(Credit: Getty Images/Oliver Lang)
WikiLeaks has brought to light a series of disturbing insinuations and startling truths in the last year, some earth-shattering, others simply confirmations of our darkest suspicions about the way the world works. Thanks to founder Julian Assange's legal situation in Sweden (and potentially the United States) as well as his media grandstanding, it is easy to forget how important and interesting some of WikiLeaks' revelations have been.
WikiLeaks revelations from 2010 have included simple gossip about world leaders: Russia's PM Vladimir Putin is playing Batman to President Dmitri Medvedev's Robin; Iranian President Mahmoud Ahmadinejad is crazy and was once slapped by a Revolutionary Guard chief for being so; Libya's Col. Muammar el-Qaddafi has a hankering for his voluptuous blond Ukrainian nurse; and France's President Nicholas Sarkozy simply can't take criticism.
CBS News Special Report: WikiLeaks
However, WikiLeaks' revelations also have many major implications for world relations. The following is a list of the more impactful WikiLeaks revelations from 2010, grouped by region.
The United States
- The U.S. Army considered WikiLeaks a national security threat as early as 2008, according to documents obtained and posted by WikiLeaks in March, 2010.
- Then-Secretary of Defense Donald Rumsfeld and his top commanders repeatedly, knowingly lied to the American public about rising sectarian violence in Iraq beginning in 2006, according to the cross-referencing of WikiLeaks' leaked Iraq war documents and former Washington Post Baghdad Bureau Chief Ellen Knickmeyer's recollections.
- The Secretary of State's office encouraged U.S. diplomats at the United Nations to spy on their counterparts, including collecting data about the U.N. secretary general, his team and foreign diplomats, including credit card account numbers, according to documents from WikiLeaks U.S. diplomatic cable release. Later cables reveal the CIA draws up an annual "wish-list" for the State Department, which one year included the instructions to spy on the U.N.
- The Obama administration worked with Republicans during his first few months in office to protect Bush administration officials facing a criminal investigation overseas for their involvement in establishing policies that some considered torture. A "confidential" April 17, 2009, cable sent from the US embassy in Madrid obtained by WikiLeaks details how the Obama administration, working with Republicans, leaned on Spain to derail this potential prosecution.
- WikiLeaks released a secret State Department cable that provided a list of sites around the world vital to U.S. national security, from mines in Africa to labs in Europe.
Iraq
- A U.S. Army helicopter allegedly gunned down two journalists in Baghdad in 2007. WikiLeaks posted a 40-minute video on its website in April, showing the attack in gruesome detail, along with an audio recording of the pilots during the attack.
- Iran's military intervened aggressively in support of Shiite combatants in Iraq, offering weapons, training and sanctuary, according to an October, 2010, WikiLeaks release of thousands of secret documents related to the Iraq war.
- According to one tabulation, there have been 100,000 causalities, mostly civilian, in Iraq - greater than the numbers previously made public, many of them killed by American troops but most of them were killed by other Iraqis, according to the WikiLeaks Iraq documents dump.
- U.S. authorities failed to investigate hundreds of reports of abuse, torture, rape and even murder by Iraqi police and soldiers whose conduct appears to be systematic and normally unpunished, according to the WikiLeaks Iraq documents dump.Afghanistan
- U.S. special-operations forces have targeted militants without trial in secret assassination missions, and many more Afghan civilians have been killed by accident than previously reported, according to the WikiLeaks Afghanistan war document dump.
- Afghan President Hamid Karzai freed suspected drug dealers because of their political connections, according to a secret diplomatic cable. The cable, which supports the multiple allegations of corruption within the Karzai government, said that despite repeated rebukes from U.S. officials in Kabul, the president and his attorney general authorized the release of detainees. Previous cables accused Karzai's half-brother, Ahmed Wali Karzai, of being a corrupt narcotics trafficker.
Asia
- Pakistan's government has allowed members of its spy network to hold strategy sessions on combating American troops with members of the Taliban, while Pakistan has received more than $1 billion a year in aid from Washington to help combat militants, according to a July, 2010, WikiLeaks release of thousands of files on the Afghanistan war.
- A stash of highly enriched uranium capable of providing enough material for multiple "dirty bombs" has been waiting in Pakistan for removal by an American team for more than three years but has been held up by the country's government, according to leaked classified State Department documents.
- Despite sustained denials by US officials spanning more than a year, U.S.military Special Operations Forces have been conducting offensive operations inside Pakistan, helping direct U.S. drone strikes and conducting joint operations with Pakistani forces against Al Qaeda and Taliban forces in north and south Waziristan and elsewhere in the Federally Administered Tribal Areas, according to secret cables released as part of the Wikileaks document dump.
- China was behind the online attack of Google, according to leaked diplomatic cables. The electronic intrusion was "part of a coordinated campaign of computer sabotage carried out by government operatives, private security experts and internet outlaws recruited by the Chinese government."
- Secret State Department cables show a South Korean official quoted as saying that North Korea's collapse is likely to happen "two to three years" after the death of the current dictator, Kim Jong Il. The U.S. is already planning for the day North Korea implodes from its own economic woes. China has "no will" to use its economic leverage to force North Korea to change its policies and the Chinese official who is the lead negotiator with North Korea is "the most incompetent official in China."
- North Korea is secretly helping the military dictatorship in Myanmar build nuclear and missile sites in its jungles, according to a leaked diplomatic cable. Although witnesses told the embassy that construction is at an early stage, officials worry Myanmar could one day possess a nuclear bomb.
- Five years ago, the International Committee of the Red Cross told U.S. diplomats in New Delhi that the Indian government "condones torture" and systematically abused detainees in the disputed region of Kashmir. The Red Cross told the officials that hundreds of detainees were subjected to beatings, electrocutions and acts of sexual humiliation, the Guardian newspaper of London reported Thursday evening.
- The British government has been training a Bangladeshi paramilitary force condemned by human rights organisations as a "government death squad", leaked US embassy cables have revealed. Members of the Rapid Action Battalion (RAB), which has been held responsible for hundreds of extra-judicial killings in recent years and is said to routinely use torture, have received British training in "investigative interviewing techniques" and "rules of engagement".
- Secret U.S. diplomatic cables reveal that BP suffered a blowout after a gas leak in the Caucasus country of Azerbaijan in September 2008, a year and a half before another BP blowout killed 11 workers and started a leak that gushed millions of gallons of oil into the Gulf of Mexico.
Middle East
- Saudi Arabia's rulers have deep distrust for some fellow Muslim countries, especially Pakistan and Iran, despite public appearances, according to documents from the late November, 2010, WikiLeaks U.S. diplomatic cable dump. King Abdullah called Pakistan's president Asif Ali Zardari "the greatest obstacle" to the country's progress and he also repeatedly urged the United States to attack Iran to destroy its nuclear program to stop Tehran from developing a nuclear weapon.
- Iranian Red Crescent ambulances were used to smuggle weapons to Lebanon's militant Hezbollah group during its 2006 war with Israel, according to the leaked U.S. diplomatic memos.
- In a leaked diplomatic memo, dated two weeks after elections that landed Israeli Prime Minister Benjamin Netanyahu in office, a senior American diplomat said that during a meeting a few days before "Netanyahu expressed support for the concept of land swaps, and emphasized that he did not want to govern the West Bank and Gaza but rather to stop attacks from being launched from there."
- The United States was secretly given permission from Yemen's president to attack the al Qaeda group in his country that later attempted to blow up planes in American air space. President Ali Abdullah Saleh told John Brennan, President Obama's counterterrorism adviser, in a leaked diplomatic cable from September 2009 that the U.S. had an "open door" on terrorism in Yemen.
- Contrary to public statements, the Obama administration actually helped fuel conflict in Yemen. The U.S. was shipping arms to Saudi Arabia for use in northern Yemen even as it denied any role in the conflict.
- Saudi Arabia is one of the largest origin points for funds supporting international terrorism, according to a leaked diplomatic cable. Secretary of State Hillary Clinton urged U.S. diplomats to do more to stop the flow of money to Islamist militant groups from donors in Saudi Arabia. The Saudi government, Clinton wrote, was reluctant to cut off money being sent to the Taliban in Afghanistan and Lashkar-e-Taiba (LeT) in Pakistan.
- The U.S. is failing to stop the flow of arms to Middle Eastern militant groups. Hamas and Hezbollah are still receiving weapons from Iran, North Korea, and Syria, secret diplomatic cables allege.
- A storage facility housing Yemen's radioactive material was unsecured for up to a week after its lone guard was removed and its surveillance camera was broken, a secret U.S. State Department cable released by WikiLeaks revealed Monday. "Very little now stands between the bad guys and Yemen's nuclear material," a Yemeni official said on January 9 in the cable.
- Israel destroyed a Syrian nuclear reactor in 2007, constructed with apparent help from North Korea, fearing it was built to make a bomb. In a leaked diplomatic cable obtained by the Israeli daily Yedioth Ahronoth, then-US secretary of state Condoleezza Rice wrote the Israelis targeted and destroyed the Syrian nuclear reactor just weeks before it was to be operational.
- Diplomatic cables recently released by WikiLeaks indicate authorities in the United Arab Emirates debated whether to keep quiet about the high-profile killing of a Hamas operative in Dubai in January. The documents also show the UAE sought U.S. help in tracking down details of credit cards Dubai police believe were used by a foreign hit squad involved in the killing. The spy novel-like slaying, complete with faked passports and assassins in disguise, is widely believed to be the work of Israeli secret agents.
- WikiLeaks founder Julian Assange told Al Jazeera network that some of the unpublished cables show "Top officials in several Arab countries have close links with the CIA, and many officials keep visiting US embassies in their respective countries voluntarily to establish links with this key US intelligence agency. These officials are spies for the U.S. in their countries."
Europe
- Of the 500 or so tactical nuclear weapons in the U.S. arsenal, it is known that about 200 are deployed throughout Europe. Leaked diplomatic cables reveal that dozens of U.S. tactical nuclear weapons are in Germany, the Netherlands and Belgium.
- NATO had secret plans to defend the Baltic states and Poland from an attack by Russia, according to a leaked diplomatic cable. NATO officials had feared "an unnecessary increase in NATO-Russia tensions," and wanted no public discussions of their contingency plans to defend Baltic states from Russian attack.
- The Libyan government promised "enormous repercussions" for the U.K. if the release of Abdel Baset al-Megrahi, the Lockerbie bomber, was not handled properly, according to a leaked diplomatic cable. The Libyan government threatened "harsh, immediate" consequences if the man jailed for the bombing of Pan Am Flight 103 died in prison in Scotland.
- Pope Benedict impeded an investigation into alleged child sex abuse within the Catholic Church, according to a leaked diplomatic cable. Not only did Pope Benedict refuse to allow Vatican officials to testify in an investigation by an Irish commission into alleged child sex abuse by priests, he was also reportedly furious when Vatican officials were called upon in Rome.
- Sinn Fein leaders Gerry Adams and Martin McGuinness carried out negotiations for the Good Friday agreement with Irish then-prime minister Bertie Ahern while the two had explicit knowledge of a bank robbery that the Irish Republican Army was planning to carry out, according to a WikiLeaks cable. Ahern figured Adams and McGuinness knew about the 26.5 million pound Northern Bank robbery of 2004 because they were members of the "IRA military command."
Africa
- Anglo-Dutch oil giant Royal Dutch Shell PLC has infiltrated the highest levels of government in Nigeria. A high-ranking executive for the international Shell oil company once bragged to U.S. diplomats, as reported in a leaked diplomatic cable, that the company's employees had so well infiltrated the Nigerian government that officials had "forgotten" the level of the company's access.
- Mozambique is fast on its way to becoming a narco-state because of close ties between drug smugglers and the southeastern African nation's government, according to U.S. Embassy cables released by WikiLeaks. The cables say cocaine, heroin and other drugs come in from South America and Asia, and are then flown to Europe or sent overland to neighboring South Africa for sale.
- Zimbabwe's Robert Mugabe-appointed attorney general announced he was investigating Mugabe's chief opposition leader on treason charges based exclusively on the contents of a WikiLeaks' leaked cable. The cable claimed Zimbabwe opposition leader Morgan Tsvangirai encouraged Western sanctions against his own country to induce Mugabe into giving up some political power.
Americas/Caribbean
- Mexican President Felipe Calderon told a U.S. official last year that Latin America "needs a visible U.S. presence" to counter Venezuelan President Hugo Chavez's growing influence in the region, according to a U.S. State Department cable leaked to WikiLeaks.
- A newly released confidential U.S. diplomatic cable predicts Cuba's economic situation could become "fatal" within two to three years, and details concerns voiced by diplomats from other countries, including China, that the communist-run country has been slow to adopt reforms.
- The Honduran military, Supreme Court and National Congress conspired in 2009 in what constituted an illegal and unconstitutional coup against the Executive Branch, according to a leaked diplomatic cable. However, the constitution itself may be deficient in terms of providing clear procedures for dealing with alleged illegal acts by the President and resolving conflicts between the branches of government.
- Venezuela's deteriorating oil industry and its growing economic problems are taking a toll on President Hugo Chavez's popularity. In one confidential leaked diplomatic cable dated Oct. 15, 2009, the U.S. Embassy said "equipment conditions have deteriorated drastically" since the government expropriated some 80 oil service companies earlier that year. It said safety and maintenance at the now state-owned oil facilities were in a "terrible state."
- China has been reselling Venezuela's cheap oil at a profit, according to a classified U.S. document released by WikiLeaks. President Hugo Chavez was upset that China apparently profited by selling fuel to other countries, fuel that it had sold China at a discount in order to gain favor. The cable also describes falling crude output in Venezuela caused by a host of problems within the national oil company Petroleos de Venezuela SA, or PDVSA.
- Jamaica's counter-drug efforts have been so sluggish that exasperated Cuban officials privately griped about their frustrations to a U.S. drug enforcement official, according to a U.S. diplomatic cable. The communique released by WikiLeaks said Cuban officials painted their Caribbean neighbor to the south as chronically uncooperative in stopping drug smugglers who use Cuban waters and airspace to transport narcotics destined for the U.S.
- A leaked U.S. diplomatic cable published Saturday depicts the leader of Mexico's army "lamenting" its lengthy role in the anti-drug offensive, but expecting it to last between seven and 10 more years. The cable says Mexican Defense Secretary Gen. Guillermo Galvan Galvan mistrusts other Mexican law enforcement agencies and prefers to work separately, because corrupt officials had leaked information in the past.
- McDonald's tried to delay the US government's implementation of a free-trade agreement in order to put pressure on El Salvador to appoint neutral judges in a $24m lawsuit it was fighting in the country. The revelation of the McDonald's strategy to ensure a fair hearing for a long-running legal battle against a former franchisee comes from a leaked US embassy cable dated 15 February 2006.
In 2010, WikiLeaks released only about 2,000 of the approximate 250,000 cables it claims to possess, and the pace of those releases dropped dramatically as the holidays approached. If Assange's promises are to be believed, 2011 will be another important year for learning about the hidden forces that drive our world.
Friday, December 31, 2010
How WikiLeaks Enlightened Us in 2010 - CBS News
Pfizer Must Pay $1.5 Million in Prempro Damages, Jury in Puerto Rico Says - Bloomberg
Pfizer Inc. must pay $1.5 million in damages to a woman who developed breast cancer after taking one of the company’s menopause drugs, a jury in Puerto Rico ruled.
Jurors in federal court in San Juan deliberated about 7 hours over two days before finding yesterday that Pfizer’s Wyeth subsidiary failed to properly warn Helen Rivera-Adams and her doctors about the health risks of its Prempro menopause medicine, one of her lawyers said in an interview.
Rivera-Adams, suffering from the late stages of cancer, pushed ahead with the trial “to get the message out that this drug is dangerous,” Michael Robb, one of her lawyers, said in a telephone interview today. “I don’t know how many times Wyeth executives will have to hear that this drug ruins women’s lives before they acknowledge it.”
J&J Directors Ignored ‘Red Flags’ on Recalls, Probes, Suit Says - BusinessWeek
A group of Johnson & Johnson shareholders accused the company’s directors of ignoring “red flags” foreshadowing product recalls and government probes of manufacturing defects and marketing practices.
The shareholders asked a judge to find that directors and top executives mismanaged J&J and order them to pay damages. They also want J&J to “improve its corporate governance and internal procedures,” according to a complaint filed Dec. 17 in federal court in Trenton, New Jersey. Any money recovered would go to the company and not investors.
New Drug Approvals Fall in 2010 - Bloomberg
Twenty-one new drugs were approved in the U.S. this year, the fewest since 2007, as the Food and Drug Administration showed more willingness to delay or reject medicines with potential safety risks.
The tally, compiled by Bloomberg from an FDA database, compares with 25 approvals last year and 24 in 2008, according to the FDA’s website. Nineteen new drugs were cleared in 2007, the fewest in 24 years.
Which Pharma CEO said this
Answer
Maybe a change of CEO is what's needed!
Thursday, December 30, 2010
BBC News - ProStrakan testosterone drug Fortesta wins US approval
A testosterone gel developed by Scottish pharmaceutical firm ProStrakan has won approval in America.
Galashiels-based ProStrakan has teamed up with the US firm Endo Pharmaceuticals to sell Fortesta in the States.
Fortesta is used to treat men with low levels of testosterone, which is linked to osteoporosis and low libido.
The drug is already sold in the UK and Europe and it is estimated that US deal could be worth £60m annually.
The approval by the US food and drug administration has already triggered a payment of around £8m to ProStrakan from Endo.
Further "milestone" payments could take the total much higher if sales targets are achieved in America.
Meanwhile, ProStrakan said that it was still evaluating a number of offers for the company.
Last month the Borders firm rejected a bid from the Dutch group Norgine.
Allergy Notes: Former Olympian and coach died of antihistamine overdose
Antonio Pettigrew, who was stripped of an Olympic gold medal for using performance-enhancing drugs, died of an overdose of an antihistamine used in sleeping aids, according to an autopsy report. The medical examiner ruled the death a suicide.
The autopsy report states that he died of a "lethal concentration of diphenhydramine" (the same medication found in Benadryl). The investigators found an empty bottle of Unisom, a sleeping aid in which diphenhydramine is an ingredient, in victim's car.
Pettigrew was part of the 4x400-meter relay team that won gold at the 2000 Summer Olympics in Sydney, Australia. Two years ago, the International Olympic Committee stripped him and other team members of their medals after he testified in federal court that he took human growth hormone and EPO, which boosts oxygen, between 1997 and 2001.
Which doctors are Big Pharma paying? - Press-Telegram
Come 2013, drug companies in the $200 billion-plus pharmaceutical industry must start publicly disclosing gifts and payments to physicians.
That's a requirement of one of the most pro-consumer provisions of the federal health-care legislation signed by President Barack Obama earlier this year.
Drug companies spend $30 billion annually on marketing, much of it directly aimed at physicians.
Patients have a right to know whether their physicians accept those payments - not all do - and how much they get.
A preview of that information has been appearing at the investigative journalism website ProPublica.org. It's worth a visit for any consumer of medical services. The database is readily searchable by physician name, by city and more.
The New York-based ProPublica has identified 43 physicians who have earned more than $200,000 since 2009 in speaking and consulting fees from drug and medical device companies that are disclosing payments.
Three Californians are in the $200,000-plus club. Another 36 California doctors received payments of between $100,000 and $200,000. Scores of others have collected thousands or tens of thousands in payments.
The disclosures represent a fraction of drug company payments made to physicians. Only seven of the 70 pharmaceutical companies operating in the United States are making their payments public.
Wednesday, December 29, 2010
Open letter to prime minister David Cameron and health secretary Andrew Lansley -- Nicholl et al. 341 -
Open letter to prime minister David Cameron and health secretary Andrew Lansley
- David J Nicholl, consultant neurologist, City Hospital, Birmingham,
- David Hilton-Jones, consultant neurologist, John Radcliffe Infirmary, Oxford,
- Jacqueline Palace,, consultant neurologist, John Radcliffe Infirmary,
- Sam Richmond, consultant paediatrician, Sunderland Royal Hospital, Sunderland,
- Sarah Finlayson, congenital myasthenia clinical fellow, John Radcliffe Infirmary,
- John Winer, consultant neurologist, University Hospital Birmingham,
- Andrew Weir, consultant neurologist, Royal Berkshire NHS Trust, Reading,
- Paul Maddison, consultant neurologist, Nottingham University Hospitals NHS Trust, Nottingham,
- Nick Fletcher, consultant neurologist, Walton Centre for Neurology & Neurosurgery, Liverpool,
- Jon Sussman, consultant neurologist, Greater Manchester Neuroscience Centre, Hope Hospital, Salford,
- Nick Silver, consultant neurologist, Walton Centre for Neurology & Neurosurgery,
- John Nixon, consultant neurologist, Royal Preston Hospital, Preston,
- Dimitri Kullmann, consultant neurologist, Institute of Neurology, London,
- Nick Embleton, consultant paediatrician, Royal Victoria Infirmary, Newcastle upon Tyne,
- David Beeson, professor in neuroscience, Weatherall Institute of Molecular Medicine, Oxford,
- Maria Elena Farrugia, consultant neurologist, Institute of Neurological Sciences, Southern General Hospital, Glasgow,
- Marguerite Hill, consultant neurologist and senior clinical tutor, Abertawe Bro Morgannwg University Local Health Board, Swansea,
- Chris McDermott, consultant neurologist, Royal Hallamshire Hospital, Sheffield,
- Gareth Llewelyn, consultant neurologist, Royal Gwent Hospital, Newport,
- James Leonard, professor emeritus, Institute of Child Health, University College London,
- Michael Morris, chairman of the Myasthenia Gravis Association, Derby
- Correspondence to: D J Nicholl david.nicholl@nhs.net
Neurologists and paediatricians call for action on “massive” rises in the prices of orphan drugs
We are writing to you as a group of clinicians treating patients with so called “orphan” diseases (and one representative of a patients’ group) to express our concern at an unintended effect of the European Union’s regulations on orphan drugs. The original purpose of this legislation, passed in 1999, was to encourage drug companies to conduct research into rare diseases and develop novel treatments. However, as the rules are currently enacted, many drug companies merely address their efforts to licensing drugs that are already available rather than developing new treatments. Once a company has obtained a licence, the legislation then gives the company sole rights to supply the drug. This in turn allows the company to set an exorbitant price for this supply and effectively to bar previous suppliers of the unlicensed preparation from further production and distribution.
We believe that this behaviour is not in the best interests of patients or the NHS but is undoubtedly significantly advantageous to drug companies. We have made representations to the Department of Health for England and the UK Medicines and Healthcare Products Regulatory Agency. In reply we have simply been quoted the rules, and no one seems willing to investigate the issues we are raising or to consider whether the system should be changed. We are asking you to identify the appropriate individuals who can act on this unacceptable situation.
One example of the effect of these rules is the drug 3,4-diaminopyridine (3,4-DAP). We have been using 3,4-DAP for more than 20 years to treat two rare diseases, Lambert-Eaton myasthenic syndrome and congenital myasthenic syndrome; both cause disabling muscle weakness of the limbs, body, eyes, and face, together with swallowing and breathing problems, which can be fatal. The drug improves muscle strength and is used either because other treatments haven’t worked well enough or to avoid using drugs that can have serious side effects. Expert clinicians take the responsibility for informing patients about the drug and prescribing it. It has an excellent safety record. Until now 3,4-DAP has been produced by a small drug company on an unlicensed basis and costs between £800 (€945; $1285) and £1000 per patient per year.
The company BioMarin has now been issued with a licence to supply the drug (marketed as Firdapse) throughout Europe and has priced its product at £40 000 to £70 000 per patient per year—a 50-fold to 70-fold increase. BioMarin merely had to demonstrate that its drug works, using data generated from the unlicensed version. It has simply produced a slightly modified version (amifampridine) that meets regulatory standards and has been allowed to set the price at an exorbitant level with no clinically relevant advantage.
This high cost means firstly that some funders (primary care trusts) have refused to pay for the drug, because it doesn’t fulfil cost effectiveness criteria. It also means that, where it is funded, no additional funding source has been identified, which must mean that patients in other areas are being deprived of NHS funding. The cost to the NHS is likely to be above £10m a year.
We urge you to instruct urgent review not only for the sake of our particular patients but also for the many other patients who are likely to be affected in the near future as other drug companies take advantage of this loophole. Extraordinarily, there is a website that lists other drugs that can be similarly exploited (www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm216147.htm).
In the present economic situation it seems vital to ensure that systems are in place to prevent excessive commercial profits being made at the expense of patients and public spending. Although the pricing of 3,4-DAP is the most recent example of this trend,1 massive price rises have been noted in treatments for other orphan diseases for years; examples include N-carbamylglutamate (for N-acetylglutamate synthetase deficiency), sodium phenylbutyrate (for ornithine carbomoyltransferase deficiency), ibuprofen and indometacin (for patent ductus arteriosus), caffeine citrate (for apnoea in preterm infants), and even nitric oxide (for pulmonary hypertension).2 3
We believe there to be sufficient grounds for the UK parliamentary health select committee to look at the pricing of orphan drugs, as the costs directly affect patients of all ages with a diverse range of conditions across the country. If an investigation were to find evidence of artificially high pricing, the Office of Fair Trading should consider pursuing the issue.
Legislation on orphan drugs, far from encouraging the development of new treatments for orphan diseases, is severely limiting the availability of existing treatments. We believe that the Medicines and Healthcare Products Regulatory Agency and Department of Health should not just state the rules but should act now to progress the issue of unfairness upwards, so as to instigate change.
Footnotes
Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare no support from any organisation for the submitted work; JL has acted as a consultant to orphan drug manufacturers (Special Products Ltd and Swedish Orphan), has been paid travel expenses to attend professional meetings on orphan drugs, was on an educational advisory panel for the Orphan Academy, supported by Orphan Europe, and has chaired workshops for Swedish Orphan; and no other relationships or activities that could appear to have influenced the submitted work.
See Editorial, doi: 10.1136/bmj.c6456; Feature, doi:10.1136/bmj.c6459; Analysis, doi:10.1136/bmj.c6471.
References
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Martin, D. Hospitals are forced to use unlicensed drugs to save millions. Daily Mail 27 Sep 2010. www.dailymail.co.uk/health/article-1315441/Hospitals-forced-use-unlicensed-medicines-save-millions.html.
- ↵
Boseley S. EU loophole sends drug prices soaring. Guardian 24 Jun 2002. www.guardian.co.uk/society/2002/jun/24/health.medicineandhealth1.
- ↵
Leonard JV, Richmond S. Pricing of orphan drugs. Lancet2009;373:462.
Tuesday, December 28, 2010
Savient searching for a CEO
Martha Rosenberg | The Year in Pills
Martha Rosenberg | The Year in Pills
Published on Dec 27, 2010 - 7:35:40 AMBy: Martha Rosenberg
December 27, 2010 - 2010 will go down as the year the diet pill Meridia and pain pill Darvon were withdrawn from the market and the heart-attack associated diabetes drug Avandia was severely restricted.
But it was also the year the Justice Department filed the first criminal, not civil, charges against a drug company executive, former GSK VP and assistant general counsel Lauren Stevens.
And the year prominent psychiatrists Charles Nemeroff and Alan Schatzberg were accused of writing an entire book to teach primary care physicians p$ychopharmacology.
Still most of the action was promotion of dangerous pills, many of which should never have been approved.
Here is 2010's Hall of Shame.
Yaz and Yasmin
Soon after Bayer launched the pill Yaz in 2006, billing it as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. FDA ordered Bayer to run correction ads that detail the drugs' risks though Yaz sales are still brisk. In fact, financial analysts attribute a third quarter slump to a Yaz generic coming online, not dangerous side effects.
Lyrica, Topamax and Lamictal
In August FDA ordered a warning on the seizure drug Lamictal for aseptic meningitis (brain inflammation) but it is still the darling of military and civilian doctors for unapproved pain and migraine uses. All three drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels, in addition to the memory and hair loss patients report.Humira, Prolia and TNF Blockers
The drug industry's highly promoted biologic drugs are made from genetically engineered hamster cells and suppress the immune system, inviting tuberculosis and several cancers. Yet Humira is advertised to healthy people for "clearer skin" and Prolia is advertised to prevent osteoporosis in healthy women.Chantix
After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal behaviors and 28 actual suicides, the government banned pilots, air-traffic controllers and interstate truck and bus drivers from taking the antismoking drug Chantix in 2008. Its neuropsychiatric effects were immortalized when New Bohemians musician Carter Albrecht was shot to death in 2007 in Texas by a neighbor after acting aggressively on the Chantix.
Ambien
The sleeping pill Ambien was immortalized as the drug Tiger Woods reportedly cavorted with his consorts on and former US Rep. Patrick Kennedy crashed his Ford Mustang on, while driving to Capitol Hill in the middle of the night to "vote" in 2006. Law enforcement officials say it has increased traffic accidents from people who drive in a black out and don't even recognize arresting officers.
Tamoxifen
Is it a coincidence that Tamoxifen maker AstraZeneca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? As a breast cancer prevention drug, an American Journal of Medicine study found the average life expectancy increase from Tamoxifen was nine day . Public Citizen says for every case of breast cancer prevented on Tamoxifen there is a life-threatening case of blood clots, stroke or endometrial cancer.Lipitor and Crestor
Why is Lipitor the best selling drug in the world? Because every adult with high LDL or fear of high LDL is on it. And also 2.8 million children, says Consumer Reports. All statins can cause muscle breakdown called rhabdomyolysis. And Crestor is so linked to the side effect, Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before at a Congressional hearing.Boniva
Boniva and other bisphosphonate bone drugs are a good example of FDA approving once unapprovable drugs by transferring risk onto the public's shoulders. The list of dangers on the label includes waiting 60 minutes before eating or drinking anything except plain water, never taking the drug with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins and not lying down after you take it.Prempro
Pfizer's hormone drug Prempro is linked to a 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease and double the rate of blood clots. But its cognitive and cardiovascular "benefits" are being tested right now at major universities to debut an HT "Light," hoping the public has a short memory.
Prozac, Paxil, Zoloft, SSRIs
Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate drug industry profits than Viagra. But many say the drugs have also inflated police blotters. In addition to 4,200 published reports of SSRI-related violence, including the Columbine, Red Lake and NIU shootings, SSRIs can cause serotonin syndrome and gastrointestinal bleeding when taken with certain drugs. Paxil is linked to birth defects.Effexor, Cymbalta, Pristiq, SNRIs
Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. SNRI's are also harder to quit than SSRIs. 739,000 web sites address "Effexor" and "withdrawal."Seroquel, Zyprexa, Geodon, atypical antipsychotics
The antipsychotic Seroquel tops 71 drugs on the FDA's January 2010 adverse event report and is linked to unexplained troop deaths and many research scandals. But it's the fifth biggest-selling drug in the world. Atypical antipsychotics cause weight gain and diabetes, the tardive dyskinesia they are marketed to prevent and death in the demented elderly. Yet FDA approved Zyprexa and Seroquel for children last year and the new atypical antipsychotic, Latuda this year. Maybe the FDA is bipolar.Ritalin, Concerta, Strattera, Adderall and ADHD drugs
ADHD drugs rob "kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors," says Anatomy of an Epidemic author Robert Whitaker. But they are a gold mine for the drug industry. During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola lauded the "very dynamic ADHD market," and the "co-administration market" (in which kids don't need one drug but several.Gardasil and Cervarix vaccines
A pharma-government plot to inoculate the public with dangerous vaccines? Maybe not but why are governors like Texas' Rick Perry mandating vaccination of girls for HPV? And why was University of Queensland lecturer Andrew Gunn silenced when he questioned the Gardasil vaccine? The HPV vaccine doesn't work for all viral strains, requires a boo$ter and is linked to 56 US girls' deaths as of September, according to the CDC.Foradil Aerolizer, Serevent Diskus, Advair and Symbicort
Unlike drugs that look safe in trials and develop "safety signals" postmarketing, the long-acting beta agonists (LABA), salmeterol and formoterol, found in many asthma drugs, never looked safe. Studies link them to an increase in asthma deaths, especially in African-Americans and children. They may have contributed to 5,000 deaths said Dr. David Graham at FDA hearings about the controversial asthma drugs.Singulair and Accolate, leukotriene receptor antagonists
Leukotriene receptor antagonists also never looked safe. Original FDA reviewers said asthma control "deteriorates" on Singulair and it may not be safe in children. Last month, Fox TV reported Singulair, Merck's top selling drug, is suspected of producing aggression, hostility, irritability, anxiety, hallucinations and night-terrors in kids, symptoms that are being diagnosed as ADHD. It is huckstered to parents by the trusted educational service Scholastic, Inc. and the American Academy of Pediatrics.
Martha Rosenberg's work has appeared in the Chicago Tribune, L.A. Times, San Francisco Chronicle, Boston Globe, Providence Journal. Arizona Republic, New Orleans Times-Picayune and other newspapers. Now she also shares her views with YubaNet.com's readers.
In the interest of fostering civil and issue-oriented discourse, YubaNet does not publish reader comments identified by anonymous Internet "handles" (fake user ID names like "farfromthinkin"). Your full and real name will be published with your comment. Your email address will not be shown, unless you specifically "uncheck" the box 'Hide my email.' By submitting a comment you consent to our rules.
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Pharmaceutical Industry Fraud - The Nader Page
The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see Citizen.Org).
Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.
Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.
Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.
J&J, AstraZeneca Halt Pain Drug Tests on Bone-Damage Concerns - BusinessWeek
Dec. 28 (Bloomberg) -- Johnson & Johnson and AstraZeneca Plc stopped studies of experimental painkillers over concerns that a class of drugs once expected to generate as much as $11 billion in annual sales may raise the risk of joint damage.
The U.S. Food and Drug Administration notified J&J last week that the development program for the drug fulranumab had been put on hold, Jeffrey Leebaw, a spokesman for New Brunswick, New Jersey-based J&J, said in an e-mail. London-based AstraZeneca said yesterday it has voluntarily stopped early- stage research of a similar medicine. Regeneron Pharmaceuticals Inc. of Tarrytown, New York, said yesterday the FDA had halted trials of the company’s treatment in the class known as anti- nerve growth factors.
Pfizer Inc., the world’s largest drugmaker, suspended trials of the pain drug tanezumab in June after reports that patients in one of its studies needed joint replacements. The move left nerve-growth inhibitors a “tainted class” and has lowered investor expectations, said Ziad Bakri, a Cowen & Co. analyst in New York.
“You’d have to have a lot of safety data to ever get a drug like this approved, so for investors this is not a class that’s generating very high hopes,” Bakri said in a telephone interview. “You’re not going to see many companies chasing these drugs at this point.”
Monday, December 27, 2010
Things go better with Merck Coke
Guitarist and songwriter extraordinaire Keith Richards should have died a long time ago. He was a heroin addict for many years, which earned him the number one spot for ten years on New Musical Express’ list of rock stars most likely to die. He was also an aficionado of Merck cocaine—the pharmaceutical kind, a pure luxury compared to the street powder. In his autobiography Life, Richards confesses that the Rolling Stones’ 1975 tour was “fueled by Merck cocaine. It was when we initiated the building of hideaways behind the speakers on the stage so that we could have lines between songs.”
As Richards lets his supplier describe it (because the rocker’s memory is dim in that passage):
“Pharmaceutical cocaine cannot be compared in any way to cocaine produced in Central or South America. It is pure, does not bring on depression or lethargy. A totally different type of euphoria, one of creativity, exists immediately when it is absorbed by the central nervous system. There are absolutely no withdrawal symptoms.”
Funny, another celebrity rhapsodized very much the same way about pharmaceutical cocaine; no, not Eric Clapton. He worked in another industry, and in much earlier times. In 1884, Sigmund Freud wrote Uber Coca. This is what he said:
“…exhilaration and lasting euphoria, which in no way differs from the normal euphoria of the healthy person…You perceive an increase of self-control and possess more vitality and capacity for work….In other words, you are simply normal, and it is soon hard to believe you are under the influence of any drug….Long intensive physical work is performed without any fatigue…This result is enjoyed without any of the unpleasant after-effects that follow exhilaration brought about by alcohol….Absolutely no craving for the further use of cocaine appears after the first, or even after repeated taking of the drug…”
The name Merck cocaine has stuck, ever since Merck of Germany became a major supplier of the stuff starting in the early 1800s, according to Steven Karch’s A Brief History of Cocaine. (Its American subsidiary split off after World War I). In the U.S., Parke-Davis—now part of Pfizer was the dominant player. Karch says that both Merck and Parke-Davis paid Freud to test cocaine, and endorse their product. He obviously came through.
When not consumed by artists, pharmaceutical cocaine is typically used as a local anesthetic, especially by ear, nose, and throat doctors.
PS: Keith Richards just turned 67 on December 18. New Musical Express was so wrong.
Sunday, December 26, 2010
It is better to give than receive
A statement said that the ministry will asses and investigate how much is missing from the $42 million worth of medical goods the U.S. has donated this year.
The statement came after Afghan Defense Minister Gen. Abdul Rahim Wardak told The Associated Press last week that an investigation had been launched into the issue, and that Surgeon General Ahmad Zia Yaftali had been removed from his post as part of the inquiry. Three officials from the country's top medical facility, Dawood National Military Hospital in Kabul, were fired, he said then.
It's unclear just how much has disappeared from the medical goods the U.S. has donated this year. U.S. officials say they do not account for the supplies after delivering them to the Afghans.
http://news.yahoo.com/s/ap/20101226/ap_on_re_as/as_afghan_missing_medicine
Saturday, December 25, 2010
Friday, December 24, 2010
Mylan to Pay $65 Million Over Drug Prices - NYTimes.com
Mylan, a generic-drug maker, agreed to pay $65 million to settle a lawsuit by the federal and Texas governments asserting that the company had inflated prescription drug prices, increasing the cost of reimbursing pharmacies and other providers. The company admitted no wrongdoing in agreeing to the payment. Since 2003, Mylan has been sued by 18 states making similar allegations, according to the company’s 2009 annual report. Last year, Mylan, AstraZeneca and Johnson & Johnson agreed to pay $124 million to settle claims they violated laws by underpaying Medicaid rebates, the Justice Department said.
Faculty still paid by drug firms | Philadelphia Inquirer
Officials at the University of Pennsylvania believed they had a strong tool to prevent pharmaceutical-company money from corrupting the medical faculty.
In 2006, they acted to keep drug marketers out of their hospital and clinics, to ensure that treatment decisions were made for the right reasons. In one of the country's first policies of its kind, Penn also told its physicians that they "should not participate in industry marketing activities."
Penn's chief medical officer, P.J. Brennan, said he thought the policy was clear: Company-paid lectures are forbidden. "It flies in the face of what a professional ought to be," he said.
But an investigation by ProPublica found that 20 of Penn's doctors have delivered such lectures since 2009. Five, including one who left Penn last month, were paid more than $40,000.
Told of the findings, Brennan said Penn needs to make its policy more explicit.
He was not the only school official caught off-guard. ProPublica checked on 12 medical schools and teaching hospitals and found that faculty at half also lectured for drug firms in the last two years, despite restrictions on such speeches. Among them, Stanford University, the University of Pittsburgh, and the University of Colorado Denver have initiated reviews.
Thursday, December 23, 2010
Inspiration and Chai
REGRETS OF THE DYING
For many years I worked in palliative care. My patients were those who had gone home to die. Some incredibly special times were shared. I was with them for the last three to twelve weeks of their lives.
People grow a lot when they are faced with their own mortality. I learnt never to underestimate someone's capacity for growth. Some changes were phenomenal. Each experienced a variety of emotions, as expected, denial, fear, anger, remorse, more denial and eventually acceptance. Every single patient found their peace before they departed though, every one of them.
When questioned about any regrets they had or anything they would do differently, common themes surfaced again and again. Here are the most common five:
1. I wish I'd had the courage to live a life true to myself, not the life others expected of me.
This was the most common regret of all. When people realise that their life is almost over and look back clearly on it, it is easy to see how many dreams have gone unfulfilled. Most people had not honoured even a half of their dreams and had to die knowing that it was due to choices they had made, or not made.
It is very important to try and honour at least some of your dreams along the way. From the moment that you lose your health, it is too late. Health brings a freedom very few realise, until they no longer have it.
2. I wish I didn't work so hard.
This came from every male patient that I nursed. They missed their children's youth and their partner's companionship. Women also spoke of this regret. But as most were from an older generation, many of the female patients had not been breadwinners. All of the men I nursed deeply regretted spending so much of their lives on the treadmill of a work existence.
By simplifying your lifestyle and making conscious choices along the way, it is possible to not need the income that you think you do. And by creating more space in your life, you become happier and more open to new opportunities, ones more suited to your new lifestyle.
3. I wish I'd had the courage to express my feelings.
Many people suppressed their feelings in order to keep peace with others. As a result, they settled for a mediocre existence and never became who they were truly capable of becoming. Many developed illnesses relating to the bitterness and resentment they carried as a result.
We cannot control the reactions of others. However, although people may initially react when you change the way you are by speaking honestly, in the end it raises the relationship to a whole new and healthier level. Either that or it releases the unhealthy relationship from your life. Either way, you win.
4. I wish I had stayed in touch with my friends.
Often they would not truly realise the full benefits of old friends until their dying weeks and it was not always possible to track them down. Many had become so caught up in their own lives that they had let golden friendships slip by over the years. There were many deep regrets about not giving friendships the time and effort that they deserved. Everyone misses their friends when they are dying.
It is common for anyone in a busy lifestyle to let friendships slip. But when you are faced with your approaching death, the physical details of life fall away. People do want to get their financial affairs in order if possible. But it is not money or status that holds the true importance for them. They want to get things in order more for the benefit of those they love. Usually though, they are too ill and weary to ever manage this task. It is all comes down to love and relationships in the end. That is all that remains in the final weeks, love and relationships.
5. I wish that I had let myself be happier.
This is a surprisingly common one. Many did not realise until the end that happiness is a choice. They had stayed stuck in old patterns and habits. The so-called 'comfort' of familiarity overflowed into their emotions, as well as their physical lives. Fear of change had them pretending to others, and to their selves, that they were content. When deep within, they longed to laugh properly and have silliness in their life again.
When you are on your deathbed, what others think of you is a long way from your mind. How wonderful to be able to let go and smile again, long before you are dying.
Life is a choice. It is YOUR life. Choose consciously, choose wisely, choose honestly. Choose happiness.
Astra and Abbott abandon Certriad
LONDON (SHARECAST) - Pharmaceuticals giants AstraZeneca and Abbott have dissolved their collaboration agreement covering the development of Certriad capsules.Certriad is an investigational compound that was being jointly developed for the treatment of mixed dyslipidemia.
The co-development and licence agreement with Abbott will end on 22 January 2011, Astra said.
The decision was reached after careful review of a Complete Response Letter for the Certriad new drug application issued by the US Food and Drug Administration (FDA) on 30 March 2010.
With the resulting regulatory delay the two companies decided that the development of Certriad is no longer commercially attractive.
Wednesday, December 22, 2010
J&J Overcharged for Medications, AIDS Group Says in Lawsuit - BusinessWeek
Dec. 22 (Bloomberg) -- Johnson & Johnson was sued by an AIDS treatment group that said the drugmaker overcharged for medications purchased under a federal program.
In the lawsuit, the AIDS Healthcare Foundation accused J&J, the world’s largest health products company, of failing to provide discounts required by federal law for medicines used by nonprofit charities that provide treatment for people with HIV, the AIDS-causing virus. The suit named J&J’s Centocor Ortho Biotech and Tibotec Therapeutics units.
The AIDS group claims that J&J overcharged it by more than $68,000 for the medications from Jan. 1 to June 30, according to the suit filed yesterday in U.S. District Court in Los Angeles. In November, AIDS Healthcare filed a similar suit against Bristol-Myers Squibb Co., said Michael Weinstein, the group’s president, in a telephone conference call today.
FDA says Abbott Labs recalling up to 359 million blood sugar testing strips for diabetics - Courant.com
WASHINGTON (AP) — The Food and Drug Administration says Abbott Laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings.The testing strips are used to help diabetes patients check their blood sugar levels. But the FDA says the products being recalled by Abbott can give inaccurately low measurements. As a result, patients may try to raise their blood sugar levels unnecessarily or fail to detect dangerously high blood sugar levels.
DH cancer czar - Cancer Drugs Fund "extremely unlikely" to alter survival difference | Health Policy Insight
Publish Date/Time:12/22/2010 - 07:59Regular readers know our views on the Government's absolutely discriminatory, NICE-undermining National Cancer Drugs Fund: not only is it a crap idea, it is a populist crap idea.
We have done this again and again and again and again and again and again and again.
So bravo for DH cancer czar Professor Mike Richards, who told Jeremy Laurance of The Independent that he pretty much agrees.
Responding to findings by Coleman and colleagues in The Lancet's comparative study of international performance on treating cancer (in which the NHS fares poorly), Richards said of the £200-million-a-year (from next year; £50 mil has to get us up to 31 March) National Cancer Drugs Fund "It is extremely unlikely any issue of access to drugs makes any difference to these survival differences. Drugs have a very modest impact on survival, prolonging it by three months or so.".
Professor Richards may not court popularity with these words. But he is right.
Jeremy Laurance kindly quotes our exclusive report of Richards' words at an ABPI event in November saying "if you wanted to sufficiently change outcomes from cancer I would not spend £200 million on expensive cancer drugs; I would spend it on earlier diagnosis and involving GPs". Unfortunately, The Independent's sub-editors must have excised the reference.
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Merck to pay $280 million Dey settlement - UPI.com
BASKING RIDGE, N.J., Dec. 21 (UPI) -- German drug maker Merck KGaA is responsible for paying a $280 million settlement Dey Pharma LP reached with the U.S. government, Mylan Inc. says.
Mylan, the New Jersey pharmaceutical giant that acquired Dey in 2007, said in a release following Monday's announcement of the settlement of the Medicare and Medicaid reimbursement lawsuit that Merck also is on the hook for all costs and expenses related to similar pending and future suits involving its subsidiary.
The U.S. Justice Department's lawsuit began before Mylan acquired Dey.
Mylan said the settlement agreement is not an admission, finding, or evidence of fault, liability or wrongdoing by Dey.
The Justice Department alleged Dey reported false prices for Albuterol Sulfate, Albuterol MDI, Cromolyn Sodium and Ipratropium Bromide, resulting in excessive payments on millions of claims paid by Medicare and Medicaid.
Merck Serono chief Elmar Schnee leaves for "personal reasons"
The announcement came hours after the Financial Times Deutschland had reported that Merck would not be extending Mr Schnee’s contract due in part to the clinical setbacks the firm has suffered of late. Last month, the US Food and Drug Administration extended its review period for the company’s multiple sclerosis pill cladribine, which was rejected by advisors to the European Medicines Agency in September.
Ex-Glaxo Lawyer Facing Charges Seeks King & Spalding Records, Filings Show - Bloomberg
A former GlaxoSmithKline Plc lawyer charged with obstructing a regulatory review of the company wants prosecutors to disclose data on law firm King & Spalding LLP’s work for the drugmaker during the probe.
Lawyers for Lauren Stevens asked the U.S. Justice Department to hand over files about Atlanta-based King & Spalding’s work on a 2002 Food and Drug Administration inquiry into Glaxo’s marketing of its Wellbutrin SR antidepressant, a Dec. 17 court filing shows.
Stevens, indicted last month on charges she obstructed the probe into whether Glaxo marketed Wellbutrin for unapproved uses, intends to tell jurors in her Feb. 1 trial that she relied on “advice of counsel” when making allegedly false statements about sales tactics, prosecutors said in a separate Dec. 17 filing in federal court in Greenbelt, Maryland.
“In responding to the FDA, the defendant worked with other attorneys, including both in-house GSK attorneys and attorneys from an outside law firm,” prosecutors said in the filing, while opposing Stevens’s request. They didn’t name King & Spalding.
Legal Advice
Stevens’s defense lawyers want all documents that “establish King & Spalding LLP received material information on which the firm based its legal advice with respect to GSK’s responses” to the FDA’s 2002 inquiry, according to a Dec. 7 letter included in court filings.
Mary Anne Rhyne, a Glaxo spokeswoman based in North Carolina, declined to comment on King & Spalding’s role in representing the London-based company in the FDA review.
Les Zuke, King & Spalding’s spokesman, said the firm wouldn’t comment on Stevens’s filing or any work done on behalf of Glaxo. Christina Sterling, a Boston-based spokeswoman for prosecutors, didn’t immediately return a phone call and e-mail seeking comment.
Prosecutors contend that Stevens, who lives in Durham, North Carolina, “engaged in a year-long effort” to deceive the FDA about the company’s off-label marketing campaign for Wellbutrin, according to court filings.
Under U.S. law, a doctor can prescribe a medicine for any condition, as long as the FDA has found its safe and effective. Drug companies aren’t allowed to promote a drug for uses other than those approved by the FDA.
In response to regulators’ request for information about Wellbutrin’s marketing in October 2002, Stevens allegedly sent a series of letters “that falsely denied the company had promoted the drug for off-label uses, even though she knew” the drugmaker had sponsored such marketing programs, prosecutors said in court filings.
Promotional Talks
The indictment alleges Stevens knew the company paid “numerous physicians to give promotional talks to other physicians” about unapproved uses for Wellbutrin and failed to provide slides given to the speakers, prosecutors claim.
Evidence will show that “a legal memorandum was prepared for Stevens that set forth the pros and cons” of producing the slides for the FDA, prosecutors said.
Stevens was warned in the memo that some of the slides “would provide incriminating evidence about potential off-label promotion of Wellbutrin SR that may be used against GSK in this or a future investigation,” prosecutors said. The government didn’t say who prepared the memo.
The case is being tried in the Maryland suburbs of Washington because the FDA is based in the area. In their letter to prosecutors, Stevens’s lawyers asked for all documents “from King & Spalding LLP regarding” the FDA’s request for Wellbutrin information.
Clarify Charges
They also want all statements by the law firm’s lawyers “related to their understanding that GSK employees did not promote Wellbutrin for off-label uses or that GSK management did not encourage” off-label sales of the drug, according to the letter.
The defense also asked U.S. District Judge Roger Titus to order prosecutors to clarify the charges against Stevens. She is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements.
The first two charges carry maximum terms of 20 years, and the others carry terms of five years.
Defense lawyers contend that they shouldn’t have to “sift through millions of pages” of documents to identify statements and files prosecutors seek to use against Stevens.
“A review of the millions of documents alone will not enable Ms. Stevens to determine which statements the government alleges are false and which documents it alleges Ms. Stevens falsified, altered or concealed,” according to the filing.
The case is U.S. v. Stevens, 10-cr-694, U.S. District Court, District of Maryland (Greenbelt).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net
To contact the editor responsible for this story: David E. Rovella at drovella@bloomberg.net.