Untested drugs & off-label prescribing

“Do as I say and not as I do”  John Selden, Table-Talk c. 1654

Untested Drugs and off-label Prescribing

In his latest column for the Daily Telegraph (here), Dr Le Fanu says it is now forty years since he started practising medicine. Wondering whether or not things have improved, he notes medicine is certainly more expensive now.

He observes that almost all medical treatments in use today were already well established back then! While he couldn’t have anticipated sophisticated CT and MRI scans, keyhole surgery, medically, treatments are much the same:

…Open heart surgery, kidney transplants, hip replacements, cataract operations, the cure of childhood cancers and lymphomas, drugs for mental illness, gut and rheumatological disorders and so on.

untested drugs off label prescribing

Snake-oil salesman

Perhaps this explains the frustration of the doctors, scientists and academics who seek an excuse to prescribe off-label, “what can we responsibly offer to those patients for whom there are no suitable clinical trials?”

Imagine a homeopath seeking to prescribe on irrational grounds without “proof”, “evidence”, etc. We’d be hung out to dry and ridiculed for years to come. However, it is worth noting, as quoted below: “…The evidence base for medicine can come from many different sources.” Surely that includes homeopathic provings, the use of families and classification, toxicology studies and cured symptoms etc?

While a homeopath may be frustrated with the client before them, we always have our 3 principles of prescribing: the minimum dose, the medicine has to be a similimum and finally, each patient is treated as an individual. Otherwise, we don’t appeal to irrational and unscientific clutching at straws such as “off-label” prescribing. Off-label prescribing is the use of medicines outside the terms of their license.

Also below are some examples of questionable medical prescribing.

About 60 academics, scientists and doctors signed the letter below advocating off-label prescribing: click here

Passing the Saatchi Bill
SIR – We note the successful third reading of the proposed Medical Innovation Bill (the Saatchi Bill).

While there have been significant advances in cancer treatments in recent decades, there remain areas where there has been no meaningful advance. Diseases such as glioblastoma, sarcoma or pancreatic cancer have seen no clinically relevant improvements over those decades.

While clinicians have leeway to prescribe drugs “off-label”, we know from our direct experience with patients that viable clinical options are not being used in the vast majority of “terminal” cases. When all standard therapies have failed, and there are no clinical trials available, the response is almost uniformly to move that patient into palliative care.

We do not dispute that the clinical trial is necessary in order to identify those advances that work and those that do not. However, the evidence base for medicine can come from many different sources. Data collection is a necessary corollary of increased off-label usage and the new registry included in the Bill will record information (including side-effects and outcome data) in every instance of an innovative treatment. This ground-breaking registry will enable us to analyse real-world data, thereby providing greater patient protection than exists at present.

Ultimately the question that must be addressed is: what can we responsibly offer to those patients for whom there are no suitable clinical trials? (Emphasis mine)

Pan Pantziarka
The George Pantziarka TP53 Trust
Dominic Hill
Film maker & patient advocate
Professor Marc-Eric Halatsch
Professor of Neurosurgery, University of Ulm
Lydie Meheus
Managing Director, Anticancer Fund, Brussels, etc.

Cancer sufferers given untested drugs
Terminally-ill cancer patients are being used as human guinea pigs to test experimental drugs which may give them one last chance of beating the disease… (link)

Court rules that teenager can take untested CJD drug
An unnamed hospital trust in the province agreed last week to treat Jonathan Simms, 18, from Belfast, in the hope of prolonging his life. The hospital’s ethical committee agreed that he should have the drug pentosan polysulphate infused directly into his brain… (link)

Ebola: Liberians to receive experimental US drug
Around 40 percent of those infected with Ebola are surviving the current outbreak. But some called for the untested drug to be given to Africans… (link)

But that’s ok!…
Experimental Ebola drugs use in West Africa is ethical, says WHO
Untested medicines and vaccines should be used to treat Ebola patients, the World Health Organisation has said, as the drugs could be ‘potential asset’ it was argued… (link)

Unsound generic Aids vaccines have caused untold misery to millions
…And Britain must follow its lead. The WHO drive to treat 3m Africans by the end of next year is now sure to fail. WHO should accept defeat, acknowledge blame for its policy of approving untested drugs and apologise to the patients… (link)

Depressed children must be allowed medication says Glaxo
…In the US, Eli Lilly’s Prozac is approved for children, but some doctors still prescribe Paxil, even though it is not approved. This is known as “off-label” prescribing, and it is estimated that 8,000 child and teenage patients are prescribed the drug off-label every year… (link)

Eye patients to be given unlicensed drugs 
…trials and is licensed for the treatment of the condition in question. “However if a patient is willing to be prescribed a drug off-label, it is available on the clinician… (link)

GSK records $400m legal charge over US promotion
GSK is alleged to have promoted nine of its largest drugs for “off-label” uses. The company is co-operating fully with the investigation (link)

Regulator targets child medicines
…Most of these drugs are only approved for adults in Europe, although doctors sometimes use them “off-label” for young patients (link)

Drug companies accused of ‘conning’ the public
…Leading clinicians were recruited to try using the drug for conditions other than those for which it was approved, and to promote ”off-label” or unapproved uses, Prof Light maintained… (link)

Seroxat can be a danger to under 18s, doctors told
Although it is only licensed for adults, doctors prescribe it “off label” to about 8,000 children and teenagers suffering serious depression. Some patients have complained that it is addictive (link) (See also this website on Paxil/Seroxat)

Further Information
In Ireland the concern seems to be with marketing and with unlicensed herbal remedies. You could follow this link if it’s any help!!! (link)

“At the moment, patients prescribed an off-label licensed product are subject to poor monitoring and surveillance. The findings of this IPA study indicate a real need for better regulation of off-label prescribing. The IPA therefore calls for better regulation”.
Irish Patients Association website link

and their report: click here

In the UK, the GMC:
Prescribing guidance: Prescribing unlicensed medicines: click here

The Mayo Clinic – not Co. Mayo!
Mayo Clinic link

Flu Drugs are not tested and side-effects outweigh the benefits:
click here

Photo credit: Wikicommons link

Posted in Apologetics, Ethics, Medicines, Pharmaceutical Industry, Scientific Research and tagged , , , , , , , , , , , , , .