FDA revokes Avastin (bevacizumab) licence for treatment of breast cancer

Amnesiac_ie

http://yourlife.usatoday.com/health/medical/breastcancer/story/2011-11-18/US-revokes-approval-of-Avastin-for-breast-cancer/51295370/1

I wonder will the HSE follow suit?

ClocksForward

Amnesiac_ie wrote: »

http://yourlife.usatoday.com/health/medical/breastcancer/story/2011-11-18/US-revokes-approval-of-Avastin-for-breast-cancer/51295370/1

I wonder will the HSE follow suit?

This has been on the cards for a while. Too bad these big pharma companies intentionally skew their data to make the drugs appear to be more efficacious than is actually the case:mad:

These companies are dangerous. The government needs to keep em on a leash. And I am no fan of state intervention, but they are clearly abusing their position.

Kurtosis

The licence for Avastin here was issued by the European Medicines Agency, so any changes to the indications will come from the EMA and apply across the EU.

ClocksForward wrote: »

This has been on the cards for a while. Too bad these big pharma companies intentionally skew their data to make the drugs appear to be more efficacious than is actually the case:mad:

These companies are dangerous. The government needs to keep em on a leash. And I am no fan of state intervention, but they are clearly abusing their position.

Is there any evidence that the manufacturer of Avastin (Roche) intentionally altered data in order to gain approval?

ClocksForward

penguin88 wrote: »

The licence for Avastin here was issued by the European Medicines Agency, so any changes to the indications will come from the EMA and apply across the EU.



Is there any evidence that the manufacturer of Avastin (Roche) intentionally altered data in order to gain approval?

Take a look at their "data"

None of the their figures are in line with the claim that Avastin does not extend life for breast cancer patients. The figures are intentionally misleading. Given incorrect data, how can the FDA approve a drug which is 100,000+ and is basically no better than a placebo?

This is research misconduct of the highest degree. If somebody in my field tried to pull a stunt like this off they would lose their licence and face trial. I thank modern medicine for all their innovation, but it's disturbing to see how pharma shills mostly rule the roost these days when it comes to medical treatments:(

Call me an idealist, but there is a level of honest integrity missing from medical research these days. Big Pharma are simply pulling their strings in this case. These drugs should not be approved if they aren't proven to be efficacious over the long term.

Kurtosis

ClocksForward wrote: »

Take a look at their "data"

None of the their figures are in line with the claim that Avastin does not extend life for breast cancer patients. The figures are intentionally misleading. Given incorrect data, how can the FDA approve a drug which is 100,000+ and is basically no better than a placebo?

This is research misconduct of the highest degree. If somebody in my field tried to pull a stunt like this off they would lose their licence and face trial. I thank modern medicine for all their innovation, but it's disturbing to see how pharma shills mostly rule the roost these days when it comes to medical treatments:(

Call me an idealist, but there is a level of honest integrity missing from medical research these days. Big Pharma are simply pulling their strings in this case. These drugs should not be approved if they aren't proven to be efficacious over the long term.

I'm on a mobile at the moment so can't be 100% sure but it appears that link relates to a different indication for Avastin, metastatic carcinoma of the colon or rectum (MCRC) and not breast cancer. And again, after a quick glance, their data seems to indicate a significant improvement in survival at 1and 2 years (non overlapping error bars). I will look at this in more detail when I'm at a computer.

I do realise some pharmaceutical companies have engaged in publication bias, however I am curious as to whether there is any basis to the claim that the manufacturer of Avastin has done this or deliberately skewed the data to gain approval as a breast cancer treatment.

boardswalker

I am not sure that there ever was good evidence for Avastin in the treatment of Breast Cancer.

From the FDA website
"Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.

FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication. Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That hearing took place June 28-29, 2011."