Cancer research in crisis: Are the drugs we count on based on bad science? – Salon.com

Quotes:

Cancer research in crisis: Are the drugs we count on based on bad science? – Salon.com

  • Only 6 out of 53 landmark cancer studies could be replicated, a dismal success ra te of 11%!
  • Reproducibility of research findings is the cornerstone of science.
  • Clinical studies, of new drugs, for example, are often plagued by the biological variability found in study participants. A group of patients in a trial may exhibit different responses to a new medication compared to patients enrolled in similar trials at different locations. In addition to genetic differences between patient po pulations, factors like differences in socioeconomic status, diet, access to healthcare, criteria used by referring physicians, standards of data analysis by researchers or the subjective nature of certain clinical outcomes – as well as many other uncharted variables – might all contribute to different results.
  • Two-thirds of the senior faculty respondents revealed they had been unable to replicate published findings,

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Anemia drug made billions, but at what cost? – The Washington Post

Quotes:

Anemia drug made billions, but at what cost? – The Washington Post

  • his blood readings had been close to normal, but Lenox trusted the doctors. After the nurse pumped the drug into his left shoulder, the former repairman for Washington Gas said he felt good enough to play basketball.

    The shots, which his cancer clinic had been billing at $2,500 a pop, were expensive.

    Hours later, Lenox was dead.

  • For years, a trio of anemia drugs known as Epogen, Procrit and Aranesp ranked among the best-selling prescription drugs in the United States,
  • The multibillion-dollar rise and fall of the anemia drugs illustrates how the economic incentives embedded in the U.S. health-care system can make it not only inefficient but also potentially deadly.
  • Both pharmaceutical companies conducted trials that missed the dangers and touted benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to rein in the largest doses, a high-powered lobbying effort occurred until Congress forced the regulators to let the drugs flow.
  • But at the center of any explanation of the popularity of these drugs are the nation’s doctors, clinics and hospitals, and the choices they made for patients.
  • Congress and Medicare bureaucrats forged a system in which doctors and hospitals would be reimbursed more for the drug than they were paying for it.
  • Coyne said he became a critic after the drug’s danger surfaced and the company continued to promote higher doses.
  • The drugs consisted of man-made versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells.
  • The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses
  • The key to their marketing was the claim that the drugs at higher doses could make patients feel better. By 1994, the drug’s label, approved by the FDA, advertised a range of benefits: “statistically significant improvements for . . . health, sex life, well-being, psychological effect, life satisfaction, and happiness.”

    Those claims, withdrawn 13 years later because they did not meet new FDA standards for proof, would be the basis of television and print advertising campaigns, pitched t o people with potentially fatal illnesses.

    The drugs, according to one, offered “Strength for Life.”

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