Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

conflicts of interest GlaxoSmithKline medical organizations obesity Sanofi-Aventis

Gusty 11:08 Add Comment

Stephanie Saul in the New York Times, and Karl Stark in the Philadelphia Inquirer have covered the curious story of the downfall of the president-elect of the Obesity Society. Last month, Ms Saul set the stage,

New York City�s new rules for menu labels at chain restaurants have set off a food fight among the nation�s obesity experts.

Most support the theory of the city�s health commissioner that forcing chain restaurants to list the calories alongside menu items � flagging that a Double Whopper With Cheese has 990 calories, for example � will make patrons think twice about ordering one. The rules are set to take effect at the end of March.

There is a countertheory, however, set forth by Dr. David B. Allison, the incoming president of the Obesity Society, a leading organization of obesity doctors and scientists. An affidavit he recently submitted to the United States District Court for the Southern District of New York has ignited a controversy within his organization.

In the filing, Dr. Allison argues that the new rules could backfire � whether by adding to the forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more.

It might be only a scientific debate among nutrition experts, except for the fact that Dr. Allison was paid to write the document on behalf of the New York State Restaurant Association, which is suing to block the new rules.

Dr. Allison�s role in the debate has angered some members of the Obesity Society, setting off an e-mail fury since word of his court filing began to circulate. Some have pointed to Dr. Allison�s other industry ties, which have included advisory roles for Coca-Cola, Kraft Foods and Frito-Lay.

Many of the group�s 1,800 members are �completely mad that a president-elect of the Obesity Society, an organization that cares about obesity and cares about healthy eating, wants to hold back information from people that helps them make healthy choices,� said Dr. Barry M. Popkin, a member of the organization, who is director of the Interdisciplinary Obesity Center at the University of North Carolina, Chapel Hill.

Dr. Allison, a professor of biostatistics and nutrition at the University of Alabama, Birmingham, is scheduled to start a one-year term as president of the Obesity Society in October. He has defended his affidavit. In a telephone interview, he said he did not take a position for or against menu labeling in the document but merely presented the scientific evidence that the labeling might deter over-eating but might not and, in fact, might be harmful.

He also defended his work for the restaurant industry, but would not disclose how much he was paid for his efforts.

�I�m happy to be involved in the pursuit for truth,� Dr. Allison said. �Sometimes, when I�m involved in the pursuit for truth, I�m hired by the Federal Trade Commission. Sometimes I help them. Sometimes I help a group like the restaurant industry. I�m honored that people think my opinion is sufficiently valued and expert.�

The executive vice president for the restaurant association�s metropolitan New York chapters, E. Charles Hunt, said that Dr. Allison was retained by the association�s lawyers. �Obviously, a lot of it was in favor of our position,� Mr. Hunt said, �although he didn�t come right out and say that.�

So this sounds like yet another story about conflicts of interest, and their possible effects influencing the publicly expressed opinions of a prominent academic. As usual, the conflicted party angrily denied that his financial relationships could have affected his scientific judgment. As we have noted before, this is undoubtedly a sincere belief, but psychological evidence and common sense suggests that having financial ties to organization x may influence one to take positions in line with organization x's interests, even if these influences do not reach conscious thought.

The variant here seems to be that the academic had a financial relationship not with a drug, biotechnology or device company, the usual suspects, but with an association of restauranteurs.

But wait, Mr Stark added more in his story in the Philadelphia Inquirer,

The relationship between academic researchers and industry is a front-burner issue in many fields. Several congressional inquiries are looking at drug-firm support for the American College of Cardiology, the national cardiology group, and the American Heart Association.

Compared with those groups, the Obesity Society, based in Silver Spring, Md., would seem like a tiny outpost with its $2.1 million budget. But the group's 1,800 members include many influential researchers, physicians and dietitians.

The society relies heavily on industry money, raising about $1 million in the last year from various companies, said Morgan Downey, the group's executive vice president. The biggest corporate donors were drugmakers sanofi aventis, GlaxoSmithKline and Allergan as well as the health-care conglomerate Covidien, he said.

About $230,000 of the corporate money funded a conference in September for health advisers to presidential candidates, Downey said.

Fast forward to this week, when Ms Saul reported in the New York Times that Dr Allison is giving up his leadership position for the Obesity Society,

A dispute over food industry influence has resulted in the resignation of the incoming president of the Obesity Society.

Dr. David B. Allison, who was to take over the society, a national group of obesity doctors and researchers later this year, submitted his resignation from that position on Friday.

So what happened? Did the Obesity Society cast out a leader because he had conflicts of interest that interfered with his ability to advance science, education and clinical practice? Or did the Obesity Society cast out a leader because he was aligned with commercial interests opposed to the commercial interests that provide most of the society's support? That is, was he cast out not because he had conflicts of interest, but because he did not have the same conflicts of interest as the society?

Who can tell?

Once again, this case is an illustration of the pervasiveness of conflicts of interest affecting health care organizations. It also shows how the pervasiveness of such conflicts sometimes makes it impossible to discriminate debates about science and health policy from the claims of conflicting pitchmen.

Full disclosure of these conflicts beforehand would at least have given warning that the nature of the debate was ambiguous.

But to figure out the best answer in the current policy debate, that is, whether it really is a good idea to have legislation to put calorie counts on restaurant menus, would really require the input from people who are not paid by either restauranteurs, or those selling obesity treatments. Fat chance that will happen soon.

Princess Health and Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues. Princessiccia

Princess Health and Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues. Princessiccia

anechoic effect crime power elite UMDNJ

Gusty 07:57 Add Comment

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university was operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) More recent were some reports of amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). There was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). We found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here), and that the monitor found even more bizarre financial practices at the university (see post here). Although the monitoring ended this year, his most recent report found previously undisclosed problems with the university's research compliance (see post here).

Over a year ago, it was reported (see post here with links to previous posts) that UMDNJ gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Last week, the Newark Star-Ledger provided some f0llowup,

Two cardiologists yesterday admitted signing on to high-paying, no-show jobs at the state's medical university in return for funneling patients to the school's troubled heart surgery program.

As part of the kickback scheme, the two were hired as clinical assistant professors at the University of Medicine and Dentistry of New Jersey, despite having no research credentials. They gave no lectures, taught no classes and acknowledged that they essentially did nothing more than refer patients for cardiac procedures while receiving hundreds of thousands of dollars in salary over three years.

The doctors -- Bakul Desai, 52, of Livingston and Laxmipathi Garipalli, 59, of Colts Neck -- are cooperating with the U.S. Attorney's Office and the FBI in a two-year criminal investigation that so far has implicated more than a dozen other part-time cardiologists and several top UMDNJ administrators. The scheme was hatched as part of an increasingly desperate effort to beef up a failing cardiac surgery program then on state probation, according to court records and reports by a federal monitor.

No university officials or any other physicians have been charged, although UMDNJ's chairman of medicine was forced to step down after the initial revelations became public.

In proceedings yesterday before U.S. District Judge Stanley R. Chesler in Newark, the doctors pleaded guilty to embezzling approximately $840,000 in payments from the university. The physicians stood quietly, answering questions with simple 'Yes' or 'No' answers. Both face possible jail time and suspension or revocation of their medical licenses.

U.S. Attorney Christopher Christie said others will be held accountable.

'UMDNJ has a culpable role in all of this,' Christie said. 'Don't take from these two guilty pleas today (the idea) that the institution itself is off the hook, because I will say quite clearly it is not.'

A university spokeswoman said UMDNJ and its board have 'worked aggressively' to restructure and reform the community cardiology program since concerns were first raised in 2006, including a reduction in the number of community cardiologists and changes in salaries and reporting requirements.

Desai and Garipalli should have known from the start that they were taking money for doing nothing, Christie said.

'They continued to do nothing and they continued to get paid in what is a classic New Jersey no-show government job scam,' Christie said during a news conference afterward. 'Extraordinary fraud and waste and abuse and illegality that was occurring with public money at UMDNJ.'

So here is even more documentation about the muck in which UMDNJ is mired.

We will wait and see whether there are more criminal charges in this case. In cases of health care corruption, it often seems that any penalties incurred affect those lowest on the totem pole, in this case, the two unfortunate cardiologists. Those higher up all too often get to walk away. This suggests how health care has come to be run by a power elite that do not have to follow the rules to which mere mortals are subject. I hope Mr Christie is able to buck this trend.

In the UMDNJ case, it seems obvious that someone in the management of UMDNJ had to have been involved in this scheme. It is hard to see how it could have occurred otherwise. So we wait and see if any such people are identified, much less convicted.

Another striking feature of the UMDNJ case is its manifestation of the anechoic effect. I put in a fairly long summary above at the beginning of this post emphasizing the magnitude, importance, and complexity of this case. I did so because many people, including many health care professionals and health policy makers, may be totally unfamiliar with the UMDNJ case. It has only been discussed in the news media in New Jersey (and to some extent the neighboring states of New York and Pennsylvania) and in Health Care Renewal. It has not, repeat not ever been discussed in any medical, health care, health services research, or health policy journal. It has not, repeat not appeared in any prominent medical. (I repeated the relevant searches today, of Medline, Google Scholar, and of the American Medical News, JAMA, and MedPage.)

An entire health care university admitting guilt, being subject to a deferred prosecution agreement, operating under a federal monitor, while all sorts of mismanagement and unethical behavior were uncovered, and NO ONE thinks it is worthy of discussion in any medical, health care, health services research, or health policy journal or newsletter?

The anechoic effect lives. And as long as it lives so vigorously, we make no progress in attacking the pervasive mismanagement, conflicts of interest, and outright corruption afflicting the management of health care. If we cannot even talk about these problems, how are we going to solve them?

Talking about them, however, might disturb the power elite that personally profits so much from their domination of health care. Hence, most health care professionals who are lower in status realize that to even mention such topics in public is to imperil one's career.

But as long as we cannot discuss the recent unpleasantness, things will continue to get even more unpleasant.

Fight the anechoic effect. Take back the future.

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

free speech intimidation medical devices

Gusty 14:11 Add Comment

Posts on the Wall Street Journal Health Blog, the Clinical Psychology and Psychiatry Blog, and by Dr Aubrey Blumsohn on the Scientific Misconduct Blog all picked up on a brief story in the Harvard Crimson about a lawsuit apparently claiming that a clinical research article, and a randomized controlled trial no less, was defamatory. Here is the gist from that news article,

Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).

In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.

HipSaver�s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel�s study to be applied to hip protectors in general.

Robert L. Hernandez, who is representing HipSaver, described Kiel�s article as 'disparaging' and 'grandiose.'

Actually, as quoted by Dr Blumsohn, the JAMA article's conclusions were framed in the typically measured terms of clinical research reports.

In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

[See Kiel DP, Magaziner J, Zimmerman S et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298: 413-422. Link here.]

Of course, if these conclusions were libelous, than practically any scientific article could be considered libelous.

Equally obviously, HipSaver leadership have a perfect right to criticize the Kiel article. But to sue the authors because the company disagrees with their conclusions could have a chilling effect on science. This lawsuit seems to be a deliberate effort to intimidate clinical scientists who dared to collect and publish data which suggesting that commercial products may not be as wonderful as their marketers claim.

If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe.

Furthermore, this lawsuit can be construed as an attack on basic human rights in the US context. In this context, it appears to be a SLAPP, that is, Selective Litigation Against Public Participation. This term was coined to describe lawsuits designed to intimidate people from speaking out about issues of public interest (but in a way that might threaten vested interests.) For more information about SLAPPs, see the SLAPP Resource Center. Also see this article from the First Amendment Center.

Most US states, including Massachusetts, have laws that allow SLAPPs to be countered. For example, in Massachusetts, the law provides (see the SLAPP Resource Center), ]

Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys� fees shall be awarded to a victim prevailing on the motion to dismiss.

I don't think it is too much of a stretch to apply the SLAPP concept to a lawsuit aimed at the free discussion of the effectiveness of treatments in health care, given that the government indirectly or directly pays for many of these treatments, and that determining the effectiveness of treatments is clearly a public health policy issue.

I fervently hope HipSavers withdraws this ill-conceived lawsuit. If the company persists, I fervently hoped its attempted SLAPP gets slapped down.

Here is another sorry example of how health care, particularly clinical research, is under seige by those with vested interests and private agendas.

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

conflicts of interest medical devices orthopedic surgeons

Gusty 13:48 Add Comment

Late last year, we posted (here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

Despite the obvious potential for these payments to influence practice, teaching, and research, the issue received almost no attention after the initial media reports. Last week, however, it created a few more ripples. As reported by Bloomberg News, via the Washington Post,

Four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants, a U.S. investigator told Congress.

The unidentified companies control about three-quarters of the $9.4 billion worldwide market for hips and knees, said Gregory E. Demske, an assistant inspector general at the Health and Human Services Department, at a hearing yesterday of the Senate Special Committee on Aging.

'Illegitimate' payments, the extent of which is unknown, influence orthopedic surgeons' medical judgment and are so common that it will be difficult to eliminate the practice, Demske and other witnesses said. The fees have enriched doctors and distorted the market by bolstering sales of lower-quality devices, they said.

'Industry and physicians are equally culpable,' said Sen. Herb Kohl (D-Wis.), chairman of the panel. 'Some physicians make it known to the companies that they will be loyal to the highest bidder. Where does the patient's well-being fit into the equation?'

Even an executive at one of the device companies admitted problems with the payments.

It's clear the device companies went too far, said Chad Phipps, Zimmer's general counsel.

'In hindsight it now appears that as the industry expanded to meet patient needs, the use of consultants may have been excessive at times,' Phipps told the committee.

In addition, a Minneapolis Star-Tribune story referred to

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to 'adult entertainment' clubs. Fat checks for what some see as questionable work.

And a Wall Street Journal story gave this example

In some cases, a company sales representative would spend one or two hours in an operating room watching a surgeon implant his company's device. The company would then pay the doctor for eight to 10 hours of 'training' services, according to findings that government investigators shared with the committee.

Maybe I shouldn't be amazed that this story has provoked so little response, much less outrage. Even though some academic orthopedists were getting literally millions of dollars a year (see this post), very few seem worried that such fabulous payments might have had some influence on their clinical decisions, on what they taught their students or colleagues, or on their research.

As noted before, some people are concerned by how physicians may be influenced by gifts of pens, coffee mugs, and pizza lunches. If we should be concerned about coffee mugs, how much more should we be concerned by multi-million dollar royalties or consulting payments?

But of course, it's easier to forbid coffee mugs and pizzas for medical students and house-staff than making the chair of orthopedics choose between his job and his multi-million dollar royalties.

Princess Health and The Spooky Stability of U.S. Health Care. Princessiccia

Princess Health and The Spooky Stability of U.S. Health Care. Princessiccia

Gusty 15:16 Add Comment

I only read last week a terrific commentary by Lawrence Brown in the New England Journal of Medicine�s January 24, 2008 issue on reform of the U.S. healthcare system and its chances. It�s titled The Amazing Noncollapsing U.S. Health Care System � Is Reform Finally at Hand?, and full text is available free to everyone.

Like Brown, I remember in 1993 when the punditry was pronouncing that health care reform was inevitable (it wasn't). I don�t remember (I was a kid) but have read health care panel discussions on policy from the 60�s amazingly reminiscent of today�s discussions about what an ever-increasing share of the GDP healthcare costs had become and how this was unsustainable. Brown�s article discusses the strong forces that make for stability in our very problematic healthcare system.

DemfromCT at DailyKos noticed the article promptly and commented.

Jeff Goldsmith at the Health Care Blog also comments, but I think takes the discussion in a completely wrong-headed direction by suggesting that this stability is benign. As Brown points out, it is far from that. This stability allows the continuance of the false complacency Americans so frequently have about �everybody getting healthcare� (despite poor kids and adults without asthma medication, cancer patients who can't get treated, lack of dental care and its toll in both physical and mental pain and infection, unavailability of rehab care and needed medical equipment, etc., etc.). It allows the continuance of an expensive idolatry of technology and of rampant, unnecessary, and harmful overtreatment [see Shannon Brownlee's excellent book on the topic of overtreatment]. It allows the continuance of a dangerous and patchy �non-system of care,� as Brown so rightly points out.

But as Brown also points out, the forces making for stability and non-collapse are powerful indeed. If you missed the article too, it�s well worth reading.

Princess Health and Pharma arguments and hogwash. Princessiccia

Princess Health and Pharma arguments and hogwash. Princessiccia

Gusty 14:35 Add Comment

The heparin manufacturing scandal sheds light on the typically rampant cynicism of U.S. Pharma arguments. When before the Medicare drug benefit there was a lot of pressure to allow importation of Canadian drugs, both sides were rather disingenuous in their arguments.

The pro-import side typically just presented it as an issue of competition and of not letting U.S. companies rip off U.S. citizens. What went unsaid is that what we were importing (and I thought it was in many ways an excellent idea) was not really Canadian drugs, but Canadian price controls. Since �price controls� is a four-letter word in the American lexicon, this was rarely stated.]

On their side and much more cynically, Pharma companies (with FDA complicity) stirred up fears about FDA approval and importation of allegedly dangerous �foreign drugs�. Unsaid was how many "American" drugs were really manufactured in whole or in part abroad (something I noticed at the time because I had run into shortages of prescribed asthma pharmaceuticals from time to time and had heard it was on account of problems at foreign factories).

The heparin scandal really points up big-time just how intellectually dishonest and cynical pro-Pharma arguments often are.

Princess Health and Heparin in an Era of Hogwash. Princessiccia

Princess Health and Heparin in an Era of Hogwash. Princessiccia

Baxter biotechnology FDA heparin Mismanagement mission-hostile management outsourcing pharmaceuticals

Gusty 14:21 Add Comment

Two weeks ago we first posted about an emerging scandal about the production of the drug heparin, a biologic that has been in use for over 70 years. First, we posted about the sudden increase in the frequency and severity of adverse effects due to heparin that carried the Baxter International label. However, its "active ingredient," that is, the heparin itself, was purchased from Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.

Last week, we posted about how the CEOs of Baxter International and Scientific Protein Laboratories did not seem aware of the origin of the heparin for which they were ostensibly responsible. Furthermore, it turns out its origin was not just Changzhou SPL, but a series of small, unregulated Chinese factories.

Since then, the plot has continued to thicken.

A congressional investigation is starting. Per the Wall Street Journal,

congressmen asked whether Baxter had known the Chinese plant hadn't been inspected and suggested the company might therefore be distributing an unapproved drug.

In a separate letter to HHS Secretary Michael O. Leavitt, the lawmakers asked for records relating to the FDA's preapproval inspection policy. They also sought an explanation of the agency's interpretation of the legal status of drugs shipped into 'United States commerce by a drug company that knew or should have known that FDA had not performed a preapproval inspection, as is alleged in the Heparin case.'

Chinese regulators dodged any responsibility. Again, per the Wall Street Journal,

China's drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.

The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, 'safeguarding the legality, quality and safety of active pharmaceutical ingredients' is up to importing countries.

The supply chain of heparin in China appears to be even more difficult to trace than previously reported. An investigative report published in the NY Times, first quoted the CEO of Scientific Protein Laboratories, Mr David Stunce, "we have a collection chain in place, and we stick with that." However,

But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain. The picture that emerges is of a chain more complex, and less orderly, than the one Mr. Strunce laid out.

The Chinese heparin market has become increasingly unsettled over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. Traders and industry experts say even big companies have been turning more often to the small village workshops, which are unregulated and often unsanitary.

One of the wholesalers named by Scientific Protein Laboratories, Ruihua Biochemical in Hangzhou, said it provided a mix of crude heparin that it manufactured and some that it bought 'from small factories nearby in several villages.' The owner, Hua Ruihua, said he never inspected the small factories. 'We are not the government,' he said in a telephone interview. 'We have no right to inspect their pigs or intestines or facilities.'

The owner of one of those workshops, Fan Yinan, said, I sold to Ruihua several times before, but since last September I have had no intestines.' He confirmed that 'no one from Ruihua inspected my pigs or intestines.'

Strunce's response was this non-denial denial, "we have no information to suggest your information is true."

Some heparin is produced in primitive and unsanitary conditions. The Times reporters also visited some small factories, whose operations do not exactly inspire confidence in the safety and purity of their products.

Some experts say as much as 70 percent of China�s crude heparin � for domestic use and for export � comes from small factories in poor villages. One of the biggest areas for these workshops is here in coastal Jiangsu Province, north of Shanghai, where entire villages have become heparin production centers.

In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.

The floors had large puddles and drainage channels; the workshops were dilapidated and unheated; and steam from the production process fogged up the windows and soaked the walls. There were large ovens to cook ingredients and halls lined with barrels to store enzymes, resins, intestines and wastewater.

'This is our family-style workshop,' said Zhu Jinlan, the owner of one heparin operation, who stopped sorting pig intestines and invited visitors to a back room, where she lives with her husband and child. 'We�ve been doing this about 10 years.'

Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.

'If you don�t control the incoming source, it�s very hard to get rid of the contaminants,' says Liu Jian, a heparin expert at the University of North Carolina.

Mr. Strunce of S.P.L. says his company never buys directly from the crude-heparin producers, only through its wholesalers, which he called 'consolidators' � Changzhou Techpool, its Chinese joint venture partner, and Ruihua. His company, he said, has records documenting all the transactions.

But here in Rugao, producers of crude heparin tell a somewhat different story. A sales manager for a major supplier, Nantong Koulong, said he sells directly to S.P.L. without going through either of the two wholesalers. 'We provided crude heparin to Changzhou SPL,' said the sales manager, Chen Jianjun. Some of Koulong�s stock comes from the unregulated workshops, he said.

The owner of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to S.P.L. two years ago. She also sells to Koulong. 'We are really a traditional family-style plant,' she said. 'We have no certificate.'

S.P.L. said it never bought directly or indirectly from Koulong.

The large companies cared more about getting heparin cheap than about where it came from. Again, according to the NY Times,

After an outbreak of blue ear pig disease swept through 25 of China�s 31 provinces and regions last year, prices soared, and many drug suppliers had to look to the small workshops. The epidemic, said Cui Huifei, a heparin expert at the Shandong University School of Medicine, 'made those biotech companies inevitably purchase from the family-style plants, for cheaper prices'

A sales manager for another large slaughterhouse in Shandong Province, north of Jiangsu, said he was approached late last year by a buyer for S.P.L. offering what he described as rock-bottom prices for crude heparin.

'It was impossible,' said the sales manager, Wang Shengfu, who works for Shandong Jinluo Group, a major producer of crude heparin. 'Only small factory-style farms could accept that low price.'

The deal was never consummated.

Wherever it gets its heparin, there were problems in the Changzhou SPL Plant. US Food and Drug Administration (FDA) inspectors finally got to the Changzhou SPL plant, and here is what they found, according to the Wall Street Journal,

Food and Drug Administration inspectors found problems at a Chinese plant that made most of the active ingredient for Baxter International Inc.'s blood thinner heparin, but the agency still hasn't pinpointed a cause for hundreds of bad reactions in people who took the drug.

Among other findings, the FDA said investigators found lapses in the Changzhou, China, manufacturer's quality-control procedures and the way it assessed its own efforts to remove impurities from raw materials.

The FDA also said yesterday it was seeking to examine upstream consolidators and small workshops that supplied raw material to the Changzhou factory. FDA inspectors found in its inspection report that some heparin sold in the U.S. included 'material from an unacceptable workshop vendor.'

Baxter International has recalled nearly all its extant heparin products, as reported in the WSJ article above.

Finally, the toll of serious adverse events linked to heparin has increased to 448, possibly including as many as 21 deaths. (See the same article.)

Health Care Renewal has documented numerous cases of financial mismanagement by leaders of health care organizations. We have discussed misleading marketing by drug, biotechnology and device companies, and by hospitals, academic medical centers, and health insurance companies. We have noted how medical education has been twisted into marketing, and clinical science has been manipulated, aided by pervasive conflicts of interest affecting physicians, academics, and various not-for-profit organizations.

But through all that, even I thought that the purity of the drug supply remained sacrosanct. Even I thought that no US or major multinational pharmaceutical or biotechnology company would sacrifice the purity and quality of the drugs they sold to cut their costs.

I may have thought that over-the-top marketing and shoddy research had inflated the benefit/ harm ratio of many drugs and devices. Up to now, however, I never doubted the purity of an FDA approved drug sold in the US with the logo of a reputable drug or biotechnology company.

In my previous academic life in which I spent a fair chunk of my time as an academic hospitalist, I often oversaw the use of parenteral heparin. I never would have suspected that the raw material in a vial of Baxter heparin came from some primitive, unsanitary, uninspected "family style" workshop in China.

We have reached a new low in US health care. The system is now mired in muck. We need a new generation of muck-rakers to clean it out. We need a total overhaul of the management of US health care organizations. We need managers who once again put patients before profits, and before lining their own pockets. Until things change, more people will die, and we will all eventually drown in the hogwash.