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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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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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.