The Assertive Cancer Patient

ASCO Stalls, Responds (Sort of)

Here's the e-mail I finally received from ASCO, 10 days after I first e-mailed asking for comment on the Abigail Alliance controversy during the ASCO annual meeting in Chicago.

They didn't respond until I had e-mailed twice, and now the PR person is telling me that she has forwarded my e-mail to the policy folks. We'll see how soon they respond. You can bet that if I were working for the Wall Street Journal, or Newsweek, as I used to, I would have a response within the day!

Hi Jeanne,

I'm sorry no one has gotten back to you yet. I forwarded your email to the policy side of our department and they should be getting back to you today. [Which would have been the 12th; no answer yet] Unfortunately, we did not get your email until we had returned from the Annual Meeting because this email account cannot be checked from a remote location [she's kidding, right? This is the e-mail account for media relations inquiries that is on the ASCO Web site], so I apologize for the delay in responding.

Best,
Kelly

Kelly Powell
ASCO Communications
kelly.powell@asco.org

See also:

Abigail Alliance in the Wall Street Journal

ASCO Is Ignoring Me

@ Jeanne Sather 2008.

Abigail Alliance in the Wall Street Journal

The Abigail Alliance has a really good contributed editorial in the Wall Street Journal.

It was written by Steven Walker (who had responded to my questions about the ASCO controversy, see below) and Ronald Trowbridge.

The piece uses Senator Kennedy's brain cancer diagnosis as a news hook, a strategy that I am opposed to, but as a former mainstream journalist I know how essential that news hook is.

It says, in part:

"Most people receiving a terminal cancer diagnosis die before the most promising treatments in the pipeline reach them. Why? Because those tragic events occur on the wrong side of the magical moment when someone at the FDA puts an approval letter on a fax machine declaring the drug they needed – and never got – is 'safe and effective.'"

Read the entire story:

How the Senate Can Help Ted Kennedy

More on this topic:

Censorship Controversy at ASCO

ASCO Controversy: The Abigail Alliance Responds

Boycott Clinical Trials?

ASCO Is Ignoring Me

The ASCO Notebooks

@ Jeanne Sather 2008.

Pay Cancer Patients to Take Part in Clinical Trials

Several years ago, a major clinical trial to compare prostate cancer treatments had to be canceled because not enough men with the disease enrolled in the study.

The oncologist who told me about this said that the reason was men refused to be randomized between the radiation therapy and surgery arms of the trial. (An "arm" is a group.)

I'm not a scientist, but I fail to see why the researchers couldn't have done a "case-controlled" study, where they matched each man who chose surgery with a man of similar age, general health, and race (or whatever other characteristics they were interested in) who chose radiation therapy.

Guinea Pig Phobia
For various reasons, cancer patient participation in clinical trials is low--only about 5 percent of adult cancer patients. This is a problem for researchers and drug companies, because all new treatments must be tested in human subjects before they can be approved.

Now, at the ASCO meeting in Chicago, I learned that there is pressure on the FDA to change the rules for providing new cancer treatments to patients "off-protocol"--that is, outside of clinical trials.

I am opposed to any change that makes it more difficult for doctors to prescribe treatments off-protocol.

There are many reasons a cancer patient might not be able to enroll in a clinical trial. In addition, if drug companies and other researchers are having problems finding enough cancer patients to take part in their trials, they need to improve patient recruitment--not tighten access to drugs off-protocol.

One way to improve recruitment would be to PAY CANCER PATIENTS TO TAKE PART.

Now, researchers aren't going to want to do this, because it will increase the cost of the trials, but think about it--cancer patients who take part in clinical trials are risking their lives. They are also risking their quality of life during what could be the last months of their lives.

Why shouldn't they be compensated for the risks they are taking?

You can also expect researchers to say that paying subjects would skew the results, but I disagree. People are already being paid to take part in all kinds of scientific research, most of it much less risky that cancer clinical trials.

For example:

** Novum Pharmaceutical Research Services, in Las Vegas, advertised "for healthy individuals to participate in one of our paid research studies to earn up to $600.00." Novum Pharmaceutical describes itself as "one of the world's largest research companies in the testing of generic medications."

** Novum ran a second ad in the same issue of the Las Vegas "Employment Guide" seeking women between the ages of 18 and 50 to stay at its facility for two nights and apply various "investigational creams and ointments to your arms and make assessments." For this, the fee is $220.

Not research, but still giving up valuable bodily fluids:

** A company called LifeSera is advertising for paid plasma donors, who it said could "earn extra money twice a week." And more if they qualified for a "specialty program."

And while we are on the subject of money, do you know any cancer patients who are not having financial difficulties? I know maybe one, and she works for Microsoft.

@ Jeanne Sather 2008.

Boycott Clinical Trials?

Here's a question: Should we consider boycotting clinical trials until the FDA sees sense on the off-protocol issue?

Don't know what I'm talking about? Read these two posts, and then post a comment below and tell me what you think.

Censorship Controversy at ASCO

ASCO Controversy: The Abigail Alliance Responds

Remember, they (drug companies and cancer researchers) can't do it without us (cancer patient guinea pigs). Because the law says that no new cancer treatment can be used until it's tested on human subjects. Again, that's us.

The public has been very slow to get this, and participation rates in clinical trials are very low. (See: Soapbox No. 4: NIMBY to the Max) In general, I support participation in clinical trials, and I've taken part myself several times over the almost 10 years I've been living with cancer.

But now I'm beginning to wonder. After all, the drug companies profit hugely when they have a hit, like Genentech's Avastin and Herceptin. I think cancer patients should be PAID for their participation in clinical trials--after all, they are risking their lives.

But for now, let's keep the issue simple. And the issue right now is whether or not the FDA will tighten the rules to make it harder for oncologists to give their cancer patients new drugs off-protocol, which means outside of a clinical trial. Some 100,000 U.S. cancer patients are now receiving drugs off-protocol.

I think I'm one of them, actually. My treatment is a made-for-me combination of drugs put together by my oncologists. And it's working.

@ Jeanne Sather 2008.

Soapbox No. 4: NIMBY to the Max

Clinical trials are essential to cancer research. Without clinical trials, new drugs and treatments cannot be approved. No matter how promising a new treatment looks when tested with lab animals, it cannot be used to treat people until it has been carefully evaluated through the several phases of a clinical trial.

Most Americans understand this, and the majority of people surveyed on this issue say that no drugs should be given to people until they have been thoroughly tested for safety and effectiveness in human subjects.

But here's the kicker: The majority of Americans, something like 80 percent, say drugs must be tested on humans, but only about 4 or 5 percent of adult cancer patients actually volunteer to take part in clinical trials themselves.

This is NIMBY-ism on an incredible scale. What do these people (who want the newest and best cancer treatments and want them yesterday) think researchers are going to do, test new drugs on people in the Third World? (Sadly, the answer is probably yes.)

Those of you who don't have cancer aren't off the hook, either. Sign up for a prevention trial, and do your part for humankind.

Having said this, the choice to participate in a clinical trial can be a difficult one.

In addition, I think cancer patients who participate in clinical trials should be given a stipend to compensate them for their time and for the risks they are taking. I'll be writing more on this topic.

@ Jeanne Sather 2006