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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#Pharma 'Highjacks' Public Comments at FDA Advisory Meetings

#Pharma 'Highjacks' Public Comments at FDA Advisory Meetings | Pharmaguy's Insights Into Drug Industry News | Scoop.it

About one-third of "public" speakers at US Food and Drug Administration (FDA) advisory committee meetings on yet-to-be-approved cancer drugs in recent years had financial ties to the pharmaceutical industry, according to new research.


In other words, public testimony, which is mostly from patients and the staff of nonprofits, and can be emotionally compelling, is regularly supported by private interests.


"The industry has hijacked that microphone; they're using it as their second presentation at advisory committee meetings," senior study author Vinay Prasad, MD, MPHfrom the Oregon Health Sciences University in Portland, said in a press statement about the findings, which were published onlineFebruary 1 as a research letter in JAMA Internal Medicine.


Dr Prasad's strong words are based on the study, which looked at all 103 public speakers at 28 meetings of the FDA Oncologic Drugs Advisory Committee (ODAC) from 2009 to 2014. The committee's recommendations are usually followed by the FDA.


The agenda at an ODAC meeting includes presentations from a drug company and the FDA itself, plus public comment.


Public comment at ODAC was overwhelmingly in favor of the drugs under discussion, the study indicates: 95 of the 103 (92%) speakers supported marketing approval; only six (5.8%) speakers did not (two were neutral).


This occurred even though ODAC meetings are typically reserved for drugs "where the risk–benefit [ratio] is even more questionable than usual," Dr Prasad explained.


Notably, 31 (30%) of the public speakers reported financial ties to the drug maker, including financial support for travel to the FDA meeting or broader organizational support.


This is unfair, Dr Prasad suggested. "The industry already gets a chance to make its case at ODACs. In my mind, any percentage more than 0% is too high," he told Medscape Medical News about the proportion of industry-supported public comment.

Pharma Guy's insight:

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"


FDA should add to its list of "Yes" questions: "Do you have financial ties to the drug industry?"

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Pharma Guy's curator insight, March 30, 2016 1:54 PM

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"

 

FDA should add to its list of "Yes" questions: "Do you have financial ties to the drug industry?"

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High Prescribing Docs Get More Sunshine ($) from #Pharma

High Prescribing Docs Get More Sunshine ($) from #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Using data from the Medicare Prescription Drug Program (Part D) and the Open Paymentsprogram, HealthGrove examined doctor prescribing rates for all of 2013 and pharmaceutical payments data from August to December of 2013. Within this data, a pattern emerges: doctors who prescribe a lot of drugs tend to get more money from pharmaceutical companies. Adjusting by physician specialty, the higher the doctor prescribing rate, the stronger the chance she receives pharmaceutical industry payments.


To categorize “high-prescribing” doctors, we looked at prescribing rates within the various specialities and grouped physicians into percentiles. The highest prescribers fell above the 80th percentile in either claim counts or claim costs per patient. Whether a doctor is writing more prescriptions per patient (claim count) or writing more expensive prescriptions per patient (claim cost), the trend remains the same.


The first tab, ranking prescription counts per patient, shows that 45.3 percent of the highest prescribing doctors (above the 80th percentile) received payments from the pharmaceutical industry, with the average payment totaling $146 per physician. On the other hand, only 21.4 percent of the lowest-prescribing doctors (those below the 20th percentile) received industry payments. And, if they did, the average payment was only $89. High prescribing doctors were not only more likely to receive payments from pharmaceutical companies, but these payments were also larger, on average.

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HHS Transparency Reforms Not More Effective in Uncovering Conflicts of Interest

HHS Transparency Reforms Not More Effective in Uncovering Conflicts of Interest | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Relationships between industry and researchers can be hard to define, but universities and other institutions must do more to scrutinize the work of their scientists for conflicts of interest.


In trying to navigate such complexities, the US National Institutes of Health (NIH) has been ahead of the curve — presumably because of long-standing concerns about physicians’ industry relationships and the high stakes for protecting patients. Its parent agency, the Department of Health and Human Services (HHS), was the first to establish conflict-of-interest disclosure rules in 1995 and is still beyond many of its counterparts in maintaining unified regulations that include yearly reports to the government. By contrast, as one example, the US National Science Foundation’s grants policy suggests that institutions look to scientific societies for ideas on how to manage a conflict of interest, and to report back to the foundation only if institutions cannot handle it themselves.


But even the HHS rules were not enough to guarantee full transparency. In 2009, a congressional report and subsequent media coverage found that some NIH-funded researchers had quietly accepted millions of dollars from industry. Again, the blame kept shifting: the universities said that the researchers had not reported the conflicts, the NIH received only bare-bones reports from institutions, and the researchers said that they did not know they were breaking any rules.


The HHS updated its policies in 2011, but pleased no one. The government underestimated the time and money that institutions would spend implementing new rules. And some aspects of the reforms have proved to be window dressing: a Nature investigation this week reveals that these reforms have uncovered few conflicts of interest that would have escaped the original regulations.


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Pharma Guy's insight:

You might also be interested in reading this Pharma Marketing Blog post: "In Medical Publishing, Is Disclosure Enough?"; http://bit.ly/scIp4 

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Medical Journals Serve as Big Pharma Drug-Marketing Platform: Study by COI "Enabler"

Medical Journals Serve as Big Pharma Drug-Marketing Platform: Study by COI "Enabler" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The value of medical journals in providing physicians, researchers and other medical professionals an honest glimpse of the latest relevant, peer-reviewed medical science has greatly diminished in recent years. An extensive review published in the journal PLOS Medicine shows that medical journals today serve as little more than marketing platforms for pharmaceutical companies to push their drugs with little in the way of unbiased science.


Richard Smith, who served as an editor of the prestigious British Medical Journal (BMJ) for 25 years before resigning in 2004, warns that a bulk of the studies published in medical journals are pioneered by drug companies. More often than not, these studies push the agenda of the companies that launched them, procuring positive results that were cunningly derived through industry sleight of hand.


We’re not talking about pharmaceutical advertising here, which is also highly endemic in terms of conflicts of interest. We’re talking about studies — mainly randomized clinical trials — launched by drug companies that arrive at predetermined outcomes and are widely perpetuated in the medical literature to create the illusion that drugs and vaccines are safe and effective.


“Journals have devolved into information laundering operations for the pharmaceutical industry,” wrote Richard Horton, editor of The Lancet journal, back in March 2004, just one year before Smith published the review in question.


It’s not so much drug advertising as it is sponsored trials that corrupt medical journals


Although pharmaceutical advertising renders the quality of what’s been published in a given medical journal questionable, at least readers of that journal can see these advertisements and determine how seriously to take the contained studies. However, when the studies themselves are industry-sponsored and this is not disclosed, things get messy.

Pharma Guy's insight:


Richard Smith is what Tom Stossel calls a conflict-of-interest "enabler" -- or is it "instigator"? Whatever! You might enjoy reading my review of Stossel's new book, PHARMAPHOBIA. Available here (for a limited time): http://bit.ly/pmn140402pphobia 

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Tom Stossel Attempts to Debunk the Conflict-of-Interest "Myth"

Tom Stossel Attempts to Debunk the Conflict-of-Interest "Myth" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Yesterday, I interviewed Thomas P. Stossel, M.D., visiting scholar at the American Enterprise Institute for Public Policy Research, about his new book, PharmaPhobia, and his call to action against the "Conflict of Interest Movement," which he claims undermines American medical innovation. You can hear some of his main arguments in the 5-minute audio snippet from that interview (here: http://bit.ly/1Fw2o7d). You can listen to the full interview here.


Stossel uses many combative terms to describe the focus of his critique. In his book and in the interview, Stossel repeatedly refers to the "Conflict-of-Interest Movement," "Conflict-of-Interest Narrative," and conflict-of-interest "instigators, enablers and enforcers.” 

Here's a sample of his acerbic style: “The case underlying the conflict-of-interest movement is a mixture of moralistic bullying, opinion unsupported by empiric evidence, speculation, simplistic and distorted interpretations of complicated and nuanced information, superficially and incompletely framed anecdotes, inappropriately extrapolated or irrelevant psychological research results, and emotionally laden human-interest stories.” 

Tell us what you REALLY think Dr. Stossel! To me this sounds like every pharmaceutical marketing campaign, especially the part about "emotionally laden human-interest stories" (read, for example, "Online e-Patient & Celebrity Patient Video Testimonials"). 

But will his book, which ends with a section on "What is to be done," turn the tide as he hopes it will?


More here: http://bit.ly/1Fw2o7d 

Pharma Guy's insight:


Stossel hopes that his book will be read by read by the general public. But he himself admits "it's really complicated and even intelligent, well-educated people -- even doctors -- don't understand innovation and how wrong" are the conflict-of-interest movement is. Also, the book is over 300 pages long, which is beyond modern-day readers' attention spans.


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National Press Foundation's Journalist Training is a Winning Proposition for Pharma

National Press Foundation's Journalist Training is a Winning Proposition for Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Once again the National Press Foundation’s programs are raising conflict of interest questions for journalists. This time the NPF is sponsoring its seventh training session on covering cancer this month in Washington, and in February there will be another training event on obesity held in Phoenix. Both are enticing. The prospect of lots of story ideas, reporting strategies and as the website advertises, “a solid list of sources and resources, including access to audio, slides and some video from speakers” is hard to resist in this age of diminished travel budgets and fast turnarounds for copy. Expense-paid trips, ready-made material, and the ability to get an expert on the phone quickly is a heaven-sent opportunity.


National Press Foundation training programs, however, are hardly pure. These events are often sponsored by corporations that don’t shell out money to fly 15 or 20 journalists to Washington or Phoenix and keep them housed and fed for four or five days for nothing. The funder list, which does include a sprinkling of media organizations and others like AARP, reads mostly like a who’s who of corporate America with Bayer, the Mayo Clinic, and Eli Lilly among the health care companies making the Chairman’s Circle, presumably reserved for large donors. The NPF’s website soliciting new sponsors isn’t shy about what’s in it for them if they cough up the cash.


“Work with us to find the right blend of training and education of journalists to fit your strategy. A literate journalist is a smarter journalist, and that’s a win-win for everyone.”


Educating and training journalists to fit your business strategy? Sounds like a heaven-sent opportunity for sponsors too. Even though the Foundation chooses the speakers, just getting the company name planted favorably in a journalist’s mind is useful. Bayer, the giant drug maker that concentrates on innovative drugs and novel therapies including those for oncology, is sponsoring the cancer sessions. The NPF website advertises that the “latest treatment regimens” will be discussed and presumably that includes the new (and probably expensive, possibly harmful, and maybe ineffective) drugs in the pipeline—some perhaps made by Bayer or will be someday. The Mayo Clinic is the money behind February’s obesity training in Phoenix, where Mayo has a branch operation. It also has expertise in treating obesity like bariatric surgeries and sells related products such as books and DVDs on diabetes diets and weight loss. Perhaps their experts might be quoted someday or a book mentioned in a self-help piece.

Pharma Guy's insight:

Direct-to-Consumer (DTC) and Direct-to-Physician (DTP) marketing have been the two staples of pharmaceutical marketing for many years. Now there is another kind of pharma marketing emerging: Direct to Journalist (DTJ)!

I have written previously about Pfizer's new strategy to "woo" journalists (see "Chantix 'Roundtable' Apparently Not Round and Not a Table" and "Pfizer's PR Chief: 'How in the hell do we have such a bad reputation?'").


From "A New Era of Pharma Marketing: Direct to Journalist (DTJ)": http://bit.ly/w7xEm 

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Meta Pharma Influence: 1/3 of Meta-Analyses Written by Industry Employees

Meta Pharma Influence: 1/3 of Meta-Analyses Written by Industry Employees | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmaceutical industry influence is known to pervade scientific research, including clinical trials the U.S. Food and Drug Administration requires pharma companies to fund in order to assess their products. For that reason, people who read scientific papers as part of their jobs have come to rely on meta-analyses, supposedly thorough reviews summarizing the evidence from multiple trials, rather than trust individual studies. But a new analysis casts doubt on that practice as well, finding that the vast majority of meta-analyses of antidepressants have some industry link, with a corresponding suppression of negative results.


The latest study, published in the Journal of Clinical Epidemiology, which evaluated 185 meta-analyses, found that one third of them were written by pharma industry employees. “We knew that the industry would fund studies to promote its products, but it’s very different to fund meta-analyses,” which “have traditionally been a bulwark of evidence-based medicine,” says John Ioannidis, an epidemiologist at Stanford University School of Medicine and co-author of the study. “It’s really amazing that there is such a massive influx of influence in this field.”


Almost 80 percent of meta-analyses in the review had some sort of industry tie, either through sponsorship, which the authors defined as direct industry funding of the study, or conflicts of interest, defined as any situation in which one or more authors were either industry employees or independent researchers receiving any type of industry support (including speaking fees and research grants). Especially troubling, the study showed about 7 percent of researchers had undisclosed conflicts of interest. “There’s a certain pecking order of papers,” says Erick Turner, a professor of psychiatry at Oregon Health & Science University who was not associated with the research. “Meta-analyses are at the top of the evidence pyramid.” Turner was “very concerned” by the results but did not find them surprising. “Industry influence is just massive. What’s really new is the level of attention people are now paying to it.”

Pharma Guy's insight:


You might also be interested in reading this Pharma Marketing Blog post: "Basic Science Plagued by Financial Conflicts of Interest"; http://bit.ly/1aEFsC5

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More Docs Debunk COI Myth in NEJM/BMJ & Laud Financial Ties to #BigPharma

More Docs Debunk COI Myth in NEJM/BMJ & Laud Financial Ties to #BigPharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For years, critics have complained that doctors and the pharmaceutical industry have become too cozy, creating all sorts of unseemly conflicts of interest. That's led to a push for new rules to police these relationships and enforce greater transparency.


Now experts are debating whether these measures have gone too far. There's an interesting back-and-forth between doctors in the New England Journal of Medicineand the British Medical Journal on whether conflicts of interest are actually a huge problem in medicine — and whether efforts to regulate them do more harm than good.


Rosenbaum argues that the stigma against doctor-industry collaboration could have all sorts of negative effects. It might mean that effective drugs get to market more slowly. It might mean that experts with important views get ignored or silenced because they happen to work with drug companies. It might mean that "life-saving therapies whose development requires the combined talents of clinicians and industry scientists don’t materialize."


"I’m not suggesting abandoning regulation," Rosenbaum writes. "When the rules work, they protect us and our patients from fraudulent marketing and twisting of facts. But when rules merely cloak an anti-industry bias in the false promise of scientific virtue, we undermine potentially productive research collaborations, dissemination of expertise, and public trust."

Pharma Guy's insight:


You might be interested in reading this Pharma marketing News article: PharmaPhobia & What to Do About It - http://bit.ly/pmn140202pphobia 

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Notes from a Conflict-of-Interest "Myth" Instigator: Big Pharma Has Cures What Don't Ail Ya!

Notes from a Conflict-of-Interest "Myth" Instigator: Big Pharma Has Cures What Don't Ail Ya! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A study published in 2010 found significant financial gifts (up to 69 percent of overall funding) in the state of Vermont between pharmaceutical companies and specialists in psychiatry (Chimonas, et al. 2010). Although all these are covered by “disclosure laws,” which maintain that it is acceptable to have a conflict of interest in this scenario as long as it’s openly stated, it can and should make the average citizen question the validity of research being done in the field of psychiatry.


Furthermore, while it’s no secret that document review procedures are often inefficient within drug companies (Bernhardt, 2003), the public has it all wrong if they suppose that the studies done on their antidepressants are strictly scientific. When JAMA (Journal of the American Medical Association) evaluated the research quality, they found an overwhelming bulk of medical studies “[contained] false or misleading statistics” (Murray, 2009, p.17).


It has been argued that the prevalence of psychiatric drugs in particular arose out of the increasing pressure on psychiatrists to produce evidence-based practices for actual diagnosis, in order to be seen as providing “cures” in the same way as most medical practitioners (Burwell & Stith, 2008, documentary). They needed official guidelines for mental illnesses, and they needed viable treatments. Enter the DSM (Diagnostic Statistical Manual). The first edition consisted of just over 100 mental disorders, quite a step up from the vague general label of lunatic. Now, with the release of the DSM-V, we currently have about 300 mental illnesses. With such numerous options for mental maladies, who couldn’t find a disorder for which they might need a pill? - See more at:


Recently, the media has come out with multiple reports about the changes in the fifth and newest edition of the DSM. Some of these changes include: Disruptive Mood Dysregulation Disorder (temper tantrums), Major Depressive Disorder (bereavement following the loss of a loved one), Binge Eating Disorder (eating too much twelve times in three months), and Adult Attention Deficit Disorder, just to name a few. (Frances, 2012). Of course, the implications of the changes are that you may be slapped with a label and medicated with greater ease.


- See more at: http://baltimorepostexaminer.com/big-pharma-the-business-of-curing-what-ails-you/2015/05/21#sthash.5jD7MOVG.dpuf

Pharma Guy's insight:


The person who wrote this obviously qualifies as a conflict-of-interest myth "instigator' as defined by Tom Stossel in his new book, PharmaPhobia, Read more about Dr. Stossel's attempt to bust the COI "myth" here: http://bit.ly/1Fw2o7d 

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