Health and Medical News and Resources

General interest items edited by Janice Flahiff

[News release] Credibility of Evidence: A Reconsideration of the Logic and Strength of Our Healthcare Decisions

From the 22 May 2015 HealthCare Blog post

A few days ago, we wrote an editorial for US News and World Reports on the scant or dubious evidence used to support some healthcare policies (the editorial is reproduced in full below).  In that case, we focused on studies and CMS statements about a select group of Accountable Care Organizations and their cost savings. Our larger point however is about the need to reconsider the evidence we use for all healthcare-related decisions and policies. We argue that an understanding of research design and the realities of measurement in complex settings should make us both skeptical and humbled.  Let’s focus on two consistent distortions.

Screen Shot 2015-05-23 at 5.27.07 AM

Evidence-based Medicine (EBM).  Few are opposed to evidence-based medicine.  What’s the alternative? Ignorance-based medicine? Hunches?  However, the real world applicability of evidence-based medicine (EBM) is frequently overstated. Our ideal research model is the randomized controlled trial, where studies are conducted with carefully selected samples of patients to observe the effects of the medicine or treatment without additional interference from other conditions. Unfortunately, this model differs from actual medical practice because hospitals and doctors’ waiting rooms are full of elderly patients suffering from several co-morbidities and taking about  12 to 14 medications, (some unknown to us). It is often a great leap to apply findings from a study under “ideal conditions” to the fragile patient. So wise physicians balance the “scientific findings” with the several vulnerabilities and other factors of real patients.  Clinicians are obliged to constantly deal with these messy tradeoffs, and the utility of evidence-based findings is mitigated by the complex challenges of the sick patients, multiple medications taken, and massive unknowns. This mix of research with the messy reality of medical and hospital practice means that evidence, even if available, is often not fully applicable. 

Relative vs. Absolute Drug Efficacy:

Let’s talk a tiny bit about arithmetic. Say we have a medication (called X) that works satisfactorily for 16 out of a hundred cases, i.e., 16% of the time.  Not great, but not atypical of many medications.  Say then that another drug company has another medication (called “Newbe”) that works satisfactorily 19% of the time. Not a dramatic improvement, but a tad more helpful (ignoring how well it works, how much it costs, and if there are worse side effects).  But what does the advertisement for drug “Newbe” say?   That “Newbe” is almost 20% better than drug “X.” Honest. And it’s not a total lie.  Three percent (the difference between 16% and 19%) is 18.75%, close enough to 20% to make the claim legit. Now, if “Newbe” were advertised as 3% better (but a lot more expensive) sales would probably not skyrocket. But at close to 20% better, who could resist?   

Policy:  So what does this have to do with healthcare policy?  We also want evidence of efficacy with healthcare policies but it turns out that evaluation of these interventions and policies is often harder to do well than are studies of drugs. Interventions and policies are introduced into messy pluralistic systems, with imprecise measures of quality and costs, with sick and not-so-sick patients, with differing resources and populations, with a range of payment systems, and so on and so on. Sometimes, randomized controlled trials are impossible.  But sometimes they are possible but difficult to effect. Nevertheless, we argue they are usually worth the effort. Considering the billions or trillions of dollars involved in some policies (e.g., Medicare changes, insurance rules) the cost is comparatively trivial.

But there’s another question: What if a decent research design is used to measure the effects of a large policy in a select population but all you get is a tiny “effect?”  What do we know? What should policymakers do? Here’s what we wrote in our recent editorial in the US News and World Report….

 

Advertisements

May 23, 2015 Posted by | health care | , , , , , , , , , , , | Leave a comment

[Press release] Top 10 challenges facing global pharmaceutical supply chains

English: Value, supply and demand chains

English: Value, supply and demand chains (Photo credit: Wikipedia)

 

 

 

 

 

From the 2 February 2015 New York University press release

Ten years after the 2005 Paris Declaration on Aid Effectiveness reported on the need for better coordination in the global fight against disease, global pharmaceutical supply chains remain fragmented and lack coordination, facing at least 10 fundamental challenges, according to a newly published paper by professors at NYU Wagner and MIT-Zaragoza.

“Heroes may win battles, but it is capable supply chains that win wars [against disease],” write Natalie Privett, assistant professor of management and policy at the Robert F. Wagner Graduate School of Public Service at New York University, and David Gonsalvez, professor of supply chain management at the MIT-Zaragova International Logistics Program, and former global supply chain director with General Motors. Yet, they add, the global health pharmaceutical delivery (GHPD) supply chains are wanting.

The research article, entitled “The top ten global health supply chain issues: Perspectives form the field,” has been published in Operations Research for Health Care, an academic journal. It sheds light on the key areas of weakness and what specifically is needed to strengthen the pharmaceutical supply chains.

Privett and Gonsalvez interviewed and surveyed 22 individuals with various roles in supply chains and asked them to identify the “top ten” challenges as they see them. The areas of concern which were most often cited include: lack of coordination; inventory management; absent demand information; human resource dependency; order management; shortage avoidance; expiration; warehouse management; temperature control; and shipment visibility.

“Lack of coordination in the GHPD supply chain is a root cause issue whose existence aggravates nearly every other issue director or indirectly,” according to the article.

The paper draws attention to both the needs and opportunities in GHPD supply chains in an attempt to “drive future actions, policies, and research which can ultimately improve pharmaceutical delivery in developing regions and save lives.”

To read the article, please visit:http://www.sciencedirect.com/science/article/pii/S2211692314200002.

 

February 3, 2015 Posted by | Public Health | , , , , , , , | Leave a comment

DocuBase Article: Trading Away Access to Medicines – Revisited

DocuBase Article: Trading Away Access to Medicines – Revisited.

From the abstract

Tuesday, 13th January 2015
Trading Away Access to Medicines – Revisited
Source: Oxfam International

Screen Shot 2015-01-23 at 12.29.50 PM

From Summary:

The failure of the current pharmaceutical research and development (R&D) system is revealed by the World Health Organization (WHO) alert about the lack of effective medicines to address antimicrobial resistance, and the absence of a treatment for the deadly Ebola virus that is ravaging communities in West Africa at the time of writing.

While low- and middle-income countries (LMICs) have being suffering from a lack of access to medicines for years, European public health systems have become unable to bear the burden of expensive new medicines. The rise of non-communicable diseases (NCDs) is affecting all people, but is more acutely hitting developing countries that are still struggling with the unfinished business of communicable diseases. Meanwhile, European health systems, badly hit by austerity measures, are under pressure to deliver more with less money, against a backdrop of rising medicine prices.

The European Union (EU) could play a leading role in improving pharmaceutical innovation and access to medicines around the world. However, the European Commission (EC) has implemented a trade agenda that favours the commercial interests of the multinational pharmaceutical industry over the health of people in LMICs. Such trade policies have triggered an outcry from European citizens, experts and organizations, who are asking for the public interest to be prioritized in trade discussions.

Opening statement
Screen Shot 2015-01-23 at 12.31.24 PM

January 23, 2015 Posted by | health care | , , , , | Leave a comment

[Brookings Report] Pharma Pays $825 Million to Doctors and Hospitals, ACA’s Sunshine Act Reveals | Full Text Reports…

Pharma Pays $825 Million to Doctors and Hospitals, ACA’s Sunshine Act Reveals 

From the report

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.”

November 28, 2014 Posted by | Medical and Health Research News | , , , , , , | Leave a comment

[News article] Corruption of health care delivery system? — ScienceDaily

Corruption of health care delivery system? — ScienceDaily.

From the 14 October 2014 article

he foundation of evidence-based research has eroded and the trend must be reversed so patients and clinicians can make wise shared decisions about their health, say Dartmouth researchers in the journal Circulation: Cardiovascular Quality and Outcomes.

Drs. Glyn Elwyn and Elliott Fisher of The Dartmouth Institute for Health Policy & Clinical Practice are authors of the report in which they highlight five major problems set against a backdrop of “obvious corruption.” There is a dearth of transparent research and a low quality of evidence synthesis. The difficulty of obtaining research funding for comparative effectiveness studies is directly related to the prominence of industry-supported trials: “finance dictates the activity.”

The pharmaceutical industry has influenced medical research in its favor by selective reporting, targeted educational efforts, and incentivizing prescriber behavior that influences how medicine is practiced, the researchers say. The pharmaceutical industry has also spent billions of dollars in direct-to-consumer advertising and has created new disease labels, so-called disease-mongering, and by promoting the use of drugs to address spurious predictions.

Another problem with such studies is publication bias, where results of trials that fail to demonstrate an effect remain unpublished, but trials where the results are demonstrated are quickly published and promoted.

English: Example of promotional "freebies...

English: Example of promotional “freebies” given to physicians by pharmaceutical companies (Photo credit: Wikipedia)

 

The authors offer possible solutions:

October 17, 2014 Posted by | health care | , , , , , , , , , , | Leave a comment

[News Article] The Steep cost of Life Saving Drugs

Medication Health News

ID-10057221 With many new drugs being brought to market, there has been increased talk about the pricing of many agents. Today, drugs in question include Evzio, a new naloxone auto-injector and  Sovaldi, a new antiviral for hepatitis C. These agents could save many lives, but their potential high costs could be a barrier to many of the patients of need. How should we solve this dilemma?  Should the subsidies be provided to those in need of these therapies?  What are your thoughts?

For additional information, please see the news analysis in the New York Times.

Image courtesy of [ddpavumba]/FreeDigitalPhotos.Net

View original post

May 2, 2014 Posted by | health care | , , , | Leave a comment

Drugs For Life; Subcultural Identity

The Kente Weaver

Watch: http://www.bbc.co.uk/programmes/b01r0h4r

BY: BBC Video Documentary, Think Aloud.

Here’s a short video interview with anthropologist Joseph Dummit, author of the book “Drugs For Life” in which he tackles  the pervasiveness of America’s pharmaceutical market in its economy and society. Dummit explores in detail, America’s increasing medicalization and the emergence of the ‘expert patient’ who shifts the dynamic of the patient-doctor relationship because this ‘expert patient’ is now equipped with ‘knowledge’ about his own health, what kind of lifestyle is healthy and to some extent the ‘medical know-how’ of how to treat certain conditions ‘off-the-counter’.

Dummit argues that Pharmaceutical companies have come to occupy a predominant role in American society, changing the discourse about what is “healthy” and what isn’t through their huge marketing campaigns and their capitalistic drive. What I find most interesting in his argument is the fact that he shows how these direct-to-consumer advertising mechanisms not only affect patients…

View original post 390 more words

March 13, 2014 Posted by | health care | , , | Leave a comment

[Press release] Are you big pharma’s new target market?

From the 3 February 2014 EurekAlert

Taking a cue from Apple and Coca-Cola, pharmaceutical firms are humanizing their brands

This news release is available in French.

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.

Screen Shot 2014-02-05 at 8.35.25 AM

“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.”

###

Related links:

 

 

Media contact:

Cléa Desjardins
Senior advisor, media relations
University Communications Services
Concordia University
Phone: 514-848-2424, ext. 5068
Email: clea.desjardins@concordia.ca
Web: concordia.ca/now/media-relations
Twitter: twitter.com/CleaDesjardins

Enhanced by Zemanta

February 5, 2014 Posted by | health care, Health News Items | , , , , | Leave a comment

[Reblog] Last week “clinical trial system broken”; this week “luxury journals distort/damage science”

From the 10 December 2013 HealthNewsReview.org post 

In the BMJ recently:

“The clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak. …

“Drug companies have turned into marketing machines. They’ve kind of lost sight of the fact that they’re actually doing something which involves your health,” Marciniak says. “You’ve got to take away the key components of the trials from drug companies.”

Now, in The Guardian, Nobel Prize winner Randy Schekman writes, “How journals like Nature, Cell and Science are damaging science: The incentives offered by top journals distort science.” Excerpt:

“These luxury journals are supposed to be the epitome of quality, publishing only the best research. Because funding and appointment panels often use place of publication as a proxy for quality of science, appearing in these titles often leads to grants and professorships. But the big journals’ reputations are only partly warranted. While they publish many outstanding papers, they do not publish only outstanding papers. Neither are they the only publishers of outstanding research.

These journals aggressively curate their brands, in ways more conducive to selling subscriptions than to stimulating the most important research.”

And he goes on to state that he will avoid such journals in the future.

“Like many successful researchers, I have published in the big brands, including the papers that won me the Nobel prize for medicine, which I will be honoured to collect tomorrow.. But no longer. I have now committed my lab to avoiding luxury journals, and I encourage others to do likewise.”

Note:  in case you missed it, yesterday I linked to Dr. Richard Lehman’s BMJ journal review blog, in which he wrote:

“The Lancet is a very odd journal, in case you hadn’t noticed. Some weeks it contains pharma-funded phase 2 trials of astounding clinical irrelevance.”

One of my boilerplate slides in talks I give to journalists is the following, cautioning them not to treat journal publications as if they were Moses bringing the stone tablets from the mountaintop to the people.

Addendum on December 11:  The Retraction Watch blog states that Schekman’s “argument isn’t airtight” and that “the picture may be a bit more complicated than his Guardian piece let on.”  Excerpt:

“…just how many retractions have these journals had? And how does that compare to the number in the Proceedings of the National Academy of Sciences (PNAS) while one Randy Schekman was editor? Here’s the 2006-2011 data, analyzed according to Ferric Fang and Arturo Casadevall’s Retraction Index, which calculates the rate of retraction per 1,000 papers published:

Journal

Retractions

Articles

Retraction Index

Impact Factor

Science

10

5702

1.754

32.452

Nature

7

5403

1.296

36.235

Cell

11

2899

3.794

34.774

PNAS

23

21614

1.064

10.472

So yes, PNAS had a lower Retraction Index than the other journals, but not really that much lower than Nature. Put another way, however, PNAS retracted 23 papers from 2006 to 2011, while Cell, Nature, and Science retracted 28. And perhaps even more important, there were 1,300 retractions in journals other than those four.

“Wait,” you’re saying, “are more retractions really a bad thing? Didn’t you just publish a post about a study that said the opposite?” Well yes, yes we did. But Schekman is suggesting retractions are a mark against a journal, which we think makes PNAS’s record of retractions fair game.”

 

 

December 16, 2013 Posted by | health care | , , , , , | Leave a comment

[Newspaper article] An effective eye drug is available for $50. But many doctors choose a $2,000 alternative.

From the 7 December 2013 Washington Post article

By  and , Published: December 7

The two drugs have been declared equivalently miraculous. Tested side by side in six major trials, both prevent blindness in a common old-age affliction. Biologically, they are cousins. They’re even made by the same company.

But one holds a clear price advantage.

Avastin costs about $50 per injection.

Lucentis costs about $2,000 per injection.

Doctors choose the more expensive drug more than half a million times every year, a choice that costs the Medicare program, the largest single customer, an extra $1 billion or more annually.

Spending that much may make little sense for a country burdened by ever-
rising health bills, but as is often the case in American health care, there is a certain economic logic: Doctors and drugmakers profit when more-costly treatments are adopted.

Genentech, a division of the Roche Group, makes both products but reaps far more profit when it sells the more expensive drug. Although Lucentis is about 40 times as expensive as Avastin to buy, the cost of producing the two drugs is similar, according to scientists familiar with the drugs and the industry.

Doctors, meanwhile, may benefit when they choose the more expensive drug. Under Medicare repayment rules for drugs given by physicians, they are reimbursed for the average price of the drug plus 6 percent. That means a drug with a higher price may be easier to sell to doctors than a cheaper one. In addition, Genentech offers rebates to doctors who use large volumes of the more expensive drug.

The rising cost of U.S. entitlement programs such as Medicare has prompted outrage in Congress, but it is Congress that has made it difficult in this case and others for Medicare to limit such expenses.

To begin with, the Medicare agency is blocked from seeking better drug prices by negotiating directly with the drug companies, as health agencies in other countries do. Authorities in Britain, for example, have negotiated a price of about $1,100 per dose of Lucentis, and in the Netherlands a dose sells for about $1,300.

Moreover, in cases in which two equivalent options are available, such as Lucentis and Avastin, Medicare is forbidden from restricting payment to the amount of the less costly alternative. After it sought to do so in 2009, a federal appeals court said it lacked that authority.

It’s often difficult, of course, to know when two drugs are equivalent. When the debate over the two drugs and their pricing erupted more than six years ago, Genentech asserted that its more expensive new drug was superior. At the time, it was hard to show otherwise. No one had tested them in side-by-side comparisons.

Since then, the six randomized clinical trials involving more than 3,000 patients have found the drugs to be largely equivalent.

Yet in 2012, the Medicare program and its beneficiaries spent $1.2 billion on Lucentis, according to The Post’s analysis of Medicare data.

Medicare officials said they have no choice but to pay the bill when a doctor prefers to use Lucentis.

 

Read the entire article here

 

December 10, 2013 Posted by | health care | , , , , | Leave a comment

The Cause of the Productivity Crisis in Pharmaceutical R&D; the CBCD Draws Conclusions from a Recent Example

Excerpt from the 15 October 2013 report

The Cause of the Productivity Crisis in Pharmaceutical R&D; the CBCD Draws Conclusions from a Recent Example (PRWeb)

“The pharmaceutical industry is experiencing a productivity crisis in R&D. What is this crisis? First, every year, the pharmaceutical industry is introducing fewer new drugs. Second, a portion of the FDA approved drugs are withdrawn from the market. Third, an analysis of Drugs.com shows that all other FDA approved drugs have many side effects.

What is the source of the productivity crisis?

A compelling explanation is offered in a paper published on March, 2012 in the medical journal Nature Reviews. The paper said that “Much of the pharmaceutical industry’s R&D is now based on the idea that high-affinity binding to a single biological target linked to a disease will lead to medical benefit in humans. Indeed, drug-like small molecules tend to bind promiscuously, and this sometimes turns out to have an important role in their efficacy as well as their so-called off-target effects. Targets are parts of complex networks leading to unpredictable effects, and biological systems show a high degree of redundancy, which could blunt the effects of highly targeted drugs (2).”

In simple terms, the idea that a drug binds with only one target is wishful thinking. As it turns out, every drug binds with many targets in the body, the desired one, and many others. Binding to the ‘other’ targets usually causes all the unwanted, surprising, side effects. [my emphasis]

“The CBCD believes that the current understanding of biology is limited and therefore, the Single Target paradigm is bound to fail.” – Greg Bennett, CBCD” “

 

November 5, 2013 Posted by | health care | , , , , , | Leave a comment

[FDA program aimed at health care providers] Truthful Prescription Drug Advertising and Promotion

This page is geared towards health care providers, but it may be of interest to others.

From the US FDA (Food and Drug Administration) Web page 

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 agencye-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.

November 5, 2013 Posted by | Educational Resources (High School/Early College(, Health Education (General Public), Librarian Resources, Professional Health Care Resources | , , , , , | Leave a comment

Early Benefit Assessment for Pharmaceuticals in Germany: Lessons for Policymakers

From the overview (abstract) at the 16 October 2013 Commonwealth Fund posting

Since 2011, Germany’s Pharmaceutical Market Restructuring Act has mandated that all newly introduced drugs are subject to an assessment of their benefits in relation to a comparator, typically the current standard treatment. For drugs found to have some additional benefit, the manufacturer and the statutory health insurers negotiate a price. For drugs found to have no additional benefit, their price is set in reference to the price of the comparator. This new system is intended to reduce spending on expensive new drugs that are no more effective than existing treatments, while encouraging pharmaceutical companies to invest in innovative drugs that improve health outcomes. The German experience provides lessons for the United States, where comparative effectiveness research is publicly funded but public insurance programs are limited in their ability to use its findings to make coverage or pricing decisions.

Screen Shot 2013-10-22 at 5.39.14 AM

Screen Shot 2013-10-22 at 5.41.22 AM

October 22, 2013 Posted by | health care | , , , | Leave a comment

The wacky world of prescription prior authorizations

English: National Naval Medical Center, Bethes...

English: National Naval Medical Center, Bethesda, Md., (Aug. 19, 2003) — Pharmacist Randal Heller, right, verifies the dosage and medication of a prescription at the National Naval Medical Center in Bethesda, Maryland. Heller checks all prescriptions dispensed at the pharmacy before they are handed over the counter to the patient. Heller is retired as a Commander from the Navy Medical Service Corps. U.S. Navy photo by Chief Warrant Officer 4 Seth Rossman. (RELEASED) (Photo credit: Wikipedia)

Pharmacists are among my favorite professionals.
I’ve always been able to get expert prescription drug related information (as side effects) and OTC advice for free! Even when I wasn’t their customer.

But even they are human and have their customer service pet peeves.
Don’t we all who work with clients, customer, and “the public”.
(Just hope I’m not one of those wacky customers!).

 

From the 26 July 2013 KevinMD article

 | MEDS | JULY 26, 2013

It’s happened at last: the epitome of ridiculousness in the already pretty ridiculous world of drug prior authorizations. I wish I could say that I made this up.

I got a fax from a pharmacy requesting a prior authorization for a brand name drug called Protonix, one of a family of medications used to treat ulcers, acid reflux, and other forms of tummy ache. This happens. Because there are five different drugs in this class (not counting generics), there is no way I can keep straight which plans prefer which drug. Sadly, switching patients from one medication to another, even if it’s working just fine, purely because of which drug maker is in bed with which insurance plan, is an everyday event. No big deal.

Here’s the thing: the patient was already doing well on pantoprazole, which happens to be generic Protonix. What?

The fax from the pharmacy has more information: “The patient wants a prescription for brand name Protonix because she has a coupon that will allow her to pay only $4.00 for it.”

It just so happens that pantoprazole is already on the list of $4.00 generics!

But, says the pharmacy, that’s what the patient wants.

Read the entire article here

July 26, 2013 Posted by | health care | , , , , , , , , , | Leave a comment

[Reblog] Bad Pharma (the book) comes to the US

Bad-Pharma-cover.jpg

 

[Reblog] From the 2 February 2013 post at HealthNewsReview.org

British physician and writer Ben Goldacre is on a North American tour.  His book, “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” is released in the US on February 5. The book has been discussed in The EconomistThe Public Library of Science blogsThe Guardian, and elsewhere. (Addendum one day later:  Carl Elliott also reviewed the book in the BMJ.)

He also has an op-ed in the New York Times, “Health Care’s Trick Coin.”  Excerpt:

“…the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses…. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good. These problems would be bad enough on their own, but they are compounded by a generation of “fake fixes” that have delivered false reassurance, and so prevent realistic public discussion.

The best evidence shows that half of all the clinical trials ever conducted and completed on the treatments in use today have never been published in academic journals. Trials with positive or flattering results, unsurprisingly, are about twice as likely to be published — and this is true for both academic research and industry studies.

If I toss a coin, but hide the result every time it comes up tails, it looks as if I always throw heads. You wouldn’t tolerate that if we were choosing who should go first in a game of pocket billiards, but in medicine, it’s accepted as the norm. In the worst case, we can be misled into believing that ineffective treatments are worth using; more commonly we are misled about the relative merits of competing treatments, exposing patients to inferior ones.”

 

 

February 6, 2013 Posted by | Consumer Health | , , , , | Leave a comment

Trying to keep up with health care ethics (mis)adventures

From http://www.jsonline.com/features/health/drug-company-money-and-the-rise-of-opiod-usage-139609893.html

The 14 May 2012 HealthNewsReview.org post highlights three biomedical ethics items

“…The American Pain Foundation – an industry funded promoter of painkillers masquerading as a patient advocacy organization – closed its doors last week after it became the target of a U.S. Senate panel inquiry.The action by the U.S. Senate Finance Committee and the surprisingly quick collapse of the foundation were prompted by two journalistic investigations:The first was Charles Ornstein’s and Tracy Weber’s Dollars for Doctors series for ProPublica. In The Champion of Painkillers, which ran in December in The Washington Post, they describe how aggressive the American Pain Foundation has been in promoting opioids:..

..The other major journalistic investigation to draw the Senate’s attention was by John Fauber at the Milwaukee Journal Sentinel, working in collaboration with MedPage Today. For several years, Fauber has doggedly covered conflicts of interest in academic medicine, ethical problems, the growth in pain medicine and the resulting rise in painkiller addictions and deaths. As part of his Side Effects series, in February 2012, Fauber wrote about the American Pain Foundation and other groups that promote pain pills: Painkiller boom fueled by networking:”

By Carl Elliott

Let’s start with a quiz.  Can you tell which of these awards is real?

A) The Exxon Valdez Prize in Environmental Ethics

B) The Goldman Sachs Endowment in Business Ethics

C) The Richard Milhous Nixon Award for Ethics in Government

D) The Pfizer Fellowship in Bioethics

If you guessed D), you win. …

  •  “Missing the Target: When Practitioners Harm More Than Heal.
    Two day conference at Georgetown University, June 14-15,  an Adriane Fugh-Berman’s PharmedOut.org event

    Topics Include:

    • “The Underuse of Classic Drugs”
    • “Are Medical Devices and Drugs Adequately Regulated?”
    • “Protecting Patients in Industry-Funded Trials”
    • “Risks of Cardiovascular Devices”
    • “Cancer Risks from CT Scans”
    • “Pharmaceutical Marketing and Adverse Health Outcomes”

     

May 23, 2012 Posted by | health care | , , | Leave a comment

Legal Drug-Pushing: How Disease Mongers Keep Us All Doped Up – John-Manuel Andriote – Health – The Atlantic

daily dose

daily dose (Photo credit: nirbhao)

By manipulating our fear of suffering and death, big pharmaceutical companies are able to keep us coming back for expensive medications

Legal Drug-Pushing: How Disease Mongers Keep Us All Doped Up – John-Manuel Andriote – Health – The Atlantic

Excerpts from this article from the 3 April 2012online edition of The Atlantic

.Pharmaceutical giants, like small-town pizza parlors, have two options for making more money: convince regulars to buy more of what they obviously like, or find ways to persuade more people that they will be happier with this drug or that thin crust with extra cheese.In the case of the drug companies, it’s not our taste buds they’re appealing to. Instead, they market prescription drugs directly to consumers — a practice legal only in the United States and New Zealand — by, basically, manipulating our fear of suffering and death.These “disease mongers” — as science writer Lynne Payer in her 1992 book of that name called the drug industry and the doctors, insurers, and others who comprise its unofficial sales force — spin and toil “to convince essentially well people that they are sick, or slightly sick people that they are very ill.”Changing the metrics for diagnosing a disease is one reliable technique. Dr. Adriane Fugh-Berman, associate professor of pharmacology and director of the industry watchdog group PharmedOut.org at Georgetown University School of Medicine, pointed to how the numbers used to diagnose diabetes and high cholesterol have been lowered over time. “The very numbers we use have been reduced to the point of absurdity,” she said. “120/80 was considered normal blood pressure; now it’s considered ‘pre-hypertension.'”Entirely new diseases can be, and have been, invented to extend a manufacturer’s patent on a highly profitable drug. Fugh-Berman said Eli Lilly stood to lose a lot of profits once the patent expired on its hugely popular antidepressant Prozac. “So they positioned this new condition, PMDD (Pre-Menstrual Dysphoric Disorder), and then went to physicians and the FDA with their highly paid experts who said PMDD is a tragic disease, and they got approved for Sarafem, the same drug. It’s an on-label use for a repackaged drug; they created the disease and then got a drug re-approved that was going off patent.”..

The article goes on to outline one feature of the “medical industrial complex” –  the expansion of disease categories to include precursor conditions as psychosis risk syndrome. These categories are included in professional manuals, making it easier for drug companies to develop and market new drugs associated with conditions recognized by medical associations.

The authors also asks if Americans are being overdiagnosed through an overly medicalized drug culture partly created through aggressive prescription drug advertisements.  Responsibility for addressing this issue is in the hands of consumers, professional health care providers, government regulators, and all who contribute to our culture (as artistis, writers, and journalists).

Read the entire article here.

Related Resources

  • ClinicalTrials.gov -up-to-date information for locating federally  and privately supported clinical trials for a wide range of diseases and  conditions. A clinical trial (also clinical research) is a research study in  human volunteers to answer specific health questions. Interventional trials  determine whether experimental treatments or new ways of using known therapies  are safe and effective under controlled environments.

A growing number of clinical trials publish at least some of their results at ClinicalTrials.gov
Use the Advanced Search and use the Search Results to limit to Studies with Results

  • Cochrane Systematic Reviews
    (Click here for the free summary version)Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.Each systematic review addresses a clearly formulated question; for example: Can antibiotics help in alleviating the symptoms of a sore throat? All the existing primary research on a topic that meets certain criteria is searched for and collated, and then assessed using stringent guidelines, to establish whether or not there is conclusive evidence about a specific treatment. The reviews are updated regularly, ensuring that treatment decisions can be based on the most up-to-date and reliable evidence
  • Drug Information Portal
    A gateway to selected drug information from the US government. It links you to information on over 12,000 drugs from trusted consumer drug information sources (as MedlinePlus Drug Information), the US Food and Drug Information (as Drugs @FDA), LactMed (summary of effects on breastfeeding), and more.
  • Clinically important safety information and reporting serious problems with human medical products.
    Safety information includes drug information, recalls & alerts, drug shortage information, and medication guides.
  • Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products, recalls, advisories, and warnings from the Canadian government
  • Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.
    Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.
  • We should treat diseases not create diseases to treat (medrants.com)
  • Pop. Snort. Parachute.(New York Magazine, 2005))

    To many New York teenagers, all the world’s a pharmacy. There is a vanishing distinction between pills for medication and for recreation, and the much-touted risk of suicide misses the point.By David Amsden Published May 21, 2005

    “….Drug companies, though, have plenty of incentives to market their drugs to kids. Adolescents represent a relatively untapped (but rapidly growing) market for drugmakers, something any successful business looks to exploit. And they’re generally encouraged to do so by the government. A federal law passed in 1997 allows a drug company to keep its patent an extra six months by performing clinical trials on children, which translates into enormous profits. Zoloft, for instance, grossed about $3.1 billon in sales last year, so that additional time is hugely lucrative.

    Meanwhile, the shame associated with psychotropic meds continues to dissipate as doctors write more prescriptions and the diagnosed “disorders” become less severe-sounding. First there was depression, then social-anxiety disorder; now we have general-anxiety disorder, which Xanax’s Website defines as having “vague feelings that something bad is going to happen,” an apt description of what it’s like to be an adolescent. Zoloft’s Website describes social-anxiety disorder as often starting in the “mid-teen” years, and yet the drug’s television ad campaign, with its cartoon powder puffs, looks like a Sesame Streetouttake. And while Pfizer denies targeting kids, teenagers themselves aren’t so sure. “That’s so geared toward children,” Timothy told me. “It’s like, ‘You’re not happy anymore? Here, take some pills and you’ll be appreciating butterflies left and right!’ ”

    “What’s really changed is that now they market medical conditions,” says Marcia Angell, a member of Harvard Medical School’s Department of Social Medicine and author of The Truth About the Drug Companies, the just-published indictment of big pharmaceutical firms. “It’s simple—there will always be more healthy people than sick people, so they need to make more people think they’re sick. Teens are naturally going through an intense period of ups and downs. The marketing makes them think the downs are unacceptable, that they’re a disorder.”

    What such marketing cannot take into account is that kids are cynical, reluctant to take the word of adults at face value. When this attitude mixes with prescription drugs, it turns into a desire to reinvent their intended uses in a manner that’s not necessarily ill-intentioned. Because the taboo truth is that illicit use can be legitimately helpful, which makes the dangers that much easier to overlook….

  • Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results) (jflahiff.wordpress.com)
  • Pharmaceutical Companies Turn to Checklists to Sell More Drugs (labsoftnews.typepad.com)
  • Painkiller sales soar across U.S., spread to new areas (usatoday.com)
  • Tony Bennet Says Legalizing Drugs Could Prevent Deaths Like Whitney Houston’s; Prescription Drugs Aren’t Safer (blisstree.com)
  • The billion-dollar battle over premenstrual disorder (salon.com)

April 5, 2012 Posted by | Uncategorized | , , , | Leave a comment

Current psychiatric drugs are only marginally effective

From a KevinMD.com article by Steve Balt, MD

The scientific journal Nature ran an editorial recently with a rather ominous headline: “Psychopharmacology in Crisis.” What exactly is this “crisis” they speak of?  Is it the fact that our current psychiatric drugs are only marginally effective for many patients?  Is it the fact that they can often cause side effects that some patients complain are worse than the original disease?  No, the “crisis” is that the future of psychopharmacology is in jeopardy, as pharmaceutical companies, university labs, and government funding agencies devote fewer resources to research and development in psychopharmacology.  Whether this represents a true crisis, however, is entirely in the eye of the beholder.

In 2010, the pharmaceutical powerhouses Glaxo SmithKline (GSK) and AstraZeneca closed down R&D units for a variety of CNS disorders, a story that received much attention.  They suspended their research programs because of the high cost of bringing psychiatric drugs to market, the potential for lawsuits related to adverse events, and the heavy regulatory burdens faced by drug companies in the US and Europe.  In response, organizations like the European College of Neuropsychopharmacology (ECNP) and the Institute of Medicine in the US have convened summits to determine how to address this problem.

The “problem,” of course, for pharmaceutical companies is the potential absence of a predictable revenue stream.  Over the last several years, big pharma has found it to be more profitable not to develop novel drugs, but new niches for existing agents—a decision driven by MBAs instead of MDs and PhDs.  As Steve Hyman, NIMH director, told Science magazine last June,  “It’s hardly a rich pipeline.  It suggests a sad dearth of ideas and … lots of attempts at patent extensions and new indications for old drugs.”

Read entire article

July 25, 2011 Posted by | Consumer Health, Public Health | , , , | Leave a comment

   

%d bloggers like this: