A SPECIAL REPORT FROM PYRAMID ONE NETWORK WORLDWIDE
)(*)((*)(*)(*)(*)(*)(*)(*)(*)(
PRESIDENT OBAMA SIGNED
OFF ON TURNING THE "FDA" OVER TO " BIG PHARMA", THEY CAN
NOW POISON US WITH "NO RESTRAINTS" BECAUSE THE FEDS DON'T POLICE THEMSELFS THE
FDA MUST BE STOPPED AND ERASED"
or
MORE WILL DIE !
The FDA now officially belongs to Big Pharma
Robert Califf's ties to the industry run deep, and the Obama nominee just sailed through the U.S. Senate
Topics:
AlterNet,
Big Pharma,
FDA,
Robert Califf,
Bernie Sanders, Politics News
Dr. Robert Califf(Credit: AP/Pablo Martinez Monsivais)
This article originally appeared on AlterNet.
It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved today as the next FDA commissioner. Vocal opponent Bernie Sanders condemned
the vote from the campaign trail. But where was Dick Durbin? Where were
all the lawmakers who say they care about industry and Wall Street
profiteers making money at the expense of public health?Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.
Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.
In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?
Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?
He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)
Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Xarelto’s serious and foreseeable risks were back in the news this week.
AND
BOB CHARLES SAYS
Make
sure the NEXT President DOES THIS !
Before we are all Poisoned
December 11, 2015, 09:00 am
The nearly 3.2 million Americans suffering from this illness received hope in 2014 with the release of a new drug, Sovaldi. The medicine is nothing short of a godsend for patients. While older treatments are long and not very effective and have a variety of nasty side effects, 90 percent of people taking Sovaldi can expect to be cured in as little as 12 weeks.
The catch? Each pill costs $1,000. A typical course of treatment runs about $84,000. People have been quick to point out that the price of the drug is prohibitively expensive for many individuals, especially those without adequate medical insurance.
However, before we go pointing the finger at “capitalistic greed,” it’s important to ask some additional questions. Why is only one company allowed to make this product? Why have other competitors not come to the market with cheaper alternatives?
The culprit isn’t capitalism; it’s government, in particular, the Food and Drug Administration (FDA).
The FDA ensures that medicines are “safe,” but the process is agonizingly slow. Currently it takes years to bring new drugs to market. One study found that from 1938 to 2014 the FDA approved only a fraction of the drugs submitted. More important, many approvals were given to but a few companies, namely, Merck, Roche, Johnson & Johnson, Eli Lilly, and Pfizer.
This process generates three important effects. First, it effectively grants a government-protected monopoly to those companies. The FDA approval process is so expensive that many smaller companies without the necessary financial resources are prevented from competing. By preventing competitors from coming onto the market, the FDA eliminates the market forces that preclude monopolies. The results are higher prices and fewer drugs, that is, fewer options for patients. For hepatitis patients facing a $1,000 pill, this may literally be a life-and-death issue.
Second, the FDA-approval process can increase drug costs by hundreds, even thousands of dollars. Take Provenge, a prostate-cancer drug. Despite its proven efficacy, FDA mandates have prevented it from going on the market for a full eight years. Researchers estimate that as a result of this delay, patients lost a total of 82,000 years of life. The multiple clinical trials required by the FDA to bring the drug to market meant that the drugmaker needed to increase the price substantially to cover its losses. When the drug was finally released, the therapy cost some $93,000.
The third problem is perhaps counterintuitive. The FDA is said to be necessary to keep unsafe and ineffective drugs off the market because doctors, swayed by pharmaceutical reps or lacking proper information, would prescribe dangerous drugs or worthless to their patients. Actually, in a free market, drug companies and doctors would face strong incentives to make and prescribe medicines that are both effective and safe. If a company manufactured an ineffective drug, it would quickly lose customers in a competitive marketplace. Similarly, if a company created unsafe drugs, it would not only lose customers but would likely be sued. In the same way, a doctor looking to maintain his reputation and practice would face strong free-market incentives to prescribe only safe and effective medicines.
In contrast, FDA regulations encourage both doctors and patients to get lazy about their care. If the FDA is presumed to vouch for the safety of drugs, patients and doctors have less incentive to be concerned about safety themselves. However, the FDA’s track record gives us scant grounds for confidence in the safety of drugs. Between 2004 and 2014 the FDA recalled more than 4,200 medicines. Some 362 were Class I recalls, meaning exposure to drugs could cause serious health consequences and even death.
It’s time to rethink the FDA. While regulating drugs for the sake of the public may sound appealing, it arguably does more harm than good. Ultimately, the FDA increases prices to consumers, slows the production of life-saving drugs, and is alarmingly ineffective.
Time to do away with the FDA
Getty Images
For
individuals suffering from hepatitis C, a blood-borne virus causing
liver inflammation, life can be difficult. For 70-85 percent of those
with the virus, the condition is chronic, with effects ranging from liver infection to cirrhosis to death. The nearly 3.2 million Americans suffering from this illness received hope in 2014 with the release of a new drug, Sovaldi. The medicine is nothing short of a godsend for patients. While older treatments are long and not very effective and have a variety of nasty side effects, 90 percent of people taking Sovaldi can expect to be cured in as little as 12 weeks.
The catch? Each pill costs $1,000. A typical course of treatment runs about $84,000. People have been quick to point out that the price of the drug is prohibitively expensive for many individuals, especially those without adequate medical insurance.
However, before we go pointing the finger at “capitalistic greed,” it’s important to ask some additional questions. Why is only one company allowed to make this product? Why have other competitors not come to the market with cheaper alternatives?
The culprit isn’t capitalism; it’s government, in particular, the Food and Drug Administration (FDA).
The FDA ensures that medicines are “safe,” but the process is agonizingly slow. Currently it takes years to bring new drugs to market. One study found that from 1938 to 2014 the FDA approved only a fraction of the drugs submitted. More important, many approvals were given to but a few companies, namely, Merck, Roche, Johnson & Johnson, Eli Lilly, and Pfizer.
This process generates three important effects. First, it effectively grants a government-protected monopoly to those companies. The FDA approval process is so expensive that many smaller companies without the necessary financial resources are prevented from competing. By preventing competitors from coming onto the market, the FDA eliminates the market forces that preclude monopolies. The results are higher prices and fewer drugs, that is, fewer options for patients. For hepatitis patients facing a $1,000 pill, this may literally be a life-and-death issue.
Second, the FDA-approval process can increase drug costs by hundreds, even thousands of dollars. Take Provenge, a prostate-cancer drug. Despite its proven efficacy, FDA mandates have prevented it from going on the market for a full eight years. Researchers estimate that as a result of this delay, patients lost a total of 82,000 years of life. The multiple clinical trials required by the FDA to bring the drug to market meant that the drugmaker needed to increase the price substantially to cover its losses. When the drug was finally released, the therapy cost some $93,000.
The third problem is perhaps counterintuitive. The FDA is said to be necessary to keep unsafe and ineffective drugs off the market because doctors, swayed by pharmaceutical reps or lacking proper information, would prescribe dangerous drugs or worthless to their patients. Actually, in a free market, drug companies and doctors would face strong incentives to make and prescribe medicines that are both effective and safe. If a company manufactured an ineffective drug, it would quickly lose customers in a competitive marketplace. Similarly, if a company created unsafe drugs, it would not only lose customers but would likely be sued. In the same way, a doctor looking to maintain his reputation and practice would face strong free-market incentives to prescribe only safe and effective medicines.
In contrast, FDA regulations encourage both doctors and patients to get lazy about their care. If the FDA is presumed to vouch for the safety of drugs, patients and doctors have less incentive to be concerned about safety themselves. However, the FDA’s track record gives us scant grounds for confidence in the safety of drugs. Between 2004 and 2014 the FDA recalled more than 4,200 medicines. Some 362 were Class I recalls, meaning exposure to drugs could cause serious health consequences and even death.
It’s time to rethink the FDA. While regulating drugs for the sake of the public may sound appealing, it arguably does more harm than good. Ultimately, the FDA increases prices to consumers, slows the production of life-saving drugs, and is alarmingly ineffective.
