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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Ad Age Ed to #Pharma: "Take a Chill Pill," Dude! Learn from Tobacco Industry

Ad Age Ed to #Pharma: "Take a Chill Pill," Dude! Learn from Tobacco Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[Comments from Ken Wheaton, the editor of Advertising Age]:

 

Are pharmaceutical executives insane or have they simply been dipping into the product a little too much? It's a rude question, I know, but it's one worth asking.

 

I was a little flummoxed by some of the industry "reasoning" put forward in our piece about pharmaceutical companies turning to terror tactics in their marketing (see here; http://bit.ly/2cTKly3)

 

To be clear, no one's confused about why companies are using scare tactics. Because fearmongering works. It's Advertising 101. And there's no better way to monger some fear than "Buy this or die."

 

What's a little confusing is the idea that companies need to get darker with advertising and spend more money on advertising because prices have increased. Are we sure that cause and effect isn't exactly backward?

 

Sure, I get that there is a lot of expensive research and development that goes into making pharmaceuticals that work. And an economist could argue that drug research, manufacturing, pricing and the subsequent marketing all add up to a complex ecosystem.

 

But to the average consumer, or even to politicians, there's no mystery here.

 

Pharmaceutical companies are jacking up prices, and one of the reasons they're doing that is because they're paying for multibillion-dollar ad campaigns used to scare people into buying more drugs. [Pharma spends even MORE – perhaps 5X as much - “motivating” PHYSICIANS to prescribe more drugs!]

 

…In the last couple of years, we've not only seen more scary drug ads, it seems like we're seeing new diseases. It's one thing to say, "Here's a cure for those allergies you've always had." It's another to say, "You've never heard of pneumococcal pneumonia until today, but it might kill your mom." Or: "Sure, you've heard of that meningitis, but have you heard about this other one that might kill your son after he makes out at a party?" (So goes the basic premise for a spot for Pfizer's Trumenba. See here: http://sco.lt/5TxJPl) Or: "Grandma will turn into a wolf and slobber disease all over your baby if she doesn't get this whooping cough vaccine” (see here: http://sco.lt/4pNrKz)

 

That last was from GSK. A spokesperson assured us the wolf was symbolic and it was CGI (you know, because that was the concern). She also said the ad tested well with grandparents. Of course it did. Like I said, fearmongering is a powerful marketing tool. Especially when dealing with grandparents and grandchildren. It's downright genius.

 

My prescription? Just because you can do something doesn't mean you should. Dial back the fearmongering. Don't price-gouge. Don't throw up roadblocks for generics. Show some restraint and listen to complaints.

 

Otherwise, prepare yourselves for the possibility that this particular corner of the marketing world may go the way of tobacco.

Pharma Guy's insight:

Comments on this from Bob Ehrlich, Chairman, DTC Perspectives: "In a world of no DTC, drug makers will still price as high as the market will bear. That is the same strategy used by every business including what Ad Age charges their advertisers. Mr. Wheaton is very convinced in his anecdotal and observational argument. Ad Age’s Mr. Wheaton is wrong about the facts, however, and in his cynicism about the value of drug ads."

 

While DTC advertising alone may have little impact on drug prices, the TOTAL drug promotion budget -- including physician detailing, advertising, and "education" -- adds up to just about what pharma spends on R&D (read my analysis here: “Promotion vs. R&Deja vu all over again!”; http://bit.ly/2csUlBT), which is often used by the industry to justify high drig prices. So, it makes perfect sense to also blams promotional costs for high drug prices, IMHO.

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The Miracle of "Compound" Drug Price Increases a la Valeant & Pfizer

The Miracle of "Compound" Drug Price Increases a la Valeant & Pfizer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In response to intensifying criticism over drug prices, Allergan chief executive Brent Saunders promised not to raise prices by more than single-digit percentage points. So far, no other head of a large drug maker has spoken publicly about this notion or agreed to do the same thing.

 

Yet some companies may adopt this approach quietly — and push the envelope in the process.

 

How so? One way is to raise prices on drugs by 9.9 percent. And this is what Valeant Pharmaceuticals did last week.

 

The drug maker, which has been widely vilified for buying older medicines and then jacking up the prices to sky-high levels, increased list prices for three eye medicines by exactly 9.9 percent, according to Wells Fargo analyst David Maris.

 

Of course, such a price hike pales in comparison to the 525 percent and 212 percent increases Valeant took on a pair of lifesaving heart drugs on the same day the company acquired the medicines in early 2015. But given the public anger over rising costs for prescription drugs, this kind of maneuver is a convenient way to avoid unpleasant scrutiny and still goose revenue.

 

The “9.9 percent increase versus an even 10 percent seems very odd and may be an attempt to stay under the radar of managed care plans and states looking out for double-digit price increases,” Maris wrote in an investor note.

 

He noted the three eye drugs represented just $1.2 million in combined sales in the second quarter, which is a small piece of $2.4 billion in company-wide sales. But the company is under pressure to jump-start revenue, suggesting more 9.9 price hikes can be expected. “While insignificant,” Maris opined, “we believe this may be a sign of things to come.”

 

We asked the company why it chose to raise prices by 9.9 percent and not 10 percent, but did not receive a reply.

 

The 10 percent threshold has taken on more than symbolic weight, though.

 

A bipartisan group of congressional lawmakers last week introduced a bill that would require drug makers to justify their pricing and provide a breakdown of their costs before raising prices on certain products by more than 10 percent. The legislation largely mimics bills that have been introduced in more than a dozen states, although only Vermont has passed such a law.

Pharma Guy's insight:

Conside this: If Valeant were to raise prices by 9.9% twice per year as has been the general practice of other pharma companies (e.g., read “Big #Pharma Pfizer et al Sneak In Multiple Drug Price Hikes Per Year”; http://sco.lt/7Lk8Jd) the results would be an average 23% increase per year. The cumulative effect adds up – for Valeant’s treasury and the consumer pocketbook.

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Big Bad Cough TV Commercial by @GSK Mispronounces Whooping!

Drawing from the classic children’s tale of Little Red Riding Hood, the Big Bad Cough campaign features a wolf disguised as a grandmother interacting closely with her new grandchild. The wolf represents the hidden danger of whooping cough, carried unknowingly by the grandmother.

The Big Bad Cough initiative launched in April 2015 with print and online advertising and was followed by TV ads in June. We are hopeful that this campaign will bring greater awareness to adults, especially new grandparents, so that they can talk to their doctor or pharmacist about whooping cough and vaccination. We have also communicated our support for this important public health issue to the CDC and other key public health stakeholders.

 

[I received this comment from a retired nursing instructor:

 

"In regards to the add about whooping cough from BigBadCough.com: Please have this add corrected if you have anything to do with marketing it. The add is mispronouncing whooping. The add pronounces it with "wh" such as whoopee. The w is suppose to be silent. The add sounds terribly ignorant. It has been pronounced as "hooping" cough for generations. Please do not change it. Just because it is spelled "wh" does not mean it has to be pronounced that way. There are other English words in which the w is silent such as "who" and "whose"."

 

Ha Ha!]

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Infographic: Mortality and Causes of Death: 2015 & 2030

Infographic: Mortality and Causes of Death: 2015 & 2030 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

An infographic using data from the World Health Organization, showing how diseases and causes of death will develop between now and 2030.

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Secret Internal Sales Documents Reveal Abbott's Despicable "Crusade" to Sell OxyContin

Secret Internal Sales Documents Reveal Abbott's Despicable "Crusade" to Sell OxyContin | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sales reps were trying to get through to a doctor to prescribe their potent painkiller. But he wasn’t taking their calls. Then his staff tipped them off: The doctor liked sweets. So they lined a box with doughnuts and snack cakes arranged to spell out the word “OxyContin” and dropped it off at his office. The gambit worked: The surgeon listened to the sales talk. Each week after that, the sales reps were back, asking him to switch more patients to OxyContin.

 

That’s one scene described in a trove of internal documents from Abbott Pharmaceuticals that STAT reporter David Armstrong uncovered in West Virginia. They show how Abbott sales representatives, under a boss who called himself the “King of Pain,” wooed doctors across the country with free meals, free books — and misleading information that downplayed the risk of addiction and had no basis in science. With Abbott's help, OxyContin became a billion-dollar blockbuster — and one of the most abused prescription opioids in the country.

Pharma Guy's insight:

“Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?”; http://sco.lt/6wb24f

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#Pharma Marketers' Fear Tactics in Ads Can Backfire When Perceived as "Jerking Consumers Around to Get Their Money" 

#Pharma Marketers' Fear Tactics in Ads Can Backfire When Perceived as "Jerking Consumers Around to Get Their Money"  | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Fear sells--and pharma marketers have been accused lately of overusing that tactic.

 

First, there was GlaxoSmithKline's whooping cough vaccine ad, which portrayed a sick grandmother as a wolf as she held an infant grandchild. Then, there was Novartis' heart failure awareness ad that showed a room filling with water as an unsuspecting man calmly read the newspaper. More recently, Mylan and Pfizer have jumped into the mix with anaphylaxis and meningitis B ads, respectively, that both feature stricken teens who end up in the hospital.

 

[See this Slideshare presentation for a complete catalog of scary pharma ads: http://bit.ly/ScaryPharmaAds] 

 

Last week, Advertising Age pointed to Big Pharma's “terror tactics." (see here: http://sco.lt/9211nt)

 

One reason for the potential increase in pharma's use of fear tactics? These days, it's harder to get people's attention, given the growing number of media sources. So in advertising--as well as in the news media itself--"more attention-getting approaches are certainly proliferating,” said David Ropiek, a Harvard instructor and author who studies risk perception and risk communication.

 

One thing the recent ads all have in common: They're disease awareness ads that don't promote specific products. Still, using fear as a motivator can also create a negative backlash, both from the media and consumers, whether it is branded work or disease awareness.

 

“The overtness of the scary message, particularly in an advertisement … can raise suspicion in the viewer of mistrust in the messenger--‘I’m not going to buy that because they’re trying to jerk me around to get my money,'" Ropiek said.

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After 30 Years Of Stagnation, Big Pharma Jumps Back In Antibiotics Game. But Is It Too Late?

After 30 Years Of Stagnation, Big Pharma Jumps Back In Antibiotics Game. But Is It Too Late? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Developing antibiotics isn't profitable. But with the looming threat of resistance sparking concerns globally, pharmaceutical companies may be starting to pay attention.

Bloomberg: Inside The 10-Year, $1 Billion Battle For The Next Critical Antibiotic
In a cramped lab in rural Pennsylvania, surrounded by technicians in obligatory white lab coats and fume hoods leaking an occasional acrid smell, Neil Pearson holds up a plastic model of a chemical compound that resembles a spidery piece of Lego. Pearson, a 54-year-old chemist and senior fellow at British pharmaceutical giant GlaxoSmithkline Plc, explains how he spent more than a decade tinkering with chemical compounds before engineering a molecule that may yield the industry’s first truly new antibiotic in 30 years to fight the rise of superbugs that risk killing an extra 10 million people every year by 2050. (Baker, 9/20)

Politico Pro: Antibiotic Resistance Takes The World Stage
The United Nations will hold a high-level meeting Wednesday on antibiotic resistance — placing the largely invisible issue on par with HIV and Ebola as a burgeoning global health crisis. Some predict it will be a breakthrough moment for a growing problem that already kills 70,000 people a year, bringing attention to it in a way that could push the FDA and Congress to take the needed additional steps to end political and regulatory gridlock. Though influence from both the powerful agriculture and drug industries have weakened past efforts, more and more industry groups are at least starting to acknowledge there’s a problem. (Kullgren, 9/21)

The Washington Post: ‘Superbug’ MRSA May Be Spreading Through Tainted Poultry
A new form of a dangerous "superbug" may be spreading to humans through contaminated poultry that people handle or eat, according to a study published Wednesday. Researchers focused on a newly identified strain of the bacterium known as MRSA, or methicillin-resistant Staphylococcus aureus, that they found in people in Denmark. Although most individuals who become infected with MRSA don't get it from food, the study suggests that this poultry-associated strain may be more easily transmitted from food to people. (Sun, 9/21)
Pharma Guy's insight:

Also read “Why Big Pharma Can’t Battle Big Bugs”; http://bit.ly/2db5acE

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Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide

Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gayle Manchin, mother of Mylan CEO Heather Bresch, helped boost sales of the EpiPen in her position as president of the National Association of State Boards of Education.

 

After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented effort that encouraged states to require schools to purchase medical devices that fight life-threatening allergic reactions.

 

The association’s move helped pave the way for Mylan Specialty, maker of EpiPens, to develop a near monopoly in school nurses’ offices. Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the "EpiPen Law" in 2013 gave funding preference to those that did.

 

The CEO of Mylan then, and now, was Heather Bresch. Gayle Manchin is Heather

In October 2012, Mylan sponsored a morning of health presentations at the association’s annual conference. The presentations included a panel described as being on three of the biggest school health concerns, including food allergies.

 

The presenter at the panel, Chicago-based allergy doctor Ruchi Gupta, received more than $400,000 last year from Mylan for research on which she was the principal investigator, according to Centers for Medicare and Medicaid Services records. The center began releasing drug and device makers’ payments to doctors in 2013, when Gupta got more than $17,000 from Mylan for speaking, education, food and travel.

 

About this time, Mylan launched its "EpiPen4Schools” program, which has provided more than 700,000 free EpiPens to 65,000 schools, about half the nation's schools. The New York attorney general's investigation centers on this program, which required schools to buy EpiPens rather than its competitors if they got discounted versions, but Mylan has since changed the policy.

 

In December 2012, the association announced an "epinephrine policy initiative" designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," according to a press release that month. The resulting policy “discussion guide” listed key components that school policies and state legislation should have, including protection from legal liability for the school.

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Much of the Information on Adverse Events Remains Unpublished

Much of the Information on Adverse Events Remains Unpublished | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background

We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events.

Methods and Findings

Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status.

The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in 15 of the 20 pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.

The main limitations of this review are that the included case examples represent only a small number amongst thousands of meta-analyses of harms and that the included studies may suffer from publication bias, whereby substantial differences between published and unpublished data are more likely to be published.

Conclusions

There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events.

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Payers Likely to Pony Up $300,000/yr for Duchenne Drug, But Get No ROI

Payers Likely to Pony Up $300,000/yr for Duchenne Drug, But Get No ROI | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The newly approved Sarepta Therapeutics drug for Duchenne muscular dystrophy will cost about $300,000 a year for the average patient in the United States, which is less than what some Wall Street analysts had expected.

 

Sarepta CEO Dr. Edward Kaye said the pricing was “in the middle of the range” for rare disease drugs. “And given the sensitivity to pricing, we tried to be reasonable when looking at all the costs,” he said on a phone call Monday with securities analysts.

 

Rare disease drugs are defined as treatments for a disease with fewer than 200,000 patients in the US. The average annual cost per patient for such medications rose to $112,000 from $84,000 between 2010 and 2014, according to EvaluatePharma, a research firm.

 

Kaye argued that Sarepta attempted to address pricing concerns while setting the cost for the drug, which will be called Exondys 51. He cited, for instance, the research and development costs the company has so far incurred, as well as future costs for additional trials, some of which are required by regulators.

 

One advocate agreed. “Considering the cost of manufacturing, delivering, and supporting patients [with financial assistance programs], not to mention development costs over a decade, I don’t think it’s too much,” said Debra Miller of CureDuchenne, an advocacy group that also invests in drug makers.

 

The cost is comparable to a cystic fibrosis treatment sold by Vertex Pharmaceuticals, suggesting the price is not out of line, according to Dr. Walid Gellad, the codirector of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

 

However, Gellad also noted that Food and Drug Administration reviewers found the Sarepta drug did not demonstrate a clinically meaningful benefit for patients.

 

“Whether it’s $300,000 or $400,000, there are so few patients [with Duchenne] that payers will be able to pay,” he told us. “But what will they pay for?”

 

Meanwhile, Sarepta hopes to offset some costs with a priority review voucher it was awarded by the FDA as part of the approval. The company can use that to speed review of another drug, which can save time and potentially help generate revenue faster, or it can sell the voucher to another company.

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Ogilvy's Michael Johnston on Using the Familiar - NOT the Scary - in Diabetes Ads

Ogilvy's Michael Johnston on Using the Familiar - NOT the Scary - in Diabetes Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The diabetes category is constantly evolving, and that's what makes it interesting. Over the last 20 years, we've seen many advances in treatment, including thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors.

The science behind these medicines is truly fascinating and underscores how far we've come from the days of purified pork insulin and sulfonylureas. However, a quick look across the advertising landscape shows a mix of creative approaches that remain tied to traditional and familiar executions.

Pharma Guy's insight:

Vaccine ads, however, are scary! 

http://bit.ly/ScaryAdVacc

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Emma Walmsley - Believer in Digital - to Become CEO of GSK!

Emma Walmsley - Believer in Digital - to Become CEO of GSK! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

GSK today announces that Emma Walmsley, currently Chief Executive Officer (CEO) of GSK’s Consumer Healthcare division, is appointed GSK CEO Designate and will succeed Andrew Witty as GSK CEO, when he retires on 31March 2017. Emma will join the GSK Board of Directors from 1 January 2017.

 

Emma is currently CEO of GSK Consumer Healthcare, one of the world’s largest consumer health companies, established in 2015 following completion of GSK’s three-part transaction with Novartis.

 

Prior to this, Emma was President of GSK Consumer Healthcare and has been a member of GSK’s Corporate Executive Team since 2011.  Emma joined GSK in 2010 from L’Oreal where, over the course of her 17-year career, she held a variety of marketing and general management roles in the UK, Europe and USA. From 2007 she was based in Shanghai as General Manager, Consumer Products for L’Oreal China.

Pharma Guy's insight:

Also read: “Who will be the first female CEO in Big Pharma?”; http://sco.lt/7OfnzF I don't think Walmsley was mentioned,

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We DO Need Another Hero: UCB Launches 'Pharma Heroes' Campaign

We DO Need Another Hero: UCB Launches 'Pharma Heroes' Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Standing up to the pharma industry has become political and media de rigueur these days, but who’s standing up for pharma? United BioSource Corp., for one.

 

UBC, a pharma support services company housed inside Express Scripts, is running a marketing campaign dubbed "Pharma Heroes" about its friends in the industry.

 

The in-house campaign--managed internally by senior marketing manager Heather Hawes and graphic designer Erik Allen--launched in January and to date has recognized more than 100 heroes from across the industry at big and small pharma companies, non-profits and healthcare providers. The heroes each receive a plaque and online recognition on the website, and UBC also donates $25 for each one to one of three charitable groups--Cancer Support Community, Global Genes, and International Medical Corps.

 

The idea came from UBC staffers who reported firsthand stories of how medication is changing and saving patients’ lives, Katie Rapp, UBC senior director, strategic market development.

 

“It struck us that these inspirational stories were at odds with the negative industry stories that dominate the news today. If we don’t start to recognize the amazing--and often heroic--work of this industry, then who will?” she said in an email interview. "When we take time to celebrate those who make the pharma industry great, individual contributions are celebrated and the collective impact of their work is elevated.”

 

UBC's efforts complement some of the industry's recent efforts to bolster its image, which has faced several bruising political and consumer flaps in the past year--ranging from the Turing and Valeant ($VRX) price hike scandals last fall to the more current Mylan ($MYL) EpiPen pricing controversy. Pfizer ($PFE) is currently running a corporate TV commercial that explains and celebrates the drug development process from idea to medicine, while industry organizations PhRMA and BIO both began industry reputation-boosting efforts this year focusing on pharmaceuticals’ life-sustaining benefits.

 

As for UBC, it'll run its program “indefinitely,” Rapp said, and it hopes to inspire a movement.

 

“The best thing that could happen would be for similar programs to pop up across the industry and for our collective efforts to first change the way we celebrate ourselves, and then change the way others view the industry,” she said. “Our industry has a tremendous story to tell about the people behind the science of drug development and delivery, and we feel we’re just getting started.”

Pharma Guy's insight:

This is not the first time pharma has tried something like this. Read, for example, “GSK Strikes Back with a Grassroots Campaign”; http://bit.ly/pmn41003h Also, listen to this podcast: “Johnson & Johnson's ennTV: An Engaging Employee News Network”; http://sco.lt/7jkKPp

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Gallery of Scary Pharma Industry Advertising

The scariest pharma branded & unbranded ads seen by & commented upon by pharmaguy.

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Jimmy Kimmel's Mom Makes PB&J for Emmys Audience

Outrage over high drug prices has hit the Emmys. At the awards show last night, comedian Jimmy Kimmel handed out peanut butter sandwiches to the star-studded audience. "If you're allergic to peanuts, uh, well, I guess this is goodbye — because we could only afford one EpiPen," he said. Here's the full clip.

Kimmel was alluding, of course, to the widespread public anger over the cost of the device, which has jumped by 450 percent since 2004. The device's manufacturer, Mylan Pharmaceuticals, will send CEO Heather Bresch to testify before Congress on Wednesday.

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Pharma Industry Capitalizes on “Most Trusted” Status of Nurses to Influence Prescribing

Pharma Industry Capitalizes on “Most Trusted” Status of Nurses to Influence Prescribing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A study by the University of Sydney found Australian nurses attended thousands of industry-sponsored events over four years.

 

Researchers analysed reports from trade association Medicines Australia on sponsored events for health professionals and found nurses attended more than 46,000 in the four years up to September 2015.

 

The study, which was published as a research letter in the journal JAMA Internal Medicine, suggested much more attention had been given to payments from pharmaceutical and medical device companies to doctors to date.

 

“Although a small proportion of nurse attendees had prescribing authority, non-prescribing nurses may have been routinely included in pharmaceutical industry-sponsored events, which perhaps reflects their role in medication compliance, the management of chronic disease, and hospital purchasing,” said the letter.

 

Commenting on the study, Elissa Ladd, associate professor in nursing, and Alex Hoyt, assistant professor in nursing, both from the MGH Institute of Health Professions in Boston, said the findings had “important global lessons”.

 

“The frequent presence of nurses at pharmaceutical company-sponsored educational events indicates they are valued by industry in a way that has heretofore gone unnoticed,” they wrote in a linked commentary in the journal.

 

The two US nurse academics suggested that pharmaceutical companies would not continue to invest in nurses in this way unless there was a good return.

 

“Financial allocation for promotion to nurses most certainly provides a very positive return on investment for the pharmaceutical industry; they would not continue to invest in these activities unless they resulted in favourable financial outcomes,” they said.

 

The industry may see nurses as “very influential” in purchasing or when it came to more informal guidance for patients on treating for chronic conditions.

 

“In addition, nurses without prescribing authority may influence prescribing patterns by steering prescriptions toward the brand-name drug brought by pharmaceutical representatives or suggesting that patients start with samples,” they wrote.

 

Drug companies may well be seeking to capitalise on the fact nursing was the “most trusted” profession, as suggested in a recent Gallup poll, they added.

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Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!

Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests.

 

Dr. Leonard Fromer, a clinical professor of family medicine at the University of California, Los Angeles, just promoted the idea in the prestigious American Journal of Medicine. A handful of groups are preparing a formal request to the government. And Tonya Winders, who runs a patient advocacy nonprofit organization, reached out late last month to crucial lawmakers on Capitol Hill.

 

“We can save lives by ensuring access to these medications,” said Ms. Winders, chief executive of the Allergy and Asthma Network.

 

A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost.

 

An examination of the campaign by The New York Times, including a review of documents and interviews with more than a dozen people, shows that Mylan is well aware of that benefit and, in fact, has been helping orchestrate and pay for the effort.

 

The journal article says it was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr. Fromer. And Dr. Fromer himself has served in the last year as a paid Mylan consultant — which he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Ms. Winders’s organization in particular — to coordinate its strategy, the participants said.

 

The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product. That means they could obtain the medication with no direct cost, regardless of its retail price. Mylan could keep the EpiPen at the current price, or perhaps raise it more, while keeping patient anger at a minimum.

 

Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher co-pays on other drugs.

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Oncologists Not Concerned About DTC "Over Promising" Efficacy, Says @Richmeyer

Interesting day in market research with Oncologists to talk about DTC marketing of Oncology drugs.  Here are some key topline findings:

  1. Majority say that patients are NOT asking for/about specific advertised drugs.
  2. Claims by pharma companies, in ads and in details, are fact checked online with other Oncologists and driven by data rather than brand claims.
  3. Pharma is doing very little to help them help their patients.  They want more educational materials, including “take home” information for patients receiving therapy.
  4. There is a LOT of off-label use driven by contact with colleagues.
  5. They are “not worried” about cancer drugs that seem to “over promise”.  As one doctor said “I want my patients to be optimistic rather than pessimistic when it comes to treatments”.
  6. Biggest concern is “cost of cancer drugs” and that insurer may “tie their hands” when it comes to treatments, especially off-label.
Pharma Guy's insight:

Meyer reports some results from undocumented "research" that seems to discount the viewpoint expressed by two oncologists from Deaconess Medical Center and the Dana-Farber Cancer Institute, Harvard University Medical School; i.e., that Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients. Read more about that here: http://sco.lt/8Imgdd 

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Pharma Not Pleased with UN Panel Report Urging Wider Access to Medicines

Pharma Not Pleased with UN Panel Report Urging Wider Access to Medicines | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After a year of anticipation, the United Nations on Wednesday released a lengthy report that urges governments to take various steps to ensure greater access to needed medicines. And the list contains several proposals that have previously caused struggles with the pharmaceutical industry, suggesting the agency effort may be difficult to actually implement.

 

The report comes amid rising anxiety that too many people in a growing number of countries are unable to afford medications, whether these are the newest salves or older remedies. At the same time, the panel also addresses an equally compelling concern that not enough is being done to develop drugs to treat diseases that predominantly afflict poor populations.

 

Among the recommendations: the UN panel suggested countries should pursue compulsory licenses, which allow countries to sidestep patents and arrange for an alternative version of a medicine to become available. Despite long-running disputes over access, though, governments have shied away from pursuing licenses over concerns about repercussions.

 

A recent high-profile example is playing out in Colombia, where the government made plans to issue a license and sidestep a patent for a Novartis cancer drug. The move prompted US Senate staffers and US trade officials to threaten the Colombian government by withholding support for peace talks with rebels and a trade agreement.

 

Consumer and patient advocacy groups largely praised the UN report. Doctors Without Borders, for instance, called it a “landmark report.” But some complained that the panel did not go far enough in some ways. Beyond encouraging governments to issue these licenses, Health GAP said the UN should have “condemned trade agreements and national laws” that do not make clear that countries have the right to issue a compulsory license.

 

The panel also said countries should require drug makers to disclose certain costs — such as R&D, production, and marketing. The goal is to spur more transparency from drug companies, which have long argued that higher costs justify higher prices. This thinking has also prompted lawmakers in several states in the United States to introduce bills with such requirements, although only Vermont has passed a law.

 

Another recommendation is for companies that receive public funds to publish their research findings. On a similar note, the panel suggested that drug makers should make publicly available all anonymous patient data from completed and discontinued clinical trials. The report recommended data sharing and data access should be a condition for public grants for R&D.

 

The Pharmaceutical Research & Manufacturers of America was not pleased, though. The industry trade group called the report a “a missed opportunity to address the wide array of barriers to access that far too many people face every day.”

 

“As a consequence, the final report focuses narrowly on solutions which fail to recognize and address the complexity of biopharmaceutical research and development and the significant work already taking place to advance access to care. As such, neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system.”

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Is DTC Drug Advertising Effective? More - & BETTER - Research is Necessary

Is DTC Drug Advertising Effective? More - & BETTER - Research is Necessary | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amid the ongoing debate over the wisdom of pharmaceutical advertising, a new [meta]analysis suggests that doctors agree more often than not to write prescriptions for patients who have seen drug ads. At the same time, however, the analysis also found that only 1 in 10 consumers were moved by such advertising to ask a doctor for a prescription.

 

The results present a slightly conflicting picture of the extent to which so-called direct-to-consumer advertising poses an unhealthy dilemma, according to the authors of the analysis, published Tuesday in the Journal of Clinical Psychiatry. While the pharmaceutical industry insists its ads educate consumers, doctors argue some ads too often encourage patients to seek medicines unnecessarily.

 

“I think the data suggests that, if you take a deep dive, we see a mixed bag,” said Sara Becker, an assistant professor of behavioral and social sciences at Brown University, who coauthored the analysis. “Across the board, consumer requests (for prescriptions in response to drug ads) are not happening all that often. But when it does, it raises prescribing volumes.”

 

For instance, one was a randomized, controlled trial that looked only at the effect of advertising on prescribing antidepressants, and actors were hired to role play. The other three were observational studies, including one that examined prescribing a wider variety of medicines in Canada, where drug advertising is not permitted, although many Canadians may well view ads that can be seen in the US.

 

“Our review doesn’t necessarily suggest that advertising is horrible or great,” said Becker. “Although we’re moderately confident that this tells us there can be competing effects on the quality of treatment quality — both better patient adherence and overprescribing. It may have helped in some cases, but less so in others. But more research is needed.”

Pharma Guy's insight:

This is a perennial question & this meta study does not come close to a definitive answer! It's based on four studies across 5 manuscripts & only one is a randomized controlled trial, which used actors playing the role of patients.

 

I reviewed this study back in 2005: “Blame the Doc, Not DTC!”; http://bit.ly/2csIuAS My conclusion was “the research does NOT prove that "marketing of prescription medications for depression may exert significant influence on treatment decisions. Rather it proves that physicians, more often than not, will prescribe a drug if the patients asks for it. That says more about the practice of medicine than it odes about DTC advertising."

 

At the time, the press was making DTC the culprit rather than the physicians. The very first paragraph of an LA Times story stated: "Doctors are easily persuaded to prescribe antidepressants — often unnecessarily — when patients mention having seen them in television advertisements, researchers reported Tuesday.”

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Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign

Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Insys Therapeutics has donated $500,000 to an anti-legalization of marijuana campaign in Arizona known as Proposition 205. Pro-legalization advocates view the half million dollar donation as a further attempt to line the pockets of powerful drug corporations with profits by making it near-impossible for marijuana manufacturers to compete. Insys Therapeutics is a pharmaceutical company responsible for the production of a controversial oral fentanyl spray marketed as Subsys. Fentanyl is a highly addictive, extraordinarily powerful opiate typically used to sedate patients who are undergoing major surgery. The drug is 50 times more potent than morphine. It’s also the same drug responsible for the deaths of Michael Jackson and more recently, Prince. With the ever-growing opioid epidemic in the country, I ask: What could possibly justify a prescription oral spray of such an incredibly risky drug for the treatment of pain when marijuana can effectively (and safely) do the same for far less money?

Insys Therapeutics claims their donation was made out of concern over the safety of marijuana, stating their primary goal is to protect society’s overall health and well-being. That’s pretty interesting considering the company itself is currently under state and federal investigation in relation to its marketing tactics. Six states have already investigated the company’s sales practices, with the state of Illinois having sued Insys in August of 2016 for allegedly promoting the drug to doctors for uses other than those approved by the Food and Drug Administration (FDA). It’s also interesting to note the company is developing its own form of synthetic cannabis; one they say will improve upon a similar drug they used to manufacture which has since been discontinued. It seems quite obvious the company is not too concerned over the safety of cannabis itself but rather, anyone else making a profit from it but them. Their donation is one of the largest ever made to an anti-legalization campaign.

Pharma Guy's insight:

A former sales manager for Insys Pharmaceuticals, which manufactures a highly addictive painkiller (Sunsys Fentanyl - 100X more powerful than morphine) and is under investigation in multiple U.S. states, has pleaded guilty to charges of fraud: http://sco.lt/5f8yLx 

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Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!

Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan, lambasted for raising prices, ranks No. 2 in U.S. drug industry in executive compensation

 

The drugmaker buffeted by the furor over hefty price increases on its lifesaving EpiPen had the second-highest executive compensation among all U.S. drug and biotech firms over the past five years, paying its top five managers a total of nearly $300 million, according to a Wall Street Journal analysis.

 

The big pay packages are unusual because of Mylan NV’s relatively small size in the U.S. drug industry, where it is No. 11 by revenue and No. 16 by market capitalization.

 

Companies generally set their executive pay targets relative to peers in their own industry, with larger companies typically offering more generous pay than smaller ones. Pay also varies somewhat with corporate performance.

 

Mylan’s combined total of $292.1 million in pay for its top five executives over the five years ended last December outpaced that at industry rivals several times its size, according to the analysis, including Johnson & Johnson, Pfizer Inc., Bristol-Myers Squibb Co. and Eli Lilly & Co.

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Defining "Ghostwriting": Drug Industry vs. Academia

Defining "Ghostwriting": Drug Industry vs. Academia | Pharmaguy's Insights Into Drug Industry News | Scoop.it

BMJ Author Alastair Matheson describes how the pharmaceutical publications industry seeks to legitimise ghostwriting by changing its definition while deflecting attention from wider marketing practices in academic publishing

 

During the past decade, the pharmaceutical publications trade has campaigned to persuade medicine, journals, ethicists, and the media that it is opposed to ghostwriting. Yet industry practices have changed little, and commercial drafting of clinical trial reports, consensus statements, and reviews that are authored by recruited academics remains routine. Here, I show that industry’s opposition is based on a redefinition of the term ghostwriting that obscures the continued, widespread use of the practice as originally defined in medical journal literature. I also argue that the ghostwriting debate has deflected attention from the broader set of strategies through which marketing influences medical publications. The use of writers, regardless of whether they are called ghosts, is just one of several options for building commercial perspectives into academic literature, then spinning their attribution to strengthen credibility.

 

As the figure shows, this attempt to redefine ghostwriting is based on two arguments. Firstly, it is claimed that a critical characteristic of ghostwriting is secrecy, and if industry writers are disclosed it should not be considered ghostwriting. The second argument is that the appropriate level of credit is what matters in medical journal articles, and because writers merit only a footnote rather than authorship, they should not be called ghosts when they receive one. In support of this contention, it is argued that composition is technical, not intellectual; that writers are not experts in the subject matter; and, by industry, that academic authors “direct” content and have the final say over the manuscripts that medical writers compose.

Pharma Guy's insight:

Fellow pharma blogger Rich Meyer has said: "Medical journal articles sponsored by drug companies are part of marketing," says Meyer. "That is a fact of a capitalist business that has to market to medical professionals. 'Ghostwriting' has been around for over 20 years and is standard industry practice for the drug industries. I personally see nothing wrong with ghostwriting as long as it is made clear at the beginning of the article who wrote it and who endorses the content." What do you think? Take my ghost writing survey: https://www.surveymonkey.com/r/2V5GR5X

 

Also read: “Saxenda for Weight Loss: A #pharma Ghost Writing Case Study”; http://sco.lt/4y5Ygb

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Which Marketing Channels Have the Best ROI Measurability?

Which Marketing Channels Have the Best ROI Measurability? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Metrics & ROI - Executives say email and search are the two marketing channels for which it is easiest to measure return on investment (ROI), according to recent research from Millward Brown.
Via Brian Yanish - MarketingHits.com
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Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data

Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[About the Author: Harold DeMonaco is a visiting scientist at the MIT Sloan School of Management and a long-time contributor to HealthNewsReview.org.  He has formerly served as the Director of the Innovation Support Center, the Director of Drug Therapy Management and the Director of Pharmacy as well as Chair of the Human Research Committee at the Massachusetts General Hospital.] 

Back in December 2015, Dr. Michael Wilkes wrote a rather thought-provoking blog post on the introduction of an advertising blitz for Bristol Myers Squibb’s (BMS) immunotherapy drug Opdivo. He highlighted the distinct differences between the message delivered by the spot (“A CHANCE TO LIVE LONGER”) and the reality of the clinical trial data. 

BMS began its advertising efforts in late 2015 presumably in an effort to improve sales of what they hoped would be a blockbuster drug that is in direct competition with Merck’s Keytruda. [Opdivo’s sales continue (for now) to climb while the competing drugs have flat or much slower sales growth.]

 

The rationale for the advertising campaign, according to BMS spokesperson Laurel Sacks, quoted in an MM&M report, is “…to educate both patients and their families about new treatment options.” Sacks goes on to say, “Lung cancer is an aggressive, highly stigmatized, difficult-to-treat disease with a high mortality rate and limited advancements in treatments over the past decade. With this in mind, we developed a television advertisement about Opdivo for patients and their families to inform them … and encourage them to have an informed discussion with their physician about available treatment options.”

I’m struck by the high-minded rhetoric of the spokesperson regarding the need to “educate” patients and promote “informed discussions” with physicians. This assumes that the patient’s oncologist has been living under a rock somewhere and has not heard of immunotherapy for cancer. Wouldn’t “A CHANCE TO LIVE LONGER” — if that’s truly what the drug offers — rate high on any physician’s list of discussion topics with patients?

In an email, pharmaceutical industry analyst John Mack, who publishes Pharma Marketing News, also noted a disconnect between the stated objectives of the BMS campaign and its likely impact on patients and families. He observed that in a conference call earlier this year, BMS CEO Giovanni Carforio claimed that television DTC advertising of Opdivo was necessary to counteract the “pessimism” of many patients who “are not being treated as aggressively as they should.” Mack added:

"That leads me to believe the DTC campaign’s goal is to enlist patients to put pressure on physicians to treat them more 'aggressively.' Which could mean that direct-to-physician promotion – i.e., sales reps, CME, etc. – is not working as well as it should and/or clinical trial results/outcomes are not convincing enough docs. The latter has been reported: See “Keynote Speaker at ASCO Says Value of Cancer Drugs Dosen’t Justify the Cost”;http://sco.lt/7XBrbV 

"It almost goes without saying that desperate cancer patients are more prone to believe cancer drug ads, especially those like Opdivo that make extraordinary claims in big bold uppercase letters. Patients will tune out to the side effects that appear toward the end of the commercial and this concerns some oncologists who claim that cancer drug advertising fosters misinterpretation of efficacy by patients. It also concerns the FDA, which is proposing to study such ads."


Opdivo offers no benefit over chemotherapy in early disease

As I mentioned, Opdivo was approved for use in late stage disease, but its value as compared to state of the art chemotherapy in early stage disease was unknown. BMS initiated two clinical trials to answer that question and the results were recently reported. The BMS news release announcing the findings notes, “CheckMate-026 was designed to answer the question of the benefit of Opdivo monotherapy in a broad patient population. Unfortunately, this trial did not meet its primary endpoint of progression-free survival in patients whose tumors expressed PD-L1 at ≥ 5%.”

This brings me back to those principled comments from the BMS spokesperson about “educating” and “informing” patients. I am looking forward to the television ad that informs patients and their families about the failed trial so that they can have an “informed discussion” with their physicians about it. But, I won’t hold my breath waiting.

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Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See pharmaguy.com