Antidepressant Linked to Cause Autism When Used by Pregnant Women

A recent article from SFgate.com and other news sources indicates that a recent study published in Archives of General Psychiatry, looked at the possible role of maternal antidepressant use before and during pregnancy. Prenatal Children whose mothers take Prozac, Zolft, or similar SSRI antidepressants during pregnancy are twice as likely as other children to have a diagnosis of autism or similar disorder. The study of 298 autistic children in the Kaiser Permanente Northern California system found a two fold increase in risk of the disorder when mothers took antidepressants at some point in the year before giving birth.
The study doesn't prove that the antidepressants actually caused autism, but it shows that genetics is not the sole reason for autism. Environmental issue can cause autism and antidepressants appear to be a common cause. We hope and expect there will be more studies, but we are not surprised of the results.

"The problem with our 'treatment procedures' is that, unlike standard medical practices, we have no way to verify the true cause of the problem or the effectiveness of our 'solutions'. We have gone from hot/cold baths, to lobotomies, to electric shocks, to psychotropic drugs - with no proof of any kind. If other MDs treated a broken arm the way we treat the human brain they would be in court. And so, more and more, that is where we find ourselves." Dr. Thomas Szasz MD, chair of psychiatry, Syracuse University.

Antidepressants Do Not Work to Treat Autism Either

The U.S. Food and Drug Administration (FDA) has not approved any medications to specifically treat autism, but they have approved three SSRIs sertraline (Zoloft), fluoxetine (Prozac) and fluvoxamine (Luvox) to alleviate certain symptoms of the illness. But research indicated that these antidepressants also provide no benefits.
Another study found that the antidepressant citalopram (Celexa) is not any better than a placebo at alleviating autism symptoms. Additionally researchers concluded that studies of other antidepressants revealed the same results.

Besides not working, these antidepressants often cause major side effects, especially in young people. In the citalopram study, one child participant developed severe seizures from taking the drug. Even after being taken off it, the child continued to have seizures. Other children taking it had a hard time sleeping and concentrating. Hard time concentrating is a symptom of autism, so the study shows the so called alleviate is causing the problem.

It must be devasting for a mother to have an autistic child, but what is worse is the potential prescription of an antidepressant is actually causing the life long problem for the child. The responsibility lies heavily on the pharmaceutical companies that produced these drugs Eli Lilly(prozac), Pfizer(zolft), Solvay(Luvox), GlaxoSmithkline(Paxil), Forest Labs(Celexa). There are class action lawsuit currently by baumhedlundlaw.com, rxbirthdefects.com and others

Getting Rich Exposing Pharma Fraud

Eamon Javers of CNBC reported recently that A Florida Company called Ven-A-Care has become a profitable whistle blower against Pharmaceutical fraud.
Javers reported that in one case Ven-A-Care found that there appears to be a pattern of overbilling by some Pharmaceutical companies. These pharma firms are selling drugs to patients (mainly elderly) for a set amount and the pharmaceutical company would bill the US Government via Medicare and Medicaid 500 to 2000% markup.

In Dec. 2010 the US Justice Department announced that Dey Inc. Dey Pharma L.P. and Dey L.P. Inc. had agreed to pay $280 million to settle False Claims Act allegations, the Department of Justice disclosed via their website. The United States alleged that Dey reported false prices for the following drugs Albuterol Sulfate, Albuterol MDI, Cromolyn Sodium and Ipratropium Bromide. The Justice department indicated that the Dey Pharma inflated government payments where they charge the Medicare and Medicaid a higher amount over actual price paid by health care providers. This discovery was related by Ven-A-Care.

The Los Angeles times reports that a Texas jury ordered two subsidiaries of Icelandic pharmaceuticals company Actavis to pay $170 million for overcharging the Texas Medicaid program. This was also relayed by Ven-A-Care and they will be rewarded as a “relator”

Ven-A-Care filed whistleblower suits against drug companies in 18 cases thus far since 2001 with settlements to date according to the Los Angeles Times are at least $2.2 billion for state and federal governments and at least $380 million in whistle blower fees for the four partners involved in Ven-A-Care's litigation. Some other big named pharmaceutical companies have settled or were fined such as Bayer Inc., Abbott Laboratories Inc., B. Braun Medical Inc., Roxane Laboratories Inc.,and GlaxoSmithKline to name a few.

These are the kinds of wiki leaks the government likes as all injured benefit, especially the taxpayer and government. It also shows a pattern of immoral and unethical behavior of the pharmaceutical industry by overbilling, overprescribing, and erroneous positive tests of their drugs against placebos.

Almost $Billion Fine in DOJ GlaxoSmithKline Fraud Case, Whistle Blower Gets $96 Million

Bloomberg News By Justin Blum, David Voreacos and Andrew Harris Oct 26,2010
This is the complete Bloomberg article
GlaxoSmithKline Plc agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs.

Glaxo, the U.K.’s largest drugmaker, and the U.S. Justice Department announced the accord today, resolving a lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company.

“This is not something I wanted to do, but because of patient safety it was necessary,” Eckard, 51, told reporters following a Justice Department press conference in Boston. As a whistleblower, she will receive $96 million from the settlement money.

Glaxo was accused in court papers of selling tainted drugs under false pretenses. The medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to papers filed in federal court in Boston. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet.

The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement.

“We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers,” Carmen M. Ortiz, the U.S. Attorney in Boston, said at today’s news conference.

Guilty Plea

SB Pharmco Puerto Rico Inc., a Glaxo unit, agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs made at the now-shuttered plant, the Justice Department said. Glaxo said in July it had agreed in principle with the U.S. to pay 500 million pounds ($791 million) to resolve the investigation.

“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,” PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.

Eckard’s take is the largest ever for a single whistleblower, said Patrick Burns, spokesman for Taxpayers Against Fraud, a nonprofit Washington group that publicizes the use of legal means to combat fraud against the U.S. The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department said.

‘Serious Deficiencies’

Other drugs made at the plant include Kytril, an anti- nausea medication, and Bactroban, an ointment used to treat skin infections, the Justice Department said.

“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.

The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.

“We did not uncover any evidence that patients were harmed from these adulterated batches,” Ortiz said today. “It is critical we keep pressure on companies to follow FDA standards and play by the rules.”

Eckard’s complaint was joined by the states of California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New Mexico, New York, Tennessee, Texas and Virginia, as well as the District of Columbia, Chicago and New York City.

The case is U.S. v. SmithKline Beecham Corp., 04-10375, U.S. District Court for Massachusetts (Boston)

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Andrew M. Harris in Chicago at aharris16@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.

DOJ Targets Pharmaceutical Companies Globally in Corruption Probe

Financial Times FT.com
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

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