By VC | July 9th, 2010
Posts Tagged ‘Vaccine’
Posted by Admin on December 27, 2010
After the FDA approves a new drug, it rarely faces follow-up studies that might reveal serious and possibly fatal side effects. Some dangers remain hidden for years until an accumulation of disasters sparks lawsuits. Faced with litigation, corporations must cough up data—and sometimes choke on it.
A suit against drug maker Wyeth freed 1,500 documents that yielded “unprecedented insights into how pharmaceutical companies promote drugs,” wrote Adrianne Fugh-Berman in a September study in PLoS Medicine. The 14,000 plaintiffs who took the menopausal hormone therapy (HT) Prempro claim that Wyeth distorted study results and hid evidence of harm. Some patients traded the temporary inconvenience of hot flashes for the permanent inconvenience of death.
It was not as if Wyeth didn’t have reason to suspect serious risk. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use. To counter this side effect, Wyeth added progesterone and created Prempro. But the new combo not only failed to prevent cardiovascular disease, it increased the risk of breast cancer, stroke, dementia and incontinence, according to the 2002 Women’s Health Initiative study.
For decades Wyeth had promoted HT and the diseasification of menopause through tried and true schemes: First, it redefined a normal process—in this case aging and menopause—as an illness treatable with drugs. After cherry picking studies, some conducted off-shore, it hired specialized companies to ghostwrite favorable articles for medical journals, and paid doctors to sign their names—thus creating the impression that independent researchers, not hacks-for-hire, had authored the articles.
“Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ‘benefits’ of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles,” Fugh-Berman concluded.
DesignWrite, Wyeth’s hired ghostwriting outfit, boasts “long experience in blending scientific and clinical issues with marketing needs.” It cranked out more than 100 articles and presentations for journals and symposia touting Prempro’s virtues, and then paid prominent doctors and researchers who contributed little more than their names.
A particularly lucrative medical market, with a history of recalls and scandal, is the $200 billion U.S. medical device industry for replacement joints, pacemakers and CT scanners. Fugh-Berman’s study of conflicts of interest, using disclosures forced by government investigations, revealed that in the year ending in January 2009, five medical device companies doled out 1,654 payments to orthopedic surgeons and researchers that totaled more than $248 million. Fewer than half the experts who published articles dealing with the “donor” company’s products disclosed their financial relationship.
Big pharma’s stake in cooking the books is obvious, but why are medical journals complicit? One reason is that unlike most of the web, most medical journal sites protect their material behind a sturdy pay wall, and may charge up to $40 per reprint. Drug companies sometimes buy up thousands of product-favorable reprints to distribute free to doctors, thereby providing a cash incentive to journals that publish articles likely to be reprinted.
If journal articles are insufficiently laudatory as marketing vehicles, drug companies can turn to supplements. Separately bound, these publications bear the journal’s name, but are industry produced and rarely peer-reviewed. Wyeth, for example, mailed its pro-Prempro supplement with the journal Women’s Health in Primary Care to 128,000 physicians.
In 2000, big pharma firms spent more than $15.7 billion promoting prescription drugs in the United States. Like other mega corporations, they have great advantages over citizens: They are rich, powerful, protected by laws and tax rules, and given the rights of people while shielded from many of the responsibilities. On our side, we have timid or weak politicians and bureaucrats, activist organizations and the ability to sue. Unfortunately, lawsuits tend to punish rather than prevent. But the deterrent effect of large settlements, the bad PR and the discovery of data and records are nonetheless components in mitigating the epidemic of corporate greed.
Terry J. Allen, an In These Times senior editor, has written the magazine’s monthly investigative health and science column since 2005. how_to_manufacture_a_disease/
- 6 cases of whooping cough reported at Tacoma school (seattletimes.nwsource.com)
- Manufacturer offers low cost vaccine against killer diseases | Sarah Boseley (guardian.co.uk)
- Reliable Biopharmaceutical Corporation Hires David Feldker (eon.businesswire.com)
- Cytovance Biologics LLC Awarded Biopharmaceutical Development and Manufacturing Contract by Selexys Pharmaceutical Corporation (eon.businesswire.com)
- FDA warns Tessalon cough capsules a risk to kids (thenewstribune.com)
- Simcere Pharmaceutical Group Provides Update on Jiangsu Yanshen (prnewswire.com)
- Supreme Court Will Look at National Childhood Vaccine Injury Act (newsflavor.com)
Posted by Admin on September 4, 2010
by Christina England
August 27, 2010
Vaccine programmes grind to a halt in India once more, when four children died after they received the measles vaccination in Lucknow. The four children were reported to have fainted soon after they were vaccinated and witnesses reported seeing the children’s eyes roll back as they began to have seizures. All of the children were under the age of two years of age, with the youngest being just six months. Sadly the children died before medical aid workers could reach them.
As news of the deaths spread, immunization drives in 41 villages have been halted until further investigations have taken place.
“The immunisation programme was being conducted as part of the government’s Jachha Bachha Suraksha Abhiyan launched on August 15. Minutes after vaccination, the children started gasping for breath.”
NDTV reported that the Health Ministry has ordered an inquiry after the four infants, all believed to be below nine months, died after the vaccine. The inquiry team has yet to reach Uttar Pradesh, however, the Uttar Pradesh government has announced compensation for the families of the victims.
This is not the first report of adverse reactions after the measles vaccination. The measles vaccine has had a dubious and rather tainted history. In the UK, a government report dating back to 1968 , exposed on the website VacTruth.com in May of this year stated:-
Section 6 – Reactions
“Mild febrile reactions and transient rashes may be expected to follow the administration of the vaccine in a substantial proportion of cases. The rise of body temperature which may occur from 5 to 10 days after vaccination – usually about the 8th day – is due to the multiplication of the attenuated virus. This febrile reaction, when it occurs, seldom lasts more than 24 to 48 hours. The Committee on Safety of Drugs has agreed that severe and unusual reactions to measles vaccine should be reported on the yellow card used for reporting adverse reactions to drugs. The Committee does not however, wish to receive reports of mild febrile reactions and rashes associated with the use of this vaccine.”
This proves that the UK government as far back 1968 knew that the measles vaccine gave children adverse reactions, in fact, after reading the papers it is very clear that they were quite happy to be offering babies a vaccine that they admit, in a substantial proportion of cases, gives them high fevers and rashes.
That same report stated in section 7 that it was unwise for this vaccine to be given to children under the age of 9 months.
“Section 7 – Routine Vaccination
The live measles vaccine should not be given to children below the age of nine months since it usually fails to immunise such children, owing to the presence of maternally transmitted antibodies.”
The Joint Committee of Vaccination and Immunization who advise the government said that the vaccine should instead be given to children in their second year of life after the completion of the immunisation against diphtheria, tetanus whooping cough and polio.!
Yet it appears that none of this was ever even considered before the children of India were vaccinated.
In India ,this is the third vaccine disaster this year. In April the Indian Times wrote an article Hib vaccine: Are press releases telling whole truth? – Health … and reported that their country was being misled over the effectiveness of the HIB vaccine. The vaccine for Haemophilus influenzae type b (the main cause of childhood meningitis and pneumonia) was advertised as being safe and effective however, in the Medical Journal of Medical Research three senior paediatricians accused three agencies, USAID, John Hopkins Bloomberg School of Public Health the Hib Initiative and the GAVI Alliance of misrepresentation of the facts by selectively and inaccurately reporting the actual findings of the Bangladesh Hib probe study in order to promote the vaccine’s wider use. The India Times said :-
“According to the Agencies joint press release the results of the Bangladesh study conducted in 2007 “showed that the routine immunization of infants with the Hib conjugate vaccine prevented over one-third of life-threatening pneumonia cases and approximately 90 per cent of Hib meningitis cases”.
It further said “this vaccine study builds on the evidence of the real burden of Hib pneumonia” in Indonesia.
Both these statements argue in favour of Hib vaccination in developing countries through “selective interpretation/presentation of the actual research findings”, says Jacob Puliyel at St. Stephens Hospital in New Dehli and one of the doctors finding fault with the press release.
The Bangladesh study compared Hib vaccination status among children with confirmed pneumonia or meningitis against those without these diseases (controls). The major finding that there was “no difference” in the Hib vaccination status of children with pneumonia compared to community controls was omitted in the press release, the Indian doctors claim.
The study also found that among those who received all three doses of the vaccine, there was “no statistically significant protective effect” against either confirmed meningitis or probable meningitis but it found statistical significance in a sub-group that received only two doses of the vaccine.”
The Times continued:-
“The press release made another misrepresentation by saying the study “builds on” evidence of the burden of Hib pneumonia from Indonesia whereas the Indonesia study actually reported more pneumonia in the Hib vaccinated group than controls, says Puliyel.
In fact, the Indonesia study paper concludes by saying
” Hib Vaccine” will not have a major role in efforts to reduce the overall burden of respiratory illness…..as improvements in nutritional status, maternal education and socioeconomic status” (can have).”
Sadly India were to be told further vaccine lies again in April this year, this time relating to the Gardasil vaccine. In an article I wrote at the time India suspends use of HPV Gardasil vaccines :: Weekly Blitz I reported the following:-
“It seems that the HPV vaccine Gardasil manufactured by Merck, has been in the spotlight again this week, as the news pours in that the Indian Council of Medical Research (ICMR) has decided to immediately suspend it’s cervical cancer control vaccination programme for girls. The action was taken after 4 girls died and 120 were injured after receiving the vaccine.”
Further on I continued by adding:-
“The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche. Women activists fear the vaccine may impact the mental health of girls who have shown no signs of distress so far.”
A few weeks later a letter appeared on the front page of the The Hindu on the 14th April 2010 to Azad that read:-
“Another issue which unfortunately has not been addressed in your letter is the conflict of interest involved in the PATH project. This NGO is a partner of the manufacturing company MERCK in other projects.
As a partner, it can be easily understood that the conflict arises from the interests of the subjects of the project, in this case children, on the one hand, and the vaccine manufacturer, on the other.
If there is not to be a cover-up of what appears prima facie to be a case of connivance with a vaccine manufacturing company in violation of set guidelines, I would once again request you to kindly look into the aspect of the inquiry, both in its terms of reference and in its composition.”
So if The Hindu’s research is correct and all indications show that it is, the NGO can hardly be classified as impartial, can he?
The campaign group the Truth about Gardasil were disgusted by these revaluations. India was at the time a country trying to come to terms with the fact that their children were used as part of an experiment, when all the time it was known that the vaccine used had been seen to cause adverse reactions worldwide.
The Truth about Gardasil put out a press release stating:
“Where is representation for the families of the four young tribal girls in Khammam district who died following the vaccination? Where is representation from the 70 public health organizations, networks, medical professionals, human rights groups and women’s organizations that brought the HPV vaccine campaign in India to its knees on April 7, 2010 by voicing their intense opposition to the unethical nature of the HPV vaccination ‘projects’ conducted in Andhra Pradesh and Gujarat by PATH International, in collaboration with ICMR and State Governments?
Where are these organizations now? Perhaps they will be allowed to sit in the balcony of their congressional hall just as the women adversely affected by the first birth controls pills in the 1960’s had to do as they listened to senate testimony orated by men as they argued the risks and benefits in January of 1971.”
However, the deaths did not stop there as the death toll in India rose to 6 but according to the reports that followed none of the deaths had anything to do with this vaccine. One article reported the deaths of the 6 girls was not due to vaccine failure but according to Indian minister they were put down to various causes including, viral fever, drowning, suicide and a suspected snake bite.
If vaccines continue to injure and kill the children of India, India may decide to become the first country to ban vaccinations altogether, after all who could blame them?
As yet no one is sure why there have been so many vaccine disasters in India this year. It seems that false advertising by the drugs companies and conflicts of interest could be held responsible at least to some extent.
- India halts HPV vaccine trial after six girls die, US does nothing in response to 67 deaths and counting (NaturalNews.com)
- India halts HPV vaccine trial after six girls die, US does nothing in response to 67 deaths and counting (angryindian.blogspot.com)
- Abbott Halts Sale of Flu Vaccine Business (dealbook.blogs.nytimes.com)
- Vaccine Zombie video www.VaccineZombie.com (current.com)
- Health Ministry sends team to probe vaccination deaths (thehindu.com)
- Health Ministry team to probe vaccination deaths (thehindu.com)
- Abbott abandons plans to sell vaccines business (sfgate.com)
- Vaccine has cut child cases of bacterial pneumonia, says study (eurekalert.org)
- BioEducation: Vaccines, Drugs and Risk (biojobblog.com)
- Vaccines, War and Remembrance (beliefnet.com)