Dangerous Prescriptions- Frontline Program

In this Frontline Program, they are investigating our drug safety system. This program is from 2003 and years before the scandals with Vioxx, Celebrex, Avandia, and Paxil; nevertheless, the basic information and analysis of the problems in drug safety are still relevant. -Duncan



In "Dangerous Prescription," FRONTLINE® investigates the integrity of America's drug safety system. Through interviews with current and former FDA officials, critics, a pharmaceutical industry representative, and consumers, the one-hour documentary examines the FDA's handling of several drugs that were approved but later were pulled from the market after causing injuries and even deaths. The program also examines the role that drug companies play in the approval and monitoring of prescription drugs, and questions whether the FDA's current system is adequate for protecting the public.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/synopsis.html

http://snipurl.com/35zh9

Drugs and Kids- Frontline Program

In our rushed "let's solve this problem now" culture, more and more children are being given a mental or biochemical disease label and put on drugs designed and tested only on adults. The Frontline TV program linked here takes you to a 2001 analysis with a current (2008) update. This is a serious issue for all involved the kids, the parents, the schools, the culture. -Duncan



In recent years, there's been a dramatic increase in the number of children being diagnosed with serious psychiatric disorders and prescribed medications that are just beginning to be tested in children. The drugs can cause serious side effects, and virtually nothing is known about their long-term impact. "It's really to some extent an experiment, trying medications in these children of this age," child psychiatrist Dr. Patrick Bacon tells FRONTLINE. "It's a gamble. And I tell parents there's no way to know what's going to work." (more »)

In Case You Are Wondering about the Money

Please take a look at the last column which displays % of growth if you want a snapshot of the action in the pharmaceutical field.

Objective Medical Information??

So how many times have you gone to Medscape for medical information thinking that it was objective medical science. This excerpt below is an eye opener for those of us who keep the image of the public medical servant who always has the best interest of the patient in mind. The excerpt is from the Carlat Psychiatry Blog and a link to the full post is given below. -Duncan




Medscape is a medical education communication company entirely dependent on drug company advertising and CME funding for its existence. Many doctors have noticed recently that the company has dropped even the pretense of objectivity. Yesterday, I received a letter from Medscape in my office; inside was a brochure from Forest Laboratories advertising Lexapro, and nothing else. It was creepy, like Invasion of the Body Snatchers.

If you want to judge for yourself whether Medscape is capable of producing unbiased CME, go to their main CME page. You'll find dozens of CME articles, almost all of which are sponsored by different companies.

Here's one that can serve as a poster child for all that is wrong with industry-funded CME. Entitled "Managing Schizophrenia in a Patient With Alcohol Abuse and Hepatic Impairment", it is sponsored by Janssen, maker of Invega, a "new" antipsychotic which is simply the active metabolite of their now off-patent drug, Risperidone. As I've written here in The Carlat Psychiatry Report, Invega is simply a patent extender, with no real benefit other than the fact that it is not metabolized in the liver, and therefore is easier to dose in patients with hepatic impairment. In the grand tradition of promotional CME, Janssen commissioned Medscape to come up with a case-based program focussing on the single clinical situation in which Invega has an advantage.

http://carlatpsychiatry.blogspot.com/2008/06/medscapes-cme-corruption.html
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Putting Lipstick on a Pig

Here's another tidbit from Jim Edwards' NRx blog. The background is that many folks taking antidepressants are not enjoying much of a sex life these days so somebody decided that they would add some viagra to the mix for women. Now it is interesting that Pfizer says it is not going to apply to the FDA for permission to sell viagra to women on antidepressants. I guess they decided to fund the viagra for orgasm study out of the kindness of their scientific hearts.

It some ways this is a small story but one of those stories which highlights many of the most pressing issues in pharmaland: research design, pharma funding for research, stretching of the conclusions of the study etc. - Duncan


What's Wrong with That 'Viagra for Women' Study in JAMA?

Plenty.

The media has gone bonkers for this study which purports to show that women with sexual dysfunction brought on by anti-depressant use can get their orgasms back by taking Pfizer's Viagra. Google News had upwards of 476 stories on the study at the time of writing.

(NRx highlighted the Great Orgasm Robbery a couple of days ago. Summary: Anti-depressants rob you of your sex life, subjecting you to dystopian side effects such as the "pleasureless orgasm.")

But the study has problems, bears many of the hallmarks of garbage science, and raises serious questions about why JAMA would publish it.

Among the issues:

+ There were only 98 women in the trial. Forty nine of them were on the placebo and 49 were on Viagra.

+ Only 39 on Viagra actually completed the study.

+ Only 72% of those women reported improvement.

+ Which means that only 28 actual women reported improvement.

So that's it: 28 depressed women have an orgasm and the media goes crazy.

(The good news? At least nobody got cancer.)

The difficulties with the study don't end there.

Pfizer, the maker of Viagra, funded the study. And the doc who carried it out has taken Pfizer money before.

All the women are taking two drugs, an antidepressant plus Viagra, making it difficult to presume whose symptoms were being caused by what.

To qualify, their depression had to be in "remission" (meaning they were the type of patients who were already responding nicely to drugs, treatment, or were getting better on their own).

And the headline stat — that 72% of women taking happy pills plus Viagra get their orgasms back — masks some very odd data lower down in the results tables.

Check out the results in the study that are not about orgasms. "Arousal" got a P value of .81. "Sexual arousal" got .61. "Lubrication" got .64. "Sexual drive" got .40.

If one assumes the .01 value for orgasm was significant, then these other results suggest that although the women got their orgasms back, they didn't get back all the other stuff that goes along with them.

In other words, the one thing that makes this study interesting is that it may have provided hard proof of the reality of the pleasureless orgasm phenomenon.

And can we just remind ourselves of the fact that the reason these women are sexually dysfunctional is because they're taking the kind of drugs — such as Zoloft — that are made by Pfizer, in the first place?

http://jimedwardsnrx.wordpress.com/

http://snipurl.com/34vrr

Medical waste estimates.Unbelievable even if only half true!

PricewaterhouseCoopers is a Big Four auditor, alongside KPMG, Ernst & Young and Deloitte Touche Tohmatsu. In other words, PWC are major bean counters(accountants), not exactly folks to make radical statements.

Yet they estimate that more than half of all healthcare expenditures are wasteful. And that "more than half" is a whole lot of money: 1.2 Trillion dollars.

This is so big that it is easy to just glance over a figure like that without it making an impact but for example, less than 1/4 that amount could renovate all of the water infrastructures in the entire US of A.

So where is the wasteful spending going:

1. unnecessary tests and procedures.

2. inefficient administration

3. treatment of diseases better treated through lifestyle modifications, i.e. weight control, stop smoking, better nutrition, drug and alcohol programs.



Here are some excerpts from the PriceWaterhouseCooper site: You can download the complete report if you want all the nittygritty -Duncan

As part of its preparation for the 180° Health Forum, PricewaterhouseCoopers' Health Research Institute (HRI) interviewed more than 20 participants, reviewed more than 35 studies about waste and inefficiency in healthcare and surveyed 1,000 consumers to understand the public's perception of waste and inefficiency in the system. From that research came The price of excess:

Identifying waste in healthcare spending.

Key Findings

Our research found that wasteful spending in the health system has been calculated at up to $1.2 trillion of the $2.2 trillion spent in the United States, more than half of all health spending. Defensive medicine, such as redundant, inappropriate or unnecessary tests and procedures, was identified as the biggest area of excess, followed by inefficient healthcare administration and the cost of care necessitated by conditions such as obesity, which can be considered preventable by lifestyle changes. PricewaterhouseCoopers' paper classified health system inefficiencies into three "wastebaskets" that are driving up costs:

* Behavioral where individual behaviors are shown to lead to health problems, and have potential opportunities for earlier, non-medical interventions.
* Clinical where medical care itself is considered inappropriate, entailing overuse, misuse or under-use of particular interventions, missed opportunities for earlier interventions, and overt errors leading to quality problems for the patient, plus cost and rework.
* Operational where administrative or other business processes appear to add costs without creating value.

When added together, the opportunities for eliminating wasteful spending add up to as much as $1.2 trillion. The impact of issues such as non-adherence to medical advice and prescriptions, alcohol abuse, smoking and obesity are exponential, and fall into all three baskets.

link to PWC
http://tinyurl.com/64lcfg

Gives a Whole New Meaning to "Sex and Drugs"

Here's a story from Jim Edwards' blog NRx. He gives some facts and figures on how SSRI's are having a devastating effect on people's sex lives. We have been going through all these years thinking about how sex and drugs were connected in a positive correlation(more drugs, more sex) when all of a sudden they have an negative correlation(more drugs, less sex).

Not to worry though. Another story of the day is about how a research study shows that if women taking Paxil are experiencing a rotten sex life, the solution is to take Viagra. A wonderful deal for Pfizer which just happens to manufacture both drugs. Ain't chemistry wonderful!!! -Duncan

Worst Side Effect Ever: The 'Pleasureless Orgasm'
July 21, 2008


File this one under "Why isn't this on the front page?!" It's a natural audience-grabber that actually has some proper science behind it:

SSRI antidepressants — such as Paxil, Lexapro, Zoloft, Luvox and Prozac — have rates of "decreased libido, delayed orgasm, anorgasmia, erectile dysfunction, and difficulties with arousal, of between 36 and 70%," according to a new study.

First reported on the excellent (but badly named) psychiatry blog "Clinical Psychology and Psychiatry: A Closer Look," the study is a comprehensive review of sexual side effects triggered by selective serotonin re-uptake inhibitors. (That's happy pills, for us lay-folk.)

One of the worst side effects, seemingly designed by the devil himself, is the "pleasureless orgasm." The condition goes hand in hand with "genital anaesthesia" (meaning "can't feel anything," presumably).

Let's do a little math: According to Scientific American, close to 10% of Americans are on antidepressants. Let's make it easy and say that's 30 million of 300 million yanks. Of those, possibly 23 million are walking around in a state of sexual frustration. And they have partners — so that's somewhere in the neighborhood of a possible 46 million of us who are inexplicably tetchy and bad tempered on most days. (Yes, I know that some of them will be dating each other — but you can see my point.)

http://jimedwardsnrx.wordpress.com/2008/07/21/worst-side-effect-ever-the-pleasureless-orgasm/

http://snipurl.com/33a84