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FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation

FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act.


President Barack Obama’s nominee for FDA commissioner, who has come under fire for his past relationships with industry, was aware of the partnership between the agency and the device lobbying group on legislative proposals, according to the emails and documents, and attended meetings with the group along with FDA's acting commissioner and the device center director.


The agency defended the meetings with the device lobbying group as standard procedure and said that Congress requested technical assistance from FDA on the Cures legislation. And, while congressional sources claimed the practice of soliciting outside opinion on legislation was critical to the legislative process, sources off Capitol Hill said they were alarmed at the level of coordination between the agency and the device lobbying group and the amount of influence both parties had over the Cures legislation.


On Aug. 7, FDA officials, including Acting Commissioner Stephen Ostroff, Deputy Commissioner and Commissioner-nominee Robert Califf and Center for Devices and Radiological Health chief Jeff Shuren met with representatives from the Advanced Medical Technology Association (AdvaMed), including Steve Ubl, who then headed the association and is now president of the pharmaceutical drug lobby group, and Janet Trunzo, AdvaMed senior executive vice president of technology and regulatory affairs, as well as individuals from Johnson & Johnson, CVRx Inc. and St. Jude Medical Center.


A background document shared in advance of the meeting with a number of FDA officials, including Califf and Shuren, as well as Larry Morris, executive assistant to Ostroff, Sally Howard, senior advisor and acting chief of staff to Ostroff and Franklin Joseph, associate chief counsel for the agency, notes that FDA and AdvaMed met regularly during the legislative process and that the agency and the device lobbying arm had jointly written legislative text for Energy & Commerce Chairman Fred Upton’s (MI) signature piece of legislation.

Pharma Guy's insight:

Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

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Big #Pharma Reluctant to Develop Zika Vaccine Without Gov't Funding

Big #Pharma Reluctant to Develop Zika Vaccine Without Gov't Funding | Pharmaguy's Insights Into Drug Industry News | Scoop.it

What if a drugmaker spent billions of dollars to create a vaccine -- only to find out humans developed natural resistance to the disease before its product is ready?

 

That is part of the scenario GlaxoSmithKline Plc and other pharmaceutical giants are weighing in their cautious approach to developing a Zika vaccine.

 

Large portions of the populations in Zika-affected areas could develop immunity to the virus over the next five to 10 years, slowing its circulation into virgin areas, said Moncef Slaoui, chairman of London-based Glaxo’s vaccines division. That would make it harder to determine the market for a vaccine, which could be just stockpiled for outbreaks rather than used widely during national immunization campaigns.

 

So far, Sanofi is the only major pharmaceutical company forging ahead with Zika vaccine development. The French drugmaker will begin testing on animals this quarter, and plans to start tests in people next year.

 

“We have scientists, clinicians, toxicologists, epidemiologists that understand this family of viruses,” said Nicholas Jackson, who heads the Zika vaccine project for Sanofi. “This gives us a great opportunity to move quickly, and quick is needed here.”

 

While Glaxo, J&J and Merck are among the world’s pre-eminent developers and manufacturers of inoculations, they are absent from the list of companies that have shared details with the WHO on vaccine candidates.

 

Some manufacturers may be hesitant to enter the Zika vaccine race because of the uncertainty around public funding in the U.S. After the White House requested $1.9 billion, the Senate last week endorsed a $1.1 billion compromise package, and the House of Representatives passed a $622 million plan. The Obama administration, calling it “woefully inadequate,” has threatened to veto the legislation.

 

“This is not seen as a commercial market, at least for the time being,” said Marie-Paule Kieny, an assistant director-general at the WHO.

Pharma Guy's insight:

So much for pharma's vaulted investment in R&D to meet an urgent medical need! Also read: "When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?"; http://sco.lt/7adpSb

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De Niro Gets to Have the Anti-Vaccine Discussion He Wanted on Today Show

De Niro Gets to Have the Anti-Vaccine Discussion He Wanted on Today Show | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Robert De Niro on Wednesday defended the notion that vaccines are linked to autism, resurfacing a discredited notion based on false science.

 

The star appeared on the “Today” show to promote the Tribeca Film Festival, which he helped found. But the segment was dominated by controversy over an anti-vaccination film called “Vaxxed,” which the festival pulled from this year’s program after a public outcry (see here).

 

The film was directed by discredited scientist-turned-activist Andrew Wakefield. At the time of its removal, De Niro had said that the film would not provide the conversation-starter he had hoped for. But in the interview Wednesday, he admitted that part of him regretted removing the film from the schedule. “As a parent of a child who has autism, I’m concerned,” he said. “And I want to know the truth. And I’m not anti-vaccine. I want safe vaccines.”

 

“There’s a lot of information about things that are happening with the CDC, the pharmaceutical companies, there are a lot of things that aren’t said,” De Niro said.

 

Even as Guthrie and cohost Willie Geist pointed out that there is no scientific evidence of a link between vaccines and autism, De Niro dug in his heels. “It’s much more complicated than that. There is a link, and they’re saying there isn’t,” he said.

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Sacré Bleu! French Authorities, CRO & Pharma Blame Each Other for Clinical Trial Death

Four months after a clinical trial in France left one person dead and five others hospitalized, French authorities blamed the clinical research organization and drug maker for various lapses and moved to tighten procedures for testing medicines. The CRO, however, castigated authorities for their findings and blamed the medicine for causing the serious patient reactions.

 

In a 271-page report released today, France’s social affairs inspectorate, known as IGAS, concluded that Biotrial, the CRO that oversaw the early-stage study, failed to properly manage the testing. Notably, the agency found that Biotrial continued to administer the drug even after one patient was sent to the hospital, and it failed to confirm patient consent before running the trial.

 

Overall, the CRO failed to “implement the optimal level of protection for volunteers,” the report stated. Compounding matters, the drug maker, Bial, and the CRO were both accused of taking too long to inform French health authorities of the serious adverse events, although the report cleared the National Agency of Drug Safety of wrongdoing.

 

The drug maker also maintained it did not have access to the patient autopsy in order to investigate possible causes, there was no reason to modify dosing, and that trial protocol was approved and followed. “There were no alerts, or signals in any of the safety parameters collected from any of the previous cohorts that could have anticipated the tragic accident,” the company said.]

 

For its part, Biotrial issued a scathing statement, saying the company “deplores this situation,” especially since it “respected” the trial protocol that was approved by French health authorities. And the CRO blamed the drug for its “unexpected and unpredictable toxicity, which is at fault for the accident.”

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Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies

Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The revenue growth opportunity in vaccines looks far more promising when compared to the overall market for pharmaceuticals. Revenues earned by vaccines manufacturers worldwide reached $27.6 billion in 2015 according to Kalorama Information, up 11% from $24.7 billion in 2014, as sales in all segments expanded. This is, by Kalorama’s estimate, at least five to ten times the revenue growth rate of the overall pharmaceutical market in recent years. The world vaccines market is predicted to increase at a compound annual rate of 7.6% during 2013–2022, reaching $45.1 billion in 2022 as new product introductions continue and usage of current products expands further.

 

The world vaccines market is dominated by four major competitors: Sanofi Pasteur, GlaxoSmithKline, Merck & Co., and Pfizer. Pfizer and Merck hold 45% of the market. As the market leader in 2015, Pfizer’s vaccine sales exceeded $6.4 billion on strong growth of its Prevnar family, giving the company 23.3% of the market. Pfizer was followed by Merck with $5.9 billion.

Pharma Guy's insight:

Also read: "When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?"; http://sco.lt/7adpSb 

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Another #Pharma Film About Psoriasis Awareness - This Time by Celgene

Another #Pharma Film About Psoriasis Awareness - This Time by Celgene | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Celgene has released a fictional film to raise the profile of the physical and social challenges people living with psoriasis and psoriatic arthritis face every day.


The short film - Millefeuille (A Thousand Leaves) - tells the story of Élodie, a Frenchwoman who was forced to give up her career as a pastry chef due to her struggles with the effects of psoriasis and psoriatic arthritis.


Lee Heeson, vice president of inflammation and immunology at Celgene EMEA, said: “We believe that 'coping' is not good enough and that patients deserve more.


“It is our hope that using an approach which goes beyond the 'standard' definition of disease information - and uses fiction to bring the message to life - can help those who are less motivated or not seeking psoriasis education, to challenge the status quo and live better lives.”

Pharma Guy's insight:

This is not the first psoriasis film produced by a pharmaceutical company. Back in 2007, Centocor produced Interspace, which focused on rheumatoid arthritis (RA), Crohn's disease, and psoriasis. Here's how the film is described in Centocor's press release:

 

"...a first-of-its-kind documentary providing insight into the 'inner states' of three everyday adults facing chronic, life-altering inflammatory diseases. As they confront daily challenges and life's experiences, they tell the emotional stories of their journeys toward living 'normal' lives in a film that is sure to touch the hearts of all viewers, including the millions of Americans who suffer from these conditions."

 

Learn more about this film and how I got invited to a private screening here: http://pharmamkting.blogspot.com/2007/03/innerstate-private-screening.html 

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The Real Reason Big Pharma Wants to Help Pay for Your Prescription

The Real Reason Big Pharma Wants to Help Pay for Your Prescription | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Fueled almost entirely by drugmakers’ contributions, the seven biggest copay charities, which cover scores of diseases, had combined contributions of $1.1 billion in 2014. That’s more than twice the figure in 2010, mirroring the surge in drug prices. For that $1 billion in aid, drug companies “get many billions back” from insurers, says Fugh-Berman.
“Drug companies aren’t contributing hundreds of millions of dollars for altruistic reasons,” says Joel Hay, a professor and founding chair in the department of pharmaceutical economics and policy at the University of Southern California. The charities “don’t ever have to scrounge for money. It falls right to them.” Both Hay and Fugh-Berman have served as paid expert witnesses in lawsuits against drug companies.
When Turing bought Daraprim and sought to boost its annual revenue from $5 million to more than $200 million, the use of patient-aid funds was considered essential, internal company documents show. Last May, as the company did its due diligence before the purchase, one executive warned in an e-mail that new, high copays would force toxoplasmosis patients to seek alternative drugs.
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Most UK HCPs OK with Revealing #Pharma Payments to Docs, But...

Most UK HCPs OK with Revealing #Pharma Payments to Docs, But... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a poll of more than 500 UK healthcare workers carried out for the Association of the British Pharmaceutical Industry, 87 percent believe payments from pharma companies to individually named healthcare professionals should be transparent, with around two thirds (64 percent) saying that this information should be publicly declared.

 

However, a significant chunk - 26 percent - felt disclosure of payments to individually named HCPs is unnecessary, and 24 percent feared the move would adversely affect medical innovation, while 26 percent also felt their relationships with pharma companies would change as a result.

 

The ABPI is just weeks away from publishing details of payments and benefits in kind made to UK HCPs and healthcare organisations on an online, publicly searchable database under its drive to improve transparency and trust in the industry.

  

Nevertheless, while being largely supportive of the move, 69 percent of respondents did express concerns about the process. The biggest concern is potential misrepresentation of data (49 percent), closely followed by possible negative perceptions among the public (44 percent), data protection (43 percent) and potential media coverage (35 percent).

Pharma Guy's insight:

I bet the poll did not ask docs if revealing payments should be mandatory. For more on that, read: "Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?"; http://sco.lt/62C1vF 

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Mom to Bayer: "Would You Implant This in Your Mother...?"

Mom to Bayer: "Would You Implant This in Your Mother...?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The following is a letter from E-Sister Brianne Savino:

 

Dear Bayer,

I find myself writing this with no expectation that this will be read by anyone at your company that holds any merit. However, I hold onto a small vestige of hope that this will not only be read but also understood. You are a very large and successful corporation. Your company has offered many products that have helped countless lives and there is something to be said for that.

Nonetheless, you have made a mistake. As children we are taught that mistakes are allowed as long as we learn from them and correct ourselves. You bought and distributed a product known as Essure. You successfully promoted it and it is now widely known and used. For some this product has been wonderful and others it has become a living nightmare from which we cannot wake. Many of us are suffering and what I want to know is ‘do you care?’ I understand that a large corporation must pay heavy attention to their bottom line but I urge you to look below that. We are not numbers and statistics. We are human beings.

With all the negative reports that you have flooding in I would like to ask each one of you that continue to market and promote this product, ‘Would you implant this is your mother, sister, wife, or even your daughter?’ That’s what we are, we are not complaints or negative press. We are mothers, sisters, wives and daughters. Every one of us owns one or more of those titles. How do we get through to you? If not by a moral compass than what?

Many of us, myself included, have no means to get help with this. I am a single mother to 5 children whom I support and take very good care of. I find myself in quite the predicament with healthcare. I make too much to get any help from a state agency and yet I make too little to get any help from the marketplace. You have spent millions in incentives to have doctors push your product and yet you are doing nothing to help the people that your product has hurt. Will you not do as we are taught as children?

Apologize and make things right. I suggest that you do some reading on the very large mistakes that GM has made, not only morally but financially as well. They were in a scenario much like yours. They had the information and the resources to correct the poor decisions that were made but they chose not to. Financially this has hurt them more in the long run than it would have if they had corrected it in the beginning and has sufficiently warped their reputation. Precious lives were lost because they were afraid of the financial aspect. Will that example open your eyes?

I beg you to see me, the real me. Not the case number or complaint number that I have been issued. Me, the person, the daughter, the mother that you have hurt. I may be just one measly person in the world to you but to my five children, I am the world. You are at a crossroads right now.

You can become the company that cares for profit margins only or you can become the company that cared enough to make things right. Very little comes before the almighty dollar these days, I am very well aware of that fact.

That being said, I know who I am and who my mother raised me to be. I would never put a price on a human beings life. To those that love us, we are priceless. I will ask one thing of the Bayer CEO, all the executives and employees that continue the fight to keep Essure as a safe, effective and permanent birth control before I close this letter.

When you lay your head on your pillow tonight, close your eyes, keep in mind all the hard evidence and facts of injury that have come before you with this product, now think of your mother wherever she may be.

Lastly, ask yourself one question…’Would she be proud of you and the decisions that you’ve made?’

Pharma Guy's insight:

Re: Essure It's a Flint, Michigan moment: Drink your own Kool-Aid and prove it's safe!

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Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?

Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmaceutical firms currently pay about £40m every year to healthcare professionals, including doctors and pharmacists. These payments could be for anything from expert advice to sponsoring a healthcare professional’s medical education. Now, the Association of the British Pharmaceutical Industry (ABPI) has created a central database, going live in June, on which its member companies, and others that have signed up to comply with the ABPI code of practice, will disclose who these payments are made to, and for what.

 

[For comparison, pharma has made over $6 Bn in payments to physicians in the U.S. in 2014. $3.2 Bn of that was for research – see chart above.]

 

How will this new transparency affect the complex matrix of relationships between health professionals, pharmaceutical firms, the NHS and, most importantly, patients? That was the underlying question under discussion at a seminar hosted by the Guardian and sponsored by the ABPI.

 

Sarah Boseley of the Guardian kicked off the discussion by pointing out that the ABPI database has already come in for some criticism: the Academy of Royal Medical Colleges says it doesn’t go far enough. But should disclosure be mandatory? Only 69% of healthcare professionals say they would agree to have their relationships with pharmaceutical companies disclosed on the publicly searchable database.

 

Ash Soni of the Royal Pharmaceutical Society agreed that disclosed payments need to be seen in the right context to be of value. “It’s important that there is an ability to respond and react to some of this disclosure.”

 

The panel members were in broad agreement that increased transparency is a good thing, whether it’s disclosing payments or publishing clinical research data – but, like Soni, Nikki Yates of GlaxoSmithKline (GSK) stressed the need for education around its issues. “The way I’ve embraced it [disclosure and transparency issues] is to take a step towards ensuring that whoever we are working with has a full understanding of why this is an important thing to do,” said Yates. Since 2014, she said, GSK has had a disclosure clause in its contracts. Thus far, it has had more than 90% agreement for disclosure of trial results. “And we’ve gone a bit further and said if we can’t agree on disclosure, then we won’t work with those individuals.”

 

[GSK has pledged that it will no longer pay doctors to promote its products. For more on that, read “GSK ‘Sunshine Blocks’ Outside Docs: No More $ For You!”; http://sco.lt/5ByCdV]

 

But GP Dr Margaret McCartney pointed out that talking about shared goals, partnership and collaboration is all very well – but what are the shared goals and who decides what they are? She cited the pharmaceutical researcher who had approached her practice to do clinical research. When McCartney asked him if results would be published no matter what they showed, she was told no, and that McCartney herself would not be allowed to make them public. “How can I trust a leadership that says it will not guarantee published results, no matter what they show?” she asked.

So should disclosure be required by law? McCartney said she was pleased with GSK’s advances in making clinical data public, but believed that the process has to be “enshrined in law”. Others were not so sure: Jackson was concerned with “over-sterilisation” of the system. “… if we legislate, and go too far, then we could end up stifling the system by not allowing it to breathe.”

 

Transparency in the interest of patients

But times are changing, said Soni. “The industry did have a very bad reputation and there is no doubt that it earned it. Some of the things it did were not in the interests of patients or for the best interests of care. However, the industry has changed – it’s had to. It had to realise some of the things it was doing were not of a suitable standard. And I think this is helping us to move further and further in the right direction.”

 

George Freeman, minister for life sciences took up this theme in his keynote address… “We have a choice between historically justifiable conspiracy theory, distrust and legislation as the only solution – the law or the threat of law, which I think drives defensiveness – or an approach based on mutual respect for others’ perspectives. [That approach] will accelerate us into this landscape of a more transparent healthcare ecosystem, which I think is genuinely in the interests of all of us.”

Pharma Guy's insight:

It seems to me that only mandatory laws requiring full disclosure of payments to physicians is the only way to go to achieve the type of "full transparency" that was bandied about by this panel. Recall that before the Sunshine Law took effect in the U.S. only a few pharma companies disclosed payments and only because they were required to do so by law. But more telling was the fact that the disclosures themselves were not transparent - several different data formats were used and some datasets were impossible to download for independent analysis and were not easily searchable (for more on that, read "Transparency Vs. Translucency in Reporting Physician Payments"; http://bit.ly/untranssunshine). The Sunshine Law changed all that!

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Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?

The maker of the pain pill OxyContin filed an appeal on Monday of a Kentucky judge’s decision to unseal records related to how the drug was marketed and what company officials knew about the addictive properties of the potent opioid.

The notice of appeal by Purdue Pharma, filed in Pike Circuit Court in eastern Kentucky, triggered the beginning of the appeals process and did not contain any legal arguments challenging the judge’s decision. After a month to six weeks of procedural matters, it is expected both sides will begin arguing the case in briefings to the Kentucky Appeals Court. That process could take up to five months. The appeals court, consisting of three judges, will then decide to either conduct oral arguments on the case or rule on the matter based only on the briefings.

Pharma Guy's insight:

You might also like to read these:

 

Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!; http://sco.lt/4kfBNB

 

Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic; http://sco.lt/8HgsU5

 

OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It; http://sco.lt/8RfD5F

 

The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic; http://sco.lt/6RajLd

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Are Pharma Marketers Really Responsible for "Patient Centricity/Engagement?"

Are Pharma Marketers Really Responsible for "Patient Centricity/Engagement?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For the last few years, most pharma companies have discovered (or is it rediscovered?) the healthcare consumer — putting patients at the center of their businesses with patient-centric thinking.

 

But who understands and represents the patient in big pharma? Marketers do [says David Anderson, managing partner at Insight NZ, a healthcare brand advertising agency. See my insights].

.

Marketers have a unique opportunity to be “the voice” of the patient within their organizations. What does this mean in practice?

 

1) Get into the patients' shoes. Understand their world. Understand their commonality and their diversity. Understand their journey from illness to wellness. What motivates them? Why do they make the decisions they make?

 

2) Include patients in the conversation. Make sure they're involved in their health, which means talking to them in a language that they can understand. Health literacy is low for many chronic conditions — so don't use “dyspnea” when you can say “shortness of breath.” And it's the flu, not influenza, no matter how much the medical team may hate that abbreviation.

 

3) Support physicians by augmenting the clinical information they have, so that they can deliver a more holistic healthcare solution.

 

4) Advocate for the patient in your organization. Patient needs should come first in all levels of your organization. At every opportunity advocate for your patients and share what you know. This will help others make patient-centric decisions in their roles.

Pharma Guy's insight:

The author of this piece, David Anderson, is a managing partner at Insight NZ, a healthcare brand advertising agency. He argues that, by definition, marketing is "patient centric": 

The UK Chartered Institute of Marketing defines marketing as: "… the management process responsible for identifying, anticipating, and satisfying customer requirements profitably."

 

"Profitability," however, often trumps (with a small "t") putting patients' interest first. If it weren't so, I would never have anything to write about! 

 

For an alternative view, read this: "Are #Pharma Medical Departments Responsible for 'Patient Engagement?'"; http://sco.lt/8wvM7F After reading that you will see that Mr. Anderson completely ignores the medical research side of the business, which marketers don't fully understand until after the fact it seems.

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Looking on the "Bright Side" of Metastatic Cancer Survival

A paper by Dr. Patricia Steeg of the National Cancer Institute (NCI) published in a prestigious journal, Nature Reviews Cancer calls out an “alarming” but debatable decline in survival in other advanced cancers, including ovarian, prostate and uterine tumors, and a general lack of progress against metastatic disease.

 

From 2000 through 2010, median survival for U.S. women with metastatic breast cancer increased from 22 to 30 months.

 

From 2000 through 2010, the 5-year relative survival for women with metastatic breast cancer rose, from 25.9% to 32.6%, This increase was statistically significant (confidence intervals: 24.9 – 27.0%, and 31.6 – 33.6%, respectively).

 

What this means, first, is that in the five years before 2000, half of women with stage 4 breast cancer lived for 22 months or longer; by 2010, half lived 30 months or longer. These findings are based on data in a public database (SEER 11), collected in the periods 1995-2000 and 2004-2010, respectively. As explained in a handy SEER glossary, “relative” 5-year survival indicates how long the cancer patients live compared to age and sex-matched controls in the population.

 

The low numbers might upset someone who is not aware of the fact that–despite so much progress against early-stage, local and “regional” breast cancers–metastatic breast cancer remains incurable. That most women with metastatic disease die within three years of diagnosis, still, or at least until 2010, is a very sad statistic.

 

On the bright side: Survival has gone up, and measurable progress was evident by 2010. I’d go as far to say that most likely, and almost certainly, survival continued to improve from 2010 and 2015. If you consider all the new drugs that have come out since 2010, particularly for estrogen-positive, hormone-sensitive breast cancer, the most frequent forms, and for Her2 positive cases, for which there are, now, quite a few helpful agents (there were none in 2000), and better diagnostic testing for tumor subtypes, that these medications can be prescribed sensibly, the outlook should be better now, in 2016. And by 2020, who knows?

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#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease

#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While drug development is typically thought of as the disease-centric process of finding a drug that can treat a disease, much effort goes in the reverse, drug-centric direction of finding a disease that can be treated by a drug. The diseases for which a drug is intended can change over the course of its development and post-marketing. During pharmaceutical development, new diseases can be selected or dropped at every stage of the pipeline on the basis of pre-clinical and clinical results. When a drug starts to show signs of success with a particular disease, additional diseases are sought to broaden the drug’s therapeutic and commercial appeal. Once a drug has been approved by regulatory agencies, its use may not be restricted to the diseases for which it was approved, as medical practitioners may prescribe it off-label. Indeed, a drug’s efficacy against certain diseases may only become fully apparent once it is consumed by a large number of patients or made widely available for scientific experimentation. New findings about a drug’s efficacy can prompt the original drug developer to seek supplemental indication approvals or pursue life-cycle management strategies such as combining the drug with other new or existing drugs.

This is not to say that drugs are created ex nihilo. They are generally designed with an intent rooted in biological rationale, such as to inhibit a disease-causing gene. However, the interconnected nature of human biology and of pathological mechanisms, the steady advance in our understanding of diseases and the potential lack of target selectivity means that drugs designed for a specific purpose can end up having different or additional applications. Once a drug is created it can fail with diseases for which it was designed and succeed with unanticipated diseases. Thus, drugs hold an intrinsic value based not only on their proven therapeutic effect but also on their therapeutic potential, both suspected and unsuspected.

Because the process of pharmaceutical drug discovery is long and uncertain, a central part of a drug’s suspected therapeutic potential is the drug’s prospects to treat multiple diseases. Challenges to a drug’s development may come from faster-advancing competing drugs that can become standard of care and discourage further work on other drugs. They may also come from business vagaries such as department closures in pharmaceutical companies that lead to re-alignment of internal drug portfolios. Thus, having multiple potential applications increases the likelihood that a drug will be able to navigate the development process.

The unsuspected therapeutic potential of a drug is illustrated most clearly by the field of drug repurposing. Drug repurposing has drawn attention in part due to the commercial interest of pharmaceutical companies possessing an abundance of safe drugs that have failed to show sufficient efficacy in any disease. The “poster child” of drug repurposing success is that of a safe but abandoned drug that is discovered to be efficacious with a previously unsuspected disease. While drug repurposing focuses on late-stage and post-marketed drugs, the search for unsuspected diseases for existing drugs can be undertaken at any point in a drug’s history.

Pharma Guy's insight:

A good example is Botox. Read "Botox: Pharma's Answer to Duct Tape"; http://bit.ly/botoxducktape 

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Discount Rx Drug Coupons Lower Price of Drugs, But Not How You Think They Do

Discount Rx Drug Coupons Lower Price of Drugs, But Not How You Think They Do | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Consider [Rx drug] coupons. Over the past several years, drug makers have used these to entice consumers to fill their prescriptions, since coupons defray or eliminate copay costs. In 2009, coupons were available for fewer than 100 prescription medicines, but the number exceeded 700 by last year, according to the analysis released on Tuesday by the Tufts Center for the Study of Drug Development. The study was funded by Pfizer.

 

Drug makers contend coupons help consumers who might otherwise have difficulty affording their medicines as insurance requires them to shoulder a greater share of the cost. This “can be a real barrier to patient access to medicines, and coupons can help break that barrier down,” the Pharmaceutical Research and Manufacturers of America, the industry trade group, wrote in a 2012 blog post on its web site.

 

Studies have shown, however, that coupons are a mixed bag.

 

A 2013 analysis in The New England Journal of Medicine found that 62 percent of coupons were available for brand-name drugs for which lower-cost options existed. But a 2014 study in Health Affairs found coupons reduced consumer costs for expensive specialty drugs to less than $250 a month, suggesting patients may be less likely to forego their medications.

 

Pharmacy benefit managers, which negotiate deals with drug companies and manage lists of covered medicines called formularies, argue that coupons are a ruse. As Tufts notes, pharmacy benefit managers and insurers believe coupons are increasingly used by drug makers to negate the exclusion of certain drugs from formularies, and other efforts in order to weed out less effective drugs and to lower costs.

 

So over the last few years, the nation’s two largest pharmacy benefit managers have been excluding more drugs from their formularies. CVS Caremark excluded 124 drugs in 2016, a 63 percent increase since 2014, while Express Scripts excluded 80 drugs in 2016, a 67 percent rise since 2014, according to Tufts. Significantly, coupons were available for more than 90 percent of the drugs that were excluded.

 

“The leverage gained by pharmacy benefits manager, by way of exclusions, puts downward pressure on prices of (certain) drugs,” said Joshua Cohen, a health economist at Tufts who coauthored the analysis.

Pharma Guy's insight:

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." (read "Drug Ads & Coupons"; http://bit.ly/fdacouponstudy). Also: "Rx Drug Coupons: Lower Costs at First, But You Pay More Later"; http://sco.lt/4jpt0z 

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Pfizer Blocks the Use of Its Drugs in Executions. Some States Resort to FIRING SQUADS!!!!

Pfizer Blocks the Use of Its Drugs in Executions. Some States Resort to FIRING SQUADS!!!! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical giant Pfizer announced on Friday that it had imposed sweeping controls on the distribution of its products to ensure that none are used in lethal injections, a step that closes off the last remaining open-market source of drugs used in executions.

 

More than 20 American and European drug companies have already adopted such restrictions, citing either moral or business reasons. Nonetheless, the decision from one of the world’s leading pharmaceutical manufacturers is seen as a milestone.

 

“With Pfizer’s announcement, all F.D.A.-approved manufacturers of any potential execution drug have now blocked their sale for this purpose,” said Maya Foa, who tracks drug companies for Reprieve, a London-based human rights advocacy group. “Executing states must now go underground if they want to get hold of medicines for use in lethal injection.”

 

The obstacles to lethal injection have grown in the last five years as manufacturers, seeking to avoid association with executions, have barred the sale of their products to corrections agencies. Experiments with new drugs, a series of botched executions and covert efforts to obtain lethal chemicals have mired many states in court challenges.

The mounting difficulty in obtaining lethal drugs has already caused states to furtively scramble for supplies.

 

Some states have used straw buyers or tried to import drugs from abroad that are not approved by the Food and Drug Administration, only to see them seized by federal agents. Some have covertly bought supplies from loosely regulated compounding pharmacies while others, including Arizona, Oklahoma and Ohio, have delayed executions for months or longer because of drug shortages or legal issues tied to injection procedures.

 

A few states have adopted the electric chair, firing squad or gas chamber as an alternative if lethal drugs are not available. Since Utah chooses to have a death penalty, “we have to have a means of carrying it out,” said State Representative Paul Ray as he argued last year for authorization of the firing squad.

 

 

Lawyers for condemned inmates have challenged the efforts of corrections officials to conceal how the drugs are obtained, saying this makes it impossible to know if they meet quality standards or might cause undue suffering.

 

“States are shrouding in secrecy aspects of what should be the most transparent government activity,” said Ty Alper, associate director of the death penalty clinic at the University of California, Berkeley, School of Law.

 

Before Missouri put a prisoner to death on Wednesday, for example, it refused to say in court whether the lethal barbiturate it used, pentobarbital, was produced by a compounding pharmacy or a licensed manufacturer. Akorn, the only approved company making that drug, has tried to prevent its use in executions.

 

Pfizer’s decision follows its acquisition last year of Hospira, a company that has made seven drugs used in executions including barbiturates, sedatives and agents that can cause paralysis or heart failure. Hospira had long tried to prevent diversion of its products to state prisons but had not succeeded; its products were used in a prolonged, apparently agonizing execution in Ohio in 2014, and are stockpiled by Arkansas, according to documents obtained by reporters.

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Lobbyist Argues DTC Ad Tax Deduction is as American as Cheeseburgers

Lobbyist Argues DTC Ad Tax Deduction is as American as Cheeseburgers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Limiting direct-to-consumer advertising, outright banning it, or eliminating its deduction as a business expense are not new ideas. However, a potential end to the business advertising tax deduction for DTC is more real than ever, Jim Davidson, chair of the the Advertising Tax Coalition, cautioned marketing executives.

Drugmakers can currently write off money they spend on advertising and marketing as a tax deduction. In March, Sen. Al Franken (D-MN) proposed a bill, which is called the “Protecting Americans from Drug Marketing Act,” that would end the tax deduction.

“The tax [deduction] will be one of the hardest things to defend,” Davidson told attendees at the Coalition for Healthcare Communication's Rising Leaders Conference on Healthcare Policy. He noted that tax reform will likely be a focus for the next president's agenda — a process that could begin as soon as 2017 — and added that the DTC advertising tax deduction could be seen as a major revenue offset in negotiations. Democratic candidate Hillary Clinton has said she would end tax breaks for DTC. Donald Trump has also generally expressed support for tax reform.

Colucci quipped that the pharmaceutical industry “has as much right to advertise as alcohol [companies] and McDonald's. I just want to be treated with the same respect as a damn cheeseburger.”

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#Pharma Disease Awareness Ads Scare You, Branded Drug Ads Reel You In With Calm Music

#Pharma Disease Awareness Ads Scare You, Branded Drug Ads Reel You In With Calm Music | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I [Bob Ehrlich] was a strong supporter of the Novartis heart failure disease awareness ad. This was the one with the man in the room with water pouring in and filling up the room. It was criticized by some doctors for being alarmist. I never thought so myself, as heart failure is about as serious cause for alarm as there can be.

 

 

The disease ad was a precursor to a branded ad for Entresto, which I can’t stop thinking of as Ernesto. This ad is the polar opposite in tone to the disease education campaign. While the message of preventing heart failure is the same, the branded ad takes an uplifting approach.

 

The ad uses the song from Annie, “Tomorrow” which I guarantee you will sing for at least 24 hours after seeing it. It is a series of patient vignettes where the actors sing parts of the song. The message is that Entresto will help make more tomorrows possible.

 

The disease ad really stopped you in your tracks alerting viewers that heart failure is something to watch out for and act on. While deadly serious in tone, I think it was entirely appropriate. They could have used the same idea for the branded ad but they smartly chose to play up the positives. It is better to promise in the branded campaign hope about living longer than warning about early death.

Pharma Guy's insight:

"What was necessary in the disease ad to get your attention was not the best approach in the branded ad," Ehrlich says. This seems to be a mantra of the drug industry. Boehringer, for example, produced a couple of scary, dark disease awareness videos (read "Another Dark Disease Awareness Youtube Video from Boehringer"; http://sco.lt/5WjHhx).

 

Meanwhile, Novartis hopes uplifting TV ads may sell more Entrestro (read, for example, "Tomorrow, Tomorrow, After DTC, Sales Will Come for Entresto, Bet Your Bottom Dollar!"; http://sco.lt/7L6LHl).

 

Entresto sales'll come tomorrow
Bet your bottom dollar that tomorrow there'll be sales
Just thinkin' about DTC tomorrow
Clears away the cobwebs and the sorrow till there's none
When I'm stuck with a day that's gray and lonely
I just stick out my chin and grin and say
The sales'll come tomorrow, after DTC
So you got to hang on till tomorrow, came what may!
Tomorrow, tomorrow, I love you, tomorrow
You're always a DTC ad away
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1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge!

1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen released additional data on pharmaceutical industry criminal and civil settlements, stemming from its March report tallying all settlements with both federal and state governments from 1991 through 2015. The new data provide company-specific totals for the most recent 10-year period (2006-2015), which demonstrate that, for most companies, the vast majority of penalties were paid out in those 10 years since 2006. During the 10 years from 2006-2015, 21 companies entered into two or more settlements with the federal government.

The Challenge: Can you rank the Top 10 of those companies in terms of the amount paid over those 10 years? Click on "Read More" to see how well respondents did.

Forty-three brave souls took the challenge. Only one person was able to put all the companies in the correct order.

 

Click here for more...

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Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition

Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Real fans (of intense fights over drug pricing) don't leave the stands early. The most fascinating pharma battle in recent years has been over new drugs that can rapidly cure hepatitis C (HCV). This fight has everything: Sky-high prices, congressional hearings, concerns about patient access, lawsuits, and a price war. Oh, and a mere $38 billion in combined sales since the first of these drugs launched in late 2013.  

 

In April, Gilead, the leader in this space, reported the first-ever year-over-year sales decline of its lead HCV drug. That prompted some observers to assume the frenzy had peaked -- these drugs are cures, so patient numbers should decline over time. But there are still plenty of patients who need treatment, according to a new analysis by Bloomberg Intelligence analyst Asthika Goonewardene. And a new generation of potentially quicker and more broadly effective drugs means more price wars and market-share brawls may lie ahead for Gilead and competitors such as AbbVie and Merck.

 

This status quo won't last. All three firms are working on more potent drug cocktails that could cut treatment time and work for more types of patients. As these drugs start to arrive over the next few years, things will start to get interesting.

 

BI's model takes a look at how much just one company's pricing decision on one drug -- in this case AbbVie's -- could shift billions in revenue (see chart above).

 

Scenario 1: AbbVie prices its next-generation drug at a big premium to Viekira Pak, keeping prices high across the board.

 

Scenario 2: In a second scenario, it makes that premium a little smaller.

 

Scenario 3: In a third (and probably less-likely) scenario, AbbVie prices the new drug extra-low to grab market share. A big AbbVie price cut could force Gilead to cut its own prices, and its sales could drop to $14 billion by 2018. [DISASTER!]

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Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic

Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Congress showed bipartisan support for legislation to address the nation's opioid abuse epidemic, a lawmaker urged colleagues Thursday to look closely at the role of pharmaceutical companies, citing a Los Angeles Times investigation into the manufacturer of OxyContin.

 

In remarks on the House floor, Rep. Tulsi Gabbard (D-Hawaii) called the marketing of painkillers by drug companies "the root cause of the problems."

 

She pointed to The Times investigation, which found that OxyContin, sold as a 12-hour drug, wears off early in many patients, exposing them to increased risk of addiction. Drugmaker Purdue Pharma, which has reaped $31 billion from the painkiller, had evidence of the duration problem for decades, but continued telling doctors it lasted 12 hours, in part to preserve revenues, The Times found.

 

"The problems created by companies like Purdue are felt deeply by families all across our country," said Gabbard, an Iraq war veteran who has endorsed Democratic presidential candidate Bernie Sanders.

 

"Opioid abuse and addiction is one of our top national health challenges, and that's why for more than a decade Purdue Pharma has undertaken efforts to help address this crisis," the company said.

 

[Meanwhile, Purdue also said it “looks forward” to appealing a Kentucky court ruling to release secret documents about the marketing of the potent pain pill OxyContin (read “Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!”; http://sco.lt/4kfBNB)]

 

"We've seen for decades that major pharmaceutical companies have misled the FDA, doctors and patients about the safety and risks of opioid dependency … in their efforts to sell more drugs," Gabbard said.

 

Her remarks came as the House passed a bundle of bills to stem the opioid crisis. More than a dozen drug-related bills approved this week parallel similar legislation advanced in the Senate. In both chambers, the legislative effort has garnered bipartisan support. Congressional Republicans, particularly lawmakers facing tough reelection fights this fall, have trumpeted their response to the epidemic.

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Shire to Defend Its Binge Eating Disorder Screener at 2016 APA Annual Meeting

Shire to Defend Its Binge Eating Disorder Screener at 2016 APA Annual Meeting | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire will present new research on Binge Eating Disorder (B.E.D.) and Attention-Deficit/Hyperactivity Disorder (ADHD) at the upcoming 169th Annual Meeting of the American Psychiatric Association (APA) in Atlanta, GA, demonstrating its ongoing commitment to furthering the understanding and management of psychiatric disorders.

 

“The data being presented this year at APA will address several important topics within the adult psychiatry therapeutic area, including the characterization of eating behaviors in adults with binge eating disorder, as well as patterns of prescription medication use in two psychiatric disorders,” said Barry K. Herman, MD, MMM, DLFAPA, Global Medical Team Lead, Senior Medical Director for Shire. “These presentations underscore our long-standing commitment to furthering knowledge of psychiatric conditions and advancing research into the unmet needs of people with B.E.D. and ADHD.”

 

Posters presented during the conference will include:

 

Poster Number P6-048; Monday, May 16, 2:00pm EDT: The Use and Value of the 7-Item Binge Eating Disorder Screener in Clinical Practice; Presented by Barry K. Herman, MD, MMM, DLFAPA

 

“Continued research on binge eating disorder in adults is crucial to expanding our understanding of the disorder,” said Cynthia Bulik, PhD, FAED, Distinguished Professor of Eating Disorders, Department of Psychiatry, University of North Carolina at Chapel Hill, and co-author of P6-136. “We value our collaboration with Shire to enhance efforts to educate health care professionals who evaluate adults living with B.E.D.”

Pharma Guy's insight:

Shire makes it easy for anyone to convince their docs to prescribe Vyvanse for their B.E.D. (Binge Eating Disorder), which I described in Pharma Marketing Blog: "How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse"

 

Shire's B.E.D. symptom checklist, IMHO, is a perfect aid for people who wish to abuse a dangerous Schedule II controlled stimulant.

 

According to my more or less truthful answers to the screener, I may suffer from B.E.D. and be able to convince my doc to prescribe me Vyvanse. 

 

I suggested (http://bit.ly/BEDchecklist) that Shire remove this tool from its website to prevent possible abuse of this medication, but now I see Shire wants to "prove" to the medical community that this bogus test has value in clinical practice!

 

"The strategy for a new drug to treat binge-eating disorder reveals how a pharmaceutical company can influence the treatment of a medical condition," said Dr. Lawrence H. Diller, a behavioral pediatrician in Walnut Creek, Calif. Read: "Shire Makes It Easy for the Public to Learn About the ‘Glories of Amphetamine’"; http://sco.lt/7xiqtl 

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Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!

Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Secret documents about the marketing of the potent pain pill OxyContin will be unsealed next month under an order issued Wednesday by a Kentucky judge.

STAT filed a motion in March to unseal the records in Pike Circuit Court in Kentucky. They include the deposition of Dr. Richard Sackler, a former president of OxyContin maker Purdue Pharma and a member of the family that owns the privately held Connecticut company.

OxyContin has been blamed by many for helping to ignite the scourge of opioid abuse in the United States that began with prescription painkillers and has progressed to heroin and fentanyl.

“The court sees no higher value than the public (via the media) having access to these discovery materials so that the public can see the facts for themselves,” Judge Steven Combs said in his ruling.

He ordered that the documents be unsealed in 32 days, which would be June 12. He said he would stay the release of the records if any party files an appeal before then.

 

“The national opioid epidemic is killing 30,000 people a year, and we are pleased that the court moved so swiftly to bring to light records that can inform the public’s understanding of Purdue’s role in this crisis,” said Rick Berke, STAT’s executive editor. “We see pursuit of this story as integral to STAT’s central mission to hold institutions and individuals accountable.”

Purdue’s chief litigation counsel, Richard Silbert, said in a statement, “We look forward to appealing this ruling.”

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Are Pharma Drug Ads Better or Worse With Celebrity Endorsers? Some Rules to Apply.

Are Pharma Drug Ads Better or Worse With Celebrity Endorsers? Some Rules to Apply. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Signing celebrities to market a drug can be like playing with fire, as some companies know well. But there are things drugmakers can do to minimize risk and get the most from their celeb endorsers, marketing experts say.

 

Before a company even considers using celebs in their direct-to-consumer ads, they need to have a great idea, Howard Courtemanche, CEO of pharma marketing company J. Walter Thompson Health, told an audience at the recent DTC National Conference in Boston. Then, a drugmaker should implement the “minus one, multiply by 20 rule" to see if the celeb is the right fit.

 

“Will that idea be less, or minus one, without a celebrity? That’s the first gut check," Courtemanche said. "The second check is, if you have a celebrity at hand, are there 20 other celebrities that could do the job just as well? Then you realize that you don’t have the right celebrity," Courtemanche said.

 

Sometimes companies run into problems once a campaign has launched. For a prime example, look no further than Duchesnay’s marketing debacle last summer after celebutante Kim Kardashian endorsed its morning sickness med on Instagram. The Canadian pharma was forced to pull its ads and run a correction after the FDA sent it a scathing warning letter.

 

“Most brands do an excellent job working with celebrities. There is a happy ending.”

 

[Bada Bing!]

Pharma Guy's insight:

I like the "Happy Ending" quote at the end of this story :)

 

One rule or test this advice from a marketing company does not mention is if the endorsement passes the "authenticity smell test." For more on that read this: http://sco.lt/7FpJwH 

 

Kim Kardashian dis NOT pass this test. But she was not the most egregious pharma celebrity endorser. That distinction had to go to Paula Deen who, "yes, of course" used the "N" word. See my Gallery of Favorite Drug Ad Celebrities: http://bit.ly/pgfavoritecelebs 

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Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV

Khloé Kardashian Shills for Kybella at Dermatologists' Offices & Soon on TV | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Kybella, Allergan’s med for excess chin fat, is already in the middle of a successful launch. But the company is by no means stopping there, execs said Tuesday.

 

So far, the Dublin drugmaker has trained more than 4,000 providers to inject the drug--in other words, nearly half the product’s potential user base, commercial chief Bill Meury told investors on the company’s Q1 conference call. And of those trainees, 3,000 have already placed orders for the fat-fighter.

 

But Allergan knows it’s up to its own marketing ranks to lay “the groundwork in the creation and development of this new market for injectables,” Meury said--and so it plans to keep the push going strong. Later this year, the company will roll out a DTC campaign for Kybella, which will follow up on marketing activities that have included a partnership with Khloé Kardashian.

Pharma Guy's insight:

I knew a Kardashian was going to shill for Allergans "chin" buster drug (read "Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face"; http://sco.lt/8osXGD). But I thought it would be Kim and her fat ass as in this Kybella FAQ:

 

Could the drug help destroy fat cells in other areas of the body?

Like Kim Kardashian's ass?

 

BTW, Khloé easily competes with her sister ass-size-wise!

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Top Capitalists Tell #Pharma Leaders to Better Defend High Drug Prices b4 Lawmakers Act

Top Capitalists Tell #Pharma Leaders to Better Defend High Drug Prices b4 Lawmakers Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A group of major U.S. investors, spooked by the recent slump in biotech shares amid political bashing of drug prices, met with a lobbying group and executives last month to urge them to do a better job in defending their industry and take control of the conversation before lawmakers try to regulate prices.


Representatives from Fidelity Investments, T. Rowe Price Group Inc. and Wellington Management Co. -- which all invest about a fifth or more of their U.S. stock holdings in health care -- were among those at the meeting, held at a Boston hotel, according to people familiar with the matter who asked not to be identified because the meeting wasn’t public.


“Biotech lives and dies on investors being willing to put money at risk for long periods of time,” said Ron Cohen, board chair of Biotechnology Innovation Organization, an industry group known as BIO, who attended the meeting. BIO is now mobilizing to take a more prominent stance on drug pricing, he said, fearing shareholders will flee the sector: “Ninety percent of companies fail, and investors are putting hundreds of millions of dollars over 10 to 15 years -- they have to believe that if they win, they win big.”


Cohen said officials from six or seven funds were present at the meeting, declining to identify them. Jim Greenwood, chief executive of Washington-based BIO, also attended. So did George Scangos, the chief executive of Cambridge,

Massachusetts-based Biogen Inc., according to the people.
Representatives for Fidelity, T. Rowe and Wellington declined to comment. A representative for Scangos at Biogen also declined to comment. Scangos is also chairman of the board of industry organization Pharmaceutical Research and Manufacturers of America, or PhRMA. A spokesman for PhRMA said he didn’t attend on behalf of the organization.

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