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Pharmacists Say DTC Advertising Must Go: It's "Not Working" & Wastes Resources

Pharmacists Say DTC Advertising Must Go: It's "Not Working" & Wastes Resources | Pharmaguy's Insights Into Drug Industry News |

This week a national pharmacist group, the American Society of Health-System Pharmacists, joined the physicians of the American Medical Association in a call to ban DTC ads (see here).


ASHP had been provisionally tolerant of DTC ads--that is, it was unopposed as long as the advertising met certain prerequisites. It had to be educational, using easy to understand language for benefits and risks; include directions for adverse event reporting; and promote safety and allow informed decisions.


It became clear to the group that those standards were largely being ignored by pharma companies, said Kasey Thompson, chief operating officer and senior VP of ASHP’s office of policy, planning and communications. So ASHP revoked its provisional support.


“There is no question that patient education is important--even some patient education provided by the pharmaceutical industry,” he told FiercePharmaMarketing, adding that, “[A]t the end of the day, a complete ban isn't achievable--we all know the arguments about first amendment rights and free speech--but I think what our delegates are trying to achieve here is to force a conversation between the industry and the healthcare provider community.”


Physicians and pharmacists spend too much time having to explain TV ad drugs that aren’t appropriate for patients, he said, and overall “the model out now for DTC isn’t working.” He said the ASHP's move, along with the AMA’s decision, are signals from the healthcare community that it’s time for a change.


“Pharma does great things in terms of innovation, and we need this industry. It’s not trying to limit innovation and R&D. It’s about utilizing scarce resources in the most effective ways possible and we think, as the AMA thinks, that direct-to-consumer advertising is not an optimal use of resources," Thompson said. "There must be a better way for smart well-intentioned people that are focused on the patient can arrive at."

Pharma Guy's insight:

The comments from the ASHP regarding the failure of DTC advertising & its tepid nod to pharma's patient educational efforts come soon after the industry's DTC "creative" ad agencies patted itself on the back at the Cannes Lion Health Festival (more on that here:

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DEA Approves FDA-Approved Insys Synthetic Marijuana

DEA Approves FDA-Approved Insys Synthetic Marijuana | Pharmaguy's Insights Into Drug Industry News |

Insys Therapeutics, a pharmaceutical company that was one of the chief financial backers of the opposition to marijuana legalization in Arizona last year received preliminary approval from the Drug Enforcement Administration this week for Syndros, a synthetic marijuana drug.


Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona year (read “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”; The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization. Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.


Syndros is a synthetic formulation of THC, the main psychoactive component in the cannabis plant. It was approved by the FDA last summer to treat nausea, vomiting and weight loss in cancer and AIDS patients. The DEA approval places Syndros and its generic formulations in Schedule II of the Controlled Substances Act, indicating a "high potential for abuse." Other Schedule II drugs include cocaine, morphine and many prescription painkillers.


"It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets," a spokesman for Arizona's marijuana legalization campaign said of Insys last year.


Insys is also the subject of numerous state and federal criminal investigations, as well as a shareholder lawsuit, over its aggressive marketing of a product containing the potent and deadly opioid painkiller fentanyl. In December, the FBI arrested the company's former chief executive and five other executives on charges that they "paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression." [See]


In addition to its synthetic marijuana products, Insys is also developing a drug to treat opioid overdose.

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Vascepa: Amarin's Yellow Brick Road to the American Heart Association

Vascepa: Amarin's Yellow Brick Road to the American Heart Association | Pharmaguy's Insights Into Drug Industry News |


A decision by the American Heart Association to invite the Amarin chief executive to chair its annual gala, which will have a “Wizard of Oz” theme, is causing a flap worthy of the Wicked Witch.


Why? Amarin itself is controversial for the aggressive approach it’s taken toward promoting its prescription fish oil pill for lowering high triglycerides levels. The company filed a lawsuit two years ago against the Food and Drug Administration after the agency rejected its bid to market the pill for people with slightly lower levels, which is an unapproved use (read “Amarin Wins Off-Label Case Against FDA; Vows to Promote Viscera Off Label "’ASAP’";


The lawsuit caused a sensation amid mounting pharmaceutical industry complaints that the FDA squelches free speech (read “FDA May Soon Be Replaced by Judicial Off-Label Activism”; The agency subsequently settled the case, allowing Amarin to promote its Vascepa pill for this unapproved use to physicians. But some believe that, by tapping Amarin’s John Thero, the AHA appears to be unwisely endorsing the company’s tactics and its drug.


Dr. Harlan Krumholz, a Yale University cardiologist, tweeted:


“One wonders if American Heart Assoc might have been able find chair for their ball w/less baggage an effective evidence-based med.”


Meanwhile, in a March 21 press release announcing the gala, AHA senior vice president Kathy Kauffman gushed that Amarin and its CEO “bring passion and great leadership to the Heart & Stroke Ball.” Moreover, the press release was jointly released by the drug maker and the AHA, a move that an AHA spokesperson admitted was a mistake in comments to CardioBrief, which first reported about the gala.


In fact, as CardioBrief pointed out, Amarin contributed $60,000 to the AHA during its 2016 fiscal year, although in fairness, the drug maker was one of approximately 50 companies that donated more than $29 million to the organization. One patient advocate suggested the praise in the news release and the corporate contribution gave the impression of an improper relationship.


So what does the AHA have to say for itself? More…


Further Reading:

Pharma Guy's insight:

File this under “If they only had a brain.”

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Coalition of Unidentified Health Industry “Stakeholders” Won’t Sit By & Watch Critical NIH-Funded Research Be Stifled – LOL!

Coalition of Unidentified Health Industry “Stakeholders” Won’t Sit By & Watch Critical NIH-Funded Research Be Stifled – LOL! | Pharmaguy's Insights Into Drug Industry News |

During his budget blueprint announced earlier this month, President Donald Trump announced swingeing (sic) cutbacks across federal programs, with the National Institutes of Health (NIH) set for a $5.8 billion slashing (read “Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!”;


The blowback for Trump was however immediate, with UsAgainstAlzheimer’s, ASCO, J. Craig Venter, executive chair and founder of biotech Human Longevity, and, more moderately, BIO, all raising their concerns about what the cuts will mean for research.


Now, a new coalition has come out of the criticism to help preserve federal funding levels for the NIH, which were around $31 billion last year. Details were thin, but ‘The Coalition to Save NIH Funding’ is said in a release to be made of: “Stakeholders in healthcare, research, pharmaceutical development, patient advocacy and other non-profit organizations.”


Exactly who these are have not been made public as yet, with the PR posted by health campaign firm JPA Health Communications. The members will however be the ones to set the agenda and priorities for the Coalition.


“While JPA will be coordinating the traditional materials (i.e., position papers, media engagement), our efforts are focused on helping people understand why research is important, why and how patients benefit from it, and why the cuts will be devastating in state and local districts. What develops from basic research touches each and every one of us. We must protect it.”


“We were dismayed to learn that the NIH is vulnerable to deep funding cuts,” said Carrie Jones, principal of D.C.-based JPA. “Each day America benefits from the innovation and scientific discoveries made at the NIH. We won't sit idly by and watch critical research be stifled.”


Further Reading:

  • “PhRMA Lacks the Guts to ‘Go Boldly’ & Speak Out Against Trump’s Proposed Cuts to NIH Funding”;
Pharma Guy's insight:

Who are these bozos? Don't they know that their protest is worthless if they do not identify themselves! More cowards!

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Physicians Tackle Climate’s Health Effects

Physicians Tackle Climate’s Health Effects | Pharmaguy's Insights Into Drug Industry News |

According to several recent surveys, the majority of practicing physicians recognize that climate change is happening, believe it is at least in part caused by humans, and already see it affecting their patients, said Mona Sarfaty, MD, MPH, director of the program on climate and health at George Mason University’s Center for Climate Change Communication in Fairfax, Virginia.


Sarfaty coauthored the surveys, in which members of the National Medical Association, the American Thoracic Society, and the American Academy of Allergy, Asthma, and Immunology participated. Many physicians said they believed they had a responsibility to inform the public and their patients on climate-related health effects but wanted to be better informed.


These findings led Sarfaty and her colleagues to form a consortium of medical societies. Last November the Medical Society Consortium on Climate and Health, now consisting of 12 medical societies that represent almost half of US physicians, launched its website with a mission to inform physicians, the public, and policy makers about the harmful effects of climate change and various ways to find solutions.


Linda Rudolph, MD, MPH, director of the Center for Climate Change and Health at the Public Health Institute in Oakland, California, also has surveyed physicians and public health professionals about climate change and health. Many said they’re reluctant to speak out because they lack expertise, while some also felt they don’t have the time, mandate, funding, or resources to address it. The politicization of the issue also has influenced some to avoid it.


Rudolph and her colleagues have been working in California to introduce physicians to the array of potential roles that medical providers can play in issues of climate change and health. For example, they can integrate climate change into patient education, management, and care protocols; speak to their communities and peers; or work to help green their organizations and institutions. The Center for Climate Change and Health created A Physician’s Guide to Climate Change, Health, and Equity, which pulls together a wide range of information on the topic.


“We’re also trying to identify individuals who want to become advocates, champions on climate and health,” said Rudolph. Although the majority of people in the United States now think global climate change is happening, many remain unaware of the immediate threats climate change poses. But Rudolph and others have noted that as trusted messengers, physicians can play an important role in informing their patients, their community, and policy makers.


She said her group has helped some physicians speak on Spanish-language radio programs in Stockton, California, introducing the general subject of climate change and health and then presenting a more specific segment on climate change and mental health.


The Center for Climate Change and Health also hosts the US Climate and Health Alliance, a national network of individuals and medical and health organizations. Through the alliance, Rudolph and her colleagues have identified groups who see climate change and health as a critical issue and are taking action in their local communities.

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Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers

Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers | Pharmaguy's Insights Into Drug Industry News |

If you needed more evidence as to why drugmakers continue to plunge billions of dollars into direct-to-consumer advertising, look no further than a recent study published in JAMA. In it, researchers found that broadcast DTC ads for drugs treating low testosterone were linked with “substantial overall increases” in patients being tested and treated for the same condition.


Researchers at the University of North Carolina at Chapel Hill investigated this potential link in 75 areas across the U.S. They found that out of 17 million commercially insured men, one million were tested and just over 283,000 began treatment between 2009 and 2013.


“Although the average increase in testosterone rates associated with a single ad exposure was less than 1%, advertisements were widespread and and frequent during the study period, direct-to-consumer advertising was associated with substantial overall increases in testosterone testing and initiation,” the study's' authors wrote.


[Note: The authors also wrote:


“While other studies have demonstrated associations between DTCA and increasing medication use, this study demonstrates increases in potentially inappropriate use and increasing initiation during a time when most testosterone use was of questionable value for age-related testosterone decreases without strong evidence of benefit. Characterizing the role of DTCA in promoting testosterone initiation among a large segment of middle-aged and older men for nonspecific symptoms and age-related declines in testosterone levels is relevant to ongoing policy debates regarding DTCA. This study complements many others that suggest the contribution that DTCA may make in the early adoption of recently approved treatments whose risk-benefit profile may be quite unclear.”


Consider the implications if drug marketers were allowed to promote off-label uses to consumers. In those cases the risk-benefit profile is certainly unclear or unverified by the FDA.]


Further Reading:



The Marketing of Low T.” Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut discusses how the marketing of Androgel uses ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated.

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Pharma’s Rep Among Patient Groups Sinks to Near Historical Lows

Pharma’s Rep Among Patient Groups Sinks to Near Historical Lows | Pharmaguy's Insights Into Drug Industry News |

For all the criticism that drug makers have endured in recent years, a new survey finds that they are faring worse than ever. Just 38 percent of patient groups thought the pharmaceutical industry had an “excellent” or “good” reputation last year, down from almost 45 percent in 2015 (read “Pharma's Rep Among Patient Groups at 4-Year High”;, according to PatientView, a research firm that canvassed more than 1,400 patient groups from 105 countries.


Not surprisingly, the pharmaceutical industry fares poorest when it comes to pricing.


Just 11 percent believe drug makers offer fair pricing, down from 15 percent two years ago and the lowest-ever ranking since the firm began this annual exercise in 2011. It is also worth noting that the measly 15 percent showing in 2015 was the best report card on pricing that the industry received over the past six years. In other words, patient groups have been especially unhappy about drug prices.


The patient groups were asked to assess 47 drug makers on seven traits: the extent to which the companies are focused on patients; the sort of information provided patients; patient safety; useful products; transparency; integrity, and the effectiveness of the relationships with drug makers.


For instance, 59 percent of patient groups said that drug companies were innovative, a notable drop from 69 percent in 2015 and the lowest showing since 2011. Similarly, 64 percent reported the industry makes “high quality, useful products,” down from 72 percent last year and barely exceeding the 63 percent lowest rating in 2012, which was the low point.


Further Reading:

  • Can You Trust Patient Rankings of #Pharma Corporate Reputation?; 
  • Americans Hate the #Pharma Industry Almost as Much as They Hate U.S. Gov't!; 
  • Italian edition: Corporate Reputation of Pharma in 2015 - the views of 67 Italian patient groups; 
  • 83% of Patient-Advocacy Organizations Receive Substantial Financial Support from the Drug Industry But Few Disclose How Much;

Pharma Guy's insight:

I've said that you can't trust the opinion of patient groups about the pharma industry - 88% receive money from the industry. I can't explain why all the charts dipped so dramatically in 2016 compared to 2015. There was plenty of bad press in 2015 and prior years. This survey was conducted from November 2016 to early-February 2017. Maybe it's a "Trump effect"? Or perhaps the drug industry "cut back" on the funds paid to these groups? - I read that somewhere - just 'kiddin' - I completely made that up. What? Didn't you see the air quotes?

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Trump Versus Big Pharma: “Somebody’s Getting Very Rich”; i.e., "Getting Away with Murder"

Trump Versus Big Pharma: “Somebody’s Getting Very Rich”; i.e., "Getting Away with Murder" | Pharmaguy's Insights Into Drug Industry News |

On Monday night, President Trump rallied a crowd in Louisville, Kentucy by repeating a populist pledge to roll back drug prices. And he added that his administration was working to add pricing legislation to the current healthcare bill, or one coming up “right after.”


Once healthcare reform is done and Obamacare has been repealed, he told the crowd, it will be time to get to work on medicine, “bringing down the cost of medicine by having a fair and competitive bidding process. Some people think that’s just as important as healthcare.”


“The cost of medicine in this country is outrageous, many times higher than in some countries in Europe and elsewhere. Why?”


“Same pill, same manufacturer, identical and it’s many times higher in the United States.”


“You know why? Campaign contributions. Who knows. But somebody’s getting very rich.”


Further Reading:

Pharma Guy's insight:

First Trump accuses the drug industry of "getting away with murder" (  then he says "somebody's getting very rich." Sounds like he's describing himself!

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Ken Griffey Sr. is a Spokesman for Bayer's Men Who Speak Up Prostate Cancer Awareness program

Ken Griffey Sr. is an advocate for cancer screening and a spokesman for Bayer’s Men Who Speak Up campaign.


As part of Bayer's Baseball All-Star and prostate cancer survivor Ken Griffey Sr. and Dr. Neal Shore, Medical Director of the Carolina Urologic Research Center, discuss the importance of speaking up about advanced prostate cancer and the symptoms men may experience.


See the Gallery of Drug Advertising Celebrities for other pharma spokespeople.

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PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding

PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding | Pharmaguy's Insights Into Drug Industry News |

The National Institutes of Health is staring down a proposed $6 billion budget cut that could slash funding for biomedical research. The response from the drug industry’s largest lobbying group?


Let’s call it tepid.


“As we review the president’s budget proposal, we look forward to continuing to work with President Trump and Congress to improve American competitiveness and protect American jobs,” PhRMA spokeswoman Nicole Longo said in a statement. She added that the organization remains “committed to ensuring that policies support innovation and value to deliver this new era of medicines to patients.”


Biotech — to the extent it can be surveyed on Twitter — was not impressed.


“Those people are truly useless,” opined Michael Gilman, a serial entrepreneur now leading Arrakis Therapeutics.


“This is pathetic,” added John LaMattina, former head of R&D at Pfizer. “The new PhRMA head continues to be unimpressive.”


“Too bad PhRMA cannot muster the guts necessary to speak out,” tweeted Dr. Samuel Blackman, an oncologist and cancer researcher.


PhRMA’s bland response comes in stark contrast to statements from the Bill and Melinda Gates Foundation and the American Society of Clinical Oncology, which contained terms like “deeply troubled” and “devastate our nation’s research infrastructure.”


Further Reading:

Pharma Guy's insight:

I called PhRMA cowards. They certainly aren't going "boldly" into the dying of the light.

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Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!

Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive! | Pharmaguy's Insights Into Drug Industry News |

The National Institutes of Health would absorb an enormous $5.8 billion cut under President Trump’s first budget proposal — equal to about 19 percent of its current $30.3 billion discretionary budget.

The plan “includes a major reorganization” of NIH’s 27 institutes and centers and would eliminate the Fogarty International Center, a $69.1 million program dedicated to building partnerships between health research institutions in the United States and abroad.

With few details available in the budget outline, it is unclear what kind of reorganization the administration envisions at NIH, the crown jewel of U.S. biomedical research. The agency funds research into a vast array of diseases and conditions, including cancer, heart disease, developmental disorders and mental illness.

The agency passes out more than 80 percent of its money to more than 300,000 researchers at universities across the country and abroad. It also has hundreds of researchers conducting studies in labs at its sprawling campus in Bethesda, Md. Its world-renowned clinical center treats patients from around the world seeking last-chance cures and volunteers testing cutting-edge therapies.

Pharma Guy's insight:

This is part and parcel of the current anti-science sentiment and a good reason for pharma people to participate in the April 22 March for Science: 

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Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys | Pharmaguy's Insights Into Drug Industry News |

Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.


Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.


“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.


Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”


In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.


Further Reading:

Pharma Guy's insight:

Seniors have bee avoiding getting vaccinated for shingles even though the Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60 (read “Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine”; Perhaps the side effects mentioned in this article is a bigger reason.

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Pharma Showers West Virginia with Oxycontin: 433 Pills for Every Man, Woman, & Child!

Pharma Showers West Virginia with Oxycontin: 433 Pills for Every Man, Woman, & Child! | Pharmaguy's Insights Into Drug Industry News |

In a town hall televised by MSNBC Monday night, Sen. Bernie Sanders called out the pharmaceutical industry for pumping addictive opioids into small, rural towns—parts of the country already devastated by disappearing jobs and crumbling infrastructure.


“I’ve got to tell you, I’m not a great fan of the pharmaceutical industry in general,” Sanders said, according to the Bluefield Daily Telegraph. “For them to make to make billions in profits by getting young people addicted and ruining their lives … we have to start holding them accountable.”


The event was held in McDowell County, West Virginia, which has one of the highest per capita fatal drug overdose rates in the country. Not by coincidence, West Virginia coal country was the target of a concerted push by the pharmaceutical industry to bring addictive painkillers to poor, rural regions.


In December, the Charleston Gazette-Mail reported that out-of-state pharmaceutical companies went to extreme lengths to sell drugs in West Virginia, including McDowell County. In one case, just one pharmacy in a town of 392 received 9 million hydrocodone pills over the course of two years.


“In six years, drug wholesalers showered the state with 780 million hydrocodone and oxycodone pills, while 1,728 West Virginians fatally overdosed on those two painkillers,” the investigation found. “The unfettered shipments amount to 433 pain pills for every man, woman and child in West Virginia.”


Further Reading:

  • “Secret Internal Sales Documents Reveal Abbott's Despicable "Crusade" to Sell OxyContin” in West Virginia:
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Glaxo to Pay First Woman CEO Less, Cites Lack of Experience

Glaxo to Pay First Woman CEO Less, Cites Lack of Experience | Pharmaguy's Insights Into Drug Industry News |

Emma Walmsley, poised to take over as the first female chief executive officer of GlaxoSmithKline Plc, will earn about a quarter less than her predecessor Andrew Witty to reflect her lack of experience at the helm.


Walmsley will be paid an annual base salary of about 1 million pounds ($1.2 million), the London-based drugmaker said in its annual report. That compares to Witty’s pay of 1.15 million pounds last year. Her targeted bonus doesn’t exceed her salary, whereas Witty was given the opportunity to collect 125 percent of his pay through the bonus.


The lower compensation, for a woman who is breaking the gender barrier to become the first female to manage one of the world’s top 25 pharmaceutical companies, is likely to re-ignite a debate on the pay gap between the sexes. But it isn’t unusual that compensation levels change when a new CEO takes office as boards seek to link pay packages to the person’s level of experience and tenure.


“This is the moment to reassess the executive pay structure,” said Stefan Stern, director of the High Pay Centre, a think tank on top U.K. executive remuneration. “It’s good to focus on the contribution from the new person and it’s good to be tough and pay somebody less than their predecessor if their CV is at a different stage.”


Further Reading:

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Trumpcare is a Disaster in the Making!

Trumpcare is a Disaster in the Making! | Pharmaguy's Insights Into Drug Industry News |

The Congressional Budget Office released its much-anticipated report on the stakes of the American Health Care Act. Here's your rundown of the projected impact:


  • An estimated 14 million Americans would lose insurance by 2018-19 under the new plan.
  • By 2026, 24 million more would be uninsured after significant changes to Medicaid. That would drive the total number of Americans expected to be living without health insurance up to 52 million by 2026, compared to 28 million under Obamacare. 
  • Federal spending in Medicaid would fall by $880 billion by 2026, with a projected 14 million fewer people enrolled in the program than if Obamacare stayed in place.
  • Cuts to federal Planned Parenthood funding would mean 15 percent of people who “would probably reside in areas without other health care clinics or medical practitioners would lose access to care." 
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AstraZeneca Scrapes the Bottom of the Rejected Drug Barrel for "New Drugs" - Innovation Redefined

AstraZeneca Scrapes the Bottom of the Rejected Drug Barrel for "New Drugs" - Innovation Redefined | Pharmaguy's Insights Into Drug Industry News |

AstraZeneca is working with outside researchers to look for untapped potential in drugs that the company has shelved, part of a broader move to improve its research-and-development output.

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The End is Nigh for Crooked Valeant: Ackman Dumps Shares & Leaves

The End is Nigh for Crooked Valeant: Ackman Dumps Shares & Leaves | Pharmaguy's Insights Into Drug Industry News |

Bill Ackman has finally conceded defeat on Valeant Pharmaceuticals International Inc.


After waging a costly and outspoken public defense of the controversial drugmaker, its once-biggest champion sold his entire stake in the company at a loss and said he will leave the board.


Precise figures are hard to come by, but public filings suggest that Ackman’s Pershing Square Capital Management may have lost $2.8 billion just on the Valeant shares it owned at the end of 2016, with overall losses likely to be much higher. The shares have plunged more than 90 percent from their peak.


Billionaire Ackman’s big, concentrated bets and brash personality have made him one of the most polarizing names in investing. His decision to give up on Valeant, a favorite among hedge-fund types before probes into its business practices (read “Former Crooked Valeant Executive and Philidor CEO Charged with Fraud”;, accounting and drug pricing (read “Four Companies - Including Criminal Valeant - Raked Over the Coals for Staggering Price Hikes by Senate Report”; caused a collapse in the shares, comes after a lengthy campaign to turn around the company and salvage his investment.


The sale ends a near three-year saga that first saw Ackman team up with Valeant in a hostile bid for a rival, before later making a direct investment. Over the same period regulators intensified scrutiny of the drugmaker, its management and the board were overhauled, and its value was decimated.


  • Further Reading:
  • “More Top Executives Flee Sinking Crooked Valeant Ship”;
  • “LOL! Crooked Valeant May Change Its Name But Will Still Smell Bad to Investors!”;
  • “Not Only is Valeant a Criminal Organization, It is Also Incompetent at Marketing, Say Investors”;
  • “Crooked Valeant #Pharma Guilty of Deceptive Practices Says T. Rowe Price”;


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Over Half of the DTC Ad Spend by the Top 10 Advertised Drugs in 2016 was Made by Pfizer

Over Half of the DTC Ad Spend by the Top 10 Advertised Drugs in 2016 was Made by Pfizer | Pharmaguy's Insights Into Drug Industry News |

Pharma companies’ ad spending jumped again last year to $5.6 billion, up from $5.2 billion in 2015, according to Nielsen data (read “Direct-to-Consumer #Pharma Drug Ad Spending at an All-Time High”; And Pfizer is in large part to thank.


The drugmaker led the top branded spending for Lyrica, with $174 million on fibromyalgia ads and another $170 million advertising its indication for diabetes-related pain, for a total of $344 million. Lyrica was trailed by another Pfizer drug, rheumatoid arthritis-fighter Xeljanz, at $189 million, and Eli Lilly’s diabetes treatment Trulicity, with $185 million spent. And Pfizer didn't stop there; five of the top nine meds with the highest spending are Pfizer brands.

Pharma Guy's insight:

The total spending of the TOP 10 drugs in 2016 was $1.59 billion. At least $880 million of that (55%) was spent by Pfizer.

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#FierceMadness Features Some Scary DTC Ads: Dis These Duds!

#FierceMadness Features Some Scary DTC Ads: Dis These Duds! | Pharmaguy's Insights Into Drug Industry News |

#FierceMadness is back—this time with DTC advertising. We've [FiercePharma] created our first-ever DTC March Madness tournament where drugmakers and their brands square off in search of the national title for best pharma ad of 2016.


Get ready for a battle. Pharma advertising can be polarizing, to say the least. For every ad watcher who wanted a Xifaxan "Gut Guy" squishy ball, five others were grossed out by the walking, talking intestinal tract that consistently interrupted their Sunday afternoon football. For every person who switched channels when the ladies in blue dresses started talking about erectile dysfunction, there were men who tuned in to the messages for info about Viagra single packs and text-in discount coupons.


But what is it that makes a "good" pharma ad? Is it edgy creative or serious messaging? Scary warnings or humorous characters?


In the spirit of March Madness basketball-bracket mania, we’d like our readers to help us figure that out. We've set up a Fierce bracket of matchups with ads that ran in 2016, and we want you to vote for your favorites and tell us why. For each round, cheer the champs and dis the duds in the comments section on the poll form.


To get started, the FiercePharmaMarketing staff has selected 40 of the best, most interesting or most controversial DTC advertising campaigns from 2016.


Some duds that should be dissed include:


Ad: “Flooded Room” heart failure disease awareness. Brand: Entresto. Further reading:


Ad: Entresto “Tomorrow”. Further reading:

  • “DTC Didn't Work, So Novartis Bumps Up Entresto Physician Marketing by $200M”;


Ad: Opdivo “Most prescribed immunotherapy”. Further reading:

  • “Opdivo TV Ads "Educate" Patients About the Positive, Not the Negative Trial Data”;


Ad: “Ready. Raise. Rise” immuno-oncology awareness. Further reading:

  • “Ads for ‘Breakthrough’ Cancer Drugs Are ‘An Ocean of Hype,’ Say Oncologists”;


Ad: “PBA Facts” disease awareness with Danny Glover. Further reading:

  • “25% More People Think They Have PBA After Seeing Danny Glover Laughing Uncontrollably!”;


Ad: “Big Bad Wolf” whooping cough vaccination. Further reading:

Pharma Guy's insight:

I hate advertising awards because they are so self-centered and only serve to promote advertisements for ad agencies in the publications that sponsor them. In this case, I pick out some of the worst ads that I think deserve no respect :)

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Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.?

Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.? | Pharmaguy's Insights Into Drug Industry News |

President Donald Trump has pledged to reverse what he describes as "astronomical" drug prices in the U.S. Thousands of miles away, Japan, long a profit sanctuary for multinational pharmaceutical companies, is taking a similar tack.


About $93 billion is spent annually on medications in Japan, and the government plays a key role on prices because it covers about 40 percent of the country’s health spending via its national insurance scheme. In December, officials announced plans to review drug prices more frequently: annually for all therapies and quarterly for the newest and most expensive ones that are used widely.


In November, the government unexpectedly decided to slash the price of Opdivo by half to 75,100 yen ($660) for 20 mg bottles after an oncologist estimated that it could cost the national health system $15 billion annually. That forced Ono, the company that co-developed the drug with Bristol-Myers and sells it in Japan, to lower its profit outlook for the current fiscal year by 25 percent.


Despite the protests, the Japanese pressures are nowhere near done for pharma. The government is already preparing to assess the price levels of seven drugs for the next round next year. Gilead’s Sovaldi and Ono and Bristol-Myers Opdivo are among the drugs selected for another round of reviews and could potentially face even more reductions. Gilead declined to comment.


The government will push for tighter cost control going forward, said Atsushi Seki, a Tokyo-based pharma analyst at UBS Group AG. “It will also put more pressure on drug prices as drugmakers seek combination therapies of expensive medicines.’’

Pharma Guy's insight:

Not if Gottlieb - who is on BMS's board - is approved as FDA Commish!

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Biopharma execs give Scott Gottlieb’s nomination for FDA commish (almost) a standing O in Endpoints poll

Biopharma execs give Scott Gottlieb’s nomination for FDA commish (almost) a standing O in Endpoints poll | Pharmaguy's Insights Into Drug Industry News |

A big majority of biopharma executives overall are clearly enthusiastic about President Trump’s decision to nominate Scott Gottlieb as the next FDA commissioner.

In our snap poll over the weekend Gottlieb picked up 87% support among the 580 qualified subscribers who voted on the decision, with 504 approving the choice against 76 who largely hated it.


[Public Citizen, however, said “[Gottlieb] Has Extensive Industry Ties and Dangerous Deregulatory Ideas”.]


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The Big Pharma/Big Media Collusion Conspiracy Theory

The Big Pharma/Big Media Collusion Conspiracy Theory | Pharmaguy's Insights Into Drug Industry News |

When you tune in to MSNBC, Fox News, or any of the other corporate media machines, you’re probably not going to hear much about the methods in which big pharma is taking advantage of consumers either through price gouging or medical mishaps. The reason for this is because talking about those stories creates a major conflict of interest for the people behind the scenes. Mike Papantonio discusses this with journalist and author Martha Rosenberg.


According to a 2009 study by Fairness and Accuracy in Reporting, with the exception of CBS every major media outlet in the United States shares at least one board member with at least one drug company. Let me put it in perspective for you, these board members wake up, they go to a meeting at Merck or Pfizer, and then they have their driver take them over to a meeting with NBC to decide what kind of programming that network is going to air. For those board members who aren’t pulling double duty with a media conglomerate and a big drug company, they still understand that they can’t be honest and objective about big pharma because big pharma pays their bills.


Drug companies spend about $5 billion a year on advertising with these corporate media outlets, so when Pfizer or Merck or Eli Lilly, or any of the drug companies, kill or cripple Americans with defective drugs, do you really think these board members are going to allow their story to be told on the air? It can take anywhere from three days to a full week before the media reports on a drug or a medical device recall, if they report at all.


In the case of Invokana it took 32 days before television outlets reported a single story involving an FDA warning about the potential problems with the product. The FDA began warning about the extreme dangers of Cook IVC filters as early as 2010 and it took about five years, five years, before television media started reporting that to the public. It’s worth pointing out that in these instances it was only through non-corporate independent media outlets that these stories were told at all. It was the outlets who weren’t being forced, they weren’t being forced to remain silent about the drug industry.


Drugs are cash cow advertising bonanza for corporate media. Fortunately an increase in number of Americans who are starting to wake up and realize that the mainstream media shouldn’t be trusted on issues like this. In recent years we’ve seen the alternative media experience rapid growth and mainstream media has been losing credibility at a staggering rate. Americans are starting to look elsewhere for the truth about what’s really going on out there. As a result of that advertising money kicking around the corporate media isn’t permitted to report complex drug stories anymore.


It’s as if they don’t understand things like the link between crony capitalism and the revolving door between the FDA and the drug industry, but the media is only one side of the story here. Big pharma knows that if it wants to continue manipulating the public it has to start with our elected officials in Washington DC. According to OpenSecrets, big pharma spent more than $58 million on politicians just in 2016, the most amount they’ve spend on a direct contribution in the last quarter century.


When it comes to lobbying, few industry spend more than big pharma did last year. They spent a staggering $244 million dollars to influence our elected leaders in Washington DC. It looks like things are about to get much worse, you see, big pharma understands that the ridiculous … their price gouging is starting to draw negative attention from the American public, and no matter how much they spend advertising or buying our politicians, they can’t keep the public anger down forever.


According to a new report by ProPublica, drug companies are offering huge money to any scientist, any professor or academic willing to author studies that are going to show that these drug markups are necessary, that they’re just fine. Their goal is to spread around enough money at universities to develop scientists and doctors who are going to create this fantasy story about how price gouging is just great for the American public, and then that story will be run by corporate media, dominated by the drug industry.


Further Reading:

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Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux

Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices Redux | Pharmaguy's Insights Into Drug Industry News |

Len Schleifer made something of a splash at an industry conference last December. The Regeneron Pharmaceuticals chief executive chastised Pfizer chief executive Ian Read over drug prices while participating in a panel discussion (read “Oh Snap! Regeneron CEO Says What to Pfizer CEO Ian Read???”;


Ed Silverman of Pharmalot recently spoke with him about drug pricing and the FDA, too. This is an excerpt.


Pharmalot: You made a point that companies shouldn’t be doing things like taking more than one price hike a year or a certain percentage. But what, if any, commitment has your company made or is willing to make?


Schleifer: I’m not convinced that the reason people are so angry is because there’s been a few bad actors. In fact, a few bad actors are not the problem. The problem is the public doesn’t feel like they’re getting something they can afford. It’s not a surprise that the populist movements of both Democratic and Republican parties are pointing fingers at the pharma industry as being greedy and unreasonable.


Pharmalot: But no one prompted you to say what you did to Ian Read. Why were you so openly vocal?


Schleifer: I argued with Ian for good reason. He said two things which I violently disagree with. One is that he said he prices his drugs to the value that they deliver. And I take great exception to that because I said I don’t understand how you can actually say that. Because if you really believe that, then why would the prices of some of those drugs go up 10 or 15 percent sometimes twice a year?


Has the value delivered gone up? I didn’t like people running around representing our industry and saying one thing and doing another.


Second thing is he wanted to make the argument that the percentage of GDP that drugs cost hasn’t changed very much. That may be true and may be a good thing. But I told him nobody out there is allocating a certain fraction of the GDP for the drug industry. We have to justify that fraction.


I’ve also taken issue with the so-called social contract. [Allergan chief executive Brent Saunders recently committed to keep price hikes for most drugs at below single-digit increases and a couple of other companies have followed suit. Read “Allergan's Brent Sauders' Manifesto on Drug Prices & Access”;]. They talk about no more double-digit price hikes and then they came out with 9 point something percent. That doesn’t sound to me like something like a real bargain.


But if you step back and understand why people have chosen price hikes. It’s fairly obvious — because they could. It’s a hell of a lot easier to generate growth by raising prices, because if you can raise prices by 10 percent, it’s a risk-free way of generating billions of dollars in revenue as opposed to actually having to discover new drugs, which is incredibly hard.


Pharmalot: Okay, so you’ve framed the problem, but what do you think are the solutions?




Further Reading:

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Because of Potential Abuse, Orphan Drug Act Might Need to Be “Repealed & Replaced”

Because of Potential Abuse, Orphan Drug Act Might Need to Be “Repealed & Replaced” | Pharmaguy's Insights Into Drug Industry News |

Building on weeks of mounting pressure to address high prescription drug prices, three influential U.S. senators have asked the government's accountability arm to investigate potential abuses of the Orphan Drug Act.


In a letter to the U.S. Government Accountability Office, Sens. Orrin Hatch, R-Utah, Chuck Grassley, R-Iowa, and Tom Cotton, R-Ark., raised the possibility that regulatory or legislative changes might be needed "to preserve the intent of this vital law" that gives drug makers lucrative incentives to develop drugs for rare diseases.


"While few will argue against the importance of the development of these drugs, several recent press reports suggest that some pharmaceutical manufacturers might be taking advantage of the multiple designation allowance in the orphan drug approval process," the letter published Friday states.


In January, NPR published a Kaiser Health News investigation that found the orphan drug program is being manipulated by drug makers to maximize profits and to protect niche markets for medicines being taken by millions (read “Orphan Drug Sales Offer a Glimpse of ‘Sheer Greed’”;


Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people whose rare diseases had been ignored. Drugs approved as orphans are granted tax incentives and seven years of exclusive rights to market drugs that are needed by fewer than 200,000 patients in the U.S.


In recent months, reports of five- and six-figure annual price tags for orphan drugs have amplified long-simmering concerns of abuse of the law. The senators' call for a GAO investigation reflects that sentiment.


The senators asked the GAO for a list of drugs approved or denied orphan status by the Food and Drug Administration. It also asked whether resources at the FDA, which oversees the law, have "kept up with the number of requests" from drug makers and whether there is consistency in the department's reviews.


The Kaiser Health News investigation found that many drugs that now have orphan status aren't entirely new. More than 70 were drugs first approved by the FDA for mass-market use. Those include cholesterol blockbuster Crestor (read “#Pharma Welfare: ‘Orphan’ Blockbuster Drugs on Rise - Including Crestor!;, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the world's best-selling drug.


Others are drugs that have received multiple exclusivity periods for two or more rare conditions. About 80 drugs fall into this category, including cancer drug Gleevec and wrinkle-fighting drug Botox.


Further Reading:


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Overhyped Drug Ads Are Often “Pain Points” for Some Physicians

Overhyped Drug Ads Are Often “Pain Points” for Some Physicians | Pharmaguy's Insights Into Drug Industry News |

The major “pain point” between healthcare professionals and drugmakers is trust, and pharmaceutical ads often get in the way of that trust, Dr. Joseph Habboushe, a physician at NYU Langone Medical Center, told attendees at ePharma.


“Us doctors, we get advertised to constantly, and it's not always the most straightforward way,” said Habboushe, who is also CEO of MDCalc, a medical score provider.


Oftentimes, drugmakers blur the lines between a drug's benefits and risks, quoting drug benefits in relative risks and actual risks in absolute value, making the benefits appear substantial and the risks less significant, noted Habboushe, while speaking Tuesday at the annual conference in New York City (read, for example, Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;


“Doctors start sensing this and at the end of the day, we don't fully trust our medical references,” said Habboushe. “We look for messaging from pharmaceutical companies not necessarily to help us treat our patients but to some extent to flag and discredit it.”


“What works for us is not just a flashy advertisement as much as, ‘Here's information that will help with the decision you're making now,” said Habboushe. “‘Or by the way, there's this new drug out there, and there are some other patients you might see tomorrow [who may be suitable for it.]''”


Transparency is key, agreed all speakers on the panel. The more drugmakers get comfortable with sharing negative as well as positive information, the more healthcare professionals will trust them and their messages, said Rohit Heryani, senior manager of multichannel marketing at Daiichi Sankyo.


Further Reading:

Pharma Guy's insight:

It’s appropriate that this discussion took place on the Intrepid aircraft carrier. It’s going to take more than a panel discussion to move the “aircraft carrier” issue of transparency in drug ads and promotions to physicians.

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Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists

Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists | Pharmaguy's Insights Into Drug Industry News |

[Authors: Nathan Gay, MD, is an oncology fellow at Oregon Health and Science University. Vinay Prasad, MD, is assistant professor in the Division of Hematology Oncology at Oregon Health and Science University and the author of “Ending Medical Reversal.” The views expressed in this article are the authors’ personal opinions and do not represent those of OHSU].


People with cancer face many challenges, including the symptoms of the disease, the toxicity of the treatment, financial costs, and social expectations. Here’s a new threat: navigating their care in an ocean of hype.


Cancer drugs are all too often hailed as miracles, breakthroughs, game-changers, or even cures, even when they are no such thing. We recently reported in JAMA Oncology that these words were used 50 percent of the time to describe drugs not approved by the FDA, and 14 percent of the time to describe drugs that had only worked in mice (read “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”;


Even when we do have drugs that work, hype may mislead us about how well they work and how many people they will benefit.


Consider immunotherapy. This new form of cancer therapy, which uses the body’s own immune system to fight cancer, has captivated the public imagination, is a topic of the nightly news, and has been featured in at least one Super Bowl ad.


Using US national cancer statistics and FDA approvals, we estimated the percent of cancer patients who might actually benefit from immunotherapy. The result was surprising, given the way these drugs are described.


To do this, we first calculated the percent of cancers for which immunotherapy has been approved as of February 2017. From that number we determined that two-thirds (68.8 percent) of Americans predicted to die of cancer will die of one that currently has no FDA-approved immunotherapy options. These include prostate cancer, colon cancer, and ovarian cancer, among others.


We next determined the percentage of cancer patients that could expect to see their tumor shrink from immunotherapy. Tumor shrinkage is widely considered to be a prerequisite to benefitting from these drugs. Only 26 percent of patients had this happen.


Finally, we combined those two calculations and asked, of all patients dying of cancer in America this year, how many might benefit from a checkpoint inhibitor drug? We assumed the best-case scenario: that every patient with one of these cancers could afford the drug and get access to it.


The answer was just 8 percent. We also ran the numbers another way by setting a lower bar for success, and credited these drugs for any patient whose cancer did not grow substantially during follow-up. Even with that adjustment, the estimate was less than 10 percent.


The intrusive nature of hype — without context, without nuance, and without limit — can be a huge challenge faced by cancer patients in America. For that reason, it should come as no surprise that many cancer patients have an inflated understanding of their prognosis compared to what their doctors understand. Too many patients and their families are inevitably let down when they find themselves among the 90 percent who don’t benefit from immunotherapy.


Further Reading:



Brian Chew's comment, March 9, 8:50 AM
This is discouraging for many, especially cancer patients and their friends and relatives. This would mean that the magical cure for cancer that was so hyped about was actually just false hope. Although it is slightly successful, the chances of it working are still low. Furthermore, it is not as effective or amazing as it sounds in advertisements or on paper. This is extremely discouraging, however, it is the hard truth. Cancer is an extremely hard disease to treat and it would take a lot more time and effort to actually produce an amazing safe and cheap method to cure cancer. However, all we can do is support these cancer patients right now and hope that such an amazing cure for cancer could be found soon.
Pharma Guy's comment, March 9, 9:22 AM
I agree. It's a long shot, but there are no magic bullets.
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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