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Selling Ranexa: A Prescription for Profiteering?

October 27, 2015
By

This is not an attempt to place blame nor to suggest that some of the physicians I allude to have done anything illegal. It is my review and inside story of how Pharma, sometimes using manipulation, get physicians to prescribe their drugs. For me it violates my mores, my intestinal beliefs, and for the readers, I hope, it helps explain a deeply entrenched pathology in the way drugs are prescribed, or more appropriately, “sold,” to doctors and patients in the United States.

Ranolazine, better known by its brand name Ranexa, is a drug approved for use in treating chronic stable angina (pain in the chest, often also spreading to the neck, shoulders, and arms), which is a symptom of coronary artery disease. The makers of the drug cannot claim it saves lives and must adhere to the FDA and published guidelines that state: “Ranolazine may be useful when prescribed as a substitute for beta blockers for relief of symptoms if initial treatment with beta blockers leads to unacceptable side effects, is less effective, or if initial treatment with beta blockers is contraindicated. May also be used in combination with beta blockers, for relief of symptoms when initial treatment with beta blockers is not successful.”

With effective, inexpensive medical therapy as well as the very high use of coronary stenting in the United States, Ranexa would appear to be a niche drug; a drug that might be used in the few patients who fail drugs like beta blockers, or in patients who remain symptomatic and whose angina is not fixable with coronary stent procedures.

The suggested first line of therapy, the beta blocker treatment (metoprolol, atenolol, to name a few), can cost as little as $40 for an entire year’s supply, while the cost of Ranexa, depending on dosage, is priced at about $300 to $500 dollars a month. That’s $40 a year for the suggested therapy and as much as $6,000 a year for the second-line treatment! It is also important to note that many of the studies that showed benefits for ranolazine used the highest and most costly dose of the drug.

The published data, in this case the largest trial assessing whether ranolazine might improve survival — the MERLIN-TIMI 36 trial — showed no benefit for the drug when compared to a placebo. To be fair, when studied in patients who had angina, ranolazine, especially at the higher doses, did show some modest improvement in the number of angina episodes. One study showed the number decreased from 4.3 episodes per week to 3.8 episodes per week .

In my busy urban cardiology practice I likely have fewer than five patients who have as many as four episodes of angina each week. For patients who have angina that limits their activity I can easily prescribe beta blockers or calcium blockers, or even long-acting nitrates, all which cost only a few dollars a month or… consider intervention with cardiac stenting. In America where just about every patient seems to go for a cardiac cath or stent, and likely too often as well, the need for ranolazine seems to be quite small. Ranexa, then, would likely be a drug prescribed mostly by heart specialists and in very small numbers.

When I reviewed my published prescription data I could not find Ranexa on my list and I suspect I prescribed the drug once or twice a year. When I looked for the top prescribers in New York, the state in which I practice, I found a physician who wrote over 700 prescriptions for Ranexa, just in the Medicare part D population (available at propublica.org), and who also, coincidentally, accepted speaking engagements and other remuneration from the maker of Ranexa, Gilead Pharmaceuticals.

I then decided to look at the Medicare part D prescription patterns of Ranexa and found New York State to be a veritable gold mine for Gilead Pharmaceuticals, with 18,678 prescriptions written for Ranexa compared to California’s 13,940. I next reviewed the top 25 prescribers for Ranexa in New York and then cross-reference these same physicians with the Sunshine Act data, available online, to see if any of them lectured for or received any remuneration from the manufacturer of Ranexa, Gilead. I also interviewed former Gilead reps as well as other Pharma and medical-device workers who were familiar with the physicians.

What I found is that most of the top prescribing physicians received lots of payments or dinners from Gilead. Some of the top lecturers weren’t even cardiologists and one was not even board certified in medicine. If Gilead is suggesting that their dinner talks are geared to educating physicians about the appropriate use of their drug, it’s a claim I regard as quite far-fetched. The most obvious expertise among these doctors, one might observe, was an expertise for arranging a quid pro quo, such as: you make me a paid speaker — I write prescriptions for your drug.

While some of the top prescribers practiced as cardiologists, I found a practicing hematologist , someone who claimed to be an expert in “legal medicine,” and others with barely any meaningful credentials.

Payments from Gilead to physicians ranged from a $10 lunch to expensive dinners valued at over $100 per person. But the really big bucks, (and to me clearly associated with an impetus for the physician to not just prescribe Ranexa, but to hype it), were paid for “promotional speaking,” with a single event, often given over dinner, sometimes garnering as much as $4,600 for the speaker.

In one case there appeared to be a circle of physicians specific to one ethnicity who were serviced by a pharmaceutical rep from their same ethnicity – a brilliant marketing idea for any industry: Find ways to make relationships and if that doesn’t work offer some form of legal remuneration.

My interview with reps who worked with other companies seemed to establish a similar culture and belief among many of these physicians with several reps telling me a similar story: Many of the physicians on this list often immediately asked pharmaceutical, device, or lab representatives, if they could be speakers for their company. And some of these salespeople I interviewed felt these very forward doctors clearly meant the question to be a surrogate for: “What’s in it for me if I prescribe your drug, or use your device or order blood from your lab?”

A few physicians on my list allegedly requested to be paid in cash if the salesperson wanted them to use their product. Quotes from current and former salespeople about Ranexa and the physicians I reviewed, included: “That guy’s known to be a bad dude” and “his patients are on every med in the book,” and when I asked about the cost of Ranexa: “If patients are OK with the co-pay, then why do you care about their finances?”

Gilead announced a 20% increase in sales of Ranexa in 2013 to about 450 million dollars in total sales, and appeared to approach a half-billion dollars in sales in 2014.

In 2012 alone drug companies spent about 24 billion dollars marketing directly to health care providers, with nine out of the ten largest pharmaceutical companies spending more for marketing than research.

Just as I completed this article, the results of a major trial using Ranexa, the RIVER-PCI trial, were released. It clearly showed that when compared to placebo Ranexa did not improve the outcome in patients with chronic angina who were left with some coronary blockages even after coronary stenting — the small class of patients I had earlier suggested might benefit from drug. One cardiologist in an online commentary wrote, “Kiss of death for his drug.” Not if they can sell it!

 

About the author: Evan S. Levine, MD FACC, is Director of the Cardiovascular Center at Saint Joseph’s Hospital and a Clinical Assistant Professor of Medicine at Montefiore Medical Center – Albert Einstein College of Medicine. He is also the author of the book “What Your Doctor Won’t (or can’t) Tell You”. He lives in Connecticut with his wife and children.

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5 Responses to Selling Ranexa: A Prescription for Profiteering?

  1. heartdude on December 31, 2015 at 8:10 pm

    We need a real outsider, someone who has never been influenced by or worked with big Pharma, to lead the FDA . Without that nothing will change.

    Dr Evan Levine

  2. liberalvoice on December 30, 2015 at 10:33 pm

    Agree @jamese. I’m wondering the same thing. Why can’t they protect consumers from abuses like this? I’d guess that the same party that has been staling and has tried to cripple the agency won’t let it happen. Thanks’ Republicans! You’ve scored another victory for the Big Pharma.

  3. Joseph Saks on December 12, 2015 at 2:47 am

    Who owns the FDA? Who owns America? It’s the wealthy and corporations, really.

  4. SteveH on December 8, 2015 at 2:49 am

    Ah, capitalism, isn’t it great? Profit over lives, stockholders over people.

  5. jamese on November 12, 2015 at 11:47 pm

    Why can’t the Consumer Protection agency look into the practices described in the article? Our expensive American medicine would be more affordable if there were some real oversight and laws with teeth in them.

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