Category Archives: People, Places & Events

Instagram for Heart Attacks: iPhone App Speeds ECG Transmission To Hospital Reply

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

In the crucial early stages of a possible heart attack, EMTs on the scene now rely on slow and unreliable proprietary technology to transmit vital ECG data to physicians at a hospital for evaluation. But a new iPhone app using standard cell phone networks may help speed the process and, ultimately,  cut delays in treatment for heart attack patients.

In a presentation earlier today at the American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions 2013 meeting in Baltimore, faculty and students at the University of Virginia designed an iPhone app to overcome some of the limitations of the current system. The iPhone app takes a photo of the ECG, reduces its size, and transmits the image over a standard cell phone network to a secure server. The image can then be viewed at the receiving hospital by physicians qualified to read an ECG.

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Click here to read the full post on Forbes.

Opening Screen of the iPhone App
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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.

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.

 

 

Burton Sobel, Towering Cardiologist, Dead At 75 Reply

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

Burton Sobel, a towering scientist and cardiologist, died at home on May 3 at the age of 75. Sobel had been treated in the past for prostate cancer and had suffered a recurrence, but it is not known if this was the immediate cause of his death.

Sobel was among the most powerful and influential cardiologists in the 1980s when he played a key early role in the development of fibrinolysis and the first major biotechnology product, TPA. From his perch as the chief of cardiology at Washington University in Saint Louis and as the editor of Circulation, Sobel was a member of a small group of cardiologists who set the agenda for cardiology and moved the field forward. The group, which also included James Willerson, Myron Weisfeldt, and Eugene Braunwald, was “innovative” and “visionary,” said Allan Jaffe, who worked closely with Sobel at Washington University for many years. “It was a very exciting time in cardiology,” he said.

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Click here to read the full post 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.

 

 

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 .

 

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.

Another Cleveland Clinic Study Links TMAO To Atherosclerosis Reply

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

A new study from the Cleveland Clinic research group headed by Stanley Hazen offers more evidence in support of the hypothesis that TMAO (trimethylamine-N-oxide) may play a role in the development of heart disease. The new research, published in the New England Journal of Medicine, follows closely on a related study published recently in Nature Medicine that received broad public attention.

The Nature Medicine paper demonstrated that digestive tract bacteria metabolize carnitine into trimethylamine-N-oxide (TMAO), which had previously been linked to atherosclerosis in animals. The new research in NEJM focuses on another pathway that leads to TMAO production and provides for the first time a credible association between TMAO and cardiovascular disease in humans.

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Click here to read the full story on Forbes.

Stanley Hazen

 

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

Is Red Meat A Fish Story? Why You Should Never Believe Health Headlines 2

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

Don’t believe the the hype! That’s the cardinal rule to obey when reading health news. “Breakthroughs” and “cures” are rare, and should always be viewed with caution and skepticism.

This week was a great example. Last Sunday, the New York Times, the major networks, and a host of other media outlets (including this one) reported on a paper in  Nature Medicine about the discovery of a novel and potentially significant pathway linking red meat to heart disease. Briefly, the research suggested that carnitine, which is found naturally in high concentrations in red meat, can lead to atherosclerosis when it is converted by gut bacteria to a chemical called TMAO. Almost immediately I received a lot of comment from experts who raised serious questions about the research. Then today, a separate study was published with an entirely different perspective on carnitine. Although the two studies don’t directly contradict each other, they suggest that the real truth about carnitine is likely to be quite complex and will never be adequately summarized in a headline.

Click here to read the full story on Forbes.

Hype shot glass

 

Scientific Misconduct: From Darwin And Mendel To Poldermans And Matsubara Reply

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

Responding to recent episodes of scientific misconduct in cardiovascular research involving once prominent cardiovascular researchers, the editor of the European Heart Journal, Thomas Lüscher, has written an editorial discussing the significance of the new cases and placing them in a historical context that includes allegations of scientific misconduct by Mendel and Darwin, among many others.

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Poldermans was the first or the senior author in 7 papers published in EHJ. Lüscher writes that the chairman of the Poldermans investigative committee “made it clear that the vast amount of publications led by Poldermans over the last decades made it impossible to assess their scientific validity in all cases.” As a result, Poldermans announces that “the editors of the European Heart Journal therefore would like to make an expression of concern related to the papers where Poldermans was the responsible author.”

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Comment: Without more information there will continue to be a large cloud of uncertainty hanging over the cardiovascular literature. The statement of the chairman of the Poldermans committee bears repeating: “the vast amount of publications led by Poldermans over the last decades made it impossible to assess their scientific validity in all cases.”

 Click here to read the full story on Forbes.

 

Gregor Mendel
Gregor Mendel

 

Don Poldermans

 

 

 

 

FDA Approves First SGLT2 Inhibitor For Diabetes 1

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

The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes including metformin, sulfonylurea, pioglitazone, and insulin.

Click here to read the full post on Forbes.

English: Logo of the .

79-Year-Old Cardiologist Sentenced To 6 Years In Prison For Fen-Phen Fraud Reply

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

A 79-year-old Florida cardiologist has been sentenced to 7 years in prison for his participation in the Fen-Phen fraud, according to a report by John Martin on Philly.Com. The article notes that other cardiologists have been convicted for similar reasons in the Fen-Phen case, but Tai’s case is unusual because of the length of the sentence.

The cardiologist, Dr. Abdur Razzak Tai, was convicted last September. Here is how the US Department of Justice summarized the case at the time:

Between 1997 and 2009, Tai… reviewed the echocardiograms of more than 1,100 patients who filed claims with the American Home Product Settlement Trust in Philadelphia and falsely certified that the patients’ tests showed that they had sustained heart damage. In reality, many of those claimants had not been harmed.

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Click here to read the full story on Forbes.

Português: Uma cela moderna em Brecksville Pol...

Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension Reply

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

For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA.

“We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner,” said the company’s chairman and CEO.

Treprostinil is a prostacyclin vasodilator that is already approved for the treatment of PAH in an injectable form (Remodulin) and in an inhalable form (Tyvaso). The FDA initially rejected the NDA for the drug last October.

 

Embers Of Poldermans Case Still Smoldering Reply

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

Don Poldermans

A prominent US cardiologist has rebuked Don Poldermans, the cardiovascular researcher at the center of a research scandal in the Netherlands. As reported here previously, Poldermans was fired for scientific misconduct by the Erasmus Medical Center in Rotterdam, where he had been a professor of medicine and the head of perioperative cardiac care. He was widely published and active in the field, serving as a member of the European Society of Cardiology committee for practice guidelines and as the chairperson of the ESC guidelines on pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery. He was also the lead author of the influential (but controversial) 1999 New England Journal of Medicine DECREASE study on the use of bisoprolol during vascular surgery. An investigation at Erasmus found that Poldermans used patient data without written permission, used fictitious data, and submitted two reports to conferences which included knowingly unreliable data.

The new episode has its origins in a review article published last October by prominent cardiologist University of Michigan cardiologist Kim Eagle, and a colleague, Vineet Chopra, in the American Journal of Medicine. The article, “Perioperative Mischief: The Price of Academic Misconduct,” discusses the “caustic” effects of the Poldermans case, noting the dilemma facing clinicians “now that a considerable portion of the literature is enshrouded in uncertainty.” Now (as first reported by Retraction Watch) Poldermans and the Michigan cardiologists have exchanged letters in the April issue of the journal.

In his letter responding to Eagle and Chopra’s review article, Poldermans is critical of the Michigan authors for accusing him of “scientific fraud.” Poldermans acknowledges in his letter that he made various mistakes, including failure to obtain written informed consent and “negligent” data collection. He denies, however, that he fabricated data or published any results based on the compromised data. He writes that Eagle and Chopra assumed he was guilty despite the fact that the final report from the Erasmus Medical Center had not been released. He notes that in the final report Erasmus had concluded that “no evidence was found for any manipulation of the research results by the researchers in the sense of deliberate steering of results into a particular direction.”

In their response, Eagle and Chopra said that in their article they had stated that the accusations of fraud were still allegations. More importantly, Poldermans missed the larger point of their paper:

Click here to read the full story on Forbes.

Kim Eagle

Kim Eagle

 

 

 

CHMP And FDA Diverge On Mipomersen And Rivaroxaban Reply

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

The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected– for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the same indication. In contrast, although the FDA recently approved the new cholesterol-lowering agent mipomersen (Kynamro, Isis and Genzyme), CHMP, after reviewing its previous negative position, reaffirmed today that it would not recommend approval of the drug in Europe.

Click here to read the full post on Forbes.

 

European Medicines Agency

 

The PREVAIL Fail Revisited: Spinning The Truth 1

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

SPIN
The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.

To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before that I think holds the key to a full understanding of the story.

More than a week before the scheduled presentation I received an email invitation from a PR firm representing Boston Scientific:

“If you have any interest in speaking about the trial under embargo with Dr. Ken Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific, I have a few slivers of availability early next week. As you know, the embargo lifts at the time of presentation and I’ll need written confirmation of your embargo agreement.”

Now I’ve been down this road before, as some of you may recall. Several years ago I was offered embargoed access to data from an important upcoming trial by Medtronic (suggesting that this is a systemic problem) under the condition that I agree to a briefing from a trial investigator. I told the company that I would respect the embargo but that I wanted to review the data on my own and that I would get back to them if I had any questions. Their response: no briefing, no data.

Here’s the problem in both cases: forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system.

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Click here to read the full post on Forbes.