The agency’s scientific reviewers repeatedly and unanimously decided that the device, known as Menaflex and manufactured by ReGen Biologics, was unsafe because it often failed, forcing patients to get another operation.
But after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four congressmen, agency managers overruled the scientists and approved the device for sale in December. All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey.
The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.
It’s FDA corruption déjà vu.Grossly Under-Resourced
You’ve had heart attacks from Vioxx and Avandia and contaminated toothpaste from China; E. coli in your spinach, and salmonella in your spinach and peppers. Tainted pet food has killed hundreds, if not thousands, of your pets. And your children have gotten sick from toys painted with leaded paint.
What will be the next ill-fated product “approved” by the FDA?
The agency’s list of corruptions and collusions is now a mile long. And each piece of new legislation aimed to improve its function seems to do just the opposite—making the FDA even more dependent upon financial support by Big Pharma.
Perhaps the fact that the agency is now publicly questioning its own procedures and affiliations is a step in the right direction. But will that be enough?
The FDA has 11,000 employees and an annual budget of about $2.2 billion. Some experts say it needs double that. Of the $2.2 billion, about $1.7 billion comes from Congress while the remaining half billion dollars comes from drug and medical device manufacturers’ “user fees.”FDA is “Fundamentally Broken”
The agency is responsible for overseeing products that account for one quarter of consumer spending in the US, including all prescription and over-the-counter medications, medical devices such as heart valves and stents, and your food and blood supply.
Yet, the FDA’s budgetary increases have not kept pace with current demands, leading to reliance upon funding sources with private interests and financial motivations, rather than safeguarding your health.
In fact, nearly all of their budgetary increases in the past five years have come from Big Pharma, not Congress.
The FDA itself admitted it lacks the competency and capacity to keep up with medical and scientific advances such as the new wave of high-tech drugs and devices, and products resulting from breakthroughs in genetics, nanotechnology and bioengineered foods, among others--all requiring FDA resources.
Making matters worse, FDA employees have been abandoning ship for richer sailing. And guess where they are going?
Of course, the old revolving door is well oiled and still working quite nicely, so they are going to the pharmaceutical companies, who offer MUCH bigger paychecks as rewards for their faithful service to the drug companies when they were at the FDA.
The result is that the remaining staff is leaner and less competent, including the scientists who make decisions that affect you.
One former FDA employee of 27 years stated that the FDA is “close to its tipping point, and has been hanging on by its fingertips” for a very long time.
All of these factors help to explain, but not excuse, the behavior of the FDA, in terms of its complicity with the pharmaceutical industry and lobbyists. This system has devolved into one that is set up to protect the big businesses that fund it, leading to secrecy, corruption, and a boatload of unethical practices.
The truth about unethical FDA practices has been emerging, bit by bit, over the past few years, which could explain why the FDA is now beginning to change its defensive tone. What was once criticism relegated to the conspiracy theorists is now bleeding into the mainstream.Internal Oversight is Overlooked
Not unlike what has come out about RenGen’s Menaflex device, an article in the Wall Street Journal tells the story of a group of nine scientists from the FDA that sent a letter to President Obama’s transition team in January about the corrupted and distorted scientific review process for medical devices.
In the letter, they pleaded with the President-elect to restructure the agency, saying managers ordered, intimidated and coerced scientists to manipulate data in violation of the law.
These nine scientists described the FDA as “fundamentally broken,” an atmosphere where honest employees fear dishonest employees. They gave details about scientists being threatened with disciplinary action if they dared dissent from management. Members of the Obama transition team did not publically respond about what they planned to do about the allegations.
Why would an honest scientist stay in a work environment like this?
Medical devices receive little more than a cursory review by the FDA. And after a medical device has received the FDA stamp of approval for any purpose, the FDA has no authority to regulate its actual use. Full-body computed tomography (CT) is a prime example of the damage that can result from this.
In July of 2007, the US House of Representatives passed the bill HR 2900, which was a meager effort to reduce conflicts of interest within the FDA. However, it took conflict of interest to a new plateau by tying the FDA even more tightly to business interests.
The FDA is supposed to disclose financial relationships between researchers and medical/pharmaceutical companies as part of the FDA review process, disclosing conflicts of interest. For every study submitted to the FDA, the agency is required to submit financial disclosure information on each investigator. Although this looks good on paper, it isn’t happening.
In January of 2009, an analysis by the Office of Inspector General (OIG) showed that 42 percent were missing the required financial disclosures by the investigators. The report stated:“Financial relationships between researchers and medical companies may compromise the safety of human subjects and the integrity of research data.”It has been shown that, for every voting member with a financial conflict of interest, there is a 10 percent greater likelihood of that member favoring the drug in question.
As it turns out, there is a loophole in the financial disclosure regulations. Sponsors have the option of not including financial information if they have “tried and failed to obtain it.” It’s called the “due-diligence exemption.”
Seems this exemption is being made wide use of, as most sponsors said the investigators “could not be located” or failed to return the financial form. An easy way to weasel out of accountability.
Even when financial conflicts of interests were disclosed, the report said that FDA reviewers and sponsors failed to take action to remedy the conflict in 20 percent of the cases. The conflicts were simply “overlooked.”
In its scathing report, the OIG recommended that the FDA:
- Compile a general database of clinical investigators and their financial disclosures in order to more easily look for conflicts of interest for future trials
- Check that sponsors have submitted all required financial forms along with their marketing applications
- Revise/update the “due diligence” exemption
- Require disclosures as part of the pre-trial process, rather than upon its completion
The record of alarming failures by the FDA to protect you is evidence that the FDA is in need of radical restructuring, including an infusion of strong leadership, money, technology and personnel.
Some of the changes that have been recommended are:
These changes will not happen without your help. Please don’t underestimate just how much influence you have.
- An infusion of strong leadership that inspires the public trust, money from independent sources, and new personnel
- New regulatory standards and procedures with better oversight and enforcement
- Better policing of safety standards abroad, boosting inspections
- Updating of agency computer systems, which are archaic
- A return to using science as a basis for decision-making
You can independently call or write to your Congressman and let them know that these failures, double standards and deficiencies are no longer acceptable. Encourage your friends and family to do the same.