Category Archives: Policy & Ethics

Rivaroxaban Gains Approval In Europe For ACS Indication Reply

by • MI/ACS, People, Places & Events, Policy & Ethics • Tags: , , , , ,

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an ACS indication.

The approval is based on data from the pivotal ATLAS ACS 2-TIMI 51 trial. In the United States, where Xarelto is marketed by Johnson & Johnson, the FDA has twice rejected an ACS indication for rivaroxaban.

The new indication joins the already-approved indications for higher doses of rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery, for the treatment of, (and prevention of recurrent) DVT and PE, and for stroke prevention in patients with atrial fibrillation.

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” said C. Michael Gibson, the Principal Investigator of the ATLAS ACS2-TIMI 51 trial, in a Bayer press release. “This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”

 

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Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated.

But at least one source of fierce criticism won’t be participating in the panel. Steve Nissen, who originally raised concerns about the drug and who has remained the most consistent critic of the drug, will not participate in the deliberations or present to the committee. Early on Thursday Nissen contributed a blog post on Forbes accusing the FDA of stacking the committee in favor of rosiglitazone. The FDA leadership, he says, is trying to use the meeting to “whitewash” its reputation:

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GlaxoSmithKline said that “many inaccuracies exist in Dr. Nissen’s commentary and need to be addressed.” The company specifically denied the multitude of reports over the years that it had suppressed negative data about rosiglitazone over the years. The GSK response offers one potentially very important piece of news. The main focus of the June 5-6 hearing will be the re-adjudication of the RECORD trial performed by the Duke Clinical Research Institute. No public disclosure of the results of the re-adjudication have been made, and in the normal course of events the details of the re-adjudication, along with the rest of the committee’s briefing documents, would appear two days before the start of the hearing on the FDA website. But FDA staff, advisory panel members, and the drug sponsor (GSK) have almost certainly already seen the re-adjudication. In its statement, GSK flatly states that the re-adjudication confirms the safety of rosiglitazone:

The RECORD study is the largest clinical trial designed to evaluate the cardiovascular safety of Avandia. The study conclusions have now been confirmed through a re-examination by one of the leading independent institutions in the country (Duke Clinical Research Institute). In the accepted hierarchy of evidence generation, the results of a randomized, controlled clinical trial usually take precedence over other forms of evidence such as meta-analysis and observational studies. Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time. The confirmation of the RECORD results by the independent re-examination support a positive risk/benefit profile for Avandia for the treatment of type 2 diabetes in appropriate patients.

It remains to be seen whether this is more RECORD spinning or an accurate summary of the Duke re-adjudication.

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Click here to read the full story on Forbes.

 

Deutsch: Tonabnehmer eines Plattenspielers

 

Novartis Acknowledges Employees Participated In ‘Independent’ Trials Reply

by • People, Places & Events, Policy & Ethics • Tags: , , , ,

Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five trials.

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The new statement from Novartis admits that “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator initiated valsartan trials in Japan.” The statement also disclosed that “a second former employee (who reported to the first former employee) had involvement which was limited to one of these trials.” Novartis said that independent investigation is continuing but that so far there has been no indication of a “specific company strategy to integrate the first former employee into the five valsartan investigator initiated trials.” However, the investigation has revealed

that some of this former employee’s superiors in Japan knew of his participation in these trials and were supportive of him in these activities. They believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising. In addition, there is no indication that any of his supervisors knew or approved of the incomplete disclosure of his affiliation in the published papers for these studies.

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Click here to read the full story on Forbes.

 

İsviçre Basel'deki Novartis binası

 

 

Small Study Suggests Statins May Blunt Benefits Of Exercise 1

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

A small study is raising big questions about whether statins may blunt the beneficial effects of exercise. The study has been published online in the Journal of the American College of Cardiology and was the subject of a New York Times blog today.

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The authors concluded: “Given the strong independent cardio-protective effects of increasing cardiorespiratory fitness or lowering LDL, the benefits and risks of each should be carefully considered when choosing treatment modalities.”

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Click here to read the full story on Forbes.

 

John Thyfault

 

Athletes With Defibrillators Don’t Need To Quit Sports Reply

by • Heart Rhythms, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , ,

Although the American College of Cardiology and the European Society of Cardiology now advise people with ICDs not to participate in vigorous sports, a new study offers strong support for people with ICDs who want to take part in sports. Although a large number of people with ICDs are elderly heart failure patients who are unlikely to want to participate in sports, ICDs are also implanted in young and otherwise healthy people with genetic diseases that leave them at high risk for lethal arrhythmias.

Now findings from the ICD Sports Safety Registry, published in Circulation, provide vital new information about this important topic. The registry, which was performed with the assistance of patient advocacy groups, included 372 ICD patients between 10 and 60 years of age who participated in sports more vigorous than golf or bowling. The most common reasons for having an ICD among people in the registry were long-QT syndrome in 73 people, hypertrophic cardiomyopathy in 63 people, and arrhythmogenic right ventricular cardiomyopathy in 55. 60 subjects were college age or younger who took part in competitive sports.

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Click here to read the full post on Forbes.

 

HOLLAND, MI - MARCH 7: Fennville High School ...

 

European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System 1

by • Heart Failure, People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure.

The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent.  A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that ”although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events… The risk to benefit ratio argues against the use of dual therapy.”

Franz Messerli, senior author of the BMJ meta-analysis, applauded the EMA action and said that “as usual the FDA is dragging its feet.”

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Click here to read the full story on Forbes.

 

 

 

Similar Cardiovascular Risk Observed With COPD Drugs Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: ,

A large observational study has found no difference in the increased risk for cardiovascular disease between the two main classes of drugs used in the first-line treatment of chronic obstructive pulmonary disease (COPD). LABAs (long-acting inhaled beta-agonists) and LAMAs (long-acting muscarinic antagonists) have a variety of beneficial effects in COPD patients, but evidence has been building that these agents may produce a small but significant increase in cardiovascular risk.

In a new study published online in JAMA Internal Medicine, Andrea Gershon and colleagues analyzed data from nearly 200,000 elderly COPD patients from Ontario, Canada. 28% of the group had a cardiovascular event.

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Click here to read the full post on Forbes.

 

Salt Report From IOM Sparks Much Heat, Only A Little Light Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

An Institute of Medicine report on salt earlier this week sparked a lot of controversy. The report concludes that there’s no evidence to support current efforts to lower salt consumption to less than 2,300 mg/day. Unfortunately, the press coverage offered little insight into the science behind the issue. On the Knight Science Journalism Tracker blog, Faye Flam deftly uncovers the almost universal shallow coverage in the media.

The one exception, the one story worth reading that “dug into the science,” according to Flam, is Gina Kolata’s story in the New York Times:

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Click here to read the full post on Forbes.

 

English: A close up of salt crystals.

Our Limitless Capacity For Self-Deception 10

by • Policy & Ethics • Tags: , , ,

I want to share with my readers a recent post and accompanying comment published on CardioExchange. The original post is by Eric Lindley, a cardiology fellow at the University of Utah:

Journal X: Not so Subtle Marketing Messages

I was the rare resident who thought that conflict of interest issues in medicine were a bit overblown. I did not find (or ignored) the evidence that pharma played a role in prescribing habits very persuasive, at least not when it came to my personal prescribing habits. I was not alone among the house staff, however, in appreciating an occasional “free” lunch, and the much rarer sponsored dinners at places I couldn’t afford as a physician-in-training.

Now I’m a fellow, and my attitudes about the pervasiveness of pharma influence have changed. Am I older and wiser? I’d like to think so. But I owe most of my conversion to the fresh perspective of my three-year-old daughter. She refers to most things by their color, including a majority of my medical journals. For instance, my JACC journals: blue for the mother journal, red for heart failure, green for interventions, etc. But then she started calling the original JACC the “X” journal. When I asked her why, she pointed to the “X” in Xarelto (rivaroxaban). I realized that every issue of JACC is covered front to back with the “X”. The message was subliminal to me, but quite obvious to her.

How do you think all of our pharma marketing looks with naive eyes?

This post prompted the following response from Siqin Ye, a cardiology fellow at Columbia University:

A story that I heard at ACC a few years ago goes something like this:

In a roomful of interventional cardiologists, the speaker asks, “How many of you have ever put in a stent that was unnecessary?”

Two or three hands went up.

The speaker then asks, “How many of you have seen someone in this room put in a stent that was unnecessary?”

About half the room raised their hands.

I think there is something similar with respect to our attitude towards pharma ads and gifts. I know plenty of residents and fellows who firmly believe that ads and dinners do not affect their personal practice patterns. Whether or not this is true for any given individual, the fact that pharma continue to spend so much on these activities suggest that as a whole, we are probably more susceptible than we believe.

 Thanks to Drs. Lindley and Ye for permission to reprint their words.

 

Suspicions Raised About Another Japanese Cardiovascular Researcher Reply

by • People, Places & Events, Policy & Ethics • Tags:

Significant questions about research misconduct have been raised about a prominent Japanese cardiovascular researcher, Issei Komuro.

Last year a Nature paper on which Komuro served as a co-author was corrected because “several images were mistakenly switched or duplicated during preparation of the artwork.” The Nature correction states that the “corrections do not alter any of the conclusions” of the paper. Now, however, a Japanese blog, entitled Issei Komuro – image manipulation -, raises questions about 13 additional papers. The papers were all published in well-known journals, including a second Nature paper, Nature Medicine, and 4 separate papers in Circulation. On many of the papers Komuro served as the senior author.

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Click here to read the full post on Forbes.

 

 

Encouraging 4 Year Results For Watchman Device In AF Patients Reply

by • Heart Rhythms, Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , ,

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.

Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.

Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in  2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).

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Click here to read the full story on Forbes.

 

 

 

FDA Approves Combination Of Ezetimibe And Atorvastatin Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , , ,

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.

Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol from 53% to 61%, depending on dosage.

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Click here to read the full post on Forbes.

 

Scrutiny Of Sodium Meta-Analysis In Heart Uncovers Duplicated And Missing Data Reply

by • People, Places & Events, Policy & Ethics • Tags: , , ,

A meta-analysis published in the journal Heart has been retracted. As Adam Marcus writes in Retraction Watch, the retraction occurred when the journal editors learned “that two of the six studies included in the review contained duplicated data.  Those studies, it so happens, were conducted by one of the co-authors [of the meta-analysis].”

The article, “Low sodium versus normal sodium diets in systolic heart failure: systematic review and meta-analysis,” was published online in August 2012. In their attempt to investigate the duplicate data, the Heart editors reported “that the raw data are no longer available having been lost as a result of computer failure.”

The authors of the meta-analysis were James J DiNicolantonio (Wegmans Pharmacy, Ithaca, NY), Pietro Di Pasquale (Chief Division of Cardiology, “Paolo Borsellino”, G.F. Ingrassia Hospital, Palermo, Italy),  Rod S Taylor (Peninsula Medical School, University of Exeter, Exeter, UK), and Daniel G Hackam (University of Western Ontario and the London Health Sciences Centre, London, Ontario, Canada).

It was the second author, De Pasquale, who was the co-author of the duplicated papers that also contained the missing data.

You can read the entire story in Retraction Watch. Don’t miss the comments. Here’s one:

“computer failure” is the scientist’s version of “the dog ate my homework”

 

heart cover may13

Japanese Research Scandal Expands To A Second Trial And A Novartis Employee Reply

by • People, Places & Events, Policy & Ethics • Tags: , , , , ,

A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal.

Now, however, questions have been raised about  another clinical trial, the Jikei Heart Trial, which was published in the Lancet in 2007.  (Matsubara was not involved in this trial.) Novartis, which manufactures valsartan (Diovan), the drug studied in both trials, has announced that it is investigating both trials in response to new allegations that a Novartis employee worked on the trials without any disclosure of his company affiliation.

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Click here to read the full story on Forbes.

Danish Study Finds No Increased CV Risk With Azithromycin In General Population Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published  in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls who took no antibiotics and with matched controls who took penicillin V for similar indications.

Although there was a significant increase in the risk of death from cardiovascular causes in people taking azithromycin compared with people taking no antibiotics (RR 2.85, CI 1.13 – 7.24), there was no increase in risk when compared to people taking penicillin V (RR 0.93, CI 0.56 to 1.55). The findings, write the authors, indicate “that the increased risk that was observed in the comparison with no antibiotic use was entirely attributable to the risk of death associated with acute infection (or some other adverse health characteristic in persons receiving antibiotic treatment, as compared with those not treated with antibiotics) rather than with its treatment.”

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Click here to read the full story on Forbes.

FDA Warns That Tolvaptan Can Lead To Serious Liver Injury Reply

by • Heart Failure, People, Places & Events, Policy & Ethics • Tags: , ,

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. “

The liver injury risk was discovered in clinical trials testing tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). The drug label has been updated and now states that use of the drug should be limited to 30 days and that it is no longer indicated in patients with cirrhosis. The FDA recommended that tolvaptan should be discontinued in patients with liver disease who are currently taking the drug.

 

 

WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

There’s probably no greater public health issue than the long-term  consequences of the childhood obesity epidemic. So the Wall Street Journal should be commended for digging into some of the important science behind this problem in a feature article in today’s paper. The author, Ron Winslow, is widely regarded as the best working journalist who regularly covers cardiovascular medicine. But I’m afraid the article fails to raise several key questions about the topic and therefore misses an opportunity to educate people about its complexities.

The article deals with the “growing concerns about the cardiovascular health of millions of children in the U.S. who are considered obese or overweight” and then focuses on one recent study published in Pediatrics that “suggests there is a simple way to assess a child’s arterial health with a calculation based on an often-overlooked component of cholesterol: triglycerides.” Winslow faithfully reports the main finding of the study, which is that the triglyceride to HDL ratio corresponds closely with arterial stiffness. A stiff vessel is a sign of “accelerated aging” and “likely raises the risk of dangerous outcomes relatively early in adult life,” writes Winslow.

Winslow notes that an NHLBI panel now recommends universal cholesterol screening for children between 9 and 11, but there is no mention that some experts disagree with this recommendation.  Further, these screening tests focus on the measurement of LDL cholesterol. Winslow doesn’t discuss whether  LDL would be equally effective as triglycerides and HDL at identifying children with stiff arteries. Winslow writes, reasonably, that high triglycerides and low HDL “are a hallmark reflection of the poor diets and sedentary lifestyles that researchers say are behind the wide prevalence of obesity among both children and adults,” but there’s a big gap between that association and concrete recommendations to measure HDL and triglycerides in children and, more importantly, to take actions based on these measurements.

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Click here to read the full story on Forbes.

scale_zero

Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised 1

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , ,

Here are two small but important changes in the anticoagulation field:

FDA approves new product for urgent reversal of anticoagulation. 

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Pradaxa label gains boxed warning.

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Click here to read the full story on Forbes.

 

English: Logo of the .

 

Unconventional Analysis Finds Threshold For LDL Reduction With Statins Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

Using an unconventional mathematical approach, a group of Japanese researchers say there may be no good reason to reduce LDL cholesterol more than 40 mg/dl. Their research letter has been published online in JAMA Internal Medicine.

According to the authors, members of the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group, most meta-analyses use linear models that assume “a constantly increasing or decreasing risk as the exposure increases or decreases.” Linear models, however, can be “misleading,” they write, because they assume a specific dose-response relationship. By contrast, their new analysis utilizes “flexible” models that can more readily uncover “threshold effects.”

Click here to read the full post on Forbes.

 

Edwards CEO Sold Stock 2 Weeks Before It Tanked 2

by • Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , ,

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed at 65 on Thursday.

But Edwards chairman and CEO Michael Mussallem didn’t suffer along with his shareholders. As reported by GuruFocus, Mussallem sold 35,000 shares of his stock on April 10 at 83.37 per share netting him nearly $3 million. Another executive, the corporate VP of Japan and Intercontinental, Huimin Wang, sold 4,850 shares at $81.74 per share.

The dramatic drop in Edwards’ stock is another sign that the market for transcatheter heart valves has not grown as rapidly as many had expected. “Edward’s initial 2013 guidance clearly proved to be overly aggressive on U.S. TAVR sales as capacity constraints and the complexities of bringing a 20+ person team up the learning curve clearly tempered the adoption curve more than expected,” said a Leerink Swann analyst quoted by Bloomberg.

Update: I have been informed by Edwards that the recent sale was part of a predetermined plan to sell shares. Mussallem has sold 35,000 shares each month since June of 2012.

Actelion Executive To Head American College of Cardiology Reply

by • People, Places & Events, Policy & Ethics, Uncategorized • Tags: , ,

Shalom “Shal” Jacobovitz will be the new chief executive officer of the American College of Cardiology, the ACC announced today. Jacobovitz is currently the president of the US division of Actelion Pharmaceuticals, best known for its pulmonary hypertension drugs.

Click here to read the complete story on Forbes.

Shalom Jacobovitz

 

The FDA, Surrogate Endpoints, And Blood Pressure Drugs Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , ,

In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpoint– including cholesterol and other lipids, blood glucose, weight loss, and blood pressure.

Despite what some believe is a long-term trend against the use of surrogate endpoints, the FDA is actually seeking to make it easier for manufacturers of one therapeutic category, antihypertensives, to claim cardiovascular benefit for their drugs despite the absence of evidence to support most of these drugs.

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Although the actual changes proposed by the FDA are small, I thought the issue bore further exploration. I first spoke with Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products (DCaRP) in the Office of Drug Evaluation 1 at the FDA. I then asked Harlan Krumholz, Sanjay Kaul, and Franz Messerli and Sripal Bangalore to comment on this topic.

Click here to read the full article on Forbes.

Harlan Krumholz

Sanjay Kaul

Advice For Physicians: How To Behave Online Reply

by • People, Places & Events, Policy & Ethics

Although the internet represents “a new frontier in medicine” for physicians and patients it also presents numerous and novel challenges to professionalism, according to a position paper from the American College of Physicians and the Federation of State Medical Boards published in Annals of Internal Medicine.

The paper offers physicians a new conceptual “framework for analyzing medical ethics and professionalism issues” on the internet and provides recommendations for physicians on the use of email, blogs, social media sites, and more.

When communicating with patients, physicians should “consistently apply ethical principles for preserving the relationship, confidentiality, privacy, and respect for persons to online settings and communications.” The authors note that “the ease of use and immediacy of social media tools… can lead to unintended outcomes or messages.” They recommmend “pausing before posting” and warn about the potential dangers of “patient-targeted Googling.”

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Click here to read the full post on Forbes.

A traffic controller holds a go slow sign on a...

 

More Reasons Why Health Hype Stories Are Bad Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

In response to my post yesterday about why health stories should nearly always be received with caution, I received the following comment from a distinguished cardiovascular researcher:

One lost point is the role of the investigators and media in hyping their research. Hazen (principal investigator of the first study) is a bright and thoughtful guy, but through the Cleveland Clinic PR department, his nice hypothesis-generating research got turned into the missing link between red meat and heart disease, which obviously is a huge leap. The paper itself is much more measured than the press release and subsequent coverage. Same for the carnitine meta-analysis It is a meta-analysis of small studies published in a 3rd tier medical journal. I haven’t read the original article, but I bet it is pretty measured in its discussion and conclusion. But then comes the press release and the media, and boom, we have a cure for heart disease that conflicts with a cause for heart disease. Both studies are hypothesis-generating and non-conclusive. They are important additions to our medical knowledge base, but offer nothing for the public right now.

So here I blame the PR departments, but the investigators go along with this, so they get some of the blame, as well as the media who hype it. By the way, from the standpoint of the investigators, the institutions, and the journals they published in, this media frenzy was considered a huge success. For the rest of the medical community and the patients, it was a nuisance, a distraction, led to confusion, and then phone calls to doctors.

Hype shot glass

I’d like to offer one additional caveat about the L-carnitine metaanalysis. This is a perfect example of a topic that might be seriously distorted by publication bias. In other words, a potentially important finding– in this case, a result showing that carnitine is beneficial after a heart attack– is much more likely to be published than a negative finding. This doesn’t mean that the metaanalysis is necessarily wrong, but it does provide yet another reason why we should always be careful when looking at studies like these.

 

 

Related articles

FDA Schedules Another 2 Day Avandia Advisory Panel Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  ”discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”

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Click here to read the full story on Forbes.

 

Recording vinyl to CD

 

Partial Rosiglitazone/RECORD Chronology