Monday, 13 June 2005

Princess Health and MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising. Princessiccia

Princess Health and MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising. Princessiccia

Fellow health care blogger Robert Centor MD (of MedRants) published an op-ed in USA Today advocating that direct to consumer (DTC) advertisements for pharmaceuticals should be banned.
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?
Princess Health and  MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising.Princessiccia

Princess Health and MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising.Princessiccia

Fellow health care blogger Robert Centor MD (of MedRants) published an op-ed in USA Today advocating that direct to consumer (DTC) advertisements for pharmaceuticals should be banned.
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?

Saturday, 11 June 2005

Princess Health and How Johnson & Johnson Marketed Propulsid. Princessiccia

Princess Health and How Johnson & Johnson Marketed Propulsid. Princessiccia

The NY Times reported on the events leading up to Johnson & Johnson's withdrawal of Propulsid, based on documents made available by related lawsuits. Propulsid was withdrawn from the market after its use was related to serious cardiac rhythm disturbances.
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren�t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "
Princess Health and  How Johnson & Johnson Marketed Propulsid.Princessiccia

Princess Health and How Johnson & Johnson Marketed Propulsid.Princessiccia

The NY Times reported on the events leading up to Johnson & Johnson's withdrawal of Propulsid, based on documents made available by related lawsuits. Propulsid was withdrawn from the market after its use was related to serious cardiac rhythm disturbances.
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren�t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "

Friday, 10 June 2005

Princess Health and Government officials who "get it". Princessiccia

Princess Health and Government officials who "get it". Princessiccia

I heard Department of Health and Human Services Secretary Michael Leavitt speak at the AHRQ Annual Patient Safety and Health Information Technology conference this week. The linked article summarizes his plans for spearheading standardization on electronic medical records data.

It is with great pleasure that I can report this government official seems to know the issues, challenges and benefits of such an initiative quite well.

US moves to spur digital health records nationwide
By Lisa Richwine
Mon Jun 6, 5:11 PM ET

The U.S. government is taking steps to help spawn a nationwide network of electronic medical records that are easily accessible but protect patient privacy, Health and Human Services Secretary Michael Leavitt said on Monday.

A new advisory panel will make recommendations aimed at prodding the private sector to establish standards so medical records can be shared throughout the health-care system, Leavitt said.

"In order for health IT (information technology) to move forward, we have to have interoperable standards ... creating a system where information is digital, privacy protected and interchangeable," Leavitt said in an interview ... the new panel, announced by Leavitt at a health IT meeting in New York, will have 17 government and private sector members, plus Leavitt as chairman. The group will give recommendations on how to make health records compatible among varying computer systems while keeping patient information secure. The panel will exist for at least two years and possibly as long as five years ... President Bush has set a goal for most Americans to have electronic health records by 2014.

The last paragraph was particularly interesting:

Leavitt said the technology also would be a boost to the Food and Drug Administration's efforts to monitor drug side effects because reports from throughout the country could be gathered quickly for analysis.

Then there's this from the New York Times:

Drug Safety System Is Broken, a Top F.D.A. Official Says
By Gardiner Harris

WASHINGTON, June 8 - A top federal drug official told a medical advisory board on Wednesday that the nation's drug safety system had "pretty much broken down" and that there was room for "a lot of improvement" in the government's approach to uncovering dangers in drugs already on the market.

The official, Dr. Janet Woodcock, deputy commissioner of operations at the Food and Drug Administration, made her remarks before a committee of experts at the Institute of Medicine, who had been asked by the agency to suggest safety improvements after a year of well-publicized troubles, including the withdrawal of two big-selling painkillers.

... She said the drug agency had long known that it needed to improve systems for learning about problems with drugs on the market. One way to do that, she said, is to take advantage of electronic health records from managed-care organizations.

As I wrote here, I agree with these assessments. Unfortunately, based on my experiences in pharma (where my experience in EMR and views on its use for drug safety surveillance were quite completely ignored, or perhaps I should say discarded), I predict there will be significant initial opposition by pharma to use of data collected on adverse drug events from EMR's. It is not data from a RCT, after all, and will invariably cause major headaches after the rollout of new drugs.

-- SS