Monday, March 11, 2013

60 Minutes Biased Reporting on FDA’s Oversight Debacle of NECC

FDA inspects NECC after deaths occur
Last night on March 10, 2013, 60 Minutes presented an improperly slanted report on the NECC (New England Compounding Company) oversight debacle which has currently caused 48 deaths from a release of a fungal-contaminated injectable medicine. The 60 Minutes’ story failed to report on important facts behind FDA’s role within the current regulatory framework which could have prevented this public health disaster.

One statement that Scott Pelley from 60 Minutes incorrectly reported in his story is when he said “It was up to the Massachusetts Board of Pharmacy to inspect NECC”. Pelley claims that a 1998 law prevents the FDA from inspecting compounding pharmacies. This is simply untrue. Unfortunately, 60 Minutes left the audience believing that the main problem with the FDA was a lack of jurisdiction under the federal law to inspect NECC.

Despite 60 Minutes’ erroneously claims that a 1998 law prevents the FDA from inspecting compounding pharmacies, the FDA had indeed inspected many compounding pharmacies after 1998, including NECC. In fact, an inspection of NECC resulted in a FDA Warning Letter in 2006 for unsafe practices and unapproved new drugs. Regrettably, the FDA subsequently failed to follow through with another inspection at NECC after the warning letter.

The fact remains, that the Boston FDA Field Inspection Division, Office of Regulatory Affairs in Massachusetts did have authority to inspect NECC, but failed to enforce jurisdiction, fully knowing that NECC had serious safety problems. Most disturbingly, prior to the release of the fungal-contaminated methyprednisone injectable medicine, the FDA had received several official complaints from various states regarding NECC’s unsafe practices and suspected manufacturing status. These complaints should have automatically mandated an inspection at NECC to assess federal oversight. Yet FDA took no action to inspect NECC after receiving these complaints.

What is odd is that standard procedure dictates that the FDA should have followed up on the 2006 FDA Warning Letter with an additional FDA inspection of NECC, even without the notification of additional complaints against the company. Yet the New England Boston FDA again took no action. The New England FDA district did not even perform the basic FDA enforcement required of them.

Obviously, the FDA had authority and jurisdiction to inspect NECC. In fact with clear authority they could have used the 2006 Warning Letter to perform an inspection at NECC to investigate the additional complaint-driven evidence that they had on hand. And even if the FDA would have somehow still worried about jurisdictional concerns, there were other methods they could have employed to invoke their authority. In fact, the current standard practice within the FDA would have been to request a joint inspection of NECC with the Massachusetts’s Board of Pharmacy to clarify their jurisdiction. Yet, despite all the many notifications of complaints to the FDA and the prior FDA warning letter which warranted an inspection of NECC, the FDA in Boston chose not to inspect NECC when they had every right, jurisdiction, and avenue to do so. Clearly, the FDA New England Boston district failed in accountability to uphold even the basic facets of the law.

Where was Scott Pelley from 60 Minutes on this issue of accountability?

In Pelley’s report last night 60 Minutes avoids any mention toward accountability of the FDA’s wrong-doing within the NECC debacle. Instead of presenting the facts, 60 Minutes gives the audience the false impression that a complete lack of federal laws caused the problem of the lack oversight by the FDA.

Even, given the assumption that stronger federal laws are indeed needed and would benefit efficient regulation of compounding pharmacies in the future, it still gives 60 Minutes no justification not to report on improper oversight within the FDA. Especially in light of the fact, that even working with weak laws, the FDA could have prevented the NECC disaster with an inspection by a qualified inspector. 60 Minutes should have reported the facts instead of slanting the story untruthfully.

The former FDA commissioner, David Kessler, was right when he said “There is no reason that people had to die” because of NECC. The truth is that the NECC oversight debacle involved a complete system break down, involving not only corruption within NECC, but also, included obvious faults of the FDA. It was not a lack of federal jurisdiction that was the main problem as 60 Minutes suggests, but rather, it was the FDA’s lack of action to enforce any oversight of NECC even when obvious public health threats were imminent. This lack of oversight resulted in the release of contaminated medicine causing the deaths of 48 people. It also inflicted a horrendous illness in over 700 hundred people who remain fighting infections from a fungus that attacks their bones, nerves and brains while enduring a painful treatment of no proven cure.

Making new or stronger laws will not protect the public when leadership within the FDA is either incompetent or is corrupted with conflicts of interests. Simply put…laws without the accountability of enforcement just do not work. We must force our government officials to be accountable. Even now, the FDA has not disciplined anyone within the FDA for an obvious lack of duty to inspect NECC.

Conflicts of interests within the ranks of our government can have a devastating impact on public health. We need credible leadership in our agencies to ensure responsible actions that protect the public and enforce laws. Despite the fact that 60 Minutes gave stark reports on the terrible suffering of persons exposed to the fungus-contaminated medicine and on the corruption inside NECC, they failed to take justifiable aim at the lack of government accountability in the NECC case. 60 Minutes should be embarrassed by their biased reporting and obvious omission regarding the irresponsible lack of oversight of NECC by the New England FDA district.

1 comment:

  1. The FDA takes a blind eye when it comes to Big Pharma drug companies, they are aware of the many people hurt and damaged by products, yet they do nothing until there are enough deaths or they are exposed. The FDA make recommendations and never follow up to see if the drug company followed the recommendations. They approve use of drugs, devices and never even investigate any of the adverse affects, yet there is a maude data base where reports are made yet the FDA does nothing. Years of adverse affects reported yet a product called Sculptra prevails!!! They approve a device to be used without even knowing how the product works, ie. the composition, its dilution,its mechanism/ mode of action or how long it lasts in the body, no clinical trials or anything. I am talking about a product called Sculptra, "a poly L lactic acid device", the FDA approved for off label use to be used only in immuno-compromised patients, ie. HIV patients with lipoatrophy, yet the FDA allowed the drug company to market it off label and to inject perfectly healthy men and women with healthy immune systems as a drug, yet the drug company had it approved as an implant/device which they never disclosed to the MD's using this product and who are injecting into the faces, hands etc. and having no idea what response or how the drug/device worked,or how long it lasted, and who are now faced with granulomas, biofilms, endless surgeries trying to get the product out of their bodies, which they cannot!!! disfigurement,chronic inflammation, and pain daily for over 4 years or longer and their immune systems attacked because their bodies are trying to reject this implant/ device and this product doesn't break down in their bodies. The drug company lied to the inspector as to even how long its lasts in the body(any child can google poly L lactic acid and it will tell you five years or longer or unknown), and at that time there were over 764 cases reported having problems yet our FDA continues to allow this company to inject healthy people and knowing in Europe in 1999 there were problems. So I ask you how many people have to be harmed before the FDA will do anything???? The FDA first approved this in 2004 for off label use and expedited a PMA. The drug company marketed this without following the FDA's recommendations. The FDA knew this!! The panel of MD's knew this!! In the FDA 2004 panel they openly admit they were approving this product with their hearts and not with their brains for they had no idea how this product worked!!!SCARY HUH???? Seriously????? The FDA panel was to have a meeting and have the drug company produce data of clinical trials, WHICH WERE NEVER DONE before approving this BUT THEY DID NOT!!!! THE FDA PUT THIS THROUGH KNOWING Problems existed yet granted BIG PHARMA a PMA and usage for on label with the FDA approval!!!!.
    P.S 60 minutes was originally interested in our story?/ suffering, but put in on the back burner no one has died yet, just disfigured and really sick!! Some can no longer work because no one knows how to treat this. No one will help us.
    The government will never take accountability, even when we can prove fraud by the pharmaceutical company and have reported to the department of justice, called the FDA!
    We can only try to get the message out there, so hopefully no one else is harmed and go through this suffering. Thank you