Dear God, I thought I was up on Obamacare, but this one had gotten by me.
Obamacare’s ludicrous Sunshine Act.
If you have – or know someone who has – a disease which doctors are still trying to figure out how to treat, forget about any new drugs or diagnostic tools anytime soon. This rule is the death of private research in medicine.
I’ve spent more than 30 years involved in medical research in both the clinical and industry settings. The way a new drug or device gets to market usually goes something like this. The new product is researched inside the company through the first stages of trials. A few industry leading docs are typically involved to provide guidance and even initial patient tests. The doctors and often patients are typically compensated for their involvement. There’s nothing wrong with this. The time and risk connected with a trial have a real value.
As confidence in gained in safety and efficacy, trials are broadened to larger groups of doctors and patients. Again, participation is typically compensated both for doctor and subject. For the patient, this compensation could include both monetary payment and extended care and testing of their condition. Clinical trials are incredibly time intensive for everyone involved; sponsor, investigator and patients. And since that is time that eaten up by the sponsor studying results, that the doctor could use seeing patients and time that the patient would otherwise by using for their job, it is also incredibly expensive.
A nickel and dime act is going to pile an unsustainable burden on research without bringing any real results.
There is already a very effective check of which most people are not aware. You see, most clinical research arrangements include rights to publish their research for the investigators. Often, the real reward is the fame and glory for being among the first to publish. Ethics requirements demand disclosing all relationships with the sponsors of the trials in those papers and abstracts. Falsification of credentials, relationships or results will be caught and that scientific malfeasance will end the researcher’s career. Again, industry sponsorship of these initial studies if not only acceptable but necessary due to the costs. In fact, without this sponsorship, these first studies will not occur.
However, a few industry-sponsored studies is not enough to gain acceptance for a new drug or device. All these studies do is alert the healthcare community of a potential new tool. Independent studies follow to corroborate or challenge the initial results. These studies may be funded by some combination of academic institutions, industry, professional societies and/or public or government organizations such as NIH. Again, it’s expensive and slow. It’s also necessary if you want to avoid patient harm and to gain clinical acceptance.
Yes. There are pens and knick-knacks and coffee cups and even bagels given away during these trials. So what?
Do you go to your bank because they give you a pen with their name one it? Anyone who thinks a doctor is going to throw away his or her career for a bagel is a damn fool.
Outside of the research community it is much the same. Of course the manufacturers spend money buying lunches or bagels for doctors, nurses and staff. These people are giving up their time in order to listen to the vendor and the time available – considering typical patient schedules – is almost always lunch time. These presentations are essential for getting information out about new drugs or devices. Once again, only the king of all idiots would think that a healthcare professional is going to flush their career down the toilet for a piece of chicken and some pasta or for a light-up pen.
Of course, there are exceptions to good ethical practice. Those are already dealt with by treaty, institutional policies and law. People who violate ethics for personal gain will have it catch up with them. At worst, their practice and reputation is ruined. More likely they end up the subject of lawsuits and/or criminal investigations. This law will do nothing to deter these violations. All it will do is impede research and the transfer of knowledge to the detriment of the public interest.
Then again, perhaps that is part of the goal. Where I noted earlier that research will dry up… well that’s only partially true. There will still be government funded research. Only now it will be disconnected from industry advancement. It will be driven by political interests and policies.
That should scare you. Scare. You. Badly. Look at the VA. If you want that as your standard of care, then welcome to Obamacare.