Poisonous generic drugs

Mahatma Gandhi helped start the generic drug industry by urging his friend—a chemist—to copy Western drugs as a way to bring affordable medicine to India’s masses. Thus, the friend, Khwaja Abdul Hamied, reverse-engineered drug formulas and founded a company, Cipla, in 1935. The company prospered and, in the early 2000s, for example, provided HIV drugs to millions of people in Africa at a cost that was about 4 percent of Big Pharma’s price. Cipla is still a (mostly) trustworthy manufacturer of generic drugs, but many others are not. In fact, many manufacturers are producing drugs that are harming and sometimes killing patients. For example, in 2007 scores of kidney patients across the United States died from allergic reactions to the blood thinner, heparin. The heparin, which was manufactured in China, was contaminated.

In the US, imports from India make up 40 percent of all the generics we use; 80 percent of the active ingredients in both generic and brand-name medications come from India and China. In other words, they’ve merged with Big Pharma. I suppose this wouldn’t be so bad if the drugs were pure. But they’re not.

The FDA is supposed to regulate the industry by inspecting production and testing facilities and by exhaustively checking records. But inspection visits are rare and, until recently, the manufacturers are given plenty of notice before inspectors arrive, giving corporate officers time to destroy failed quality test results and fabricate documents that show successful tests. Some plants have even built fake production and testing areas that are kept pristine just for inspection purposes.

FDA inspectors avoid taking drugs made overseas. As a Ghanian creator of a drug verification program noted, “All medicines are poisonous. It’s only under the most controlled conditions that they do good.” Ack.

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Noise pollution

In 1949, buses in Washington DC installed a system to play radio programs (mostly music) in their buses and streetcars—conveyances owned by The Capital Transit System, a privately-owned public utility. At least two riders, Franklin Pollak and Guy Martin, were seriously annoyed by this turn of events—so annoyed, in fact, that the Public Utility Commission of the District of Columbia were forced to hold a number of hearings, in which they concluded that “the playing of radio programming was not inconsistent with public convenience, comfort and safety.”

Pollak and Martin appealed the decision, and the case ended up in the Supreme Court, which  concluded that the radio programs did not violate the First Amendment’s protection of Freedom of Speech (programs didn’t include objectionable propaganda) and also did not violate the Fifth Amendment (people in public transit were not guaranteed a right of privacy equivalent to that in a person's own home or vehicle). Justice Frankfurter chose not to participate in the case because he felt he couldn’t be objective: he believed himself to be a victim of music in the transit system. Justice Douglas dissented, arguing that playing music to a captive audience was contrary to the concept of liberty under the First Amendment and contrary to privacy under the Fifth Amendment.

You go justices Frankfurter and Douglas! I’m with you! Why must I be subjected to someone else’s choice of music everywhere I go? We can’t escape it. Where’s the liberty in that?

OK. It’s a pet peeve of mine. But noise pollution has serious effects on people: hearing impairment, tinnitus, hypertension, heart disease, changes in the immune system (most of these are stress related). Apparently, our sympathetic nervous systems are adversely affected by chronic noise. Someone has come up with the statistic that there are 10,000 deaths per year as a result of noise in the European Union.

Noise pollution is also a serious problem for animals. Example: researchers who were studying stress levels in whales, noticed that their stress levels dropped in mid-September 2001. The reason? A temporary pause in ocean shipping that followed 9/11.

Don’t even get me started on noisy restaurants.

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Hyperacusis: when sounds are painful

Every Fourth of July I conclude that I’m overly sensitive to loud noises. The parade in our small town always starts with fire engines, which I dread because of their sirens. The sound is painful to me and I cover my ears. (It bothers my half-deaf ear most.) I look around and nobody else is covering their ears. I recently learned of a condition called hyperacusis, but my problem is probably not that, unless it’s an extremely mild case. If I did have hyperacusis, the sound of running water might cause ear pain, as is the case of one sufferer.

Hyperacusis is a hearing disorder in which sounds are amplified in a painful way. Even the mildest environmental sounds can cause pain. I read about the case of a young man who was working in a noisy restaurant when his problem started. It got so bad he had to quit his job and move home with his parents. He describes the pain as “raw inflammation” and says that it includes pressure on his ears and temples and tension in the back of his head. He wears the kind of earmuffs people wear in shooting ranges. His family doorbell has been disconnected.

Information on Wikipedia lists notable people who have the condition. The majority are musicians. The most common cause is overexposure to loud noises. People can also get it as a result of diseases such as Lyme disease or from head injuries or from drugs. It is often accompanied by tinnitus—ringing or buzzing in the ear. Experts don’t know exactly why hyperacusis occurs. Theories include a malfunction of the ear’s protective hearing mechanisms, damage to a portion of the auditory nerve, a problem with the central processing system, or a malfunction of the facial nerve. It’s a rare disease but is increasing in occurrence.

I know that I wouldn’t be able to attend Jazzercise class without earplugs. I don’t see how people stand the loud music. I guess they’ve gotten used to it.

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Corporate medicine exploits doctors and nurses

Danielle Ofri, a physician at Bellevue Hospital and New York University writes that “corporate medicine has milked just about all the ‘efficiency’ it can out of the system. With mergers and streamlining it has pushed the productivity numbers about as far as they can go. But one resource that seems endless—and free—is the professional ethic of medical staff members.” What she’s saying is that most doctors and nurses are committed to doing the right thing for their patients and that the system takes advantage of them. Demands on them keep escalating “without a commensurate expansion of time and resources,” yet they continue uphold their professional ethics—sometimes at great personal cost—and try not to stint and caring for their patients. The nurse doesn’t take a lunch break; the doctor squeezes in the extra patients; evenings and weekends are dedicated to catching up with medical records, and so forth.

Here’s what’s happening:

• Primary care doctors spend nearly two hours entering information into the computer for every hour of direct patient care.
• Patients are sicker than in the past: more chronic conditions; more illnesses to treat; more medications to handle.
• Burnout levels among doctors are at new highs and increasing; doctors and nurses commit suicide at higher rates than in almost any profession.
• There are now roughly 10 administrators for every doctor. (From 1975 to 2010 the number of health care administrators increased 3,200 percent).

What are those administrators doing? I suppose a lot of them are entering the codes used by insurance companies. She doesn’t say, but they don’t sound like they do much good for the medical staff.

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.