The three drugmakers are being investigated over bribes allegedly paid to Saddam Hussein’s deposed Iraqi regime, Agence France-Presse reports. They were asked to hand over documents by the UK’s Serious Fraud Office, which is probing allegations of bribes paid to secure contracts in violation of the oil-for-food program that ran from 1996 to 2003. [UPDATE: The initial report didn't mention Lilly.]

In February, the Serious Fraud Office opened a formal probe into “issues relating to the breaches of the embargo” against Iraq, which could take up to three years. The oil-for-food program allowed Baghdad to sell oil in exchange for humanitarian goods the country lacked due to sanctions imposed after Iraq’s 1990 invasion of Kuwait. But the Iraqi government swindled millions of dollars from the scheme, sparking a scandal that caused huge embarrassment to the UN, AFP notes.

A UN report urged by former US Federal Reserve chairman Paul Volcker, which was released in October 2005, accused 2,200 companies from 40 countries of working with Saddam’s regime to bilk the oil-for-food program of $1.8 billion. Citing the report, Glaxo allegedly paid $1 million in kickbacks to win an $11.9 million contract. AstraZeneca allegedly paid $162,000 to win $2.9 million in contracts. And Lilly allegedly paid $343,000 in bribes to win $3.2 million in contracts.

The drugmakers denied any wrongdoing and said they were co-operating fully with the investigation. Glaxo “does not believe that its employees or its agents in Iraq knowingly engaged in wrongdoing regarding the oil-for-food programme,” a spokesman told AFP. “In fact, (Glaxo) went to considerable lengths to co-operate with UK government authorities responsible for the UK administration of the program and to impose anti-corruption measures when dealing with intermediaries in Iraq at a time when the environment was extremely volatile and difficult.”

An AstraZeneca spokeswoman says: “AstraZeneca has received a request from the SFO for documents as part of its review of the oil-for-food programme in Iraq. “The company will be providing the documentation.” A Lilly spokeswoman tells AFP the drugmaker would comply with the demand which was made in mid-December. “We are compiling these documents and they will be sent to the SFO in the new year,” she said.

As we ready ourselves for another day of relaxation with the short people, we thought it may be helpful to pass along a few items as you wind down the work week or continue your own vacation. Whatever your plans, we hope you enjoy…..

James Orlowski may not be the only doctor in the Tampa Bay, Florida, area who has given sales reps the boot. But he’s the only regional doc listed in the online directory of No Free Lunch, an organization opposed to accepting freebies from pharma, The St. Petersburg Times writes. Orlowski tells the paper that when he was a med student at Case Western Reserve University 33 years ago, no one discussed the ethics of accepting drug company gifts, and freebies like medical instruments and textbooks were hard to resist. “Then I saw research that showed these gifts have tremendous influence on prescribing practices, though physicians always deny it,” Orlowski says. “There’s no way I was going to let a drug company gift influence my decisionmaking.”

From peasant doctor to ceo of a fledgling biotech, Hu Fang’s rise parallels China’s economic transformation. At age 19, he was a “barefoot doctor,” ordered by the government to the frigid, mountainous province of Heilongjiang in northern China from his home near Shanghai, Bloomberg News writes. He was one of thousands of students sent to the countryside in the 1960s with little training and few supplies to care for the poorest Chinese. Now 57, Hu runs Shanghai Sunway Biotech, one of only two companies in the world to sell a gene-therapy treatmens. Hu’s career reflects the rise of China’s drug industry from marketers of herbal treatments to research-based companies exploiting advances that have fueled health-care breakthroughs in the U.S. and Europe. He is also benefiting from intellectual property laws that are less restrictive than in the West, lower costs and different regulations for human testing.

Ohio Supreme Court Upholds Damages Law (Associated Press)

Schering-Plough Warns R&D Costs Will Rise (Yahoo/Associated Press)

Mylan Gets OK To Ship Generic Zyrtec (Reuters)

Par Pharma Halts Study On Lung-Infection Drug For HIV (Yahoo/AP)

Endo Buys Rights To Alexza’s Inhailed Painkiller (Bloomberg News)

Glaxo’s Seretide Improves Lung Disease: Study (Yahoo/AP)

When Pfizer named Martin Mackay head of R&D in October, one of his first moves was to abolish all the committees he believed were blocking the path between good ideas and marketable drugs. What used to be as many as 14 layers of management between scientists and top executives have now been pared about in half, BusinessWeek writes.

Cutting red tape is a key element of his multifaceted plan to overhaul how the drugmaker develops new meds - from generating ideas to managing the trials needed to get them on the market, the mag continues. It’s a strategy he’s been fine-tuning since his predecessor, longtime R&D chief John LaMattina, announced his retirement in May. “I know it’s a bit pompous,” Mackay tells Busyweek. “I really knew what we needed to do differently.”

Wall Street, however, has not been wowed. Pfizer’s stock, the mag points out, has fallen 7 percent since Mackay was promoted. It doesn’t help that he’s associated with a legacy of blunders: He was part of the upper echelon in R&D when Pfizer moved ahead with torcetrapib, a cholesterol remedy, even though safety issues had emerged in early clinical studies. Pfizer dropped the drug late last year. “This was an opportunity to bring in someone from the outside who could breathe in some fresh air,” Jami Rubin, an analyst for Morgan Stanley, tells Busyweek. “It’s disappointing.”

You can read the rest here.

Hat tip to Pharmagossip

Once again, the US Solicitor General has lined up in support of preemption, a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a controversial notion that is now making its way to the US Supreme Court.

In a related action, the Bush administration recently told the Supremes that FDA-approved medical devices are shielded from product-liability lawsuits in state courts. That position backs Medtronic in a case that has broad implications for devices makers. Unlike medical devices, however, there is no statute providing for preemption for drugs.

Nonetheless, drugmakers and the FDA argue that premption does, indeed, exist by maintaining that the agency’s actions are the final word on safety and effectiveness. The issue has become so contentious that the Supreme Court will, in fact, review a preemption case involving the Rezulin diabetes drug in February. For this reason, the Solicitor General’s brief in a case involving a Wyeth drug was widely anticipated. [UPDATE: On Dec. 28, a loyal reader pointed out that former FDA commish David Kessler and David Vladeck, a Georgetown University law professor, penned this recent essay arguing against preemption.]

In its latest opinion sent to the Supreme Court (here it is), the Solicitor General disagrees with a ruling by a lower court - in this instance, the Vermont Supreme Court - that supported a patient’s right to sue Wyeth over the labeling for Phenergan, an injectable drug. Diana Levine, a professional musician, went to the hospital for treatment of a headache and, after being injected, was left with injuries that led to the amputation of her right arm.

Read more »

One leading wag says it has. In a research note, David Risinger, a Merrill Lynch analyst who follows the pharmaceutical industry, writes that the flap over the cardiovascular risks posed by Glaxo’s diabetes pill may have swung the pendulum a bit too far. After noting a drop in scrips written this year for all oral diabetes meds, he worries aloud that diabetics and their docs may be avoiding treatment altogether.

“We believe that scrutiny of Avandia may have harmed the US diabetic population by scaring some patients off of therapy. Avandia script declines have only been partially offset by increases in other oral diabetes medications. Although a small percentage of CV events may have been avoided, we worry that a large number of diabetes patients have less control of their blood glucose levels. Unfortunately, there is no way of assessing the relative benefit of how many CV events will be avoided over time relative to the incremental diabetic complications caused by individuals dropping oral drug therapy.

“Some patients appear to have simply been scared off of drug therapy rather than switching from Avandia to alternative oral medications. This is unfortunate, given lack of glucose control among diabetics and the growing diabetes epidemic in the country,” Risinger continues. He then notes that the year-over-year growth in scrips for diabetes pills went from 2 percent to 4 percent to a decline of the same magnitude.

“Although it is ‘in vogue’ for certain thought leaders and politicians to criticize drug safety, we believe these data highlight why it is critical for FDA to remind the public that all drugs carry benefits and risks, and risks should not be over-emphasized to the detriment of patients.”

Risinger makes a fair point. But a key issue raised by the Avandia episode, among others, is the extent to which safety data is fully disclosed, analyzed and assessed by those with the responsibility for doing so, whether it be drugmakers or regulators. Having all the info on the table - and a complete understanding of the implications - should always be ‘in vogue.’

Lying on the beach? Sprawled across the couch? Maybe you’re in the office trying to catch up while things are quiet? Wherever you are, there are always interesting tales to read. Here are some we found during our own time off this week (Did we say we were on vacation?) Enjoy….

A little company in Canada is high on marijuana. Cannasat Therapeutics is testing its first product, CAT-310, which it says takes away the so-called “buzz” of marijuana that makes some terminally and chronically ill patients, particularly the elderly, uncomfortable and anxious, The Toronto Star reports. The med is aimed directly at the $4 billion neuropathic pain market that is mainly serviced by various opiates, anti-convulsants and anti-depressants. The idea is to mimic smoked cannabis through the invention of a new drug delivery technology that can be absorbed on the tongue, like a thin wafer. It doesn’t get digested by the stomach and processed by the liver before reaching the brain, so it’s similar to inhaling cannabis. So far, Cannasat has raised $9 million in seed capital. Get it?

Alzheimer’s continues to vex researchers. There are 56 drugs in some stage of the clinical trials regulated by the FDA, but few people other than their creators have great hopes they will work, The Los Angeles Times writes. Sometimes, not even the creators are optimistic, pushing whatever they have into clinical trials. Neil Buckholtz, chief of the dementias of aging branch of the National Institute on Aging, says the pharmaceutical industry has little choice. “This is basically a ‘throw the spaghetti against the wall’ strategy…We just have to try these various approaches. It’s very time consuming, very expensive, but it’s the only way we’ll know if things work or not.”

Just as pharma looks more to biotech to escape expiring patents and generic competition for chemically derived drugs, a new threat could emerge in 2008: a federal law that allows for cheaper generic copies of biotech meds, The Chicago Tribune writes. Last June, the Senate Health, Education, Labor and Pensions Committee approved a bill that would allow for biogenerics, and the House is expected to take up similar legislation in early 2008 in hearings before the House Energy and Commerce Subcommittee on Health. “Quite simply, life-saving drugs are irrelevant if they are not affordable,” says Chris Begley, ceo at Hospira, which makes hospital products and specialized medication-delivery devices that wants to create generic biotechs. “There no doubt it’s time for Congress to pass legislation enabling the FDA to create an abbreviated biogenerics-approval pathway.”

Belated holiday greetings, especially to those who encountered Santa yesterday. Officially, we are off this week, but since our e-mail is easily clogged, we thought we would stop by while conducting some housecleaning and drop off a few interesting items. See you shortly….

Researchers Hunt For Suicide Gene (The Salt Lake City Tribune)

Idera Pharmaceuticals President Resigns (Yahoo/AP)

Cohen Boosts Stake In Pharmion (The Wall Street Journal)

Celebrex Blocks Unwanted Effects Of Morphine (Reuters)

Researchers Ponder Genes That Influence Alzheimer’s (The New York Times)

Glaxo’s Alli Is Headed For The UK (The Daily Mail)

Just days after sales reps charged their employers were flouting government pricing norms, the pharmaceutical industry is pushing the government to withdraw recognition of reps as “workmen,” a classification that gives them the right to form trade unions, The Business Standard reports.

The Indian Drugs Manufacturers Association (IDMA), which represents 650 small and mid-sized drugmakers, has approached Labour Minister Oscar Fernandes to de-classify sales reps under the Sales Promotion Employees (Conditions of Service) Act of 1976. The Organization of Pharmaceutical Producers of India (OPPI), which comprises about 100 research-based multinational and Indian drugmakers, is supporting the IDMA move, the Standard writes.

“The Sales Promotion Employees Act needs to do away with the medical representatives’ classification as workmen in view of its negative effects on flexibility of business operations,” IDMA secretary general Dara Patel tells the Standard. “Considering medical representatives as workmen is an anachronism. The world over, a medical representative, by virtue of his job function, is considered part of the management team of the company.”

The move comes after the left-leaning Federation of Medical and Sales Representatives Associations of India (FMRAI) called for a centralized working rule to prevent drugmakers from ‘exploiting’ them. FMRAI has a membership of over 50,000, or a fourth of the industry’s total sales force. It is also known for its stand favoring the promotion of public sector drug units for ensuring quality meds at affordable prices.

Read more »

A Nigerian court has ordered the arrests of three of the defendants in a trial over a drug test conducted by Pfizer in 1996 which Nigerian authorities say killed 11 children and left others disabled, Reuters reports.

UPDATE: The Pfizer people are Ngozi Edozen, Pfizer’s managing director in Nigeria (pictured to the left), Larry Barry and Segun Duro, This Day reports. They are among 10 people, including Bill Steere, a Pfizer board member and former ceo, who were identified previously by Nigerian officials potentially facing criminal charges.

At issue are charges that Pfizer illegally conducted an unauthorized Trovan trial on about 200 children at a government hospital during a triple epidemic of measles, cholera and meningitis in which 12,000 people died. The episode led to the death of 11 children and various deformities - including deafness, blindness, paralysis and brain damage - in 189 others. Pfizer denies doing anything illegal and insists government permission was granted.

The Nigerian federal government is seeking $7 billion in damages and the Kano state government is seeking another $2 billion in addition to the criminal charges. Authorities in Kano blame the episode for widespread suspicion of government public health policies, helping fuel a drive by local Islamic leaders who briefly halted polio vaccination efforts in northern Nigeria, causing related infections in other countries where polio had been all-but eradicated.

UPDATE TWO: On Thursday, Pfizer reportedly says it will fight the arrest warrants.

The High Court in Kano held a hearing in the state’s criminal case against Pfizer. Lawyers for Pfizer were present but Judge Shehu Atiku complained that individual defendants should have been there and issued arrest warrants against three of them. Pfizer is arguing in a separate process in a Lagos court that the defendants were not properly served criminal summons and therefore were not technically charged or obliged to appear in court, Reuters writes.

The civil and criminal cases launched by the state and federal governments since May have developed into a tangle of unresolved petitions and side issues, dragging on from one adjournment to the next. No witness has been heard and no substantive issue tackled, Reuters reports. Atiku adjourned the Kano state criminal case to January 29 to hear a motion in which Pfizer challenges the court’s jurisdiction.

Hat tip to Pharmagossip for the first update

Bernie Poussot wanted to be ceo - now he has to earn his keep. First, he hears that Teva unexpectedly starts shipping generic versions of Wyeth’s best-selling heartburn drug (see the Protonix item below). Now, the FDA has, for the second time this year, issued an approvable letter for Viviant, which would be used to prevent bone loss in post-menopausal women.

This is a big problem for Wyeth, which hoped to combine Viviant with estrogen in a pill called Aprela, which would be used to reduce hot flashes. So, now that drug is also delayed. The drugmaker has forecast $2 billion in sales for the two drugs. This comes on top of repeated FDA decisions to postpone approval for two different versions of the Effexor antidepressant, which would be used to treat menopausal hot flashes and depression, respectively.

As far as Viviant is concerned, the FDA wants to see more analyses and discussion of the strokes and blood clots that occurred in some patients taking the med. In a statement, Wyeth says studies submitted on over the past two months show a favorable benefit-to-risk ratio, and weren’t reviewed as part of the FDA’s action. The drugmaker added that the agency hasn’t requested any new studies, but the FDA did identify “certain issues concerning data collection and reporting and requested additional source documents.”