Source: The Independent
AstraZeneca will discipline more of its US sales team if allegations of illegal marketing tactics are proven to be true, the drug company’s chief executive promised. David Brennan’s comments came as more confidential training tapes surfaced on the internet, showing how sales reps for the company’s cancer drugs are encouraged to talk down rival products. AstraZeneca has begun an internal investigation into whether the tapes contravene a ban on comparing rival drugs that haven’t been tested against each other in a proper scientific study. The company’s critics, meanwhile, have passed the allegations to the US department of health and human services, which is monitoring AstraZeneca’s sales tactics following earlier ethical lapses. The new allegations come a fortnight after the company sacked a US marketing manager for comparing the doctor’s surgery to “a big bucket of money” and told his salesforce to go and “grab a handful”.

In 2003, the company admitted a string of illegal marketing practices, paid $355m (£178m) in fines and compensation to the US government, and promised to abide by a tough five-year “corporate integrity agreement” which promised that there would be no further ethical lapses by its US salesforce. If any of the new allegations are proven and deemed to be a breach of the agreement, the company might be fined again, or even banned from selling drugs to the US government. The story has been unfolding in slow motion through a number of industry websites and by the efforts of several bloggers, chief among them Peter Rost, a former Pfizer sales executive who has become a thorn in the side of the pharmaceutical industry. Dr Rost has testified to Congress about the dubious marketing practices of the industry, and written the book The Whistleblower: Confessions of a Healthcare Hitman. [more]

Source: America Blog
Why does the Bush administration have a list of everyone who has ever used anti-depressants? Guess what? They do. From ABC News, regarding the VA Tech shooter:

Some news accounts have suggested that Cho had a history of antidepressant use, but senior federal officials tell ABC News that they can find no record of such medication in the government’s files. This does not completely rule out prescription drug use, including samples from a physician, drugs obtained through illegal Internet sources, or a gap in the federal database, but the sources say theirs is a reasonably complete search.

We don’t even have a list of gun owners, and we have a list of everyone who has been prescribed anti-depressants? And in fact, the article suggests that this isn’t just a database of patients who use anti-depressants, it’s a federal database of every prescription drug you’ve ever bought. What exactly do the Bushies do with that list? And what other lists do they have of which medications you’ve ever taken?

Source: Pharmalot
AstraZeneca reps in the US aren’t the only ones struggling with overzealous managers. More UK sales reps are reporting inhouse misconduct and violations directly to the Pharmaceutical Medicines Code of Practice Authority, thanks to tougher code implemented last year.

Sales reps are afraid their careers will suffer if caught breaking the new rules, so authorities are seeing a small, but noticeable increase in the number of reps complaining about the call rate targets they’re given - rising from just one complaint in 2005 to four last year. The code says reps shouldn’t make unsolicited sales calls to docs more than three times a year on average. One recent case involved a Pfizer rep who complained about being asked to call on target docs eight times a year, and said other reps knew the target violated the rules and raised the issue, but that managers hadn’t acted. Pfizer claimed confusion, but was found in breach.

Sales reps “appear to be more willing to call their company to task if they feel they are being asked to breach the code,” says PMCPA director Heather Simmonds. “While I’m sure companies would prefer if these concerns were raised internally (and in some instances they were), the most important thing is that representatives are following the code.” There have been high-profile violations in the UK in which Abbott and Merck were suspended from membership in the Association of the British Pharmaceutical Industry. Other such as Lilly and Amgen have admitted to regulators recently hoping to show they take the rules seriously.

A former compliance officer at AstraZeneca, Steve Gray, says the tougher code means reps have to be constantly vigilant. “They’re the ones that have got to take a decision on the spot about what they can and can’t do. Some people are worried that if they make a mistake, their company is going to come down on them really heavily and they’ll get fired. I can’t think of a company where that’s true, but that doesn’t stop people worrying.”

Source: BBC
Five decades after the drug thalidomide caused an international scandal, it still casts a long shadow over pregnancy for many women. Women are now understandably worried about taking medication during pregnancy - even when they are quite ill. And some doctors are failing to prescribe certain medicines to their patients because of exaggerated fears. Thalidomide was used by pregnant women to ease sleep problems and pregnancy sickness. But side effects caused more than 400 disabled babies to be born in the UK in the late 1950s and early 1960s, before the drug was withdrawn. Dr Jim Kennedy, the Royal College of GPs’ head of prescribing, said the legacy of thalidomide had left its mark. [more]

Source: Seroxat Sufferers
When I first started researching into the whole Seroxat/GSK/MHRA scandal over 4 years ago I never anticipated the dirt and insidious characters I would come across… least of all from patient support groups for Mental Health. What is going on over at Primhe? [more]

Source: Brandweek
Most people have never heard of Berkeley Premium Nutraceuticals or its controversial CEO, Steve Warshak. But many people are familiar with Berkeley’s largest brand, Enzyte, which bills itself as “the once-a-day tablet for natural male enhancement.” Enzyte is promoted heavily on late-night cable TV with commercials that feature “Smiling Bob.” In the spots, Bob grins his way through golf games and pool parties while a double-entendre-laced voiceover talks about “working with wood,” and “a big new swing of confidence.” The product itself promises “fuller, firmer erections.”

Don’t laugh—Enzyte and Berkeley are serious business. At its peak the company grossed almost $250 million in annual sales and had more than 1,500 employees, making it one of Cincinnati’s major employers. But a considerable portion of Berkeley’s business is fraudulent, federal prosecutors say, because about $100 million of the company’s revenue over the years came from repeatedly billing thousands of customer’s credit cards for refills they did not order. [more]

Source: adrugrecall.com
Starting in the late 1990s, the families of a number of children diagnosed with autism have filed thimerosal lawsuits against manufacturers of thimerosal and childhood vaccines containing thimerosal. The thimerosal lawsuits seek financial restitution for medical expenses, lost wages, pain and suffering, and punitive damages. Defendants named in recent thimerosal lawsuits include seven different vaccine makers as well as five companies that produce the preservative.

The basis for thimerosal lawsuits lies in the connections drawn between exposure to high amounts of mercury and development of autism. A Center for Disease Control (CDC) report cited by some parents filing thimerosal lawsuits shows that originally, a study conducted by the CDC found that children exposed to 62.5 mcgs of mercury through vaccines in the first three months of life were 2.48 times more likely to develop autism. In a move that angered many plaintiffs in thimerosal lawsuits, researcher Thomas Verstraeten added more children to the epidemiological study, bringing the correlation down to 1.69 times. Verstraeten was subsequently hired as a consultant by vaccine manufacturer GlaxoSmithKline.

The first of the thimerosal lawsuits was filed following an FDA report in 1999 that stated “infants who received thimerosal-containing vaccines at several visits may be exposed to more mercury than recommended by federal guidelines for total mercury exposure.” Many thimerosal lawsuits point out the shocking results of a 1997 FDA order for the drug companies to reveal the amount of thimerosal included in their vaccines-the levels of mercury found in many pediatric vaccines exceeded the amounts considered safe for adults.

To date, numerous individual thimerosal lawsuits have been filed, in addition to a class action thimerosal lawsuit designed to force pharmaceutical companies to investigate whether thimerosal indeed causes autism and other forms of brain damage in children. The media attention generated by the rising number of thimerosal lawsuits has helped parents learn of the potential risks of childhood vaccines. Although the FDA ordered manufacturers of childhood vaccines to stop including thimerosal in 1999, there has as yet been no recall of vaccines containing mercury, and those stocks are still available to doctors.

Source: Moscow Times
Prosecutors in Volgograd on Monday charged three doctors at a local hospital with failing to safeguard the health of infants who were given an unregistered vaccine produced by a division of British pharmaceutical giant GlaxoSmithKline as part of a clinical trial.

The three doctors — Olga Alikova, former assistant to the chief physician at Independent Clinical Hospital; Tatyana Slizova, head of the hospital’s pediatric unit; and pediatrician Svetlana Alexeyeva — were charged following an investigation that began March 15, said Lidia Sergeyeva, a spokeswoman for the Volgograd regional prosecutor’s office. Prosecutors opened the investigation in response to a complaint from the parents of Vika Geraskina, who was 1 year old when she was purportedly given the vaccine in November 2005.

They maintain that Geraskina should not have been included in the list of 112 participants in the vaccine trial because she suffers from cerebral hypoxia, a lack of oxygen supply to the brain. After receiving the vaccine, which is designed to protect against chicken pox, measles and rubella, Geraskina’s health deteriorated, prosecutors said. Investigators concluded that both the law and the pharmaceutical company’s contract with the hospital were contravened, resulting in the inclusion of children with neurological disorders and chronic illnesses in the trial, prosecutors said in a statement released Monday.

Parents also believed that their children were receiving proven vaccines and were not informed about the trials, prosecutors said. Alexeyeva denied knowingly breaking the law. “We followed all the rules,” she said Monday by telephone from the hospital, which belongs to the regional railway company. “I am suffering psychologically from the pressure,” she said. Alexeyeva complained of sleepless nights after heated exchanges with the parents of the children who took part in the trial. Alexeyeva said she was in the process of hiring a lawyer. The other doctors, Alikova and Slizova, could not be reached for comment on Monday. All three could face up to six years in prison.

Michael Crow, the head of GlaxoSmithKline in Russia, dismissed the allegations as “untrue” at a news conference earlier this month. “All the parents agreed to the tests,” he said. Crow declined to comment on Monday.

The vaccines were produced by GlaxoSmithKline’s Belgian trading arm, which paid Alikova more than 1.5 million rubles ($57,670) for hosting the tests at the hospital, the prosecutor’s statement said. Slizova, the head of the pediatric unit, received some 700,000 rubles (just under $27,000). After consultations with Crow, a spokesman who declined to give his name said GlaxoSmithKline would only comment, “when we have a complete picture.” A March 16 statement from GlaxoSmithKline said any link between the adverse symptoms and the vaccine were “extremely improbable.”

Gennady Onishchenko, the country’s chief epidemiologist, said last month that Geraskina was part of a control group, and that her symptoms could not be a result of the tests because she was not given the specific vaccine in question. Prosecutors acknowledge that an independent panel comprising doctors, lawyers, priests and others had approved the trial.

GlaxoSmithKline contracted Independent Clinical Hospital to test its new vaccine in early 2005 — part of a national battery of tests that involved 1,000 babies in 10 cities, including Moscow and St. Petersburg. A statement posted on the company’s Russian web site said the company and health authorities had audited the Russian facilities involved in the trial and had discovered no violations. In February, a court ordered the Volgograd clinic to stop the trials. No date has been set for a hearing, Sergeyeva said.