Beware FDA Changes to Guidelines

Change in FDA's ethical guidelines for clinical trials troubling: Lancet

The Lancet medical journal is reporting that the United States Food and Drug Administration is abandoning the Declaration of Helsinki as an ethical foundation for international clinical trials.

The declaration was drafted in 1964 by the World Medical Association to provide binding ethical standards for medical research involving humans.

Many basic patients' rights are enshrined in the declaration. Sections of it also govern business and environmental practices of the researchers.

The FDA is instead adopting the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP), which allows less stringent ethical standards for overseas research.

In a commentary published in the Jan. 3 issue of the Lancet, medical research experts Jonathan Kimmelman of McGill University, Charles Weijer of the University of Western Ontario and Eric Meslin of the University of Indiana call the move "troubling."

The authors urge the incoming U.S. administration of president-elect Barack Obama to stick to the original declaration pending a review of the implications for American research overseas should the new guidelines be adopted.

"The FDA regulates the largest drug market in the world, and we worry that its replacement of the Declaration of Helsinki with a less morally authoritative document may cause others to follow suit, thereby undermining international ethical standards for research," they write.

In October 2008, the FDA formally stopped requiring that foreign clinical studies supporting applications for drug licensing comply with the declaration.

The authors point out several important requirements that the declaration contains but the GCP lacks, including:

* Investigators must disclose funding, sponsors and other potential conflicts of interest to both research ethics committees and study participants.
* Study design must be disclosed publicly (e.g., in clinical trial registries).
* Research, notably that in developing countries, must benefit and be responsive to health needs of populations in which it is done.

Source:CBC.ca

Pharma Execs Guilty of Misleading Public

The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug's risk of addiction, a federal prosecutor and the company said.

Purdue Pharma LP, its president, top lawyer and former chief medical officer will pay US$634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said.

The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.

"With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."

Privately held Purdue learned from focus groups with physicians in 1995 that doctors were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.

Ken Jost of the Justice Department's Office of Consumer Litigation said this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit.

"The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors," Jost said. "We have the people, we have the resources. We'll take the time and we'll take the effort to find out what they did and how they did it."

Purdue Pharma said it accepted responsibility for its employees' actions.

"During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again," the company said in a news release.

OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.

From 1996 to 2001, the number of oxycodone-related deaths nationwide increased fivefold while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.

The U.S. attorney said the guilty pleas were entered Thursday morning in U.S. District Court in Abingdon, southwest of Roanoke. In an unusual move, Brownlee said, company chief executive officer Michael Friedman, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanour count of misbranding the drug. Of the total fine, $34.5 million was levied on those three.

The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement.

When he took office in 2001, Brownlee said, his office was handling a number of cases related to OxyContin abuse, including crimes by addicts seeking to support their habits and arrests of street dealers and even pharmacists and physicians.

"But it always seemed, I think to me and to the investigators, that there was more," he told a news conference.

Investigators from a number of state and federal agencies worked together on an investigation of Purdue Pharma and began to subpoena company records in 2002, Brownlee said.

"From these millions of records, they picked out probably 300 to 500 documents and pieced together a case," he said.

The Food and Drug Administration was part of the investigation. A spokesman for Connecticut Attorney General Richard Blumenthal said the agency had not acted on a citizen petition Blumenthal's office filed more than three years ago. The petition raised concerns about misbranding and called for stronger warnings and fuller disclosure about OxyContin's dangers.

Kim Rice of the FDA told the news conference that over time the agency has mandated increasingly stronger warnings on labels about OxyContin's abuse potential.

Source: CBC.ca

Ontario Medical Transparency

For the first time, Ontario patients will be able to easily discover if a doctor has been found guilty of medical malpractice, has a criminal conviction and why or what limits have been put on a physician's licence.

Public light will be shone not only on the records of doctors, but those of all regulated health professionals – from nurses to dentists to acupuncturists. All will now be required to report findings against them to their respective professional colleges. And those colleges must release the information to the public. As well, findings against medical professionals will no longer be wiped clean after six years. These changes are all amendments to legislation moving through the Ontario Legislature to improve hospital safety.

In addition, all Ontario hospitals will be required to report safety information such as medical errors – what hospitals call adverse events – to the province, which will make it public on websites. These changes to existing provincial legislation will ensure that secrecy will end.

The changes will put Ontario at the forefront of medical transparency in Canada.

Health ministry officials say the move comes in response to a Toronto Star series on medical secrecy that began last October. The series highlighted the absence of safety information available to patients once they step inside Ontario's hospitals. For instance, patients have no idea how many cases of hospital-borne infections have swept through a hospital or how many have died after a specific surgical procedure.

The Star has pursued the issue of medical secrecy since 1997.

This is all part of improving quality of care, said Health Minister George Smitherman. "If you measure things, you hold yourself to a test," the minister told the Star yesterday. "This is, accordingly, a big step forward. But it's not just about me saying this and you recording it in your newspaper. It is a really complicated and challenging step. We'll have to work really hard with a lot of different players to make it work well."

Those partners are the Ontario Hospital Association, the Ontario Medical Association and all the regulated colleges such as the College of Physicians and Surgeons of Ontario.

"We've had several discussions with government over the last several weeks," said Patrick Nelson, a spokesperson for the OMA, the professional group representing 24,000 doctors.

Nelson said it was important to the OMA that health professionals maintain their right to a fair hearing – they believe doctors' rights would be denied if complaints were publicly posted without due process. "We needed to make sure that action only be taken on transparency if a health professional has been found guilty of misconduct. It's not fair to take action before a hearing or finding."

The changes do not go as far as releasing complication rates of individual doctors or surgeons.

The Star series exposed the plight of women who claim they were victims of medical negligence at the hands of a Scarborough obstetrician and gynecologist. The former patients of Dr. Richard Austin held a press conference on April 19, calling on the province to lift the veil of secrecy over doctors' complication rates, malpractice suits and complaints. More than 50 women have now contacted the Star to allege they were victims of medical errors by Austin. The series revealed a pattern of lawsuits, complication rates and unintended cuts to internal organs by Austin that medical experts call well above average.

At least 15 of the women have filed lawsuits since 1983. In one case, a judge ruled Austin guilty of battery against a patient. Four are before the courts. Six suits were settled out of court, four were dropped, including three in which complainants cited high legal costs as part of the decision to abandon their cases.

Austin and his lawyers have not answered repeated requests for an interview.

Frances Borrow was one of the women at the press conference. She has been living with a plastic bag strapped to her stomach to collect her urine ever since her bladder was accidentally cut during a hysterectomy in 1990. "I'm very pleased to hear this. It would've changed my decision if I'd known that kind of information when I had surgery." Toronto lawyer Amani Oakley is acting on behalf of many of the women. She called the proposed and mandatory changes an amazing first step. "It's an excellent step toward transparency. But it doesn't make sense to stop at the edge. Individual (physician) complication rates are key," she said. "You can still see cases like Austin that would be a problem. We have two rights bumping up against each other – the right of the physician to hide poor complication rates versus the right of patients to know if bad complication rights exist. In this case, it seems overwhelmingly obvious that the public would favour the right of the patient to know."

Settlements made after a claim of medical malpractice is made will not be part of the changes.

Smitherman has maintained he's not sure how best to capture and report complication rates – by health team or specific doctor or nurse. "We have a lot of work to do with our partners."

Some of Ontario's highest-ranking medical officials have been calling for greater transparency. Three weeks ago, Dr. Alan Hudson, head of the Ontario Wait Times Strategy and former president of the University Health Network, announced hospital funding would be tied to disclosure of quality and safety information.

"If you are going to buy a house in Ontario, you check the roof, you check the wiring and plumbing. This is slightly more important," said Hudson. "This is your life."

Dr. Michael Baker, UHN Physician-in-Chief who advises the Ministry of Health on patient safety, said: "Analyzing mortality rates and infections and other issues lead us to analyze what we can do better. The American evidence does suggest that it leads to improvements in safety. We can't look bad if we disclose. We can only look good for sharing what we have."

As many as 23,750 people die each year from in-hospital adverse events, according to the Canadian Institute for Health Information, more than the number who die from breast cancer, car accidents and HIV combined.

The OMA said most adverse events in hospitals are not the fault of one person. "We know the majority of adverse events in hospitals are the result of systemic problems, not the result of an individual," said Nelson. "For this reason, we've maintained that improved patient outcomes require a systemic team-based approach."

Source: Toronto Star

Rating Doctors

Doctor rating website stirs up physicians

The Canadian Medical Association and the Canadian Medical Protective Association have asked a U.S.-based website that allows patients to post anonymous comments about physicians to remove ones they believe are defamatory.

Canadian users of RateMDs.com could potentially be sued for libel, the associations warned, and they have asked for names of people and IP addresses that identify computer users making comments.

San Jose, Calif., native John Swapceinski, who founded the website and runs it, has refused, saying he won't give user information without a court order.

Conditions in Canada's sometimes struggling health-care system may be contributing to the popularity of the website. About one-third of the doctors listed on RateMDs.com are Canadian, as are about two-thirds of the visitors to the site.

Swapceinski acknowledged at least one doctor's office made multiple, glowing postings in an effort to boost ratings.

The site tries to screen offensive comments and prevent more than one posting from a computer

Outlet for frustrated patients

Comments on the website range from deserved criticism of poor people skills, to unfair, unfounded gossip.

Dr. Lynne Harrigan is a specialist in internal medicine and chief of staff at the Valley Regional Hospital in Kentville, N.S.

Of the 19 postings about Harrigan on the website, eight are negative, complaining she made them feel rushed or she lacks compassion.

Although the other postings are full of praise, Harrigan said the resulting overall rating of "average" is devastating.

"The terrible insecurity I feel with having that out there when it's not true, and I have no way to defend myself," said Harrigan. "So to me it's an example of how terrible the internet can be, and how damaging."

Strained system

Stressed doctors can sometimes be brusque, and the site has tapped into patients' feelings of helplessness and frustration at trying to navigate an overburdened health-care system, where there is pressure and waiting lists to see doctors, said writer Brad Mackay of Ottawa.

Mackay examined the website and its impact in Tuesday's issue of the Canadian Medical Association Journal.

"Poor bedside manner is just part and parcel of a strained health-care system," said Mackay. "Right or wrong, this just shows it."

There is no way to tell if the information is reliable or valid, said Dr. Ajantha Jayabarathan, a family physician in Halifax, who received mostly positive ratings on the site.

If a patient posts a concern, there is no way to bring it to the attention of a physician.

"There is no opportunity for remedy," said Rhonda Church of Doctors Nova Scotia.

Source: CBC.ca