(SimonQ, CC BY-NC-ND 2.0) Acetaminophen kills hundreds of Americans every year, sending thousands to the emergency room with at least 2,600 hospital admissions.
Presently, the drug manufacturer is defending itself in federal court from at least 85 different lawsuits from consumers claiming harm and from surviving family members claiming wrongful death, with heartrending anecdotes about the deceased. During the past decade, hundreds of Americans have died after unintentional overdoses of the country’s most popular pain reliever.
Nearly 500 Americans die yearly from acetaminophen overdoses, with 2,600 hospitalizations and some 56,000 emergency room visits, according to a 2004 study from the University of Texas. The drug is also implicated in nearly half of all cases of liver damage, researchers say. At the same time,the Tylenol brand makes more than $1 billion in revenue every year, aside from competitors.
Although the U.S. Food and Drug Administration (FDA) refers to acetaminophen overdose as a “persistent, important public health problem,” regulatory oversight of the drug — safe for adults, children, and infants in the right doses — has been criticized by some as too lax, compared to other developed countries from Europe to Asia. U.S. regulators ruled in 2009 to require a label warning of “severe liver damage” after convening an expert panel in 1977 — 32 years later.
I have posted on how Ranbaxy and Johnson and Johnson sell at a higher price/spurious products and how Johnson and Johnson is relaunching the same product that was whose licence was canceled for using a Carcinogen in the formula.
Some Retailers allow a discount of 20% on MRP, while periodically going on strike for increased margins.
On checking up with a Retailer well known to% discount , in some products, they make at least 30 % Margin!
Imagine the profit the Drug Companies are making!
The net profit of the Drug Companies are making is very high after paying out millions of Dollars paid out to doctors for prescribing their products!
Nine drug makers, including Ranbaxy, Dr Reddy’s Labs, Glenmark, Cipla and Cadila Health, are likely to face a hefty penalty from the National Pharmaceutical Pricing Authority (NPPA) over allegedly selling anti-asthma drugDoxofylline without prior price approval. The move comes in the wake of a recent Supreme Court order against the industry that brought the widely prescribed medicine under price control.
The total penalty on the nine firms is estimated to be Rs 2,500 crore because the fine will be calculated in retrospect from 2009, when the price of the drug was fixed by NPPA.
According to official sources, NPPA has already sent notices to four drug companies — Ranbaxy, Cipla, Cadila and Glenmark — for allegedly overcharging on sale of their individual brands containing Doxofylline.
The instances of Multinationals stealing indigenous medicines is well-known.
So are the capricious overpricing of life saving Drugs, like Cancer Drugs.
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The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.
Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.
Western pharmaceutical companies have been pushing for stronger patent protections in India to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’
Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.
India drew first blood in a Patent case in The Supreme Court .
Supreme Court , India,Judgement, Novartis Case
‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…
Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.
Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)
Cost of its generic versions : 8,000 -10 ,000 per month
No. of cancer centres in India: 450 approx (half are in the private sector)
The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.
Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.
The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.
“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.
In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.
Pharmaceutical Companies are involved in Crimes themselves, like Testing of new Drugs on unsuspecting people especially in poor countries, including India.
Interpol
I have posted on this.
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Drugs ,it is reported that , are not tested on children and are marketed.
The FDA is of the opinion that Clinical Trials of Drugs conducted on Children give off reliable results,especially the contra-indications.
I am reproducing a real instance quoted in The Scientist.
Or let’s take the Case of Union Carbide , which caused the death of people in Bhopal Gas Leak Tragedy in India and the CEO was let off and he was not extradited.
They are yet to pay equitable compensation to the maimed.
Or take the case of arbitrary price-fixing and stealing Locally Patented Medicines.
The Corporate Companies are transnational.
If they are involved in Crime like these how do you arrest them?
Do you believe that Interpol would chase them, now that they are funding Interpol?
Tomorrow Columbian Drug Cartel may contribute to Interpol for fighting Drug abuse?
Story:
LYON, France – Combating the global scourge of fake medicines which threatens the health of millions of people is the focus of a landmark agreement between INTERPOL and 29 of the world’s largest pharmaceutical companies.
The three-year deal, worth EUR 4.5 million, will see the creation of INTERPOL’s Pharmaceutical Crime Programme to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit. This will enhance the law enforcement community’s response to pharmaceutical crime through stronger partnership development.
The programme will focus on the prevention of all types of pharmaceutical crime including branded and generic drug counterfeiting as well as the identification and dismantling of organized crime networks linked to this illegal activity, which generates millions in illicit profits every year.
“With no country, no drug, no medical product immune from counterfeiting, a global effort is needed to combat this threat which puts the lives of millions of people at risk every single day,” said INTERPOL Secretary General Ronald K. Noble…
‘Counterfeit is essentially an intellectual property issue referring to falsely packaged products that violate trademarks, but it is not necessarily about the quality of the medicine. We use the word spurious to refer to drugs without active ingredients in it. Big pharma has been trying to confuse the two issues and have been trying to make counterfeit seem like a public health issue when it is not,” explained K Gopakumar legal advisor to Third World Network.
“Last month, there was a meeting in Vienna of the United Nations Office on Drugs and Crime on “fraudulent medicines” which was pushed by multinational companies. Before that, there was the issue of the International Medical Product Anti-Counterfeit Task-force (IMPACT) when it came to the WHO and that was also an initiative launched by the multinationals. ThisInterpol effort seems to be along the same lines. We are very concerned about this move by multinationals to fund Interpol and we will surely be looking into it,” said Rajeev Kher, additional secretary in the department of commerce and India’s chief negotiator at the WTO. According to Kher, since CBI was a Interpol member, its officials and the home ministry participate in all activities of the Interpol it was a matter of concern.
In order for scientific studies to happen, someone has to pay for them.
The top funder for any drug trial is the pharmaceutical company that makes it, since the manufacturer is most invested in “proving” how spectacular its drug is. Dr. Golomb uses the case of statins as an example, stating that all of the major statin studies have been funded exclusively by the drug industry.
The second-highest funder of drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be. In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry.
But drug companies publish only a fraction of the studies they fund — the ones that promotetheir drugs.
In contrast, studies that have favorable findings almost always make the cut.
There are simply thousands of scientific studies out there that have never been seen by you or your physician because they have been screened out by editors and reviewers who are being paid to uphold an industry agenda.
Published studies overwhelmingly favor the funding company’s drug. Whichever drug is manufactured by the study sponsor is the drug that comes out on top, 90 percent of the time!
Given this, how can medical journals be considered unbiased?
Bias #2: Bad Results are Submitted as Good
When a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones.
For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA’s findings were then written up in an article in the New England Journal of Medicine1.
This is what they found:
38 of the trials reported positive results, and 37 of the 38 were published.
36 trials had negative or questionable findings. Of the 36, 22 were not published at all, and 11 were published in a way that conveyed the results as though they were positive.
So, if you just went to the published literature, it would look like 94 percent of the studies were positive, when in reality only about 50 percent were positive … equivalent to a coin toss.
For statins, the odds that the funding company’s drug will come out on top are staggering1:
The odds that the funding company’s statin drug will come out looking better than anyone else’s statin in the “results” section of the article are 20:1.
The odds that the funding company’s statin will come out on top in the “conclusions” part of the article are 35:1.
So, even if they can’t make the results look good, they can often find a way to twist the conclusions so that their drug appears favorable.
Selectively omitting negative trial results can be devastating to your health, as Merck & Co. proved when they concealed the fact that three patients suffered heart attacks from Vioxx during clinical trials. They conveniently omitted this data (along with other relevant findings) from the copy of the study they submitted to the New England Journal of Medicine for publication.
The omissions were uncovered years later during the 7,000 Vioxx lawsuit litigations.
Bias #3: A Favorable Study is Submitted Multiple Times
When a study yields positive results, it is often submitted multiple times in a way that the reader doesn’t realize it’s the same study, obscured by different author lists and different details. Analyzers have had to look very carefully to determine which studies are actually duplicates because they are so cleverly disguised.
Not surprisingly, trials reporting greater treatment efficacy were significantly more likely to be duplicated, according to Dr. Golomb’s reporting.
In one analysis of the published reports about ondansetron (an anti-nausea drug), the same study was published 5 times. This duplication of data led to a 23 percent overestimation of ondansetron’s effectiveness when a meta-analysis was performed.2
Talk about good mileage!
Bias #4: Follow-Up Reviews Done by Biased Experts
The editorials that follow from a study, submitted by so-called unbiased experts and then published in reputable journals, are often done by non-neutral parties who have a financial tie to the drug maker.
Dr. Golomb uses the case of calcium channel blockers (a type of heart medication) as an example. The connection between authors declaring their support for calcium channel blockers and those not in support of them was highly statistically tied to their affiliation with the drug manufacturer — in fact, the odds that their opinion was NOT due to their affiliation was more than 1,000:1.
Bias #5: Ghostwriting
Many of the articles that appear in medical journals purportedly written by well-known academics are actually written by unacknowledged ghostwriters on Big Pharma payroll.
Consider the example of Parke-Davis and their drug Neurontin.
Parke-Davis contracted with a “medical education communication company,” or MECC, which is a company paid almost exclusively by pharmaceutical companies to write articles, reviews, and letters to editors of medical journals to cast their products in a favorable light.
In this case, MECC was paid $13,000 to $18,000 per article. In turn, MECC paid $1,000 each to friendly physicians and pharmacists to sign off as authors of the articles, making the materialappear independent.
This was also done by Pfizer as a strategy for marketing Zoloft. A document was written that included 81 different articles promoting Zoloft’s usefulness for everything from panic disorder to pedophilia.
The only problem was, for some articles, the name of the author was listed as “to be determined,” even though the article was listed as already completed. They weren’t helping out an existing team of scientists who happened to be talentless at writing — Pfizer wrote the article, and then shopped around for scientists willing to claim authorship, to give it a veneer of credibility.
Medical journals are generally considered by medical practitioners to be a source of reliable information. But medical journals are also businesses.
Three editors, who agreed to discuss finances only if they remained anonymous, said a few journals that previously measured annual profits in the tens of thousands of dollars now make millions annually.
The truth is that Big Pharma has become quite adept at manipulating and brainwashing practitioners of conventional medicine. They influence the very heart and center of the most respected medical journals, creating dogma and beliefs that support the drug paradigm because it is blessed by the pinnacle of scientific integrity: the prestigious peer-reviewed medical journal.
Peer-reviewed medical journals contain advertisements that are almost exclusively for drugs, amidst articles that are biased toward promoting those drugs. If you have looked through a medical journal lately, you’ll see full-page Pharma glossies, cover to cover.
In 2003, drug companies spent $448 million dollars on advertising in medical journals2. It has been calculated that the return on investment on medical journal ads is between $2.22 and $6.86 for every dollar spent, with larger and older brands at the higher end.
Long-term returns may be even higher when you consider that one ad viewed by a physician could result in hundreds or even thousands of drug purchases, based on the prescriptions he or she writes.
The term “peer-review” has come to imply scientific credibility. But the fact is that many of the peer-reviewers are on the drug company’s payroll, and those who are not are unlikely to detect flawed research or outright fraud.
Medical journals are the number one source of medical information for physicians. In fact, nearly 80 percent of physicians use medical journals for their education, which exceeds information from any other source3.
Do you really want to blindly take the advise of a physician whose only source of medical information is a medical journal engaged in such profound conflicts of interest?
Advertisements for drugs focus the “latest and greatest” drugs to hit the market, drugs which may not be superior to existing, less expensive alternatives. So physicians are seduced into prescribing the newest, most expensive drugs, which drives up your healthcare costs.
An excellent article in PLoS Medicine regarding drug advertising in medical journals concludes4:
“The scholarly nature of journals confers credibility on both articles and advertisements within their pages. By exclusively featuring advertisements for drugs and devices, medical journals implicitly endorse corporate promotion of the most profitable products. Advertisements and other financial arrangements with pharmaceutical companies compromise the objectivity of journals.
The primary obligation of industry is to make money for its stockholders. The primary obligation of journals should be to physicians and their patients, who depend on the accuracy of information within these publications. Medical journals should not accept advertisements from pharmaceutical companies, medical device companies, or other industries ‘relevant to medicine.’”
In 2004, Dr. Richard Horton, editor of the Lancet, wrote, “Journals have devolved into information-laundering operations for the pharmaceutical industry.”5
Bias #7: Drug Companies Masquerading as Educators
The education of medical students and residents also comes through the filter of the drug industry, which seeks to groom them before they even finish medical school.
According to Dr. Golomb’s data, Big Pharma now spends $18.5 billion per year promoting their drugs to physicians. That amounts to $30,000 per year for every physician in the U. S.!
And drug companies are allowed to develop their own education curriculum for medical students and residents, lavishing them with gifts, indirectly paying them to attend meetings and events where they promote the company’s products.
Why is the Accrediting Commission for Continuing Medical Education (ACCME) so permissive with industry involvement?
Almost half of the members are representatives of Big Pharma or are consultants for businesses that work directly with it to prepare these educational programs. Only a few represent academic CME institutions.
Any discussion of physician “seduction” would be incomplete without the mentioning of the 100,000 drug reps, who are groomed and trained to wine and dine and otherwise shower physicians in sweetness until they are handing out prescriptions like candy.
Reps are even taught tactics for manipulating doctors for industry benefit, as a standard part of their training.6
Hell Hath No Fury
What happens if a physician or other person speaks up about these conflicts of interest? What happens to the proverbial whistle-blower?
Intimidating phone calls and direct threats, for starters.
In one case, Dr. Buse, an endocrinologist who is the incoming president of the American Diabetes Association, presented data in 1999 about his concerns about the risks of Avandia. Dr. Buse was intimidated with multiple phone calls by drug company officials. They suggested he could be financially liable to the company for $4 billion in lost revenues due to his “unscrupulous remarks.”
Other truth-tellers have had their reputations trashed or job offers rescinded for speaking the truths that Big Pharma works so hard to keep under wraps.
“Too Big to Nail”
An individual truth-teller might be vulnerable to the wrath of an angry drug company, but drug companies are unlikely to suffer much of a consequence for their crimes.
Pfizer, the world’s largest pharmaceutical company, engaged in illegally promoting their drug Bextra for off-label use, despite their knowledge that it was associated with an increased risk of stroke and heart attack.
Bextra was pulled from the market in 2005, but not before many people were damaged by its use. When Federal prosecutors realized that convicting Pfizer would likely be a corporate death sentence (as any company convicted of major health care fraud is excluded from Medicare and Medicaid), they cut Pfizer a deal. Just as the big banks on Wall Street were deemed “too big to fail,” Pfizer was deemed “too big to nail.”
Why?
Prosecutors claimed to be concerned about the loss of jobs by Pfizer employees and financial losses to Pfizer shareholders as a result of being excluded from the Medicaid/Medicare programs.
So the prosecutors charged a Pfizer subsidiary, Pharmacia & Upjohn Co., instead. In fact, this particular subsidiary company was created specifically for this purpose, as a sacrificial lamb, having been incorporated the very same day its lawyers filed a “guilty” plea in another case involving kick-backs, leaving Pfizer with the penalty equivalent of being sent to bed without supper.
In the end, all Pfizer lost was about three month’s profit, but all contracts, including those with Medicaid and Medicare, were spared.
This is just one more example of your federal government failing to protect you, and opting to protect big business’ interests instead.
The bottom line is, the drug companies aren’t going to protect you.
And it is unlikely that your physician can protect you either — even a well-meaning one — when he or she is operating within a system that has become RIGGED for Big Pharma profit.
Only you can protect yourself.
So, until real systemic change takes place, your best health strategy is quite simply to employ and maintain a naturally healthy lifestyle that will optimize your body’s innate healing abilities and minimize your need for the drug companies’ latest concoctions.
Five out of six approved prescription drugs seldom benefit patients, says a critic of the pharmacy industry. The 6th one works just because big pharma says it does.
Chloresterol-lowering statins were a conspicuous example of the drugs industry over-hyping a product to avert heart attacks, even though they could do more harm than good, said Donald Light, sociologist and professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, U.S.
Drug corporates hyped-up patented medicines, spent astronomical sums on getting doctors to prescribe them and underplayed serious side-effects, reports the Telegraph.
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