Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Trump Nominates a Pharma Fox to Run the HHS Henhouse

Trump Nominates a Pharma Fox to Run the HHS Henhouse | Pharmaguy's Insights Into Drug Industry News |

President Trump's pick for health secretary previously served as a high-ranking executive at a pharmaceutical company that repeatedly raised the prices of its drugs, doubling the U.S. list price of its top-selling insulin over the five years he served as a company president.


Trump endorsed Alex Azar, a previous deputy secretary of Health and Human Services under President George W. Bush and pharmaceuticals executive at diabetes pharmaceuticals giant Eli Lilly, as “a star for better health care and lower drug prices” on Twitter.


Supporters said that Azar's understanding of the complicated dynamics behind pharmaceuticals pricing would give him an advantage in figuring out how to make drugs more affordable. Critics, however, noted that Azar's tenure at Lilly coincided with massive list price increases on insulin and made him particularly ill-suited to lower drug prices.


While Azar led Eli Lilly's largest affiliate, Lilly USA, the U.S. list price of Humalog insulin more than doubled, from $123 per vial in Jan. 2012 to $255 per vial when he left the company in early 2017, according to data from Truven Health Analytics. Lilly, along with other insulin makers, was hit by a class-action lawsuit alleging overpricing of insulin earlier this year.


“Alex had a successful career at Lilly, and we wish him the best in his future work,” Lilly spokesman Greg Kueterman said in an email.


Azar joined Lilly in 2007 as a senior vice president of global corporate affairs and communications. He rose to become president of the company's largest affiliate, Lilly USA, in 2012. Kueterman said his responsibilities included direction over the sales and marketing operations of the entire U.S. commercial business, including diabetes.


“This is the terrible record on price that we saw; now we’re talking about putting him in charge of the people's health agency — what reason do we have to expect any difference?” said Peter Maybarduk, director of the Access to Medicines Program at Public Citizen, a watchdog group. “It's a pharma fox to run the HHS henhouse.”


Further Reading:

  • “If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse”;
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Big Pharma Leaders Endorse Trump’s Protectionist Policies to Compensate for “Innovation Woes,” Says Former Industry Exec

Four pharma CEOs (from Lilly, Merck, Pfizer and Celgene) have signed a letter to congressional leaders voicing support for a tax reform that would let them repatriate, under advantageous tax treatment, tens of billions of dollars parked overseas.


Their letter, which was co-signed by several CEOs of non-pharma companies, can be seen here. In plain English, it translates as: "Our tax system is a mess. High taxes put us at a comparative disadvantage to our international competitors. We must nullify the advantage we gave them by imposing punitive border taxes."


What is worrisome is that the pharma leaders' endorsement of protectionist policies fits in a pattern of addressing their companies' innovation woes by relying on strategies that produce none of it—typically financial ploys, lobbying, and regulatory gimmicks. They include recurrent mergers & acquisitions, tax inversions, share buy-backs, runaway prices, coupon games, orphan designations for some of their biggest drugs, patent fortresses around aging biologicals, and arcane regulations in international treaties to blunt competition. It may buy them some time, but that is little relief. What they need is innovation. Unless they start producing more of it, the rest is delusion.


We expect better of our pharma CEOs. For now though, these get a dunce cap.


Pharma Guy's insight:

Further Reading:

  • “Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group”;
  • “Pfizer, U.S. Law Breaker & Tax Evader, Launches an Ad Campaign to Improve Its Rep”;
  • “Tax Evader #Pharma Mylan Reprimanded for Doing Little to Stop Use of Its Drug for Executions in U.S.”;
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Taltz DTC Ads Channel Opdivo Ads by Promising to Give You a “Chance” at Amazing Results

Taltz DTC Ads Channel Opdivo Ads by Promising to Give You a “Chance” at Amazing Results | Pharmaguy's Insights Into Drug Industry News |

Eli Lilly’s aggressive Taltz DTC advertising [which promises to “give you a chance at completely clear skin”] seems to be giving the new-to-market drug a boost in the next-generation psoriasis drug battle against Novartis' Cosentyx.


“In just one quarter, from Q3 to Q4, the percent of dermatologists receiving a patient request for Taltz at tripled,” Lynn Price of Spherix Global Insights said in an email interview. “What is important is that 43% of the patient inquiries resulted in a prescription for Taltz. I do not think that it is a coincidence that this significant bump in requests occurred directly post-launch of Lilly’s direct to consumer campaign.”


Lilly has spent more than $21 million on TV advertising for Taltz since launching the campaign in late September, according to data from real-time TV ad tracker Novartis has a longer running ad campaign Cosentyx that has tallied $75 million in TV ad spending since launching in January, according to iSpot data.


More IL-17 inhibitors to treat psoriasis are expected to win FDA approval, including Valeant’s proposed Siliq, which received an FDA advisory board recommendation in July,—although the committee was split on the risk management of the proposed drug due to reported suicides.


While two-thirds of dermotologists said the suicide risk is a “huge deterrent” to prescribing the drug, Price said, still about half agreed that if Valeant prices aggressively and it is cheaper than Taltz and Cosentynx, they will prescribe it ahead of the others.

Pharma Guy's insight:

This ad campaign reminds me of the Opdivo “Chance to Live Longer” TV ads, which have been criticized by Oncologists for overpromising (read “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”;

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@LillyPad Commissions "The Hero's Journey" - Crowdsourced One Brick at a Time

@LillyPad Commissions "The Hero's Journey" - Crowdsourced One Brick at a Time | Pharmaguy's Insights Into Drug Industry News |

Coined by scholar Joseph Campbell, “The Hero’s Journey” is a familiar trope in myths and stories – a hero sets out on an adventure, encounters setbacks, is transformed and eventually returns home.


“It’s a story that’s as old as humanity,” said John Magnan.


Using the same title, the latest project of the Mattapoisett sculptor looks at that journey through the scope of patients who undergo clinical trials and the community that surrounds them.


Commissioned by Eli Lilly and Company, a multinational pharmaceutical company based in Indiana, Magnan is creating three elaborate structures of wood and light that incorporate the journeys of patients and the greater clinical drug trial community to raise awareness.


“What’s important about clinical trials is that’s how drugs get approved. We can’t get new medicines out there healing people unless we test it on people,” Magnan said. “I knew art could inspire people to look into clinical trials and potentially take action and also be used to validate and honor the patient experience.”


The project also has a crowdsourcing element, something that immediately drew Magnan to the project.


“The art is not finished without the physical participation of the clinical trial community. That really captured my imagination,” he said.


Magnan created 2,000 wooden bricks that will be sent to patients, members of the medical community, caretakers and others through the One Brick, Your Voice campaign, designed by Magnan’s wife Annie Jonas. Participants who request a kit will receive a brick on which to paint, paste, draw or write something related to their experiences with drug trials. The kits will also contain a replica of one of the cairns, made by Jonas, to keep.

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Is Cymbalta Withdrawal "Zapping" Patients' Brains?

Is Cymbalta Withdrawal "Zapping" Patients' Brains? | Pharmaguy's Insights Into Drug Industry News |

Eli Lilly & Co. was ordered to face claims it misled consumers about “brain zaps” and other withdrawal side effects tied to its antidepressant Cymbalta in the first cases slated to be heard by juries.

Lilly’s bid to have former Cymbalta users’ lawsuits thrown out was rebuffed by a federal judge in California, who found they raised legitimate questions about the drugmaker’s warnings about withdrawal risks.

Jurors must decide whether Lilly officials designed Cymbalta studies to “under-report the risk of discontinuation symptoms,” U.S. District Judge Steven Wilson in Los Angeles ruled June 19. He set the first two trials in his court for August.

‘Brain Zaps’

The drugmaker faces more than 5,000 cases claiming it downplayed Cymbalta’s withdrawal side effects, which allegedly include electrical-shock sensations described in court filings as “brain zaps.” Other withdrawal effects are said to include nausea, vomiting and insomnia.

“We believe in our defenses to these claims and we will continue to defend Lilly vigorously,” Scott MacGregor, a Lilly spokesman, said Wednesday.

The patients contend Lilly executives downplayed the withdrawal risks on the drug’s warning label, saying only about 2 percent of users experienced side effects when coming off the medication, according to court filings.

Studies have found more than 40 percent of Cymbalta patients suffered withdrawal after quitting the medicine, the consumers said in court filings.

Pharma Guy's insight:

Lilly disclosed on warning labels in Europe that 45 percent of users reported experiencing some withdrawal symptoms after they stopped taking the drug, the patients said in court filings. Why only in Europe? What's FDA say about this?

This may be a case where side effects are more frequent in real life than in clinical trials that only last for a few weeks -- see here:

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▶ Boehringer Ingelheim and Eli Lilly and Company Diabetes Awareness Video - YouTube

Diabetes is a common medical condition affecting 382 million people today; and that number is on the rise. Without careful management, diabetes can lead to s...
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Big Pharma exec turned Whistleblower - YouTube

Big Pharma exec turned Whistleblower - YouTube | Pharmaguy's Insights Into Drug Industry News |

Dr. John Rengen Virapen, former Eli Lilly & Co executive who after 35 years of service decided to quit and speak out about Big Pharma's method for profit and the benefit of symptomatic diseases that people live with for the duration of their lives. This is a video that was uploaded to Youtube on Jul 15, 2009.

Pharma Guy's insight:

I interviewed Dr. Virapen about the allegations he made in his book "Side Effects: Death" in 2007. Listen to that podcast here.

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Drug Industry Document Archive - Off-Label Marketing of Zyprexa

Drug Industry Document Archive - Off-Label Marketing of Zyprexa | Pharmaguy's Insights Into Drug Industry News |

The documents in this collection are a portion of those produced in a class action court case that alleged Eli Lilly withheld data on adverse effects such as weight gain and diabetes and participated in off-label marketing of the drug. The documents were first obtained and made public in 2006 by, expert consultant Dr. David Egilman, attorney Jim Gottstein, and journalists Philip Dawdy and Alex Berenson. After a legal battle over public access, the documents were un-sealed and allowed to remain in the public domain.  These documents highlight Lilly's marketing strategy of influencing key opinion leaders and its attempts to control the research, the scientific literature and regulatory product labeling to minimize information on adverse effects.

Pharma Guy's insight:

This database of documents is interesting, especially in light of FDA's new draft guidance on the distribution of off-label reprints. For more on that, read 

FDA Issues More Guidance Regarding Distribution of Reprints. Is It "Fair and Balanced?"
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Former Lilly President Says Stories of Demise of Sales Reps are “Greatly Exaggerated”

Former Lilly President Says Stories of Demise of Sales Reps are “Greatly Exaggerated” | Pharmaguy's Insights Into Drug Industry News |

Ever wish you could pick the brain of a pharma insider who not only has deep knowledge of the pharmaceutical industry, but also has their pulse on Washington?


That was exactly what Matt Wallach, co-founder and president of Veeva, did during his company’s annual Veeva Summit held in Philadelphia earlier this week when he interviewed pharmaceutical and healthcare industry expert Alex Azar in a fireside-type chat in front of more than 1,300 attendees.


Azar, who most recently served as president of Lilly USA before leaving in January to pursue other professional opportunities, also has extensive experience in the public health sector, having served first as general counsel of the U.S. Department of Health & Human Services, before becoming deputy secretary under Mike Leavitt.


Here are some brief snippets of what he had to say about the future of the sales representative:


“Stories about the death of the sales rep are greatly exaggerated,” said Azar.


He believes that in many instances the sales rep position is still the highest ROI tactic for many brands.


“As a corporate leader, there is nothing like when a sales rep goes on vacation and you get a call from the doctor’s office asking, ‘what happened to our rep?’” he said. “These people are intimately involved in helping physicians with caring for their patients.”


The problem, Azar says, can be access.


“Access [to doctors] is getting worse, but it’s not as bad as some suggest, especially if you are an established pharmaceutical company,” he said.


Azar relayed an example of how when he was with Lilly, the company created a suite of interactions to test how influential they could be at reaching physicians that categorically were considered “white space”—those that were never called on by a rep.


Over a period of six months, Lilly engaged the physician in a variety of touch points—peer-to-peer videos, direct mail, email, etc. He said the company was able to convert 18% of those who never saw a rep from its bottom tier to its top tier of advocacy.


“That tells me it can work, but I don’t think it can replace the rep,” Azar said.


When it comes to account management, he says the sales rep position plays a huge part.


“Sales reps don’t just do short sales,” he said. “They build relationships over the long term and add value over time.”


Further Reading:


  • LinkedIn: “Benefits and Risks of Limiting Pharma Sales Rep Access to Physicians”:
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Lilly CEO David Ricks Likes Medicare Just the Way It Is: A “Good Model Going Forward”

Lilly CEO David Ricks Likes Medicare Just the Way It Is: A “Good Model Going Forward” | Pharmaguy's Insights Into Drug Industry News |

Eli Lilly's growth is not fueled by increasing drug costs, CEO David Ricks told CNBC on Wednesday, a day after he and other Big Pharma leaders met with President Donald Trump at the White House.


Appearing on "Squawk Box," Ricks defended Lilly against charges that drugmakers actively try to inflate costs for profit, using the firm's earnings, released on Tuesday, to support his position.


"Price played a 1 percent role in pharmaceutical growth that was 9 percent," said Ricks, who became CEO last month. "Pricing gets a lot of press, but it's actually not playing a key role in our return to growth."


Trump told the drugmakers he wants to make it easier for pharmaceutical companies to win regulatory approval for their products. As he's done with other industry leaders, he also called on the CEOs to bring manufacturing back to America (read “Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare”;


On the topic of lowering drug prices, Ricks said Medicare Part D prescription drug coverage for seniors should be a model.


"They are fiercely interested in negotiating down drug prices, but also concerned about keeping customers and having choice," he said. "We think that balance is just about right, and that that piece of government legislation ... is really the model going forward."

Pharma Guy's insight:

Meanwhile... The rising price of insulin has found its way to a federal court, where several consumers are accusing the three biggest manufacturers — Sanofi, Eli Lilly, and Novo Nordisk — of running a coordinated scheme that has caused patients economic harm (read “Major #Pharma Companies Sued for Colluding to Raise Insulin Prices”;


. Further Reading: “Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?”;

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Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs

Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs | Pharmaguy's Insights Into Drug Industry News |

Despite his defeat in the primary, popular Vermont Senator Bernie Sanders continues to lend his star power to the principals of the political revolution, taking aim Tuesday at a pharmaceutical company that raised the price of a life-saving insulin drug—and Wall Street is taking notice.

Tuesday morning, Sanders criticized pharmaceutical company Eli Lilly, which raised the price of its insulin drug Homolog (sic) by 700 percent in 20 years when adjusted for inflation.

In a tweet to his 2.7 million Twitter followers, the Vermont Senator posted a Washington Post graph showing the cost of Homolog has risen from $21 to $255 since 1996. Sanders blamed “the drug industry’s greed” for profiting off those in need.

Pharma Guy's insight:

Is Bernie short-selling the stock of pharma companies he criticizes?

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AHA Cholesterol Guidelines Panel Vice Chair Finally Discloses Receiving $ from #Pharma

AHA Cholesterol Guidelines Panel Vice Chair Finally Discloses Receiving $ from #Pharma | Pharmaguy's Insights Into Drug Industry News |

In 2013, the American Heart Association issued new guidelines for treating cholesterol, causing a stir that more patients may wind up being treated with medicines. As part of that process, the expert panel members who oversaw the document disclosed their financial ties to drug makers. But one large payment was not divulged.

The panel vice chair did not disclose nearly $110,000 in research grants received from Eli Lilly for running tests for an experimental cholesterol treatment. 

Robinson said the decision not to disclose the Lilly payments was, essentially, a timing issue. She began work on the Lilly study shortly after the AHA panel completed the guideline recommendations and submitted them for publication. This submission also occurred before she received any payments from the drug maker.

“The Eli Lilly study started after the guideline recommendations were completed, so it was not on my radar to report,” she wrote. She added that the funds were paid to the university to cover the cost of the research she was conducting, which is a standard price. “They are not direct payments to me,” she added.

The AHA further explained that Robinson abstained from voting on the recommendations because of her financial ties to several other drug makers, which had been disclosed.

One labor union, which first reported the failure to disclose the Lilly payment and is critical of financial ties between industry and the AHA, worries such relationships can raise health care costs. “The AHA should prohibit its authors and leadership from accepting industry payments,” said Arthur Phillips, a research analyst at Unite Here.

However, industry and some researchers argue completely severing ties is not practical, because they say the most qualified experts often have relationships with drug makers.

Pharma Guy's insight:

So, the drug industry has all of the most qualified physicians on its payroll? Thereby making conflict-of-interest inevitable?

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Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus!

Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus! | Pharmaguy's Insights Into Drug Industry News |

Back in December, 2014, I reported in Pharma Marketing News that the FDA was planning to study "Spousal Influence On Consumer Understanding Of And Response To Direct-To-Consumer Prescription Drug Advertisements" (see "Does Your Spouse Influence Your DTC Viewing Experience?").

At about the same time, the new ad for Viagra, which featured a sexy woman (no man), aired on TV (read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Of course, I thought the FDA should study how wives (or significant other spousal equivalent) might influence their spouses' (i.e., husbands') response to THAT ad.

But, no, the FDA will be using asthma drug ads in their study. Huh?!

It appears, however, that the FDA is using a benign drug category to get results that it may use against Viagra and other male/female enhancement drug ads. AbbVie and Eli Lilly -- two marketers of lifestyle-enhancing drugs for men -- recognize this ploy and have submitted comments to the FDA in an attempt to shoot down the study.

What's their beef? Read more here: 

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Clinical Research Site Professionals Focus on Improving Lives

Clinical Research Site Professionals Focus on Improving Lives | Pharmaguy's Insights Into Drug Industry News |

Clinical research site professionals (investigators, site directors, study coordinators, and pharmacists) play a very important role in shaping a clinical trial volunteer’s experience. That role can be a complex one, as they work to build bridges between the sponsor’s goals for a trial, the physician’s care plan for the volunteer, and the volunteer’s own needs and wishes. They are often “the face” of the trial, and provide the much-needed personal connection for patients as they navigate the process of participating in a trial.

We know there’s a lot we can learn from their experiences and insights. We recently created a Lilly Innovation Site Advocacy Group to help keep the lines of communication open and encourage innovative thinking around improving the clinical trial experience. Our hope is that we can make site professionals jobs a little easier, and offer exceptional trial experiences for patients.

Leigh Anne Naas, a member of our Lilly Clinical Innovation team, recently asked a few site professionals about their connections with their clinical research patients.

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Former Lilly in Sweden Insider Talks Side Effects and Death

Former Lilly in Sweden Insider Talks Side Effects and Death | Pharmaguy's Insights Into Drug Industry News |

The former managing director of drug giant Eli Lilly and Company in Sweden continues to reveal the business practices of the pharmaceutical industry, scoring a major victory in announcing that his first book, Side Effects: Death. Confessions of a Pharma-Insider, will be turned into a full-length feature film.

John Virapen, who began his career with “Big Pharma” in 1968 as a salesman knocking on doctors’ doors, rose through the ranks to realize what he was pitching were not drugs, but death. Virapen was well aware early on that thousands had died or committed suicide by taking the drugs he was pushing. “I indirectly contributed to the death of . . . people, whose shadows now haunt me,” he explained in his book.

Dave Gahary had the opportunity to sit down with Mr. Virapen to discuss how he got into bed with Big Pharma, what motivated him to write this book, and what his long-term goals are, in this informative interview (15:36).

Pharma Guy's insight:

John Virapin was first interviewed by PharmaGuy back in 2007 on this Pharma Marketing Talk show: A Former Lilly Insider Blows the Whistle on Criminal Activity in Sweden

lorraine cleaver's curator insight, October 27, 2014 8:13 PM

This guy knows what we are up against. The continual polypharmacy that feeds profit yet keeps us ill. Chronic patients - the gift that keeps on giving.