All care, no responsibility

Lexology has a great article today, written by and courtesy of lawyers from Arent Fox LLP. The article is, "Headlines that Matter for Companies and Executives in Regulated Industries".

Now, what is so great about that? It pinpoints some of the underpinnings of the outrageously expensive health care in the USA. Or, perhaps more to the point, the sabotage of them by "the system".

And, its a catalogue.

Item One: Florida Health Care Facility Owner Convicted in $1.3 Billion Fraud Scheme

After an eight-week trial, a federal jury in Florida convicted a health care facility owner for orchestrating one of the largest health care fraud schemes in US history. The case involved over $1.3 billion in fraudulent claims to Medicare and Medicaid for services that the jury found were not provided, were not medically necessary or were procured through the payment of kickbacks.

Helpfully, it links to the Department of Justice press release.

After an eight-week trial, Philip Esformes, 50, of Miami Beach, Florida, was convicted of one count of conspiracy to defraud the United States, two counts of receipt of kickbacks in connection with a federal health care program, four counts of payment of kickbacks in connection with a federal health care program, one count of conspiracy to commit money laundering, nine counts of money laundering, two counts of conspiracy to commit federal program bribery, and one count of obstruction of justice before U.S. District Judge Robert N. Scola Jr. of the Southern District of Florida.

Philip Esformes’ criminal scheme defrauded America’s health care system out of millions of dollars, that would have otherwise provided quality care to patients in need,” said U.S. Attorney Fajardo Orshan. This massive fraud scheme, perpetuated in nursing and assisted living facilities in our South Florida communities, compromised the integrity of our local health care system. Philip Esformes is a man driven by almost unbounded greed,” said Assistant Special Agent in Charge Denise M. Stemen of FBI Miami. “The illicit road Esformes took to satisfy his greediness led to over $800 million in fraudulent health care claims, the largest amount ever charged by the Department of Justice. Along that road, Esformes cycled patients through his facilities in poor condition where they received inadequate or unnecessary treatment, then improperly billed Medicare and Medicaid. Taking his despicable conduct further, he bribed doctors and regulators to advance his criminal conduct and even bribed a college official in exchange for gaining admission for his son to that university.

The FBI and its partners are constantly investigating health care fraudsters, big and small, who steal money from taxpayers at the expense of patients in need of quality medical care.

Say what!? Constantly investigating US health car fraudsters?

More juicy still is the link of this story to another outrage: the buying of seats at US colleges, which is a poke in the eye of the democratically minded merit testing system.

The evidence further showed that Esformes used his criminal proceeds to make a series of extravagant purchases, including luxury automobiles and a $360,000 watch. Esformes also used criminal proceeds to bribe the basketball coach at the University of Pennsylvania in exchange for his assistance in gaining admission for his son into the university.

Item Two: British Drug Maker Indivior Indicted For Opioid Marketing Fraud

On Tuesday, a federal grand jury indicted Indivior Inc., formerly known as Reckitt Benckiser Pharmaceuticals Inc., and Indivior PLC (collectively, Indivior) on charges that the companies orchestrated a “nationwide scheme” in the US to falsely market their under-the-tongue Suboxone Film. The criminal charges against the publicly traded British pharmaceutical giant include conspiracy, health care fraud, mail fraud and wire fraud. Federal prosecutors allege that Indivior exaggerated the benefits of its Suboxone Film, a new version of Indivior’s older opioid dependence pill, as a more child-proof and less addictive version of the drug’s tablet form. Notwithstanding the fact that the primary ingredient in both Suboxone Film and tablets is buprenorphine, a highly potent opioid.

The government further alleges that Indivior set up an internet and telephone “Here to Help” program to connect opioid-addicted patients to doctors that the companies “knew were prescribing Suboxone and/or other opioids in a careless and clinically unwarranted manner.” The 50-page, 28-count indictment seeks forfeiture of at least $3 billion.

And, another DOJ press release:

The deadly opioid epidemic continues to devastate communities and families across our nation,” said Principal Deputy Associate Attorney General Jesse Panuccio of the Department of Justice. “The Department of Justice intends to hold accountable those who are in position to know the harm opioid abuse inflicts, but instead choose to profit illegally from the pain of others. Manufacturers, distributors, pharmacies, and doctors should all be on notice that they must follow the law and act responsibly.” Assistant Attorney General Jody Hunt said, “Opioid addiction is a national epidemic. The indictment alleges that, rather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse.”

Touted as a resource for opioid-addicted patients, Indivior used the program in part to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in suspect circumstances. The indictment alleges that Indivior executives and employees knew from statistical and numerous firsthand reports that some doctors in the Here to Help referral system were issuing prescriptions in a careless and clinically unwarranted manner.

Indivior’s scheme, as asserted in the indictment, was highly successful, converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government. Until earlier this year, when Suboxone Film became subject to generic competition, Indivior retained a high portion of the opioid-addiction treatment market.

“Our indictment alleges a wide-ranging and truly shameful scheme to put profits over the health and well-being of patients trying to manage substance use disorder and opioid dependence,” said Attorney General Mark R. Herring. “It’s incredibly frustrating that while we have been working to remove the stigma around medication-assisted treatment and make it more widely available, Indivior was allegedly conspiring to exploit patients, taxpayers, and the expansion of MAT.

This investigation revealed that Indivior tried to mislead FDA and game the system by attempting to bar competition for Suboxone from the market,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs.

Item Three: Oklahoma Doctors Settle Allegations of Pain Cream Prescription Kickbacks, and yet another DOJ press release:

Two more Tulsa doctors have entered into settlement agreements with the U.S. Attorney’s Office for allegedly accepting illegal kickback payments from OK Compounding, LLC, announced U.S. Attorney Trent Shores. Lam Nguyen, 47, a licensed doctor of osteopathic medicine, agreed to pay the government $124,139.98 for allegedly accepting illegal kickback payments from OK Compounding. In a separate settlement, Hugo Salguero, 44, a licensed medical doctor specializing in pain medicine, agreed to pay the government $228,301.76 for allegedly accepting illegal kickback payments from OK Compounding. Since January 2019, seven medical professionals have settled for allegedly receiving kickback payments from the company.

Beginning in 2013, Dr. Nguyen and Dr. Salguero prescribed pain creams for their patients, facilitating the sale and distribution of the creams. As compensation for their services, OK Compounding paid the doctors based upon an hourly rate. However, the payments the two physicians received from the company were, in actuality, kickbacks. Because some of the patients were insured by Medicare, Tricare, and the Veterans Health Administration, the kickbacks were in violation of the False Claims Act.

"These settlements highlight the Defense Criminal Investigative Service (DCIS) and its law enforcement partners' commitment to aggressively investigate health care providers who defraud the Department of Defense (DoD) health care program known as TRICARE, to preserve American taxpayer dollars intended to care for our warfighters, their family members and military retirees," said DCIS Special Agent in Charge Michael C. Mentavlos.

Item Four: ‘Closed Door’ Michigan Pharmacy Owner and Pharmacist Charged with Health care Fraud, and yet another press release:

According to the indictment, between January 2010 and January 2018, Wansa Makki owned and oversaw the operations of two local pharmacies, LifeCare Pharmacy in Livonia and LifeCare of Michigan in Farmington Hills. Mohamad Makki was the pharmacist-in-charge at both pharmacies. Both pharmacies were “closed door” pharmacies, meaning that they were not open to the public and only filled prescriptions for individuals associated with various care facilities. The indictment alleges that during the course of the conspiracy, Wansa Makki and Mohamad Makki billed Medicare, Medicaid and Blue Cross Blue Shield of Michigan for approximately $9.2 million dollars for medications that were never dispensed. The fraud scheme was detected by Medicare, in part, because of a huge deficit between each pharmacy’s recorded inventories and the claims that each submitted for insurance reimbursement. As part of the scheme to defraud, the defendants billed insurance companies for allegedly submitting claims for delivering over 500 medications to people who had died prior to the claimed date of delivery.

According to the indictment and related criminal complaints, proceeds of the fraud scheme were laundered by overpaying consulting and delivery companies operated by close relatives of Wansa and Mohamad Makki. For instance, according to the complaints, Hossam Tanana was previously convicted for diverting controlled substances such as oxycodone, hydrocodone (Vicodin) and alprazolam (Xanax) while being licensed as a pharmacist. Two days after being released from federal custody in April of 2012, Tanana incorporated a pharmacy consulting company. Between the date of incorporation and December of 2013, Tanana’s consulting company received over $400,000 from the LifeCare Pharmacy. LifeCare Pharmacy also paid over one million dollars to a delivery service opened by Wansa Makki’s brother, Mahmoud Makki, in a 14-month period beginning in December of 2013.

An indictment is only a charge and is not evidence of guilt. Each defendant is entitled to a fair trial in which it will be the government's burden to prove guilt beyond a reasonable doubt.

Doctors, heal thy selves.

Of course, there's also Big Pharma.... 

Drug Distributor And Former Execs Face First Criminal Charges In Opioid Crisis

Rochester Drug Co-Operative Inc., one of the nation's 10 largest pharmaceutical distributors in the U.S., its former CEO Laurence Doud III and former chief of compliance William Pietruszewski were charged with conspiracy to distribute controlled narcotics — oxycodone and fentanyl — for non-medical reasons and conspiracy to defraud the United States. RDC and Pietruszewski are also charged with willfully failing to file suspicious order reports to the Drug Enforcement Administration. Both executives face maximum sentences of life in prison and a mandatory minimum prison term of 10 years on the drug trafficking charges. They face a maximum five years in prison on the charge of defrauding the government.

The Rochester, N.Y.,-based company is a middleman between drug manufacturers and local independent pharmacies. It supplied more than 1,300 pharmacies and earned $1 billion per year during the relevant time period."This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country," U.S. Attorney for the Southern District of New York Geoffrey Berman said in a statement. "Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms."

According to the U.S. Attorney's statement:

"From 2012 to 2016, RDC's sales of oxycodone tablets grew from 4.7 million to 42.2 million – an increase of approximately 800 percent – and during the same period RDC's fentanyl sales grew from approximately 63,000 dosages in 2012 to over 1.3 million in 2016 – an increase of approximately 2,000 percent. During that same time period, Doud's compensation increased by over 125 percent, growing to over $1.5 million in 2016."

The company has agreed to pay a $20 million fine and submitted to three years of independent compliance monitoring. "We made mistakes," company spokesman Jeff Eller said in a statement.

Science (fiction?)

Novel Way Discovered to Decode and Read DNA: Scientists

According to a new report, scientists have discovered a new way to read and decode DNA. Scientists are suspecting this research could forever change the ways on how doctors uncover, diagnose and treat various diseases.

Researchers said the main aim of this research is to understand the process of storage of biological functions in the human genome.

The research, published in the journal Science, states how genomes use genetic code to write information about proteins and that too in two separate languages. Researchers believe that the second language lies below the first and instruct the cell to control the genes.

Dr. John Stamatoyannopoulosm, lead researcher, said: "For over 40 years we have assumed that DNA changes affecting the genetic code solely impact how proteins are made".

Researchers said this novel research has thrown light on the fact that the DNA is an incredibly powerful information storage device, which has been fully exploited by nature.

Don't Be Duped By 'Duon' DNA Hype

I can only hope that Stamatoyannopoulos didn’t really say that. The authors report that changes in a single DNA sequence can influence both the protein it encodes and the place where other proteins bind to initiate copying. So evolutionarily, a single change could influence two endpoints–copying the sequence and what gets made using the same sequence. That’s cool, but not actually new.

With today’s headlines hyping “Second Code Uncovered Inside the DNA,” you might think that scientists are running around in circles in their labs, tearing out their hair, and screaming. But the real reaction of scientists to these headlines is more along the lines of this Twitter conversation among several scientific experts and science writers. They have good reason to be snarky.

The hype began with the way hype often begins: an institutional news release offering us the holy grail/huge breakthrough/game-changing finding of the day. This kind of exaggeration is the big reason any science consumer should look well beyond the news release in considering new findings. A news release is a marketing tool. You’re reading an advertisement when you read a news release; it’s also scientifically garbled and open to all kinds of misinterpretation, as the comments at the link to the release make clear.

Scientists have not assumed that the genetic code “was used exclusively to write information about proteins,” or even ever assumed that it “writes information about proteins,” whatever that means. A quick primer: Proteins are molecules that do the work of an organism, and that includes the work of copying DNA for protein production and cell division. Even nonmajors biology textbooks cover the fact that the DNA sequence both contains code for proteins and serves a regulatory purpose, making it possible to copy that code into a form the cell can read, recipe-like, to build the proper protein.

(edited in article) I’d be stunned if UW scientists were genuinely “stunned” to discover this dual use of DNA sequences to “write” “two separate languages” because what they really describe is the use of a single language, the language of nucleotides, for two known purposes. They themselves noted that “the potential for some coding exons to accommodate transcriptional enhancers or splicing signals has long been recognized.”

The release also contains gems such as “The genetic code uses a 64-letter alphabet called codons.” This sentence makes me sad. Codons consist of three nucleotides–which we designate with the letters A, C, G, and T/U–and there are 64 of these triplets, 61 of which serve as molecular code words for 20 amino acids (here is a DNA nucleotide codon table, too; these are the codons the authors address). Some amino acids get more than one word to designate them. The cell “reads” these code words and uses the amino acids they designate to build proteins.

The other problem is the ubiquitous use of the phrase “second code” in so many of the headlines related to this story when the authors themselves state: “ Although nearly all codon biases parallel TF recognition preferences genome-wide…” with the arginine codon as an exception. That’s not a “second code,” even though the news release describes it that way. It’s a different (but already recognized) use of an existing code, now identified as occurring at a greater than previously recognized frequency in areas that use the same code for proteins.

So what was the real import of the study that warranted its publication in Science, a “glamor” science publication? The authors (whose paper I enjoyed) seem to have found that the genome contains more of these dual-use triplet DNA sequences than previously thought, which might make them more relevant when examining some aspects of evolution (see “Single change could influence two endpoints”). And, it seems, the authors wanted the opportunity to, um, codify their own term for these dual-use sequences: duons. I wonder if they realized that the name had already been taken?

Ah, science. Guambat wonders why Mrs Guambat spends so much time watching all the "Housewives of..." shows, when they hardly know the meaning of the term "bitchy". Academic "science" (so often commercial "innovation") could open a whole new realm of reality show in way it never imagined.

Drug crimes

GlaxoSmithKline to pay $3 billion for health fraud

Of the penalties, $1 billion covers criminal fines and forfeitures and $2 billion is for civil settlements with the federal government and the state governments of Massachusetts and Colorado.

GlaxoSmithKline to pay $3bn in US drug fraud scandal

The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).

GSK, one of the world's largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.

The illegal practice is known as off-label marketing.

The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.

In addition, GSK has been found guilty of paying kickbacks to doctors.

"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.

GSK said in a statement it would pay the fines through existing cash resources.

Yep, just a cost of doing business the Big Pharma way.

Cinco de Mayem

It's a gringo thing, that Cinco de Mayo stuff. Mainly celebrated by Norte Americanos who need an excuse to drink and eat beans. As if.

History.com explains its, well, history, and we can only hope this is not a deja vue all over again.

In 1861 the liberal Mexican Benito Juárez (1806-1872) became president of a country in financial ruin, and he was forced to default on his debts to European governments. In response, France, Britain and Spain sent naval forces to Veracruz to demand reimbursement. Britain and Spain negotiated with Mexico and withdrew, but France, ruled by Napoleon III (1808-1873), decided to use the opportunity to carve a dependent empire out of Mexican territory. Late in 1861, a well-armed French fleet stormed Veracruz, landing a large French force and driving President Juárez and his government into retreat.

Certain that success would come swiftly, 6,000 French troops under General Charles Latrille de Lorencez (1814-1892) set out to attack Puebla de Los Angeles, a small town in east-central Mexico. From his new headquarters in the north, Juárez rounded up a rag-tag force of 2,000 loyal men—many of them either indigenous Mexicans or of mixed ancestry—and sent them to Puebla. Led by Texas-born General Ignacio Zaragoza (1829-1862), the vastly outnumbered and poorly supplied Mexicans fortified the town and prepared for the French assault. On May 5, 1862, Lorencez drew his army, well provisioned and supported by heavy artillery, before the city of Puebla and led an assault from the north. The battle lasted from daybreak to early evening, and when the French finally retreated they had lost nearly 500 soldiers. Fewer than 100 Mexicans had been killed in the clash.

Although not a major strategic win in the overall war against the French, Zaragoza's success at Puebla represented a great symbolic victory for the Mexican government and bolstered the resistance movement. Six years later—thanks in part to military support and political pressure from the United States, which was finally in a position to aid its besieged neighbor after the end of the Civil War—France withdrew. The same year, Austrian Archduke Ferdinand Maximilian, who had been installed as emperor of Mexico by Napoleon in 1864, was captured and executed by Juárez's forces.

Read more at the link above.

Mexonline.com adds local flavour.

It is primarily a regional holiday celebrated in the Mexican state capital city of Puebla and throughout the state of Puebla, with some limited recognition in other parts of Mexico, and especially in U.S. cities with a significant Mexican population. It is not, as many people think, Mexico's Independence Day, which is actually September 16.

Celebrating Cinco de Mayo has become increasingly popular along the U.S.-Mexico border and in parts of the U.S. that have a high population of people with a Mexican heritage. In these areas the holiday is a celebration of Mexican culture, of food, music, beverage and customs unique to Mexico.

Commercial interests in the United States and Mexico have also had a hand in promoting the holiday, with products and services focused on Mexican food, beverages and festivities, with music playing a more visible role as well. Several cities throughout the U.S. hold parades and concerts during the week following up to May 5th, so that Cinco de Mayo has become a bigger holiday north of the border than it is to the south, and being adopted into the holiday calendar of more and more people every year.

What's to celebrate?


23 dead, 9 found hanging from bridge, in Nuevo Laredo

The bodies of nine people were found hanging from a bridge just south of Laredo, Texas in the Mexican town of Nuevo Laredo early Friday morning. Five men and four women were among those dead.

Bodies of 23 found dumped near U.S. border in Mexico drug war

found hanging from a bridge or dismembered in ice boxes and garbage bags

Police could not confirm who was responsible for the murders but a message seen with the bodies indicated it may have been an attack by the Zetas cartel against the rival Gulf cartel. The Zeta cartel was founded by deserters from the Mexican special forces who became Gulf cartel enforcers and later split from their employers.

The two gangs are now fighting for control of local drug trafficking routes.

In Nuevo Laredo, 23 corpses found on grisly day in Mexican drug-cartel war

A Web site devoted to news about narco-violence published photographs of the nine victims — five men and four women — swinging from the bridge, the corpses bloody and bearing marks of torture. Some had their pants pulled down to their ankles.

There was a banner hung beside the bodies on the bridge, and its profanity-laden message boasted that “in this way I am finishing you all off.” It also said that one victim “cried like a woman giving birth.”

Feel like celebrating now? With terrorists right on our doorstep?

Premature ejection costs Medicaid big time after Big Pharma gets involved

Guambat's second grandchild was ejected yesterday on time, if only a few days earlier than the St Paddy's Day ETA. He is healthy and whole.

Some mothers, though, have very serious problems keeping baby in until safe to eject. The serious medical problem was not a serious financial problem until a Big Pharma player got official approval for a preemie prescription. Before, the cost of medication was $20/shot. Now it is $1,500/shot. And the shot doesn't go to the bottom of the baby, it goes to the bottom line of Big Pharma, and the top line of Medicaid and other insurance costs.

Price of drug to prevent preemies jumps from $20 to $1,500 after FDA approval

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer the progesterone shots to high-risk women. But because there has not been a commercial product available, women have obtained the drug from so-called compounding pharmacies, which make it to order. The pharmacies have typically charged about $10 to $20 per shot for the drug, which is given weekly.

Last month, however, the FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose.

Meanwhile, women are unlikely to be able to continue to get the drug at compounding pharmacies. K-V sent letters to the pharmacies warning them of potential FDA action if they keep distributing the drug.

The burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.

Big Pharma-care

Drug Companies Hire Troubled Doctors As Experts

Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies' drugs.

But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

We're talking about big money. Just from these seven companies, they've paid out more than $257 million in the past 18 months, and remember not all of these companies have even disclosed their payments for that whole period of time, so it's likely going to be substantially more, just for these seven companies.

What do they get for it? They wouldn't be spending this kind of money if they weren't getting returns from the perspective of increasing their brand in the market, letting doctors know about it, encouraging them to prescribe it. They say that doctors' success at increasing prescriptions is not a means in which they're measured, but some of the lawsuits against the industry have said that prescriptions and return on investment absolutely play a role.

Over 17,000 US Doctors Paid By Drug Companies To Spread Their Message

Giving money to doctors in this way is not against the law. In fact, ProPublica admits that a strong relationship between doctors and companies that make medications can be good, and lead to innovation and better therapies.

However, according to studies, giving doctors payments and even small gifts can undermine their professional approach. A separate Consumer Reports poll revealed that 74% of the American public think doctors should not receive money from pharmaceutical companies which ask them to encourage their peers to prescribe certain drugs.

The authors of the report warn that the 17,000 figure could be significantly higher. The current total represents data on just 7 drug companies. Over 70 companies are keeping their cards close to their chest and not revealing their data.

There is much, much more to read and learn about in these two articles.

Big Pharma still hyping hypocondria

Guambat mentioned this issue over two years ago in Restless leg-up syndrome.

But the latest hype also hypes newspapers, as the following samples illustrate.

Sex always sells.

Drugs companies 'hype-up female libido problems'

Writing in the British Medical Journal (BMJ), Ray Moynihan said pharmaceutical firms were guilty of wrongly giving the impression that "hypoactive sexual desire disorder" was widespread.

Mr Moynihan, a broadcaster and lecturer at Newcastle University in Australia, said companies funded surveys designed to suggest the problem affected large numbers of women, and also took a lead in "educating" professionals and the public about it.

For example, he said a Pfizer-funded course for US doctors claimed that up to 63 per cent of women had sexual dysfunction and it went on to suggest taking testosterone and Viagra as a treatment. But he said studies later showed that using Viagra for such a purpose had no effect.

He warned: "The drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacturer."

Drugs giants cashing in by 'inventing' low libido label in women

Female sexual dysfunction 'excuse by drug firms to sell pills'

Is Female Sexual Dysfunction the Next Big Disease?

"La industria quiere retratar a los ciudadanos como enfermos"

Дигнозы придумывают, чтобы было что лечить?

Kadında 'Cinsel Bozukluk' İlaç Firması Uydurması mı?

Ženské problémy v sexu? Výmysl farmaceutických firem

Opfandt sygdom for at sælge Viagra

La Voce d'Italia: Viagra rosa, la menzogna farmaceutica

Yep. In any language.

Patently wealthy

"Over the next two years, the heirs of Fritz Hoffman, founders of Roche, one of the world's most powerful pharmaceutical companies, and who already rank as among the world's richest families, could see their combined £10 billion fortune reach giddy heights. Twenty members of the founding family control Roche, which industry analysts estimate will benefit from the Tamiflu drug thought to relieve the symptoms of avian flu, with extra profits of £500 million this year and £1bn next. And since the family owns about 10 per cent of shares and crucially 50.01 per cent of voting rights, they will ensure that no outside interests seize their company and enjoy the profits - though many would like to.

"As avian flu spreads from south east Asia into Europe, sparking fears of a worldwide epidemic that medical experts say could claim 50 million lives, Roche, famous as the company behind the Valium tranquilliser, appears poised to clean up. The Basel-based company is already the fastest growing drugs firm in the world with a share performance to match. Investor returns have increased 50 per cent in a year. Last week its share price reached record highs after it said third-quarter profits rose by 20 per cent to £3.9bn.

"And that growth is primarily due to a drug it did not even invent. It was US biotech firm Gilead that developed Tamiflu. But nine years ago, Gilead signed a development and licensing agreement with Roche. It is currently the subject of legal action which will be resolved in a year. Gilead claims Roche has been negligent in its manufacture of Tamiflu which has led, Gilead says, to a series of product recalls. Gilead also says Roche has failed to market the product well, which has reduced the potential revenue the drug could have made. Roche categorically refutes the allegations.

"But as legal action rumbles, Roche faces other possibly more serious threats. The firm is under unrelenting pressure to increase production of Tamiflu. In the US, senator Charles Schumer has threatened legislation compulsory to license Tamiflu unless Roche allowed generic producers to boost the number of pills in circulation. The senior Democratic senator for New York accused Roche of 'putting profits ahead of world safety'. He has threatened with other Republicans to introduce legislation to force Roche to relax its stranglehold on the drug.

"Pressure appears to have paid off. Last Thursday, after a month of holding its position, Roche said it would talk to four generic drug manufacturers about increasing production. But health campaigners say this is no guarantee that Roche will act. And if it does, it will delay matters as long as possible so it gets the most revenue possible before low-cost manufacturers get in on the act.

"Michael Bailey, of campaigning group Oxfam says: 'This situation is absurd. A government will have to make a move because Roche seemingly can't deliver. It's a classic case of international intellectual property law not working. It seems Roche is holding on as long as possible before allowing generic companies the right to produce so it can make as much cash as possible.'

"Although its expertise is not disputed, the firm has been no stranger to controversy. In the Seventies, Stanley Adams, a Roche employee, handed over documents to the European Economic Community as it was then, detailing how the company kept the price of vitamins high with the explicit collusion of its supposed rivals. But an EEC bungle identified Adams. Roche decided to prosecute and he was imprisoned under tough Swiss commercial secrecy laws. His wife then committed suicide.

"Twenty years later, Roche was at it again - marshalling a price-fixing cartel in exactly the same product. It was fined more than $500m by US and EU competition regulators." http://observer.guardian.co.uk/business/story/0,6903,1598469,00.html

When you recall that patents are government granted and protected monopolies, I have long had the notion that a patent should be revoked if the holder abused it, such as failing to exploit the patent by withholding production, entering into price-fixing cartels or other anti-trust behaviour. Along with the monopoly should come the obligation to act responsibility with the patented product. Don't fine them, if there's an abuse of patent, just revoke the patent. Should go for copyright, too, Mr Gates.