Why does it always take ordinary people to affect real change in corrupt medicine?
The Valproate activists have done great work.
Kudos to them.
Cover Up? Paxil and Suicide Risk
Yes, it appears the makers of Paxil may have been a bit disingenuous in their publication of the risks of suicide associated with their medication back in the early 1990s. The U.S. Senate has made available an in-depth report (4 MB PDF) written by Joseph Glenmullen, a Harvard psychiatry professor, who examined the drug company’s data on Paxil. There apparently were some serious discrepancies in the original researchers’ data analysis.
One of those discrepancies was a pretty big one — that Paxil resulted in a suicide rate 8 times greater than a sugar pill. That’s a huge, major difference.
The researchers were clever in their cover-up. They included 2 people who apparently committed suicide before the study even began and attributed their suicides to the placebo control group. Nobody, of course, would’ve ever discovered this creative data interpretation if it weren’t for a lawsuit filed against GlaxoSmithKline (the makers of Paxil) in California.
There isn’t much dispute about whether the original researchers’ data analysis was proper in any form, manner or universe — it wasn’t. It was a crass manipulation of the data in order to gain market approval for the drug (which was later accepted by the FDA as a part of the drug’s safety and efficacy new drug application).
The report also noted that suicides during these kinds of research trials should be fairly rare anyways, because the researchers specifically stack the cards:
During the wash-out period [a period of 1 to 2 weeks before the study begins where subjects are removed from all existing medications], all patients are given daily placebo pills. Hence, another name for this pre-study period is the “placebo wash-out phase.” Patients whose depressions quickly improve during this time are labeled “placebo responders” and excluded from the actual study. Administering a placebo during the wash-out phase is also a technique used by pharmaceutical companies to wee out patients who would respond quickly to a placebo in the official study. This weakens the performance of the placebo by removing quick placebo responders, thereby making the performance of the antidepressants look better.
Pharmaceutical companies use this technique because the placebo effect accounts for such a high percentage of an antidepressant’s effect. According to the FDA, the placebo effect accounts for about 80% of the effect of antidepressants. […] If the pharmaceutical companies did not use the placebo wash-out procedure, the difference between placebo and antidepressants would be even smaller. Thus, the placebo wash-out phase accomplishes two tasks: washing out patients’ old drugs and weeding out placebo responders.
In other words, some pharmaceutical companies go to great lengths to “stack the deck” to ensure that when the study begins, they get the best results possible.
Keep in mind, too, that anyone who is seriously suicidal or depressed is actually excluded from participating in these kinds of studies. This only reinforces the importance of these findings — these are people who were not actively or seriously suicidal before taking Paxil.
Many psychiatrists and doctors consider Paxil a good “go-to” antidepressant for folks with depression and a little anxiety. It tends to be more calming than some other SSRI antidepressants, and therefore was very widely prescribed in the 1990s and even now. Undoubtedly such prescriptions have helped millions of Americans over the past two decades in grappling with their depression.
But it likely has also caused more harm than doctors or patients were aware of, because of these kinds of data manipulations that understated the risk of suicide.
I sincerely hope pharmaceutical companies are learning from these mistakes — all research data will eventually become public knowledge. So ensure you don’t cut any corners to get your drug approval, or else the chickens will come home to roost one day.
New Post from the always excellent… Dr Peter Gordon…
Science is important to us all. This post is an attempt to explore some of the broad issues that we need to consider to ensure scientific integrity.
Science is more than a word. It is about a world of understandings translated into language. This is wonderfully ambitious but does mean that content is lost as experience is translated into words. There is further loss as this is translated into the singular language of science. The next step is often to “convert” this language into numbers. So at each stage in the scientific process the content of experience is diminished.
Up until the early 19th century science included the humanities. From 1830 onwards, in the Western world at least, science became more narrowly defined and understood.
It is my view that science needs to return to the more natural and encompassing approach of the so-called enlightenment period. “Evidence-base” needs to be…
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GSK Hides Dangerous Side-effects of Epilepsy Drug, Lamictal
While we all know that any drug comes with side-effects, it’s critical that drug companies and foundations tell the public the truth about those side-effects.
In this Video:
- Learn how drug giant GlaxoSmithKline lied to the FDA and withheld critical information tying their seizure medication Lamictal to a devastating condition known as Steven Johnson Syndrome (SJS) and even toxic epidermal necrolysis (TEN).
- How their Drug increases suicide and suicidality by more than 3 fold.
- How the Epilepsy Foundation fails to mention the corruption/fraud behind this drug and the real risks of life altering permanent side-effects.
Watch as Dr. Dale breaks down the problems with Big Pharma fraud and The Epilepsy Foundation’s misinformation regarding the true risk of Lamictal.
It is my hope that as a community and nation we can drive real change and end corruption within medicine.
“…It is very important that companies like Insys be held responsible for corrupting the medical community, as well as endangering and sometimes killing innocent patients..”
A former pharmaceutical chief executive pleaded guilty to playing a part in a sophisticated scheme to give kickbacks to doctors who prescribed his company’s fentanyl-based opioid drugs — a move one top lawyer said is one step toward the goal of cutting down the corrupt greed that’s “alive and well in the pharma business.”
Michael Babich, the former CEO at Insys Therapeutics, pleaded guilty in federal court in Boston on Wednesday for his role in a nationwide scheme to bribe physicians to prescribe the company’s oral-spray painkillers meant for cancer patients facing extreme pain.
“It is very important that companies like Insys be held responsible for corrupting the medical community, as well as endangering and sometimes killing innocent patients,” said attorney Mike Moore, who’s leading some efforts to sue pharmaceutical companies two decades after securing a massive settlement against tobacco companies.
Moore, the former Mississippi attorney general, added, “Greed is alive and well in the pharma business and must be weeded out.”
Cases remain open against several of Babich’s alleged co-conspirators. The company paid half a million dollars two years ago after Massachusetts Attorney General Maura Healey’s office sued it on similar claims.
Sitting before a federal judge, Babich, 42, admitted he used Insys as a vehicle to bribe doctors into prescribing Subsys to patients who did not have cancer — a scheme that ended up lining his own pocket with $3.5 million more in profit, an amount he has agreed to give up. Those physicians would write Subsys prescriptions for no legitimate medical purpose, according to prosecutors.
Babich and the other officials disguised bribes and kickbacks in the form of speaking fees, the feds said, adding that Insys executives would punish those who didn’t write enough prescriptions.
Alec Burlakoff, a former sales vice president for Insys, pleaded guilty to racketeering conspiracy in November and agreed to cooperate with investigators. Babich, who faces up to 25 years behind bars, also will cooperate.
U.S. Attorney Andrew Lelling attended the court hearing Wednesday. His office declined to comment, citing the pending related cases.
Boston Mayor Martin J. Walsh said, “Boston has reached a breaking point in the fight against the opioid epidemic. We have a public health crisis on our hands that has steadily gotten worse in recent years and even though we have been increasing access to critical treatments and supports, we can’t fight this alone. It’s time to hold accountable the companies that created and fostered this crisis and pursue remedies to stop its harmful marketing tactics.”
LinkedIn censored the profile and activities of a vocal critic of the Chinese government for users in China, in another apparent response to a censorship request from the government.
Corporate fraud investigator Peter Humphrey, who is British and lives in the UK, was informed by LinkedIn in December that his profile had been censored in China, but after being asked about it by BuzzFeed News this week, LinkedIn restored the page and said it had only been blocked in error.
It comes days after LinkedIn censored the page of a pro-democracy activist in China before also later restoring it after a wave of negative publicity.
Humphrey, 62, and his wife, Yu Yingzeng spent 23 months in jail in China after a court found them guilty in 2013 of illegally obtaining private information about Chinese citizens. Humphrey has said the charges were without basis and written about the grueling treatment he received in detention.
Since his release, Humphrey has been highly critical of Chinese government policy and recently filed a complaint with the British broadcasting regulator over the license given to Chinese state broadcaster China Central Television (CCTV) — the network that once broadcast a video of him in an orange jumpsuit giving a forced confession while he was in detention.
Reached by phone, Humphrey said he believed posting about that complaint prompted Microsoft-owned LinkedIn to censor his profile. He received a notice from the social network on Dec. 24 last year, according to a message he shared with BuzzFeed News, saying his profile would be blocked in China because of the “presence of specific content.”
“It made me feel sick in my stomach,” he said. “This is supposed to be a company operating in the environment of free flow of information. An American company where you have a constitutional amendment that makes freedom of expression sacred.”
Asked why Humphrey’s profile had been removed in China, Nicole Leverich, a spokesperson for LinkedIn, said an internal review found the profile was “blocked in error.” It has now been restored for users in China, she said.
“Our Trust and Safety team is updating our internal processes to help prevent an error like this from happening again,” she added. She did not say why Humphrey’s profile was blocked in the first place.
The message from LinkedIn is worded very similarly to a message sent last week to US-based pro-democracy activist Zhou Fengsuo. In Zhou’s case, the company said the decision to block his profile and activities in China had been a mistake and restored them.
“This is not just about me,” Humphrey said by email after being told his profile had been restored. “How many of these ‘mistakes’ do they make without being forced to correct them? This is not only a China problem. It’s the world’s problem.”
These incidents underscore the increasing difficulty for Western technology companies of operating in the Chinese market — even for LinkedIn, which is best known as a platform for professional networking rather than political discussion. LinkedIn is obligated to respond to government requests to censor content for users based in China as a condition for it continuing to operate in the country. It is one of the few non-Chinese social networks that is not blocked there — Facebook, YouTube, and Twitter are all inaccessible unless the user disguises their location using a VPN.
China operates one of the most sophisticated internet censorship systems in the world, and the government under President Xi Jinping has taken an increasingly aggressive approach to controlling speech online.
Chinese social networks are heavily censored but users in the country usually see individual posts being taken down rather than whole profiles.
US-based tech companies have recently come under scrutiny for appearing to accept censorship demands from authoritarian governments. Netflix this month took down an episode of Hasan Minhaj’s comedy show for users in Saudi Arabia, apparently because it was critical of the Saudi government. And Google faced pressure from the public as well as its own employees over a plan to build a censored version of its search engine for the Chinese market. Following the backlash, Google CEO Sundar Pichai told Congress the company had no plans to launch a search engine in China “right now.”
“These companies were born and bred and allowed to flourish because of the principled values and legal environment we have in the US or Britain, allowing them to be platforms for the free flow of information,” Humphrey said. “They should not bend to this kind of despotic pressure and submit to censorship.”
Google says it has no plans to launch a search product in China right now. A previous version of this post said the project had been cancelled.
New Post From Ethical Psychiatrist Peter Gordon …
The above is a quote from Roy Porter a historian specialising in the history of medicine. It is an old quote as sadly Roy Porter died at a young age in 2002.
It is some weeks now since I resigned from the Royal College of Psychiatrists having been a member for almost a quarter of a century. My intention is to switch focus to my other areas of interest.
The following is a summary of the two main areas that I raised in my letter of resignation [it is my understanding that the Royal College of Psychiatrists does not intend to reply to this letter].
The first area of concern related to:
This College statement includes the following:
[In previous posts I have used information available in the public domain to construct visual summaries of the competing interests of some key opinion leaders. I have done so in the spirit…
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A GSK Korea sales manager in charge of consumer healthcare division jumped to his death off the company headquarters in Yongsan-dong, Seoul, on Thursday.
According to local reports, police arrived at the scene after someone reported that a man had jumped off the building. The sales manager, surnamed Song, had already died when the police arrived at the scene.
The reason behind Song’s death is still unknown and the police are investigating the incident based on CCTV recordings.
Medipana, an internet medical media outlet, reported that the police have also found Song’s suicide note.
“Based on the fact that Song left a suicide note, acquaintances of Song are worrying that he may have fallen to his death due to stress at work,” it said.