Drug Company Corruption, Pfizer Edition

The level of pharmaceutical company corruption is breathtaking.

A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.

“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.

The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.

The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.

 

As We Await the Supreme Court Health Care Decision, Remember the Impact on Individual Lives

From today’s New York Times:

His wife called every major insurance company she found on the Internet, but none would cover him: His cancer was a pre-existing condition. In desperation, the Richters agreed to pay half their hospital bill, knowing they could never afford it on their combined salaries of $36,000 a year.

No other group of Americans faces higher stakes in the impending Supreme Court ruling on the Affordable Care Act than those with pre-existing conditions. The law, once its major provisions take effect, would prohibit insurance companies from turning people away or charging them more because they are sick. In exchange, most Americans would be required to have insurance, broadening the base of paying customers with an infusion of healthy people. Those who did not buy insurance would be subject to financial penalties.

The Government Accountability Office estimates that 36 million to 122 million adults under 65 have a pre-existing condition. As many as 17 million do not have insurance. Many try to buy coverage on the individual market, but in most states that is either impossible or too costly.

 

Gambling with Our Genetic Future: GMOs and the World Food Supply

This interview with Jeffrey Smith appears in the June 2012 issue of Pathways, a Washington, DC, community quarterly. The web version here includes a list of references at the end which is not included in the print version.

Jeffrey M. Smith is a consumer advocate who has written extensively about genetically modified organisms (GMOs). As executive director of the Institute for Responsible Technology, he advocates against their inclusion in the food supply.

In this interview with Dr. Daniel Redwood, Smith describes the scientific studies that raise red flags about the safety of GMOs; several European nations’ current bans on GMOs in foods and how their regulatory processes differ from the United States; the British scandal in which veteran scientist Arpad Pusztai’s work was suppressed until revealed by a Parliamentary inquiry; court documents revealing that FDA scientists were overruled by a political appointee to allow the first introduction of GMOs into the U.S. food supply in the 1990s; and the revolving door that has allowed a top Monsanto official to rotate back and forth multiple times between corporate and regulatory positions of power in the U.S. federal government.

Smith also explains that as a non-scientist writer and advocate, he follows a policy of having his writing reviewed for accuracy by at least three scientists prior to publication.

Smith’s first book was Seeds of Deception: Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You’re Eating. His second, the comprehensively documented Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, covers research linking GMOs to a wide variety of health risks in humans and animals. In his foreword to Genetic Roulette, former UK Environment Minister Michael Meacher writes, “This is a brilliant book which combines shrewd dissection of the true nature of GM technology, a devastating critique of the health and environmental hazards of GM crops, and scarifying examples of the manipulation of both science and the media by the biotech industry.”

Jeffrey Smith has lectured in 30 countries and has been quoted in The New York Times, Washington Post, BBC World Service, Nature, The Independent, Daily Telegraph, New Scientist, The Times (London), Associated Press, Reuters News Service, LA Times, Time Magazine and Genetic Engineering News. His radio and TV appearances have included BBC, NPR, Fox News, Democracy Now and the Dr. Oz Show. He writes an internationally syndicated column, Spilling the Beans, and has a regular blog on The Huffington Post.

Pulitzer Prize winning ecological poet and essayist Gary Snyder was once asked what he feared most. This was a broad question—his answer could have been Alzheimer’s, starvation, fascism or anything else. His answer was, “Contamination of the gene pool.” You’ve devoted your life to this issue. To begin at the beginning, what is a genetically modified organism and how do these GMOs become part of the food supply?

GMOs are organisms—plant, animal, etc.—where genes from the DNA of one species are forced into the DNA of other species. In our food supply, foods like soybeans and corn have been genetically engineered with bacteria genes, allowing the crop to withstand doses of herbicide, or in the case of corn, to also produce their own toxic pesticide.

They were introduced into our food supply through deception and manipulation. The person in charge of policy at the FDA was Michael Taylor, the former attorney to biotech giant Monsanto, who claimed in the policy of the FDA that the agency was not aware of information showing that these foods were significantly different. Therefore, companies like Monsanto, who had previously told us that PCBs, Agent Orange and DDT were safe, were able to determine whether their GMOs were safe–no safety studies were required. They can introduce a new GMO without having to tell the FDA or consumers.

But documents made public from a lawsuit, Alliance for Biointegrity v. Shalala, revealed that the policy at the FDA was based on a lie. In fact, the overwhelming consensus among the FDA’s own scientists was that genetically modified foods were not only different but dangerous and could create hard-to-detect allergens, toxins, new diseases and nutritional problems. They had urged their superiors to require testing but were ignored.

Michael Taylor then went on to become Monsanto’s Vice President and chief lobbyist.  He is now back at the FDA as the U.S. food safety czar.

Long-Term Opioid Use Questioned at FDA Hearing

Recently, I’ve been reading and thinking a great deal about the use of prescription drugs for pain. Opioids are clearly the flashpoint for current debate.

From today’s MedPage:

Opioids used to be prescribed primarily for cancer pain and short-term relief immediately after surgery or an accident. But that changed in 1996, when the American Academy of Pain Medicine and the American Pain Society — organizations that get substantial funding from drug companies — issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low.

Since then, drugs like OxyContin and Vicodin increasingly have been used to treat a wide array of chronic pain syndromes including low back pain and fibromyalgia, despite a lack of good scientific evidence to prove that their benefits outweigh potential harm when used long term. Opioids are also increasingly being prescribed to the elderly, often for chronic pain.

The Obama administration has called the current prescription drug abuse epidemic a “public health crisis” worse than the crack and heroin epidemics of past decades. In 2007, there were 28,000 deaths from prescription drug overdoses — five times the number in 1990. Those deaths were driven largely by the abuse of prescription painkillers. Painkiller abuse now matches abuse of illegal drugs.

“[Opioids’] increasing use has resulted in a clearly unacceptable increase in addiction, overdose, and death,” Douglas Throckmorton, MD, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research, said at the meeting.

But the meeting didn’t focus on safety concerns with opioids; rather, it focused on efficacy and effectiveness, and attendees discussed the existing evidence to support giving pain patients opioids long term.