A new report describing the bizarre and dangerous side effects of the sleep aid Ambien has once again raised questions about one of the United States’ most popular prescription drugs.
In a story by the Fix, Allison McCabe chronicled the numerous cases in which Ambien has caused individuals to commit unsafe, and sometimes deadly acts.
In 2009, 45-year-old Robert Stewart was convicted on eight charges of second-degree murder after he killed eight people in a nursing home. He was originally charged with first-degree murder, but by claiming his tirade was Ambien-induced he was able to have the charges lessened and sentenced to 142-179 years in prison.
In a similar case, Thomas Chester Page of South Carolina was sentenced on five counts of attempted murder despite his claims that Ambien was the cause of a shootout with officers. He received 30 years of prison on each count, to be served concurrently.
Although the Food and Drug Administration approved Ambien in 1992, its warning labels have changed significantly over the last two decades as evidence mounted documenting the drug’s ability to induce dangerous behavior.
“After taking AMBIEN, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing,” the label currently reads. “The next morning, you may not remember that you did anything during the night… Reported activities include: driving a car (“sleep-driving”), making and eating food, talking on the phone, having sex, sleep-walking.”
In the courtroom, cases related to Ambien use have ranged from shootings to child molestation charges to car accidents. In one such case, flight attendant Julie Ann Bronson from Texas ran over three people – including an 18-month old who suffered from brain damage as a result. When Bronson woke up in jail the next morning, she could barely comprehend what she had done.
“It was surreal. It was like a bad dream,” she said in May 2012. “I did the crime but I never intended to do it. I wouldn’t hurt a flea. And if I would have hit somebody, I would have stopped and helped. We’re trained in CPR.” Bronson pleaded guilty to the felony charges, but also received lesser charges by citing Ambien as the reason for her actions.
While some drug companies work on sleep aids that do not induce the kind of unpredictable and risky behavior Ambien does, the popularity of the medication raises concern over America’s prescription drug culture. The market for sleeping pills is a billion-dollar industry, yet dangerous side effects continue to be reported.
Last year, a report by the Department of Health and Human Services highlighted about 2,200 doctors for suspicious activities such as over-prescribing drugs. More than 700 Medicare doctors were also flagged for issuing what could be seen as “extreme” and potentially harmful prescriptions.
Although the report noted that some prescriptions could have been effective, it added, “prescribing high amounts on any of these measures may indicate that a physician is prescribing drugs which are not medically necessary or that he or she has an inappropriate incentive, such as a kickback, to order certain drugs.”
Soon after that report was issued, the Centers for Disease Control and Prevention found that roughly 18 women a day are dying in the United States due to prescription drug overdose, namely from painkillers like Vicodin and Oxycontin. With women making up 40 percent of all overdose deaths in 2010, these numbers marked a 400 percent increase compared to data from 1999.
The benefits of medication have also been placed under heavy scrutiny when it comes to other health issues, such as attention deficit hyperactivity disorder (ADHD). In December 2013, RT reported that the authors of the primary study promoting medication over behavioral therapy in order to treat ADHD now have serious concerns over their original results.
“I hope it didn’t do irreparable damage,” said one of the stud’s co-authors, Dr. Lilly Hechtman of Montreal’s McGill University. “The people who pay the price in the end is the kids. That’s the biggest tragedy in all of this.”
British MPs have voiced concern that doctors and researchers are being denied access to around half the results from all clinical trials. An influential parliamentary committee has condemned the selectiveness as damaging medicine as a whole.
This apparently standard practice of withholding critical medical test information impairs decision-making by professionals, worsens patients’ treatment and prevents independent assessment of medicines, the MPs wrote. And the practice, they say, dates back all the way to the 1980s.
In the report, the MPs write that they are “surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the United Kingdom. This problem has been noted for many years in the professional academic literature, with many promises given, but without adequate action being taken by government, industry or professional bodies.”
“This has ramifications for the whole of medicine. The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined,” said Richard Bacon, a senior member on the committee that published the report.
The MPs argue that this is a great problem also because the issue of access to clinical trials from previous years is absent from all new proposals. And test results on humans provide researchers with key evidence to support or oppose the use of a given medicine. There are unprecedented dangers when this framework is not operating as intended, they said.
Compounding the problem further, MPs say, is that aside from the non-publication of all clinical trial tests, for some reason positive results started popping up twice as much as negative ones. This is bad when all trial results on all uses of all chemicals should be provided, the report argues.
As a result, the committee’s MPs have given strong recommendations to the government and the country’s health bodies – among them, firstly, that the full results of clinical trials from now on be disseminated to all doctors and researchers in the UK, with full audits carried out regularly to check for transgressions; and secondly, that the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) ensure that all past and future trial results and the methods used to achieve them be published in a unified register for further use.
Bacon expressed alarm that the absence of past results invariably impact doctors’ decisions on treatment. “Regulators and the industry have made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today,” he said.
The worrying implication here is that so much medicine has been tested and approved over the past few decades, but only half of it we know the full truth about, it turns out.
One particular medicine that became a focus for alarm was Tamiflu – the popular flu medicine that gained popularity in 2009-10 during the great flu pandemic. Apparently, the UK Department of Health, without having access to exhaustive information on the medicine, had made a 424-million-pound decision to stockpile it between the years 2006-7 and 2012-13.
That kind of attitude, the MPs argue, is predicated on judgment, rather than real science. There is still no agreement on how the popular medicine works and disagreement on whether full information was provided to regulators by the MHRA during the licensing process. As it turns out from studies conducted by the non-profit NGO, Cochrane Collaboration, Tamiflu “did not reduce influenza-related lower respiratory tract complications.”
The organization is now in talks with Roche to receive the full details of Tamiflu’s testing, which will be included in a thorough upcoming review on its effectiveness. Both the government and the medical bodies will take part, as MPs share the think tank’s concern when it wrote that “we find it perplexing that the regulators continue to state that they had all the available evidence.”
Regarding Tamiflu and the wider practice as a whole, Bacon recommended that “before spending money in future to maintain the stockpile, the department needs to review what level of coverage is appropriate. It should look at the level of stockpiling in other countries, bearing in mind that the patent for the medicine runs out in 2016.”
Furious though it may be, the current debate over health care in the US is largely irrelevant to charting a path for poor countries of Africa, Latin America, Asia and the Pacific Islands. That is because the US squanders perhaps 10 to 20 times what is needed for a good, affordable medical system. The waste is far more than 30% overhead by private insurance companies. It includes an enormous amount of over-treatment, making the poor sicker by refusing them treatment, creation of illnesses, exposure to contagion through over-hospitalization, and disease-focused instead of prevention-focused research. 
Poor countries simply cannot afford such a health system. Well over 100 countries are looking to the example of Cuba, which has the same 78-year life expectancy of the US while spending 4% per person annually of what the US does. 
The most revolutionary idea of the Cuban system is doctors living in the neighborhoods they serve. A doctor-nurse team is part of the community and know their patients well because they live at (or near) the consultorio (doctors’ office) where they work. Consultorios are backed up by policlínicos which provide services during off-hours and offer a wide variety of specialists. Policlínicos coordinate community health delivery and link nationally designed health initiatives with their local implementation.
Cubans call their system medicina general integral (MGI, comprehensive general medicine). Its programs focus on preventing people from getting diseases rather than curing them after they are sick
This has made Cuba extremely effective in control of everyday health issues. Having doctors’ offices in every neighborhood has brought the Cuban infant mortality rate below that of the US and less than half that of US Blacks.  Cuba has a record unmatched in dealing with chronic and infectious diseases with amazingly limited resources. These include (with date eradicated): polio (1962), malaria (1967), neonatal tetanus (1972), diphtheria (1979), congenital rubella syndrome (1989), post-mumps meningitis (1989), measles (1993), rubella (1995), and TB meningitis (1997). 
The MGI integration of neighborhood doctors’ offices with area clinics and a national hospital system also means the country responds well to emergencies. It has the ability to evacuate entire cities during a hurricane largely because consultorio staff know everyone in their neighborhood and who to call for help getting disabled residents out of harms way. At the same time New York City (roughly the same population as Cuba) had 43,000 cases of AIDS, Cuba had 200 AIDS patients.  More recent emergencies such as outbreaks of dengue fever are quickly followed by national mobilizations. 
Perhaps the most amazing aspect of Cuban medicine is that, despite its being a poor country itself, Cuba has sent over 124,000 health care professionals to provide care to 154 countries.  In addition to providing preventive medicine Cuba sends response teams following emergencies (such as earthquakes and hurricanes) and has over 20,000 students from other countries studying to be doctors at its Latin American School of Medicine in Havana (ELAM, Escuela Latinoamericana de Medicina). 
In a recent Monthly Review article, I gave in-depth descriptions of ELAM students participating in Cuban medical efforts in Haiti, Ghana and Peru.  What follows are 10 generalizations from Cuba’s extensive experience in developing medical science and sharing its approach with poor countries throughout the world. The concepts form the basis of the New Global Medicine and summarize what many authors have observed in dozens of articles and books.
First, it is not necessary to focus on expensive technology as the initial approach to medical care. Cuban doctors use machines that are available, but they have an amazing ability to treat disaster victims with field surgery. They are very aware that most lives are saved through preventive medicine such as nutrition and hygiene and that traditional cultures have their own healing wisdom. This is in direct contrast to Western medicine, especially as is dominant in the US, which uses costly diagnostic and treatment techniques as the first approach and is contemptuous of natural and alternative approaches.
Second, doctors must be part of the communities where they are working. This could mean living in the same neighborhood as a Peruvian consultorio. It could mean living in a Venezuelan community that is much more violent than a Cuban one. Or it could mean living in emergency tents adjacent to where victims are housed as Cuban medical brigades did after the 2010 earthquake in Haiti. Or staying in a village guesthouse in Ghana. Cuban-trained doctors know their patients by knowing their patients’ communities. This differs sharply from US doctors, who receive zero training on how to assess homes of their patients.
Third, the MGI model outlines relationships between people that go beyond a set of facts. Instead of memorizing mountains of information unlikely to be used in community health, which US students must do to pass medical board exams, Cuban students learn what is necessary to relate to people in consultorios, polyclínicos, field hospitals and remote villages. Far from being nuisance courses, studies in how people are bio-psycho-social beings are critical for the everyday practice of Cuban medicine.
Fourth, the MGI model is not static but is evolving and unique for each community. Western medicine searches for the correct pill for a given disease. In its rigid approach, a major reason for research is to discover a new pill after “side effects” of the first pill surface. Since traditional medicine is based on the culture where it has existed for centuries, the MGI model avoids the futility of seeking to impose a Western mindset on other societies.
Fifth, it is necessary to adapt medical aid to the political climate of the host country. This means using whatever resources the host government is able and willing to offer and living with restrictions. Those hosting a Cuban medical brigade may be friendly as in Venezuela and Ghana, hostile as is the Brazilian Medical Association, become increasingly hostile as occurred after the 2009 coup in Honduras, or change from hostile to friendly as occurred in Peru with the 2011 election of Ollanta Humala. This is quite different from US medical aide which, like its food aide, is part of an overall effort to dominate the receiving country and push it into adopting a Western model.
Sixth, the MGI model creates the basis for dramatic health effects. Preventive community health training, a desire to understand traditional healers, the ability to respond quickly to emergencies, and an appreciation of political limitations give Cuban medical teams astounding success. During the first 18 months of Cuba’s work in Honduras following Hurricane Mitch, infant mortality dropped from 80.3 to 30.9 per 1000 live births. When Cuban health professionals intervened in Gambia, malaria decreased from 600,000 cases in 2002 to 200,000 two years later. And Cuban/Venezuelan collaboration resulted in 1.5 million vision corrections by 2009. Kirk and Erisman conclude that “almost 2 million people throughout the world … owe their very lives to the availability of Cuban medical services.” 
Seventh, the New Global Medicine can become reality only if medical staff put healing above personal wealth. In Cuba, being a doctor, nurse or support staff and going on a mission to another country is one of the most fulfilling activities a person can do. The program continues to find an increasing number of volunteers despite the low salaries that Cuban health professionals earn. There is definitely a minority of US doctors who focus their practice in low income communities which have the greatest need. But there is no political leadership which makes a concerted effort to get physicians to do anything other than follow the money.
Eighth, dedication to the New Global Medicine is now being transferred to the next generation. When students at Cuban schools learn to be doctors, dentists or nurses their instructors tell them of their own participation in health brigades in Angola, Peru, Haiti, Honduras and dozens of other countries. Venezuela has already developed its own approach of MIC (medicina integral communitaria, comprehensive community medicine) which builds upon but is distinct from Cuban MGI.  Many ELAM students who work in Ghana as the Yaa Asantewaa Brigade are from the US. They learn approaches of traditional healers so they can compliment Ghanaian techniques with Cuban medical knowledge.
Ninth, the Cuban model is remaking medicine across the globe. Though best-known for its successes in Latin America, Africa and the Caribbean, Cuba has also provided assistance in Asia and the Pacific Islands. Cuba provided relief to the Ukraine after the 1986 Chernobyl meltdown, Sri Lanka following the 2004 tsunami, and Pakistan after its 2005 earthquake. Many of the countries hosting Cuban medical brigades are eager for them to help redesign their own health care systems. Rather than attempting to make expensive Western techniques available to everyone, the Cuban MGI model helps re-conceptualize how healing systems can meet the needs of a country’s poor.
Tenth, the new global medicine is a microcosm of how a few thousand revolutionaries can change the world. They do not need vast riches, expensive technology, or a massive increase in personal possessions to improve the quality of people’s lives. If dedicated to helping people while learning from those they help, they can prefigure a new world by carefully utilizing the resources in front of them. [...]
Discussions of global health in the West typically bemoan the indisputable fact that poor countries still suffer from chronic and infectious diseases that rich countries have controlled for decades. International health organizations wring their hands over the high infant mortality rates and lack of resources to cope with natural disasters in much of the world. 
But they ignore the one health system that actually functions in a poor country, providing health care to all of its citizens as well as millions of others around the world. The conspiracy of silence surrounding the resounding success of Cuba’s health system proves the absolute unconcern by those who piously claim to be the most concerned.
How should progressives respond to this feigned ignorance of a meaningful solution to global health problems? A rational response must begin with spreading the word of Cuba’s New Global Medicine through every source of alternative media available. The message needs to be: Good health care is not more expensive — revolutionary medicine is far more cost effective than corporate controlled medicine.
1. Fitz, D. (December 9, 2010). Eight reasons US healthcare costs 96% more
than Cuba’s—With the same results.
2. Dresang, L.T., Brebick, L., Murray, D., Shallue, A. & Sullivan-Vedder, L. (July-August, 2005). Family medicine in Cuba: Community-Oriented Primary Care and Complementary and Alternative Medicine, Journal of the American Board of Family Medicine 18 no. 4: 297-303.
3. Cooper, R.S., Kennelly, J.F. & Orduñez-Garcia, P. (2006). Health in Cuba, International Journal of Epidemiology, 35: 817–824.
4. Pérez, J. (May 15, 2012). Gender and HIV Prevention. Slide presentation at the Pedro Kouri Institute of Topical Medicine, Havana, Cuba.
5. Whiteford, L.M. & Branch, L.G. (2008). Primary Health Care in Cuba: The Other Revolution. Lanham: Rowman & Littlefield Publishers, Inc.
6. Fitz, D. (February 14, 2012). Med School Classes Cancelled in Havana.
7. Kirk, J.M. & Erisman, M.H. (2009). Cuban Medical Internationalism: Origins, Evolution and Goals. New York: Palgrave Macmillan.
8. Fitz, D. (March, 2011). The Latin American School of Medicine Today: ELAM. Monthly Review 62 no. 10: 50–62.
9. Fitz, D. (September, 2012). Cuba: The New Global Medicine. Monthly Review 64 no. 4: 37–46.
10. Brouwer, S. (2011). Revolutionary Doctors: How Venezuela and Cuba are Changing the World’s Conceptualization of Health Care. New York, Monthly Review Press.
Don Fitz can be contacted via firstname.lastname@example.org
- 80 percent of Cuban AIDS patients since 1986 alive (vancouverdesi.com)