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 Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the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.

 

Heart Attack Risk Jumps After Divorce Reply

A new study shows that after a divorce people have an increased lifetime risk for heart attacks (myocardial infarction). Although previous studies have found that MIs occur more frequently in people who are divorced, this is the first study to prospectively examine the lifetime relationship between divorce and MI.

In a paper published in Circulation: Cardiovascular Quality and OutcomesDuke University researchers analyzed data from a nationally representative cohort of 16,000 adults who were followed from 1992 to 2010.

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:

Weight Loss Programs: Slim Evidence And Poor Results Reply

A new study concludes that some weight loss programs may be slightly better than other programs but that in the long run none of the programs have been able to show a substantial weight loss over a sustained period. For even the best programs, an editorialist writes, “weight loss is modest and likely below patients’ expectations.”

In a paper published in Annals of Internal Medicine, researchers report on an updated systematic review of studies evaluating weight loss programs…

Click here to read the full post on Forbes.

 

No, You Probably Won’t Drop Dead While Exercising Reply

Dropping dead while exercising is a common fear, especially among middle-aged men. Unfortunately there have been limited data on the precise rate of sudden cardiac arrest (SCA) in middle-aged people and little understanding about the medical history of the victims of SCA. Now a new study fills in some important gaps in knowledge and shows that this fear is largely misplaced, given the small risk that exercise will lead to sudden cardiac death in most middle-aged people.

Click here to read the full post on Forbes.

 

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

 

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)

 

 

Global Cardiovascular Deaths Continue To Rise Despite Gains In Prevention And Treatment 1

Improvements in the treatment and prevention of cardiovascular disease haven’t been able to prevent a worldwide rise in cardiovascular deaths in a growing and aging population, according to the authors of a paper published in the New England Journal of Medicine. Using mortality data from the Global Burden of Disease Study 2013 the authors set out to “disentangle” the effects on cardiovascular mortality of population growth, an aging population, and epidemiological changes (defined as changes in risk factors and the effect of efforts to prevent and treat CV disease).

From 1990 to 2013 the total number of deaths caused by cardiovascular disease increased by 40%, from more than 12 million to more than 17 million a year.

Click here to read the full post on Forbes.

 

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.

 

No, An Apple A Day Won’t Keep The Doctor Away Reply

No, an apple a day does not appear to keep the doctor away. But, a new study semi-seriously suggests, it may keep the pharmacist away. The study serves as an instructive and humorous way to look at the perpetually thorny problem of how to best understand and make use of findings from observational studies. As this new paper makes clear, the limitations of observational studies are quite considerable, but that does not mean that they are completely worthless.

Although apples have long been considered a healthy snack, whether eating apples actually reduces healthcare use has not been assessed until now. In a paper published in JAMA Internal Medicine researchers examined the association between healthcare utilization and apple consumption in more than 8,000 adults participating in the National Health and Nutrition Examination Survey.

At first glance apples appeared to be related to significant benefits…

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:

FDA Grants Premarket Approval To AbioMed Heart Pump Reply

The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures.

The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart function who are undergoing high risk PCI but who are not candidates for surgical revascularization.

Click here to read the full post on Forbes.

 

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.

 

A Requiem for Routine Clot Removal During Heart Attacks Reply

Using a stent to open a blocked coronary artery is the treatment of choice in the early period of a heart attack (myocardial infarction). A limitation is the risk of dislodging part of the clot, leading to new downstream blockages of smaller vessels. One strategy that has been under development for a long time is thrombectomy, in which a device extracts the clot prior to the delivery of the stent. Following earlier success in small trials, the benefits of thrombectomy became controversial when a large trial, TASTE, found no evidence of benefit for the procedure.

TOTAL (Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI), one of the largest trials ever to test a medical device, was presented at the American College of Cardiology meeting in San Diego and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

 

 

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

 

 

 

Encouraging Long Term Results For Less Invasive Heart Valves Reply

The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who were not surgical candidates and then for patients who were at high risk for surgery. One important lingering concern about TAVR was whether its results would prove to be sufficiently durable. Now the final 5 year findings from the trial, published in two papers in the Lancet, provide strong reassurance regarding the durability of TAVR. (The PARTNER trial used the Sapien TAVR device from Edwards Lifesciences. Current TAVR devices are made by Edwards and Medtronic.)

Click here to read the full post on Forbes.

 

New Cholesterol Drugs: Highly Effective But Important Questions Remain Reply

New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine.

The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully, which is what the drugs were designed to do. The situation is less clear regarding the more difficult to ascertain safety and tolerability of the drugs and their long-term clinical effects…

Click here to read the full post on Forbes.

 

 

PCSK9

Marc Sabatine presenting evolocumab results at the American College of Cardiology meeting in San Diego

 

 

Has CT Angiography Lived Up to Its Early Promise? Reply

When it first appeared more than a decade ago computed tomographic angiography (CTA) astounded cardiologists and other physicians. Until it came along the only way to check for blockages in the vital coronary arteries that supply the heart itself with blood was with cardiac catheterization, an expensive, highly invasive and unpleasant procedure. In the following years CTA (the devices are manufactured by GE, SiemensToshibaPhilips and others) enjoyed an explosion of growth, fueled by enthusiasm for its ability to deliver speedy, high-resolution images of the coronary arteries. Many anticipated that CTA would prove its worth and justify its expense and radiation dose. As explained by one cardiologist, Duke University’s Dan Mark, with CTA “only the patients who needed revascularization would actually go to the cath lab and the rest would avoid it,” leading to a reduced use of invasive tests, fewer unnecessary revascularizations, fewer false positives, and, therefore, significant economic advantages. Many years later, however, there is still little agreement about CTA and how it should be used in the diagnosis and management of people with chest pain.

Results of the NHLBI-supported Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE), presented at the American College of Cardiology meeting in San Diego and published simultaneously in the New England Journal of Medicine, provide the best evidence yet for the evaluation of CTA.

Click here to read the full post on Forbes.

 

 

AstraZeneca Drug ‘Approaching The Point Of Diminishing Returns’ Reply

After a heart attack (myocardial infarction or MI) patients remain at high risk for recurrent events. The precise role of blood thinning with dual antiplatelet therapy to lower this risk has been the subject of considerable disagreement.  Now a new study offers fresh evidence that one important strategy, prolonged dual antiplatelet therapy, can lower risk over a long period ;but only at the cost of more bleeding complications.

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.

Study Uncovers Confusion About When To Use An Important Heart Test Reply

Appropriate use criteria (AUC) are designed to help make sure that medical procedures and interventions are performed in people most likely to benefit and, in turn, are not performed in people unlikely to gain benefit. Now a new study published in Annals of Internal Medicine suggests that the AUC for one very widely performed procedure, diagnostic cardiac catheterization, can provide a very rough indication of when it should and should not be performed, but that a great deal more work needs to be done before the criteria can be considered broadly reliable.

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.