(NaturalNews) AstraZeneca has come out making bold claims about their new experimental ovarian cancer drug called olaparib. In clinical trials, the drug company shows that their new drug enables an 83 percent reduction in the risk of ovarian cancer progression.
According to a review by officials from the US Food and Drug Administration, this 83 percent statistic most likely couldn't be reproduced.
"AstraZeneca has put up some pretty lofty expectations," said Damien Conover, an analyst at Morningstar.
The drug is designed to be a maintenance therapy for recurring ovarian cancer that has only partially responded to platinum-based chemotherapy. Could the drug's efficacy rate even be proven since it's used as a secondary, follow-up drug to chemotherapy?How can the success of these two therapies be differentiated?
For that matter, how can the efficacy of the platinum-based chemotherapy and/or the new drug be measured if it's the person's immune system that is overcoming the cancer? Drug companies can't market patients' own immune systems.
In the end, could it be that the two treatment methods are actually diverting energy away from immune system empowerment and cellular energy production?
Meanwhile, olaparib awaits FDA approval. The future of this multi-billion-dollar cash cow hinges on the decision of FDA staff. An FDA staff report, recently published on the agency's website, is preparing discussion with outside experts who will weigh the benefits versus the risks of the new drug. The FDA's decision usually hinges on the advice of these expert panels. If it is approved, olaparib is already set to be sold under the brand name Lynparza.
Clinical tests are vague, making general correlations that cannot be proven
The new drug intervenes in the body by blocking poly(ADP-ribose) polymerase (PARP) activity. This enzyme plays an important role in cell repair.
According to the clinical trials, ovarian cancer patients witnessed median improvement of seven months for progression-free survival. This test basically just measures the amount of time a patient lives without the cancer showing any signs of progression. The test does not show whether the drug is mitigating the cancer progression but does show a general correlation (that cannot be effectively proven or consistently replicated).
Measuring quality-of-life factors like energy levels and strength recovery are not included in this clinical test either. Likewise, the drug's ability to prevent other health problems and future cancers is not included in the test. To make matters worse, olaparib boasts a new set of side effects for the body to handle along with the cancer -- nausea, fatigue, abdominal pain, vomiting, diarrhea and anemia.
Drug has potential to mislead women into taking it as a "preventive" measure
The drug was designed for women who test positive for BRCA gene mutations. There are about 2,000 of these cases every year in the United States. Under this premise, pharmaceutical advertisement may lure doctors and scare patients into "preventing" ovarian cancer in women who test positive for BRCA gene mutation predisposition. If they have these genes, then they may be coerced or scared into lifetime "preventive" doses of the new ovarian cancer drug. The drug could be marketed according to its clinical trials that show an 83 percent reduction in the risk of disease progression. The method of marketing might sell over quite well, victimizing those who don't question authority, fooling women into using pills for cancer prevention.
FDA questions "the reliability of the estimation of treatment effect"
What the FDA is concerned about is how AstraZeneca conducted its data analysis. The FDA review said there is some uncertainty about the validity of the results, showing how AstraZeneca collected some of the data using archived blood samples. The FDA review formally questioned "the reliability of the estimation of treatment effect."
The review went on to say that the data suggests that most patients may experience some progression-free survival, but that benefit came from a control arm that performed unusually poorly. The review said that there was no difference between the two treatment arms and their overall survival rate.