What if there were a popular drug that had moderate benefits but was known to cause acute liver failure and death in some patients? Or another drug that had dangerous side effects including intestinal bleeding and ulcers?

Would it be right to let big pharmaceutical companies carry on marketing and selling them or ought they to be banned?

These drugs have existed for more than a century: they are paracetamol and aspirin. Perhaps they would not even be approved now for fear of toxicity but it is too late to withdraw them; instead, regulators periodically try to limit their use and to stop them being taken in combination with other medicines.

The point is that so-called “white pill” medicines, from painkillers to anti-cholesterol drugs, are chemicals that improve the health of some humans but can cause serious side-effects in others. Anyone who takes them needs to be informed about the benefits and risks.

But politicians are not good with balances of risk and reward, preferring black-and-white answers. This is why US politicians have been fiercely on the trail of Avandia, the anti-diabetes drug made by GlaxoSmithKline that has been linked with heart attacks. Like BP, another FTSE 100 company under attack, GSK is finding the political climate hard and capricious.

“Avandia is dangerous and should be pulled from the market,” declared Rosa DeLauro, a Democratic member of the House of Representatives last month, citing two studies. Senators from both parties have been putting heavy pressure on regulators at the Food and Drug Administration.

Such interventions are unwise for two reasons. First, politicians lack the expertise to judge whether drugs should be withdrawn. Some studies suggest Avandia heightens the risk of heart attacks; others that it is no more dangerous than a comparable drug. Politicians are not trained in how to sift such evidence

Second, and more importantly, there are people nearby who are far better qualified to make a sound decision – the FDA’s scientists. Congress has a pedigree watchdog to hand but has instead chosen to bark about particular drugs itself.

This is part of a pattern of political over-reach in business affairs, with Congressional committees cherry-picking thousands of documents they subpoena from companies to claim expertise on everything from oil-drilling techniques to derivatives. Presenting themselves as seekers after truth, they publish tiny extracts to embarrass executives.

Apart from the patent hypocrisy – they are really after scalps they can parade in front of voters – this is not their job. Their role is to make sure regulators are funded and correctly structured to let officials decide on complex matters such as prescription drug safety. . .

But regulators such as the FDA and the European Medicines Agency, which is now reviewing Avandia, are there because decisions over the risks and benefits of drugs – particularly as they are prescribed and taken in the real world – are difficult and finely balanced. A life-prolonging pill for one group of patients is poison for others.

Politicians have their own skills, but they should stop masquerading as doctors and scientists.

There are some of us who feel that the current pandemic can be laid at the feet of politicians who proclaimed medical practices without understanding epidemiology of respiratory infections.

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Subscribe MedicalTuesday . . .
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VOM Is an Insider’s View of What Doctors are Thinking, Saying and Writing about

What if there were a popular drug that had moderate benefits but was known to cause acute liver failure and death in some patients? Or another drug that had dangerous side effects including intestinal bleeding and ulcers?

Would it be right to let big pharmaceutical companies carry on marketing and selling them or ought they to be banned?

These drugs have existed for more than a century: they are paracetamol and aspirin. Perhaps they would not even be approved now for fear of toxicity but it is too late to withdraw them; instead, regulators periodically try to limit their use and to stop them being taken in combination with other medicines.

The point is that so-called “white pill” medicines, from painkillers to anti-cholesterol drugs, are chemicals that improve the health of some humans but can cause serious side-effects in others. Anyone who takes them needs to be informed about the benefits and risks.

But politicians are not good with balances of risk and reward, preferring black-and-white answers. This is why US politicians have been fiercely on the trail of Avandia, the anti-diabetes drug made by GlaxoSmithKline that has been linked with heart attacks. Like BP, another FTSE 100 company under attack, GSK is finding the political climate hard and capricious.

“Avandia is dangerous and should be pulled from the market,” declared Rosa DeLauro, a Democratic member of the House of Representatives last month, citing two studies. Senators from both parties have been putting heavy pressure on regulators at the Food and Drug Administration.

Such interventions are unwise for two reasons. First, politicians lack the expertise to judge whether drugs should be withdrawn. Some studies suggest Avandia heightens the risk of heart attacks; others that it is no more dangerous than a comparable drug. Politicians are not trained in how to sift such evidence

Second, and more importantly, there are people nearby who are far better qualified to make a sound decision – the FDA’s scientists. Congress has a pedigree watchdog to hand but has instead chosen to bark about particular drugs itself.

This is part of a pattern of political over-reach in business affairs, with Congressional committees cherry-picking thousands of documents they subpoena from companies to claim expertise on everything from oil-drilling techniques to derivatives. Presenting themselves as seekers after truth, they publish tiny extracts to embarrass executives.

Apart from the patent hypocrisy – they are really after scalps they can parade in front of voters – this is not their job. Their role is to make sure regulators are funded and correctly structured to let officials decide on complex matters such as prescription drug safety. . .

But regulators such as the FDA and the European Medicines Agency, which is now reviewing Avandia, are there because decisions over the risks and benefits of drugs – particularly as they are prescribed and taken in the real world – are difficult and finely balanced. A life-prolonging pill for one group of patients is poison for others.

Politicians have their own skills, but they should stop masquerading as doctors and scientists.

There are some of us who feel that the current pandemic can be laid at the feet of politicians who proclaimed medical practices without understanding epidemiology of respiratory infections.

Read more . . .
Feedback . . .
Subscribe MedicalTuesday . . .
Subscribe HealthPlanUSA . . .

VOM Is an Insider’s View of What Doctors are
Thinking, Saying and Writing about

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