A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States. FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.
The FDA has been criticized for failing to take precautions that might have averted the epidemic of addiction to prescription drugs including Oxycontin and other opioids.
OTHER RECENT RELATED NEWS:
- Big Bucks, Big Pharma: Marketing Disease and Pushing Drugs (Documentary)
- Obamacare: Welcome to the New Face of Big Pharma (Ad Week)
- Even Huge $11 Billion Fines Don’t Stop Big Pharma (Natural Society)
- DSM-5 Criticized for Financial Conflicts of Interest (ABC)
- The Psychiatric Drug Crisis (New Yorker)
- Obama Administration, Congress Intensify Opposition To Global Generic Drug Industry (Huffington Post)
- Dr. Ben Goldacre’s Big Pharma News Section (Bad Science)
- Industry Fights Maine’s Prescription Drug Law (Courthouse News)
- Doctors ‘offered bribes for referrals to private firms’ (Telegraph)
- Novartis Accused of Paying China Doctors Kickbacks, Herald Says (Bloomberg)
- Deaths from painkiller overdose surge to record (Reuters)
- The FDA Did Not Do Enough to Restrict Antibiotics Use in Animals (The Atlantic)
- For Heart Patients, Exercise as Good as Drugs (Newser)
- Pro Publica Report: Tylenol can lead to liver failure, death (RT)
- Pets and Prozac (My Fox NY)
- Doc financial interest may influence MRI referrals (Reuters)
The U.S. Centers for Disease Control and Prevention has just published a first-of-its-kind assessment of the threat the country faces from antibiotic-resistant organisms, ranking them by the number of illnesses and deaths they cause each year and outlining urgent steps that need to be taken to roll back the trend.
The agency’s overall — and, it stressed, conservative — assessment of the problem:
- Each year, in the U.S., 2,049,442 illnesses caused by bacteria and fungi that are resistant to at least some classes of antibiotics;
- Each year, out of those illnesses, 23,000 deaths;
- Because of those illnesses and deaths, $20 billion each year in additional healthcare spending;
- And beyond the direct healthcare costs, an additional $35 billion lost to society in foregone productivity.
“If we are not careful, we will soon be in a post-antibiotic era,” Dr. Tom Frieden, the CDC’s director, said in a media briefing. “And for some patients and for some microbes, we are already there.”
The report marks the first time the agency has provided hard numbers for the incidence, deaths and cost of all the major resistant organisms. (It had previously estimated illnesses and deaths from some families of organisms or types of drug resistance, but those numbers were never gathered in one place.) It also represents the first time the CDC has ranked resistant organisms by how much and how imminent a threat they pose, using seven criteria: health impact, economic impact, how common the infection is, how easily it spreads, how much further it might spread in the next 10 years, whether there are antibiotics that still work against it, and whether things other than administering antibiotics can be done to curb its spread.
In a recent message to subscribers, American Psychiatric Association President Jeffrey Lieberman urged members to support big pharma.
He did this while openly admitting that the pharmaceutical industry makes a practice of advertising unethically, paying off doctors, and suppressing critical scientific data as to the dangers of their drugs.
In 2006, Lieberman co-signed a letter to the editor of The Wall Street Journal with about thirty other doctors. With this, he disclosed honoraria, consulting fees, research grant support from AstraZeneca, Bristol-Myers Squibb, Upjohn Pharmacia, Novartis, Eli Lilly, Janssen, Pfizer, Hoechst AG, and AstraZeneca. He also listed as corporate speakers bureaus AstraZeneca, Janssen, Eli Lilly, and Pfizer.
Lieberman disclosed in 2007 in the journal Primary Psychiatry that he was a consultant to Eli Lilly and Pfizer. He was on the advisory boards of AstraZeneca, Eli Lilly, GlaxoSmithKline, Lundbeck,Organon, and Pfizer. He has a patent from Repligen Corporation. Lieberman received research support from Acadia, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck, Organon, and Pfizer. In 2009, Lieberman disclosed grants from Allon, Forest Laboratories, Merck, Pfizer, AstraZeneca, Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Janssen, Otsuka, Solvay, and Wyeth to the American College of Neuropsychopharmacology for their annual meeting in which he participated.
In 2011, his disclosure at Medscape of relevant financial relationships says he served on the advisory board of Bioline, GlaxoSmithKline, Intra-Cellular Therapies, Eli Lilly, Pierre Fabre, and Psychogenics, and that he received research grants from Allon Therapeutics, GlaxoSmithKline, Ortho-McNeil-Janssen, Merck, Novartis, Pfizer, Sepracor, and Targacept.
He also disclosed in 2013, as a member of the psychiatry editorial board at Medscape, that he received research grants from Allon, Novartis, Sepracor, and Targacept; and he served on the advisory boards at Bioline, Intra-Cellular Therapies, Pierre Fabre and Psychogenics. In additional disclosures at Medscape in 2013, he received research grants from Allon, GlaxoSmithKline, Eli Lilly, Merck, Novartis, Pfizer, Psychogenics, Hoffmann-La Roche, Sepracor, and Targacept, and he served on the advisory board of Alkermes, Bioline, Intra-Cellular Therapies, Pierre Fabre, and Psychogenics.
In “The Epidemic of Mental Illness: Why?” (New York Review of Books, 2011), Marcia Angell, former editor-in-chief of the New England Journal of Medicine, discusses over-diagnosis of psychiatric disorders, pathologizing of normal behaviors, Big Pharma corruption of psychiatry, and the adverse effects of psychiatric medications. While diagnostic expansionism and Big Pharma certainly deserve a large share of the blame for this epidemic, there is another reason.
A June 2013 Gallup poll revealed that 70% of Americans hate their jobs or have “checked out” of them. Life may or may not suck any more than it did a generation ago, but our belief in “progress” has increased expectations that life should be more satisfying, resulting in mass disappointment. For many of us, society has become increasingly alienating, isolating and insane, and earning a buck means more degrees, compliance, ass-kissing, shit-eating, and inauthenticity. So, we want to rebel. However, many of us feel hopeless about the possibility of either our own escape from societal oppression or that political activism can create societal change. So, many of us, especially young Americans, rebel by what is commonly called mental illness.
While historically some Americans have consciously faked mental illness to rebel from oppressive societal demands (e.g., a young Malcolm X acted crazy to successfully avoid military service), today, the vast majority of Americans who are diagnosed and treated for mental illness are in no way proud malingerers in the fashion of Malcolm X. Many of us, sadly, are ashamed of our inefficiency and nonproductivity and desperately try to fit in. However, try as we might to pay attention, adapt, adjust, and comply with our alienating jobs, boring schools, and sterile society, our humanity gets in the way, and we become anxious, depressed and dysfunctional.
The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.
Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs.
Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.
While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle.
[...] Susan is full of scorn for the psychiatric community’s readiness to label children as mentally ill then give them powerful and potentially damaging drugs. She’s become a vociferous critic on the subject, appearing at conferences and pressure groups.
She is particularly dismissive of the way psychiatrists often make their diagnosis using the profession’s ‘bible’ – the Diagnostic and Statistical Manual (DSM), just published in its fifth version (DSM-5).
The manual is written by an influential committee of American psychiatrists and lists official diagnoses and symptoms – its clinical definitions are used by professionals the world over as a guide for labelling psychiatric illnesses, and giving drug treatment.
One of the major criticisms is that the number of new psychiatric diagnoses added to it is rising exponentially. In 1952, the manual was 130 pages long. The fifth edition has 992 pages. And this latest edition has controversially added new diagnoses such as ‘Disruptive Mood Dysregulation Disorder’, which essentially makes children’s temper tantrums a mental illness.
Critics believe the manuals are “disease mongering” – inventing labels for conditions that don’t really exist, but are normal, albeit difficult, facets of human nature.
[...] As reporters who have long investigated healthcare and exposed frightening variations in quality, we wondered why so much secrecy shrouds the prescribing habits of doctors.
The information certainly isn’t secret to drug companies. They spend millions of dollars buying prescription records from companies that purchase them from pharmacies. The drug makers then use the data to target their pitches and measure success. But when we tried to purchase the records from the companies that supply them to drug manufacturers, we were told we couldn’t have them — at any price.
We next turned to Medicare, a public program that provides drug coverage to 32 million seniors and the disabled and accounts for 1 of 4 prescriptions written annually. We filed a Freedom of Information Act request for prescribing data. After months of negotiation with officials, we were given a list of the drugs prescribed by every health professional to enrollees in Medicare’s prescription drug program, known as Part D.
What we found was disturbing. Although we didn’t have access to patient names or medical records, it was clear that hundreds of physicians across the country were prescribing large numbers of dangerous, inappropriate or unnecessary drugs. And Medicare had done little, if anything, about it.
20 Signs That The Pharmaceutical Companies Are Running A $280m Money Making Scam ~ End of the American Dream
#1 According to a study conducted by the Mayo Clinic, 70 percent of Americans are on at least one prescription drug. An astounding 20 percent of all Americans are on at least five prescription drugs.
#2 According to the CDC, approximately 9 out of every 10 Americans that are at least 60 years of age say that they have taken at least one prescription drug within the last month.
#3 The 11 largest pharmaceutical companies combined to rake in approximately $85,000,000,000 in profits in 2012.
#4 During 2013, Americans will spend more than 280 billion dollars on prescription drugs.
#5 According to Alternet, last year “11 of the 12 new-to-market drugs approved by the Food and Drug Administration were priced above $100,000 per-patient per-year”.
#6 The CDC says that spending on prescription drugs more than doubled between 1999 and 2008.
#7 Many prescription drugs cost about twice as much in the United States as they do in other countries.
#8 One study found that more than 20 percent of all American adults are taking at least one drug for “psychiatric” or “behavioral” disorders.
#9 The percentage of women taking antidepressants in America is higher than in any other country in the world.
#10 Children in the United States are three times more likely to be prescribed antidepressants than children in Europe are.
#11 A shocking Government Accountability Office report discovered that approximately one-third of all foster children in the United States are on at least one psychiatric drug. In fact, the report found that many states seem to be doping up foster children as a matter of course. Just check out these stunning statistics…
In Texas, foster children were 53 times more likely to be prescribed five or more psychiatric medications at the same time than non-foster children. In Massachusetts, they were 19 times more likely. In Michigan, the number was 15 times. It was 13 times in Oregon. And in Florida, foster children were nearly four times as likely to be given five or more psychotropic medications at the same time compared to non-foster children.
#12 In 2010, the average teen in the U.S. was taking 1.2 central nervous system drugs. Those are the kinds of drugs which treat conditions such as ADHD and depression.
#13 The total number of Americans taking antidepressants doubled between 1996 and 2005.
#14 All of those antidepressants don’t seem to be working too well. The suicide rate for Americans between the ages of 35 and 64 rose by close to 30 percent between 1999 and 2010. The number of Americans that are killed by suicide now exceeds the number of Americans that die as a result of car accidents.
#15 According to the National Household Survey on Drug Abuse, 36 million Americans have abused prescription drugs at some point in their lives.
#16 A survey conducted for the National Institute on Drug Abuse found that more than 15 percent of all U.S. high school seniors abuse prescription drugs.
#17 According to the CDC, approximately three quarters of a million people a year are rushed to emergency rooms in the United States because of adverse reactions to pharmaceutical drugs.
#18 According to the Los Angeles Times, drug deaths (mostly caused by prescription drugs) are climbing at an astounding rate….
Drug fatalities more than doubled among teens and young adults between 2000 and 2008, years for which more detailed data are available. Deaths more than tripled among people aged 50 to 69, the Times analysis found. In terms of sheer numbers, the death toll is highest among people in their 40s.
#19 In the United States today, prescription painkillers kill more Americans than heroin and cocaine combined.
#20 Each year, tens of billions of dollars is spent on pharmaceutical marketing in the United States alone.
The American people deserve better than that. Every year, the United States spends more on health care than Japan, Germany, France, China, the U.K., Italy, Canada, Brazil, Spain and Australia combined. In fact, if the U.S. health care system was a separate nation it would be the 6th largest economy on the entire planet.
For all the money that we spend, we should be the healthiest people in the world by a wide margin. Instead, life expectancy is higher in dozens of other countries and we have very high rates of cancer, heart disease and diabetes.
Earlier this year, the authorities here began looking into suspicious activity involving a Shanghai travel agency that was rumored to have huge revenue but few bookings.
What they uncovered, they said Monday, was a conspiracy involving tens of millions of dollars, directed by senior executives at the British drug giant GlaxoSmithKline.
Investigators said that for years, high-ranking executives at the company’s China operations used travel agencies as money-laundering shops to funnel bribes to doctors, hospitals, medical associations, foundations and government officials.
The payoffs, investigators said, helped bolster drug sales and allowed GlaxoSmithKline, also known as GSK, to sell its products for higher prices in China.
Drugs companies have been accused of “highway robbery” of the NHS by using a legal loophole to push up the price of medicines in some cases by up to 2,000 per cent – at a cost to the taxpayer of tens of millions a year.
At least 15 drugs have substantially increased in price after being “flipped” from one firm to another, according to information obtained by doctors.
The legal “scam” has prompted outrage from the British Medical Association – which has warned that vital treatments risk being denied to patients if costs rise so much that the NHS can no longer afford them.
The controversial practice involves big-pharma firms selling on medicines commonly used by the NHS to businesses acting outside the Government’s price-regulation scheme. The purchasing firms are then free to mark up the prices they charge the NHS.
We’ve extensively documented that institutional corruption in the United States has led to a collapse in trust … which is hurting the economy.
And that the same thing is happening worldwide:
And that corruption has skyrocketed recently.
CBS News reports today:
According to a survey released Tuesday [by the international anti-corruption watchdog Transparency International], a majority of people across the globe feel that corruption has worsened in their countries, and that their governments are ineffective in combating it.
According to the survey, more than one in four people reported paying a bribe in the past year.
The survey asked respondents to rate the corruption level of their countries’ institutions on a one-to-five scale, in which five meant “extremely corrupt.”
Political parties were considered to be the most corrupt globally, with an average score of 3.8 out of 5.
“As political parties require money in order to run their campaigns, one of the big corruption risks for political parties is how they are funded,” Transparency International wrote in its report. “The interests of the people and organizations that fund political parties can have a large influence on the actions of those parties.”
Transparency International’s “Global Corruption Barometer” asked respondents to rate institutions on a corruption scale./ Transparency International
Political parties fared worse in the United States, where the 1,000 respondents surveyed gave them a corruption score of 4.1.
Globally, police came in a close second, with a corruption score of 3.7. Nearly a third of respondents who came into contact with police reported having paid a bribe.
And while 53 percent of respondents felt corruption had increased in the last two years, a majority also believed that their governments couldn’t fix the problem. According to the report, 54 percent of respondents view government as ineffective in combating corruption, up from the 47 percent recorded in Transparency International’s 2010-2011 survey.
“When there is widespread belief that corruption prevails and that the powerful in particular are able to get away with it, people lose faith in those entrusted with power,” Transparency International said.
In the survey, 54 percent of respondents felt that governments largely run for the benefit of self-interested groups. In the U.S., 64 percent said the government is run by a few big interests, compared with 5 percent who felt the same in Norway, and 83 percent in Greece.
CNN Money notes:
“The majority of people around the world believe that their government is ineffective at fighting corruption and corruption in their country is getting worse,” Transparency International said in the report, which was based on a survey of 114,000 people in 107 countries.
The surveys suggest that corruption cuts across societies and demographics.
“Impunity is anathema to the fight against corruption and, especially in the judiciary and law enforcement sectors, is a direct challenge to the rule of law,” the group said.
by Lawrence Hurley and Bill Berkrot
The U.S. Supreme Court ruled on Monday that generic drugmakers cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety.
In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co, owned by Sun Pharmaceutical Industries Ltd, overturning a multimillion-dollar jury award to a badly injured patient in New Hampshire who alleged a generic drug she had taken was unsafe based on its chemical design.
The majority opinion, written by Justice Samuel Alito, said the state’s law could not run against federal laws on prescription medicines whose design has been approved by the U.S. Food and Drug Administration.
A Supreme Court ruling in 2011 found that pharmaceutical companies that make branded drugs are liable for inadequacies in safety warnings of a medicine’s label, but not the makers of cheaper copies of those medicines.
Consumer watchdog group Public Citizen said the Supreme Court decision on Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.
by SARAH HARRIS
The Daily Mail
The number of drugs prescriptions to treat Attention Deficit Hyperactivity Disorder has leapt from 92,100 in 1997 to 786,400 last year, say NHS figures.
It is feared that youngsters are being given them instead of more expensive counselling and other treatments.
Some parents are also believed to be pressurising GPs for drugs to help boost performance at school.
Wired Editor’s Note: The controversial fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or DSM-5 (a.k.a. the manual formerly known as “DSM-V”) was just released – after a 14-year revision process to update its criteria for defining mental disorders. This opinion is from the former taskforce chairman and leader of previous DSM editions.
Editor’s Note: Allen Frances was chairman of the task force behind the previous (fourth) edition of psychiatrists’ widely-used Diagnostic and Statistical Manual.
by ALLEN FRANCES
Nature takes the long view, mankind the short. Nature picks diversity; we pick standardization. We are homogenizing our crops and homogenizing our people. And Big Pharma seems intent on pursuing a parallel attempt to create its own brand of human monoculture.
With an assist from an overly ambitious psychiatry, all human difference is being transmuted into chemical imbalance meant to be treated with a handy pill. Turning difference into illness was among the great strokes of marketing genius accomplished in our time.
All the great characters in myths, novels, and plays have endured the test of time precisely because they drift so colorfully away from the mean. Do we really want to put Oedipus on the couch, give Hamlet a quick course of behavior therapy, start Lear on antipsychotics?
I think not. Human diversity has its purposes or it would not have survived the evolutionary rat race. Our ancestors made it because the tribe combined a wide variety of talents and inclinations. There were leaders high on their own narcissism and followers content enough to be dependent on them; people who were paranoid enough to sniff out hidden threats, compulsive enough to get the job done, and exhibitionistic enough to attract mates. Perhaps the healthiest individuals were those who best balanced all these traits somewhere near the golden mean, but the best bet for the group was to have outliers always ready to step up to the plate as the particular occasion demanded.
by Holly Watt, Claire Newell and Ben Bryant
Pharmaceutical firms appear to have rigged the market in so-called “specials” – prescription drugs that are largely not covered by national NHS price regulations.
The prices of more than 20,000 drugs could have been artificially inflated, with backhanders paid to chemists who agreed to sell them.
Representatives of some companies agreed to invoice chemists for drugs at up to double their actual cost. Chemists would then send inflated invoices to the NHS, allowing them to pocket the difference.
Researchers find that nearly 70 percent of Americans are on at least one prescription drug, and more than half receive at least two prescriptions.
Mayo Clinic researchers report that antibiotics, antidepressants and painkiller opioids are the most common prescriptions given to Americans. Twenty percent of U.S. patients were also found to be on five or more prescription medications.
The study is uncovering valuable information to the researchers about U.S. prescription practices.
Nonprofits dedicated to fighting diseases are now providing seed money to pharmaceutical manufacturers in an attempt to get new treatments on the market for patients to use. But these new partnerships, known as “venture philanthropy,” have raised concerns over what the financial investments might do to the impartiality of disease charities when they have a stake in how well the new drugs perform and sell.
Despite their nonprofit status, organizations like the Cystic Fibrosis Foundation stand to make millions of dollars from helping a drug company add a new remedy to its stable of therapies.
In the case of the Cystic Fibrosis Foundation, it gave Vertex Pharmaceuticals $75 million to develop Kalydeco, considered a “breakthrough” drug that could reap big profits.
The foundation has already enjoyed a big return on its investment, collecting royalties on sales of the drug before selling its rights to future royalties to an investment firm for twice the amount it gave Vertex. Vertex, meanwhile, charges $307,000 a year for Kalydeco, with much of the money coming from Medicaid and other government-funded programs.
‘Nearly 1 in 5 children in the U.S. suffers from a mental disorder, and this number has been rising for more than a decade.
According to a study conducted by the Centers for Disease Control and Prevention, up to 20 percent of American children are suffering from mental disorders such as attention-deficit hyperactivity disorder (ADHD), anxiety, depression and autism.
The CDC’s first study of mental disorders among children aged 3 to 17 also found that the cost of medical bills for treatment of such disorders is up to $247 billion each year.
[...] The CDC data was collected between 1994 and 2011, and it shows that the number of children being diagnosed with mental disorders has been steadily growing. The study did not conclude exactly why the numbers are increasing.’
by Bruce Levine, Ph.D.
Mad In America
‘In my career as a psychologist, I have talked with hundreds of people previously diagnosed by other professionals with oppositional defiant disorder, attention deficit hyperactive disorder, anxiety disorder and other psychiatric illnesses, and I am struck by (1) how many of those diagnosed are essentially anti-authoritarians, and (2) how those professionals who have diagnosed them are not.
Anti-authoritarians question whether an authority is a legitimate one before taking that authority seriously. Evaluating the legitimacy of authorities includes assessing whether or not authorities actually know what they are talking about, are honest, and care about those people who are respecting their authority. And when anti-authoritarians assess an authority to be illegitimate, they challenge and resist that authority—sometimes aggressively and sometimes passive-aggressively, sometimes wisely and sometimes not.
Some activists lament how few anti-authoritarians there appear to be in the United States. One reason could be that many natural anti-authoritarians are now psychopathologized and medicated before they achieve political consciousness of society’s most oppressive authorities.
Why Mental Health Professionals Diagnose Anti-Authoritarians with Mental Illness
Gaining acceptance into graduate school or medical school and achieving a PhD or MD and becoming a psychologist or psychiatrist means jumping through many hoops, all of which require much behavioral and attentional compliance to authorities, even to those authorities that one lacks respect for. The selection and socialization of mental health professionals tends to breed out many anti-authoritarians. Having steered the higher-education terrain for a decade of my life, I know that degrees and credentials are primarily badges of compliance. Those with extended schooling have lived for many years in a world where one routinely conforms to the demands of authorities. Thus for many MDs and PhDs, people different from them who reject this attentional and behavioral compliance appear to be from another world—a diagnosable one.
I have found that most psychologists, psychiatrists, and other mental health professionals are not only extraordinarily compliant with authorities but also unaware of the magnitude of their obedience. And it also has become clear to me that the anti-authoritarianism of their patients creates enormous anxiety for these professionals, and their anxiety fuels diagnoses and treatments.
In graduate school, I discovered that all it took to be labeled as having “issues with authority” was to not kiss up to a director of clinical training whose personality was a combination of Donald Trump, Newt Gingrich, and Howard Cosell. When I was told by some faculty that I had “issues with authority,” I had mixed feelings about being so labeled. On the one hand, I found it quite amusing, because among the working-class kids whom I had grown up with, I was considered relatively compliant with authorities. After all, I had done my homework, studied, and received good grades. However, while my new “issues with authority” label made me grin because I was now being seen as a “bad boy,” it also very much concerned me about just what kind of a profession that I had entered. Specifically, if somebody such as myself was being labeled with “issues with authority,” what were they calling the kids I grew up with who paid attention to many things that they cared about but didn’t care enough about school to comply there? Well, the answer soon became clear.’
by Sarah Boseley
‘The international charity Save the Children is embarking on a partnership with a multinational drug company in a controversial move which the two organisations say is designed to save a million children’s lives.
A decade ago, Save the Children was among the development organisations lambasting GlaxoSmithKline, one of the world’s biggest drug companies, for its high price tags on HIV drugs for the developing world. The initiative launched by the two organisations on Thursday in Kenya will see Save the Children with a seat on the R&D board, advising on new products for the poorest countries, while GSK also pays for the training of more healthcare workers who will dispense medicines and give vaccines.’
by Charles Seife and Rob Garver
‘ProPublica [recently] reported that the Food and Drug Administration allowed dozens of medications to stay on the market, even though the research designed to prove their safety and effectiveness was undermined by “egregious” violations at a major pharmaceutical research laboratory in Houston. New information shows that even after the FDA had cited the lab for falsifying data and other misconduct, the agency issued a brand new approval to a drug tested there.
The FDA has refused to reveal the names of any of the approximately 100 drugs affected by the fraud at the Houston lab of the firm Cetero Research, saying that to do so would reveal confidential commercial information. ProPublica was able to identify five of those drugs, and now we’ve found a sixth. This one was approved after the agency had already cited the Houston lab for misconduct.’
Wall Street Journal
‘The U.S. government sued Novartis Pharmaceuticals Corp. again on April 26th, saying it paid kickbacks for a decade to doctors to steer patients toward its drugs, sometimes disguising fishing trips off the Florida coast and trips to Hooters restaurants as speaking engagements for the doctors.
The lawsuit in U.S. District Court in Manhattan came two days after the government brought a similar lawsuit against Novartis, which is based in East Hanover, N.J. The first lawsuit said the company paid kickbacks to pharmacies to switch kidney transplant patients from competitors’ drugs to its own.
In the second lawsuit, the government accused the company of using from 2001 through 2011 multimillion-dollar “incentive programs” that targeted doctors willing to accept illegal kickbacks to urge patients to use the company’s drugs.’
by Lisa Collier Cool
With some new, potentially lifesaving cancer drugs costing up to $138,000 a year, about 120 leading cancer specialists have joined forces in an unusual protest aimed at getting pharmaceutical companies to cut prices.
Charging high prices for drugs cancer patients need to survive is like “profiteering” from a natural disaster by jacking up prices for food and other necessities, leading cancer doctors and researchers from around the world contend in a new paper published in Blood, the journal of the American Society of Hematology.
Of 12 new cancer drugs that received FDA approval last year, 11 of them cost in excess of $100,000 a year—prices that the specialists attack as “astronomical,” “unsustainable,” and maybe even immoral. What’s more, only three of these drugs were found to improve patient survival rates and of these, two only increased it by less than two months, according to the Washington Post.
by Peter Lind
Gardasil, the vaccine for HPV (human papillomavirus), may not be as safe as backers claim.
Judicial Watch announced it has received documents from the Department of Health and Human Services (HHS) revealing that its National Vaccine Injury Compensation Program (VICP) has awarded $5,877,710 dollars to 49 victims in claims made against the highly controversial HPV (human papillomavirus) vaccines. To date 200 claims have been filed with VICP, with barely half adjudicated.
“This new information from the government shows that the serious safety concerns about the use of Gardasil have been well-founded. Public health officials should stop pushing Gardasil on children.” said Judicial Watch President Tom Fitton.
The CDC recommends the Gardasil vaccine, made by Merck Pharmaceuticals, for all females between 9 and 26 years to protect against HPV. Furthermore, the CDC says Gardasil is licensed, safe, and effective for males ages 9 through 26 years.