Bad Wire in Heart Device Led to 22 Deaths, Study Says
By KATIE THOMAS
Published: March 27, 2012

A defect in wires that connect hearts to defibrillators caused at least 22 deaths, possibly as a result of a short circuit that is difficult to detect during routine monitoring, according to a study in the journal Heart Rhythm.

The manufacturer of the wires, St. Jude Medical, estimated that about 79,000 patients in the United States and about 49,000 patients elsewhere have had the wires implanted. Removing the wires is considered dangerous.

The study looked at deaths reported to the Food and Drug Administration that were associated with two models of the wires, also known as leads, under the brand names Riata and Riata ST. St. Jude removed the leads from the market in 2010, and the agency issued a formal recall in 2011 because of a problem involving wires that were found to be protruding from the protective casing on the leads.

St. Jude introduced the Riata in 2002 and the Riata ST in 2005.
The most recent study found that the problem with the protruding wires did not contribute to any deaths, while the electrical malfunction was more serious, said Dr. Robert Hauser, the author of the study and an advocate for improved safety of medical devices.

“When I went in, I thought I would find more deaths related to externalized cables,” he said, referring to the problem of wires poking through the casing. “But as it turned out, the externalized cables really didn’t factor in.”
Defibrillators, small battery-powered canisters implanted into muscle under the collarbone, apply electrical shocks to the heart when its beating becomes dangerously rapid or chaotic. The shocks can restore normal heart rhythms before the heart stops and prevent sudden death. The leads are used to sense when the heart is experiencing a rhythm that requires a shock and then helps deliver the shock.

Dr. Hauser said he found that the silicone insulation on the Riata cables was breaking down and resulting in an electrical short. Such shorts are dangerous, he said, because they can prevent the device from delivering the shock that restores a normal heartbeat. They can also occur without any warning that the device is defective.
In his study, released on Monday, Dr. Hauser found that eight patients had died during procedures to remove the wires.

He said that the number of deaths was small compared with the number of patients who had these models of wires. However, “because it may be catastrophic, we need to be paying more attention to what are the electrical signs that might help us identify patients who are at risk,” he said.

Dr. Mark Carlson, chief medical officer at St. Jude, questioned some of Dr. Hauser’s conclusions. He said the reports the F.D.A. collects are often incomplete. He said the company’s data showed the number of deaths to be 20, not 22, and he said seven of the deaths resulted from a far more common type of failure caused by the wire rubbing against the defibrillator. He said St. Jude had not called more attention to the electrical malfunctions — in contrast to its warnings about the protruding wires — because the electrical failures were far more common.

Dr. Lawrence M. Epstein, chief of the arrhythmia service at Brigham and Women’s Hospital in Boston and an associate professor of Medicine at Harvard Medical School, said two of his patients had suffered electrical failures of Riata leads but survived because they were in the hospital at the time. Dr. Epstein has worked as a consultant for St. Jude and other device makers. Since removing the wires is dangerous, “it creates a real clinical dilemma for patients and the doctors taking care of them,” he said.

This article has been revised to reflect the following correction:

Correction: March 27, 2012
An earlier version of this article misstated the organization that issued the recall in 2011 on the leads made by St. Jude Medical. The Food and Drug Administration, not St. Jude, issued the recall. The article also misstated the number of deaths, according to the company’s data, caused by the wire rubbing against the defibrillator. It was seven, not 13.

Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.

That result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.

“Explain the difference between the generic and the real one — it’s just a different company making the same thing,” Ms. Schork said.

Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.

Now, what once seemed like a trivial detail — whether to take a generic or brand-name drug — has become the deciding factor in whether a patient can seek legal recourse from a drug company. The cases range from that of Ms. Schork, who wasn’t told which type of drug she had been given when she visited the hospital, to people like Camille Baruch, who developed a gastrointestinal disease after taking a generic form of the drug Accutane, as required by her health care plan.

“Your pharmacists aren’t telling you, hey, when we fill this with your generic, you are giving up all of your legal remedies,” said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in last year’s Supreme Court case, Pliva v. Mensing. “You have a disparate impact between one class of people and another.”

The Supreme Court ruling affects potentially millions of people: nearly 80 percent of prescriptions in the United States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.

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Heart Device Parts Recalled
By BLOOMBERG NEWS
Published: December 15, 2011

St. Jude Medical said on Thursday that its Riata defibrillator leads, which the company stopped selling last year, had been recalled by the Food and Drug Administration because of their potential to injure or kill patients.

The devices remain implanted in an estimated 79,000 patients, St. Jude said. The company voluntarily sent a letter to doctors on Nov. 28 informing them that the wires, which are used to connect the devices to the heart, had a higher failure rate than was previously known.

The F.D.A. deemed the letter a Class 1 recall, its most serious designation, because of its potential risks, the company said. The wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others, the company said.

“At this time, no blanket statement can be made about clinical recommendations,” Anne Curtis, chairwoman of medicine at the University at Buffalo in New York and a member of St. Jude’s medical advisory board, said in the statement. “Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads.”

Merck to Pay $950 Million Over Vioxx
By DUFF WILSON
Published: November 22, 2011

Merck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx, the company and the Justice Department said Tuesday. The negotiated settlement, which includes resolution of civil cases, was the latest of a series of fraud cases brought by federal and state prosecutors against major pharmaceutical companies.

By the time Vioxx, which was approved by the Food and Drug Administration in 1999, was pulled off the market in 2004 because evidence showed that it posed a substantial heart risk, about 25 million Americans had taken the drug.
In a statement on Tuesday, Merck said that it had previously disclosed the seven-year investigation by the United States attorney in Massachusetts and had charged $950 million against its earnings in October 2010.

Merck agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce, the Justice Department said in a news release. The charge arose from Merck’s promotion of Vioxx to treat rheumatoid arthritis before the Food and Drug Administration approved it for that purpose in 2002. Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. Those payments will settle civil claims that its illegal marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed.

Physicians are free to prescribe drugs for any purpose they see fit, but pharmaceutical companies are prohibited from marketing them for any uses except those that the Food and Drug Administration has determined are safe and beneficial.

“When a pharmaceutical company ignores F.D.A. rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients,” Tony West, assistant attorney general of the Justice Department’s civil division, said in a statement.
> full story

In an unusual move, the Food and Drug Administration has ordered all producers of a popular category of artificial hip to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.

Under the order, producers of "metal-on-metal" hips will have to conduct studies of patients who received the device to determine, among other things, whether the implants are shedding high levels of metallic debris. Some patients have encountered that problem, including soft tissue damage that has disabled them.

In a telephone interview on Tuesday, Dr. William H. Maisel, the deputy director for science at the F.D.A.'s Center for Devices and Radiological Health, said the order marks the broadest use of the agency's authority to conduct studies of devices after approval for sale. He also said that the F.D.A. wanted information about the entire category of implants, not any single manufacturer's device.

"Our concern is the product, not about a manufacturer," said Dr. Maisel.

The F.D.A. told about 20 manufacturers in a letter issued Friday that it was invoking a rule requiring postmarket studies in cases where an implant's failure could have serious consequences.

The agency's action could also prompt increased scrutiny of regulatory policies that allow implants like metal-on-metal hips to be approved for sale with little, if any, clinical testing in patients. In addition, the F.D.A.'s oversight of hip implants has lagged that in other countries where registries follow the failure rate of orthopedic implants in patients.
> full story

Tipping the Odds for a Maker of Heart Implants
Isaac Brekken for The New York Times
By BARRY MEIER
Published: April 2, 2011

Las Vegas is a city of few sure bets. But there are overwhelming odds on one thing — the brand of heart device that patients at a major hospital get.

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Pfizer Told to Pay $142.1 Million Over Marketing of Epilepsy Drug
By BLOOMBERG NEWS
Published: January 28, 2011

Pfizer, the drug maker, has been ordered to pay a total of $142.1 million in damages for violating federal racketeering laws in the marketing of its epilepsy drug Neurontin.

Judge Patti B. Saris of United States District Court in Boston upheld a jury's finding that the Kaiser Foundation Health Plan and Kaiser Foundation Hospitals deserved the award over their claims that Pfizer illegally promoted Neurontin for unapproved uses.

In her ruling on Thursday, Judge Saris tripled the jury's award of $47.3 million under a provision of the Racketeer Influenced and Corrupt Organizations Act of 1970.

Kaiser officials claimed they were duped into believing that migraines and bipolar disorder could be treated effectively with Neurontin, approved in 1993 by the Food and Drug Administration for epilepsy.

Chris Loder, a Pfizer spokesman, said the company intended to appeal.

Kaiser, based in Oakland, Calif., claimed it was forced to pay $90 million more than it should have for the drug.
Pfizer currently faces more than 300 suits accusing it of illegally promoting Neurontin or hiding its health risks. Lawyers for former users of Neurontin contend the drug maker knew the medicine posed a suicide risk and failed to disclose it to patients and doctors. The Warner-Lambert Company developed and marketed Neurontin for several years before Pfizer acquired the drug maker in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the Justice Department.

J.&J. Unit Is Told to Pay $482 Million to New Jersey Doctor in Patent Case
By BLOOMBERG NEWS
Published: January 28, 2011

A jury told Johnson & Johnson on Friday to pay $482 million to a New Jersey radiologist for infringing on a patent on devices to prop open heart arteries.

The jury, in Federal District Court in Texas, ruled that Johnson & Johnson's Cordis unit had infringed on a patent for a device used to treat damaged heart tissue and awarded the damages to the patent holder, Dr. Bruce Saffran, of Princeton, N.J.

"We've been fighting this battle since 2003," said Dr. Saffran's lawyer, Paul Taskier of Dickstein Shapiro in Washington. "Today we proved they were infringing, and the jury understood."

The Cordis unit said it would challenge the verdict.

"This is contrary to both the law and the facts set forward in the case," said Sandy Pound, a spokeswoman for Cordis. "We will ask the judge to overturn this verdict and if unsuccessful, we plan to appeal the verdict."

The verdict is the second to uphold Dr. Saffran's patent.

He won a similar case in 2008 against the Boston Scientific Corporation. In that case, Dr. Saffran was awarded $501 million but settled for $50 million while the case was being appealed.

He also has an infringement case against Abbott Laboratories, in which a trial is scheduled for August 2012.

Earlier Hormone Therapy Elevates Breast Cancer Risk, Study Says
By DENISE GRADY
Published: January 28, 2011

Growing evidence about the risks of breast cancer and other serious illnesses posed by hormone therapy for menopause has led many women to give up the drugs, and many doctors to stop recommending them.

But there has been a lingering belief that for younger women in the early stages of menopause, hormone risks may be negligible, at least for a while. So those who are really suffering from hot flashes, insomnia and other symptoms are often told that it is probably all right to take the drugs, as long as they use the lowest possible dose for the shortest possible time. Some researchers are even testing an idea, called the timing hypothesis, that starting hormone treatment early in menopause may help protect women from heart disease.

Now, information from a huge study in Britain suggests that the women thought to be at the lowest risk from hormones may actually be at the highest risk, at least when it comes to breast cancer. The study found that women with the greatest risk of breast cancer from hormones were those who took them earliest — before or soon after menopause began. > full story

Judge Accepts Guilty Plea by Guidant
By BLOOMBERG NEWS
Published: January 13, 2011

A judge accepted a guilty plea by Guidant, on charges that it hid defects in heart defibrillators, and placed the company on three years' probation to deter similar conduct. Judge Donovan W. Frank, of the United States District Court in St. Paul, agreed on Wednesday to honor Guidant's plea agreement after rejecting it in April. Boston Scientific agreed in November that Guidant, one of its units, would plead guilty to two misdemeanors and pay $296 million to settle a Justice Department inquiry. Judge Frank added the probationary term at the hearing.

"There were decisions made deliberately to advantage the company by withholding information and misrepresenting information," Robert Lewis, an assistant United States attorney, said in court. Prosecutors said in court papers that officials at Guidant learned as early as 2002 that some of the implantable defibrillators had a tendency to short-circuit and cause deaths. The company did not disclose the defects for more than three years, prosecutors said. Paul Donovan, a Boston Scientific spokesman, did not return a call or respond to an e-mail seeking comment on the judge's decision.

Boston Scientific halted all sales of heart-rhythm devices in March because of an erroneous filing with regulators. The Food and Drug Administration cleared the company to begin selling defibrillators again about a month later. The devices are implanted in patients' bodies to shock hearts back into normal rhythm.


Doctor Faces Suits Over Cardiac Stents
By GARDINER HARRIS
Published: December 5, 2010

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, “which is the biggest day I remember hearing about,” an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore.

The Senate Finance Committee, which oversees Medicare, started investigating Dr. Midei in February after a series of articles in The Baltimore Sun said that Dr. Midei at St. Joseph Medical Center, in Towson, Md., had inserted stents in patients who did not need them, reaping high reimbursements from Medicare and private insurance.

The senators solicited 10,000 documents from Abbott and St. Joseph. Their report, provided in advance to The New York Times, concludes that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures. full story

Pfizer Plans $75 Million Fund to Address Shareholder Suits
By DUFF WILSON
Published: December 3, 2010
Pfizer has agreed to set up a $75 million fund and to create a new compliance committee to settle shareholders’ lawsuits accusing the board and top officials of failing to stop illegal marketing of its drugs, according to a settlement agreement filed in United States District Court on Friday.

The company denied any wrongdoing as part of the preliminary settlement, which is subject to judicial review. A Pfizer spokesman said the fund and committee would advance the regulatory and ethics work it had already started in recent years amid a series of government investigations.

Mark Lebovitch, lead counsel for the institutional investors who brought the lawsuits, said it would be one of the largest derivative settlements ever and a good outcome for shareholders.

The suits were filed after Pfizer, the world’s largest pharmaceutical company, settled federal marketing investigations in September 2009. The company paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes. The total included the largest criminal fine in United States history, $1.3 billion, on a charge of illegal marketing of the painkiller Bextra, which was withdrawn from the market in 2005.

Last year’s case was Pfizer’s fourth settlement since 2002 over illegal marketing. full story

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Drug Maker Cited on Quality Issues
By NATASHA SINGER
Published: November 26, 2010

Months after McNeil Consumer Healthcare, a unit of Johnson & Johnson, recalled millions of bottles of Tylenol and other over-the-counter drugs, the division is still plagued with manufacturing flaws, according to the Food and Drug Administration.

Agency officials who filed an inspection report, posted on the agency’s Web site this month, about a McNeil plant in Puerto Rico cited a variety of problems: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.

Last January, the agency sent a warning letter to Peter Luther, the president of McNeil, about significant manufacturing violations at the same plant. The new inspection report indicates that some problems have not been corrected, said Karen Riley, a spokeswoman for the F.D.A.

“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law,” Ms. Riley said Friday. The agency, she added, was not aware of any harm to consumers associated with the latest problems at that plant. Bonnie Jacobs, a spokeswoman for McNeil, said on Friday that the company had responded in detail to the F.D.A.’s concerns. click here for the full story.

Ex-Glaxo Executive Is Charged in Drug Fraud
By DUFF WILSON
Published: November 9, 2010

In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss.

The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments.

“This is absolutely precedent-setting — this is really going to set people’s hair on fire,” said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. “This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.”

The indictment accuses the Glaxo official, Lauren C. Stevens of Durham, N.C., of lying to the Food and Drug Administration in 2003, by writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens “made false statements and withheld documents she recognized as incriminating,” including slides the F.D.A. had sought during its investigation, the indictment stated. click here for the full story.


Breast Cancer Seen as Riskier With Hormone
By DENISE GRADY
Published: October 19, 2010

Hormone treatment after menopause, already known to increase the risk of breast cancer, also makes it more likely that the cancer will be advanced and deadly, a study finds. Women who took hormones and developed breast cancer were more likely to have cancerous lymph nodes, a sign of more advanced disease, and were more likely to die from the disease than were breast cancer patients who had never taken hormones.

The increased risks were relatively small and are not fully understood. But previous research has found that hormone treatment can cause delays in diagnosis by increasing breast density, making tumors harder to see on mammograms. Delayed diagnosis may increase the risk of death.

It is also possible that hormones may feed the growth of some breast cancers or the blood vessels that tumors need to grow and spread.

The treatment studied was the most commonly prescribed hormone replacement pill, Prempro, which contains estrogens from horse urine and a synthetic relative of the hormone progesterone.

Many doctors assume that women can safely take hormones for four or five years for menopause symptoms like hot flashes and night sweats, said Dr. Rowan T. Chlebowski, the first author of an article published this week in The Journal of the American Medical Association and an oncologist who treats breast cancer patients at the Harbor-U.C.L.A. Medical Center in Torrance, Calif.

“I don’t think you can say that now,” he said. “I know some people have to take it because they can’t function, but the message now is that you really should try to stop after a year or two.” Dr. Chlebowski said it was not known whether there is any length of time for which these hormones can be taken without increasing breast cancer risk. click here for the full story.

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Glaxo Memo on Avandia Is Questioned
By GARDINER HARRIS
Published: August 19, 2010

Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.

But a federal official and some members of the panel now say the company’s letter is misleading and could endanger patients. The dispute is occurring just weeks before the Food and Drug Administration is expected to announce whether Avandia’s label must include new warnings, whether sales of the drug will be restricted or whether Avandia must be withdrawn from the market.

Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.

Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue. click here for the full story.

After Avandia: Does the FDA Have a Drug Problem?
By Massimo Calabresi with Alice Park Thursday, Aug. 12, 2010

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.

But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk. click here for the full story.

Concerns Over ‘Metal on Metal’ Hip Implants
By BARRY MEIER
Published: March 3, 2010
Some of the nation’s leading orthopedic surgeons have reduced or stopped use of a popular category of artificial hips amid concerns that the devices are causing severe tissue and bone damage in some patients, often requiring replacement surgery within a year or two. In recent years, such devices, known as “metal on metal” implants, have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. They are used in conventional hip replacements and in a popular alternative procedure known as resurfacing. The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, became widely used in the belief that they would be more durable than previous types of implants. click here for the full story.

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Nissen met with drug maker execs, recorded it
By The New York Times
February 22, 2010, 10:59PM
GARDINER HARRIS, New York Times
Three years ago, Cleveland Clinic cardiologist Steven Nissen conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a congressional inquiry, stringent safety warnings, a sharp drop in the drug's sales and a plunge in the share price of GlaxoSmithKline, Avandia's maker. The battle between Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Nissen's study was published in The New England Journal of Medicine, he and four company executives met face to face in a meeting whose details have not been disclosed until now. Fearing he would face pressure and criticism from executives, Nissen secretly recorded the meeting -- which is legal in Ohio as long as one party to the conversation is aware of the taping. Nissen shared the contents of the recording with the New York Times. click here for the full story.

Avandia users have other, safer options, local doctors say
By Brie Zeltner, The Plain Dealer
February 23, 2010, 6:00AM
Avandia users should stop taking the diabetes drug, say many local doctors who believe there are other, safer options for their patients. A government report released Saturday revealed drugmaker GlaxoSmithKline's internal efforts to quell studies that showed risks associated with its diabetes medication. While the report offered no new data on Avandia's safety, it confirmed the concerns brought to light in 2007 by Cleveland Clinic cardiologist Steven Nissen, who warned of the increased potential for heart attack in people taking the drug in a New England Journal of Medicine study. The report, written by Senators Chuck Grassley and Max Baucus of the Finance Committee has renewed concern over the safety of the drug. click here for the full story.

Another Loss for Pfizer in Drug Suits
By DUFF WILSON
Published: November 23, 2009
Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used hormonal drugs, state court officials in Philadelphia said Monday.
A jury reached a $28 million judgment in one of the women’s cases on Monday, while a judge unsealed a month-old $75 million judgment in the other case. The earlier finding of punitive damages had been sealed to avoid prejudicing the second jury in the same courthouse. Pfizer said it would appeal the Philadelphia decisions, as it has in two similar cases it has lost elsewhere in the country. click here for the full story.

Former Drug Executive Convicted of Wire Fraud
By ANDREW POLLACK
Published: September 29, 2009
In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.
But the executive, W. Scott Harkonen, the former chief executive of InterMune, was acquitted by the federal jury in San Francisco of a related charge of off-label marketing itself, known as “misbranding,” the Justice Department said. click here for the full story.

High Stakes for Merck in Litigation on Fosamax
By NATASHA SINGER
Published: September 2, 2009
Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck that has been taken by millions of women to offset the bone loss associated with menopause.
It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw. Dental surgery is one of the triggers for the condition that can break down jawbone tissue, causing the gums to fall away and expose bone that looks moth-eaten, oral surgeons said. click here for the full story.

Document Details Plan to Promote Costly Drug
By GARDINER HARRIS
Published: September 1, 2009

The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost.

No drug better demonstrates the industry’s salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. And a document quietly made public recently by the Senate’s Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller. The document, “Lexapro Fiscal 2004 Marketing Plan,” is an outline of the many steps Forest used to make Lexapro a success. Because of concerns from Forest, the Senate committee released only 88 pages of the document, which may have originally run longer than 270 pages. “Confidential” is stamped on every page. click here for the full story.

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Roche Accepts No Responsibility in Withdrawal of Accutane

Thursday, July 23rd, 2009
The manufacturer of Accutane, Roche Holding AG, has withdrawn its acne drug Accutane from the U.S. market after several trials during which juries awarded damages of more than $33 million dollars in compensation to injured consumers who alleged that their use caused them to suffer bowel disease including ulcerative colitis, a form of inflammatory bowel disease (IBD).

Accutane had been manufactuered, supplied, marketed and sold to approximately 13 million consumers since it was introduced to the market in 1982. The medication was Roche’s second-biggest selling drug but its sales fell precipitously after it lost its long standing sole patent to generic manufacturers.

Roche communicated its decision to withdraw Accutane from the U.S. market to the Food and Drug Administration. Its spokes person issued a statement in which it failed to accept accountability, saying only:

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously.”

Accutane Recall – Accutane Taken Off Market – Accutane Side Effects

In June 2009, Roche announced a recall of the medication after a court decision awarded more than $33 million in damages to victims of Accutane injury. Prior to the June 2009 court order, Roche was required to pay damages in several other cases, including $13 million in November 2008, $10.5 million in April 2007, $2.62 million in May 2007 and $7 million in October 2007.

Facing 5,000 more product liability claims, Roche cited the high cost of lawsuits as one of its main factors in pulling the product. In addition to discontinuing the product in the United States, Roche has also pulled Accutane from 11 other international markets.

Patients are still able to obtain Accutane from pharmacies, but not directly from Roche.

Accutane Side Effects – Accutane Suicide and Bowel Diseases
Accutane has been linked with a wide range of life-threatening side effects, including psychiatric problems. More than 142 suicide cases involving Accutane have been reported to the Food and Drug Administration (FDA). In response, the FDA issued a warning to healthcare professionals to monitor their patients for signs of depression while they are on the medication.

Additionally, several patients claim Accutane caused side effects including musculoskeletal disorders, multiple sclerosis, diabetes, hepatitis, hepatotoxicity, liver damage, kidney damage, lupus, birth defects and fetal death.

Recently, the acne medication has been linked to gastrointestinal disorders, including:

* Crohn’s disease
* Inflammatory bowel disease (IBD)
* Irritable bowel syndrome (IBS)
* Ulcerative colitis

More than 13 million people in the United States use Accutane, which was once Roche’s second-best selling drug.

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate
By GARDINER HARRIS
Published: July 12, 2010

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart. But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law. “This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.

The heart risks from Avandia first became public in May 2007, with a study from a cardiologist at the Cleveland Clinic who used data the company was forced by a lawsuit to post on its own Web site. In the ensuing months, GlaxoSmithKline officials conceded that they had known of the drug’s potential heart attack risks since at least 2005.    >full story

Caustic Government Report Deals Blow to Diabetes Drug
By GARDINER HARRIS
Published: July 9, 2010
WASHINGTON — A federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events. Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote. The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the F.D.A. that the manufacturer,

GlaxoSmithKline, withdraw Avandia from the market or restrict its sale. full story

JB Reed/Bloomberg News

Heart Risks Seen in Diabetes Medicine
By GARDINER HARRIS
Published: June 28, 2010

WASHINGTON — Two studies published in influential medical journals and using very different methods found that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, substantially increased patients’ heart risks.
The studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market.full story

Cleveland Clinic cardiologist Steven Nissen again thrust in spotlight for watchdog role
By Sarah Jane Tribble, The Plain Dealer
February 22, 2010, 5:45AM

Cleveland Clinic cardiologist Dr. Steven Nissen is once again positioned as a change-maker after revelations in a government report released this weekend renewed concerns that the diabetes drug Avandia causes heart attacks. The watchdog doctor, whose day job is chair of cardiovascular medicine at the international hospital, first raised warnings about the controversial drug in a 2007 New England Journal of Medicine article. When Nissen's study, reviewed by peers, found that Avandia was associated with a 43-percent increased risk of heart attacks, the drug's maker, GlaxoSmithKline, defended the product.

Now, it turns out, the drug maker privately confirmed Nissen's findings. Some leading academics say the 342-page government report released Saturday further illustrates the importance of outside scrutiny of the pharmaceutical companies by people like Nissen and the need to make the U.S. Food and Drug Administration more accountable to the public. "The industry is not going to fix itself because it's in business to sell drugs," said Marcia Angell, senior lecturer in social medicine at Harvard Medical School in the division of medical ethics in a phone interview Sunday.   full story

Research Ties Diabetes Drug to Heart Woes
By GARDINER HARRIS
Published: February 19, 2010

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. Avandia was once one of the world's biggest-selling drugs.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009. “Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.    full story

Doctor Is Pressed Again on Ties to Device Makers
By BARRY MEIER
Published: September 21, 2009
Two leading senators have charged that a well-known heart doctor affiliated with Columbia University may have failed to tell the university about millions of dollars in payments and other income he received from medical device makers.
In a letter sent Friday, the lawmakers, Herb Kohl, Democrat of Wisconsin, and Charles E. Grassley, Republican of Iowa, said that their review of financial data subpoenaed last year from device makers and physicians indicated that the cardiologist, Dr. Martin B. Leon, might have failed to tell Columbia about significant amounts in consulting fees, speaking fees and other payments.“Dr. Leon appears to have failed to report millions of dollars that he has received in outside income,” their letter stated.    full story

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Levaquin Side Effects - Tendon Ruptures Prompt Black Box Warning
A leading antibacterial drug has come under increased scrutiny by the Food and Drug Administration following reports of serious injuries to tendons and ligaments linked with its use. Levaquin manufactured by Ortho-McNeil/Janssen is one of the antibiotics known as flouroquinolones, a class of commonly used antibacterial drugs.    full story

Senator Moves to Block Medical Ghostwriting
By NATASHA SINGER
Published: August 18, 2009
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products. Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account. Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.    full story

Medical Papers by Ghostwriters Pushed Therapy
By Natasha Singer
Published: August 4, 2009, The New York Times
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.    full story

Fleet Lawsuit: Kidney Failure (Acute Phosphate Nephropathy)
Important update: C.B. Fleet Company has announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.

May 5, 2006 —The Food and Drug Administration (FDA) is warning health care professionals and patients that a rare but serious form of kidney failure (acute phosphate nephropathy) has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. OSP products are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet Phospho-soda and Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol).

Acute phosphate nephropathy, a type of acute renal failure, is a rare, but serious adverse event associated with oral sodium phosphate bowel cleansing. When acute phosphate nephropathy occurs, renal impairment is often permanent and may require chronic dialysis. Read more about Fleet kidney failure. Individuals at increased risk include: those of advanced age, those with decreased intravascular volume or kidney disease, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).    full story

Weight Loss Supplement Hydroxycut Pulled From Market!!
LIVER FAILURE, KIDNEY FAILURE, and DEATH

We are currently investigating claims against Iovate, the manufacturer of Hydroxycut, for injuries to consumers arising from their use of Hydroxycut. Specifically, the FDA has recalled Hydroxycut due to incidents of liver damage and death associated with the product.  
 
Liver Failure: Liver injury can be documented by Liver Function tests, CT scans, and Liver Biopsy.  Liver Damages is often associated with Jaundice (yellowish skin), abdominal swelling, and fatigue. Sometime Liver Failure can result in the need for a Liver Transplant.  If you've had any of these tests which show damage, and have been diagnosed with Liver Damage you may have a claim.
 
Kidney Failure: Renal failure associated with Hydroxycut can be documented through blood tests revealing elevated Creatinine clearance levels.  If you have been diagniosed with kidney failure, or put on dialysis after taking Hydroxycut, you may have a valuable claim.
 
Rhabdomyolysis: Rhadbdomyloysis is another injury which has been associated with Hydroxcut, a disease marked by extreme muscle pain, especially in the legs, and can be associated with kidney failure, as well.
 
If you or a loved one ingested Hydroxycut and, while taking Hydroxycut suffered Liver Failure, Liver Transplant, Kidney Failure, jaundice (yellowish skin); abdominal pain and swelling; fatigue; or nausea for which you or your loved one sought medical treatment, you may have a valuable claim.  If so, we would like to discuss this matter with you immediately. Please contact us as soon as you are able.  We look forward to hearing from you soon.
 
Please call us toll free 1-880-556-4769 to discuss your case.


Doctor’s Pain Studies Were Fabricated, Hospital Says
By GARDINER HARRIS
Published: March 10, 2009

In what may be among the longest-running and widest-ranging cases of academic fraud, one of the most prolific researchers in anesthesiology fabricated much of the data underlying his research, said a spokeswoman for the hospital where he works. The researcher, Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., who practiced at Baystate Medical Center, fabricated data in some or all of the 21 journal articles dating from at least 1996, said Jane Albert, a spokeswoman for Baystate Health.

The reliability of dozens more articles he wrote is uncertain, and the common practice — supported by his studies — of giving patients aspirinlike drugs and neuropathic pain medicines after surgery instead of narcotics is now being questioned. Paul Cirel, a lawyer for Dr. Reuben, said that he could not discuss the case because Baystate had investigated it as part of a confidential peer-review process. Baystate officials “were aware of extenuating circumstances,” Mr. Cirel said. full story

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>Guilty Pleas in Inquiry Into Stryker’s Marketing
By BARRY MEIER
Published: February 19, 2009

A Justice Department inquiry into Stryker’s marketing of human bone growth products has resulted in guilty pleas by former company sales representatives. One former sales official pleaded guilty two weeks ago, and another one did in November, court documents show.

Stryker, a leading maker of medical devices, and the United States attorney’s office in Boston, which is conducting the inquiry, declined to comment. A spokeswoman for the attorney’s office said the investigation was continuing.

The inquiry, which began last year, involves several issues, according to court papers and Stryker filings with the Securities and Exchange Commission. The questions include whether Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for “humanitarian” reasons, according to the documents.

Ban on Painkiller Darvon Is Recommended to F.D.A.
By THE ASSOCIATED PRESS
Published: January 30, 2009

Government medical advisers recommended a ban on Darvon, a prescription drug that has been used to treat pain for more than 50 years but has been linked to addiction. An advisory panel to the Food and Drug Administration voted 14 to 12 to recommend its withdrawal. The F.D.A. is not required to follow such recommendations, but often does.

Darvon, approved in 1957 and now mainly marketed as Darvocet, is one of the 25 most commonly prescribed medications. Public Citizen had petitioned the F.D.A. to withdraw Darvon, saying the drug offered relatively weak pain relief and posed an overdose risk. Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, which market the drug, say the medication is safe and effective when used as directed.

Court Reinstates Suits Over Pfizer’s Drug Testing
By REUTERS
Published: January 30, 2009

A federal appeals court reinstated lawsuits brought by Nigerian families who say the drug maker Pfizer tested a dangerous antibiotic on their children without their consent. The United States Court of Appeals for the Second Circuit in Manhattan, in a 2-to-1 ruling, overturned a lower court’s finding that the cases, involving the drug Trovan, should be heard in Nigeria, not the United States.

In 1996, Pfizer conducted clinical trials of the drug in Nigeria during a meningitis epidemic. Families of some of the children who participated say the tests caused deaths and injuries. In its ruling, the appeals court sent the United States cases back to a federal trial court for further consideration. Pfizer said the ruling was “procedural” and did not address the merits of the cases. It said the study had been done with the approval of the Nigerian government, which is also suing Pfizer, and had the consent of participants’ parents or guardians.

By THE ASSOCIATED PRESS
Published: January 27, 2009

HARTFORD (AP) — A former executive of the insurance giant American International Group was sentenced to four years in prison Tuesday in a fraud case that authorities say cost shareholders more than $500 million. The executive, Christian Milton of Wynnewood, Pa., was sentenced by Judge Christopher F. Droney of Federal District Court in Hartford. He was also fined $200,000.

Mr. Milton declined to speak during the hearing but his lawyers said they were preparing an appeal. He was ordered to report to the federal Bureau of Prisons on March 25. Mr. Milton, 61, A.I.G.’s vice president for reinsurance from 1982 to 2005, was convicted last year of conspiracy, securities fraud, mail fraud and making false statements to the Securities and Exchange Commission. The investigation also led to the convictions of four executives of General Re last year for their roles in manipulating A.I.G.’s financial statements.

By GARDINER HARRIS
Published: January 27, 2009

Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.

“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!” states the letter, which was provided to The New York Times. “It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

Heidi Rebello, an F.D.A. spokeswoman, said she could neither confirm nor deny the existence of a criminal investigation.

The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.

The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.

Three weeks ago, the scientists wrote a similar letter to the president-elect’s transition team. And on Monday, the scientists wrote another letter to President Obama.

Confidential agency documents, which include both e-mail messages and medical reviews detailing the internal dispute were provided to The Times.

It can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products.

Some of the scientists’ claims about the agency’s device approval process were echoed in a report released two weeks ago by the Government Accountability Office that was also critical of the agency’s device center.

Created in 1976, the F.D.A.’s process for approving devices divides the products into three classes and three levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called Class I devices and are largely exempt from agency reviews. Mercury thermometers are among Class II devices, and most get quick reviews. Class III devices include pacemakers and replacement heart valves, and Congress mandated that manufacturers of Class III devices must prove through extensive testing that their products are safe and effective.

But the accountability investigators found that the agency still allowed manufacturers of most Class III devices to gain approval without conducting extensive testing. Part of the reason may be that some Class III devices should be reclassified as Class II devices, while other such devices simply should be tested more.

The agency has promised for years to fix its device approval process but cannot say when the fix will be completed.

Critics have long bemoaned the agency’s device approval process, which allows most devices to be approved with minimal testing. Manufacturers say the agency is already overly restrictive.

With internal, Congressional and perhaps now criminal investigations swirling about the agency’s device division, the controversy regarding device approvals appears only to be worsening. In Monday’s letter to Mr. Obama, the nine scientists provided a detailed list of laws that they claim agency officials have violated.

“We are asking for your immediate intervention,” the letter to Mr. Obama stated.