Posts Tagged ‘FDA’

Off-label Drugs and its potential use against cancer – An Intro by Raymond Chang MD

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The off-label use of a drug is the prescription or taking of a medicine for other than what it was originally intended for as described or approved by the US FDA or similar regulatory body. Simply put, medication usage for what is not on the official label of the drug is “Off-Label”.

Although hardly uncommon, there are distinct reasons why off-label prescribing is not as common as it ought to be if based on scientific evidence of efficacy alone. Firstly, it is unlawful to market, advertise or promote the off-label use of drugs (See an example of the intricacies and complexities as well as the conundrum of off-label regulation by FDA, US Congress and the Courts as evidenced by the recent saga of the Neurontin case in this 2004 paper by Robert Kaufman of the Harvard Law School).

Secondly, the insurance industry frequently invoke the off-label nature of a prescription to decline payment (ie they will not pay if they can find a reason not to pay, why would they? See illustrative story here), although Medicare in recently expanded its coverage of off-label treatments for cancer (See related news here), although it mainly applies to the use of an agent already approved for the coverage of some form of cancer to be covered when used for a different cancer, which is quite different from the drugs presented here ( approved for some other condition than cancer, to be applied for use as an anti-cancer), ie it is off-label use of a cancer drug rather than off-label use of a drug for cancer.

Finally, although the FDA does not regulate the individual physician’s prescription of a drug as long as it has been approved,  the legal liability for the physician is deemed higher especially if harm arises out of the course of its use and if it seems to deviate from “standards of care” which is how physicians are legally judged. Furthermore, physicians may be deemed to be engaged in human experimentation when prescribing drugs off-label (See a balanced discussion by Maxwell Mehlman JD on the legality and bioethics issues of off-label prescribing here)

It is because of potential legal risk on the part of the prescribing physician, limitations of insurance reimbursement, as well as the lack of knowledge about the potential off-label usefulness that limits the broader use of such drugs.  The unlawfulness of pharma related marketing or promotion and their lack of interest in investing in new clinical trials to demonstrate new indications when a drug has already gained FDA approval is often a factor limiting the broader use off-label treatments.

Back to the cancer patient: my purpose here is just to broaden the awareness of the science behind the usefulness of some very common and some not so common drugs that could jointly or otherwise enhance a patient chances of overcoming cancer, and to disentangle the healing process from insurance red-tapes and legal suffocation (See Disclaimer).

More useful info on Off-label Drugs for cancer can be found at the NCI site here.

TOPICS in this blog include:

Introduction to Off-label drugs for cancer

Posts (Publisjed, Most Recent or Recently Updated First)

  1. Statins, pleiotropic anti-cancer (6.10)
  2. Gamma-delta immunotherapy (2.09, updated 6.10)
  3. Urso as chemopreventative (5.09)
  4. Noscapine  near perfect (5.09)
  5. Naltrexone (2.09)
  6. Bisphosphonate (2.09)
  7. Clodronate for breast cancer (2.09)
  8. Gossypol (11.08)
  9. Metformin (10.08)
  10. Disulfirim (11.08)
  11. Dipyridamole (11.08)
  12. Cimetidine (11.08)

Draft Topics (To Be Published)

  • Cox-2 inhibitors (e.g. Celecoxib i.e. Celebrex)
  • PPAR agonists
  • Heparin
  • Anti-coagulants
  • Coumadin
  • Tetracyclines as Anti-angiogenics
  • Clarithromycin against lung cancer
  • Artesunate and Antimalarials for cancer
  • Lithium as immunomodulator
  • Anti-depressants against cancer
  • Cannabinoids
  • Benzodiazepines
  • Theophylline for B cell leukemia (CLL) / lymphoma (NHL)
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