NCLA Brief Asks DC Circuit to Stop FDA’s Improper Attempt to Regulate the Practice of Medicine

Washington, D.C., Nov. 24, 2020 (GLOBE NEWSWIRE) — The New Civil Liberties Alliance, a nonpartisan, nonprofit civil rights group, filed an amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit supporting a challenge to a Final Rule issued by the Food and Drug Administration (FDA). The Rule bans “electrical stimulation devices” (ESDs) for aversion therapy, currently in use in only one treatment facility in the United States—the Judge Rotenberg Educational Center in Canton, Massachusetts.

NCLA argues that the statute on which FDA relies does not provide FDA the rulemaking authority it seeks to exercise. Congress adopted the statute to permit FDA to move swiftly to prevent manufacturers from continuing to distribute fraudulent or hazardous medical devices commercially during the time it would take for FDA to prevail in a court proceeding. That rationale is inapplicable when, as here, no manufacturer is seeking to distribute the devices targeted by FDA commercially.

The Center’s professional staff seeks only to continue to use the devices it manufactured many years ago to deter severe self-injurious or aggressive behavior in its own patients. Under those circumstances, the sole enforcement measure available to FDA is a lawsuit seeking an injunction and seizure of the devices—a course of action that would at least have provided Petitioners the hearing rights they were denied in the rulemaking proceeding.

For decades, Massachusetts courts have deemed that the Center’s aversion therapy is both safe and effective for hundreds of patients. Thus, fearing that a federal court would reject its “unreasonable and substantial risk” claim, FDA opted to pursue a rulemaking proceeding. By proceeding in this fashion, for only the third time in its history, FDA was able to prevent the Center from cross-examining FDA’s witnesses and from effectively responding to the assertions FDA made to support its finding.

FDA seeks to prevent the Center from continuing to use its ESDs, but FDA’s rule will allow substantially similar medical devices to continue being used to treat other medical conditions, such as for smoking cessation. NCLA is deeply concerned that FDA has violated the petitioners’ procedural rights and has arrogated to itself powers not delegated to it by Congress. NCLA is asking the court to vacate the rule. 

NCLA released the following statement: 

“Not only is the FDA acting in bad faith, but it’s interfering with the practice of medicine by attempting to dictate how the Center must treat its patients. The law that permits hearing-less bans would violate due process rights—and thus would be simply unconstitutional.”

Rich Samp, Senior Litigation Counsel, NCLA

ABOUT NCLA

NCLA is a nonpartisan, nonprofit civil rights group founded by prominent legal scholar Philip Hamburger to protect constitutional freedoms from violations by the Administrative State. NCLA’s public-interest litigation and other pro bono advocacy strive to tame the unlawful power of state and federal agencies and to foster a new civil liberties movement that will help restore Americans’ fundamental rights.

 

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Waltham Dentist Ordered to Stop False Advertising …

Waltham Dentist Ordered to Stop False Advertising

Yesterday, on Monday, November 23, 2020, Waltham dentist Dr. Jeffrey S. Cummings, doing business at 520 Main Street in Waltham, was ordered to stop falsely advertising he is currently affiliated with and a member of a national organization, the American Academy of Cosmetic Dentistry (the “AACD”). It is unknown when the false advertising began, but Dr. Cummings had a large sign outside his building for years, shown here in a photo of his office building address from the Apartments.com site, advertising he does “Cosmetic” and “Implant” Dentistry.

AACD was contacted by a former patient of Dr. Cummings, who in turn immediately contacted Dr. Cummings. The former patient had checked the AACD online directory at https://aacd.com/profiles to find out if Dr. Cummings is actually listed at AACD as an AACD member, since he advertises such an affiliation on his website bio page and on his stationary. But he was not listed as a member on the AACD website.

By yesterday evening, the false advertising on his website bio page was removed, following the demand from AACD to Dr. Cummings to remove it.

On the AACD website, this national organization describes itself as follows:

“The American Academy of Cosmetic Dentistry® (AACD) is dedicated to advancing excellence in the art and science of comprehensive cosmetic dentistry and encouraging the highest standards of ethical conduct and responsible patient care.”

AACD has different levels of membership for dentists, some of which require a substantial amount of work for a dentist to claim an affiliation. As to their policy on dentists advertising an affiliation when no such affiliation exists with AACD, their membership director, Dana J. Murn, had this to say in an email:

“…we contact those who are using our logo and claiming to be a member.”

According to Ms. Murn, a complaint of a dentist falsely advertising an affiliation with AACD goes “to our Ethics department.”

It is unclear whether Dr. Cummings had malpractice insurance during the time he was falsely advertising an affiliation with AACD.

According to the MA Board of Dentistry, Massachusetts is a state that does NOT require evidence of malpractice insurance for a dentist. When contacted about this, Barbara A. Young, RDH, Executive Director, Mass. Board of Registration in Dentistry, stated in an email:

“The Board does not require a dentist to carry malpractice insurance …. Since this policy is not required by the Board, we do not track whether a dentist does or does not carry malpractice coverage.”

The name of the former patient of Dr. Cummings who contacted AACD and the MA Board of Dentistry is not being disclosed in this article because the patient has a right to privacy of records.

False advertising is illegal in Massachusetts and is recognized as a deceptive business practice. Dentists are supposed to be truthful in their communications as required by the American Dental Association Code of Ethics, which is part of the licensing test for dentists in the Commonwealth of Massachusetts.

It is

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COVID is killing health care workers. Where’s the outrage? Why don’t we try to stop this?

In the United States, we value the lives of those who protect us. According to the FBI, 89 law enforcement officers died in line-of-duty incidents last year. Each of those deaths is a tragedy, often marked by funeral processions of hundreds of squad cars from around the country. We mourn those deaths because we know the officers died protecting us. Perhaps that’s one reason we see so many “Defend the Police” yard signs.

What would the country do if more than 1,000 police officers — more than a tenfold increase — died in a single year? There would be outcries from the White House and both sides of the political aisle. We’d see House and Senate hearings to identify who was at fault, what was wrong and how to safeguard our police. Those hearings would culminate in a bill to provide new funding and equipment to protect our law enforcement officers. The bill proudly would be signed in an Oval Office ceremony amid great fanfare.

Yet during COVID-19, we’re seeing a group of public servants dying in the line of duty with comparatively little fanfare. As of last week, 1,336 health care worker deaths from COVID-19 exposure on the job have been reported to an investigative database. Another study using more inclusive criteria puts the total at hundreds more.

Recipe for disaster, lost lives

The victims range from food service workers to nurses to specialist physicians. Health care worker deaths are not tracked as systematically as law enforcement deaths, but a 2002 study found that 80-260 health care workers die annually of work-related infections. If correct, that suggests COVID-19 has caused about a tenfold increase in those deaths — the same increase that would provoke political outrage if it struck police officers. Yet after the initial flurry of “support our heroes” signs early in the pandemic, health care worker deaths have drawn comparatively little attention.

The obvious question, the one the Trump administration should be asking, is why this is occurring. Several factors contribute, but the most important is that the more COVID-19 cases occur, the more COVID-19 patients require health care, especially those most ill. The more patients are receiving health care, the more health care workers are exposed. And the more health care workers are exposed, the more likely that some of them will acquire on-the-job infections.

National COVID-19 Remembrance on Oct. 4, 2020, in Washington, D.C.
National COVID-19 Remembrance on Oct. 4, 2020, in Washington, D.C.

The answer to the question “Why have so many health care workers died in the U.S.?” is simple: “Because our national leaders have so mismanaged the outbreak.” When you have an administration that degrades its own public health scientists, denies the value of masks and social distancing that has been so effective around the world, and misleads the public as to the seriousness of the COVID-19 pandemic, that’s a recipe for disaster that has claimed over 1,300 people who committed themselves to our health.

COVID-19: My stepfather died alone as Trump throws unmasked rallies

America’s own Government Accountability Office

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As the Virus Rages, Some Are Convinced It’s Too Late to Stop It

COEUR d’ALENE, Idaho — The congregation of Candlelight Christian Fellowship gathered around tables in the church sanctuary one night last week to sip coffee and grapple with theological questions. From down the hall came the laughter of dozens of children at play.

With a potluck dinner, no masks and plenty of shared hugs, the night felt like a throwback to the pre-pandemic era except for a noticeable exception on the stage: The lead pastor, Paul Van Noy, was addressing the congregation with the aid of supplemental oxygen, piped into his nostrils from a small tank.

About a month ago, Mr. Van Noy, 60, was discharged from a hospital in a wheelchair after a Covid-19 infection brought him to the brink of death. But while that scare ravaged his lungs and rattled the church, it has done little to alter the growing sentiment among many people in northern Idaho that the coronavirus cannot be stopped and efforts to contain it are doing more harm than good.

“I think we just open up and we just let it take its course,” said Nancy Hillberg, 68, as church members mingled after the service. “Just let it be done.”

Amid a record spike of coronavirus cases and the final days of the presidential election, President Trump and his administration have expressed increasing helplessness at containing the virus, focusing instead on improvements in survivability and trying to hold the economy together. While it is a theme welcomed by many of the president’s supporters, it has proved alarming to health officials, including those at the hospital that cared for Mr. Van Noy, who are encountering rising resistance to their calls for unity in combating a pandemic that has already claimed nearly 230,000 Americans and threatens to take many more.

In northern Idaho, which is facing record cases and hospitalizations, the local health board last month repealed a requirement that people wear masks in Kootenai County, where Candlelight Christian Fellowship is.

“I personally do not care whether anybody wears a mask or not,” Walt Kirby, a member of the board, said at a public hearing on the issue. “If they want to be dumb enough to walk around out there and expose themselves and others to this, that’s fine with me.

“I’m just sitting back and watching them catch it and die. Hopefully I’ll live through it.”

In an interview later, Mr. Kirby said that he initially supported the mask mandate as a strategy to contain the virus and that, at age 90, he wears one whenever he is out in public.

But the mask requirement resulted in immense backlash, he said, in a part of the country where many people moved to escape what they see as an overbearing government.

Governors around the country, particularly Republican ones, are following the president’s lead in resisting new restrictions against a virus that has powerfully persisted despite lockdowns in some areas over the spring and summer.

Gov. Kristi Noem of South Dakota wrote that “there is no way

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Poland’s Constitutional Court Has Effectively Banned Abortion, But We Will Not Stop Fighting For Our Fundamental Rights

Polish Abortion Protests Continue - Day Seven
Polish Abortion Protests Continue – Day Seven

A Pro-Choice activist holds a smoke flare during a protest in Krakow’s Market Square. Women’s rights activists and their supporters staged their seventh day of protests in Krakow and all over Poland, opposing pandemic restraint, to express their anger at the ruling of Polish Supreme Court, which tightened the already strict abortion laws. Credit – Artur Widak—NurPhoto via Getty Images

Poland’s anti-abortion laws have always been among the most restrictive in Europe. Until this week the procedure was only permitted when the pregnancy posed a threat to the woman’s life; if there was a fatal fetal abnormality or in cases rape or incest.

However on Oct. 22 the country’s constitutional court ruled that a fatal fetal abnormality was not justification for terminating a pregnancy and violates the constitution. For the over 10 million women of reproductive age in Poland, this ruling effectively puts in place a complete ban on abortion.

According to official data, just over 1,100 legal abortions are performed annually in Poland–98% of which are in cases of fatal fetal abnormalities. The procedure prevented further pain and suffering for both the woman and the fetus.

While the court’s ruling has not yet come into force, many Polish hospitals have already stopped carrying out terminations. Women with scheduled procedures are having their appointments canceled. Women with a diagnosis of fatal fetal abnormality are not being provided with information and don’t know where to find help, left alone with their tragic news. At the Federation for Women and Family Planning we are getting calls from men asking for help for their wives or partners. The women are often so devastated they are unable to speak.

We try to support them as much as possible and there are some doctors who support them too. After our campaigning some hospitals have again begun to perform abortions but it is only a drop in the ocean of what is needed.

The ruling is an outrageous violation of women’s human rights. Women are being treated like living incubators. We do not have any rights, not even the fundamental human rights guaranteed by the Polish Constitution: the right to health, the right to private life, the right to equal treatment.

Not one word was said in defense of women during the debate. The fetus, called the “conceived child,” has the rights of an already existing life. During the Tribunal’s debate the most cruel statement was that we cannot “kill a conceived child” just because its birth would “reduce the comfort of a woman’s life.”

Forcing a woman to give birth to a child with severe, irreversible conditions is cruelty. Whether or not to keep the pregnancy should be the decision of the woman, or the woman and her partner. They will be the only ones to bear the traumatic consequences of this decision.

The politicians of the ruling party in Poland allowed the politicized Tribunal to issue what is a cruel and shameful decision. They hoped that the

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Melania Trump misleads on Trump’s record in joint campaign stop

The first lady told Florida rallygoers at her first campaign event with her husband in 2020 that “health care for every citizen remains a priority for him, and as you have seen over these past years, he won’t stop until he gets it done.”

But in reality, Trump has made repealing the Affordable Care Act a cornerstone of his candidacy and presidency, pledging back in 2016 that he would undo the law that not only gave millions of Americans access to health insurance, but also provided protections for those with pre-existing conditions and entitled people to receive free preventive health care services.

The Trump administration is currently fighting in court to strike down the ACA and has yet to release a comprehensive health care plan to replace it.
If the court wipes away Obamacare, it would have a sweeping impact on the nation’s health care system and on the lives of tens of millions of Americans — not only for the roughly 20 million people who’ve gained coverage on the Affordable Care Act exchanges and through the expansion of Medicaid to low-income adults. The law is also what allows parents to keep their children on their health insurance plans until age 26 and obtain free mammograms, cholesterol checks and birth control.
One of its most popular provisions is its strong protections for those with pre-existing conditions, including barring insurers from denying coverage or charging higher premiums based on people’s health histories. As part of what he touted as his larger health care “vision,” the President signed an executive order in September stating that it’s US policy that people who suffer from pre-existing conditions will be protected. But that protection likely won’t mean much if there’s no legislation passed by Congress ready to replace the ACA if it’s overturned. The law also serves as a safety net for those who lose their job-based health coverage, as millions have this year amid pandemic-fueled layoffs.
And despite the first lady’s assertion that “health care for every citizen,” her husband has been largely critical of universal health care plans.

In her swing state pitch less than a week before Election Day, the first lady focused largely on the President’s accomplishments from his first term and echoing some of her husband’s campaign themes.

“For those of you still deciding who to vote for on Tuesday, I hope what I have to say will prove to you that a vote for President Trump is a vote for a better America,” the first lady said.

She also criticized those who are playing politics with a coronavirus vaccine, but her remarks were delivered to a crowd of supporters where social distancing was not observed and masks were largely not worn.

“A vaccine is not a partisan issue. If you are not supporting the safe production of a vaccine, you’re not supporting the health and safety of the American people,” she said. “There is no room to play politics on this topic in the midst of [a] pandemic.”

“On

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Why We Need to Stop Linking Beauty and Success With ‘Fair’ Skin

From depictions of ‘suitable’ marriage partners in Netflix series Indian Matchmaking to the on-going popularity of skin-lightening creams, colourism remains rife in certain communities. Here, writer Ayesha Muttucumaru details her complicated relationship with the word ‘fair’ – and why calling out shade bias is vital.



From Indian Matchmaking to the popularity of skin lightening creams, colourism is still rife. Here's why we need to about skin lightening creams


© Provided by Women’s Health UK
From Indian Matchmaking to the popularity of skin lightening creams, colourism is still rife. Here’s why we need to about skin lightening creams

They dropped the F-Bomb.’ From the moment my mum and I started watching Indian Matchmaking on Netflix, we felt it would only be a matter of time until the word that makes us wince like no other was uttered. The term in question? No, not a four lettered expletive, but something far more insidious. ‘Fair.’



a woman smiling for the camera: The author


The author

As you might know, the docu-series follows ‘Mumbai’s top matchmaker,’ Sima Taparia, as she helps a range of single people in India and the US, with the help of their families, find their future wife or husband. The format has proven divisive. Criticisms levied by certain members of the Indian diaspora on Twitter include that some of the show’s participants engage in caste-discrimintion, mostly using euphemistic terms (‘from a good family’, ‘similar backgrounds’), as well as colourism (a prejudice or discrimination towards those with dark skin that usually occurs within the same ethnic group).

The latter is seen when some participants request a match with ‘fair’ skin. As well as affecting those with darker complexions in south Asian communities, it should be noted that attitudes such as these can lead people down a dangerous road to anti-Blackness.

These statements, some said, go unchallenged by Taparia, which could lead to the normalisation or affirmation of such views. (Speaking to The Cut, Smriti Mundhra, the show’s executive producer, said that she welcomes critique: ‘We’re now at a point where we can actually hold representation to a higher standard and push for better and more nuanced stories. I want to be held accountable. Push me so I can push too.’)

Why the word ‘fair’ is problematic

As to why the word ‘fair’ is an issue? Short story: it is not just seen as a way to denote someone’s appearance, but a character trait, having become synonymous with a person’s place in society, their chances of professional success, status and self-worth. The connotations go far beyond the superficial.

Sounds archaic, right? However, seeing one US-based show contestant casually list: ‘not too dark’ and ‘fair skin’ as a preferred ‘want’ in a potential parter was a stark reminder that colourism seems to be very much alive and kicking, even in my millennial generation.

The history of colourism in south Asian communities

Colonialism and the caste system are two of the reasons attributed to enduring colourist attitudes, as is the way skin colour is portrayed in the film industry, the media and by beauty brands. One notable example is the ‘fairness’ cream Fair & Lovely whose advertisements in India have historically implied that

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Protect Good Medicine, Stop the Censorship of Good Counseling

An increasing number of children, both here in America and around the globe, are experiencing deep discomfort, confusion, and alienation from their sexed body, a condition known as gender dysphoria. Unsurprisingly, people disagree about how best to respond to this condition in order to help these kids. How we navigate that disagreement will prove critical.

Some people insist that the proper course of action involves experimental interventions directed at the boy or girl’s body itself—puberty-blocking drugs, cross-sex hormones, and surgery. Others suggest that therapy be directed to the child’s thoughts and feelings, not the body.

Physical interventions on minors to “affirm” a mistaken “gender identity” violate sound medical ethics and should be prohibited. And yet, in all fifty states, such interventions are entirely legal.

At the same time, a more radical movement is seeking to make it illegal to use a psychological approach to help these children rather than a hormonal and surgical one. An increasing number of jurisdictions—both in the US and in other countries—are banning therapy that aims to help minors with gender dysphoria feel comfortable about their own bodies without transforming their bodies. Federal legislation has been introduced that would create nationwide censorship of such therapy, and the UN has claimed that such therapy violates human rights.

This turns medical ethics—and the law—upside down. Good therapy should never be prohibited. Children deserve access to the therapeutic assistance they need to feel comfortable being what they are as a plain and ineradicable matter of biological fact: male or female. And parents have a natural right to seek this care for their children.

What’s Wrong with Therapy Bans

Some argue that any attempt to help children feel comfortable and thrive as the sex they are, without transforming their bodies, is not good medicine, and they accuse practitioners of using abusive, harmful techniques. But they never provide credible evidence, and the therapy bans they support don’t target harmful practices. Instead, they prohibit working toward goals and outcomes that sexual progressive activists oppose. That is, these therapy bans aren’t focused on techniques that cause harm, but on certain objectives being sought—namely, being comfortable with one’s body.

As a result, one-on-one counseling to help a teen struggling with body image due to anorexia would be permitted, but the very same counseling would be prohibited if the goal is to help a teen struggling with body image due to gender dysphoria.

Activists use emotionally charged language, labelling all such techniques “conversion therapy.” They do not apply this label only to certain discredited techniques (such as electro-shock therapies), but to any therapeutic service—including basic talk therapy—to help a gender dysphoric youth feel comfortable without “transitioning.” Their argument is that if the true “gender identity” of the child is not being “affirmed,” then the child is being harmed. They claim that if a boy who “identifies” as a girl is helped to be comfortable with his actual and unalterable bodily sex, then “conversion therapy” is taking place—regardless of the counseling techniques deployed.

What

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Coronavirus Vaccine ‘Unlikely’ To Stop Infection Of COVID-19, Top UK Scientist Says

KEY POINTS

  • A UK chief scientific adviser said a vaccine will unlikely eradicate the novel coronavirus
  • His best assessment is that COVID-19 “will look more like an annual flu”
  • His comments come as the UK prepares to launch a human challenge vaccine trial

A coronavirus vaccine is unlikely to prevent the spread of the virus and stop it from becoming an endemic, according to Patrick Vallance, chief scientific adviser to the U.K. government. 

The British physician on Monday said none of the potential vaccines currently in late-stage trials might be able to eradicate COVID-19. 

During a meeting with the National Security Strategy Committee, Vallance said it is unlikely that the world will receive a sterilizing vaccine that can completely stop the infection. He also noted that only smallpox has been “truly eradicated” by highly effective vaccines. 

“The notion of eliminating COVID from anywhere is not right, because it will come back,” Vallance said. “We can’t be certain, but I think it’s unlikely we will end up with a truly sterilizing vaccine; [that is] something that completely stops infection, and it’s likely this disease will circulate and be endemic, that’s my best assessment.”

According to Intermountain Healthcare, the word “endemic” means it has a constant presence in a particular community or country. Such is the case with malaria, which is endemic to parts of Africa.

“Clearly as management becomes better, as you get vaccination which would decrease the chance of infection and the severity of disease … this then starts to look more like annual flu than anything else, and that may be the direction we end up going,” Vallance added.

His comments come as the U.K. prepares to launch a controversial human challenge trial where young and healthy volunteers between ages 18 and 30 would be intentionally exposed to COVID-19 to test the vaccine’s effectiveness. 

According to ABC News, the experiment will be conducted in a quarantine ward in a hospital located in North London. Participants will be asked to inhale a diluted dose of the virus. They will be monitored by scientists and doctors, including Andrew Catchpole, the chief scientist of hVIVO. The company will run the trials in collaboration with the British government. 

“So the virus, which we would inoculate them with, has been manufactured to the very high standards, a medical grade version of the virus that undergoes very high regulatory scrutiny to make sure that that virus is safe and suitable for use — just like you would expect for any other licensed medicine,” he said. 

Companies and governments are racing to develop vaccines in a bid to arrest the pandemic Companies and governments are racing to develop vaccines in a bid to arrest the pandemic Photo: AFP / Yasin AKGUL

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Should I Stop My Diabetes Medicine? FDA Hearings to Determine Risk of Heart Attack

Today marks the beginning of FDA hearings on Avandia (rosiglitazone), a popular drug for diabetes. The hearing centers on whether Avandia places a patient at higher risk of a heart attack.

Patients taking Avandia may not realize that one of the primary reasons doctors use Avandia is not only to lower one’s blood sugar, but to thereby prevent heart attacks. Thus the question is highly relevant for every diabetic taking this medication.

There is no question that Avandia lowers blood sugar – that is easily proven. The blood glucose-lowering effects can be demonstrated over the course of weeks and months, with evidence of on-going decrease in blood sugar levels for years. And since it is well known that high blood sugar (diabetes) is associated with increased risk of heart attacks, it is only logical that lowering blood sugar levels should decrease the risk of heart attack (myocardial infarction).

Yet this is not necessarily so. Might Avandia be doing something else as yet unidentified within the body? This is often the case with drugs. In fact, it has long been known that taking Avandia increases the risk of liver problems. That is why your doctor checks the liver enzymes in your blood frequently. In certain patients Avandia also causes fluid retention that in some cases is associated with congestive heart failure. Clearly, Avandia does do something in the body besides lower blood sugar, but the question remains, which is more dangerous: to take the medicine or not?

There are many medications on the market for diabetes. Of course, insulin is the prototype and some might think the final answer. But patients do not like to inject themselves and so a number of oral medicines have been developed. Also, taking insulin tends to cause weight gain in Type 2 diabetics, and since weight gain is a big part of the problem to begin with, to some degree it worsens the situation.

Knowing all this, should you stop taking Avandia? At this point the answer is we don’t know. Since the drug was released I have seen a very few patients suffer from excess fluid retention, but since that problem was recognized, the drug has not been advised for patients with swelling or heart failure. To date, only a few of my patients have had abnormal liver tests, and these have all been reversible with discontinuation of the drug. For my patients, Avandia has been effective at lowering blood sugars.

Yet the question remains, what about heart attacks? This week the FDA will be reviewing data from scientific trials regarding the use of Avandia (rosiglitazone), as well as health claims data related to its use. When all the information is gathered, statisticians and physicians will have more accurate information on which to make an informed decision. If we already knew the answer, the hearings would be unnecessary.

But what should you do in the meantime? Here is one way to think about the problem: if the answer has not become clear over 10 …

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