NANTES, France — A French father-of-two is to take GlaxoSmithKline to court on Tuesday, alleging the British firm's drug to treat Parkinson's disease turned him into a gay sex and gambling addict.
The 51-year-old's lawyers say their client's behaviour changed radically after he was first administered the drug in 2003 for the illness, which causes tremors, slows movement and disrupts speech.
Didier Jambart, a married father-of-two who says he has attempted suicide three times, claims he became addicted to Internet gambling, losing the family's savings and stealing to feed his habit.
He also became a compulsive gay sex addict and began exposing himself on the Internet and cross-dressing. His risky sexual encounters led to him being raped, his lawyers said.
The behaviour stopped when he stopped taking the drugs in 2005 but by then he had been demoted in his defence ministry job and was suffering from psychological trauma resulting from his addictions, his lawyers said.
The plaintiff is seeking a total of 450,000 euros ($610,000) in damages from Glaxo, which he accuses of selling a "defective" drug, and from his neurologist for having failed to properly inform him about the drug.
The drug, Requip, has been known for years to have undesired side effects but a warning only appeared on its package insert in 2006, his lawyers said.
Glaxo said it did not wish to comment on the case.
Monday, January 31, 2011
AFP: Man claims Glaxo drug made him 'gay sex addict'
Delayed FDA Removal of Painkiller Propoxyphene From U.S. Market Has Cost More Than 1,000 U.S. Lives
Worst Pills, Best Pills Newsletter Article, January 2011
Note: Public Citizen petitioned the FDA in 1978 and 2006 to ban propoxyphene.
The November 2010 announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.
The FDA banned propoxyphene-containing products (DARVON, DARVOCET) because of dangers that have been known for years. In fact, the drug was banned in the U.K. almost six years ago and in the European Union almost 1.5 years ago.
Evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose (because a heart-toxic metabolite accumulates in the body), and is somewhat addictive. It has been linked to many thousands of U.S. deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including instances with interruption of electrical conduction in the heart.
In announcing its ban in 2005, the U.K. stated that the efficacy of propoxyphene “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “in relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” Thus the FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” rings dangerously hollow.
The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the U.K. and EU, but was for too long recklessly rejected by the FDA.
Since the January 2005 announcement of the U.K.’s phased, two-year withdrawal of this drug (followed by an immediate steep decline in use), approximately 120 million retail prescriptions have been filled in the U.S. for propoxyphene-containing drugs. These include DARVOCET, which contains propoxyphene and acetaminophen, DARVON and generic versions of the drug.
Due to FDA negligence, at least 1,000 to 2,000 (or more) people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced. The best forensic data — the kind relied upon for the U.K. and European bans, come from Florida, where routine drug testing is required as part of many autopsies. Deaths are categorized as being “caused” by a particular drug if the amount of the drug found in the body is above a certain level.
From 2005 through 2009, in Florida alone, 395 deaths were caused by propoxyphene. If data from 2007 are representative, about 78 percent of the Florida deaths caused by propoxyphene
were ruled accidental.After the U.K. ban, Public Citizen again petitioned the FDA in February 2006 to ban the drug. The petition did not even result in an FDA advisory committee hearing until we sued the agency in 2008 to force it to respond. The subsequent January 2009 FDA advisory committee hearing resulted in a 14-12 vote in favor of banning propoxyphene, despite some FDA efforts to sway the committee against voting for a ban. In July 2009, several weeks after the European Medicines Agency announced its ban, the FDA denied our petition to ban the drug.
The FDA’s excuse — that it needed to order a human study to find that “the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities” before deciding whether to ban propoxyphene — only emphasizes how out-of-step the agency is with the rest of the world, which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.
In a study on dogs published 31 years ago, researchers at Lilly, the discoverer of propoxyphene, stated that “cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose.” This study examined the same kind of functions measured in the human study being put forth by the FDA as a justification for belatedly banning propoxyphene.
We will ask for and support a congressional investigation into who in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before 2010, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.
Ulf Jonasson, Swedish Doctor of Public Health, on (dextro)propoxyphene
Drugs containing the substance (dextro) propoxyphene (DXP) are probably the worst drugs eve. Some of the brands are Darvon, Darvon-N, Darvocet, Distalgesic and Co-Proxamol. Darvon has been a popular painkiller since 1957 in US, and now it is time to ban the drug in US. The responsibilty for banning the drug in US is now in the hands of FDA. The European Union -- EU -- has decides to phase out the drug in the end of 2010.
The drugs containing DXP has caused 100 000´s death during the years -- and nobody has taken re-sponsibility for that. The pharmaceutical company Eli Lilly in US is to blame.
The European Union -- EU -- has decides to phase out the drug in the end of 2010.
Here's the transcript:
Ulf Jonasson, Doctor of Public Health, on YouTube:
Darvon, Darvocet, Co-Proxamol – the worst drugs ever.
http://www.youtube.com/results?search_query=jonasson+darvon&search=Search
Friends,
I would like to tell you a story, a very sad story about a painkiller that has been around in the Amer-ican society since 1957 – that is exactly 50 years. The name of the drug is DARVON or DARVON-N or DARVOCET. It is basically the same drug. In Europe the drug is called DISTALGESIC or CO-PROXAMOL. The working substance in the drug is PROPOXYPHENE or DEXTROPROPOXYPHENE as we call it in Europe.
We think drugs – containing PROPOXYPHENE – are the worst drugs ever, among prescribed drugs. No single drug in the history has caused so many fatal deaths as these drugs have done during the last 50 years.
How come I can sit here and say that? Are you supposed to believe me?
We – my wife Birgitta and myself – Ulf Jonasson, we are both doctors, PhD:s – have studied the dan-gers with PROPOXYPHENE since 1993, that is 13-14 years.
We have written and published eight scientific articles about PROPOXYPHENE. We have also written and defended two doctorial dissertations about the drug and its fatal consequences. And to get our alar-ming data outside the academic world, we also wrote a popular science version of our research that was published both in Swedish and English. The English name of the book is “Fatalities due to use or misuse of painkillers “
We think we have studied the consequences of using PROPOXYPHENE in a quite proper way, and therefore we will tell this sad story about a drug that probably have killed more people than any drug in the history.
One of the “Big Pharmas” in US, Eli Lilly “invented” PROPOXYPHENE in 1953 and it took some years before it came out on the market. There was a need for a painkiller – without side effects in the early 50s – and Lilly found PROPOXYPHENE. Have you heard this story before – a drug without side effects???
The drug was called DARVON – I am sure you have heard about it – and it became immediately very popular. It was not for the pain killing effects the drug became a financial success. Later on, studies showed that the pain killing effect was not better than aspirin or acetaminophen – like Tylenol. The users felt good, because DARVON is an opiate – close to methadone, morphine and heroin – and it influence your brain, you feel good. The drug influences your Central Nervous System.
As I told you before, we have studied PROPOXYPHENE since 1993. Our main result was that during the investigated years 1992 – 1999 – eight years – 200 persons in Sweden, were poisoned to death every year due to PROPOXYPHENE – poisoning. 200 persons died every year because they used a very popular painkiller and we thing this was very alarming. Sweden is a quite small country we have just about nine million inhabitants. In United States there are soon 300 million inhabitants and we knew, thanks to international statistics, that the American people used even more PROPOXYPHENE that the Swedish people did. Is it therefore possible for us to assume that there is more that 30 times as many fatal deaths in United States as in Sweden. Yes, we think so.
If we look at the consumption of PROPOXYPHENE in United States compared to Sweden, we find some very interesting figures. The average consumption of PROPOXYPHENE in Sweden – during the investigated years 1992-1999 – was 2 400 kg/year. In United States you consumed an average of 99 400 kg/year. It is more than 41 times as much in US than in Sweden. Is it possible that the numbers of fatal deaths in US are about 40 times more??? What do you think?
Here are some more figures. We know that consuming 2 400 kg/year in Sweden, caused 200 fatal death every year. You can say that it became one fatal death for consuming every 12 kilograms in Sweden. I think you understand and accept the metaphor. How many fatal death could that be if you consumed 99 400 kilogram a year in US??
The numbers are so high, you will not even think about them. And it gets even worse if you think back 50 years, consuming 80 – 90 – 100 000 kilograms a year in 50 years!!! In 2005 the consumption was 110 040 kg.
I will also mention some figures about the PROPOXYPHENE-situation in United Kingdom. They have also had huge problems with fatal poisonings due to PROPOXYPHENE. In the year 2004, some 1,5 million persons got 7,5 million prescriptions on their version of PROPOXYPHENE, namely CO-PROXA-MOL. These 7,5 million prescriptions became more than 900 000 000 CO-PROXAMOL pills. In the same year there were around 24 million prescriptions in United States, these 24 million prescriptions became almost 3 billion pills containing PROPOXYPHENE. This is 3 followed by nine zeros…
The medical product authorities in UK; the MHRA, decided January the 31st, 2005 that PROPOXY-PHENE – products would be phased out in the country till the end of the year. They did not succeed doing that. Why, there were so many problems to stop using the drug for the users, so many side effects, so much suffering to get rid of the drug.
MHRA then decided the drug to be out of the market in the end of the year 2006, but they did not succeed this time either. Today – the MHRA are saying that the drug definitive will be out of the market last December this year. Will they do that??? I do hope so.
Why do not the US authorities inform the American society about these harming drugs? We can put the answer in just two worlds, THE LAW. We have different laws in Sweden and in US. In Sweden we have one federal law for all four branches of the forensic medicine, which are medicine, chemistry, psychiatric and genetics.
In United States you have different laws in different states. In some states you have the old English system of CORONERS – and they are more investigators than medical doctors, you also have the MEDICAL EXAMINER SYSTEM, and they are medical doctors, but usually not specialists in forensic medicine.
And most important of all, in Sweden, the medical doctors take a blood test of all dead persons that come to the forensic medicine station. And these blood tests are all screened for every legal drug there is in Sweden, and that includes PROPOXYPHENE. Thanks to that routine we find our PROPOXYPHENE-cases, and unfortunately you do not find so many PROPOXYPHENE cases.
In Unites States, the decision to take a blood test is on the level of every one of the 3 200 counties in the country. And by many reasons the needed blood tests are mostly not taken. I think this is a big problem for your country, you loose lots of important information in many areas of medicine, missing the prevalence of PROPOXYPHE is just one.
I would like say a few more worlds about who are responsible for these tragedies, the many fatalities due to poisoning from PROPOXYPHENE. The manufacturers are – as I said earlier – ELI LILLY. The have earned billions of dollar during the last 47 or 48 years. Why do I not say the last 50 years?
The reason I say 47 or 48 years is that ELI LILLY sold the rights to their brands DARVON and the others – to some less known US pharmaceutical companies. And these companies were apparently not aware of our research. If they have known about this research, they would have been stupid to get into this crazy business of a drug that kills. LILLY has known about research since 1999 – at least in Sweden. We have printed proof for that.
LILLY is afraid of the consequences when the drug will be banned. They are afraid of how many people that will sue them because they have lost some dear ones, a father, a mother, a brother, a sister, a cousin, an aunt, an uncle or just a very close friend – that have died after that they have used a painkiller, fore example DARVON, DARVON-N or DARVOCET.
Do you remember VIOXX?? This drug was withdrawn from the market in 2004. The manufacturer, MERCK & Co, said that there was in increasing risk to get heart problem when using VIOXX. They talked about increasing risk,we talk about fatal deaths, thousands of fatal deaths – just in United States. Now MERCK & CO has to pay billions of dollars in damages.
You can say, that ELI LILLY, almost to the last minute – earned millions of dollars every year on their PROPOXYPHENE- drugs. Both in Sweden and in UK they did the same thing. They sold DISTALGESIC to another company in Sweden and UK. Kind of a surprise for this company – they bought a drug that was banned just after a short time.
Money are apparently more important than human lives for ELI LILLY, It is a simple as that.
I would like to finish this message by telling you how things could develop. After restrictions were implemented twice in Sweden, 2001 and 2005, thanks to our research – we now can say that 500 – 600 lives have been saved, just in Sweden. During 1992-99 some 200 persons were poisoned to death every year. The Medical Product Agency in Sweden recently informed that during the year 2005, 56 persons were poisoned to death. And we feel proud of what we have done.
We now feel a moral obligation to inform about the dangers with PROPOXYPHENE all over the world. And we know that, when the FDA will ban DARVON and the OTHER PROPOXYPHENE-brands, lots of lives- thousands and thousands – will be saved in Unites States. If the FDA doesn´t do that, the sad story continues.
We thank you for watching this video.
Good bye
"Darvon and Darvocet trials will be bigger than Vioxx," predicts Dr. Ulf Jonasson
Stockholm, Sweden: When Ulf Jonasson, Doctor of Public Health visited the US from Sweden in 2003 and again in 2004, he met with doctors at Public Citizen; doctors who had received studies by Dr. Jonasson and his partner, Birgitta Jonasson, PhD, and were calling for a ban on Darvon (Dextropropoxyphene), made by Eli Lilly. "We have researched Darvon side effects since 1993, and Public Citizen has worked hard to ban the drug before that," says Ulf Jonasson in a phone interview. "There could have been hundreds of thousands of deaths due to Darvon and Darvocet over the past 50 years."Jonasson and colleagues have published widely on Dextropropoxyphene (Darvon and Darvocet) deaths in Sweden. Following the publication of these reports and the involvement of politicians, the Swedish Medical Products Agency (MPA) held a seminar in spring 1999 focusing on the pharmacological and toxicological aspects of dextropropoxyphene (DXP). The following year, the MPA advised manufacturers to improve summaries of product characteristics, labeling and patient information leaflets to include more specific warnings about overdose and concomitant use of alcohol. Doctors were encouraged to prescribe smaller amounts, and not to prescribe to vulnerable patients.
Stricter prescribing regulations were introduced in June 2001, involving the use of a special prescription form and stringent monitoring of treatment efficacy. The effectiveness of these measures was assessed by Jonasson and Jonasson, who reported that sales of dextropropoxyphene products decreased by 66 percent between 1999 and early 2003, and the number of fatal dextropropoxyphene poisonings decreased by 62 percent between 2000 and early 2003.
Why didn't the FDA follow up on these studies? "Since 1999 we have informed the FDA about our research, and they know about our eight scientific articles about DXP and our two doctorial dissertations (2000 and 2001)," says Jonasson, "but Sweden is a small country and our legal system is different."
Jonasson is referring to the difference between the laws governing medical examiners and coroners. In Sweden, there is one legal system on the federal level, which dictates that every autopsy must be screened for legal drugs—including Darvon. In the US medical examiners and coroners are under county law—performing blood tests with an autopsy is rarely done because it is cost-prohibitive. "This is why Sweden has data that show Darvon is the worst drug ever, which is documented at the International Narcotic Control in Vienna," says Jonasson.
"We studied 1,600 people who died with Darvon in their blood. To put it into a nutshell, Darvon affects your heart muscles and you forget to breathe, so people die," Jonasson explains. "Our research was behind the decision in Sweden, the UK, and The European Union (EU) to stop the drug but it took a lot longer in the US."
By 1977, propoxyphene (Darvon, Darvon-N, Dolene) was the second most common drug involved in deaths from prescribed drugs in the US, and was estimated to cause between 1,000 and 2,000 deaths per year. On November 19, 2010, the FDA asked manufacturers of products containing dextropropoxyphene to withdraw them from sale. An estimated 10 million patients have used these products.
Why did the FDA wait until 2010 to have the drug withdrawn? "We believe the FDA is influenced very much by the drug companies, and we know that Eli Lilly, the Darvon manufacturer, has known about Darvon side effects for many years," says Jonasson.
"Attorneys across the US have contacted us—we are providing them with our data and they are very knowledgeable about this drug. I think the Darvon trials will become bigger than Vioxx because it has been going on for so long, but some people are just now realizing how catastrophic Darvon is."
(A $4.85 billion settlement fund paid claims from Merck, the maker of Vioxx, to the families of users of its painkiller who died of heart attacks or strokes.)
Oh the irony! BBC News - New health scare over Chinese Sunflower Seeds exhibition at the Tate Modern
The BBC has learned that the installation of 100 million porcelain "sunflower seeds" was made in China using paint containing lead.
Novartis ordered to pay $422.5 million fine for off-label marketing | Philadelphia Inquirer
Novartis Pharmaceuticals Corp. was officially ordered today to pay $422.5 million in civil and criminal fines for promoting an antiepileptic drug for non-approved uses, the U.S. Attorney's Office in Philadelphia announced.
The company had pleaded guilty Nov. 2 to marketing Trileptal, which had federal approval as an epilepsy drug, for additional uses that included bipolar disorder and neuropathic pain, the U.S. Attorney's Office said.
The U.S. Food and Drug Administration had not approved those latter uses.
Prosecutors said that Novartis made hundreds of millions of dollars from its off-label marketing.
The company was fined $185 million.
A separate civil settlement has Novartis paying $237.5 million over invalid claims submitted to government medical reimbursement programs for the use of Trileptal and five other drugs.
Novartis said last year that it had set aside money for the settlement, and that it had agreed to five years of additional federal monitoring, auditing, training, education, reporting, and disclosures.
In a statement late Friday afternoon, the company said: "The court imposed the previously agreed sentence pursuant to the resolution announced Sept 30, 2010. NPC is pleased to have this matter behind us, and will continue to work with the government and other organizations to improve health care for all Americans.
"We are committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products."
Novartis Pharmaceuticals, which is based in East Hanover, N.J., is the U.S. subsidiary of Novartis AG, which is based in Switzerland.
Three of the four whistle-blower cases were filed with the U.S. Attorney's Office in Philadelphia, which has prosecuted a number of major pharma cases. - Roslyn Rudolph
Pfizer ordered to pay $142.1M for Neurontin ads violating U.S. racketeering laws - Crain's New York Business
Pfizer Inc., the world’s largest drugmaker, was ordered to pay a total of $142.1 million in damages for violating U.S. racketeering laws in the marketing of its epilepsy drug Neurontin.
U.S. District Judge Patti Saris in Boston on Thursday upheld a jury’s finding that Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals deserved the award over the companies’ claims that Pfizer illegally promoted Neurontin for unapproved uses. Ms. Saris tripled the jury’s award of $47.3 million under a provision of the Racketeer Influenced and Corrupt Organizations Act of 1970.
“The damages awarded to the plaintiffs by the jury under RICO are trebled,” the judge said in her one-page order. Ms. Saris also denied Kaiser’s request for an estimated $76 million in interest on the award.
Kaiser officials alleged they were duped into believing that migraines and bipolar disorder could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.
Chris Loder, a Pfizer spokesman, said the company was pleased with Ms. Saris’ decision to deny Kaiser’s bid for pre-judgment interest on the award. “As we maintained all along, Pfizer has strong defenses in this case and intends to appeal,” he said.
Oakland, Calif.-based Kaiser, the first insurer to bring a Neurontin case against Pfizer to trial, claimed it was forced to pay $90 million more than it should have for the drug.
New York-based Pfizer currently faces more than 300 suits accusing it of illegally promoting Neurontin or hiding its health risks. Lawyers for ex-Neurontin users contend the drugmaker knew the medicine posed a suicide risk and failed to disclose it to patients and doctors.
The company also has settled at least two suits alleging the drug played a role in users’ suicides, paying almost $400,000 in one of the accords, people familiar with the deals said last year.
Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the drugmaker in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.
Ms. Saris, who is overseeing Neurontin cases from across the U.S. consolidated in federal court in Boston, recently dismissed more than 40 suits and a state-court judge in Missouri refused in August to all former Neurontin users to combine claims into a class-action case.
Glaxo's Prescription for Big Pharma Falls Far Short of Curing Industry Ills - Advertising Age - Rance Crain
Glaxo's Prescription for Big Pharma Falls Far Short of Curing Industry Ills
Company President's Actions Don't Appear to Match Up With Her Words
by Rance Crain
Published: January 31, 2011
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| Rance Crain | |
The guy, played by Jake Gyllenhaal, uses his way with the ladies to get into doctors' offices and replace Prozac antidepressant samples with his company's Zoloft. The sales reps are taught to sell the off-label capabilities of their drugs as a way to boost sales.
And when Viagra is introduced, he promises to give doctors all the samples they want if they prescribe other Pfizer drugs. If he hits his prescription numbers he's told he'll be promoted to the "promised land" of Chicago.
Deep down, though, Mr. Gyllenhaal's character has a good heart. While masquerading as an intern, he meets Maggie Murdock (Anne Hathaway) and eventually falls for her, learns everything he can about Parkinson's disease, commits himself to taking care of her, quits Pfizer and enrolls in medical school.
The movie is based on the book "Hard Sell: The Evolution of a Viagra Salesman" by James Reid, and as he explains in an interview, "everybody is trained to think and claim to be doing the right thing. That they're looking out for the doctors' and patients' best interest. But every drug rep has been trained that their drug is the best. So, when everybody's coming to the doctor saying their drug is the best, well, how could that be? Somebody's drug isn't the best."
Deirdre Connelly, president of GlaxoSmithKline's North American pharmaceutical unit, must have seen "Love and Other Drugs" and maybe even read the book. She acknowledged in an industry speech that "in some ways our industry has lost its way." But after reading her speech, I'm not so sure that she's doing much to get the industry and her company on the road to recovery.
Just like the movie depicted, she said the industry "relied on a competitive selling model based on sending in ever-greater numbers of sales representatives to call on a single doctor. The focus was on reach and frequency -- reach as many doctors as possible and provide them with our messages as often as possible." From now on, she said, Glaxo drug reps will not get bonuses based on sales targets but on criteria like overall performance of their business unit and assessment of their scientific and business knowledge. But who will make that assessment -- their doctor and hospital buddies?
Ms. Connelly pledged Glaxo won't blanket the airwaves with Levitra ads, but Glaxo hasn't run a TV commercial for its third-place erectile-dysfunction drug for a couple of years. And as pharmaceutical blog Pharmalot commented, "Of course, Levitra continues to trail Pfizer's Viagra, so saving money on an also-ran is a relatively easy move."
Ms. Connelly asserted that her sales reps are trained to emphasize the label restrictions of their drugs. But she also maintained that if doctors want to prescribe drugs for off-label symptoms, that's up to them. It's the doctor's job to determine "the appropriate drug for the appropriate patient in his medical opinion."
I also think Ms. Connelly is raising yet another strawman when she claimed some doctors participating in speaker programs for Glaxo are unhappy that they can't use their own slides, noting that the company wants to be sure that all info on its medicines -- both benefits and risks -- is presented in a "fair and balanced way." I can't imagine why this restriction should upset doctors getting paid to spread the word about the wonder of Glaxo drugs. After all, they're giving a canned pitch approved by Glaxo; why not use their slides, too? Then all they'd have to do is show up.
The reaction to Ms. Connelly's talk on Glaxo's bulletin board where the drug reps hang out: "So far the anonymous pollsters aren't loving it," reports NPR's health blog. And this from Pharmalot: "Like it or not Glaxo execs remain on the hot seat. The drugmaker has simply stepped in poop too many times in recent years. ... What went wrong? What didn't?"
Merrilee and I give "Love and Other Drugs" three stars. It was a saucy and frothy yet heart-warming tale. I was not, however, as captivated by Ms. Connelly's efforts to cure the ills of Big Pharma.
Dr. Reddy's Laboratories Gets U.S. Court OK To Sell Generic Allegra D-24 - FoxBusiness.com
Dr. Reddy's Laboratories Ltd. (500124.BY) said Monday a U.S. court has allowed the company to sell its generic version of Sanofi-Aventis's (SNY) anti-allergy drug, Allegra D-24.
The U.S. District Court of New Jersey on Jan. 28 lifted an earlier motion for preliminary injunction and cleared the sale of generic Allegra D-24, the Indian drug maker said in a statement.
Dr Reddy's had in March 2010 received the U.S. Food and Drug Administration's approval to make and sell generic Allegra D-24, but was restrained by the U.S. court from launching the product on the behest of Sanofi-Aventis and Albany Molecular Research.
US Lawyers advertise for more Glaxo Avandia claimants - Telegraph
Navid Malik, an analyst at Matrix, said he imagined that the provisions put in place by GSK this year deal with the bulk of the litigation risks going forward.
"While there has likely been an increase in legal advertising related to gathering plaintiffs in the US for Avandia – this typically happens in the US –
I am wondering whether the negative news since 2007 has already flushed out many of the plaintiffs," he said."It is possible that lawyers may gather more interest from new plaintiffs but I don't think the floodgates are about to open."
In 2009, there were more than 33,000 airings of Avandia-related adverts in America, valued at $6.5m (£4.1m). But last year, that rose to 52,000 airings at a value of $14.8m.
Glaxo Suit on Avandia Heart Attack Death Settled on Trial’s Eve - Businessweek
Jan. 31 (Bloomberg) -- GlaxoSmithKline Plc said it settled on the eve of trial a lawsuit alleging its Avandia diabetes drug caused a North Carolina man to die of a heart attack, avoiding a jury determination over risks associated with the medicine.
The U.K.’s biggest drugmaker resolved the suit by the family of James Burford, an Avandia user who died in 2006. The company declined to provide details of the accord’s terms. The resolution eliminates the risk Glaxo would face a large jury award, said Navid Malik, a drug-industry analyst at Matrix Corporate Capital in London.
Investors worried it “could lead to substantial punitive damages,” Malik said in a Jan. 25 interview. The company has already agreed to pay almost half a billion dollars to resolve claims it hid the drug’s health risks. “GSK needs to successfully settle as many of these cases as possible.”
The lawsuit, scheduled for trial this week in Philadelphia federal court, was the first of 2,000 heading to court alleging London-based Glaxo hid Avandia’s health risks. Regulators in Europe had the drug withdrawn from the market and U.S. sales were limited due to heart attack risks. Glaxo had also said it was setting aside money to address federal prosecutor probes of its marketing of at least nine drugs, including Avandia.
Mary Anne Rhyne, a U.S.-based spokeswoman for Glaxo, said in an e-mailed statement yesterday that the company settled the Burford case to avoid the risks and costs of litigation.
$3.5 Billion Charge
The pharmaceutical manufacturer announced Jan. 17 it’s taking a $3.5 billion charge to cover expenses linked to investigations and suits over Avandia. The reserve brings to $6.4 billion the amount the drugmaker has set aside in the last 12 months for legal costs tied to it.
The latest settlement resulted from the drugmaker’s move to resolve all Avandia cases brought by Joseph Zonies and Thomas Cartmel, two plaintiffs’ attorneys tapped by U.S. District Judge Cynthia Rufe in Philadelphia to lead a group steering the progress of more than 1,600 cases consolidated there. Zonies, of Denver, and Cartmel, of Kansas City, Missouri, didn’t return calls seeking comment.
Glaxo said in September it would stop promoting Avandia worldwide after regulators said the medicine would be withdrawn from Europe and sales would be limited in the U.S.
The company agreed last summer to pay about $460 million to resolve about 10,000 suits accusing it of hiding Avandia’s heart attack risks.
Facing 13,000 Lawsuits
At the time, the drugmaker was believed to be facing about 13,000 cases over the drug, Gbola Amusa, an analyst at UBS AG in London, said in an interview. Company officials said the accords resolved the majority of those suits.
Those settlements have generated another wave of lawsuits, Vance Andrus, a plaintiffs’ lawyer involved with the consolidation of cases in Philadelphia, said this month.
When they announced the $3.5 billion in charges, Glaxo officials said some of the funds would go toward covering the “substantial” number of new Avandia claims filed in the U.S.
The company said it also set aside money to cover fallout from an investigation by federal prosecutors into Glaxo’s marketing campaigns for nine drugs, including Avandia.
The company still faces at least 1,600 cases filed in Philadelphia and another 400 in state courts across the U.S., lawyers for Avandia users and the company said last week. Lawyers also have other cases that haven’t yet been filed under agreements with the drugmaker.
Electronic-Parts Salesman
Burford, an electrical-parts salesman, took Avandia for 15 months to treat diabetes before having a fatal heart attack in his North Carolina home, according to court filings. He was 49 at the time of his death.
Glaxo’s lawyers said diabetics like Burford are at an increased risk for heart attacks regardless of what drugs they take and that Burford’s lawyers couldn’t conclusively link Avandia to his heart woes.
Lawyers for Burford’s family alleged Glaxo refused to take Avandia off the market even though studies concluded it increased risks of heart attacks and strokes. They also claimed Glaxo officials withheld studies by regulators showing the increased risk tied to the drug.
The case is Deborah A. Burford v. SmithklineBeecham Corp., 07-CV-05360, U.S. District Court for the District of Pennsylvania (Philadelphia).
--With assistance from Sophia Pearson in Philadelphia and Albertina Torsoli in Paris. Editors: David E. Rovella, Jason Gale
To contact the reporter on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net.
Sunday, January 30, 2011
UK Government to launch £400 million drive to tackle mental health treatment - Telegraph
The move, designed to put mental health treatment on the same footing as physical illness or injury and to end the stigma attached to depression and other conditions, is to be unveiled in the next few days by Nick Clegg, the Deputy Prime Minister.
Ministers want the doctors to stop simply prescribing pills to patients with a range of conditions including eating disorders, self harm, addictions, attention disorders and post-natal depression – a practice which has led to claims the NHS is turning Britain into a "Prozac nation".
Instead they are targeting a massive take-up of "personalised" services, including one-to-one counselling and group therapy. The coalition believes at least one million people will take up these options over the next few years.
In addition, ministers want the NHS to "cure" up to one million sufferers by the next general election, expected in May 2015, by which time they hope that more than 70,000 people currently out of work with mental health problems will be back in employment, the Telegraph has learnt.
The Enema of Your Enemy is Your Friend - By Emily P. Walker - Slate Magazine
Fecal transplants could be a cheap and effective treatment for gastrointestinal disorders.
Includes DIY instructions!
Saturday, January 29, 2011
Texas jury orders Johnson & Johnson to pay $482 million in patent dispute over cardiac stents
Friday, January 28, 2011
Ed Silverman: Interview with a whistleblower
Donigian: When I started realizing they were using studies as a sales tool to get business. At first, I was kind of excited to get involved with clinical work. But when the patients weren’t meeting criteria for inclusion in the trials, I started raising questions. But they told me to enroll anybody and everybody or the physicians weren’t going to implant the devices. That’s when I started realizing we weren’t doing science.
Read the full interview here.
GSK halts almorexant development
Actelion said the decision followed a review of data from clinical trials of the drug, almorexant. There had already been some safety concerns over the treatment, so the news is not exactly a major surprise.
http://www.guardian.co.uk/business/marketforceslive/2011/jan/28/glaxo-slips-insomnia-setback?
Arena cuts 66 jobs
Sanofi Aventis - clinical trials ain't they a bitch!
Iniparib is also in phase III trials for patients with squamous non-small cell lung cancer, as well as in phase II trials for patients with breast, lung and other cancers.
Patients with triple-negative breast cancer lack the over-expression of three proteins: estrogen, progesterone receptors and HER2, giving rise to the term 'triple-negative breast cancer' or TNBC. This type of breast cancer continues to be difficult to treat due to poorer outcomes than other types.
More at http://www.realtimetraders.com/ArticleView.aspx?Id=1538391
DoJ go after Guidant and Boston Scientific
Thursday, January 27, 2011
FT Alphaville » AstraZeneca makes analyst cry
Here’s an early contender for the most amusing analyst research note of 2011.
It comes from London-based Druganalyst, which was one of the top 10 independent equity research firms in last year’s Extel survey according to the blurb on its website.
And the note concerns Thursday’s full year results from AstraZeneca, the drug company which doesn’t seem to have any drugs in its pipeline.
Enjoy!
I apologise for any spelling mistakes as it’s hard to write with the tears streaming down my face. No its not sadness that my SELL on Astra is getting squeezed by the open, it is laughter as I read that today’s miss would have been a heck of a lot worse had it not been for a visit to the UK pension fund and the making of a few adjustments. On top of this the company cuts its own R&D revenue expectations, and talks of a “favourable movement in managed market relative accruals” as a prime reason for the Crestor result…
They say sharks can identify fish dying and in difficulty from a distance of 3 miles. Apparently it is something about the way that they swim. Half decent sell-siders can do it with companies, it’s something about the excuses we hear from management as they attempt to shore up results and justify the future.
There’s going to be more buy-back. And just in case the umpteenth reiteration that the FDA doesn’t want more clinical trials on Brilinta hasn’t yet sunk in, did you know that the FDA doesn’t want more clinical trials on Brilinta? It just needs to be told why the drug doesn’t work in Americans.
There are 3 reasons why you may want to cream off your UK pension fund. You could have outperformed and so there was too much money in it. You could simply be doing a Robert Maxwell, though I am sure no-one at Astra would be so dastardly, or thirdly you could plan to sack so many employees early that they will never need pensions from you anyway. If there’s a 4th reason maybe you can tell me?
So with my eyes red and puffy with fresh tears of amusement, and with the great white sharks ever circling, my work here is done. I don’t think that I will need to revisit my Astra call ever again. I am so pleased about that!
We could not have put it better ourselves.
At pixel time shares in AZ were 56p higher at £31.50:
This entry was posted by Neil Hume on Thursday, January 27th, 2011 at 9:39 and is filed under Capital markets. Tagged with astrazeneca, Druganalyst, drugs, results. Edit this entry.
Wednesday, January 26, 2011
Report: 1/3 of warrior-unit soldiers addicted - UPI.com
WASHINGTON, Jan. 25 (UPI) -- A U.S. military report says up to 35 percent of the 10,000 soldiers in Warrior Transition Units are dependent or addicted to prescription painkillers.
An Army inspector general's report released Tuesday says 25 percent to 35 percent of the soldiers assigned to the special wound-care companies -- established after the 2007 Walter Reed Army Hospital scandal -- "are over-medicated, abuse prescriptions and have access to illegal drugs" as they wait sometimes more than one year for a medical discharge, USA Today reported.
Bad Project
Our submission for the Molecular and Human Genetics Retreat 2011 at Baylor College of Medicine. We decided to parody Lady Gaga's Bad Romance with a science twist. Many thanks to On the Rocks for the dance moves, and http://tinyurl.com/4lddjag for the mouse video.
FRANKFORT, Ky. Judge denies AstraZeneca motion for new trial
FRANKFORT, Ky. — A Franklin County judge has denied a pharmaceutical company's request for a new trial in a case in which it has been ordered to pay $20.5 million over inflated prescription drug prices.
A Franklin County Circuit Court jury in October 2009 delivered a $14.7 million verdict against drug company AstraZeneca for inflating drug prices for Medicaid reimbursements. Attorney General Jack Conway's office said Wednesday that civil penalties amounted to nearly $5.4 million, with another $396,000 in interest.
The state's Medicaid program calculates its drug reimbursement rates based on published average wholesale prices. Prosecutors claimed AstraZeneca inflated those published prices.
Conway said Judge Philip Shepherd denied AstraZeneca's motion for a new trial on Jan. 19.
Zef Eisenberg muscles his way into GSK | This is Money
It is every entrepreneur's dream: start a business, build it up into a million-pound company and sell it on to a billion-pound buyer for a handsome profit.And that is exactly what former body builder Zef Eisenberg has managed to do.
The founder of Maximuscle, the nation's largest supplier of sports nutritional products, recently sold his business to GlaxoSmithKline for £162m - the biggest-ever investment in the sports nutrition sector.
Eisenberg, 37, who was the brand's largest single shareholder outside of Darwin Private Equity, which bought Maximuscle in 2007 for £75m, said the approach from GSK came 'completely out of the blue'.
But then GSK, a dominant force in the world's healthcare and pharmaceutical arena, is keen to penetrate the sports and nutrition market. Hardly surprising considering it is valued at around £100m in the UK alone.
Prescribing Advice for GPs » NICE Guidance – January 2011
The National Institute of Health and Clinical Excellence has published new guidance for the month of January 2011. This month there is one clinical guideline and one technology appraisal that impact upon primary care.
The anxiety clinical guideline is a partial update (PDF). It provides evidence-based advice on the care and treatment of adults with generalised anxiety disorder or panic disorder with or without agoraphobia.
The technology appraisal reviews (PDF) the role of aripiprazole for schizophrenia in people aged 15 to 17 years. Aripiprazole is recommended when risperidone is contraindicated, poorly tolerated or provides inadequate control of symptoms.
Servier boss quits presidency of France's G5
Jacques Servier, founder of the drugmaker embroiled in the scandal concerning Mediator, the withdrawn diabetes treatment linked to the deaths of up to 2,000 people, is to step down as president of the French industry defence group G5.
G5, which consists of Sanofi-Aventis, Ipsen, Pierre Fabre, LFB and Servier, issued a statement saying that "due to exceptional circumstances affecting his laboratory", the 88-year-old head of the latter is stepping down to devote time to "the defence of his group at this particular time". It would appear there is a lot of defending to do, as Dr Servier is due in court on February 11 to face accusations in a lawsuit brought by alleged victims and their relatives that the company did not behave in a transparent way and made misleading claims about Mediator (benfluorex). The drug was withdrawn in France in November 2009 after reports that it had caused 500 deaths in the 30-odd years it had been on the market.
Allegra to be sold over the counter - The Denver Post
The Food and Drug Administration has approved French pharmaceutical giant Sanofi-Aventis to sell its Allegra allergy treatment without a prescription.
The Allegra family of products will be available in the U.S. over the counter as of March, Sanofi-Aventis said.
Tuesday, January 25, 2011
Stop Medicare Fraud - the widget
Health care fraud prevention and enforcement efforts recover record $4 billion; new Affordable Care Act tools will help fight fraud
U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and U.S. Associate Attorney General Thomas J. Perrelli today announced a new report showing that the government’s health care fraud prevention and enforcement efforts recovered more than $4 billion in taxpayer dollars in Fiscal Year (FY) 2010. This is the highest annual amount ever recovered from people who attempted to defraud seniors and taxpayers. In addition, HHS today announced new rules authorized by the Affordable Care Act that will help the department work proactively to prevent and fight fraud, waste and abuse in Medicare, Medicaid and the Children’s Health Insurance Program (CHIP).
These findings, released today, in the annual Health Care Fraud and Abuse Control Program (HCFAC) report, are a result of President Obama making the elimination of fraud, waste, and abuse a top priority in his administration. The success of this joint Department of Justice (DOJ) and HHS effort would not have been possible without the Health Care Fraud Prevention & Enforcement Action Team (HEAT), created in 2009 to prevent waste, fraud and abuse in the Medicare and Medicaid programs and to crack down on the fraud perpetrators who are abusing the system and costing American taxpayers billions of dollars. These efforts to reduce fraud will continue to improve with the new tools and resources provided by the Affordable Care Act, including the new rules announced today.
“President Obama has made it very clear that fraud and abuse of taxpayers’ dollars are unacceptable. And for too long, our fraud prevention efforts have focused on chasing after taxpayer dollars after they have already been paid out,” said Sebelius. “Thanks to the President’s leadership and the new tools provided by the Affordable Care Act, we can focus on stopping fraud before it happens.”
“Our aggressive pursuit of health care fraud has resulted in the largest recovery of taxpayer dollars in the history of the Justice Department,” said Perrelli. “These actions are in large part because of the great work being led by the Health Care Fraud Prevention and Enforcement Action Team. Through this initiative, we are working in partnership with government, law enforcement and industry leaders, and the public to protect taxpayer dollars, control health care costs, and ensure the strength and integrity of our most essential health care programs.”
Health Care Fraud and Abuse Control Program Report
More than $4 billion stolen from federal health care programs was recovered and returned to the Medicare Health Insurance Trust Fund, the Treasury, and others in FY 2010. This is an unprecedented achievement for the Health Care Fraud and Abuse Control Program (HCFAC), a joint effort of the two departments to coordinate federal, state, and local law enforcement activities to fight health care fraud and abuse.
The Affordable Care Act provides additional tools and resources to help fight fraud that will help boost these efforts, including an additional $350 million for HCFAC activities. The administration is already using tools authorized by the Affordable Care Act, including enhanced screenings and enrollment requirements, increased data sharing across government, expanded overpayment recovery efforts, and greater oversight of private insurance abuses.
HHS and DOJ have enhanced their coordination through HEAT and have expanded Medicare Fraud Strike Force teams since 2009. HHS and DOJ hosted a series of regional fraud prevention summits around the country, and sent letters to state attorneys general urging them to work with HHS and federal, state and local law enforcement officials to mount a substantial outreach campaign to educate seniors and other Medicare beneficiaries about how to prevent scams and fraud. During FY 2010, HEAT and the Medicare Fraud Strike Force expanded local partnerships and helped educate Medicare beneficiaries about how to protect themselves against fraud.
In FY 2010, the total number of cities with Strike Force prosecution teams was increased to seven, all of which have teams of investigators and prosecutors dedicated to fighting fraud. The Strike Force teams use advanced data analysis techniques to identify high-billing levels in health care fraud hot spots so that interagency teams can target emerging or migrating schemes along with chronic fraud by criminals masquerading as health care providers or suppliers. Strike Force enforcement accomplishments in all seven cities during FY 2010 include:
- 140 indictments involving charges filed against 284 defendants who collectively billed the Medicare program more than $590 million;
- 217 guilty pleas negotiated and 19 jury trials litigated, winning guilty verdicts against 23 defendants; and
- Imprisonment for 146 defendants sentenced during the fiscal year, averaging more than 40 months of incarceration.
Including Strike Force matters, federal prosecutors opened 1,116 criminal health care fraud investigations as of the end of FY 2010, and filed criminal charges in 488 cases involving 931 defendants. A total of 726 defendants were convicted for health care fraud-related crimes during the year.
In addition to these criminal enforcement successes, 2010 was a record year for recoveries obtained in civil health care matters brought under the False Claims Act—more than $2.5 billion, which is the largest in the history of the Department of Justice.
The HCFAC annual report can be found here, oig.hhs.gov/publications/hcfac.asp. For more information on the joint DOJ-HHS Strike Force activities, visit: http://www.StopMedicareFraud.gov/.
New Affordable Care Act Rules to Fight Fraud
Today, HHS also announced new rules authorized by the Affordable Care Act which will help stop health care fraud. The provisions of the Affordable Care Act implemented through this final rule include new provider screening and enforcement measures to help keep bad actors out of Medicare, Medicaid and CHIP. The final rule also contains important authority to suspend payments when a credible allegation of fraud is being investigated.
“Thanks to the new law, CMS now has additional resources to help detect fraud and stop criminals from getting into the system in the first place," CMS Administrator Donald Berwick, M.D. said. “The Affordable Care Act’s new authorities allow us to develop sophisticated, new systems of monitoring and oversight to not only help us crack down on fraudulent activity scamming these programs, but also help us to prevent the loss of taxpayer dollars across the board for millions of American health care consumers.”
Specifically, the final rule:
- Creates a rigorous screening process for providers and suppliers enrolling Medicare, Medicaid and CHIP to keep fraudulent providers out of those programs. Types of providers and suppliers that have been identified in the past as posing a higher risk of fraud, for example durable medical equipment suppliers, will be subject to a more thorough screening process.
- Requires new enrollment process for Medicaid and CHIP providers. Under the Affordable Care Act, States will have to screen providers who order and refer to Medicaid beneficiaries to determine if they have a history of defrauding government. Providers that have been kicked out of Medicare or another State’s Medicaid or CHIP will be barred from all Medicaid and CHIP programs.
- Temporarily stops enrollment of new providers and suppliers. Medicare and state agencies will be on the look out for trends that may indicate health care fraud – including using advanced predictive modeling software, such as that used to detect credit card fraud. If a trend is identified in a category of providers or geographic area, the program can temporarily stop enrollment as long as that will not impact access to care for patients.
- Temporarily stops payments to providers and suppliers in cases of suspected fraud. Under the new rules, if there has been a credible fraud allegation, payments can be suspended while an action or investigation is underway.
A copy of the regulation is on display today at the Federal Register and may be downloaded from the following link: www.ofr.gov/inspection.aspx. Several days after the regulation is published, the preceding link will be deactivated and the published version of the regulation will be available on the National Archives website at www.archives.gov/federal-register/news.html. CMS will continue to take public comments on limited areas of this final rule for 60 days.
More information can be found at www.HealthCare.gov, a web portal made available by the U.S. Department of Health and Human Services. A fact sheet on the new rules is available at www.HealthCare.gov/news/factsheets.
Medicare fraud: Tiny pharmacy turns whistle-blower - latimes.com
Reporting from Washington —Last December, a specialty pharmacy in Florida enjoyed its best month ever — posting a hefty $168.7 million in revenues.But it wasn't filling prescriptions that made Ven-A-Care of the Florida Keys Inc. such a success.
Tiny Ven-A-Care has developed a lucrative niche market: blowing the whistle on drug companies that overcharge Medicare and Medicaid — and collecting tens of millions of dollars in reward money.
Unlike most whistle-blowers who help the government with one case after they encounter wrongdoing, Ven-A-Care has filed suits alleging fraudulent conduct against dozens of drug companies supplying pharmacies and healthcare providers.
The company's whistle-blowing essentially works like this:
The company conducts research, comparing the prices it paid for drugs with the prices reported by drug makers to the government for reimbursement. Ven-A-Care files suit, on behalf of the government, when it spots large discrepancies between the two sets of prices.
The spreads can be dramatic.
A 2005 California suit alleged that a 1-gram vial of the antibiotic vancomycin was sold to providers for $6.29, but billed to Medi-Cal for $58.37, while 50-milligram tablets of the blood pressure medication atenolol were billed to pharmacies at $3.04 and to Medi-Cal at $70.30.
"I think Ven-A-Care has played a key role and possibly the predominant role in alerting state and federal governments about … fraud," said Nicholas Paul, a supervising deputy attorney general for the state of California, which filed the 2005 suit against 39 drug companies based on Ven-A-Care allegations. It has so far recovered about $95 million.
Joined frequently by the Justice Department or a state, the suits have yielded a string of handsome returns to Ven-A-Care and even more to state and federal governments.
Since 2000, the company has won settlements in at least 18 such suits. Three settlements announced last month brought the fees awarded the company and its attorneys since 2000 to more than $380 million.
State and federal governments, meanwhile, have collected about $2.2 billion from those cases. They have also changed reimbursement practices in an effort to make it harder for healthcare providers to reap windfall profits from drugs.
Both in recoveries for themselves and for taxpayers, Ven-A-Care's partners are apparently the most successful whistle-blowers in U.S. history.
"They're cleaning up a huge cesspool. Without their efforts, taxpayers would be gouged out of I don't know how much money," said L. Timothy Terry, an attorney and one-time Nevada state Medicaid fraud investigator who now represents whistle-blowers.
The Obama administration has made combating healthcare fraud a priority, encouraging whistle-blowers to come forward and opening a record number of new healthcare fraud cases. In 2010, federal prosecutors collected a record $2.5 billion via claims initiated by whistle-blowers, according to an announcement Monday by the Department of Health and Human Services.
Ven-A-Care is not without its detractors. Some complain that their awards are too large.
"We're spending tens of millions of dollars as a reward for information. The question is, 'Is it necessary?' " said Michael Loucks, formerly an influential healthcare fraud federal prosecutor in Boston who oversaw numerous multimillion-dollar, whistleblower-inspired settlements with drug companies.
Loucks, now a defense attorney, said whistle-blower payments should be capped at $2 million. "Somebody will still blow the whistle," he said.
Ven-A-Care attorney Jim Breen said large settlements were necessary to cover the expenses of mounting suits.
"If we're capped, we could never do what we've done — we couldn't return that amount of money to the government," he said. "In my average case, I probably have at least two major law firms, plus local counsel, opposing me. Cases like this require you to marshal millions of dollars."
Ven-A-Care's whistle-blower suits came after years of complaints the company made to lawmakers and healthcare bureaucrats about overpayments by Medicare and Medicaid connected to inflation of the average wholesale price, or AWP. This price was a benchmark used as the basis for reimbursement by the government insurance programs for the poor and elderly.
Ven-A-Care argues that drug companies have charged doctors, pharmacies and other providers a much lower price for drugs and allowed them to keep the spread between that price and a government reimbursement based on inflated AWPs, as a means of building the drug firms' market share.
"It destroys the price advantage of generic drugs," said Pat O'Connell, a whistle-blowers' attorney in Austin, Texas.
Ven-A-Care was created 23 years ago when a young Florida pharmacist named Luis Cobo and a nurse named T. Mark Jones went into the business of supplying intravenous drugs for AIDS and cancer patients.
Ven-A-Care's allies note that, until this month, no one had taken a case triggered by a Ven-A-Care complaint to trial. The trial of a state of Texas suit based on a Ven-A-Care filing, against Icelandic pharmaceutical firm Actavis, began Jan. 10 in Austin.
Cobo, Jones and two other Ven-A-Care partners involved in the suits did not return messages seeking comment.
Ven-A-Care's critics say federal participation is an unfair advantage because it can trigger a criminal investigation and an eventual conviction, which can lead to banishment from the Medicare and Medicaid programs.
Drug firms have also tried to derail Ven-A-Care suits by arguing that the company functions as a professional whistle-blower rather than a pharmacy and thus lacks the firsthand knowledge of fraud required by law.
Abbott Laboratories, for example, asked a judge to throw out what it called a "parasitic" Ven-A-Care case because "Ven-A-Care's officers candidly admit that they learned of Abbott's alleged 'fraud' by researching … catalogs and other publications that were equally available to thousands of other pharmacies."
But a judge declined to dismiss the case, and on Dec. 7, the Justice Department announced that Abbott had agreed to pay $126.5 million to settle Ven-A-Care complaints.
Attorney O'Connell acknowledged that whistle-blowing can have a mercenary aspect.
"It's a bounty hunting system. There's no reason to sugarcoat it," he said.
The firm's partners came to whistle-blowing reluctantly, associates say.
Disturbed by the price spreads, Ven-A-Care's office manager at the time, Zachary Bentley, once tried unsuccessfully to return a federal check that he thought was too big.
In one case, he found his firm was being charged only $49 per unit for a nutritional supplement when the government was reimbursing $428 per unit. Some years before, Bentley recalled, the Pentagon had been under fire for paying exorbitant prices for toilet seats on airplanes.
Hoping to awaken federal officials to the wasteful spending, Bentley bought a toilet seat and mailed it to Washington.