Latest Drugwonks' Blog
Jamie and the Love-ites are on a quest to co-opt the debate over the growing problem of non-communicable diseases in the developing world to further their own anti-IP agenda.
Consider this new article from Intellectual Property Watch (Note – all bolded portions have been so noted by me):
Non-communicable diseases such as cancer and diabetes now have a global reach, and are the leading cause of death, according to the World Health Organization, which describes them as an “epidemic.” Once considered problems of rich countries, they now hit low- and middle-income populations the worst, says WHO, but preventive actions could be taken. Meanwhile, civil society is warning about the lack of availability of medications to treat non-communicable diseases in developing countries.
In the battle of rhetoric, the anti-IP community has co-opted the term “civil society” for themselves. Don’t be fooled by the Mahatma-sounding moniker.
In an effort to address this, WHO will launch its Global Status Report on Non-Communicable Diseases (NCDs) tomorrow, at its first global forum on the subject, being held in Moscow on 27 April.
The global forum brings together stakeholders to “share views and experiences to date on the challenges and opportunities” in NCDs, in particular for their prevention, treatment and control.
One of the objectives of the forum is to understand expectations, roles and contributions of different stakeholders in support of the September 2011 United Nations High-Level Meeting on NCDs. Another objective is to mobilise a “broader base of stakeholders in support of NCD prevention and control, in particular in developing countries,” WHO said.
And “stakeholders,” in case you were wondering, does not mean the pharmaceutical industry.
Following the global forum, the WHO is holding a first Global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control, co-organised with the Russian Ministry of Health, according to a WHO press release.
The conference seeks to assist an ongoing international campaign to “curb the impacts of cancers, cardiovascular disease, diabetes and chronic lung diseases,” and support member states’ efforts to develop policies and programmes on healthy lifestyles and NCD prevention.
Can you say, “compulsory licensing?”
The goal of the conference is to highlight the scale of NCDs and their socio-economic impact, to review international experience on prevention and control, and to provide evidence on needs to boost prevention “as part of national health plans and sustainable development frameworks.”
Can you say “Thailand?” Can you say “Brazil?”
A group of six nongovernmental organisations submitted recommendations to WHO member states prior to the meeting. They are calling for “affordable, appropriate, and good quality medicines, vaccines and diagnostics to persons suffering from NCDs in low- and middle-income countries,” according to the recommendations.
And yes – it’s the usual suspects.
Knowledge Ecology International, Médecins Sans Frontières, Oxfam, Third World Network, Universities Allied for Essential Medicines, and Young Professionals Chronic Disease Network described a shortage of NCD medications in developing countries, even for medicines that are off-patent. Generic medicines production is threatened, they said, as developed countries are seeking to include data exclusivity in free trade agreements with developing countries.
See – they buried the lead.
In particular, they recommended safeguarding generic production as the most effective way to lower prices, and for member states to use flexibilities enshrined in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Sound familiar?
The groups also advised incentivising research and innovation, and called on countries to: adopt strategies which de-link the cost of medicines from the cost of research and development, and apply the concept of prizes as an incentive for innovation in cancer treatment. They also called for the provision of funding to study the feasibility of cancer prize funds in both developed and developing countries. And the NGOs asked for quality assurance so that medicinal products meet WHO quality standards.
Ah yes, the famous “prize” idea. The same idea that has failed everywhere it has been tried – most famously in Soviet Russia. For more on this idiocy, see here.
The complete IP Watch article can be found here.
Danger Will Robinson. Danger.
Forest is sticking by its chief. "No one has ever alleged that Mr. Solomon did anything wrong, and excluding him [from the industry] is unjustified," said general counsel Herschel Weinstein. "It would also set an extremely troubling precedent that would create uncertainty throughout the industry and discourage regulatory settlements."
From the Wall Street Journal -- many important lessons to be learned -- as well as one really cool name: Merit Cudkowicz.
ALS Study Shows Social Media's Value as Research Tool
A new clinical trial found that lithium didn't slow the progression of Lou Gehrig's disease, but the findings released Sunday also showed that the use of a social network to enroll patients and report and collect data may deliver dividends for future studies.
The study was based on data contributed by 596 patients with the disease, formally called amyotrophic lateral sclerosis or ALS. By showing that the drug didn't have any effect on progression of the condition, it contradicted a small study three years ago that suggested such a benefit was possible.
The new study, published online in the journal Nature Biotechnology, represents an early example of how social networking could play a role in clinical trials, an area of medical science with strict procedures that many would consider especially difficult to apply in the online world.
"The approach has tremendous potential,'' said Lee Hartwell, a Nobel Prize-winning scientist now at Arizona State University, and formerly president of the Fred Hutchinson Cancer Research Center. Standard clinical trials play a central role in the research enterprise of both of those institutions.
Dr. Hartwell, who wasn't involved in the study, said social-network trials aren't likely to replace conventional randomized, double-blinded, placebo-controlled trials, the gold-standard for generating medical evidence. But such trials have become so complicated and time-consuming that new models are needed, he said.
Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.
In many diseases, "sometimes the alternative is not our way or the old way. It is our way or it is not studied at all,'' said Dr. Wicks, the research and development director at PatientsLikeMe, a closely held health-data sharing company in Cambridge, Mass., that ran the lithium study.
More than 4,300 patients are on the PatientsLikeMe ALS site, where they frequently share information on how their disease is progressing and strategies they are using to fight it.
Jamie Heywood, chairman and co-founder of PatientsLikeMe, said the idea for the new study came from patients. After the 2008 paper reporting lithium slowed down the disease in 16 ALS patients, some members of the site suggested posting their experiences with the drug in an online spreadsheet to figure out if it was working. PatientsLikeMe offered instead to run a more rigorous observational study with members of the network to increase chances of getting a valid result.
The company developed a tool to standardize collection of patient data, including lithium blood levels in patients. They used a questionnaire from conventional ALS trials to gather patients' self-reported data on functions such as swallowing, walking, and breathing.
In conventional studies, patients are randomly assigned to a treatment or control group to reduce sources of bias. Neither doctors nor patients know who is getting the drug.
In the on-line study, patients decided themselves if they wanted to take lithium. They needed to persuade a doctor to write a prescription. They were also able to see on the website how others taking the drug were faring in real-time. All of this raised chances that the study could lead to a false conclusion.
To address the concern, PatientsLikeMe developed an algorithm that matched 149 patients taking lithium with at least one other ALS patient on the site who didn't take the drug. A total of 447 patients were among this group that researchers considered controls.
The study didn't find any difference in disease progression a year after treatment between those taking lithium and the control group, researchers said.
Mr. Heywood said the result was apparent nine months after the study was launched. Conventional trials typically take more time just to enroll patients, he noted. Costs for drugs and recruiting patients were avoided.
Merit Cudkowicz, an ALS researcher at Harvard Medical School who was an investigator on a standard lithium clinical trial, said social network-generated data can offer valuable insights, but she cautioned that the PatientsLikeMe study was not a substitute for more rigorous studies. Two conventional on-going ALS studies are designed to see if lithium has a very small effect on survival, something the PatientsLikeMe study wouldn't be able to pick up.
"The thing you don't want to do in a fatal illness is to throw out potentially good drugs that might have small but meaningful effects,'' she said.
| Standard Clinical ALS lithium trials | Social Network ALS lithium trial |
Speed | About a year and a half to design and recruit. Additional time to analyze data | Nine months to design, recruit and present preliminary results |
Recruitment | Patients are recruited via doctors, usually at specialist centers in urban areas | Patients self-select through the Internet, regardless of where they live |
Control Group | Patients randomly selected to receive placebo | Patients selected by closeness in historical progression of the disease |
Data Openness | Group data are published | Group and individual data are made available online |
Source: PatientsLikeMe, WSJ research
Write to Amy Dockser Marcus at amy.marcus@wsj.com
In the immortal words of Theodore Roosevelt, “When you are in a hole, stop digging.”
I refer, of course, to the FDA’s embarrassing “Bad Ad” program. After the initial rollout last year in which 33,000 health-care providers were informed about the program, an aggressive agency media effort, brochures, and medical meeting outreach the initiative has resulted in some skin in the game … one letter … for “Derma Smoothe Body Oil.”
At best this effort isn’t, um, cost effective.
At worst, it’s compliance through secret commination. Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber? Really? Whatever became of transparency. What’s next? Anonymous adverse event reporting?
The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law. In the Old West this was more generally referred to as a posse, or worse – a lynch mob.
Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy. A smart move by the FDA would have been to allow the program to quietly wither away.
Instead, the agency is going on the offensive – making a bad idea even worse by holding it up for broader public scrutiny that will, undoubtedly further embarrass the agency and attract Congressional scrutiny.
Witness this media alert (I am not making this up):
FDA CONSUMER HEALTH INFORMATION – April 28 Webinar: Bad Ads Program
The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.
Responsible promotional efforts can give health care professionals valuable information about the latest drug treatments. But not all promotions are accurate and balanced.
Through its Bad Ads Program, the Food and Drug Administration (FDA) asks health care professionals for help in making sure the promotion of prescription drugs is not false or misleading.
Learn how the Bad Ads Program helps protect the public during a 30-minute webinar.
An opportunity to ask questions will follow the presentation.
When: Thursday, April 28, 12:00 p.m. (ET)
Length: 30 minutes
Where: To join the webinar, see the instructions at
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm249817.htm
Host: Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research
Featured speaker: Catherine Gray, Pharm.D., of the Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research.
This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.
If you want a more detailed discussion of the “Bad Ad” program’s failure, have a look at the article, “FDA's 'Bad Ad' Program Generates One Warning Letter in First Year” in the current edition of Advertising Age.
The complete article can be found here.
As the weather turns warmer and you’re looking for some beach reading, may I recommend FDA’s, “Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century.”
And therein the first issue. If the FDA views it’s job as only responding to challenges, that needs to change. The FDA needs to be a change agent – to drive change.
As the bard said, “Action is eloquence.”
The good news is that, under “Vision,” the report reads as follows:
FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.
Leadership. Crucial. Both domestic and international. Absolutely.
There are many crucial initiatives (and I am pleased to report that advancing regulatory science is given a lot of ink). But since we are dealing with the future here, the report is lacking in, what we might call, PDUFAbulousness.
Here’s what the report says about “accountability” --
Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the quality and ethical conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK. We understand the importance of FDA's work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on the responsibility.
Hurrah. But one must add, “yes, but additional Congressional oversight might help too.
There seems to be an inability (or a desire?) to openly discuss the importance and urgency of collaboration with industry. Consider this segment under the header, “Innovation/Collaboration” –
We have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come.
We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system.
One assumes that by “the private sector” the agency means “regulated industry.” So why don’t they say so? Why the need for code language. At the end of the day, if you can’t say it, you won’t do it. This is particularly disturbing relative to the Critical Path Initiative. And here’s a question – why do the words “Reagan/Udall not appear anywhere in the report?
The full report can be found here.
And enjoy the read.
Good news! The UK’s Code of Practice regulator has issued guidance on social media and other digital communications tools.
Bad news! There’s precious little relevance for American marketers.
Nevertheless …
The PMCPA has put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharma’s self-regulatory Code, because “there have been few complaints about digital communication.”
Ah, our transatlantic cousins doth protest too little!
The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Code’s existing ban on promoting prescription-only medicines to the public. “Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction."
The PMCPA’s Q&A can be found here.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
