A preventive breast cancer vaccine developed by Professor Vincent Tuohy of the Cleveland Clinic will be brought forward to the FDA for permission to begin clinical trials to see if it is safe and effective for use in women.
The vaccine was shown to be completely safe and 100% effective in preventing breast cancer in three animal models, (see study in Nature Medicine), and was also found to slow the growth of tumors that had already formed. The vaccine is especially powerful in inhibiting the growth of triple-negative breast cancer, the most aggressive form of the disease with the lowest survival rate.
Triple-negative breast cancer lacks estrogen, progesterone and Her2 receptors. It occurs in approximately 15% of cases is the kind of breast cancer most common in women who carry a BRCA mutation.
The initial clinical trials, called Phase I studies, will be conducted in two groups of volunteers, women with triple-negative breast cancer who have completed their treatment and are free of disease, and women who will be vaccinated shortly before undergoing bilateral prophylactic mastectomy (typically these are women like Angelina Jolie with BRCA mutations who elect to remove their breasts to lower their risk for cancer.)
The first group of women will be studied to determine the dose and effectiveness of the vaccine; the second will be studied to make sure the vaccine does not trigger an untoward immune response in breast tissue.
The vaccine targets an unique protein normally made only by women who are breastfeeding, alpha lactalbumin (ALA). In the 12 years Tuohy spent developing and researching his vaccine, he discovered that the majority of breast tumors express, or make, ALA. Priming the immune system with a vaccine so that it attacks any cell that makes ALA is the method by which Tuohy’s vaccine works.
Because the vaccine targets ALA, a protein necessary for successful lactation in healthy women, the vaccine would not be appropriate for use in women who are still in their childbearing years.
However, the majority of women diagnosed with breast cancer in the United States and other western countries are post-menopausal: at least 60% of the cases in the United States occur in women over 55; thus, Tuohy’s vaccine holds great potential as a preventive vaccine for the majority of women.
With an unprecedented amount of attention and dollars spent on healthcare-related research at academic medical centers, institutions are often blazing their own trails with regard to innovation and commercialization. In an attempt to consolidate a diverse array of approaches, Cleveland Clinic Innovations and the Council for American Medical Innovation have joined forces to release the first-ever comprehensive study of technological innovation and commercialization at the nation’s top healthcare institutions.
The Medical Innovation Playbook will offer an in-depth characterization of how each of the top medical centers has organized to stimulate innovation and its commercial application. The Playbook will include profiles of at least 75 academic institutions and medical centers that, when combined, will result in an easy-to-understand guide that will be a resource for practitioners, academic executives, trustees, policy makers, companies, entrepreneurs and investors.
Cleveland Clinic is the health care industry trailblazer when it comes to publishing its clinical outcomes. As discussed in this earlier story (“How To Report Quality To The Public”), the Ohio hospital system annually publishes Outcomes Books that detail the clinical performance of each of its departments.
If you doubt this is radical, go to your local hospital’s Web site. See if it publishes how many patients died during heart surgery last year.
At Cleveland Clinic that number is easy to find. The hospital performed 459 bypass surgeries and only three patients died in the hospital. That is about a third the rate of deaths recorded at other hospitals for the same procedure.
Yet Cleveland Clinic does not only publish data that casts itself in a favorable light. In the third quarter of last year, 3% of bypass patients had strokes after their operations, when that number should have been around 1%.
I called the hospital’s corporate office to find out more about the history of the Outcomes books, how they affect hospital operations, and if there were lessons to share. I asked to speak to the de facto “Chief Transparency Office” and assumed I’d be directed to a middle manager working in the office of public affairs or marketing.
Instead, I soon found myself on the phone with the CEO. It turns out that Delos “Toby” Cosgrove, who runs the $6 billion health system, is also the organization’s unofficial transparency officer. He was the guy who developed the Outcomes Book concept in the first place.
Innovation has been a driving force behind health care from the beginning, yet with the U.S. health care system in the midst of an unprecedented transformation and a focus on lowering costs, many are asking, “What will become of innovation?”
The answer to that question is also a potential solution for hospitals facing financial pressures – a solution that has the power to improve patient care as well.
A growing number of hospitals are looking to develop a new revenue stream through the commercialization of medical innovations. They’re not doing it alone.
Just as Cleveland Clinic collaborates with other health systems on cardiovascular or cancer care, Cleveland Clinic Innovations has formed a national Innovation Alliance network to collaborate on the commercialization of medical innovations.
Cleveland Clinic Innovations, the corporate venturing arm of Cleveland Clinic, has a track record of converting and commercializing medical expertise, creating 55 spin-off companies and more than 300 licensed technologies that began as doctors and researchers’ ideas. Those companies have received nearly $700 million in equity investment.
This summer I spent some time exploring how big teaching hospitals publicly report clinical outcomes to the public. For a given set of patients, how many live or die? And with what complications?
Patients can rarely find this information before getting elective surgery, or when deciding to commit to a given institution for a long-term course of treatment.
The problem is that right now there are few short-term incentives for hospitals to be transparent to the public. Patients are used to finding care based on proximity, word-of-mouth, and referrals from trusted physicians. (None of these are bad methods, by the way.)
Meanwhile insurers and public programs rarely pay for better outcomes, so they do not build networks that steer patients to quality. Paternalism pervades the entire system, where insurers and providers alike do not trust patients to shop for the best care.
Thus it is only the most long-term focused institutions that decide to become radically transparent. And there’s one that stands out above the rest: Cleveland Clinic.
The Ohio institution is already known for excellent care, especially in cardiology, for being a “well-oiled machine”, and for being an economic bright spot in the otherwise dreary environs of Cuyahoga County. (Sorry, as Pittsburgher it’s hard for me to say nice things about the Mistake By The Lake.)
But something else Cleveland Clinic should be known for is its public outcomes reporting. Every year since at least 2005 Cleveland Clinic has published Outcomes Books on its Web site. For each clinical category it releases data on mortality, complication rates, and patient satisfaction. It also mails paper copies of these books to specialists around the country as a kind of transparency-marketing. No other hospital system comes close to reporting this level of detail about the quality of its care.
The many challenges in healthcare today require great leadership. Access, affordability and quality are just a few of the overarching issues that call for and, in fact, demand great leadership from within healthcare.
Traditionally, the criteria for a physician to advance to a leadership position have included academic and/or clinical accomplishments, rather than the distinctive competencies needed to lead. Furthermore, traditional physician training and the unique characteristics of physicians — we tend to value autonomy and, outside of structured interactions (such as the operating room or intensive care unit), may have poorly developed team reflexes — can handicap developing leadership skills.
Though developing great leaders and embracing change are well-established characteristics of frontrunner organizations in many industry sectors, healthcare organizations have generally lagged behind. What’s more, many healthcare organizations are structured in silos or “fiefdoms,” which represent a challenging environment in which to lead. Only recently are healthcare organizations awakening to the importance of developing physician-leaders and, in this context, offering physician-leadership programs.
There isn’t a country on this planet where there isn’t someone dreaming of curing cancer. What if there was something even more spectacular than curing cancer? What if you could stop cancer right in its tracks and eliminate its existence. Prevent it. Squash it before it starts.
Vincent Tuohy, PhD, an immunologist at Cleveland Clinic, may be on a path toward living this dream. This month at our hospital’s quarterly meeting, Tuohy was awarded Cleveland Clinic’s F. Mason Sones Award for 2010 Innovator of the Year for his recent breakthrough that may one day prevent breast cancer and perhaps revolutionize our approach to fighting all cancers.
Tuohy has spent the past eight years working to create a vaccine to prevent breast cancer. He and his team have found that vaccination with the protein α-lactalbumin prevents breast cancer in mice. His results were published in Nature Medicine, one of the most respected science journals, last summer.
The study yielded dramatic results. A group of mice that were at high risk to develop cancer according to their genetic profile was selected. Half of the mice were given the vaccine and half were not. All the ones given the vaccine did not develop breast cancer. All the ones not given the vaccine developed breast cancer. Yes, these are mice, and human trials are yet to begin. It may be ten years before we have a finished product, but such overwhelming results are promising and exciting.Continue reading…
I sat at home with a sense of relief. I had just finished my first month of residency – a grueling inpatient hospital month where I was pushed to new limits. I now finally had my first “golden weekend” (meaning I had both Saturday and Sunday off). More importantly, I had survived my first month without any patient deaths on my service. Given how sick people are when they come to the hospital, I felt pretty good about this result.
That feeling lasted less than 24 hours. As I logged in from home onto the electronic medical record to finish some documentation, I realized one of my patients was in coma due to a sudden stroke. This patient had few clinical symptoms and appeared the healthiest amongst all the patients I managed the entire month. A heavy knot quickly developed in my stomach, as I could not shed the feeling that perhaps I did something wrong. I scoured the medical records, retracing my management. Over the next couple of days I discussed the case with other colleagues and experts in the field, and read in depth on the management of this condition. To my relief it was clear that I did not nor did anyone involved in the patient’s care make an error in management. Unfortunately, however, this patient eventually passed away.
As I reflect on the experience, an important point stands out in my mind. This patient exhibited few signs of being “sick” and was managed very well by all the physicians during the course of the hospital stay, but died. On the other end of the spectrum are patients who appear incredibly sick, and despite a poor prognosis survive against odds. One of the goals of residency is to learn to assess a patient and quickly identify who is in imminent danger and may need immediate attention. Unfortunately, however, physicians cannot predict everything, as situations similar to the one above are not uncommon scenarios. Given this fact it makes the discussion about measuring healthcare and pay for performance very cloudy.