Law And More

Follow the Money: More than half of academic research faculty have ties to drug/device industry

Science is, well, a businesss.  And those faculty who toil in the vineyards of academic research are no strangers to that business side. 

In THE WALL STREET JOURNAL, Jacob Goldstein reports that 53% of them had financial ties to the drug and device industry. [Jones Day partner Mark Herrmann has a useful blog on legal matters in that industry.] Goldstein got his information from the 2006-07 survey that was published in HEALTH AFFAIRS this week.

Those ties included consulting work, paid speaking engagements, and research funding.  The percentage of those receiving funding for research is down from what was reported in 1995.  It's now 20% versus 28% back then.  The causes, notes Goldstein, could be in the increase in NIH research funding and the greater scrutiny of ties of university faculty with industry.

For some purists, any tie is too close of a tie between research and commerce.

E-Coli Kills Two: Is it the ground beef?

The meat industry, government, and retailers don't seem to have the safety of ground beef down cold.  They did for several years following the Jack-in-the-Box E-Coli deaths in the early 1990s.  As Bill Marler of Marler Clark Law Firm, which specializes in food-borne diseases, frequently testifies to Congress, systemic reforms were made Download Testimonywaxmanfoodsafety.  Both the leadership in the government and public will were there to ensure that happened.

Experts in the field of food safety still don't understand the factors, probably interrelated, which undid that fix.  But it was undone.  The latest The Horror is that two have died from an E-Coli in the northeast.  It may have been from ground beef. Fairbank Farms, which produces the meat, has issued a voluntary recall for 545,699 pounds.  Here is what Marler has blogged on the outbreak.  You can connect with his blog for updates here.

Off-label pediatric antipsychotics can trigger rapid weight gain, metabolic changes

More possible bad news for BigPharma, particularly companies like Eli Lilly who sell antipsychotics like Zyprexa to those 4 to 19 years of age. Some of the prescriptions have been off-label applications such as for attention-deficit disorder. 

A study in the JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, reports Duff Wilson in THE NEW YORK TIMES, has a study about the side effects.  They can include rapid weight gain [1 to 1-1/2 pounds a week] as well as metabolic changes.  The latter could lead to high blood pressure and diabetes.

One interesting finding was that the four drugs investigated had different levels of side effects.  Zyprexa had the most severe.

Prediction:  Lawsuits demanding that those who took these medications be reimbursed for lifelong monitoring of obesity and other diseases - just as with lead paint.  In addition, BigPharma and medical doctors will be put on a much shorter leash when the prescription is for children.

Sodium Azide - Time for Bill Marler to Hit the Coffee

It's now official.  It was sodium azide in single-serve cups of coffee from a vending machine outside a pathology lab which poisoned six Harvard Medical School employees last August.  All recovered quickly, reports Jennifer Levitz in THE WALL STREET JOURNAL.

This could be one for Bill Marler of Marler Clark Law Firm, which specializes in food-borne diseases.  How did the chemical, used as a preservative in laboratories, enter the coffee?  Can its properties be passed along by some kind of osmosis?  Was the vending machine sabotaged?  Was the contents of the vending machine supplied negligently by the coffee vendor? 

Of course, we are now completely freaked about obtaining products from vending machines which aren't pre-sealed.  In my complex there is such a coffee/soup/hot chocolate machine.  Won't catch me putting in my dimes any more.

"I just lost it," Derrick Praileau, accused of strangling/stabbing hotel guest

What neurological processes go awry when someone claims to "lose it?"  This is a question for science and the answer is needed in our legal system as well as the management of the workplace. 

In NEW YORK Magazine, Jessica Pressler reports that employee at the Essex House Derrick Prileau claims, "I just lost it."  He was arrested last Saturday for strangling and stabbing a guest at the hotel. He has confessed.  

Here in New Haven, Connecticut, some contend that Raymond Clark III, accused of murdering Yale co-worker Annie Le, might have "lost it."  A lover of animals, he is said to allegedly had issues with how the researcher was handling the mice she was studying.

A few miles from Yale, a driver yelled at me to cross the street faster.  One or both of us could have "lost it."  We could have both been on court dockets right now. What was going on? What, including medication, could prevent it?  If we anticipate a day we might "lose it," should we be popping Med X?

Slaying of Women on University Campuses

This is the second slaying of a female on or near the Yale campus.  And this syndrome is one that, as a public service, has to be probed by the brilliant minds of those fictional sleuths we trust such as Dr. Spencer Reed.

The police have not confirmed officially that the body found is that of graduate student Annie Le.  But that seems a mere formality.  Yale students will be holding a candlelight service in Le's memory.  There's more to this pattern of killing females in academia than a grudge, fantasy, jealousy by a professor, lover, would-be lover, marginal hanger-on around campuses, or delusional staff employee. 

The police are speculating this murder was not a random act.  Then why does it happen at all and why did a murderer ring twice at Yale in New Haven, Connecticut?  And, more importantly, how can it be prevented. 

We don't shelter females getting an education the way the powers-that-be did when I was in college.  At Seton Hill in Greensburg, Pennsylvania in the 1960s, we young women were kept on a short leash.  At the time I cynically assumed it was to ensure no tampering with our virginity which could have made us Roman Catholic women less marketable in the marriage game.  Now I know:  It was to save our lives.  Maybe that kind of realistic understanding of the perils of the world should be honored in establishing campus policies and practices for women.  Females will no longer have to die to become educated.

Note:  Last month I was mugged in New Haven.  No male had been in that same neighborhood.  I learned plenty about the unique vulnerability of being female.  

Medical/Scientific Ghostwriting - No Different than "assisting author" in business/politics

If medicine and science weren't taking it in the chin currently, we probably wouldn't be having this THE HORROR about ghostwritten articles.  It's now known, reports Duff Wilson in THE NEW YORK TIMES, that ghostwriters are used for articles published in prestigious journals and the industry doing the paying includes beleaguered BigPharma.

Ghostwriting is an accepted practice in business as well as politics.  The thinking goes that it is an inefficient use of an executive's or leader's time to actually pen a book, article, opinion-editorial, blog, or tweet.  The rates for a book can range from about $8K to $100K.  The organization such as a corporation, political action committee, publishing house or the author whose name appears on the book usually funds the project. 

Since 1979, when I was hired by Gulf Oil, now Chevron, I have been employed full-time or as a consultant in ghostwriting and speechwriting.  The lion's share of the assignments are now for digital content.  Any ethical qualms?  Never had them.  Probably never will.  Incidentally, if the medical and scientific powers-that-be in publishing have appropriate work I can do for them, they can reach me at Mgenova981@aol.com, 203-468-8579.  Emergencies welcome.  Fees negotiable.

Childhood lead poisoning getting official attention in China, or so powers-that-be claim

The science is all there.  We know how to prevent, diagnose and treat elevated levels of lead in the blood of children.  In fact, in the U.S. that has been declared one of the major public-health success stories.  Attempts at lawsuits against the paint companies which had produced lead paint when it was legal have been failing.

In China, the science has long been ignored.  The litigation system remains in the hands of the government.  Regulations are not usually enforced. Overall, profits have taken the attention away from the massive problem of lead poisoning among children there. 

Among the causes are parents who drag in lead into the home from their jobs in manufacturing and the operation of smelting plants near where children live.  At last, reports  Sky Canaves in THE WALL STREET JOURNAL, the powers-that-be in China are taking action - or claiming they are.  They have stated that measures are being put in-place.  However, the details have not been disclosed. The response seems to be triggered by grassroots protests after testing revealed 1000s of children have been classified as "lead poisoned."

But this will be a tough nut to crack since lead is such a profit center for China.  As Canaves notes, the country is the global top producer of lead.

Harvard Medical School Should Have Checked This Out With Harvard Law School

It was as if George Orwell had never exposed a regime's attempt to position war as peace.  Or that the current generation of the best and brightest hadn't read "1984" back in high school.

Harvard Medical School had enacted a policy restricting students from talking with the media.  The reason, reports Duff Wilson in THE NEW YORK TIMES, was to "help" them.  According to HMS's Dean of Students Dr. Nancy E. Oriol, " ... the policy was intended to help students, rather than limit speech or control what they say on controversial topics."  Mmmmm.  Well, the students et al. didn't buy that and pushed back.  HMS, says Wilson, "is backing off."

There's more.  Dr. Oriol noted that the policy being re-thought "applies to 'the media' rather than new media like Twitter."  Had Dr. Oriol coached former President Bill Clinton's analysis of the term "is."

This could be another hit to Brand Harvard.  It has been taking plenty of those dating back to when Larry Summers was its President and more recently to when the geniuses managing its endowment lost $16 billion and agreed to a loan with annual interest of hundreds of thousands of dollars a year.

Recommendation: HMS run new policy proposals by Harvard Law School.

The FDA - Could Conflict of Interest Allegation Blow?

 At the Federal Food and Drug Administration, a top career official is being investigated for an alleged conflict of interest in handling of an approval of a generic medication. 

If this allegation turns out to have any validity, the scandal could blow the FDA and trust in any government agency or regulatory entity into a million pieces.  In addition, both BigPharma and biotech could be thrown into disarray.

In THE WALL STREET JOURNAL, Alicia Mundy reports that Janet Woodcock, the FDA's Director of the Center for Drug Evaluation and Research, is being investigated by the Department of Health and Human Services's Investigator General.  The conflict of interest complaint has been filed by Amphastar Pharmaceuticals Inc. 

Amphastar contends, explains Mundy, that "it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner ... its competitor [Momenta Pharmaceuticals Inc.] had special access to Dr. Woodcock at critical times" during that process.

That perception stems in part from collaboration between Woodstock and Momenta on a scientific paper at the time that both companies were seeking approval.  Mundy notes that it is "unusual" for an FDA official to jointly publish an article in a journal with scientists from the pharmaceutical industry.   Moreover, this incident occurred right in the midst of a drug approval process.

The FDA has not made Woodstock available to comment on this to the media.

Issue:  Shouldn't a seasoned FDA official have understood what could and probably would be perceived as a potential conflict of interest?