Dosage changes

Last year or maybe earlier this year, I have chemobrain and I can't remember exactly when, the oncologists in the US got together for a big event which they called a conference. They did get a lot of work done and came up with some new recommendations for changes in cancer treatments. One of these was to state that it is better for women with a breast cancer diagnosis to be on Tamoxifen, Femara, or the other AIs for ten years instead of five.

Well someone forgot to tell the FDA this so they FDA says five years and the oncologists all say ten years. But the FDA makes the rules so the oncologists have to bring it up to speed. One woman in Michigan has started an awareness effort to this end.

But it does raise an interesting thought. When a drug is initially approved by the FDA, the approval includes dose sizes, length of treatment, etc. Then additional research is done, whether it is on children instead of adults, or for a different ailment, the FDA needs to change its guidelines so an  amended approval is needed. I am sure there is some fancy process for this involving expensive lawyers drawing up paperwork as well as lots of research time but I have no idea what it is.

In this case, the oncologists came up with their new recommendations and now some one has to get the FDA up to speed so we can all be less confused.

Exclusivity of clinical trials

I think the concept of clinical trials are great. I have tried to get into several and have always been told that I did not meet their criteria so I wasn't eligible. Very frustrating.

I understand why pharmaceutical companies are insistent on their strict criteria. They want to make sure if they take a group of similar people they can monitor for effectiveness and adverse effects. If they have a very diverse group, it can be much harder to determine the results.

The FDA is interested in changing this policy and forcing companies to include patients with chronic conditions (possibly me?) in clinical trials.

"Pharmaceutical companies routinely exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates, but, as a result, the studies don’t provide a glimpse of the treatment’s “real world” effect.

To counter this, the FDA recently issued a memo to its new drug reviewers asking them to work with drug manufacturers to include a broader population in trials more regularly.


“The whole point of this is that if there really are differences in response — either favorable or unfavorable — among subsets of the population, what clinicians need is to know about it, so they can either watch for them or use a different drug,” Bob Temple, MD, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, told reporters Friday. “This adds to the information available.”"

I find it to be a shame that so few Americans participate in clinical trials but then so many are told that they are eligible. With my medical history, no one ever wants to include me. I for one am looking forward to this change.

The transfat debacle

The FDA wants to get rid of transfats because they are bad for us Americans and cause all sorts of problems. I don't have a problem with that because they are in things that either I don't eat or can be easily made without them.

I used to use margarine but decided it had too many ingredients. Now I use unsalted butter. It has one ingredient - cream. I don't buy frozen pizza, microwave popcorn, coffee creamer and all sorts of lovely prefab foods including baked goods. It helps things retain their shape and improves shelf life. I prefer things that are fresh with few ingredients.

McDonalds has gotten rid of transfats so you can safely eat their fries. Dunkin Donuts seems to have removed transfats from their donuts. I am sure other chains have done the same.

Skip the frozen pizza - either order it delivered or make your own from scratch or use the premade crust available at the deli. Microwave popcorn - a/k/a chemical popcorn - can easily be replaced by a little brown paper bag that you used to use to bring lunch to school and 1/4 cup of kernels. Fold the bag sealed and put in the microwave for 3-4 minutes. Voila its chemical free. Melt some butter separately if you really want.

My absolute favorite, horrible for me meal that I eat rarely is fried clams and scallops with onion rings and fries - my husband and I split a plate - and we get it at a place which fries everything in lard. Lard doesn't have transfats either.

My gut (haha) tell me that the place that would take the biggest hit if transfats were removed would be the frozen prepared food section of the grocery, the premade baked goods in the grocery, microwave popcorn, and the fancy creamers that go into coffee. Could we live without these? Probably fairly easily.

I am with the FDA on this one.

Dosage changes

Last year or maybe earlier this year, I have chemobrain and I can't remember exactly when, the oncologists in the US got together for a big event which they called a conference. They did get a lot of work done and came up with some new recommendations for changes in cancer treatments. One of these was to state that it is better for women with a breast cancer diagnosis to be on Tamoxifen, Femara, or the other AIs for ten years instead of five.

Well someone forgot to tell the FDA this so they FDA says five years and the oncologists all say ten years. But the FDA makes the rules so the oncologists have to bring it up to speed. One woman in Michigan has started an awareness effort to this end.

But it does raise an interesting thought. When a drug is initially approved by the FDA, the approval includes dose sizes, length of treatment, etc. Then additional research is done, whether it is on children instead of adults, or for a different ailment, the FDA needs to change its guidelines so an  amended approval is needed. I am sure there is some fancy process for this involving expensive lawyers drawing up paperwork as well as lots of research time but I have no idea what it is.

In this case, the oncologists came up with their new recommendations and now some one has to get the FDA up to speed so we can all be less confused.