Life Science Compliance Update

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3 posts from March 2008

March 19, 2008

IOM – Committee on Conflicts of interest:

On March 13th, the IOM held their third meeting of the Committee on Conflicts of Interest here is a link to the agenda and copies of the statements presented at the meeting http://www.iom.edu/CMS/3740/47464/49428.aspx

Favorite Quote: David Korn, MD Senior Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges

If I was an individual from outer space and didn’t really know anything about all of this—I would say that these conversations demonize Industry”.

Several organizations prepared responses and press releases to help influence the committee including NAAMECC and the Coalition for Healthcare communications.

NAAMECC : http://www.naamecc.org/News/tabid/56/Default.aspx

Coalition for Healthcare Communications http://www.cohealthcom.org/content/library/cc/IOM_CME_Conflict_Mar08.pdf

March 18, 2008

Letters from Senators

Letter by Senator Kohl to Schering Plough on Sales Program and Promoting the Hearing

http://aging.senate.gov/record.cfm?id=294743

Press Release by Senator Grassley to Pharmaceutical Companies requesting online reporting of CME grants similar to Eli Lilly System.  (includes letter to companies)

http://finance.senate.gov/press/Gpress/2008/prg022608.pdf

Press Release from Senator Grassley on AAMC’s COI information

http://finance.senate.gov/press/Gpress/2008/prg022808a.pdf

Press Release Senator Grassley on support of PPSA

            http://finance.senate.gov/press/Gpress/2008/prg022708.pdf

This month the senate was busy writing letters, bellow is a link to several that you may find interesting.

March 12, 2008

Government Drug Reps -- What will they think of Next

US Senate Select Committee on Aging: Hearing March 12, 2008.

Under the Influence: Can We Provide Doctors An Alternative To Biased Drug Reviews?

This is a Summary of some of the information presented at the meeting to watch the presentations and read transcripts of the presenters: http://aging.senate.gov/hearing_detail.cfm?id=294598&

In Attendance: Senators Herbert Kohl, WI Chairman (Whole hearing),

Claire McCaskill (End),

Gordon Smith, Oregon (Beginning)

Senator’s Kohl’s opening statement was as follows:

1. Pharmaceutical conflicts of interest, marketing and educating doctors contribute to the rising costs of pharmaceuticals

2. Sales representatives are some of the only ways doctors can learn about drugs

3. There is considerable confusion between selling and educating the doctors

4. Academic detailing is better than pharmaceutical selling:

1. Information presented by pharmacist

2. Combat a full array of pharmaceutical marketing

5. Older generic drugs are better than newer drugs

Norvasc – 4th most prescribed drug, monthly cost of Norvasc $60/month versus $10 dollars for generic … (Someone on the senator’s staff forgot that Norvasc has been generic for over a year)

6. Academic detailing would save $$ (this is the real issue)

Chairman felt he had a comprehensive panel

Shahram Ahari, former Eli Lilly pharmaceutical sales representative, El Cerrito, CA

Out of industry for 8 years, discussed the abuses he saw 8 years ago. Prolific writer and speaker on the subject (mostly to medical student associations on PharmaFree Days), has made a name for himself by speaking about past industry abuses.

http://www.law.columbia.edu/null?&exclusive=filemgr.download&file_id=12201&rtcontentdisposition

Key quotes:

I was recruited fresh from college with an eager desire to employ. My degree is in molecular biology and biochemistry. Shortly after my hiring, it became clearly apparent that a drug sale had much more to do with establishing personal relationships than it did with understanding the latest science.

To sell pharmaceuticals means convincing doctors to prescribe your product more than your competitors despite what might be the more suitable drug for the patient.

He focused on practices prior to the Pharma Code, prior to any reforms that have taken place over the last ten years. This is disconcerting because it means that we have not done a good job of teaching policy makers that significant changes have taken place.

The bulk of his presentation centered on recruitment, training, pairing, tools of the trade, samples, prescriber data, personal client information, the use of thought leaders, gifts, culture and why he left (kind of leaving out being offered a job at UCSF to work in research which is first love); also some recent research from 1992 and 2001.

Jerry Avorn, Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, MA

In addition to his day job at Harvard he runs organization: Independent Drug Information Service www.rxfacts.org which has contracts with the State of Pennsylvania to run their academic detailing pilot project. He also seems to have a better Wiki posting than the President of Harvard.

http://en.wikipedia.org/wiki/Jerry_Avorn perhaps when he is not detailing doctors he is posting his biography.

His key quotes are as follows:

Back in 1979 (he has been at this for a while), I wrote a grant to the federal government proposing the following idea: What if we could take the very sophisticated communications and behavior-change tools that the drug companies deploy so effectively, but instead use them to give doctors the latest and best facts about drugs’ comparative efficacy, safety, and cost effectiveness?

My colleagues and I trained pharmacists in four states to go visit physicians as “un-sales reps,” so they could provide doctors with educational outreach about several common prescribing topics. I named the approach academic detailing because it used the “detailer” approach of sending someone to meet with a doctor in his or her own office to discuss a given drug topic, but we did it from a non-commercial, “academic” perspective We showed that the concept worked in a large four-state randomized trial involving over 400 doctors. As we reported in The New England Journal of Medicine, (We looked it up) (Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing Volume 308:1457-1463, June 16, 1983) 92% of the doctors who were offered this service accepted it, and those who were randomized to the academic detailing group significantly improved their prescribing. In a

formal benefit-cost analysis, we found that such a program could save $2 for every $1 it cost to run.

This was not a surprise; it’s how the drug companies move prescribing in the directions they want. They know exactly what they’re doing. Since then, many additional studies have shown that academic detailing programs can improve the use of a wide variety of drugs, from antibiotics to sedatives, in settings from primary care offices to teaching hospitals to nursing homes. Some of these programs have also tracked clinical outcomes, and have found that patient outcomes also improve – as expected – with more evidence-based prescribing. Today, academic detailing services have been set up in England, the Netherlands, several Canadian provinces, and the entire nation of Australia. In the U.S., some integrated health care systems, particularly Kaiser, have mounted their own academic detailing services, and programs of varying size have been established or legislated in Pennsylvania, South Carolina, the District of Columbia, Vermont, New Hampshire, Maine, and other states. (He failed to discuss just how small these efforts have been, after 30 years of trying to get this venture off the ground and only 12 sales reps)

Allan Coukell, Director of Policy and Strategic Communications, The Prescription Project Group, Boston, MA

The Prescription Project is led by Community Catalyst (funded by class action settlements) in partnership with the Institute on Medicine as a Profession. The Project is funded by the Pew Charitable Trusts, the Project seeks to eliminate conflicts of interest created by industry marketing by promoting policy change among academic medical centers, professional medical societies and public and private payers. In addition the Project will advance state and national level policy solutions.

His testimony centered around the same 25 year old study in NEJM. Pennsylvania, Australian and other studies (no details other than that they aged up the dollars to year 2,000). All around cost savings and nothing on patient benefit.

Nora Dowd Eisenhower, Secretary, Pennsylvania Department of Aging, Harrisburg, PA

The only state actually supporting academic detailing in a pilot with twelve representatives in some key areas in Pennsylvania

Also cost savings testimony but she had no data to share including the cost of her program.

Ambrose Carrejo, Assistant Director, Pharmaceutical Contacting and Strategic Planning, Kaiser Permanente, Livermore, CA

Kaiser does their own counter detailing to encourage the use of generic drugs and keep the cost of Kaiser’s expenses on drug benefit to a minimum.

Everything was around cost savings “80% of all prescriptions written by Permanente physicians nationally are for generic drugs.” “This saved our members and organizations many of millions of dollars”. Kaiser has a fleet of “Drug Education Coordinators”.

By far the most credible witness, he discussed the savings to Kaiser by this process eliminating 80% of Vioxx prescriptions using patient a at risk patient selection criteria.

Questions for the panel centered on the success of the program and what else could be done. Senator Kohl was clearly coaching this group by asking only questions that helped the cause of academic detailing and puts industry practices in a poor light

One interesting note is that Senator McCaskill, asked questions about the FDA’s proposed rule to allow the distribution of studies printed in journal articles. She added ”Talking about wild wild west already – taking sheriff out of town“. She also was on a plane recently with pharmaceutical reps sitting around her and “felt old and fat”. She overheard a comment that … you have it easy you work with psychiatrists.

The panelists were asked at the end what else could be done. The general consensus: was more studies comparing drugs are needed, and this program would “save the government money”.

Some Food for Thought:

                Senator Kohl is introducing this to fight off any critics or changes to the Physician Payment Sunshine Act.

“The drug industry has challenged the Grassley-Kohl bill, claiming that the legislation will potentially restrict their ability to inform doctors about new drugs. The academic detailing legislation under consideration by Chairman Kohl and Senator Durbin addresses this charge.”

2) This bill is the equivalent of the government setting up pilot program to sell PC’s from 1984. It really has no chance of passage but it again gives Senator political cover to push along PPSA.

3) Policy makers and industry opponents are playing loose with the facts:

                Avorn using 25 year old data from NEJM as the main basis to support this issue with only the disclaimer “as published in the New England Journal of Medicine” Providing no disclosure of conflict of interest for Avorn (RXFACTS), presenting his case as if this was the Harvard position, referring to the doctors in his program receiving Harvard CME Credit.

                The former Eli Lilly sales representative from 8 years ago who fails to provide any evidence that the practices he discusses are prevalent or current.

                Kaiser and the state of Pennsylvania only discussing cost saving data with no data that proved that academic detailing enhanced optimal patient care.

               

4) This hearing exposed the fact that our industry is lacking friends, on committees.

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