FDA Considers Easing Curbs on Drug Makers

The Washington Post ran an article Saturday about research on off-label uses for prescription drugs. Of all the medications that I take, only one is used for its intended purpose - my thyroid medication. I had to have my doctor work with my insurance company so I could have one of those medications covered (out of pocket, it's about $300 for a two month supply; with insurance, it's $57). Off-label uses of medications are, as you can imagine, important to me.

So, I think I'm in favor of drug companies giving doctors information on research they've done regarding off label uses. There are many medications out there, and doctors may not realize that they can help a patient if they just had more knowledge about off-label usage.

Here's the link to the article:

http://www.washingtonpost.com/wp-dyn/content/article/2007/11/30/AR2007113002300.html?wpisrc=newsletter

And here's the text of the article (I don't know how to do cuts like I do on LJ):

FDA Considers Easing Curbs on Drug Makers
Research on Off-Label Use Could Be Sent to Doctors

By Christopher LeeWashington Post Staff WriterSaturday, December 1, 2007; A04

The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
Under a draft "guidance" prepared by the FDA, drug and medical device manufacturers could distribute unabridged reprints of peer-reviewed research from reputable medical journals as long as the articles were not written, edited or otherwise "significantly influenced" by the manufacturers or people with financial ties to them. No other promotional materials could be attached to the reprints, which would have to be labeled as describing uses for the products that have not been approved by the FDA.

The proposal would be a break with the FDA's prohibition on the marketing of drugs and medical devices for unapproved purposes, which dates to 1938. It is legal for doctors to prescribe approved drugs for off-label uses, however, and the practice is common for some types of drugs.

In 1997, Congress created a temporary exception allowing companies to distribute reprints so long as they submitted them to the FDA for advance review and had formally asked the FDA to approve the new use. That exception expired in 2006. In recent years, the marketing restrictions have been the subject of legal challenges on free speech grounds.

Rep. Henry A. Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, said creating a new path to promote off-label uses could improperly influence doctors' prescribing habits. In a letter yesterday, Waxman urged FDA Commissioner Andrew C. von Eschenbach to suspend drafting of the new guidance and cooperate with a committee inquiry into the issue.

The draft guidance "would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs," Waxman wrote.

Companies would be less likely to conduct definitive scientific studies and seek formal FDA approval for alternative uses of drugs and devices if they could promote and profit from off-label uses anyway, Waxman contended. He said the proposal could grant undue influence to incomplete or distorted studies, some of them industry-funded. And he pointed to several high-profile cases in which drugs such as Vioxx and Celebrex were trumpeted in flawed journal articles that either underreported dangers or overstated benefits.

"While there may need to be a balance between First Amendment and protection of the public health," Waxman wrote, "the answer is not to open the door to unrestricted dissemination of potentially questionable information about drug safety and effectiveness."

FDA spokeswoman Rita Chappelle said the agency does not comment on letters from Congress.
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said it is "premature" to comment specifically on the FDA draft, but that providing the articles to doctors could help them make better prescribing decisions.

"These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care," the guidance says.

Some people depend on off-label uses of drugs, said Diane Dorman, vice president for public policy at the National Organization for Rare Disorders.

"There are nearly 30 million people in the United States affected by almost 7,000 known rare diseases," Dorman said. "Consequently, most of those disease states are treated off-label because there is no therapy specific for their disease. So getting that information to physicians, I would consider to be very, very important for the patient."

Football

I love football. I love big hits. I love the violence. I love the brutality of it. This is funny because neither my high school nor my college had football. I knew nothing about football until I met the spouse. 2005 is when I learned about the game and how it works. 2006 is the season I went crazy for it. But what continually amazes me is how often people DON'T get hurt. I just saw Fred Taylor get somersaulted by Bob Sanders by the sideline. He landed on his hand and rolled. But he didn't get hurt. That always blows me away.

Even though I LOVE big hits (they make me giggle), I don't like seeing someone get hurt. I can't watch Theisman's leg get broken. It turns my stomach. But I love the sound of a really good hit. And watching it in slow motion when I can see how their bodies contort? Most excellent.

My favorite player is Dick Butkis. But I wear Nathan Vasher's jersey every Sunday. It was a Christmas gift last year and was not easy to find. Even after he returned a missed field goal for 108 yards in 2005, not many people like him or want to wear his jersey.

Updation Nation

I am a bit behind on the whole posting thing. I've neglected ElJay, Facebook, and Blogspot. :(

Life is plugging along. We spent a great Thanksgiving weekend in Michigan with my family - saw my baby sister's house and my baby brother's girlfriend. The house is cute - it's a ranch house with a garage that got converted into a family room, so they're planning on adding a dining room table to that room and putting an island in the kitchen. The house is heated by a wood burning stove, which is cool. It's nice standing by the stove when your feets are cold. Their property is great - about five acres. The dogs LOVED it. They had things to sniff, things to bark at (still haven't figured out what they were barking at...), and places to pee. What else do you need? The girlfriend is nice. She's tall. I felt short. I am officially The Shortest Person in my family. By at least six inches. She dwarfs the sister also, making her The Second Shortest Person.

The weekend was nice and provided the inspiration for our gift to my parents. Shhh. It's a secret. It'll blow them away and create many tears in their eyes, which is always the goal. It'll be a lot of work for us, and, quite frankly, I'm dreading that. It'll be worth it. I hope. It better be. It's going to be Not Cheap. But that's ok. They deserve it.

We put up Christmas lights on the outside of our house Sunday. I was WORN OUT the rest of the day. I almost fell asleep during the bad bits of the Bears game. I stayed awake during most of it. When we moved upstairs to watch the Patriots almost lose to the Eagles, I could not keep my eyes open. The going to bed late and doing stuff outside things just caught right up to me and knocked me out. The spouse says it's because I'm getting a cold. I know it's the exercise intolerance inherent in fibro. The whole getting sick thing doesn't help, but colds don't wipe me out like that. Bronchitis doesn't wipe me out like that. I just used up all my spoons and had to pay for it.

Physically, I'm doing ok. It's kind of funny. I see people on Thanksgiving that I see only every other year. One of my great aunts asked how I was feeling and what kind of symptoms I have. Another aunt asked about the symptoms. I totally drew a blank! I know they're just trying to understand what I feel like. But all the knowledge and research I've done completely deserted me. All I could come up with was "I'm constantly achy and tired". I forgot about the cognitive issues, the sensitivity to medication and chemicals, and all the other things I live with every day. I think that's a good thing because it means that I don't dwell on it. I can't avoid the fatigue, sometimes bone-wearying, or the pain because they are omnipresent. I guess I've accepted the changes that fibro has wrought in my life; they've become normal. I don't know if that's good or bad. I really don't. It just is, and it's probably neither good nor bad.

I'm starting my two weeks of Feeling Not Good. It coincides with my hormones nicely, so I can predict it. It's backwards from what my doctor predicted (feel good after getting your period, feel bad before), but it coincides with what someone else I know experiences.

I'm trying to work out more. Everything I have been reading tells me that I'll feel better within about six weeks of starting to work out. The problem is starting. I feel good after I work out. I (kind of) feel good while I'm working out. But I feel so awful beforehand that it's hard to just start. I know that I lack motivation and all that, but, seriously, when's the last time you worked out when you had the flu? See? Not so fun. And I don't have the luxury of waiting until I feel better. I'm not going to all of a sudden get better one day. This is kinda how it's going to be until some serious advances happen regarding medicine and treatment options. Which is why I don't think about it.

On that note.....I am signing off. I'm glad my drafts get autosaved. :) It took me about three hours to write this!

First post!

Thought I'd try a new blog hoster. This one seems neat. I have a friend on here already - ChinaDoug - so that was a draw. :) Ok, I am way behind the power curve. My friend moved to Xanga. Oh well. I'll still keep this.

I won't be abandoning good ole ElJay, mostly because I know a lot of people on there, but I wanted to try something new. Variety is the spice of life and all that stuff.