Pharmaceuticals

Back when this first came up, my doctor immediately moved me to Actos, which seems to work about the same for me. So I was lucky in that regard.
The drawback is that Actos is beyond-belief expensive, about US$500 for a three-month supply.

We should not forget that, at the end of day GSK is a company which is supposed to reward it investors and employees. Cut –throat competition because of the limited range of drugs to offer and cheap generic drug production is forcing these companies to cut back on research and setup performance targets for the R&D department.
A block-buster drug is essential pill for the future of firma and to justify the high investment in R&D. The targeted drug development has failed to take off because of experimental failures and, high regulatory and investment barriers.
So I don’t see any reason why a drug would not be marketed by a company even if the R&D department or regulator (FDA) believes that it would risk the life of patients. At the same time we cannot crush the innovation in the pharmaceutical industry which is already reeling under the regulatory pressures.

The subtext of the Avandia and Vioxx stories is that even the most ballyhooed new drugs are rarely true "blockbusters". What's especially discouraging is that these few that end up on the market are just a tiny fraction of those that once looked promising in the lab. The sad conclusion is that for all the billions being spent on drug development, and all the good biochemistry that is a side effect of the research, really useful new drugs are extremely rare -- perhaps a once per decade event. Either all the good drugs have already been discovered (you can do a lot with opium, aspirin, penicillin, and sufadiazine, and steroids) or the drug development process is fundamentally flawed. I'm one of those who tends to think that any new information added to the accumulated body of human knowledge is good, but in a strictly goal-oriented analysis, drug development is a failure.

As a practicing doctor it is not difficult for me to stick to the traditional dictate of the medical profession..."at best cause no harm". Therefore pending when 'in the best interest of the patient' prevails in the ensuing debate - significant disasters related to this drug for individual patients (which is 100%) would have been avoided - at least from my personal action.

If the drug's risk/reward profile is unique, it should continue to be allowed on the market. Some people will suffer from a problem (in this case, diabetes) while being at low risk for the corresponding complication (in this case, heart attack.) Those people should be allowed to use the drug. Individuals are unique. They should be allowed as many options as possible.

The pharmaceutical industry is absolutely not trustworthy, the plaintiffs' bar is just as bad, and the FDA is desperately underpowered. The only possible solution is to improve the FDA.

The real crime here is doctors still prescribe it.

Let's be clear about something, an increase of 43% in heart attacks is not an absolute increase but a relative increase. Namely if the rate of heart attacks in the normal diabetes population is 5% a year, the new rate is about 7.5% (~5% * 1.43). If you had no other choices for drugs and your options were to have uncontrolled diabetes, you may very well risk taking the drug.

Cleo Katsivela is wrong to say that " in almost half the cases, the drug causes heart attacks ...."
The facts are that the probability of stroke, heart failure or death is increased when compared with an alternative drug but this amounts to an attributable risk for this composite end point of 1.68 excess events per 100 person-years of treatment with Avandia compared with other oral diabetic drugs. The corresponding number needed to harm was 60 treated for 1 year.

The problem facing the FDA and patient's doctors are that there are cases where other drugs do not work and Avandia does. Not treating the patient with Avandia, in these cases has a uniformly fatal outcome.

It is interesting that in the case of Vioxx, there where patients left in intractible pain when they lost access to Vioxx

Hhmm.
Firstly, the Vioxx comment is correct. Merck pulled it as a financial decision. Vioxx is no worse and no better than any of the other selective COX - 2 inhibitors. It merely attracted more attention in the media and was probably too hard to defend. It is probable that celecoxib and rofecoxib have exactly the same adverse effects but did not get the same coverage and have therefore not been removed.
Secondly, no drug is free from side effects. NONE. What is important is that these side effects are transparently communicated to both the doctors prescribing them and the patients that are taking them. Then, an informed decision can be made to balance the risks versus the benefits for the individual concerned and evaluate whether this drug is going to be a good idea for that individual.
The FDA have decided that in certain patients the risks of taking Avandia are less than the benefits. But this is not the case for all patients.
Predictably, the American legal system will take this to mean it is open season on GSK for any patient that has a side effect from Avandia.
Lastly, to assume that any and every side effect is known or predictable from clinical trials is naive. To use several hundred or at best several thousand as your study population is a best intention. That is why ALL drugs have some degree of post release surveillance so that unexpected side effects can be picked up.
Dont get me wrong, drug companies are not saints, they are commercial enterprises with vested interests. However, the economics for drug development are currently pretty miserable and are going to get worse. We will all be worse off if sensationalist, knee jerk reactionism and punitive law over-ride rational analysis of the facts.
For most of us it is still best to stick to old and boring medicines until the "fancy new drugs" have stood the test of time.

It is very hard to read the article and not feel rage, as a taxpaying citizen and as a human being, against the stance of the scientists and lawmakers.
Because what they are saying is that in almost half the cases, the drug causes heart attacks and, in spite of the evidence they are afraid to pull it out of circulation since “…to do so would be to admit that a drug they previously deemed safe was, in fact, not so”.
Is it only their fame they care about and not their true mission, which is to protect the public’s health? What keeps them from honestly admitting that they made a mistake, and then try to make amends in order to prevent further damage? And if “the balance of risk and benefit intrinsic to any powerful drug remains in favor of the latter” from the patient‘s point of view, who is going to protect those patients from their own self: that is their agony and the consequent despair to try anything promising to restore their health and console their pain? Isn’t that the role of law and regulation? Isn’t the law supposed to protect from any criminal act against humans, be that a criminal act deriving from drug companies and/or scientists or from our own despair? Isn’t the failure to exercise its institutional role a synergy to the crime? For, in my opinion, the cautiousness and even reluctance that the FDA is exhibiting in this case, is criminal. Not to mention the scientist’s criminal type naïveté (I do not want to accept there is intention there) to make a drug, without fully eliminating the risks to other organs and to take for granted that the side effects are “intrinsic to a any powerful drug”.
As one of the brightest minds of our times, the greek writer and gnosiologist, Mr Ioannis Tsatsaris, remarks: “…if you cure one illness which assaults one other part of the body and, at the same time, you create another, somewhere else, it means that you are condemning man to an interminable hell, for he will continually suffer, something which is not right. Medicines ought to be given assistance in healing without assailing anything else in (the)… organism” (The Next Step of Creation, The Revelation, Vantage Press NY, pag.198).

Cleo Katsivela, LLM, Civil Law Notary, Athens, Greece.

Don't mean to play savvy here, but may I correct: the decision to pull Vioxx was made my Merck itself (probably ahead of the FDA anyway, and with the purpose of lessening the impact of the bad news). But that's the way it was, to the best of my recollection.