Vaccine makers won a big victory last week when the Supreme Court ruled by a 6-2 margin that US law effectively protects them from product-liability suits based on claims of poor vaccine design.

The plaintiffs in the case were the parents of Hanna Bruesewitz, who in 1992 received a diphtheria, tetanus and pertussis (DPT) vaccine and subsequently developed a seizure disorder and multiple neurological problems.

The vaccine was made by Wyeth, which was later acquired by Pfizer. Bruesewitz will require expensive medical care for the remainder of her life.

Wyeth had denied that its DPT vaccine caused Bruesewitz’ injuries and warned that an adverse ruling by the Court would presage a flood of similar lawsuits that could threaten the supply chain for childhood vaccines. The Justice Department had supported Wyeth’s position on the matter.

In its ruling, the Supreme Court upheld a decision made by the Court of Federal Claims. In the former case, the Federal Claims court rejected the Bruesewitz’ attempt to receive compensation for medical costs associated with the care of their child. In that ruling, the court argued the parents did not prove that Wyeth’s vaccine caused their child’s injuries.

(The Federal Claims Court, a.k.a. the “vaccine court, was created by the National Childhood Vaccine Injury Act of 1986. Its adjudicates vaccine-injury claims and oversees an associated national compensation program. The vaccine court has awarded nearly $2 billion for vaccine injury claims in 2,500 cases since its inception. Its funds are derived from a tax on vaccines. The Vaccine Injury Act also protects vaccine makers from certain kinds of claims.)

In writing for the majority, Supreme Court Justice Antonin Scalia said the Vaccine Injury Act “pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.” (more…)

Last month, scientists reported that Truvada, Gilead’s once-a-day pill that is normally used to treat HIV infection, can be used to prevent HIV infection as well.

The report appeared in the New England Journal of Medicine. In the study, nearly 2,500 HIV-negative gay and bisexual men were randomized to receive either Truvada or a placebo. Study participants who received the anti-retroviral pill were 44% less likely to become HIV-positive during the 15 month follow-up than folks in the control group. The risk reduction was 73% among men who managed to take the pill every day or nearly every day.

The study results “represent a major advance in HIV research,” Kevin Fenton, the CDC’s HIV/AIDS czar told the Wall Street Journal. Even President Obama was moved to comment that the study, and those like it “could mark the beginning of a new era in HIV prevention.”

Truvada contains 2 drugs produced by Gilead: tenofovir and emtricitabine. Both drugs are reverse transcriptase inhibitors, which block replication of the AIDS virus in the human body. Normally, Truvada is combined with 2 other drugs to create a cocktail for the treatment of AIDS. This is the first time Truvada has been tested for its ability to prevent infection in the first place.

Gay and bisexual men comprise nearly half of the one million-or-so people who are HIV positive in this country. They are 44 times more likely to be HIV positive than other men.

Despite the apparently good news about Truvada, many public health officials raised concerns that people would not take the drug every day or fail to use condoms in a mistaken belief that the drug is, by itself, enough to prevent HIV infection. There were good reasons for this concern. Men in the study whose adherence to the once-a-day regimen was less than 90% experienced only a 21% reduction in infection risk.

It’s also not clear that Truvada will be similarly effective in IV-drug abusers or heterosexuals, since HIV enters the body via different routes in these people. Studies of Truvada’s prophylactic efficacy in these groups are underway.

The CDC plans to release guidelines for using Truvada to prevent HIV/AIDs in the near future. The drug hasn’t been approved for this purpose by the FDA, but physicians can prescribe drugs for off-label uses if they want.

By the way, Truvada costs just under $1,000 per month in the US. Also of note, the scientists responsible for the so-called Prep trial covered here are continuing to follow enrollees to look for drug resistance and long-term side effects. It’s something to keep in mind as the dust settles on this exciting finding.

The FDA has been on a seek and destroy mission against Web sites that distribute products it has not approved for use in the fight against H1N1.

Since May in fact, the agency has warned at least 75 Web sites to stop selling more than 135 products with fraudulent claims of efficacy against H1N1.

The FDA’s latest move in this regard has been to issue a joint warning letter, along with the FTC, to a Web site that markets fraudulent supplements claiming to help prevent spread of the virus.

The letter advises the Web site owners to cease and desist within 48 hours or else face the heavy hand of the law, which could include an injunction by the FTC and seizure of products, an injunction or criminal prosecution by the FDA.

To date, the FDA has identified all sorts of bogus H1N1 products, including:
- A shampoo claiming to protect against H1N1,
- A dietary supplement claiming to protect infants and children from H1N1,
- A supplement claiming to cure H1N1 in 4-8 hours,
- A spray claiming to leave a layer of ionic silver on one’s hands that kills the virus
- Several tests claiming to detect the virus, and
- An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said FDA Commissioner Margaret Hamburg. Such products can “make matters worse by providing consumers with a false sense of protection,” she added.

The FDA has approved 2 anti-viral drugs for treatment and prophylaxis of the 2009 H1N1: Tamiflu and Relenza.  It has also issued Emergency Use Authorizations that extend their approved labeling to additional, specific authorized uses as the pandemic spreads.

Aware of recent studies which showed that paying people to lose weight and quit smoking actually works, CIGNA and Merck have decided to launch a program that pays CIGNA beneficiaries to improve their diabetes control.

And if they happen to take Merck’s oral anti-diabetes medications during that effort, so much the better.

According to terms of the deal, CIGNA will review hemoglobin A1C results for enrollees who take oral hypoglycemic agents and if at the end of the year the values have improved, Merck will offer discounts on its entries in this field, Januvia and Janumet.

CIGNA will also review claims data for people taking the 2 drugs to determine whether they’re using them as prescribed by their physicians.

If they are, Merck will increase its discounts to CIGNA for these drugs even more.

CIGNA would then supposedly pass the savings along to its beneficiaries. 

“Merck (is) the first major pharmaceutical company to offer discounts on its oral anti-diabetic products, supporting CIGNA’s efforts to reduce A1C levels for individuals with diabetes, regardless of what medication they may be taking,” said Eric Elliott, president of CIGNA Pharmacy Management.

Januvia was approved by the FDA in 2006. Janumet made the grade in 2007. Annual sales for the two are in the $1.5 billion range, and some experts predict that number will triple in the next few years making these drugs world leaders in the growing market for oral antidiabetic therapy.

Come to think of it, why wouldn’t Merck throw tuppence at a program that hooks patients on its high-end drugs for the rest of their lives?

Yesterday afternoon, the Obama administration declared a public health emergency in response to a swine flu outbreak that has affected 20 US citizens. It is the same strain that has killed 81 people in Mexico.

Homeland Security Secretary Janet Napolitano described the move as “precautionary” and said the Feds planned to release 25% of the 50 million treatment courses of Tamiflu and Relenza it has stockpiled, just in case.

The CDC has confirmed 8 cases in New York City, 7 in California, 2 in Texas and Kansas, and 1 in Ohio. All have been mild and only one person has required hospitalization so far. 

Richard Besser, the CDC’s Acting Director said however, that he expected to see “more serious illness” this week.

Anne Schuchat, the CDC’s interim deputy director of science and health echoed that sentiment and upped it one. “I fear we will have deaths here,” she was reported to have said by MedPageToday.

The agency is trying to figure out why the virus seems to be targeting young adults, Schuchat added.  One theory is that older folks have previously been exposed to H1N1 viruses–which have contributed some to the current virus’ genetic make-up–so they’re partially immune to the new bug.

The CDC has already obtained specimens of the new pathogen from which it can develop a vaccine “if that is necessary,” said Besser. In addition, it has put vaccine manufacturers on speed dial.

Tamiflu, a pill, is made by Roche and Gilead. Relenza is inhaled. It’s produced by GlaxoSmithKline and Biota. Both drugs appear to be effective against this virus, so long as they are given quickly after symptom onset.

The Big O recently visited Mexico, but he’s shown no symptoms so he’s not been tested.

Naltrexone, a drug usually reserved for the treatment of alcohol and drug addiction, has been found to reduce the urge to steal in kleptomaniacs, according to Jon Grant and colleagues at the University of Minnesota.

Kleptomania is a rare disorder characterized by recurrent stealing. Until now, there had been no empirically validated treatments for the condition.

The scientists lured 25 kleptomaniacs to participate in an 8-week, randomized, double-blind, placebo-controlled trial of the opioid antagonist.

Subjects had spent at least an hour per week stealing things prior to enrollment.

Many had tried to control their impulses by wearing tight-fitting clothes, carrying a small purse or shopping with friends with little success.

Every 2 weeks, participants were assessed using the Yale Brown Obsessive Compulsive Scale Modified for Kleptomania and associated tools for the assessment of depression, anxiety and psychosocial functioning.

Subjects receiving naltrexone were found to have greater reductions in K-YBOCS scores, stealing urges and stealing behavior than placebo-treated subjects. 

Remarkably, nearly 2/3 of the treatment group stopped stealing altogether.

The drug “gets rid of that rush and desire (to steal)” Grant told Reuters. “These people were really troubled by their behavior.”

“Based on the fact that (kleptomania) clinically presents like an addiction, our thought was, why shouldn’t we use a medication that was approved by the FDA for addiction, to see if it can help with shoplifting?’” he told NPR.

The write-up appears in the Journal of Biological Psychiatry.

The shoplifting pill is marketed as Revia by Duramed and as Depade by Mallinckrodt.

When Pfizer acquired Wyeth after an eternity of stone cold silence in health care M & A, people got so worked-up they became tongue-tied trying to spread the news.

But then Merck bought The Plough, Roche sealed the deal with G-Tech and Gilead Sciences signed a definitive agreement to acquire CV Therapeutics and just like that, it is raining deals in Big Pharmaworld.

Gilead offered $20 per share or $1.4 billion in cash for CVT. That topped by 25% a hostile offer made 2 weeks ago by Astellas Pharma.

Gilead is best known for a trio of HIV drugs, but it’s got a dollar on darusentan which is in phase III trials for refractory hypertension. And its eyes are on CVT’s prize, which is Ranexa, a drug just recently approved as a first line agent for the management of angina pectoris. 

“The acquisition of CV Therapeutics represents a unique opportunity to complement and strengthen our growing cardiovascular portfolio,” Gilead chairman CEO John Martin said.

Last year, Ranexa did $109 million in sales. That’s a vanishingly small percentage of the market for chronic angina, a condition afflicting nearly 10 million Americans.

The FDA had approved Ranexa in 2006, but only in patients that had failed therapy with beta blockers, calcium channel blockers and nitrates, on grounds that it increased the risk of potentially life-threatening arrhythmias.

CVTs internal research had actually suggested that the drug may prevent arrhythmias, and a large randomized trial published in 2007 eventually supported the company’s view.

Safe though Ranexa may be, Gilead’s still got a major problem on its hands trying to squeeze big dollars out of Ranexa when so many different, effective angina drugs are available in generic form.

Influenza is a viral infection of the nose and throat that typically causes fever, headache, muscle aches and weakness. Sometimes pneumonia complicates the flu. The cause can be bacterial or the virus itself. In a typical season, flu mortality is well below 1%.

In 1918, an extraordinary number of flu victims developed pneumonia. Mortality ran 400% higher than usual.

In fact, “The 1918 influenza pandemic was the most devastating outbreak of infectious disease in human history, accounting for about 50 million deaths worldwide,” according Yoshihiro Kawaoka and colleagues from the University of Wisconsin and the Universities of Kobe and Tokyo.

Now these scientists think they’ve discovered what triggered the pandemic.

The team isolated genes one-by-one from the 1918 strain, substituted them into the modern flu virus and then infected ferrets, which develop flu a lot like humans do.

Time after time the ferrets developed normal flu until the scientists used a 3-gene combination called PA, PB1, and PB2 (along with a 1918 version of the nucleoprotein or NP gene).

This combination enabled the flu virus to invade the lungs, causing pneumonia and death. The team has published its findings in the Proceedings of the National Academy of Sciences.

Most experts believe there will be another flu pandemic someday. No one knows when or which strain will cause it, but the H5N1 avian influenza virus that currently circulates among birds and domestic poultry in Asia, Africa and Europe remains a likely suspect.

The current strain of Avian flu rarely infects humans but when it does, it kills. More than 60% of the 391 people infected so far have died. 

A few mutations that increase its attack rate in humans would transform H5N1 into a monster that could kill millions in months.

Before China’s market reforms of ’78 and the consequent economic growth, Liukuaizhuang was a quiet, nondescript village 100 miles from Beijing.  But the expansion was wholly unregulated and now there is a price to pay.

Liukuaizhuang is circled by dozens of chemical, paint and rubber factories, all built in the last 30 years. Every one of them has poisoned the air and water ceaselessly since the day it opened.

One in fifty residents of Liukuaizhuang has been diagnosed with cancer in the last decade. That’s 10 times higher than the national rate.

“They asked in the hospital whether my family had a history of cancer. I said: ‘No, in the last three generations no one had it’,” one villager told Reuters, while pointing to x-rays of his metastatic disease.

Local Communist Party official Huo Junwei legitimizes the concern. “The factories were not far from homes and to a certain degree influenced the normal life of the villagers,” he conceded.

“(But) we think figures provided by individuals exaggerate pollution problems in our area. For several years we have been looking into whether there is a link between cancer and chemical production and have not yet got a scientific answer.”

That whitewash aside, things got so ugly in Liukuaizhuang that government officials quietly began a pollution crackdown in 2003.

It may be too late in that, “Pollutants including heavy metals like mercury and lead have already got into the food chain,” Gao Zhong, a water pollution expert, told Reuters.

Too late for many perhaps, so aspirations naturally turn to the children and grandchildren.

“Of course I am worried, but what is the use of being worried?” said a lung cancer patient. “We have to save our concern for the next generation.”

Gulf War syndrome is legit and 175,000 US veterans of the first Gulf War suffer its effects.

That’s the conclusion of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a group of scientists and veterans appointed in 2002 by Congress to evaluate the cornucopia of neurological and other symptoms that have struck our soldiers in the years since the war.

Several earlier studies concluded that combat stress had caused the syndrome.

“Scientific evidence leaves no question that Gulf War illness is a real condition with real causes and serious consequences for affected veterans,” committee spokespeople told Reuters.

The committee added that Congress should increase research funding on Gulf War syndrome to $60 million per year.

“This is a national obligation, made especially urgent by the many years that Gulf War veterans have waited for answers and assistance,” the committee said.

The veterans that contracted Gulf War syndrome represent one quarter of all US troops that served in the effort to repel Iraq’s invasion of Kuwait. The most common symptoms include diffuse pain, memory and concentration problems, fatigue, headaches, diarrhea, skin rashes and respiratory difficulties. Few vets report that their symptoms have improved since initial onset.

“Today’s report brings to a close one of the darkest chapters of the 1991 Gulf War, and that is the legacy of Gulf War illness. For those who ever doubted that Gulf War veterans are ill, this report is definitive and exhaustive,” said Anthony Hardie, who was a 23-year-old sergeant during the war.

The panel was unable to determine what causes the syndrome, but it suggested the 2 most likely factors were pyridostigmine, a drug given to the troops to protect against nerve gas, and pesticides that were used against sand flies and other bugs during the war.