Pharmaguy's Insights Into Drug Industry News
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Pharma Industry Reputation Hits 7-Year Low According to Harris Poll

Pharma Industry Reputation Hits 7-Year Low According to Harris Poll | Pharmaguy's Insights Into Drug Industry News |

The line chart illustrates the decline of pharma’s reputation, which puts it on par with its consumer perceptions in 2010 — just before Medicare Part D was legislated and implemented, which improved pharma’s image among American health citizens (especially older patients who tend to be more frequent consumers of prescription drugs).


Further Reading:

Pharma Guy's insight:

Public relations efforts by the industry fails to reverse the trend!

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Pharmaguy curates and provides insights into selected drug industry news and issues.
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How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids

How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids | Pharmaguy's Insights Into Drug Industry News |

In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.


By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.


A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” The DEA had opposed the effort for years.


The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.


The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch (R-Utah) negotiated a final version with the DEA.


As Rep. Tom Marino’s Pennsylvania district was reeling from the opioid crisis, he sponsored a bill that, current and former Drug Enforcement Administration officials say, undermined the DEA's efforts to stop the flow of pain pills. 


For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales.


The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.


Political action committees representing the industry contributed at least $1.5 million to the 23 lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $106 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.


“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”


Further Reading:

Pharma Guy's insight:

No wonder that Pennsylvania Underestimates Death Due to Opioids by More Than Half!: 

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Ad Revenue Drops Sharply in 1st Half of 2017 for Medical Journals - Except Oncology!

Ad Revenue Drops Sharply in 1st Half of 2017 for Medical Journals - Except Oncology! | Pharmaguy's Insights Into Drug Industry News |

Journal ad revenue in the first half of 2017 was down nearly 17% against the year-ago period, but it shouldn't come as a surprise. Two possible reasons: First, established brands with money to spend will continue to spread it across channels, but smaller ones' dollars have shifted to other media. And second, a younger generation of planners aren't as sold on print as their predecessors. Perhaps the most pressing question is whether this is a blip on the radar or the beginning of the end.

See the top 5 journals ranked by revenue, the top 25 advertised brands, and the top 25 advertised categories here.


Further Reading:

“Reports of the Demise of Medical Journal Ads Have Been Greatly Exaggerated”;

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“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing

“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing | Pharmaguy's Insights Into Drug Industry News |

Lori Wallace is dying of breast cancer. As Wallace's cancer has progressed over the past seven years, she has become more critical of what she sees as excessive positivity in health care marketing. It's everywhere: TV ads, radio commercials, billboards. The advertisements feature happy, healed patients and tell stories of miraculous recoveries. The messages are optimistic, about people beating steep odds. Wallace says the ads spread false hope, and for a patient like her, they are a slap in the face.


A couple of decades ago, hospitals and clinics did not advertise much to customers. Now, they are spending more and more each year on marketing, according to university professors who study advertising, and are keeping track.


Wallace pulls up an ad on her computer from UCSF Benioff Children's Hospital, in San Francisco. An announcer intones, "Amid a thousand maybes and a million nos, we believe in the profound and unstoppable power of yes."


There is a similar kind of optimism at the heart of a lot of the ad campaigns by health care providers — with slogans like "Thrive" and "Smile Out." Wallace says the subtext of the ads is that people like her — who get sick and will die — maybe just aren't being positive enough.


Karuna Jaggar is executive director of Breast Cancer Action. She says health care providers are following in the footsteps of other companies.


"It's the basics of marketing," Jaggar says. "In order to sell products or services, you have to sell hope."


She says health care advertisers are adopting the kind of optimistic messaging that really began in force with the pink ribbons and rosy depictions of breast cancer.


The hospital ads Wallace is objecting to tug at emotions, just like other advertising that is trying to win over consumers. With increasing health care costs and choices, patients are shopping around for care. Tim Calkins is a professor of marketing at Northwestern University. These days, he says, hospitals have to sell themselves.


Hospitals are spending more than ever on advertising, he says, and, as with other products, that advertising is filled with lots of promises. He says you don't see the same promises in the pharmaceutical industry. Their ads are regulated by the Food and Drug Administration, which is why they have to list all those side effects and show scientific backing for their claims.


"Hospitals aren't held to any of those [FDA] standards at all," Calkins says. "So a hospital can go out and say, 'This is where miracles happen. And here's Joe. Joe was about to die. And now Joe is going to live forever.' "


Lori Wallace is not going to live forever. Before cancer, she says, she would have been attracted to the messages of hope. But now, she says, she needs realism — acceptance of both the world's beauty and its harshness. She wrote an essay about that for the women in her breast cancer support group.


The essay is titled "F*** Silver Linings and Pink Ribbons." Wallace reads me the whole piece from start to finish. We are sitting at her kitchen table. Her son is nearby with his pet snake.


Toward the middle of the essay, Wallace writes, "My ovaries are gone, and without them my skin is aging at hyperspeed. I have hot flashes and cold flashes. My bones ache. My libido is shot and my vagina is a desert."


"That's what I wrote," Wallace says. "That's what I wrote. Brutal honesty."


Further Reading:

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Only Half of New Cancer Therapies Help Patients Live Longer

Only Half of New Cancer Therapies Help Patients Live Longer | Pharmaguy's Insights Into Drug Industry News |

Only about half of the cancer drugs approved by the European Medicines Agency in the last few years were later shown to help patients live longer or improved their lives, a new study says.


Scientists in Britain and Latvia analyzed reports from the European regulator on cancer approvals from 2009 to 2013. Many of the approvals were based only on initial measures that suggested the drug might improve health, like tumor shrinkage.


During that time, the EMA green-lighted 48 drugs for 68 different uses. Of those, the researchers determined that 35 approvals significantly improved patient survival or their quality of life, while data for 33 uses were “uncertain.”


Many regulators, including the U.S. Food and Drug Administration, often OK drugs based on initial surrogate measures because it can take many years before solid data about the drugs’ effectiveness exists. In the study, 39 of the 68 approvals relied on surrogate measures.


“We were quite surprised about the high proportion of drugs entering the market without evidence,” said Huseyin Naci, of the London School of Economics and Political Science, one of the study’s authors.


Further Reading:

“Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”;

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"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic

"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News |

Former Mississippi Attorney General Mike Moore, who famously led a campaign to punish tobacco companies for lying about the dangers of smoking, has set his sights on the pharmaceutical industry, according to Bloomberg Businessweek.


Moore, a University of Mississippi alumnus who served as the state’s attorney general from 1998 to 2004, was the first state AG to file a lawsuit against Big Tobacco and won the largest corporate settlement in history—$246 billion for 50 states, with the money earmarked to fund smoking cessation and prevention programs.


Since exiting the political sphere, Moore has continued to practice law with two partners in the Mike Moore Law Firm, headquartered in Flowood. But the national opioid epidemic has brought him back into the media spotlight.



When his nephew nearly died of an overdose of fentanyl—a powerful synthetic analog to the opium poppy and the drug that killed Prince—Moore decided the legal strategy that had proven so successful against the tobacco industry could also work against pharmaceutical companies. In the case of Big Tobacco, a coalition of state attorneys general, led by Moore, bombarded companies like Phillip Morris and RJ Reynolds with individual, costly lawsuits, forcing them into negotiating a single—and massive—settlement rather than fighting each suit separately.


Bloomberg Businessweek hailed Mississippi AG Mike Moore as the “Opioid Avenger.”


According to Bloomberg Businessweek, Moore and his legal team have assembled another coalition, including 10 states and dozens of counties and cities, to file suits against pharmaceutical companies like Purdue Pharma, Endo and Johnson & Johnson’s Jannsen Pharmaceuticals. All totaled, 40 states are looking into the viability of launching their own suits

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California Delivers Blow to Pharma: Requires Drug Price Transparency

California Delivers Blow to Pharma: Requires Drug Price Transparency | Pharmaguy's Insights Into Drug Industry News |

In a blow to the pharmaceutical industry, California Gov. Jerry Brown on Monday signed a bill into law that requires drug makers to explain and justify price hikes, making this the latest state to actively address the high cost of medicines.


The bill, which was vociferously fought by the pharmaceutical industry, is set to become one of the more comprehensive state efforts to address pricing transparency.


For instance, drug makers have to provide 60-day notice to insurers and government health plans before increasing list prices of any medicine that costs more than $40 by at least 16 percent in a two-year period. And health plans have to provide detailed information about prescription drug costs and the portion of premiums attributed to this expense. (Here is a fact sheet on the bill.)


“Californians have a right to know why their medical costs are out of control. This measure is a step in bringing transparency, truth, exposure to a very important part of our lives – that is, the cost of prescription drugs,” said Brown at a ceremony where he signed the bill into law, which goes into effect on Jan. 1 (you can watch the ceremony here).


“It’s a monumental achievement for the entire nation,” state Sen. Ed Hernandez said last month after the state legislature sent the bill to Brown. The legislation “will set national health care policy, having impact for consumers and providers in other states.”

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Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media

Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media | Pharmaguy's Insights Into Drug Industry News |

Belsomra's furry word creatures have officially retired. Merck & Co.'s "sleep" cat and "wake" dog in the insomnia drug's first wave of TV ads are giving way to a new empathy-oriented campaign that builds on sleepless patients' personal frustrations.


In a new TV ad begun last week, a woman turns off her television, shuts the curtains, dims the lights and turns off her phone before lying down to sleep. But one by one, the devices turn themselves back on to keep her awake.


“The original ad served its purpose. We were a very late entrant to the market, and at the time, the team felt we needed to break through,” said Doug Black, U.S. marketing leader for insomnia at Merck. “What we’ve learned since then as we’ve listened to our consumers, is that to reach a broader audience, we needed to find a more empathetic message.”


The original ad did “tremendously well” in launching the brand, he said, but the time had come for a change to the more empathetic and customer-focused message.


Another change is the emphasis on mechanism of action (MOA). In the furry creature words ad, there was a dedicated push to explain the market-differentiating MOA for Belsomra versus that of competitors already on the market. Now, Merck is backing off MOA as a focal point, although the marketing does still mention its differences.


Black explained the change to focus on efficacy “because ultimately, for a broader audience, efficacy is the main driver. … If the product doesn’t work the way you want it to, it doesn’t matter what the MOA is.”


The TV ad will run selectively, he noted, with the bulk of Belsomra’s ongoing effort in digital. Thanks to the earlier campaign and market experience since the drug's launch in 2015, the brand team has learned how to craft and optimize its digital media mix to reach potential patients all along their journeys, Black said.


Further Reading:


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Women of Color in Pharma Marks Official Launch with First Annual Conference

Women of Color in Pharma Marks Official Launch with First Annual Conference | Pharmaguy's Insights Into Drug Industry News |

Women of Color in Pharma (WOCIP) today announced that its official launch will take place at the WOCIP first annual conference, scheduled for Sunday, November 5 and Monday, November 6, 2017 in Princeton, N.J. WOCIP is a professional society focused on fostering the growth and development of Black and Latina women in the pharmaceutical industry. WOCIP enables the cultivation of a sustainable pipeline of Black and Latina women leaders who, together, can harness the power of their diverse expertise, bringing a competitive advantage to industry.

"WOCIP's vision is to enable the transformation of the pharmaceutical professional landscape with women of color," said co-founder Charlotte Jones-Burton, M.D., M.S. "Our mission is to empower women of color in pharma to excel in their personal and professional development and to transform their pathway within the pharmaceutical industry."

Speakers at the first annual conference include representatives from pharmaceutical companies and contract research organizations. Wanda Bryant Hope, Chief Diversity Officer for Johnson & Johnson, will deliver the keynote address. Other speakers include Michelle Amador of Covance, Marisa Co of Bristol-Myers Squibb, Cristina Santos of Sanofi, and Celeste Warren of Merck. The conference is co-sponsored by Bristol-Myers Squibb and Novo Nordisk, with generous support from Covance.

"The conference theme is 'Get Inspired. Be Empowered,'" said co-founder Patricia Cornet, M.A. "We welcome colleagues in the pharmaceutical industry who are interested in engaging in professional development, networking and discussing key areas that are shaping the pharmaceutical landscape for WOCIP to join us."  

The Conference opens with a welcome reception on Sunday, November 5 at 6 p.m. at the Hyatt Regency in Princeton, N.J. The full-day conference is Monday, November 6 at 8 a.m. at the Novo Nordisk Inc. training facility in Princeton, N.J. To register, visit the WOCIP website

About Women of Color in Pharma (WOCIP)

Women of Color in Pharma (WOCIP) is a 501(c) (6) non-profit corporation whose purpose is to promote the development and advancement of women of color who are employed in the pharmaceutical industry. Founded in March 2015 by Charlotte Jones-Burton, M.D., M.S. and Patricia Cornet, M.A., WOCIP has an informal network of approximately 500 members and is supported by member dues and corporate sponsors. For more information, please visit

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Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines

Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines | Pharmaguy's Insights Into Drug Industry News |

Allergan’s Botox, which the company has called a “pipeline in a drug,” has delivered again.

On Tuesday, the FDA approved the blockbuster product to temporarily improve the appearance of certain forehead lines in adults. The green light marked the med’s third cosmetic indication—it also bears go-aheads to treat crow’s feet and glabellar lines—and makes it the only neurotoxin that can boast approvals in three separate facial treatment areas.

The approval presents another opportunity for Allergan in an aesthetics market that company CEO Brent Saunders has called the best market in the world.

“It's high-quality, it's cash-pay, it's global,” he said on this summer’s second-quarter earnings call. “We are just at the initial stages of market development in the U.S. and almost every market in the world. So we have very high conviction around the sustainability,” he added.


Further Reading:

  • “Allergan CEO Brent Saunders is Not Just a Botox Fan, He's Also a Botox User!”:
  • Botox, the Swiss Army Knife of Drugs, Featured on Cover of Time Magazine”;
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Whoops! STATnews Forced to Retract Op-Ed Ghostwritten by Industry-Funded Alliance for Patient Access

Whoops! STATnews Forced to Retract Op-Ed Ghostwritten by Industry-Funded Alliance for Patient Access | Pharmaguy's Insights Into Drug Industry News |

In an era of widespread calls for action to tame skyrocketing prescription drug costs, one organization consistently opposes measures to rein them in: the Alliance for Patient Access (AfPA).


The AfPA claims it’s trying to ensure patients have access to FDA-approved therapies. However, its track record shows it pushes platforms that help drug companies’ bottom lines. frequently writes about how patient advocacy groups are co-opted by drug industry funding, but the AfPA is something different, observers say: a front group established solely to do the bidding of industry.


To advance its agenda, the AfPA often uses politicians and the news media, and rarely are its deep pharmaceutical connections called out.


Recently, for example, STAT ran a ghostwritten op-ed piece from an AfPA board member that extolled a $24,000-a-year drug to treat psychosis related to Parkinson’s disease. The op-ed was retracted after discovered and reported that it was ghostwritten.


Asked about STAT’s participation with the AfPA and other industry partnerships, Executive Editor Rick Berke told Managing Editor Kevin Lomangino: “Every partnership we enter into, we think about the optics and appearances. We’re comfortable with the decisions we’ve made. They may not be up to your standards but they’re up to our standards.”

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He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent

He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent | Pharmaguy's Insights Into Drug Industry News |

His face is everywhere: in TV commercials during late-night comedy shows, in the pages of Wired and Politico, on a billboard at the airport near Washington, D.C.


Brian Kursonis, who was diagnosed last year with early-onset Alzheimer’s at age 55, is a star of the drug industry’s “Go Boldly” campaign — a sophisticated PR push, costing tens of millions a year, to highlight pharma’s commitment to develop cures for dreaded diseases.


The ads might improve pharma’s battered reputation. But behind the soft lighting and inspiring music, the patient who’s helping anchor the campaign says his life is falling apart.


He is living alone, after a nine-year relationship broke up as his memory deteriorated. He had to give away his beloved dogs. He loves fly-fishing, but forgets how.


And he is fast running out of money.


Kursonis hopes he can find a way to earn a living as an advocate, but if money doesn’t come in soon, he won’t be able to make the December rent on his spartan apartment in a suburb outside Charlotte, N.C. He fears he will soon be homeless, his best option the men’s shelter in downtown Charlotte.


Kursonis’s story highlights the complicated, often heartbreaking realities that compound the challenges of living with a disease like Alzheimer’s.


In the “Go Boldly” ads — which were funded by the drug industry lobbying group PhRMA — he’s paired with a scientist who promises to bring an Alzheimer’s drug to patients in her lifetime. Even if she succeeds, a long shot in a field that has been marked by failure after failure, Kursonis knows it will likely be too late to help him and millions of other patients in the grip of the degenerative disease.


Now, he’s begun speaking candidly about his challenges — both on his blog and in interviews with STAT — in hopes of raising awareness and building a new career as a patient advocate.


“I want people to know, if I disappear, that at least I tried,” Kursonis said.


Further Reading:

Pharma Guy's insight:

The only option is for him to become a paid Alzheimer's patient advocate. Good luck with that! There will be many more patients vying for that opportunity.

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Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine

Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine | Pharmaguy's Insights Into Drug Industry News |

A UK company has started trialling a new universal influenza vaccine that would avoid the annual scramble to guess the most likely strains to be circulating in the following flu season.


The vaccine - developed by University of Oxford spin-out Vaccitech - will be tested in around 500 National Health Service (NHS) patients in a study supported by the National Institute for Health Research (NIHR). It is thought to be the first trial of such a vaccine and will extend over the 2017-18 and 2018-19 flu seasons.


The need for a more effective flu vaccine was starkly revealed last winter. The recommended vaccine was around 40% effective overall, but hardly provided protection at all to the over-65s who are most at risk of severe complications and death from the infection, despite being a good match for circulating strains of the virus.


The NIHR notes that flu affects about a billion people worldwide a year with 250,000 to 500,000 annual deaths, mainly in the over-65 age group. About 10,000 over 65s registered at six GP practices will be asked to take part in the trial in Berkshire and Oxfordshire this winter.


The new vaccine is designed to offer greater protection against flu because it targets the core proteins of the virus, which stay constant, while current vaccines target surface proteins (haemagglutinin and neuraminidase) that are constantly changing.


Further Reading:

Pharma Guy's insight:

I was involved tangentially in research to develop a universal flu vaccine way back in the early 80s (see further reading). The image shown here is of a molecular model I built of the core protein of the flu virus.

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The #Pharma Marketing Salaries Roller Coaster Ride - Ready for the Next Big Dip?

The #Pharma Marketing Salaries Roller Coaster Ride - Ready for the Next Big Dip? | Pharmaguy's Insights Into Drug Industry News |

Welcome to the 31st MM&M Career and Salary Survey, which brings tidings both welcome (salaries are up) and somewhat less so (the gender gap hasn't narrowed much). Buckle up — there's lots of ground to cover.

As with any survey of this nature, the headline data are always the ones related to salary. Based on conversations with marketing higher-ups at pharma companies and agency leaders, we expected to see some salary inflation from a year ago. What we didn't expect was the sizable percentage jump: the average base salary exclusive of bonuses or commissions increased a stunning 12.7%, from $139,200 last year to $156,900 this year (see Fig. 1). And 67% of respondents reported receiving a bonus on top of that.

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Baby Boomers Make Fools of Themselves in Patti LaBelle "Prank" to Promote Pfizer's Pneumonia Vaccine

Baby Boomers Make Fools of Themselves in Patti LaBelle "Prank" to Promote Pfizer's Pneumonia Vaccine | Pharmaguy's Insights Into Drug Industry News |

Pfizer has tapped a legendary singer to raise awareness about the risk of pneumococcal pneumonia for older adults. In an online video, Patti LaBelle plays judge for a fake backup singer audition. Baby boomer singers take the stage to perform, but there's one catch: The microphones have been rigged to make it sound like the singers have pneumococcal pneumonia, with coughing and wheezing overtaking their songs.


LaBelle clues in the singers with an “I got you,” while a voiceover explains the risk for people over 65 and encourages them to get a “new attitude”—one of LaBelle’s most popular songs—and talk to their doctor about vaccination.


The awareness effort is called “All About Your Boom,” and it will appear online at the campaign website as well as on social channels, including Facebook and YouTube.


Pfizer chose LaBelle, 73, because “she embodied what it means to be a boomer. … She wants to remind fellow boomers that a big part of staying healthy that is often overlooked is staying up-to-date on CDC-recommended adult vaccinations,” the Pfizer spokeswoman said.


The campaign comes as flu season begins, a time when many people aged 65 and older go to their doctor for a flu shot, so the reminder to ask about the pneumonia vaccine is meant to coincide with that, she said.


Pfizer’s vaccination for pneumococcal pneumonia is Prevnar 13, which in branded TV advertising has tallied $30.3 million in national spending so far this year, according to data from real-time TV ad tracker The bulk of that was spent in the first four months of the year, with a break for the summer, and ads just recently came back on the air at the beginning of September.


Further Reading:

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FDA Makes Side-Effect Database Searchable

FDA Makes Side-Effect Database Searchable | Pharmaguy's Insights Into Drug Industry News |

If you had a bad reaction after taking a medicine, there’s now an easy way to find out whether others experienced the same.

The U.S. Food and Drug Administration improved its online database of reports about side effects filed by patients and doctors, making it easily searchable by product, patient age, type of side effect or year it occurred.

It means that, for the first time, the public will have access to data it can make sense of. Previously, inquiring minds needed to know a little about coding to figure out the FDA’s adverse-reaction database. And even then, they had to file a Freedom of Information request with the government to get the actual reports and check the information’s accuracy.

The FDA said it hopes that the increased transparency will spur patients and doctors to submit more detailed and complete reports. Many patients don’t even know they can submit adverse-event reports to the agency.


Further Reading:

  • "Institute for Safe Medicines Practices Calls for a Full-scale Modernization of FDA’s Adverse Event Reporting System";
  • “So Far, FDA’s Sentinel Drug Safety Monitoring Initiative Has Not Delivered as Hoped”; 
  • “OpEd: FDA's Antiquated Drug Safety Program is ‘Obscene’"; 
  • “Another Aspect of Patient Power: Making It Easier to Report Adverse Events!”; 
  • “More Than 1 Million Adverse Event Reports Were Sent to FDA in 2015 – Only the Tip of the Iceberg”; 
  • “Deregulation and Budget Cuts Likely to Lead to Increased Adverse Event Reporting”; 
  • “FDA's Dependence on User Fees & ‘Institutional Corruption’ Blamed for Dramatic Increase in Drug Adverse Events and Deaths”; 
  • “#FDA Blames Computer Glitch for Hundreds of Errors Found in Essure Adverse Event Reports”; 
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Bees Hack EpiPen’s Database Of Everyone Who’s Allergic To Bees! What Do They Plan to do with the Data?

Bees Hack EpiPen’s Database Of Everyone Who’s Allergic To Bees! What Do They Plan to do with the Data? | Pharmaguy's Insights Into Drug Industry News |

If you or someone you know has a bee allergy, you need to read this right now.

Large consumer data hacks have had devastating impacts on countless Americans, but this recent leak may be the most serious yet: EpiPen’s database of everyone who is allergic to bees has been obtained by bees.

This is absolutely sickening.

EpiPen is scrambling after discovering the breach in its system a few hours ago, and company officials are advising all customers to stay inside until further notice while they figure out just how much data the bees have now. They are also recommending that severely allergic people place towels under their doors and keep their EpiPen primed and hovering just above their thigh with their back to a wall for safety.

“We do not know what they plan to do with it, but we can confirm that bees have a list of everyone who has ever purchased an EpiPen,” reads a prepared statement published on the company’s website. “Bees have your information now. We are very sorry.”

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PhRMA Says Limiting Prescriptions of Opioid Painkillers "Right Thing to Do"

The pharmaceutical industry now supports limiting prescriptions of opioid painkillers to a seven-day supply for acute pain management, PhRMA CEO Stephen J. Ubl announced Wednesday at a meeting of the White House’s opioid abuse commission.


“Too often, individuals receive a 30-day supply of opioid medicines for minor treatments for short term pain,” Ubl said. “Overprescribing and dispensing can lead to patients taking longer than necessary and excess pills falling into the wrong hands.”


The trade group PhRMA’s announcement follows steps by some pharmacy benefit managers to restrict the supply of opioids to first-time users, as well as new prescribing rules set by states — all part of the burgeoning effort to fight the opioid epidemic.


Ubl acknowledged that PhRMA’s recommendation could be seen as drug companies interfering with patient and clinician choices, alluding to the broader debate that efforts to limit pain pills are hurting patients who can no longer get the treatment they and their doctors feel they need. But he said in this case, it was a necessary step.


“We’ve always supported physician autonomy and the preservation of the physician-patient relationship, Ubl said, “but as you know, given the scope of this crisis, we believe it’s the right thing to do.”


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Right After Trump Blamed High Drug Prices On Campaign Contributions, #Pharma Gave More

Right After Trump Blamed High Drug Prices On Campaign Contributions, #Pharma Gave More | Pharmaguy's Insights Into Drug Industry News |

“The cost of medicine in this country is outrageous,” President Donald Trump said at a rally in Louisville, Ky., two months after his inauguration. He went on about how identical pills have vastly lower price tags in Europe (read “Trump's Comments Are Big Pharma's Nightmare”;


“You know why?” the president asked, before spreading his hands wide. “Campaign contributions, who knows. But somebody is getting very rich.”


It was March 20, 2017.


The next day, drugmakers donated more money to political campaigns than they had on any other day in 2017 so far, according to a Kaiser Health News analysis of campaign spending in the first half of the year reported in Federal Election Commission filings.


This KHN story also ran in HuffPost. It can be republished for free (details).

Eight pharmaceutical political action committees made 134 contributions, spread over 77 politicians, on March 21. They spent $279,400 in all, showering Republicans and Democrats in both legislative bodies with campaign cash, according to FEC filings. The second-highest one-day contribution tally was $203,500, on June 20.


  • Further Reading:
  • Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations;
  • “Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare”;
Pharma Guy's insight:


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"Key Opinion Leader" (KOL) is the Most Commonly Used Term by Pharmaceutical Industry

"Key Opinion Leader" (KOL) is the Most Commonly Used Term by Pharmaceutical Industry | Pharmaguy's Insights Into Drug Industry News |

The Medical Science Liaison Society (MSL Society), the only 501(c)(3) non-profit organization exclusively dedicated to advancing the global medical science liaison (MSL) profession, has released the results of a first-of-its-kind global survey among MSL and Medical Affairs professionals regarding the most common term used to describe the physicians and other health care providers, whose opinions are highly regarded, and who influence other physicians.


The survey included 473 respondents from 54 countries and consisted of Executive Management/VP's of Medical Affairs, Manager/Director of MSLs, Medical Science Liaisons, Medical Advisors, and MSL trainers. Respondents also identified their company type as either Large pharma, Medium pharma, Small pharma, Biotechnology, Contract MSL Organization, CRO, Diagnostic Company, or Medical Device.     


A key finding from the survey is that 60 percent of respondents from pharmaceutical companies reported that their company uses the term Key Opinion Leader (KOL).


Other key findings include:


  • 62 percent of respondents from all company types reported that their company uses the term Key Opinion Leader (KOL). This was followed by External Expert (8 percent) and Thought Leader (7 percent).
  • 42 percent of all respondents thought that Key Opinion Leader was the most appropriate term. This was followed by Thought Leader (14 percent) and Medical Expert (13 percent).
  • 63 percent of all respondents thought that the healthcare industry should use a single universal term.


Dr. Samuel Dyer, CEO of the MSL Society, stated: "While there is considerable discussion within the MSL and broader Medical Affairs community of whether Key Opinion Leader is the right or best term to use, this survey reveals for the first time that the majority of companies utilize the term KOL, and the second most common term is used by a very small percentage of companies." 


Dr. Dyer also added: "It's clear from the data that not only is KOL the most commonly used term, but the largest percentage of respondents also reported that it is the most appropriate term."

Pharma Guy's insight:

LOL! Ask a carpenter what his/her most often used tool is and you are likely to hear "hammer." So should we be surprised that 62% of Medical Affairs pharma people respond that their companies use the term KOL?

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Targeted Drug Ads: Opening Pandora's Box

Targeted Drug Ads: Opening Pandora's Box | Pharmaguy's Insights Into Drug Industry News |

The drug industry spends billions each year to promote its medicines to the masses, blanketing popular TV shows and magazines with ads. Now, digital companies are increasingly trying to pry away a share of that money for ads that target specific patients, rather than broad demographics.


Targeted ads are nothing new in retail; anyone who uses the internet has had the eerie feeling that the ads popping up on page after page appear to be aimed directly at them. But drug makers have long steered clear of many such tools, for fear of violating patient privacy law.


That’s changing now. Facebook and the music streaming service Pandora are aggressively vying for pharma dollars by promising to help drug makers identify and reach the users most likely to have certain diseases or conditions — without violating the privacy law known as HIPAA.


Pandora is going hard after … pharma [drug ad] dollars.


Pandora now has more than 16 million individual monthly listeners over age 55 — and its fastest growing segments of new users are people in that bracket. Not surprisingly, over the past two years, the company has seen a rapid rise in interest from drug advertisers, according to Lee Ann Longinotti, who runs Pandora’s business with health care advertisers.


Pandora now counts 20 drug makers among its recent advertisers, including Pfizer, Merck, and Johnson & Johnson. They’ve promoted 40 different prescription and over-the-counter drugs, for conditions ranging from diabetes to erectile dysfunction to a circadian rhythm disorder common in the blind.


To target users more precisely, Pandora struck a partnership a year ago with Crossix, a company which mines anonymized patient data from electronic health records, insurance claims, and pharmacy transactions.


That’s allowed Pandora to create profiles of the types of people who are most likely to be interested in drugs for a certain condition. Then it helps the pharma company follow those users around as they listen to music on different devices throughout the day.


A mom who is a prime target for a given drug company, for instance, might hear ads for the same product as she listens to the Adele playlist on her computer at work, rocks out to the “Frozen” playlist with her kids in the car, and relaxes to jazz at home in the evening. Other listeners streaming the same general playlists at the same time would hear very different ads.


Further Reading:

Pharma Guy's insight:

People don't like it when they are followed around on the Web or digital devices and "targeted" by advertisers. The process often fails as when, in the past, HIV drugs ads were served up to people on the Web.

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@Richmeyer Rips Facebook a New One for Hosting Anti-Xarelto "Ambulance Chaser" Ads

@Richmeyer Rips Facebook a New One for Hosting Anti-Xarelto "Ambulance Chaser" Ads | Pharmaguy's Insights Into Drug Industry News |

According to the Times “If I were a Facebook executive, I might feel a Frankensteinian sense of unease these days. The company has been hit with a series of scandals that have bruised its image, enraged its critics and opened up the possibility that in its quest for global dominance, Facebook may have created something it can’t fully control.”  And they want pharma to advertise more?

As CEO of Facebook Mr. Zuckerberg’s modus operandi as a leader is to fix things long after they have broken , rather than to prevent problems in the first place.  For pharma that’s a major issue.

This is an ad that I keep seeing on Facebook as I was doing some research for a client.  I did an analysis of the comments and 85% were negative.  If I was a DTC manager or media buyer I would not proceed to give more money to the this monster.

Facebook has become some huge and profitable that they feel they can do no wrong.  They don’t have enough people with industry experience and their continued efforts to court pharma ad dollars is almost insulting.

Obviously Xarelto has risks, like any prescription drug, but hosting ads for ambulance chasers who profit off patient woes is is not a platform I would ever recommend to clients.

Pharma Guy's insight:

Still , this is less of a problem for me than hosting fake news ads/stories from Russian agents!

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J&J Was Alerted to Risk of Asbestos in Talc in ’70s, Files Show

J&J Was Alerted to Risk of Asbestos in Talc in ’70s, Files Show | Pharmaguy's Insights Into Drug Industry News |

Johnson & Johnson trained its employees to reassure anyone concerned about whether the company’s talcum powder contained asbestos that the cancer-causing substance “has never been found and it never will’’ in its iconic baby powder, according to an undated memo unsealed in a lawsuit against the drugmaker.


But plaintiffs say other unsealed documents indicate that J&J has known for decades that its talc products include asbestos fibers and that the exposure to those fibers can cause ovarian cancer. The talc used by J&J to make its products “is not now, nor has it ever been, free from asbestos and asbestiform fibers,’’ according to the lawsuit filed on behalf of more than 50 women in St. Louis.


The unsealed documents add another dimension to the claims against J&J as it defends itself from more than 5,000 suits across the U.S. blaming its baby powder products for causing women to develop ovarian cancer. While five juries have ruled against J&J, the company has won one case and had some other claims thrown out.



One of the documents unsealed Sept. 6 indicates that in May 1974, an official at J&J’s Windsor mine in Vermont recommended “the use of citric acid in the depression of chrysotile asbestos’’ from talc extracted from the site.


“The use of these systems is strongly urged by this writer to provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time,’’ the mine’s director of research and development wrote then.


Documents provided by J&J show tests of its talc stretching back to at least 1972 found no traces of asbestos, though the two minerals often occur naturally near each other. In a 1983 worldwide study of its talc products, the drugmaker found “all talcs in this report were found to be free from asbestiform minerals and to conform to cosmetic talc requirements.”


Further Reading:

  • “J&J Bites the Talc-powder Dust in Another Trial - Ordered to Pay $110 Million”;
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Opioids Are the New Tobacco: Investigations of #Pharma Companies Taking Page from Tobacco Settlement of the 90's

Opioids Are the New Tobacco: Investigations of #Pharma Companies Taking Page from Tobacco Settlement of the 90's | Pharmaguy's Insights Into Drug Industry News |

As investigations target major drug producers for their alleged roles in the nation's opioid abuse crisis, at least one expert says a 20-year-old settlement with tobacco companies could add perspective to the legal battles to come.


Starting in the mid-1990s, authorities in 46 states began filing lawsuits against major tobacco firms, arguing they knew their products were addictive and unsafe, and thus holding them responsible for health care costs incurred by the states to treat tobacco customers. Phillip Morris Inc., R.J. Reynolds, Brown and Williamson and Lorillard agreed to pay a minimum of $206 billion over the first 25 years of the agreement.


Scott Burris, professor of law and public health at Temple University’s Beasley School of Law, said 41 state attorneys general now investigating pharmaceutical companies and distributors and their role in the opioid abuse epidemic are essentially looking for evidence to support a similar argument: that opioid producers downplayed the dangers of their products.


“It makes sense, given plenty of evidence that (pharmaceutical) companies were marketing the hell out of these drugs, that it warrants an investigation,” Burris said.


Pennsylvania Attorney General Josh Shapiro told reporters Tuesday at Upper Dublin High School that the companies were being investigated to find any internal documents that might prove the companies knowingly misrepresented the addictiveness or danger of opioid painkillers.


“If they are infecting Pennsylvania with these poisons in an irresponsible, unethical or unlawful way, we’re going to hold them accountable,” Shapiro said.


Shapiro identified the companies currently under investigation as manufacturers Endo International, Janssen Pharmaceuticals, Teva Pharmaceutical Industries and its U.S. subsidiary, Cephalon Inc., Allergan Inc. and Purdue Pharma, as well as distributors AmerisourceBergen, Cardinal Health and McKesson.


Further Reading:

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House Committee Has "Concerns" About Cyberattack Against Merck

House Committee Has "Concerns" About Cyberattack Against Merck | Pharmaguy's Insights Into Drug Industry News |

Up to now, Merck has been reluctant to go into much detail regarding just how damaging a recent cyberattack has been to operations. Now, though, it’s going to have to as the House Committee on Energy and Commerce has raised the matter to an issue involving national security.

Merck has acknowledged that the attack on June 27 roiled its manufacturing, sales and R&D ops. Drug and vaccine manufacturing was crimped weeks after the attack and Merck conceded that it would hamper annual revenue as the company continued to scramble to repair the crippling aftereffects.

Ken Frazier, the CEO of Merck, at the White House on July 20, 2017, one month prior to resigning from the President’s manufacturing council afp photo / saul loeb
But the company has also been reluctant to spell out exactly how hard it was hit and where, leaving lawmakers looking to learn more about the impact and how a more effective cyberattack could wallop the entire healthcare sector.

The committee wrote:

"While there is no evidence, to date, that Merck’s manufacturing disruption has created a risk to patients, it certainly raises concerns. For example, in a recent update on national vaccine supply, the CDC reported that Merck would not be distributing certain formulations of the Hepatitis B vaccine. While it is unclear if this is related to the NotPetya disruption, and much of the supply can be filled by other manufacturers, it does raise questions about how the nation is prepared to address a significant disruption to critical medical supplies."

Lawmakers’ letter to Merck CEO Ken Frazier asks for a formal presentation detailing the cyberattack’s impact by October 4. The company says they’re in touch with the committee.

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Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data

Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News |

After a two-year battle, a pair of public health advocacy groups obtained sought-after clinical trial data from regulators for two hepatitis C treatments sold by Gilead Sciences. But they failed to gain access to the most coveted information that would allow researchers to independently verify test results which were originally generated by the company.


The Yale Global Health Justice Partnership and Treatment Action Group sought patient-level data in order to better understand the safety and effectiveness of the two medicines. But they encountered a familiar argument from the company — as well as the Food and Drug Administration — that revealing such raw data may compromise trade secrets and patient confidentiality.


The FDA redacted certain data, “which would permit analysis, including validating the results that were reported by the company,” Dr. Joseph Ross, an associate professor at the Yale School of Medicine, who worked with the groups, wrote us.


The effort began nearly three years ago when the groups asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. As we wrote at the time, they sought this data because the medicines have been widely prescribed, thanks to high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.


Gilead, however, balked at releasing any data, so the groups then turned to the FDA, since the company had filed all sorts of clinical trial information with the agency in order to win regulatory approval to sell the drugs. But the agency indicated the Freedom of Information request would take up to two years to fulfill, so in June 2015, groups filed a lawsuit to force the FDA to cough up the data.


The advocacy groups argued in their lawsuit that doctors “lack(ed) the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups contended it is “crucial that policymakers be able to evaluate the cost-effectiveness … based on the underlying clinical data. …” The list prices for the drugs were $84,000 and $94,500 for 12-week regimens, before rebates.


Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”;
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”;
Pharma Guy's insight:

I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. There were reported relapses occurring in short clinical trials, so I would expect even more relapses in the real world long-term.

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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