Wednesday, March 30, 2011

Hall Of Shame; Pharmaceutical Companies and HCV oh my!

Hall Of Shame

Pharmaceutical Companies and HCV

Remember When ????
In November of 2010 Roche was fined for offering money to a nurse working at a undisclosed clinic. Kate Hagan from writes "Drug company Roche has been fined $200,000 for offering to fund a nurse's position at a health service - depending on how many patients were treated with its hepatitis C drug Pegasys"The drug company has two fines under (two different occasions) the Medicines Australia code of conduct for the maximum of 200,000 dollars. This summer a French doctor working as a consultant for "Human Genome Sciences Inc. was charged by the U.S. with insider-trading for allegedly tipping off a hedge fund about negative results of Albuferon drug trials."

In October of the same year Sam Waksal, the former CEO of ImClone Systems, whose insider trading lead to spending time in prison along with Martha Stewart, remember? Announced a new enterprise; "Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise".

Let's not forget the list published on the 384 doctors and healthcare professionals who were paid by pharmaceutical companies to promote their drugs. They "Drew Payments From Drug Companies" for the amount of no less then $100,000 published @ ProPublicas website: This list covered "Top Earners from 2009 and early 2010"

The Johnson  &  Johnson Dilemma;

Johnson   &   Johnson who is in late stage trials of hepatitis C drug TMC435 and as we know has a hand in Vertex/Johnson  & Johnson/Mitsubishi Tanabe's drug telaprevir, sure has seen better days.
Lets begin with their plant in Las Piedras, Puerto the FDA’s website back in November found these problems; as noted here,  "Distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff..
Thus far the company has recalled millions of bottles of Tylenol, Motrin and other products manufactured in Puerto Rico."

Ft. Washington, Pennsylvania Plant The Back Story;

Recalls; January 14, 2011
The Januray recall affected certain lots of Tylenol, Benadryl and Sudafed products because of insufficient cleaning procedures, though the company does not believe that quality was impacted. The company also recalled certain lots of Rolaids tablets because they do not include certain labeling information. All of the products were made at the company's plant in Fort Washington, Pa., before it was shuttered in April following a Food and Drug Administration investigation. FDA inspectors found a slew of manufacturing problems at the plant, including equipment covered with thick layers of dust and others held together with duct tape. J  &  J issued several recalls related to the problems, the largest of which involved more than 135 million bottles of infants' and children's Tylenol and other medicines.

The Shut Down

In may McNeil Consumer products shut down the Ft. Washington  factory, FDA found these problems, quoted from this article "Among other problems, FDA inspectors said some manufacturing equipment was covered with dust, and others was held together by duct tape. The company did not have laboratory facilities to test drug ingredients. The agency says its inspectors found bacterial contamination in some raw materials. They declined to name the type of bacteria, saying they "didn't have enough information in yet. The FDA says there is no indication of contamination in the finished products."

From Pharmalot ; The plant is now being retooled and under careful watch as part of a consent decree (see this, this and this).

Just  yesterday Reuters reported that  Johnson   &   Johnson, is recalling more of its over-the-counter Tylenol products. The company said it was recalling over 700,000 bottles or packages of Tylenol and other consumer medicines made at a now-closed plant, the latest in a litany of recalls by the company.
The company product was made at its Fort Washington, Pennsylvania plant before J   &  J closed the facility in April 2010.


On March 28 Johnson  &  Johnson's Ethicon unit is recalling a group of medical drainage products because of concerns about the sterility of the products.
Misleading Letter
A jury in South Carolina on March 25 found Johnson   &  Johnson's pharmaceutical unit, Ortho-McNeil-Janssen, guilty of misleading doctors about the safety and effectiveness of the anti-psychotic drug Risperdal. It seems a Johnson  &   Johnson unit violated consumer-protection laws by sending  South Carolina doctors a misleading letter about the safety and effectiveness of the antipsychotic drug Risperdal.
From The Famous TV News Show 60 Minutes

The Tale of a Whistleblower: How One Pharmaceutical Giant Was Brought to Its Knees

November of 2010 we discovered that one of the world’s largest drug manufacturers, a subsidiary of GlaxoSmithKline, wasn’t really looking after our well being at all when it distributed adulterated drugs. However, it appears they had an eagle eye on the money. They would’ve likely gotten away with what appears to be gross negligence, too, were it not for one whistleblower. More than likely medications tainted with bacteria, labeled incorrectly, or not the correct strength would have continued to make it to our pharmacies. However, thanks to a tip from a company insider, Cheryl Eckard, a federal investigation ensued and Glaxo has had to pay up

Pharmaceutical Hall Of Shame 2011

The lawsuit was initially filed by former BMS employees - Michael Wilson, who was a sales rep; Lucius Allen, who was a cardiovascular metabolic risk specialist; and Eve Allen, who was an integrated health manager. They alleged the drugmaker instructed its reps to woo docs with expensive meals; theater and concert tickets; honoraria; liquor; gift cards; golf outings; all-expense-paid trips to resorts and samba dances (for Hispanic physicians) to induce them to prescribe more meds. One popular freebie: suites at the Staples Center to watch Los Angeles Laker basketball games, food included.

An FDA chemist named Cheng Yi Liang was charged today by the US Securities and Exchange Commission with insider trading on confidential info about upcoming announcements of 27 different FDA approval decisions involving 19 publicly traded companies and generated more than $3.6 million in illegal profits for himself. And would you believe that he avoided incurring any losses?

Some of the FDA announcements involved approval of new drugs while others concerned were negative decisions. In each instance, the SEC says he traded in the same direction as the announcement, but worked hard to disguise his work. Beginning in July 2006, Liang traded in seven brokerage accounts, including six listed in the names of other people, including his 25-year-old (who was also charged) and his 84-year-old mother who lives in China......

Sonova Holding AG (SOON) said its chairman, chief executive and finance chief are resigning their posts after a delayed profit warning prompted an investigation into possible insider trading at the Swiss hearing-aid maker.

Chief Executive Officer Valentin Chapero and Oliver Walker, Sonova’s chief financial officer, have handed in their resignations, the Staefa, Switzerland-based company said in a statement today. Chairman Andy Rihs will also step down from his post while remaining on the board, Sonova said. The board appointed Robert Spoerry as its new chairman. Alexander Zschokke will be interim CEO.

Merck The Company Behind The Investigational HCV drug Boceprevir

By GOSIA WOZNIACKA, Associated Press
Associated Press March 29, 2011 06:23 PM Copyright Associated Press.
 Tuesday, March 29, 2011

Company officials failed to alert residents and collect data about groundwater, air and soil contaminated with cancer-causing chemicals from a Central California manufacturing plant owned by a former subsidiary of drug maker Merck & Co., lawyers for nearby residents told jurors Tuesday in closing arguments of a lawsuit.

Attorney Mick Marderosian, who represents 2,000 plaintiffs, said the defendants — Merck & Co., Amsted Industries Inc., Meadowbrook Water Co. and Baltimore Aircoil Co. Inc. — didn't alert a Merced housing community directly across the street from the plant about contamination from hexavalent chromium, the chemical made famous in the film "Erin Brockovich."

Triad Prep Pads;

By JoNel Aleccia
Health writer

updated 3/28/2011 6:30:10 PM ET 2011-03-28T22:30:10

The federal Food and Drug Administration is asking a Wisconsin firm tied to infections and death blamed on contaminated medical wipes to voluntarily stop making and distributing its drug products, has learned.

The move is aimed at halting operations at H  & P Industries Inc., which does business as the Triad Group of Hartland, Wis., said Michael C. Rogers, the FDA's acting director of the Office of Regional Operations. It comes at the conclusion of an intense, week-long inspection that concluded Monday, Rogers said.

"We have evidence that shows this firm made and distributed products with a variety of opportunistic pathogens," Rogers said.

In a statement, H&P Industries officials confirmed that they had been contacted by FDA about "manufacturing of products not covered by previous recalls." A company spokeswoman, Christy Maginn, would not say whether the firm will stop operations.

"At this time, they're still in discussions with FDA," Maginn said.

The cease-and-desist request follows a series of news reports about inspections at the Triad Group plant and massive recalls of alcohol prep wipes, povidone iodine prep wipes and lubricating jelly all suspected of bacterial contamination.

The alcohol wipes, which were recalled for potential contamination with the bacteria Bacillus cereus, have been blamed for several serious infections and the death of a 2-year-old boy in Houston.

The Back Story

H & P Industries, the parent company of the Triad Group, has issued a voluntary recall of all lots of providine idodine prep pads

March 19 2011
New Recall: All lots of povidine iodine prep pads manufactured by H  &  P Industries Inc.

As of March 15th
H   &  P Industries, the parent company of the Triad Group, has issued a voluntary recall of all lots of providine idodine prep pads. The notice from H  &  P stated the pads may be contaminated with "Elizabethkingia meningoseptica", an organism that has caused rare but serious infections in humans, including, pneumonia in patients on ventilators and necrotizing fasciitis, more commonly known as flesh-eating bA and meningitis in newborn infants. As noted in the press release from H & P now on the FDA's website the new recalled prep pads include povidine iodine prep pads made by H&P Industries packaged under the names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety and Total Resources.

"Agency 'very concerned' about iodine pads tainted with dangerous bacteria, official says"
See The Press Release From H & P Here

Feb 22 2011 

USA: FDA knew of problems with Triad's tainted alcohol wipes Roche said "Triad pads are distributed with several drugs including the Boniva bone-building drug and hepatitis C treatment Pegasys."

Merck said "Triad pads were distributed with Pegintron, a treatment for hepatitis C, and a related drug, Intron A, outside the U.S. Merck said drugs distributed in the U.S. aren't affected."

Merck issued a warning about the recalled pads to customers who use Pegintron (peginterferon alfa-2b) single dose RediPen and Pegintron vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and Intron A (interferon alfa-2b) Multidose RediPen and Intron A solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Triad:

Off The Cuff

U.S. NEWS MARCH 29, 2011 Secrets of the System


PORTLAND, Ore.—Dr. Vishal James Makker had already operated on Ronald Johnson's spine six times in less than two years, but he had some grim news for the former machine-tool operator: X-rays showed Mr. Johnson needed a seventh surgery.

Mr. Johnson, 62 years old, says he had felt progressively worse after each operation. He told the doctor he was done with surgeries.

Dr. Makker took a second look at the X-rays and changed his tune, Mr. Johnson recalls. "Actually, you're going to be all right," he says Dr. Makker told him, adding that he had been looking at the films wrong.

At that moment, Mr. Johnson became the latest in a string of patients to grow suspicious about multiple surgeries performed on them by Dr. Makker, a handsome, 41-year-old neurosurgeon with a charming bedside manner..
Pharmalot  is a great site to read while you drink that morning cup of coffee, what a way to start the day .
Pharmalot offers ; "Commentary on the pharmaceutical industry and related litigation."
I would like to mention how grateful I am to both J  & J and Merck for bringing us Telaprevir/Boceprevir.
Although the pharmaceutical industry as a whole have their problems, I personally hope these  two drug companies remain  financially stable and continue to embark on new investigational drugs to treat HCV.
I continue to have faith in both companies and assume/pray  they will continue in their effort to find a cure for HCV.
Well, also folks we have; Achillion ACH-1625 ,   PSI-938 and PSI-7977 and other drugs making their way down the pipeline, waiting for more good news from the EASL meeting.
Thats My Bottom Line
Enjoy The Day !


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