Authentic Journalism involves the opinion of all involved and an argument presented. Since the introduction of electronic news services on the internet , the major newspapers have struggled with their business model of advertising dollars being utilized to underwrite good journalism. Papers fell before and after the fact that subscription and advertising rates fell.
To counter the lack of capital flow local newspapers have resorted to yellow journalism to sell more papers and subscriptions. Instead of attacking a corporation or a bank for money laundering, or for unconventional medical models of health care delivery ,individuals are attacked requiring 1000s of dollars to reverse slander . The companies that supply the drugs are never questioned and neither are the compounding pharmacies. I have been a victim of this incomplete picture being presented while the Houston Chronicle and hence all of the local news agencies are not involved in the proper reporting of all aspects of certain topics. They stay away from the big boys. Some of the players who were under surveillance at the same time I had disparaging articles written about me, were never mentioned by the Houston Chronicle. given the chance for rebuttal I can show medical electronic records for each pill prescribed as well as physical exams I addition the records of several patients who were treated for opiate addiction with Clonidine.
Here is part of an article commenting on issues in Florida with one flowing showing the results of a law going into effect today eliminating possibilities to obtain oral opiates. It is a Prohibition placed of opiates . The ONLY result will be increased heroin sales in the US.
Please note that in England Heroin addicts are treated for free , I am not sure if they even utilize Methadone. England nevertheless has a problem with opioid addiction to pills as well as overdosages which plague certain areas in England.
Abbott run-in with Indian regulators illustrates India's shortcomings: Reuters
Authorities call out Abbott product for exceeding codeine levels but refuse to provide sample that Abbott suspects is a fake
Some months ago, Indian regulators posted a notice that a couple of batches of an Abbott ($ABT) cough syrup was defective, that it contained twice the level of codeine is allowed by law. But the episode, which has been going on for about 9 months, is turning out to be less about flaws in the drugmaker's manufacturing practices than about the flaws in India's system of oversight.
Reuters in an exclusive story reported that a state lab in West Bengal posted the notice last February after Indian regulators confiscated some bottles of what they said were Abbott's Phensedyl, a popular product that accounts for a third of the cough syrup market. When Abbott tested its batch samples, however, it were found to be in compliance. Months after asking India to provide one of the samples so it could determine if it was a counterfeit, it has yet to get one. Two different authorities each insist it must be obtained from the other.
"We are awaiting response from the authorities," the company told Reuters in a statement.
Sign up for our FREE newsletter for more news like this sent to your inbox!India currently has about 1,500 inspectors to oversee an estimated 10,000 drug manufacturing facilities. Under pressure from the West, it has pledged to spend about $263 million in the next three years to hire and train inspectors and to add to its laboratories. But in the meantime, it has taken few if any steps against any its large domestic drugmakers that the FDA has often found fault with, while companies like Abbott find themselves defending their reputations over issues that they may not even be responsible for.
The cough syrup products in the Abbott case were taken near the border of Bangladesh, according to a state inspector. Reuters reports that because products containing codeine are banned in Bangladesh, they are often counterfeited and smuggled into that country.
Navneet Marwaha, the drug controller in the Himachal Pradesh, acknowledged that counterfeiters often target the cough syrup market, and that Abbott has been able to account for all of its product. "They (Abbott) are saying 'show us the sample so we can see whether it is genuine.' They have not been provided with the sample," Marwaha said.
Marwaha said it was up to West Bengal authorities to provide the information to Abbott but authorities there say they have neither the time nor the resources to follow up and that the they can't hand over the sample without approval from Himachal Pradesh. They also said the drugmaker would need a court order to get it. In the meantime, Abbott has left the product in the market.
Shortcomings in India's regulatory system became front and center several years ago when former FDA Commissioner Margaret Hamburg during a visit to the country urged government and industry leaders to do more to upgrade manufacturing quality and oversight. Indian regulators have taken few, if any, steps against Indian drugmakers with which the FDA has had repeated problems. The agency has banned products coming out of plants of Ranbaxy Laboratories, Sun Pharma, Wockhardt and others after finding they had faked data to indicate that batches that failed certain test standards were good enough to be shipped to the U.S. Indian authorities in the past have said they looked over these facilities but never found anything that warranted stopping production. They claimed Ranbaxy's finished products met Indian requirements.
Under mounting pressure, including from lost exports, the government is taking steps to do better. The Central Drug Standard Control Organization (CDSCO) is doubling its inspector headcount to 1,000 and has been sending trainees on plant visits with international inspectors, including from the FDA, so that they can learn to evaluate the facilities as the Western inspectors do.
- read the Reuters story
Related Articles:
India sending inspectors on facility visits with global peers
Indian authority withdraws Ranbaxy plant export permit
Indian regulators punch up standards as FDA action takes a toll on the industry
Reuters in an exclusive story reported that a state lab in West Bengal posted the notice last February after Indian regulators confiscated some bottles of what they said were Abbott's Phensedyl, a popular product that accounts for a third of the cough syrup market. When Abbott tested its batch samples, however, it were found to be in compliance. Months after asking India to provide one of the samples so it could determine if it was a counterfeit, it has yet to get one. Two different authorities each insist it must be obtained from the other.
"We are awaiting response from the authorities," the company told Reuters in a statement.
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The cough syrup products in the Abbott case were taken near the border of Bangladesh, according to a state inspector. Reuters reports that because products containing codeine are banned in Bangladesh, they are often counterfeited and smuggled into that country.
Navneet Marwaha, the drug controller in the Himachal Pradesh, acknowledged that counterfeiters often target the cough syrup market, and that Abbott has been able to account for all of its product. "They (Abbott) are saying 'show us the sample so we can see whether it is genuine.' They have not been provided with the sample," Marwaha said.
Marwaha said it was up to West Bengal authorities to provide the information to Abbott but authorities there say they have neither the time nor the resources to follow up and that the they can't hand over the sample without approval from Himachal Pradesh. They also said the drugmaker would need a court order to get it. In the meantime, Abbott has left the product in the market.
Shortcomings in India's regulatory system became front and center several years ago when former FDA Commissioner Margaret Hamburg during a visit to the country urged government and industry leaders to do more to upgrade manufacturing quality and oversight. Indian regulators have taken few, if any, steps against Indian drugmakers with which the FDA has had repeated problems. The agency has banned products coming out of plants of Ranbaxy Laboratories, Sun Pharma, Wockhardt and others after finding they had faked data to indicate that batches that failed certain test standards were good enough to be shipped to the U.S. Indian authorities in the past have said they looked over these facilities but never found anything that warranted stopping production. They claimed Ranbaxy's finished products met Indian requirements.
Under mounting pressure, including from lost exports, the government is taking steps to do better. The Central Drug Standard Control Organization (CDSCO) is doubling its inspector headcount to 1,000 and has been sending trainees on plant visits with international inspectors, including from the FDA, so that they can learn to evaluate the facilities as the Western inspectors do.
- read the Reuters story
Related Articles:
India sending inspectors on facility visits with global peers
Indian authority withdraws Ranbaxy plant export permit
Indian regulators punch up standards as FDA action takes a toll on the industry
P&G joins Pfizer and Abbott in fighting India's cough med ban
Wednesday, March 16, 2016 | By Eric Palmer
Indian regulators over the weekend included some popular cough syrups containing codeine in a drug ban in what was deemed an effort to tighten up the nation's supply chain of opiates to fight smuggling and drug addiction. But the action by the Drug Controller General of India (DCGI) has unleashed a firestorm from Western drugmakers that dominate that market.
Abbott ($ABT) joined Pfizer ($PFE) in turning to the Indian Supreme Court for a stay on the ban, and Procter & Gamble ($PG) has said it was looking into that option. The DCGI over the weekend banned 344 fixed-dose drugs, claiming they did not have approval from the central government and lacked therapeutic justification. But the meds have been sold for years after getting approvals from local states.
Pfizer's Corex and Abbott's Phensedyl each control roughly a third of the $103 million market in India for cough suppressants with codeine. P&G sells Vicks Action 500 Extra, which is a fixed-dose combination of paracetamol, phenylephrine and caffeine, Reuters reports.
The government has been talking about a ban and has taken steps over the last few years to limit the manufacture and sales of the codeine-based drugs. They have said the steps were needed to make it harder for smugglers to divert codeine for illegal use and to fight the country's opiate addiction issues, Reuters reported last year. Both Pfizer and Abbott previously reduced their manufacturing runs after government rules limited sales to one batch per buyer. They also changed labeling to indicate on the label where products were to be sold to help regulators better track the meds.
From Bloomberg Business
George typically charged his walk-in patients $200 for the first visit, and $150 a visit thereafter. He says about half his revenue in the pain clinics came from such consultation fees. The other half came from buying opioids wholesale and then reselling them at a markup. In most states, after a patient gets a prescription for painkillers from a doctor, he then has to go to a pharmacy. Not so in Florida in 2008, when George was launching his business.
From the get-go, George wanted to sell painkillers directly from his clinics, but he needed someone to sell him the pills. Due to the legal and public-relations risk of handling large amounts of opioids, people in the business tend to be tight-lipped about their suppliers, especially with people they don’t know. At first, George checked out the major national pharmaceutical wholesalers, such as Cardinal Health, AmerisourceBergen, and McKesson. He soon realized that was a dead end. The top distributors had too many rules, he says. To take one example, according to George, they refused to sell you an order that was 100 percent controlled substances. At least half the order, he says, had to be other medications. George had no way of reselling large amounts of, say, aspirin. It would crimp any potential profits. “They were tough to get set up with,” says George. “I tried. It was too much of a pain.”
Eventually, hunting around online, George found a list of businesses in Florida that had DEA registration numbers. The list didn’t specify which were retailers and which were wholesalers. So George had an employee sit down, call every business, and ask whether they sold controlled substances to medical clinics—and if so, under what conditions. Before long, George had identified a couple of potential regional dealers. From there, says George, it was surprisingly easy. “All I had to do when I started was call up a wholesaler, say I had a medical office, and fax in the doctor’s DEA registration and medical license,” says George. “Then I would basically tell them what I wanted, send in the order forms, and they’d ship to me. They didn’t know who I was. They didn’t talk to the doctor. I could have been someone with a doctor’s stolen information. There is really little due diligence.”
George soon learned one of the quirks of the opioid market. In most wholesale negotiations, the more you buy, the less you pay per unit. With opioids, the inverse is true. The more opioids you order, the more a wholesaler will charge you per pill. “It’s backwards from a normal free market,” says George. That’s because the more a wholesaler agrees to ship to someone like George, the higher the risk that it will trigger a red flag at the DEA. As a result, the wholesalers have to be cautious when dealing with new clients.
Opioid crackdowns often start with a tip from a wholesaler. On Sept. 29, 2010, agents at the DEA office in New Orleans received a phone call from D&H Wholesale Medical in Ruston, La. According to court documents, the wholesaler reported to the DEA that a new customer with no established relationship had just tried to order 20,000 oxycodone pills. The tip triggered an investigation. In the fall of 2011, DEA agents raided more than a dozen businesses, homes, pain clinics, and pharmacies around Atlanta and arrested multiple individuals for their alleged involvement in a racketeering conspiracy to illegally sell large amounts of oxycodone.
George says that as his business in Florida expanded, he struggled to buy enough opioids to keep up with the demand. His stable of almost a dozen wholesalers ranged from tiny local operations, such as Medical Arts Pharmacy in St. Petersburg, to a couple of national distributors, including Harvard Drug Group, based in Livonia, Mich., one of the 10 largest wholesalers of generic drugs in the country.
George guarded the names of his wholesalers from the hundreds of other pain clinics that were popping up in Florida. In retrospect, George says the reason he was able to operate with such volume is because he forged more deals with more wholesalers than his competitors. “I worked real hard at getting wholesalers and keeping them secret,” says George. “That’s why we were able to buy so many more pills than other pain clinics. We did a lot more work in finding out who was selling the medication.”
When the cops descended on American Pain and its sister clinics in the spring of 2010, several wholesalers found themselves in trouble for selling to George. Among the defendants was Steven Goodman, the owner of Medical Arts. Earlier this year, Goodman pleaded guilty to one count of conspiracy to defraud the U.S. He is currently awaiting sentencing. His lawyer declined to comment.
On June 15, 2010, the DEA suspended Harvard Drug’s license to distribute controlled substances on the grounds that the company had endangered public safety by selling oxycodone to pain clinics in Texas and Florida—including American Pain and Executive Pain. In response, Harvard Drug filed suit against the Department of Justice seeking injunctive relief. According to Harvard Drug’s complaint, the company already had in place a “suspicious order system,” designed to monitor orders for controlled substances and, on average, was faxing the DEA five warnings a day. The company argues that in January 2010—months before the DEA revoked its license—Harvard Drug had reached out to the DEA, specifically seeking guidance about whether it was OK to sell oxycodone to the pain clinics in question. In April 2011, Harvard Drug announced on its website that the company had reached a settlement with the federal government resolving all of the DEA’s claims. Harvard Drug admitted no wrongdoing and agreed to pay an $8 million fine. Chief Executive Officer Terry Haas, who joined Harvard Drug in January 2011, says the company has stopped selling oxycodone in the U.S.
In the meantime, recent court cases show that pharmaceutical wholesalers continue to be vexed by what they describe as ambiguity at the DEA. In February, the DEA suspended Cardinal Health’s license to ship controlled substances from its distribution facility in Lakeland, Fla., alleging that the company had endangered public health in part by selling enough oxycodone to two CVS Caremark pharmacies in Sanford, Fla., to supply a population eight times the city’s size. The move came just a few years after Cardinal Health settled over similar allegations from the DEA, paying a $34 million fine in 2008 without admitting liability. This time, Cardinal Health promptly filed suit against the federal government seeking relief.
Lawyers for the Healthcare Distribution Management Association (HDMA)—a trade group for wholesalers—filed a brief in support of Cardinal, arguing that the system for policing wholesalers is broken and that the DEA has “failed to provide meaningful guidance” to wholesalers.
In May, Cardinal Health settled with the DEA, agreeing to halt shipping of controlled substances from the Florida facility for two years. In the meantime, the fog surrounding opioid distribution lingers, creating enough uncertainty in the market for retailers like the George twins to accumulate vast amounts of oxycodone in a piecemeal fashion by cobbling together smaller orders from a network of wholesalers, each unaware of what the others are doing. In the absence of a centrally maintained database of the sales of controlled substances, some distributors, like Harvard Drug, have decided it’s no longer worth the risk of participating in the market.
Gary Boggs, special agent with the DEA’s Office of Diversion Control, says the cases that the DEA has brought in recent years involved wholesalers knowingly making enormous sales to customers that were, per se, in violation of DEA rules. “The notion put out by HDMA that somehow or another the DEA is not providing essential information to them is simply not accurate,” says Boggs. “It’s a smoke screen. It’s a step out of desperation.”
George, too, says he is being unfairly punished for regulatory shortcomings. When George got into the business, Florida was one of 15 states in the country without a statewide prescription-monitoring program (PMP). It has since put one in place. According to the Alliance of States with Prescription Monitoring Programs, 48 states now have legislation authorizing a PMP, and 41 states currently have PMPs that are operational. Such databases are typically designed so that a retailer can type in a patient’s name and see if that individual has recently filled prescriptions for painkillers at other clinics or pharmacies.
George says that in the absence of a state system there was no way he and his employees should be held responsible for failing to differentiate between legitimate patients and reckless purchasers going from doctor to doctor to stock up on painkillers to resell on the street. George also says he doesn’t see how he can be held criminally responsible while the majority of the wholesalers who dealt to him have avoided criminal charges. “I don’t understand how they’re not way more responsible than me,” says George. “I’m serving 18 years for it, and they’re not even in jail.”
NOTE THAT TEXAS DOES NOT EVEN HAVE A BLUE STRIPE. I MAY HAVE PRESCIBED AT THE MOST 30 OXYCODONE TABLETS TOTAL.
According to IMS Health, there are 92 different oxycodone-based medications currently on the market in the U.S. and another 218 containing hydrocodone. Only a few are patented. George says he and his brother steered clear of brand-name opioids. He once accidentally ordered Percocet, a brand-name opioid, from a wholesaler, when he meant to order generic endocet. Otherwise, he avoided medications like OxyContin, Opana ER, or Vicodin—which generally belong to a parallel world where patients have health insurance, physicians worry about ethical prescribing, industry-funded nonprofit groups advocate for the right of doctors to prescribe opioids to patients in pain, and glowering U.S. senators occasionally broadcast their disapproval.
The George brothers operated downmarket from all of that. They bought and sold the generics. Their customers paid in cash. At his clinics, doctors typically prescribed around 180 30-mg painkillers per patient at $2 apiece plus a small amount of generic anti-anxiety medication such as alprazolam. George says the wholesalers usually sold him generic roxies for, on average, around 70¢ a pill. Thus each sale netted roughly $1.30 profit per pill, or about $235 for every prescription they filled on site. For brand opioids, on the other hand, says George, wholesalers charged about $3 a pill. “Nobody buys brand,” says George. “Especially when it comes to roxies. I don’t even know who makes the brand Roxicodone.”
Instead, George says he sold about a half-dozen kinds of generic roxies, including ones marked “A/215,” which are made by the Actavis Group, a multinational generic drug manufacturer headquartered in Zug, Switzerland; “V-4812,” manufactured by Qualitest, a pharmaceutical company based in Huntsville, Ala., which Endo Pharmaceuticals purchased in 2010; and “K-9,” created by KVK-Tech, a private company in Newtown, Pa. In general, he sold whatever he could buy in the largest amounts from wholesalers. The most common form of roxy they sold were little blue generics, labeled “M/30.” George suspects customers liked them the most because they were the easiest to crush up, mix with water, and inject.
Called “mallies” by aficionados, the M/30s are made by Mallinckrodt, a pharmaceutical company founded in Missouri in the 19th century. Mallinckrodt is now the pharmaceuticals business of Dublin-based Covidien, a global health-care products maker with $11.5 billion in annual revenue. According to the company’s website, Mallinckrodt is currently the ninth-largest manufacturer of generic pharmaceuticals in the U.S., with more than 90 million prescriptions dispensed annually. In an e-mail, Stephen Littlejohn, Mallinckrodt’s vice president for communications, says the company has less than 20 percent of the market share of 30-mg oxycodone tablets and that “we believe that reducing the abuse, diversion, and misuse of powerful pain medications is necessary to ensure adequate treatment of pain and access to that treatment for legitimate pain patients.”
There may be plenty of consumer demand for prescription painkillers in America, but it still pays to advertise, says George. When he was first breaking into the industry, what went on in a strip-mall pain clinic was basically unknown. George bought ads in the yellow pages. He took out ads in a local alternative weekly paper, the New Times Broward-Palm Beach, alongside promotions for strip clubs and escort services. “Eventually all the pain clinics put ads in there,” says George. “People would know that if you wanted to find one, you just pick one up and look at that paper.”
Abbott run-in with Indian regulators illustrates India's
shortcomings: Reuters
Authorities call out Abbott product for exceeding codeine
levels but refuse to provide sample that Abbott suspects is a fake
September 15, 2015 | By Eric Palmer
Some months ago, Indian regulators posted a
notice that a couple of batches of an Abbott ($ABT)
cough syrup was defective, that it contained twice the level of codeine is
allowed by law. But the episode, which has been going on for about 9 months, is
turning out to be less about flaws in the drugmaker's manufacturing practices
than about the flaws in India's
system of oversight.
Reuters in an exclusive story
reported that a state lab in West Bengal posted the notice last February after
Indian regulators confiscated some bottles of what they said were Abbott's
Phensedyl, a popular product that accounts for a third of the cough syrup market.
When Abbott tested its batch samples, however, it were found to be in
compliance. Months after asking India to provide one of the samples so it could
determine if it was a counterfeit, it has yet to get one. Two different
authorities each insist it must be obtained from the other.
"We are awaiting response from the
authorities," the company told Reuters in a statement.
India currently has about 1,500 inspectors to
oversee an estimated 10,000 drug manufacturing facilities. Under pressure from
the West, it has pledged to spend about $263 million in the next three years to
hire and train inspectors and to add to its laboratories. But in the meantime,
it has taken few if any steps against any its large domestic drugmakers that
the FDA has often found fault with, while companies like Abbott find themselves
defending their reputations over issues that they may not even be responsible
for.
The cough syrup products in the Abbott case
were taken near the border of Bangladesh, according to a state inspector. Reuters
reports that because products containing codeine are banned in Bangladesh, they
are often counterfeited and smuggled into that country.
Navneet Marwaha, the drug controller in the
Himachal Pradesh, acknowledged that counterfeiters often target the cough syrup
market, and that Abbott has been able to account for all of its product.
"They (Abbott) are saying 'show us the sample so we can see whether it is
genuine.' They have not been provided with the sample," Marwaha said.
Marwaha said it was up to West Bengal
authorities to provide the information to Abbott but authorities there say they
have neither the time nor the resources to follow up and that the they can't
hand over the sample without approval from Himachal Pradesh. They also said the
drugmaker would need a court order to get it. In the meantime, Abbott has left
the product in the market.
Shortcomings in India's regulatory system
became front and center several years ago when former FDA Commissioner Margaret
Hamburg during a visit to the country urged government and industry leaders to
do more to upgrade manufacturing quality and oversight. Indian regulators have
taken few, if any, steps against Indian drugmakers with which the FDA has had
repeated problems. The agency has banned products coming out of plants of Ranbaxy
Laboratories, Sun Pharma,
Wockhardt
and others after finding they had faked data to indicate that batches that
failed certain test standards were good enough to be shipped to the U.S. Indian
authorities in the past have said they looked over these facilities but never
found anything that warranted stopping production. They claimed Ranbaxy's
finished products met Indian requirements.
Under mounting pressure, including from lost
exports, the government is taking steps to do better. The Central Drug Standard
Control Organization (CDSCO) is doubling its inspector headcount to 1,000 and
has been sending trainees on plant visits with international inspectors, including
from the FDA, so that they can learn to evaluate the facilities as the Western
inspectors do.
Related Articles:
India sending inspectors on facility visits with global peers
Indian authority withdraws Ranbaxy plant export permit
Indian regulators punch up standards as FDA action takes a toll on the industry
India sending inspectors on facility visits with global peers
Indian authority withdraws Ranbaxy plant export permit
Indian regulators punch up standards as FDA action takes a toll on the industry
http://www.newsweek.com/topic/opioids
LARGEST INTERNATIOANAL GENERIC DRUG SOURCE
Pharmaceutical Industries
Pharmaceutical company · tevapharm.com
Teva Pharmaceutical Industries Ltd. is an Israeli-American multinational pharmaceutical company headquartered in Petah Tikva, Israel. Wikipedia
Founded: 1901
1. Drug distributor McKesson laying off 1,600, Bloomberg reports
Thursday, March 17, 2016 | By Eric Palmer
Drug distributor and wholesaler McKesson ($MCK) has expanded in the past couple of years, doing deals as it has followed competitor AmerisourceBergen ($ABC) in muscling up internationally. Now it will contract, whacking about 1,600 jobs.
San Francisco-based McKesson told Bloomberg in a statement that after a strategic review in January it decided that "reductions to our workforce would be necessary to align our cost structure with our business needs." The cuts amount to about 4% of its workforce, the news service said.
In January, CEO John Hammergren reported that the company expected generic price growth in the U.S. to slow in the second half of the year. Coupled with consolidation in the industry, it led the company to reduce its forecast for the fiscal year to $12.60 to $12.90 a share from a previous forecast of $12.50 to $13.
McKesson has lost some business with Target and Omnicare and also faces the loss of a major part of its business to AmerisourceBergen after the Rite Aid drugstore chain agreed in October to be acquired by Walgreens Boots Alliance ($WBA) in a $17.2 billion deal. Walgreens has a small ownership interest in and gets its drugs from AmerisourceBergen. The Federal Trade Commission is giving the Rite Aid and Walgreens deal close scrutiny.
McKesson has lost some business with Target and Omnicare and also faces the loss of a major part of its business to AmerisourceBergen after the Rite Aid drugstore chain agreed in October to be acquired by Walgreens Boots Alliance ($WBA) in a $17.2 billion deal. Walgreens has a small ownership interest in and gets its drugs from AmerisourceBergen. The Federal Trade Commission is giving the Rite Aid and Walgreens deal close scrutiny.
McKesson has made a number of acquisitions in the past few years as it battles for revenues and competes for market share globally with its rival. Earlier this month, it said it would lay out $2.23 billion (C$3 billion) to buy Rexall Health from Canada's Katz Group, picking up 470 retail pharmacies and about 8,600 employees. Last year McKesson struck a $466 million (€408 million) deal to buy drug distribution businesses in the two Irelands and the year before that bought Germany-based Celesio for about $5.4 billion
