EXAMPLES OF BIG PHARMA FRAUD
Over the last few years, many drug companies have hit the headlines for allegedly committing fraud. This document reveals several pharmaceutical companies who have been reported for committing fraud.
Pharma Fraud Number 1: Merck
Recently Merck has been in the firing line for allegedly fraudulently representing the mumps component of its MMR vaccine. It has been alleged that Merck have been fraudulently informing the public that the MMR II, used to replace the MMR vaccine Pluserix, is an effective vaccine when this is not true because the studies proving the vaccines effectiveness are said to be falsified.
According to many reports the Mumps component of the vaccination is ineffective and that the results of the tests carried out on the vaccine have been altered. The Child Health Safety website (1) reporting the story states that whistleblowers working for Merck have said that they witnessed fraud firsthand when they worked for the pharmaceutical company, between 1999 and 2002, and that they were pressured to participate.
Child Health Safety have reported that virologists Stephen A. Krahling and Joan A. Wlochowski described a supervisor working for Merck manually changing test results that showed the vaccine wasn’t working and then hurriedly destroying the evidence to keep the fraud from being exposed.
According to the report the whistleblowers stated that the supervisor then lied to FDA regulators who came to the laboratories to check after they were alerted to the problem. Child Health Safety wrote:
“A top Merck vaccine official told Krahling the matter was a “business decision,” the suit says, and he was twice told the company would make sure he went to jail if he told federal regulators the truth.”
Pharma Fraud Number 2: Medical Imports Ltd
If this was not bad enough Merck’s behavior is said to have left millions of children unprotected against mumps. Perhaps this is why there was a sudden rush to approve the single mumps vaccine MediMumps for use in private clincs. (2)
This vaccine did not have a UK license when it was advertised. This was proven in an email from a member of the public after she had raised the question with the MHRA. The email from the MHRA customer services states:
“I understand that Medi-mumps is a registered trade mark belonging to Medical Imports Ltd.
I can confirm that Medi-mumps is not the subject of a valid UK Marketing Authorisation, nor is it the subject of a Marketing Authorisation granted by the European Medicines Agency. (own emphasis)”
It has also been established through telephone conversations that the advert advertising the vaccine has been removed from The Children’s Immunization Clinics website. My informant did ask if it was possible if MediMumps was in fact Pavivac but her question were met with a stony silence.
Did Medical Imports Ltd see trouble ahead for Merck and decide to go ahead and allow an unlicensed product to be advertised to meet the demands of thousands of potential parents looking for a single mumps vaccine alternative to protect their children? Lets face it. Big pharma never misses an opportunity to cash in where they see a possible gap in the market do they?
If so, this is what could be classified as another possible act of fraud. It certainly is a breach of advertising standards if nothing else.
Incidentally, the MediMumps vaccine also contains the Jeryl Lynn strain of mumps and is probably as useless as the mumps component in the MMR II for protecting a child against mumps!
Pharma Fraud 3: GlaxoSmithKIine
Much before the China bribery scandal of 2013, involving British drug major GlaxoSmithKline, the company had come under fire earlier too. This was a scandal that would become the largest healthcare fraud settlement in US history. The drug maker paid $3 billion for promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the US FDA. (3)
The BBC said:
“The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
The settlement will cover criminal fines as well as civil settlements with the federal and state governments. The case concerns the drugs Paxil, Wellbutrin and Avandia.”
In my opinion it is about time this drugs company was brought to justice. They have been in the headlines over the drug Paxil also known as Seroxat many times. The truth about this evil drug can be found on the blog Seroxat Sufferers Stand Up and Be Counted. (4) Bob Fiddaman displays many papers identifying the tainted and rather colorful history of GSK and the drug Paxil.
It may be worth mentioning at this point that GSK also manufacturers the HPV vaccination Cervarix which has also has had problems. In a promotional video (5) that I made with SaneVax a few years ago we exposed a few Cervarix flaws that GSK had apparently forgotten to mention in their 2008 advertising campaign for doctors.
Pharma Fraud 4: Roche
In June the pharmaceutical company Roche came under fire. Fierce Pharma (6) reported that the European Medicines Agency is working with national medicines agencies to investigate deficiencies in the medicine-safety reporting system of Roche. According to the report this includes looking at whether the deficiencies have an impact on the overall benefit-risk profile for any of the products involved. Fierce Pharma state:
“The deficiencies are identified in a May 2012 report from the UK medicines regulatory agency (MHRA) following an inspection at Roche. This was part of a coordinated European program of routine inspection of safety reporting systems.
At the time of the inspection the company identified some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support program, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities. These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities!”
After 15,161 deaths you would think someone would bother to investigate the drugs involved wouldn’t you? Whether it is negligence or fraud this should have been checked and verified surely?
Pharma Fraud 5: Pfizer
Again in June we see another company come under fire. Pfizer, hit the headlines for?… you guessed it, for deceiving the public. According to Recall Lawyers (7) an email circulated by a Pfizer research director indicated that a study conducted to determine whether Celebrex an arthritis drug was safer on the stomach than other drugs–such as ibuprofen–was falsely represented. The website states:
“According to news reports, Celebrex is no better at protecting the stomach from serious complications than other drugs. Pfizer and its partner, Pharmacia, were able to misrepresent Celebrex as a safer alternative because they only released the results of half of a yearlong study. The email states, “[t]hey swallowed our story, hook, line and sinker.” Not such a great email after all, as the perpetrator has now been exposed!
Recall Lawyers wrote:
“The email, sent in 2000, is among one of thousands of internal documents recently unsealed. And while the company’s handling of Celebrex has been known for years, since 2001 when the Food and Drug Administration (FDA) released the entire study, the unsealed documents point to a widespread effort on the part of Pfizer to promote the drug in ways not necessarily backed up by medical science, and to overcome the doubts of critics. The study which formed the subject of the researcher’s email was critical to Pfizer’s Celebrex campaign–Pfizer’s main selling point of the drug was its mild effect on the stomach.”
I feel that the words ‘to promote the drug in ways not necessarily backed up by medical science’, speak volumes and that this is practice is more widely spread than any of us could ever imagine.
Pharma Fraud 6: Abbott Laboratories
In May of 2012, Abbott Laboratories pleaded guilty and agreed to pay $1.5 billion for unlawfully promoting the prescription drug Depakote for uses not approved safe and effective by the Food and Drug Administration (FDA).
According to a press release from The United States Department of Justice, (8) Abbott pleaded guilty on the 7th May 2012 to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was approved by the FDA.
The press release states:
“Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.”
I believe this to be a terrible act of fraud because it puts many vulnerable elderly patients at risk. The FDA originally approved the drug for epileptic seizures, bipolar mania and the prevention of migraines. The press release clearly states that this drug was never approved for controlling behavioral disturbances in dementia patients. This was because the drug was found to be dangerous in elderly patients causing some of them to suffer from dehydration and anorexia after using this drug. This as we all know is extremely dangerous especially in the elderly.
Pharma Fraud 7: Takeda Pharmaceuticals
Finally on my wall of shame is Takeda Pharmaceuticals. In March 2012 Ury & Moscow L.L.C. (9) stated that Takeda was in court for failing to report that their diabetes drug Actos has been found to lead to bladder cancer and congestive heart failure.
“Actos, which is manufactured by Takeda Pharmaceuticals, has been used by thousands of patients in the U.S. to help treat diabetes. However, after further studies revealed that the drug is linked to increasing one’s risk of developing bladder cancer, thousands of claims have since been filed against Takeda for failing to adequately warn consumers about the dangerous side effects of its diabetes drug.”
Later in the report it says:
“According to the lawsuit, Takeda encouraged its medical reviewers to incorrectly classify some of the reports of congestive heart failure. Although some reports of the medical condition should have been classified as serious adverse effects, Takeda asked those who initially classified some of the reports as being serious to change their opinions, the lawsuit claims. The former Takeda employee who filed the whistle-blower lawsuit claims that she attempted to protest this practice, but when she did, she was fired by the drugmaker.”
It is clear that Takeda along with all the other companies on my wall of shame will do anything for financial gain, even putting vulnerable ill and disabled patients at risk.
Pharma Fraud 8: Cetero Research
The drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain FDA drug approval. (10)
The FDA declared that both an internal company investigation and a third-party audit revealed “significant instances of misconduct and violations” in conducting clinical trials. Between April 2005 and June 2009, there were at least 1,900 instances of fraud and falsified studies, and each one of these instances was falsely used to prove that a drug was safe before it went on the market.
The FDA actually has no idea which drug companies used Cetero’s services, and it is now asking drug companies to search their records and determine whether or not they contracted with Cetero.
Even a cursory analysis of this whole approach shows how utterly foolish it actually is. Does the FDA really think the drug companies that used Cetero, are going to willingly participate in this? Of course not. It would mean the companies would have to go back and redo their clinical trials if they fess up.
These are important questions that should be asked:
– Why does the FDA itself not have records of the research companies used for the drugs that it approves?
– Why is the FDA apparently unconcerned about the safety of these drugs, considering they were approved using falsified data?
– Why is the FDA not attempting to hold Cetero accountable for its actions, other than to make an announcement about them?
Pharma Fraud 8: Bayer (Cutter Biological)
Bayer knowingly sold H.I.V. infected medications to Asia and Latin America to prevent financial losses. (11,12) After a discovered H.I.V. outbreak in America amongst small, hemophiliac children was traced back to Bayer medications, the company began to sell a new, safe medication in the West, however they sent the old batches, many of which they knew were infected, to Argentina, Indonesia, Japan, Malaysia, and Singapore. The worth of this medication totaled more than $4 million.
As unbelievable as this report may seem, I was able to trace an original article to the New York Times. Published on March 18th, 1987, it states, “Bayer A.G., the giant West German chemical company, said today that it had been sued over its sale of hemophilia drugs that may have been infected with the AIDS virus.”
It continues that Bayer representatives stated that fewer than twenty patients filed liability claims against the company, however according to a later article from New York Times, published in 2003, there’s no way of really knowing how many people were infected. Most patient records are unavailable, and since the AIDS test wasn’t developed until later in the epidemic, it’s difficult to pinpoint when foreign hemophiliacs were infected. However, in Hong Kong and Taiwan, more than 100 hemophiliacs were recorded to have contracted the disease after taking medication from the old batches.
Bayer officials, of course, stated that they had “behaved responsibly, ethically and humanely” in selling the infected medications overseas. This was after they had promised the United States regulators that they wouldn’t sell it at all. They had apparently continued to distribute the old medications for three reasons—some customers doubted the drug’s effectiveness, some countries were slow to approve sales, and due to a shortage of plasma, which is used to make the medicine, they were unable to manufacture more of the new product.
The medicine, Factor 8, was made using donated plasma from 10,000 or more donors. Since there were no screening tests for H.I.V. at the time, taking the medication was extremely risky. In the United States alone, AIDS was ultimately passed on to thousands of hemophiliacs who had taken the medication before the infected batches were discovered. Many of them have died, and the incident is now considered one of the worst drug-related medical disasters in history.
Even though Bayer admitted no wrong-doing, they’ve paid out around $600 million in settlements. The Cutter Documents—a few of which have surfaced in the media—were produced in connection with these lawsuits and outline the company’s corruption.
Pharma Fraud 9: Merck Vioxx Scandal
In 2004, pharmaceutical company Merck abruptly announced a recall of Vioxx, which was a popular pain medication at the time. After the fact, it was discovered by the FDA that Vioxx significantly increased the risk of heart attack and stroke. By the time Vioxx was pulled from the market, nearly 25 million Americans had taken the drug, and it was tied to almost 40,000 deaths. Many say that Vioxx was the worst drug disaster in history, and it is suspected that Merck and the FDA were working together to quiet the health concerns and keep the drug on the market. Fines and class action lawsuits followed, which ended up costing the company more than 5 billion dollars.
Pharma Fraud 10: Bristol-Myers Squibb Abilify Scandal
Abilify is an antipsychotic medication marketed by Bristol-Myers Squibb. In 2007, BMS had to pay over $515 million in fines because it was discovered that Abilify had been marketed for conditions that it had not actually been approved to treat. Even worse, the company had sales teams marketing the medication to nursing homes, even though they knew the drug had potentially fatal side effects for the elderly who suffer from dementia.
Pharma Fraud 11: Scientific Protein Laboratories
In 2008, the US Food and Drug Administration (FDA) announced a large-scale recall of heparin after discovering contaminated raw batches of the drug that had been manufactured in China by Scientific Protein Laboratories, a US firm. Heparin is injected into many people to prevent blood clots and is derived from slaughtered animal tissues such as pigs’ intestines and cows’ lungs. (13)
The recall followed an alleged 81 deaths and 785 other reports of severe injuries linked to the drug. Investigations identified the contaminant as an over-sulfated derivative of chondroitin sulfate, which can be used as a dietary supplement, but not as a medicine. Worst of all, several compelling reasons led authorities to believe that the contamination was deliberate, including the fact that it imitates the effect of heparin yet is a fraction of the price.
The motive for the contamination is thought to have been a combination of cost cutting and a lack of the right kinds of pigs in China. By early 2012, the FDA had added 22 Chinese heparin ingredient suppliers to an import alert list. Worryingly, the FDA also stated that it does not have enough money and that it is not up to them to inspect such overseas manufacturers on a regular basis.
Pharma Fraud 12: New England Compounding Center
In October 2012, the US Centers for Disease Control and Prevention (CDC) followed the trail of an outbreak of fungal meningitis back to the contamination of medication administered as epidural steroid injections. Packaged and sold by Massachusetts-based pharmacy the New England Compounding Center (NECC), the spoiled drugs had been sent to 75 clinics, hospitals and surgeries across 23 states. Between May and September of that year, approximately 14,000 patients received the medication.
While people reported symptoms in August, the infection was so strange that a common cause was not suspected until the following month. In fact, cases of meningitis attributed to the fungal varieties implicated were so rare that their discovery and treatment explored new medical territory.
By mid-January 2013, 678 people had contracted the fungal disease and 44 had died. Preliminary investigations found dirty, unhygienic conditions at the NECC – including steroid solutions contaminated with fungus. Authorities discovered that the NECC had distributed orders of the drug despite the fact that they were still waiting for test results that would indicate whether or not the shipment was sterile. By December 15, 2012, over 400 litigation proceedings had been launched against NECC.
How much money are we talking about anyway?
The 11 largest drug companies took $711.4 billion in profits over the 10 years ending in 2012, according to an analysis of corporate filings by Health Care for America Now (HCAN). The global pharmaceutical industry derived much of that profit from price-gouging the Medicare Part D prescription drug program for seniors and people with disabilities. Americans pay significantly more than any other country for the exact same drugs. In 2012 alone, the drug companies’ profits reached $83.9 billion, 62 percent higher than in 2003.
**Percent of $35.748 billion in overall penalties.
***Total (433) listed here is greater than the total number of settlements over the 1991 – 2015 time period (373) as 18 settlements involved more than one company.
****Other companies (in order of total penalties paid): Actavis; Sanofi; Forest; Bayer; Endo; Par; Elan; King; Watson; Shire; UCB; Genentech; KV; BASF; CareFusion; Novo Nordisk; InterMune; AkzoNobel; Biovail; Bausch+Lomb; DFB; Glenmark Generics; Hi-Tech; Pharmacal; Hoffman-La Roche; Sun; Sandoz; Jazz; Baxter; B. Braun Melsungen; Eisai; Victory; Bolar; Dava; Takeda; Cell Therapeutics; Hikma; Medicis; Astellas; Upsher-Smith; Modern Wholesale Drug Midwest; Warner Chilcott; Barr; Perrigo; Taro; The Harvard Drug Group; Otsuka; Apotex; Warner-Lambert; Mallinckrodt; Cypress; Circa; Alpharma; Dainippon Sumitomo; Ferring; Insys; Pernix; Shionogi; Wockhardt; Lupin; Gilead; Valeant; Andrx; Aventis; Chinook; Evonik; Lonza; Mitsubishi Tanabe; Mitsui; Nepera; Solvay; Sumitomo; Vertellus.
While it may seem like a large sum, the approx. $35.7 billion paid by the pharmaceutical industry from 1991 through 2015 represents a miniscule fraction of drug company profits – just 5% of the $711 billion in net profits made by the 11 largest global drug companies during only 10 of those 25 years (2003-2012).(14)
It’s pretty sad that fines for Big Pharmaceutical companies breaking the law are just looked upon as the cost of doing business. Since these corporations are continuing to break the law, how are they not criminal enterprises? The FBI defines a criminal enterprise as “a group of individuals with an identified hierarchy, or comparable structure, engaged in significant criminal activity.”
Corporations should likewise be eligible to be labelled as criminal enterprises, as they are groups of individuals with an identified hierarchy that can engage in significant criminal activity. Corporate directors and officials should thus be found guilty for the corporation’s bad acts, instead of just paying fines and going back to business as usual.
1. Child Health Safety Merck Vaccine Fraud – 2nd US Court Case Over MMR Vaccine http://childhealthsafety.wordpress.com/2012/07/02/merck-vaccine-fraud-2nd-us-court-case-over-mmr-vaccine/
2. VacTruth New Vaccine Made From Dog Cells May Trigger Allergies To Dogs http://vactruth.com/2012/05/25/vaccine-dog-cells-allergy/
3. BBC News GlaxoSmithKline to pay $3bn in USdrug fraud scandal http://www.bbc.co.uk/news/world-us-canada-18673220
4. Sexoxat Sufferers Stand Up And Be Counted http://fiddaman.blogspot.co.uk/
5. YouTube Cervarix Vaccine GSK’s Promotional Flaws http://www.youtube.com/watch?v=iD2i7YYAID4&feature=related
6. Fierce Pharma European Medicines Agency acts on deficiencies in Roche medicines-safety reporting http://www.fiercepharma.com/press-releases/european-medicines-agency-acts-deficiencies-roche-medicines-safety-reportin
7. Recall Laywers Securities Fraud Case against Pfizer shows Deception of Celebrex Safety http://www.the-recall-lawyers.com/2012/06/securities-fraud-case-against.html
8. Press Release United States Department of Justice Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote http://www.justice.gov/opa/pr/2012/May/12-civ-585.html
9. Ury & Moscow L.L.C Attorneys and Councilors of Law EX-EMPLOYEE SAYS TAKEDA FAILED TO REPORT ADVERSE EFFECTS OF ACTOS http://www.connecticutdangerousdrugsandinjurieslawyers.com/2012/03/ex-employee-says-takeda-failed-to-report-adverse-effects-of-actos.shtml
10. Reuters, FDA finds U.S. drug research firm faked documents http://www.reuters.com/article/us-fda-cetero-violation-idUSTRE76P7E320110726
11. A.P. New York Times. Mar 18, 1987. (http://www.nytimes.com/1987/03/18/business/bayer-named-in-aids-suit.html)
12. Bogdanich, Walt and Koli, Eric. The New York Times. May 22, 2003. (http://www.nytimes.com/2003/05/22/business/2-paths-of-bayer-drug-in-80-s-riskier-one-steered-overseas.html?src=pm&pagewanted=1)
13. New York Times. APRIL 30, 2008. Heparin Contamination May Have Been Deliberate, F.D.A. Says. http://www.nytimes.com/2008/04/30/health/policy/30heparin.html
14. Public Citizen, Pharmaceutical Industry Settlements: 1991 Through 2015 http://www.citizen.org/documents/PublicCitizen-PharmaSettlements1991-2015-ChartBook.pdf