The recent Dallas Buyer’s Club told the story of Ron Woodruff, a cowboy infected with the AIDS virus early in the epidemic. The story revolved around his inability to get access to drugs based on FDA safety requirements. Whenever a new drug, device or procedure is introduced, the question is asked- does this benefit the patient or is it a risk? Often it takes years of double blind randomized controlled studies to arrive at the answer. Occasionally the medical community doesn’t respond fast enough, but at least there is a process in place. The same can not be said for medical legislation and the tort system where there has been something of a free pass. Although both processes influence patient care, decisions are made by consensus rather than information.
Take HIPAA. Although designed to protect the patient’s privacy, there are adverse consequences that may actually hurt the patient by limiting access to critical medical records. Personally, I would prefer to opt out of HIPAA, or at least have certain records freely accessible, rather than risk the chance of a bad outcome.
Medical malpractice poses similar issues. Although the American tort system is designed to protect us, it actually ends up hurting more people than it helps. Tort brings a adversarial element to the doctor-patient relationship. In response some physicians change their practice patterns (CYA medicine) to defend themselves against the potential of a lawsuit. In many cases, additional tests and procedures with no reasonable benefit for the vast majority of patients are ordered. This promotes the opposite of what most double blind studies hope to achieve- exposing thousands of patients to risk for the benefit of the few. Although safe guards are needed to avoid substandard practitioners, other countries implemented safeguards with better results at far lower costs.
Our government often looks to intervene- to help & protect us from the adverse effects of care. However, indiscriminate use of regulation & process without a process of validation may lead to worse outcomes for the majority. If we are truly serious about a better healthcare system through outcomes and transparency, shouldn’t all aspects of care be evaluated? Legislation and legal process should not be given a free pass.