Generic Medicine Quotes

That sentiment seemed absent, and shockingly so. In a conference call with a dozen company executives, Spreen expressed her fears about the quality of the AIDS medicine that Ranbaxy was supplying for Africa. One of the company’s top medical executives responded, “Who cares? It’s just blacks dying.

Food isn’t just generic energy—it’s molecular information. In addition to fueling the mitochondrial powerhouses, food tells our cells what to do and serves as building blocks for hormones, brain chemicals, and cell membranes.

Thakur’s findings were not news to Ranbaxy’s top executives. Just ten months earlier, in October 2003, outside auditors started investigating Ranbaxy facilities worldwide. In this case, the audits had been ordered up by Ranbaxy itself. This was a common industry practice: drug companies often hired consultants to audit their facilities as a dry run to see how visible their problems were. If the consultants could find it, they reasoned, then most likely regulators could too. The fact-finding mission by Lachman Consultant Services left Ranbaxy officials under no illusion as to the extent of the company’s failings. At Ranbaxy’s Princeton, New Jersey, facility, auditors found that the company’s Patient Safety Department barely functioned and training was essentially “non-existent.” The staff had no written protocols for investigating patient complaints, which piled up in boxes, uncategorized and unreported. They had no clerical help for basic tasks like mailing out the patients’ samples for testing. “I don’t think there’s the same medicine in this medicine,” was a common refrain from patients. Even when there were investigations, they were so perfunctory and half-hearted that expiration dates were listed as “unknown,” even when they could easily have been found from a product’s lot number. An audit of Ranbaxy’s main U.S. manufacturing plant, Ohm Laboratories in New Jersey, found that the company, though required to report adverse events to the FDA, rarely did so. There was no system to capture patient complaints after hours, and no global medical officer to ensure that any potential negative consequences for patients were being monitored. The consultants from Lachman urged Ranbaxy to address these problems globally. Ranbaxy’s initial reaction to the findings was to question the number of hours, and the resulting invoice, that Lachman had sent for its work.

At first glance, a militant conception of revolution seems more impractical than a nonviolent conception, but this is because it is realistic. People need to understand that capitalism, the state, white supremacy, imperialism, and patriarchy all constitute a war against the people of this planet. And revolution is an intensification of that war. We cannot liberate ourselves and create the worlds we want to live in if we think of fundamental social change as shining a light in the darkness, winning hearts and minds, speaking truth to power, bearing witness, capturing people’s attention, or any other passive parade. Millions of people die every year on this planet for no better reason than a lack of clean drinking water. Because the governments and corporations that have usurped control of the commons have not found a way to profit from those people’s lives, they let them die. Millions of people die every year because a few corporations and their allied governments do not want to allow the production of generic AIDS drugs and other medicine. Do you think the institutions and the elite individuals who hold the power of life or death over millions give a fuck about our protests? They have declared war on us, and we need to take it back to them. Not because we are angry (though we should be), not to get revenge, and not because we are acting impulsively, but because we have weighed the possibility of freedom against the certainty of shame from living under whatever form of domination we are faced with in our particular corner of the globe; because we realize that some people are already fighting, often alone, for their liberation, and that they have a right to and we should support them; and because we understand that the overlapping prisons that entomb our world have by now been so cleverly constructed that the only way to free ourselves is to fight and destroy these prisons and defeat the jailers by whatever means necessary.

the real benefit is that medicine will be transformed from reactive and generic to predictive and personalized.

We will continue to concentrate our energies entirely on prescription medicines and in vitro diagnostics, rather than diversify into other sectors like generics and biosimilars, over-the-counter medicines and medical devices.” ■ “With our in-house combination of pharmaceuticals and diagnostics, we are uniquely positioned to deliver personalized healthcare.” ■ “Our distinctiveness rests on four key elements: an exceptionally broad and deep understanding of molecular biology, the seamless integration of our pharmaceuticals and diagnostics capabilities, a diversity of approaches to maximise innovation, and a long-term orientation.” ■ “Our structure is built for innovation. Our autonomous research and development centres and alliances with over 200 external partners foster diversity and agility. Our global geographical scale and reach enables us to bring our diagnostics and medicines quickly to people who need them.

Thakur later returned home to find his three-year-old son, Ishan, playing on the front lawn. He suddenly recalled an incident from the previous year when the boy had developed a serious ear infection. The pediatrician prescribed Ranbaxy’s version of Amoxyclav, a powerful antibiotic. Despite his son’s taking it for three days, the boy’s 102-degree fever persisted. So the pediatrician changed the prescription to the brand-name antibiotic made by GlaxoSmithKline. Within a day, Ishan’s fever was gone. Thakur took the boy in his arms, resolving not to give his family any more Ranbaxy medicine until he knew the truth.

After the active ingredients are manufactured, the additional ingredients chosen, and the principal laboratory and clinical tests conducted, the formula then moves to the manufacturing floor to see if it can be made on a commercial scale. As the manufacturing runs become larger, the processes become harder to control. If something can go wrong, it will. You can build a fortress of current good manufacturing practices around the drug-making process and still “shit happens,” as Malik liked to say. Conscientious manufacturers try to protect against past disasters and prevent new ones. But because manufacturing plants are operated by humans, the systems will break down, no matter how perfectly designed they are. For example, Johnson & Johnson’s epilepsy drug was fine until the company stacked it on wooden pallets that likely leached solvents into the medicine. At Mylan’s Morgantown plant, one lab technician left a note for another stating that he had to “rig” a hose on the equipment to get it to work properly—a word choice that easily could have shut down the plant had an FDA investigator stumbled across it and suspected fraud instead of primitive problem-solving. The only remedy for this variability is for plants to adhere scrupulously to good manufacturing practices and create real-time records of each drug-making step. The resulting data serve as a blueprint for finding and fixing the inevitable errors, a process that FDA investigators scrutinize. How well and how closely did the company investigate itself? The goal is to address a problem “in a way that it never happens again,” as Malik explained.

On the one hand, this comports well with the classic justification of patent law as providing a spur to invention. On the other hand, it indicates how patent law may also distort a market, potentially obscuring less expensive generic alternatives that have the same therapeutic value.