Monday 20 October 2014

Drug manufacturers covered up their tainted drugs                          

There is very little that one could say is more despicable than those drug manufacturers who sell tainted pharmaceutical drugs to pharmacies who then sell them to unsuspecting customers. 

The Toronto Star, Canada’s largest newspaper, conducted an investigation on forty Canadian pharmaceutical manufacturers. What they discovered will shock you. According to their investigation, these companies had hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe and they didn’t report evidence of side-effects suffered by consumers taking their drugs. Further, since 2008, these forty Canadian drug companies, including Toronto-based generic giant Apotex have been cited for serious manufacturing violations.

If you think selling tainted food to unsuspecting customers is bad, consider what will happen to those unsuspecting customers who get tainted drugs. Whereas the first group of customers can get real sick, the second group of customers can get real dead.

As China revamps its healthcare system to make it more affordable to its 1.3 billion population, bureaucrats have gone all out to lower drug prices in large drug tenders that give winners a captive market spanning several provinces in China.

Later it was discovered that 77 million capsules were made of industrial gel containing chromium, a carcinogenic (cancer causing) heavy metal, which was the latest in a series of safety problems blighting China's healthcare industry, including the widespread manufacture of fake drugs. China announced in May that 254 pharmaceutical suppliers, or 12.7 percent of the total, were producing tainted capsules. At least 10 were listed or linked to China-listed firms, according to the official Chinese media. Of 11,561 batches of drugs tested, 5.8 percent contained excessive levels of chromium.

The problem was and still is pervasive because of the pressure on drug manufacturers to produce low-cost drugs and still make a profit, and the popularity of traditional Chinese medicine, which is often made into powders and packed into capsules. Of course, those that ingest the so-called medicine have no idea that they are swallowing death.

The Chinese government has repeatedly promised to tighten regulatory systems after safety scandals involving fish, toys, toothpaste, children's clothes, tires, drugs and milk fortified with melamine which is used in the manufacture of tabletops and drugs. But little has been done apart from a few, highly publicized arrests. Some of the authorities curtailed the arrests because of graft.

The unreasonably low winning prices directly challenged the safely bottom lines of the essential drugs, put Chinese people's health in severe jeopardy and affect normal production and supply of these essential drugs since some of the drug manufacturers  chose to include hazardous chemicals in the capsules rather than included more of the more expensive pharmaceutical drugs.

Pharmaceutical maker, Ranbaxy which is located in India, had t0 pay $500 million to North Carolina, other states and the federal government of the United States for selling generic drugs that didn’t meet quality standards.

Ranbaxy sold drugs that fell below the quality, purity and/or strength standards required by the US Food and Drug Administration (FDA). The U.S. FDA inspects facilities in Canada and around the world where drug and drug ingredients bound for the U.S. market are made. The regulator may ban drugs from the U.S. market or prevent a company from introducing new products until the manufacturing and safety problems are fixed.

At issue were 26 generic drugs manufactured at company facilities in Paonta Sahib and Dewas, India between April 1, 2003 and September 16, 2010.  As a result of the sub-par drugs, false or fraudulent claims were submitted to the US government-funded health care programs, including North Carolina’s Medicaid program.

A drug manufacturer called Ranbaxy paid the various US states and the US federal government $350 million dollars to resolve civil allegations of poor manufacturing practices in two Indian manufacturing plants. Additionally, subsidiary Ranbaxy USA had pleaded guilty to seven felony violations of the U.S. Food, Drug, and Cosmetic Act and had to pay $150 million dollars in criminal fines and forfeitures—the total being $500 million which would far exceed what profit those companies got by selling their bad drugs.

The Medicaid Investigations Division (MID) investigates fraud and abuse by hospitals, doctors, pharmaceutical companies, medical equipment companies, mental health and personal care providers, ambulance services and others, as well as patient abuse and neglect in Medicaid-funded facilities. Over the past decade, MID has recouped more than $500 million in damages and helped to convict hundreds of individuals on criminal charges.

Now I will return you to the report of the Toronto StarWhile the Federal Drug Administration (FDA) strictly and transparently enforces drug manufacturing laws, Health Canada leaves Canadians in the dark by keeping secret details of problems its inspectors gave found. This is a colossal mistake on the part of Health Canada because unless patients who have taken bad drugs that were discovered by the FDA are informed as to what they are, the patients taking them may continue taking those bad drugs that are either entirely useless or alternatively are harmful to their health.

Worse yet, drugs and drug ingredients banned from the U.S. market have been allowed by Health Canada into Canadian pharmacies. One is forced to ask this rhetorical one-word question—why?

The inspection documents obtained by the Toronto Star revealed:  In June, 2014 at a facility in Bangalore, India, that makes drugs destined for North America; Apotex employees did not report undesirable test results and doctored bacterial growth test records. Generic drug maker Taro Pharmaceuticals in Brampton, Ontario kept drugs on the market despite company tests showing batches of the medications deteriorated before the expiry date listed on the label and Cangene Corp., a Winnipeg drug manufacturer, failed to tell authorities of blood clots, fever and other side-effects associated with their products.

A can think of three words that best describes these failures in the care undertaken by these pharmaceutical companies—sloppiness, indifference and greed.

here have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in findings termed “objectionable” or noted as “repeated deficiencies.” In one case, the FDA said the company failed to uphold its legal obligation to prepare dugs in the proper manner.

During an interview at one of Apotex’s Toronto factories, and in email correspondence, company president and CEO Dr. Jeremy Desai and another manager did not challenge the FDA’s findings and told the Toronto Star that their firm was fixing the problems and its products are now safe. Desai told the Star “compliance is a journey” and his company has addressed what he calls the “procedural lapses” identified by the FDA and has invested in improved data collection and staff training programs.

Let’s back up a little. Why didn’t Apotex discover the problem, earlier?  How long was their journey before the US FDA found the problem? Was the quality of the standards of Apotex so low, that their own staff couldn’t find out what their problems were?  This is frightening when you think about it. A firm that can’t discover their own failures in their manufacture of pharmaceutical drugs until the FDA discovers their failures; puts the people who ingest those drugs in harm’s way.

 Health Canada spokesman Gary Holub emailed the Star saying, “Health Canada does not allow drug products to be sold, including those imported for sale, in Canada unless there is satisfactory evidence that good manufacturing practices standards are being met in the facility where the product is made.” He also said the Canadian regulator also monitors drugs on the market to identify and act on safety risks to patients should they emerge.  Well, was the Canadian regulator asleep at the switch while bad drugs were being sent to Canada’s drugs stores? That too is frightening.

Since 2008, the FDA has conducted at least 110 inspections of Canadian facilities or foreign factories owned by Canadian firms that have resulted in objectionable findings. What I don’t understand is; why doesn’t Health Canada conduct inspections of Canadian facilities and check up on the quality control of the manufactures of these drugs wherever they may be manufactured in Canada or in other countries?

However, some of the dummies in Health Canada finally awoke long enough to place a ban on all drugs and drug ingredients made by two Apotex factories in Bangalore, India. And it doesn’t surprise me one bit that Health Canada hasn’t recalled any drugs made by those two factories  currently in the drug stores. Further, the regulator is now paying attention to the results of FDA reports. However, he didn’t name the drugs that were under review so the drug stores and their customers are still in the dark about whether or not the drugs made by those two companies are safe.  

Health Canada is a farce. The people running it are secretive and incompetent. The management in that government body should be removed as soon as possible and replaced with more suitable people who understand the concept of responsibility. Letting those useless managers to continue remaining in Health Canada is about as dumb as letting cockroaches remain in your kitchen because they have always been in your kitchen. 

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