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Tuesday, June 8, 2010

BioSimilars, BioEquivalents,BioIdenticals Say What?

Ok as the world progresses so does medical technology. And then the "me too" greed sets in. Such is the case with medicine.

As pharmaceutical companies find a cure or a treatment for a condition (I am going to use growth hormone deficiency as my example because I know a little about it)...they spend millions and sometimes even billions of dollars in R & D (Research & Development) to develop the drugs. And when they go through the process they do testing in the labs, and after years of refining their information and animal testing, they go into trials with people. And even more years later, IF the trials all prove "good" they approach the FDA (Food and Drug Administration) for a license to provide the drug to the public.

This process takes years and years and MAJOR money. It is also HIGHLY scrutinized and evaluated on many levels. And to give drug companies the incentive to keep doing research for cures etc. they are granted a license to be able to exclusively sell their product (without anyone being able to copy and sell it cheaper) for a few years (around 7 years I think).  This is good because without this incentive, drug companies would have no reason to search for cures. Why would they put out that kind of time and HUGE investment, if they couldn't be guaranteed that some "me too" company would "Copy" their product and sell it cheaper? The answer is...they wouldn't! So for all of us who use any kind of medicine...we need drug companies to be protected (within reason) so that they can keep searching for new drugs and better drugs.

Now for those of us with kids who have needed growth hormone, we all know that process is important but we also went into shock when we found out how much growth hormone cost! I know I did! We went into full blown panic. But to be fair, drug companies set the cost of drugs they discover based on the patient population that they expect to benefit from a drug. In other words, because they "estimated" that only 20,000 kids would need the do they recoup their millions of R & D? They price it high! And Insurance companies fight the parents trying to help their kids...and the world gets nasty and messy. In the end, it is the kids who may go without the med, the parents who are destroyed with guilt or panic over how to help their kids who are hurt by what should have been a medical miracle.

So drug companies have put "help" out there to families. Thank God because no Insurance company would!

And now that GH has been available via a safe BioIdentical drug for a while....the "me too's" are starting to pop up.

So what does this mean?

It means that companies who have a "bioSimiliar" or "bioEquivalent" drug (which is NOT the exact as the original products) can now make deals with Insurance companies to FORCE them to only pay for their "cheaper" drugs.

Why do I think this is dangerous?

1. It allows for people "in the world somewhere" with Insurance companies to mandate medical treatment.
2. It allows for a less than optimum product to be used without regard to the patients in favor of an economic savings.
3. It allows for a product which does NOT go through the same rigorous testing-to be used on ...US! And our children....

And with the "new" health care plan being set up....they are favoring the generics instead of the name brand original drugs. If your body cannot benefit or has a reaction to the less than original drug (meaning the generic) have no choice! Either pay out of pocket or ....suffer!

When people work hard to provide Insurance for their families, pay each month....and then are told NO...what is going on? Next we will be fined if we brush our teeth from left to right instead of right to left!
There are so many people in this country who want to do good but the opportunity is not there. Some how someone needs to set up something and hold true so that the faith in our system can be restored. For the the people!

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