Tuesday, September 23, 2014

Are Generic Drugs Dangerous?

Generic drugs have long been pushed on American consumers as cost-effective alternatives to brand-name prescription medicines. But widespread manufacturing irregularities at drug factories overseas are raising troubling new questions about the safety of generics and whether they are putting Americans’ health at risk. 

A new analysis by the U.S. National Bureau of Economic Research reveals extensive problems with the quality of generics produced by Indian pharmaceutical companies, which supply about 40 percent of the generic drugs sold in the U.S. Bureau investigators examined nearly 1,500 India-made drug samples collected from 22 cities and found that up to 10 percent of some medications contained insufficient levels of the key active ingredients — concentrations so low, in fact, that they would not be effective against the diseases they’re designed to treat.
This new research adds to a growing body of evidence that the generic drug industry, which supplies 85 percent of the drugs sold in the U.S., routinely violates basic quality control standards and ships sub-par medicines to the U.S. and other countries. 
What that means is that many patients prescribed generic drugs are not only getting ripped off, but may not be at risk because their medications are not treating the conditions they have, says renowned cardiologist Chauncey Crandall, M.D.

Read Latest Breaking News from Newsmax.com http://www.NewsmaxHealth.com/Health-News/generic-drugs-danger-recall/2014/09/23/id/596332/#ixzz3E9IfRhwd
Alert: What Is Your Risk for a Heart Attack? Find Out Now

Knoxville-area clinics say they aren't affected by injectable warning from state health department

CLEVELAND (WATE) - State health regulators are telling people not to use certain injectable medications produced by a Chattanooga-area compounding pharmacy. The state says two clinics in the Knoxville area received drugs from the pharmacy, but those clinics say the drugs they use are not the ones that have inspectors worried.
The pharmacy at the center of this is the Wellness Store Compounding Pharmacy in Cleveland, Tennessee.
A state investigation found violations like out-of-date ingredients, unsupervised production of sterile products and falsification of records.
The products in question include prescription eye drops, steroids, vitamin B12, amino acids and hormones.
The state sent out a list of clinics known to have received injectable medications from the Wellness Store, including East Tennessee Vein Clinic of Knoxville and Premier Weight Management of LaFollette.
6 News spoke with both of them Monday. Both told us that they do not use the sort of medications listed by the state in the notice.
East Tennessee Vein Clinic of Knoxville said:"Our patients were not affected by any of the injectable medications in question."
Melissa Justice, owner of Premier Weight Management, told 6 News: "Everything we do is to the letter of the law and the highest standards of health care. We do not use that company anymore."
The state health department says the warning was issued out of an abundance of caution, and that it is not aware of any patients harmed by those medications.
Affected clinics, according to the Tennessee Department of Health:
  • Associates in Spine and Joint Medicine, Cleveland, Tenn.
  • Cleveland Medical Associates, Cleveland, Tenn.
  • East Tennessee Vein Clinic, Knoxville, Tenn.
  • Hollywood Body Spa, Athens, Tenn.
  • Internal Medicine Group, Cleveland, Tenn.
  • Kennedy Clinic, Ooltewah, Tenn.
  • Lynn Garden Weight Loss, Kingsport, Tenn.
  • Premier Weight Management, LaFollete, Tenn.
  • Voytik Center for Orthopedics, Cleveland, Tenn

Study shows inconsistent dosages of widely used eye disease drug

Custom-made versions of a widely prescribed, low-cost drug used to prevent a leading cause of blindness in the elderly vary widely in their dosages, Weill Cornell Medical College scientists found in analyses of the eye injections. Investigators saw no evidence of impurities or contamination but found that many of the samples, which were prepared by pharmacists through a process called compounding, contained less medication than doses of the drug obtained directly from the manufacturer. The research, published today in JAMA Ophthalmology, is likely to increase scrutiny of compounding pharmacies, which tailor-mix drugs for individual patients, and to question whether eye-care specialists should continue to prescribe the cancer drug Avastin for age-related macular degeneration (AMD).


IACP Launches Partnership for Personalized Prescriptions International Academy of Compounding Pharmacists

The International Academy of Compounding Pharmacists (IACP) announced today that it has enhanced its support of the compounding pharmacy profession with the establishment of the Partnership for Personalized Prescriptions.
The Partnership for Personalized Prescriptions or P3 is a new advocacy society that brings together over 150000 patients and practitioners who share a passion for compounding and are concerned about changes in prescription reimbursement programs that are increasingly threatening patient access to customized medicines.
P3 launched with a new website and social media channels on Facebook and Twitter which provide a forum for patients and practitioners to voice their support for compounding pharmacy or learn more about its important role in health care.
IACP is building on the association’s rich heritage of advocacy that began many years ago with the foundation of Patients and Professionals for Customized Care or P2C2.
“With the creation of the Partnership for Personalized Prescriptions we are expanding our original advocacy efforts and sharpening our tools to provide a strong platform to help raise compounding awareness as well as to restore the outstanding reputation of our profession” said Pat Stephens PharmD President of IACP and owner of Medi-Fare Drug an FDA-registered drug compounding outsourcing facility in Blacksburg S.C. “We encourage patients practitioners and pharmacists to join our effort to ensure continued access to personalized medicines.”

More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=99692#.VCGBK0uskUU#ixzz3E9GdQPN6

Knoxville pharmacists concerned as providers cut coverage of some compound medications

KNOXVILLE (WATE) - Some Knoxville area pharmacists are worried after a major prescription benefit provider is set to cut coverage for around a thousand drug ingredients commonly found in compound medications.
Some of those pharmacists are asking for patients to contact their employer's benefits office and urge them to keep their coverage for compound medicine.

Local pharmacists say Express Scripts has been cutting payments for some compound medications for the past several months. The cuts have been made in phases with the final phase occurring January 1.

Belew Drugs owner and pharmacist David Belew says his pharmacy has a lab dedicated to compounding medications. Each day, the pharmacy fills 300 prescriptions. About 10 of those will be compounded medications.

“We do a lot of compounding for children when commercially available products aren't made in the right dosage,” said Belew.

He's been paying close attention to policy changes related to compound medication coverage. He says several pharmacy benefits managers and insurance companies are cutting off payment for many compound medicines.

“The unwanted consequence of not covering these ingredients is that some patients who rely on compounded medications might not have access to those,” said Belew.

6 News contacted David Whitrap the Corporate Communications Director with Express Scripts and asked why the policy was changing.

He sent this statement reading in part "Some elements that are used to make compounded medications have been exorbitantly overpriced. If a patient truly needs a compounded medication covered by their plan, we will make sure they get it. But, by and large, compounded medications do not provide any additional clinical value over what is currently available. There are numerous FDA-approved or over-the-counter alternatives that patients can take."

Belew says there is waste in the health care industry, but blocking a thousand ingredients used to make compound medications isn't the best way to cut costs.

“There is going to be cost savings no question about that. Our real concern is that the cost savings comes at the risk of the patient's care,” said Belew.

Belew and other local pharmacists have been encouraging patients to contact their employer and opt out of the program cutting compound medications. Belew says if employers opt out though they may have to pay a higher premium since compound medications will continue to be covered.

The spokesperson for Express Scripts says 0.6 percent of their customers use compound medications.

He says the cost of the compound medication has been increasing exponentially with the average cost of compounded medication in 2012 being $90 to more than $1,000 now.

The price of pain: Indictments allege a massive compound cream scam

This is the third in a series on the compound cream industry. You can read Part One here andPart Two here.
Prosecutors in the Orange County District Attorney's office call it one of the largest cases they've taken on: 20,000 exhibits, 15 defendants and more than $100 million in alleged overbilling in an alleged workers' compensation fraud scheme centered around compound creams.
An Inland Empire businessman, Kareem Ahmed, is accused of masterminding the alleged scam. Prosecutors say he paid a dozen doctors, chiropractors and pharmacists a total of $25 million in kickbacks in exchange for writing, filling and billing for large numbers of compound cream prescriptions.
KPCC first reported on the indictments by the Orange County Grand Jury in June. The defendants are scheduled to be arraigned in Santa Ana on Friday.
What makes this case unusual was the volume of business, according to Assistant District Attorney Scott Zidbeck.
"We believe there were thousands of prescriptions being written and thousands being filled by multiple pharmacies in Orange County," and there were "huge markups billed to insurance companies," said Zidbeck. He said workers' compensation insurers would be billed in "the $1,500 to $3,000 range" for creams that had a wholesale cost of about $70.
Ahmed and three others formulated three creams based on the profitability of the ingredients, according to the indictments.
In California's workers' compensation system, a compound cream can be billed for every ingredient, which has been suggested as a reason why compound cream costs have skyrocketed.
Based on the high volume of prescriptions combined with the markups in price, prosecutors have calculated that participants in the case billed insurers for more than $100 million.
Compound creams are not approved by the Food and Drug Administration and are intended for limited use, typically for people who can't take oral medication. Prosecutors believe in this case compound creams were produced in bulk; federal law forbids their mass manufacture.
Zidbeck says the doctors involved in Ahmed's network were paid to participate. 
"They were given a financial incentive to write a prescription and refer that particular prescription to a certain pharmacy,"he said.

Top billers

Two of the doctors indicted for allegedly accepting kickbacks have been top compound cream billers, according to data from Los Angeles County.
In the three months spanning July-September 2012, Dr. Daniel Capen was number one in the county, the data show. Compound creams accounted for two-thirds of his prescriptions, and nearly 98 percent of the total amount of his billings.
Dr. Andrew Jarminski was the third top biller in the same time period, with creams accounting for 93 percent of his billings. 
Jarminski has declined comment. In an interview with KPCC, Capen said he thinks prosecutors went after him because of his volume of business.
"I don’t believe I committed any crime, nor did the other doctors," he said. "I think they targeted busier doctors."
Capen denied getting kickbacks in exchange for prescribing creams.
"It's not a kickback," he said. "I bought these creams, prescribe them to my patients and get remuneration, but doctors do that with injectables and other regular medicines."
Capen said he prefers compound creams because they are a less addictive option than FDA-approved narcotics.

Ahmed's attorney responds

In a written statement, Ahmed's attorney, Benjamin Gluck, said his client and the other defendants "never did anything wrong," and that he expects them to be "fully vindicated."
Gluck insisted that Ahmed's operation was completely legal. "Mr. Ahmed bought accounts receivable and billed those claims to insurance companies on letterhead showing his company’s name," wrote Gluck. "Each claim expressly set out the exact compound being used. Nothing was kept secret from anyone and every insurance company knew what it was paying for and why."
Internal emails from Ahmed's medical billing company, Landmark Medical Management, show some employees were concerned about the amounts of creams being produced.
In an email from May 2012 about another legal matter, a staff member wrote, "the problem will be that the compounds are not tailored [sic] made to every patient," and she added, "just look at our bills."
Gluck argued that there is nothing illegal about compounding drugs that are not tailor made for a patient. 
An illustration shows the alleged network of those indicted in June by the Orange County Grand Jury. (Photo courtesy of the Orange County D.A.)

FBI recordings

Among the 20,000 documents associated with the case are two FBI recordings that were made in 2010 as part of an insurance investigation involving businessman Cyrus Sorat, who eventually was convicted of mail fraud.
In October and December of 2010, Sorat wore a wire while eating lunch with Ahmed.
On the tapes, Ahmed can be heard boasting of his success: "I'm a behemoth, I make 8 to 10 million a month."
He also explained to Sorat how he marks up prices, while saying he does everything by the book. 
"It's the fee schedule man! You got to mark it up. It's like a 200 percent markup," Ahmed said. 
Ahmed also claims in the tapes that he had a hand in "shutting down" a bill in the state legislature that would have limited the reimbursements for compound creams.
"I shut it down for this year, the sleeping pile. AB 2779. Look it up, look what I did to it, what we did to it," Ahmed says.
Ahmed has donated well over $1 million to state and federal politicians and political action committees.
The recordings weren't part of the Orange County case and weren't presented to the jury that returned the indictments. Prosecutors say they’re holding on to the tapes, and will decide if they will be used as evidence at trial.
In response to the recordings, Gluck noted in his written statement that Ahmed "repeatedly told Mr. Sorat that he never pays doctors, he refused to enter a deal with a lab unless he knew it was legal."
Still, former FDA official Sarah Sellers is troubled by the nature of the conversations on the tapes.
"There is no evidence the practice of medicine is occurring," said Sellers. "There is no evidence that practice of pharmaceutical care is occurring. What is occurring is patients are being exploited as mere means for self-enrichment" said Sellers.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA keeps asking it to recall all of its sterile products, and NuVision Pharmacy keeps ignoring the request as it tests the limits of the FDA's authority over drug compounders. The FDA then warns healthcare providers they shouldn't use any drugs NuVision compounded, and NuVision tells customers that all is well.

The scenario is again playing out this week. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them. Included in the warning was a link to its letter to Dallas-based Downing Labs, which operates as NuVision, again asking the company to voluntarily recall its products and laying out a list of problems it said it discovered at the facility during an inspection that ran over 5 weeks in June and July.

The FDA said the inspection determined that 19 lots that were purportedly sterile drugs "tested positive for microbial contamination. In addition, three lots failed endotoxin testing." The FDA said that may be the result of poor aseptic filling processes and because APIs coming into the facility were contaminated with endotoxins.

But in a response on its website, NuVision said the 19 lots were never released. "We want to assure the public that the compounded lots with failed sterility and endotoxin test results were never released by our pharmacy. It is our policy to hold all compounded sterile products for a quarantine period of at least 14 days in order to wait for test results from a third party lab. Any products that fail sterility or endotoxin testing are investigated and destroyed by our pharmacy. These products are never dispensed to patients--we would be happy to provide all sterility results by our third party testing, as well as destruction logs of incineration, from our accredited third party for any lots in question."

The response goes on to outline a long list of changes it has made in response to FDA concerns. It has switched to an FDA-approved testing lab, changed gowning procedures and relocated and added HEPA filters in clean rooms. It said it is making changes that are outside the requirements of compounders to better serve its customers.

NuVision was among dozens of large-scale compounders caught up in a sweep by the FDA that began in 2012 after a fungal meningitis outbreak that killed 64 people was tracked back to a Massachusetts compounder. FDA Commissioner Margaret Hamburg was called on the carpet by Congress for not having a better fix on the situation. Because the compounding industry had fought federal oversight, the agency asked Congress for explicit authority to regulate the largest operators. Last year, Congress granted it some expanded powers: the authority to require certain standards and regularly inspect those companies which voluntarily sign up for oversight. Congress said then the market would punish bad players by giving business to those that are FDA approved.
So far, 56 sites out of more than 3,000 compounders have been registered. NuVision is not among them.