cmpi ctr med public interest
<div><font face="Times New Roman" size="4">=</font></div><div><font face="Times New Roman" size="4">
</font></div><div><font face="Times New Roman" size="4">oops disambig</font></div><div><font face="Times New Roman" size="4">
</font></div><div><p style="margin-top: 8px; margin-bottom: 8px;"><font size="4" face="Times New Roman"></font></p><p style="margin-top: 8px; margin-bottom: 8px;"><span style="background-color: rgb(255, 153, 0);"><font size="4" face="Times New Roman">CRIMES</font></span></p><p style="margin-top: 8px; margin-bottom: 8px;"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px;"><a href="https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report" style="text-decoration-line: none; font-weight: bold; outline: none;"><font size="4" face="Times New Roman" color="#000000">https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report</font></a></p><p style="margin-top: 8px; margin-bottom: 8px;"><font size="4" face="Times New Roman">very long </font></p><p style="margin-top: 8px; margin-bottom: 8px;"><font size="4" face="Times New Roman">...a<strong style="box-sizing: border-box; background-color: rgb(248, 249, 244);">vandia:</strong><span style="background-color: rgb(248, 249, 244);"> In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.</span></font></p><p style="margin-top: 8px; margin-bottom: 8px;"><span style="background-color: rgb(248, 249, 244);"><font size="4" face="Times New Roman">
</font></span></p><p style="margin-top: 8px; margin-bottom: 8px;"><span style="background-color: rgb(248, 249, 244);"><font size="4" face="Times New Roman">all: </font></span></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">FOR IMMEDIATE RELEASE</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">Monday,<b> July 2, 2012</b></font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data</b></font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman" style="background-color: rgb(255, 255, 102);">Largest Health Care Fraud Settlement in U.S. History</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman" style="background-color: rgb(255, 153, 0);">Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay <b>$3 billion to resolve its criminal and civil liability</b> arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin,</b> into interstate commerce and<span style="background-color: rgb(255, 153, 0);"> one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA</span>). <span style="background-color: rgb(255, 255, 51);">Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.</span></font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil</b>, Wellbutrin and <span style="background-color: rgb(255, 255, 0);">Avandia</span>, as well as additional drugs, and also resolves pricing fraud allegations.</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said James M. Cole, Deputy Attorney General. “At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">“Today’s historic settlement is a major milestone in our efforts to stamp out health care fraud,” said Bill Corr, Deputy Secretary of the Department of Health and Human Services (HHS). “For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.”</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">This resolution marks the culmination of an extensive investigation by special agents from <b>HHS-OIG, FDA and FBI, </b>along with law enforcement partners across the federal government. Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse. Effective law enforcement partnerships and fraud prevention are hallmarks of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaboration to fight fraud. </font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>Criminal Plea Agreement</b></font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">Under the provisions of the Food, Drug and Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug. After the FDA approves the product as safe and effective for a specified use, a company’s promotional activities must be limited to the intended uses that FDA approved. In fact, promotion by the manufacturer for other uses – known as “off-label uses” – renders the product “misbranded.”</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>Paxil</b>: In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">Wellbutrin: The United States also alleges that, from January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. The United States contends that GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wllbutrin for these unapproved uses. GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses. For the Paxil and Wellbutrin misbranding offenses, GSK has agreed to pay a criminal fine and forfeiture of $757,387,200.</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><span style="background-color: rgb(255, 153, 0);"><b>Avandia: </b>The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends.</span><b> The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to<span style="background-color: rgb(255, 255, 51);"> pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia</span>.</b></font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">“This case demonstrates our continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or improper financial inducements,” said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">“Patients rely on their physicians to prescribe the drugs they need,” said John Walsh, U.S. Attorney for Colorado. “The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs. This case will help to ensure that your physician will make prescribing decisions based on good science and not on misinformation, money or favors provided by the pharmaceutical industry.”</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman">
</font></p><p style="margin-top: 8px; margin-bottom: 8px; background-color: rgb(255, 255, 255);"><font size="4" face="Times New Roman"><b>Civil Settlement Agreement...</b></font></p></div><div><font face="Times New Roman" size="4"></font></div><div><font face="Times New Roman" size="4"><a href="https://www.ucsusa.org/resources/glaxosmithkline-tried-silence-scientist-who-exposed-dangers-its-drug-avandia">https://www.ucsusa.org/resources/glaxosmithkline-tried-silence-scientist-who-exposed-dangers-its-drug-avandia</a></font></div><div><font face="Times New Roman" size="4">
</font></div><div><font face="Times New Roman" size="4">oct 2017</font></div><div><font face="Times New Roman" size="4">
</font></div><div><font face="Times New Roman" size="4">w</font><span style="font-family: inherit; font-size: inherit; font-style: inherit; font-variant-ligatures: inherit; font-variant-caps: inherit; font-weight: inherit; letter-spacing: -0.001em; color: var(--text-color);">hen Dr. John Buse found that a diabetes drug had the side effect of higher risk of heart disease, GlaxoSmithKline officials threatened his integrity and career.</span></div><div class="column-section" style="border: 0px; font-variant-numeric: inherit; font-variant-east-asian: inherit; font-stretch: inherit; font-size: 20px; line-height: inherit; font-family: UCSMercury, " mercury="mercury" ssm="ssm" a="a" b="b" georgia="Georgia" serif="serif" margin="margin" px="px" padding="padding" box-sizing="box-sizing" inherit="inherit"><div class="main-region" style="border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; margin: 0px; padding: 0px; box-sizing: inherit;"><div class="block block-layout-builder block-field-blocknoderesourcefield-sections" style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border-width: 0px; border-style: initial; border-color: var(--border-color); border-image: initial; margin: 0px; padding: 0px; box-sizing: inherit; color: var(--text-color);"><div class="field field--name-field-sections field--type-entity-reference-revisions field--label-hidden fielditems" style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px; padding: 0px; box-sizing: inherit;"><div class="fielditem" style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px; padding: 0px; box-sizing: inherit;"><div class="paragraph paragraph--type--text-section paragraph--view-mode--default clearfix" style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px auto; padding: 2rem 1rem 1.5rem; box-sizing: inherit; clear: both; position: relative; width: 640px; max-width: 32rem;"><div class="field field--name-field-callout field--type-entity-reference-revisions field--label-hidden fielditem" style="font: inherit; background-color: var(--bg-color); border: 0px; margin: 0px -8rem 1rem 1rem; padding: 0px; box-sizing: inherit; float: right; max-width: 16rem;"><div class="paragraph paragraph--type--node-callout paragraph--view-mode--default" style="border: 0px; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit;"><div class="field field--name-field-related-content field--type-entity-reference field--label-hidden fielditem" style="border: 0px; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit;"><article role="article" class="node node--type-resource node--view-mode-teaser" style="border: 0px; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit;"><a href="https://www.ucsusa.org/resources/disinformation-playbook" class="img-wrapper" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none; display: block;" /><div class="field field--name-field-resource-type field--type-list-string field--label-hidden fielditem" style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 0.6rem; line-height: inherit; font-family: UCSGotham, " gotham="gotham" ssm="ssm" a="a" b="b" trebuchet="trebuchet" ms="ms" sans-serif="sans-serif" margin="margin" px="px" padding="padding" em="em" box-sizing="box-sizing" inherit="inherit" text-color="text-color" fff="fff" bg-color="bg-color" border-color="border-color" muted-color="muted-color" ccc="ccc" position="position" absolute="absolute" z-index="z-index" text-transform="text-transform" uppercase="uppercase" background-color="background-color" var="var" letter-spacing="letter-spacing" color="color"><a href="https://www.ucsusa.org/resources/disinformation-playbook" class="img-wrapper" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none; display: block;" /><a href="https://www.ucsusa.org/resources/disinformation-playbook" class="img-wrapper" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none; display: block;" /><a href="https://www.ucsusa.org/resources/disinformation-playbook" class="img-wrapper" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none; display: block;" /><a href="https://www.ucsusa.org/resources/disinformation-playbook" class="img-wrapper" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none; display: block;">FEATURE</a></div><div class="field field--name-field-thumbnail-image field--type-entity-reference field--label-hidden fielditem" style="border: 0px; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit;"><figure class="media media--type-image media--view-mode-standard-medium" style="border: 0px; font: inherit; margin: 0px auto; padding: 0px; box-sizing: inherit; max-width: 100%; height: auto; position: relative;"><div class="field field--name-field-media-image field--type-image field--label-hidden fielditem" style="border: 0px; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit;">
</div><figcaption style="border: 0px; font-style: italic; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 0.75rem; line-height: 1.53333; font-family: inherit; margin: 0px; padding: 0px; box-sizing: inherit; color: var(--muted-color);" /></figure></div><h3 style="border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: 1rem; line-height: 1.23077; font-family: inherit; margin: 0.5em 0px 0.25em; padding: 0px; box-sizing: inherit; letter-spacing: -0.002em;"><a href="https://www.ucsusa.org/resources/disinformation-playbook" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: transparent; border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none;">The Disinformation Playbook</a></h3><div class="field field--name-field-description field--type-string field--label-hidden fielditem" style="border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 0.75rem; line-height: 1.53333; font-family: inherit; margin: 0px; padding: 0px; box-sizing: inherit; color: var(--muted-color);">Five tactics business interests use to sideline science, deceive the public and buy influence at the expense of public health and safety.</div></article></div></div></div><div class="field field--name-field-text field--type-text-long field--label-hidden field__item" style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px; padding: 0px; box-sizing: inherit;"><p style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="font-weight: inherit;">In<span style="background-color: rgb(255, 255, 51);"> July 2010, an FDA advisory committee recommended a recall of Avandia, a drug used to treat Type-2 diabetes, and placed severe restrictions on its availability</span>. G</span><b>laxoSmithKline, Avandia’s manufacturer, had long known about the drug’s potentially life-threatening side effects. But the company used its power to silence scientists rather than protecting its customers by bringing the harm to light</b><span style="font-weight: inherit;">.</span></p><p style="font: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="background-color: var(--bg-color);">A decade earlier, in 1999, Dr. John Buse at the University of North Carolina found that Avandia users had a high risk of heart disease, and published his findings. In response, </span><span style="background-color: rgb(255, 255, 0);">Buse alleges, a representative from the company contacted his boss, accused him of lying, and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1892463/" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; text-decoration-line: none;">threatened to sue him</a> for a $4 billion drop in the company’s stock valuation.</span></p><p style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="font-weight: inherit; background-color: rgb(255, 255, 51);">A Senate Finance Committee report confirmed Buse’s charges, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2099503/" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; text-decoration-line: none;">revealing</a> that a GlaxoSmithKline official emailed Tadataka Yamada, then the company’s chairman of research and development, urging him to write a “firm letter” to Buse. It would contain a warning that “the punishment will be that we will complain up his academic line and to the CME [continuing medical education] granting bodies that accredit his activities</span><span style="background-color: var(--bg-color);"><span style="font-weight: inherit;">.” Yamada wrote back, “I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well-planned offensive on behalf of Avandia.” </span><b>Yamada also called Fred Sparling, the chairman of Buse's department at UNC, and communicated the threat of lawsuits</b><span style="font-weight: inherit;">.</span></span></p><p style="font: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="background-color: rgb(255, 153, 0);">After this blatant harassment, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2099503/" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; text-decoration-line: none;">Buse felt</a> he had no choice but to sign a letter drafted by the company which walked back his scientific findings</span><span style="background-color: var(--bg-color);">. It stated that his comments on the drug “had been taken out of context” and that “only years of use, greater patient exposure and comparative clinical trials” would provide the data needed to allow any drug “into proper perspective.” </span><span style="background-color: rgb(255, 153, 0);">The letter was used by the industry to persuade financial analysts to change their safety assessment of Avandia, which resulted in its staying on the market another decade.</span></p><p style="font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="font-weight: inherit; background-color: rgb(255, 204, 102);">In 2007, a <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa072761" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; text-decoration-line: none;">meta-analysis</a> of 42 randomized controlled trials of the drug confirmed Buse’s findings and revealed that there was a 43 percent increase in the risk of heart disease among diabetics taking Avandia. </span><span style="background-color: var(--bg-color);"><span style="font-weight: inherit;">When questioned on its intimidation of Buse by the </span><a href="https://www.finance.senate.gov/imo/media/doc/prb111507a.pdf" style="font: inherit; border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none;">Senate Finance Committee in 2007</a><span style="font-weight: inherit;">, GlaxoSmithKline released </span><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2099503/" style="font: inherit; border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none;">a statement</a><span style="font-weight: inherit;"> saying, </span><b>“perhaps we could have handled interactions with Dr. Buse better,” but otherwise denied that it had retaliated against the scientist</b><span style="font-weight: inherit;">. After reviewing extensive documents from Buse, the Committee concluded that the behavior of the company was “troubling” and “had Buse been able to continue voicing his concerns, without being characterized as a ‘renegade’ and without the need to sign a ‘retraction letter,’ it appears that the public good would have been better served.”</span></span></p><p style="font: inherit; border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.001em;"><span style="background-color: rgb(255, 153, 0);">Ultimately, this case—including the ultimate corroboration of Buse’s findings—spawned thousands of lawsuits charging that GlaxoSmithKline’s handling of the drug caused death and illness in patients. The company has already paid at least $90 million to settle some of them.</span></p><h2 style="font-weight: inherit; background-color: var(--bg-color); border: 0px; font-style: inherit; font-variant: inherit; font-stretch: inherit; font-size: 1.8rem; line-height: 1.16667; font-family: inherit; margin: 1rem 0px 1.6rem; padding: 0px; box-sizing: inherit; letter-spacing: -0.002em;">Further Reading</h2><ul style="font: inherit; background-color: var(--bg-color); border: 0px; margin: 0px 0px 1.6rem; padding: 0px; box-sizing: inherit; list-style-position: initial; list-style-image: initial;"><li style="border: 0px; font: inherit; margin: 0px 0px 0.5em 2rem; padding: 0px; box-sizing: inherit; list-style: none;"><a href="https://www.ucsusa.org/sites/default/files/legacy/assets/documents/scientific_integrity/how-corporations-corrupt-science.pdf" style="border-width: 0px 0px 2px; border-top-style: initial; border-right-style: initial; border-bottom-style: solid; border-left-style: initial; border-top-color: initial; border-right-color: initial; border-bottom-color: rgb(0, 174, 235); border-left-color: initial; border-image: initial; font: inherit; margin: 0px; padding: 0px; box-sizing: inherit; background-color: transparent; text-decoration-line: none;">How Corporations Corrupt Science at the Public’s Expense</a></li></ul></div></div></div></div></div></div></div><h3><font size="4" face="Times New Roman">=</font></h3><h3><font size="4" face="Times New Roman">Avandia controversy</font></h3><font face="Times New Roman" size="4"><font face="Times New Roman" /></font><p><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman" size="4"><font face="Times New Roman"><font face="Times New Roman"><font face="Times New Roman"><font face="Times New Roman"><font face="Times New Roman">Following Dr. Steven Nissen's publication of a study warning that "<b>GlaxoSmithKline's diabetes drug <a href="http://www.sourcewatch.org/index.php/Avandia" title="Avandia">Avandia</a> increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%,"</b> he was publicly pilloried. "More than one story from ostensibly different sources" derisively referred to him as "St Steven," the "Patron Saint of Drug Safety," and "Saint Steven the Pure," reported Evelyn Pringle in an August of 2007 <a href="http://www.sourcewatch.org/index.php/Counterpunch" title="Counterpunch">CounterPunch</a> article.<sup id="cite_ref-13" class="reference"><a href="http://www.sourcewatch.org/index.php/GlaxoSmithKline#cite_note-13">[14]</a></sup></font></font></font></font></font></font></font></font></font></font></font></font></p><p><font face="Times New Roman"> </font></p><p><font face="Times New Roman">Among the Nissen attackers was <a href="http://www.sourcewatch.org/index.php/Food_and_Drug_Administration" title="Food and Drug Administration" class="mw-redirect">Food and Drug Administration</a> (FDA) spokesman <a href="http://www.sourcewatch.org/index.php?title=Douglas_Arbesfeld&action=edit&redlink=1" class="new" title="Douglas Arbesfeld (page does not exist)">Douglas Arbesfeld</a>. Arbesfeld previously worked for the <a href="http://www.sourcewatch.org/index.php/Public_relations" title="Public relations">public relations</a> firm <a href="http://www.sourcewatch.org/index.php/Manning_Selvage%26_Lee" title="Manning Selvage & Lee" class="mw-redirect">Manning Selvage & Lee</a> (MS&L), helping Glaxo and other "healthcare clients maximize internet-relations."<span style="background-color: rgb(255, 153, 0);"> Former FDA Deputy Commissioner Dr. <a href="http://www.sourcewatch.org/index.php/Scott_Gottlieb" title="Scott Gottlieb">Scott Gottlieb</a>, who ridiculed Nissen in a <a href="http://www.sourcewatch.org/index.php/Wall_Street_Journal" title="Wall Street Journal">Wall Street Journal</a> editorial, also consulted for pharmaceutical companies at MS&L</span>. Two more FDA alums, <a href="http://www.sourcewatch.org/index.php/Peter_Pitts" title="Peter Pitts">Peter Pitts</a> and <a href="http://www.sourcewatch.org/index.php/Robert_Goldberg" title="Robert Goldberg">Robert Goldberg</a>, mocked Nissen in a <a href="http://www.sourcewatch.org/index.php/Washington_Times" title="Washington Times">Washington Times</a> piece. Pitts is the senior vice-president for global health affairs at MS&L. Goldberg doesn't have ties to the PR firm, but serves with Pitts as an officer of the <span style="background-color: rgb(255, 153, 0);"><a href="http://www.sourcewatch.org/index.php/Center_for_Medicine_in_the_Public_Interest" title="Center for Medicine in the Public Interest">Center for Medicine in the Public Interest</a> (CMPI</span>), which Pringle describes as a "nest of ex-moles who served the industry in one capacity or another in the <a href="http://www.sourcewatch.org/index.php/Bush_Administration" title="Bush Administration" class="mw-redirect">Bush Administration</a>'s FDA."<sup id="cite_ref-14" class="reference"><a href="http://www.sourcewatch.org/index.php/GlaxoSmithKline#cite_note-14">[15]</a></sup></font></p><p><font face="Times New Roman"> </font></p><p><font face="Times New Roman"><b>CMPI is a project of the </b><a href="http://www.sourcewatch.org/index.php/Pacific_Research_Institute" title="Pacific Research Institute"><b>Pacific Research Institute</b></a><b>, a free market </b><a href="http://www.sourcewatch.org/index.php/Think_tank" title="Think tank" class="mw-redirect"><b>think tank</b></a><b>.</b></font></p><p><font face="Times New Roman">See also <a href="http://www.sourcewatch.org/index.php/GlaxoSmithKline,the_Diabetes_Drug_Avandia_and_The_Intimidation_of_Dr._John_Buse" title="GlaxoSmithKline, the Diabetes Drug Avandia and The Intimidation of Dr. John Buse">GlaxoSmithKline, the Diabetes Drug Avandia and The Intimidation of Dr. John Buse</a></font></p><p>
</p><p>=</p><p>brochure?</p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">The Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.</p><h3 style="background: none rgb(255, 255, 255); margin: 0.3em 0px 0px; overflow: hidden; padding-top: 0.5em; padding-bottom: 0px; border-bottom: 0px; line-height: 1.6;"><span class="mw-headline" id="Founders">Founders</span></h3><ul style="margin: 0.3em 0px 0.5em 1.6em; padding: 0px; list-style-image: url(" data:image="data:image" svg="svg" xml="xml" csvg="Csvg" width="%225%22" height="%2213%22%3E" ccircle="Ccircle" cx="%222.5%22" cy="%229%22" r="%222.5%22" fill="%22%23222%22/%3E" c="C" e="E" background-color="background-color" rgb="rgb" xmlns="%22http://www.w3.org/2000/svg%22" xmlns:data="data"><li style="margin-bottom: 0.1em;"><a href="https://www.sourcewatch.org/index.php?title=Peter_Pitts" title="Peter Pitts" style="text-decoration-line: none; background: none;">Peter Pitts</a> Peter Pitts</li></ul><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest Prior to founding CMPI, Pitts was a <b>Senior Fellow for healthcare studies at the Pacific Research Institute.</b></p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);"><b>From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations,</b> serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce.</p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">His book, Become Strategic or Die, is widely recognized as a cutting edge study of how leadership, in order to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of the new book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting.</p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University. <a rel="nofollow" class="external free" href="http://cmpi.org/about-us/founders/peter-pitts/" style="text-decoration-line: none; background: linear-gradient(transparent, transparent) right center no-repeat, url(" data:image="data:image" svg="svg" xml="xml" csvg="Csvg" width="%2212%22" height="%2212%22%3E" cpath="Cpath" fill="%22%23fff%22" stroke="%22%2336c%22" d="%22M9.995" h5.982v10.5h1.5z="h5.982V10.5H1.5z" e="E" h11v5.39l9.427="H11v5.39L9.427" l-1.31-1.31l5.393="l-1.31-1.31L5.393" l-2.69-2.688="l-2.69-2.688" l4.2="L4.2" z="z" l.022="l.022" l8.2="L8.2" l2.882-2.88-1.85-1.852z="l2.882-2.88-1.85-1.852z" c="C" padding-right="padding-right" px="px" overflow-wrap="overflow-wrap" break-word="break-word" xmlns="%22http://www.w3.org/2000/svg%22" xmlns:data="data">http://cmpi.org/about-us/founders/peter-pitts/</a></p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">
</p><ul style="margin: 0.3em 0px 0.5em 1.6em; padding: 0px; list-style-image: url(" data:image="data:image" svg="svg" xml="xml" csvg="Csvg" width="%225%22" height="%2213%22%3E" ccircle="Ccircle" cx="%222.5%22" cy="%229%22" r="%222.5%22" fill="%22%23222%22/%3E" c="C" e="E" background-color="background-color" rgb="rgb" xmlns="%22http://www.w3.org/2000/svg%22" xmlns:data="data"><li style="margin-bottom: 0.1em;"><a href="https://www.sourcewatch.org/index.php?title=Robert_Goldberg" title="Robert Goldberg" style="text-decoration-line: none; background: none;">Robert Goldberg</a>, Robert M. Goldberg, PhD</li></ul><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest. (CMPI) <b>Along with Peter Pitts, Dr. Goldberg hosts the popular and controversial blog on the pharmaceutical industry and healthcare, www.drugwonks.com.</b></p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">Prior to founding CMPI, Goldberg was Director of the <b>Manhattan Institute’</b>s Center for Medical Progress and Chairman of its 21st Century FDA Task Force that examined the impact of the FDA’s Critical Path Initiative on drug development and personalized medicine.</p><p style="margin: 0.5em 0px; line-height: inherit;"><span style="background-color: rgb(255, 255, 51);">He has written for The Wall Street Journal, The Washington Post, the Los Angeles Times, National Review Online, The Chicago Tribune, The Philadelphia Inquirer, The New York Sun and writes regularly for The American Spectator (</span><span style="background-color: rgb(255, 255, 255);">where he broke the story about Obama Medicare director Donald Berwick’s admiration for Britain’s National Health Service); the New York Post and The Weekly Standard. He is an expert on Medicare reform, comparative effectiveness and FDA’s Critical Path Initiative and the author of many papers including, "Insta-Americans: The Empowered (and Imperiled) Health Care Consumer in the Age of Internet Medicine," and with John Vernon, "Alzheimer's Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money?" and “Economic Evaluation and Comparative-Effectiveness Thresholds: Signals to Firms and Implications for R&D Investment and Innovation.” He is also author of the forthcoming book, “Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit.” (Kaplan, December 2010).</span></p><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);"><a rel="nofollow" class="external free" href="http://cmpi.org/about-us/founders/robert-goldberg/" style="text-decoration-line: none; background: linear-gradient(transparent, transparent) right center no-repeat, url(" data:image="data:image" svg="svg" xml="xml" csvg="Csvg" width="%2212%22" height="%2212%22%3E" cpath="Cpath" fill="%22%23fff%22" stroke="%22%2336c%22" d="%22M9.995" h5.982v10.5h1.5z="h5.982V10.5H1.5z" e="E" h11v5.39l9.427="H11v5.39L9.427" l-1.31-1.31l5.393="l-1.31-1.31L5.393" l-2.69-2.688="l-2.69-2.688" l4.2="L4.2" z="z" l.022="l.022" l8.2="L8.2" l2.882-2.88-1.85-1.852z="l2.882-2.88-1.85-1.852z" c="C" padding-right="padding-right" px="px" overflow-wrap="overflow-wrap" break-word="break-word" xmlns="%22http://www.w3.org/2000/svg%22" xmlns:data="data">http://cmpi.org/about-us/founders/robert-goldberg/</a></p><h2 style="background: none rgb(255, 255, 255); font-weight: normal; margin: 1em 0px 0.25em; overflow: hidden; padding: 0px; border-bottom: 1px solid rgb(162, 169, 177); line-height: 1.3;"><span class="mw-headline" id="Contact_details">Contact details</span></h2><p style="margin: 0.5em 0px; line-height: inherit; background-color: rgb(255, 255, 255);">308 East 38th Street
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