Thursday, July 31, 2008

Testing testing.....

1 week into my mothers hospitalisation, & things seem to be working out pretty OK.....

The doctors have proposed my mother be put on a trial run of a new drug, currently going through testing before being approved by the FDA. It's supposed to be a superior anti psychotic drug that assures effectives, yet producing little or no side effects, or so the pharmaceutical company tells us. The programme is being supervised by University Hospital and is headed by some Professor who will facilitate the programme.

The hospital gave me a 17 page long Informed Consent Form for my mother so sign, detailing all the medications & observations that will be done during the t6 week long trail. I read it long and hard, and discussed it with my brother and some other concerned people, and the way I see it, some of the pros and cons:

Pros:

  • Full cost of hospitalzation for the next 6 weeks fully covered by the Pharmaceutical company.
  • Free extensive full body medical check up for my mother, including ECG, full blood test, urine test, psychiatric evaluation, movement test & medical care as long as she is on the programme.
  • New cutting edge that (supposedly) will be superior to what is on the market, with successful test already completed in the US, Europe, and only now, Asia.
  • Mother will be watched like a hawk, every observation written down, and we will have full access to these information.
  • Reduce my financial burden & give me adequate time to fine a good nursing home for my mother.
  • For a change, doctors will be interested to see her progress, instead of us chasing after doctor for a remedy.

Cons:

  • God knows what sort of effect this will have on her. After all, its not FDA approved.
  • What about any long term effects if the drug proves harmful? The Pharmaceutical company is only covering immediate medical treatments.
  • It IS an experiment, and if un-effective, we will just have to go back to square one and start over again - waste of our time, and not fair to my mother.
  • Dosage is random i.e. there are 4 possible drug strengths that will be used. More on this below.

Now, you tell me, how do the odds look?

Ready, the great thing about it all is just 3 points. My mother will be receiving full & diligent medical & psychological care & observation. She will get a full body check up, which is darn expensive if we did it ourselves on the outside. And lastly, the drug us FREE, and supposed to be the latest on the market. So far, most people I have ask think that we should go ahead.

But maybe its just the uneasy feeling of threading on unfamiliar ground, but I still have that nagging feeling of uneasiness. Just imagining the worst case scenarios, what will happen if the drug turns out to be harmful? Permanently? No doubt, the company will nurse her back to a stable condition before returning her to us, but what if she can't go back to normal? But realistically, she has been neglecting medication for almost a year now, and I suppose things can only go up with her taking medication. Better some sort of medication than no medication at all.

But the idea of enrolling my mother seems to be a little cold & heartless. As per the programme, the test subject will be randomly assigned 1 of 4 possible dosages. Tablets with 120mg of the compound, 80mg, 40 mg or none at all, called a placebo dose. So basically, during the 6 weeks of observation, they would have no idea what they are giving my mother. It could be a proper dose, or it could be a placebo, in which case, she would show no improvement and be taken out of the programme. The placebo dose is supposed to be sort of a control I guess, kind of like what you need during a experiment in the science lab. After the 6 weeks, if effective, we would be enrolled in a 22 months programme, where she will continue to receive the new drug, at a regulated dosage this time. Hopefully by the end of the 2 years, the drug will have already been released into the market.

In all fairness, I do not think the doctors, or the nurses or the government are being crazy unscrupulous in allowing a test medicine to be given patients. In fact, it is perfectly common prior to a drug being released into the market. I took the whole weekend to finally come to a decision my heart felt comfortable with. We will go through with the programme, with the hope that it would indeed be effective for my mother. After spending half my life battling this problem, its high time we tried something different. Other drugs seems to work, but only for a while.....It is with this hope for the future that we commit this decision....