting these drugs' safety or effectiveness," said Peter W. Chatfield, a Washington, DC, attorney with Phillips & Cohen LLP.

It is an interesting case in that a sales person for Cephalon complained to the FDA and wore a wire to a sales meeting in the investigation.

The Corporate Integrity Agreement includes policies around reporting payments to physicians and disclosing grants including educational and charitable grants.

Some key points in the settlement:

            Cephalon agreed to a written code of conduct that included:

A)   Compliance with all federal and FDA requirements

B)   All personnel, suppliers and consultants will shall be expected to comply with all federal and FDA requirements

C)   Reporting of suspected violations to the Cephalon Chief Compliance Officer

D)   Consequences for failure to comply and report

E)   Disclosure program

Policies and Procedures:

A)   Adherence to the “Code of Conduct”

B)   Appropriate conduct of promotional and product services functions to meet all federal program requirements including “kickback laws”

C)   Appropriate conduct of promotional and product services towards FDA requirements

D)   Mechanism for handling off label requests for information including a database of questions and answer and requesters.

E)   Development of sales call plans for provider types consistent with FDA approvals.

F)   Consultants and other fee-for-service arrangements including (advisory boards, speaker programs, advisory boards) with Healthcare Providers are used for legitimate and lawful purposes, in accordance with FDA and federal healthcare programs.

G)   Employee and Field Force Education of Policies and Procedures

H)   Sponsorship or Funding of grants (including educational grants and charitable contributions) designed to ensure that Cephalon funding satisfies all applicable federal healthcare and FDA requirements. 

I)     In Regard to Grants:

a.    Cephalon will disclose its financial support of Third Party Educational Activity and any financial relationships with faculty, speakers, or organizers at such activity;

b.    as a condition of funding, the third party shall agree to disclose Cephalon' s financial support of the Third Party Educational Activity and any financial relationships that Cephalon might have with faculty, speakers, or organizers at such Activity;

c.    any faculty, speakers, or organizers at the Third Party Educational Activity disclose any financial relationship with Cephalon;

d.     the Third Patyr Educational Activity have an educational focus;

e.     the content, organization, and operation of the Third Party Educational Activity be independent of Cephalon on control;

f.     Cephalon support only Third Party Educational Activity that is non-promotional in tone/nature; and

g.    Cephalon's support of a Third Party Educational Activity shall be contingent on the provider's commitment to provide information at the Educational Activity that is fair, balanced, accurate and not misleading;

J)    Review of promotional materials by (regulatory, medical and/or legal personnel) to ensure adherence to regulations

K)   Funding of Medical Research complies with FDA and federal requirements

L)    Compensation for relevant covered persons to ensure that these financial incentives do not inappropriately motivate to engage in proper sales and marketing

M)  Disciplinary Policies for Violation of Policies and Procedures

Reporting of Physician Payments

By January 31, 2010 Cephalon will post on their website in a searchable website the value of payments to physicians who received any (directly or indirectly) in 2009. For the year 2010, they will have to post quarterly.  Reporting will be in $10,000 increments ($0-$10,000, $10,000- $20,000…)

This is the first case of a pharmaceutical company being required to report payments to physicians by their corporate integrity agreement.

This case shows that the system of checks and balances is working.  This settlement sets an example that companies who violate the law will pay huge penalties ($425 million is huge; roughly equal to $100 million more than the Cephalon’s entire net income for 2007) and cannot afford to make those same mistakes again. Others who are watching will be quick to make changes to their policies and procedures to avoid such penalties.

Key Resources

Wall Street Journal: Cephalon Agrees to Greater Oversight

AP: Cephalon to pay $425M for improper drug marketing

Cephalon Corporate Integrity Agreement

Philips and Cohen Press Release

Kenney Egan McCafferty & Young, P.C. Press Release

Kenney Cephalon 2003 Complaint

Cephalon Corporate Q&A

WSJ: Narcotic 'Lollipop' Becomes Big Seller Despite FDA Curbs

Pfizer Cardiovascular: The End of an Era

Pfizer announced WSJ: Pfizer Plans to Abandon Heart-Drug Development  that they are giving up on the Cardiovascular business and no longer developing compounds in cardiovascular disease, instead focusing on oncology and other areas. 

 This is quite a statement coming from Pfizer, given the long history in cardiovascular disease with block busters in the last ten years such as Norvasc, Caudura, Viagra, Acupril and Lipitor.   Pfizer was a CV power house,  and they bought Warner Lambert just so they could get even bigger in CV, and now they leave the field. (amazing)

Admittedly Pfizer has a huge problem with their labs, there have been no CV drugs developed since Viagra, but Pfizer has been very good at licensing CV compounds and selling them like no one else could.

This must be a shock to BMS their partner on oral anti-clotting therapy—apixaban, that they would be abandoning the space, but perhaps this is not the end, and they are just giving up on development, which is not their strong suite. 

This probably explains some of their high minded proclamations (i.e. we don’t have any money to spend so let’s blame it on everyone else).

Even though they are leaving their presence will be missed.

Letters from Grassley: NIH Check this Out

This week Senator Grassley sent some more letters, Grassley asks NIH to account for employment of expert advisor, this time he is concerned that National Institutes of Health may be trying to get around its own policies to prevent conflicts of interest by hiring medical experts with ties to industry as contractors rather than full-time employees.

Grassley based his questions for the Director of the NIH, Elias Zernouni, MD on the case of a senior advisor for the National Heart, Lung and Blood Institute within NIH.   

Marvin Kostam, MD who is Chief of  Cardiology s of Tufts University School of Medicine and Tufts-New England Medical Center, while also acting as a high profile advisor and advocate for a cardiac device company and serving as a consultant to NIH.

Dr Kostam is a legend in the heart failure community and the company he is listed as medical director for Orquis Medical is in early stage development of devices for heart failure. (Not exactly a commercial enterprise yet).

At one point the senator raises questions about a press release that was sent out last week discussing first in man trials on one of their devices.  The confusion for the senators staff comes in that he is listed in the press release as Chief of Cardiology at Tuffs.  Another point of contention for the Senator was a month after his appointment at NHLBI,  Dr. Kostam was listed as Chief of Cardiology at Tuffs in a journal article in circulation one month after he started at NIH.  He also listed his Tuff’s affiliation for an FDA panel.

Partially this all can be explained in that Dr. Kostam is on a one year leave of absence from his position at Tuffs to serve as a consultant to NIH, which is only recently investing in heart-failure research.   This entitles him to keep his title at Tuffs.  So the Articles and FDA panel affiliation would be accurate.

My bet on the Orquis press release is they are a very small company and that the title of Medical Director is not a compensated position for the year he is at NIH, this is only speculation but I would doubt this is much more than a labor of love for Dr. Kostam, espically given that he has been with them since 2003 and they are no where close to having a commerical product.

Senator Grassley raises the fact that in 2006, questions raised by Grassley about the practices of an NIH institute leader led to the official’s departure from the NIH.  (if it worked then perhaps it can work again) Grassley also is working to get the National Institutes of Health to meet its obligation as a trustee of tax dollars to do whatever it can to achieve accurate disclosure of the financial relationships between the pharmaceutical and device industry and doctors who conduct medical research with the $24 billion in federal grants awarded each year.

Again the senator is using the tactic of sending out press releases about inquiry letters, this has devastating effects on the physicians in question, and in the end may amount to nothing.

Also on the same day Elias Zerhouni, MD resigned as Director of the NIH, under Doctor Zerhouni, the NIH has increased in size (though not in the last four years due to funding from congress), and instituted conflict of interest policies so that their staff no longer consults or speaks on behalf of industry.  Several newspapers applauded Dr, Zerhouni including the New York Times for his efforts to make the NIH more efficient.

My guess is he has had enough letters from Senator Grassley.

Physician Payment Sunshine: Merck Joins the Act

In a move to give the public more transparency around physician payments and grants Merck announced that starting in October, 2008:

·         Merck will be posting their grants (including CME, patient and Medical Specialty Society Grants) on their home page www.merck.com

·         In 2009 they will be disclosing payments to physicians who speak on their behalf

·         And also in October they will publish the results of their studies regardless of the outcome on www.clincaltrials.gov and www.clinicalstudyresults.org

This move shows that Merck is committed to adopt industry leading standards of transparency.

As more companies announce their commitment to transparency, the public will see first hand the commitment that companies have towards educating patients and physicians. 

These companies should be applauded for their bold moves.

See Merck Full Statement Bellow:

According to Merck:

Merck is committed to industry-leading standards of transparency.  Our Transparency Initiative, launched more than a year ago, includes a number of significant steps that we have already implemented and that we will be implementing over the coming months.  This initiative is intended to respond to stakeholder concerns and public interest in various aspects of our business, and includes efforts to increase transparency in all major aspects of our operations, from research to sales and marketing practices.

Grants:  In October, Merck will begin enhancing transparency of our grants to patient organizations, medical professional societies and other organizations by posting on merck.com grants made by our Global Human Health division to U.S. organizations for independent professional education initiatives, including accredited continuing medical education (CME).  Over the course of 2009, we will expand our disclosures to include other grants we make to medical, scientific, and patient organizations including grants made by The Merck Company Foundation and the Merck Office of Corporate Contributions.

Relationships with physicians:  Merck has also been a leader in endorsing broader disclosure of financial relationships between physicians and industry.  We strongly believe that engagement of the physician community with industry is in the best interests of patients and promotes information sharing and education about the newest medicines and treatments and patient experience.  Merck has endorsed pending legislation offered by Senators Grassley (R-IA) and Kohl (D-WI) mandating disclosure of these financial relationships.  Even in the absence of a legislative requirement, however, we are committed to begin disclosure in 2009 of payments to physicians who speak on behalf of our company or our products.

Clinical trials registration and disclosure: In the area of clinical trials, Merck is also committed to a continuing high-level of transparency.  We believe that clinical trial registries serve an important function for patients and health care providers to learn about and gain access to relevant clinical trials of experimental treatments or preventative agents.  U.S. law requires that all trials Phase II-V must be registered on the ClinicalTrials.gov website; Merck's policy is to register at the trial initiation all clinical trials in patients that we sponsor and conduct worldwide.  As we have for years, Merck also remains committed to disclosing results from registered trials of marketed products, regardless of outcome, on ClinicalStudyResults.org., and beginning October 2008 at ClinicalTrials.gov.

Corporate Responsibility Report:  Merck will publish in October 2008 our new Corporate Responsibility Report which contains additional metrics regarding the company's corporate responsibility performance and future commitments to enhanced transparency.

This move along with Eli Lilly’s announcement yesterday, are significant and we anticipate that more companies will be making similar announcements in the coming weeks. 

Physician Payment Sunshine: No Good Deed Goes Unpunished

Several months ago, I met a young woman who was the chief lobbyist for a well know anti-industry group.  In our discussion she mentioned that her group was in favor of the revised Physician Payment Sunshine Act, because they see it as a first step in their march towards eliminating all pharmaceutical and device marketing.  She explained how this data would be useful in embarrassing physicians not to work with industry.  At the time I shrugged off the comments due to her youth.

This week Eli Lilly announced that as a company they are going to disclose payments to physicians.  At this announcement one who expect accolades from those who have been saying “we want disclosure”.

Senator Kohl the sponsor of the physician payment sunshine act stated: "Eli Lilly is leading the charge for transparency in the relationship between pharmaceutical companies and doctors by fulfilling the obligations of the Physician Payments Sunshine Act before it has been enacted,"  and  "It takes a lot of courage to be the first. They have made a principled decision that I believe will benefit both their business and the consumers of their products."

So what did the anti-Pharma crowd do, did they applaud the effort, like any reasonable person,  absolutely not,  they even went so far as to accuse Eli Lilly of atrocities. 

In one of the most conflicted and prolific of the pharma critics,  Carlat’s Psychiatry Blog  Eli Lilly: Ethical Confusion Continues  Dr. Carlat writes:

So why do I say Eli Lilly is "ethically confused"? Because they still shamelessly participate in marketing deception. They hid risks of Zyprexa from doctors long after they knew about them, and still deny that this was wrong. They continue to fund a malpractice insurance company, PRMS, to provide sham risk management education to psychiatrists in an effort to prevent them from switching patients to less toxic antipsychotics. In this particularly ugly marketing tactic, they are paying attorneys to do their "education," payments which would remain hidden even under their new disclosure policy.

The blog is a case study in that the true goal of the anti-medical manufactures crowd is:

A)    To stop all new drugs from coming on the market

B)     If this drug slips by the FDA disavow and discredit any benefit that a new drug or device may bring

C)   Stop all pharmaceutical marketing.

Dr. Carlat is influential, when I pulled the records from a anti industry marketing hearing at one of the states, it was full of blog postings and articles from Dr. Carlat.

The words of Dr. Carlat once again confirm their true agenda and that no good deed goes unpunished.

Physician Payment Sunshine: Eli Lilly Acts

In a move to provide greater transparency of payments for consulting and speaking to physicians, Eli Lilly Announced today that starting 2009 Lilly will be posting the names and payments to physicians on their website.

At a speech before the Economic Club of Indiana today, Lilly's president and chief executive officer, John Lechleiter, Ph.D., outlined the company's plans to launch an online registry of physician payments in 2009. Lechleiter announced the physician registry as a part of a broader outline on the company's transformation efforts.

"With each of our industry firsts, from launching our clinical trials registry to the public reporting of educational grants, Lilly is striving to be a leader in improving transparency across our industry," said Lechleiter. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Earlier this year, Lilly was the first pharmaceutical research company to endorse bipartisan federal legislation - known as the Physician Payments Sunshine Act - that would establish a national registry of payments to physicians by medical device, medical supply and pharmaceutical companies. The legislation, which was introduced by United States Senators Charles Grassley (R-Iowa) and Herbert Kohl (D-Wisconsin) last September, has not been passed yet by Congress.

Lechleiter added, "Though we remain hopeful that the Sunshine Act will be passed by Congress at some point, Lilly is taking action independently. Being more transparent by opening up our business to the public is an important step to building trust and confidence."

Under the Lilly registry plan, the public will have access to an Internet database listing its payments to physicians. Lilly will launch this registry as early as the second half of 2009. When first launched, its contents will include 2009 payments to physicians who serve the company as speakers and advisors. By 2011, Lilly plans to expand the reporting capabilities of the registry to resemble the Sunshine Act legislation. The registry will be updated annually to reflect the previous year's payment information.

"Eli Lilly is leading the charge for transparency in the relationship between pharmaceutical companies and doctors by fulfilling the obligations of the Physician Payments Sunshine Act before it has been enacted," said Senator Kohl. "It takes a lot of courage to be the first. They have made a principled decision that I believe will benefit both their business and the consumers of their products."

"Lilly is proud of the important and longstanding relationships we have with physicians," said Lechleiter. "Many physicians perform valuable services for the biopharmaceutical industry by advising us on the development of new medicines and giving lectures to other medical professionals to educate them about new treatment options. For these services, they are compensated at market rates. These services help to advance the science related to medicines and are important to both current and future patients who rely on pharmaceuticals as an integral part of their therapy."

"Our primary focus is the well-being of our patients and APA has adopted strict disclosure policies to ensure our patients are informed regarding relationships between physicians and industry," said James H. Scully Jr., M.D., CEO and Medical Director of the American Psychiatric Association. "We applaud efforts by Lilly to ensure there is transparency in their relationships with physicians."

Our industry is doing a lot to help develop life saving medication and devices, this move shows that self disclosure is always better than government interdiction.

Lilly to publicly disclose company payments to doctors by 2009 - (Bloomberg)

Lilly set to become first pharmaceutical research company to disclose physician payments - (Eli Lilly)

Other drug makers may follow Lilly in disclosing payments - (Morningstar)

Eli Lilly to disclose financial ties to doctors, a drug industry first - (The Hill)

Lilly will disclose speaking, consulting fees paid to doctors - (The Indianapolis Star)

Drug maker pledges to report payments to doctors - (The New York Times)

Lilly to disclose payments to doctors (free preview) - (The Wall Street Journal)

Ezetimibe Congressional Investigation: SEAS of Discontent

If you are one of the world’s premier biostatisticians and have a Sir before your name you can pretty much tell Congress thanks but no, thanks.  This is exactly what Sir Richard Peto, professor of medical statistics and epidemiology at Oxford UK did in a Letter to Congress  from The Clinical Trial Services Unit and Epidemiology Studies Unit at Oxford University in the UK.

This was in a response to a series of letters from Congressmen John Dingell and Bart Stupak, Chairman of the Committee on Energy and Commerce, Subcommittee on Oversight and Investigations on August 21, 2008 and September 2, 2008 to the Presidents of Merck and Schering Plough.

In the response letter Dr. Peto outlines the methodology and independence in which he conducted the meta analysis of the clinical trials of SHARP, IMPROVE-IT to review whether the findings of the SEAS trial on increased cancer rates in ezetimibe patients was an anomaly or a trend.

The analysis conducted in seven weeks and published in the New England Journal of Medicine main conclusion was that there was “no credible evidence” that ezetimibe affects cancer.

Congress wanted to know what influence the sponsors of the original trials had on the meta-analysis.

The CTSU outlined how all relevant conflicts of interest were declared, but are of no material relevance to the reliability of this conclusion, for any competent trial statistician would indorse it (the study results).

This is not to say that the analysis is without question, Thomas Fleming, PhD one of America’s top biostatistician pointed out the potential limitations of Dr Peto’s analysis also in the New England Journal of Medicine.

The companies (Merck and Schering Plough) were told that the meta analysis was being undertaken, but did not know the results or receive any draft of his report before it was finalized and sent out by email to the FDA and the European Regulatory Agency on Monday July 21, 2008.

In a response to how the doctors were compensated: Their salaries are not directly or indirectly paid for by industry or industry-sponsored projects.  Moreover, the CTSU has staff policy of not accepting any honoraria, consultancy fees or other payments directly or indirectly from industry.

When requested to turn over all their communications with the supporters since 1998, they replied that it would involve an unreasonably vast amount of effort as CTSU has conducted clinical trials for over ten years involving 60,000 patients each involving extensive correspondence.  And they made clear that: “Such requests seem to constitute inappropriate harassment, if the term “records” is defined as widely as in the attachment.

The congressional staff kept referring to the study as a “consultants study”, at which Professor Peto stated “this is not a consultant’s study”.  Sir Peto kept coming back to the fact that what they conducted, was an independent analysis.

When asked that they make Dr. Peto available for a staff interview as soon as possible, the response was straight forward:  the companies are not in a position to make Professor Peto available since he is a tenured professor at Oxford University and companies have no control over him (though he is available to review data statistical data sets at their request).

The pièce de résistance to the letter was the P.S.

PS: Request that your subcommittee declare its own potential conflict of interest:

Twenty academic coauthors published a careful critique of your subcommittee’s investigation of the breast cancer researcher Dr. Bernard Fisher in the 1990s. (Peto R et al. The Trials of Dr Bernard Fisher: A European perspective on an American episode.

Controlled Clinical Trials 1997; 18: 113; one of the sections is entitled “Inappropriate congressional subcommittee procedures”, see attached article.)

 

Given this, it might well be appropriate for you and any of your subcommittee members or staff to describe this potential conflict of interest when commenting directly or indirectly on the CTSU’s work.

 

Apparently, the same subcommittee in 1994 helped destroy the carrier of perhaps our most successful breast cancer researcher at the time Bernard Fisher, MD over what amounted to no scientific or ethical reason and caused many patients to question their cancer therapy at the time.

 

If you are unfamiliar with Dr. Fisher’s case I encourage you to read the article, it will remind us how a rush to judgment can have catastrophic results.

Dr. Peto reminded congress that independence works both ways.

Relevant documents:

Response to Congressional letters about CTSU work on ezetimibe: September 16, 2008

Attachment to CTSU response: 1997 article entitled The Trials of Dr. Bernard Fisher: A European Perspective on an American Episode

Letters about CTSU from Congressmen Dingell and Stupak

Letter 1: August 21, 2008 

Letter 2: September 2, 2008

Attachment to Letter 2: CTSU 21 July report to the FDA

Attachment to Letter 2 (Tables)

Other relevant links

 CTSU guidelines for honoraria, etc

Peto R et al “Analyses of Cancer Data from Three Ezetimibe Trials.” NEJM 2008: 359 (10.1056/NEJMsa0806603). Available from www.nejm.org

Fleming T  “Identifying and Addressing Safety Signals in Clinical Trials” NEJM 2008 (10.1056/NEJMe0807372) Available from www.nejm.org

Forbes: Sir Peto Defends Vytorin Analysis

Kohl Hearing: DCT for Device - We are Watching

"Every last dime spent on advertising is passed on to the consumer." Senator Herbert Kohl, Wisconsin, stated at a hearing today on DCT Advertising by Medical Device Companies: Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?

Direct to consumer advertising is quite small according to TNS Media Consultants and accounted to only $193 million in 2007.   For Cardiac Medical Devices DTC is a very recent phenomena according to William Boden, MD Chief of Cardiology at University of Buffalo with the first add being rolled out on November 22, 2007 during a Dallas Cowboys – New York Jets game by Johnson and Johnson for the Cypher coronary stent titled “Life Wide Open”.

Three academic researchers and Consumers Union comprised the first panel and presented "evidence" that current DTC for devices was growing and needed further regulation. Although virtually none of their so-call evidence meets current standards for research, no member challenged it. They also want to be the ones who decided how DTC advertising should be done.

Daniel Schultz, MD, Director Center for Devices and Radiological Health, explained how FDA and FTC shared regulatory authority, and how the FDA regulation of restricted devices compared with FDA drug regulation.

 At one point, Senator Kohl asserted "Every last dime spent on advertising is passed on to the consumer." and "Is it time to reconsider that advertising “and ban it like in other countries?  Dr. Schultz reply is "Most consumer advertising is not a bad thing."  He discussed ads for glucose monitors reminded patients to manage their disease and follow their doctors instructions.  Then, "At the end of the day, the decision rests with doctors and their patients." 

Schultz also refused invitations by Kohl to seek more legislative authority. Instead, Schultz said that while he thought regulation of device advertising was important, his job was to manage all device regulation in light of the public health and his available resources. If further resources were given the agency, he said much thought would be required to determine how to regulate it effectively and efficiency.

While not denigrating existing regulation of device advertising, he called into question the value of some current labeling regulation, wondering aloud if the resources spent parsing the words used on labels were well spent.

Key Links to Testimony

Kevin Bozic, MD., Professor of Orthopedic Surgery, University of California, San Francisco, CA

William Boden, M.D., Professor of Medicine and Public Health, University of Buffalo, Buffalo, NY and George Diamond, M.D., F.A.C.C., Senior Research Scientist, Emeritus, Cedars Sinai Medical Center, Los Angeles, CA

Ruth Day, Ph.D., Director, Medical Cognition Laboratory; Senior Fellow, Duke Aging Center, Durham, NC

Ami Gadhia, Policy Counsel, Consumers Union, Washington, DC

Daniel Schultz, Director, Center for Devices and Radiological Health, Food and Drug Administration, Washington, DC

Stephen Ubl, President and Chief Executive Officer, AdvaMed, Washington, DC

Articles:

New York Times

Letters from Grassley: Pawns in a Chess Game

Senator Grassley is putting the pressure on the National Institutes of Health to beef up their enforcement of disclosure rules for those working on NIH research grants ($23 billion/year), including pulling funding from one or two grants to set an example to all other institutions receiving grants.  According to the Wall Street Journal, the senator’s staff met with the director of NIH, Elias Zerhouni, this past Tuesday to again discuss enforcement of these rules.

Senator Grassley has been quoted as saying: "Starting today, the NIH could send a signal that business as usual is over ... The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

As part of applying pressure on NIH to beef up their enforcement, the Senator is taking to bi-monthly floor speeches singling out physician researchers who he believes are not following the disclosure rules.

Unfortunately, it isn’t clear that all the facts are collected and verified before he “exposes” yet another researcher in psychiatry.  This isn’t a Senate hearing where the researcher has a chance to prepare and respond – this is a surprise attack where you wake up one morning and discover your name in the news, linked to words like “illegal” or “unethical.”

The Senator’s staff has done some simple extrapolating asking pharmaceutical and device companies to report the funds they paid for research, consulting and speaking and comparing that with information that the physicians submitted to their institutions.  In some instances the institutions did not require disclosure until recently which explains some of the discrepancies in the data.  In some cases the institution’s reporting system asks for ranges, and in other instances the faculty member in all likelihood did not either understand the request and information about this issue by the institutions was weak or even non existent or they did perhaps fail to register but all those instances are unclear. 

The two pawns in the Senators chess game with NIH this week include two important Texas psychiatrists Karen Wagner, MD, Ph.D. and John Rush, MD both prominent researchers from Texas.

In the case of Dr. Karen Wagner, a professor at the University of Texas Medical Branch at Galveston: “Dr. Wagner was one of the authors on a Paxil study known as Study 329. This study was published in 2001”.

We pulled the study  and it actually has a name (Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial) and Dr. Wagner was the listed 18^th on the author list, which means she was not a writer but rather a study center, and not necessarily involved writing the in the transcript but a review.  Just for the reference, the most important authors on a paper are the first and last author, the first author is the principal investigator and writer of the study results and the last author is typically the coordinating study center or lab. 

 

The senator found a connection with a class action suit:  Study 329 was cited in a New York (Hoorman vs. GSK) case where GlaxoSmithKline was charged with “repeated and persistent fraud).” Part of the case against Glaxo was that the drug company promoted positive findings but didn’t publicize unfavorable data.  

In March 2006, Dr. Wagner was being deposed in a case on Paxil. During that deposition, Dr. Wagner was asked how much money she had taken from drug companies over the previous five years.

“Her response?  She said, and I quote, “I don’t know.” In fact, she testified that she

couldn’t even estimate how much money she received from the drug companies.”

 

Perhaps she did not want to give a wrong number and then be in real trouble for lying under oath, can anyone here tell me how much they paid in taxes in 2000 and be able to answer honestly under oath?

 

According to Glaxo, they paid Dr. Wagner over $53,220 in 2000. In 2001, when study 329 was published the company reported paying her $18,255.

 

During many of these years, Dr. Wagner has led NIH-funded studies on depression.

These studies involved Paxil and Prozac; an antidepressant made by Eli Lilly. Eli Lilly reported to me that they paid Dr. Wagner over $11,000 in 2002. However, Dr. Wagner did not disclose this payment to the University of Texas.

 

Apparently, the University of Texas Medical Branch didn’t require their physicians to

disclose their financial relationships with the drug industry, until around 2002. But

federal guidelines from 1995 are clear that researchers need to disclose this money when they take a grant from the NIH.

 

This is interesting the Senator pummels the doctor for not reporting income that was not required to be reported by her University.  If this is the case, even if she reported it where would they put it?

 

What makes this even more interesting is that from September 2003 through August

2004, Dr. Wagner was a voting member of the Conflict of Interest Committee at her

university. That’s right, she was one of the university’s experts on conflicts of interest

during the same time that she was not reporting her outside income.

Much of this probably falls on the University what he is saying sound sinister but perhaps much of this is miss understanding as opposed to malfeasance.

The other doctor pummeled is:  Dr. Augustus John Rush is a psychiatrist at the University of Texas Southwestern Medical Center. During 2003-2005, Dr. Rush received an NIH grant to conduct a clinical training program. This program helped trainees understand how to conduct proper clinical trials and also dealt with medical ethics.

 

However, just two years before getting this federal grant, Dr. Rush failed to report all

of the money that Eli Lilly paid him. Dr. Rush disclosed $3,000 in payments from the

company, but Eli Lilly tells me that they paid Dr. Rush $17,802 in 2001.

 

It is possible that this was a mistake, as this was two years prior to the NIH grant, not a violation of Federal rules as the senator suggests.

Taking researchers to task one or two at time to move the NIH, without a chance for rebuttal, goes against the American spirit of fairness.  Wouldn’t a debate be better than the one sided attacks we are now seeing, these researchers have devoted their lives to helping patients, exposing them on what may account to a reporting error doesn’t make sense.

Key Links:

Grassley Floor Statement

Letter to University of Texas System

Doctor John Rush Disclosure

Doctor Karen Wagner Disclosure

Pharmalot Stories: Grassley and Texas Academics Take 2, Grassley Targets Another Academic of Conflict of Interest

Wall Street Journal Story: Pressured, Schools Review Ties to Drug Firms

Wall Street Journal Blog: Sen. Grassley Blasts Psychiatrist for Failure to Disclose Industry Funding

Articles on Previous Grassley Letters in his investigation into Psychiatry:

Letters from Senator Grassley: Gone Fishing on the APA

Grassley: Letters on NIH Conflict of Interest

Letters from Senator Grassley: A Scarlet Letter

Grassley: Disclosure or Public Humiliation

ACCME Call for Comment: Listing of Published Comments

ACCME Call for Comment: Organizations Respond

The ACCME recently stated in a letter to NAAMECC: ACCME will make public without attribution some of the information submitted in response to its request for comment, in the form of summaries and extracts, as opposed to verbatim submissions.

 

However, we cannot commit to posting these summaries and extracts immediately upon receipt of the written comment.

We are going one step further than the ACCME and listing as many comments to the ACCME’s call for comment as possible.  When comments come available we will be posting them on www.policymed.com:

The Coalition for Healthcare Communication

North American Association of Medical Education and Communication Companies (NAAMECC)

Washington Legal Foundation (WLF)

Editorial in Journal of American College of Cardiology (JACC)

The Alliance for CME

Potomac Center for Medical Education

Bio Technology Industry Organization (BIO)

PhRMA

Amgen (new)

Pfizer

American Academy of Family  Physicians  (AAFP) (NEW)

The Association for Hospital Continuing Medical Education (AHCME)

The Society for Academic Continuing Medical Education (SACME)

Council for Medical Specialty Societies (CMSS)

            June Call for Comment

August Call for Comment

Public Citizen

Thanks to everyone who accessed this site, because of our efforts and those of the Alliance for CME and NAAMECC,  The ACCME has published all the comments:

ACCME Call for Comment: Access to all Responses