Thursday, July 12, 2012

Take this drug and get some money!!

Although my family was a single-mother family, in many ways, I had 3 parents. My maternal grandparents were a presence in my life I think from the day I was born, but certainly as far back as my memory goes. We lived with them from the time I was maybe 5 or 6, I think, because my mom worked 3rd shift as a nurse and needed to have proper care for me, my brother and my sister. So, not to belittle the efforts of my mom (which were considerable!), I feel like a lot of my rearing and upbringing belongs to my Grandma. And my Grandma always said that anything worth having was worth working for.

My Grandma, of course, came up during the Depression and was no stranger to hard work... her entire life. In fact, she had to work entirely too hard her whole life. But I don't remember her ever complaining about it, or wishing for the lottery or some other windfall that would allow her (or my mom, my Grandpa or any of us kids, for that matter) the opportunity to not work. Work was expected.

These days, though, I don't know what happened to that mindset. Everyone seems to want everything, for nothing. Of course, people play the lottery and dream... but that's not what I'm even referring to.

There seems to be at least one commercial during every TV show that starts, "Did you or someone you love take the prescription drug...", followed by "YOU MAY BE ENTITLED TO A CASH SETTLEMENT!"

What the...?????

Now, these aren't settlements regarding unregulated "medicines", tonics, herbs, vitamins, supplements, etc. These are prescription drugs that went through FDA clinical trials, etc. Each of these drugs are prescribed for a medical condition, and have warnings regarding side effects, etc. It is at the discretion of not only the prescribing physician but the patient him or herself whether or not the risk of side effects outweighs the benefits of taking the drug.

Maybe 12-15 years ago, as I recall, people who struggled with their weight saw the FDA approval of Phen-Fen, a combination of 2 drugs that showed remarkable success in losing weight. People were lined up to go on the drugs. They didn't have to necessarily "diet" or exercise, but would still lose weight. NOW, common sense says that eating what you want and sitting around on your butt but still losing weight just doesn't add up. There were, of course, risks and side effects. People, though, always think that they won't be the ones to suffer the side effects.

Well, lo and behold, many people did develop side effects of the drugs, including damage to their heart. They all got together to form a class and brought class action suit against the drug companies. And they got paid! Not just the health care services needed to treat the cardiac complications, but for damages too. Pain and suffering.

What the...?????

So basically, people who took a short cut and avoided the actual work needed to drop weight were rewarded for their laziness? Ridiculous!

Now, I am not saying that the drug companies, or even the FDA for that matter, are "innocent". The truth of the matter is that as a society, we want quick and easy solutions to everything. There's GOT to be a pill (or two or twelve) to cure whatever ails you. If there's not, then we have to find one. Perhaps these drugs are being rushed through clinical trials for FDA approval so that they can be marketed. In that case, the FDA needs to review and amend their requirements for approval. But let's be honest. We as consumers are clamoring for these drugs to be approved for use as quickly as possible. How many times do we hear a story about someone suffering from an ailment. There's drug X that's in clinical studies and the preliminary results are so promising! Yet the big bad insurance company won't pay for the drug! How terrible! Yet it seems that those preliminary results (and we all know what the word preliminary means, right?) are just that. If we can allow the clinical researchers to complete their trials, maybe we find out that the drug isn't as wonderful as it was first thought.

Lately, I've heard commercials for not only some chemo drugs that were used in off-label treatment protocols, but also drugs for treatment of conditions such as arthritis pain, high blood pressure, diabetes, and birth control. The one for birth control is actually what prompted my thoughts on this topic, which in turn led to this rant.

Those of us who have taken advantage of the various methods of birth control that are available have all been advised of the risks of the birth control, including developing blood clots, increased risk of stroke, etc. The commercial I saw was urging women who were using Yaz and developed blood clots or suffered a stroke to call a specified law firm, as they may be eligible for monetary compensation.

WHAT THE...??????

So, they were told of the risks/side effects, chose to use that method of birth control, experienced the side effects and now they get paid? You can't be serious!

If there is clear evidence that a drug company lied to or misled the FDA in order to gain approval, that's one thing. That, to me, falls under malpractice. In the absence of that, though, it's just part of life. A sucky part, perhaps, but still just life.

What happened to accepting responsibility for the repercussions of one's actions?

The FDA needs to review and amend their approval protocol for drugs, and require ongoing study of approved drugs for up to 10-15 years or longer. We know that as a society, we are getting sicker younger because of a failure to take care of our health. Whereas diabetes and high blood pressure were typically found in aging adults, it's not uncommon for people in their 20s and 30s to have these diseases. Since these diseases are primarily managed using medication, we need to know what these drugs will do to our body when used for 10, 15, 20 or more years. If we were 60 years old at the time of diagnosis, chances are we wouldn't be on the drug for 20 or more years. If we're diagnosed in our 20s and 30s... chances are, we will be! What kind of toll are these drugs going to take on us? We need to know.

The second part of the solution here is to strictly limit the type of litigation that can be brought.  If a medication is used for an OFF LABEL condition, then the only claims that should be able to be filed are for actual damages, i.e., the cost of the medical care needed to treat whatever the side effect is. Not a single cent more.

If the drug was prescribed for the approved condition, then no claims at all can be filed if side effects are developed. It was a risk that the patient was made aware of and accepted. Therefore, accept responsibility for your decision. Period.