Pfizer Recalls 28 Lots of Birth Control Pills

The Philadelphia Inquirer reports that Pfizer has recalled 28 lots of birth control pills, principally Lo/Ovral-28 tablets and Norgestrel and Ethinyl Estradiol tablets. The recall was caused by problems with "ingredients and sequence of the medication."

　
Apparently, the tablets were manufactured and packaged by Pfizer Inc., and marketed by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. Pfizer says the problems were caused by packaging errors that resulted in disruption of the daily regimen of contraceptives. The disruption "could leave women without adequate contraception, and at risk for unintended pregnancy." Pfizer claims the packaging defects "do not pose any immediate health risks," but, warn "consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately," notify their physician, and return the product to the pharmacy.

MDs peddling BS: Shedding Light on Doctors’ Conflict of Interest

The Washington Post reports that determining doctors’ ties with pharmaceutical companies and any related conflict of interest are often hard, if not impossible, tasks for patients.

The Physician Payments Sunshine Act, introduced by Sens. Chuck Grassley and Herb Kohl, seeks to relieve some of that burden by requiring all payments more than $100 made by a drug or medical device company to a doctor be reported.

Doctors justify the “pharmaceutical pay-off” saying that the "doctor/industry partnership" is often needed to help develop beneficial new drugs.

But, the “doctor/industry partnership" is circular reasoning. Here’s the effect: Doctors argue that, with the help of doctors, the pharmaceutical companies develop so-called "new drugs," which the doctors then prescribes to patients, who then pay "big bucks" for the "new-drugs," so that the pharmaceutical company can make "big bucks" to “pay-off” the doctors.

It appears that the “MDs” are peddling “BS.” See, Ibby Caputo, The Washington Post 08/18/2009 Read Article: The Washington Post

Judicial Secrecy And Seroquel, Shrouded In Controversy.

Pharmaceutical manufacturers use "judicial secrecy" to protect themselves and hide evidence of a drug’s harmful side-effects, evidence the public has a right to know. But a group of lawyers have had enough.

Here’s what happened.

AstraZeneca manufactures Seroquel, the pharmaceutical trade name for quetiapine, a potent anti-psychotic that some believe mediate through antagonist activity at dopamine and serotonin receptors. Although the FDA had only approved Seroquel for schizophrenia and bipolar disorders, AstraZeneca had been marketing the drug to patients suffering from depression and anxiety, even though all disorders are not the same.

In 2001, Ted Baker, who lives in Bastrop, LA, was diagnosed with post-traumatic stress disorder, a depressive disorder. His doctor prescribed Seroquel. Baker, like many consumers of Seroquel, experienced “drastic weight gain” in a short time period. In 2004, Mr.Baker was diagnosed with Type II diabetes. However, Mr. Baker never knew and was never warned that the Seroquel had this dangerous side effect.

Now, after the fact, AstraZeneca wants the FDA to “expand” the use of Seroquel to include patients with depression and anxiety. Mr. Baker’s lawyers and many other lawyer believe that the “judicially sealed documents” surrounding Seroquel may well shed some light on the side effects of the drug. It seems that AstraZeneca “buried” unfavorable studies on the drug, according to an internal e-mail unsealed as part of litigation over the drug. The lawyers want all of the documents released to the FDA before the drug is officially approved for expanded use.

The problem, here, arises out of "judicial secrecy," which has been on the rise since the 1980s. It reached a climax in the 1990s. Without justification, indifferent conservative judges often willingly issue broad based "secrecy orders," protecting corporate predators and hiding evidence of inferior or bad pharmaceuticals from consumers.

To partially cure the problem, judicious secrecy needs to stop! To completely cure the problem, there needs to be corporate responsibility!

Here is the full release on the AstraZeneca case: Full release on the AstraZeneca case

Also, here are a few links to stories written on the case:

Associated Press: AstraZeneca challenges witnesses in Seroquel suit

Bloomberg: AstraZeneca Seroquel Studies ‘Buried,’ Papers Show (Update3)

Preemption: The Theft Of Your Civil Liberties

Help for workers and consumers is on the way. "Complete Immunity" is out; fairness is in.

Pres. Obama is poised to reverse the Bush administration's “COMPLETE IMMUNITY DOCTRINE,” a radically conservative doctrine that uses PREEMPTION to give complete immunity to negligent corporations. Preemption deprives workers and consumers of the right to hold wrongdoers accountable through the civil justice system. The Bush administration has used preemption to deprive Americans of several fundamental, traditionally American civil liberties, most notably the right to trial by jury and the right of access to the courts.

To reverse the injustice, the Obama administration needs to immediately implement the following:

(1) Issue an immediate stay order of all "non-final or recently completed rules" that PREEMPT state law protecting workers and consumers. At this time, there are 23 preemptive regulations, including several dealing with auto safety and products requiring FDA approval.

(2) Revise Executive Order 13132 on Federalism, instructing agencies and the courts regarding the Obama administration’s policy of "NO PREEMPTION TO DENY CIVIL LIBERTIES." The Obama administration should make it clear: PREEMPTION is THEFT of CIVIL LIBERTIES!

(3) Establish a White House office to coordinate and implement a "NO PREEMPTION TO DENY CIVIL LIBERTIES" policy, carefully overseeing the preemption language included in all federal rules.

(4) Utilize the rule making process to reinstate Congressional intent regarding the ability of injured consumers to hold medical device manufacturers accountable for injuries to consumers. In Riegel v. Medtronic, Sup. Ct. Justice Antonin Scalia "misconstrued the Medical Device Amendments of 1976," and gave all irresponsible medical device manufacturers "complete immunity" from claims regarding their Class III pre-market approved devices. The FDA needs to withdraw its August 2008 final rule regarding labeling. The rule discourages medical device manufactures and pharmaceutical companies from updating warning labels with hazard information without prior FDA approval, a blatant attempt to influence the Supreme Court’s decision in Wyeth v. Levine (argued November 3, 2008).

(5) Issue new rule making guidelines for rules containing PREEMPTION language. Agencies like the FDA and NHTSA have become SUPER-LEGISLATORS, implementing agency policies contrary to the Constitution’s separation of powers and explicit Congressional intent. Here are some examples:

70 Fed. Reg. 36094 (2005) and 73 Fed. Reg. 58887 (2008) give automobile manufacturers BLANKET IMMUNITY from lawsuits, literally a "get-out-of-jail-free" card, for making vehicles with an insufficient number of seat belts. Yet, many states have laws that make illegal for driver and passengers not to "buckle-up."

71 Fed. Reg. 76852 (2006) and 73 Fed. Reg. 72130 (2008) "establishes minimum security requirements for railroads to transport hazardous materials." This rule gives railroads COMPLETE IMMUNITY if they injure local residents, directly contradicting recent legislation.

Remember, PREEMPTION is THEFT of YOUR CIVIL LIBERTIES!

Eli Lilly to Disclose Financial Ties to Doctors, a Drug Industry First

It's about time!

In an effort to quell public anger, pharmaceutical giant Eli Lilly & Co. says it will create a "public database" listing the names of the physicians on Lilly's payroll for speaking engagements and consulting services. The AMA should prohibit doctors from hawking drugs for pay without public disclosure. The conflict of interest that is open and obvious with such practices is lethal with certain medications!

If it lives up to its pledge, Lilly will be a leader in the pharmaceutical industry toward greater transparency. Lilly's program is set to begin in 2009 and to be fully implemented in 2011. The Lilly program is modeled after federal legislation authored by Senate Aging Committee Chairman Herb Kohl (D-Wis.) and Finance Committee ranking member Chuck Grassley (R-Iowa).

Lilly decided to advance the transparency policies on its own because policymakers and the public are demanding drug companies be more open. Read: Jeffrey Young, The Hill, 9-24-08, Eli Lilly to disclose financial ties to doctors

Dr. Frederick K. Goodwin, Psychiatrist Radio Host Tied to Drug Company Payments

The U.S. Senate is investigating Dr. Frederick K. Goodwin, a psychiatrist and host of "The Infinite Mind," a popular NPR radio program. Goodwin allegedly received more than $1 million in fees fro m drug makers between 2000 and 2007. According to reports, Goodwin failed to disclose that he was receiving payments from drug makers for treatments covered during his radio show.

Goodwin's problems surfaced as part of a larger Senate investigation into potential conflicts of interest by doctors. The Senate investigation is lead by Sen. Charles E. Grassley (R-Iowa). Read Article: The New York Times

Effectiveness, Safety of Zetia and Vytorin, Cholesterol Drugs, in Doubt

Zetia and Vytorin are two widely prescribed cholesterol drugs. Both drug are marketed and sold by Schering-Plough and Merck.

Cardiologists have been demanding Schering-Plough and Merck come forward with clinical trials to prove the drugs’ effectiveness and safety. Cardiologists fear that if the drugs prove to be less effective than advertised, patients may be putting themselves at unnecessary risk of heart attacks. Approximately 800,000 Americans are prescribed Zetia and Vytorin each year.

So far neither Schering-Plough nor Merck have published the results of Zetia and Vytorin trials. This ain’t Denmark, but something’s rotten here.

And this also ain’t Kansas, so the wizards at Schering-Plough and Merck better publish the data, if it’s true. 800,000 live depend on it!

Alex Berenson, The New York Times 11/21/2007 Read Article: The New York Times

FDA Convenes on Cold Drugs for Youngsters

A group of pediatricians told FDA advisers that cold and cough medicines should not be given to children under six years old.

An FDA panel is currently considering a petition that seeks government recognition that the medicines are ineffective and unsafe for children under six years of age.

Meanwhile, drug makers stopped the sale of over-the-counter medicines for toddlers citing potential for overdoses.

See, Andrew Bridges, LA Times 10/18/2007 Read Article: LA Times

Drug Maker to Block Sale of Low Cost Cancer Drug

The good and bad of money…money…. money!

Pharmaceutical giant Genetech makes Avastin, a cancer drug that is also used to treat macular degeneration, which causes blindness in the elderly. Genetech also makes Lucentis, a drug used to treat macular degeneration. And, that’s good!

But, here’s the problem: Retinal specialists prefer to use Avastin because of its cheaper, about $50 a dose, while Lucentis costs about $2000 a dose. And, that’s good!

If it keeps making Avastin, Genetech will lose $1950 per dose. So, Genetech has told retinal specialists that it not going to produce Avastin, because Lucentis is “really-really-no-joke-pinky-swear” better than Avastin. And, that’s bad!

Elderly folks can’t afford a drug that cost $2000 a dose to prevent blindness, so they’ll go blind. And, that’s bad!

Andrew Pollack, The New York Times 10/12/2007 Read Article: The New York Times