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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It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare

It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare | Pharmaguy's Insights Into Drug Industry News | Scoop.it

My hope is that Silicon Valley and entrepreneurs nationwide will collaborate on building an environment capable of linking the more than 300 million people in the U.S. to information that helps them live healthy, productive lives. Within this broad mission, I’m particularly focused on bridging a growing divide that has led to unprecedented health disparities as functions of income, education, race, and geography. But as increasingly ubiquitous smartphones and other electronic devices allow more and more people to access amazing sources of information and knowledge, we have the essential means to reverse these trends.


Both giant information companies and our country’s universities—particularly those with large health systems—have critical roles to play in ensuring that all Americans, and ultimately the entire world, benefit from new knowledge and technological capabilities. Generating and analyzing information are not enough—we must overcome barriers to using data to improve health and healthcare. I have no illusion that I have the solutions to these problems, but I am grateful for the opportunity to work with a company and a university that are letting me give it a shot!

 

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Republican Maneuver May Clear the Way for Califf Approval for Top FDA Job

Republican Maneuver May Clear the Way for Califf Approval for Top FDA Job | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him.


The move will likely vanquish the remaining senators — led by Democrats Bernie Sanders of Vermont, Edward Markey of Massachusetts, and Joe Manchin of West Virginia — who disapprove of Califf because of his close ties to industry and what they consider a poor FDA response to the opioid epidemic.

 

Califf joined the FDA as a deputy commissioner in February 2015 after many years working at Duke University.


Pharma Guy's insight:

When Califf assumes the position of FDA Commish, will he be like to back a plan by his former Duke colleagues and implement their plan to open the off-label drug promotion floodgates? For more on that, read "Duke Chimes in on Off-Label Drug Promotion"; http://bit.ly/dukeofflabel 

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Senate Committee Clears Califf But Bernie Sanders May Throw Shoe

Senate Committee Clears Califf But Bernie Sanders May Throw Shoe | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.


The Senate Health, Education, Labor and Pensions Committee on Tuesday voted unanimously in favor of Dr. Robert Califf to become commissioner of the FDA. Two senators have threatened to block the former Duke cardiologist's nomination, however. 


Sen. Lisa Murkowski (R-Ala.) said she would hold up a vote on the Senate floor, the next and final step in Califf's nomination, until the FDA addresses her concerns about the labeling of genetically modified salmon. 


Sen. Bernie Sanders(I-Vt.), too, opposes the nomination and is considering a hold—he has cited Califf's ties to the pharmaceutical industry, particularly his work as a consultant for drugmakers. Sanders was not present at the committee hearing. Open Payments data show that Califf received over $29,000 in consulting fees, food and travel from drugmakers in 2014.

Pharma Guy's insight:

Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


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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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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NYT Has Questions for President Obama’s Nominee to lead the F.D.A.

NYT Has Questions for President Obama’s Nominee to lead the F.D.A. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Obama’s nominee to lead the Food and Drug Administration has a long history of close ties to industries the agency regulates. At Dr. Robert Califf’s confirmation hearing on Tuesday, senators will need to ask whether those connections will influence his judgment about the safety or effectiveness of prescription drugs.


In recent years, the F.D.A. has approved two diet drugs that European regulators have deemed too risky, leaving the impression that it gives in to industry demands over safety. A new commissioner must be strong enough to protect the agency against such pressure from industry and from members of Congress who believe the approval process for drugs and devices should allow faster approvals with less scientific evidence.


Dr. Califf had a distinguished career as a cardiologist and clinical researcher at the Duke University Medical Center from 1982 to 2015 before he joined the F.D.A. early this year as a deputy commissioner. His nomination has been supported by medical organizations, including the American Academy of Pediatrics and the American Association for Cancer Research, which believe that he will find ways to make drugs more effective, safer and cheaper.


On Thursday, the Project on Government Oversight, an advocacy group, reminded the public that Dr. Califf helped design and oversee a clinical trial of a blood thinner, Xarelto, made by Johnson & Johnson, and argued for its approval. The F.D.A. approved the drug in 2011, even though its primary reviewers had objected, saying design and execution flaws biased the trial in favor of the drug. In 2012, Johnson & Johnson paid Dr. Califf $87,500. Twenty percent of it was a management fee; the rest was for his consulting, and he donated that to charity.


In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a “barrier” to biomedical innovation. The senators need to press him on whether he plans to modify or even weaken regulations to make them less of a barrier.


“Senator Bernie Sanders of Vermont, a member of the committee, has opposed the nomination because he considers Dr. Califf’s ties to industry too broad and deep. He is concerned that Dr. Califf would do little to help reduce the high prices of some drugs by, for example, allowing cheaper versions of the drugs to be imported from other advanced nations.”


Dr. Califf’s task is to show that he will be able to guard the public interest and resist industry pressures.

Pharma Guy's insight:
President Obama’s nominee to lead the Food and Drug Administration recently coauthored a series of scientific papers but asked that his name be removed before publication.


Dr. Robert Califf, the Duke cardiologist first named a deputy commissioner in January and then nominated for the top post last month, was the driving force behind the series, which was published in the October issue of the journal Clinical Trials.

The heart of the series is an examination of what are known as pragmatic clinical trials — an increasingly popular type of study that seeks to compare two or more treatments in a real-world setting instead of in a traditional clinical environment. Portions of the papers are critical of the agency and recommend policy changes that would be highly divisive.
Link to more: http://sco.lt/8dwRer 
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Califf Is Not the Person to Lead FDA, Says Bernie Sanders

Califf Is Not the Person to Lead FDA, Says Bernie Sanders | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said after speaking with the nominee. Califf’s confirmation will come before the Senate health committee, which Sanders sits on.

Pharma Guy's insight:

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. http://bit.ly/1L3DUno 

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The FDA Now Officially Belongs to Big Pharma

The FDA Now Officially Belongs to Big Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved today as the next FDA commissioner. Vocal opponent Bernie Sanders condemned the vote from the campaign trail. But where was Dick Durbin? Where were all the lawmakers who say they care about industry and Wall Street profiteers making money at the expense of public health?


Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.


Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.


In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?


Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?


He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)


Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Xarelto's serious and foreseeable risks were back in the news this week.


Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a "60 Minutes" special. It is the least appropriate place from which to choose an FDA commissioner.

Pharma Guy's insight:

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3 

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Pharma Guy's curator insight, March 28, 2016 8:05 AM

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3 

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Another Senator Vows to Block Califf Nomination for #FDA Commish

Another Senator Vows to Block Califf Nomination for #FDA Commish | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Yet another senator throws a shoe at Robert Califf, the shoo-in candidate for FDA Commissioner.


Sen. Edward Markey (D-Mass.) says he's blocking the nomination of Dr. Robert Califf to be commissioner of the Food and Drug Administration until the agency makes reforms to its approval process for opioid painkillers.


Markey said Monday he put a hold on Califf, whose nomination cleared the Senate Health Committee earlier this month and was headed to the floor for a vote.


Markey is upset with the FDA’s decision last year to approve the use of OxyContin to treat children as young as 11 years old. He called on the agency to commit to holding advisory committees before approving such painkillers in the future.


“While people in every community across the country are dying every day from opioid overdoses, the FDA continues to operate as if safety just means the right dose when it should include all the dangers of these painkillers,” he said in a statement.


“Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs.

Pharma Guy's insight:

Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


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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Califf a "Shoe-in" to be Approved for FDA Commish

Califf a "Shoe-in" to be Approved for FDA Commish | Pharmaguy's Insights Into Drug Industry News | Scoop.it
He has been trying to satisfy Democratic concerns that he's too close to pharmaceutical companies.


He has had to spend time addressing concerns from Democratic committee members — especially Senator Bernie Sanders of Vermont, the presidential candidate, and Senator Elizabeth Warren of Massachusetts. They’ve grilled Califf on his close ties to pharmaceutical companies and the impact of their funding on research he oversaw at Duke. Sanders, who has been out on the campaign trail, isn’t expected to show up for the vote.


In written responses to follow-up questions from Warren, Califf said he and his Duke Center did not permit its pharmaceutical industry funders to influence the outcome of the studies — although he acknowledged their input into the design.


Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


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

 

Pharma Guy's insight:

Remember when FDA Commissioner Andrew von Eschenbach was announced that he planned to resign as FDA commish in 2009? A disgruntled FDA staffer rose abruptly from his seat about 12 feet away, reared his right arm and fired a shoe at the commissioner’s head while shouting: “This is a gift from the entire FDA staff; this is the farewell kiss, you dog!”; http://bit.ly/1E74Dv 

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Bernie Sanders to Robert Califf: "You're Not the One."

Bernie Sanders to Robert Califf: "You're Not the One." | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Under sharp questioning from Democratic Senator Elizabeth Warren of Massachusetts, Califf promised to strike the right balance between approving new drugs quickly and making sure they’re safe.


“I think if you look at my record, I’ve never been a proponent of lowering standards. If anything, I’ve argued for raising them,” he told Warren. “That doesn’t mean we couldn’t be quicker in some cases.”


But Sanders — who had previously announced he wouldn’t support Califf — grilled the potential FDA commissioner in an unsuccessful attempt to get him to support reimportation of cheaper prescription drugs from other countries and allowing Medicare to negotiate lower drug prices, two key proposals in Sanders’ plan to rein in drug costs.


“We all want great medicines to come onto the market, and I respect the work you have done. But at the end of the day, people are dying … because we have been extraordinarily weak in taking on the pharmaceutical industry,” Sanders told Califf. “I believe we need a commissioner who is going to stand up to the pharmaceutical industry, so I have to say to you with regret you are not that person.”


Most of the questions Califf received from Republicans and Democrats on the committee were polite and restrained, and he’s still expected to win confirmation. But his past financial support from the pharmaceutical industry quickly became the running theme of the questions from Democratic senators.

Pharma Guy's insight:

Sanders also brought up other issues that prevent the U.S. from lowering drug prices; e.g., pharma lobbying (In 2014, the pharmaceutical industry spent $250 million on lobbying and campaign contributions and employed some 1,400 lobbyists. “Do you think that type of expenditure has any impact on the fact that we pay the highest prices in the world for prescription drugs?” Sanders asked Califf.) and Medicare's inability to negotiate lower drug prices (see here: http://sco.lt/7igOmn). Listen to the hearing here: http://1.usa.gov/1MQk01x 

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Califf Removes His Name as Author of Scientific Paper Critical of FDA

Califf Removes His Name as Author of Scientific Paper Critical of FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it
President Obama’s nominee to lead the Food and Drug Administration recently coauthored a series of scientific papers but asked that his name be removed before publication.


Dr. Robert Califf, the Duke cardiologist first named a deputy commissioner in January and then nominated for the top post last month, was the driving force behind the series, which was published in the October issue of the journal Clinical Trials.


The heart of the series is an examination of what are known as pragmatic clinical trials — an increasingly popular type of study that seeks to compare two or more treatments in a real-world setting instead of in a traditional clinical environment. Portions of the papers are critical of the agency and recommend policy changes that would be highly divisive.

It’s unclear what prompted Califf to remove his name — a decision that could raise ethical concerns. It is highly unusual for authors of scientific papers to have their names removed before publication.


A spokeswoman for Califf said he declined to comment. A coauthor on one paper, speaking on condition of anonymity because of the sensitivity of the matter, said Califf had been told to mask his authorship by the FDA.

 

A spokeswoman for the agency suggested it was his decision.


One of the papers — which focus largely on clinical trials and deal only partially with the FDA and regulation — coauthored by Califf pushes back against skepticism.


“We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products,” the paper says.


Another passage from that article discusses ways to make it easier for researchers to gain consent from study participants — a process critics say has become too cumbersome and confusing for potential enrollees. “We believe that the FDA should have the explicit authority to consider alteration or waiver of individual informed consent when deemed appropriate,” the article notes.

Pharma Guy's insight:

Wow! Waiving informed consent! I've got to read more about that! The removal of his name from scientific papers could complicate his hearing before the Senate. And one member of the Senate committee that will question Califf before nomination is Bernie Sanders who already has proclaimed that Califf is not the person to lead the FDA. See http://sco.lt/8vR2kD 

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