Tom Lamb at drugwatch.com says FDA has cancelled plans that they announced in 2005 to establish a new web site, to be called Drug Watch, that would alert doctors and patients about emerging drug safety issues. “One could think of it as the FDA’s early-warning system for serious side effects that might be linked to FDA-approved prescription drugs,” Lamb says.
This new Drug Watch web site, Lamb says, was supposed to be “a key part of the FDA’s effort to improve its performance in fulfilling its drug safety monitoring role, which was roundly criticized following the September 2004 Vioxx recall.”
(full story…)

People, families and medical caregivers want improvements for those who die in hospital intensive care. In an era of increasing trust in use of home hospice many people say that they would prefer to die at home, or in a homelike setting. But a considerable number of patients with chronic, life-threatening illnesses enter hospital for acute care near the end of life and die in an intensive care unit (ICU).

Today 1 in 5 deaths in the United States takes place in the intensive care unit (ICU) or shortly after receiving intensive care, a trend that is likely to continue, according to intensive care specialists writing in a supplement to this month’s Critical Care Medicine.

More patients with severe illness are arriving at ICUs, the authors explain, and many families and patients with chronic, life-limiting diseases are opting for a trial period of intensive care. The patients have needs which traditional ICUs were not specifically designed to meet, especially needs for ongoing palliative or “comfort care.” And the families need and are asking for more information and support.

Full story:
http://www.psa-rising.com/living/end-of-life-care2-06.html

Are patients’ medical privacy concerns best served by the opt-out or the opt-in privacy systems? In British Medical Journal July 1, 2006 this is debated from a UK and a US perspective:

For and against:
Patients should have to opt out of national electronic care records

“. . . issues of consent and security are dividing health professionals, the public, and the national programme for information technology. Nigel Watson believes his experience of opting out shows it to be the most workable option, but John Halamka uses a US model to argue that opting in is the only way to ensure confidentiality.”
http://press.psprings.co.uk/bmj/july/ac39.pdf

BMJ.com this week

02 June, 2006
Associated Press
Doctors Say Futile Cancer Treatment Rising
By MARILYNN MARCHIONE , 06.02.2006, 07:35 PM

Doctors are reporting a disturbing rise in the number of cancer patients getting chemo and other aggressive but futile treatment in the last days of their lives.

Critics of the practice say doctors should be concentrating instead on helping these patients die with dignity and in comfort, perhaps in a hospice.

Nearly 12 percent of cancer patients who died in 1999 received chemotherapy in the last two weeks of life, a large review of Medicare records revealed. That is up from nearly 10 percent in 1993, and the percentage probably is even higher today, researchers said.

“Patients don’t like to give up,” and neither do physicians, said Dr. Roy Herbst, a cancer specialist at the University of Texas’ M.D. Anderson Cancer Center in Houston who had no role in the study.

Overly aggressive treatment gives false hope and puts people through grueling and costly ordeals when there is no chance of a cure, cancer specialists said.

“There is a time to stop,” said Dr. Craig Earle of the Dana-Farber Cancer Institute and Harvard Medical School. “It’s sometimes easier to just keep giving chemotherapy than to have a frank discussion about hospice and palliative care.”

Earle led the federally funded study and presented the findings Friday at a meeting in Atlanta of the American Society of Clinical Oncology. . . . .

However, another study presented at the cancer meeting on Friday showed the opposite problem: people not getting enough care.

A survey of nearly 700 primary care doctors in Wisconsin found that only 11 percent would refer a patient with advanced lung cancer to a cancer specialist and only 25 percent would refer a woman with advanced breast cancer.

“We also found a general lack of knowledge about the benefits of newer treatments” that can help such patients, said Dr. Timothy Wassenaar of the University of Wisconsin-Madison, who reported on the study at the cancer meeting.

“That’s horrible,” Herbst said of the unwillingness to refer such patients. He noted that newer chemotherapy treatments have extended lung cancer survival from 20 percent at one year to nearly 50 percent now.

Full story:
Doctors Say Futile Cancer Treatment Rising — Forbes.com

12:35 May 15, ‘06 / 17 Iyar 5766

(IsraelNN.com) Colon cancer patients launched a hunger strike “to the death” outside the Knesset on Sunday, announcing that if the national government does not update the healthcare basket to include their drugs, they will continue their strike until their death, explaining they have nothing to lose.

Strikers explain that the healthcare system does not currently subsidize the drugs that can save their lives, and therefore, the pharmaceuticals are too expensive for them. They insist the government cannot turn their backs on so many citizens who can be helped, but lack the funds to purchase the drugs that offer them a cure.
Source:
Arutz Sheva - Israel National News

Wary of Backlash, Cancer-Drug Makers Weigh Price Limits
Wall Street Journal
By JOHN CARREYROU and GEETA ANAND
May 10, 2006; Page B1
As high prices of cancer drugs spark the kind of patient outrage that high AIDS-drug prices unleashed more than a decade ago, a few pharmaceutical and biotech companies are weighing caps and other cost-containment measures, before the outcry turns into a public-relations crisis for the industry.

ImClone Systems Inc. and Bristol-Myers Squibb Co., co-marketers of Erbitux, one of the most expensive cancer drugs on the market, are “well down the road” toward establishing an annual patient price cap for the drug if its market expands, says Ronald Martell, senior vice president of commercial operations at ImClone. Such a program would set an annual ceiling on individual patients’ drug-treatment costs, beyond which companies would provide the drug free of charge or at a steep discount. Genentech Corp., of South San Francisco, Calif., is considering cost-containing alternatives for Avastin, which is currently approved for treatment of early-stage colorectal cancer.
While the backlash against cancer-drug prices is nowhere near as big as the one against AIDS-drug prices, ImClone’s Mr. Martell says the industry should make changes in its policies now. “Otherwise, at some point there will be a confluence of events — social pressure, volume of dollars — and something will have to give,” he warns.

Erbitux, priced at $10,000 a month, is currently approved only for patients with metastatic colorectal cancer who have failed a certain kind of chemotherapy. Their average total cost of treatment is currently about $40,000: In most of these patients, the illness has advanced to the point where they are only a few months from death.

But later this year, ImClone and Bristol-Myers, both based in New York, hope to win Food and Drug Administration approval to market Erbitux for patients in earlier stages of colorectal cancer, who have longer life expectancies. Approval for these patients would result in a sharp rise in the average cost of treatment with Erbitux — and a sharp rise in profits.

In the case of Genentech’s Avastin, the current cost of treatment — $4,400 a month, or $52,000 a year — could rise sharply if the FDA approves the drug as a treatment — at double the dose — to treat lung cancer and breast cancer. Such approvals, expected over the next year, could result in thousands of new patients paying, at current prices, more than $100,000 a year to take Avastin.

The Medicare Modernization Act of 2003, which extended prescription-drug benefits to the elderly, has put financial pressure on elderly cancer patients, the age group with the highest rates of the disease. Under the old system, cancer patients receiving drugs intravenously at a hospital in practice often weren’t forced to make their 20% co-payment: The hospital would bill Medicare directly, and the Medicare reimbursement price — as much as 25% above the drugs’ market price — provided a sufficient profit cushion so that hospitals often didn’t collect co-payments.

But now, Medicare reimbursements are in line with drugs’ actual selling prices, and physicians and hospitals can no longer afford to forgive co-payments. As a result, many elderly cancer patients without supplemental prescription-drug insurance end up on the hook for thousands of dollars.

“There’s a groundswell of patients who are outraged,” says Jerry Flanagan, health-care policy director for the Foundation for Taxpayer & Consumer Rights, a Los Angeles watchdog group.

Full story at Wall Street Journal: Wary of Backlash, Cancer-Drug Makers Weigh Price Limits
By JOHN CARREYROU and GEETA ANAND
May 10, 2006; Page B1 May require subscription or initial ad view.

The West Australian: Poor kept in dark on cancer treatments

DAWN GIBSON

One in three medical specialists would not tell a cancer patient about a new drug that could prolong their life or improve their last days if the doctors thought the cost was well beyond the patient’s means.

Startling new medical research has highlighted how Australia has developed a two-tier system for cancer treatment - one for the rich and another for everyone else - because new-generation, life-prolonging drugs that cost up to $60,000 a year are not available under the Pharmaceutical Benefits Scheme.

A national survey of almost 200 medical oncologists found some doctors were reluctant to tell patients about unsubsidised drugs if they thought they could not afford them.
(full story…)

Today’s New York Times is running a story by Alex Berenson in the business section about Genentech’s Avastin, A Cancer Drug Shows Promise, at a Price That Many Can’t Pay. “Doctors are excited about the prospect of Avastin, ” Berenson writes, “a drug already widely used for colon cancer, as a crucial new treatment for breast and lung cancer, too. But doctors are cringing at the price the maker, Genentech, plans to charge for it: about $100,000 a year.”
(full story…)

Supreme Court Upholds Oregon Suicide Law
Brocktown News, Nevada
17 January, 2006
By GINA HOLLAND

WASHINGTON - The Supreme Court, with Chief Justice John Roberts dissenting, upheld Oregon‘s one-of-a-kind physician-assisted suicide law Tuesday, rejecting a Bush administration attempt to punish doctors who help terminally ill patients die.

That means the administration improperly tried to use a federal drug law to prosecute Oregon doctors who prescribe overdoses. Then-Attorney General John Ashcroft vowed to do that in 2001, saying that doctor-assisted suicide is not a “legitimate medical purpose.”

Justice Anthony Kennedy , writing for the majority, said the federal government does, indeed, have the authority to go after drug dealers and pass rules for health and safety.

Tuesday‘s decision is a reprimand of sorts for Ashcroft. Kennedy said the “authority claimed by the attorney general is both beyond his expertise and incongruous with the statutory purposes and design.”

“The authority desired by the government is inconsistent with the design of the statute in other fundamental respects. The attorney general does not have the sole delegated authority under the (law),” Kennedy wrote for himself, retiring Justice Sandra Day O‘Connor Sandra Day O‘Connor and Justices John Paul Stevens , David Souter , and Ruth Bader Ginsburg , and Stephen Breyer .

Roberts and Justices Clarence Thomas and Antonin Scalia dissented.

“If the term

legitimate medical purpose‘ has any meaning, it surely excludes the prescription of drugs to produce death,” he wrote.

Ashcroft had brought the case to the Supreme Court on the day his resignation was announced by the White House in 2004. The Justice Department has continued the case, under the leadership of his successor, Attorney General Alberto Gonzales.

More reports:
(full story…)

Follow up to the Oslo fabrication. Dr. Sudbø is not in hiding, but he is “on sick leave” and cannot be reached. His wife and his twin brother, who are both scientists, worked with him on the The Lancet study, according to the Guardian, but were unaware of his fraud.

No way of knowing as yet if any statements about the effect of NSAIDs on oral cancer in his article are true. It’s plain though that Dr. Sudbø assembled no genuine evidence for anything that he claimed in this study. He created a simulated reality, a database of pretend patients.
(full story…)

Last April PSA Rising ran a brief report of a Norwegian study that claimed that “Non-steroidal anti-inflammatory drugs (NSAIDs) prevent some cancers but . . . the advantage from NSAID protection against oral cancer was wiped out by double the rate of heart attack or stroke.”

This weekend it was evident that this study of the effects of ibuprofen and naproxen on oral cancer was fabricated from A to Z.

Norwegian hospital officials stated last week that the study was faked. Today, according to Reuters, the hospital in Oslo said: “A Norwegian cancer expert made up fictitious patients for an article about treatment of oral cancer published in a leading medical journal. . . .”

“The material was fabricated,” said Trine Lind, spokeswoman of the Norwegian Radium Hospital where Jon Sudbo has worked as a doctor and a researcher. “We are shocked. This is the worst thing that could happen in a research institution like ours.”

The hospital spokeswoman said Sudbo, 44, “invented patients and case histories for a study of oral cancer that was published in the British medical journal the Lancet in October 2005.”

The Lancet is Britain’s leading medical journal.

ANNE MARTE BLINDHEIM in the Norwegian daily Dagbladet reported Friday Frykter norsk lege har jukset før that “250 of his sample of 908 people in the study all shared the same birthday,” Reuters said.

Stein Vaaler [photographed below], strategy director for the Oslo cancer center, said: “A colleague raised questions about the article when it was published,” and (according to reports by Canadian CTV and Associated Press ( Cancer researcher admits to fabricating data) “when the researcher was confronted this week about the data, he acknowledged the fabrication, Vaaler said.”

Norwegian media are calling the situation “a personal tragedy.”

“All of it was fabricated,” Vaaler said. “It was not manipulation of real data — it was just complete fabrication.”
(full story…)

In a recent letter to Cancer Investigation, David Steinberg, a hematologist at Lahey Clinic, Burlington, Mass, wrote:

“A $1,000 lottery ticket for a Porsche Boxster automobile was offered to the investigator who accrued the most patients to a Southwest Oncology Group prostate cancer protocol.”

“This was done” Dr. Steinberg says,” with the admirable intention of increasing patient accrual and improving the outlook for men with high risk prostate cancer.”

From the point of view of the patients pulled in as “bodies” for this trial, a skeptic might say, the intention was not necessarily admirable. How is a doctor going to give a patient a fair and unbiased evaluation of whether a trial is good for that indivual to enter when a Porsche beckons - And the patient doesn’t know about this? At the very least, the doctors should have been obliged to disclose their chance of winning the Porsche among other information required for the patient’s informed consent.

The Boxster is the fastest selling Porsche in history with a base price of $42,000, nicely loaded for $9,000 more.

Kudos to Dr. Steinberg for protesting this sleaze.
(full story…)