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fter a year of anticipation, the United Nations on Wednesday released a lengthy report that urges governments to take various steps to ensure greater access to needed medicines. And the list contains several proposals that have previously caused struggles with the pharmaceutical industry, suggesting the agency effort may be difficult to actually implement.

The report comes amid rising anxiety that too many people in a growing number of countries are unable to afford medications, whether these are the newest salves or older remedies. At the same time, the panel also addresses an equally compelling concern that not enough is being done to develop drugs to treat diseases that predominantly afflict poor populations.

“Our hope is to boost R&D for neglected diseases — or better said for neglected patients — and to encourage governments to control prices and quality of the needed products,” Ruth Dreifuss, a former president of the Swiss Confederation and one of two cochairs of the UN panel, wrote us. “The right to health is everybody’s right.”

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Among the recommendations: the UN panel suggested countries should pursue compulsory licenses, which allow countries to sidestep patents and arrange for an alternative version of a medicine to become available. Despite long-running disputes over access, though, governments have shied away from pursuing licenses over concerns about repercussions.

A recent high-profile example is playing out in Colombia, where the government made plans to issue a license and sidestep a patent for a Novartis cancer drug. The move prompted US Senate staffers and US trade officials to threaten the Colombian government by withholding support for peace talks with rebels and a trade agreement.

Consumer and patient advocacy groups largely praised the UN report. Doctors Without Borders, for instance, called it a “landmark report.” But some complained that the panel did not go far enough in some ways. Beyond encouraging governments to issue these licenses, Health GAP said the UN should have “condemned trade agreements and national laws” that do not make clear that countries have the right to issue a compulsory license.

The panel also suggested countries should amend patent laws so that companies can only obtain patents when “genuine innovation” has occurred. Patient advocates argue that the pharmaceutical industry unfairly tries to extend monopolies on their medicines by filing applications for patents that, in reality, represent minimal or modest changes.

The panel also said countries should require drug makers to disclose certain costs — such as R&D, production, and marketing. The goal is to spur more transparency from drug companies, which have long argued that higher costs justify higher prices. This thinking has also prompted lawmakers in several states in the United States to introduce bills with such requirements, although only Vermont has passed a law.

Another recommendation is for companies that receive public funds to publish their research findings. On a similar note, the panel suggested that drug makers should make publicly available all anonymous patient data from completed and discontinued clinical trials. The report recommended data sharing and data access should be a condition for public grants for R&D.

Here are some of the reactions:

“The most important recommendations from the UN experts is to delink the cost of R&D from the prices of drugs,” said Jamie Love of Knowledge Ecology International. “You cannot rely upon high drug prices to finance R&D without harming patients and creating unequal access. Policy coherence means making innovation and access happen at the same time. Delinkage is key to policy coherence.”

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“Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions,” said Dr. Bernard Pecoul of Drugs for Neglected Diseases Initiative.

The US Department of State released a statement saying it was “deeply disappointed,” because the report “detracts from, rather than advances” increasing access to medicines while supporting development of new treatments. “As the United States made clear in its submission to the Panel in February 2016, the narrowly-focused mandate of the Panel was flawed and unlikely to lead to outcomes that adequately address this complex issue.”

“It is equally regrettable that the panel worked under the presumption of ‘policy incoherence’ between intellectual property rights, international trade liberalization, and human rights, while failing to properly recognize the important role that these systems play in incentivizing drug development and expanding access to medicines around the world. Intellectual property rights and trade are essential to medical innovation, which is fundamental to promoting global health.”

The Pharmaceutical Research & Manufacturers of America was not pleased, though. The industry trade group called the report a “a missed opportunity to address the wide array of barriers to access that far too many people face every day.”

The panel “should have provided the opportunity for an informed, balanced, and inclusive dialogue that can make a difference to the lives of people who do not have adequate access to treatments for these and other reasons. However, the panel’s report acknowledges that it was limited in its mandate and unable to look at all the factors influencing access to medicines,” PhRMA added.

“As a consequence, the final report focuses narrowly on solutions which fail to recognize and address the complexity of biopharmaceutical research and development and the significant work already taking place to advance access to care. As such, neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system.”

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  • Scientific Foundation for Cordycepin Studies

    Scientific Foundation for Cordycepin Studies was created in 2014 in Paris, France and has the task of scientific research related to pain relief during cancer treatment and cancer prevention.

    Studies of the pain relief during cancer treatment
    Cancer prevention

    Research on the pain relief during cancer treatment by bioactive compound (cordycepin) that could simultaneously inhibit the growth of cancer cells. The researchers are optimistic in observing the tumor-shrinking effects, reducing cancer pain.
    We try to conduct clinical trials of cordycepin, bioactive compound to inhibit the growth of tumors and specially reduce pain during cancer treatment ( optimistic result by researchers in Japan and in Korea).
    Scientific Foundation for Cordycepin Studies
    The Scientific Foundation for Cordycepin Studies would like to collaborate with Doctors at Support treatment of cancer center in Ho chi Minh City,Vietnam.
    The project contents 2 steps.
    1- Production of cordycepin by effective process
    a-Purification, isolation and cristallization process resulting the production of purified cordycepin.
    Cordycepin increased sub G1 and G2/M phase arrest on HT-29 cells at the concentration of 100μM, whereas cordycepin at 200 μM and 400μM increased G1 phase arrest.
    Product process: production of cordycepin and its purification – Laboratory scale production.
    b- Advantages of cordycepin usage:
    Cordycepin (3′-deoxyadenosine) as one of the active ingredients of WECS (water extracts of Cordyceps sinensis), according to experiment, cordycepin showed an anticancer effect through the stimulation of adenosine A3 receptor, followed by glycogen synthase kinase (GSK)-3βactivation and cyclin D1 suppression.
    Cordycepin showed an antimetastatic action through inhibiting platelet aggregation induced by cancer cells and suppressing the invasiveness of cancer cells via inhibiting the activity of matrix metalloproteinase (MMP)-2 and MMP-9, and accelerating the secretion of tissue inhibitor of metalloproteinase (TIMP)-1 and TIMP-2 from cancer cells.
    In conclusion, cordycepin, an active component of WECS, might be a candidate anticancer and antimetastatic agent.
    c- Product , usage and market
    Product: powder, solid.
    Usage: pain relief during cancer treatment and inhibiting the cancer cells.
    d- U.S. National Library of Medicine
    Cordycepin is known to have many pharmacological effects such as anti-tumorigenic, anti-inflammatory and anti-angiogenic activity. However, cordycepin induced apoptosis through the DR3 pathway in human colon cancer cells has not been studied. The effect of cordycepin on anti-proliferation was investigated in this study. Cordycepin significantly inhibited cell viability in a dose and time-dependent manner. Cordycepin increased sub G1 and G2/M phase arrest on HT-29 cells at the concentration of 100 μM, whereas cordycepin at 200 μM and 400 μM increased G1 phase arrest. Cordycepin induced apoptosis in HT-29 cells in a dose-dependent manner as detected by Hoechst and Annexin V-FITC staining. Intracellular ROS levels were higher in cordycepin treated cells as compared to control cells. The protein related to apoptosis was determined by antibody array. p53 and Bax expression increased treatment with cordycepin for 18 h. DR3, caspase-8, caspase-1, cleaved caspase-3 and cleaved PARP expression increased. These finding suggest that the cordycepin induces apoptosis through the DR3 pathway in human colon cancer HT-29. These findings suggest that cordycepin should be evaluated further as a therapeutic agent in human colon cancer.
    e- The actual markets of cordycepin are Japan,Korea and China. The researchers of these countries experienced cordycepin as active agent anti-tumor cells in reducing adverse effects and also be applied to multiple forms of cancer.
    f- Process of preparation: raw materials, production, purification of cordycepin.
    g- Usage of cordycepin as pain relief during cancer treatment and inhibiting of cancer cells.
    2- Vietnam and cancer-Cordycepin – Clinical trials collaboration-Funding (needing funds for clinical trials in Vietnam)
    Clinical trials of cordycepin : Cordycepin as a 1-hour IV infusion.
    a- We have relations with Doctors at the Support treatment of cancer center in Ho chi Minh City,Vietnam.
    b- Exclusion Criteria: Failure to meet inclusion criteria, uncontrolled active infection, extramedullary (CNS) disease, serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness.
    c- Funds: we start the clinical trials in several difficulties also funds to get start the use of cordycepin molecule at laboratory scale production and conduct the clinical trials in collaborating with Doctors at the Support treatment of cancer center in Ho chi Minh City for the low income’s patients in Vietnam.
    We are in need of financial assistance .
    J.Ros
    ( Hong Nguyen )
    Scientific Foundation for Cordycepin Studies
    http://scientist-aircraft.blogspot.fr/p/contact.html

    * From the Big Bang to mankind
    ( announced for the Nobel Prize 1996 )
    * Handbook of technical trading
    Scientific way to trade successfully 2009
    * The civilization on the erroneous direction – On the erroneous direction
    ( Climate change, deforestation, overpopulation, and cancer 2017)
    * Scientific Foundation for cordycepin studies
    Reduce pain during cancer treatment
    Submitting new drug application 2016 – We are searching a US pharmaceutical laboratory’s partner – Clinical trials in collaborating with Doctors at the Support treatment of cancer center
    in Ho chi Minh City,Vietnam 2017
    * Biophoton: new basis of human biology
    E mail : J.rostrand@gmail.com
    Tribartram6@gmail.com

  • While I agree that access bf price have become an issue at the end of the day this is a business that’s purpose walks a fine line between making money and helping people and too often opts for the former and not the latter. That being said I think that allowing countries to ignore patents sets a very dangerous precedent. If a country begins to use that what is to stop that coin from using it in other industries arguing that they have this right to drive improved quality of life for their people?

  • Pharma’s focus is not to have drugs for the masses but high priced drugs for few who are part of the subsidized healthcare system. That way no one knows what the real drug prices. Pharma is fraught with inefficient methods and no one wants to address or fix them. If they did some of the pharma companies will disappear.

    Pharma’s recent with their inability to create drugs for masses has become neglected drugs for few. Not too far in distant future this could come and haunt them as doctors and patients would stop paying for marginally improved drugs.

    How Pharma would handle their day of reckoning would be interesting.

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