History > 2009 > USA > Health (I)

Mikhaela Reid

Cagle

16 January 2009

Op-Ed Contributor

Dead Body of Knowledge

March 27, 2009
The New York Times
By CHRISTINE MONTROSS

Providence, R.I.

AT the risk of sounding like a fuddy-duddy, I would like to say that sometimes, medical imaging isn’t all it’s cracked up to be.

As a resident in psychiatry, I depend on the technology to treat my patients. From countless computers in the hospital’s hallways and at nurses’ stations, I call up images of the people I treat: the black, white and gray CT scans of their skulls, the nuanced M.R.I.’s of their spinal cords and ligaments, the rotating Spect scans that show in three dimensions how well — or how poorly — blood flows through their brains. I can leave the room of an 89-year-old woman who has begun picking imaginary bugs out of the air, look into a screen, and see the tumor that is causing her delirium.

Now however, many medical schools are beginning to argue that imaging technology has improved to the point where it should be used in place of the dissection of human cadavers as the central tool of instruction for young doctors-to-be. This is a mistake. No matter how detailed and versatile they become, computer images can never provide the indelible lessons that novice doctors learn from real bodies.

Nearly every medical student in America begins his career by entering a room full of cadavers and taking one of them apart, layer by layer, piece by piece. Doctors have shared this experience for centuries, ever since Vesalius, Da Vinci and Michelangelo defied religion and government, stole bodies from graves and churches, and dissected by candlelight in an audacious pursuit of knowledge about the human body. The process is what you would expect: messy and smelly, tedious and time-consuming, emotionally and physically difficult. It is at times awe-inspiring, and at other times profoundly upsetting. It is also, for the medical schools, very expensive. Even though cadavers are donated, it can cost more than $2,000 to prepare a body for dissection.

So medical schools are beginning to re-evaluate their anatomy curriculum in the face of the perhaps inevitable argument: Why not reduce, or eliminate altogether, the burdensome cost of dissecting cadavers and replace it with this new and astounding technology? The computers and software — a considerable expense, but one that need be incurred only once — allow students to study images of the body from every angle and on every plane. They can peel away the muscle on a virtual leg to see the bone beneath, then click a different button, reattach the muscle and see how the limb moves.

Computers can show things that still and lifeless cadavers cannot — blood pumping in real time through the heart’s chambers, for instance. And it is far easier to visualize nerves and vessels when they’re color-coded on a computer than it is to pick through the indistinguishable gray-green tangles inside a formalin-embalmed cadaver. Because all of this can be done anywhere on any screen, students can study anatomy in this way in the library, in their apartments or, surely someday if not already, on their iPods and cellphones.

At the end of the academic year, there would be no need for old cadavers to be cremated, for new human donors to be found, for deep cleaning the anatomy lab. Come September, the whole system would simply reboot.

But what kind of doctors will they be, these students who have never experienced human dissection? They would have been denied a safe and more gradual initiation into the emotional strain that doctoring demands.

Someday, they’ll need to keep their cool when a baby is lodged wrong in a mother’s birth canal; when a bone breaks through a patient’s skin; when someone’s face is burned beyond recognition. Doctors do have normal reactions to these situations; the composure that we strive to keep under stressful circumstances is not innate. It has to be learned. The discomfort of taking a blade to a dead man’s skin helps doctors-in-training figure out how to cope, without the risk of intruding on a live patient’s feelings — or worse, his health. We learn to heal the living by first dismantling the dead.

The dissection of cadavers also gives young doctors an appreciation for the wonders of the human body in a way that no virtual image can match. It is awe-inspiring to hold a human heart in one’s hands, to appreciate its fragility, intricacy and strength.

But most important, the cadavers on their stainless steel tables are symbols of altruism to medical students: They are reminders of how great a gift one can give to a stranger in the hopes of healing. Isn’t that the most fundamental lesson we want our doctors to carry to the bedsides of their patients?

Christine Montross, a resident in psychiatry at Brown University, is the author of “Body of Work: Meditations on Mortality From the Human Anatomy Lab.”

Dead Body of Knowledge, NYT, 27.3.2009, http://www.nytimes.com/2009/03/27/opinion/27montross.html

As New Lawyer,

Senator Defended Big Tobacco

March 27, 2009
The New York Times
By RAYMOND HERNANDEZ
and DAVID KOCIENIEWSKI

The Philip Morris Company did not like to talk about what went on inside its lab in Cologne, Germany, where researchers secretly conducted experiments exploring the effects of cigarette smoking.

So when the Justice Department tried to get its hands on that research in 1996 to prove that tobacco industry executives had lied about the dangers of smoking, the company moved to fend off the effort with the help of a highly regarded young lawyer named Kirsten Rutnik.

Ms. Rutnik, who now goes by her married name, Gillibrand, threw herself into the work. She traveled to Germany at least twice, interviewing the lab’s top scientists, whose research showed a connection between smoking and cancer but was kept far from public view.

She helped contend with prosecution demands for evidence and monitored testimony of witnesses before a grand jury, following up with strategy memos to Philip Morris’s general counsel.

The industry beat back the federal perjury investigation, a significant legal victory at the time, but not one that Ms. Gillibrand is eager to discuss.

Now in the Senate seat formerly held by Hillary Rodham Clinton, Ms. Gillibrand plays down her work as a lawyer representing Philip Morris, saying she was a junior associate with little control over the cases she was handed and limited involvement in defending the tobacco maker.

But a review of thousands of documents and interviews with dozens of lawyers and industry experts indicate that Ms. Gillibrand was involved in some of the most sensitive matters related to the defense of the tobacco giant as it confronted pivotal legal battles beginning in the mid-1990s.

Ms. Gillibrand, who worked at the Manhattan firm of Davis Polk & Wardwell from 1991 to 2000, eventually oversaw a team of associate lawyers working on Philip Morris cases, according to a colleague, and was a frequent point of contact between the firm and Philip Morris executives.

In addition, Ms. Gillibrand represented Davis Polk on a high-level Philip Morris committee whose work included shielding certain documents from disclosure, according to several lawyers and industry observers. Serving on the panel placed her alongside some of the country’s top tobacco industry lawyers.

And she was viewed so positively by Philip Morris that by 1999, when the tobacco maker brought in an additional outside law firm to represent its interests, Ms. Gillibrand was one of five Davis Polk lawyers designated to train the firm about sensitive legal issues, according to a company memo.

When she moved in 2001 to a new firm, Boies Schiller, where she worked until 2005, one of Ms. Gillibrand’s clients was the Altria Group, Philip Morris’s parent company, where she helped with securities and antitrust matters, according to the firm.

Ms. Gillibrand, 42, a former upstate congresswoman who is still unknown to many New Yorkers and is preparing to defend her Senate seat in an election next year, is reluctant to discuss her work on behalf of the tobacco company. After initially agreeing to be interviewed by The New York Times, the senator canceled through her spokesman, Matt Canter, who said that focusing on Philip Morris would not reflect the range of her work as a lawyer, which also included representing pro bono clients, including abused women and families contending with lead paint in their homes..

“Senator Gillibrand was serving as a young associate when she was assigned this case,” Mr. Canter said. “It is a small part of her 15-year legal career.”

He stressed that like other tobacco lawyers, she was not at liberty to discuss her work for Philip Morris because of attorney-client privilege.

But those who recall Ms. Gillibrand’s days as a young lawyer say she was capable and eager as she plunged into the high-stakes and lucrative world of tobacco defense work.

“The client was always in her office,” said her former Davis Polk colleague Vincent Chang, who spoke glowingly of Ms. Gillibrand. “She was probably accorded more responsibility than the average associate by far.”

Of course, many lawyers, including some who now serve in the Senate, have defended unpopular clients. Still, in an approach that was not uncommon at law firms that represented tobacco companies, lawyers at Davis Polk were permitted to decline work on the tobacco cases if they had a moral or ethical objection to the work, Mr. Chang said.

Asked whether Ms. Gillibrand had any misgivings about representing the tobacco company, Mr. Canter responded by e-mail: “Senator Gillibrand worked for the clients that were assigned to her.”

Ms. Gillibrand was never the lead lawyer on the tobacco cases, which at Davis Polk drew on the work of dozens of lawyers and staffers. Robert B. Fiske Jr., a former Whitewater prosecutor and a Davis Polk partner, was the top lawyer among the approximately 20 at the firm working on the Philip Morris defense on the perjury case. Ms. Gillibrand’s hourly rate — $305 in 1995 — put her in the middle range of reimbursement for associates on the case, according to a tobacco industry document.

Mr. Fiske declined, through the senator’s office, to be interviewed about her work for Philip Morris, but released a statement calling Ms. Gillibrand “smart, hard-working and thoughtful.”

During her most recent congressional race, Ms. Gillibrand, who is a former smoker, accepted $18,200 in campaign donations from tobacco companies and their executives — putting her among the top dozen House Democrats for such contributions. Many Congressional Democrats do not accept tobacco money.

Mr. Canter said the senator should be assessed based on her record in Congress, where she has voted against the industry’s interests on several occasions, including supporting cigarette tax increases to help expand children’s health care.

And Todd Henderson, an assistant professor at the University of Chicago Law School, argued that it would be unfair to assess lawyers by whom they represent. “Nobody would want to live in a world in which lawyers are judged by the clients they take,” he said.

Limiting Evidence

A scion of a prominent Albany political clan, Ms Gillibrand graduated from law school at the University of California, Los Angeles, in 1991 and took a job at Davis Polk, a firm that had worked closely with the tobacco industry for decades.

Ms. Gillibrand was working at the firm during critical years for the tobacco industry, as the public tide was turning against smoking, and leading Democrats in the Clinton administration and Congress pushed for a more aggressive stance toward cigarette companies. At the same time, plaintiffs’ lawyers were beginning to chip away at the industry’s time-tested legal strategies.

In 1994, executives of the nation’s largest tobacco companies, including Philip Morris, prompted anger and disbelief when they swore before Congress that they did not believe smoking was addictive or that there was a proven link between smoking and cancer.

That appearance intensified criticism of the industry and scrutiny by federal prosecutors and ultimately led to a broad criminal investigation by the Justice Department into whether the executives had perjured themselves.

The government sought reams of internal company records to determine whether the tobacco executives had lied. There is no indication that Ms. Gillibrand ever discussed the case with William Campbell, then the Philip Morris president and chief executive, who was among the subjects of the perjury inquiry. But Philip Morris internal records show that the company’s top lawyers entrusted her with several essential elements of the case.

As a member of the Eastern District of New York Subpoena Working Group, Ms. Gillibrand helped limit what evidence the government obtained. She also monitored the testimony of witnesses who appeared before the grand jury and wrote strategy memos to the Philip Morris general counsel, Ken Handal, analyzing the witnesses’ statements and their impact on the investigation.

Her travels to Germany took her to the Institut Fur Biologische Forschung, or Institute for Biological Research, a laboratory that Philip Morris had set up in Cologne, which has been criticized by antitobacco activists and cancer doctors. The establishment of the lab overseas, where topics of study included the role of tobacco in cancerous tumors, had allowed the company to keep conducting research there, beyond the reach of the United States government, news media and plaintiffs’ lawyers.

Ms. Gillibrand learned so much about the laboratory’s inner workings during the criminal investigation that by 1997, records show, she provided Philip Morris lawyers with a list of questions about the German lab to help them prepare company witnesses being called to testify in civil cases in Minnesota and elsewhere across the country.

At the laboratory, she interviewed Dr. Max Reininghaus, the general manager who oversaw the experiments, and reviewed lab personnel records that had been sought by federal investigators.

In 1998, when the case reached a turning point as one tobacco company, the Liggett Group, considered cooperating with prosecutors, Ms. Gillibrand was one of a handful of lawyers for Philip Morris privy to the unsuccessful efforts to dissuade Liggett from breaking ranks with the other cigarette makers.

She was also among the small group of Philip Morris lawyers involved in the effort to contain the damage the defection could do to other companies in the tobacco industry, pushing to prevent Philip Morris from disclosing any documents that would violate the confidentiality of the other co-defendants.

“She clearly was more than a lowly associate lawyer on the case,” said Anne Landman, a tobacco document researcher who has testified against the industry and edits Tobaccowiki.org, a Web site that provides analysis of tobacco documents. “Philip Morris showed deep trust in her and brought her in on sensitive legal matters that were of great importance to the company.”

In the face of the vigorous counteroffensive from the industry, the Justice Department abandoned its criminal inquiry in 1999 and decided to bring a racketeering case in civil court, claiming that the cigarette companies conspired for half a century to mislead the public about the dangers of smoking.

Ms. Gillibrand did not work on the racketeering case, on which other law firms took the lead. But when Judge Gladys Kessler of Federal District Court handed down her landmark decision in that case in 2006, finding that the tobacco companies had conspired to defraud the public, she based the ruling in part on the business practices Ms. Gillibrand had delved into during the perjury case. The judge cited Philip Morris’s use of the German lab as a way for the company to suppress evidence and scolded the company for concealing information from consumers and government regulators.

Asked last week whether Ms. Gillibrand agreed with the judge’s decision, her spokesman replied: “Senator Gillibrand did not work on that case and is not familiar with its details.”

A Rising Star

Ms. Gillibrand was also deeply involved as Philip Morris and other cigarette makers confronted another challenge: mounting accusations that the industry was abusing the attorney-client privilege to prevent disclosure of damaging research and other sensitive documents.

Legal experts and a Congressional committee said that for decades, the companies had misused the attorney-client privilege to try to conceal scientific information that was damaging to the industry. The lawyers, for example, participated in overseeing scientific research projects that they could then keep confidential. But in the 1990s, government and plaintiffs’ lawyers began directly challenging this protection.

The state of Minnesota, as part of a lawsuit seeking to force tobacco firms to pick up the state’s cost of treating smoking-related illnesses, objected to the companies’ claim of attorney-client privilege, invoking what is known as the crime-fraud exception: essentially, an assertion that the privilege did not apply because the lawyers were being used to help the companies commit fraud. A Minnesota judge agreed, saying that Philip Morris had engaged in an “egregious attempt to hide information” and, in a major blow to the industry, eventually forced the release of some 30 million pages of documents from industry files.

Philip Morris and the other companies subsequently settled the Minnesota case for $6 billion in 1998.

But with the industry facing other lawsuits around the country, Philip Morris turned to a committee it established to handle issues surrounding disclosure of other documents. In some instances, the committee sought to determine if certain documents had been improperly shielded under attorney-client privilege rule. But the committee also worked to protect other industry documents from being released, a practice that drew harsh criticism from lawyers and others who took on the industry.

Clifford Douglas, who served as a lawyer for the Congressional task force that looked into the tobacco industry’s practices, said, “The crime fraud committee was charged with preventing plaintiffs or the government from seeing sensitive documents that Philip Morris wanted to keep secret.”

Some of the nation’s most prominent tobacco lawyers from several prestigious law firms had seats on the committee, known as the Philip Morris Crime Fraud Issues Committee. And so did Ms. Gillibrand, who was already seen as a rising star among her colleagues at Davis Polk.

Mr. Chang, who worked with her at the firm, said it was telling that Ms. Gillibrand would be assigned to the panel along with “the linchpins of the tobacco defense bar in the entire country.”

“That’s certainly an indicator of the kind of respect that she was accorded at Davis Polk that they would chose her — a relatively junior associate — to be on a panel with some of the most prominent senior tobacco lawyers in the country,” he said.

Leslie Wharton, a senior counsel at the Washington law firm of Arnold Porter L.L.P. and a member of the crime fraud committee, said that although Ms. Gillibrand had less experience and stature than other lawyers on the panel, she was assertive, deeply involved and very effective in advocating on behalf of Philip Morris.

“She did more than pull her own weight,” Ms. Wharton said. “We handled highly specialized issues on a whole variety of cases, and she was a full partner in everything we did. She worked as hard as anyone and was a very capable, smart lawyer.”

Much of the committee’s work remains sealed, but internal documents indicate that the committee had wide latitude and “should be consulted with respect to just about any privilege issue that might arise in any case.”

A Philip Morris spokesman declined to discuss the committee or when it was formed.

Helping With Strategy

At Davis Polk, lawyers not only represented Philip Morris in litigation, they advised the company on business strategy, including how to protect the image of the cigarette company and how to deal with concerns about the effects of its products. This approach reflects, in part, the longstanding closeness between the firm and tobacco makers. But it also raised concerns among critics that the lawyers had crossed a line, and were essentially becoming agents in the business operation.

There were instances, for example, when Ms. Gillibrand was called upon to help the company deal with mounting public unease about its product and practices, according to interviews and a review of industry documents. Ms. Gillibrand was also schooled in some of the chemistry of cigarettes.

In 1998, for example, Roger G. Whidden, Philip Morris’s vice president for worldwide regulatory affairs, wrote Ms. Gillibrand a letter along with a draft document containing proposed responses to possible questions from reporters about nitrosamines, a cancer-causing agent in cigarettes.

In the letter, Mr. Whidden tells Ms. Gillibrand that the draft was prepared “on the basis of conversations” with her and others at Philip Morris, and asks her to review it. The suggested answers state that Philip Morris is working to reduce the presence of the deadly agent in cigarette smoke.

But the document also makes an assertion that experts say is highly misleading. The document declares flatly that the amount of nitrosamines in cigarette smoke had been reduced through filtration. That assertion was not in keeping with what was known about limitations of certain cigarette filters at the time, the experts say: smokers frequently compensated for them by inhaling more deeply, plugging up filter ventilation holes with their fingers or lips or taking more puffs.

The tobacco companies had been aware of this flaw in the filters for decades, according to industry documents and interviews, and Ms Gillibrand had just weeks before been briefed on their shortcomings and had taken a tour of the filtration section of Philip Morris’s production plant, according to company documents.

The presentation was given by Bill Dwyer, a scientist in the company’s research and development division, who described, among other things, how plugging the ventilation holes of filters diminishes the effectiveness of the filters.

    As New Lawyer, Senator Defended Big Tobacco, NYT, 27.3.2009, http://www.nytimes.com/2009/03/27/nyregion/27gillibrand.html?hp

Contraception Pill Strictures

Are Eased by a Judge

March 24, 2009
The New York Times
By NATASHA SINGER

A federal judge ordered the Food and Drug Administration on Monday to make the Plan B morning-after birth control pill available without prescription to women as young as 17.

The judge ruled that the agency had improperly bowed to political pressure from the Bush administration in 2006 when it set 18 as the age limit.

The agency has 30 days to comply with the order, in which the judge also urged the agency to consider removing all restrictions on over-the-counter sales of Plan B. The drug consists of two pills that prevent conception if taken within 72 hours of sexual intercourse.

Some women’s health advocates hailed the decision.

“It is a complete vindication of the argument that reproductive rights advocates have been making for years, that in the Bush administration it was politics, not science, driving decisions around women’s health,” said Nancy Northup, president of the Center for Reproductive Rights, the attorneys for the plaintiff in the suit against the F.D.A.

But some conservative groups voiced concern that the ruling could promote sexual promiscuity. “Now some minor girls will be able to obtain this drug without any guidance from a doctor and without any parental supervision,” the Family Research Council said in a statement.

Plan B has been available by prescription in the United States since 1999.

But because the drug must be taken so soon after intercourse to be effective, in 2001 more than five dozen public health groups, with endorsements from World Health Organization and the American Medical Association, asked the F.D.A. to make Plan B available over the counter.

Not until 2006 did the F.D.A. rule, saying that the drug could be sold without a prescription only to women over 18. In order to enforce the age restriction, the agency also ordered that Plan B be stocked behind pharmacy counters, in contrast to other over-the-counter contraceptives like condoms.

On Monday, in a decision that criticized former F.D.A. officials, Judge Edward R. Korman of Federal District Court in New York threw out the F.D.A. ruling.

Judge Korman wrote that officials of the agency had repeatedly delayed action on the petition, moving only when members of Congress threatened to hold up confirmation hearings on acting F.D.A. commissioners. Several officials also violated the agency’s own policies, he wrote.

Citing depositions, Judge Korman wrote that agency officials had improperly communicated with White House officials about Plan B. And, he said, F.D.A. employees sought to influence decisions by appointing people with anti-abortion views to an independent panel of experts reviewing Plan B for the agency.

The agency also departed from its normal procedures, the judge wrote, by ignoring favorable conclusions about the drug by an advisory panel as well its own scientists and officials who found that the drug could be safely used by women at least as young as 17.

Such “political considerations, delays and implausible justifications” showed that the F.D.A. had acted without good faith or reasoned decision making, Judge Korman wrote.

Susan F. Wood, a former F.D.A. director of women’s health who resigned in 2005 to protest the handling of Plan B, said Monday that the judge’s decision to send the drug back for reconsideration signaled hope of the agency’s ability to act independently under a new administration.

There is a new chance to “restore the scientific integrity of the F.D.A.,” said Ms. Wood, now a professor of public health at George Washington University.

In response to a query from a reporter, an F.D.A. spokeswoman wrote Monday in an e-mail message that the agency was still reviewing the decision.

    Contraception Pill Strictures Are Eased by a Judge, NYT, 24.3.2009, http://www.nytimes.com/2009/03/24/health/24pill.html?hp

Editorial

The Rules on Stem Cells

March 16, 2009
The New York Times
 

No sooner had President Obama lifted the Bush-era restrictions on financing embryonic stem cell research than critics began urging that any federal support be limited to work with stem cells derived from surplus embryos at fertility clinics. That would be a mistake. The guidelines should define the eligible research as broadly as possible to allow the greatest potential for advances.

Some of the most important research requires stem cells genetically matched to patients with specific diseases, such as Parkinson’s or diabetes. These can rarely be identified in the huge stock of surplus embryos.

President Bush limited scientists to 21 stem cell lines derived from surplus embryos before mid-2001. Congress twice passed bills to allow potentially thousands more lines from surplus embryos to be used. Mr. Bush vetoed them. (Hundreds of stem cell lines have been created around the world, all or virtually all from surplus embryos.)

This single-minded focus on the surplus embryos — left over after patients’ fertility treatments were completed — was mostly because a strong moral argument could be made that these microscopic, days-old embryos were doomed to be discarded anyway. Why not gain potential medical benefits from studying their stem cells?

Now President Obama seems open to the possibility of moving beyond the surplus embryos. His announcement placed few boundaries on stem cell research beyond requiring it to be scientifically worthy, responsibly conducted and compliant with the law.

He gave the National Institutes of Health free rein to devise guidelines governing what kinds of research can be supported and what ethical strictures will be placed on it.

Let us hope that the N.I.H. broadens the range of stem cells that can be studied.

Scientists believe that one way to obtain the matched cells needed to study diseases is to use a cell from an adult afflicted with that disease to create a genetically matched embryo and extract its stem cells. This approach — known as somatic cell nuclear transfer — is difficult, and no one has yet done it.

Another approach — known as induced pluripotent stem cells — has shown that adult skin cells can be converted back to a state resembling embryonic stem cells without ever creating or destroying an embryo. Some experts think that approach may be the most promising, for moral and practical reasons.

Even so, work on genetically matched embryonic stem cells would still be important. They may be the best way to study the earliest stages of a disease, or prove superior for other purposes. They will almost certainly be needed as a standard to judge the value of the induced pluripotent cells.

When the N.I.H. sets the rules for federally financed research, the main criterion should be whether a proposal has high scientific merit.

    The Rules on Stem Cells, NYT, 16.3.2009, http://www.nytimes.com/2009/03/16/opinion/16mon1.html

Letters

Doctor-Patient-Computer Relationships

March 11, 2009
The New York Times

To the Editor:

Re “The Computer Will See You Now” (Op-Ed, March 6):

Dr. Anne Armstrong-Coben has provided a spot-on description of the fallibilities of the electronic medical record from the standpoint of the doctor-patient encounter. It can depersonalize situations that require personal interaction. To her account, let me add one thing I’ve noticed.

All too often when taking a history, residents and attendings in a hurry will simply use the cut-and-paste function to save time and bypass asking potentially important questions that have been asked before. Without ever undergoing independent verification, erroneous data from the original history gets perpetuated. Doctors rely on others for their own versions of events, a potential source of misinformation and error.

Cory Franklin
Wilmette, Ill., March 6, 2009

The writer is a former director of medical intensive care, Cook County Hospital, Chicago.

•

To the Editor:

Dr. Anne Armstrong-Coben presents her experience in adapting to electronic medical records as a cautionary tale, proscribing an open embrace of the computer in the doctor-patient relationship.

Is it too much to expect that physicians who continually educate themselves on the latest medical treatments also integrate the latest improvements in delivering that care? I have found that my last year with electronic medical records in my practice has been a step forward for the health of my patients.

Maintaining the doctor-patient relationship required adaptation to technology, not submission to it.

Jihad Shoshara
La Grange, Ill., March 6, 2009

The writer is a medical doctor.

•

To the Editor:

I must agree wholeheartedly with Dr. Anne Armstrong-Coben: the presence of a computer in the exam room is more of a detriment than an advantage.

The physician focuses on the computer and misses patient or parental body language (I’m a pediatrician, too). Awful mistakes may get clicked and pass unnoticed. Girls may be described as having male genitalia and vice versa.

What is most troublesome to me is that our residents — no matter how much we grayheads or graybeards model the approach to history-taking from parents — learn that the checklist on the computer screen is the thing to look at, and not the living person describing their child and her problems.

Howard Fischer
Detroit, March 6, 2009

The writer is a professor of pediatrics at Wayne State University School of Medicine.

•

To the Editor:

I could not agree more with Dr. Anne Armstrong-Coben. The computers we all use were invented as bookkeeping machines. At this they are superb.

They are not good at shoehorning the analog world into digital format. In fact, computers aren’t meant to help physicians; they are meant to gather data for others at the expense of physicians’ time, attention and job performance.

I am an anesthesiologist. In the operating room, computerization is useful for recording metrics like pulse and blood pressure. Even here, computers hijack my attention and interfere with my job.

We can’t do two tasks at once, and computers require just that.

Michael Cox
Santa Barbara, Calif., March 6, 2009

•

To the Editor:

A mentor of mine once told a story of a patient whose son admired a certain Russian poet. He made a notation of this in his office note.

Several years later, upon seeing this woman again, he inquired as to whether her son “still read Pushkin.” The patient nearly fell off her chair, so taken was she by her doctor’s recalling this seemingly trivial but meaningful fact.

I have used this anecdote repeatedly in my own career, jotting down reminders as to my own patients’ reading proclivities and other personal miscellany. Bringing up these tidbits at future visits is useful in creating trust between patient and doctor.

Unfortunately, I have yet to encounter an electronic medical record system that allows one to document the reading habits of the patient or his family members.

Ronald B. Cohen
Woodbury, N.Y., March 6, 2009

•

To the Editor:

Dr. Anne Armstrong-Coben makes a legitimate point about computerizing physicians’ notes. The model she describes is simply a glorified questionnaire, similar to the one on that clipboard we’re asked to fill out in the waiting room during our first visit. That model is neither efficient nor effective.

What could work would be to take notes as she is now doing, then scan them into the permanent electronic record. This would achieve the accessibility of electronic records, and the personalization she wishes to retain.

As for the illegible handwriting: That’s a product of laziness; almost anyone can teach himself to write legibly!

Warren Bailey
Qualicum Beach, British Columbia
March 6, 2009

The writer is a retired cardiac surgeon.

•

To the Editor:

This transference from human to computer, as if the records become the human, isn’t special to the medical profession. It exists in other professions and in any institution where personal data are electronically gathered.

It explains how you can feel as if you barely exist when in front of a keeper of these records, whether a doctor or a clerk at your local motor vehicle agency.

As they stare intently into their computer screens, they are looking at the real you that exists for them, the one in the computer.

Peter Carr
Berkeley, Calif., March 6, 2009

•

To the Editor:

Dr. Anne Armstrong-Coben’s story is a cautionary tale. It illustrates why most of the $17 billion in President Obama’s stimulus package for promoting electronic medical records will add to the cost of care, not reduce it.

Dr. Armstrong-Coben is applying the computer to a method of pediatric practice that has been in effect from time immemorial. The cost of computers has been added to the cost of her practice without, it seems, improving her efficiency.

What she ought to be doing is thinking up a new, better and less expensive way to provide health care to children that is practical only with computers and then get someone to develop a program to support it.

Not being a pediatrician, I would not presume to suggest what that way might be, but I’m sure that it is out there waiting to be discovered.

Richard Wittrup
Scituate, Mass., March 6, 2009

The writer is a retired hospital administrator.

    Doctor-Patient-Computer Relationships, NYT, 11.3.2009, http://www.nytimes.com/2009/03/11/opinion/l11medical.html

21% of Americans

scramble to pay medical, drug bills

10 March 2009
USA Today
By Liz Szabo and Julie Appleby

Denise Prosser, 39, has battled cancer since she was a toddler.

Yet Prosser can't afford her next cancer treatment — a radioactive therapy that she's supposed to receive once a year — because she and her husband lost their jobs in December. Without insurance, she has postponed the radiation indefinitely and is taking only half of her asthma medications — sacrifices that often leave her gasping for air and could allow her cancer to come surging back.

"I can't walk more than 100 feet without sounding like I just ran a marathon," says Prosser, of Galloway, N.J.

Prosser is among millions of Americans who struggled last year to pay for health care or medications, the largest poll ever conducted by Gallup shows.

As the economy fell, the percentage who reported having trouble paying for needed health care or medicines during the previous 12 months rose from 18% in January 2008 to 21% in December, according to the poll of 355,334 Americans. Each percentage point change in the full survey represents about 2.2 million people, says Jim Harter, Gallup's chief scientist for well-being and workplace management.

Gallup, along with disease management company Healthways, surveyed a random sample of about 1,000 people nearly every day during 2008 about their physical, emotional and economic well-being.

The poll, the Gallup-Healthways Well-Being Index, shows that struggles to pay crossed all socioeconomic lines but hit some Americans harder than others: More than half of the uninsured had trouble paying for health care or medications during the year. So did more than 30% of blacks and Hispanics, compared with 17% of whites and 13% of Asians. Overall, women had more trouble than men. Those who were divorced, widowed or in domestic partner arrangements fared less well than those who were married.

Among other key findings:

• As the year progressed, fewer Americans reported getting health coverage through their jobs, dropping from 59% in the first quarter to 58% by the last.

• The number of African Americans reporting trouble paying for health care or medications rose six percentage points from the first quarter to the last, to 34%. People ages 25-34 also saw a big increase, up five points to 28%.

• Among the states, Hawaii had the smallest percentage of residents who had trouble paying for health care in the previous 12 months at 12%, and Mississippi the most at 29%.

"The biggest problem that the country has is actually the cost of health care," says Jim Clifton, Gallup's CEO. "It's a lot bigger problem than war and a bigger problem than the current meltdown because there are no fixes to it on the horizon right now. … You can't just throw money at it. That's still not a fix."

The increasing trouble people have paying for medical care comes as Congress begins its most serious health care overhaul debate in 15 years — and as the economy continues to shed jobs.

Because most people still get health insurance through their jobs — rather than buying it themselves or being covered by a government program such as Medicare — the loss of a job can mean the loss of insurance.

Nearly 4.4 million people have lost jobs since the recession began in December 2007, the U.S. Department of Labor reports. Nearly one in 10 children and one in five adults under age 65 are uninsured, says a February report on the uninsured from the Institute of Medicine, part of the National Academy of Sciences, which advises the government on health care.

People without insurance are at much higher risk for a host of medical problems, the institute's report shows. They're less likely to get preventive care, more likely to be diagnosed with later-stage cancers and more likely to die if they suffer a heart attack, stroke, lung problem, hip fracture, seizure or trauma.

"The evidence clearly shows that lack of health insurance is hazardous to one's health," says report co-author Lawrence Lewin. "And the situation is getting worse."

Lower-income residents are more likely to have trouble paying medical bills and to lack insurance. Income also plays a role in how people feel about their own physical well-being.

The Gallup-Healthways poll found that 40% of those making $500 to $1,000 a month said they were dissatisfied with their health. By comparison, only 10% of wealthy people — those making at least $10,000 a month — are dissatisfied with their health.

Few safety nets

People often resort to desperate solutions to pay for health care for themselves and their families, says Christy Schmidt, senior policy director at the American Cancer Society's Cancer Action Network.

Some are tapping into their 401(k) plans and other retirement savings, she says. But even these funds may fall short, since many investments have lost half their value in the past year.

When money gets really tight, Schmidt says, many uninsured people cut corners on their health, such as by cutting pills in half or skipping doctor's appointments.

While Gallup's poll asked if the specific person being interviewed had cut back on "needed" health care, a February poll by Kaiser Family Foundation took a broader look at health care spending. In that poll, more than half of Americans said at least one person in their family had cut back on medical care within the previous 12 months because of cost.

Many people can't pay for coverage on their own, Schmidt says.

Among them are Denise Prosser, who worked part time in a day care before being laid off, and her husband, Warren, who was a television news director in Linwood, N.J.

The 600 stitches on her back testify to her long struggle with cancer. She was first diagnosed at 18 months old. A new tumor, in her thyroid, developed when she was 27. Her lung capacity has declined by 50% since then as her health has deteriorated, leaving her unable to work full time.

The Prossers say they can't afford coverage through COBRA, a program that allows workers to keep their health insurance for 18 months after they leave their jobs, just as long as they pay 100% of the health premiums themselves.

A COBRA plan would cost the Prossers $900 a month, Denise says. With help from the recently passed economic stimulus package, which provides a federal subsidy worth 65% of COBRA premiums, the Prossers still would have to pay $300 a month — an especially high price tag for people who no longer have regular salaries.

After she lost her job, Prosser applied for official status as disabled through the Social Security Administration but was turned down: "They said I wasn't disabled enough."

Even patients who qualify as disabled may struggle with medical bills, Schmidt says. Most people have to wait two years after being declared disabled before they qualify for Medicare coverage. If patients opt for 18 months of COBRA, that still leaves a six-month gap.

That puts Prosser — whose doctor recently found a lump on her thyroid — in a sort of no man's land.

Prosser fears the lump could be a relapse of the thyroid cancer she developed in 1997. Although her thyroid specialist gave her some free medication samples, the doctor would not treat Prosser without insurance.

Prosser hopes to see a doctor through a charity clinic in Atlantic City but worries her husband's income from his unemployment check — $622 a week before taxes — may disqualify them.

A domino effect

Even charity care and emergency rooms can't guarantee that uninsured people — especially those such as Prosser, who have a long history of complex problems — get the treatment they need, says John Ayanian, a Harvard Medical School professor and co-author of the Institute of Medicine report. Free clinics often struggle just to find generalists, he says, let alone specialists.

The problem extends beyond individual struggles.

Eroding insurance coverage can undermine the health of entire communities, Ayanian says. Hospitals and doctors may have trouble paying their own bills in communities with large numbers of uninsured. That can drive away specialists and make it harder for even well-insured people to find care, the report says.

Often, people without insurance must struggle on their own.

Calls to the cancer society's insurance hotline have increased by 6% since last year, Schmidt says. Although the society sometimes can help patients find coverage, three out of five callers find those options — such as individual health policies or state-sponsored high-risk pools — too expensive, Schmidt says.

Nor is there any guarantee those options will be available. Individual policies sometimes won't cover pre-existing medical conditions, such as cancer, depression or pregnancy, or will not pay for care needed for those conditions during an initial period of six months or more.

Dropping insurance

Jim Hann, 51, who's losing his job as a chemical operator at the Americas Styrenics plant in Marietta, Ohio, next month, won't be able to afford COBRA, even with the federal subsidy. The plant is laying off 65 of 100 employees. That didn't deter him, however, from donating a kidney to his wife, Hannah.

In the past decade, Hannah has weathered more surgeries than they can count: seven or eight operations to cut away dying sections of bowel, a small intestine transplant and, in February, the kidney transplant at Washington's Georgetown University Hospital.

"He tells me he'd give me both of his if that's what it took," says Hannah, 49, a few days after the February transplant.

Their surgeon moved up her transplant surgery by a month, before Jim's coverage lapsed. Although Hannah's disability makes her eligible for Medicare, she has used Jim's generous company-funded insurance until now. Medicare will cover her health care after Jim loses his coverage in November.

Jim plans to get by without any insurance. That's a gamble, given that kidney donors have an increased risk of high blood pressure and kidney problems.

After taking care of Hannah for so many years, Jim says he's well-prepared for his next career.

He has decided to enroll in a nursing program that will make him a registered nurse within two years. Until then, he says, the couple will "tough it out" by living off their savings, Hannah's disability check and the proceeds they make selling their home to move into a smaller, cheaper house. If needed, Jim says he's prepared to return to driving a truck or waiting tables while going to school.

But he doubts he'll ever find another job like the one he lost. Factories are laying off at least 1,000 workers in the region around Marietta and Ravenswood, W.Va., about 50 miles away, where Century Aluminum is shutting down a plant and letting go about 600 employees.

The Gallup-Healthways survey found nearly 25% of people in the congressional district that includes Marietta didn't have enough money to pay for health care in the past year.

"There aren't even any bad jobs," Jim says. "It's the same all over."

Contributing: Susan Page

    21% of Americans scramble to pay medical, drug bills, UT, 10.3.2009, http://www.usatoday.com/news/health/2009-03-10-gallup-medical-bills_N.htm

Editorial

Science and Stem Cells

March 10, 2009
The New York Times

We welcome President Obama’s decision to lift the Bush administration’s restrictions on federal financing for embryonic stem cell research. His move ends a long, bleak period in which the moral objections of religious conservatives were allowed to constrain the progress of a medically important science.

Even with this enlightened stance, some promising stem cell research will still be denied federal dollars. For that to change, Congress must lift a separate ban that it has imposed every year since the mid-1990s.

Mr. Obama also pledged on Monday to base his administration’s policy decisions on sound science, undistorted by politics or ideology. He ordered his science office to develop a plan for all government agencies to achieve that goal.

Such a pledge should be unnecessary. Unfortunately, for eight years, former President George W. Bush did just the opposite. He chose scientific advisory committees based on ideology rather than expertise. His political appointees aggressively ignored, distorted or suppressed scientific findings to promote a political agenda or curry favor with big business.

This cynical approach seriously hampered government efforts to address global warming and encourage sound family planning practices, among other issues.

President Obama was appropriately cautious, warning that the full promise of stem cell research remains unknown and should not be overstated. Some of the benefits, he said, might not appear in our lifetime or even our children’s lifetime. But scientists hope that stem cell therapies may eventually lead to treatments or cures for a wide range of degenerative diseases, such as Parkinson’s and diabetes, and Mr. Obama rightly promised to pursue the research with urgency.

In one of his first acts as president, Mr. Bush restricted federal financing for embryonic stem cell research to what turned out to be 20 or so stem cell lines that had been created prior to his announcement. Those lines are too limited in number, variety and quality to allow the full range of needed research.

With the end of the Bush restrictions, scientists receiving federal money will be able to work with hundreds of stem cell lines that have since been created — and many more that will be created in the future. The full range of additional research allowed won’t become apparent until new guidelines governing what research can qualify for federal support are issued by the National Institutes of Health.

Other important embryonic research is still being hobbled by the so-called Dickey-Wicker amendment. The amendment, which is regularly attached to appropriations bills for the Department of Health and Human Services, prohibits the use of federal funds to support scientific work that involves the destruction of human embryos (as happens when stem cells are extracted) or the creation of embryos for research purposes.

Until that changes, scientists who want to create embryos — and extract stem cells — matched to patients with specific diseases will have to rely on private or state support. Such research is one promising way to learn how the diseases develop and devise the best treatments. Congress should follow Mr. Obama’s lead and lift this prohibition so such important work can benefit from an infusion of federal dollars.

    Science and Stem Cells, 10.3.2009, http://www.nytimes.com/2009/03/10/opinion/10tue1.html

Drug Investors Lose Patience

March 10, 2009
The New York Times
By ANDREW POLLACK

As merger mania plays out among the pharmaceutical giants, a different sort of financial frenzy has seized some small, struggling drug makers. Investors are demanding that stragglers close up shop and hand over any remaining cash.

That is what happened to one company, Avigen, after its most promising drug failed in a clinical trial last October. Avigen said it would do what countless other biotechnology companies had done in similar circumstances: move on to the next product in its pipeline.

Not so fast, said its biggest shareholder, the Biotechnology Value Fund. The fund demanded that Avigen, after 16 years of trial and error, immediately liquidate itself and return its remaining cash to shareholders.

So much for the traditional model of patience in biotechnology investing, in which companies may burn through more than a decade and hundreds of millions of venture capital or shareholder dollars before reaching profitability — if they ever get there. Now, with cash scarce, credit tight and big drug companies like Merck intent on branching into biotechnology themselves, struggling start-ups may no longer get second and third chances to succeed.

In at least eight cases in the last year, anxious investors have tried to block an unsuccessful biotech company’s quest for the next blockbuster, and have fought with management for control of the corporate carcass. The investors argue that the remaining cash belongs to them and that they — not a losing company’s executives — should decide how to invest it.

Some companies, including Avigen, are fighting back. “I hear that argument” about shareholder rights, said Kenneth G. Chahine, Avigen’s chief. “But it’s really ‘I want to raid the cash.’ We’re back to 1987 and ‘Barbarians at the Gate.’ ”

Such battles have become much more common in recent months, as the stock market crash has pounded the value of many biotech companies to less than the cash on hand. When that happens, investors can realize an immediate return if the company dissolves itself — even if some of the cash will be consumed in closing the company.

In some cases, investors are succeeding. Under pressure from the hedge fund RA Capital Management, for example, Northstar Neuroscience, a medical device company in Seattle whose stroke treatment failed, is proposing to liquidate, with shareholders receiving an estimated $1.90 to $2.10 a share in cash. The company’s stock, which had been as low as 90 cents in November, closed at $1.90 on Monday.

Another company, Trimeris, whose only product, the AIDS drug Fuzeon, has lost sales to newer competitors, halted research and development last year and repaid $55 million — or $2.50 a share — to stockholders. The company continues in business, but with few employees.

And two companies, VaxGen and NitroMed, have canceled planned reverse mergers because of shareholder opposition. In a reverse merger, a publicly traded company essentially cedes its cash and stock listing to a private company with presumably better prospects.

For every Gilead Sciences, which spent $450 million over 15 years and abandoned its original technology before becoming profitable, there have been countless “zombies” — companies that lurch from product to product, surviving years or even decades without ever achieving success.

One company so tarred, by one of its biggest investors, is Penwest Pharmaceuticals.

“The company’s history is an unfortunate progression of failed development programs,” Perceptive Advisors, an investor in the company, wrote in November to Penwest’s board. Perceptive demanded that Penwest cease all research and development and become a virtual company that would just collect royalties on its one successful drug. Penwest defended its track record and said it was sticking to its course.

Some investors say that with capital markets now so tight, the walking dead should be buried to free up financing for more viable companies. “It’s in a time like this that the good companies are being dragged down by the bad ones,” said Oleg Nodelman, a portfolio manager at the Biotechnology Value Fund.

In some cases, however, the investors asking for their money back are not long-suffering shareholders. They are speculators who bought in only after the stock price collapsed, hoping to make a quick killing.

Tang Capital Partners, for instance, began accumulating its 14.9 percent stake in Vanda Pharmaceuticals only after the Food and Drug Administration rejected Vanda’s schizophrenia drug in July. Tang is now pressing for the company to cease all operations and return cash to shareholders. Vanda’s stock is trading at 80 cents, well below the $1.74 a share in cash it had as of Dec. 31.

Vanda says that it is still hopeful that it can get its drug approved and that liquidation is not in the interest of all shareholders.

The Biotechnology Value Fund, often called BVF, was a longtime shareholder in Avigen. But it sold 640,000 shares, nearly all its holdings, for about $3.95 to $4.60 a share. The sale was near the stock’s highs for the year — in the two months before Avigen was scheduled to announce, in October, the clinical trial results of its drug to treat a symptom of multiple sclerosis.

After the drug failed, BVF swooped in and bought more than eight million shares, nearly a 30 percent stake, at about 58 cents a share. That was well below Avigen’s cash total of about $1.90 a share at the time.

BVF has made a $1-a-share tender offer for Avigen and is trying to replace the directors. If it gains control, it could liquidate Avigen or sell it to MediciNova, which has said it wants to buy it. Mr. Chahine, the chief of Avigen, which is based in Alameda, Calif., said its assets might be parlayed into a deal that would be worth more than BVF or MediciNova would pay and more than the liquidation value. “All we’re saying is, give us an opportunity to canvass the field, see what’s out there and bring something to the shareholders,” he said.

But Mr. Nodelman said such a process might eat up the company’s remaining cash. “Someone’s got to police the space,” he said. “We’re making sure that the last $50 million in the company don’t go to the bankers and the consultants and the golden parachutes.”

BVF, which specializes in smaller biotech companies, has become the most outspoken investor pressing for its money back. The fund, based in San Francisco, gets about half of its capital from the Ziff family, which made its fortune in magazine publishing.

Mr. Nodelman makes no apologies for BVF’s having bought Avigen stock again after the collapse. The fund is also pressing for a cash-out to shareholders from CombinatoRx. BVF has been a continuous shareholder in the company, although it added to its stake after some CombinatoRx clinical trials failed.

CombinatoRx, whose strategy is to combine two old drugs to make one new one, has lost $236 million since its inception in 2000. The company has about $1.45 a share in cash, but its stock is trading for only 66 cents.

Alexis Borisy, the chief executive, said the company, based in Cambridge, Mass., was not ready for the grave. “We obviously think there’s a lot of upside value in the CombinatoRx technology,” he said.

BVF and CombinatoRx are now in confidential discussions about the company’s future.

BVF is also one of four investors, which collectively own about two-thirds of the shares, demanding money back from Neurobiological Technologies of Emeryville, Calif.

The company’s stroke drug is derived from the venom of the Malayan pit viper. Three of the investors, including BVF, were shareholders when that drug failed in a clinical trial in December. The fourth bought in after the failure. The stock now trades at 58 cents, but its liquidation value would be as high as $1 a share.

Matthew Loar, the chief financial officer, said the company was sympathetic to the requests but had not yet decided what to do. In any case, he said, it could not act as fast as the investors want.

“You can’t just turn off the lights in a company in a day,” he said. Among other things, the company must figure out what to do with 1,000 poisonous snakes, he said. “We’re going to get rid of them in the most expeditious, reasonable way possible.”

    Drug Investors Lose Patience, NYT, 10.3.2009, http://www.nytimes.com/2009/03/10/business/10biocash.html

Letters

An Ethics Debate at Harvard Med

March 9, 2009
The New York Times

To the Editor:

Re “Patching a Wound: Working to End Conflicts at Harvard Medical” (Business Day, March 3):

Bravo to the Harvard medical students who are questioning medicine’s too-close links to the pharmaceutical industry. It has been well demonstrated that the outcome of research is often altered by the source of financing, even if the researchers’ motives are pure.

The idealism of these young medical trainees should be heeded and acted upon, especially as many of them may be the medical leaders of the future. A more regulated and transparent approach would help restore integrity and trust to modern medicine.

Steve Heilig
San Francisco, March 4, 2009

The writer is co-editor of The Cambridge Quarterly of Health Care Ethics.

•

To the Editor:

As a physician-scientist completing his training at a hospital affiliated with Harvard Medical School, I can verify that the complex relationships between medical faculty and the pharmaceutical industry can be fraught with conflicts of interest. But I take issue with the implicit assumption that faculty members who accept drug money are driven exclusively by greed; this issue is much more complicated than it may seem at first.

Harvard Medical School’s “drug money” problem relates, in part, to a little-known fact: Harvard rarely pays the salaries of its medical faculty directly. Despite substantial revenue from tuition, most faculty members teach medical students on a volunteer basis.

Similarly, the salaries of research faculty are not paid by Harvard, but rather by grants from the National Institutes of Health, private foundations and in some instances, grants from pharmaceutical companies. If these financing sources dry up, professors are often forced to find a new job.

Thus, in many cases, money from the pharmaceutical industry doesn’t increase the take-home pay of Harvard professors; it simply allows them to maintain their employment.

Daniel Becker
Brookline, Mass., March 4, 2009

The writer is a fellow in the Renal Division of Brigham and Women’s Hospital and a clinical fellow in medicine at Harvard Medical School.

•

To the Editor:

Your article implies that the “more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories,” are in complete agreement that industry and private affiliation are detrimental to academic medical research. Rather, the large number of students referred to signed a petition that advocated disclosure of industry ties, not further severance of industry relations.

In fact, both “rival factions,” as the article described them, agree that disclosure is important, but so are the relationships that foster quality research, new medicines and appropriate compensation for expertise.

The implication that some Harvard physicians and researchers abuse their academic posts for purely financial gains is unfounded. Many work tirelessly to advance science and spend years with little compensation developing marketable expertise in the clinic and the laboratory.

For example, in a course-based clinic centered on multiple myeloma treatment at the Dana Farber Cancer Institute, we have seen firsthand how dramatic improvements have been achieved through productive partnerships between academia and industry.

Many of these researchers and physicians have given up potentially lucrative careers in private practice or applied science to work in academia because of their passion to educate future clinicians. Most work tirelessly to improve patient care, advance their fields and collaborate on new treatment possibilities.

As future physicians, we feel that disclosure of financial conflicts of interest is essential to protecting our patients and that accurate information is axiomatic to any medical curriculum. Our faculty, administration and students operate within an institution that we believe provides superb patient care through innovation, research and integrity.

Charles William Carspecken
Taylor Lloyd, Melina Marmarelis
Brian Thomas Kalish
Ashley R. Kochanek
Tomasz Stryjewski
Boston, March 4, 2009

The writers are members of the class of 2012 at Harvard Medical School.

•

To the Editor:

As a 1959 graduate of Harvard Medical School, looking forward three months to the 50th reunion of my class, I am embarrassed to learn that my alma mater has received an F grade from the American Medical Student Association for its poor monitoring and controlling of drug industry money.

It is shocking that both the former dean and at least one current professor at Harvard Medical School have served concurrently as highly paid board members of pharmaceutical and medical products companies, and that, until recently, professors have been allowed to serve, without disclosure in many cases, as consultants to the manufacturers of the very products about which they teach. Their students, many of whom will become the next generation of leaders in American medicine, are being critically deprived of objective teaching. I am afraid that their future patients will suffer.

The only good news in the article is that a start has been made at reform. I hope that my reunion class will nudge this commendable effort along.

Cavin P. Leeman
New York, March 3, 2009

The writer is an emeritus clinical professor of psychiatry at SUNY Downstate Medical Center.

    An Ethics Debate at Harvard Med, NYT, 9.3.2009, http://www.nytimes.com/2009/03/09/opinion/l09harvard.html

Patient Money

Hanging On to Health Coverage,

if the Job Goes Away

March 7, 2009
The New York Times
By WALECIA KONRAD
 

If you’re fortunate to still have your job, but aren’t sure how much longer that will be the case, lost income may not be your only worry. Your medical insurance is at risk, too.

“When you’re still on the job, even if it’s just for a little while longer, you’re in a slightly better position to make the most of the benefits you have now and to figure out your options,” said the Oklahoma insurance commissioner, Kim Holland, a longtime promoter of affordable health insurance.

She and other experts offer the following advice about girding for the worst case.

Use it before you lose it. “My clients wouldn’t want to hear me say this,” said Tom Billet, a senior executive with the corporate benefits consulting firm Watson Wyatt. “But if you feel a layoff is pending, now is the time for you and your family to get physicals, dental check-ups, eye exams and prescriptions filled.”

That’s what Denise Young Farrell is doing. Ms. Farrell, the mother of two children in Park Slope, Brooklyn, lost her job early this year when her department at the Lifetime Networks cable channel moved to California. Her husband lost his job at Bear Stearns last year. Ms. Farrell’s severance package included two months of paid health care.

Check your benefits handbook to see how long your health care coverage will last if you do lose your job. Often, employers will continue coverage until the last day of the month in which the employee worked. So if your last day at work was March 5, for example, you may have coverage until March 31, giving you a few extra days for those doctor visits.

Sign onto your spouse’s plan. If your spouse has employer-sponsored family health insurance benefits, he or she can add you and your dependents anytime during the year. But do be aware of the deadlines. Most companies require any changes to be filed within 30 or 60 days of the “qualifying event.” Depending on your spouse’s company, that could mean the day you were laid off or your last day of coverage.

In addition, some companies require written proof from your former employer that you were laid off. To avoid snags, try to arrange this before your last day of work. And be sure to check when the new coverage takes effect. If your spouse’s plan has a three-month waiting period, for example, you’ll need to find temporary coverage elsewhere.

Get to know Cobra. If you have health benefits in your current job, odds are you’ll be eligible to continue purchasing that coverage temporarily under the 1986 law known by its acronym, Cobra.

Cobra requires employers with 20 or more workers to make health insurance available to a former employee for up to 18 months after leaving the job — regardless of whether you quit or were laid off. But because the former worker must pay the full cost of that insurance, the premiums can easily exceed $1,000 a month for family coverage.

The new federal stimulus plan that President Obama recently signed into law does provide some temporary relief for laid-off workers. But even if you qualify for the subsidy, you’ll still pay 35 percent of the total health premium, compared to the 10 or 15 percent you paid as an employee. So you might be paying $300 to $400 or more a month. And that is for only the first 9 months of the 18-month Cobra coverage. For the second nine months you’ll be paying full fare.

For fuller details on the new Cobra provisions, see this Congressional Web page.If you do choose Cobra, pace yourself. Time it right, and you can essentially get two months of free Cobra coverage.

After your last day of coverage under your employer’s plan, you have 63 days to sign up to extend that coverage under Cobra. If you think you’re on the verge of getting a new job, or if you’re trying to find a more affordable insurance option, you can put off paying two months of Cobra premiums until you approach the deadline. If the new job or alternate insurance works out, you will have avoided those hundreds of dollars in Cobra premiums. But if you do fall ill or get in an accident in the interim, you will be covered — as long as you pay those back premiums.

Do be vigilant, though, about that 63-day deadline. Miss it, and you lose your Cobra eligibility.

Try to negotiate health care as part of your severance. If you are eligible for any type of severance, consider asking for an extension of health insurance in exchange for a smaller cash payout. That will give you more time to research your health insurance options and help you avoid a gap in coverage.

There is one caveat, said Kathryn Bakich, national health care compliance director for the Segal Company, a benefits consulting firm: Avoid having your company pay part or all of your Cobra premiums as part of a severance agreement. Employers are still waiting for guidance on this point from the Department of Labor and other government agencies, but if your former employer pays your Cobra premiums directly, you may be ineligible for the new Cobra subsidy, according to Ms. Bakich and other benefits experts. You’d be better off trying get a lump sum payment that you could use to pay Cobra premiums, if extending your current coverage isn’t an option.

When Cobra is not an option ... If you work for a small company (fewer than 20 employees) that doesn’t offer Cobra, 40 states offer what’s called mini-Cobra continuation coverage that allows you to stay in your group plan. Some states may offer the new Cobra subsidy in these plans. (Check with your state’s insurance department.) If you do not have access to Cobra or a state continuation plan, or if those benefits are close to running out, it’s important to find insurance of some kind, whether it is group or individual.

Federal law mandates that at least one nongroup insurer in your state must provide coverage to everyone, regardless of health issues. In many cases this is your state’s high-risk insurance pool, but there are no limits on how much insurers can charge for this coverage, so premiums can be extremely expensive. For more information on what your state offers, go to the National Association of Insurance Commissioners’ Web site, naic.org, to link to your state’s insurance department.

If you have a flexible spending account — use it. Here’s a little known bonus in the employee’s favor:

Let’s say you signed up to contribute $1,000 this year through payroll deductions to your health care flexible spending account. So far you’ve only put in about $200. No matter. “Companies must still reimburse you for the full amount you’ve elected even if you haven’t contributed the total to the account yet,” Mr. Billet said.

In this example, if you file claims for $1,000 of eligible health care expenses before your last day on the job, you will get the full reimbursement — not just the $200 you’ve paid in.

    Hanging On to Health Coverage, if the Job Goes Away, NYT, 7.3.2009, http://www.nytimes.com/2009/03/07/health/policy/07patient.html?hp

Graham Roumieu

The Computer Will See You Now

NYT

6.3.2009

http://www.nytimes.com/2009/03/06/opinion/06coben.html?ref=opinion

Op-Ed Contributor

The Computer Will See You Now

March 6, 2009
The New York Times
By ANNE ARMSTRONG-COBEN

FOR 20 years, I practiced pediatric medicine with a “paper chart.” I would sit with my young patients and their families, chart in my lap, making eye contact and listening to their stories. I could take patients’ histories in the order they wanted to tell them or as I wanted to ask. I could draw pictures of birthmarks, rashes or injuries. I loved how patients could participate in their own charts — illustrating their cognitive development as they went from showing me how they could draw a line at age 2 and a circle at 3 to proudly writing their names at 5.

Now that I’ve been using a computer to keep patient records — a practice that I once looked forward to — my participation with patients too often consists of keeping them away from the keyboard while I’m working, for fear they’ll push a button that implodes all that I have just documented.

We have all heard about the wonderful ways in which electronic medical records are supposed to transform our broken health care system — by eradicating illegible handwriting and enabling doctors to share patients’ records with one another more easily. The recently passed federal stimulus package provides doctors and hospitals with $17 billion worth of incentive payments to switch to electronic records. The benefits may be real, but we should not sacrifice too much for them.

The problem is not just with pediatrics. Doctors in every specialty struggle daily to figure out a way to keep the computer from interfering with what should be going on in the exam room — making that crucial connection between doctor and patient. I find myself apologizing often, as I stare at a series of questions and boxes to be clicked on the screen and try to adapt them to the patient sitting before me. I am forced to bring up questions in the order they appear, to ask the parents of a laughing 2-year-old if she is “in pain,” and to restrain my potty mouth when the computer malfunctions or the screen locks up. I advise teenagers to limit computer time as I sit before one myself for hours each day until my own eyes twitch and my neck starts to spasm.

In short, the computer depersonalizes medicine. It ignores nuances that we do not measure but clearly influence care. In the past, I could pick up a chart and flip through it easily. Looking at a note, I could picture the visit and recall the story. Now a chart is a generic outline, screens filled with clicked boxes. Room is provided for text, but in the computer’s font, important points often get lost. I have half-joked with residents that they could type “child has no head” in the middle of a computer record — and it might be missed.

A box clicked unintentionally is as detrimental as an order written illegibly — maybe worse because it looks official. It takes more effort and thought to write a prescription than to pull up a menu of medications and click a box. I have seen how choosing the wrong box can lead to the wrong drug being prescribed.

So before we embrace the inevitable, there should be more discussion and study of electronic records, or at a minimum acknowledgment of the downside. A hybrid may be the answer — perhaps electronic records should be kept only on tablet computers, allowing the provider to write or draw, and to face the patient.

The personal relationships we build in primary care must remain a priority, because they are integral to improved health outcomes. Let us not forget this as we put keyboards and screens within the intimate walls of our medical homes.
 

Anne Armstrong-Coben is an assistant clinical professor of pediatrics at Columbia.

    The Computer Will See You Now, NYT, 6.3.2009, http://www.nytimes.com/2009/03/06/opinion/06coben.html?ref=opinion

Obama Tries to Start

Conversation on Health Care

March 5, 2009
By THE ASSOCIATED PRESS
The New York Times
Filed at 3:04 a.m. ET

WASHINGTON (AP) -- President Barack Obama has invited to the White House more than 120 people who hold a wide range of views on how to fix the world's costliest health care system, one that still leaves millions uninsured.

A broad group of doctors, patients, business owners and insurers were to gather for a forum Thursday in hopes of building support for big changes in health care. Republicans are invited, and they're expected to speak up.

''The president wants to engage with Congress in a transparent and bipartisan fashion,'' said Melody Barnes, who heads White House domestic policy.

Among the invitees are some who helped kill the Clinton administration's health care overhaul in the 1990s. Everyone is supposed to be on his best behavior, but will that last?

''This is a different day, '' said Chip Kahn, a hospital lobbyist who opposed President Bill Clinton's plan and was to attend Thursday's gathering. ''I think among most of the stakeholders, everyone wants to see this work. There is a tremendous feeling that it's time.''

Now president of the Federation of American Hospitals, Kahn worked for the insurance industry in the Clinton years.

The difference this time, Obama argues, is that health care costs have become unsustainable, particularly in a sinking economy. The U.S. spends $2.4 trillion a year on health care, yet an estimated 48 million Americans lack coverage. Obama's goal is health coverage for everyone.

Barnes said Obama is determined to pass health care legislation this year, and while he wants it to be bipartisan, he will not be deterred by obstruction from interest groups or ideological partisans.

''The president will make clear this has to be a bipartisan effort,'' Barnes said. ''As for people who are there to set up hurdles, from his perspective that isn't tolerable. It's crucial to families, businesses and our nation's budget that we address the issue of exploding costs.''

Senate Republican leader Mitch McConnell of Kentucky released a letter to Obama, saying his party is ready to work with the administration on health care, but warning that reforms should not lead to a government-run system, and must balance coverage expansions with curbs on costs.

In support of Obama's efforts, liberal activists have mobilized to keep the pressure on Congress to pass legislation this year.

''It would be a mistake to dismiss this as a gabfest,'' Drew Altman, president of the Kaiser Family Foundation, said about Obama's meeting. ''It's an effort to keep the momentum going. The details are not going to be worked in two or three hours at a White House summit.''

There were concerns Wednesday about some of those details.

Senate Finance Committee Chairman Max Baucus, D-Mont., who will play a leading role in writing health care legislation, raised questions about the proposed $634 billion ''down payment'' for expanded coverage that Obama included in the 2010 budget he released last week.

------

On the Net:

White House: http://www.whitehouse.gov/agenda/health--care/

    Obama Tries to Start Conversation on Health Care, NYT, 5.3.2009, http://www.nytimes.com/aponline/2009/03/05/washington/AP-Health-Care-Overhaul.html

Drug Approval

Is Not a Shield From Lawsuits,

Justices Rule

March 5, 2009
The New York Times
By DAVID STOUT

WASHINGTON — In one of the most important business cases in years, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the products and its labeling.

The 6-to-3 ruling went in favor of a Vermont woman, a musician, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the Wyeth pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases.

Ms. Levine had settled a parallel claim against the clinic where she was treated.

The key issue before the justices was whether the Food and Drug Administration’s approval of drug labels should control lawsuits in state courts contending, as Ms. Levine’s did, that the labels did not contain adequate warnings. Wyeth’s lawyers had argued that the company provided “ample, lavish warnings,” as one attorney put it, and that Wyeth should not been held liable, because the Food and Drug Administration had approved the label on the drug in question, Phenergan.

But the high court held, in an opinion by Justice John Paul Stevens, that Wyeth’s reading of the pertinent federal regulation was “cramped” and based on a “fundamental misunderstanding.”

“It is a central premise of the Food, Drug and Cosmetic Act and the F.D.A.’s regulations that the manufacturer bears responsibility for the content of its label at all times,” the majority concluded in Wyeth v. Levine, No. 06-1249.

The majority upheld the Vermont Supreme Court, which in 2006 rejected Wyeth’s argument that it had been put in an untenable position: having to comply with federal law, given its requirement that the F.D.A. approve drug labels, and yet being punished by the state jury’s verdict for not using a different, more inclusive label.

Federal law “provides a floor, not a ceiling, for state regulation,” the Vermont Supreme Court declared in the ruling that the United States Supreme Court affirmed on Wednesday.

Ms. Levine’s suffering began in the spring of 2000 when, suffering from a migraine, she visited a local clinic for a treatment she had received many times: Demerol for pain and Phenergan for nausea.

If Phenergan is exposed to arterial blood, it causes swift and irreversible gangrene. Therefore, it is typically administered by intramuscular injection. Ms. Levine’s lawyers said an intravenous drip is also quite safe.

But a physician used a third method, injecting the drug into what she thought was a vein, using a technique known as “IV push.” The assistant apparently missed a vein and hit an artery instead, causing Ms. Levine’s right hand and forearm to turn purple and black in the following weeks, leading to amputation of much of her arm.

The F.D.A.-approved label warned that “inadvertent intra-arterial injection” can cause gangrene requiring amputation, but it did not rule out administering the drug by the “IV push” method.

The justices who sided with Ms. Levine on Wednesday said that “Wyeth could have unilaterally added a stronger warning about IV-push administration” without running afoul of federal regulations. Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer joined Justice Stevens, while Justice Clarence Thomas filed an opinion concurring in the overall judgment.

Justice Samuel A. Alito Jr. wrote a dissent declaring, “This case illustrates that tragic facts make bad law.” Joining him with Chief Justice John G. Roberts Jr. and Justice Antonin Scalia.

Bert Rein, an attorney for Wyeth, said the company “fully complied with federal law” in its labeling, and that the F.D.A. “is in the best position to weight the risks and benefits of a medicine.”

Ms. Levine, now 63, was overjoyed. “Oh, my God. I’m so, so happy,” she told The Associated Press in a telephone interview. “I’m just ecstatic. I’m going to have to sit down.”

    Drug Approval Is Not a Shield From Lawsuits, Justices Rule, NYT, 5.3.2009, http://www.nytimes.com/2009/03/05/washington/05scotus.html

Harvard Medical School

in Ethics Quandary

March 3, 2009
The New York Times
By DUFF WILSON

BOSTON — In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

They say they are concerned that the same money that helped build the school’s world-class status may in fact be hurting its reputation and affecting its teaching.

The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money.

Harvard Medical School’s peers received much higher grades, ranging from the A for the University of Pennsylvania, to B’s received by Stanford, Columbia and New York University, to the C for Yale.

Harvard has fallen behind, some faculty and administrators say, because its teaching hospitals are not owned by the university, complicating reform; because the dean is fairly new and his predecessor was such an industry booster that he served on a pharmaceutical company board; and because a crackdown, simply put, could cost it money or faculty.

Further, the potential embarrassments — a Senate investigation of several medical professors, the F grade, a new state law effective July 1 requiring Massachusetts doctors to disclose corporate gifts over $50 — are only now adding to pressure for change.

The dean, Dr. Jeffrey S. Flier, who says he wants Harvard to catch up with the best practices at other leading medical schools, recently announced a 19-member committee to re-examine his school’s conflict-of-interest policies. The group, which includes three students, is to meet in private on Thursday.

Advising the group will be Dr. David Korn, a former dean of the Stanford Medical School who started work at Harvard about four months ago as vice provost for research. Last year he helped the Association of American Medical Colleges draft a model conflict-of-interest policy for medical schools.

The Harvard students have already secured a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school. (One Harvard professor’s disclosure in class listed 47 company affiliations.)

“Harvard needs to live up to its name,” said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders. “We are really being indoctrinated into a field of medicine that is becoming more and more commercialized.”

David Tian, 24, a first-year Harvard Medical student, said: “Before coming here, I had no idea how much influence companies had on medical education. And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.”

The students say they worry that pharmaceutical industry scandals in recent years — including some criminal convictions, billions of dollars in fines, proof of bias in research and publishing and false marketing claims — have cast a bad light on the medical profession. And they criticize Harvard as being less vigilant than other leading medical schools in monitoring potential financial conflicts by faculty members.

Dr. Flier says that the Harvard Medical faculty may lead the nation in receiving money from industry, as well as government and charities, and he does not want to tighten the spigot. “One entirely appropriate source, if done properly, is industrial funds,” Dr. Flier said in an interview.

And school officials see corporate support for their faculty as all the more crucial, as the university endowment has lost 22 percent of its value since last July and the recession has caused philanthropic contributors to retrench. The school said it was unable to provide annual measures of the money flow to its faculty, beyond the $8.6 million that pharmaceutical companies contributed last year for basic science research and the $3 million for continuing education classes on campus. Most of the money goes to professors at the Harvard-affiliated teaching hospitals, and the dean’s office does not keep track of the total.

But no one disputes that many individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.

The rules, though, do not require them to report specific amounts received for speaking or consulting, other than broad indications like “more than $30,000.” Some faculty who conduct research have limits of $30,000 in stock and $20,000 a year in fees. But there are no limits on companies’ making outright gifts to faculty — free meals, tickets, trips or the like.

Other blandishments include industry-endowed chairs like the three Harvard created with $8 million from sleep research companies; faculty prizes like the $50,000 award named after Bristol-Myers Squibb, and sponsorships like Pfizer’s $1 million annual subsidy for 20 new M.D.’s in a two-year program to learn clinical investigation and pursue Harvard Master of Medical Science degrees, including classes taught by Pfizer scientists.

Dr. Flier, who became dean 17 months ago, previously received a $500,000 research grant from Bristol-Myers Squibb. He also consulted for three Cambridge biotechnology companies, but says that those relationships have ended and that he has accepted no new industry affiliations.

That is in contrast to his predecessor as dean, Dr. Joseph B. Martin. Harvard’s rules allowed Dr. Martin to sit on the board of the medical products company Baxter International for 5 of the 10 years he led the medical school, supplementing his university salary with up to $197,000 a year from Baxter, according to company filings.

Dr. Martin is still on the medical faculty and is founder and co-chairman of the Harvard NeuroDiscovery Center, which researches degenerative diseases, and actively solicits industry money to do so. Dr. Martin declined any comment.

A smaller rival faction among Harvard’s 750 medical students has circulated a petition signed by about 100 people that calls for “continued interaction between medicine and industry at Harvard Medical School.”

A leader of the group, Vijay Yanamadala, 22, said, “To say that because these industry sources are inherently biased, physicians should never listen to them, is wrong.”

Encouraging them is Dr. Thomas P. Stossel, a Harvard Medical professor who has served on advisory boards for Merck, Biogen Idec and Dyax, and has written widely on academic-industry ties. “I think if you look at it with intellectual honesty, you see industry interaction has produced far more good than harm,” Dr. Stossel said. “Harvard absolutely could get more from industry but I think they’re very skittish. There’s a huge opportunity we ought to mine.”

Brian Fuchs, 26, a second-year student from Queens, credited drug companies with great medical discoveries. “It’s not a problem,” he said, pointing out a classroom window to a 12-story building nearby. “In fact, Merck is right there.”

Merck built a corporate research center in 2004 across the street from Harvard’s own big new medical research and class building. And Merck underwrites plenty of work on the Harvard campus, including the immunology lab run by Dr. Laurie H. Glimcher — a professor who also sits on the board of the drug maker Bristol-Myers Squibb, which paid her nearly $270,000 in 2007.

Dr. Glimcher says industry money is not only appropriate but necessary. “Without the support of the private sector, we would not have been able to develop what I call our ‘bone team’ in our lab,” she said at a recent student and faculty forum to discuss industry relationships. Merck is counting on her team to help come up with a successor to Fosamax, the formerly $3 billion-a-year bone drug that went generic last year. But Dr. Marcia Angell, a faculty member and former editor in chief of The New England Journal of Medicine, is among the professors who argue that industry profit motives do not correspond to the scientific aims of academic medicine and that much of the financing needs to be not only disclosed, but banned. Too many medical schools, she says, have struck a “Faustian bargain” with pharmaceutical companies.

“If a school like Harvard can’t behave itself,” Dr. Angell said, “who can?”

    Harvard Medical School in Ethics Quandary, NYT, 3.3.2009, http://www.nytimes.com/2009/03/03/business/03medschool.html?ref=opinion

Abuse Is Found

at Psychiatric Unit

Run by the City

February 6, 2009
The New York Times
By ANEMONA HARTOCOLLIS

The federal government has documented a pattern of sexual and other violent assaults among patients at the psychiatric unit of a city-run Brooklyn hospital where a woman died in June on the floor of the emergency waiting room while staff members ignored her.

After a yearlong investigation, the Department of Justice portrayed the unit at Kings County Hospital Center as a nightmarish place where patients were not treated for suicidal behavior, were routinely subdued with physical restraints and drugs instead of receiving individualized psychiatric treatment, and were frequently abused by other patients.

The details are laid out in a 58-page report to Mayor Michael R. Bloomberg that was made public on Thursday.

The investigators found that the psychiatric service operated like a prison. The report said that instead of meaningful treatment and diagnosis, the patients received frequent visual checks by the staff, and that even when patients were supposedly under watch, violence and attempted suicides occurred.

Among the most serious incidents the report documented were an October brawl among six patients that left one needing surgery, and an autistic patient being forced to perform oral sex in November. The report also included allegations that a woman was raped and that a 14-year-old was forced to engage in oral sex by a 16-year-old.

All four incidents occurred after the highly publicized death of Esmin Green, a Jamaican immigrant with a history of depression, who collapsed on the floor of the emergency waiting room after waiting nearly 24 hours to be seen. A surveillance video showed Ms. Green, 49, lying on the floor for nearly an hour; during that time, a guard came in to check on her by wheeling his chair along, and another staff member prodded her with a foot.

“While perhaps unique in the extent of the harm that resulted, the tragic case of Ms. Green typifies the patterns of inadequate care and treatment,” reads the report, from Loretta King, an acting assistant attorney general, and Benton J. Campbell, the United States attorney in Brooklyn.

The report, a summary account of the federal investigation that resulted from a 2007 lawsuit by the New York Civil Liberties Union and others, found at least three cases, including Ms. Green’s, when employees falsified records to hide their neglect.

The report became public when Alan D. Aviles, president of the city’s Health and Hospitals Corporation, convened a news conference on Thursday to announce that “radical changes” had been made at Kings County, which treats many of the city’s most severely mentally ill. While questioning some details of the report, he admitted that the unit “too often failed” its patients.

At the hospital’s new $153 million building in central Brooklyn, he announced the replacement of its top two administrators and the addition of 200 medical personnel to its 600-member staff.

Mr. Aviles also outlined new protocols for screening emergency-room admissions, using nonuniformed security officers trained in crisis intervention rather than hospital police. Mr. Aviles noted that in Ms. Green’s case, two guards had looked in on her but decided that she was not their responsibility.

“They clearly felt disconnected from the treatment team,” Mr. Aviles said. “This says something very damning about the model.”

Mr. Aviles said the hospital had cut the average time in the emergency department to 8 hours from 27, and that the number of patients waiting seldom exceeded 25 now, compared with 50 or more on occasion.

“It would be disingenuous of me to suggest that we could prevent all such future incidents, but we can do better,” he said.

Stu Loeser, a City Hall spokesman, said that the mayor believed that the Justice Department report raised “serious issues” but that the changes Mr. Aviles announced “go a long way to addressing many of the conditions.”

The Justice Department’s report said conditions at the psychiatric unit were “highly dangerous and require immediate attention.” It added: “Substantial harm occurs regularly due to K.C.H.C.’s failure to properly assess, diagnose, supervise, monitor and treat its mental health patients.”

The report said that many patients were admitted with “catch-all” diagnoses and that the staff used “boilerplate forms and checklists” rather than writing “individualized narratives.”

The report said that patients were often left in restraints for the two-hour limit even though they had changed their behavior, suggesting that the confinement was punishment rather than therapy. And investigators found it was common to administer injections of more than one antipsychotic medication simultaneously, despite the risk of side effects and overdosing.

In one case, a patient’s treatment plan did not address his obesity, high blood pressure and diabetes, until he had a stroke, according to the report.

    Abuse Is Found at Psychiatric Unit Run by the City, NYT, 6.2.2009, http://www.nytimes.com/2009/02/06/nyregion/06kings.html?hp

Editorial

Your E-Health Records

February 1, 2009
The New York Times

As part of the stimulus package, $20 billion will be pumped into the health care system to accelerate the use of electronic health records. The goal is both to improve the quality and lower the costs of care by replacing cumbersome paper records with electronic records that can be easily stored and swiftly transmitted.

The idea is sound, but it also raises important questions about how to ensure the privacy of patients. Fortunately, the legislation would impose sensible privacy protections despite attempts by business lobbyists to weaken the safeguards.

With paper records the opportunities for breaches are limited to over-the-shoulder glimpses or the occasional lost or stolen files. But when records are kept and transferred electronically, the potential for abuse can become as vast as the Internet.

Electronic health records that can be linked to individual patients are already protected by laws that apply primarily to hospitals, doctors, nursing homes, pharmacists, laboratories and insurance plans. The stimulus bill that has passed in the House, and a similar bill awaiting approval in the Senate, would strengthen the privacy requirements and apply them more directly to “business associates” of the providers, like billing and collection services or pharmacy benefit managers, that have access to sensitive data but are not readily held accountable for any misuse.

The potential for harm was spelled out by the American Civil Liberties Union in a recent letter to Congress. Employers who obtain medical records inappropriately might reject a job candidate who looks expensive to insure. Drug companies with access to pharmaceutical records might try to pressure patients to switch to their products. Data brokers might buy medical and pharmaceutical records and sell them to marketers. Unscrupulous employees with access to electronic records might snoop on the health of their colleagues or neighbors.

The bills pending in Congress would go a long way toward preventing such abuses. They would outlaw the sale of any personal health information without the patient’s permission, mandate audit trails to help detect inappropriate access, and require that patients be notified whenever their records are lost or used for an unauthorized purpose. They would also beef up the penalties for noncompliance and allow state attorneys general to help enforce the rules — a useful backup in case the federal government falls down on the job. The House version would also encourage the use of protective technologies, like encryption, to protect personal medical information that will be transmitted.

Health insurance plans and some disease management groups are complaining that the new requirements would impose administrative burdens that could actually impede the use of electronic records and interfere with coordination of care. They want to ease the marketing restrictions, notify patients only if security breaches are harmful, and keep the attorneys general out of the enforcement role.

It should be possible through implementing regulations to fine-tune the privacy requirements so that they do not disrupt patient care. Congress must make every effort to ensure that patients’ privacy is protected.

    Your E-Health Records, NYT, 1.2.2009, http://www.nytimes.com/2009/02/01/opinion/01sun2.html?ref=opinion

Pfizer Agrees to Pay $68 Billion

for Rival Drug Maker Wyeth

January 26, 2009
The New York Times
By ANDREW ROSS SORKIN
and DUFF WILSON

The board of Pfizer, the world’s largest drug maker, agreed to acquire a rival, Wyeth, for $68 billion, the companies announced Monday.

The deal, if completed, would not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government.

It will also be the first big merger backed by Wall Street in months. While credit has been notoriously tight of late, five banks have agreed to lend Pfizer $22.5 billion to pay for the deal. Pfizer, which has roughly $26 billion in cash, would finance the remainder through a combination of cash and stock.

If completed as planned, the transaction would be the biggest merger since AT&T and BellSouth combined in a $70 billion deal in March 2006, according to the research firm Capital IQ.

Pfizer also said Monday that its net income for the fourth quarter dropped 90 percent from the period a year ago, citing a charge to resolve inquires into its off-label promotional practices. In its statement, it also said that it planned to its work force by about 10 percent and reduce the number of manufacturing sites. The company also said that it would cut its dividend.

Pfizer earned $268 million, or 4 cents a share, in the fourth quarter, down from $2.72 billion, or 40 cents a share, in the period a year ago. Revenue dropped 4 percent, to $12.35 billion. Excluding the $2.3 billion to settle the marketing inquiry, Pfizer had a profit of 65 cents a share. Analysts surveyed by Thomson Reuters had forecast 59 cents.

“The combination of Pfizer and Wyeth will meaningfully deliver Pfizer’s strategic priorities in a single transaction,” the Pfizer’s chief executive, Jeffrey B. Kindler, said in a statement Monday. “Our combined company will be one of the most diversified in the industry and will benefit from complementary patient-centric units that match speed with the benefits of a global company’s scale and resources.”

The merger almost came unhinged at the 11th hour. While the boards of both companies agreed to the broad outlines of the deal and its price before the weekend, these people said, one issue was still a sticking point: whether Pfizer would be allowed to back out of the deal if the economy worsened or Wyeth’s prospects faded.

In better times, deals often falter on matters of strategy or price. But in this case, because of the ailing economy, Pfizer has agreed to pay a staggering breakup fee, $4.5 billion, if it does not complete the deal under certain circumstances — if, for example, its credit rating drops and it can no longer finance the deal. That is almost twice the typical breakup fee for a deal of this size.

If the acquisition is completed, it may demonstrate that Wall Street is willing to lend again, at least to the nation’s top companies with the best credit ratings.

“If banks need to send a message that they’re loaning, they want to be loaning to this quality of company,” said Catherine Arnold, an analyst at Credit Suisse.

Pfizer’s bid is being financed by four banks that received federal bailout money: Goldman Sachs, JPMorgan Chase, Citigroup and Bank of America, the people involved in the deal said. Such banks have been criticized for not doing more lending since they received the government aid.

Barclays, which acquired Lehman Brothers out of bankruptcy in the fall, is also providing financing, these people said.

Pfizer appears to be taking advantage of the bad market for credit to buy Wyeth at a lower price than it might fetch if competing bids were to emerge, which analysts do not expect.

“They have a unique opportunity now because not everybody can get that capital,” said Barbara Ryan, an analyst at Deutsche Bank.

Because the combined company is expected to generate more than $20 billion in cash a year, Ms. Ryan said, “even when they borrow money, they will still have plenty of revenue.”

Under the terms of the deal, Pfizer would pay $50.19 a share for the company — $33 a share in cash and 0.985 Pfizer shares worth $17.19 a share based on Pfizer’s closing price on Friday. That is roughly a 29 percent premium over the share price before word of the deal leaked on Friday.

Both companies’ boards of directors approved the deal.

Wyeth’s management team would depart, the people involved in the negotiations said. Pfizer is also planning to cut its quarterly dividend in half to 16 cents, these people said, in an effort to maintain its credit rating.

After news reports disclosed the talks on Friday, investors applauded the possibility of a deal. Shares of Wyeth rose $4.91, or 12.6 percent, to close at $43.74. Pfizer climbed 24 cents, or 1.4 percent, to close at $17.45.

Pfizer expects to save $4 billion annually by combining with Wyeth; those savings will be phased in over three years.

Mr. Kindler of Pfizer, first approached Wyeth last spring with a phone call, people involved in the talks said. The negotiations heated up in the summer but appeared to collapse when the banking system went into a tailspin in September and October.

Since then, there were several brief moments when it appeared the deal would move ahead, but then the talks would fall apart once again, usually over financing, these people said. It was apparently only within the last week or so that the financing commitment came together.

For Mr. Kindler, a lawyer who came to Pfizer from McDonald’s, the deal may be a job-saver. His and the company’s most pressing challenge has been the impending expiration of patent rights to the cholesterol-lowering drug Lipitor — which accounted for a quarter of the company’s 2007 revenue of $48 billion and remains the best-selling drug in the world. The patent ends in 2011.

Still, even with the Wyeth deal, much would remain undone for Pfizer as it faces product, patent and pipeline problems for other drugs as well.

“It’s not just Lipitor,” Ms. Arnold wrote last year in a report to investors. Pfizer faces a run of 14 patent expirations through 2014, which would add up to lost revenue of about $35 billion as those drugs give way to cheap generics, according to Ms. Arnold. Pfizer’s patent problem is not unique among the big drug makers. Merck, Bristol Myers Squibb and Eli Lilly are all facing their own patent losses in the next five years. “Everybody’s staring at the same challenges down the road,” Ms. Ryan said.

She said that Mr. Kindler, who became chief executive in July 2006, had probably not been in a position to make a play for a company like Wyeth until after he had cut costs, revamped Pfizer’s core business and accepted the reality that the research pipeline was not producing blockbusters. “Hope springs eternal from the research pipeline,” Ms. Ryan said.

As part of the deal with Wyeth, both companies will have to repatriate tens of billions of dollars back into the United States, which could have a high tax cost. Pfizer reported $25.3 billion in revenue, 52.2 percent of its total, from overseas operations in 2007, according to securities filings.

If foreign profits were repatriated to the United States, Pfizer would have to pay the difference between the tax paid in the foreign country, as low as 5 percent in Ireland, for example, and the 35 percent tax rate in the United States.

Ms. Arnold said some tax penalties might be expected, but could be reduced by doing some of the buying and selling overseas.

“The experts that we’ve spoken to have very definitely said you can use offshore cash to buy offshore assets, and Pfizer and Wyeth both have very significant offshore subsidiaries that they place cash in,” Ms. Arnold said. For example, she said, “Pfizer Ireland can use its cash to buy Wyeth Ireland or Wyeth Singapore.”

Wyeth, with sales of about $23 billion for the 12 months that ended Sept. 30, has about $2.7 billion in cash and liquid assets, according to David S. Moskowitz, an analyst at Caris & Company, an investment bank.

Pfizer was advised by Goldman, JPMorgan and Barclays; Wyeth was advised by Morgan Stanley and Evercore Partners.

Erik Gordon, a professor at the Ross School of Business at the University of Michigan who follows biomedical industries, said Pfizer and Wyeth were a great fit that made the deal creditworthy.

First, because Pfizer has so much cash, the deal does not have to be highly leveraged with debt, Mr. Gordon said. Second, the two companies have enough overlap that they can achieve considerable saving through consolidating duplicate operations and cutting costs. And finally, parts of a combined operation could be spun off to raise money.

Mr. Gordon pointed to the animal health businesses of both companies — which, considered together, accounted for $2.8 billion in revenue and about $600 million in profit in the first nine months of 2008.

“They could sell that business for billions of dollars to either pay down the debt or service the debt,” he said. In addition, he said Pfizer could resell Wyeth’s consumer products business. He added: “This deal is the rare thing. This’ll be the only money investment bankers make in a while.”

    Pfizer Agrees to Pay $68 Billion for Rival Drug Maker Wyeth, NYT, 26.1.2009, http://www.nytimes.com/2009/01/26/business/26drug.html?hp

F.D.A. Approves a Stem Cell Trial

January 23, 2009
The New York Times
By ANDREW POLLACK

In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells.

Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Obama, who has pledged to remove some of the financing restrictions placed on the field by President George W. Bush.

The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data.

Thomas B. Okarma, Geron’s chief executive, said Thursday that he did not think that the Bush administration’s objections to embryonic stem cell research played a role in the F.D.A.’s delaying approval.

“We really have no evidence,” Dr. Okarma said, “that there was any political overhang.”

But others said they suspected it was more than a coincidence that approval was granted right after the new administration took office.

“I think this approval is directly tied to the change in administration,” said Robert N. Klein, the chairman of California’s $3 billion stem cell research program. He said he thought the Bush administration had pressured the F.D.A. to delay the trial.

Mr. Klein called the approval of the first human trial of this sort “an extraordinary benchmark.”

Stem cells derived from adults and fetuses are already being used in some clinical trials, but they generally have less versatility than embryonic stem cells in terms of what tissue types they can form.

The F.D.A. approval comes a little more than 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin, in work financed by Geron.

Because the cells can turn into any type of cell in the body, the theory is they may one day be able to provide tissues to replace worn-out organs or nonfunctioning cells to treat diabetes, heart attacks and other diseases. The field is known as regenerative medicine.

The Bush administration restricted federal financing for research on embryonic stem cells because creation of the cells entails the destruction of human embryos.

Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries.

The study is a so-called Phase I trial, aimed mainly at testing the safety of the therapy. There would still be years of testing and many hurdles to overcome before the treatment would become routinely available to patients.

Geron, which is based in Menlo Park, Calif., said that it had identified up to seven medical centers for the trial but that those sites must first get permission from their own internal review boards to participate.

Even as some researchers hailed the onset of clinical trials, others expressed trepidation that if the therapy proves unsafe — or even if it is safe but does not work — it could cause a backlash that would set the field back for years.

“It would be a disaster, a nightmare, if we ran into these kinds of problems in this very first trial,” said Dr. John A. Kessler, the chairman of neurology and director of the stem cell institute at Northwestern University.

Dr. Kessler, whose own daughter was paralyzed from the waist down in a skiing accident, said he thought Geron’s therapy was not the ideal candidate for the first trial. He said results showing the therapy worked in moderately injured animals might not apply to more seriously injured people.

“We really want the best trial to be done for this first trial, and this might not be it,” he said.

Dr. Okarma of Geron emphasized that the purpose of the first trial was safety, so that lack of efficacy should not be a problem. While researchers will also look for signs the treatment works, he said, the best that could be hoped for would be some slight restoration of function that could then be enhanced through physical therapy.

“We don’t expect to take someone who is completely paralyzed from the waist down and have them dance six months later,” he said. If the first trial shows safety, the company would then hope to test higher doses of cells and treat patients with less severe injuries, he said.

Geron’s therapy involves using various growth factors to turn embryonic stem cells into precursors of neural support cells called oligodendrocytes, which are then injected into the spinal cord at the site of the injury.

The hope is that the injected cells will help repair the insulation, known as myelin, around nerve cells, restoring the ability of some nerve cells to carry signals. There is also some hope that growth factors produced by the injected cells will spur damaged nerve cells to regenerate.

The therapy was developed in collaboration with Hans Keirstead of the University of California, Irvine. He has shown videos of paralyzed rats that were able to walk again, albeit imperfectly, after receiving the therapy. Those videos helped persuade California voters to approve the $3 billion stem cell research program in 2004.

The main safety concern is that if raw embryonic cells are put into the body, they can form tumors. Even though most such tumors do not spread like other cancers, any unwanted growth in the spinal cord can further damage nerves.

“It’s not ready for prime time, at least not in my mind, until we can be assured that the transplanted stem cells have completely lost the capacity for tumorogenicity,” said Dr. Steven Goldman, chairman of neurology at the University of Rochester. He was a member a committee convened by the F.D.A. last April to examine the safety aspects of trials using therapies from embryonic stem cells.

Dr. Okarma said Geron had done numerous studies showing that its cells did not contain residual embryonic cells and did not form tumors in animals even after a year. It submitted 22,000 pages of data to the F.D.A., perhaps the largest application ever for permission to begin a clinical trial.

The embryonic stem cell line used by Geron is one of the oldest ones and was therefore eligible for federal financing under the Bush administration’s policy, Dr. Okarma said.

Nevertheless, Geron paid for its own work, spending $45 million to prepare its F.D.A. application.

Geron, which was formed in 1990 as an antiaging company, is still in the development stage and is not yet profitable, having lost about $500 million since its inception. Besides working on stem cells, it is testing drugs for cancer that influence telomeres, the caps on the ends of chromosomes that help control the aging of cells. Geron’s market value is about $400 million.

While the Bush administration’s policy did not impede the company’s application at the F.D.A., Dr. Okarma said, it did slow progress for the field in general by making it hard for academics to do research.

“It is the private sector that has kept the technology alive so that it can see the light of day in a clinical trial,” he said.

Mr. Klein of the California stem cell program said he thought the next trial might be of a treatment for macular degeneration, an eye disease, that is being developed in Britain.

In the last couple of years, some attention has turned away from embryonic stem cells to a newer technique that allows a patient’s own skin cells to be turned into a cell resembling such embryonic cells.

That might do away with the need for embryos. And the resulting tissue made from those cells would match the patient, doing away with the need for immune suppression to prevent rejection of the transplant. Geron said its trial would require only temporary use of low doses of immune-suppressing drugs.

But the newer technique involves putting genes into the skin cells using viruses, which also raises a risk of cancer.

    F.D.A. Approves a Stem Cell Trial, NYT, 24.1.2009, http://www.nytimes.com/2009/01/23/business/23stem.html?hp

Alexandra Falagara

The Abortion Choices of Poor Women

NYT

12.1.2009

http://www.nytimes.com/2009/01/12/opinion/l12abort.html

Letters

The Abortion Choices of Poor Women

January 12, 2009
The New York Times

To the Editor:

Re “For Privacy’s Sake, Risking Do-It-Yourself Abortion” (news article, Jan. 5):

Throughout history, women have tried many ways to end an unwanted pregnancy. Your article underscores the fact that after 36 years of legal abortion, some women still struggle to obtain reproductive health care because they don’t understand or trust the American medical system.

In my Washington Heights clinic in northern Manhattan, I see at least one patient every week who has tried to end a pregnancy on her own. When lack of information, poverty or stigma overwhelm pregnant women, some take matters into their own hands.

We can do better to educate women about their legal options. While they can use misoprostol to end a pregnancy, there are safer and more effective methods.

As we approach the anniversary of Roe v. Wade, physicians need to remember that reproductive health care remains a challenge, even in New York City. We must work within our communities to ensure that women know how to navigate the health care system.

Anne Davis
New York, Jan. 5, 2009

The writer is medical director of Physicians for Reproductive Choice and Health.

•

To the Editor:

In your article, abortion is called “safe, legal and inexpensive.”

While this common procedure is safe and is mostly legal, despite aggressive regulation, it is not inexpensive. An abortion at 10 weeks’ gestation costs $523 on average, often out of pocket.

To term this “inexpensive,” especially in the current economy, is ludicrous.

Many women struggle to raise the money for an abortion as their pregnancy progresses. Sixty-seven percent of poor women having an abortion report that they would have preferred to have an earlier procedure.

Regarding abortion’s “widespread availability,” that is perhaps true for some in New York, but not for all women.

Self-induced abortion does raise questions about women’s experience, but glossing over the challenges of gaining access to abortion services does nothing to answer these questions. It neither reflects the reality of abortion delivery nor the reality of women’s lives.

Melanie Zurek
Silvia Henriquez
Cambridge, Mass., Jan. 6, 2009

The writers are executive directors of, respectively, the Abortion Access Project and the National Latina Institute for Reproductive Health.

•

To the Editor:

Your article points out that for some women abortion care has not changed in more than 100 years.

Using the code “I need to bring down my period,” women in Washington Heights ask the pharmacist for an abortion drug.

In the 1800s, newspapers and the religious press in the United States carried ads for medicines that would cure “blocked” menstruation. Such ads stated that the product should not be used by married ladies. This was a code that the product could cause an abortion, thus telling women who wanted to end a pregnancy to buy the product.

On the other hand, this is the 21st century. Some teenagers are going to the Internet for instructions on a do-it-yourself abortion. I went online to see what information was out there and was horrified by what I found.

On one site the reader is instructed to insert implements vaginally and then head for the emergency room once the hemorrhaging starts. But as a pediatric nurse practitioner in Washington Heights, I know there are clinics that provide safe, confidential care for teenagers.

Confidential care is the law of the state. One would hope that pharmacists would tell women about these facilities. New York women do not have to live with 19th-century care. Poor women in other states may not have a choice.

Carol Roye
Pleasantville, N.Y., Jan. 5, 2009

The writer is assistant dean (acting) for research and a professor of nursing at Hunter College.

•

To the Editor:

Your article is an excellent reminder of the struggles facing poor women who seek basic reproductive health care in this country. Because of a law called the Hyde Amendment, which was first enacted in 1976 and renewed each year since, women on Medicaid are not covered for the cost of an abortion.

Unlike other basic health needs for men and women, this procedure, which nearly one-third of all women in the United States will have by the end of their reproductive years, is specifically carved out of coverage. For poor women in Washington Heights, paying $30 for a risky and illegal drug is much more realistic than paying several hundred dollars (or much more) for a legal abortion out of their own pockets.

If President-elect Barack Obama is serious about improving the health of poor women, one of his first agenda items should be the repeal of the Hyde Amendment. In the meantime, poor women will, at best, turn to private assistance through local abortion funds, or, at worst, turn to risky medicine that is the modern equivalent of the back-alley abortion.

David S. Cohen
Philadelphia, Jan. 5, 2009

The writer is an associate professor at the Drexel University Earle Mack School of Law and a board member of the Women’s Medical Fund in Philadelphia.

•

To the Editor:

The article about Dominican women in New York who use medication to give themselves abortions highlights the need for better information.

In some states, legal residents and/or undocumented immigrants may be eligible for medical programs that would pay for abortion or contraception. Where women have no access to publicly funded medical care, they may still find assistance from a local abortion fund or from the National Network of Abortion Funds, which helps women who cannot afford an abortion to obtain safe pregnancy termination services.

Access to information about these resources may not be enough to combat the fear of deportation and social censure, but it is a start.

Rachel Roth
Arlington, Mass., Jan. 7, 2009

The writer is co-author of a report about abortion financing.

    The Abortion Choices of Poor Women, NYT, 12.1.2009, http://www.nytimes.com/2009/01/12/opinion/l12abort.html

For Privacy’s Sake,

Taking Risks to End Pregnancy

January 5, 2009
The New York Times
By JENNIFER 8. LEE
and CARA BUCKLEY

Amalia Dominguez was 18 and desperate and knew exactly what to ask for at the small, family-run pharmacy in the heart of Washington Heights, the thriving Dominican enclave in northern Manhattan. “I need to bring down my period,” she recalled saying in Spanish, using a euphemism that the pharmacist understood instantly.

It was 12 years ago, but the memory remains vivid: She was handed a packet of pills. They were small and white, $30 for 12. Ms. Dominguez, two or three months pregnant, went to a friend’s apartment and swallowed the pills one by one, washing them down with malta, a molasseslike extract sold in nearly every bodega in the neighborhood.

The cramps began several hours later, doubling Ms. Dominguez over, building and building until, eight and a half hours later, she locked herself in the bathroom and passed a lifeless fetus, which she flushed.

The pills were misoprostol, a prescription drug that is approved by the Food and Drug Administration for reducing gastric ulcers and that researchers say is commonly, though illegally, used within the Dominican community to induce abortion. Two new studies by reproductive-health providers suggest that improper use of such drugs is one of myriad methods, including questionable homemade potions, frequently employed in attempts to end pregnancies by women from fervently anti-abortion cultures despite the widespread availability of safe, legal and inexpensive abortions in clinics and hospitals.

One study surveyed 1,200 women, mostly Latinas, in New York, Boston and San Francisco and is expected to be released in the spring; the other, by Planned Parenthood, involved a series of focus groups with 32 Dominican women in New York and Santo Domingo. Together, they found reports of women mixing malted beverages with aspirin, salt or nutmeg; throwing themselves down stairs or having people punch them in the stomach; and drinking teas of avocado leaf, pine wood, oak bark and mamon fruit peel.

Interviews with several community leaders and individual women in Washington Heights echoed the findings, and revealed even more unconventional methods like “juice de jeans,” a noxious brew made by boiling denim hems.

“Some women prefer to have a more private experience with their abortion, which is certainly understandable,” said Dr. Daniel Grossman, an obstetrician with Ibis Reproductive Health in San Francisco, which joined Gynuity Health Projects in New York in conducting the larger study. “The things they mention are, ‘It is easier.’ It was recommended to them by a friend or a family member.”

Dr. Carolyn Westhoff, an obstetrician at NewYork-Presbyterian/Columbia University Medical Center, said the trend fits into a larger context of Dominicans seeking home remedies rather than the care of doctors or hospitals, partly because of a lack of insurance but mostly because of a lack of trust in the health care system. “This is not just a culture of self-inducted abortion,” she said. “This is a culture of going to the pharmacy and getting the medicine you need.”

Physicians say that women can obtain the pills either through pharmacies that are willing to bend the rules and provide the medicine without a prescription or by having the drugs shipped from overseas.

It is impossible to know how many women in New York or nationwide try to end their pregnancies themselves, but in the vibrant, socially conservative Dominican neighborhoods of Upper Manhattan, the various methods are passed like ancient cultural secrets. In a study of 610 women at three New York clinics in largely Dominican neighborhoods conducted eight years ago, 5 percent said they had taken misoprostol themselves, and 37 percent said they knew it was an abortion-inducing drug. Doctors and community leaders say they have not seen any signs of the phenomenon disappearing, which they find worrisome because of concerns about the drug’s effectiveness and potential side effects.

Sold under the brand name Cytotec, misoprostol is approved to induce abortion when taken with mifepristone, or RU-486; doctors also sometimes use it to induce labor, though it is not approved for that use. A spokesman for Pfizer, which manufacturers Cytotec, declined to comment beyond saying that the company does not support the off-label use of its products and noting that the label includes “F.D.A.’s strongest warning against use in women who are pregnant.”

That warning, in capital letters, also notes that the drug “can cause abortion.”

But it does not always do so, not least because notions of how best to use it vary from inserting several pills into the vagina to letting them dissolve under the tongue. The side effects can be serious, and include rupture of the uterus, severe bleeding and shock.

“We do worry because we don’t know where women are getting the instructions from,” said Jessica Gonzalez-Rojas of the National Latina Institute for Reproductive Health, which was also a partner on the Ibis study. “We imagine that there is misinformation on how to take it, which is why it could be hit or miss.”

In 2007 in Massachusetts, an 18-year-old Dominican immigrant named Amber Abreu took misoprostol in her 25th week of pregnancy and gave birth to a 1-pound baby girl who died four days later; a judge sentenced her in June to probation and ordered her into therapy. In South Carolina in February, a Mexican migrant farm worker, Gabriela Flores, pleaded guilty to illegally performing an abortion and was sentenced to 90 days in jail for taking misoprostol while four months pregnant in 2004. A Virginia man, Daniel Riase, is serving a five-year prison sentence after pleading guilty in 2007 to slipping the pills into his pregnant girlfriend’s glass of milk.

Researchers studying the phenomenon cite several factors that lead Dominican and other immigrant women to experiment with abortifacients: mistrust of the health-care system, fear of surgery, worry about deportation, concern about clinic protesters, cost and shame.

“It turns an abortion into a natural process and makes it look like a miscarriage,” said Dr. Mark Rosing, an obstetrician at St. Barnabas Hospital in the Bronx who led the 2000 study, which was published in the Journal of the American Medical Women’s Association. “For people who don’t have access to abortion for social reasons, financial reasons or immigration reasons, it doesn’t seem like this horrible thing.”

Ms. Dominguez, for her part, said she had no insurance or money to pay for an abortion, and could not fathom getting one for fear her mother would find out. One of her friends had spent $1,200 on an abortion that left her with a uterine infection, and another friend endured the procedure without anesthesia, she said. In addition, Washington Heights is a tightknit community where abortion — as well as birth control — is shunned; if Ms. Dominguez were spotted entering a clinic, rumors could fly.

“There are scary moments, and you got to have a friend right next to you,” said Ms. Dominguez, now 30 and a mother of four. “It’s cheap but dangerous. Certain people are more delicate than others. But afterwards, I felt relief.”

A friend of Ms. Dominguez’s said her stepsister took the pills last year because she was in the country illegally, and worried that a doctor might turn her in. “She was just scared,” the woman said, speaking on the condition that her name not be published to protect the stepsister’s privacy. “She had no papers, no insurance, no nothing.”

The woman went to a free clinic afterward to make sure the pills had worked (they had). Health care workers and other community leaders say such visits are how they discovered widespread illicit use of the drug as well as homemade potions.

Dr. Rosing said he learned about Cytotec during his residency at NewYork-Presbyterian/Columbia hospital in Washington Heights, where he saw a lot of Dominican immigrants with incomplete abortions in the emergency room. They spoke of taking the “star pill,” a nickname for the hexagonal shape of one form of misoprostol. He suspected “that has to be the tip of the iceberg,” he said, “and it was.”

The pills allow pregnant women a degree of denial over what is taking place. Like Ms. Dominguez, many women in the neighborhood talk about the need to bring on — or “down” — their periods, not abortion. Afterward, they might tell doctors or relatives they had lost the baby.

The Planned Parenthood study concluded that women in both nations “seemed to see inducing the termination of pregnancy, or abortions, as a part of the reality of their lives,” in a community where, as one interview subject put it, “we are all doctors.” The report noted that in a culture steeped in machismo, birth control is generally seen as the woman’s responsibility.

“If I introduce the condom into a relationship, I’m basically saying I’ve had somebody else, and I’ve not been faithful to you,” said Haydee Morales, a vice president at Planned Parenthood of New York.

Debralee Santos, program director at Casa Duarte, a community arts organization in Washington Heights, said that while she had never had reason to distrust medical professionals, she understood the apprehensions that kept other women from seeking them out. “I get it, I really do,” she said.

“It’s a community that, even as it comes of age, always relies on itself first,” explained Ms. Santos, who was born in the United States to immigrant parents. “Women, in particular, continue to help each other in ways that speak to tradition and solidarity.”

Ms. Dominguez, who volunteers at Casa Duarte and is known as Flaca, Spanish for skinny, did not want her name or photograph published at first. But after some thought, she decided to allow it so more people would learn about the trap many pregnant Dominican women feel they are in.

“It’s a health risk,” she said. “There’s a lot of girls in situations like that, and they’re overwhelmed.”

For Privacy’s Sake, Taking Risks to End Pregnancy, NYT, 5.1.2009,
    http://www.nytimes.com/2009/01/05/nyregion/05abortion.html