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F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer

September 6, 2013 by

In a clinical trial, Abraxane prolonged the lives of patients by a little less than two months on average. Pancreatic specialists have said the drug was a welcome, if modest, advance against a disease that is extremely tough to treat.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” Dr. Richard Pazdur, director of cancer drugs for the F.D.A., said in a statement on Friday. “In these situations, and in situations where the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

There will be about 45,000 new cases of pancreatic cancer diagnosed in the United States this year and about 38,000 deaths, making it the fourth-leading cause of cancer death.

Patients with metastatic pancreatic cancer typically live only half a year. For years, researchers have tried to improve that by adding drugs to the standard treatment, gemcitabine, but without notable success.

Abraxane did provide a statistically significant improvement in survival. In its main clinical trial, patients who received Abraxane and gemcitabine lived a median of 8.5 months, compared to 6.7 months for those receiving only gemcitabine.

Abraxane will compete with Folfirinox, a combination of four generic drugs. Folfirinox appears to extend survival by a greater amount than Abraxane, but doctors say it is harder to tolerate and administer.

Abraxane is a novel form of paclitaxel, also known by the brand name Taxol. In Abraxane, the paclitaxel is bound in tiny particles to albumin, a human protein. That is said to enhance delivery of the drug to the tumor and reduce side effects.

Still, Abraxane can depress levels of white blood cells and platelets and raise the risk of bacterial bloodstream infections and lung inflammation, the F.D.A. said.

Abraxane was approved to treat breast cancer in 2005 and lung cancer in 2012. Sales last year were $427 million. Celgene’s total revenue that year was $5.5 billion, mostly from the multiple myeloma drug Revlimid.

Geoffrey Meacham, a biotechnology analyst at J. P. Morgan, said in a note on Friday that he expected Abraxane to “rapidly become the standard of care” for pancreatic cancer. He said sales for that use could eventually exceed $750 million annually.

Celgene said the drug would cost $6,000 to $8,000 a month.

Abraxane was developed by Abraxis BioScience, which Celgene acquired in 2010 for $2.9 billion, in addition to a security entitling holders to possible future payments. With Friday’s approval, Celgene will pay $300 million to those holders.

Article source: http://www.nytimes.com/2013/09/07/business/fda-approves-drug-for-late-stage-pancreatic-cancer.html?partner=rss&emc=rss

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Supreme Court to Hear Monsanto Seed Patent Case

February 15, 2013 by Leave a Comment

Yet the 75-year-old farmer from southwestern Indiana will face off Tuesday against the world’s largest seed company, Monsanto, in a Supreme Court case that could deal a huge blow to the future of genetically modified crops, and also affect other fields from medical research to software.

At stake in Mr. Bowman’s case is whether patents on seeds — or other things that can self-replicate – extend beyond the first generation of the products.

It is one of two cases before the Supreme Court related to the patenting of living organisms, a practice that has helped give rise to the biotechnology industry but which critics have long considered immoral. The other case, involving a breast cancer risk test from Myriad Genetics, will determine whether human genes can be patented. It is scheduled to be heard on April 15.

Monsanto says that a victory for Mr. Bowman would allow farmers to essentially save seeds from one year’s crop to plant the next year, eviscerating patent protection. In Indiana, it says, a single acre of soybeans can produce enough seeds to plant 26 acres the next year.

Such a ruling would “devastate innovation in biotechnology,” the company wrote in its brief. “Investors are unlikely to make such investments if they cannot prevent purchasers of living organisms containing their invention from using them to produce unlimited copies.”

The decision might also apply to live vaccines, cells lines and DNA used for research or medical treatment, and some types of nanotechnology.

Many organizations have filed friend-of-the court briefs in support of Monsanto’s position — universities worried about incentives for research, makers of laboratory instruments, and some big farmer groups like the American Soybean Association, which say seed patents have spurred crop improvements. The Department of Justice is also supporting Monsanto’s argument.

BSA/The Software Alliance, which represents companies like Apple and Microsoft, said in a brief that a decision against Monsanto might “facilitate software piracy on a broad scale” because software can be easily replicated. But it also said that a decision that goes too far the other way could make nuisance software patent infringement lawsuits too easy to file.

Some critics of biotechnology say that a victory for Mr. Bowman could weaken what they see as a stranglehold that Monsanto and some other big biotech companies have over farmers, which they say has led to rising seed prices and the lack of high-yielding varieties that are not genetically engineered.

Patents have “given seed companies enormous power, and it’s come at the detriment of farmers,” said Bill Freese, science policy analyst for the Center for Food Safety, which co-authored a brief on the side of Mr. Bowman. “Seed-saving would act as a much needed restraint on skyrocketing biotech seed prices.”

Farmers who plant seeds with Monsanto’s technology must sign an agreement not to save the seeds, which means they must buy new seeds every year.

Monsanto has a reputation for vigorously protecting its intellectual property.

The Center for Food Safety, which has tracked the cases, said Monsanto has filed more than 140 patent infringement lawsuits involving 410 farmers and 56 small farm businesses, and has so far received $23.5 million in recorded judgments. The organization says there are numerous other cases in which farmers settle out of court or before a suit is filed.

Monsanto says it must stop infringers to be fair to the vast majority of farmers who do pay to use its technology.

But Monsanto typically exercises no control over soybeans or corn once farmers sell their harvested crops to grain elevators, which in turn sell them for animal feed, food processing or industrial use.

Article source: http://www.nytimes.com/2013/02/16/business/supreme-court-to-hear-monsanto-seed-patent-case.html?partner=rss&emc=rss

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Two Drugs Appear to Delay Progression of Breast Cancer

December 8, 2011 by Leave a Comment

Both drugs, pertuzumab from Genentech and everolimus from Novartis, also showed signs in clinical trials that they could prolong lives, though researchers said it was too early to say that definitively.

Results of the studies, which were sponsored by the companies, are being presented this week at the San Antonio Breast Cancer Symposium and were published online Wednesday in The New England Journal of Medicine.

Pertuzumab is designed to complement Genentech’s big-selling drug Herceptin for the roughly 20 percent of breast cancer patients whose tumors have elevated levels of a protein called Her2. Both pertuzumab and Herceptin block the action of the protein but in different ways.

In a late-stage clinical trial involving 808 patients, women randomly chosen to receive pertuzumab, Herceptin and the chemotherapy drug docetaxel went a median of 18.5 months before their tumors worsened or they died, a measure known as progression-free survival. That was significantly longer than the 12.4 months for those who received a placebo, Herceptin and docetaxel.

“We have an improvement in progression-free survival that is six months,” Dr. José Baselga, chief of hematology and oncology at Massachusetts General Hospital, said in an interview. “That’s huge. By any criteria we want to analyze, this is clinically meaningful.”

Dr. Baselga was a principal investigator in the studies of both pertuzumab and everolimus and has been a paid consultant for Genentech and Novartis.

He said the addition of pertuzumab did not increase cardiac dysfunction, a worrisome side effect of Herceptin.

Genentech and its parent company, Roche, have applied in the last few days for permission to market pertuzumab in the United States and Europe.

Approval could help the company recover from the recent decision of the Food and Drug Administration to revoke the approval of another Genentech drug, Avastin, for the treatment of breast cancer.

Avastin had been approved based on a trial that showed it delayed the worsening of tumors by 5.5 months — almost as big a gain as seen now with pertuzumab. But the use of Avastin did not prolong lives, and subsequent studies found a much smaller improvement in progression-free survival.

That could make the F.D.A reluctant to approve pertuzumab unless it also helps women live longer. But Dr. Sandra J. Horning, head of cancer clinical trials at Genentech, said the pertuzumab results on tumor progression were more trustworthy than the original Avastin results because the trial was conducted more carefully.

Novartis’s drug, everolimus, is a tablet that is already sold under the name Afinitor to treat kidney cancer and some rare tumors. Novartis plans to apply for the tablet’s approval as a breast cancer treatment by the end of the year.

Its clinical trial involved 724 postmenopausal women with hormone receptor-positive metastatic breast cancer.

The women who took both everolimus and a drug called exemestane had a median progression-free survival of 7.4 months compared with 3.2 months for those who took a placebo plus exemestane. Exemestane, also known by the brand name Aromasin, deprives tumors of estrogen, which can fuel their growth.

Women in the study already had failed to benefit from other estrogen-depriving drugs. So perhaps it is not surprising that the control arm did not do that well on exemestane alone.

“They put it up against a weak opponent,” said Dr. Peter Ravdin, a breast cancer specialist at the University of Texas Health Science Center at San Antonio, who was not involved in the study.

But trial investigators said the comparison was valid because in daily practice, doctors often use exemestane when other estrogen-blocking drugs fail.

Everolimus works by inhibiting mTOR, a protein that often spurs tumor growth after tumors become resistant to hormone therapy.

“This is the first time we have a strategy to revert endocrine resistance, which has been the holy grail of therapy for endocrine-positive tumors,” Dr. Baselga said.

Another drug — entinostat, from privately held Syndax Pharmaceuticals — might also be able to do that, according to the results of a small study presented in San Antonio. Women who received that drug plus exemestane had delayed tumor progression and also lived months longer than those who took exemestane alone.

Those results will have to be confirmed in a larger trial, and it will be several years before entinostat can reach the market.

Everolimus costs about $7,000 a month when used for kidney cancer. The drug can have significant, even fatal, side effects like mouth sores, infections and lung inflammation. That could give some doctors pause about adding it to hormone therapy.

“Hormone therapy, which is relatively well tolerated, becomes closer to chemotherapy” in terms of side effects, said Dr. Clifford A. Hudis, chief of the breast cancer medicine service at the Memorial Sloan-Kettering Cancer Center, who was not involved in the study.

Article source: http://feeds.nytimes.com/click.phdo?i=96fd2759ea7a0752691ad855a7bc5a14

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As U.N. Meets, a Battle Over Generic Biotech Drugs

September 19, 2011 by Leave a Comment

These generic drug companies say they are on the verge of selling cheaper copies of such huge sellers as Herceptin for breast cancer, Avastin for colon cancer, Rituxan for non-Hodgkin’s lymphoma and Enbrel for rheumatoid arthritis. Their entry into the market in the next year — made possible by hundreds of millions of dollars invested in biotechnology plants — could not only transform the care of patients in much of the world but also ignite a counterattack by major pharmaceutical companies and diplomats from richer countries.

Already, the Obama administration has been trying to stop an effort by poorer nations to strike a new international bargain that would allow them to get around patent rights and import cheaper Indian and Chinese knock-off drugs for cancer and other diseases, as they did to fight AIDS. The debate turns on whether diseases like cancer can be characterized as emergencies, or “epidemics.”

Rich nations and the pharmaceutical industry agreed 10 years ago to give up patent rights and the profits that come with them in the face of an AIDS pandemic that threatened to depopulate much of Africa, but they see deaths from cancer, diabetes and other noncommunicable diseases as less of an emergency and, in some cases, the inevitable consequence of better and longer living.

The debate has intensified in recent weeks, before world leaders gather at the United Nations on Monday and Tuesday to confront surging deaths from noncommunicable diseases, which cause two-thirds of all deaths. It is only the second global health issue that the United Nations General Assembly has deemed urgent enough to call a meeting to discuss.

Participants in the negotiations, which include nongovernmental organizations, described the Obama administration’s position on the issue and provided e-mails from European diplomats that laid out the American stance, which has been adopted in the agreement’s working draft.

Although the draft agreement for this week’s meeting at the United Nations offers no support for poor nations seeking freer patent rules to fight cancer and other noncommunicable diseases, their advocates have vowed to continue fighting to loosen those restrictions not only this week in New York but in continuing international trade negotiations around the world as well.

United States officials repeatedly declined to explain the American position, though Mark Toner, a State Department spokesman, said Friday, “Regardless of what you call it, this is clearly such a pressing challenge globally that world leaders are gathering in New York next week to discuss ways to confront this threat.”

The United States government has a long history of pushing for strong patent protections in international trade and other agreements to protect important domestic industries like pharmaceuticals and ensure continued incentives for further inventions.

The new biotech copycats are likely to stir sharp debate among advocates for the poor. Already, some contend that the billions spent to treat AIDS have crowded out cheap and simple solutions to other afflictions of poverty, like childhood diarrhea.

The copycats will be less expensive than the originals, but they will never be cheap. It is unlikely that many African nations will be able to afford such a costly medicine for breast cancer, when far cheaper ones for colon and testicular cancer are going wanting.

Dr. Yusuf K. Hamied, chairman of the Indian drug giant Cipla Ltd., electrified the global health community a decade ago when he said he could produce cocktails of AIDS medicines for $1 per day — a fraction of the price charged by branded pharmaceutical companies. That price has since fallen to 20 cents per day, and more than six million people in the developing world now receive treatment, up from little more than 2,000 in 2001.

Dr. Hamied said in a telephone interview last week that he and a Chinese partner, BioMab, had together invested $165 million to build plants in India and China to produce at least a dozen biotech medicines. Other Indian companies have also built such plants. Since these medicines are made with genetically engineered bacteria, they must be tested extensively in patients before sale.

Once those tests are complete, Dr. Hamied promised to sell the drugs at a third of their usual prices, which typically cost tens of thousands of dollars for a course of treatment.

“And once we recover our costs, our prices will fall further,” he said. “A lot further.”

Dr. Peter Piot, a former director of U.N.AIDS, the United Nations AIDS agency, said the parallels between the current dilemma over cancer drugs and the one 10 years ago over AIDS medicines were striking. “Without a major reduction in the prices of the essential oncology drugs, there’s no way we can really improve survival from cancer,” said Dr. Piot, currently the director of the London School of Hygiene and Tropical Medicine.

But he also said he was more cautious about the promise of generics this time, because biotech medicines were not easy to copy. “I believe these medicines will make a huge difference, but I would like to see the evidence that the quality is good before giving it to my patients or taking it myself,” he said.

Article source: http://www.nytimes.com/2011/09/19/health/policy/19drug.html?partner=rss&emc=rss

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Breast Cancer Patients Plead for Avastin Approval

June 29, 2011 by Leave a Comment

With desperate breast cancer patients imploring the Food and Drug Administration to change its mind, the agency’s staff calmly argued Tuesday that the drug Avastin should lose its approval as a treatment for that disease.

The pleas and presentations came on the first day of a two-day hearing at which Genentech, the manufacturer of Avastin, is getting a chance to try to persuade the F.D.A. to reverse its decision made in December to revoke the drug’s approval for advanced breast cancer.

The proceedings emphasized a conflict that has bedeviled pharmaceutical regulation and other efforts to control the practice of medicine — one between cold statistics from clinical trials about overall populations and the often emotional experiences of individual patients who say a therapy has, or might, work for them.

About a dozen women with breast cancer, some tearful, told the F.D.A. that while Avastin did not show a big benefit over all in clinical trials, the medicine did help some women substantially and should be left available for that reason.

“Despite the potential side effects from Avastin, metastatic breast cancer has only one — death,” Priscilla Howard, who said Avastin had controlled her cancer for 32 months, told the committee presiding over the hearing. “I want every available weapon in my arsenal as I fight this devastating disease.”

Avastin received so-called accelerated approval for metastatic breast cancer in 2008 under a system intended to allow drugs for serious diseases to get to market more rapidly, subject to later studies to confirm they really work.

The F.D.A. said that those subsequent studies had not confirmed that Avastin was safe and effective. With five randomized trials of Avastin now having been completed, the F.D.A. said, no trial had shown that Avastin prolonged life or improved the quality of life. And no trial showed that the drug delayed the progression of tumors to the same extent as the one trial that led to the drug’s approval.

“All we are asking for here is one trial that shows clinical benefit,” said Dr. Richard Pazdur, the head of the agency’s cancer drug division.

F.D.A. officials said that data from trials had not shown even a small subset of women receiving Avastin living substantially longer than those in the control group, raising doubts about whether there are “super responders” who derive great benefit from the drug.

“We’re just not seeing that population,” said Dr. Patricia Keegan, an official in the agency’s cancer drug division.

Even if the approval is revoked, Avastin would remain on the market as a treatment for other types of cancer, so doctors could use it off-label to treat breast cancer. However, insurers would be less likely to pay for the drug, which Genentech says costs a typical breast cancer patient $88,000 a year.

Women with breast cancer testifying at the hearing feared the drug would become out of reach for them and other cancer patients. Husbands, doctors and some patient advocates also spoke in favor. Each speech in favor of retaining Avastin’s approval was met by applause.

“Make no mistake, this hearing is a death trial, not of Avastin but of these women who rely on Avastin to stay alive,” said Terry Kalley, of Troy, Mich., whose wife, Arlene, is being treated with Avastin.

Mr. Kalley also helped organize a demonstration by women and their families that took place just outside the F.D.A. campus in Silver Spring, Md., where the hearing was held.

Representatives of advocacy groups for patients with ovarian, kidney and colon cancer and melanoma also spoke in favor of retaining the breast cancer approval, saying, among other things, that revocation could discourage drug development.

But defying the mood in the room, representatives of four breast cancer advocacy groups testified in favor of the F.D.A.’s proposal to withdraw the approval.

“What use is there for a drug which in this population has more toxicities, some very serious, than the previous standard of care?” said Helen Schiff of Share, a breast and ovarian cancer support group.

Ms. Schiff said that for every woman who testified Tuesday in favor of Avastin, there were others who were not helped by the drug or had even been hurt by side effects like brain hemorrhages.

“Those people don’t come to testify,” she said.

Christine Brunswick, representing the National Breast Cancer Coalition, said: “The F.D.A.’s decision on Avastin must be based on scientific evidence from well-done trials and cannot be based on any one individual story, no matter how compelling.”

These remarks were met by derision. “I am completely disgusted to have to follow somebody like that,” said Kim Jewett, a breast cancer patient and representative of mylifeline.org, a cancer support group, who spoke directly after Ms. Brunswick.

Genentech, which is owned by Roche, will present its case on Wednesday. Later that day, the advisory committee will vote on its recommendations for the F.D.A. commissioner, Dr. Margaret A. Hamburg, who will make the decision at some future time.

Article source: http://feeds.nytimes.com/click.phdo?i=306cd771a7de763415fa32d3c43d8b46

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Breast Device Recall Made Most Severe

April 14, 2011 by Leave a Comment

The recall of a medical device that left particles of the metal tungsten in women’s breasts has been classified as the most serious type of recall, one involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the Food and Drug Administration said on Wednesday.

The device, the Axxent FlexiShield Mini, was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles.

It is not known if tungsten is dangerous because relatively little research has been done on its long-term health effects in humans. But it shows up on mammograms and may make them difficult to read, an especially troubling effect for women who have already had breast cancer and worry about recurrences. The particles resemble calcium deposits, which can indicate cancer.

That the tungsten shows up on mammograms is what made the recall Class I, the most serious type, said Karen Riley, a spokeswoman for the F.D.A. She said the particles could interfere with diagnosis, because they can be mistaken for cancerous calcifications or may hide real calcifications. Twenty-nine women are known to have been affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and two at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. So far, 16 have had follow-up mammograms six months after their surgery, and all 16 were found to have tungsten particles.

Some of the women, concerned that the tungsten could be harmful, are considering having mastectomies to rid themselves of the particles. Seven are suing Hoag and the device manufacturer, according to Jeffrey Milman, a lawyer in Irvine, Calif., who is representing the women.

Mr. Milman said that for the purposes of the lawsuits, the F.D.A.’s decision to classify the recall as serious was “icing on the cake.” The device was made by a company called Xoft, which was subsequently bought by another company, iCad.

The Axxent FlexiShield Mini had been cleared by the drug agency in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans.

The shields were cut to fit each patient, and Ms. Riley said the tungsten particles were shed after the cutting. But why that occurred is not clear, because the shields were meant to be cut and were made with that in mind.

They were taken off the market in February. But at that time the drug agency was still studying the problem and had not yet decided what class the recall should be. It announced on Wednesday that it was class I, the most serious type. There are two lower recall classes, and lesser actions called market withdrawals and safety alerts.

Article source: http://feeds.nytimes.com/click.phdo?i=00e194f5d5894a53306973f27d48fee3

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Money Through the Ages: Pondering Risks in Retirement

March 26, 2011 by Leave a Comment

FRANCES AND JIM LANGERFELD know exactly how much they spent as newlyweds in August 1968. Rent for their house: $115. Groceries at Publix: $12.26.  A suit for Mr. Langerfeld: $62.68.  It is all meticulously detailed in an orange budgeting book that Mrs. Langerfeld pulled from her garage one recent evening. She kept several others, which offer a window into their family’s financial life.

The ledgers show that the Langerfelds bought only three new cars over the last four decades, including a big white Dodge van that they drove for 300,000 miles, mostly to ferry their four children to choir, hockey and soccer tournaments. Their biggest expense over the years, beyond their home here, was private school and college.

Now that the children are grown, the Langerfelds — he is 64, she is 62 — are contemplating retiring as soon as next year. While they have lived frugally, amassing about $720,000 in savings, they have the same reservations that vex many Americans on the cusp of retirement. Can we really afford it? Will our standard of living fall? How much will we ultimately get for the house?

Mr. Langerfeld, an engineer for a construction company, said he still enjoyed his job — and would not mind working a bit longer. For his wife, however, retirement cannot come soon enough. “I don’t want to die in my cubicle,” said Mrs. Langerfeld, who survived advanced breast cancer nearly seven years ago.

But the Langerfelds said they might have an ideal solution: buying a 10-room motel on an idyllic island, just off Maine in New Brunswick, Canada, where they already own half of a vacation home with friends who want to sell their share. The motel, popular among bird watchers, typically generates about $25,000 in income a year after expenses.

Mr. Langerfeld, a master repairman, would keep busy maintaining the motel, while Mrs. Langerfeld, a fastidious record keeper, would handle the books.

“We figured it was a good investment and would give us something to do,” she said.

They discussed their situation with Kathleen Rehl, a financial planner and author in Land O’Lakes, Fla., who, as a 64-year-old widow, is thinking about phasing into retirement herself. She calculated their net worth at $1.2 million. Their only debts are $20,000 in education loans for a son and a $10,000 401(k) loan.

“Right now, they are standing at the abyss, and they have lots of risk in their life,” said Ms. Rehl, who said she had major reservations about the motel.

The Langerfelds do not know how much their house will fetch, but the motel would lock up at least $200,000. Then there is the business risk, though the couple has met with the motel owners and studied their finances. They must also run the motel for two years before they can apply for permanent resident status, which an immigration lawyer said they were likely, but not guaranteed, to get. And it could be tough to sell the motel if they needed to.

Though healthy now, the Langerfelds have had three cancers, heart bypass surgery and a minor stroke between them. Mr. Langerfeld would qualify for Medicare by the time they got there, and could easily go to Maine for treatment. But Mrs. Langerfeld would have to buy health insurance for the three months they said it would take them to get Canadian health care.

Ms. Rehl raised other questions: Can either of them run the motel alone? What is their exit strategy? The Langerfelds said the current owners ran the motel five months a year.

“Jumping into the motel business would be challenging,” Ms. Rehl said. Ideally, she would want Mr. Langerfeld to wait until full retirement age to collect Social Security, which would yield a bigger check, for him and for his wife, should she live longer.

Ms. Rehl suggested selling the Tampa house first, then renting for two years while they still worked. Mrs. Langerfeld did not dismiss that idea. Still, she expressed a sense of urgency if they were going to proceed with the motel. They said they were more likely to gain permanent residence status in Canada sooner than later. “We’re lucky to have the years that we have, after all the health scares,” she added. “I want to do something else.”

Here is what their income picture would look like: if they clear at least $400,000 from their Tampa home — it is worth $502,000, according to Zillow, the real estate Web site — and use the proceeds to buy the motel and their friends’ share of the home, their $720,000 would remain intact.

So Ms. Rehl estimated the Langerfelds would have $67,000 in income — $38,000 from Social Security and nearly $29,000 from savings, assuming a 4 percent withdrawal rate. Since the bulk of their retirement money is in traditional Individual Retirement Accounts and 401(k)s, she said they would owe about $2,000 in federal taxes on that income. But she suggested they speak with an expert in cross-border tax issues.

The motel income would be extra, and the Langerfelds said their cost of living in Canada would be much lower. Ms. Rehl said they spent $100,000 in 2009, excluding their savings, but the Langerfelds said it was an unusually expensive year because of their two sons’ weddings and Mrs. Langerfeld’s mother’s funeral. Ms. Rehl said if they downsized in Florida, they would have more money from which to draw. But the Langerfelds said their cost of living would be higher.

Then there is their portfolio, where stocks, precious metals and mining investments account for 72 percent of their money — far too risky for their age. “I had to take the risk because we didn’t have enough money to retire,” said Mrs. Langerfeld, who handles the investments. “It has been a successful ploy.”

But she knows her luck could turn quickly, and is ready to shift into something safer. In fact, she was not certain she wanted to put as much as 40 percent into stock index funds, which Ms. Rehl had suggested, since she predicts the market is headed for a fall.

For now, the Langerfelds are honest about the myriad risks of the motel and continue to do research. Mr. Langerfeld said it would ultimately be an emotional decision. “There are so many factors beyond our control,” he said, “that there is really no way to make a logical decision.”


Article source: http://feeds.nytimes.com/click.phdo?i=df932af8026197fd2132aa0b4abf4538

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