McClatchy: Drug research routinely suppressed

[Winehole23]

From diabetes drugs to spine surgery products, scandals involving concealed data have mounted. Consider the cases of two heart drugs that were the subject of Milwaukee Journal Sentinel stories:


For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing the drug provided no benefit in improving artery health. During that time the drug was heavily marketed to consumers in TV ads. The situation came to light in 2008 after a congressional investigation was launched.


In 2003, a clinical trial of Multaq, a drug that treated irregular heartbeat, was stopped because more patients who were getting the drug were dying than those who were getting a placebo. However, the study was not published until five years later.


In 2007, an independent analysis of the diabetes drug Avandia found that the drug increased heart attacks and cardiovascular deaths.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug's maker, GlaxoSmithKline, to turn over the data.


"Had the medical community known about this hazard, Avandia would likely never have become the world's largest selling diabetes drug," said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "Our ability to provide the best care for patients is dependent on access to all of the available clinical trial evidence, regardless of whether the study showed favorable results."



While much of the criticism of suppressed medical research has been aimed at drug companies, research data from medical devices also has been delayed, especially when it reflects negatively on a product.
Critics pointed to Medtronic's bone-growth stimulating back surgery product known as Infuse.


Last year, the Journal Sentinel reported that the results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers. The paper was written by surgeons who have received millions of dollars in royalties from other Medtronic spine products.


What's more, the authors of the belated paper downplayed the bone overgrowth, saying it did not harm patients, a claim that was flatly refuted by a doctor interviewed by the Journal Sentinel.


The doctor, an Oklahoma orthopedic surgeon, said two of his patients who were in the trial had to undergo additional surgery because the bone overgrowth was painfully impinging on nerve roots. One of the patients, a man who was in his 50s at the time, needed three operations - one for the implant, a second to remove the unwanted bone formation, and a third when the additional bone grew back yet again.

Read more here: http://www.mcclatchydc.com
http://www.mcclatchydc.com/2012/01/04/134756/drug-research-routinely-suppressed.html

[Winehole23]

it's even worse abroad:


GlaxoSmithKline Argentina Laboratories company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.


Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.


The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.



Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.


A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.
Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children's public hospital in Santiago del Estero when the studies wee being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”


“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

http://www.buenosairesherald.com/article/88922/gsk-lab-fined-$1m-over-tests-that-killed-14--babies

[boutons_deux]

BigPharma and BigMedicalDevice are nothing but corporations lying, cheating, and corrupting their way to bigger profits, no matter how many Human-Americans are maimed or killed.

[boutons_deux]

UCA getting away with pollution. UCA-lapdog Repugs want to kill the EPA completely, while Human-Americans want EPA untouched.

Legal Loopholes Allow Industry to Hide Hazardous Chemical Releases

Legal Loopholes Still Allow Mining and Oil & Gas Industries to Hide Hazardous Chemical Releases

The EPA analysis – of data released in October 2011 – indicates, as usual, that the metal mining industry is the nation’s largest toxic polluter, responsible for 41 percent of all reported toxics in 2010, or 1.6 billion pounds. This has been the case ever since the metal mining industry was required to report its toxic releases in 1997. The industry accounts for the vast majority of toxic heavy metals and metalloids released such as:

arsenic (96% / 280 million pounds)

mercury (92% of mercury / 4.4 million pounds)

lead (86% / 538 million pounds)

But perhaps the most significant toxics releases by our mines and oil and gas companies are those not included in the TRI.

As the EPA analysis explains, the metal mining industry successfully sued to exclude from the inventory most toxics in waste rock. Consequently, beginning with the 2002 reporting year, more than one third of the metal mining industry's toxics — which are still released into the environment every year — go unreported.

If included in the 2010 reporting year, the metal mining industry would have reported a whopping 2.1 billion pounds of toxic waste and accounted for almost half of all toxics reported in the United States.

This is especially significant because – thanks to loopholes in the Clean Water Act and a recent Supreme Court decision – mining companies can dump toxics directly into rivers, lakes and streams.

Additionally, and unfortunately, one of the most serious threats to our nation's drinking water supply —toxic releases from oil and gas companies — is left unknown.

http://www.earthisland.org/journal/index.php/elist/eListRead/epa_analysis_of_toxic_releases_highlights_need_for _stronger_federal_oversig/

[Winehole23]

^^^misfiled

[Winehole23]

The short of it (covered in depth by Michael Eisen (http://www.michaeleisen.org/blog/?p=807), and Razib tipped me off to the issue (http://blogs.discovermagazine.com/gnxp/2012/01/elsevier-funded-ny-congresswoman-carolyn-maloney-wants-to-deny-americans-access-to-taxpayer-funded-research/)) is that Carolyn Maloney, a congresswoman funded by Elsevier, which is a major for-profit publishing company, is trying to pass the Research Works Act, which would deny Americans free access to research funded by taxpayer money. Currently, any research funded by the National Institute of Health must be made freely available to the public 12 months after publication. You can see why for-profit publishing companies do not like this policy. After 12 months, they can no longer turn a profit on any research they publish that was funded by the NIH. From Eisen’s post:



The policy has provided access for physicians and their patients, teachers and their students, policymakers and the public to hundreds of thousands of taxpayer-funded studies that would otherwise have been locked behind expensive publisher paywalls, accessible only to a small fraction of researchers at elite and wealthy universities.


The policy has been popular – especially among disease and patient advocacy groups fighting to empower the people they represent to make wise healthcare decision, and teachers educating the next generation of researchers and caregivers.


But the policy has been quite unpopular with a powerful publishing cartels that are hellbent on denying US taxpayers access to and benefits from research they paid to produce.
http://blogs.scientificamerican.com/crude-matter/2012/01/07/the-research-works-act-would-deny-taxpayers-access-to-federally-funded-research/

[Winehole23]

(http://www.bloomberg.com/apps/quote?ticker=JNJ:US)Johnson & Johnson (JNJ) (http://www.bloomberg.com/apps/quote?ticker=JNJ:US) halted a clinical trial of its antibiotic Doribax after more pneumonia patients who took the product died and fewer were cured, regulators said. http://www.bloomberg.com/news/2012-01-05/j-j-halts-study-of-doribax-antibiotic-on-higher-death-rate.html

[Winehole23]

J&J, the world’s second-biggest seller of health-care products, stopped the study of 274 people in May on the advice of an independent monitoring committee, said Shaun Mickus, a company spokesman. He declined to say why Doribax failed and said the New Brunswick (http://topics.bloomberg.com/new-brunswick/), New Jersey-based company isn’t changing its advice for doctors or patients.



“The bottom line is Doribax is safe and effective when used according to its approved label,” Mickus said in a telephone interview.
same link

[Winehole23]

Johnson & Johnson (JNJ) (http://www.bloomberg.com/apps/quote?ticker=JNJ:US) agreed to pay $158 million to settle Texas officials’ claims that the drugmaker fraudulently marketed its Risperdal anti-psychotic drug, ending a trial over the allegations.

J&J’s settlement will resolve claims it defrauded the state’s Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders, the company said today. The state also claimed the New Brunswick (http://topics.bloomberg.com/new-brunswick/), New Jersey-based drugmaker downplayed the health risk of Risperdal.

“Under the terms of the settlement, Janssen will pay $158 million in full resolution of all claims in Texas,” Teresa Mueller, a company spokeswoman, said in an e-mail. “This settlement represents a resolution to claims brought by the state in 2004 for alleged Medicaid overpayment during the years 1994-2008, and will circumvent potentially lengthy and costly appellate activities.”
http://www.bloomberg.com/news/2012-01-19/johnson-johnson-to-pay-158-million-to-settle-texas-risperdal-drug-case.html

[Winehole23]

In June, a South Carolina judge ordered J&J to pay $327 million after a jury found the drugmaker liable for damages over its Risperdal marketing. The drugmaker vowed to appeal that award.

The company also lost a Risperdal case in Louisiana in October 2010, where on top of a $257.7 million jury award, a judge ordered the company to pay $73.3 million in attorneys’ fees and costs.



A Pennsylvania (http://topics.bloomberg.com/pennsylvania/) judge threw out the state’s case against J&J and Janssen in June 2010.



J&J and Janssen also have been sued over their Risperdal marketing by Alaska (http://topics.bloomberg.com/alaska/), Arkansas (http://topics.bloomberg.com/arkansas/), Louisiana, Montana (http://topics.bloomberg.com/montana/), New Mexico (http://topics.bloomberg.com/new-mexico/), Pennsylvania and Utah (http://topics.bloomberg.com/utah/). The Arkansas case is set for trial in March.



The Texas case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).
same

[boutons_deux]

peanuts. J&J won't change an iota of their predatory, corrupt marketing/sales practices.

penalties for maiming/killing customers and defrauding everybody are simply costs of doing business-as-usual

[Winehole23]

158M on top of 327M on top of 257M, plus 73M, on top of the 500M federal settlement, is hardly peanuts.

[boutons_deux]

go find J&J's total profits after tax/year

[Winehole23]

$1B is still nobody's pocket change

[clambake]

they'll appeal.....and magically the awards will be slashed or simply disappear. just give them some time to grease the halls of washington.

[boutons_deux]

and the penalties are tax deductible business expenses, costing taxpayers

[Agloco]

In 2007, an independent analysis of the diabetes drug Avandia found that the drug increased heart attacks and cardiovascular deaths.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug's maker, GlaxoSmithKline, to turn over the data.


"Had the medical community known about this hazard, Avandia would likely never have become the world's largest selling diabetes drug," said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "Our ability to provide the best care for patients is dependent on access to all of the available clinical trial evidence, regardless of whether the study showed favorable results."

All thiazolidinediones are bad for you tbh. Actos has been implicated in increased incidences of bladder cancer, and of course Rezzulin was banned many years ago.

Better living through chemistry.

[Trainwreck2100]

here's the thing heartless evil corporations, tend to act like heartless evil corporations

[CubanMustGo]

here's the thing heartless evil corporations, tend to act like heartless evil corporations

"Heartless evil corporations are people too." --- SCOTUS, Citizens United v. Federal Election Commission, January 21, 2010.

[Winehole23]

that's a slight misstatement. personhood wasn't really touched, but an attribute was. corporations (and labor unions) do have a free speech right, just like natural citizens, as a result Of Citizens United.


(See you in hell, James Bopp, Jr.!)

[Pelicans78]

There's no real proof that Actos causes bladder cancer. The evdence is sketchy at best. The fact is, people with diabetes are more prone to cancer anyway. Its just how it is. Also people with diabetes are more prone to heart attacks and strokes.

Medications do have side effects, but the diseases themselves are harmful enough as it is without the medications. Those diseases will kill more people than the medications themselves.

[Agloco]

There's no real proof that Actos causes bladder cancer. The evdence is sketchy at best. The fact is, people with diabetes are more prone to cancer anyway. Its just how it is. Also people with diabetes are more prone to heart attacks and strokes.

You're correct. Unfortunately, that's not what I stated. Direct causality and being linked with higher incidences obviously have different connotations. However, it's also evident that the incidence in patients who are on Actos for more than a year is higher than that for patients who do not take it. Type 2 DM is a confounding variable, sure, but one that was controlled for in the most recent European study. As an aside, it's been banned in a few countries over there.

Either way, it's a poor excuse for keeping patients on this medication when other viable alternatives such as GLP agonists or DPP inhibitors are available.

[Pelicans78]

You're correct. Unfortunately, that's not what I stated. Direct causality and being linked with higher incidences obviously have different connotations. However, it's also evident that the incidence in patients who are on Actos for more than a year is higher than that for patients who do not take it. Type 2 DM is a confounding variable, sure, but one that was controlled for in the most recent European study. As an aside, it's been banned in a few countries over there.

Either way, it's a poor excuse for keeping patients on this medication when other viable alternatives such as GLP agonists or DPP inhibitors are available.

Those medicines don't address insulin sensitvity as well as Actos or Metformin. Those other drugs basically secrete more insulin and also decrease glucagon which help, but most Type 2 diabetics already have insulin secreted. However, their body is resistance to the insulin. That's where drugs like Metformin and Actos help. They allow the body to be more sensitive to insulin. If someone is already on Metformin, then its fine to use GLP agonists or DPP inhibitors as a second line drug. But if they have kidney issues which alot of diabetics tend to have, then Metformin is contraindicated and now you have to find a drug that will increase insulin sensitivity. The DPP inhibitors aren't so great at that. Now Actos is contraindicated in patients with heart failure.

[Winehole23]

Steven Brill with a long article on J&J and Risperdal:


Compounding the problem for J&J’s business strategists, the FDA’s December 29, 1993, letter officially approving the sale of Risperdal warned that the agency would “consider any advertisement or promotional labeling for Risperdal false, misleading or lacking fair balance” if it stated or implied that “Risperdal is superior to haloperidol [Haldol].”


The letter was signed by Dr. Robert Temple, a highly regarded specialist in clinical trials who had joined the FDA in 1972.


“Our role is not to decide that one drug is more effective than another drug, or to say that they’re equally effective, even if one is much more expensive,” Temple, now the FDA’s Deputy Center Director for Clinical Science, told me. “If the data that the sponsor submits demonstrates that the drug is effective and the potential benefits of its intended use outweigh the risks, we approve it. But,” he added, “it has never been clear to me that Risperdal was more effective than Haldol, and we never allowed them to claim that.”


Later in 1994, when Janssen submitted for FDA approval some promotional materials meant for doctors who treat the elderly, it got back another letter bomb. This one struck at the heart of what the company’s strategic planners envisioned as a key market. “It would be misleading to suggest that the safety and efficacy of Risperdal has been established in the elderly,” the regulators wrote.


The following year, Janssen submitted a new proposal to the FDA to conduct studies among geriatrics that would justify expanding the label to meet those market aspirations. Again, the FDA refused to go along

“You appear to be exploring Risperdal’s potential value for a much broader and more diffuse clinical target, namely ‘behavioral disturbances in demented patients,’” Dr. Paul Leber of the FDA wrote. That label, he continued, “would also encompass a range of other clinical findings, e.g., anxiety, depression, agitation, aggressiveness, verbal outbursts, wandering, etc. that would not necessarily be considered psychotic manifestations.”


Seeming to anticipate the mental institutions and nursing homes that were a big part of the market targeted in Johnson & Johnson’s business plan, Leber added, “Some [of these symptoms] … might even be construed by some as appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of antipsychotic medications for inappropriate behavioral control.”

http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/

[Winehole23]

A year later, in August 1996, Janssen submitted another proposal to the FDA. This time, it involved expanding the label to include children. Again, the agency rebuffed the company, declaring, “Your supplement [to the approved label] proposes the expansion of Risperdal use into pediatric patients, however, you never state for what child or adolescent disorders Risperdal would be intended. Indeed, you acknowledge that you have not provided substantial evidence from adequate and well-controlled trials to support any pediatric indications, nor developed a rationale to extend the results of studies conducted in adults to children.”


“Your rationale for proposing this supplement,” the agency concluded, “appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged in some way in labeling.”

[boutons_deux]

$1B is still nobody's pocket change

Brill calculates J&J may in the end have to pay a total of $6 billion in settlements for its misconduct. But he estimates the company made $18 billion in profits on Risperdal, just within the United States (on $20 billion in domestic sales, and there was $10 billion more in sales abroad).

http://mobile.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html?_r=0

For BigCorp, Big Crime Pays Big. (eg, BigFinance now bigger, wealthier, more powerful, more influential after causing the criminal Banksters' Great Depression)

[Winehole23]

the cost of doing business is newsworthy in this case, even if it doesn't hurt or deter J&J.

also, it's a marker for the public at large of serious wrongdoing and unethical business practices.

[Winehole23]

public opinion and legal process aren''t powerless. they can and have ruined companies. not saying this will happen here, but one never knows.

[boutons_deux]

the cost of doing business is newsworthy in this case, even if it doesn't hurt or deter J&J.

also, it's a marker for the public at large of serious wrongdoing and unethical business practices.

no effective hurt, no deterrence, Corporate-Americans are teflon coated

the public at large doesn't care because the public has no way to hurt or deter BigCorporate-American criminals. They can be outraged, maybe just shrug, but they know nothing will change. And hope they aren't in the next crop of BigCorp victims.

BigCorp fucks America, and American can't unfuck themselves.

[Winehole23]

J&J rolled Texas and jacked up Medicaid payments:


The story begins when J&J’s previous antipsychotic medicine ended its patent life, so sales plunged as generics gained market share. In 1994, J&J released Risperdal as a successor, but the Food and Drug Administration said it wasn’t necessarily better than the previous version and in any case was effective primarily for schizophrenia in adults. That’s a small market, and J&J was more ambitious. It wanted a blockbuster with annual revenues of at least $1 billion.


So J&J reinvented Risperdal as a drug for a broad range of problems, targeting everyone from seniors with dementia to children with autism.


The company also turned to corporate welfare: It paid doctors and others consulting fees and successfully lobbied for Texas to adopt Risperdal in place of generics. This meant that the state paid $3,000 a year for each Medicaid patient taking it, rather than $250 a year for each, Brill says.

http://www.nytimes.com/2015/09/17/opinion/nicholas-kristof-when-crime-pays-jjs-drug-risperdal.html