The Influence Game: Peanut Industry Wants Help Too
In a nutshell, thats the theme of a lobbying and public relations campaign to help the industry rebound from a salmonella crisis blamed for killing at least nine people and sickening nearly 700 others.
With more than 3,400 peanut products recalled in the outbreak linked to Peanut Corp. of America, a rattled public is buying less of them. One analyst puts the economic damage at $1 billion.
The effort by farmers and food manufacturers is part of a delicate strategy: Backing new federal food safety rules to help reassure consumers, while opposing steps they think go too far. It also illustrates a hard lesson learned by groups that find themselves in Congress crosshairs: It is better to help lawmakers shape regulations than to let others do it for you.
“We know things are going to have to be done, and we want to be part of fixing the problem,” said Mike McLeod, a lobbyist representing the Western Peanut Growers Association, whose members are Texas peanut farmers. “We want to be perceived as being constructive in trying to get this problem behind us.”
The nations 10,000 peanut growers get nearly $1 billion a year for their crops, with products like peanut butter and candy generating billions more, according to Stanley Fletcher, a University of Georgia agriculture professor specializing in peanuts.
Fletcher estimates farmers alone could lose $500 million this year from the salmonella crisis, with an additional $500 million lost in overall economic activity. That makes tougher safety standards an easier sell to an industry which might otherwise resist.
“A safer product means higher consumer confidence. Higher consumer confidence means they sell more product,” said Rep. Sanford Bishop, D-Ga., whose state is the nations largest peanut producer.
Farmers have come to Washington to lobby Congress and the Obama administration. Theyve asked them to buy more peanut butter for federal feeding programs and to change a government program they say is driving peanut prices down. But the main focus is on safety.
The most prominent food safety bill is one sponsored by Senate Majority Whip Richard Durbin, D-Ill., backed by Republican Sens. Saxby Chambliss and Johnny Isakson of Georgia. It would require companies to have food safety plans, empower the Food and Drug Administration to recall tainted products and require annual FDA inspections of facilities it considers high risk.
Durbins bill has drawn praise from farmers, food manufacturers and consumer advocates, though there are divisions over whether to seek even stricter legislation. Consumer groups prefer at least yearly inspections for all food facilities, fees on food manufacturers to pay for the inspections and electronic tracking of food shipments.
“If they really want to protect their industry, they should support tougher oversight,” said Jean Halloran, director of food policy initiatives for Consumers Union.
The views of peanut interests are not uniform. Some farmers back requirements – like annual inspections of all food manufacturers, not just the risky ones – that the manufacturers oppose.
Tougher rules are needed but some, like yearly inspections, would make little sense, argues the Grocery Manufacturers Association, which represents major food companies.
“We should focus on activities that truly increase the safety of food and minimize steps that ultimately may increase the cost of food,” said association lobbyist Scott Faber.
The food manufacturers far outgun peanut farmers in the lobbying wars.
The grocery manufacturers alone reported spending $4.5 million on lobbying last year, according to the nonpartisan Center for Responsive Politics, and recently hired the high-profile Duberstein Group to lobby on food safety issues. The Texas growers reported spending just $40,000 lobbying last year, while the Georgia Peanut Commission, representing that states farmers, spent $100,000.
Convinced legislation alone isnt a solution, peanut interests have launched public relations campaigns.
Army Officials Say War Concussions Overdiagnosed
The three are taking aim at Department of Veterans Affairs rule for treating such veterans and determining disability pay. They want to call many mild cases “concussions” rather than “brain injuries.” They say the latter implies an ongoing, incompletely healed problem rather than a temporary one thats in the past.
“I think its fair to say theres overdiagnosis of concussions going on,” said Dr. Charles Hoge, a top Army psychiatrist. Hes one of three authors of an article published in Thursdays New England Journal of Medicine.
Some veterans groups applaud efforts to better diagnose traumatic brain injuries, but say its more likely that the military has been undertreating the problem.
“It stretches credulity to believe that all the people who have suffered traumatic brain injuries in Iraq and Afghanistan are getting the treatment they need. Thats a laughable notion,” said Jason Forrester, director of policy at Veterans for America, an advocacy group.
The military defines a concussion – or mild traumatic brain injury – as a blow or jolt to the head that caused loss of consciousness, altered consciousness or amnesia. Most are due to pressure waves from being near bomb blasts.
More than 300,000 U.S. veterans of the wars in Afghanistan and Iraq have suffered head injuries, many of them concussions that have gone untreated, according to a Rand Corp. study released last year.
Part of that estimate stems from a questionnaire given to service members as they finish their deployment, which may be months after a blow or jolt occurred, Hoge and his colleagues wrote. Service members cant always get a thorough medical assessment on the battlefield.
According to the authors, heres the problem: The questionnaire asks whether the person became dazed or confused at the time of an injury or blast, and it attributes such symptoms to concussion.
But a soldier can become dazed from stress, lack of sleep, the confusion of war, or other causes, they argue. In fact, Hoge published a study last year in the New England journal showing that many brain injury symptoms were actually due to post-traumatic stress syndrome, or PTSD.
The Rand study said some troops may incorrectly blame their problems on head injuries.
Trained doctors should be able to sort out the cause of symptoms. But Hoge and his colleagues argue that a concussion diagnosis can still occur, because of subjectivity and the fuzzy concussion definition.
“The problem is were attempting to measure concussion many months after injury,” said Hoge, director of psychiatry and neuroscience at the Walter Reed Army Institute of Research in Silver Spring, Md. He wrote the article with Herb Goldberg, a communications specialist at Walter Reed, and Carl Castro, a psychologist at the U.S. Army Medical Research and Materiel Command at Fort Detrick, Md.
“Its a very, very, very mild physical injury” that often doesnt need medical treatment, Castro said.
The VA last year created a disability category for residual effects of traumatic brain injury that was based on subjective, poorly defined symptoms, Castro and his colleagues argued. More scientific diagnosis criteria are needed “to ensure that disability regulations do not generate disability,” the authors wrote.
Treatment of mild traumatic brain injuries can cost up to $32,000 per case, the Rand report said. But if the diagnosis is wrong, patients are exposed to drug side effects and other risks, according to Hoge.
VA officials issued a statement this week saying they are proud of their efforts to treat traumatic brain injuries. Forrester, the veterans advocate, said estimates of concussions are probably low because some service members fear that being diagnosed with a neurological or psychological problem would hamper a military career.
Better assessment is needed for a complicated problems, he added. “These are the most difficult, thorny wounds of war,” he said.
White House Seeks Health Policy Compromise
Offering the option of government coverage to workers and their families has become one of the most contentious issues in the debate about overhauling health care to cover the uninsured and curb costs. Obama has proposed a public plan, and liberals insist it be part of any final deal. Conservatives and businesses fear that could open the door for a government takeover of the system.
Nancy-Ann DeParle, director of the White House health reform office, said a public plan could be designed to address concerns about the federal government overreaching in its role.
“Im actually very hopeful that well be able to reach an agreement on that, because it is part of the presidents plan,” DeParle said in a session with reporters at which she fielded repeated questions on the issue. “Its included because he wanted a mechanism to lower costs and to keep the private sector honest.”
But the insurance industry remains skeptical, and many Republicans say any kind of public plan would be a deal breaker.
DeParle suggested one compromise might be that the public plan pays hospitals and doctors rates similar to what private insurers pay. That would address fears that government would use its muscle to pay rock-bottom prices for medical services, allowing the public plan to charge discounted premiums that private insurers couldnt compete with.
Even if the government plan paid private-market rates to doctors and hospitals, it could still cut costs, DeParle said. A government plan wouldnt have to turn a profit, and could also save on administrative expenses.
“If its a policy disagreement, there are ways of bridging that gap,” said DeParle.
However, DeParle acknowledged that ideological objections to governments role would be hard to overcome. She spoke at a forum sponsored by the Kaiser Family Foundation.
Most Americans may not realize it, but government already pays nearly half of the nations health care tab. Government programs cover seniors, poor families, and many children. Obama has proposed to expand that.
His plan would offer middle class workers and their families the option of enrolling in a public plan, along with private insurance, through a new kind of purchasing pool. But Obama has avoided filling in the details, thereby giving himself some room to compromise.
Those details would be critical, according to a recent economic study. The Lewin Group, a consulting firm, found that a public plan would help to significantly reduce the number of uninsured. But depending on how its designed, it could also take away much of the business from private insurers.
If a public plan was open to all employers and individuals, and paid doctors and hospitals the same low rates as Medicare, it would become the dominant insurer in the country, the study found. But if the plan were open only to individuals and small businesses, and paid rates similar to private insurers, its impact would be limited. In that case, the public plan would mainly be helping groups that now have a hard time getting private coverage.
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On the Web:
DeParle news conference: http://tinyurl.com/dhwj8s
Company Says Prostate Cancer Vaccine Shows Guarantee
Seattle-based Dendreon Corp. said that its Provenge cancer vaccine improved overall survival when compared to a dummy treatment in a study of 512 men with advanced disease.
No survival details or information on side effects were given. Full results will be presented at an American Urological Association meeting later this month, and Dendreon said it would seek federal approval of the treatment later this year.
Provenge is not like traditional vaccines that prevent disease. Its a so-called therapeutic vaccine that treats cancer by training the immune system to fight tumors. If approved, Provenge would be the first such treatment on the market.
This is the second major study in which Provenge has shown a survival benefit, leading some scientists to hope not just for its approval but for a new approach to fighting cancer beyond the surgery, radiation, hormones and chemotherapy used now.
“This is an exciting result, demonstrating that harnessing a patients own immune system can successfully attack prostate cancer,” said Dr. Eric Small, cancer specialist at the University of California at San Francisco. “Now we have more confidence that the initial results we saw were real.”
He enrolled some patients in the new study and led the earlier one, but has no financial ties to the company or the vaccine.
In the earlier study of 127 men, those treated with the vaccine lived an average of 4 1/2 months longer than those given dummy treatments. After three years, survival was 34 percent in the vaccine group and only 11 percent in the other.
Those results led advisers to the Food and Drug Administration to recommend Provenges approval two years ago. But the FDA delayed action and asked for more data, because extending survival wasnt the main goal of that study – slowing progression of the cancer was, and the vaccine failed to do that.
The decision sparked protests from mens groups and cancer advocates because the vaccine did prolong survival, which they considered a more important result.
On Tuesday, results of the new study boosted Dendreon stock by $9.69, closing at $16.99, more than doubling in value as investors bet on improved chances of FDA approval and the potential for a lucrative market.
Provenge is a treatment that is customized for each patient. Doctors collect specialized cells from each patients blood. Those cells help the immune system recognize cancer as a threat, much as it would germs that enter the body.
The cells are mixed with a protein found on most prostate cancer cells to help activate the immune system. The resulting “vaccine” is given back to the patient as three infusions two weeks apart.
If Provenge proves safe and wins approval, “it would be an important breakthrough,” said Dr. William Oh, a cancer specialist at Dana-Farber Cancer Center in Boston. Three years ago, he consulted for Dendreon on the vaccine but has had no financial ties to it since then.
“There are so few treatments available” for men whose prostate cancer has spread widely – a situation that affects 40,000 to 60,000 American men, he said.
Prostate cancer is the most common non-skin cancer in American men. An estimated 186,000 new cases and 28,660 deaths from it occurred last year.
Botoxs First Major Adversary Faces Delay In Fda Advertising Approval
Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.s Botox.
Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.
Nachman and other analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins.
The FDA delayed a decision on Dysport, Ipsens version of Reloxin for medical uses, in December to finish work on a risk- management program to ensure safe use.
Medicis, of Scottsdale, Arizona, has rights to sell Reloxin in the U.S. Approval would trigger a $75 million payment to Ipsen, which developed the drug.
Fashionable Drug
Allergan, which got 32 percent of its revenue from Botox sales in last years fourth quarter, is cutting 5 percent of its workforce this year to brace for the prospects of new competition and lower demand for cosmetic procedures in the recession.
Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.
Botox earned $1.31 billion for Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.
The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.
Galderma, a joint venture between Nestle SA and LOreal SA, has European marketing rights to a version of Dysport for aesthetic uses, called Azzalure. Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.
Erection Drugs Viagra, Cialis Didnt Show Eye Damage In Study
The erection drugs can cause changes in light perception right away that clear a few hours later, said Raj Maturi, an author of the Lilly-funded research and an ophthalmologist at the Indiana University School of Medicine in Indianapolis.
The study, published online today in the Archives of Ophthalmology, found no evidence of permanent visual changes in patients who took the drugs every day for six months, Maturi said. About 6.2 percent of U.S. men are unable to achieve an erection, with rates rising to 16.7 percent in ages 60 to 69, according to the National Institutes of Health.
“The average patient should be relieved these drugs dont cause significant visual dysfunction,” Maturi said in a telephone interview today. “And he can be comfortable taking them in the long-term.”
The study was sponsored by Indianapolis-based Lilly, which also helped design the research, collect the data and prepare the manuscript. Viagra had sales of 1.9 billion last year for Pfizer, based in New York. Cialis revenue was $1.2 billion for Lilly.
Drug Actions
The chemicals in Viagra and Cialis act on compounds in the blood vessels of the penis, allowing for more blood flow that can lead to an erection, according to background information in the article. Similar compounds exist in the eye.
Researchers examined 244 men, ages 30 to 65, using a test that measured the electrical impulses from their eyes, as well as comprehensive ophthalmologic exams. A third of the patients took Viagra, a third took Cialis and a third took a placebo.
Each patient visited the examiners six times, and were screened before the study began, halfway through the study, and twice after the study was over.
The exams turned up no cases of a rare optic nerve disease that can cause vision loss in one eye, the authors wrote. The ailment, called non-arteritic anterior ischemic optic neuropathy, is caused by lowered blood pressure. A European advisory panel said in 2006 that people with the disorder shouldnt take erectile-dysfunction drugs.
The study didnt aim to find cases of the disease, Maturi said.
The research was done in healthy men, some of whom had mild erectile dysfunction, Maturi said. The results may not apply to patients with diabetes, who may be more sensitive to lowered blood pressure that could damage the optic nerve, the authors wrote.
Study: Best Science On Heart-healthy Foods Percent Toward Veggies, Nuts
Thats the conclusion of new research based on an analysis of nearly 200 studies involving millions of people.
Vegetables, nuts and the Mediterranean diet made the grocery list of “good” heart foods. On the “bad” list: starchy carbs like white bread and the trans fats in many cookies and french fries.
The “question mark” list includes meat, eggs and milk and many other foods where theres not yet strong evidence about whether theyre good or bad for the heart.
“I do research. I also buy groceries for my family every week,” said study co-author Dr. Sonia Anand of McMaster University in Hamilton, Ontario, who hopes the findings “decrease the confusion around what we should eat and what we shouldnt eat.”
The study, appearing in Mondays Archives of Internal Medicine, doesnt actually read like a shopping list. Its a complicated explanation of how the researchers rated 189 prior studies on the topic.
In short, they used criteria developed by Sir Austin Bradford Hill, the late British scientist who helped establish a link between smoking and lung cancer. When multiple studies on a certain food or diet showed a strong link with better heart health, that put the food or diet at the top of the list.
Dr. JoAnn Manson, chief of preventive medicine at Harvards Brigham and Womens Hospital, said the analysis underlines that theres a big gray area and a shorter list of foods with strong links to heart health.
Linda Van Horn, professor of preventive medicine at Northwestern Universitys Feinberg School of Medicine, said the analysis is more about the strengths and limits of previous studies than advice for consumers.
But she said the analysis reaffirms the benefits of a Mediterranean diet – rich in vegetables, nuts, whole grains, fish and olive oil – compared to a Western diet, heavy on processed meats, red meat, refined grains and high-fat dairy.
Beyond that, she found no reason to tear up your grocery list based on the findings.
“Its really about the totality of the usual eating pattern, rather than whether you ate a hot dog on opening day of baseball season,” Van Horn said.
The Heart and Stroke Foundation of Canada and the Canadian Institutes of Health supported the research.
On the Net:
Archives: http://www.archinternmed.com
Cdc: Us Nourishment Poisoning Cases Held Steady In 2008
But produce-associated food poisonings have been increasing, and the nation is no longer whittling down food-borne disease, government officials said.
“Progress has plateaued,” said Dr. Robert Tauxe of the U.S. Centers for Disease Control and Prevention, a co-author of the report.
The report looks at the occurrence of about ten leading food-borne illnesses in ten states that participate in a federally-funded food poisoning monitoring system. CDC officials believe its nationally representative, based on the samples mix of geography and demographics.
The research appears in this weeks issue of a CDC publication, Morbidity and Mortality Weekly Report.
Salmonella remained the most common cause of food poisoning, triggering more than 7,400 lab-confirmed illnesses in those states. That translates to a rate of about 16 cases for every 100,000 people. There has been no significant change in the salmonella rate in recent years, CDC officials said.
Campylobacter and shigella, two kinds of bacterial infections, were the second and third most common food-borne illnesses, occurring at rates of about 13 and 7 per 100,000, respectively.
The researchers dont address how many people died.
Experts say the reports numbers are lower than reality because only a fraction of food poisoning cases get reported or confirmed by laboratories.
An estimated 87 million cases of food-borne illness occur in the United States each year, including 371,000 hospitalizations and 5,700 deaths, according to an Associated Press calculation that used the CDC formula and current population estimates.
There were geographic variations in disease rates among the states, the CDC found. The highest rates of salmonella occurred in Georgia and New Mexico, campylobacter was most common in California and E. coli thrived best in Colorado.
Those variations were no doubt influenced by some specific outbreaks that caused more illnesses in some states than others, said Elliot Ryser, a professor of food science at Michigan State University.
Prominent food-borne illness outbreaks in 2008 included:
-A peanut-related salmonella outbreak – which started last year – caused at least 690 confirmed illnesses in 46 states and was linked to nine deaths.
-A salmonella outbreak attributed to Honduran cantaloupes sickened 51 people in 16 states.
Better testing and surveillance has improved the governments ability to detect food-borne disease outbreaks, Ryser said.
Outbreaks account for just a fraction of cases in the ten states last year, however. For example, only 7 percent of the salmonella cases were tied to identified outbreaks, the CDC report said.
The food supply is safer today than it was 50 or 100 years ago, thanks to advances like pasteurization and cleaner water, said Tauxe, deputy director of the CDCs Division of Foodborne, Bacterial and Mycotic Diseases.
Fda Reversal Oks Morphine Painkiller For Dying
But on Thursday, the FDAs Dr. Douglas Throckmorton told The Associated Press the morphine liquid will remain on the market until its replaced by an approved version or some equivalent therapy.
The reversal was welcomed by experts in hospice care and pain relief. One doctors group had told the FDA that last weeks order would “cause extreme suffering for many patients who are nearing the end of life.”
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agencys Center for Drug Evaluation and Research.
The agency said last week that the unapproved drugs might be unsafe, ineffective or poor quality. The order gave manufacturers 60 days to stop making those products.
The liquid morphine is highly concentrated. Other approved forms of liquid morphine are more dilute, and Throckmorton said the FDA had thought the other forms could take the place of the concentrated form.
But reaction from hospice experts and others “helped us understand” that some patients need the unapproved version, Throckmorton said.
In interviews, experts said they didnt have firm numbers on how many patients use the concentrated liquid. But Dr. Diane Meier, director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine in New York, estimated that it may be at least 2 million Americans a year.
She called Thursdays decision “fabulous…. Its incredibly refreshing and makes me hopeful about our government.”
The high morphine concentration is crucial, she and others said. It allows caregivers to rapidly relieve pain by placing just a few drops in the mouth of a person who has trouble swallowing, perhaps because of confusion, lethargy or other conditions.
The more dilute morphine requires much more liquid, which could make an impaired person choke or sputter, or refuse to take the medication, experts say.
Caregivers can administer the concentrated solution at home, where morphine shots often arent a good option. Without the concentrated liquid, families could end up calling 911 to rush their loved ones to an emergency room for morphine shots, which would be expensive and against patient wishes, said Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine.
Storey called the FDA reversal “a really important step in the right direction,” showing “an amazing level of responsiveness were not used to seeing in our government officials.”
While approved medications with those ingredients remain on the market, Storey noted that opiate painkillers are in short supply. So rather than removing the unapproved versions all at once, exacerbating the problem, he suggested the FDA proceed more slowly.
In a letter to the FDA earlier this week, Storeys organization said the painkillers covered by last weeks order “have been used safely and effectively for decades.”
Throckmorton said the FDA is open to getting additional information about the other painkillers, and would discuss them with experts in hospice and palliative care.
But Storey said that in a later phone call with physicians and pharmacists, the FDA said that the order against the other painkillers would stand.
Further shortfalls in painkiller supply could spell trouble for chronic pain patients such as 62-year-old Ora Chaikin in New York City, said her physician, Dr. R. Sean Morrison at Mount Sinai.
Genentech Withdraws Psoriasis Drug Linked to Brain Infections
Genentech, the biotechnology company acquired last month by Swiss drugmaker Roche Holding AG, has told doctors not to write prescriptions for new patients as part of a phased withdrawal of Raptiva to be completed by June 8, the South San Francisco-based company said yesterday in a statement. About 2,000 U.S. patients may be taking Raptiva, Genentech said
The decision to withdraw the drug, which generated $108 million in U.S. sales for Genentech last year, came after three patients were diagnosed since October with the brain infection progressive multifocal leukoencephalopathy, two of whom died, said Tara Cooper, a Genentech spokeswoman. The risk of PML, which causes irreversible brain damage, outweighed Raptivas benefits in controlling psoriasis, the company concluded.
“We said, and the Food and Drug Administration agreed, that Raptiva likely causes PML,” said Ivor Caro, Genentechs senior medical director for dermatology, in a telephone interview. What tipped the balance was that Genentech could neither predict which patients were likely to develop PML, nor come up with a strategy to lessen that risk, he said.
“It was the clinical science perspective, not how much Raptiva was being sold,” Caro said.
$125 Million Charge
The withdrawal will result in a one-time charge of about $125 million, the company said.
Raptiva, approved in 2003, was designed to suppress the abnormal immune response that triggers psoriasis, a painful, scaly rash that afflicts about 7.5 million Americans, according to the National Psoriasis Foundation. Sales never took off as other anti-inflammatory medicines, including Amgen Inc.s Enbrel, Johnson & Johnsons Remicade and Abbott Laboratories Humira, entered the psoriasis market.
“Most people could see this coming,” said Eric Schmidt, a biotechnology analyst with Cowen & Co. in New York in a telephone interview. ” We knew this drug had a severe side- effect profile, and its efficacy isnt that good.”
A fourth patient on Raptiva, who developed worsening neurologic symptoms, also died of unknown causes, the company said.
At least four other drugs have been linked to PML risk. They include Roches Cellcept, used to prevent transplant rejections; Biogen Idec Inc. and Genentechs cancer drug Rituxan; Biogens multiple sclerosis treatment Tysabri and Genzyme Corp .s leukemia drug Campath.
No Other Withdrawals
“I see zero impact” he said. “Rituxan treats cancer. Tysabri, multiple sclerosis. The risk benefit for using Rituxan and Tysabri for their respective indications is very favorable. Thats different from the profile for Raptiva, which Genentech decided is borderline.”
PML occurs when a common germ, called JC virus, mutates, then evades the bodys immune defenses and penetrates the brain. People with suppressed immune systems are most at risk for PML.
Biogen, based in Cambridge, Massachusetts, has been testing a malaria drug and a blood-cleansing therapy as treatments for the deadly brain infection.
Biogens multiple sclerosis drug Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced a year later when U.S. regulators said the medications effectiveness, twice that of other MS drugs, outweighed its risks. Five cases of PML in Tysabri users have been reported since July.
Genentechs Caro said the company contemplates no similar withdrawal action for its Rituxan drug, which is used to treat non-Hodgkins lymphoma.