The New Old Age Blog: The Ex-Wives Club

Weather permitting, Kappy Lundy and Barbara Thompson are heading out to Vancouver, Wash., on Saturday night to have a holiday dinner with the parents of their daughter’s husband.

Yes, these women both mothered the same children — now grown and with children of their own. Ms. Lundy is their biological parent; Ms. Thompson is the stepmother who married their father after he and Ms. Lundy divorced.

But that doesn’t really begin to describe their relationship. Over more than 40 years, these two have been friends and what they call “wife-in-laws,” in addition to moms-in-tandem. Now, they’re so close they feel like sisters, they say.

There’s yet another dimension to this relationship that makes it so unusual: Ms. Lundy, who is 71, has become a caregiver for Ms. Thompson, who’s 67 and was given a diagnosis of mild cognitive impairment in 2009.

One wife caring for another, through thick and through thin – think about that. It’s another example of how the new old age is spawning unusual — and creative — alliances.

Ms. Lundy went with Ms. Thompson to eight months of classes on memory loss offered by the Alzheimer’s Association chapter in Portland, Ore., where the two women live. And now they go together to monthly meetings of the Wild Bunch, a group of people with dementia and their caregivers who’ve come together to provide each other emotional support. (More on that group to come in a future post.)

Ms. Lundy talks to Ms. Thompson every day and tries to get together with her once a week.

“We’re just really good friends, and we want to know what’s going on, what are you doing, like everybody else,” said Ms. Thompson, who moved into an independent living facility in Portland nearly a year ago, after Ms. Lundy helped pack up her previous apartment.

Ms. Lundy, who lives across town, about 20 minutes away, said: “We’ll go to happy hour together and have a little toddy and maybe a nice meal. And crack up – she makes me laugh.”

Both women grew up in Eugene, Ore., but became friends later, after they moved to Portland in their 20s. Their favorite haunt was the Goose Hollow Inn, a tavern where artists, architects and writers would congregate. Ms. Lundy and her husband began to socialize regularly with Ms. Thompson and her first husband.

“She’s full of life and fun – a gypsy at heart,” is how Ms. Thompson describes Ms. Lundy.

“She’s funny and smart and a really good listener,” is how Ms. Lundy describes Ms. Thompson.

When Ms. Lundy’s marriage to Phil Thompson — a handsome bear of a man, with a charismatic personality and an artistic sensibility — began falling apart, both members of the couple turned to their friend Barbara for support. “She listened to me and my anger, and she listened to him about how he was hurting,” says Ms. Lundy, who was separated from her husband for a year before the divorce was official.

There were no hard feelings when Phil’s feelings toward Barbara turned romantic, Ms. Lundy says. But she didn’t see the couple much during subsequent years of work and travel abroad. During those years, her children, Jessica and David, stayed with their father in Portland.

Eventually, Ms. Lundy came home and was invited to holidays at the Thompson house. She grew close to Barbara again and let go of negative feelings toward her former husband, she said. Over time, they became bound together as family.

“It’s incredible,” their daughter said. “They’re just really caring for each other and not threatened by each other.

“My dad got a big kick out of it and would always introduce them as ‘my wives.’”

When Phil Thompson died in August 2008, both women were at his bedside. And when Ms. Thompson started having memory problems months later, Ms. Lundy was one of the first to notice. “We could see she wasn’t remembering things, but she said, ‘This is my grief,’” Ms. Lundy recalled. It became clear something else might be going on as problems persisted and a doctor’s evaluation yielded the mild cognitive impairment diagnosis.

Ms. Thompson described her reaction to that information: “It was scary. Very scary. I didn’t know if it meant the end of my freedom, of my ability to just live my own life.”

For her part, Ms. Lundy said: “The hardest thing for me from the very beginning was to see my party pal and my dear, dear friend changing. It was very frustrating to me. And very hurtful. I wanted to support her. But sometimes I didn’t have the patience. Because, you know, she wasn’t acting like Barbara. It’s taken a while, but slowly, slowly, slowly and surely, I’ve accepted that this is who Barbara is.”

Ms. Lundy isn’t the only caregiver for Ms. Thompson: Jessica and David, her stepchildren, and two close friends also help out, as needed.

For Ms. Lundy, the uncertainty associated with her friend’s mild cognitive impairment diagnosis is hard to live with. Will it progress to dementia? Will it stay stable, or even get better? The doctor can’t say, and “all that not-knowing business is unsettling,” she said.

Becoming a caregiver has “made our friendship even stronger, I think,” Ms. Lundy says. “We’re closer now. Even though we’ve been friends for years and years, I never felt responsible for her before.”

For Ms. Thompson, what’s hardest is living alone after nearly 30 years of being married to Phil and worrying about losing her independence — notably, her ability to continue driving.

“I feel isolated with the disease,” she said. “And being alone in a new apartment with lots of strangers here has been a little difficult.”

“I’m very grateful to Kappy,” Ms. Thompson said. “I didn’t used to feel that she would be this way. She was always doing her own thing. But she has definitely reached out, beyond what most people would do.”

On Christmas the two women will be at Jessica’s house, arriving at around noon, after the grandchildren have opened their presents, and staying through the late afternoon. After the holidays, Ms. Lundy says she plans to take Ms. Thompson out more often and “have a couple of beers and a laugh and be happy and just be Barbie and Kappy,” two old friends, enjoying each other’s company.

This is the one of the most unusual caregiving relationships I know of. It reaffirms what I’ve been told several times: You never know who will end up being there for you when you need help. Sometimes the people we expect will care for us don’t, and others step forward. Has that been your experience?

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DealBook: Former SAC Trader Is Indicted

A former SAC Capital Advisors portfolio manager was indicted on Friday on securities fraud and conspiracy charges in a case that federal prosecutors have called the most lucrative insider trading scheme ever uncovered.

A federal grand jury in Manhattan indicted the former portfolio manager, Mathew Martoma, a month after the government arrested on him charges that he used inside tips about a clinical drug trial to help SAC earn profits and avoided losses totaling $276 million.

While Stamford, Conn.-based SAC has been touched by several insider trading cases in recent years, there is heightened attention surrounding the Martoma prosecution. For the first time, the government has tied questionable trades to Steven A. Cohen, the billionaire owner of SAC.

“Though disappointing, today’s events come as no surprise,” Mr. Martoma’s lawyer, Charles A. Stillman, said in a statement. “The simple fact is that Mathew Martoma did not trade on inside information, is innocent of all these charges, and we look forward to his ultimate vindication.”

Before Friday’s indictment, there had been speculation that the government, before formally presenting evidence to a grand jury, was trying to gain Mr. Martoma’s cooperation in building a case against Mr. Cohen. Mr. Martoma has rebuffed several earlier efforts by the authorities to enter into plea talks and implicate his boss.

Mr. Cohen has not been charged with any wrongdoing, and a spokesman for SAC has said that he believes that he and SAC have at all times acted appropriately. The Securities and Exchange Commission, which brought a parallel civil action against Mr. Martoma, has warned SAC that it is likely to filed a fraud lawsuit against the firm related to the Martoma case.

Hedge Fund Inquiry

Mr. Martoma, 38, is set to appear in Federal District Court in Manhattan on Jan. 3 for his arraignment, at which time he will enter a plea. The case was assigned to Judge Paul Gardephe, a former federal prosecutor who assumed his seat on the bench in 2008 after an appointment by President George W. Bush.

The government says that Mr. Martoma obtained secret, negative information from a doctor about clinical trials of an Alzheimer’s drug being developed by the pharmaceutical companies Elan and Wyeth. He then, prosecutors say, had a 20-minute telephone conversation with Mr. Cohen.

A day after the phone call, SAC sold $700 million in Elan and Wyeth stock and made a large negative bet on the companies. The companies’ shares plummeted after they announced the disappointing trial results, and SAC booked big profits.

The doctor, Sidney Gilman, is cooperating with prosecutors and has agreed to testify against Mr. Martoma. The government gave Dr. Gilman a non-prosecution agreement, meaning they will not bring criminal charges against him. Such an agreement is highly unusual, legal experts say, and is being used as a pressure point on Mr. Martoma in an effort to get him to “flip” against Mr. Cohen.

Before coming to New York for his arraignment, Mr. Martoma will be spending the holidays with his wife and three young children at home, in Boca Raton, Fla.

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Huge Savings With MyBatua Season’s Sale






The online Islamic clothing store MyBatua.com brings more reasons to smile. The Store announces huge discounts and assured gifts on every purchase of women Abayas, kurtis and Jibabs.


(PRWEB) December 21, 2012






MyBatua.com has extended its seasonal sale on Islamic clothing range for a fortnight to appreciate the huge response of buyers. Being one of the most renowned stores for a vibrant range of Islamic clothing range, MyBatua has announced discounts up to 60% on modern, contemporary, fashionable and exclusive Islamic apparel for men and women.


The online store offers a huge collection of Jibabs, kurtis, abayas and Hijabs for customers, with the choice of customization. All the clothing items displayed at the sale are designed to reflect exclusive style statements of customers. Islamic outfits at MyBatua are available with contemporary and very stylish looks. Jilbabs and Abaya at the store are also made from natural fabric and with contemporary texture.


At http://www.mybatua.com visitors may choose from an extensive range of hijabs available in different styles, plain solid colors, fantastic design and attractive ones for joyful events. Like their name they are very simple to put on without any wrapp or Hijab pin. The store is well-known for its best quality beautiful hijabs and Abayas with an inexpensive price tag.


The best part of the season sale at the store is the availability of the finest range of ethnic clothing for a diverse array of women buyers who never compromise on quality and style. The store features a diverse variety of modest Women’s clothing items that range from conventional Abayas to custom Hijabs designed with finest craftsmanship.


Apart from a pretty good collection of regular and Plus sizes of Jibabs, Abayas and Hijab, customers also get an option to customize clothes without any additional cost. With every purchase at http://www.mybatua.com seasonal sale, customers find huge cash discounts and assured gifts to turn their shopping spree rewarding and a never before experience. MyBatua range comes with free shipping and hassle free delivery to the customers worldwide.    


MyBatua a leading online store for clothing and accessories has now become a one stop shopping place for Islamic fashion clothing. It is catering to all needs of online shoppers for Abayas, Jilbabs, Hijabs, Sherwanis and variety of accessories including brooches and unique handbags suitable for all occasions and weddings.


Amrish Goel
Mybatua.com
+918826009522
Email Information


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Egypt’s Chief Prosecutor Retracts His Resignation





CAIRO — Egypt’s chief prosecutor withdrew his resignation on Thursday, just days after submitting it. The move was the latest bizarre turn in a complicated three-way struggle among the new Islamist president, the institutions of the old government and the president’s opposition in the streets.




President Mohamed Morsi appointed the prosecutor, Talaat Ibrahim Abdullah, in a Nov. 22 decree that set off protests across the country and prompted a political crisis because it also sought to exempt presidential edicts from judicial scrutiny.


Mr. Abdullah’s role drew more critical attention after a night of deadly violence between Mr. Morsi’s Islamist supporters and their opponents outside the presidential palace this month. A local Cairo prosecutor accused Mr. Abdullah and Mr. Morsi’s chief of staff of pressing for legal action without adequate evidence against a group of opposition protesters that the Islamists had captured during the battle. When the pressure was rebuffed, the local prosecutor said that Mr. Abdullah had briefly sought to punish him by transferring him to a remote town in Upper Egypt.


Other prosecutors accused the Morsi government of trying to turn law enforcement into a political tool, and on Monday they staged an angry protest at the door of the high court building where Mr. Abdullah works. Dozens of riot police officers stood guard. After hours of confrontations on the street and in his office, Mr. Abdullah wrote out a letter of resignation, and the crowd left in triumph.


In response, Mr. Morsi’s Islamist supporters denounced the forced resignation as mob rule. “What street thugs do these days,” was how Mr. Morsi’s party, the political arm of the Muslim Brotherhood, described it in a statement. The party also accused the prosecutors of brandishing weapons to intimidate Mr. Abdullah. Witnesses said they did see not any weapons.


If groups of public employees were allowed to force out their bosses, “the whole country would descend into total chaos, governed by the law of the jungle,” the party said. It called judges who had opposed the appointment “enemies of the revolution” and “enemies of the people” because they favored the return of the former chief prosecutor, appointed by Hosni Mubarak and faulted for failing to pursue his cronies.


Evidently pushed by the Morsi government and its supporters not to resign, Mr. Abdullah said Thursday that his earlier resignation had been illegitimate because it occurred “under pressure” from the angry lawyers outside his office, Egyptian state news media reported.


The reversal is likely to raise new alarms about Mr. Morsi’s efforts to tighten his grip on power, days before the conclusion on Saturday of a two-phase referendum on an Islamist-backed draft constitution.


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Barring setback, Redskins' RG3 looks good to go


ASHBURN, Va. (AP) — Robert Griffin III looks good to go.


The Washington Redskins rookie had a full practice Thursday for the second straight day as the team prepares for this week's game against the Philadelphia Eagles.


"I like what I see," coach Mike Shanahan said. "If there is no setback, he should be ready to go."


Griffin missed Sunday's win over the Cleveland Browns with a sprained right knee. On Wednesday, he had his first full practice since the injury, and coaches and doctors were eager to see how the knee would respond.


"There wasn't a setback today, so that's a good sign," Shanahan said.


Also Thursday, right tackle Tyler Polumbus remained unable to practice as he recovers from a concussion. Linebacker London Fletcher (sprained left ankle), linebacker Lorenzo Alexander (right shoulder) and defensive end Stephen Bowen (torn biceps) were limited, and linebacker Rob Jackson returned to practice after the birth of his baby girl.


___


Online: http://pro32.ap.org/poll and http://twitter.com/AP_NFL


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The Consumer: Grapefruit and Drugs Often Don't Mix

The patient didn’t overdose on medication. She overdosed on grapefruit juice.

The 42-year-old was barely responding when her husband brought her to the emergency room. Her heart rate was slowing, and her blood pressure was falling. Doctors had to insert a breathing tube, and then a pacemaker, to revive her.

They were mystified: The patient’s husband said she suffered from migraines and was taking a blood pressure drug called verapamil to help prevent the headaches. But blood tests showed she had an alarming amount of the drug in her system, five times the safe level.

Did she overdose? Was she trying to commit suicide? It was only after she recovered that doctors were able to piece the story together.

“The culprit was grapefruit juice,” said Dr. Unni Pillai, a nephrologist in St. Louis, Mo., who treated the woman several years ago and later published a case report. “She loved grapefruit juice, and she had such a bad migraine, with nausea and vomiting, that she could not tolerate anything else.”

The previous week, she had been subsisting mainly on grapefruit juice. Then she took verapamil, one of dozens of drugs whose potency is dramatically increased if taken with grapefruit. In her case, the interaction was life-threatening.

Last month, Dr. David Bailey, a Canadian researcher who first described this interaction more than two decades ago, released an updated list of medications affected by grapefruit. There are now 85 such drugs on the market, he noted, including common cholesterol-lowering drugs, new anticancer agents, and some synthetic opiates and psychiatric drugs, as well as certain immunosuppressant medications taken by organ transplant patients, some AIDS medications, and some birth control pills and estrogen treatments. (The full list is online; your browser must be configured to handle PDF files.)

“What drove us to write this paper was the number of new drugs that have come out in the last four years,” said Dr. Bailey, a clinical pharmacologist at the Lawson Health Research Institute, who first discovered the interaction by accident in the 1990s.

How often such reactions occur, however, and how often they are triggered in people consuming regular amounts of juice is debated by scientists. Dr. Bailey believes many cases are missed because doctors don’t think to ask if patients are consuming grapefruit or grapefruit juice.

Even if such incidents are rare, Dr. Bailey argued, they are predictable and entirely avoidable. Many hospitals no longer serve juice, and some prescriptions carry stickers warning patients to avoid grapefruit.

“The bottom line is that even if the frequency is low, the consequences can be dire,” he said. “Why do we have to have a body count before we make changes?”

For 43 of the 85 drugs now on the list, consumption with grapefruit can be life-threatening, Dr. Bailey said. Many are linked to an increase in heart rhythm, known as torsade de pointes, that can lead to death. It can occur even without underlying heart disease and has been seen in patients taking certain anticancer agents, erythromycin and other anti-infective drugs, some cardiovascular drugs like quinidine, the antipsychotics lurasidone and ziprasidone, gastrointestinal agents cisapride and domperidone, and solifenacin, used to treat overactive bladders.

Taken with grapefruit, other drugs like fentanyl, oxycodone and methadone can cause fatal respiratory depression. The interaction also can be caused by other citrus fruits, including Seville oranges, limes and pomelos; one published case report has suggested that pomegranate may increase the potency of certain drugs.

Older people may be more vulnerable, because they are more likely to be both taking medications and drinking more grapefruit juice. The body’s ability to cope with drugs also weakens with age, experts say.

Under normal circumstances, the drugs are metabolized in the gastrointestinal tract, and relatively little is absorbed, because an enzyme in the gut called CYP3A4 deactivates them. But grapefruit contains natural chemicals called furanocoumarins, that inhibit the enzyme, and without it the gut absorbs much more of a drug and blood levels rise dramatically.

For example, someone taking simvastatin (brand name Zocor) who also drinks a small 200-milliliter, or 6.7 ounces, glass of grapefruit juice once a day for three days could see blood levels of the drug triple, increasing the risk for rhabdomyolysis, a breakdown of muscle that can cause kidney damage.

Estradiol and ethinyl estradiol, forms of estrogen used in oral contraceptives and hormone replacement, also interact with grapefruit juice. In one case in the journal Lancet, a 42-year-old woman taking the birth control pill Yaz developed a very serious clot that threatened her leg several days after she started eating just one grapefruit a day, said Dr. Lucinda Grande, a physician in Lacey, Wash., and an author of the case report.

But Dr. Grande also noted that the patient had other risk factors and the circumstances were unusual. “The reason we published it as a case report was because it was so uncommon,” she said. “We need to be careful not to exaggerate this.”

Some drugs that have a narrow “therapeutic range” — where having a bit too much or too little can have serious consequences — require vigilance with regard to grapefruit, said Patrick McDonnell, clinical professor of pharmacy practice at Temple University. These include immunosuppressant agents like cyclosporine that are taken by transplant patients to prevent rejection of a donor organ, he said.

Still, Dr. McDonnell added, most patients suffering adverse reactions are consuming large amounts of grapefruit. “There’s a difference between an occasional section of grapefruit and someone drinking 16 ounces of grapefruit juice a day,” he said.

And, he cautioned, “Not all drugs in the same class respond the same way.” While some statins are affected by grapefruit, for instance, others are not.

Here is some advice from experts for grapefruit lovers:

¶ If you take oral medication of any kind, check the list to see if it interacts with grapefruit. Make sure you understand the potential side effects of an interaction; if they are life-threatening or could cause permanent injury, avoid grapefruit altogether. Some drugs, such as clopidogrel, may be less effective when taken with grapefruit.

¶ If you take one of the listed drugs a regular basis, keep in mind that you may want to avoid grapefruit, as well as pomelo, lime and marmalade. Be on the lookout for symptoms that could be side effects of the drug. If you are on statins, this could be unusual muscle soreness.

¶It is not enough to avoid taking your medicine at the same time as grapefruit. You must avoid consuming grapefruit the whole period that you are on the medication.

¶In general, it is a good idea to avoid sudden dramatic changes in diet and extreme diets that rely on a narrow group of foods. If you can’t live without grapefruit, ask your doctor if there’s an alternative drug for you.


Readers may submit comments or questions for The Consumer by e-mail to consumer@nytimes.com.

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RIM Posts Smaller Than Expected Loss as Subscriber Base Slips



(Reuters) - Research In Motion reported a smaller-than-expected quarterly loss on Thursday, but recorded the first-ever drop in its subscriber base barely a month before the crucial launch of the new BB10 smartphone line.


Excluding one-time items related to restructuring and other issues, the struggling BlackBerry maker reported a loss of $114 million or 22 cents a share.


Analysts, on average, had forecast a loss of 35 cents a share, according to Thomson Reuters I/B/E/S.


Waterloo, Ontario-based RIM, which hopes to reinvent itself and revive its fortunes with the launch of the Blackberry 10 line next month, reported fiscal third-quarter net income of $9 million, or 2 cents a share. That compared with a year-ago profit of $265 million, or 51 cents.


The company said its subscriber base in the quarter fell to about 79 million from about 80 million in the period ended September 1.


(Reporting by Euan Rocha; Editing by Janet Guttsman)


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Google launches ‘scan and match’ music service






LOS ANGELES (AP) — Google is turning on a “scan and match” service for Google Music users to store copies of their songs online, offering for free what Apple charges $ 25 a year for.


The service, which launched Tuesday, cuts uploading time for those who want to save their music libraries online. It scans a user’s computer and gives them online access to the songs it finds, as long as they match the songs on its servers. Otherwise, it will upload songs to a user’s online locker.






The service is similar to Apple Inc.‘s iTunes Match, which includes online storage for 25,000 songs. Google Inc. allows storage for 20,000 songs and allows users to re-download the songs only at the same quality as they were at previously. Apple upgrades songs to iTunes quality.


Amazon runs a similar matching and uploading service called Cloud Player. It costs $ 25 a year for 250,000 songs. A free version is limited to 250 songs.


Google is still a fledgling entrant into music sales since debuting its store in November 2011, though it expects to benefit from the hundreds of millions of devices that use its Android operating system on mobile devices.


According to the NPD Group, Apple accounted for 64 percent of U.S. music sales online, followed by Amazon at 16 percent. Google has no more than 5 percent, according to NPD. Other services make up the rest.


Google had sold songs at a discount at the start, but that is less so the case now. For example, it was selling the top-ranked Bruno Mars song “Locked Out of Heaven” for $ 1.29 on Wednesday, the same as iTunes, and above the 99 cents on Amazon. But its album price was lower at $ 10.49 versus $ 10.99 at both iTunes and Amazon.


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Army Seeks Death Penalty for Bales in Afghan Massacre





SEATTLE — The United States Army will seek the death penalty against Staff Sgt. Robert Bales, who is accused of killing 16 civilians in Afghanistan, officials said on Wednesday.




Sergeant Bales’s court-martial will consider 16 counts of premeditated murder, six counts of attempted murder and seven counts of assault, among other charges, but no trial date was set.


The Army has charged that Sergeant Bales, 39, who was serving his fourth combat tour, walked away from a remote outpost in southern Afghanistan and shot and stabbed members of several families in an ambush in two villages in the early morning hours of March 11. At least nine of the people he is accused of killing were children.


Prosecutors at a week of pretrial hearings in early November at Joint Base Lewis-McChord, where Sergeant Bales was stationed, suggested that he had acted in deliberate fury, perhaps in revenge for a fellow soldier who had lost a leg in a bomb attack. Defense lawyers said evidence presented in the hearing about Sergeant Bales’s use of alcohol, steroids and sleeping aids complicated the picture of his mental state.


Sergeant Bales’s lead lawyer, John Henry Browne, called the Army’s decision to move ahead on what appears to be a fast track of prosecution “understandable but totally irresponsible.”


“The Army is trying to take the focus off the failures of the Army, which are substantial,” Mr. Browne said in a telephone interview on Wednesday. He said that Sergeant Bales, who has pleaded not guilty, had post-traumatic stress and a concussive head injury, but that the Army sent him anyway “to one of the more intense battlegrounds of Afghanistan, on his fourth deployment."


For both sides the legal path ahead promises to be long and winding.


Since the system for military prosecutions in capital cases was revised in 1984, 16 men have been sentenced to death and five are on death row. Nine of those sentences were set aside on appeal and two were commuted to life in confinement.


The rules require the president to approve any death sentence, and that has happened only once in any of the 16 cases, in 2008, under President George W. Bush. That case was then tied up in appeals. No military death sentence has been carried out since 1961.


For capital punishment to be imposed, the Army said in a statement, the court-martial panel must unanimously find Sergeant Bales guilty, with at least one aggravating factor that “substantially” outweighs any extenuating or mitigating circumstances.


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F.D.A. and States Meet About Regulation of Drug Compounders


Mary Calvert/Reuters


Margaret Hamburg, the F.D.A. commissioner, testified on the fungal meningitis outbreak before Congress in November. Dr. Hamburg addressed the need for greater federal oversight of large compounding pharmacies, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge.







SILVER SPRING, Md. – The Food and Drug Administration conferred with public health officials from 50 states on Wednesday about how best to strengthen rules governing compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted pain medication produced by a Massachusetts pharmacy.




It was the first public discussion of what should be done about the practice of compounding, or tailor-making medicine for individual patients, since the F.D.A. commissioner, Dr. Margaret Hamburg, last month testified in Congress about the need for greater federal oversight of large compounding pharmacies. So far, 620 people in 19 states have been sickened in the outbreak, and 39 of them have died.


Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how they see the federal role. Large-scale compounding has expanded dramatically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.


“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws have not kept pace. “We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems.”


Under current law, compounders are not required to give the F.D.A. access to their books, and about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, though compounders are only a small part of the agency’s regulatory responsibilities.


The F.D.A.'s critics argue that the agency already has all the legal authority it needs to police compounders. They say many compounders have been operating as major manufacturers, shipping to states across the country, and that the F.D.A. should be using its jurisdiction over manufacturers to regulate those companies’ activities.


“There should be one uniform federal standard that is enforced by one agency – the F.D.A.,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, a nonprofit consumer organization, who has been a critic of the agency’s approach. “They have been lax in enforcing that standard.”


But Dr. Hamburg contends that the distinction is not so simple. Lumping large compounders in with manufacturers would mean they would have to file new drug applications for every product they make, a costly and time-consuming process that is not always necessary for the products they make, which may include IV feeding tube bags. Dr. Hamburg has proposed creating a new federal oversight category for large-scale compounders, separate from manufacturers.


“What concerns me is the idea that we could assert full authority over some of these facilities as though they were manufacturers, as though there were an on-off, black-white option,” Dr. Hamburg said. “That is a heavy-handed way to regulate a set of activities that can make a huge positive difference in providing necessary health care to people.”


Large-scale compounders play an important role in the health care supply chain when they produce quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals. Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.


Carmen Catizone, head of the National Association of Boards of Pharmacy, said states are not equipped to regulate the large-scale compounders and that the F.D.A. needs to find a middle path for regulating them.


“Either hospitals are not going to like the solution, or the manufacturers aren’t going to like the fact that these guys get a shorter path,” he said. “But something’s got to give.”


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