26 Jul Phase 3
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"Phase 3"Written by
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Estimated reading time — 6 minutes
My name is Dr. Miranda Solomon. Until yesterday I was a clinical research scientist for Apollyon Pharmaceuticals. I believe it is morally imperative that I warn the public about a new drug that will soon be available. DO NOT, under any circumstances, take Cyvalopram, which is being marketed as an anti-anxiety medication under the trade name Calmoprax in the United States. Patients enrolled in clinical trials of this drug experienced severe side effects, including death. Worse than death, really.
The animal trials were promising. So were the initial phases of human clinical trials. Of the small groups who initially took the drug, only 8% of the patients experienced side effects, all of which were very minor: headaches, nausea, the usual things that are often listed in the warnings for many medications. It wasn’t until Phase 3 of the trials that the side effects became troubling.
The company enrolled a total 2453 patients at four clinical research sites across the United States. I made frequent visits to each site in order to monitor the trials. The problem began at Site 2.
A 55-year old male began experiencing severe insomnia after taking a 100mg dose of Cyvalopram once daily for six weeks. He checked into the emergency room of the county hospital, reporting that he hadn’t slept in ten days. He was also experiencing hallucinations and psychosis related to this lack of sleep. Upon admission to the hospital, he was prescribed several different sedatives, often in combination, none of which were effective. Within twelve hours, he fell into a coma. Brain death was pronounced five days later, and he was removed from life support. Vital functions ceased, and a resident called the time of death. The patient’s body was transported to the morgue. However, employees in the morgue reported hearing strange noises from one of the units several hours later. They opened the unit, and patient crawled out, disoriented and incoherent. This incident was captured on morgue security cameras, and I have attached the video file to this email.
The patient was rushed back to the emergency room, where he became agitated, and had to be restrained. He became increasingly violent, despite multiple attempts at sedation, eventually breaking free of the restraints and injuring several hospital staff members. Hospital security officers fired a total of eight shots at the patient, and he was pronounced dead (again).
I obtained the patient’s medical files, including the autopsy report. The initial cause of death was listed as “Undetermined–possibly related to acute insomnia.” The attending physician in the emergency room added a note that the resident who first pronounced the time of death must have made an error and had been put on probation. The autopsy findings included apparent massive alterations in brain chemistry, which left the patient’s body unable to produce any of the hormones required for sleep, or other normal functions.
Please see the attached file, “CRF0058469,” for greater detail about this incident, including the clinical trial records, patient medical records (including autopsy report), witness statements, and photographic records of the injured hospital staff members.
I presented this information to my superiors at Apollyon. Manufacture of the drug was halted, and a massive investigation began, the details of which can be found in the attached file, “Investigation.” No adulteration, contamination, or other problems with the manufacturing process were discovered. The R&D group was unable to determine whether the drug could have caused the hormonal changes the patient experienced. The clinical trial had continued during this time, with a warning for the staff to watch for any patients reporting insomnia, and remove them from the study. Manufacturing resumed, and at one meeting I attended, the Marketing VP said, “A lot of drugs cause insomnia. We’ll just put it in the list of side effects.”
I reported this incident to the FDA, and sent my contact all of the information related to it. He agreed with the company’s assessment that the incident “may have been an isolated adverse reaction,” and that “the evidence was inconclusive to support the hypothesis that the patient’s symptoms had been caused by Cyvalopram.” I received similar responses when I escalated the report to his superiors.
Two weeks later, Site 1 reported removing a patient from the study due to self reports of insomnia. This patient was a 23-year old female who reported three consecutive days without sleep. She had been taking a 50mg dose of Cyvalopram once daily for four weeks. Site 1 staff members told her to stop taking the drug, and sent her to the nearest emergency room for evaluation. She was found to be healthy, and sent home. However, the next day, her mother found her collapsed on the floor of their living room, apparently in a coma. She was transported back to the hospital, where she remained in a coma for six days, until she was declared brain dead. Cessation of all vital functions also ceased shortly thereafter. However, within four hours, she awoke, though she was incapable of coherent speech. She quickly became agitated and violent, and was restrained and moved to the psychiatric ward of the hospital. She was then removed to a maximum security psychiatric facility, where she remains. Please see the attached file, “CRF0098537” for greater detail.
In total, 27 incidents were reported, each with the same presentation and clinical course (see attached files). Though this is only 1.1% of the total study population, I find it deeply disturbing. I presented my concerns to my superiors, and to the FDA, but I was told that the percentage fell within acceptable limits for risk.
I disagree. If the study numbers are extrapolated, and the percentage applied to the entire population of the United States (approximately 313.9 million people, as of this writing), the projections become appalling: 3.5 million people could be affected by this drug in such a manner as I’ve described.
Despite all of this, Cyvalopram was approved for sale yesterday. The company has projected that it will break all of the previous sales records for anti-anxiety medications.
I’ve presented this information to government authorities, and to all of the mainstream media outlets. My phone calls and emails have been ignored; the reporter I spoke with in person at my local Fox affiliate laughed me out of her office. You’re my last hope of making this information known to the public. I hope you will post my remarks, along with the attached evidence, to your website. I have also created a video record of these remarks, which can be found at the link listed below.
I doubt you’ll hear from me again; I believe I’m being watched and followed by Apollyon agents. Please make sure the public knows not to take Cyvalopram.
Miranda Solomon, PhD
Clinical Research Scientist II
“This email, along with the files and video statement, was posted to an “alternative news” website last night,” the Marketing VP explained to the group of executives, after they had finished watching the video. “Mostly the site is full of crazy conspiracy theories, like “the President is a reptilian alien” and other bullshit, but this has been getting some traction. The video version of her statement has over 100,000 views on YouTube so far.”
“I’ve already got the lawyers on it,” the CFO said. “They’re going get YouTube to take the video down, and they’re making the usual threats to the conspiracy site.”
“But it’s out there,” the CEO said. “People have already seen it; copied the information to other places. What are we going to do about that?”
“Discredit her?” the Marketing VP suggested. “What do we have on her? Does anyone even know where she is?”
“Representatives of the company stopped by Dr. Solomon’s house early this morning,” the CFO said. “They found her dead. Gunshot wound to the head.”
“Self inflicted?” the CEO asked.
“Undetermined. They couldn’t find a gun anywhere.”
The CEO looked around the conference table. “Ok, which of you did it?” The executives laughed, though no one took credit.
“The team left a gun there to make it look like suicide,” the CFO said. “The local cops are so inept that they won’t look any further. Once she’s discovered, we’ll release some statement saying she’d been behaving erratically and was put on leave to seek counseling or something. PR, get your team started on that.” The VP of Public Relations nodded.
“Now,” the CFO continued. “I have some projections regarding the effect this could have on sales.” He clicked over to a PowerPoint presentation, and guided the group through several slides full of charts and graphs. “In the end, I predict only a 9% revenue loss for this product in the coming fiscal year, when compared to initial projections. That decreases to 7% the following year, and so on, as people forget about all this.”
“We will have to add “coma” and “psychosis” to the list of rare side effects, but overall, I think we should be fine,” the Marketing VP said.
“What a fucking shitstorm,” the CEO said. “But I guess that’s all we can do. Should we have breakfast brought in?”
Credit To – Amanda Butler
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