Last month, we posted Part I of our interview with Public Citizen’s Dr. Michael Carome, who is the director of the Health Research Group (HG). He shared some of the watchdog group’s efforts to hold pharmaceutical and medical device companies accountable.
On this second and final part of the two-part show, Carome discusses the role the government and physicians play in keeping citizens safe. In addition, Carome shares Public Citizen’s position on the Affordable Care Act.
Carome said one of the ways physicians can look out for the best interests of their patients is to act independently of the drug reps who often show up at doctor’s offices.
“Too often, physicians welcome their relationships with some of these product manufacturers. They will promote the products to their patients, particularly in the realm of devices, and that’s not always in the best interest of patients,” Carome said.
Some of the studies that drug reps present to physicians are conducted by their own researchers and might be biased. Carome says that physicians should be proactive in staying independent when it comes to information as well.
As a physician himself, Carome has always worked to uphold the ethical treatment of patients not just in the doctor’s office, but also in clinical trials. Prior to joining Public Citizen, he worked for more than a decade at the Office for Human Research Protections. There, Carome fought to keep participants of human clinical trials from being exploited.
He continues this work with Public Citizen. Recently, the organization spoke out about a change in the wording of some of the regulations involving clinical trials and the money paid to participants. Prior, the long-standing policy was that the money paid out should never be so high that people who would not otherwise participate in a trial would do so solely for the money.
Offering too much money in these cases may cause those who are “economically disadvantaged” to take health risks they would otherwise not take.
“The Office for Human Research Protections issued a revised policy … basically saying it’s OK to pay people to accept risks that they wouldn’t otherwise accept,” Carome said.
Public Citizen wrote to the secretary of Health and Human Services, Kathleen Sebelius, asking her to direct the Office for Human Research Protections to rescind the policy.
The Affordable Care Act remains controversial. Millions of Americans are still caught in the middle, making too much money to qualify for subsidies, but making too little money to afford coverage.
Parts of the law are fraught with problems that cause delay. Just this week, the Obama administration announced that it would delay implementing a requirement that businesses with more than 50 employees but less than 100 provide health care coverage to their employees, until 2015.
Public Citizen doesn’t feel that the Affordable Care Act is the health care solution America needs.
“We are ardent advocates and champions for a single-payer health insurance,” Carome shared. “Although more people will get coverage (under Obamacare) and that is a good thing, ultimately it is going to fall way short and leave tens of millions of people uninsured or underinsured.”
Until for-profit businesses are eliminated from the health care insurance system, Public Citizen feels Americans won’t get the health care system they need. Carome points out that Medicare overhead is about 3 percent, far lower than that of private insurance companies.
Ideally, a revamped version of Medicare would be a good model for national health insurance, he said.
Welcome to Drugwatch Radio. I'm your host, Michelle Llamas. This episode is the second and final part of a two-part podcast featuring Dr. Michael Carome of the advocacy group Public Citizen. In this episode, Dr. Carome discusses the FDA, drug companies and the Affordable Care Act. He joins me by telephone from Public Citizen's offices in Washington. Here is a recorded telephone interview.
And you probably still have a lot of colleagues obviously in the industry and it's interesting because as an advocate for a lot of these safety measures and bans and things like that. . . . How did it affect a doctor's practice? Because there is obviously so much going on like you've got drug reps coming in trying to say "well our product is better, here's some studies on this" and that might not even be as safe as they say it is because again they're providing information based on their own studies. So how do you think a doctor can sort of navigate this industry as someone that's concerned about doing the best thing for their patients?
I think it's important for physicians to seek information about these products independent of drug reps and industry promotional materials. They need to look at the literature, they need to go to other independent sources for information, and do better assessments that don't rely upon what is clearly biased and slanted information that comes from the industry. Too often, physicians unfortunately welcome the relationship with some of these product manufacturers. They will promote the products to their patients, particularly with devices, and that's not always in the best interest of patients. Unfortunately, many times it's only in the best interest of the company that's making that specific product. And so we think physicians need to be independent of the drug reps and the medical device reps and not allow themselves to be influenced by them.
Yeah, and I suppose you probably also advocate for more transparency in some of these clinical trials and studies, right? You can't really cherry-pick the studies that you want to show people that show that your product is safe or effective, which I think happens quite a bit obviously as far as the drug reps and drug companies are concerned. Now, when you came, you said you joined Public Citizen and you basically – I’m not sure if this is a full-time job, obviously, it's a lot. How did you first become involved in Public Citizen and what was the personal stake in this for you as an advocate?
Let me just give you a little bit about my background.
I'm a physician. I earned my medical degree at Case Western Reserve medical school and I subsequently practiced. I did an internal medicine residency and a specialty fellowship training in nephrology at the Walter Reed Army Medical Center. And so I practiced medicine in the army for several years. I subsequently left the army and entered the public health service and worked for 11 years at the Office for Human Research Protections, which is the office that oversees protections and ethics for human research and clinical trials.
You were involved in the ethics and the watchdog type activities already, right?
Exactly, and so I was at the Office for Human Research Protections from 1997 up until my time of joining Public Citizen. And as I became eligible to retire from public health service, I explored other opportunities and learned that Public Citizen's health research group had an opening in its deputy director position, and I applied and joined the group in January 2011. It's very much a consumer advocacy type of work that I thought was parallel to the type of work I was doing before in the Office for Human Research Protections.
Now, we talked about some of the things that Public Citizen has been able to do as far as pushing forward some protections and legislations and bringing things to light to the FDA. Does it ever get very difficult for you? It's obviously an uphill battle for some of these projects that you choose. How do you continue to keep fighting and keep going with your work whenever you come up against stone walls probably from either pharma companies or the FDA itself?
Yeah, one has to be persistent – [laughs]
In your activities of advocacy, that one must not give up, one has to keep trying. So over the last four decades Public Citizen's health research group has petitioned the FDA to ban 38 drugs from the market. And of those, 25 or almost two-thirds are now off the market, many because of our efforts to get them off the market. And several others are restricted so we try to pick projects, particularly those related to drugs, where we think the evidence is strongest and we're most likely to have some success and I think our record reflects a relatively good track record. Some of those withdrawals, it took many years of that decade to succeed, and sometimes required petitioning the FDA more than once. The drug Darvon, Dapoxetine: a pain reliever that ultimately was shown to have significant toxicity to the heart. We had petitioned that to come off the market back in the late 1970s and then tried again several times. It finally came off the market a couple years ago.
Wow, yeah, so you're talking about a couple decades there.
So one has to be persistent in this area, but if you are persistent, and the evidence is there, in many cases one can be successful in one's advocacy efforts. And so that ultimately is rewarding, and reinforces that the work is important and can succeed, and so one has to be persistent.
Now you've mentioned some clinical trials. We talked about them and how important they are to a lot of these drugs and testing the safety, but you're also involved in making sure that the clinical trials processes themselves are ethical, because I believe recently also I received some information from Public Citizen about the slight wording change in some of the Department of Health and Human Services' wording to the rules of, shall we say, having these human clinical trials and that there might be a little bit of conflict of interest there when it comes to the money that's being paid to participants.
Exactly. So we do do some work regarding the ethics of clinical trials for human subject research. It's not the majority of our work. Lately we have done quite a bit on this topic. You may have heard about some of our work. We were invited to some clinical trials in premature babies that we had some ethics concerns about.
But on the issue you just raised, the Office for Human Research Protections has a long-standing policy addressing the topic of how much is it appropriate to pay human volunteers to be in research trials.
Yeah, now real quick before we continue, I just want people to know about some of these, because I think most of us have heard these commercials on the radio. Correct me if I'm wrong if this is the type of stuff we're talking about here, where they said "Oh, we're conducting a study on X and you may be paid for your time and travel." Is that kind of what we're talking about here? That money that they pay for people to be a part of the trial? Is that kind of the same thing?
Many people who otherwise wouldn't enroll but for the money, and for many years, the Office for Human Research Protections within the Federal Department of Health and Human Services had a policy that basically said, the amount of payment or the amount of financial remuneration should never be so high as to cause a person to volunteer to be in research, to accept the risks of research, that they would not accept if but for the payment.
I see. Mmm, hmm.
And that to us seemed like a generally reasonable policy because it could lead to people enrolling, sort of being unduly influenced to enter research when they otherwise wouldn't, particularly if they're in circumstances where they're poor and financially and economically disadvantaged. And the Office for Human Research Protections issued a revised policy simply eliminating that sentence and basically saying, "Actually, it's okay to pay people to accept risks that they wouldn't otherwise accept." So it was really a complete reversal of a long-standing policy, although we're talking about one sentence in the policy, it was a fundamental part of that guidance, and we had two concerns. One concern was that the process they used. They did such a dramatic change in policy we thought should have been put out as a draft for public comment so different people could weigh in, and that was not the case in that they basically issued a final policy without doing that. And then we were concerned about the content of the change. We think this policy change could lead to more exploitation of people who are vulnerable to undue influence and more easily exploited because of their socioeconomic status.
So this is almost a predatory thing, right? That it almost seems that way because they're almost targeting a certain group of people without even saying it, right? That it could lead to that. So yeah, continue.
So what we did was we wrote to the secretary of Health and Human Services, Secretary Sebelius, and asked her to direct the Office for Human Research Protections to rescind the policy and if they want to pursue this policy to issue it in draft form and for public comment, and at this point we're waiting to hear back.
Yeah, you just did this. So it seems to me, and I've followed Secretary Sebelius, I really do like a lot of the work that she does so hopefully we're going see something in response to your letter. [laughs] But are there any other projects right now or campaigns that you're particularly concerned about and think need more awareness as far as the public is concerned? I mean it's hard to say one is more important than the other I suppose because these are all important, but maybe a concerning thing that you see?
Yeah, I mean for us, this is a little off-point in terms of drug and device safety, but we are ardent advocates and champions for a single-pair health insurance.
Ah, I see, okay.
We believe that the Affordable Care Act is not the right solution to ensuring that there's universal coverage for medical care for all citizens of this country. We think although more people will get coverage and that is a good thing, but ultimately it's going to fall well short. It's going to leave significant – tens of millions of people uninsured or underinsured and many of the problems that we have today will persist, and the real solution that's needed is a national single-pair health plan like Medicare, but an improved Medicare because Medicare has problems.
We need to eliminate the for-profit businesses, particularly insurance companies, that are just consuming a huge amount of healthcare dollars.
And see I was going ask you that, now because that's still private. Even though you got the Affordable Care Act going, it's still privatizing healthcare.
That's right. We know that from that Medicare overhead is like three percent, much lower than the overhead you have from private insurance companies who are profit-driven and the market is not. The market is so manipulated and driving up costs and so the Affordable Care Act is not the solution. And so we are ardent champions, we remain ardent champions and continue to lobby for single-pair health plans because that's going to be the only way to solve the problems with the health care system in this country.
Yeah, and I think when the Affordable Care Act was first mentioned, many people thought that it was going be something that was kind of like Medicare, but obviously [laughs] you have the corporations that get involved and I suppose like you were mentioning, until that sort of financial interest is taken out the picture, you probably aren't going have the true coverage that most people are hoping to have.
Right, and you're right. There were some who within Congress who tried to have a public insurance option within the Affordable Care Act so that people could buy into a Medicare-like program and that was overwhelmingly opposed by the insurance industries.
Because they realized people would want that. They would be out-competed and that's because it would have delivered better health insurance to people than we're going to get.
Yeah, and affordable. Probably even way more affordable than what's going on now. I don't know if you know much about the actual affordability of the Affordable Care Act, which I think is interesting. A lot of critics say that it's actually not going to make the insurance affordable like people expect it to. So I suppose is that again, because of the whole private companies still being involved in it?
Absolutely. So it's not going to make it affordable. It's going to leave many people without insurance despite the penalties. They say they can't afford it, so they're going to get penalized by the government, and ultimately, the system's going to give. Because it is so complex. The complexities that I'm talking about are not related to the failures of the website.
Oh, yeah. No.
Which is a separate complexity, but the complexity of the marketplace of what the law does is adding additional costs to the system that could be done away with if we had single-pair.
As, for example, Canada has. And unfortunately, it's going to take a lot more advocating to achieve that, but we believe ultimately that's what's going to be needed.
And the thing is is that as a consumer, when I first heard of the Affordable Care Act, I actually thought it was going to be something more like what Canada's got going, and then you've got all this media that goes into it and will throw in the buzzword – "Oh, socialism" – and people get all up in arms about it, which, I always think is interesting. But you mentioned so many points that I think the average person isn't aware of with the actual laws themselves so, how can the average person – say you're really concerned about a lot of these things that we just brought up. Is this something that is difficult for someone just to find out about on their own?
In today's world with technology, Internet technology, many people can educate themselves if they go to the right sources of information. People who are interested in these issues and seeing stronger advocacy about these topics, they can support groups like Public Citizen. We don't...our group doesn't take money from corporations or the government. We depend on support from our members, from some of our newsletters people can subscribe to, like our Worst Pills, Best Pills news.
And in order to fight these well-funded corporate lobbyists, groups like ours need support, because the other side is very powerful and very well-funded and so that's one way to help. There are other organizations like us and people need to stay informed about various issues, and you can do that through the types of newsletters we do and through other sources of independent information. And people who have particular concerns about having the FDA improve its performance, to be more accountable, people can contact their congressman or senators and urge them to provide stronger oversights to the agency. Too often, Congress falls down and doesn't do the oversight that's needed over some of these agencies, and ultimately Congress needs to provide better funding to these agencies so they can be independently-funded to do their important work.
Yeah, so that right there you mentioned is very important, the whole funding issue, because you get all the conflicts of interest once the industry that's being regulated starts funding their regulators. [laughs] But yeah, that's great, I'm glad you mentioned how people can be involved and I think a lot of individuals sometimes think that their one contribution doesn't make a lot of difference, but I think you can probably speak to that, right? That it does, that people can get involved and by contributing to third-party independent organizations like Public Citizen they can actually do something about these things.
Absolutely. To resist the corporate powers that are controlling our government, affecting our agencies, individual citizens need to stand up and have their voice be heard, and they can do that individually and through groups like ours and other advocacy groups.
Well, thank you so much for being a guest on the show and you know, you provided so much really important information that, again, the average person might not know about, and at our show we kind of try to do the same thing. We sort of just put the information out there and hope that people get it and try to make it more accessible, so thank you so much for your work. As a fellow advocate anyway, I look up to groups like Public Citizen, and I really appreciate you doing the job that you do, so thank you.
You're welcome, and thank you for having me.
Thank you for tuning in to Drugwatch Radio. It was a pleasure speaking to Dr. Carome. If you have any questions or comments, please send an email to firstname.lastname@example.org, or you can tweet me on Twitter @drugwatchradio. You can also visit the Drugwatch Facebook page and join the conversation. Thanks for listening.
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