Wednesday, 4 May 2005

Princess Health and Celebrity Endorsements for Cancer Screening. Princessiccia

Princess Health and Celebrity Endorsements for Cancer Screening. Princessiccia

After a brief lull, things are getting interesting again....
Just out in the Journal of the National Cancer Institute is an article by the VA Outcomes Group from Vermont about celebrity endorsements of cancer screening. Briefly, the results of the study survey showed that about two-thirds of respondents recalled seeing particular celebrities endorsing cancer screening (e.g., men older than 50 were asked about seeing Norman Schwarzkpopf endorsing PSA screening for prostate cancer). Of those who recalled seeing a particular celebrity, about a quarter said that this exposure made them more likely to get screened.
The problems here are that decisions about cancer screening are sometimes complex, and it isn't always completely obvious that celebrity endorsed screening should be universal. In particular, there is quite a bit of doubt that PSA screening is generally beneficial. Yet celebrity endorsements "typically consist of one-sided messages that either assert that the celebrity's life was saved by a cancer screening test ... or suggest that the life of a loved one was lost due to failure to be screened."
The article concludes, "when it comes to communicating about complex decisions such as cancer screening, the goal should not be to persuade but to inform. Thus, we see no obvious role for celebrity endorsement of cancer screening."
But of course it is the poor primary care physician who will be stuck with the task of informing patients that the simplistic message they saw about screening on TV may not be the whole story. Caught in the cross-fire once again.
Princess Health and  Celebrity Endorsements for Cancer Screening.Princessiccia

Princess Health and Celebrity Endorsements for Cancer Screening.Princessiccia

After a brief lull, things are getting interesting again....
Just out in the Journal of the National Cancer Institute is an article by the VA Outcomes Group from Vermont about celebrity endorsements of cancer screening. Briefly, the results of the study survey showed that about two-thirds of respondents recalled seeing particular celebrities endorsing cancer screening (e.g., men older than 50 were asked about seeing Norman Schwarzkpopf endorsing PSA screening for prostate cancer). Of those who recalled seeing a particular celebrity, about a quarter said that this exposure made them more likely to get screened.
The problems here are that decisions about cancer screening are sometimes complex, and it isn't always completely obvious that celebrity endorsed screening should be universal. In particular, there is quite a bit of doubt that PSA screening is generally beneficial. Yet celebrity endorsements "typically consist of one-sided messages that either assert that the celebrity's life was saved by a cancer screening test ... or suggest that the life of a loved one was lost due to failure to be screened."
The article concludes, "when it comes to communicating about complex decisions such as cancer screening, the goal should not be to persuade but to inform. Thus, we see no obvious role for celebrity endorsement of cancer screening."
But of course it is the poor primary care physician who will be stuck with the task of informing patients that the simplistic message they saw about screening on TV may not be the whole story. Caught in the cross-fire once again.

Tuesday, 3 May 2005

Princess Health and Another Ghost Writing Update. Princessiccia

Princess Health and Another Ghost Writing Update. Princessiccia

Another update on ghost writing...

First, I have put below something by Ted Harding about how to find the report from the UK House of Commons committee that looked into ghost writing.

---------------------
To find the materials from the Health Select Committee, locate the relevant items here.
These are under "Reports":* 5 April 2005 Fourth Report- The Influence of the Pharmaceutical Industry
There are two parts to the Report:
HC 42-I The main Report
HC 42-II Appendices including transcripts of Oral evidence
This Report covers a lot more than the issue of "ghostwriting",which can be located in the section "Use of journals" on pages53(para 195)-55(para 201) of the main report HC 42-I, with references to evidence. It is clear that the Comittee deplores it, but apparently does not recommend specific regulatory action.
In the Introduction to Part II (HC 42-II), section "Promotion of Medicines to Professionals" (paras 4.14-4.22) there is reference to controls on what pharmaceutical companies may do in this area. Mostly this refers to sponsorship of meetings and people, andthe like, and does not explicitly refer to anything related to "ghostwriting". These controls come under Medicines (Advertising) Regulations1994 (regulation 21--inducements and hospitality), breach of which is a criminal offence. There is also reference to The MHRA Guidelines on Promotion and Advertising, which I have not consulted to see what they say about "ghostwriting."
Further evidence, some not printed in the Report, can be found here. Of these items, the "Supplementary memorandum by AstraZeneca(PI 33A)" (a follow-on to the PI 33 in the Report Pt II) has a section "Role of Professional Medical Writers" which sets out their asserted atttitude to "ghostwriting".
Under "Uncorrected Oral Evidence" see:
* 25 November 2004 The Influence of the Pharmaceutical Industry
* 2 December 2004 The Influence of the Pharmaceutical Industry
* 16 December 2004 The Influence of the Pharmaceutical Industry
* 13 January 2005 The Influence of the Pharmaceutical Industry
* 20 January 2005 The Influence of the Pharmaceutical Industry
* 7 February 2005 The Influence of the Pharmaceutical Industry
As can be seen from HC 42-I and HC 42-II, oral Evidence was infact taken from Thu 9 Sept 2004 onwards, but only the "raw" evidence from the 2004-5 session (7 Feb 2005 on) is available; there seems to be none on the 2003-4 website.
---------------------

Second, I found a 1997 report of an attempt to get a ghost written review article published, quite similar to that described by Dr. Fugh-Berman in the Journal of General Internal Medicine. The 1997 incident was documented in the journal Anesthesiology (Cullen DJ. Ghostwriting in scientific anesthesia journals. Anesthesiology 1997; 87: 195-196.) It can be found on the web by starting here.
In fact, the 1997 article includes earlier references (which I am trying to track down) which include yet another incident similar to the 1997 and current cases, but this time from 1993.

So, in summary, it seems that ghost writing is not a new problem, just one that has lurked below the radar for quite a while. This makes it all the more important to address it. Until we do, it will have a corrosive effect on our trust in the medical scientific literature.
Princess Health and  Another Ghost Writing Update.Princessiccia

Princess Health and Another Ghost Writing Update.Princessiccia

Another update on ghost writing...

First, I have put below something by Ted Harding about how to find the report from the UK House of Commons committee that looked into ghost writing.

---------------------
To find the materials from the Health Select Committee, locate the relevant items here.
These are under "Reports":* 5 April 2005 Fourth Report- The Influence of the Pharmaceutical Industry
There are two parts to the Report:
HC 42-I The main Report
HC 42-II Appendices including transcripts of Oral evidence
This Report covers a lot more than the issue of "ghostwriting",which can be located in the section "Use of journals" on pages53(para 195)-55(para 201) of the main report HC 42-I, with references to evidence. It is clear that the Comittee deplores it, but apparently does not recommend specific regulatory action.
In the Introduction to Part II (HC 42-II), section "Promotion of Medicines to Professionals" (paras 4.14-4.22) there is reference to controls on what pharmaceutical companies may do in this area. Mostly this refers to sponsorship of meetings and people, andthe like, and does not explicitly refer to anything related to "ghostwriting". These controls come under Medicines (Advertising) Regulations1994 (regulation 21--inducements and hospitality), breach of which is a criminal offence. There is also reference to The MHRA Guidelines on Promotion and Advertising, which I have not consulted to see what they say about "ghostwriting."
Further evidence, some not printed in the Report, can be found here. Of these items, the "Supplementary memorandum by AstraZeneca(PI 33A)" (a follow-on to the PI 33 in the Report Pt II) has a section "Role of Professional Medical Writers" which sets out their asserted atttitude to "ghostwriting".
Under "Uncorrected Oral Evidence" see:
* 25 November 2004 The Influence of the Pharmaceutical Industry
* 2 December 2004 The Influence of the Pharmaceutical Industry
* 16 December 2004 The Influence of the Pharmaceutical Industry
* 13 January 2005 The Influence of the Pharmaceutical Industry
* 20 January 2005 The Influence of the Pharmaceutical Industry
* 7 February 2005 The Influence of the Pharmaceutical Industry
As can be seen from HC 42-I and HC 42-II, oral Evidence was infact taken from Thu 9 Sept 2004 onwards, but only the "raw" evidence from the 2004-5 session (7 Feb 2005 on) is available; there seems to be none on the 2003-4 website.
---------------------

Second, I found a 1997 report of an attempt to get a ghost written review article published, quite similar to that described by Dr. Fugh-Berman in the Journal of General Internal Medicine. The 1997 incident was documented in the journal Anesthesiology (Cullen DJ. Ghostwriting in scientific anesthesia journals. Anesthesiology 1997; 87: 195-196.) It can be found on the web by starting here.
In fact, the 1997 article includes earlier references (which I am trying to track down) which include yet another incident similar to the 1997 and current cases, but this time from 1993.

So, in summary, it seems that ghost writing is not a new problem, just one that has lurked below the radar for quite a while. This makes it all the more important to address it. Until we do, it will have a corrosive effect on our trust in the medical scientific literature.

Friday, 29 April 2005

Princess Health and Lawmakers Seek Drug Safety Reform at FDA. Princessiccia

Princess Health and Lawmakers Seek Drug Safety Reform at FDA. Princessiccia

It's coming closer to the day when the practices of the pharma industry on postmarketing surveillance and advertising are going to be more tightly regulated:

Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency. The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.


The industry earned this oversight the really old-fashioned way: through muddled thinking and neglect (at best).

From a medical informatics perspective, I believe rigid adherence to what I call the "assembly line data management" approach of the data-processing deparment of yesteryear - lacking any real creativity and utilization of healthcare informatics research and insights - has contributed to industry harm. Such "1970's thinking" has helped cause the need for a government-mandated oversight committee. The effects of "business driving the science" only compounded this problem.

As I have written before, healthcare informatics specialists are rare as hen's teeth in pharma despite NIH-funded training programs at major universities and many other internally-funded programs funded at universities in the U.S. and abroad. (As a personal observation, it was literally stunning that the pharma industry found my background wanting in terms of doing anything involved in drug safety data management - and, in fact, in doing anything at all other than overseeing research libraries under control of Management Information Systems personnel who themselves lacked substantive scientific credentials. )

-- SS
Princess Health and  Lawmakers Seek Drug Safety Reform at FDA.Princessiccia

Princess Health and Lawmakers Seek Drug Safety Reform at FDA.Princessiccia

It's coming closer to the day when the practices of the pharma industry on postmarketing surveillance and advertising are going to be more tightly regulated:

Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency. The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.


The industry earned this oversight the really old-fashioned way: through muddled thinking and neglect (at best).

From a medical informatics perspective, I believe rigid adherence to what I call the "assembly line data management" approach of the data-processing deparment of yesteryear - lacking any real creativity and utilization of healthcare informatics research and insights - has contributed to industry harm. Such "1970's thinking" has helped cause the need for a government-mandated oversight committee. The effects of "business driving the science" only compounded this problem.

As I have written before, healthcare informatics specialists are rare as hen's teeth in pharma despite NIH-funded training programs at major universities and many other internally-funded programs funded at universities in the U.S. and abroad. (As a personal observation, it was literally stunning that the pharma industry found my background wanting in terms of doing anything involved in drug safety data management - and, in fact, in doing anything at all other than overseeing research libraries under control of Management Information Systems personnel who themselves lacked substantive scientific credentials. )

-- SS

Thursday, 28 April 2005

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit. Princessiccia

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit. Princessiccia

The Los Angeles Times reported today that the US Securities and Exchange Commission (SEC) has warned that it may sue Tenet Healthcare six former executives because of Tenet's former Medicare billing practices in place through early 2003. Tenet said it has been cooperating with the SEC investigation. The former executives include Tenet's former Chief Executive Officer (CEO) Jeffrey C. Barbakow, fomer Chief Operating Officer (COO) Thomas B. Mackey, former Chief Financial Officer (CFO) David L. Dennis, former General Counsel Christi R. Sulzbach, former Chief Accounting Officer Raymond L. Mathiesen, and former Senior Vice President of Government Programs Steve Dominguez. All left Tenet in 2002-2003. A racketeering suit was filed earlier this year against Tenet by the Florida Attorney General on this issue. A company spokesperson said "We will respond to hopefully demonstrate why an enforcement action is not necessary."
Of course, the outcome of this case is still in doubt, but it doesn't exactly inspire confidence in how this major hospital system was lead.