Dolly on the Dinner Table? Don't Worry About It

Art Caplan writes in his MSNBC column:

Dolly, the world's first cloned mammal, must be turning in her grave.

The Food and Drug Administration has declared that meat and milk from cloned animals is safe to eat, paving the way for cloned products to show up in grocery stores across the land, likely without any special labels or warnings. This makes sense because there is absolutely no evidence to show that there is anything unsafe about milk or meat from cloned cows, goats or pigs. (Actually, the FDA is holding off on deciding whether cloned sheep are a safe source of chops, saying not enough information is available yet.) But many of us hear the words "meat from cloned animals" and get queasy. Dolly, fairly or not, is to blame.

Dolly was a sweet-faced little sheep who bothered no one during her life. Her only impact on humanity was to give employment to countless novelists, journalists, TV producers, cult leaders, Hollywood screenwriters, politicians, comedians and, yes, bioethicists, who otherwise might have spent years wondering what they could do that would scare the daylights out of the American public while making either making them plenty of money or getting them elected in the case of the politicians. Remember Osama bin Laden and avian flu weren't in the news when Dolly's existence was announced to a completely freaked-out public in 1997.

Dolly, whose remains are on display at the Royal Museum of Scotland, spent her six years on earth as the object of scorn, fear, derision and slander. The media had a field day upon her birth telling us that Dolly was the key to resurrecting the dead, creating vicious clone armies and a world in which everyone would be trailed by a hapless clone whose internal organs would be available on demand to prolong lives threatened by disease or old age. Who could like a cloned animal when the technology that created her might lead to innumerable copies of Kevin Federline, Bob Saget or Nicole Richie?

But worse was to follow. Soon wacky cults like the Raelians and nutty scientists and semi-scientists like the incredibly fortuitously named Dr. Richard Seed and the ominously monikered Professor Panos Zavos were hollering about cloning rich people, cult leaders, and generally unsavory types to the rapt and stupefied attention of a media unable to discern the fact that dressing in a Star Trek uniform and displaying a very bad hair dye job did not prove your bona fides as the cloner most to be feared.

All of this nonsense set the stage for the next big scare about cloning, which was fueled by the debate over federal funding for embryonic stem cell research. Opponents of that funding found they got the greatest traction for their desire not to see federal funds spent by invoking the word "clone" over and over again. Funding embryonic stem cell research likely meant a pod person would move in next door, some high-profile Republican legislators as well as President Bush would lead you to believe.

All of this nonsense took a toll. It made Americans forget that cloning is nothing more than artificially creating twins. It made us forget that every drop of wine we drink comes from cloned grapes. It made us ignore the fact that if you want to worry about what you are eating you would be better off fretting over whether the FDA has enough inspectors on the job at meat plants looking for salmonella and E. coli than whether your dinner started off as a clone. Dolly got a bad rap. And it has stuck. But the FDA is right to follow the evidence and let products from clones enter the marketplace.

If people want these products labeled so they can choose not to buy them, that's their right. But, before you decide, remember the only thing you really have to fear from cloned animals is what human beings have done to ruin their reputations!

-Art Caplan

The Agony and the Ecstasy

Rick Weiss of the Washington Post reports today that the FDA has approved a proposal to test the illegal street drug "Ecstasy" for treatment of severe anxiety in terminally ill patients. Ecstasy, also known as MDMA or 3,4-methylenedioxymethamphetamine, is currently being tested for its ability to reduce symptoms of post-traumatic stress disorder. Psychiatrists refer to the drug as an "empathogen" helping to put people in touch with their emotions. Researchers at Harvard, who obtained permission from ethics review boards at Harvard and Lahey Clinic, to submit this proposal, believe that this drug could contribute significantly to the range of palliative care strategies available to patients who must face the emotional challenge of the end of their lives.[Link] - Linda Glenn.

The FDA's Darkest Days Are Here

FDA Is Flexing Less Muscle, write Marc Kaufman and Brooke Masters in this major page one story on the FDA. The gist:

In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health.

Today the New York Times joins in the page one coverage

:Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at." In testimony before the Senate Finance Committee, Dr. David Graham, the reviewer in the Food and Drug Administration's office of safety research, used fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers.

RU-486 Suspension

Is it coming?

Merck and Ethics

Raymond Gilmartin, CEO of Merck, spoke at Michigan. Gilmartin took the occasion to defend the timing of his company's decisions about Vioxx.

He said that although some Merck insiders urged him to inform the FDA of the findings and keep Vioxx on the market, he acted decisively, withdrawing the drug within a week.

The Merck CEO reserved his most enthusiastic comments for his corporate bioethics efforts:

After taking the reins in 1994, Gilmartin said within a year he had established the company’s first ethics office. He said Merck had established numerous ethics systems during his tenure — including a confidential phone number employees can call for advice concerning their ethical dilemmas.

Merck’s commitment to ethical behavior goes beyond complying with U.S. and international laws, he said. “As Plato put it, good people do not need laws to tell them how to behave responsibly; bad people always find a way around the laws.”

Gilmartin said Merck’s code of ethics is displayed in 25 different languages at company headquarters in Trenton, New Jersey. “Over time, ethical behavior turns into a competitive advantage,” he said.

Merck's CEO did well by Michigan business students: "The capacity audience, mostly Business School students, treated Gilmartin to a loud and spirited ovation after he concluded remarks."

w-2: Searching for Good News in a Bush Victory

It is difficult to overstate the damage that George Bush can do to the nation's health care and biomedical science in his second term. Long after the shock of a Bush victory - yes, he did win this time - has faded in the minds of Americans, the world will have to cope with this election. What are the implications for medicine and science? Hint: you won't like any of them ... this term, Bush is empowered, under pressure from conservative protestants, and a lame duck to boot.

Kiss pharmaceutical reform goodbye. There is no way George Bush will do any less for pharmaceutical companies than he has done for oil companies. In fact, if anything, the election will draw a more direct analogy between oil and drugs: Bush now has no reason to fear reprisals from those who oppose the drug industry's extraordinary pricing structure in the United States. Bush's cronies may not yet directly profit from the drug industry in the way that they do from Haliburton, but you can bet plenty of Bush appointees are thinking seriously about their future in biomedical lobbying. Pharma will need the President as its collusion with FDA officians and others comes to the fore. Pharma knew what it was buying with Bush, "make no mistake." Any reform effort that included drugs from Canada, including the one Bush said he was "looking at," and any effort to seriously curtail the price of drugs for seniors, will fall prey to the three million vote margin of victory. Drugs will cost more and fewer people will be able to afford them.

International efforts to, well, do anything that Bush opposes are in real trouble. Unfettered international drug research is part of the bargain. Advocates for research subjects have lobbied the WHO and the UN - and those organizations have lobbied the US - to stop the most lopsided and colonialist drug industry research efforts in developing nations. How many research programs in Africa have really rewarded research subjects with any kind of improvement in healthcare quality, even for the disease being researched? Not many.

Healthcare access and insurance reform? Look, no one wants to be pessimistic. Health insurance reform is long-overdue and we in the U.S. have to find a way to provide affordable healthcare to tens of millions of U.S. uninsured. Here's a great Bush solution that lots of Americans seem to support: tort reform! All we have to do is stop those big lawsuits against physicians, and we can save a whole lot of ... wait ... what? Only 3% of the cost of healthcare is in any way related to lawsuits? Ok, wait, so maybe stopping patients from recovering the damages juries want to award them in cases of malpractice won't have much financial effect ... except on physician and lawyer salaries. But Republican voters aren't weeping about that. What they will cry about is the bills that they, and all of us, will have to pay as we watch emergency rooms continue to be the provider of healthcare for the poor, the sick and the legions of uninsured - hundreds of millions of dollars in unnecessary treatment. Those costs have to come out of somewhere. Just watch your premiums skyrocket, guys. Red states will also bleed red ... ink. Maybe there will be a direct correlation between insurance increases and prices at the gas pump! Who knew anything but college tuition could go up so fast?<[> Enough has been written about Bush's war on science to establish beyond question in the mind of anyone in a blue state that Bush, as a final-term president with uniform control of the U.S. government, will be able to quietly support all sorts of insidious efforts around the nation. Just as gay marriage is quietly being outlawed around the nation, look for Bush to lend support of several kinds to state efforts to roll back protection of women's reproductive healthcare. Bush could care less about evolution, but the "intelligent design" movement can rest easy that Oklahoma's new senator and many other new elected officials around the nation are supporters of creationism in the classroom.

There is still one winable battle, although I fear it is not in Ohio or Iowa. The battle is to reform or reject the President's Council on Bioethics. Leon Kass is no doubt gearing up to lead all the President's ethicists for another term of 'moral seriousness'. He must be put on notice that bioethics cannot afford four more years of feckless, xenophobic neocon posturing, even if it is delivered with austerity. Kass should have apologized to the nation for selling the proceedings of his Council through a for-profit, conservative commercial press. He should not have abused the reputation of one of the world's most prestigious biomedical scientists, Elizabeth Blackburn, named by Bush to the PCB and then shown the door under the pretense that she did not attend enough meetings. Blackburn was by all accounts one of the most active participants in the dialog about stem cell research, emailing Kass and others constantly. Kass could not find another way to defend the PCB against the charge that it sat idly by while the Bush administration (or he) fired one of two moderate scholars, and "retired" the other one, replacing both with ultraconservatives. So Kass resorted to distortion and blame in broad public view. To this day he has neither apologized nor attempted any kind of rapprochement with Blackburn or for that matter with anyone more moderate than William Kristol.

The new generation of conservative bioethicists seems dedicated to the proposition that debate is the enemy, or more accurately that opponents are best left ignored. The PCB virtually ignores the bioethics literature in its writing and anthologies. There are passing references to those who agree with them on matters at hand, most noticeably Carl Elliott, but it has become a hallmark of Bush Bioethics that no position is argued by the PCB while there are people 'in the room' with whom one must argue, unless absolutely necessary. This Council must go, or at least be made to play a peripheral role in the bioethics scene, unless it is radically remade with voices from both sides of the aisle. Supposedly even Wesley Smith agrees that there should be such voices. Now it is time for the American Enterprise Institute's Hertog Fellow Leon Kass to act with courage so that we really can have a "richer" bioethics.

It is a pretty terrible day for those of us in bioethics who supported the right to choose, hES research, and dozens of other areas I have not taken the space to discuss. But the real tragedy would be if bioethics did not take from this mess the lesson that not all battles must be fought nationally. State-by-state we will see the new changes made in bioethics-relevant law. California's Proposition 71 is just the beginning of some very important new shifts that deserve some real pragmatic consideration. Bioethics may not be as prestigious when it is fought out in the states, but that is where the battles now lie, at least for four more years. - Glenn McGee (UPDATED 11/3;11/20 )

Did the FDA Work Against Revealing Vioxx Findings?

Washington Post quotes an FDA official, David Graham, who indicates that in fact he was told to "water down" the report on the hazards of Vioxx.

Genentech Subpoena over Rituxan

Genentech has been asked to turn over marketing materials for its cancer drug Rituxan in an event that may signal increasing FDA crackdown of off label marketing. Regardless of the outcome in this particular case, off label drug use raises several interesting ethical issues. This is discussed in this piece in Red Herring. - David Magnus

UPDATE: NYT on Cloning and First Amendment

Brian Alexander, one of the best of the "bioethics essayists" to emerge in the past five years, helps the Times' Magazine make a first foray by a newspaper into one of the more interesting questions concerning current and pending laws governing both cloning and embryo research: could they survive an appellate court review? Is it unconstitutional (or wrong) to restrict scientific experimentation on the grounds that such a restriction violates freedom of expression? Brian quotes Robertson, Kass and Sunstein on the analogy between experimentation and reporting. Brian tells us the Times' editors cut his interview with Lori Andrews on her great work on the specific issue of the constitutionality of cloning per se. I wondered about why the piece didn't mention the important FDA policy prohibiting cloning that aims at gestation; Brian says the editors cut that too.