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Weight Loss
Pharmaceutical Giant Fails to Impress With New Obesity Drug
Date: 23/07/10
Just when you think there’s no hope for government health agencies, one small glint of light appears at the end of the tunnel.
Even though it’s just a tiny spark in the dark at this stage and may ultimately be extinguished, it’s definitely worth a mention.
FDA health advisers say no to ‘fat pill’
When Vivus Inc. started to develop the first new prescription-only anti-obesity pill in a decade, Qnexa, they must’ve had visions of all the bags of money their once-a- day diet pill would make them... Especially since government statistics show that nearly 70 per cent of people in the US are overweight, and more than 30 per cent of them are obese – and that’s just the US market...
Their vision of making millions of dollars in profits was shattered last week when a panel of health experts, advising the American Food and Drug Administration (FDA), dealt a surprising blow to this highly anticipated anti-obesity pill.
The panel voted 10-6 against Qnexa.
Their verdict: safety concerns outweighed the drug’s ability to help obese patients shed pounds.
The advisers agreed unanimously that Qnexa could help patients lose pounds, but the benefits were outweighed by a slew of safety concerns that cropped up in medical trials, including memory lapses, suicidal thoughts, heart palpitations and birth defects.
FDA panellist Elaine Morrato of the University of Colorado said approving Qnexa would be a huge public health experiment.
Too early to celebrate
As I mentioned earlier, there is a massive market to be exploited world wide, especially with the current obesity epidemic in both the UK and the US. Pharmaceutical companies have seen this gap and are taking full advantage of it.
Over the past decade, many anti-obesity drugs like Orlistat, Xenical and Alli have been launched.
Whilst some of these – like Orlistat – carry specific label warnings about its adverse side effects, others – like Alli – can be bought over the counter and its side effects are downplayed and often not fully disclosed to the public...
Ironically, all three of these drugs cause increased digestive discomfort and serious nutritional deficiencies. Now, isn’t that taking losing weight to a completely different level by inducing malnutrition? To read more about this, follow the link:
Most concerning is that these drugs all won FDA approval and are still available either over-the-counter or on prescription, despite health concerns surrounding their use.
The same could happen with Qnexa.
The 10-6 vote against Qnexa is merely a negative opinion.
Panellists who voted in favour of the drug said they hoped the FDA would still approve Qnexa, despite the vote results...
Those familiar with the shenanigans of the FDA will know that the agency rarely allows a negative vote to influence the approval of drugs - or their withdrawal for that matter, as was the case recently with Avandia - the diabetes drug dogged by controversy. (Last week the FDA decided against withdrawing Avandia from the market despite the American Diabetes Association’s warning that Avandia can cause serious heart problems.)
As we also know, Big Pharma doesn’t take ‘No’ for an answer easily, even if it means risking public health with a drug like Qnexa causing depression, suicidal thoughts, heart palpitations and birth defects...
Getting the right message across
Last week I told you about the UK Health Secretary, Andrew Lansley arguing that it is wrong to lecture people about their eating habits and that it is “perfectly possible to eat a bag of crisps, a Mars bar or drink a carbonated soft drink in moderation”...
In his wisdom, Lansley also plans to employ junk food manufacturers to give nutritional advice, by making them pay for government advertising campaigns to persuade people to switch to a healthier lifestyle...
To add to this mixed message, whilst many people already make poor decisions about their nutrition, harmful anti- obesity drugs seem to be a free-for-all.
One thing many people trying to lose weight forget is that these anti-obesity drugs only work for as long as you use them... Combine this with mixed messages from so-called health experts, pharmaceutical giants pushing out quick- fixes faster than a doughnut machine and an ill-informed public given a license to continue eating unhealthy foods, we’re most certainly heading for disaster!
No wonder Britain and the US are busting out of their skinny jeans!
So here goes:
Weight loss starts with a healthy balanced diet, reduced portion sizes and an active lifestyle. NOT dangerous pharmaceuticals.
Simple.
Sources:
‘U.S. advisers reject Vivus' fat pill’ published online 15.07.10,ReutersHealth.com
‘FDA panel rejects experimental weight loss pill’ published online 16.07.10, Associated Press
‘US labels for orlistat add liver damage reports’ published online 27.05.10, rajpharma.com
Back to topEven though it’s just a tiny spark in the dark at this stage and may ultimately be extinguished, it’s definitely worth a mention.
FDA health advisers say no to ‘fat pill’
When Vivus Inc. started to develop the first new prescription-only anti-obesity pill in a decade, Qnexa, they must’ve had visions of all the bags of money their once-a- day diet pill would make them... Especially since government statistics show that nearly 70 per cent of people in the US are overweight, and more than 30 per cent of them are obese – and that’s just the US market...
Their vision of making millions of dollars in profits was shattered last week when a panel of health experts, advising the American Food and Drug Administration (FDA), dealt a surprising blow to this highly anticipated anti-obesity pill.
The panel voted 10-6 against Qnexa.
Their verdict: safety concerns outweighed the drug’s ability to help obese patients shed pounds.
The advisers agreed unanimously that Qnexa could help patients lose pounds, but the benefits were outweighed by a slew of safety concerns that cropped up in medical trials, including memory lapses, suicidal thoughts, heart palpitations and birth defects.
FDA panellist Elaine Morrato of the University of Colorado said approving Qnexa would be a huge public health experiment.
Too early to celebrate
As I mentioned earlier, there is a massive market to be exploited world wide, especially with the current obesity epidemic in both the UK and the US. Pharmaceutical companies have seen this gap and are taking full advantage of it.
Over the past decade, many anti-obesity drugs like Orlistat, Xenical and Alli have been launched.
Whilst some of these – like Orlistat – carry specific label warnings about its adverse side effects, others – like Alli – can be bought over the counter and its side effects are downplayed and often not fully disclosed to the public...
Ironically, all three of these drugs cause increased digestive discomfort and serious nutritional deficiencies. Now, isn’t that taking losing weight to a completely different level by inducing malnutrition? To read more about this, follow the link:
Most concerning is that these drugs all won FDA approval and are still available either over-the-counter or on prescription, despite health concerns surrounding their use.
The same could happen with Qnexa.
The 10-6 vote against Qnexa is merely a negative opinion.
Panellists who voted in favour of the drug said they hoped the FDA would still approve Qnexa, despite the vote results...
Those familiar with the shenanigans of the FDA will know that the agency rarely allows a negative vote to influence the approval of drugs - or their withdrawal for that matter, as was the case recently with Avandia - the diabetes drug dogged by controversy. (Last week the FDA decided against withdrawing Avandia from the market despite the American Diabetes Association’s warning that Avandia can cause serious heart problems.)
As we also know, Big Pharma doesn’t take ‘No’ for an answer easily, even if it means risking public health with a drug like Qnexa causing depression, suicidal thoughts, heart palpitations and birth defects...
Getting the right message across
Last week I told you about the UK Health Secretary, Andrew Lansley arguing that it is wrong to lecture people about their eating habits and that it is “perfectly possible to eat a bag of crisps, a Mars bar or drink a carbonated soft drink in moderation”...
In his wisdom, Lansley also plans to employ junk food manufacturers to give nutritional advice, by making them pay for government advertising campaigns to persuade people to switch to a healthier lifestyle...
To add to this mixed message, whilst many people already make poor decisions about their nutrition, harmful anti- obesity drugs seem to be a free-for-all.
One thing many people trying to lose weight forget is that these anti-obesity drugs only work for as long as you use them... Combine this with mixed messages from so-called health experts, pharmaceutical giants pushing out quick- fixes faster than a doughnut machine and an ill-informed public given a license to continue eating unhealthy foods, we’re most certainly heading for disaster!
No wonder Britain and the US are busting out of their skinny jeans!
So here goes:
Weight loss starts with a healthy balanced diet, reduced portion sizes and an active lifestyle. NOT dangerous pharmaceuticals.
Simple.
Sources:
‘U.S. advisers reject Vivus' fat pill’ published online 15.07.10,ReutersHealth.com
‘FDA panel rejects experimental weight loss pill’ published online 16.07.10, Associated Press
‘US labels for orlistat add liver damage reports’ published online 27.05.10, rajpharma.com
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