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The Bureaucracy of Lung Cancer: Are Approval Delays Costing Lives?

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Published on September 8, 2015

Are lives being lost due to cancer bureaucracy? While government agencies seek to ensure safety of clinical trials, researchers say bureaucratic delays and mountains of paperwork are costing many more lives than the ones that are saved. Lung cancer experts, including Dr. David Stewart, sounded off on this at the World Conference on Lung Cancer in Denver, and Patient Power’s Andrew Schorr was there.

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Transcript | The Bureaucracy of Lung Cancer: Are Approval Delays Costing Lives?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That's how you’ll get care that's most appropriate for you.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

Andrew Schorr on location in Denver, Colorado at the World Conference on Lung Cancer. I tell you some of the leading experts here are frustrated. They’re frustrated with all the bureaucracy about clinical trials in lung cancer, let’s face it, a very lethal condition. They say it takes too long. There’s too much paperwork. Thousands and thousands of lives have been lost because of the delays. We heard a lot about that at a press conference here in Denver.

Dr. Stewart:

Regulation is absolutely essential. It is essential. We cannot do away with it. With the knowledge I use, we need the equipment that’s the equivalent of the autobahn in Germany. Unlimited speed limits but one of the lowest traffic fatality rates in Europe because of the fact that they’ve got smart regulation—not too much and not too little—but smart regulation.  Right now, our regulation is not smart. And there’s a massive series of speed bumps. If you went out on the highway here and put a speed bump every 1/10th of a mile, you know what’s going to happen? The traffic’s going to come to a standstill, and that’s what’s happening. All these multiple small speed bumps, if you fix any one of them, it’s not going to fix the problem. 

What we need to do is just make sure to take the speed of approval and the expense of approval and make that our top priority for lethal diseases. I’ve got no problem with the regulations as they are for the treatment of acne or high blood pressure or even for adjuvant treatment of breast cancer where there’s a high cure rate. But for people with a 100 percent lethal disease we need to completely change the way that we apply the approval and how we apply them to get these drugs to patients much faster and much cheaper. 

The costs for these from the market is through the roof, and that’s driven largely by the cost of doing the research. And so we’re going to bankrupt ourselves, either we’re going to put in cost controls, and nobody’s going to develop the drug because of the cost controls. Or we have to tackle this problem, and we have to get the cost of the research way down and at the same time make it much more efficient. 

Andrew Schorr:

In the meantime, people are dying.

Dr. Stewart:

Absolutely. I mean if I put in a protocol into the IRB, they will send it back and say, change these three words in the protocol, because the patient might not understand it. So they don’t take a month or two months to get it approved. So patients are dying while wording is perfected. The priorities are all wrong. The priorities are just wrong.

Andrew Schorr:

So write your Congressman or your legislator wherever you may be and say that we need to approve things faster, clinical trial designs, and, of course, get drugs approved so they can help save my life and my loved one’s life. 

On location in Denver, Colorado, I’m Andrew Schorr. Remember, knowledge can be the best medicine of all.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.