Update on What the News Reports Are Missing in the New England Compounding Center Meningitis Outbreak Case; And Why We Need And Must Have Compounded Drugs Reposted

This new article, 47 patients linked to meningitis infections, from CNN notes that nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.  However, there are a number of things that the reporters fail to point out.    Some articles cite the tragic Franck's case involving the 21 dead horses.  The Food and Drug Administration attempted to stop Franck in that case but a district court judge in Florida said it did not have any jurisdiction over veterinary compounding.  The FDA appeal to the 11th Circuit Federal Court of Appeal.  The case will be argued next month.  In the mean time Franck was at it again, causing eye infections from human drug compounds.  No one can fault the FDA in that case because the FDA had tried to stop Franck.  The state board of pharmacy imposed a fine for the dead horses.  The insurance companies are now suing Franck to get back their money.

Other articles fail to cite the end result of the Apothecure and Gary D. Osborn case, where human compounded drugs resulted in deaths.  In that case the federal government prosecuted Apothecure and Gary D. Osborn after all the civil lawsuits.  Apothecure and Gary D. Osborn pled guilty but were recently sentenced to no jail time and a $100,000 fine was imposed on both-- not much for the harm caused.  But again the FDA and the United States Attorney's Office in the Northern District of Texas did take action.  They did try to stop the bad compounders.

But as my previous post noted, we must have compounded drugs. No one seems to be pointing out that a lot higher percentage of compounded drugs are used on animals. That is so evident in the veterinary world where most of the drugs used for animals are either human drugs or most likely compounded drugs made special for a specific animal.    What must continue to be stressed is that there is a place for compounded drugs and that there are good compounding pharmacies and pharmacists out there who do everything within their powers to follow all the rules and regulations, who have compliant sterile rooms, who spend the money to test to make sure the compound is what it is suppose to be.  Tragic as the New England Compounding Center meningitis outbreak is hopefully the world of compounded drugs for both humans and animals will become a better, safer environment, not one that no longer exists.

Update:  News articles are now reporting on the Apothecure and Gary D. Osborn case.  Still not much coverage on why we must have compounded drugs in the United States.  See previous post for a list of reasons compounded medications for animals and humans are essential.  Here is a repost of that blog entry:

This is a previous post that has been updated.  It is now more important than ever not to lose sight of the fact that compounded medications are essential to both pets and humans.  Do changes in regulations, laws,and enforcement need to be made.  Yes, that is clear.  However, do compounded drugs need to be a thing of the past. No, absolutely not. This post  will hopefully help to explain some of the reasons: Why We Need and Must Have Compounded Medications.

In the wake of the tragic deaths in the New England Compounding Center case, Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications.    If these medications were not available, some patients  (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC.  During his testimony he explained:

Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.

Allen also gave excellent examples of those who rely on compounded medications:

• Infants and children: Compounding pharmacists can transform medicines from

hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and

emulsions for children, at the request of physicians. Flavors offered by

compounding pharmacists can make drugs more palatable to children. In

addition, premature infants often rely on lifesaving and life-sustaining drugs made

only in compounding pharmacies.

• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in

hospitals and clinics are compounded. Because hospital patients are often on

multiple medications, compounding them into one treatment saves the hospital

personnel time and the patient multiple injections or administrations.

• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs

that are compounded pursuant to a doctor’s prescription. Pharmacists can

combine multiple drugs into one treatment, leading to shorter administration times

for cancer patients.

• Senior citizens: Elderly patients often have difficulty with traditional dosage

forms, such as pills taken orally. Compounding pharmacists create alternate

methods of delivery, like transdermal gels, to make it easier for the elderly to take

their medicine.

• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do

not always meet their needs. In many cases, a compounded medication may be

necessary for a non-food animal to be satisfactorily treated.

• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or

other ingredient in commercial products can have their doctor write a prescription

for a compounding pharmacist to customize the same medication without the

offending ingredient.

• Menopausal women: Many women experience significant pain and discomfort as

their bodies’ progress through menopause. Doctors prescribe bioidentical

hormones for patients for whom synthetic hormone treatments may be ineffective

or produce undesired side effects. Several bioidentical hormone products are

available in FDA-approved, one-size-fits-all formulations from pharmaceutical

companies. However, physicians may determine that their patients have unique

needs that warrant prescribing a different compounded hormone treatment. This

often allows patients to take the smallest amount of a given hormone preparation

to treat their symptoms, in conjunction with the recommendation provided by the

Women’s Health Initiative study.

• Patients who require non-traditional dosage forms: Many patients are unable to

take medications orally or as injections – the traditional dosage forms for

manufactured drugs. Compounding pharmacists can create alternate methods of

delivery, like ointments, solutions or suppositories, to fit these patients’ unique

health needs. The pharmaceutical industry supplies only limited strengths of

drugs, which some patients cannot tolerate. It is often necessary for a doctor to

request a different strength of a drug for a patient through compounding.

• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have

discontinued thousands of drug products over the years, due to low profitability.

For certain groups of patients, these were very effective, important, and

sometimes life-saving medications. Such medications are now only available if a

doctor prescribes them to be compounded.

• Hospice patients: End-of-life therapy involves the compounding of many different

and unique dosage forms to allow patients to live out their lives free of pain and

discomfort. Many combinations of drugs are prescribed by doctors and used for

these patients who cannot swallow medications and who don’t have the muscle

mass that is required to receive multiple injections each day. Compounding

pharmacists can provide alternate delivery methods such as oral inhalation, nasal

administration, topical, transdermal or rectal use.

These are important examples of why we need and must have compounded medications in the United States.  The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration.   To read the entire transcript of Dr. Allen's testimony, click here.

9th death reported in meningitis outbreak linked to Framingham pharmacy | MetroWest - WCVB Home

9th death reported in meningitis outbreak linked to Framingham pharmacy | MetroWest - WCVB Home

Meningitis outbreak stirs calls for FDA pharmacy oversight

By David Morgan and Sharon Begley

WASHINGTON/NEW YORK | Tue Oct 9, 2012 1:21am EDT

WASHINGTON/NEW YORK (Reuters) - A deadly U.S. meningitis outbreak tied to contaminated steroid shots should spur new legislation to regulate how pharmacies mix and dose drugs, experts said on Monday.

To read this article click here.

Compounded Drug Crisis Spotlights Regulatory Confusion

Compounded Drug Crisis Spotlights Regulatory Confusion

Meningitis Focus Shifts to Oversight

To read this story from the WSJ, click here.

13,000 people received the injection

Thousands could be at risk in meningitis outbreak, CDC says

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 vaccine 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.
“We know that 13,000 people received the injection,” said Jamila Jones, a public affairs specilialist for the CDC in Atlanta. “They received it at facilities across the country. They are at risk.”
So far, 105 cases and eight deaths have been confirmed nationally, the agency said.

To read rest of article click here.

After nationwide meningitis scare, lawmakers decry compound pharmacies

by DAVID SCHECHTER

WFAA

Posted on October 8, 2012 at 7:09 PM

DALLAS – Lawmakers are on the attack: They say compounding pharmacies, like the one in Massachusetts that has allegedly sickened more than 100, operate in a "regulatory black hole" with very little federal oversight by the FDA.

And that discussion is calling attention to a compounding pharmacy in Dallas that recently pleaded guilty to shipping mislabeled medication that led to three deaths.

When three patients died in Portland, Wa. after taking the same gout medication in 2007 it was no coincidence. A federal investigation quickly pointed back to Dallas and this compounding pharmacy called ApotheCure.

The FDA found ApotheCure's drug mixture was 640 percent stronger than prescribed. Last April, owner Gary Osborn pleaded guilty on misdemeanor charges.

"Once these medications start crossing state lines logistically it's just more difficult," said Mike Johnson, Dean of the University of North Texas System’s College of Pharmacy.

There are 7,500 compounding pharmacies in the U.S., many of them mom and pop operations, that serve local customers.

To read the rest of the article, click here.

Should New Federal Legislation Similar to the Safe Drug Compound Act of 2007 Giving the FDA Authority to Regulate Compounding Be Enacted in Light of the New England Compounding Center Meningitis Outbreak

The Safe Drug Compounding Act of 2007 was drafted as a Senate bill.  Its purpose was to redefine oversight and regulation of the practice of pharmacy compounding by giving power to the FDA to inspect all retail pharmacies that made or dispensed compounded medications and to determine whether or not compounded medications were medically necessary or  "essentially copies" of existing FDA-approved medications. The draft bill also would have taken a number of steps to inhibit the distribution of compounded medications beyond state lines by requiring compounding pharmacies to provide detailed documentation on all intrastate orders and asking state pharmacy boards to "discourage the distribution of inordinate amounts of compound drug products in interstate commerce."  The bill never passed.

Pharmacists and pharmacy organizations opposed the draft bill, expressing concern that the Safe Drug Compounding Act of 2007, would restrain the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations--the American Pharmacists Association, National Community Pharmacists Association, International Academy of Compounding Pharmacists (IACP), American College of Apothecaries, American  Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas Pharmacists Association --  drafted a letter to the bill's expected sponsors. insisting that the draft legislation "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists" and urging that this draft legislation not be introduced.  The coalition of none pointed out the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised to work with Congress to address concerns about compounding.

Compounding critics, however, wanted the draft bill to pass, insisted that the act would clarify several issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA) dealing with compounding, and  claimed it would help correct the problems and dangers associated with pharmacy compounding.  The 2007  legislation was sponsored by Senator Ted Kennedy and co-sponsored by Senators Pat Roberts and Richard Burr.  The bill previously failed to become law.  Senator Richard Blumenthal (D-Conn.) called for stronger federal oversight of compounding pharmacies.  In a letter to the FDA, Senator Blumenthal states:

 “This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies. I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution."

To read the entire letter click here.  Is federal legislation already in the works?  What should the federal legislation cover?  What should it not cover?  How board should it be?

UPDATE 2-US health officials enlist police in growing meningitis scare

Mon Oct 8, 2012 2:20pm EDT

* Drug used as painkiller in back injections * Compounding pharmacies primarily regulated by states
* Company has suspended operations (Updates with more details)
By Tim Ghianni
NASHVILLE, Tenn., Oct 8 (Reuters) - U.S. health authorities scrambled on Monday to identify more cases of a rare form of meningitis, including enlisting local police to find people who might be infected by tainted steroid injections that have so far killed  eight people.
The U.S. Centers for Disease Control reported 105 cases in nine states on Monday, up from 91 cases on Sunday. The death toll rose by one overnight.  To read the rest of the article click here.

Should FDA get more power over compounding pharmacies? Read more: Should FDA get more power over compounding pharmacies?

October 8, 2012 | By Tracy Staton
With meningitis cases stacking up--and the death toll mounting, to 9 over the weekend--the list of questions is growing, too. Do doctors know enough about the source of drugs they inject? Are clinics pinching pennies too zealously? Should patients have been getting steroid injections in their spines in the first place? And, above all, should compounding pharmacies face stepped-up regulation?

Read more: here

Recent Law Review Article Discussing Federal Government's Attempt to Regulate Compounded Drug Products

A more recent law review article discussing the history of compounding and the FDA's attempt to regulate it is: Jesse M. Boodoo, Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, 36 Am. J. L. and Med. 220 (2010).  A copy can be found here.

Phederalism: The Turf War Between Pharmacies and the FDA Over Who Has Jurisdiction When It Comes to Compounded Drugs

Although an older article,Roger A. Fairfax, "Phederalism": The Regulation of Pharmacy Compounding and Two Years in the Regulatory Turf War Between Pharmacy and the Food and Drug Administration, Harvard (Winter Term 1998), does a great job of examining the history of the turf war between pharmacies and the FDA when it comes to compounded drugs through 1998.  The paper can be read here.

Canada's Policy on Compounded Drugs

To read Canada's Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051), click here

Meningitis outbreak sparks call for FDA action

Meningitis outbreak sparks call for FDA action

CDC Update for October 7, 2012: 91 Cases of Meningitis

Multi-State Meningitis Outbreak - Current Case Count

October 7, 2012 2:00 PM EDT

Persons with Meningitis Linked to Epidural Steroid Injections, by State

Persons with meningitis linked to epidural steroid injections, as of October 7, 2012:

Total case count: 91

Florida: 4 cases
Indiana: 8 cases 
Maryland: 3 cases, including 1 death
Michigan: 20 cases, including 2 deaths
Minnesota: 3 case
North Carolina: 2 cases
Ohio: 1 case
Tennessee: 32 cases, including 3 deaths
Virginia: 18 cases, including 1 death

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CDC to give update on deadly meningitis outbreak Sunday

The latest tally of cases in a widening outbreak of fungal meningitis linked to steroid injections will be made available at 2 p.m. EDT (1800 GMT) on Sunday, the Centers for Disease Control and Prevention said.

A Question in the New England Compounding Center Meningitis Case No One Seems to Be Asking: Where Did They Get Their API or Bulk Powders From?

One question that investigators may or may not be looking at, and one that news reports have not seemed to pick up on is where did New England Compounding Center buy its active pharmaceutical ingredients (api) or bulk powders or chemicals from.   Previously reported here on August 29, 2012, was this:

Alarming Report About API from China

Melanie Lee and Ben Hirschler at Reuters have written a Special Report: China's "wild east" drug store dated August 28, 2012.  This report contains alarming information about API from China.  It should be read by everyone and serves as a reminder to ask questions about the source of API used by compounders. To read the report click here.

On June 13, 2012, this was reported on the blog:

The Problems With Buying API From Foreign Sources

The Problems With Buying API From Foreign Sources

More than 80 percent of API is imported into the United States. The problem with buying API from foreign sources is that you do not know what you are getting.  For example, a pharmacetuical representative in Arizona may actually obtain its API from countries such as those in Asia or South America.  In some of these places, quality standards are very lax and counterfeit medications are more widespread and common. The identity, purity, potency and safety of drugs purchased from foreign sources is not guaranteed. It is essential that pharmacists know where the API orginated from even if they are purchasing the API from a company in the United States. Using sources of API whether the API comes from a foreign country or the United States without knowing the identity, purity, potency and safety of drugs simply to save money is not worth the exposure in liability, both civil and criminal, if a patient--human or animal--is injuried or dies from the use of these type of API.  All drugs and API distributed in the United States must comply with the Federal Food Drug and Cosmetic Act, regardless of where they are made. Note that it is illegal (with very few exceptions) to ship prescription drugs that are not approved by FDA into the US, regardless of whether the drug is legal to sell in another country. 


For more information click here.  
To see notes from an FDA seminar on imported API click here.
To review a FDA slide presentation on imported API click here.
To read prior testimony about API, click here.
To read news articles click here,  here,  here and  here
To read a 2012 report on India, click here.
To read an article published April 2012, that suggest better safeguards for imported drugs are needed, click here.
To read the FDA's report entitled Pathway to Global Product Safety and Quality, click here

Hopefully the right people are asking the right questions in the New England Compounding Center Meningitis Outbreak case
.

Waiting, worrying amid deadly meningitis outbreak

Waiting, worrying amid deadly meningitis outbreak

Epidural steroid shots debated amid meningitis scare

2:50 PM, Oct 6, 2012   

Duane Marsteller, The Tennessean

October 6. 2012 - NASHVILLE -- As authorities continue to focus on a potentially contaminated steroid as the source of a widening outbreak of fungal meningitis, some patient-safety advocates are calling for greater restrictions on the type of injection involved.

They say epidural steroid injections, like the ones given to the meningitis victims, are far too dangerous and should be limited or even banned. But those who give the injections say they are safe when done properly and note the current outbreak appears to have originated from the medicine, not the procedure itself.

The debate was being waged long before the meningitis outbreak began with the Sept. 17 death of a 78-year-old man in Nashville. Since then, at least 46 other people in Tennessee and six more states have come down with the rare and noncontagious infection, federal health officials said Friday. Five, including three in Tennessee, have died.

To read rest of the article click here.

Pennsylvania has no authority to halt tainted steroid shots from Massachusetts License not required here for out-of-state drug manufacturers

Saturday, October 06, 2012

By David Templeton, Pittsburgh Post-Gazette

Brian Kersey/Associated Press

A compounding pharmacist uses a sterile glove box to make a specialized mixture for a customer at the Martin Avenue Pharmacy in Naperville, Ill.

If a Massachusetts pharmacy had not halted its shipment of steroid shots that have killed five people, Pennsylvania could not have stopped the distribution.

Pennsylvania, Georgia and Massachusetts are the only states that don't require out-of-state drug manufacturers to be licensed before they ship drugs within their borders.

The realization became apparent as the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration, the Allegheny County Health Department and state Department of Health investigated recalled lots of the tainted pain medication -- methylprednisolone acetate -- a steroid that went to 75 facilities in 23 states, including Allegheny Pain Management in Altoona and South Hills Pain & Rehab Associates, which has facilities in Jefferson Hills, Bethel Park, Monessen and Brentwood.

The CDC said Friday that the outbreak of the rare fungal meningitis linked to the steroid shots now involves seven states. So far, no cases of illness related to the drug -- 47 sickened in addition to the five deaths -- have been identified in Pennsylvania.

"The results are real simple: The Pennsylvania Board of Pharmacy that protects citizens of the state does not have any regulatory authority of pharmacies that ship medicines into Pennsylvania," said David Miller, who is based in Philadelphia and heads the International Academy of Compounding Pharmacists.

"A guy in Pittsburgh who sells [prescription] drugs across the line in Ohio must be licensed in Ohio, but the guy in Ohio doesn't have to be licensed in Pennsylvania to sell drugs here," Mr. Miller said. "It's important in Pennsylvania that stuff is coming in from out of state and you would expect states to regulate those pharmacies."

The state Board of Pharmacy in the Department of State referred questions about drug-manufacturer licensing to the Health Department, which reported that the state Drug Device and Cosmetic Act requires that only out-of-state businesses with sales representatives within the state register with the health department if they distribute drugs or medical devices throughout the commonwealth. Those companies with no sales reps in the state can register voluntarily.

But out-of-state companies are required to be registered or licensed in the state in which they are located if they want to distribute prescription drugs here

Read more: http://old.post-gazette.com/pg/12280/1267251-114.stm#ixzz28ZcZWiIU

More Information on Meningitis Outbreak from New York Times

Scant Oversight of Drug Maker in Fatal Meningitis Outbreak

By DENISE GRADY, ANDREW POLLACK and SABRINA TAVERNISE

Published: October 6, 2012

Eddie C. Lovelace, a Kentucky judge still on the bench into his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.

Enlarge This Image

Cj Gunther/European Pressphoto Agency

The New England Compounding Center in Framingham, Mass., has had a troubled history.

Shelley Mays/The Tennessean, via Associated Press

Dr. David Reagan, the chief medical officer for the Tennessee Department of Health, spoke to reporters last week about fungal meningitis infections in Nashville, where one of the first victims in the outbreak died.

Enlarge This Image

Stephen Lance Dennee/Associated Press

Patsy Bivins, 68, of Sturgis, Ky., was notified that she might have been infected through steroids.

This fungus is blamed for the meningitis outbreak that has killed and sickened people across several states.

Instead, Judge Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the very medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.

The rising toll — 7 dead, 57 ill and thousands potentially exposed — has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states. Federal health officials said Friday that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which has a troubled history, needed to be tracked down immediately and informed of the danger.

“This wasn’t some obscure procedure being done in some obscure hospital,” said Tom Carroll, a close friend to the Lovelace family, and their lawyer. “They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,” he said, referring to the St. Thomas Outpatient Neurosurgery Center. “How does this happen?”

The answer, at least in part, is that some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University.

The outbreak has also brought new scrutiny to the widely used procedure that Judge Lovelace and millions of Americans undergo each year.

Patients most likely assumed there was strong evidence that the procedure itself works. But the Cochrane Collaboration, an international group of medical experts, reviewed the data last year and found there was “no strong evidence for or against” the injections. Patients exposed to the drug in the current outbreak may have risked their health or even their lives for an elusive goal.

A Large Demand

Over the past two decades, pain control has become a growth industry, bolstered by the worn-out knees and aching backs of baby boomers. Pain clinics began popping up around the country.

Starting in the 1990s, spinal injections for back pain, known as lumbar epidural steroid injections, skyrocketed. They have since leveled off, but the number remains high. In 2011, 2.5 million Medicare recipients had the injections, as did an equal number of younger people, according to Dr. Ray Baker, president of the International Spine Intervention Society.

Many people seek them in hopes of avoiding surgery. The injections combine a steroid and a numbing drug in an effort to soothe inflamed and irritated nerves. Patients are told they may get weeks, months or even a year of relief.

The injections created a demand for steroids, including methylprednisolone acetate, the drug that New England Compounding was making.

To be sure, many compounding pharmacies perform well, producing formulations of drugs for specialized needs. Compounders have also provided hospitals and doctors with cheaper alternatives to F.D.A.-approved drugs.

For example, they are providing a far cheaper alternative to a drug called Makena, a new brand name version of an old drug used to reduce the risk of premature births. Once the drug got F.D.A. approval, the manufacturer of Makena began charging about a hundred times more for the drug than compounders. Officials from the F.D.A. wanted to ban the pharmacy-made versions on the grounds that Makena had met the agency’s rigorous safety standards, but senior Obama administration officials, concerned about Makena’s much higher price, stepped in to halt the ban.

In recent years, compounding pharmacies have sometimes filled gaps left by shortages of drugs made by pharmaceutical companies.

“As drug shortages have become more complex and common, pharmacies are turning to external compounding companies to help them,” said Cynthia Reilly, of the American Society of Health-System Pharmacists, referring to hospital pharmacies.

Shortages may have played a role in the large purchases of the injectable steroid now under suspicion from New England Compounding. The two manufacturers of the generic version of the drug had stopped making it.

Teva halted production in 2010 when it temporarily closed its Irvine, Calif., factory after receiving a warning letter from the F.D.A. about manufacturing quality problems.

The other manufacturer, Sandoz, stopped selling the product in the United States this year, according to the company, which would not provide a reason. Sandoz has also been reprimanded by the F.D.A. for manufacturing problems.

While the F.D.A. says the drug is not in short supply, the brand name product still available may have been considered too expensive, prompting some medical practices to turn to compounding pharmacists.

PainCare, a medical practice with 12 locations in New Hampshire, turned to New England Compounding for the injectable steroid now under suspicion when its usual supplier ran out, said the company’s chief executive, Dr. Michael J. O’Connell. The company’s two main locations alone do more than 100 injections a week.

Dr. O’Connell said he preferred compounding pharmacies because they could make the drug free of an alcohol often used as a preservative in drugs manufactured by big companies that he worried could damage nerves.

In addition, Medicare and many private insurers reimburse a fixed amount for the injections, about $300, giving doctors a financial incentive to prefer the less costly compounded versions, he said. “If you are using a more expensive product, there would be less left over,” Dr. O’Connell said.

PainCare paid New England Compounding $25 for a vial containing five 80-milligram doses, he said. A similar vial of the Depo-Medrol by Pfizer, with the alcohol preservative, costs about $40 to $46, according to the Web site of Clint Pharmaceuticals, a distributor.

About 186 of PainCare’s patients were injected with the suspect product. About two dozen have had symptoms that could indicate meningitis and have come in for spinal taps. The lab results are not back, Dr. O’Connell said, but the fluid samples were clear, rather than cloudy, as they would be if infected by a fungus.

Questions of Origins

Some physicians who work in big hospitals may not even know whether the drug they use is from a compounder.

Dr. Anders Cohen, the chief of neurosurgery and spine surgery at the Brooklyn Hospital Center, said: “We ask for the medication, it’s in stock, we use it. I don’t know if it’s coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from.”

Because of the outbreak, Dr. Cohen has stopped performing spinal injections for now, and he was planning to declare a moratorium on them at his hospital until he was certain all the medicine was clean, even though his hospital is not on the list of facilities that received the potentially contaminated drug.

The size of New England Compounding appears to have reassured some doctors, who thought dealing with a large company might be safer than buying from a mom-and-pop compounder.

One pain specialist said he had heard from colleagues that the company had a good reputation and that even prestigious hospitals had used it. His practice did not buy the steroid medicine from New England Compounding but a contrast agent, a type of dye used for imaging. After he first contacted the Massachusetts company, it flew in a sales representative to meet him.

“We were impressed,” said the doctor, who spoke on the condition of anonymity because he had not yet consulted his malpractice insurer about whether he should publicly identify himself as having bought products from New England Compounding. “It seemed like big time.” The representative “assured me that all standards are being met.”

But all the dye the doctor bought from New England Compounding has had to be thrown out on the chance that it also might be contaminated, he said.

And the Massachusetts company itself has a troubled past. A series of complaints had been lodged against New England Compounding over the past decade. The State Health Department inspected in 2006. According to a warning letter sent by the F.D.A. from that year, the company was accused of illegally producing a standardized anesthetic topical cream, inappropriately repackaging a drug, and telling doctors that using an office staff member’s name was enough to put in an order, even though rules require a prescription for a particular patient.

Issues of Law

Meningitis can be caused by viruses, bacteria or fungi. Doctors say that the fungal type is the hardest to treat and devastating to patients because it can cause strokes. And indeed, some of the patients in the current outbreak have suffered strokes.

Federal inspectors last week removed samples of the suspect drug from New England Compounding to test for fungal contamination. The center, which takes in about $2.2 million a year, according to its corporate filings, is housed in a two-story brick building.

The company’s offices in suburban Boston were locked Friday, with a “no soliciting” sign on the door. The company did not respond to repeated requests for comment last week. Before it went offline, the company’s Web site said New England Compounding was licensed in all 50 states. State and federal officials said it had shipped out a prodigious amount of the potentially contaminated medicine to 75 pain clinics in 23 states.

Traditionally, the law meant compounding to be a local service in which pharmacists could tailor-make prescriptions for patients with special needs. Compounding pharmacies were not supposed to become miniature drug companies.

It is not clear how much large-scale compounding actually goes on. David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, estimated that large-scale compounders represented about 10 percent of all compounding pharmacies, but he could not say what percentage of compounded medicines they made.

As state and federal authorities pored over information about New England Compounding last week, there was little agreement among experts on whether the company broke the law by making products in bulk and shipping them around the country.

Compounding falls in a legal no man’s land, between the federal government and the states. The F.D.A. regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down, and Congress never re-established the agency’s clear authority, Professor Outterson said.

Jeff Gibbs, a lawyer in Washington who has represented compounders and drug companies, said it was unusual for a compounding pharmacy to produce large quantities of a drug that is commercially available. Policies of the F.D.A. were more concerned about compounders’ making drugs that are already approved and on the market, and not so much about compounders’ producing large volumes of medicine, he said.

But Sheldon T. Bradshaw, a lawyer in Washington who was chief counsel for the F.D.A. from 2005 to 2007, said large-scale compounders often behave like manufacturers, complete with sales teams that market their products to doctors. And they do not have to abide by the F.D.A.’s regulations, which require that problems with products be reported to the agency. In effect, he said, the companies are circumventing the regulatory process.

He contended that the F.D.A. could invoke the Food, Drug and Cosmetic Act of 1938, which makes it a criminal act “to introduce into interstate commerce an unapproved drug.” That is what New England Compounding’s products would most likely be considered because the company was doing more than traditional compounding, yet had not obtained a new drug approval, something that large drug makers spend millions of dollars and years to get. He said the agency has often sent letters to producers telling them to stop, and they usually comply, knowing there might be criminal charges if they do not.

“Some of these companies are just setting up big manufacturing shops in the guise of traditional compounding and making drugs that are, for the most part, commercially available,” Mr. Bradshaw said. “Instead of making fake Rolexes, they are making fake drugs.”

Jess Bidgood and Sheelagh McNeill contributed reporting.

A version of this article appeared in print on October 7, 2012, on page A1 of the New York edition with the headline: Scant Oversight of Drug Maker in Fatal Outbreak.

http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html?smid=pl-share

All New England Compounding Pharmacy Compounded and Distributed Products Recalled

Published: Saturday, Oct. 06, 2012 / Updated: Saturday, Oct. 06, 2012 08:53 PM

New England Compounding Center Issues Voluntary Nationwide Recall of All Products

FRAMINGHAM, Mass. --

New England Compounding Pharmacy, Inc. dba New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured. While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure.
Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that appears at our Website: www.neccrx.com. A complete list of all products subject to this recall can be accessed at the website.
NECC is notifying its customers of this recall by fax. Clinics, hospitals and healthcare providers that have product which has been recalled should stop using the product immediately, retain and secure the product, and follow instructions contained in the fax notice.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm¹
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm². Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source is found here.

7 dead and 64 in nine states sick as meningitis outbreak grows

Seven dead as meningitis outbreak grows

Posted on October 7, 2012 by The Extinction Protocol

October 7, 2012 – HEALTH – The death toll from an outbreak of fungal meningitis linked to contaminated steroid injections has risen to seven, the Centers for Disease Control and Prevention said Saturday. The total number of cases has also grown to 64 people in nine states, the CDC said.   To read rest of article click here.

What All The News Reports Are Missing in the New England Compounding Center Meningitis Outbreak

This new article, 47 patients linked to meningitis infections, from CNN notes that nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.  However, there are a number of things that the reporters fail to point out.    Some articles cite the tragic Franck's case involving the 21 dead horses.  The Food and Drug Administration attempted to stop Franck in that case but a district court judge in Florida said it did not have any jurisdiction over veterinary compounding.  The FDA appeal to the 11th Circuit Federal Court of Appeal.  The case will be argued next month.  In the mean time Franck was at it again, causing eye infections from human drug compounds.  No one can fault the FDA in that case because the FDA had tried to stop Franck.  The state board of pharmacy imposed a fine for the dead horses.  The insurance companies are now suing Franck to get back their money.

Other articles fail to cite the end result of the Apothecure and Gary D. Osborn case, where human compounded drugs resulted in deaths.  In that case the federal government prosecuted Apothecure and Gary D. Osborn after all the civil lawsuits.  Apothecure and Gary D. Osborn pled guilty but were recently sentenced to no jail time and a $100,000 fine was imposed on both-- not much for the harm caused.  But again the FDA and the United States Attorney's Office in the Northern District of Texas did take action.  They did try to stop the bad compounders.

But as my previous post noted, we must have compounded drugs. No one seems to be pointing out that a lot higher percentage of compounded drugs are used on animals. That is so evident in the veterinary world where most of the drugs used for animals are either human drugs or most likely compounded drugs made special for a specific animal.    What must continue to be stressed is that there is a place for compounded drugs and that there are good compounding pharmacies and pharmacists out there who do everything within their powers to follow all the rules and regulations, who have compliant sterile rooms, who spend the money to test to make sure the compound is what it is suppose to be.  Tragic as the New England Compounding Center meningitis outbreak is hopefully the world of compounded drugs for both humans and animals will become a better, safer environment, not one that no longer exists.

Update:  News articles are now reporting on the Apothecure and Gary D. Osborn case.  Still not much coverage on why we must have compounded drugs in the United States.  See previous post for a list of reasons compounded medications for animals and humans are essential.