FDA ups the Ante on Pharma Ads

As the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

The course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

• GlaxoSmithKline – Paxil, Wellbutrin, Avandia
• Pfizer – Bextra, Geodon, Zyvox and Lyrica
• Johnson & Johnson – Risperdal, Invega, Natrecor, Levaquin, Procrit
• Abbott Laboratories – Depakote
• Eli Lilly – Zyprexa
• Merck – Vioxx
• Serono – Serostim
• Purdue Pharma – OxyContin
• Allergan – Botox
• AstraZeneca – Seroquel
• Bristol-Myers Squibb – Abilify

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

 Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

A Ray of Sunshine?

It’s already 15 months overdue and it will be another year still before the information is public, but last week  the government  set out  the final rule for the Physician Payment Sunshine Act (Sunshine Act) in a 287 page document!

The Sunshine Act (passed in 2010 as part of the Affordable Care Act) requires manufacturers of drugs, devices, biologicals, and medical supplies to report all payments and other transfers of value to physicians and teaching hospitals. The rule was supposed to be published in October 2011, but has suffered continuous delays amongst intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA).

The final rule announced February 1^st, officially puts the Industry on notice. They have until March 2014 to get their payments reporting act together. The U.S. Centers for Medicare and Medicaid Services (CMS), will then input the data, including payment information from August through December of this year, into a publicly available database which, they say, will be online by September 2014.

And its not only payments to doctors of medicine that have to be reported. Under the definitions of the Act, “physicians” include doctors of osteopathy, dentists, podiatrists, optometrists and chiropractors.

The rule also requires reporting on both the form and nature of payment or transfer of value made by a manufacturer to a physician.

Forms of payment included under the final rule :

• Cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
• Any other form of payment or transfer of value

While, nature of payments include:

• Consulting fees
• Compensation for services other than Consulting
• Honoraria
• Gifts
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a Speaker for a medical education program
• Grants
• Any other payment

Advocates of the Sunshine Act have long argued that the public needs to know when doctors are getting paid and by who. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

This increased transparency is also intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. For example, last year an advisory panel voted 15-11 to support the approval of Bayer‘s Yaz birth control pills, but allegations later surfaced that four committee members had ties to the manufacturer.

Once the bill is introduced, doctors will get 45 days after information is submitted to vet it for accuracy.

The American Medical Association (AMA) is not happy.  The doctors’ group wants physicians to have more than 45 days to challenge information in the government’s database and add commentary to explain the payments. It also wants some corporate contributions to physicians excluded from disclosure, including sponsorships for educational activities and “indirect” payments, such as unsolicited contributions a company might make to a nonprofit group affiliated with doctors or to physicians’ employers or practices.

AMA president Jeremy Lazarus wants to ensure “the registries will provide a meaningful and accurate picture of physician-industry interactions. It is critical that the final rule provide physicians with a clear way to correct any inaccurate information and not place any substantial administrative burden on physician practices.”

And the AMA is not alone. Unsurprisingly, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary lobbying group for drugmakers, said that while it supports more disclosure, the new regulations should take into account the importance of context in the publication of physician payment information.

“Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust,” said Matthew Bennett, a spokesman for PhRMA. The principle behind the so-called sunshine provision “is complementary to this belief and it has great potential for helping patients understand the ways in which such collaboration benefits their health and medical innovation,”

What’s your take on this new rule? Is the government helping to let the sun shine in or is this a dark, dark day for doctors and pharma?  Let us know your thoughts.

Does Your Doctor ‘Get You’?

Does your doctor understand you? Does he (or she) know what you’re thinking? Does he really feel your pain? In short, does he care?

Seems this is something you should really care about. According to a study just published in Academic Medicine, patients of doctors who are more empathic have better outcomes and fewer complications.

Researchers from Thomas Jefferson University together with a team from Parma, Italy evaluated relationships between physician empathy and clinical outcomes among 20,961 Italian diabetic patients and their 242 physicians.

The study was a follow up to a smaller one undertaken at Thomas Jefferson University that included 891 diabetic patients and 29 physicians, and showed that patients of physicians with high empathy scores had better clinical outcomes than patients of other physicians with lower scores.

“This new, large-scale research study has confirmed that empathic physician-patient relationships is an important factor in positive outcomes,” said Mohammadreza Hojat, Ph.D., Research Professor in the Department of Psychiatry and Human Behavior and the Director of Jefferson Longitudinal Study at the Center.  “It takes our hypothesis one step further. Compared to our initial study, it has a much larger number of patients and physicians, a different, tangible clinical outcome, hospital admission for acute metabolic complications, and a cross-cultural feature that will allow for generalization of the findings in different cultures, and different health care systems.”

The Italian researchers used the Jefferson Scale of Empathy (JSE) –an instrument used to measure empathy in the context of medical education and patient care. The JSE includes 20 items answered on a seven-point scale (strongly agree = 7, strongly disagree = 1) and measures understanding of patient’s concerns, pain, and suffering, and an intention to help.

The primary outcome measure of the study was acute metabolic complications, including hyperosmolar state, diabetic ketoacidosis, and diabetic coma. These were used because they require hospitalization, can develop quickly, and their prevention is more likely to be influenced by the primary care physicians.

A total of 123 patients were hospitalized because of such complications. Physicians with higher empathy levels had 29 : 7,224 patients admitted to the hospital, whereas physicians with lower levels had 42 : 6,434 patients admitted.

There are many factors that add to the strength of the study. Firstly, because of universal health care coverage in Italy, there is no confounding effect of difference in insurance, lack of insurance or financial barriers to access care.

“What’s more, this study was conducted in a health care system in which all residents enroll with a primary care physician resulting in a better defined relationship between the patients and their primary care physicians than what exists in the United States,” said co-author Daniel Z. Louis.

According to the Centers for Disease Control and Prevention, over 25 million people in the U.S. population have been diagnosed with diabetes, with almost 700,000 hospitalizations per year. There are approximately 2 million new cases per year. Worldwide, the number of total cases jumps to 180 million.

“Results of this study confirmed our hypothesis that a validated measure of physician empathy is significantly associated with the incidence of acute metabolic complications in diabetic patients, and provide the much-needed, additional empirical support for the beneficial effects of empathy in patient care” said Dr. Hojat. “These findings also support the recommendations of such professional organizations as the Association of American Medical Colleges and the American Board of Internal Medicine of the importance of assessing and enhancing empathic skills in undergraduate and graduate medical education.”

Does your doctor get you? Let us know.

FDA Ad Study: Clarifying the Confusion

As a public health agency, the FDA encourages the communication of accurate health messages about medical conditions and treatment.  One way the pharma industry does this is through non-branded disease awareness communications. These are aimed at either the general public or health care practitioners and discuss a particular disease or health condition, without making mention of any specific drug.  Usually, they encourage consumers to seek, and health care practitioners to provide, appropriate treatment for the particular disease state.

This is helpful for under-diagnosed and under-treated diseases such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Some research has shown that consumers prefer disease awareness advertising. It’s considered more informative and less persuasive than full product advertising.

The pharma industry likes it too.  Disease awareness communications are not subject to the regulations and restrictions mandated by the FDA for prescription drug advertising.

But now, the FDA is concerned that disease awareness ads might confuse consumers. According to a Federal Register notice issued on June 20, the agency wants to know whether the public can distinguish between product claims and disease information, and how different types of information impact comprehension.

So worried in fact,  the Agency has planned a study entitled, “Experimental Study: Disease Information in Branded Promotional Material” to look into those questions.

The study will examine print ads for three conditions – COPD, lymphoma and anemia.

4,650 American adults will be divided into three groups and asked to review the ads electronically.

• One group will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address i.e.  “Diabetes is a disease in which blood sugar can vary uncontrollably, leading to uncomfortable episodes of high or low blood sugar.”
• Other participants will see disease information that mentions consequences of the disease that go beyond the indication of the advertised product, such as, “Untreated diabetes can lead to blindness, amputation, and, in some cases, death.”
• A third group will see drug product information only.

Disease information will be presented in different ways. For example, on alternating paragraphs, on separate pages or in different fonts and colors from product claims.

Specifically the study will address whether or not consumers are able to distinguish between claims made for a medication and general disease information when they see an advertisement for a drug.  For example, if an ad for a drug that lowers blood glucose, mentions diabetic retinopathy do consumers  think the drug will prevent the affliction, even if no direct claim is made?

The Agency says: “If consumers are able to distinguish between disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences.”

SRxA’s Word on Health looks forward to seeing the results. Given that warning letters have been issued in the past over ads that contain mixed messages, this is an opportunity for the FDA to revisit its stance toward such advertising, reduce consumer confusion and, most importantly, learn how best to disseminate useful health information.

Abbott Gets a Shellacking

Last week, the street.com -a leading online provider of financial news, commentary, analysis, ratings, business and investment content- took a major swipe at Big Pharma, in general, and Abbott, in particular. Under the headline ‘Abbott Helps Big Pharma Look Even Worse’ author Vince Crew, lambasts the drugmaker for its past marketing practices and warns that unless Pharma adheres to a zero tolerance policy for illegal practices, the industry’s reputation will be doomed forever. Here’s a verbatim copy of what he had to say – “On May 7, Abbott reached an agreement with the federal and nearly all state governments to pay $1.6 billion in connection with its illegal marketing of the anti-seizure drug Depakote.

And yes, it’s even more despicable because it represents the unfortunate, illegal, unethical, typical temptation of off-label marketing — promoting a product for usage contrary to its approval.

Someone(s) at Abbott thought it a good idea, according to the Justice Department confirmation, to have a “specialized sales force” market Depakote in nursing homes to dementia patients, even though there was no evidence that it was safe and effective for such use. By the way, in the spirit of “someone will always tell,” several employees blew the whistle on the pharma behemoth. No doubt the settlement has caused Abbott investors, stakeholders, competitors and the industry in general, to pause. Before you think Abbott is doomed because of a reprehensible thing like this, 11 days following this settlement, Abbott Laboratories reported better-than-expected earnings as sales surged on its injectable arthritis drug, Humira. So, no tears for Abbott, unless they regard ongoing settlements as business as usual and don’t actively adhere to a zero tolerance policy for illegal practices. In that case, we should weep for the industry as a whole. Time will tell.”

Abbott, has a very different story to tell. In their mia culpa press release regarding the settlement, Laura J Schumacher, Executive Vice President, General Counsel and Secretary says, “The company takes its responsibilities to patients and healthcare providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements.” As Mr. Crew says, time will indeed tell. However, everyone would do well to heed the warning. According to Deputy Attorney General James M. Cole, “Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud. We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

In the meantime, if any pharmaceutical companies are looking for help to ensure that their marketing practices are compliant, please remember SRxA is here to help.

A Question of Health

As we’ve said before, and will doubtless say again – the more patients become more actively involved in their own health, the better the outcome.

So we were pleased to learn of a new public education initiative from the U.S. Agency for Healthcare Research and Quality (AHRQ), which encourages patients to have more effective two-way communication with their doctors and other clinicians.

The “Questions are the Answer,” campaign features a website packed with helpful advice and free educational tools for doctors and patients. Among the offerings:

• A 7-minute video featuring real-life patients and clinicians who give firsthand accounts on the importance of asking questions and sharing information. The video has been designed for use in a patient waiting room area and can be set to run on a continuous loop
• A brochure, titled “Be More Involved in Your Health Care: Tips for Patients,” that offers helpful suggestions to follow before, during and after a medical visit
• Notepads to help patients prioritize the top three questions they wish to ask during their medical appointment.

In addition, the site has a series of patient and clinician videos in showing how simple questions can help you take better care of yourself, feel better, and get the right care at the right time. In one of these, Rachelle Toman, M.D., Ph.D., a family physician from Washington D.C., says if you are happy to ask your doctor and grocery store clerk a question, then why not your healthcare provider?

“Patients need to come forth with questions, and providers need to be open about asking their patients questions, and asking their patients to ask questions,” she continues.

Put simply, questions allow doctors to take better care of you.

Are you ready to become an active member of your health care team and get your questions answered?

Drugs That Can Land You in the Emergency Room

It’s midnight at the fire station and a call goes out for a patient who has overdosed. In addition to an ambulance and medic unit, police are dispatched.  As we stage for the police, to ensure that the scene is safe, we speculate as to what we’re going to encounter. Will the patient be conscious? What sort of emotional distress has driven them to this? Is it a serious attempt or a cry for help?  Will there be weapons?

As we mentally run through all types of scenarios, it’s doubtful that many of us have considered that our patient will be an 82 year old great grandmother armed with nothing more than her reading glasses and the remote control.

But increasingly that’s what we might find.  As Americans live longer, we have an increasingly frail population suffering from a greater number of chronic conditions, taking more medications than ever before. Among adults 65 years of age or older, 40% take 5 – 9 medications and 18% take 10 or more.

This type of polypharmacy is associated with an increased risk of adverse events. Older adults are nearly seven times as likely as younger persons to have adverse drug events that require hospitalization.

According to a recent article in the New England Journal of Medicine blood thinners and diabetes drugs cause most of the unintentional overdoses that lead to emergency hospitalization in older patients.

Researchers reviewed the records of 100,000 hospitalization events due to major drug side effects in people aged 65 and above from a representative sample of 58 hospitals.  Almost half, (48%) of adverse drug event (ADE)-related hospitalizations occurred in patients older than 80.

The drugs they looked at included prescription and over-the-counter medications, vaccines, and dietary supplements.

Adverse events were categorized as allergic reactions, undesirable pharmacologic or idiosyncratic effects at recommended doses, or unintentional overdoses.  Other effects included problems due to medication-delivery methods (e.g., choking) and vaccine reactions. Visits for intentional self-harm, drug abuse, therapeutic failures, and drug withdrawal were excluded.

Shockingly, just four medications accounted for more than two-thirds of emergency hospitalizations:

• warfarin (a blood thinner to prevent clots) – 33%
• oral antiplatelet agents (for heart attack prevention) – 13.3%
• insulin (for diabetes) – 13.9%
• oral hypoglycemic agents (for diabetes) -10.7%

Given that emergency hospitalizations caused by ADEs result in significant morbidity and enormous costs it’s not surprising that decreasing harm to patients and reducing costs by preventing re hospitalizations is a goal of the $1 billion federal initiative Partnership for Patients.

Achieving a 20% reduction by the end of 2013 may sound ambitious, but in fact there are a number of simple steps that we can take.

1. Make sure that everyone taking medications has an up-to-date list, including all prescribed drugs as well as vitamins, herbs, and OTC medicines. Copies of the list should be kept in their wallet and should be shared with all doctors they see so that the potential for drug interactions can be assessed and avoided.
2. Alert your loved ones that blood thinners and diabetic medicines account for 50% of hospitalizations due to ADEs. Blood thinners and diabetes medications should be regularly monitored by the primary care physician.
3. Encouraging medication compliance can lengthen a person’s lifespan. Too many times patients stop their medications due to a comment made by a well-meaning friend who has  read something on the Internet. Often the doctor is not informed and the patient may not understand the positive effects of the medication or the dangers of stopping them suddenly.

These small measures may not only save the life of your elderly loved-ones, but they may also  reduce your Word on Health bloggers’ middle of the night 911 dispatches.

Improving Inhaler Instruction

Many of us have never been properly trained on how to do or use certain things we really should be good at. Putting on condoms and wearing seat belts are just two that come to mind.  And when we get them wrong, the health consequences can be serious.

The same goes for asthma inhaler use.  Do you shake the device first? Did you breathe in with sufficient force? Did you press the canister at the right time?

Improper use of inhalers is a serious and expensive problem. In the US, 3 patients are admitted to the emergency room with asthma every minute, that’s >5,000 people a day!  Worse still, according to the Asthma and Allergy Foundation of America, 11 people die from asthma every day.

One study estimated up to 94% of patients use their inhalers incorrectly.  The most common mistakes include failure to exhale before actuation, failure to breath-hold after inhalation, incorrect positioning of the inhaler, incorrect rotation sequence, and failure to execute a forceful and deep inhalation. Those of us in healthcare have even seen patients who fail to take the cap off the inhaler before use, and others who use it nasally rather than orally.

This is hardly surprising given that many patients never receive instructions on how to use their inhalers and even those that do, are not routinely followed.  And let’s face it, some of these devices could use training wheels.

Enter the T-Haler, a digital asthma inhaler training device  developed by researchers at Cambridge Consultants.

Patients with asthma can use the inhaler and, via interactive software linked to the wireless device, get real-time visual feedback on the areas that need improving.

Specifically, whether patients have shaken the device before breathing in; whether they use sufficient force when breathing in; and whether they press down the canister that releases the drug at the optimal time. Click here to see a video of the T-haler in action.

Although still a conceptual product, the company says it has been designed as a training device to be available at pharmacies, schools, and clinics for children and adults alike.

They performed a study on 50 people aged 18 – 60 who had no prior experience with either asthma or inhalers and were given no instruction on how to use an inhaler. When tested, about 80% of the participants used an inhaler incorrectly.

They were then given the T-Haler with no further instruction and told to begin. A three-minute on-screen tutorial guided them through the proper use of an inhaler, and the success rate tripled to more than 60%.

“Without any human direction beyond the word ‘go’, participants went from around a 20% success rate without training to a success rate of more than 60% after only three minutes with the T-Haler device,” said Kate Farrell, a senior design engineer, in a news release. “This is more than twice the compliance rate we have seen in other studies with trained participants. Interestingly, a week later, 55 percent were still correctly using the device-showing that they retained what they learned.”

Whether the T-Haler itself will ever make it to market remains to be seen, but the concept of a 3-minute training device seems a no-brainer when it comes to properly using a device that may very well save the lives of the estimated 235 million asthma sufferers worldwide.

False and Misleading or Just Messy?

When it comes to marketing and promotion, most pharmaceutical companies play by the FDA rules. Violations result in Warning Letters. And Warning Letters are not good. Period.

To avoid such violations, drug companies have introduced promotional review committees and other measures to keep marketers on the straight and narrow.   Additionally, they’ve hired Compliance Officers, regulatory staff and legal counsel.  Now it seems, pharma may have to add house-keeping to the mix!

Last summer, NeurogesX, a San Francisco-based biopharmaceutical company exhibited at the American Academy of Nurse Practitioners meeting in Las Vegas to promote Qutenza  – a capcaisin treatment for neuropathic pain associated with postherpetic neuralgia; a condition that occurs as a result of nerve damage after an outbreak of shingles.

The NeurogesX exhibit included an eye-catching promotional panel for Qutenza featuring a polar bear. The panel made various effectiveness claims, and included all the risk and safety claims required by the FDA.  So, what’s the problem?

Well, according to a Warning Letter sent to the company the risk information was inaccessible to those who stopped or walked by because it was obscured by bags, boxes and other stuff! As a result, the FDA deemed the entire booth to be false or misleading.

How did the FDA know? Well, apparently three different personnel from the FDA Office of Prescription Drug Promotion, visited the booth separately at three different times, meaning this was not a one-off occurrence.

So, was this a simple case of carelessness or was NeurogesX trying to hide the risk information? I’m not sure we’ll ever know the truth, but it’s clear the FDA is “cleaning house” – one exhibit booth at a time.

Was the Agency justified?  If they really care about safety why didn’t they say something at the time, rather than let the boxes obscure the data throughout the show?  Let us know what you think.

A quarter of patients do not fill new prescriptions

As our regular Word on Health readers will know, I’ve had more than my fair share of trips to the pharmacy recently.  Painkillers, antibiotics, anti-inflammatories…the list goes on.  It’s not that I like taking tablets, I needed them.  Having taken time out of my busy life to see a doctor and get a prescription it would never occur to me to leave it languishing in the bottom of my purse.  However, according to a new study almost 1 in every 4 American’s does just that.

The study, published in the November issue of the American Journal of Medicine, evaluated more than 423,000 e-prescriptions written in 2008 for more than 280,000 patients. It was conducted by researchers at Harvard University, Brigham and Women’s Hospital, and CVS Caremark, who matched e-prescriptions with resulting claim data or those who did not claim prescriptions within 6 months.

What they found was that 24% of patients given a new prescription did not fill it. This percentage is higher than that seen in earlier studies.

“While some recent research has used e-prescribing data to evaluate primary non-adherence, we were able to study a nationwide sample of patients. Our finding that 24% of patients are not filling initial prescriptions reflects slightly higher primary non-adherence than seen in earlier studies,” said Michael Fischer, MD, MS, with Brigham and Women’s and Harvard Medical School, and lead author of the study.

Most prior research about medication adherence could not review prescriptions that were never filled by patients. However, the advent of electronic prescribing has provided an opportunity to track initial prescriptions that may have been previously undetected and gives healthcare providers a broader look at patients who never fill their prescriptions.

Researchers said the factors that are predictive of primary non-adherence include:

• the out-of-pocket cost of medications
• socioeconomic factors
• the integration of doctors’ health information systems
• the types of medications.

Prescriptions that are sent directly to mail-order systems and pharmacies are more likely to be filled than e-prescriptions that doctors print out and give to patients, according to the study. The researchers found that medications for hypertension and diabetes resulted in primary non-adherence rates in excess of 25%, while prescriptions for antibiotics and medication for infants were almost always filled.

SRxA works closely with a number of leading health outcomes experts and specializes in providing effective patient adherence programs.  Contact SRxA today to learn more.