Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Benefits of Celebrity Drug Ads Do Not Justify the Cost

Benefits of Celebrity Drug Ads Do Not Justify the Cost | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Do ads in which celebrities discuss specific diseases – but not specific medicines - really influence consumer behavior toward prescription drugs? Although well-known personalities may lend some credibility and prompt consumers to pay closer attention to the messages, a recent study suggests that such advertising does not really make much of a difference when it comes to seeking a medicine.
Pharma Guy's insight:


The authors of the study, which you can find here, conclude that such ads are not worth the cost -- something I blogged about months ago (although I was talking about branded ads) - read 


Pharma: Your Brand Celebrity Spokespersons Are Worthless!


Authors conclusion:


"While consumers paid more attention to the celebrity-containing ads and viewed them as more credible, this did not translate into significant effects on the outcome dependent variables of consumer attitudes toward the ad and company, behavioral intentions and information search behavior. As previous literature has suggested, level of disease state involvement was a significant predictor of respondent outcomes. Overall, pharmaceutical manufacturers might want to re-evaluate using a celebrity endorser in disease-specific ads, as this research shows the benefits/outcomes may not justify the cost."


But brand managers hobnobbing with the glitterati? Priceless!

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Boehringer planning job cuts in Germany

Boehringer planning job cuts in Germany | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Germany's Boehringer Ingelheim has implemented a hiring freeze and plans to reduce its headcount in its home market in a bid to reduce costs.


The news was revealed in German newspaper Frankfurter Allgemeine Zeitung, which cited a company spokesperson who said Boehringer wants to trim its costs by 15 per cent in order to make more money available for investments.


The news also comes shortly after the company agreed a $650m settlement of all state and federal litigation in the US regarding its oral anticoagulant Pradaxa (dabigatran), which focused on the drug's safety.


"We have to create scope for further development, which will enable us to continue to invest vigorously in organic and sustainable growth," said Boehringer's chairman Andreas Barner.

Pharma Guy's insight:


I hope the digital/social media people are not the first to go!

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Data gives credibility, storytelling provides truth in pharma

Data gives credibility, storytelling provides truth in pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Now more than ever, we need to focus on making brands memorable and storytelling is the way to do this.


Every story follows a powerful narrative revolving around:


  1. a central arc (which is a situation or an incident to revolve around your story)

  2. a protagonist (the hero of the story, which should always be the brand)

  3. a antagonist (the villain!)

  4. the resolution (how was the villain defeated in the incident by the brand)


The main characters in any content marketing strategy are your brand and your customers, this is the most important reason for using content marketing personas. These personas allow you to play the role of your customers, showing you are empathetic to their needs. Why is this important? Ultimately this will increase engagement with your brand, as the stories you tell will resonate with them for longer.

Pharma Guy's insight:


I fail to see how fictional patient stories provides "truth in pharma." Some patient stories win awards, but the top award sometimes goes to the made up story and NOT the true patient story (i.e., TRUTH). Read, for example, this post:

Fictional Patient Story Wins Gold, Whereas Authentic Patient Story Wins Bronze at Lions Health 2014

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Pharma Guy's comment, August 6, 2014 6:25 AM
Absolutely, says @Ash_Rishi, author of the original article. "The story should always use real patients, otherwise it will not be authentic!" I said: "With social media there should be plenty of real stories worth sharing by pharma mktrs."
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Docs Complain to CMS About ‘Sunshine’ Data Disclosures

Docs Complain to CMS About ‘Sunshine’ Data Disclosures | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A group of medical societies and pharmaceutical industry trade groups is pushing the government to flesh out data that will be published next month showing how much drug makers pay doctors.


They sent a letter today to the Centers for Medicare and Medicaid Services to ask the agency to explain what context will be provided to help the public understand the justification for payments, such as speaking fees and grants used to bankroll clinical research.


The letter is signed by more than 20 medical societies and organizations including the American Urological Association, as well as heavyweight industry trade groups Biotechnology Industry Organization and the Pharmaceutical Research & Manufacturers of America.


The missive was sent as CMS plans to post the payment data in an online, searchable database as required in the Sunshine Act provision of the Affordable Care Act. The provision was passed in response to concerns that medical practice may be unduly influenced by industry.


The law requires most drug and device makers to report to CMS detailed information about payments and gifts provided to U.S. doctors and teaching hospitals. The disclosures are being made in stages, but September marks the debut when payments will appear publicly.

Supporters of the Sunshine Act say the transparency will provide useful information to patients about the relationships their doctors may have with drug or device makers, and serve as a deterrent to the more extreme examples of industry money unduly influencing medical care.


But some doctors and companies fear payment data will be misinterpreted by the public, or painted with a broad brush. They say there are legitimate interactions that serve to advance medicine, and that doctors should be compensated for services such as consulting for a company about the development of a new product.


Some medical societies teamed up with industry groups to form Partners for Healthy Dialogues, to defend such interactions between industry and doctors, and some of its members signed the letter sent to CMS.


The medical societies and industry trade group lament what they write in the letter is a dearth of context that accompanied CMS’s milestone release of Medicare Part B payments to physicians earlier this year.


Some medical groups say the data did not include context to show which doctors may be abusing the system and which were receiving big payments because of high overhead costs.

Pharma Guy's insight:


A survey revealed that of the more than 1,000 physicians questioned, over half admitted they didn't know that the law requires pharmaceutical and medical device companies to report on expenditures annually, without physician review of the data to correct any inconsistencies or errors, prior to submission to the government. 63% were deeply concerned that a record of these payments will be available in a publicly searchable database.


Listen to this podcast: Physicians Unprepared for Sunshine Law


Questions/Topics Discussed


  • Background regarding the sunshine law, including important dates for implementation.
  • Survey methodology
  • A summary of survey results and what they tell us -- pharma companies might be surprised!
  • How can physicians review the data before it goes public to correct inaccuracies.
  • What is at stake for pharma companies if they do not work more closely with physicians regarding access to the data?
  • What the industry must do to educate their physician clients about the Sunshine Law
  • Will this new form of "Big Data" eventually lead to a significant decrease in payments of all kinds to physicians by the drug industry?


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Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access

Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to the spring 2014 AccessMonitor™ report from global sales and marketing consulting firm ZS Associates, pharmaceutical access to physicians continues to decline. Only 51% of physicians/prescribers now allow access to sales reps, down from 55% in 2013.


The decline in access continues despite the downsizing of the pharma sales force by one-third since 2008. But, the downsizing has actually helped pharma deliver better sales calls.

How? Read the original post to find out.

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Despite Patient Centricity "Buzziness," Recent Pharma Mergers Do Not Serve Patients' Needs

Despite Patient Centricity "Buzziness," Recent Pharma Mergers Do Not Serve Patients' Needs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Yesterday morning, after five spurned bids, AbbVie, the North Chicago-based pharmaceutical giant finally closed in on a deal to buy Irish drugmaker Shire for $54 billion. One key consequence of the deal: AbbVie will change its tax domicile from Illinois to Ireland, reducing its tax rate.


The deal, the largest so called “tax inversion” ever, caps off what feels like an epidemic of acquisitions to escape U.S. taxes in the health care industry.


What is driving the exodus? The U.S. corporate tax rate is now one of the highest in the world, above that of Japan, France, or Germany, and it has not kept pace tax rates in the rest of the world as they have fallen. Unlike other countries, the U.S. taxes revenues made outside its borders, and money held in overseas accounts is taxed if companies want to make use of it in the U.S. Companies like General Electric, Microsoft, Pfizer, and Apple each have more than $50 billion “trapped” overseas as a result of U.S. tax laws that would force them to pay taxes on the money if they spent it in their home country.

Pharma Guy's insight:


Obviously, in this era of so-called "patient centricity" buzziness, these mergers are not undertaken to spur drug development and better serve patients.


"I would argue these mergers have taken a toll on the R&D organization that wasn’t anticipated a decade ago." -- John LaMattina, former Pfizer R&D executive.

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Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians?

Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

These terms are part of the marketing lexicon, which is not shared with pharma marketers' "target" audiences. It's only in the closed, small world of industry conferences, ad agency press releases, and marketers' LinkedIn pages that these terms are seen and heard. Therefore, my guess is that marketing speak has little effect on pharma's reputation among ordinary, every day patients and physicians.

Nevertheless, when pharma marketers use these buzzwords, I take out my "gun" because I, like Spong, do not trust that they are "truly putting patients at the heart of [their] business approach," whatever that means within a capitalistic organization these days. I know what Mr. Merck said about profits follow when the company puts patients first, but these days Big Pharma puts Wall Street interests first.

Pharma Guy's insight:


The industry has "abstained" from using a couple of these buzzwords, at least within topics presented at industry conferences. "Multi-Channel Marketing" and "market access" are still frequently-used terms, but "sales force effectiveness" and "closed-loop marketing" are hardly to be heard nowadays at industry conferences.

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Digital Pharma Marketing: Is the Industry Paying Enough Attention to Mobile?

Digital Pharma Marketing: Is the Industry Paying Enough Attention to Mobile? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Those who access health content are also doing so using more than just PCs. In April 2013, 35 percent of visitors used mobile devices to consume health information. A year later, almost half of health information-seekers used mobile devices to consume health content. This uptick in mobile usage suggests two things: an increased reliance in managing one’s health issues on-the-go, and an increase in tablet usage at home instead of the PC.  For those using mobile devices out-of-home to manage health issues, uses included understanding symptoms, treating a condition, or achieving one’s health goals. Comscore’s research indicates more specifically that on-the-go mobile users seek health information at doctor’s offices and while waiting for prescription refills at the pharmacy.

Pharma Guy's insight:


All the more reason why FDA needs to provide Rx drug promotion guidelines specific for mobile devices.


Read:

FDA's Social Media Guidance Webinar: A Third Guidance Needed for Mobile Devices?
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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:


Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links


FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).


Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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Are Doctors Wary or Weary of Getting Drug Info from Pharma?

Are Doctors Wary or Weary of Getting Drug Info from Pharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
According to a new study from M3, you have an average of about 20 hours a week to capture a doctor’s attention while they’re online.  However, recently, the question hasn't been whether or not doctors areonline, but how do we reach them while they’re online.  Results of the M3 survey show that above all else, credibility may be the biggest factor in getting physicians attention. 

The study, which surveyed just over 1,000 general practitioners, shows that while doctors are spending time online and looking for a variety of information, many are weary [sic; I think the proper word is "wary," although HCPs may be growing tired of of the information being shoveled to them by pharma] of obtaining that information through pharma companies.  While two-thirds of respondents expressed at least some interest in relevant pharma products, a whopping 85% indicated that they prefer independent sources for their information.  In addition, 56% specified that a rep meeting would not be preferable to acquiring information online. 

More “anti-vendor” sentiment can be found in terms of where doctors are spending their time online.  Almost half (45%) said they never visit a device company website when sourcing information while 33% indicated the same for pharma company websites.  Consequently, 59% visit the website of a government body at least bi-weekly in obtaining this information. 

But what can pharma companies do to present themselves as more trustworthy?  Even hard data can often be manipulated and many have a hard time trusting statistics.  Certainly “unbiased” sources of information such as third party reports could be used to a degree.  Respondents also showed some openness to case reports with 39% citing them as useful. 
Pharma Guy's insight:


Quoting Any Yeoman on the LinkedIn discussion of this survey:


"Not sure their unwillingness to visit pharma sites is that closely linked to their level of trust in the industry but more a desire to find impartial information and reviews about the products they buy and use. It's exactly what I do when I am planning a significant purchase.


"The doctors polled in the M3 survey are users of Doctors.net.uk so they have a familiar and trusted platform to engage with pharma-sponsored and 3rd party content. Not all doctors have access to, or use, this facility so the results are not entirely representative. 

"However, the M3 report indicates that many doctors prefer concise information via independent platforms and if these platforms continue to provide the information why are doctors going to change their habits? What can Pharma offer that will catalyse a change in this behaviour? Why bother trying?"

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Ich beim Arzt - Fünf Tipps aus Pfizer

Ich beim Arzt - Fünf Tipps aus Pfizer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Fünf Tipps für Ihr Gespräch mit dem ArztEin gutes Gespräch mit meinem Arzt – was kann ich dafür tun?Unser Crash-Kurs für eine bessere Kommunikation hilft.

Als Patient wünscht man sich Ärzte, die zuhören und alle Fragen, die man in die Sprechstunde mitbringt, in einer patientenverständlichen Sprache beantworten. Doch die Realität sieht leider manchmal anders aus. So manche Patientenfrage bleibt unbeantwortet. Die gute Nachricht: Patienten können selbst viel dafür tun, dass die Kommunikation mit dem Arzt funktioniert.


Unser kleiner Crashkurs hilft Ihnen, sich auf das Arztgespräch vorzubereiten. Das Gute daran: Unsere Tipps für eine bessere Kommunikation können Sie sich leicht merken und später in der Sprechstunde an einer Hand abzählen.


Es lohnt sich. Denn ein gutes Gespräch mit dem Arzt hilft.

Pharma Guy's insight:


(Translation into English with help from Google):


Five tips for your discussion with the doctor


A good conversation with my doctor - what can I do?


Our crash course for better communication helps.


As a patient you wish for doctors who listen and answer any questions that you bring into the clinic, in a patient-friendly language. But unfortunately the reality is sometimes different. Thus, some patients' questions remain unanswered. The good news: Patients can even do much to ensure that the communication is working with the doctor.


Our little crash course helps you prepare for the medical consultation. The good news: You can easily remember Our Tips for better communication and count them off later in the clinic on one hand (when doing so, please note proper German way of indicating #3 with fingers).


It's worth it. A good conversation with the doctor helps.


The Pfive tips from Pfizer are:


  1. Eins: Prepare questions in advance
  2. Zwei: Tell all - dare to ask questions.
  3. Drei: (please note proper German way of indicating #3 with fingers) Demand answers (I think)
  4. Vier: Takes notes
  5. Fünf: Make sure all is clear to you.


I once saw this tweet from @AstraZenecaUS:

"September is National Cholesterol Education Month. See your doctor and visit http://ow.ly/2qo5v for a list of questions to ask."

There are about 16 questions in AZ's list! Given that the average time a patient has with a physician during an office visit is maybe 10 minutes, that's about 38 seconds to ask each question and get an answer! Is AZ kidding? No wonder we don't remember what the physician told us!

One question that AZ left out was "How can I get my personal health record online so that I remember all this and can use it?" 

It's also amusing that AZ suggests you print out the pdf version of its list of questions and bring it with you to the doctor's office. How quaint! Shouldn't there be a "Share This With Your Physician" button on the page so that you can send the questions immediately to your physician before you even see her? Now that's when the online health revolution will truly begin

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Drug Safety Information in the Digital Age — NEJM Finds Fault with FDA & Wikipedia, But Not Pharma

Drug Safety Information in the Digital Age — NEJM Finds Fault with FDA & Wikipedia, But Not Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Internet is increasingly redefining the ways in which people interact with information related to their health. The Pew Internet Project estimates that more than half of all Americans sought health information online in 2013, mostly through search engines such as Google and websites such as Wikipedia and WebMD.


In this digital age, engaging with new media offers an unparalleled opportunity for medical and public health professionals to find information they need and to interactively reach out to patients and their support networks. One domain where these capabilities may have far-reaching effects that are currently undefined is drug safety. As the volume of health-related information on the Internet has grown, important questions have emerged. How are messages from regulators — for example, warnings against using a drug in a specific patient population — diffused digitally? And are the messages still accurate when they reach the general population?


Overall, 23% of Wikipedia pages were updated more than 2 weeks after the FDA warning was issued (average, 42 days), and 36% of pages remained unchanged more than 1 year later (as of January 2014).


Public health officials have historically focused on printed drug labels and “Dear Health Care Provider” letters from the FDA, but new technologies offer the opportunity to reach patients and physicians more efficiently and effectively. We believe the first step should be improving the accessibility of drug information available through the FDA's website.


Another approach to promoting accurate dissemination of drug-safety information is active participation in the online curation of medical information. In 2008, the FDA partnered with WebMD to bring public health announcements to all registered users and to quickly integrate this information into WebMD's suite of Web pages. A digital strategy for drug safety could expand this model to include other sites that are highly frequented by the public, including websites for disease-specific patient-support and patient-advocacy organizations. Our findings also suggest that there may be a benefit to enabling the FDA to update or automatically feed new safety communications to Wikipedia pages, as it does with WebMD.


Pharma Guy's insight:


The authors suggest that FDA work with Wikipedia to edit drug safety information on Wikipedia, but do NOT suggest that drug companies take some responsibility to do this. Perhaps NEJM is reluctant to annoy the hand that feeds (advertises with) them?


For more on my response to this, read: 

Should FDA or Pharma Correct/Edit Drug Information on Wikipedia?
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The Economics of Ebola (and other antibiotic) Drugs

The Economics of Ebola (and other antibiotic) Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it
James Surowiecki on the economics of Ebola drug development. The lack of a treatment is disturbing but predictable. What will persuade pharmaceutical companies to develop unprofitable drugs?


It’s not just developing nations that the system disserves, however.


So how can we get the drugs we need without magically transforming the industry that develops them? The key is to reward companies for creating substantial public-health benefits. And the simplest way to do this would be to offer prizes for new drugs.


Prizes aren’t a new idea—in the seventeen-hundreds, the British government successfully used a prize to find a method for measuring longitude at sea. But, in the past couple of decades, they’ve become more common, with prizes being offered for things like innovations in private space flight.

Pharma Guy's insight:


In a BMJ articled titled "Pharmaceutical research and development: what do we get for all that money?",  the authors' promote a NEW business model for the pharmaceutical industry:

"We should consider new ways of rewarding [drug industry] innovation directly, such as through the large cash prizes envisioned in US Senate Bill 1137, rather than through the high prices generated by patent protection," said the authors.

I was intrigued to learn that a US Senate Bill has been proposed -- although long tabled -- that actually seriously proposed getting rid of patent protection for new drugs as an incentive for innovation. Here's how the BMJ authors describe what SB 1137 proposes:

"The bill proposes the collection of several billion dollars a year from all federal and non-federal health reimbursement and insurance programmes, and a committee would award prizes in proportion to how well new drugs fulfilled unmet clinical needs and constituted real therapeutic gains. Without patents new drugs are immediately open to generic competition, lowering prices, while at the same time innovators are rewarded quickly to innovate again."

The authors assure us that the approach advocated by SB 1137 "would save countries billions in healthcare costs and produce real gains in people’s health."


From: 

New Pharma Business Model: Prizes, Not Patents, for Innovative Drugs
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Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs.

Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new study by researchers from Cambridge Health Alliance/Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen, reveals that drugs released after the 1992 enactment of the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, were more likely to be withdrawn or have a black box warning.


In recent years, the number of warning letters issued by the FDA regarding Rx drugs has dramatically decreased. Some experts claim that this is due to fewer drugs being approved and marketed. However, is it possible that the rise in PDUFA payments -- which now account for about 65% of FDA's budget for regulation of drugs -- discourages the FDA from monitoring drug promotion and issuing warning letters?

Pharma Guy's insight:

 

It could be argued that even as PDUFA fees increased dramatically after 2001/2002, the number of warning letters issued remained pretty flat, which indicates PDUFA had no effect.

 

In 2001 FDA's Chief Counsel at the time was Bush-appointed Daniel E. Troy, who instituted a legal review of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. Hence, fewer warning letters beginning in 2001/2.

The Government Accounting Office (GAO) submitted testimony that documented, among other things, how long it took the FDA to issue regulatory letters citing violative DTC materials during Troy's reign. 

 

For more on this, read: 

FDA DTC Review: The House that Troy Built

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Joel Finkle's curator insight, August 6, 2014 10:09 AM

Do PDUFA fees lead to approvals of unsafe drugs? The chart would appear to refute that.

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Healthcare In Vietnam

Most formerly impoverished countries that engage in a serious round of economic reforms struggle with how and when to prioritize government spending on public healthcare.  The good news is the Vietnamese government is increasing its spending on healthcare and, perhaps more importantly, the country’s emerging consumers are driving demand for western healthcare products, as evidenced by the western brands that now populate the many pharmacies and clinics across Vietnam.  Projections are that over the next five years, Vietnam should enjoy around a 20% compound annual growth rate of pharmaceuticals.  While some of this will be driven by hospital formulary purchases, much of the growth reflects increased appetites for western pharmaceuticals by consumers.  It is estimated per capita health expenditures in Vietnam should increase from$66/year in 2008 to $116 by the end of this year.


Can Vietnam learn from China on how to more efficiently and quickly reform and modernize its public healthcare system than China has been able to?  What role – if any – does the Vietnamese government want the private sector to play in terms of creating new capacity or delivering healthcare goods and services?  Where are Vietnam’s current regulations limiting how multinationals access the market and talk to clinicians and consumers?  Which companies are doing a good job in Vietnam, and what lessons do they have to offer other firms who are either considering a venture in Vietnam, or are looking to expand what they do in the country?  In the coming weeks, we will take a look at these questions and more, all with an eye on how investors can and should think about opportunities in Vietnam’s healthcare market.

Pharma Guy's insight:


But, as in China, will pharmaceutical companies bribe corrupt Vietnamese physicians and hospitals to get them to prescribe their drugs? Vietnam seems ripe for such activities.


For more, read: 

GSK, GSK, GSK: TSK, TSK, TSK!
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We are one step closer to a new generation of cheaper drugs

We are one step closer to a new generation of cheaper drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it
And Obamacare paved the way.


With the high cost of specialty drugs capturing so many headlines these days, here's a bit of a change of pace: A new wave of cheaper drugs marked a major milestone Thursday.


The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive. For example, some biologics to combat rheumatoid arthritis, a disease affecting about 1 percent of the adult population, can cost more than $5,000 a week.


While cheaper generics now dominate the U.S. market for traditional drugs, accounting for about 85 percent of all prescriptions, you still can't get another version of biologic drugs in this country. That's about to change, though, because of a provision included in the Affordable Care Act that provides a pathway for copycat biologics, known as biosimilars, to enter the U.S. market.


The biosimilars' potential for savings in the United States seems to be pretty huge. The pharmacy benefits manager Express Scripts, which has actively advocated for more rapid adoption of biosimilars, estimates that the United States would save $250 billion in health-care spending over the next decade if just 11 biologics had biosimilar alternatives.


Thursday's FDA application from Sandoz is just the first step. The company, which already markets its biosimilar in 40 countries, could gain final FDA approval as early as the first quarter of 2015, according to the Avalare Health consulting firm. With so much concern from health-care payers over a projected rise in U.S. drug spending in the next few years, the development of domestic biosimilar market is something worth watching

Pharma Guy's insight:


Sandoz is the generics division of Novartis. Other pharma companies are fighting tooth and nail to keep biosimilars off the market in the U.S.:..


... such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars"). 

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."


NOTE: Humira topped the list of most advertised brands in 2013. See 

The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital
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Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA

Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), 

her job is to develop federal legislative, regulatory and political strategies. She not only fights criticism of the pharmaceutical industry on multiple fronts, but also promotes healthcare reforms that reflect the industry’s interests.


One current fight involves Gilead’s $1,000-a-pill Hepatitis C drug Sovaldi, which lawmakers, insurance companies and pharmacy benefit management companies say could bankrupt families and the healthcare system.


Even though Gilead isn’t a PhRMA client, the lobby group has come to its defense, saying Sovaldi might sound pricey but in the long run it actually saves money.


While Sovaldi may cost $84,000 or more for an individual patient’s 12-week treatment, Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail.

Pharma Guy's insight:


"Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail."


Let's do the math on Sovaldi, using some numbers from the C. Everett Koop Institute, which may or may not receive funding from Gilead and/or PhRMA:


According to the Institute's data (see Hepatitis C: The Facts) the "average lifetime cost for hepatitis C, in the absence of liver transplant, has been estimated to be about $100,000 for individual patients. Assuming that 80% of the 4.5 million Americans believed to be infected develop chronic liver disease, the total lifetime cost for this group (3.6 million) will be a staggering $360 billion in today's dollars. Assuming an estimated survival of 40 years, the annual health care costs for the affected U.S. population with chronic hepatitis C may be as high as $9 billion."


Saving $360 billion sounds like good news, right? But does the math add up to a savings for payers; e.g., Medicaid, Insurers, States, and patients?

To save that $360 billion, ALL 4.5 million people with Hep C must be treated because doctors can't determine who among the 4.5 million patients will develop chronic liver disease and who won't. At $84,000 "or more" per treatment, the total cost is at least $378 billion! So it's a wash, more or less. Or is it?

On the one hand, Gilead offers discounts to big payers like Medicaid, so the total cost is likely to be much less than $378 billion to treat ALL Hep C patients.

On the other hand, at such a high cost per treatment, it's not likely that ALL Hep C patients will be able to afford treatment and will opt not to take Sovaldi -- especially those patients that do not have and may never have chronic liver disease. Also, we know that even for treatment of life-threatening diseases, patients often (maybe up to 50% of the time) do not comply with the treatment regimen. This may be even more so for drugs like Sovaldi, which are likely to have serious side effects.

So, as far as saving payers money, the Sovaldi math says "maybe." For payers, "maybe" just isn't good enough from a financial, return-on-investment (ROI) standpoint.

Reilly also argues that drugmakers also need a good ROI: "if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

Gilead has racked up $5 billion in Sovaldi sales in the first half of 2014. According to a JAMA viewpoint article, it may have cost Gilead $11 billion to "develop" Sovaldi - this is based on the price Gilead paid to acquire Pharmasset, which discovered and initially tested Sovaldi. If all of the approximately 3.6 million Hep C patients with chronic liver disease in the United States were treated with Sovaldi at current prices, Gilead would net more than $300 billion dollars, or better than a 27-to-1 return on its investment, "suggesting that pricing is inappropriately high." 

At the current rate of sales, Gilead will recoup its initial $11 billion investment by the end of the year and Sovaldi will be profitable in 2015. That's about the time that competition may enter the marketplace. So, Gilead decided price not on what the market will bear, but on how quickly it can recoup its investment before it loses market share and is forced to reduce prices.

Why is PhRMA defending Gilead, which isn't even a member organization?

Here's what Reilly says about that: 

"Reilly pushes back against congressional leaders who are challenging the rising cost of specialty drugs and want the Department of Health and Human Services (HHS) to negotiate down the price of treatments like Sovaldi in Medicare Part D plans. 

"Reilly warns the fight isn’t just about one Hepatitis C drug but future drugs that could save the healthcare system billions of dollars by reducing costs such as chronic care and hospital bills. 

"Reilly also says if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

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FDA Advisory Committee to Discuss Potential of Low-T Drugs to Cause Adverse CV Events

Agenda

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.
 
Meeting Materials
 
FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.  
 
Background Materials 

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before September 3, 2014.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on September 17, 2014.  Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 25, 2014.
 
Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by August 26, 2014.
Pharma Guy's insight:


This should be an interesting meeting considering Health Canada's recently issued warning about these drugs (see here).

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.


Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.


Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 


Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:


At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 

 

Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).


BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch


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Big Pharma Pushes for Off-Label Promotion

Big Pharma Pushes for Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?


For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules against such “off-label” marketing — racking up billions of dollars in settlements. And the Food and Drug Administration has held firm to the idea that sales pitches generally should not include information on uses not approved by the agency.


But in the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike.


Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.


Critics of the current rules say allowing pharmaceutical companies, which know the most about their drugs, to share more information about off-label uses would lead to better-informed physicians and ultimately benefit patients. Others are skeptical, saying the industry could exploit even a minor loosening of the restrictions to hype drugs for unapproved uses, exposing patients to ineffective and potentially harmful treatments.

Pharma Guy's insight:


Some industry officials say the FDA has been slow to adjust to the reality of those court rulings.


“They were in denial,” said John Kamp, executive director of the Coalition for Healthcare Communication, which represents drug marketing agencies and medical publishers. “If doctors can talk to each other and major researchers can talk about off-label uses, the drug’s manufacturer should be able to talk about those uses, too.. . . If something is true and can be said by one party, it can be said by all other parties.”


 Aaron Kesselheim, a Harvard Medical School professor who has studied off-label promotion, asks: Who gets to decide what qualifies as “truthful” information when it comes to sharing data about unapproved drug uses?


What do you think? SURVEY: Distribution of Off-Label Reprints by Pharma: Are FDA's New Revised "Rules" Too Limiting?


Pharma Marketing Blog post: 

WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!
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FDA Regulators Can't Scale To Police Mobile Health Apps

FDA Regulators Can't Scale To Police Mobile Health Apps | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A senior advisor to the FDA said the agency couldn't possibly scale up to meet the challenge of policing the hundreds of new apps appearing every month.


The sheer pace of innovation in the mobile health application space and the numbers of such applications already available on mobile marketplaces like the iTunes App Store and Google Play mean that many mobile health applications will escape scrutiny by federal regulators, said Bakul Patel, a Policy Advisor in the FDA’s Center for Devices and Radiological Health.

Pharma Guy's insight:


Will It Be FDA Regulation or Self-Regulation or Both?


In the early days of the Internet hundreds of health Web sites of questionable quality proliferated without any guarantee of accuracy, lack of bias, privacy, etc. Today, thousands of mobile health apps of unknown quality are available for downloading by healthcare professionals and consumers.

As with Web sites in the early days, it is difficult today for users of mobile health apps to be assured that the apps are reliable, accurate, based on valid information, and adequately safeguard users' information. In many ways, we are living through another digital "wild west" without any sheriffs to protect us.

And it appears that we do need protection. 

Topics include:

  • Inaccurate Health Apps
  • Overzealous FDA Regulation?
  • The Regulation of Pharma Health Apps Survey Results
  • Good App Privacy Practices
  • Test and Document
  • Possibly the First Ever "Dear Doctor' Letter Regarding a Recall Mobile Medical App
  • Certification of Mobile Health Apps
  • Will Regulation Kill Innovation?
  • Self-Regulation: Devil's in the Details


Read this article now. It's FREE...

Download PDF file


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Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Naumann Chaudry, Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).


Unless Dr. Chaudry (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.

Anyone, such as Dr. Chaudry, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).

VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.

But there are even more serious problems with this ad, that, IMHO, should get Dr. Chaudry in hot water with Gilead's CEO and perhaps fired!

Pharma Guy's insight:


What do you think? Should Dr. Chaudry be fired?

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Forget ROI! - Pharma must measure return on engagement

Forget ROI! - Pharma must measure return on engagement | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of the biggest challenges currently facing pharma is the increasing difficulty of not only reaching, but also influencing HCPs through traditional and non-traditional sales and marketing efforts. As we've known for some while, sales forces are getting ever increasingly smaller. In fact a recent study showed that just 27 per cent of sales visits result in the rep actually getting to see a HCP – on the flip side the survey showed only 23 per cent of the HCPs would rate the sales force performance as excellent.


At a time of increased competition, these findings are worrying. Costs are skyrocketing, engagement is decreasing, and the demand for RoI is higher than ever. With responsibility of every penny spent needing to be attributed, the vicious circle of unease continues to swell.


The bottom line is that the way RoI is measured is flawed. HCPs are not loyal to one brand; they could defect to another brand tomorrow. So measuring the investment in a 'campaign' is not the biggest measure anymore. We now need to treat HCPs as consumers. And in consumer marketing capturing brand loyalty has been practiced for decades.


I believe that it is time to drop our over reliance on just chasing those unattainable and arguably, misleading, RoI metrics. It is now the time to look at incorporating relationship and engagement metrics that build loyalty towards a brand.


Pharma Guy's insight:


"Treat HCPs as consumers," "build loyalty" ... if only pharma could offer physicians a "frequent prescriber rewards" program! But wait, the industry used to do just that -- and may still be doing so -- by offering high prescribers "consultant" gigs. In the old days, pharma gave away free trips to medical conferences and free dinners at nice restaurants. Now, with the Sunshine law in effect, it's not so easy to reward physicians that way any more.


The author, Ash Rishi, suggests that pharma adopt consumer practices to "use the power of emotion, to engage, to attract and then to retain customers"; e.g., HCPs. It seems to me that pharma mastered that practice years ago when it started hiring attractive, young sales reps. See, for example, this.


Regarding "each marketing tactic needs to put the patient at the heart of their branding strategies," emotions and loyalty programs are also used by pharma marketers. Just consider the emotional appeal of DTC ads and drug coupon loyalty programs (e.g., read Lipitor For You! Actually, For Card Carrying Members Only!).


Thanks to Rishi I now have another term to include in the Pharma Marketing Glossary: MOT. Rishi doesn't explain what this is, but here is what I learned: It stands for "Moment of Truth," which is a concept coined by Proctor & Gamble.


There are many variations of this term:

  • First Moment of Truth (FMOT) - the actual term first coined by P&G: "This is considered to be the decision point to buy a specific brand or product." (here)
  • Second Moment of Truth - also coined by P&G
  • Third Moment of Truth
  • Zero Moment of Truth (ZMOT) - coined by Google
  • BSMOT - coined by PharmaGuy: Can you guess the meaning?


The term "First Moment of Truth" (commonly called FMOT) was coined by Procter & Gamble in 2005 to define the first interaction between a shopper and a product on a store's shelf. This moment was considered one of the most important marketing opportunities for a brand, as P&G asserted -- and others believed -- that shoppers make up their mind about a product in the first few seconds after they encounter that product for the first time.


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Rich Meyer: Drug companies should build their own online communities

Rich Meyer: Drug companies should build their own online communities | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Can we establish an online community in drug marketing ?

The answer to that is YES.  I did when I worked at Eli Lilly and was in charge of marketing for Sarafem back in 2002.  We allowed people to post their experiences around PMDD but the posts would not go live until they were reviewed by my MLR team. Because of the importance of woman sharing their experiences my MLR team was able to approve the posts within 48 hours and we had a disclaimer that we could edit the post to eliminate not approved FDA claims.


In the first week alone we had almost 300 posts and 99% of them were positive with women sharing their experiences around PMDD and how it affected their lifestyles.  Not only were women sharing their experiences, but in a follow up survey, we found that close to 70% had asked their doctor about Sarafem. This was key because a lot of physicians did not believe that PMDD was a “medical condition” but once we shared the posts from women they quickly became believers.

Pharma Guy's insight:


I appreciate Rich's comments, but he cites old experiences with an online pharma discussion forum. This highlights the fact that the drug industry used to sponsor several of these patient discussion groups in the past -- see, for example, Question Everything --

 but no longer do so. Why not?


Today, there are many more online options available to consumers/patients for discussing their medical conditions and seeking advice from peers. Why would they choose to do this on a pharma site? 


My view is that pharma's reputation has eroded rapidly in the past 10 years (read, for example, the articles in the Pharma Marketing Ethics & Corporate Reputation Compendium). That means, all other things being equal, consumers will opt not to trust pharma and especially not trust whatever is said on a pharma-sponsored site even if it is supposedly from a legitimate patient. Remember, nobody knows you're a dog on the Internet and nobody knows when pharma creates artificial patients to tell positive stories about their products; see, for example, Fictional Patient Story Wins Gold, Whereas Authentic Patient Story Wins Bronze at Lions Health 2014

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