Embattled Lab Nears Settlement With Government Over Kickbacks Reply

Health Diagnostic Laboratory Inc, the embattled lab company, is nearing a $50 million settlement with the Justice Department, according to a Wall Street Journal story by  John CarreyrouAs previously reported here, the federal government is investigating HDL for giving kickbacks to physicians  who use  the company’s tests. Additional allegations suggest a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs? Reply

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs may lead to significant reductions in heart attacks, stroke, and other cardiovascular events. But one finding, though not entirely new, has prompted a lot of discussion and concern.

Both studies reported a small but significant number of adverse neurocognitive effects in people taking the drugs. No one knows yet how important this finding will be, but it is clear that concerns about a real effect might have its own “adverse effect” on the drugs’ approval process.  Most experts seem to feel that they won’t be a very big problem, but none completely dismissed the issue either. Here are some of the main points under discussion:

Click here to read the full post on Forbes

 

 

 

What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific Reply

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions.

Click here to read the full post on Forbes.

 

High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic Reply

Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. Because of early concerns about potential overuse and misuse of TAVR, many observers have been eagerly awaiting information about its use in the real world.

Now a new report published in JAMA offers the best perspective yet on the introduction of TAVR in the US with an analysis of  the one year outcomes of the first group of patients who underwent the procedure.

Click here to read the full post, with comments from Sanjay Kaul and Ajay Kirtane.

Orexigen ‘Crying All The Way To The Bank’ After ‘Egregiously Unethical’ Actions Reply

On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to them and a very few other people within the company and the FDA– had been revealed to the world by Orexigen. When the news sank in the meeting broke into a scene of high drama and emotion. “I’ve never seen anything like this in 20 years,” said one participant. At one point, I’ve been told, the DMC members were reading my initial story about the data release on a monitor in the meeting room.

The disclosure of the data unleashed a firestorm of criticism directed at Orexigen but also a dramatic 40% increase in the company’s stock, adding about $400 million to Orexigen’s market capitalization. But some believe that despite the short term gain ultimately there may be important negative consequences for the company and its leaders. Certainly the company hasn’t made any friends this week at the FDA or among the doctors and statisticians who perform clinical trials.

The Tuesday meeting was extraordinarily eventful, but in truth the DMC’s activities throughout the trial had never been a day at the beach.

Click here to read the full post on Forbes.

 

Takeda Disagrees With Orexigen Over Data Disclosure Reply

(Updated)

On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data.

Here is the Takeda statement:

“Pursuant to the Collaboration Agreement between Takeda and Orexigen, Orexigen has the sole right and responsibility for the drafting, prosecution and issuance of Orexigen patent filings.  Takeda respects the need to vigorously protect intellectual property relating to pharmaceutical products; however, Takeda does not support the issuance of patents that contain and disclose interim data results of an ongoing clinical trial.  Takeda is working with the academic leadership of the Light trial (Data Monitoring Committee, Executive Steering Committee) and the FDA to determine the most appropriate next steps for the LIGHT trial.”

Update:

And here is Orexigen’s mildly updated statement about the events:

Orexigen conducted a large cardiovascular outcomes trial in order to file for approval, with the study planned to continue after approval to serve a postmarketing regulatory requirement for additional risk exclusion. We observed an unexpected result in the interim analysis. We filed patent applications based on the results in order to preserve the potential for additional intellectual property. Prior to approval in September 2014, the FDA informed us it had determined that the Light Study would not serve as the postmarketing requirement for Contrave; an entirely new trial would be required. At that point, the company decided to continue with the patent prosecution. The second cardiovascular outcomes trial is expected to start later this year. We are confident that this trial can be enrolled and conducted successfully and we look forward to the results, which are expected by 2022.

On March 3 2015 the USPTO published an issued patent and supporting documentation, and we believed it was appropriate and necessary to make sure this information was equally available to all investors.
Orexigen proactively discussed the challenges inherent in using interim data from ongoing trials for regulatory approvals, and has been, and continues to be, committed to working with FDA and others to support its regulatory obligations to thoroughly explore Contrave’s therapeutic profile. Just as important, Orexigen is committed to its obligation to patients to fully explore the drug’s profile.
Orexigen is also committed to simultaneously meeting its obligations to other regulatory authorities in the U.S., such as the SEC, and abroad, such as the EMA, which are relevant to, and have authority over, its business. The Company is similarly committed to meeting its fiduciary duties to shareholders.

I will have much more to report about this story soon.

 

 

Orexigen Released Interim Data Without Approval Of Trial Leaders Reply

Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.)

The surprising thing about the Orexigen disclosure, which was contained in a Form 8-K filed with the SEC, is that it consisted of data derived from an interim analysis of the company’s ongoing Light trial. Normally, interim results are performed by an independent data monitoring committee and the results are known only to the members of the DMC. Occasionally, when important regulatory issues are at stake, the FDA may also be involved. But the detailed results of the analysis are never made public until the trial is stopped.

In this case neither the DMC nor the trial Executive Committee, headed by the Cleveland Clinic’s Steve Nissen, knew about or approved the release of the data. Here’s a statement Nissen sent me:

Click here to read the full post on Forbes.

 

No, Drinking Coffee Won’t Save Your Life Or Prevent Heart Attacks Reply

Once again the media has swallowed the bait hook, line, and sinker. Following the publication of a  a new study in the journal Heart last night, hundreds of news reports have now appeared extolling the miraculous benefits of coffee. Here’s just one typical headline from the Los Angeles Times: “Another reason to drink coffee: It’s good for your heart, study says.”

But a careful look at the study and previous research on coffee makes clear that this type of reporting is completely unwarranted….

Click here to read the full post on Forbes.

 

 

 

New York City Ebola Doctor Slams Media And Governors Christie And Cuomo Reply

The response in the US to the Ebola crisis last year brought out the worst in the media and our politicians. By comparison, our response to the recent measles crisis– by no means a model for public health communication– had the sophistication and intelligence of a debate at the Oxford Union.

One of the chief victims of the hysteria was Craig Spencer, a New York City emergency room physician who caught Ebola while volunteering in Africa. When he first developed Ebola symptoms after his return to New York City he went straight to the hospital, where he eventually recovered after a harrowing illness. No one– neither his fiancee nor any of the people he interacted with in the days and hours before developing symptoms– caught Ebola from him. Every public health expert said that his behavior was exemplary.

But, as we all know, he did not receive praise in the media, or by the governors of New York and New Jersey. Instead, along with other healthcare workers who heroically went to Africa to help fight the epidemic, he was denigrated and condemned.

Now, months later, Spencer has presented his perspective on these events in an article in the New England Journal of MedicineWe should pay attention to his words. Here are a few excerpts, but by all means click over to NEJM and read the whole thing.

I understand the fear that gripped the country after I fell ill, because I felt it on a personal level. People fear the unknown, and fear in measured doses can be therapeutic and inform rational responses, but in excess, it fosters poor decision making that can be harmful. After my diagnosis, the media and politicians could have educated the public about Ebola. Instead, they spent hours retracing my steps through New York and debating whether Ebola can be transmitted through a bowling ball. Little attention was devoted to the fact that the science of disease transmission and the experience in previous Ebola outbreaks suggested that it was nearly impossible for me to have transmitted the virus before I had a fever. The media… fabricated stories about my personal life and the threat I posed to public health, abdicating their responsibility for informing public opinion and influencing public policy.

Meanwhile, politicians, caught up in the election season, took advantage of the panic to try to appear presidential instead of supporting a sound, science-based public health response. The governors of New York and New Jersey, followed by others, enacted strict home quarantine rules without sufficiently considering the unintended side effects…. At times of threat to our public health, we need one pragmatic response, not 50 viewpoints that shift with the proximity of the next election….

Instead of being welcomed as respected humanitarians, my US colleges who have returned home from battling Ebola have been treated as pariahs….

When we look back on this epidemic, I hope we’ll recognize that fear caused our initial hesitance to respond– and caused us to respond poorly when we finally did. I know how real the fear of Ebola is, but we need to overcome it. We all lose when we allow irrational fear, fueled in part by prime-time ratings and political expediency, to supersede pragmatic public health preparedness.

 

 

Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year Reply

Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their drawing boards to redesign the devices.

Click here to read the full post on Forbes.

 

No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year Reply

In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case….

Click here to read the full post on Forbes.

 

Amgen Door Hanger

More Guideline Controversy: The Tricky Business Of Calculating Cardiovascular Risk Reply

Calculating cardiovascular risk has become a central and highly controversial component of cardiovascular guidelines. Now a study in the Annals of Internal Medicine finds that most of the commonly employed tools seriously overestimate the risk of people today.

Click here to read the full post on Forbes.

Very Simple High-Fiber Diet Stands Up To American Heart Association Diet Reply

Diets notoriously fail to help people lose a lot of weight. One problem is that most diets include a broad range of restrictions and guidelines that many people find difficult to follow. Another problem is that negative recommendations may have unintended consequences, such as low-fat recommendations leading to increased consumption of refined carbohydrates. Now a new study published in the Annals of Internal Medicine indicates that a radically simple diet containing only one positive rule — eat more fiber — might be nearly as effective and much easier to swallow than a more traditional complex diet.

Click here to read the full post on Forbes.

 

New US Guidelines Will Lift Limits On Dietary Cholesterol Reply

The influential  Dietary Guidelines Advisory Committee has recommended that limitations on dietary cholesterol be removed from the upcoming 2015 edition of Dietary Guidelines for Americans. Recommendations to reduce dietary cholesterol have been a mainstay of the USDA and other guidelines for many years, starting with guidelines from the American Heart Association in the 1960s.

Click here to read the full post on Forbes.

 

 

No, Too Much Jogging Probably Won’t Kill You 1

One again lazy health journalists have fallen down on the job and performed a disservice to the public. The new outrage: a multitude of media reports about a small study on the effect of jogging on mortality. Here are just a few headlines, published minutes after the study was published in the Journal of the American College of Cardiology:

But a careful reading of the paper shows that this small study provides nowhere near enough evidence to support these headlines.

Click here to read the full post on Forbes.

jacc_ci_021015_schnohr

FDA Approves New Heart Pump From Abiomed Reply

Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival rate was 73% at 30 days.

Click here to read the full post on Forbes.

 

 

Califf To Leave Duke To Become FDA Deputy Commissioner Reply

The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.”

Click here to read the full post on Forbes.

 

Salt, Science, And The American Heart Association’s Double Standard Reply

Once again the American Heart Association is sticking by its recommendation that pretty much everyone should consume no more than 1,500 milligrams of sodium each day. This is dramatically lower than the 3,500 mg/d the average American now consumes. In a blog post reprinted on MedPage Today the president of the American Heart Association,  Elliott Antman, assails a study published earlier this week which found no benefits– and even a hint of harm–  for elderly people with low sodium consumption.

But Antman only tells one side of the story.

Click here to read the full post on Forbes.

 

Why Doctors, Like Airline Pilots, Should Not Be Completely Trusted.  Reply

I would never get on an airplane if I didn’t feel highly confident that the pilot was fully competent. In order to fly a commercial airplane a pilot has to  undergo rigorous and continuous training and testing. I’d walk before flying with a pilot whose only credential was his assurance that he’d been diligently “keeping up with his field” and that he was extremely confident in his abilities. I’m glad to know that the FAA and the airlines have extremely demanding programs to ensure the competency of pilots.

I would trust 99% of pilots to remain competent on their own. But when it comes to flying 99%” isn’t good enough. We need to know, within the bounds of what is reasonable, that all pilots are competent. Unfortunately, because of the few bad ones, the remaining 99% have to undergo all the rigorous training and tests.

Doctors are like pilots: what they do is far too important to let them individually decide for themselves whether they are competent, or how they should demonstrate their competency. Just because the vast majority of pilots and doctors are competent doesn’t mean that we should loosen our standards.

This topic is important now because of a current red-hot debate over what physicians have to do during their career to maintain their certification– called maintenance of certification, or MOC…

Click here to read the full post on Forbes.

 

Intense Exercise Doesn’t Eliminate the Hazard of Intense Sitting Reply

James Brown had it right. There may be no better medical advice these days than to “Get Up Offa That Thing.

A large new analysis published in Annals of Internal Medicine supports earlier observations that the health hazards of sedentary behavior aren’t completely neutralized by exercise.

Researchers in Toronto scoured the literature to find studies that assessed the health effects of sedentary behavior adjusted for physical activity. They found 47 studies, including 13 that assessed all-cause mortality, 14 that assessed cardiovascular disease and diabetes, and 14 that assessed cancer. Sedentary behavior was defined as “waking behaviors characterized by little physical movement and low-energy expenditure,” including sitting and television watching.

Click here to read the full post on Forbes.

 

James Brown screenshot

 

How Much Salt Should Old People Consume? Reply

A new study offers fresh evidence that current salt recommendations should be taken with, well, a grain of salt. Current guidelines now recommend that everyone should have sodium intake levels below 2300 mg per day. For many people at higher risk, including everyone over 50 years of age, sodium intake should be below 1500 mg/d. (The American Heart Association promotes the more rigorous goal of 1500 mg/d for everyone.) But a 2013 report from the Institute of Medicine, along with findings from the PURE study published last year, have raised concerns that the lower target level in particular is neither practical nor beneficial.

The new study, published in JAMA Internal Medicine, looks at the growing and important elderly patient population…

Click here to read the full post on Forbes.

 

 

Buried Clinical Trial Data: The Dam Is About to Burst Reply

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials.

… a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial.

… the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data.

Click here to read the full post on Forbes.

 

Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease Reply

A 40-year program in one poor rural county to combat cardiovascular disease appears to have been successful, resulting in reduced rates of hospitalization and death compared with other counties in the same state over the same time period. The new findings from the study are described in a paper published in the Journal of the American Medical Association.

Click here to read the full post on Forbes.

 

More Turmoil For Troubled Medical Laboratory Company Reply

Problems continue to accumulate for the deeply troubled medical laboratory company Health Diagnostic Laboratory. Following several years of spectacular growth, in which the company grew to $400 million in annual revenue, the company last year began an equally spectacular implosion when it became known that the federal government was investigating the company for giving kickbacks to physicians to use the company’s tests. Additional allegations suggested a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

In the latest development HDL terminated its contract with BlueWave Healthcare Consultants, the sales company that played a crucial role in HDL’s explosive growth. In response BlueWave filed a lawsuit against HDL for $205 million…

Click here to read the full post on Forbes.