Clearing My Head

Today’s the day to bring up those isolated thoughts roaming through my mind.

But first: happy birthday to Lara, she of the bunnies {the one I introduced on this blog – Temperance – now has a buddy, Seely} and one of the five lovely daughters in this blended family.  It’s quite a coincidence how their ages step: each one is just about a year older (or younger, depending upon how you look at it) than the others.  May you have many more healthy, happy, fun birthdays Lara.

Questions have been raised about pertussis (whooping cough) which I hope to have answered for you a.s.a.p.  Parts of Texas and Seattle, Wa., already have epidemics so I’m in contact with the CDC experts awaiting an explanation as to why CKDers need to be extra careful about this disease – if, indeed, we do. Thank you to Laura for bringing up the question.

Some of you have been asking for a way to check on the interactions of any medications you may be taking. After a bit of researching, I’ve found just such a function at: http://healthtools.aarp.org/health-encyclopedia?cmp=NLC-HealthEng-CTRL-82510-LONG-ENCYC.  Look on the upper right side of the page.  I don’t think this one is terribly medical in its explanation since it is AARP (American Association  of Retired People) rather than a physician’s site.  Let me know how you like it if you decide to give it a shot.

I pulled up this article from last Halloween (hmmm, is the date relevant?) as an example of why I have so many doubts about drugs, drug companies and just what each drug can do despite the fact that we sometimes need the drug.

Controversial Cholesterol Pill Vytorin Shows Promise For Kidney Patients

 by

 October 31, 2011
 
[This is me: the first part of the article refers to a television advertisement demonstrating that your high cholesterol may be caused by genetics, bad habits or a combination of both.]

Remember Grandpa Frank?

Way back in 2008, the ad above ran in heavy rotation on TV during the heyday of Vytorin, a cholesterol-lowering pill that claimed to fight both genetics and bad habits.

Soon after the ad had appeared, oh, say thousands of times across the country, the Food and Drug Administration asked the company to revise the ads with Grandpa Frank and other relatives because the ads didn’t reveal a study showing Vytorin wasn’t any more effective than simvastatin, a generic cholesterol medicine that is one of Vytorin’s components.

Later that year there was more bad news for Vytorin — and fear among patients — when a study suggested Vytorin raises the risk of cancer slightly. Sales fell from a peak of $5 billion a year to $2 billion last year.

None of this caused the FDA to change its view of the safety of Vytorin. The agency even issued a statement in 2009 essentially exonerating Vytorin of the cancer risk.

Now, Merck, the maker of Vytorin, is looking to regain some of the lost sales of the drug by touting its use in people with chronic kidney disease.

A new FDA analysis shows Vytorin lowered the relative risk of heart attacks and strokes by 22 percent among CKD patients in the relatively early stages of disease — before they need dialysis. For those with more severe, later-stage disease, the drop was 6 percent.

The FDA analysis also failed to find any increase in cancer or cancer deaths in the 20,000-plus patient study.

Merck is seeking FDA approval for use of Vytorin in CKD patients of which there are 26 million in the U.S. alone, according to the National Kidney Foundation.

A committee of independent advisers to the FDA will go over the data for and against Vytorin at a meeting Wednesday.

You can read the article at: http://www.npr.org/blogs/health/2011/10/31/141880804/controversial-cholesterol-pill-vytorin-shows-promise-for-kidney-patients?ft=1&f=1027

I’ve got questions:

1. Why is Vytorin, rather than its generic form –  simvastatin – being touted?  Didn’t the article state that this component of Vytorin was just as effective?

2. What happened to the study suggesting that Vytorin raises the risk of cancer slightly?

3. Since I found this on the official FDA site for Vytorin at Drugs.com, why isn’t it mentioned in the article? (http://www.drugs.com/pro/vytorin.html) ” In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m2, the dose of Vytorin is 10/20 mg/day in the evening. In such patients, higher doses should be used with caution and close monitoring.”
 
4. Where is there mention of further studies discussed in the FDA’s report: “With all the controversy surrounding ezetimibe in the past 18 months, the cardiology community anticipates the results of IMPROVE-IT, the large clinical-outcomes study chaired by Dr. Eugene Braunwald of the TIMI Study Group and cochaired by Dr. Robert Califf  (Duke Clinical Research Institute, Durham, NC). The study will compare simvastatin 40 mg plus ezetimibe 10 mg with simvastatin 40 mg alone in 18 000 patients with a recent acute coronary syndrome. Those results will be available in 2012.
 
I do not mean to attack this particular drug from this particular company, but am using this article as an example of just how unsure I am about what we are being told about the drugs we use and how contradictory the information about these drugs can be.
 
On a happier note, did I tell you that I decided to go to my graduation?  I have earned a high school diploma, Bachelor of Arts, and Masters degree – not to mention the numerous certificate programs I’ve completed – (okay, okay, I know I could be  the poster child for life long learning).  This time, it was an Academic Certificate in Creative Writing from Rio Salado Community College and I realized this might be my last opportunity to attend one of my own graduations, as opposed to being part of or attending others’ graduations. I must say this was such an exhilarating, inspiring experience!  I urge you not to ignore your own milestones.  Take every chance you can get to celebrate yourself. This is my younger daughter, Abby, and me right after the ceremony.   
 
Until next week,
Keep living your life!
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