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.

To Give or Not to Give? – That is the question!

Few people in the respiratory community will have missed the study published last week in the New England Journal of Medicine (NEJM) that demonstrated Spiriva is comparable to Serevent in adults with uncontrolled asthma.

For those of you who did, SRxA’s Word on Health is pleased to provide you with a quick recap:

210 people with uncontrolled asthma were enrolled in a three-way, double-blind, triple dummy study.

All patients were treated with a beclamethasone inhaler (Qvar) to which was added Spiriva (tiotropium bromide), Serevent (salmeterol xinafoate) or a double dose of Qvar.

Results showed that Boehringer Ingelheim’s Spiriva, which is not currently FDA approved for asthma,  worked better than doubling the dosage of Teva’s Qvar and was just as effective as GlaxoSmithKline’s Serevent.

Interesting stuff, but in our opinion that was not the real news!

In an accompanying editorial, editors of the NEJM, chastised GSK for failing to provide free study drug to investigators from the National Heart, Lung, and Blood Institute. Apparently manufacturers were approached to supply both active drug and placebo inhalers, and while Boehringer Ingelheim (the manufacturer of tiotropium) and Teva (the manufacturer of Qvar) agreed to provide the materials, GlaxoSmithKline (the manufacturer of Salmeterol) refused.

The net result of this, say the editors was that investigators had to spend $900,000 from the National Institutes of Health (NIH) – and therefore they say, from taxpayers – to repackage the active drug and to create a visually identical placebo for use in the trial.

In a passionate conclusion to the editorial, Curfman, Morrissey and Drazen say:

“The most precious commodity that drug manufacturers possess is the trust of their research subjects, and to maintain this trust they need to be willing to put their products at risk. When they refuse to provide their drugs to legitimate investigators, the researchers will get their studies done without company help. It will take more time and cost more money, but in the end, the research will be done and the company will be perceived as having acted in its own self-interest rather than having worked to enhance the health of the community.”

This story was picked up by various news media who continued the vilification of GSK.

Here at Word on Health we’re not so sure that this criticism is justified.

First, pharmaceutical companies are not required to donate products for third party studies.

Second, Serevent is already licensed for the treatment of asthma. The company has previously performed numerous trials to demonstrate its efficacy and safety, including four studies on its effects in patients with asthma on concomitant inhaled corticosteroids.  In other words GSK did not need this study.

Boehringer, on the other hand did.

Two years ago, safety concerns were raised with Spiriva inhalers. Although the FDA has since said that recent data do not show a connection between the inhaler and previously reported risks of stroke, heart attack and death, doubts continued to linger in the market.  Additionally, as Spririva is not yet approved for use in asthma, any data that could show efficacy in this indication would potentially be an important step in gaining an additional licensed indication.

It is also worth noting that the total cost of the study was > $5.3 million. Tax payers money was being spent regardless.

And finally, it’s not as if Glaxo don’t pay their dues.  They are a member of the Partnership for Quality Medical Donations (PQMD), an alliance of pharmaceutical companies and humanitarian agencies that works to encourage the donation and timely delivery of appropriate medicines to people in need. They were one of the biggest donors of drugs and emergency medical relief following the monsoon floods that hit Pakistan in August; they have provided in excess of $1 million dollars of drugs to Haiti since the earthquake, more than $2 million to South East Asia. They also helped out following floods in El Salvador, wild fires in California, cyclones in Myanmar and the 2009 earthquake in China.

Should companies be forced to donate product to studies that are of no interest to themselves, or should they be free to spend the money and donate their product where they wish?

Should highly respected medical journals be allowed to single out companies for exercising their right to chose how they allocate their product?

Word on Health would love to know what you think.

In the interests of full disclosure we’d like to point out that none of the companies mentioned in this story are current clients of SRxA.