Birth Defects and Topamax

(The latest statistic from one of the watchdog/whistleblower sites I frequent is that 5 of 6 prescription drugs released on the market are virtually ineffective for the illness for which they are prescribed, and in most of those cases the placebo group had equal or better results than the control group did. And they ALL have so many side effects. There is NO SUCH THING as a prescription drug which carries no side effects. These are not miracle cures, they are chemicals which keep you sick by only dealing with your symptoms, not the cause of those symptoms. This is a big deal, because they make patients into repeat drug users by keeping them coming back. Nothing is ever cured. There's no money in the cure. Some vaccines are successful but many of them aren't (like the Gardasil and H1N1 vaccines for starters) and they all come with pages of horrible side effects listed--the remedy more often makes the patient's health even worse.

Topomax is the latest side effect laden useless drug screwing with people's health.--jef)

The Mother of All Side Effects
By MARTHA ROSENBERG

Americans are getting used to the withdrawal or severe restriction of drugs "previously thought safe." From last year's Avandia warnings to the withdrawal of Vioxx, Bextra, Baycol, Meridia, Trovan and Fen Phen, "Pill Buyer Beware" seems to be a shrewd stance, especially when a drug is new.

Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.

But this month FDA issued a warning that pregnant women who take the antiepileptic drug Topamax are twenty times as likely to have their babies develop cleft lip and cleft palate as they would otherwise be, says Reuters. Children are three times as likely to develop the facial anomalies as infants exposed to other seizure drugs, adds the Associated Press.

Johnson & Johnson's Topamax is FDA-approved to treat seizures and migraine headache. But like the off-label marketed seizure drugs Neurontin and Lyrica (for which Pfizer paid massive fines), J & J agreed to a $6.1 million fine for illegally marketing Topamax for psychiatric conditions, less than a year ago.

And the marketing worked. Thanks to J & J's subsidiary Ortho-McNeil's "Doctor-for-a-Day" scheme in which it paid outside physicians to call on health care providers along with sales reps and speak at meetings and dinners, according to the AP, Topamax made J & J a cool $2 billion a year by 2006. (A lot less than the $6.1 million it paid in criminal fines for the marketing that made the $2 billion.)

Thanks to wide marketing, Topamax has become such a catch-all drug in the military for general pain conditions and other unapproved uses (often in untested psychoactive drug "cocktails" which are now under investigation) it's called "Stupamax" because of its brain-fogging properties says Army Times.

Nor is this month's alert the first safety warning for Topamax.

As early as 2004, FDA warned J & J its sales pieces downplayed the "serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis," a violation of the Federal Food, Drug and Cosmetic Act. "These materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients," said FDA.

In 2006, FDA warned that Topamax can cause a serious eye condition "characterized by acute myopia and secondary angle closure glaucoma." The eye side effects can lead to "permanent loss of vision," if medical care is not sought, says the prescribing information.

In 2008, FDA warned that patients on all antiepileptic drugs should be "monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," and warnings on drug labels were soon required.

And last year FDA refused to approved a diet drug candidate, Qnexa, which includes Topamax along with phentermine, the "good" drug in the Fen Phen combo, because of surfacing Topamax doubts.

Qnexa probably would have worked as a diet drug. People who have used Topamax on the drug rating site askapatient say it does decrease appetite. But the action stems from Topamax making food and drinks taste terrible write more than 33 people. Others say in addition to making you lose weight, Topamax makes you lose your memory, word recall and even hair. Line forms to the left.

Of course widely promoted drugs which turn out to be dangerous after millions use them is nothing new. Many are calling for an end to the pharma Wild West in which even after fines for illegal drug marketing and personal injury settlements, pharma still profits and no principals go to jail.

Especially after Topamax's new side effects.

Chemical Industry to Nation's Infants & Toddlers: Suck It (Up)

Thursday, November 18, 2010 by NRDC Blog
by Daniel Rosenberg

In the major food safety legislation that the Senate is debating, which will likely pass today or tomorrow, one important provision will probably be missing: a ban on bisphenol A (BPA) in baby bottles or sippy cups.  The provision wasn’t included in the bill, and an amendment to add it before passage wasn’t able to get a vote on the floor of the Senate, due in large part to objections from the chemical  industry – represented in Washington DC by its trade association The American Chemistry Council (formerly known as the Chemical Manufacturers Association).

Give the chemical industry some credit: it has been acting consistently for years, even decades, to oppose any meaningful regulation of chemicals at the federal or state level, spending hundreds of millions of dollars and blocking protection for the public from chemicals that cause cancer, birth defects and learning and developmental disabilities.  And yet, blocking passage, or even a vote, on an amendment to ban bisphenol A in baby bottles and sippy cups still seems like a new low.

Senator Dianne Feinstein has emerged as a strong national leader in the fight for strong public protections from toxic chemicals, especially chemicals to which people are most widely exposed.  She was instrumental in banning three phthalates commonly used as plasticizers in childrens’ toys, and suspending the use of three others pending additional study by the Consumer Product Safety Commission.  That was a fight the chemical industry lost, largely because no Senator was willing to stand on the floor of the U.S. Senate and publicly oppose her efforts.  The chemical industry learned its lesson from that fight, and, in the battle over bisphenol A, the industry was determined to prevent her provision from making it into legislation, or ever allowing it to come up for a vote. According to at least one report, North Carolina Senator Richard Burr has been working with the chemical industry behind the scenes to block the Feinstein provision from being included in the bill.

The food industry, represented by the Grocery Manufacturers Association, has also gone to great lengths to prevent Senator Feinstein from successfully restricting the use of BPA, or fully assessing its potential effects on women and children.  But that is a story for another post.  At the end of the day, the Grocery Manufacturers were willing to go along with legislation that at least banned the use of BPA in baby bottles and sippy cups (where GMA members have less of a direct interest), and that required FDA to complete a safety assessment and determine whether BPA met the safety requirements of the Food Drug and Cosmetic Act by December 2012.

But the chemical industry couldn’t even stomach that.  The ACC – whose members include some of the largest chemical companies in the world such as BASF, Dow, and DuPont and other plastics manufacturers -- has spent millions of dollars to defeat state-led efforts to restrict the use of bisphenol A in infant formula, baby food, baby bottles and sippy cups.  They’ve had a poor return on that investment, though. To date, seven states have adopted some version of restrictions on the use of BPA, along with the City of Chicago.

A little more than a year ago, the ACC, the GMA, and several industry lobbyists and representatives of companies including Coca-Cola and Del Monte met at a private club in Washington DC to plot a strategy for defeating more of those state led-efforts.  Minutes from that meeting ended up in the hands of the Washington Post and the Milwaukee Journal Sentinel which both ran stories about industry’s plans.   These included searching for a pregnant mom to be a spokesperson for BPA, buying the support of scientists, and convincing African-Americans and Hispanics that a ban on BPA in infant formula and baby food would make those products unavailable where they lived.

The industry had one temporary victory in California this year, where it spent millions of dollars to defeat legislation to ban BPA in children’s food products.  The industry (which has continually complained about the “high cost” of complying with the most basic proposals from EPA or Congress to expand the public’s right to know about what products contain toxic chemicals, and which chemicals people should be concerned about) can look forward to spending millions more dollars in California in the near future.  But don’t worry, industry profits remain healthy during these tough economic times. And they’ve shown that they’ll spend whatever it takes on lobbyists, paid scientists, misleading ad campaigns, and, of course, campaign contributions to member of Congress, to ensure that they can block as much reform as possible.

The industry will say: all of the hundreds of peer-reviewed studies by independent scientists not funded by the chemical industry that show strong associations between BPA and breast and prostate cancer, as well as effects on the reproductive system are wrong, mistaken, etc. etc.  My colleague Dr. Sarah Janssen and many others have responded to those bogus charges repeatedly.  But, even if we acknowledge that everything there is to be known about BPA is not yet known, that is hardly an argument for keeping BPA in baby bottles, sippy cups, or any other packaging where it can migrate into our food supply.  BPA is routinely found in more than 90% of us, even though it is quickly excreted from our bodies (we pee it out).  That means we are essentially being exposed to BPA constantly, and the major source of that exposure is our food (including beverages).  BPA crosses the placental wall, which means the developing fetus is being exposed in utero (not only to BPA, but to dozens, and possibly hundreds of other toxic chemicals).

The failure to protect the public from constant exposure to BPA is one part of a much larger problem: our current laws do not protect us from unsafe chemicals, and keep us in the dark about the potential effects of thousands of others, which may be unsafe.  That is why NRDC and our coalition, the Safe Chemicals Healthy Families campaign, is working to reform the Toxic Substances Control Act (TSCA).

The chemical industry has given lip service to supporting TSCA reform and the need to protect children from unsafe chemicals (the trick being that, in the chemical industry’s view, there are no unsafe chemicals). The Feinstein amendment was an attempt to take a tentative baby step toward reform.  But the Chemical Industry snuffed it out.  So, big win for chemical industry lawyers on K Street.  For the children of America and their parents?  Not so much.