Like many other bloggers and journalists I get a lot of unsolicited and unwanted pitches. For years I just threw them in the trash. Now I’m going to share some of these gems with the rest of you. Here’s the first installment (click to enlarge):
Like a certain late lamented parrot, CardioExchange is no more. It has ceased to be.
The website was started by the New England Journal of Medicine and the Massachusetts Medical Society more than 5 years ago in the wake of the explosive and ubiquitous growth of social media. But the rise of social media also provoked tremendous uncertainty and even anxiety over its role in healthcare and medicine. In response to this major transformation of the media landscape, MMS and NEJM launched CardioExchange as an experiment in social media for cardiologists and other healthcare professionals interested in cardiovascular medicine.
Let’s start with a quick poll:
Which is worse?
- A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians.
- B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights.
If you chose B then you are going to really love Lisa Rosenbaum’s 3-part series in the New England Journal of Medicine in which she argues that the reaction against the influence of industry has proved to be far worse than any damages those conflicts of interest (COI) have actually produced.
I think Rosenbaum is almost completely mistaken in her views…
How does a clinical laboratory company grow in a few short years from nothing to more than $400 million in revenue and over $100 million in profit? Since the same company just settled with the DOJ for as much as $100 million, it’s reasonable to suspect that growth was probably not entirely legitimate.
Now new information, gleaned from documents containing previously unreported details about the company, provides an inside look at the inner workings of the company and its rampant growth, fueled by greed and a massive disregard for law and industry standards. Except where otherwise indicated, the details of HDL’s finances reported below come from a financial statement and a spreadsheet prepared by the company and made available to me by a source. The details are consistent with information revealed by a former company employee with intimate knowledge of HDL’s finances.
Previous Stories About HDL:
- Beyond Kickbacks: More Questions About Unnecessary Cardiovascular Biomarker Tests
- Way Beyond Kickbacks: More Serious Misconduct Alleged Against Medical Testing Company HDL
- Embattled HDL Laboratory CEO Resigns Amid Federal Investigation
- Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack!
- Cigna Sues Embattled HDL Laboratory For $84 Million
- Embattled Lab Nears Settlement With Government Over Kickbacks
- DOJ Settles With Embattled Lab, Criminal Charges For Executives Still Possible
The increased risk of stroke in people with atrial fibrillation (AF) is well known, and this stroke risk is, of course, linked to an increased risk of cognitive impairment and dementia. Less well known is that people with AF have an increased risk for cognitive impairment independent of their stroke risk. Now a new study published in Annals of Internal Medicine offers evidence that this increased risk may be linked to a higher rate of silent strokes in AF patients.
A new study published in JAMA suggests that younger patients who need aortic valve replacement (AVR) may now be more eligible to receive bioprosthetic valves. Each year about 50,000 people in the U.S. undergo AVR surgery. Older patients generally receive bioprosthetic valves because these valves are less prone to clotting and bleeding complications. Surgeons are often reluctant to use bioprosthetic devices in younger patients because these devices are more likely to deteriorate and require a repeat operation.
Researchers at Mt. Sinai Medical Center analyzed data from 4253 patients in New York State who were 50-69 years of age and who received a bioprosthetic or mechanical valve.
The problems go way beyond kickbacks. As previously reported (here and in the Wall Street Journal) the US government is conducting an investigation into Health Diagnostic Laboratory, a medical laboratory testing company that has enjoyed explosive growth since its founding in 2008. Previous reports centered on kickbacks given to physicians by the company to encourage greater use of the company’s tests. The new allegations suggest a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.
The main new accusation involves HDL’s sales force, who work for an independent but closely related company known as BlueWave Healthcare Consultants Inc. These salesmen persuade physicians and other healthcare providers to order a whole host of unnecessary tests from HDL and, often, from other lab companies as well, including Singulex and Innovative Diagnostic Laboratory (IDL). As the WSJ article explained, kickbacks to physicians occur when the companies give excessive process and handling (P&H) fees instead of the $3 “draw” fee generally allowed by Medicare. My sources inform me that by combining multiple tests from multiple companies these fees can climb to as much as $100 per patient. This is called “stacking.”
To prevent patients and insurers from looking too closely at these practices the company has a policy of rarely if ever requesting co-payments from patients. Therefore the physicians profited from the kickbacks and the company benefited by collecting the portion of the charges which escape scrutiny from insurance companies and Medicare. Both the promotion of unnecessary tests and the refusal to collect co-payments are illegal and unethical, say experts.
The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for more than a decade and has attracted considerable doses of support as well as skepticism.
An all-star group of cardiology leaders– including Sir Nicholas Wald, Salim Yusuf, Suzanne Oparil, Sidney Smith, and Clyde Yancy– helped provide the spoonful of sugar that helped the committee swallow the polypill. The FDA also eased the way by limiting the discussion to the use of the polypill for secondary prevention in people who have already had a MI or a stroke.
It seems like a no brainer. Cardiovascular disease is the #1 killer in the world so broad screening of the general population must be a good idea, right? Wrong, says the consumer group Public Citizen, at least when such screening is performed indiscriminately. Somewhat surprisingly, Public Citizen, which is often held at arm’s length by mainstream medicine, gained some support for its position from a major cardiology organization.
In its statement Public Citizen urged 20 hospitals to sever their involvement in a mobile cardiovascular screening program. The HealthFair Cardiovascular Screening Packages are unethical, mislead consumers, and do more harm than good, said Public Citizen.
In a blog post, the president of the American College of Cardiology. Patrick O’Gara, said that “the questions raised about screening have some merit…. we do not recommend broad and untargeted screening.”
The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation.
A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, there was a significant, 47% reduction in mortality with thrombolysis relative to standard anticoagulation, but this was accompanied by significant increases in major bleeding, including intracranial hemorrhage.
What role should Coca-Cola and other food and beverage companies play in funding and communicating research about nutrition and obesity?
The question is prompted by a recent article in the Journal of the American College of Cardiology. The “state-of-the-art” paper reviews the relationship of obesity and cardiovascular disease and presents the case that a decline in physical activity is the primary cause of the obesity epidemic. The article downplays the role of calories and diet and does not include the words “sugar,” “soda,” or “beverage.” Three of the five authors of the paper report financial relationships with Coca Cola.
The avalanche of data released by Medicare on Wednesday was followed shortly by an avalanche of news reports about the data. Here’s a review of some of the more significant cardiology-related details that came out in these stories.
Cardiology was the third in a New York Times list of total Medicare payments received by the highest-paid 2% of doctors. This 2% accounted for nearly one-fourth of total Medicare payments. There were 2,176 cardiologists in the top 2% group and they received more than 1.6 billion dollars from Medicare. Ahead of cardiologists at the top of the list were ophthalmologists (2,995 providers who received more than $3.3 billion) and hematologists/oncologists (1,831 providers who received more than $2 billion).
The Washington Post‘s Wonkblog asked the top 10 Medicare billers to explain their charges…
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization.
PARADIGM-HF randomized patients with heart failure and reduced left ventricular ejection fraction to either the ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class.
There’s been a lot of speculation that future Apple products will include health-related apps and biometric sensors. Here’s the story of what might have been the first Apple medical app, except for the fact that in 1977 Steve Jobs had absolutely no interest in going in that direction.
George Diamond is now retired after a long and very distinguished career as a cardiologist at Cedars-Sinai Medical Center in Los Angeles. But in 1977 he was just starting his career at Cedars, where he was working on cutting-edge devices and statistical methods to improve the diagnosis of heart disease (a major problem that even today is far from being solved).
So I picked up the telephone and called Apple in Cupertino. I told the secretary that I wanted to speak with somebody about a medical application for the Apple II computer. The secretary connected me directly to Steve Jobs. (Of course I didn’t know who he was. I didn’t even recognize the name as being one of the people who had actually invented the thing.)
Once again the U.S. Preventive Services Task Force (USPSTF) has concluded that there is no good evidence to support the routine use of multivitamins or most individual or combination vitamins by healthy adults to prevent cardiovascular disease or cancer.
The USPSTF also recommended against the use of two specific vitamins — beta-carotene and vitamin E. Beta-carotene has been linked to a significant increase in the risk for lung cancer among smokers, while “a large and consistent body of evidence has demonstrated that vitamin E supplementation has no effect on cardiovascular disease, cancer, or all-cause mortality.”
For other vitamins or multivitamins, the task force found few significant harms, though they said the evidence was insufficient to allow definitive assessments of the risks and benefits.
Cardiologist Victor Dzau will leave his positions as the chancellor for health affairs at Duke University and the CEO of the Duke University Health System to become the next president of the Institute of Medicine. He will replace Harvey Fineberg, who has been the IOM president for the last 12 years.
“I am humbled and honored to be selected to lead the IOM at a time of unprecedented opportunities and challenges in health, health care, and biomedical sciences,” said Dzau in a statement from the IOM. “Harvey Fineberg has been an exceptional leader of the IOM, and I am committed to building on his outstanding work and advancing the impact of the IOM on the nation and globally.”
Before moving to Duke almost a decade ago Dzau was the chair of the department of medicine and director of research at Brigham and Women’s Hospital and the Hersey Professor of the Theory and Practice of Physic (Medicine) at Harvard Medical School. Prior to that he had been the chair of the department of medicine at Stanford University. In his career as a researcher Dzau played a key role in understanding the renin-angiotensin-aldosterone system.
Robert Califf, director of the Duke Translational Medicine Institute, sent the following comment:
This appointment is a real honor for Victor and for Duke. During his tenure, the instituiton has grown into an academic health and science system, made numerous scientific contributions and thrived financially.
Dzau was first elected to the IOM in 1998. He will begin his six-year term as president on July 1.
The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the vote was 13-1.
Nut consumption has long been linked to healthy lifestyles. Now, a study in the New England Journal of Medicine extends the finding and demonstrates a strong association with improved mortality.
Ying Bao and colleagues examined data from nearly 120,000 people enrolled in the Nurses’ Health Study and the Health Professionals Follow-up Study to assess the relationship of nut consumption and mortality. With over 3 million person-years of follow-up, the investigators found a strong inverse correlation between the frequency of nut consumption and mortality, after adjusting for other risk factors.
Here are the hazards ratio for death based on frequency of nut consumption (compared to no consumption):
Surgery is thought to be life-saving for people who have ischemic mitral regurgitation, but it is unknown whether surgical repair or surgical replacement of the mitral valve is the better procedure. Repair is thought to result in fewer preoperative deaths and replacement is thought to have better long-term outcomes with a reduced incidence of recurrent mitral regurgitation. In recent years, many surgeons have grown to favor repair. Currently about two-thirds of patients in the US undergo a repair operation.
In a trial presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine, members of the Cardiothoracic Surgical Trials Network randomized 251 patients with severe ischemic mitral regurgitation to either repair or replacement.
At one year there was no difference in the primary end point, left ventricular end-systolic volume index, between the two groups.
When the AHA and the ACC released four updated clinical guidelines earlier this week, a fifth document, the hypertension guideline, was conspicuous by its absence. According to the AHA and the ACC, the authors of the hypertension document have chosen to publish it independently. (No word has yet emerged about their reasons for doing so or when the document will be published.) In response, the AHA and the ACC announced that they would publish full hypertension guidelines in 2014, but in the meantime would publish a brief interim document. Now the two organizations, in conjunction with the Centers for Disease Control, have published a scientific advisory on the AHA and the ACC websites.
Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi), Amgen, and Pfizer might suffer significant delays.
The guidelines delivered a strong statement questioning the increasingly controversial theory that LDL lowering by itself is beneficial. “We found that non-statin therapies really didn’t provide an acceptable risk reduction benefit compared to their potential for adverse effects in the routine prevention of heart attack and stroke,” said the co-chair of the guideline. This led many observers to think that the FDA would likely require the developers of PCSK9 inhibitors to complete cardiovascular outcome trials before getting US approval. This decision would delay approval for several years.
Then, on Thursday, the companies developing PCSK9 inhibitors received some apparent good news. Bloomberg News reported that an FDA official said that the drugs “will only have to meet the U.S. Food and Drug Administration’s existing standards for clearance, including whether they cut cholesterol and reduce blood pressure or inflammation.”
But then the FDA added one other very important caveat. Here’s how they phrased it to me:
The FDA said today that it would begin to take efforts to remove trans fats from food in the USA. The agency has made the “preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not ‘generally recognized as safe’ for use in food.”
If the FDA’s preliminary determination is made final then manufacturers will be required to reformulate products containing PHOs. FDA will seek comments on the proposal for 60 days “to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat.”
New results from a long-running study offer fresh evidence that a “healthy” diet is actually good for you. The study shows that women who followed a healthy diet while in middle age had a much better chance of reaching 70 without any of the major illnesses or impairments usually associated with old age.
In a paper published in the Annals of Internal Medicine, Cecilia Samieri and colleagues analyzed data from 10,670 women who participated in the Nurses’ Health Study and who had no major diseases in the mid-1980s when they were in their late 60s and early 70s. They found that women with healthy diets (as assessed by the Alternative Healthy Eating Index-2010 and the Alternate Mediterranean diet scores) were much more likely to reach the age of 70 with no major chronic diseases, no impairment in cognition, no physical disabilities, and intact mental health.
Instead of investing in pharma maybe you should go to Vegas instead. You’ll have a lot more fun and, a new study suggests, your chances of winning are just as good.
The key to understanding the pharmaceutical industry is predicting sales of individual drugs. But, in a study published in Nature Reviews, 3 consultants at McKinsey & Company determined that drug companies, and the sell-side analysts that watch them, have a really poor record when it comes to predicting future sales of drugs, not just unapproved drugs not yet on the market but also even approved drugs with existing sales.
Myoung Cha, Bassel Rifai, and Pasha Sarraf first assessed the accuracy of 1700 analyst’s estimates for 260 drugs launched between 2002 and 2011. Their findings were striking:
New allegations about scientific misconduct have been raised about a cardiology group in a hospital in Italy. Some of the allegations come from a surprising source: Maria Grazia Modena, the former and highly prominent chief of cardiology at the hospital where the research was said to have been performed.
The new allegations are the latest episode in an ongoing saga that began last year involving many of the same researchers, including Maria Grazia Modena herself. As I first reported last November, nine Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The charges included conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. The most prominent person arrested was Maria Grazia Modena, who is also a former president of the Italian Society of Cardiology. (The fact that she shares her last name with the city and the hospital where she works appears to be a coincidence.)
The suspicion that there might be problems with the paper first emerged when Maria Grazia Modena, who was originally listed as a co-author, publicly distanced herself from the paper and said that she was not an author of the paper and had had nothing to do with the study. To date the only public acknowledgement that there might be problems with the paper is an erratum published in AJC stating that Modena “was not associated with this manuscript” and that “the authors apologize for this error.”
I personally asked the physicians and fellows who were working in the department (except the authors of the manuscript) if anyone have ever heard about the study. Nobody had ever seen informed consents or appointments for study-related peripheral echo in 8 years.
In the methods section of their manuscript, the authors stated that echo examinations were made with [a GE Healthcare transducer]… That echocardiography machine was bought around 2005-2006 (the authors report they started the study in 2002).