Policy and Medicine

Grassley: Letters on NIH Conflict of Interest

This past week, Senator Grassley sent letters around Capitol Hill calling on Congress and NIH leaders to identify conflicts of interest in taxpayer sponsored medical research.  He outlined that:

“There’s mounting evidence that the NIH hasn’t done due diligence in keeping track of industry payments to medical researchers”, Grassley said. “With the objectivity and integrity of research at stake, along with public trust in the system, there are plenty of reasons for Congress to step in to establish penalties for grantees who fail to report financial conflicts and to bring transparency to taxpayer funded medical research.”

Current federal law requires the NIH to monitor financial conflicts of interest by requiring the institutions who receive grants to collect and manage information on the money that their researchers receive from drug and device makers and others in industry. Recent reports have revealed that this tracking is not happening in individual cases. In addition, the Inspector General for the Department of Health and Human Services reported in January that the NIH does not adequately monitor its extramural grants for conflicts of interest. Extramural research is research supported by funds from the NIH for researchers and organizations outside the NIH through a grant, contract or cooperative agreement.

Grassley said that NIH leaders need to send a clear message that hiding conflicts of

interests due to either sloppiness or sneakiness will not be tolerated. “The monetary value and prestige of NIH grants is significant enough that the possibility of losing a grant for not complying with reporting requirements ought to be a strong incentive to follow the rules,” he said. With almost $24 billion in NIH research grants awarded this year, Grassley said that he hopes lawmakers with primary responsibility for directing those funds will also step in and make the rules meaningful and shed light on what’s happening.

He did acknowledge that the Director of the NIH pledged to “significantly enhance the identification and management of FOCIs (financial conflicts of interest)” in a June 20, 2008 letter to Grassley. The Director also said that NIH is considering gathering public comments to modify the regulations that govern NIH extramural grants.

In an earlier New York Times article, Dr. Norka Ruiz Bravo, the institutes’ deputy director for extramural research stated: “For us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible”.  

She believed that the system was nonetheless working well. The health institutes conducted an audit in 2006 of 18 sites and found numerous problems with the way universities handled conflicts of interest, particularly with how well they took account of financial conflicts that arose after a grant was awarded.

“I think it is working to the extent that people are being honest,” Dr. Ruiz Bravo said, “and I think most people are honest.”

Dr. Ruiz Bravo said the health institutes would soon mandate that the institutes and centers provide her office with a report about each conflict reported to them by universities. But, she said, these reports will still lack details about the conflicts and how they are managed.

It is clear that the NIH needs to provide more oversight on managing conflict of interest, but they are not absent as the Senator suggests.  Just how intrusive those will be is up to NIH and Congress.

For key documents:

Press Release from Senator Grassley calling on Congress and NIH leaders to identify conflicts of interest in taxpayer sponsored medical research

Zerhouni response to Grassley's June 4th letter

New York Times story, Researchers Go Unchecked, Report Says

HHS OIG – Report: National Institutes of Health: Conflicts of Interest In Extramural Research

New York Times story, Researchers Fail to Reveal Full Drug Pay

Letter to Senate Appropriations Committee Chairman and Ranking Member

Letter to Senate Labor-HHS Subcommittee Appropriations Chairman and Ranking Member

Letter to House Appropriations Committee Chairman and Ranking Member

ACCME Senator Kohl Get's in the Act

The ACCME received a letter from Senator Kohl, Chairman of the US Senate Special Committee on Aging, concerned about the size of support of CME from commercial supporters, the perceived influence they may have on physician prescribing patterns.

In particular they are concerned with CME courses to encourage physicians to use their products for potentially controversial medical practices.

Apparently one company is supporting CME around herpes tests for pregnant women, a practice that is not supported by ACOG, CDC or the US preventive services taskforce.  According to the Senator the anti viral therapy is potential dangerous to the baby.

“I am troubled by any attempt to persuade physicians to use a drug treatment for any reason other than the patient's condition and the drug's effectiveness in treating it.”

Therefore, it was with great interest that the Committee took note of the ACCME's credentialing standards and practices for CME courses.

“In an effort to better understand the ACCME's credentialing standards and practices for CME courses, please provide us with the following documentation and information:

1.) a copy and written description of the accreditation process for CME courses;

2.) any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content;

3.) any mechanisms the ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and

4.) any further plans the ACCME may have in place to develop such mechanisms.

Please respond fully to this request by close of business on Friday, July 7, 2008.”

The ACCME and their providers have gone to great lengths to ensure the scientific validity, and no undue influence by industry and are currently working to strengthen their system even further.  The Senator should be pleased by what he receives from the ACCME.

Letters from Senator Grassley: A Scarlet Letter

In a letter from Senator Grassley to Stanford University covered by Businessweek, Drugmakers and College Labs: Too Cozy? and the Wall Street Journal Blog, Grassley Questions Stanford Psychiatrist’s Industry Ties .

The Senator alleged in the Congressional Record that the Chairman of the Department of Psychiatry at Stanford, Alan Schatzberg, MD failed to report to Stanford some payments from 2000 to 2006 from Eli Lilly (LLY) and Johnson & Johnson (JNJ) for consulting and other services.

Grassley also chastised Dr. Schatzberg for not fully informing the university about the value of his personal stake in a drug development company he co-founded—although the psychiatrist appears to have followed Stanford's disclosure rules.

"I am concerned that Stanford might not have been able to adequately monitor the degree of Dr. Schatzberg's conflicts of interest," Grassley said in a June 23^rd letter to Stanford President John Hennessy that was published in the Congressional Record. The senator suggested the university reexamine its disclosure policies.

But a letter from Stanford to Senator Grassley shows that he did in-fact, disclose his payments from both Elil Lilly and Johnson and Johnson, and that the Senators staff had perhaps made a mistake:

1. Statement that Dr. Schatzberg had not disclosed a $22,000 payment from Johnson & Johnson in 2002. Dr. Schatzberg did disclose this payment to the University and reported it to the Committee. He disclosed the $22,000 payment from Janssen, the wholly-owned subsidiary of Johnson & Johnson that made the payment.

2. Statement that Dr. Schatzberg did not report the $52,134 that Eli Lilly disclosed for 2004; however, Dr. Schatzberg disclosed three different sources of compensation from the company for that year: less than $10,000 for advisory board, $10,000 to $50,000 for consultation, and $10,000 to $50,000 for honoraria. Together, this disclosure fully accounts for the 2004 payments from Lilly. A chart attached to the letter states that Dr. Schatzberg had not disclosed receiving a payment from Eli Lilly in 2007. That is simply an error. Dr. Schatzberg did disclose that payment, both to Stanford and to the Committee.

3. Other discrepancies noted in the letter may be the result of differences in record

keeping between Stanford and pharmaceutical companies, the fact that companies' fiscal years may differ from Stanford's and misunderstandings by the Committee.

In a follow-up letter Stanford stated:

“Schatzberg did disclose in writing his ownership of the Corcept stock and its actual value, so Stanford did know the value of his stock based on his disclosures to the university.” 

According to another article in CBSNews.com, Senator Grassley is investigating some 20 top medical schools – including Harvard, Stanford and the University of Cincinnati “for under reporting the income top researchers are getting from the drug industry.”

Senator Grassley is using this information to promote his Physician Payment Sunshine Act .

In his floor statement, the Senator opens about one other doctor who reported $10,000 when in fact he received $14,000, a four thousand dollar difference between the University and the company, hardly the stuff to condemn a man from the floor of the senate.

In the interest of fair play we encourage Senator Grassley and his staff to verify with the institutions and physicians in question prior to publishing their names and offenses in the Congressional Record. It is the least we owe these dedicated researchers if we want others to go into the research in the future.

Medicare Bill 2008: Update

On June 25 2008 - The House has passed a bill just in the nick of time that will result in Medicare payments to doctors not being cut, as was originally planned to be the case.

Doctors who treated Medicare patients were about set to be paid an average of 10% less in forms of reimbursements by the government, a fact that would've caused quite an uproar.

The bill was passed by a vote of 355-59, a fact that will result in doctors who treat Medicare patients not receiving less reimbursement money.

Instead, the money will be taken from money given to private health insurance companies, a fact that will ruffle their feathers quite a bit.

It is estimated that in the US more than 600,000 doctors treat patients on the Medicare program. Reimbursement rates were to be adjusted as of July 1, in conjunction with the exceeding of targeted spending goals.

President Bush has stated that he will veto the bill if it makes it out of the Senate

Last night the Senate failed to get the 60 votes to invoke cloture and end debate, thereby stopping the bill, the vote was mostly along party lines with 9 Republican's voting in favor of the bill:

http://www.senate.gov/legislative/LIS/roll_call_lists/roll_call_vote_cfm.cfm?congress=110&session=2&vote=00160

CQ Updates has a good analysis of the situation

To give you some background on the love going around the Senate, you have to read this evenings consecutive press releases by Senator Grassley::

Thursday June 26, 2008

7:51pm

Senator Grassley just delivered the following statement.

Floor Statement of U.S. Senator Chuck Grassley of Iowa

Ranking Member of the Committee on Finance

Cloture motion on H.R. 6331, the Medicare bill

Thursday, June 26, 2008

Mr. President, here we are again.  Once again, the Senate is being asked to vote to proceed to a bill written on a partisan basis.  Once again we are being asked if we want to agree to a process where no amendments are allowed.  Once again we are being told to “take it or leave it.”

The damage this is doing to the ability of this body to function is extraordinary.  It shouldn't be this way.  It doesn't have to be this way.

During the last several years, the Finance Committee has produced numerous bipartisan health care products.  In 2003, Senator Baucus and I joined together, defied the long odds against us, and produced a Medicare Prescription Drug bill.  In 2005, we worked together on a relief package in the aftermath of Hurricane Katrina.  In 2006, we passed the Tax Relief and Health Care Act.  In 2007, we worked together on a bipartisan SCHIP reauthorization bill.  We also passed the Medicare, Medicaid, and SCHIP Extension Act of 2007.  For years, the Finance Committee has been the model of how a committee can work on a cooperative, bipartisan basis.

I think we work best when we work together.  For some reason, that hasn't seemed to be the case this year.  I've tried to work this year to get a bill that could get signed into law.  I personally think the White House has drawn lines in the sand that are unreasonable.  However, the President holds the veto pen, and if this bill passes today, we will see it used.

I tried to work towards a bill that could get signed.  Obviously, that was not a path the majority could follow.  Even after the first cloture vote failed in the Senate, I tried to get a bipartisan compromise that could be signed into law.  That effort was abandoned when the House voted to support the bill that the Senate couldn't get cloture on.

When we were in charge around here, I can say we certainly didn't appreciate it when the House Ways and Means Committee tried to dictate terms to the Senate.  When Ways and Means Chairman Thomas tried to roll the Senate, I defended the bipartisan Senate position.  When I was Chair of the Finance Committee, I don't recall our bipartisan efforts being determined by House votes.  To the contrary, I think we worked together in spite of House votes.

And let's be clear about another thing.  The House vote went the way it did because members were assured the Senate was going to fix the problems in this bill.  They are counting on us to fix it so we have a bill the President will sign.  They are right about one thing though; this bill does need to be improved.   

The bill that the Democrats are trying to pass is woefully lacking in what it provides rural America.  I'd like to call out one specific provision.  Senator Harkin and I have worked extensively on a provision for the so-called “tweener” hospitals.  These are hospitals, which are too large to be critical access hospitals, but too small to do well under current Medicare payment systems.  We had a provision to improve payments to these hospitals, but it's not in the House Democrats' bill.  A vote for cloture misses an opportunity to provide critical assistance to rural hospitals all over this country.  I'm sure Senator Harkin and others are as disappointed as I am by this omission.

Voting for this bill accomplishes nothing.  It won’t become law.  How much clearer can we be about that?  To keep the pay cut for doctors from happening, we have to defeat this motion so that we can sit down and finally produce a bill that can become law.  To improve Medicare, we have to produce a bill that can become law.  To make sure beneficiaries continue to have access to essential therapy services, we have to produce a bill that can become law.  To help beneficiaries, we have to produce a bill that can become law.  To preserve access to durable medical equipment for seniors, we have to produce a bill that can become law.

We have to be allowed to do our work in the U.S. Senate.  We have to be allowed to produce the best bill possible through bipartisan compromise.  Let's show that we can still work on a cooperative basis.  We have to defeat this motion so that we preserve the right of the Senate to have input on legislation, that we aren't simply a rubber stamp for the House.  We should defeat this motion so we can show that bipartisanship is not dead on important health care issues that matter to millions of people who depend on us as stewards of Medicare.

So let's do the right thing and vote no.  Vote no so this body does not abdicate it duties under the Constitution.  Vote no so we can get a bill done this week that can become law.  Vote no so we can get the job done.  A yes vote accomplishes nothing today.

Thursday June 26, 2008

9:34pm

Sen. Chuck Grassley, ranking member of the Committee on Finance, made the following comment after the Senate failed to invoke cloture on the House Medicare bill and the Senate majority leader blamed Republicans:

"The Senate leader's take-it-or-leave-it approach and on-the-floor election-year calculations hurt doctors and seniors.  It's past time for the Senate to act responsibly and work out a bipartisan bill to avert an unfair cut in the reimbursement rate for doctors who treat Medicare patients."

Grassley: Disclosure or Public Humiliation

That is the question we are considering about this Sunday’s New York Times.  In an article Researchers Fail to Reveal Full Drug Pay reports that several well known psychiatrists are under scrutiny from Senator Grassley and possibly the government and their institutions for failing to disclose the extent of their relationships with industry. 

Senator Grassley’s statement in the congressional record describes a system of extrapolation for collecting the data. It included requests for information on payments to specific physicians from the supporters, institutions and the physicians themselves. 

Senator Grassley has a two-fold purpose for the release at this time:

A)   To send a message to NIH that they need to revamp their system of managing conflict of interest.

B)   To promote the Physician Payment Sunshine Act which is expected to be voted on in the coming weeks.

In a letter to NIH Senator Grassley starts out very critical of the institute:

Over the past number of years, I have become increasingly concerned about the lack of oversight regarding conflicts of interest relating to the almost $24 billion in annual extramural funds that are distributed by the NIH.

He is asking NIH to send over records for specific doctors outlined in his statement along with the names and records of any doctors who have been disciplined for failure to disclose.

Some examples of Senator Grassley’s seams very concerned with the quality of the disclosure he requested from Harvard physicians who are receiving remuneration for NIH grants.

The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money
they were making. But by looking at them, anyone would be led to believe that these doctors were not taking much money. Over the last 7 years, it looked like they had taken a couple hundred thousand dollars.
 

But last March, Harvard and Mass General asked these doctors to take a second look at the money they had received from the drug companies. And this is when things got interesting.

Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.
 

The question you might ask is: Why weren't Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.

Based on reports from just a handful of drug companies, we know that even these millions do not account for all of the money. In a few cases, the doctors disclosed more money than the drug companies
reported. But in most cases, the doctors reported less money.

“In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.”  

There are other more fuzzy numbers -- rather than specific how much was received for what services, which would look a lot less nefarious, the article states that Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007; making the amount over $1million over 8 years to look impressive. Buried also is that in 2000, Dr. Biederman reported to Harvard that he received $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, not exactly enough to condemn a great scientist.  Having worked on campaigns, I am sure if checked the records from donors to the senators campaign in 2,000 you would find similar discrepancies.  .” (Peter Pitts in his column Gardiner and Grassley McCarthyite Mugging of Joe Biederman thinks this may be just bad bookkeeping)

It is interesting that the Times acknowledges Dr. Biederman’s accomplishments:

“Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. “

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

It is also interesting to note that they go out of their way to bring in critics including one from a fringe group the Alliance for Human Protection.

Using the Congressional Record and New York Times to embarrass researchers may serve a purpose, but is the court of public opinion the place to air these matters.  There is no evidence to lead us to believe that the Senator or the times ever met or interviewed these physicians to gain an understanding of their position.

This exercise shows how important it is for physicians to keep track of the remuneration they receive from industry for research, consulting and speaking.  It is no longer good enough to give ball park estimates especially if they are working on NIH supported grants.

Senator Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings and requesting even more additional information.  He placed the letters along with his comments in The Congressional Record.

Copies of documents are available by pressing the following links below:

Grassley Floor Statement June 4 2008

Grassley Letter to NIH June 4 2008 

Grassley Letter to Harvard June 4 2008 

Selective Disclosures for Harvard Doctors

Sunshine in the Senate - Organizations Line Up Behind it

PhRMA and AvaMed and several companies including  Merck and AstraZeneca line up behind revised Physician Payment Sunshine Act. 

In addition to press releases the organizations sent letters to Senator’s Grassley and Kohl announcing their endorsement: PhRMA’s endorsement letter  AdvaMed’s endorsement letter.  This is following up from Eli Lilly’s endorsement last week.

Senator’s Grassley and Kohl see these endorsements as very positive:

This movement toward transparency is good for the system.  It fosters accountability by empowering consumers and other watchdogs,” Grassley said.  “The kind of support that continues to grow from industry leaders contributes in an important way to achieving new nationwide requirements.  Requiring disclosure of payments to doctors doesn’t mean that anything has to change, and if there’s nothing to hide, there’s no reason to worry.  The legislation we’re working to get passed would apply to drug makers and medical device manufacturers of every size.  It would make information about payments to doctors, and not just big payments, available to the public in a user-friendly way.  It builds on and improves the important state-level

initiatives that revealed important concerns and set the stage for federal reform.”

This is different that the previously introduced Act in that:

·         Reporting Starts in 2011 vs. Immediately

·         Excludes gifts and consulting of less than $25.00 and requires reporting of aggregate of over $500/year.  Previously required reporting of all gifts over $25.00

·         Limits fines to $50,000/year for non intentional violations and $250,000/year for intentional violations

·         Requires reporting by all companies regardless of revenue, previous bill applied to companies with revenue of $100 million or greater.

·         Provides pre-emption of state laws, so that current state laws on disclosure would be invalidated upon enactment of this law.

·         Delayed reporting for product development and clinical investigations by two years, this proprietary research.

·         Exempts

o   Sample

o   Educational materials for patients

o   Training and other Education

o   Transfers not acting in a professional capacity

o   Loans for equipment purchases

o   Warrantees

o   Discounts

o   Anything bellow $25.00 indexed to CPI

o   In kind items used in charity care

So what does this mean for CME?

Education is included in the first section only to capture education that is not intended for patient benefit. Education intended to benefit patients is excluded.

We understand this may exempt CME – in that that companies only have to report direct payments to physicians/physician practices, as well as payments that are directed by a physician to another entity or on behalf of a physician. 

So if a company is directed by Physician A to make a payment to a CME provider, that would be reportable.  If a company makes a payment to a CME provider to specifically pay for the attendance of Physician B, that would be reportable.  But if a company makes a payment to a CME provider that is for general use by the CME provider and is not tied to a specific physician, that would not be reportable.  We are working to gain further understanding of this issue.

This is a much different track than the House version, which would have no limit on fine, includes CME and would eliminate tax exemption for marketing upon the first violation weather intentional or not.

For other articles we have written on this topic:

Physician Payment "Sunshine -Version 3.0"

House Introduces Sunshine Act – adds guilt by association and one strike and your out.

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.

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

House Introduces Sunshine Act – adds guilt by association and one strike and your out.

The house introduced their version of the Physician Payment Sunshine Act on March 14^th

PPSA has the purpose of requiring manufactures to report all “gifts” to physicians.  In the both versions the definition of gifts includes: any compensation, gift, honorarium, speaking fee, consulting fee, travel, discount cash rebate, services, participation in medical conferences, continuing medical education, other educational or informational program or seminar.

The house version differs from the senate version in the following ways:

Added in the definition of gifts:

Payments to a covered organization that a physician has a significant membership interest (A voluntary paying member or receives professional certification through such organization) this covers all medical societies and most voluntary health organizations with paying professional members.

Funded Research (such as lab-based, epidemiology, or health services research) that is not a clinical trial.

Dividend, profit distribution, stock or stock option grant, or any ownership or investment interest held by a physician in a manufacturer.

Reporting of payments or other transfer of value for clinical trials

Reduced the size of the companies that have to report from 100 to 1 million in revenue

Amends the Internal Revenue Code to prohibit tax deductions for the advertising, promotion, or marketing by manufacturers of drugs, devices, and medical supplies on whom a penalty is imposed for failing to meet the requirements of this Act.

A side by side comparison of the versions House and Senate Comparison PPSA

Links:

DeFazio Press Release

House Bill HR5605 and Status

Senate Bill S2029 and Status

Companies Respond to Grassley Request for CME Grants Disclosure

In February Senator Grassely requested information from sixteen pharmaceutical and device manufactures around the issue of disclosure of CME grants,  the companies got back to him and with a few exceptions most of the respondents answered that they were launching their disclosure systems soon or in the process.

On  Friday April 11^th, Senator Grassley issued the following statement

Right now, Senator Grassley does not plan to pursue disclosure legislation separate from the Physician Payment Sunshine Act. He will carefully monitor implementation of the disclosure plans described in these letters and consider additional initiatives, including legislation, if transparency is not achieved.

“When it comes to the drug and device industry, the stakes are high for both public safety

and the public purse. Making information about financial relationships open to scrutiny is the

right thing to do. More transparency can do a lot to build confidence in the system and bring

greater accountability,” said U.S. Senator Chuck Grassley of Iowa.

Responses from pharmaceutical drug and device makers to Grassley request for disclosure of support for continuing medical education

Copies of letters that Senator Grassley received from drug makers in response to his request from them to follow Eli Lilly’s lead and disclose financ