February 19th, 2013
‘So, Doctor, How Bad Is It?’
Reva Balakrishnan, MD, MPH
While on my Electrophysiology rotation, I was asked to interrogate an ICD of a patient who had received a shock from her device the night prior to admission. I performed the interrogation, confirmed that it was an appropriate shock for VT, noting that multiple appropriate shocks had occurred in the preceding months. As I was leaving the patient’s room, I was stopped by a family member.
“So, doctor, how bad is it?” she asked.
I knew only that the ICD was placed for primary prevention in the setting of heart failure with a depressed ejection fraction several years ago, and that this was the first time the device had fired since it had been implanted, and that the patient had been admitted in decompensated heart failure.
With concern in her voice, she continued, “She was doing ok before this; what does this mean and how much time does she have left?”
I was caught off guard and I hesitated for a moment, trying to think of the right words to say regarding a delicate issue about which I did not have enough information to address. As I thought of a response, I couldn’t help but think about what we have learned from long term follow up studies of the large ICD trials (such as MADIT and DINAMIT) – that although ICD’s deliver life-saving therapies, the people who do benefit from those life-saving therapies have been shown to have a significantly decreased survival after therapy compared to those who never receive them. At the same time, I also remembered that every patient is an individual, so that finding may not necessarily apply in any particular case.
I acknowledged their concern, but given that I was only peripherally involved, I asked them to wait to speak with the primary cardiologist who had been involved in their family member’s care for a long time. As I walked away, I couldn’t help but feel some relief in avoiding the complexities involved with addressing the “prognosis” question; but I was left with a lingering unease. I kept thinking, if this truly had been my patient, what would I say if I had been asked how long this patient had left to live?
Several years ago when I was deciding on subspecialty fellowship training, one of the many reasons why cardiology was so appealing to me was the incredible capability of being able to save people’s lives while also maintaining their quality of life– either with live-saving PCI during STEMI, medical optimization in heart failure, or even bi-ventricular ICD implantation. Our training and practice is built on the backbone of “best evidence” from trials with thousands of patients that have shown us how to improve morbidity and mortality in patients with cardiovascular disease. But what happens when our interventions don’t work anymore? What happens when our patients arrive at that tail end of the survival curve?
In fellowship, the emphasis of our training is often focused on life-prolonging interventions, but when do we learn how to approach end-of-life issues with our patients? What has your experience been as a fellow, and for those with more experience in practice, how do you navigate end-of-life issues?
What would you say to this patient and her family?
February 18th, 2013
Selections from Richard Lehman’s Literature Review: February 18th
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
JAMA 13 Feb 2013 Vol 309
Relationship Between Hospital Readmission and Mortality Rates for Patients Hospitalized With Acute MI, HF, or Pneumonia (pg. 587): Speaking of hypothesis generation, here’s a little brain teaser: if you look at risk-adjusted hospital figures for death and readmission for the commonest medical conditions – myocardial infarction, heart failure and pneumonia – would you expect to find a correlation between the two? And which way would it go? Would hospitals where more patients die have fewer readmissions? Or would they have more, because they are so bad at managing acute illness?
Well, don’t spend too long over this, because this immense study of outcomes in over 4,500 American hospitals shows that there is no correlation between risk-standardised mortality and risk-standardised readmission in these conditions, with the possible exception of some grades of heart failure. You may recollect the BMJ editorial a couple of weeks ago from the chief investigator of this study, Harlan Krumholz: nothing is straightforward when trying to assess the quality of hospitals, even using such apparently robust data. A timely lesson, as the NHS goes tipping the barrel in search of rotten apples.
Lancet 16 Feb 2013 Vol 381
Effects of Body Size and Hypertension Treatments on CV Event Rates (pg. 537): Most doctors are very uncomfortable with the fact that people over 65 who are overweight or obese live longer than those who are of “normal” weight. Not only does this run counter to the deep puritanism of medical culture, but it also flies in the face of logic, because such people are much more likely to have diabetes, heart failure and hypertension.
And yet obese people with hypertension have the best outcomes, in trial after trial. And if you give them thiazide diuretics and so increase their insulin resistance, they do even better. And if they get heart failure, they will greatly outlive their thinner peers. Here is an analysis of the ACCOMPLISH trial – don’t even try to remember which one that was – which clearly shows that thiazide treatment gives better outcomes in hypertensive fat people.
By all that’s holy in mechanistic reasoning, this should not be true, and it is all too much for the authors of the accompanying editorial. They list their objections and state:” Therefore, we reject the conclusion of Weber and colleagues that diuretic-based regimens are a reasonable choice in obese patients. On the contrary, we surmise that thiazide diuretics are contraindicated in obesity, relatively speaking.” So surmise trumps evidence? I don’t think so.
BMJ 16 Feb 2013 Vol 346
Long-Term Calcium Intake and Rates of All-Cause and CV Mortality: Less is more applies to calcium intake in older women. Many osteoporosis-fixated “women’s health experts” have recommended high calcium intake for decades, well in excess of anything that is plausibly available from dietary sources. But this mammography cohort study from Sweden followed up 39,000 women for 19 years and found that high calcium intake – over 1400mg daily as judged purely from two dietary assessments – is associated with a 40% increase in all-cause mortality and a doubling of death from ischaemic heart disease. “Harmless” chalk as sold by thousands of health supplement vendors should hereafter carry a health warning.
February 18th, 2013
St. Jude Raises the Stakes in Renal Denervation with an Outcomes Study
Larry Husten, PHD
The already hot field of renal denervation for resistant hypertension just got a little hotter. With the announcement of a clinical trial powered to detect improvements in cardiovascular outcomes, St. Jude Medical has raised the stakes in the field and demonstrated a new level of commitment to the innovative new technology.
For the past few years interest in the new procedure — which uses a catheter to deliver radiofrequency energy to disrupt renal nerves in order to produce large drops in blood pressure — has been mounting in the cardiovascular community. Results from trials with Medtronic’s Symplicity system, the leader in the field, suggest that the procedure can safely cause significant and lasting drops in blood pressure in patients with hypertension resistant to traditional drug therapy. But the Medtronic trials were not designed to measure changes in cardiovascular outcomes. Although many experts believed the Symplicity device will gain FDA approval based on these blood pressure outcomes, the reliance on a surrogate endpoint instead of important clinical outcomes leaves the technology vulnerable to criticism.
St. Jude’s announcement today appears to address concerns about the limitations of surrogate endpoints. The EnligHTNment trial, using the company’s EnligHTN Renal Denervation System, “will evaluate whether patients with hypertension that are treated with renal denervation and medication experience additional benefits beyond a reduction in blood pressure,” according to the company. It will be “the first large-scale study that will examine the long-term effects of renal denervation in patients who have uncontrolled hypertension to see if renal denervation also reduces the risk of major cardiovascular events such as heart attack, stroke and death.” EnligHTNment will be an international, multi-center, randomized, controlled study, the company said.
“To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in patients with uncontrolled or resistant hypertension,” said Michael Böhm, a principal investigator for the trial, in a St. Jude press release. “What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose blood pressure is not well controlled.”
“Initial study results have demonstrated that the EnligHTN Renal Denervation System is safe and effective in rapidly lowering blood pressure. If these results extend into the prevention of major cardiac events, there is the potential to dramatically change how we treat these patients,” said Thomas Lüscher, also a principal investigator for the trial, in the press release.
St. Jude did not announce any details of the trial, though it is expected to take 5 years to complete. The trial appears likely to demonstrate the company’s confidence in the technology and, if successful, may help quiet skeptics and improve the reception of the device in the medical community.
will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood pressurewill evaluate whether patients with hypertension that are treated with renal denervation and medication experience additional benefits beyond a reduction in blood pressure
February 15th, 2013
Amid Rising Tide of Diabetes More Patients Reach Treatment Goals
Larry Husten, PHD
There’s a glimmer of good news amidst all the recent bad news about diabetes. Although the prevalence of diabetes has doubled over the last generation, more people today are reaching their treatment goals than in the past. New data from the National Health and Nutrition Examination Surveys (NHANES), published online today in Diabetes Care, show that efforts to control hemoglobin A1C, blood pressure, and LDL cholesterol in patients diagnosed with diabetes have achieved some success, but they also demonstrate that there’s enormous room for improvement.
“The most impressive finding was the significant improvement in diabetes management over time across all groups,” said the study’s senior author, Catherine Cowie, director of the Diabetes Epidemiology Program at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in an NIH press release. “However, we see a lot of room for improvement, for everyone, but particularly for younger people and some minority groups.”
The researchers compared data on the ABCs — A1C, blood pressure, and LDL cholesterol — from 1988-1994 and 2007-2010 and found significant improvements in the rate of control for all three parameters:
- A1C control (<7%) increased from 43.1% to 52.5%.
- Blood pressure control (<130/80 mmHg) increased from 33.2% to 51.1%.
- LDL cholesterol control (<100 mg/dL) increased from 9.9% to 51.4%.
Despite the improved trend, 81.2% of patients failed to achieve all three goals.
The authors attributed the large gains to advances resulting from the important benefits achieved in key pivotal trials in glycemic control and hypertension and lipid management. The particularly large improvement in control of LDL cholesterol was likely caused by the availability and increased use of statins.
The researchers said it was “noteworthy that we found younger people with diabetes were less likely to meet A1C and LDL goals and showed smaller improvements in meeting each ABC goal.” They concluded:
As the U.S. population ages and diabetes prevalence increases, it becomes increasingly urgent to find ways to overcome barriers to good diabetes management and deliver affordable, quality care so those with diabetes can live a longer and healthier life without serious diabetes complications.
February 15th, 2013
When Patients Can Obtain Their Own EKG
Shengshou Hu, M.D.
CardioExchange welcomes this guest post from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at the University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes.
With the anno
uncement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:
Dear Dr. Fisher,
Thank you for your interest in the AliveCor Heart Monitor. I’m writing in response to your tweet to Dr. Dave (Alpert) yesterday. Below are the instructions; in addition these instructions can be found at www.alivecor.com (click on the “Buy Now” link in the upper right corner).
To obtain a monitor for your patients, please follow these steps:
1. Write a prescription for the “AliveCor Heart Monitor for iPhone 4/4S”
2. Ask your patient to go to here and submit the following:
a. The prescriber’s information – your name, address, phone number, license number and license state or NPI (National Provider Identifier)
b. A copy of the prescription (attach a scanned copy or photo)
3. Go to www.alivecor.com and click on the “Buy Now” link in the upper right to purchase the monitor
a. In the “NPI/State Medical Lic #” enter “Prescription”
NOTE: The patient’s credit card will be charged once they place their order, however we can’t process their order unless we have received their prescription.
Please know that at this time AliveCor does not provide any ECG interpretation, diagnosis or analysis of the data obtained with the monitor. Patients will be instructed to contact you, their physician, regarding any questions they may have regarding their recordings.
Please let me know if you have any questions.
Regards,
It is clear AliveCor wants to provide the device and its app, but will not be responsible for the interpretation of EKGs. That is up to the doctor and their patient how to manage the clinical expectations of this technology. While some patients could probably perform EKG interpretation basics, I would guess most don’t really understand what that wavy line means. Hence, this is where a discussion should be held with a patient BEFORE prescribing this device and the expectations defined before its use.
For me, I am happy to provide interpretations free of charge when needed as long as it is convenient and non-disruptive to my clinical responsibilities and personal life. There are only so many hours of the day and since I must value that time, cannot bill for this EKG-reading service, and have no quality control over the caliber of the recordings submitted, I consider my interpretations of tracings sent to me to be provided to the patient as a “good Samaritan” in every legal sense of the term. Patients who have clinically worrisome symptoms and need emergent analysis of their heart rhythm should seek help in an emergency department or call 911 and not expect a doctor to provide an immediate interpretation of their tracing, unless such an arrangement is defined clearly between doctor and patient before issuing the device. Expecting a doctor to make urgent clinical decisions based on this single-lead EKG app is of limited utility, in many (and maybe most) instances in my view, so patients should look at this device as a convenient adjunct to more conventional medical care. While it might come one day, the AliveCor iPhone EKG has simply has never been tested for emergency use as of the time of this writing.
So I may do a test run to see how it goes on a test basis, but I can already see some legal concerns for doctors who prescribe this device. Until a clear interpretation workflow is established that can provide comprehensive coverage of interpretations paired with a well-defined and easy-to-use interface with a medical record system, patients should understand doctors’ possible hesitation to prescribing this device to a multitude of patients for personal use.
February 14th, 2013
No Aspirin After DES? Is This The Wild, Wild WOEST?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Some patients referred for coronary stenting have atrial fibrillation or a mechanical valve, for which they are receiving chronic anticoagulation. Typically, dual antiplatelet therapy (with aspirin and clopidogrel) is prescribed to prevent stent thrombosis, but the combination of chronic anticoagulation and dual antiplatelet therapy is associated with a high risk (4–16% annually) for fatal and nonfatal bleeding. We’re “shooting from the hip,” since we don’t really know the optimal treatment after coronary stenting in these patients.
To address this issue, the WOEST (What is the Optimal antiplatElet and anticoagulation therapy in patients with oral anticoagulation and coronary StenTing) investigators randomly assigned 573 adults receiving anticoagulation and undergoing PCI to (a) clopidogrel alone (double therapy) or (b) clopidogrel plus aspirin (triple therapy); one third of the study population received bare-metal stents, and two thirds received drug-eluting stents. After 1 year of follow-up, the investigators found that double therapy (clopidogrel without aspirin) was associated with a dramatic reduction in bleeding complications and no increase in the rate of thrombotic events when compared with triple therapy.
|
Double therapy (n=297) |
Triple Therapy (n=284) |
P value |
|
| Any bleeding |
19.4% |
44.4% |
<0.001 |
| TIMI bleeding |
|
|
|
| – major |
3.2% |
5.6% |
0.159 |
| – major and minor |
14.0% |
31.3% |
<0.0001 |
| Transfusions |
3.9% |
9.5% |
0.011 |
| Stent Thrombosis |
1.4% |
3.2% |
0.165 |
In short, the results of the WOEST trial show that aspirin is not needed after coronary stenting in chronically anticoagulated patients treated with clopidogrel.
Although the trial was underpowered to detect a difference in the occurrence of stent thrombosis, no suggestion of increased thrombosis in the patients treated with only double therapy was noted.
What antiplatelet therapy do you prescribe in subjects undergoing coronary stenting who are receiving chronic anticoagulation?
Based on the results of the WOEST trial, are you willing to prescribe clopidogrel alone to these patients?
(Although just published, the WOEST trial results were previously reported by Larry Husten after they were presented at the European Society of Cardiology)
February 13th, 2013
FDA Approves Second-Generation MRI-Friendly Pacemaker System from Medtronic
Larry Husten, PHD
Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next-generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads.
Medtronic said that more than 100,000 of its first-generation Revo SureScan devices have been sold worldwide and that more than 10% of patients who have received the device have had an MRI.
When first proposed, the prospect of MRI-friendly pacemakers was greeted with considerable interest and enthusiasm. Since then, however, the devices have not lived up to initial expectations, in part because of the lack of evidence showing any danger with previous devices. According to electrophysiologist Wes Fisher, however, CMS will not pay for an MRI for patients with devices that have not been tested and approved for use with MRI. (Click here for the CMS decision memo.)
According to Medtronic, the Advisa system contains several significant new features, including these:
- a complete capture-management system, leading to improved battery life,
- higher upper tracking rates, which will allow quicker heart rates for people exercising, and
- rate-drop response to reduce syncope.
The two Medtronic devices are the only FDA-approved MRI-friendly pacemaker systems in the U.S. According to Fierce Medical Devices, St. Jude Medical and Biotronik are developing MRI-friendly pacemakers for the U.S. market.
February 13th, 2013
High Calcium Intake Linked to Increased CV and Mortality Risks in Women
Christine Sadlowski, MS
Calcium intake above 1400 mg a day was associated with increased risks for cardiovascular disease and mortality among women in a prospective Swedish study in BMJ.
More than 60,000 women aged 39 to 73 at baseline completed a diet questionnaire starting in 1987. Over a median follow-up of 19 years, women who consumed 1400 mg or more of calcium daily (through diet or supplements) had 40% higher mortality, 51% higher cardiovascular mortality, and nearly double the ischemic heart disease mortality, compared with those who consumed 600 to 999 mg. Among women with 1400 mg daily intake, those who took calcium supplements had even higher all-cause mortality (adjusted hazard ratio, 2.57).
The authors conclude that efforts to prevent bone fractures in elders should focus “on people with a low intake of calcium rather than increasing the intake of those already consuming satisfactory amounts.”
BMJ article (Free)
February 12th, 2013
ACC and STS Break New Ground to Test TAVR for Unapproved Uses
Larry Husten, PHD
In a startling break with tradition, the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.
The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the U.S. At the request of the FDA, the TVT registry was developed, according to STS former president Michael Mack, in response to “the total dissatisfaction felt by all stakeholders” over the problems engendered by a dysfunctional postmarket surveillance system. The TVT registry was then started so that U.S. physicians and hospitals could comply with Medicare’s National Coverage Decision (NCD) for TAVR. The NCD itself was originally proposed by the ACC and STS in response to concerns over the potential problems and confusion that a disruptive new technology like TAVR could unleash. The NCD ensures Medicare reimbursement for FDA-approved uses of TAVR.
But the NCD also contained a specific provision that prevented reimbursement for off-label uses unless patients were enrolled in clinical trials. At the time, none of the organizations — Edwards Lifesciences (manufacturer of the Sapien device), FDA, CMS, ACC, and STS — imagined that the ACC and STS would end up seeking an IDE as a result of this provision. Said Mack: “this was an unintended consequence of the way the NCD came out. We weren’t smart enough to anticipate this, that by applying for the NCD, we were getting into the IDE business.”
Ralph Brindis, a former president of the ACC, explained that as physicians became familiar with TAVR they grew interested in exploring off-label uses of the device. The new trials will mean that reimbursement will now be possible for some of these uses when patients are enrolled in the clinical trials. According to Mack, the NCD “took off-label use off the table. If you are a cynic this is good, but if you’re a practitioner this is tying your hands.”
“This is the first time the societies have ever filed for an investigational device exemption,” said Brindis. “The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.”
The first trial will study alternatives to transfemoral approaches in 1,000 patients considered ineligible for aortic valve surgery. “Since transapical and transaortic [approaches] were not studied in the inoperable patient population, they aren’t covered,” Michael Mack told The Gray Sheet. “The only way to get them covered is by getting an FDA label. How do you get an FDA label — you have to get approval by an investigational device exemption study.”
Brindis and Mack said that the ACC and STS worked closely with CMS, the FDA, and Edwards Lifesciences to develop the trial protocol. In the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical and transaortic approaches and will be compared with the results of patients in the original PARTNER A trial who received TAVR through the transapical approach. Mack concedes that the trial design is not ideal. “There is no perfect comparator,” he acknowledged.
Other experts in the field contacted by CardioExchange agreed that the challenges of trial design in this situation are quite formidable. Randomized trials are not always feasible and, in some situations, may be unethical. The IDE is an attempt to balance the need for rational clinical trials, on the one hand, and the growing pressure to perform off-label procedures. It should be noted that an important safeguard for patients remains in place: all potential TAVR patients will still need to be evaluated by both a cardiologist and a cardiac surgeon as part of the “heart team” approach mandated by the FDA and the NCD. (See my previous post, Politics and Transcatheter Aortic Valve Replacement, for more background and discussion about the introduction of TAVR in the U.S.)
The ACC and STS are now working to gain FDA approval to perform two more studies. One would examine the role of alternative approaches in the high-risk population eligible for surgery. The second would study valve-in-valve TAVR procedures. Both studies also present challenging problems of trial design. Mack said he anticipates FDA approval of these protocols in the next few months.
Edwards Lifesciences has played a quiet role in these proceedings so far. According to Brindis and Mack, Edwards has helped support the ACC and STS effort. Now that supporting role is scheduled to grow: on Monday, Brindis said, Edwards agreed in principle to fund the clinical trials. An Edwards representative confirmed that the company planned to support these new trials, but the details have not yet been hammered out.
February 12th, 2013
Conflict Of Interest Is A Complex Issue
Robert McKinnon Califf, MD and Harlan M. Krumholz, MD, SM
In a recent editorial in the Journal of the American College of Cardiology, Robert Califf discusses a few of the many complex questions related to the conflict of interest issue. Here CardioExchange’s Harlan Krumholz further explores the issue with Califf.
CardioExchange: Do you think that conflict of interest issues are mostly an issue about optics and not substance – or are you concerned that relationships with funders sometimes influence the science in ways that are not favorable to society?
Califf: I believe that financial conflict of interest has real substance, but that focusing exclusively on the medical products industry and failing to consider other sources of conflict of interest is a huge mistake and leads to sensationalism that then engenders reactive rules that add to bureaucracy rather than addressing the real issues. Yes, relationships with funders (medical products industry, NIH, foundations) have a huge influence on science as do professional rivalries, egos and desire to appear in the press (fame).
CardioExchange: One concern is that many trials are not under the control of the principal investigator– do you think that the profession should insist on trials that are not under the control of the funder?
Califf: I do not believe that a human experiment should be “under the control” of any single individual. Every aspect of a clinical trial is a compromise and no one gets everything they want. In fact a despotic, egotistical principal investigator can be just as dangerous as a controlling funding organization. Like our constitution, trials need a balance of power: PI, executive committee, steering committee, investigators, DMC, regulators, funders—all have a role to play. Yes, the PI ultimately is responsible, just as Hillary Clinton and Barack Obama were responsible for the security of our embassies—but there are many players. People understand this, and we should think of trials the same way. Indeed, one of the biggest influences on trials will now be the participants themselves,who are rightly becoming invovled in design, conduct and interpretation of trials.
CardioExchange: Even when the trial is not under the control of the funder, there may be other types of control. Should the PI and investigators always have full control of the data?
Califf: For now, I believe the sponsor and the trialists should both have the data under a set of rules agreed to before the trial starts. The biggest issue here is that most academic institutions are incapable of correctly managing complex trial data or analyzing it, so the PI’s are dependent on analyses from the sponsor or a CRO (clinical research organization) hired by the sponsor. I DO BELIEVE THAT INVESTIGATORS SHOULD ANALYZE THE DATA INDEPENDENTLY WITH ACCESS TO THE FULL DATA SET.
CardioExchange: What is the best path forward with conflict of interest, assuming that disclosure is not enough (since it is hard to interpret)?
Califf: The best path forward is transparency and public access to the data so that many people can analyze and interpret. This will take time. Importantly, my interpretation of the available information is that:
- Academic analyses have more major errors and are not as reproducible as industry analyses. The oversight and punishment of bad behavior by FDA is important.
- Bias in choosing the question is a much bigger issue than lying about the data.
- In industry-sponsored trials, lying about the data is rare. Lying by omission (not looking at aspects of the data) is much more common.
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