The FDA seized existing US supplies of Paxil and Avandamet, drugs manufactured by UK drug giant GlaxoSmithKline. Glaxo said they have temporarily halted distribution of the drug pending settlement of the matter, in which they are accused of "continued violations" of quality tests.
According to CNN, FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John Taylor, FDA Associate Commissioner for Regulatory Affairs.
We applaud the FDA for taking even a small amount of the killer drug Paxil off the market. However, we now we want to know the answer to the next question: is this really a tough, new and more perceptive FDA, or is it the same old whoring FDA, attacking a British competitor to their darling American manufacturer Eli Lilly, maker of the Paxil competitor Prozac?
Saturday, March 05, 2005
Friday, March 04, 2005
Paxil vs. Natural Remedies
Jenny Thompson at HSI came up with this one. You might like to subscribe to her great newsletter.
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The medical mainstream HATES this kind of thing.
In a recent trial that tested St. John's wort against the selective serotonin reuptake inhibitor (SSRI) paroxetine (better known by its U.S. brand name Paxil), St. John's wort produced better results and fewer adverse side effects.
Over a six-week study period, 122 patients with moderate to severe depression took a 900 mg St. John's wort extract daily, and 122 similar patients took 20 mg daily dose of Paxil. Results showed that about half the subjects in the St. John's wort group experienced relief from depression, while only about one-third of the Paxil subjects experienced relief.
As reported in the British Medical Journal (BMJ), about 170 adverse side effects occurred in the St. John's wort group, and nearly 270 side effects in the Paxil group. In both groups, stomach disorders were the most common complaint.
These results aren't a complete surprise. We've seen St. John's wort perform better with fewer side effects when pitted against pharmaceutical SSRIs in previous studies (although usually in subjects with light to moderate depression). Yet, what I found most interesting in this case were two comments about the study posted on the BMJ web site.
The first comment comes from Tim Watkins, the director of the Depression Alliance in the UK. He says he detects a hidden agenda in the study because the researchers (funded by a manufacturer of herbal remedies) chose Paxil instead of another SSRI. Paxil, he points out, has the worst reputation for side effects in this class of drugs. He says the researchers "must have known" that St. John's wort would produce fewer side effects than other SSRIs.
I can't agree that the researchers "must have known" how the side effects would stack up. These studies have a way of often producing surprise results. Just look at all those HRT studies that blew up in the researchers' faces.
And don't feel too sorry for poor beleaguered Paxil. GlaxoSmithKline, the maker of Paxil, reports that the drug brought in more than $2 billion in sales last year. In other words, there are a LOT of Paxil users out there. So in spite of the unfairness perceived by Mr. Watkins, the trial actually provides a service to any Paxil user who may be suffering from some of the more severe long-term side effects that have been associated with the drug.
The second BMJ comment comes from Jane Robertson, a reader in Australia. Jane is not a health professional, but she is a St. John's wort user. She writes that after spending 20 years in counseling to address chronic mild depression, she began using St. John's wort three years ago, and is now "leading a mentally healthy life without the agonized thinking I spent so long trying to sort out." She adds that her life has "been changed" by St. John's wort and is grateful that extracts of the herb are available over the counter.
'Nuff said. I will add, however, that St. John's wort should be taken with caution, especially by those who are also taking prescription drugs. St. John's wort has been shown to interfere with the effectiveness of some drugs. It is also critical that you not take yourself off of an SSRI without working with your doctor, especially if you are planning to substitute with St. John's wort or any other herbal or dietary supplement.
---
The medical mainstream HATES this kind of thing.
In a recent trial that tested St. John's wort against the selective serotonin reuptake inhibitor (SSRI) paroxetine (better known by its U.S. brand name Paxil), St. John's wort produced better results and fewer adverse side effects.
Over a six-week study period, 122 patients with moderate to severe depression took a 900 mg St. John's wort extract daily, and 122 similar patients took 20 mg daily dose of Paxil. Results showed that about half the subjects in the St. John's wort group experienced relief from depression, while only about one-third of the Paxil subjects experienced relief.
As reported in the British Medical Journal (BMJ), about 170 adverse side effects occurred in the St. John's wort group, and nearly 270 side effects in the Paxil group. In both groups, stomach disorders were the most common complaint.
These results aren't a complete surprise. We've seen St. John's wort perform better with fewer side effects when pitted against pharmaceutical SSRIs in previous studies (although usually in subjects with light to moderate depression). Yet, what I found most interesting in this case were two comments about the study posted on the BMJ web site.
The first comment comes from Tim Watkins, the director of the Depression Alliance in the UK. He says he detects a hidden agenda in the study because the researchers (funded by a manufacturer of herbal remedies) chose Paxil instead of another SSRI. Paxil, he points out, has the worst reputation for side effects in this class of drugs. He says the researchers "must have known" that St. John's wort would produce fewer side effects than other SSRIs.
I can't agree that the researchers "must have known" how the side effects would stack up. These studies have a way of often producing surprise results. Just look at all those HRT studies that blew up in the researchers' faces.
And don't feel too sorry for poor beleaguered Paxil. GlaxoSmithKline, the maker of Paxil, reports that the drug brought in more than $2 billion in sales last year. In other words, there are a LOT of Paxil users out there. So in spite of the unfairness perceived by Mr. Watkins, the trial actually provides a service to any Paxil user who may be suffering from some of the more severe long-term side effects that have been associated with the drug.
The second BMJ comment comes from Jane Robertson, a reader in Australia. Jane is not a health professional, but she is a St. John's wort user. She writes that after spending 20 years in counseling to address chronic mild depression, she began using St. John's wort three years ago, and is now "leading a mentally healthy life without the agonized thinking I spent so long trying to sort out." She adds that her life has "been changed" by St. John's wort and is grateful that extracts of the herb are available over the counter.
'Nuff said. I will add, however, that St. John's wort should be taken with caution, especially by those who are also taking prescription drugs. St. John's wort has been shown to interfere with the effectiveness of some drugs. It is also critical that you not take yourself off of an SSRI without working with your doctor, especially if you are planning to substitute with St. John's wort or any other herbal or dietary supplement.
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