If we could improve the regulatory environment of health care, what would those improvements be, and what would it take for us to achieve them?A webcast of the proceedings can be seen here (just click on the person's name in the left-hand column to view their presentation - Windows Media player required).
Tomorrow, the FDA will review the Chronicle – an implantable hemodynamic monitor (measures heart pressures) made by Medtronic, Inc. that is used for long-term measurement of patients with congestive heart failure. The device looks just like a pacemaker (in fact it uses one of their old pacemaker generator cans) but does not pace. Instead, the device measures the time, surface EKG, temperature and right ventricular heart pressures on a continuous basis. Patients can then upload this information via the internet to a central database for their doctor to review in an attempt to facilitate their management.(WSJ) As evidence mounts that nicotine-laced stop-smoking aids are producing only limited gains, some critics are calling the products over-rated and over-promoted.Over-regulation as the cause for lack of utilization? How about the methadone/heroin analogy? Maybe the reason people aren't using these meds is because they're expensive and people don't like taking drugs - especially one that is powerfully addictive. And there are even researchers who question the efficacy of these drugs to stop the smoking habit in the first place.
But some high-profile public-health experts say the problem may be over-regulation. They say that federal law requires nicotine gums, patches, lozenges and other products to carry so many warnings that smokers are reluctant to use them. Indeed, the warning literature on a package of nicotine gum is about 20 times lengthier than the warning on a package of cigarettes.
So tobacco researchers and policy makers are starting to argue that the federal Food and Drug Administration should tone down the warnings on pharmaceutical nicotine. At a day-long summit last week in Austin, Texas, entitled "The Case for More Flexible Regulatory Policy," public-health experts discussed a number of changes they may seek to current regulations. Among other possibilities, they say they may recommend relaxing the health cautions for pregnant women and eliminating the requirement that teenagers refrain from using over-the-counter nicotine products without the approval of a physician.
"A 17-year-old smoker of 25 cigarettes per day is doing the right thing to use nicotine gum," says Jonathan Foulds, a tobacco researcher at University of Medicine and Dentistry of New Jersey. "Why give him another hurdle to cross to get help?"
Recent studies of successful quitters have suggested that the significant benefits of nicotine products seen in randomized clinical trials may not apply in real-world conditions. Critics say the public-health experts who favor nicotine medicines are too financially tied to manufacturers to see the products' limitations. And use of nicotine by teens, pregnant women, heart-disease patients and smokers who haven't quit remains controversial.To think that people actually READ a warning label and that this is the sole cause of the lack of utilization of these smoking cessation drugs belittles any real analysis of human behaviour.
"The use of nicotine, whose efficacy in treating nicotine addiction is controversial even in adults, must be strictly avoided in pregnancy, breastfeeding, childhood and adolescence," argues an editorial in the current Journal of Health Psychology, written by a group of eight researchers and antismoking advocates.
(NYT) Mr. Fontana, a 42-year-old salesman, has a high-deductible health plan coupled to a health savings account. Since he was nowhere near meeting his deductible, he was on the hook for the entire bill.I think this will get filed under "Why didn't I think of that?"
So he did something that insurance companies routinely do: he forwarded the bill to a claims adjuster, in this case My Medical Control, a Web-based company that reviews doctor and hospital bills for consumers.
After concluding that Mr. Fontana was not getting the best possible price, the company’s representatives called the imaging facility and demanded a lower one, promptly saving him $200 — minus a 35 percent collection fee.
Dr Colin Waine, chairman of the National Obesity Forum, said that removing a child from their family could be justified.It seems his mother feels otherwise:
"The long-term impacts of this child's gross obesity are frightening.
"He has great risk of diabetes and coronary illness.
"His life expectancy is severely prejudiced. So action is required if his health is to be safeguarded."
A spokeswoman for North Tyneside Council and North Tyneside Primary Care Trust, a spokeswoman said on Sunday: "We share the concerns over the child's health and well-being.
"We have been working with the family over a prolonged period of time and will continue to do so.
"The child's interests are paramount."
She said she had seen doctors, but no-one had actually stepped in to offer her help.Can anyone say "civil liberties?"
She said that taking Connor into care would be "disastrous".
After one son’s death and a heart ailment that caused another son to require a transplant last year, Kim Nash is taking her daughter to a cardiologist next week.How very ironic and very sad.
“My son,” she told The Associated Press amid sobs, “is giving me the strength right now to talk.”
Damien Nash collapsed in his suburban St. Louis home after returning by limousine with his wife, Judy Nash, and their daughter from a game at his high school to benefit The Darris Nash Find a Heart Foundation. The organization raises money for heart transplant research.
Interesting piece on thoracic outlet syndrome as a cause for pulmonary embolus was presented today in the New York Times. As such, this was not thoracic outlet syndrome, but rather thoracic "inlet" syndrome (veins bring blood flow into the thorax, after all), also known as Paget-von Schrötter syndrome:Three potential compression sites responsible for thoracic outlet syndrome include:Physical exam: the lost art of medicine.
1. Interscalene triangle - borders include anterior and medial scalene muscles and the first rib.
2. Costoclavicular space - between clavicle and first rib.
3. Pectoralis minor tunnel - space between pectoralis minor tendon anteriorly and coracoid process of scapula.
The majority of patients have one of the following congenital or acquired conditions in one or more of the potential compression sites:
Congenital lesion include cervical ribs, scalenus minimus muscle, wide insertion or hypertrophy of anterior scalene muscle, anomalous first rib, slender body habitus with a long thin neck. Acquired lesions include extreme muscular build, fractures to clavicle or first thoracic rib with nonanatomic alignment or exuberant callus formation, supraclavicular tumors or lymphadenopathy.
Effort thrombosis is a form of post-traumatic thrombosis of the axillary vein, usually observed in younger individuals following exercise or occupational activity. The etiology is compression of the axillary vein by either subclavian muscle or costocoracoid ligament during forced abduction. This is known as Paget-von Schrötter syndrome.
"I noticed everybody was standing around him and he was just laying there dead on the floor and nobody was doing anything," DeYoung said. That's when instinct took over for DeYoung, who gets annual CPR training for his Statesville job.It's amazing how many people were at this fundraiser, but how few knew (or were willing to acknowledge their knowledge of) CPR.
"I don't even remember walking over to him," he said. "I just remember being next to him and starting to do chest compressions."
Meanwhile, a bystander had pulled Edwina away from the blackjack table and pointed to her husband. She rushed over and time seemed to slow down as she saw DeYoung begin CPR.
"It was very surreal, like my own out-of-body experience," Edwina said.
As the scene unfolded, Edwina remembers with crystal clarity that a woman, another partygoer, took a deep breath and said, "Oh my God, it's me" before joining DeYoung at Hal Cowell's side.
The woman was Nancy Flitcraft, who had her own slow motion moment in the instant after Cowell collapsed.
She immediately thought back to the day in 2000 when she and her husband tried to revive a 7-year-old boy who had suffocated in an accident. Flitcraft, a nurse who had performed CPR before on several occasions, had given her husband hurried instructions as they worked over the boy's body, but it was too late. He was gone.
Flitcraft hadn't done CPR since the boy died. Her family had spent years trying to work through their sadness about witnessing the accident and not being able to help. But in the few moments after Cowell collapsed, instinct took over for her, as well.
Testing of a new left ventricular assist device (LVAD) developed by an Australian company, Sunshine Heart, is in its very early stages of testing that has the advantage of not contacting the blood pool. In its early design shown here, an inflatable bladder encases the ascending aorta and uses the patient's own EKG to time the inflation and deflation of the bladder surrounding the aorta - it deflates when the heart contracts (systole) and inflates when the heart is relaxed (diastole). It function is analogous to intraaortic balloon pumps used in catheterization laboratories that use counterpulsation to decrease the work of the heart and improve coronary blood flow, but its mechanism resides outside the aorta, rather than within it, limiting the need for blood thinners with the device. An animation of the device is also demonstrated at the company's website.
TriageIf we think of our national health care funding resources as limited, then should we invoke a philosophy of triage of those resources - that is, distribute these resources to do the most good for the most people?
Pronunciation: trE-'äzh, 'trE-"
Function: noun
1: the sorting of and allocation of treatment to patients and especially battle and disaster victims according to a system of priorities designed to maximize the number of survivors.
– from the French word “trier” – “to pick, cull” with some convergence from the Latin “tria,” or “three.” In World War I, it was adopted for the sorting of wounded soldiers into three groups according to the severity of their injuries. It is a term commonly used in emergency rooms, on battlefields and at disaster sites when limited medical sources must be allocated.
"In many countries, including the United States, more women than men die every year of cardiovascular disease, a fact largely unknown by physicians."Some tidbits from that paper:
The current study was an epidemiologic study and does not prove a cause-and-effect relation. This study does not provide a valid basis for recommending increased consumption of caffeinated beverage.Too bad the press couldn't have read this as well before publishing their piece suggesting that grandma or grandpa get stoked with coffee each morning to prevent a cardiac death.
A T-shirt that you are willing to sacrifice in the name of loveI just don't know how comfortable it would be, but it sure would turn some heads.
98 3mm red LEDs (1.8-2.1V @ appx 10 mA)
two DM7474 IC's (flip flops)
one DM7492 IC (2 input nand gate)
one ne555 timer
4.7 uf capacitor (over 9 volts)
.01 uf capacitor
.1 uf capacitor
one variable resistor (100k ohm max)
one 470 ohm resistor
three 1k ohm resistors
one 560 ohm resistor
1 nine volt battery + clip
Foam
Tape
Hard Drive cable (or wire)
Another T-shirt or some fabric
Needle + Thread (or a sewing machine)
wire cutters
Soldering Iron
Solder
Chicago's first foie gras bust went down Friday morning at a hot dog joint on the North Side, just as Doug Sohn was about to open for the day.We'll be looking for similar busts in New York (and other locales nation-wide) over the recent trans fat ban.
It could hardly have come as a shock.
Sohn, the owner of Hot Doug's, had been itching for a fight since the City Council overrode the angry veto of Mayor Richard "It's the silliest law ever" Daley. The ordinance took effect Aug. 22.
Sohn was issued a warning several months ago, but he stood his ground. He continued to serve his foie gras-laced hot dogs at his restaurant in the 3300 block of North California Avenue, advertising their ingredients on his Web site and on a board hung boldly near his front door. "I was poking the grizzly bear, and it snapped my head off," Sohn said Friday.
He was slapped with a citation, and his foie gras was sealed as evidence by a Health Department inspector. Sohn faces a fine of $250 to $500 at his March 29 date with a hearing officer, who could set the amount at the higher end if he or she senses a disregard for the law.
On Friday afternoon, Sohn seemed to be considering whether to fight on. He took the duck-liver dogs off the menu and got ready to go on vacation. If anyone wants to reach him, he'll be considering his options over a plate of foie gras in France, where they are surely shaking their heads.
The program aired secretly shot video of a Vancouver doctor touching a table in a contagious person's room and not washing his hands after, and a nurse who changed the bandages on an open wound and did not wash her hands.Good grief! The real question is, did they play "gotcha?"
The "basket catheter" is actually an 8-splined catheter with 8 electrodes per spline and is shown here:
Now, with all of those wires in the heart, we can record signals from all of them simultaneously and display them on a computer. An example of the recordings taken from all of these wires is shown here (click to enlarge):
"The FDA knows that our actions and our decisions require adequate resources," he added. "We are not focused on where the resources come from, but only the purpose for which those resources are in fact necessary - to protect and promote the health of the public we serve."They are not focused on where the resources come from?
Walther Mothes of Yale University in New Haven, Connecticut, and his colleagues fluorescently labelled three retroviruses, including HIV, and tracked their movement between cells. Compressing a video of the process into a single picture reveals the tracks of viral particles (which appear green in the image) crossing cytoplasmic bridges. Interactions between a viral envelope protein and proteins on the uninfected cell surface seem to stabilize the bridges.-Wes
The experiments were performed in cell culture, but if the findings hold in vivo they could suggest new therapies to limit retroviral spread.
The Medtronic engineer demonstrated a "brain clapper" that monitored alpha waves to tell when a subject's eyes were open or closed. By opening and closing his eye in a demo video, Denison was able to turn a light on and off in his lab.Next up: a new way to select a tune on your iPod...
| Cause of Death | Therapy | Events | Follow-up,Pt yr | Incidence(%) (95% CI) |
|---|---|---|---|---|
| Sudden Death, death due to ventricular fibrillation/tachycardia or cardiac arrest | Placebo | 2 | 169.3 | 1.17 (0.14, 4.18) |
| Ranolazine | 21 | 1847.9 | 1.13 (0.70,1.72) | |
| Cardiovascular | Placebo | 3 | 169.3 | 1.76 (0.36, 5.05) |
| Ranolazine | 45 | 1847.9 | 2.41 (1.76. 3.21) | |
| All cause | Placebo | 3 | 169.3 | 1.76 (0.36, 5.05) |
| Ranolazine | 53 | 1847.9 | 2.83 (2.13, 3.68) |
Among the weaknesses of our study are the relatively small number of outcomes (coronary deaths) and the comparatively short follow-up period. (6 years)Note, these were not cardiovascular deaths, but coronary deaths and only men showed a difference in deaths (there were too few numbers of deaths in women). Hello, researchers! Too few data points are a big problem, no?
MIT researchers Manu Prakash and Neil Gershenfeld have succeed in creating a unique form of binary logic using tiny bubbles to simulate a computer's computational ability, allowing the potential for these bubbles to carry a tiny chemical payload that may have implications for drug-delivery systems built from tiny microfluidic circuits. You can see an example of their work here or read their paper in the journal Science.(Doctor) Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies.What is interesting is the way the government makes these recommendations: based on clinical trials. And who is better equipped to perform clinical trials than drug companies? (Bias 1). Further, all of the individuals in clinical trials must sign consent, and therefore have to be willing to take a drug (Bias 2). So these "clinical trials" are, by their very nature, skewed toward those willing to take a drug.... Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products.
Those opposed to urging medication on most quitters note that cold turkey is the method used by the vast majority of former smokers. They fear the federal government's campaign could discourage potential quitters who don't want to spend money on quitting aids or don't like the idea of treating their nicotine addiction with more nicotine.
"To imply that medications are the only way is inappropriate," says Lois Biener, a senior research fellow at the University of Massachusetts at Boston who has surveyed former smokers in her state. "Most people don't want them. Most of the people who do quit successfully do so without them."
Studies of quitters outside clinical trials have shown no consistent advantage for medicine over cold turkey, the pharmaceutical industry's primary competitor. An unpublished National Cancer Institute survey of 8,200 people who tried quitting found that at three months, users of the nicotine patch and users of bupropion (Wellbutrin) remained abstinent at higher rates than did users of no medication. But at nine months, the no-medication group held an advantage over every category of stop-smoking medicine. The study was presented at a world tobacco conference last summer.But the potential conflicts with the pharmaceutical industry don't end there:
The American Cancer Society has allowed its logo to be placed on stop-smoking products in exchange for money. A Cancer Society spokesman defends that decision, crediting the pharmaceutical industry for bringing invaluable marketing muscle to the society's Great American Smokeout every November.Gee, I wonder why. Lots and lots of Wellbutrin and Nicorette is sold each November, I'm sure. Gotta "raise that public awareness" now don't we? It seems personal responsibility has gone out the window.
New policy recommendations were released this week by the Heart Rhythm Society and American Heart Association regarding driving restrictions in patients with implantable cardiac defibrillators (ICDs). These newer guidelines were basically a supplement to earlier guidelines published in 1996 when most ICDs were placed after individuals already had a documented arrhythmia or episode of aborted sudden death ("secondary prevention"). These newer guidelines extend the former guidelines to also include patients who have never had an index arrhythmia, but instead have been implanted with an ICD to avoid their first arrhythmia ("primary prevention").In American society, there is a constant conflict between the rights of the individual and the good of society. The individual is given the right to act in whatever manner he or she chooses as long as that act does not impinge on the rights of others. The latter requirement demands that limits be placed on the rights of the individual just as limits are placed on the rights of society to restrict individual action. Ethics tries to address the delicate balance between these two conflicting principles. In American society, individual mobility and access to education, employment, health maintenance, and personal enrichment opportunities are highly dependent on the automobile. Being unable to drive puts limitations on the individual, which results in both emotional stress and loss of economic status. At the same time, the citizens of a society have the right to protect themselves against the harm caused by individuals who are unable to operate a motor vehicle in a safe and prudent manner. In a just and open society, all individuals are treated equally. Therefore, restrictions on the driving ability of patients with arrhythmias must be clearly elaborated and applied uniformly to all.Okay, okay, but I have a bit of a problem with the last sentence of this paragraph. Is there no line to be drawn for the evaluating physician? But even harder to swallow was this paragraph:
The physician and other healthcare professionals are bound to uphold the confidentiality of information regarding a patient’s medical condition, and such information is shared with others only when consent is given by the patient. If a patient requests that medical information be withheld from his or her employer, the ethical physician will not comply with the patient’s request if doing so would pose a risk to others. In such instances, the patient should be asked to release this information. If, however, the patient does not agree, the physician is bound to breach confidentiality. Although breaking the principle of confidentiality may result in legal action by the patient against the physician, the ethical responsibilities of beneficence (“do good and avoid evil”) and nonmaleficence (“do no harm”) take precedence over the principle of confidentiality in this setting. In such situations, the ethical course is for the physician to release the required information to the proper authorities, such as the state or national departments of transportation, while providing full disclosure to the patient.In effect, we get to be tattle tales in the interest of public safety. So much for your confidentiality. And this will be in spite of this tidbit of data:
Patients randomized in the AVID Trial reported resuming driving early regardless of medical advice to the contrary (80% were driving within 6 months), reported driving frequently (57% reported driving every day), and reported driving significant distances (25% were driving 100 miles/wk). However, these patients, who had survived a near-fatal episode of ventricular arrhythmia, had a very low rate of automobile accidents. Indeed, the frequency of automobile accidents (3.4% of patients per year) was less than that of the general driving population of the United States (7.1% patients per year). Nevertheless, the relatively high event rate soon after the index episode of ventricular tachyarrhythmias led to a suggestion that driving be restricted for all patients for 1 month and for most patients up to 8 months after such an event.I agree with the task force's opinion that driving in primary prevention patients be restricted from driving for a week after a new implant, but asking patients to avoid driving for 6 months after they've had a significant arrhythmia in all cases seems excessive, specially if a precipitating cause (ischemia, heart failure, drug effect or device programming error) is identified.
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.Anyone remember the alternate fat Olestra that stayed in your gut and caused, well, er, "anal leakage?" Look for Alli to be your ally in not only losing weight, but also treating constipation with interesting side effects (Medline Plus Drug Information):
The most common side effect of orlistat is changes in bowel movement (BM) habits. This generally occurs during the first weeks of treatment; however, it may continue throughout your use of orlistat. Tell your doctor if any of these symptoms are severe or do not go away:How bad can this be? Just look at this hilarious post from Craig's List "Best of" Series regarding Pringles Fat-Free Potato Chips (warning, contains profanity). You might want to rethink how many pills you'll take!
- oily, spotting BMs
- gas with discharge
- urgent need to have a BM
- oily or fatty stools
- an oily discharge
- increased number of BMs
- inability to control BMs
- orange or brown color of a BM
- stomach pain
- irregular menstrual periods
More than most other professions, medicine has the ability to devour all it touches. Those who enter the world of medicine as patients soon find it difficult to identify themselves beyond the confines of their label-- at least within the walls of the hospital. Those who enter into it as a career soon discover just how far-reaching a life in medicine is. Interests and relationships that once defined us as people too often take a backseat to the demands of medicine. Too easily we find that we lose sight of ourselves. We advise patients to rest, exercise, eat right, deal with stress, develop good coping mechanisms... and then we go home, order out, catch up on paperwork and try to fit in a few moments with our loved ones before catching a few hours of sleep.Enjoy!
..."the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.This could spell more bad news for Johnson and Johnson and Boston Scientific if further cuts in reimbursement for drug-eluting stents are implemented.
Abstract: In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.This study was sponsored by Johnson and Johnson. What the effect on long-term clopidogrel therapy, recently recommended to prevent the late in-stent thrombosis of drug-eluting stents has on these "off-label" patients, especially after nine months (when in-stent thrombosis is seen), remains untested. Look for significant positioning by these companies to continue the status quo.
New York Times, 5/24/05: “Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw that, while rare, poses potential dangers. Also, companies are not required to report immediately all safety modifications to the Food and Drug Administration.”The cases regarding this recall and others are still winding through the courts, and will be for some time to come. St. Jude, too, had their own recall that year as well. In all, over 100,000 patients were affected by a recall or advisory condition about their device that year. Companies realized that there could be significant risks with keeping the public uninformed about known flaws in the design of their devices. They hurried to inform physicians and patients about their concerns, leaving doctors to notify their patients and try to determine the best course of action with very little real information. These concerns lead the Heart Rhythm Society, in conjunction with physician, patient, government and industry input, to issue new device performance policies and guidelines regarding notification of physicians and patients. A new defibrillator registry was also implemented to track currently implanted devices to determine the incidence data of defects with defibrillators.
CNNMoney.com 30 Jan 07 3:22PM: The Minneapolis-based device maker put 11,000 Concerto devices on the U.S. market after the FDA approved it in May of 2006, said Medtronic spokesman Robert Clark. But Clark said the FDA has not discussed the investigation with Medtronic.I called David Steinhaus, MD, Director of Cardiac Rhythm Management at Medtronic in an attempt to better understand the situation and see if they felt there issues I should know about with their device. He returned my call the next day and reassured me that there were no issues with any of the 11,000 devices implanted to date. He referred me to this news release from Ms. Rebello, issued later the same day as the earlier press releases, that “all is well.” Everything’s been checked. We’ve looked into it, really. Medtronic tells us that over 11,000 devices have been implanted and no patient safety issues have occurred. Really. It’s fine. Nothing to worry about. They’ve checked the manufacturing plant – its fine. They’ve reviewed their FDA submission and their data – it all looks good:
"Medtronic has not been contacted by the FDA in regards to an investigation in this matter," said Clark.
"The agency has completed a thorough investigation of the charges. To date, FDA has found nothing that would have influenced its decision to approve this device." Rebello added the investigation included a scientific review of the employee's allegations, an inspection of the company's manufacturing facility and a review of various available data. "All of this information was analyzed with respect to whether or not the allegations identified a safety concern for patients that substantively altered the risk/benefit profile for this device," she added.We can only hope for such governmental efficiency in all of our agencies: the ability to achieve complete clarity in a matter of hours. What, exactly, can you clarify in a few hours – the data or the spin? If everything was wrapped up, why didn’t they tell us this with the first press releases? And what does the term “substantively altered the risk/benefit profile for this device” mean, really? Did they find something that looked “risky?” If so, what was it?
Reuters Jan 30,2007 @ 6:49PM: Medtronic said it has had no reports of patient safety issues related to the wireless features of the device.Then I checked the FDA database for Concerto-related injuries myself and found this. Since I cannot determine the nature of this device’s defect, I am left to wonder: could this have been caused by one of the ex-Medtronic engineer’s concerns? And regarding Medtronic’s knowledge of an FDA inspection: did they know about the FDA inspection of their manufacturing facility or didn’t they? Why not level with me, one of their biggest advocates?
Review of our worldwide experience to date has identified only one (actual number) of 11,012 implanted devices (give the actual number here) that has demonstrated device malfunction with compromised therapy. This failure rate falls well below the anticipated incident rate of annual failures of 20.7 per 1000 devices implanted annually for such devices outlined by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. We are investigating/have investigated the root cause of this malfunction. (Explain what was/was not found here). We do/do not feel this device malfunction is related to the concerns raised by our former employee.But this is not what was said. Instead we were obfuscated with PR-speak. “We are investigating” became “we found nothing” in less than 24-hours. Well if I could find one injury on the FDA’s own database, how hard did the FDA look?
