Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, April 13, 2020

Could "wildly inaccurate tests" be outcome of ant-body experiment?


The FDA says anti-body tests could be inaccurate if not watched carefully...

Digital generated image of macro view of the corona virus. (Getty Images)
Calling it the “Wild West” of unregulated tests, yet still...
"Because of the relative simplicity of the technology, the Food and Drug Administration decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak."
Shouldn't there be some kind of oversight when we are talking about a disease that has already killed almost 22,000 Americans? Or are we again dealing with one of those situations where Donald Trump wants things to go unchecked so he can involve his donors and himself in some kind of corrupt money-making machine scheme? It has Trump exploitation written all over it. Here's the scenario...
"Right now, the tests are most useful for researchers studying how the virus has spread through the U.S. population. The government said Friday it has started testing 10,000 volunteers. The White House has not outlined a broader plan for testing and how the results might be used.
"With almost no FDA oversight of the tests, “It really has created a mess that’s going to take a while to clean up,” said Eric Blank of the Association for Public Health Laboratories. “In the meantime, you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is.”
Good explanation of anti-body tests...


Blank’s group represents state and local lab officials from around the country who want more hands-on by the FDA instead of just requiring the company to "state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected." The FDA responded...
"Last week, FDA Commissioner Stephen Hahn said in a statement that the agency will “take appropriate action” against companies making false claims or selling inaccurate tests."
Sure, and that's like the old saying of 'closing the barn door after the cows are already out.' It's too late if someone has a false negative and dangerous for the individual. Here's confirmation of that...
"Dr. Allison Rakeman of New York City’s Public Health Laboratory says some local hospitals are assuming the tests, which are listed on FDA’s website, 'have been vetted, when they have not.'
"The danger of faulty testing, Rakeman says, is that people will mistakenly conclude that they are immune or are no longer spreading the virus."
Once again the Trump administration has created a mess, and once again it is the American public who suffers.

You're on Progressive Street...Where Liberals walk...

Monday, January 2, 2012

Drug companies want to convince you that you are sick

Americans are going without necessary drugs to fight major aliments like cancer with no alternative available according to a new report, while pharmaceutical companies play with a new business model that emphasizes profitability.  Lipitor was the culprit when it went generic and its maker, Pfizer, was faced with losing the $13 billion in annual revenue.  The current model of betting on everyday afflictions required high priced screening programs that took up to 15 years to reach success, and requiring enormous facilities and numbers of people.

Not sure what was wrong with the old model since over the last 20 years, drug companies have been the world’s most profitable.  Pfizer, itself, is ranked 21st in the Fortune 500 with sales of $8.257 billion in 2010; Johnson & Johnson was 9th; Eli Lilly was 29th; Abbott Laboratories was 33rd.  But Scott Gottlieb writing in the Wall Street Journal says, “There’s something unanticipated in drug research that can’t be industrialized.”  The new focus of drug makers are the more serious conditions such as cancer and Alzheimer’s.

Pharma pushing drugs
The concentration is now on more finite accuracy over wide-scale experiments, but much depends on government regulation.  The Federal Drug Administration (FDA) is not known for being the best at what it does, although it is the only game in town.  Gottlieb comments, “Regulatory requirement have grown enormously over the past few decades, increasing costs and deterring new investment.  But it would seem that we are being led to believe that, in spite of being the highest profit industry in the world, drug companies should be pitied.

The same report says that if pharmaceutical companies were forced to report potential shortages to the FDA in a timely manner, the agency could find alternatives to deal with the issue.  Like the situation 61-year-old Renee Mosier faced with her ovarian cancer this past June.  She needed the drug Doxil, which has no generic equivalent, and has not been available for several months.  It is a life and death thing for Mosier, particularly since this is a recurrence of her cancer.  Currently there is no legislation requiring the reporting of shortages.



But the above isn’t even the worst of a pharmaceutical industry gone bonkers.  Ever hear of disease mongering?  It’s a term that’s been around 20 years and refers to the way drug companies promote their blockbuster drugs to those who are “sick.”  Lynn Payer, author of Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick, lists four disease mongering tactics:

  • taking a normal function and implying that it is potentially dangerous and should be treated, preferably for a long time
  • taking a common symptom that could mean anything and making it sound as if it is a sign of a serious disease    
  • saying that a large percentage of the population might be suffering from the “disease”
  • recruiting doctors to spread the message

To me the last one is the most alarming, assuming some docs would recommend a drug just because the salesman is pushing it because the company wants to promote it at all costs.  And Dr. Andrew Weil adds yet another contrivance: allocating a clinical-sounding name to what is really an everyday malady like heartburn, which becomes “gastro-esophageal reflux disease or GERD.”  In the article done by David Wallechinsky, he says, “Aggressive and creative marketing has permitted drug manufacturers to convince millions of people they have a problem that requires treatment and medication.”  Like depression.

But when depression became passé, pharmaceutical companies switched to adult ADHD (Attention Deficit Hyperactivity Disorder).  ADHD cases skyrocketed; doubling, even tripling among important age groups 20 to 44 and 45 to 65.  Disease mongering has also led to “cooked up” diseases like female sexual dysfunction leading over 60 percent of women to think they had it.  Pfizer even tried promoting Viagra to women until it was proven it was no more effective than a placebo. 

Wallechinsky adds, “Sometimes, the therapy being pushed can be more harmful than the condition it’s supposed to treat.” Like exploiting rheumatoid arthritis with immune suppressors such as Remicade, Enbrel, and Humira.  “Taking these, however, can ‘invite cancers, lethal infections, and activate TB [tuberculosis],’” according to Martha Rosenberg at AlterNet. 

There’s more to be said about the shenanigans of large pharmaceutical companies like shady lobbying and how they use your personal data that I will cover in a later post.  In the meantime, isn’t it nice to know that these big corporations have the consumer’s best interest at heart, and that we have the FDA to protect us if something happens?  Yeah…right!

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