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.

Pumped Up about Promising new Parkinson’s Pump

Parkinson’s disease, as many of our readers know is a chronic, progressive neurological disease that causes sufferers to lose control of body movements, resulting in tremors, muscle stiffness, loss of balance and a host of other problems. Currently, there is no cure for Parkinson’s disease and treatment options are limited. Therapy is directed at treating the symptoms that are most bothersome and for this reason, there is no standard or “best” treatment for that applies to every patient.

Treatment approaches include medications and surgery (deep brain stimulation) as well as general lifestyle modifications (rest and exercise), physical, occupational and speech therapy.

Among the drug-related therapies, levodopa is considered one of the most effective for relieving the symptoms of Parkinson’s disease. It helps reduce tremor, stiffness, and slowness and helps improve muscle control, balance, and walking. Levodopa does not slow the disease process, but it improves muscle movement and delays severe disability. So far, levodopa, which had been used to treat Parkinson’s since the 1970’s, has only been available in pill form.

But a new Cleveland Clinic study finds that using a pump to administer a gel form of levodopa directly into the small intestine is much more effective.

Neurologist Hubert Fernandez, MD, who led the study, says, “The levodopa pump decreased or improved what we call the ‘bad time’ in Parkinson’s patients by up to four hours per day.” The levodopa can control this ‘bad time’ — the tremors, muscle spasms and other movement disorders that makes it difficult for Parkinson’s patients to function on a daily basis.

“This is an amazing finding,” says Fernandez. “We know of no other oral therapy that will improve the bad time in Parkinson’s by an average of four hours daily.”

The levodopa pump is external. It sits in a pouch under the patient’s shirt and provides a steady dose of the drug. The levodopa gel is administered directly into the small intestine, where most of the drug is absorbed. The constant dose makes the body’s movements more controlled and predictable, making it easier for people with the disease to plan and go about their day without worrying that the drug’s effects will wear off.

“The biggest advantage of the levodopa is its efficacy,” Dr. Fernandez says. “We’re trying to deliver it on a continuous basis so the patients don’t need to take it every hour.”

69-year-old Bob Van Housen has been living with Parkinson’s disease for over 12 years.  Prior to enrollment in the study he was having to take up to five levodopa pills every three hours to control his symptoms. Even then, his symptoms progressed to the point where it was hard to keep up.  “He was ‘off’ for at least seven hours,” said Van Housen’s wife, Carol. “Seven hours is a long time to not be able to function every day.”

The couple often had to cut their trips together short and limit their social outings outside of the house. Van Housen says that being part of the trial at Cleveland Clinic has been life-changing. “We can predict better how I’m going to feel and how I’m going to act and can plan trips and work around those times when I otherwise would have been problematic.”

The gel pump which is not yet available in the United States is currently under review by the Food and Drug Administration. Let’s hope it doesn’t hit any hurdles along the way, so others with Parkinson’s can avoid the roller-coaster of symptoms and enjoy the type of benefits that Bob has experienced.

Pharma Under Fire for Fair Balance Failings

Uh oh! Seems like the Pharma industry is in trouble again.

Research published in the Journal of General Internal Medicine suggests that family physicians receive “little or no information” about adverse effects associated with medicines in the majority of drug promotions made by sales representatives.

In the study, 255 family doctors from urban practices in the US [Sacrameto], France [Tolouse] and Canada [Montreal and Vancouver] answered questionnaires following visits from sales representatives.  The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

The findings showed that sales representatives did not provide any information about common or serious side effects, or identify the patients who should not be using the drug, in 59% of the promotions. In Canada, no potential side effects were mentioned for 66% of promoted products, according to the results.

The researchers also indicated that although 57% of the promoted drugs carried boxed warnings from the FDA or Health Canada, serious adverse events were only discussed in about 6% of the sales pitches.

Félicitations to the French reps who provided information on harm for 61% of the promotions, compared to only 34% in Canada and 39% in the US.

Despite this lack of “fair balance” overall, the doctors considered the quality of the scientific information to be good or excellent for 54% of the promotions and indicated that they would be willing to prescribe the drugs 64% of the time.

“Laws in all three countries require sales representatives to provide information on harm as well as benefits,” says lead author Barbara Mintzes, Assistant Professor at the University of British Colombia. “But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”

Despite widespread belief by physicians to the contrary, the information provided by pharmaceutical sales representatives has been shown to influence prescribing. Greater exposure to promotion is associated with higher prescribing volume and costs.  And while regulations in all three countries require sales representatives to provide information on the risks as well as the benefits of their drugs, there are differences.  It’s interesting, to correlate the above results with the fact that that France has the strictest information standards, whereas Canada relies on industry self-regulation.

However, across all three countries, the results of this study would appear to question if current approaches are adequate to protect patient health.

The Pharma Industry should take note.  Time to clean up your act before the Government and Regulatory Authorities do it for you.

Halloween Health Hazards

While fake blood and creepy costumes help make Halloween a howl, this October 31, beware of the hidden hazards that can turn the night downright dangerous. SRxA’s Word on Health shares these top tips from top docs, to keep you safe.

While there’s few things that says Halloween like a Jack-O’-Lantern, the American Academy of Pediatrics caution that pumpkin carving is no craft for children. Instead, they suggest that young kids limit themselves to drawing designs that adults can cut out. And rather than using candles to light your lantern, they suggest you consider glow sticks to get that long-lasting luminosity.

The American Academy of Ophthalmology, warns that if you want to see another Halloween you shouldn’t turn a blind eye to the increasingly popular crazy colored contact lenses on sale in party stores.  Although cat-like contacts may look cool, these over-the-counter lenses aren’t worth the risk. They can cause serious eye disorders and infections that could result in blindness.

And it’s not just contact lenses. Other parts of your Halloween costume can also be hazardous to your health. Over-sized costumes can quickly turn trick-or-treating into trip-and-tumbling.  And to avoid having to drop and roll, the  U.S. Food and Drug Administration recommends you only wear costumes made from flame-resistant fabrics.

Similarly, choose your mask carefully. Whether you chose “The Scream, Frankenstein, or Romney, make sure so you can see what’s coming. Some masks limit peripheral vision, so much so that you may end up being the thing that goes bump in the night.  But before you decide to skip the mask in favor of  makeup, don’t forget this has its own hazards too.  Sure, well-applied makeup can transform seven the most perfect skin into ghoulish festering  wounds, warts and scars, but it can also leave a rash that lingers into November. The FDA suggests testing the makeup on a small patch of skin a couple of days before using it on your face. And check out the agency’s list of approved makeup additives. If the makeup contains unapproved ingredients, toss it.

Finally don’t get tricked by your treats! The FDA recommends that children have their Halloween loot  inspected by an adult who can remove risky treats and anything that isn’t commercially wrapped. If you’re not sure what it is – get rid of it.

Whatever you do, please stay safe out there this Halloween.

Should new drugs wear a ‘Proceed with Caution’ label?

SRxA’s Word on Health was alarmed to read a new study showing that almost a quarter of prescription drugs approved in Canada over 16 years were later slapped with serious safety warnings or yanked from the market for safety reasons. As Canada’s drug safety agency operates much like the U.S. Food and Drug Administration (FDA), the study may reflect the state of drug safety in the United States as well.

When assessing a new drug, regulators at Health Canada and the FDA are entrusted with making critical and difficult scientific judgments that can affect the health of hundreds of thousands of patients in a matter of months after product launch.

And the cost of error may be high given that the number of people exposed to unsafe drugs may be in the millions.

University of Toronto health policy researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada’s drug-safety arm from the start of 1995 to the end of 2010.

About a quarter of the drugs approved in that period received a fast-track deliberation known as a “priority review” which lasts 180 days instead of the typical 300 days.

Lexchin found that drugs approved this way were 50% more likely to end up with safety warnings, compared with drugs approved according to the customary deliberation period.

And while you might assume that the most-risky drugs would be those those fast-tracked for approval for life-threatening diseases such as cancer and HIV, Lexchin discovered they were no more likely to have safety concerns than drugs fast-tracked for less serious illnesses.

That was a surprise, because regulators could be expected to accept some heightened risks when approving new medications to treat serious illness.

In an accompanying editorial, Thomas J. Moore of the Institute for Safe Medication Practices suggests that new drugs should carry special labeling for their first three years on the market, so that doctors are reminded to prescribe with caution.

“Getting faster access to newer, less-thoroughly tested drugs is at best a mixed blessing,” said Moore. “For the first three years after approval, new drugs should carry a special warning akin to the black triangle used in Britain. It should be prominent and mean to every physician, ‘New Drug: Caution Indicated.’ ”

That caution may be worth remembering by both physicians and patients when considering switching to new drugs.

Prescriptions, Physicians, Patients and Payers: Let the battle commence!

Last week the FDA announced that it wants to remove obstacles to America’s most commonly used drug treatments.  If the Agency gets its way, some drugs used to control chronic conditions, such as high cholesterol, diabetes and asthma may soon be available without prescription.  But in doing so, they have reopened a  big can of worms. One that brings into question the very nature of health reforms, preventative medicine and improved access to healthcare.

Here’s the proposal: The FDA would create a new class of “safe use” drugs. While consumers would not need a prescription, they would still need to get clearance from a pharmacist or from specially designed websites to purchase them.

Battle lines are being drawn! With physicians on one side, and patients, pharmacists, pharma and payers on the other.

Doctors are most definitely not thrilled by the idea. Removing the prescription requirement for an inhaler refill, for example, doctors fear they would be taken out of the loop on everyday care decisions.

Insurers, on the other hand are embracing the move. They recognize that they could save big bucks if physician visits weren’t required for run-of-the-mill complaints and ongoing medication monitoring. They might even save on the costs of the drugs themselves because, depending upon how they’re classified, most health plans don’t pay for over-the-counter treatments.

Pharmacists see it as validation of their expertise and pivotal role in primary healthcare and the pharmaceutical industry, who has repeatedly asked for permission to sell such drugs over-the-counter, must surely be cautiously optimistic.

Even normally conservative regulators are supporting the move. “Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers,” former FDA commissioner Scott Gottlieb said via Twitter. “It’s a good idea, long overdue.”

Even so, the FDA will have a fight on its hands as it moves to turn its proposal into reality. The American Medical Association lambasted the idea in USA Today, saying that patients need guidance from doctors. The doctors’ association also points out that giving patients more control could complicate coordinating care, such as, tracking all the drugs a patient uses to prevent interactions.

But, as The Washington Post points out, FDA sees the doctor’s visit as a hindrance to care; some patients don’t seek treatment if they have to see a physician first. “Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” says Nancy Chockley, president of the National Institute for Health Care Management.

About 20% of prescriptions written in the United States currently go unfilled. Removing obstacles that keep Americans from managing their own health care is, according to one patient, namely me, a good thing.

The FDA contends, and I agree, that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner.  Earlier this month, I stood in line at my local pharmacy for thirty minutes to pick up a refill prescription for blood pressure meds. On reaching the end of the line I was told that there was no prescription. The pharmacist called my doctor and the lack of prescription was confirmed. I called my doctor and was told I would need to make an appointment to have the prescription renewed. I pointed out that I had done that one month earlier and that nothing had changed regarding my health. I was then informed that it was a new policy to issue prescriptions on a month-by-month basis rather than provide automatic refills. Even when I pointed out that I have a chronic condition that I’m doing my best to manage and part of that management is the medicine I have been taking for years, they wouldn’t sway. No doctors visit, no prescription.  And the kicker, I couldn’t get an appointment to see my doctor for a week…meaning, I had to go 7 days without blood pressure meds, all so my doctor could better manage my care!

Practicing medication adherence is very hard when your doctor won’t give you medication…and leaves me wondering if this policy change had more to do with revenue generation than improving chronic disease management.

My personal experience aside, at the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician as a hindrance to care, whereas doctors see that visit as crucial, especially as chronic conditions become increasingly prevalent.

The FDA proposal is still in formative stages, meaning there’s still a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding health policy on what role doctors play in managing patient care – and, at what point, the patient takes charge.

I, for one, can’t wait to see how it plays out, assuming of course that I’m not dead from uncontrolled hypertension!

Do DIY “spit kits” stress you out?

One of the fastest growing health care trends in “individualized medicine” is home genetic testing. The over-the-counter mail-in kits, with price tags as high as $2,500, use a saliva specimen to identify small variations in the human genome  associated with heightened risk for diseases such as diabetes and prostate cancer.

The U.S. Food and Drug Administration (FDA) has raised concerns about whether the tests are clinically beneficial and has advocated they be conducted under medical supervision, but few studies, to date, have investigated the emotional effects that direct-to-consumer genetic screens have on patients.

Now that’s all changed.  A group of Mayo Clinic physicians and bioethicists have analyzed whether these genetic tests cause patients to experience excessive worry about developing diseases. “We looked for evidence of increased concern about disease based solely on genetic risk, and then whether the concern resulted in changes in health habits,” said co-author Clayton Cowl, M.D.

The randomized study found patients’ worry tended to be modestly elevated one week after the genetic testing, and that people worried more about unfamiliar diseases, for instance the thyroid condition Graves’ disease than those commonly known, such as diabetes.

One year later, however, patients who had undergone testing were no more stressed than those who hadn’t. One surprising result was that men whose genetic risk for prostate cancer was found to be lower than that of the general population, and who also had normal laboratory and physical screening results for the disease, were significantly less stressed about the disease than the control group.

The researchers concluded that the tests may be useful if they prompt patients to make health-conscious changes, such as losing weight or being vigilant about cancer screening.

However, some doctors are concerned that patients who learn they have less-than-average genetic risk for a disease might skip steps to promote good health. Others just think it’s a bad idea – period.  “Genetic testing is a complex, difficult and emotionally laden medical process which requires extensive counseling, contextualization and interpretation,” says Dr. Michael Grodin, professor of bioethics, human rights, family medicine and psychiatry at Boston University.

It’s also worth noting that the current study only assessed the emotional effects of do-it-yourself genetic testing. Nobody yet knows whether a calculation of genetic risk accurately predicts disease.

Have you bought one of these kits?  How did you feel while you waited for the results. SRxA’s Word on Health would love to know.

Big Brother may not be watching, but the FDA, it seems is!

Here at SRxA, we all know how much physicians like to put on their marketing hats. In future, it seems, they might have to reach for their safety helmets instead!

According to our fellow bloggers at Good Promotional Practices doctors are starting to be held accountable to the same promotional compliance standards as pharmaceutical companies.

As most of our readers know, when FDA approves a drug it does so for a given use or indication. However, physicians are still free to make their own decisions based on how a device is used based on their best judgment. When a drug, biologic, or medical device is used for some indication other than the one approved by the FDA it is said to be “off-label.”

In this almost perfect dichotomy, it is perfectly legal, in the United States, for a physician to use a drug or device for “off-label” but it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Furthermore, based on the flurry of DOJ, OIG and FDA activity, such as the massive fines leveled out to Allergan ($600M), GlaxoSmithKline ($750 M), Novartis ($422 M) and Pfizer (2.3 billion) companies must keep the practices of their marketing and sales department in check to ensure compliance.

Until now the “it is unlawful to market, advertise or otherwise promote off label use of a drug” has been aimed at Pharmaceutical companies and third parties acting on their behalf.  Now people are asking “What if the hospital or physician group is doing the marketing themselves, not the company?”

We’ve all seen the billboards and free in-flight magazine ads promoting the latest medical treatments from liposuction to joint and hormone replacement.  With physicians are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Blogger Sean McCarthy uses the example of the irregular heart rhythm Atrial Fibrillation (AF, AFib).  While there are very few approved drugs or devices to treat atrial fibrillation, upwards of 2.5 million Americans suffer from this debilitating condition.  Not so surprising then, that physicians use an array of off-label drugs and devices to treat this disease. So, now the hospital or physician communicates their ability to help AFib patients by promoting their latest treatment for the disease on a billboard or newspaper article. Isn’t this the same thing as a company promoting off-label use?

State Attorney Generals, the DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.  McCarthy says he’s heard rumors of a state Attorney General investigating a doctor about his referral patterns and advertising activities.

Who better than the pharmaceutical industry to take the lead in providing education to physicians  to help them prevent compliance snafus.  After all we’ve been there, done this!

Contact SRxA today to see how we can get you started.

FDA Warning – Time to get personal

In a move guaranteed to send shock waves around the industry, FDA lawyers just announced that CEOs of pharmaceutical companies could face prosecution for off-label drug marketing.

The FDA’s Deputy Chief of Litigation, Eric Blumberg, said, “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion. It’s clear we’re not getting the job done with large, monetary settlements.”

Although the lawyer didn’t specify when the agency will start to implement sanctions, he warned company executives not to wait until the first charges are brought.

“If you’re a corporate executive or are advising a corporate executive, now is the time to comply,” continued Blumberg.

Non-compliance with the order could result in executives incurring fines of up to $100,000 and up to one year in jail. In addition, regulators could also bar individuals from working in the drug industry.

Prosecuting executives for violations of the federal Food, Drug and Cosmetic Act falls under the Park Doctrine, a long forgotten, and rarely used statute named after the 1975 U.S. Supreme Court case against a retail food chain president.   In essence, the Park Doctrine allows prosecutors to hold CEOs responsible for the crimes of their underlings, even if they had no specific knowledge of their actions, on the general principle that CEOs have a responsibility to ensure that their organizations follow the law.

For small companies with rigorous compliance in place this should not be a problem, but for the giant pharma entities with upwards of 100,000 employees is it realistic, let alone possible, for the CEO to make sure they’re all obeying the law?

If you’re a CEO of a pharma company, or an employee who would like to stay employed, then look no further than SRxA.  We are here to help you through the complexities or compliance and create worry-free marketing and educational initiatives, guaranteed to help you and your boss sleep at night.

Contact us today for further information.

Fake drugs hurt patients and pharma

Your Word on Health bloggers suspect that there’s probably not a single one of our readers who hasn’t, at one time or another, received a spam e-mail promising erectile dysfunction drugs at bargain prices.  While annoying, we can get rid of these with fast and judicious use of the delete button.Counterfeit drugs, made in Asia and other emerging markets, are however a more serious and growing problem.  According to the Pharmaceutical Security Institute (PSI), last year, almost 1,700 incidents of counterfeit drugs were reported worldwide –  triple the number in 2004.Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year.  The World Health Organization suspects that more than 50% of the medicine bought from certain illegal websites are fake. As frightening as that figure is, the market is probably much bigger because many cases are hard to detect…and the problem is expected to get worse. Fake drugs are a “money machine.” Sales are growing at twice the rate of legitimate pharmaceuticals, says Peter Pitts, president of the Center for Medicine in the Public Interest.  A weak economy along with rising drug prices are likely leading consumers to seek out cheaper products online or from unauthorized providers. However, others believe that it’s not cheaper prices that drive consumers to counterfeit medicine, but their “lack of education and awareness of the dangers.” Counterfeit medicine may include too much, too little or none of the ingredients found in the real product, causing injury and, in extreme cases, death. While fake drugs have been around for decades, the Internet’s growth and the popularity of Pfizer’s erectile dysfunction drug Viagra in the 1990s created the “perfect storm” to fuel this underground industry. Today, drug rings in Asia, particularly in China and India, are increasingly churning out fake versions of popular brands and generics, then selling them to consumers online or in the black market. Counterfeiters are now able to fake drugs so well, even experts find it hard to distinguish the copies from the real deal. And they’re able to replicate security devices such as holograms only a few months after pharmaceutical companies put these features on their packages. “You can make more money in counterfeit drugs than heroin,” says Tom Kubic, CEO of PSI. “There’s a major financial incentive for criminals because of the low risk of detection and prosecution.” Now, drugmakers are fighting back.  Most pharmaceutical companies routinely gather information about fake drugs and pass it along to authorities. Some are even sharing such information with their competitors, sometimes leading to raids of suspected manufacturing facilities. Fake medicines put both the reputation of the industry and, even more importantly, patients’ lives at risk.  They also divert consumers away from the legitimate products. The FDA has produced some great resources to educate people about dangers of fake drugs. Along with tips for buying medicines, the Agency’s website offers summaries of recent safety alerts and how to spot and report fraudulent or dangerous products. One example of this is their “Warning Signs” of an unsafe drug web site. They advise consumers to stay away from any site that: offers prices that are dramatically lower than the competition may offer to sell prescription drugs without a prescription—this is against the law sends you drugs with unknown quality or origin gives you the wrong drug or another dangerous product for your illness doesn’t provide a way to contact the web site by phone

Seems the old adage “you get what you pay for” applies to drugs too