Friday, July 14, 2006
Too Many Doctors in the House
July 10, 2006Op-Ed ContributorToo Many Doctors in the House By DAVID C. GOODMANDavid C. Goodman is a professor of pediatrics and family medicine atDartmouth Medical School.Hanover, N.H.CAN we cure our ailing health care system by sending in more doctors? Thatis the treatment prescribed by the Association of American Medical Colleges,which has recommended increasing the number of doctors they train by 30percent, in large part to keep up with the growing number of elderlypatients. But the most serious problems facing our health care system -accelerating costs, poor quality of care and the rising ranks of theuninsured - cannot be solved by more doctors. In fact, that approach, likeprescribing more drugs for an already overmedicated patient, may only makethings worse. Many studies have demonstrated that quality of care does not rise along withthe number of doctors. Compare Miami and Minneapolis, for example. Miami has40 percent more doctors per capita than Minneapolis has, and 50 percent morespecialists, according to The Dartmouth Atlas of Health Care, a study ofAmerican health care markets (for which I am an investigator).The elderly in Miami are subjected to more medical interventions - moreechocardiograms and mechanical ventilation in their last six months of life,for example - than elderly patients in Minneapolis are. This also means morehospitalizations, more days in intensive care units, more visits tospecialists and more diagnostic tests for the elderly in Miami. It certainlyleads to many more doctors employed in Florida. But does this expensiveadditional medical activity benefit patients? Apparently not. The elderly in places like Miami do not live longer thanthose in cities like Minneapolis. According to the Medicare CurrentBeneficiary Survey, which polls some 12,000 elderly Americans about theirhealth care three times a year, residents of regions with relatively largenumbers of doctors are no more satisfied with their care than the elderlywho live in places with fewer doctors. And various studies have demonstratedthat the essential quality of care in places like Miami - whether you aretalking about the treatment of colon cancer, heart attacks or any otherspecific ailment - is no higher than in cities like Minneapolis. Studies of individual hospitals have likewise shown that while thedoctor-patient ratio varies widely from place to place, more doctors do notmean better care.The Mayo Clinic in Rochester, Minn., and the University of California, SanFrancisco, Medical Center each have about one doctor treating every 100elderly patients with chronic illnesses in their last six months of life.New York University Medical Center has 2.8 doctors for every 100 suchpatients and the University of California, Los Angeles, Medical Center has1.7. The elderly patients at N.Y.U. and U.C.L.A., as compared with those atthe Mayo Clinic and the San Francisco hospital, see more specialists and aresubjected to more imaging tests and other procedures. But the quality oftheir care, as judged by doctors, is no better.Using the N.Y.U. doctor-patient ratio as a benchmark for determining thenumber of physicians that will be needed to care for the over-65 populationin the year 2020, we can project a deficit of more than 44,000 doctorsnationwide. But if the benchmark is based on the Mayo ratio, we can projectan excess of nearly 50,000 doctors in the year 2020.How can it be that more spending and greater physician effort does not leadto better health or to improvements in patient satisfaction? One explanationmay be that when more doctors are around, patients spend more time inhospitals, and hospitals are risky places. More than 100,000 deaths a yearare estimated to be caused by medical mishaps.The association of medical colleges has argued that increasing the doctorsupply overall can remedy regional shortages. But in the past 20 years, asthe number of doctors per capita grew by more than 50 percent, according toour measurements, most of the new ones settled in areas where the supply wasalready above average - places like Florida or New York - rather than inregions that lack doctors, like the rural South. Medical training is anexpensive business, and it makes little sense to waste additional publicdollars to perpetuate doctors' preference to live in affluent places.By training more doctors than we need, we will continue to fill morehospital beds, order more diagnostic tests - in short, spend more money. Butour resources would be better directed toward improving efforts to preventillness and manage chronic ailments like diabetes and heart disease. Better coordination of care is also worth investment. Small physician groupsin disconnected offices often provide fragmented treatments, whilemultispecialty practices integrated with hospitals - prevalent inMinneapolis and some other cities - are associated with lower cost andhigher quality of care. All these strategies have been shown to improve patient outcomes withoutadding physicians. Instead of training more doctors, let's make better useof the ones we already have.
Internal Review Questions FDA's Commitment To Drug Safety
An internal report has faulted the Food and Drug Administration for not aggressively following up with drug manufacturers to monitor their progress in conducting safety studies.
The Inspector General of the U.S. Department of Health and Human Services has conducted a review of FDA monitoring performance, finding that 35 percent of status reports that drug makers were supposed to file in fiscal year 2004 were missing entirely or contained no information on agreed-to studies.
"Monitoring post-marketing study commitments is not a top priority," the study concluded.
Post-marketing studies are conducted once a drug has been approved for the marketplace. They can be important because the actual approval is often based on limited clinical trials. Aftermarket studies can reveal what unforeseen effects the drug is having among the population using it.
Though it was not revealed by an post-market study, problems with the pain reliever Vioxx did not emerge until the drug had been in use for a number of years. It was, in fact, another set of clinical trials that established a link between the popular arthritis drug made by Merck & Co. and an increased risk of heart attack and stroke.
According to the Inspector General's report, only about half of new drug applications approved from 1990 through 2004 included at least one commitment for a postmarketing study.
But the report concludes that the FDA cannot readily identify what kind of progress drug companies are making with their studies. The report further found that even the status reports that are completed sometimes leave out data that would help the agency monitor the progress of safety studies.
The FDA took issue with the report, saying the conclusion that it cannot monitor safety studies is not accurate.
The Inspector General of the U.S. Department of Health and Human Services has conducted a review of FDA monitoring performance, finding that 35 percent of status reports that drug makers were supposed to file in fiscal year 2004 were missing entirely or contained no information on agreed-to studies.
"Monitoring post-marketing study commitments is not a top priority," the study concluded.
Post-marketing studies are conducted once a drug has been approved for the marketplace. They can be important because the actual approval is often based on limited clinical trials. Aftermarket studies can reveal what unforeseen effects the drug is having among the population using it.
Though it was not revealed by an post-market study, problems with the pain reliever Vioxx did not emerge until the drug had been in use for a number of years. It was, in fact, another set of clinical trials that established a link between the popular arthritis drug made by Merck & Co. and an increased risk of heart attack and stroke.
According to the Inspector General's report, only about half of new drug applications approved from 1990 through 2004 included at least one commitment for a postmarketing study.
But the report concludes that the FDA cannot readily identify what kind of progress drug companies are making with their studies. The report further found that even the status reports that are completed sometimes leave out data that would help the agency monitor the progress of safety studies.
The FDA took issue with the report, saying the conclusion that it cannot monitor safety studies is not accurate.
Grading Surgeons May Be Healthy Practice
"In a society that champions consumer choice and market forces as the bestways to do nearly everything, medicine stands out as an exception. Most Americans know very little about choosing, say, a heart surgeon. They simply take their primary-care physician's advice or blindly pick asurgeon from those covered by their insurance plan. For more than a decade,a handful of states, notably Pennsylvania and New York, have been issuingpublic report cards on individual surgeons that show the rates of death andcomplication of their heart-bypass patients. After all, practicing doctorsand nurses know which surgeons are good, and which are to be avoided.Shouldn't the rest of us know, too? But report cards remain surprisinglycontroversial, and not only among doctors being graded. Daniel Kessler, aStanford University economist, divides the debate into three camps. One saysreport cards boost the quality of health care. A second says they don't havemuch effect, good or bad, because ordinary patients ignore them."Wall Street Journal, David Wessel Read the Full Article
Forget tort reform. The Democrats have a better diagnosis.
By Ezra KleinPosted Tuesday, July 11, 2006, at 6:20 AM ET
The Republican answer to runaway health-care spending is to cap jury awards in medical malpractice suits. For the fifth time in four years, Senate Majority Leader Bill Frist tried and failed to cap awards at $250,000 during his self-proclaimed "Health Care Week" in May. But this time, the Democrats put a better idea on the table.
Sens. Hillary Clinton and Barack Obama also want to save on health care. But rather than capping jury awards, they hope to cut the number of medical malpractice cases by reducing medical errors, as they explain in an article in the New England Journal of Medicine. In other words, to the Republicans, suits and payouts are the ill. To the Democrats, the problem is a slew of medical injuries of which the suits are a symptom. The latest evidence shows the Democrats' diagnosis to be right.
The best attempt to synthesize the academic literature on medical malpractice is Tom Baker's The Medical Malpractice Myth, published last November. Baker, a law professor at the University of Connecticut who studies insurance, argues that the hype about medical malpractice suits is "urban legend mixed with the occasional true story, supported by selective references to academic studies." After all, including legal fees, insurance costs, and payouts, the cost of the suits comes to less than one-half of 1 percent of health-care spending. If anything, there are fewer lawsuits than would be expected, and far more injuries than we usually imagine.
As proof, Baker marshals an overwhelming array of research. The most impressive and comprehensive study is by the Harvard Medical Practice released in 1990. The Harvard researchers took a huge sample of 31,000 medical records, dating from the mid-1980s, and had them evaluated by practicing doctors and nurses, the professionals most likely to be sympathetic to the demands of the doctor's office and operating room. The records went through multiple rounds of evaluation, and a finding of negligence was made only if two doctors, working independently, separately reached that conclusion. Even with this conservative methodology, the study found that doctors were injuring one out of every 25 patients—and that only 4 percent of these injured patients sued.
The Harvard study stands for a large body of literature. On their own, however, the results don't disprove the Republicans' thesis that many medical malpractice suits are frivolous. Maybe badly injured patients don't sue, while the reflexively litigious clog up the legal system, making tort reform a viable solution. But a new study, released in May, demolishes that possibility. Dr. David Studdert led a team of eight researchers from Harvard Medical School and Brigham Young University who examined 1,452 medical malpractice lawsuits. They found that more than 90 percent of the claims showed evidence of medical injury, which means they weren't frivolous. In 60 percent of these cases, the injury resulted from physician wrongdoing. In a quarter of the claims, the patient died.
When baseless medical malpractice suits were brought, the study further found, the courts efficiently threw them out. Only 150 of the cases in which the researchers couldn't detect injury received even token compensation. Indeed, a bigger problem was that 256 cases were thrown out of court despite evidence of harm to patients by physicians. The other 1,046 cases, in the research team's opinion, were decided correctly, with damage awards going to the injured and dismissal foiling the frivolous suits.
Nor is there evidence to show that the level of jury awards has shot up. A recent RAND study looked at the growth in malpractice awards between 1960 and 1999. "Our results are striking," the research team concluded. "Not only do we show that real average awards have grown by less than real income over the 40 years in our sample, we also find that essentially all of this growth can be explained by changes in observable case characteristics and claimed economic losses."
Which brings us back to the Republicans' and Democrats' divergent approaches. The Obama-Clinton legislation fits well with Studdert's and RAND's findings. It also builds on successful efforts by the nation's anesthesiologists and a few hospitals to reduce their medical malpractice payouts.
Anesthesiologists used to get hit with the most malpractice lawsuits and some of the highest insurance premiums. Then in the late 1980s, the American Society of Anesthesiologists launched a project to analyze every claim ever brought against its members and develop new ways to reduce medical error. By 2002, the specialty had one of the highest safety ratings in the profession, and its average insurance premium plummeted to its 1985 level, bucking nationwide trends. Similarly, feeling embattled by a high rate of malpractice claims, the University of Michigan Medical System in 2002 analyzed all adverse claims and used the data to restructure procedures to guard against error. Since instituting the program, the number of suits has dropped by half, and the university's annual spending on malpractice litigation is down two-thirds. And at the Lexington, Ky., Veterans Affairs Medical Center, a program of early disclosure and settlement of malpractice claims lowered average settlement costs to $15,000, compared with $83,000 for other VA hospitals.
Clinton and Obama would offer federal grants and support to unroll such programs nationwide. And they want to create a national database to track incidents of malpractice and fund research into standards, procedures, and technologies that would prevent future injuries. So, what say you, Bill Frist? It is time for another Health Care Week?
The Republican answer to runaway health-care spending is to cap jury awards in medical malpractice suits. For the fifth time in four years, Senate Majority Leader Bill Frist tried and failed to cap awards at $250,000 during his self-proclaimed "Health Care Week" in May. But this time, the Democrats put a better idea on the table.
Sens. Hillary Clinton and Barack Obama also want to save on health care. But rather than capping jury awards, they hope to cut the number of medical malpractice cases by reducing medical errors, as they explain in an article in the New England Journal of Medicine. In other words, to the Republicans, suits and payouts are the ill. To the Democrats, the problem is a slew of medical injuries of which the suits are a symptom. The latest evidence shows the Democrats' diagnosis to be right.
The best attempt to synthesize the academic literature on medical malpractice is Tom Baker's The Medical Malpractice Myth, published last November. Baker, a law professor at the University of Connecticut who studies insurance, argues that the hype about medical malpractice suits is "urban legend mixed with the occasional true story, supported by selective references to academic studies." After all, including legal fees, insurance costs, and payouts, the cost of the suits comes to less than one-half of 1 percent of health-care spending. If anything, there are fewer lawsuits than would be expected, and far more injuries than we usually imagine.
As proof, Baker marshals an overwhelming array of research. The most impressive and comprehensive study is by the Harvard Medical Practice released in 1990. The Harvard researchers took a huge sample of 31,000 medical records, dating from the mid-1980s, and had them evaluated by practicing doctors and nurses, the professionals most likely to be sympathetic to the demands of the doctor's office and operating room. The records went through multiple rounds of evaluation, and a finding of negligence was made only if two doctors, working independently, separately reached that conclusion. Even with this conservative methodology, the study found that doctors were injuring one out of every 25 patients—and that only 4 percent of these injured patients sued.
The Harvard study stands for a large body of literature. On their own, however, the results don't disprove the Republicans' thesis that many medical malpractice suits are frivolous. Maybe badly injured patients don't sue, while the reflexively litigious clog up the legal system, making tort reform a viable solution. But a new study, released in May, demolishes that possibility. Dr. David Studdert led a team of eight researchers from Harvard Medical School and Brigham Young University who examined 1,452 medical malpractice lawsuits. They found that more than 90 percent of the claims showed evidence of medical injury, which means they weren't frivolous. In 60 percent of these cases, the injury resulted from physician wrongdoing. In a quarter of the claims, the patient died.
When baseless medical malpractice suits were brought, the study further found, the courts efficiently threw them out. Only 150 of the cases in which the researchers couldn't detect injury received even token compensation. Indeed, a bigger problem was that 256 cases were thrown out of court despite evidence of harm to patients by physicians. The other 1,046 cases, in the research team's opinion, were decided correctly, with damage awards going to the injured and dismissal foiling the frivolous suits.
Nor is there evidence to show that the level of jury awards has shot up. A recent RAND study looked at the growth in malpractice awards between 1960 and 1999. "Our results are striking," the research team concluded. "Not only do we show that real average awards have grown by less than real income over the 40 years in our sample, we also find that essentially all of this growth can be explained by changes in observable case characteristics and claimed economic losses."
Which brings us back to the Republicans' and Democrats' divergent approaches. The Obama-Clinton legislation fits well with Studdert's and RAND's findings. It also builds on successful efforts by the nation's anesthesiologists and a few hospitals to reduce their medical malpractice payouts.
Anesthesiologists used to get hit with the most malpractice lawsuits and some of the highest insurance premiums. Then in the late 1980s, the American Society of Anesthesiologists launched a project to analyze every claim ever brought against its members and develop new ways to reduce medical error. By 2002, the specialty had one of the highest safety ratings in the profession, and its average insurance premium plummeted to its 1985 level, bucking nationwide trends. Similarly, feeling embattled by a high rate of malpractice claims, the University of Michigan Medical System in 2002 analyzed all adverse claims and used the data to restructure procedures to guard against error. Since instituting the program, the number of suits has dropped by half, and the university's annual spending on malpractice litigation is down two-thirds. And at the Lexington, Ky., Veterans Affairs Medical Center, a program of early disclosure and settlement of malpractice claims lowered average settlement costs to $15,000, compared with $83,000 for other VA hospitals.
Clinton and Obama would offer federal grants and support to unroll such programs nationwide. And they want to create a national database to track incidents of malpractice and fund research into standards, procedures, and technologies that would prevent future injuries. So, what say you, Bill Frist? It is time for another Health Care Week?
Artificial Blood Experiment: Is Your City Participating?
ABC World News Tonight July 7, 2006, By ASA R. ESLOCKER and ASTRID HILL
July 7, 2006 - - Northfield Lab's experimental blood substitute Polyheme iscurrently in randomized phase III clinical trials recruiting patientswithout informed consent all over the country. At one point, it was beingtested in as many as 27 cities; it is still being tested in 23 hospitals in20 cities. With the FDA's approval, Northfield Lab has recruited hospitals toparticipate in the trial study with exemption from informed consentrequirements on study participants. Although Northfield Lab claims thatextensive information on the study has been made public, a vast majority ofthe general public has never heard of the trial.Below is a list of the cities and hospitals that are currently participatingin the Polyheme trials. Check the list to see if you live an area where youcould become a trial participant without your informed consent. To opt out of the study, contact Northfield Labs(http://www.northfieldlabs.com/contact.html) or a participating hospital andrequest a blue bracelet. If worn, you will be exempt from the trial.CaliforniaUC San Diego Medical Center, San Diego, Calif.; No longer recruiting Scripps Mercy, San Diego, Calif.; No longer recruitingColoradoDenver Health Medical Center, Denver, Colo.DelawareChristiana Hospital, Newark, Del.GeorgiaMedical Center of Central Georgia, Macon, Ga.IllinoisLoyola University Medical Center, Maywood, Ill.IndianaWishard Memorial Hospital, Indianapolis, Ind. Methodist Hospital of Indiana, Indianapolis, Ind. KansasUniversity of Kansas Medical Center, Kansas City, Kan.KentuckyUniversity of Kentucky Medical Center, Lexington, Ky.MichiganDetroit Receiving Hospital, Detroit, Mich. Sinai Grace Hospital, Detroit, Mich. MinnesotaThe Mayo Clinic, Rochester, Minn.New YorkAlbany Medical Center, Albany, N.Y.; SuspendedNorth CarolinaDuke University Medical Center, Durham, N.C.OhioMetroHealth Medical Center, Cleveland, Ohio; Suspended University of Cincinnati Medical Center, Cincinnati, Ohio Miami Valley Hospital, Dayton, Ohio PennsylvaniaLehigh Valley Hospital, Allentown, Penn.; No longer recruiting St. Luke's Regional Resource Trauma Center, Bethlehem, Penn.Penn State Milton S. Hershey Medical Center, Hershey, Penn.TennesseeUniversity of Tennessee-Memphis, Memphis, Tenn. Johnson City Medical Center, Johnson City, Tenn.; SuspendedTexasMemorial-Hermann Hospital, Houston, Texas; No longer recruiting Memorial-Hermann Hospital, Houston, Texas; No longer recruiting University of Texas Health Science Center, San Antonio, Texas Brooke Army Medical Center, Fort Sam, Houston, TexasUtahUniversity of Utah Health Sciences Center, Salt Lake City, Utah LDS Hospital, Salt Lake City, UtahVirginiaSentara Norfolk Hospital, Norfolk, Va.; No longer recruiting Virginia Commonwealth University Medical Center, Richmond, Va.Inova Fairfax Hospital, Falls Church, Va.; Suspended West VirginiaWest Virginia University/Jon Michael Moore Trauma Center, Morgantown, WestVa.(source: www.clinicaltrials.gov where it says "Verified by NorthfieldLaboratories June 2006)(http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1)Copyright (c) 2006 ABC News Internet Ventures
July 7, 2006 - - Northfield Lab's experimental blood substitute Polyheme iscurrently in randomized phase III clinical trials recruiting patientswithout informed consent all over the country. At one point, it was beingtested in as many as 27 cities; it is still being tested in 23 hospitals in20 cities. With the FDA's approval, Northfield Lab has recruited hospitals toparticipate in the trial study with exemption from informed consentrequirements on study participants. Although Northfield Lab claims thatextensive information on the study has been made public, a vast majority ofthe general public has never heard of the trial.Below is a list of the cities and hospitals that are currently participatingin the Polyheme trials. Check the list to see if you live an area where youcould become a trial participant without your informed consent. To opt out of the study, contact Northfield Labs(http://www.northfieldlabs.com/contact.html) or a participating hospital andrequest a blue bracelet. If worn, you will be exempt from the trial.CaliforniaUC San Diego Medical Center, San Diego, Calif.; No longer recruiting Scripps Mercy, San Diego, Calif.; No longer recruitingColoradoDenver Health Medical Center, Denver, Colo.DelawareChristiana Hospital, Newark, Del.GeorgiaMedical Center of Central Georgia, Macon, Ga.IllinoisLoyola University Medical Center, Maywood, Ill.IndianaWishard Memorial Hospital, Indianapolis, Ind. Methodist Hospital of Indiana, Indianapolis, Ind. KansasUniversity of Kansas Medical Center, Kansas City, Kan.KentuckyUniversity of Kentucky Medical Center, Lexington, Ky.MichiganDetroit Receiving Hospital, Detroit, Mich. Sinai Grace Hospital, Detroit, Mich. MinnesotaThe Mayo Clinic, Rochester, Minn.New YorkAlbany Medical Center, Albany, N.Y.; SuspendedNorth CarolinaDuke University Medical Center, Durham, N.C.OhioMetroHealth Medical Center, Cleveland, Ohio; Suspended University of Cincinnati Medical Center, Cincinnati, Ohio Miami Valley Hospital, Dayton, Ohio PennsylvaniaLehigh Valley Hospital, Allentown, Penn.; No longer recruiting St. Luke's Regional Resource Trauma Center, Bethlehem, Penn.Penn State Milton S. Hershey Medical Center, Hershey, Penn.TennesseeUniversity of Tennessee-Memphis, Memphis, Tenn. Johnson City Medical Center, Johnson City, Tenn.; SuspendedTexasMemorial-Hermann Hospital, Houston, Texas; No longer recruiting Memorial-Hermann Hospital, Houston, Texas; No longer recruiting University of Texas Health Science Center, San Antonio, Texas Brooke Army Medical Center, Fort Sam, Houston, TexasUtahUniversity of Utah Health Sciences Center, Salt Lake City, Utah LDS Hospital, Salt Lake City, UtahVirginiaSentara Norfolk Hospital, Norfolk, Va.; No longer recruiting Virginia Commonwealth University Medical Center, Richmond, Va.Inova Fairfax Hospital, Falls Church, Va.; Suspended West VirginiaWest Virginia University/Jon Michael Moore Trauma Center, Morgantown, WestVa.(source: www.clinicaltrials.gov where it says "Verified by NorthfieldLaboratories June 2006)(http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1)Copyright (c) 2006 ABC News Internet Ventures
FDA to Weigh Using Fake Blood in Trauma Trial
July 11, Wall Street Journal
By THOMAS M. BURTONIf the U.S. Navy gets its way, hundreds of civilian trauma patients could --without their consent -- be given a blood substitute that has been linked inother large clinical studies to increases in hypertension, heart attacks andother serious cardiac problems.The Food and Drug Administration has blocked the new Navy trial three timesin the past year, but now is reconsidering after months of jockeying amongthe Navy, the agency and Biopure Corp., the Cambridge, Mass., maker of theblood substitute.The agency has scheduled a closed-door hearing for next week on whether theNavy-designed trial can proceed. More than 900 badly hemorrhaging civilianaccident victims around the country would be involved, with paramedicsgiving some the blood substitute, called Hemopure, and others salinesolution en route to hospitals.Such non-consent studies are rare but legal where federal regulatorsdetermine there's no practical way to obtain consent, such as when patientsare in shock or unconscious. There also must be a reasonable likelihood thatindividual patients would benefit from the treatment under scrutiny.Scientists have been hunting for a safe, workable blood substitute fordecades. Artificial blood, with oxygen-carrying ability, could eliminate theneed to match blood types of donor and recipient in some settings, and enjoya far longer shelf life than donor blood. It could also reduce the risk ofhepatitis or HIV infection, although donor blood has become very safe overthe past two decades.The Navy, which provides all medical care for injured U.S. marines andsailors, has been particularly eager for a workable blood substitute. Donorblood lasts only about 42 days before its oxygen-carrying capacity isdiminished, while artificial blood could be stored aboard ships for anestimated three years.But efforts to develop blood substitutes have encountered safety problemsover the years. Some companies have gone out of business or exitedblood-substitute research when past efforts failed.Northfield Laboratories of Evanston, Ill., is nearing completion of acivilian non-consent study involving its own blood substitute, PolyHeme, and720 trauma patients around the country. In a previous trial of surgerypatients, 10 of 81 people who received PolyHeme suffered heart attacks,versus zero of 71 receiving donor blood. Northfield says it doesn't believeits product caused the heart attacks, but the Securities and ExchangeCommission and Sen. Charles Grassley, chairman of the Senate FinanceCommittee, are investigating whether the company properly disclosed thoseresults in federal filings and community meetings. Northfield says it iscooperating with the investigations but declined to comment further. Nine ofthe original 31 medical centers that agreed to participate in the trial areno longer testing patients with PolyHeme.Past studies have raised questions about Biopure's Hemopure as well. In1998, the company began a clinical study comparing its substitute with donorblood in consenting orthopedic-surgery patients. William G. Hoffman, thenBiopure's medical director and now director of cardiac-surgery critical careat Massachusetts General Hospital, says he concluded during the study thatthe blood substitute wasn't working well and was "harmful," and urgedBiopure to stop the trial. Edward Jacobs, a Biopure founder and then seniorvice president, says the company consulted outside cardiologists and "theiropinion was to go ahead."Evidence from that study, along with a separate study in general surgerypatients, linked Hemopure to more complications such as strokes andmini-strokes than donor blood, FDA documents show. Biopure disputes some ofthe FDA numbers. But in a draft response to the agency, Biopure acknowledgesthat there were more cases of cardiac arrest, more fluid in the lungs andmore hypertension among patients who got Hemopure than those who receiveddonor blood.Navy officials declined to comment on why they want to conduct a trial witha product that has shown such negative side effects. But in documentssubmitted to the FDA, the Navy has maintained that a study of traumapatients would be significantly different from the trial with surgerypatients. The Navy also argues that the oxygen-carrying capacity ofBiopure's product could lower the death rate in trauma patients by 25%versus patients getting saline. "If we could replace saline with the thingthat we need most, oxygen-carrying capacity, that would be the best," saysthe Navy's Surgeon General Vice Admiral Donald Arthur. "Our interest is infield conditions where there is no blood."Biopure's vice president for medical affairs, A. Gerson Greenburg, says thecompany's product "has an acceptable safety profile" and that a bloodsubstitute can serve "a societal good whereby you're saving [donor] bloodfor other people." He says many adverse events in past studies weren'tnecessarily linked to Hemopure.The Navy proposed the new study of civilian trauma patients in 2004, sayingthat conducting such a study in combat wouldn't be practical. Documents showthe FDA concluded, based on its review of existing Biopure research onsurgery patients, that there were "highly significant differences" showingmore "serious adverse events" with Hemopure than with blood. On July 8,2005, the FDA told the Navy its study couldn't proceed "because subjectswould be exposed to an unreasonable and significant risk of injury."Daniel Freilich, who heads Navy blood-substitute research, responded with aseries of letters criticizing the FDA, writing in one that the agency'sstance "is not scientifically and clinically rigorous." The Navy also arguedthat the FDA had permitted Biopure's competitor, Northfield, to pursue itsown study with a similar product.On Oct. 13, Biopure CEO Zafiris G. Zafirelis wrote to Jesse Goodman,director of the FDA's Center for Biologics Evaluation and Research,suggesting that an FDA reviewer wasn't objective and had a possible conflictof interest. In March, the FDA's Dr. Goodman wrote to Mr. Zafirelis that hehad assigned three other high-ranking officials to preside over Biopuredecisions, according to the people familiar with the matter.Earlier this year, the FDA scheduled the advisory panel meeting for nextweek. In an unusual step, the Navy, the sponsor of the proposed research,was able to recommend some doctors to be on the panel. Additionally, twowell-known skeptics of substitutes who initially had been named as advisoryconsultants to the panel -- Charles Natanson, a critical-care specialistwith the National Institutes of Health and John Hess, director of theUniversity of Maryland's blood bank -- have in recent weeks been disinvited.Neither FDA officials, Dr. Natanson, Dr. Hess nor Dr. Goodman would commentfor this article.
By THOMAS M. BURTONIf the U.S. Navy gets its way, hundreds of civilian trauma patients could --without their consent -- be given a blood substitute that has been linked inother large clinical studies to increases in hypertension, heart attacks andother serious cardiac problems.The Food and Drug Administration has blocked the new Navy trial three timesin the past year, but now is reconsidering after months of jockeying amongthe Navy, the agency and Biopure Corp., the Cambridge, Mass., maker of theblood substitute.The agency has scheduled a closed-door hearing for next week on whether theNavy-designed trial can proceed. More than 900 badly hemorrhaging civilianaccident victims around the country would be involved, with paramedicsgiving some the blood substitute, called Hemopure, and others salinesolution en route to hospitals.Such non-consent studies are rare but legal where federal regulatorsdetermine there's no practical way to obtain consent, such as when patientsare in shock or unconscious. There also must be a reasonable likelihood thatindividual patients would benefit from the treatment under scrutiny.Scientists have been hunting for a safe, workable blood substitute fordecades. Artificial blood, with oxygen-carrying ability, could eliminate theneed to match blood types of donor and recipient in some settings, and enjoya far longer shelf life than donor blood. It could also reduce the risk ofhepatitis or HIV infection, although donor blood has become very safe overthe past two decades.The Navy, which provides all medical care for injured U.S. marines andsailors, has been particularly eager for a workable blood substitute. Donorblood lasts only about 42 days before its oxygen-carrying capacity isdiminished, while artificial blood could be stored aboard ships for anestimated three years.But efforts to develop blood substitutes have encountered safety problemsover the years. Some companies have gone out of business or exitedblood-substitute research when past efforts failed.Northfield Laboratories of Evanston, Ill., is nearing completion of acivilian non-consent study involving its own blood substitute, PolyHeme, and720 trauma patients around the country. In a previous trial of surgerypatients, 10 of 81 people who received PolyHeme suffered heart attacks,versus zero of 71 receiving donor blood. Northfield says it doesn't believeits product caused the heart attacks, but the Securities and ExchangeCommission and Sen. Charles Grassley, chairman of the Senate FinanceCommittee, are investigating whether the company properly disclosed thoseresults in federal filings and community meetings. Northfield says it iscooperating with the investigations but declined to comment further. Nine ofthe original 31 medical centers that agreed to participate in the trial areno longer testing patients with PolyHeme.Past studies have raised questions about Biopure's Hemopure as well. In1998, the company began a clinical study comparing its substitute with donorblood in consenting orthopedic-surgery patients. William G. Hoffman, thenBiopure's medical director and now director of cardiac-surgery critical careat Massachusetts General Hospital, says he concluded during the study thatthe blood substitute wasn't working well and was "harmful," and urgedBiopure to stop the trial. Edward Jacobs, a Biopure founder and then seniorvice president, says the company consulted outside cardiologists and "theiropinion was to go ahead."Evidence from that study, along with a separate study in general surgerypatients, linked Hemopure to more complications such as strokes andmini-strokes than donor blood, FDA documents show. Biopure disputes some ofthe FDA numbers. But in a draft response to the agency, Biopure acknowledgesthat there were more cases of cardiac arrest, more fluid in the lungs andmore hypertension among patients who got Hemopure than those who receiveddonor blood.Navy officials declined to comment on why they want to conduct a trial witha product that has shown such negative side effects. But in documentssubmitted to the FDA, the Navy has maintained that a study of traumapatients would be significantly different from the trial with surgerypatients. The Navy also argues that the oxygen-carrying capacity ofBiopure's product could lower the death rate in trauma patients by 25%versus patients getting saline. "If we could replace saline with the thingthat we need most, oxygen-carrying capacity, that would be the best," saysthe Navy's Surgeon General Vice Admiral Donald Arthur. "Our interest is infield conditions where there is no blood."Biopure's vice president for medical affairs, A. Gerson Greenburg, says thecompany's product "has an acceptable safety profile" and that a bloodsubstitute can serve "a societal good whereby you're saving [donor] bloodfor other people." He says many adverse events in past studies weren'tnecessarily linked to Hemopure.The Navy proposed the new study of civilian trauma patients in 2004, sayingthat conducting such a study in combat wouldn't be practical. Documents showthe FDA concluded, based on its review of existing Biopure research onsurgery patients, that there were "highly significant differences" showingmore "serious adverse events" with Hemopure than with blood. On July 8,2005, the FDA told the Navy its study couldn't proceed "because subjectswould be exposed to an unreasonable and significant risk of injury."Daniel Freilich, who heads Navy blood-substitute research, responded with aseries of letters criticizing the FDA, writing in one that the agency'sstance "is not scientifically and clinically rigorous." The Navy also arguedthat the FDA had permitted Biopure's competitor, Northfield, to pursue itsown study with a similar product.On Oct. 13, Biopure CEO Zafiris G. Zafirelis wrote to Jesse Goodman,director of the FDA's Center for Biologics Evaluation and Research,suggesting that an FDA reviewer wasn't objective and had a possible conflictof interest. In March, the FDA's Dr. Goodman wrote to Mr. Zafirelis that hehad assigned three other high-ranking officials to preside over Biopuredecisions, according to the people familiar with the matter.Earlier this year, the FDA scheduled the advisory panel meeting for nextweek. In an unusual step, the Navy, the sponsor of the proposed research,was able to recommend some doctors to be on the panel. Additionally, twowell-known skeptics of substitutes who initially had been named as advisoryconsultants to the panel -- Charles Natanson, a critical-care specialistwith the National Institutes of Health and John Hess, director of theUniversity of Maryland's blood bank -- have in recent weeks been disinvited.Neither FDA officials, Dr. Natanson, Dr. Hess nor Dr. Goodman would commentfor this article.
DEATHS LAUNCH NEW PROBE
State Health Department investigating after two children, 7 and 1, die following treatment at Stony Brook University HospitalBY RIDGELY OCHSNewsday Staff Writer
The recent unexpected deaths of two children at Stony Brook University Hospital have prompted investigations by the state Department of Health.The department is investigating the June 26 death of 7-year-old Tyler Poole of West Islip following routine adenoid surgery. It also is continuing to probe the May 13 death of 1-year-old Amee Martin of Mastic.Citing a federal confidentiality law, the hospital declined to identify Tyler or Amee, or to otherwise discuss the cases, but the families involved confirmed the basic facts of the cases.Amee's mother, Judee, said the hospital told her that her daughter died from an overdose of papaverine, a drug that expands blood vessels. Amee was brought to the hospital because she suddenly stopped breathing, her mother said. The drug, which is supposed to be diluted for children, was given at full strength, according to hospital sources. Martin, whose daughter had a previous breathing episode on March 2 and was saved by two Suffolk police officers, said she is awaiting a hospital report before deciding whether to discuss her daughter's case in detail. "The nurses in the pediatric intensive care unit were phenomenal," she said. "However, what happened should never have happened."The health department said it is "reviewing all aspects on the care the child received, including allegations of medication overdose." Richard Poole said his son Tyler's heart stopped for unknown reasons June 26 after "simple in-and-out" surgery to remove his adenoids. Although his son suffered from Duchenne muscular dystrophy, he said all precautions appeared to have been taken to ensure his son's safety. "I pray that is the case," said Poole, who added he hoped his son's death would raise awareness of the genetic disease, especially through the nonprofit group Parent Project Muscular Dystrophy.Health department spokesman Robert Kenny said the hospital reported Amee's death to the department. The state's investigation into Tyler's death was prompted by an inquiry from a Newsday reporter, though the hospital reported it after that inquiry was made.The state investigates any "unexpected" deaths - those unanticipated given the patient's diagnosis - as well as medication or surgery errors, all of which hospitals are required to report to the state, Kenny said. Complaints can also trigger an investigation.He also said it was not unusual for a hospital to have two ongoing investigations."We never want to see it but it's not out of the ordinary," said Kenny, who said he could not predict when the investigations would be completed. In 2002, the health department cited Stony Brook for a number of deficiencies following the death of 6-day-old Gianni Vargas of Brentwood, who died after he was given 10 times the proper dose of potassium chloride. The health department found that the staff did not follow proper procedures to ensure dilution of the potassium chloride, that there was a lack of coordination among various departments, and that the pharmacy computer system was unable to detect dosing errors.The 504-bed Stony Brook facility, Suffolk's largest hospital, is the only one in the county to provide highly specialized or "tertiary" care. Although it would not discuss the details of the current cases, the hospital defended its "outstanding record of patient safety." It cited an overall mortality rate of 1.78 percent from January to April of this year, which it said is lower than a 2.3 percent rate from a consortium of university hospital centers it uses as a benchmark. "This success was achieved even while caring for the region's most acute patients," the hospital said in a statement. However, Yosef Dlugacz, senior vice president for quality management for North Shore-Long Island Jewish Health System, questioned whether overall mortality is "a quality indicator to be used as a benchmark in comparing one hospital's performance against another hospital's performance." Dlugacz, who is publishing a book on health care quality measurements next month, said he prefers comparing outcomes from a particular diagnosis or procedure. That's how most hospital report cards are compiled.The hospital also defended its efforts to ensure patient safety. "Stony Brook University Hospital has patient care quality and safety as its first priority and participates in Patient Safety Net, an online reporting system that makes it possible for anyone in the hospital to anonymously report a patient safety concern or issue," the hospital said in a statement.It is also participating in a nationwide program designed by Stanford University and in the Institute for Healthcare Improvement's 100,000 Lives Campaign to reduce avoidable patient deaths. "We exceeded our goal and have, using risk-adjustment methods, saved an estimated 130 lives over the past 18 months," the statement said.Cases of concernCiting two recent deaths, a senior Stony Brook University Hospital surgeon has raised questions about "patient safety" there. Following are some cases that have prompted state reviews.June 26, 2006: Tyler Poole, 7, of West Islip, died after routine adenoid surgery. Cause of death is unknown. May 13, 2006: Amee Martin, 1, of Mastic, died from an apparent overdose of /papaverineSeptember 2003: "Baby Doe" of Suffolk County died of heart illness following cardiac surgery.February 2002: Gianni Vargas, 6 days old, of Brentwood, died after he was given 10 times the dose of potassium chloride. August 1995: Petra Fiel, 8 days old, of Ronkonkoma, was given 10 times the correct dose of morphine. She recovered.Medication errors statewide, 20055 Resulted in permanent harm to patient10 Resulted in near-death situation11 Resulted in death of patientSTATE HEALTH DEPARTMENT
The recent unexpected deaths of two children at Stony Brook University Hospital have prompted investigations by the state Department of Health.The department is investigating the June 26 death of 7-year-old Tyler Poole of West Islip following routine adenoid surgery. It also is continuing to probe the May 13 death of 1-year-old Amee Martin of Mastic.Citing a federal confidentiality law, the hospital declined to identify Tyler or Amee, or to otherwise discuss the cases, but the families involved confirmed the basic facts of the cases.Amee's mother, Judee, said the hospital told her that her daughter died from an overdose of papaverine, a drug that expands blood vessels. Amee was brought to the hospital because she suddenly stopped breathing, her mother said. The drug, which is supposed to be diluted for children, was given at full strength, according to hospital sources. Martin, whose daughter had a previous breathing episode on March 2 and was saved by two Suffolk police officers, said she is awaiting a hospital report before deciding whether to discuss her daughter's case in detail. "The nurses in the pediatric intensive care unit were phenomenal," she said. "However, what happened should never have happened."The health department said it is "reviewing all aspects on the care the child received, including allegations of medication overdose." Richard Poole said his son Tyler's heart stopped for unknown reasons June 26 after "simple in-and-out" surgery to remove his adenoids. Although his son suffered from Duchenne muscular dystrophy, he said all precautions appeared to have been taken to ensure his son's safety. "I pray that is the case," said Poole, who added he hoped his son's death would raise awareness of the genetic disease, especially through the nonprofit group Parent Project Muscular Dystrophy.Health department spokesman Robert Kenny said the hospital reported Amee's death to the department. The state's investigation into Tyler's death was prompted by an inquiry from a Newsday reporter, though the hospital reported it after that inquiry was made.The state investigates any "unexpected" deaths - those unanticipated given the patient's diagnosis - as well as medication or surgery errors, all of which hospitals are required to report to the state, Kenny said. Complaints can also trigger an investigation.He also said it was not unusual for a hospital to have two ongoing investigations."We never want to see it but it's not out of the ordinary," said Kenny, who said he could not predict when the investigations would be completed. In 2002, the health department cited Stony Brook for a number of deficiencies following the death of 6-day-old Gianni Vargas of Brentwood, who died after he was given 10 times the proper dose of potassium chloride. The health department found that the staff did not follow proper procedures to ensure dilution of the potassium chloride, that there was a lack of coordination among various departments, and that the pharmacy computer system was unable to detect dosing errors.The 504-bed Stony Brook facility, Suffolk's largest hospital, is the only one in the county to provide highly specialized or "tertiary" care. Although it would not discuss the details of the current cases, the hospital defended its "outstanding record of patient safety." It cited an overall mortality rate of 1.78 percent from January to April of this year, which it said is lower than a 2.3 percent rate from a consortium of university hospital centers it uses as a benchmark. "This success was achieved even while caring for the region's most acute patients," the hospital said in a statement. However, Yosef Dlugacz, senior vice president for quality management for North Shore-Long Island Jewish Health System, questioned whether overall mortality is "a quality indicator to be used as a benchmark in comparing one hospital's performance against another hospital's performance." Dlugacz, who is publishing a book on health care quality measurements next month, said he prefers comparing outcomes from a particular diagnosis or procedure. That's how most hospital report cards are compiled.The hospital also defended its efforts to ensure patient safety. "Stony Brook University Hospital has patient care quality and safety as its first priority and participates in Patient Safety Net, an online reporting system that makes it possible for anyone in the hospital to anonymously report a patient safety concern or issue," the hospital said in a statement.It is also participating in a nationwide program designed by Stanford University and in the Institute for Healthcare Improvement's 100,000 Lives Campaign to reduce avoidable patient deaths. "We exceeded our goal and have, using risk-adjustment methods, saved an estimated 130 lives over the past 18 months," the statement said.Cases of concernCiting two recent deaths, a senior Stony Brook University Hospital surgeon has raised questions about "patient safety" there. Following are some cases that have prompted state reviews.June 26, 2006: Tyler Poole, 7, of West Islip, died after routine adenoid surgery. Cause of death is unknown. May 13, 2006: Amee Martin, 1, of Mastic, died from an apparent overdose of /papaverineSeptember 2003: "Baby Doe" of Suffolk County died of heart illness following cardiac surgery.February 2002: Gianni Vargas, 6 days old, of Brentwood, died after he was given 10 times the dose of potassium chloride. August 1995: Petra Fiel, 8 days old, of Ronkonkoma, was given 10 times the correct dose of morphine. She recovered.Medication errors statewide, 20055 Resulted in permanent harm to patient10 Resulted in near-death situation11 Resulted in death of patientSTATE HEALTH DEPARTMENT
Doctor shares concerns over safety
BY RIDGELY OCHSNewsday Staff Writer
One of Stony Brook University Hospital's own high-ranking heart surgeons is going public with concerns for patient safety at the facility, following the deaths of two children there.The deaths, which have occurred within the last two months, "appear to raise serious concerns about the safety net for patient care at the hospital," said Dr. Irvin Krukenkamp, who is associate dean for cardiothoracic academic affairs and professor of surgery, physiology and biophysics.Krukenkamp received a $3.3-million settlement in September after he claimed the university retaliated when he voiced similar worries about the death of another child. A hospital spokeswoman declined this week to discuss the lawsuit, but in the settlement document university officials denied any "wrongful conduct or liability or violation of any federal, state or local statute ordinance or law ... whatsoever."The critique from Krukenkamp comes as the state Department of Health investigates the June 26 death of 7-year-old Tyler Poole of West Islip and the May 13 death of 1-year-old Amee Martin of Mastic.Krukenkamp's current concerns about the use of proper procedures to avoid medical mistakes were echoed in his lawsuit, which he filed against the university and the hospital in February 2004. At that time, Krukencamp was chief of cardiothoracic surgery and director of the hospital's Heart Center.The suit charged that hospital officials decided to "terminate" him because he raised red flags about the care of an infant - identified only as Baby Doe - who died of heart illness in September 2003, after surgery in the pediatric cardiac surgery program. Krukenkamp's lawsuit was not the first time that questions had been raised about the program. In 1999, the state health department began monitoring it after three of 38 babies who had surgery that year died. As recently as February, health department spokesman Robert Kenny said last week, the state cited the program for violations "related to their quality assurance program and ... cases in which complications arose for patients post-surgically.""If the hospital fails to take all appropriate steps to correct the violations, we will consider closure of the program," he added.The hospital defended the program, saying it "has achieved extremely successful outcomes over the past several years." "We received the Department of Health's report addressing areas of concern and have responded. They have accepted our plan to address the issues they raised, and should return in September for an official review," the hospital said in a recent statement. In September, Krukenkamp, 49, who came to Stony Brook from Harvard in 1997, received a $3,375,000 settlement from the university plus promotion to associate dean and the right to stay at the hospital until 2007 and continue his research for another year after that.Nevertheless, he said he is worried about speaking out."I am truly fearful of making any further public statements at this time," said Krukenkamp. "My ability to speak out on such matters of public concern has been clearly chilled by my experiences at the hospital during the last two years." In the lawsuit, Krukenkamp, who was head of the committee that oversees quality assurance for cardiothoracic surgery, said that he raised concerns about the care of Baby Doe. The infant had been operated on by a pediatric heart surgeon from New York-Presbyterian Hospital who has been traveling once a week to Stony Brook since April 2001. Baby Doe developed complications after the first surgery, needed a second surgery and died shortly thereafter, according to the suit.In a letter dated Sept. 19, 2003, to Bruce Schroffel, then chief executive of the hospital, Krukenkamp questioned whether there was adequate surgical backup. He noted that the pediatric heart surgeon was at the university only once a week and there were no other doctors at the hospital with adequate experience in the highly specialized field. He also questioned what he termed in the lawsuit "the inherent conflict of interest" of having the hospital's medical director, Dr. Thomas Biancaniello, also chief of pediatric cardiology, involved in a review of the Baby Doe case.Soon after Krukenkamp raised questions, he said in the suit, he found he was not told about cardiothoracic surgery meetings or meetings were scheduled when he was operating. In November, he was told he was no longer supervising the pediatric congenital heart program, according to the suit. He also learned, he said, that the hospital had gone to an executive search firm to look for candidates to replace him. In addition, he said in the suit, the hospital's review process for Baby Doe "was being shut down."In early January, Krukenkamp met with university president Shirley Strum Kenny to voice his concern, he said in the suit. On Jan. 30, he met with Schroffel and Dr. Norman Edelman, who was then dean of the medical school and vice president of the Health Sciences Center. At the meeting, Krukenkamp said in the lawsuit, he was told that he should submit his resignation as chief of cardiothoracic surgery. Edelman told him that it was in "his best interest not to fight this," according to the suit.
http://www.newsday.com/news/local/longisland/ny-lihosp134815526jul13,0,558868.story
One of Stony Brook University Hospital's own high-ranking heart surgeons is going public with concerns for patient safety at the facility, following the deaths of two children there.The deaths, which have occurred within the last two months, "appear to raise serious concerns about the safety net for patient care at the hospital," said Dr. Irvin Krukenkamp, who is associate dean for cardiothoracic academic affairs and professor of surgery, physiology and biophysics.Krukenkamp received a $3.3-million settlement in September after he claimed the university retaliated when he voiced similar worries about the death of another child. A hospital spokeswoman declined this week to discuss the lawsuit, but in the settlement document university officials denied any "wrongful conduct or liability or violation of any federal, state or local statute ordinance or law ... whatsoever."The critique from Krukenkamp comes as the state Department of Health investigates the June 26 death of 7-year-old Tyler Poole of West Islip and the May 13 death of 1-year-old Amee Martin of Mastic.Krukenkamp's current concerns about the use of proper procedures to avoid medical mistakes were echoed in his lawsuit, which he filed against the university and the hospital in February 2004. At that time, Krukencamp was chief of cardiothoracic surgery and director of the hospital's Heart Center.The suit charged that hospital officials decided to "terminate" him because he raised red flags about the care of an infant - identified only as Baby Doe - who died of heart illness in September 2003, after surgery in the pediatric cardiac surgery program. Krukenkamp's lawsuit was not the first time that questions had been raised about the program. In 1999, the state health department began monitoring it after three of 38 babies who had surgery that year died. As recently as February, health department spokesman Robert Kenny said last week, the state cited the program for violations "related to their quality assurance program and ... cases in which complications arose for patients post-surgically.""If the hospital fails to take all appropriate steps to correct the violations, we will consider closure of the program," he added.The hospital defended the program, saying it "has achieved extremely successful outcomes over the past several years." "We received the Department of Health's report addressing areas of concern and have responded. They have accepted our plan to address the issues they raised, and should return in September for an official review," the hospital said in a recent statement. In September, Krukenkamp, 49, who came to Stony Brook from Harvard in 1997, received a $3,375,000 settlement from the university plus promotion to associate dean and the right to stay at the hospital until 2007 and continue his research for another year after that.Nevertheless, he said he is worried about speaking out."I am truly fearful of making any further public statements at this time," said Krukenkamp. "My ability to speak out on such matters of public concern has been clearly chilled by my experiences at the hospital during the last two years." In the lawsuit, Krukenkamp, who was head of the committee that oversees quality assurance for cardiothoracic surgery, said that he raised concerns about the care of Baby Doe. The infant had been operated on by a pediatric heart surgeon from New York-Presbyterian Hospital who has been traveling once a week to Stony Brook since April 2001. Baby Doe developed complications after the first surgery, needed a second surgery and died shortly thereafter, according to the suit.In a letter dated Sept. 19, 2003, to Bruce Schroffel, then chief executive of the hospital, Krukenkamp questioned whether there was adequate surgical backup. He noted that the pediatric heart surgeon was at the university only once a week and there were no other doctors at the hospital with adequate experience in the highly specialized field. He also questioned what he termed in the lawsuit "the inherent conflict of interest" of having the hospital's medical director, Dr. Thomas Biancaniello, also chief of pediatric cardiology, involved in a review of the Baby Doe case.Soon after Krukenkamp raised questions, he said in the suit, he found he was not told about cardiothoracic surgery meetings or meetings were scheduled when he was operating. In November, he was told he was no longer supervising the pediatric congenital heart program, according to the suit. He also learned, he said, that the hospital had gone to an executive search firm to look for candidates to replace him. In addition, he said in the suit, the hospital's review process for Baby Doe "was being shut down."In early January, Krukenkamp met with university president Shirley Strum Kenny to voice his concern, he said in the suit. On Jan. 30, he met with Schroffel and Dr. Norman Edelman, who was then dean of the medical school and vice president of the Health Sciences Center. At the meeting, Krukenkamp said in the lawsuit, he was told that he should submit his resignation as chief of cardiothoracic surgery. Edelman told him that it was in "his best interest not to fight this," according to the suit.
http://www.newsday.com/news/local/longisland/ny-lihosp134815526jul13,0,558868.story
Monday, July 03, 2006
Rise of Retail Clinics Giving Doctors a Chill
Chicago Tribune - June 12, 2006
Feeling threatened by the proliferation of retail health clinics staffed by nurse practitioners, the nation's largest doctors group is pushing this week for increased scrutiny of the clinics and the nurse practitioners who staff them. Read more...
Feeling threatened by the proliferation of retail health clinics staffed by nurse practitioners, the nation's largest doctors group is pushing this week for increased scrutiny of the clinics and the nurse practitioners who staff them. Read more...
The Doctor Will See You for Exactly Seven Minutes
New York Times - March 22, 2006
When politicians speak of America's health care needs, they often miss an important point: the doctor-patient relationship has become frayed. Patients aren't unhappy just because health care costs too much (though they would certainly like it to be more affordable). Read more...
When politicians speak of America's health care needs, they often miss an important point: the doctor-patient relationship has become frayed. Patients aren't unhappy just because health care costs too much (though they would certainly like it to be more affordable). Read more...
'Health Courts' Proposed to Fix Civil Malpractice System
The New Standard - June 27, 2006
John McCormack agrees with many that the medical malpractices ystem needs to be reformed. Just don't take away his right to a trial by jury. Read more...
John McCormack agrees with many that the medical malpractices ystem needs to be reformed. Just don't take away his right to a trial by jury. Read more...
Colo. Group Posts Hospital-Specific Mortality Rates
A Colorado coalition posted 2004 risk-adjusted mortality data for 11 common conditions and procedures. The hospital-specific data include volume, number of deaths, observed mortality rates, risk-adjusted mortality rates and whether there was a statistically significant difference from the statewide average. Read more...
Saturday, July 01, 2006
Charities Tied to Doctors Get Drug Industry Gifts
New York Times - June 28, 2006
As she presented research results indicating that a new medical device was "an important breakthrough," the doctor's enthusiasm was clear. Less evident were some of the financial links between the researchers and the device's maker. Read more...
As she presented research results indicating that a new medical device was "an important breakthrough," the doctor's enthusiasm was clear. Less evident were some of the financial links between the researchers and the device's maker. Read more...
Clinical Lab Quality
Clinical Labs: CMS and Organization Oversight Is Not Sufficient to EnsureLab Quality, by Leslie G. Aronovitz, director, health care, before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, House Committee on Government Reform. Read more...
27,000 Pacemakers & Defibr Could Be
Boston Scientific, which bought Guidant Corp. in April, says 27,000pacemakers and defibrillators made by the former Indianapolis-based companycould be faulty. Read more...
Parents, Doctors and the Disputed Link Between Vaccines and Autism
It has been nearly 50 years since mothers shouldered the blame for theirchildren's autism. Yet for many parents, echoes of that painful era remain. Read more...
MRSA Rising "Exponentially" Among Athletes, Students
Atlanta Journal-Constitution 06/18/06
A virulent bug that's resistant to the most common antibiotics is racingthrough high school and college athletic arenas and is rising"exponentially" among children, scientists say.
A virulent bug that's resistant to the most common antibiotics is racingthrough high school and college athletic arenas and is rising"exponentially" among children, scientists say.
Board Investigates Doc After 10 Of His Pts Die
June 24, 2006Ark. Probes Doctor After 10 Patients Die By THE ASSOCIATED PRESS
A state agency is investigating a physician after10 of his patients died from lethal mixtures of drugs or overdoses ofprescription medicines. Read more...
A state agency is investigating a physician after10 of his patients died from lethal mixtures of drugs or overdoses ofprescription medicines. Read more...
Who Do You Trust? FDA? EPA? Pharma?
When it comes to minding our personal health, Rich Gimpelson, an OBGYN inSt. Louis advised: Wear your seat belts, don't smoke, drink and eat inmoderation, exercise daily, keep your guns locked when not in use, and mostimportant - inherit good genes. Read more...
Ciproflex Caused Hearing Loss
(CBS 11 News) DALLAS A Dallas woman checked into a local hospital for aroutine treatment and says a doctor's mistake left her with a permanentdisability. The surprise came when she tried to get help from lawyers, whotold her that because of Texas law there was nothing they could do. Read more...
Drug Errors Pervasive, Study.
WASHINGTON, June 22 (UPI) -- A new study at Johns Hopkins Children's Centershows that errors occurred at all points in the medication process. But the authors added that careful monitoring could correct the problem. Read more...
Big Pharma Research Racket Is Killing People
June 23, 2006. By Evelyn Pringle
Over the past six years, ten FDA approved drugs have been withdrawn from themarket due to deaths and injuries, leading lawmakers to accuse the FDA ofnot doing its job in protecting the public from unsafe drugs and to call formeasures of improvement. Read more...
Over the past six years, ten FDA approved drugs have been withdrawn from themarket due to deaths and injuries, leading lawmakers to accuse the FDA ofnot doing its job in protecting the public from unsafe drugs and to call formeasures of improvement. Read more...
Judge Rules on Binding Arbitration Clause
Shannon P. DuffyThe Legal IntelligencerJune 22, 2006
An arbitration clause is "substantively unconscionable" and thereforeunenforceable under Pennsylvania law if it puts a plaintiff at a "distinctdisadvantage" by restricting discovery depositions to expert witnesses, aPennsylvania federal judge has ruled. Read more...
An arbitration clause is "substantively unconscionable" and thereforeunenforceable under Pennsylvania law if it puts a plaintiff at a "distinctdisadvantage" by restricting discovery depositions to expert witnesses, aPennsylvania federal judge has ruled. Read more...
Enter Ambulance, Or ER & Become An Instant Guinea Pig
By Robert Davis, Gannett News Service
As Hilary Williams hung from her seatbelt in the overturned wreckage of hertruck - legs broken, colon ruptured and lung bruised - blood oozed from torn arteries and veins. Read more...
As Hilary Williams hung from her seatbelt in the overturned wreckage of hertruck - legs broken, colon ruptured and lung bruised - blood oozed from torn arteries and veins. Read more...
Nonprofit Health Care Often Better, Study Says
By Kim Dixon - Reuters Tuesday, June 20, 2006; 2:01 PM
CHICAGO (Reuters) - For-profit nursing homes and hospitals on average provide an inferior quality of care compared with their nonprofit peers, according to an extensive review of studies published on Tuesday found. Read more...
CHICAGO (Reuters) - For-profit nursing homes and hospitals on average provide an inferior quality of care compared with their nonprofit peers, according to an extensive review of studies published on Tuesday found. Read more...
Profits, Executive Pay up at Malpractice Insurer.
By Michael Wagner Triangle Business JournalUpdated: 7:00 p.m. CT June 18, 2006
RALEIGH - Medical Mutual Insurance Co. of North Carolina, the state's largest medical malpractice insurer, saw profits climb 224 percent in fiscal2005 - a year in which top executives were granted hefty bonuses. Read more...
RALEIGH - Medical Mutual Insurance Co. of North Carolina, the state's largest medical malpractice insurer, saw profits climb 224 percent in fiscal2005 - a year in which top executives were granted hefty bonuses. Read more...
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