The Safety Gap: Dangerous Devices -- In-Depth Doctor's Interview, Part II

What is your background?

Wells: I had a 24-year career with the FDA. I started as a field investigator, worked my way through several field offices of the FDA, eventually landing in Washington where I spent the last ten years working in the part of the FDA that deals with medical devices then I was in the compliance shop. I was a branch chief in the compliance shop where we dealt with the issues of medical device companies -- policing them, inspecting them and making sure their products were okay.

I left in 2000 and since that time, I’ve been doing consulting -- going into some of the same companies and helping them learn and apply the regulations and things like that to be compliant. In a way, it’s the same job I had before, except now I’m working for the companies instead of the government. Sometimes, it’s actually a little bit easier when you’re going in with the badge, you’re actually going in as a contractor, but the mission’s the same.

When the average person hears things like the peanut scare or they hear something about a drug gone bad, they think automatically you’ve just got to blame the FDA. Why should we kind of take a step back and not just be quick to jump?

Tim Wells: I guess the American public needs to realize that there are a heck of a lot of foods, drugs, devices, cosmetics, and even animal products that are produced in this country or imported on a daily basis. The FDA really has a very, very small force of inspectors, so they use contractors more or less to help them. In the case of the peanuts, they were relying on the State of Georgia and the Department of Agriculture in the state to do their inspections. Maybe the FDA should have been paying closer attention to what the state was doing in that instance, but they can’t be everywhere at all times. Also, the FDA has had increasing responsibilities without incremental increases in resources, and a high turnover rate of talented personnel. So there are really a number of reasons why the FDA has been falling behind in terms of their ability to keep up with what’s going on out there in the food and drug, device, cosmetic and biologics, and animal product area.

Despite all of the news that we hear, do we still have the safest supply in the world?

Wells: America has the safest supply of food, drug and medical device products in the world. We can go to the doctor and feel confident or go to the hospital and feel confident that the products they’re getting are not going to fall apart or break or something during your procedure. But it’s a constant vigilance needed to keep that level of quality up. It’s not something we can take for granted.

What are we looking at right now in terms of approximate numbers of inspectors the FDA has and the amount of work that they have to do?

Wells: There are approximately say, 10,000 or 12,000 employees in the FDA, and of that, less than 10 percent are inspectors. Just to give you an idea, just in the imported area, there are well over a million entries that come into the United States a year that each represents a shipment of food, a shipment of drugs. Just in that one area alone, you can see there are not enough people to check all these entries, so they have to come up with computer systems and cooperative agreements with U.S. customs, etcetera. On the manufacturing side, there are virtually thousands of companies that are manufacturing medical products, biologicals and pharmaceuticals, etcetera. The way the FDA is supposed to operate is, every two years, they’re supposed to be visiting these companies and inspecting them for their quality system or what they call Good Manufacturing Practice, GMP.

Unfortunately, that’s not happening. In some instances, companies aren’t being visited for five years or six years and some companies are now getting visited more frequently – four or five times a year -- because it depends on the risk of the product. If you’re making products that are going into a patient’s heart, you may be visited five, six times a year, whereas if you’re making a product that is a lotion that you apply on your body, which they do regulate, you may not be visited in ten years. If it’s a prescription drug, and there’s some kind of risk associated with it, you may be visited more often, but it’s not a balanced program. I wish they could be more able to meet their two year turnover and visit all the companies on a more scheduled basis.

Does the schedule of inspections change when you go overseas? Do the logistics of it just make it more difficult?

Wells: The U.S. companies are probably more likely to be visited more often probably because they’re conveniently located, and to go overseas requires a whole logistical issue, and pre-announcement -- they don’t just show up on your doorstep like they might here in the U.S. They try to conduct the inspection in a condensed period of time, say five days, whereas as in the U.S., they could be at a factory for three or four weeks, and I’ve seen them there for three or four months on the same inspection, plus they can just bring in more people if they need them, like backup, to help with the audit or the inspection. It’s not that easy to do that overseas, so yes, there is, I’d say, an inequity in terms of the depth and the duration of the inspections. I can also say that there is a different law that applies to a product made outside of the U.S., and if the feels the products are not adequate from overseas, they can just stop them at the port of entry. They have that ability, it’s in our laws, whereas in the U.S., if they find a product is inadequate, they have to go to court and they have to have a U.S. attorney in federal court -- it’s called an injunction or seizure against the products. It’s very, very difficult to achieve such an action in the U.S. Not that they don’t still do it -- they do them, but they have a shorter inspection overseas, but they have a little bit more leeway in terms of taking action. It gets the attention of the foreign companies, let’s put it that way. They’re very concerned about the inspections and try to know that if they only have five days, they really need to do a bang up job during their inspections.

With the changing landscape of where our drugs and devices are produced kind of shifting towards places like China, is it almost becoming lopsided now? Do we need to spend more time overseas looking at those plants?

Wells: It is concerning that over the years, there’s been a shift of an area --pharmaceuticals, for example. The product we call API, the active pharmaceutical ingredient, a lot of these that go into our U.S. drug supply are made overseas and a good number of them are made in third world countries. The first thing that comes to your head is, oh, are they going to be safe? And I think that is a legitimate question and we should all be worried about it. About three or four years ago FDA did a concentrated effort to go and visit them. I’ll just say like, ‘You know what, we’ve been not paying much attention to China, let’s go over there,’ and they did a lot of work to look into this, and they found that they weren’t without issues. In fact, I think that those visits that FDA did a few years ago were the predecessor to what’s now the establishment of FDA offices in some of these countries. For example, China now has FDA offices -- they just built up last year. I think the lack of FDA presence in terms of inspecting drug and device companies and biologic companies could tend to a more lax output from the company. It’s something you hate to think that, but I just think it seems to happen. I think we need a constant vigilance, a constant show of force, more or less, the FDA, even if it’s just a brief visit, but to let people know they’re around and that they’re enforcing our laws and protecting our American product by ensuring the products made overseas are adequate.

Do other countries have similar regulatory agencies?

Wells: Other countries have their own Food and Drug Administration -- they may not call it that, but in Western Europe, for example, they have very strong equivalent agencies, not only the individual countries, but the European Union, more or less, has helped police them. We shouldn’t worry about anything that’s made in Germany or made in Europe, anywhere in Europe. I think that they’re very conscientious and work real hard to get the products of high quality.

The number of plants that are making drugs overseas, especially in China, seems to be growing. Do we need to compensate for that sooner in terms of inspections?

Wells: I think clearly there have been a lot of lessons in the last few years for us as Americans -- the issue with the toys and heparin, which was a medical product that was being made by a company in China, and they were cutting corners, more or less, cheating to change the product, and there have been examples of that with the dog food and baby food and all that. Certainly, if I was a consumer and I saw a medical product made in China, I’d be quite worried about it, even though we say the world’s equal, but we need their government to be strong like I was discussing in Europe, and their internal practices to be strong before we can say, ‘Okay, I’m not going to worry about products coming out of China,’ like I would say about Germany. I wouldn’t worry about it if it was made in Germany. In fact, I would gladly buy a product made in Germany. Look at the German cars. I mean, they’re great.

There is a vigilance, and it’s not like we’re buying tee shirts made in China. What can happen? You throw it away, big deal, but we’re talking about maybe life sustaining products here. I think that there is a reason that we should worry about products that are made in a part of the world that maybe doesn’t have the same standards that we have.

What are some solutions?

Wells: There are a couple of things going on. There’s international harmonization, which is a global effort of governments, and in fact, I worked on some of that when I was with FDA for the global harmonization of inspections. The theory there is to get the governments of the world to agree upon, say, a good manufacturing practice standard, and then try to use their own resources to police and monitor the industry. It’s working in parts of the world. In other parts of the world, China, for example, doesn’t participate in the Global Harmonization Task Force, whereas Japan does and Australia does. There are those types of efforts. There are international standards that are developed by organizations like ISO in Switzerland that help create guidelines for manufacturing products – everything from automobiles and airplanes and medical products – to guide the industries in the world. Getting the companies to comply is probably the biggest challenge.

How concerning are the practices of manufacturers in China?

Wells: It is worrisome, and I think this is why the FDA put their presence in China, because of the fact that we’re relying upon them as a producer. Active pharmaceutical ingredients, for example, and a certain number of medical devices, and maybe other dosage forms of drugs that we need to more or less keep the vigilance in place and constantly, do as much monitoring as we can. It’s a big country. There are a lot of manufacturing locations -- the number of manufacturing sites in China is thousands. It’s still an uphill battle even if we put eight people over there. There are large numbers of inspections to deal with.

Is it unrealistic for us to think that every plant is going to be inspected?

Wells: It would seem to me they would have set up a risk based approach to go in and visit the higher risk sites first. Just like I mentioned about U.S. inspections where they may visit them more often, they would probably go to the sites where there have been issues, where there have been known contamination, for example, or adulteration of some type, and visit those first, and hopefully not send our inspectors to some really low risk situation. It’s sort of a type of risk management where we always want to use our resources in the area where it’s most beneficial. That’s one thing the FDA is really good at, because they’ve always been short of resources. The whole 24 years I was there, we were always, I won’t say behind, but trying to keep up. Technology’s changing, more products have software, and the combination drug/device world is emerging. There are a whole bunch of different things happening that require different skills that traditional FDA people hadn’t had.

There are a lot of challenges -- the whole global manufacturing and keeping up with all that. This is why there is a lobbying effort right now on the part of some individuals to try to beef up the FDA, and I strongly support that. I think that we need a strong government in terms of public health. I think public health is way too important to be cutting back resources, and over probably the last ten years, we’ve seen a degradation. They had a boost of employees a year or two back, but overall I think the trend has been a decrease of resources for the FDA and with the other agencies, as well. Because of this, there are a lot of folks that say, ‘Government is bad, we don’t want government, they infringe on our freedoms.’ While there’s some merit in some of that thinking, I don’t believe there’s merit when you’re talking about public health. None of us want our kids or our grandparents or our family to be in a hospital and have some product failing, or to get a drug and find out it had an adverse reaction that was due to contamination. In the heparin situation, there were deaths, and it was due to contamination, so we don’t want that to happen.

We already have an adverse reporting system in the U.S. for drugs and devices that all these imports go to the FDA. There’s tens, dozens, thousands of reports every year of incidents and adverse reactions and those are legitimate products with good manufacturing practices. We would be flooded with complaints and problems. I think we need to constantly look at the size of our public health staff for the FDA and keep them trained, make sure we have adequate people, and as people leave, bring in more talent, bring in appropriate skills, whether it be software or genetic engineering or whatever. Certainly, engineers, in terms of medical products, are really important. That way, the American public has more protection.

Is FDA funding worse now than when you worked there, or are we just hearing about it now?

Wells: I think we are hearing a lot more because of the speed of the Internet and the news, and right now, FDA is maybe under the microscope. We’ve had outbreaks of public food, food borne illness going back long periods. We’ve had pharmaceuticals, contaminated pharmaceuticals. In fact, the birth of the drug law that FDA uses was due to contaminated pharmaceuticals 60 years ago, so there’s always been that kind of thing, but I do think that maybe the public has grown more accustomed to wanting everything exactly right. Now when they’re starting to learn about things that maybe have been happening all along, they’re saying, ‘This doesn’t seem right to me, why is this happening?’ Had we had the Internet and all this volume of information 20 years ago, 30 years ago, the public may have been a little more accustomed to it, but I think that’s a big part of it. I don’t think we need to stop buying medical products or stop buying food, and change any behaviors as a result of the news we’re getting right now, but rather, I think we should use that news to question our government and see what we can do as consumers to try to ensure we have an adequate FDA, for example.

It’s not just FDA, we have to worry about pollution and labor and all these other things -- that people aren’t being injured on job sites or that they were destroying our environment in the process of making products -- so there’s a need for government in a lot of areas. It’s my personal belief that when you cut back in those key areas, there’s always a cost, and it could be increased pollution or maybe some dips in quality of the food supply, or things like that, so we need constant attention to these laws. The laws were there to protect us, and folks have been put in place in Washington agencies, but then scattered throughout the U.S. to enforce these laws and to inspect companies and I’m talking beyond FDA. I just think it’s important that people can continue to do that work and not the budgetary priorities to be pushed into some other area, and it’s just going to cause a decrease over here, so it’s always a balancing act.

Some of the supporters of the FDA have said it’s fundamentally broken. Do you agree with that?

Wells: I think the personnel that work at FDA are not fundamentally broken. I think the personnel are very high caliber people who go into government, like I did, kind of naïve in your 20’s and thinking that at first you go in maybe because it sounds like a solid job, but, probably hundreds and hundreds of folks come in. After a year or two they think, ‘Wow, this is a fantastic job, I’m actually helping people,’ and you can feel good about it. That’s true today that thousands and thousands of FDA people come to work and feel good about it, and they are making a difference. To me, what I’m seeing as concerning is the pressures that are being put on FDA in some areas maybe causing the balance to change a little bit.

For example, the product approvals that started probably 15 years ago, the emphasis was on product approvals over inspections. In other words, we have X number of FDA resources and we want to get new technology, new products out there, so they had to put resources into that product approval, and then they had to put deadlines on to the product approval. Then they started getting user fees to fund the product approval, but what worries me is that if we focus our mindset on product approval, you might become too focused on helping companies get products in the pipeline than you are in making sure the products that are out there are performing as they promised. With drugs and medical devices both, and probably for biologics, when you submit an application, you’re supposed to do X, Y, and Z, and you may have a study, and often a small study, which looks positive, but it’s not until it gets out there in the real public where it gets used by millions of people when all of a sudden these problems start showing up.

It’s all over the literature. It’s a known fact -- drugs have adverse reactions that aren’t really known because maybe the population that you used wasn’t prone to that particular type of condition. There could be a lot of reasons -- they’re used by more elderly, they may be used by younger people than were in the studies, and the same thing with medical devices. The reason I’m telling you this is that there’s another whole area called post-market surveillance, which is taking in the complaints and initiating action to get the companies to either remove the products if they’re bad or to change their labeling. There’s a whole effort at FDA, both in drugs and devices, that deals with post-market surveillance and they’re falling way behind. They can’t keep up.

Their emphasis is on product approvals because Congress is putting pressure on them to make sure the product approvals are done on time, so I guess that’s one worry. It’s not bad people. It’s the focus that is placed and emphasis that’s placed on the government, the FDA people, and unfortunately, Congress. It’s an odd thing when you work for a government agency like that because FDA is considered an executive agency -- it’s part of the executive branch -- but the Congress is always pulling their chain. Congress can remove their budget or change their budget, so they have to cave in to the pressures that Congress puts on them, and sometimes it’s actually threats where Congress tells them, ‘You must do this or we’ll punish you,’ which is really sad. It’s a problem because I don’t think public health agencies should be subject to political pressures. I think that the recent issue with the medical devices review is purely related to pressure that was put on them. I don’t think those were bad people.

END OF INTERVIEW

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