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I reserve the right of editorial censorship
Posted on January 30, 2020 by Pharmaciststeve
It looks like the political “mud slinging” has already started – IMO – worse than the national election two years ago… I am taking a stand – in particular – against “slanderous name calling” directed toward specific politicians, particular political parties and/or specific people. I don’t mind political debate – based on FACTS… when the debate drifts off the road based on FACTOIDS, FAKE NEWS, opinions stated as FACTS.. is where I am going to draw the “line in the sand” and delete comments that go down that path.
While personally, I am not a big fan of our political/bureaucratic system.. IMO.. it is too self serving… Admittedly, politically I tend to lean to the POLITICAL RIGHT but that is because the Libertarian party is seemingly always kept in their place by our dominating “two party system”.
I have belonged to a national pharmacy association for 35 yrs… that promotes the saying “get into politics … or get out of pharmacy ..” If you don’t attempt to influence politicians… someone else will…. and IMO this saying applies to those in the chronic pain community and/or pts who are dealing with subjective diseases. Legislatures, bureaucrats are doing things that are adversely effecting the quality of life of those pts. As long as those being affected continue to lack unity and/or a large segment chooses to stand on the sidelines, whoever is successfully “bending the ear” of these politicians … they will continue to do so because they have little/no concern about the consequences and/or collateral damage that they cause to those suffering and dealing with subjective diseases.
I am sure that the vast majority of my readers will understand and cooperate…those who try to challenge this policy… It is THREE STRIKES and you are out/banned… and WORDPRESS gives me your IP ADDRESS attached to your comment(s)… Once banned, just posting under a different name – WILL NOT WORK ! Everyone needs to “play nice “
Lastly, please do not post anything promoting a particular vendor or any entity or person selling a product/particular service. Because some may perceive/believe that they have my endorsement which may or may not be the case. Anyone posting a link to a professional selling a product/service will be edited out
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Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products – available by mid-April
Posted on January 29, 2020 by Pharmaciststeve
Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products
Insulin manufacturers are continuing efforts to provide more cost-savings options to patients with diabetes.
Today, Eli Lilly announced new plans that include 50% lower list prices for certain insulin products that will be available by mid-April
according to a company press release. This will include lower-priced versions of insulin lispro protamine and insulin lispro injectable suspension 100 units/mL (Humalog Mix 75/25 KwikPen) and insulin lispro injection 100 units/mL (Humalog Junior KwikPen).
Lilly initially introduced its first lower-priced insulin, insulin lispro injection 100 units/mL, in May 2019 at a 50% lower list price than the branded version.
Combined, these 3 insulin products comprise of more than 90% of prescriptions written for a mealtime insulin manufactured by Lilly, according to the release. Insulin lispro injectable suspension 100 units/mL, in particular, is one of Lilly’s most prescribed insulin, with approximately 600,000 prescriptions filled in the last 12 months, Lilly said.
The announcements comes after Novo Nordisk also recently introduced its new insulin cost-savings options for patients experiencing difficulties affording their medications. These plans include short-term free, immediate supply for patients in urgent need with a prescription and a $99 purchase program. Novo Nordisk also offers authorized generic versions of their NovoLog and Novolog Mix.
According to Lilly, the lower-priced version of Humalog Mix75/25 will be known as Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (100 units/mL). The lower-priced version of insulin lispro injection 100 units/mL will be known as Insulin Lispro Injection Junior KwikPen (100 units/mL). Both prices will have a list price of $265.20 for a package of 5 KwikPens.
“The cost of insulin at the pharmacy varies dramatically depending on a person’s insurance coverage,” Mike Mason, president, Lilly Diabetes, said in a statement. “These lower-priced insulins may reduce out-of-pocket costs, especially for people in the coverage of Medicare Part D, the uninsured or those with high-deductible insurance plans.”
The Kwikpen contains 3 ml of U-100 insulin so the “5-pak” will be equivalent of 1.5 vials of insulin and resulting an equivalent cost of $176.8/ 10 ml vial.
When this was initially announced a few months back… Lilly stated that NO REBATE/DISCOUNT/KICKBACK to PBM would be made and many/most/all PBM’s responded that this generic insulin would be a “non covered item”… Discounts/Rebates/Kickbacks to the PBM have been reported to be upwards of 75% of the wholesale price of a particular med.
These price reductions by Lilly and Novo Nordisk suggests that they were being forced to “share” around 50% of their insulin revenue to various PBM’s in order to keep their insulin products on the PBM’s approved formulary.
If I was a diabetic and the pharmacy was told that a Rx for these products were “non-covered”.. I would investigate how the pt could submit a claim for reimbursement, they just might reimburse for the medication. If the pt is not reimbursed, it might be advisable to contact the pt’s members of Congress. It would seem unlikely that Lilly’s generic insulin is INFERIOR to Lilly’s brand name insulin.
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The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines
Posted on January 27, 2020 by Pharmaciststeve
FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations
https://www.news-line.com/PH_news30087_enews
The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.
Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte, as well as dietary supplements Mello-Tonin and Body Mass Reset and device Energy FX among others. Basic Reset and Biogenyx issued recall notices by email to their customers on Sept. 23 and Oct. 18, requesting disposal or return to the place of purchase for products sold, purchased or distributed after Nov. 7, 2017. Given these products do not comply with appropriate FDA standards, they have the potential to be unsafe or ineffective for their particular uses, and could lead to adverse health impacts. The FDA is reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products as they do not meet FDA regulations.
“The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs and medical devices are safe and effective for their intended uses and that dietary supplements are manufactured and distributed appropriately,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. “All companies must follow the appropriate standards and are given the opportunity to ensure their actions are in accordance with these laws. We will continue to prevent the distribution of products that do not comply with applicable FDA requirements and ultimately place the public health at risk.”
Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded.
This action follows multiple FDA inspections conducted at Basic Reset and Biogenyx between 2012 and 2017 and a 2016 warning letter. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the companies failed to make the necessary corrections. Basic Reset, Biogenyx and the other defendants cannot receive, label, hold or distribute dietary supplements, drugs or devices until they take certain steps to ensure that all of these products comply with the law. Operations can only resume after receiving written permission from the FDA.
The FDA has not received any adverse event reports related to these products. The FDA encourages patients and health care professionals to report any adverse events to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
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Dr. Thomas Kline, MD, PhD: Myth 13: Everyone should go to a pain clinic
Posted on January 27, 2020 by Pharmaciststeve
https://youtu.be/pIsiSltSYPk
I suppose every one should go to a sore throat clinic, The most frequent reason for a doctor’s visit is pain. If doctors can’t treat pain, they need a new line of work. 80% of docs in the US are too timid to prescript pain medicine, so they send them to pain clinic, where only 1/3 are treating with pain medicine. Most are under treated, or not treated. Only 13% said good treatment, and 25% with little treatment. CDC gave licence to steal by prescription unneeded urine drug tests and dubious injection mills. 90% have said pain medicine are more effect than injects. 44% said care was worse at pain clinic than doc’s office. 92% of patients wouldn’t Recommend pain clinics.
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Dr. Thomas Kline, MD, PhD: Myth 12: Alternatives to pain medicine are safe and effective
Posted on January 27, 2020 by Pharmaciststeve
The center for disease control, aka the CDC,published guidelines, march 15 2016, attempting to override FDA prescription doses. Without proper authorization, CDC attempted to declassification opioids pain medicine as the drug of choice, as it has been for 50 centuries. They admitted this was based on no or low scientific research, and was based on consults from PROP, an anti-opioid pain medicines group. They recommended alternatives that do not work, and have greater cost and side-affects. One of their prime alternatives, Gabapentin, a seizure medicine, now reporting to cause overdose deaths, just recently.
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Dr. Thomas Kline, MD, PhD: Myth 11: Addiction and Dependency are the same thing
Posted on January 27, 2020 by Pharmaciststeve
False, they are not the same thing, by any means. we need a new word for dependency. It’s like snow, and there are many types. The main dependency that is confused is the one that is during drug withdraw. The new word is biochemical interdependence.
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Is that a Centipede I see in my Capsule ?
Posted on January 25, 2020 by Pharmaciststeve
What’s going on at the FDA? 10 agency updates
Posted on January 20, 2020 by Pharmaciststeve
What’s going on at the FDA? 10 agency updates
https://www.beckershospitalreview.com/pharmacy/what-s-going-on-at-the-fda-10-agency-updates.html
The FDA is a government agency tasked with protecting public health by making sure prescription drugs are safe and efficient.
In the last couple of months, several studies have been published questioning how the agency does its job, a new commissioner took over and the agency created a program to improve drug quality.
Ten FDA updates reported by Becker’s Hospital Review since December:
Editor’s note: This is not an exhaustive list. Events are listed in order from most to least recent.
- FDA approvals relying on weaker evidence, study finds
While the FDA has gotten faster at approving new drugs, it is relying on weaker evidence in granting those approvals. - FDA warning letters to devicemakers down nearly 90 percent
The number of warning letters the FDA sent to medical devicemakers fell by almost 90 percent between 2015 and 2019, and it could be because the FDA is too focused on pleasing the device industry. - FDA, NIH allowed clinical trial sponsors to keep results secret
Institutions that conduct clinical trials — such as pharmaceutical companies and universities — do a poor job following a law that requires them to post clinical trial results on a government website, and the government agencies that are supposed to enforce that law are ignoring it. - JAMA editorial blasts FDA’s reporting of medical device problems
The FDA needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an editorial published in JAMA Internal Medicine. - FDA rush to meet drug approval deadlines doubles adverse patient effects, study finds
More drugs are approved in December than any other month, but end-of-year approvals are associated with twice the number of adverse effects, including hospitalizations and deaths. - FDA creates Center of Excellence program to improve compounded drug quality
The FDA formed the Compounding Quality Center of Excellence program to mitigate quality issues with compounded drugs. - Senate confirms Dr. Stephen Hahn as FDA chief
Stephen Hahn, MD, became the latest FDA commissioner after the Senate voted 72-18 to confirm him. - Decline in number of FDA inspections raises concerns about safety of pharma supply chain
The number of FDA inspections of drug manufacturing facilities has declined, partly because of a lack of inspectors, raising concerns about the safety of the global pharmaceutical supply chain. - Rapid FDA drug approvals raise patient safety concerns
The FDA has been approving new drugs so quickly that some patient safety advocates are voicing concerns. - Serious drug side effects likely underreported to FDA, study finds
Underreporting prescription drug side effects may be much more common than previously thought.
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Government-sanctioned medical torture, pain treatment, the health care industry, and bodily autonomy
Posted on January 19, 2020 by Pharmaciststeve
Recorded by the Libertarian Party on 6-23-19. Press release referenced in video: https://www.lp.org/libertarians-suppo… Dr. Kyle Varner is a practicing hospitalist and expert in health care policy. In his upcoming book, White Coat Cartels, Dr. Varner uncovers the dark side of the US healthcare market. Dr. Varner passionately stands for freeing the market and advocates cash-based services and medical tourism as the prevailing alternatives to the compromised healthcare system we are faced with today. He is a highly sought-after writer and speaker, and has spoken at a number of conferences around the world. He shares his insider’s knowledge on the website DrVarner.com to give people the tools they need to take back control of their lives and start making informed decisions about their health. Cara Schulz is a Stage 4 cancer survivor and advocate for humane pain management for cancer patients and chronic pain patients. She has testified on their behalf at the Minnesota State Legislature and is a co-founder of Minnesota Pain Initiative. The Libertarian Party hosts a series conference calls on topics ranging from outreach, activism, current issues, and important updates on our party’s progress. After visit on Health Blog you will get all the details related to health.
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