When Timothy P. Murray crashed his government-issued Ford Crown Victoria in 2011, he was fortunate, as car accidents go. Mr. Murray, then the lieutenant governor of Massachusetts, was not seriously hurt, and he told the police he was wearing a seat belt and was not speeding.
The power of computing, and the thrill of its apparently infinite possibilities, has also long been a source of fear.
Going into a San Francisco second-hand book shop, shortly before a visit to Google’s headquarters in California, I happened upon a copy of Dick Tracy, an old novel based on Chester Gould’s cartoon strip starring America’s favourite detective.
The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.
Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs.
Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.
While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle.
The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.
The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.
The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.
The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.
“Some who oppose full disclosure of data fear that publishing the information could reveal trade secrets, put patient privacy at risk, and be distorted by scientists’ own conflicts of interest. While many of the concerns are valid, critics say they can be addressed, and that openness is far more important for patient safety.”
Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry’s financial links with patient groups, said: “It’s incredibly ironic that this is a transparency initiative and we’ve now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner.
“It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There’s a hidden agenda here. The patient groups will say they think it’s a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.
“Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we’re not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,” he added.
A recent review of medical research estimated that only half of all clinical trials were published in full, and that positive results were twice as likely to be published than negative ones.
A source in the European parliament, who is close to the negotiations over the clinical trials directive, said he had experienced intense lobbying from patient groups. “We’ve witnessed this sort of activity in recent months, and it’s a concern if the pharmaceutical industry is behind some of it. They are trying to weaken some of the transparency proposals and that’s clear from the amount of lobbying we’ve had,” he said.
The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.
“These aren’t completely unfounded concerns, but the risk already exists, and those things already happen. The answer is to have a responsible scientific community that can counteract the allegations and claims,” the source said.
Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. “That is deemed to be happening in any case,” the memo concedes.
In response to queries from the Guardian, GSK said: “This is not something we are doing. One of the reasons we’re involved in this is we want more companies to move towards greater transparency. I don’t think it’s for us to be mobilising patient groups to campaign on a negative level.”
A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but “to our knowledge Roche has not been involved in any EFPIA’s potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”.
A Lilly spokesman said: “Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly’s integrity in business policy.”
Individuals who received the memo at several other companies, including AstraZeneca and Novartis, did not respond.
Tracey Brown, director of the campaign group, Sense about Science, and co-founder of AllTrials, a campaign to get all clinical trials registered and all results reported, said: “We now have the prospect of really significant developments to end the secrecy and make clinical trial reporting a practical reality and, finally, some sound commitments from parts of industry.
“In this context, the industry associations’ strategy to get others to raise further spurious problems is backward. It should embarrass anyone associated with it. I would say to the individual companies that they should publicly distance themselves from any association with EFPIA and PhRMA’s strategy now,” she said.
The EFPIA told the Guardian it had been working with PhRMA on a “commitment to enhance sharing of clinical data” to researchers and the public, and intended to make an announcement this week.
“Knowing that some people want all data to be made available to everyone, EFPIA is engaging with stakeholders to share concerns with harmful ‘re-use’ of data. We will engage not only with patient groups, but also with the scientific community,” it said.
Matt Bennett, senior vice-president of PhRMA, said in a statement: “EMA’s proposed policies on clinical trial information raise numerous concerns for patients. We believe it is important to engage with all stakeholders in the clinical trial ecosystem, including the patients who volunteer to participate in clinical trials, about the issue.
“If enacted, the proposals could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health.”
The chairman of the Senate Judiciary Committee is pushing to fast-track legislation that would require police to obtain a warrant before accessing emails and other private online messages.
Former U.S. Navy SEAL Dom Raso recently appeared in an NRA News segment, slamming gun control advocates like Mayor Michael Bloomberg and his “crew of puppets” for their actions.
“I am getting more and more tired of celebrities, politicians, and high-ranking officials who don’t know what they’re talking about lecturing us on gun control,” Raso began. “…A few months ago they were proudly talking about gun control. Now they’ve changed their language to ‘gun safety,’ as if that’s fooling anyone. What the hell is gun safety legislation anyway?” Continue reading “Former Navy SEAL Dom Raso Blasts Pro-Gun Control Puppets.”
The following is an excerpt from Our Lost Hope: Rediscovering the Lost Path to Liberty
We all intuitively understand – we need rules. And we must follow them.
The U.S. Constitution provides a framework, the rulebook, if you will, for the federal government; each clause, each principle, carefully crafted for a specific reason. The entire document aims to define, constrain and control federal power. When we begin to ignore and rewrite various checks and balances written into the Constitution by the framers, we tear at the very fabric of the Republic. And we run the risk of unleashing a torrent of power that will soon wash away the freedoms and liberties the founders cherished. Continue reading “Who’s the Boss?”
The United States Navy successfully launched a huge communications satellite today (July 19), adding the second piece to a constellation that should provide a big boost to American troops.
Anyone that thinks that the U.S. economy can keep going along like this is absolutely crazy. We are in the terminal phase of an unprecedented debt spiral which has allowed us to live far, far beyond our means for the last several decades. Unfortunately, all debt spirals eventually end, and they usually do so in a very disorderly manner. Continue reading “Share This Chart With Anyone That Believes The U.S. Economy Is Not Going To Crash”
The steel-gray U.S. Air Force Predator drone plunged from the sky, shattering on mountainous terrain near the Iraq-Turkey border. For Kurdish guerrillas hiding nearby, it was an unexpected gift from the propaganda gods.
Most everyone understands that smoking weed feels great – yet, some will deny themselves that state of bliss. Fearful of repercussions from the many different law enforcement entities that hate pot out of ignorance, many suffer in silence. However, with a new study out indicating marijuana’s ability to mitigate the symptoms of opiate withdrawals in subjects undergoing methadone maintenance treatment, many may soon find themselves reevaluating marijuana as a new Anti-Gateway drug? Continue reading “Marijuana Study: Cannabis Mitigates Opiate Withdrawal Symptoms”
The Bureau of Alcohol, Tobacco, Firearms and Explosives released a 60-day notice on Wednesday requesting comments on a proposed change to its Application to Make and Register a Firearm, Form Number: ATF F 1 (5320.1). The notice is published in the Federal Register for Monday, July 22, available online now.
“The form is used by persons applying to make and register a firearm that falls within the purview of the National Firearms Act,” the notice explains. “The information supplied by the applicant on the form helps to establish the applicant’s eligibility. Continue reading “ATF requests public comments on firearm application form”
As quoted in the Moscow Times, July 20, 2013, Russia’s chief sanitary inspector,Gennady Onishchenko, has accused the U.S. of producing biological weapons in a Georgia at a U.S. Navy facility that is run in concert with the Georgian government.
The facility, the Center Public Health Reference Laboratory (CPHR), is situated on a former Soviet military base and is located on the outskirts of Tbilisi. Here, the U.S. government is conducting activities in violation of the 1975 Biological Weapons Convention, Onischenko told Interfax on Saturday. Continue reading “Russian Official Accuses U.S. of Biological Weapons Violations”
The recent seizure of a North Korean freighter carrying Cuban, nuclear-capable SA-2 missile components for refurbishment has resurrected the spectre of the 1962 Cuban missile crisis, when another communist nation developed nuclear dealings with America’s island neighbor.
Richard Fisher, a military affairs specialist, explained the significance of the shipment, which was captured in the Panama Canal: “North Korea, a country soon to be in a position to export nuclear warhead armed ballistic missiles, now has a missile relationship with Cuba.” Continue reading “U.S. Faces Brand-New Cuban Missile Crisis”
House Minority Leader Nancy Pelosi (D-Calif.) said her party is “blessed with such a great supply of riches” since Hillary Clinton and Joe Biden are rumored to be running for president in 2016.