Chemotalk Newsletter

Chemotalk Newsletter, Vol. 47: March 1, 2012

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March, finally! Everything is blooming, or getting ready to. On that happy note ...


(Reuters) - Health regulators granted a priority review for an experimental BREAST CANCER drug that in clinical trials added six months to the time before the disease worsened.

The Food and Drug Administration will make its decision on whether to approve pertuzumab by June 8.

With priority review status, the FDA decides whether to approve a drug within six months, rather than the usual 10- to 12-month review period. The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.

In a pivotal clinical trial, patients who received pertuzumab in combination with Herceptin -- another breast cancer drug -- and a CHEMOTHERAPY agent lived for an average of 18.5 months without their tumors growing. That compared with 12.4 months for those who got only Herceptin and the chemo drug. Overall survival data from that trial is not expected to be available until 2013, but the FDA apparently found the available progression-free survival data compelling enough to makes its decision prior to that.

Pertuzumab, a biotechnology drug, is being considered for patients with advanced HER2-positive breast cancer who have not received prior treatment or who have suffered a relapse following surgery.

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And not-so-great news for prostate patients:


Amgen Inc., the world¹s biggest biotechnology company, failed to win the backing of a U.S. advisory panel for its drug to delay tumors spreading to bones in patients with advanced PROSTATE CANCER. The panel voted 12-1 that the risks outweighed the benefits of the drug, Xgeva. Food and Drug Administration staff questioned in a report whether the ability to delay tumor growth in bones is enough to justify approval. The drug, known chemically as denosumab, didn¹t extend lives in a study.

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The following piece in Forbes Magazine by staff writer Matthew Herper hits the Komen nail on the head:


Here¹s what really gets me about Susan G. Komen¹s PR fiasco: the BREAST CANCER charity managed to shoot itself in the foot just as it was starting to really make a scientific difference.

Now its best hope for fixing its tattered reputation is simple: live up to that relatively new name, Susan G. Komen for the Cure, which it adopted in 2007. Develop some drugs that slow breast cancer.

For much of its history, Komen was more ³for the screen² than ³for the cure,² believing that the expansion of mammograms and breast exams would allow cancer to be detected early and vanquished often. No wonder many cancer survivors feel so betrayed by Komen¹s decision to stop funding preventative screening at Planned Parenthood ­ it was undermining one of Komen¹s biggest accomplishments. But while screening in women over 50 does prevent women from dying, decreasing mortality by perhaps 15% according to studies, screening with current technology won¹t stop tumors soon enough.

Komen has tossed tons of money into research since it was founded, but it puts twice as much into public health education as into research. And I can¹t think of a single drug or treatment that would not exist were it not for Komen¹s largesse. (An email requesting comment on this was not returned.)

Meanwhile a new generation of smaller, more focused disease charities has been getting drugs invented. The most dramatic example is the Cystic Fibrosis Foundation, which in the mid-1990s started funding drug research directly at companies. The biggest result is Kalydeco, a drug from Vertex Pharmaceuticals, that actually reverses that deadly lung disease for the lucky few who have a particular genetic mutation ­ albeit at a $250,000-per-person cost. But there¹s been a string of breakthroughs from the CFF, including aerosolized saltwater to clear mucus from lungs and new antibiotics.

The Multiple Myeloma Research Foundation sped research on Velcade, the Takeda MYELOMA drug that was taken by Geraldine Ferraro. The Leukemia and Lymphoma society helped support the early research on the LEUKEMIA drug Gleevec before maker Novartis started to realize the drug¹s potential. The key, aside from interacting with companies, is to create a network of top experts who guide research and help conduct clinical trials.

Komen has been very late to this new approach, but it did finally come around five years ago when it appointed Eric Winer, of the Dana Farber Cancer Institute, to guide its research organization.

I called up George Sledge of Indiana University, who serves with Winer on Komen¹s scientific advisory board and who is also the past-president of the American Society of Clinical Oncology. He didn¹t contest my contention that over the long term, Komen¹s impact has not been as big as it might have been. But he did argue that things are changing as the organization¹s research focus turns to high-impact work.

³In the past Komen did broad funding for anything that had the word breast cancer,² Sledge says. Now, they want ³research that will have an impact on morbidity and mortality within a defined period of time.²

One recent example: a study of how particular genetic variants may predict which women have nerve toxicity as a result of CHEMOTHERAPY. Another: work by Fredika Robertson of M.D. Anderson Cancer center showing that some forms of inflammatory breast cancer, a particularly deadly kind, are caused by mutations that boost levels of anaplastic lymphoma kinase, or ALK. Which sounds like Greek until you realize that Pfizer just got a drug for ALK positive LUNG CANCERS approved; the work, funded by Komen, opens up the possibility that the medicine, Xalkori, might eventually play a role in fighting breast cancer.

³If you¹re not excited by cancer research now you¹re soulless,² Sledge says. ³It would be a tragic time to lose any funding.²

Screening women over 50 to try to find breast cancer tumors early reduces mortality from the disease by 15% or more, but that still leaves a lot of women to die. As women¹s health advocate Susan Love noted in the New York Times, we¹re in dire need of a better understanding of what causes breast cancer so we can detect it earlier and treat it more effectively.

But whereas Love¹s essay pushes for more prevention, I¹d argue Komen should use its money to take the opposite approach. Get drugs to market for patients in the late stages of breast cancer, because this is where the marketing of cancer drugs begins. Find experimental medicines in testing, in industry and out, and fund them. Keep drug companies from cutting staff on programs by offering to help pay for the research, no strings attached. Make a renewed commitment to living up to its name, and promise results. One place to start would be in triple negative breast cancer, a deadly form of the disease where medicines are having trouble being effective. Fund clinical trials of medicines that work in other cancers. Act like breast cancer is a rare disease, and be the organization that gets medicines to market.

Lots of the people angered by the Komen Foundation¹s move want to abandon it for other charities. But the fact it that the pink-on-everything marketing machine is powerful. Want to be trademark ³Race For the Cure?² Run faster.

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Finally, something I can post about rheumatoid arthritis:


Researchers at Tampere University of Technology (TUT), Finland, have developed what they believe to be the first biodegradable joint implant. The implant, called RegJoint, is used in the treatment of osteoarthritis and RHEUMATOID ARTHRITIS.

The RegJoint is fabricated from biodegradable polylactide copolymer and is placed inside the capsule that surrounds the joint. It is designed to stimulate growth of connective tissue and soft tissue around the joint in order to replace cartilage lost to rheumatoid arthritis and osteoarthritis.

From the press release:

Rheumatoid arthritis and osteoarthritis destroy the normally smooth cartilage that lines the ends of bones. As cartilage regenerates poorly, the injuries are difficult to treat. Joint injury reduces mobility and causes pain. The conventional surgical options involve permanent implants or the artificial induction of joint ossification between two bones. RegJoint offers an alternative for conventional surgery and has several advantages over permanent implants. For example, the patient¹s own bone tissue remains intact during the operation. In addition, the implant makes the reconstruction of the joint more sustainable and cushions the area, relieving pain caused by friction between the bones.

To date the RegJoint implant has received CE approval and has undergone successful clinical trials both in Finland and abroad.

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Sarasota Memorial Hospital, in Sarasota, FL, is the first site in the world to enroll participants in a study using newly diagnosed OVARIAN CANCER patients¹ immune systems to create a personalized drug designed to target and destroy their deadly disease.

Should the custom-blended medicine, called CVac, succeed in keeping the cancer from returning, it could extend the lives of more than 22,000 U.S. women whose cancer is diagnosed each year. There is even a chance that CVac ‹ called a vaccine because of its potential to immunize the patient ‹ could be made powerful enough to prevent ovarian cancer in the first place.

The experimental vaccine, developed by Primo BioMed in Australia, has passed safety studies and won approval for marketing in the Middle East. Other clinical trials have involved women with advanced ovarian cancer, but this is the first study of effectiveness in newly diagnosed patients.

The enthusiasm of one local women¹s cancer specialist thrust Southwest Florida into the global picture in ovarian cancer research. This is the kind of advanced-stage study once confined to major academic centers. But new technologies are enabling people in places like Sarasota to participate in cutting-edge research without leaving home. Three local women have already been accepted in the study, said James Fiorica, the principal investigator in the research who pushed for trial here.

Ovarian cancer most often strikes women over 55, and has a high fatality rate because its symptoms are usually so subtle ‹ bloating and abdominal discomfort ‹ that the cancer spreads to other parts of the body before detection. CVac is designed for the 80 percent of ovarian cancer patients whose tumors contain an antigen called mucin-1, which the vaccine was developed to seek out and kill.

There is no guarantee the vaccine will work, and 50 percent of patients in the study will be getting a placebo instead of the real thing. But vaccines will be created for all participants, Fiorica said. If during the trial it becomes clear that the vaccine is working, those who have been given placebos would receive it as well. And those who are chosen for the CVac trial will have little to lose, since there are no other preventive treatments currently available.

Surgery is the current standard treatment for ovarian cancer, followed by CHEMOTHERAPY, Fiorica said. After that, there is little a doctor can do but observe the patient, hoping tumors will not reappear. CVac has the potential to prevent a relapse.

Ovarian cancer is ³so difficult to find in the first place. If there¹s a way you can prevent it, that¹s what you want to do,² Fiorica said. The chance that CVac can accomplish this without harmful side effects ‹ because it harnesses the patient¹s own immune system ‹ motivated him to organize a local trial. Sarasota was the first site to have participants accepted, and the goal is to enroll 1,000 patients on several continents.

³This was such a novel approach that I was quite proactive,² Fiorica said. ³We had to make sure we had all the labs and systems in place, and we sent samples around the world. This community¹s been wonderful; it takes a lot of resources to control all this.²

Jonathan S. Berek of the Stanford Cancer Institute, a member of the Ovarian Cancer Research Fund¹s scientific advisory committee, is the principal investigator on a related trial of CVac. He said the drug ³could be incorporated as a primary treatment² for ovarian cancer someday ‹ ahead of surgery or chemotherapy. He said a similar vaccine has been shown to work well in men with relapsed prostate cancer.

³You¹re using the body¹s own white blood cells to target the tumor,² he explained. ³You¹re trying to take a white blood cell, and program it to identify the cancer cell as something bad and foreign and try to kill it. The science behind it is good and sound, but the trial is designed to test that hypothesis,² Berek added. ³The ultimate dream is that we would find other ways to prevent this cancer than removal of the ovaries.²

Once a patient is accepted in the study, her plasma will be drawn by technicians at the blood bank, who will separate her dendritic cells ‹ a type of white blood cell ³believed to be the commander of the immune system,² Fiorica said. Those cells will be ³supercharged² and used to make a vaccine just for her. This procedure takes place after surgery, but before chemotherapy takes its toll on her white blood cell count. When chemo is complete, the patient will be vaccinated six times over several months. ³One of the positive sides of going on a trial is that there are a lot of eyes looking out for you and your cancer,² Fiorica said.

Fiorica said the teamwork among local health care providers shows the same commitment to research that inspired Jackson Laboratory¹s quest to establish a personalized medicine institute here. It has attracted collaborators from the University of South Florida College of Medicine to include Sarasota Memorial in studies. It was responsible for landing the CVac trial.

Fiorica said he appreciates the chance to spare his patients the disruption of traveling to major research universities to take advantage of the latest science. ³The patients stay here, and their tissues are sent all around the world,² he said. ³If you can accomplish that, that¹s the way it should be.²

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Zach Nielson at age 11 couldn't quite put his finger on the two words his doctors were avoiding using around him. But his mother certainly could. Deb Nielson knew people in wheelchairs, knew what it meant that Zach was waking up numb, knew how scary it was when he staggered stiffly down the hallway like a young drunk.

But just over two years later, a new generation of powerful drugs has drained the power of the words "MULTIPLE SCLEROSIS" for Zach and thousands of patients like him. The drugs have erased symptoms and reversed nerve scarring in the largest subgroup of MS sufferers, transforming for the first time victims' experience with the disease.

Far from a life sentenced to relentless disability, Zach Nielson is among a growing group who feel as if their MS never happened. "When they first told me, I was worried it would get worse and worse, and I wouldn't be able to have my dream job," said Zach, who just turned 14. "Now I know I can be a pilot."

The new class of drugs "gave me my active son back," Deb Nielson said. "I'm convinced of that now."

`Eight hundred MS patients are on Zach's miracle drug, Tysabri, through the Rocky Mountain MS Center and the University of Colorado Denver's Anschutz Medical Campus. Hundreds more are on Gilenya, the first approved oral treatment for MS, and other new drugs introduced in recent years.

Dr. Tim Vollmer, an MS expert, calls it a "rich tool set of many drugs" and said it's "not unusual for those patients to come in and say, 'I don't feel like I have MS anymore.'"

"People with MS have a reason to be optimistic," said Dr. Timothy Coetzee, chief researcher at the National Multiple Sclerosis Society in New York.

Elissa Berlinger, 25, now feels the kind of hope as she leaves Colorado for graduate school that she only recently thought might be impossible. The MS education for Berlinger began five years ago, when she was 20 and energetic and about to leave on a dream student-travel trip to Europe. She got strep throat and mono just before she left, then felt weakness in her hips. While traveling, she collapsed on the way to a hotel bathroom.

Her descent into the mystery of the disease followed classic lines: flare-ups every few months, numbness from hip to toe, amateur diagnosis of a slipped disc or lingering mono. X-rays for a tumor were negative, and the next step was an MRI. "I always said the unknown is scarier than anything else," Berlinger said.

Before she got the MRI results, a colleague with MS tried to prepare her for bad news with supportive advice. Berlinger turned 24, got an MS diagnosis the next day and promptly returned to Europe and the land of denial. Eventually, her stateside doctors gave her a book on "the big four drugs" at the time and told her to go home and decide which one to try. They all sounded terrible ‹ painful shots with uncertain results."The choices were which is the lesser of the evils," said Berlinger.

The older set of MS-fighting drugs was interferon-based, with many possible side effects. They stopped relapses only about a third of the time for patients in the most common category, relapsing-remitting MS.

Berlinger, aided by parents more aggressive than her in researching the illness, chose to go on a clinical trial of a newer treatment. CU Anschutz, a national leader in MS research, has 30 clinical trials at a given time on measures to attack the disease.

But Berlinger's trial didn't work out; she had three relapses in 12 months, and her lesions were still growing.

In the meantime, the Food and Drug Administration had begun approving the new generation of measures that targeted MS at the molecular level, rather than the cruder blocking of immune-system problems. Gilenya, the first oral drug, was effective more than half the time. Tysabri was a bigger breakthrough, using IV treatment and stopping relapses 70 percent of the time while removing lingering traces of symptoms. The new agents are powerful and dangerous, though, and the FDA briefly yanked Tysabri from the market when some patients with a common background virus developed brain infections. In a rare move, the FDA allowed Tysabri back on the market with strict protocols. Patients are tested for the virus, must come in for the IV treatment every four weeks and must check in with their neurologist every three months.

Berlinger went on Tysabri in January 2011. She has had no flare-ups of symptoms since then. An MRI in December showed there had been no new progression of the lesions.

"Tysabri is a paradigm-changer," Vollmer said. "We're no longer just trying to slow the disease. Now we're reversing it."

"I no longer worry about waking up numb," Berlinger said. She's leaving soon for grad school at Smith College in Massachusetts. Success with the new drugs has dimmed the power of long-held assumptions about MS.

What the researchers want to do now is start combining the new class of drugs to see whether layering the chemicals can solve ongoing MS mysteries. The new drugs are still considered treatments, not cures. In some patients, symptoms linger even when their worst relapses are blocked.

And then there are the causes of MS, which despite all the advances are still the core puzzle of the disease. The nerve-sheath damage may affect more than 400,000 people in the U.S., yet why it starts in those patients remains the thin section of medical manuals.

Scientists believe MS begins somewhere in a combination of genetic vulnerability, infections and environmental triggers. Vitamin D deficiency is one factor, explaining why Colorado, Minnesota and other states far from the equator's full sunshine report more cases. Researchers at Anschutz have likened studying MS in Colorado to studying malaria in Africa.

Without the precise triggers established in MS, the ultimate goal of a vaccine proves daunting. Yet researchers are avidly pursuing one. Anschutz has launched a Translational Research Laboratory at the Rocky Mountain MS Center to push basic petri-dish findings into clinics.

Vollmer is interested in a type of regulatory cell that is lacking in MS patients. He would like to grow a replacement cell that blocks reactivation or flare-up of the MS. If that worked, it might lead to a vaccine for family members of MS patients ‹ they are up to 50 times more likely than other families to also contract MS, and those cells could block the disease from taking hold in them.

None of the science comes cheap. Tysabri and other new drugs can cost $50,000 a year for each patient. Insurance companies may pay if other treatments have failed, but patients can be overwhelmed negotiating that labyrinth.

"We're very fortunate. I have very good insurance," Deb Nielson said. Still, Nielson had to make extra effort because Zach's Tysabri had not yet been approved for children. She feels relief every time she looks at Zach's face. Or through the distorted lens of his past sixth-grade graduation photo in which he was puffed up by cruder steroid treatments.

Zach's main preoccupation with MS these days is how to turn his personal knowledge into a good Eagle Scout project.

"It feels manageable now," he said.

About multiple sclerosis (a comprehensive description)

Multiple sclerosis occurs when the body's immune system attacks the fatty sheath protecting the central nervous system. The sheath, called myelin, forms scars, or "lesions," and the scars block and jumble the signals meant to travel smoothly along the nerves.

The inflammation results in numbness, paralysis of differing severity, sight damage and other symptoms. Most MS patients have a form called relapsing-remitting, with sudden flare-ups followed by periods of recovery. Others have a progressive form that so far is less treatable by the new generation of drugs.

Why MS happens in up to 1 in 580 Coloradans is far less clear. Scientists suspect a combination of genetic propensity, viral triggers and environmental factors. They know many MS sufferers have vitamin-D deficiency in common, possibly explaining why higher latitudes with less sun exposure see more cases.

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A lot of information about breast cancer this month, but this story, in particular, highlights an extremely important issue: breast density. The fact is, mammograms don't work well for women with dense breasts:


In an effort to detect hidden breast cancers, Virginia is poised to become the third state to require radiologists to notify women if they have dense breast tissue.

This month, the General Assembly without opposition passed legislation requiring radiologists to put information about breast density in the federally mandated post-mammogram letters already sent to patients. Gov. Bob McDonnell will sign it, a spokeswoman said, calling it a "common-sense measure to ensure women's health."

Dense breast tissue makes it harder to detect cancer with a mammogram. But there is debate over whether women with dense tissue are at increased risk for BREAST CANCER. Some medical experts caution that the wave of breast density laws being proposed throughout the country may be premature and harmful, and could result in unnecessary - and expensive - tests.

The concern: What women will do with the knowledge that they have dense breasts.

"What we don't know is whether telling them that information gives them anything to act upon," said Dr. Barbara Monsees, chairwoman of the American College of Radiology Breast Imaging Commission. "Does it change what they can do or what they should do?"

Current scientific research doesn't answer those questions. Monsees said the laws could undermine the confidence that women have in mammography if they are told the test may not detect cancer. "That would be a shame because we know mammography saves lives," she said.

For those who have fought for the legislation in Virginia and elsewhere, the reasoning is simple: Women have the right to be informed about their health. "I came at it from the perspective as well, trying to get patients to be their own best advocate," said Del. Bobby Orrock, R-Caroline County, who sponsored the bill in the House.

Connecticut and Texas have passed similar laws, and 13 other states are considering legislation. A federal bill was introduced in the House last year.

Roanoke resident Joan Vannorsdall, 60, first learned she had dense breast tissue in August when she was diagnosed with breast cancer. After requesting a decade's worth of mammogram results from her medical file, Vannorsdall learned that radiologists had been noting her dense breast tissue as far back as 2003.

"That was really the stunner to me," she said. "It made me think, maybe mammography wasn't the magic silver bullet." After all, every mammogram she had, including the one in August, came back negative.

Vannorsdall's cancer was detected not by the annual screening, but by her gynecologist, who thought she felt something during a physical exam. It wasn't until an ultrasound was done that anything suspicious was found. A biopsy later revealed the cancer.

Vannorsdall began to research breast density and soon came across a Connecticut-based advocacy group, Are You Dense, which has led a campaign to educate women about breast density. The group is engaged in the legislative efforts throughout the country and played a role in the Virginia bill.

Vannorsdall testified before the Senate Education and Health Committee in January. "It is a matter of life and death to women," she said. "And this will save lives."

Not everyone agrees. "The real question is, 'Will we save lives? Will we improve the treatment?' " said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. "We don't have an answer. There has been no systematic study that has been done."

About half of women who have a mammogram have some degree of breast density, according to the American Cancer Society.

"I certainly agree that women need to understand both the benefits, risks and limitations of screening mammograms," Lichtenfeld said. "That is important. Quite honestly... we have not done a very good job of doing that." The society hasn't taken a position on breast density legislation, he said.

The Virginia legislation does two things. First, it requires a radiologist to report breast density to the physician who ordered the mammogram. Second, if that report indicates that a woman does have dense breast tissue, then the patient must be informed in her post-mammogram letter.

As approved by the General Assembly, that letter will read: "Your mammogram demonstrates that you may have dense breast tissue, which can hide cancer or other abnormalities. A report of your mammography results, which contains information about your breast density, has been sent to your referring physician's office, and you should contact your physician if you have any questions or concerns about this report."

The medical community supports the requirement that radiologists report breast density to physicians, and Monsees said that has been part of the American College of Radiology's recommendations for years.

It is the wording of the letter to patients that caused a behind-the-scenes debate about the Virginia legislation. The Medical Society of Virginia and the Virginia chapter of the American College of Radiology argued against the original wording, which would have suggested that additional screening tests might be warranted.

"If you indicate to a patient that there are other diagnostic tests that are better, it is misleading," said Ann Hughes, the lead lobbyist for the Medical Society of Virginia.

Other imaging tests, such as MRIs and ultrasounds, are used to detect some breast tumors in women at high risk for breast cancer, but they are imperfect, medical experts say. They are expensive and generally not covered by insurance for routine screening. The concern is that if more women start having screening ultrasounds or MRIs, more biopsies of suspected tumors might be performed. But more biopsies also might come back negative, and the additional testing may not result in fewer deaths.

Vannorsdall said any opportunity to detect breast cancer and save a life should justify the tests. While she said she is disappointed that the wording of the letter was "watered down," she is happy the legislation will prompt the discussion between a woman and her doctor.

It's that conversation that the two men who sponsored Virginia's legislation said they wanted to encourage. "Hopefully, it will save lives and provide women with the education they need about their particular situation," said Sen. John Edwards, D-Roanoke.

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I'm ending this newsletter with a shout-out. If one young lady who was angered by BofA's attempt to charge $5 to anyone accessing their own money, maybe it's time for us to start a similar petition, to prevent someone from losing their life because the drugs that might help them are unavailable. If anyone out there feels so inclined, please contact me. I'd be willing to work on this:

From The New York Times editorial page:


Bills to solve the problem are languishing in Congress

A severe shortage of a drug used to treat childhood LEUKEMIA appears to be easing, lessening the risk that hundreds if not thousands of children might die from a curable disease. This close call and continuing shortages of other vital drugs again highlight why Congress might pass legislation giving the Food and Drug Administration more power to head off such crises.

Some 180 medically important drugs -- most of which are injected in hospital, clinics and doctors' offices -- have been in short supply over the past year. This latest shortage involved a drug known as preservative-free methotrexate, which is injected into the spinal fluid to treat ACUTE LYMPHOBLASTIC LEUKEMIA in young children. The preservative can cause paralysis and thus cannot safely be used.

Like many other such shortages, this one was caused by manufacturing problems at one of the few plants still making the drug. One of the nation's largest suppliers of methotrexate suspended operations at a plant in Ohio in November because of production and quality concerns. Supplies of the drug subsequently dwindled to the point that major hospitals were close to running out.

The shortage should ease in a couple of weeks because the manufacturer, Ben Venue Laboratories, will release supplies made before its plant shut down and three other manufacturers have agreed to increase their production at the request of the F.D.A.

Under an executive order issued by President Obama in November, the F.D.A. has been trying to head off shortages by asking manufacturers to report well in advance about any problems that might disrupt their production as that steps can be taken to find alternatives. That is a start but not enough.

Bills pending in both chambers of Congress would require, not just ask, manufacturers to provide six months' advance notice of planned interruptions and prompt notification of unplanned disruptions The bills would also expand the range of manufacturers who have to provide notification, and would punish failures to notify with civil fines that could reach $1.8 million under the House version.


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See you next month ...

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And if you have any thoughts of how this newsletter could be improved, please email me directly, at

Elaine Jesmer

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