April 18, 2008
African American Bone Marrow Donors Needed
Wolfrum at Shakespeare's Sister posts a call for more more bone marrow donors, particularly African American donors. He writes,
When I recovered from the shock of learning that my Mom had acute myeloid Leukemia, I set to work on learning more about it, and trying to find what part I could play. It was evident early on that my Mom would need a bone marrow transplant to survive more than one or two years. AML is a vicious disease that can only be repressed by intense chemotherapy. It comes back, and the chemo treatments quickly lose potency. So I saw the part I would play, and knew it would be a lifetime endeavor.
With the help of Pat Conlee of the National Marrow Donor Program, I began to learn about the bone marrow registry. I worked with Conlee, my Father and friends and family to put together a bone marrow drive for my mother in Victorville, Calif. But I knew that was not to be a one-time effort, and that the NMDP needed help from wherever it could find it. As I learned about the NMDP, one fact struck me extremely hard. For Caucasians in need of a bone marrow transplant, 88 percent find a suitable donor. For African-Americans, that number tumbles to 60 percent. . . .
According to the NMDP, there are just 11 million people on the bone marrow donor registry. And that's not in the U.S. That's in the world. In the U.S., there are five million white people on the registry. There are 500,000 blacks. There lies the difference between the 88 percent and 60 percent figures . . . .
To put a face to issue, let me point to my friend Emru Townsend. In December, Townsend - of Montreal - was told that he had AML, as well as a disorder called monosomy 7. He was told he needed a bone marrow transplant to survive. He was also told that due to his African-Caribbean heritage, his chances of finding a donor were much less than if he were white.
But Townsend did not waste his time with self-pity. He immediately began to champion the cause, and his efforts to get more blacks on Canada's bone marrow registry have been covered in newspapers, radio and on television. He is a true inspiration, going so far as spending days working to get his message out while he is receiving chemotherapy. And he is still without a matching donor. His site - HealEmru.com - tells his story and has valuable information on how one can get on the bone marrow registry . . . .
In the U.S., one of the reasons for the lack of donors of all races is likely the cost. It costs $52 to get on the registry, but that amount falls to $25 for African-Americans due to the need. But even if an African-American doesn't have a dime to spare, if they want to get on the registry, they will not be turned away. But this is why donations are always eagerly accepted by the NMDP to help defray the costs of the tissue typing necessary.
The process for donating is simple - all it takes is a few swaps from a person's inner cheek, filling out some paperwork, and it's done. If you are called as a potential match, you will be given a battery of tests (free of charge) that will see if you are in good health and able to donate. The donating process consists of taking some marrow from your spine (under local anesthesia) and does not entail an overnight stay in a hospital. Generally, some minor discomfort for a day or two is the full price that has to be paid for saving a life. . . . .
Wolfrum's piece provides a list of helpful weblinks as well.
Wyden's Health Care Plan Video
Ezra Klein points out the surprisingly good health care video produced in support of Senator Ron Wyden's health care plan, known as the Wyden Bennett plan or Healthy Americans Act. The Act proposes to de-link health insurance from employment. The video is rather bittersweet (it is sad what people do for health insurance). It is also rather funny - I am sure that all of us have worked at jobs where we would rather not be and have considered engaging in some slightly unprofessional behavior at times . . . . ok, perhaps it is just me.
Here is some background on the Wyden Bennett Act/Healthy Americans Act:
The Healthy Americans Act would guarantee every American universal, affordable, comprehensive, portable, high-quality, private health coverage that is as good or better than Members of Congress have today. The Act includes tough cost containment measures - and would save Americans $1.45 trillion over the next decade. All 46 million uninsured Americans would be covered, for the same funds currently spent by Americans on health care. And every American will feel secure, knowing that your health care won't ever go away.
There are, of course, many details. Here's a few of the highlights.
The Healthy Americans Act:
- guarantees you private health care coverage that doesn't go away, even if you change jobs, lose your job, retire, go to school, or become too sick to work.
- provides a generous benefit equal to those of Members of Congress
- ensures that everyone has affordable health care coverage, including meaningful assistance to low-income Americans.
- puts you in charge of your health care choices, not your employer
- makes sure that everyone has the same affordable coverage options, no matter your age, gender, genetic information, or pre-existing health conditions
- saves $1.48 trillion over 10 years through tough cost containment
- provides incentives for individuals and insurers to focus on prevention, wellness and disease management
- creates meaningful and easy-to-understand wellness statistics so that Americans can compare health care plans
- is fully paid for by spending the $2.2 trillion currently spent on health care in America.
More information about the Act is available at Senator Wyden's website.
April 17, 2008
Vioxx Deaths, Merck's Data and Ghostwriters
Guardian reports on the bad data provided by Merck and the New York Times follows up with a review of yesterday's Journal of the American Medical Association piece discussing ghostwriters for medical articles on Merck data and analysis. Sarah Boseley for the Guardian writes,
A multinational drug company that made a painkiller that had to be withdrawn from sale because it was found to cause heart attacks may have hidden the death rate from the authorities for several years, it was claimed yesterday. Internal company documents released during litigation in the US suggest that Merck, makers of Vioxx, gave the US Food and Drug Administration only selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug. . . . .
Bruce Psaty and Richard Kronmal, from the University of Washington in Seattle, say that internal company records from 2001 give 34 deaths among the 1,069 Vioxx patients from two of the Alzheimer's trials and 12 among the 1,078 on placebo - a threefold increase among those on the drug. But the published data of the first study in 2004 stated there were 11 deaths which were "non drug-related" among 346 Vioxx patients, and two among those on placebo. In the second study published in 2005 there were said to be 24 deaths among 725 Vioxx patients and 15 among the 732 on placebo, with 17 and two more respectively within 14 days of the last dose. But, say the researchers, neither study analysed the mortality data.
In July 2001, Merck had reported mortality data to the FDA. Psaty and Kronmal wrote that "deaths that had occurred more than 14 days after discontinuation of the trial drug apparently were not included". When the FDA questioned the figures, in December 2001, it emerged that there was no independent data. The second journal paper reveals that manuscripts for scientific journals were written by Merck employees. Doctors attached to leading universities would then be invited to take authorship. Some, but not all, declared financial support from industry.
The New York Times provides more details on the ghostwriters for Merck and suggested reforms for medical publishers by the Journal of the American Medical Association,
The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal. The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals. The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as “External author?” . . . .
The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” said Dr. Ross, whose article, written with colleagues, was published Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal’s Web site.
Merck acknowledged on Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis. The final work is the product of the doctor and “accurately reflects his or her opinion,” said a Merck lawyer, James C. Fitzpatrick.
And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published journal articles. In an editorial, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx. “It is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors,” the editorial said.
The editorial called upon medical journal editors to require each author to report his or her specific contributions to articles. “Journal editors also bear some of the responsibility for enabling companies to manipulate publications,” the editorial said. JAMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article. . . . .
Although the role of pharmaceutical companies in influencing medical journal articles has been questioned before, the Merck documents provided the most comprehensive look at the practice yet, according to one of the study’s four authors, Dr. David S. Egilman, a clinical associate medical professor at Brown University. . . .
One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression. The draft of the paper, dated August 2003, identified the lead writer as “External author?” But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon J. Thal, a well-known Alzheimer’s researcher at the University of California, San Diego. Dr. Thal was killed in an airplane crash last year. The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Dr. Ferris, the New York University professor. Dr. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft. “It’s simply false that we didn’t contribute to the final publication,” Dr. Ferris said.
A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document. “The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,” Dr. Kirby’s e-mail message said.
The current editor of the journal Neuropsychopharmacology, Dr. James H. Meador-Woodruff, the chairman of psychiatry at the University of Alabama, Birmingham, said he was not the editor in 2005 but planned to investigate the accusations. “Currently, we have in place prohibitions against this,” Dr. Meador-Woodruff said.
Plastic Baby Bottles, BPA and the FDA
Reuters reports on the National Toxicology Program's findings of the potential danger posed to young children from the chemical bisphensol A, a chemical used in such items as baby bottles and also recently approved by the FDA as safe in products used by infants and children. Will Dunham writes,
Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children. The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.The National Toxicology Program went further than previous U.S. government statements on possible health risks from BPA.
It said: "There is some concern for neural and behavioral effects in fetuses, infants and children at current human exposures." The findings expressed concern about exposure in these populations, "based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females." . . . .
The National Toxicology Program said laboratory rodents exposed to BPA levels similar to human exposures developed precancerous lesions in the prostate and mammary glands, among other things. "The possibility that bisphenol A may impact human development cannot be dismissed. More research is needed," the agency said. Bisphenol A is used in the production of polycarbonate plastics and epoxy resins and can be found in food and drink packaging as well as compact discs and some medical devices. Some dental sealants or composites contain it as well.
The National Toxicology Program expressed "negligible concern" that exposure of pregnant women to BPA causes fetal or neonatal death, birth defects or reduced birth weight and growth in babies. It also had "negligible concern" that exposure causes reproductive problems in adults. . . .
In Canada, the Globe and Mail newspaper said the Canadian health ministry was ready to declare BPA a dangerous substance, making it the first regulatory body in the world to reach such a determination. The newspaper said the ministry could announce the decision as soon as Wednesday. . . .
This follows yesterday's news from the New York Times that Senators from both parties believe the FDA is underfunded.
The Food and Drug Administration needs far more money than the White House has proposed for next year, senators of both parties said Tuesday. “To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the agency’s spending. The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely. . . .
The Senate passed a budget resolution last month that would make the F.D.A.’s allocated budget — that part of its spending that comes from taxpayer revenue, as opposed to user fees paid by drug and medical device manufacturers — $375 million greater in 2009 than this year. That would be a 20 percent increase, and Dr. von Eschenbach said he did not believe that the agency could absorb so large an addition in one year.
A report last year by a panel of outside advisers to the agency said American lives were in danger because the F.D.A. did not have the money, the staff or the scientific expertise to protect them. And in a speech last month, Dr. von Eschenbach acknowledged that the F.D.A. “may fail in its mission to protect and promote the health of every American” and that “peril exists.” But he was far less pessimistic in his testimony on Tuesday. “I believe we have been eminently successful up to this period of time,” Dr. von Eschenbach said. “We are the world’s gold standard. “But if we want to continue that level of excellence,” he added, “we must change.”
The Bush administration has proposed increasing the agency’s allocated budget next year by 3 percent, to some $1.8 billion, not enough to pay even for increased costs. Dr. von Eschenbach spoke Tuesday about plans to hire up to 700 new employees for the F.D.A. staff, but he acknowledged that the agency would not have the money to do any hiring next year if the president’s budget was adopted without changes by Congress. . . .
Perhaps the FDA's problems go deeper than lack of funding . . .
April 16, 2008
Antioxidant Supplements May Be Harmful to Health
The Guardian (UK) reports today on a review by the Cochrane Collaboration which demonstrates that in many cases taking vitamin supplements, specifically antioxidants, in the hopes of extending life is not only a waste of money but can actually be detrimental to your health. James Randerson for the Guardian writes,
Vitamin supplements taken by millions of people do not increase life expectancy and may raise the risk of a premature death, according to a review of 67 studies with more than 230,000 subjects.
The review, by the Cochrane Collaboration which regularly pools data from trials to evaluate drugs and treatments, found supplements vitamin A, vitamin E and beta-carotene are detrimental to health. In 47 trials with 180,938 people and a low risk of bias, the "antioxidant supplements significantly increased mortality", the authors wrote. When the antioxidants were assessed separately and low risk of bias trials were included and selenium excluded, vitamin A was linked to a 16% increased risk of dying, beta-carotene to a 7% increased risk and vitamin E to a 4% increased risk. Evidence for vitamin C and selenium was more equivocal, suggesting there was no benefit to taking these pills compared with a placebo.
"The bottom line is current evidence does not support the use of antioxidant supplements in the general healthy population or in patients with certain diseases," said Goran Bjelakovic, who performed the review at Copenhagen Universityhospital in Denmark. "There was no indication that vitamin C and selenium may have positive or negative effects. So regarding these we need more data from randomised trials." . . . .
Bjelakovic's team evaluated 67 randomised clinical trials with 232,550 subjects; 21 of the trials were on healthy subjects, while the rest tested patients with a range of diseases. The evidence suggests it would be safer to obtain the chemicals not as supplements but by eating plenty of fruit and vegetables.
Banning the Internet From Law School Classrooms
The National Law Journal online reports on the recent decision by the University of Chicago Law School Dean to block classroom access to the internet. Lynne Marek states,
Saul Levmore, who is dean of the school, said he had been trying to simply persuade students not to distract themselves with the Internet during class, but turned to simply shutting off access when he found that the school's building had the capability to block wired and wireless access. "It got a lot easier when I found I had technology on my side," he said in an interview. Keeping students from surfing the Internet during class is similar to keeping them from picking up calls on their cell phones, he said. Levmore has received inquiries from about 10 other law schools interested in possibly following suit on the move, he said.
I know that some of my students surf the internet during my classes but sometimes it can be beneficial. For instance, a student might be interested enough by a case that she looks to see what happened after the court's decision, or a student might remember an interesting case similar to that discussed in class and with google can quickly call up that case. I do recognize, however, the downsides and I am aware that some students are searching sports scores or sending e-mails. As for the ban, I am not sure that it will accomplish the objective of having students more focused on their classwork. Before the internet was available in classrooms, I had students playing solitaire and other games (I swear I am not super boring) so I am not sure that blocking access to the internet will correct a lack of focus on the part of some students.
April 15, 2008
Calling Health Law Scholars
Now that classes are soon to be over, time to consider scholarship - St. Louis University School of Law Center for Health Law Studies announces is call for papers for its 2008 Health Law Scholars Workshop.
Call for Papers
May 2 - Submission of Abstracts for Consideration
May 23 - Notification of Selection of Workshop Scholars
Sept. 1 - Works-in-Progress Due
Oct. 17 to 19 - Scholars Weekend
The Center for Health Law Studies at Saint Louis University and the American Society of Law, Medicine & Ethics are pleased to announce the 2008 Health Law Scholars Workshop. The Health Law Scholars Workshop is a collegial forum in which faculty new to health law and bioethics scholarship present works-in-progress and receive in-depth advice from experienced scholars and teachers in the field of health law and bioethics. The Workshop encourages health and bioethics scholarship, fosters the professional development of emerging scholars and furthers the sense of community among health law academics. Past Scholars have placed their papers for publication in pre-eminent health law, policy and bioethics journals.
Scholars workshop their work-in-progress before a group of experienced peer reviewers and commentators. Each author's work-in-progress accepted for the Health Law Scholars Workshop will be read in advance by three or four faculty members in relevant fields. During the Workshop weekend, each author presents his or her paper to the full group. After extensive oral feedback from the readers, the floor is opened for a sustained exchange between the presenter and full group.
The Workshop draws health law and bioethics scholars from across the country, inviting senior faculty from a variety of law schools and disciplines to review the works-in-progress and participate in the weekend. The Workshop also draws on the expertise of Saint Louis University faculty from the Center for Health Law Studies, the University's Medical School, School of Public Health, Nursing School and Center for Health Care Ethics.
Each spring there is a call for submission of abstracts for consideration, and each fall the annual Health Law Scholars Workshop is held at Saint Louis University.
A nominating committee selects the papers to be presented at the Workshop. The committee looks for papers that have an original thesis and will contribute to the scholarly literature. The Workshop is intended primarily to provide feedback on articles intended for spring submission to law review journals, although works intended for other types of publications are welcome. The Workshop is not designed to review published work or papers already accepted for publication.
Those interested in presenting a health law or bioethics work in-progress at the Health Law Scholars Workshop should submit a one-page abstract of the proposed paper together with a resume to Mary Ann Jauer at Saint Louis University School of Law by May 2, 2008. Because a blind selection process is used, please do not include the author's name or institutional affiliation on the abstract. Submissions may be made by mail, fax or e-mail to:
Mary Ann Jauer, Program Coordinator
Center for Health Law Studies
Saint Louis University School of Law
3700 Lindell Boulevard
St. Louis, MO 63108
Global Medical Tourism
Yesterday's NPR program Day-to-Day had an interesting program concerning global medical tourism and how many Americans were going overseas, the program focuses on Israel, to gain access to medical care at a much lesser cost. Here is link to the program's audio. Below is a brief overview of the program's contents.
Thousands of "medical tourists" travel to Israel every year to take advantage of its state-of-the-art medical system. Even with the cost of flights and hotel, in vitro fertilization and cancer care in Israel costs far less than in the U.S. or Europe.
Human Research - The Importance of Consent
The Boston Globe reports on a recent (and rather shocking) incident in low-income, minority neighborhoods in Baltimore concerning the use of human and industrial waste on yards to reduce potential lead poisoning without knowlege of the participants. Globe reporter John Heilprin writes,
Scientists using federal grants spread fertilizer made from human and industrial wastes on yards in poor, black neighborhoods to test whether it might protect children from lead poisoning in the soil. Families were assured the sludge was safe and were never told about any potential risks.
Nine low-income families in Baltimore row houses agreed to let researchers till the sewage sludge into their yards and plant new grass. In exchange, they were given food coupons as well as the free lawns as part of a study published in 2005 and funded by the Department of Housing and Urban Development.
The Associated Press reviewed grant documents obtained under the Freedom of Information Act and interviewed researchers. No one involved with the $446,231 grant for the two-year study would identify the participants, citing privacy concerns. There is no evidence there was any medical follow-up. Comparable research was conducted by the Agriculture Department and Environmental Protection Agency in a similarly poor, black neighborhood in East St. Louis, Ill. Residents there also were not told of the potential risks.
The researchers said the sludge could help protect the children from brain or nerve damage from lead, a highly toxic element once widely used in gasoline and paint. Other studies have shown brain damage among children, often in poor neighborhoods, who ate lead-based paint that had flaked off their homes. . . .
The Baltimore study concluded that phosphate and iron in sludge can increase the ability of soil to trap more harmful metals including lead, cadmium, and zinc, causing the combination to pass safely through a child's body if eaten. The results were published in Science of the Total Environment, a research journal, in 2005. However, there has been a paucity of research into the possible harmful effects of heavy metals, pharmaceuticals, other chemicals, and disease-causing microorganisms often found in sludge. A series of reports by the EPA's inspector general and the National Academy of Sciences between 1996 and 2002 faulted the adequacy of the science behind the EPA's 1993 regulations on sludge.
The chairman of the 2002 academy panel, Thomas Burke, a professor at the Johns Hopkins Bloomberg School of Public Health, said epidemiological studies have never been done to show whether spreading sludge on land is safe. "There are potential pathogens and chemicals that are not in the realm of safe," Burke said. "What's needed are more studies on what's going on with the pathogens in sludge - are we actually removing them? The commitment to connecting the dots hasn't been there."
Rufus Chaney, an Agriculture Department research agronomist who co-wrote the Baltimore study, said the researchers gave the Baltimore and East St. Louis families assurances that the Orgro fertilizer was store-bought and safe. "They were told that their lawn, as it stood, before it was treated, was a lead danger to their children," Chaney said. "So that even if they ate some of the soil, there would not be as much of a risk as there was before. And that's what the science shows."
April 14, 2008
The journal Nature Neuroscience latest edition focuses on the Nature of Decision-Making. The studies are quite interesting and do raise many questions about how our brain works. Here is the brief overview of the journal's articles,
The ability to make appropriate choices is critical for survival. Successful decision making requires the integration of sensory information, motivational states and potential outcomes to select the best action. Recently, there has been great progress in our understanding of the neural mechanisms supporting decision making in a wide range of contexts, including risky choices and social interactions. This special focus on decision making contains four reviews that highlight recent achievements in this important field.
Using sophisticated brain imaging techniques, the researchers found that they can predict people's simple decisions up to 10 seconds before they're conscious of making such a choice. "It seems that your brain starts to trigger your decision before you make up your mind," said the study's lead author, John-Dylan Haynes of the Max Planck Institute for Human Cognitive and Brain Sciences in Germany. "We can't rule out free will, but I think it's very implausible. The question is, can we still decide against the decision our brain has made?" The study is the latest salvo in a longstanding scientific and philosophical debate over whether what we perceive as "free will" decisions are actually made before we're aware that we're making them. . . .
In this experiment, however, Haynes and his colleagues found that two regions of the brain responsible for even higher-order decision-making - the frontopolar cortex and the parietal cortex - were activated even earlier when people were asked to press a button with either their right or left hands. Employing both functional magnetic resonance imaging and pattern recognition statistical techniques, the researchers were able to predict which button people would choose before they made their conscious decisions - as much as 10 seconds early, "an eternity," Haynes said. Haynes believes that delay suggests the absence of free will as most people define it. . . .
Tufts University philosopher Daniel Dennett, on the other hand, offers a different way of thinking about the results of Haynes's experiment: "If you take a deep breath and think about it more, the making of the decisions themselves takes time. The noticing of the decision takes time," Dennett said. "That doesn't mean that we don't have free will."
Decision neuroscience, as this field of study is called, has potential applications in medicine, economics, marketing, consumer behavior, even criminal justice. In the future, research in the field could help people with neurological motor disorders such as Parkinson's disease. It also could identify people whose decision-making abilities are impaired through injury or from birth, leading to poor judgment or even criminal behavior. "We're getting closer and closer to understanding how the brain works and how the mind works," Dennett said. "We obviously can't help these conditions until we do."
Abortion Records in Kansas
Phil Kline, the Johnson County District Attorney, who has been filing criminal cases against Planned Parenthood, has requested and thus far been denied medical records from the various clinics. The Kansas City Star reports here and here on how his case is proceeding. Mr. Kline had subpoenaed the medical records but the Health and Environment Department has refused to turn them over to him. According to the Kansas City Star,
A Kansas agency has refused to turn over abortion records subpoenaed by Johnson County District Attorney Phill Kline. And if Kline doesn’t get them, Planned Parenthood attorneys said Monday, Kline’s criminal case against Planned Parenthood could crumble. “If he (Kline) doesn’t have the evidence, how can he prosecute?” asked Planned Parenthood attorney Pedro Irigonegaray. “… Without records, that is an impossible task.” District Court Judge Stephen Tatum has scheduled a hearing for Wednesday on a motion to quash the subpoena filed Friday by the Kansas Department of Health and Environment.
Kline wants the agency to produce the records and provide testimony authenticating them at a two-day preliminary hearing scheduled for Monday and Tuesday. Health and Environment Department spokesman Joe Blubaugh said his agency’s attorneys say the law prohibits them from turning over the records. However, Blubaugh said, “we’ll comply with whatever the court rules on it.”
Kline in October filed a 107-count criminal complaint against Planned Parenthood of Kansas and Mid-Missouri and Comprehensive Health, its Overland Park clinic. Twenty-three of the counts, which are felonies, accuse the clinic of “making a false information.” Specifically, those counts accuse the clinic of manufacturing or forging documents in August 2006 regarding 23 late-term abortions. Kline is seeking the state agency’s records regarding those abortions. The remaining counts are misdemeanors. They accuse the clinic of 26 counts of failing to maintain records sometime between 2003 and 2006; of 30 counts of failing to determine the viability of a fetus before late-term abortions performed on various dates in 2003; and of 28 counts of performing illegal late-term abortions on various dates in 2003. Irigonegaray contends all the misdemeanor charges are based upon information contained in the 23 records that Kline has subpoenaed.
In the Health and Environment Department’s motion to quash, chief legal counsel Yvonne Anderson writes that state law allows identifying information on abortion patients to be released only to the state attorney general and the state Board of Healing Arts — and then only for use in a criminal or disciplinary proceeding. Anderson pointed out that legislation is pending to change those rules; state Rep. Lance Kinzer, a Republican from Olathe, has introduced a bill that would allow district attorneys to access the records.
Irigonegaray said the records Kline is seeking already have been reviewed by former Kansas Attorney General Paul Morrison. Morrison’s investigation of Planned Parenthood found no evidence of criminal wrongdoing. However, during a January court hearing on Kline’s criminal complaint, Shawnee County District Judge Richard Anderson raised questions about whether Morrison should have cleared the clinic. Anderson testified that his review of the abortion records showed that information provided by Planned Parenthood did not “match up” with records from the state agency. . . .
April 13, 2008
Drug Companies and their New Disclosures
The Associated Press reports on some new disclosures by pharmaceutical companies concerning gifts and payments made to physicians. Kevin Freking writes,
For years, the nation's largest drug and medical device manufacturers have courted doctors with consulting fees, free trips to exotic locales and by sponsoring the educational conferences that physicians attend. Those financial ties don't have to be disclosed in most cases and can lead to arrangements that some say improperly influence medical care.
Now, under the threat of regulation from Congress, the two industries promise to be more forthcoming about their spending. A dozen of the nation's leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company's Web sites. Watchdog groups say the companies are trying to head off legislation that would require public disclosure of their giving. "If they were doing this out of the goodness of their heart, they would have done so decades ago," said Dr. Peter Lurie of the consumer group Public Citizen.
Of particular interest to Grassley is the money that companies spend on continuing medical education. Physicians go to such conferences to fulfill their license requirements and to keep up to date with the latest treatment trends. Professional associations and companies frequently ask drug and device makers to help pay for the conferences. Recently, Grassley asked 15 companies whether they planned to follow the lead of Eli Lilly & Co., which now discloses its grants to such programs. . . .
The responses are in. They are wide-ranging, but mostly what the senator wanted to hear. Indeed, many of the companies said they would go beyond disclosing grants for medical education. Some companies said they would also disclose payments to patient advocacy groups such as the American Heart Association or the American Diabetes Association. Boston Scientific said it was developing a system that even discloses certain payments to physicians. . . .
If all of the companies follow through with their commitments to Grassley, there also would be widespread disclosure of how much money they give patient advocacy groups. The groups rely on industry for much of their financing. For example, the American Heart Association said donations from the pharmaceutical and device industry make up about 6 percent of its annual income, and totaled $48.3 million in the organization's latest fiscal year. . . .
"Donations from corporations, including the pharmaceutical and device industry, allow us to further enhance our programs and outreach, and to bring objective science and the highest quality of public education and information to more people," said Maggie Francis, the association's communications manager.
Grassley and Sen. Herb Kohl, D-Wis., have introduced legislation that would require drug and device makers to disclose anything of value given to physicians, such as payments, gifts or travel. The disclosure of medical education grants is an extension of that concept. Last year, the staff for the Senate Finance Committee issued a report that said the drug industry may be using the "medical education industry to deliver favorable messages about off-label uses that the drug companies cannot legally deliver on their own."
The committee report noted that Warner-Lambert, now owned by Pfizer Inc. (PFE), paid $430 million to settle claims that medical conferences it sponsored were used to illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704 million to settle a similar claim concerning the AIDS drug Serostim.