HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Thursday, May 31, 2007

TB Quarantine

I am sure that many people have been following the rather frightening saga of the man, Andrew Speaker (and yes, he is an attorney (gulp!)), with drug-resistant TB now under quarantine after taking several flights, some transatlantic.  Here is the basic background:

A man with a rare and dangerous form of tuberculosis ignored doctors' advice and took two trans-Atlantic flights, leading to the first U.S. government-ordered quarantine since 1963, health officials said Tuesday.  The man, whom officials did not identify, is at Atlanta's Grady Memorial Hospital in respiratory isolation. . . .

In an interview with the Atlanta Journal-Constitution, the man said he had traveled to Europe for his wedding and honeymoon and expressed frustration with how he said the CDC handled the situation.  "I didn't want to put anybody at risk," the man, who declined to be identified because of the stigma surrounding his condition, told The Atlanta Journal-Constitution. "We just wanted to come home and get treatment."

The infected man flew from Atlanta to Paris on May 12 aboard Air France Flight 385. He returned to North America on May 24 aboard Czech Air Flight 0104 from Prague to Montreal. The man then drove into the United States at the Champlain, N.Y., border crossing.

The man had been advised by health officials in early May not to travel to Europe. "He was told traveling is against medical advice," said Dr. Steven Katkowsky, director of the Fulton County Department of Health & Wellness.

The man conceded that the health department advised him not to travel, but he didn't want to call off his wedding, he told the Journal-Constitution. The CDC never told him he couldn't go, he said.  When the man arrived back in the United States, he voluntarily went to a New York hospital, then was flown by the CDC to Atlanta. He is not facing prosecution, health officials said.

The man said the CDC contacted him in Rome during his honeymoon, telling him that he had to return home and that he had to turn himself in to Italian authorities, be isolated and be treated there, the Journal-Constitution reported.

Here is a brief update about Mr. Speaker, now in Denver receiving treatment, and his father-in-law, a CDC employee:

Speaker's father-in-law works for the Centers for Disease Control and Prevention in Atlanta, an agency spokesman said Thursday.  The father-in-law, Robert C. Cooksey, is a microbiologist who has conducted research on tuberculosis for the National Center for Infectious Diseases, according to a CDC biography posted on the agency's Web site.

CNN affiliate WSB-TV reported that Cooksey gave his son-in-law, Speaker, "fatherly advice" after he found out his son-in-law had contracted the infectious disease, but did not advise him in any official capacity.

Concurring opinions' Steve Vladek has some thoughts on the law of quarantine and whether fellow travelers may sue the now-quarantined passenger.   (Thanks Professor O'Donnell for the link).  Other information and commentary can be found here, here and here.  Unfortunately, it doesn't look like the United States had a plan on how to deal with this type of situation and I am sure that the rest of the world is excited about having Americans traveling to visit them this summer.

May 31, 2007 | Permalink | Comments (0) | TrackBack (0)

No Private Testing for Mad Cow Disease

Wos - just when you think that the food supply cannot get any worse -- the government argues against the testing of cattle for mad cow disease . . . .  Here is the brief excerpt from the Wall Street Journal:

The Bush administration said it will fight a ruling allowing meatpackers to test their animals for mad-cow disease. The Agriculture Department tests fewer than 1% of slaughtered cows for the disease. Kansas-based Creekstone Farms Premium Beef wants to test all of its cows. A federal judge ruled in March that such tests must be allowed. The Agriculture Department argues that widespread testing could lead to a false positive. Larger meat companies say if Creekstone tests its meat and advertises it as safe, they might be expected to perform the expensive test, too.

You can find more about the original case, Creekstone Farms Premium Beef v. US Department of Agriculture, as well as a link to the decision, here.  There is more commentary from Firedoglake as well.

May 31, 2007 | Permalink | Comments (0) | TrackBack (0)

Friday, May 25, 2007

FDA Approves new "No-Period" Contraceptive Pill

Earlier this week, the Food and Drug Administration (FDA) approved Lybrel, a pill that stops a woman from having her period indeflintely.  The New York Times reports,   

The first birth-control pill meant to put a stop to a woman’s monthly period indefinitely has won federal approval, the manufacturer said on Tuesday.  When taken daily, the pill, called Lybrel and made by Wyeth, can halt women’s menstrual periods indefinitely and prevent pregnancies.

It is the latest oral contraceptive approved by the Food and Drug Administration to depart from the 21-days-on, 7-days-off regimen that had been standard since birth-control pill sales began in the 1960s, and is the first made to put off periods altogether when taken without a break.

Wyeth, based in Madison, N.J., plans to start Lybrel sales in July. The company said it had not determined a price. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

There has been some mixed responses to this approval, some responses appearing quite odd to me.  Here is one reaction by Ms. Unruh, president of the National Abstinence Clearinghouse, as well as some responses by other bloggers.  I must admit, my reaction was -- how safe is this new drug?  -- The same response that I would have for any drug approved by the current FDA.  I also wonder if insurance companies plan to cover Lybrel.

May 25, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, May 24, 2007

Sicko

Michael Moore's new film, Sicko, which details the many problems with the American health care system is getting a lot of rave reviews.   Here is what Salon.com had to say about the film,

"Sicko" does not display Moore at his most cinematically inventive or imaginative. It presents a TV-documentary-style parade of episodes, characters and settings, bouncing from various American cities to Canada, Britain, France and Cuba (and yes, don't worry, we'll get to that). Moore plays a far smaller personal role in this film, appearing only occasionally in his comic-relief role as the clueless buffoon who can't seem to grasp that healthcare in all those other countries is free, or virtually so. When he's eating dinner with a group of Americans living in Paris who begin to list all the things they can have as free or nearly free entitlements -- not just healthcare but an emergency doctor who makes house calls; not just childcare but a part-time in-home nanny -- Moore puts his hands over his ears and begins singing "La la la la la." (If you have kids or any kind of chronic family health problems, your reactions might include weeping in despair, slitting your wrists or booking a one-way ticket.)

Still, there is no mistaking the passion and political intelligence at work in "Sicko." It's both a more finely calibrated film and one with more far-reaching consequences than any he's made before. Moore is trying to rouse Americans to action on an issue most of us agree about, at least superficially. You may know people who will still defend the Iraq war (although they're less and less eager to talk about it). But who do you know who will defend the current method of healthcare delivery, administered by insurance companies whose central task is to minimize cost and maximize shareholder return? Americans of many different political stripes would probably share Moore's conclusions at the press conference: "It's wrong and it's immoral. We have to take the profit motive out of healthcare. It's as simple as that."

I hope this film has a big impact (although I thought Moore's last film might influence the election so what do I know).   Here is the movie trailer.

May 24, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 23, 2007

Data-Mining, Privacy, and the Drug Companies

I hadn't been following closely this New Hampshire case, IMS Health Incorporated, et. al. v. Kelly Ayotte, Attorney General, New Hampshire, but was disappointed to learn its outcome.  The case involved a New Hampshire statute that "bars data-miners from using patients' prescription drug information to directly market pharmaceuticals to physicians—an industry practice called detailing."   The federal court found the statute unconstitutional.  Modern Healthcare Online reports New Hampshire's response to the decision:

"The state has a substantial interest in protecting the privacy of New Hampshire physicians, defending the sanctity of the doctor-patient relationship and reducing healthcare costs," said Attorney General Kelly Ayotte in a written statement Thursday. "Healthcare costs in the state of New Hampshire are skyrocketing. The Prescription Information Law protects the state's interests and the interests of New Hampshire's physicians and citizens, which strongly outweigh the pharmaceutical industry's interest in increased profits."

Here is a further update from Majikthise on that state's efforts to curb data-mining of prescription drug scripts by pharmaceutical companies.

Three weeks ago, a federal judge ruled that New Hampshire's ban on drug company data mining was unconstitutional.

As I learned when I worked in pharmaceutical advertising, the prescribing report is one of the most powerful tools in any rep's arsenals. Drug salesmen walk into doctors' offices knowing exactly how many prescriptions that doctor for which drugs. Often, doctors don't even realize that the rep has their complete prescribing stats. The reps use this information to strong-arm doctors into prescribing more of their medications. . . . .

Despite the legal setback, [the Washington Post reports that] opponents of the practice haven't given up the fight.

"We don't like the practice, and we want it to stop," said Jean Silver-Isenstadt, executive director of the National Physicians Alliance, a two-year-old group with 10,000 members, most of them young doctors in training. (Thakkar is on the group's board of directors.) "We think it's a contaminant to the doctor-patient relationship, and it's driving up costs."

The American Medical Association, a larger and far more established group, makes millions of dollars each year by helping data-mining companies link prescribing data to individual physicians. It does so by licensing access to the AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors.

May 23, 2007 | Permalink | Comments (0) | TrackBack (0)

Prisoners as Organ Donors

The National Law Journal has an interesting post responding to South Carolina's recent decision to encourage prison inmates to donate organs.   An earlier version of the program offered a reduced sentence as an extra incentive to donate.  Rev. Michal Orsi writes about the many ethical concerns raised by the program:

First, the National Organ Transplant Act (1984) makes it a federal crime to take or to offer valuable consideration for a transplant organ. Even without the prospect of a reduced sentence, prisoners may feel pressured to donate organs in the hopes of receiving other favors. In light of this, the proposed law may still violate federal law since it would make a body part an exchangeable commodity.

Second, ethicists have always agreed that organ donation must be freely given. This means that the donor must not be subject to any force, pressure or fear. Freedom may also be compromised because the intense hothouse culture that exists in prisons often commands conformity. Prison is not a pleasant place. Some inmates who would not ordinarily donate an organ may feel compelled to do so in order to convince a parole board of their rehabilitation.

Third, if this legislation includes live donors, it would also compromise the medical profession, whose first principle — "do no harm" — would be violated. Surgical procedures such as kidney transplant from a live donor could put a donor in physical jeopardy. The operation is risky, may have long-term consequences and may even cause death. In these cases, it would seemingly be a betrayal of a doctor's professional ethics to perform such a surgery. Needless to say, good medical ethics require that the benefit outweighs the risk. The present and future danger of live transplants would unduly risk the prisoner's health and, therefore, the proposed legislation would be substandard according to traditional medical ethics. The principle of "do no harm" is often discussed when determining the ethics of a physician being involved in prison executions by lethal injection. Most of those involved in the field of medical ethics consider this a violation of the Hippocratic Oath.

Fourth, for living donors, there are moral issues that violate the common law principle of totality. Totality forbids the mutilation of the human body that would compromise its anatomical or functional integrity. This means that any removal of a healthy body part or any decrease in bodily function caused to the donor would be deemed immoral. An exception has been made only if fraternal love is the motive for the donation. Therefore, with a donation from a living donor, common law has always presumed some kind of authentic connection between the donor and the recipient, usually kindred. An exchange between people unknown to each other imperils the concept for charity and human solidarity that have been traditionally recognized as the only clear moral grounds for the risks involved in the procedure and the violation of the principle of totality.

To put the ethical problems of the South Carolina proposal in high relief, it must be noted that even programs that require the donation of an organ to receive an organ or programs that propose offering a monetary award to donor families for donor funeral expenses are considered to be unethical. They do not conform to the federal law that is based on the common law principle that organ donation must be a totally free altruistic act.

May 23, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 22, 2007

Flu Stories

Here is some information about the new HHS Website/blog for collecting flu stories.  The weblink states,

Recognizing the need for people to take pandemic flu preparations more seriously, and recognizing that blogging is a powerful and effective two-way communications tool, Health and Human Services Secretary Mike Leavitt is hosting a Pandemic Flu Leadership Conference in Washington DC on June 13, to which I've been invited (based on work done at Flu Wiki and here). And as part of the effort to reach as many people as possible, a blog has been set up to discuss the conference's theme pre-and post-gathering.

The HHS Pandemic Flu Leadership Blog opens today for a five week run. You can access it at http://blog.pandemicflu.gov/ and read my first post today (other posters will contribute over the course of the five weeks). This week's theme is 'why we need to prep'. The five week theme is laid out at the web site.

While it won't get the traffic that this place does, think about what it represents... a government department is asking for feedback from the public on an issue that the public may have as much expertise on as the Feds, at least in some aspects of preparation. We can't keep the grid up in a natural disaster (something near and dear to bloggers everywhere), and can't coordinate responses between education departments and public health in the event of a flu pandemic (schools will need to close). That's the job of the federal government, and they need to supply the leadership to make this issue a priority at the state and local level. But we do know something about personal preparedness. So, if you have comments or questions about the blog summit, please stop by. Public health authorities are trying to reach as many segments of the population as they possibly can.

Thanks to DemFromCT for this link and information.

May 22, 2007 | Permalink | Comments (0) | TrackBack (0)

International Perspective on Obesity

Thanks to Ezra Klein for pointing out this fun graphic that illustrates the United States obesity issue. Click here.

May 22, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, May 17, 2007

FYI: New LIVESTRONG Project

Firedoglake brings to my attention this new initiative by the LiveStrong, Lance Armstrong Foundation.  Here is the information from their press release describing some of their goals:

The Gaps We Must Close

We must close the gaps between what we know and what we do in the cancer fight.

Nearly 47 million Americans lack health insurance. About 16 million more are underinsured.

Health care coverage and financial concerns should not dictate who lives, who dies and who suffers unnecessarily.

Ethnic populations in the U.S. carry a disproportionate burden of poor quality cancer care, and minorities are much more likely to die and suffer needlessly from the disease.

With screening, we could prevent 1/3 of all cancer deaths.

90% of colorectal cancer deaths, 30% of all breast cancer deaths in women over age 40 and virtually all cervical cancer deaths can be prevented now.

Cancer funding is decreasing and government attention is fragmented.

While 13 different government agencies fund cancer research, no one is in charge of the nation's cancer program. Hard to believe when 10 million people in our country are living with cancer.

We must be more efficient, more collaborative and more directed about how we use what we know.

We must close the gaps.

We must make cancer a national priority.

Today.

Here is more information about how to get involved.

May 17, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 16, 2007

HPV Update

Yesterday's Science Times ran an article discussing the benefits of the HPV vaccine.  It states some of the benefits as follows:

¶That infections with human papillomavirus, or HPV, are the most common sexually transmitted diseases?

¶That there is no treatment for HPV infections?

¶That cervical cancer is the most serious sexually transmitted disease caused by this virus?

¶That 70 percent of cases of cervical cancer arise because of two variants of the virus that the new vaccine protects against?

¶ That 90 percent of genital warts cases are caused by two other variants of the virus that are countered by the vaccine?

¶That most people infected with HPV do not know it, yet can transmit the virus to an unsuspecting sexual partner?

¶That 20 percent of American girls 14 to 19 are infected, and the vaccine works only if administered before women contract the viral variants it is intended to prevent?

The article also raised the equity issue, about which I had been wondering (I mean, really, why only girls?).  It states,

In the name of equality, some advocates urge that boys, too, be immunized, because they spread the infection to women. In fact, men may benefit directly from the vaccine, because the virus can also cause cancers of the penis and anus. Anal cancer is a particular concern to gay men, and a study is under way to determine whether the new vaccine will protect gay men from cancer.

Last week, the New York Times ran an article discussing different ways that states are encouraging individuals to get the vaccine.  The article discusses how successful New Hampshire has been with its program of making the vaccine voluntary, as well as giving it free to girls and young women ages 11-18.  New Hampshire has not suffered the backlash that other states, which mandated the vaccine, have seen. 

May 16, 2007 | Permalink | Comments (0) | TrackBack (0)

The Poetry of the Annual Physical

From this week's JAMA, some poetry to go with your annual physical:

 

John Grey
Providence, RI

Mine are never quite that poetic . . . .

May 16, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 15, 2007

Artificial Reproductive Technologies

The Diane Rehm show had an interesting discussion of the use of artificial reproductive technologies today: 

Helping people who otherwise might never have had children become parents is becoming a big business in the U.S. But advances in reproductive technology - from in vitro fertilization to egg and sperm donation and surrogacy - are also raising ethical and societal issues. A look at how science is helping those who otherwise might never have had their own genetic children... and the questions it is raising for parents, partners and society.

Guests

Dr. Kathy Hudson, founder of the Pew-funded Genetics and Public Policy Center at Johns Hopkins University.

Dr. Robert Stillman, Medical Director of Shady Grove Fertility Center, in Washington, DC and Baltimore.

Liza Mundy, a feature writer at "The Washington Post Magazine."

The show did not discuss too much some of the prenatal genetic testing that co-exists with some of these technologies but the New York Times has recently run some interesting articles and letters to the editor (here, here and here) discussing the impact of prenatal testing on disabled individuals, and their relatives, and whether such testing and how people respond to such testing should be more heavily regulated.

May 15, 2007 | Permalink | Comments (0) | TrackBack (0)

Getting What You Pay For?

A new report demonstrates that Americans pay the most for their health care yet receive the poorest level of care.  MSNBC discusses the report by the Commonwealth Fund (great website with lots of helpful data) and states,

Americans get the poorest health care and yet pay the most compared to five other rich countries, according to a report released on Tuesday.

Germany, Britain, Australia, New Zealand and Canada all provide better care for less money, the Commonwealth Fund report found.

“The U.S. health care system ranks last compared with five other nations on measures of quality, access, efficiency, equity, and outcomes,” the non-profit group, which studies health care issues, said in a statement. . . . .

“The United States is not getting value for the money that is spent on health care,” Commonwealth Fund president Karen Davis said in a telephone interview.

The group has consistently found that the United States, the only one of the six nations that does not provide universal health care, scores more poorly than the others on many measures of health care.

Congress, President George W. Bush, many employers and insurers have all agreed in recent months to overhaul the U.S. health care system — an uncoordinated conglomeration of employer-funded care, private health insurance and government programs.

The current system leaves about 45 million people with no insurance at all, according to U.S. government estimates from 2005, and many studies have shown most of these people do not receive preventive services that not only keep them healthier, but reduce long-term costs.

Davis said the fund’s researchers looked at hard data for the report.

“It is pretty indisputable that we spend twice what other countries spend on average,” she said.

Per-capita health spending in the United States in 2004 was $6,102, twice that of Germany, which spent $3,005. Canada spent $3,165, New Zealand $2,083 and Australia $2,876, while Britain spent $2,546 per person.

May 15, 2007 | Permalink | Comments (0) | TrackBack (0)

Monday, May 14, 2007

Medicine in War on Terror Prisons

U.S. Military Medicine in War on Terror Prisons

From the press release:

"The University of Minnesota’s Center for Bioethics and Human Rights Center have created a comprehensive archive of government documents describing medical operations in U.S. prisoner of war facilities in Iraq, Afghanistan and Guantanamo Bay, Cuba. The archive, now launched, can be accessed from the home page of the Human Rights Library (http://www.umn.edu/humanrts) or directly at www1.umn.edu/humanrts/OathBetrayed/index.html

The archive’s purpose is to enable scholars, journalists, policymakers and interested citizens to study and understand the medical operations in these prisons. It contains more than 60,000 pages of indexed White House and Defense Department policies, prison medical records, autopsy reports, criminal investigations, sworn witness statements and e-mails involving the Armed Forces and the FBI." 

Thanks to Ron Jones and Jim Hart for this website information.

May 14, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 9, 2007

Update on "Pillow Angel" Surgery

Some of you may remember the surgery performed on Ashley at the request of her parentsCNN reports that the hospital alllegedly violated Washington state law by failing to obtain a court order before performing a hysterectomy.  It looks to me like the parent's attorney may have to explain how he/she reached the conclusion that a court order was unnecessary.   According to CNN:

A hospital that performed a controversial procedure that stunted the growth and sexual development of a profoundly disabled child violated Washington state law by sterilizing her, according to an investigative report released Tuesday. The case has raised medical ethics questions and rankled disability and feminist groups.

The Washington Protection and Advocacy System, a private group vested with federal investigative authority for people with disabilities, found that Seattle Children's Hospital and Regional Medical Center violated the constitutional and common law rights of a girl identified only as Ashley by performing a hysterectomy without a court order from the state.   "Washington law specifically prohibits the sterilization of minors with developmental disabilities without zealous advocacy on their behalf and court approval," said Mark Stroh, WPAS executive director, in a statement.

Children's Hospital, in acknowledging its error, said that beyond implementing changes to ensure that sterilization of disabled children doesn't happen again without a court order, it will seek court approval for other procedures involved in the controversial growth attenuation therapy.  "We deeply regret that a court order was not obtained," Dr. David Fisher, medical director at Children's Hospital said in a statement. "The parents consulted an attorney and obtained a legal opinion that concluded the treatment was permissible under Washington state law without the need for a court order. This is where our system broke down. We take full responsibility."

Ashley, 9, has a condition called static encephalopathy, which means an unchanging brain injury of unknown origin.  "It was like seeing a baby in a much larger body," said Dr. Douglas Diekema, director of education at Treuman Katz Center for Pediatric Bioethics in Seattle and chairman of the bioethics committee of the American Academy of Pediatrics, who was brought in to consult on this case. "She would never talk, never walk, and was dependent on her parents to meet all her needs. Her cognitive function was the equivalent of that of an infant, unlikely to ever change." Family members call her their "pillow angel." . . . .

In 2004, when Ashley was 6, her uterus and breast buds were removed, and she received a high-dose estrogen therapy. As a result, Ashley was frozen as a child. She attained her full growth at 4 feet 5 inches and 75 pounds, with no reproductive capacity.  Ashley's parents say that compassion, not convenience of care, was their motive.

Writing on their blog, her parents said, "Ashley's smaller and lighter size makes it more possible to include her in the typical family life and activities that provide her with needed comfort, closeness, security and love: meal time, car trips, touch, snuggles, etc." . . . .

The parents, in an updated entry on their blog Tuesday, reiterated that "given Ashley's developmental state and prognosis ... voluntary procreation was not applicable to her case and will never be."  "Sterilization is not the intent of the 'Ashley Treatment,' but a byproduct of it," they wrote, adding that while they support laws protecting against involuntary sterilization, they believe the law is "too broadly based" to "distinguish between people who are or can become capable of decision-making and those who have a grave and unchanging medical condition such as Ashley."

Diekema told CNN the ethics committee recognized that Washington state law was not perfectly clear with regard to whether a court order would be necessary to do the hysterectomy in someone who could not consent to the procedure.

One nationally known ethicist said he believes the hospital erred.  "I absolutely agree this procedure should have been reviewed by a court," said medical bioethicist Arthur Caplan. "There was not enough due process to look out for the young girl's rights, so I think that was a severe failure in deciding to do this procedure."

For some other views about the surgery, click here.

May 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Interesting Research Proposal Information

Michelle Mello and David Studdert of the Harvard School of Public Health and the University of Melbourne have made information about their work on a proposal for policy experiments with administrative compensation for medical injury ("health courts") available online at http://www.hsph.harvard.edu/faculty/michelle-mello/current-projects/
Additionally, the project is being featured this week on the blog of the Portfolio of the Robert Wood Johnson Foundation, Pioneering Ideas (http://blogs.rwjf.org/). They will be publishing several posts about our research, and the blog will also feature posts by their partner in this effort, Paul Barringer of Common Good, as well as commentary by the Foundation.  Comments are welcome.
You can also read about other current projects of Law and Public Health researchers at Harvard at http://www.hsph.harvard.edu/faculty/michelle-mello/current-projects/ and http://www.hsph.harvard.edu/faculty/michelle-mello/recent-research-highlights/.
You can ask to be included on announcements of forthcoming research papers using the email form at http://www.hsph.harvard.edu/faculty/michelle-mello/contact-us.html

May 9, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 8, 2007

FDA: Food and Drug Contamination

The New York Times on Sunday ran an article discussing how some imported drugs contain a poison syrup, diethlene glyclol (normally found in antifreeze) rather than glycerin, a more expensive syrup, which is safe to use in a variety of pharmeutical products. 

Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste and other products.

Toxic syrup has figured in at least eight mass poisonings around the world in the past two decades. Researchers estimate that thousands have died. In many cases, the precise origin of the poison has never been determined. But records and interviews show that in three of the last four cases it was made in China, a major source of counterfeit drugs. . . . .

Last week, the United States Food and Drug Administration warned drug makers and suppliers in the United States “to be especially vigilant” in watching for diethylene glycol. The warning did not specifically mention China, and it said there was “no reason to believe” that glycerin in this country was tainted. Even so, the agency asked that all glycerin shipments be tested for diethylene glycol, and said it was “exploring how supplies of glycerin become contaminated.”

China is already being accused by United States authorities of exporting wheat gluten containing an industrial chemical, melamine, that ended up in pet food and livestock feed. The F.D.A. recently banned imports of Chinese-made wheat gluten after it was linked to pet deaths in the United States.

Beyond Panama and China, toxic syrup has caused mass poisonings in Haiti, Bangladesh, Argentina, Nigeria and twice in India.

Today, the Diane Rehm show explores further some of the FDA's recent lapses in safety - particularly with regard to the melamine found in chickens as well as other parts of the U.S. food supply.  Perhaps we need to re-consider our priorities when spending money on protecting the public - the FDA should not be relying on industry standards to prevent these terrible events.

May 8, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 1, 2007

Free Drug Samples: Not so Healthy

Well, those who say the best things in life are free . . .they could be wrong when it comes to free drug samples.  The New York Times reports today,

Patients like going home with free samples because it saves them a trip to the drugstore and a co-pay, and doctors are happy to oblige, because samples help patients get started on treatment right away.

But now some leading academic medical centers are restricting the use of samples, and a smattering of physician practices are shutting down the sample cabinet. These critics say doctors should be choosing the most appropriate medication for a patient based on the best scientific evidence available — not just grabbing something from the office stash that happens to fit the bill.

“The doctor will say, ‘Here, start on this, and let’s see how it works,’ ” said David J. Rothman, president of the Institute on Medicine as a Profession, a research group at Columbia. “The question to the doctor is: If you didn’t have it in your drawer, would that have been your drug of choice?”

The crackdown on free samples comes amid growing concern about the close ties between physicians and drug companies. Critics like Dr. Rothman say physicians don’t realize the extent to which their medical judgment is influenced by their acceptance of the samples. They point to studies like a 2002 paper in the journal Annals of Family Medicine finding that the number of doctors who treated high blood pressure with the “first line” drugs recommended by national guidelines was low, but increased sharply when free samples were removed. . . . .

But there’s an upside to the samples. Using samples, a doctor can see if a patient can tolerate a new medication before the patient goes out and buys a 30-day supply. Physicians who treat poor people like to have samples on hand for them, and for uninsured patients.

Samples also provide patients with the convenience of one-stop shopping, said Dr. Hema A. Sundaram, a dermatologist in suburban Washington. “Usually a patient has waited some time to see a doctor and rearranged their whole working schedule, and then it may be another four or five days before they can fill a prescription,” she said. “They’re often busy, working people, with family responsibilities. I feel there shouldn’t be any further delay.” (Dr. Sundaram acknowledges that she is paid for speaking on behalf of drug companies.)

And many physicians say they like using samples because the sales representatives are an important source of medical education, helping to keep the doctors up to date on the latest therapies.

As for the bottom line, it’s not at all clear that samples save patients money. Critics say they may actually drive up the cost of health care in the long run, because the drugs being promoted are the most expensive brand-name medications. Since many conditions require lifelong treatment, the patient would have to buy the medicine sooner or later.

“You’re going to be paying more, because you’re taking the new, advanced drug,” Dr. Rothman said. “And you may have done just fine on the old-fashioned generic.”

May 1, 2007 | Permalink | Comments (0) | TrackBack (0)

More From the FDA

The blog, Lilbrit, has some more news about the FDA's recent handling of the melaimine that somehow got into lots of food in the United States.  She refers us to a new FDA Alert found on the FDA website, and explains how broad it truly is:

IA #99-29, 4/27/07,  IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

[...]

PRODUCTS: Wheat Gluten
   Rice Gluten
   Rice Protein
   Rice Protein Concentrate
   Corn Gluten
   Corn Gluten Meal
   Corn By-Products
   Soy Protein
   Soy Gluten
   Proteins (includes amino acids and protein hydrosylates)
   Mung Bean Protein

PROBLEM: Poisonous or Deleterious Substance Unfit For Food
   Unsafe Food Additive

PAF:          PES

COUNTRY:      China (CN)

MANUFACTURER/SHIPPER:     All

CHARGES:   "The article is subject to refusal of admission pursuant to
     section 801(a)(3) in that it appears to bear or contain a
     poisonous or deleterious substance, which may render it
     injurious to health [Adulteration, section 402(a)(1)]"

Lilbrit:  Look at that list now--it includes just about every form of grain protein there is. Soy, rice and mung bean proteins that go into cookies and pizza dough and baby food, as well as countless "healthy" smoothies served at juice bars across the country. Would you like a sprinkle of melamine  splash of cyanuric acid shot of protein powder in your mango shake for just a dollar more?

This summer I had decided to grow some herbs in pots in backyard - perhaps it is time to consider an expansion of that idea.

May 1, 2007 | Permalink | Comments (0) | TrackBack (0)