An ounce of prevention is worth of pound of cure

So the FDA has acted (the ounce). Yes they work slowly but personally I prefer they do that and not rush drugs through the approval process. (Something about deadly

But I digress. Because of that evil man who jacked up the price of a drug because he could and didn't care about the patients, the FDA has moved to see if they can expedite reviews of certain generic drugs (the pound).

"The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold."

I like this idea. A lot. Since a generic is essentially the same (but not quite exactly) of existing patented medications, the approval process is much easier than for brand new drugs (or so I believe). The problem is the agency has a backlog of generic medication applications. So now they will see if they can speed some up.

The more generics available, the better. This makes me happy. 

Another 'Breakthrough'

There is another cancer breakthrough that could lead to 'new treatments'. That would be nice to see. This one claims to have found a cancer mutation weakness that could be identified. And if it could be identified then it could be isolated and targeted. Then it could be stopped or 'cut off' and cancer could potentially be stopped. 

It sounds great on paper. And it might work out in the future. After a few years of research followed by five to seven years of testing. So in a decade this might make a difference to patients.

I am getting tired of this. New medical research is always taking place. But it takes so long to actually make a difference to patients. 

This is actually stressful to the patients who are waiting for treatment and a new medication to save them.

Here's the problem. The media now announces every new medical breakthrough as it is discovered which may or may not actually lead to a new treatment option in a decade or so. With the internet and newer technology the news is spread far and wide. This reaches all the patients and the families who are waiting for the treatments. 

Then as the drug development process starts, patients follow this information. And as drugs go through clinical trials, patients start lobbying the FDA to release drugs early and rush them through clinical trials. Which is not a great idea. 

Think about all those drugs that are recalled by the FDA after additional research finds out that they are harmful. 

But I digress. I hope this 'breakthrough' will lead to new treatments, but I am not holding my breath.

Traveling for cancer treatment

Yesterday while packing wasting time I was watching the local news. It included a story about a first grade teacher who has cancer and needs to go overseas for treatment. She has some kind of liver cancer and has run out of treatment options. In the video she says she is going to Germany for PRRT treatment which costs $100,000. As it is not yet FDA approved, she must pay out of pocket for it.

I was intrigued so I did a little research. The treatment she needs is PRRT or Peptide Receptor Radionuclide Therapy and is for people who have run out of treatment options with certain cancers. Sounds reasonable.

And of course I have a 'but' to go alone with this. The first article I found on it said there is a Level 3 Clinical Trial going on for it in the US and in certain parts of Europe. Then I went on clinicaltrials.gov and found more trials for it in the US, including ones for gastrointestinal tumors and lymphomas and more. I realize that to be eligible for a clinical trial you need to meet certain criteria. So maybe the teacher doesn't meet the requirements for one of the trials.

But if she can participate in a clinical trial, why does she need to pay for treatment? Wouldn't that make more sense than raising money herself (and through her students and other people she knows)?

I am not a big proponent of traveling overseas for treatment that does not yet have FDA approval. (Do you remember the people who went to Mexico for laetrile treatment in the 1970s?) Yes there is the thought that if you are told there are no more treatment options for you wouldn't you want to try anything? But maybe exploring more local options might be a good start.

I could be showing my cynical side again....

Okay, so what am I supposed to do?

The FDA issued a warning the other day about NSAIDs. They strengthened their earlier warnings on NSAIDs saying they can increase the risk of heart attacks or strokes. I've been on a prescription NSAID for about 4 years. Should I be concerned?

The official warning from the FDA says:

"Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech."

 But I think anyone, whether they take NSAIDs or not, should seek medical attention if they experience those symptoms. Not helpful. Thanks.

The reason I am on NSAIDs for so long is my back. I take them for their anti-inflammatory properties to help with inflammation around my disobedient (pain causing) disks in my spine. I probably have inflammation in other areas as well.

I am not due to go back to my back pain doctor until September. But I will make a little note to ask about them. I am all for getting off any prescription I can. But in the meantime, I'll be on the look out for those symptoms....

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.

The FDA isn't always the bad guy.

We like to think of all the alphabet government agencies as the bad guys. They are the big brother that is overlooking everything we do, think, eat, wear, breathe, etc. But maybe this time the FDA is not the bad guy.

There is a massive problem with shortages of oncology and anesthesiology drugs in the US. Most of them are related to manufacturing problems when they are shut down for failed FDA inspections. Others have tried to claim that the FDA doesn't concern themselves with potential shortages when they cite manufacturers but that is not the case. The FDA tries to work with the manufacturers to prevent shortages and tries to get substitute drugs that are manufactured to US specifications overseas.

So where does the problem lie? In an aging manufacturing infrastructure. Hmmm.... so the same people that charge upwards of $10K per dose cant keep their manufacturing facilities up to par? I fail to sympathize here. They are supposed to be saving lives not killing people with defective drugs.

Look out - change ahead!

First - mental note to self - it may look like water on the road but it could be ice, which is slippery and will cause you to fall on your butt and cause bruises later on.

We have change ahead and of course there are protests - even though the changes should prove good in the long term. The FDA wants to change the way medical devices are approved. The current system was started in 1976. Times have changed since then. Any system based on information that is 35 years old probably does need a tune/upgrade/replacement. Think of it this way, if your kitchen was 35 years old with no upgrades in the meantime, you might need some new appliances and a coat of paint to say.

But of course the big drug companies are protesting the change. Their lobbying group said: 'they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.'

Of course they say that because they have to change and spend money to adapt their business policies. But one of the bigger problems with the 1976 system is there is a loophole that allows the approval of some items that slip through the process.


'The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.'

So if a new device is slipped through because it is similar to products already on the market, but if device A went through the approval process and 25 years later and 25 new models later, how similar is the 25th generation product to the original device A? Your IBM selectric typewriter was approved in 1976 and now you are typing on your iPhone. What's the difference?

I see nothing wrong with change. Change is inevitable. We cannot stay the same and expect the word to stay the same. Technology has changed everything as well.