Showing posts with label Big Pharma. Show all posts
Showing posts with label Big Pharma. Show all posts

Saturday, October 29, 2011

My Son Is An Autistic Disorder Therapeutic Market Opportunity?

Pharma view of my son 



My view of my son

Apparently when pharmaceutical company executives contemplate the Autistic Disorder which limits the life of my son,  and the lives of many who suffer from the limitations imposed by Autistic Disorder, they see Autistic Disorder Therapeutic Market Opportunities, as described in thepharmaletter:

"The autism spectrum disorder (ASD) therapeutics market was valued at $3.1 billion in 2010 and is forecast to grow at a compound annual growth rate (CAGR) of 7.5% over the next eight years to reach $5.5 billion by 2018, finds GlobalData’s new report titled Autistic Disorder Therapeutics.

This market growth is primarily attributed to the high prevalence (0.6% to 1%) and prevalence growth rate (10-17%) of ASD in the US and in certain European countries. Co-morbidities such as anxiety, epilepsy and depression associated with ASD also contribute to the growth of the ASD therapeutics market.

...

Preference for educational/behavioral therapy over medication

GlobalData’s analysis suggests that educational/behavioral therapies such as Applied Behavioral Analysis (ABA) through environmental changes and behavior modification are the preferred treatment options for ASD patients. There are two approved drugs available on the market for the treatment of irritability associated with autistic disorder; while off-label drugs are prescribed to provide symptomatic relief only.

Therefore, behavioral therapy is the preferred treatment option over drug therapy. However, drug treatment is still required in certain physiatric disorders and with certain challenging behavior associated with ASD. Approximately 50%-70% people are prescribed drug therapy as behavior therapies alone are not always sufficient for managing the disease."

Translating from Pharma Speak ($$$) into one of the known human languages (English): pharmaceutical corporate profits should continue to rise with increases in Autism Spectrum Disorder diagnoses. Not to worry about ABA and other behavioral interventions ... "preferred" options ... depriving "pharma" (their expression not mine) of profits.

I hope pharma will forgive me. When I see my son I do not see an Autistic Disorder Market Opportunity I see a wonderful and amazing boy who has enriched my life in a way not contemplated in pharma newsletters.  I don't see $$$ when I see my son.  I see his amazing smile, his laughter, the joy he brings us each day.

Monday, May 09, 2011

Wheeling & Dealing & Avoiding FDA Scrutiny at the Vaccine Business Industry (Big Pharma) Congress



The vaccine industry business congress  referenced above states that it is scheduled for Baltimore in the fall of 2011 although the agenda indicates dates in March 2011.   More significantly the first items on the agenda show clearly the priorities of Big Pharma, as the conference brochure itself refers to the vaccine industry, which are maximizing government sponsored funding and avoiding FDA scrutiny.  Great stuff.

Yes, the Congress brochure does refer, several times, to Big Pharma, so don't go all Orac berserk on me for using that expression.

No word on whether  Offit, Orac, Mnookin or Deer were/will be in attendance.

Wednesday, September 23, 2009

Why the Big Pharma, Pro-Vaccine Cult is Losing the Vaccine-Autism War

Why prove to a man he is wrong? Is that going to make him like you? Why not let him save face? He didn't ask for your opinion. He didn't want it. Why argue with him? You can't win an argument, because if you lose, you lose it; and if you win it, you lose it. Why? You will feel fine. But what about him? You have made him feel inferior, you hurt his pride, insult his intelligence, his judgment, and his self-respect, and he'll resent your triumph. That will make him strike back, but it will never make him want to change his mind. "A man convinced against his will is of the same opinion still.

Dale Carnegie, How to Win Friends and Influence People


If you support vaccine programs as important public health tools then you are probably insulted, and not persuaded at all, by the title of this blog comment. If anything you will have dug in your heels in opposition to anything further that I might have to say. I doubt that Dale Carnegie would try to persuade people with opposing views to change their mind by insulting them.

Yet, that is exactly what is done every day by media editorial writers, bloggers and even health care professionals who dismiss parents concerned about vaccines being injected into their own children as hysterical. Anyone who asks questions about vaccine safety is branded as a nut, a hysterical parent, ignorant and ill informed, a conspiracy theorist etc. Is it any wonder that parents are not persuaded by such obvious attempts to marginalize them, to dismiss them and their concerns, to insult them?

Directly related to the use of insults to marginalize parents is the disregard for parents direct observation of what is happening to their children. Science, to this layperson anyway, must rely on actual observation as a basis for its method. No one has more direct, prolonged opportunity to observe their children then the parents who live with and care for those children. Yes, other issues arise because of the intensity of that emotional connection but the fact remains that it is parents, not Paul Offit, who actually observes their children, see them progressing and enjoying the milestones typically involved in infant development. It is parents who witness their children regress into autism disorders after vaccination that are in the best position to assess what has happened to their child.

The parents observations are, contrary to some statements that there is no evidence of vaccine autism links, exactly that. This direct observation does constitute evidence, albeit anecdotal evidence, that vaccines caused or contributed to their children's' autism disorder. Dismissing these observations as coincidence is not persuasive unless YOU can prove that it is a coincidence.

There have been a number of epidemiological studies done which are used to argue that science has conclusively disproved a vaccine autism link. Yet those studies have been subjected to what appears to be valid criticisms. The Danish study is perhaps the most notorious example. It compared autism rates before and after thimerosal was removed from vaccines in Denmark, Yet the study itself points out that the comparisons were questionable because of the different groups examined in the different time frames. The Danish study looked at autism rates in the period from 1972-2000. As everyone knows who argues against a real increase in autism rates, the diagnostic criteria for autism changed in the early 90's making it difficult to draw firm conclusions from that study. Perhaps equally as negative about the Danish study is that it was conducted after serious prodding by American health authorities who wanted to dispel a vaccine autism connection.

The epidemiological studies are observational. They do not test an hypothesis in a controlled experiment. No observational studies of vaccinated and unvaccinated populations have been conducted despite existing unvaccinated populations and despite calls for such a study from parents and professionals concerned about possible vaccine autism connections. Dr. Insel did not persuade any persons with vaccine and autism concerns that vaccines are not connected to autism when he appeared before Senator Harkin's committee and declared that an observational study comparing autism rates in vaccinated and unvaccinated populations could not be done. His statement was directly contrary to those of Dr. Bernadine Healy (former NIH head), Dr. Julie Gerberding (former CDC director) and Dr. Duane Alexander, a member of the IACC to the effect that such a study COULD be done. Dr. Healy and Dr. Gerberding have both said that such a study SHOULD be done. When public health authorities refuse to undertake credible research to examine the vaccine autism issue and yet state to the media that the matter is closed, that science has determined the issue conclusively and for all time, their credibility is undermined, their ability to convince concerned parents is weakened.

Dr. Healy, in calling for more research on vaccine autism issues, has pointed out that the epidemiological studies are not specific enough to address vulnerable population subgroups. The Poling case is a perfect example of the validity of that criticism. Not all people are constructed the same. The effect of a vaccine on one person may not be the effect of a vaccine on another. In the Poling case autism resulted from the impact on the child's mitochondrial disorder. Dr. Healy has called for a variety of studies to examine further the vaccine autism issue. Yet her name rarely appears in media summaries of the issue which prefer to paint the issue as Jenny McCarthy against the scientists.

If public health authorities want to restore public trust in vaccines they should do the research that Dr. Healy has called for. They should conduct the observational study comparing existing unvaccinated and vaccinated populations and stop pretending that it can not be done. They should stop pretending that science has conclusively decided the issue when too many people know that not to be true and refuse to be bullied and intimidated. Public health authorities should not be afraid to do more homework to ensure that the chemical and biological concoctions they are insisting people inject into their children are safe in all instances.

If public health authorities want to restore public trust in vaccines and convince us all that vaccines do not cause or contribute to autism they should stop condescending. They should start treating parents like what they are in this matter ... the front line researchers whose observations are invariably the first stage in recognizing and understanding autism disorders in their children. They should start treating those parents with the respect they deserve. Their failure to do so to date has been the biggest reason why they are failing to convince some parents that vaccines are safe. It is the biggest reason the public health authorities are losing the battle to restore public confidence in the safety of vaccines. If you don't believe me, check with Dale Carnegie. He left us with some notes on the subject.




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Saturday, December 20, 2008

Autism Smearing on Autism Street, Yes Virginia (Do'C) Conspiracies Do Exist


Autism Street is not a blog I recommend to parents seeking balanced, objective information about the realities of autism cause, cure or treatment.

"Autism" Street is a member of the "Autism" Hub, a group of blogs which embrace the concept that autistic disorder, a neurological disorder, is actually a blessing to be celebrated. It has an ideological approach to discussion of autism issues and can be snide and nasty to those who disagree with the Autism Street views of autism.

Proponents of the various vaccine/autism theories are often targets on Autism Street. Rumors that members of Generation Rescue were to appear on CNN's Larry King prompted Autism Street's owner Do'C into a full scale tizzy and with unabashed glee Doc immediately set out to smear the anticipated guests, thereby pre-emptively dismissing what they might have to say, by painting them as "nutjobs" in his December 20 comment The Lure Of Conspiracy.


The tool used by Do'C, in his smearing of Generation Rescue, was an article about the attraction of conspiracy theories, The Lure of Conspiracy Theories, by Dr. Patrick Leman. Apparently Dr. Leman is conducting research into a mindset or type of reasoning which characterizes conspiracy adherents for whom conspiracies exude a seductive appeal. On this flimsy basis Do'C suggests that Larry King ask the anticipated guests "a real question":

“What would you say to those people who might refer to you as conspiracy theorist nutjobs with your claims that vaccines cause autism and that the government is covering it all up?”

Ah, now I see Do'C. Anyone who suggests that governments might cover up health hazards is a "nutjob" right? Thanks Do'C, now everyone can stop worrying. Unfortunately, in the real world, outside the brick walls of DoC's Autism Street ideology, conspiracies actually do exist and governments have in fact covered up, or failed to disclose, serious health risks.

In Canada our Competition Act, Criminal Code, National Defence Act and Security of Information Act all contain sections setting out offences described as conspiracies. It is my understanding that in the United States similar prohibitions against conspiracies exist, including in the RICO Act. These conspiracy sections, and other sections dealing with fraud, do not exist because of the whims of legislatures. They exist because fraud and conspiracy are, unfortunately, part of the fabric of criminal activity in any society.

Here in the Province of New Brunswick our people were shocked by the charging, trial and conviction of several prominent directors of a public hospital on multiple counts of defrauding a hospital corporation of funds. One of the directors involved in R. v Stymiest was, until his conviction, a sitting Provincial Court judge. In the sentencing decision Mr. Justice Stephen J. McNally stated at paragraphs 14 and 15:

[14] It seems clear that detection of the frauds was also avoided for so long due to the high professional and social status enjoyed by the perpetrators of the frauds. Mr. Stymiest was a sitting Provincial Court judge while the other accused were senior executives of the hospital who were well respected and thought of highly in the hospital and larger community of the Miramichi. Mr. Tucker was the president and Chief Executive Officer of the hospital. He was described as a hard driving manager who was able to get things done. Both Mr. Stymiest and Mr. Tucker were strong willed and imposing personalities which would no doubt cause the average person to think twice before suggesting any improper or even questionable conduct on their part.

[15] Fortunately, good people often rise well above the “average” and due to the tenacity and courage of a few volunteer members of the board who persisted in asking questions and demanding answers, despite the defendants’ positions and responses to the questions; the frauds were eventually investigated and criminal charges instituted.


But Do'C already knows that conspiracies do in fact exist in the real world. Surely he has heard of ENRON? Maybe Do'C is too busy smearing Generation Rescue to have stayed abreast of the news of Bernard L. Maddof's world wide Ponzi scheme?

For DoC's information the Tobacco Industry has been the target of many conspiracy investigations, charges and some convictions:

The defendants in the case were:


* Philip Morris Companies (now Altria)
* R.J. Reynolds Tobacco Company (RJR), now Reynolds American
* Brown & Williamson Tobacco Corporation (BW), now part of Reynolds American
* Lorillard Tobacco Company
* The Liggett Group
* American Tobacco (now part of Reynolds American)
* British American Tobacco Industries (BATCo)
* The Council for Tobacco Research (CTR)
* The Tobacco Institute, Inc.


Specifically, the Department of Justice (DOJ) alleged that the cigarette industry has purposely and fraudulently misled the public about the risks and dangers of cigarette smoking. The government alleged that "the Defendants have engaged in and executed – and continue to engage in and execute – a massive 50-year scheme to defraud the public, including consumers of cigarettes, in violation of RICO". [Taken from DOJ Final Proposed Findings of Fact (FPFF), Executive Summary, page 1.]

....

Conviction

After 6 years of litigation, 9 months of trial, hundreds of depositions and thousands of exhibits, on August 17, 2006 U.S. District Court Judge Gladys Kessler ruled that the Government had proven its case and found that the tobacco company defendants have violated the Racketeer Influenced Corrupt Organizations Act (RICO).

Final Findings

Based on the evidence presented in the case, Judge Kessler ruled that:

* Defendants knew for fifty years or more that cigarette smoking caused disease, but repeatedly denied that smoking caused adverse health effects. Defendants publicly distorted and minimized the hazards of smoking for decades.

* Defendants concealed and suppressed research data and other evidence showing nicotine is addictive, and withheld information about their internal research on addiction, from the American public, the government, and the public health community, including the United States Surgeon General. The Defendants acted this way to maintain profits by keeping people smoking and attracting new consumers, to avoid liability, and prevent regulation of the industry.

* Defendants falsely denied that they can and do control the level of nicotine delivered to smokers to create and sustain addiction.

* Defendants falsely marketed and promoted low tar/"light" cigarettes as less harmful than "full flavor" cigarettes to keep people smoking and sustain corporate revenues.

* From the 1950s to the present, different tobacco companies using different methods have intentionally marketed cigarettes to young people under the age of 21 in order to recruit "replacement smokers" who would ensure the future economic viability of the Tobacco Industry.

* Defendants publicly denied, while internally acknowledging, that secondhand tobacco smoke is hazardous to nonsmokers.

* At various times, Defendants attempted to, and did suppress and conceal scientific research and destroy documents relevant to their public and litigation positions.

The existence of other conspiracies does not prove a claim that government and industry have colluded and conspired to conceal evidence or information showing that vaccines, or vaccine ingredients, cause or contribute to autism cases. Personally I am not convinced that such a case of conspiracy has been established. I also have no doubt though, on the evidence, that public health authorities have in the past discouraged investigation of a possible vaccine/autism connection.

The fact that some people allege the existence of conspiracies does not, as DoC insinuates, mean that they are "nutjobs" whose views should be dismissed. Mr. Justice McNally's comments in R. v Stymiest are worth remembering when contemplating DoC's smear job of the Generation Rescue people and their beliefs. They are not "nutjobs" as DoC clearly insinuates. They are good people rising well above the "average".

They are trying, against the powerful weight of public authority, and sometimes cheap, nasty internet commentary, to right what they believe to be a wrong. And time might well prove them right.




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