David Olmos reports for the Bloomberg News (6/26) "Generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by US authorities, who cited violations of manufacturing standards." The company had received a warning letter in October 2008 after inspections in May and June found deficiencies. Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said inspectors who saw the facilities in May 2009 "found 'serious violations' of manufacturing standards and 'serious deficiencies' in quality control."
The FDA said drugs "and raw ingredients for pain, heart ailment, and psychiatric medications were confiscated today at three Caraco facilities in Michigan to prevent the Detroit-based company from distributing its products until the manufacturing deficiencies are corrected."
Jared Favole reports on other recent FDA activity for the Dow Jones Newswires (6/26) stating "painkillers such as Tylenol will go under a microscope... as federal regulators and medical experts debate how to limit liver injury in patients who take the medicines." At issue is acetaminophen, which is the most widely used drug in America. Approximately "100 people die annually from accidentally overdosing on acetaminophen,” and over 50,000 are temporarily hospitalized. The Food and Drug Administration says the drug is safe if taken at recommended levels, but “the drug's prevalence in a variety of pain relievers, fever reducers, and cough medicines means patients don't realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen."
According to Dow Jones, the FDA has been struggling with how best to control the issues surrounding acetaminophen since at least 1977, when an agency committee suggested labels for pain relievers contain a warning that they can damage a patient's liver. In April, the FDA mandated that over the counter drugs containing acetaminophen must have a label warning of liver injury. On Tuesday, the panel of experts voted to lower the maximum over the counter dosage and to ban drugs that combine narcotics and acetaminophen, including Vicodin and Percocet. Perhaps warning labels and other possible safety measures - including reducing recommended dosage levels, limiting the number of pills or liquid in each drug containing acetaminophen, and eliminating medicines that combine acetaminophen with other ingredients - could save many lives per year.
John Fauber reported for the Milwaukee Journal Sentinel (6/20), "At least 11 doctors with the University of Wisconsin School of Medicine and Public Health received more than $50,000 from drug or medical device companies last year, including seven who pulled in six-figure amounts." As a result, the university is requiring "doctors for the first time...to specify how much outside income they receive." According to "the disclosure forms...orthopedic surgeons, who command some of the highest salaries among university and state employees, also got some of the biggest outside income checks, mostly from companies that make medical devices."
Some of these surgeons "were among the most vocal opponents to the university's new disclosure requirements, referring to the more stringent disclosure requirements as voyeuristic." Meanwhile, "critics of these arrangements say they increase the cost of medicine, potentially compromise patient care, and damage the integrity of medical research." Physicians who work "for drug and device companies" have "come under scrutiny in recent years, including congressional investigations, medical journal articles and the media."
Liz Kowalczyk (6/23, The Boston Globe) reports, "Junior surgeons at Massachusetts General Hospital have been working too many hours, in violation of patient safety rules, according to a national accrediting organization that is threatening to put the hospital's surgery training program on probation."
The Accreditation Council for Graduate Medical Education "cited the hospital because a significant number of its surgeons in training, known as residents, were exceeding hour limits and working seven days straight. The organization believes these workloads contribute to fatigue-related mistakes, and has given the hospital until August 15 to fix the problem." The Institute of Medicine, which advises the U.S. government on health policy, "is pushing the council to limit residents' hours even further. It recently recommended that nap time be mandated for residents who work 30-hour overnight shifts."
The most difficult transition has been changing the “resident culture,” as residents do not like the hour restrictions because they feel as though it does not allow them to spend adequate time with patients and forces them to hand off their patients to other doctors mid procedure. However, a well rested physician is less likely to make an error due to fatigue than a physician who has been on call for 30 hours. Avoiding injuries is surely worth any inconveniences caused by the restrictions.
The New York Times (6/21, A1, Bogdanich) reports on the Philadelphia VA hospital, where "a rogue cancer unit...that operated with virtually no outside scrutiny...botched 92 of 116 cancer treatments over a span of more than six years -- and then kept quiet about it."
Dr. Gary D. Kao was responsible for all but a handful of the treatment mistakes. In treating Prostate cancer, small radioactive stones can be inserted into the body and placed near the prostate. In several instances, Dr. Kao was severely inaccurate with his placement of the stones. In one case, most of the 40 stones inserted ended up in the patient’s gall bladder. Dr. Kao then rewrote his surgical plan to cover up his mistake with permission from the institutional regulators. The patients were not informed of the mistakes in their treatment for several years until federal investigators uncovered the mistakes.
Negligence occurred not only on the part of the physician, but also on the part of the institution for knowingly allowing surgical revisions. Furthermore, “peer review, a staple of every good hospital, in which colleague’s examine one another’s work, did not exist in the unit.” Overall, the implant program lacked a “safety culture,” and the nuclear commission found that Dr. Kao and other members of his team were not properly supervised or trained.
The Indictment was sought by the United States attorney in Philadelphia and is one of the strongest actions against medical drug and device makers in years. Michael L. Levy, the United States attorney said, “they put their profits ahead of responsible business practices and the truth.”
In 2002, the FDA approved the bone filler only for general bone repair but regulators “insisted that Synthes not promote its use for spinal procedures.” Charges in the indictment allege that Synthes company officials went behind the FDA’s back and approached selected operators to perform unapproved operations with the understandings that “the company would help them publish their clinical results.”
Cautionary findings, including possible severe blood clotting caused by the use of the bone filler were not taken seriously by executives. The company was further accused of running unauthorized human trials of the bone filler in spinal procedures, which may have lead to three deaths. These deaths were not reported to the FDA.
Improper business relationships between doctors and medical device makers are a cause for concern. If a doctor has the incentive to use one device over another, then patients cannot be certain that they are receiving the best quality care. Incentives drive human behaviors, and as a Chicago medical malpractice lawyer, I feel strongly that such incentives should not influence the doctor-patient relationship.
Many believe that the practice of so called “defensive medicine” is the primary culprit for the high and rising health care costs. However, this assertion “is not supported by empirical data or academic literature.” Recent news reports, CBO and GAO analyses, and statements from administration officials have shown that “physicians will over-test and over-treat purely for financial reasons, unrelated to liability concerns.”
While the healthcare system is clearly in need of reform, patient saftey should not be sacrificed. Limiting the rights of victims of medical negligence would have a detrimental effect on the quality of health care. Lawmakers should seek to decrease the 98,000 deaths that occur each year as the result of medical negligence, and limiting the ability for victims to hold wrongdoers accountable will not accomplish this goal.
Hurley McKenna & Mertz filed the first Crestwood case in Illinois.
The complaint "outlines a systematic coverup of Crestwood's routine use of its tainted well and provides more details about actions first publicly revealed by the Tribune in April." Crestwood officials avoided scrutiny for over twenty years by misleading the state to believe that residents were getting only Lake Michigan water.
In late 2007, when EPA inspectors tested the water for the first time since 1986, they found the well was contaminated with dichloroethylene and vinyl chloride, which is so toxic the U.S. EPA says there is no safe level of exposure. The well was finally shut down in Late 2007, after exposing citizens to its harmful contaminants for over two decades.
Moreover, records show Crestwood officials knew the well was contaminated at least as early as 1986. They also heard about the pollution in 1998, when village officials tested the well and found dichloroethylene in the water. Both times, Crestwood officials managed to cover their tracks. The continuous irresponsible and clandestine actions by Crestwood are infuriating to all.
However, "a new report from an independent government watchdog group suggests that those claims are exaggerated." The study by the New York Public Interest Research Group found that "the amount of money paid for malpractice claims in New York has actually fallen in recent years, and that the number of overall claims has remained remarkably stable.” Tom Baker wrote in his book, The Medical Malpractice Myth (U. Chicago Press), that a “California study, as confirmed by more recent, better publicized studies” verifies “that the real problem is too much medical malpractice, not too much litigation.” He found that “most people do not sue, which means that victims—not doctors, hospitals, or liability insurance companies—bear the lion’s share of the costs of medical malpractice.”
Many public complaints about the medical malpractice “crisis” have been greatly exaggerated. Doctors who have not exercised due care with their patients should be liable for injuries their negligence caused. As a medical malpractice lawyer, I provide a service to those who have been injured by the negligence of medical care providers.
However, hip resurfacing is “typically more difficult to perform than replacing the total joint. In general, surgeons say, resurfacings can take longer and require bigger incisions than hip replacements.” (Wall Street Journal, 6/4) Moreover, women who receive the hip resurfacing procedure seem to be at a greater risk for failure. Researches found that “five years after surgery, 5.2% of women under 55 with a resurfacing had undergone a second, corrective operation.”
On the other hand, only “3.6% of women in that age group needed a second operation after getting a full hip replacement.” Corrective surgeries are necessary when resurfacing causes the “femoral neck – a piece of bone surgeons retain in resurfacing but replace in a full hip replacement” to fracture. Women can be at greater risk due to their generally smaller frames, and lower bone densities.
Many studies have been performed and others are currently underway. The most consistent results include the finding that the overall functional outcomes of hip resurfacings and hip replacements appear to be very similar. Only in the studies where participants get to choose the procedure do results show that those who receive hip resurfacings appear to be more active, which is likely reflective of the fact that they were more active originally.
In the United States last year, resurfacing accounted for no more than 3.5% of the 430,000 hip replacements that occurred, but the number of new resurfacing patients this year is expected to increase by 40 to 50 percent, according to the consulting firm Millennium Research Group (NYT).
When considering any surgical procedure it is important to discuss and consider all of the risks with your physician. If you have been injured because you were not informed of the risks associated with a surgical procedure, you should contact a medical malpractice lawyer to discuss your case.
The bill "would give the Food and Drug Administration (FDA) wide new powers to regulate tobacco products. It would levy user fees on tobacco products and create a new department within the FDA with the authority to regulate tobacco marketing and advertising, control the amount of nicotine in products, and bar such product claims as 'light' and 'low-tar.'" While "floor action on the bill could take up most of the week," the bill "is expected to eventually pass."
The AP (6/3, Abrams) reports that on Tuesday the Senate voted 84-11 to advance the regulatory legislation. Since only sixty votes were needed, "the success in reaching that threshold increases the likelihood that the Senate will move to a final vote by the end of the week. If the House concurs with the Senate measure, it would go to President Barack Obama, who is ready to sign it into law."
The Campaign for Tobacco Free Kids (5/21) reported “tobacco use is the number one cause of preventable death in America,” killing more than 400,000 Americans annually and costing the nation $96 billion in health care bills per annum. Every day, another “1,200 lives are lost due to tobacco consumption and over 1,000 kids become new regular smokers”.
Despite being the deadliest product sold in America, tobacco products are among the least regulated. They are “exempt from basic health regulations that apply to other consumer products,” which allows tobacco companies to employ deceptive marketing techniques to attract children to their “deadly and addictive” products, “deceive consumers about the harm their products cause, and resist changes that could make their products less harmful.” Therefore, Congress has the opportunity to protect thousands of lives by passing the regulatory legislation.
As a Chicago medical malpractice lawyer, that has represented too many lung cancer victims; I consider this legislation now working its way through the Senate welcome news.
The Illinois Appellate Court's decision also holds for the first time under Illinois law that the parents in a wrongful birth case may have a cause of action for negligent inflection of emotional distress against the tortfeasor physician and hospital. The child in this case has Angelman's Syndrome. The plaintiffs allege that a geneticist failed to obtain test results that confirmed that the parents were at high risk of conceiving children with this devastating disorder. Children with Angelman’s Syndrome have severe mental and emotional deficits due to a chromosomal defect, and require nearly constant care from their parents, yet are expected to reach normal adult size as they mature. In this case, because of their child’s disability, the plaintiff parents are subjected to regular physical trauma from the child due to head butting, biting, kicking, setting fires and other rough treatment. The Illinois Appellate Court found that the child's disabilities place the parents in a "zone of danger," and thus the child's parents can seek damages for their own pain and suffering in caring for the severely disabled child.
The plaintiffs are represented by Christopher T. Hurley, Mark R. McKenna and Evan Smola of Hurley McKenna & Mertz. The defendant Children’s Memorial Hospital is represented by Pam Gellen of Lowis & Gellen.
The case is Clark v. Children's Memorial Hospital, Illinois Appellate Court No. 1-08-0610.
Questions regarding wrongful birth cases, or requests for copies of the case or Complaint at Law can be directed to Christopher Hurley or Mark McKenna at 312/553-4900.
An article discussing Wrongful Birth and Wrongful Life cases can be found in the New York Times Magazine.
"The Joint Commission, the major accreditor of US hospitals...said it was investigating the incident," the Chicago Tribune (3/28, Japsen) noted. The hospital claimed that an investigation by the Illinois Department of Health on Feb. 18 "found proper policies and procedures were in place but that staff members may not have followed the protocol." But, the letter indicated that "the hospital failed to 'maintain a central emergency services log' and 'provide a medical screening exam.'"
]]>Facilitated communication (FC) has been widely adopted throughout North America in special/vocational education services for individuals with developmental disabilities who are nonverbal. A basic premise of facilitated communication is that people with autism and moderate and profound mental retardation have "undisclosed literacy" consistent with normal intellectual functioning. Peer reviewed, scientifically based studies have found that the typed language output (represented through computers, letter boards, etc.) attributed to the clients was directed or systematically determined by the paraprofessional/professional therapists who provided facilitated assistance (Bligh & Kupperman, 1993; Cabay, in press; Crews et al., in press; Eberlin, McConnachie, Ibel, & Volpe, 1993; Hudson, Melita, & Arnold, 1993; Klewe, 1993; Moore, Donovan, & Hudson, 1993; Moore, Donovan, Hudson, Dykstra, & Lawrence, 1993; Regal, Rooney, & Wandas, in press; Shane & Kearns, in press; Siegel, in press; Simon, Toll, & Whitehair, in press; Szempruch & Jacobson, 1993; Vasquez, in press; Wheeler, Jacobson, Paglieri, & Schwartz, 1993). Furthermore, it has not been scientifically demonstrated that the therapists are aware of their controlling influence.
Consequently, specific activities contribute immediate threats to the individual civil and human rights of the person with autism or severe mental retardation. These include use of facilitated communication as a basis for a) actions related to nonverbal accusations of abuse and mistreatment (by family members or other caregivers); b) actions related to nonverbal communications of personal preferences, self-reports about health, test and classroom performance, an family relations; c) client response in psychological assessment using standardized assessment procedures; and d) client-therapist communication in counseling or psychotherapy, taking therapeutic actions, or making differential treatment decisions. Instances are widely noted where use of facilitated communication in otherwise unsubstantiated allegations of abuse has led to psychological distress, alienation, or financial hardship of family members and caregivers. The experimental and unproved status of the technique does not preclude continued research on the utility of facilitated communication and related scientific issues. Judicious clinical practice involving use of facilitated communication should be preceded by the use of fully informed consent procedures, including communication of both potential risks and likelihood of benefit.
Facilitated communication is a process by which a facilitator supports the hand or arm of a communicatively impaired individual while using a keyboard or typing device. It has been claimed that this process enables persons with autism or mental retardation to communicate. Studies have repeatedly demonstrated that facilitated communication is not a scientifically valid technique for individuals with autism or mental retardation. In particular, information obtained via facilitated communication should not be used to confirm or deny allegations of abuse or to make diagnostic or treatment decisions.
THEREFORE, BE IT RESOLVED that APA adopts the position that facilitated communication is a controversial and unproved communicative procedure with no scientifically demonstrated support for its efficacy.
References:
(1) Bligh, S. & Kupperman, P. (1993). Evaluation procedure for determining the source of the communication in facilitated communication accepted in a court case. Journal of Autism and Developmental Disorders, 23, 553-557.
(2) Cabay, M. (in press). A controlled evaluation of facilitated communication with four autistic children. Journal of Autism and Developmental Disorders.
(3) Crewe, W. D., Sanders, E. C., Hensley, L. G., Johnson, Y. M., Bonaventura, S., & Rhodes, R. D. (in press). An evaluation of facilitated communication in a group of nonverbal individuals with mental retardation. Journal of Autism and Developmental Disorders.
(4) Eberlin, M., McConnachie, G., Ibel, S. & Volpe, L. (1993). Facilitated communication: A failure to replicate the phenomenon. Journal of Autism and Developmental Disorders, 23, 507-530.
(5) Hudson, A., Melita, B., & Arnold, N. (1993). Brief report: A case study assessing the validity of facilitated communication. Journal of Autism and Developmental Disorders, 23, 165-173.
(6) Klewe, L. (1993). An empirical evaluation of spelling boards as a means of communication for the multihandicapped. Journal of Autism and Developmental Disorders, 23, 559-566.
(7) Moore, S. Donovan, B., & Hudson, A. (1993). Facilitator-suggested conversational evaluation of facilitated communication. Journal of Autism and Developmental Disorders, 23, 541-551.
(8) Moore, S. Donovan, B., Hudson, A., Dykstra, J., & Lawrence, J. (1993). Evaluation of facilitated communication: Eight case studies. Journal of Autism and Developmental Disorders, 23, 531-539.
(9) Regal, R. A., Rooney, J. R., & Wandas, T. (in press). Facilitated communication: An experimental evaluation. Journal of Autism and Developmental Disorders.
(10) Shane, H. C., & Kearns, K. (in press). An examination of the role of the facilitator in "facilitated communicatio". American Journal of Speech-Language Pathology.
(11) Siegel, B. (in press). Assessing allegations of sexual molestation made through facilitated communication. Journal of Autism and Developmental Disorders.
(12) Simon, E. W., Toll, D. M., & Whitehair, P. M. (in press). A naturalistic approach to the validation of facilitated communication. Journal of Autism and Developmental Disorders.
(13) Szempruch, J., & Jacobson, J. W. (1993). Evaluating the facilitated communications of people with developmental disabilities. Research in Developmental Disabilities, 14, 253-264.
(14) Vasquez, C. (in press). A multi-task controlled evaluation of facilitated communication. Journal of Autism and Developmental Disorders.
(15) Wheeler, D. L., Jacobson, J. W., Paglieri, R. A., & Schwartz, A. A. (1993). An experimental assessment of facilitated communication. Mental Retardation, 31, 49-60.
]]>I have written a letter to the Obama administration and everyone else I can think of in opposition to this appointment. Please feel free to copy it and/or expound on it and send it to the members of the Senate Health Committee. The letter and committee members are listed below:
]]> I am a Chicago lawyer and a long time supporter of the President. I am writing to express my strong opposition to Dr. Sanjay Gupta as U.S. Surgeon General.
Dr. Gupta has actively promoted facilitated communication (FC) as a valid way to help autistic people communicate. FC has been universally discredited scientifically, a fact Dr. Gupta has chosen to ignore. Consider this small sample of the vast sources rejecting the science of FC:
1. Facilitated Communication the Ultimate Fad treatment; Jacobson, Foxx, Mulick (2005)
2. Prisoners of Science, Frontline 1993
3. American Psychological Association position paper on FC.
4. Facilitated Communication and the Power of Belief: How Time Magazine Got it Wrong
Not only is FC a useless therapy for the autistic it is harmful to the children and families victimized by its use. Instead of being treated with recognized techniques to teach communication, autistic children lose valuable time in their formative years having their hands manipulated like puppets. This has no value for the child, but is financially very rewarding to the people selling FC.
I recently settled a matter with a hospital in Chicago for malpractice solely because FC was used. The responsible hospital paid $1 million to settle before we even filed suit and demanded a confidentiality agreement. The parents of the child in my case were actually convinced by a doctor that their child was a genius trapped in an autistic body. After nine years of FC the family finally realized that they were the victims of the pseudoscientific hoax that is FC.
In his inaugural speech the President said “…we will restore science to its rightful place…” Dr. Gupta is a fine television personality, but no supporter of Facilitated Communication is fit for the country’s top scientific post.
Christopher T. Hurley
Democrats by Rank
Edward Kennedy (MA)
Christopher Dodd (CT)
Tom Harkin (IA)
Barbara A. Mikulski (MD)
Jeff Bingaman (NM)
Patty Murray (WA)
Jack Reed (RI)
Bernard Sanders (I) (VT)
Sherrod Brown (OH)
Robert P. Casey, Jr. (PA)
Kay Hagan (NC)
Jeff Merkley (OR)
Republicans by Rank
Michael B. Enzi (WY)
Judd Gregg (NH)
Lamar Alexander (TN)
Richard Burr (NC)
Johnny Isakson (GA)
John McCain (AZ)
Orrin G. Hatch (UT)
Lisa Murkowski (AK)
Tom Coburn, M.D. (OK)
Pat Roberts (KS)