Why pancreatic cancer is so deadly
The lifetime risk of developing it is about 1 in 63 for men, and 1 in 65 for women. This year, about 55,440 people will be diagnosed with pancreatic cancer, and the disease will kill about 44,330 people, according to the American Cancer Society.
About 95 percent of people with pancreatic cancer die from it, experts say. It's so lethal because during the early stages, when the tumor would be most treatable, there are usually no symptoms. It tends to be discovered at advanced stages when abdominal pain or jaundice may result. Presently, there are no general screening tools.
As people age, the risk of developing pancreatic cancer goes up. Most patients are older than 45, and nearly 90% are older than 55. The average age at diagnosis is 71.
Men have a slightly higher likelihood of developing pancreatic cancer than women, which may partly result from increased tobacco use in men. In the past, when men more commonly smoked than women, the gender gap was wider.
There is also a noted association with race: African-Americans are more likely to develop pancreatic cancer than whites. Doctors don't know why, but speculate that higher rates of men smoking and having diabetes, and women being overweight, may contribute to that association.
What are the types of pancreatic cancer?
The pancreas is an oblong organ that lies deep in the abdomen, and is an integral part of both the digestive and endocrine system. It secretes hormones to regulate the body and also digestive enzymes to break down food.
There are two types of pancreatic cancer: exocrine tumors and endocrine tumors.
Exocrine tumors are the majority of pancreatic cancers, and the most common form is called adenocarcinoma, which begin in gland cells, usually in the ducts of the pancreas. These tumors tend to be more aggressive than neuroendocrine tumors, the kind that Apple, Inc., co-founder Steve Jobs had, but if caught early enough they can be treated effectively with surgery.
Pancreatic neuroendocrine tumors constitute only 1% of all pancreatic cancers. They can be benign or malignant, but the distinction is often unclear and sometimes apparent only when the cancer has spread beyond the pancreas.
The five-year survival rate for neuroendocrine tumors can range from 50% to 80%, compared with less than 5% for adenocarcinoma.
More advanced tumors have a higher risk of recurrence, and can spread to the liver, said Dr. Steven Libutti, pancreatic cancer expert and director of the Montefiore-Einstein Center for Cancer Care in the Bronx.
Pancreatic cancer is usually controllable only through removal by surgery, and only if found before it has spread, according to the National Cancer Institute. Palliative care can help a patient's quality of life if the disease has spread.
Two drugs approved in 2011 may help patients with pancreatic neuroendocrine tumors. They are believed to suppress the blood supply and metabolism of the tumor cells. That's good progress since, the year before, the standard of care was chemotherapy, said Dr. Michaela Banck, medical oncologist at the Mayo Clinic, who treats patients with neuroendocrine tumors.
Everolimus, marketed by Novartis as Afinitor, received U.S. Food and Drug Administration approval to treat pancreatic neuroendocrine tumors and prevents transplant rejection. Potential side effects are serious, however: lung or breathing problems, infections and renal failure, which may lead to death.
Sunitinib malate, marketed by Pfizer as Sutent, is prescribed for the treatment of pancreatic neuroendocrine tumors, as well as, kidney cancer and GIST, a rare cancer of the bowel, esophagus or stomach. As with everolimus, there are risks to consider: it can cause liver problems and death.
Jobs underwent surgery to remove his tumor in 2004 and died in 2011. His seven-year survival after treatment is consistent with the average survival for these kinds of tumors, Libutti said.
If pancreatic cancers are detected early, that may increase the odds of survival, but it also depends on how aggressive the particular tumors are in a patient. If surgery leaves behind microscopic aggressive tumor cells, they can cause a recurrence of cancer.
Jobs also underwent a liver transplant in Tennessee in 2009, which is "cutting edge stuff" for when neuroendocrine tumors spread, said Dr. Maged Rizk, director of the Chronic Abdominal Pain Center at the Cleveland Clinic who specializes in gastroenterology and hepatology.
Do transplants help?
Because it's so rare, there isn't a lot of evidence to support the transplant as a cure; the procedure could extend life, but immunosuppression drugs may allow any remaining cancer to grow faster, doctors say. And a European study found that the majority of patients who underwent liver transplant for this type of tumor had recurrence of the disease.
But many pancreatic cancers are detected in later stages because when the tumor is small, it often does not produce symptoms. As they grow, adenocarcinomas can obstruct the ducts from the liver and cause severe back pain. Neuroendocrine tumors sometimes produce insulin, so a patient's first symptoms could be low glucose levels. But most tumors do not produce hormones, Libutti said.
There are two rare genetic syndromes -- multiple endocrine neoplasia type 1 (MEN1) and Von Hippel-Lindau syndrome (VHL) -- that increase the risk of pancreatic neuroendocrine tumors. Other than that, though, it's unclear whether having a family member with pancreatic cancer increases an individual's risk.
Pancreatic cancer struck former President Jimmy Carter's family hard. He lost his father and all of his siblings, brother Billy and sisters Ruth Carter Stapleton and Gloria Carter Spann.
The future of treatment
Researchers are working on better understanding the way in which pancreatic tumors grow and spread, Libutti said. There is also a lot of research focused on finding better treatments, targeted therapies, immune therapy, improving surgery and radiation therapy, according to the American Cancer Society.
"There are a number of agents that are being looked at in clinical trials that focus on pathways that may allow pancreatic cancer to evade normal processes," Libutti said.
Another line of research is focused on finding biomarkers of pancreatic cancer so that a simple blood or urine test could be developed. Unlike screenings for other conditions such as colon, breast and prostate cancers, there is no routine way to see whether a patient has a tumor in the pancreas.
The future of medicine to help people with pancreatic cancer will involve genetics, said Banck. This would involve matching a person's particular type of tumor using genomic information with treatment.
"What's going to make real difference in the future is the revolution of the genomic era," she said.
New Haven police make arrest after more than 100 K2 overdose calls
Two other people were arrested, including one New Haven man who police believe was involved, though they haven't confirmed a link, Chief Anthony Campbell said. The third person was arrested on unspecified federal charges, officials said.
Campbell said some of the people who overdosed gave detectives names to investigate. Sometime this week, police arrested John Parker, 53, on charges of possession with intent to sell. Campbell said police found 32 bags of K2, or spice, in Parker's home. He was also charged in connection with a February police operation.
The chief said Felix Melendez, 37, was also arrested. He is accused of possession of a controlled substance. Melendez was on probation for a prior conviction of selling K2 at the park.
Almost all of the overdoses occurred on the New Haven Green, a large downtown park. Home to a historic burial ground, the park gets lots of foot traffic and is family-friendly with "elm trees, lawn and fountains. There's even three churches inside the park," David Hartman, a New Haven Police spokesman told CNN.
An official said there were 114 calls for people needing to go to a hospital this week. Campbell said there were no calls so far Friday. At least 10 people overdosed more than once and were transported by ambulance several times, he said.
Laurence Grotheer, the spokesman for the New Haven mayor, said not all transports were ruled as overdoses, adding that some of the transported patients were determined to have suffered heatstroke.
But just because police have caught one suspected dealer and there were no problems Friday doesn't mean the crisis is over, the chief said. He said he hoped releasing the names and photos of the suspects as well as pictures of the K2 would prevent other people from overdosing.
"The evidence photos do not mean that we have seized all of the contaminated K2 that was out there," he said. He wanted citizens who had purchased drugs to be aware. "We want people to be warned that what they have could be extremely dangerous."
Authorities say they are unsure as to where the drugs came from, he said.
"We are continuing with the investigation to see how high up (the drug distribution goes) and trying to get to the source of it," he said.
Synthetic cannabinoids like K2 are man-made chemicals that can be either sprayed on dried plants and smoked or sold as liquids to be inhaled in e-cigarettes or other devices.
They can be anywhere from 2 to 100 times more potent than THC, the psychoactive ingredient in marijuana, researchers have said. That wide range is because the drugs that are used change from batch to batch.
Synthetic marijuana has caused similar mass hospitalizations in one localized area in the past. In May, for example, 25 people were hospitalized in one area of Brooklyn, New York, after having negative reactions to what was believed to be K2, police said.
First responders in New Haven initially suspected the drugs were laced with some form of opioid, so they used Narcan, which combats opioid overdoses, on the patients.
New Haven is in southern Connecticut, about 80 miles from New York.
Escape from the Mayo Clinic: How CNN reported the story
In its response:
Mayo refuses to acknowledge that the patient in this story, Alyssa Gilderhus, an adult, asked to be transferred, and that her family asked as well. Mayo claims that it had no idea Alyssa wanted to leave Mayo, even though there's written proof that she did, and Mayo had access to those writings.
Mayo completely misrepresents the nature of a meeting held between CNN staffers and Mayo staffers in March. Mayo insisted that the meeting remain off the record, yet now says that the meeting was on the record. CNN has written proof that Mayo's public statements regarding this meeting are false.
Mayo refuses to acknowledge that although Mayo doctors said Alyssa was desperately ill and needed to stay in the hospital, less than 12 hours after Alyssa left the hospital, Sanford Health, a teaching hospital in South Dakota, said that Alyssa did not need to be hospitalized and sent her home.
Mayo fails to discuss that while it said it would be dangerous for her to go home, she has flourished in the year and a half since she left Mayo. She no longer needs physical or speech therapy and will start college in a few weeks.
Alyssa says Mayo's response has further traumatized her, and that she fully supports CNN's article, which she says shed light on what she describes as her horrific treatment at Mayo.
Mayo's criticisms of CNN reveal its own inaccurate and inconsistent statements about what happened during Alyssa's hospitalization after, at age 18, she suffered a burst aneurysm on Christmas Day, 2016.
Mayo has contradicted one of its own nurses about the day Alyssa left the hospital and literally laughed off a request from a lawyer representing Alyssa who asked that she be transferred to another hospital. A top Mayo executive expressed regret at how his own staffers handled the situation.
Mayo also has made critical misrepresentations about the ground rules for a four-hour meeting five Mayo staffers had with the authors of this story, Elizabeth Cohen and John Bonifield, on March 28 at Mayo offices in Rochester, Minnesota.
After CNN released its story on Monday, Mayo said that the meeting had been on the record, and CNN should have published the details.
However, CNN has proof in writing that before the story came out, Mayo officials had demanded that the meeting be considered off the record and that the information should not be reported publicly. (Highlights in emails were added by CNN.)
CNN and Mayo met initially on the condition that the information be considered off the record -- that the information not be published or aired. A release form signed by Alyssa stipulated this condition. That signed form was approved by Mayo and was on their letterhead.
After the meeting, Alyssa expressed to CNN that Mayo could put the information from the meeting on the record and make it public. CNN then asked Mayo for its permission to put the information on the record. At first, Mayo consented to putting the information on the record.
"The decision to use what was said during the in-person conversation is ultimately up to CNN and the patient, not Mayo," Kelley Luckstein, a Mayo senior communications specialist, wrote to CNN. "If you do use information from the meeting, we'd like to have it attributed to the specific person from the meeting, so we'd be happy to review the information if you don't recall who said what during the meeting."
But the next day, Luckstein changed her mind. As CNN's emails show, Mayo staffers ultimate refused to allow information from the meeting to be made public.
"I consulted with our legal team to talk through this further," Luckstein wrote to CNN on April 25. "Based on the form, Mayo and CNN do not have the authority to publicly release any background information provided during the meeting."
After CNN pressed further to have the information from the meeting put on the record, Luckstein reiterated that Mayo wouldn't allow that to happen.
"Per the signed authorization form, Mayo is not permitted to 'disseminate, publish or otherwise publicly disclose' any confidential information,' " Luckstein wrote to CNN on April 27.
Mayo continued to refuse to further discuss Alyssa's case, even after she signed a medical information release known as a HIPAA release form provided by Mayo, which explicitly permitted Mayo to discuss Alyssa's case on the record. When pressed by CNN to have the information put on the record, Luckstein's colleague in the public relations department, Ginger Plumbo, said no again.
"As you know, we consented to the face-to-face meeting with the understanding that information would not be aired publically, and with hopes that you would reconsider your decision to share the story," Plumbo wrote to CNN on May 7.
Why does all this matter?
On Wednesday, Mayo officials themselves made parts of this meeting public by putting out a press release stating that CNN failed to investigate or include the information provided by Mayo, knowing that Mayo itself was the one who precluded CNN from reporting the information.
After we published our series, Mayo revealed part of what was discussed in our meeting to a journalist from Minnesota Public Radio to produce, as Mayo CEO John Noseworthy wrote to Mayo trustees, a story that was "expected to address Mayo's commitment in caring and protecting the patient."
Since Mayo has now made this information public, and Alyssa previously agreed to make it public, CNN will now speak about this information on the record.
There are four important points.
First, Mayo has been inaccurate and untruthful about what transpired during the March 28 meeting. Officials' own claims contradict what their staffers wrote -- clearly and unequivocally -- in emails to CNN.
Second, nothing that was stated in the March 28 meeting changes CNN's story.
Third, Mayo has continued to focus on what officials perceive as inappropriate behavior by Alyssa's mother, instead of on the allegations that Alyssa's rights as a patient had been violated. Mayo has not explained why a mother's allegedly inappropriate behavior would impact the rights of an adult patient.
Fourth, while Mayo has said that Alyssa has been their top concern, Alyssa says she was treated as an "object" by Mayo and that their attacks on CNN's story have traumatized her even more.
What Mayo didn't say about the March 28 meeting
During the meeting, Mayo staffers made factual mistakes and shocking comments.
Mayo staffers denied that Alyssa and her family requested that she be transferred -- until CNN presented proof.
In its response to CNN's reporting this week, Mayo claims the family never asked for Alyssa to be transferred to another hospital.
Mayo staffers also made that claim at the March 28 meeting.
CNN asked Mayo staffers about a letter an attorney had written on Alyssa's behalf asking for "an expedited transfer."
At first, the Mayo staffers denied that such a letter existed. CNN asked if they were sure, and they said yes. CNN asked again if they were sure, and they said yes. CNN asked again.
"I don't think there was a letter," said Sherry Hubert, vice chair, Mayo Clinic Legal. "It was just a phone call. And it was not requesting transfer."
CNN then showed the Mayo staffers the letter that Karie Rego, an attorney admitted to the California Bar, wrote to a Mayo lawyer.
"Oh yes, there was a letter," Hubert said.
CNN asked what they thought about the letter at the time they received it.
The staffers laughed.
CNN asked why they were laughing.
"The lawyer letter wasn't official," said Dr. Robert Cima, who, as chair of the Rochester Hospital Practice, serves as the hospital's medical director.
CNN asked why they didn't consider the letter from Rego "official."
The staffers laughed.
"You should call her a 'lawyer,'" Cima said, making air quotes around the word "lawyer."
CNN asked him to explain. Rego was admitted to the California Bar in 2000, where she's now an inactive member. She was a partner at McDermott Will & Emery, a leading international law firm, for eight years, according to the firm. She's spoken at national conferences, including at a meeting of the American Health Lawyers Association.
She volunteered to be a patient advocate for Alyssa while she was at Mayo.
"She's not really a lawyer," Cima said.
CNN asked him what he meant, but the staffers continued to laugh and declined to explain why they were laughing, or why they didn't take Rego's letter seriously.
Prior to Rego's letter, Alyssa and her family say they made repeated requests of doctors and nurses for Alyssa to be transferred to another hospital.
Also at the meeting, Mayo staffers said Alyssa never asked to be transferred, and neither did anyone in her family. When CNN mentioned that Alyssa and her family had asked to leave Mayo, the staffers said that this was the first time they'd heard that.
Then they said that because they were concerned about the mother's behavior, they were closely monitoring the mother's social media posts. A February 23 post on the public Facebook page of Alyssa's mother, Amber Engebretson, clearly stated that the family wanted Alyssa transferred.
A Mayo executive expressed regret about the handling of Alyssa's situation.
Ken Ackerman, administrator of Saint Marys Hospital, Mayo Clinic, said at the meeting that he wished the doctors treating Alyssa had come to him sooner as the conflicts with the family were escalating.
"I have regrets that that Bob [Cima] and I were not brought in earlier," he said. "A third party could have de-escalated the tension."
Mayo's Hubert interrupted Ackerman. "You're being too hard on yourself, Ken," she said.
A Mayo official made a major mistake about Alyssa's age.
At the outset of the meeting, Cima, the only physician present, said that Alyssa was a minor, and proceeded to give an analysis of her stay based on her being a minor.
Laws governing minors and adults in these situations are very different.
CNN corrected Cima and said Alyssa was 18 -- a legal adult -- during her entire hospital stay.
Cima said that CNN was wrong and proceeded to refer to her as a minor.
CNN again corrected Cima, and he again stated that we were wrong and he was right.
Finally, one of his colleagues corrected him and Cima brushed it off.
"She was in high school. She was a kid," Cima said, and continued to refer to Alyssa as a "kid" throughout the meeting.
Mayo contradicted police and its own nurse on a crucial issue.
At the meeting, Mayo staffers said Alyssa was abducted from the hospital, even though Alyssa says she left of her own free will, and Rochester police agreed with her, saying there was no abduction.
In the police report, a Mayo nurse who witnessed Alyssa's departure from Mayo said, "Alyssa seemed to feel safe getting into the vehicle and had no hesitations."
Mayo staffers misunderstood the use of a hospital ethics committee.
CNN interviewed four experts specializing in medical ethics or law, all of whom now, or in the past, have worked for large and well-respected academic hospitals.
These experts said that when family and staff get into conflict, it's standard operating procedure to call on the hospital ethics committee to help sort things out.
At the March 28 meeting, the Mayo staffers said the hospital's ethics committee was never consulted.
Ackerman, the hospital administrator, said ethics committees were not meant to handle such conflicts.
Mayo staffers wouldn't respond to Alyssa's accusation that a doctor dismissed her wishes to have a friend with her during an exam and then told Alyssa the teen who had raped her years earlier was trying to reach her.
During her hospital stay, Alyssa asked that a family friend, Joy Schmitt, stay with her while a doctor did a physical examination. Both Alyssa and Schmitt say the doctor told Schmitt she had to leave.
Schmitt left, leaving Alyssa was alone. Then, Alyssa says, the doctor told her that the teen convicted of sexually assaulting her a few years before -- her biological father's wife's son -- had been calling the hospital looking for her. She said she cried when the doctor brought up the name of her rapist, but the doctor kept talking about him.
Alyssa said the doctor's comments traumatized her.
"It was like going back to the day it happened," she said.
At the March 28 meeting, CNN asked about this, and the staffers said they didn't know anything about it, but would get back to CNN. They never did.
CNN is publicly mentioning the rape now with Alyssa's permission.
Mayo's accusations against CNN
We'll take Mayo's criticisms of CNN one by one. The quotes below are from a letter that Chris Gade, chair of Mayo's Department of Public Affairs, wrote to Rick Davis, CNN's executive vice president of news standards and practices, on Wednesday. Mayo posted this letter on its website.
Mayo says CNN's Cohen and Bonifield "chose to disregard and not investigate key facts that were shared with them." They then listed the following items:
"The role of the biological father in making care decisions for his daughter during her hospital stay when the mother was unavailable."
At the March 28 meeting, Mayo staffers told CNN that they wanted Alyssa's biological father, Jason Gilderhus, to agree to become Alyssa's guardian and make medical decisions for her.
Ackerman said he and other staffers met with Jason on the night of February 25 and "he was a very reasonable guy."
Jason has a significant criminal record, with two assault convictions, including one for domestic assault, in addition to convictions for DWI, disorderly conduct, unspecified misdemeanors and other charges. The convictions CNN has seen are from 1995 to 2004.
At the meeting, CNN asked the Mayo staffers whether they were aware of Jason's criminal record before encouraging him to become Alyssa's guardian. They did not answer.
Mayo staffers said they were aware that when Alyssa was 16, she was sexually assaulted by her biological father's stepson. Alyssa says the rape occurred in her father's home and while her father was there. The teen was later convicted.
Alyssa told CNN that after the assault, she did not want to go to her biological father's house.
CNN made repeated unsuccessful attempts to reach Jason.
"Allegations of the mother's abuse of the patient" and "Mayo reported suspected abuse of the patient, a vulnerable adult, to the County as part of our statutory reporting requirement and reported again when the patient was removed from the hospital without a safe discharge plan."
At the March 28 meeting, Mayo staffers told CNN that during Alyssa's hospital stay, her relatives reported that her mother and stepfather, Duane Engebretson, had abused her.
CNN asked if the staffers were sure that it was relatives -- plural -- or just one relative who made this accusation. The staffers said they were sure it was more than one relative. CNN asked twice more if they were sure it was more than one relative, and twice they said they were. CNN asked the staffers to check their records, and they apologized and corrected themselves and said it was just one relative.
They said that an elderly relative made these accusations on two occasions. CNN told the staffers that, according to this man's daughter, he has dementia. The daughter said he was institutionalized at one point, and he has pushed her and has threatened to kill family members. The daughter said she'd recently run into her father at a store, and he got the store clerk, brought him to where she was shopping, and pointed at her and said she was a terrible daughter.
Plumbo, the Mayo public relations specialist at the meeting, said the staffers were unaware that the elderly relative had dementia, but they were obligated to report his accusations to county authorities.
Contrary to what Mayo has said in its responses to CNN's story, CNN did investigate these claims. CNN asked county authorities for records in this case, but the authorities declined to release any documents or make any comments, citing privacy concerns.
The Rochester Police report has details of interviews with four Mayo staffers who cared for Alyssa. None of them make any mention of abuse. CNN interviewed two Rochester Police officers who handled the case, and both said that Mayo staffers did not mention abuse to them.
"Mayo never sought to be appointed as a guardian or make decisions for the patient; instead, Mayo notified the County of the patient's vulnerable adult status and asked for assistance in identifying a decision maker."
CNN did report in our previous story what Mayo staffers told the Rochester Police Department.
The social worker told the police she'd been working with adult protection services in two Minnesota counties "trying to get emergency guardianship" but had been unable to get court orders to do so.
As we reported, an Olmsted County Adult Protective Services official told police that "Mayo was requesting [assistance] in gaining guardianship of Alyssa because they were concerned for the mother's mental health and the medical decisions that were being made for Alyssa."
CNN also reached out to the two police officers who worked on the case.
Brian Smith, the Rochester Police officer who responded to Mayo's 911 call the day Alyssa left Mayo, said a Mayo social worker told him she'd been working for a week or two to get a Minnesota county to take guardianship over Alyssa.
"The county would have guardianship over her and would make decisions for her," he told CNN.
If that happened, Alyssa most likely would have stayed at Mayo, as she was already receiving treatment there, Smith said.
Sherry Bush-Seim, a Rochester Police investigator who also worked on the case, spoke with an official at one of the county adult protection agencies. She said it was also her understanding that Mayo wanted the county to take guardianship of Alyssa, or that perhaps Mayo itself wanted to directly take guardianship of Alyssa.
"Mayo never denied a request from the family to transfer the patient to a different facility."
At the March 28 meeting, the Mayo staffers said neither Alyssa nor her family members ever asked for her to be transferred.
CNN informed them that Alyssa, her stepfather and her grandmother all said they asked repeatedly for her to be transferred.
"This is the first we're hearing about this," said Anita Milburn, social work manager, Saint Marys Hospital, Mayo Clinic.
During the meeting, Plumbo, the Mayo public relations specialist, and Ackerman, the Mayo administrator, said because they were concerned about Amber's behavior, they were vigilantly watching Amber's social media during her daughter's hospitalization.
On February 23, Amber posted on her Facebook page, which was public at the time, that they wanted to transfer Alyssa out of Mayo. "They refuse to let her go. ... We cannot transfer [Alyssa] out or get her discharged," she wrote. "No one has any say in [Alyssa's care] and she is basically a prisoner of Mayo."
After the meeting, CNN emailed Plumbo and asked her why she was unaware of the family's desire to have Alyssa transferred if they had been closely monitoring Amber's Facebook page.
Plumbo didn't answer.
As noted above, when CNN asked about the letter from the attorney, the staffers denied it and then laughed it off, saying they didn't take it seriously.
"Mayo did not arbitrarily remove the mother from the hospital; instead she was removed after she exhibited escalating disruptive and aggressive behavior that interfered with the care of her daughter and resulted in multiple staff members reporting fear for their safety. A team of Mayo staff members also met with the mother and stepfather to explain why she was removed and they expressed understanding."
In its stories earlier this week, CNN never said nor implied that Amber was "arbitrarily" removed from the hospital.
CNN published Mayo's full on-the-record statement about why they asked Amber to leave.
"Our care teams act in the best interests of our patients. As a general practice, this includes sharing information with family members and facilitating family visits and interactions with patients and their care providers when the patient is in our care. However, in situations where care may be compromised or the safety and security of our staff are potentially at risk, the family members' ability to be present in the hospital may be restricted," they wrote.
At the March 28 meeting, the Mayo staffers said Amber was removed because she was physically and verbally abusive to staffers.
None of the staffers present at the meeting had taken care of Alyssa, but they said they'd looked through her medical records and spoken to staff members who did care for her.
When CNN asked for specifics about the physical abuse, the staffers did not give specifics but just said the staff was "fearful" of Amber. When CNN asked again for specific incidents of physical abuse, Cima, the Mayo doctor, said it didn't matter, because health care providers shouldn't be abused or fear abuse in any way. When we asked again for specific incidents, they said that Amber "grabbed" a doctor's shoulder and he feared she was going to "throw a punch." We asked about the nature and circumstances of the "grabbing," they said there were no more details in the medical record.
CNN asked if we could speak to the health care providers who were involved with her care, and they said none of them would talk because they feared Amber.
When asked about the verbal abuse, the staffers said Amber kicked staff out of a room in a manner that they characterized as verbal violence.
Amber said a social worker discussed private financial information in Alyssa's hospital room within earshot of visiting friends and family, and that she asked the social worker to stop.
As CNN reported in its stories, Amber says she never touched any Mayo staffer and that at one point during a meeting she told the staff she felt like they "don't give a f***," later apologizing for her language.
CNN asked whether staffers had spoken to Amber about her behavior before they kicked her out. They said there was no record that anyone had done so.
As reported in CNN's story, Amber and Duane, Alyssa's mother and stepfather, say they never received an explanation for why she was being kicked out, either at the time or since.
"Our care team provided appropriate pain management according to the pain needs of the patient and was concerned when the mother requested opioids for her daughter so that the mother could get some sleep."
As reported in our story, when Alyssa entered the rehab unit at Mayo, she'd had four surgeries in the past month, with the last one just a few days before.
According to the Mayo Clinic's website, opioids are "critical for post-surgical pain management."
At the March 28 meeting, Mayo staffers told CNN that Alyssa didn't need pain medication because she reported having no pain.
Alyssa told CNN that during this immediate post-surgical period, she was only pain-free when she'd received a dose of painkillers. When the drugs wore off, she said she was in pain that was so severe she would cry.
At the March 28 meeting, the Mayo staffers said that Amber asked for pain medication for her daughter so that her daughter would be quiet and Amber could get some sleep.
Amber denied asking for pain medication for her daughter so that she, Amber, could sleep. She said she wanted pain medication because her daughter had just had four surgeries in the past month and she was crying from the pain.
Other accusations made by Mayo at the meeting
In the Wednesday letter to CNN's executive, Mayo said they found the following items "disturbing."
"The reporters' firm commitment to a pre-determined narrative despite contrary facts."
CNN did not have a "firm commitment to a pre-determined narrative." CNN spent more than 17 months reporting this story, exploring every angle and accusation made by the family. CNN examined documents from three law enforcement agencies; interviewed four law enforcement officers who handled the case; scoured hundreds of pages of Alyssa's medical records from two hospitals; interviewed more than six lawyers and medical ethicists; spoke to members of Alyssa's extended family and a family friend; and made four visits to Minnesota to conduct in-person interviews.
"Insisting that Mayo Clinic be prepared to defend itself instead of pursuing an accurate, fact-based story."
CNN gave Mayo ample time -- nearly a year and a half -- to tell us their version of what happened during Alyssa's hospital stay. CNN contacted Plumbo, the Mayo public relations officer, around early March, 2017. We then proceeded to have conversations with Plumbo until just days before the story published.
CNN worked with Mayo officials as they continuously changed their mind about whether they would speak with CNN.
First, Plumbo said Mayo wouldn't speak even if Alyssa signed a HIPAA release form. Months later she said Mayo would do an on-the-record interview only if Mayo health care providers could first examine Alyssa and see if she was mentally competent to sign such documents. Alyssa declined to be examined by Mayo doctors.
Then, when CNN pointed out that Alyssa's current health care providers at another hospital allowed her to sign her own medical forms, Plumbo backed off that request.
Later, Plumbo said Mayo would do an on-the-record interview with CNN if Alyssa signed a HIPAA release form.
Then when Alyssa did sign that form, Mayo declined to do the interview.
"Contacting direct patient care staff with veiled threats and asking them to breach confidentiality in order to corroborate information. This would be a potential legal breach of the patient's confidentiality for them to do so."
CNN texted and emailed several members of Alyssa's care team so that they could describe what happened during the hospital stay. No threats -- veiled or otherwise - were made.
"Contact with the patient's family prior to their removal of the patient from the hospital, demonstrating an early and unwavering faith in the patient's mother's viewpoint and prioritizing pursuit of a story over the well-being of a vulnerable adult."
While Mayo has repeatedly said that the CNN story would harm Alyssa, Alyssa disagrees. She spoke to CNN twice in person and many times over the phone in preparation for our stories.
"It didn't harm me at all. It got the word out there that this happens. It shed light," she said.
Duane also said that he fully supports the CNN story and is grateful for it.
She said the horror has come from Mayo itself disputing CNN's story.
CNN did not have an "unwavering faith" in anyone's viewpoint, which is why we spent nearly a year and a half investigating the story.
"Despite our attempts to share our concerns with the News Standards and Practices unit, and promises of fair and balanced reporting, the story that was published was factually incomplete and wholly inaccurate."
Mayo has failed to point out any facts that CNN got wrong. CNN has made no corrections or changes to the story.
Alyssa has the last word
On Thursday, Alyssa expressed sadness that Mayo was continuing to attack her and her family.
She wondered why they were focused on her mother.
She was an adult. Why would her mother's perceived bad behavior mean that Alyssa was kept in the hospital against her will? She said it just doesn't make sense.
"This is about me, not my mother," Alyssa said.
On Thursday, Mayo public relations circulated court records from late last month and earlier this month showing that Amber had tested positive for methamphetamines, and that a judge had stripped her of custody of Alyssa's five younger half-siblings, who are minors, after it was found she had abused them.
The children were taken away from their mother, and sent to live with their father, Duane, who has separated from his wife.
CNN learned about the legal proceedings against Amber and that the Engebretsons had separated after we published the articles on Monday.
The documents that Mayo circulated include the names and birth dates of her siblings.
Alyssa said she thinks Mayo continues to attack her mother because they want to deflect from the main issue: that, according to Alyssa and her family, they refused to let her leave the hospital and she had to escape.
"They're trying to create a smokescreen. I wish they would stop," she said. "This is my life. And instead of treating me like a human being, they're treating me like an object."
Editor's note: The original version of how CNN reported this story published on August 13.
This story is based on law enforcement documents from three police agencies in Minnesota; medical records from Alyssa Gilderhus' hospitalization at the Mayo Clinic in Rochester and her visit to an emergency room at Sanford USD Medical Center in South Dakota; a letter from and an interview with an attorney who advocated for Alyssa during her stay at Mayo; correspondence between Mayo and Alyssa's family; and interviews with Alyssa, members of her family, a family friend, law enforcement officials and a former member of a Mayo Clinic board.
CNN first spoke with Alyssa's mother, Amber Engebretson, during the final days of her daughter's stay at Mayo. She informed CNN that she and her husband would be taking Alyssa out of the hospital shortly before they did so.
While reporting this story, the authors had multiple conversations over many months with Ginger Plumbo, a spokeswoman for the Mayo Clinic. The authors also met with Plumbo and four senior Mayo officials on the condition that the information provided would be off the record.
Plumbo wrote in an email to CNN that Mayo staffers consented to the off-the-record meeting "with hopes that [CNN] would reconsider [its] decision to share the story. We feel that going on camera or audio disclosing the details about this case and the complex family situation are not in the best interest of the patient or the family."
Before that meeting, Plumbo told CNN that Mayo officials would answer CNN's questions on the record if Alyssa signed a privacy release form. Plumbo provided the form.
After the meeting, Alyssa signed the form, but then Plumbo said Mayo officials would not answer CNN's questions on the record and instead provided a statement, presented here in its entirety:
"Following careful review of the situation in question, we have determined that the version of events provided by certain patient family members to CNN are not supported by the facts nor do they track with the direct observations of numerous others who were involved. We feel we have provided CNN with more than ample information to support our findings and are deeply disappointed that the producers have chosen to pursue a false story based on a pre-determined narrative. We will not address these questionable allegations or publicly share the facts of this complex situation, because we do not believe it's in the best interest of the patient and the family.
Mayo Clinic is committed to the safety and wellbeing of all of the patients we treat. Our internal review determined that the care team's actions were true to Mayo Clinic's primary value that the patient's needs come first. We acted in a manner that honored that value for this patient and that also took into account the safety and well-being of the team caring for the patient."
Prior to sending the above statement, Plumbo sent CNN this statement regarding Mayo's decision to ban Alyssa's mother from the hospital:
"Our care teams act in the best interests of our patients. As a general practice, this includes sharing information with family members and facilitating family visits and interactions with patients and their care providers when the patient is in our care. However, in situations where care may be compromised or the safety and security of our staff are potentially at risk, the family members' ability to be present in the hospital may be restricted."
First generic EpiPen gets FDA approval
The company Teva Pharmaceuticals gained approval to market the new generic drug, according to an announcement from the FDA on Thursday.
Brendan O'Grady, executive vice president who heads North America Commercial at Teva, noted in an emailed statement Thursday that the approval "marks an important step forward in bringing our patients additional prescription medications that have met the FDA's rigorous standards."
"We're applying our full resources to this important launch in the coming months and eager to begin supplying the market," the statement said.
No details are available regarding the cost of the new generic or precisely when it will be available.
'A lower-cost option'
The approval of the generic drug comes after EpiPens were added to the FDA's drug shortage list in May and two years after the maker of EpiPen, pharmaceutical company Mylan, increased costs of its product by more than 400%, leading to public outrage.
The newly approved generic offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen.
"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Dr. Scott Gottlieb said in the announcement.
"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," he said.
EpiPen is an auto-injector that delivers epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles in the airways and tighten blood vessels. It can open the airways and reduce swelling during a severe allergic reaction.
Epinephrine injection is used along with emergency medical treatment for life-threatening reactions caused by allergies to insect bites or stings, foods, medications, latex or other causes.
Yet "the path to developing generic drug-device combination products like this one is challenging," Gottlieb said, because combination drugs consist of two parts: the drug, such as epinephrine, and the device, such as the auto-injector.
"We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition," Gottlieb said.
This effort is part of the administration's overarching aim to "remove barriers to generic development," as outlined in its Drug Competition Action Plan, announced last year.
"We're especially committed to the development of generic copies of complex products," Gottlieb said. "These products can be hard to copy, and therefore sometimes don't face timely generic competition once patents and exclusivities are no longer a block to approval."
He added that "we're advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritizing review of many complex generic drug applications."
What this means for back-to-school planning
Before the new generic, the only other FDA-approved alternatives to EpiPen were the brand products Auvi-Q and Adrenaclick. The newly approved option made by Teva is the only approved non-brand option.
The American Academy of Allergy, Asthma, and Immunology is "very pleased" with the approval of the new generic, said Dr. Robert Wood, president of the academy and director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore.
"Any measures that can improve the availability and costs of these medications is a real benefit for our patients," Wood said.
"There have been recent concerns about shortages of EpiPens, which has been especially an issue as families are refilling prescriptions for back-to-school planning," he said. "We strongly support any measures than can help provide these lifesaving medications in a more cost-effective manner, especially given the concerns about the shortages of EpiPens."