healthy4u

CRO's: we don't need Medical Informatics here

After being laid off from a major pharma as part of a large reduction in force, in recent months I've spoken to major CRO's (Clinical Research Organizations) about opportunities in Medical Informatics. CRO's are companies that conduct clinical trials for pharmas under contract as well as perform other drug development-related activities. Here are some of the responses I've received: A senior executive for Biometrics and Data Management at a large CRO with operations in my vicinity: "There's nothing in your <a href="http://home.aol.com/scotsilv/biography.htm">resume</a> of value to a clinical research organization." This was repeated even after I verbally reviewed my background with said individual. (A truly stunning and unforgettable rebuff, the likes of which I'd never heard before.) Unknown hiring manager at another large CRO (via a recruiter): "Just wanted to follow up with you about the [management] position. They sent us an e-mail today communicating that you are a great candidate but just a little too heavy on the Informatics side for this position." So, ironically, one CRO finds nothing of value in the background of a seasoned Medical Informaticist, and another finds "too much" Informatics for a management opportunity. How, one might ask, can someone be "too heavy" on the informatics side in an organization whose lifeblood is clinical data management? Here is the NIH on the value of Medical Informatics, on which they and other organizations spend tens of millions of dollars annually on <a href="http://www.amia.org/resource/acad&training/f1.html">training programs and research</a>: <blockquote>Clinical care, biomedical research and education, and public health administration can be improved by the inclusion of informaticists (in-context information specialists) into work and decision settings. Informaticists are information specialists who have received formal graduate training and practical experience that provides a cross-disciplinary background in both medical science and information science. Their cross training provides a unique perspective on the acquisition, synthesis and application of information to problem solving and program development in clinical and biomedical areas.</blockquote>Do I sense a disconnect here? This experience reflects only two CRO examples, but if this reflects the same kind of trend I've observed in the provider sector, it makes me less incredulous that the pharmaceutical industry is facing significant challenges regarding clinical trials results and post-marketing surveillance, to the point of class-action personal injury lawsuits and Congressional investigation. It may reflect a significant underutilization of talent. The reasons for an apparent blindness to Medical Informatics by providers, pharma and possibly CRO's may reflect lack of knowledge of the field, occupational jealousy or territorial issues by personnel who are unidisciplinary, or basic reactionary thinking. In any case, the repeated observations of healthcare's data management difficulties reflect a significant gap in healthcare leadership's thinking on these issues, in my opinion. -- SS

CRO's: we don't need Medical Informatics here

After being laid off from a major pharma as part of a large reduction in force, in recent months I've spoken to major CRO's (Clinica...

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Mapping your way

Mapping your way

We think maps can be useful and fun, so we've designed Google Maps to simplify how to get from point A to point B. Say you're looki...

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Get the picture

If a picture is worth a thousand words, then Google Image Search is now worth 1 trillion, 187 billion, 63 million words. Yes, that's right, math majors; we've updated our image index, and now offer users precisely 1.18763 billion newly updated images of <a href="http://images.google.com/images?hl=en&lr=&output=search&q=purple+flowers">purple flowers</a>, <a href="http://images.google.com/images?q=lamborghinis&amp;hl=en&lr=&output=search">Lamborghinis</a> and <a href="http://images.google.com/images?q=wallpapers&hl=en&lr=&rls=GGLD,GGLD:2004-06,GGLD:en&sa=N&tab=wi">whatever else you care to look at</a>. In fact, we're so excited about the quality and comprehensiveness of our updated image index, we've even begun sprinkling a few images into the regular Google.com search results for certain search terms. If you do a Google web search for, say, <a href="http://www.google.com/search?hl=en&q=sunsets">sunsets</a>, <a href="http://www.google.com/search?hl=en&lr=&q=Mount+St.+Helens&btnG=Search">Mount St. Helens</a>, or other queries for which our algorithms think pictures might be relevant results, you may see a few pictures at the top of your search results page, along with a link to complete image search results for that query. You can try out our new image index by clicking the "Images" link on Google.com, or by going directly to the <a href="http://www.google.com/imghp?hl=en&amp;tab=wi&q=">Google Image Search page</a>. Go ahead and feast your eyes. Radhika Malpani Tech Lead

Get the picture

If a picture is worth a thousand words, then Google Image Search is now worth 1 trillion, 187 billion, 63 million words. Yes, that's rig...

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Another Homicide

Another Homicide

There seems to be a tiny time-cluster of health care officials facing homicide charges, a new low for health care. (See the previous posting...

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Malpractice Crisis in Ireland: Physicians to Vote On Industrial Action

Although this blog has had a distinctly American flavor, we believe that the general problems we discuss know no national boundaries. (By the way, we'd be happy to welcome some bloggers from outside the US.) For example, those who think that the malpractice insurance situation is bad in the US should see stories <a href="http://www.limerickpost.ie/dailynews.elive?id=6021&category=Daily-Mon">here</a> and <a href="http://www.ireland.com/newspaper/front/2005/0207/2362756787HM1HEALTH.html">here</a> from Ireland. Although Ireland has a national health service, Irish hospital-based physicians (consultants) still face the risk of malpractice law-suits. Now Irish hospital consultants are ready to vote for an "industrial action," i.e., a doctor's strike, over malpractice insurance issues. Apparently, the Irish government developed a new system of malpractice coverage, but which did not include coverage for liabilities incurred before last February. The former source of many physicians' coverage of this "tail" (in the US parlance), is no longer available. So physicians have no source, other than own pocket, of payment for expenses occured to defend lawsuits arising from events before last February, and no insurance for any damages they might have to pay.

Malpractice Crisis in Ireland: Physicians to Vote On Industrial Action

Although this blog has had a distinctly American flavor, we believe that the general problems we discuss know no national boundaries. (By th...

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CVS tied to R.I. lawmakers

I am aware that Rhode Island has had its share of healthcare problems in the insurance sector. Here's another angle to the dangers of allowing those involved making a living from healthcare parasitically to curry favor from those who set or enforce the rules for society (i.e., politicians, also usually with no healthcare credentials). I am the son of a small, independent pharmacist in Philadelphia who opened his first store in the early 1950's. I worked for my father as a teen and literally watched the takeover of his profession by large corporate interests as chain drugstores started dotting the landscape, including directly across the street from his venerable <a href="http://home.aol.com/ku3e/lumar.jpg">Lumar Pharmacy</a>, Somerton (far Northeast Philadelphia). -- SS CVS tied to R.I. lawmakers The drugstore chain's dealings led to the state Senate president's resignation. By Michael Mello, Associated Press PROVIDENCE, R.I. - From the University of Rhode Island's sparkling Ryan Center, named after CVS Corp.'s top executive, to the familiar red signs that dot the landscape, the nation's second-largest drugstore chain is a clear economic force in the nation's smallest state. Yet CVS's behind-the-scenes political clout may be even stronger. A furor has erupted at the Statehouse over the recent disclosure that CVS - Rhode Island's largest private employer - had secret business dealings with some lawmakers. The uproar has spurred the resignation of the state Senate president and led to an investigation by the Rhode Island attorney general - himself a former CVS lobbyist. Activist groups are demanding tighter disclosure laws. Others want to replace the state's part-time legislature with a full-time one, so that lawmakers are less likely to hold down outside jobs that could create conflicts of interest. Republican Gov. Don Carcieri, meanwhile, wants a special commission to investigate corporate influence in government. "We have a huge crisis of confidence in the public's mind," he said last week. The governor's concern goes beyond CVS to recent ethics complaints involving other firms, including Blue Cross & Blue Shield of Rhode Island, the state's largest insurer. Also, two executives connected to the Lincoln Park dog track and gambling hall have been indicted on charges of conspiring to pay a bribe of up to $4.5 million to the House speaker's law firm in 2000 and 2001 for help in winning approval for more video slot machines and blocking a proposed casino. Rep. John Harwood, who is no longer speaker, has denied any wrongdoing and has not been charged. Few, if any, companies are as tightly woven into the fabric of the state as CVS. Cofounded by Woonsocket native Stanley Goldstein, CVS opened its first store in 1963 in Lowell, Mass. The Fortune 100 company now has about 4,200 stores in 32 states and the District of Columbia. It has dozens of stores in the Philadelphia area. Its corporate headquarters are in Woonsocket, and it employs about 5,200 people in Rhode Island. CVS has long been lauded for its philanthropic efforts, including an annual charity golf tournament. The company and its chief executive officer, Tom Ryan, donated at least $4 million to help build the state university's sports arena. But critics say the goodwill generated by the company's good citizenship has been erased by the secret business relationships with Democratic Senate President William Irons and Sen. John Celona, who was chairman of a committee overseeing the health-care industry. "I can't trust them," Democratic State Sen. Leonidas Raptakis said of CVS. "Why didn't they come out and tell the public of this hidden agenda?" Irons, an insurance broker, received $70,000 in commissions over two years as the broker on a CVS employee health-insurance policy, according to federal documents. And Celona acknowledged he was being paid $1,000 a month by CVS as a consultant when a bill opposed by CVS died in his committee. The bill would have relaxed the exclusive relationship Blue Cross has with CVS and certain other pharmacies, and allowed patients to get their prescriptions filled at drugstores including Walgreens. Celona has since stepped down from the chairmanship, and CVS's competitors are again pushing the bill. CVS said in a statement that it violated no state laws but is adopting new procedures that "will hold CVS to a higher standard of conduct than that required by Rhode Island state law or regulation." Some of the financial arrangements were brought to light by the Providence Journal. Because Rhode Island lawmakers are part-time, they are not barred from working for CVS or any other company. Lawmakers must report the names of their employers, though not the exact amounts they are paid. Celona and Irons could be fined for not disclosing their business relationships. Criminal investigators are looking deeper, to see if businesses have bought influence with lawmakers. Celona and Irons both declined interview requests. Rhode Island Attorney General Patrick Lynch is heading the investigation along with state police. He has resisted calls to remove himself and appoint a special prosecutor because of his own past connections to CVS. CVS also is named in an ethics complaint against Republican State Rep. William McManus, a business analyst for the company. McManus is accused of improperly speaking against a bill to allow the sale of medications imported from Canada. The Rhode Island legislature typically meets six months a year in the late afternoons, and includes teachers, lawyers, restaurant owners, firefighters, insurance agents and farmers. Most of the lawmakers make $12,063 a year. Democratic Sen. Joseph Polisena said Rhode Island needed a full-time legislature. "As we have seen in a number of instances, there can be unfortunate results when members of the part-time General Assembly serve two masters - the citizens in their districts and their regular, full-time jobs," he said. But having full-time legislatures can lead to complaints, too - namely, that the lawmakers are too focused on reelection. "If it is their primary source of income, then it becomes a job that's important for them to hold onto, then they'll make decisions in the interest of getting reelected," said Karl Kurtz of the National Conference of State Legislatures.

CVS tied to R.I. lawmakers

I am aware that Rhode Island has had its share of healthcare problems in the insurance sector. Here's another angle to the dangers of al...

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"There is Always a Hidden Agenda" - Alleged Cover Up of Research Abuses at the VA

In January, we <a href="http://hcrenewal.blogspot.com/2005/01/those-government-health-care-blues.html">posted the story </a>of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, <a href="http://www.nytimes.com/2005/02/06/nyregion/06vets.html?hp&ex=1107752400&amp;en=1f9bb82504a0e363&ei=5094&partner=homepage">the NY Times published a major piece of investigative reporting </a>on the affair, which now appears to be larger and more troubling than it did last month. Then, the focus was on research coordinator Paul Kornak. Kornak was apparently hired despite having lost medical licenses in several states due to forged credentials, and a felony fraud conviction in Pennsylvania. Although Kornak apparently never completed medical training, the Stratton VAMC allowed him to perform physical examinations and identify himself as "doctor." The FDA found that Kornak had falsified patients' medical records in several drug studies, allowing patients to enroll in studies even though they should have been excluded. Kornak plead guilty to fraud and negligent homicide for the death of one patient in a chemotherapy study. However, problems at Stratton predated Kornak's arrival. In the 1990's, two pharmacists repeatedly complained of major violations of research protocols, including enrollment of patients without consent, enrollment of patients who should have been excluded, and giving patients treatments not included in protocols. In response, the pharmacists were targeted by VA internal investigations, although none ever found any wrong-doing. An investigation of research at the hospital, conducted by Dr. Thomass Ferro, was allegedly rigged by administrators to find nothing wrong. Said Dr. Ferro, "there is always a hidden agenda to exonerate or convict in these internal investigations. In this case it was to exonerate." So Ferro did a cursory investigation, and even after he then "watered down" his finidings, his superiors edited his report to remove even "minor discrepancies." Furthermore, how the VA responded on the national level to the problems at Stratton was even more troubling. When problems there first were noticed in 2003, the new VA Chief of Research and Development, Dr. Nelda Wray, ordered a nation-wide review of VA research. She halted research altogether at Fargo, ND, where there were problems with the Institutional Review Board. She ordered credentials checks on and ethics training for all researchers. But by2004, Dr. Wray, in turn was accused of ethics problems, and was <a href="http://www.biomedcentral.com/news/20040326/03">forced out of her position</a>. Her lawyer charged the investigation was "an easy and convenient way to stop sorely needed reforms." Some major points: - The response of the VA to staff complaints about research at the Stratton VAMC was apparently to punish the whistle-blowers, and cover up the complaints. This is all too reminiscent of the cases of physicians punished for complaining about quality, detailed in the landmark investigative series in the Pittsburgh Post-Gazette, <a href="http://www.post-gazette.com/pg/03299/234499.stm">The Cost of Courage</a>. - This response allowed wrong-doing to continue, resulting in, according to a court of law, the death of at least one patient. - Thus, this case suggests how bad leadership of a medical organization can not only harm the research process, or suppress research results, but also directly harm patients. - Furthermore, the allegations made by Dr. Wray's lawyers, if true, suggest that the problems go much deeper, or higher than the administration of one VA hospital. Coupled with all the other stories we have been reporting, about not only the VA, but the NIH and the FDA at the federal level, about numerous for-profit companies, and not-for-profit hospitals and managed care organizations, this underscores how we need to get serious about restoring integrity to the leadership of health care organizations.

"There is Always a Hidden Agenda" - Alleged Cover Up of Research Abuses at the VA

In January, we posted the story of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, the NY Times published...

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