I don't have a lot of time for pharmaceuticals - especially for those associated with weight loss, but there's a new one that's about to receive FDA approval. So I thought I'd do a little bit of research and find out what all the fuss is about.

Here's what I found out - on the day the FDA panel voted 20 to 2 in favour of approval, the manufacturer's stock jumped 98%.

So that's great isn't it?

FDA approval means it's safe and it does what it claims it will do - doesn't it?

And that's got to be really good news for people struggling to lose weight - hasn't it?

Well...

One of the things most people don't know about pharmaceutical solutions is that all drugs have side effects. What approval means is that the benefits outweigh the side effects. Sometimes drug side effects are quite severe, but if the drug means the difference between life and death then the severe side effects can be tolerated. If it's an over the counter preparation (OTC) available without prescription then the side effect tolerance is much lower - in theory at least.

So how does this new drug work and will it really help you to lose weight?

The new drug contains the 'old' drugs phentermine and topiramate.

Phentermine

Phentermine was part of a diet drug marketed in the 1980's but it was withdrawn because it damaged heart valves. It works like amphetamines and suppresses appetite. It has two sigificant side effects - tachycardia and elevated blood pressure. Interestingly, the FDA is concerned about heart risk with phentermine and is looking at the possibility of further studies - but these will only be required after approval and not before. Safety seems to me to be taking a back seat when there are billions of dollars waiting to be made.

Interestingly the appetite suppressant effect of phentermine only acim  a few weeks, so the problem will be to stop people increasing the dosage when this happens. Especially if they have enjoyed watching the pounds fall away effortlessly.

Increased dosage means increased risk.

But let's not ignore the other drug - topiramate.

Topiramate

Here are some of the listed side effects:

Depression, confusion, chest pain, memory loss, difficulty breathing, concentration problems, hallucinations, difficulty with speech, fainting, mood swings, paranoia, fatigue, vision difficulty and eye pain, wanting to sleep, deep vein thrombosis, suicide, hyperglycemia, kidney stones, and allergic reactions.

42% of people taking this drug reported cognitive or mental problems.

The new drug itself seems to be causing serious concerns relating to cardiovascular problems (just as with most other miracle weight loss drugs that had to be withdrawn) and also possible birth defects (cleft lip cleft palate). The solution to this, suggested by the manufacturers, is adequate birth control!

So it's looking good so far.

But when we look a little deeper into this we begin to see something more than a wonder drug that will bless humanity.

FDA - going through the motions

Before the vote the FDA prepared a 161 page document espousing the new drug's benefits and strongly recommending approval. The FDA, by the way, gets most of it's funding from the pharmaceutical industry. Isn't that a bit like letting the criminal fraternity run the Justice System? It seems that wisdom, and the safety of those that FDA is supposed to be protecting (the American people), fall by the wayside in the FDA's desperate attempt to come up with an 'easy solution' to the obesity epidemic that the US is suffering from. And, of course, the medical mindset is that the only solution is a pharmacological one. Never mind encouraging people to do something simple and safe like eating a little less and exercising a little more.

The problem, it seems, is that there is no competition for this new drug, so everyone who wants to carry on eating and make no changes to their lifestyle sees this as an easy option. Every one will want it. Everyone wants the easy option. Even though a prescription will be required it will be available without through internet sources and the manufacturers will make billions of dollars.