Diana Zuckerman, PhD, CNN Tonight: December 18, 2009

The following is the transcript from the segment.

LOUISE SCHIAVONE, CNN CORRESPONDENT (voice-over): A bipartisan effort in the Senate this week to open the nation’s doors to pharmaceutical imports seem to be on track with this campaign trail rallying cry from then candidate Barack Obama.

OBAMA: Then we’ll tell the pharmaceutical companies thanks, but no thanks for overpriced drugs.

(APPLAUSE)

OBAMA: Drugs that cost twice as much here as they do in Europe and Canada and Mexico. We’ll let Medicare negotiate for lower prices. We’ll allow the safe re-importation of low cost drugs from countries like Canada.

SCHIAVONE: A little more than a year after that campaign stop in Newport News, Virginia, the head of President Obama’s Food and Drug Administration urged a no vote on a drug imports bill proposed by North Dakota Senate Democrat Byron Dorgan. Commissioner Margaret Hamburg raising “significant safety concerns” and calling the measure “logistically challenging to implement and resource intensive.” Former Democratic congressional staffer David Sirota, now a left of center political analyst, says the Dorgan amendment would’ve achieved the goals of candidate Obama.

DAVID SIROTA, AUTHOR: Many of the drugs that people consume at their pharmacy right now are made not in this country. What this bill merely would have done would allow wholesalers and pharmacists to buy those drugs at the international world market price, a lower price than they’re being sold here. SCHIAVONE: The Dorgan proposal, with some Republican backing would’ve permitted licensed U.S. pharmacies and drug wholesalers to import FDA approved drugs from Canada, Europe, Australia, New Zealand, Switzerland and Japan, passing along the savings to consumers, savings which Dorgan says could have been in the tens of billions of dollars over the next 10 years. Those savings are no small matter to the National Research Center for Women and Families.

DIANA ZUCKERMAN, NATL. RESEARCH CENTER FOR WOMEN AND FAMILIES: We were hoping that the time had come when the American public and our public health would be the first priority, not the interests of drug companies. And that’s the biggest disappointment –that the drug companies — their lobbyists — as usual have had their say much more so than they deserve.

SCHIAVONE: The Center for Responsive Politics finds that from 1998 to the present, the pharmaceuticals and health products business was the top spending lobby, investing more than $1.7 billion. The industry leads the pack this year with expenditures so far listed at nearly $200 million. Pharma, the pharmaceutical lobby’s main voice offered no apologies telling CNN “the Dorgan amendment was defeated because common sense people recognize there is no way to guarantee the safety and efficacy of medicines brought into the United States outside of the FDA’s control.”

(END VIDEOTAPE)

Susan Heavey, Reuters: September 23, 2009

WASHINGTON (Reuters) – The U.S. Food and Drug Administration took its first steps to rein in the tobacco industry on Tuesday, implementing a ban on candy, clove and other flavored cigarettes.

The move, required by a law passed earlier this year giving the FDA greater power over tobacco products, aims to help prevent children and teenagers from smoking.

“Candy and fruit flavored cigarettes are a gateway for many children and young adults to become regular tobacco users,” Dr. Lawrence Deyton, head of the FDA’s Center for Tobacco Products, told reporters in a conference call.

In June, President Barack Obama signed legislation allowing the FDA to oversee the manufacturing and marketing of cigarettes and other tobacco products, including regulating ingredients and limiting advertising. The agency must also approve any new tobacco products.

Still, the bill excludes any immediate action on menthol, or mint, flavored cigarettes that are used by as many as 12 million Americans, including most African-American smokers. Lawmakers instead called on the FDA to study the issue.

It is not immediately clear how effective the ban will be or what impact it will have on smoking habits.

“Although it will take time for it to have a 100 percent effect … it will have a dramatic effect on children and young women who are most likely to smoke these products,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Children who already smoke may switch to regular cigarettes, but many will be reluctant try smoking if products don’t taste good, she said. “I think it does make it harder for companies to try to get away with anything,” she added.

The ban in unlikely to affect U.S. tobacco companies such as Altria Group Inc’s Philip Morris unit and Lorillard Inc’s Lorillard Tobacco Co, which do not make flavored cigarettes.

But some advocates have already expressed concern that smaller companies will simply shift their attention to cigars, snuff and other tobacco products not covered by Tuesday’s ban.

The Campaign for Tobacco-Free Kids, which supported the FDA’s new oversight, said the nation’s top distributor of clove-flavored cigarettes, California-based Kretek International Inc., now sells clove cigars that look and taste like its clove cigarettes.

Representatives for Kretek, which imports most of its products, could not be immediately reached. Star Scientific and other companies also make dissolvable smokeless tobacco products in various flavors.

FDA’s Deyton said the agency would discuss other flavored products.

The FDA posted information about the ban on its website here

(Editing by Steve Orlofsky)

Marie McCullough, Philadelphia Inquirer: September 10, 2009

Government advisers yesterday recommended federal approval of Cervarix, the GlaxoSmithKline cervical cancer vaccine, after reviewing studies showing it is significantly more effective than Gardasil, the rival vaccine made by Merck & Co.

But Merck’s product, which has had a three-year head start in the U.S. market, got another boost yesterday when the committee urged the U.S. Food and Drug Administration to expand its approval for prevention of genital warts to a new market: males ages 9 to 26.

Both vaccines prevent infection with two types of human papillomavirus that cause about 80 percent of cervical cancers. Only Gardasil also protects against two types of HPV that cause 90 percent of genital warts.

While the FDA is not required to follow advisers’ recommendations, it usually does.

The latest endorsements will likely sharpen a rivalry with much local resonance. London-based GlaxoSmithKline P.L.C. directed much development of its vaccine at offices in the Philadelphia region, while Gardasil is made in and marketed from West Point, Montgomery County, home to Merck’s vaccine division.

The new studies also come as enthusiasm for HPV vaccination – hailed as a public health breakthrough three years ago – seems to be cooling amid persistent concerns about safety and questions about how long the vaccine protection will last. Gardasil’s sales slid 5 percent last year to $1.4 billion.

GlaxoSmithKline had submitted Cervarix clinical trial data and sought approval more than two years ago, but the FDA asked for more information. The agency was concerned that the vaccine’s novel “adjuvant” – a chemical that heightens immune response to the vaccine – might be triggering rare autoimmune diseases such as optic neuritis or Guillian-Barre syndrome.

In March 2009, GlaxoSmithKline submitted data from the single largest trial of a cervical cancer vaccine to date, with nearly 30,000 participants receiving Cervarix, some for as long as 6.4 years. The data showed that autoimmune diseases were not more common among vaccinated women than those in a control group.

GlaxoSmithKline also addressed another FDA concern – about spontaneous abortion. Although women were given a pregnancy test and told they should not be vaccinated if they were pregnant, about 7,200 got pregnant around the time of vaccination.

More spontaneous abortions occurred in the Cervarix group than the control group – 13 percent compared with about 9 percent – but this could have been by chance.

“I think we have to remember that both groups had lower spontaneous abortion rates than” normally occur in women in general, noted committee member Kenneth Noller, an obstetrician-gynecologist at Tufts University School of Medicine in Boston.

Like Gardasil, Cervarix is too new for scientists to know whether protection against HPV will last indefinitely. But Cervarix effectiveness data were clearly superior to those of Gardasil.

Like Gardasil, Cervarix was more than 90 percent effective at preventing precancerous lesions caused by the two “high-risk” HPV strains in women who had not been exposed to the virus before immunization. But Cervarix also was 75 percent effective at protecting against three cancer-causing HPV types that are not part of the vaccine, while Gardasil is only about 50 percent effective against one nonvaccine type.

In addition, blood tests showed that the concentration of virus-fighting antibodies was two to three times higher with Cervarix than with Gardasil – and remained high for 6.4 years.

By contrast, antibody levels fell back to natural pre-vaccination concentrations after two to three years in both males and females who had the Gardasil shots.

Merck officials say ongoing studies show that the vaccine remains effective in warding off warts and precancerous lesions despite the fall-off in antibodies. “But I would not tell you we’ll never need to give a booster shot” to Gardasil vaccines, Gregg Sylvester, Merck director of medical affairs for adult and adolescent vaccines, said in an interview after the hearing.

Others, like researcher Diana Zuckerman, say Gardasil is increasingly unappealing, especially considering that women have to continue to get regular Pap smears to screen for cervical cancer. Zuckerman is president of the National Research Center for Women and Families and a fellow at the University of Pennsylvania’s Center for Bioethics.

“Our center was excited when Gardasil was first approved, but the more we learned about how limited the data were, the more concerned we became,” she told the committee. “This is a very expensive vaccine – costing more than $400 – and we need to know how long it lasts. That’s true for women, and it’s even more true for men since the benefits are more limited. The boys of America are not facing an epidemic of genital warts.”[…]

Read the original article here.

Matthew Perrone, Associated Press: September 9, 2009

Printed in the Associated Press, The Houston Chronicle, San Francisco Examiner, and other newspapers across the country

WASHINGTON — Drugmaker Merck likely will face U.S. competition for its vaccine Gardasil, after federal experts recommended rival GlaxoSmithKline’s Cervarix also be approved to prevent the virus that causes most cervical cancers.

The FDA’s panel of vaccine experts voted overwhelmingly Wednesday that Cervarix appears safe and effective for girls and women ages 10 to 25. If the FDA follows the group’s advice as it usually does, Glaxo would begin competing against Merck’s Gardasil, which has controlled the U.S. market since 2006.

But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in boys, a new use for a vaccine that already posts sales of more than $1 billion.

While panelists favored the expanded approval, they questioned how widely the vaccine would be used, since genital warts are not a serious medical condition.

“Genital warts are a nuisance, they’re ugly and can sometimes be stigmatizing,” said Dr. Kenneth Noller, of Tufts University. “But in men and women with healthy immune systems they go away by themselves.”

The human papilloma virus, or HPV, infects about 6 million people in the U.S. each year, and is mainly spread through sexual contact. It usually causes no symptoms and goes away within two years, though rare cases can develop into warts and cancer in both men and women.

Last year nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all cancer related deaths.

London-based drugmaker Glaxo already has won approval for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data.

Panelists said newer studies suggest the vaccine is safe, but they recommended follow-up studies to monitor miscarriages and inflammatory-muscular problems reported by a small number of patients.

The group said it was unlikely those problems were related to the vaccine, but said the issues should still appear on product labeling.

“I think this could be marketed with the usual caveat that it’s not to be used during pregnancy,” Noller said.

Even if the FDA grants approval, Glaxo will face an uphill battle against competitor Merck. Besides an established brand in the U.S., Gardasil also boasts an extra degree of protection against sexually transmitted diseases.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 per cent of genital warts, something Cervarix does not target.

Leerink Swan analyst Seamus Fernandez estimates Cervarix will eventually make up 25-30 percent of the total market for HPV-blocking vaccines. Cervarix global sales were $231 million last year.

In separate votes Wednesday, FDA’s panel ruled that Gardasil successfully prevents genital warts in boys and men ages 9 to 26.

While an approval decision from the FDA could theoretically double the market opportunity for Gardasil, analysts don’t expect much use among males.

“If it’s not preventing something serious like cervical cancer and there are questions about safety, I think a parents’ acceptance of the vaccine in young boys might be less urgent than for their girls,” Fernandez said in an interview last week.

Gardasil became an early success story for Merck after its launch, with sales growing to over $1.4 billion last year.

But momentum has slowed amid questions about the longevity of the vaccine’s effect and its cost effectiveness, considering its price tag of nearly $400.

Merck has tracked HPV immunity out to five years in women, and just three years in boys and men. Public health advocates argued Gardasil should not be approved for boys without evidence of its long-term effectiveness.

“The boys of America are not facing an epidemic of genital warts,” said Diana Zuckerman, of the National Research Center for Women and Families in Washington, during a public comment period. “We have time to wait for better data before approval.”

Dr. Richard Haupt, Whitehouse Station, N.J.-based Merck’s head researcher for Gardasil, said the company plans long term studies to track the vaccine’s effectiveness over time.

“Our long term evaluations will look at immune response, but more importantly they will look at disease prevention over time,” said Haupt.

Matthew Perrone, Associated Press: September 4, 2009

WASHINGTON (AP) — Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck’s blockbuster Gardasil, which has controlled the U.S. market for three years.

In documents posted online, the Food and Drug Administration said Cervarix _ Glaxo’s vaccine against human papilloma virus or HPV _ successfully blocked the two leading strains of the virus nearly 93 percent of the time.

But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.

The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group’s advice, though it usually does.

While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.

Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men.

“If it’s not preventing something serious like cervical cancer and there are questions about safety, I think parents’ acceptance of the vaccine in young boys might be less urgent than for their girls,” said Fernandez.

Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment.

The FDA said Friday that outside experts have now determined Cervarix did not cause those problems.

“The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link,” the agency said in its review.

FDA reviewers also noted a slightly higher rate of miscarriages in women taking Cervarix, but said “the data do not establish a causal relationship.”

Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say London-based Glaxo may still have trouble making inroads into the U.S. market.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.

The most common side effects with both vaccines were pain and swelling at the injection site.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine’s effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period.

A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the “duration of protection of Gardasil has not been established.” Company trials have only tracked immunity out to five years after receiving the three-injection regimen.

Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26.

But the company is expected to face push-back next week from public health activists who already question the vaccine’s benefit for its main target market: women.

Some argue that $375 is too much to pay to protect against genital warts and diseases like penile cancer, which affect less than 1 percent of American men.

“It’s a lot of money for a little bit of extra protection from diseases that are not a big problem in this country,” said Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington. Zuckerman, who is scheduled to speak at next week’s meeting, says the additional use will do more to boost Merck’s sales than control HPV-related diseases.

“This is great for the company. The more people use this vaccine, the more money the company makes,” Zuckerman said.

Cancer of the penis and anus are extremely rare, with less than 2,000 cases reported annually. But Merck argues the cost of treating those cases is often underestimated.[…]

Jim Abrams, Associated Press: July 30, 2008

WASHINGTON (AP) – Dismayed by reports of millions of tainted toys, the House neared a vote Wednesday to ban lead and other dangerous chemicals from toys and other products that could wind up in kids’ mouths.

The legislation also would toughen rules for testing children’s products and take steps to give more muscle to the Consumer Product Safety Commission, which was criticized last year for its feeble handling of a flood of goods from China deemed hazardous to children.

“Congress is about to sign off on the most comprehensive product safety legislation in decades,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.

The bill, a product of House-Senate negotiations, would ban lead in products for children 12 or younger, and would ban – either permanently or pending further study – six types of phthalates, which are chemicals that are found in plastics and suspected of posing health risks.

House passage would send the measure to the Senate, which could approve it before Congress leaves for its August recess at the end of this week. The White House has voiced opposition to parts of the legislation but has not threatened a veto.

The bill would require third-party testing for many children’s products, a key change in monitoring practices following a year in which 45 million toys and children’s products – 30 million from China – were recalled.

Those included lead-contaminated children’s jewelry, “Spider-Man 3” flashing rings and Halloween pails.

“Third-party testing is a centerpiece of the new law” and a victory for consumers, said Ed Mierzwinski, consumer program director of U.S. PIRG, a grass-roots environmental organization.

The bill would double the budget of the Consumer Product Safety Commission, to $136 million by 2014, and give it new authority to impose civil penalties on violators. The CPSC was founded in 1973 with a staff of about 800. It now employs about half that number, while imports have vastly increased.

It also would boost whistleblower protections to encourage people to report hazards to the CPSC and would direct the agency to set up a database where consumers, government agencies, child care providers or doctors could report incidents of injury, illness, death or risk related to products.

One of the more controversial provisions is the ban on six types of phthalates, chemicals used in a wide range of products, including toys, to make vinyl soft and flexible. Tests on rats have found links to possible reproductive system problems for males and the onset of early puberty for females, and the European Union has banned the six.

Ami Gadhia of Consumers Union said infants are exposed to phthalates through toys, teethers and health care products. While there is no conclusive evidence that the chemical causes health problems in humans, she said a recent study found that mothers reported use of infant lotion, infant powder and shampoo was significantly associated with phthalate urinary concentrations.

But phthalates, said Sharon Kneiss of the American Chemistry Council, “are an important part of our everyday lives. There is no scientific basis for Congress to restrict phthalates from toys and children’s products.”

Under the new third-party testing regimen, a standards organization would set up and run a mandatory protocol that testing labs would have to meet to certify a product. No covered children’s product or toy could be imported without a certification mark. The CPSC has authority to approve and audit the certifications.

The negotiators also resolved to make more products now covered by voluntary industry standards subject to mandatory standards. That step added several potential toy hazards, including goods containing small magnets that were included in products recalled last year, subject to third-party testing requirements.

Among other provisions, the bill requires the CPSC to adopt safety standards on all-terrain vehicles and close a loophole where cribs sold secondhand were not subject to the same standards as new cribs.

The bill is H.R. 4040

Matthew Perrone, Associate Press: July 22, 2009

Gardiner Harris, New York Times: January 13, 2009

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.

The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.

“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.

In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.

The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.

Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”

“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.

Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.

He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.

A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”

Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zuckerman, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews. […]

Read the original article here.

Natasha Singer, New York Times: December 23, 2008

For many cancer patients undergoing mastectomies, reconstructive breast surgery can seem like a first step to reclaiming their bodies.

But even as promising new operations are gaining traction at academic medical centers, plastic surgeons often fail to tell patients about them. One reason is that not all surgeons have trained to perform the latest procedures. Another reason is money: some complex surgeries are less profitable for doctors and hospitals, so they have less of an incentive to offer them, doctors say.

“It is clear that many reconstruction patients are not being given the full picture of their options,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington.

One patient, Felicia Hodges, a 41-year-old magazine publisher in Newburgh, N.Y., chose a double mastectomy after she was found to have cancer of the right breast in 2004. She consulted a plastic surgeon, who offered her only reconstruction with breast implants, she said.

Ms. Hodges chose implants filled with saline, a procedure for which more than a third of reconstruction patients underwent a follow-up operation, studies show.

Ms. Hodges developed wound-healing problems that required her surgeon to remove her right implant, and she was left with a concave chest with a quarter-size hole in it, she said; she described the experience as “worse than the mastectomy.”

Then Ms. Hodges discovered a chat room on the patient-information Web site breastcancer.org, where women share detailed information about breast reconstruction beyond what they may have heard from their doctors.

Ms. Hodges learned of newer, more complex procedures that involve transplanting a wedge of fat and blood vessels from the abdomen or buttocks, which would be refashioned to form new breasts.

“It’s unfortunate that a lot of general surgeons, breast surgeons and plastic surgeons don’t mention it,” said Ms. Hodges, who underwent one of the surgeries, known as a GAP flap, last year. A lifelong athlete and a karate enthusiast, she is now back at her dojo.

To raise awareness of breast reconstruction and to market it to patients, the American Society of Plastic Surgeons has adopted the vocabulary of the movement to support a woman’s freedom to choose an abortion, adjusting it for women with breast cancer. Although women “don’t choose their diagnosis, they can choose to go ahead with reconstruction or not, and with the aid of a knowledgeable plastic surgeon they can choose what their options might be,” Dr. Linda G. Phillips, a plastic surgeon in Galveston, Tex., said in a telephone news conference organized by the plastic surgery society to mark Breast Cancer Awareness Month in October. “Then they have that much more power over their lives if they have that power to choose.”

But for many patients, the options may be limited because their doctors are not proficient in the latest procedures. Dr. Michael F. McGuire, the president-elect of the American Society of Plastic Surgeons, said it is not unusual for surgeons to omit telling patients about operations they do not perform. He compared the rise of more complex breast reconstruction to the advent in the late 1980s of minimally invasive laparoscopic surgery of the gallbladder.

“At the time, only a small percentage of surgeons were doing them and doing them well,” said Dr. McGuire, who is chief of plastic surgery at St. Johns Hospital in Santa Monica, Calif. “If you were not familiar with laparoscopic gallbladder surgery, you were still doing it the traditional way with an open great big scar across the abdomen.”

Uneven information about reconstructive options is a subset of a larger problem, said Dr. Amy K. Alderman, an assistant professor of plastic surgery at the University of Michigan Medical School in Ann Arbor. Only one third of women undergoing operations for breast cancer said their general surgeons had discussed reconstruction at all, according to a study by Dr. Alderman of 1,844 women in Los Angeles and Detroit that was published in February in the journal Cancer.

“In the big picture, it would be great if we could just get doctors to tell people they have an option of reconstruction,” Dr. Alderman said.

Once patients are so informed, she added, plastic surgeons should tell them of options beyond implants. “The next hurdle would be letting them know that using their own tissue is an option, because my guess is that they are not even getting that far in the discussion,” Dr. Alderman said.

About 66,000 women in the United States had mastectomies in 2006, the latest figures available, according to the federal government. And about 57,000 women had reconstructive breast surgery last year, according to estimates from the plastic surgery society.

For many of these women, the operations were more about feeling whole again than about restoring their appearance.

Implant surgery is the most popular reconstruction method in the United States. Often performed immediately after a mastectomy, it initially involves the least surgery ­ usually a short procedure to insert a temporary balloonlike device called an expander ­ and the shortest recovery time.

But implants come with the likelihood of future operations. Within four years of implant reconstruction, more than one third of reconstruction patients in clinical studies had undergone a second operation, primarily to fix problems like ruptures and infections, and a few for cosmetic reasons, according to studies submitted by implant makers to the Food and Drug Administration. (Reconstructive patients are more likely to develop complications after implant surgery than cosmetic patients with healthy breast tissue.)

Complication rates for newer flap procedures like the one Ms. Hodges had have not been well studied, though many surgeons say they are less likely to require follow-up operations. […]

Read the original article here.

Reed Abelson, New York Times: October 26, 2008

After a surgeon removed a cancerous lump from Karen Medlock’s breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring.

But he did not send her for the kind of radiation most women have received for decades.

Instead, the surgeon referred her to a center in Oakland, Calif., specializing in a newer form of treatment where radioactive “seeds” are inserted in the tumor site. It could be completed in only five days instead of the six weeks typically required for conventional treatment, which irradiates the entire breast using external beams.

To Ms. Medlock, it seemed an obvious choice. The newer treatment ­ given through a system called MammoSite ­ has been performed on about 45,000 breast cancer patients in this country since the Food and Drug Administration cleared it for use in 2002.

Only when Ms. Medlock, 49, sought a second opinion did she learn a startling truth: MammoSite is still highly experimental.

The MammoSite system is among the thousands of devices the F.D.A. lets onto the market each year after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. And because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted.

F.D.A. officials defend the quick-review process as a way to promote innovation. Because most new products are simply an improvement on an existing device, they say, there is rarely need for a full review.

Demanding lengthy study of such devices would be “very, very inappropriate and a waste of resources,” said Dr. Daniel G. Schultz, the director of the F.D.A.’s Center for Devices and Radiological Health.

The agency let MammoSite on the market on the basis of a study involving only 25 women that did not answer the fundamental question of how effective it is against breast cancer. Six years later, many cancer specialists say there is still no conclusive proof that it works as well as conventional radiation. The F.D.A. says it did require a label warning that the system had not been shown to be a substitute for conventional radiation.

Dr. Valery Uhl, the radiation oncologist who provided Ms. Medlock’s second opinion, outlined the evidence behind the available treatments. Ms. Medlock chose conventional external-beam radiation because of its well-documented record of success in preventing the return of cancer. To use an unproven therapy like MammoSite, Dr. Uhl said, “makes me really nervous.”

Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. While that process is not perfect, a new drug is typically studied in hundreds or even thousands of patients before the F.D.A. will approve it as safe and effective.

But under the fast-track review for most devices, a product’s effectiveness is never directly established. Regulators simply determine if the device does what its maker says it does ­ in MammoSite’s case, that it delivers radiation ­ and whether it poses any undue safety risks.

“Nobody is looking to see whether they help patients,” said Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”

In response to a Congressional request to study the effectiveness of the F.D.A.’s device-review process, the nonpartisan Government Accountability Office is expected to release a report next month.

Critics say that when the F.D.A. clears a device, the public may wrongly assume that the government has proof it is medically effective. F.D.A. approval has been “widely misinterpreted,” said Dr. Jay R. Harris, the chairman of radiation oncology at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

Differing Opinions

Dr. Dennis R. Hill, the doctor who originally saw Ms. Medlock, scoffs at the notion that MammoSite is in any way experimental. “It is a proven method,” he said. He said the oncologist who told Ms. Medlock it was experimental was skeptical because she provides only traditional radiation.

But the oncologist in question, Dr. Uhl, says she has performed many radioactive-seed treatments but wants to make sure patients are fully informed about the range of options.

Of the 250,000 women in this country who are found to have breast cancer each year, around 200,000 are candidates for radiation treatment if they choose to undergo a lumpectomy or partial removal of a breast. Most still get conventional radiation.

MammoSite proponents say that is because most doctors simply recommend the treatments they know best. “There is a natural bias for radiation oncologists to do what they have been doing,” said David Harding, an executive at Hologic Inc., the company in Bedford, Mass., that markets MammoSite.

Many prominent specialists, though, say the gold standard remains conventional radiation, for which breast cancer local recurrence rates are 3 percent or less at five years. Success in preventing cancer recurrence is measured in long intervals of 5 or 10 years or more, and there has been little long-term study of MammoSite.

Even a radiation oncologist who is a leading proponent of the MammoSite treatment, Dr. Frank A. Vicini, wants to know how it compares with traditional radiation. He is directing a national study of MammoSite’s effectiveness, but he cautions that it could take decades to conclude whether it should be used in lieu of conventional radiation.

“We have to make sure patients know we don’t have 30-year data,” said Dr. Vicini, the chief of oncological services for Beaumont Hospitals in Royal Oak, Mich. “We simply don’t.”

A System From the Past

The nation’s system for regulating medical devices was set up more than three decades ago, when devices played a much smaller role in medicine. A growing chorus of doctors, consumer advocates and health insurance executives say it is overdue for an overhaul.

The process has become “a barrier to evidence development,” said Dr. Winifred S. Hayes, whose firm, Hayes Inc., evaluates new health care technologies.

Although federal drug regulation dates back more than 100 years, medical devices did not come under the government’s purview until 1976, after Congress responded to deaths linked to the Dalkon Shield, an intrauterine contraceptive device.

Because the new law would not apply to devices on the market before 1976, Congress did not want makers of newer products to be at a competitive disadvantage. So lawmakers provided the quick review process for any new product deemed “substantially equivalent” to something already on the market. That expedited process became known as a 510(k) review under the relevant section of the law.

But critics say that what Congress intended as a way to let simple devices quickly enter the market has expanded so much that even critical therapies are cleared without enough research.

“It is supposed to be for the Band-aids of the world,” said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington advocacy group. “The 510(k) process should have been used less and less. It’s being used more.”

But defenders of the F.D.A. process, including the officials in charge of it, argue that tighter gatekeeping could deprive patients of promising alternatives. And they contend that most new medical devices introduced each year involve minor modifications to mundane items like thermometers.

To be sure, sophisticated devices like a new artificial hip or a novel heart stent do go through the same evidence-based scrutiny given to new drugs. Of the 41 medical devices that went through that full review last year and in which the F.D.A. reached a decision, 27 received approval.

But during those same 12 months, the F.D.A. reviewed 3,052 devices under the more cursory 510(k) process and cleared 2,640 of them. […]

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