Good, Bad or Unnecessary?

When I came home from Portland, I had this crazy desire to clean – although Bear always keeps the house in pristine condition when I’m gone.  I tried to ignore it, but that didn’t work.  So, I cleaned, right down to cleaning out the articles I keep for the blog.  Of course, being me, I had to read each one before I trashed it. Lo and behold, I started seeing a pattern with some of them.

On Halloween of last year [my brother, Paul Peck’s birthday, by the way], this article appeared.  By the end of the blog, you’ll be able to figure out if it was a trick or a treat.

FDA staff say Merck’s Vytorin helps kidney patients

(Reuters) – U.S. Food and Drug Administration reviewers said Merck’s cholesterol-lowering drug Vytorin was effective in reducing the rate of heart attacks or other cardiovascular problems in patients with kidney disease.

The FDA reviewers also said Merck’s blockbuster drug, which pairs a new type of cholesterol fighter Zetia with Merck’s older statin drug Zocor, is unlikely to cause or promote cancer.

But, as I read further in the article, I found that Vytorin contained the generic drug simvastatin which had already been approved to lower cholesterol.

You can read the entire article at: http://www.reuters.com/article/2011/10/31/us-fda-merck-vytorin-idUSTRE79U33Y20111031

Something nagged at me, so I went to Drugs.com to check out Vytorin.  This is what I found there:

What is Vytorin?

Vytorin contains a combination of ezetimibe and simvastatin.

Vytorin is used to treat high cholesterol in adults and children who are at least 10 years old.

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or “statins.” Simvastatin reduces levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL).

[Another of Vytorin’s original claims had been that it attacks both genetic and life habit causes of hyperlipidemia.  Remember those tv ads about whether what you ate or Uncle Frank’s genes caused your high cholesterol?  That’s where this claim was made.]

As I kept reading, I found two disturbing warnings:

  1. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
  2. Avoid eating foods that are high in fat or cholesterol. Vytorin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

So a pill that combats high cholesterol on both fronts – genetics and life habits – still requires a life habit change [diet] but could kill CKD patients when given to them to avoid heart problems.  I was not happy.

But it gets even weirder [Did you know Portland’s city motto is “Keep Portland Weird”?] Remember that simvastatin supposedly lowers bad cholesterol and raises good cholesterol and that simvastatin is the generic drug in Vytorin.

‘Good’ cholesterol’s heart benefits challenged

Drugs to raise HDL can’t be assumed to reduce heart attack risk

CBC News

Posted: May 17, 2012 3:46 PM ET

Having naturally high levels of “good” cholesterol doesn’t lower the risk of heart attacks as believed.

LDL cholesterol is referred to as “bad” cholesterol because when there’s too much, it promotes the build-up of plaque in artery walls.

HDL cholesterol is known as “good” cholesterol because higher concentrations have been associated with lower risk of heart attacks in observational studies.

The hoped for benefits of increasing high-density lipoprotein or HDL cholesterol for lowering heart attack risk haven’t panned out in randomized trials of experimental drugs.

According to conventional wisdom, those who inherit genetic variants for higher HDL levels should have lower cardiovascular risk. When researchers tested 116,000 people, they found 2.6 per cent of them were genetically

This article’s address is:  http://www.cbc.ca/news/health/story/2012/05/17/cholesterol-good-hdl-heart-attacks.html?cmp=rss

So you may be taking a drug prescribed to treat your hyperlipidemia but it doesn’t matter if your good cholesterol is raised, even though that’s one of Merck’s [the manufacturer] claims.  In addition, it is possible that this drug prescribed to prevent heart problems in CKD patients may kill them. Why do I get the sinking feeling that this is business as usual for the drug industry?

On another note, several medical personnel I met in Portland brought the book into their hospital.  Thank you Kenyon Decker and Corinna Bayer for bringing the book to Portland VA Medical Center.  Mark Anderson was kind enough to bring the book to the attention of the Oregon Urology Institute, while Marc Overbeck, the director of Oregon Primary Care Office at the

Office for Oregon Health Policy & Research introduced the book there. Dr. Greg Nigh’s wife (who neglected to give me her name, unfortunately) took the book to her husband Nature Cures Clinic, LLC. Another nurse, a Reiki master and others took the book to share with their practices.  Landmark people are wonderful when it comes to doing good works!  If you were one of these unnamed people, leave a comment and I’d be more than glad to get your name in print by way of a thank you.

Unfortunately, I need to report that the medical bracelet I am so unhappy with is now thoroughly discolored – something else that was not mentioned before I bought it.  I would notify the company but am lax to do so since they didn’t respond to any of my other emails.

Also, if you’d like to leave a comment, please don’t use your work address.  WordPress classifies it as spam and even though I go through all the comments, without a working email address I am not confident that WordPress has made a mistake.  In other words, make sure there’s a working email with your comment so it doesn’t get lost in the spam folder.

Wow, this was a long one.

Until next week,

Keep living your life!

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!