Posts Tagged ‘physician’

A Patient’s Perspective on Day 2 of the FDA Public Hearing on Social Media

November 13th, 2009

Since I have great confidence in my fellow bloggers and all the fabulous Twitterati who followed today’s second day of the FDA Public Hearing on Social Media to provide detailed summaries of the day, I will take a different direction and offer my perspective as a patient on the hearing and the FDA’s  as well as pharmaceutical companies’ roles in social media.

I’ve been on branded prescription medication since I was 13 and first diagnosed with ulcerative colitis (inflammatory bowel disease), more for primary sclerosing cholangitis (autoimmune liver disease), more post-liver transplant, well you get the gist, so I have experienced my share of side effects and even a few adverse events and NOT ONCE did I think to make a report to the FDA.  NOT ONCE. Now I’m often chided for not being the average patient, but that further strengthens my argument here.  I’ve presented at NIH and not thought to report, I’ve worked with pharmaceutical companies and never thought to report, I’ve been a member of the Alliance to Strengthen FDA since it’s first year and never thought to report.

Why not? Well, my key concerns at the time were self-centered – what is going on? What is causing this? How can I make it stop?  For many of these answers I do turn to the Internet first, for context –is this normal? expected? will it resolve on its own? is there something simple I can do? —  but for resolution I ask my physician, because only in coordination with my doctor can I make the necessary adjustments or stop taking the medication. Reporting to FDA was not going to change my treatment.  It could have, in retrospect, changed treatment for others in even a more impactful way than sharing my experiences have changed treatment for fellow patients in social media and regular social environments.

Today’s hearing has impressed upon me how much we need a broadscale public relations campaign for FDA MedWatch or whatever new simplified reporting format takes its place.  (And yes, the federal appropriations, not user fees, to allow FDA to  do its many jobs.) Patient forums abound with people who not only want to help themselves, but help all patients standing with and coming behind them.  Social media and online reporting of patient experiences, good and bad, with medications can be a powerful force for improving healthcare by providing information for physicians, public health researchers, as well as regulators to access.

And Pharma – I am interested in the FDA-approved language and data (safety and efficacy)on the branded medications I take being easily accessible on the Internet and understandable.  I am not interested in pharmaceutical advertising, being approached by a pharmaceutical representative, or any overt contact of any kind.   I am happy to have them listen and correct grave misinformation if they believe that the particular forum is not sufficiently self-policing. Medication is not like shoes. I am happy to look at shoe advertising, talk to shoe people, and if the president of Zappos would like to come to my house, I’d bake him a cake.  I take medications because I need them and I’ve worked out a plan with my health care professionals of what, when, and why I will take them.  I welcome tools and information to boost my understanding, adherence, and coping, but I’d prefer if it came through a medical society or patient organization (even if pharma sponsored, I’d feel that it has been reviewed and tailored by people with interests more aligned with mine).

Bottom Line: I’m not as afraid of health social media because I believe in the intelligence, passion, persistence and generosity of my fellow patients (and I still believe in doctors). FDA has a strong role in ensuring that information by regulated entities (under their control or influence) is accurate and meaningful ( my preference over exhaustive) and that reporting mechanisms when there are negative interactions with that material or the products are well known, convenient, simple to fill out andsend.  Pharmaceutical companies and other regulated entities should listen more than talk and only interact to provide value to patients, as defined by patients.

Franken Bill Presupposes Doctors and Patients are Stupid

October 23rd, 2009

@PharmaGuy and I exchanged several tweets yesterday afternoon debating the merits of the Senate bill introduced by the junior Senator from Minnesota, Al Franken.  The title of the bill is the “Protecting Americans from Drug Marketing Act” the purpose of which is to deny the tax deduction for advertising and promotional expenses for prescription pharmaceuticals.

Reasons I’ve heard over the years why pharma direct to consumer advertising is bad:

  • Misleads patients into thinking that you can have intimate relations while soaking in separate bath tubs on the beach (sorry, that’s just my confusion)
  • Causes patients to spontaneously come up with symptoms and trick them into believing that there is something their doctors can do about them to make their lives better (no, still me)

You know you scoffed at restless leg syndrome until they found the gene

  • Ok, please leave some comments telling me why Americans are too stupid to risk being subjected to advertising on pharmaceutical products as opposed to any others and why physicians are too tired from explaining that antibiotics can’t cure a cold to resist writing a prescription for anything and everything a patient mentions during their 15 minute visit.  Here’s a start from Public Citizen http://www.citizen.org/publications/release.cfm?ID=7402

But the bill goes on to define advertising and promoting as “includ[ing] direct to consumer advertising in any media and any activity [emphasis mine] designed to promote the use of a prescription pharmaceutical directed to providers or others who may make decisions about the use of prescription pharmaceuticals (including the provision of product samples, free trials, and starter kits).”

So not only are patients not to be trusted, but physicians, nurse practitioners, pharmacists, and a host of healthcare professionals are also apparently unable to discern risks and benefits and decode pharmaceutical advertising and promotional activities.  Things that may arguably fall under this definition:

  • Sales rep and medical science liaison salaries (isn’t everything they do for the purpose of directly or indirectly promoting the use of the products – so longto those tens of thousands of jobs

(For that matter so long to all the positions in PR and advertising that support pharma — Obama didn’t REALLY want jobs created this year anyways)

  • Medication adherence programs (they promote the use of pharmaceutical products)
  • Patient Assistance hotlines and programs like TogetherRxAccess (ok, maybe you can still have them, you just can’t advertise and let patients know that they are there)
  • Patient or physician education programs raising awareness of a disease  (learning about diabetes may encourage people to actually take the treatments)

Now negation of the tax deduction is not the same as outlawing the practice, but it is close when you consider the pressure for profits from Wall Street and the realities of running a business. Please leave this type of regulation to FDA which has the expertise, if funds are properly appropriated, to craft reasonable remedies in the Risk Communication Committee and DDMAC.

What We Can Learn About Health Reform from GE’s Robert Galvin MD

September 30th, 2009

As members of Congress continue the arduous work of cobbling together healthcare reform legislation patients and consumers should hope that they are listening to the likes of Dr. Robert Galvin, Chief Medical Officer at General Electric.  I have to admit that after speaking with Dr. Galvin for some time last week about his career in clinical practice and his 15 years in the corporate setting researching, piloting, and sharing best practices in healthcare delivery and financing, I am now a huge fan. http://www.health.mil/dhb/members/20080812/Galvin_final_bio.pdf

I am a fan of:

Large employers, like GE, have served as a testing ground for many of the major elements of health reform.  Let’s use their lessons as a platform to accelerate meaningful changes in the healthcare system that  benefit us all.

A Patient’s Principles for Healthcare Reform

September 7th, 2009

If we truly wanted to create a patient-centric healthcare system – not insurer-centric, employer-centric, or even physician-centric – I believe that we need to do the following:
1. Redefine healthcare to include a holistic, 360 degree view of health from wellness, to prevention, diagnosis, treatment, rehabilitation, and hopefully back to wellness.
2. Align a payment system, not necessarily, but possibly an insurance system, to support those elements along this 360 degree paradigm that provide actual value, i.e. improve patient outcomes.
3. Provide transparency in pricing. Costs, potential cost-savings, and how those costs were calculated should all be included. Cost and price can be two different things. The government declaring that they need to cut physician payments in Medicare, for example, does not lower the costs of physicians delivering care.
4. Widely disseminate consumer education and patient decision support tools to facilitate informed evaluation of health and medical options.
5. Universal mandatory participation in some type of health insurance or financing mechanism coupled with guaranteed issue. The system should put individual coverage on an even playing field with employer coverage and drop barriers to multi-state or other groupings.
I believe in a system that is consumer-directed, where patients are able to accurately estimate the amount of financial risk they can tolerate for health expenses and can buy reasonably priced coverage for services above that personal level of risk. I believe that patients should have their choice of physicians and be supported and empowered to engage in appropriate self-management by members of their healthcare team. I believe that the most important decisions we make in healthcare involve what we eat, how much we move, choosing not to smoke, and other lifestyle choices, but when our genes, fate, or attempt to stay forever young fail us, the availability of quality medical care that does not bankrupt us in the best interest of all.

A Patient’s Perspective on Medication Compliance (Part 1)

September 7th, 2009

As the costs to the pharmaceutical industry and to the economy from patients not taking their medications as prescribed escalate into the billions and physician reimbursement is increasingly shifted to a “pay for performance” model where they are judged by outcomes as well as interventions, interest in understanding why patients do and do not comply with medication or other therapy recommendations increases.

Surveys of physicians consistently report a top complaint that patients refuse to take their medications as directed. Surveys of patients just as consistently state patients’ views that they are fully compliant with their medication therapeutic regimen. Somewhere in between lies the truth.

First, there’s the term compliance. Compliance, as defined by the Random House Unabridged Dictionary, is the act of conforming, acquiescing, or yielding. A person does not trade her free will for blind obedience when she trades her clothes for a paper gown. In this age of personalized medicine patients demand and deserve a personalized plan on taking that medication to which they are empowered and inspired to adhere.

Second, when a physician asks if a patient has taken her medicine that seems like a yes or no question. In fact, the patient is being asked, “Did you fill the prescription in a timely manner? Did you take the right dose at the right time in the right way every time (with food without food with a full glass of water on an empty stomach without lying back down for 30 minutes)? Did you take all the medicine (even after you felt better)? And did you refill the prescription as soon as you finished the first?” A patient may answer yes if they have fulfilled even one of these criteria.

What would drive a patient, even if diagnosed with diabetes, heart disease, or another serious, life-compromising condition, to not follow “doctor’s orders”?

  • Didn’t like being ordered around by the doctor
  • Medication tastes bad Side effects too much to bear
  • Method of administration painful or unpleasant
  • Taking the medication reminds the patient of her mortality
  • Doesn’t believe the condition is that serious
  • Treatment interferes with lifestyle
  • Forgot

(To be continued in Part II)