by brant bullard | Dec 1, 2015 | News
Plavix Clopidogrel
Plavix is an anti-clotting medication, used to prevent blood clots that can lead to heart attacks or strokes in certain patients. It only works once it is converted or metabolized into its active form (clopidogrel) by the liver enzyme CYP2C19.
But on March 19th, 2014, Hawaii Attorney General David M. Louie filed suit against the manufacturers of the popular drug Plavix®. Louie claims that the manufacturers knew and did not disclose that the medication would be ineffective or only partially effective in certain patient populations due to genetic variations.
Plavix is metabolized by the drug-processing enzyme CYP2C19. Certain genetic variations can affect the activity of this enzyme. Patients with these variations are at a higher risk of treatment failure or adverse drug events, even on a normal dose.
Hawaiians would be especially vulnerable to treatment failures due to the state’s ethnic makeup. It’s estimated that between 38-79% of Pacific Islanders and 40-50% of East Asians would have these variations. These two ethnicities together made up 48.6% of the Hawaiian population according to the 2010 census.
The FDA added a boxed warning to Plavix in 2010, which warned about diminished efficacy in poor metabolizers, however, the Hawaii Attorney General alleges that Bristol-Myers Squibb and Sanofi-Aventis, Plavix’s manufacturers, knew about the risk as early as 1998 and failed to inform the public. He is seeking $10,000 for each deceptive or unfair act, plus an additional $10,000 for each act directed towards the elderly, as well as the disgorgement of $10 million in profits from Plavix sales in Hawaii.
Plavix is a common medication prescribed to prevent blood clots. It’s estimated that 115 million patients take the prescription worldwide with 50 million inside the United States. Plavix sales were worth $6.6 billion in 2011. Hawaii is the fifth state to sue the manufacturers of Plavix. California, Louisiana, Mississippi and West Virginia have also filed their own lawsuits. The manufacturers have declined to comment on the lawsuit. The U.S. Department of Justice is also now investigating.
Whether or not these lawsuits are successful in the courts, this may signal the beginning of a sea-change in the way drug manufacturers create and market their medications. The public has shown a greater interest in individualized therapies and a reaction against block buster development. According to the New England Healthcare Institute, adverse drug events may cost US healthcare system nearly $300 billion each year. Better development practices on the part of manufacturers may help alleviate some of that burden.
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Fifty-two plaintiffs sue Plavix maker Bristol-Myers Squibb in St. Clair County
Sep 18, 2012
The makers of the popular medication, Plavix face a St. Clair County lawsuit filed by 52 people who claim they suffered strokes and heart attacks after taking the drug.
Touted as a “super aspirin,” Plavix can allegedly cause heart attacks, internal bleeding, strokes, blood disorders or death, according to the recently filed complaint.
Lead plaintiff Mary Miller and 51 others claim they suffered such maladies after taking Plavix, a drug manufactured by defendants Bristol-Myers Squibb Company and Sanofi Aventis.
Christopher Cueto and Michael Gras of the Law Office of Christopher Cueto in Belleville; Robert L. Salim of Salim-Beasley in Natchitoches, La., and Julie B. Isen of The Miller Firm in Orange, Va., will be representing them.
The plaintiffs say they began taking the drug after its makers promoted the drug to be more effective than aspirin to prevent heart attacks and strokes. In addition, the companies said the drug “would give a person even greater cardiovascular benefits than a much less expensive, daily aspirin while being safer and easier on a person’s stomach than aspirin,” the suit states.
In addition, Bristol-Myers Squibb and Sanofi allegedly marketed their drug as safe for use with aspirin, although such a claim had not been established, the complaint says. In fact, the claim has been proven false, and the combined therapy is even more dangerous in patients who do not have peripheral arterial disease and acute coronary syndrome, the plaintiffs allege in their complaint.
The FDA has cracked down on Bristol-Myers Squibb and Sanofi a number of times for this and other marketing ploys that misinformed patients and their physicians, according to the complaint.
“The result is that physicians are prescribing Plavix to people who could be cheaply and effectively protected against ischemic events by a simple aspirin, than to pay approximately $4.00 a day for a dose of Plavix,” the suit states.
“Defendants’ nearly eight-year run of misleading physicians and to the public about the safety and efficacy of Plavix for the sole purpose of increasing corporate profits is evidenced by these scientific studies that reveal that not only is Plavix not worth its high price — it is dangerous.”
Bristol-Myers Squibb and Sanofi have sold $3.8 billion worth of Plavix annually, the plaintiffs claim.
In addition to their exaggerated marketing claims, the makers of Plavix failed to adequately warn of the dangers of the drug in package inserts included in the medication’s packaging, the suit states.
“Despite the growing body of scientific knowledge that the four-dollar Plavix pill was not much better than a four-cent-a-day aspirin, Defendants kept promoting it to the public and to physicians, using hyperbole and outright falsification in the process,” the suit states.
Because of the defendants’ actions, the plaintiffs have suffered severe and permanent injuries in addition to their heart attacks, strokes, excessive bleeding and stent replacements, the complaint says. They also suffered physical impairment, disfigurement, physical pain and suffering; lost their enjoyment of life; and incurred medical costs, the plaintiffs claim.
In their complaint, the plaintiffs allege strict products liability, manufacturing defect, failure to warn and negligence against the defendants.
The plaintiffs seek economic and compensatory damages, plus costs, attorney’s fees and other relief the court deems just.
St. Clair County Circuit Court case number: 12-L-455.
Plavix Hemorrhage Plaintiffs Head to Court
October Filings
Plavix lawyers at Pintas & Mullins report that dozens of plaintiffs have filed suit against manufacturers Sanofi and Bristol-Myers Squibb over the blood-thinner Plavix (clopidogrel). Patients in the U.S. and abroad are claiming the drug made them develop autoimmune diseases and suffer severe hemorrhages.
U.S. plaintiffs took their claims to New York state court recently after taking Plavix to recover from strokes, stent placements, and other medical events requiring blood-thinning medications. Patients require blood-thinners to keep blood from creating dangerous, potentially fatal clots in veins and arteries.
Our Plavix attorneys recently reported that the consumer watchdog group Public Citizen requested that the FDA place a Black Box Warning, the agency’s most severe caution, on the drug’s labels. Public Citizen cited several studies which found that patients taking Plavix for long periods of time (at least one year) not only failed to improve in health, but had an increased risk of fatal internal bleeding as well. Plavix already includes a Black Box warning, implemented in 2010, which tells consumers that 2 to 14% of the population cannot properly metabolize the drug and will not benefit from its use.
Indeed, recent medical breakthroughs have shown that nearly a third of the millions of patients taking Plavix have a genetic variant of the enzyme needed to convert the drug to its active form. This means that one-third of those paying $4 a pill for Plavix are not benefitting from it, and are unnecessarily at an increased risk from blood clots and fatal bleeding episodes. Had the drug been subjected to a more rigorous approval process, this surely would have been made known sooner.
The complaints filed by plaintiffs in New York are all common in that they accuse Plavix of being defective and dangerous for human health. They also accuse Sanofi and Bristol-Myers of advertising a drug unfit and unsuitable for consumption, and for placing profits over patient safety in expediting Plavix’s approval in the U.S.
Plavix submitted an application to the FDA for approval after only one clinical study had been conducted. After a rare priority regulatory review, the FDA approved Plavix in 1997, however, several members of the federal panel expressed concerns about the drugs’ actual benefits. They were not convinced that Plavix was any more effective than over-the-counter Aspirin. As additional studies were conducted on the drug, this concern was brought to light and eventually confirmed.
Despite this, by 2012, Plavix was the world’s second-best-selling medicine, due in no small part to Sanofi and Bristol-Myers’ deep pockets and masterful (and illegal) marketing campaigns. In July 2013, over three dozen Plavix users and their families sued the drug makers over allegations that they pushed physicians to over-prescribe the drug. They claim that the companies knowingly ignored clinical evidence that Plavix was no more beneficial than Aspirin and carried severe, life-threatening risks.
These lawsuits also include the master complaint filed against Plavix in 2012 on behalf of those who died or became severely ill after using the blood thinner. This master complaint argues that Plavix was improperly labeled and failed to warn patients of the dangers associated with its use.
Other lawsuits regarding Plavix stem from accusations of off-label marketing. These suits allege that the drug makers created and acted on a scheme to market Plavix as superior to its competitors despite this falsehood. This fraudulent marketing caused several government health programs, such as Medicare, to pay for prescriptions they otherwise would not have.
Further compounding its legal woes, Sanofi and Bristol-Myers are also accused of manipulating clinical trial data to support its marketing claims of superiority. Plaintiffs claim the companies also knowingly downplayed the drugs’ side effects and health risks, which include the risk of developing haemophilia, a rare autoimmune disease.
Plavix attorneys at Pintas & Mullins have decades of experience in pharmaceutical litigation and are currently reviewing cases concerning Plavix injuries and wrongful death. If you or a loved one was prescribed Plavix and suffered a serious bleeding episode, you may be entitled to compensation for your medical bills and lost wages, and should contact an experienced attorney as soon as possible.
The attorneys at Morgan & Morgan are investigating potential lawsuits on behalf of Plavix users who suffered serious injuries, including internal bleeding. It has been alleged that the drug’s manufacturer falsely advertised that Plavix provides superior cardiovascular benefits to those of aspirin and failed to properly warn consumers about the severe risks of taking the drug, which may include heart attack, stroke, gastrointestinal bleeding, cerebral hemorrhaging and death.
Plavix Linked to Serious Injuries
Plavix has been linked to a number of serious injuries including the following:
Recurrent and bleeding ulcers: Plavix users develop 12 times as many ulcers as those taking aspirin in combination with heartburn pill Nexium, according to a study published in a New England Journal of Medicine. This study suggests that Plavix users should consider switching to a cheaper and potentially safer alternative, such as aspirin plus a heartburn pill, according to some doctors.
Thrombotic Thrombocytopenic Purpura (TTP): A study published in 2000 in the New England Journal of Medicine reveals that even short-term use of Plavix can increase the user’s risk of developing Thrombotic Thrombocytopenic Purpura. TTP is a rare disorder of the blood-coagulation system which causes blood clots to develop in small blood vessels throughout the body. TTP can cause heart, brain and kidney damage.
Heart Attack, Stroke and Death: Plavix is designed to prevent blood clots in people who have recently suffered a heart attack or stroke, as well as those suffering from certain heart or blood vessel disorders; however, research has suggested that, in some patients, the drug may increase the risk of a heart attack or stroke – the conditions it was designed to prevent.
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File your Plavix Complaint and seek compensation:
Patients who take Plavix to ward off heart attack or stroke may find that the risk of Plavix side effects is greater than the potential benefit. Studies suggest a link between Plavix and bleeding and a risk of Plavix interactions with other medications. Patients who have been harmed by use of Plavix may be eligible to file a Plavix lawsuit against the drug’s maker.
REE CASE EVALUATION
Plavix Clopidogrel
Plavix is an anti-clotting medication, used to prevent blood clots that can lead to heart attacks or strokes in certain patients. It only works once it is converted or metabolized into its active form (clopidogrel) by the liver enzyme CYP2C19.
Normally, platelets in the blood clump together and form blood clots that stop bleeding. However, in some patients, these platelets clump together in narrow arteries, resulting in a clot in the artery, which can prevent proper blood flow. When blood flow is stopped in arteries that lead to the brain, the brain does not receive an adequate supply of oxygen, which can cause a transient ischemic attack. When arteries to the heart are blocked for a short time, patients experience angina (chest pain). When that blockage occurs for longer, patients experience a heart attack.
Plavix is prescribed to help prevent blood clots from forming in the arteries. The top-selling drug is made in the US by Bristol-Myers Squibb and internationally by Sanofi-Aventis.
Plavix Warnings
On November 28, 2009, the US Food and Drug Administration (FDA) issued a warning that patients who take Plavix should avoid using Prilosec or Priolosec OTC (omeprazole). The warning was issued because the FDA was concerned that when taken together, Plavix’s effectiveness was reduced by approximately half.
“Patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec,” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
Because Plavix does not work properly until it is converted or metabolized into its active form by the liver enzyme CYP2C19, Prilosec’s blocking of that enzyme reduces the effectiveness of Plavix. According to the FDA, information provided by the manufacturers supported “the existence of a significant interaction that could negatively impact a person’s health.”
Other drugs that patients are urged to stay away from while taking Plavix include Nexium, Tagamet and Tagamet HB, Diflucan, Nizoral and Prozac.
Plavix CHARISMA Study
In 2006, a study published in The New England Journal of Medicine called the Clopidogrl for High Atherothrombotic Risk and Ischemic Stabilization Management and Avoidance (CHARISMA) study found that there was no added benefit to treating patients with both clopidogrel and aspirin combined as compared with aspirin and a placebo.
Researchers further found that in a subgroup of participants who were given the combined medications as a preventative measure, but were not symptomatic of stroke or heart attack, the risk of moderate to severe bleeding increased. Furthermore, the risk of death increased in patients who were given clopidogrel. Among asymptomatic patients, the rate of death from cardiovascular causes was 3.9 percent among those who were given clopidogrel and 2.2 percent among those given a placebo.
Plavix Stomach Bleeding
A study published in The New England Journal of Medicine (as reported by The New York Times; 01/20/05) found that patients taking Plavix suffered 12 times more ulcers than patients who took aspirin plus a heartburn medication. Many patients were reportedly put on Plavix because it was believed to have lower rates of ulcers than aspirin, a belief that was reportedly undermined by the study. The study found that of patients who took Plavix during the analysis, 8.6 percent had a bleeding ulcer during a 12-month period, while 0.7 percent of those given aspirin and Nexium had a bleeding ulcer.
Researchers recommended that some patients who took Plavix be switched to aspirin and a heartburn medication because the aspirin not only appears safer, but is also reportedly less expensive than Plavix.
For more information on pharmacogenetic testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
Source: Hawaii.gov
fda.gov
wsj.com
New England Journal of Medicine
by brant bullard | Nov 4, 2015 | News
LeadingAge Oklahoma – Living Better…Longer!
As part of an ongoing effort to provide quality care to seniors across Oklahoma, we asked leaders in the industry to give us their perspective on Metabolic Validation. A no-cost resource that is available to help guide communities and their healthcare professionals in day-to-day patient care.
Executive Perspective – Metabolic Validation
By: Don Blose, CEO, Spanish Cove
As the CEO of Spanish Cove and having a background in public health, I understand the value of preventative medicine approaches. Long life is highly valued and medicine has helped extend us. However, for too many, the gap between quantity and quality of life is broad. I feel it is our calling as providers, to search for and promote opportunities to narrow the gap and decrease vulnerabilities associated with seniors. I see the Metabolic Validation program as a component of the toolbox that can help reduce this gap.
Last year, our facility partnered with PGx Medical and implemented the Metabolic Validation Program – a tool designed to efficiently and more accurately manage medications in a clinic, long term care or assisted living facility.
At Spanish Cove, our Assisted Living clinical staff provides oversight and assistance for residents experiencing a loss of ADL functioning. The staff helps to maintain (or improve) each residents’ independence. Metabolic Validation testing was one way we reduced unnecessary medications that could negatively impact our residents’ quality of life and ADL functioning.
We are wellness focused at Spanish Cove. We utilize various programs and tools such as: Tai Chi & yoga for better balance; stretch & strengthening classes to improve strength, endurance & flexibility; and, activities to promote cognitive functioning. My community is predominately an independent living community. Our goal is to encourage people to live longer…better!
We consider the Metabolic Validation Program to be a useful aid in promoting improved quality of life. The program gives us added confidence in our efforts to ensure our community is healthier and happier.
If you haven’t implemented the Metabolic Validation Program in your senior community, I would encourage you to check into it. It is a no-cost resource (covered by Medicare B and Medicaid with no balance bill) and it will help reduce unnecessary medications and has the potential to help improve the quality of life of your residents. We have not seen any downside to the test.
For more information on the PGx Medical Metabolic Validation Program, call 405-509-5112 or email: info@pgxmed.com
by brant bullard | Nov 3, 2015 | News
As we continue to educate and implement our pharmacogenetic program across the country, we want to let you know what pharmacogenetics is not…
Pharmacogenetics is the study of inherited genetic differences in drug metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects.
What Pharmacogenetics is not:
1) It is not for everyone. While some companies will say you need to test everyone in your entire facility, we disagree. It is our belief that pharmacogenetic testing is only for those with medical necessity. By identifying patients who are currently diagnosed with a disease or a, family history of, currently being prescribed, or previously prescribed any medications in any of one or combination of the following disease state categories:
Neuro: Anxiety, Anti-depressants, Psychosis, or ADHD, Analgesic/Pain (migraine, neuropathic, arthritis, musculoskeletal)
Cardiovascular: Arrhythmia, Hyperlipidemia, Anti-coagulants, Hypertension or Cardiovascular
Thrombophilia: History of clotting issues, stroke concern predication to falls
2) It is not a “tell all” final answer for dosing. Pharmacogenetic testing was designed to be a long term medication management “tool” for healthcare professionals. It is a guide to help with dosing of current medications, and a roadmap for the future. It is a once-in-a-lifetime test that will help in medication management and allows the healthcare team to see into an individual’s body to help determine if that individual can metabolize medications as intended by the drug manufacturer. It helps determine therapy for each patient – individualized care.
3) It is not all the same. As we travel around the country educating healthcare professionals of the tools and resources available, we are finding that not all companies offer the same program. The PGx Medical Metabolic Validation Program is the most easily implemented and has the largest number of genes tested. Both of these are important as you want to maximize this one time test with as much info as you can get, and be able to read it and make sense of how to use it with each resident. Also, PGx Medical will come along side your staff after testing to help interpret and implement results of the testing.
4) It isn’t a way to drain the medicare system. As we educate healthcare professionals, one common question is, “Is this draining the medicare system?” and the answer is no. CMS reimburses 100% for anyone with Mediare B and most private insurance providers cover the program with normal co-pays and deductibles. They reimburse because they see the program as a “cost savings” long term. One month of Abilify alone can be upwards of $1,000/month. And what if a patient doesn’t even have the ability to metabolize the medication? They are getting no therapy from the drug so it is wasteful spending – with no outcome. And most seniors are on approximately 6-8 perscription medications, so it is a cost savings to make sure they are on the proper medications. Not to mention falls, re-hospitalization and other issues related to drug-interactions or being over medicated.
Know what
pharmacogenetics isn’t so you can see and utilize the real benefits and value of this no-cost program.
For more information, or to schedule an appointment for education and implementation, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
Jennifer Flowers, a medication aide at McMahon Tomlinson Nursing & Rehabilitation Center, carefully sorts medications for patients.
