http://www.annallergy.org/article/S1081-1206%2811%2900901-X/abstract
Eric Macy, MD, Southern California Permanente Medical Group, Department of Allergy, San Diego Medical Center, San Diego, California
Ngoc J. Ho, PhD, Kaiser Permanente Healthcare Program, Department of Research and Evaluation, Pasadena, California
Background
Population-based data on the demographics and clinical characteristics of patients with multiple unrelated drug class intolerances noted in their medical records are lacking.
Objectives
To provide population-based drug “allergy” incidence rates and prevalence, and to identify individuals with multiple drug intolerance syndrome (MDIS defined by 3 or more unrelated drug class “allergies,” and to provide demographic and clinical information on MDIS cases.
Methods
Electronic medical record data from 2,375,424 Kaiser Permanente Southern California health plan members who had a health care visit and at least 11 months of health care coverage during 2009 were reviewed. Population-based drug “allergy” incidence rates and prevalence were determined for 23 unrelated medication classes.
Results
On January 1, 2009, 478,283 (20.1% health plan members had at least one reported “allergy.” Individuals with a history of at least 1 “allergy” and females, in general, reported higher population-based new “allergy” incidence rates. Multiple drug intolerance syndrome was present in 49,582 (2.1% . The MDIS cases were significantly older, 62.4 ± 16.1 years; heavier, body mass index 29.3 ± 7.1; and likely to be female, 84.9%, compared with average health plan members. They had high rates of health care utilization, medication usage, and new drug “allergy” incidence. They sought medical attention for common nonmorbid conditions.
Conclusions
Multiple drug intolerance syndrome is in part iatrogenic. It is associated with overweight elderly women who have high rates of health care and medication usage. Urticarial syndromes only explain a small fraction of MDIS cases. Multiple drug intolerance syndrome is associated with anxiety, but not predominately with immunoglobulin E (IgE -mediated allergy or life-threatening illness. Multiple drug intolerance syndrome can be managed by medication avoidance and judicious rechallenge.
A pill costing ?1.40 a day “could save the lives of thousands of heart disease patients”, according to the Daily Mail.
Several other newspapers have reported on the drug ivabradine, known by the brand name Procoralan, as European drug regulators have today approved it for the treatment of chronic heart failure. In heart failure, the heart is unable to pump sufficient blood to the limbs and organs, causing a range of unpleasant symptoms such as weakness and breathlessness.
The drug is already used to treat some patients with a form of heart-related chest pain called angina. After an examination of evidence by the European Medicines Agency (EMA , ivabradine has also been granted a “marketing licence” for the treatment of chronic heart failure. This will allow ivabradine’s manufacturer to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, its treatment effects and cost effectiveness will need to be assessed by the National Institute for Health and Clinical Excellence (NICE .
Despite all the positive news coverage, prescribers will need to consider both the effectiveness and cost of ivabradine compared to other treatments for heart failure. It’s possible that other drugs could perform as well or better for less cost.
What is ivabradine used for?
Despite what some news reports suggest, ivabradine is not a new drug. It is already used to treat the symptoms of long-term stable angina. It is not the first choice for treating stable angina, and NICE guidelines recommend that it is only prescribed to people who cannot take beta-blockers or calcium channel blockers, which are generally preferred to treat angina.
The drug has made the papers because it has now been granted a licence for the treatment of some types of chronic heart failure. Although it has previously been approved for treating stable angina, drugs must be licensed for each of their specific uses. In August 2010, Behind the Headlines reported on a randomised controlled trial that looked at ivabradine for heart failure.
What is heart failure?
Contrary to what the term implies, heart failure does not mean that somebody’s heart has stopped beating or misses beats. Instead, it refers to a chronic condition where the heart can no longer pump sufficient blood around the body.
During each heartbeat, blood enters the heart and is pumped out towards the organs and limbs. In heart failure, the heart cannot cope with pumping the normal amount of blood in each heartbeat. This can be due to the lower chambers of the heart (the ventricles not contracting properly so that blood is not completely pumped out of the heart (systolic heart failure or because the ventricles do not fill up with enough blood between each heartbeat (diastolic heart failure . It can be a combination of the two. It may affect the left or right side of the heart, or both sides. It can cause a range of symptoms, including breathlessness, tiredness, weakness, dizziness, nausea, swollen ankles and legs, enlargement of the liver, constipation and loss of appetite.
Risk factors or causes of heart failure include:
- ischaemic heart disease (coronary heart disease
- diseases of the heart muscle or heart valves
- abnormal heart rhythms
- high blood pressure (hypertension
Around 68,000 new cases of heart failure are diagnosed in the UK each year.
How does ivabradine work?
Ivabradine slows the heat rate. This may have a protective effect on the heart, and allow the heart to pump more efficiently at a slower rate.
Is it suitable for everyone?
The European Medicines Agency (EMA , which is responsible for issuing the authorisation, says that ivabradine is medically suitable for people with:
- long-term heart failure with symptoms (a severity of symptoms called NYHA II to IV
- the form of the illness involving systolic dysfunction (where blood is not completely pumped out of the heart
- a regular rhythm and a heart rate of 75 beats a minute or more
The EMA says that when treating heart failure, ivabradine can be given either in combination with standard therapies, including beta-blockers, or on its own when beta-blocker therapy is not suitable or not tolerated.
The EMA also states that ivabradine should not be used for patients who have:
- unstable or acute heart failure, also known as “new onset” heart failure
- a heart rate imposed exclusively by a pacemaker
Ivabradine is also unsuitable for people who:
- react to any of the components of the tablets
- have a heart rate below 60 beats a minute before treatment
- have very low blood pressure
- have various types of heart disorder (cardiogenic shock, a history of acute heart attack, rhythm disorders or unstable or acute heart failure or have unstable angina or a pacemaker
- have liver problems
- are taking certain other drugs
- are pregnant or breastfeeding
Are there any side effects?
The most common side effect of ivabradine is a temporary brightness in the field of vision. Other common side effects (affecting 1 in 100 people or more include:
- blurred vision
- headaches
- changes in electrical activity of the heart
- heart or circulation problems
- dizziness, tiredness, weakness, lowered blood pressure, general feeling of being unwell, fainting or brief losses of consciousness
Is ivabradine available now?
Ivabradine is available now for the treatment of long-term stable angina, having been approved for this use several years ago. It is in the news because it has now been granted “marketing authorisation” by the EMA as a treatment for heart failure. This allows the manufacturer of ivabradine to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, it will need to be approved by NICE.
What kind of things will NICE have to consider?
NICE will consider the cost effectiveness of ivabradine treatment (how its medical effectiveness relates to the cost of the drug . It should not be assumed that ivabradine will become the standard treatment for heart failure. Other drugs may be more effective or less likely to cause side effects, and therefore better options.
While several newspapers have reported that the drug is cheap at just ?1.40 a day, this is higher than many beta-blocker drugs currently in use, which may cost just a few pounds a month. If these existing drugs can provide similar or better results to ivabradine for a lower price, then it is likely they will remain the default option for prescribers.
Links To The Headlines
The ?1.40 heart pill lifesaver: 10,000 patients a year could be saved by newly-licensed drug. Daily Mail, March 6 2012
Ivabradine, the lifesaving ?1.40 heart pill, gets European approval. The Daily Telegraph, March 6 2012
Wonder drug hope: ?10-a-week treatment cuts risk of heart failure by 39%. Daily Mirror, March 6 2012
Heart drug approved by European regulators. The Guardian, March 6 2012
Drugs being developed for the treatment of diseases of the central nervous system (CNS take 35% longer to complete clinical trials and receive regulatory approval than other new prescription medicines, according to a new analysis.
Between 1996 and 2010, the mean clinical-plus-approval-phase time for CNS drug treatments approved in the US was 32 months, 35% longer than the mean for non-CNS drugs approved during the same period, according to the analysis, which is published by the Tufts Center for the Study of Drug Development (CSDD .
But despite the longer and more costly development associated with CNS drugs, "the CNS new product pipeline is among the richest in the R&D-based drug industry," comments Joseph DiMasi, who conducted the study and is director of economic analysis at the Tufts Center.
The industry's CNS drug pipeline includes products to treat neurological diseases such as Alzheimer's disease, epilepsy, migraine headaches and stroke, and mental health conditions such as addictions, autism, depression, panic and schizophrenia.
The pipeline has grown by an annual average of 6% over the last decade and currently accounts for 11% of all drug development projects worldwide, the study notes. Nevertheless, development of these treatments poses a challenge for drugmakers, with the clinical approval success rate for "self-originated" CNS drugs entering clinical trials between 1993 and 2004 estimated at about one in 10. That compares to around one in six for all self-originated drugs, according to the study, which goes on to explain that "self-originated" drugs are those developed entirely by one manufacturer, in contrast to compounds which a company may obtain through licensing, purchase or other means.
Also, the "clinical approval success rate" refers to the share of New Chemical Entities (NCEs in clinical development that eventually obtain marketing approval from the US Food and Drug Administration (FDA .
The analysis is reported in the March/April issue of the Tufts CSDD Impact Report. It also reveals that the clinical approval success rate for self-originated CNS drugs varied from a low of 7.1% for products entering clinical testing during the period from 1995 to 2000 to 14.8% - or more than double - for drugs which entered clinical testing during 1998-2003.
It also notes that the mean clinical time for CNS drugs during 1996-2010 was 102.1 months, which is 40% longer than for non-CNS drugs, while the mean approval time for these products was 20.3 months, or 13% longer than for non-CNS treatments.
“Ice cream 'could be as addictive as cocaine',” reported the Daily Mail. In a bid to scoop its rivals, the newspaper claimed that new research had whipped up “concerns that the dessert could be genuinely addictive”.
It’s not clear who exactly had these chilling “concerns” over the possible addictive qualities of the frozen snack, but the study in question looked at measures of brain activity in 151 teenagers while they drank an ice cream milkshake. During the scans, teenagers who had frequently eaten ice cream over the past two weeks showed less activity in the “reward areas” of the brain that give pleasurable sensations. This reduced reward sensation was reported to be similar to what is seen in drug addiction as users become desensitised to drugs.
Unsurprisingly, the study did not directly compare brain responses to or cravings for ice cream with those for illegal drugs. Therefore, while some aspects of the brain’s response may be similar, it is not correct to say that this study has found that ice cream is “as addictive” as illegal drugs.
It should be noted that the study included only healthy teenagers of normal weight, and its results may not represent overweight or older people. It also only tested one food, so the results may not apply to other foods.
Where did the story come from?
The study was carried out by researchers from the Oregon Research Institute in the US. Sources of funding were not clear. The study was published in the peer-reviewed American Journal of Clinical Nutrition.
The newspapers focused on the suggestion that ice cream is “as addictive” as drugs. However, it is not possible to conclude this from the study.
What kind of research was this?
This experimental study looked at whether regularly eating ice cream reduces the brain’s pleasurable “reward” response. When we do things that support our survival, such as eating and drinking, the brain gives us a pleasurable reward sensation, reinforcing this behaviour and encouraging it in future. A similar process is also believed to occur in drug addiction, where a person’s reward response to the drug decreases with repeated exposure, leading to a need to take more of the drug.
The researchers reported that people who are obese experience less of a response to food in the reward centres of the brain, which may contribute to over-eating. Repeatedly eating foods with high levels of calories (called “energy dense” foods has also been shown to lead to brain changes that reduce reward response in rats. The researchers wanted to see if a similar thing happens in humans, by looking at whether regularly eating ice cream reduces the brain’s pleasurable reward response to an ice cream milkshake.
What did the research involve?
The researchers recruited 151 adolescent volunteers who were not overweight. They asked them how often they ate ice cream, and carried out brain scans while they drank either a tasteless solution or an ice cream milkshake. They then looked at whether the volunteers who ate ice cream frequently showed less brain activity in the reward centres of the brain when drinking the ice cream milkshake.
The study excluded any individuals who were overweight or had reported binge eating in the past three months, as well as any who had used illegal drugs, took certain medications, had a head injury or a mental health diagnosis in the last year. The volunteers completed standard food questionnaires about their eating habits over the past two weeks, including how often they ate ice cream. They also answered questions about food cravings and how much they liked certain foods, including ice cream. The volunteers also had their weight, height and body fat measured.
Volunteers were asked to eat their meals as usual but not to eat anything for five hours before the brain scan. The researchers then gave them either a sip of chocolate ice cream milkshake or a tasteless solution, and monitored the activity in their brain. Each participant received both drinks in a randomised order. The researchers then looked at what happened in the brain during each drink, and whether this varied depending on how much ice cream the volunteer usually ate. They also looked at whether body fat or energy intake from other foods influenced the response.
What were the basic results?
The researchers found that when the volunteers drank the ice cream milkshake, it activated the parts of the brain involved in giving a pleasurable “reward” feeling. Volunteers who ate ice cream frequently showed less activity in these pleasurable reward areas in response to the milkshake. Percentage of body fat, total energy intake, percentage of energy from fat and sugar, and intake of other energy-dense foods were not related to the level of reward response to the milkshake.
How did the researchers interpret the results?
The researchers concluded that their findings show that frequent consumption of ice cream reduces the “reward” response in the brain to eating the food. They reported that a similar process is seen in drug addiction.
The researchers also said that understanding these sorts of processes could help us understand how changes in the brain may contribute to, and help maintain, obesity.
Conclusion
This brain-scanning study suggests that the brain’s pleasurable reward response to ice cream decreases if it is eaten frequently. There are some points to note:
- The study only included healthy adolescents who were not overweight. Its results may not be representative of overweight or older individuals.
- The study only tested one food, so the results may not apply to other foods.
- Volunteers’ eating habits were only assessed for the past two weeks, and these may not be representative of their long-term eating habits.
- The study did not look at any other food with a discernable taste, only a “tasteless liquid”. It would have been interesting to see whether the reward response with tasting other foods, including less energy-dense foods, also diminished over time.
- News reports claimed that this study shows that ice cream is “as addictive” as illegal drugs, but this is not the case. While the reduced brain reward seen with frequent ice cream eating was reportedly similar to that seen in the use of addictive drugs, the study unsurprisingly did not directly compare brain responses to ice cream and illegal drugs, or their addictive potential.
Analysis by Bazian
Links To The Headlines
Ice cream 'could be as addictive as cocaine', as researchers reveal cravings for the two are similar. Daily Mail, March 5 2012
Ice cream as 'addictive as drugs' says new study. The Daily Telegraph, March 5 2012
Links To Science
Burger KS and Stice E. Frequent ice cream consumption is associated with reduced striatal response to receipt of an ice cream–based milkshake. February 15 2012
"That's not even a quarter of their profits," said Copeland, a law professor at
Pennsylvania State University. "I was up in arms."
Government officials say they are, too, and they've talked about incorporating some of Copeland's ideas.
"That's a question we've been struggling with for the last couple of years," said Gregory Demske, assistant inspector general for legal affairs at Health and Human Services. "We recognize there's a problem."
If a company is excluded from doing business with the government, then medications that only those companies produce will not be available to beneficiaries. But, Copeland said, the fees associated with corporate integrity agreements haven't been enough to keep companies from bilking the government again.
"It's still in the company's interest to promote off-label marketing because they're still going to make more in profits than they lose in fines," she said.
HHS officials are talking with those at the
Justice Department and Food and Drug Administration to fix the problem, Demske said.
Most of the cases come from off-label marketing of prescription medications. For example, Pfizer was accused of marketing Bextra, a painkiller, for uses other than what the
FDA had approved. Such uses constitute fraud because they take government money for purposes the FDA has not approved.
Instead of excluding an entire company from doing business with the government, Copeland said, the drug being marketed off-label could be excluded.
HHS officials considered that, Demske said, but they needed to ensure that beneficiaries could get their medications. The agency is considering taking away a company's patent rights as part of a settlement with the government.
That, he said, would allow other companies to make and sell the drugs to the government. Such a deal could be negotiated with companies as part of a fraud settlement and would not require congressional approval.
"We could require other things if the defendant will agree to it," he said. "If not, there might not be a settlement."
And if there's no settlement, there may be an exclusion.
Copeland suggested requiring companies to conduct clinical trials for the off-label uses they were accused of, requiring that they license a product to other manufacturers and holding high-level individuals criminally liable. Demske said that investigators began going after individuals in companies in 2010 and that they have focused resources on that idea.
Pfizer,
Bristol-Myers Squibb and
Abbott Laboratories did not respond to questions from USA TODAY.
"Imposing such a severe penatly on a person who had no knowledge of the wrongdoing at issue is manifestly unfair and unjust," said
Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.
The Supreme Court ruled in the 1970s that the government may go after officials who should have knowledge that fraudulent behavior is happening under their management. However, the law applies only to individuals holding a position at a company.
"If they leave, we can't reach them," Demske said. "The law is written in present tense."
The government has to send a note notifying the person that it is considering excluding them, which leaves the person plenty of time to leave the company.
"They would be free to work elsewhere," Demske said.
A bill to address the problem passed the House last year but hit the Senate too late in the session to make it to a vote. A new bill, HR 675, has been introduced.
Officials with the Centers for Medicare and Medicaid Services are looking for answers, said Ted Doolittle, deputy director of CMS' Center for Program Integrity. Instead of excluding a company, the CMS can revoke payment, which the government plans to do more aggressively, he said.
Last month, 78 home health care agencies in Texas were suspended in connection with a fraud case, and Doolittle said the CMS will not pay them for services until they are cleared of wrongdoing. First, he said, the CMS had to make sure beneficiaries would be able to get the services they need if those centers were out of business.
Congress members have suggested mandatory exclusions for crimes, but Copeland said the cases often don't reach that point because the parties settle before a proclamation and because the government has to worry about patient access.
If the government targeted individuals more aggressively, that could send a powerful message to drug companies, said Stan Twardy, leader of law firm Day Pitney's health care compliance group.
"Something called a jail is going to send a lot stronger signal than a fine," he said. "The regulations can change, but individuals and companies will take advantage of any loopholes they may find. It's part of that game of maximizing profits."
Under a system of agreements and fines, he said, the corporate culture will remain the same.
Copeland said she doesn't think that's enough.
"If you go after the sales manager because the sales manager could have prevented the fraud, it doesn't change the corporate culture," she said. "The more prescriptions, the more money you make, so the incentive remains."
Patrick Burns, spokesman for the non-profit Taxpayers Against Fraud, said although there may be differences of opinion, there is a greater sense or urgency about fighting the problem.
"We're all thinking the same thing," Burns said of investigators and Congress members. "The good news is they're pushing to actually do it."
Researchers are looking for women who took part in a Leeds-based trial of antidepressant drugs in 1983.
The study had to be stopped after the participants suffered extreme side effects - and now experts want to know whether they had long-term problems.
Psychiatrist Prof David Healy is leading the search for the 12 women who tested the drug sertraline.
He said: “If alive, the women would be between 56 and 72. They may be living near Leeds still.”
The study was carried out by the-then Human Psychopharmacology Research Unit at the University of Leeds in 1983 on 12 healthy women then aged between 27 and 43. It was testing sertraline, a type of anti-depressant which was later launched under the brand name Zoloft.
Half of the women on the trial were given the drug and the other half had a placebo.
However the planned two-week study had to be stopped on the fourth day because of severe side effects. The results were never published.
Now Prof Healy, director of the North Wales Department of Psychological Medicine of Cardiff University, wants to find the women involved.
He said he had seen a medical report from the trial in the archive of drug company Pfizer in New York.
“The side effects that seemed most clearly linked to sertraline were apprehension, insomnia, movement disorders, and tremors,” he said.
In 2003 drugs watchdog the Medicines and Regulatory Authority issued a warning about certain types of anti-depressants, including sertraline, saying they should not be prescribed to children and young people because of an increased risk of suicidal behaviour in these age groups.
Research psychologist Dr Joanna Le Noury, who is working with Prof Healy, said they now wanted to track down the Leeds participants.
Dr Le Noury said: “The idea is to get some interviews about what went on with the study and their experiences.
“It’s also to find out how things have panned out since. Because they had a strange reaction to the drug at the time, whether they have had similar drug reactions since.”
Contact:
jo.lenoury@btopenworld.com, call 01248 384452 or via:
http://davidhealy.org.
WASHINGTON – The nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade, but they remain in business with the federal government because they are often the sole suppliers of critical products, records show.
"We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."
In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said.
To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said his organization, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement. That could begin with cases being investigated now, he said.
TRENTON, N.J. — Eight drugmakers are being sued by a consumer advocacy group that alleges their programs offering coupons that lower the cost of copayments for brand-name medicines are illegal.
Community Catalyst alleges that the couponing programs violate federal bribery laws because they’re meant to conceal information about the payments from health insurance plans.
Such coupons generally reduce patient copayments for brand-name drugs to what they would pay for a generic drug. The group says that drives up health insurance premiums and can cause patients to reach benefit caps quicker.
The companies sued are Abbott Laboratories, Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Co., GlaxoSmithKline PLC, Merck & Co. Inc., Novartis AG and Pfizer Inc. They did not immediately respond to a request for comment.
Identical lawsuits, but with different defendants, were being filed Wednesday in federal courts in New York, Chicago, Philadelphia and Newark, N.J.
According to a study conducted by researchers from New Zealand, a number of
Pradaxa side effects are caused by prescribing errors. On March 1, 2012, a letter was published in the New England Journal of Medicine stating that 25% of the injuries caused by Pradaxa are due to prescribing errors.
Traditional blood thinning medications, such as warfarin, contain a reversing agent. This has led researchers to suggest that the adverse side effects of Pradaxa and other new blood thinners could be reduced if there was a reversing agent present.
The Food and Drug Administration issued a safety announcement in 2011 noting the importance of paying close attention to the proper method for storing Pradaxa and also included prescribing recommendations to healthcare professionals.
Pradaxa (dabigatran is prescribed to treat atrial fibrillation not caused by a heart valve problem and is included in a class of drugs referred to as “direct thrombin inhibitors.” Atrial fibrillation is a condition in which part of the heart does not beat properly. Because of this, blood cells form into clots, and travel throughout the body. A stroke may occur if the blood clots reach the brain and a pulmonary embolism may occur if the blood clots travel to the lungs.
The FDA approved Pradaxa in October of 2010. Shortly after the FDA approved Pradaxa for the treatment of atrial fibrillation a number of adverse side effects were reported. Side effects include internal bleeding, gastrointestinal bleeding, brain hemorrhaging, heart attack, and death.
Though no recall has been issued on Pradaxa, the FDA is currently in the process of investigating internal bleeding claims. So far, more than 500 bleeding cases were reported as a result of Pradaxa use, and only 176 bleeding cases were reported with use of warfarin.
No
Pradaxa lawsuit has been filed, however, attorneys are investigating and reviewing claims brought forth by victims who claim Pradaxa caused them to suffer adverse side effects.
A U.S. unit of
Takeda Pharmaceutical Co. (4502 failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, a whistle-blower claimed in a lawsuit.
The company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, former Takeda medical reviewer Helen Ge said in the complaint in federal court in
Boston. Takeda, like other drugmakers, is required to update the U.S.
Food and Drug Administration’s Adverse Event Reporting System.
“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
The case against Takeda Pharmaceuticals North America Inc., filed by Ge on the government’s behalf, became public after the U.S. Justice Department declined to join it on Feb. 22. Twenty- four U.S. states also declined to join Ge’s complaint, said one of her attorneys, Michael L. Baum.
Generic Copies
Takeda, based in
Osaka,
Japan, said Feb. 1 that annual profit will fall 48 percent to 130 billion yen ($1.6 billion in the year ending March 31. Sales of Actos, which generated 27 percent of revenue last fiscal year, declined 19 percent in the previous nine-month period and will slump more when it faces competition from generic copies in August, Takeda said.
Jocelyn Gerst, a spokeswoman for Takeda, didn’t immediately return a call or e-mail seeking comment on the complaint.
Ge’s complaint claims that on “multiple occasions,” Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, “her contract was summarily terminated,” according to the complaint.
Takeda wanted to make it appear that Actos was safer than GlaxoSmithKline Plc’s Avandia diabetes drug, according to the complaint.
‘Systematic Fraud’
Ge sued under the federal
False Claims Act and similar state statutes, and seeks to recover damages on behalf of governments. She would be entitled to between 15 and 30 percent of any recovery.
“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, according to the complaint.
In 2007, the FDA ordered Takeda and Glaxo to place its strongest warning on the labeling of their drugs about the risk of congestive heart failure, a condition that occurs when the heart doesn’t adequately pump blood.
Ge claimed that Takeda’s culture is “riddled with systematic fraud and deceit,” and that the company downplayed data suggesting a link between Actos and bladder cancer.
Baum, of Baum, Hedlund, Aristei & Goldman, said he is undeterred by the
Justice Department’s decision to not join the lawsuit after investigating. The U.S. declines to join four out of five cases filed under the False Claims Act. Companies settle the vast majority of cases when the U.S. intervenes.
“I believe that the documents we obtain in discovery will induce the government to come back in,” Baum said. “But whether they come back in or not, I believe the documents will show that the company violated the False Claims Act.”
One of Ge’s lawyers is
Michael Sullivan of The Ashcroft Group LLC. He is the former U.S. attorney in Boston.
The case is U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of
Massachusetts(Boston .
To contact the reporter on this story: David Voreacos in Newark at
dvoreacos@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at
mhytha@bloomberg.net.
On March 2, the United States Court of Appeals for the District of Columbia ordered an administrative
stay on the Immediate Suspension Order ("ISO" issued by the Drug Enforcement Administration ("DEA" against Cardinal Health, Inc.'s ("Cardinal" distribution facility in Lakeland, Florida. This stay postpones the ISO while the court considers Cardinal's emergency injunction
motion, which would halt the ISO pending Cardinal's separate appeal of the ISO. When granting the stay, the court stated that it had not yet considered the injunction motion on its merits. A decision on the merits will likely come soon, however, because the court ordered an
expedited briefing schedule, requiring the DEA's response to the motion by Friday, March 9, followed by Cardinal's reply on Monday, March 12.
The ISO, previously reported
here, suspended Cardinal's registration to distribute controlled substances (such as the pain medication oxycodone from its Lakeland facility to approximately 2,700 customers, including hospitals and pharmacies. Typically, the DEA revokes a registration after providing the registrant notice of the intent to revoke and a hearing. The DEA may issue an ISO without a hearing, however, when there is an "imminent danger to the public health or safety." Here, according to Cardinal, the DEA alleged imminent danger and issued the ISO without notice and a hearing.
Cardinal argues that there was no imminent danger to justify the DEA's action. The ISO did not allege that Cardinal distributed controlled substances to anyone that the DEA had not authorized to receive them. Instead, the ISO alleged that Cardinal sold high aggregate volumes of oxycodone to four pharmacies between 2008 and 2011. But by the time the ISO was issued, Cardinal had already suspended shipments to two of the pharmacies. Cardinal also noted that its shipments to the other two pharmacies had decreased by 80% prior to the ISO, which Cardinal then suspended after receiving the ISO. Consequently, Cardinal argues that its own remedial measures already negated any danger to the public and the ISO is unnecessary pending Cardinal's appeal.
Parents who filled prescriptions for fluoride pills at a Chatham, NJ CVS were shocked to learn that the they were erroneously given Tamoxifen, a drug commonly used to treat breast cancer in women. The retailer claims that 13 families have been affected. According to medical experts, children who took the medication are at little risk of developing health complications as a result.
A national shortage of injectable drugs has led the Alberta government to ask chemotherapy patients to buy their own anti-nausea medication from pharmacists starting Wednesday.
District Judge Richard Leon found that the attempt by the U.S. Food and Drug Administration (FDA to force cigarette makers to display graphic pictures of blackened lungs, rotten teeth and sickly patients on their products was unconstitutional. Carefully pointing out that the burden of proof lay on the side of the federal regulatory body, Leon stated that: “The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.” Leon also noted that the proposed warning labels, which aim to deter tobacco use, were exaggeratedly large. He also pointed out that the government already has a variety of more effective and targeted weapons for reducing smoking in its arsenal such as cigarette taxes and labels that contain factual medical information rather than macabre images. The Obama administration announced Monday that it would challenge the court’s decision, filing an appeal Monday with the U.S. Court of Appeals for the District of Columbia Circuit. According to legislation passed in 2009, the FDA is charged with the task of making sure that cigarette packaging is equipped with color warning labels in addition to the well-known written warnings from the Surgeon General. The label must cover 50 percent of both the front and back of the cigarette pack as well as 20 percent of advertisements in magazines. A handful of major tobacco companies challenged the law, which was scheduled to go into effect in September of this year. Tobacco giants R.J. Reynolds, Lorillard Inc., Liggett Group LLC and Commonwealth Brands have alleged that the legislation would essentially force them to advertise against the purchase of their own entirely legal products. --- On the Net:
Health Canada plans to fast-track new sources of certain medications following reports that shortages due to a production scaleback at Sandoz Canada's Quebec plant have led to cancellation of some elective surgeries, an Ottawa spokesman says.
—Michael Pollan, author of The Omnivore's Dilemma
—Anonymous
—Dolly Parton
—Chinese proverb
—Larry Elder
—La Rochefoucauld
—Thomas Edison
—Julia Child
—Karen Sessions
—Tony Robbins
—Alice May Brock
—Julia Child
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