Undisclosed conflict of interest in the FDA review process

A report from the WSJ this week detailed the fact that FDA reviewers had significant and undisclosed financial ties to industry. I found this discovery remarkable, especially the undisclosed part.

But perhaps more remarkable was the lack of reaction it created. The article has only 39 comments, paltry numbers of Tweets and FB shares and little buzz on social media. That seems weird. These are FDA reviewers. The FDA follows their advice in the majority of cases. These people have great influence; millions of patients depend on them.

The WSJ article said, “a third of 122 members had received compensation—such as money, research grants or travel and food—from medical-device companies.” But the FDA “disclosed roughly 1% of these corporate connections.”

There is a lot of talk these days about conflicts of interest in healthcare. In clinical medicine, pens with logos have been banned, and gifts of bagels and burritos must be disclosed. At medical meetings and in scientific journals, industry ties must be displayed prominently. In September of this year, the first release of data from the Sunshine Act showed doctors and hospitals received $3.5 billion from drug firms. It isn’t easy but you can find my conflicts.

The aim of these efforts is transparency. Gifts, however small, have an effect. I can, for instance, look at a patient’s medicine list and tell whether her doctor has been influenced by marketing and hype. The presence of brand-name drugs is the give away. But these are just single doctors taking care of single patients.

Think of the influence at the level of the FDA review committees.

One recent example comes to mind. It’s in Europe, but it also could happen here. The procedure called renal denervation, which is ablation (burning) of nerves in the kidney, was supposed to control high blood pressure. Early data showed it had striking effects. But the early data came from poorly controlled studies with small numbers of patients, among other problems. It was flawed data.

Yet the European equivalent of the FDA sanctioned the device and the procedure. Thousands of patients underwent the invasive procedure across Europe. Then, this spring, a large well-controlled, multi-national trial found that the procedure did not work. The reversal was a shocker to the medical community. Most of the discussion centered on the science itself. There was little talk about the thousands of patients who underwent unnecessary kidney burns.

I am not suggesting the European agency made this mistake because of industry influence, but you could see how it is possible. If pens with logos can influence a practicing doctor, surely big dollars can influence reviewers.

Dr. David Kandzari is a well-known leader in cardiology. He is involved with clinical research, and as such, has industry relationships. He also serves as an FDA reviewer. Here is his quote in the WSJ piece:

“I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way.”

How do you interpret this statement? To me, it sounds akin to the doctor who says pens and burritos don’t affect him. Maybe they don’t, but why else would there be pens with logos and free burritos?

I exchanged emails with a respected colleague about this issue. He doesn’t see much bias in the FDA review process. He made the point, a good one, that it’s hard to find qualified experts who haven’t had collaboration with industry. Then he sent me a huge file of one recent transcript of an FDA review. “Look at the transcript here and see if you can see any bias,” he said.

And that is the point, isn’t it?

You can’t see bias. It’s invisible; it’s in our human consciousness.

It seems reasonable, therefore, that if bias can’t be seen or eliminated, the potential conflicts that lead to bias (e.g. dollars) should be disclosed.

JMM

11 comments

  1. Good on ya Dr. John.

    The practice of medicine, like every other aspect of our corporate-controlled daily lives, has become fundamentally dishonest, greedy.and exploitative.

    I’m sick of getting 7 minutes with as electrophysiologist, who distractedly hands me a flecainide pill in the pocket prescription, despite my very low BP and HR, and then laughs at me a few weeks later when I come through the emergency room with wild atrial flutter. He flippantly remarks that “nobody ever dies of atrial fibrillation or flutter” and that since my low HR and BP make rhythm/rate control problematic he will be happy to zap my AV node so I can have a nice expensive pacemaker to depend on for life support the rest of my days.

    I self-deprescribed afib meds, started taking magnesium, potassium, taurine and GABA, along with other supplements I was already taking, gave up MSG, alcohol, aspartame and caffeine, walk 3-4 miles per day, and have reduced my bouts of afib to almost zero over six months. I take no other meds except a daily kid dose aspirin.

    I started exploring integrative, holistic medicine.

    And there one finds a counter movement evolving quickly of doctors and patients who have become completely fed up with the mindless churning of patients through the soulless & scary corporate medical system.

    I am searching for a integrative medical doc with decent credentials who (hopefully) accepts my insurance, but they are hard to find in my part of the country. I will keep looking, as every day there are more docs migrating away from their frustrating medical practices.

    In the meantime, I am avoiding going back to my former big hospital medical corporation staffed with doctors and cardiologists who march in lockstep to the drumbeat of corporate money grubbing, and who make it perfectly clear during your 7 minutes with them that your individual fate and welfare are mostly subordinated to the profit motive.

    1. How can a low heart rate make rate control problematic? – sounds more like you don’t need any drug. Is your electro trying to make you believe that brief periods of high rate when you have an episode are a catastrophe even though “nobody ever dies of it”? For most people, they’ll be nowhere near as damaging as a pacemaker. You plainly don’t have to be told this, but anyone getting the AV-node ablation push should start by doing a PubMed search for “pacemaker” and “tricuspid regurgitation”.

      1. HR went to 40 in the hospital as a result of beta blocker & Rythmol–given for atrial flutter, which I believe was caused by flecainide, as I’d never had it before beginning flecainide.

  2. Short answer: More people would be upset if they understood the issue.

    Longer musings: Humans, particularly those of us who take pride in our brain power, enjoy thinking that we are above marketing influences. An enormous body of scientific evidence suggests otherwise, but still the delusion persists. Ironically, those who think they are immune make the best targets. Marketing professionals have understood this for decades, and going toe to toe with them when you don’t understand what they’re doing is like showing up to a CX race with a beach cruiser.

    One simple example: Some might wonder why drug companies are so eager to get early positive headlines from small studies that don’t hold up to later scrutiny. We wonder, why overstate your claim when you could make a much stronger case with a little more time? Understand ‘Anchoring Bias’ and it all makes sense.

    One field that has embraced the idea that it’s remarkably easy to fool yourself (and not even realize it) is finance. When you’re making million+ investment decisions, fooling yourself costs real money. One thing that makes finance different from other fields is that you get eventual feedback when you make a cognitive mistake, and it’s painful. In most areas of life, cognitive mistakes go unrecognized and even make us feel better.

    It’s no wonder that Kahneman was popular early in finance circles.

    You’re on to something when you talk about re-framing the way we look at bias. Bias isn’t a 4 letter word; bias is a part of being human.

    No one would ever seriously say “I don’t make mistakes.” We should consider the claim “I’m not biased” to be equally ridiculous.

    1. I don’t know why everyone is so surprised by this COI. It has been with the FDA since its inception, as well as the USDA. It is the way the community works. Knowing this fact in advance should provide you with sufficient skepticism to keep yourself safe from the malevolence of bias. Clearly, lifestyle changes are what work the best.

  3. Read the below. As an afib patient, I think WE should be getting the free pens, bagels, and burritos. My doctor never once offered me any of that stuff he got. Maybe if I agree to an ablation, he’ll offer me the pen I use at the office to fill out the check… I can’t eat bagels and burritos. Only doctors can eat them without “causing” their afib. Anyway, read this:

    “According to research published recently in Circulation: Cardiovascular Quality and Outcomes, patients with atrial fibrillation add $26 billion to the U.S.’s health care costs annually.

    Of that $26 billion total, $6 billion goes to AF care, $9.9 billion winds up being spent on other cardiovascular risk factors or disease and $10.1 billion is spent on treating non-cardiovascular health problems. In addition, the AF patients studied were hospitalized twice as often, had three times the rate of multiple hospitalizations, and had four times as many cardiovascular admissions as patients without the condition, according to a statement from the American Heart Association.”

    It gets worse. When I walk in the doctor’s office (not my EP necessarily), I say “Hello” to the staff person. The answer is always “Copay?” I had to look it up. I thought it might mean “Hello” in some subcontinent Asian country. Ha! Gotta laugh.

    Here’s a pen I’ve got my eye on:

    http://www.d-mom.com/diabetes-365/medtronic-pen/

    Here’s one I’m thinking of bidding on at ebay:

    http://www.ebay.com/itm/Two-Brand-New-BOSTON-SCIENTIFIC-TAXUS-Plastic-Pens-/251695423717

  4. It occurred to me while becoming outraged at a commercial for a drug that can cause cancer that appealed exclusively to the vanity of consumers, that no one else cares. We have become numb to the lack of ethics in medicine. The marketers will destroy medicine. I think they already have, but I’m a bit biased. As someone who has been hurt by a pharmaceutical (cipro kicked me pretty hard – http://www.floxiehope.com), I can admit that I’m biased against pharmaceuticals. It’s crazy that the FDA reviewers can’t do the same. Their egos will destroy us all. These toxins that they are allowing us all to play with are not inconsequential.

  5. GREAT post! GREAT comments! Very sad state of affairs – such that during my last few years before retiring from practice (and from teaching) – I no longer accepted dogma from the FDA because of the problems and bias highlighted by this Dr. John post and the excellent reader comments above = SAD state of affairs …

Comments are closed.