How Our Government Helps Drug-Dealing Doctors Kill Us

madinamerica
Lawrence Kelmenson, MD October 21, 2018
 
Psychiatry and Pain Management’s soaring profits since 1990 were fed by a unique combination of favorable circumstances never before seen: First, they’re paid mostly by federal funds. These include Medicaid, Medicare, and tax subsidies for employer-paid healthcare. But unlike other federally subsidized industries, health industry goods and services are covered by insurance, so high costs don’t deter client use of them. Just imagine all the fine food and posh restaurants we would access if we had hunger insurance that paid for them.

Mental health and pain treaters have advantages over other industries that rely on insurance payments: Medicare and Medicaid, being federally funded, are able to spend endless public money with few restrictions on coverage, regardless of cost. For example, Medicare costs jumped after a 2008 law raised mental health reimbursement from 50% to 80%.1 Private health insurers tried to rein in rising mental health costs, but were blocked by 1996,2 2008, and 20103 parity laws that forbade mental healthcare limits, copays, deductibles, or certification requirements from being greater than for physical care. This is part of why private insurance is now so costly.

To tap into this endless money, the pain and ‘mental illness’ fields made use of another advantage: Unlike events covered by other types of insurance, an illness is an arbitrary concept. Doctors can thus broaden its definition in order to broaden their domain: It can be a subjective physical perception with no clear or treatable source. For example, chronic pain became an illness. Illnesses do not even need to be physical: Painful thoughts and feelings, and kids acting like kids, also became illnesses. This was endorsed by a 1992 law4 that granted funds for services for the ‘one quarter who will suffer from mental disorders’, and for biomedically-focused mental illness research to be done at the NIH.

So, unlike other insurers that can verify house fires, car wrecks, or death, health insurers can’t verify mental illness or pain. Unlike other MDs, psychiatrists and pain doctors can invent infinite chronic (and thus lucrative) illnesses. Each client can be labeled with many different ones; there’s no limit. And each illness can justify a doctor’s luring the patient into lifelong addiction to euphoria-giving pills.

These MDs can also pad profits by putting clients on disability: Clients will then return regularly/eternally to prove ongoing disability, to ensure that their SSD checks and food/housing/healthcare assistance continue. Since they won’t work, they’ll have the time (and health insurance) to do so. A 1984 law5 made adult disability approval hinge on subjective functional impairment instead of objective disease evidence; this made mental illness (or chronic pain) easier to get SSD for. In 1991,6 the Social Security administration made child disability also hinge on functionality instead of illness proof. Child SSI cases rose five-fold soon after, mostly for mental illness.7 So illness-creators opened doors to disability benefits as well as insurance cash; that’s convenient, since their addictive ‘meds’ make it hard to work.

Two 1990 laws8 9 specified depression, ADHD, etc.to be valid causes of disability (before then, schizophrenia was the only ‘mental illness’ considered disabling). This further eased access to SSD/SSI funds. These laws also rewarded these illnesses by making life-easing accommodations available to those who ‘have’ them. For example, Billy prefers to play video games rather than do homework. By getting him labeled ADHD, his busy parents and teachers won’t have to struggle to teach him good work habits, since he’ll now be given less schoolwork (he’ll also be drugged into submission, so he won’t need to be raised). And his label may qualify his family for SSI, Medicaid, and other benefits.

400 million addictive prescriptions are filled yearly.10 It’s caused so much addiction and overdosing, including among kids who steal their parents’ pills, that the lifespans of white Americans have dropped steadily (they use 2.5 times as many psych11 and opioid12 ‘meds’ as non-whites). Then a 2000 law13 authorized doctors to treat the addictions they caused with yet more opioids (suboxone, or prison heroin). It’s such blatant drug-dealing that this law had to be enacted to make it legal (it circumvented a 1914 law14 that criminalized the prescribing of opiates to maintain addicts’ addictions). Suboxone is often peddled at drug rehabs, where clients thus score rather than quit drugs. Since the 2008 parity law made insurers cover treatment for addiction the same as for physical illness, these rehabs make a killing.

Mental health treaters capitalized on all these favors to become our most costly healthcare sector15 and a major cause of healthcare becoming our government’s top expense and top tax subsidy. Costs of other government programs also spiked, due to mental health, pain, and addiction treaters baiting and trapping millions into reliance on Social Security and other benefits. Since 2016, Congress has had to divert funds from the SS retirement to the SS disability trust fund,16 since the latter couldn’t keep up with all its mental illness and chronic pain claimants (its main recipients17). Businesses cut full-time workers in order to avoid paying their costly healthcare as is required by law. This drove yet more people to seek federal benefits. Nearly a fourth of Americans are on Medicaid now.

Psych drug and opioid prescribers are bankrupting us and exploding our debt. We spend more on healthcare and its addictive pills than all other nations, yet are still pounded by propaganda about “millions suffering needlessly from untreated mental illness.” Things will only get worse; many more mental health laws are on the way. 18 19 20 21 22 23 24 25 26
Deja Vu

Something similar actually did occur before: The British East India Company, aided by England’s parliament which invested in it, bailed it out, and made laws giving it monopolies, dominated trade in the East in the 1700s. It helped spread British colonialism there. In the 1800s, it profited greatly by growing opium in India and selling it in China. This hurt China’s economy by siphoning its silver and turning industrious Chinese people into idle, unproductive addicts. Its emperor finally halted opium imports after his son (China’s prince) died of an overdose (as did our “Prince”). The BEIC reacted by conquering, with British assistance, all Chinese ports and nearby areas, in order to ensure continued opium selling. This began what China calls its “century of humiliation” in which a great empire was brought to its knees and subjugated by England, France, and Japan.27

Are we at the start of our own lost century, with psych pill and opioid dispensers taking on the BEIC’s role? Like our drug-dealing doctors, it succeeded largely due to close alliance and support from its government every step of the way. The only difference is: Our own healers and leaders are killing us!


Show 27 footnotes

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Lawrence Kelmenson, MD

Lawrence Kelmenson has practiced psychiatry for 32 years, working with children, adults, and families. He graduated medical school from State University of New York, and completed psychiatric residency training at Cornell. He then became staff psychiatrist, and later medical director, of Craig House Hospital in Beacon, New York until 2000, and has since conducted a psychotherapy-based private practice in Cold Spring, New York. 

Thank You Dr Kelmenson and MIA.

Exposed: Hidden $$ Conflicts By FDA Drug Advisory Committees

AHRP
Vera Sharev June 8, 2018

A gangbusters investigative report by Science Magazine (July 2018) documents FDA’s disregard of substantial financial conflicts of interest by the advisory panel members that FDA selects. What’s more, the reporters uncovered a previously overlooked stream of company kickbacks to doctors on FDA advisory panels who voted to approve their drug.
 
Reporters Charles Piller and Jia You examined physician disclosure statements in publications by the Centers for Medicare & Medicaid Services, and analyzed the flow of payments to 107 physicians who served on FDA advisory committees that approved on 28 drugs between 2008 and 2014.

They examined (a) direct payments to physicians from companies whose drugs they voted on; (b) payments from competitors selling or researching drugs of the same class; and (c) corporate research grants to FDA advisers – either directly or through their institutions.  Among their key findings:

• Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and seven more than $1 million.
• Of the more than $26 million in personal payments or research support from industry to the 17 top-earning advisers—who received more than $300,000 each—94% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.

“Such money—including associated research funding” Science notes, affects a scientist’s career advancement, compensation, or professional influence.”  

Although FDA officials knew of those conflicts and cash kickbacks, they did not disclose those financial ties to the public or the medical community. Science Magazine (July 2018) cites  several dubious examples of FDA advisory panel recommendations. Approval of AstraZeneca’s drug Brilinta®  in 2010, which the company pitched as a drug that prevents heart attacks and strokes by reducing blood clotting. Science reports that:

“Before the Brilinta vote, the agency mentioned no financial conflicts among the voting panelists, who included four physicians. As Brilinta’s sales took off later, however, AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice. For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, Halperin got $7500 from AstraZeneca to study Brilinta, and the company separately declared nearly $2 million in “associated research” payments tied to him”.

The drug became a billion-dollar blockbuster selling at 25 times the cost of a currently available competitor, without commensurate clinical advantage.

A notorious example of the corrupt FDA drug approval process is the approval by two FDA advisory panels of Astra Zeneca’s antipsychotic drug Seroquel. In 2009, two FDA advisory panels approved expanded use of the drug for new conditions—schizophrenia and bipolar disorder in children, and depression in adults who are taking other medicines. Those approvals occurred despite evidence that Seroquel was linked to  sudden cardiac deaths when used with certain drugs. Indeed, several of the aggressively marketed antipsychotic drugs similar to Seroquel also had a record of cardiac fatalities.  But, as Science reports AstraZeneca presented results from its clinical studies, which company representatives claimed, at worst, showed only minimal risks. In fact, evidence from Seroquel clinical trials included suicides and gross negligence. [See Seroquel Archives]

In the years afterward, several FDA advisers received significant financial support from AstraZeneca and the makers of competing drugs. The biggest payments went to Duke cardiologist Christopher Granger, who sat on one of the two groups. From 2013 to 2016, the period recorded by Open Payments, he or Duke on his behalf received more than $63,000 from AstraZeneca and $1.3 million from competitors. According to conflict-of-interest disclosures in journal articles on which Granger was an author, he received additional, unspecified amounts from those companies between 2010 and 2012.

Granger says the industry funds solely underwrote research on cardiovascular topics and did not augment his salary. But according to the federal data, more than $400,000—including all of AstraZeneca’s portion—went to him for travel, consulting, and honoraria.
The next year, in 2010, AstraZeneca paid the government $520 million to settle lawsuits involving alleged improprieties in the company’s clinical trials and improper marketing of Seroquel for unapproved conditions. The company, which denied wrongdoing, pulled in more than $5 billion in revenues from the drug that year. In 2011, after mounting evidence of sudden cardiac deaths, FDA forced AstraZeneca to add a warning to Seroquel’s label that the drug posed risks of fatal cardiac events when combined with certain other drugs.

The agency’s financial review process is primarily an honor system and seems to miss obvious conflicts. For the 17 physicians receiving the most compensation after a drug advisory vote, Science examined whether they also received industry compensation concurrent with or shortly before their FDA service. Evidence of such payments came from conflict-of-interest statements in journal articles that those authors published near the time of their advisory role. Eleven physicians acknowledged support from competing companies on one or more drugs they reviewed. Five of those also received such funding from the makers of one or more of the drugs. Yet FDA publicly noted none of those apparent conflicts and issued no conflict waivers.

This is a ground breaking report by a widely read publication of the American Association for the Advancement of Science (AAAS); it clearly demonstrates that “disclosure” in publications is no barrier to corrupting financial ties between Pharma and influential academic medical experts. Dr. Carl Elliott, one of the very few honest medical ethicists points out: “Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest. A better way would simply be for the FDA to say, ‘We are not taking anybody with any kind of conflict on an advisory committee.’”

Posted by Vera Sharav | Friday, July 6, 2018 | Categorized FDA, Conflict of Interest, Pharma Corrupt Influence. 


Thank You Ms Sharav and AHRP.

Most Direct-To-Consumer Drug Advertisements Do Not Adhere To FDA Guidelines

Few DTC drug advertisements fully adhere to FDA guidelines, the overall quality of information provided in DTC advertisements is low, and some advertisements market off-label indications.

madinamerica
Shannon Peters March 30, 2018

A new study, led by Joseph Ross, associate professor of Medicine and of Public Health at Yale University School of Medicine, examines direct-to-consumer (DTC) drug advertisements. The results of the study, published in the Journal of General Internal Medicine, find that most DTC advertisements in the US do not fully adhere to US Food and Drug Administration (FDA) guidelines, the overall quality of information is low, and some market off-label indications despite this being explicitly prohibited.

“Though proponents argue that DTC advertising is educational and empowering for consumers, our findings suggest that the information provided is unreliable and potentially misleading,” write the authors.

The FDA has allowed DTC advertising in the US since 1985. Today, someone who watches an average amount of television will watch about nine drug advertisements each day, or 30 hours of advertisements a year. Drugs marketed through DTC advertising have increased demand by patients, higher rates of prescribing, and as a result, higher sales. Those who support DTC advertising suggest it empowers people to make informed medical decisions. Others who are cautious of DTC advertising worry it can lead to inappropriate or over-prescribing and have called to end DTC advertising.

The FDA requires that drug companies provide the Office of Prescription Drug Promotion (OPDP) with all advertisement materials and has regulations for what can and cannot be included in an advertisement. For example, DTC advertisements must list major risks in audio and are prohibited from suggesting any off-label uses for a drug (“off-label” refers to using a drug for a reason that has not been approved by the FDA). However, because of limited resources, the OPDP does not review every advertisement, and previous research has shown that many DTC advertisements do not follow FDA guidelines.

The aim of the current study, as described by the researchers, was to “assess the degree to which recently aired DTC ads for prescription drugs adhered to FDA regulations and guidelines” and “examine whether off-label use was suggested.” The researchers reviewed 97 DTC advertisements that aired in the US between January 2015 and July 2016.

The researchers find that the most common types of drugs marketed through DTC advertising are for inflammatory conditions (18%) and diabetes (16%). Psychiatric or neurological drugs made up 10% of the drug indications advertised. Over three quarters (76%) of the drug indications were for chronic conditions. Based on the traits of the main characters in the commercials, drugs were most commonly marketed to young or middle aged women.

“All advertisements included an approved use for the drug,” find the researchers. While there were no blatantly false statements in the advertisements, the researchers did find the information to be low quality and sometimes misleading. In addition, the researchers find that 13% of commercials, all for diabetes medication, “suggested non-FDA-approved—or off-label—uses, all of which were for weight loss and/or reduction in systolic blood pressure.”

The authors note, “only 26% (n = 25) of ads contained quantitative efficacy information” (e.g., the percentage of people who had successful results from a drug). In addition, “none of the commercials contained quantitative information regarding risks or side effects,” find the researchers. Although advertisements are required to audibly list all major risks, 22% had at least one risk only in the running text.

Another important finding was that 60% of DTC advertisements discussed potential savings or payment methods. The researchers highlight that, although drug coupons could reduce costs in the short term, the savings are often time-limited, and may result in a higher societal cost if people are choosing higher cost drugs over less expensive options.

The researchers summarize, “Our findings demonstrate that the quality of information in DTC television ads is low: none described drug risks quantitatively; only one-quarter described drug benefits quantitatively, and suggestions of off-label promotion were common for diabetes medications.”

“The promotion of off-label indications, poor quality of information, distracting risk presentations, and the fact that risks are never quantified could distort the perception of benefit and risk information,” highlight the authors. Therefore, the researchers call for more detailed regulations for what quantitative information about drug risks is required in DTC advertising. They also suggest the FDA charges a “user fee” to DTC advertisers, which could then fund more comprehensive oversight of advertisements. The authors conclude by reminding us why tighter regulations on DTC advertising are essential:

“Broadcast DTC advertising could lead patients to make healthcare decisions and request certain expensive, brand-name medications based on ads containing low-quality and incomplete information.”

Patients deserve quality, comprehensive information about drug benefits and risks in order to provide informed consent and be truly empowered in their healthcare decisions. In their current form, most DTC advertisements are misleading rather than promoting informed consent.

****

Klara, K., Kim, J., & Ross, J. S. (2018). Direct-to-consumer broadcast advertisements for pharmaceuticals: Off-label promotion and adherence to FDA guidelines. Journal of General Internal Medicine. Advance online publication. doi:10.1007/s11606-017-4274-9 (Link) 

Thank You Ms Peters and MIA.

FDA Asks Amazon, Ebay, Walmart, To Restrict Anti Diarrheal Meds Used By Opioid Addicts

washington examiner
Kimberly Leonard | Mar 1, 2018, 7:12 PM

The Food and Drug Administration sent a letter to online retail giants Thursday asking them to limit the sale of an over-the-counter, anti-diarrheal medicine that drug users are taking to mimic a euphoric high from opioids.

In a letter to Amazon, Ebay, Walmart, and Jet, FDA Commissioner Scott Gottlieb noted that a growing number of people are taking the drug loperamide in high doses, which can result in serious heart problems or death.

The FDA has become aware that people are taking these high amounts of the drug, a caplet often known by its brand-name Imodium A-D, as an alternative to an opioid, both to manage symptoms of withdrawal and to get high. Imodium is often known in drug circles as the "poor man's methadone." Methadone is often prescribed by doctors to treat people with addictions to heroin or prescription painkillers.

Drug users are able to obtain large quantities of loperamide online. Gottlieb noted in his letter that retailers were selling it in bundled amounts that could result in customers obtaining 1,200 tablets in a single purchase.

Gottlieb asked the retailers to voluntarily cease selling more than one package at a time and to include warning labels on their websites.

read more

FDA Chief Warns Feds May Force Big Pharma To Pull More Painkillers Off The Market

dailycaller
Steve BirrVice Reporter
5:02 PM 11/04/2017

The head of the Food and Drug Administration recently warned the agency will get much more aggressive with drug makers, potentially forcing companies to pull painkillers off the market.

FDA Commissioner Scott Gottlieb addressed the National Press Club in Washington Friday, arguing the current opioid epidemic requires a much more “intrusive” response from federal regulators than previously expected. Gottlieb said that over the past decade the government failed to address the looming crisis, despite being aware of mounting problems concerning opioid addiction, reports The Washington Examiner.

The FDA will enact stricter standards for their own product review and approval process, including evaluating if the risks for abuse of the drug outweigh the legal benefits of the product. Popular painkillers previously approved by the FDA can be crushed up for snorting or injection.

“To try to get ahead of it now, I think we need to be willing to take much more dramatic action, be much more potentially intrusive than what we thought we might have to do and what would have been our comfort zone five years ago or 10 years ago,” Gottlieb said Friday, according to The Washington Examiner.

For the first time in history, the FDA ordered a drug maker to pull a medication off the market June 8 due to widespread reports of abuse. Endo Pharmaceuticals announced the decision to comply with the FDA request July 6 following an internal review of the drug.

The unprecedented move came in the wake of reports patients were crushing up the pills to inject. Representatives for Endo said they stand by the safety profile of Opana ER and believe the benefits outweigh the risks. They say the pill is safe and effective when administered properly, but will comply and work with the FDA on the issue.

The move reflects the FDA’s new focus on not just the prescribed risks of painkillers, but the risks posed by illegal abuse of the pills.

President Donald Trump declared the opioid epidemic a “public health emergency” Oct. 26, giving states hit hard by opioid addiction flexibility on how they direct federal resources to combat rising drug deaths.

Data from the National Institute on Drug Abuse released Sept. 7 predicts that the addiction epidemic in America will continue to deteriorate, pushing drug deaths to an estimated 71,600 in 2017. If the estimates prove accurate, 2017 will be the second year in a row that drug deaths surpass U.S. casualties from the Vietnam War.



Thank You Mr Birr and the DC.

DOJ: Almost 60,000 Drug Overdose Deaths In 2016, Largest Annual Increase In American History

The FDA: hard at work 'Speeding Approval of New, Life Saving Medications" by getting as deep into bed with drug makers as they physically can.

CNSNews

By Susan Jones | June 7, 2017 | 6:32 AM EDT



(CNSNews.com) – “For Americans under the age of 50, drug overdoses now are the leading cause of death,” Deputy Attorney General Rod Rosenstein told employees of the U.S. Drug Enforcement Administration on Tuesday.

“On an average day, 90 Americans will die from an opioid-related overdose. About four people will overdose and die while we sit here this morning,” Rosenstein said.

Outlining the “horrifying surge in drug overdoses,” Rosenstein noted that in 2015, more than 52,000 Americans lost their lives to drug overdoses, 33,000 of them from heroin, fentanyl and other opioids.

“The preliminary numbers for 2016 show an increase to almost 60,000 deaths. That will be the largest annual increase in American history,” Rosenstein said.

And the opioid crisis is posing new dangers to law enforcement and other first responders, he warned:

Fentanyl is 30 to 50 times more deadly than heroin. Just 2 milligrams – the equivalent of a few grains of table salt – an amount that can fit on the tip of your finger – can be lethal.

Fentanyl exposure can injure or kill innocent law enforcement officers and other first responders. Inhaling just a few airborne particles could be fatal. Our police officers and first responders face this danger every day.

This is not a hypothetical problem. Law enforcement officers have already suffered exposures to fentanyl in New Jersey, Georgia, and Connecticut…Just a few weeks ago, a police officer in East Liverpool, Ohio nearly died from exposure to an extremely potent opioid, most likely a fentanyl-related compound. The officer had pulled over a car and noticed an unidentified white powder in the vehicle. The officer took precautions by putting on gloves and a mask for personal protection.

When the officer returned to the police station, another officer pointed out that he had powder on his shirt. Instinctively, he brushed off the powder while not wearing gloves. About an hour later, he collapsed. That officer had to be treated with four doses of naloxone. Luckily, he survived and is recovering.

Three weeks ago, a sheriff’s deputy in my home state of Maryland responded to an overdose scene. He was exposed to opioids and needed a dose of Narcan to reverse the effects.

The spread of fentanyl means that any encounter a law enforcement officer has with an unidentified white powder could be fatal.

Only a few grains of fentanyl, the amount shown here, is enough to kill a grown man who touches it, inhales it, or ingests it.

The DEA this week released a video message to law enforcement nationwide about the dangers of coming into contact with fentanyl.

Acting DEA Administrator Chuck Rosenberg is cautioning police not to field test any substance they suspect may contain fentanyl. Police dogs also are vulnerable.

“Something that looks like heroin could be pure fentanyl—assume the worst,” he said. “Don’t touch these substances or their wrappings without the proper personal protective equipment.”

The DEA has just issued guidelines for proper handling of fentanyl.

In addition to wearing gloves, face masks, eye protection and other protective gear, DEA says Naloxone (the opioid antidote) should be readily available for administration.

First responders should not eat, drink or smoke in places where fentanyl is suspected to be present.

Any opened mail and shipping materials located at the scene of an overdose with a return address from China could also indicate the presence of fentanyl.

And DEA says it is possible that fentanyl residue could be present on items of nondrug evidence such as currency, money counters, cellular telephones, or drug paraphernalia which could create an additional vulnerability to law enforcement.

Thank You Ms Jones and CNS.

And these are only the cases which GOT reported.

Risperdal Lawsuits Contribute To Johnson & Johnson's Legal Costs

prnewswire

News provided by Bernstein Liebhard LLP

Mar 13, 2017, 11:36 ET

NEW YORK, March 13, 2017 /PRNewswire/ -- Johnson & Johnson's legal costs grew by 480% last year, as Risperdal lawsuits and legal claims involving a number of other products continued to mount in 2016. According to a report that recently appeared in the Financial Times, more than 107,000 product liability claims were pending against Johnson & Johnson by the start of 2017, including more than 28,000 that were filed in 2016. Over 18,000 of the pending cases involve Risperdal, including many that allege the antipsychotic drug caused men and boys to develop gynecomastia, a condition marked by the growth of female-like breasts.

"Over the past several years, we have heard from numerous individuals interested in pursuing Risperdal gynecomastia claims, and our Firm still receives inquiries from prospective plaintiffs on a fairly regular basis. We are not at all surprised that this litigation continues to contribute to Johnson & Johnson's litigation costs," said Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to provide free legal reviews to men and boys who allegedly experienced excessive breast growth due to their use of the antipsychotic medication.

Risperdal Litigation

Risperdal is an atypical antipsychotic drug currently indicated to treat certain psychiatric disorders in adults and children. It was brought to market in the early 1990s, and received U.S. Food & Drug Administration (FDA) approval for its first pediatric indications in 2006. Plaintiffs pursuing Risperdal lawsuits over gynecomastia claim that Johnson & Johnson and its Janssen Pharmaceuticals unit concealed data linking its use to excessive male breast growth, and failed to provide doctors and patients with appropriate warnings regarding this risk. They also claim that the companies wrongly marketed Risperdal to treat children long before U.S. regulators approved the drug for any pediatric uses.

Risperdal litigations are underway in a number of state courts, including Missouri, New Jersey and Pennsylvania. Over the past two years, the mass tort program established for Risperdal lawsuits in the Philadelphia Court of Common Pleas has convened a number of trials. Several have concluded with verdicts in favor of plaintiffs, with judgments ranging from $500,000 to $70 million. Confidential Risperdal settlements have also been reached in some cases just prior to trial. (In Re: Risperdal Litigation, Case ID: 100300296)

Risperdal patients who experienced the growth of female-like breasts while using the medication may be able to pursue a lawsuit of their own. To learn more, please contact Bernstein Liebhard LLP by visiting the Firm's website, or by calling 800-511-5092.

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092

ATTORNEY ADVERTISING. © 2017 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info (at)consumerinjurylawyers (dot)com
http://www.rxinjuryhelp.com/
https://plus.google.com/115936073311125306742?rel=author

SOURCE Bernstein Liebhard LLP
Related Links http://www.bernlieb.com


Thank You PR Newswire and Bernstein Liebhard LLP.


Mental Health: Comes With FREE Sudden Death

Or as PhARMA's bagmen - the FDA - puts it:  

Hard At Work Speeding Approval of New Life Saving Medications.

FDA Commissioner Margaret Hamburg Named In Racketeering Lawsuit: Alleged  Conspiracy With JNJ To Increase Profits

"Former Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, her hedge-fund executive husband, and Fortune 500 giant Johnson & Johnson colluded to enrich themselves by failing to warn the public about a “deadly” antibiotic, a federal racketeering lawsuit claims.

“Once confirmed as FDA commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA commissioner to suppress material information to plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly,” the complaint alleges.

The suit was filed in the U.S. District Court for the District of Columbia Jan. 19, 2016, on behalf of five individuals who claim they suffered severe physical harm as a result of taking the antibiotic."

Read more: http://dailycaller.com/2016/04/21/suit-alleges-former-fda-chief-suppressed-danger-of-deadly-drug-for-sake-of-profit/#ixzz4bu2qMaeV

Trump's Health Sec Nominee Sought Special Treatment For Industry Donors

Kaiser Health News

By Marisa Taylor and Christina Jewett January 9, 2017

 

Rep. Tom Price, the physician and Georgia Republican tapped for the nation’s leading health care job, has long criticized federal spending as excessive. Yet during his years in Congress, he’s worked hard to keep federal dollars flowing to his most generous campaign donors.

Price has been a go-to congressman, a review of his records show, for medical special interests hotly sparring with regulators or facing budget cuts. Over the past decade, he has waded into issues related to specific drugs and medical devices, making 38 inquiries with the federal Food and Drug Administration, according to federal records obtained through the Freedom of Information Act. He questioned the FDA on his constituents’ behalf about matters as minute as a device for fertility treatment and an ingredient in pain creams.

In other cases, he has gone to bat for companies whose executives and employees have generously contributed to his campaigns and political action committees.

“It looks like he’s somebody who could throw the store open to a lot of niche special interests,” said Ross Baker, a political science professor at Rutgers University who specializes in Congress. “These are things that fly under the radar. If you take a meat ax to Medicare, for example, everybody would know about it. But this kind of stuff is done in the dark of night.”

Just a few weeks before Trump tapped Price to lead the Department of Health & Human Services in November, the congressman took the stage at an Atlanta conference for vendors who sell canes, hospital beds and power wheelchairs. Price was the star of the show — a conference with 5,000 attendees. He spoke to the gathered crowd about the Medicare cuts plaguing the industry and pledged to fight them. The leaders of the Medtrade conference honored Price with an award for his stalwart advocacy and convened a $100-per-person fundraiser in his honor.

Price, 62, a tea party Republican and orthopedic surgeon from the northern Atlanta suburbs, was elected to Congress in 2004 after four terms in the Georgia state Legislature. A third-generation physician, he has said he entered politics on a quest to limit government meddling in health care. He has won significant campaign support over the years from drug firms and physician groups.


Read More

Thank You KHN, Ms Taylor and Ms Jewett. 

Chief of FDA's Criminal Office To Depart As Trump Takes Office

business insider

By Sarah N. Lynch

WASHINGTON (Reuters) - George Karavetsos, director of the Food and Drug Administration's Office of Criminal Investigations (OCI), will depart the agency to join a private law firm, according to an internal announcement seen by Reuters.

Karavetsos in January 2015 became director of the 280-unit operation, which conducts criminal probes involving food, drugs, devices, cosmetics and tobacco.

His last day will be Jan. 20, the day Donald Trump is sworn in as president.

His departure was announced Tuesday by the FDA's associate commissioner for regulatory affairs, Melinda Plaisier, and Howard Sklamberg, the deputy commissioner for global regulatory operations and policy. read more


Thank You Business Insider and Ms Lynch


FDA Hiding Reports Linking Psych Drugs To Homicide

Risperdal Suit Filed Against HHS Sec Burwell, FDA and Sec Hamburg

FDA Chief Hamburg Named In Federal Racketeering Suit   JNJ, who else?

JNJ Settles Latest Risperdal Suit Before Trial

Why Donald Trump's Putative FDA Pick Could Scare Pharma

forbes

Matthew Herper ,  

Forbes Staff 

Yesterday, Bloomberg reported that Donald Trump is considering nominating venture capitalist and libertarian Jim O’Neill to head the Food and Drug Administration, and some in the pharmaceutical industry experienced an increasingly strong sense of nausea.

O’Neill, works at Mithril Capital, the firm founded by Paypal and Facebook backer Peter Thiel. That alone could normally serve to generate concerns about conflicts of interest with medical firms he helped to found. But O'Neill has also argued in the past that the lack of a functioning free market is the central fact that makes the current U.S. medical system overly expensive and wasteful. At a conference about creating new societies on ocean-rigged platforms, he argued that a better system would not involve government protections, that people should be able to pay others for organs used in transplants, and that the current system encourages bad health. “In a free market, you wouldn’t be forced to subsidize obesity,” he said in 2009.

But the quote that is causing the most unease is one about one of the FDA’s core missions: regulating drugs. In an August 2014 keynote at the Rejuvenation Biotechnology conference, O’Neill suggested: “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety--and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.”

Former FDA Commissioner Charged In RICO Lawsuit

That quote betrays a lack of understanding of how drug approvals actually work, or a commitment to rolling back the clock 50 years.

Most drugs are not safe. Instead, their benefits outweigh their risks. For instance, Iclusig, a drug used to treat a type of blood cancer, causes blockages in veins and arteries that can be deadly. But it is approved because the benefit, for cancer patients who have been failed by other drugs, is big enough that risk is worth taking.


Continue Reading.


Thank You Mr Herper and Forbes. 


Most Drugs Are Not Safe?

Most Psychiatric Drugs Are Not Even Legal.
(there, fixed it for you)

US 18C95 Sec 1958: Murder For Hire  


Many biotech entrepreneurs are actually fans of a tough FDA. At the Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer, the founder and chief executive of Regeneron Pharmaceuticals, said that he was against “making it really easy to get your drug approved” at the Forbes Healthcare Summit last week, before news of that O’Neill was under consideration leaked.

Schleifer said that he couldn’t compete with companies like Pfizer or Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron. But he can compete to get approved first, or to have a better drug that has more uses that the FDA allows it to advertise based on science.

“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” (???) Schleifer said.

PDUFA User Fee Archive

Hell of a ticket price to get into the Compete.

And one hell of an incentive to FDA to ALLOW unsafe, clinical trial rigged drugs to get and stay on the market.

Congressional Research Service: The Food And Drug Administration (FDA) Budget: Fact Sheet July 28, 2016

FDA Wants More Money, Claims They Are A 'Bargain'.


Crony Capitalism?

PDUFA must go.

New Federal Rules Target Woeful Reporting of Clinical Trial Results

Stat News

By CHARLES PILLER @cpiller

SEPTEMBER 16, 2016

WASHINGTON — Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.

The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.

A STAT investigation last year found widespread noncompliance with reporting requirements by both drug companies and academic institutions — including universities that are among the top recipients of government research funding, and by National Institutes of Health staff scientists. In the vast majority of cases, study results were reported long after statutory deadlines or not at all.

Yet not a single researcher or trial sponsor has been fined or penalized, STAT reported — though the Food and Drug Administration had the authority to fine violators more than an aggregate $25 billion since the law went into force in 2008.

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Thank You Mr Pillar and Stat News

color us, . . . . snooze.

With all the damage shrinks do to consumers day in and day out, . . . and can't connect the dots, . . . 

Does anyone believe this is more than just more butt covering?

Garbage In Equals Garbage Out, Systematic Reviews And Meta Analysis Can Tell Us A Flawed Story.

Feds To Spend $4.6 Million To Give 'Emotional Wellness' To Refugees

weaselzippers

When’s the government going to look out for our emotional wellness? [Ed: the Govt already IS, God damn the bought and paid for scumbags.] 

• Mind Control Tops U.S. Healthcare Spending

We’ve suffered from 8 years of the most deteriorating regime in history.

Via Free Beacon:

The Obama administration plans to spend $4.6 million next year on health promotion and “emotional wellness” for refugees as President Obama plans a 30 percent increase in the number of refugees admitted into the country.

The Department of Health and Human Services issued a grant forecast last month detailing its plans to issue health care grants for refugees on top of government programs that are already available, such as Medicaid.

“The Office of Refugee Resettlement (ORR) within the Administration for Children and Families (ACF) invites States to submit applications for Refugee Health Promotion (RHP) discretionary grant funds,” the grant forecast says. “The purpose of the RHP grant is to support health and emotional wellness among refugees. The program is designed to coordinate and promote local health and mental health services and education.”

Keep reading…

Thank You Nick and Free Beacon. 

FDA Reveals User Fee Rates For 2016

Prescription Drug User Fee Act (PDUFA)201620152014

New Drug Application (With Clinical Data)

$2,374,200$2,335,200$2,169,100New Drug Application (Without Clinical Data)$1,187,100$1,167,600$1,084,550New Drug Application Supplement With Clinical Data$1,187,100$1,167,600$1,084,550 - See more at: http://www.raps.org/Regulatory-Focus/News/2015/08/04/22960/FDA-Unveils-User-Fee-Rates-for-FY2016/#sthash.wlLFGhsQ.dpuf

Does that sound like a lot of money?

Johnson & Johnson Buys Pfizer Consumer Unit For $16.6 BILLION

To Pharma it's pocket change.

Ask yourself Who the FDA's real customers are, and where FDA's real loyalties lie.

And what has the public got out of it?

wiki on JNJ

Illegal marketing of Risperdal[edit]

Juries in several US states have found J&J guilty of concealing the adverse effects of Janssen Pharmaceuticals' antipsychoticmedication Risperdal, produced by its unit, in order to promote it to doctors and patients as better than cheaper generics, and of falsely marketing it for treating patients with dementia.^[66] States that have awarded damages include Texas ($158 million), South Carolina ($327 million), Louisiana ($258 million), and most notably Arkansas ($1.2 billion).^[67]

In 2010, the United States Department of Justice joined a whistleblowers suit accusing the company of illegally marketing Risperdal through Omnicare, the largest company supplying pharmaceuticals to nursing homes.^[68][69] The allegations include that J&J were warned by the U.S. Food and Drug Administration (FDA) not to promote Risperdal as effective and safe for elderly patients, but they did so, and that they paid Omnicare to promote the drug to care home physicians.^[70] The settlement was finalized on November 4, 2013, with J&J agreeing to pay a penalty of around $2.2 billion, "including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion."^[71]

Johnson & Johnson has also been subject to congressional investigations related to payments given to psychiatrists to promote its products and ghost write articles, notably Joseph Biederman and his pediatric bipolar disorder research unit.^[72]