Tuesday, January 17, 2012

Conflicts of Interest in the FDA

I just read the scariest sentence ever. "Recently, lawmakers have proposed loosening conflict of interest rules for FDA advisers to make it easier to find qualified experts." Wow! just wow!

Admittedly, I don't know anything about exactly what the current rules are and what the proposed changes are but I do think that with the history of rampant conflict of interest issues concerning pharmaceutical companies and FDA review boards, I think we all ought to be very very worried.

It's a pretty common practice for doctors to present their clinical opinions about drugs that are up for FDA approval, and to have been directly paid to do so by the pharma that's applying for approval. All kinds of people are paid to present evidence on behalf of the pharma's and their drugs. They would have us believe that this is standard practice and they are merely paid for their work but let's take the rose colored glasses off for the moment - are these 'experts' really going to take money from a pharma to go to the FDA and tell them they don't think the drug should be approved. And would the the pharma pay them if they knew that's what they were going to say. No. Everyone knows how this game is played.

So now the FDA is actually talking about loosening up their conflict of interest rules for their very own panels. We are not talking about approval boards where a number of outside parties come in and speak to the FDA on behalf of other interested parties, we are talking about internal FDA processes.

I read this very scary sentence in an article about an FDA review of the birth control that contain drospirenone, including Yaz and Yasmin. The FDA review board had determined that the drugs were safe and should remain the market. But, oh wait a minute, three of the 26 advisers to the board had financial ties to Bayer which makes Yaz and Yasmin. Another one of the advisers had connections to Barr Laboratories. All four of them said that the drugs benefits outweighed the risks. Are we surprised?

Yaz is a nightmare. It has been linked to serious side-effects and even to deaths in young women. Yes, every drug has its side effects but Yaz is proving to be much higher risk than other drugs. But this panel doesn't agree. a 4% higher risk of blood clots than any other birth control pill is not significant, in their opinion.

The pharmas already have much more influence over what happens at the FDA than they should, relaxing the conflict of interest rules will only make it worse. I shake my head in despair.

Thursday, January 12, 2012

Cookies for Justice - sweet!

This is just a short post to encourage everyone to buy girl guide cookies. In fact, buy a dozen, or several dozen. Why, because Girl Scouts are the latest target of the Christian right-wing in the states. Yes, we are in Canada,and we don't have girl scouts, we have girl guides, but they are affiliated with the World Association of Girl Guides and Girl Scouts, and we can still show solidarity by supporting those little girls and their delicious cookies.

What's all the hub-bub? In October of last year, a girl scout troupe in Colorado reversed an initial decision to bar a 7-year-old transgendered girl from participating in scouts. This is, of course, the thing to do. She is a girl and she wants to go to girl scouts. They don't do strip searches for anyone else, why should what this little girl's private bits look like have any bearing on her ability to participate? They said no initially, there was a huge uproar and they relented and said yes.

Well, the vocal minority has lost their shit over it and there have been obnoxious blog posts and videos decrying how dishonest and perverse girls scouts of America is. They are demanding a boycott of girl scout cookies. How stupid is that? Who in their right mind doesn't like girl scout cookies?

It's wrong and bigoted, and just plain stupid. So even though we are not in Colorado, we can do something in support (tasty, tasty support) by buying heaps of cookies.

Monday, January 9, 2012

Sex Addiction is a Myth - that's what I'm sayin'

Today I saw another article from Dr. David Ley about the myth of sex addiction. This is the second one I've seen in a couple of months. It's exciting to finally see some public counterpoint to this sex and porn addiction hysteria that's been all over the media for the past several years.

I've always been uncomfortable with the idea of sex addiction for a number of reasons. First, it concerns me when people are labelled sex addicts for simply having a lot of sex. There is absolutely no standard of what is a normal amount of sex or a normal amount of partners or normal things you should be doing with them. There is no objective way to say that this much sex or this many partners is unhealthy. So the decision to consider oneself or to call someone else a sex addict is totally arbitrary and is, unfortunately, usually based on someone's personal morals and values around sex. You could look at one person's behavior and consider it sick and dangerous whereas I might look at exactly the same person and think they have a healthy sex life. Who makes the decision and how?

I see this label thrown at a lot of people simply because they really love to watch porn and they do it a lot. That, in itself, is not a problem. What the real problem might be is society's trouble with porn and quickness to label it as perverse and unhealthy.

The second, and very much related, issue I have with the idea of porn addiction is when we label something natural, normal, and healthy as potentially addictive. Sex is a biological need, just as food and sleep are. When we start talking about these things as addictive, it's dangerous. The most common approach to dealing with addictions, the immediate response of most people, is to advocate complete abstinence. You can do that with cocaine or heroin or even alcohol because you don't need these things to survive. You can do it with sex too, but unless that is your natural inclination, it's not healthy. So where does that leave a sex addict? How are you supposed to live a healthy life and have healthy sexual relationships with yourself and others when you've come to believe that this natural part of you is bad for you? I think this messes people up in a big way.

The other problem I have with it is that is becomes an excuse. When people get caught doing sexual things that others don't approve of, often now they are quick to say that they are sex addicts. It's become commonplace for celebrities to do this - Tiger Woods would be a shining example. It's as if saying that you're a sex addict grants you absolution for all the things you've done that have hurt the people who love you. I'm sorry, but that's just not okay. It's not okay for any kind of addict and it's not okay for anyone who believes them self to be a sex addict. Even if you do have an addiction, you are still responsible for your actions. I do have a little more tolerance and understanding for people who are addicted to substances though because I understand that these are real, physical and psychological addictions that cause actual physical symptoms in those who suffer from them and these are incredibly hard to deal with and to think rationally through. In spite of what some 'scientists' would have you believe, sex addiction is not like that. We all make choices about our sexual behavior (not our thoughts and our desires, but our behavior) and we can choose to do something or not. Doing something that will hurt someone else is a choice, always, every time.

Dr. Ley points out that sex addiction is not acknowledged by the DSM as an actual mental illness and that "there is no evidence whatsoever that sex addiction is a valid psychiatric disorder. And there probably never will be."

Now people in my social work circles say that anything can be addictive and the way to judge that is whether the person is able to carry out regular daily life activities and if their work and home lives are disrupted because of the behavior. For example, if you have 6 beer every day after you get home from work but you make it to work every day and perform well and your home life is stable and healthy and you feel happy, then perhaps, in spite of drinking a lot, you don't have a drinking problem. In this same way, they would say that if you can't have a decent relationship and you miss work or get fired or miss out on other opportunities in life because all you want to do is watch porn and masturbate, then you are addicted to porn. That was a seductive idea to me at first - it's very social worky, isn't it? It's all up to the individual. And I do like that. Except what I would counter is that first of all, we can be pretty sure that even though you're living a good life, the 6 beers a day is probably not healthy for you so you may not be addicted but this behavior isn't good for you, where we cannot say that the porn and masturbation itself is actually unhealthy. Secondly, if you can't carry on a healthy work and family life because of your desire to watch porn and masturbate, I would venture to guess that the problem isn't the porn, it's other issues in your life that make doing this much more comfortable and perhaps comforting, than doing the other things in your life. And that is the issue, not the porn. You could say that about any addiction except that with substance addictions, the substance use itself is unhealthy and does cause physical and psychological problems all on its own. I don't believe that sexual activity does.

Dr. Ley's article in the telegraph is great. It's here:
if you want to give it a read. I am with him on this one. I think it's time to get over this idea and move to a place of acceptance about our sexual desires and behaviors. To me, this obsession with sex addiction has caused a lot more problems than it has ever solved.

Wednesday, January 4, 2012

Another Post from the land of 'What Were They Thinking?'

I got an e-mail from the lovely Koko the other day alerting me to a product she had stumbled across on the net. Here's is yet another example of why we really need to question and research before purchasing crap on-line.

This lovely gem, called 'Secret Ceres' supposedly 'tightens and heals the vagina while simultaneously stimulating the body’s own cleansing mechanism as well as the regeneration of skin tissue in a completely natural manner'. What is this amazing product and how does it work? It's a pumice stone for your woohoo. No, I am not making this up. This little thing is actually a small phallic-shaped piece of rough clay which causes 'exfoliation of the callus inside of the vagina'. Insert it for 2 to 5 minutes, two to three times a week and you'll have a tighter, more youthful, more beautiful vagina!

The people who make this thing obviously have no understanding, or perhaps no interest, of anatomy and physiology. I don't care what you've been doing, you don't have callouses in your vagina. You just don't. The tissues inside the vagina are not the same as the epidermis. It simply does not develop callouses. The epithelium in the vagina behaves very differently than our skin - it's made for absorbing and excreting fluids. The vagina is, essentially, a self-cleaning unit. It does not need to be scrubbed down like your rough cracked heels. In fact, I think the only way you might be able to get a callous in your vagina is by using this crazy thing.

This thing actually scares the hell out of me. I can't even fathom the kind of damage you could do by putting something rough and bumpy into your vagina and moving it around. That is going to abrade and irritate the vaginal tissue which will not only be uncomfortable and difficult to heal, it will also create tears into which bacteria and viruses and easily enter the bloodstream. This thing, in my opinion, is a raging STI is a black velvet pouch. It baffles me how people can sell stuff like this. Please don't buy this thing. If you want to have a youthful, beautiful vagina, use a gentle water-based or silicone lube when you put anything inside it, put only body-safe toys and devices inside it, and go see your doctor for a pap test regularly.