Pharmaguy's Insights Into Drug Industry News
187.1K views | +31 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"

Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the Amarin court case, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of the drug Vascepa that aren't covered by the drug's FDA-approved labeling -- as long as the information is true and not misleading (read "Amarin Wins Off-Label Case Against FDA"). This case is likely to influence new guidance from the FDA regarding off-label drug promotion by pharma marketers. 

"Might changes in rules for promotion of off-label indications based on free speech arguments lead to a situation akin to crying fire in a crowded theater?," asks authors of Commentary published in the recent issue of JAMA Internal Medicine. The authors of the commentary -- Chester B. Good, M.D., M.P.H., and Walid F. Gellad, M.D., M.P.H., of the Veterans Affairs Pittsburgh Heathcare System -- referred to "compelling evidence" that "off-label prescribing is frequently inappropriate and that prescribing in these circumstances increases the risk for an adverse event substantially."

That evidence was presented in a study published in the same issue of the journal titled "Off-label Prescription Drug Use and Adverse Drug Events" (JAMA Intern Med. Published online November 2, 2015. doi:10.1001/jamainternmed.2015.6058).

What is the "compelling evidence?" Find out here.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

As Amarin Sues FDA Over Off-Label "Free Speech," #Pharma Scientists Scoff

As Amarin Sues FDA Over Off-Label "Free Speech," #Pharma Scientists Scoff | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Won't this be interesting to watch? I'm no constitutional lawyer, but the FDA seems to have lost a few decisions in this area already, and I'm betting that they'll lose this one, too. If they do, then we'll have a pretty lively time of it, sorting out what can and can't be said, but the "can" side will be on top.


Selected comments:


Free-speech and drug promotion are different things. One is to allow opinions, the other to utilize FDA verified facts to sell products. Its hard to feel good about being in Pharma when there is such blatant greed..[and] for GD fish oil!


Wouldn't the old yelling fire in a crowded movie house argument apply here? Basically, speech can be limited by statute in the name of public safety.


Yes, I would have to agree. ... most other Western countries have more limits on free speech and seem to have a lot less of the BS that is continually a source of frustration in the US public sphere. Basically, other free and healthy democratic countries have found ways to put some common-sense limits on free speech without collapsing into police states and communism.


Why bother with those expensive double-blind placebo-controlled trials? Run two of them (PhIII) in a small indication (preferably a lethal one with no SOC). After it's approved, run dodgy open-label studies in much larger indications. Then use your "free-speech rights" to inform the public about this miraculous off-label use. Sounds like the new (maybe only) profitable business plan for Pharma.


Pharma Guy's insight:


This is a sampling of comments to an In the Pipeline blog post that reported about the Amarin suit against the FDA (for background, see here: http://sco.lt/90Sefp 


Most readers of and commenters to this blog - I assume - are scientists working within the pharma industry. Some of the comments are more interesting than the post!

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Pharma Claims Free Speech Rights are Being Trampled in Off-Label Case

Pharma Claims Free Speech Rights are Being Trampled in Off-Label Case | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The latest battle on free speech rights of drug makers hinges on competing views of whether they can distribute materials about unapproved uses of medicines without violating the False Claims Act.
Pharma Guy's insight:


Did you know that even when sales reps are "staying on label" in discussions with physicians, they almost never mention serious adverse events as required by law, not to mention required for "patient benefit"?

A study published online in the Journal of General Internal Medicine shows that sales representatives "failed to provide any information about common or serious side effects and the type of patients who should not use the medicine in 59 per cent of the promotions" (see here).

According to the study abstract:


Serious adverse events were rarely mentioned (5–6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) “black box” warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.


I call this "Free Non-Speech."

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Paid Amarin KOLs Do Not Have "Free Speech," Says Forbes Opinion Piece

Free speech, in the corporate world in general and the pharmaceutical industry in particular, means something quite different from what our country’s founding fathers might have imagined. In this world, “free” speech is paid for, often handsomely, and the companies and people who pay out the money maintain exquisite control over that “free” speech.


At the same time Amarin announced that it had filed its lawsuit it sent a confidential letter (reprinted at the bottom of this story) to physicians who serve on its speakers’ bureau and who are paid to speak to other physicians on behalf of the company. Every company has a similar program for its drugs.


The Amarin letter makes clear that physicians who speak on behalf of Amarin do not have free speech. They must adhere to the strict guidelines of the company. Many of these guidelines are in place to make sure that the talks fall within what the FDA permits the company to say, but many of the talking points represent the company’s best efforts to spin the available data and literature. There is no attempt to present a balanced position representing the views of the company’s critics, for instance.


Amarin’s notion of the first amendment protects and enhances the free speech of corporations but severely limits the speech of individual people.


Pharma Guy's insight:


You can find the complete text of Amarin's "secret letter" to their KOLs here: http://onforb.es/1ASeNx2 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Off-Label Marketing. Has #Pharma Taken The Freedom of Speech Argument Too Far?

Off-Label Marketing. Has #Pharma Taken The Freedom of Speech Argument Too Far? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Whistleblowers. Secretive lobbying. Hushed conversations in the halls of corporate America. Sensational litigation trials. This is the stuff of Hollywood for sure. Actually, it's the stuff of the pharmaceutical industry.


For years the pharma lobbyists have been advocating for the unimpeded flow of information to physicians citing the US constitution's First Amendment as the basis for their thinking. The First Amendment states that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances”. Pretty heavy stuff, no?


So how did our industry end up in the position where the First Amendment and freedom of speech is being used as a shield to allow pharma companies to knowingly disseminate information about their molecules where the long-term safety, tolerability and efficacy data is, at best, unclear? How did we end up with well-heeled lobbyists on Capitol Hill beating the drum vociferously to allow drug representatives to suggest that Topamax which is approved to treat seizures and migraine headaches might be used in alcohol dependency or that Neurontin which is approved for epilepsy might be helpful in bipolar disorder or insomnia ?


Have we taken the freedom of speech argument too far? Are we really comfortable with leading the charge for our drugs to be used in patient populations for which there is no indication and, more importantly, no definitive body of evidence touting their safe use? Is it up to us as an industry to fight this battle? Or are the current regulations around off-label promotion so antiquated, restrictive and over-protective that some coordinated effort is necessary? There is no debate that the off-label utilisation of drug molecules in unapproved indications takes place and, in many instances, gets published or presented at the podium. The question is: who decides what should be shared and who should do the sharing?


The unfortunate part of this debate is that it seems to have turned into a constitutional argument about what ought to be allowed to be said as a matter of principle. It has become a conversation about how manufacturers should be able to have a louder voice and greater role in the dissemination of off-label information. Instead, what's really important is the mechanism by which we get information to clinicians so that they can make treatment decisions that advance care for patients. If that means that industry is removed from the process and we leave clinicians to get this information on their own with some degree of modified or restructured regulatory oversight, then so be it. There are many actors in this play who would not mind one bit.


Pharma Guy's insight:


Everyone is talking about the 2-to-1 split decision by the 2nd U.S. Circuit Court of Appeals in New York, which threw out the conviction of a sales representative for promoting off-label use of a prescription drug. Many pundits believe that the court decision will allow pharma sales reps to exercise their right to freely talk about off-label uses of the products they are selling.

"From our vantage point as digital health communicators," says Michael Spitz of Pixels&Pills Blog, "the ruling has the potential for transforming how the industry connects with its targets, perhaps some day getting us all closer to using the incredible power of digital to deliver the most patient benefit" (see "Free Speech, Fair Balance, and the Future of Pharma").

That's all very well and good. But did you know that even when sales reps are "staying on label" in discussions with physicians, they almost never mention serious adverse events as required by law, not to mention required for "patient benefit"?

A study published online in the Journal of General Internal Medicine shows that sales representatives "failed to provide any information about common or serious side effects and the type of patients who should not use the medicine in 59 per cent of the promotions" (see here).


For more on this, read: Sales Rep "Free Speech" Does Not Include Important Safety Information: I Call this "Free Non-Speech"

more...
No comment yet.