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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Bayer/Janssen’s Xarelto COMPASS Trial Stopped Early - "Superior" to Aspirin But Without the Safety Profile

Bayer/Janssen’s Xarelto COMPASS Trial Stopped Early - "Superior" to Aspirin But Without the Safety Profile | Pharmaguy's Insights Into Drug Industry News |

Bayer/Janssen's bloodthinner Xarelto has shown clear efficacy in preventing major cardiovascular events (MACE) in patients with coronary or peripheral artery disease taking part in the COMPASS trial, prompting an early halt to the late-stage study.


The 27,000-plus patient trial was scheduled to finish next year but has been stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE - including cardiovascular death, myocardial infarction and stroke - reached its pre-specified criteria for superiority versus aspirin.


Given the magnitude of the drug's effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the study, said they will offer Xarelto (rivaroxaban) to study participants in an open-label extension trial.


"Despite established and effective treatments, incidences of CAD and PAD are rising globally," said Paul Burton, vice president, Medical Affairs, Janssen. "We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the US Food and Drug Administration as quickly as possible."

Pharma Guys insight:

This article, which appears to be lifted directly from a press release, does not mention any of Xarelto's side effects. Johnson and Johnson and Bayer Corp. are being sued based on allegations that they deliberately concealed the blood thinner Xarelto potential fatal side effect of internal bleeding:  Meanwhile, AMA chastised lawyers for revealing Xarelto's side effects in TV Ads: 

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UK Patient Groups that Backed New Cancer Drug Received £ from #Pharma Firm

UK Patient Groups that Backed New Cancer Drug Received £ from #Pharma Firm | Pharmaguy's Insights Into Drug Industry News |

Three patient groups that successfully lobbied for a new leukaemia drug to be on the NHS received over £60,000 from the pharma firm behind the product.


One of the charities relies on Big Pharma for 70 per cent of its funding and has a trustee with financial links to Janssen-Cilag, which manufactures the Ibrutinib drug. Leukaemia Care, the Chronic Lymphocytic Leukaemia Support Association (CLLSA) and Bloodwise made formal submissions in relation to the capsules.


Janssen-Cilag provided the CLLSA with a £20,000 grant in 2104 for “summits”, “video materials”, “surveys” and “conferences”.


The patient group’s latest accounts state: “Main source of funds are from members donations and grants from pharmaceutical companies.”


Charity chair David Innes denied the CLLSA had a conflict of interest: “All our relations with pharmaceutical companies are regulated by the code of the ABPI. This code specifically rules out any interference in our affairs by any pharma company.”


However, professor David Miller, an academic who is also a transparency campaigner, said the practice of healthcare giants funding these groups “distorts” the decision-making process.

Pharma Guys insight:

Although there may be no visible "strings" attached to such grants, if the patient group is deemed not to have reciprocated by supporting the donor's cause, there may be no future "hands off" funding.


In any case, It’s good to know that patient groups in UK may be as influenced by pharma money as those in the U.S. For more on that, read: “Majority of Patients’ Groups Siding With Pharma Against Medicare Part B Pricing Reforms Receive Industry Funding”;

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One Step Closer to Universal Flu Vaccine. Yay! I was there!

One Step Closer to Universal Flu Vaccine. Yay! I was there! | Pharmaguy's Insights Into Drug Industry News |

Researchers in the US have started testing what they believe could be a universal vaccine against influenza, tackling both seasonal and pandemic strains such as bird flu.

The team - from the Scripps Research Institute (TSRI) in the US and Johnson & Johnson's Janssen Pharma unit - say the vaccine could provide long-acting protection against seasonal flu, potentially doing away with the need to develop new vaccine cocktails every year to address the prevailing strains.

The ultimate aim is to have a vaccine that only has to be given every five to 10 years to protect against flu, and would also provide some protection against emerging pandemic strains.

That would include those that jump the species barrier from animals to humans, such as the swine flu epidemic that killed hundreds of thousands of people worldwide in 2009.

The work is still in animal studies but focuses on using a different part of the flu virus as the basis for the antigen used in the vaccine. 

At the moment, scientists analyse the flu surface protein hemagglutinin (HA) in circulating flu strains to guess which will be causing infections during the flu season and setting in motion a manufacturing scramble to make combination vaccines that can take several months.

If the virus changes in the interim, the vaccine will be less effective. That happened last year, where the engineered vaccines only cut the chance of developing flu by around 23%. To compensate, pharma companies are developing vaccines that increase the number of strains included in the cocktail from three to four.

In a bid to sidestep that arms race, the TSRI and Janssen researchers are working with the stem of the HA protein, rather than the top end which is variable.

Pharma Guys insight:

Regarding my involvement: I once made a living building molecular models of complex proteins for life science researchers. One such model was of the influenza flu coat protein, which I built for  Dr. Ian Wilson, who is now Chairman of the Department of Integrative Structural and Computational Biology at The Skaggs Institute for Chemical Biology, which is part of the Scripps Research Institute. The model is still on display in the lobby of the Scripps Research Institute! Below is a recent photograph that was sent to me by Mika Elizabeth Ono, Scripps Research Institute Director of Communications.

Back in the 80s, when I built this model, computer graphics were not good enough to help scientists like Wilson visualize the detailed structure of proteins. Here's how Dr. Wilson describes my tiny contribution to his research:

"We decided we would have a go at building a trimer so we co-opted John Mack from New York who was a model builder. He came up to Harvard [I built a model there first] and we constructed a dimer as one unit. This was a three-dimensional plastic model, 1 angstrom per cm. We could actually look at this thing to see what it really looked like and we could obviously trace it out. There were some limited computer-graphics programs that you could use to trace out the molecule, but it was really hard to get a feel for what it was all like without seeing everything at once. So that (three-dimensional) model turned out to be extraordinarily useful for trying to understand the structure. The third monomer was also built and we thought we would be able to assemble and disassemble the trimer, but they were so intertwined that it was impossible" (see "A Discussion with Ian Wilson").

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FDA Dialogues With Diabetes Patients at Live Gathering & Online Via #DOCasksFDA Twitter Chat

FDA Dialogues With Diabetes Patients at Live Gathering & Online Via #DOCasksFDA Twitter Chat | Pharmaguy's Insights Into Drug Industry News |

By Manny Hernandez

This past Monday, was the historical the FDA-Patient Dialogue on Unmet Needs in Diabetes. I had the honor to be a part of a diverse and wonderful panel of patients aimed at bringing some perspective into elements of our lives with diabetes are still not adequately addressed by the agency.

Social media was buzzing with enthusiasm using the #DOCasksFDA hashtag (DOC = Diabetes Online Community). You can get a really good sense of that day on Twitter thanks to this comprehensive Storify that the folks at diaTribe Foundation put together. In fact, enthusiasm seems to have exceeded FDA's wildest expectations in terms of attendance, since the webcast system crashed halfway through the 3-hour long event.

Yet much was accomplished during the day. First off, the crash signaled to me the level of interest the community has to work together with the FDA, and that is a GREAT thing! Also, I felt that the agency showed us that they are truly listening, as Brian (another patient advocate in the meeting) pointed out on this post he wrote on TuDiabetes.

Pharma Guys insight:

Manny Hernandez is president of the Diabetes Hands Foundation, which sponsors -- along with Janssen Pharmaceuticals -- the annual Big Blue Test, a program that runs from October 20 to November 19, concluding shortly after World Diabetes Day on November 14. For more about that, read Janssen Pharmaceuticals and Diabetes Hands Foundation Encourage People with Type 2 Diabetes to Get Moving for National Diabetes Month


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Want a $500 K Grant? Enter J&J's World Without Disease QuickFire Challenge

At Johnson & Johnson Innovation and Janssen Research & Development, our goal is to improve the health and wellness of people around the world. To that end, we have a passionate and engaged workforce across our consumer, medical device and pharmaceutical units who are interested in finding and deploying comprehensive, end to end, integrated solutions which take into account the world in which we live today. Johnson & Johnson Innovation and Janssen Research & Development are bringing together the consumer, medical device and pharmaceutical sectors to award a prize or a series of prizes to the person or team(s) who submits the best idea, technology, or solution that will address a critical health need for the world's population.

Pharma Guys insight:

Laudable. I know this is marketing speak, but a world without disease is as realistic as a world without war, IMHO.


Also read: "Johnson & Johnson Expands Its Membership in the Digital Innovation Club"; 

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Pharma Marketing Blog: Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent?

Pharma Marketing Blog: Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent? | Pharmaguy's Insights Into Drug Industry News |

On, David Palacios, Head of Global Patient Relations, and Sanja Njegic, Head of Patient Advocacy & Relations in Europe at Novartis, explain how their company has moved from working with doctors and payers to working directly with patients. The interview was recorded at Eyeforpharma Barcelona 2016.

“We developed last year what we call the 'patient declaration,' which is a public statement about what patients can expect from us,” said Palacios. “It is an internal and external commitment. By having this document everybody in the company needs to work seriously to honor what we said in the patient declaration. That has triggered a lot of discussion internally.”

Some of that discussion must have been around "transparency" with regard to compensating patients -- especially patient bloggers and patient advocates -- for their opinion, much like pharma has traditionally paid physician Key Opinion Leaders (KOLs) for their opinions. Did that discussion result in any relevant disclosure in the "patient declaration?


Find out here.

Pharma Guy's curator insight, July 23, 2016 9:40 AM

Back in 2013, the U.S. Justice Department  filed a civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers (read the details here).

DOJ claims that Novartis violated the Anti-Kickback Statute by paying doctors to speak about certain drugs, including its hypertension drugs Lotrel and Valturna and its diabetes drug Starlix, at events that were often little or nothing more than social occasions for the doctors. 

Many speaker programs were held in circumstances in which it would have been "virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast," the suit claims.

"Other Novartis events were held at Hooters restaurants."


Read "Novartis Wines -- er, Beers -- and Dines Docs at Hooters!";

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"Janssen Followed All Rules," Yet Has Paid Billions of $ to DOJ for Illegal Risperdal Marketing

"Janssen Followed All Rules," Yet Has Paid Billions of $ to DOJ for Illegal Risperdal Marketing | Pharmaguy's Insights Into Drug Industry News |

David Kessler, the former U.S. Food and Drug Administration commissioner, testified Wednesday that as a pediatrician, it "certainly is a red flag to me" that a Janssen Pharmaceuticals Inc. study of the use of its antipsychotic drug Risperdal in young children and adolescents, mainly boys, showed high rates of breast growth.

Kessler was FDA commissioner from 1990 to 1997, when Janssen, a subsidiary of Johnson & Johnson, received approval in 1993 for the drug to be prescribed to adults with psychosis. In the ensuing years, Janssen sought to expand the approved uses and the range of patients.

Kessler testified in Philadelphia Common Pleas Court as a witness for two Alabama parents who sued Janssen because their severely autistic son, now 20, was prescribed Risperdal for the first time when he was about 7½, without their fully knowing its risks. The boy developed breasts, a condition called gynecomastia.

Not until 2006 was Risperdal approved for use in autistic adolescents. By then, the boy had been on Risperdal for five years. Janssen sales reps had visited his pediatric neurologist, Jan Mathisen, 20 times between 2002 and 2004, bringing samples.

Testifying Monday, Mathisen said he had been the most frequent prescriber of Risperdal in Alabama. He said he would have liked to have known about the Janssen study.

"Janssen followed all rules for reporting data from clinical trials, and we believe that the prescribing information for Risperdal has been appropriate at all times," Janssen spokeswoman Robyn Reed Frenze said in a statement.

Pharma Guys insight:

Read: How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine

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