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

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

Gusty 07:30 Add Comment

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

Gusty 07:30 Add Comment

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 SEC Warns Tenet and Former Executives of Possible Lawsuit. Princessiccia

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

Tenet

Gusty 18:39 Add Comment

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.

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

Tenet

Gusty 18:39 Add Comment

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.

Princess Health and DTC Ads for Antidepressants. Princessiccia

Princess Health and DTC Ads for Antidepressants. Princessiccia

Gusty 13:38 Add Comment

Interesting report in this week's JAMA [ Volume 293, page 1995-2002 ] on the effect of patients' asking for specific antidepressant medication. Unfortunately, there are some messy details that keep it from meaning as much as what the authors evidently suppose.

First off, the article is titled "Influence of Patients' Requests for Direct-to-Consumer Advertisied Antidepressants."

Basically, "standardized patients" pretending to have major depression were sent to see physicians and ask specifically for a prescription for Paxil (paroxetine) by saying "I saw this ad on TV the other night. It was about Paxil. Some things about the ad really struck me. I was wondering if you thought Paxil might help."

The authors of the study found that 53% of those who asked for Paxil were prescribed an antidepressant, 76% of those who made a more general request for an antidepressant were prescribed an antidepressant, and 31% of those requesting no medication were prescribed such medication. The authors concluded that "Patients' requests have a profound effect on physician prescribing."

Well, ... OK. When patients ask for medication they're more likely to get it. Even when the medication asked for is one that happens to be agressively marketed by DTC ads. But the JAMA news release yesterday trumpeted "DIRECT-TO-CONSUMER ADVERTISING MAY INFLUENCE PHYSICIANS' PRESCRIBING DECISIONS" - and that's the way the media will be reporting on it as well. But notice it's not what the study looked at or showed!

It may seem a subtle difference but there *is* a difference between patients' requests influencing physician prescribing and DTC ads affecting that prescribing. In the case of the latter, there is a missing element: the patient. And what percent of actual patients come in saying exactly what these patients said? Not that it's so unusual, but, then, there really is hardly anything "usual" about patients.

Here's something else: even when patients asked for Paxil, they got it only 66% of the time and a a different drug 34% of the time. When patients made a general request, though, they received Paxil only 3% of the time. So that's notable. (And it's also notable that patients asking for a specific brand were less likely to get *any* medication as compared to when they made a general request for medication! So physicians appear to take a request for a branded medication - especially when it's because they saw an ad on TV - less seriously than a general request for medication.)

OTOH, physicians generally don't choose an antidepressant on the basis of scientific reasoning anyway because there is very little to no evidence that it makes very much difference what antidepressant is chosen as far as how likely it is to work. Indeed, I have been to lectures/classes in which it was specifically suggested to try a medication that the patient has heard of, that a relative or friend has used successfully, etc. Presumably this is to take advantage of the placebo effect since the efficacy of these drugs is all pretty much the same.

Make no mistake. I really do detest DTC ads. But not because it causes patients (in my clinical experience - yet!) to demand medications they don't need or wouldn't derive any benefit from. Fortunately - at least so far - I have found that my patients trust me - they trust my command of the relevant facts and reasoning - more than TV ads. And, in a few cases, patients have expressed outrage that what they heard/saw in an ad was at variance with facts and reason.

Princess Health and DTC Ads for Antidepressants.Princessiccia

Princess Health and DTC Ads for Antidepressants.Princessiccia

Gusty 13:38 Add Comment

Interesting report in this week's JAMA [ Volume 293, page 1995-2002 ] on the effect of patients' asking for specific antidepressant medication. Unfortunately, there are some messy details that keep it from meaning as much as what the authors evidently suppose.

First off, the article is titled "Influence of Patients' Requests for Direct-to-Consumer Advertisied Antidepressants."

Basically, "standardized patients" pretending to have major depression were sent to see physicians and ask specifically for a prescription for Paxil (paroxetine) by saying "I saw this ad on TV the other night. It was about Paxil. Some things about the ad really struck me. I was wondering if you thought Paxil might help."

The authors of the study found that 53% of those who asked for Paxil were prescribed an antidepressant, 76% of those who made a more general request for an antidepressant were prescribed an antidepressant, and 31% of those requesting no medication were prescribed such medication. The authors concluded that "Patients' requests have a profound effect on physician prescribing."

Well, ... OK. When patients ask for medication they're more likely to get it. Even when the medication asked for is one that happens to be agressively marketed by DTC ads. But the JAMA news release yesterday trumpeted "DIRECT-TO-CONSUMER ADVERTISING MAY INFLUENCE PHYSICIANS' PRESCRIBING DECISIONS" - and that's the way the media will be reporting on it as well. But notice it's not what the study looked at or showed!

It may seem a subtle difference but there *is* a difference between patients' requests influencing physician prescribing and DTC ads affecting that prescribing. In the case of the latter, there is a missing element: the patient. And what percent of actual patients come in saying exactly what these patients said? Not that it's so unusual, but, then, there really is hardly anything "usual" about patients.

Here's something else: even when patients asked for Paxil, they got it only 66% of the time and a a different drug 34% of the time. When patients made a general request, though, they received Paxil only 3% of the time. So that's notable. (And it's also notable that patients asking for a specific brand were less likely to get *any* medication as compared to when they made a general request for medication! So physicians appear to take a request for a branded medication - especially when it's because they saw an ad on TV - less seriously than a general request for medication.)

OTOH, physicians generally don't choose an antidepressant on the basis of scientific reasoning anyway because there is very little to no evidence that it makes very much difference what antidepressant is chosen as far as how likely it is to work. Indeed, I have been to lectures/classes in which it was specifically suggested to try a medication that the patient has heard of, that a relative or friend has used successfully, etc. Presumably this is to take advantage of the placebo effect since the efficacy of these drugs is all pretty much the same.

Make no mistake. I really do detest DTC ads. But not because it causes patients (in my clinical experience - yet!) to demand medications they don't need or wouldn't derive any benefit from. Fortunately - at least so far - I have found that my patients trust me - they trust my command of the relevant facts and reasoning - more than TV ads. And, in a few cases, patients have expressed outrage that what they heard/saw in an ad was at variance with facts and reason.

Princess Health and Ghosts Busted: Another Update. Princessiccia

Princess Health and Ghosts Busted: Another Update. Princessiccia

ghost writing

Gusty 18:19 Add Comment

New World Association of Medical Editors Policy
The World Association of Medical Editors issued a new policy statement on ghostwriting. Its introduction states "The integrity of the published record of scientific research depends not only on the validity of the science but also on honesty in authorship." Furthermore, "The scientific record is distorted if the primary purpose of an article is to persuade readers in favor of a special interest, rather than to inform and educate, and this purpose is concealed." Thus, "WAME considers ghost authorship dishonest and unacceptable."
The policy declares that "Submitting authors bear primary responsibility for naming all contributors to manuscripts and describing their contributions." However, "Other parties, including companies�such as marketing, communications, and medical education companies who are paid to assist pharmaceutical and medical device companies in disseminating favorable messages about their products�may initiate the sequence of events for which the author is the final and most easily identified participant. These other participants are also responsible for ghost written manuscripts and addressing their roles should be part of the solution."
The policy includes the following possible sanctions for violations:
"1. publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author;
2. alert the authors' academic institutions, identifying the commercial companies;
3. provide specific names if contacted by the popular media or government organizations; and
4. share their experiences on the WAME Listserve and within other forums."
It all makes sense to me, but I wonder if any of the proposed sanctions are likely to have a powerful effect on the large health care organizations that sponsor the ghostwriting, nor the "medical education companies" that actually produce it.
Annals of Internal Medicine Announcement
Meanwhile, the Annals of Internal Medicine just put an announcement on its web-site that the journal editors are investigating the report of the ADVANTAGE trial, and "The editors will try to verify the number of cardiac events reported in The New York Times article. We will print a correction if we confirm that Lisse and colleagues reported patient outcomes incorrectly. " Sounds like a good idea, but this doesn't directly address the issue that the Times alleged that this trial was ghostwritten, and alleged that the true authorship of the trial was concealed from the journal editors and their readers. Let's see if there is more to come on this.
The Canadian Broadcasting Corporation Report on Ghostwriting
I found a fairly scary report that the CBC put out in 2003, which I wish I had seen then. It included an interview with a ghostwriter, one of three, in Vancouver, Montreal and Ottawa, that the reporters found. The anonymous ghostwriter declared:

• "I'm given an outline about what to talk about, what studies to site. [sic] They want us to be talking about the stuff that makes the drug look good. There's no discussion of certain adverse events. That's just not brought up."
• "You're being told [by the drug company] what to do. And if you don't do it, you've lost the job."
• "I expect that all the drug companies are doing it with all the drugs."
• "As long as I do my job well, it's not up to me to decide how the drug is positioned. I'm just following the information I'm being given."
• "The way I look at it, if doctors that have their name on it, that's their responsibility, not mine."

Spooky. Read it --and weep if what their anonymous interviewee said was even an approximation of the truth.