Over-the-counter Drug Label Alarms Get Overlooked, Study Says
Participants spent the most time focused on the brand names and product claims of nonprescription drugs. More than half of those surveyed also missed alerts about child safety on medicines that did not have child-resistant packaging, according to the research today in the Proceedings of the National Academy of Sciences.
The findings raise doubts about whether the warnings meet U.S. Food and Drug Administration requirements that they be “prominent” and “conspicuous,” the researchers said. Future studies need to look at whether changing package designs may help peoples eyes move more quickly to the notices or convey the information faster, said lead author Laura Bix.
“Something is going on with conspicuousness and prominence,” said Bix, an assistant professor in the School of Packaging at Michigan State University in East Lansing, Michigan, in a March 27 telephone interview. “Its definitely a chance to step back and look at the design of these labels and look at potentially educating consumers on the importance of the information.”
Following the Eyes
Researchers asked 61 participants to wear eye tracker devices to determine how long they looked at five areas of an over-the-counter products package. The areas were the tamper- evident notice, the child-safety warning, statements about whether the product was “extra strength” or “aspirin free,” the brand name and the drug facts box, which is similar to nutrition information on food packaging.
The participants had 10 seconds to look at each of 10 packages, five of which were over-the-counter medicines, which are drugs sold without a prescription. The other products were dummy packages, including batteries and laundry soap. Those in the study werent told of the trials emphasis on over-the- counter drug alerts. Participants also were interviewed about their recollections of what they had seen.
The researchers found that 80.3 percent to 96.7 percent of people in the study failed to look at the tamper-evident warning area on the label, depending on the product, while 47.5 percent to 57.4 percent didnt look at the child-safety warning area.
At least three-quarters of the participants noticed the brand name on all the medicines.
Safety Not Clear
“The general conclusion is important information about safety is not clear and is not organized in a fashion that people can focus on like they need to in order to make a rational purchasing decision,” said Sidney Wolfe, director of health-care research at the Washington-based consumer group Public Citizen, in a March 27 telephone interview.
Tamper-evident alerts were added to over-the-counter drug labels after seven people died in 1982 because they ingested cyanide-laced Tylenol, the researchers said.
Sales of over-the-counter medicines in 2007, excluding those from Wal-Mart Stores Inc., were $16.1 billion, according to the Web site of the Consumer Healthcare Products Association, a Washington-based trade group representing makers of nonprescription drugs.
Highly Regulated
“Medicine packaging and medicine Drug Facts labels are highly regulated,” said Barbara Kochanowski, vice president of regulatory affairs for the association, in an e-mail. “All OTC medicines must follow these regulations, which are designed to assure consumers can read and use the label.
“It may well be that the consumers in the review were already familiar with the labels and product features based on use on previous occasions,” she said.
The researchers noted the studys limitations included the narrow demographics of the participants, most of whom were college students without children, and the failure to collect information about their previous knowledge of the products. The study was sponsored in part by the Center for Food and Pharmaceutical Packaging Research at Michigan State.
Fish Oil Doesnt Help Heart Attack Patients In Biggest Study
The report, presented today at the American College of Cardiology in Orlando, Florida, contradicts previous smaller studies that suggested a daily supplement may help ward off repeat heart attacks, strokes and death. After taking a gram of purified fatty-acid supplements each day for a year, patients in the latest research, the biggest of its kind, fared no better than those who were given olive oil.
The 3,827 patients studied also got the best recommended therapy for heart-attacks, the researchers said. Most of the earlier studies were performed when heart-attack treatments were less advanced, they said. New treatments for heart attacks are so effective, they may have overwhelmed benefits from the fatty acids, the scientists said.
“We saw no beneficial effect,” said Jochen Senges, professor of cardiology at Heart Center Ludwigshafen at the University of Heidelberg, Germany, in a statement. “In patients who are already taking optimal medical therapy, cardiac event rates become very low and omega-3 do not further improve them.”
In 2004, the U.S. Food and Drug Administration granted the supplements a “qualified health claim status” for preventing heart disease, allowing companies to advertise the benefits of the supplements based on evidence. An August study of fish oil to treat heart failure, a condition in which the heart cant pump enough blood to supply oxygen to other organs, found the pills reduced deaths by 9 percent.
Community Health Centers
The latest research was conducted in 104 community health centers in Germany. Researchers found that over the course of the average yearlong follow-up, 3.9 percent of patients had another nonfatal heart attack, 1.7 percent had a nonfatal stroke, and 4.1 percent died. There were no significant differences between the group that took omega-3 fatty acids and the one that took the dummy pills.
Recommended care for heart attack patients varies by patient and includes a combination of tests, procedures and medicines.
About 94 percent of patients in the study had an X-ray exam of the heart called an angiography and 78 percent had angioplasty procedures. About 94 percent were prescribed drugs known as beta-blockers, 94 percent received cholesterol drugs called statins, 95 percent received aspirin and 88 percent received Plavix, a blood thinner made by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.
Fda Says to Avoid Pistachios Amid Salmonella Scare
Still reeling from the national salmonella outbreak in peanuts, the Food and Drug Administration said central California-based Setton Pistachio of Terra Bella Inc., the nations second-largest pistachio processor, was voluntarily recalling a portion of the roasted nuts it has been shipping since last fall. A Setton spokeswoman said that amounts to more than 2 million pounds of nuts.
“Our advice to consumers is that they avoid eating pistachio products, and that they hold onto those products,” said Dr. David Acheson, assistant commissioner for food safety. “The number of products that are going to be recalled over the coming days will grow, simply because these pistachio nuts have then been repackaged into consumer-level containers.”
Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasnt been confirmed, Acheson said. Still, the plant decided to shut down late last week, officials said.
The recalled nuts represent a small fraction of the 55 million pounds of pistachios that the companys plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.
California alone is the second-largest producer of pistachios in the world.
According to the companys Web site, Setton Pistachio is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. The company sells nuts, dried fruit, edible seeds, chocolate and yogurt-coated candies.
The FDA learned about the problem last Tuesday, when Kraft Foods Inc. notified the agency that it had detected salmonella in roasted pistachios through routine product testing. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.
The FDA contacted Setton Pistachio and California health officials shortly afterward, in what Acheson called a “proactive move.”
By Friday, grocery operator Kroger Co. recalled one of its lines of bagged pistachios because of possible salmonella contamination, saying the California plant also supplied its nuts. Those nuts were sold in 31 states.
Fabia DArienzo, a spokeswoman for Tulare County-based Setton Pistachio, said the company was only recalling certain bulk roasted in-shell and roasted shelled pistachios that were shipped on or after September 1.
Because Setton Pistachio shipped tote bags of nuts weighing up to 2,000 pounds to 36 wholesalers across the country, it will take weeks to figure out how many products could be affected, said Jeff Farrar, chief of the Food and Drug Branch of the California Department of Public Health.
“It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes,” Farrar said. “The firm is already turning around trucks in transit to bring those back to the facility.”
For nuts, roasting is supposed to kill the bacteria. But problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.
Last winter, a national salmonella outbreak was blamed on a Georgia company under federal investigation for flouting safety procedures and knowingly shipping contaminated peanuts.
The outbreak is still ongoing. More than 690 people in 46 states have gotten sick. Nearly 3,900 products made with peanut ingredients from Peanut Corp of America have been recalled.
California public health authorities have taken hundreds of samples at Settons processing facility, but lab results have not yet determined whether salmonella was found at the plant, Farrar said. The food companies own tests of the contaminated products isolated four different types of salmonella, but none were the same strain as the one found in the peanuts, Acheson said.
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Once-a-day Heart Combo Pill Shows Guarantee In Study
The experimental combo pill was as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a persons risk of heart disease and stroke roughly in half, the study concludes.
The approach needs far more testing - as well as approval from the Food and Drug Administration, something that could take years - but it could make heart disease prevention much more common and more effective, doctors say.
“Widely applied, this could have profound implications,” said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke Universitys heart research institute. “President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that.”
The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.
“If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden” and respond by skipping doses, he said.
No price for the polypill has been disclosed, but its generic components cost only a total of $17 a month now and doctors expect the combo would sell for far less.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. Johns Medical College in Bangalore, India. The findings were presented Monday at the cardiology colleges conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the “water pill” thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Doctors have talked about such a possibility for years. As the patents on many heart medicines expired and the drugs became available as cheap generics, a few companies started trying to develop all-in-one pills.
Formulating a single pill of five drugs that work in five different ways is a complex task - more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended.
The Polycap is the furthest along, and this is the largest study of one so far.
The study involved about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease - high blood pressure, high cholesterol, obesity, diabetes or smoking.
Compared to groups given no blood pressure medicines, those who got the polypill lowered their systolic blood pressure (the top number) by more than 7 units and their diastolic (the bottom number) by about 6 - comparable to levels for people who were given the three drugs without aspirin and the cholesterol drug.
These drops were modest, probably because doses were low and most participants had only moderately high blood pressure to start with, Yusuf said.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same with the polypill as with aspirin alone.
Side effect rates were the same for the polypill as for the five medicines individually.
Fish Oil Pills Dont Growth Benefit Of Heart Drugs
The study tested a 1-gram daily dose of a prescription version of highly purified omega-3 fatty acid - the “good fat” contained in certain oily fish that is thought to help the heart.
Researchers led by Dr. Jochen Senges of the University of Heidelberg gave fish oil or dummy capsules to more than 3,800 people who had suffered a heart attack in the previous two weeks. About 90 percent were already receiving all the medicines recommended to prevent a second attack, including aspirin, anti-clotting and cholesterol drugs.
After a year, it made no difference whether these patients took fish oil or dummy capsules. In both groups, fewer than 2 percent had suffered sudden cardiac death, 4 percent had another heart attack, and fewer than 2 percent had suffered a stroke.
If recent heart attack patients are already getting good care, “there is almost nothing you can do better on top of this” to further lower risk, Senges said. He presented the results Monday at an American College of Cardiology conference.
The research doesnt mean that fish oil is of no value, and the study didnt address whether it can help prevent heart disease in the first place, doctors said.
The prescription version used in the study, sold as Omacor and Lovaza in the United States and as Zodin in Europe, is a highly purified and standardized form, different from what many consumers buy off the shelf.
Omega-3 fatty acids also are found in wild oily fish such as salmon, tuna, mackerel, sardines and herring. Scientists think it raises HDL, or good cholesterol, lowers harmful fats called triglycerides and slows the growth of plaque that can clog arteries.
The American Heart Association recommends adults eat fish at least twice a week, said Alice Lichtenstein, a Tufts University nutrition professor and Heart Association spokeswoman. For people with heart disease, the association advises 1 gram of omega-3 a day.
“A modest, 3-ounce cooked salmon has a little more than a gram,” she said.
Fish oil capsules are not for children or women who are pregnant or nursing, because the pills pose a bleeding risk. Taking more than 3 grams a day from supplements should only be done under a doctors orders, the heart association warns. The capsules also should be stopped a week or so before surgery because of a risk of bleeding.
The German study shows that “we need to be a little more cautious about the prediction of individual benefit of any nutritional supplements,” said Lichtenstein, who had no role in the research.
“We see this pattern - people are so willing to embrace the simple answer,” as if its possible “to crack a capsule over a hot fudge sundae” and undo the harm of harmful diets and lack of exercise, she said.
On the Net:
Cardiology meeting: http://www.acc.org
Heart Association advice: http://tinyurl.com/25×6z
Ama Seeks Inquiry Of Journal Editors Actions
Editors of the Journal of the American Medical Association deny threatening a professor who raised concerns about a study authors undisclosed financial link to a drug company when JAMA published the study last year. JAMA, like most leading medical journals, has a policy of noting scientists industry connections.
According to the Wall Street Journal, JAMA editors threatened to ban the professor from their journal and ruin his medical schools reputation if he didnt stop talking to reporters.
The editors deny that. But the flap prompted them to spell out what amounts to a gag order on anyone who alerts the medical journal about suspicions that a researcher has undisclosed industry ties. The journal editors argue that any suspicions should be kept secret until JAMA can complete its own probe. That is an existing policy, JAMAs editor-in-chief, Dr. Catherine DeAngelis, told The Associated Press on Monday.
AMA journals are independent and the medical association doesnt interfere with what they publish. But AMA said Friday it has asked an independent oversight committee to investigate how JAMA editors handled the issue.
“As owner and publisher of JAMA, we take these concerns very seriously,” AMA board chairman Dr. Joseph Heyman said in a written statement.
The issue involves a study published in JAMA last May that said the drug Lexapro prevents depression in stroke patients. A Tennessee university professor who reads JAMA told the editors in October that he had learned that a study author had served as a speaker for Lexapros maker. Though other industry ties were noted in the journal, that one was not.
JAMA editors vowed to investigate.
The professor, Jonathan Leo of Lincoln Memorial University, also discussed his concerns in a March 5 letter posted on a different medical journals Web site.
On March 11, JAMA editors published a correction revealing the undisclosed ties to Lexapros maker.
JAMAs editors acknowledged in a March 20 editorial being upset about Leo airing his concerns. They argue that publicizing unconfirmed allegations about study authors could unfairly damage reputations and interfere with JAMAs own investigations.
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On the Net:
JAMA: http://jama.ama-assn.org
Fda Approves New Drug For Deadly Kidney Cancer
The Food and Drug Administration approved the pill on Monday to treat renal cell cancer, the most common form of kidney cancer.
The agency said patients tested with Novartis Afinitor lived more than twice as long without tumor growth as those who didnt receive the drug. The study by the Swiss drugmaker showed Afinitor delayed tumor growth nearly 5 months, compared with less than two months for patients not taking the drug.
Afinitor works by blocking a protein that helps cancer cells divide and grow. The drug was approved for patients who have already taken Pfizer Inc.s Sutent and Bayers Nexavar.
Kidney cancer is resistant to chemotherapy and radiation therapy, and the most effective remedy is usually to surgically remove the kidney. When the cancer is isolated to the kidney, a majority of patients will survive at least five years. If the cancer has spread to other parts of the body, the survival rate is much shorter.
About 13,000 patients died from the disease last year, according to the American Cancer Society.
Basel, Switzerland-based Novartis has submitted the drug for approval in the European Union, Japan and elsewhere.
Shares of Novartis fell 47 cents to close at $36.55 Monday.
Fda: Bristol-myers Diabetes Drug Appears Safe
Despite low rates of heart attacks and related problems in testing, the Food and Drug Administration will still ask an outside panel to scrutinize the companys safety data at a meeting Wednesday.
Bristol-Myers and partner AstraZeneca have asked the FDA to approve Onglyza to reduce blood sugar levels in patients with type 2 diabetes. The drug uses a chemical reaction similar to Mercks Januvia and would compete against the blockbuster medication, which had sales of $1.4 billion last year.
The drug is part of a new wave of medications taking aim at the U.S. diabetes market, which has grown to more than $5 billion as the disease becomes more prevalent.
Analyst estimates of Onglyzas market potential vary, given its similarity to a more established drug. Sales estimates range from $300 million per year to more than $1 billion.
Shares of New York-based Bristol-Myers climbed 36 cents, or 1.7 percent, to close at $21.02 Monday. U.S.-traded shares of London-based AstraZeneca rose $1.87, or 5.8 percent, to $34.25.
Regulators have begun demanding more rigorous safety testing of diabetes drugs since a 2007 analysis suggested GlaxoSmithKlines blockbuster pill Avandia could increase heart risks.
Under guidelines issued last year, FDA requires companies to test diabetes drugs on more high-risk patients, including the elderly, to detect potential heart problems. Detecting heart risks connected with diabetes drugs is challenging because patients with the disease are already at risk of heart problems.
Because Bristol-Myers and AstraZeneca conducted their studies before the guidelines were released, their testing “was not designed to prospectively measure cardiovascular risk,” agency reviewers noted. As a result the FDA said there is “insufficient information” to determine if some heart problems were related to the drug, according to briefing documents posted online.
At the agencys request, the companies went back after the fact and tried to analyze reports of heart problems with the drug. Based on that assessment, the level of heart attacks, deaths and other cardiovascular problems appeared well within the new safety limits imposed by the FDA.
The agency will ask its panel of experts on Wednesday whether the companys results are strong enough to make a follow-up safety study unnecessary.
A decision on whether to approve the drug is expected by the end of April. The FDA is not required to follow its panels advice, though it usually does.
Bristol-Myers and British firm AstraZeneca are just two of the drugmakers looking to capitalize on the U.S. epidemic of Type 2 diabetes, which affects some 23 million adults and teenagers.
Onglyza, known generically as saxagliptin, belongs to the DPP-4 inhibitor family of the diabetes medications, which also includes Mercks drug Januvia.
The drugs work by blocking the DPP-4 enzyme, which spurs release of insulin-boosting proteins that help control blood sugar levels.
On Thursday FDAs panel will review another proposed diabetes treatment from Novo Nordisk. The Danish drugmakerss liraglutide boosts insulin while restricting the hormone GLP-1 hormone, which drives up blood sugar.
If approved, the once-daily injection would compete with Eli Lilly and Amylin Pharmaceuticals Byetta, a twice-daily injectable drug in the same family of medications. The makers of Byetta are working on their own extended-release version of the drug that would only require one injection per week.
Boston Scientific Stents Less Effective Than Others In Studies
Taxus Liberte, Boston Scientifics newest stent, required more repeat procedures than products from Medtronic and J&J in a South Korean study reported yesterday at the American College of Cardiology meeting in Orlando, Florida. In a separate trial, two Taxus models were linked with an 88 percent higher risk of heart-related deaths than Abbotts market-leading Xience stent.
Stent makers are competing for a $4 billion market. In January, seven months after its U.S. debut, Xience had grabbed 28 percent of the market, Boston Scientific said in a call with investors. Taxus, with 24 percent, was third behind the 25 percent recorded for a Xience copy, called Promus, that is licensed from Abbott and sold by Boston Scientific.
Market leadership is “just a credit to Bostons sales and marketing prowess,” said Tim Fischell, the director of cardiovascular research at Borgess Research Institute in Kalamazoo, in an e-mail. Given the stents showing in past trials, “its amazing that Taxus is used over J&Js Cypher,” which has just 14 percent of the market.
Boston Scientific, based in Natick, Massachusetts, last year introduced both Taxus Liberte, an updated version of the companys existing drug-coated stent, and Promus, the Xience copy it licenses from Abbott Park, Illinois-based Abbott. Stents are tiny mesh devices that keep arteries from closing down after theyve been cleared with angioplasty.
Unlikely to Change
The results for Xience and Cypher, made by New Brunswick, New Jersey-based J&J, are unlikely to change market share, said Sidney Smith, a University of North Carolina cardiologist, in a telephone interview. Xience, introduced in July, is already the top-selling stent. Also, some doctors were skeptical about Cyphers surprisingly low rate of triggering blood clots in the South Korean trial, called Zest, Smith said.
With all four companys stents performing relatively equally in past studies, the battle may come down to price, said Smith, director of the schools Center for Cardiovascular Science and Medicine.
Drug-coated stents sell for $2,000 apiece, and the manufacturers so far havent shown any willingness to compete on cost, he said.
“The results were seeing in Zest and the other trials dont really argue for choosing one stent over another,” Smith said. “In that setting, price is going to become a bigger factor to consider.”
Cypher More Effective
The Zest researchers found Cypher more effective at keeping arteries open, and at least as safe, as Medtronics Endeavor and Taxus Liberte. The study, partly funded by Medtronic, found Endeavor equally as effective as Taxus Liberte and safer.
“Theres a significant difference in disfavor of Endeavor” and for Cypher, said Stephan Windecker, a cardiologist at the University of Bern in Switzerland.
The trial results demonstrate “not all drug-eluting stents are the same,” said Christopher Allman, a J&J spokesman, in an e-mail. “Only Cypher has shown sustained patient outcomes now out to six years, which is another point of differentiation among drug eluting stents.”
The study showed Endeavor to be “non-inferior” to Cypher in terms of safety, while it had 29 percent fewer deaths, heart attacks and repeat procedures than the better-selling Liberte, said Joseph McGrath, a Medtronic spokesman, in an e-mail.
Fewer Clots
The trial found a much lower rate of clotting for Cypher and higher rates of repeat procedures for Liberte than past studies, so conclusions should be tempered by those past results, said Donald Baim, Boston Scientifics chief medical officer.
“This data doesnt jibe with what we know with all the other trials,” Baim said in an interview.
Boston Scientific has kept its grip on the market partly due to its two offerings, Taxus Liberte and Promus, Baim said. Each has a different drug coating and underlying architecture that serve different types of patients, he said.
Heart Scans Costing $2,000 Each Unneeded In One Of Five Cases
Almost one-quarter of the unneeded tests were ordered by doctors who werent heart specialists, according to research reported today at the American College of Cardiology meeting in Orlando, Florida. Some heart doctors may give the test to assure “worried well” patients, even if they dont have sufficient symptoms to warrant a scan, said Michael Crawford, chief of cardiology at the University of California at San Francisco.
“The consumer asks a cardiologist, Am I going to drop dead?” said Crawford, who was not involved in the study, in a telephone interview. “You think: Probably not. But gee, if the person drops dead, is the family going to sue me?”
The research, supported by both insurer and cardiologist groups, reviewed 3,035 so-called nuclear heart scans involving 6,351 patients. It found that 66 percent were appropriate. Another 18 percent werent needed and 16 percent were ambiguous. The tests, which measures blood flow at rest and during exercise to identify possible blockages, are the second largest expense for Unitedhealth Group Inc. after office visits, said Chad Peel, vice president of cardiology services at the insurers United Healthcare unit, in a telephone interview.
Reining in runaway imaging tests could save $260 million to help fund health-care reform, U.S. President Barack Obama said in his budget proposal to Congress.
Nearly Double
Use of all types of diagnostic imaging tests rose 44 percent in 2007 from 2002, nearly double the 23 percent growth in overall physician services per patient, the Medicare Payment Advisory Commission, or MedPAC, said in a March 2009 report to Congress.
The study measured use of nuclear heart scans, called SPECT MPI, or single-photon emission computed tomography myocardial perfusion imaging. Researchers used a computer program that weighed symptoms such as chest pain and factors such as age, high blood pressure, diabetes and history of smoking to identify unjustified tests. It flagged doctors when they didnt justify the test in some patients, the authors said.
“We need to be better stewards of our health-care dollar,” Ralph Brindis, a co-author of the report and senior adviser for cardiovascular disease at Northern California Kaiser Permanente, said in an interview. “To get the best kick for the buck, we want to do the right test for the right person at the right time.”
Use of the nuclear screens, developed 20 years ago, has been debated. MedPAC and other critics have focused on “self- dealing” specialist doctors who earn income from using their own diagnostic equipment.
Incentive to Use Them
“Once providers purchase machines, they have an incentive to use them as frequently as possible,” said MedPAC chairman Glenn M. Hackbarth in March 17 testimony to the subcommittee on health of the House Ways and Means Committee.
GE Healthcare, a unit of General Electric Co. in Fairfield, Connecticut; Philips Healthcare, a unit of Royal Philips Electronics in the Netherlands, and Siemens Healthcare, a unit of Siemens AG in Munich, Germany, are among companies that make the machines.
Study Funders
The study was funded by the American College of Cardiology Foundation and United Healthcare, a unit of UnitedHealth Group Inc. of Minnetonka, Minnesota, the largest U.S. supplier of medical benefits. The American Society of Nuclear Cardiology was also a partner in the study.
The research began in 2007. Doctors at six practices across the U.S. used computers to enter data on patients referred for nuclear heart scans that check for signs of heart disease.
The computers were equipped with a program containing guidelines on who should get the tests. The guidelines, previously drawn up by the cardiology college, incorporated almost 100 medical criteria and recommended the tests for people who had symptoms, such as pain while resting or that worsened during exercise, or heart rhythm disturbances, which suggested they had a high risk of coronary artery disease and imminent heart attack.
“Doctors are competitive souls; we dont want to be the ones with highest inappropriate numbers,” said study leader Robert Hendel, a cardiologist with Midwest Heart Specialists in Winfield, Illinois, and one of the authors of the study. Grading and feedback helped one medical practice group trim many unneeded tests to 13 percent from 22 percent, he said.
Alternative Test