Ex-sleuths sue GlaxoSmithKline over imprisonment in China
Signage for GlaxoSmithKline is seen on it’s offices in London, Britain, March 30, 2016. REUTERS/Toby Melville/File Photo
Two former corporate investigators have sued GlaxoSmithKline, alleging the drugmaker misled them and induced them to investigate an innocent person, resulting in their imprisonment.
The complaint, filed with the U.S. District Court in Philadelphia and made public on Wednesday, was brought by Peter Humphrey, who is British, and his American wife, Yu Yingzeng.
The couple were detained in 2013 and found guilty by a Chinese court in 2014 after being asked by GSK to investigate a whistleblower within the pharmaceuticals group.
They were convicted of illegally obtaining private records of Chinese citizens.
The couple allege GSK misled them by stating that the whistleblower’s allegations of widespread corruption within the company were false. GSK was fined a record 3 billion yuan ($436 million) in 2014 for paying bribes to doctors to use its drugs.
A GSK spokesman said: “We do not believe this case has any merit and will vigorously defend against the allegations.”
SHANGHAI — Peter Humphrey was in the bathroom of his Shanghai apartment when the police kicked the door off its hinges and knocked him to the ground. Nearly two dozen officers stormed his home. They confiscated files, laptops and hard drives related to his work as a corporate investigator.
Mr. Humphrey and his wife, Yu Yingzeng, were taken to Building 803, a notoriously bleak criminal investigation center normally reserved for human smugglers, drug traffickers and political activists. Sleep-deprived and hungry, he was transferred later that day to a detention house, placed in a cage and strapped to an iron chair. Outside, three officers sat on a podium and demanded answers.
Mr. Humphrey knew the reason for the harsh interrogation. He and Ms. Yu had been working for GlaxoSmithKline, the British pharmaceutical maker under investigation in China for fraud and bribery.
The Glaxo case, which resulted in record penalties of nearly $500 million and a string of guilty pleas by executives, upended the power dynamic in China, unveiling an increasingly assertive government determined to tighten its grip over multinationals. In the three years since the arrests, the Chinese government, under President Xi Jinping, has unleashed the full force of the country’s authoritarian system, as part of a broader agenda of economic nationalism.
Driven by the quest for profits, many multinationals pushed the limits in China, lulled into a sense of complacency by lax officials who eagerly welcomed overseas money. Glaxo took it to the extreme, allowing corruption to fester.
When bribery accusations surfaced, the company followed the old playbook, missing the seismic changes reshaping the Chinese market. Rather than fess up, Glaxo tried to play down the issues and discredit its accusers — figuring officials wouldn’t pay attention.
Along the way, there were bribes of iPads, a mysterious sex tape and the corporate investigator, who gave his operations secret code names. The company’s missteps are laid bare in emails, confidential corporate documents and other evidence obtained by The New York Times, as well as in interviews with dozens of executives, regulators and lawyers involved in the case.
The aftershocks of the Glaxo case are still rippling through China. The authorities have unleashed a wave of investigations, putting global companies on the defensive. The government has intensified its scrutiny of Microsoft on antitrust matters this year, demanding more details about its business in China. And just two weeks ago, the authorities detained a group of China-based employees, including several Australian citizens, working for the Australian casino operator Crown Resorts, on suspicion of gambling-related crimes.
Companies are racing to find new strategies and avoid getting locked out of China, the world’s second-largest economy after the United States. Disney and Qualcomm are currying favor with Chinese leaders. Apple redid its taxes in China after getting fined. Some multinationals are training employees in how to deal with raids.
The crackdown has prompted a complete rethinking for Glaxo — and for much of the pharmaceutical industry. To appease the government, drug makers have promised to lower prices and overhaul sales practices.
“For a long time, there’d been this policy of going easy on foreign enterprises,” said Jerome A. Cohen, a longtime legal adviser to Western companies. “The government didn’t want to cause embarrassment or give outsiders the impression that China is plagued with corruption. But they’re not thinking like that anymore.”
The Glaxo case was fueled by missed clues, poor communication and a willful avoidance of the facts. For more than a year, the drug maker brushed aside repeated warnings from a whistle-blower about systemic fraud and corruption in its China operations.
The company’s internal controls were not robust enough to prevent the fraud, or even to find it. Internally, the whistle-blower allegations were dismissed as a “smear campaign,” according to a confidential company report obtained by The Times.
Glaxo just wanted to make its problems go away. It offered bribes to regulators. It retaliated against the suspected whistle-blower. It hired Mr. Humphrey and Ms. Yu to dig into the woman’s background, family and government ties, as a way to discredit her. And Glaxo may even have gone after the wrong person, documents and emails obtained by The Times suggest.
None of it mattered. The allegations were true.
Prosecutors charged the global drug giant with giving kickbacks to doctors and hospital workers who prescribed its medicines. In 2014 Glaxo paid a nearly $500 million fine, at the time the largest ever in China for a multinational. Five senior executives in China pleaded guilty, including the head of Glaxo’s Chinese operations, a British national, in a rare prosecution of a Western executive. With Glaxo embroiled in scandal, sales plummeted in China, the company’s fastest-growing market.
Glaxo has declined multiple requests for comment, referring instead to earlier statements. Glaxo “fully accepts the facts and evidence of the investigation, and the verdict of the Chinese judicial authorities,” one statement read. “GSK P.L.C. sincerely apologizes to the Chinese patients, doctors and hospitals, and to the Chinese government and the Chinese people.”
Mr. Humphrey and Ms. Yu, both in their late 50s at the time of their arrests, were punished too. The couple spent two years in prison for illegally obtaining government records on individuals.
Mr. Humphrey was crowded into a cell with a dozen other inmates. There were no beds or other furniture, just an open toilet and a neon light overhead. During his incarceration, Mr. Humphrey said, he suffered back pain, a hernia and a prostate problem that was later diagnosed as cancer.
“I was in a state of complete shock and breakdown,” said Mr. Humphrey, who was released along with his wife in July 2015. “I was physically broken down and mentally blown away. I didn’t sleep for 45 days.”
A Whistle-Blower Emerges
An anonymous 5,200-word email in January 2013 to the Glaxo board laid out a detailed map to a fraud in the Chinese operations.
Written in perfect English, the email was organized like a corporate memo. Under the header “Conference Trip Vacations for Doctors,” the whistle-blower wrote that medical professionals received all-expenses-paid trips under the guise of attending international conferences. The company covered the costs of airline tickets and hotel rooms, and handed out cash for meals and sightseeing excursions.
In a section labeled “GSK Falsified Its Books and Records to Conceal Its Illegal Marketing Practices in China,” the email explained how Glaxo was pitching drugs for unapproved uses. As an example, the whistle-blower said the drug Lamictal had been aggressively promoted as a treatment for bipolar disorder, even though it had been approved in China only for epilepsy.
Glaxo “almost killed one patient by illegally marketing its drug Lamictal,” said the email, which was obtained by The Times. “GSK China bought the patient’s silence for $9,000.”
The email was one of nearly two dozen that the whistle-blower sent over the course of 17 months to Chinese regulators, Glaxo executives and the company’s auditor, PricewaterhouseCoopers.
When the authorities pressed Glaxo, the company was dismissive. It failed to properly investigate the allegations. It didn’t beef up its internal controls. And it didn’t change its marketing practices.
The decision was calculated. In the decades since China began opening its economy, most multinationals had avoided scrutiny over bribery. China needed overseas companies to help develop its economy, by setting up manufacturing operations and creating jobs. The authorities were reluctant to jeopardize investment, so they took a softer approach to enforcement.
When companies did run into trouble, fines were tiny. The rare cases tended to be colored by politics. Seven years ago, the Chinese authorities detained executives from the global mining giant Rio Tinto on suspicion of stealing state secrets. The charges were eventually downgraded to bribery, and the company avoided punishment.
By the time Glaxo’s fraud bubbled to the surface, China had changed.
Over the last decade, China has emerged as an economic powerhouse, but it took off even more as the rest of the world slowed after the financial crisis. That gave China the upper hand with overseas companies, which were increasingly dependent on profits from the country’s growing consumer base.
The economic might coincided with the Communist Party’s increasingly nationalistic stance. The authorities in China, already undertaking a severe crackdown on Chinese companies, wanted to show that, like American regulators, they could also penalize and sanction global companies.
And it was no secret that big drug makers were violating the law in China.
Years earlier, the consulting firm Deloitte warned about rampant corruption in China’s pharmaceutical market. As Deloitte found, doctors and health care workers were poorly compensated, so they could easily be induced to write more prescriptions with offers of cash, gifts, vacations and other benefits. Big drug makers, eager for growth, willingly obliged.
“The remarkable thing is that China is a more hospitable environment to this type of corruption, because it’s a market where doctors and hospitals are heavily reliant on drug sales,” said Dali Yang, who teaches at the University of Chicago and has studied the industry. “They were like fish swimming in water.”
American investigators had punished several major drug companies for such behavior abroad. In 2012, Eli Lilly agreed to pay $29 million, and Pfizer $45 million, to settle allegations that included employees’ bribing doctors in China. In settling the cases, neither company admitted or denied the allegations.
That summer, Glaxo agreed to pay $3 billion in fines and pleaded guilty to criminal charges in the United States for marketing antidepressants for unapproved uses, failing to report safety data on a diabetes drug and paying kickbacks. The case was built off tips from several whistle-blowers.
After that, Glaxo’s chief executive, Andrew Witty, pledged, “We’re determined this is never going to happen again.”
But it did — in China.
In early 2013, Glaxo realized it couldn’t ignore the problems. The authorities were asking questions. The whistle-blower continued to send emails.
So the company tried another common gambit in China: bribing officials.
The company set up a special “crisis management” team in China and began offering money and gifts to regulators.
That strategy had worked in the past. A company, often using a middleman, would try to soothe officials and regulators, offering gifts and favors.
One government agency had received multiple emails from the whistle-blower, and Glaxo targeted multiple branches of the agency, according to state media reports. One executive tried to cozy up to a Shanghai investigator with an iPad and a dinner totaling $1,200, another Glaxo employee said in a statement to the police. When that executive asked for money to bribe the Beijing branch, Mark Reilly, the head of the company’s Chinese operations, gave the “go ahead.”
Another executive with Glaxo’s Chinese operations bribed regulators to focus on “unequal competition,” rather than a more punitive investigation into “commercial bribery.” The goal, that executive admitted in a statement, was to limit any potential fine to about $50,000. It didn’t work.
As pressure mounted, the case took a bizarre turn, setting Glaxo on a collision course with the government.
In March 2013, Glaxo’s chief executive and five other senior executives in the company’s London headquarters received an anonymous email with a media file. In it, a grainy video showed Mr. Reilly, the executive in China, engaged in a sexual act with a young Chinese woman.
The attached email alleged that Mr. Reilly, a British national who had helped manage the company’s China operation for four years, was complicit in a bribery scheme tied to a travel agency called China Comfort Travel, or C.C.T. According to the email, Glaxo funneled money through the travel agency to pay off doctors. The travel agency also supplied Mr. Reilly with women, as a way to secure that business.
“In order to acquire more business, C.C.T. bribed Mark Reilly, the general manager of GSK (China) with sex,” the email said. “Mark Reilly accepted this bribery and made C.C.T. get the maximized benefits in return.”
Glaxo later discovered that the video had been shot clandestinely, in the bedroom of Mr. Reilly’s apartment in Shanghai. Analysts working for the company said it had been edited to disguise the location.
Glaxo executives in London were shocked. They deemed the video a serious breach of privacy, involving a possible break-in at the home of a senior executive in China. Mr. Reilly moved to a more secure residence.
Like many global companies, Glaxo has a code of conduct that encourages employees to report fraud or wrongdoing without fear of retaliation by the company. In many countries, including China, the rights of whistle-blowers are protected by law.
Glaxo didn’t seem to care.
By the time the video surfaced, Glaxo already had its suspicions about the identity of the whistle-blower. Months earlier, the company had fired Vivian Shi, a 47-year-old executive handling government affairs in Glaxo’s Shanghai office. The official reason for Ms. Shi’s firing was falsifying travel expenses. In fact, she was dismissed because the company believed she was the whistle-blower, according to confidential corporate documents obtained by The Times.
Ms. Shi did not return multiple calls for comment.
After receiving the video, Glaxo took more aggressive action, seeking to discredit Ms. Shi, who had already left the company.
At that point, in the spring of 2013, the company turned to Mr. Humphrey, the investigator. He ran ChinaWhys, a small risk consultancy firm that advised global companies like Dell and Dow Chemical.
His firm was engaged in what he called “discreet investigations,” helping multinationals cope with difficult situations like counterfeiting and embezzlement. Short in stature, with a shock of white hair, Mr. Humphrey portrayed himself as a kind of modern-day Sherlock Holmes.
“He likes a good adventure and likes solving cases,” said his friend Stuart Lindley, who runs a financial services company in China. “But he was definitely aware that some of that stuff was risky.”
In April 2013, Mr. Reilly met with Mr. Humphrey at Glaxo’s glass office tower near People’s Square in central Shanghai. According to meeting notes obtained by The Times, they discussed the emails, the sex video and Ms. Shi, the suspected whistle-blower. Mr. Reilly told the investigator that she held a grudge against Glaxo.
At the meeting, Mr. Reilly asked the investigator to look into the break-in at his apartment. But he made clear that he also wanted to assess what power and influence Ms. Shi might have with the government.
Legal experts say Mr. Reilly should not have been put in charge.
“The executive so accused has an obvious conflict of interest in overseeing such an investigation,” said John Coates, a Harvard Law School professor. “Even if the executive were entirely innocent of the whistle-blower’s charge, giving that same executive the role of investigating the whistle-blower smacks of retaliation.”
Efforts to reach Mr. Reilly, who has since left the company, were unsuccessful.
Using the code name Project Scorpion, Mr. Humphrey and his staff spent the next six weeks working undercover, gathering evidence. They visited Lanson Place, the upscale apartment complex where Mr. Reilly lived when the sex tape was made. They created a dossier on the suspected whistle-blower, searching for motives and ties to high-ranking officials or regulators. They interviewed former co-workers, scrutinized her résumé and scoured the web for information about her father, a former health official.
Glaxo may have crossed a line in this regard, putting the company more sharply in the government’s sights.
As part of the investigation, Mr. Humphrey turned to a Chinese detective to acquire a copy of Ms. Shi’s household registration record, or hukou. The official document contained information about her husband and daughter. The authorities had warned private detectives about acquiring confidential government documents.
“This type of household information is supposed to be private,” said John Huang, a former government official who is now managing partner at McDermott, Will & Emery in Shanghai. “But people were buying and selling it.”
Glaxo got little payoff from the investigation.
On June 6, 2013, Mr. Humphrey delivered a 39-page report to Glaxo that said Ms. Shi was probably the whistle-blower and even had a “track record of staging similar attacks” at a previous job. But the report included no evidence linking her to the emails or the sex video, according to a draft obtained by The Times.
Glaxo’s strategy of bribery and discrediting ultimately failed.
With the Chinese government in the midst of a crackdown on corruption, the police carried out a series of raids on June 27, 2013. They seized files and laptops from multiple Glaxo offices and interrogated dozens of employees. In Shanghai, four senior executives were detained. Investigators also raided the offices of several travel agencies that had worked closely with Glaxo, including China Comfort Travel.
A week later, the police stormed Mr. Humphrey’s apartment in Shanghai. He and his wife were charged with violating privacy laws.
Mr. Humphrey declined to comment on the specifics of the Glaxo case. His son defended his work, saying Glaxo engaged him “under false pretenses.” “My father is an honorable and law-abiding man,” said the son, Harvard Humphrey.
When prosecutors announced the case against Glaxo in July 2013, several weeks after arrests began, their allegations closely mirrored those of the whistle-blower. They described an elaborate scheme to bribe doctors and workers at government-owned hospitals using cash that had been funneled through a network of 700 travel agencies and consulting firms.
“It’s like a criminal organization: There’s always a boss, and in this case GSK is the boss,” said Gao Feng, one of the lead investigators.
Glaxo said little about the developments until July 15, when several high-ranking executives confessed from prison on state-run television. After that, the company capitulated, issuing a blanket statement for its misdeeds: “These allegations are shameful and we regret this has occurred.”
Cleaning Up Corruption
Dressed in a dark suit and a blue tie, Mr. Reilly, the Glaxo executive, was led in handcuffs into a small courtroom in the city of Changsha, in central China, in September 2014. With security guards behind him, he stood alongside four other senior Glaxo executives as a judge read the charges.
“The defendant company GSKCI is guilty of bribing nongovernment personnel and will be fined 3 billion yuan,” the judge, Wu Jixiang, said sternly, referring to Glaxo’s Chinese name. The company and the executives, having confessed, were given relatively light sentences, the court said.
Mark Reilly was sentenced to three years in prison and ordered to be expelled from China.
After handing down that sentence, the judge turned to Mr. Reilly.
“Do you obey the court’s verdict? Do you appeal?” he asked.
Mr. Reilly said that he would not challenge the verdict. Because he was swiftly deported, he will not serve prison time in China.
Glaxo is still trying to clean up the mess.
In China, Glaxo has promised to overhaul its operations and has put in place stricter compliance procedures. The company has changed the way its sales force is compensated and has eliminated the use of outside travel agencies.
Glaxo has also tightened oversight of expenses and cash advances, areas central to the case. Employees must now send in photographs of the guests and food, to verify that the meetings took place.
And in August 2015, Glaxo tried to make amends by rehiring Ms. Shi, an acknowledgment that the company had erred in firing an employee suspected of being a whistle-blower.
But the decision also hinted at a more troubling admission — that Glaxo had targeted the wrong person. There are indications that Ms. Shi was not the whistle-blower, and that there may have been more than one person.
The emails sent to regulators were written in fluent English and came mostly from a Gmail account. The email with the sex video came from a local Chinese account and was written in poor English. The only similarity was the anonymity.
The Times sent emails to both accounts and got a response from just one, the person who had written the detailed emails to the Chinese authorities and Glaxo. “You have reached who you are looking for,” the person replied.
In a series of exchanges, the author denied being Ms. Shi, acting in concert with her or sending the video. The person said Glaxo had erroneously blamed Ms. Shi for the emails and never found the actual whistle-blower.
The Times was unable to verify the identity of the person, who described working in Shanghai but declined to come forward for fear of retribution.
“I didn’t reveal to GSK personnel that I was the whistle-blower because doing so would have placed me in potential physical jeopardy,” the whistle-blower wrote in an email to The Times. “You understand that criminals — you know that they were convicted later in Chinese courts — were in charge of GSK China at that time, and I truly believe that they would have harmed me in some fashion had they discovered my identity. ”
After a whistle-blower working for one of the world’s biggest pharmaceutical companies began sending anonymous tips about fraud and corruption inside its operation in China, authorities there moved in. They arrested top executives and corporate detectives the company had hired to track down the whistle-blower. Here is how the events transpired.
Credit Aly Song/Reuters
December 2011 A self-described whistle-blower working inside Glaxo sends an email to Chinese regulators, detailing fraud and corruption in the pharmaceutical maker’s Chinese operations. It is the first of about two dozen emails sent over a 17-month period.
April 2012 Glaxo executives in China begin hearing that a whistle-blower has been sending documents to Chinese regulators claiming widespread corruption at the company.
July 2012 The company pleads guilty in the United States to criminal charges for improper drug marketing and kickbacks to doctors. The company’s chief executive, Sir Andrew Witty, pledges that it “is never going to happen again.”
December 2012 Vivian Shi, the head of government affairs for Glaxo in China, is fired, supposedly for falsifying travel expenses. But the real reason, according to internal documents, is that Ms. Shi is suspected of being the whistle-blower.
January 2013 The whistle-blower sends a 5,200-word email to the Glaxo chairman, senior executives and the company’s outside auditor. The email, like the previous ones to authorities, describes a systemic fraud and bribery scheme. The allegations are dismissed by the company as a “smear campaign.”
“This illegality almost killed a person,” a whistle-blower wrote to Chinese regulators in January 2013.
March 2013 Top Glaxo executives in London receive another whistle-blower email, this time showing Mark Reilly, the head of the company’s operations in China, engaged in a sexual act in his apartment.
April 2013 Glaxo hires ChinaWhys, a private consulting firm run by Peter Humphrey and his wife, Yu Yingzeng, to investigate the suspected whistle-blower and a break-in at Mr. Reilly’s home. The investigation is code-named “Project Scorpion.”
June 2013 Mr. Humphrey presents the findings of his investigation to Glaxo. Although his report offers no evidence connecting Ms. Shi to the emails, he notes the suspected whistle-blower has a “track record of staging similar attacks.”
June 2013 The police carry out a series of coordinated raids on Glaxo offices throughout China, detaining four executives, including the country’s chief legal officer. Several travel agencies working closely with Glaxo are also raided.
July 15, 2013 At a news conference in Beijing, prosecutors accuse senior executives at Glaxo’s Chinese operations of running an elaborate scheme to bribe doctors and hospital workers, describing it as an “organized crime operation.”
July 16, 2013 Four Chinese executives at Glaxo confess on state television to the bribery and fraud scheme.
August 2014Mr. Humphrey and Ms. Yu are convicted of illegally obtaining government records about individuals during their corporate investigations, a charge they denied. They each served two years in prison.
Sept. 19, 2014 At a one-day trial held in secret, Mr. Reilly, the head of Glaxo’s Chinese operations, and other company executives plead guilty to fraud and bribery. Glaxo agrees to pay a $500 million fine. Mr. Reilly is deported from China.
The U.K. pharmaceutical giant GlaxoSmithKline has resolved an outstanding FCPA matter for the conduct of its China subsidiary, GSK-China that settled an SEC investigation for a fine of $20 million, with no profit disgorgement—quite a favorable move for the company. Even more amazingly, the company received a declination from the Justice Department, even though it was under the equivalent of a Deferred Prosecution Agreement, called a Corporate Integrity Agreement, for the actions unrelated to its FCPA violations in marketing off-labeled marketed products.
Of course these resolutions did not stand alone as the company had been sanctioned by the Chinese government with a fine of approximately $490 million back in 2014 for the actions of GSK-China. Company employees were criminally convicted and non-Chinese senior executives of the China business unit, who were convicted were deported from China. GSK’s sales in China went in the tank and continue to suffer through this date.
Perhaps the U.S. authorities felt the company had suffered enough. However, in this age of increasing international enforcement, it may well be the SEC and Justice Department missed an opportunity to demonstrate how they would give credit for anti-corruption prosecutions, done by other governments, under local anti-corruption laws; such as was done by Chinese authorities with GSK-China. U.S. authorities could have not only cited to the successful use of domestic Chinese laws as an example in the international fight against bribery and corruption but also specifically stated that how the fine and penalty paid by GSK-China was considered in the calculation of the fine by U.S. regulators.
Such an approach would have emphasized the U.S. government’s favorable outlook for greater international sanctions against corruption, as well as shown companies that they would not be whip-sawed by regulators across the globe for the same conduct. It could have been one of the most public examples of how the U.S. government viewed the international fight against corruption.
Victims suffering side effects from cervical cancer vaccines that were once recommended by the government announced Wednesday they will file a lawsuit against the state and drugmakers.
“Many victims are still suffering from side effects of the human papillomavirus (HPV) vaccines Cervarix and Gardsil, which include overall pain and disorders of perception, movement and memory,” lawyer Masumi Minaguchi, a representative from the planned lawsuit’s defense team told a news conference in Tokyo.
Minaguchi said the victims will file the suit sometime after June against the central government, GlaxoSmithKlien PLC, the maker of Cervarix, and Merck Sharp & Dohme Corp., the maker of Gardsil, at four district courts in Tokyo, Nagoya, Osaka and Fukuoka.
“The victims wish to live a peaceful life and prevent further suffering by finding out the truth (about the vaccine side effects),” Minaguchi added.
She said the defense team will seek additional plaintiffs to join the lawsuit by holding seminars in April and May. Currently, 12 plaintiffs are taking part in the suit, according to Minaguchi.
Saitama Prefecture resident Nanami Sakai, who plans to be one of the plaintiffs, was one of four to attend the news conference. The 21-year-old, who was given Cervarix twice in 2011, said she did not receive information about the pros and cons of the vaccine before receiving the injections.
“I’d like to know why I was left scarred by the vaccine, why I was not able to receive proper treatment right away and why my situation was not adequately conveyed to the state,” Sakai said.
Sitting in a wheelchair, Sakai said she has numbness in the right side of her body, back and around her chest.
Yui Taniguchi, who suffers from a number of symptoms including severe headaches and occasional loss of vision, said she decided to join the suit in order to show that there are many people whose lives have been turned upside-down by the vaccines’ side effects.
“I felt I needed to speak out so that we won’t see another such victim in the future,” Taniguchi, a 17-year-old high school student from Nara Prefecture, said at the news conference.
Cervical cancer is caused by the human papillomavirus, which is transmitted mainly through sexual intercourse. The cervical cancer vaccines are believed to help prevent HPV.
According to health ministry figures, 2,022 people suffered side effects out of an estimated 2.59 million who had received injections of Cervarix by the end of 2014. Out of an estimated 790,000 people given Gardasil 453 experienced side effects.
In April 2013, after the Diet revised the Preventive Vaccination Law, the health ministry began recommending that girls between the ages of 12 and 16 be vaccinated.
However, the ministry halted the recommendations in June that year following a number of cases involving reported side effects.
The health ministry says about 9,000 women in Japan develop cervical cancer each year and around 2,700 die from the disease.
Thanks to the U.S. Justice Dept. complaint in the suit recently settled by GlaxoSmithKline for a record $3B: http://www.justice.gov/opa/documents/gsk/us-complaint.pdf
–we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes.
Study 329, directed by Dr. Martin Keller of Brown University, was one of 3 clinical studies in children and adolescents that were all interpreted by GSK scientists between August and October, 1998 to be discouraging. Study 329’s protocol specified two primary endpoints, and on neither measure did Paxil do better than placebo. The study also logged in 11 serious adverse reactions to Paxil, much more than in the placebo group, including 5 with agitated or suicidal behavior, the major risk for which eventually the FDA issued a black-box warning for the SSRI class of antidepressants…”
Editorial Note: Following the publication of Study 329 Restored, Martin Keller and his co-authors gave an initial response in which they said Nobody Pinned Anything on Us and also that they would respond in more detail later. It took four months for this response to appear. Our Response will follow in the next post and after that we will update our background correspondence with BMJ.
This and earlier correspondence and all the data from the Study 329, BMJ reviews of the study, a timeline of the history of SSRIs and all controversies linked to these drugs is all available on Study329.org.
There are two further Study 329 articles making Study 329 the most intensively studied Clinical Trial ever. The Study 329 website will make all this material available for anyone who wants to see how clinical trials operate – this study is not an anomaly, it is standard industry practice.
The picture above was dubbed Three Amigos by its creator. It features Charlie Nemeroff, Marty Keller and Alan Schatzberg. A picture that is at least as appropriate is below linked to the conflict of interest declaration.
Martin B Keller, Boris Birmaher, M.D., Gabrielle A. Carlson, MD, Gregory N. Clarke, Ph.D., Graham J. Emslie, M.D., Harold Koplewicz, M.D., Stan Kutcher, M.D., Neal Ryan, M.D., William H. Sack, M.D., Michael Strober, Ph.D.
attn: Martin B Keller, MD, 700 Butler Drive, Blumer 120, Providence, RI 02906, USA
Re: Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Response from the authors of the original Study 329
The BMJ article entitled “Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence” reanalyzed data from the original Paroxetine 329 study, a double-blind placebo controlled comparison of paroxetine to imipramine. Paroxetine 329 was designed between 1991 and 1992. Subject enrollment began in 1994, and was completed in 1997. Academic psychiatrists designed the study, with very little change by GSK, which funded the study in an academic / industry partnership. The goal of the study was to advance the treatment of depression in youth, rather than primarily as a drug registration trial.
Overarching issues with the “Restoring Study 329” include:
Authors of “Restoring Study 329” evidenced both bias and a lack of blind ratings. In a recent article about “Restoring Study 329” in the Chronicle of Higher Education, Dr. Jureidini is quoted as saying: “We don’t think we’ve done the definitive analysis. It’s not something that can be done absolutely objectively, particularly the interpretation of harms. We can’t protect ourselves completely from our own biases.” Biases are a serious consideration for Restoring Study 329 because Dr. Jureidini, as he declares in a Footnote on the subject of “Competing interests”, served as an expert witness for plaintiff’s lawyers in legal suites against GSK related to Study 329. In that work Dr. Jureidini would have studied all available data looking at both efficacy and suicidal side effects, using many different approaches to best capture any potential harms.
The “restoring invisible and abandoned trials” (RIAT) approach to reanalyzing published studies may provide general guidelines but we could not find publications or available working RIAT documents on detailed protocols. Lack of detailed methodology is a serious concern because there is general consensus in the field that there is not, nor never will be a single correct approach to reanalysis. Small differences in analysis frequently make big differences in statistical results and conclusions.
“Restoring Study 329” did not consider available knowledge 24 years ago, when Paroxetine 329 was developed and performed. Clinical research methodology has evolved considerably in the past two decades. These aspects are addressed in comments by established investigators not involved in Paroxetine 329. For example, Referring to “Restoring Study 329” as reported in Psychiatric News Alert  Mark Olfson said, “However, the new reanalysis does not alter the totality of clinical trial evidence that continues to support the safety and efficacy of SSRIs for adolescent depression.” And Daniel Pine said “We have known for some time that antidepressant medications have both significant benefits for some children as well as significant risks for other children. This new analysis really does nothing to change this knowledge, and provides no new insights into what we have known about these medications for the past few years.”
Antidepressants considered as a group are superior to placebo for the treatment of anxiety disorders and for depression in adolescents, with similar overall response rates in anxiety and depression. 
The two primary outcome measures in Paroxetine 329, did not reach statistical significance. The abstract of the published paper noted: (1), “The two primary outcome measures were endpoint response (Hamilton Rating Scale for Depression [Ham-D] score ≤ 8 or ≥50% reduction in baseline HAM-D) and change from baseline HAM-D score.” In Table 2, the p value for the first primary endpoint (Ham-D score ≤ 8 or ≥50% reduction in baseline HAM-D) was reported at p < 0.11 for paroxetine versus placebo. In the same table, the p value for change in HAM-D total score is reported at p < 0.13. While both outcomes were in the direction of a better response for paroxetine over placebo; neither reached our critical alpha level of 0.05. This is clear in the abstract and text of the publication.
In the interval from when we planned the study to when we approached the data analysis phase, but prior to the blind being broken, the academic authors, not the sponsor, added several additional measures of depression as secondary outcomes. We did so because the field of pediatric-age depression had reached a consensus that the Hamilton Depression Rating Scale (our primary outcome measure) had significant limitations in assessing mood disturbance in younger patients. Taking this into consideration, and in advance of breaking the blind, we added secondary outcome measures agreed upon by all authors of the paper. We found statistically significant indications of efficacy in these measures. These secondary outcomes were clearly reported as separate from the negative primary outcomes.
Thus, the authors of “BMJ-Restoring Study 329” were incorrect in stating that “Both before and after breaking the blind, however, the sponsors made changes to the secondary outcomes as previously detailed. We could not find any document that provided any scientific rationale for these post hoc changes and the outcomes are therefore not reported in this paper.” Rather, secondary outcomes were decided by the authors prior to the blind being broken. Secondary outcome measures are frequently, and appropriately, included in study reports even when the primary measures do not reach statistical significance. The authors of “Restoring Study 329” state “there were no discrepancies between any of our analyses and those contained in the CSR [clinical study report]”. The disagreement on treatment outcomes rests on this arbitrary and non-blind dismissal of our secondary outcome measures.
In the abstract we stated “Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.” In this sample and with the state of knowledge at the time, it was justified and appropriate.
Our goal was to learn as much as possible about the use of this compound in youth, so that we could understand what role it (and by extension other SSRIs) could play in the treatment of adolescents with MDD. For us the question was given (1) the data distribution and statistical results for efficacy and side effects that we saw in the study, and (2) that there was well replicated research evidence of efficacy and relative safety of paroxetine in adults, what conclusions should be drawn from our data? The clinical outcomes were substantially in the right direction, with a number of them reaching the 0.05 level of statistical significance. The clinical results comparing paroxetine placebo to and imipramine to placebo paralleled those reported in adults. Side effects were similar to what was known in adults. Thus we reached, the conclusions reported.
The “Restoring Study 329” reanalysis uses the FDA MedDRA approach to side effect data, which was not available when our study was done. That one can do better reanalyzing adverse event data using refinements in approach that have accrued in the 15 years since a study’s publication is unsurprising and not a valid critique of Paroxetine 329 study as performed and presented.
We emphatically disagree with the “Restoring Study 329” position that statistics are not useful in understanding adverse side effects and that each individual reader should decide for herself when a difference in rates of adverse side effects is meaningful. Statistics offer several approaches to the question of when is there a meaningful difference in the side effect rates between different treatments.
Specific methodology problems in the reanalysis of the “harm” data are as follows: 1) The authors choose a non-random subsample of 85 subjects who were withdrawn from the study plus 8 subjects whom the authors labeled “suicidal” based on their inspection of the data; 2) a different instrument was utilized to re-score the harm effects and only one of the authors was trained in the scoring of the instrument; 3) some side effects were arbitrarily interpreted (e.g., upper respiratory symptoms were labeled as “dystonia” and emotional lability labeled as “suicidality”); 4) in the original paper, side effects were analyzed only during the acute phase, but in the reanalysis, the authors analyzed them during the acute phase, as well as the tapering and follow up phases of the study; and 5) in the original study patients were interviewed face-to-face whereas the reanalysis was based only on the interpretation of the data; and 6) importantly, the two authors were not blind to patients’ randomization status.
Suicidal ideation and attempts
Our field’s understanding of how to approach analysis of suicidal ideation, suicide attempts, and completed suicide has advanced enormously since publication of study 329. Two definitive reanalyses of the suicidality with antidepressants in adolescents include: 1). The 2003 FDA reanalysis of all RCT data of SSRI studies in youth for all indications. In the FDA analysis the average risk ratio for SSRI versus placebo treated subjects was 1.96 (CI: 1.28-2.98). Considered separately Study 329 did not reach statistical significance for increased suicidality (CI: 0.42-33.21). 2). The methodologically superior reanalysis by Bridge and colleagues also found that in study 329 there was no significant risk difference between paroxetine and placebo. 
Paroxetine treatment in youth does not appear to significantly differ from other SSRIs in the risk of suicidal ideation or attempts and whether SSRIs increase or decrease completed suicide remains an open question. [8-12]
We strongly support efforts to make anonymized raw data from scientific studies available for reanalysis. The validity of “Restoring 329”, however, is doubtful because of author bias and substantial problems with RIATT methodology. To describe Paroxetine 329 as “misreported” is pejorative and wrong based on both state-of-the-art research methods 24 years ago, and retrospectively from the standpoint of current best practices.
Martin B. Keller, M.D. Boris Birmaher, M.D. Gabrielle A. Carlson, MD Gregory N. Clarke, Ph.D. Graham J. Emslie, M.D. Harold Koplewicz, M.D. Stan Kutcher, M.D. Neal Ryan, M.D. William H. Sack, M.D. Michael Strober, Ph.D.
Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.
Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40(7):762-72.
Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. Jama 2007;297(15):1683-96.
Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006;63(3):332-9.
Bridge JA, Birmaher B, Iyengar S, et al. Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatry 2009;166(1):42-9.
Gibbons RD, Brown CH, Hur K, et al. Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry 2007;164(9):1356-63.
Olfson M, Shaffer D, Marcus SC, et al. Relationship between antidepressant medication treatment and suicide in adolescents. Arch Gen Psychiatry 2003;60(10):978-82. 10. Gibbons RD, Hur K, Bhaumik DK, et al. The relationship between antidepressant prescription rates and rate of early adolescent suicide. Am J Psychiatry 2006;163(11):1898-904. 11. Valuck RJ, Libby AM, Sills MR, et al. Antidepressant treatment and risk of suicide attempt by adolescents with major depressive disorder: a propensity-adjusted retrospective cohort study. CNS Drugs 2004;18(15):1119-32. 12. Gibbons RD, Mann JJ. Strategies for quantifying the relationship between medications and suicidal behaviour: what has been learned? Drug Saf 2011;34(5):375-95.
This picture comes from Carl Eliot based on Johanna Ryan’s noting a curious phrase in the conflict of interest statement from Gabrielle Carlsson below.
Competing interests: Please see attachments to this response – the attachments are available on Study329.org.
The high-profile fund manager tells Sky News a “fresh pair of eyes” is needed to replace Sir Andrew Witty at GSK.
10:58, UK, Thursday 17March 2016
Sir Andrew Witty poses after being honoured with a knighthood
By Mark Kleinman, City Editor
Britain’s biggest drugs-maker, GlaxoSmithKline (GSK), has been told to ignore internal candidates in its search for a new boss as shareholders intensify demands for a radical overhaul of the company.
Speaking exclusively to Sky News, Neil Woodford, the City’ s best-known fund manager, said that GSK needed “a fresh pair of eyes” to replace Sir Andrew Witty, who will step down next year.
“I have a strong preference for an external candidate,” the head of investments at Woodford Investment Management said on Thursday.
Mr Woodford’s demands will put pressure on Sir Philip Hampton, GSK’s new chairman, to appoint an executive from elsewhere in the pharmaceuticals industry to succeed Sir Andrew.
That would come as a blow to possible internal candidates such as Emma Walmsley, who runs GSK’s consumer products division, and Abbas Hussain, president of its global pharmaceuticals unit.
Sky News revealed last autumn that Mr Woodford was seeking a break-up of the £69bn company, which owns brands such as Nicorette and Horlicks.
He believes the group would be far more valuable if it separated its HIV business ViiV, its consumer healthcare division and Stiefel, its dermatology division, from its core medicines and vaccines arm.
The City has grown frustrated at GSK’s lacklustre share price performance, with the stock down about 10% over the last 12 months as investors wait to see whether a pipeline of promising new products will deliver.
Under Sir Andrew, its chief executive since 2008, GSK has signalled a shift away from highly priced prescription drugs in favour of vaccines and consumer products.
Analysts at Deutsche Bank said the announcement about Sir Andrew’s retirement was unlikely to signal material strategic changes at GSK.
GlaxoSmithKline CEO Andrew Witty to Retire in March 2017
March 17, 2016 — 7:12 AM GMT
Updated on March 17, 2016 — 12:10 PM GMT
Board will search for CEO candidate inside, outside drugmaker
Chairman Hampton also plans `board refreshment’ this year
GlaxoSmithKline Plc Chairman Phil Hampton began an overhaul of the biggest U.K. drugmaker by launching a search for Chief Executive Officer Andrew Witty’s successor and replacing a third of the board as he seeks to pacify some disgruntled investors.
Witty, 51, will retire next March, after almost a decade at the helm, the London-based company said in a statement on Thursday. Glaxo also plans what Hampton termed a “board refreshment” as directors Deryck Maughan, Stephanie Burns, Daniel Podolsky and Hans Wijers won’t stand for re-election at the annual meeting in May.
Photographer: Simon Dawson/Bloomberg
Witty, once hailed as one of the pharmaceutical industry’s most visionary managers, has faced criticism for Glaxo’s lagging share performance, sluggish sales and a pipeline lacking promising medicines. A bribery scandal in China that led to a $489 million fine last year also tarnished his image, which he had built with initiatives to develop the world’s first malaria vaccine and reform the way medicines are marketed to doctors.
“Glaxo needs a shakeup at the top,” said Gareth Powell, a portfolio manager at Polar Capital LLP in London whose holdings include Glaxo shares. “There’s a lack of truly innovative products, and that’s what they need to sort out.”
Last year, Witty oversaw the biggest reorganization since the merger that created Glaxo 15 years ago. He sold the company’s cancer drugs to Novartis AG in exchange for the Swiss firm’s vaccines business and cash. The companies also formed a joint venture, controlled by Glaxo, to sell consumer health products.
Glaxo shares fell 1.3 percent to 1,394 pence at 12:07 p.m. in London trading. The stock has returned an average of 10 percent a year over the past five years, compared with a 17 percent average annual return for the Bloomberg Europe Pharmaceutical Index.
“By next year, I will have been CEO for nearly ten years and I believe this will be the right time for a new leader to take over,” Witty said in the statement. He began leading Britain’s largest drugmaker in 2008 after more than 20 years at the company, including postings in the U.S., Asia and Africa.
Both internal and external candidates will be considered for the role. Glaxo investor Neil Woodford said he would like to see someone from outside the company take the top job. One of that person’s first tasks may be to slash the dividend, investors said.
Potential candidates include Emma Walmsley, head of Glaxo’s consumer-health division, and Abbas Hussain, president of its drug business, according to reports in U.K. media. Chief Financial Officer Simon Dingemans and Roger Connor, who oversees global manufacturing and supplies, may also be considered as internal successors. David Epstein, head of Novartis’s pharmaceutical unit, may also be approached, the reports said.
Witty’s views have diverged from those of his peers. He has avoided large-scale acquisitions that have consumed others such as Pfizer Inc. and Teva Pharmaceutical Industries Ltd. And in 2011, he started a program called Patient First that eliminated the link between sales targets and bonuses for Glaxo’s U.S. marketing team, following allegations of illegally promoting drugs. Few drugmakers followed his lead.
Glaxo’s sales declined to 23.9 billion pounds ($34.2 billion) last year from a peak of 28.4 billion pounds the year after Witty joined. Core earnings per share will probably surge this year, the company has said, after two years of declines.
“The decision will allow him to step aside at a high point following the company’s expected return to double-digit earnings growth in 2016,” Richard Parkes, an analyst at Deutsche Bank AG in London, wrote in a note to clients.
One bright spot has been Glaxo’s portfolio of HIV medicines, which the company considered spinning off in an IPO before opting to keep it. The British drugmaker also has one of the broadest drug pipelines in the industry, with more than 70 new medicines in development (though many are early-stage drugs that won’t deliver sales anytime soon), according to a Bloomberg Intelligence pipeline analysis.
A breakup of the company, favored by some investors including Woodford, might not generate that much value, according to an analysis by Bloomberg Intelligence analyst Sam Fazeli. Separating the drugs, vaccines and consumer-health units will probably increase Glaxo’s enterprise value of 83 billion pounds ($118 billion) by 10 percent or less, he estimated.
How does GSK get away with paying such low rates of corporation tax in the UK (or in some years such as 2014 -none at all)- despite claiming to be a UK company and despite the vast profits GSK generates globally?…
See the Guardian article (from 2009) under this latest one for more…
Six British multinationals ‘did not pay any UK corporation tax in 2014’
The same year, the six companies in the top 10 of the London stock exchange made a combined global profit of 30bn.
Six of Britain’s 10 biggest multinationals, including Shell, British American Tobacco (BAT) and Lloyds Banking Group, paid no UK corporation tax in 2014, an investigation has claimed.
The reports come after Chancellor George Osborne received a backlash over calling a “sweetheart deal” with tech giant Google, which was allowed to pay £130m for back taxes over the last decade, a “success”.
Lloyds, brewer SABMiller and drugs company AstraZeneca were also among the six multinationals not to have paid any coropration tax in 2014, reports the Sunday Times.
The same year, the six British companies made a combined global profit of £30bn.
British Petroleum (BP) and drugs company Glaxo Smith Kline (GSK) refused to reveal how much UK corporation tax they paid, but GSK declared it had paid some tax in 2014.
Tuesday 3 February 2009 00.01 GMT Last modified on Friday 8 January 2016 23.46 GMT
The title to more than 40 GlaxoSmithKline trademarks went to a factory in Puerto Rico, including the trademark for the top-selling diabetes drug Avandia.
The trademark for the newly launched breast cancer drug Tykerb was assigned to Ireland, another low-tax regime, in 2005, followed there by the firm’s Sensodyne toothpaste brand in January 2008.
In 2007, the Puerto Rico trademarks, including Avandia, were shifted on to the firm’s Irish operation in Cork. Glaxo’s production was phased out at SB Pharmco Inc in Puerto Rico after quality control problems.
The value of Glaxo’s trademarks, their intellectual property, has been estimated to constitute as much as 5% of the eventual selling price of a drug. The company explains in its most recent annual report: “Profits arising from certain operations in … Puerto Rico and Ireland are accorded special status and are taxed at reduced rates compared with the normal rates of tax in these territories. The effect increased earnings per share by 4.9p in 2007, 7.2p in 2006 and 2.7p in 2005.”
Helen Jones, Glaxo’s head of tax, told us: “It is a widespread and totally accepted practice for global companies to license out intellectual property in return for royalties which reflect the value of work carried out by the holder.”
Glaxo pays on average more than 80% of its tax to overseas countries rather than to Britain. Last year as a result, although the British official tax rate has been 30%, and Glaxo’s worldwide profits were £7.4bn, the company’s actual UK tax bill was only £450m. This is still a hefty sum, and it is to Glaxo’s credit that it declares its UK tax charge (although it still does not disclose how much UK tax is actually paid over in cash each year). But it is only a tiny fraction of the pharmaceutical giant’s profits particularly relevant to the amount of Glaxo’s initial research and development carried out by British scientists in Britain.
Glaxo says it is natural that most of its tax is paid overseas, where it has more than 80% of its 100,000 employees. The company claims more than 90% of its turnover is “not related to the company’s UK subsidiaries”. It is not clear how much more UK tax would be paid if the intellectual property created in the UK had been kept in the UK.
Glaxo has been embroiled in tax rows around the world, not only in the UK, but in Canada, Japan, and most of all the US, where it makes the most lucrative sales. In 2006, it finally agreed to pay the US £1.7bn to settle a huge dispute over sales of the ulcer drug Zantac and others produced in the Puerto Rico factories. The US claimed it was being cheated out of its fair share of global tax.
Transnational companies do sometimes find themselves caught in the middle of arguments between different countries about their respective share of the tax cake.
The US is also currently demanding another $680m, which Glaxo disputes, over attempts to deduct loan interest from Glaxo profits. The company was locked in a lengthy fight with the British tax authorities, described as being over “transfer pricing” and “controlled foreign company” issues, in which Glaxo was accused of piling up too many profits abroad.
Glaxo said last year that there were “wide differences in positions” between the company and HM Revenue & Customs, which might lead to litigation. But in June, the disputes were suddenly resolved “with no material impact on the expected tax rate for the year”.
This followed shortly after meetings between Glaxo executives and Gordon Brown, and public threats that Glaxo might relocate to the Republic of Ireland.
In 2006, Glaxo paid US £1.7bn to settle dispute over sale of drugs produced in Puerto Rico
More than five years ago, Reed Smith partner Stewart Dolin killed himself at a Chicago train station, leaving behind a wife, two children and a sucessful career. Now his widow has moved a step closer to trial in a case accusing GlaxoSmithKline LLC of hiding the suicide risks of its blockbuster antidepressant Paxil and contributing to Dolin’s death.
Wendy Dolin has been pursuing negligence and fraud claims against GSK since August 2012. About two years earlier, in July 2010, Stewart Dolin went to Chicago Transit Authority station on his lunch break and died after stepping in front of an oncoming train. A medical examiner deemed the death a suicide, and an autopsy confirmed the presence of a generic version of GSK’s antidepressant Paxil, according to court documents.
On Tuesday U.S. District Judge James Zagel in Chicago declined to rule on a pair of motions that GSK’s defense lawyers at King & Spalding and Dentons filed last year, hoping to scuttle the case before trial. In a brief docket entry, the judge explained that he won’t make a decision on GSK’s summary judgment motions before a trial scheduled to begin on Sept. 19.
Stewart Dolin, pictured right in an undated photo, was 57 and a co-chair of Reed Smith’s corporate and securities group when he died.
In the lawsuit, Wendy Dolin’s lawyers at Los Angeles-based personal injury firm Baum Hedlund Aristei Goldman allege that the suicide came just six days after the Reed Smith partner began taking a generic version of Paxil to treat anxiety and depression.
The complaint accuses GSK of failing to include a warning on Paxil’s labeling that the drug has ties to suicidal behavior in adults. At the time of Dolin’s death, according to the suit, Paxil’s labeling only referenced an association with suicide risk among people aged 24 and younger. Dolin’s lawyers, led by Baum Hedlund’s Brent Wisner, also lodged broader accusations that GSK knew about Paxil’s association with suicide in adults and deliberately concealed that information for decades.
The suit also initially made related claims against Mylan Inc., the drug company that manufactured the generic Paxil that Stewart Dolin actually took. Zagel, however, dismissed Mylan in 2014, finding the claims against the generic maker were preempted by federal drug labeling law.
GSK, defended by Atlanta-based King & Spalding partners Andrew Bayman and Todd Davis and Chicago-based lawyers from Dentons, has denied Dolin’s allegations. The company’s defense lawyers lodged a pair of summary judgment motions in late July, arguing that GSK should be cleared of any liability on multiple grounds.
One of those motions focused on a federal preemption argument. At the time of Stewart Dolin’s suicide, GSK’s lawyers wrote, the company hadn’t been required by the U.S. Food and Drug Administration to include warnings about suicide risks associated with Paxil for patients older than 24.
A separate GSK motion seeks to undermine other aspects of the suit, including allegations that Stewart Dolin’s doctor didn’t know about Paxil’s full suicide risks before prescribing it. The defense lawyers also reiterated that Dolin had taken a generic version of Paxil, made by Mylan, before the suicide.
“A plaintiff must establish that it was the defendant’s product that actually caused the alleged harm,” GSK’s legal team wrote in support of the summary judgment motion, which was made publicly available in October. “It remains undisputed that Mr. Dolin never ingested GSK’s product Paxil.”
Dolin’s contested both motions in court, but at a status hearing on Tuesday, Zagel put off his ultimate decision on the issues until sometime after the trial begins.
King & Spalding’s Davis referred a request for comment to GSK. In a statement, a company spokeswoman noted that the company’s summary judgment motions remain pending with the court and that Dolin had not been taking brand-name Paxil.
Baum Hedlund’s Wisner, who represents Dolin, said in an email on Wednesday that he’s encouraged that the judge declined to rule on GSK’s pretrial motions.
Opinions expressed by Forbes Contributors are their own.
The reputation of GlaxoSmithKline has suffered a number of hits in the past few years. In 2012, it paid $3 billion to the Department of Justice to settle charges that GSK paid doctors to prescribe drugs for unapproved uses. In 2014, GSK had to pay a fine of $488 million in China for bribing doctors to prescribe its drugs.
When a new product is launched, a company seeks to make its availability known. It will also seek to have experts in the field talk about the new drug to doctors who are most likely to prescribe it. These discussions focus on the value of the drug, the benefits it brings compared to existing therapies, how the drug should be best prescribed and, yes, even the side effects. Any company, large or small, will strive to find experts who are well known and are well respected among their peers to discuss its drug. If a company is fortunate to recruit such an expert, it will pay all of that expert’s expenses as well as an honorarium for her time and efforts.
Ah, there’s the rub–money! Because these experts get paid, there is an unfortunate perception on the part of some that these experts are really “hired guns” who are acting as shills for the evil drug company. GSK is trying to change this perception by no longer using such paid experts. Instead, GSK plans to hire people to perform this function so that it will be transparent to all that these are GSK employees touting its medicines.
By doing this, GSK feels it is taking the high road. In fact, a GSK executive claimed that the use of paid external experts will one day be viewed as the same as smoking on airplanes. “People will look back and say ,‘Did we really used to do that?’”
If true, that would be a shame. Using experts to tout a new drug benefits not just the company but patients and physicians. An expert puts his name and reputation on the line when discussing his or her experience with a new medicine. Such testimony can be very powerful. That’s why companies do this. An expert provides an imprimatur of the meaningfulness of the clinical data that supports the drug’s benefits. This can provide assurance to prescribers and, ultimately, patients that experts in the field believe this new medicine has value.
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But, of course, these experts are being PAID. How can they be trusted? Well, can we really expect experts to do this on a pro bono basis? I doubt that any of us would agree to take time to do this sort of work for free. Furthermore, all of these payments are now publicly disclosed. As a result of the Affordable Care Act (“Obamacare”), every payment in excess of $10 made to a physician by a drug company is now publicly reported. Thus, people have complete transparency as to the amount experts are being paid for their work.
One has to question what real value GSK’s new policy will create. If a newly hired GSK physician presents to a group of doctors about a new GSK drug, will he or she have more credibility than an outside expert? The GSK physician will undoubtedly have goals on the effectiveness of his or her work–essentially, greater drug sales. Yet, it is difficult to believe a GSK employee will generate more credibility than an external expert who has little stake in the ultimate commercial success of the new drug. If I were a physician or a patient, I would be more comforted knowing some of the leading lights in the field have used and endorsed the new drug as opposed to a GSK employee.
The biopharmaceutical industry certainly needs to improve its reputation. GSK, in particular, faces challenges and I am sure it believes that it is doing the right thing with this shift in policy. However, I think this move is a disservice to the those who are diligent about learning the pros and cons of new drugs. Hopefully, the rest of the biopharmaceutical industry will not follow GSK’s lead on this topic.
A former GlaxoSmithKline biostatistics manager has filed a whistleblower lawsuit accusing the drug maker of firing him for alleging dodgy study data was used to tout the effectiveness of a smoking-cessation product.
Alexandre Selmani, who worked at Glaxo for nearly a decade, claims his supervisors ignored repeated efforts to alert them to statistical mistakes made in clinical trials for NiQuitin, according to the lawsuit, which was filed in a New Jersey state court. In the United States, Glaxo markets the product as Nicoderm.
As a result, he claims the company engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment. The lawsuit also alleges Glaxo maintained its product was superior to existing nicotine treatments.
Selmani began complaining about the data in mid-2012. But after meeting resistance, he claims to have sent an email to Glaxo Chief Executive Andrew Witty to warn that the mistakes had “the capacity to cause negative consequences and potential health and safety issues for the general public,” the lawsuit argues, although it does not allege any consumers were harmed.
Along with the drug maker, the lawsuit also names Witty and several employees as defendants. A Glaxo spokeswoman declined to comment.
Despite his protests, the company submitted the data for publication and the study was eventually published online in Psychopharmacology in April 2014. The study abstract concluded the product “could be useful to provide quick craving relief for low-dependence smokers.”
In his suit, Selmani maintains that his supervisors retaliated against him by giving him low job performance ratings and reduced raises; sabotaging some of his work; and, ultimately, firing him last October. His lawsuit cites the New Jersey Conscientious Employee Protection Act, which addresses retaliation by employers.
“The company wanted to use flawed data to sell the product to the public,” Rosemarie Arnold, his attorney, told us. “And when he brought that to the attention of his supervisor, he was basically told to shut up. He worked there many years, got great reviews, and did a great job. But they tried to push him out when he complained they used improper data. And consumers paid for something they didn’t get.”
According to the lawsuit, Selmani’s supervisor told him that he was wasting his time to report the mistakes because he would never be able to convince management to fix them. At one point, Selmani was also told that his “future was not with GSK.”