&amp;amp;amp;lt;a href=”http://s3.documentcloud.org/documents/714334/2013-06-04-pub-letter-to-ani-re-reglan.pdf”&amp;amp;amp;gt;2013 06 04 PUB Letter to ANI Re Reglan (PDF)&amp;amp;amp;lt;/a&amp;amp;amp;gt; &amp;amp;amp;lt;br /&amp;amp;amp;gt; &amp;amp;amp;lt;a href=”http://s3.documentcloud.org/documents/714334/2013-06-04-pub-letter-to-ani-re-reglan.txt”&amp;amp;amp;gt;2013 06 04 PUB Letter to ANI Re Reglan (Text)&amp;amp;amp;lt;/a&amp;amp;amp;gt;
A new policy for force feeding hunger strikers at the US Naval Base at Guantanamo Bay includes the recommended use of a controversial drug that may cause serious neurological disorders, including one that mimics Parkinson’s disease.
The UK-based human rights group, Reprieve, filed an incident report this week with the US Food and Drug Administration (FDA) demanding an immediate investigation into the use of the brain-altering drug, and asking the agency “to take all possible measures to prevent further use of metoclopramide in force-feeding at Guantanamo”.
Al Jazeera first documented the use of metoclopramide last month in an exclusive report about the government’s revised Standard Operating Procedures (SOPs) to deal with a massive hunger strike entering its fifth month.
More than 100 Gitmo detainees are refusing meals and military officials there have ordered dozens to be force-fed, a brutal procedure involving a mask, plastic tubing, powerful drugs and restraints, as detailed in last month’s Al Jazeera report.
Metoclopramide, commonly known by its brand name Reglan, is supposed to speed up the digestive process and remove the urge to vomit during force feeding.
However, medical studies into the drug have determined that Reglan also is linked to a high rate of tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities.
The studies prompted the FDA in February 2009 to slap Reglan with a black box label – the agency’s strongest warning – to inform patients about the dangers associated with chronic use of the drug.
According to the FDA’s own medication guide, additional side effects include depression, thoughts about depression and, in extreme cases, suicidal thoughts and suicide.
Reglan works by blocking the neurotransmitter dopamine and the black box warning cites one study that reported a TD prevalence of 20 percent among patients treated for at least 12 weeks.
“Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD,” according to the black box warning on the package.
Hundreds of lawsuits have been filed against the drug’s manufacturers by law firms that have solicited patients who claim to have suffered irreversible side effects. The litigation is ongoing.
The revised Guantanamo hunger strike and force-feeding policy implemented in April recommends medical personnel administer Reglan to “enhance” the digestion of the liquid nutritional supplement Guantanamo prisoners are forced to take during tube feedings, according to the 30-page procedures manual obtained by Al Jazeera.
|Guantanamo talk: Closure promises rejected by detainees|
According to the manual, Reglan (along with other medications) may be given to prisoners during one phase of the force-feeding procedure to treat nausea and bloating after a tube is inserted into a prisoner’s nose and snaked down to his stomach. Another phase of the force-feeding procedure says 10 milligrams of the medication “may be useful when using intermittent feeds…to enhance gastric motility”.
Reglan can be administered orally, through disintegrating tablets, or by injection. The SOP does not advise the medical personnel administering force-feedings about the severe side effects associated with Reglan, nor does it state that its use should not exceed three months. Moreover, the SOP fails to state that Phenergan, another powerful drug recommended in the guidelines to treat nausea, is not to be given in combination with Reglan as it can heighten the risk of “Parkinson’s-like symptoms”.
With the hunger strike at Guantanamo now in its fourth month and more than a quarter of the protesting detainees being force-fed, the UK-based human rights organisation, Reprieve, fears Reglan has been administered to prisoners without their consent and beyond the recommended 12-week window when side effects become more apparent.
Human rights groups already have accused nurses and doctors of violating medical ethics by carrying out the prison’s force-feeding policy, which the United Nations has said rises to the level of torture; the American Medical Association (AMA) said in April it violates the medical profession’s “core ethical values”.
An article published Wednesday in the New England Journal of Medicine called Guantanamo a “medical ethics-free zone“.
“Force-feeding a competent person is not the practice of medicine; it is aggravated assault,” the authors of the journal article wrote.
|The force-feeding kit and restraint chair on display at the detainee hospital [Jason Leopold/Al Jazeera]|
The hunger strike SOP notes that medical personnel are not authorised to act independently of security personnel and are simply on hand to carry out the prison’s force-feeding policy.
Reprieve, which represents 17 Guantanamo prisoners, said the use of Reglan is another example of doctors failing to uphold their ethical duties to “do no harm”. Cori Crider, the strategic director of Reprieve, signed the letter accompanying the adverse incident report to the FDA on behalf of three prisoners being force fed at Gitmo.
Crider also sent a letter to ANI Pharmaceuticals, the manufacturer of the 10 mg tablets of Reglan asking the company to “assist us in stopping the misuse of your drug”.
According to materials she provided to Al Jazeera, Crider told API: “It is highly likely that prisoners are being medicated with Reglan without their informed consent. There is also a grave risk it is being administered for extended periods that may cause severe neurological side-effects…I am sure you will agree that the use of Reglan in the force-feeding of Guantanamo detainees is incompatible with your company’s aims.
“It places one of your products, intended to promote health, at the centre of a notorious and ongoing human rights violation, and will cause irreparable damage to your corporate reputation. The forcible administration of Reglan places you in potential breach of your duty as a manufacturer to warn of these adverse side effects, since any warning pamphlet is obviously made otiose in these circumstances.”
Neither the FDA nor a spokesman for ANI Pharmaceuticals returned calls for comment. Last month, Crider sent a letter to the chairman and chief executive of Abbott Laboratories, the manufacturers of the nutritional supplement Ensure, which has become symbolic with the force-feeding procedure at Guantanamo. The letter called on Abbott to “explicitly disassociate your product line from any use in force-feeding detainees at Guantanamo”. The company never responded to Reprieve, Crider said.
No cause for concern
Guantanamo officials, meanwhile, say concern over the use of Reglan is unwarranted.
“Heartburn and gastric reflux medications are only given to detainees who want or who feel they need them at the time of feeding,” said Lt Col Samuel House, a Guantanamo spokesman. “All medications provided to the detainees are the same FDA-approved medications available to treat US service members, with safeguards in place regarding dosage, drug interactions, dispensing and prescribing authority.
“No detainee has been provided 10 mg of Reglan on a regular basis for three months. I will need to check to see when the last time Reglan was used to treat a detainee.”
House said health care providers inform prisoners about the “dangers of medications”.
“In the end, it is up to the detainee,” he added. “Like all medications, the healthcare provider chooses the medication, based on symptoms and medical diagnosis.”
House did not provide a follow-up response as to when Reglan was last administered to a prisoner. Capt Robert Durand, the chief spokesman for the Guantanamo prison, told Al Jazeera on Wednesday there would be no further comment on Reglan or any other medications used at the prison.
|This force-feeding kit and liquid nutritional supplement was inside the media room at Camp 5 [Jason Leopold/Al Jazeera]|
“Prescriptions are provided with the consent of the detainee by licensed physicians who monitor for other drug interactions following warnings and label guidelines,” he said.
But during a recent visit to Guantanamo, Al Jazeera spoke with the medical officer in charge of the detention camp, a woman whose name we were not permitted to print for security reasons. When queried about the adverse side effects associated with Reglan, she said, “I’ve never heard of any issues associated with the use of that medication”.
“Reglan is just one option doctors use,” she said. “If there are any concerns I’m not familiar with what they are.”
The senior medical officer at the detention hospital, a physician whose name Al Jazeera was also not authorised to print, would not respond to direct questions about the use of Reglan. He said, “some [prisoners] complain of stomach distention and discomfort”, and they are receiving “first-rate medical care”.
Dr Joseph Jankovic, a neurologist at Baylor College of Medicine in Houston, told the Los Angeles Times in 2009 that Reglan “is prescribed by internists or gastroenterologists who are not necessarily familiar with the recognition of tardive dyskinesia”.
Jankovic told the Times he analysed 443 tardive dyskinesia patients at the Baylor clinic over the course of 25 years. He said that prior to 2000, the antipsychotic medication Haldol was responsible for the bulk of TD cases. However, Reglan was blamed for all TD cases since then.
“It is a public health problem,” Jankovic said. “Many of these patients who have metoclopramide-induced movement disorders aren’t recognised until…they’re at pretty advanced stages of the disease.”
Jankovic was unavailable to speak to Al Jazeera about the use of Reglan on hunger striking Guantanamo prisoners. Several other doctors Al Jazeera contacted said they were unable to provide an immediate opinion about Reglan’s use at the prison.
History of questionable use of drugs at Gitmo
This is not the first time the use of a controversial drug at Guantanamo has been called into question. In 2010, this reporter broke the story that all prisoners transferred to Guantanamo had been given treatment doses – 1,250 mg – of the powerful antimalarial, mefloquine, regardless of whether or not the prisoners had malaria. Mefloquine can cause severe neuropsychiatric side effects, including suicidal thoughts, hallucinations and anxiety.
There is no doubt that they would give me medicine without asking me.
An Army public health physician, Maj Remington Nevin, said in an interview at the time the use of mefloquine “in this manner…is, at best, an egregious malpractice” and was tantamount to “pharmacologic waterboarding”.
The government exposed prisoners “to unacceptably high risks of potentially severe neuropsychiatric side effects, including seizures, intense vertigo, hallucinations, paranoid delusions, aggression, panic, anxiety, severe insomnia, and thoughts of suicide”, Nevin said. “These side effects could be as severe as those intended through the application of ‘enhanced interrogation techniques.'”
Pentagon officials defended the practice and noted the drug was given to US military personnel as well. However, following a series of news reports linking the drug to suicides, a formal policy memo was issued in February 2009 by Army Surgeon General Eric Schoomaker, removing mefloquine as a “first-line” agent, and changed the policy so that mefloquine would not be prescribed to Army personnel unless they had contraindications to the preferred drug, the antibiotic doxycycline. Nor could mefloquine be prescribed to any personnel with a history of traumatic brain injury or mental illness. By September 2009, the policy was extended throughout the Department of Defense.
Last year, this reporter also co-authored an investigative story, citing a Defense Department watchdog’s report obtained through the Freedom of Information Act (FOIA), that showed Guantanamo prisoners were drugged against their will, “medically restrained” and interrogated while under the influence of powerful antipsychotic medications, such as Haldol, which also causes tardive dyskinesia.
No signs of side effects
Crider, of Reprieve, and other attorneys Al Jazeera spoke with said they have not seen any signs of the side effects associated with long-term use of Reglan in their Gitmo clients. Nor do they know if the prisoners were even given the drug. One of the problems Crider and other lawyers defending Guantanamo prisoners face is that they do not have access to the prisoners’ medical records, which would presumably document the drugs they have been given.
However, Crider provided Al Jazeera with notes from some of her hunger striking clients, all of whom said they have not been asked to provide consent prior to being administered medication.
“There is no doubt that they would give me medicine without asking me,” said Abu Wa’el Dhiab, a Syrian who has been cleared for release, during a phone call with the human rights group on May 30. “There is no doubt about that. I have experience in [hunger] strikes. They grind up the medicine and mix it with the food.”
Shaker Aamer, the last British prisoner at Guantanamo who has been cleared for release, said on May 5 in recounting the brutal force-feeding of another prisoner that medical personnel “gave him medicine without his consent”.
Samir Moqbel, who has been force-fed since March 17, said on April 8, “Everything is by force. None of this is administered by choice, for me or anyone else. Still they try to get us to take vitamins or other pills.”
Moqbel wrote a harrowing op-ed in the New York Times about the force-feeding process that attracted widespread attention to the brutality of the procedure.
Even if the prisoners were asked to consent, they are not in the right state of mind to understand what they are agreeing to, said Pardiss Kebriaei, an attorney with New York City-based Center for Constitutional Rights who just returned from meeting with several Guantanamo prisoners she represents. Kebriaei said conditions at the prison are “grave”. She said she could see the collar bone of one of her clients protruding from his shoulder.
“There is no way these men, after being on a hunger strike for more than four months, are in any shape to give consent,” Kebriaei said during an interview with Al Jazeera. “Even if [medical personnel] read the risks and side effects off the label [to the prisoners]. To think that they can give informed consent right now given the complete breakdown in communications at Guantanamo is ludicrous.”
Kebriaei added that some of her clients have been refusing to take medication altogether because of a lack of trust between the prisoners and medical staff.
Last month, 13 Guantanamo prisoners penned an open letter to military doctors at the prison facility, saying they “cannot trust your advice” and demanded they receive independent treatment by physicians hand-picked by their attorneys who are not associated with the military.
“I cannot trust your advice, because you are responsible to your superior military officers who require you to treat me by means unacceptable to me, and you put your duty to them above your duty to me as a doctor,” the prisoners wrote in a letter that Reprieve’s Crider helped coordinate. “Your dual loyalties make trusting you impossible.”
“Whether you continue in the military or return to civilian practice, you will have to live with what you have done and not done here at Guantanamo for the rest of your life,” they wrote. “You can make a difference. You can choose to stop actively contributing to the abusive conditions I am currently enduring.”
Pentagon spokesman Todd Breasseale dismissed the letter, saying there is “no precedent” for providing prisoners with independent doctors.