Government

Radiopharmaceutical Manufacturing Proponents Face Questions, Opposition at Forum on Proposed Millburn Operation

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Psnel members listen as AAA executive James Cook explains how the proposed pharmaceutical facility will operate. Credits: Bob Faszczewski
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Residents raise their objections to the proposed facility. Credits: Bob Faszczewski
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MILLBURN, NJ - The chief North American operating officer for Advanced Accelerator Applications (AAA), which has been approved by the township Planning Board for a change in use for a building at 57 Willow St. to allow for manufacture of a cancer fighting drug comprised of radioactive materials, on Thursday held the first of two planned forums at the Millburn Township municipal building regarding the facility. 

The AAA official, James Cook, was joined by a panel of experts and the wife of a patient treated by drugs using the same manufacturing process to fight neuroendocrine tumors of the small bowel.

Although Cook and members of his panel assured those in attendance that the proposed manufacturing operation would be safe because it would involve extremely low doses of radioactive materials, several residents were skeptical of the claims and questioned the location of the proposed facility near an athletic training facility, schools and playgrounds and near residents with small children and a number of pregnant women.

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Township Committee members who spoke at the April 21 governing body session said the committee had no authority over the planning board’s decision-making and the Planning Board only was empowered to approve a change of use of the facility.

The AAA official said the firm “produces life-saving medicine,” and 100,000 people in the United States have the disease, of which those with invasive metastatic cancer currently must go outside the United States for treatment or endanger their lives.

The most notable person in recent history to have the disease was Steve Jobs, Cook said.

He added that Lutetium-177, the isotope used to produce lutathera, the drug used to treat the disease, has a half life of 6.6 days.

Panel member Greg Hisel, radiation safety officer at St. Francis Hospital and Medical Center in Hartford, CT, said in about two and a half months the radiation is undetectable.

Stefano Buono, the founder of AAA, added that the danger is even less because the small amount of radioctive material in the medicine is injected directly into the patient and targets cancerous cells while avoiding adjacent non-cancerous cells.

Cook added that, in the event any of the material is “spilled” inside the isolator in which it is being injected, those administering the drug are moved to the next isolator to work and the facility in which the incident happens is thoroughly cleaned in accordance with Nuclear Regulatory Commission standards.

However, resident Eric Siegel, who is a dermatogist with offices near the proposed AAA facility, asked why the facility should be located in Millburn, close to schools and facilities housing children and in a township whose fire department is not trained to deal with a radiation “hazmat” accident.

Disputing contentions by Buono that there had been no incidents worldwide of injuries or deaths from the use of radiation in similar processes, Siegel cited an incident in Malaysia in 2011 where four workers at a facility involved with radioactive materials manufacturing were found to have been exposed to radioactive material.

He added that Millburn residents were not fighting the existence or usefulness of the drug, but only its manufacture in an area so close to facilities where children are present.

An AAA spokewwoman in the audience at the forum replied that there was virtually no trace of the radiation in the Malaysian workers after about 20 hours.

In addition, panel member Jim Weiveris, president of the New Jersey Carcinoid Cancer NETwork, called the cancer treatment a “magic bullet” because it was more targeted and much safer for patients than chemotherapy.

He added the track record of regulatory agencies in the United States dealing with radiation was much better than those in Malaysia.

Cook added, both for the good of his firm’s patients and the office workers who would be situated in the 60 percent of the Millburn facility not associated with the manufacturing process, he was glad that the facility was so closely monitored by the NRC and the New Jersey Department of Environmental Protection as its agent in the state.

Panelist Bill Diarmantopolus, who recently joined AAA and will be the operations manager for the proposed facility, said he previously had worked in a radiopharmaceutical pharmacy in New York City that was within 200 feet of a charter school and for even the smallest suspicion of an incident his firm had to answer to the NRC and other regulatory officials.

Buono added that, in 12 years of operating facilities in Europe, he had not had a single incident where someone was injured due to the process.

Replying to Siegel’s questions about how quickly the planning board approved the AAA application—after only two hearings—AAA attorney Steve Miarella said proper notification had been given to all property owners within 200 yards of the facility and the planning board only had to approve the change in use and the addition of parking spaces on the site because the previous use had included only offsite parking.

If the facility were large enough to accommodate an expansion in the future, he added, any such proposal would have to be examined by the township zoning officer and construction official before again coming before the local planning or zoning boards.

Buono also indicated that, logistically and economically, his firm could not expand the proposed facllity within the next five years.

Another resident said the facility should be located in an industrial park where it was not near children.

She also quoted an internet article on the Malaysia incident which, she said, indicated that radiation levels following the accident were more than 400 times the normal safe limit.

Cook noted, however, that some of the reasons the company chose Millburn were that the building was just the right size for its operation, the site was close to a train station and it was within walking distance of Millburn’s excellent shopping district.

Marilyn Labendz, whose husband Ralph had to go to Israel for the treatment, said it only involved 30 minutes of injections in a lead-lined room from which he was released after 24 hours.

She added that her husband had been reluctant at first to play with his young grandchildren after the treatment but found he had nothing to fear in that regard.

Labendz added that if the treatment was allowed in the United States patients might be able to have it covered by Medicare and patients would not have to go through their life savings to pay for it.

A township resident who works in the pharmaceutical industry said some of his co-workers who were familiar with the process said the radiation exposure was no greater than that in most homes.

An answer sheet handed out at Thursday’s session said the maximum exposure level allowable by the New Jersey DEP for exposure to Lu-177 radiation used in the manufacture of the medicine in the proposed Millburn facility was equivalent to the radiation received by:

  • Half of the average annual exposure to home radon gas
  • Two and a half sets of dental x-rays
  • 10 trans-Atlantic flights or
  • One tenth of an average CT scan.

Residents replied however, that they did not wish to be exposed to more radiation than they already had in their daily lives.

Gerri Silverman asked how the process compared to exposure to family members who previously had “radiation seed” therapy for other types of cancers.

Buono replied that the exposure level was roughly equivalent, but, since the process he advocated involved injection of the radiation internally there was less risk of exposure to other people.

Panelists also said the NRC required audits of safety measures while the facility was being completed and audits every year after that.

Cook also said the small amount of radioactive material left after the manufacturing process was completed would be disposed of separate from other waste and any workers accidentally exposed to radioactive materials would be required to remove and dispose of all their clothes and take decontamination showers with plumbing separated from other plumbing in the site.

 

 

 

 

 

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