FDA Failures Continue to Put Patients at Risk

April 5, 2012

5 Apr – In 1957, the Upjohn Company launched the antibiotic Panalba.  The drug was administered to thousands of Americans for more than a decade.  By 1968, Panalba sales totaled $18 million.  After years of complaints related to the drug, FDA Commissioner Herbert Ley Jr., reported that roughly one in five patients who received it suffered a serious allergic reaction – a blood reaction that killed twelve patients.  Although several ten-year-old Upjohn-sponsored studies showed that other drugs were safer, they kept it on the market because it generated roughly 12 percent of Upjohn’s domestic gross income.

In 1977, researchers at the Wharton School (U. Penn) wanted to know whether Upjohn’s social irresponsibility was unique within its corporate culture and, if not, how pervasive it was among US companies.   Their report (Armstrong 1977) revealed that a “substantial proportion of managers may be expected to bring serious harm to others in situations where they feel it is proper behavior for their role:”

Further evidence was provided by the Panalba role-playing study, where 79% of the groups selected a highly irresponsible decision and none chose the decision that was free of irresponsibility. These results were due to the pressure of the role rather than to differences among individuals; differences in irresponsibility were not related to nationality or to age.

The stakeholder role led to a reduction in irresponsibility. Instructions that a board member should represent all interest groups, along with the evidence on how these groups were affected, led to a reduction in irresponsibility as only 23% chose the highly irresponsible decision. Reductions also occurred when the interest groups were represented on the board of directors; 22% of these groups selected the highly irresponsible decision.

Armstrong’s finds were consistent with Milgram’s conclusion from their obedience studies [42:6]:

“… ordinary people, simply doing their jobs, and without any particular hostility on their part, can become agents in a terrible destructive process. Moreover, even when the destructive effects of their work become patently clear, and they are asked to carry out actions incompatible with fundamental standards of morality, relatively few people have the resources needed to resist authority.”

Despite this disturbing report, little has changed within the US drug, device and healthcare industries.  Companies like Merck, GlaxoSmithKline, Eli Lilly and Pfizer routinely pay billions of dollars in fines to settle thousands of cases related to the illegal marketing of drugs that kill or injure millions of Americans annually.

But because drug and device companies are allowed to create shell companies to admit guilt, CEOs and shareholders typically pay a fraction of their profits in settlement agreements, leaving CEOs and shareholders with sizeable profits for their deadly decisions.

The latest example of these decisions was reported last week by CBS reporter Jim Axelrod:


Statistically, fewer than one percent of all medical devices fail their patients – far fewer, in fact. Small comfort if one of those very rare failures strikes you or me or someone you love. Our Cover Story is reported by Jim Axelrod:

Joshua Oukrop was 21 when he died seven years ago of a heart attack. Robert Hauser is not a relative; he was Joshua’s cardiologist.

“How often do you think of Joshua?” Axelrod asked.

“Every day,” Dr. Hauser replied. “He was young. It shouldn’t have happened. It just shouldn’t have happened.”

The story of what happened to Joshua begins with the discovery as a teen that he’d inherited a heart condition from his father, Lee.

“He came home from band and his saxophone was dented in a little bit in a few spots,” Lee Oukrup said. “And he said, ‘I just passed out and fell forward.’ So we knew something had to be done.”

Josh’s parents took him to see Dr. Hauser at Abbott Northwestern Hospital’s Minneapolis Heart Institute. Hauser decided to implant a cardiac defibrillator – called an ICD – in Josh’s chest.

“When the heart becomes very chaotic, it shocks the heart back to normal,” Dr. Hauser said.

Although Lee Oukroup and his older son, Jacob, both had similar heart conditions, neither had shown signs of disease. So only Joshua had an ICD implanted.

“He was a kid, you know? He was a little reluctant to do it, but he knew it was for the best,” Lee said.

Three years of routine tests and check-ups went by uneventfully. And then, in March 2005, Joshua Oukrop took a biking trip in Utah with his girlfriend.

“His girlfriend saw him fall off his bike and collapse,” Dr. Hauser said. “CPR was attempted but he could not be resuscitated. . . . He died.”

Lee Oukroup said the county coroner told him that Joshua’s ICD was faulty. Instead of shocking Josh’s heart back into rhythm, the device had shorted out.

Josh’s doctors asked Lee for permission to remove Josh’s heart and examine it: “I tell you, it was a very, very hard thing for me to do. I wanted my son whole. But I agreed to do it and they brought it back to Minneapolis and they autopsied just the heart itself. And they found out that it was a very shockable heart. He could have been brought back to life had the device worked.”

“Had the device worked …” Crushing words to Dr. Hauser, and intense motivation as well. How could the device have not worked?

“I got into the FDA database,” Dr. Hauser said. “And my search uncovered a number of problems.” He found the ICD’s manufacturer, Guidant, had known the defibrillator was faulty since 2002.

“We eventually met with Guidant in May of 2005,” Dr. Hauser said. “This would be three months after Joshua’s death, and we told them they were obligated to inform patients and physicians of the problem.”

“What did they say to you?” Axelrod asked.

“They declined to do so. They stated that they were afraid physicians would overreact and take these devices out unnecessarily, because they believe that the likelihood of failure was very low.”

Dr. Hauser said that, as a result, tens of thousands of people were walking around with a faulty defibrillator.

So he told his story to The New York Times: “That defibrillator was recalled,” he said.

Guidant was taken over by Boston Scientific, which declined to comment, saying it was “not interested in participating” in our report.

But that’s not the end of the story.

Dr. Hauser kept digging. He says he found problems at the FDA – the agency charged with approving and overseeing medical devices. He believes both the approval process and the follow-up once devices hit the market are badly flawed.

“In this whole episode, where was the FDA the whole time?” Axelrod asked.

“I don’t know,” Dr. Hauser said. “The FDA should have been on top of this, because Guidant had filed a report with the FDA in August of 2004 laying out the details of the problem with the device.”

Marcia Crosse, health care director at the Government Accountability Office, the federal government’s watchdog agency, is in charge of FDA medical product oversight. She said she knows the FDA had the reports but can’t say if anyone read them.

“The data we have from our review of recalls showed that FDA had approximately 26 reports of serious adverse events related to this type of device over a three-year period before the device was recalled” in 2005, said Crosse.

Crosse said that despite 26 reports of adverse events, there was no recall until after the report of Joshua’s death. “It was I think the reports in the press of this patient that was the precipitating factor for the recall,” she said.

“Forgive me, but is that what it takes?” Axelrod asked.

“It shouldn’t be what it takes,” Crosse replied. “That’s the concern that we have about their use of information that they receive. That is the kind of concern that we have.”

Crosse says the non-partisan GAO put the FDA’s oversight of medical products on its list of government areas at high risk for mismanagement and in need of broad reform. But, she says, the problems go back much further.

“The responsibility for reviewing medical devices was first given to FDA in 1976,” she said. “The expectation was that FDA was going to put out regulations for each type of medical device. And by 1990 FDA still had not put out regulations for these high risk medical devices – over 100 different types.”

In fact, according to Crosse, 22 types of important and potentially life-saving medical devices – from automated external defibrillators to electroconvulsive therapy devices – remain without proper regulations.

Among these devices: Metal-on-metal artificial hips which have been the subject of a recent recall. Tiny metal shards can break off, releasing toxins into the bloodstream. It’s believed that some 500,000 patients could be affected.

The metal-on-metal hip was allowed to be grandfathered-in on the approval of a similar device already on the market.

This, says Dr. Hauser, is a faster and cheaper method to get a product approved. And it’s a fundamental (and not uncommon) problem.

“Companies are allowed to supplement a new device on a previous approval without conducting any human safety tests,” Dr. Hauser explained. “For example, there was a defibrillator lead that functioned very well. The manufacturer decided that they wanted to make a smaller version of the lead. So they shrunk it up. They used the same materials basically, same design basically. Very quickly it became the most popular lead ever.

“After two years of being on the market, it started to break. They may look the same from a material standpoint, from a design standpoint, but they perform vastly differently.”

We asked to speak with the FDA directly about all of this. We made repeated requests for an on-camera interview. While the agency was weighing its response – we talked with some of its defenders:

“The FDA, you can always try to do better, but I think the FDA basically does a very, very sound job,” said David Nexon, a senior executive vice president at Advamed, a medical device trade group.

“Some of the critics, you know, I think want a zero-risk system, where nothing is ever approved unless it’s shown that they can never do anybody any harm. If you do that, you also have no medical progress, and that’s not a good thing for the American people.”

In fact, Nexon’s group thinks the approval process is too slow.

“The industry’s concern about the FDA in the last few years is that while they haven’t changed their standards for review, reviews have become much slower and more inconsistent,” Nexon said.

But Dr. Hauser cautions that speeding up an already ineffective approval process could be dangerous, because there’s also inadequate follow-up after a device hits the market – something called post-market surveillance.

“In the United States, there is no definite requirement for post-market surveillance for defibrillators and heart valves, artificial hearts and so forth,” he said. “There’s no absolute requirement. In other words, you wait for problems to be reported to you rather than actively seeking out problems, and there’s a big difference.”

He says active reporting could have saved Joshua Oukrop. Remember, the GAO says the FDA received 26 reports during the three years before Oukrop’s death.

“I suspect nobody read the report,” Dr. Hauser said.

“FDA has got to know there’s a problem here,” said Axelrod.

“They do, and Congress knows they have a problem,” Dr. Hauser said.

“So when you say there can be tens of thousands of people walking around with faulty devices, I mean, really, tens of thousands? It doesn’t have to be, in your view?”

“No,” Dr. Hauser said.

Last year, the Institutes of Medicine, an independent advisory group, issued a report stating that the FDA’s current regulatory framework for most devices is so flawed it should be thrown out and replaced with a new system that “provides a reasonable assurance of safety and effectiveness.”

Advamed’s David Nexon says that even though in the last couple of years recalls of device models with problems that could cause serious injury or death have doubled, in his view, the numbers are still small.

The American people, Nexon said, “should be very confident that the FDA and the industry working together have an exemplary safety record. There are 50,000 different models and devices on the market right now. About 20 of those on average they find serious problems with. That’s less than two-tenths of one percent.”

Lee Oukrop asks, “Why did I have to be the 1 percent? Not wishing it on anybody else, but why does there have to be any? There shouldn’t be any. There can’t be. When it’s that critical of a piece, there can’t be that kind of problem with it.”

When we finally heard back from the FDA – the agency refused our request for an on-camera interview, providing us instead with a lengthy statement, which said in part:

“The FDA weighs the benefits and risks of every medical device we review. … We must balance risk with the careful evaluation of patient benefit – this helps promote public health.” (full statement)

Today, Lee Oukrop worries for his other son, Jacob, who inherited the same heart condition as Joshua – and has a defibrillator implanted inside him.

“I mean, I feel confident that it will save me if and when I ever do need it,” Jacob said. “They have assured me that this device is a life-saving device and I just put my trust in what the doctors say.”

But this isn’t Jake’s original device. As the luck of the one percent would have it, a part on Jake’s defibrillator was faulty. Remember those smaller leads Dr. Hauser described? Jake was among the 268,000 patients who received that “shrunken up” version.

“There was a recall on some of the leads that go from the defibrillator to the heart,” Lee Oukrop explained. “The leads were cracking and shorting, and then the defibrillator couldn’t deliver a charge if it needed to.”

After having that device inside him for nearly three years, it was replaced before Jake was harmed.

But 13 others died.

Lee Oukrop says Jake just had better luck than Joshua – and that’s not nearly good enough.

“Somebody out there needs to be looking out for me, for us,” said Lee. “We’re not doctors, we’re not scientists. Here it is six, seven years later, and you still see that stuff is getting through. Stuff is being recalled. And it’s all stuff that the FDA should be looking at and they should be paying a little bit more closer attention to.”

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