MHRA Policy for Handling Conflicts of Interest
MHRA Conflicts of Interest Flowchart
MHRA Conflicts of Interest Statement
MHRA/NIBSC Merger Information
Upon its merger with the National Institute of Biological Standards and Control (NIBSC), the UK Medicines Healthcare Products Regulatory Agency (MHRA) has developed and released its new conflicts of interest (COI) policy in an attempt to improve transparency and recognize potential sources of conflicts.
MHRA Policy for Handling Conflicts of Interest
MHRA Conflicts of Interest Flowchart
MHRA Conflicts of Interest Statement
MHRA/NIBSC Merger Information
Pharmacare 2013 was a success!
Pharmacare 2013, held in Ottawa, Canada, attracted a wide range of Canadian experts, senior government managers, health policy analysts, health practitioners and professionals, academics, policy makers, unions, elected government officials, students, and the public. Pharmaceutical and health care policy experts from New Zealand, United Kingdom, and France were also in attendance. Generic and brand-name drug industry representatives were also in attendance and contributed to the dialogue.
All of these representatives came together to build political momentum and discuss and debate strategies for implementing a national pharmacare program to afford all Canadians with equitable access to essential prescription medications, to be identified and listed on a national drug formulary. Implementing a national pharmacare strategy would control costs of prescription medications by allowing a unified provider to negotiate drug costs with the respective drug companies and reduce the costs associated with having an administrative system fragmented by individual provinces bearing the burden of individually negotiating confidential pricing contracts for drugs with each company. A national pharmacare program would also improve not only drug safety and monitoring, but also physicians' prescribing practices.
Currently, all developed countries globally that have universal health care systems, as does Canada, provides universal coverage for prescription drugs - except Canada. Canada can afford a such a program. Pharmacare would allow Canadians, who already pay out-of-pocket or through private insurance for prescription drugs, to pay more effectively, economically, and fairly.
View the Pharmacare 2013 website here: http://pharmacare2013.ca/
View the Pharmacare 2013 agenda here: http://pharmacare2013.ca/agenda/
View the Pharmacare 2013 speakers here: http://pharmacare2013.ca/speaker-biographies/
Recent claims have been made that Novartis downplayed the risks of its bisphosphonate, Zometa (zoledronic acid). Like Fosamax, which is also the subject of current litigation in Canada and the United States, Zometa is prescribed to treat and prevent osteoporosis. Zometa is primarily prescribed and administered intravenously to patients with cancer and has been associated with the same side effects as Fosamax. These side effects include bone pain, atypical fractures, and osteonecrosis of the jaw. Zometa has been prescribed to treat over 4 million patients in the United States and is approved for use in 95 countries globally.
The first Zometa personal injury case to was took place in 2009 and was initiated by Peggy Stevens, 57, of Missoula, Montana. Stevens had lymphoma and developed osteonecrosis of the jaw. The case was brought to trial on the bases of failure to properly warn and Stevens was awarded $3.2 million in compensatory damages. Her lawyers were able to provide evidence that Novartis had known about Zometa's risks, had communicative exchanges via email about these risks, and continued to suppressed the risks.
Most recently, in February 2013, Novartis Pharmaceuticals was found liable by a New York jury for $450,000 in damages and $10 million in punitive damages, totaling $10.45 million awarded to Barbara Davids. Davids was diagnosed with stage I breast cancer and was prescribed Fosamax to treat osteoporosis and Zometa to prevent or reduce the risk of bone fracture or damage from cancer that may have metastasized to the bone. Davids also developed osteonecrosis of the jaw after taking Zometa. In this case, a central claim was that the FDA had approved Zometa on the condition that Novartis provides the FDA with stronger safety information on the drug's association with osteonecrosis of the jaw and that Novartis had falsely labelled the severity of Zometa's risk factors. Davids sought compensatory damages under negligent failure to warn, among other theories. Davids also filed a lawsuit against Merck, the manufacturer of Fosamax.
Case: Stevens, Plaintiff v. Novartis Pharmaceuticals Corporation, Defendant and Appellant
Missoula Woman Awarded $3.2M in Lawsuit Against Maker of Bone-Strengthening Drug Zometa
Case: Davids, Plaintiff v. Novartis Pharmaceutical Corporation, Defendant
Jury Awards $10.45 Million in Zometa Lawsuit Over Woman's Jawbone Damage
Lawsuits continue to be filed against Johnson & Johnson for misleading marketing of its antipsychotic drug, Risperdal (risperidone). Johnson & Johnson is accused of illegally promoting Risperdal by minimizing the data on risks for side effects including diabetes and weight gain, and suppressing evidence of hormone alteration in children that resulted in the abnormal development of large mammary glands in males. Thus far, in the United States, Johnson & Johnson has agreed to pay approximately $2 billion in settlements for their deceptive marketing of Risperdal. A Kentucky case claimed that Johnson & Johnson willfully engaged in misleading marketing by
"(a) Making unfair, false, misleading, or deceptive representations of fact regarding Risperdal's safety profile in Risperdal's labeling ... misrepresenting the likelihood and severity of the side effects associated with Risperdal, such as diabetes, hyperglycemia, weight fain, hyperprolactinemia ...
(b) concealing material facts by ... not disclosing any warning about Risperdal-induced weight gain [and] Risperdal-induced diabetes/hyperglycemia/other metabolic dangers, not disclosing until mid-2003 any warning about the risk of Risperdal causing cerebrovascular adverse events including stroke in the elderly with dementia, and not disclosing until mid-2007 any warning that Risperdal has the potential to cause hyperprolactinemia or that Risperdal is associated with higher levels of prolactin elevation and, thus, a higher risk of hyperprolactinemia than other antipsychotics ...
(c) Making unfair, false, misleading, or deceptive representations of fact regarding Risperdal's safety profile in Risperdal sales aids and related promotional materials and messages, including but not limited to misrepresenting the likelihood and severity of the side effects associated with Risperdal, such as diabetes, hyperglycemia, weight gain, hyperprolactinemia, cerebrovascular adverse events including stroke in elderly patients with dementia, and other serious and potentially life-threatening conditions;
(d) Concealing material facts [and] not disclosing the negative results of Trial 113 or the ERI study and other negative safety information about Risperdal in Resperdal sales aids and related promotional materials and messages; and
(e) Making unfair, false, misleading, or deceptive representations of facts regarding Risperdal's assocaition with diabetes and other metabolic disorders in the November 2003 "Dear Doctor" letter."
Commonwealth of Kentucky ex rel. Jack Conway, Attorney General v. Janssen Pharmaceuticals, Inc. and Johnson & Johnson, Inc.
The Risperdal Lawsuits Keep on Coming: Kentucky Sues J&J
A Federal Court judge in Australia refused to settle a case in which Australians claimed to be experiencing heart problems, such as heart attacks and strokes, while on Vioxx, an arthritis medication. The settlement would have provided maximum $2,000 for each of the 1700 plaintiffs in the class action suit against Merck's Australian subsidiary. The Australian judge, Justice Christopher Jessup, refused to the settlement because he believed that the settlement would have been unfair for plaintiffs who had a stronger case against the Merck regarding Vioxx.
Australian Judge Kills Merck Vioxx Class Action Settlement
Judge Refuses to Approve Vioxx Settlement
See a Canadian class action plaintiff request to approve a Settlement Agreement with Merck for Vioxx
Pharmaceutical companies track physicians' prescriptions, patients' refilling patterns, and health details for marketing purposes
Pharmaceutical companies have developed vast databases that document and track information on not only patients’ prescription refilling patterns and treatment compliance, but also details of their medical conditions, lab test results, and demographics. Additionally, these databases track physicians and their prescribing practices and patterns, which can then be compared with those of their colleagues.
The sponsoring drug companies maintain that these databases are useful for doctors to improve prescribing practices and ensure that patients are being prescribed the correct medications, but some physicians have expressed concerns regarding the sensitivity of the data, which is being used by companies to market medications, as well as the fact that physicians are typically unaware “...of the depths to which they are being analyzed and studied by people trying to sell them drugs and other medical products.”
A Harvard Medical School professor, Dr. Jerry Avorn, stated that “...a lot of this stuff happens under the radar – there may be a sales pitch, but the doctor may not know that the sales pitch is being informed by their own prescribing practice.” A law professor at Indiana University argues that the ways in which pharmaceutical companies use data originates within the doctor-patient encounter and has become more invasive.
Pills Tracked from Doctor to Patient to Aid Drug Marketing
Janssen Korea, of Johnson & Johnson, was ordered to stop its manufacturing of two types of Children's Tylenol Syrup because the South Korean manufacturer violated regulations.
Janssen Korea's CEO, Oak-Yeon Kim faces potential criminal charges and three years in jail under the Korean Pharmaceutical Affairs Act because the manufacturer continued selling the two types of Children's Tylenol syrup that contained amounts of acetaminophen (active ingredient in Tylenol) in excess of that which was described on the label. The applicable sections of the Korean Pharmaceutical Affairs Act include: Articles 56, 58, 62, 69, 93, 94.
Although the Korean Times maintains that no adverse reactions have been reported, excessive amounts of acetaminophen were potentially contained in 38,000 bottles sold of the Children's Tylenol syrups, which could lead to liver damage.
CEO of J&J OTC Unit in Korea Faces Criminal Action over Plant Foul-Up
J&J Halts Tylenol Production In South Korea Over Mishap
Millions of J&J OTC medications recalled and an FDA consent decree
Janssen Korea CEO Faces Legal Action
Drug companies using social media networking diagrams to locate and track professional behaviours of influential physicians
Consulting firms, hired by pharmaceutical companies, are now using social media networking programs and diagrams to locate influential doctors so that they may be used as aids to companies' marketing incentives. These pinpointed physicians are used by drug companies' marketing teams and drug reps to be the subjects of targeted marketing with the intention that these physicians will be able to influence their peers' and colleagues' prescribing decisions in favour of a company's drug.
Take a look at an example of a social networking diagram used by a pharmaceutical company to track physicians' prescribing of oncology medications here.
Drug Marketers Use Social Network Diagrams to Help Locate Influential Doctors
Mined Doctor-Patient Data Gives Drugmakers Insight for Targeted Marketing
As a result of FDA inspections of drug compounding facilities in the first quarter of 2013, a total of 107 drugs were recalled. The number of recalled drugs in the first quarter of 2013 is higher than the average number of drugs recalled in the 2012 year.
Unit recalls also increased to more than 13.1 million units, as compared with the last quarter of 2012 during which 11.7 million units were recalled.
The increase in FDA inspections is a response to the meningitis outbreak in 2012, when more than 700 patients became ill and over 50 patients died. In addition to drug compounding companies, large drug companies have recalled significant numbers of drugs as well. These companies include Hospira and Novartis.
Recalls Jump 32% in First Quarter: More than 100 Prescription Drugs Affected, but OTC Recalls Include Large Numbers
Dr. William Warburton has filed a lawsuit against the British Columbia Ministry of Health because the agency allegedly restricted funding into drug safety research as a result of financial conflicts of interest with political donors and pharmaceutical companies. Dr. Warburton is a health data researcher who was contracted by the Ministry of Health in British Columbia to conduct complex data analyses on patient health outcomes from atypical anti-psychotic medications.
The analyses for which Dr. Warburton was contracted "...included investigation of harmful side-effects, including mortality, and risk assessment of drugs purchased by the province through its programs, and had the potential of disrupting financially significant payments to large pharmaceutical companies, many of whom were major contributors to the Liberal Party who formed the government in the Province" (see lawsuit here).
Dr. Warburton was required to conduct these analyses on very profitable medications (see below) after the Province had developed programs and financing to attract these companies to British Columbia. Additionally, the Liberal Party received sizable donations from these same drug companies. The lawsuit states that the Province sought to "...end the investigation of harmful effects of drugs which risk leading to diminishing payments to their political contributors."
To maintain good standing with the pharmaceutical companies and to prevent the potential loss of sales as a result of the research findings, Dr. Warburton's access to the data sets, which he was contracted to analyze, were revoked. He was then fired and the Province cut funding to other drug safety and analysis programs, such as Therapeutics Initiative at the University of British Columiba, that conducted similar work.
Dr. Warburton was contracted to conduct analyses on data for the following medications:
Abilify (aripiprazole) - Bristol Myers Squibb
Seroquel (quetiapine) - AstraZeneca Canada Inc.
Risperidal (risperidone) - Janssen Inc.
Zeldox (ziprasidone) - Pfizer Canada Inc.
Invega (paliperidone) - Janssen Inc.
Clozaril (clorzapine) - Novartis Pharmaceuticals Canada Inc.
Read the lawsuit here: Warburton v. Province of British Columbia and MacDiarmid, 2013
Drug Safety Research in Canada and Political Donations
Canadian Agency Freezes Funding To Drug Safety Group