Death of the Pharma Sales Rep?

bah humbugWe’re not feeling a whole load of Christmas cheer among the pharmaceutical industry this festive season.

First came the news that GSK is phasing out all payments to doctors and will no longer be bonusing their reps based on sales.  Now, a new study suggests the end of the road may be nigh for pharma sales reps.

According to a survey of nearly 3,000 physicians undertaken by CapGemini and QuantiaMD, when it comes to receiving clinical and medical info, reps rank last as a resource behind print, digital media and phone links.

  • 67% of physicians say digital media is their preferred source of information from drug-makers
  • 40%  believe digital media has the most relevant and personalized content
  • 52% believe sales reps will eventually become information coordinators
  • Only a paltry 20% say reps are their favorite source of information

no repsIn parallel, more health care providers are shifting toward larger, organized health systems, which make it more difficult for reps to reach physicians for visits. Sixty four  percent of those surveyed say they restrict rep visits and 31 % of physicians in organized health systems do not allow reps any access, due to corporate policies.

Newer and younger physicians are more likely to rebuff reps – as many as 80%  impose restrictions. 90% of new physicians are joining organized health systems right out of medical school.

Physicians today are in a time crunch, juggling more commitments than ever before and no longer have the time to dedicate to in-person meetings with pharmaceutical representatives. So the reliance on more digital channels comes as no surprise,” said Dan Malloy, Senior Vice President at Quantia. “This study supports what we’re already seeing from our 200,000 members–that a physician-centric, digital communication model is the most effective way for reaching and engaging doctors.”

On a more positive note, reps slightly edge out other resources when it comes to finding product info and patient education.

Hala Qanadilo, a principal in life sciences at CapGemini says, “While the more traditional face-to-face, in-office visits might decrease, the role of these representatives is projected to be as important as ever. Moving forward, they will need them to be the directors of multiple information sources, customizing their outreach so it is more personalized and physician-centric.”

How are you tackling the changing healthcare environment in these increasingly restrictive times?  We’d love to hear from anyone out there in Pharmaland.

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Compounding the Problem?

healthcare crisisHere’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

fungal meningitisWhile there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

fungal meningitis case-counts-960px-2013-10-23Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

compoundingThe bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

NECC steroidsSimilarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

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FDA ups the Ante on Pharma Ads

bad ad cme courseAs 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.

bad ad course screen shotThe 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:

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.

Bad Ad brochure 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.

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Pharma Under Fire for Fair Balance Failings

Unfair balanceUh 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.

yes no riskThe 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.

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A Ray of Sunshine?

sunshineIt’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 1st, 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.

doctor_bribes_0318And 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

doctor + moneyAdvocates 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.

physicians_relationship_with_pharma_companThe 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.

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Rehab for Ruined Reputations?

pharma industryAfter 25+ years working in or for the pharmaceutical industry, I’m probably one of its greatest supporters. I’ve witnessed the impact that pharma R&D has on the lives of patients, the benefits that pharma supported education offers physicians and the global impact of the pharma industry on the economy.

Yet despite all the good it does, pharma has somehow ended up with a reputation that, to put it mildly, sucks. Rather than being hailed as responsible and innovative the public perception of the industry is more likely to be fat cat greed.

So how did pharma earn itself a place in the ‘damaged goods’ file?

According to a new survey pharma’s poor reputation  stems mainly from concerns over safety, pricing and transparency.

The global survey, conducted by Patient View, in November and December 2012, explored the views of 600 international, national, and regional patient groups on the corporate reputation of the pharma industry as a whole, and the top 29 companies in particular.

The results are in and they’re not good. The Pharma Industry’s reputation has taken a dive.

ReputationOnly 34% of those surveyed said that multinational drugmakers had an ‘excellent’ or ‘good’ reputation last year- compared with 42% in the 2011 survey.

The survey also asked patient groups – many of which receive financial backing from the pharmaceutical industry – to rank drugmakers on six indicators that influence corporate reputation: patient-centeredness; patient information; patient safety; useful products; transparency; and integrity.

Overall when comparing 2012 with 2011, the industry’s reputation suffered the most in the following areas:

  • managing bad news about drugs (29% decrease)
  • having ethical marketing practices (23% decrease)
  • having a good relationship with the media (19% decrease)

Other factors cited for the poor performance: a continuing failure to help patients in cash-strapped countries gain access to medicines; a preoccupation with drugs that offer short-term health benefits and not enough effort made to discover new drugs for neglected groups of patients.

Patient groups also pointed to inappropriate and off-label marketing; a perceived lack of transparency, especially when it comes to reporting disappointing trial results; and giving the impression that profits come before patient well being.

What else?

pharma money13% said that the industry does not provide high quality patient information; 11% believe that no drugmaker has a good patient safety while 9% think that the industry does not provide useful products.

Brand-name drugmakers, ranked poorly compared with other players in the healthcare sector. Patient groups graded retail pharmacists, medical device makers, generics companies and even “for-profit” health insurers, as having ‘excellent’ or ‘good’ reputations. Only non-profit health insurers fared worse.

Can the industry turn itself around? We sure hope so.

Stakeholders, especially those who receive money from the industry, should respect pharmaceutical companies as corporate citizens.  At the same time, Pharma needs to recognize that they have a  key opportunity to demonstrate leadership by addressing the growing problem of chronic disease. Policy-makers, health care providers and patients will all benefit if the industry plays a more prominent role in helping to better manage chronic disease and partner with the public health community in promoting disease prevention.

And Pharma needs to tackle the price complaints head on, rather than shying away.  Whatever happens with healthcare reforms, politics or the economy, affordability and pricing will remain perennial reputational challenges for the industry. Period. We are all consumers at heart. Consumers, looking for bargains. And while I don’t support price cuts, I would advocate greater transparency around drug pricing. Pharma could both help themselves and make a meaningful impact by educating policy-makers and the public on the cost of medicines and by demonstrating how medicines decrease health care costs overall.

Managing reputation by meeting stakeholders’ myriad expectations for pharmaceutical companies is more than merely ‘doing the right thing.’

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The Growing Cost of Aging

With the election looming, we’ve heard a lot of rhetoric about healthcare. Rising costs, limited access, reforming Medicare…the list goes on and on.  Whatever happens on November 6, it seems the American public has already spoken. According to new research just unveiled at the American Public Health Association’s Annual Meeting, the cost of lifestyle drugs now exceeds the cost for medications used to treat chronic disease.

The research suggests that medicines used to treat conditions considered a normal part of aging, including those related to hormone replacement therapy, sexual dysfunction, menopause, aging skin, hair loss and mental alertness, are becoming so popular that they now rank third.  Only diabetes and high cholesterol have a greater cost impact among commercially insured patients.

Researchers at Express Scripts in St. Louis looked at trends in prescriptions filled for aging medications.  In 2011 alone, the cost per person for aging medications ($73.30) was 16% greater than the amount spent on both high blood pressure and heart disease medications ($62.80).  The cost for diabetes medications was $81.12 and high cholesterol medications was $78.38.

The research found that among these insured individuals use of drugs to treat the physical impact associated with normal aging was up 18.5% and costs increased nearly 46% from 2006 to 2011. Increased use of these drugs was even more pronounced for the Medicare population (age 65+), up 32% from 2007 to 2011. The largest utilization jump among Medicare beneficiaries was from 2010 to 2011, up more than 13% and outpacing increases in the use of drugs for diabetes, high cholesterol and high blood pressure combined.

At a time when people are forgoing care due to rising health costs, this study reveals a growing trend on where the public is placing its healthcare dollars,” said Reethi Iyengar, PhD, researcher at Express Scripts.  “Continued monitoring and potential management may be warranted for this category of medications.”

While there is no doubt that pharmaceutical advances and greater awareness have improved the quality of life for many aging Americans what was not known, until now, is the significant cost associated with treating these conditions. Couple that with the proliferation of people living longer and it’s clear that managing the trend and spend from treating conditions associated with aging will become increasingly important.

The United States is in the midst of a profound demographic change, with the number of elderly people projected to reach nearly 20% of the entire population by 2030, up from less than 13% in 2009. This increase will continue to drive both use and costs of medications to treat the natural conditions of aging.

But the problem may be even bigger. The greatest growth in cost per insured was seen among the 45 to 54 age group – up almost 21% over the last five-years. And because the study only analyzed prescription medications it may have underestimated the total costs of aging treatments, which include a variety of over-the-counter medications, cosmetic treatments and surgery.

Seems getting old hurts not only our bodies, but our wallets and the economy too.