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:

Gilead’s Hepatitis Drugs Tripped By Old Heart Drug Reply

Late last week Gilead Sciences issued a warning about a rare but potentially fatal interaction between its stellar new hepatitis C drug sofosbuvir and amiodarone, a potent but tricky antiarrhythmic agent. Sofosbuvir is marketed as Sovaldi and, in combination with another antiviral agent, as Harvoni. Amiodarone, which is used to treat dangerous heart rhythm problems, has a number of different side effects and an extremely long half-life. Its use is generally reserved for difficult cases.

Gilead reported nine cases of symptomatic bradycardia (slow heart rate). One patient died of a cardiac arrest and 3 patients received a pacemaker.

Click here to read the full post on Forbes.

 

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.

 

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.

 

 

Everybody Into The Sauna? 1

Spending more time in the sauna may lead to a longer and healthier life– at least if you live in Finland, according to a new study published in JAMA Internal Medicine.

Finnish researchers analyzed data from the Kuopio Ischemic Heart Disease Risk Factor Study. The new analysis focused on 2,315 middle-aged men who had 1, 2-3, or 4-7 sauna bathing sessions per week. After 20 years of followup the rate of sudden cardiac death, fatal coronary heart disease, fatal cardiovascular disease, and all-cause mortality was significantly reduced in people who used the sauna more often.

Click here to read the full post on Forbes, including comments from Franz Messerli, Harlan Krumholz, and John Ryan…

 

800px-Smoke_sauna

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.

 

Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race Reply

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA) for alirocumab, their PCSK9 inhibitor…

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.

 

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.

 

AstraZeneca Drug Improves Outcomes After Heart Attacks Reply

For the first time a very large trial has shown that dual antiplatelet therapy (DAPT) improves cardiovascular outcomes when given to patients one to three years after a heart attack. Because it has been shown previously to reduce the high risk of recurrent events for up to a year following a heart attack, DAPT is considered to be standard therapy during this time period. But whether or not longer term treatment after a year would be also beneficial has been controversial.

AstraZeneca  today announced that the Pegasus-TIMI 54 study had successfully reached its primary endpoint.

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.

 

Three Reasons Why You Don’t Need To Feel Sorry For Doctors Reply

I’m not a doctor and I don’t have strong opinions about how doctors should be certified or, more to the point right now, what they should have to do to maintain their certification over the course of their careers. But recently this last topic– called maintenance of certification, or MOC– has become the subject of a raging debate within the medical community, as thousands of doctors have expressed their displeasure, to put it mildly, with a new recertification scheme established last year by the American Board of Internal Medicine, the official “certifying” body of a large proportion of doctors in the US. From what I’ve read it appears that the critics of the new system have some very legitimate points and that some big changes will likely be necessary. But in the course of the debate I have been disturbed by some of the arguments that have been used to criticize the new MOC. (Unfortunately I haven’t seen a lot of attempts to actually defend the new scheme so I can’t give equal time to the other viewpoint.)

Click here to read the full post on Forbes.

 

FDA Approves New Oral Anticoagulant From Daiichi Sankyo 1

And then there were four.

Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace…

Click here to read the full post on Forbes, including a comment from Sanjay Kaul.

 

An Emerging Consensus About Novartis’s New Potential Blockbuster Reply

Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in cardiovascular mortality, electrified the cardiovascular community. But the trial also sparked a lot of controversy when skeptics raised questions suggesting that the results were not nearly as impressive as the investigators reported.

Following the initial excitement and discussion we are now starting to get a more measured and realistic view of the drug and the trial. In recent days two important secondary PARADIGM papers have been published. A paper in Circulation looks at the experience of trial participants who didn’t die. A paper in European Heart Journal performs some sophisticated statistical wizardry to estimate how LCZ696 would have performed against placebo instead of an active comparator. It will probably come as no surprise that both papers are highly positive. The Circulation paper shows that LCZ696 was effective in preventing progression of heart failure. The EHJ paper concludes that if it had been compared to placebo in a contemporary, otherwise well-treated population LCZ696 would have produced “striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization.”

Far more important than these papers, in my view, are the accompanying editorials. The Circulation editorialist, Henry Krum, is an influential Australian cardiologist and the EHJ editorialist, Duke University cardiologist Rob Califf, is one of the most influential and respected cardiologists in the world…

Click here to read the full post on Forbes.

 

2014 Dubious Innovations In Cardiology Reply

 

  • Dubious Innovative Device: Renal Denervation
  • Dubious Innovative Business Strategy: Health Diagnostics Laboratory
  • Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine
  • Dubious Innovative Breakthrough Therapy That Never Actually Breaks Through Anything (repeat winner): Cardiac Stem Cell Therapy

 

Click here to read the full post on Forbes.

 

 

European Review Confirms Increased Risk with Ivabradine Reply

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug is not available in the U.S. but is under development by Amgen for the indication of heart failure.

Click here to read the full post on Forbes.

 

 

 

Intent To Tweet And A Failure Of Communication Reply

For more than 15 years I’ve been trying to figure out how physicians can get involved with social media without devolving into Beliebers. It’s not easy. I often joke that the job is a bit like being the social director on a cruise for people with Asperger’s. But here’s the twist: it’s easy to be the social director on a cruise for sorority sisters and fraternity brothers, but you’re not really going to bring anything to the party that they won’t bring themselves. By contrast, those Asperger’s cruisers, just like many doctors, really need help making good use of social media.

A new study published in the venerable medical journal Circulation is a great example of the problems traditional medicine is having trying to figure out social media….

Click here to read the entire post on Forbes.

 

IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe Reply

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo or that LDL might not be a reliable surrogate endpoint. The IMPROVE-IT results will also provide comfort to companies developing the next generation of cholesterol drugs, since their approval may have depended on validation of LDL as a surrogate endpoint.

The  Improved Reduction of Outcomes: Vytorin Efficacy International Trial, presented Monday morning at the American Heart Association meeting in Chicago, randomized 18,144 high-risk patients within 10 days of an acute coronary event to either ezetimibe or placebo on top of a statin….

Click here to read the full post on Forbes.

Cannon

At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs 1

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the McCormick convention center.

Click here to read the full post on Forbes.

Amgen Door Hanger

 

IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine 1

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications.

Click here to read the full post on Forbes.