By: Dr. Bharani Padmanabhan – Dec. 2016
Left to itself, the government naturally exerts greater and greater control over people’s lives and requires prior permission for everything.
In the case of medicine this literally costs lives.
We need government to ensure certain basic safeguards. Only government is big enough to push back against greedy pharma executives such as those that pushed to import Grünenthal’s Contergan (thalidomide) into the United States in the 1960s even as data came in from Europe and Australia about the catastrophe it caused.
However, government becomes a danger itself when it begins to micromanage what doctors have always done for their patients, and requires doctors to now seek the government’s approval for long-standing traditions.
Recently the State of New Jersey revoked the license of Dr Manoj Patharkar for prescribing a medicine off-label, meaning outside of the government’s official FDA indications.
The state trumpeted this news prominently.
This is a very dangerous development.
That Dr. Patharkar deserved to lose his license at age 45 is in no doubt, as he stole $3.6 million and cheated on his taxes as well.
But, it is chilling that the government highlighted revocation based on off-label use. Doctors have used medicines off-label for centuries as official FDA indications came in to use only well after WW2. In the timeline of medicine, FDA indications are the new kids on the block.
It is therefore outrageous that the government is happy to announce the revocation of a license based on off-label use.
Off-label is what the use of baclofen for spasticity in MS patients was for decades. Off-label is what the use of amantadine for fatigue in patients is. Off-label is what the use of sildenafil for erectile dysfunction was for years. Off-label is what the use of minoxidil for hair growth was for years. Off-label is what the use of diazepam rectally to stop bad seizures was for years. Off-label is what the use of Neurontin for diabetic neuropathy was for years.
Off-label use if how doctors learn what medicine works for their patients.
And off-label use is what leads to new immediately life-saving treatments such as the use of the anti-parasite drug nifurtimox for neuroblastoma, a type of brain cancer seen only in children.
Another anti-parasite drug used off-label, eflornithine, is now seen as a real cure for this childhood cancer – an anti-parasite drug to cure brain cancer. The government would never have officially come up with that by itself.
Read – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4729051/
This same medicine, eflornithine, is also used to remove unwanted facial hair. That indication was approved by the FDA so it is available for facial hair but a doctor’s license may be at risk now for curing childhood brain cancer.
If doctors had been under threat of license revocation a few years ago for using medicines off-label, this new cure for childhood brain cancer would never have been available to children and their parents right away as it is now.
The only people to benefit from the government revoking doctors’ licenses for using a medicine off-label are pharma executives whose control over the supply of medicines will become even tighter.
One can easily envisage pharma executives and their hedge fund supporters purchasing people in the government to scare doctors away from off-label use.
One can only hope Dr. Price, chosen to be President Trump’s Secretary for Health and Human Services, will put an end to this dangerous trend and keep the Statist swamp away from the daily practice of medicine.
Only doctors can and must determine what medicine they should use for their patients, regardless of what the government thinks.
Bharani Padmanabhan MD PhD is a neurologist who specializes in multiple sclerosis in the Boston area. email@example.com