GSK Wikileaks Cables..[]=ps&qproject[]=cc&qproject[]=fp&qproject[]=cg&q=GlaxoSmithKline#result

5. (C) Nahas characterized U.S. economic sanctions against Syria as a “PR disaster” that strengthens hardliners’ arguments to Bashar against improving relations with the U.S. He claimed he had very little personal stake in the lifting of U.S. sanctions, as his only U.S. business affiliation is with Oshkosh to provide rescue vehicles at Syria’s airports. (Note: Post understood that the interagency had taken a decision on a pending export license application for Oshkosh in mid-March 2009, but Oshkosh had not contacted Nahas Enterprises with the result of that decision as of this writing. End note.)

6. (C) Nahas lamented, however, that U.S. sanctions are deterring the UK pharmaceutical giant GlaxoSmithKline (GSK) from purchasing Avenzor, Nahas’ financially-troubled pharmaceutical factory in Syria. GSK, he said, is afraid that U.S. sanctions would prevent them from importing the necessary automation hardware and software required to manufacture GSK products in Syria.

(Note: An executive with Unipharma, the largest pharmaceutical manufacturer in Syria, recently told us that GSK had found Avenzor in violation of its contract to make Panadol a few years ago. According to our contact, Avenzor technicians were discovered using cheap, imported acetaminophen from India instead of a more expensive required ingredient. Following the discovery, Nahas reluctantly signed away his right as the exclusive Syrian manufacturer of Panadol to Unipharma. End note.)

Sensitive but Unclassified, not for Internet distribution.

1. (SBU) Summary. An effort by the Romanian Ministry of Health (MOH) to address the inordinately high levels of cervical cancer deaths in Romania through a Human Papillomavirus (HPV) vaccination campaign has largely failed. With parental refusal rates of up to 90 percent two thirds of the way through the campaign, the Government of Romania (GOR) has lost control of the public message, with misinformation regarding the safety and efficacy of HPV vaccines prevalent in the media.

What began as a sincere effort to improve the health of Romanian women instead turned into a handy pre-election target for parties looking to undermine the credibility of the current government, which itself invited the fiasco with its own failure to properly educate and prepare the populace. The hope is that, post-election, the new government can be persuaded to develop a better education and outreach campaign and then revisit vaccinating the same age groups of girls in the spring. End Summary.

2. (SBU) Romania has the highest incidence of cervical cancer in Europe and was targeted by Merck Sharpe and Dohme (MSD) and GlaxoSmithKline (GSK) as a good location to develop a broader European market for their respective HPV vaccines. With an average of six Romanian women dying every day from cervical cancer, the companies had hoped that the GOR’s agreement to provide an anti-HPV vaccine at no cost to targeted recipients could be used as a precedent in encouraging other EU countries to follow suit. MSD, maker of market-leading HPV vaccine Gardasil, has been actively pushing this project since May of 2008, when the company invited former Secretary of State Madeleine Albright to Romania to make the pitch for a vaccination campaign (reftel). Albright’s meetings with the GOR were successful, and MOH announced in July it would initiate a campaign in the fall covering all 10- to 11-year-old girls in the country. 3. (SBU) Post has been engaged at various steps in the process, helping to organize the Albright visit, reinforcing her message with officials at MOH, and encouraging the MOH to complete the vaccine procurement procedures in a fair and transparent manner. In the end, MOH decided to split the procurement evenly between GSK and MSD, with the price negotiated directly with each company. While MSD country director Agata Jakoncic says the company did receive a small premium for having a quadrivalent vaccine (GSK’s version only targets two HPV strains), she commended the GOR for bargaining hard with MSD to offer the vaccine at a more than 15 percent discount from the prevailing Romanian market price. 3. (SBU) According to Jakoncic, the political calendar was a major factor in timing of the campaign, with the sitting government determined to begin vaccinating girls prior to the November 30th parliamentary elections as a demonstration of political commitment to health care. MOH completed procurement on a compressed schedule and began offering the vaccine to fourth-grade girls just ten days before elections. Anticipating a positive public reaction, the GOR was blindsided when the press quickly turned negative in what appeared to be a well-orchestrated misinformation campaign. Without clear and coherent information from the central government, local public health officials were clearly unprepared for the sudden push to start offering an HPV vaccine and provided only minimal information to parents in hastily convened school meetings.

4. (SBU) Lacking credible and consistent information from official sources, parents turned to the media, which played up stories of adverse vaccine reactions, claims that Gardasil had led to 20 deaths in the U.S., and even charges (in the face of solid scientific evidence) that there is no demonstrable link between HPV and cervical cancer. The GOR strategy to defuse potential controversy by giving parents a first-ever “opt out” clause for what was billed as a mandatory vaccination quickly backfired; the TV news was filled with images of school meetings across the country where parent after parent raised their hands to refuse the vaccine. To date, 70 percent of girls in the target group have been offered vaccination but the parental refusal rate for them is almost 90 percent, rendering the campaign a failure. The intensity of the negative media was in sharp contrast to the notable silence of top government officials as the campaign came under increasing criticism. 5. (SBU) MOH has suspended the campaign with the school Christmas break looming. MSD’s plan, after the Holidays, is to focus education efforts on the remaining 30 percent of the target group to try to change the tenor of the debate and thus open the door for all girls to be offered the vaccination again later in the spring. Jakoncic expressed great frustration that, early on, the GOR had rebuffed MSD’s offers to help prepare a public relations campaign; officials told her that MSD’s job was solely to supply the vaccine and that MOH would do the rest. After the PR debacle, and now sitting on a large stockpile of unused vaccines with limited shelf life, the GOR is proving more willing to work with MSD to craft an improved message for the girls remaining to be vaccinated. With the elections over, the issue has already faded from the press, and MSD hopes that parents will be more receptive to well-prepared, accurate information in the months ahead. 6. (SBU) Comment.

This appears to be a textbook case of how not to conduct a public vaccination campaign, particularly one involving vaccines that have already met with some controversy in the U.S. and elsewhere. By rushing the campaign to try to score political points, the GOR failed to prepare the ground adequately. This was especially apparent in the school meetings, where poorly trained school nurses and regular classroom teachers were often left on their own to explain the link between HPV and cervical cancer to bewildered parents. Deluged by Internet rumors as well as poorly researched and sensationalistic press reports, it is no mystery that most parents — asked for the first time ever to sign a vaccination consent form — proved unwilling to trust public health authorities. Complicating matters was the decision to focus on 10- and 11-year-old girls, with few parents perceiving an urgent need to vaccinate their prepubescent daughters against a sexually transmitted disease which is only linked to cancer in adulthood. Romanian health authorities may have had good intentions in launching this campaign, but the disastrous execution has been a real setback for public health in this country. Much hard work lies ahead to repair the damage. End Comment. GUTHRIE-CORN

1. (U) SUMMARY: The number of confirmed H1N1 infections in Germany increased by 627 new cases, bringing the total as of August 17 to 12,120. The majority of new infections occurred abroad. The German government plans to order enough vaccine for 80 percent of its population. END SUMMARY 2. (U) At its August 17 press briefing, the National Reference Center for Influenza at the Robert Koch Institute (RKI) confirmed a total of 627 new (laboratory and non-laboratory) H1N1 cases in Germany over the week end. This increases the total number of H1N1 cases to 12,120. New cases were distributed among fifteen federal states: Baden-Wuerttemberg (196), North Rhine-Westphalia (162), Rhineland-Palatinate (71), Bavaria (46), Lower-Saxony (45), Hesse (29), Berlin (11), Mecklenburg-Vorpommern (9), Saarland (8), Brandenburg (24), Saxony (7), Thuringia (7), Hamburg (5), Saxony-Anhalt (4) and Bremen (3).

3. (U) According to RKI, 482 of the 627 new cases are attributed to people returning from travel abroad. New cases include also non-laboratory H1N1 cases from people who exhibited symptoms after being in contact with a laboratory confirmed infected person. So far, all new cases are reportedly mild. 4. (U) North Rhine-Westphalia remains the German state with the highest number of confirmed virus cases with a total of 4,246, followed by Lower-Saxony (2,065) and Baden-Wuerttemberg (1,379 cases). About 23 percent (2,746) of all confirmed infections in Germany have resulted from domestic transmission. H1N1 Vaccine for Eighty Percent of the Population ———————————- 5.

(U) The German Government announced plans to increase the stockpile of antiviral medication and now plans to obtain enough vaccine to immunize 80 percent of the population, up from its prior plan to immunize approximately one-third of the German population. According to the media, an inoculation rate of over 80 percent is necessary to stop the spread of the virus. Germans, however, tend to be vaccine-adverse.

Media reports indicate that fewer than 80 percent are likely to get immunized against the new virus. (Note: Only 22 percent of the population in Germany follow the annual recommendation and gets vaccinated against seasonal influenza.) However, if the inoculation rate is less than 80 percent, the Government could sell excess serum abroad, according to media reports. 6. (U) In order to produce enough “Pandenrix”, the new H1N1 antiviral medication, Dresden-based pharmaceutical company GlaxoSmithKline (GSK) plans to hire an additional 150 workers. GSK currently employs 700 workers. The production of Pandenrix began in July. GSK will produce over 300 million vaccine doses by fall and will be sent to Europe and parts of Asia. BRADTKE

Al-Saleh said that the GCC is considering a Glaxo Smith-Kline (GSK) proposal presented in October for the pre-purchase of a possible new H5N1 vaccine. The Government of Oman is currently representing the GCC in these discussions with GSK. A recent GCC recommendation called for the stockpiling of 10,000 Tamiflu doses for the first GCC country affected by a pandemic.
Al-Saleh said that this stock would likely target Yemen, given that country’s limited resources for pandemic preparedness planning. 7.
U) Note: Embassy Kuwait recently convened a meeting of the pandemic flu working group, comprising relevant Post personnel and four medical officers from U.S. military elements in Kuwait. Participants reviewed the Department’s updated guidance on pandemic preparedness (reftel) and agreed to meet quarterly. Post is in the process of reviewing the actions items outlined in reftel.

One comment

  1. solo49

    Not sure what they might have called the GSK bird flu drug in Germany or elsewhere in Europe but that should be ‘Pandemrix’ (not’ Pandenrix’ as indicated above). ‘Pandem’ meaning widespread (on whatever scale)- ‘Rix’ most probably meaning Rush or Reign. Also Rix-A suffix appended to words, chiefly verbs, to form female agent nouns. It’s intriguing how they dream up these names, E.g. Dopamine (Dope of Mine?), just one classic example.

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