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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Surprise! #Pharma $ to Docs Continue Virtually Unabated Despite Sunshine Law

Surprise! #Pharma $ to Docs Continue Virtually Unabated Despite Sunshine Law | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The financial relationships between nearly 1,500 drug and device companies and 619,000 doctors, as well as teaching hospitals, are now disclosed publicly under a provision in the Affordable Care Act. Drug companies have long maintained that the relationships assist in drug development and education, while critics argue the payments skew physicians’ prescribing and research decisions.

 

Despite the increased scrutiny, payments to Connecticut doctors [as an example] declined only slightly in the last two years — from $28.3 million in 2014 to $24.9 million in 2015. Nationally, the total paid to physicians also remained relatively steady: $3.7 billion in non-research payments in 2014 and $3.63 billion in 2015.

 

In Connecticut, more than half of all payments went to physicians in two specialties: internal medicine ($10.9 million) and orthopedic surgery ($3 million). Psychiatrists and neurologists followed, with $2.5 million in payments.

 

Companies that paid the most to Connecticut doctors were AbbVie, Arthrex, AstraZeneca and Pfizer, each of which spent more than $850,000 in Connecticut. Nationally, two of those drug makers — Pfizer and AstraZeneca — were among the top 10 highest-paying companies. Novartis Pharmaceuticals topped the national list, with $539 million in payments, followed by Genentech at $470 million and Pfizer at $436 million.

 

Dr. Joseph Ross, an assistant professor of medicine at the Yale School of Medicine who has written about the industry’s influence on physicians, said he was surprised that the 2015 payments, nationally and in Connecticut, had not declined.

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AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine

AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly 100 national and state medical societies from around the United States are backing a Senate bill (see “21st Century Cures: Hide CME Payments & Allow Off-Label Promotion”; http://sco.lt/62vgQr) that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education, or CME, sessions, medical journals, or textbooks. Among them are the American Medical Association and the American College of Cardiology.

 

The move is the latest push in a long-running effort to roll back requirements for reporting such payments to a federal database, which tracks financial relationships between companies and physicians. Known as OpenPayments, the database was launched in 2014 in response to concerns that financial ties between drug firms and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. A recent analysis found that payments can affect prescription rates.

 

But more than once over the past few years, the Centers for Medicare and Medicaid Services, which maintains the database, appeared to change its mind on reporting requirements for CME payments, in particular. These payments are made by manufacturers or group purchasing organizations to CME providers, which are either commercial firms or nonprofits that organize courses for physicians.

 

CME has been a particularly controversial issue, with accusations that drug and device companies not only fund the courses but they also tightly control the educational curriculum. Last year, industry support for CME totaled $693 million, a 2 percent rise, from the previous year, according to the latest report from the Accreditation Council for Continuing Medical Education, which regulates CME activities.

 

In late 2014, CMS ultimately decided that reporting CME payments would be required. As far as the agency is concerned, medical information — whether in the form of courses, journals, or textbooks — has value that physicians would otherwise have to pay for themselves. However, the CMS decision prompted a lobbying push by industry and medical societies to eliminate the reporting requirement.

 

The support from the medical societies for the bill, which is called the Protect Continuing Physician Education and Patient Care Act, is hardly surprising. In a letter to US Senator John Barrasso, a Wyoming Republican and a physician who introduced the bill, the medical groups argue, however, that Congress initially intended to create such exemptions and CMS may hurt medical practice.

 

“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by CMS that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent” CME, they wrote to Barrasso in a June 30 letter.

 

“When a company gives a grant to an accredited CME provider, it’s pretty hands off. They’re not supposed to suggest speakers or influence the curriculum, for instance,” said Thomas Sullivan, president of Rockpointe. “So if a company that supports commercial CE has no control (over the use of its grant dollars), I don’t see why that should be reported. Doctors don’t have the direct relationship with the company.”

 

“It’s a stretch to view free textbook and free medical education as being anything other than a benefit to physicians,” said Daniel Carlat, who runs a company that publishes CME newsletters for mental health practitioners. “These are not direct benefits to patients. The only way these would benefit patients is if a drug company gave free books or courses to patients themselves.”

Pharma Guy's insight:

For a closer look at CME funding data, read "For First Time in Seven Years, Pharma Support of CME Increases"; http://bit.ly/1Ctqf8D 

 

As you can see from the charts, most of the increase in CME funding comes from for-profit CME providers - those so-called "hands-off" 3rd parties. With regards to pharma grants to such groups, it's widely understood that pharma's hands remain "off" perhaps the first time, but if the pharma sponsor is not satisfied with the MECC's CME program, then there may not be a second round of funding via that "independent" CME provider.

 

A Pharma Marketing News survey asked respondents if CME activities that accept commercial support from pharmaceutical companies have more bias that activities that don't and what should be done to limit any potential bias. About one third of respondents said that pharma/device companies should cease funding CME courses provided directly by for-profit, third-party companies (eg, medical education and communication companies), but continue paying for courses offered by medical schools, teaching hospitals and medical societies. Another third disagreed and the rest weren't sure. For more, see http://www.surveys.pharma-mkting.com/PharmaCME.htm

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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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College of Family Physicians' "Do Nothing" Physician Payment Recommendation

College of Family Physicians' "Do Nothing" Physician Payment Recommendation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A report written by the College of Family Physicians in Canada about how to prevent conflicts of interest between doctors and the pharmaceutical is being criticized for weak recommendations, with none of them explicitly banning the accepting of money from the drug industry.


The report makes 20 recommendations dealing with issues such as conflict of interest, financial relationships, marketing and other relationships with the pharmaceutical and health care industries.

But they don't prevent a doctor with ties to the pharmaceutical industry from serving in leadership positions, sponsoring certain events, or even from contributing to an "unrestricted" education fund.


Alan Cassels, a drug policy researcher at the University of Victoria, is critical of the college for sitting on the report as long as it did.


University of Victoria drug policy researcher Alan Cassels says he beleives the report was held back because it is "basically recommending the status quo between physician education and the pharmaceutical industry.”

He suspects the college held it back because it's "pretty embarrassing."

"They're basically recommending the status quo between physician education and the pharmaceutical industry,"

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Most UK HCPs Back ABPI's Plan to Publish Pharma Industry Payments to Doctors, Nurses, and Pharmacists

Most UK HCPs Back ABPI's Plan to Publish Pharma Industry Payments to Doctors, Nurses, and Pharmacists | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most clinicians back moves to make payments received from pharma companies more transparent, finds a survey commissioned by the industry body, the Association of the British Pharmaceutical Industry (ABPI).


But a significant minority of GP respondents said they would be less likely to work with pharma companies as a result, finds the poll, carried out by the ComRes consultancy.


Among 500 healthcare professionals questioned, including 127 GPs and similar numbers of hospital pharmacists, nurses, and specialists, 87% agreed that payments from pharmaceutical companies to individually named healthcare professionals should be transparent. 


Seven out of ten (69%) with a current relationship with one or more pharma companies said that they have already given or are likely to give permission for the companies they work with to disclose their payment information.


The survey results come amid preparations to disclose details of payments and other transfers of value pharmaceutical companies have made to individual healthcare professionals and healthcare organisations this year on a publicly accessible, searchable database that will be hosted on the ABPI's website from June 2016.

 

The initiative is part of a Europe-wide programme to boost transparency in respect of the relationships between the industry and the healthcare sector.


Dr Virginia Acha, the ABPI’s Executive Director Research, Medical and Innovation, said that these relationships were important for the development of new treatments and patient care.


Nevertheless, one in three (32%) of those questioned felt it unnecessary to declare payments from pharmaceutical companies to individually named healthcare professionals, while one in four (26%) believe that declaring these payments will adversely affect medical innovation. 


Three out of four said that the disclosure of payments from pharmaceutical companies will have no effect on their relationship with these companies, but views differed according to professional group, the survey found.


Around a quarter (23%) of the GPs said they would be less likely to work with the industry in the future as a result of the publication of these data, which is considerably higher than hospital specialists (17%), pharmacists (10%) or nurses (6%).

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Should Doctors Wear Sponsor Uniforms? Big Pharma Courtship Goes Public

Should Doctors Wear Sponsor Uniforms? Big Pharma Courtship Goes Public | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Big Pharma is notorious for seducing doctors and medical institutions. The facts are finally out, and the amount spent marketing drugs to doctors is overwhelming. David Michaelis commentary.


I want to know — and I’m sure you do, too — what conflicts of interest my general practitioner has. Are they prescribing me the best medicine, or the one that sponsors them? Maybe you should ask your doctor if they will wear this uniform, just so we’re all clear on where they are coming from.

Pharma Guy's insight:

I suggested this in 2008 BEFORE the sunshine law was a glimmer in lawmakers' eyes: "Come to think of it, this might be a good way for doctors to supplement their incomes AND it would be transparent to patients from which companies their doctors received gifts." Inspired by a New Yorker cartoon: http://bit.ly/1TQcbsc 

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Pharma's Hidden CME Payments

Pharma's Hidden CME Payments | Pharmaguy's Insights Into Drug Industry News | Scoop.it
New rules will require manufacturers to report some indirect payments made to physicians for CME activities.


But...


The Centers for Medicare and Medicaid Services updated reporting requirements for continuing medical education, pushing back the deadline for manufacturers to start reporting indirect payments to the Open Payments database by one year.


Drug and medical device manufacturers that pay third-party CME providers to hire physicians for education events are required to report those payments to the CMS if they find out the identify of the doctors who spoke or attended the event within one year.


CME advocates believe that this will mean the majority of CME payments will still remain unreported. Others have said they expect more reporting because manufacturers tend to find out the identify of the speakers.


The indirect payments that meet the new reporting threshold now have to be reported to the CMS starting in 2017 and will eventually be published in the Open Payments database, according to guidance issued by the CMS on Friday. The CMS defines direct payments as transfers of value made directly by the manufacturer to the physician or teaching hospital.


In 2014 the CMS revised reporting requirements for CME payments, removing a carve-out that it had created in the rulemaking process that exempted reporting of CME activities that fit certain categories, such as activities conducted by companies that are accredited by the ACCME, one of the nation's largest accrediting bodies. The revision was criticized by organizations that represent CME providers and drugmakers.


Those groups have advocated in Washington for legislation that would again provide an exemption. The sweeping 21st Century Cures Act that passed 344-77 in the House of Representatives in mid-July would exempt CME payments from reporting.

Pharma Guy's insight:

Also, ACCME's annual report does not break down income from "other" sources, but I suspect that at least some of that income originates from the drug industry through grants made to medical societies and private medical education communication companies (MECCs). These grants may not be included in the  "commercial" support category. For more on that, go here: http://bit.ly/1Ctqf8D 

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Pharma Pays Male Docs More Than Female Docs for Same Services (& Lunch!)

Pharma Pays Male Docs More Than Female Docs for Same Services (& Lunch!) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background


Academic literature extensively documents gender disparities in the medical profession with regard to salary, promotion, and government funded research. However, gender differences in the value of financial ties to industry have not been adequately studied despite industry’s increasing contribution to income and research funding to physicians in the U.S.


Methods & Findings


We analyzed publicly reported financial relationships among 747,603 physicians and 432 pharmaceutical, device and biomaterials companies. Demographic and payment information were analyzed using hierarchical regression models to determine if statistically significant gender differences exist in physician-industry interactions regarding financial ties, controlling for key covariates. In 2011, 432 biomedical companies made an excess of $17,991,000 in payments to 220,908 physicians. Of these physicians, 75.1% were male. Female physicians, on average, received fewer total dollars (-$3,598.63, p<0.001) per person than men. Additionally, female physicians received significantly lower amounts for meals (-$41.80, p<0.001), education (-$1,893.14, p<0.001), speaker fees (-$2,898.44, p<0.001), and sponsored research (-$15,049.62, p=0.05). For total dollars, an interaction between gender and institutional reputation was statistically significant, implying that the differences between women and men differed based on industry’s preference for an institution, with larger differences at higher reputation institutions.


Conclusions

Female physicians receive significantly lower compensation for similarly described activities than their male counterparts after controlling for key covariates. As regulations lead to increased transparency regarding these relationships, efforts to standardize compensation should be considered to promote equitable opportunities for all physicians.


Pharma Guy's insight:

The sunshine act shines light on "glass ceiling" of physician payments!

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"Free Lunch Flaw" Loophole in Aussie Pharma-Doc Code of Conduct

"Free Lunch Flaw" Loophole in Aussie Pharma-Doc Code of Conduct | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Patients will find out what payments and "educational" trips their doctors have received from drug companies, after the Australian Competition and Consumer Commission approved a new code of conduct for the pharmaceutical industry.

But in a change criticised by health consumer groups, companies will no longer be required to report how much they spend wining and dining doctors.

The new Medicines Australia code of conduct, which is expected to come into force next month, says companies must not spend more than $120 per person per meal on food and drinks, but does not require the disclosure of this spending, and drops the current requirement for companies to publicly report the total amounts they spend on such hospitality.

The Consumers Health Forum said the more detailed reporting of "transfers of value", which will enable patients to see what individual doctors have received from drug companies in speaking and consulting fees, and flights and accommodation, was an "important step forward." The new code closes a loophole in an earlier draft which would have allowed doctors to opt out of the system.


But chief executive Leanne Wells said by agreeing not to require companies to disclose spending on meals, it had opened a $120 "free lunch flaw".


"That would seem to make it possible for companies to entertain doctors to a decent meal frequently, without the matter coming to the notice of patients or the public," Ms Wells said.

Pharma Guy's insight:


Pharma payments for meals for docs are under the table down under! :-) I wonder if pharma companies in Australia will follow Novartis and entertain physicians at Hooters? (Is there Hooters in Australia?). Read Novartis Wines -- er, Beers -- and Dines Docs at Hooters! http://bit.ly/PMBalbum042713  (very funny!)

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The Slippery Slope of Pharma Physician Phreebies

The Slippery Slope of Pharma Physician Phreebies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most physicians do not seem to know that "there is no such thing as a free lunch." Medscape's 2012 Ethics Report survey, for example, revealed that 72% of 23,710 physician respondents answered "Yes" to the question "Do you feel that you could be unbiased with prescribing habits if you accept lunches from pharmaceutical representatives?" (see here).

But, according to other researchers, such thinking is a "slippery slope" on which "Physicians fail to recognize their vulnerability to commercial influences due to self-serving bias, rationalization, and cognitive dissonance" (see "Physicians Under Pharma's Influence: Are Physicians Powerless Pawns of Pharma Psychology?").


While the general public is concerned about the cost of insurance under the Affordable Care Act, physicians are concerned about the Physician Payment Sunshine provision of the law, which requires pharma companies to report many kinds of payments to physicians, including the value of "free lunches." That information will be made public in 2014.

Leana Wen, M.D., author of "Who's My Doctor? The Total Transparency Manifesto," summed up physicians' attitude regarding the sunshine provision this way: 


"Doctors need drug companies. We’re not influenced by them. They just pay for lunches, and I need to eat. Bedsides, it’s not my patients’ business what I do."

 Dr. Wen, however, believes that patients should know where their doctors get their money, especially if they are getting paid by drug companies and medical device companies.

Pharma Guy's insight:


"Dozens of studies have shown that even small gifts affect physicians’ prescribing habits," says Dr. Wen, "and that doctors suffer from the 'you but not me' phenomenon -- where we believe our own prescription habits aren’t affected (which implies that pharma is somehow wasting their marketing efforts, a contention we know is not true)" (see "To the Doctors: Why We Need to Be Transparent With Patients").

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Your Doctor Should Reveal Their Biases and Pharma Ties

Your Doctor Should Reveal Their Biases and Pharma Ties | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Should your doctor reveal their positions on contraception and whether they accept money from drug companies?


Studies have reported that around 94% of doctors have some sort of relationship with pharmaceutical companies. One study published in the New England Journal of Medicine found that more than one third of physician respondents received reimbursement from drug companies for costs associated with meetings or continuing education, and over a quarter received payments for enrolling patients in trials, or for consultations and lectures. Patients can already see if their doctor has received compensation from drug companies on ProPublica’s database, Dollars for Docs—but one physician wants to take that a step further.


Dr. Leana Wen, director of patient-centered care research at George Washington University recently launched “Who’s My Doctor,” a platform where doctors can sign a Total Transparency Manifesto and disclose what outside funding they receive, what proportion of their pay comes from where and, if they’re willing, details about their family, political affiliation and philosophy of practice. For instance, a woman may want to know how her doctor feels about contraception, or abortion, or early breast cancer screenings. Parents might want to know how a doctor feels about routine vaccination. They can also, of course, see which drug companies, if any, the doctor has ties to.

“Dozens of studies have shown that when docs receive money from drug companies—even a free lunch—it does affect prescription behavior,” she says. Indeed, despite doctors’ assurances that pharmaceutical relationships don’t interfere with patient care, other research and investigations has showed it does.

Pharma Guy's insight:


Doctors in the US who are paid and entertained by drug companies are more than twice as likely to prescribe their products, according to a "groundbreaking new study on the influence of industry marketing on medical practices" (find the study attached to this post). The findings are based on "recently released data that 12 companies have been forced to make public as a result of US regulatory settlements," reports the Financial Times.

"Among a sample of 334,000 physicians, researchers found a typical doctor had a 13 per cent chance of prescribing the drugs of a dozen leading pharmaceutical companies. Among the 193,000 who received meals or speaking, consulting or other fees from the companies, the probability jumped to nearly 30 per cent."


More here, including chart: 

Paid Docs Twice as Likely to Prescribe Sponsors' Drugs - But They Must Be Paid Well! Is the ROI Worth the Bad Press?
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Art Jones's curator insight, October 7, 2014 10:55 AM

Kudos to Dr. Leana Wen for launching the website "Who's  My Doctor" which provides patients visibility into facets of a participating  physicians funding sources as well as their philosophy on everything from contraception to how they feel about routine vaccinations.


 

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Docs Complain to CMS About ‘Sunshine’ Data Disclosures

Docs Complain to CMS About ‘Sunshine’ Data Disclosures | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A group of medical societies and pharmaceutical industry trade groups is pushing the government to flesh out data that will be published next month showing how much drug makers pay doctors.


They sent a letter today to the Centers for Medicare and Medicaid Services to ask the agency to explain what context will be provided to help the public understand the justification for payments, such as speaking fees and grants used to bankroll clinical research.


The letter is signed by more than 20 medical societies and organizations including the American Urological Association, as well as heavyweight industry trade groups Biotechnology Industry Organization and the Pharmaceutical Research & Manufacturers of America.


The missive was sent as CMS plans to post the payment data in an online, searchable database as required in the Sunshine Act provision of the Affordable Care Act. The provision was passed in response to concerns that medical practice may be unduly influenced by industry.


The law requires most drug and device makers to report to CMS detailed information about payments and gifts provided to U.S. doctors and teaching hospitals. The disclosures are being made in stages, but September marks the debut when payments will appear publicly.

Supporters of the Sunshine Act say the transparency will provide useful information to patients about the relationships their doctors may have with drug or device makers, and serve as a deterrent to the more extreme examples of industry money unduly influencing medical care.


But some doctors and companies fear payment data will be misinterpreted by the public, or painted with a broad brush. They say there are legitimate interactions that serve to advance medicine, and that doctors should be compensated for services such as consulting for a company about the development of a new product.


Some medical societies teamed up with industry groups to form Partners for Healthy Dialogues, to defend such interactions between industry and doctors, and some of its members signed the letter sent to CMS.


The medical societies and industry trade group lament what they write in the letter is a dearth of context that accompanied CMS’s milestone release of Medicare Part B payments to physicians earlier this year.


Some medical groups say the data did not include context to show which doctors may be abusing the system and which were receiving big payments because of high overhead costs.

Pharma Guy's insight:


A survey revealed that of the more than 1,000 physicians questioned, over half admitted they didn't know that the law requires pharmaceutical and medical device companies to report on expenditures annually, without physician review of the data to correct any inconsistencies or errors, prior to submission to the government. 63% were deeply concerned that a record of these payments will be available in a publicly searchable database.


Listen to this podcast: Physicians Unprepared for Sunshine Law


Questions/Topics Discussed


  • Background regarding the sunshine law, including important dates for implementation.
  • Survey methodology
  • A summary of survey results and what they tell us -- pharma companies might be surprised!
  • How can physicians review the data before it goes public to correct inaccuracies.
  • What is at stake for pharma companies if they do not work more closely with physicians regarding access to the data?
  • What the industry must do to educate their physician clients about the Sunshine Law
  • Will this new form of "Big Data" eventually lead to a significant decrease in payments of all kinds to physicians by the drug industry?


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Don’t Keep Pharma Payments in Support of CME Behind a Curtain, Says @Pharmalot

Don’t Keep Pharma Payments in Support of CME Behind a Curtain, Says @Pharmalot | Pharmaguy's Insights Into Drug Industry News | Scoop.it

To keep doctors current on medical issues, drug makers help pay for continuing education. Until now, though, industry has not had to report the value of these sessions to a federal database created in response to mounting concerns that such payments may unduly influence medical research or practice.

 

That is expected to change next year, however, when a new reporting requirement kicks in. And many physicians are pushing back.

 

Already sensitive about financial disclosures about meals and research grants, many doctors are backing a Senate bill to exempt drug and device makers from reporting the value of continuing education, journal reprints, and textbooks provided to physicians. They argue that patients will lose out if companies choose to curtail their financial support when the reporting requirement goes into effect next year. [Fore more on that, read “AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine”; http://sco.lt/9KptUv]

 

“This bill will move us backwards, not forwards in seeking greater transparency in science,” said Paul Thacker, a former US Senate Finance Committee investigator who probed financial ties between industry and physicians and helped craft the law that created the database. “This initiative smells of money coming from industry to prop up biased continuing medical education and industry-supported studies that serve to market drugs to doctors.”

 

As it so happens, health professionals were the largest financial contributors to Barrasso over the last five years, while the pharmaceutical industry was his third-largest financial supporter, according to the Center for Responsive Politics.

 

Will companies cut back on such support because of another reporting requirement? It’s true drug makers and continuing education providers will have more paperwork, because industry support for continuing education is not paid directly to doctors. Instead, values will have to be assigned.

 

The purpose of the database is to provide transparency. Carving out exceptions only keeps information behind a curtain.

Pharma Guy's insight:

Recent data from ACCME (see chart in this post) shows that pharma is increasing it support of CME, which may indicate that the industry believes CME payments will be carved out of the sunshine law.

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How Big Pharma Courts Physicians & Makes Them Look Like They Have a Lot of Money!

How Big Pharma Courts Physicians & Makes Them Look Like They Have a Lot of Money! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Truth In Media Project has released Part 3 of its latest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 3, titled How Big Pharma Manipulates Physicians and Corrupts “Best Practices,” discusses how companies in the pharmaceutical industry influence doctors’ “best practices” as well as offer funding for research and court physicians and their staff in hopes of gaining loyalty.

 

Devon Beasley, a registered nurse, has spent years in her field and told Truth In Media that she has seen representatives for pharmaceutical companies “wine and dine” an entire medical office in the midst of promoting various products. “Some of the offices that I would apply for would actually tell me ‘hey, we have catered lunches three times a week.’ That’s directly from pharmaceuticals. You also get materials for your office that make your office look really great,” said Beasley. “They will bring in supplies that make your office look like you have a lot of money.”

 

Beasley went on to say that medication samples, which are common in the doctors’ office and part of the pharmaceutical companies’ strategy to promote certain products, are highly sought after by patients and can conflict with the pursuit of proper medical care. “No one is asking which is the safest medication, which is the best for me, which is best for the patient. It’s all about ‘do you have samples, do you have coupons? Can you prescribe me something that does have a coupon? Can you prescribe me something that does have a sample?’ And it has nothing to do with which one is best, most effective or safest,” said Beasley.

 

Truth In Media’s Ben Swann also discussed the pharmaceutical industry’s impact on the medical community’s procedures known as “best practice,” which is the name for a system of policies that have been agreed upon by doctors and regulatory agencies such as the FDA. Swann explained that “the problem with best practices is how it is manipulated by big pharma. Research that best practice is based on is heavily funded by big pharma.”

Pharma Guy's insight:

“They will bring in supplies that make your office look like you have a lot of money.” LOL!

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GSK "Sunshine Blocks" Outside Docs: No More $ For You!

GSK "Sunshine Blocks" Outside Docs: No More $ For You! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest.

The announcement appears to be a first for a major drug company — although others may be considering similar moves — and it comes at a particularly sensitive time for Glaxo. It is the subject of a bribery investigation in China, where authorities contend the company funneled illegal payments to doctors and government officials in an effort to lift drug sales.

Andrew Witty, Glaxo’s chief executive, said in a telephone interview Monday that its proposed changes were unrelated to the investigation in China, and were part of a yearslong effort “to try and make sure we stay in step with how the world is changing,” he said. “We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

Pharma Guy's insight:

Re: GSK in China, read "GSK, GSK, GSK: TSK, TSK, TSK!"; http://bit.ly/GSKTSKTSK 


Meanwhile, you can find some numbers regarding GSK's payments to physicians here: "Pharma Begins to Reveal Payments to Physicians"; http://bit.ly/pmn9103p 

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EU and UK Physician Payment Sunshine Coming - May Eclipse US Version

EU and UK Physician Payment Sunshine Coming - May Eclipse US Version | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In June 2012, the “code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations” was announced by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Starting 1 July 2016, the Association of the British Pharmaceutical Industry (ABPI) will publish details of British pharmaceutical company payments made to healthcare professionals, including nurses and pharmacists.

This goes beyond the US Physician Payment Sunshine Act, which doesn’t require companies to publicly report payments to nurse practitioners or physician assistants, even though they are allowed to write prescriptions in most states (see here). This, however, may change if legislation proposed by Sen. Charles Grassley, R-Iowa, and Sen. Richard Blumenthal, D-Conn., becomes law. The legislation would expand the disclosure requirement beginning in 2017 to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives (read more about that here).

What do UK health professionals think of ABPI's plans to publish these data?


Click here to find out.

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Senate Bill Would Bring Sunshine to #Pharma Payments to Nurses & Physician Assistants

Senate Bill Would Bring Sunshine to #Pharma Payments to Nurses & Physician Assistants | Pharmaguy's Insights Into Drug Industry News | Scoop.it

bill proposed Wednesday by two U.S. senators would require drugmakers and medical device manufacturers to publicly disclose their payments to nurse practitioners and physician assistants for promotional talks, consulting, meals and other interactions.


The legislation would close a loophole in the Physician Payment Sunshine Act, which requires companies to report such payments to doctors, dentists, chiropractors, optometrists and podiatrists. Companies have so far released more than 15 million payment records, covering August 2013 to December 2014.


As ProPublica and NPR reported in July, the 2010 law doesn't include nurses with advanced degrees or physician assistants, even though they, too, can prescribe medications. Some have gotten in trouble for accepting kickbacks.


The bill, introduced by Sen. Charles Grassley, R-Iowa, and Sen. Richard Blumenthal, D-Conn., would expand the disclosure requirement beginning in 2017 to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives.


"We think that the void should be filled in order to have a complete record," Grassley said in an interview. "Transparency isn't an end to itself. Transparency is meant to bring accountability."


Because the data aren't publicly reported, it's unknown how much money these professionals receive from makers of drugs and medical devices, or whether that figure has increased since disclosure of payments to doctors was required. But in recent years, a few nondoctors have been criminally charged with taking kickbacks from industry.


A nurse practitioner in Connecticut pleaded guilty in June to taking $83,000 from Insys Therapeutics in exchange for prescribing its high-priced medication Subsys to treat cancer pain. In some cases, she delivered promotional talks attended only by herself and a company sales representative.


And in 2012, a physician assistant in Rhode Island was sentenced to six months in prison and six months of home confinement after pleading guilty to taking kickbacks from a medical device company. The company paid him $50 to $300 for each bone growth stimulator ordered by the surgeon he worked for — all told, some $120,000 between 2004 and 2011. The company, Orthofix, and several of its officials also pleaded guilty to charges including fraud, obstruction, kickbacks or perjury.


Blumenthal, the new bill's co-sponsor, said the Connecticut case was "a clear, loud alarm bell."


"Doctors need to be held accountable, but so do all the other providers," he said. "Requiring these companies to disclose gifts and payments made to other health care providers, not just doctors, is absolutely necessary in today's world."

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Sunshine in the UK? Not an Oxymoron as Doctors May Have to Declare Links to Drug Companies

Sunshine in the UK? Not an Oxymoron as Doctors May Have to Declare Links to Drug Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Medical professionals could be ordered to declare any financial ties to pharmaceutical companies under plans being considered by ministers


Doctors and health officials could be ordered to declare any financial ties to pharmaceutical companies under plans being considered by ministers.

NHS England said an investigation by The Telegraph into senior staff receiving money from drugs firms raised the question of whether the Government should legislate for full disclosure of payments made to health professionals. Jeremy Hunt, the Health Secretary, is understood to be considering a new law.


Multiple inquiries were launched by the NHS yesterday into revelations by The Telegraph that health service staff are being paid thousands of pounds by drug companies lobbying them to use their products.


The undercover investigation disclosed how senior health officials who help decide which drugs are used by GPs and hospitals are being paid to work as consultants for pharmaceutical companies who want the National Health Service to “switch” to medicines they produce.

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Pharma Payments to Nurses & Physician Assistants Go Unreported

Pharma Payments to Nurses & Physician Assistants Go Unreported | Pharmaguy's Insights Into Drug Industry News | Scoop.it
New data on drug and device company payments to doctors largely excludes nurse practitioners and physician assistants, though they play an ever-larger role in health care. One advanced-practice nurse pleaded guilty last month to taking drug company kickbacks.


the federal Physician Payment Sunshine Act doesn’t require companies to publicly report payments to nurse practitioners or physician assistants, even though they are allowed to write prescriptions in most states.


Nurse practitioners and physician assistants are playing an ever-larger role in the health care system. While registered and licensed practice nurses are not authorized to write prescriptions, those with additional training and advanced degrees often can.


A ProPublica analysis of prescribing patterns in Medicare’s prescription drug program, known as Part D, shows that these two groups of providers wrote about 10 percent of the nearly 1.4 billion prescriptions in the program in 2013. They wrote 15 percent of all prescriptions nationwide (not only Medicare) in the first five months of the year, according to IMS Health, a health information company.


For some drugs, including narcotic controlled substances, nurse practitioners and physician assistants are among the top prescribers.


“Nurse practitioners see patients, order tests, recommend procedures and prescribe medications,” Dr. Walid Gellad, an associate professor of medicine at the University of Pittsburgh and co-director of its Center for Pharmaceutical Policy and Prescribing, wrote in an email. “It seems straightforward to think that their relationships with the pharmaceutical and device industries are of as much relevance as physicians, dentists, chiropractors, etc.”


He added, “If the purpose of the act is to shine a light on the relationship between industry and the health care sector, then you’ve left out an important component of that sector.”


Elissa Ladd, an associate professor of nursing at the MGH Institute of Health Professions in Boston, surveyed 263 nurse practitioners several years ago about their interactions with the pharmaceutical industry. Her survey, published in 2010 in the American Journal of Managed Care, found that nearly all had regular contact with drug company sales representatives. Nine in 10 believed that it was acceptable to attend lunch and dinner events sponsored by the industry.


Ladd said she supports mandatory disclosure of payments for nurse practitioners and physician assistants.


“Nurse practitioners think that they’re somewhat immune to this but I think that we’re no different than any other provider,” she said. “If nurse practitioners were reported on, I think that would be a huge concern for them. I don’t think they want to be perceived in a negative light.”

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Aussie #Pharma-Doctor Transparency Regime Has Loopholes You Can Drive a "Road Train" (Big Long Truck) Through

Aussie #Pharma-Doctor Transparency Regime Has Loopholes You Can Drive a "Road Train" (Big Long Truck) Through | Pharmaguy's Insights Into Drug Industry News | Scoop.it

By comparison with the US provisions, Australia’s incoming new rules are pusillanimous, with loopholes you could drive a road train through. All payments classified as “research and development” will be excluded, as will all meals under $120. That means your GP could be wined and dined every second week, hearing company-sanctioned spin on the latest drugs and the diseases that go with them, with direct impacts on your care, with no way of you knowing.


Wining and dining is not a thing of the past. In 2014 drug companies provided hospitality for doctors, nurses and pharmacists at more than 30,000 events in Australia: more than 100 events every weekday. While most events took place in hospitals, medical centres and universities, many still happen inside hotels, resorts and desirable restaurants. 

Around this time last year, eight Melbourne GPs settled into a cosy educational session about the dangers of high cholesterol, funded by Pfizer, the manufacturer of one of the world’s most profitable cholesterol-lowering drugs. The classroom was the chic Enoteca restaurant in Church Street, Richmond, where diners can enjoy an entrée of rabbit loin with pancetta and parsnip for $25, and a main of Flinders Island lamb for $42. 


Around the same time, Pfizer treated an even more fortunate group of 12 Sydney GPs to a similar “educational” event about cholesterol, this time at the Banjo Paterson restaurant, which boasts pressed quail and pistachio nut terrine, as well as Dom Perignon at just $270 a bottle. The bill for the night was $1732, or $144 per GP. The speaker was paid $2800 for two hours of content.


We know these events occurred because since 2007 drug companies have been forced by law to disclose them. What we don’t know are the names of the doctors attending. It’s long been anticipated that the new wave of disclosure reforms would force companies to name the doctors receiving free meals – as happens in the US – but following a relentless campaign by both industry and parts of the medical profession in Australia, the guest lists will remain secret. And as part of the recent horse-trading with the ACCC, the 2007 reforms have been dramatically watered down, so drug companies will now no longer even have to reveal the amount they spend on hospitality at these events. 


“Not disclosing meals under $120-a-head is a step in the wrong direction,” says Jureidini. He points out that it’s often not the money that influences doctors’ decision-making about which pill to prescribe you, but the feeling of goodwill that creates the need to reciprocate. “Some of the most dangerous perks are labelled as the most innocuous,” he says.

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Interactive Graphical Look into the Open Payments Database

Interactive Graphical Look into the Open Payments Database | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A look at how medical-device makers, drug manufacturers and distributors paid money to U.S. doctors and teaching hospitals during the last five months of 2013.


Thanks to this new interactive graphic, you can locate some of this hard-to-find data that is stored in the Open Payments database, which was launched last week by the federal government in order to provide insights into the financial relationships between industry and health care providers.


The database was created in response to growing concerns that payments by drug and device makers to physicians and teaching hospitals may unduly influence medical practice and research. But the initiative has been marred by glitches and, in particular, a rather poor design.

Pharma Guy's insight:


Interesting. But I wish you could see percentages by mousing over the chart or something like that.


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When It Comes To Transparency, The Pharma Industry Calls for More "Context"

When It Comes To Transparency, The Pharma Industry Calls for More "Context" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

These industry groups do have a reasonable concern. Just providing these data without context could, in fact, be misleading. In addition, reading between the lines, it appears that BIO, PhRMA and AdvaMed have been trying to work with CMS to make this happen but these efforts have failed. However, issuing this letter makes it seem that the industry is trying to stall another well-intended effort to bring transparency to the complex industry-physician relationship. Industry critics can use this an another example of the industry attempting to hide data.


But here’s the bigger issue. The Sunshine Act really shouldn’t be needed. That’s because some of the biggest companies in the biopharmaceutical industry are ALREADY providing highly detailed data, complete with context, on ALL of their payments to doctors, hospitals, and other healthcare providers.


If Lilly and Pfizer can do this, why can’t all do the same? If two of PhRMA’s biggest players have been doing this for years, why aren’t they all? The Affordable Health Care Act has been in effect for four years. It is not as if the industry didn’t see this coming. Rather than trying to work with CMS, BIO, PhRMA and AdvaMed should have been working with their member companies to mimic the transparency initiatives of Lilly and Pfizer. 

Pharma Guy's insight:


In the interest of increased transparency, I think the author (John LaMattina, a former Pfizer executive) should mention that Lilly & Pfizer didn't do this voluntarily as explained in this comment:


"Great article, but the following is a bit misleading: “The Sunshine Act really shouldn’t be needed. That’s because some of the biggest companies in the biopharmaceutical industry are ALREADY providing highly detailed data, complete with context, on ALL of their payments to doctors, hospitals, and other healthcare providers.” Keep in mind that these companies had to do this to comply with billion dollar fraud settlements entered into with the federal government. If it were not for that, I find it unlikely that these companies would have INITIATED this voluntarily. I applaud that they maintain their programs despite the settlements lapsing, but we should not forget how it started."

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Cloudy Forecast on Sunshine Act Data Release?

Cloudy Forecast on Sunshine Act Data Release? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The past release of Medicare payments to physicians resulted in headlines that focused on money paid to specific physicians as well to specific categories of medical practice with stories taking a national and regional focus.  One could expect much of the same from coverage of the Sunshine Act data, set to be published at the end of September.


However, on August 15 ProPublica reported that the government may actually be withholding one-third of the records from the data base that was to be published, though a press release by CMS on the data base makes no such mention of a delay.  A delay would have many likely side-effects, one of which is to impact the nature of the media coverage of the Sunshine Act data.  That could occur in at least two major ways.


First, it becomes somewhat challenging to report on the data if the data is incomplete – particularly to the tune of one-third of the data being withheld.  What is not known by such a disclosure is just as important as what is known.  The stories that would have been written had there been a complete set of data about which physicians – and which types of physicians – have received the most – and which therapeutic areas have had the greatest investment by companies – and which companies have paid the most – all will have to be qualified if data is withheld.  In other words, every story would include the caveat – “based on what we know now…” Certainly a release of partial data if that happens would have a diluting effect on the nature of the coverage.

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