Friday, February 20, 2015

Tales from the PMCPA contd. - The case of the beer drinking, lederhosen wearing, presenter

​A pulmonologist working in Germany, complained about a scientific symposium organised by Boehringer Ingelheim at the European Respiratory Society (ERS) Congress held in Munich.

The symposium was part of the industry sponsored sessions.  It was advertised in the official meeting programme as ‘Slowing disease progression in IPF [idiopathic pulmonary fibrosis]: New evidence From Phase III clinical trials’.

The complainant stated that his main complaint was that on the main stage, the speakers were allowed to drink beer – with one even dressed in lederhosen.  For a serious, fatal condition, this was not appropriate.  As two of the speakers were from the UK he assumed the UK rules should apply to them.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that the Code applied to the promotion to UK health professionals and administrative staff at international meetings held outside the UK.  Further, that the Code also applied to some non-promotional activities including the use of consultants in Clause 20.  The Panel noted that two of the four speakers at the symposium were UK health professionals and that Boehringer Ingelheim had sponsored UK health professionals to attend the ERS Congress.  The Panel therefore considered that at the very least certain aspects of the arrangements had to comply with the Code.  It was an established principle under the Code that the UK company was responsible for acts and omissions of its overseas affiliates that came within the scope of the Code.

The Panel considered that the involvement of the UK speakers meant that Boehringer Ingelheim was responsible under the Code for the arrangements for the UK speakers including their travel and subsistence and the impression created by these.

The Panel noted that one of the speakers appeared to be drinking beer on stage during the satellite symposium.  The Panel considered that the overall impression given was unacceptable.  The subsistence in this regard was inappropriate.  The Panel considered that high standards had not been maintained.  A breach was ruled.

Tuesday, February 10, 2015

Last Week Tonight with John Oliver: Marketing to Doctors (HBO)

Friday, January 30, 2015

Mother brought to tears hearing Johnson & Johnson's Risperdal tactics


David Sell
Posted: Friday, January 30, 2015, 8:05 AM

Benita Pledger dabbed at her tears as she sat in a wooden chair outside a court room in Philadelphia's City Hall early Thursday evening.

"I'm just having a hard time right now," she said, "hearing what the pharmaceutical company was doing."

Pledger had just finished a full day of listening to her attorney, Thomas Kline, and former U.S. Food and Drug Administration commissioner Dr. David Kessler discuss documents that showed Johnson & Johnson's Janssen Pharmaceutical subsidiary tried to manipulated data in versions of reports to hide evidence that the company's antipsychotic drug Risperdal had caused boys like her son to grow breasts.

"The most important thing for me, as someone who worked for the FDA, as a physician and as somebody who served on the boards of pharmaceutical companies, is you tell the truth and you tell the whole truth," Kessler said on the stand. "You tell the whole story. You make sure the data supports the message. What they want to convey doesn’t match what the data shows and to me, that doesn’t tell the whole story. Make sure the FDA knows and make sure the doctors know. Tell them the good and the bad."

Pledger and her husband sued J&J in Philadelphia's Court of Common Pleas, alleging that Risperdal caused their son to grow breasts, a condition called gynecomastia. Judge Ramy Djerassi is presiding over the trial, which might run four weeks.

Kline and Kessler focused Thursday on a 2001 study conducted by Janssen that showed some children (under 12) and adolescents (12 and older), who were already taking Risperdal, had higher-than-normal incidence of gynecomastia. Company emails and drafts of manuscripts being prepared for publication, which were shown in court Thursday, indicate an effort to re-analyze data so as to downplay the prevalence of gynecomastia.

"Janssen appropriately analyzed and reported data from clinical trials," Janssen spokeswoman Robyn Reed Frenze said in a statement. "Risperdal continues to help countless children and adults around the world who suffer from the debilitating effects of schizophrenia, bipolar mania and irritability associated with autistic order in children.

Risperdal was originally approved in 1993 only to treat psychotic disorders in adults. "On March 3, 2002, the approved use was narrowed to treatment of schizophrenia only," phrasing used by the Justice Department in 2013 in its statement after J&J agreed to pay $2.2 billion for settle one criminal charge and other allegations that it illegally promoted Risperdal for unapproved uses.

Doctors are allowed to prescribe medicine as they see fit, including "off-label," meaning for conditions not approved by the FDA and on the official label. Drug companies are not supposed to promote drugs for illnesses or for a group of patients for whom the drug is not approved and not on the label. But the squishiness of definitions of mental illness opens the door even wider for drug companies do such promotion.

Pledger's son is severely autistic. He is 20 now. He was eight when she filled the first prescription in August 2002 at Walmart near the family's home in Alabama. Benita Pledger was reluctant to try medicine when the subject was first raised by her son's pediatric neurologist, but her son's behavior problems, the melt-downs at home and school, prompted her to eventually try Risperdal. He used it until April 2007.

Risperdal was not FDA approved for use in children for any illness until 2006, so officially Janssen could not promote the use of the drug in children. But Jan Mathisen, the pediatric neurologist for Pledger's son, testified Monday that a Janssen sales rep came to his office 20 times between 2002 and 2004. He said he knew he was the most frequent prescriber of the drug in the state. But he also wanted samples for his patients, especially those with challenging financial circumstances. In her 2012 deposition, Benita Pledger said her husband was a self-employed mechanic and the family had no health insurance. She heard about gynecomastia on TV. When the J&J attorney asked in deposition if she had explored Risperdal on the Internet before suing, Benita Pledger said the family had no Internet access.

One of the challenges with many drug candidates for children is that parents are reluctant to have a drug tested on their children. It is perhaps telling that in 2001, when Janssen was pushing for approval to expand the approved uses on its existing official label and sell Risperdal for use in autistic children, it had plenty of children to use in clinical trials to answer FDA questions.

Prolactin is a hormone produced by the pituitary gland and is normally present in low amounts in men and non-pregnant women. Prolactin's primary role is to promote lactation.

Kline and Kessler focused on a Janssen study that showed higher prolactin levels and incidence of gynecomastia, especially in boys but also in a few girls taking Risperdal. They went through emails, company plans, changes to plans and multiple versions of a manuscript the company hoped would be published in a peer review journal to help its case with the FDA.

Kessler testified that based on the documents, Janssen appeared to have changed how it grouped patients in the one study and then merged the data with other studies to report a less significant potential risk.

"You certainly don’t want to change your plan after you know your results,” Kessler said.

J&J's attorney, Diane Sullivan, who declined comment after court Thursday, fought all week to keep the emails, documents and draft manuscripts from being submitted as evidence, shown to the jury and used as a basis for questioning of Kessler. Trying again Thursday, she said drug companies can't unilaterally change the label on a drug, that the label and any warnings must be decided in conjunction with the FDA.

Technically that is correct, Kessler said, but not in reality.

"A manufacturer can always warn about a safety issue and should warn about a safety issue," Kessler said. "There is nothing in the federal register that prevents a manufacturer from warning about a safety problem and there are many different ways. If somebody is sending a sales rep into a doctor's office, into a pediatric neurologist's office and doing it multiple times, you have an obligation to provide adequate direction. If you have information on a safety issue, you have to communicate that. Tell the good. Tell the bad."

Kessler is scheduled to resume testifying Friday.

http://www.philly.com/philly/business/Mother-brought-to-tears-hearing-Johnson--Johnsons-Risperdal-tactics---.html

Thursday, January 29, 2015

NNT - The Website

http://www.thennt.com

Thursday, January 22, 2015

Maurice Saatchi's Medical Innovation Bill is more likely to make its proposer money than it is to help anyone who's sick.

Maurice Saatchi, his Medical Innovation Bill, and the booming ‘orphan drugs’ market

Wikimedia

Maurice Saatchi has had a great deal of media attention lately. This has focused for the most part on his Medical Innovation Bill (also known as the Saatchi Bill), which he has campaigned for in the wake of his wife's death from cancer back in 2011, and which will have its 3rd Reading in the House of Lords on Friday (23rd January). But Lord Saatchi is also, of course, a very astute and successful businessman.

2013 was a good year for M&C Saatchi Plc, of which Maurice Saatchi is a director and shareholder. CEO David Kershaw attributed the company’s 5.2% rise in revenues in part to “getting back into pharma" with clients such as Reckitt Benckiser and Bristol-Myers Squibb’. Swiss pharmaceuticals giant Novartis is also a Saatchi client, and boasts "one of the industry's largest and most robust oncology pipelines". Medical Marketing & Media predicts that Bristol Myers Squibb will be the world’s biggest orphan drug company by 2020.

The term ‘orphan drug’ refers to a drug developed for the treatment of a rare medical condition. Once the poor relation of the pharmaceutical industry, orphan drugs are now big business. Sales are expected to grow 11% per year and the market is predicted to reach US $176 billion by 2020. The anticipated return on investment is almost twice that of non-orphan drugs.

An article in industry newsletter Fierce Pharma reports that "As many drug makers have figured out, a small patient group can prove extraordinarily lucrative." In 2014, the average orphan drug cost per patient per year was $137,782 compared to an average of $20,875 for a non-orphan drug. 

In the same week that Saatchi’s Medical Innovation Bill reached Committee Stage in the House of Lordsa conference on orphan drugs was held at London's Regent’s Park Holiday Inn, with one of the main attractions an "interactive roundtable discussion" with Dominic Nutt, director of the Saatchi Bill’s PR campaign.

The conference brought together "leading experts and companies such as Novabiotics, Pfizer, AstraZeneca, GMP Orphan SAS, Genethon and M&C Saatchi and many more to discuss the latest developments in the market.” It was billed as "suitable for attendees wanting to enhance development pathways with the growth of the commercial pipeline for orphan drugs and rare diseases, to access tools for consideration to gain early market access and enhance patient recruitment…”

Money Week considers the very prospect of Saatchi’s Medical Innovation Bill a boon to the biotech industry. Of course, the NHS provides a large ‘market’ with a vast number of patients for ‘recruitment’, but what is it about the bill that is so exciting to pharmaceutical companies and the biotech industry in general?

Demonstrating to a reasonable level of certainty that a drug is safe and effective takes time and money. And there is financial risk for investors: the drug may turn out to be not much use or actively dangerous.

The Saatchi Bill is designed to prevent doctors being sued for negligence if they give an experimental treatment (though not for purposes of research: this is expressly forbidden). They gain this protection even if no other doctor would support that treatment, so long as they have ‘obtain[ed] the views of one other doctor’ – who doesn’t have to agree. (What’s more, that one other doctor can be a business partner in a private practice, or a doctor who supplements his income with paid consultancy work for pharmaceutical companies.)

Let’s look at ‘negligence’ in the context of current medical law. Nigel Poole QC, a clinical negligence lawyer with Kings Chambers explains: "A doctor is negligent if he acts in a way which no responsible body of medical opinion would support or which has no rational basis. … A patient can only sue a doctor in negligence if they suffered avoidable harm as a result of his or her treatment. The patient’s family can sue if the negligent treatment caused the patient’s death. … Responsible doctors who are not negligent [as defined above] or who do not harm or kill their patients do not need protecting. … The [Medical Innovation] Bill protects doctors who act in a way which no responsible body of medical opinion would support and as a result harm or kill the patient they have treated." Sir Robert Francis QC, who chaired the Mid-Staffs inquiries, concurs in his damning response to the bill: “It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion.”

So with the Saatchi Bill, the need to demonstrate safety and effectiveness is greatly reduced. Doctors can try experimental treatments that have no evidence to support them, the pharmaceutical companies can supply the drugs, and the risk is borne entirely by the patient. “Alarmingly non-specific in its wording, the Bill opens up several potential means of causing harm to patients without recourse to protective legislation," according to an editorial in The Lancet Oncology.

The Medical Innovation Bill’s stated aim is "to encourage responsible innovation in medical treatment." Does it address a lack of funding for research? A lack of resources within the NHS for new treatments? The bureaucracy surrounding regulation of new treatments, or the professional regulation of doctors? No. None of these. Not in any way, shape, or form. Maurice Saatchi has decided that a fear of litigation is the problem.

The Medical Defence Union and the Medical Protection Society have stated clearly that they do not believe doctors are prevented from innovating by a fear of litigation. The British Medical Association and the Royal Medical Colleges don’t think so either. They do not support the bill; neither does the NHS Litigation Authority or the Medical Research Council. No one has been able to find a single case where a doctor has been sued for innovating. Even Harry Woolf, a supporter of the Bill and a former Lord Chief Justice, cannot cite a single such case.

And yet, as its sole contribution to medical innovation, the Saatchi Bill blandly states: "It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly." In current law, negligence means falling below a minimum standard of competence. It has nothing to do with a decision to depart from accepted practice, however that might be defined – there is no central register of accepted treatments, as Nigel Poole QC has pointed out. But under the Saatchi Bill, provided the doctor follows a few ill-defined procedures prior to giving the treatment, s/he cannot later be sued no matter how devastating the harm suffered by the patient as a consequence of that treatment.

Most patients condemned to death by a dreadful disease – and those who make decisions on their behalf – are willing to try anything, anything at all to prolong their lives. Under existing law doctors already can and do provide innovative treatments, including orphan drugs both trialled and un-trialled, when it is reasonable to think the treatment is in the best interests of the patient; existing law protects both doctors and their patients. The Ebola patients recently and currently being treated on the NHS are a good example of this.

The Lancet Oncology editorial cited above states "doctors are already able to innovate outside the context of trials." Particularly in oncology and paediatrics, drugs are often used ‘off-label’ (i.e. for a patient group or condition for which the drug has not been trialled). And in fact, proper monitoring, reporting, and appraisal of off-label use can provide valuable insights for future use. He states further that ‘there are many ways in which doctors can access drugs that are in early-stage clinical trials but not yet widely available.” (ibid)

All the Saatchi Bill does is to remove existing protection from patients when the doctor gives a treatment no colleague would support. According to Dr Marika Davies, a medico-legal adviser at the Medical Protection Society said, it “will put patients who are desperate to try anything at risk of harm from unsuccessful, ineffective and possibly harmful treatments.” The Editorial in the Lancet Oncology cited above offers an example, “the provision of [unlicensed drugs] on a desperate whim, in an unmonitored environment, could lead to patient harm. … Even if the drug had advanced to later testing, but is not yet licensed, pharmaceutical companies would be required to disclose data about toxicities to national licensing agencies only. This information may not stop pharmaceutical companies from promoting their treatment to medical professionals. Doctors could end up prescribing drugs that hurt their patients, only to find later that the toxicities were known, but undisclosed. Clearly this would cause preventable harm to patients; it could also cause ‘immeasurable psychological pain for doctors who believed they were providing the best care for their patients’ ibid Pharmaceutical companies have been known to fall short of ethical practice in promoting their drugs to doctors. Novartis, for example, was involved in two scandals in Japan alone last year, one of them for failing to disclose known side effects of leukemia drugs.

Innovation is a word with very positive connotations, but “the history of medicine is littered with good intentions and innovations that seemed like a good idea but turned out to have disastrous side effects” - as Conservative MP Dr Sarah Wollaston, a former GP, pointed out in an Adjournment Debate on the bill in the House of Commons last month. She also pointed out that the extraordinary developments in medicine over the last 40 years have been thanks to clinical trials establishing efficacy and risks.

The Medical Research Council, the Academy of Medical Sciences, the Association of Medical Research Charities, the Motor Neurone Disease Association, Parkinsons UK, the British Heart Foundation, Leukemia and Lymphoma Research and the Wellcome Trust, among others, have pointed out that the Bill may inhibit genuine medical innovation as it could discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, thereby producing unlinked anecdotal evidence that is virtually useless. Dr Sarah Wollaston describes as a "fundamental flaw" the fact that the Bill "specifically precludes the treatments being linked in any way, so we will learn nothing from these treatments. Lord Saatchi’s premise is that his Bill will advance medical knowledge, but there is no evidence that it will advance medical knowledge an inch because we will not be able to answer that fundamental question about whether there are unintended harms from the treatments or any long-term benefits." She goes on to say, ‘If the Bill is passed and undermines enrolment in clinical trials, we will be doing a grave disservice to medical innovation, and it will be to our great shame to have done so.’ (ibid)

If the Medical Innovation Bill is enshrined in law, the incentive for pharmaceutical companies to develop their products beyond the experimental stage all but vanishes. With the Saatchi Bill, they can make a return on investment without the need to progress to clinical trials or market authorisation. And without clinical trials, the opportunity to advance the development of effective treatments is lost.

Current law is flexible and innovative practice by individual doctors is expressly permitted where reasonable. Current law does not undermine clinical trials, within which doctors work collectively to produce innovations of great value to patients. Current law protects both patients and doctors and promotes responsible, ethical medical practice.

A vast number of medical professionals and eminent lawyers, along with respected charities and patient advocacy groups oppose Lord Saatchi’s Medical Innovation Bill on the grounds that it is both dangerous and unnecessary. A handful of quotes below indicates the strength of the opposition the Bill’s supporters ignore:

 “If there is misunderstanding [regarding the protection offered by current law] then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risk and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done.” 

Sir Robert Francis QC

 ‘We are dismayed that the bill is being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer. … We are concerned that rather than promoting responsible scientific innovation in the treatment of cancer, the Medical Innovation Bill will actually encourage irresponsible experimentation producing nothing more than anecdotal ‘evidence’, at the potential expense of causing serious harm and suffering to patients, their families and carers.’ 

Letter from 100 oncologists to The Times 13th November 2014

 ‘[The Medical Innovation Bill] is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patients’ safety but medical innovation…’

Dr Sarah Wollaston MP ibid 

“I conclude with the words of Michael Baum, one of the leading innovative surgeons in cancer in this country, whose contribution to breast cancer is second to none. He has said to me that in his view, “Their Lordships are walking over a precipice if they pass this Bill”. We have to listen to that very carefully.”

Lord Robert Winston

The Lancet Oncology’s opinion is this Bill should never be enshrined in law.” 

If neither patients nor doctors nor medical science nor British law are well served by this bill, what purpose does it serve? Who benefits from it? M&C Saatchi Plc had another very good year in 2014 and the noble Lord and his team are "looking forward to the Third Reading of the Medical Innovation Bill this Friday in the House of Lords."

I have looked through Hansard and other relevant documents to see if Maurice Saatchi has declared a financial interest in his Medical Innovation Bill. I’ve found no evidence that he has done so.

The British public are entitled to full, clear, and accurate information about this bill, not the smoke and mirrors of a PR campaign.

https://www.opendemocracy.net/ourkingdom/anne-williams/maurice-saatchi-his-medical-innovation-bill-and-booming-‘orphan-drugs’-mark?

Monday, January 19, 2015

NICE - what's hot in 2015

The Medicines and Prescribing Centre at NICE has published the 2015 update to Key therapeutic topics - Medicines management options for local implementation (PDF).

This publication summarises key therapeutic areas where there are potential opportunities for maintaining or improving quality and improving value.

This update has retained the previous 14 therapeutic topics. All the topics have been reviewed and updated in the light of new guidance and important new evidence. Changes include:

KTT2: Renin-angiotensin system drugs. The addition of a table summarising NICE recommendations on the use of renin-angiotensin system drugs in various indications
KTT3: Lipid-modifying drugs. Updated to reflect recommendations in the NICE guideline on lipid modification, published in July 2014
KTT4: Omega 3 fatty acid supplements. Updated to reflect recommendations in the NICE guideline on MI – secondary prevention, published in November 2013 and the NICE guideline on lipid modification, published in July 2014
KTT9: Antibiotic prescribing – especially broad spectrum antibiotics. Updated in line with Public Health England guidance on managing common infections, which was updated in November 2014
KTT10: Three-day courses of antibiotics for uncomplicated urinary tract infection. Updated in line with Public Health England guidance on managing common infections, which was updated in November 2014

http://www.prescriber.org.uk/2015/01/key-therapeutic-topics-2015/

Saturday, January 10, 2015

Daiichi Sankyo Inc. Agrees to Pay $39 Million to Settle Kickback Allegations Under the False Claims Act

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, January 9, 2015

Daiichi Sankyo Inc., a global pharmaceutical company with its U.S. headquarters in New Jersey, has agreed to pay the United States and state Medicaid programs $39 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce physicians to prescribe Daiichi drugs, including Azor, Benicar, Tribenzor and Welchol, the Justice Department announced today.

“The Anti-Kickback Statute prohibits payments intended to influence a physician’s ordering or prescribing decisions,” said Acting Assistant Attorney General Joyce R. Branda for the Civil Division.  “The Department of Justice is committed to preserving the independence and objectivity of those decisions, which are cornerstones of our public health programs.”

The Anti-Kickback Statute was enacted to ensure that physicians’ medical judgment is not compromised by improper payments and gifts by other health care providers.  The statute generally prohibits anyone from offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by federal health care programs, including Medicare and Medicaid.

In this case, the government alleged that Daiichi paid physicians improper kickbacks in the form of speaker fees as part of Daiichi’s Physician Organization and Discussion programs, known as “PODs,” which were run from Jan. 1, 2005, through March 31, 2011, as well as other speaker programs that were run from Jan. 1, 2004, through Feb. 4, 2011.  Allegedly, payments were made to physicians even when physician participants in PODs took turns “speaking” on duplicative topics over Daiichi-paid dinners, the recipient spoke only to members of his or her own staff in his or her own office, or the associated dinner was so lavish that its cost exceeded Daiichi’s own internal cost limitation of $140 per person.

“Drug companies are prohibited from using lavish entertainment and padded speaker program payments to induce physicians to prescribe their drugs for beneficiaries of federal health care programs,” said U.S. Attorney Carmen Ortiz for the District of Massachusetts.  “Settlements like this one show that the government will continue to pursue health care companies that use kickbacks to promote their products.”

As part of the settlement, Daiichi has agreed to enter into a corporate integrity agreement with the Department of Health and Human Services-Office of Inspector General (HHS-OIG), which obligates the defendants to undertake substantial internal compliance reforms for the next five years.

“Schemes such as this are particularly abhorrent,” said Inspector General Daniel R. Levinson for the U.S. Department of Health and Human Services.  “Manufacturers and physicians who engage in them are cheating Medicare and Medicaid out of millions of dollars and threatening programs upon which many elderly and disabled Americans rely.  My office will take whatever steps necessary to guard against improper alliances between manufacturers of drugs and those who prescribe them.  Through our corporate integrity agreement we will be closely monitoring Daiichi.”

The settlement announced today stems from a complaint filed by Kathy Fragoules, a former Daiichi sales representative, under the whistleblower provisions of the False Claims Act, which authorize private parties to sue on behalf of the United States, and to receive a portion of any recovery.  Fragoules will receive $6.1 million of the federal recovery.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $23.3 billion through False Claims Act cases, with more than $14.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The investigation and litigation was conducted by the Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, the U.S. Department of Veterans Affairs, the Department of Defense Criminal Investigative Service, HHS-OIG and the FBI.  The claims settled by this agreement are allegations only and there has been no determination of liability.

The case is captioned U.S. ex rel. Fragoules v. Daiichi Sankyo, Inc., Civil Action No. 10-10420 (D. Mass.).

http://www.justice.gov/opa/pr/daiichi-sankyo-inc-agrees-pay-39-million-settle-kickback-allegations-under-false-claims-act

Thursday, December 18, 2014

A letter from PharmedOut

Dear Friends of PharmedOut,

 

Happy Holidays! We hope you saw Pharmed Out quoted in the New York Times last week. We are excited to tell you about our newest vision for PharmedOut in 2015 and beyond, and how you can help.

 

As many of you have noted, silently or vocally, our website and social media presence need an update. Students who recently critiqued our website were, well, kind:

 

“… the PharmedOut website is awesome…However… the website needs to be updated.”

 

“…The website feels dated.”

 

“I believe in what PharmedOut stands for and I think it is essential… However, the website does not succeed in conveying the mission of PharmedOut.”

 

The good news: PharmedOut is an important resource for healthcare providers and educators.

The bad news: PharmedOut’s website is stuck in the 20th century.

 

We are committed to redesigning and revamping our website and enhancing our social media presence before our upcoming conference, on June 11-12, 2015 – Put it on your calendar! It’s going to be great. Carolyn Clancy, MD, former director of the Agency for Healthcare Research and Quality, will be our keynote speaker. Planned topics include the soaring costs of generic and brand-name drugs, polypharmacy in geriatrics and palliative care, diagnostic expansion in the Diagnostic and Statistical Manual, overuse of opiates, how pharmaceutical companies manipulate medical journals, and the intimidation of researchers by industry.  

 

PharmedOut conferences are famous for unique talks, fabulous presenters, amazing networking, and good food. Still, we were surprised at the collective howl of anguish that arose from prior attendees when we decided to skip having a conference in 2014. We’re committed holding a conference this June, but this year’s conference will be entirely funded only by contributions and registration fees. We need to raise $25,000 to fund the conference and the overhaul of our website.

 

Please consider making as large a donation as you can so that we can have a great conference and expand the impact of our project by bringing it into the 21stcentury!

 

 

All the best,

 

Adriane Fugh-Berman MD and Alessandra Hirsch MS

Ben Goldacre writes

Dear Friends

Please help us make a real and lasting change.

Two years ago I started discussing the problem of withheld trial data with Sense About Science. Back then, the situation seemed hopeless, and I was angry: many institutions were in denial, and many past efforts to fix the problem had ground to a halt. In January 2013 Sense About Science formally took this issue on as a core campaign, and with others we started the AllTrials campaign. Since then, progress has been phenomenal. WHO, the European Commission and the US, UK and Canadian Governments have finally been persuaded to take further action. Hundreds of organisations have agreed to help, including the great and good of the medical establishment. Eighty patient groups signed up in one day. We have seen lots of new promises, and many of them are credible and formal.

The future of clinical trials reporting is going to be different. But that’s not enough.

Doctors don’t only use medicines invented after 2014: we use treatments that came on the market five, ten, twenty years ago, and more. All of this information is vital, but much of it is still being withheld. Getting access to these trials - on the medicines we actually use today - is much more important than changing reporting standards for new drugs, and could have a huge impact on medicine.  

This means we need action. We know the companies and organisations which hold this information. At the moment, there are huge differences between them: some still defend secrecy, or claim that sharing is impossible; while others have exposed that claim, by taking significant steps towards greater transparency. Many are staying silent. We think they are hoping that the AllTrials momentum will fizzle out.

That's not going to happen. In the New Year, Síle Lane and I will be banging on the doors of individual pharma companies to ask them what they’re doing to fix this problem. And we will be announcing some very interesting new projects and tools.

All this progress has only been possible because you have been involved. We built an organised and coordinated campaign, with doctors, academics, publishers and tens of thousands of patients working alongside experienced full-time campaigners. We all have been able to turn decades of grumbling into decisive, targeted action.

But the campaign needs money to be sustainable. In the past two years many of you have donated to AllTrials. You have given generously, and we’ve reached half our initial target: that’s how we got this far. Now we need to find the other half. If 80% of you gave just 10 pounds, dollars or Euros each, we can keep going. The campaign team will be able to insist on meetings with companies, and know that we can afford to pay the fares. We can keep up the coordinated campaign.https://ssl.gstatic.com/ui/v1/icons/mail/images/cleardot.gif

If you can give this amount, or if you can give anything at all, please donate here:

https://www.justgiving.com/alltrials

If you can’t, we’ll continue to value the help and support you give in other ways, and we know that you will spread the word (especially to your richest friends…). Together, we will reverse the waste and injustice of unreported clinical trials, and make medicine better.

Ben



Wednesday, December 17, 2014

Wednesday, November 26, 2014

Write a message to the NIH

Dear Friends

Last month, many of you supported the WHO’s plan to call for the results of all clinical trials to be reported. Now we all need to support proposals from the US Government to improve clinical trial transparency there.

The US Department of Health and Human Services (HHS) and National Institutes of Health (NIH) have announced proposals to expand requirements to register clinical trials and report results, and to make that a condition of research funding. This is a significant and potentially transformative step in the battle for clinical trial transparency.

Francis Collins, Director of NIH, said, “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health.” Read more about the proposals and comments from Ben Goldacre and other AllTrials supporters here.

We have to make sure HHS and NIH don’t water down these strong proposals.

  1. Tell HHS that you support it expanding the law so that more trials have to be registered and reported.
  2. Email clinicaltrials.disseminationpolicy@mail.nih.gov to tell NIH that you support it requiring all the trials it funds to be registered and to report results.

Both consultations run until 19th February 2015 and are open to everyone, not just US citizens. We are working on our responses now and will share them with you soon.

Best

 

Ian

--

Ian Bushfield
Campaigns Support Officer
Sense About Science: Science and evidence in the hands of the public

AllTrials:  Web | Twitter | Facebook


Tuesday, November 18, 2014

Sunday, November 16, 2014

Wednesday, November 05, 2014

Wednesday, October 22, 2014

Ben Goldacre: Pharma industry has destroyed its own reputation


Ben Goldacre
Ben Goldacre [Scott Hurst/Flickr]

EXCLUSIVE: The great tragedy for the pharmaceutical industry is that it keeps denying that it lobbies against transparency in clinical trials, says Ben Goldacre.

Ben Goldacre is a British physician, academic and author of the best-selling books Bad Science and Bad Pharma. He spoke to EurActiv's editor and publisher Frédéric Simon at the sidelines of the conference Transparency and public health - how accessible is scientific data?

What do you think of the EU’s clinical trials regulation for example in terms of transparency?

Well, I think the regulation is positive in many respects and it feels unkind to talk about its shortcomings when it was so hard won. Even that is progress. But the fact remains, it does not deliver all the methods and results of clinical trials, of all the uses, of all the treatments which are currently being prescribed by doctors.

You’re referring about the historical data issue?

It’s historical data, but it also does nothing to improve access to methods and results of clinical trials on uses outside of the marketing authorisation of a drug. Even though we know that drugs are very commonly and very sensibly prescribed outside of their marketing authorisation; out there in the real world, of doctors’ practices for patients across the whole of Europe, and the world. So it has several important shortcomings.

Lastly, I think there are very serious concerns around how all of these new changes are going to be implemented by EMA (the European Medicines Agency), because we know that they are going to be redacting clinical study reports on various different grounds such as commercial confidentiality and patient confidentiality.

Now that is reasonable in principle and the devil will be in the detail. Unfortunately, the only prior example we have to go on is what happened with AbbVie. In this case, even protocol changes had been censored from the clinical study reports on their drug Humira. It’s very widely used.

I cannot see how that can be commercially confidential information; a change in a protocol. But I can see that a change of a protocol is very important for any doctor or researcher trying to interpret the results of a clinical trial, because who knows what has happened with these protocol changes? Protocol changes can sometimes be done because somebody doesn’t like the way a trial is going. Perhaps they switch the way they are measuring an end point. Who knows what’s in there?

As a basic principle, protocol changes is something which doctors and researchers need to be able to see on any trial in order to understand what was done.  In order to understand whether it was a fair test of the treatment or not. So from the very first example we have had about how EMA had dealt with actions, there are good grounds for concern.

I think there are also grounds for concern in the secret meetings that we know now the industry has had with the EMA. We have to accept that lobbyists… It’s an ugly truth. They will have meetings with elected politicians. But for a statutory body like EMA, I think it’s very concerning to hear that they have had meetings which are un-minted and inaccessible. We can’t know what was discussed.

The meetings that took place about the pro-active transparency policy?

This is correct. The ones that have been complained about by Jim Murray (EU health blogger and former director general of the European Consumers’ Organisation) in his latest complaint to the EU Ombudsman.

There’s a mention in the new clinical trials regulation which says that clinical trial information can be withdrawn from reports if they can be considered as commercially sensitive. We did hear today though at the conference that the concept of commercially-sensitive information is pretty vague. How much of a concern is this to you?

I think it would be naïve to imagine that if the Parliament was to give a clear definition of what commercially confidential information then that would suddenly resolve all the disputes. I think it would open up a whole new raft of legal arguments, but I think it would at least be a step forward.

So I think it’s problematic that there’s not a clear definition of that. I have to be clear: there are many commercial aspects of a drug have absolute no interest for doctors, researchers or patients. It’s boring, banal and nobody cares.

However, sometimes people try to say that if a competitor has applied for information about clinical trials that must by definition be the kind of commercial activity that we should automatically regard as unacceptable.

I think that that’s mistaken, because sometimes the people who are in best place to spot shortcomings in your trial design, or perhaps even risk signals in your data, are your competitors. They are best placed because they have the same academic skills set that you have so they are able to spot methodological shortcomings or risk signals in data. They are also highly motivated to spot those adverse signals.

But that’s not going to happen…

That’s not commercially confidential information. That’s absolutely fine. Some people say that they are very angry that drug companies have applied for other drug companies’ clinical study reports. I say “well, fine”. Very often drug companies spot or give a platform to concerns about side effects of their competitors’ drugs. That is perfectly acceptable within their rich ecosystem of public discussion.

They would probably have an interest in not doing that publically?

I think if a motivated and capable group of people are interested in spotting risk signals of side effects in another company’s information then that sounds like a very sensible use of everybody’s time. The whole point of science is about replication and reviewing it. It’s about showing your're working.

Unfortunately, we live in a world in which people are able to obfuscate the shortcomings of their trial design. They are able to obfuscate signals of harm from their drug. They do that for commercial reasons.

If you are asking me to suddenly feel upset that now there’s going to be a group of people who for commercial reasons are going to be enabled to help spot those risk signals which others have sought to hide, I would say that sounds fine to me. It’s a very different category of competitive commercial use of data to the things we can all agree on are unacceptable, like, for example, downloading one company’s clinical study report and then going to a developing country and getting a marketing authorisation for the same molecule. That is obviously unacceptable. And it’s very straightforward to put legal framework in place to stop that happening.

Similarly, I don’t think that we need to share any information in the discussion between a company and a regulator necessarily where they are saying “We’re thinking about applying for a marketing authorisation on x or y”, but if there’s clinical trials data that is germane to that commercial decision, then that trial data is also germane to treatment decisions being made by doctors and patients. So that should be made available.

A company’s commercial interest, I have absolutely no interest in. A company’s manufacturing methods, I have no interest in. But methods and results of clinical trials must always be in the public domain.

A number of concerns were being raised today at the conference about the ongoing EU-US free-trade negotiations. Do you think it’s going to shape heavily the way that clinical trials transparency is being done in the future ,or are we sort of safe now that there is a regulation in place?

No, no, quite the contrary. I think the big risk here is that bear traps will be laid in the woods so that there will be catchall phraseology used in TTIP. I can certainly envisage a situation where these bear traps will be laid with apparently neutral wording that will seem sensible and then that will be used as the foundation of subsequent derailment of positive developments within the clinical trials regulation.

So, yes, I think it’s a real threat and I think it’s an interesting example. I think there’s inequality of arms. Every word in a document like that has been thought over and in many cases by a large number of motivated, highly-educated individuals who can see significance in every word. Losers like me are not as capable at either being heard or analysing risks of the wordings of those documents.

What do you make of the argument of personal data privacy?

I wouldn’t like to say anything about any individuals, but it is increasingly clear to me that this is being used as a deliberate rhetorical tactic to derail a serious discussion around how to share individual patient data, and it is remarkable not just here but everywhere to see organisations, which report to patients, that as soon as trials transparency is mentioned, there’s no serious discussion of the mechanics of how we can positively work towards delivering it. There’s no serious detailed discussion of the huge benefits, especially for people with orphan diseases. It leads immediately to this idea that patients can be re-identified. That is of course a risk, but it’s a risk we have been managing in the world of epidemiology for generations now.

Nobody is suggesting that medical records should be posted openly on the Internet. Everybody is very clear that you need to have an application process. You have to demonstrate that you are a serious researcher with a serious question. You have to ensure that patient privacy is protected. When you see people repeatedly raising this, apparently not having heard the reassurance that came earlier in the conversation, to me that looks like it's strategic, rhetorical derailment rather than a serious attempt to engage in a discussion.

It’s very worrying to see that coming from patient groups, especially when we have already seen the leaked memo from pharma and EFPIA in which they talked under the heading advocacy strategy of how they would in their words “mobilise patient groups” to raise concerns about privacy.

I think there are a lot of people with good intentions in industry and some people with not so good intentions of course. But one thing I find very disappointing is when people imagine that they can get away with being disingenuous in public. I find it tiresome that people would say “We haven’t lobbied against transparency” when it’s clearly true. It just doesn’t seem to me that it gets us anywhere.

It’s hard to have respect for people who do that. I’m not even sure it achieves what they hope. It just looks incredibly bad. It’s the great tragedy of this whole area. The pharmaceutical industry makes products that save lives on a biblical scale. There’s this huge prize of public gratitude that is waiting to be claimed by them and they managed to shoot it all away with this incredibly seedy behavior by paying patient groups, by cover secret behavior and suing regulators to hide information.

I don’t think the benefits of that behavior are as great as the downsides. The downsides are a long game and they are collective for the whole industry. For an individual company it may seem attractive in the very short term to behave as badly as you can get away with by the letter of the law, but I think in the bigger picture, they have destroyed the reputation of the industry in which should be one of our most prized. They should be up there with teachers. It’s just extraordinary that they have managed to do that. It’s extraordinary that they have managed to do it before your very eye.

Turning to the EMA and its role as a regulator, are they not in an awkward position asking for documents to be handed over to them, but also running the risk of being sued? What is your feeling about the agency’s role generally and its job as a regulator?

I think it’s very interesting how everybody is stepping up and becoming critical of EMA. I think that makes things very uncomfortable for them. I think big and well-paid organised lobbying organisations can do a better, slicker job of talking in a very collegial fashion about their colleagues in the regulatory profession and be lovely to and about them while encouraging them to do what they want.

I’ll just say that it’s not good enough what they are doing. To an extent I think we should remember that EMA in particular over the past few years, after Guido Rasi has taken over, has made enormous leaps forward and very clearly against the hailstorm of anti-transparency lobbying from industry which they have ridiculously denied.

As a regulator, you are paid to be in that mediating position of dealing with people with conflicting demands. All I would say is that frameworks and principles have to put have to put public health first. Especially when it’s absolutely clear that transparency doesn’t conflict with commercial success. Nothing that I ask for undermines a company’s ability to make money.  

http://www.euractiv.com/sections/health-consumers/ben-goldacre-pharma-industry-has-destroyed-its-own-reputation-309355?