A Medicine that Differs Slightly from Another Can Have a Big Health Benefit

pills_money-jarFirst, there often are critical differences in clinical safety or effectiveness among drugs that act through similar mechanisms.

Second, even if two drugs are each effective in 40% of patients with a particular symptom or disease, each of them may not work in the same 40%.

Third, “supplemental,” or secondary, approvals of drugs — which include new dosages, formulations and uses — account for “a substantial share of drug utilization and associated economic and medical benefits,”

Fourth, in a study in the journal Nature Reviews Drug Discovery in 2011, Joseph DiMasi and Laura Faden of the Tufts Center for the Study of Drug Development persuasively debunked the myth that drug companies purposely produce duplicative me-too drugs. (WSJ)

Comments (20)

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  1. Yancey Ward says:

    Unless one has worked in the field, it is probably not understood just how finicky biological systems are in responding to drug interventions, even when the drugs have high similarity. My father suffers from very serious hypertension, and it took his doctor 2 years and multiple combinations of blood pressure medications, many of which are similar in function and structure, to just get a modest reduction in his blood pressure in which my father could tolerate the side effects.

  2. Mark says:

    “First, there often are critical differences in clinical safety or effectiveness among drugs that act through similar mechanisms.”

    So, different drugs have different side effects. Nothing new there.

  3. Wiliam says:

    “Second, even if two drugs are each effective in 40% of patients with a particular symptom or disease, each of them may not work in the same 40%.”

    We’re all so wonderfully different.

  4. Wally says:

    “It now takes 10-15 years for a pharmaceutical company to get a new drug approved, and on average the cost exceeds $1 billion.”

    Way to make things difficult

  5. Hal says:

    “These findings inform the discussion about the value of me-too drugs far more than the complaints of those who fail to appreciate the nuances of drug development and treatment.”

    Lets just remove all drugs from the market

  6. Devon Herrick says:

    …a study …persuasively debunked the myth that drug companies purposely produce duplicative me-too drugs.

    So called “Me Too” follow on drugs are often incremental advances to the drugs they mimic. They often help some people not helped by the original drug. Follow on drugs also create competition that lowers the price of the original.

    Moreover, the FDA set the bar for approval much lower for the initial drug in a class and much higher for a follow on drug in a given class.

  7. John R. Graham says:

    Plus, it is hard to imagine a policy that would prevent so-called “me too” drugs. If it takes 10-15 years to develop a new drug, that means drugs launched to day were started circa 2000.

    At what point was the FDA going to say: “Stop. We know which drug in this class is the best. The rest of you must all quit working now.”?

    I can’t imagine any investor would continue to put capital at risk in such an environment.

  8. Shreya says:

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