No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize 1

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…

Click here to read the full post on Forbes.

 

 

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Diet Drug Study Crashes And Burns In The Wake Of Leaked Results Reply

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

Prominent Harvard Cardiologist Moves To Google X To Head Large Study Reply

Here’s a clear sign of the ascending role of digital/precision/personalized medicine: a prominent cardiologist has left a top academic and clinical position in Boston to run a large, innovative study in Silicon Valley. Jessica Mega was widely perceived as a rising star at Harvard Medical School and the Brigham and Women’s Hospital. She has now joined Google X, Google’s research arm, where she will head up the much publicized Baseline Study.

“I’m jealous,” said one academic cardiologist at a top hospital, upon hearing the news.

Baseline is one of the ambitious projects undertaken by the life sciences division of Google X….

Click here to read the full post on Forbes.

 

Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech Reply

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use of the drug beyond its current highly restricted FDA-approved indication (see reports in Forbes, the New York Times, and the Wall Street Journal.)

Click here to read the full post on Forbes.

 

 

Precision Medicine Approaches Peak Hype Reply

No, Personalized Medicine Isn’t Going To Save $600 Billion Over 50 Years By Preventing Heart Disease

The hype over personalized medicine has now reached astonishing new heights.  In an article published in the Lancet, Victor Dzau, the new president of the Institute of Medicine, and coauthors write that personalized and precision medicine (PPM) could deliver hundreds of billions of dollars worth of improved health in the US over the next 50 years.

They used a health simulation model to estimate the effect of improved screening and risk prediction to treat people at high risk for 6 diseases: cancer, diabetes, heart disease, high blood pressure, lung disease, and stroke. They then calculated the resulting gains in life expectancy and quality-adjusted life expectancy.

They calculated that reducing heart disease by 50% “would generate a staggering $607 billion in improved health over 50 years.”

Click here to read the full post on Forbes.

 

Victor Dzau

Victor Dzau

 

 

 

 

 

 

 

 

More Evidence Linking Sugared Drinks To Diabetes 1

A new study uncovers some potentially important new details about the association between sugared drinks and diabetes.

In a paper published in Diabetologia [pdf], researchers in the UK report on a study of more than 25,000 adults. Over the course of more than 10 years of followup 847 participants went on to develop diabetes. Instead of relying on a food frequency questionnaire, as in most earlier studies…

Click here to read the full post on Forbes.

 

(Photo by Spencer Platt/Getty Images)

Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care Reply

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.”

Click here to read the full post on Forbes.

 

More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes Reply

More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a mortality benefit. But, the authors and other outside experts warn, the outcome findings should be interpreted with caution until long-term, dedicated outcome studies are completed.

Click here to read the full post on Forbes.

 

Amgen Door Hanger

Inside The Scandal: Profit And Greed At An Embattled Laboratory Company Reply

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.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Tonya Mallory, Former CEO and Co-Founder of Health Diagnostic Laboratory, Inc. in Richmond, Va. (PRNewsFoto/Health Diagnostic Laboratory, Inc.)

Medicines Company Drug Finally Gets Nod From FDA Advisory Panel Reply

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.

Click here to read the full post on Forbes.

 

FDA Approves Amgen Heart Failure Drug Reply

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan.

Ivabradine was approved for the reduction of hospitalization from worsening heart failure.

Click here to read the full post on Forbes.

Corlanor logo

 

 

Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee Reply

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels.

The two trials were the first large large cardiovascular outcomes trials of any diabetes drugs. SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals).

Click here to read the full post on Forbes.

 

Two Dirty Little Secrets About Electronic Health Records Reply

Here are two dirty little secrets about electronic health records (EHR). Just about everyone in the field already knows these secrets, and many are quietly horrified, but few want to discuss them since there are no obvious or easy solutions.EHRs Are a Threat to Freedom of Speech and Academic Freedom

Electronic Health Records Are Not Even Electronic Health Records

Click here to read the full post on Forbes.

 

DOJ Settles With Embattled Lab, Criminal Charges For Executives Still Possible Reply

In line with reports last monthHealth Diagnostic Laboratory Inc, the embattled lab company, has reached a settlement with the Department of Justice following a lengthy investigation into the company’s business practices, which include giving kickbacks to physicians and additional illegal sales, marketing, and billing practices.

HDL will initially pay at least $47 million to the government.

Note to readers: I have received a document from an inside source that provides a detailed snapshot of HDL’s past financial status. I plan to report this information next week.

Click here to read the full report on Forbes.

 

 

Previous Stories About HDL:

Mark Cuban Should Take The Cigar Out Of His Mouth And Stop Giving Health Advice Reply

Last night the celebrity billionaire Mark Cuban ignited a firestorm on Twitter with the following recommendation to his 2.7 million followers:

1)If you can afford to have your blood tested for everything available, do it quarterly so you have a baseline of your own personal health

Led by ProPublica health reporter Charles Ornstein, a slew of doctors, health care experts, patient advocates and journalists tried to show Cuban the error of his ways.

Click here to read the full post on Forbes.

 

Cuban (large)

 

 

Doctors Halt Squabbling And Agree How To Manage Hypertension In People With Blocked Arteries Reply

There’s been a lot of drama in the hypertension field over the past few years. Initially sparked by the decision of the National Institutes of Health to end its sponsorship of national guidelines, the subsequent appearance of multiple guidelines with divergent recommendations led to even more controversy and discussion. Now, however, the appearance of a new scientific statement may indicate that some of the drama is dissipating, at least in one important subset of the field.

The scientific statement from the American Heart Association, the American College of Cardiology, and the American Society of Hypertension covers the important area of the treatment of hypertension in patients with existing coronary artery disease.

Click here to read the full post on Forbes.

 

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.