Breaking News

LOS ANGELES – The fertility doctor who helped a California woman have 14 children, including octuplets born last month, is now facing a state investigation on top of harsh criticism from medical ethicists.

The Medical Board of California did not identify the doctor who helped Nadya Suleman, 33, of Whittier, become pregnant with the six boys and two girls born on Jan. 26. Suleman has six other children.  “We’re looking into the matter to see if we can substantiate if there was a violation of the standard of care,” board spokeswoman Candis Cohen said Friday. She did not elaborate.

Suleman, a divorced single mother, told NBC’s “Today” show that the same fertility specialist provided in vitro fertilization for all 14 children using sperm donated by a friend.

In the interview broadcast Friday, Suleman also said six embryos were implanted for each of her pregnancies. In her latest, two of Suleman’s embryos split, resulting in two sets of twins among the octuplets.

When asked why so many embryos were implanted, Suleman said: “Those are my children, and that’s what was available and I used them. So, I took a risk. It’s a gamble. It always is.”

In the United States, there is no law dictating the number of embryos that can be placed in a mother’s womb. Doctors say the norm is to implant two or three embryos, at most, in women Suleman’s age.

“The revelation about one center treating her makes the treatment even harder to understand,” said Arthur Caplan, bioethics chairman at the University of Pennsylvania. “They went ahead when she had six kids, knowing that she was a single mom … and put embryos into her anyway.”

Suleman’s infants were born prematurely and are expected to remain in the hospital for several more weeks. Her six other children are between ages 2 and 7.

Suleman said she had never been on welfare and would find a way to get by with the help of family, friends and her church. She said she planned to return to school in the fall.

The births have raised questions about how the woman will be able to care for all of her children. Los Angeles County child welfare spokesman Stu Riskin said the agency doesn’t respond unless there has been a complaint, and such complaints are confidential.

“All I wanted was children. I wanted to be a mom. That’s all I ever wanted in my life,” Suleman said in the portion of the interview that aired Friday. “I love my children.”

She said she struggled for seven years before finally giving birth to her first child.

According to state documents, Suleman told a doctor she had three miscarriages. Another doctor disputed that number, saying she had two ectopic pregnancies, a dangerous condition in which a fertilized egg implants somewhere other than in the uterus.

The state documents describe Suleman becoming pregnant with her first child after a 1999 injury during a riot at a state mental hospital where she worked. Suleman feared she would lose the child and sunk into an intense depression, according to a psychological evaluation in her workers’ compensation case.

“When you have a history of miscarriages, you think it will take a miracle,” she told Dr. Dennis Nehamen. “I just wanted to die. I suspected I was pregnant but I thought, ‘That’s ridiculous.’”

But the 2001 birth of the baby “helped my spirits,” Suleman said.

More than 300 pages of documents were disclosed to The Associated Press following a public records request to the state Division of Workers’ Compensation. Among other things, they reveal that Suleman collected more than $165,000 in disability payments between 2002 and 2008 for the work injury, which she said left her in near-constant pain and helped end her marriage.

Woman, still unidentified, can wink, smell, eat solid food on her own

The severely disfigured woman who received the nation’s first face transplant left the hospital in Cleveland Thursday night, able to eat solid food and breathe on her own for the first time in several years.

“I’m happy about myself,” she told her doctors.

“She accepted her new face,” said Dr. Maria Siemionow, the Cleveland Clinic reconstructive surgeon who led the operation in early December.  Hospital officials would not say where the patient went. She and her family have declined requests for comment, and her identity has not been revealed.

The woman suffered a traumatic injury several years ago that left her with no nose, palate, or way to eat or breathe normally. In a 22-hour procedure, 80 percent of her face was replaced with bone, muscles, nerves, skin and blood vessels from a dead donor.

It was the fourth partial face transplant in the world, though the others were not as extensive.

Her recovery has been astonishing, Siemionow said. She shows no signs of rejecting her new face and can breathe normally instead of through a hole in her windpipe. A couple weeks ago, she ate pizza for the first time in years.

“She can actually feel the new face, and she does not feel the difference between her old face and her new face,” Siemionow said.

“Before surgery, she couldn’t smell at all,” the surgeon said. Now, “she can recognize perfumes, she can eat and smell her hamburger … she can drink her coffee from the cup.”

Most surprising to doctors, who thought a transplanted face would never be able to do this: “She can wink her eye,” Siemionow said.

She likely even could go out in public and not be recognized as a face transplant recipient, because her face appears fairly normal other than a little swollen, Siemionow said. “The scars are nicely hidden because it’s such a large transplant,” she said. The woman must return a couple of times a week for follow-up care.

WASHINGTON (CNN) — The House is expected to meet Wednesday and pass a bill that will expand healthcare to an estimated 4 million additional children. President Obama has made it clear he wants to sign the children’s health bill quickly.

President Obama has made it clear he wants to sign the children’s health bill quickly. The State Childrens Health Insurance Program has already passed the Senate. Lawmakers in the House have said they too will approve the bill and send it to President Obama for his signature.

Obama has made clear that he wants to sign the bill quickly, calling it a bipartisan legislative success, at a time when his economic stimulus bill is triggering a partisan divide.

“As the worsening economy causes families to lose their jobs and health insurance, it is vital that we redouble our efforts to ensure that every child in America has access to affordable health care,” the president said in a statement on Friday.

The vote in the Senate was 66-32. All those voting against the bill were Republicans, but nine Republicans voted in favor.

The bill, known as SCHIP, covers more than 6 million children whose parents earn too much to qualify for Medicaid — the federal health insurance program for the poor — but who can’t afford private insurance.

The bill expands SCHIP by more than $32 billion over five years.

The bill’s supporters say it would extend the program to an estimated 4 million additional children, paying for it with a 61-cent-per-pack increase in the federal tax on cigarettes.

Opponents argued that, among other things, it will allow undocumented immigrants to illegally access taxpayer-financed health care, and is insufficiently funded.

President Bush vetoed two similar bills in 2007, arguing at the time that the legislation would have encouraged families to leave the private insurance market for the federally funded, state-run program.

Source

How much longer will you be able to see advertisements where people blissfully run through a field after taking some kind of anti-allergy medication? Or where a down-and-out man is suddenly sunny after being prescribed an anti-depressant? How much longer will you be giggling at that commercial that warns if a certain condition lasts more than four hours, you should call a doctor?

These are questions that keep drug companies, as well as the television stations and magazines that subsist on their ad dollars, up at night (Ambien, anyone?). Direct to consumer (DTC) advertising by pharmaceutical companies has always been somewhat controversial. The U.S is one of only two countries that permit it (New Zealand is the other). Critics claim that these advertisements encourage consumers to seek out more expensive brand-name drugs from their doctors. Their symptoms might not require such medication, and when they do, cheaper generic drugs may be available. The marketing probably drives up overall health care costs. More importantly, new drugs that are aggressively marketed can pose a safety risk. Merck’s heavy promotion of pain reliever Vioxx — look at Dorothy Hamill skating without any strain! — is the prime example of advertising gone awry. The drug was later taken off the market, after it was found to increase heart attack risk.

So with a new President who has vowed to fight big pharma to lower drug costs, and a Democratic Congress that features several anti-DTC advocates, the drug and media companies are justifiably jittery. “We are entering an environment that is going to be more open to those who are adamantly opposed to direct-to-consumer advertising,” says Jay Bolling, president of Roska Healthcare Advertising in Montgomery, Pa.

However, perhaps the companies shouldn’t freak out — yet. The DTC issue has not been floated as an early White House priority, and is unlikely to be dealt with until weeks or months after Obama names an FDA nominee, an announcement that could come within days. Plus, some of DTC’s most vocal critics in Congress aren t calling for an all-out advertising ban. For example Democratic Rep. Bart Stupak of Michigan, chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, wants a moratorium on DTC ads during a drug’s first two years on the market. “Two years will give the FDA and doctors time to see what safety issues arise once a drug is approved,” Stupak says. “It will also allow adequate time to educate doctors on how to use the new drug.”

The true power player in the full House Energy and Commerce Committee, chairman Henry Waxman of California, differs from Stupak one key point. Yes, he also supports a two-year DTC moratorium for new drugs. “Americans must face an inconvenient truth about drug safety,” he says. “The truth is that we inevitably allow drugs on the market whose risks are not fully known.” Waxman, however, insists that the FDA should have the discretion to make exceptions to the moratorium. This policy follows a recommendation that the Institute of Medicine offered in a 2006 report, The Future of Drug Safety. “It doesn’t have to be a full two years,” Waxman says. “It’s allowed to be limited to drugs that the FDA thinks might be a safety problem.” Big Pharma certainly appreciates this less aggressive approach.

A two-year ban on new drug marketing could surely hurt the bottom line of the drug companies. But it wouldn’t be devastating. “I don’t think it will have a particularly big impact,” says Eric Schmidt, equity analyst at Cowen and Company, an investment bank. “The companies have already started scaling back their marketing budgets, and they’ve tended to direct advertising into more established brands.” According to Jon Swallen, a research analyst at TNS Media Intelligence, pharmaceutical companies will have spent about $4.7 billion in magazine and television advertising for 2008, a 10.7% drop from 2007. Only about 15% of DTC ads are for drugs that are less than a year old.

Further, while a two-year delay doesn’t exactly help struggling media outlets desperate for ad revenue, it shouldn’t put them out of business. Swallen figures that if the pharmaceutical moratorium were in place for last year, magazines as a group would have lost roughly $210 million, or .8%, of the approximately $25 billion in total ad revenue it took in for 2008. And that’s under a worse case scenario where the FDA keeps all new drugs out of the ad market for two years. Similarly, under worst-case circumstances, television outlets would have lost some $423 million, or 0.7%, of the $60 billion in total TV-advertising revenue if there were a moratorium on new drug advertising.

Plus, Swallen notes that these losses would only last during the initial two-year period that the ban is in place. Over that time, new drugs will still receive FDA approval, and consumer advertising can begin once the moratorium is over. “The line would be frozen behind the gate for two years,” Swallen says. “But the number of brands waiting in line will grow, and there will be the same flow into the market once the gate reopens. It’s a one-time deferral.”

Any forced delay would also certainly endure a First Amendment challenge. “In free speech areas, government management of speech, even if it’s commercial speech, should always be the last resort,” says Billy Tauzin, a former Republican Congressman from who Louisiana who now runs the Pharmaceutical Research and Manufacturers of America, the industry’s trade association. Banning tobacco ads is one thing — cigarettes can kill you. But these are prescription drugs we’re talking about. They at least have the potential to save you, right?

Waxman takes a harder stance. “I think the First Amendment is not an absolute guarantee to say whatever [we want] under any circumstances,” he says. “We often prevent free speech when it can do harm — such as yelling “fire” in a crowded theater . . . I think there’s a balancing. A very limited restriction on the First Amendment right to advertise drugs, if there is such a right, is reasonable for the public safety.”

While those tied to the drug industry may disagree, they can take solace in more positive news: Waxman won’t police DTC any time soon. “We’ve got the stimulus bill with a number of important provisions, and I’d like to get onto the big issue, which is universal health care in this country,” says Waxman. “And while we’ve got to be paying a lot of attention to the FDA in a number of respects, I think the food safety issue is a lot more important than this one at the moment. So it’s just not the highest item on my agenda.”

The companies should enjoy this calm, because it likely won’t last. The Democrats will get around to the drug companies at some point. And if Congress pushes through a two-year ban, could that set the precedent for even further DTC restrictions down the road? Are the drug and media companies headed down a slippery slope with Congress? “Give them an inch, they’ll take a mile — there’ s concern about that,” Bolling says. “There’ s no question, the Congressmen will take it as far as they can. This is platform for them. This is, “I am here to save the American public from these big, bad pharmaceutical companies.’” (Waxman says he does not support a full DTC ban.)

On top of this pressure lies the Obama wild card. The President has said he wants Medicare to negotiate drug prices directly with the drug companies, instead of through the managed care providers. What if the federal government reduced its Medicare reimbursements to drug companies who were advertising to consumers? Or required them to help fund some kind of public health or education initiative? “The pharmaceutical companies are most nervous about a financial requirement for those who are doing DTC advertising,” Bolling says. “It would have companies over a barrel. That’s where it’s really going to hurt.” Things may be quiet on the drug front right now. But with a new Democratic president and Congress in place, Big Pharma should stock up on the painkillers.

Source