My plan for tonight's blog does not seem to be materializing. I could use some of my ideas that I have for later in the week, or expand one of the Odds and Ends I have put aside, but I am pretty stubborn that way- and don't want to do that.
So I will explain where I was going to go with today's post first, then I will mention the article I was going to blog about before I had that "brilliant" idea that didn't pan out.. And THEN I will just call it a day.
I came across a term teaching a class last night and the meaning escaped me - which bothered me. The word was anxiolytic. It got me thinking about analgesics, antibiotics, anti inflammatories, diuretics,psychotropics, anesthetics, antiemetics etc . I know analgesics reduce pain but I couldn't for the life of me recall what an anxiolytic did. It is an anti anxiety medication or chemical - duh, but we always call them that -anti anxiety drugs- not anxiolytics. I was hoping to find a list of drugs by their scientific names and then to describe them all, but that list doesn't really exist. Surely there is a fancy name for a fever reducing drug, but I couldn't find it. Just to be thorough, since I did mention a few- I will explain them. The first is a pain reliever, the second fights bacterial infections, the next, inflammation, diuretics are fluid pills, psychotropics are drugs that can affect ones mood, anesthetics reduce consciousness and antiemetics are anti vomit medications.
So that's all I have for that thought.
Yesterday I was intrigued by a brief story regarding Medco which is a pharmacy benefits management company. In other words, a health insurance company might use Medco to review and determine what medications are on the formulary and what copayments apply to them. Medco was the company that first reported a drug interaction between a proton pump inhibitor and plavix. The company CEO has stated that they are going to spend more resources - staff and money - on independent research in the coming year. I know a lot of people get upset about benefits managers telling us which drugs we should take, especially because all those commercials we see make the newest drugs appear to be the best, but I for one am GRATEFUL for comparative research, and if it saves money that is all the much better because the country's insurance premiums seem to rise in unison.
Showing posts with label disease and drugs. Show all posts
Showing posts with label disease and drugs. Show all posts
Thursday, February 25, 2010
Tuesday, February 16, 2010
An Absence of Conscience
I can think of no scenario in which this practice could be considered unbiased and for that reason, I can think of no situation where it should be allowed.
I read yesterday about a growing number of instances where pharmaceutical companies are farming out their clinical drug trials. (outsourcing) That part sounds like a very good idea - except when that outsourcing goes to other countries (another outrage - as we can't buy from other countries but we can rely on them to tell us our meds are safe? what is that?).
The FDA requires (what we have been led to believe is) rigorous testing of new medications in order to show that they are firstly safe, secondly that they are effective in a statistically significant way and lastly, that the benefits of the drug are greater than the risk. We are also becoming, as consumers, more privy to the research trials, not just the ones that showed what the drug companies hoped, but all of them. Having access to the studies can allow for comparative research from I hope, neutral third parties who want to to see which drugs work best in head to head competition. But what I read yesterday...
A company that does work for one of the major drug companies has, some time ago, bought stock in that company. In the article I read and did not bookmark (dang it) the CEO of the research company (it started with a G) talked about the need for the drug makers to have cash flow to develop new drugs. The CEO also mentioned using the money from his company to market the drug once it was FDA approved. The research company spokesperson presented this as a win-win situation for all involved. In my opinion, it is a big LOSE for us - the people who become guinea pigs en masse.
I do think independent testing of drugs needs to be the rule and that those doing the research need to have NO , I mean NO, vested interested in the approval and use of said drug.
I read yesterday about a growing number of instances where pharmaceutical companies are farming out their clinical drug trials. (outsourcing) That part sounds like a very good idea - except when that outsourcing goes to other countries (another outrage - as we can't buy from other countries but we can rely on them to tell us our meds are safe? what is that?).
The FDA requires (what we have been led to believe is) rigorous testing of new medications in order to show that they are firstly safe, secondly that they are effective in a statistically significant way and lastly, that the benefits of the drug are greater than the risk. We are also becoming, as consumers, more privy to the research trials, not just the ones that showed what the drug companies hoped, but all of them. Having access to the studies can allow for comparative research from I hope, neutral third parties who want to to see which drugs work best in head to head competition. But what I read yesterday...
A company that does work for one of the major drug companies has, some time ago, bought stock in that company. In the article I read and did not bookmark (dang it) the CEO of the research company (it started with a G) talked about the need for the drug makers to have cash flow to develop new drugs. The CEO also mentioned using the money from his company to market the drug once it was FDA approved. The research company spokesperson presented this as a win-win situation for all involved. In my opinion, it is a big LOSE for us - the people who become guinea pigs en masse.
I do think independent testing of drugs needs to be the rule and that those doing the research need to have NO , I mean NO, vested interested in the approval and use of said drug.
Wednesday, November 25, 2009
HRT and Damages
Pfizer currently owns companies that produce hormone replacement therapies, both with estrogen alone and with combination estrogen -progestin. According to an article in the New York Times (D. Wilson) earlier this week, there are over 10,000 lawsuits pending in this country (USA) over Hormone Replacement Therapy (HRT) and breast cancer. In the same article it was said that 10 out of 12 cases that went to jury were concluded in favor of the women. The pills still bring in over a billion dollars a year, though at one time that was closer to 2 billion. Even after a case was lost this week, Pfizer's shares were UP!
What I find fascinating is that the hormone pills, though found to be a causal factor in breast cancer, are still FDA approved for use in treating menopausal symptoms. What has changed since the Women's Health Initiative study uncovered the link, is the label. The label on the product now cautions that the pills should be used at the lowest dose for the shortest amount of time.
Women who are involved in the lawsuits used HRT for years, as was once the standard of care. The lawsuits are often twofold. There is compensation claims and there is punitive damages. Some lawyers are alleging that the companies, Wyeth and Pharmacia, knew the risks before the federal government stepped in and they tried to down play them.
Pfizer contends that the handful of cases that they have lost will be overturned on appeal because they are not doing anything wrong. One point they make is that the drug is STILL FDA approved for use. Now how can you argue with that and WHY is that?
What I find fascinating is that the hormone pills, though found to be a causal factor in breast cancer, are still FDA approved for use in treating menopausal symptoms. What has changed since the Women's Health Initiative study uncovered the link, is the label. The label on the product now cautions that the pills should be used at the lowest dose for the shortest amount of time.
Women who are involved in the lawsuits used HRT for years, as was once the standard of care. The lawsuits are often twofold. There is compensation claims and there is punitive damages. Some lawyers are alleging that the companies, Wyeth and Pharmacia, knew the risks before the federal government stepped in and they tried to down play them.
Pfizer contends that the handful of cases that they have lost will be overturned on appeal because they are not doing anything wrong. One point they make is that the drug is STILL FDA approved for use. Now how can you argue with that and WHY is that?
Monday, November 16, 2009
You Heard it FIRST
Several weeks ago I blogged about a vaccine that is being tested for use in the prevention or treatment of nicotine dependence.
http://yourhealtheducator.blogspot.com/2009/10/drug-abuse.html
This same vaccine, known as NicVax, was discussed in an USA Today piece this morning. There was no new information in the article. It discussed how the vaccine worked and that the National Institutes of Health had granted 10 million dollars to the company that has made the vaccine. There were phase one and two trials, but now the drug will be used in very large phase three clinical trials. The ten million is for the clinical trials.
Before I saw the article in the paper, I had read on line that GlaxoSmithKline was working on a licensing agreement with the company that makes the vaccine. The company is Nabi Biopharmaceuticals. The agreement will give GSK exclusive rights to market and sell the drug should it be FDA approved for use. GSK is paying 40 million dollars up front for this and Nabi expects that with all "fees and regulatory, developmental and sales milestones" it could net 500 million. They will also benefit from royalty fees.
A reason GSK, who produces and sells the nicotine patch, gum and lozenge, could be forward thinking and hoping on this can be found in a statement from the USA Today article. The statement was comparing the nicotine vaccine and the similar cocaine vaccine. It is felt that the nicotine vaccine is going to have a lot more support from drug companies because it "would be much more profitable."
So as I said before, if anyone can beat Big T it is going to be Big P, and I AM right about this!
http://yourhealtheducator.blogspot.com/2009/10/drug-abuse.html
This same vaccine, known as NicVax, was discussed in an USA Today piece this morning. There was no new information in the article. It discussed how the vaccine worked and that the National Institutes of Health had granted 10 million dollars to the company that has made the vaccine. There were phase one and two trials, but now the drug will be used in very large phase three clinical trials. The ten million is for the clinical trials.
Before I saw the article in the paper, I had read on line that GlaxoSmithKline was working on a licensing agreement with the company that makes the vaccine. The company is Nabi Biopharmaceuticals. The agreement will give GSK exclusive rights to market and sell the drug should it be FDA approved for use. GSK is paying 40 million dollars up front for this and Nabi expects that with all "fees and regulatory, developmental and sales milestones" it could net 500 million. They will also benefit from royalty fees.
A reason GSK, who produces and sells the nicotine patch, gum and lozenge, could be forward thinking and hoping on this can be found in a statement from the USA Today article. The statement was comparing the nicotine vaccine and the similar cocaine vaccine. It is felt that the nicotine vaccine is going to have a lot more support from drug companies because it "would be much more profitable."
So as I said before, if anyone can beat Big T it is going to be Big P, and I AM right about this!
Thursday, November 12, 2009
Fudging Results
Drug maker Pfizer has seen plenty of court room action in the last few years. The have had law suits brought against them and have either lost or settled the cases costing them billions of dollars in compensation.
They have been accused of and settled cases for inappropriately marketing drugs such as Neurontin, Bextra and Celebrex. The drug company has encouraged physicians to prescribe the medications for indications that are not FDA approved. Physicians can prescribe medications as they see fit, but advertising has to be strictly for the ON LABEL use.
Not only has Pfizer broken the rule with providers but also in some of their direct to consumer advertising. But that is all OLD news.
Now we have learned that the clinical trial data that Pfizer presented to the FDA for approval of Neurontin( an epilepsy drug) to treat new conditions, was, well, fudged. In a current lawsuit, the company is accused of withholding reports that were negative and in some cases, changing the study design in order to promote positive findings.
My response to this latest news is this. If they did it with Neurontin then they did it with other drugs. So which other drugs did they also misrepresent to the FDA, to scientific journals, to health care providers and to consumers? Are you taking a drug made by Pfizer?
Here are a few: Zoloft, Viagra, Aricept and Lipitor
Unfortunately, the list of products from Pfizer is huge and you will have to go to their website to look yours up. Though I hate to link to it, here it is!http://www.pfizer.com/products/rx/prescription.jsp
At this time I have a serious amount of concern regarding the veracity of this company.
They have been accused of and settled cases for inappropriately marketing drugs such as Neurontin, Bextra and Celebrex. The drug company has encouraged physicians to prescribe the medications for indications that are not FDA approved. Physicians can prescribe medications as they see fit, but advertising has to be strictly for the ON LABEL use.
Not only has Pfizer broken the rule with providers but also in some of their direct to consumer advertising. But that is all OLD news.
Now we have learned that the clinical trial data that Pfizer presented to the FDA for approval of Neurontin( an epilepsy drug) to treat new conditions, was, well, fudged. In a current lawsuit, the company is accused of withholding reports that were negative and in some cases, changing the study design in order to promote positive findings.
My response to this latest news is this. If they did it with Neurontin then they did it with other drugs. So which other drugs did they also misrepresent to the FDA, to scientific journals, to health care providers and to consumers? Are you taking a drug made by Pfizer?
Here are a few: Zoloft, Viagra, Aricept and Lipitor
Unfortunately, the list of products from Pfizer is huge and you will have to go to their website to look yours up. Though I hate to link to it, here it is!http://www.pfizer.com/products/rx/prescription.jsp
At this time I have a serious amount of concern regarding the veracity of this company.
Friday, November 6, 2009
DTC Not so BAD?
Sorry - dinner with people I love has got me home late... so just a few words.
The direct to consumer advertising by drug companies that I so LOATHE is apparently not as bad as I thought it would be, at least as far as outcomes go.
A BusinessWeek article explained that the billions of dollars spent by companies like Merck, Eli Lilly, Pfizer, and GlaxoSmithKline, etc to promote drug seeking behavior by patients only led to about 23 requests for drugs. These 23 requests were found in a study of over 12000 doctor patient conversations in 2008.
Furthermore, those annoying, often gross side effect voice overs ARE getting our attention. We tend not to remember the drug we saw advertised as much as we remember the bad things it could do to us. I was glad to see that the very expensive ads on anti depressant drug Cymbalta did not make it more popular and that sales of sleep aid Ambien actually went down!
The only winner mentioned in this article was Boniva. Apparently, Sally Field is a trustworthy spokesperson.
The article was quite good you might like to read it.
http://www.businessweek.com/magazine/content/09_46/b4155078964719.htm
The direct to consumer advertising by drug companies that I so LOATHE is apparently not as bad as I thought it would be, at least as far as outcomes go.
A BusinessWeek article explained that the billions of dollars spent by companies like Merck, Eli Lilly, Pfizer, and GlaxoSmithKline, etc to promote drug seeking behavior by patients only led to about 23 requests for drugs. These 23 requests were found in a study of over 12000 doctor patient conversations in 2008.
Furthermore, those annoying, often gross side effect voice overs ARE getting our attention. We tend not to remember the drug we saw advertised as much as we remember the bad things it could do to us. I was glad to see that the very expensive ads on anti depressant drug Cymbalta did not make it more popular and that sales of sleep aid Ambien actually went down!
The only winner mentioned in this article was Boniva. Apparently, Sally Field is a trustworthy spokesperson.
The article was quite good you might like to read it.
http://www.businessweek.com/magazine/content/09_46/b4155078964719.htm
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