The last of four Florida insurers blasted by AIDS activists for the high cost of their HIV drugs relented last week, saying it would cap what patients pay every month for four types of medication.
“We will voluntarily agree to set an out-of-pocket limitation of $200 per month on each of the following drugs: Atripla, Complera, Stribild, and Fuzeon,” Preferred Medical Plan CEO Tamara Meyerson wrote to Kevin McCarty, commissioner of the Florida Office of Insurance Regulation, in a Jan. 14 letter.
The other three companies — Coventry Health Care, Humana and Cigna — had earlier reached formal agreements with state regulators to lower their prices and to fill prescriptions without prior authorization for 2015.
Preferred did not violate Florida’s anti-discrimination laws, said Amy Bogner, a spokeswoman for the state’s insurance office.
This copyrighted story comes from the Miami Herald, produced in partnership with KHN. All rights reserved.
An estimated 120,000 Floridians have HIV, and nearly half of them live in South Florida, according to state data.
Source:University of California, Los Angeles (UCLA), Health Sciences
Summary:Researchers have proposed a system for off-label drug prescriptions combining reporting, testing and enforcement regulations, and allowing interim periods of off-label use. This would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.
Medicine drugs (Photo credit: Wikipedia)
Off-label use of drugs and medical devices — using approved remedies in unapproved ways — has long been a part of medicine. The practice provides public health benefits but also presents some risks.
For the most part, the U.S. Food and Drug Administration allows physicians to prescribe drugs and devices off-label in the same way they are prescribed for their approved uses. The FDA couldn’t require approval for each off-label use because the burden for approval would be so high that few off-label uses would be approved, which would deprive patients of effective treatments for which the drugs weren’t originally intended.
As a result, health care providers have had to make their own decisions about using drugs off-label, often in the face of uncertain evidence.
To address that issue, researchers from the David Geffen School of Medicine at UCLA have proposed a system combining reporting, testing and enforcement regulations, and allowing interim periods of off-label drug prescription. Their recommendations, published in the Duke Law Journal, would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.
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The authors’ proposal comprises three elements:
• Improved reporting of off-label use through disclosure of diagnostic codes in reports to the FDA, in detailing data that pharmaceutical companies obtain on physicians’ prescribing habits, and in reports to the FDA and Medicare/Medicaid reimbursement requests. This information, which would omit details that could identify individual patients, could then be shared with academics and pharmaceutical companies for use in research. • Expansion of post-market testing requirements for off-label use of drugs and medical devices. • A tiered labeling system for drugs consisting of “red box” warnings that prohibit certain off-label uses; informed consent from patients receiving prescriptions for off-label use of some drugs that currently carry “black box” warnings, which identify drugs that pose a significant risk of serious or life-threatening adverse effects; and the creation of a new “grey box” warning that blocks Medicare Part D and Medicaid reimbursements by the Centers for Medicare and Medicaid Services.
“The improved reporting, testing and enforcement regulation would work together to produce a more layered range of regulatory responses,” the authors write. “The FDA, armed with better information about the extent of off-label use and adverse effects, would be in a better position to require post-market testing and to discourage off-label use with new types of warnings if manufacturers fail to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.”
Disclosure of the financial relationships between the medical industry and health care providers is a very important step toward transparency. Patients heavily rely on the recommendations of their doctors to make any kind of decision regarding their health and thus should have full awareness of payments between their doctors and the medical industry. Patients have a right to be informed about possible conflicts of interests.
A not so well-known provision of the Affordable Care Act is the Sunshine Act. The purpose of this act is to increase the transparency in the health care market by requiring doctors, hospitals, pharmaceutical companies, and medical device manufacturers to disclose their financial relationships. Mandated by the Sunshine Act, on September 30th, Centers for Medicare and Medicaid Services (CMS) publicly released the first set of data, under the Open Payments title. This data includes $3.5 billion paid to over half a million doctors and teaching hospitals in the last five months of 2013.
A subset of Open Payments data that is individually identifiable includes two categories of payments. The first category are the payments that are made for other reasons such as travel reimbursement, royalties, speaking and consulting fees and the second are payments which are made as research grants. These datasets together include more than 2.3 million financial transactions which amount to a total of more than $825 million.
Total Payments by Manufacturers of Drugs, Medical Devices, and Biologicals
General Payments
Teaching hospitals and physicians together received $669,561,563 in general payments from 949 different medical manufacturers. Interestingly, close to 70 percent ($460,369,403) of this amount was paid to individual physicians and the rest was paid to teaching hospitals. More than half of the total general payments were made by only 20 companies led by Genentech, which paid $130,065,012 in general grants to various hospitals and doctors and in particular, City of Hope National Medical Center.
Research Payments
Two hundred and ninety-four manufacturers awarded 23,225 research grants to teaching hospitals and physicians. The total value of these grants was $155,815,828. About 70 percent ($107,969,961) of these grants were awarded to teaching hospitals and the rest were awarded to physicians. The top 20 manufacturers contributed more than 75 percent of the total value of these grants. By awarding $17,973,563 in research grants Bristol-Myers Squibb, leads the pack.
The following chart breaks down the payments of the top 20 most generous manufacturers of drugs, medical devices and biologicals to teaching hospitals and individual physicians.
Not surprisingly, the release of the payments data was not immune from criticism. The harshest ones were from the American Medical Association (AMA). In particular, the AMA cited “inadequate opportunity for physician review” and “inaccuracy of the data” as the main problems with the release of open payments data. Moreover, AMA was so concerned about the “misinterpretation” of the data that it released an official “Guide for Media Reporting” in which it “strongly encourage[s] members of the media to… help the public understand the important role that appropriate relationships between physicians and industry has in advancing the practice of medicine.”
Montreal, February 4, 2014 — By 2018, it is estimated that the global pharmaceutical market will be worth more than $1.3 trillion USD. To corner their share of profits, established drug companies have to fight fierce competition from generic products, adhere to stringent government regulations and sway a consumer base that is better informed than ever before.
New research from Concordia University’s John Molson School of Business shows that Big Pharma has begun these efforts by embracing “brand personality,” a marketing strategy traditionally employed by consumer-focused companies like Apple, Coca-Cola and Harley-Davidson.
By imbuing their brands with human characteristics, pharmaceutical companies can boost sales by developing direct relationships with their consumers. The result: patients are more likely to ask their physician to prescribe specific brand-name medication.
“Brand personalities can transform products from being merely functional to having emotional value in the eyes of the consumer,” says marketing professor Lea Katsanis, a co-author of the study that recently appeared in the Journal of Consumer Marketing.
“Pharmaceutical companies give their brands personality traits by relying on physical attributes, practical functions, user imagery and usage contexts. As a result, brand names like Viagra, Lipitor and Prozac become shorthand for the drugs themselves.”
To carry out the study, Katsanis and co-author Erica Leonard, a recent graduate of Concordia’s Master of Science in Marketing program, used an online survey to poll a total of 483 U.S. respondents. They rated 15 well-known prescription medications based on 22 different personality traits, such as dependability, optimism, anxiousness and elegance. The study included blockbuster drugs from Big Pharma companies such as Pfizer, Eli Lilly and GlaxoSmithKline.
The results show that prescription drug brand personality, as perceived by consumers, has two distinct dimensions: competence and innovativeness. Consumers typically applied terms such as dependable, reliable, responsible, successful, stable, practical and solution-oriented” to branded drugs, thus showing a preference for overall competence. Words like unique, innovative and original related to the “innovativeness” of the drug in question.
“Our findings can help marketers better understand how competing brands are positioned and act accordingly to ensure their products remain distinctive. One way of achieving this could be to appropriately focus more on either the competence or innovativeness dimensions,” says Katsanis.
“From a consumer perspective, prescription drug brand personality may make health-related issues more approachable and less intimidating, facilitating physician-patient interactions by making patients more familiar with the medications used to treat what ails them.”
In the 1970s, a Baltimore city senator who also owned a tavern backed legislation that helped his business. Accused of having a conflict of interest, Joseph J. Staszak, responded, “What conflict of interest? How does this conflict with my interest?” [1].
According to the Institute of Medicine, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence” [2]. More simply, conflicts of interest may be seen as circumstances in which “individuals’ professional responsibilities diverge from their personal interests (or when different professional responsibilities clash)” [3].
In biomedicine, discourse on conflicts of interest (also called competing interests) has focused on relationships between industry and physicians or clinical researchers. However, basic scientists are not immune to industry influence on research and publications, and may be important to industry in the production and dissemination of marketing messages.
Depending on Industry
In 2007, industry was the largest funder of biomedical research, paying for nearly twice as much research (58%) as the federal government (33%) [4]. Most of this funding goes to clinical research; the share of spending by pharmaceutical and device industry on preclinical research has decreased from about half (55%) in 1998 to a quarter (25%) in 2010 [5]. A 2007 survey of 3,080 academic life science researchers found that half (53%) have some form of relationship with industry [6]. Among the 1,663 research faculty at academic medical centers, 42% of basic scientists had a relationship with industry. This number was similar to health services researchers/clinical epidemiologists (40%), but less than clinical researchers (67%) translational researchers (61%), or “multimodal” researchers (71%) [7]. At the 50 universities that received the most NIH research funding, 43% of 2,167 life science researchers reported receiving a research-related gift in the late 1990s [8]. Gifts included biomaterials (24% of respondents), discretionary funds (15%), equipment (11%), travel funds to professional meetings (11%), student support (9%), and other (3%).
Researchers were aware that something was expected in return for the gift. Sponsor expectations that the gift be used for its intended purpose and not be re-gifted, and that the sponsor be acknowledged in publications, are certainly reasonable. Disturbingly, however, about a third (32%) of gift recipients reported that the funder wanted prepublication review of any articles or reports stemming from the use of the gift. This expectation was higher for gifts of biomaterials: 40% of respondents reported that the firm wanted to receive prepublication review of articles or reports. Also, 44% of firms wanted assurances that the biomaterial was not to be used for applications that competed with company products [8].
Industry Funding Affects Results
In clinical research, investigators who receive industry funding are more likely to publish results that favor a sponsor’s marketing goals than are investigators who do not receive industry funding. The Cochrane Collaboration, renowned for creating and publishing high-quality systematic reviews, analyzed 48 clinical studies, systematic reviews, and meta-analyses that compared results from studies of drugs or medical devices based on sponsorship. This systematic review found that industry-sponsored studies, compared to non-industry-sponsored studies, were more likely to report favorable efficacy results for drugs or medical devices; less likely to find harms; and more likely to conclude that a therapy was beneficial [9].
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Selective Publication
Selective presentations and publications are important tactics for industry. Industry relies on abstracts and posters to convey marketing messages at scientific meetings, because abstracts and posters are usually not peer-reviewed and can be easily altered up to the time of presentation. Posters and abstracts are often used for preclinical studies, case reports, or preliminary results of clinical trials. Promising preliminary results might be presented as a poster, and the results may be publicized, but if the final results of the study do not support commercial goals, the full study may never be published – or may be buried in an obscure, low-impact journal. In either case, scientists may have a positive impression of a therapy from a poster, and never learn that the therapy failed to show efficacy in the final study.
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Perhaps because negative outcomes from industry-funded studies are less likely to be submitted for publication, industry-funded clinical trials overall are less likely to be published. An analysis of 546 drug trials listed in ClinicalTrials.gov found that within two years of study completion, about a third of studies that received full (32%) or partial (39%) industry support were published. In contrast, more than half (54%) of trials funded by government, and 56% of trials funded entirely through nonprofit/nonfederal funds, were published [19].
The majority of meeting abstracts and posters are never published. Posters and abstracts with positive results are far more likely to be published than negative studies [14],[15].
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Once a drug is on the market, it can be prescribed “off-label” – that is, for any condition other than that for which the drug was approved. Although it is legal for physicians and other prescribers to prescribe a drug off-label, it is illegal for pharmaceutical companies to promote drugs off-label. Off-label use is common, accounting for about one in five prescriptions [23]. It is unknown how much off-label use is due to promotion.
Pharmaceutical companies use paid speakers, consultants, and researchers to promote off-label use [24].
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Companies have paid billions of dollars in fines for off-label promotion, often using company-generated research, company-paid speakers, and ghostwritten articles to imply clinical benefits in the absence of clinical trials (or the presence of negative trials); fines have also been imposed for suppressing risks or misleading clinicians about risks [34].
FDA’s Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program’s goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency: e-mail BadAd@fda.gov or call 855-RX-BADAD.
Continuing Medical Education Video itself is free for anyone to view (http://www.sigmatech.com/BadAd/courses/index.htm)It covers what is legal/illegal for pharmaceutical companies and their representatives when advertising their products at different venues
Prescription drug advertising must:
Be accurate
Balance the risk and benefit information
Be consistent with the prescribing information approved by FDA
Only include information that is supported by strong evidence
What types of promotion does OPDP regulate?
TV and radio advertisements
All written or printed prescription drug promotional materials
Speaker program presentations
Sales representative presentations
OPDP does not regulate promotion of:
Over-the-Counter Drugs
Dietary Supplements
Medical Devices
Common Violations:
Omitting or downplaying of risk
Overstating the effectiveness
Promoting Uses Not Addressed in Approved Labeling
Misleading drug comparisons
Examples of Violations
Example of Omission of Risk
You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.
Example of Uses Not Addressed in Approved Labeling You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.
This presentation would be illegal because it promotes an unapproved use.
Example of Overstating the Effectiveness
“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”
This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.
Frequently Asked Questions
1. Can I report anonymously?
Yes, anonymous complaints often alert FDA to potential problems. However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.
2. Will OPDP be able to stop the misleading promotion?
In many cases, yes, especially if the appropriate evidence is provided. Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.
3. What will happen to my complaint once I have contacted OPDP?
The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs. The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.
4. How do I learn more?
To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.
This blog presents a sampling of health and medical news and resources for all. Selected articles and resources will hopefully be of general interest but will also encourage further reading through posted references and other links. Currently I am focusing on public health, basic and applied research and very broadly on disease and healthy lifestyle topics.
Several times a month I will post items on international and global health issues. My Peace Corps Liberia experience (1980-81) has formed me as a global citizen in many ways and has challenged me to think of health and other topics in a more holistic manner.
Do you have an informational question in the health/medical area? Email me at jmflahiff@yahoo.com I will reply within 48 hours.
My professional work experience and education includes over 15 years experience as a medical librarian and a Master’s in Library Science. In my most recent position I enjoyed contributing to our library’s blog, performing in depth literature searches, and collaborating with faculty, staff, students, and the general public.
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