Benjamin Ofori, Driss Oraichi, Lucie Blais, Evelyne Rey, Anick Bérard ABSTRACT BACKGROUND: Many women take non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy but the risks for the infant remain controversial. We carried out a study to quantify the association between those women prescribed NSAIDs in early pregnancy and congenital anomalies. METHODS: A population-based pregnancy registry was built by linking data from three administrative databases in Quebec between 1997-2003. The inclusion criteria were mothers of live singleton infants, between 15-45 years of age, covered by the RAMQ drug plan 12 months before and during pregnancy, and prescribed an NSAID or other medications during pregnancy. We selected as cases infants with any congenital anomaly (ICD-9; 740-759) diagnosed in the first year of life. Up to 10 controls, defined as infants with no congenital anomalies detected were selected for each case. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were estimated. RESULTS: Within the registry, 36,387 pregnant women met the inclusion criteria. We identified 93 births with congenital anomalies in 1056 women (8.8%) who filled prescriptions for NSAIDs in the first trimester of pregnancy, compared to 2478 in 35,331 (7%) women who did not. The adjusted OR for any congenital anomalies for women who filled a prescription for NSAIDs in the first trimester was 2.21 (95% CI=1.72-2.85). The adjusted OR for the anomalies related to cardiac septal closure was 3.34 (95% CI=1.87-5.98). There were no significant associations with anomalies of other major organ systems. CONCLUSIONS: Our study suggests that women prescribed NSAIDs during early pregnancy may be at a greater risk of having children with congenital anomalies, specifically cardiac septal defects. Birth Defects Research (Part B), 2006. © 2006 Wiley-Liss, Inc. Benjamin Ofori 1, Driss Oraichi 1, Lucie Blais 2, Evelyne Rey 3, Anick Bérard 1Research Center, Sainte-Justine Hospital, Montreal, Quebec, Canada 2Faculty of Pharmacy, University of Montreal, Pavillon Jean-Coutu, Montreal, Quebec, Canada 3Faculty of Medicine, University of Montreal, Pavillon Roger-Gaudry, Montreal, Quebec, Canada

We may be taught not to judge a book by its cover, but when we see a new face, our brains decide whether a person is attractive and trustworthy within a tenth of a second, according to recent Princeton research. Princeton University psychologist Alex Todorov has found that people respond intuitively to faces so rapidly that our reasoning minds may not have time to influence the reaction -- and that our intuitions about attraction and trust are among those we form the fastest. "The link between facial features and character may be tenuous at best, but that doesn't stop our minds from sizing other people up at a glance," said Todorov, an assistant professor of psychology. "We decide very quickly whether a person possesses many of the traits we feel are important, such as likeability and competence, even though we have not exchanged a single word with them. It appears that we are hard-wired to draw these inferences in a fast, unreflective way." Todorov and co-author Janine Willis, a student researcher who graduated from Princeton in 2005, used timed experiments and found that snap judgments on character are often formed with insufficient time for rational thought. They published their research in the July issue of the journal Psychological Science. The study formed part of Willis' senior thesis work, which was inspired by an earlier paper by Todorov investigating the outcome of a political campaign. "I had done studies with my students that found there was a direct correlation between how competent a campaigning politician's face was and how great his margin of victory turned out in the final election," Todorov said of his earlier work, published in the journal Science last year. "We might assume that our judgments are founded on deliberate and rational thought processes, but observers had made their judgments about politicians based on a one-second look at their faces. I mentioned the findings to Janine, who suggested we look into just how fast we form these (judgments about) character traits." For the current study, the two researchers conducted several experiments on about 200 people. For one experiment, the researchers asked observers to look at 66 different faces for one of three time durations: either 100 milliseconds, 500 milliseconds or a full second. After each face flashed on the screen and vanished, the observers marked whether they found the face to be trustworthy or not, and also how confident they were in their analysis. Other experiments conducted in similar fashion tested for different specific traits, such as likeability and competence. "What we found was that, if given more time, people's fundamental judgment about faces did not change," Todorov said. "Observers simply became more confident in their judgments as the duration lengthened." Why the brain makes such snap judgments is not yet entirely clear, Todorov said. However, he often works with a sophisticated technological tool for probing brain activity called a functional magnetic resonance imager (fMRI), and Todorov said some of his general research suggests that the part of the brain that responds directly to fear may be involved in judgments of trustworthiness. "The fear response involves the amygdala, a part of the brain that existed in animals for millions of years before the development of the prefrontal cortex, where rational thoughts come from," he said. "We imagine trust to be a rather sophisticated response, but our observations indicate that trust might be a case of a high-level judgment being made by a low-level brain structure. Perhaps the signal bypasses the cortex altogether." The research, Todorov said, explores some of the same topics addressed in "Blink," the recent best-selling book by New York journalist Malcolm Gladwell about the rapid cognition our minds experience when making decisions quickly, especially those based on first impressions made in the "blink" of an eye. Gladwell, who is often described as a type of popular sociologist, has said the impetus for his book was the rapid judgments people made about him because of his long hair. "This paper's results concern specific mechanisms in the mind, while 'Blink' makes broader generalizations," Todorov said. "Gladwell's basic message is not essentially different from ours, though he views snap judgments to be primarily rational in nature. Our research finds that this is often the case, but not always." Todorov cautioned that his findings do not imply, however, that quick first impressions cannot be overcome by the rational mind. "As time passes and you get to know people, you, of course, develop a more rounded conception of them," he said. "But because we make these judgments without conscious thought, we should be aware of what is happening when we look at a person's face." What aspects of a face inspire such judgments remain undetermined, Todorov said. "We still don't know the physical features of a face that lead to a particular trait inference," he said. "We know generally what makes a face attractive, such as its symmetry, the proportions of its parts and the like. But what is it about a face that makes you think its owner is an essentially competent person? That's the subject of another study, one that needs to be done." This research was sponsored in part by the National Science Foundation. Abstract First Impressions: Making Up Your Mind After a 100-Ms Exposure to a Face Janine Willis and Alexander Todorov, Princeton University People often draw trait inferences from the facial appearance of other people. We investigated the minimal conditions under which people make such inferences. In five experiments, each focusing on a specific trait judgment, we manipulated the exposure time of unfamiliar faces. Judgments made after a 100-ms exposure correlated highly with judgments made in the absence of time constraints, suggesting that this exposure time was sufficient for participants to form an impression. In fact, for all judgments — attractiveness, likeability, trustworthiness, competence, and aggressiveness—increased exposure time did not significantly increase the correlations. When exposure time increased from 100 to 500 ms, participants’ judgments became more negative, response times for judgments decreased, and confidence in judgments increased. When exposure time increased from 500 to 1,000 ms, trait judgments and response times did not change significantly (with one exception), but confidence increased for some of the judgments; this result suggests that additional time may simply boost confidence in judgments. However, increased exposure time led to more differentiated person impressions.

Alumni of the former Eisenhower College returned to Seneca Falls August 4-6 to celebrate their annual homecoming weekend at New York Chiropractic College, once home to Eisenhower College. This year’s event marked the 30th anniversary of the Class of 1976 and the 25th anniversary of the Class of 1981. Though held in the dead of summer, celebrations included a “New Year’s Eve Party,” in keeping with the long-standing November tradition at Eisenhower College. On Saturday, alumni enjoyed a picnic lunch and presentation of Eisenhower College Alumni Association (ECAA) scholarship awards to Mynderse Academy students Jonathan R. Young and Matthew B. Quinn. ECAA Archivist Virginia “Gigi” Carnes lectured on the Eisenhower archival collection’s history and the alumni association’s future goals for archiving presidential and college memorabilia currently on display in the New York Chiropractic College library. There was also a rededicated of Punkin Park, a grassy expanse named for Joseph Andrew “Punkin” Campbell. The son of Eisenhower College philosophy professor James Campbell and his wife, Mary Ann, Punkin lost his life in a tragic accident in 1973 at the age of 8. On Saturday, NYCC faculty and graduates currently serving in the New York Guard conducted a flag-raising ceremony to commemorate the 40th anniversary of President and Mrs. Dwight D. Eisenhower‘s gift of the campus flagpole, presented by their son John on December 12, 1966. The flag they raised was flown over the U.S. Capitol building on May 28 of this year to honor the 34th anniversary of the graduation of Eisenhower College’s charter class, and in honor of NYCC. Pam Havens, ECAA chair, expressed the organization’s wishes to “acknowledge our very special and unique bond to this area and to our hosts and friends at New York Chiropractic College.” The ECAA Legacy Award, presented this year to New York Chiropractic College, traditionally recognizes those who have made significant contributions to perpetuating the legacy of Eisenhower College, its world-studies education, or the ECAA itself. Drs. Frank Nicchi, president of NYCC, and Beth Donohue, NYCC’s liaison to Eisenhower’s alumni association, received the award on behalf of NYCC on two separate occasions. Donohue was lauded by the ECAA for having helped pave the way for collaboration between the former and current colleges, and was named as an “Honorary Alumnus” of Eisenhower College. A cocktail party, dinner and awards ceremony honored distinguished alumni and faculty and closed the homecoming events. According to Havens, the Eisenhower College Alumni Association has thrived for nearly 25 years and will continue to work to keep the unique memory of Eisenhower College alive.

On August 14, 2006, Governor Pataki announced a comprehensive plan designed to extend the time for employees and volunteers injured in the rescue, recovery and cleanup operations after the September 11, 2001, terrorist attacks on the World Trade Center to file a claim for workers' compensation benefits and to receive prompt access to medical benefits while their claims are being litigated. Although it has been almost five years since the tragic events of September 11th, many people who participated in the rescue, recovery and cleanup efforts may have hidden health issues or suffer serious, disabling medical conditions that developed more than two years after their participation which may entitle them to workers' compensation benefits. Workers' Compensation Law, Article 8-A As a key part of his plan, Governor Pataki signed into law Article 8-A of the Workers' Compensation Law (hereinafter "WCL"), which extends the time for employees and volunteers who participated in rescue, recovery and cleanup operations following the September 11, 2001 terrorist attacks on the World Trade Center to file claims for workers' compensation benefits, provided they register with the Board before August 14, 2007. (Chapter 446 of the Laws of 2006). In order to register, those employees and volunteers who participated in World Trade Center rescue, recovery and cleanup operations (hereinafter "WTC operations") must file with the Workers' Compensation Board (hereinafter "Board") a sworn statement, on Form WTC-12, listing the dates and locations of their participation in the rescue, recovery and cleanup efforts. The filing of the registration form (Form WTC-12) does NOT constitute the filing of a claim. The filing of the sworn statement does however extend the time to file a claim. With respect to claims that were previously filed and denied as untimely under WCL §18 or §28, upon the filing of the sworn statement the claim will be reopened by the Board to reconsider this claim. This new legislation is effective immediately and is deemed to have been in effect since September 11, 2001. It will apply retroactively. A number of key terms are defined in new Article 8-A. WCL §161 defines a "participant in World Trade Center rescue, recovery or cleanup operations" as any employee or volunteer, who between September 11, 2001 and September 12, 2002: (i) participated in the rescue, recovery or cleanup operations at the World Trade Center site; (ii) worked at the Fresh Kills Land Fill in New York City; (iii) worked at the New York City morgue or the temporary morgue on pier locations on the west side of Manhattan; or (iv) worked on the barges between the west side of Manhattan and the Fresh Kills Land Fill in New York City. The term "World Trade Center site" is defined as "anywhere below a line starting from the Hudson River and Canal Street; east on Canal Street to Pike Street; south on Pike Street to the East River; and extending to the lower tip of Manhattan." Finally, a "qualifying condition" means "any latent disease or condition resulting from a hazardous exposure during participation in" WTC operations. This legislation also modifies the employer notice requirements with regard to claims for "qualifying conditions" resulting from participation in WTC operations. Under the Workers' Compensation Law, a claimant is required to provide notice of a work-related injury to his or her employer "within thirty days after the accident causing such injury" WCL §18. However, pursuant to WCL §163, a claimant with a "qualifying condition" will have two years from the date of disablement or the date when he or she knew or should have known that the latent condition was causally related to his/her participation in WTC operations to provide notice to the employer who employed the participant at the time of his/her participation in the rescue, recovery or cleanup operations. In the case of a volunteer, the volunteer must provide notice to the Board within two years of the date of disablement or the date when he/she should have known that the latent condition was causally related to his/her participation in WTC operations. Article 8-A applies to all pending and future claims filed or to be filed by participants in the World Trade Center rescue, recovery and cleanup operations, including those claims already disallowed because timely notice was not given to the employer (WCL §18) or the claim was not timely filed with the Board (WCL §28). WCL §165 expressly provides that claims previously brought by employees and volunteers who participated in WTC operations, which claims were disallowed based on the claimant's failure to provide timely notice to the employer or to file a timely claim for benefits, will be reopened and redetermined in accordance with the provisions of WCL Article 8-A, provided the claimant files a sworn statement with the Board before August 14, 2007. WCL §166 makes clear that claims brought by employees who participated in WTC operations in the course of their employment will be the liability of the insurance carrier on the risk for the employer on the date that the employee last participated in WTC operations, which is considered the date of accident. With respect to claims by volunteers, WCL §167 provides that benefits will be payable out of federal funds appropriated to the Board for that purpose. However, the uninsured employers' fund shall be deemed to be the employer only for the purposes of administering and paying claims for which it will be reimbursed from federal funds. Benefits to volunteers are payable to the extent that federal funds are appropriated and available for that purpose. Employees and volunteers who participated in rescue, recovery and/or clean-up operations at the World Trade Center site, the Fresh Kills Landfill, the New York City morgue or temporary morgue or the barges between the west side of Manhattan and the Fresh Kills Landfill between September 11, 2001 and September 12, 2002, who were exposed to hazardous conditions must file the registration statement, Board Form WTC-12, before August 14, 2007, in order for the provisions of Article 8-A to apply. Employees and volunteers who do not file the registration statement before August 14, 2007, will not have the benefit of the statute of limitations and notice provisions in Article 8-A. Instead, such claims will be governed by the provisions of WCL §18 and §28, which require notice to the employer within 30 days of the accident and the filing of a claim within two years. Payment Without Prejudice WCL §21-a allows an employer or its insurance carrier to pay workers' compensation lost wage and medical benefits to an injured employee for up to one year without admitting liability for the claim and without prejudice to its right to controvert the claim. At any time during that one-year period, the employer or carrier may provide notice that it is ceasing temporary payments and may then controvert the claim if its investigation reveals that it should not be liable. Rather than automatically controverting the claim, self-insured employers and workers' compensation insurance carriers are encouraged to voluntarily pay lost wage and medical benefits pursuant to WCL §21-a in those claims in which liability is uncertain and more time is needed to investigate the claim. Doing so will provide benefits to injured claimants, while preserving the right of an employer or carrier to later controvert a claim based on the results of its investigation. The employer or carrier is required to provide notice to the claimant and the Board that payments without prejudice have begun by filing Form C-669. Termination of temporary payments by the employer or carrier must be in accordance with the five day notice provisions of WCL §21-a (3). Temporary Payment from Volunteer Fund In claims arising out of employee participation in World Trade Center operations which are controverted by the self-insured employer or insurance carrier, the Board, in the interest of justice, has directed the World Trade Center Volunteer Fund to temporarily pay for a claimant's causally related medical treatment, until liability for the claim is ultimately determined. The World Trade Center Volunteer Fund is the money appropriated by the federal government to the Uninsured Employers' Fund (hereinafter UEF) for claims of volunteers. If claimant's employer or its insurance carrier is ultimately determined to be liable for the claim, the employer or carrier will reimburse the UEF for the cost of medical treatment paid while the claim was being litigated upon demand therefore. Any notice of decision containing a finding that the employer or its carrier is liable to pay the claim will include a direction to the employer or carrier to reimburse the UEF for amounts paid from the World Trade Center Volunteer Fund within thirty days from presentation of a demand by the UEF for reimbursement. Self-insured employers and insurance carriers who have controverted claims by employees for injuries or illnesses caused by participation in WTC operations, which have not yet been established, are directed to submit to the Board within 15 days of the date of this Announcement, and monthly thereafter, an itemized list of all medical bills to be paid from the World Trade Center Volunteer Fund detailing the date of treatment, name and address of the medical provider, diagnostic codes and the amount of the outstanding medical bill(s). The medical bills and the accompanying medical reports must be attached to the itemized list. Board Form WTC-16 MUST accompany each itemized list with attached medical bills and accompanying medical reports sent to the Board for payment initially and monthly thereafter. Health Providers must still request authorization from the self-insured employer or insurance carrier. The self-insured employers and carriers are directed to timely respond to all requests for authorization for special medical services pursuant to the procedures outlined in WCL 13-a(5) and 12 NYCRR 325-1.4(b). Health Providers must continue to forward medical bills to the insurance carrier of record. Reimbursement for pharmaceutical expenses will be accepted although reimbursement for claimants travel allowances will not be payable from this fund. Employer/Carrier Approval of Medical Treatment Medical providers are required by law to seek prior approval from the employer or its insurance carrier for any procedure costing more than $500. Sometimes the required approval cannot be obtained in a timely fashion. Recognizing this, the Board developed a procedure in 2002 to enable medical providers to request Board intervention whenever an employer or insurance carrier fails to promptly respond to a request for authorization, a procedure commonly referred to as the "MD-1 process". See WCB Subject Number 046-116, issued November 24, 2003. Employers and insurance carriers are urged in all cases, and particularly in those claims arising out of an employee or volunteer's participation in WTC operations following the September 11, 2001 attacks, to promptly respond to all requests for authorization of medical treatment. Additionally, medical providers are strongly encouraged to take advantage of the Board's MD-1 process when they do not receive a prompt response to a request for medical authorization. Donna Ferrara Chair

(Arlington, Va. - Aug. 16, 2006) Humana has agreed to a class action settlement resolving claims on behalf of chiropractors and other health care providers in Solomon v. Anthem, et. al., pending before Judge Frederico Moreno of the U.S. District Court for the Southern District of Florida. The ACA participated, through its counsel, in the settlement discussions and is a signatory to the proposed class action settlement agreement. If approved by the Court, Humana will pay $3.5 million to fund payments to class member chiropractors and other health care providers as well as fees and costs advanced by class counsel. Plaintiffs in the Solomon action recently filed a motion seeking to add the ACA as a named plaintiff in the Solomon case and requesting that ACN Group, Inc. and United Healthcare Services, Inc. be added as defendants. The case against ACN, United Healthcare Services and all remaining defendants is still pending. In addition to the cash fund described above, terms of the proposed settlement agreement with Humana include: • Changes in Humana’s business practices, intended to make its claims editing process more transparent and reduce confusion and disagreement over payments. • Online information provided by Humana to help providers understand its payment decisions. • More options for chiropractors and other health care providers to challenge Humana payment decisions in the future, if necessary. • Independent external reviews to resolve billing disputes. • The appointment of an ACA representative to a newly formed Humana health care provider advisory committee, which will provide a means of direct communication on issues and concerns. “We are extremely pleased that Humana has agreed to compensate chiropractors and other non-MD providers for claims that were previously and wrongly denied,” commented ACA President Richard Brassard, DC. “More importantly, however, we are heartened that Humana has committed to improving its business practices in the future and are hopeful that other networks and insurance companies will follow suit. Doing so can only benefit the nation’s health care consumers, who also deserve fair treatment and reimbursement.” As part of the settlement, doctors of chiropractic will be permitted to assign their portion of the recovery to the ACA, if they wish to do so. For a copy of the settlement agreement, click on the link below.

Patients in New York who need physical therapist services can now go directly to their physical therapist without having to wait to receive a referral from a physician. New York is the 43rd state to pass "direct access" legislation that eliminates, under certain conditions, the physician referral requirement for patients needing physical therapist services. The Consumer Access to Physical Therapy bill, S3169/A5622, passed the legislature with bipartisan support and was signed into law late yesterday by Governor George E Pataki. It will become effective in 120 days. This new law will allow patients to directly access the services of a licensed physical therapist for ten visits or thirty days, whichever comes first. "Physical therapists have been working with the state legislature to achieve direct access for patients for nearly 25 years. Now patients in New York, like patients in many other states, will have improved access to physical therapy care. This bill is a thoughtful piece of legislation with patient safety taking the highest priority," said James Dunleavy, PT, MS, president of the New York Physical Therapy Association (NYPTA). "The American Physical Therapy Association (APTA) applauds the state legislature for passing this important legislation to provide patients with direct access to physical therapist services," said APTA President R Scott Ward, PT, PhD. "Direct access helps to remove unnecessary barriers to healthcare and gives consumers a choice in accessing physical therapist services. Many states have had direct access laws on the books for nearly 30 years and evidence has shown that direct access to physical therapist services is cost-effective, safe and has improved access to care. Now residents of New York will be able to benefit from the same access to quality physical therapy services." The New York Physical Therapy Association (NYPTA) is a non-profit professional association of approximately 5,000 physical therapists, physical therapist assistants and students. The NYPTA is dedicated to serving the public's health interests, improving the standard of health for people of all ages and advancing the benefits of physical therapy and the interests of physical therapy professionals in the state of New York. The American Physical Therapy Association is a national professional organization representing more than 66,000 members. Its goal is to foster advancements in physical therapy practice, research, and education. For more information visit The New York Physical Therapy Association (NYPTA) by clicking on the link:

As Many as 540,000 New Yorkers were at risk for identity theft after a security breach was detected. Claimants of NYS Special Funds, a workers compensation carrier, recently received letters describing the possible theft of a personal computer, which contained their private information. However, it was reported today that the computer has been located and is secure. FBI is "reasonably certain" the information was not misused Read the story by clicking on the link:

The New York Road Runners this year initiated a new race the NYC Half Marathon which will go from Central Park to Battery Park. This race in the past has been only in Central Park. For its initial year this race was limited to ten thousand runners and it took only 5 minutes to "sell out." Dr. Stephen Perle who is the chiropractic coordinator for the ING NYC Marathon is asking for your support by volunteering to be a part of the medical team. He says that this is a good opportunity to "get ones feet wet" at a "smaller" race before volunteering for the ING NYC Marathon. There is no obligation to volunteer for this race in order to volunteer for the ING NYC Marathon or visa versa. Volunteers will be providing first aid only to runners. So no need to bring any equipment. There will be shirts and possibly hats supplied to all medical staff volunteers from Nike. Unlike the ING NYC Marathon there is no obligatory orientation. Volunteers will need to show up around 6 am and should be done around 10:30 Please see the race web site for more information about the race in general - New York Road Runners Club. If you are interested or have more specific questions about being a volunteer on the medical team, please contact Dr. Perle via email [email protected] Please keep your eyes on NYSCA's web site for information about volunteering at the ING NYC Marathon which will be November 5th. Keep that date open we would love to see hundreds of chiropractors volunteering.

WASHINGTON -- Medication errors are among the most common medical errors, harming at least 1.5 million people every year, says a new report from the Institute of Medicine of the National Academies. The extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs, the report says. The committee that wrote the report recommended a series of actions for patients, health care organizations, government agencies, and pharmaceutical companies. The recommendations include steps to increase communication and improve interactions between health care professionals and patients, as well as steps patients should take to protect themselves. The report also recommends the creation of new, consumer-friendly information resources through which patients can obtain objective, easy-to-understand drug information. In addition, it calls for all prescriptions to be written electronically by 2010 and suggests ways to improve the naming, labeling, and packaging of drugs to reduce confusion and prevent errors. "The frequency of medication errors and preventable adverse drug events is cause for serious concern," said committee co-chair Linda R. Cronenwett, dean and professor, School of Nursing, University of North Carolina, Chapel Hill. "We need a comprehensive approach to reducing these errors that involves not just health care organizations and federal agencies, but the industry and consumers as well," she said. Co-chair J. Lyle Bootman, dean and professor, College of Pharmacy, University of Arizona, Tucson, added, "Our recommendations boil down to ensuring that consumers are fully informed about how to take medications safely and achieve the desired results, and that health care providers have the tools and data necessary to prescribe, dispense, and administer drugs as safely as possible and to monitor for problems. The ultimate goal is to achieve the best care and outcomes for patients each time they take a medication." Estimates of Rates and Costs Medication errors encompass all mistakes involving prescription drugs, over-the-counter products, vitamins, minerals, or herbal supplements. Errors are common at every stage, from prescription and administration of a drug to monitoring of the patient's response, the committee found. It estimated that on average, there is at least one medication error per hospital patient per day, although error rates vary widely across facilities. Not all errors lead to injury or death, but the number of preventable injuries that do occur -- the committee estimated at least 1.5 million each year -- is sobering, the report says. Studies indicate that 400,000 preventable drug-related injuries occur each year in hospitals. Another 800,000 occur in long-term care settings, and roughly 530,000 occur just among Medicare recipients in outpatient clinics. The committee noted that these are likely underestimates. There is insufficient data to determine accurately all the costs associated with medication errors. The conservative estimate of 400,000 preventable drug-related injuries in hospitals will result in at least $3.5 billion in extra medical costs this year, the committee calculated. A study of outpatient clinics found that medication-related injuries there resulted in roughly $887 million in extra medical costs in 2000 -- and the study looked only at injuries experienced by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs. Improving the Patient-Provider Partnership Establishing and maintaining strong partnerships between health care providers and patients is crucial to reducing medication errors, the report says. The committee called on consumers to be active partners in their medication care and on physicians, nurses, and pharmacists to know and act on patients' medical care rights. The report recommends specific steps that physicians, nurses, pharmacists, and other health professionals should take to ensure that their patients are fully informed about their drug regimens and to minimize opportunities for mistakes to occur. Health care organizations also should make it a standard procedure to inform patients about clinically significant medication errors made in their care, whether the mistakes lead to harm or not. Currently, health care providers typically do not inform the patient or the patient's guardians about errors unless injury or death results. The report also provides consumers with a list of specific questions to ask health care providers, such as how to take their medications properly and what to do if side effects occur. Also included are actions consumers should take, such as requesting that their providers give them a printed record of the drugs they have been prescribed. Patients should maintain an up-to-date list of all medications they use -- including over-the-counter products and dietary supplements -- and share it with all their health care providers. This list should also note the reasons they are taking each product and any drug and food allergies they have. New and Improved Drug Information Resources Although consumers can find helpful drug information online or in the printed materials provided by pharmacies, this information often is too difficult for many people to understand, too scattered, or otherwise not consumer-friendly. The quality of the drug information leaflets that accompany prescriptions varies widely, and these printouts are typically written at a college reading level. The U.S. Food and Drug Administration (FDA) should work with other appropriate groups to standardize the text and design of medication leaflets to ensure that they are comprehensible and useful to all consumers. The committee called on the National Library of Medicine (NLM) to be the chief agency responsible for online health resources for consumers; it should create a Web site to serve as a centralized source of comprehensive, objective, and easy-to-understand information about drugs for consumers. In addition, NLM should work with other groups to evaluate online health information and designate Web sites that provide reliable information. The committee also recommended that NLM, FDA, and the Centers for Medicare and Medicaid Services evaluate ways to build and fund a national network of telephone helplines to assist people who may not be able to access or understand printed medication information because of illiteracy, language barriers, or other obstacles. This telephone network should also enable consumers to report medication-related mistakes or problems. Electronic Prescribing and Other IT Solutions New computerized systems for prescribing drugs and other applications of information technology show promise for reducing the number of drug-related mistakes, the report says. Studies indicate that paper-based prescribing is associated with high error rates. Electronic prescribing is safer because it eliminates problems with handwriting legibility and, when combined with decision-support tools, automatically alerts prescribers to possible interactions, allergies, and other potential problems, the committee found. While it acknowledged that significant regulatory issues and problems with automated alerts still need to be worked out, the committee said that by 2008 all health care providers should have plans in place to write prescriptions electronically. By 2010 all providers should be using e-prescribing systems and all pharmacies should be able to receive prescriptions electronically. The Agency for Healthcare Research and Quality (AHRQ) should take the lead in fostering improvements in IT systems used in ordering, administering, and monitoring drugs. All health care provider groups should be actively monitoring their progress in improving medication safety, the committee recommended. Monitoring efforts might include computer systems that detect medication-related problems and periodic audits of prescriptions filled in community pharmacies. Drug Naming, Labeling, and Packaging Confusion caused by similar drug names accounts for up to 25 percent of all errors reported to the Medication Error Reporting Program operated cooperatively by U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). In addition, labeling and packaging issues were cited as the cause of 33 percent of errors, including 30 percent of fatalities, reported to the program. Drug naming terms should be standardized as much as possible, and all companies should be required to use the standardized terms, the report urges. FDA, AHRQ, and the pharmaceutical industry should collaborate with USP, ISMP, and other appropriate organizations to develop a plan to address the problems associated with drug naming, labeling, and packaging by the end of 2007. The report also recommends studies to evaluate the impact of free drug samples on overall medication safety. In general, there has been growing unease among health care providers and others about the way free samples are distributed and the resulting lack of documentation of medication use, as well as the bypassing of drug-interaction checks and counseling that are integral parts of the standard prescription process. The study was sponsored by the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. A committee roster follows. INSTITUTE OF MEDICINE Board on Health Care Services Committee on Identifying and Preventing Medication Errors J. Lyle Bootman, Ph.D., Sc.D., (co-chair) Dean and Professor University of Arizona College of Pharmacy, and Founding and Executive Director University of Arizona Center for Health Outcomes and PharmacoEconomic Research Tucson Linda R. Cronenwett, R.N., Ph.D. (co-chair) Professor and Dean School of Nursing University of North Carolina Chapel Hill David W. Bates, M.D., M.Sc. Chief Division of General Medicine Brigham and Women’s Hospital; Medical Director of Clinical and Quality Analysis Partners Healthcare System; and Professor of Medicine Harvard Medical School Boston Robert M. Califf, M.D. Associate Vice Chancellor for Clinical Research; Director Duke Clinical Research Institute; and Professor of Medicine Division of Cardiology Duke University Medical Center Durham, N.C. H. Eric Cannon, Pharm.D. Director of Pharmacy Services and Health and Wellness IHC Health Plans Intermountain Health Care Salt Lake City Rebecca W. Chater, M.P.H. Director of Clinical Services Kerr Drug Inc. Asheville, N.C. Michael R. Cohen, Sc.D. President Institute for Safe Medication Practices Huntington Valley, Pa. James B. Conway, M.S. Senior Fellow Institute for Healthcare Improvement, and Senior Consultant Dana-Farber Cancer Institute Boston R. Scott Evans, Ph.D. Senior Medical Informaticist Department of Medical Informatics LDS Hospital and Intermountain Health Care, and Professor Department of Medical Informatics University of Utah Salt Lake City Elizabeth A. Flynn, Ph.D., R.Ph. Associate Research Professor Department of Pharmacy Care Systems Harrison School of Pharmacy Auburn University Auburn, Ala. Jerry H. Gurwitz, M.D. Chief Division of Geriatric Medicine; Dr. John Meyers Professor of Primary Care Medicine; and Executive Director Meyers Primary Care Institute University of Massachusetts Medical School Worcester Charles B. Inlander President People’s Medical Society Allentown, Pa. Kevin B. Johnson, M.D., M.S. Associate Professor and Vice Chair Department of Biomedical Informatics, and Associate Professor Department of Pediatrics Vanderbilt University Medical School Nashville, Tenn. Wilson D. Pace, M.D. Professor of Family Medicine and Green-Edelman Chair for Practice-based Research University of Colorado, and Director National Research Network American Academy of Family Physicians Aurora, Colo. Kathleen R. Stevens, Ed.D., R.N. Professor and Director Academic Center for Evidence-Based Practice University of Texas Health Science Center San Antonio Edward Westrick, M.D., Ph.D. Vice President of Medical Management University of Massachusetts Memorial Health Care Worcester Albert W. Wu, M.D. Professor of Health Policy and Management and Internal Medicine Johns Hopkins University Baltimore INSTITUTE STAFF Philip Aspden, Ph.D. Study Director Pre-publication copies of Preventing Medication Errors are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

New York Chiropractic College is proud to announce its upcoming commencement exercises scheduled to take place July 2006. On July 29 and 30, NYCC will confer graduate degrees upon candidates for Doctor of Chiropractic and Master of Science in Acupuncture or Acupuncture and Oriental Medicine, respectively. On Saturday, July 29 at 10:00 AM, 32 candidates for the degree of Doctor of Chiropractic will be awarded their diplomas in a ceremony to be held in the campus’ Delavan Theater. The commencement address will be delivered by Dr. Karen Erickson, NYCC Class of 1988 - the first chiropractor to be credentialed by a major teaching hospital in the United States. In 2000, Dr. Erickson was invited to join Beth Israel’s Continuum Center for Health and Healing in New York, where she currently serves on its faculty. A frequent speaker at conferences on chiropractic and integrative health care, Erickson has also authored two chapters on the subject. In 2003 Dr. Erickson graced the cover of New York Magazine in a piece entitled “Meet the New Super Chiropractors.” On Sunday, July 30 at 10:00 AM, the College will graduate its very first class from the NYCC School of Acupuncture and Oriental Medicine as 28 masters’ candidates take the stage. Marilee Murphy, the College’s Dean of Graduate Program in Acupuncture and Oriental Medicine, will read the candidates’ names and President Dr. Frank J. Nicchi, President, will hood the new graduates. Kevin V. Ergil, Director of the Graduate Program in Oriental Medicine and Associate Professor in the School of Health Sciences at Touro College, will deliver the commencement address. A practitioner of traditional Chinese medicine, Mr. Ergil is a practicing licensed acupuncturist (New York and California) and herbalist, having studied East Asian medicine since 1980. Mr. Ergil is a former director and current adviser for the Society for Acupuncture Research. In addition, he served as past president of the American College of Traditional Chinese Medicine in San Francisco and as founding dean of Pacific College of Oriental Medicine’s New York Campus. Ergil also served as Director of Research and as Chair of the Department of Acupuncture at the New York College for Holistic Health Education & Research (now the New York College for Health Professions), and as representative to the Council of Colleges of Acupuncture and Oriental Medicine from 1991 to 2000, where he chaired the Research Information and the Core Curriculum committee. NYCC President Nicchi expressed “extreme pride” that the College would soon graduate its first class of acupuncture and Oriental medicine professionals, and added, “I’m thrilled that we successfully achieved our goal to establish upstate New York’s first acupuncture and Oriental medicine masters program.” First consideration for the College’s expansion into the field of acupuncture and Oriental medicine occurred in 1995. Dr. Nicchi feels that the new AOM program is a perfect fit with the College’s chiropractic program, as acupuncture and chiropractic have long shared close ties. “Many chiropractors work with acupuncturists and refer patients to them,” he explained. Acupuncture is readily accepted by today’s public and has earned respect and acceptance within mainstream healthcare systems. Of the newly graduating AOM students, Dr. Nicchi commented, “They are about to enter a healthcare market that eagerly welcomes professionals skilled in the arts and science of Eastern medicine. Their career options are rife with opportunity.” For further information about New York Chiropractic College’s degree programs in Chiropractic and Acupuncture and Oriental Medicine, please visit our Web site at:

Rates of nausea and vomiting in pregnancy and dietary characteristics across populations Gillian V. Pepper and S. Craig Roberts Abstract: Nausea and vomiting in pregnancy (NVP) is a pervasive and debilitating phenomenon in humans. Several adaptive explanations for NVP occurrence have been recently proposed, the two most prominent of which predict associations with nutritional intake or specific dietary components. Here we extend previous cross-cultural analyses by analysing associations between NVP prevalence in 56 studies (21 countries) and quantitative estimates of per capita intake across major dietary categories, measured for the year of study by the Food and Agriculture Organisation (FAO). Rates of nausea and vomiting in pregnancy were correlated with high intake of macronutrients (kilocalories, protein, fat, carbohydrate), as well as sugars, stimulants, meat, milk and eggs, and with low intake of cereals and pulses. Restricting analyses to studies from North America and Europe caused relationships between macronutrient intake and NVP to disappear, suggesting that they might be influenced by non-dietary confounds associated with geographical region of study. However, factor analysis of dietary components revealed one factor significantly associated with NVP rate, which was characterized by low cereal consumption and high intake of sugars, oilcrops, alcohol and meat. The results provide further evidence for an association between diet and NVP prevalence across populations, and support for the idea that NVP serves an adaptive prophylactic function against potentially harmful foodstuffs. Gillian V. Pepper (AFF1) and S. Craig Roberts (AFF1) AFF1 School of Biological Sciences, University of Liverpool, Crown Street, Liverpool L69 7ZB, UK ISSN: 0962-8452 (Paper) 1471-2954 (Online) Issue: FirstCite Early Online Publishing DOI: 10.1098/rspb.2006.3633

Arlington, VA -- The American Chiropractic Association (ACA) continues to aggressively challenge the practices of ACN Group Inc. on multiple fronts and remains optimistic that the chiropractic profession can find relief from the managed care organization's tactics, despite an adverse ruling in a similar federal class action suit against UnitedHealthcare, a sister company of ACN. On June 19, a federal judge in Miami dismissed a national class action lawsuit brought against UnitedHealthcare and Coventry Health by 700,000 medical doctors who claimed the insurers had conspired to arbitrarily deny or reduce claims. U.S. District Judge Federico Moreno dismissed the lawsuit, known as the Shane case, due to "insufficient evidence" that the carriers conspired to deny claims in a coordinated manner. While the ACA is disappointed in this decision -- because the ruling could set a precedent and portend an adverse judgment in the Solomon case -- legal experts point out that the two cases are different and the possibility of prevailing still exists. In the Shane decision, Judge Moreno wrote that he did not condone the insurers’ practices, but he simply could not find enough evidence of a conspiracy after reviewing thousands of documents. According to ACA's legal team, the evidence ACA has compiled against ACN, which is not a party in the Shane case, is substantial and the court that made the decision in the Shane case has yet to review it. In addition, legal action is just one track in ACA's multi-pronged strategy against ACN. In addition to filing this national class action, ACA -- in cooperation with several state chiropractic associations -- is actively engaged with a number of state attorneys general, offices of insurance and boards of licensure, and the Federation of Chiropractic Licensing Boards (FCLB) regarding the tactics undertaken by ACN. According to ACA officials, these state attorneys general and state offices of insurance are reviewing the practices of ACN and other chiropractic managed care organizations and some are launching their own investigations. "The federal court's action is clearly disappointing,” said ACA President Richard Brassard, DC. “But I want to stress to the profession -- and especially to the doctors currently suffering under ACN policies -- that the ACA will exhaust every legal, administrative and political means to redress these problems. The ACA was created to fight for our patients and for chiropractic. We now have a fight of monumental proportions on our hands. We are confident we can prevail with the remedies available to us with the support of all in the profession." To augment ACA’s legal efforts, individual doctors of chiropractic and chiropractic state associations are being asked to take action by filing complaints with state regulatory agencies. In addition, doctors are encouraged to use ACA's ERISA pre-service template letters, found at www.ACAtoday.org/networks, to notify patients’ employers that the benefit they purchased for the employee is not accessible when medically necessary treatment is denied.

Norwalk, Iowa—The March 2006 issue of the Clinical Journal of Pain contains a systematic review of manual therapies research for the treatment of tension-type headache (TTH). After review of clinical and randomized controlled trials, published in English since 1994 and listed in MEDLINE, EMBASE, AMED, MANTIS, CINAHL, PEDro, and Cochrane databases, the researchers concluded that there is “no rigorous evidence that manual therapies have a positive effect in the evolution of TTH.” While these results are alarming, Anthony L. Rosner, Ph.D., LLD (Hon), Director of Research for the Foundation for Chiropractic Education and Research, admits that “regarding spinal manipulation, the most important aspect to carry away from this paper is that as a specific modality it may yet lack definitive supporting evidence in the management of tension-type headache.” The same is not true for cervicogenic headache (which this current study did not examine). For cervicogenic headache, there is high-quality evidence which suggests benefits specifically attributed to spinal manipulation. Dr. Rosner adds that “of all the healthcare providers able to distinguish between the types of headaches with an accurate diagnosis and then apply an appropriate therapy, it would appear that chiropractors more than any of the other alternatives are the best equipped to do so.” Even so, the chiropractic community must be aware that key areas of research are glaringly absent for the headaches and other conditions which they see on a regular basis. Such topics as the effects of the specific technique applied or its frequency and distribution over time are only now beginning to be addressed—and there is a long way to go. Outcome studies for pediatric headaches have yet to be published. The only way in which chiropractic is going to gain validation and reimbursement in these areas is through research, and it is through the support of FCER and its awarding of grants to deserving investigators within the chiropractic field that this goal can best be met. In the last 20 years alone, FCER—with the help of substantial financial input from NCMIC Insurance Company—has funded over $10 million in chiropractic research. Though every practicing D.C. has anecdotal, practice-based evidence supporting chiropractic efficacy for numerous conditions, that evidence will never be incorporated into systematic reviews. Quality published research is the only way that chiropractic will gain the respect it deserves in scientific circles. Please help chiropractic gain that respect today—join FCER. For more information on FCER, please go to www.fcer.org. FCER is a 501(c)(3) non-profit organization.

MEMORANDUM IN SUPPORT OF A.4527/S.3340: INSURANCE EQUALITY The NYSCA Legislative Committee has been working diligently with lobbyist Don Mazzullo in an effort to promote the Insurance Equality Bill to the New York State Senate and Assembly. Accordingly, Mr. Mazzullo has composed the attached position paper, designed to enlist backing for this important bill, which has been distributed to all New York State legislators. NYSCA encourages all of its members to review the attached memorandum, since passage of the Insurance Equality Technical Corrections Bill is of great importance to all Doctors of Chiropractic in New York State

Assemblyman Latimer, of the 91st District, a strong and outspoken proponent of Chiropractic attends NYSCA District 8 (Westchester) April 12 Meeting. The Assemblyman 91st District encompasses City of Rye, Town of Rye (Village of Port Chester, Rye Brook, and Mamaroneck), Town of Mamaroneck, Larchmont and part of New Rochelle. Assemblyman started his appearance before the NYSCA District 8 meeting with a comparison. "Political life is like being Elizabeth Taylor's seventh husband - you know what's expected of you but can you equal the performance?" District 8 President Dr. Janusz Richards stated that Assemblyman Latimer equaled the performance Wednesday night, with his most informative talk, giving all present very specific direction on how to best accomplish our legislative aims. "Get your story to the legislators - let them know what you do." Mr. Latimer distributed handouts of our insurance equality correction bill (A04527) and our workers compensation bill (A08340) both of which he is a co-sponsor. He has worked closely with us in the past. However, he admitted that Wednesday's meeting was a learning experience for him, i.e. NYS Business Council's history of opposition to chiropractic legislation and the reasons why. Although a freshman Assemblyman, who is running for re-election this November, he comes from a most accomplished background. Originally schooled and worked in the hotel industry he is married with one daughter. He is a former City of Rye Councilman, Past Chairman of the Westchester County Democratic Party, and Past Chairman of the Westchester County Board of Legislators. It was a most profitable evening for all those that attended. All came away with strong feelings of support for this true friend of the profession. Ms. Taylor would be proud of him!

The American Chiropractic Association (ACA) today asked the U.S. District Court in Miami to allow ACA to join as a plaintiff in the pending nationwide class action lawsuit Solomon v. Anthem, et al., and further asked that ACN Group, Inc. and United Healthcare Services, Inc. be named as additional defendants in the case. The ACA alleges that ACN participated with other managed care companies in the case in a conspiracy to illegally and systematically underpay providers by denying reimbursement for medically necessary treatment. ACA, along with other national and state health care associations, individual doctors of chiropractic and other health care providers, challenge the utilization review and payment practices of some of the nation’s largest managed care companies, including Health Net, Humana, PacifiCare Health Systems, Aetna, United Healthcare, Wellpoint Health Networks and Prudential. The case alleges that these companies, including ACN, violated the Racketeer Influenced and Corrupt Organizations (RICO) Act by systematically and illegally denying, delaying, and diminishing payments owed to chiropractors and other health care providers. Joining the ACA in its efforts against managed care companies, particularly ACN, is the Connecticut Chiropractic Association, who is also seeking to be named as a plaintiff in the litigation. The Florida Chiropractic Association is also a plaintiff. “There is simply no greater priority for ACA than to oppose what we view as the abusive tactics of ACN and other managed care organizations who systematically deny needed chiropractic care to our patients,” said ACA President Richard G. Brassard, DC. “Doctors from across the country have provided us with reports of intimidation and coercion conducted under the guise of utilization control. This can no longer be tolerated by a profession dedicated to quality patient care. The ACA intends to expend every effort and seek every possible legal remedy to put a halt to these harmful practices.” The suit calls into question the use of financially expedient cost and actuarial criteria rather than appropriate bases of medically necessary treatment for utilization review, and alleges that these criteria are purposely imposed on providers with the knowledge that they cannot be met. Through this legal action, ACA will seek damages against ACN and the other defendants in the case on a class-wide basis. It will also seek to obtain injunctive relief to bring an end to what it views as the abusive practices and procedures of ACN. “Our case involves protection of the doctor-patient relationship as to whether care will be provided on the basis of medical necessity, or based on what we believe are contrived policies and statistics skewed to maximize profits for managed care organizations such as ACN,” said ACA Chairman Lewis Bazakos, DC. Specifically, the complaint states the defendants, including ACN: -- Systematically refused to compensate health care providers for covered services; -- Processed health care providers’ claims using either automated programs which manipulate standard coding processes or use unqualified personnel to determine whether or not the service provided was medically necessary and covered; -- Downcoded and bundled legitimate claims to less costly procedures; -- Arbitrarily refused or reduced payment for certain categories of treatment; -- Systematically failed to recognize valid assignments of benefits; and, -- Delayed payments to health care providers by requesting additional documentation, even when such documents should not be required. The ACA’s overall campaign to correct the harmful practices of some managed care networks is an outgrowth of a resolution passed by the ACA House of Delegates in March 2002 formally outlining ACA’s opposition to the improper practices of chiropractic networks. “Doctors are being forced out of their practices daily by the abusive tactics of ACN and other managed care organizations. The ACA has listened to these doctors and other doctors practicing under the threat of unwarranted terminations,” Dr. Brassard said. “Like the generations of chiropractors before us, the ACA will not back away from its responsibility to protect the profession and the patients we serve. We ask the entire profession to unite with us in this effort, as the outcome will profoundly affect the way chiropractic care is provided now and in the future.” Actions at the State Level In addition to the filing of this national class action, ACA—in cooperation with several state chiropractic associations—is actively engaged with a number of state attorneys general, offices of insurance and boards of licensure, and the Federation of Chiropractic Licensing Boards (FCLB) regarding the tactics undertaken by ACN. To help augment the legal efforts underway by ACA, individual doctors of chiropractic and chiropractic state associations are being asked to take action by filing complaints with state regulatory agencies. Furthermore, doctors are encouraged to use ACA’s ERISA pre-service template letters, found at www.ACAtoday.org/networks, to notify a patient’s employer that the benefit they purchased for the employee is not accessible when medically necessary treatment is denied. To view copies of pleadings filed by ACA in the U.S. District Court in Miami, or for more information on ACA's managed care initiatives, visit ACA's Chiropractic Networks Action Center.

The Food and Drug Administration (FDA) announced the strengthening of its efforts against unapproved drug products. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children under 2 years of age. The agency is issuing a final guidance document outlining its approach to addressing other medicines that are marketed without FDA approval. The first action under the new guidance, "Marketed Unapproved Drugs--Compliance Policy Guide," concerns carbinoxamine-containing products. Carbinoxamine-containing products require FDA approval to be marketed, but numerous products containing carbinoxamine, either alone or in combination with other active ingredients, are marketed without FDA approval. To date, FDA has approved two carbinoxamine products for various allergic symptoms. Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, an indication for which carbinoxamine has not been found safe and effective by FDA. Many companies are selling carbinoxamine drops and syrups that are specifically labeled for use in children as young as one month of age. Carbinoxamine has never been studied in very young children, and FDA cannot predict how they will respond to it. However, children under 2 years of age are more susceptible to drug-related adverse events, in part due to the immaturity of their systems. FDA estimates that there are several hundred different unapproved active ingredients in prescription drugs on the market. The agency estimates that less than 2 percent of prescribed drugs are unapproved. "Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Acting FDA Commissioner Dr. Andrew von Eschenbach. "While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA approved. These unapproved drugs have bypassed the agency approval process through which FDA ensures, based on reliable scientific data, that marketed drugs are safe, effective, properly manufactured, and accurately labeled." Many of the unapproved drugs affected by today's final guidance, including the antihistamine carbinoxamine, are medicines that were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act. FDA approval guarantees that a product has been reviewed and will be consistently monitored for safety, effectiveness and adherence with manufacturing quality standards. "Unapproved drugs may not meet modern standards for safety, effectiveness, quality, and labeling. Clearly this is a problem we intend to fix," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. Health care providers are often unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs' labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians' Desk Reference (PDR). Under the guidance issued today, FDA is encouraging companies to comply with the drug approval process and seek approval for their products, as well as safeguarding consumer access to important medicines. The guidance identifies as the highest priority for agency enforcement action those unapproved products that are most likely to pose a risk to public health. The guidance explains that FDA intends to continue to give priority to enforcement actions involving unapproved drugs (1) with potential safety risks, (2) that lack evidence of effectiveness, and (3) that constitute health fraud. It also explains how the agency intends to address those situations in which a company obtains FDA approval to sell a drug that other companies have long been selling without FDA approval. Those manufacturers that do not comply with drug approval requirements may be subject to enforcement action. Today's actions are part of FDA's broader initiative, launched last year, to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs. The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling. It is noted that some unapproved drugs may provide benefits. However, since these unapproved drugs are not approved by the FDA, the agency recommends that patients and health care professionals carefully consider the medical condition being treated, the patient's previous response to the drug, and the availability of approved alternatives for treatment.

The Seneca Falls Health Center located on the campus of New York Chiropractic College is offering new services in an effort to better meet the needs of the community and to broaden its complementary healthcare therapies. The additions include mental health care, podiatry, and dyslexia correction. The center will continue to provide chiropractic care, internal medicine, massage therapy, acupuncture and oriental medicine. Terry Crane McDonald, Licensed Master Social Worker (LMSW) in the state or New York, recently began providing mental health care at the Seneca Falls Health Center (SFHC). Her practice provides individual, family and group therapy and covers such areas as marital and family issues; building healthy relationships; child and adolescent behavioral problems; ADD/ADHD; parenting; domestic abuse; alcohol and drug abuse and addiction, sexual identity; education and vocation; spirituality; anxiety and panic; depression; stress; grief; meditation, relaxation; self-esteem, assertiveness and empowerment; anger management; and obsessive/compulsive disorders. Terry says people often seek counseling when they feel “stuck.” Becoming more aware of who they are helps introduce a renewed power, freedom and happiness. Psychotherapy can help this effort. Ms. McDonald earned a bachelor’s in social work from Marycrest International University and her Master of Social Work from St. Ambrose University. She completed family development leadership training at Cornell University, and is a member of the National Association of Social Work. Drs. Carrie O’Neill, DPM, and Vicki Miller-Savard, DPM, of Complete Foot Care, also recently opened an office at the Health Center. They offer a wide range of podiatric care - specializing in foot surgery and the treatment of many common ailments such as fungal nails; in-grown toe nails; plantar warts; heel pain; bunions; hammer toes; and fallen arches. Foot care knows no age limits and both pediatric and senior patients are welcomed. The doctors, excited about their new centralized location, feel it will facilitate treatment of patients from Seneca Falls and the surrounding communities. Complete Foot Care has been located in the Finger Lakes region since 2004. They plan to continue hours at their Newark, NY, office and to maintain privileges with Geneva General, Newark and Clifton Springs hospitals. Dr. O’Neill is a graduate of Elmira College and Temple University and Dr. Miller-Savard is graduated from Cornell University and the Dr. William M. Scholl College of Podiatric Medicine. Both are members of the American and New York State Podiatric Medicine associations. The Seneca Falls Health Center now offers a dyslexia correction program implemented by Lisa Anderson, a certified Davis Dyslexia Correction® Facilitator, licensed with Davis Dyslexia Association International. She operates a learning center that focuses on the root causes of learning difficulties and uses the individual’s own strengths and talents to help overcome these difficulties. Her clients learn to recognize and correct disorientations; focus attention; eliminate confusion in words, symbols and numbers, and increase self confidence and ability in reading, writing, math and physical skills. The learning center provides individualized programs to help children and adults who experience difficulties in reading, writing, spelling, math, listening comprehension, ADD/ADHD, handwriting and motor coordination. Lisa says that early intervention is beneficial in improving academic performance in children, but as long as the client is motivated, it is never too late for help. She was inspired to become a Davis Facilitator after her son, a dyslexic, found success from the program. Ms. Anderson possesses a bachelor’s degree from the University of Rochester, earned her Master of Science in Education at SUNY Cortland and is a full time teacher at Mynderse Academy in Seneca Falls. To make an appointment or for more information about these or any of the health care services available at the Seneca Falls Health Center, please call the Center at 315-568-3166.

Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials Patricia M Kearney, Colin BaigentJon Godwin, Heather Halls, Jonathan R Emberson, Carlo Patrono Abstract Objective To assess the effects of selective cyclo-oxygenase-2 (COX 2) inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs) on the risk of vascular events. Design Meta-analysis of published and unpublished tabular data from randomised trials, with indirect estimation of the effects of traditional NSAIDs. Data sources Medline and Embase (January 1966 to April 2005); Food and Drug Administration records; and data on file from Novartis, Pfizer, and Merck. Review methods Eligible studies were randomised trials that included a comparison of a selective COX 2 inhibitor versus placebo or a selective COX 2 inhibitor versus a traditional NSAID, of at least four weeks' duration, with information on serious vascular events (defined as myocardial infarction, stroke, or vascular death). Individual investigators and manufacturers provided information on the number of patients randomised, numbers of vascular events, and the person time of follow-up for each randomised group. Results In placebo comparisons, allocation to a selective COX 2 inhibitor was associated with a 42% relative increase in the incidence of serious vascular events (1.2%/year v 0.9%/year; rate ratio 1.42, 95% confidence interval 1.13 to 1.78; P = 0.003), with no significant heterogeneity among the different selective COX 2 inhibitors. This was chiefly attributable to an increased risk of myocardial infarction (0.6%/year v 0.3%/year; 1.86, 1.33 to 2.59; P = 0.0003), with little apparent difference in other vascular outcomes. Among trials of at least one year's duration (mean 2.7 years), the rate ratio for vascular events was 1.45 (1.12 to 1.89; P = 0.005). Overall, the incidence of serious vascular events was similar between a selective COX 2 inhibitor and any traditional NSAID (1.0%/year v 0.9%/year; 1.16, 0.97 to 1.38; P = 0.1). However, statistical heterogeneity (P = 0.001) was found between trials of a selective COX 2 inhibitor versus naproxen (1.57, 1.21 to 2.03) and of a selective COX 2 inhibitor versus non-naproxen NSAIDs (0.88, 0.69 to 1.12). The summary rate ratio for vascular events, compared with placebo, was 0.92 (0.67 to 1.26) for naproxen, 1.51 (0.96 to 2.37) for ibuprofen, and 1.63 (1.12 to 2.37) for diclofenac. Conclusions Selective COX 2 inhibitors are associated with a moderate increase in the risk of vascular events, as are high dose regimens of ibuprofen and diclofenac, but high dose naproxen is not associated with such an excess. BMJ 2006;332:1302-1308 (3 June), doi:10.1136/bmj.332.7553.1302 Patricia M Kearney, clinical research fellow1, Colin Baigent, reader in clinical epidemiology1, Jon Godwin, research fellow1, Heather Halls, research assistant1, Jonathan R Emberson, senior statistician1, Carlo Patrono, professor of pharmacology2 1 Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford OX3 7LF, 2 Department of Pharmacology, University of Rome "La Sapienza," Rome, Italy

The Council on Chiropractic Guidelines and Practice Parameters (CCGPP) has released the long-awaited initial draft of their low back best-practice document. This draft will remain posted on this site in order to solicit responses for 60 days, from May 11, 2006 until July 10, 2006. After that date, this draft will be removed from this site and your comments will be compiled by our survey contractor. The lower back team will then examine the results obtained for any potential impact on the chapter, with changes being made as necessary. The following draft includes introductory chapter background information. This is followed with rationale and other information that will assist the reader in the examination of the document and which will provide insights into the process that our organization followed when constructing this document. The full text information on the lower back is next followed by tables, appropriate references and search strategies employed. We request that the reader examines the draft in its entirety in order to be able to arrive at informed conclusions concerning the content. CCGPP has focused on typical presentations seen in a chiropractic office in this document and the subject material of other chapters may be found elsewhere on this site. Since wellness care has always been a traditional and significant focus of chiropractic practice, this topic is both woven into individual chapter information as well a separate chapter which also addresses this component of care. At the conclusion of the draft document, the reader will be directed to a third-party survey site to answer a few questions and to also provide additional comments, if it is appropriate. The site is: www.surveymk.com. Again, if you are an interested consumer, patient, third-party payor representative, representative of a governmental agency or other interested stakeholder, you may instead visit www,Spine-Health.com in order to examine more abbreviated lower back draft summary information and to also offer comments. Comments and additional references provided by the reader potentially can alter the draft, so we request that contributors formulate responses carefully and accordingly.