24 Nov – Efforts to make hospitals safer for patients are falling short, researchers report in the first large study in a decade to analyze harm from medical care and to track it over time. The study, conducted from 2002 to 2007 in 10 North Carolina hospitals, found that harm to patients was common and that the number of incidents did not decrease over time. Continue reading ‘Study Finds No Progress in Safety at Hospitals’
Archive for the 'Reform' Category
May 21 Wash DC: Next week, the Government Accountability Project (GAP) will host the 2010 Whistleblower Assembly in Washington DC. According to their latest release, the event is co-sponsored by Semmelweis Society International (SSI) – this despite receiving proof that their alleged connection to SSI is a pharmaceutically-funded fraud. Continue reading ‘Corruption Threatens DC Whistleblowers’
PASO ROBLES, CA – At a time when ObamaCare threatens Americans and their progeny with unbearable healthcare costs, a company called Medibid may do for healthcare consumers what StubHub, PriceLine and eBay have done for consumers. By linking patients to doctors who Continue reading ‘MediBid: The Travelocity of Healthcare?’
In another case of doctors selling out to the pharmaceutical industry, the Guardian reports that Dr Richard Eastell is being tried in front of a medical council for allowing his name to be put on a study of the osteoporosis drug Actonel.
Doctors have been agreeing to be named as authors on studies written by employees of the pharmaceutical industry, giving greater credibility to medical research, according to new evidence.
The Guardian has learned that one of Britain’s leading bone specialists is facing disciplinary action over accusations that he was involved in “ghost writing”.
The wider phenomenon has come to light through documents disclosed in the US courts which have revealed a culture in which doctors agree to “author” studies written by employees of drug firms. The doctors may have some input but do not have access to all the evidence from the drug trial on which the paper’s conclusions are based, the documents showed.
The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study’s conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.
Experts believe the practice is widespread in Britain. In another alleged example, a consultant cardiologist claims an expert listed as an author on a medical paper died before the research began. Peter Wilmshurst, a heart specialist at the Royal Shrewsbury hospital, is involved in a dispute over a study which he helped design, which involved the insertion of a device to close a hole in the heart.
He claims the manufacturers refused him access to data and he had concerns about the accuracy of the paper, so he refused to sign it off and is not listed as an author. One of those who is named, Wilmshurst said, is a true ghost author. Anthony Rickards, a cardiologist, was involved in preliminary discussions but died before the research was conducted.
The company which sponsored the research, the US firm NMT Medical, is suing Wilmshurst for remarks in a lecture that he made about outcomes in the trial, which were published on a medical journal website. A UK charity, HealthWatch, has launched a fund to support Wilmshurst, who was in 2003 a recipient of its award for challenging misconduct in academic medical research.
The US documents show that Wyeth, one of the biggest companies involved, employed a medical writing agency with the purpose of getting favourable studies about its HRT drug Prempro into prestigious medical journals.
The agency dreamed up ideas for papers about the benefits of the drugs and then wrote an outline and even a first draft before offering it to a doctor who might agree to have his name attached as the author. Although the doctor would see drafts and revisions, critics say that control of the content and message were in the agency’s hands. The memos and emails show that many busy academics signed their approval to the finished paper.
Many of the documents are records of planning meetings, where agency staff list articles that will be written, suggesting possible authors and targeting journals. Concern about ghostwriting caused the UK-based open-access journal PloS Medicine, part of the Public Library of Science, to intervene in a court case brought by women who claim they were harmed by the HRT drug. PloS Medicine, with the New York Times, argued that the public should know what was going on. A US judge agreed to place the documents in the public domain.
Ginny Barbour, editor in chief of PloS Medicine, said she was taken aback by the systematic approach of the agency. “I found these documents quite shocking,” she said. “They lay out in a very methodical and detailed way how publication was planned. “Other documents released through US court action show that GlaxoSmithKline employed a ghostwriting programme named Caspper in which doctors could take credit for medical journal articles written by the company’s consultants.
The project was aimed at boosting the US sales of an antidepressant called paroxetine, which goes by the brand name Paxil in the US and Seroxat in the UK.
Caspper stood for Case Study Publication for Peer Review. It enabled doctors with positive experiences of Paxil to get into medical journals. A busy doctor could sit back and let a medical writing agency paid by GSK do all their work, from the first draft to getting it accepted for publication by a journal.
The medical writing agency would prepare drafts using whatever material the doctor sent them and create figures and tables. These would go to the doctor for approval. “The author ensures accuracy of material, updates references, supplies missing information, etc,” says the leaflet. Eventually the doctor would complete a sign-off form and the agency would send the paper for publication.
Caspper came to light when internal GlaxoSmithKline documents were released in court action in the US brought by the legal firm Baum Hedlund on behalf of patients who claim they were harmed by Paxil. GSK says the programme was discontinued some years ago and that the names of medical writers were included on any published papers.
But Caspper shows there was no dividing line at the time between science and marketing – the leaflet states its purpose is to “strengthen the product positioning and overcome competitive issues”. Doctors and medical journals became part of a promotional campaign, aimed at selling more drugs.
The disciplinary move in the Eastell case comes after he admitted that a statement he signed declaring that all six authors had access to all the statistical data was wrong.
In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: “In the original paper one of the authors, a statistician working for P & G, Ian Barton, had full access to all the data.” The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.
The letter, published in 2007, also acknowledged flaws in the study. A later ndependent analysis of the data “identified some errors and poor practice”, he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.
Eastell’s paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.
Eastell’s colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped, Eastell said he was concerned that persistent requests might damage the
relationship they had with the company. Eastell is said to have told him: “The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.” .Tim Kendall, joint director of the National Collaborating Centre for Mental Health, says the problem is the close relationship between doctors and the industry. “Some doctors don’t seem to see the relationship … as problematic.”
A study of 4,000 physicians found that 96% received money from drug companies, and yet “the majority did not see it as a conflict of interest”, he said.
“I do think there needs to be a national debate in this country about the interpenetration of medicine and the pharmaceutical industry.”
Ghost writing was one manifestation of a bigger problem which he believed was the institutional bias of doctors who work closely with and for drug companies. “In mental health 85% of all published trials are funded by the drug industry,” he said. Allowing for the unsuccessful trials the industry does not publish, the figure is probably nearer 95%, he said.
Studies have shown that drug company-funded trials are five times more likely to come out with a positive result for the drug than independent trials.
The GMC is criticised by doctors like Wilmshurst and Blumsohn for failing to take a tougher line against doctors involved in dubious research practices.
Jane O’Brien, head of standards and ethics, said that their research guidance specified the importance of honesty in the attribution of authorship. “We would see that as an important issue. If somebody’s name is on something it gives research a credibility that it wouldn’t otherwise have. If somebody had not been involved, we would see that as misleading people as to the credibility of the research.”
She added that the GMC felt it important to play a role in ensuring good conduct in research. About a year ago, she said, they took soundings of bodies that regulate and support research, such as the Medical Research Council, asking whether the GMC should be involved. “The response was yes, because we are the people who can strike doctors off in the end.”
Eastell declined to discuss the hearing. “I do not wish to comment on the case. The proceedings have yet to commence,” he told the Guardian in an email. A spokesperson from the University of Sheffield, where Eastell is professor of bone metabolism, said they were aware of the investigation. “We will be informed by the GMC of any outcome and cannot comment further until we receive this.”
I learned a lot about the cost of health care when I had a hybrid general surgery practice in California ‘s rural San Joaquin Valley. My practice consisted of uninsured women with breast cancer combined with a smaller percentage of cosmetic patients whose cash payments for “vanity care” subsidized the treatment of women unable to pay for needed medical treatment.
Although patients seeking cosmetic services tend to be healthy, I evaluated them like any other patient. I asked about medical history, allergies, medications and genetic disorders.
Upon questioning Sherry S., a pretty 46-year-old seeking wrinkle relief, I learned that four of her immediate family members had been diagnosed with breast or colon cancer before the age of 50. Alarmed, I asked why she had not had the recommended screening mammogram for more than four years.
She said that she knew already that her risk for developing breast cancer was likely higher than that of most women.
“But I don’t have insurance,” she replied.
A screening mammogram could be obtained for about $90 and was discounted or free at local facilities every October for “Breast Cancer Awareness Month.”
She smiled when I proposed a deal: if she were to get a screening mammogram within sixty days of her treatment, I would offer a discount on what she paid me for cosmetic services.
“I’ll think about it,” she said, then shelled out over $400 for BotoxTM injections that took me ten minutes to administer.
Five months later, when she returned for her next wrinkle treatment, she reported that she still had not obtained a mammogram.
I encountered patients who gladly paid upwards of $1000 in cash for laser hair removal treatments. The paperwork filled out during their initial consultation asked them to indicate whether or not they had health insurance.
Several hair removal patients reported being covered by Medi-Cal, the government funded health coverage for California ‘s low-income population.
A friend of mine sells private health insurance plans. He told me of the 39-year-old father of two whose family was quoted a monthly insurance premium of $250.
Several hair removal patients reported being covered by Medi-Cal, the government funded health coverage for California ‘s low-income population.
A friend of mine sells private health insurance plans. He told me of the 39-year-old father of two whose family was quoted a monthly insurance premium of $250.
“Are you kidding?” he said, refusing the coverage. “That’s almost as much as my boat payment!”
When serving in the Rural Health Center in my community, my colleagues and I offered free or discounted care for a large number of patients. Many were covered by Medi-Cal or one of dozens of state programs paid for by the taxpayers of California.
The following items were commonly seen on patients or carried by their dependent children, who were also covered by subsidized programs:
• Cell phones and “BlackBerry” PDAs, including just-released models with a price tag of $400, plus an ongoing monthly service fee of $65-$150
• iPods and portable DVD players
• GameBoys and handheld electronic games
• Artificial fingernails requiring maintenance every two weeks at a cost of $40-$60 per salon visit
• Elaborate braided hair weaves, $300 per session plus frequent maintenance
• Custom-designed body art, including tattoos covering the entire torso, neck and arms, as well as body jewelry piercing every skin surface imaginable-and a few unimaginable ones. Custom tattoo work, particularly the “portrait-type” and “half sleeve” art popular in this area, runs from $100-$300 per hour and can require up to 20 hours of work, depending on the complexity of the design.
[Author's note: in three years, I performed over a dozen operations as the result of complications related to infected or abnormally healed body piercings. Breast abscesses were the most common pathology, followed by cauliflower-shaped keloid scars that interfered with function. Blood-borne diseases can be contracted during amateur and prison tattoos and piercings, and patients self-reported Hepatitis B, Hepatitis C and HIV infections. Treatment of the complications of body art among my patients was largely covered by Medi-Cal or left unpaid.]
From the office I shared with another doctor at the clinic, I had a clear view of the patient parking lot. It was not unusual for me to see clinic patients drive away in late model SUVs or cars customized in the style popular in my area. I was given an education about the after-market accessories I saw daily, including “mag” wheels, chrome trim, spinning hubcaps and fancy custom paint jobs. Gasoline prices were particularly high in central California at that time.
From the office I shared with another doctor at the clinic, I had a clear view of the patient parking lot. It was not unusual for me to see clinic patients drive away in late model SUVs or cars customized in the style popular in my area. I was given an education about the after-market accessories I saw daily, including “mag” wheels, chrome trim, spinning hubcaps and fancy custom paint jobs. Gasoline prices were particularly high in central California at that time.
I overheard patients and their children chatting as I wrote in their charts. Many had an excellent command of the plotlines of cable television shows aired only on premium channels. Basic cable in my area cost over $50 per month, with premium channels extra.
I also overheard the front desk clinic staff members explain politely to angry patients that they did, in fact, have to make $5 co-pays for an office visit or meet their $20 “Share of Cost” on a $600 bill as required by Medi-Cal.
Like many of my colleagues in rural communities with few resources, I did care for patients who actually lived in poverty. For them, luxury meant keeping the utilities on and having clean clothes for a rare visit to the doctor. In California ‘s Central Valley , “dirt poor” is not just a phrase. But these patients, who rewarded me in ways that don’t fit in the lines on any tax return, were outnumbered by others who considered health care a lower budget priority than decorated skin and expensive toys.
Individuals in this country have a right to decide how — and how not — to spend their money.
But that right does not include accepting entitlements without sharing responsibility. Doing so contributes to the high cost of care that burdens every unsubsidized patient.
If individuals prefer to buy luxury items rather than pay for their healthcare needs, that preference should not be rewarded while taxpayers struggle to foot their own bills.
Dr. Linda Halderman was a Breast Cancer Surgeon in rural central California until unsustainable Medicaid payment practices contributed to her practice’s closure. She now serves as the healthcare policy advisor for California’s Senator Sam Aanestad while continuing to provide trauma and emergency services in rural communities. www.americanthinker.com
Clifford Asness debunks many healthcare mythologies and explains why they exist in this report:
Lots of people are scared and misinformed by their politicians and the media or else they would understand the whitewash that is going on here and reject socialist “solutions” to a problem best solved for their families by freedom…
The rush to pass a huge expansion of government now, and limit debate and discussion, is indicative of a group that knows it is wrong, and if people have time to think they will refuse to go along, but is attempting an exercise of naked power, to impose dictatorship before the people wake up.
Actually the media is often just plain intellectually lazy, repeating tired leftist dogmas and looking down on anyone who believes in freedom as just a red state moron (trust me, they think that). How else do you explain free infomercials for Obama’s socialized medicine without rebuttal?
Some politicians may indeed just be idealistic dupes who actually want to help people but don’t realize they will harm them. I have sympathy for these people but they still should not win the day. Some just want to feel important. But let’s leave Ms. Pelosi out of this for now. Let’s talk about the smart ones who understand these issues. I do not think true confusion among the political and intellectual class is most of their problem. I do not think they believe for a second that socialized medicine will make people better off. How could they?
Lots of politicians understand that the simple free system leaves them out in the cold. No power for them. No committees to sit on to decide people’s lives. No lies to tell their constituents how they (the government) brought them the health care they so desperately need. No fat checks from lobbyists as the crony capitalists pay dearly to make the only profits possible under this system, those bestowed by the government.
Libertarians are often accused wrongly of loving “big business,” but we don’t, particularly when corporate executives predictably turn themselves into crony capitalists who try to succeed by wheedling from the government. On the other hand the socialists love cronies of all sorts, ones who command large enterprises all the better. Liberals are far closer than libertarians to building and countenancing the all-powerful corporate state they claim to fear.
Odd I know!
That an array of crony capitalists are lining up from Wal-Mart to hospitals to medical insurers (bringing back Harry and Louise – this time for socialism) hoping to cut the best deals for themselves before the iron curtain falls is sad. That they are being lauded by the administration as a sign its health care position is right is simply propaganda. Yep, when someone agrees to pay Al Capone protection, it’s a clear sign Al Capone was right to begin with….
We further see this predicted abuse of power as the health care proposals are already filled with freebies to the President’s friends – including exempting unions from onerous features. Gee, the same unions in whose favor he has re-written the bankruptcy rules and wants to exempt from the most American of ideas, the secret ballot. It’s good to be a friend of “the most ethical administration ever.”
For another example how this is about government power and the suppression of private liberty, and not about helping people, look no further than the fact that their proposed massive tax increase on the “rich” (which by leftist definition are never paying their “fair share” if they have enough left over to remain rich) is on pre-deduction income.
That means if you give all your money to charity you still owe Caesar his 5+ percent on money you did not keep and do not have, but gave away to a good cause. This might raise some revenue, but it is largely about the destruction of private charity. Barack and Harry and Charlie and Nancy and the other gang of four (yes our gang of four is much bigger than four) are about the people having to crawl on their knees to government (them) instead of anyone else, including private charity, not about helping people.
BTW, Congressman Rangel, the House’s chief tax writer and current tax cheat investigatee, said lawmakers targeted high earners because it “causes the least amount of pain on the least amount of people.” So does, in the short-run, imprisoning the rich and harvesting their organs for better health care for everyone else. Charlie, any thoughts on where you stop? When is enough enough?
The rush to pass a huge expansion of government now, and limit debate and discussion, is indicative of a group that knows it is wrong, and if people have time to think they will refuse to go along, but is attempting an exercise of naked power, to impose dictatorship before the people wake up.
Paraphrasing Mark Twain, a lie can travel halfway around the world while the truth is putting on its shoes. They are counting on this, and they don’t want to give the truth time to be shod. (More here)
California surgeon Linda Halderman reports that Congress’ version of ObamaCare will feed the federal deficit and “cause small businesses to hemorrhage and carve a pound of flesh from patients forced to navigate the new bureaucracy it creates.”
H.R. 3200 rewards middlemen paid to deny medical care recommended by a patient’s physician. These political appointees, charged with “Comparative Effectiveness” determinations, would make treatment recommendations far from the exam room without ever having examined the patient whose treatment is denied…Patient choice is another casualty of H.R. 3200. The effect of the bill’s new bureaucracy, a public (government-controlled) health plan, is described by The Lewin Group. Over 88 million workers would be shifted to the public plan from private coverage. Yearly premiums for individuals with private coverage would increase as the result of cost shifting from the government-sanctioned plan…To the needs of older Americans, the bill mandates an “Advanced Care Planning Consultation” in which senior citizens must meet at least every five years with a doctor or nurse practitioner to discuss “dying with dignity.” (more here)
The confusion of “health care” with medical care is the crucial confusion. Years ago, a study showed that Mormons live a decade longer than other Americans. Are doctors who treat Mormons so much better than the doctors who treat the rest of us? Or do Mormons avoid doing a lot of things that shorten people’s lives?
The point is that health care is largely in your hands. Medical care is in the hands of doctors. Things that depend on what doctors do – cancer survival rates, for example– are already better here than in countries with government-run medical systems…
Imagine finding flyers posted all over a hospital sounding the “alert that a professional union buster was on site”, and that flyer used to identify a nearly 70 year old great grandmother who has to use an electric scooter to get around. What power this person must have to send the California Nurses Association (CNA) in paroxysm’s of fear and panic and to engage in their usually tactics of lies and misinformation. I was met with just such exhibitions fear-mongering and hysteria by CNA recruiters, representatives and supporters when I made a recent visit at the invitation of a fellow nurse from Cy-Fair Hospital in Houston.
Their flyer identified me as a professional union buster, which I guess is a recognition of how much they fear my presence; but truth be told I’m not a professional union buster, and in particular I’m not a nursing union buster. The CNA and many other pro-union people love to use the word union-buster since it tends to invoke images of a Simon LeGreed character replete with requisite black hat and clock and evil laugh.
I have nothing against unions for the blue-collar worker, but I’m far from convinced that professionals such as registered nurses need unions to represent them. So when nurses contact me for my opinion and advise about how to speak for themselves I am always happy to help my fellow RN in advocating for our profession and for themselves. I’m happy to help in the effort of showing nurses they can and do have a strong voice as both an individuals and as a group without paying a nursing union dues of upwards to $80.00 a month for the favor.
I have nothing against unions for the blue-collar worker, but I’m far from convinced that professionals such as registered nurses need unions to represent them. So when nurses contact me for my opinion and advise about how to speak for themselves I am always happy to help my fellow RN in advocating for our profession and for themselves. I’m happy to help in the effort of showing nurses they can and do have a strong voice as both an individuals and as a group without paying a nursing union dues of upwards to $80.00 a month for the favor.
In the case of two recent nursing union attempts, one nursing staffs attempt to stay free from the CNA and one nursing staff attempt to decertify from the CNA. As fate would have it, I was in a position where I could help both in spirit and in person so I did. At the first hospital my fellow nurse and I found CNA representatives playing shenanigans with hospital elevators so that the floor where a “No to the CNA” nurse had been given a meeting room was locked out. This malfunction only affected the one floor that we had to reach on both days, what a coincidence. You may wonder why I think CNA representatives capable of such underhanded techniques. Simple, I still haven’t forgotten a CNA strike in the San Fernando Valley where pro-CNA nurse locked out much need medical equipment, hiding/destroying manuals, etc., so that the relief nurses were hard pressed to provided nursing care to patients many of whom were in intensive care; and the CNA strike was suppose to be all about their concern for patient safety — go figure! And at the second hospital I got treated to the experience of being stalked by not one, not two, but upwards to three CNA representatives at a time. The situation became of such concern that hospital HR and security had to become involved; but I guess I should feel honored that the CNA felt the need to have so many people watching my every move.
Whether or not nurses chose a union to represent them or not should be up to the nurses themselves but this seems to rarely be the case these days. As in the case of the Tenet Healthcare/CNA neutrality agreement Houston nurses that had opposing views to the CNA material, propaganda or message had no one to turn to; at least that’s what the CNA representatives thought, except they overlooked a grassroots network of informed RNs that were available for these nurses to reach out to; which they did and we responded. One would think that the CNA representatives would be excited to learn that nurses were empowering one another, oh that’s right it only counts if the nursing unions are doing the empowering. So sorry, we didn’t get that memo. One would also think that the CNA would invite and encourage an open and lively discussion about the benefits of a nursing union, but they couldn’t be bothered to even accept the invitation extended by one group of nurses to present their viewpoint in an open debate. Instead they skulked about passing out flyers full of misstatements and lies since it so much easier to insult the intelligence of nurses rather than respect them.
In the case of the flyer they suggested that the nurses ask me a set of questions, and I responded with an open letter. One pro-CNA nurse chose to mark up my open letter with graffiti instead of addressing me nurse to nurse. But then again it’s become common practice for pro-nursing union nurses to engage in such childish behavior. It’s a sad day when our honorable profession is marred by such immature behavior. However, I see these as indicators of how much the organizational structure of the CNA fears nurses who chose to take back or carry on with their own voice. In the past several years their membership has been declining (their last official report in 2008 has their membership at just over 72,000 almost a full 8,000 or 13,000 drop depending on which CNA official report you read). I think it’s this drop that has them scrambling for new members in the other 49 states.
But in some parts of our country nurses don’t want anything to do with them, and even when Tenet handed the CNA the proverbial keys to the kingdom providing CNA organizers unfettered and unprecedented access to RNs on the floor, scheduling information and even home addresses and telephone numbers; the CNA has found resistance to their siren song. They couldn’t even gather enough cards at Park Plaza and Northwest Hospitals in Houston to even call an election and they slunk out of Houston so quietly that few even knew they had abandoned their organizational efforts. They accused one, that’s right ONE, nurse of trying to take away the union at Cy-Fair Hospital. What power this one nurse must have, I guess the well over 30% of eligible nurses that signed decertification cards meant nothing, it was all that one nurse’s fault. And this morning we learned that Hahnemann Hospital (another victim of the nefarious Tenet/CNA neutrality agreement) had rejected the union. The CNA had such access to the RNs at Hahnemann that nurses that opposed the CNA had to get the NLRB to intervene just so they could get a meeting room in the bowels of the hospital and finally a table in the cafeteria (shortly before election day) and the union spokespeople whined that this was unfair.
So if our network of nurses, and me, in particular can help our fellow nurses when confronted with such behavior and that makes us professional nursing union busters in the eyes of the union then I guess that’s a cross we’ll just have to bear. I see it as the desperate actions of an organization that knows that people have begun to look behind the curtain that is the California Nurses Association/National Nurses Organizing Committee and they don’t like what they see. The more they howl about RNs empowering each other the more I know that I’m their bête noire and that’s a role I think I shall relish.
Geneviève Clavreul RN Ph.D is President and Founder of the National Nurses Professional Association. She also blogs at The Nurse Unchained.