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

Sunday, January 26, 2020

The evil in your medicine



About a week ago, I listened to the podcast of Peter Attia, MD, with Kathrine Eban, the author of the book Bottle of Lies. It was one of the longest podcasts Attia has produced, and yet, I could not stop listening. It was a captivating and anxiety-inducing narrative about generics, the cheaper version of the brand-name medications.

As the minutes turned into hours, the discussion revealed the depths of a global crime with the main motivation being the GREED. 


After the podcast, I obtained the book and read it in three days. Several times through the book, I started crying (yes, I am a cry-baby). Several times, I had to stop reading because the words felt like punches to my chest and left me breathless. I was facing one of the most detailed and harrowing accounts of EVIL.

And here is some of the story.

First was the GREED of global pharma. The drugs were developed based upon huge intellectual and research effort, and yes, based upon lots of funds. But the profits exceeded the expenses beyond any imagination. The drug prices that pharmaceutical companies extracted from the patients and the US health system supported the companies’ manicured headquarters and campuses, the lavish caviar-and-champagne office parties, the helicopters and the multi-million-dollar salaries and bonuses of the executives.

The second layer of GREED story was revealed when the pharmaceutical companies in China and India were allowed to deliver the cheaper versions of the brand-name medicines – the generics. The lower price, however, compromised the quality of the medications. As noted in Kathrine Eban’s book, each drug is a poison, and its therapeutic range is rather narrow. Anything outside this range could damage or kill. If to the not-so-precise dosing of the generics, one adds impurities, carcinogens, fast degradation/decomposition or deregulated bioavailability of the active ingredients, then the result is a generic drug that acts as a placebo (the best case scenario), or functions as a lethal weapon. 


The death of the pharmaceutical manufacturing in the USA, the rise of pharma in India and China, the resulting genocide in the form of substandard or murderous generics, and the inability (unwillingness?) of the federal government to address this genocide are all documented in Bottle of Lies.

If you, your family and friends rely on any medication, you should listen to the podcast of Attia and read the book
Bottle of Lies.

What can you do when prescribed and dispensed a generic medication that might make you sicker, kill you or is just ineffective?

I hate to say that there is no hope or solution to this tragedy. But for most people who are not aware of what is happening, there is no solution. Many patients would end up poisoned or even killed by the medications. 


And yet, you may try to fight the established system by insisting that your doctor and pharmacy give you the brand version of the medicine. It will certainly cost you.

There is also the very first online pharmacy Valisure, that analyzes for reliability all drugs they dispense. They also keep a list of Indian and Chinese companies that they would never order drugs from. Learn more about this company from another podcast of Dr. Attia, this of his conversation with David Light.  


Finally, eat healthy, move, destress so that your dependence on drugs is decreased. Above all, read the book, be aware. Let your friends and family know the truth.


If you live in Europe, you will find this video revealing and troubling:  How Safe Are Our Medicines.

Saturday, June 16, 2018

Repurposing Old Drugs For New Roles

Here is an interesting article about expanding the use of old, approved drugs for new purposes.  In theory, this is a good idea, since the safety profile of the drug and its various side effects would already be known, and sometimes “side effects” can mean the drug can be useful against other disorders than originally intended.  However, this requires additional testing to determine if the drug is actually effective in the new role for which it is being proposed. The problem is that when you consider expensive drugs still under patent, pharmaceutical companies have a patent incentive to do such testing, but not for low-cost generic drugs. The author proposes some ways around this: government funding, prize funds, leveraging existing data.  Given the cost of new drugs and the uncertainty of side effects, particularly long-term side effects, once they are in clinical use, repurposing old drugs has promise in being more safe and efficient.  From the article:

US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications to expand the market for the product. For example, the tyrosine kinase inhibitor imatinib (Gleevec; Novartis) was originally approved to treat Philadelphia chromosome–positive chronic myelogenous leukemia, but has since been approved for treatment of other cancers. Many noncancer drugs also follow this pattern, including botulinum toxin A (Botox; Allergan), which was originally approved for the treatment of strabismus and blepharospasm and subsequently approved for treatment of cervical dystonia, cosmetic uses, and chronic migraine.
This pattern of additional testing and approvals is common for more expensive on-patent drugs, but new indications are rarely sought for less-expensive generic drugs, for which it is more difficult to profit from the research. This creates a policy conundrum: follow-on innovation for low-cost generic products offers a rare opportunity to simultaneously improve health outcomes and likely reduce health care expenditures, but how could such research be encouraged?

Friday, April 13, 2018

A Bizarre Story For Friday The Thirteenth


A Southern Illinois University professor is being investigating for allegedly injecting people with an unauthorized vaccine for herpes.
The FDA is investigating William Halford for administering his experimental vaccine to patients without safety oversight from the organization or an institutional review board. Halford, who died in June, gave participants the vaccine in St. Kitts and Nevis, islands in the southern Caribbean, in 2016, and in Illinois hotel rooms in 2013, Kaiser Health News reported.
The professor, 48, gave the vaccine to at least 20 herpes patients in St. Kitts and Nevis and to at least eight herpes patients at a Holiday Inn Express and a Crown Plaza Hotel near his research lab at the university in Carbondale, Illinois.
Authorities are uncertain where Halford manufactured the vaccine.
Now, the FDA's Office of Criminal Investigations is looking into whether people at Halford's former company, Rational Vaccines, or Southern Illinois University had knowledge of his actions and violated FDA regulations by assisting him in unauthorized research, four people familiar with the situation told Kaiser Health News.
Although the FDA rarely prosecutes research violations, the agency may move forward with this case and pursue the unauthorized development of the vaccine as a crime. These violations are severe because Halford is not a medical doctor and provided an experimental vaccine without supervision, which is a possible violation of human-subject guidelines.
The university told Kaiser Health News it's cooperating with the FDA's investigation and admitted Halford violated university rules and the law. However, university officials deny any knowledge of his actions and say they are not responsible, the sources said.
Rational Vaccines did not comment. The company assisted in the Caribbean trial but was not founded at the time the hotel-room injections occurred.

Tuesday, November 28, 2017

The FDA And Vasopressin

The FDA got involved in trying to regulate marketed previously unapproved drugs, with results perhaps not unexpected to those of us who have taken a MBA-level course in economics.  From the (publicly available) paper linked above:

In May 2017, the US Food and Drug Administration (FDA) announced a Drug Competition Action Plan, designed to address competition and pricing in the generic market and improve access to prescription drugs. One of FDA’s stated goals is to reexamine “places where its rules—including standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access,” instead of ensuring the vigorous competition Congress intended. In this Viewpoint, we examine FDA’s 2006 Unapproved Drugs Initiative (UDI), designed to strengthen the agency’s regulatory oversight related to unapproved marketed drugs. Using an illustrative example, we discuss this initiative’s unintended consequences, as it appears to have created obstacles to generic drug access, likely increasing prescription drug costs…On November 14, 2014, Par received FDA approval for Vasostrict, and on December 15, 2014, FDA instructed all other suppliers of unapproved intravenous vasopressin to stop manufacturing their products by January 30, 2015, leaving only Par with a marketed product. Subsequently, the average wholesale price of intravenous vasopressin increased from $4.27 to $138.40 per vial in November 2016, a 3141% increase. In 2013, when there were multiple competing suppliers, total sales from intravenous vasopressin approximated $4 million. As of November 2016, Vasostrict achieved annualized sales of nearly $400 million. As a result of the high cost, reports have surfaced of vasopressin being removed from code carts, making it unavailable in life-threatening situations.

I’ll leave it to the reader to ponder whether the vast increase per vial price for vasopressin was a justifiable change, and whether the unavailability of this drug for endangered patients is somehow compatible with the FDA’s ostensible mission.

The FDA and Big Pharm: a match made in heaven…or hell.  You decide.  Look at the facts reported in the paper and the other link and ponder well.


Tuesday, November 22, 2016

Psychotropic drugs


What do you think is more harmful to humanity: tobacco use or prescribed psychotropic drugs? After watching this documentary, I would say that both tobacco and psychotropic drugs might cause equal harm.

The difference is that no one prescribes you cigarettes, it is your own decision to use or not use tobacco.

However, the use of psychotropic drugs involves a criminal offense. It is an offense perpetrated by the pharmaceutical companies producing the drugs, the FDA approving the drugs, and the "doctors" who prescribe the drugs. You are simply the victim. Do not be one. Watch the documentary.


The drugging of our children is also discussed, and I have written about it earlier. Do not subject your kids to this injustice. Watch the documentary.

Monday, November 23, 2015

If you are sick, would you trust a sick health care system

Let me answer the question. Let us say, I am diagnosed with cancer – would I trust our health care? I am unsure. The problem is that the health care system is sick itself. In addition to the pitfalls of the U.S. healthcare system, the U.S. Food and Drug Administration (FDA) seems to be dispensing placebo and toxins, rather than effective anti-cancer drugs. The shocking realization is that many FDA-approved cancer drugs do not work. A recent publication in the Journal of the American Medical Association is the source of this sobering realization. Here is what the authors wrote:
 

Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival. Enforcement of postmarketing studies is therefore of critical importance.
 

Actionable
Dear FDA, researchers and profiting pharmaceutical companies, please stop pumping pseudoscience into the oncology clinics. By doing so, you are giving ammunition to the alternative cancer treatment proponents. No wonder that the recent Ty Bollinger’s documentary on cancer was watched by more than 800,000 people within the first month of its release on Internet. Laced with some anti-establishment emotions, this documentary contains a few true messages and warnings about our conventional cancer care. The ludicrously expensive new anti-cancer drugs that kill the patients and bankrupt their families, the blatant ignorance of our oncologists about diet and its effects on cancer initiation and progression, the stubborn refusal to research and incorporate century-old remedies, are all ammunition in the hands of the alternative cancer care network. The documentary is an absurd mixture of ignorance and truth that leads us to the denial of any conventional cancer therapy. The vehement negation of the values in the two systems – the conventional cancer treatment and its alternative counterpart  - is the wrong way to go. We should be able to extract the best of both approaches and integrate them. Above all, in our fascination with curing cancer, instead of preventing the birth of the enemy (i.e., the initiation of cancer), we are fighting the enemy at its optimal power (i.e., when the cancer is already established and has advanced). Although prevention is the best path, It seems that no one (mainstream or alternative cancer care proponents) is interested in following this direction.
 

And to answer my initial question: if I cannot prevent my cancer, if I am a cancer patient one day, I will seek a highly integrated cancer care system that includes the best of the mainstream and alternative medicine.