The Patient Centered Outcomes Research Institute (PCORI), formed under the ACA, named its first 25 awards for comparative effectiveness research this past December. The institute, funded by a $1 flat tax on health insurance consumers, along with additional federal funds, is non-governmental and non-profit. The 19-member board consists of patients, doctors, hospitals, drug makers, device manufactures, insurers, payers, governmental officials, and health experts, and is in charge of choosing comparative effectiveness research to fund. These research projects will compare different treatments for similar ailments to determine which is the most effective. A kind of research that has previously not been strongly funded, but has shown to have striking effects on our treatment plans.
Although many health insurers and individual payers are interested in the most “bang for their buck,” PCORI’s intent is not to help insurance companies or Medicare decide the treatment options to cover: the law specifically states that Medicare is not allowed to alter its coverage solely based on research funded by this institute. The intention of this institute is to increase the information available on the most effective care.
Many may remember hormone replacement therapy, once believed to reduce heart disease in older women; this treatment was given to a majority of women in the United States. Not until a comparative effectiveness trial was completed, was it realized the treatment actually increases heart disease in women and the practice was stopped almost immediately. Another comparative effectiveness study found that angioplasty, compared to bypass surgery, had a lower death rate on the operating table, but bypass surgery had a longer survival rate, if the surgery was successful. This outcome lead doctors to choose between the two options based on the individuals operating risk factors. Arthroscopic knee surgery was also once a common practice believed to reduce knee pain and discomfort for osteoarthritic patients. However, a comparative effectiveness trial found this treatment to have no noticeable reduction in pain, compared to no treatment at all, causing this practice to be reduced by half in eight years.
One might ask why some comparative effectiveness trials don’t cause a more drastic reduction in ineffective procedures, like arthroscopic knee surgery. The reason stems from longstanding beliefs and biases along with skepticism about studies. Many doctors and patients believe that doing something is better than nothing, and that newer technology must be better than older. Many are willing to undergo surgery in hopes of improvement, even if there is not strong data supporting its success. The same exists for pharmaceutical drugs. Many patients are eager to try new drugs for chronic illnesses, even if there is little data supporting their superiority to the current drugs which patients may not be satisfied with.
Also, pharmaceutical and medical device companies that find themselves on the wrong side of a revealing comparative effectiveness study are ready to spend millions in order to prevent doctors from hearing and believing the results of these studies, in fear of losing profits. These companies, unlike academics, have money to influence what studies doctors read and hear about. Academic studies are often regarded as less biased than studies funded by for-profit organizations; however, doctors are simply not exposed to them enough to be influenced by their results.
One criticism of PCORI is that all the board members have their biases as well, each coming from a different industry with a different agenda. Hopefully this will balance itself out, which was the intention of having a diverse board. However, many congressmen are skeptical about how fair the selection process is and whether the board will set a biased agenda influencing the outcome of the data.
In addition to choosing experts from a range of fields for the board, on March 26, PCORI approved 84 people to serve on the first four multi-stakeholder advisory panels, designed to advise PCORI and keep the work of the institute patient centered, according to PCORI’s news release. A few of the just recently funded projects look at oral vs. intravenous antibiotics, primary care for back pain, stroke rehabilitation, and different treatment methods for epilepsy, chest pain, and kidney failure. For now, the future looks bright and it is hard to argue against the formation of PCORI. The costs are minimal and the potential benefits are huge.