In the wake of lax workplace standards at a Massachusetts-area compounding pharmacy where contaminated steroid shots led to a deadly meningitis outbreak — resulting in 32 deaths across 19 states so far — the Food and Drug Administration (FDA) has found evidence of gross workplace negligence at another drug-making facility owned by the same people as the outbreak-linked pharmacy.

Ameridose — a Westborough-based compounding company founded by brothers-in-law Barry Cadden and Greg Conigliaro that provides pre-filled compounded medication to hospitals across the country — recently opened its doors to federal regulators for a month-long inspection after the public health crisis spurred by its partner, the New England Compounding Center. The FDA found that Ameridose fell far short of safety, cleanliness, and accountability standards, potentially compromising patient safety around the United States:

Inspectors said they found insects within 10 feet of a supposedly sterile area where drugs were manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.

Elsewhere, the report cites leaks and cracks in the ceiling and walls of a clean room used to manufacture sterile drugs. The same room contained “thick residues that were orange, brown, and green” on equipment used for sterilization.

FDA inspectors also said the company did not investigate at least 53 incidents of bacterial contamination that arose during testing of stock drug solution.

“There is no documented evidence that your firm implemented permanent corrective actions to prevent these sterility events from recurring,” investigators wrote.

Although the FDA has not formally linked Ameridose to any illnesses, and the company asserts that none of its drugs have been outright contaminated, the compounding pharmacy has seen dozens of complaints from hospitals and patients that their medications have not worked as advertised. The FDA’s recent findings raise concerns that lax safety procedures in the largely unregulated compounding pharmacy industry could lead to more public health emergencies and patient deaths.

Earlier this month, Massachusetts approved tighter state regulations on its compounded drug industry, empowering state officials to track the production and distribution of compounded drugs in an effort to prevent the kinds of outbreaks caused by the Massachusetts compounder. Later that week, Rep. Ed Markey (D-MA) introduced federal legislation to grant the FDA similar oversight of the industry.

The Boston Globe reports that Massachusetts’ Question 2 — the so-called “Death With Dignity” initiative that would have permitted terminally-ill patients to request physician-assisted suicide medications — was narrowly rejected by a 51-49 margin.

Question 2 would have allowed Americans with six months left to live to request medication to end their lives, after making their request multiple times and being deemed mentally competent to make the decision. Advocates portrayed it as a means of relief and dignity for ailing Americans. But the proposition’s opponents launched a fierce fundraising campaign against the measure, eventually chipping away at its public support:

The ballot question has been the subject of a ferocious political battle. After a Boston Globe poll in September showed voters overwhelmingly supported the measure, support steadily eroded in the face of a last-minute effort by a diverse group of opponents, including religious leaders, anti-abortion activists, and conservatives who aired their message in aggressive television advertisements and at church services. The concerted opposition campaign, which also included a major physician’s group, raised more than three times as much money as proponents. [...]

Massachusetts would have followed Oregon and Washington, which have passed similar initiatives to allow terminally ill patients to seek life-ending drugs from physicians. Donations to opposition groups, which raised nearly $2.6 million, came from far-flung Catholic dioceses, fueled in part by fear of a domino effect if the measure were to gain a foothold in Massachusetts.

Proponents of the measure raised about $700,000.

Question 2 was closely modeled after similar legislation in Oregon, where records show that a fairly small number of patients request fatal doses of medication and even fewer numbers choose to use them, suggesting that the legislation is not being abused there. But the measure’s critics worried that the language of Massachusett’s ballot initiative was poorly constructed and ethically at odds with the medical profession. Although advocates for the terminally-ill see physician-assisted suicide as a personal choice and fundamental right — and often a way of ensuring patients don’t have to resort to desperate tactics — the issue remains contentious across party coalitions.

Since the recent outbreak of a deadly strain of fungal meningitis was traced to contaminated steroid shots produced in a Massachusetts-area compounded pharmacy, Massachusetts officials have been cracking down on the largely unregulated compounded drug industry. And earlier today, the Massachusetts Board of Registration in Pharmacy approved new, tighter rules for compounding pharmacies that will — for the first time in the state’s history — empower state officials to track compounded drugs and help prevent future public health crises.

The new regulations allow the state to penalize compounding pharmacies whose products fail to comply with safety standards, giving the pharmacy board power to quarantine compounded drugs they suspect to be unsafe — such as the tainted steroid shots, which ended up exposing thousands of Americans to meningitis and killing nearly 30 people — without waiting to hold a hearing first. The Boston Globe reports that Massachusetts’ efforts to tighten regulations in the pharmaceutical industry are also being replicated on a national level, now that the meningitis outbreak has brought more attention to the lack of regulatory power over compounded pharmacies and their potentially dangerous products:

At the same time, Massachusetts Congressman Ed Markey unveiled federal legislation Thursday to address what he called a “regulatory black hole” currently governing these pharmacies by giving the FDA new oversight authority. [...]

“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” interim state public health commissioner Dr. Lauren Smith said in a statement.

The Department of Public Health also announced Thursday that Christian A. Hartman, a specialist in pharmacy practice and patient safety, would chair a new Special Commission that will study potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight.

Over 20,000 U.S. pharmacies across the country practice compounding, which involves repackaging or recombining medications in an attempt to keep down the costs of filling prescriptions. However, despite the widespread practice, the Food and Drug Administration hasn’t been able to oversee this sector of the pharmaceutical industry because it doesn’t have the power to regulate pharmacies — which means that compounded drugs do not have to meet the agency’s safety guidelines. Public health advocates have been calling on Congress to strengthen the FDA’s regulatory power to prevent future outbreaks, and Massachusetts’ new regulations are a step in the right direction to correcting the situation that allowed meningitis to spread in the first place.

A new lawsuit over harmful levels of the coolant polychlorinated biphenyl (PCBs) in Massachusetts school buildings is forcing biotech firm Monsanto Company to revisit its unsavory past. Before Monsanto became the agricultural giant it is today, the company’s major product used to be PCBs, which it routinely dumped in rivers and open pits while deliberately attempting to hide the damage. The company managed to survive the many lawsuits from poisoned communities and distance itself from its toxic past — largely thanks to the help of Mitt Romney.

But now the town of Lexington is trying to hold the company accountable for the PCBs used in school construction between 1950 and 1976, when PCBs were banned by Congress. The lawsuit, which seeks to represent all Massachusetts schools, claims Monsanto should have warned manufacturers of the health and environmental dangers posed by exposure to PCBs. The chemical has been definitively linked to cancer and serious neurological and hormonal disorders.

Monsanto’s corporate affairs director fired back that the company is not responsible for the outdated building: “It is our understanding that the school in question was built over 50 years ago, was poorly maintained, and was scheduled for demolition years ago since it had outlived its useful life.”

Many of the schools in Massachusetts have also “outlived” themselves, partly due to the same man who helped Monsanto outlive its disastrous PCB scandal. As governor, Romney slashed state funds for local aid in 2003 and 2004, forcing towns to cut corners and enact freezes on education spending. As almost half of all municipal revenue goes toward education, Romney’s austerity budgets dealt a serious blow to local schools.

Later, Romney took credit for then Treasurer Tim Cahill’s plan to refinance school building assistance, which was meant to clear the more than 400 pending school construction projects in the state. Soon after the refinancing plan was passed, however, Romney froze state contributions to local school construction projects, leaving cities and towns to scramble for funds and suspend some of their backlogged projects.

Lexington’s lawsuit states that more than half of the state’s 1,900 schools were built between 1950 and the 1970s, making them likely to contain harmfully elevated levels of PCBs.