bunrab: (me)
Best money saved this year: Medicare paid entirely for replacing my defibrillator in August - my entire copays were less than my deductible anyway; compare that to last year's nonsense with the anesthesiologist who wouldn't accept insurance.  Best money spent this year: the extravagant glasses frames. Well, extravagant by my standards, anyway - not ridiculous $700 designer frames, or frames with real gemstones, or nonsense like that, but still, well over $200 instead of my usual pick from the $99-and-under section. Even online, these frames cost over $200, in places where there are $10 frames available. But the compliments make me feel good, and that makes me happy. Yes, it's vanity.

Most fun I had this year that I'm willing to discuss in a family-friendly online forum: going to the International Quilt Show in Houston - it had been ten years since the last time I made it to that, before we left Texas.The trip included seeing old friends and good food, too, and the rest of the stay in Texas gave me time to catch up with Steve's remaining relatives. Least fun this year: my oldest sister passed away yesterday. Cancer. She was a year older than me. We weren't close - her life in Alaska and her deep involvement with fundamentalist religion kept us from talking often or having much to talk about - but still, you know, family. She is survived by 8 children and numerous grandchildren.

Stuff I accomplished: finished several quilts, including some that have been pending since before I left Texas. Got out the Christmas tree and decorated it without crying too much over memories. Worked out a few things with the boyfriend so we could get more deeply involved. Gave an awful lot of stuff to Goodwill. Stuff I didn't quite finish: clearing out the dining room so that two people can comfortably eat a normal meal there - haven't emptied the sideboard enough to sell it yet. Opening all the boxes from storage - there's still half a dozen boxes of stuff unopened, and about a dozen boxes I opened, but they're full of paper I still need to sort through. Still, that's an improvement over the 40-plus boxes I moved out of the storage unit and into the extra bedroom - there's now room for the critters to have floor play time in there.

Speaking of critters, Fernbunny is 10.5 years old, the last of the pets we brought from Texas. She has one eye completely covered with a cataract, and her fur is a little thin in a couple spots, but she can still play a vigorous game of tug-of-war for a carrot treat! The pet count is therefore still steady at Dexter cat, Fern, and the two piggles, Oreo and Theodore.

Now, another thing I didn't quite accomplish this year was to keep current with my friends' blogs here. I did better than the year before, but still, the last two months, I've not gotten on LJ to read or write. I will keep trying to do better, as I want to know that my friends are alive and doing stuff!
bunrab: (me)
So I had the defibrillator replaced on the 29th, and it was so painless and easy compared to all the other surgeries I've had these last 10 years that I feel like there's another shoe that's gotta drop - something can't possibly go that well without anything going wrong! And yet that seems to be the way it worked. Went over to the hospital at 11, was home again before 4, even counting the extra time we had to wait while they rearranged the operating room because someone had forgotten to tell the setup people that my device is on the right side, not the left. It was, as expected, local anesthesia and a bit of sedation, with the sedation increased for a few minutes when they had to test the device after putting it in - the sedation caused some mild hallucinations which I recognized as such while they were happening: the blue woven-paper coverings and pads that they use to cover areas, block things off, rest tools on, turned into a vast rolling Avatar-like landscape. And of course I chatted all the way through the thing, uncontrollably - but the anesthesiologist says she enjoyed it, and that constant chatting is in fact quite reassuring to them.
Boring details of easy recovery )

In other news, I am now officially elected to the condo board, not just appointed, and have already started wielding my immense power - which consists of volunteering to do many, many hours of unpaid work on behalf of the 433 owners who /aren't/ on the board, while enduring complaints from them and hassles from the other new board member who is a nutcase, and an exciteable, shouting nutcase at that. Wonder how long he'll last???

We went to the state fair the weekend after the surgery - and I was fine, although, since this year the scooter rental people weren't there, we didn't get to see much of the fair. In general, I'd have to say that for most ag stuff, the Montgomery County fair was larger and better organized than the state fair - the only place where the state fair has it better, and the reason I wanted to go, was the Home Arts building - many more quilts, knitted things, and needlepoint things at the state fair than there were in Mty Cty. This coming weekend we are going to go to the Great Frederick Fair, which is the name for the Frederick County fair. I've never been to that one, but Frederick is  a big agricultural area, just as northern Montgomery county is, so I have high hopes for fancy goats, obscenely-shaped vegetables, and, since it is a month later than the Montgomery one, much, much larger pumpkins. I shall report!
bunrab: (bathtub warning)
Just a quick update for those of you keeping track - I got this ICD/pacemaker September 3, 2006, so I am now pretty much 7 years into a "5-year battery" expected life of the device - it finally dropped down to the replacement level last month. So I am getting the battery - or generator - replaced this Thursday. To explain that quickly - when they talk about replacing the battery on a pacemaker or ICD, they really mean replacing the whole blob of metal that is the device, everything except the leads. The human body is full of nasty fluids, so pacemakers are sealed very well so as not to have the works damaged by their environment, and that means there's no easy-in, easy-out battery slot; the battery is an integral part of the unit. Which is also referred to as a generator, since it generates those little electric shocks.

The upside of this is that, although the generator is the very expensive part of the device (5 figures), it is very easy to install; it's the leads that are a bitch to install. Lead placement is an overnight (or longer) procedure, which, as you all know, I have had remarkably bad luck with. But device replacement is outpatient surgery, local anesthesia with sedation. So I will be in and out again Thursday afternoon. And, since Medicare is now my primary insurer, I will have no problems with out-of-network anesthesiologists billing me thousands of uncovered dollars - we're going into this knowing that anyone who touches me better take Medicare. The EP (electrophysiologist, or pacemaker/ICD specialist) surgeon is someone from my regular cardiologist's practice whom I've talked to several times, and so we're really clear on what we're NOT doing here - no weird attempts to suddenly be the person to succeed in placing a third lead. In fact, we are putting in the simpler device that doesn't have bi-ventricular lead capacity. Smaller and probably longer life than the current device. All the way around, though any surgery is a nuisance, this one I expect will be less of a nuisance than anything else I've had done anytime these last 10 years.

It's Howard County General, just a few miles from my condo. Cindy is driving me there and back. I'll post to Facebook as soon as they let me have my phone back in the recovery room.
bunrab: (me)
I was discussing the phrase "ye gods and little fishes" with boyfriend the other day, and I swear I remember reading a book as a kid, in which a little girl used that phrase frequently to express her impatience with other people. I cannot remember what book it was - this odd notion comes to me that perhaps it was Cheaper By The Dozen??? Could that be right? If not, does anyone else remember such a little girl using that phrase, possibly in connection with walking to get ice cream? It's very odd what scraps the mind remembers.

I am too lazy to go to the library and find Cheaper By The Dozen just to see if that's it.

This year, our anniversary and Mother's Day came on exactly the same dates it did the year we got married, 1985. It would have been our 28th anniversary. I kept busy and didn't think about it too hard, because who wants to ruin someone else's nice Mother's Day dinner by bursting into tears?

My stepmother lost her first husband when she was considerably younger than I was when Steve died - and she had several small children to take care of as well. (If I recall, her youngest at the time was an infant.) I can only imagine how difficult it must have been for her - and I can see why she would have been happy to meet my dad, even though it wasn't that long afterwards, because she must have been so lonely, surrounded by children who were a constant reminder of what she had lost, without being old enough to be useful in helping her cope with his loss. My stepbrothers and stepsisters never talked about their father very much, though I gather he was rather strict, and chronically ill.

Saturday was our condo community's annual group yard sale. Six boxes of books and two boxes of crafts magazines out the door, along with a few miscellaneous items. Steve's three torque wrenches were the first thing to be sold - lots of guys want those, apparently. The crowd, and what they're looking for, is rather different than Austin; fewer books sold than I had hoped (the leftovers went to the charity donation truck that came at the end, not back into my condo) and a lot more people were looking for clothing, which I hadn't even considered bringing because in Austin, it never sold well - only baby/little kids clothing ever sold at all. Here; people who had women's dresses and suits and shoes were doing a brisk business. I did get a few people who each took an armload of crafts magazines, though, and a few science fiction geeks who picked up 10-20 books apiece. Did a bit of electioneering for the condo board elections this summer - I'm serving as an appointed member, right now, filling in a vacant spot, but I need to get elected to a regular term, and, quite oddly for such things, we have 5 people running for the three open spots (usually it's hard to get anybody to run at all) - so I used this as an opportunity to talk to a bunch of neighbors I hadn't met before, and do a few good deeds - things I would have done anyway, of course, but now I mentioned that I was running, after helping people.

I had my quarterly device check today, and it looks like the battery is holding up enough that we don't have to schedule replacement for July - the power level is still a bit above even the "elective replacement" level, let alone the "mandatory replacement within 3 months" level. So we've scheduled the next quarterly check for August, 3 months from now, with the assumption that at that time, the power will have just dropped into elective replacement then, and since replacement is outpatient surgery, it can be scheduled fairly quickly, probably for later that week. The question will be whether I've healed enough to play in rehearsals that start up around Labor Day - I believe the first concert any of my bands have scheduled for next season is something like September 15. By now, my cardiologist is used to hearing that his schedule comes in somewhere less important than my concert schedule :D

Hey, anyone in Maryland: Maryland Community Band Day is June 9, noon to 8 pm, at the Lurman Woodland Theater in Catonsville. Montgomery Village Community Band is playing at 3 pm, and Baltimore Symphonic Band, as the host band, is playing last, at 7 pm. C'mon out and listen!
bunrab: (Default)
Monday night, after posting on Goodreads, but just as I was about to close Goodreads and come here, I had another v-tach episode. This time, the new programming on the device kicked in so I got "paced" out of the event rather than shocked out of it, which is less violent and less painful, but it's still no less alarming and disconcerting, and it's very, very alarming to have another episode only a few weeks after the previous one. More about how I am coping with this soon.
bunrab: (Default)
A quick summary, for those of you who haven't seen daily Facebook posts and the photos I've uploaded there:
When last seen, I was getting the kitchen in the house in Catonsville touched up, repaired, minorly remodeled, in order to contemplate selling it. It got sold!
Selling the house, buying a condo )
The condo I bought wasn't perfect, but it met my essential requirements: first floor, large enough for me to have a guest room and with room for the critters, pets permitted, safe neighborhood. What I got was a 3-bedroom unit, built in 1982, so not too old by condo standards, though not new. It's in the Long Reach area of Columbia. And this coming Sunday, a Wegman's opens up in Columbia which will then be my nearest supermarket - how cool is that?

More than most people want to know about the condo kitchen )
I am not finished unpacking yet, though I've been here a month and a half. There's still a lot I need to get rid of; cutting down from a house to a condo, even a large condo requires getting rid of a LOT of stuff.  And I had been trying to do a bit too much, so the universe sent me a reminder last week to take it easy, in the form of a v-tach episode that triggered my defibrillator. One emergency room visit later, I have some pretty firm instructions from more people to take it easy, watch how much driving I do (I was forbidden to drive for a week), changed programming in the implanted device, changed dosages of my beta-blocker, which itself is making me tired, and pretty much nothing at all accomplished in the past 10 days.

So of course it struck me as time to whine on LiveJournal!!

And how are all of you?

I will try to post next week: my goodbye pics of the house, some pics of the condo, some pics of the pets, and lots more trivia. Maybe I'll even have time to read a book and mention it!

Could someone please let me know whether the cuts are working?
bunrab: (heart)
In my last post, I mentioned taking pseudoephedrine (actually store brand, but Sudafed is so much easier to type) for a nasty cold, where I couldn't sleep for the postnasal drip and hacking cough. I took it one night, worked well, managed to get through the day without it, took it again the next night - just one, to last long enough to get to sleep. It felt so great - I could feel the line of dryness moving up my nose like the terminator moving across the face of the earth. So, I took a third one the next night - and got woken up a few hours later getting zapped by my defibrillator. So much for the Sudafed experiment. There's a reason they tell us not to take that stuff.

Got an appointment with the cardiologist in a couple weeks - didn't see the need to go in right away, since I can tell what happened and why, and I know enough not to do it again.

Meanwhile, saw regular doctor today, got Astelin nasal spray, which is supposed to clear up the snot locally in the nose, without affecting the whole system or causing high blood pressure or racing heart. I sure hope it works. I am really, really tired of being a great waddling ball of slimy snot.
bunrab: (heart)
I know, it's been a while. I've been lazy!
I have had a cold the last few days, and the postnasal drip has been SO awful that, damn the torpedoes, I have been taking pseudoephedrine at night - otherwise I can't sleep for the slime draining through my nose and throat. Yes, Sudafed is on the no-no list for heart failure patients and anyone with high blood pressure - but darn, I think going without sleep, coughing and sneezing all night, is a more immediate threat to my health than the stimulant effects of Sudafed. I've been doing without it during the day - I'm not going overboard on this.

News article:
Doctors Call for Human Studies of New Defibrillators

Human studies must be conducted before important new technology is used in heart defibrillators, say two prominent heart doctors who helped shed light on previous medical device defects.

The new "four-pole connector" technology is a more compact way of connecting heart defibrillators to wires -- called leads -- that conduct electricity to the heart. It would allow defibrillators to be smaller and leads thinner, which would make the implant procedure easier, the Wall Street Journal reported.

The U.S. Food and Drug Administration plans to allow defibrillator makers to sell the new implantable cardioverter defibrillators (ICDs) without conducting human studies, something that "is not in the best interest of patients," cardiologists Dr. Robert G. Hauser and Dr. Adrian K. Almquist wrote in this week's New England Journal of Medicine.

The Minneapolis Heart Institute doctors said they're concerned the new technology could be prone to potentially deadly short-circuiting, the Wall Street Journal reported.

The FDA disputed the cardiologists' claim that the agency has decided to allow the new devices to be sold without human testing, the newspaper said.

(from HealthDay, Scout News LLC)
bunrab: (Default)

Wednesday, December 28, 2005

Recently I had a MUGA scan done. This was because my most recent echo,a month ago, showed my EF as having fallen back down into the 15-20% range. Doc says that at low numbers like that, the echo isn't very accurate or precise; the MUGA is. I haven't heard the results yet - he's on vacation; I meet with him the day he gets back, Jan 9. Anyway, some of you have heard about MUGAs, and if you haven't, you can read more about them here:
http://heartdisease.about.com/cs/cardiactests/a/muga.htm
http://www.chfpatients.com/tests/muga.htm

Although those sites describe the test, they don't really. What they don't tell you is the "sit and wait" aspects. So here's what it's really like:
Arrive at lab in basement of building at 9 a.m., still 90% asleep. Sign in, sit and wait. After about 10 minutes, a tech gets around to you, and draws some blood, making jokes that you don't get since you're not really awake yet. Then you go back and sit in the waiting room for another 20 minutes, while they add the radioactive stuff to your blood. The stuff's called technetium, which they pronounce tek-NEE-shem. The waiting room has small chairs, cheap, with not much padding, and fewer and older magazines than a doctor's waiting room. So if you didn't bring your own reading material or knitting, you are in for more boredom than usual. They do, however, offer juice or coffee - in most cases, there is no reason why you cannot eat or drink before a MUGA, unlike many other lab tests and scans. So, if you don't have to fast, then one way to pass the waiting time is to bring your own coffee and donuts, or tea and toast, or whatever, for breakfast.

Then you go back in the blood-drawing room to have your blood re-injected into you. Then you go back out to the waiting room, and wait for another 20-25 minutes, for the radioactive blood to circulate enough. Pull out the knitting again, or the crossword puzzle, or your PDA. During this wait, the staff will probably also use the time to give you your "radioactive letter" - a note that says you've had this test done, so that if you have to go into a high-security area, you can explain why you happen to be radioactive. They recommend keeping it with you for 30 days.

Finally you get to go back to the machine. If you are wearing thin clothing, you probably get to keep it on; if you are wearing heavy clothing or clothing with metal on it - women's bras, shirts with snaps or metal buttons - you will probably be asked to undress to the waist. Then you lie down. The description at the web sites above says "you will be asked to hold very still." Actually, they don't count on you for that - what they do is stretch a thin rubber sheet over your thorax (chest) and right arm (your left arm rests above your head) and fasten it down, so that you are held firmly in place. It would take quite an effort to twitch, let alone move much, under there. Then the machine hums and the technician mutters at her computer and the background music plays, for about 15-20 minutes. (I dozed off, so I don't know the exact amount of time; it was at least 4 Christmas carols, though.) And that's it - when they let you up, you get to just leave, and wait to talk to your doctor about the results.

I was pushy enough to ask to see the technician's computer screen, and she ran a bit of the view for me. One can see one's heart clearly; what's surprising is how large and bright one's spleen is!!

Well, results when I get them will be posted here. Till then, Happy New Year!

keywords: MUGA, scan, EF


A couple of articles about Guidant ICDs

Three new deaths associated with Guidant devices
Dec 15 (Reuters) - Guidant Corp has filed reports with the US Food and Drug Administration about three new deaths associated with short circuits in its heart devices, the New York Times reported on Wednesday.
Citing FDA records, the newspaper said the deaths occurred after Guidant recalled the heart devices in June.

Guidant has faced intense scrutiny in recent months over its failure to inform doctors about potential defects in some of its implantable devices used to manage abnormal heartbeats.

It eventually recalled some of its most lucrative implantable heart devices because of concerns about their safety. Sales have since resumed.

Including the new reports, number of deaths associated with the flaws has reached seven, the Times said. It said doctors and families of heart patients may be more likely to have the units checked for problems after a death because of the increased scrutiny on Guidant.

According to the report, Guidant said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies," and has recently been releasing more detailed information about product malfunctions.

In October, Guidant said it had received a Justice Department subpoena concerning some of those recalled heart devices, which regulate abnormal heart rhythm and protect against heart failure. Two other makers of heart devices also got subpoenas.

Guidant, which is the target of competing takeover offers from Johnson & Johnson and Boston Scientific Corp., was not immediately available for comment.

Publish Date: December 15, 2005


Heart Device's Export Blocked - FDA Questions Rhythm Stabilizers From One
Guidant Plant


By Marc Kaufman
Washington Post Staff Writer
Wednesday, December 28, 2005; A02


The Food and Drug Administration has told Guidant Corp., a maker of medical
devices, that it will not approve new contracts to export heart-rhythm
stabilizers made in its Minnesota plant until the company can prove that its
products are being properly made.

In a warning letter from the agency, the troubled company was also informed
that it had to make significant improvements in its manufacturing practices
before any additional company devices could be approved for sale.

Guidant acknowledged in a statement on its Web site that it received the
formal FDA warning Dec. 23, and that it outlined quality-control issues at
its St. Paul plant. The warning letter covered a broad range of
still-uncorrected problems first identified by the FDA during a September
inspection.

But, Guidant said in its statement that it has "taken a broad, thorough and
systemic review of its quality system and has made substantial steps toward
addressing all" of the FDA's concerns. The company has fulfilled 90 percent
of its upgrade commitments, the statement said.

The intensive FDA inspection followed a series of recalls and warnings
issued for Guidant's heart defibrillators and pacemakers because of reported
malfunctions, some of them fatal. Federal and state officials are
investigating the company, which faces dozens of lawsuits over its recalls.

After the inspection, FDA officials said that the company did not properly
warn doctors about software problems that caused some pacemakers to
malfunction, that company quality control was ineffective at several levels,
and that record-keeping was poor.

FDA spokesman Jason Brodsky said that while Guidant remains out of
compliance with good manufacturing practices at the St. Paul plant, the
agency had no additional product warnings yesterday for patients and their
doctors.

"We're working with the company now to bring them into compliance," Brodsky
said. "There are significant manufacturing concerns, but we have no new
recommendations for use of the products."

Brodsky said that the FDA's refusal to issue new export certificates for the
plant or to approve new device applications is not a new regulatory action
but rather a consequence of the plant remaining out of good manufacturing
compliance.

In the warning letter to Guidant, Minneapolis District Director W. Charles
Becoat said that the company had submitted five letters since early
September outlining its plans to improve the St. Paul plant. Nonetheless, he
wrote, "You have failed to address all of the significant violations . . .
and will receive additional correspondence detailing the inadequacy of your
response."

The company's devices are implanted in cardiac patients and use electric
shocks to correct faltering heartbeats. While the problems of some implanted
defibrillators and pacemakers have tarnished the industry, agency and
industry officials say that failure rates remain low and the devices are
often lifesaving.

Guidant's manufacturing problems have emerged as two larger companies --
Johnson & Johnson Co. and Boston Scientific Corp. -- have negotiated to buy
the company. Johnson & Johnson reduced its offer by almost 20 percent after
the problems arose, and then Boston Scientific countered with an offer
similar to the initial one from Johnson & Johnson.

Guidant stock dropped by almost 3.5 percent yesterday on the New York Stock
Exchange. The decline was the biggest since the price fell almost 5 percent
last month after New York Attorney General Eliot L. Spitzer accused the
company of misleading doctors about a design flaw in its defibrillators.
© 2005 The Washington Post Company
(keywords: Guidant, ICD, defibrillator, pacemaker)

bunrab: (Default)

Tuesday, August 16, 2005

Cocoa fights heart disease
Aug 12 (HeartCenterOnline) - A cup of cocoa may actually be good for your heart, according to researchers in Great Britain.

Chocolate and cocoa have long been used as medicines. In fact, cocoa was originally marketed as a health tonic in the United States - and it appears there is an element of truth to the folk wisdom.

Cocoa is rich in flavonoids, which have been shown to inhibit blood clotting. This may reduce the risk of conditions caused by abnormal blood clotting, such as heart attack and stroke. Flavonoids are the same substance found in red wine, which also has been shown to have cardioprotective effects.

According to researchers, the discovery that flavonoids may help prevent blood clotting may lead to new medications, or "it may also mean that a nice hot cup of cocoa may take on new importance for people in high risk categories, " according to Dr. Denise O'Shaughnessy, who was quoted in a release describing the study.

The research was presented at the Congress of the International Society on Thrombosis & Haemostasis.

Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 12, 2005

Surgery extends mortality in cardiomyopathy
Aug 05 (HeartCenterOnline) - Patients with an abnormally thickened heart, or a condition known as hypertrophic cardiomyopathy, appear to live longer after having surgery, according to a new study.

Hypertrophic cardiomyopathy occurs when the walls of the heart, particularly the muscular wall that separates the chambers (the septum) are abnormally thickened. As a result, blood flow in the heart is reduced, causing symptoms such as shortness of breath, chest pain, dizziness or fainting. It severe cases, hypertrophic cardiomyopathy may cause sudden cardiac death. It is the most common cause of sudden death during athletic events.

Hypertrophic cardiomyopathy may be treated with a surgery called a myectomy, in which a portion of the thickened muscle is removed surgically. Numerous studies have shown that patients report feeling better after the surgery, but until now, no studies had been conducted showing a benefit to lifespan after myectomy.

Researchers from Mayo Clinic conducted a retrospective study of 1,337 patients evaluated at the clinic between 1983 and 2001. Of them, 228 had hypertrophic cardiomyopathy and had undergone myectomy. Another 228 had the condition but did not have surgery. The remaining patients had the condition, but suffered from no obstruction to their blood flow.

Researchers found that, within 10 years of diagnosis, almost 40 percent of patients who did not have surgery had died. By contrast, only 17 percent of patients who had undergone surgery had died. This death rate is the same as normal health patients, meaning that the mortality rate for myectomy patients was statistically the same as patients with non-obstructive hypertrophic cardiomyopathy or people in the general population of the same age and gender.

In a release describing the unpublished study, researchers remarked that patients undergoing myectomy can now be assured that the surgery has a good chance of extending their lifespans.

Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 05, 2005

Tuesday, August 09, 2005

The September issue of CR has a notice about the recall of various Guidant defibrillators.

Luckily, my model isn't among them, but I had to do some searching to find that out - the recall lists everything by the model name, but my wallet card lists everything by model number, and I had to plow through several pages of Guidant's web site to find out the name of mine to match the number. (Model H115
CONTAK CD 2)
(here's the link: http://www.guidant.com/webapp/emarketing/mydevice/listing.jsp this allows you to select a model number from a drop-down box, and then when you go to that page, it lists the model name as well as number.)

Monday, August 08, 2005

When a Heart Device Short-Circuits (NY Times)

August 7, 2005
When a Heart Device Short-Circuits

Defibrillators that shock a chaotically beating heart back to normal and
pacemakers that regulate a heart's rhythm have saved or improved the lives
of hundreds of thousands of people. But every so often one of these
implanted devices fails to work when it is desperately needed. The story of
how the Guidant Corporation, the nation's second-biggest maker of cardiac
devices, handled a flawed defibrillator provides a troubling glimpse into
the murky world of medical device regulation.

The problems came to light after a college student with a genetic heart
disease died in March while he was mountain biking in Utah. When Guidant
analyzed the device, it found that the unit had short-circuited. Worse yet,
the same model had short-circuited earlier in more than two dozen other
patients. Yet when the dead student's doctors asked Guidant officials how
they planned to get the word out, the officials said they saw no reason to.
It was only when The Times was about to publish an article by Barry Meier
exposing the problem in late May that the company issued an alert. The
article revealed that Guidant had known about the flaw for three years but
told neither doctors nor patients.

The company's justification for its reticence won't wash. Guidant said it
corrected the flaw in 2002 but saw no need to inform doctors because the
devices made before then were highly reliable and the surgical risk of
taking them out might outweigh the very low risk of failure. Incredibly, the
company kept selling the potentially flawed devices from inventory for
months after it began making improved versions. To this day it maintains
that all the devices are highly reliable, but surely there are few doctors
who would want to implant a device with a flaw that had been corrected in
more recent units. By failing to disclose the flaw publicly, the company
pre-empted a decision - whether to remove the flawed devices surgically -
that should be made by doctors and patients.

With the company facing heightened scrutiny from regulators and a steady
drumbeat of articles by Mr. Meier, Guidant has issued alerts or recalls on
20 models of defibrillators and pacemakers, comprising tens of thousands of
devices in all. For the future, the company, the Food and Drug
Administration, a heart rhythm medical society and the chairman of a Senate
committee are all pondering ways to increase the flow of information on
flaws in medical devices. It will be equally important to improve the
monitoring of these devices after implantation. Their generally reliable
performance must not obscure the fact that when they fail, the results can
be catastrophic.

* Copyright 2005 The New York Times Company


August 6, 2005
F.D.A. Will Not Release Some Data on Heart Devices
By BARRY MEIER

The Food and Drug Administration said yesterday that it would not release
information that it receives annually from the makers of heart devices
detailing how often and why products fail. The agency called such data a
corporate trade secret.

The F.D.A. took its position in response to a Freedom of Information Act
request from The New York Times, which had sought annual reports filed by
the Guidant Corporation in connection with a defibrillator, the Ventak Prizm
2 DR. From 2000 to 2002, Guidant made thousands of the devices, some of
which had electrical flaws that caused them to short-circuit. In March, a
college student with a flawed device died of cardiac arrest.

The agency's position may put it at odds with Senator Charles E. Grassley,
Republican of Iowa and chairman of the Senate Finance Committee. Senator
Grassley recently wrote to the commissioner of the F.D.A., Dr. Lester M.
Crawford, asking the agency to explain why it did not make product data from
device makers' annual reports publicly available on a regular basis.

Senator Grassley, who last year held hearings on the agency's post-marketing
scrutiny of drugs like Vioxx, said yesterday that he was disappointed by the
latest decision.

"The F.D.A. needs to find reasons to make information public rather than
working overtime to withhold findings that the public deserves to know
about," he said. "Amid the scrutiny of the last year, the F.D.A. has
acknowledged that the public wants and needs to know, but so far the
agency's actions haven't matched its words."

Under little-known F.D.A. regulations, the makers of defibrillators and
pacemakers must provide detailed data each year to the agency, including the
frequency of failure in individual models, the cause of such failures and
the number of deaths and injuries.

A defibrillator sends an electrical charge to the heart to interrupt a
chaotic and potentially fatal rhythm. A pacemaker regulates a heart that is
beating too fast or too slowly.

The product-performance data submitted to the F.D.A. by manufacturers is
more detailed than that they provide to doctors, industry officials said.

The F.D.A. - in responding to a Times request for all annual reports filed
by Guidant in connection with the Ventak Prizm 2 DR - said that it would not
release the product performance data for that device and similar ones made
by Guidant.

The F.D.A. said yesterday that such information, be it from Guidant or
another maker, constituted confidential trade information.

"This information is a trade secret and exempt from release," an agency
official, Joy B. Lazaroff, wrote in an e-mail message.

An F.D.A. spokeswoman, Julie Zawisza, said in June that while the agency did
not make such filings public on a regular basis, it might do so if a Freedom
of Information request was filed.

In addition to the annual reports, makers are also required to file reports
with the F.D.A. on possible product failures, including those related to
potential patient injuries.

A review of the reports filed by Guidant that the F.D.A. recently placed on
its database showed that both the frequency of electrical failures of the
Ventak Prizm 2 DR and its consequences for heart patients were increasing
before the March death of a college student who had a flawed device.

The review also showed that about 14 of the 28 known failures occurred from
January 2004 to this March. In addition, both the death of the student,
Joshua Oukrop, as well as most patient injuries potentially related to the
device's flaw took place during the same period, the filings show.

In 2002, Guidant executives discovered that the device was prone to
short-circuiting, which would render it useless. The company fixed the
problem in 2002 but did not alert doctors for three years until it became
aware that the problem would be disclosed in other public forums. In
addition, Guidant kept selling older versions of the device even as it was
selling an improved version in which the electrical flaw was eliminated.

Under F.D.A. regulations, a company is required to analyze the risks posed
by a device and make an assessment as to how to respond. A manufacturer must
keep records of how it made such assessments on file for review by F.D.A.
officials. Specialists on medical-device regulation said a company was
supposed to regularly review its course of action and possibly revise it if
events, like an increasing rate of product failure reports, warranted it.

Executives of Guidant, which is based in Indianapolis, have said that the
company made all required filings with the F.D.A. regarding individual
reports of device failures and told the agency in 2003 about the
manufacturing change that fixed the flaw. Companies, however, do not have to
file risk assessments with the F.D.A.

A spokesman for Guidant, Steven Tragash, declined to respond to written
questions on the frequency of the risk assessments of the Prizm 2 DR,
including if one had been done in March when Mr. Oukrop died and another
heart patient nearly died. The role of the device in both incidents is not
clear.

Mr. Tragash declined to make the chief executive, Ronald W. Dollens, or the
head of its heart device unit, R. Frederick McCoy Jr., available to be
interviewed. Guidant also did not respond to written questions about when,
or if, Mr. Dollens and Mr. McCoy became involved in discussions on whether
to issue an alert about the Prizm 2 DR to doctors.

In December, Guidant, which derives about half of its revenue from
defibrillator sales, agreed to be acquired by Johnson & Johnson in a deal
worth $25.4 billion.

The exact number of problem reports filed by Guidant each year in connection
with the Prizm DR could not be determined because the reason for a device's
failure is not always readily apparent from the language. But the filings
indicate that Guidant made 2 reports in 2002 about short-circuiting in the
Prizm 2 DR; some 8 such reports in 2003; some 11 reports in 2004; and 4 in
the first three months of this year.

* Copyright 2005 The New York Times Company

Thursday, August 04, 2005

Cholesterol Drugs & Heart Failure
A common cholesterol-reducing drug may lower the risk of death from heart failure. Read the complete article: Statin therapy lowers mortality in heart failure. For more information, visit HeartCenterOnline's Cholesterol Center or Heart Failure Center. Or, view all Cholesterol News or Heart Failure News.

You can also check out the Heart Failure Quiz.

And other articles:
Topiramate lowers weight and blood pressure
Statin therapy lowers mortality in heart failure


I've been doing OK since I arrived in Maryland; it's been 10-15 degrees cooler than in Austin except for the last 2 weeks. Right now it's as hot and humid as Austin. But even so it doesn't feel quite as bad, because there isn't heat soaked into the ground from months and months of temperatures near 100 degrees. There are still lots of shady trees, and the grass is green, which keeps the ground temperature cooler.

My big worry right now is that my insurance, from the Employees Retirement System of Texas, still hasn't told me what my coverage is for finding a new cardiologist up here, so I don't have a doctor. My old doctors back in Austin are not going to authorize my prescription refills in Maryland forever, so I really need to find a family doctor and a cardiologist soon, and I really should find an electrophysiologist as well, since it'll be time for another ICD/pacemaker reading/check-up in another month or so. So I guess I need to phone ERS and hassle them a bit, to find out what my coverage limits are now that I'm "out of area." (For that matter, I still haven't found anyone to cut my hair, either, and that needs doing, but at least I don't have to wait on insurance for that! Moving certainly discombobulates one's life, even when it's overall for the better.)

Profile

bunrab: (Default)
bunrab

April 2017

S M T W T F S
      1
2345678
91011 12131415
16171819202122
23242526272829
30      

Syndicate

RSS Atom

Most Popular Tags

Style Credit

Expand Cut Tags

No cut tags
Page generated Aug. 19th, 2017 06:36 pm
Powered by Dreamwidth Studios