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Tag: food and drug administration
Story Not Over In EpiPen Scandal

Story Not Over In EpiPen Scandal

So the seller of the EpiPen is now going to offer a generic alternative costing 50 percent less. The Mylan drug company has been drowning in public outrage for jacking up the list price of an EpiPen two-pack from about $100 to as high as $600 over nine years. The EpiPen is a lifesaving injection device for people suffering a severe allergy.

Story not over, as much as Mylan would like it to be. Story not over by a long shot.

Why did the Mylan execs raise the price of an old treatment sixfold? Because they could get away with it.

Why could they get away with it? Because the United States Congress let them. The U.S. is the only advanced country that doesn’t routinely negotiate drug prices with the makers. (The Department of Veterans Affairs and Medicaid are exceptions.)

Mylan surely didn’t want this scandal leading to serious efforts in Washington to start regulating what drug companies may charge the American people. Better to stage this semi-retreat and change the subject.

Note that this is not an ordinary take-it-or-leave-it consumer product. For people severely allergic to spider bites, bee stings, nuts, eggs or shellfish, it’s take it or possibly die.

Our elected representatives have tied the American consumer down, belly up, to accept corporate abuse that other countries would not tolerate. Mylan showed its “thanks” by incorporating in the Netherlands to avoid U.S. taxes.

When the EpiPen price backlash hit full force in the U.S., the Canadian government simply reassured its citizens: Don’t worry. An EpiPen still costs only about $100 in Canada.

Mylan’s initial response to public anger was a program offering to help some patients with out-of-pocket costs. These patient-assistance deals are basically PR stunts, charitable gestures for which Americans are supposed to feel grateful.

Mylan CEO Heather Bresch tried to distinguish herself from the soulless drug industry vampires who infamously bled desperate patients, taxpayers and buyers of insurance. That would be Martin Shkreli, who hiked the price of a 62-year-old HIV drug by 5,455 percent, and J. Michael Pearson, whose Valeant Pharmaceuticals raised the price of a lifesaving heart drug 525 percent in one day. Bresch is not different, only smoother.

In an interview on CNBC about the EpiPen price hike, Bresch said, “Look, no one’s more frustrated than me.”

“But you’re the one raising the price,” the interviewer gasped. Perhaps she isn’t smoother.

Defenders of the status quo argue that competition is the ticket to lower drug prices, not a more assertive government. They blame the federal Food and Drug Administration bureaucracy for hindering would-be rivals. Some criticize the excessive monopoly rights the U.S. government grants drug companies.

They are not entirely wrong. More competition would help. But the fact remains that an EpiPen two-pack costs only about $85 in France, a fraction of the new $300 wholesale list price “deal” Mylan is now offering Americans — and it’s not because drugmakers are tripping over one another to offer competing products.

The real villain of the piece is a Congress that lets these companies prey on Americans. Congress actually forbade the government to negotiate drug prices on behalf of Medicare patients. (For the record, Bresch is the daughter of Sen. Joe Manchin.)

The injuries to American drug consumers continue piling up. Over the past 15 years, the average price of new cancer drugs in the United States has risen five- to tenfold. Cancer drugs now cost about twice as much in this country as they do in Canada.

Americans should be asking candidates for Congress whether they support government intervention against obscene drug prices. Until that happens, this disgraceful story will not be over.

Follow Froma Harrop on Twitter @FromaHarrop. She can be reached atfharrop@gmail.com. To find out more about Froma Harrop and read features by other Creators writers and cartoonists, visit the Creators webpage at www.creators.com.

Photo: EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016.  REUTERS/Jim Bourg

FDA Overturns 30-Year Ban On Blood Donations By Gay Men

FDA Overturns 30-Year Ban On Blood Donations By Gay Men

(Reuters) — The U.S. Food and Drug Administration ruled on Monday that gay men can donate blood 12 months after their last sexual contact with another man, overturning a 30-year ban aimed at preventing the transmission of HIV, the virus that causes AIDS.

The agency said people with hemophilia and related blood clotting disorders will continue to be banned from donating blood due to potential harm they could suffer from large needles. Previously they were banned due to an increased risk of transmitting HIV.

The agency said it has worked with other government agencies and considered input from outside advisory bodies, and has “carefully examined the most recent available scientific evidence to support the current policy revision.”

The agency said it has also put in place a safety monitoring system for the blood supply which it expects to provide “critical information” to help inform future FDA blood donor policies.

“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population,” Dr. Peter Marks, deputy director of the FDA’s biologics division, said in a statement.

Several countries, including the United Kingdom and Australia, have 12-month deferrals.

During the change in Australia from an indefinite blood donor deferral policy, essentially a ban, to a 12-month deferral, studies evaluating more than 8 million units of donated blood were performed using a national blood surveillance system, the FDA said.

“These published studies document no change in risk to the blood supply with use of the 12-month deferral,” the agency said. “Similar data are not available for shorter deferral intervals.”

The agency said its policies to date have helped reduce HIV transmission rates from blood transfusions from 1 in 2,500 to 1 in 1.47 million.

(Reporting by Toni Clarke in Washington; Editing by David Gregorio)

Photo: People line up to give blood at a mobile donation station set up following the shooting at Umpqua Community College in Roseburg, Oregon, United States, October 2, 2015. Chris Harper-Mercer, the man killed by police on Thursday after he fatally shot nine people at the southern Oregon community college was a shy, awkward 26-year-old fascinated with shootings, according to neighbors, a person who knew him, news reports and his own social media postings. REUTERS/Lucy Nicholson

Nearly Half Of Americans Subscribe To A Medical Conspiracy Theory, Survey Finds

Nearly Half Of Americans Subscribe To A Medical Conspiracy Theory, Survey Finds

By Melissa Healy, Los Angeles Times

Is there really a link between vaccine and autism, cellphones and cancer, HIV and the CIA? Almost half of Americans believe the answer is yes for at least one of the many medical conspiracy theories that have circulated in recent years. And the attitudes and behavior of those conspiracists toward standard medical advice reflect that mistrust, says a study out this week.

A pair of University of Chicago social scientists set out to determine the extent of “medical conspiracism” among the U.S. public and conducted a nationally representative online survey of 1,351 adults. They gauged knowledge of and beliefs about six widely discussed medical conspiracy theories and explored how belief in those theories influenced individuals’ behavior when it came to matters of health.

Their results appeared as a letter published online this week in the journal JAMA Internal Medicine.

Fully 37 percent of those surveyed endorsed the belief that the Food and Drug Administration, under pressure from pharmaceutical companies, is suppressing natural cures for cancer and other diseases, and 31 percent said they “neither agree nor disagree” with that idea, the researchers found.

One in five of those surveyed said they agreed that physicians and the government “still want to vaccinate children even though they know these vaccines cause autism and other psychological disorders.” And 36 percent were on the fence, saying they neither agreed nor disagreed that there may be truth in the much-studied and widely discredited contention that vaccines cause autism.

Similarly, 20 percent said they believed that cellphones had been found to cause cancer but that the government had bowed to large corporations and would do nothing to address the health hazard. Though 40 percent disagreed, the remaining 40 percent withheld judgment on the idea that the government has been silenced about a known link between cellphones and cancer.

Less-widely recognized medical conspiracy theories concerned genetically modified foods, HIV and water fluoridation, and they were not without adherents.

Just 12 percent of respondents said they agreed with a widely discussed theory that genetically modified foods have been widely disseminated by Monsanto Inc. as part of a secret program called Agenda 21, launched by the Ford Foundation and the Rockefeller Foundation to shrink the world’s population. While 42 percent disagreed, 46 percent stayed on the fence.

Just over half of Americans rejected outright a widely circulated theory alleging that the CIA deliberately infected African-Americans with the HIV virus under the guise of a hepatitis inoculation program. But 12 percent agreed, and 37 percent said they neither agreed nor disagreed.

The authors of the letter, J. Eric Oliver and Thomas Weed, said the conspiracy believers spanned the political spectrum and tended to espouse conspiracy theories outside of medicine as well. But they found that the more conspiracy theories a person endorsed, the more likely he or she was to take vitamins and herbal supplements and buy mostly organic food, and the less likely he or she was to get an annual physical, wear sunscreen, visit a dentist or get a flu shot.

Given that medical conspiracy theories are so widely known and embraced, said Oliver and Weed, it would be unwise to dismiss all those who believe them as a “delusional fringe of paranoid cranks.” Instead, they suggested, “we can recognize that most individuals who endorse these narratives are otherwise normal” but use a sort of cognitive shortcut to explain complex and confusing events. Physicians can also glean a bit more about their patients — and their readiness to accept medical counsel — when they know that a conspiracy adherent has come for the occasional doctor visit.

AFP Photo/Spencer Platt