Drugs for the Dying

I sympathize with those patients who would like to have access to unregistered drugs but have reservations. Skipping the argument that this would reduce motivation to participate in clinical trials, there is another issue to consider. Part of the reason for clinical trials is to look for signals of adverse events. If a non-study patient experiences an adverse event, how should that be evaluated in terms of assessing the overall risk/benefit profile of the drug? Would adverse events in terminal patients discourage earlier stage patients from taking the drug? How would the FDA be able to use the info to determine if the event was drug related, disease stage related, both or neither? I think it is difficult enough to evaluate safety and efficacy of drugs without complicating thing.

Sent by Stacy R | 3:10 PM | 7-30-2007

Mr. Pollack says we are making some progress on the military front but almost all agree that the only solutions are political, not military. A recent article in the Chrisitan Science Monitor by Sam Dagher suggested that the Iraqi government is close to collapse. Pollack totally ignored the issue of how he got it so wrong prior to the war. Why should we believe him now?

Sent by Gregorio Browne | 3:12 PM | 7-30-2007

I live in Oregon which has the Death With Dignity law. This allows the terminally ill to receive, from a Dr, a lethal dose of medication and I support this law. But, it seems absurd to me that people can receive pharmaceuticals which will kill them but not drugs in clinical trail that might help them.

Sent by Mark | 3:24 PM | 7-30-2007

While it may seem to be compassionate to give unproved medicine, it is disruptive to the science that is involved in the discovery of new medicines. Making this a political issue is not helpful.

Sent by Duff Green | 3:34 PM | 7-30-2007

For a drug to even begin a trial it must be approved by the FDA. After phase 1,2 ... safety has been determined ...drugs for patients at end of life should be given access after stage 2 is completed ...not when FDA employees and those with a known conflict of interest reposition stock portfolios to give it the stamp of approval. Why do so many people lie today it is like they lie even when they don't have to lie.

Sent by Lois lane | 3:35 PM | 7-30-2007

If someone if dying -- I doubt any new drug will be best for her or him. It would be best for that person and their loved ones to accept death and access Hospice services. Death is not something to be avoided.

Sent by Georgean Johnson-Coffey | 3:42 PM | 7-30-2007

Did I hear Dr. Miller say the courts tend to view compassionate use of unproven drugs exactly like physician-assisted suicide? Is it assumed, then, that in taking an unproven drug, an individual might in fact be committing suicide? If so, this issue won't be resolve for a very long time.

Sent by Judy Lane | 3:47 PM | 7-30-2007

The denial by the FDA of therapies for the terminally ill is completely irrational.

They are incapable of using ordinary common sense to decide a risk vs. benefit analysis that makes sense when considering those patients that have no other hope.

Litigation is the oldest form of advocacy. When the executive and legislative branches of government will not help then its time for the judicial branch to act.

My best to Mr. Burroughs.

Sent by Kerry M. Donahue, counsel for CareToLive | 3:56 PM | 7-30-2007

I just missed the calling for this topic, but I would like to add that the referring physicians of patients with terminal illnesses should know the admission criteria for the clinical trials before they send pt's to these facilities. Our daughter in law was finally admitted to a clinical trial in Chicago @ Rush Presbyterian for an experimental drug for the tx of her metastized breast cancer. After getting her there we found she didn't meet the admission criteria for the study and was turned away. She died two weeks later. Had the referring MD @ IN University Medical Ctr. alerted us to the admission criteria for this trial we would not have made the exhausting trip.

Sent by Cheryl Stark | 3:56 PM | 7-30-2007

I was on a drug for compassionate use... it saved my life until I was able to have a heart/ lung transplant.It was simple to get approval thankfully,and it really is not as simple as policy vesus compassion.
it not as clean cut as policymakers would like to have it. People at that stage of their life should be able to make the decision for themselves.
which is very different than say the FDA approving a medication for a relatively minor illness such as restless leg syndrome ( for example)

Sent by Liz DeVivo | 3:59 PM | 7-30-2007

In response to Mr. Green: since when under the current Bush administration has the FDA been nonpolical?

Sent by Don anderson | 4:14 PM | 7-30-2007

FDA DOES, in fact, have mechanisms to make investigational drugs available to people with serious illnesses who have exhausted approved drug options, and cannot participate in clinical trials. Mr. Burrough's point seems to be that his daughter would be alive today if she'd been allowed access to an investigational drug. But the company, and not FDA denied access because it would have negatively impacted their ability to conduct the trials necessary to see if the drug really worked, how well it worked, at what dose, and with what side effects. Cancer therapies often don't work for many patients even after they are approved. But shifting the incentive to sell (to very wealthy patients) the small amounts of investigational drugs available, rather than studying them, simply denies greater numbers of future patients access to drugs with known side effects, predictable dose requirements, and third party reimbursement.

In the long run, it's a very short sighted idea.

Sent by Clark Kentman | 4:55 PM | 7-30-2007

The War on Cancer has hit a stalemate. The percentage of Americans dying from cancer is still the same as it was in 1950 and 1970. Cancer will soon pass heart disease as the leading cause of death in the US. So if an anticancer agent shows reasonable safety and efficacy approve it. Terminally ill patients, in consultation with their physicians, should be entitled to elect to assume a higher level of risk.

Sent by Brian Keane | 5:25 PM | 7-30-2007

America finally figured out it didn't need the Interstate Commerce Commission, our very first regulatory agency, to decide who owned and operated trucks and over what routes they were to be used. It was dysfunctional and it was disbanded. America is now figuring out that it doesn't need the FDA to decide who owns and operates the human body and what routes are to be used fighting disease. It is dysfunctional and it should be abandoned. You cannot trust an agency receiving a large part of its funding from Big Pharma whose interests are not congruent with cures, but only with profitable palliations. Nor can you trust it not to be swayed by internal and external politics. Its only legitimate function is to opine on the safety of drugs, therapeutics, et. al. It fails. The latest evidence of it's failure is evinced by its treatment of Provenge. I would sooner trust an organization such as Consumer's Union to address that function. The minions of the FDA could then turn their skills to the treatment of patients rather than the prevention of progress, although given their collective track record they should be confined to lancing boils, albeit under close supervision.

As you may be aware, September 16th - 22nd is Prostate Cancer Awareness Week. Please join us September 18th to rally against the FDA's decision regarding Provenge for the treatment of prostate cancer. Every voice counts. You can find out more at http://www.arighttolive.com

Sent by Ming | 1:14 PM | 7-31-2007

Most people here seem not to understand that the drugs that are in question here have been proven safe. In a recent case of Provenge, the drug was deemed safe by a unanimous FDA Advisory Committee vote. It also was deemed substantially efficacious by a 13-4 vote, and two of the dissenters have some very serious conflict of interest and other inappropriate behavior questions hanging over them. Yet the FDA denied this drug to a dying population (30,000 men each year) that has no other options. For the woman lawyer on the show to liken these drugs to those used in assisted suicide is beyond ludicrous.

Read the excellent article in today's WSJ on this subject. Those without access, go to this page and click the link:

http://news.google.com/news?num=100&q=%22cancer+drug+fails%22&um=1&sa=N&tab=wn

The FDA is playing abstract statistical games with peoples' lives. If a drug works in a subset, even when discovered after the fact, it should be approved for that subset, conditional upon further clinical confirmation. That will do the right thing by the patients and it will keep the company running and encourage medical research in general. The current system denies patients, punishes companies, and impedes medical progress.

The FDA is stuck in an absurd statistical despotism. It is an authoritarian agency out of control. It's past time to reign it in. Change will only come when the general population becomes aware and refuses to accept this ongoing travesty of justice.

Those arguing that there is no Constitutional basis for a right to "experimental" drugs (as if these drugs have no track record at all...) may not be mindful of the very reason for that great document, stated in its Preamble, the guarantee of the right to life, liberty, and the pursuit of happiness.

Sent by Paul B | 9:12 AM | 8-2-2007

Never ceases to amaze me the ignorance of some like the ivory tower lawyer(potential life saving medicine is unconstitutional?), FDA/NIH regulator and insensitive oncologist on your fine program who present an endless list of rationalizations of why terminally ill patients should just go away and die already.

Sent by Chuck Bennett, MD | 11:50 AM | 8-2-2007

It seems Frank was cut off prematurely. The law professor was given a disproportionate amount of time. This was not fair or educational. I would appreciate some form of rationalization. Thank you, Chris

Sent by Chris Sefton | 5:26 PM | 8-2-2007

keep up the good work that we love so well.....

Sent by anyone | 5:22 AM | 12-3-2007