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.

Thursday, November 15, 2012

Congressional Hearing on Deadly Meningitis Outbreak Wants Answers from FDA

The Commissioner of the FDA, Dr. Margaret A. Hamburg was called on the carpet at a congressional hearing yesterday after the FDA failed to take action to prevent a deadly meningitis outbreak throughout the country.

NECC (New England Compounding Company) made and distributed batches of a fungal contaminated medicine, which caused numerous deaths and serious illness throughout the country. The FDA had had a troubled past with NECC for over a decade. State agencies from several states had also reported unsafe practices by NECC to the FDA. Yet the FDA New England District office, headed by Capt. Mutahar Shamsi, did nothing to regulate NECC to prevent the manufacturing of tainted medicine which caused the meningitis outbreak.

Congressional members pelted FDA Commissioner Hamburg with questions about FDA's lack of oversight where she appeared evasive in most instances, yet was consistent in parroting for more laws and more money for the FDA due to lack of jurisdiction and resources. The FDA presently receives about 4.5 billion a year through tax payer’s money and user fees. Many congressional members did not buy into Commissioner Hamburg’s line.

What made it even more frustrating for many congressional members was that the FDA had failed to cooperate with congress in providing related internal documents from the FDA New England District, even when the documents had been requested a month earlier. The other red flag was that the FDA was well aware that the company was a manufacturer and not just a standard compounding pharmacy. This fact alone made it difficult for many congressional members to swallow Commissioner Hamburg’s answer that FDA had no jurisdiction over NECC.  Some members of congress believed that the FDA had to have had some form of authority to prevent the release of tainted medicine.  Yet, Hamburg could not address the issue of the FDA's lack of due diligence. Rep Cliff Stearns from Florida, who chaired the congressional hearing, said that someone in the FDA was not watching.

Distribution of the tainted drug has already resulted in 32 deaths and hundreds of serious illnesses. Many more deaths are expected since thousands of patients where exposed to the deadly fungus through injection of the medicine by physicians in at least 23 states.

Congress does well to demand more transparency and accountability to why the FDA failed in oversight and enforcement which led to distribution of an unsafe medicine and tragic deaths throughout the country.

Friday, November 2, 2012

Will New Laws Prevent Future Meningitis Outbreaks?

Legislators Should Examine FDA before Creating New Laws

Today an article from the Wall Street Journal reports that Rep Edward J. Markey (D., Mass) and Rep Rosa De Lauro (D., Conn) plan to introduce a bills that would “give the FDA clearer authority to regulate large pharmacies that mix customize drugs like the one tied to a deadly meningitis outbreak”.

But legislators may be on the wrong track. Prior to the outbreak, the FDA had sufficient jurisdiction to inspect NECC, the compounding pharmacy who manufactured in bulk, injectable medicines that caused the meningitis outbreak.

Mutahar Shamsi, the District Director for the New England FDA Office of Regulatory Affairs, during an October 2012 press conference, however, was quoted as stating that an inspection occurred on October 1st, 2012, only after the outbreak. No other inspectional information on NECC has been released by the FDA depite the fact that this company was on the FDA's inspection list. The big question is why did the FDA fail to perform at least minimal oversight of NECC where they had jurisdiction to do so?

The lack of oversight of NECC by the FDA raises questions to the possibility of either incompetence or conflicts of interests within FDA leadership in the New England Boston district. Conflicts of interests can  undermine enforcement of laws since FDA regulators can pick and choose whom they inspect or regulate.  

Excuses to a lack of jurisdiction or lack of resources are often made to cover up inadequacies, unethical standards or poor leadership within government agencies. 

Making new laws will not protect the public when regulators act in capricious ways to favor industry and are not held accountable to uphold current law.The New England Boston District FDA office needs to be thoroughly examined regarding their prior oversight of NECC or their lack there of. The public should have transparency as to the real reason why the FDA did not properly inspect NECC prior to the meningitis outbreak that caused 28 deaths, when in fact, they had jurisdiction to do so, and when in fact, NECC had a history of prior complaints.

Saturday, April 21, 2012

New Emerging Disease in Vietnam

A new mystery illnes has hit Vietnam causing concern from government officials.  At least 19 people have died and 171 are sickened.  Patients first experience a fever with rashes on their hands and feet.  Organ failure can result leading to death.

Thursday, March 22, 2012

Mystery Illness Attacks Children

Thousands of Children Attacked by Mystery Disease

A crippling mystery illness has attacked thousand of once healthy young children in Uganda. Medical officials throughout the world are perplexed as thousands of children become completely disabled mentally and physically with neurological effects such as seizures and brain disfunction. Some children have even succumb to death.  The children are left unable to cope or maintain normal lives. The illness has placed great hardships upon families and communities. Medical officials are looking into food sources or infectious disease as sources of the problem.  But as epidemic grows, no answers or therapies are currently available.

Tuesday, March 20, 2012

Lab Shuts Down after another Biocontainment Problem

University of Chicago lab closed after infection case

Science News

CHICAGO, Sept. 15 (UPI) -- University of Chicago officials say they've suspended research in a school lab after a scientist contracted an infection from a bacteria being studied there.

The unidentified female scientist was admitted Aug. 27 to the university's medical center with a skin infection from B. cereus, a bacteria that can cause food poisoning, the Chicago Sun-Times reported Thursday.

The infected tissue was removed surgically and after a course of antibiotics she was released, school officials said.

The incident at the Cummings Life Science Center did not pose a risk to the campus or community as the bacteria is not transmitted through the air or from human to human, officials said. But the Centers for Disease Control and Illinois state and local health agencies were notified as a precaution, they said.

"We assessed there was a very small possibility the contaminant had gotten out of the room," said Conrad Gilliam, a dean in the school's biological science division.

"As an added precaution, this particular agent and all others at that biosafety level have been moved off site to Argonne (National Laboratory), pending decontamination and a thorough review of protocol."

Two years ago a U. of C. researcher studying the origins of plague-causing bacteria in a different lab in the same building contracted the disease and died, the Sun-Times reported.

There were significant differences between the two incidents, school officials said.