In 2013, the FDA finally approved a drug without estrogen for the treatment of menopausal symptoms. When compared to placebo, a study shows that Brisdelle significantly diminished the number of hot flashes in women who took the drug for at least four weeks and for as long as three months. To many it appears to be an amazing new treatment — something hitherto unavailable that may indeed improve the lives of menopausal women.
For me, it’s yet another example of Big Pharma exploiting an unwary public with the phrase “Approved by the Food and Drug Administration.” Brisdelle is the trade name of a drug that has been available for years as a cheap generic, paroxetine, also known as Paxil, now rebranded and sold in a dose that is both convenient for the manufacturer and equally inconvenient for the consumer.
In a brilliant stroke of duplicity, Noven Therapeutics conducted its trial using a 7.5 mg dose of the drug — knowing full well that the comparable generics are only approved in a 10 mg and 20 mg pill. Had they performed their studies using a 10 mg dose, or even a 5 mg dose, consumers could have just sidestepped the Brisdelle formulation and asked for a prescription of generic 10 mg tables — cut in half for the smaller dose. But now, if they wish to take the study dose, they’ll either have to buy the Noven product or estimate what three-quarters of a 10 mg pill is.
The real miracle here is that Noven has made more out of less. With the retail price of Brisdelle at nearly $6 for each pill, compared to a 12-cent price for each 10 mg pill of paroxetine (when purchased at a three months’ supply), the profits for Noven must make companies like Halliburton quite jealous. If you do the math you can purchase about a year’s supply of generic paroxetine for about the cost of a week’s supply of Noven’s branded paroxetine.
Noven likely needed to separate its $6 paroxetine further from the generic 12-cent paroxetine, so … clever devils that they are, they used a well known but very legal maneuver to do so and created a drug that the FDA would consider an alternative rather than an equivalent drug to generic paroxetine.
Drugs that are equivalent, according to our FDA, can be substituted for each other, as a generic is for a brand name, since they are essentially identical. But Noven and its artful team decided to change the salt paroxetine is bound to. Instead of paroxetine–HCL (paroxetine-hydrochloride), the original formulation of the available cheap generic, they combined it with a different compound, mesylate, producing paroxetine-mesylate. And to confuse matters more, and distance their drug even further from being considered an equivalent drug, they manufacture Brisdelle as a capsule instead of a pill, another reason for the FDA to consider Noven’s paroxetine just enough different for it not to be considered equivalent to the generic.
While physicians, the Food and Drug Administration, and even Noven Therapeutics clearly recognize that these “drug products” contain the identical therapeutic moiety (the actual drug molecule — since the compound it’s bound to, either HCL or mesylate, is inert), the FDA does not consider the drugs to be equivalent and thus will not allow a physician or pharmacist to substitute generic paroxetine for Noven’s paroxetine. If someone were to ask Noven to honestly explain why they made this alternative drug in capsule form instead of a pill, attached to a different compound, and in a slightly altered dose, they might answer, “Because that’s where the money is!”
To be fair to Noven Therapeutics, they did perform a standard double-blind randomized trial matching their drug, Brisdelle, to placebo and they did find that when compared to a placebo effect, their pill, as their statement says, “is proven to reduce moderate to severe hot flashes during menopause.” But I want you to focus on the word reduce as I continue to deconstruct Noven’s devious stratagem.
In this trial, funded by Noven Therapeutics, at four weeks patients who received Brisdelle had an average of 4.3 fewer hot flashes in a day. Those who received the placebo had 3.1 fewer hot flashes a day. A statistically significant number, but in the end just one fewer hot flash, when you take a medication better known to treat depression, one that, according to the FDA, may “increase suicidal thoughts or actions within the first few months of treatment.”
At 12 weeks into treatment, those patients who took this antidepressant had, on average, 5.9 fewer hot flashes and those patients who took the placebo had 5.0 fewer hot flashes; again statistically fewer hot flashes for those who took the Brisdelle, but not even less than one fewer hot flashes a day when compared to the nothing-pill. A quick review of the data and you’ll notice that the subjects taking the placebo for three months actually had fewer hot flashes than the patients who took it for a month!
And now the most disturbing part. The FDA’s independent advisory committee voted 10-4 not to approve Brisdelle, in March of 2013, on the grounds that it did not provide sufficient benefits. Yet the FDA went ahead and approved it anyway! The FDA rarely approves a drug that has more negative than affirmative votes.
So what is Brisdelle? Another example of Big Pharma gaming the system — taking a very cheap generic and transforming it into an expensive, high-profit drug that has a marginal effect on quality of life compared to placebo and could easily be replaced by a cheap generic. And thanks to direct-to-consumer advertising in the United States (only two countries in the world allow it), they can advertise their product to millions of women via radio, TV and magazine ads, who will subsequently ask their doctors for a prescription, unaware that they are being exploited yet again by Big Pharma.
In an upcoming article I will address how I have treated and helped women with perimenopause reduce or completely eradicate their symptoms, and for only a few pennies a day.
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 and editor of the Journal of Medicine. He lives in Connecticut with his wife and children