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Subscribe to RSSThe clinical trial known as I-SPY 2 is an attempt to shorten the approval process for breast cancer drugs. The trial being conducted at 20 medical centers across the country. NBC's Robert Bazell has more.
From the time a promising new cancer drug is discovered to when it is proven to work typically takes 10 to 15 years and can cost from $1 to $2 billion. Within the pharmaceutical and biotechnology industries this span of time is called the “valley of death,” a term that has both metaphorical and literal meaning.
The clinical trial known as ISPY-2 is an attempt to shorten this approval process for breast cancer drugs. It is run by the Foundation for the National Institutes of Health and supported in large part by the Safeway’s food chain’s charitable foundation. The trial is being conducted at 20 medical centers across the country.
Chemotherapy drugs (including hormone treatments) are normally used against cancer in one of various circumstances. One is for cancer that has spread after the initial surgery and radiation, a situation that doctors call “treatable but not curable” and want to avoid if at all possible. Another is to try to prevent recurrences in cancers that appear to have a significant risk for coming back. If that prevention succeeds, the patient is cured. Usually doctors give this chemotherapy as so-called adjuvant treatment in the weeks and months following the initial surgery and radiation.
The key to ISPY-2 (all clinical trials these days are known by acronyms) is an approach known as neo-adjuvant chemotherapy. The patient gets the chemo-hormone combination before the surgery. Using MRI scans, the researchers can watch in real time to see if a drug combination is shrinking a tumor. Sometimes it shrinks so much that there is little to find when it comes time for the surgery.
This procedure allows for quick comparison of an experimental drug combination with the standard care. In the future the researchers will be able to look for molecules in the tumors (so called bio-markers) that will help determine which combination will be the best. The hope is that the trial will more quickly identify drugs to help thousands of women. Most experts see this sort of “personalized medicine” playing a big role in the future.
But ISPY-2 requires a leap of faith. Does chemo before surgery do as much good as chemo afterward? Absolutely, says Dr. Laura Esserman of the University of California, San Francisco, who heads the effort.
“The truth of the matter," she says, “is if you're going to die of breast cancer you're not going to die of the tumor that's in your breast. You're going to die because the tumor has spread outside the breast and those cells can take up residence someplace else in your body. The only way you're going to save that person is to make sure that you eradicate all of those cells wherever they may be and the sooner you start with the whole body treatment the better off you’re going to be.”
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YEP!
God forbid these nasty, mean, fat-cat, Big-Pharma companies make a profit. According to the "level playing field" lemmings the corporations should just surrender their profits and absorb their liabilities.
Remember, for every 1,000 compounds that are identified by a company, only about 30 show promising results. And for every 30 compounds that show promise, three get past the first round of clinical trials and finally, only one hits the market. Sometimes compounds are to be dropped off during regulatory approval process. Thus, to introduce one new drug, a company needs to start with many thousands of compounds.
And of course in 5-10 years after the shortened approval time drugs are found to have some type of side-effect that wasn't caught during the ISPY "with my little eye"-2 trials you know the lemmings and lawyers will be screaming from the mountain tops to sue the evil drug companies.
Ah, the American way.
Freedom,
I don't think anyone will argue that drug companies should not make a profit. They invest huge amounts of money to bring drugs to market with significant time invested and little time left over for patent protection.
What people are concerned with is price gouging in the medical industry in general. If you daughter needed a life-saving surgery and they said, "Freedom, it'll cost you $50,000 cash to have this done", what would you do? Would you pay the $50k? How would you feel if two weeks later you found out the same surgery really only costs $5,000 but they charge that much because you had no other choice at the time?
I think what we're talking about is reasonable profit when it comes to healthcare because there is sometimes no other alternative except pain, suffering or death. Is it fair that companies can gouge people because their choices are limited? This is one situation where supply and demand need to be regulated to make sure consumers who have no other choice don't get raped.
For the time factor, if it's life or death, I bet people would be willing to gamble on the side effects due to less time for studies. I would also take the chance knowing there would be unknowns and I would waive my right to sue except for matters that were previously known but not disclosed.
This makes sense!
This stupidity goes against everything we have learned about cancer, and everything stated in medical literature. The genetic makeup of a primary tumor is vastly different than the micrometastatic cells. Therefore, the therapies which may work on a primary tumor, seldom work on metastatic lesions. This is cancer 101. These women are being experimented on by complete idiots.
I agree, it goes against a lot in the medical literature but new discoveries frequently do. Like the Australian doctors that discovered that stomach ulcers are often due to a bacterial infection. No one believed them but they were right. I know that cancer is way more complex and while it is often true that metastatic lesions tend to have cells that are not genetically identical to the primary these doctors may be scratching the surface of a new way to treat breast cancer. In the past there has been similar work that has failed. The patient's tumor cells were exposed to various chemotherapy drugs to see if they died. The problems were numerous, including the fact that the researchers could not tell if a colony of cancer cells was already dying before it was exposed to a drug, and the levels of the drugs that the colonies were exposed to were often way higher than could be achieved in a living patient (the dose would have been lethal). However, with new technology maybe this type of research will eventually work. Then the only problem will be whether or not a person is rich enough to afford it.