Posts Tagged ‘conflicts of interest’
Monday, August 30th, 2010
by Jim Edwards
BNET August 30, 2010
The NYT Sunday magazine crowned Dr. Joan Luby as the queen of preschool depression this weekend, but failed to mention that Luby has taken cash from Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN) to study using atypical antipsychotics in young children. The article is significant because of the outsize role that the Times magazine plays in creating and naming new social trends. (Remember when you suddenly figured out that carbs make you fat but fatty meat doesn’t? That was the NYT mag.)
In this case, the phenomenon is depression in children as young as three years old, and the trend is to treat it with drugs such as Risperdal, Zyprexa, Adderall and Seroquel. The article, by Pamela Paul, provides a useful roadmap into how parenting will be medicalized by Big Pharma:
“The idea is very threatening,” says Joan Luby, a professor of child psychiatry at Washington University School of Medicine, … “In my 20 years of research, it’s been slowly eroding,” Luby says of that resistance. “But some hard-core scientists still brush the idea off as mushy or psychobabble, and laypeople think the idea is ridiculous.”
The “ridiculous” layperson who first pointed out that Luby had written medical journal articles urging the use of antipsychotics on preschool children without declaring her drug company payments was me. Luby was a paid speaker for AstraZeneca in 2003-2004 (AZ makes Seroquel); she received $2019 in a for a consultancy from Shire in 2004 (Shire makes Adderall and Vyvanse); and prior to 2006 she received grant/research support from Janssen, the unit of J&J that markets Risperdal. Luby is also a member of a group of scientists who want greater study of potential new uses for psychiatric drugs in young children. That group has ties to 16 different drug companies. Some of these drugs have dangerous side effects.
The Archives of General Psychiatry (published by the American Medical Association) said it would investigate how Luby failed to disclose her past ties when it published “Preschool Depression,” a study she did on 3- to 6-year-olds. Joseph Coyle, the editor of the AGP, did not immediately respond to an email requesting an update on its Luby probe. (The American Psychiatric Association, which publishes the American Journal of Psychiatry, has chosen to ignore the issue.)
Read the rest of this article here: http://www.bnet.com/blog/drug-business/meet-the-queen-of-8220preschool-depression-8221-8212-and-her-drug-company-backers/5595
To read about other pharma funded psychiatrists promoting a psycho/pharma agenda read Shrinks For Sale – The Corrupt Alliance of the Psychiatric-Pharmaceutical Industry by CCHR http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/
Also read DSM Panel Members Still Getting Pharma Funds by CCHR http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/
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Tags: Adderall, American Psychiatric Association, antipsychotics, Astra Zeneca, conflicts of interest, Consultant, drug company backers, drug company payments, Janssen, Joan Luby, pharma-funded, preschool depression, preschoolers, queen of preschool depression, Risperdal, Seroquel, Shire, side effects, Zyprexa
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Friday, August 20th, 2010
MinnPost.com
By Susan Perry |
In the September issue of Mother Jones magazine, Dr. Carl Elliott, a professor of bioethics at the University of Minnesota, writes about the suicide in 2004 of 26-year-old Dan Markingson, who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine).
It’s a disturbing tale (the unsuccessful efforts of Markingson’s mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.
But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson’s story. “[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”
Those hazards include questionable informed consent (is a young man who’s experiencing psychotic episodes competent to give his consent?) and financial conflicts of interest. According to Elliott, the U of M psychiatry department earned $15,648 for each person it enrolled in the Seroquel study. In addition, the study’s two U of M investigators, Drs. Charles S. Schulz and Stephen C. Olson, personally earned a combined $811,045 between 2002 and 2008 from Big Pharma, including $261,364 from AstraZeneca, the maker of Seroquel.
At the time Markingson entered the Seroquel study, reports Elliott, the investigators were having serious problems recruiting subjects. Did that factor lead them to enroll someone into the study who shouldn’t have been?
“Even by the standards of a fairly ugly history [of clinical drug trials with ethical breaches] in medical history — even by those standards, this [case] jumps up,” Elliott told me in an interview last week. “There were so many things that went wrong — the consent process, the commitment order under which [Markingson] was recruited into the trial, the financial incentives of the university, the financial incentives of the investigators, and the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible.”
Elliott sees the trial’s worthlessness as a particularly abhorrent part of the story. The Seroquel study was designed as a marketing tool, he suggests, not as a true scientific inquiry. Such studies, he writes, present a huge ethical problem that isn’t being properly addressed by the oversight systems currently in place:
What is simply assumed [when bioethicists and regulators debate the risks of a clinical trial], without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. … But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation [involving various prescription drugs] suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generative commercially attractive messages”?
Or, as Elliott told me: “I don’t think anybody who enrolls in a clinical trial thinks, “I know this study is risky, but I think it’s worth it to help Pfizer or AstraZeneca market their drug.”
Read the rest of this article here: http://www.minnpost.com/healthblog/2010/08/20/20742/disturbing_suicide_tale_u_of_m_professor_reexamines_ethics_questions_of_drug_trial
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Tags: antipsychotic, AstraZeneca, big pharma, Carl Elliot, Charles S Schultz, clinical drug trials, conflicts of interest, drug trials, drugs, human subjects, market, Mother Jones, Naxi experiments, Nuremburg Code, Pfizer, Seroquel, Stephan C Olsen, U of M, University of Minnesota
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Tuesday, August 17th, 2010
The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010
At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.
In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.
But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.
Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.
More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.
Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.
Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.
“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.
Read entire article here: http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp
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Tags: anti-bribery laws, bribery, clinical trials, conflicts of interest, consulting, corruption probe, Daniel R. Levinson, Department of Health and Human Services, Drug companies, Foreign Corrupt Practices Act, GlaxoSmithKline, pharmaceutical companies, pharmaceutical industry, psychiatric drugs, psychiatry
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Friday, July 30th, 2010
OpEdNews
By K. L. Carlson
July 30, 2010
“Unlimited spending! Schedule all the programs you can.” That was the management directive announced at the regional business meeting I attended when I first became a pharmaceutical rep. When I heard the announcement I felt like I was on an Enron train that was roaring down the tracks, and the company expected everyone to be on board. The company was giving its sales force unlimited funds to hire physicians as paid speakers, sometimes to influence other physicians to prescribe the company’s drugs, at other times to simply financially reward physicians who wrote high volumes of prescriptions every month for the company’s drugs.
Former Merck regional sales manager, Gene Carbona, told the New York Times that the only thing the company considered when selecting physicians to provide presentations was “the volume or potential volume of prescribing that the doctor could do.” This is true of all pharmaceutical companies. According to The Wall Street Journal (August 31, 2009), Eli Lilly alone paid physicians $22 million dollars in just the first quarter of 2009.
The higher a physician is on the influential ladder, the greater the financial rewards to be reaped. Pharmaceutical companies pay influential leaders who can sway public opinion and influence research. And the area of medicine receiving the greatest amount of pharmaceutical money is psychiatry. The American Psychiatric Association (APA) is the most drug industry financially supported medical association. In July 2008, Senator Charles Grassley’s demands that the APA provide an accounting of its finances revealed that in 2006 the pharmaceutical industry accounted for about 30 percent of the APA’s financing; more than $20 million dollars.
Read entire article here: http://www.opednews.com/articles/Pharmaceutical-Industry-an-by-K-L-Carlson-100727-454.html
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Tags: conflicts of interest, Conjoined Twins, drug company, drugs, Eli Lilly, Kay L. Carlson, Merck, paid speakers, pharmaceutical companies, pharmaceutical industry, pharmaceutical rep, prescriptions, psychiatry, Wallet, whistleblower
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Friday, May 21st, 2010
Also see: DSM Panel Members Still Getting Pharma Funds
By CCHR International
May 21, 2010
NEW ORLEANS – As psychiatrists from around the world flood the area this weekend to take part in the Annual Meeting of the American Psychiatric Association (APA), psychiatric watchdog Citizens Commission on Human Rights (CCHR) is demanding that the APA sever all ties to pharmaceutical company interests and that psychiatrists stop killing children with harmful drugs.
The APA is expected to release its guidelines to reduce pharmaceutical industry ties at its convention, but it is likely to be self-serving and occurred only after public and legislative pressure forced the issue.
The US Senate Finance Committee has investigated at least 16 APA psychiatrists over their undisclosed financial ties to drug companies, including the APA’s own President, Alan Schatzberg who has stepped down as principal investigator of a National Institute of Health (NIH) funded study after months of Congressional scrutiny into his ties to the drug he was studying. He was found to have actually initiated the patent application of the drug he was studying to “treat psychotic depression.”
Other notable APA members under scrutiny by the Senate Finance Committee and scheduled to present in New Orleans are Thomas Spencer, Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Dr. Joseph Biederman, Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital.
Dr. Spencer reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007. Dr. Biederman earned $1.6 million in consulting fees from drug makers during the same period, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic risperidone (Risperdal) would prove effective when used on preschool age children. Risperdal has been linked to potentially life-threatening diabetes and Neuroleptic Malignant Syndrome. The FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with newer antipsychotics and 1,328 reports of other serious side effects, some life-threatening.
Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added]. Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry. Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.
While APA leaders and members profit from their industry connections to the drugs they are promoting; children are being killed by these same drugs.
Also see: Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry
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Tags: Alan Schatzberg, American Psychiatric Association, APA, CCHR, child drugging, Citizens Commission on human rights, conflicts of interest, Drug companies, drug company ties, dsm, DSM-5, financial ties, Johnson & Johnson, joseph biederman, Nada Stotland, New Orleans, Patrick McGorry, pharma, psychiatric drugs, psychiatrists, psychotropic drugs, Risperdal, risperdone, Thomas Spencer, US Senate Finance Committee
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Tuesday, March 30th, 2010
The Faster Times
By Alison Bass
March 30, 2010
First the good news: The Physician Payment Sunshine Act is now law, signed by President Obama as part of the health care bill overhaul. Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website. This is an important first step toward making transparent the pervasive financial ties between doctors who are studying or promoting specific drugs and medical devices and the companies that manufacture these products.
There is one significant loophole in the law: according to thefinal provisions, payments related to clinical trials or product development agreements for new products are allowed a publication delay of four years or until product approval, whichever comes first. So if a particular doctor is researching a drug that has not yet been approved for a specific condition, we will have to wait four years to find out whether he or she is on the drug company’s payroll. But at least the disclosure will eventually see the light of day, and patients who are prescribed the drug in question can seek a second opinion from a doctor who is not on the drug firm’s payroll and whose medical judgment can be trusted.
The Physician Payment Sunshine Act, however, only goes so far. While it covers doctors and teaching hospitals, it does not extend to all the advocacy groups and professional organizations that have substantial influence on over how particular illnesses are treated. For example, as I reported, the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness, received millions of dollars in funding from drug companies for years — a payola that no doubt spurred this group’s embrace of potent psychoactive drugs over alternative methods of treating mental illness.
And now, in the current Psychiatric Times, two Massachusetts researchers tear the veil off efforts by the American Psychiatric Association (APA) to hide industry funding of its two philanthropic arms — the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE). As Lisa Cosgrove and Harold Burszstajn report: “While the APA recently announced it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding” of APF and APIRE.
Read entire article: http://thefastertimes.com/healthinvestigations/2010/03/30/the-troubling-link-between-big-pharma-and-the-american-psychiatric-association/
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Tags: American Psychiatric Association, American Psychiatric Foundation, American Psychiatric Institute for Research and Education, APA, APF, APIRE, conflicts of interest, disclosures, Drug companies, health care bill, Lisa Cosgrove, NAMI, National Alliance for the Mentally Ill, Physician Payment Sunshine Act, psychoactive drugs, Senator Charles Grassley, transparency
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Friday, March 26th, 2010
Pharmalot
By Ed Silverman
March 25, 2010
Two essays published in separate periodicals this week raise troubling questions about the extent to which psychiatrists may be unduly influenced by the pharmaceutical industry, and how this relationship may effect public trust in psychiatry. The upshot? The concern about corruption, or at least the appearance of corruption is palpable. Sigmund Freud would not be pleased. Interestingly, one of the authors is Tom Insel, the director of the National Institute of Mental Health.
For instance, Lisa Cosgrove and Harold Bursztajn write in Psychiatric Times that they looked at the two philanthropic arms of the American Psychiatric Association – the American Psychiatric Foundation and the American Psychiatric Institute for Research and Education – and found that APF’s 15-member board includes four high-level pharma execs that either make meds recommended by APA or are developing products targeted to treat mental disorders. Other board members include two more with industry ties and a senior vp at Fleishman Hillard, the public relations firm whose clients include six drugmakers.
APF’s corporate advisory council lists drugmakers, they continue, that contribute “significant funding” to APF and that make meds recommended in the APA’s clinical practice guidelines. Although it was not possible to discern the total amount of industry funding given to APF, in fiscal year 2008 APF lists 11 pharmaceutical companies and 1 medical device manufacturer that contributed monies; 6 of the companies are listed as giving $40,000 “and above” per year.
They go on to write that APIRE, like APF, doesn’t require disclosure of financial conflicts of interests, and that nine of 16 APIRE board members have ties to drugmakers. They also note current disclosure policies don’t require reporting of pooled industry money to academic departments, units, hospitals, and med schools. And because there is no independent monitoring of industry ties, they maintain “underreporting is very likely a problem. For example, one board member who reported ‘no disclosure’ in an APA publication was found to be on the speakers’ bureau of multiple pharmaceutical companies.”
Read entire article: http://www.pharmalot.com/2010/03/psychiatrists-and-pharma-undue-influence/
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Tags: American Psychiatric Association, American Psychiatric Foundation, American Psychiatric Institute for Research and Education, APA, APF, APIRE, conflicts of interest, disclosures, Drug companies, dsm, ethics cleanup, JAMA, Lisa Cosgrove, National Institute of Mental Health, NIMH, pharmaceutical funding, pharmaceutical industry, Physician Payments Sunshine Act, psychiatrists, psychiatry, Senator Charles Grassley, Thomas Insel, top psychiatrist
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Wednesday, March 24th, 2010
FiercePharma
By Tracy Staton
March 24, 2010
Is the new Journal of the American Medical Association a special issue on reform? It doesn’t stop with its demands for new publication standards. It’s also showcasing a rallying cry from National Institute of Mental Health Director Dr. Thomas Insel, who calls on his fellow psychiatrists to “clean up our act.”
In Insel’s estimation, psychiatry has grown too close to drugmakers. All the money flowing from pharma to psychiatrists and psychiatric researchers has created a “culture of influence,” he says, and psychiatrists need to rise above all that. He wants all financial ties between drugmakers and psychiatry to be disclosed, and for psychiatrists to take a step back from branded meds in favor of generic drugs and non-drug treatments such as talk therapy.
This is far from the first call for change in psychiatry. Over the past three years, congressional probes have repeatedly highlighted influential psychiatrists’ financial relationships with industry. In some cases, payments from drugmakers went undisclosed even though researchers were obliged to report them to their universities.
- read the JAMA extract
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Tags: American Psychiatric Association, APA, conflicts of interest, disclosures, Drug companies, ethics cleanup, National Institute of Mental Health, NIMH, pharmaceutical funding, pharmaceutical industry, Physician Payments Sunshine Act, psychiatrists, psychiatry, Senator Charles Grassley, Thomas Insel, top psychiatrist
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Tuesday, March 23rd, 2010
Associated Press
Carla K. Johnson
March 23, 2010
American psychiatrists need to break away from a “culture of influence” created by their financial dealings with the drug industry, the head of the National Institute of Mental Health said in a leading medical journal.
Dr. Thomas Insel stops short of calling researchers corrupt or asking them to stop taking money from drug companies. But he highlights a “bias in prescribing practices” that favors brand names drugs over cheaper generics and non-drug treatments. And he says the situation must change with new standards for transparency and full disclosure of psychiatry’s collaborations with industry.
“We can show the rest of medicine how to clean up our act,” Insel told The Associated Press. His commentary appears in Wednesday’s Journal of the American Medical Association.
His efforts got a boost Tuesday with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the “sunshine” provision because it also requires a database the public can search for their own doctors’ ties to industry.
“Transparency is the first step toward giving patients and the public the tools they need to evaluate those relationships,” said Allan Coukell, director of the Pew Prescription Project, a consumer health project of the nonprofit Pew Charitable Trusts.
Current National Institutes of Health rules on financial disclosure are confusing, Insel said. They allow researchers seeking federal funds to make their own judgments about what constitutes a significant financial interest, which they must report to their academic or research institutions. The rules also exempt disclosures of anything below $10,000 annually or 5 percent equity interest in a company. Insel is helping oversee a revision of the NIH’s rules, which date back to 1995.
Industry pays for much of the medical research in the United States and many scientists have financial relationships with drug and device makers. Researchers at many institutions are expected to fully disclose those ties to their universities, to the NIH and to the medical journals that publish their research.
Beginning in 2008, an inquiry by Sen. Chuck Grassley, R-Iowa, uncovered millions of dollars in unreported fees paid by drug industry to prominent researchers. The investigation prompted universities and NIH to reassess their conflict-of-interest policies.
When the Grassley inquiry accused seven psychiatrists of failing to report payments they received from drug companies, Insel, himself a psychiatrist, said he tried to determine whether psychiatrists were being targeted unfairly.
He found, instead, evidence that psychiatry may have more drug ties than other medical specialties. In Vermont, for example, which requires public disclosure of industry payments to doctors, psychiatrists receive more money from drug companies than do other types of doctors.
Psychiatric journals report slightly higher rates of industry funding of published studies than other medical journals. And one study found that 90 percent of the advisers who help write American Psychiatric Association guidelines had undisclosed financial ties to industry, Insel writes in JAMA.
Read entire article: http://www.google.com/hostednews/ap/article/ALeqM5i0eFhYRg8tB3fLeCNO4Ka1IXc_9wD9EKIA103
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Tags: American Psychiatric Association, APA, conflicts of interest, disclosures, Drug companies, ethics cleanup, National Institute of Mental Health, NIMH, pharmaceutical funding, pharmaceutical industry, Physician Payments Sunshine Act, psychiatrists, psychiatry, Senator Charles Grassley, Thomas Insel, top psychiatrist
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Saturday, February 20th, 2010
Pharmalot
By Ed Silverman
February 19, 2010
Grassley, who is the ranking Republican on the US Senate Finance Committee, is investigating the relationship between WebMD and drugmakers after learning the web site is running a TV ad that encourage people to take a depression-screening test sponsored by Eli Lilly, which sells Cymbalta.
So he wants WebMD, which lots of folks visit for medical info, to disclose its ties to the industry, in general, because the Lilly sponsorship raises questions about WebMD’s “independence,” according to this Feb. 18 letter to WebMD exec Wayne Gattinella. The ad encourages people to visit WebMD’s site to take a depression-screening test.
Read entire article: http://www.pharmalot.com/2010/02/grassley-probes-webmd-ties-to-eli-lilly/
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Tags: conflicts of interest, Cymbalta, Eli Lilly, screening, Senator Charles Grassley, US Senate Finance Committee, WebMD
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