UNINTENDED CONSEQUENCES: How AIDS Began

“Out of Africa, there is always something new,” is how Jacques Pepin (the physician and researcher, not the chef) begins The Origin of AIDS. What follows the quotation from Pliny the Elder is a masterly 310-page assessment of molecular biology and social history—reconstructing how a simian immunodeficiency virus (SIVcpz) made the leap from chimpanzees to man in West Africa, changed its name to HIV-1, and ignited a worldwide epidemic that has killed 29 million people…so far.

Pepin hedges his thesis with admirable caution—he’s a scientist, not a polemicist—and academic reviews of the book aren’t in yet. That said, the volume marshals masses of data to suggest that SIVcpz has existed for centuries among some populations of Pan troglodytes troglodytes. This western chimpanzee subspecies that lives in Cameroon, Gabon, Equatorial Guinea, and the Republic of the Congo (a former French colony, distinct from the formerly Belgian Democratic Republic of the Congo to the southeast across the Congo River). In its history, SIVcpz has probably jumped several times into hunters or cooks who cut themselves while butchering or preparing bushmeat. Each time, this potentially fatal spark flickered out—until (probably in the early 1920s) the flame finally caught and grew. One or two—certainly fewer than ten—infected individuals passed the virus into the wider population.

Pepin traces a fascinating chain of changing medical and social factors in western central Africa that provided the tinder: Widespread injection programs (to treat or prevent sleeping sickness, leprosy, yaws, and syphilis, for example) likely expanded the infected population via unsterilized syringes. Then conscription for massive public works projects like the Congo-Ocean railway concentrated and mixed unmarried men from many regions while excluding women. The resultant rise in Western-style prostitution further spread the virus. By 1933, the French doctor Leon Pales was documenting cachexie du Mayombe, a wasting disease whose presentation is consistent with AIDS. (It is a sign of Pepin’s caution that he refuses to assert that it definitely was AIDS.)

At this point, though, the disease was still only smoldering. To fan the flames required the artificial colonial centers—the Belgians’ Leopoldville and the French Brazzaville, areas called centres extra-coutomiere, places beyond the reach of traditional customs—and the breakdown of traditional social structures, the rise of a cash economy, and the post-independence economic collapse to fan the flames.

The Origins of AIDS is not this year’s The Immortal Life of Henrietta Lacks, Rebecca Skloot’s best-selling family saga with heavy scientific spin. Pepin has written a review of the scientific literature with few individual voices…but a stunningly powerful story. Forced labor, economic exploitation, and prostitution all played parts in the evolution of the epidemic. But so did public health programs, infrastructure development, wider human rights, and independence. Pepin concludes with this new thing that he brought out of Africa: “Well-intentioned human interventions can have unpredictable and disastrous microbiologic consequences.” —Douglas McCormick

Smartphones Are Watching You Sleep, Eat, Breath, Etc.

Sleep Manager, a new app from Zeo, can measure how much time you spend in different sleep stages and let you know whether you’re getting the optimal amount of rest. The app syncs with a headband that measures the types of signals that would be recorded in a professional sleep lab (brainwave activity, muscle tone, eye movements) and then uses the information to actually alter the user’s sleep patterns, for instance waking them up during a light sleep stage instead of REM sleep. The app can also sync with other apps that measure fitness, such as RunKeeper and DailyBurn. Similarly, a team led by Ki Chon, professor and head of biochemical engineering at Worcester Polytechnic Institute, has developed an app that can accurately measure heart rate, heart rhythm, respiration rate and blood oxygen saturation using the phone’s built-in video camera. The app works by having users press their fingers against the camera’s lens and analyzing their pulse.

DUAL-NOVEL DRUGS ON THE RISE

Dual-novel combination drugs—combination drugs where neither of the component drugs has been approved for use by the FDA—are on the rise according to a recently published paper by consulting firm Oliver Wyman. Combination drugs are often used in oncology as they can attack the cancer from multiple points at once, but companies have been reticent to develop dual-novel combination in the past, for obvious reasons. However, since Janet Woodcock, the head of the FDA’s drug division, wrote an article in the New England Journal of Medicine this past spring supporting the development of dual-novel combinations, more companies are taking the chance, and there are currently around 25 in development. —Jeremiah Budin

FDA UPDATE

Apopharma received an NDA for Ferriprox (deferiprone), a new molecular entity that acts as an iron chelator to relieve patients suffering transfusional iron overload in treatments for thalassemia.

Edgemont Pharmaceuticals won FDA approval for its 60 mg tablet formulation of generic fluoxetine, labeled for major depressive disorder, obsessive compulsive disorder, bulimia nervosa, and panic disorder.

Boehringer Ingelheim received approval for a reformulation of Combivent Respimat oral inhalation spray, incorporating a new inhaler that delivers its combination of ipratroprium bromide and albuterol without propellant as a low-velocity mist, for patients with COPD who require a second bronchodilator.

The agency approved Merck’s Juvisync as a new statin/DPP-4 inhibitor for reducing heart attack, stroke, and certain lipidemias in patients with type 2 diabetes; the drug combines the glucose-lowering sitagliptin (the active component of Januvia) with Zocor’s simvastatin.

Lundbeck received an NDA for Onfi (clobazam) tablets for adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. The severe seizure disorder affects fewer than 200,000 people in the United States, qualifying Onfi for orphan drug designation. Catalent Pharma Solutions will manufacture the drug.

Innopharma won approval for the first generic olanzapine (the active ingredient in Zyprexa) to treat schizophrenia and bipolar disorder.

Recalls: Insight Pharmaceuticals (Langhorne, PA) recalled one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray. It may contain the bacteria Burkholderia cepacia. Superior Metabolic Technologies (Marietta, GA) voluntarily recalled the testosterone booster Uprizing 2.0, after tests showed that it appeared to contain the synthetic steroid superdrol, making it an unapproved new drug.

FDA and the Centers for Medicare and Medicaid Services (CMS) launched their previously announced “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage. The agencies began accepting submissions October 7, after issuing procedures to guide the process. The dual assessment is intended to speed up approval for innovative devices. —J.B.

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