January 5th, 2009 by Dr. Val Jones in Audio, Uncategorized
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Amy Tenderich
Amy Tenderich is a leading online voice for diabetes advocacy. She is author of the popular blog, Diabetes Mine, and has type 1 diabetes herself. I caught up with Amy recently to discuss her concerns about a potential slowdown in diabetes research due to an increasingly risk-adverse FDA. You may listen to our conversation here, or read my summary below.
[Audio: http://blog.getbetterhealth.com/wp-content/uploads/2009/01/amytenderich.mp3]
Dr. Val: I understand that there’s a new petition asking the FDA to better serve the needs of people with diabetes. What is your role in that?
Tenderich: The petition represents the collective online voice of the diabetes community. It was spearheaded by Kelly Close, Manny Hernandez, and myself in response to what seems to be an increasing climate of extreme risk aversion on the part of the FDA. Patients generally don’t know much about the FDA’s actions, so we bloggers are stepping in to raise awareness.
Dr. Val: What do you think is making the FDA so risk-adverse?
Tenderich: As noted by Rebecca Killion, one of the few Patient Representatives who works directly with the FDA (and also has Type 1 diabetes), we’ve seen intensified regulatory issues in the post 9-11 era due to an increasing culture of fear. In addition, this country is so litigation happy, that everyone is trying to cover themselves. The media tends to dramatize things and they come out with headlines like “diabetes drugs will kill you.” In reality, certain drugs may be very helpful to millions of people, with caution only required for those in high risk groups. We need to counteract some of this fear and exaggeration by having patients speak up. We can’t just be yanking whole classes of drugs off the market because of a risk found in a small subgroup of potential users.
Dr. Val: Can you explain how the FDA’s new safety requirements might stymie diabetes research?
Tenderich: The FDA is adding additional cardiovascular research requirements to the development of all new oral diabetes drugs. This will have a chilling effect on innovations in diabetes care. As Rebecca has pointed out, it’s pretty unreasonable to require cardiac testing in phase II and phase III drugs that have not given us any reason to believe that they may pose a cardiac risk. The additional expense and time lag caused by testing the drugs for potential cardiac side effects will slow down the whole process and makes some research cost-prohibitive for smaller companies. It takes thousands of additional study subjects to rule out the possibility of cardiac harm, which can add up to tens of millions of dollars.
Patients put a lot of faith in the FDA and they just assume that it’s looking out for their best interest – both in terms of mitigating risks and also in regard to encouraging research in the right areas. However, the FDA can be very political – with individual researchers driving their own agendas, without specific regard to patient needs. The diabetes community would definitely like to see a stronger patient voice at the FDA.
Dr. Val: So in a perfect world, what changes are you hoping that the next FDA Commisioner will make?
Tenderich: We’d like to see the new Commisioner remove excessive research hurdles to pave the way for new drugs and innovations. Of course we want the FDA to keep safety in mind and issue warnings to appropriate at-risk populations, but we don’t want them to remove patient and physician choices. We’d like to see the FDA help (rather than hinder) the development of new technologies to improve quality of life, such as continuous glucose monitors. These devices can make a huge difference in diabetes management, but insurance companies are pushing back hard on coverage for them because of the high up-front costs for a long term gain.
The purpose of the petition is to implore the FDA to set up a Diabetes Advisory Council made up of patients, researchers, and physicians “in the trenches” and actively engaged in diabetes care on a day-to-day basis. That way the decisions made by the FDA will be more in tune with the needs of real patients.
To sign the petition, please go to www.healthefda.com.
For more information, please check out Amy’s blog post at Diabetes Mine.
January 4th, 2009 by Dr. Val Jones in Opinion
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I was a little surprised by a recent reader comment suggesting that pharmaceutical companies are no different than tobacco manufacturers. While I am strongly opposed to misleading pharmaceutical marketing tactics, the bottom line is that most drugs have a legitimate therapeutic value. Tobacco, on the other hand, is a known carcinogen with no medical value that I can think of. This comparison, however, brought into focus a common underlying assumption: that for-profit companies are inherently less ethical than non-profit and academic centers.
I’d like to question the tendency to absolve academic centers of any possible wrongdoing on the basis of their educational reputation or non-profit status. Of course, financial gain is not the only motivator behind endeavors, initiatives, and behaviors – though it may be the easiest to measure.
As a medical student I witnessed a sad example of academic misbehavior. Senior residents in the department of plastic surgery were performing liposuction procedures after hours for cash. When a patient experienced an infectious complication from a thigh liposuction procedure, an investigation ensued. The residents claimed to be putting the cash into the residency fund, to be used to support travel, lodging and participation in annual assemblies – therefore exonerating themselves of wrong-doing.
It is unclear if the department chair was fully aware of what the residents were up to, though he was reprimanded, terminated, and ended up teaching at another institution. The plastic surgery department lost its accreditation, and all of the residents had to finish their training elsewhere. As for me, I lost my mentor (the department chair) and ended up not pursuing a career in surgery. There certainly was a lot of fall out from that debacle on all sides.
A case of academic double standards was highlighted recently by Dr. George Lundberg in a Medscape editorial where journal editors claimed that continuing medical education (CME) courses should never be sponsored by for-profit companies. Meanwhile the journal accepted advertising from these same companies:
…The JAMA editors who wrote in 2008: “…providers of continuing medical education courses should not condone or tolerate for-profit companies…providing funding or sponsorship for medical education programs….” This is from a publication that, for more than 100 years, has been supported primarily by advertising revenue, mostly pharmaceutical. The editors will say “yes, but we follow rules to prevent bias or improper influence.” True. So do we, a for-profit company, follow rules that prevent bias and improper influence.
On the positive side, there are many examples of for-profit companies who cultivate a culture of environmental responsibility and charity – Ben & Jerry’s, SC Johnson, and Patagonia come to mind. And let’s not forget the foundations created by Bill and Melinda Gates, Warren Buffet and many others thanks to overflow from for-profit endeavors.
In the end, conflicts of interest, hidden agendas, and secret quid pro quos are a matter of individual character and corporate culture. The people who build a company (or a country) have more to do with its behaviors and processes than the simple label “for profit” or “non profit” or any assumptions made at such a superficial level.
We are all biased in many ways, both consciously and unconsciously. The best we can do is to strive for transparency. It may be best to judge each entity and/or individual by their degree of transparency rather than profit status, academic status, or subject matter expertise. For-profit companies can be highly ethical, and academic centers can be rife with undisclosed conflicts and questionable behaviors.
Healthcare organizations should not avoid or incur scrutiny based on their profit status alone. Bias comes in many forms – and the best we can do is work for the good of others in full knowledge of the influences around us.
January 4th, 2009 by Happy Hospitalist in Better Health Network, Health Policy, Opinion
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I just got notice from Blue Cross that they will be implementing a radiology management program for all advanced diagnostic imaging services starting in 2010. The costs of advanced diagnostic imaging (such as CT, MRI, cardiac nuclear medicine) are rising 10-20% per year.
Radiology management companies are an attempt by insurance companies to slow that growth curve. What does that mean if you are a doctor? Let me tell you how the program will operate. Blue Cross calls it their Radiology Quality Initiative or RQI, not to be confused with PQRI. Here are the details of their radiology benefit management initiative.
Q: What are the requirements? Read more »
*This blog post was originally published at The Happy Hospitalist Blog*
January 3rd, 2009 by Dr. Val Jones in Patient Interviews
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Thanks to KevinMD for highlighting an interesting discussion about the ethics of disclosing another physician’s error. It reminded me of a case I witnessed many years ago.
A young man had been in a car accident and was transferred to the rehab unit after several orthopedic surgeries and a long inpatient stay. Prior to beginning physical therapy, he was sent for doppler ultrasounds of his deep leg veins to make sure that he didn’t have a thrombus (clot) that might break off and lodge in his lungs during exercise. The ultrasound was actually positive for a large DVT. Unfortunately, the radiology note listed all the large veins that were patent (had no clots) first, and then finished with a notation of (+) DVT in one of the veins. The patient was transferred back upstairs to the rehab unit, the physical therapist glanced at the radiology report (where the first several sentences indicated normal findings) and took the patient to group therapy.
The patient got up out of his wheelchair, stood for a few seconds, and immediately collapsed. His DVT broke off and traveled to his lungs, causing a massive occlusion of his vessels. The crash cart arrived as he coded, the vascular surgery team quickly took him to the OR to crack his chest and try to remove the clot, but he didn’t make it. It was shocking and terrible.
What happened afterwards was memorable. The rehabilitation medicine attending notified the family of the error, explained exactly what happened and apologized with tears. The hospital administration was notified, the physical therapist, radiologist, residents, and attending physicians got together for a meeting in which a new reporting protocol for positive doppler findings was created. To my knowledge, there has not been another case of pulmonary embolism on that rehab unit since.
The family members did not sue. They were deeply grieved, but grateful for the transparency. The dangers of DVTs were indellibly burned into the minds of all physicians and staff working in the rehabilitation unit – and I believe that our lifelong vigilance may save many other patients from a similar fate.
That’s what should be done when mistakes happen.
