Wednesday, January 31, 2007

Pfizer's "Astroturf" Movement Against Restricting Medicare Drug Spending

From the Boston Globe comes this story of a drug company's aggressive effort to turn patients into lobbyists.

Ward Wetherell is used to receiving health tips about such topics as 'good' cholesterol from Pfizer Inc. , the world's largest drug company. This month, however, the glossy brochure Pfizer sent to Wetherell's home in Needham tackled a national policy issue days after a crucial House of Representatives vote to lower prescription drug prices.

Congress needs to hear that market forces, not the government, should control prices, said the 'For Living' brochure, which included form letters addressed to Wetherell's representatives in Congress. 'History reminds us that when the government interferes in a free market and controls prices, the results can be dangerous,' it warned.

Industry lobbyists have rallied in speeches, television spots, and full-page print advertising that defends Medicare's year-old prescription drug benefit as a success story that saves seniors $1,200 per year.

But by fostering a so-called 'astroturf' movement -- an artificial grass-roots movement bankrolled by a corporation -- Pfizer's push-back breaks ground, according to a drug industry observer and a former drug industry sales representative.

Jack Cox , a Pfizer spokesman, declined to say how many fliers the company sent, how much the marketing effort cost, or whether it typically drafts form letters for consumers to send to Congress.

The package Pfizer sent to Wetherell included letters addressed to Representative Stephen Lynch and Senator Edward M. Kennedy , who represent the 72-year-old . Unlike the brochure, the letters did not mention Pfizer, but were preprinted with Wetherell's name and address. All he had to do was initial, fold and pop the letters into pre-stamped envelopes. By doing so, Wetherell, a bypass survivor, could instantly become an unpaid Pfizer lobbyist.

The Pfizer letters are beginning to trickle into congressional offices.

One senior who received the pitch decided to criticize Pfizer on its own dime: 'Pfizer asked me to sign and send. I do not agree with their view,' a Milton woman wrote to the Massachusetts Democrat [Representative Stephen Lynch]. 'They spend too much on sales and pushing lunches' for medical residents, she said.

[Senator Ted] Kennedy, chairman of the Health, Education, Labor, and Pensions committee, by Thursday had received fewer than 100 of the Pfizer letters, said a spokeswoman, Melissa Wagoner .

'As with any correspondence from a constituent, even form letters are taken seriously,' Wagoner said.

Because of that, Dr. Jerry Avorn , a Harvard Medical School professor , condemned the covert campaign as 'a distortion of the democratic process.'

Avorn, who tracks drug company marketing, said the industry has already 'succeeded in making patients into sales reps through direct-to-consumer advertising. Now, apparently, the next step is to make patients into lobbyists.'

Gene Carbona , a former Merck & Co. district sales manager, was struck that the letters came from Pfizer, not the Pharmaceutical Research and Manufacturers of America , drug industry lobbyists. 'I've never seen a company make this move on their own, on behalf of themselves,' said Carbona, executive director of the Medical Letter , a subscriber-financed publication that reviews new medicines.

In my view, there is nothing wrong with a pharmaceutical company making its political opinions known. Pharmaceutical companies, like any other organization, have a right to state their opinions and participate openly in the political process.

The problem here is that the company is apparently trying to manipulate patients into making the company's pitch, in a way that disguises the origin of the message. It's akin to stealth marketing, so could it be called stealth lobbying?

It's another example of how the unopposed marketing mentality has taken over the management of pharmaceutical companies. The goal seems to be increase sales and increase company income, no matter who has to be manipulated to do so.

And the pharmaceutical company executives wonder why they inspire so little trust?

FDA Conflicts of Interest Update

Quite a few stories have appeared of late about conflicts of interest affecting the US Food and Drug Administration (FDA). Some are worth updating.

Former FDA Commissioner Crawford to be Sentenced

We posted about the guilty plea provided by former FDA Commissioner Lester Crawford for lying about his family's ownership of stocks in food, beverage, and medical device companies regulated by the FDA. According to the Associated Press (via AZCentral here), Crawford is now about to be sentenced.

Former FDA Commissioner Lester Crawford faces fines that exceed what the veterinarian and food safety expert earned from illegally held stocks he repeatedly lied about owning.

Under a deal worked out between his attorney and federal prosecutors, Crawford agreed to a $50,000 fine and probation.

Crawford pleaded guilty in October to charges of having a conflict of interest and false reporting of information about stocks that he and his wife owned. The stocks were in food, beverage and medical device companies that Crawford regulated while head of the Food and Drug Administration.

Crawford and his wife, Cathy, made roughly $39,000 from exercising options and in dividends from the stocks they held in the FDA-regulated companies.

In court, Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the FDA, which is illegal. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the misdemeanor charges.
Congress to Investigate Possible Conflicts Involving FDA Information Technology

We also posted about how the FDA awarded a big internal information technology contract to a company called Platinum Solutions, one of whose executives was married to the FDA official who was initially in charge of the data systems branch of the FDA under which the contract was let.

Last week the Los Angeles Times reported that the leaders from both parties of the US House Energy and Commerce Committee have opened an enquiry of the contract given to Platinum Solutions, and the FDA internal investigation of the contract that apparently found no fault with the process.

Coupled with recent stories about conflicts of interest affecting FDA expert panels (e.g., see this post), these exemplify how the web of conflicts of interest have affected the leadership of every kind of health care organization. Keep in mind that although the two cases above may involve negative incentives for those involved, such conflicts are not illegal, and may often proceed unimpeded in US for-profit and not-for-profit health care organizations.

If we want health care organizations to put health care first, ahead of the personal financial interests of their leaders, we will have to develop stronger negative incentives for this kind of behavior, inside or out of government.

Monday, January 29, 2007

"Not Something We Want to Publicise" - Spin Doctoring Drug Promotion

The British Broadcasting Corporation (BBC) television program Panorama just did an expose that charged that GlaxoSmithKline "distorted trial results of an anti-depressant, [Seroxat in the UK, Paxil in the US, chemical name paroxetine] covering up a link with suicidal teenagers." To quote the BBC's web-page, with some editing:
Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced 'independent' academics.

GSK told Panorama: 'GSK utterly rejects any suggestion that it has improperly withheld drug trial information.'

GSK's biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

Emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond....

An email from a public relations executive working for GSK ... said: 'Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.'

The BBC also published a commentary by Fiona Godlee, Editor of the British Medical Journal.

What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.

Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.

So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure.

We shouldn't have to rely on investigative journalists to ask the difficult questions.
So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest?

And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking.

I have little to add , except repeating what I have said before. Patients and physicians require the best possible information about benefits and harms of treatments to make the best decisions about such treatments. When those with vested interests in supporting a particular treatment distort the information available to make such decisions, they risk harming patients. Executives of pharmaceutical (and biotechnology and device) companies who wonder why the public and many physicians distrust their companies should look no farther than stories like this. Physicians have an obligation to get the best possible evidence prior to making decisions for patients, and should, as Fiona Godlee pointed out, expose any efforts by those with vested interests to distort or manipulate such evidence.

ADDENDUM (30 January, 2007) See the analysis of this case, as reported in much more detail in the actual BBC telecast, in the Clinical Psychology and Psychiatry blog, focusing on the involvement of Dr Martin Keller, Chair of Psychiatry at Brown University. [Full disclosure: I am on the voluntary faculty at Brown.]

ADDENDUM (1 February, 2007) See additional posts on the Clinical Psychology and Psychiatry blog here, here, and here.

Friday, January 26, 2007

HRDI Settlement Disbands "Anticompetitive, Secret Society"

Last summer we posted about the Healthcare Research and Development Institute (HRDI). HRDI is a for-profit owned by a number of the top executives of some of the US best known hospital systems and academic medical centers. According to an article in the NY Times, HRDI gives a limited number of drug, device, and biotechnology companies access to these executives, for a stiff fee.

According to yesterday's NY Times, the Connecticut Attorney General, Richard Blumenthal, just obtained a settlement from HRDI that calls for the company to pay a $150,000 fine, and disband as a for-profit company. A digest of the story, edited and re-ordered, is below:

Under pressure from the Connecticut attorney general, a consulting group owned by some of the country’s most influential hospital executives agreed yesterday to stop selling marketing advice to vendors who do millions of dollars in business with nonprofit hospitals across the nation, including their own.

Known as H.R.D.I., the group is owned by about three dozen hospital executives, but it is underwritten by 40 or so of its handpicked corporate members who sell drugs, medical devices and financial services to hospitals.

H.R.D.I.’s owners are among the most influential members of the hospital industry. They have included executives of group purchasing organizations, which negotiate millions of dollars in supply contracts on behalf of nonprofit hospitals across the country.

Despite its elite membership, H.R.D.I. has maintained a low public profile. Its meetings were not open to the public or to vendors who were not members. According to H.R.D.I. rules, only two vendors in any product line could belong to the group.

Last summer, The New York Times reported on an H.R.D.I. meeting in May at the Broadmoor, a Colorado Springs resort, where 40 health care companies sought advice from hospital executives. Market leaders like Eli Lilly, Johnson & Johnson, Morgan Stanley and Citigroup attended, along with many smaller companies.

The companies paid the travel expenses for hospital officials and their spouses and sponsored golf and tennis outings, among other events.

H.R.D.I.’s rules prohibited vendors from using its meetings to sell products. In one instance, the group expelled a company for violating that rule. But over all, state investigators said, the rules were either ineffective or not enforced.

Suppliers, for example, lobbied H.R.D.I. employees for consultations with executives at hospitals where they wanted to make sales, Connecticut officials said. One vendor, after consulting with an H.R.D.I. hospital executive, went from zero sales at the executive’s hospital to $3.6 million in annual sales, investigators said.

'Various vendors identified membership in H.R.D.I. as an important, if not their most important, ‘relationship builder’ in the health care industry,' the agreement states.

According to a settlement agreement signed by H.R.D.I. and the state attorneys general in Connecticut and Florida, hospital members may no longer accept consulting fees and free trips to resorts from hospital suppliers. The agreement did not include any admission of wrongdoing by H.R.D.I. or its owners.

H.R.D.I., which was founded five decades ago as an educational group, will change from a profit-making company into a nonprofit group financed only by hospitals or their executives. Supply companies may not initially join the new group, called the Health Education Network, nor will they be permitted to have any financial links to it.

Based in Pensacola, Fla., H.RD.I. has long maintained that its sole purpose was to improve products and services in health care.

'H.R.D.I. never has and does not now buy, sell or encourage the purchase or sale of products or services,' said Diane Appleyard, the group’s president and chief executive. 'After more than 23 months of investigation, no wrongdoing was found and no charges were filed.'

As reported by the Times, and in two Connecticut newspapers, the Hartford Courant and the New Haven Register, Blumenthal had some choice words to describe HRDI and his settlement with it.

[The agreement] shatters an anticompetitive, secret society, an elite and exclusive club of premier hospital executives and select hospital supply businesses that restrained competition to the detriment of patients and providers. [Times]

These practices threatened to inflate health care costs to patients and taxpayers - stifling competition in almost every health care supply and services market. [Courant]

[HRDI was an] exclusive club, [better named] Healthcare Titans of America — an organization where the most powerful vendors and hospital CEOs enjoyed lucrative marketing opportunities, and lavish accommodations. [Register]

HRDI claimed to offer health care consulting services to industry players. In reality, it was an exclusive network that shut out potential competitors in various health care markets — everything from pharmaceuticals, syringes, medical devices and financial and consulting services. [Register]

Given Blumenthal's scathing words, it is reasonable to ask just who are the members of HRDI's "exclusive club?" The list is on the HRDI web-site:

It will be interesting, if that's the word, to see if there will be any discussion about and any repercussions for the participation of the leaders of these distinguished organizations in what one well-known state Attorney General called "an anticompetitive, secret society, an elite and exclusive club." Unfortunately, our previous observations of the anechoic effect suggest that there will be little response and no repercussions. In healthcare, leaders of revered organizations often seem to be able to hide under the cloak of their organizations' reputations, even if they have conducted themselves in ways that contradict their organizations' missions.

But this is one striking and broad demonstration about how the leadership of large health care organizations' threatens physicians' and other health care professionals' core values. This case, along with many others that have appeared on Health Care Renewal, suggest we need a major overhaul of the governance of US (and other countries') health care organizations if we really want to improve access, costs, and quality.

WHAT CAN BE DONE? - If you live in a community served by one of the health care systems above, or if you have any relationship with one of the systems, push to make the story of HRDI public, and then push for more transparent, accountable, and ethical governance of that health care system.

Tuesday, January 23, 2007

More About the Zyprexa Marketing Memos

We previously posted (here, here, here, and here) about allegations in a New York Times series that Eli Lilly and Company had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

More keeps coming out about this topic. The Times (UK) added some information about the internal memos.

Eli Lilly, the American pharmaceutical giant that has consistently denied any link between Zyprexa, its antipsychotic drug, and diabetes, was concerned about the side-effects of the drug as early as 1998, according to documents seen by The Times.

A series of leaked court documents seen by The Times suggested that the company was aware of the risks of weight gain, hyperglycemia (high blood sugar) and diabetes associated with the drug but presented them as common problems across the whole class of schizophrenia drugs and not restricted to Zyprexa.

In one document dated October 9, 2000, Robert Baker, a senior Lilly clinical research physician, e-mailed colleagues about a meeting of an academic advisory board he had attended in Atlanta. It had 'reinforced my impression that hyperglycemia remains quite a threat for olanzapine and may merit increasing even further medical attention and marketing focus on this topic'. Dr Baker added: '[The board was] quite impressed by the magnitude of weight gain on olanzapine and implications for glucose.'

Another internal document dated October 14-15, 1998, described the risk of weight gain as a 'top threat' to Zyprexa.

A statement from Lilly said that the documents represented 'a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly’s conduct nor represent an accurate view of Lilly company strategy or activities.'

It added that the documents were 'selectively and illegally leaked'.

Meanwhile, the New York Times reported on the growing number of investigations of how Eli Lilly marketed Zyprexa.

On Thursday, lawyers from the consumer protection division of the Illinois attorney general’s office demanded that Lilly hand over marketing materials, e-mail messages, and other documents with information about promotion of Zyprexa. Vermont investigators issued a similar order yesterday morning.

The orders are the civil equivalents of criminal subpoenas, according to Deborah Hagan, the chief of the Illinois consumer protection division.

Illinois and Vermont are now part of a coordinated five-state civil investigation into the way Lilly promoted Zyprexa, a treatment for schizophrenia and bipolar disorder. The states are investigating whether Lilly tried to hide Zyprexa’s risk of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder.

The orders on Thursday and yesterday are the first formal demands for Lilly documents from state attorneys and they indicate an escalation of the investigation, according to Ms. Hagan and Julie Brill, who is an assistant attorney general in Vermont.

In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. 'We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,' the company said. We cannot comment further about this or other ongoing investigations.'

While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Medicaid represents a sizable percentage of the drug’s overall sales because many people who take the medicine are disabled and do not work.

Sounding like a broken record (if anyone remembers what that means), patients and physicians need the best possible evidence about benefits and harms to decide on treatments. Any attempts to hide such evidence in support of vested financial interests may hurt patients. A pharmaceutical (or biotechnology or device) company that seeks to quiet the discussion of the benefits and harms of their products should not inspire trust.

See also related comments here on the Clinical Psychology and Psychiatry blog and here and here on the PharmaGossip blog.

Monday, January 22, 2007

Top Pharmacy Chain Executives Indicted for Conspiracy, Fraud and Bribery

Late last week, the Providence Journal reported the indictment of two top executives of CVS, one of the largest US pharmacy chains:

[Carlos] Ortiz and another prominent CVS executive, John R. 'Jack' Kramer, were accused in a 23-count indictment of conspiracy, fraud and bribery for allegedly hiring [former Rhode Island State Senator John] Celona as a $1,000-a-month consultant from early 2000 to the fall of 2003, paying him a total of about $45,000 and also lavishing him with golf outings, trips to Florida and California and tickets to professional sporting events.

Although Celona was ostensibly paid to improve CVS’ image among consumers, U.S. Attorney Robert Clark Corrente charged that Kramer and Ortiz put Celona on the payroll 'to advance the company’s legislative agenda…through illicit payments to Senator Celona.'

In return, the indictment said, Celona used his political clout to kill controversial 'pharmacy choice' legislation that would have expanded the Rhode Island network of pharmacies that accepted Blue Cross reimbursements. CVS, which dominated the restricted network, opposed the bill so strongly that the company tied Kramer’s and Ortiz’s performance reviews to defeating the legislation.

Killing the legislation, Ortiz wrote in one review, had 'helped to protect millions of dollars of sales.'

The indictment says that Celona also opposed the licensing of Canadian pharmacies in Rhode Island, pushed legislation to allow the electronic filing of prescriptions and promoted the creation of a state-backed loan program for pharmacy students.

Celona pleaded guilty in 2005 to selling his office to CVS, Blue Cross & Blue Shield of Rhode Island and Roger Williams Medical Center, and is due to be sentenced Jan. 31. He testified last fall in the corruption trial leading to the conviction of former Roger Williams executives Robert Urciuoli and Frances Driscoll.

Yesterday’s indictment left one major question unanswered: Will the investigation reach Tom Ryan, the chief executive of the nation’s largest drugstore chain...?

The indictment refers cryptically to a 1999 memo that Ortiz sent to a number of CVS officials, including 'Executive #1,' in which he discussed pharmacy choice and wrote, that he was 'hopeful that we will be able to kill it in the Senate Corporations Committee.' However, the indictment also charges that Kramer and Ortiz failed to have Celona’s consulting agreement reviewed and approved by CVS’ chief financial officer; and others, as required under company policy governing consultants.

Ryan has declined to comment on whether he knew of the arrangement. The indictment mentions Celona’s attendance at a social function at the home of 'CVS Executive #1,' but doesn’t elaborate on that person’s possible knowledge of the relationship.

'No charges were filed against the company, which has fully cooperated with the government in connection with its investigation of this matter since its inception,' CVS said in a statement yesterday.

Of course, an indictment does not prove guilt. But this is just the latest example of allegations of criminal behavior made against the leadership of health care organizations of every type.

It seems that for far too many executives and managers of US health care organizations, conspiracy, fraud, and bribery are just part of another day at the office. It is likely that such criminal conduct, plus the probably much more common conflicts of interest, and just plain mismanagement that seem everywhere in the leadership of US (and global) health care are important, maybe the most important explanations of why we seem unable to address rising costs, declining access, stagnant quality, and demoralization of health care professionals.

Deja vu all over again: "pertussis" in NH

Today's (22 January 2007) NY Times includes an intriguing piece on the pertussis "epidemic that wasn't" at Dartmouth Hitchcock Medical Center.

Another case of the "allure of the new." So many of the DHMC healthcare workers were coughing. And there've been all these recent articles on the prevalence of whooping cough (pertussis) among persons who've coughed for protracted periods. So the folks at Dartmouth used PCR to test for this fastidious bug. Result: over 1000 workers furloughed for some period of time.

It reminds one of the advent of bacteriology, in the late 19th and early 20th century. Back in the day--back in that day--there was such allure-of-the-new that diseases like beri-beri, pellagra, and even psychiatric illness were ascribed to causative bacterial organisms.

Which were present, no doubt, in some of those non-infectious cases.

But it was--and is--the age old problem of the false positive. None of this indicts the good folks at DHMC, one of the best in the nation. But this episode illustrates beautifully the need for continued emphasis on EBM in our curricula and our thought processes. And real skepticism about the allure of the latest and greatest in high technology methods, until we have adequately "tested the test."

Friday, January 19, 2007

NIH Cancels Guideline Development Meeting After Conflicts of Interest Revealed

The Wall Street Journal just reported that the NIH cancelled a planned meeting for drafting guidelines about neonatal herpes after receiving a letter written by a group of individuals and organizations, lead by the Center for Science in the Public Interest, that raised concerns about conflicts of interest affecting many of the meeting participants. (Full disclosure: I was one of the individuals who signed the letter.)

The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.

The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.

The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.

The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.

The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.

The group wrote that the NIH agency 'must be an honest broker in the development of medical evidence that will inform clinical practice' and that the NIH must ensure that all members of guideline-writing committees are 'free from conflicts of interest.'

The letter writers said the scheduled meeting on herpes added to a 'sad record' at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.

According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo[SmithKline] on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk.

The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.

Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.

The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.

See also CSPI's press release here.

Note that we recently posted how GlaxoSmithKline funds speakers who seem to favor clinical policies that just might end up increasing the use of the GSK drug valacyclovir (Valtrex) for genital herpes infections. We also recently posted about how Amgen Inc. supported development of guidelines that might lead to aggressive use of epoetin (Epogen), which it manufactures, for anemia in patients with chronic kidney failure.

As we have said before, this is a reminder that just because a set of recommendations is called a guideline, or is written under the auspices of some august academic or scientific organization does not guarantee that its recommendations are based on the best evidence, or are not influenced by vested interests. And yet guidelines remain a buzz word for those who say they want to control health care costs, and improve quality and access. And giving guidelines teeth, otherwise known as "pay for performance," (P4P) is now the most fashionable solution to the cost, quality, and access problems. (See post here.)

At least, in the current instance, quick action, lead by the Center for Science in the Public Interest, may have stalled the development of yet another guideline that could have been unduly influenced by those wishing to promote vested interests. I am proud to have had a very minor role in this action.

Thursday, January 18, 2007

University Medical Center of Southern Nevada's CEO Fired After Undisclosed Financial Losses Discovered, Criminal Allegations Made

Amidst all the stories about pharmaceutical, biotechnology, and device companies, do not forget that management problems also afflict hospitals and health care systems. Proving that stories do not always stay in Vegas, the Las Vegas Review-Journal reported the firing of the CEO of University Medical Center of Southern Nevada, a major teaching hospital of the University of Nevada School of Medicine, and home of the state's only level 1 trauma center, amidst allegations of no-bid, no-work contracts given to his friends and associates.

University Medical Center CEO Lacy Thomas was fired Tuesday shortly after police revealed he is under criminal investigation and outside auditors reported that the public hospital lost $34.3 million last year, nearly twice the figure he'd given Clark County commissioners in November.

County Manager Virginia Valentine said that even though the theft, fraud and criminal misconduct allegations against Thomas are still under investigation, she decided to terminate his tenure heading UMC because he repeatedly misled county officials about the fiscal health of the hospital, which has hemorrhaged some $50 million during the past two years.

'I had concerns about his lack of transparency regarding the hospital's financial situation,' Valentine said moments after presenting the hospital's CEO with notice of his firing.

One of the people whose firm is under investigation for its dealings with the medical center played the race card.

But Thomas' friend Bill Taylor, owner of one of the Chicago companies whose contracts with UMC police are investigating, opined that Thomas is the victim of a racial vendetta.

'If this man was white, this wouldn't be happening,' Taylor said. 'He's an African-American in a redneck state. They hated his guts the day he walked in there. ... There's a lot of racist folks that don't want him there, and they'll do anything to get him out of there, including lying.'

The story has elements that will be familiar to readers of Health Care Renewal. The allegations about the former CEO were extensive, and also involved two other "C level" hospital executives. Hospital managers who made the allegations had been fired by hospital leadership.

Thomas, 50, joined UMC three years ago after leaving his job as director of John H. Stroger Jr. Hospital of Cook County, formerly Cook County Hospital, in Chicago.

Authorities are investigating Thomas' ties to several other Chicagoans, according to the affidavit detectives filed seeking permission to search UMC on Tuesday.

Besides Thomas' office, police searched the offices of Chief Financial Officer Richard Powell and Marlo Hodges, the hospital's chief operations officer.

The affidavit states that police suspect that Powell and Hodges, both former employees of Thomas from Chicago's public hospital, had knowledge of suspected fraudulent contracts Thomas arranged for friends 'and even assisted in the crimes.'

Before Tuesday's search of UMC, police had gathered much of their information from two former UMC executives ousted by Thomas.

Former COO Blaine Claypool and former CFO Mike Walsh told police that Thomas bypassed them and awarded hospital contracts 'to businesses of his friends from the Chicago area.' The contracts were all 'professional services' contracts not subject to a competitive process in which public agencies must publicize a job offer and accept the lowest bid for the work.

Several of the companies did not have business licenses in Nevada or Illinois, the affidavit states.

Claypool, Walsh and other UMC officials told police no work product ever resulted from the contracts, but five of the Chicago-based vendors received anywhere from $22,575 to $673,268 for services rendered.

Claypool told police that Thomas was a close friend of ACS Senior Vice President Bob Mills and was flown to the Virgin Islands to observe consulting work the company was performing at a hospital on St. Thomas.

Upon Thomas' return, he drafted a contract with ACS to take over collecting bills, handling patient admitting and record-keeping at UMC.

'Claypool indicated that he and Walsh told Thomas numerous times that the contract was not in the best interests of UMC and that due to the wording in the contract, (ACS) would receive money for basically doing nothing,' the affidavit states. 'Thomas ignored his objections.'

County Auditor Jeremiah Carroll found the contract Thomas recommended with ACS Consulting -- designed to bolster the hospital's bottom line -- actually led to a $6 million fall in revenue during its first year in place.

Carroll's staff also found flaws in the ACS agreement that allowed the company to collect more than $1 million in fees even though the firm was supposedly working on a pay-for-performance basis. ACS also received a lucrative commission by arranging the sale of UMC's bad debt for a fraction of its worth, a bungled transaction criticized in the audit.

Claypool and Walsh also told police Thomas was friends with owners or key employees of other Chicago businesses with whom he arranged contracts.

For instance, Claypool told police that Thomas was a former fraternity brother of the president of Frasier Systems Group, Gregory Boone. The company was awarded a contract to evaluate how to speed up UMC's business office.

Boone briefly visited UMC, but Claypool never saw a completed work product from the company, the affidavit said. A source inside UMC told police detectives the company has been paid $673,268 from UMC coffers.

Whether the allegations of criminal conduct are true, the former CEO was apparently presiding over mounting losses which he did not clearly explain to those to whom he was accountable.

County officials stressed that having a much bigger loss than the $18.8 million deficit Thomas reported to them in November would not affect patient care or the hospital's abilities to meet its payroll obligations.

However, they acknowledged for the first time Tuesday that taxpayers will be on the hook for a subsidy to reduce the red ink spilling from UMC.

'There will be a bailout,' said George Stevens, the county's chief financial officer. 'The reality is the hospital has lost $50 million in two years.'

Meanwhile, Tuesday saw the culmination of concerns that commissioners, who serve as UMC's board of trustees, began raising in November about the lack of information they were receiving on the hospital's finances.

While Thomas, a certified public accountant, gave them private assurances everything was OK, he stopped delivering mandated monthly reports on the hospital's balance sheet in May.

Asked for a public report, Thomas told commissioners two months ago that the hospital had lost an estimated $18.8 million in the fiscal year that ended June 30, and assured them that the hospital was in good shape.

The hospital had been budgeted to lose $12 million.

But the hospital's outside auditors disagreed with his figures in a preliminary annual audit presented to commissioners Tuesday.

How this will affect the medical school and local medical education and research is unclear.

Dr. James Lenhart, vice dean of the School of Medicine which has 110 physicians under contract to provide medical services at UMC, said he was concerned by Tuesday's firing of Thomas and the criminal probe.

He said the School of Medicine will want to know about the hospital's new leadership and whether the county can find a quality replacement for Thomas given the recent problems.

Said Lenhart: 'It would appear, with everything that has transpired, we may have hired the wrong person.'

Of course, the University Medical Center of Southern Nevada has plenty of company there. Health Care Renewal has now aggregated quite a few stories of health care organizations, including other academic medical centers like Fletcher-Allen Health Care in Vermont (see post here), Roger Williams Medical Center here in Rhode Island (see most recent post here), and the University of Medicine and Dentistry of New Jersey (see most recent post here), which, to put it charitably, hired the wrong people. And we have aggregated many other stories involving the leadership of government agencies, managed care organizations, and pharmaceutical, biotechnology, and device manufacturers.

There clearly is a systemic problem with mismanagement by, conflicts of interest affecting, and outright crime and corruption committed by the leadership of too many health care organizations.

These big elephants in health care's living room are undoubtably partially responsible for rising costs, declining access, poor quality, and demoralized health care professionals. Yet the ongoing "anechoic effect" seems to prevent most people in health care from even talking about these systemic problems.

We will continue to talk about them on Health Care Renewal.

Wednesday, January 17, 2007

Medtronic Marketers Try to Sell Implantable Cardiac Defibrillators Direct to Patients

The latest subject of direct to consumer (DTC) advertising is medical devices. The Minneapolis Star-Tribune reports,

Medical technology giant Medtronic Inc. will launch a $100 million marketing campaign today to raise awareness about the dangers of sudden cardiac arrest -- and the role of heart defibrillators in saving lives.

Fridley-based Medtronic said the 'What's Inside' sudden cardiac arrest ad campaign is part of a bigger awareness push that is the largest in size and scope in company history.

'This is about saving lives,' said Dr. David Steinhaus, vice president and medical director of Medtronic's Cardiac Rhythm Disease Management division. 'Sudden cardiac arrest kills more people than breast cancer, lung cancer and HIV/AIDS combined.'

Sudden cardiac arrest can be prevented with a device called an implantable cardioverter defibrillator (ICD) -- a stopwatch-sized device implanted in the chest that shocks an errantly beating heart back into rhythm. But a series of safety recalls by manufacturers in 2005 -- including market leader Medtronic -- dampened demand for the device in the past year

Part of the problem is that patients who need the devices aren't necessarily getting them -- Medtronic estimates roughly 850,000 Americans are in this category.
Sometimes prospective patients don't have symptoms, which can make it difficult for doctors to persuade them to undergo an ICD implant procedure, Medtronic's Steinhaus said.

In addition, sometimes patients are not referred to the appropriate specialists (called electrophysiologists) who implant the devices -- which is why Medtronic is also targeting the general cardiology community with physician education programs, he said.

Sorry, but to me, this one smells bad from the get go.

The kicker here is the populations of patients for whom ICDs might be indicated. The notion that there are patients who ought to have ICDs implanted, but are walking around, without any symptoms, in blissful ignorance of this fact does not make a lot of sense to me.

Right now, there are two groups of patients for whom ICDs might have benefits that outweigh their harms. The first are patients who have already had a "near sudden death" experience, i.e., patients who have dropped their blood pressure, or fainted (had syncope) due to a particularly dangerous kind of rapid heart beat (ventricular tachycardia). To have had such diagnoses, such patients, have had to already come to medical attention. They do not need advertising campaigns to tell them they ought to have an ICD. [For a discussion of this group, see Josephson ME et al. The role of the implantable cardioverter-defibrillator for prevention of sudden cardiac death. Ann Intern Med 2000; 133: 901-910.]

The second group are patients at very high risk of such deranged heart rhythms. The MADIT II Trial suggested that patients who have had a heart attack (myocardial infarction) and have poor heart function (left ventricular ejection fraction less than 30%) have increased survival after placement of an ICD. [Moss AJ et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-883.] The SCD-HeFT trial suggested that patients with congestive heart failure who are moderately symptomatic (New York Heart Association classes II and III) and have a ventricular ejection fraction of less than 35% may also so benefit. [Gardy GH et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-237.] Again, most people who have had myocardial infarction resulting in poor heart function are not walking around blissfully unaware of these major problems, nor are people with at least moderately symptomatic heart failure.

Furthermore, there are many legitimate reasons that people who fit into the categories listed above should not have ICDs. In particular, many people with such serious heart disease also have other severe medical problems. The benefits versus harms of ICDs is unknown in such patients, who would have been excluded from the trials above. (For example, MADIT II excluded anyone with another severe disease that increased the risk of death during the trial time-frame.) Patients with other severe medical problems could die or become seriously ill from these other problems before having any opportunity for an ICD to prevent a dangerous rhythm disturbance.

So I question the whole notion that the DTC advertising would flush out tens of thousands of patients who were totally unaware that they could benefit from ICD placement.

So why do this advertising campaign? Is it just a result of how marketers have come to dominate nearly every health care organization, including device manufacturers? Many of those of the marketing persuasion seem to be totally focused on selling more product. That may be good for the marketers' careers, but it may not be good for those having these particular products implanted in their chests.

In health care, our goal should be first only to do things to patients whose benefits are likely to outweigh their harms, not just to move expensive products off the shelves.

Hat tips to the Over My Med Body blog and the Schwitzer Health News Blog.

Please also see the comments on SurgeonsBlog, on having one's mind blown by one of the print advertisements from this campaign in the New York Times.

Monday, January 15, 2007

Unringing the Zyprexa Memos Bell

We previously posted (here, here and here) about allegations in a New York Times series that Eli Lilly and Company had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

The New York Times has continued its reporting on the subject,

It all began with Dr. David Egilman of Massachusetts, who was a consulting witness in ongoing litigation against Lilly. Dr. Egilman had in his possession a trove of internal Lilly documents — not all of them flattering to the company — sealed by the court as part of that litigation.

Comes James B. Gottstein, a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state. He somehow got wind (and precisely how is the subject of separate legal jujitsu) that Dr. Egilman had some interesting documents.

Mr. Gottstein sends Dr. Egilman a subpoena for copies. Hell begins breaking loose.

In a letter dated Dec. 6, Dr. Egilman informed Lilly’s lawyers, as was required by the order sealing the documents, that he had been subpoenaed. Lilly’s lawyers expressed their deep displeasure in a Dec. 14 letter to Mr. Gottstein, and politely told him to back off. In a response a day later, Mr. Gottstein informed them, among other things, that it was too late, and that some of the material had already been produced.

It seems Mr. Gottstein was also apparently in a sharing mood, which is how hundreds of pages ended up with a Times reporter, Alex Berenson — and about a dozen or so other individuals and organizations.

United States District Judge Jack B. Weinstein ordered Mr. Gottstein to provide a list of recipients to whom he had distributed the contraband pages, and to collect each copy back.

The Times, which politely declined to oblige, has since been left out of the legal wrangling, but on Dec. 29, the court temporarily enjoined an expansive list — 14 named individuals, two health advocacy groups (MindFreedom International and the Alliance for Human Research Protection), their Web sites, and a site devoted to the Zyprexa issue — not just from 'further disseminating these documents.' They were specifically ordered to communicate the injunction to anyone else who had copies, and enjoined from 'posting information to Web sites to facilitate dissemination of these documents.'

That’s right — it appeared that even writing on their Web sites something like, 'Hey, there’s a site in Brazil where you can get those Zyprexa documents,' would run afoul of the injunction.

The order was extended by Judge Weinstein on Jan. 4, and tomorrow the court will revisit the issue at length.

So now there are serious free speech issues (involving the First Amendment to the US Constitution) involved.

While surely painful for Lilly, the online proliferation began flirting with some bedrock principles of free speech and press, as well as some practical realities that looked a fair bit like toothpaste out of its tube.

As Mr. von Lohmann and the Electronic Frontier Foundation see it, the injunction is simply untenable. Whatever the legal merits of Lilly’s claims against Mr. Gottstein and Dr. Egilman for violating the seal, the court’s power to stifle the ever-growing chain of unrelated individuals and Web sites who, after one or two degrees of remove, had nothing to do with the Lilly litigation, cannot extend to infinity. Very quickly, Mr. von Lohmann argues, you are dealing with ordinary citizens who are merely trading in and discussing documents of interest to public health.

There is also a traditionally high bar set for placing prior restraint on the press — which, whether Judge Weinstein recognizes it or not, very much includes a colony of citizen journalists feeding a wiki.

For now, copies of the Lilly documents sit defiantly on servers in Sweden, and under a domain registered at Christmas Island, the Australian dot in the ocean 224 miles off the coast of Java. 'Proudly served from outside the United States,' the site declares. There are surely others.

On his TortsProf blog, William G. Childs, an assistant professor at Western New England School of Law in Springfield, Mass., put it this way in a headline: 'Judge Tries to Unring Bell Hanging Around Neck of Horse Already Out of Barn Being Carried on Ship That Has Sailed.'

I cannot comment on the legal merits of the argument that the Eli Lilly memos about Zyprexa should not have been published.

It does seem to me that any effort to restrict discussion of the case by parties not involved in the case would be a serious general affront to free speech.

Furthermore, to make the best possible medical decisions for individual patients, the patients and their health care professionals need the best possible evidence about the benefits and harms of therapy. Thus, patients, health care professionals, and ultimately the public have a need to know about the benefits and harms of medications like Zyprexa, and about any attempts to suppress or manipulate such evidence by interested parties, particularly the medications' manufacturers.

Although I can appreciate Eli Lilly's interest in having a fair day in court, the company's attempts to corral documents that put its managers in an unflattering light do not enhance trust in how the company is run.

Hat tip (see this post) in the Clinical Psychology and Psychiatry blog.

Consent Decree Stops Shipping Some "Transformational Medical Technologies"

From the Deseret News, a report that the US Food and Drug Administration (FDA) has obtained a consent decree to force GE OEC Medical Systems, a subsidary of GE Healthcare, which is in turn a subsidiary of General Electric, to stop shipping fluoroscopic X-ray and navigation systems used in orthopedic, cardiac, vascular and urologic surgical procedures. GE Healthcare boasts of providing "transformational medical technologies and services that are shaping a new age of patient care."

Here's the story, edited and re-sequenced a bit,

General Electric bought OEC Medical Systems in 1999. It is part of the $15 billion GE Healthcare division with some 70 facilities worldwide. Since that time, OEC revenue more than doubled to some $500 million annually. Profit margins have soared to 50 percent, meaning the company clears about $250 million a year. The company has a dominant 70 percent market share.

The FDA issued GE OEC Medical Systems, 384 Wright Brothers Drive, a warning letter in March 2005 after an audit revealed serious quality control lapses in manufacturing, packing, storage and installation of its equipment.

For example, the inspection showed that test technicians for more than a year photocopied results from one device to another rather than create new documents for each device. It also revealed failure to timely report equipment malfunctions 'likely to cause or contribute to a death or injury if the malfunction were to recur.'

A follow-up audit last August showed the company still wasn't in compliance with FDA quality-assurance requirements.

Upper management had ignored internal pleas for money and personnel to correct the deficiencies identified in the FDA audits, sources told the Deseret Morning News.
GE OEC Medical Systems ceased shipping its fluoroscopic X-ray and navigation systems last September after audits revealed numerous violations of federal quality assurance regulations. About 30 employees went on furlough.

On Friday, the FDA announced a consent decree with the company, a subsidiary of global giant General Electric, prohibiting it from making and distributing the equipment until it complies with federal law. GE OEC Medical Systems is part of the GE Healthcare division. The decree, which serves as a permanent injunction, was filed in U.S. District Court for Utah.

In a statement, Pete McCabe, president and CEO, Surgery, GE OEC Medical Systems, said the company is committed to making safe products and following FDA rules.

'Patient safety and quality continue to be our top priorities,' he said in a company statement.
This story reminds us of some important points. The profit margins for the manufacture of medical devices are huge. Large corporations not usually identified as health care corporations, like General Electric, play important roles in the huge and complex health care system, such as manufacturing medical devices. Such corporations are not immune to the problems that now plague "pure" health care organizations. In the current case, there were allegations of mis-handled safety inspections, and "upper management's" unwillingness to deal with safety problems in one of the company's new "transformational technologies." Finally, although patient safety problems are most often attributed to errors by health care professionals, they can also result from mismanagement within health care organizations.

Marketing Not Fit for a Dog

Maybe it's because my family has adopted two "shelter dogs" that I noticed this story reported here and here by the Cleveland Plain Dealer.

To summarize, a neuro-surgeon at the Cleveland Clinic "caused an aneurysm in the brain of a large, mixed-breed dog" to demonstrate the use of a medical device made by Micrus Endovascular Corp, "staged for the manufacturer's salespeople." So, "about two-dozen salespeople watched the demonstration Wednesday at at least some participated in a hands, on exercise.... The dog was anesthetized during the procedure and afterward was killed." Although the surgeon had submitted "an application to the hospital's Institutional Animal Control and Use Committee.... The doctor had not heard back from the committee before the demonstration and wrongly assumed it was OK.... But the [Cleveland Clinic] spokeswomen said the committe would have rejected the request because it does ot allow doctors to use animals for the sole purpose of sales training."

An accompanying editorial, entitled "Death of a Salesdog," in the Plain Dealer noted, "it's one thing to sacrifice animals in the name of legitimate medical research. It's another to do so to promote sales of a product. The clinic neurologist [sic] apparently missed that crucial distinction."

It's just one incident, involving one dog, but it graphically illustrates that when it comes to marketing pricy health care products, common sense and notions of morality seem to go out the window. Have they no shame?

I should also add that although the neurosurgeon's unfeeling actions surely deserve censure, so too do the participation by the Micrus Endovascular Corp. salespeople, and the presumed endorsement of this activity by the company marketers. We should certainly hold physicians and surgeons to high ethical standards, but there also ought to be some ethical standards for the manufacture and marketing of health care devices that are meant to be used in humans (or dogs).

Friday, January 12, 2007

Eli Lilly Threatens Zyprexa Whistle-Blowers with "Very Severe" Sanctions

We previously posted (here and here) about allegations in a New York Times series that Eli Lilly had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported.

The latest issue of the British Medical Journal featured a news article by Jeanne Lenzer about how Lilly has tried to suppress publication of the internal memos on which the Times based its series. [Lenzer J. Drug company tries to suppress internal memos. Brit Med J 2007; 334: 59. ]Lenzer wrote,

The drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet.

The documents created a furore after they were leaked to the New York Times, which reported that they showed that Eli Lilly "engaged in a decade-long effort to play down the health risks of Zyprexa" (

Eli Lilly disclosed the internal documents to the attorneys for the plaintiffs in a pending class action suit in the US District Court for the Eastern District of New York, but they remained confidential. However, Jim Gottstein, a lawyer representing a client in a separate court case in Alaska complaining about the coercive use of antipsychotic drugs, subpoenaed the documents from David Egilman, a prominent occupational health expert and an expert witness in the New York class action suit.

Alex Reinert, attorney for Dr Egilman, said that his client did not violate the law in releasing the documents under subpoena to Mr Gottstein. Mr Gottstein, who acknowledges giving the documents to the New York Times, said that he didn't violate the law as he was not a party to the confidentiality agreement issued in the New York class action suit.

After the injunction was granted to Eli Lilly the documents rapidly disappeared from the internet. The company was given access to Dr Egilman's computers for three days for 'forensic examination'; and Mr Reinert said that Eli Lilly has indicated that it wants to seek 'all possible sanctions' against Dr Egilman. The consequences, Mr Reinert said, 'could be very severe' and could conceivably extend to compensatory damages and time in jail.

Mr Gottstein said that Eli Lilly has also warned him of possible 'disciplinary action at the bar.'

Eli Lilly, in email messages to the BMJ, states that it is pursuing action because 'these individuals have violated a federal court order by leaking the documents' and that it has not released its internal documents publicly because the company 'has no intention of violating that order by releasing documents ourselves.'

It added, 'We intend to try the remaining cases in court—not in the news media.'

Eli Lilly also states that 'documents that have been illegally leaked to the New York Times are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly's conduct.'

The leaked documents, says the company, were "only a few hundred of the 11 million pages" and had been "carefully selected by the ‘leakers' to tell a story that the ‘leakers' want them to tell."

Eli Lilly's statement to the BMJ continued: 'These documents do not in any way represent an accurate view of Lilly company strategy or activities. What these individuals are not likely to show you is the millions of other pages of documents demonstrating how Lilly and its employees have worked to improve the lives of people with schizophrenia and bipolar disorder.'

This is a chilling development. It seems to me that patients, physicians, and the public ought to know whether Lilly marketed Zyprexa honestly, or whether it sought to deceive, and particularly whether it sought to suppress or manipulate data from trials on patients who thought that the information about them was to be used for the advancement of science, not commercial marketing purposes.

Lilly, of course, has a right to explain its actions, and defend itself from any allegations about its conduct.

But for a drug company to threaten whistle-blowers with "very severe" sanctions, including jail time, in a case like this does not exactly inspire confidence in their commitment to transparency, or to putting the welfare of patients, particularly patients in drug trials, ahead of marketing concerns.

Are You Ready for Some Football (and More)?

Well, it's that time of year again, the run-up to the Super Bowl in the US. So in that spirit, use this link to view the blog's All-Pharma Cheerleading Squad. This includes pictures and links to biographies of 16 lovely ladies who are both pharmaceutical representatives and cheerleaders for professional US football teams. The blog noted that there are probably more candidates for this squad, since some team sites do not list the professions of their cheerleaders.

We posted last football season about how pharmaceutical companies were beginning to view former cheerleaders as ideal candidates to be pharmaceutical representatives. The explanation had to do with enthusiasm, of course.... But one cannot help but wonder whether the pharmaceutical marketing folks perhaps had some other characteristics in mind.

That suspicion is raised further by the recent designation of Ms Donna Chiafair, another pharmaceutical representative, as Miss FHM for 2006. FHM is a men's magazine known for publishing revealing pictures of attractive young women. The relevant press release is here. For those interested, a Google search might be much more, shall we say, revealing.

This is all good fun, of course, but raises again questions about how far pharmaceutical companies are willing to go to market their products, and the extent that marketing has taken precedence over science and concerns about patients welfare among their leadership.

Hat tip to PharmaGossip for both stories (here and here).

Contrasts and Contradictions in How Right- and Left-Wing Politicians Address Pharmaceuticals and Medicare

After actually being able to write about positive developments in health care on Health Care Renewal (see post here), it's back to business as usual.

The current debate in the US Congress about the how the Medicare (government single-payer insurance for the elderly and disabled) program pays for pharmaceuticals has brought out some interesting contrasts and contradictions on both sides of the debate.

Democrats, who now control Congress, are proposing a revision of the program. As reported by the AP (via the San Diego Union-Tribune),

Currently, private drug plans negotiate how much they'll pay for the medicine their customers take. But the legislation under consideration Friday would require the secretary of the Department of Health and Human Services to do so.

'It is clear Medicare can do better and we are insisting that they do so,' said Rep. John Dingell, D-Mich., the bill's author.

The Republican counter-argument was conveyed in a statement from the White House,

Government interference impedes competition, limits access to lifesaving drugs, reduces convenience for beneficiaries and ultimately increases costs to taxpayers, beneficiaries and all American citizens alike.

This argument against allowing the government actually negotiate what it pays for pharmaceuticals on behalf of American citizens is similar to that made by many conservative pundits. They often have characterized negotiation as virtually the same as price controls. For a sample argument from today's Washington Times, go here.

Of course, the Medicare program also pays for hospital and physicians' services. And for many years, the government has simply imposed fees on the latter. This is one major reason that primary care physicians' income has fallen farther and farther behind inflation (see post here). For my argument that this is a wooden-headed reimbursement policy, see previous posts here, here and here.

But I not recently heard any conservative commentators decrying government "price-controls" on physicians' fees, even as such controls are driving primary care physicians out of business.

So why are Republicans and conservatives so worried about the government negotiating what it pays for pharmaceuticals, while they are perfectly happy for the government to impose fee schedules on physicians?

On the other hand, while the Democrats have proposed "negotiation," they "would ban any attempt to limit the array of drugs available to Medicare beneficiaries by creating formularies. That stands in contrast to the Veterans Administration, which has lower prices for its beneficiaries but uses formularies that limit patient choice." How the government could effectively "negotiate" prices without the power to refuse to pay for drugs whose prices were too high is unclear. The Democrats also would leave intact a controversial ban on the re-importation of drugs from other countries.

A Washington Post article suggested why the Democrats did not go further,

They stepped back largely out of concern that the pharmaceutical industry would stall a complex change, denying them a quick victory on a top consumer-oriented priority, aides say.

They had reason to be wary: Despite years of lopsidedly favoring GOP lawmakers with campaign cash and other benefits, the drug lobby continues to wield tremendous power in the Democratic-controlled Congress. It also still has the backing of the White House: President Bush said yesterday that he will veto the Democratic proposal if it lands on his desk.

To strengthen their position, drug firms and their trade groups have been transforming their Washington operations by hiring top Democratic lobbyists to gain access to new committee chairmen, bolstering Democratic political donations and spending millions on public relations campaigns to overcome an image, indicated in recent surveys, that the industry puts profits ahead of patients.

Even longtime industry nemeses like Rep. Fortney 'Pete' Stark (D-Calif.), chairman of a House health panel, are impressed. 'They're pretty potent,' he said this week. 'They're not bush-leaguers when it comes to spending money and lobbying.'

This month alone, the Pharmaceutical Research and Manufacturers of America spent more than $1 million on full-page newspaper ads touting the success of the existing Medicare drug system.

Drug companies spent more on lobbying than any other industry between 1998 and 2005 -- $900 million, according to the nonpartisan Center for Responsive Politics. They donated a total of $89.9 million in the same period to federal candidates and party committees, nearly three-quarters of it to Republicans.

'You can hardly swing a cat by the tail in Washington without hitting a pharmaceutical lobbyist,' said Sen. Charles E. Grassley (R-Iowa), a key sponsor of the 2003 legislation that created the current program.

The drug industry lobbying effort started to tilt Democratic as soon as it was clear that Democrats were headed for victory in the midterm elections. The industry is working "to expand areas of contact, develop relationships with those who are in charge," said former senator John Breaux (D-La.), a lobbyist for the industry.

The political action committee of the drug company Amgen gave Rep. John Conyers Jr. (D-Mich.), the new chairman of the House Judiciary Committee, $8,500 during the 2006 election cycle, amounting to three-quarters of all its donations to him over the past decade. In the Senate, GlaxoSmithKline's PAC contributed $8,000 during the cycle to Sen. Kent Conrad (D-N.D.), the new Budget Committee chairman. That is more than the $6,000 total that the PAC had given to Conrad since 1997.

Helping lead the industry's charge is Breaux, the former senator, who is one of only two Democrats who played a role in drafting the 2003 bill. He said he plans to hopscotch the country holding public seminars on solving health-care problems, often in the states and districts of members of Congress who are pivotal to drug legislation. It is part of a program, called Ceasefire on Health Care, that is bankrolled by the drug company Pfizer and has featured speakers such as Sen. Blanche Lincoln (D-Ark.) and Sen. Gordon Smith (R-Ore.), who both sit on the Finance Committee.

'We need to get access to key Democrats now,' said former representative James C. Greenwood (R-Pa.), president of the Biotechnology Industry Organization, a prominent industry group.

So despite Democratic protestations that they are out to make Medicare "do better," whether the Democrats will end up much less cozy with the pharmaceutical and biotechnology industries than were the Republicans remains to be seen.

But all this talk about increasing industry access to the country's legislative leaders leaves out consideration of what sort of access the real people who are affected by this legislation have.

It's yet another example of concentration of power in health care, with the health care professionals, and the particularly the patients on the short end.

One Antidote for Wooden-Headed Reimbursement

We have discussed (here and here) wooden-headed reimbursement policies in health care, and the perverse incentives they offer. Reimbursements made by insurance companies/ managed care organizations and government agencies in the US are rarely related to the perceived values of the reimbursed services or goods to patients, the benefits versus harms provided by the goods or services, or the costs of making the goods or providing the services. Instead, reimbursement generally tends to be higher for newer, more "high-technology," and procedural goods and services. Furthermore, the amount paid to physicians and other health care professionals to talk to, examine, and think about patients in order to make the best possible decisions on their behalf falls ever farther behind inflation.

The Wall Street Journal just reported a possible antidote for these sorts of wooden-headed reimbursement policies. To summarize, Aetna Inc., a large managed care organization, confronted the leadership of Virginia Mason Medical Center (a major academic medical center in Seattle) with its high costs compared with other hospitals. The Virginia Mason leadership was open to making changes, and developed a team approach to streamline its services. Resulting innovations included a simplified method for handling lower back pain, emphasizing, as per the best available evidence, early physical therapy for uncomplicated cases; starting patients with gastroesophageal reflux disease (GERD) when possible on generic drugs, which are generally as effective as brand-name drugs for this condition; and increasing the provision of "rescue" drugs for recurrent migraine headache to patients with this problem .

But these innovations, although they lowered costs and seemingly were good for patients, hurt Virginia Mason's bottom line. For example, "the big employers saved $100,000 in the first year. But Virginia Mason fell into the red on the average migraine case, instead of breaking even as before."

Amazingly enough, Aetna was understanding. "A novel solution, crafted with the help of the big employers, ultimately let Virginia Mason share in some of the savings it created -- by paying the medical center more for some cheaper treatments."

As the article noted,

Insurers often reimburse high-tech procedures richly, while simpler remedies and visits to doctors, therapists or nurses earn far less and sometimes incur losses. With each MRI that Aetna and the employers avoided at around $850, Virginia Mason lost about $450 in profit. The payment system of government-sponsored Medicare, which private health plans also use as a template, tends to reward the big capital expenses of buying high-tech machines such as MRIs. The more the machines are used, the bigger profit margin they pack. Meanwhile, reimbursement fees for doctors' visits have stagnated.

'The payment system is so toxic,' says Francois de Brantes, a former health-care program director at General Electric Co. 'Unless you tackle it, any health-care reform doesn't have much chance.'

The big problem, however, is that Aetna only accounts for about 10% of Virginia Mason's revenue. So,

Virginia Mason's move is a gamble. Only Aetna, which accounts for 10% of the medical center's business, has adjusted fees to reward its more efficient care. Seattle's two biggest health insurers, Regence Blue Shield and Premera Blue Cross, haven't matched the move so far. Medicare, despite its own experiments, doesn't have the flexibility to change its payments for one hospital -- and it accounts for a third of Virginia Mason's business.

Thus, it is not clear whether this radical experiment will work. It does demonstrate that some clear, honest thinking exercised simultaneously amongst health care professionals, leaders of academic medical centers, insurers, and employers can come up with reasonable solutions to wooden-headed reimbursement. Of course, such solutions may rapidly become unpopular with those who will make less money as a their result.

But give the Aetna, Virginia Mason, their leaders and health care professionals, and local employers a lot of credit for clear thinking and the willingness to go against the prevailing dogma.

Wednesday, January 10, 2007

Big Pharma Allegedly Advocates Continuing Tenure of Spokesperson Who Admitted to Obstructing Justice

The Boston Globe reported on a conflict among the members of the Massachusetts Biotechnology Council about whether to fire its president. The president was Thomas M Finneran, a former state legislator and Speaker of the Massachuetts House of Representatives. In a plea bargain, Finneran admitted guilt to obstruction of justice charges arising from his testimony during a civil lawsuit about legislative redistricting.

According to the Globe, here are the issues in the dispute about Finneran's tenure on the Biotechnology Council,

The debate over Finneran highlights a division in the state biotechnology industry. On one side stand a handful of large companies with products on the market and frequent business before Congress, which can influence drug regulation and pricing. On the other side are the hundreds of smaller companies, most without profits or approved products, which rely on the council for purchasing discounts, networking, and support for state-level issues such as zoning and research grants.

Executives of the smaller companies say that biotechnology values its reputation as a clean, research-driven industry, and are concerned that Finneran's felony could stain that image.

But large pharmaceutical companies, which need Congress to reauthorize key legislation on prescription-drug approvals this year, are concerned about alienating Finneran's friends in the Legislature and on Capitol Hill.

Of the 21 members on the council's board, four represent major pharmaceutical companies: Pfizer Inc., Novartis AG, Wyeth, and AstraZeneca. Representatives of those companies either could not be reached or would not comment on their votes last night. But a person close to one of the companies' board representatives said it was likely that three, and possibly all four, of the firms' representatives would support Finneran.

In our recent Health Wonk Review post, we cited a fellow blogger who commented on differing perceptions of the pharmaceutical industry among its executives and the public. Here is an example of what may be driving the public's (and physicians') skeptical perceptions about the industry. Doesn't advocating a confessed felon, and an obstructor of justice at that, to continue as a top industry spokesperson, as the Globe alleged, suggest a management approach that is badly ethically challenged?

Maybe pharmaceutical industry executives could convince people they are "well-meaning" if they at least were to restrict their spokespeople to those who have not been convicted of felonies.

ADDENDUM (1/11/2007) According again to the Boston Globe, Finneran has quit his job with the Biotechnology Council, and was promptly hired as a host on talk radio. He also was quoted that despite pleading guilty to obstruction of justice, when he looked back on his time served in the state legislature, he felt he "would not change a thing."

On the Performance on the Ground of One Supposedly "Brilliant" CEO's Company

One of our blogging colleagues, as we summarized in the Health Wonk Review, discussed differences in perceptions about pharmaceutical companies among their executives and the public at large. There also seem to be some differences in perceptions about for-profit managed care organizations as well.

Take UnitedHealth Group, (please.) We had posted about the gushing support its former CEO, Dr William McGuire, got from the board of directors who was supposed to be supervising him. In particular, we quoted the following from a Wall Street Journal article, "'We're so lucky to have Bill,' says Mary Mundinger, a UnitedHealth director who sits on the company's compensation committee. 'He's brilliant.' She says his income gives him extra credibility in health-policy debates because it shows his success. 'He needs to be compensated appropriately so that his business model has believability in the market,' says Ms. Mundinger, who is dean of the nursing school at Columbia University."

Later, the Pioneer Press reported about how Ms Mundinger's role on the UnitedHealth board might have conflicted with her role as Professor and Dean of Nursing at Columbia University. (See post here.) And later still, or course, the "brilliant" CEO Dr McGuire was forced to resign because of a scandal involving the back-dating of the over one billion dollars worth of stock options he had received from the company. (See post here.)

Now, it turns out, as per a report from AP (via the Fort Worth Star-Telegram), that the management of UnitedHealth while Dr McGuire was in command was not perceived as so "brilliant" by state regulators. There have been particular issues in Nebraska, as we have posted before.

UnitedHealthCare Group violated 18 Nebraska insurance laws hundreds of times during a review period, state insurance regulators say.

In a Nebraska Insurance Department petition, the department said UnitedHealthCare had more than 800 violations, mostly for its handling of claims, from July 1, 2003, through June 30, 2004.

UnitedHealthCare spokesman Gary Thompson said the company was taking the complaints seriously and has seen a decline in them.

'We have cooperated fully with regulatory agencies' examinations and reviews and consistently strive for effective solutions to improve service and monitor our own performance,' Thompson said.

Insurance Department attorney Ann Frohman said Monday that a surge of complaints prompted a department review starting in March 2003.

State examiners met with UnitedHealthCare officials, who said they would fix the problems, which persisted, the department said.

In 2005, UnitedHealthCare agreed to settle claims complaints by paying fines of $62,500 and $10,000.

Complaints continued last year, the department said, about claims for chiropractic treatments, mental health, newborn baby care, gastric bypasses and other medical procedures.

Among the company's failures, as cited by the department, were decision delays, wrong decisions about coverage and bad information given to consumers.

The department also said UnitedHealthCare didn't turn over accurate or timely information to the state, didn't have an adequate network of emergency services or mental health and substance abuse treatment in rural areas and didn't provide current lists of its care providers.
While some health care CEOs may be viewed as "brilliant" by their admirers on their companies' boards, the performance of their companies on the ground may often be far short of "brilliant."

Health care organizations would benefit from leadership that is not so insulated from the realities of the world.

Health Wonk Review Hosted This Week on Health Care Renewal

Welcome to Health Care Renewal. We are a multi-author blog which focuses on external threats to health care's core values, especially those due to concentration and abuse of power. Please feel free to browse our main page and archives.

We are proud to host this edition of the Health Wonk Review.

[Addendum 1/11/2007 - Please note - the original version of this post had several weirdly scrambled links. Also, the version put up by Google seemed to have entirely lost one of my citations. In some cases, the link appeared correct in HTML, but was scrambled in the posted version. I have tried to fix all of these problems. If anyone notices any more bad links, please email me a rposes at firmfound dot org. I also added two more citations, one whose submission was lost in the spam filter. Sorry about all that and thanks for the corrections.]

Access and Insurance

On the old version of the Health Business blog, David Williams argued that the rich are not given exceptional health care.

And on the new Health Business blog site, David Williams wondered what the very long wait currently required to see a dermatologist in Boston has to say about the usual arguments (long queues in Canada) against a single-payer health insurance system.

Mike Feehan, on InsureBlog, suggested that the rising prevalence of uninsured patients is an indictment of Medicaid, the US state-federal health care system designed for people who can't afford health insurance.

Jason Shafrin, on the Healthcare Economist blog, reviewed Governor Schwarznegger’s plans for universal health insurance in California, and wondered if they will save costs.

Joe Paduda, on Managed Care Matters, suggested that health care economics is of the “supply-side” variety.

Jon Coppelman, on the Workers’ Comp Insider blog, discussed why health care provided under workers’ compensation insurance costs so much.

Leif Wellington Haase from the Century Foundation , suggested why the idea of universal health insurance may be becoming more appealing today.

James Gaulte, on the Retired Doc’s Thoughts blog , noted the disparity between how rigorously the US Federal Trade Commission (FTC) enforces anti-trust regulation to prevent even small groups of physicians from talking about fees, but ignores how a few large health care organizations, such as hospitals or insurers, may dominate local or regional markets.

And regarding the power of a few large insurers, Graham, on the Over My Med Body blog , described the many reasons California insurers find not to write individual policies for individuals with often trivial diseases, or with “dangerous” jobs.

Matthew Holt, on the Health Care Blog, stirred up some controversy by suggesting that the amount spent on the late US President Ford's medical near the end of his life was inappropriate.

Health Care Management

Marcus Newberry, on the Fixin’ Healthcare blog , suggested that as long as health care is a business focusing on disease, things will not improve.

Information Technology

Shahid Shah, on the Healthcare IT Guy blog, had an invitation for health care bloggers to meet in person at the HIMSS '07 conference in New Orleans.

Pharmaceuticals and Biotechnology

Erik Turkewitz, on the New York Personal Injury Law Blog, had an update on counterfeit drugs.

HS Ayoub, on the BioHealth Investor blog, chronicled the tale of a former drug “pirate” in India which is now going into the international generic drug business.

Paul Howard, on Medical Progress Today, argued that, based on the European example, direct negotiation of drug prices by the US government would stifle innovation.

On the other hand, David Harlow, on the HealthBlawg, suggested points in favor of Medicare negotiating drug prices.

Adam Fein, on the Drug Channels Blog, discussed implications of the Cardinal Health settlement and the issue of counterfeit drugs.

Fard Johnmar, on the Envisioning 2.0 blog , discussed differences in how consumers and pharmaceutical company executives view the industry. He saw pharmaceutical executives as mainly well meaning, but having to cope with an onslaught of negative publicity about the industry. Readers should peruse some of the stories about some of the leadership of the biotechnology and pharmaceutical industry on Health Care Renewal, and think about just how well-meaning they have been, and whether some of the bad publicity was not deserved.

In that vein, Merrill Goozner, on GoozNews blog , noted how the world’s most famous medical journal “de-fanged” an article about conflicts of interest affecting guideline development, in this case, how one large biotechnology company helped to fund the development of guidelines that, surprise, suggested aggressive use of one of its expensive products.

DB, on DB's Medical Rants, discussed the pheonomenon of "too many diagnoses," otherwise know as disease mongering.

“Jack Friday,” on the PharmaGossip blog , announced the debut of the PharmedOut web-site, devoted to teaching physicians more about misleading practices used to market pharmaceuticals.

The Clinical Psychology and Psychiatry blog , commented on how at least one academic physician who worked on trials sponsored by a pharmaceutical company was willing to admit he withheld data from the trial that was unfavorable to its sponsor, and advocated that “industry and academia need to get out of their shared bed.”

Finally, Aubrey Blumsohn, on the Scientific Misconduct blog, chronicled his continuing efforts to get the original data from a drug study for which he was the principal investigator, yet which was withheld by the study's sponsor. This case, which is not well known outside of the UK, is a chilling reminder of how the supposed sponsors of drug trials may try to influence clinical science.

Quality and Safety

On the Antidote: Counterspin for Health Care and Health News blog, Emily DeVoto reviewed recent evidence that the sort of health care quality measures often proposed for pay-for-performance systems for doctors do not seem to correlate very well with some important clinical outcomes.

Rita Schwab, on the MSSP Nexus blog, argued that interviewing physicians for medical staff positions involves medical safety issues.


We have been delighted to be able to showcase some of the lively discussion of health care policy going on in the blogsphere. We hope it has provided food for thought.