It is a sad day when some guy sitting at his home computer can find evidence that the FDA is no longer serving the public interest, while the major news organizations don’t seem to care.
I suppose it shouldn’t be surprising, considering that the EPA has become a tool of polluters rather than an agency protecting the health & welfare of U.S. citizens, but most of us have a difficult time accepting that the Food & Drug Administration has gone from serving the public interest to serving the interests of pharmaceutical buck-junkies.
A recent story caught my eye about an FDA warning letter sent to Novartis Animal Health U.S. Inc. Novartis tested an animal painkiller called Deremaxx, which is in the same chemical family as Celebrex and Vioxx, both linked to heart attacks in humans, and the Novartis experiment resulted in an inordinate number of dead cats.
The FDA requires that results of experiments like these be reported, but Novartis didn’t bother. The experiment took place in July of 2003, but only after a February 2004 FDA inspection of the drug maker’s facilities did Novartis submit the required reports.
The FDA also requires that drug companies submit a study plan prior to conducting experiments, but Novartis didn’t submit a plan at all – until three months after the study was concluded.
The FDA issued a letter of warning.
Odd, I thought, that such blatant disregard for FDA regulations would result in nothing more than a letter of warning, so I decided to look into it a little further.
What I found, to be frank, was a bit terrifying.
A quick Google search turned up three current newswire stories about FDA warning letters issued to drug companies. Besides the Novartis letter, one was sent to Chiron Corporation, the flu vaccine manufacturer whose U.K. plant was shut down due to contamination, which in turn caused a shortage of vaccine for this year’s flu season.
In early October, regulators in the U.K. shut down the plant because of wide-spread sanitation problems. Later that month, after outrage in the U.S., the FDA inspected the facility as well. The FDA issued a letter of warning, but not until December.
The letter contained hardly any “warning” at all. The FDA simply asked for more information on Chiron’s plans to address the problem. In the meantime, U.K. regulators decided that the problem were not being addressed at the Chiron plant, and extended the closure until April, 2005. Apparently, had the U.K. regulators not stepped in, the plant would still be in operation.
Yesterday, news broke that the FDA letter-writers had been at it again. This time, they sent a warning letter to a Houston-based company called Cyberonics, which makes implantable devices to treat epilepsy. The FDA informed Cyberonics that the manufacturing plant did not meet U.S. requirements.
The FDA inspected the Cyberonics plant for two months, from July to September, and raised the issues with the company at the end of the inspections. Cyberonics responded to the FDA inquiry, but the FDA found the company’s response to be incomplete and evasive. Finally, last month, the FDA sent another letter of warning to warn that the previous three letters of warning sent in 2004 had not been addressed.
The FDA’s December letter to Cyberonics is shocking…and a little sickening.
After the 2004 inspection, the FDA asked Cyberonics to explain “a number of significant QS regulation violations.” Not only did Cyberonics refuse to adequately address the issues, but it basically told the FDA that they were the ones who approved the design of the device, so Cyberonics shouldn’t be held accountable.
The FDA’s letter is a laundry list of despicable practices by Cyberonics. Among those:
* The failure of Cyberonics to investigate and evaluate the cause of each “medical adverse event” caused by its device, as required by law.
* The failure to provide any documentation of the deliberations that led the company to claim that it could find no reason why its implanted device would migrate through the patient’s body unexpectedly, leading to an increase in the severity of seizures, and many deaths.
* A failure to establish procedures for validating the design of the device.
* A failure to test the device design in actual or simulated conditions, which is required by law.
* A failure to explain Cyberonics’ assertion that no “real-time” testing was needed to determine the longevity of the implant, which is placed in a patient’s chest, or any evidence to back up the theories it used to determine the device’s life-span.
* A failure to determine even the most fundamental qualities of the device, such as the impact of more frequent usage in some patients on the device’s battery life.
* A failure to investigate patient’s complaints that the device longevity was too short. Cyberonics refused to consider these “product complaints” and didn’t bother to collect any information from the patient or the patient’s device to determine if the device had any problems.
* A failure to document death data in patients that used the device, or compile the data according the age category as required.
* Failure to investigate the complaints from doctors who said the device didn’t deliver the proper amount of electrical current during the last 6-12 months of the device lifespan.
* A failure to investigate its work operations, processes or other areas that might result in “non-conforming product.”
* A failure to provide information that Cyberonics had collected regarding adverse events related to its product.
* The finding that Cyberonics used bogus explanations for over 1000 patient complaints, coding them as situations that simply required removing the device and implanting another.
* The failure to collect any information on patients using its device over the past five years that might prove or disprove the company’s theories about long-term usage.
* The failure of Cyberonics to implement any changes that were needed to prevent or correct identified problems.
* A failure to document, investigate or analyze the reasons for “thousands of reimplants since 1997.”
The list goes on, and even the FDA admits that its letter is not a definitive list of all the problems at Cyberonics, but it gets worse.
The FDA noted that Cyberonics didn’t follow its own policy on notifying doctors when there had been a “user error.” The company did not send letters to 197 doctors who reported serious injuries in patients, or to 99 doctors who reported device malfunctions, or to 53 doctors who reported that the device caused a patient’s death – but Cyberonics coded all of these complaints as “user error.”
It gets even worse still. Many of the patients using the device were under the age of 12, yet use in children has not been approved by the FDA. That makes it an “off label” use, so all of the complaints that involved children were automatically coded as “user error” and no further investigations were conducted.
Even in these cases, Cyberonics did not send letters to the doctors prescribing the device that could have helped explain how to avoid those deadly user errors in the future.
In light of all these violations of law and regulation, and after having sent warning letters to Cyberonics in years past, the FDA still did nothing but issue another letter of warning.
How can this happen?
It’s simple.
You may have heard before about “off label” uses for pharmaceutical products. A few years back, it became a huge debate in congress. The GOP was adamant that pharmaceutical companies had the right to promote uses of their products that had not yet been approve by the FDA, the so-called “off label” uses, which makes perfect sense if you think whoring for a dollar is more important that the safety of our citizens.
The Clinton FDA prohibited drug companies from promoting unapproved usages of their products, but the GOP led the fight to have that rule overturned. Under the guise of giving doctors “freedom,” the Republicans weakened the power of the FDA to oversee and regulate pharmaceutical companies. Ironically, they prohibit doctors in other countries that receive financial aid from the U.S. from discussing valid, approved reproductive choices with their female patients.
In this paper from the U.S. Senate Republican Policy Committee, they brag that they had successfully “clipped the FDA's wings.”
This, of course, is all in the name of the free market. We certainly want those struggling pharmaceutical companies to be able peddle any faulty device or medication they can concoct, even when it results in the deaths of children.
Now, the FDA is nothing more than a sham.
In all, the FDA sent 36 warning letters in 2004. Some of those companies, like Cyberonics, have received multiple warnings in the past, yet nothing is done. If not for legitimate U.K. regulators, we would have surely been injecting people with contaminated flu vaccine this year.
If you are ready to get pissed off, check the letters out for yourself. Notice how many companies are being "warned" that the promotional materials they provide to doctors are misleading, or fail to properly warn of dangerous side-effects. Also notice how many of those companies have been warned again and again, and then notice how lame the "warnings" contained in the letters actually are.
At what point will the FDA stop warning companies like Cyberonics, and do something to protect us? The FDA now serves the industry it was designed to regulate, just as our nation's leaders serve any industry with the bucks to buy their influence.
