Millions of cancer patients have utilized chemotherapy over the last thirty years with no appreciable decrease in mortality rates. This has created a market for a new type of drug that specifically targets rapidly dividing cancer cells in hopes of sparing the healthy cells. Could this emerging therapy be the answer we have been looking for?
Let’s step back a moment and review the politics and the money trail before we make any objective conclusions on the current state of targeted cancer therapies. The concept is very promising, but premature approvals, lack of follow up studies and grossly inflated price points have left many scratching their heads and holding their wallets.
Avastin was the first of the “angiogenesis inhibitor” drugs to be approved by the FDA, and it works by decreasing the formation of blood vessels in the tumor in hopes of decreasing its growth potential.
This expensive concoction was prematurely approved by the FDA in 2004 for colorectal cancer but has also been used “off-label” for management of many other diseases, with no supporting studies having been completed.
Once Avastin received its premature approval from the FDA, its maker invested in an aggressive tactic to gain approval for the drug to be prescribed for many additional cancers. An advisory committee was created to evaluate new trials that have been done on Avastin.
The committee reviewed two trials that did not provide any survival data, and its members unanimously agreed that these studies did not confirm the impression of the earlier studies that resulted in the initial approval of the drug. The newer studies simply failed to show that Avastin prolonged survival rates, with one study concluding that Avastin may delay tumor growth by a mere 30 days. This means that if you are taking Avastin, your tumor growth will take a 30 day break and then begin where it left off. During the 30 day delay, your wallet will be smaller and your body will have to deal with the side effects of Avastin.
Back in December of 2007, an FDA panel voted 5 – 4 against the approval of Avastin for breast cancer. However, the FDA commissioner at the time, Andrew C. von Eschenbach, MD overuled the decision by this panel of experts and approved the drug. Why would the commissioner overturn the ruling of this entire panel and declare Avastin to be safe? Probably because that simple decision will create $500-700 million a year to Genentech, the company that patented it!
The concern is not only the overruling of the advisory board but the fact that the FDA rarely revokes an approval once it has already been granted. A recent governmental report actually showed that, of the last 90 drugs that have been given premature “accelerated” approval, not one has been removed from the market. It also pointed out that in numerous cases, the additional studies that were required to be done to maintain the approval have not in fact been done.
If you are interested in a comprehensive report of the clinical trials, the side effects and the effectiveness data of Avastin, visit http://www.cancerdecisions.com/ for an excellent report written by Ralph W. Moss, a leading researcher in cancer therapies.