Testing Prototype Myeloma Medication
For some people the prospect of a prototype medication can be hopeful, and testing can be done with the consent of the patient and corporations involved.
Baron has described Tysabri as a “last chance effort for life” in his 61-year-old fathers battle with late-stage multiple myeloma. Doctors last week gave Fred Baron only days to live, his son said. Tysabri is approved for people with multiple sclerosis or Crohns disease, but is only in the early clinical trial stage for multiple myeloma.
Patients can seek to use drugs outside the authorized use under what the Food and Drug Administration calls single-patient investigations. But permission must ultimately come from the drug manufacturer, said Judy Leon, an FDA spokeswoman. Biogen Idec Inc., which manufactures Tysabri, didnt grant permission to treat Fred Baron with the drug, company spokeswoman Naomi Aoki said late Thursday.
Biogen has maintained the regulatory risks of giving him special access to Tysabri are too great. The company stood by its decision despite appeals from such prominent figures as former President Bill Clinton and cyclist Lance Armstrong. Andrew Baron said the Mayo Clinic, working with the FDA, found a legal basis for using Tysabri on his father. Mayo Clinic spokesman John Murphy said he had no information about the case. Leon said the FDA could not comment on individual cases, but said no preferential treatment had been given to Baron.
The FDA approved about 250 single-patient investigations in 2007, Leon said. Fred Baron has bankrolled millions for Democrats in Texas. He made headlines this summer when he acknowledged sending money to Edwards former mistress. Baron has said Edwards had no involvement with the payments, which were used to resettle Rielle Hunter, Edwards former mistress, in California. Aoki has said there is no data showing Tysabri would work in Fred Barons case.
He was turned down for the companys clinical trial, but Aoki said she could not say why. Aoki said Tysabri was first approved for multiple sclerosis in 2004, then pulled from the market after three people taking the drug suffered a rare brain infection. Two died, she said.
Source: mibax
New Generation Biological Drugs Saftey Testing
New generation biological drugs have at times experienced safety concerns, a few companies have even issued warnings a short time after the product entered the market. More thorough testing before approval by government agencies would prevent that scenario from happening.
That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.
Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.
Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.
The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.
The drugs are known as biologicals because theyre made from living material and they typically affect the bodys disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
Its that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.
Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows thats not necessarily true.
“They have an important role,” Bennett said. “Theyre really the next generation of pharmaceuticals.”
He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.
Among the drugs under examination are Genentech Inc.s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.
The study appears in Wednesdays Journal of the American Medical Association.
The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.
But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.
“If most issues are discovered within the first few years, then the system is working,” Giezen said.
Bennett says its unreasonable to think that the studied drugs safety issues should have been discovered before they were marketed. Thats because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.
Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.
Source: mibax
Canandian Ban on BPA For Food and Infant Items
The controversial chemical added to plastics is facing a ban in Canada. Infant and food items with BPA are expected to see a reduction or complete phase out.
“Many Canadians…have expressed their concern to me about the risks of bisphenol A in baby bottles,” Environment Minister John Baird said in a statement. “Todays confirmation of our ban on BPA in baby bottles proves that our government did the right thing in taking action to protect the health and environment for all Canadians.”
Canadas announcement came six months after its health ministry labeled BPA as dangerous. Health Minister Tony Clement said a report on bisphenol A has found the chemical endangers people, particularly newborns and infants, and the environment, citing concerns that the chemical in polycarbonate products and epoxy linings can migrate into food and beverages.
Baby bottles frequently contain BPA, used to harden plastic and make it shatterproof.
Several U.S. states are considering restricting BPA use, some manufacturers have begun promoting BPA-free baby bottles, and some stores are phasing out baby products containing the chemical. Wal-Mart Canada and other major retailers in Canada in recent months have begun removing BPA-based food-related products such as baby bottles and sipping cups from store shelves.
The scientific debate over BPA could drag on for years. The European Union and the U.S. Food and Drug Administration say the chemical is safe. However, the FDA is awaiting word from a scientific panel expected to deliver an independent risk assessment later this month.
The chemicals industry maintains that polycarbonate bottles contain little BPA and leach traces considered too low to harm humans.
Robert Brackett, chief science officer for the Grocery Manufacturers Association, said Friday that Canadas precautionary action regarding the use of BPA is disproportional to the risk determined by public health agencies.
The biggest concern with this widely used chemical, traces of which can be found in more than 90 percent of Americans, has been over BPAs possible effects on reproductive development and hormone-related problems.
Source: mibax
Hope With Cancer, Active Lifestyle
Coping with an illness like cancer is easier with hope, and an active lifestyle. Here are some thoughts by someone going through the experience.
I had even pinned my number to my shirt in advance. Alone, in silence, I ate a banana and a granola bar and half a bagel. Exactly as planned.
I thought to myself: I need this routine. I need to be a robot today.
Nearly five years before this day, before I started running, I had been diagnosed with melanoma skin cancer in my left shin. Then, much later, came the thyroid cancer; they found that one looking for more melanoma. I was 51 and I had two forms of cancer. Now here I was in the middle of chemotherapy – weakened, scared, with more chemo scheduled for the following day. And I was heading out to run a half-marathon on the streets of Philadelphia.
What was I thinking?
I arrived at the starting gate and joined the pack of runners. The sun was coming up. Nearby, I could see the citys art museum, where Rocky climbed the steps in triumph so many years ago.
I never heard the starting gun, but the people ahead of me began to move.
I clicked my iPod. My song came on – “Gonna Fly Now,” Rockys inspiration. Appropriate for Philadelphia, for this race and for me. The tears started coming, as they often do when I begin a run. I brushed them away because I didnt want to irritate my contacts.
And then I ran. Exactly as planned.
I was running for my life, in a sense, though I knew that competition was really unfolding inside my body, far beyond my control. I was running in affirmation, in defiance. I was running to prove that I could, to show that I was not defined by the clusters of renegade cells that were growing within me.
To deal with something in my life that has not, in any conceivable way, gone exactly as planned.
—
Two cancers, actually. Theyre unrelated, which is good. There are two of them, which isnt.
The National Cancer Institute estimates that among the 10.1 million cancer survivors that were alive as of January 1, 2002, about 8 percent had more than one form of cancer diagnosed between 1975 and 2001. Three cancers is “almost unheard of,” one doctor told me. I guess I should be thankful for that.
This year, 62,480 cases of melanoma, the most serious form of skin cancer, are expected in the United States and 37,340 cases of thyroid cancer. While my melanoma was a recurrence, I still saw it as unfair: Fewer than 100,000 people in this country got one of those cancers; I, a regular tennis player and nonsmoker, got both.
The melanoma begat two surgeries – one to take it out and one to make sure it hadnt spread. Whats more, I was informed that I could develop lymphedema, a sometimes painful swelling of the leg due after surgery that happens because the lymphatic system has been compromised.
“Unless you want a fat leg, stay on the couch with your leg up. No running and very limited exercise,” one oncologist, considered among the best melanoma doctors in the world, told me.
Source: mibax