Act Today against S676

Act Today against S676

THURSDAY MAY 9TH 4:30P is the hearing for S 676 has been scheduled in the senate lounge. Only three bills are currently on the agenda for this evening. Show at close to 4:30 as you are able – you can text Aimee 4017410386 to ask about status etc if you are running late.

This is the BAD DATABASE BILL that will automatically enroll every RI resident.

Summary of medical tracking bill S 676:
The Rhode Island Department of Health has introduce Senate Bill 676 via Senator Crowley, to track the medical data of every person in Rhode Island. According to lines 9 & 10, RICAIR (Rhode Island Child and Adult Immunization Registry) will collect, “data elements nationally endorsed by the Centers for Disease Control and Prevention” Meanwhile, CDC endorses ALL data elements that a tracking database collects, “This list does not include all data elements external information systems such as EHRs, vital records, practice management or billing systems are expected to send to an IIS. The list may not include all data elements an IIS produces, stores or sends. Data elements may be derived and architectural solution may differ among IIS.”

We need as many people as possible to show up to this hearing to oppose this bill. Last year it passed on the senate side. PLEASE attend and bring a friend or two with you. We created a Facebook event also so it is easy to share and invite others on social media. https://www.facebook.com/events/423331301562642/

Last year, the ACLU strongly opposed this weak and ineffective opt-out data collection system, citing 5 compelling reasons. Below is a particularly relevant example.
“Finally, and sadly, we have no reason to believe these fears are beyond the pale. In the recent past, the DOH has shown that it does not consider patient confidentiality a priority in its mission. Last year, Committee members will recall, the DOH supported legislation sponsored on behalf of the Attorney General to give law enforcement access to the Department’s prescription drug monitoring database without a warrant. DOH did so only a few years after it got a bill passed to vastly expand the prescription information in that database by agreeing that police would not be able to gain access to the information without a warrant. In the past year alone, the Department has proposed regulations to expand third party access to two other large agency databases with confidential patient information – the health information exchange and the allpayer claims database. There is simply no reason to trust the Department to put the confidentiality interests of patients first once this information is included in a DOH database.”

ARE YOU ALL IN AGAINST THIS INTRUSION OF YOUR MEDICAL PRIVACY AND RIGHTS TO YOUR PERSONAL DATA?! We created a multi step list for those ready to go all in for the fight for your rights. CLICK HERE for that list.

When speaking at a legislative hearing you are given 2 minutes to say your testimony. You may also bring written testimony only and not speak if you would prefer. Please bring 15 copies of your statement with S676 at the top, and your name- email or phone- printed clearly on the documents. The clerk will distribute them to the committee. If you are not able to make it and want us to submit your written testimony on your behalf – please email it to aimee@nohpvmandateri.com.

Talking Points to consider;

~ No limit to data tracking as stated in summary paragraph above.

~ Automatically opting residents into a database is unethical. Currently this already happens with the child database in RI, and has no option to opt out of it. This should never be supported in this kind of way. If a database was to even exist, each resident should need to sign up that they wish to participate, and voluntarily take part in it.

~ The Dept of Health was granted a prescription database with the statement that police officers would not have access to it without a warrant. They later advocated in favor of and a bill passed to allow that very database to be accessible to police in RI without a warrant.

~ The DOH is exempt from HIPAA laws. Once they have the data there is no privacy protection in place.

~ The language for “opt out” of the bill is not defined, and does not guarantee your file will be deleted upon opting out.  The current database for kids has a multi step inconvenient process that does not allow your file to be deleted.

~ The database itself plus the personnel salaries to maintain it will inflate our already very large RI budget. When we can barely pay for our state expenses, why are we adding to the tally when there is no actual need for it.

~ You want the right to make private and non tracked decisions regarding HPV vaccines for your preteens, if they start tracking adults, do you want them bothering you next with getting the HPV vaccine? It was recently approved for through age 45 by the FDA

 

==== Call Your senator ( can find who that is vote.sos.ri.gov) and tell them to oppose this bill that intrudes on your personal data and does not give any form of privacy guarantee. That you do not consent to the DOH having the ability to track any medical data field they decide. ====

 

We have also created a petition that we will print and bring with us to the committee hearing. You can sign and share the petition via database.NOHPVmandateRI.com

The Dept of Health has shown RI on more then one occasion that they should not be trusted. Stop the database tracking bill!

Take action today.

 

 

Thank you for supporting the efforts of Rhode Islanders against mandated HPV vaccinations, you are appreciated.

 

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HPV Vaccines: Betrayal of the Public Trust?

HPV Vaccines: Betrayal of the Public Trust?

In 2013 multiple news articles reported 44% of American parents refusing Gardasil or Cervarix for their children. Between 2008 and 2010, the percentage of parents concerned about the safety of these two vaccines nearly quadrupled. As of 2010, only 32% of eligible girls were vaccinated against HPV. What is wrong with this picture?

Excerpts from national news sources, March 18-22, 2013:

  • USA Today The percentage of parents who say they won’t have their teen daughters vaccinated against the human papillomavirus increases, even though physicians increasingly recommend the vaccinations. Concerns about safety and side effects for the human papillomavirus (HPV) vaccine have increased among parents: 16% cited these fears as the main reason they did not have their daughters vaccinated in 2010, up from 5% in 2008…
  • Medpage Today Parents increasingly say they are worried about the safety of the human papillomavirus (HPV) vaccine and don’t intend to vaccinate their teen daughters… But there is no similar pattern for two other vaccines aimed at adolescents…
  • CNN Health Concerns of mothers and fathers about the safety of the HPV vaccine grew each year, from 4.5% in 2008 to 16.4% in 2010… The number of parents who said they would not vaccinate their children for HPV increased from 38.9% in 2008 to 43.9% in 2010. The main concern was safety.
  • CBS News One of the main reasons parents said they didn’t want their children vaccinated against HPV was because of safety concerns.
  • Bloomberg The number of girls who received either injection (Gardasil or Cervarix) rose to about one-third in 2010 from 16 percent in 2008…
  • FiercePharma A growing share of U.S. parents say they won’t vaccinate their daughters… And that leaves Merck’s Gardasil and GSK’s Cervarix with a shrinking market.
  • The New York Timessuggesting, the need for interventions beyond clinical recommendations like possibly ‘state and federally designed social marketing campaigns.’… Without brushing aside the need to address safety concerns, the increasing rates of HPV vaccine refusal suggest that widespread vaccination will require more than marketing campaigns. Medical professionals need to look for ways to tell a better story to parents and teens about HPV, vaccination and cancer. (emphasis added)

Taxpayer funded social marketing campaigns? Look for ways to ‘tell a better story’ to parents? Who are these people kidding? What happened to investigative journalism? What happened to fact-finding? What happened to fair and balanced journalism?

Has no one considered the possibility that the 43.9% of parents refusing this particular vaccine might have some valid concerns? When will people realize there is a huge difference between ‘increasingly concerned about the safety’ and ‘increasingly aware of the potential risks’? After all, this would not be the first time a prescription medication approved by the FDA as ‘safe and effective’ turned out to be nothing of the sort. Will HPV vaccines be next?

HPV vaccination programs worldwide are based on two assumptions. First, HPV vaccines will prevent cervical cancer and save lives. Second, HPV vaccines will pose no risk of serious side effects. Therefore, it would make sense to vaccinate as many pre-adolescent girls as possible to reduce the worldwide burden of cervical cancer. What happens if both of these assumptions are not based on factual evidence?[1]

Medical Consumers Want to Know:

  1. Since HPV vaccines have never been shown to prevent cervical cancer, why are they being promoted as cervical cancer vaccines?1
  2. Since the majority of HPV infections and a great proportion of abnormal lesions associated with cervical cancer development clear spontaneously without medical treatment, how can these factors be used as ‘end-points’ during clinical trials to reliably predict the number of cervical cancer cases that could be prevented by HPV vaccines?1
  3. How can the clinical trials make an accurate estimate of the risk associated with HPV-vaccines if they are methodologically biased to produce false negatives?1
  4. Why are HPV vaccines marketed so aggressively in developed countries, when 85.5% of annual cervical cancer cases and 87.9% of annual cervical cancer deaths occur in developing countries?[2]
  5. How can passive adverse event monitoring systems (voluntary reporting with no penalty for failure to report), such as those used by most vaccine surveillance systems world-wide, allow the medical regulatory agencies to make accurate estimates on the real frequency of HPV-vaccine related adverse reactions?
  6. How can accurate estimates of the real frequency of HPV-vaccine related adverse reactions be made if appropriate follow-up and thorough investigations of suspected vaccine reactions are not conducted?

The FDA granted Merck’s HPV vaccine, Gardasil, fast track approval in June of 2006, despite the fact that this HPV vaccine failed to meet the FDA criteria for fast track approval.[3] FDA approval of GSK’s HPV vaccine, Cervarix, followed shortly after in January 2007.

According to The New York Times, the CDC Advisory Committee on Immunization Practices recommended adding HPV vaccines to the immunization schedule in the U.S. despite the fact that 64% of the advisory committee members had potential conflicts of interest which were either never disclosed or left unresolved at the time they voted. 3% of the members actually voted on matters they had been barred from considering by ethics officers. News like this certainly does little to enhance the level of public trust.

Is it possible for the FDA to objectively monitor the safety and efficacy of HPV vaccines? One has to wonder since Congress tightened the rules on outside consulting after similarly undisclosed conflicts of interest were discovered within advisory committees at the FDA.

As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales.[4]

Marketing Gardasil to the public under these circumstances is a typical case of unconstrained government self-dealing. The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers.  For example, Dr. Julie Gerberding, as the Director of the CDC, approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil.

How much revenue is generated for the NIH from international sales of HPV vaccines? In November 2010, Dr. Eric Suba submitted a Freedom of Information Request to the Office of Government Information Services to discover the amount. It seems the financial details of the partnership between the NIH, Merck and GlaxoSmithKline are exempt from disclosure. (Read the response received here.) Apparently, transparency in government does not apply to the top 20 revenue producing patent(s) developed at taxpayer expense. Why is the public not allowed to share in celebrating the success of products they financed?

Three Strikes for Gardasil?

  1. September 2011: Recombinant HPV DNA L1 gene DNA fragments, possibly attached to the aluminum adjuvant, were discovered in 100% of Gardasil samples tested. There was no subsequent investigation. The FDA simply declared the ‘expected’ presence of residual DNA is not a safety factor. No documentation was provided. The fact that HPV vaccines were approved by governments worldwide based on manufacturers’ assertions that the vaccines contained ‘no viral DNA’ was completely ignored.[5], [6] The possibility of recombinant HPV DNA fragments being attached to aluminum adjuvant particles was also ignored.
  2. August 2012: One of the antigens used in Gardasil was discovered in central nervous system samples from two girls who died after being vaccinated with Gardasil. No cause of death was identified upon autopsy in either case.[7] HPV-16 L1 gene DNA fragments of vaccine origin apparently attached to aluminum adjuvant particles were also discovered in post mortem blood and spleen samples of a girl who died 6 months after Gardasil injections.[8], [9]
  3. February 2013: It was discovered that the naked HPV 16 L1 gene fragments bound to aluminum particles by ligand exchange in Gardasil have acquired a non-B conformation. This conformational change may have stabilized the HPV 16 gene fragments in Gardasil preventing their normal enzymatic degradation in vaccine recipients.[10], [11] Non-B DNA conformations and their relationship to diseases has been studied since the 1960’s. Based on current scientific knowledge, the human genetic consequences of these non-B DNA structures are approximately 20 neurological diseases, approximately 50 genomic disorders and several psychiatric diseases.[12], [13] The impact of injected foreign non-B DNA on human health is totally unknown. 

Why have none of these discoveries sparked a single investigation in any country? Why is no one concerned when genetically modified viral DNA fragments are found in vaccines that are reported to have no viral DNA? Why is no one worried about those viral DNA fragments being attached to aluminum (a known toxin) possibly creating a new chemical compound of unknown toxicity? Why are no red flags raised when those viral DNA fragments attached to aluminum acquire a non-B conformation – something known to be associated with multiple debilitating diseases? Anyone with an ounce of common sense should demand to know why those charged with approval, recommendation and safety monitoring of these vaccines appear to be utterly unconcerned about the future health implications of any one of these discoveries, much less all three of them.

What kind of ‘expert’ advice is being given to YOUR government health officials?

Israel’s Advisory Committee on Infectious Diseases and Inoculations held a teleconference on 30 January 2013, to discuss the proposed introduction of HPV vaccines into the country’s school inoculation program among other issues. The official transcript of that meeting, dated 11 February 2013, provides some interesting insights for medical consumers who question HPV vaccine safety.

Ron Dagan, MD, is Professor of Pediatrics and Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva, Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka University Medical Center, also in Beer-Sheva. An active researcher and international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His expert advice to Israel’s Advisory Committee regarding potential HPV vaccine implementation is as follows (translation provided-emphasis added):

We are dealing with injections, some of which given in 3 [separate] doses, which are delivered to teenage girls. Many side effects are to be expected. During the week following the vaccine delivery of the injections many serious events which are not related/linked to the vaccination are expected: fainting, deaths and convulsions/fits. This needs to be taken into account. Even if it is not rational, if these events happen in class they may damage the general perception/status of the vaccinations. This is happening all over the world all the time. We have already dealt with a similar issue in relation to the delivery of MMR with TD and Polio and we have accepted the nurse’s proposal to split these between grades 1 and 2. The nurses are suitable to make recommendations to the committee in relation to this issue. In relation to the side effects, we need to be prepared in advance and not simply react after the fact. I propose we consult with the English representatives as to how they’ve gone about this. We must prepare for the delivery of the new vaccine. The nurses need to know they are going about this in the way they are most comfortable with (/have the most control over/familiarity with).

If this is an example of the expert advice vaccination programs are based on, it’s no wonder medical consumers are questioning HPV vaccine safety, efficacy and need. Many side effects are to be expected? Fainting, deaths, convulsions and fits occurring during the week following vaccination – yet not related to the vaccine? Preparing in advance for side effects? Consulting with other countries to see how they handled the problem? Are countries around the world being offered similar expert advice?

So, what will it take to solve the HPV vaccine uptake problem?

Parental concerns about HPV vaccine safety are not going to go away in response to social media campaigns. Teaching medical professionals to ‘tell a better story’ is not going to make parents change their mind about Gardasil, Cervarix, or any future HPV vaccine. Platitudes and unsubstantiated reassurances are no longer sufficient.

The time has come for government health authorities to make HPV vaccine manufacturers prove their claims or pull their products from the market. Medical consumers want scientifically proven facts – Safe, Affordable, Necessary and Effective – nothing less is acceptable.


The above article is from SaneVax.org and was written in 2013. This information is still valid and a reminder is in order for the current fight for our rights around the country and in RI about the HPV vaccine. #InformedConsent is essential and very important points are not being disclosed.

Since this article was published, last month there was a change in the dosing scheduled suggestions by the CDC. Where children under age 15 only need to receive two doses vs three doses. More specific details also apply.

Now on Nov 18th the CDC will hold a training to teach health care workers how to encourage the HPV vaccine and how to understand the new dosing recommendations by the CDC from Oct 2016.

Share this blog post with your legislator and schedule a time to sit down and speak with them.

Big Pharma bombshell

Big Pharma bombshell: Judge finds Merck lied in patent trial, overturns $200-million verdict

The public already holds drug manufacturers in low esteem – and now they’ve got more fuel for their opinion.  Federal Judge Beth Labson Freeman of San Jose last week found that Merck & Co. lied to a business partner and to the court itself. Freeman threw out a patent infringement judgment Merck had won against Gilead Sciences, and overturned a $200-million jury award.

This was a big deal, involving one of the most profitable drugs on the market today — Foster City, Calif.-based Gilead’s blockbuster Sovaldi treatment for the hepatitis C virus — and the world’s fourth-largest drug company Merck.

It’s also an enormous black eye for Merck, whose activities the judge said consisted of “systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct.”

But the case does more than raise questions about the integrity of a huge corporation. It’s a window into the extent to which the nation’s overworked patent inspectors can be misled by applicants backed by big corporate war chests in pursuit of  billions of dollars in potential profits.

Legal experts have wrestled with that issue for years. “Catching fraud or other forms of cheating in the patent process is unlikely given the practical limits of the U.S. Patent and Trademark Office,” T. Leigh Anenson and Gideon Mark of the University of Maryland wrote in a 2013 law review article.

Often, courts have punished applicants who obtain patents through cheating by leaving the patents in place, but making them unenforceable by the wrongdoer.

That’s what Judge Freeman did — she barred Merck from collecting a dime from Gilead for the two patents it supposedly infringed. “People have referred to unenforceability as the atomic bomb of patent lit,” says patent expert Jacob Sherkow of New York Law School.

Merck itself alluded to the value of a strong patent system in announcing its court victory in March, when it spoke sanctimoniously about how the jury verdict “upholds patent protections that are essential to the development of new medical treatments.” A spokesman for the company reiterated the point last week in commenting on Judge Freeman’s ruling. But Merck insisted that the hepatitis C drugs at the heart of the case “required many years of research and significant investment by Merck and its partners.”

Freeman’s ruling has given Gilead the upper hand, for now, in trying to settle the dispute with Merck, which plans to appeal.

The evidence examined by Freeman strongly suggests that Merck flagrantly manipulated the patent process to gain unfair advantage.

Sovaldi and its related Gilead product, Harvoni, have been huge moneymakers for Gilead, bringing the company more than $20 billion in sales since the first drug was introduced in 2013. There’s no mystery why, since the drugs almost invariably cure hepatitis C with minimal side effects – a big improvement over previous treatments. The drugs are so effective that Gilead’s stratospheric pricing for them has become Exhibit A in the national controversy over the cost of drugs.

The case began in 2013, when Merck claimed that its patents covered Sovaldi and demanded royalties and license fees from Gilead. Gilead refused, and sued to declare Merck’s patents invalid. The trial jury  rebuffed that argument and ordered Gilead to pay Merck $200 million, plus future royalties – far less than the $2 billion that Merck had sought.

“That would have been the single largest patent damages award in U.S. history,” Sherkow says. Across the biotech industry, opinion was that Gilead got off easy.

But Gilead really drew blood when it accused Merck of coming to the patent battle with “unclean hands.”

Its claims stemmed from Merck’s interactions with Pharmasset, the New Jersey biotech firm that had invented Sovaldi and was acquired by Gilead in 2011 for $11 billion. Gilead’s story left Judge Freeman appalled.

She described the company’s behavior as “systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct.” That conduct included “lying to Pharmasset, misusing Pharmasset’s confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial.”

Much of the judge’s ire was directed at retired Merck patent attorney Phillippe Durette, who was working on patents for antiviral drugs during a period when Merck was trying to reach its own deal with Pharmasset.

Merck signed a nondisclosure agreement, or NDA, with Pharmasset, pledging not to use the latter’s secret information for any purpose other than to decide whether to pursue the relationship. Pharmasset turned over information including the structure of a key formulation to a single Merck scientist who was to be “firewalled” — that is, he couldn’t discuss it with anyone in Merck’s own drug development loop.

That worked until a March 2004 conference call between Merck and Pharmasset officials aimed at advancing a possible deal. Pharmasset was willing to reveal details of its formulas on the call, because it was led to believe everyone on the call would be subject to the confidentiality agreement. But the participants included Durette, who wasn’t firewalled and was in a position to turn what he heard into a potential goldmine for Merck.

According to Freeman, that’s what happened. Durette, who she said shouldn’t have been allowed on the call in the first place, should immediately have been excluded from Merck’s existing hepatitis C drug development program. Instead, he rewrote Merck’s earlier patent claims so that they would apply to Pharmasset’s upcoming release of its hepatitis-C drug.  In 2011, Merck even threatened Pharmasset with a patent lawsuit over the drug.

What irked the judge even more, she ruled, is that Durette lied.  In a deposition, he repeatedly denied having been on the call. He recanted at trial only after he was confronted with notes taken by a Pharmasset employee during the call, proving that he had participated. At that point, he pleaded a faulty memory.

Freeman didn’t buy it. “It is overwhelmingly clear…,” she ruled, “that Dr. Durette sought at every turn to create the false impression that Merck’s conduct was aboveboard.” She blamed Merck, which she said “sponsored and encouraged” his conduct, then sought to minimize its importance by attributing the fiasco to “the failed memory of a retired employee.”

Adding to the temerity of the big drugmaker, it originally sued Gilead for $2 billion before having to settle for $200 million. Now, pending appeal, it won’t get even that much for its patent claims, and its reputation for integrity will carry a value of less than zero.

Keep up to date with Michael Hiltzik. Follow @hiltzikm on Twitter

Find the original article post here

 

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