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Sunday, September 16, 2012

Yes on TEST Act (H.R. 6272) Clinical Trial Reform

 Please support H.R. 6272

By Roxanne Cousins

September is National Ovarian Cancer Awareness Month!!! This is a month dedicated to raising awareness, money, hope, and telling the cold hard truth about what we who are fighting this disease are up against. I am an ovarian cancer survivor who was diagnosed Stage IIIC in May 2010. I was just shy of 38 at diagnosis, married to a wonderful husband with whom I had a 10 year old son and not in the least bit prepared for a cancer diagnosis! After about 7 months of a remission, I had a recurrence and recently finished treatment but am probably looking at a long line of continued chemotherapy ahead of me, if I'm lucky. Since it is widely stated, even among some oncologists, that there has been no change in the death rate with regard to ovarian cancer in over 30 years, I am looking at a fairly uncertain future even though I am only 40 years old. Despite all this, I do feel that I have a positive attitude. I believe that there is a cure and that it will be found but I also feel that the current system is going to make that pretty difficult business. 

Like many cancer patients, researching the latest clinical trials and possible treatment options is something I do every day. What I have suspected and what I am beginning to understand to be a certainty now is that there are drugs out there that have been proven to help cancer survivors yet are not getting FDA approval and, despite positive results in clinical trials, the drugs become unavailable. Let me repeat: Good drugs that have been shown to be effective in fighting ovarian cancer are purposely made unavailable. 

Recently, I was in the running for a vaccine trial (KLH + OPT-821) in Oklahoma City and met a wonderful gyn/onc there. She was mentioning to me how I may, at some point, want to look into a PARP trial (a class of drugs that has gotten a lot of positive reviews within gynecological oncology. She went on to say that she felt Olaparib (one specific PARP) was a very good drug, probably better than Veliparib (a newer one that has come out and is in trials), and that some people had great responses etc. but that it did not get FDA approval and now is going to be very difficult to get. She said it would likely start showing up in Europe in trials there and then maybe someday they'd bring it back over here. 

I did go ahead and ask my local oncologist if he could get it off label and it was confirmed that no, since it is not FDA approved, they can't get it for me and while there are a few trials still out there on it I guess after they're closed, that will be it. 

A fellow survivor I am in touch with recently told me that she was able to get the PARP drug Olaparib through a clinical trial some time ago. She said that the oncologist at this site, who is heavily involved in clinical trials, told her that the problem was with "drug company economics" and, while the drug worked well for ovarian cancer patients and in a number of breast cancer patients with a particular type of mutation, further trials by the pharmaceutical companies to see if it would work with a larger group of breast cancer patients didn't go as well. According to this oncologist, the "universe" of those patients who could benefit wasn't as large as they would have liked, and therefore not worth their time so it was essentially dropped. There is another drug called Farletuzumab that worked very well for some ovarian cancer survivors - I believe it has met with the same fate. Successful in trials, yet unavailable. There are other I can only wonder about.

One major problem that is glaringly obvious in its need to be fixed is the opaque nature of the clinical trial system. This broken system ensures that information needed by the public as well as researchers and others who are looking for a cure is not open for sharing, nor is it added to the general base of existing knowledge for a particular disease. This is the opposite of what should be happening and what most people think is happening with information gleaned from clinical trials. In trials that have already been completed on the government website where trials are registered, the "Results" tab is almost always blank, and one has to ask around, talk to people in the know, and put things together. The Transparency for Clinical Trials Act (or the TEST Act, H.R. 6272), was recently introduced in Congress by Rep Ed Markey (D-MA) and addresses this issue of purposely-withheld information by drug companies but, sadly, is projected to have only a 3% chance of passing. This will not solve everything, but it’ll be a heck of a lot harder for drug companies to deny patients of drugs that are showing positive results, in black and white for all the world to see. 
Additionally, Donald Light and Joel Lexchin point out that:

"Taxpayers pay for most research costs, and many clinical trials as well. In 2000, for example, industry spent 18% of its $13 billion for R&D on basic research, or $2.3 billion in gross costs (National Science Foundation 2003). All of that money was subsidized by taxpayers through deductions and tax credits. Taxpayers also paid for all $18 billion in NIH funds, as well as for R&D funds in the Department of Defense and other public budgets. Most of that money went for basic research to discover breakthrough drugs, and public money also supports more than 5000 clinical trials (Bassand, Martin, Ryden et al. 2002). Taxpayer contributions are similar in more recent years, only larger."

So the public subsidizes these trials, but it is with the implicit understanding that the pharmaceutical industry is diligently working toward a cure, learning new information through research, and adding that new information to the existing body of knowledge, NOT hoarding information and choosing what to do with the data based on monetary factors alone. So, after all the time and expense involved in these clinical trials, a drug that was extremely promising and had many successes with ovarian cancer as well as some breast cancer patients is now essentially unavailable. I do not feel I am hyperbolizing when I say this is outrageous, on many levels. The women who have participated in these trials (unless it is through the NIH) get to and from the trial site on their own dime and it is often very expensive; even the cost of transportation for these valuable trial subjects is not absorbed by the pharmaceutical companies. The tacit understanding of these women (many of them desperate and in end stages) is that even if the trial will not help them, they are giving of themselves to help advance the body of knowledge that exists and hopefully what is learned will lead to a cure for their fellow survivors. The current way of doing business is a slap in the face to these women, and a breach (I feel sure) of their understanding of what might be done with the information gathered, which is to use it only in a way that benefits the company.

Why in the world is a drug that has been effective for so many go through trials and then end up becoming not available? I feel quite sure that the story of Olaparib is not unusual, as it seems that this is the way the business model is set up. Drug companies' use of countless human guinea pigs and taxpayer dollars to find successful treatments for cancer or other diseases should not be allowed to make these drugs unavailable; this is patently unethical. 

With 1 out of 3 women and 1 out of 2 men facing a diagnosis of cancer at some time in their lives, these are issues we should all be aware of. We owe it to ourselves and those we love to get involved and spread the word about what is going on. The issues laid out here do not apply to only women with ovarian cancer, but to anyone who is affected by cancer or who simply cares about the cause. Now is the time to pledge to break down barriers - and I’m talking about ANYTHING that gets in the way – to The Cure! We cannot allow ourselves to sit back comfortably as women continue to die while treatments are being withheld and pharmaceutical companies continue with business as usual. A survivor friend did some research on the history of the FDA and found that the biggest changes occurred when there was public outcry, so if that’s what it takes…

This September, let’s do more than wear our Teal t-shirts and ribbons. Let’s demand more than what we are currently given, and let’s channel the loving and generous sentiment that characterize the people of this nation, and encourage them to support us where it really matters and demand change. Let’s no longer allow the false narrative that pharmaceutical companies are doing all they can and as fast at they can to find cures as that is precisely what is perpetuating the system. 

Write your Congressmen and women and simply demand that they support cancer patients by voting for the TEST Act (H.R. 6272) to reform the clinical trial system, and to use their legislative power to push for more information sharing, more innovative research, and more access to potentially helpful drugs that have already been identified. You can find your representative using the following link:

Also, please call or write OCNA at 

and ask them to not only support the TEST Act, but to make us aware of these types of issues in the future and work toward breaking any and all barriers that prevent us from access to treatments that we desperately need! 

Here’s to progress and to people power!!


Light, D., J. Lexchin. 2004. Will Lower Drug Prices Jeopardize Drug Research? A Policy Fact Sheet. The American Journal of Bioethics 4(1):W1-W4.

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