Prescribing Antipsychotic Drugs to Kids

Consumer Reports looks at current practices and finds them alarming:

The number of children taking powerful antipsychotic drugs has nearly tripled over the last 10 to 15 years, according to recent research. The increase comes not because of an epidemic of schizophrenia or other forms of serious mental illness in children, but because doctors are increasingly prescribing the drugs to treat behavior problems, a use not approved by the Food and Drug Administration (FDA). And a disproportionate number of those prescriptions are written for poor and minority children, some as young as age 2.

Doctors are prescribing antipsychotics even though there’s minimal evidence that the drugs help kids for approved uses, much less the unapproved ones, such as behavioral problems. And to make matters worse, the little research there is suggests the drugs can cause troubling side effects, including weight gain, high cholesterol, and an increased risk of type-2 diabetes.

This pattern repeats itself throughout the medical system. A drug that may be helpful for certain severe cases is prescribed for vastly greater numbers of people. As we move down the severity scale, the risk-benefit ratio gets worse and worse. Milder cases (even assuming the diagnosis is correct) are those least likely to benefit from drug treatment and most likely to have a cost-benefit ratio that’s underwater.

New Cholesterol Calculator Tells Healthy People They Need Statins

The cholesterol guidelines released last week are already poised to drastically increase the number of people prescribed statin drugs, and this calculator that the American College of Cardiology just unveiled will help people miscalculate their risk (substantially upwards, of course) even more.

This is beyond the beyond. Worth reading this whole article if you or a loved one are considering taking statins.

“[It] overpredicted risk by 75-150%, depending on the population. A man whose risk was 4 percent, for example, might show up as having an 8 percent risk. With a 4 percent risk, he would not warrant treatment…..  Miscalibration to this extent should be reconciled and addressed before these new prediction models are widely implemented. If real, such systematic overestimation of risk will lead to considerable overprescription.”

“Something is terribly wrong,” Dr. Nissen said. Using the calculator’s results, he said, “your average healthy Joe gets treated, virtually every African-American man over 65 gets treated.”…

Supreme Court Rules That Human Genes Cannot Be Patented

This may be best Supreme Court decision in recent years. Human genes may not be patented. Those that have patents on genes no longer have them.

I confess to some surprise at this decision. But my main emotion is elation.

The decision was unanimous.

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for a unanimous court. But manipulating a gene to create something not found in nature is an invention eligible for patent protection.

The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.

The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.

The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated.

The court’s ruling will shape the course of scientific research and medical testing, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.

40% Failure Rate on Hip Transplants: Executives Knew But Hid the Evidence

This level of corruption in the service of corporate profits is no surprise to anyone who follows developments in the drug and medical device industries. Still, if I step back a bit, it is nothing short of breathtaking.

THIS month, Johnson & Johnson is facing more than 10,000 lawsuits over an artificial hip that has been recalled because of a 40 percent failure rate within five years. Mistakes happen in medicine, but internal documents showed that executives had known of flaws with the device for some time, but had failed to make them public.

It would be nice to imagine that this kind of behavior is exceptional, but in reality, the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good. These problems would be bad enough on their own, but they are compounded by a generation of “fake fixes” that have delivered false reassurance, and so prevent realistic public discussion.

The best evidence shows that half of all the clinical trials ever conducted and completed on the treatments in use today have never been published in academic journals. Trials with positive or flattering results, unsurprisingly, are about twice as likely to be published — and this is true for both academic research and industry studies.

Read the rest of the article. It actually gets worse.

 

 

Supreme Court Accepts Gene Patenting Case

In the long run, this case may have greater influence than many of the higher profile cases on which the Court decides.

The U.S. Supreme Court on Friday agreed to decide whether human genes can be patented, a hotly contested issue with broad practical and ethical consequences for the future of gene-based medicine for millions of people worldwide.

The nation’s highest court in a brief order agreed to review a case over whether Myriad Genetics Inc may patent two genes linked to hereditary breast and ovarian cancer.

In a 2-1 ruling on Aug. 16, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld the biotechnology company’s right to patent “isolated” genes that account for most inherited forms of the two cancers.

That ruling also denied Myriad’s effort to patent methods of “comparing” or “analyzing” DNA sequences.

The appeal against Myriad and the University of Utah Research Foundation was being pursued by a variety of medical associations and doctors, led by the Association for Molecular Pathology. Their case is being handled by lawyers for the American Civil Liberties Union.

There are many issues at play here. Consider this one: gene patents like these held by Myriad can be used (and are used) to deny researchers the right to conduct research related to the patented genes (i.e., breast cancer research) unless they pay the patent holder whatever fee the corporation wishes to charge.

From both ethical and economic perspectives, this is a most controversial topic. I hope the Court decides that genes are the common heritage of all humanity and are not patentable under any circumstances.

Preventing Unintended Pregnancies and Abortions Through No Cost Contraception

Research evidence confirms beneficial effects of Obamacare’s contraception mandate.

Here’s the abstract of the article from Obstetrics and Gynecology, along with news and commentary from Think Progress Health:

A new study focusing on low-income women in St. Louis, MO concludes that expanding access to free contraception — just as the health care reform law does through its provision to provide birth control without a co-pay — leads to significantly lower rates of unintended teen pregnancy and abortion. Researchers found that when women weren’t prohibited by cost, they chose more effective, long-lasting forms of birth controland experienced much fewer unintended pregnancies as a result.

Researchers from the Washington University School of Medicine in St. Louis worked in partnership with the local Planned Parenthood affiliate to track over 9,200 low-income women in the St. Louis area, some of whom lacked insurance coverage, during a four-year Contraceptive CHOICE study. The CHOICE project simulated Obamacare’s birth control provision by allowing teens and women to select from the full range of FDA-approved contraceptive options and receive their preferred method at no cost. They found that birth rates among the teens who received free birth control in the CHOICE project were less than a fifth of the national teen birth rate — just 6.3 births per 1,000 teens, compared to 34.3 per 1,000 teens nationwide in 2010 — and abortion rates were less than half of both the regional and national rates.

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.