The Most Promising New Heart Devices
Posted by: drugsinus on: March 25, 2010
Movie legend Elizabeth Taylor, 78, took to the micro-blogging site Twitter last October and announced she was undergoing an experimental heart procedure.
“It’s very new and involves repairing my leaky valve using a clip device, without open heart surgery, so that my heart will function better,” she wrote. Heart device aficionados immediately recognized the device as the MitraClip, from Abbott Laboratories ( ABT – news – people ), which is not yet approved by the Food and Drug Administration. Taylor was apparently in one of several ongoing research studies. Two days after the surgery she twittered again: “It’s like having a brand new ticker.”
If approved, the device would enable surgeons to repair leaky heart valves without the need for full-blown open heart surgery. They could do it through two tiny keyholes instead. In a study presented at the recent meeting of the American College of Cardiology, the MitraClip didn’t seem as effective at preventing blood from leaking through the mitral valve that separates the top-left chamber of the heart from the bottom as the traditional method opening up the chest and doing surgery. But it does involve fewer complications. It may be an option for patients in whom open-heart surgery is deemed too risky.
Nine Promising Heart Disease Treatments
“We need to have more data, but I’m impressed with the early results,” says Sidney Smith, director of the Center for Cardiovascular Science and Medicine at the University of North Carolina. “As experience with the technology improves there’s the potential that a lot of patients who are not good candidates for surgery may well benefit from this.”
Deaths from cardiovascular disease have plummeted 30% over the past decade thanks to drugs to lower blood pressure and cholesterol and devices that help get patients through the danger period after a heart attack or sudden heart stoppage. But heart disease is still America’s top killer, claiming 630,000 lives annually. Experimental medicines are having trouble making a further dent on other common, costly, and dangerous problems like heart failure, heart valve disease and various heart rhythm problems. For some patients, new gadgets being developed by the medical device industry may have a big impact.
One of the biggest unsolved problems is heart failure, in which the heart’s muscle becomes too weak to pump blood. It affects nearly 6 million Americans. Fluid buildup fills the lungs, making patients feel they are drowning. Old drugs like beta blockers and diuretics (water pills) can help prevent the buildup and improve survival. But once patients get sick enough to end up in the hospital, they come back again and again. Almost all attempts at developing new drugs have failed. Treating heart failure costs Medicare $30 billion a year, making it one of the most expensive diseases for the government.
Last year, researchers proved that a new kind of medical implant could reduce heart failure hospitalizations 40%, according to the results of a 1,820-patient study. Hearts that are failing aren’t just weaker, they pump with the wrong rhythm. The cardiac resynchronization therapy (CRT) involves implanting a special type of pacemaker that uses electric charges to keep the heart’s chambers pumping in rhythm with each other. Arthur Moss of Rochester University, the electrophysiologist who ran the trial, notes that the device was “dramatically more effective” in women than in men–a good thing, since women are harder hit by heart failure.
In the wake of the study, a panel of advisors to the Food and Drug Administration recently recommended the CRTs be approved for as many as 4 million more patients.
CRT devices are made by Medtronic ( MDT – news – people ), St. Jude Medical ( STJ – news – people ) and Boston Scientific ( BSX – news – people ), which funded Moss’ study. In an ironic twist, all of Boston Scientific’s heart rhythm devices were recently temporarily taken off the market due to a regulatory snafu that could drag on for many weeks.
What You Need To Know About Fish Oil
Posted by: drugsinus on: March 10, 2010
Fifty years ago, two Danish epidemiologists pondered why Greenland’s native Inuit could have a very low rate of heart attacks despite eating a high-fat diet full of whale and seal meat. They cobbled together $6,000, flew to Greenland and collected blood samples from 130 Inuit.
The Greenlanders’ cholesterol numbers were good but not enough to explain the healthy hearts. Back in the lab the Danish researchers used an old gas chromatograph to study the samples, and found chemicals that they had never heard of before called omega-3 fatty acids. The chemicals, they argued, might explain the heart protective effect of the fish oil.
Today, omega-3 fatty acids have become a multibillion-dollar business. Americans spend $2.6 billion on nutritional supplements and foods fortified with omega-3 fatty acids. There’s even an expensive prescription version of fish oil.
In Pictures: 10 Things You Need To Know About Omega-3 Fatty Acids
But not all of this is money well spent.
Decades of research back up the claim that the types of omega-3s found in fish oil, called EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), protect the hearts of people who already have cardiovascular disease. Fish oil may also have benefits in healthier people at high risk of developing heart disease.
But many of the foods you find at the supermarket are supplemented instead with alpha-linoleic acid (ALA), the type of omega-3 found in nuts and flax seeds. Cardiologists believe it does not have the same benefits, because the body does a poor job at converting ALA to EPA. “There may be differences in effectiveness,” says James Stein, head of preventive cardiology at the University of Wisconsin Medical School. So if you are buying a supplement for the heart benefits, make sure it contains EPA or DHA and not ALA.
Omega-3 fatty acids, found in oily fish such as salmon, herring, sardines and trout now get plenty of press for all sorts of benefits beyond protecting against heart disease, including fostering brain and eye development in kids and helping ease depression. One study indicated they may spare young people with signs of mental illness from developing full-blown schizophrenia.
“We in the West are just not eating enough omega-3s,” says William Harris, a University of South Dakota nutritionist who is one of the leading experts on these fats. He notes two of three big clinical trials of fish oil show a reduction in deaths. “That’s what sets omega-3s apart” from numerous other hyped vitamin supplements.
Omega-3s’ benefits are mainly proven in heart disease, where big clinical trials have shown that lots of fish or doses of fish oil supplements can help people who already have heart disease. In patients with heart disease, trials have found that fish oil pills can modestly decrease a person’s chances of dying. The fats may act as a mild blood thinner, and may even reduce the risk of sudden cardiac arrest by improving the electrical conductivity of heart cells.
Saving Big Bucks On Prescription Drugs
Posted by: drugsinus on: March 5, 2010
When shopping for car insurance, airplane tickets or a flat-screen television, people make a point of getting price quotes first and carefully shopping around for the best value.
But shopping around is hardly the norm when it comes to prescription drugs. It is hard to find out the prices for drugs, let alone comparative information about which drugs work best, so people don’t bother. Many just assume, without asking, that whatever expensive drug their doctor prescribed for their mild condition must be the only option.
All this can be a big mistake. For prudent pill-poppers, there are possible ways to save big, if you are willing to do some research. In some cases, you may have to gently challenge your doctor–who probably has no clue just how much some of the prescriptions he is writing cost–to switch your medication to a cheaper alternative.
In Pictures: Eight Ways To Save On Prescription Drugs
Part of the problem is that each health plan covers prescriptions using a different formulary and cost-sharing scheme, so consumers often only see what the co-pay is. But this is changing as more people become uninsured or transition to cheaper, high-deductible plans where they must pay directly for drugs. According to a survey by the Center for Studying Health System Change, one in seven people under the age of 65 skip filling prescriptions each year because of the high cost. (See Forbes’ exclusive survey of The Most Expensive Prescription Drugs.)
The first step to savings is checking out various Web sites that attempt to rate and compare drugs on clinical effectiveness, similarities to others and even price. HealthGrades has a star system to show which drug in a class costs the most. WebMD ( HLTH – news – people ) has terrific information about side effects but offers its pricing data mostly to health plan members. Drugstore.com also can give you a rough idea of what most medicines cost.
One effective way to save money is to make sure you really need all the drugs you have been prescribed. In some cases, you may be able to treat your problem with lifestyle changes alone. Diet and exercise changes and weight loss can help with many conditions, including high cholesterol, high blood pressure and mildly elevated blood sugar. Arthritis and heartburn are also linked to obesity. (For more, see “Just Say No”) Obviously, consult your doctor first before you decide that you don’t need to take a drug.
Another example: Doctors frequently prescribe antibiotics for colds (always caused by viruses) and viral ear infections, sometimes because they feel subtle pressure from patients to prescribe something. But antibiotics don’t work against viruses.
If you are taking lots of medications prescribed by various different doctors who aren’t coordinating with each other, have a pharmacist carefully review the whole list to make sure that all of them are really necessary.
A medication review might show duplication or drugs that have bad interactions. Correcting the problem could lower your bill and prevent side effects.
The World’s Healthiest Diets
Posted by: drugsinus on: March 3, 2010
Is the American diet really so bad that it’s time to look to other countries for help?
That’s the premise behind a spate of recent books and Web sites touting plant-heavy diets of various far-away places. Looking at traditional diets has become something of a fad in recent years. Numerous books, including The Jungle Effect and The China Study, have tried to document the link between diet and great health in various countries and regions. Researchers, for example, are still trying to understand how a sweet-potato-based diet may boost longevity on the Japanese island of Okinawa, home to a large population of centenarians. But you don’t have to wait for the definitive answer–The Okinawa Diet Plan can be bought right now.
The latest entrant is The Five Factor World Diet by celebrity trainer and author Harley Pasternak. During his far-flung travels with stars like Jessica Simpson and Hillary Duff, Pasternak noticed that people in many of the countries he visited were slimmer and ate a more nutritious diet than most Americans. The experience left Pasternak (who has a master’s degree in exercise physiology and nutrition) convinced that Americans have a lot to learn from the rest of the world.
His book lists countries with healthy diets that also have long life expectancies and low obesity rates. These metrics best capture the effects of a lifetime of good eating and exercise habits, he argues. Japan tops his list because it has a 1.5% obesity rate (for men) and an 82-year life expectancy, vs. a 36.5% obesity rate and a 78-year life expectancy in the United States. South Korea, China and Singapore also do well. France makes the list with a 6.6% obesity rate and an 81-year life expectancy, as do Italy, Spain and Greece. Pasternak’s rankings aren’t scientifically rigorous, but they may shed light on how other countries eat well and manage to stay healthy.
In Pictures: The World’s Healthiest Diets
What virtually all these countries have in common are low-fat diets rich in fish, lean protein, vegetables, fruits and beans. Plant-based diets can reduce cholesterol levels, while fruits and vegetables also contain antioxidants that may protect against cancer. Consumption of certain omega-3 fatty acids found in fish may reduce heart disease risk. Many of the traditional diets only include small amounts of red and processed and salt-cured meats, whose consumption may increase risk of colorectal and stomach cancers.
Most of the countries in question practice portion control. Although they indulge in high-fat cheeses, cured pork and condensed milk coffee drinks, they rarely pig out like Americans. “Whether you adopt one or multiple things [from these countries] and bring them into your life,” says Pasternak, “you’ll be healthier and lose weight and keep it off.”
Beyond this common-sense message, science doesn’t have much to say about which traditional cuisines are the healthiest. It’s impossible to tell whether the long life expectancies of some countries are actually the result of better health care systems, not better eating habits. No researcher has developed a method to accurately measure the comparative health benefits of one country’s diet vs. another, says Harvard epidemiologist Dimitrios Trichopoulos. “We have no evidence because we don’t have a yardstick,” he says. There are indications that Japanese and Chinese diets, for example, are protective against chronic diseases and improve longevity, but Trichopoulos says that they haven’t been studied enough to say that conclusively.
The one exception, he says, is the Mediterranean diet, high in olive oil, fruits and vegetables, and whole grains. A 2008 meta-analysis of 12 studies of 1.6 million subjects found that people who stick closely to the Mediterranean diet had a 9% lower death rate than people who ate the same diet less stringently, according to the results published in the British Medical Journal. Numerous other studies show it can protect against heart disease.
A First: Diagnosis By DNA
Posted by: drugsinus on: February 23, 2010
Last year a five-month-old boy in Turkey stopped gaining weight and became dehydrated despite getting plenty of liquids. Specialists in Istanbul suspected Bartter’s syndrome, a potentially fatal kidney disorder that afflicts one in 100,000 babies, causing dangerously low levels of potassium and salt.
To confirm their hunch they sent a blood sample to Yale Medical School geneticist Richard Lifton. They asked him to determine whether the baby had the gene defect implicated in Bartter’s. But Lifton thought that Bartter’s might not be the culprit. So he did something that would have been prohibitively expensive a few years ago. He deciphered the DNA letters for all the baby’s genes. The gene scan revealed that the baby’s problem was not Bartter’s but something else called congenital chloride diarrhea, which also lowers salt levels. The result means that the baby, now doing better on a special diet, could be treated with drugs if his condition gets worse.
The case, published in the Proceedings of the National Academies of the Sciences in October, may be the first in which the results of DNA sequencing have altered treatment of a patient. Does this herald the beginning of a new kind of medicine in which patients with unexplained symptoms get their DNA sequenced? Yes, says Lifton: “This will be a court of last resort to try and identify causes of disease.”
Gene researchers have talked for years about how sequencing will transform medicine. Now that sequencing is cheap this transformation is under way. The cost of deciphering all 6 billion letters in the human genome has dropped from $1 million in 2007 to less than $20,000 today. Lifton used a two-step method to extract and sequence only the 1% of those letters that contain known genes, lowering the price to $2,500. New DNA sequencers just introduced by Illumina ( ILMN – news – people ) (whose model Lifton used) and Life Technologies ( LIFE – news – people ) could lower the cost of sequencing a whole genome to below $3,000 by year-end.
DNA sequencers haven’t been approved for use in medical testing, and insurers don’t pay for sequencing. But peering into DNA is becoming an option for wealthy patients with rare and scary diseases. Knome, a privately held company in Cambridge, Mass., started out in 2008 charging $350,000 to arrange sequencing and interpret the data for wealthy patrons as a vanity project. Now it offers the scans for as little as $25,000. Chief Executive Jorge Conde says several patients hoping to improve their care are among his customers.
The $600 million annual market for DNA sequencers is still all about research, with Illumina holding a 60% market share. But numerous companies are already jockeying for position in anticipation of a big future medical-test market.
Cancer patients may be among the first to benefit from DNA sequencing technology. In one early example of how this may work, Marco Marra, a researcher at the Michael Smith Genome Sciences Centre in Vancouver, last year sequenced the genes from a tumor that had spread from an 80-year-old patient’s tongue to his lungs. There is no standard therapy for this type of tumor. But the gene scan found the tumor was making large amounts of a growth-promoting protein called RET. When the patient’s medicine was switched to Pfizer‘s ( PFE – news – people ) Sutent, a drug that blocks this protein, the tumor shrank, according to a report in Nature.
A looming question is how the Food & Drug Administration will regulate sequencing technology. It could treat DNA sequencing like genetic tests and require separate approvals for each use. Some equipment makers hope for a faster path in which doctors practicing a new medical specialty emerge to evaluate and interpret gene scans, as radiologists do with X-rays. Clifford Reid, chief executive of Complete Genomics, which has finished 50 genomes, is skeptical that it will be that easy. “The FDA has been very quiet up until now,” he says. “We all have to expect the FDA to be intimately involved with these new tests.”
When City Hall Tells You What To Eat
Posted by: drugsinus on: February 10, 2010
Americans eat way too much. Our diets are laden with dangerous amounts of salt, empty calories from corn syrup and artery-clogging trans fats.
Now the politicians at City Hall want to do something about it. In an effort to curb obesity and improve heart health, city and state public health officials across the country are cracking down on fast food, sugary sodas, trans fats and other unhealthy ingredients. They are banning fast food in certain neighborhoods, demanding that restaurants post calorie counts, and considering taxes on sweetened soda.
Ever the trend-setter in this arena, New York City announced in January it was leading an initiative to lower salt levels in packaged and restaurant-prepared foods. The move, says health commissioner Dr. Thomas Farley, is based on evidence that most Americans consume too much salt, putting them at higher risk for heart attacks and strokes. Many packaged foods contain sky-high amounts of salt.
It sounds like good public policy. But critics bemoan the lack of evidence showing that this and other initiatives will improve public health and make unhealthy eaters change their ways. Some researchers say the new laws and initiatives represent uncontrolled experiments that could backfire and end up having as many negative consequences as positive ones.
No one has ever conducted large-scale clinical trials to measure the effects of reducing salt intake in the general population, for example. The same is true for bans on trans fats, and few studies have looked at the calorie labeling requirement at restaurants.
In an article published last week in the Journal of the American Medical Association, epidemiologist and Albert Einstein College of Medicine professor Michael H. Alderman argues that lowering salt content in the population may in fact be harmful. He points out that in some clinical trials, reductions in salt levels has led to decreased insulin sensitivity and increased production of a blood pressure-regulating hormone. Alderman has served as a scientific adviser to the pro-industry Salt Institute since 1996.
Farley stands by the city’s decision. While the evidence on salt reduction is not yet definitive, he says, most experts are convinced of the potential health benefits. He also says tackling high blood pressure by targeting consumer products is a necessary approach.
“The way that public health has been most successful is when we create environments that make it easy for people to live in a healthy way,” says Farley.
That’s been the thinking behind the city’s many public health interventions of late. In 2006, the city council voted to ban artery-clogging trans fats from restaurants. In 2008, it passed a law requiring chain restaurants to clearly post calorie counts on their menus. Last November, Farley and the state’s governor advocated for a tax on sodas to bring in close to a billion dollars annually and discourage consumption of the sugary beverage, which is associated with obesity. The idea hasn’t gotten legislative traction yet.
Ten Questions About High Cholesterol
Posted by: drugsinus on: February 4, 2010
Twenty million Americans take cholesterol-lowering drugs. So you might think that scientists have high cholesterol pretty much worked out.
But you’d be wrong. This oily molecule, which lines our cell membranes and provides raw material for our hormones, continues to mystify top scientists.
Here’s what we know for sure: Too much cholesterol is bad for you and drugs to lower it can help. While the body needs cholesterol to survive, most adults have far too much of it. That translates into an increased risk of heart attacks, because cholesterol collects as plaque in the arteries. These can become inflamed and deposits can suddenly break off, causing heart attack and stroke.
Statins, the class of cholesterol drugs that includes simvastatin (generic Zocor), Lipitor and Crestor, have been proved to prevent heart attacks and strokes in numerous studies involving 90,000 patients. Exercise and weight loss can also help lower bad cholesterol levels and heart risk. Eating large amounts of certain foods–such as oats and salmon–may also help.
“We know an awful lot,” says Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “If you look at what’s happened to cardiovascular rates in the past couple of decades, we certainly know enough to know one class of drugs, statins, has had a very big impact. If you give these drugs to susceptible individuals, you can reduce their risk by 25%. The problem is we are kind of stuck in a rut. We haven’t had a new class of drugs since 1987 that has had proven benefits. That’s not a very good track record, so obviously there’s still a lot we don’t know.”
One unresolved question is whether all methods of lowering cholesterol are created equal. Most of the cholesterol in the body is made from fat in the liver. Statins work by short-circuiting this process. They may also cut levels of inflammation. But the cholesterol drug Zetia, from Merck ( MRK – news – people ), works by a totally different mechanism, one that has not been proven to prevent heart attacks. It works by blocking absorption of cholesterol from food. In two trials, the drug failed to prevent clogged arteries. Merck is only now conducting a big trial to see if it prevents heart attacks.
A related controversy, brought up in an analysis in the Annals of Internal Medicine last month, is whether doctors are using statins the right way. Doctors currently use drugs to try to get patients’ LDL down to a specific target–for most people the target is 120 milligrams per deciliter. But Yale cardiologist Harlan Krumholz and University of Michigan internist Rodney Hayward say this is unnecessarily complicated. Instead, they recommend doctors estimate people’s total cardiovascular risk using a multiple risk factors like high blood pressure and age (check your risk here). People with a 15% or higher 10-year risk of suffering a heart attack should get a healthy dose of Lipitor (40 mg); everyone else should take generic simvastin, also at a 40 mg dose. Krumholz and Hayward calculate this method would prevent more heart attacks than bothering with numerical targets, while allowing patients to take lower doses of drugs.
Another debate is whether it is worth it to take drugs that lower blood levels of fatty particles called triglycerides. Some doctors are big believers in lowering triglycerides, which has made Abbott Laboratories’ ( ABT – news – people ) TriCor drug a $1 billion product. But the drug has not really proven its heart-protecting benefit in a big trial. One is due next month at the annual meeting of the American College of Cardiology. Fish oil supplements containing certain omega-3 fatty acids can lower triglyceride levels and may protect the heart in other ways as well.
One more big question is whether drugs that raise good cholesterol (HDL) can benefit people. People with naturally high levels of HDL are somewhat protected against heart disease, but most attempts to raise HDL with drugs have flopped. One HDL-raising drug out there is the B-vitamin niacin, also sold by Abbott under the brand name Niaspan. Major trials of its effectiveness are due in the next couple of years.
New research into the human genetic code is yielding new questions about how the body regulates cholesterol levels and clues to new potential drugs. One apparently supercharged version of HDL is in clinical trials already. Another promising lead is a gene called PCSK9. People with certain variants of this gene seem to be protected from developing high cholesterol and heart disease.
In medicine, absolute certainty is always elusive. Even after tens of thousands of patients have been followed for years in clinical trials, some worry there are side effects of statins that still haven’t turned up. But a link to cancer has been disproved, and cardiologists insist these are some of the safest medicines around. Some researchers speculate they might have benefits in diseases like Alzheimer’s or in preventing tumors, but again, this evidence is murky.
The bottom line: Cardiologists don’t know much as much as you might think about high cholesterol. But they do know that you should watch your diet and exercise. If you are still at risk of a heart attack, consider taking a statin drug like Lipitor or generic Zocor.
Ten Misleading Drug Ads
Posted by: drugsinus on: February 3, 2010
When drug maker Allergan came out with the new eyelash thickening drug Latisse last year, it put on a marketing blitz featuring actress Brooke Shields. The Latisse Web site showed her longer, thicker lashes from the drug.
But the site barely mentioned Latisse’s nasty side effects, which can include hair growth outside of the treatment area, a permanent darkening of eye color and bacterial infections that can lead to blindness.
The Food and Drug Administration lashed out in September 2009. In an official warning letter the FDA scolded Allergan ( AGN – news – people ) for its “misleading” claims about Latisse, which it said “omit and minimize” the drug’s side effects. It demanded the company fix the Web site immediately.
The FDA’s decision to confront Allergan is part of a renewed effort by the agency to crack down on questionable marketing claims under President Obama. The agency’s unit that regulates advertising sent 41 enforcement letters in 2009, twice the number sent in 2008.
In addition to Latisse, the FDA went after Eli Lilly ( LLY – news – people ) for a print ad misrepresenting its depression and pain drug Cymbalta; Abbott Laboratories ( ABT – news – people ) for an upbeat DVD interview in which Earvin “Magic” Johnson suggests the HIV drug Kaletra is more effective than studies show; and GlaxoSmithKline ( GSK – news – people ) for online ads marketing its migraine medication Treximet without sufficiently mentioning rare but potentially life-threatening side effects.
Of course, stretched-thin or downright misleading drug marketing claims are nothing new. For most of the 1990s drugs were rarely advertised on television because regulators required that all ads list detailed information about every possible side effect. But in 1997, the FDA issued new rules for direct-to-consumer advertising, opening the floodgates for drug companies to advertise on television. Spending on drug ads aimed at consumers soared. By 2000 it had risen to $2.2. billion a year from just $844 million in 1997.
“Since at least 2000, the manufacturers have consistently tried to push the envelope with excessively rosy messages about benefits and less-than-robust descriptions of risks,” says Harvard Medical School internist Jerome Avorn, author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. During the Bush administration, he adds, “FDA leadership made it clear they were not going to be zealous in keeping the industry’s feet to the fire on such ads.”
By 2006 the number of FDA warning letters about dubious marketing claims had plummeted to 21 from 142 in 1997. Some very dubious ads were produced along the way. Lipitor ads featured artificial heart inventor Dr. Robert Jarvik endorsing the popular cholesterol drug. Some appeared to show him rowing across a lake. Pfizer ( PFE – news – people ) stopped running the ads in 2008 only after congressional investigators revealed that Dr. Jarvik was not licensed to practice medicine. It also turned out that Pfizer used a body double to do the rowing scenes.
These days the FDA is being much more aggressive in going after companies that try to bury side effect information in miniscule print. Last year GlaxoSmithKline put out online banner ads for its migraine medication Treximet featuring a migraine sufferer holding her head in her hands. The picture caption read, “I just want to take my head off.” She was smiling happily in the next photo–after taking Treximet.
The FDA complained that GSK didn’t do enough to highlight the serious risks of taking Treximet, which appeared in quickly scrolling text at the bottom of the banner. These include heart attack, stroke and gastrointestinal bleeding.
Sometimes companies egregiously exaggerate how well their drugs work. In a brochure given to doctors and nurses last year, the Japanese drug company Eisai claimed that its Dacogen drug helped 38% of patients with a rare blood cell disorder in a clinical study. This figure was false, the FDA said in a November 2009 warning letter. In fact, the figure was taken from a tiny subgroup of patients who responded well to the drug. When all patients in the study were included, the real response rate was a much less impressive 20%, the FDA noted.
“It’s almost impossible for the public to actually parse the ads and come to their own independent conclusions,” says Cleveland Clinic cardiologist Steven Nissen, a fierce critic of drug ads.
But Nissen is suspicious of most drugs that are advertised because he thinks that the marketing campaigns distract and mislead consumers. His advice: avoid the most heavily advertised drugs and stick to generics.
How can you avoid getting misled by drug ads? One way is to skip over the glowing patient testimonials and seek hard data about the medication’s risks and how it performed in clinical trials. Every drug Web site also includes a link to the drug’s official FDA label (the link usually says something like “Full Prescribing Information.”) It’s heavy reading, and many doctors don’t even bother to do it. But it will have definitive, unvarnished information on how effective the drug was in its clinical trials and exactly what all the side effects were.
America’s Least Deadly Hospitals
Posted by: drugsinus on: January 27, 2010
When contemplating major surgery, many people go to whatever hospital their family doctor recommends. Others chose a hospital for its star surgeon or because they’ve seen billboard ads touting its specialties.
Either way, it can be a fatal mistake.
Every year 100,000 people die in hospitals because of preventable complications or hospital-acquired infections. Many more suffer serious harm as a result of well-intended treatments gone awry.
Modern care has become so complex that there are lots of things that can go wrong. Teamwork, checklists and attention to detail are crucial at preventing bad outcomes. Having a skilled cancer surgeon won’t help you if you get a nasty post-surgical infection–and the staff at the hospital doesn’t catch it in time.
HealthGrades, a hospital rating company based in Golden, Colo., has singled out 269 hospitals across the country with unusually low mortality and complication rates for 26 different procedures and diagnoses. These include treatment for heart failure, pneumonia, stroke, as well as hip and knee replacement operations, back surgery and stent procedures. The hospitals represent the top 5% in the country at preventing mortality and complications.
The hospitals have a 29% lower mortality rate and 9% lower complication rate compared with all other hospitals. The rankings are based on data from 40 million patients on Medicare who were hospitalized between 2006 and 2008.
HealthGrades estimates that if every hospital performed as well as those in the top 5%, it could potentially save 150,132 lives and prevent 13,104 complications in the Medicare population. “There’s huge variation in quality,” says Dr. Rick May, vice president of clinical consulting for HealthGrades. “Patients need to be careful about evaluating their health care providers before handing over their lives and health.”
The most surprising part of the list is how many big-name academic hospitals are not on it. Johns Hopkins Hospital and various hospitals affiliated with the University of Pennsylvania weren’t good enough to qualify. Harvard’s Massachusetts General Hospital and Cedars-Sinai Medical Center in Los Angeles were on the list last year but didn’t make the cut this year.
May says that prestigious academic centers tend to build a reputation on cutting-edge research and excelling at the unusual, like solving rare cases and treating exotic diseases. They may not always excel at less glamorous basic procedures and treatments, he argues.
Regional hospitals were heavily represented in the study, and many of them were part of a larger chain. These included Methodist Hospital in San Antonio, Texas, Good Samaritan Hospital in Dayton, Ohio, and Christiana Hospital in Newark, Del. One advantage of having sister hospitals, says May, is that they can compare data and strive to emulate each other when the outcomes are good.
Jan Hess, vice president of St. Luke’s Hospital in Chesterfield, Mo., says its work on preventing post-operative infections landed it on HealthGrades’ list for the eighth consecutive year. When the hospital realized one patient per month was contracting ventilator-associated pneumonia, it worked on strategies to eliminate the problem. Among other tactics, the hospital staff began elevating beds at least 45 degrees and suctioning patients frequently to avoid fluid build-up. There have been no cases of ventilator pneumonia since November 2006.
The Reading Hospital and Medical Center in West Reading, Pa., has almost halved the average time that heart attack patients have to wait between when they arrive and when a catheter is inserted to open up a blocked artery. National guidelines recommend a standard of 90 minutes, but at Reading the median time in 2009 was 54 minutes. That efficiency can save heart muscle. “We really don’t have any magic solutions,” says Debra Levengood, assistant vice president of quality management at Reading. “It’s a constant effort.” The hospital, which specializes in cardiac and stroke care, has also taken other steps such transmitting electrocardiograms before a patient arrives in the emergency room so that doctors can quickly devise a treatment plan.
Thirty-six states had at least one hospital on the HealthGrades list. Chicago had seven hospitals on the list, including Northwestern Memorial Hospital and Rush University Medical Center. Baltimore had five. Pennsylvania had 15 in places like Scranton, Pittsburgh and Erie.
Dr. Jerod Loeb, executive vice president at the hospital accrediting organization Joint Commission, says that composite rankings like the HealthGrades score should only be used as a starting point. A hospital could be good on average but do a bad job at the particular type of surgery you need.
In addition to its composite rankings, HealthGrades offers consumers free access to its online database so they can see whether or not a hospital exceeded or beat predicted mortality and complication rates for particular procedures. The Centers for Medicare and Medicaid Services also ranks hospital performance on its Web site Hospital Quality Compare.
Above all, says Loeb, patients should seek information from multiple sources. “It is increasingly clear there is no one single metric that one should use when choosing a health care provider,” he says.
.methodBox { background-color:#d6e8ed; padding:2px 10px; border:1px solid #666; } .methodBox p { font-size:12px !important; line-height:16px !important; } Methodology Box
HealthGrades uses approximately 40 million Medicare inpatient records for hospitalizations between 2006 and 2008 to develop its rankings. It looks at 26 procedures and diagnoses and adjusts for significant differences in the data, including demographic and clinical risk factors. It compares performance among hospitals and assigns them one of three star ratings for each of the procedures and diagnoses measured: 1-star (poor), 3-star (as expected) or 5-star (best). To be eligible to receive a star rating, a hospital must have a minimum of 30 cases over the three years of study and at least five cases in the most recent year analyzed.
Big Pharma’s Best Chief Steps Down
Posted by: drugsinus on: January 26, 2010
Novartis Chief Executive Daniel Vasella likes to shake his company up every few years. Now he’s reshuffling himself.
Vasella, just 56 years old, stunned investors on Tuesday by saying he was stepping down as chief executive effective Feb. 1 and appointing pharmaceuticals head Joseph Jimenez in his place. Vasella will remain chairman, a full-time job focusing on strategy.
In another surprise, cancer drug unit head David Epstein will replace Jimenez as head of pharmaceuticals. Chief Operating Officer Joerg Reinhardt, long viewed as an heir apparent, is leaving the company.
Jimenez, 50, has big shoes to fill. Vasella is viewed as one of the most savvy strategists in the drug industry. Among other problems, Jimenez will have to deal with the patent expiration of Novartis’ ( NVS – news – people ) bestselling blood pressure drug, Diovan, in 2012.
Early in his tenure Vasella combined two struggling Swiss drug companies (Ciba-Geigy and Sandoz) and turned them into an international drug powerhouse; it is one of the few major drug company mergers that has gone relatively smoothly. One of the few medical doctors to lead a big drug company, Vasella saw potential in a new leukemia drug called Gleevec when others were skeptical. It is now Novartis’ second- biggest-selling drug. More recently, as the market for mass-market pills has gone south, Vasella used acquisitions to diversify into vaccines and generic drugs. Other companies have since made similar moves.
In an interview Vasella said he first approached the board last June about succession plans. The board members considered several options–including having Vasella retire outright–but quickly decided he should stay on in a more limited chairman capacity while a new chief executive ran day-to-day operations.
By the fall, after considering numerous internal and external candidates, the board settled on two: Jimenez and Reinhardt, Vasella’s long-time right-hand man. But Vasella didn’t tell either of the candidates what was going on until very recently. “I was not informing anyone what my plans were. You need to make transition periods very short, otherwise you have a lot of collateral damage,” he explains. Vasella told Jimenez he was probably the choice around Christmas, and the decision was not finalized until Monday.
Vasella says Jimenez got the job because he has an unusual ability to inspire the troops and give them a clear sense of direction. “Joe is able to set clear objectives and mobilize the people” without making them feel they are being ordered around, Vasella says. “He has composure under pressure, he doesn’t lose his temper and he has a sense of humor.”
Jimenez, a graduate of Stanford University, joined Novartis in April 2007 and ran the company’s consumer health division before moving the pharmaceuticals side. Before that he was head of H.J. Heinz‘s ( HNZ – news – people ) operations in Europe.
The hardest part for Vasella was telling his long-time lieutenant Reinhardt a week ago that he would not be getting the top job. “It was very tough for me,” he says. The two have worked together since 1992. Vasella says he offered him another job, but Reinhardt chose to leave instead.
The timing of the decision was dictated in part by Novartis’ recent decision to try to acquire the rest of eye care company Alcon ( ACL – news – people ) that it does not already own. Completing the massive deal and integrating the companies could take a couple of years. “If I did not signal clearly I was willing to make space” for others at the top, Jimenez might have left for another job, Vasella says.
