Wednesday, September 12, 2007

BLOGSCAN - Seeking to Punish Health Care Leaders

On PharmaLot, Ed Silverman reports on a bereaved mother, Marianne Skolek, whose daughter died after being prescribed OxyContin, who seeks to punish executives of Purdue Pharma, the drug's manufacturer. I just noted that even when the actions of health care organizations result in legal penalties, very rarely do the organizations' leaders suffer any consequences. The OxyContin case was an exception to this rule, since the company's executives were actually fined significant amounts (see our post here). Ms Skolek is going further, and is seeking to have at attorney who worked for Purdue disbarred, and to have the company's former medical director lose his medical license. Stay tuned on this one....

9 comments:

MedInformaticsMD said...

Skolek's testimony to the Senate is here:

http://judiciary.senate.gov/testimony.cfm?id=2905&wit_id=6612

Marianne Skolek said...

Testimony
United States Senate Committee on the Judiciary
Evaluating the Propriety and Adequacy of the OxyContin Criminal Settlement
July 31, 2007
Marianne Skolek
,

--------------------------------------------------------------------------------

My name is Marianne Skolek. I had a beautiful 29 year old daughter named Jill. She had the misfortune of being prescribed OxyContin in January 2002 and was killed on April 29, 2002. Jill left behind her son Brian who was 6 years old at the time of his mom’s death. Brian is with me in the Senate today.

Why did a $9 billion privately held pharmaceutical corporation take the life of my precious daughter? My work against Purdue Pharma for the past 5 years initially focused on J. David Haddox, dentist turned psychiatrist and Senior Medical Director of Purdue Pharma. I also focused on Robin Hogen, former Public Relations spokesman for Purdue Pharma.

In 1996, the American Academy of Pain Medicine and the American Pain Society issued a set of guidelines for the use of opiates in the treatment of chronic pain. These guidelines are referred to as a “consensus statement.” The statement leaning toward a more liberal use of opiates was adopted just as the marketing push for OxyContin began. This consensus statement was produced by a task force, which was headed by J. David Haddox, former president of the American Academy of Pain Medicine, who was senior medical advisor for Purdue Pharma – the maker of OxyContin. Haddox was quoted as saying that “the point was to gather consensus. If you are going to do this, this is how it should be done.” There was question as to whether it was ethical for Haddox to be associated with a pharmaceutical manufacturer to guide the formation of a document that would play a key role in promoting the use of products made by the company – Purdue Pharma.

When OxyContin was introduced on the market, it was intended for the treatment of cancer patients and they were losing the patent on MS Contin. At one point, in the greed and sheer evil of Purdue Pharma, they intended to market OxyContin to OB/GYN patients. I flooded the country with emails and faxes to Attorney Generals and the media reporting that we had enough devastation in the country without addicting infants to OxyContin. This marketing ploy was terminated by Purdue Pharma.

Pain patients from various pain societies will speak of the merits of OxyContin and their quality of life being restored because of the drug. These pain societies throughout the country – are funded by Purdue Pharma. Let the pain patients not a part of any funded pain society of Purdue Pharma speak about the quality of life they have after becoming addicted to OxyContin – and when their physicians refuse to renew prescriptions for the drug – and they go on the street to buy the drug because they can’t kick the habit of this less addictive drug. Ask the FDA and the DEA why OxyContin is in such plentiful supply on the streets all over the country.

Jill and thousands of victims of an out of control, greedy pharmaceutical company headed by three convicted criminals marketed OxyContin as less likely to be addictive and abused. There are assertions that the only victims in the criminal activities of Purdue Pharma were the physicians who were misled by Purdue Pharma’s sales representatives. The physicians, who were used as pawns by Purdue Pharma, were not ingesting a powerful narcotic that was being marketed as less likely to be addictive or abused – the patients were ingesting OxyContin and were becoming addicted and dying. If patients aren’t victims of Purdue Pharma’s criminal activities, tell me what they should be called.

The addictions and loss of lives because of OxyContin continue to impact every state in the country every single day. The far reaching consequences of the criminal activity of Purdue Pharma did not end in 2001 or 2002 as they would like it to be believed – no one can turn the clock back. This has been allowed to become a national crisis because there was no conscience in the marketing of OxyContin – there was only greed.

We all hear on the news every day about individuals who work for government agencies or private industry who embezzle funds. Purdue Pharma has been found criminally responsible for marketing OxyContin which resulted in death and addiction. Is it justice to have these convicted criminals – these monsters – fined an amount of money that is very well afforded by them, or will the Senate send a message that because of the magnitude of the crime committed, they deserve to be further investigated by the Senate.

Anything that is imposed against these convicted criminals will not give us back Jill, but I will guarantee that Purdue Pharma will never forget the name Jill Skolek. When I began my work at exposing these three convicted criminals and Haddox and Hogen, I told Hogen that you messed with the wrong mother – and they did because my work is not over.

I want to know why the FDA allowed OxyContin to cause such destruction to the lives of scores of innocent victims. I want to know why 12 warning letters were sent by the FDA to Purdue Pharma about their marketing of OxyContin and to this day, they are not required to put “highly addictive” or “addictive” on the label of the drug. I want to know why the FDA deleted without reading so many of my emails about the marketing of OxyContin until this last month. I want to know why Curtis Wright while employed by the FDA played an intricate part in the approval of OxyContin and then was hired by Purdue Pharma. I want to know why Attorney General Blumenthal of Connecticut’s Citizen Petition which requests strengthened warnings for OxyContin as a result of information they uncovered in their investigation against Purdue Pharma has been sitting at the FDA – without any action – since January 2004. I want to know how Rudy Guliani could be the “big star” hired by Purdue Pharma to play down the abuse and diversion of OxyContin and also get paid by the DEA for work performed for them. I want to know why the Sackler family has not been held accountable for their involvement with Purdue Pharma and the mass marketing of OxyContin.

Eventually Purdue Pharma will introduce another blockbuster drug similar to OxyContin and as they did with another devastating drug called Palladone. Palladone was removed from the market after a couple of months. I like to think that my faxes and emails all over the country played an intricate part in having it removed. My advice to Purdue Pharma is when you are ready to introduce another drug such as OxyContin or Palladone, look behind you, because I will be right there.

I will be working at having Howard Udell disbarred for his criminal activities and Paul Goldenheim’s medical license revoked for what amounts to white collar drug trafficking. I will be actively working at Friedman, Udell and Goldenheim never being able to work in the pharmaceutical industry again because they are convicted criminals who criminally marketed OxyContin. I will accomplish this – hopefully with the help of Attorney General Blumenthal -- do not doubt me at not being successful at achieving this.

Her name was Jill Carol Skolek. She did not deserve to be prescribed OxyContin and die because of the criminal activities of individuals of Purdue Pharma . Please give my family justice and investigate the criminal activity of Purdue Pharma .

Thank you Senators for giving me the opportunity to speak for thousands of victims of an out of control pharmaceutical corporation.

Anonymous said...

9/12/07
The Advocate and Greenwich Time


By Peter Healy
Staff Writer
A South Carolina woman who blames her daughter's death in 2002 on the painkiller
OxyContin is trying to get Stamford-based Purdue Pharma LP's general counsel,
Howard Udell, disbarred in Connecticut.
Marianne Skolek, of Myrtle Beach, is also asking the Connecticut Department of
Public Health to revoke the medical license of Dr. Paul Goldenheim, Purdue's
former medical director.
In May, Purdue Pharma, Udell, Goldenheim and then-Purdue President Michael
Friedman pleaded guilty to federal misdemeanor charges of telling doctors that
OxyContin was less addictive and less subject to abuse than other pain
medications.
Designed to be swallowed whole and time-released over 12 hours, OxyContin can
produce a heroin-like high if crushed and then swallowed, snorted or injected.
OxyContin is a trade name for a long-acting form of the painkiller oxycodone.
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 Drug Enforcement Administration. In 2002,
the DEA said the drug caused 146 deaths and contributed to another 318.
A federal judge in June sentenced the Purdue Pharma defendants to pay a total of
$34.5 million in fines, while the company was fined another $600 million. The
Purdue executives also received three years of probation and 400 hours of
community service.
During the sentencing hearing, many of the nearly 20 speakers called for prison
terms for Friedman, Udell and Goldenheim, saying the fines were a small price
for the devastation that OxyContin addiction caused, published reports said.
Skolek said she was among those speakers.
Friedman retired in June and Goldenheim left Purdue in 2004. Udell is still
employed at privately owned Purdue, company spokesman James Heins said.
Purdue Pharma responded to Skolek's action with this statement:
"Michael Friedman, Howard Udell and Paul Goldenheim neither engaged in nor
condoned any of the misconduct that was the subject of this investigation, but
they have accepted responsibility for it solely because of their positions as
leaders of the company."
"When these individuals learned of this conduct, they took steps to prevent it
in the future. They also helped spearhead our efforts to combat illegal
trafficking and abuse of our medicine," Purdue Pharma said.
Heins said Purdue Pharma had no comment beyond the statement.
Skolek filed a grievance complaint Aug. 28 with the Statewide Grievance
Committee of Connecticut's Judicial Branch. Her complaint seeks to disbar Udell,
partly because of his guilty plea.
"My 29-year-old daughter Jill Carol Skolek was prescribed OxyContin by her
physician in January 2002 and was killed in April 2002 because her doctor told
her the drug was safe and had virtually no risk of addiction or abuse," Skolek
wrote in her complaint.
Skolek said she has filed a similar complaint in New York, where Udell is also
licensed to practice law.
Mark Dubois, chief disciplinary counsel for the Connecticut Judicial Branch,
said he has a file on Udell and is aware of a grievance complaint against him.
Dubois said he has the power to seek suspension or disbarment of Udell but has
not decided what action, if any, he will take.
Only a Superior Court judge can disbar a Connecticut lawyer, Dubois said. He
said Connecticut does not automatically disbar lawyers convicted of felonies
and/or misdemeanors, as some states do. Udell was admitted to the Connecticut
bar in 1983, a judicial branch spokeswoman said.
If Dubois takes no immediate action, the grievance process is lengthy. A
complaint against a lawyer goes from Connecticut's Statewide Grievance Committee
to a local grievance panel, said Michael Bowler, statewide bar counsel for
Connecticut.
The Statewide Grievance Committee has referred Skolek's complaint against Udell
to the Stamford-Norwalk Grievance Panel, according to a letter the committee
sent to Skolek. She sent a copy of the letter to The Advocate and Greenwich
Time.
In the complaint process, the local grievance panel investigates the complaint
and gives the defendant a chance to respond, Bowler said.
The grievance panel then looks for probable cause of misconduct, Bowler said.
If it finds probable cause, the panel files its finding with the Statewide
Grievance Committee, which then schedules a public hearing in front of one of
its subcommittees, he said. The committee issues a written decision as to
whether clear and convincing evidence of misconduct exists and decide what
sanctions should be imposed, Bowler said.
Sanctions can include the lawyer going before a Superior Court judge, who can
suspend or disbar the lawyer, Bowler said.
Dubois said each year about a half-dozen of the 34,000 people licensed to
practice law in Connecticut are disbarred.
He said about six to 12 attorneys per year are convicted of misdemeanor charges
of driving while intoxicated in the state and another half-dozen are convicted

Anonymous said...

On similar note we find Cephalon sending letters to doctors regarding it’s narcotic Fentora, the follow on to Actiq. The 9/14/2007 WSJ highlights Cephalon Drug Is Tied to Several Deaths.

The issue is off-label marketing of the drug and the company’s responsibility for these actions. “Any settlement would involve a large fine and require Cephalon take remedial measures to reform its aggressive marketing practices…”

I am sure this will be scant comfort to the families of the four who died or those now dealing with withdrawal.

Steve Lucas

Marianne Skolek said...

Could you please post Purdue Pharma's response to my action against them? I would like to respond to it.

Mareianne Skolek said...

Pls. disregard my previous email. I read within the article Heins' statement as the spokesperson for Purdue Pharma and it doesn't warrant a reply since the three convicted criminals Friedman, Udell and Goldenheim pled guilty to the charges against them and their corporation and were sentenced.

kim said...

What a shame that no one at all pays attention to the good this medication has done and how it has changed so many life's in a positive manner. Kimberly

Anonymous said...

Bless you, Marianne, for loving your daughter so deeply that you are exerting so much time and energy to help others avoid the horrifyingly, life-altering effects of Oxycontine. Our lives have been forever changed by this drug. Our sweet son graduated university in 2005, suffering from irritable bowel syndrome. He was prescribed Oxycodone and Oxycontine. Within two months, our athletic, considerate, ethical son changed drastically to a monster who we did not know. Within months, he lost his career job and, as time progressed, all of his friends. Our family stopped visiting, and my husband and I almost separated from our son's horrifying addiction-changed personality and life, and the constant upheaval, lies, stealing, lack of sleep, etc. Finally, on 30March 2007, our son modified a prescription (as he was needing more and more) and was arrested. He started the Methodone program, as trying to wean off Oxycontin caused very near death, terrifying experiences. His life has been almost destroyed by this drug, and he is struggling so hard to find employment, himself and make new friends. Our once very vivacious and popular son is now so insecure and almost reclusive -- after three years of "living" under the control of Oxycontin and then struggling to overcome it. Our hearts break daily as we watch him fight to find himself and re-establish his life. This should NEVER have happened to this wonderful young man. Oxycontine should never be prescribed to anyone who is not terminal. I cannot even begin to put into writing our badly all our lives have been affected. Thank God, we did not lose our sweet son. Daily, I pray that he does not give up the fight to overcome what this medication has done to his life. Our family is participating in the Canadian Class Action suit against Purdue. I can't image how profit can be put ahead of human life.

Arlene

Anonymous said...

Kim seems to be a bit retarded.