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.

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.

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.

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.

The event was attended by a wide range of healthcare stakeholders, including a government relations expert, FDA manager, US Marine, patient advocate, health IT specialist, transportation lobbyist, real estate lobbyist, health technology innovator, Kaiser-trained family physician, medical blogger, and EMR consultant. Here is what they thought was “right” with the healthcare system:

1.    Customer Service. Market forces drive competition for business, resulting in increased convenience and customized service. Healthcare consumerism has driven patient-centered innovations that improve quality of life. Examples include convenient walk-in clinics, online scheduling, services available in a one-stop location, and seamless transfer of health information (such as within the Kaiser Health system).

Memorable Quote: “We have a tremendous amount of choice in our system. That’s very good for patients and I hope we never lose it.”

2.    Accommodations For People With Disabilities. Kaiser Permanente was cited as an organization that takes special interest in facilitating good patient experiences for vulnerable populations and people with disabilities. For example, extra time is allotted for travel to and from the clinic, and schedules are built with flexibility to accommodate mobility impairments.

Memorable Quote: “Kaiser trains all its staff to be sensitive to people with ethnic, racial, and sexual preference differences. They learn to listen to the patient, and never assume they know what they think or feel.”

3.    Specialty Care. So long as a person has health insurance, access to the very best specialists in the world is available in a very democratic fashion to all patients. Several success stories included surgery and follow up for major multiple trauma, and congenital anomaly repair.

Memorable Quotes: “I’m only here today because of the technical skills of a U.S. surgeon who saved my life…” “I’ve traveled all over the world, and I wouldn’t want to get my medical care in any other country.”

4.    Social Media. Internet-based tools and social media platforms are leveling the communication “playing field” between providers and patients. People are discussing their care and treatment options with others like them online, as well as socializing with physicians and receiving real-time input on health questions.

Memorable Quote: “On Twitter I have I.V. access to physicians. I asked a health question and within 10 minutes I had 6 physicians answer me.”

5.    Access To Allied Health Professionals. Scheduling time with mid-level providers is easy, convenient, and effective. Patients enjoy the ability to access generalist care with nurse practitioners (for example) who provide quality care at a more relaxed pace.

Memorable Quote: “I love my nurse practitioner. She really listens to me and her schedule is much more flexible than physicians I’ve known.”

6.    Drug Development For Rare Diseases. The U.S. government offers grants, extended patents, and exclusivity to drug companies willing to develop drugs for rare diseases. This dramatically improves the quality of life for patients who would otherwise have no treatment options.

Memorable Quote: “The FDA recently approved the first drug for Pompe’s disease. Only a few hundred patients in the U.S. have the disease, and yet this life-saving medication was developed for them thanks to government incentives.”

7.    Patient Autonomy. The healthcare consumerism movement has replaced medical “paternalism” with care partnership. Patients are seen as consumers with choices and options who must take an active role in their health.

Memorable Quote: “Patient accountability is key to better health outcomes. But they need guidance and decision support… General health literacy is at a sixth grade level.”

8.    Health Education. Technology has improved health education dramatically. Patient education about their disease or condition is often facilitated by demonstration of computer-based anatomic models.

Memorable Quote: “I think that doctors are getting much better at communicating with patients in ways they can understand.”

9.    Coordination of Care. Some hospitals like the Mayo Clinic do an excellent job of coordinating care. For example, they provide each patient with photos and names of all the physicians, nurses, and specialists who are on their care team. Nurses update the patient’s schedule daily to reflect the tests and procedures anticipated and provide dignity and sense of orientation to the hospital experience.

Memorable Quote: “The Mayo Clinic has gone Facebook.”

10.    Democratization of Information & Transparency. Patients have the right to view and maintain all their medical records. They have many PHR options, and may be provided with CDs or thumb drives of their personal radiologic information to take with them to their next provider. Many doctors write their notes with the understanding that the patient will be reading them.

Memorable Quote: “One day soon, hospital stays will no longer occur in a black box. Family members and friends will be invited by the patient to view their daily schedule online, while nurses update planned procedures, events, and meetings. Family members won’t miss the opportunity to meet with the patient’s care team, because it will be on the schedule. MyChart (from EPIC) is working on making this hospital experience a reality at the Mayo Clinic soon.”

***

Thanks so much to all of you who attended. My husband will be preparing a report for the transition team shortly.

What do New Year’s Resolutions tell us about ourselves?  Will they cast light on our hopes for the coming years or embody regrets best left in the year past?  Resolutions tell us about our hopes, about who we want to be, and if made for the right reasons can lead us to the person we wish to be tomorrow.  A positive approach utilizing the support of family, friends, and caregivers will help us follow through with our resolutions and improve our chances for success.

For the last two years, resolutions to stop smoking, drinking, or overeating, have ranked only ninth on the New Year’s Resolutions list, while getting out of debt, losing weight, or developing a healthy habit are the top three.  If you find this surprising, you are in the company of many physicians. Yet this demonstrates the positive approach preferred by a majority making a New Year’s resolution. For each person making a resolution to stop or decrease a bad behavior, five choose to increase or start a good behavior, instead.  We can learn from this and maintain a positive focus when considering and following through on a resolution.  Keep in mind that only 40% find success on the first try and 17% of us need six tries to ultimately keep a resolution.

Avoid making hasty New Year’s resolutions based on absolute statements, which all too often meet with failure at the outset.  We recommend an approach based on The Stages-of-Change-Model, developed from studying successful ex-smokers.  For 30 years, primary care doctors have used this model to help their patients successfully rid themselves of a variety of bad habits.  The Model’s foundation is the understanding that real change comes from within an individual.

Below, I’ve outlined the five typical stages a person progresses through in changing a behavior, using the example of a smoker:

1.    Stage One/Pre-contemplative: This is before a smoker has thought about stopping.
2.    Stage Two/Contemplative: A smoker considers stopping smoking.
3.    Stage Three/Preparation: The smoker seeks help, buys nicotine gum, etc.
4.    Stage Four/Action: The smoker stops smoking.
5.    Stage Five/Maintenance and Relapse Prevention: Still not smoking, but if our smoker smokes again, keeps trying to stop, learning from mistakes.

The family and friends of a resolution maker are an intrinsic part of success and should avoid a negative approach. Instead, help them move through the stages, advancing when ready at their own pace.  The following exchange is typical of an office visit where a spouse’s frustration spills over, finding release:

“Dr. Simmons, Tell John to stop smoking!” John’s wife demands of me.

“Mr. Smith, you really should stop smoking,” I request of John.

“Well Doc, I don’t want to and that’s not why I’m here,” John says, pushing his Marlboros deeper into his shirt-pocket, clearly agitated with his wife and me.

“I’m sorry Mrs. Smith, John doesn’t want to stop, perhaps I could hit him over his head, knock some sense into him?”

Once negative energy has been interjected between me and my patient, I struggle to find an appropriate response.  Should I use humor to redirect?  I have rarely seen someone stop a bad habit after being berated.  I would prefer a chance to help him think about smoking and how it’s affecting his health.  Does he know that smoking is making his cough worse?  Has he been thinking about stopping lately?  Nagging seems to be more about our own frustration than a desire to help and should be avoided since the effect is usually the opposite intended.

A resolution can show the path to a happier and healthier life.  If you or someone close to you is planning to make a New Year’s resolution, just start slow, stay positive, have a strong support network….and one more thing: Resolve to stay Resolved.

In these challenging economic times, American companies are taking a cold, hard look at their P and L spreadsheets and nixing the least profitable parts of their businesses. The inevitable “non-profit” casualties present an ethical dilemma. What will become of the noble pursuits that are based upon “doing the right thing” rather than making a profit?

There is no such thing as completely unbiased publishing (humans all have personal agendas – whether conscious or unconscious), though The Medscape Journal came about as close to it as any medical journal ever has. The journal is free to authors and readers, and provides 24-hour online access to both professional and lay viewers from around the globe. There are no advertisements or outside sponsors, peer reviewers work without compensation or specific recognition, and editors are paid a minimal salary (full disclosure: I know this because I was an editor for The Medscape Journal several years ago). CME credit is offered for articles determined to be of special relevance, but no articles are commissioned specifically for the purpose of CME.

The Medscape Journal is a wonderful experiment in high ethics. It espouses, in my opinion, the gold standard principles of medical publishing. Tragically, market forces (or perhaps the lack of perceived value by its own parent company) killed it. So what does this mean for medical publishing? If there is no economic model for “pure science” then are medical journals doomed to go the way of health media – promoting sensational or biased science for profit?

The answer is no. But we must tread very carefully now. The Medscape Journal is our proverbial canary in a publishing coal mine. Its inability to survive on ethics alone speaks to a growing lack of value placed on purity over profitability. We must soberly consider the facts: 1) The Internet creates the illusion that information is “free” and therefore subscription-based publishing platforms will end as viewers simply refuse to pay. 2) Advertisers are becoming more aggressive in their requirements – dynamic microsites and multi-media advertorials have replaced the old billboard approach, often blurring the lines between content and advertisement. 3) Search engines like Google are changing the way that health messages reach the public and scientists alike. The “impact factor” of research often lies in its marketing campaign. Important negative trials are buried under case reports, anecdotes, and news stories with snappier headlines.

So what are scientists to do? I suggest that those of us committed to science-based medicine join together in a united effort to harness new media tools for the public’s benefit. Let’s use social networking applications (blogs, Twitter, Facebook, online communities, etc.) to educate others about science, research, health claims, and potential biases. Let’s not be afraid of marketing scientific integrity – decades have already shown us how effective marketing can be for snake oil. If we don’t raise our collective voices – how will people get good information on the Internet? How will Google searches return highly ranked, sound information rather than sensational headlines?

Farewell to The Medscape Journal – and thank you for nearly a decade of honorable medical publishing. May the rest of us continue the vision, if only on different platforms.

The “you may also like these posts” section is rather interesting below. How did it know I’d need stress buster tips?