"Framingham pharmacy is suspected in meningitis deaths" by Carolyn Y. Johnson and Kay Lazar | Globe Staff, October 03, 2012
State and federal health officials have identified a Framingham pharmacy as the source of injectable steroids that may have infected more than 25 people, four fatally, with a rare form of fungal meningitis.
The Massachusetts Department of Public Health released a statement Wednesday night saying the agency is collaborating with the FDA, the US Centers for Disease Control and Prevention, and public health officials in other states to identify the cause of the three-month-old outbreak of aspergillus meningitis that has sickened people in Florida, Maryland, North Carolina, Tennessee, and Virginia....
--more--"
"Meningitis outbreak widens; Mass. company suspected" by Liz Kowalczyk, Kay Lazar and Carolyn Y. Johnson | Globe Staff, October 04, 2012
Federal health officials said Thursday that they found a vial of an injectable steroid contaminated with fungus at a Framingham pharmacy, strengthening suspicions that it is the source of a widening nationwide outbreak of a rare meningitis that has infected dozens of people.
The discovery led the government to expand a recall of the steroid to include all injectable spinal drugs made by New England Compounding Center and to urge health care providers across the country to immediately discard all products from the company out of “an abundance of caution.’’
The hardest hit state so far is Tennessee, where officials said Thursday afternoon that they had identified seven new cases in the previous 24 hours, bringing the total there to 25 people infected. Three have died....
That's enough to make the babies cry.
--more--"
"13,000 may be at risk of meningitis; Patients in 23 states given steroid from Mass. that is tied to outbreak" by Kathy McCabe | Globe Staff, October 09, 2012
US health officials said Monday that 13,000 patients in 23 states, including Connecticut, New Hampshire, and Rhode Island, have been injected with a potentially tainted steroid treatment made by a Framingham pharmacy and linked to a national outbreak of meningitis.
The US Centers for Disease Control and Prevention gave its sweeping estimate of the reach of the crisis as it reported 14 new cases of the disease, and another death in Tennessee, which appears to be the hardest hit among the states where the rare and serious form of fungal meningitis has been confirmed....
--more--"
Also see:
Supervision of pharmacies is questioned
Framingham pharmacy recalls all its drugs
Doctors split on value of low-back injections
14,000 at risk from tainted steroids
Where were the state and federal regulators?
Framingham pharmacy hit with lawsuit
N.H. reports 4 meningitis cases
A close look at compounding pharmacies
Fungal infection strikes 4 in New Hampshire
"FDA widens meningitis infection warning; More drugs made by Framingham firm are called suspect" by Kay Lazar and Liz Kowalczyk | Globe Staff, October 15, 2012
Federal drug regulators warned Monday that more medications made at a troubled Framingham compounding pharmacy may be linked to fungal infections, including a second steroid and a heart drug given to transplant patients.
The disclosures raise the possibility that suspected contamination at New England Compounding Center may affect even more patients than the 14,000 nationwide previously estimated to be at risk.
Investigators descended on New England Compounding earlier this month after dozens of patients began falling ill with a rare fungal infection following injections of the steroid methylprednisolone acetate. So far, 15 deaths and 214 illnesses have been associated with the drug.
The latest concerns involve a steroid medication, triamcinolone acetonide, that is typically given by injection to patients with chronic back pain and a medication used during heart surgery....
Monday’s announcement of another potentially contaminated medication underscores the urgent need for a criminal probe of New England Compounding, said Senator Richard Blumenthal, a Connecticut Democrat and member of a Senate Health Oversight Committee.
Blumenthal sent a letter last week to US Attorney General Eric Holder urging a criminal probe.
Against a pharmaceutical? That's as likely as one against a bank.
“What’s been reported so far about this company is absolutely outrageous,” Blumenthal said in an interview Monday.
Against a pharmaceutical? That's as likely as one against a bank.
“What’s been reported so far about this company is absolutely outrageous,” Blumenthal said in an interview Monday.
“These additional reports simply add to the sense of astonishment that public health could be so seriously endangered by lack of oversight and scrutiny.”
I wish I could say I was astonished; however, the fact is your food, water, and drug supply are seriously compromised.
I wish I could say I was astonished; however, the fact is your food, water, and drug supply are seriously compromised.
"Some patients with severe cases will be on intravenous drugs for months. No one knows the optimal length of therapy because fungal meningitis is so rare, doctors said. “The burden of treatment is unclear; therapy could go on for years,’’ said Dr. James P. Rathmell, chief of pain medicine at Massachusetts General Hospital, who earlier this week was on a panel in Washington, D.C., discussing the outbreak. Doctors “just don’t know, because this is a new phenomenon,’’ he said."
FDA searches pharmacy amid outbreak investigation
Does the FDA involvement make you feel better? Really?
FDA publishes, then pulls list of 75 providers that got drugs
Still think they are looking out for you?
Does the FDA involvement make you feel better? Really?
FDA publishes, then pulls list of 75 providers that got drugs
Still think they are looking out for you?
It was an Amerikan $ucce$$ story.... until:
"Fungal contamination found in medication vials from the Framingham pharmacy at the heart of the national meningitis outbreak matches the type of fungus making most people sick, federal health officials said Thursday, a finding that one infectious disease specialist labeled a “smoking gun.”
"Fungal contamination found in medication vials from the Framingham pharmacy at the heart of the national meningitis outbreak matches the type of fungus making most people sick, federal health officials said Thursday, a finding that one infectious disease specialist labeled a “smoking gun.”
And what does that mean in the business world?
Bankruptcy expected for firm linked to outbreak
Well, there won't be any reparations or restitution money there.
And a$ always, a day late comes the state:
"State to review pharmacy monitoring; Pharmacy’s monitor faced fraud charges" by Liz Kowalczyk and Kay Lazar | Globe Staff, October 23, 2012
Bankruptcy expected for firm linked to outbreak
Well, there won't be any reparations or restitution money there.
And a$ always, a day late comes the state:
"State to review pharmacy monitoring; Pharmacy’s monitor faced fraud charges" by Liz Kowalczyk and Kay Lazar | Globe Staff, October 23, 2012
In 2006, Massachusetts regulators responded to complaints about the New England Compounding Center by enlisting an Illinois firm to review the operations of the pharmacy now at the center of the national meningitis outbreak. The chief executive of that firm, the Globe has learned, was awaiting trial on a fraud indictment.
Pharmacy Support Inc., founded by Ross A. Caputo, inspected the Framingham facility and eventually found it to be satisfactory, helping it avoid probation by the state pharmacy board. Caputo was later convicted and imprisoned for fraud, involving a product blamed for blinding people.
A spokesman for Governor Deval Patrick said in a statement Monday that his administration is investigating regulators’ “troubling” choice of PSI, a selection he said was made during Governor Mitt Romney’s administration.
Yeah, blame the last guy for a problem that has been going on for over 6 years.
Also on Monday....
--more--"
Related: State faults pharmacy on sterility, testing
"Mass. board was lenient on drug maker; Took harsh steps with many other pharmacists" by Todd Wallack and Kay Lazar | Globe Staff, October 25, 2012
Pharmacy Support Inc., founded by Ross A. Caputo, inspected the Framingham facility and eventually found it to be satisfactory, helping it avoid probation by the state pharmacy board. Caputo was later convicted and imprisoned for fraud, involving a product blamed for blinding people.
A spokesman for Governor Deval Patrick said in a statement Monday that his administration is investigating regulators’ “troubling” choice of PSI, a selection he said was made during Governor Mitt Romney’s administration.
Yeah, blame the last guy for a problem that has been going on for over 6 years.
Also on Monday....
--more--"
Related: State faults pharmacy on sterility, testing
"Mass. board was lenient on drug maker; Took harsh steps with many other pharmacists" by Todd Wallack and Kay Lazar | Globe Staff, October 25, 2012
Massachusetts regulators have yanked the licenses of scores of pharmacists in recent years, according to a Globe analysis of national disciplinary data, giving them a track record not out of line with other states, even as they repeatedly failed to discipline the Framingham compounding pharmacy now blamed for a deadly US outbreak of fungal meningitis.
The Massachusetts Board of Registration in Pharmacy revoked or suspended the licenses of 138 of the more than 11,000 licensed pharmacists in the state during the six years preceding June 2011. That is more than many other states, according to data collected by the National Association of Boards of Pharmacy.
Overall, Massachusetts ranked in the middle of states in terms of the number of such actions it took per 1,000 pharmacists during that period, though some years it ranked higher or lower.
A review of how the board compares with its counterparts nationally also shows that it is significantly less transparent, failing to provide on its website the most basic information about its members and does not routinely announce board discipline and other actions. It does not produce an annual report as do many other states.
But, but, but.... this is liberal, Democrat Massachusetts (sob)!
It also failed, until this week, to conduct unannounced inspections, something at least 10 other states have routinely done. But many of the board’s regulations are similar to those in other states, requiring pharmacies to comply with industry safety standards....
I thought that was something only business-friendly Republican administrations did. WTF?
--more--"
"‘High risk’ drug making is at center of meningitis inquiry" by Liz Kowalczyk | Globe Staff, October 26, 2012
The Massachusetts Board of Registration in Pharmacy revoked or suspended the licenses of 138 of the more than 11,000 licensed pharmacists in the state during the six years preceding June 2011. That is more than many other states, according to data collected by the National Association of Boards of Pharmacy.
Overall, Massachusetts ranked in the middle of states in terms of the number of such actions it took per 1,000 pharmacists during that period, though some years it ranked higher or lower.
A review of how the board compares with its counterparts nationally also shows that it is significantly less transparent, failing to provide on its website the most basic information about its members and does not routinely announce board discipline and other actions. It does not produce an annual report as do many other states.
But, but, but.... this is liberal, Democrat Massachusetts (sob)!
It also failed, until this week, to conduct unannounced inspections, something at least 10 other states have routinely done. But many of the board’s regulations are similar to those in other states, requiring pharmacies to comply with industry safety standards....
I thought that was something only business-friendly Republican administrations did. WTF?
--more--"
"‘High risk’ drug making is at center of meningitis inquiry" by Liz Kowalczyk | Globe Staff, October 26, 2012
Inside its sprawling red brick offices, New England Compounding Center engaged in the most hazardous type of pharmacy drug making. The company bought unsterilized powders and turned them into liquid steroids and other medicine supposedly pristine enough to inject into a patient.
It’s called “high-risk compounding,” and doing this safely, industry specialists say, requires elaborate and expensive manufacturing processes, sensitive tests for sterility and potency, and exacting attention to detail.
At the center of the federal and state investigation into New England Compounding, whose steroids were contaminated with a fungus that led to an outbreak of meningitis that has killed 24 people nationally, is whether the company violated these procedures.
We slowly see the death toll rising.
Injectable drugs made from raw ingredients are so susceptible to contamination that in 2009 the Food and Drug Administration highlighted them on a list of medicines that are especially risky for pharmacies to prepare.
The agency offered that list as “guidance to industry,’’ but did not have authority to enforce rules to ensure that pharmacies follow proper practices, FDA spokesman Steven Immergut said last week.
Andrew Paven, a spokesman for New England Compounding, said the company did make drugs from bulk raw materials, but that the approach is typical of the compounding industry.
That can't be good news for anyone who needs these things.
Findings released Tuesday by the state Department of Public Health show that the company ignored state regulations requiring sterility testing for these medicines to be completed before sending them to doctors and patients. On 13 occasions, New England Compounding shipped vials of methylprednisolone acetate from two of the three contaminated lots prior to receiving test results on samples, in one case mailing the drug almost two weeks before results came in.
I don't know, but that looks criminal to me.
The pharmacy’s records show that test results for the steroid eventually showed no contamination, which the Public Health Department said raises questions about the adequacy of the testing....
Of course, they wouldn't falsify records or anything.
--more--"
Related: Patrick appoints interim head of health agency
The horse is already out of the barn!
"Unsanitary practices at pharmacy blamed in meningitis outbreak" by Liz Kowalczyk and Kay Lazar | Globe Staff, October 26, 2012
It’s called “high-risk compounding,” and doing this safely, industry specialists say, requires elaborate and expensive manufacturing processes, sensitive tests for sterility and potency, and exacting attention to detail.
At the center of the federal and state investigation into New England Compounding, whose steroids were contaminated with a fungus that led to an outbreak of meningitis that has killed 24 people nationally, is whether the company violated these procedures.
We slowly see the death toll rising.
Injectable drugs made from raw ingredients are so susceptible to contamination that in 2009 the Food and Drug Administration highlighted them on a list of medicines that are especially risky for pharmacies to prepare.
The agency offered that list as “guidance to industry,’’ but did not have authority to enforce rules to ensure that pharmacies follow proper practices, FDA spokesman Steven Immergut said last week.
Andrew Paven, a spokesman for New England Compounding, said the company did make drugs from bulk raw materials, but that the approach is typical of the compounding industry.
That can't be good news for anyone who needs these things.
Findings released Tuesday by the state Department of Public Health show that the company ignored state regulations requiring sterility testing for these medicines to be completed before sending them to doctors and patients. On 13 occasions, New England Compounding shipped vials of methylprednisolone acetate from two of the three contaminated lots prior to receiving test results on samples, in one case mailing the drug almost two weeks before results came in.
I don't know, but that looks criminal to me.
The pharmacy’s records show that test results for the steroid eventually showed no contamination, which the Public Health Department said raises questions about the adequacy of the testing....
Of course, they wouldn't falsify records or anything.
--more--"
Related: Patrick appoints interim head of health agency
The horse is already out of the barn!
"Unsanitary practices at pharmacy blamed in meningitis outbreak" by Liz Kowalczyk and Kay Lazar | Globe Staff, October 26, 2012
Federal investigators found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’
An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection, according to a report released Friday by the US Food and Drug Administration that depicts a plant where safety practices were lax and contaminants widespread.
But you can trust Amerika's supply chain, folks.
Agency investigators visited New England Compounding Center over seven days this month, after the steroid was recalled by the company.
Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25....
I can't imagine already being in pain or sick and then being poisoned. All for a f***ing buck.
The contaminated steroids from the Massachusetts pharmacy have infected 338 people — 331 with meningitis and 7 with joint infections, the Centers for Disease Control and Prevention said Friday. Another death was reported in Tennessee, bringing the total to 25....
Let's see how many precious and unique souls this thing ends up claiming.
--more--"
I don't need to imagine:
"At hospitals scattered across the country, it was the horror story of the waning days of summer. Teams of physicians faced the same medical mystery — patients with life-threatening infections with an unknown cause. There were subtle hints that they were dealing with a highly unusual illness, and astute clinicians and state and federal health officials worked to connect the dots. Ultimately, they would discover that these seemingly isolated cases were the leading edge of an outbreak of a fungal meningitis so rare that many doctors will never see a case in their lifetimes.
An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection, according to a report released Friday by the US Food and Drug Administration that depicts a plant where safety practices were lax and contaminants widespread.
But you can trust Amerika's supply chain, folks.
Agency investigators visited New England Compounding Center over seven days this month, after the steroid was recalled by the company.
Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25....
I can't imagine already being in pain or sick and then being poisoned. All for a f***ing buck.
The contaminated steroids from the Massachusetts pharmacy have infected 338 people — 331 with meningitis and 7 with joint infections, the Centers for Disease Control and Prevention said Friday. Another death was reported in Tennessee, bringing the total to 25....
Let's see how many precious and unique souls this thing ends up claiming.
--more--"
I don't need to imagine:
"At hospitals scattered across the country, it was the horror story of the waning days of summer. Teams of physicians faced the same medical mystery — patients with life-threatening infections with an unknown cause. There were subtle hints that they were dealing with a highly unusual illness, and astute clinicians and state and federal health officials worked to connect the dots. Ultimately, they would discover that these seemingly isolated cases were the leading edge of an outbreak of a fungal meningitis so rare that many doctors will never see a case in their lifetimes.
The cases would quickly be linked to three batches of an injected steroid produced by a Framingham compounding pharmacy, but by that time 14,000 people in 23 states had received the injections for back and joint pain. More than 300 have fallen ill, and 25 have died."
State wants pharmacist to resign as a regulator
What took so long?
Markey pushes for new pharmacy regulations
Makes him look butch for the Senate campaign.
Drug-mix industry stymies regulators
Imagine my $chock.
"Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.... Pharmacy and laboratory safety consultants said New England Compounding’s report card, sent to the Globe from a hospital that bought from the pharmacy, directly contradicts the findings of the company’s internal testing.... “Their marketing material is baloney.”
I can think of another metaphor, but that will do.
"Prodded by FDA, Westborough firm to recall all its drugs" by Liz Kowalczyk, Kay Lazar and Todd Wallack | Globe Staff, October 31, 2012
Imagine my $chock.
"Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.... Pharmacy and laboratory safety consultants said New England Compounding’s report card, sent to the Globe from a hospital that bought from the pharmacy, directly contradicts the findings of the company’s internal testing.... “Their marketing material is baloney.”
I can think of another metaphor, but that will do.
"Prodded by FDA, Westborough firm to recall all its drugs" by Liz Kowalczyk, Kay Lazar and Todd Wallack | Globe Staff, October 31, 2012
Ameridose LLC, the sister company of the Framingham specialty pharmacy blamed for the deadly outbreak of fungal meningitis in 19 states, agreed to recall all its drugs Wednesday after federal regulators raised questions about the company’s safety tests.
The Westborough company supplies more than 3,000 hospitals nationwide, and several health officials warned that the recall could worsen shortages of some injectable drugs, including ones used during surgery and to resuscitate patients. Some hospitals are discussing the possibility of delaying operations....
So don't get sick.
So don't get sick.
--more--"
"Pharmacy board adopts new rules" by Kay Lazar, Carolyn Y. Johnson and Liz Kowalczyk | Globe Staff, November 01, 2012
Specialty pharmacies similar to the Framingham compounding company linked to the national fungal meningitis outbreak will be required to report to the state the volume of medications they are making and whether they have detected contamination in their laboratories, under emergency state regulations adopted Thursday.
Later in the day, federal regulators said they found contamination in two more New England Compounding Center products — preservative-free betamethasone, a steroid used to ease back pain, and cardioplegia solution, a medication used in heart surgery.
A fungus previously found in another steroid the company makes, preservative-free methylprednisolone acetate, is believed to have infected 386 patients with meningitis and joint infections and killed 28....
--more--"
"Compounding pharmacies fill important medical niche" by Carolyn Y. Johnson | Globe Staff, November 03, 2012
Among the many surprises that have emerged since a Framingham pharmacy was implicated in a national fungal meningitis outbreak is this one: Hundreds of US hospitals, including most of those in Massachusetts, bought medications from the lightly regulated New England Compounding Center.
Unlike major drug manufacturers, the specialty pharmacy was not regularly inspected or monitored by the Food and Drug Administration, yet prestigious hospitals from Massachusetts General to Yale-New Haven were among its customers, according to a list posted online by the FDA.
Hospitals and pharmacists say companies such as New England Compounding play a critical role in supplying scarce drugs, specialized medications, and individually packaged doses. But over the years, some companies have grown so large that they quietly crossed a line, acting more like drug manufacturers than pharmacies that prepare drugs for individual patients....
They are like a bank.
--more--"
Yeah, so stop complaining and take the $hot.
Unlike major drug manufacturers, the specialty pharmacy was not regularly inspected or monitored by the Food and Drug Administration, yet prestigious hospitals from Massachusetts General to Yale-New Haven were among its customers, according to a list posted online by the FDA.
Hospitals and pharmacists say companies such as New England Compounding play a critical role in supplying scarce drugs, specialized medications, and individually packaged doses. But over the years, some companies have grown so large that they quietly crossed a line, acting more like drug manufacturers than pharmacies that prepare drugs for individual patients....
They are like a bank.
--more--"
Yeah, so stop complaining and take the $hot.
Ameridose laying off 650 of staff
But the economy is great!
"Owner of Framingham drug firm faulted; US House panel cites a lack of cooperation" by Liz Kowalczyk | Globe Staff, November 13, 2012
But the economy is great!
"Owner of Framingham drug firm faulted; US House panel cites a lack of cooperation" by Liz Kowalczyk | Globe Staff, November 13, 2012
Pharmacist Barry Cadden, co-owner of the Framingham pharmacy blamed for the deadly national meningitis outbreak, has a long history of not cooperating with federal regulators, including one 2004 inspection when he initially denied having an eye medication that was the subject of a complaint, according to a memo released Monday by a congressional committee....
But he filled an important niche.
But he filled an important niche.
They raise questions about why the Massachusetts pharmacy board did not take stronger action against New England Compounding Center, despite having investigated 12 complaints about the company’s practices over a decade and receiving a 2003 warning from the FDA that the pharmacy’s practices could cause “serious public health consequences’’ and should be curtailed.
I can hazard a few gue$$es.
Staffers of the Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce also questioned why the FDA itself did not take enforcement action against the pharmacy....
I can hazard a few gue$$es.
Staffers of the Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce also questioned why the FDA itself did not take enforcement action against the pharmacy....
So far, the crisis has sickened 438 people and killed 32 who contracted a rare form of fungal meningitis from a contaminated steroid made by the pharmacy. The committee has subpoenaed Cadden to testify because he indicated he would not appear voluntarily....
What's that, a couple a week still dying? Can you imagine the hurt and confusion of family members and those that love them?
In a foreshadowing of the current outbreak, the FDA concluded a meeting with state officials on Feb. 5, 2003, by “emphasizing the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.”
Potential? I'd say they were here, wouldn't you?
What's that, a couple a week still dying? Can you imagine the hurt and confusion of family members and those that love them?
In a foreshadowing of the current outbreak, the FDA concluded a meeting with state officials on Feb. 5, 2003, by “emphasizing the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.”
Potential? I'd say they were here, wouldn't you?
***************************
Officials from the Centers for Disease Control and Prevention said they do not know when the outbreak will abate....
"Vermin, insufficient testing found in Ameridose inspection" by Carolyn Y. Johnson | Globe Staff, November 12, 2012
In a report released Monday afternoon, federal inspectors detailed 15 problems found at major hospital drug supplier Ameridose LLC, ranging from insufficient testing of the sterility and potency of the drugs it made to the presence of vermin in an area where sterile products were packaged and stored....
Ameridose, based in Westborough, is a sister company of New England Compounding Center, where contaminated batches of an injectable steroid have been linked to fungal infections that have sickened more than 400 people and killed 32....
--more--"
"State was lax on Framingham drug maker; Files show ties in oversight, writing of rules" by Kay Lazar and Liz Kowalczyk | Globe Staff, November 14, 2012
State pharmacy regulators on at least two occasions in the past decade displayed indifference in their oversight of a troubled Framingham specialty pharmacy that has now been blamed for a national fungal meningitis outbreak, according to documents obtained by the Globe Tuesday.
Raising the question of why we even have government. It's to advance the agenda of money and corporate interests while padding your pension and salary. That's what it looks like.
At the same time state and federal regulators were investigating New England Compounding Center for problems with sterile drug preparation, the company’s lead pharmacist, Barry Cadden, was chosen to serve on a state pharmacy board task force to write new rules for compounding pharmacies....
Sort of like the fox writing the guard rules for the henhouse.
Raising the question of why we even have government. It's to advance the agenda of money and corporate interests while padding your pension and salary. That's what it looks like.
At the same time state and federal regulators were investigating New England Compounding Center for problems with sterile drug preparation, the company’s lead pharmacist, Barry Cadden, was chosen to serve on a state pharmacy board task force to write new rules for compounding pharmacies....
Sort of like the fox writing the guard rules for the henhouse.
--more--"
So what does the cad have to say for himself?
"Co-owner of pharmacy blamed for outbreak stays silent at hearing" by Liz Kowalczyk and Kay Lazar | Globe Staff, November 15, 2012
WASHINGTON — The co-owner of the Framingham pharmacy blamed for the fungal meningitis outbreak that has killed 32 people strode grimly into a congressional hearing Wednesday overflowing with politicians, patient advocates, and media awaiting an explanation for one of the worst public health crises in decades.
But Barry Cadden immediately made clear he would provide no answers in his first public appearance since New England Compounding Center was tied to the illnesses. “Mr. Chairman, on the advice of counsel, I respectfully decline to answer,” he said repeatedly in response to questions, exercising his constitutional right not to incriminate himself. Cadden appeared to be reading from an index card.
Ever notice the Constitution only seems to protect the criminals these days?
The four-hour hearing was marked by sharp confrontations between members of the House Energy and Commerce subcommittee on Oversight and Investigations and the Food and Drug Administration commissioner, Dr. Margaret Hamburg. Many of the House members said their constituents included some of the 461 people sickened in the outbreak.
It was a political show fooley, folks. Congress does it all the time. A problem comes up, they hold hearings, do a lot of bluster, and then that's that.
Hamburg insisted that her agency did not have the authority it needed to properly oversee compounding pharmacies, which are supposed to custom-make drugs for patients who cannot use manufactured medications. That is why New England Compounding was able to keep making drugs, she said, despite a dozen complaints about its practices and several investigations by FDA and state officials dating to 1999. Several Republican committee members disputed her assertions, saying the agency simply chose not to act.
Does that excuse the state?
Democrats said they want to pass legislation by the end of the year authorizing the FDA to inspect compounding pharmacies and obtain their records. Republicans said they are open to giving the agency more authority — if the FDA proves it needs it by providing hundreds of internal e-mails discussing its dealings with New England Compounding, which the agency so far has failed to do.
At a separate hearing at the State House in Boston on Wednesday, Massachusetts lawmakers grilled public health administrators about their oversight of compounding pharmacies, saying more accountability and transparency are needed.
“The public needs to be reassured . . . that if they are receiving pharmaceuticals, that they are safe, and they won’t become sicker by the drugs they are receiving,” said Representative Harold Naughton, chairman of the Joint Committee on Public Safety and Homeland Security.
News bulletin for you: We are not, and after this will not be soon.
State Health and Human Services Secretary Dr. JudyAnn Bigby testified that the Patrick administration would be scrutinizing the structure of state boards that oversee health professions. The pharmacy board is made up primarily of pharmacists, including seven of the current 10 members. There is one vacancy.
“While it is important that professional expertise be represented, there needs to be a better balance of oversight to include members who are free of conflict,” Bigby said....
Bigby, the health secretary, told Massachusetts lawmakers that more money is needed to adequately monitor the state’s compounding pharmacies. The state health department has shouldered steep budget cuts in recent years.
This in a time of austerity.
“If there were more resources, it would be possible to do more unannounced inspections,” Bigby said, referring to the five additional inspectors the agency recently hired temporarily to conduct surprise inspections of the state’s 25 compounding pharmacies that produce sterile injectable medicines similar to the now-closed New England Compounding Center.
If the agency needs more money, David Linsky, chairman of the House Committee on Post Audit and Oversight, told her, “get us a request for more resources.”
Why should we need them when the medical companies are truly only looking out for our health? Or are they looking out for $omething else entirely?
*******************************************
In Washington, Joyce Lovelace of Kentucky told lawmakers that New England Compounding killed her husband, Judge Eddie Lovelace, one of the first patients to die in the outbreak. He got injections of the pharmacy’s contaminated steroid for back pain resulting from a car accident. Weeks later, he died of a stroke. “Why did so many medical providers purchase this product from unregulated or poorly regulated sources,” Joyce Lovelace asked from a wheelchair.
I hold them responsible.
Cadden then came in, under a subpoena to appear. His attorney, Bruce Singal of Boston, had delivered a letter to subcommittee members explaining that Cadden had “strong desires’’ to answer the committee’s questions, but given state and federal investigations, Singal had advised him to exercise his Fifth Amendment privilege. He said Cadden had cooperated with investigators to quickly recall 17,676 doses of the contaminated steroid so no one else would get sick.
After Cadden was seated, Representative Clifford Stearns, a Florida Republican and committee chairman, said the loved ones of those who died and patients who are sick “deserve some answers today. Mr. Cadden, I ask you to reconsider and tell this committee how this tragedy happened.’’
Cadden, who was also chief pharmacist of New England Compounding, declined. Stearns and Representative Diana DeGette, a Colorado Democrat, tried to prod Cadden into answering questions, but eventually Stearns dismissed him. As Cadden walked outside, he was followed for two blocks by television crews shouting questions. He looked straight ahead and did not say a word, before getting into a waiting black sport utility vehicle.
Afterward, Representative Edward Markey, a Massachusetts Democrat, said he was “very disappointed. This was his opportunity to explain to the American people.’’ But Markey added, “He is going to be charged with very serious violations of law, so I understand why he pled the Fifth.’’
Is he?
When her turn came, Hamburg called federal and state regulations of compounding pharmacies a “crazy quilt’’ of confusing rules. She said the FDA can routinely inspect and demand documents from manufacturers, but not from compounders. But committee members said New England Compounding was acting as a manufacturer, shipping thousands of doses to dozens of states, and the agency could have stepped in.
They pointed to a 2006 warning letter from the FDA, which threatened New England Compounding with “seizure or injunction” if it did not improve its practices.
“Are you saying that letter was an empty threat?’’ Stearns asked.
Yup.
Congressional investigators were also highly critical of the Massachusetts pharmacy board. “It seems to me the ball was dropped and dropped in a big way,’’ DeGette said.
Dr. Lauren Smith, interim commissioner of the state Department of Public Health, who also testified before the committee, agreed. “There were certainly missed opportunities and lapses of judgment,’’ she said.
Representative Janice Schakowsky, an Illinois Democrat, asked whether the board failed to take strict action against New England Compounding, including weakening a 2006 consent agreement with the company, because it was too close to the pharmacy. Board member Sophia Pasedis worked for New England Compounding and later for its sister company Ameridose. The state has since asked her to resign from the board.
“It seems like the board was more interested in protecting pharmacists than in protecting consumers,’’ Schakowsky said....
--more--"
So what does the cad have to say for himself?
"Co-owner of pharmacy blamed for outbreak stays silent at hearing" by Liz Kowalczyk and Kay Lazar | Globe Staff, November 15, 2012
WASHINGTON — The co-owner of the Framingham pharmacy blamed for the fungal meningitis outbreak that has killed 32 people strode grimly into a congressional hearing Wednesday overflowing with politicians, patient advocates, and media awaiting an explanation for one of the worst public health crises in decades.
But Barry Cadden immediately made clear he would provide no answers in his first public appearance since New England Compounding Center was tied to the illnesses. “Mr. Chairman, on the advice of counsel, I respectfully decline to answer,” he said repeatedly in response to questions, exercising his constitutional right not to incriminate himself. Cadden appeared to be reading from an index card.
Ever notice the Constitution only seems to protect the criminals these days?
The four-hour hearing was marked by sharp confrontations between members of the House Energy and Commerce subcommittee on Oversight and Investigations and the Food and Drug Administration commissioner, Dr. Margaret Hamburg. Many of the House members said their constituents included some of the 461 people sickened in the outbreak.
It was a political show fooley, folks. Congress does it all the time. A problem comes up, they hold hearings, do a lot of bluster, and then that's that.
Hamburg insisted that her agency did not have the authority it needed to properly oversee compounding pharmacies, which are supposed to custom-make drugs for patients who cannot use manufactured medications. That is why New England Compounding was able to keep making drugs, she said, despite a dozen complaints about its practices and several investigations by FDA and state officials dating to 1999. Several Republican committee members disputed her assertions, saying the agency simply chose not to act.
Does that excuse the state?
Democrats said they want to pass legislation by the end of the year authorizing the FDA to inspect compounding pharmacies and obtain their records. Republicans said they are open to giving the agency more authority — if the FDA proves it needs it by providing hundreds of internal e-mails discussing its dealings with New England Compounding, which the agency so far has failed to do.
At a separate hearing at the State House in Boston on Wednesday, Massachusetts lawmakers grilled public health administrators about their oversight of compounding pharmacies, saying more accountability and transparency are needed.
“The public needs to be reassured . . . that if they are receiving pharmaceuticals, that they are safe, and they won’t become sicker by the drugs they are receiving,” said Representative Harold Naughton, chairman of the Joint Committee on Public Safety and Homeland Security.
News bulletin for you: We are not, and after this will not be soon.
State Health and Human Services Secretary Dr. JudyAnn Bigby testified that the Patrick administration would be scrutinizing the structure of state boards that oversee health professions. The pharmacy board is made up primarily of pharmacists, including seven of the current 10 members. There is one vacancy.
“While it is important that professional expertise be represented, there needs to be a better balance of oversight to include members who are free of conflict,” Bigby said....
Bigby, the health secretary, told Massachusetts lawmakers that more money is needed to adequately monitor the state’s compounding pharmacies. The state health department has shouldered steep budget cuts in recent years.
This in a time of austerity.
“If there were more resources, it would be possible to do more unannounced inspections,” Bigby said, referring to the five additional inspectors the agency recently hired temporarily to conduct surprise inspections of the state’s 25 compounding pharmacies that produce sterile injectable medicines similar to the now-closed New England Compounding Center.
If the agency needs more money, David Linsky, chairman of the House Committee on Post Audit and Oversight, told her, “get us a request for more resources.”
Why should we need them when the medical companies are truly only looking out for our health? Or are they looking out for $omething else entirely?
*******************************************
In Washington, Joyce Lovelace of Kentucky told lawmakers that New England Compounding killed her husband, Judge Eddie Lovelace, one of the first patients to die in the outbreak. He got injections of the pharmacy’s contaminated steroid for back pain resulting from a car accident. Weeks later, he died of a stroke. “Why did so many medical providers purchase this product from unregulated or poorly regulated sources,” Joyce Lovelace asked from a wheelchair.
I hold them responsible.
Cadden then came in, under a subpoena to appear. His attorney, Bruce Singal of Boston, had delivered a letter to subcommittee members explaining that Cadden had “strong desires’’ to answer the committee’s questions, but given state and federal investigations, Singal had advised him to exercise his Fifth Amendment privilege. He said Cadden had cooperated with investigators to quickly recall 17,676 doses of the contaminated steroid so no one else would get sick.
After Cadden was seated, Representative Clifford Stearns, a Florida Republican and committee chairman, said the loved ones of those who died and patients who are sick “deserve some answers today. Mr. Cadden, I ask you to reconsider and tell this committee how this tragedy happened.’’
Cadden, who was also chief pharmacist of New England Compounding, declined. Stearns and Representative Diana DeGette, a Colorado Democrat, tried to prod Cadden into answering questions, but eventually Stearns dismissed him. As Cadden walked outside, he was followed for two blocks by television crews shouting questions. He looked straight ahead and did not say a word, before getting into a waiting black sport utility vehicle.
Afterward, Representative Edward Markey, a Massachusetts Democrat, said he was “very disappointed. This was his opportunity to explain to the American people.’’ But Markey added, “He is going to be charged with very serious violations of law, so I understand why he pled the Fifth.’’
Is he?
When her turn came, Hamburg called federal and state regulations of compounding pharmacies a “crazy quilt’’ of confusing rules. She said the FDA can routinely inspect and demand documents from manufacturers, but not from compounders. But committee members said New England Compounding was acting as a manufacturer, shipping thousands of doses to dozens of states, and the agency could have stepped in.
They pointed to a 2006 warning letter from the FDA, which threatened New England Compounding with “seizure or injunction” if it did not improve its practices.
“Are you saying that letter was an empty threat?’’ Stearns asked.
Yup.
Congressional investigators were also highly critical of the Massachusetts pharmacy board. “It seems to me the ball was dropped and dropped in a big way,’’ DeGette said.
Dr. Lauren Smith, interim commissioner of the state Department of Public Health, who also testified before the committee, agreed. “There were certainly missed opportunities and lapses of judgment,’’ she said.
Representative Janice Schakowsky, an Illinois Democrat, asked whether the board failed to take strict action against New England Compounding, including weakening a 2006 consent agreement with the company, because it was too close to the pharmacy. Board member Sophia Pasedis worked for New England Compounding and later for its sister company Ameridose. The state has since asked her to resign from the board.
“It seems like the board was more interested in protecting pharmacists than in protecting consumers,’’ Schakowsky said....
--more--"
Related: Senators fault FDA on Ameridose
Shutdown spurs hunt for medication sources
Ameridose alerted state officials of its layoffs in a letter made public Tuesday. In that letter, dated Friday, Nov. 9, the company’s director of human resources wrote that 676 Ameridose employees were laid off last Friday, and that an additional 31 Ameridose employees would be laid off at the end of November.
Ameridose alerted state officials of its layoffs in a letter made public Tuesday. In that letter, dated Friday, Nov. 9, the company’s director of human resources wrote that 676 Ameridose employees were laid off last Friday, and that an additional 31 Ameridose employees would be laid off at the end of November.
Also see: Ameridose must remain shut down
"States try to strengthen rules on drug compounders" by Todd Wallack | Globe Staff, November 16, 2012
State pharmacy regulators across the country are moving to strengthen their oversight of compounding pharmacies like the one in Framingham that has been blamed for a deadly outbreak of fungal meningitis in 19 states....
Ohio and Texas have stepped up inspections in their states, Florida pulled the license of a pharmacy with a history of past problems, and several states have created task forces to revamp their rules.
Both government officials and watchdog groups say the outbreak underscores the need for tougher rules and enforcement to protect patients from compounding pharmacies with sloppy practices — especially those like New England Compounding that shipped large volumes of sterile injections across the country.
“I think it’s fair to say every state is looking at this,” said Caroline Juran, executive director of the Virginia Board of Pharmacy, which plans to take up the topic at its board meeting next month.
So far, at least 32 people have died and 461 have become ill from tainted steroid injections made by New England Compounding. The company has since shut down, laid off almost all its employees, and drawn dozens of lawsuits.
In Washington, lawmakers hammered Dr. Margaret Hamburg, the Food and Drug Administration commissioner, on Wednesday and Thursday, for her agency’s failure to crack down on New England Compounding and similar pharmacies, while she blamed a “crazy quilt” of confusing state and federal rules that have let many compounding companies operate with little oversight. Hamburg urged Congress to give the FDA more authority to inspect and demand documents from such pharmacies.
In the meantime, states are trying to beef up their own rules and enforcement....
Most states simply require out-of-state pharmacies to fill out a brief form, prove they have a current license in their home state, and pay a fee. A handful of states, such as Massachusetts, have no licensing requirements for out-of-state pharmacies. Instead, states rely on pharmacies’ home states to follow up on complaints and do regular inspections....
(Blog editor shrugs shoulders and holds palms skyward)
--more--"
Related: Mass. woman who received pain shot may have meningitis
Someone has to be charged with a crime, right?
"Pharmacy case may see call for jail time; US prosecutor’s decision awaited" by Kay Lazar | Globe Staff, November 21, 2012
Ohio and Texas have stepped up inspections in their states, Florida pulled the license of a pharmacy with a history of past problems, and several states have created task forces to revamp their rules.
Both government officials and watchdog groups say the outbreak underscores the need for tougher rules and enforcement to protect patients from compounding pharmacies with sloppy practices — especially those like New England Compounding that shipped large volumes of sterile injections across the country.
“I think it’s fair to say every state is looking at this,” said Caroline Juran, executive director of the Virginia Board of Pharmacy, which plans to take up the topic at its board meeting next month.
So far, at least 32 people have died and 461 have become ill from tainted steroid injections made by New England Compounding. The company has since shut down, laid off almost all its employees, and drawn dozens of lawsuits.
In Washington, lawmakers hammered Dr. Margaret Hamburg, the Food and Drug Administration commissioner, on Wednesday and Thursday, for her agency’s failure to crack down on New England Compounding and similar pharmacies, while she blamed a “crazy quilt” of confusing state and federal rules that have let many compounding companies operate with little oversight. Hamburg urged Congress to give the FDA more authority to inspect and demand documents from such pharmacies.
In the meantime, states are trying to beef up their own rules and enforcement....
Most states simply require out-of-state pharmacies to fill out a brief form, prove they have a current license in their home state, and pay a fee. A handful of states, such as Massachusetts, have no licensing requirements for out-of-state pharmacies. Instead, states rely on pharmacies’ home states to follow up on complaints and do regular inspections....
(Blog editor shrugs shoulders and holds palms skyward)
--more--"
Related: Mass. woman who received pain shot may have meningitis
Someone has to be charged with a crime, right?
"Pharmacy case may see call for jail time; US prosecutor’s decision awaited" by Kay Lazar | Globe Staff, November 21, 2012
The top executives of New England Compounding Center are likely to be criminally prosecuted on federal charges that carry possible prison sentences, according to former prosecutors who cite the large number of people harmed, allegedly by contaminated steroids made by the Framingham pharmacy.
I'm not going to hold my breath.
US Attorney Carmen M. Ortiz, whose Boston office is known for aggressive prosecution of health care companies, acknowledged in a statement last month that she is probing New England Compounding, but has declined further comment. Agents from the US Food and Drug Administration’s Office of Criminal Investigations were seen last month combing through the company’s Framingham offices....
Oh, she better throw the book at them like she did Swartz.
Thirty-four deaths have been blamed on pain injections made by New England Compounding, and 490 patients have developed fungal meningitis or other infections after getting the steroid shots in their backs or joints, according to the federal Centers for Disease Control and Prevention.
Up to 34 dead now, huh?
Graves and other former federal prosecutors and legal specialists interviewed by the Globe said the US attorney’s office is likely to focus on three charges against New England Compounding: selling adulterated (in this case contaminated) drugs in violation of the federal Food, Drug and Cosmetic Act; fraud; and false claims, for defrauding Medicare and Medicaid through the company’s sales of medications that were unsafe to thousands of hospitals and pain clinics nation wide that, in turn, billed the government for treatment of patients insured through these programs.
Penalties for those charges typically range from a maximum of three to 20 years in prison, though federal guidelines allow for a life sentence in cases of health care fraud involving death.
They better.
Companies prosecuted under these provisions typically reach settlements with the government, agreeing to pay multimillion-dollar fines and to change their practices to comply with the law.
Who says you can't buy your way out of jail?
Prosecutors are often satisfied with fines because of the difficulty of proving company executives intended to commit a crime, and jury verdicts are unpredictable.
Excuses, excuses, to let money men off the hook.
But in this case, the former prosecutors say the government is likely to seek jail time for New England Compounding’s top executives under a seldom- used provision of the law known as the responsible corporate officer doctrine.
Why is it a "seldom-used" provi$io.... oh, right.
This doctrine allows federal prosecutors to hold a company’s executives criminally responsible for wrongdoing of employees, even if the executives did not participate in or know anything about the criminal activity. Conviction carries a maximum one-year prison sentence.
I'm thinking bank CEOs and managers, aren't you?
“The government has gone after a lot of big companies and gotten a lot of money, but I don’t think they feel they are having the deterrent effect if people don’t go to jail,” said Stephen Huggard, a Boston attorney and former federal prosecutor in the Boston US attorney’s office....
Robert M. Thomas Jr., formerly a federal prosecutor in Maryland and now a Boston attorney representing employees in whistleblower cases against their former companies, said, “You start with lower-level employees. You may have to give them immunity to talk.”
--more--"
I'm not going to hold my breath.
US Attorney Carmen M. Ortiz, whose Boston office is known for aggressive prosecution of health care companies, acknowledged in a statement last month that she is probing New England Compounding, but has declined further comment. Agents from the US Food and Drug Administration’s Office of Criminal Investigations were seen last month combing through the company’s Framingham offices....
Oh, she better throw the book at them like she did Swartz.
Thirty-four deaths have been blamed on pain injections made by New England Compounding, and 490 patients have developed fungal meningitis or other infections after getting the steroid shots in their backs or joints, according to the federal Centers for Disease Control and Prevention.
Up to 34 dead now, huh?
Graves and other former federal prosecutors and legal specialists interviewed by the Globe said the US attorney’s office is likely to focus on three charges against New England Compounding: selling adulterated (in this case contaminated) drugs in violation of the federal Food, Drug and Cosmetic Act; fraud; and false claims, for defrauding Medicare and Medicaid through the company’s sales of medications that were unsafe to thousands of hospitals and pain clinics nation wide that, in turn, billed the government for treatment of patients insured through these programs.
Penalties for those charges typically range from a maximum of three to 20 years in prison, though federal guidelines allow for a life sentence in cases of health care fraud involving death.
They better.
Companies prosecuted under these provisions typically reach settlements with the government, agreeing to pay multimillion-dollar fines and to change their practices to comply with the law.
Who says you can't buy your way out of jail?
Prosecutors are often satisfied with fines because of the difficulty of proving company executives intended to commit a crime, and jury verdicts are unpredictable.
Excuses, excuses, to let money men off the hook.
But in this case, the former prosecutors say the government is likely to seek jail time for New England Compounding’s top executives under a seldom- used provision of the law known as the responsible corporate officer doctrine.
Why is it a "seldom-used" provi$io.... oh, right.
This doctrine allows federal prosecutors to hold a company’s executives criminally responsible for wrongdoing of employees, even if the executives did not participate in or know anything about the criminal activity. Conviction carries a maximum one-year prison sentence.
I'm thinking bank CEOs and managers, aren't you?
“The government has gone after a lot of big companies and gotten a lot of money, but I don’t think they feel they are having the deterrent effect if people don’t go to jail,” said Stephen Huggard, a Boston attorney and former federal prosecutor in the Boston US attorney’s office....
Robert M. Thomas Jr., formerly a federal prosecutor in Maryland and now a Boston attorney representing employees in whistleblower cases against their former companies, said, “You start with lower-level employees. You may have to give them immunity to talk.”
--more--"
"Little scrutiny as drug compounder expanded; Early fears about tainted products, but no crackdown" by Liz Kowalczyk and Todd Wallack | Globe Staff, December 09, 2012
In February 2003, 11 federal and state health regulators gathered around a conference table in Boston, joined by three colleagues patched in on telemonitors from Washington, to decide the fate of New England Compounding Center.
Woah, now it is OVER TEN YEARS AGO?
Woah, now it is OVER TEN YEARS AGO?
The tiny Massachusetts pharmacy seemed too obscure to require so much firepower. But at least four patients had recently died of meningitis caused by contaminated steroid injections made by compounding pharmacies in California and South Carolina, and federal investigators were worried they could have another public health crisis on their hands, according to documents provided by a US Senate committee and the US Food and Drug Administration.
Similar steroids mixed by New England Compounding were believed to contain toxins — they had possibly sickened at least four patients. And the company was expanding — fast. Despite initially promising to sell medicines only to Massachusetts doctors, co-owner Barry Cadden had acquired pharmacy licenses in at least 13 states, filed applications in many more, and begun to hire a sales force to exploit the burgeoning and profitable market for custom-made drugs.
Before the group of regulators disbanded, they decided the state, not the FDA, would take the lead in disciplining the specialty pharmacy. That proved to be a key choice. California and South Carolina regulators took strong steps that cost the compounders involved in the earlier contamination cases their businesses.
But Massachusetts ultimately would take no significant action against New England Compounding, the company that a decade later is blamed for a national meningitis outbreak that has sickened 541 people and killed 36 — allowing it to flourish into a national distributor of thousands of steroids, painkillers, and other medicines to doctors and hospitals.
“Barry owned the market of pain management,’’ said Jim Nahill, who owns Pallimed Pharmacy in Woburn.
The Massachusetts pharmacy board did not take action against New England Compounding until October of this year. It forced the pharmacy to shut down after investigators traced the meningitis outbreak to one of its drugs — methylprednisolone acetate — one of the two steroids believed to have sickened patients in 2002.
Before Cadden started New England Compounding, he was a traditional retail pharmacist at a Rhode Island Walgreens store for eight years, with no experience managing a business. In his 1998 application for a Massachusetts pharmacy license, Cadden said he planned to customize drugs for Massachusetts doctors, particularly those in the suburbs west of Boston.
The Framingham pharmacy was located in the same red brick complex as a recycling business owned by his wife’s family, the Conigliaros, who helped him start New England Compounding.
Right away, Cadden struck others compounders, who tend to share recipes, as reticent — almost like he wanted to fly under the radar.
“They were still setting up when I knocked on the door,’’ recalled Dennis Katz, the owner of Hopkinton Drug, a compounding pharmacy 15 minutes away from New England Compounding. “I said, ‘Welcome to the area. If I can help you with a formula, let me know.’ I was not invited in, which I thought was weird.’’
New England Compounding was among dozens of independent pharmacies that eagerly began compounding around then, as chain drugstores and Internet mail order outfits threatened small pharmacies by taking over much of the business of filling traditional prescriptions. Insurers were also clamping down on payments, and by the early 2000s, the number of independent pharmacies in the United States had plunged to 23,000 from 40,000 in 1980.
There was also a desire among doctors and patients to more aggressively treat pain, with doses and drug combinations not supplied by big pharmaceutical companies. Patients wanted natural hormone replacement therapies, anti-aging formulas, and veterinary drugs. Consultants and compounders boasted that impossibly large profits could be made.
“Anybody know what the average margin on a compounded product is?’’ businessman Mickey Letson, then president of a major compounding supply company, asked a group at a national trade show in Atlanta in 2002. “Seventy-five percent minimum gross profits. Depending on what field you’re in it can run into the thousands of percent.’’
Lester Nathan of Schenec tady, N.Y., who dubbed himself the “million dollar marketing coach,’’ helped over 300 pharmacies market their compounded products. “The raw materials are cheap and the pharmacist is getting paid for a higher level of product,’’ Nathan said in an interview. “Compounding is one of the areas they should have been in anyway, in order to serve their patients better because it’s customizing medicine.’’
A Texas-based company called Professional Compounding Centers of America, started by a Houston pharmacist in 1981, received a growing number of calls from traditional pharmacists who wanted to learn to custom make drugs. The company mailed kits that included formulas, chemicals, and equipment. Customers included New England Compounding, which bought nonsterilized chemical powder to mix into sterile injectable drugs, the riskiest, most demanding form of compounding.
By 2002, the year the FDA started investigating the firm, it was clear that New England Compounding’s strategy went far beyond the local focus Cadden had promised. Yet state and federal regulators did next to nothing to slow its growth.
But please, please don't let this interrupt the narrative of this wonderful government that cares for you so much.
But please, please don't let this interrupt the narrative of this wonderful government that cares for you so much.
That year, the pharmacy took over a neighboring store to double its space. Cadden proudly told federal regulators he planned to sell drugs in all 50 states. And pharmacy boards — apparently largely unaware of the company’s tussles with regulators — cooperated, quickly granting New England Compounding licenses.
In one instance, Charles Young, then executive director of the Massachusetts pharmacy board, assured his counterparts in Florida that the pharmacy was in “good standing.’’ Young dated the letter April 10, 2002 — the same day FDA and board investigators arrived at the pharmacy to investigate potential contamination of the steroid betamethasone and found Cadden refusing to provide records.
During these years, the company marketed its products aggressively, borrowing techniques from large drug manufacturers. Cadden set up an exhibit booth at a national meeting of eye doctors in 2003, faxed fliers to doctors’ offices in 2004 advertising fast-acting “extra strength triple anesthetic cream,’’ and cosponsored the Eastern Pain Association meeting in Manhattan in 2005.
In promotional materials faxed to doctors’ offices and distributed at national meetings, the company promoted its rigorous sterility testing and attention to industry standards. One 2005 pamphlet boasted the company was licensed in 49 states, included a “state-of-the-art laboratory,” and used an independent testing firm.
Doctors say Cadden sometimes shipped large amounts of drugs to them on consignment, requiring them to fax patient names only as each dose was used. It is a more convenient system for physicians than providing a prescription before receiving each vial — as required by Massachusetts law.
“When you are good at what you do in our business, you create waves of business you can’t predict,’’ said Nahill, the Woburn compounder. It’s a competitive business, he added, and if a compounder isn’t responsive to doctors’ needs, “they will go somewhere else.’’
Cadden’s company got invaluable help along the way from his brother-in-law, a Florida anesthesiologist with contacts among fellow pain specialists and years of experience using compounded pain drugs.
Dr. Douglas Conigliaro, whose wife, Carla, was listed as the pharmacy’s majority owner, started a marketing company in 2002 that promoted New England Compounding’s products. And he introduced Cadden to a Florida pharmacist who had long supplied Conigliaro with compounded medicines.
“I think Doug wished Barry would do a little more volume,’’ said Sam Pratt, recalling that Conigliaro was interested in how many prescriptions he mixed per day. The men talked in 2005 at a Florida pharmacy conference, where Cadden was in high demand. Pratt said Cadden answered constant cellphone calls as they walked the convention floor.
Conigliaro has not responded to request for comment. Cadden has declined to comment through his attorney.
While Conigliaro was viewed by workers as an aggressive businessman, Cadden was friendly, they said. One former salesman, who did not want to be identified because he is afraid of damaging his career, said Cadden was “very dynamic” and loved talking about his compounding work. During his job interview, he estimated Cadden talked for 43 of the 45 minutes.
Beneath Cadden’s outgoing personality, however, he had a competitive nature.
Several years after they met in Florida, Pratt decided to call Cadden for a favor. He wanted to know how to make a certain medication, but Cadden was tight-lipped. “He said if he was going to do it for anyone, he’d do it for me,’’ Pratt recalled. “He wouldn't tell me. It was his market.’’
Cadden was similarly circumspect when FDA inspectors visited New England Compounding to investigate reports that several patients had developed meningitis-like symptoms after injections with the company’s drugs. He chafed and sometimes turned uncooperative, according to internal agency reports.
One day in April 2002, inspectors noted that Cadden had stored a 1,000-milliliter beaker of betamethasone — the steroid believed to have sickened at least two patients — in a protective hood while awaiting results of sterility tests, which could take a week. Cadden had covered the beaker with several sheets of aluminum foil.
Investigators warned the solution could become contaminated sitting out that long, but Cadden said he did not want “to waste money” on vials until he knew the product was sterile and could be sold. At a meeting a week later, Cadden told investigators the beaker did not contain betamethasone at all.
Federal and state officials inspected New England Compounding nine times in 2002 and 2003, and the FDA issued the pharmacy two form 483s — a formal list of concerns observed during inspections — identifying problems with the sterilization and mixing of drugs.
In response to one, Cadden said he had hired a consultant and taken a series of corrective actions, including sanitizing work spaces on a regular schedule and cleaning and testing the autoclave, used for sterilizing equipment.
The investigation occurred amid the unfolding tragedies in California and South Carolina. These cases were a key component of the FDA’s presentation to state pharmacy regulators at the February 2003 meeting.
The agency’s officials wanted to impress on the pharmacy board “the potential for serious public health consequences if NECC’s compounding practices, particularly those relating to sterile products, are not improved,’’ David Elder, then director of compliance for the agency’s New England office, told the group, according to a memo summarizing the meeting.
Thirteen patients were hospitalized, including five with meningitis, and three died, after receiving injections of the steroid betamethasone made by Doc’s Pharmacy in Walnut Creek, Calif. — cases that came to light in the summer of 2001. In South Carolina the next year, four patients contracted fungal meningitis from methylprednisolone made by Urgent Care in Spartanburg, and at least one died.
During the meeting, the FDA also pointed out that an April 2002 US Supreme Court ruling had weakened its authority over compounding pharmacies, while leaving intact its power to regulate manufacturers.
Though New England Compounding had begun its national expansion by that time, the regulators, for reasons that are unclear, decided the company was still a compounder, and the FDA handed over primary oversight responsibility to the state.
I'm trying to think of one. How about you, reader$?
The state pharmacy board initially proposed a three-year probation and reprimand of the company, but backed off when the firm protested that the action would threaten its national business by scaring off customers. Instead, the board signed a consent agreement with the pharmacy in 2006 that required it to improve its sterile compounding procedures.
I'm trying to think of one. How about you, reader$?
The state pharmacy board initially proposed a three-year probation and reprimand of the company, but backed off when the firm protested that the action would threaten its national business by scaring off customers. Instead, the board signed a consent agreement with the pharmacy in 2006 that required it to improve its sterile compounding procedures.
By that time, William Koch, a patient injected with the pharmacy’s methylprednisolone acetate in 2002 at a Rochester, N.Y., hospital, had died of bacterial meningitis, according to a lawsuit filed against the pharmacy in 2004 and confidentially settled.
Harold Sparr, a Massachusetts pharmacy board member from 1992 to 2006, said board members did not understand what was going on inside New England Compounding. Maybe, he said, the company “let things slide for the almighty buck.’’
State health officials now acknowledge they missed opportunities to ensure the pharmacy’s practices were safe and say they have now stepped up enforcement.
That NEEDLESSLY COST LIVES!
We call it CRIMINAL NEGLIGENCE here!
Meanwhile, the FDA remained involved, sending New England Compounding an official warning letter in 2006 detailing deficiencies it found during its inspections.
That NEEDLESSLY COST LIVES!
We call it CRIMINAL NEGLIGENCE here!
Meanwhile, the FDA remained involved, sending New England Compounding an official warning letter in 2006 detailing deficiencies it found during its inspections.
Cadden wrote back in 2007 that the findings were invalid because the letter came so long after the 2002 and 2003 inspections. The FDA sent a final letter in 2008 threatening follow-up inspections or even closure of the pharmacy, but never made good on those threats.
In response to Globe questions about why Cadden was uncooperative with the FDA during the early 2000s, his attorney said, “This sort of historical retrospective sheds no light on the current issue.’’
Actually, it does. It shows a pattern.
Actually, it does. It shows a pattern.
“Whatever alleged conditions in the NECC lab may be dredged up from many years back simply shed no light on the mystery of what went so terribly wrong for the first time in June and August, and why,” Bruce Singal said in a written statement.
Do these guys ever hear themselves?
Do these guys ever hear themselves?
Undertook big expansion
Its problems with the FDA apparently settled, New England Compounding embarked on the largest expansion in its history. Cadden and Gregory Conigliaro, younger brother to Doug, launched another company, Ameridose, in 2006, which focused on repackaging and custom-making medications for hospitals.
The pharmacy focused on small pain and eye clinics, but as a growing number of drugs became backlogged, hospitals signed on as customers and its sales exploded.
One former manager of its sister marketing company said that by 2008, New England Compounding was “wildly profitable,’’ earning $13 million in revenue, of which more than $5 million was pretax income. The manager wanted to remain anonymous because he is worried about being sued.
The company grew from about 20 employees in 2009 to 50 by the time it shut down two months ago.
“It was crazy, crazy expansion,” said one former sales representative who did not want to be identified because he signed a confidentiality agreement.
Another salesman, the one who did not want to be identified because he was afraid it would hurt his career, said Cadden wanted his pharmacy to grow, particularly after watching Ameridose become much larger. “He had sort of a love-hate relationship with Ameridose.”
But New England Compounding benefited from its ties to Ameridose, which frequently referred customers to its sister company for products it couldn’t supply itself.
FDA records for this year show that more than three dozen hospitals purchased drugs in shipments of 500 doses or more — even though Mas sachusetts law prohibited New England Compounding from selling drugs without patient-specific prescriptions because it was not licensed as a manufacturer.
Gaston Memorial Hospital in North Carolina purchased 900 vials of nalbuphine, a powerful painkiller, in July alone. The hospital acknowledged it did not have individual prescriptions for each dose.
Hospital spokeswoman Dallas Wilborn said the hospital was forced to buy from the company “due to a shortage of medications from our traditional suppliers.”
The salesman who signed the confidentiality agreement said hospitals were desperate for medications in short supply. “They were freaking out,” he said. “If they couldn’t get these drugs, patients were going to die.”
Or if they did get 'em (sigh).
Or if they did get 'em (sigh).
--more--"
More:
Montigny challenges pharmacy trade group on oversight
Pharmacy in meningitis outbreak files for bankruptcy
More:
Montigny challenges pharmacy trade group on oversight
Pharmacy in meningitis outbreak files for bankruptcy
A wish for relief, a tainted drug, a tragic outcome
His death appears to have been the first of at least 39 linked to the pharmacy’s steroids, and it launched one of the nation’s worst public health disasters involving medications.
Up to 39 now.
His death appears to have been the first of at least 39 linked to the pharmacy’s steroids, and it launched one of the nation’s worst public health disasters involving medications.
Up to 39 now.
"Owners drew $16m from pharmacy tied to deaths" by Todd Wallack | Globe Staff, January 22, 2013
The owners of the Framingham pharmacy blamed for the fungal meningitis outbreak that has killed dozens of people and sickened hundreds more pulled millions of dollars out of the company in the last year.
Bankruptcy records show the four family members who cofounded New England Compounding Center received more than $16 million in wages and profits from the firm from December 2011 through November 2012 — roughly equal to half its sales during this period.
The filings also show the family members racked up $90,000 on corporate American Express credit cards, including charges made after the company shut down in early October. The company filed for Chapter 11 bankruptcy just before Christmas.
An attorney involved in the bankruptcy case said he felt “shock and amazement” when he saw the list of payments for family members.
“It’s tremendously unusual,” said William R. Baldiga, a partner at the Boston law firm Brown Rudnick who is representing the committee of unsecured creditors owed money by the company, including people who were sickened by the company’s drugs....
Not really. It's called looting, and we see it all the time.
At least 44 people have died and 678 have become ill in 19 states from fungal meningitis or other complications after receiving the shots, according to the federal Centers for Disease Control and Prevention.
State and federal investigators who inspected the facility last fall have said they found that the company ignored signs that the “clean rooms” where the steroids were prepared were contaminated and did not do enough to test the drugs before shipping them to pain clinics.
Lawyers representing victims have filed hundreds of lawsuits and estimate the potential damages are likely to total hundreds of millions of dollars — far more than the company has in assets.
In documents filed in US Bankruptcy Court in Boston late Friday, the pharmacy reported it had just $1.3 million in cash and owed nearly $900,000 to unsecured creditors such as FedEx, not counting potential legal costs. The company also indicated it had insurance, which could potentially cover a portion of claims to victims.
The records show that Barry Cadden, the lead pharmacist and main executive in charge of the company, and his wife, Lisa, together pulled $6 million out of the company from late December 2011 through November 2012, in wages and shareholder payments. Lisa’s brother Gregory Conigliaro received $1.6 million during this span. And Carla Conigliaro, the majority shareholder and wife of Lisa’s brother Douglas Conigliaro — a doctor who cofounded the company’s marketing and sales affiliate — pulled out $8.7 million....
They took the money and ran!
Fredric Ellis, a Boston attorney representing several victims, said there is no evidence that the founders “raided” the company’s coffers shortly before it filed for bankruptcy protection.
Then what would you call it?
But he said the records show that the company was growing rapidly and generated enormous profits for the owners before it shut down.
“They were clearly taking a lot of money out while it was operating,” Ellis said. “They cashed out, no doubt about it.”
The records show the company’s revenue skyrocketed as it supplied a growing number of clinics and hospitals across the country with specially formulated medications, some in short supply. The company’s sales jumped from $19.9 million in 2010 to $27.3 million in 2011, an increase of 37 percent. And last year, the company’s sales reached $32.4 million — even though it shut down operations and gave up its pharmacy license in Massachusetts about three-quarters of the way through the year.
Baldiga said he was concerned that the company continued to pay the company’s owners hundreds of thousands of dollars in October and November — including credit card charges at Whole Foods Market, Panera Bread, and Barnes & Noble — even after the company was linked to the meningitis outbreak and recalled the tainted steroids on Sept. 26. He also flagged a $190 charge at the MGM Grand at Foxwoods, the Connecticut casino, on Sept. 28, just days before the shutdown.
Gambling with the money they made gambling with your life.
“After this tragedy unfolded, the company was still paying for the personal lifestyles of the owners of the company even after the company was clearly insolvent,” Baldiga said. “It shows a cavalier attitude” toward victims who are waiting to be compensated.
Overall, the company paid more than $72,000 in American Express charges for the Caddens and more than $18,000 for Carla Conigliaro. The company also paid $30,000 over the past year for two leased luxury cars and $4.7 million to affiliated companies.
--more--"
At least they are taking responsibility, right?
"The Framingham compounding pharmacy blamed for producing tainted steroid injections that have killed dozens of people across the country is pointing the finger elsewhere."
Let's add to the outrage:
Data show $20m held by meningitis-tied pharmacy owners
Little insurance money for meningitis claims
Translation: they got away with it.
At least this will make you feel better:
"Specialty drug labs in Mass. fail safety inspection; 4 compounders out of 37 comply; state orders 11 pharmacies closed" by Kay Lazar and Chelsea Conaboy | Globe Staff, February 06, 2013
Surprise state inspections at 37 specialty pharmacies in Massachusetts show that only four have been fully complying with industry safety standards, health officials announced Tuesday, a finding that underscores concerns about the risk of drug contamination.
I'm not feeling so good.
All 37 are similar to the Framingham compounding pharmacy blamed for the fatal outbreak of fungal meningitis last year.
Serious violations of state pharmacy regulations were found in 11 compounders, prompting the state to temporarily shut down all or part of their operations, while 21 others were cited for more minor violations....
And yet here this f***ing state is all bunged-up over medical marijuana regulations.
The Department of Public Health began the inspections in October after New England Compounding Center’s tainted steroids were linked last fall to meningitis and other infections that have sickened nearly 700 people across the country and been blamed for 45 deaths.
Patient safety specialists, who have long advocated for stricter oversight of the industry nationwide, say they are not surprised that only a fraction of the state’s sterile compounding pharmacies, which make injectable and intravenous medications, were obeying all the rules.
“I am sure the same things would be found in other states, not just Massachusetts,” said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit.
“If any good can come of this tragedy at all, it is that people have awakened to the risks now.”
Risks were there should be none.
--more--"
Also see: New Jersey compounding firm recalls products
The owners of the Framingham pharmacy blamed for the fungal meningitis outbreak that has killed dozens of people and sickened hundreds more pulled millions of dollars out of the company in the last year.
Bankruptcy records show the four family members who cofounded New England Compounding Center received more than $16 million in wages and profits from the firm from December 2011 through November 2012 — roughly equal to half its sales during this period.
The filings also show the family members racked up $90,000 on corporate American Express credit cards, including charges made after the company shut down in early October. The company filed for Chapter 11 bankruptcy just before Christmas.
An attorney involved in the bankruptcy case said he felt “shock and amazement” when he saw the list of payments for family members.
“It’s tremendously unusual,” said William R. Baldiga, a partner at the Boston law firm Brown Rudnick who is representing the committee of unsecured creditors owed money by the company, including people who were sickened by the company’s drugs....
Not really. It's called looting, and we see it all the time.
At least 44 people have died and 678 have become ill in 19 states from fungal meningitis or other complications after receiving the shots, according to the federal Centers for Disease Control and Prevention.
State and federal investigators who inspected the facility last fall have said they found that the company ignored signs that the “clean rooms” where the steroids were prepared were contaminated and did not do enough to test the drugs before shipping them to pain clinics.
Lawyers representing victims have filed hundreds of lawsuits and estimate the potential damages are likely to total hundreds of millions of dollars — far more than the company has in assets.
In documents filed in US Bankruptcy Court in Boston late Friday, the pharmacy reported it had just $1.3 million in cash and owed nearly $900,000 to unsecured creditors such as FedEx, not counting potential legal costs. The company also indicated it had insurance, which could potentially cover a portion of claims to victims.
The records show that Barry Cadden, the lead pharmacist and main executive in charge of the company, and his wife, Lisa, together pulled $6 million out of the company from late December 2011 through November 2012, in wages and shareholder payments. Lisa’s brother Gregory Conigliaro received $1.6 million during this span. And Carla Conigliaro, the majority shareholder and wife of Lisa’s brother Douglas Conigliaro — a doctor who cofounded the company’s marketing and sales affiliate — pulled out $8.7 million....
They took the money and ran!
Fredric Ellis, a Boston attorney representing several victims, said there is no evidence that the founders “raided” the company’s coffers shortly before it filed for bankruptcy protection.
Then what would you call it?
But he said the records show that the company was growing rapidly and generated enormous profits for the owners before it shut down.
“They were clearly taking a lot of money out while it was operating,” Ellis said. “They cashed out, no doubt about it.”
The records show the company’s revenue skyrocketed as it supplied a growing number of clinics and hospitals across the country with specially formulated medications, some in short supply. The company’s sales jumped from $19.9 million in 2010 to $27.3 million in 2011, an increase of 37 percent. And last year, the company’s sales reached $32.4 million — even though it shut down operations and gave up its pharmacy license in Massachusetts about three-quarters of the way through the year.
Baldiga said he was concerned that the company continued to pay the company’s owners hundreds of thousands of dollars in October and November — including credit card charges at Whole Foods Market, Panera Bread, and Barnes & Noble — even after the company was linked to the meningitis outbreak and recalled the tainted steroids on Sept. 26. He also flagged a $190 charge at the MGM Grand at Foxwoods, the Connecticut casino, on Sept. 28, just days before the shutdown.
Gambling with the money they made gambling with your life.
“After this tragedy unfolded, the company was still paying for the personal lifestyles of the owners of the company even after the company was clearly insolvent,” Baldiga said. “It shows a cavalier attitude” toward victims who are waiting to be compensated.
Overall, the company paid more than $72,000 in American Express charges for the Caddens and more than $18,000 for Carla Conigliaro. The company also paid $30,000 over the past year for two leased luxury cars and $4.7 million to affiliated companies.
--more--"
At least they are taking responsibility, right?
"The Framingham compounding pharmacy blamed for producing tainted steroid injections that have killed dozens of people across the country is pointing the finger elsewhere."
Let's add to the outrage:
Data show $20m held by meningitis-tied pharmacy owners
Little insurance money for meningitis claims
Translation: they got away with it.
At least this will make you feel better:
"Specialty drug labs in Mass. fail safety inspection; 4 compounders out of 37 comply; state orders 11 pharmacies closed" by Kay Lazar and Chelsea Conaboy | Globe Staff, February 06, 2013
Surprise state inspections at 37 specialty pharmacies in Massachusetts show that only four have been fully complying with industry safety standards, health officials announced Tuesday, a finding that underscores concerns about the risk of drug contamination.
I'm not feeling so good.
All 37 are similar to the Framingham compounding pharmacy blamed for the fatal outbreak of fungal meningitis last year.
Serious violations of state pharmacy regulations were found in 11 compounders, prompting the state to temporarily shut down all or part of their operations, while 21 others were cited for more minor violations....
And yet here this f***ing state is all bunged-up over medical marijuana regulations.
The Department of Public Health began the inspections in October after New England Compounding Center’s tainted steroids were linked last fall to meningitis and other infections that have sickened nearly 700 people across the country and been blamed for 45 deaths.
Patient safety specialists, who have long advocated for stricter oversight of the industry nationwide, say they are not surprised that only a fraction of the state’s sterile compounding pharmacies, which make injectable and intravenous medications, were obeying all the rules.
“I am sure the same things would be found in other states, not just Massachusetts,” said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit.
“If any good can come of this tragedy at all, it is that people have awakened to the risks now.”
Risks were there should be none.
--more--"
Also see: New Jersey compounding firm recalls products
