MEDICAL ERRORS, THE FDA, AND PROBLEMS WITH PRESCRIPTION DRUGS
Medical Errors - A Leading Cause of Death
The JOURNAL of the AMERICAN MEDICAL ASSOCIATION (JAMA) Vol 284, No 4, July 26th 2000 article written by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health, shows that medical errors may be the third leading cause of death in the United States.
The report apparently shows there are 2,000 deaths/year from unnecessary surgery; 7000 deaths/year from medication errors in hospitals; 20,000 deaths/year from other errors in hospitals; 80,000 deaths/year from infections in hospitals; 106,000 deaths/year from non-error, adverse effects of medications - these total up to 225,000 deaths per year in the US from iatrogenic causes which ranks these deaths as the # 3 killer. Iatrogenic is a term used when a patient dies as a direct result of treatments by a physician, whether it is from misdiagnosis of the ailment or from adverse drug reactions used to treat the illness. (drug reactions are the most common cause).
The National Academies website published an article titled "Preventing Death and Injury From Medical Errors Requires Dramatic, System-Wide Changes." which you can read online at http://www4.nationalacademies.org/news.nsf/isbn/0309068371?OpenDocument or the book "To Err Is Human: Building a Safer Health System" at http://www.nap.edu/books/0309068371/html/ - These show medical errors as a leading cause of death.
Based on the findings of one major study, medical errors kill some 44,000 people in U.S. hospitals each year. Another study puts the number much higher, at 98,000. Even using the lower estimate, more people die from medical mistakes each year than from highway accidents, breast cancer, or AIDS. And deaths from medication errors that take place both in and out of hospitals are aid to be more than 7,000 annually.
Prescription Drugs - Leading Killer in USA
According to information we have received, a statistical study of hospital deaths in the U.S. conducted at the University of Toronto revealed that pharmaceutical drugs kill more people every year than are killed in traffic accidents.
The study is said to show that more than two million American hospitalized patients suffered a serious adverse drug reaction (ADR) within the 12-month period of the study and, of these, over 100,000 died as a result. The researchers found that over 75 per cent of these ADRs were dose-dependent, which suggests they were due to the inherent toxicity of the drugs rather than to allergic reactions.
The data did not include fatal reactions caused by accidental overdoses or errors in administration of the drugs. If these had been included, it is estimated that another 100,000 deaths would be added to the total every year.
The researchers concluded that ADRs are now the fourth leading cause of death in the United States after heart disease, cancer, and stroke.
Source: Jason, et al. (Lazarou et al), Incidence of Adverse Drug Reactions in Hospitalized Patients, Journal of the American Medical Association (JAMA), Vol. 279. April 15, 1998, pp. 1200-05. Also Bates, David W., Drugs and Adverse Drug Reactions: How Worried Should We Be? JAMA, Vol. 279. April 15, 1998, pp. 1216-17.
One of the first JAMA article on medical errors appeared in JAMA 1994;272:1851-7. by Leape LL. Then in April 1998, JAMA 1998 Apr 15;279(15):1200-5 See http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9555760
Related articles are at http://jama.ama-assn.org/issues/v280n20/related/jlt1125-1.html#searchmedline
Other related articles:
Schuster M, McGlynn E, Brook R. How good is the quality of health care in the United States? Milbank Q. 1998;76:517-563. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9879302
World Health Report 2000. Available at: http://www.who.int/whr/2000/en/report.htm.
Starfield B. Evaluating the State Children's Health Insurance Program: critical considerations. Annu Rev Public Health. 2000;21:569-585. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10884965
Leape L. Unnecessary surgery. Annu Rev Public Health. 1992;13:363-383. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=1599594
Phillips D, Christenfeld N, Glynn L. Increase in US medication-error deaths between 1983 and 1993. Lancet. 1998;351:643-644. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9500322
Weingart SN, Wilson RM, Gibberd RW, Harrison B. Epidemiology and medical error. BMJ. 2000;320:774-777. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10720365
Guyer B, Hoyert D, Martin J, Ventura S, MacDorman M, Strobino D. Annual summary of vital statistics 1998. Pediatrics. 1999;104:1229-1246. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10585972
Harrold LR, Field TS, Gurwitz JH. Knowledge, patterns of care, and outcomes of care for generalists and specialists. J Gen Intern Med. 1999;14:499-511. http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10491236
Holland E, Degruy F. Drug-Induced Disorders - November 1, 1997 - American Family Physician "...more than 1 million patients are injured while in the hospital and approximately 180,000 die because of these injuries." http://www.aafp.org/afp/971101ap/holland.html
FDA advisers tied to industry
An article by Dennis Cauchon, the USA TODAY Newspaper
Sept. 25, 2000
According to a USA Today study, more than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed. The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.
The conflicts typically include stock ownership, consulting fees or research grants.
Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but according to the article, the FDA has waived the restriction more than 800 times since 1998.
These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.
The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.
A USA Today analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found:
At 92% of the meetings, at least one member had a financial conflict of interest.
At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.
At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.
"The best experts for the FDA are often the best experts to consult with industry," says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions. But Larry Sasich of Public Citizen, an advocacy group, says, "The industry has more influence on the process than people realize."
FDA Conflict-of-Interest continued:
In the book Alternative Medicine Definitive Guide to Cancer, they discuss "How Cancer Politics Have Kept You In the Dark" - Chapter 26. They talk about one study that disclosed that almost 50% of high-ranking FDA officials had been employed by major drug companies immediately before joining the FDA and that half of these officials upon leaving the FDA take up executive jobs in pharmaceutical companies.
Another study that they discuss was printed in the Wall Street Journal in 1992. It revealed that 60% of drug advertisements in medical journals actually violated FDA guidelines, yet the FDA did nothing about those violations.
Yet, in 1985, the FDA teamed up with the Pharmaceutical Advertising Council to use drug industry funds to combat "quackery" in medicine - alternative medicine.
Note: To get an understanding of why the FDA and other organizations are so opposed to "alternative medicine", be sure to read chapter 26 of the above named book - Alternative Medicine Definitive Guide to Cancer and other books, including the section of G. Edward Griffin's book World Without Cancer titled "The Politics of Cancer Therapy", or listen to the audio of the same name on our audio page.
System to Control Deadly Drug Interaction Failing
This article written by Andrea Knox for Knight Ridder Newspapers appeared on January 7, 2001 in "The Star," a Ventura County Newspaper.
In the article, it is reported that in the past four years, 10 prescription drugs and a vaccine have been taken off the market after killing and injuring thousands. According to the article, it is estimated that US drug fatalities runs 100,000 a year. There is no way of confirming the numbers because there is no reliable way to track and investigate problems with drugs. Doctors are not even required to report bad drug interactions.
It also doesn't help that the FDA has cut the time for routine drug approvals, making the real-life test for drugs coming after it has actually been approved. Without a proper monitoring system, it takes longer to discover what drugs could be causing problems.
Number of physicians in the U.S..........................................700,000
Accidental deaths caused by physicians per year................120,000
This information was sent to us indicating that it came from the Benton County News Tribune on the seventeenth of November, 1999