Acadia Pharmaceuticals: This Is Not a Pharmaceutical Company

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Illustration: Edel Rodriguez

Illustration: Edel Rodriguez

Frequently sporting a $2 billion plus market capitalization, Acadia Pharmaceuticals brings to mind the work of Belgian surrealist Rene Magritte. His 1929 painting “The Treachery of Images” depicts a pipe with the inscription “This is not a pipe,” suggesting that an image and its meaning don’t necessarily correspond with each other.

In that vein, San Diego–based Acadia portrays itself as a pharmaceutical company but a Southern Investigative Reporting Foundation investigation has revealed that this is merely a clever facade. What lies below is a ruthless marketing entity whose pursuit of regulatory approval is best described as “loophole-centric.”

Nonetheless, in little more than two years, Acadia has gained a remarkable foothold in the pharmaceutical marketplace. The company generated Sources: LinkedIn and the Southern Investigative Reporting Foundation Sources: LinkedIn and the Southern Investigative Reporting Foundation[/caption]

 

If the name Avanir rings a bell, it may be because Source: Company documents Source: Company documents[/caption]

 

Dig into Avanir’s quarterly filings, however, and Nuedexta’s waning prospects appear in sharper relief. In the second quarter of 2017, sales of the drug totaled nearly $64.5 million. But in the first quarter of this year, its sales declined to $49.8 million.

A Centers for Medicare and Medicaid Services Sources: SEC filings and company documents Sources: SEC filings and company documents[/caption]

 

Unlike Avanir, Acadia does not have a deep-pocketed parent to absorb the potentially steep costs should regulators and plaintiff’s lawyers begin to demand answers.

One area where Acadia has hewed closely to Avanir’s script can be found in the Centers for Medicare and Medicaid Services Source: The Centers for Medicare and Medicaid Services' Open Payments database  Source: The Centers for Medicare and Medicaid Services’ Open Payments database[/caption]

 

Over the six months that Nuplazid was commercially available in 2016, Acadia Source: The FDA's adverse events reporting system Source: The FDA’s adverse events reporting system[/caption]

                                 
Reports uploaded to the FAERS database that indicate a patient died while taking Nuplazid sharply outnumbered the reported deaths of those on the nine other drugs: A total of 610 individuals died while taking Nuplazid but just 87 died while taking any of the nine other medications. Nuplazid-tied deaths represented more than 38 percent of the total number of serious incidents; but for those taking any of the other nine medications, death amounted to less than 5 percent all serious incidents.

These results cannot be interpreted as definitive: Patients taking Nuplazid are usually quite frail since they have had Parkinson’s disease for several years and might be weaker on average than the people on the nine other drugs. Additionally, newer drugs tend to draw more FAERS submissions than more established ones.

But these results certainly show Nuplazid has a radically different safety profile than other Parkinson’s disease treatments.

A second chart explores whether Nuplazid’s seemingly high level of adverse event reports is similar to reactions to another central nervous system-targeted drug, Sources: The FDA's adverse events reporting system and the Southern Investigative Reporting Foundation Sources: The FDA’s adverse events reporting system and the Southern Investigative Reporting Foundation[/caption]

                       
Calculating the number of deaths as a percentage of the number of adverse events associated with the rate for Namzaric is tricky because few people who took either drug did so for the same amount of time.

Fortunately medical statisticians can rely on a measurement tool called “patient years.” It is an average of how many patients have taken a specific drug over the course of a given year. For example, assume a certain drug costs each patient $10,000 a year to take and that the medication had $100,000,000 in sales. Using the patient years calculation, researchers could say that roughly 10,000 patients took the drug for one year.

For this chart each drug’s annual sales figure was divided by its retail price at the end of 2016 and 2017: Namzaric cost $4,249 at the end of 2016 — and $5,069 in 2017. For Nuplazid, it was $25,000 and $33,336, respectively. Namzaric’s patient years figures in 2016 and 2017 were 13,536 and 25,805; Nuplazid’s were 692 and 3,747.

“Deaths per patient year” is a rough statistical way of measuring patient deaths while assuming the typical patient used the drug for a full year. Epidemiologists call this “the excess death rate,” or the number of deaths above what is reasonably anticipated in a population group.

The number of patient deaths for Namzaric was a scant .0001; Nuplazid’s tally, however, was .0881 in 2016 and .1033 in 2017.

So in 2016, if 1,000 patients took Nuplazid for one year, about 88, or 8.8 percent, could be expected to die over and above the already steep mortality rate of approximately 25 percent; in 2017 the figure would rise to 103. But it would take 10,000 patients on a Namzaric protocol for a full year for a single death to result.

This is the full text of Acadia’s response to the Southern Investigative Reporting Foundation’s questions.

Editor’s note: To obtain the fairest profile of the drug histories, the Southern Investigative reporting Foundation used adverse event reports of “serious cases,” or incidents that required medical attention, and then deaths were subtracted from this total. For the death figures, only deaths reported as a prospective reaction to a drug were counted, as opposed to the higher “death cases” figure that the FDA records.

Correction: An earlier version of this story inaccurately described Nuedexta’s safety profile. It has never carried a black box warning. Also Avanir Pharmaceuticals has two drugs that are commercially available.

21 thoughts on “Acadia Pharmaceuticals: This Is Not a Pharmaceutical Company

  1. Your article is based on one way facts by quoting the professionals in the industry who disapprove and are biased against the pharma industry. Not one quote or interview with the majority that see positive benefits and outcomes. What about the families, Care Givers and patients that have had their lives turned around because of this medicine?
    This type of article is full of holes that is so typical and sensationalist to hurt the industry. Talk to families who suffer with PD and PDP everyday and you will get a better story. Thanks for confirming the false news and bias like CNN. The public knows better.

    • >”families, Care Givers and patients that have had their lives turned around because of this medicine?”
      Got links to such reports?

  2. I could only read some of the start and slim a bit more because it quickly became extremely obvious that you’re unfamiliar with science and medicine. You present a rather unpopular perspective as fact because the public bought into it. It’s not too far away going anti vaxxer on everyone. Be more careful.

  3. 70 year-olds die at over 5% per year, but Namzaric provides immortality? Your numbers are way off therefore the whole comparison is factually incorrect. You have been played by whoever provided you with this data.

    • “John Webbs,”
      We know the death rate with Nuplazid is increased based on the RCT on which it was approved. It is all over the FDA docs.

      What I’m measuring in the Namzaric comparator is whether or not the elevated death rate is simply a function of patients being old/sick. To that end, you would expect a higher death rate in other groups of patients who fall into the old/sick category. In other words, with other PD drugs. We don’t see that. Perhaps it is merely reporting bias — after all, Nuplazid is recently launched. But so is Namzaric, and with a DTC marketing budget that is readily 25x what Acadia can bring to bear. YET: We don’t see an elevated death rate reported on FAERS with Namzaric which strongly suggests it is unlikely to be reporting bias due to a new drug.

      Maybe this a subtle point but I tried to make it clear in the story’s text.

      So: If Nuplazid death rate was secondary to PD patients dying at a faster rate then we should see it with all PD drugs, to some degree.

      And If Nuplazid death rate somehow reflected a reporting bias in FAERS, we should see it with other recently launched drugs approved to treat disease in sick elderly patients — arguably sicker — like Namzaric.

      FAERS, as I indicated bluntly 2x in the piece, is not perfect by any means and this is why absolute values — their “death cases” are less informative than in comparison with other drugs. Even then, as I noted, I used the longer form case reports to drill down into “reaction” categories to ensure that I would get only reports where Nuplazid was named as a prospective cause of death.

  4. Isn’t Namzaric for ALZ? ACAD drug isn’t even approved for ALZ . Shouldn’t you compare it to it’s Parkinson’s comps? Just asking bud? Please advise.

    • “Curious,”
      I did. Look at the chart above the Namzaric comparison, the one with the nine “standard of care” PD drugs that frankly most every Nuplazid patient has been on prior to, or concurrent with, having it prescribed.

      Also, the longer form case reports make it abundantly clear that despite the label there is a great deal of overlap between ALZ and PD Nuplazid patients. Moreover, the ALZ patients are actively experiencing dementia episodes, in contravention to the boxed warning.

      Hope that clears it up

    • Curious,

      Sorry for delay in reply, I’ve been busy. It’s an antipsychotic — granted an atypical one a la Nuplazid — that’s primarily used in conjunction with manic depression. I tried to focus on drugs that are standard of care in PD, and that were either for treating it or like Levodopa, have been in use so long that whatever else they were used for has largely been forgotten.

  5. I trust you placed your short sell order just before publishing this deeply flawed, factually incorrect, half-truth tabloid-worthy “article”?

  6. Thank you for writing this important and fascinating essay. I was particularly disturbed by ACAD raising prices by 1/3 yoy while increasing payments to doctors.

  7. Generally a well researched and informed article. The original research into the FDA documents and approval process was very informative. I would not, however, use CNN as a source. Their articles were clearly biased and completely devoid of objectivity. This article has a clear bias, but at least provides meaningful analysis.
    The analysis stops when it comes to Avanir, however. The statement “Avanir’s off-label sales strategy initially increased the company’s revenue and propelled its stock price growth”, but the claim that this growth came from off-label sales is not supported by any evidence whatsoever. Similarly the claim “adverse publicity after CNN’s October story weighed heavily on Nuedexta sales last year” is unsupported, and ignores other significant factors including the reduction of the Avanir sales force by around 40%. Avanir is not Acadia, and Nuedexta (which has an excellent safety profile) is not Nuplazid.
    The greater story that this, and other stories like this, fail to explore is where the cost benefit in these drugs lies. It is clear that Nuplazid has an unclear cost/benefit ratio if it was free, but it costs $130M per year. This is necessary to cover the costs of the 99.6% of therapeutic techniques that fail, plus the endless series of clinical trials required to prove efficacy/safety of the drug. This article calls for further testing (and further cost).
    So what do you propose we do, Roddy Boyd? Should we just give up on Parkinson’s Disease Psychosis and let the patients suffer? Or do we continue down this path until we find a marginally better treatment and charge $100,000 per patient to cover another 10 years of failed investigations?

  8. Great article.

    Regarding Nuedexta, it is also provided off-label for pseudobulbar affect associated with Parkinson’s. I know because my father was prescribed after he mentioned to his neurologist that he found this symptom hard to handle. He began having serious cardiac issues soon after starting it, and they resolved after a lengthy process of treatment including cessation of the Nuedexta. I’m not suggesting that Nuedexta was the (only) cause, but the timing was curious. There are several cardiac adverse events associated with either drug in Nuedexta and also in the combination, which it should be stated is simply a mixture of 2 generics: Quinidine Sulfate and Dextromethorphan.

    At the time I looked at the FDA label and it had only been studied in relatively small trial populations in ALS and MS. As the typical patient ages within those diseases are much younger than in AD or PD, I found it troubling that it could have been provided so easily off-label.

    I can easily foresee an aggressive sales organization behind such a drug that takes shortcuts to patients. There was a good reason that Otsuka bought Avanir, and it wasn’t for R&D pipeline.

  9. It seems that whenever an article criticizes Nuplazid, there is an amazingly consistent negative response in the comments. I hope your investigative team will investigate who is making these comments and what their financial ties are to Nuplazid and Acadia.

    • Diane….. do a little digging into the writer of the article. Tied to short sell stock traders. There is gong to be overwhelming negativity when the article is flawed and the drug is not. Nuplazid helps, this buffoon of an writer does not.

  10. But, negative symptom schizophrenia, psychosis in dementia, psychosis in PD. If there is any hope in these areas, please, please keep this drug on the market.

  11. Who funded this hit piece?

    You should be ashamed of yourself for disseminating lies and smearing the reputation of a good company.

    Every expert that has looked at Nuplazid — e.g., Clive Ballard, Joseph Friedman, Melissa Houser, Conrad Tenebaum — is on record saying it is a safe and effective treatment. One research study even suggests Nuplazid is superior to the blockbuster Seroquel (see https://www.mdedge.com/neurologyreviews/article/171747/parkinsons-disease/pimavanserin-may-be-superior-quetiapine )

    And for those who care, most patients like Nuplazid and swear by it: https://www.investorvillage.com/smbd.asp?mb=523&mn=11291&pt=msg&mid=17761074

  12. I am glad that the there are organizations like the FDA that indeed engage in science and not this type of journalism. Will you be offering your readers the chance to see what the FDA has released and which has put to rest your claims.

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