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2007年12月17日星期一

What Doctors Are Saying About Primary Pulmonary Hypertension and Fen-Phen

While some organizations and individual physicians are very careful in their efforts to be vague, or even tangential, about the relationship between PPH (Primary Pulmonary Hypertension) and fen-phen, others openly reveal what is known about this association.

Ronald J. Oudiz, M.D., Director of Pulmonary Hypertension, Associate Professor, Department of Medicine, Division of Cardiology, Harbor-UCLA Medical Center indicated (emedicine) that:

PPH (Primary Pulmonary Hypertension), more recently termed IPAH (Idiopathic Pulmonary Arterial Hypertension) has been associated with anorexigens and other alpha-adrenergic stimulants (fen-phen). How these associated conditions predispose to, or cause, PPH remains unknown.

In the US, IPAH (PPH) is responsible for approximately 125-150 deaths per year.

Typically, younger women of childbearing age develop IPAH (PPH). However, it can also affect women in their fifth and sixth decades of life or older.

The mortality rate for untreated IPAH (PPH) is approximately 50% at 3 years (varies with severity at presentation).

The American Heart Association indicates that an estimated 500 to 1,000 new cases of PPH are diagnosed each year in the United States. The greatest number is reported in women between the ages of 20 and 40. However, men and women in all ages and very young children develop PPH.

Appetite suppressants (fen-phen) are one of the factors believed to trigger the constriction, or narrowing, of the pulmonary artery.

One website devoted to information about Primary Pulmonary Hypertension states that PPH or Pulmonary Arterial Hypertension may be linked to the diet drug fen-phen:

A significant association exists between the use of the fen-phen diet drug and PPH. Studies have shown that it can be several years (ten or more) after having stopped taking diet drugs that patients develop the disease.

The American Lung Association reports that, in 2000, there were 3,065 deaths attributed to PPH. This organization also states: The use of certain appetite suppressants (fen-phen) has been found to increase the risk of developing PPH, especially use lasting more than three months.

They report that studies estimate that treatment with certain appetite suppressant drugs (fen-phen) increases the risk of getting PPH from approximately 1, to 28 cases per million person-years (one person-year represents a patient treated for one year). Two drugs associated with PPH, fenfluramine (one of the components of fen-phen) and dexfenfluramine, were taken off the market in September 1997 after being linked to heart valve damage.

The National Heart Lung and Blood Institute identifies factors that appear to increase the chances of developing PAH (pulmonary arterial hypertension. They include the use of appetite suppressants, especially fenfluramine (fen-phen) and dexfenfluramine.

2007年12月15日星期六

What the State of California Has to Say About Fen-Phen Related Legislation

Phen-fen (or fen-phen), has been linked to serious medical complications that, in turn, led to a flurry of lawsuits and efforts to legislate reform redefining approval of new drugs and to curb the activity of trial lawyers.

UCLA Today (September 29, 1997), referencing the fact that legislation was held up over a statewide ban of fenfluramine (a component of phen-fen) reported:

-EPIDEMIC OF OBESITY WILL NOT BE SATED BY FEN-PHEN BAN-

The breast-beating in recent days over the perceived dangers of drugs to treat obesity has both positive and negative overtones. Litigation was initiated by reports of severe heart-valve abnormalities in a group of patients taking dexfenfluramine, or Redux, and fenfluramine, Pondimin, which is one of the drugs used in the popular phen-fen combination.

Among the positive side effects will be the closure of commercial phen-fen clinics. On the negative side, however, many other "practicioners" will move in to fill the void in a rush to reap the $30 billion annual windfall spent in the often desperate effort to slim down.

Senator Diane Feinstein made the following comments about the Class Action Fairness Act in July of 2004, citing a pharmacy owner sued for dispensing phen-fen:

Lawsuits were brought against the manufacturer of phen-fen, but the only pharmacy in the county was also named to keep the case in place already known for its lawsuit-friendly environment, according to the owner who was sued more than 100 times.

"I wish to speak in favor of the bill."
"Supporters of this bill have clearly identified this problem and have come up with a reasoned solution."
"This abuse comes from just some class action lawyers, who forum shop national class action lawsuits and file them in States and counties where they know the court will approve settlements favorable to them."

"The Class Action Fairness Act goes a long way toward stopping forum shopping by allowing Federal courts to hear national class action lawsuits that involve plaintiffs and defendants from different States and which involve more than 5 million in claims."

"The bill contains a consumer class action bill of rights'...To provide greater information and greater oversight of settlements that might unfairly benefit attorneys at the expense of truly injured parties."

"It bans settlements that actually impose net costs on class members."

"It requires that all settlements be written in plain English."

Richard Alexander (personal injury specialist) in Confidential Settlements Should Be Banned in California (The Consumer Law Page) stated:

"California law should end confidentiality in legal settlements that hides evidence of dangerous products (phen-fen), environmental hazards or financial fraud. Secrecy should only be allowed to protect constitutional rights to privacy, trade secrets, or confidential personal or business information."

A letter (CALA News) to Governor Schwarzenegger from CALA stated:

"California Citizens Against Lawsuit Abuse (CALA) respectfully request that you veto Senate Bill 1489 as it is inherently unfair and could actually lock the courthouse door."

"The threat of having to pay the AG's costs is a formidable weapon against even mounting a defense. No one should be discouraged from trying to defend themselves because of the fear of being saddled with outrageous costs."

Californians passed Proposition 64 to ban lawsuits without proof of harm, lawsuits filed on behalf of the public and not specific plaintiffs.

CALA defined Proposition 79 as legislation that lets personal injury lawyers file frivolous shakedown lawsuits every time a prescription is filled.