Pharmaceutical Corruption Media Articles

Excerpts of Key Pharmaceutical Corruption Media Articles in Major Media

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Almost 30 key lawmakers helping draft landmark health-care legislation have financial holdings in the industry, totaling nearly $11 million worth of personal investments in a sector that could be dramatically reshaped by this summer's debate. The list of members who have personal investments in the corporations that will be affected by the legislation -- which President Obama has called this year's highest domestic priority -- includes Congress's most powerful leaders and a bipartisan collection of lawmakers in key committee posts. Their total health-care holdings could be worth $27 million, because congressional financial disclosure forms released yesterday require reporting of only broad ranges of holdings rather than precise values of assets. Senate Majority Leader Harry M. Reid (D-Nev.), for instance, has at least $50,000 invested in a health-care index, and Sen. Judd Gregg (R-N.H.), a senior member of the health committee, has between $254,000 and $560,000 worth of stock holdings in major health-care companies, including Bristol-Myers Squibb and Merck. The family of Rep. Jane Harman (D-Calif.), a senior member of the House Energy and Commerce Committee drafting that chamber's legislation, held at least $3.2 million in more than 20 health-care companies at the end of last year. "If someone is going to be substantially enriched by the consequences of the vote, particularly if it represents a meaningful amount of their net worth, then there is a problem," said Harlan Krumholz, a professor of medicine at Yale University.

Note: For more powerful information on major corruption in health care reform, click here. For lots more on government corruption from reliable, verfiiable sources, click here.

For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death. Now the new leadership at the F.D.A. may change that. The Obama administration ... is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study. The goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers. “Many people have been harmed over the last decade because the F.D.A. has treated clinical trial results of drugs and devices as trade secrets,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information. In 2007, Dr. Nissen published a study showing that Avandia, a popular diabetes medicine made by GlaxoSmithKline, increased the risk of heart attack by 42 percent. The data Dr. Nissen used was made public because of a lawsuit, but the agency had known of the possible risk for nearly two years. Repeated scandals led the Bush administration in 2005 to promise to make public its product safety investigations more quickly, but it did not recommend changing the laws and regulations that govern the release of trade secrets and agency records.

Note: For a powerful summary of corrupt practices by government and corporations in the pharmaceutical industry, click here.

A fascinating court case in Australia has been playing out around some people who had heart attacks after taking the Merck drug, Vioxx. This medication turned out to increase the risk of heart attacks in people taking it, although that finding was arguably buried in their research, and Merck has paid out more than Ł2bn to 44,000 people in America. The first ... thing to emerge in the Australian case is email documentation showing staff at Merck made a "hit list" of doctors who were critical of the company, or of the drug. This list contained words such as "neutralise", "neutralised" and "discredit" next to the names of various doctors. "We may need to seek them out and destroy them where they live," said one email, from a Merck employee. Staff are also alleged to have used other tactics, such as trying to interfere with academic appointments, and dropping hints about how funding to institutions might dry up. Worse still, is the revelation that Merck paid the publisher Elsevier to produce a publication. This time Elsevier Australia went the whole hog, giving Merck an entire publication which resembled an academic journal, although in fact it only contained reprinted articles, or summaries, of other articles.

Note: For a superb overview of corruption in the pharmaceutical industry by a leading MD and former medical journal editor, click here.

Pharmaceutical stocks are skyrocketing on fears that a swine flu outbreak could go global. Manufacturers of antiviral drugs [and] companies gearing up to produce a vaccine ... are turning profits in an otherwise skittish and down market. Companies gearing up for swine flu, including Roche, Gilead Sciences and GlaxoSmithKline, the manufacturers of the leading antiviral flu medications, are best positioned to see a boost in profits if the disease escalates to epidemic proportions, analysts said. Tamiflu ... was developed by Gilead and manufactured by Roche. Both companies' share prices spiked soon after the U.S. government allowed for its stockpiles of the drug to be made publicly available. Gilead stock surged to $47.53 at the end of the day Monday, up 3.78 percent. Roche rose to $31.72, up 4.34 percent. The other major flu drug currently on the market is Relenza, also stockpiled and released by the government, and manufactured by GlaxoSmithKline. Shares of Glaxo closed surged Monday to $31.56, up 7.57 percent. Both Tamiflu and Relenza are stockpiled by governments and in the case of an outbreak the companies are often required to sell the drugs directly to the government at a discount. "Government stockpiling is viewed as boon for profits. Though the government gets a discount and the margins sold to the government are lower than those if they sold to Walgreens, from a stock perspective it's an unexpected positive surprise," he said.

Note: Pharmaceutical companies make big bucks from scares like the avian flu and swine flu. Yet are the recommended drugs really effective? Many studies say they are not. For analysis of profiteering by the pharmaceutical industry during a previous flu scare, click here. See this link for lots more.

Federal prosecutors in the U.S. will be reading with amusement the Australian press's coverage of a class action trial down under for patients who took Merck's now-withdrawn painkiller Vioxx. Details emerging in Oz make some of the antics that Merck's American counterparts got up to look tame by comparison. For example, in Australia, Merck allegedly: Had a doctor sign his name to an entirely ghostwritten journal article even though a Merck staffer had complained that the data within it was based on "wishful thinking;" created a fake "peer-reviewed" journal, the "Australasian Journal of Bone and Joint Medicine," in which to publicize pro-Vioxx articles; created a Ricky Martin-style pop song to get Merck sales reps all jazzed up about Vioxx; [and] hatched a Blackadder-style "cunning plan" to seed seminars with speakers who were sympathetic to Vioxx. Here's The Australian's description of the Merck PR team's over-the-top "handling" of reporters at ... a class action trial down under for patients who took Merck's now-withdrawn painkiller Vioxx: A hired crisis management team sits in court every day, under the guidance of Merck & Co's media spokeswoman flown out from the US, watching what journalists write, who they talk to and where they go in the court breaks. The team ... follow journalists out of court, ask them what they are writing, hand out daily press releases and send "background" emails they say should not be attributed to the company but which detail what they think are the "salient points" from the evidence presented in court. The team rings reporters first thing in the morning, accuses them of "cherry-picking" the evidence and bombards newspapers with letters to the editor arguing their case in detail based on the day's evidence - five were sent to The Australian in just seven days.

Note: FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market. Read another CBS News article which shows how Merck literally created a hit list for doctors who opposed use of Vioxx. For more along these lines, see concise summaries of deeply revealing health corruption news articles from reliable major media sources.

An international drug company made a hit list of doctors who had to be "neutralised" or discredited because they criticised the anti-arthritis drug the pharmaceutical giant produced. Staff at US company Merck &Co emailed each other about the list of doctors - mainly researchers and academics - who had been negative about the drug Vioxx or Merck and a recommended course of action. The email, which came out in the Federal Court in Melbourne yesterday as part of a class action against the drug company, included the words "neutralise", "neutralised" or "discredit" against some of the doctors' names. It is also alleged the company used intimidation tactics against critical researchers, including dropping hints it would stop funding to institutions and claims it interfered with academic appointments. "We may need to seek them out and destroy them where they live," a Merck employee wrote, according to an email excerpt read to the court by Julian Burnside QC, acting for the plaintiff. Merck & Co and its Australian subsidiary, Merck, Sharpe and Dohme, are being sued for compensation by more than 1000 Australians, who claim they suffered heart attacks or strokes as a result of Vioxx. The drug was launched in 1999 and at its height of popularity was used by 80 million people worldwide because it did not cause stomach problems as did traditional anti-inflammatory drugs. It was voluntarily withdrawn from sale in 2004 after concerns were raised that it caused heart attacks and strokes and a clinical trial testing these potential side affects was aborted for safety reasons. Merck last year settled thousands of lawsuits in the US over the effects of Vioxx for $US 4.85 billion, but made no admission of guilt.

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Dr. Joseph Biederman, chief of the Massachusetts General Pediatric Psychopharmacology Clinic, is already under investigation by Harvard University and the National Institutes of Health for failing to report income received from drug companies. Biederman has strongly pushed treating children's mental illnesses with powerful antipsychotic medicines. Diagnoses like ADHD and pediatric bipolar disorder, along with psychiatric drug use in American children, have soared in the last 15 years. No other country medicates children as frequently. Now, in newly released court documents, Biederman appears to be promising drugmaker Johnson & Johnson in advance that his studies on the antipsychotic drug risperidone will prove the drug to be effective when used on preschool age children. Biederman's status at Harvard and his research have arguably made him, until recently, America's most powerful doctor in child psychiatry. Reports from court actions, along with an ongoing investigation of conflict of interest charges led by Sen. Chuck Grassley, R-Iowa, threaten to topple Biederman from his heretofore untouchable Olympian heights. Biederman's conflict of interest problems have exposed his strong pro-drug views to the public for scrutiny. Until now, fear of the Biederman team has operated quietly on the small club of child psychiatric researchers. Only when 2-year-olds started taking three psychiatric drugs simultaneously under a Biederman protocol for bipolar disorder did the emperor's clothes become so invisible as to begin the naming of names. Biederman's personal travails tragically inform us about a crisis in academic medicine that must be resolved.

Note: For a powerful overview of corruption in the pharmaceutical industry, click here.

It's not often that a place like Harvard Medical School gets an F – particularly when rivals Stanford, Columbia and the University of Pennsylvania are pulling A's and B's. But that's what happened recently when the members of the increasingly influential – and increasingly noisy – American Medical Student Association (AMSA) decided to grade 150 med schools on just how much money and gifts they're collecting from drug companies. The more goodies a school is vacuuming up from the industry, the worse its grade. It turns out that many professors and instructors are, legally, on the dole as well, and students are beginning to worry that what they're being taught is just as one-sided as what patients are being prescribed. Harvard, at the moment, is at the center of it. Of Harvard's 8,900 professors and lecturers, 1,600 admit that either they or a family member have had some kind of business link to drug companies – sometimes worth hundreds of thousands of dollars – that could bias their teaching or research. Additionally, pharma contributed more than $11.5 million to the school last year for research and continuing-education classes. And while Harvard might be the highest-profile name that was posted on AMSA's grade list, it was hardly the only one that flunked: 40 out of the 150 schools surveyed received F's; only 22 got an A or B. Harvard has convened a 19-member committee ... to review its pharma policy, though the university is hedging on whether it actually plans to change the way it operates.

Note: For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma corruption from reliable major media sources.

A special "vaccines court" hears cases brought by parents who claim their children have been harmed by routine vaccinations. The court buffers Wyeth and other makers of childhood-disease vaccines from ... litigation risk. The legal shield, known as the National Childhood Vaccine Injury Compensation Program, was put into place in 1986. Vaccines ... are poised to generate $21.5 billion in annual sales for their makers by 2012, according to France's Sanofi-Aventis SA, a leading producer of inoculations. Vaccines' transformation into a lucrative business has some observers questioning whether the shield law is still appropriate. Critics ... underscored the limited recourse families have in claiming injury from vaccines. "When you've got a monopoly and can dictate price in a way that you couldn't before, I'm not sure you need the liability protection," said Lars Noah, a specialist in medical technology. Kevin Conway, an attorney at Boston law firm Conway, Homer & Chin-Caplan PC, which specializes in vaccine cases and brought one of the recent autism suits, says the lack of liability for the pharmaceutical industry compromises safety. Even if they had won their cases, the families of autistic children wouldn't have been paid by the companies that make the vaccines. Instead, the government would have footed the bill, using the funds from a tax levied on inoculations.

Note: For more along these lines, see concise summaries of deeply revealing news articles on vaccines from reliable major media sources showing huge corruption and deception.

What are the pills in your medicine cabinet, and how do you know they're best for you? When drug companies seek approval to market new medicines, they must show the U.S. Food and Drug Administration the results of all the tests they've run on volunteer patients - at first on only a few, then on dozens, and finally on hundreds or sometimes thousands. After winning approval, the companies typically sponsor reports of those tests in medical journal publications, which many doctors often rely on to determine whether to prescribe new drugs for their patients. Now a skeptical team of medical investigators at UCSF has accused the major drug companies of bias by distorting the results of their trials in those publications, making it hard for doctors to judge for themselves the pros and cons of prescribing the new drugs. As a result, the researchers say, patients may sometimes be taking medicines they don't need - or with unwanted side effects - that their doctors have prescribed on the basis of inadequate information. The UCSF team, led by Lisa A. Bero of the medical center's Institute for Health Policy Studies, probed the details of 164 drug trials involving as many as 1,500 patients over a two-year period and then examined reports on those trials that were published in medical journals, as well as those that remained unpublished. "We found really important information from the official trial reports that were either not published at all or that stressed mostly the positive results of trials in the published versions," said Kristin Rising, a physician at the institute who did the major investigation.

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They're some of the most trusted voices in the defense of vaccine safety: the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr. Paul Offit. But CBS News has found these three have something more in common - strong financial ties to the industry whose products they promote and defend. The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters. The totals are kept secret, but public documents reveal bits and pieces. A $342,000 payment from Wyeth, maker of the pneumococcal vaccine - which makes $2 billion a year in sales. A $433,000 contribution from Merck, the same year the academy endorsed Merck's HPV vaccine - which made $1.5 billion a year in sales. Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too - but wouldn't tell us how much. Then there's Paul Offit, perhaps the most widely-quoted defender of vaccine safety. He's gone so far as to say babies can tolerate "10,000 vaccines at once." In fact, he's a vaccine industry insider. Offit holds a $1.5 million dollar research chair at Children's Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck. And future royalties for the vaccine were just sold for $182 million cash.

Note: An excellent report endorsed by many respected doctors and nurses reveals the serious risks of vaccines. Read an incisive list of questions regarding vaccines that are rarely raised by the media. The report accessible on this US government webpage states, "Since 1988, over 24,200 petitions have been filed with the VICP [Vaccine Injury Compensation Program] ... with 8,162 of those determined to be compensable. Total compensation paid over the life of the program is approximately $4.5 billion." Why isn't that huge price tag for vaccine injuries being talked about?

Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill. In 1996, for example, Biederman suggested that drugs like Ritalin might serve 10 percent of American kids for Attention Deficit Hyperactivity Disorder. By 2004, one in nine 11-year-old boys was taking the drug. Biederman and his team also are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs. The science of children's psychiatric medications is so primitive and Biederman's influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind - instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America. That's why [the] recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic. American medicine, with psychiatry the most culpable, has fallen back to a time more than 100 years ago. Now once again, drug company money is corrupting medical practice and the maintenance of our country's health. Virtually all doctors who receive drug company money say they are not influenced, but every independent study examining the effects of such money says they are.

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It seemed an ideal marriage, a scientific partnership that would attack mental illness from all sides. Psychiatrists would bring ... their expertise and clinical experience, drug makers would provide their products and the money to run rigorous studies, and patients would get better medications, faster. But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing. "I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said. In 2006 ... the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. One of the doctors named by Mr. Grassley is the association’s president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company raised the senator’s concern. Commercial arrangements are rampant throughout medicine. In the past two decades, drug and device makers have paid tens of thousands of doctors and researchers of all specialties. Worried that this money could taint doctors’ research plans or clinical judgment, government agencies, medical journals and universities have been forced to look more closely at deal details.

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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 ... 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?" Vioxx was a best-selling drug before Merck pulled it from the market in 2004 over evidence linking it to heart attacks. Last fall the company agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits. The lead author of Wednesday's article, Dr. Joseph S. Ross ... 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," Dr. Ross said, whose article ... was published Wednesday in JAMA, the journal of the American Medical Association. 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 magnitude of the practice.

Note: Vioxx may have been responsible for 500,000 premature deaths. For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma corruption from reliable major media sources.

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today. The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill. When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs. The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better. "Given these results, there seems little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed," says Kirsch. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported." The paper, published today in the journal PLoS (Public Library of Science) Medicine, is likely to have a significant impact on the prescribing of the drugs. The National Institute for Health and Clinical Excellence already recommends that counselling should be tried before doctors prescribe antidepressants.

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U.S. drug companies spend almost twice as much on marketing and promoting medications [as] on research and development, a new Canadian study says. "These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry's claim," the authors write in this week's peer-reviewed journal Public Library of Science Medicine. Using data from two market research companies, the University of Quebec's Marc-André Gagnon and York University's Joel Lexchin found U.S. drug companies spent $57.5 billion US on promotional activities in 2004 compared with $31.5 billion on research and development. Promotional activities included free samples, visits from drug reps, direct-to-consumer advertising of drugs, meetings with doctors to promote products, e-mail promotions, direct mail and clinical trials designed to promote the prescribing of new drugs rather than to generate scientific data. The authors say their figure of $57.5 billion US is likely an underestimate, citing other avenues for promotion such as ghostwriting of articles in medical journals by drug company employees, or the off-label promotion of drugs. Drug companies have long argued they are driven primarily by research, while critics charge that marketing and profits are their primary concerns. There were extensive U.S. government reviews of the pharmacy business in the 1950s and '60s and again in the 1980s. But there hasn't been a comprehensive study of drug industry profits and spending in more than a decade.

Note: For a powerful overview of corruption in the pharmaceutical industry, click here.

Three years after withdrawing its pain medication Vioxx from the market, Merck has agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking the drug. The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle. Based on the fact that the 27,000 suits cover about 47,000 sets of plaintiffs, the average plaintiff will receive just over $100,000 before legal fees and expenses, which usually swallow between 30 and 50 percent of payments to plaintiffs. Plaintiffs who do not want to accept the settlement can pursue their own claims, but with so many of the top trial lawyers in the United States agreeing to the deal, they may have difficulty doing so. The settlement does not end the government investigations that Merck faces, which include both civil and criminal inquires from several states and the Justice Department. But for Merck, which has already spent more than $1.2 billion on Vioxx-related legal fees, the settlement will put to rest any fears that Vioxx lawsuits might bankrupt the company, or even have a significant financial impact.

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The nation is at risk if FDA science is at risk. In recognition of this threat, in December 2006, FDA Commissioner Andrew von Eschenbach, MD requested that the Science Board, which is the Advisory Board to the Commissioner, form a Subcommittee to assess whether science and technology at the FDA can support current and future regulatory needs. This report is the product of that assessment. The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak. The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability. FDA does not have the capacity to ensure the safety of food for the nation. The FDA science agenda lacks a structure and vision, as well as effective coordination. The FDA has an inadequate and ineffective program for scientist performance. Recommendations of excellent FDA reviews are seldom followed.

Note: The above excerpts are all taken from the chapter headings in the initial table of contents and the second page of the initial overview.

Bristol-Myers Squibb Co. and a former subsidiary have agreed to pay more than $515 million to settle federal and state investigations into their drug marketing and pricing practices. The civil settlement ... resolves a broad array of allegations against Bristol-Myers Squibb, dating from 1994 through 2005. Among them was a charge that the ... company illegally promoted the sale of Abilify, an anti-psychotic drug, for pediatric use and to treat dementia-related psychoses. Neither use is approved by the U.S. [FDA]. Although physicians are permitted to prescribe drugs for off-label uses, drug companies are prohibited from marketing them for uses that have not been approved by the FDA. U.S. Attorney Michael Sullivan said when pharmaceutical companies market drugs for unapproved uses, there is a potential risk that patients could be harmed, because the drugs have not been tested as rigorously as they are during the FDA approval process. The government also alleged the company paid illegal inducements in the form of consulting fees and trips to luxury resorts to influence doctors and other health care providers to buy and prescribe the company's drugs. The company's former generic drug subsidiary, Apothecon Inc., also was accused of giving illegal enticements to induce retail pharmacy and wholesale customers to buy its products. Bristol-Myers Squibb misreported its best price for the anti-depression drug Serzone, violating a law that requires drug companies to report their lowest price to Medicaid, prosecutors said. The company was selling Serzone to a larger commercial purchaser at a lower price, prosecutors said. Bristol-Myers Squibb and Apothecon also inflated prices for an assortment of oncology and generic drugs knowing that federal health care programs established reimbursement rates based on those prices, Sullivan said.

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The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. The inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed. The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred. “In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said. Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been. The drug agency oversees just the safety of trials by companies seeking approval to sell drugs or devices. Using an entirely different set of rules, the Office for Human Research Protections oversees trials financed by the federal government. Privately financed noncommercial trials have no federal oversight.

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Important Note: Explore our full index to key excerpts of revealing major media news articles on several dozen engaging topics. And don't miss amazing excerpts from 20 of the most revealing news articles ever published.