Pharmaceutical Corruption News Articles

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Drug maker Novartis is taking legal action in Britain to make state-run hospitals use an eye drug that costs about 700 pounds ($1,130) per shot instead of a cheaper one that costs 60 pounds ($97). In a statement, Novartis said it was calling for a judicial review “as a last resort” because it believed patient safety was being potentially compromised. According to the U.K.’s health watchdog, Novartis’ Lucentis is the only drug recommended to treat the eye problem macular degeneration in the country’s state-run National Health Service hospitals. However, several NHS hospitals have been prescribing the much cheaper Avastin, a cancer drug made by Genentech Inc., a subsidiary of Roche, for the same problem even though it has not been officially approved. A study published in the New England Journal of Medicine last year showed Avastin worked just as well as Lucentis for treating the eye disorder. Lucentis and Avastin act on the same biological protein in the body to spur blood vessel growth. In the U.S., eye doctors have often used tiny amounts of Avastin and billed the government for the cost, rather than buying Lucentis. Patient groups called for an independent analysis to determine which drug should be used.

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Dr. Arnold S. Relman [is] 88; Dr. Marcia Angell, 72. But their voices are as strong as ever. Colleagues for decades, late-life romantic partners, the pair has occasionally, wistfully, been called American medicine’s royal couple. In fact, controversy and some considerably less complimentary labels have dogged them as well. From 1977 to 2000, one or both of them filled top editorial slots at The New England Journal of Medicine as it grew into perhaps the most influential medical publication in the world, with a voice echoing to Wall Street, Washington and beyond. Many of the urgent questions in the accelerating turmoil surrounding health care today were first articulated during their tenure. Or, as Dr. Relman summarized one recent afternoon ..., Dr. Angell nodding in agreement by his side: “I told you so.” Their joint crusade ... is against for-profit medicine, especially its ancillary profit centers of commercial insurance and drug manufacture — in Dr. Relman’s words, “the people who are making a zillion bucks out of the commercial exploitation of medicine.” Some have dismissed the pair as medical Don Quixotes, comically deluded figures tilting at benign features of the landscape. Others consider them first responders in what has become a battle for the soul of American medicine.

Note: For a powerful summary of Dr. Marcia Angell's critique of corruption in the medical industry, click here.

Medicines to treat attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the Food and Drug Administration (FDA) that they are unable to find a pharmacy with enough pills to fill their prescriptions. The shortages are a result of a troubled partnership between drug manufacturers and the Drug Enforcement Administration (DEA), with companies trying to maximize their profits and drug-enforcement agents trying to minimize abuse by people. Shortages, particularly of cheaper generics, have become so endemic that some patients say they worry almost constantly about availability. The DEA sets manufacturing quotas that are designed to control supplies and thwart abuse. Every year, the DEA ... allots portions of the expected demand to various companies. How each manufacturer divides its quota among its own ADHD medicines — preparing some as high-priced brands and others as cheaper generics — is left up to the company. Officials at the FDA say the shortages are a result of overly strict quotas set by the DEA, which, for its part, questions whether there really are shortages or whether manufacturers are simply choosing to make more of the expensive pills than the generics, creating supply and demand imbalances.

Note: This curious story reveals an astonishing level of government manipulation of the manufacturing and availability of medications, and corporations appear to go along with it because it keeps profits high. For lots more on government and corportate corruption from reliable sources, click here and here.

It's fraudulent for academics to give their names to medical articles ghostwritten by pharmaceutical industry writers, say two Canadian law professors who call for potential legal sanctions. Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues, said Trudo Lemmens, a law professor at the University of Toronto. The integrity of medical research is also harmed by ghostwritten articles, he said. Ghostwriting is part of marketing that can distort the evidence on a drug, Lemmens said. Industry authors are concealed to insert marketing messages and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analyzing the results and writing up of the findings. Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice. Ghostwritten publications are used in court to support a manufacturer's arguments about a drug's safety and effectiveness, and academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with the publications on their CV, Lemmens said.

Note: For a respected doctor's powerful analysis of fraud in the pharmaceutical industry, click here. For lots more from reliable sources on key health issues, click here.

The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable. Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996. But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government. The cable reports a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It states: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media." The cable ... continues: "A series of damaging articles detailing Aondoakaa's 'alleged' corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa's cronies were pressuring him to drop the suit for fear of further negative articles."

Note: For more on this revealing case, see the New York Times article available here.

Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States. The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data. One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year. "We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development." The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls." High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson, have drawn attention to quality concerns in manufacturing. The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.

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Genetic engineers, move over: the latest scheme for creating children to a parent’s specifications requires no DNA tinkering, but merely giving mom a steroid while she’s pregnant, and presto —- no chance that her daughters will be lesbians or (worse?) ‘uppity.’ Or so one might guess from the storm brewing over the prenatal use of that steroid, called dexamethasone. In February, bioethicist Alice Dreger of Northwestern University and two colleagues blew the whistle on the controversial practice of giving pregnant women dexamethasone to keep the female fetuses they are carrying from developing ambiguous genitalia. Dreger and her colleagues pluck numerous brow-raising statements from the writings of pediatric endocrinologist Maria New of Mount Sinai Medical Center in New York, who has long promoted prenatal dexamethasone. New has indeed argued that prenatal androgens can affect a woman’s sexual orientation, her interest in becoming a mother and housewife, her interest in traditionally masculine careers, and—in childhood—whether she plays with dolls or trucks. A book that Harvard University Press will publish in September, called Brain Storm: Flaws in the Science of Sex Differences, argues that studies claiming to find innate, sex-based brain differences are seriously flawed.

Across the United States, pharmaceutical companies have pleaded guilty to criminal charges or paid penalties in civil cases when the Justice Department finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death. "Marketing departments of many drug companies don't respect any boundaries of professionalism or the law," says Jerry Avorn, a professor at Harvard Medical School. The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional. About 15 percent of all U.S. drug sales are for unapproved uses without adequate evidence the medicines work, according to a study by Randall Stafford, a medical professor at Stanford University. As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms' annual revenue. The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.

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New federally financed drug research reveals a stark disparity: children covered by Medicaid are given powerful antipsychotic medicines at a rate four times higher than children whose parents have private insurance. And the Medicaid children are more likely to receive the drugs for less severe conditions than their middle-class counterparts, the data shows. Those findings, by a team from Rutgers and Columbia, are almost certain to add fuel to a long-running debate. Do too many children from poor families receive powerful psychiatric drugs not because they actually need them – but because it is deemed the most efficient and cost-effective way to control problems that may be handled much differently for middle-class children? The questions go beyond the psychological impact on Medicaid children, serious as that may be. Antipsychotic drugs can also have severe physical side effects, causing drastic weight gain and metabolic changes resulting in lifelong physical problems. Part of the reason is insurance reimbursements, as Medicaid often pays much less for counseling and therapy than private insurers do. Studies have found that children in low-income families may have a higher rate of mental health problems – perhaps two to one – compared with children in better-off families. But that still does not explain the four-to-one disparity in prescribing antipsychotics.

Note: For many important health reports from reliable sources, click here.

The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn. It was the largest health care fraud settlement and the largest criminal fine of any kind ever. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002. The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales. Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave. John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra. “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said Mr. Kopchinski.

Note: For lots more on corporate corruption, click here. For a powerful article on the immense political power of pharmaceutical companies by one of the top MDs in the U.S., click here.

Most of the federal scientists who improperly accepted personal money from drug or biotechnology companies walked away with reprimands or were allowed to retire unscathed. Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll. NIH spokesman John Burklow said his agency wanted eight others reviewed for possible crimes, but those cases were rejected by the investigating office at the U.S. Health and Human Services Department. The two still outstanding...both committed "serious misconduct," so grave that they would be fired if they were civilians, NIH internal ethics reports contend. [A Congressional] subcommittee is expected to question NIH officials about documents showing it approved several taxpayer-paid trips for [Dr. Trey] Sunderland to attend conferences and events in places like Hawaii and Toronto, even after recommending his firing. Of the 44 alleged offenders...the majority received reprimands or warnings for failing to properly obtain approvals for their outside consulting work. NIH ethics reports allege...two scientists had unauthorized, unreported deals with drug companies -- Sunderland earning more than $600,000 over eight years for consulting and speeches and [Dr. Thomas] Walsh more than $100,000 in five years -- and that their consulting improperly overlapped with government duties.

Note: The Los Angeles Times later reported that Dr. Sunderland was the first NIH scientist in 14 years to be found guily of conflict of interest laws. For more vital information on major collusion between government and the pharmaceutical companies: http://www.WantToKnow.info/healthcoverup.

Drug companies are accused today of endangering public health through widescale marketing malpractices, ranging from covertly attempting to persuade consumers that they are ill to bribing doctors and misrepresenting the results of safety and efficacy tests on their products. In a report that charts the scale of illicit practices by drug companies in the UK and across Europe, Consumers International - the world federation of consumer organisations - says people are not being given facts about the medicines they take because the companies hide the marketing tactics on which they spend billions. "Irresponsible marketing practices form a serious, persistent and widespread problem among the entire pharmaceutical industry," says the report, which analyses the conduct of 20 of the biggest companies. Scandals such as the withdrawal of Vioxx ... show that unethical drug promotion is a consumer concern. Merck withdrew the drug in September 2004, but allegedly knew it could increase the chances of heart attacks and strokes from 2000 and has been accused of manipulating study results to play down the risk. More than 6,000 lawsuits have been filed against the company in the United States by people who claim they suffered heart attacks as a result of the drug. There is no room for complacency when drug companies spend twice as much on marketing as on research...but do not publish information on their drug promotion practices.

Vaccine industry officials helped shape legislation behind the scenes that Senate Majority Leader Bill Frist secretly amended into a bill to shield them from lawsuits, according to e-mails obtained by a public advocacy group. E-mails and documents written by a trade group for the vaccine-makers show the organization met privately with Frist's staff and the White House about measures that would give the industry protection from lawsuits filed by people hurt by the vaccines. Frist, along with House Speaker Dennis Hastert, R-Ill., ordered the vaccine liability language inserted in a defense spending bill in December without debate and in violation of usual Senate practice. In a written statement, Frist spokeswoman Amy Call stated that the senator had promised publicly to include the vaccine liability protection in the defense spending bill. She did not address the issue of the influence of industry lobbyists.

Note: For one-paragraph summaries of media articles showing why the vaccine makers want this protection, click here.

Doctors accused of making up data in medical studies. Allegations of misconduct by U.S. researchers reached record highs last year as the Department of Health and Human Services received 274 complaints - 50 percent higher than 2003 and the most since 1989 when the federal government established a program to deal with scientific misconduct. Chris Pascal, director of the federal Office of Research Integrity, said its 28 staffers and $7 million annual budget haven't kept pace with the allegations. The result: Only 23 cases were closed last year. Of those, eight individuals were found guilty of research misconduct. In the past 15 years, the office has confirmed about 185 cases of scientific misconduct. Research suggests this is but a small fraction of all the incidents of fabrication, falsification and plagiarism. In a survey published June 9 in the journal Nature, about 1.5 percent of 3,247 researchers who responded admitted to falsification or plagiarism. (One in three admitted to some type of professional misbehavior.)

Despite calls for more transparency after revelations about the side effects of ibuprofen, the FDA has withheld 28 pages of information on a new wave of painkillers. Vital data on prescription medicines found in millions of British homes has been suppressed by the powerful US drug regulators, even though the information could potentially save lives. An investigation by The Independent on Sunday shows that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks. Dr Peter Juni, one of the team of Swiss investigators who helped to expose the risk of the new-generation drugs, claims his efforts were obstructed by the FDA. "Too often the FDA saw and continues to see the pharmaceutical industry as its customers, a vital source of funding for its activities, and not as a sector of society in need of strong regulation."

When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden. Eli Lilly and some other companies have posted hundreds of trial results on the Web and pledged to disclose all results for all drugs they sell. But other drug makers, including Merck and Pfizer, release less information and are reluctant to add more, citing competitive pressures. As a result, doctors and patients lack critical information about important drugs ... and the companies can hide negative trial results by refusing to publish studies, or by cherry-picking and highlighting the most favorable data. GlaxoSmithKline agreed to pay $2.5 million to settle a suit ... alleging that Glaxo had hidden results from trials showing that its antidepressant Paxil might increase suicidal thoughts in children and teenagers. Federal laws require the disclosure of all trials and trial results to the F.D.A. But companies are not required to disclose trial results to scientists or the public. Under pressure from the editors of medical journals, the major drug companies in January agreed to expand the number of trials registered on clinicaltrials.gov. Three companies have filed only vague descriptions of many studies, often failing even to name the drugs under investigation. For example, Merck describes one trial as a "one-year study of an investigational drug in obese patients."

It was the kind of study that made doctors around the world sit up and take notice: Two popular high-blood-pressure drugs were found to be much better in combination than either alone. Unfortunately, it wasn't true. Six and a half years later, the prestigious medical journal the Lancet retracted the paper, citing "serious concerns" about the findings. The damage was done. Doctors by then had given the drug combination to well over 100,000 patients. Instead of protecting them from kidney problems, as the study said the drug combo could do, it left them more vulnerable to potentially life-threatening side effects, later studies showed. Today, "tens of thousands" of patients are still on the dual therapy, according to research firm SDI. When a study is retracted, "it can be hard to make its effects go away," says Sheldon Tobe, a kidney-disease specialist at the University of Toronto. And that's more important today than ever because retractions of scientific studies are surging. Since 2001, while the number of papers published in research journals has risen 44%, the number retracted has leapt more than 15-fold, data compiled for The Wall Street Journal by Thomson Reuters reveal. Just 22 retraction notices appeared in 2001, but 139 in 2006 and 339 last year

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The U.S. Supreme Court let stand a ruling that drug companies can pay rivals to delay production of generic drugs without violating federal antitrust laws. The justices refused to review a federal appeals court ruling that upheld the dismissal of a legal challenge to a deal between Bayer AG and Teva Pharmaceutical Industries Ltd's Barr Laboratories. Bayer paid Barr to prevent it from bringing to market a version of the antibiotic drug Cipro. The deal, involving Bayer's 1997 settlement of patent litigation with Barr, was challenged by a number of pharmacies, which appealed to the Supreme Court. More than 30 states and various consumer groups supported the appeal. The U.S. Federal Trade Commission has opposed such deals, saying they violate antitrust law and cost consumers an estimated $3.5 billion a year in higher prescription drug prices. It has supported legislation pending in Congress to prohibit such settlements, which it says have increased in recent years. The New York-based appeals court, in its ruling last year, cited its similar 2005 decision involving the drug Tamoxifen, used to treat breast cancer, infertility and other conditions. The Supreme Court declined to review that case. In the Cipro case, the Supreme Court rejected the appeal by the pharmacies without comment.

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A $112 million settlement involving alleged drug kickbacks that the Justice Dept. announced with the nation's largest nursing home pharmacy and a generic drug manufacturer on Nov. 3 is part of a wide-ranging investigation of suspected Medicaid fraud by the pharmaceutical industry. Critics say the continuing probe, which involves ... major drugmakers, highlights what they describe as an industry practice of paying money to outfits that provide drugs to consumers, in return for preferential treatment. Because those alleged payoffs have the effect of compromising patient care and driving up costs for government and private health insurers, cases like the settlement unsealed with Omnicare (OCR) in Covington, Ky., and IVAX Pharmaceuticals in Weston, Fla., could bolster opposition to the controversial deal the Obama Administration reached with the pharmaceutical industry to win its support for health-reform legislation. Many Democrats say the Administration should have asked for much bigger cost savings from drugmakers. Patrick Burns, a spokesman for Taxpayers Against Fraud, a nonprofit Washington group that promotes whistleblower suits, says the Justice Dept. is backed up with pharmaceutical fraud cases. Since drugmakers offer so many similar products, he contends, they rely on kickbacks to give their products a market edge. "In the pharmaceutical industry, the business isn't selling the best drug, it's the best scheme of kickbacks to the prescriber."

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Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient’s kidneys and raise their risk of death? Chances are you didn’t, and neither did your doctor. Much of what the Food and Drug Administration knows about a drug’s safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible. In ... the New England Journal of Medicine, researchers ... argue that drug labels don’t reflect the nuanced decisions the FDA makes when deciding to approve a drug. The editorial from Drs. Lisa Schwartz and Steven Woloshin recommends easy-to-read fact boxes to help patients weigh the benefits and risks of medications. If drug labels sometimes exaggerate benefits and play down drug risks, the authors say there’s a very good reason: they are written by drugmakers. While FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists. The labeling is based on results from company studies, which generally compare results for patients taking the drug versus those taking placebo. If FDA decides the drug’s ability to treat or prevent a disease outweighs its side effects, the agency is obligated to approve it. But Schwartz and Woloshin point out that benefits may be slim and potential harms may not be fully understood. “The take home point is that just because a drug is approved doesn’t mean it works very well,” said Schwartz, in an interview with the Associated Press. “You really need to know more to see whether it’s worth the cost.” Schwartz and Woloshin say FDA labeling frequently fails to provide a full picture of a drug’s effects.

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

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