Opinion

The Great Debate

Thalidomide’s big lie overshadows corporate apology

A lie wrapped in an apology is still a lie. It is a big lie, a particularly offensive lie, coming as it does from the German company Chemie Grünenthal responsible for inflicting its notorious drug thalidomide on hundreds of thousands of women in 52 countries. Some 90,000 babies are calculated to have died in spontaneous abortion, but at least 10,000 mothers are known to have given birth to malformed babies between 1958 and 1961; the most damaged survive today as limbless trunks, others whose legs and arms were reduced to digital “flipper” extrusions from the shoulder, and thousands have severe internal injuries as well.

Grünenthal (now GmbH) was a small private company set up after World War Two as an offshoot of an old family firm that made soaps and detergents. Its first pharmaceuticals were produced under foreign license, but thalidomide (which it called Contergan) was its own, a sedative discovered by accident in the spring of 1954 by a 32-year-old chemist and doctor, Heinrich Mückter. To exploit the postwar sleeping-pill boom, Grünenthal marketed it massively from October 1957 as “completely safe,” “completely atoxic,” and free of the unpleasant side effects of barbiturates. The sales department called it “the apple of our eye” because it was so profitable. From 1958 to 1961 they zeroed in on promoting it for use by expectant mothers.

The apology for the tragedy has come from Grünenthal’s new chief executive, Harald Stock, who at the end of last month stood outside the company’s Rhineland offices in the small town of Stolberg to unveil a bronze sculpture of a thalidomide child with foreshortened “flipper” arms. “We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you, human being to human being.”

The emotion and apparent sincerity were appealing, but in the next breath he made forgiveness impossible. “Grünenthal acted,” he said, “in accordance with the state of scientific knowledge and all industry standards for testing new drugs that were relevant and acknowledged in the 1950s and 1960s.” That was flatly untrue, a product of either deep-rooted cynicism, belying his whole apology, or of appalling ignorance. Grünenthal has propagated the big lie for 50 years, retailing the notion that reproductive tests were unnecessary because nobody could possibly have realized in the fifties that a drug could penetrate the placental barrier and reach the fetus. (Stock and the company did not respond to requests for comment on these charges.)

It is 39 years since, as editor of the Sunday Times of London in the early seventies, I was associated with thalidomide investigations. Our survey of the scientific literature, consultations with reputable pharmaceutical companies and independent specialist advice swiftly found that reproductive studies were routinely done in the 1950s, because it was widely recognized that a drug could indeed reach the fetus. The tranquilizers in direct competition with thalidomide were all tested for teratogenic effects and the results published. If reproductive tests had been done on thalidomide, they would not necessarily have shown precisely what deformities would be produced, dependent on the time of ingestion in relation to the development of the fetus, but they would certainly have shown that drugs could endanger unborn children in some way.

Plan B: where politics trump science. Again.

By Amanda Marcotte
The views expressed are her own.

Wednesday morning Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s long-awaited decision taking age restrictions off Plan B emergency contraception. The change would have allowed those 16 and under to buy Plan B, moving it from behind the pharmacist counter and into the shelves alongside aspirin and condoms. But now that won’t happen.

The decision confounded the medical community as well as the women’s rights world. Since no HHS Secretary has ever overruled an FDA decision of this sort before, the widespread assumption, best articulated by Matt Langer at Wonkette, was that Sebelius was working under “marching orders from an administration now fully in re-election mode” and fearful of getting a reputation as somehow “soft” on teen sexual activity.

Sebelius admitted to no political calculation, and instead claimed to be concerned about supposedly inadequate research into the effects on 11- and 12-year-olds who might use the pill. FDA Commissioner Margaret Hamburg, no doubt irate at being told she and her entire team don’t know how to do their job as well as non-medical professional Sebelius, denounced this argument, and defended the extensive research done to assure that Plan B was safe for over-the-counter sales. Taking into account the evidence, and the drawn-out political battle over emergency contraception, it’s safe to say that Sebelius did choose political pandering over women and girls’ best interests.

Let cancer patients have this pill

CANADA-HEALTH/

One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.

Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.

If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.

Don’t demonize drug samples. They are crucial to our healthcare

AIDS DEATH RISE DESPITE CALLS FOR TREATMENTThe following is a guest post by Grace-Marie Turner, founder and president of the Galen Institute, a non-profit research organization focusing on patient-centered solutions to health reform.

Medical researchers recently confirmed a link between chronic fatigue syndrome and a recently discovered retrovirus. Armed with this knowledge, some doctors are now prescribing HIV drugs to their sickest patients.

This story highlights how difficult it is for physicians to find the right medicines for their patients. The interaction between a particular drug and the human body is incredibly complex. People react to the exact same treatment in very different ways.

Extending vaccines to the worlds poorest

Joe-Cerrell-410.jpg–Joe Cerrell is director of Global Health Policy and Advocacy at the Bill & Melinda Gates foundation. He oversees the foundation’s global health communications, public policy, and international finance. The views expressed are his own. –

I recently took my three-year-old twin daughters to their annual doctor visit, where they received their latest round of routine vaccinations.  Thanks to the miracle of vaccines, I know my daughters will be protected for life against measles, tetanus, and other diseases that were once serious threats. But incredibly, millions of children in poor countries still die from diseases that could easily be prevented with the effective, affordable vaccines that Americans take for granted.

Fortunately, that is starting to change.  This week, a landmark report from the World Health Organization, UNICEF, and the World Bank concludes that a renewed global push on childhood immunization has raised the number of children vaccinated to an all-time high.  The authors find that vaccines now save 2.5 million lives worldwide every year.

The myth of drug “re-importation”

Peter Pitts — Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. The views expressed are his own. –

On Thursday, as part of the Department of Homeland Security funding bill, the Senate voted to make us less secure by allowing Americans to purchase prescription drugs from Canada over the Internet. The measure is now headed to conference, where House and Senate lawmakers will hammer out a final piece of legislation.

When he introduced the measure to his fellow Senators, Louisiana Republican David Vitter described it as a “re-importation amendment.” And over the next few weeks, as lawmakers deliberate on this, you’re likely to hear that phrase quite a bit. Supporters of foreign drug importation believe that such wording makes this policy more palatable to the American public.

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