Posts Tagged ‘pharmaceutical industry’

“Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley

Wednesday, November 24th, 2010
The Daily Nonpareil, November 24, 2010
By  Chuck Grassley, U.S. Senator

As Americans count their blessings during this season of thanksgiving, many of us can be thankful to gather around the holiday table with multiple generations of family and friends. More Americans are enjoying greater longevity and an improved quality of life well beyond retirement. In 21st century America, the bar of expectation has been raised for each successive generation not only to live the American Dream, but also to live longer and healthier than those before us. Many of us can thank modern medicine for creating breakthrough cures and treatments.

As the taxpaying public shoulders a growing share of the nation’s health care spending, it’s important now more than ever to protect the integrity of each tax dollar and strengthen the integrity of the U.S. health care system.

That’s why I’ve focused for the last several years to improve transparency and accountability between health care providers and the pharmaceutical and medical device industries.

In 2004 I began an inquiry regarding the financial ties between Food and Drug Administration advisory board members and the drug industry. Later, I broadened my scope to include the National Institutes of Health in order to assess its effectiveness in monitoring conflicts of interest between the industry and medical researchers.

It became clear more transparency was needed. In my work in public office, I’ve found sunshine to be very effective in revealing problems and promoting good behavior.

Starting in 2007, I led a bipartisan legislative effort to bring transparency to the financial relationship between drug and medical device makers and doctors conducting research or practicing medicine.   My “Physician Payments Sunshine Act,” which became law this year as part of health care reform, will require all payments above $10 from drug and device makers to physicians to be reported every year by the drug or device company. A user-friendly data base will be available to the public, so that anyone can see industry payments to physicians prescribing treatments and medical researchers conducting studies whose outcomes can significantly influence the commercial success of a drug or device.

The pharmaceutical industry spends tens of billions of dollars every year to market its products to providers. Some physicians receive industry payments for speeches, consulting activities, travel and research. While these payments are often a good and necessary part of drug development, they can also create bad behavior when kept hidden from the public.

In the past few years, congressional investigations and state gift disclosure laws have raised eyebrows about these financial connections, especially where the amount that has been publicly reported is vastly less than what has actually been paid. For example, a congressional review I led from my position on the Senate Finance Committee revealed a troubling financial link between a drug maker and a child psychiatrist at Harvard, whose work led to a significant spike in diagnoses of pediatric bipolar disorders and prevalent use of antipsychotic medicines for children.

Separately, an orthopedic surgeon at the University of Wisconsin received more than $19 million from a medical device company, although he reported only receiving “more than $20,000” per year on his financial disclosure records to the university.

My sunshine legislation that’s now law will require the pharmaceutical and device industries to collect information on their payments to physicians beginning in 2012 and submit it to the Department of Health and Human Services by March 2013 and annually thereafter. The Department of Health and Human Services is required to make that payment information available to the public starting in September 2013. Some within the industry already are developing self-reporting requirements in response to the effort.

While I’m glad to see companies, manufacturers, universities and even the National Institutes of Health are getting a head start to increase disclosure, I’m concerned the information could create even more confusion because the data is not standardized.

That’s why I am working closely with the Department of Health and Human Services to ensure the implementation of the sunshine law works as intended. That means the data must be made available in a timely, user-friendly format.

This effort has been part of my continued work to build openness and establish accountability for taxpayers. Banning anonymous “holds” in the U.S. Senate would shine the light of day on lawmakers who delay the people’s business. I’ve said lawmakers who take issue with a specific bill or nomination ought to have the guts to stand up and say so.

Likewise, creating a meaningful database of financial ties between Big Pharma and medical researchers ought to strengthen our health care system. Financial ties should withstand the light of day.

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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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Antipschotic Drugs—Side Effects May Include Lawsuits

Monday, October 4th, 2010

The New York Times
By Duff Wilson
October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

cover
Department of Justice Statements on the Five Major Companies Selling Anti-Psychotic Drugs:
AstraZeneca
Bristol-Myers Squibb
Eli Lilly
Johnson and Johnson
Pfizer

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects like drowsiness, nausea, weight gain, involuntary body movements and links to diabetes are listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Tony Jewell, an AstraZeneca spokesman, said last week that the company had turned over all that material to the F.D.A. as part of the approval process and updated its label over the years to show the latest safety information.

Dr. Stefan P. Kruszewski, a Harvard-educated psychiatrist who once worked as a paid speaker for several drug makers, became a government informant and now consults for plaintiffs suing drug companies. Earlier in his career, he spoke at events for Pfizer, GlaxoSmithKline and Johnson & Johnson as an advocate of antipsychotics. He said one company offered him incentives of $1,000 or more every time he talked to an individual doctor about one of its drugs.

“When I started speaking for companies in the late 1980s and early ’90s, I was allowed to say what I thought I should say consistent with the science,” he recalls. “Then it got to the point where I was no longer allowed to do that. I was given slides and told, ‘We’ll give you a thousand dollars if you say this for a half-hour.’ And I said: ‘I can’t say that. It isn’t true.’ ”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

Read entire article:  http://www.nytimes.com/2010/10/03/business/03psych.html?_r=2

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Sex, Lies and Pharmaceuticals—How Female Sexual Dysfunction (a “mental disorder”) was invented by the drug industry

Friday, October 1st, 2010

The Independent
By Jeremy Laurance
October 1, 2010

Female sexual dysfunction – which is claimed to affect up to two thirds of women – is a disorder invented by the pharmaceutical industry to build global markets for drugs to treat it, it is claimed today.

Drug companies have invested millions in the search for a female equivalent of Viagra, so far without success. But while doing so they have stoked demand by creating a buzz around the disorder they have created, according to Ray Moynihan, a lecturer at the University of Newcastle in Australia.

Corporate employees worked with medical opinion leaders, ran surveys aimed at portraying the problem as widespread and helped create the diagnostic instruments to persuade women that their sexual difficulties deserved a medical label. But sex problems in women are far more complex than they are in men, encompassing lack of desire, lack of arousal and lack of orgasm and the drug industry’s narrow focus is failing them.

Mr Moynihan, who first investigated the drug industry’s role in female sexual dysfunction a decade ago, says it illustrates a wider problem about the creation of new diseases, and the widening of existing boundaries for treatment with designations such as pre-diabetes, pre-hypertension and pre-osteoporosis, for which the latest treatments are aggressively promoted.

In his new book, Sex, Lies and Pharmaceuticals, which is previewed in the British Medical Journal, he says: “Drug marketing is merging with medical science in a fascinating and frightening way. Perhaps it is time to reassess the way in which the medical establishment defines common conditions and recommends how to treat them.”

In 2005, Pfizer, makers of Viagra, funded a survey which showed 63 per cent of women had sexual dysfunction and that testosterone and Viagra might be helpful. In 2006, Procter and Gamble, makers of a testosterone patch for women, sponsored a survey showing one in 10 postmenopausal women had hypoactive [low] sexual desire disorder (the company sold its drug business in 2009). In 2008, Boehringer Ingelheim, makers of flibanserin which is claimed to boost the female libido, sponsored a survey which also showed one in 10 women was in need of help.

Efforts by the companies to meet the need have subsequently foundered. Pfizer pulled Viagra from the market for women after trials showed it had no greater effect than placebo. Procter and Gamble’s testosterone patch was rejected in 2004 in the US, over fears it raised the risk of cancer and heart disease and Beohringer Ingelheim’s drug, flibanserin, was rejected by the US Food and Drug Administration in June on the grounds it had failed to deliver the agreed benefits while carrying the risk of serious side effects.

Mr Moynihan warns that although the drugs have so far failed, more are in the pipeline and claims that “the drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacture”. A spokesman for Pfizer said: “We currently have no plans to develop medicines for FSD.”

Read entire article here:  http://www.independent.co.uk/life-style/health-and-families/health-news/female-sexual-dysfunction-was-invented-by-drugs-industry-2094578.html

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Doctors, Drug Companies, Politicians & Corruptions

Friday, August 20th, 2010

The Asian Tribune, August 21, 2010

By Shenali Waduge

They say there’s no money in healthy people. But, why is the pharmaceutical industry the most profitable industry in the world? It is because they have mastered the art of concocting the disorder, creating the drug for the disorder and then bombarding the public with advertisements to convince them they’re afflicted, leaving little choice but to get “prescribed”.

The growth in the pharmaceutical industry began to expand towards the 1970s. Pharmaceutical companies began to form mutual partnerships and began dominating the production of medicines. Advertising boomed making it possible for consumers to be enticed into believing there were miracle cures or drugs that would make people look young forever, increase sexual libido, maintain youthful looking skin with zero after effects or side effects.

Companies spend billions on “inventing” new drugs…they also spend billions on marketing them, USD53billion to be precise. But, how “innovative” are these companies? Most research and clinical trials are carried out at universities and funded by Governments. What happens thereafter is that drug companies “buy these innovations” and quickly patent them and quickly set up manufacturing plants. The only “innovation” done by these companies is to modify the existing drug something as minor as changing the color of the coating! A patented drug generally lasts for 20 years. It is only after rigorous study and testing which takes a good 10 to 15 years that Governmental authorities grant permission to market and sell drugs.

Loopholes in patent systems ensure companies are able to keep generic competitors at bay for years. These patented branded drugs naturally provides high profit margins but before the patent expires and competitors enter with a generic drug sold at far lesser prices, owners of branded drugs put out a generic version before the branded version expires…giving his company a head start in the sale of generic drugs. In 2006, the world had spent US$643billion on prescription drugs with US accounting for almost half of global pharmaceutical market. The US pharmaceutical industry is the most profitable of all businesses in the US.

It would not surprise anyone that companies spent up to $11billion annually on free samples, $6billion on sales representatives, $3billion on vague advertisements, we can only guess how many more billions is spent on bribing doctors, bribing researchers, bribing universities, bribing health officers, pharmacists, providing kickbacks and even running bogus “medical education” programs.

Essentially, what drug companies’ end up doing is using tax payer’s money to pay for medical research which they buy off, they then spend on massive advertising campaigns aimed at misleading the public about the effects of these drugs and “encourage” doctors to prescribe them!

Year in and year out drug companies end up the most successful industry with stunning profits part of which are used to buy off politicians and further promote themselves as champions of social responsibility and good corporate ethics!

There are no business ethics in the pharmaceutical industry – the industry is synonymous with money, profits, power and control. Pharmaceutical companies have mastered how to market social phobia/anxiety disorders in order to sell mind altering drugs. Does it not surprise and make you wonder why scores of people are being treated for mental disorders?

There are teenagers on anti-depressants and anti-psychotics because pharmaceutical companies want to ensure they have customers for life! Some prescription drugs are sold at more than 500,000% markup over the actual cost of their raw ingredients, naturally drug companies will do anything to sell more pills and it is why they end up inventing fictitious diseases and force parents to make addicts out of their children. There are scores of drugs available that are “habit-forming” tranquilizers?

Despite the number of drugs available why are people sicker than ever? Drugs have not helped people instead drug companies have made people addicted to drugs and suffering further from the side-affects of taking so many different combinations of drugs. In the US, over 100,000 Americans die annually from prescription drugs while a further 2million are injured by them.

The dominating companies in global pharmaceutical industry today are MERCK, Roche (fined in the US and Europe for participating in illegal price fixing cartel), Pfizer (ranked no.1, the makers of viagra the wonder drug of the 90s…. and probably soon to put out a drug that may do the opposite of viagra!), Bayer the inventor of Asprin….however hundreds and thousands of people die every year from prescription drugs? 27,000 people died of vioxx which is a nosteroidal anti-inflammatory drug which has been withdrawn over safety concerns associated with heart attacks, strokes. (though first approved in 1999 but withdrawn in 2004) It is believed that over 80m worldwide prescribed it in 2003 and its producer Merck and Co made sales revenues of US$2.5billion.

What is ironic is that there is not a single chronic disease which has been cured as a result of taking prescription drugs. What these drugs have done is to only treat the symptoms. Has chemotherapy proved scientifically accurate? It does shrink tumors but it adds nothing to a patient’s lifespan. The world is becoming sicker, fatter and more depressed than ever. The advice that people should listen to is not being given…eat healthy, avoid processed foods, avoid refined carbohydrates, avoid soft drinks etc…are rarely highlighted.

What’s more our doctors are duping us too…! In the US some mid-sized drug companies have close upon 1000 representatives lobby with companies spending over $5billion annually on sending these representatives to physician offices. The US spends $19billion annually on promotions, influencing doctors and other health professionals. As a result the physicians are lured into prescribing drugs associated with particular drug companies who ensure these physicians are well looked after and patients end up paying far more than they are required to as well as end up having to take another set of prescribed drugs to cut off the side-affects associated with the earlier drug!

Doctors are even paid to conduct fraudulent clinical trials on patients who are encouraged to take drugs for a 12month period to see its affects while the drug company profits through that particular year and the doctors enjoy the kickbacks as well. Some doctors who prescribe a particular drug company’s products and avoided competing drugs are even paid “consulting fees”. It is all a scam, and a vast majority of physicians become party to these unethical medical acts, pocketing the benefits & dosing up their patients with whatever drugs they’ve been told to prescribe. Doctors today are recipients of airfares & hotel expenses, luxury vehicles, even repairs and tyre replacements!

What is poignant and significant is that while physicians who may attend academic sessions with the thought of updating their know-how they are at the risk of being manipulated by pharmaceutical companies who pay high-profile scientists/physicians to speak on topics relevant to their products. Similarly, medical journals also help to promote specific products whose manuscripts are written by the pharmaceutical companies.

Essentially the public is at risk as a result of the direct and indirect relationships between pharmaceutical industry and the physicians. It certainly does breach professional ethics and may even bring dangers to patients.

Read the rest of this article here:  http://www.asiantribune.com/news/2010/08/21/doctors-drug-companies-politicians-corruptions

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NY Times—U.S. Broadens Bribery Inquiry Into Drug Makers—Federal Prosecutors Investigating Payments Made to Doctors

Tuesday, August 17th, 2010

The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010

At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.

In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.

But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.

Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.

More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.

Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.

Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.

“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.

Read entire article here:  http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp

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US Department of Justice Probes Corruption in Big Pharma; Glaxo, Pfizer, Bristol-Myers Squibb, Eli Lilly & Merck

Friday, August 13th, 2010

Financial Times
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.

Read entire article here:  http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
(free registration required)

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Pharmaceutical Industry and Psychiatry—Conjoined Twins Joined at the Wallet, by former Pharma rep turned whistleblower

Friday, July 30th, 2010

OpEdNews
By K. L. Carlson
July 30, 2010

“Unlimited spending! Schedule all the programs you can.” That was the management directive announced at the regional business meeting I attended when I first became a pharmaceutical rep. When I heard the announcement I felt like I was on an Enron train that was roaring down the tracks, and the company expected everyone to be on board. The company was giving its sales force unlimited funds to hire physicians as paid speakers, sometimes to influence other physicians to prescribe the company’s drugs, at other times to simply financially reward physicians who wrote high volumes of prescriptions every month for the company’s drugs.

Former Merck regional sales manager, Gene Carbona, told the New York Times that the only thing the company considered when selecting physicians to provide presentations was “the volume or potential volume of prescribing that the doctor could do.” This is true of all pharmaceutical companies. According to The Wall Street Journal (August 31, 2009), Eli Lilly alone paid physicians $22 million dollars in just the first quarter of 2009.

The higher a physician is on the influential ladder, the greater the financial rewards to be reaped. Pharmaceutical companies pay influential leaders who can sway public opinion and influence research. And the area of medicine receiving the greatest amount of pharmaceutical money is psychiatry. The American Psychiatric Association (APA) is the most drug industry financially supported medical association. In July 2008, Senator Charles Grassley’s demands that the APA provide an accounting of its finances revealed that in 2006 the pharmaceutical industry accounted for about 30 percent of the APA’s financing; more than $20 million dollars.

Read entire article here:  http://www.opednews.com/articles/Pharmaceutical-Industry-an-by-K-L-Carlson-100727-454.html

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Jury recommends major reforms in drug prescribing after investigation of 18-year-old’s suicide under the influence of Paxil

Wednesday, June 30th, 2010

Pharmalot
By Ed Silverman
June 30, 2010

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

Read entire article:  http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/

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“Drugging Pre-School Children: A crime against childhood—children as young as 2 prescribed powerful anti-psychotics”

Thursday, June 10th, 2010

The MetroWest Daily News
By Jacob Azerrad
June 10, 2010

In 2001, Harry Markopolos repeatedly warned the authorities about Bernie Madoff. No one listened. Only a serious downturn in the economy led to Madoff’s downfall. It’s not a Ponzi scheme, but once again, no one is listening and the red flags are everywhere. This time the victims are our very young, innocent children in the millions. Today, children as young as 2, are being prescribed powerful anti-psychotic medications. Side effects include tics, drooling, and incessant eating. Some children have gained up to 100 pounds and often progress to becoming diabetic.

Virtually nothing is known about the long-term impact of these medications. And no one seems to care. Certainly not the drug companies pushing these drugs, nor the doctors who have been coerced by the pharmaceutical industry and panicking parents alike into prescribing them. The increase in the use of anti-psychotics is directly tied to the rising incidence of one particular diagnosis, bipolar disorder. Experts estimate that the number of kids with this diagnosis is now more than one million and rising, making it more common than autism and diabetes combined. To treat it, doctors are administering medications that have yet to be approved for children. Mothers are legally medicating their two-year-olds with Risperdal to quiet their tantrums, Trileptal to stabilize their moods, and Clonidine to help them sleep.

This is not the old story about ADD or ADHD and the use of Ritalin or other approved drugs in use since the 1970′s. This is not about helping the child who fidgets and can’t concentrate in their elementary school classroom. This is about tens of thousands of energetic, outgoing, healthy, and normal 3- and 4-year-olds who just won’t sit still in Mommy and Me. It is those children who have now been diagnosed with a new and controversial diagnosis – Childhood Bipolar Disorder.

On Sept. 4, 2007, The New York Times stated that studies in the 1970s and 80s concluded bipolar disorder was rare in children, but between 1994 to 2003, there was an astounding 40-fold increase in the number of children diagnosed with bipolar disorder.

In a 2007 “60 Minutes” episode, Katie Couric focused on the short life of 4-year-old Rebecca Riley of Hull. Diagnosed with bipolar disorder at age 28 months, she was dead one year later from an overdose of a psychotropic drug cocktail. At one point, Couric asks Rebecca’s mother, who had been charged with her daughter’s murder, if she thought her child’s behavior might have been normal. That in fact, maybe little Rebecca was just exhibiting Terrible Two’s behavior.

On Nov. 19, 2008, the New York Times reported that 31 children who were diagnosed with Childhood Bipolar Disorder and given the drug Risperdal for tantrums died, and 1,176 suffered serious side effects.

Read entire article:  http://www.metrowestdailynews.com/opinion/x1602634540/Azerrad-Drugging-pre-school-children-A-crime-against-childhood

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