"Scamiflu...Demasiado Tamiflu.

A review of all the clinical trial evidence for flu medications Tamiflu and Relenza has found that they are not as effective as they seemed when only some of the data was assessed. 

pic: @pharmagossip

 The new review is based on detailed clinical study reports from clinical trials of the drugs which the researchers from Cochrane Collaboration have spent four and a half years battling to access. It shows there is no good evidence that the drugs prevent the spread of flu or reduce dangerous complications and only helped reduce symptoms by half a day compared to not using the drugs. 

 The UK government has spent £473 million on Tamiflu and £136 million on Relenza since 2006, and other countries have stockpiled it too. When the government made the decision to stockpile the medications its medicines regulator MHRA had not seen all of the evidence.(...) 

Dr Ben Goldacre, author and co-founder of AllTrials: This is a pivotal moment. Tamiflu has become the poster child for clinical trials transparency, and it illustrates perfectly why researchers need access to the full methods and results of all trials, to help doctors and patients make informed decisions about treatments. But we must remember that Roche broke no laws, and Tamiflu is not an isolated case. The evidence clearly shows that important information on the methods and results of clinical trials on the treatments we use today are still being routinely and legally withheld, throughout medicine. 

Roche have slowly become more transparent, and should be applauded for this. Many other companies are still lagging behind. Some, such as InterMune, are still suing regulators to make them withhold trials information. Regulators, policy makers, and public health officials must demand full access to the methods and results of all trials, on all treatments currently in use. But industry itself has much to gain by supporting transparency. The world has changed, and they must change with it.” (Más)

Revisa todo sobre Tamiflú en PHARMACOSERÍAS

Revisa todo sobre Ben Goldacre en PHARMACOSERÍAS

Revisa todo sobre "All Trials" en PHARMACOSERÍAS

Ver también:
Demasiado Tamiflú

Del "off-shoring" en investigación clínica y/o el "deconstruir*" la "Doctrina Acebillo..."

Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

.../...

$350 per Child

If the globalization of clinical trials for adult medications has drawn little attention, foreign trials for children’s drugs have attracted even less. The Argentinean province of Santiago del Estero, with a population of nearly a million, is one of the country’s poorest. In 2008 seven babies participating in drug testing in the province suffered what the U.S. clinical-trials community refers to as “an adverse event”: they died. The deaths occurred as the children took part in a medical trial to test the safety of a new vaccine, Synflorix, to prevent pneumonia, ear infections, and other pneumococcal diseases. Developed by GlaxoSmithKline, the world’s fourth-largest pharmaceutical company in terms of global prescription-drug sales, the new vaccine was intended to compete against an existing vaccine. In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Their parents, some illiterate, had their children signed up without understanding that they were taking part in an experiment. Local doctors who persuaded parents to enroll their babies in the trial reportedly received $350 per child. The two lead investigators contracted by Glaxo were fined by the Argentinean government. So was Glaxo, though the company maintained that the mortality rate of the children “did not exceed the rate in the regions and countries participating in the study.” No independent group conducted an investigation or performed autopsies. As it happens, the brother of the lead investigator in Santiago del Estero was the Argentinean provincial health minister.

.../...

In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. So far, these deaths have triggered no medical crusades, no tough new regulations. After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.

And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.

Mas...

USA: Preocupa el "off-shoring" en investigación clínica

"Doctrina Acebillo**" (Presidente de Novartis en España, ex Presidente de Farmaindustria)

"Las economías emergentes ofrecen, asimismo, oportunidades para mejorar los procesos de innovación a costes altamente competitivos, sobre la base de personal científico e investigadores muy competentes, formados en su mayoría en centros de excelencia investigadora de EEUU y Europa.
Esta oferta altamente cualificada está en el origen de lo que se denomina "off-shoring" o "externalización global", es decir la externalización de un número de operaciones de alto valor añadido, a proveedores situados en los mercados emergentes, en condiciones más atractivas y competitivas que las que ofrecen los especialistas y proveedores occidentales. China, India, Singapur y el este de Europa entre otros, son ejemplos claros de países emergentes que han priorizado el desarrollo de "Clusters" biotecnológicos de alta competitividad, donde se ofrecen servicios de I+D del más alto nivel científico, con compromisos óptimos de tiempos de ejecución y a unos costos muy por debajo de los existentes en los países desarrollados." La coincidencia en el espacio y en el tiempo de altos niveles tecnológicos, junto a bajos costes operativos es la causante de un desplazamiento histórico de riqueza y valor, desde el rico occidente al este emergente."

HUMOR...es lunes: Deslocalización...Jesus Acebillo la llama "off-shoring" o "externalización global" que suena mas bonito...

(*) La deconstrucción ( Jacques Derrida pensador francés n.1930, en El-Biar, Argelia) tampoco es una crítica en el sentido de una operación negativa, nihilista, irracional o escéptica. Frente a todas ellas, la deconstrucción acepta el riesgo y la necesidad de asumir de forma positiva, afirmativa, la única racionalidad que se da, es decir, una razón capaz de enfrentarse a su falta de garantías, de renunciar a su supuesta universalidad y de acoger su «otro» espúreo y conflictivo: la no-razón.

Cristina de Peretti/Diccionario de Hermenéutica.

(**) Since July 2004, in addition to his responsibilities as CEO, he (Jesús Acebillo) manages the new Emerging Growth Markets (EGM) Region from the Barcelona headquarters of Novartis Spain.
The EGM Region comprises China, India, Turkey, Russia, Australia, South Korea,, Taiwan, and the nations of the Asia Pacific region, the Middle East, Africa and Eastern Europe. These organizations are managed directly from Barcelona, with two international offices located in Singapore and Basel. (Web oficial de Novartis)Aviso para "navegantes..."

La "sombra" de Tamiflu es alargada y...de_Roche de dudas sobre la investigación farmacéutica.(I)

Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia. 

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story. 

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment. 

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn't in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.(Más en español)

El doctor David Tovey, Editor en Jefe de la Cochrane ha dicho: “Ahora tenemos la revisión más robusta sobre los ´inhibidores de la neuraminidasa´. Inicialmente pensado para reducir las hospitalizaciones y las complicaciones graves de la gripe, el informe pone de relieve que el Tamiflu no ha demostrado estos efectos y que tiene problemas que no fueron informados plenamente en las publicaciones originales. Esto demuestra la importancia de asegurar que los datos de los ensayos son transparentes y accesibles “. 

 
Más

 Y no solo en Europa se publican "denuncias"...

Consequences of human studies with unpublished results: what can be done? 

Data from clinical trials with widely prescribed drugs have not been published. Pregabalin, gabapentin, paroxetine, oseltamivir, zanamivir are only some examples of drugs in which Phase III trials remain unpublished several years after study completion. Unpublished clinical trials could result in negative consequences in the economy of healthcare systems and mislead therapeutic decisions in clinical practice. Oseltamivir (Tamiflu ®) is only one example in which unpublished data resulted in unfortunate decisions by policy makers around the world. Oseltamivir was approved for the treatment of influenza by the European Medications Agency (EMEA), the Food and Drug Administration (FDA), and the National Institute for the Surveillance of Medicines and Foods (INVIMA) in Colombia. Tamiflu was also recommended by The World Health Organization (WHO) and stockpiling of this drug was encouraged by the Centers for Disease Control and Prevention (CDC). During 2009 the Ministry of Social Protection from Colombia acquired more than 1 million doses of oseltamivir at a total price of $34,000 million colombian pesos (approximately $16 millions USD). Most doses of oseltamivir were never used and passed their expiration date. Agencies through the world did not review the full Tamiflu dataset before the publishing statements supporting recommendations encouraging their use, purchase, and stockpiling of this drug. To the present day, results for the majority of Roche's Phase III intervention trials for oseltamivir remains unpublished over one decade after their completion date. (Más)

 Ver también:

"Scamiflu...Demasiado Tamiflu.

 TAMIFLU: La mayor estafa de la historia

Si tú me dices Ben...lo creo todo: "Improving, and auditing, access to clinical trial results"

Authors: Ben Goldacre, Wellcome research fellow in epidemiology, Carl Heneghan, professor

All trials should be registered, with their full methods and results reported, and routine audit on the extent of information withheld 

 The House of Commons Public Accounts Committee delivered a remarkable report on 3 January. Its initial remit was the United Kingdom’s £424m (€510m; $697m) stockpile of oseltamivir (Tamiflu), but the committee soon broadened out—with evident surprise—into the ongoing problem of clinical trial results being routinely and legally withheld from doctors, researchers, and patients. 

This situation has persisted for too long. The first quantitative evidence on publication bias was published in 1986. Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises. Recent years have seen extensive denial. The Association of the British Pharmaceutical Industry (ABPI) has claimed that these problems are historic, and that results are now posted on clinicaltrials.gov. The recently defunct Ethical Standards in Health and Life Sciences Group, which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results. US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored, with no enforcement. There has also been covert activity from industry—a leaked memo on its “advocacy” strategy included “mobilising patient groups” to campaign against transparency.

Despite this, we have achieved considerable progress. The AllTrials.net campaign, 

Ver

AllTrials: De_ROCHE de escepticismo...

started 12 months ago, calls for all trials on all uses of all currently prescribed treatments to be registered, with their full methods and results reported. It now has the support of most medical and academic professional bodies as well as the National Institute for Health and Care Excellence (NICE), Medical Research Council, Wellcome, more than 130 patient groups, 60 000 members of the public, and many in industry including GlaxoSmithKline. The Health Research Authority has announced that registration will be a condition of ethics committee approval. The BMA has passed a motion stating that withholding trial results is research misconduct, and the General Medical Council is re-examining its guidance on the matter. (Más)

Por todo esto...Ben:

Ratón de biblioteca: Mala ciencia / Ben Goldacre

AllTrials (?): Big pharma "se aprovecha" (y moviliza) a los pacientes...en su favor.

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." (Más)

"Getting the right information to patients 

is a more pressing issue for the pharma industry 

than transparency of trial data," 

Roch Doliveux Ceo UCB

Slide: F.Comas/ Phamaggedon 2012. El día después...

Hace tiempo lo venimos denunciando...

Ver también:
AllTrials en PHARMACOSERÍAS

International Clinical Trials Day y...todos con AllTrials

Hoy es un buen día para firmar... 


It is International Clinical Trials Day on Tuesday 20th May 2014 and we cannot afford to lose momentum for AllTrials. Help us get to 100,000 signatures on the AllTrials petition. Here’s what you can do today: 

• Share the petition. Make it your goal to get 10 new signatures. Email it to your friends, family and co-workers, share it on Facebook and Twitter and share this image. It can be as simple as forwarding this email to your friends. 
• Get your organisation to join the campaign. AllTrials is supported by over 450 organisations including patient groups, universities, pharmaceutical companies, consumer groups and charities. Ask your company or professional body to email us about joining. 
• Donate to keep the campaign going. Thank you to everyone who has already donated. This campaign is supported by people like you. Every bit helps. 

Since the campaign began in January 2013, AllTrials supporters have been instrumental in bringing in a new law in Europe that requires future clinical drug trials to be registered and their results reported; our collective voice has made some pharmaceutical companies begin to register past clinical trials; and lawmakers around the world are beginning to feel the pressure to act. 

We will soon be launching a new website and campaign video to make a global call for all trials to be registered and all results reported. We already have commitments from many of our supporting organisations to post the video on their websites, and when it’s ready I’ll be asking you to do the same. 

We can’t let the momentum slip. Ask everyone you know to join the campaign.

USA: Preocupa el "off-shoring" en investigación clínica

WASHINGTON — Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was.

But according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites.

The report is scheduled to be released publicly on Tuesday, but a copy was obtained by The New York Times.

Ten medicines approved in 2008 were tested entirely abroad with not a single test patient in the United States, the report said.

In many cases, foreign trials provide invaluable information proving that drugs are effective in a variety of ethnic groups. Mr. Levinson’s report found that most foreign clinical trial sites and subjects were in Western Europe, where ethical controls over research are generally as robust as those in the United States.

But the report found that Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. In 2008, the Food and Drug Administration inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited. Mr. Levinson’s investigators found that the F.D.A. was 16 times more likely to audit a domestic site than a foreign one.

Mr. Levinson pointed out that the agency was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing.
.../...

The report “highlights a very frightening and appalling situation,” said Representative Rosa DeLauro, Democrat of Connecticut. “By pursuing clinical trials in foreign countries with lower standards and where F.D.A. lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.” (Ver)

miércoles 30 de septiembre de 2009

Off-shoring en Investigación clínica

martes 24 de febrero de 2009

Investigación clínica:"Off-shoring o externalización global" (II)

O las opiniones de Jesus Acebillo, nuestro "gurú" del off-shoring...

lunes 24 de noviembre de 2008

HUMOR...es lunes: Deslocalización...Jesus Acebillo la llama "off-shoring" o "externalización global" que suena mas bonito...

TAMIFLU: 5 verdades...y una noticia.

1. The manufacturer of the drug sponsored all the trials and the reviewers found evidence of publication and reporting biases. With so much at stake I was surprised that there had been no prospective, placebo-controlled trials conducted that were funded by an independent source. Industry trials can be well conducted, but there are many situations where a lack of independence has had an influence on the way the study was designed and the results that are released. At the very least, it is worth noting that they were probably designed to have the best chance of showing benefit. And that the reviewers had concerned about whether all the information was released. In addition the experts found evidence of reporting bias. According to Tom Jefferson, one of the authors of the Cochrane study: 60% of randomized data from the Tamiflu treatment trials (i.e. in people with influenza-like-illness symptoms) have never been published including the biggest trial ever conducted (which was done in the US, so it’s of great relevance to you).”

2. The studies did not show that Tamiflu reduced the risk of hospitalization. One of the reasons people might take an antiviral is to prevent the illness progressing to the point where they would need to be hospitalized. Unfortunately there was no evidence that the drug produced that benefit.

3. The studies were inadequate to determine the effect of Tamiflu on complications. Even though the drug did not reduce hospitalizations, some people may think it would prevent less severe complications. Unfortunately, the reviewers found that limitations in the design of the trials, their conduct, and the way they were reported precluded any conclusions about the effect of the drug on complications. To expect that Tamiflu can reduce complications would be a leap of faith currently unsupported by the available evidence. You should also know that the FDA requires Roche to print on the label: “Tamiflu has not been shown to prevent such complications [serious bacterial infections].”

4. The studies were inadequate to determine if Tamiflu reduced transmission of the virus. Same story. Some people might prescribe the drug to prevent the spread of the virus. The expert reviewers simply said that with what information they had available; they could not assess the effect of the drug on transmission. I asked Peter Doshi, one of the authors of the Cochrane report about this issue of transmission and here is what he wrote me: “Roche’s prophylaxis trials were not designed to answer the question of transmission. The prophylaxis trials – and FDA approval of Tamiflu for prophylaxis – is based on its proven ability to reduce the chances of symptomatic influenza. (But since we don’t know anything about asymptomatic influenza infections, we cannot say anything about whether or not Tamiflu reduces actual transmission of virus.)”

5. The use of Tamiflu did reduce the duration of symptoms by about a day. The reviewers found 5 studies that assessed the effect of Tamiflu on the duration of symptoms. They were fairly consistent in their findings – though the duration of the symptoms varied quite a lot across the studies. (Más)

Ver

Ver también:

BMJ editor urges Roche to fulfil promise to release Tamiflu trial data. 

Roche esconde.../podría no curar sino matar

AllTrials: De_ROCHE de escepticismo...

Esto publicó Reuters: 

ZURICH (Reuters) - Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data. 

 The company's move follows a decision this month by British rival GlaxoSmithKline to publish detailed clinical study reports as well as the results of all drug trials. 

 Roche has also come under pressure from critics, including non-profit organization The Cochrane Collaboration, to hand over data on its blockbuster flu drug Tamiflu amid claims from researchers that there is little evidence it works. 

 The drugmaker said on Tuesday that it would work with an independent body to evaluate and approve requests to access anonymized patient data and would support the release of full clinical study reports (CSR) via regulatory authorities. 

 "We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," Daniel O'Day, head of Roche's pharmaceuticals unit, said. (Ver) 

De escépticos es no creer...
Zosia Kmietowiicz, en BMJ  es un@ de ellos...

Campaigners for full transparency of all clinical trial data have responded with incredulity to a statement from the drug company Roche saying that it would continue to hold back certain information and results from research into its drugs. 

 Tracey Brown, director of the charity Sense About Science, said that the company was “on another planet.”
.../...
Researchers from the Cochrane Collaboration have been waiting for three years for Roche to honour a promise it made in the BMJ in 2009 to give them access to full results from research on oseltamivir (Tamiflu) to establish the drug’s effectiveness and safety (bmj.com/tamiflu). 

 Last November they rejected an offer from Roche to allow an advisory board to review what type of analysis of data on oseltamivir would be useful to them, saying that they were waiting for the company to fulfil its promise to them. 

 The latest statement from Roche, issued on 26 February, said that the company would continue to vet requests for data that were not publicly available and would allow access only to those it approved. 

 It said that any information that was released through this channel “will be edited in consultation with Roche to ensure patient confidentiality and to protect legitimate commercial interests, including intellectual property rights.” 

 Brown described Roche’s response to the campaign for transparency as “poor,” adding “Which bit of ‘all’ and ‘trials’ do they not understand?” 

 She said, “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Thousands of people are calling for all clinical trials to be registered and the findings published. Patients, researchers, and practitioners are petitioning organisations and regulators for change all over the world. Just today the UK’s Health Research Authority signed up, joining a throng of research organisations, regulators, patient groups, and professional bodies.” (Más)

Ver también:

"AllTrials": working with the public to reform science

ROCHE esconde.../ "podría no curar sino matar" (cont)

Slumdog clinical trials (I)

"nearly 1600 people reportedly
died in India during
“clinical trials of drugs
conducted by various
multinational pharmaceutical companies”
in 2008–10."

Ver

Cases of ethical violations are not new; victims of the 1984 Bhopal gas tragedy were also enrolled—without their knowledge or consent to participation—in clinical trials sponsored by pharmaceutical companies.3 Further, as revealed in 2008, 49 babies died during clinical trials for new drugs at India's premier medical institution over a period of 2·5 years.4 Several published reports, taken together, thus confirm that clinical trials are taking a toll on human life in India and raise some disturbing ethical questions.2—5

Part of the ethical crisis that the clinical trials industry poses to the Indian setting stems from the fact that India lacks effective regulatory mechanisms for oversight of clinical trials. The crisis is worsened by the all-pervasive reality of corruption in India's social institutions, including health care. Questions thus arise about the real efficacy of ethics guidelines and certification of good clinical practice in morally compromised health-care institutions. It is time to acknowledge an ethical crisis in the clinical trials industry in India and to start thinking of creative solutions to tackle this menace.

Ver

Ver también:

Slumdog clinical trials