10 fatal drugs approved by FDA
Merck’s Vioxx, a nonsteroidal anti-inflammatory (NSAID) painkiller, made headlines in 2004 when the company voluntarily withdrew it from the U.S. market following reports of increased rates of strokes and heart attacks in patients taking the drug chronically. Vioxx was the most famous of more than a dozen drugs withdrawn from the market since 2000.
But withdrawal of drugs is not a new phenomenon. In fact, the Food and Drug Administration (FDA) took on its modern form as a reaction to the horrific side effects of the drug thalidomide, introduced in Europe in the 1950s as a sleep aid and treatment for morning sickness in pregnant women.
By 1962, it was evident that thalidomide caused severe limb deformities, and Frances Kelsey, the FDA’s medical officer at the time, kept the drug off of the market. In Europe, 8,000 babies were born with defects resulting from the drug. That tragedy prompted a Congressional bill that gave the FDA the authority to raise the safety bar and require that companies prove the effectiveness of drugs before they could be marketed in the United States.
FDA failures
Recently, the FDA has come under attack for not living up to its mission. The agency failed to catch serious side effects in a number of drugs before they were approved, thus forcing embarrassing withdrawals.
Critics attribute these failures to the agency’s close ties with the medical industry. These close ties are exemplified by the 1992 Prescription Drug User Fees Act, which requires industry to pay user fees that help fund the agency’s review of new drugs for approval.
Part of the purpose of the legislation was to shorten the approval times and get drugs to market more quickly. But according to a 2002 report by the Government Accounting Office (GAO), the legislation ultimately caused increased workload for the FDA’s reviewers. There was also a slight increase in the percentage of drugs that had to be withdrawn from the market.
The side effect of withdrawing drugs
The flip side of the decision to withdraw a drug due to rare, serious side effects is that it can leave some patients with few therapeutic options. For example, some patients objected to the withdrawal of Zelnorm, a drug used to treat irritable bowel syndrome.
Seriously ill patients “should be able to take a risk,” says Peter Barton Hutt, senior counsel at the law firm Covington & Burling LLP, and former FDA chief counsel.
But Diana Zuckerman, president of the National Research Center for Women & Families, argues that it isn’t that simple.
“The problem is that patients aren’t really told ([about a drug’s risks). Doctors aren’t giving that information, partly because they don’t spend that much time with patients and partly because they don’t know themselves—they haven’t read all 10 studies (performed on a drug).”
The FDA’s Hall of Shame
Vioxx
What it is: Vioxx is a COX-2 selective nonsteroidal anti-inflammatory (NSAID) painkiller related to drugs such as ibuprofen and naproxen.
Why it was taken off the market: The result of a clinical study showed an increased risk of serious cardiovascular events such as heart attacks and strokes.
Expiration date: Merck withdrew Vioxx from the worldwide markets in 2004.
Bextra
What it is: Like Vioxx, Bextra is an NSAID painkiller.
Why it was taken off the market: Two short-term studies indicated potential increases in cardiovascular events such as heart attacks and strokes and increased risk of serious skin reactions. The FDA also concluded that Bextra had no unique advantages over other NSAIDs. FDA scientists decided that the known cardiovascular risks of other NSAIDs demonstrated in long-term trials justified a request for withdrawal.
Expiration date: Pfizer withdrew Bextra from the U.S. market in 2005.
Zelnorm
What it is: Zelnorm is a drug to treat irritable bowel syndrome (IBS).
Why it was taken off the market: 29 studies showed that 13 of 11,614 patients taking the drug had heart problems. One of 7,031 patients on placebo experienced the problem. About 500,000 people were taking the drug at the time of its withdrawal. Novartis continues to market the drug in Europe, citing its belief that the trial results were a fluke.
Expiration date: Novartis withdrew Zelnorm from U.S. markets in March 2007. IBS patient groups objected to the withdrawal, arguing that the benefits outweighed the risks. The FDA responded to complaints from patients and physicians by creating a restricted-access program for patients that have no therapeutic alternatives or who had satisfactory outcomes on previous treatment with Zelnorm.
Tysabri
What it is: Tysabri is a drug that treats multiple sclerosis.
Why it was taken off the market: After three patients in a clinical study developed progressive multifocal leukoencephalopathy (PML, a serious brain infection), the FDA halted trials of the multiple sclerosis drug until the company could prove that no additional cases of PML had occurred.
Expiration date: Biogen-Idec withdrew Tysabri from the worldwide market in 2005. In 2006 it was allowed back on the market with a risk-minimization program with mandatory patient registration and follow-up.
NeutroSpec
What it is: NeutroSpec is an antibody labeled with a radioactive marker that was used to diagnose appendicitis in patients that show some but not all of the clinical signs of appendicitis.
Why it was taken off the market: While the agent was on the market, 17 patients who received NeutroSpec experienced life-threatening side effects soon after it was injected, including shortness of breath, low blood pressure, and cardiac and pulmonary arrest. Two patients died. About 11,000 patients received NeutroSpec while it was on the market.
Expiration date: Palatin Technologies withdrew NeutroSpec from the U.S. market in 2005.
Cylert
What it is: Cylert is a drug used to treat Attention Deficit Hyperactivity Disorder (ADHD).
Why it was taken off the market: The FDA learned of 13 reports of liver failure leading to liver transplant or death. The number of cases reported was small, but patients taking the drug had a liver failure rate of 10-25 times the rate of liver failure in the general population.
Expiration date: Abbott withdrew Cylert from the U.S. market in 2005.
Permax
What it is: Permax is a drug used to treat Parkinson’s disease.
Why it was taken off the market: Two studies confirmed previous findings that Permax is associated with increased chance of blood backflow to aortic valves of the heart. Symptoms include shortness of breath, fatigue and heart palpitations. In 2006, about 12,000 patients received prescriptions in the US.
Expiration date: In 2007, Valeant Pharmaceuticals voluntarily withdrew Permax from the U.S. market. Two other companies, Par and Teva, withdrew generic versions.
Baycol
What it is: Baycol is a cholesterol-lowering drug.
Why it was taken off the market: Reports of sometimes fatal rhabdomyolysis—a severe muscle condition. All statins cause rare cases of rhabdomyolysis, but Baycol patients experienced it at a significantly higher rate than patients on other statins. The FDA received reports of 31 deaths related to Baycol.
Expiration date: Bayer withdrew Baycol from the U.S. market in 2001.
Palladone
What it is: Palladone is a narcotic painkiller in a slow-release capsule.
Why it was taken off the market: Severe side effects were reported when Palladone was taken with alcohol. Alcohol use caused high levels of the drug in the body, with potentially fatal effects such as the depression or halting of breathing and coma.
Expiration date: Purdue Pharma withdrew Palladone from the U.S. market in 2005.
Source health.msn.com
Miraculous neoplasm surgery - six organs taken away
MIAMI — Lodged behind several organs and attached to arteries, the lemon-sized tumor in Brooke Zepp’s abdomen appeared to be inoperable. It was malignant and out of reach.
But on Monday, Ms. Zepp watched in awe as doctors at the University of Miami/Jackson Memorial Medical Center explained how they detached and removed six of her organs, cut out the cancerous tumor, then reassembled her insides. With a video of the March 4 operation on display at a news conference here, she wiped away tears and said: “I feel like I’m coming through the tunnel and I have a whole life.”
Her doctors smiled with pride. The surgery lasted 15 hours and was one of the first to involve taking so many organs out of the body: the stomach, liver, pancreas, spleen, small intestine and two-thirds of the large intestine.
Dr. Tomoaki Kato, a transplant specialist who led the team of at least nine doctors, said he hoped the procedure would be duplicated for other cancer patients and those with aneurysms or other problems associated with the abdominal aorta.
It remains unclear how often it would be needed; tumors like Ms. Zepp’s are rare, and in most abdominal surgeries, organs can be lifted or held aside.
But in the case of Ms. Zepp, 63, there was no other way to reach the tumor. After she received a diagnosis in May, doctors discovered that the cancerous tissue was entwined with several blood vessels and buried deep within.
“It wasn’t so big, but it was in a very strategic location,” said Dr. Andreas Tzakis, director of the hospital’s Transplant Institute and a member of the operation team.
Dr. Tzakis said doctors essentially had to empty Ms. Zepp’s abdomen. Then they cut out the tumor and its attached blood vessels in a matter of minutes.
Next, the team sewed in white Gore-Tex tubes to replace involved sections of the arteries, and went to work putting Ms. Zepp back together. The removed organs sat in a large, square metal tin — roughly the size of a turkey pan — for about 90 minutes before the surgeons began to reinsert and reattach them. In the video, they could be seen sloshing in cool water, like leftover soup.
Ms. Zepp, a real estate agent from Pompano Beach, shook her head when she saw her organs.
“I’m glad I had a good anesthesiologist,” she said. (Actually, according to her doctors , there were two.)
Dr. Kato said the surgery was possible only because of the hospital’s experience with transplants. For more than a decade, he said, doctors have been expanding their knowledge of how long people can live without certain organs, and how to work on them outside the body.
In 2000, Dr. Michael J. Reardon, a surgeon in Houston, removed a patient’s heart, cut out four tumors, then sewed it back in. The patient died nine months later after the cancer recurred — a risk also faced by Ms. Zepp.
For now, she said she considered herself ready to live until age 100.
Dr. Reardon, an expert in cancer surgery, said the procedure was astounding.
“It’s a heck of a big operation,” Dr. Reardon said. “Putting that much back in would be a real surgical tour de force.”
VIA - NY Times
Normal blood pressure is affected by unhappy marriage
NEW YORK - A happy marriage is good for your blood pressure, but a stressed one can be worse than being single, a preliminary study suggests.
That second finding is a surprise because prior studies have shown that married people tend to be healthier than singles, said researcher Julianne Holt-Lunstad.
It would take further study to sort out what the results mean for long-term health, said Holt-Lunstad, an assistant psychology professor at Brigham Young University. Her study was reported online Thursday by the Annals of Behavioral Medicine.
The study involved 204 married people and 99 single adults. Most were white, and it’s not clear whether the same results would apply to other ethnic groups, Holt-Lunstad said.
Study volunteers wore devices that recorded their blood pressure at random times over 24 hours. Married participants also filled out questionnaires about their marriage.
Analysis found that the more marital satisfaction and adjustment spouses reported, the lower their average blood pressure was over the 24 hours and during the daytime.
But spouses who scored low in marital satisfaction had higher average blood pressure than single people did. During the daytime, their average was about five points higher, entering a range that’s considered a warning sign. (That result is for the top number in a blood pressure reading).
“I think this (study) is worth some attention,” said Karen Matthews, a professor of psychiatry, psychology and epidemiology at the University of Pittsburgh. She studies heart disease and high blood pressure but didn’t participate in the new work.
Few studies of the risk for high blood pressure have looked at marital quality rather than just marital status, she said.
It makes sense that marital quality is more important than just being married when it comes to affecting blood pressure, said Dr. Brian Baker, an associate professor of psychiatry at the University of Toronto.
Source - [Yahoo!News]
Could power of literacy affect your health?
Want your children to grow up to be healthy, wealthy and wise?
Then read them a book.
Read them a book every night before bed. Read along as they discover the wonders of the alphabet and their first words. Steer them toward computer games that require some literacy, not just thumb dexterity.
As they grow up, help them discover books that engross them, such as the Screech Owls series, or the Amos Daragon collection. Have newspapers and magazines around the house. Lead by example, turn off the television and read a book yourself.
Do everything in your power to help them stay in school and go on to college or university.
While we obsess about our weight, blood pressure and cholesterol levels, the single best predictor of good health and longevity is probably literacy.
Literacy is the foundation of a good education and educational achievement is a good predictor of income. That trio - literacy, education, income (not to mention housing and a good physical environment, which flow from income) are powerful determinants of health.
And we were reminded this week, in a series of studies, just how powerful those factors can be for our individual and collective health.
While life expectancy has been rising steadily for decades, new research published this week in the journal Health Affairs shows those gains have occurred exclusively in people who have a post-secondary education.
Once you study in college or university, your life expectancy soars by about seven years, the study showed. Conversely, having only a high-school education puts you on the fast track for an early death.
Canada’s census also provides some intriguing data on the topic. British Columbia, by most measures, has the healthiest population in the country. This is usually attributed to the mild West Coast weather and the preponderance of granola types.
But the census tells the real story: British Columbia has the most educated population. Only 12 per cent of adults in the province have not completed high school. By comparison, the rate is 15 per cent in Alberta, 17 per cent in Quebec, 26 per cent in Newfoundland and Labrador, and 46 per cent in Nunavut, which, not surprisingly, has the lowest life expectancy in the country.
While we are increasingly dependent on technology, the ability to read, count and comprehend the written word remains fundamental. Being illiterate, innumerate or uneducated virtually condemns one to poverty and poor health.
Literacy is not only a key factor in obtaining a good job (and the health advantage that comes with income) but, increasingly, being literate is essential to managing one’s health, even for those with an education.
In an era where much “care” is delivered in seven-minute visits to the family doctor or, worse yet, by anonymous doctors in high-churn walk-in clinics, and where ever-increasing numbers of people are living with dizzying combinations of chronic illnesses, patients need a broad set of skills to keep pace.
They need to be able to understand drug dosing and schedules, monitor everything from blood sugar to blood gases. They need to decipher the gobbledygook that doctors too often spew out, and to suss out information on reliable websites such as the Canadian Health Network (canadian-health-network.ca).
In other words, modern health consumers need health literacy - the ability to find, understand and use health information.
Yet, according to a new report, we are a nation of health illiterates: Fewer than half of Canadians (45 per cent) have the skills to deal with basic and routine health information demands.
More troubling still, only about 12 per cent of seniors - those most likely to use health-care services regularly - can cope with the health information demands placed on them.
“There are higher information demands being put on Canadians by an increasingly complex health system,” said Irving Rootman, a professor in the department of human and social development at the University of Victoria and co-author of the new report, titled A Vision for a Health Literate Canada. (The co-author is Deborah Gordon-El-Bihbety, the president and CEO of Research Canada.)
They make a compelling case for making health literacy a priority, particularly among those who are already disadvantaged - the elderly, the poor, immigrants, aboriginals.
The report notes that those with the lowest health literacy skills are about 2.5 times more likely to be in poor health than those with the highest literacy levels, and that those who are ill-equipped to deal with the demands of their care actually cost significantly more to care for.
But the bottom line is that health literacy is an issue of social justice and that a medicare system worthy of its name needs to promote literacy, because it is a virtual prerequisite to good health.
Source - [Globeandmail.com]
Blood thinner Heparin is tested by FDA
WASHINGTON - The government is ratcheting up testing of the blood thinner Heparin and its main ingredient, as new evidence pointed to China as the source of the tainted drug that killed as many as 21 Americans.
The Food and Drug Administration is now making sure that all supplies of Heparin and its key ingredient are tested for the mysterious contaminant, agency officials told reporters yesterday. Manufacturers and importers will have to conduct the sophisticated tests or government inspectors will do so before the products can be distributed in the United States.
“At our borders either we will be testing or we will be receiving results,” said Dr. Janet Woodcock, who directs the FDA’s drug division.
The agency announced the new steps as 20 of 28 samples taken from a suspect manufacturing plant in Changzhou, China, tested positive for the contaminant, Woodcock said.
That disclosure adds to suspicions that the contaminant was introduced during manufacture in China rather than during processing in the U.S., although FDA officials emphasized that their investigation is wide-ranging and continuing.
The contaminant mimics Heparin’s key ingredient and evades detection by routine quality testing. Investigators are trying to determine whether the look-alike was added intentionally - and fraudulently - and whether it caused the more than 700 reports of serious side effects.
Woodcock said the twin mysteries should get answered soon, once scientists figure out exactly what the contaminant is. “When we understand it, it’s really going to help us figure out how it got in there,” she said, saying the agency is “very close to nailing this down.”
After reports of Heparin-users experiencing plunging blood pressure, chest pains and dizziness, Baxter International Inc. recalled virtually all its Heparin products last month. Baxter scientists have ruled out common bacterial sources of contamination, such as the pertussis, botulinum, diphtheria, cholera and tetanus toxins, but that still leaves a range of natural and synthetic causes, a spokeswoman said.
Since the company’s Feb. 28 recall, the FDA has received just two reports of side effects, neither fatal. “Doctors should reassure patients,” Woodcock said.
The scare has spread globally, with authorities in Germany and Japan issuing recalls. Those countries are also testing Heparin products for the contaminant, FDA officials said.
Baxter bought the main Heparin ingredient from Scientific Protein Laboratories, a Wisconsin company that co-owned the Changzhou plant in eastern China. The Changzhou plant is no longer allowed to ship products to the U.S., Woodcock said, and FDA inspectors have been ordered to stop all other Heparin imports to make sure they have undergone the sophisticated testing for the contaminant.
Meanwhile, the five leading makers of Heparin and its key ingredient have committed to testing all of their supplies, said Steve Silverman, an FDA compliance official.
Critics have attacked the FDA for failing to inspect the Changzhou plant, as well as the farms, workshops and middlemen that supplied it with the pig intestines that are crushed and then purified to make the main Heparin ingredient. Critics say the FDA and industry need to do a better job policing the quality of drugs throughout their overseas supply chains.
In addition to visiting the Changzhou facility, the FDA has spoken with some of its suppliers and has discussed probing the rest of the supply chain with Chinese authorities, agency officials said.
“We are not simply relying on information from our Chinese counterparts,” Silverman said. “We are engaged in an active investigation.”
As part of its inspection of the Changzhou plant, Baxter confirmed that the facility assured the integrity of its suppliers, said Deborah Spak, a company spokeswoman. Baxter has sought to visit the Changzhou plant’s suppliers, Spak said, “but we have not been able to get in there, and, quite honestly, that would be voluntary on their part. We are not their customer.”
VIA - [BaltimoreSun]